Blueprint
Filed
pursuant to Rule 424(b)(3)
Registration No. 333-227448
and Registration No. 333-227794
PROSPECTUS SUPPLEMENT NO. 16
(To
Prospectus dated October 12, 2018)
INTELLIPHARMACEUTICS INTERNATIONAL INC.
Common Shares
This
Prospectus Supplement No. 16 (this "Prospectus Supplement") amends
and supplements our Prospectus dated October 12, 2018, as
previously supplemented (the "Prospectus"), which form a part of
our Registration Statement (our "Registration Statement") on Form
F-1 (Registration Nos. 333-227448 and 333-227794). This Prospectus
Supplement is being filed to update, amend and supplement the
information included or incorporated by reference in the Prospectus
with the information contained in this Prospectus Supplement. The
Prospectus and this Prospectus Supplement relate to the public
offering of common shares issuable upon the exercise of warrants,
pre-funded warrants and underwriter’s warrants issued in the public
offering of securities which closed on October 16,
2018.
This
Prospectus Supplement includes certain information from our Report
on Form 6-K, which was filed with the Securities and Exchange
Commission on February 22, 2019.
This
Prospectus Supplement should be read in conjunction with the
Prospectus, except to the extent that the information in this
Prospectus Supplement updates and supersedes the information
contained in the Prospectus.
NEITHER THE U.S. SECURITIES AND EXCHANGE COMMISSION (THE "SEC") NOR
ANY STATE SECURITIES COMMISSION OR CANADIAN SECURITIES REGULATOR
HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF
THIS PROSPECTUS SUPPLEMENT IS TRUTHFUL OR COMPLETE. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
_______________
The
date of this Prospectus Supplement is February 26,
2019
2018 Year
End
Management
Discussion and Analysis
MANAGEMENT
DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FOR
THE YEAR ENDED NOVEMBER 30, 2018
The following
Management Discussion and Analysis (“MD&A”) should
be read in conjunction with the November 30, 2018 audited
consolidated financial statements of Intellipharmaceutics
International Inc. The audited consolidated financial statements
have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S.
GAAP”), as outlined in the Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification
(“ASC”). Our accounting policies have the potential to
have a significant impact on our audited consolidated financial
statements, either due to the significance of the financial
statement item to which they relate or because they require
judgment and/or estimation due to the uncertainty involved in
measuring, at a specific point in time, events which are continuous
in nature. The information contained in this document is current in
all material respects as of February 22, 2019 unless otherwise
noted.
Unless the context
otherwise requires, the terms “we”, “us”,
“our”, “Intellipharmaceutics”, and the
“Company” refer to Intellipharmaceutics International
Inc. and its subsidiaries. Any reference in this document to our
“products” includes a reference to our product
candidates and future products we may develop. Whenever we refer to
any of our current product candidates (including additional product
strengths of products we are currently marketing) and future
products we may develop, no assurances can be given that we, or any
of our strategic partners, will successfully commercialize or
complete the development of any of such product candidates or
future products under development or proposed for development, that
regulatory approvals will be granted for any such product candidate
or future product, or that any approved product will be produced in
commercial quantities or sold profitably.
Unless stated
otherwise, all references to “$” are to the lawful
currency of the United States and all references to
“C$” are to the lawful currency of Canada. We refer in
this document to information regarding potential markets for our
products, product candidates and other industry data. We believe
that all such information has been obtained from reliable sources
that are customarily relied upon by companies in our industry.
However, we have not independently verified any such
information.
Intellipharmaceutics™,
Hypermatrix™, Drug Delivery Engine™,
IntelliFoam™, IntelliGITransporter™,
IntelliMatrix™, IntelliOsmotics™, IntelliPaste™,
IntelliPellets™, IntelliShuttle™, nPODDDS™,
PODRAS™ and Regabatin™ are our trademarks. These
trademarks are important to our business. Although we may have
omitted the “TM” trademark designation for such
trademarks in this document, all rights to such trademarks are
nevertheless reserved. Unless otherwise noted, other trademarks
used in this document are the property of their respective
holders.
Unless the context
otherwise requires, references in this document to (i) share
amounts, per share data, share prices, exercise prices and
conversion rates have been adjusted to reflect the effect of the
1-for-10 reverse split which became effective on each of The NASDAQ
Capital Market (“Nasdaq”) and the Toronto Stock
Exchange (“TSX”) at the open of market on September 14,
2018, (ii) “consolidation” or “share
consolidation” are intended to refer to such reverse split,
and (iii) “pre-consolidation” and
“post-consolidation” are intended to refer to
“pre-reverse split” and “post-reverse
split”, respectively.
FORWARD-LOOKING
STATEMENTS
Certain statements
in this document constitute “forward-looking
statements” within the meaning of the United States Private
Securities Litigation Reform Act of 1995 and/or
“forward-looking information” under the Securities Act
(Ontario). These statements include, without limitation, statements
expressed or implied regarding our plans, goals and milestones,
status of developments or expenditures relating to our business,
plans to fund our current activities, and statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future sales,
revenues and profitability, projected costs and market penetration.
In some cases, you can identify forward-looking statements by
terminology such as “appear”, “unlikely”,
“target”, “may”, “will”,
“should”, “expects”, “plans”,
“plans to”, “anticipates”,
“believes”, “estimates”,
“predicts”, “confident”,
“prospects”, “potential”,
“continue”, “intends”, "look forward",
“could”, “would”, “projected”,
“set to”, “goals”, “seeking” or
the negative of such terms or other comparable terminology. We made
a number of assumptions in the preparation of our forward-looking
statements. You should not place undue reliance on our
forward-looking statements, which are subject to a multitude of
known and unknown risks and uncertainties that could cause actual
results, future circumstances or events to differ materially from
those stated in or implied by the forward-looking
statements.
Risks,
uncertainties and other factors that could affect our actual
results include, but are not limited to, the effects of general
economic conditions, securing and maintaining corporate alliances,
our estimates regarding our capital requirements and the effect of
capital market conditions and other factors, including the current
status of our product development programs, capital availability,
the estimated proceeds (and the expected use of any proceeds) we
may receive from any offering of our securities, the potential
dilutive effects of any future financing, potential liability from
and costs of defending pending or future litigation, our ability to
comply with the continued listing requirements of the principal
markets on which our securities are traded including risks or
uncertainties related to our ability to comply with the Nasdaq and
TSX continued listing standards and our ability to develop and
implement a plan of compliance with the Nasdaq continued listing
standards acceptable to a Nasdaq Panel, our programs regarding
research, development and commercialization of our product
candidates, the timing of such programs, the timing, costs and
uncertainties regarding obtaining regulatory approvals to market
our product candidates and the difficulty in predicting the timing
and results of any product launches, the timing and amount of
profit-share payments from our commercial partners, and the timing
and amount of any available investment tax credits. Other factors
that could cause actual results to differ materially include but
are not limited to:
●
the actual or
perceived benefits to users of our drug delivery technologies,
products and product candidates as compared to others;
●
our ability to
establish and maintain valid and enforceable intellectual property
rights in our drug delivery technologies, products and product
candidates;
●
the scope of
protection provided by intellectual property rights for our drug
delivery technologies, products and product
candidates;
●
recent and future
legal developments in the United States and elsewhere that could
make it more difficult and costly for us to obtain regulatory
approvals for our product candidates and negatively affect the
prices we may charge;
●
increased public
awareness and government scrutiny of the problems associated with
the potential for abuse of opioid based medications;
●
pursuing growth
through international operations could strain our
resources;
●
our limited
manufacturing, sales, marketing or distribution capability and our
reliance on third parties for such;
●
the actual size of
the potential markets for any of our products and product
candidates compared to our market estimates;
●
our selection and
licensing of products and product candidates;
●
our ability to
attract distributors and/or commercial partners with the ability to
fund patent litigation and with acceptable product development,
regulatory and commercialization expertise and the benefits to be
derived from such collaborative efforts;
●
sources of revenues
and anticipated revenues, including contributions from distributors
and commercial partners, product sales, license agreements and
other collaborative efforts for the development and
commercialization of product candidates;
●
our ability to
create an effective direct sales and marketing infrastructure for
products we elect to market and sell directly;
●
the rate and degree
of market acceptance of our products;
●
delays in product
approvals that may be caused by changing regulatory
requirements;
●
the difficulty in
predicting the timing of regulatory approval and launch of
competitive products;
●
the difficulty in
predicting the impact of competitive products on sales volume,
pricing, rebates and other allowances;
●
the number of
competitive product entries, and the nature and extent of any
aggressive pricing and rebate activities that may
follow;
●
the inability to
forecast wholesaler demand and/or wholesaler buying
patterns;
●
seasonal
fluctuations in the number of prescriptions written for our generic
Focalin XR® capsules which may produce substantial
fluctuations in revenue;
●
the timing and
amount of insurance reimbursement regarding our
products;
●
changes in laws and
regulations affecting the conditions required by the United States
Food and Drug Administration (“FDA”) for approval,
testing and labeling of drugs including abuse or overdose deterrent
properties, and changes affecting how opioids are regulated and
prescribed by physicians;
●
changes in laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical
products;
●
the effect of
recent changes in U.S. federal income tax laws, including but not
limited to, limitations on the deductibility of business interest,
limitations on the use of net operating losses and application of
the base erosion minimum tax, on our U.S. corporate income tax
burden;
●
the success and
pricing of other competing therapies that may become
available;
●
our ability to
retain and hire qualified employees;
●
the availability
and pricing of third-party sourced products and
materials;
●
challenges related
to the development, commercialization, technology transfer,
scale-up, and/or process validation of manufacturing processes for
our products or product candidates;
●
the manufacturing
capacity of third-party manufacturers that we may use for our
products;
●
potential product
liability risks;
●
the recoverability
of the cost of any pre-launch inventory should a planned product
launch encounter a denial or delay of approval by regulatory
bodies, a delay in commercialization, or other potential
issues;
●
the successful
compliance with FDA, Health Canada and other governmental
regulations applicable to us and our third party
manufacturers’ facilities, products and/or
businesses;
●
our reliance on
commercial partners, and any future commercial partners, to market
and commercialize our products and, if approved, our product
candidates;
●
difficulties,
delays, or changes in the FDA approval process or test criteria for
Abbreviated New Drug Applications (“ANDAs”) and New
Drug Applications (“NDAs”);
●
challenges in
securing final FDA approval for our product candidates, including
our oxycodone hydrochloride extended release tablets
(“Oxycodone ER”) product candidate in particular, if a
patent infringement suit is filed against us with respect to any
particular product candidates (such as in the case of Oxycodone
ER), which could delay the FDA’s final approval of such
product candidates;
●
healthcare reform
measures that could hinder or prevent the commercial success of our
products and product candidates;
●
the FDA may not
approve requested product labeling for our product candidate(s)
having abuse-deterrent properties and targeting common forms of
abuse (oral, intra-nasal and intravenous);
●
risks associated
with cyber-security and the potential for vulnerability of our
digital information or the digital information of a current and/or
future drug development or commercialization partner of
ours; and
●
risks arising from
the ability and willingness of our third-party commercialization
partners to provide documentation that may be required to support
information on revenues earned by us from those commercialization
partners.
Additional risks
and uncertainties relating to us and our business can be found in
our reports, public disclosure documents and other filings with the
securities commissions and other regulatory bodies in Canada and
the U.S. which are available on www.sedar.com and www.sec.gov. The forward-looking
statements reflect our current views with respect to future events,
and are based on what we believe are reasonable assumptions as of
the date of this document. We disclaim any intention and have no
obligation or responsibility, except as required by law, to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
This discussion
should not be construed to imply that the results discussed herein
will necessarily continue into the future, or that any conclusion
reached herein will necessarily be indicative of our actual
operating results.
CORPORATE
DEVELOPMENTS
●
On
February 21, 2019, the Company and its CEO, Dr. Isa Odidi, received
a Statement of Claim concerning an action against them in the
Superior Court of Justice of Ontario under the caption Victor Romita, plaintiff, and
Intellipharmaceutics International Inc and Isa Odidi,
defendants,. The action seeks certification as a class
action and alleges that certain public statements made by the
Company in the period February 29, 2016 to July 26, 2017 knowingly
or negligently contained or omitted material facts concerning the
Company’s NDA for Oxycodone ER abuse-deterrent oxycodone
hydrochloride extended release tablets. The plaintiff alleges that
he suffered loss and damages as a result of trading in the
Company’s shares on the Toronto Stock Exchange during the
above-noted period. The claim seeks, among other remedies,
unspecified damages, legal fees and court and other costs as the
court may permit. At this time, the action has not been certified
as a class action. The Company intends to vigorously defend against
the claims asserted in this action.
●
In February 2019,
we received tentative approval from the FDA for our ANDA for
desvenlafaxine extended-release tablets in the 50 and 100 mg
strengths. This product is a generic equivalent of the branded
product Pristiq® sold
in the U.S. by Wyeth Pharmaceuticals, LLC.
●
As more fully
described below (under “NASDAQ NOTICES AND NASDAQ
HEARINGS PANEL GRANT OF REQUEST FOR CONTINUED LISTING”), in
January 2019, we announced that we had received notice from the
Nasdaq Hearings Panel (the “Nasdaq Panel”) extending
the continued listing of our common shares until March 7, 2019,
subject to certain conditions, while we work to regain compliance
with Nasdaq’s requirements.
●
In January 2019, we
announced that we had commenced a research and development program
of pharmaceutical cannabidiol (“CBD”) based products.
As part of this research and development program, we filed
provisional patent applications with the United States Patent and
Trademark Office pertaining to the delivery and application of
cannabinoid-based therapeutics, began talks with potential
commercialization partners in the cannabidiol industry, and
identified a potential supplier of CBD. We hold a Health Canada
Drug Establishment License ("DEL") and a dealer's license under the
Narcotics Control Regulations ("NCR"). Under the NCR license, we
are currently authorized to possess, produce, sell and deliver drug
products containing various controlled substances, including CBD,
in Canada.
●
In November 2018,
we announced that we had received final approval from the FDA for
our ANDA for venlafaxine hydrochloride extended-release capsules in
the 37.5, 75 and 150 mg strengths. The approved product is a
generic equivalent of the branded product Effexor® XR sold in
the U.S. by Wyeth Pharmaceuticals, LLC. We are actively exploring
the best approach to maximize our commercial returns from this
approval.
●
In November 2018,
we announced that we had submitted an investigational new drug
("IND") application to the FDA for our oxycodone hydrochloride
immediate release ("IPCI006") tablets in the 5, 10, 15, 20 and 30
mg strengths. This novel drug formulation incorporates our
Paradoxical OverDose Resistance Activating System ("PODRAS™")
delivery technology and our novel Point Of Divergence Drug Delivery
System ("nPODDDS™") technology. IPCI006 is designed to
prevent, delay or limit the release of oxycodone hydrochloride when
more intact tablets than prescribed are ingested, thus delaying or
preventing overdose and allowing for sufficient time for a rescue
or medical intervention to take place. It is also intended to
present a significant barrier to abuse by snorting, "parachuting,"
injecting or smoking finely crushed oxycodone hydrochloride
immediate release tablets.
●
In November 2018,
we announced that we had entered into an exclusive licensing and
distribution agreement for our abuse resistant Oxycodone ER product
candidate and four generic drug products with a pharmaceutical
distributor in the Philippines. A Philippines-based pharmaceutical
distributor was granted the exclusive right, subject to regulatory
approval, to import and market our first novel drug formulation,
abuse-deterrent Oxycodone ER, in the Philippines. Additionally,
this distributor was granted, subject to regulatory approval, the
exclusive right to import and market our generic Seroquel XR®,
Focalin XR®, Glucophage® XR, and Keppra XR® in the
Philippines. Under the terms of the agreement, the distributor will
be required to purchase a minimum yearly quantity of all products
included in the agreement and we will be the exclusive supplier of
these products.
●
In November 2018,
we announced that we had entered into two exclusive licensing and
distribution agreements with pharmaceutical distributors in
Malaysia and Vietnam:
●
A
Malaysian pharmaceutical distribution company was granted the
exclusive right, subject to regulatory approval, to import and
market our generic Seroquel XR® (quetiapine fumarate
extended-release) in Malaysia. Under the terms of the agreement,
four strengths (50, 200, 300 and 400 mg) of generic Seroquel
XR® will be manufactured and supplied by us for distribution
in Malaysia. We are also in discussions to include other products
in the agreement with this distributor, who will be required to
purchase a minimum yearly quantity of all products included in the
agreement.
●
A
Vietnamese pharmaceutical distributor was granted the exclusive
right, subject to regulatory approval, to import and market our
generic Seroquel XR®, Glucophage® XR, and Keppra XR®
in Vietnam. Under the terms of the agreement, two strengths (500
and 750mg) of generic Glucophage® XR, three strengths (50, 150
and 200mg) of generic Seroquel XR® and one strength (500 mg)
of generic Keppra XR® will be manufactured and supplied by us
for distribution in Vietnam. The Vietnamese distributor will be
required to purchase a minimum yearly quantity of all products
included in the agreement.
●
In October 2018, we
completed an underwritten public offering in the United States,
resulting in the sale to the public of 827,970 Units at $0.75 per
Unit, which are comprised of one common share and one warrant (the
“2018 Unit Warrants”) exercisable at $0.75 per share.
We concurrently sold an additional 1,947,261 common shares and
warrants to purchase 2,608,695 common shares exercisable at $0.75
per share (the “2018 Option Warrants”) pursuant to the
over-allotment option exercised in part by the
underwriter. The price for the
common shares issued in connection with exercise of the
overallotment option was $0.74 per share and the price for the
warrants issued in connection with the exercise of the
overallotment option was $0.01 per warrant, less in each case the
underwriting discount. In addition, we issued 16,563,335 pre-funded
units (“2018 Pre-Funded Units”), each 2018 Pre-Funded
Unit consisting of one pre-funded warrant (a “2018 Pre-Funded
Warrant”) to purchase one common share and one warrant (a
“2018 Warrant”, and together with the 2018 Unit
Warrants and the 2018 Option Warrants, the “2018 Firm
Warrants”) to purchase one common share. The 2018 Pre-Funded
Units were offered to the public at $0.74 each and a 2018
Pre-Funded Warrant is exercisable at $0.01 per share. Each 2018
Firm Warrant is exercisable immediately and has a term of five
years and each 2018 Pre-Funded Warrant is exercisable immediately
and until all 2018 Pre-Funded Warrants are exercised. We also
issued warrants to the placement agents to purchase 1,160,314
common shares at an exercise price of $0.9375 per share (the
“October 2018 Placement Agent Warrants”), which were
exercisable immediately upon issuance. In aggregate, we issued
2,775,231 common shares, 16,563,335 2018 Pre-Funded Warrants and
20,000,000 2018 Firm Warrants in addition to 1,160,314 October 2018
Placement Agent Warrants.
●
In October 2018, we
announced that we had completed the clinical portion of our
Category 2 and 3 human abuse liability studies for our Oxycodone ER
product candidate to support its abuse-deterrent label claims for
both the oral and intranasal route of administration. Bioanalytical
samples and statistical analysis for such studies are pending.
Results from the studies will be included in our response to the
FDA Complete Response Letter which is due no later than February
28, 2019.
●
In September 2018,
we announced a one-for-ten share consolidation (the “reverse
split”). The reverse split was implemented in order to
qualify for continued listing on Nasdaq, whereby we have to meet
certain continued listing criteria, including a closing bid price
of at least $1.00 for a minimum of 10 consecutive business days. On
September 12, 2018, we filed articles of amendment which
implemented the reverse split, and our shares began trading on each
of Nasdaq and the TSX on a post-split basis under our existing
trade symbol “IPCI” at the market open on September 14,
2018. The reverse split reduced the number of outstanding common
shares from approximately 43.5 million to approximately 4.35
million at that time.
●
In September 2018,
we announced that we issued in a private placement financing (the
''2018 Debenture Financing'') an unsecured convertible debenture in
the principal amount of $0.5 million (the ''2018 Debenture''),
which will mature on September 1, 2020. The 2018 Debenture bears
interest at a rate of 10% per annum, payable monthly, is
pre-payable at any time at our option, and is convertible at any
time into common shares at a conversion price of $3.00 per common
share at the option of the holder. The 2018 Debenture Financing was
non-brokered and the net proceeds were used for working capital and
general corporate purposes.
●
In July 2018, we
announced that infringement claims related to one of the six
original patents included in the Purdue litigation were dismissed
without prejudice (as described below). As previously announced in
April 2017, we had received notice that Purdue Pharma L.P., Purdue
Pharmaceuticals L.P., The P.F. Laboratories, Inc., Rhodes
Technologies, and another party had commenced patent infringement
proceedings against us in the U.S. District Court for the District
of Delaware in respect of our NDA filing for Oxycodone ER. The
parties to the case mutually agreed to and did have dismissed
without prejudice the infringement claims related to the
Grünenthal ‘060 patent (which is one of the six patents
included in the original litigation case). On October 4, 2018, the
parties mutually agreed to postpone the scheduled court date
pending a case status conference scheduled for December 17, 2018.
At that time, further trial scheduling and other administrative
matters were postponed pending the Company’s anticipated
resubmission of the Oxycodone ER NDA to the FDA, which is due no
later than February 28, 2019.
●
In March 2018, we
announced the closing of two registered direct offerings. The first
offering consisted of 583,333 common shares at a price of $6.00 per
share for gross proceeds of approximately $3.5 million. We also
issued to the investors unregistered warrants to purchase an
aggregate of 291,666 common shares at an exercise price of $6.00
per share. The warrants became exercisable six months following the
closing date and will expire 30 months after the date they became
exercisable. After commissions and offering expenses, we received
net proceeds of approximately $3.0 million. We also issued to the
placement agents warrants to purchase 29,166 common shares at an
exercise price of $7.50 per share. In the second registered direct
offering, we issued 300,000 common shares at a price of $6.00 per
share for gross proceeds of $1.8 million. We also issued to the
investors unregistered warrants to purchase an aggregate of 150,000
common shares at an exercise price of $6.00 per share. The warrants
became exercisable six months following the closing date and will
expire 30 months after the date they became exercisable. After
commissions and offering expenses, we received net proceeds of
approximately $1.6 million. We also issued to the placement agents
warrants to purchase 15,000 common shares at an exercise price of
$7.50 per share.
●
In February 2018,
we met with the FDA to discuss a previously-announced Complete
Response Letter ("CRL") for Oxycodone ER, including issues related
to the blue dye in the product candidate. Based on those
discussions, the product candidate will no longer include the blue
dye. The blue dye was intended to act as an additional deterrent if
Oxycodone ER is abused and serve as an early warning mechanism to
flag potential misuse or abuse. The FDA confirmed that the removal
of the blue dye is unlikely to have any impact on formulation
quality and performance. As a result, we will not be required to
repeat in vivo bioequivalence studies and pharmacokinetic studies
submitted in the Oxycodone ER NDA. The FDA also indicated that,
from an abuse liability perspective, Category 1 studies will not
have to be repeated on Oxycodone ER with the blue dye
removed.
There
can be no assurance that our products will be successfully
commercialized or produce significant revenues for us. Also, there
can be no assurance that we will not be required to conduct further
studies for our Oxycodone ER product candidate, that the FDA will
approve any of our requested abuse-deterrence label claims or that
the FDA will ultimately approve the NDA for the sale of our
Oxycodone ER product candidate in the U.S. market, that we will be
successful in submitting any additional ANDAs or NDAs with the FDA
or ANDSs with Health Canada, that the FDA or Health Canada will
approve any of our current or future product candidates for sale in
the U.S. market and Canadian market, that any of our products or
product candidates will receive regulatory approval for sale in
other jurisdictions (including the Philippines, Malaysia and
Vietnam), that our desvenlafaxine extended-release will receive
final FDA approval, or that any of our products will ever be
successfully commercialized and produce significant revenue for us.
Furthermore, there can be no assurances regarding our ability to
comply with the Nasdaq continued listing standards acceptable to a
Nasdaq Panel, as described below. Moreover, there can be no
assurance that any of our provisional patent applications will
successfully mature into patents, or that any cannabidiol-based
product candidates we develop will ever be successfully
commercialized or produce significant revenue for us.
NASDAQ
NOTICES AND NASDAQ HEARINGS PANEL GRANT OF REQUEST FOR CONTINUED
LISTING
●
We are currently
not in compliance with the requirements for the continued listing
of our common shares on Nasdaq. As
described below, if we are not in compliance with those
requirements by March 7, 2019, a Nasdaq Hearing Panel will
determine whether we will be provided with an extension of time for
that purpose.
●
In
September 2017, we were notified by Nasdaq that we were not in
compliance with the minimum market value of listed securities
required for continued listing on Nasdaq. Nasdaq Listing Rule
5550(b) requires listed securities to maintain a minimum market
value of $35.0 million, among other alternatives, including minimum
stockholders’ equity of $2.5 million. A failure to meet the
minimum market value requirement exists if the deficiency continues
for a period of 30 consecutive business days. Based on the market
value of our common shares for the 30 consecutive business days
from August 8, 2017, we did not satisfy the minimum market value of
listed securities requirement. By rule, we were provided 180
calendar days, or until March 19, 2018, to regain compliance with
that requirement. To regain compliance, our common shares were
required to have a market value of at least $35.0 million for a
minimum of 10 consecutive business days prior to March 19, 2018,
which they did not. In the alternative, if the minimum market value
requirement for continued listing is not met, an issuer may
maintain continued listing under Nasdaq Listing Rule 5550(b) if it
has stockholders’ equity of at least $2.5
million.
●
On April 20, 2018,
we received notice that the Nasdaq Listings Qualification staff
(the “Nasdaq Staff”) had determined to delist our
common shares as a result of our failure to meet either the minimum
market value of listed securities requirement or the minimum
stockholders’ equity requirement for continued listing.
However, any delisting action by the Nasdaq Staff was stayed
pending the ultimate conclusion of our hearing before the Nasdaq
Panel.
●
In addition to not
meeting the minimum market value of listed securities or minimum
stockholders’ equity requirements, we were separately
notified in December 2017 that our common shares no longer
satisfied the minimum $1.00 per share bid requirement under Nasdaq
Listing Rule 5550(a)(2).
●
We
attended a hearing before the Nasdaq Panel on May 17, 2018, and
subsequently received formal notice that the Nasdaq Panel had
granted our request for continued listing provided that by
September 28, 2018, we (i) comply with Nasdaq’s $1.00 bid
price requirement by having a closing bid price of over $1.00 for
ten consecutive trading days, (ii) have stockholders’ equity
position of over $2.5 million, and (iii) provide the Nasdaq Panel
with updated financial projections demonstrating our ability to
maintain compliance with the stockholders’ equity rule for
the coming year. Following receipt of shareholder approval for a
reverse stock split (known as a share consolidation under Canadian
law) at our August 15, 2018 shareholders meeting, on September 12,
2018, we filed articles of amendment to effectuate a 1-for-10
reverse split, and our common shares began trading on each of
Nasdaq and the Toronto Stock Exchange on a post-reverse split basis
on September 14, 2018. As a result of the closing bid price of our
common shares exceeding $1.00 for the period from September 14,
2018 to September 27, 2018, we received a letter from Nasdaq
Listing Qualification notifying us that we had regained compliance
with Nasdaq’s minimum bid price requirement. On September 29,
2018, we were advised that the Nasdaq Panel granted an extension
through October 17, 2018 for us to regain compliance with
Nasdaq’s stockholders’ equity continued listing
requirement.
●
On
October 17, 2018, we filed with the Securities and Exchange
Commission (“SEC”) a report on Form 6-K reporting that
we believed we had regained compliance with Nasdaq’s
stockholders’ equity requirement after giving effect to the
proceeds from the October 2018 offering.
●
On October 26,
2018, we announced that we had regained compliance with
Nasdaq’s stockholders’ equity requirement and that the
Nasdaq's Panel determined that we would remain subject to a "Panel
Monitor” until October 22, 2019.
●
In November 2018,
we received written notification from Nasdaq notifying us that the
minimum bid price per share for our common shares was below $1.00
for a period of 30 consecutive business days and that, as a result,
we were not in compliance with Nasdaq’s minimum bid price
requirement.
●
In December 2018,
we received written notification from Nasdaq notifying us that a
hearing with a Nasdaq Panel had been scheduled for January 10,
2019.
●
At a hearing held
on January 10, 2019, we presented to the Nasdaq panel our plan to
regain and maintain compliance with Nasdaq’s continued
listing requirements.
●
On January 28,
2019, we announced that we had received notice from the Nasdaq
Panel extending the continued listing of our common shares until
March 7, 2019, subject to certain conditions, while we work to
regain compliance with Nasdaq’s requirements. Following the
March 7, 2019 deadline, the Nasdaq Panel will determine whether a
further extension period is warranted in the event we have not
regained compliance. However, there can be no assurance that the
Nasdaq Panel will grant such an extension. Moreover, there can be
no assurance that we will be able to regain compliance with
Nasdaq's requirements or, if we do, that we will be able to
maintain compliance with all applicable requirements for continued
listing on Nasdaq over the long term. The Nasdaq Panel's
determination requires us to promptly notify Nasdaq of any
significant events that occur during the extension period that may
affect our compliance with Nasdaq requirements.
BUSINESS
OVERVIEW
On October 22,
2009, Intellipharmaceutics Ltd. (“IPC Ltd.”) and
Vasogen Inc. (“Vasogen”) completed a court-approved
plan of arrangement and merger (the “IPC Arrangement
Agreement”), resulting in the formation of the Company, which
is incorporated under the laws of Canada and the common shares of
which are traded on the Toronto Stock Exchange and
Nasdaq.
We are a
pharmaceutical company specializing in the research, development
and manufacture of novel and generic controlled-release and
targeted-release oral solid dosage drugs. Our patented
Hypermatrix™ technology is a multidimensional
controlled-release drug delivery platform that can be applied to
the efficient development of a wide range of existing and new
pharmaceuticals. Based on this technology platform, we have
developed several drug delivery systems and a pipeline of products
(some of which have received FDA approval) and product candidates
in various stages of development, including ANDAs filed with the
FDA (and one ANDS filed with Health Canada) and one NDA filing, in
therapeutic areas that include neurology, cardiovascular,
gastrointestinal tract (“GIT”), diabetes and
pain.
In November 2005,
we entered into a license and commercialization agreement between
Par Pharmaceutical, Inc. (“Par”) and us (as amended on
August 12, 2011 and September 24, 2013, the “Par
agreement”), pursuant to which we granted Par an exclusive,
royalty-free license to make and distribute in the U.S. all
strengths of our generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules for a period of 10 years
from the date of commercial launch (which was November 19, 2013)
Under the Par agreement, we made a filing with the FDA for approval
to market generic Focalin XR® capsules in various strengths in
the U.S. (the “Company ANDA”), and are the owner of
that Company ANDA, as approved in part by the FDA. We retain the
right to make and distribute all strengths of the generic product
outside of the U.S. Calendar quarterly profit-sharing payments for
its U.S. sales under the Company ANDA are payable by Par to us as
calculated pursuant to the Par agreement. Within the purview of the
Par agreement, Par also applied for and owns an ANDA pertaining to
all marketed strengths of generic Focalin XR® (the “Par
ANDA”), and is now approved by the FDA, to market generic
Focalin XR® capsules in all marketed strengths in the U.S. As
with the Company ANDA, calendar quarterly profit-sharing payments
are payable by Par to us for its U.S. sales of generic Focalin
XR® under the Par ANDA as calculated pursuant to the Par
agreement.
We received final
approval from the FDA in November 2013 under the Company ANDA to
launch the 15 and 30 mg strengths of our generic Focalin XR®
capsules. Commercial sales of these strengths were launched
immediately by our commercialization partner in the U.S., Par. In
January 2017, Par launched the 25 and 35 mg strengths of its
generic Focalin XR® capsules in the U.S., and in May 2017, Par
launched the 10 and 20 mg strengths, complementing the 15 and 30 mg
strengths of our generic Focalin XR® marketed by Par. The FDA
granted final approval under the Par ANDA for its generic Focalin
XR® capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg
strengths, and subsequently Par launched the remaining 5 and 40 mg
strengths. Under the Par agreement, we receive quarterly profit
share payments on Par’s U.S. sales of generic Focalin
XR®. We currently expect revenues from sales of the generic
Focalin XR® capsules to continue to be impacted by ongoing
competitive pressures in the generic market. There can be no
assurance whether revenues from this product will improve going
forward or that any recently launched strengths will be
successfully commercialized. We depend significantly on the actions
of our marketing partner Par in the prosecution, regulatory
approval and commercialization of our generic Focalin XR®
capsules and on its timely payment to us of the contracted calendar
quarterly payments as they come due.
In February 2019,
we received tentative approval from the FDA for our ANDA for
desvenlafaxine extended-release tablets in the 50 and 100 mg
strengths. This product is a generic equivalent of the branded
product Pristiq® sold
in the U.S. by Wyeth Pharmaceuticals, LLC. There can be no
assurance that our desvenlafaxine extended-release tablets in the
50 and 100 mg strengths will receive final FDA approval or, if
approved, that they will be successfully commercialized and produce
significant revenue for us. We previously announced that we had
entered into a license and commercial supply agreement with
Mallinckrodt LLC ("Mallinckrodt"), which granted Mallinckrodt,
subject to its terms, an exclusive license to market, sell and
distribute in the U.S. the Company's desvenlafaxine
extended-release tablets (generic Pristiq®). Among other
things, the agreement provides for the Company to have a long-term
profit sharing arrangement with respect to the licensed product.
Intellipharmaceutics has agreed to manufacture and supply the
licensed product exclusively for Mallinckrodt on a cost-plus basis,
and Mallinckrodt has agreed that Intellipharmaceutics will be its
sole supplier of the licensed product marketed in the
U.S.
In November 2018,
we received final approval from the FDA for our ANDA for
venlafaxine hydrochloride extended-release capsules in the 37.5, 75
and 150 mg strengths. The approved product is a generic equivalent
of the branded product Effexor® XR sold in the U.S. by Wyeth
Pharmaceuticals, LLC. We are actively exploring the best approach
to maximize our commercial returns from this approval. There can be
no assurance that our generic Effexor XR® for the 37.5, 75 and
150 mg strengths will be successfully commercialized and produce
significant revenue for us.
In February 2017,
we received final approval from the FDA for our ANDA for metformin
hydrochloride extended release tablets in the 500 and 750 mg
strengths, a generic equivalent for the corresponding strengths of
the branded product Glucophage® XR sold in the U.S. by
Bristol-Myers Squibb. The Company is aware that several other
generic versions of this product are currently available that serve
to limit the overall market opportunity for this product. We have
been continuing to evaluate options to realize commercial returns
on this product, particularly in international markets. In November
2018, we announced that we entered into two exclusive licensing and
distribution agreements with pharmaceutical distributors in Vietnam
and the Philippines pursuant to which the distributors were
granted the exclusive right, subject to regulatory approval, to
import and market our generic Glucophage® XR in Vietnam and
the Philippines, respectively. There can be no assurance as to when
and if such product will receive regulatory approval for the sale
in Vietnam or the Philippines. Moreover, there can be no assurance
that our metformin hydrochloride extended release tablets will be
successfully commercialized and produce significant revenues for
us.
In February 2016,
we received final approval from the FDA of our ANDA for generic
Keppra XR® (levetiracetam extended-release) tablets for the
500 and 750 mg strengths. Our generic Keppra XR® is a generic
equivalent for the corresponding strengths of the branded product
Keppra XR® sold in the U.S. by UCB, Inc., and is indicated for
use in the treatment of partial onset seizures associated with
epilepsy. We are aware that several other generic versions of this
product are currently available that serve to limit the overall
market opportunity. We have been actively exploring the best
approach to maximize our commercial returns from this approval and
have been looking at several international markets where, despite
lower volumes, product margins are typically higher than in the
U.S. In November 2018, we announced that we entered into two
exclusive licensing and distribution agreements with pharmaceutical
distributors in Vietnam and the Philippines pursuant to which the
distributors were granted the exclusive right, subject to
regulatory approval, to import and market our generic Keppra
XR® in Vietnam and the Philippines, respectively. There can be
no assurance as to when and if such product will receive regulatory
approval for the sale in Vietnam or the Philippines. Moreover,
there can be no assurance that our generic Keppra XR® for the
500 and 750 mg strengths will be successfully
commercialized and produce significant revenues for
us.
In October 2016, we
received tentative approval from the FDA for our ANDA for
quetiapine fumarate extended-release tablets in the 50, 150, 200,
300 and 400 mg strengths, and in May 2017, our ANDA received final
FDA approval for all of these strengths. Our approved product is a
generic equivalent for the corresponding strengths of the branded
product Seroquel XR® sold in the U.S. by AstraZeneca
Pharmaceuticals LP (“AstraZeneca”). Pursuant to a
settlement agreement between us and AstraZeneca dated July 30,
2012, we were permitted to launch our generic versions of the 50,
150, 200, 300 and 400 mg strengths of generic Seroquel XR®, on
November 1, 2016, subject to FDA final approval of our ANDA for
those strengths. The Company manufactured and shipped commercial
quantities of all strengths of generic Seroquel XR® to our
marketing and distribution partner Mallinckrodt LLC
(“Mallinckrodt”), and Mallinckrodt launched all
strengths in June 2017.
In October 2016, we
announced a license and commercial supply agreement with
Mallinckrodt, granting Mallinckrodt an exclusive license to market,
sell and distribute in the U.S. the following extended release drug
product candidates (the "licensed products") which have either been
launched (generic Seroquel XR) or for which we have ANDAs filed
with the FDA (the “Mallinckrodt
agreement”):
■
Quetiapine fumarate
extended-release tablets (generic Seroquel XR®) –
Approved and launched
■
Desvenlafaxine
extended-release tablets (generic Pristiq®) – Tentative
approval received from the FDA
■
Lamotrigine
extended-release tablets (generic Lamictal® XR™) –
ANDA under FDA Review
Under the terms of
the 10-year agreement with Mallinckrodt, we received a
non-refundable upfront payment of $3 million in October 2016. In
addition, the agreement also provides for a long-term profit
sharing arrangement with respect to these licensed products (which
includes up to $11 million in cost recovery payments that are
payable on future sales of licensed product). We have agreed to
manufacture and supply the licensed products exclusively for
Mallinckrodt on a cost plus basis. The Mallinckrodt agreement
contains customary terms and conditions for an agreement of this
kind and is subject to early termination in the event we do not
obtain FDA approvals of the Mallinckrodt licensed products by
specified dates, or pursuant to any one of several termination
rights of each party. Upon the expiration of the initial term, and
absent any early termination actions, the Mallinckrodt agreement
will be automatically renewed for additional and consecutive terms
of one year (the 12-month period coinciding with
Mallinckrodt’s regularly established fiscal months), absent
notice of non-renewal given by one party to the other at least 180
days prior to the end of the initial or renewal term.
Our goal is to
leverage our proprietary technologies and know-how in order to
build a diversified portfolio of revenue generating commercial
products. We intend to do this by advancing our products from the
formulation stage through product development, regulatory approval
and manufacturing. We believe that full integration of development
and manufacturing will help maximize the value of our drug delivery
technologies, products and product candidates. We also believe that
out-licensing sales and marketing to established organizations,
when it makes economic sense, will improve our return from our
products while allowing us to focus on our core competencies. We
expect our expenditures for the purchase of production, laboratory
and computer equipment and the expansion of manufacturing and
warehousing capability to be higher as we prepare for the
commercialization of ANDAs, one NDA and one ANDS that are pending
FDA and Health Canada approval, respectively.
STRATEGY
Our
Hypermatrix™ technologies are central to the development and
manufacture of novel and generic controlled-release and
targeted-release oral solid dosage drugs. The Hypermatrix™
technologies are a multidimensional controlled-release drug
delivery platform that we believe can be applied to the efficient
development of a wide range of existing and new pharmaceuticals. We
believe that the flexibility of these technologies allows us to
develop complex drug delivery solutions within an
industry-competitive timeframe. Based on this technology platform,
we have developed several drug delivery systems and a pipeline of
products (some of which have received FDA approval) and product
candidates in various stages of development, including ANDAs filed
with the FDA (and one ANDS filed with Health Canada) and one NDA
filing, in therapeutic areas that include neurology,
cardiovascular, GIT, diabetes and pain. We expect that certain, but
not all, of the products in our pipeline may be developed from time
to time for third parties pursuant to drug development agreements
with those third parties, under which our commercialization partner
may pay certain of the expenses of development, make certain
milestone payments to us and receive a share of revenues or profits
if the drug is developed successfully to completion, the control of
which would generally be in the discretion of our drug development
partner.
The principal focus
of our development activities previously targeted
difficult-to-develop controlled-release generic drugs which follow
an ANDA regulatory path. Our current development effort is
increasingly directed towards improved difficult-to-develop
controlled-release drugs which follow an NDA 505(b)(2) regulatory
pathway. We have increased our research and development
(“R&D”) emphasis towards specialty new product
development, facilitated by the 505(b)(2) regulatory pathway, by
advancing the product development program for both Oxycodone ER and
RegabatinTM. We have also
identified several additional 505(b)(2) product candidates for
development in various indication areas including cardiovascular,
dermatology, pulmonary disease and oncology. The technology that is
central to our abuse deterrent formulation of our Oxycodone ER is
the nPODDDS™, or novel Point of Divergence Drug Delivery
System. nPODDDS™ is designed to provide for certain unique
drug delivery features in a product. These include the release of
the active substance to show a divergence in a dissolution and/or
bioavailability profile. The divergence represents a point or a
segment in a release timeline where the release rate, represented
by the slope of the curve, changes from an initial rate or set of
rates to another rate or set of rates, the former representing the
usually higher rate of release shortly after ingesting a dose of
the drug, and the latter representing the rate of release over a
later and longer period of time, being more in the nature of a
controlled-release or sustained action. It is applicable for the
delivery of opioid analgesics in which it is desired to discourage
common methods of tampering associated with misuse and abuse of a
drug, and also dose dumping in the presence of alcohol. It can
potentially retard tampering without interfering with the
bioavailability of the product.
In addition, our
PODRAS™, or Paradoxical OverDose Resistance Activating
System, delivery technology was initially introduced to enhance our
Oxycodone ER (abuse deterrent oxycodone hydrochloride extended
release tablets) product candidate. The PODRASTM delivery technology
platform was designed to prevent overdose when more pills than
prescribed are swallowed intact. Preclinical studies of prototypes
of oxycodone with PODRAS technology suggest that, unlike other
third-party abuse-deterrent oxycodone products in the marketplace,
if more tablets than prescribed are deliberately or inadvertently
swallowed, the amount of drug active released over 24 hours may be
substantially less than expected. However, if the prescribed number
of pills is swallowed, the drug release should be as expected.
Certain aspects of our PODRAS technology are covered by U.S. Patent
Nos. 9,522,119, 9,700,515, 9,700,516 and 9,801,939 and Canadian
Patent No. 2,910,865 issued by the U.S. Patent and Trademark Office
and the Canadian Intellectual Property Office in respect of
“Compositions and Methods for Reducing Overdose” in
December 2016, July 2017 and October 2017, respectively. The
issuance of these patents provides us with the opportunity to
accelerate our PODRAS™ development plan by pursuing proof of
concept studies in humans. We intend to incorporate this technology
in future product candidates, including Oxycodone ER and other
similar pain products, as well as pursuing out-licensing
opportunities. The Company is currently working on the development
of an Oxycodone immediate-release (IR) product incorporating this
technology.
The NDA 505(b)(2)
pathway (which relies in part upon the FDA’s findings for a
previously approved drug) both accelerates development timelines
and reduces costs in comparison to NDAs for new chemical entities.
An advantage of our strategy for development of NDA 505(b)(2) drugs
is that our product candidates can, if approved for sale by the
FDA, potentially enjoy an exclusivity period which may provide for
greater commercial opportunity relative to the generic ANDA
route.
The market we
operate in is created by the expiration of drug product patents,
challengeable patents and drug product exclusivity periods. There
are three ways that we employ our controlled-release technologies,
which we believe represent substantial opportunities for us to
commercialize on our own or develop products or out-license our
technologies and products:
●
For branded
immediate-release (multiple-times-per-day) drugs, we can formulate
improved replacement products, typically by developing new,
potentially patentable, controlled-release once-a-day drugs. Among
other out-licensing opportunities, these drugs can be licensed to
and sold by the pharmaceutical company that made the original
immediate-release product. These can potentially protect against
revenue erosion in the brand by providing a clinically attractive
patented product that competes favorably with the generic
immediate-release competition that arises on expiry of the original
patent(s). The regulatory pathway for this approach requires NDAs
via a 505(b)(2) application for the U.S. or corresponding pathways
for other jurisdictions where applicable.
●
Some of our
technologies are also focused on the development of abuse-deterrent
and overdose preventive pain medications. The growing abuse and
diversion of prescription “painkillers”, specifically
opioid analgesics, is well documented and is a major health and
social concern. We believe that our technologies and know-how are
aptly suited to developing abuse-deterrent pain medications. The
regulatory pathway for this approach requires NDAs via a 505(b)(2)
application for the U.S. or corresponding pathways for other
jurisdictions where applicable.
●
For existing
controlled-release (once-a-day) products whose active
pharmaceutical ingredients (“APIs”) are covered by drug
molecule patents about to expire or already expired, or whose
formulations are covered by patents about to expire, already
expired or which we believe we do not infringe, we can seek to
formulate generic products which are bioequivalent to the branded
products. Our scientists have demonstrated a successful track
record with such products, having previously developed several drug
products which have been commercialized in the U.S. by their former
employer/clients. The regulatory pathway for this approach requires
ANDAs for the U.S. and ANDSs for Canada.
We intend to
collaborate in the development and/or marketing of one or more
products with partners, when we believe that such collaboration may
enhance the outcome of the project. We also plan to seek additional
collaborations as a means of developing additional products. We
believe that our business strategy enables us to reduce our risk by
(a) having a diverse product portfolio that includes both branded
and generic products in various therapeutic categories, and (b)
building collaborations and establishing licensing agreements with
companies with greater resources thereby allowing us to share costs
of development and to improve cash-flow. There can be no assurance
that we will be able to enter into additional collaborations or, if
we do, that such arrangements will be commercially viable or
beneficial.
OUR
DRUG DELIVERY TECHNOLOGIES
HypermatrixTM
Our scientists have
developed drug delivery technology systems, based on the
Hypermatrix™ platform, that facilitate controlled-release
delivery of a wide range of pharmaceuticals. These systems include
several core technologies, which enable us to flexibly respond to a
wide range of drug attributes and patient requirements, producing a
desired controlled-release effect. Our technologies have been
incorporated in drugs manufactured and sold by major pharmaceutical
companies.
This group of drug
delivery technology systems is based upon the drug active
ingredient (“drug active”) being imbedded in, and an
integral part of, a homogeneous (uniform), core and/or coatings
consisting of one or more polymers which affect the release rates
of drugs, other excipients (compounds other than the drug active),
such as for instance lubricants which control handling properties
of the matrix during fabrication, and the drug active itself. The
Hypermatrix™ technologies are the core of our current
marketing efforts and the technologies underlying our existing
development agreements.
nPODDDSTM
In addition to
continuing efforts with Hypermatrix™ as a core technology,
our scientists continue to pursue novel research activities that
address unmet needs. Oxycodone ER (abuse deterrent oxycodone
hydrochloride extended release tablets) is an NDA candidate with a
unique long acting oral formulation of oxycodone intended to treat
moderate-to-severe pain. The formulation is intended to present a
significant barrier to tampering when subjected to various forms of
physical and chemical manipulation commonly used by abusers. It is
also designed to prevent dose dumping when inadvertently
co-administered with alcohol. The technology that supports our
abuse deterrent formulation of oxycodone is the nPODDDS™
Point of Divergence Drug Delivery System. The use of nPODDDS™
does not interfere with the bioavailability of oxycodone. We intend
to apply the nPODDDS™ technology platforms to other extended
release opioid drug candidates (e.g., oxymorphone, hydrocodone,
hydromorphone and morphine) utilizing the 505(b)(2) regulatory
pathway.
PODRASTM
Our Paradoxical
OverDose Resistance Activating System (PODRAS™) delivery
technology is designed to prevent overdose when more pills than
prescribed are swallowed intact. Preclinical studies of prototypes
of oxycodone with PODRAS technology suggest that, unlike other
third-party abuse-deterrent oxycodone products in the marketplace,
if more tablets than prescribed are deliberately or inadvertently
swallowed, the amount of drug active released over 24 hours may be
substantially less than expected. However, if the prescribed number
of pills is swallowed, the drug release should be as expected. We
are currently working on an alternate Oxycodone ER product
candidate incorporating our PODRAS™ delivery technology. In
April 2015, the FDA published Guidance for Industry: Abuse-Deterrent
Opioids — Evaluation and Labeling, which cited the
need for more efficacious abuse-deterrence technology. In this
Guidance, the FDA stated, “opioid products are often
manipulated for purposes of abuse by different routes of
administration or to defeat extended-release properties, most
abuse-deterrent technologies developed to date are intended to make
manipulation more difficult or to make abuse of the manipulated
product less attractive or less rewarding. It should be noted that
these technologies have not yet proven successful at deterring the
most common form of abuse—swallowing a number of intact
capsules or tablets to achieve a feeling of euphoria.” The
FDA reviewed our request for Fast Track designation for our abuse
deterrent Oxycodone ER development program incorporating
PODRAS™, and in May 2015 notified us that the FDA had
concluded that we met the criteria for Fast Track designation. Fast
Track is a designation assigned by the FDA in response to an
applicant’s request which meets FDA criteria. The designation
mandates the FDA to facilitate the development and expedite the
review of drugs intended to treat serious or life threatening
conditions and that demonstrate the potential to address unmet
medical needs.
In December 2016,
July 2017 and October 2017, U.S. Patent Nos. 9,522,119, 9,700,515,
9,700,516 and 9,801,939 and Canadian Patent No. 2,910,865 were
issued by the U.S. Patent and Trademark Office and the Canadian
Intellectual Property Office in respect of “Compositions and
Methods for Reducing Overdose”. The issued patents cover
aspects of the PODRAS™ delivery technology. The issuance of
these patents represents a significant advance in our abuse
deterrence technology platform. The PODRAS™ platform has the
potential to positively differentiate our technology from others of
which we are aware, and may represent an important step toward
addressing the FDA’s concern over the ingestion of a number
of intact pills or tablets. In addition to its use with opioids,
the PODRASTM platform is
potentially applicable to a wide range of drug products, inclusive
of over-the-counter drugs, that are intentionally or inadvertently
abused and cause harm by overdose to those who ingest them. We
intend to apply the PODRAS™ technology platforms to other
extended release opioid drug candidates (e.g., oxymorphone,
hydrocodone, hydromorphone and morphine) utilizing the 505(b)(2)
regulatory pathway.
PRODUCTS
AND PRODUCT CANDIDATES
The table below
shows the present status of our ANDA, ANDS and NDA products and
product candidates that have been disclosed to the
public.
Generic
name
|
Brand
|
Indication
|
Stage
of Development(1)`
|
Regulatory
Pathway
|
Market
Size (in millions)(2)
|
Rights(3)
|
Dexmethylphenidate hydrochloride extended-release
capsules
|
Focalin
XR®
|
Attention deficit
hyperactivity disorder
|
Received final
approval for 5, 10,15, 20, 25, 30, 35 and 40 mg strengths from
FDA(4)
|
ANDA
|
$851
|
Intellipharmaceutics
and Par (US)
Philippines rights
subject to licensing and distribution agreement
|
Levetiracetam extended-release tablets
|
Keppra XR®
|
Partial onset
seizures for epilepsy
|
Received final
approval for the 500 and 750 mg strengths from FDA
|
ANDA
|
$126
|
Intellipharmaceutics
Philippines and
Vietnamese rights subject to licensing and distribution
agreements
|
Venlafaxine hydrochloride extended-release capsules
|
Effexor XR®
|
Depression
|
Received final
approval for 37.5, 75 and 150 mg strengths from FDA
|
ANDA
|
$774
|
Intellipharmaceutics
|
Pantoprazole sodium delayed- release tablets
|
Protonix®
|
Conditions
associated with gastroesophageal reflux disease
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$367
|
Intellipharmaceutics
|
Metformin hydrochloride extended-release tablets
|
Glucophage® XR
|
Management of type
2 diabetes
|
Received final
approval for 500 and 750 mg strengths from FDA
|
ANDA
|
$388
(500 and 750 mg
only)
|
Intellipharmaceutics
Philippines and
Vietnamese rights subject to licensing and distribution
agreements
|
Quetiapine fumarate extended-release tablets
|
Seroquel XR®
|
Schizophrenia,
bipolar disorder & major depressive disorder
|
Received final FDA
approval for all 5 strengths. ANDS under review by Health
Canada
|
ANDA
|
$190
|
Intellipharmaceutics
and Mallinckrodt (US)
Philippines,
Malaysian and Vietnamese rights subject to licensing and
distribution agreements
|
Lamotrigine extended-release tablets
|
Lamictal® XR™
|
Anti-convulsant for
epilepsy
|
ANDA application
for commercialization approval for 6 strengths under review by
FDA
|
ANDA
|
$525
|
Intellipharmaceutics
and Mallinckrodt (US)
|
Desvenlafaxine extended-release tablets
|
Pristiq®
|
Depression
|
Received tentative
approval for the 50 and 100 mg strengths from FDA
|
ANDA
|
$279
|
Intellipharmaceutics
and Mallinckrodt (US)
|
Trazodone hydrochloride extended-release tablets
|
Oleptro™
|
Depression
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
N/A(5)
|
Intellipharmaceutics
|
Carvedilol phosphate extended- release capsules
|
Coreg CR®
|
Heart failure,
hypertension
|
Late-stage
development
|
ANDA
|
$66
|
Intellipharmaceutics
|
Oxycodone hydrochloride controlled-release capsules
|
OxyContin®
|
Pain
|
NDA application
accepted February 2017 and under review by FDA
|
NDA
505(b)(2)
|
$1,471
|
Intellipharmaceutics
Philippines rights
subject to licensing and distribution agreement
|
Pregabalin extended-release capsules
|
Lyrica®
|
Neuropathic
pain
|
IND
application submitted in August 2015
|
NDA
505(b)(2)
|
$5,425
|
Intellipharmaceutics
|
Ranolazine extended-release tablets
|
Ranexa®
|
Chronic
angina
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$1,013
|
Intellipharmaceutics
|
Oxycodone hydrochloride
immediate release tablets (IPCI006)
|
Roxicodone®
|
Pain
|
IND application
submitted in November 2018
|
NDA
505(b)(2)
|
$653
|
Intellipharmaceutics
|
Notes:
(1)
There can be no
assurance as to when, or if at all, the FDA or Health Canada will
approve any product candidate for sale in the U.S. or Canadian
markets.
(2)
Represents sales
for all strengths, unless otherwise noted, for the 12 months ended
January 2019 in the U.S., including sales of generics in TRx MBS
Dollars, which represents projected new and refilled prescriptions
representing a standardized dollar metric based on
manufacturer’s published catalog or list prices to
wholesalers, and does not represent actual transaction prices and
does not include prompt pay or other discounts, rebates or
reductions in price. Source: Symphony Health Solutions Corporation.
The information attributed to Symphony Health Solutions Corporation
herein is provided as is, and Symphony makes no representation
and/or warranty of any kind, including but not limited to, the
accuracy and/or completeness of such information.
(3)
For information
regarding the Par agreement, the Mallinckrodt agreement and the
licensing and distribution agreements with pharmaceutical
distributors in Malaysia, Vietnam and the Philippines, see the
“Business Overview” and the “Other Potential
Products and Markets” sections. There can be no assurance as
to when, or if at all, any of our products or product candidates,
as the case may be, will receive regulatory approval for sale in
the Philippines, Malaysia or Vietnam. For unpartnered products, we
are exploring licensing agreement opportunities or other forms of
distribution. While we believe that licensing agreements are
possible, there can be no assurance that any can be
secured.
(4)
Includes a Company
ANDA final approval for our 15 and 30 mg strengths, and a Par ANDA
final approval for their 5, 10, 15, 20, 25, 30, 35 and 40 mg
strengths. Profit sharing payments to us under the Par agreement
are the same irrespective of the ANDA owner.
(5)
Trazodone
Hydrochloride extended-release tablets are not currently being
marketed in the United States.
We typically select
products for development that we anticipate could achieve FDA or
Health Canada approval for commercial sales several years in the
future. However, the length of time necessary to bring a product to
the point where the product can be commercialized can vary
significantly and depends on, among other things, the availability
of funding, design and formulation challenges, safety or efficacy,
patent issues associated with the product, and FDA and Health
Canada review times.
Dexmethylphenidate
Hydrochloride – Generic Focalin
XR®(a
registered trademark of the brand manufacturer)
Dexmethylphenidate
hydrochloride, a Schedule II restricted product (drugs with a high
potential for abuse) in the U.S., is indicated for the treatment of
attention deficit hyperactivity disorder. In November 2005, we
entered into the Par agreement pursuant to which we granted Par an
exclusive, royalty-free license to make and distribute in the U.S.
all of our FDA approved strengths of our generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules for a
period of 10 years from the date of commercial launch (which was
November 19, 2013). We retain the right to make and distribute all
strengths of the generic product outside of the U.S. Calendar
quarterly profit-sharing payments for its U.S. sales of all
strengths of generic Focalin XR® are payable by Par to us as
calculated pursuant to the Par agreement.
We received final
approval from the FDA in November 2013 under the Company ANDA to
launch the 15 and 30 mg strengths of our generic Focalin
XR®
capsules. Commercial sales of these strengths were launched
immediately by our commercialization partner in the U.S., Par. Our
5, 10, 20 and 40 mg strengths were also then tentatively FDA
approved, subject to the right of Teva Pharmaceuticals USA, Inc. to
180 days of generic exclusivity from the date of first launch of
such products. In January 2017, Par launched the 25 and 35 mg
strengths of its generic Focalin XR® capsules in the
U.S., and in May 2017, Par launched the 10 and 20 mg strengths,
complementing the 15 and 30 mg strengths of our generic Focalin
XR®
marketed by Par. In November 2017, Par launched the remaining 5 and
40 mg strengths providing us with the full line of generic Focalin
XR® strengths available in the U.S. market.
In November 2018,
we announced that we entered into an exclusive licensing and
distribution agreement with a pharmaceutical distributor in the
Philippines pursuant to which the distributor was granted the
exclusive right, subject to regulatory approval, to import and
market our generic Focalin XR® in the Philippines. Under the
terms of the agreement, the distributor will be required to
purchase a minimum yearly quantity of our generic Focalin
XR® and we will be the exclusive supplier of such
product. This multi-year agreement is subject to early
termination.
There can be no
assurance as to when and if such product will receive regulatory
approval for the sale in the Philippines or that, if so approved,
the product will be successfully commercialized there and produce
significant revenues for us.
Levetiracetam – Generic Keppra
XR® (a registered
trademark of the brand manufacturer)
We received final
approval from the FDA in February 2016 for the 500 and 750 mg
strengths of our generic Keppra XR® (levetiracetam
extended-release) tablets. Keppra XR®, and the drug active
levetiracetam, are indicated for use in the treatment of partial
onset seizures associated with epilepsy. We are aware that several
other generic versions of this product are currently available and
serve to limit the overall market opportunity. We have been
actively exploring the best approach to maximize our commercial
returns from this approval and have been looking at several
international markets where, despite lower volumes, product margins
are typically higher than in the U.S.
In November 2018,
we announced that we entered into two exclusive licensing and
distribution agreements with pharmaceutical distributors in Vietnam
and the Philippines pursuant to which the distributors were granted
the exclusive right, subject to regulatory approval, to import and
market our generic Keppra XR® in Vietnam and the Philippines,
respectively. Under the terms of the agreements, the distributors
will be required to purchase a minimum yearly quantity of our
generic Keppra XR®. These multi-year agreements are each
subject to early termination.
There can be no
assurance that the Company's generic Keppra XR® for the 500
and 750 mg strengths will be successfully
commercialized. Further, there can be no assurance as to when
and if such product will receive regulatory approval for the sale
in Vietnam or the Philippines or that, if so approved, the product
will be successfully commercialized there and produce significant
revenues for us.
Venlafaxine hydrochloride – Effexor
XR® (a registered
trademark of the brand manufacturer)
We received final
approval from the FDA in November 2018 for our ANDA for venlafaxine
hydrochloride extended-release capsules in the 37.5, 75 and 150 mg
strengths. The approved product is a generic equivalent of the
branded product Effexor® XR sold in the U.S. by Wyeth
Pharmaceuticals, LLC. Effexor® XR, and the drug active
venlafaxine hydrochloride, are indicated for the treatment of major
depressive disorder (“MDD”). We are actively exploring
the best approach to maximize our commercial returns from this
approval. We are aware that several other generic versions of this
product are currently available and serve to limit the overall
market opportunity. There can be no assurance that the Company's
venlafaxine hydrochloride extended-release capsules for the 37.5
mg, 75 mg, and 150 mg will be successfully commercialized and
produce significant revenue for us.
Metformin hydrochloride –
Glucophage® XR (a
registered trademark of the brand manufacturer)
We received final
approval from the FDA in February 2017 for the 500 and 750 mg
strengths of our generic Glucophage® XR (metformin
hydrochloride extended release) tablets. Glucophage® XR, and
the drug active metformin, are indicated for use in the management
of type 2 diabetes treatment. The Company is aware that several
other generic versions of this product are currently available and
serve to limit the overall market opportunity, however, we are
continuing to evaluate options to realize commercial returns on
this product, particularly in international markets.
In November 2018,
we announced that we entered into two exclusive licensing and
distribution agreements with pharmaceutical distributors in Vietnam
and the Philippines pursuant to which the distributors were granted
the exclusive right, subject to regulatory approval, to import and
market our generic Glucophage® XR in Vietnam and the
Philippines, respectively. Under the terms of the agreements, the
distributors will be required to purchase a minimum yearly quantity
of our generic Glucophage® XR. These multi-year agreements are
each subject to early termination.
There can be no
assurance that our generic Glucophage® XR for the 500 and 750
mg strengths will be successfully commercialized. Further,
there can be no assurance as to when and if such product will
receive regulatory approval for the sale in Vietnam or the
Philippines or that, if so approved, the product will be
successfully commercialized there and produce significant revenues
for us.
Quetiapine fumarate extended-release tablets -
Generic Seroquel XR® (a registered trademark of the brand
manufacturer)
In October 2016, we
received tentative approval from the FDA for our ANDA for
quetiapine fumarate extended-release tablets in the 50, 150, 200,
300 and 400 mg strengths, and in May 2017, our ANDA received final
FDA approval for all of these strengths. Our approved product is a
generic equivalent for the corresponding strengths of the branded
product Seroquel XR® sold in the U.S. by AstraZeneca. Pursuant
to a settlement agreement between us and AstraZeneca dated July 30,
2012, we were permitted to launch our generic versions of the 50,
150, 200, 300 and 400 mg strengths of generic Seroquel XR®, on
November 1, 2016, subject to FDA final approval of our ANDA for
those strengths. Our final FDA approval followed the expiry of
180-day exclusivity periods granted to the first filers of generic
equivalents to the branded product, which were shared by Par and
Accord Healthcare. The Company manufactured and shipped commercial
quantities of all strengths of generic Seroquel XR® to our
marketing and distribution partner Mallinckrodt, and Mallinckrodt
launched all strengths in June 2017.
In November 2018,
we announced that we entered into three exclusive licensing and
distribution agreements with pharmaceutical distributors in
Malaysia, Vietnam and the Philippines pursuant to which the
distributors were granted the exclusive right, subject to
regulatory approval, to import and market our generic Seroquel
XR® in Malaysia, Vietnam and the Philippines, respectively.
Under the terms of the agreements, the distributors will be
required to purchase a minimum yearly quantity of our generic
Seroquel XR®. The multi-year agreements are each subject to
early termination. There can be no assurance as to when and if
such product will receive regulatory approval for the sale in
Malaysia, Vietnam or the Philippines or that, if so approved, the
product will be successfully commercialized there and produce
significant revenues for us.
Desvenlafaxine succinate extended-release
tablets – Generic Pristiq® (a registered trademark of the brand
manufacturer)
In February 2019,
we received tentative approval from the FDA for our ANDA for
desvenlafaxine extended-release tablets in the 50 and 100 mg
strengths. This product is a generic equivalent of the branded
product Pristiq® sold
in the U.S. by Wyeth Pharmaceuticals, LLC. There can be no
assurance that our desvenlafaxine extended-release tablets in the
50 and 100 mg strengths will receive final FDA approval or, if
approved, that they will be successfully commercialized and produce
significant revenue for us. We previously announced that we had
entered into a license and commercial supply agreement with
Mallinckrodt LLC ("Mallinckrodt"), which granted Mallinckrodt,
subject to its terms, an exclusive license to market, sell and
distribute in the U.S. the Company's desvenlafaxine
extended-release tablets (generic Pristiq®). Among other
things, the agreement provides for the Company to have a long-term
profit sharing arrangement with respect to the licensed product.
Intellipharmaceutics has agreed to manufacture and supply the
licensed product exclusively for Mallinckrodt on a cost-plus basis,
and Mallinckrodt has agreed that Intellipharmaceutics will be its
sole supplier of the licensed product marketed in the
U.S.
Oxycodone
ER (Abuse Deterrent Oxycodone Hydrochloride Extended-Release
Tablets)
One of our
non-generic products under development is our Oxycodone ER (abuse
deterrent oxycodone hydrochloride extended release tablets) product
candidate, intended as an abuse and alcohol-deterrent
controlled-release oral formulation of oxycodone hydrochloride for
the relief of pain. Our Oxycodone ER is a new drug candidate, with
a unique long acting oral formulation of oxycodone intended to
treat moderate-to-severe pain when a continuous, around the clock
opioid analgesic is needed for an extended period of time. The
formulation is intended to present a significant barrier to
tampering when subjected to various forms of physical and chemical
manipulation commonly used by abusers. It is also designed to
prevent dose dumping when inadvertently co-administered with
alcohol. Dose dumping is the rapid release of an active ingredient
from a controlled-release drug into the blood stream that can
result in increased toxicity, side effects, and a loss of efficacy.
Dose dumping can result by consuming the drug through crushing,
taking with alcohol, extracting with other beverages, vaporizing or
injecting. In addition, when crushed or pulverized and hydrated,
the proposed extended release formulation is designed to coagulate
instantaneously and entrap the drug in a viscous hydrogel, which is
intended to prevent syringing, injecting and snorting. Our
Oxycodone ER formulation is difficult to abuse through the
application of heat or an open flame, making it difficult to inhale
the active ingredient from burning.
In March 2015, we
announced the results of three definitive open label, blinded,
randomized, cross-over, Phase I pharmacokinetic clinical trials in
which our Oxycodone ER was compared to the existing branded drug
OxyContin® (extended release oxycodone hydrochloride) under
single dose fasting, single dose steady-state fasting and single
dose fed conditions in healthy volunteers. We had reported that the
results from all three studies showed that Oxycodone ER met the
bioequivalence criteria (90% confidence interval of 80% to 125%)
for all matrices, i.e., on the measure of maximum plasma
concentration or Cmax, on the measure of area under the curve time
(AUCt)
and on the measure of area under the curve infinity
(AUCinf).
In May 2015, the
FDA provided us with notification regarding our IND submission for
Oxycodone ER indicating that we would not be required to conduct
Phase III studies if bioequivalence to OxyContin® was
demonstrated based on pivotal bioequivalence studies.
In January 2016, we
announced that pivotal bioequivalence trials of our Oxycodone ER,
dosed under fasted and fed conditions, had demonstrated
bioequivalence to OxyContin® extended release tablets as
manufactured and sold in the U.S. by Purdue Pharma L.P.
(“Purdue”). The study design was based on FDA
recommendations and compared the lowest and highest strengths of
exhibit batches of our Oxycodone ER to the same strengths of
OxyContin®. The results show that the ratios of the
pharmacokinetic metrics, Cmax, AUC0-t and
AUC0-f
for Oxycodone ER vs OxyContin®, are within the interval of 80%
- 125% required by the FDA with a confidence level exceeding
90%.
In
July 2016, we announced the results of a food effect study
conducted on our behalf for Oxycodone ER. The study design was
a randomized, one-treatment two periods, two sequences, crossover,
open label, laboratory-blind bioavailability study for Oxycodone ER
following a single 80 mg oral dose to healthy adults under fasting
and fed conditions. The study showed that Oxycodone ER can be
administered with or without a meal (i.e., no food effect).
Oxycodone ER met the bioequivalence criteria (90% confidence
interval of 80% to 125%) for all matrices, involving maximum plasma
concentration and area under the curve (i.e., Cmax ratio of
Oxycodone ER taken under fasted conditions to fed conditions, and
AUC metrics taken under fasted conditions to fed conditions). We
believe that Oxycodone ER is well differentiated from currently
marketed oral oxycodone extended release products.
In November 2016,
we filed an NDA seeking authorization to market our Oxycodone ER in
the 10, 15, 20, 30, 40, 60 and 80 mg strengths, relying on the
505(b)(2) regulatory pathway which allowed us to reference data
from Purdue’s file for its OxyContin®. In February 2017,
the FDA accepted for filing our NDA, and set a Prescription Drug
User Fee Act (“PDUFA”) target action date of September
25, 2017. Our submission is supported by pivotal pharmacokinetic
studies that demonstrated that Oxycodone ER is bioequivalent to
OxyContin®. The submission also includes abuse-deterrent
studies conducted to support abuse-deterrent label claims related
to abuse of the drug by various pathways, including oral,
intra-nasal and intravenous, having reference to the FDA's
"Abuse-Deterrent Opioids - Evaluation and Labeling" guidance
published in April 2015.
Our NDA was filed
under Paragraph IV of the Hatch-Waxman Act, as amended. We
certified to the FDA that we believed that our Oxycodone
ER product
candidate would not infringe any of the OxyContin® patents
listed in the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly known as the Orange Book (the
“Orange Book”), or that such patents are invalid, and
so notified all holders of the subject patents of such
certification. On April 7, 2017, we received notice that Purdue,
Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc., or
collectively the Purdue parties, Rhodes Technologies, and
Grünenthal GmbH, or collectively the Purdue litigation
plaintiffs, had commenced patent infringement proceedings, or the
Purdue litigation, against us in the U.S. District Court for the
District of Delaware (docket number 17-392) in respect of our NDA
filing for Oxycodone ER, alleging that our proposed Oxycodone ER
infringes 6 out of the 16 patents associated with the branded
product OxyContin®, or the OxyContin® patents, listed in
the Orange Book. The complaint seeks injunctive relief as well as
attorneys' fees and costs and such other and further relief as the
Court may deem just and proper. An answer and counterclaim have
been filed.
Subsequent to the
above-noted filing of lawsuit, 4 further such patents were listed
and published in the Orange Book. We then similarly certified to
the FDA concerning such further patents. On March 16, 2018, we
received notice that the Purdue litigation plaintiffs had commenced
further such patent infringement proceedings adding the 4 further
patents. This lawsuit is also in the District of Delaware federal
court under docket number 18-404.
As a result of the
commencement of the first of these legal proceedings, the FDA is
stayed for 30 months from granting final approval to our Oxycodone
ER product candidate. That time period commenced on February 24,
2017, when the Purdue litigation plaintiffs received notice of our
certification concerning the patents, and will expire on August 24,
2019, unless the stay is earlier terminated by a final declaration
of the courts that the patents are invalid, or are not infringed,
or the matter is otherwise settled among the parties.
On or about June
26, 2018, the court issued an order to sever 6
“overlapping” patents from the second Purdue case, but
ordered litigation to proceed on the 4 new (2017-issued) patents.
An answer and counterclaim was filed July 9, 2018. The existence
and publication of additional patents in the Orange Book, and
litigation arising therefrom, is an ordinary and to be expected
occurrence in the course of such litigation.
On July 6, 2018,
the court issued a so-called “Markman” claim
construction ruling on the first case and the October 22, 2018
trial date remained unchanged. We believe that we have
non-infringement and/or invalidity defenses to all of the asserted
claims of the subject patents in both of the cases and will
vigorously defend against these claims.
On July 24, 2018,
the parties to the case mutually agreed to and did have dismissed
without prejudice the infringement claims related to the
Grünenthal ‘060 patent. The Grünenthal ‘060
patent is one of the six patents included in the original
litigation case, however, the dismissal does not by itself result
in a termination of the 30-month litigation
stay.
On October 4, 2018,
the parties mutually agreed to postpone the scheduled court date
pending a case status conference scheduled for December 17, 2018.
At that time, further trial scheduling and other administrative
matters were postponed pending the Company’s anticipated
resubmission of the Oxycodone ER NDA to the FDA, which is due no
later than February 28, 2019.
In June 2017, we
announced that a joint meeting of the Anesthetic and Analgesic Drug
Products Advisory Committee and Drug Safety and Risk Management
Advisory Committee of the FDA (the “Advisory
Committees”) meeting was scheduled for July 26, 2017 to
review our NDA for Oxycodone ER. The submission requested that our
Oxycodone ER product candidate include product label claims to
support the inclusion of language regarding abuse-deterrent
properties for the intravenous route of
administration.
In July 2017, the
Company announced that the FDA Advisory Committees voted 22 to 1 in
finding that the Company’s NDA for Oxycodone ER should not be
approved at this time. The committees also voted 19 to 4 that the
Company had not demonstrated that Oxycodone ER has properties that
can be expected to deter abuse by the intravenous route of
administration, and 23 to 0 that there was not sufficient data for
Oxycodone ER to support inclusion of language regarding
abuse-deterrent properties in the product label for the intravenous
route of administration. The committees expressed a desire to
review the additional safety and efficacy data for Oxycodone ER
that may be obtained from human abuse potential studies for the
oral and intranasal routes of administration.
In September 2017,
the Company received a CRL from the FDA for the Oxycodone ER NDA.
In its CRL, the FDA provided certain recommendations and requests
for information, including that Intellipharmaceutics complete
Category 2 and Category 3 studies to assess the abuse-deterrent
properties of Oxycodone ER by the oral and nasal routes of
administration. The FDA also requested additional information
related to the inclusion of the blue dye in the Oxycodone ER
formulation, which is intended to deter abuse. The FDA also
requested that Intellipharmaceutics submit an alternate proposed
proprietary name for Oxycodone ER. The FDA determined that it could
not approve the application in its present form. The FDA has
granted our request for an extension to February 28, 2019 to
resubmit our NDA for Oxycodone ER under section 505(b)(2) of the
U.S. Federal Food, Drug and Cosmetic Act.
In February
2018, the Company met with the FDA to discuss the above-referenced
CRL for Oxycodone ER, including issues related to the blue dye in
the product candidate. Based on those discussions, the product
candidate will no longer include the blue dye. The blue dye was
intended to act as an additional deterrent if Oxycodone ER is
abused and serve as an early warning mechanism to flag potential
misuse or abuse. The FDA confirmed that the removal of the blue dye
is unlikely to have any impact on formulation quality and
performance. As a result, the Company will not be required to
repeat in vivo bioequivalence studies and pharmacokinetic studies
submitted in the Oxycodone ER NDA. The FDA also indicated that,
from an abuse liability perspective, Category 1 studies will not
have to be repeated on Oxycodone ER with the blue dye
removed.
The abuse liability
studies for the intranasal route of abuse commenced in May 2018
with subject screening, while the studies to support
abuse-deterrent label claims for the oral route of abuse commenced
in June 2018. The clinical part of both studies has now been
completed. Bioanalytical testing and statistical analysis for such
studies are pending.
There can be no
assurance that the studies will be adequate, that we will not be
required to conduct further studies for Oxycodone ER, that the FDA
will approve any of the Company’s requested abuse-deterrence
label claims or that the FDA will ultimately approve our NDA for
the sale of Oxycodone ER in the U.S. market, or that it will ever
be successfully commercialized and produce significant revenue
for us
In November 2018,
we announced that we entered into an exclusive licensing and
distribution agreement with a pharmaceutical distributor in the
Philippines pursuant to which the distributor was granted the
exclusive right, subject to regulatory approval, to import and
market Oxycodone ER in the Philippines. Under the terms of the
agreement, the distributor will be required to purchase a minimum
yearly quantity of our Oxycodone ER and we will be the
exclusive supplier of our Oxycodone ER. This multi-year agreement
is subject to early termination. There can be no assurance as
to when and if such product candidate will receive regulatory
approval for the sale in the Philippines or that, if so approved,
the product will be successfully commercialized there and produce
significant revenues for us.
Regabatin™ XR (Pregabalin
Extended-Release)
Another
Intellipharmaceutics non-generic controlled-release product under
development is Regabatin™ XR, pregabalin extended-release
capsules. Pregabalin is indicated for the management of neuropathic
pain associated with diabetic peripheral neuropathy, postherpetic
neuralgia, spinal cord injury and fibromyalgia. A
controlled-release version of pregabalin should reduce the number
of doses patients take, which could improve patient compliance, and
therefore possibly enhance clinical outcomes. Lyrica®
pregabalin, twice-a-day ("BID") dosage and three-times-a-day
("TID") dosage, are drug products marketed in the U.S. by Pfizer
Inc. In October 2017, Pfizer also received approval for a Lyrica
CR, a controlled-release version of pregabalin. In 2014, we
conducted and analyzed the results of six Phase I clinical trials
involving a twice-a-day formulation and a once-a-day formulation.
For formulations directed to certain indications which include
fibromyalgia, the results suggested that Regabatin™ XR 82.5
mg BID dosage was comparable in bioavailability to Lyrica® 50
mg (immediate-release pregabalin) TID dosage. For formulations
directed to certain other indications which include neuropathic
pain associated with diabetic peripheral neuropathy, the results
suggested that Regabatin™ XR 165 mg once-a-day dosage was
comparable in bioavailability to Lyrica® 75 mg BID
dosage.
In March 2015, the
FDA accepted a Pre-Investigational New Drug (“Pre-IND”)
meeting request for our once-a-day Regabatin™ XR non-generic
controlled release version of pregabalin under the NDA 505(b)(2)
regulatory pathway, with a view to possible commercialization in
the U.S. at some time following the December 30, 2018 expiry of the
patent covering the pregabalin molecule. Regabatin™ XR is
based on our controlled release drug delivery technology platform
which utilizes the symptomatology and chronobiology of fibromyalgia
in a formulation intended to provide a higher exposure of
pregabalin during the first 12 hours of dosing. Based on positive
feedback and guidance from the FDA, we submitted an IND application
for RegabatinTM XR in August 2015.
The FDA completed its review of the IND application and provided
constructive input that we will use towards further development of
the program. We believe our product candidate has significant
additional benefits to existing treatments and are currently
evaluating strategic options to advance this
opportunity.
There can be no
assurance that any additional Phase I or other clinical trials we
conduct will meet our expectations, that we will have sufficient
capital to conduct such trials, that we will be successful in
submitting an NDA 505(b)(2) filing with the FDA, that the FDA will
approve this product candidate for sale in the U.S. market, or that
it will ever be successfully commercialized.
Oxycodone
Hydrochloride IR Tablets ("IPCI006") (Abuse Deterrent and
Overdose Resistant Oxycodone Hydrochloride Immediate Release
Tablets) – ROXICODONE®
In November 2018,
we announced that we had submitted an IND application to the FDA
for our IPCI006 oxycodone hydrochloride immediate release tablets
in the 5, 10, 15, 20 and 30 mg strengths. This novel drug
formulation incorporates the Company's PODRAS™, or
Paradoxical OverDose Resistance Activating System, delivery
technology and its nPODDDS™, or novel Point Of Divergence
Drug Delivery System, technology. IPCI006 is designed to prevent,
delay or limit the release of oxycodone hydrochloride when more
intact tablets than prescribed are ingested, thus delaying or
preventing overdose and allowing for sufficient time for a rescue
or medical intervention to take place. It is also intended to
present a significant barrier to abuse by snorting, "parachuting,"
injecting or smoking finely crushed oxycodone hydrochloride
immediate release tablets. The data generated from the studies
conducted under this IND is expected to form part of an NDA seeking
FDA approval for IPCI006 tablets.
If approved,
IPCI006 may be the first immediate release formulation of oxycodone
hydrochloride intended to simultaneously prevent or delay overdose
and prevent abuse by intranasal or intravenous routes.
There can be no
assurance that we will be successful in submitting any NDA with the
FDA, that the FDA will approve the Company's IPCI006 product
candidate for sale in the U.S. market or any related
abuse-deterrent label claims, or that it will ever be successfully
commercialized and produce significant revenue for us.
Other Potential Products and
Markets
We are continuing
our efforts to identify opportunities internationally, particularly
in China, that could if effectuated provide product distribution
alternatives through partnerships and therefore would not likely
require an investment or asset acquisition by us. Discussions
toward establishing a partnership to facilitate future development
activities in China are ongoing. We have not at this time entered
into and may not ever enter into any such
arrangements.
In addition, we are
seeking to develop key relationships in several other international
jurisdictions where we believe there may be substantial demand for
our generic products. These opportunities could potentially involve
out-licensing of our products, third-party manufacturing supply and
more efficient access to pharmaceutical ingredients and therefore
assist with the development of our product pipeline.
In November 2018,
we announced that we had entered into an exclusive licensing and
distribution agreement for our abuse resistant Oxycodone ER product
candidate and four generic drug products with a pharmaceutical
distributor in the Philippines. Under the terms of the agreement
the distributor was granted the exclusive right, subject to
regulatory approval, to import and market our first novel drug
formulation, abuse-deterrent Oxycodone ER, in the Philippines.
Additionally, this distributor was granted, subject to regulatory
approval, the exclusive right to import and market our generic
Seroquel XR®, Focalin XR®, Glucophage® XR, and
Keppra XR® in the Philippines. Under the terms of the
agreement, the distributor will be required to purchase a minimum
yearly quantity of all products included in the agreement and we
will be the exclusive supplier of said products. The
multi-year agreement with the Philippines distributor is subject to
early termination. Financial terms of the agreement have not been
disclosed. There can be no assurance as to when or if any of
our products or product candidates will receive regulatory approval
for sale in the Philippines or that, if so approved, any such
products will be successfully commercialized there and produce
significant revenues for us. Moreover, there can be no assurance
that we will not be required to conduct further studies for
Oxycodone ER, that the FDA will approve any of our requested
abuse-deterrent label claims or that the FDA will ultimately
approve the NDA for the sale of Oxycodone ER in the U.S. market, or
that it will ever be successfully commercialized.
In November 2018,
we announced that we had entered into two exclusive licensing and
distribution agreements with pharmaceutical distributors in
Malaysia and Vietnam.
A Malaysian
pharmaceutical distribution company was granted the exclusive
right, subject to regulatory approval, to import and market our
generic Seroquel XR® (quetiapine fumarate extended-release) in
Malaysia. Under the terms of the agreement, four strengths (50,
200, 300 and 400 mg) of generic Seroquel XR® will be
manufactured and supplied by us for distribution in Malaysia. We
are also in discussions to include other products in the agreement
with said distributor, who will be required to purchase a minimum
yearly quantity of all products included in the
agreement.
A Vietnamese
pharmaceutical distributor was granted the exclusive right, subject
to regulatory approval, to import and market our generic Seroquel
XR®, Glucophage® XR, and Keppra XR® in Vietnam.
Under the terms of the agreement, two strengths (500 and 750 mg) of
generic Glucophage® XR, three strengths (50, 150 and 200 mg)
of generic Seroquel XR® and one strength (500 mg) of generic
Keppra XR® will be manufactured and supplied by us for
distribution in Vietnam. The Vietnamese distributor will be
required to purchase a minimum yearly quantity of all products
included in the agreement.
The multi-year
agreements with the Malaysian and Vietnamese distributors are each
subject to early termination. Financial terms of the agreements
have not been disclosed. There can be no assurance as to when or if
any of our products will receive regulatory approval for sale in
Malaysia or Vietnam or that, if so approved, the products will be
successfully commercialized there and produce significant revenues
for the Company.
Additionally, in
January 2018 we announced we had commenced a research and
development program of pharmaceutical cannabidiol, or CBD, based
products. As part of this research and development program, we
filed multiple provisional patent applications with the United
States Patent and Trademark Office pertaining to the delivery and
application of cannabinoid-based therapeutics, began talks with
potential commercialization partners in the cannabidiol industry,
and identified a potential supplier of CBD. The patent filings,
together with certain of our already issued drug delivery patents,
are intended to form the basis of the development of a pipeline of
novel controlled-release product candidates with CBD as the main
active ingredient.
SELECTED
FINANCIAL INFORMATION
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
Revenue
|
1,712,731
|
5,504,452
|
2,247,002
|
Cost
of goods sold
|
124,870
|
704,006
|
-
|
Expenses
|
14,914,127
|
13,066,228
|
12,098,078
|
Loss
from operations
|
(13,326,266)
|
(8,265,782)
|
(9,851,076)
|
Net
loss per common share, basic and diluted
|
(2.89)
|
(2.86)
|
(3.80)
|
|
|
|
|
Cash
|
6,641,877
|
1,897,061
|
4,144,424
|
Total
assets
|
11,474,227
|
7,396,781
|
7,974,689
|
|
|
|
|
Convertible
debentures
|
1,790,358
|
1,290,465
|
1,494,764
|
Total
liabilities
|
7,371,920
|
7,010,398
|
6,858,425
|
Shareholders'
equity
|
4,102,307
|
386,383
|
1,116,264
|
Total
liabilities and shareholders equity
|
11,474,227
|
7,396,781
|
7,974,689
|
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
We have identified
the following accounting policies that we believe require
application of management’s most significant judgments, often
requiring the need to make estimates about the effect of matters
that are inherently uncertain and may change in subsequent
periods.
Disclosure
regarding our ability to continue as a going concern is included in
Note 1 to our audited consolidated financial statements for the
year ended November 30, 2018.
Use
of Estimates
The preparation of
the audited consolidated financial statements in conformity with
U.S. GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenue and
expenses during the year. Actual results could differ from those
estimates.
Areas where
significant judgment is involved in making estimates are: the
determination of the functional currency; the fair values of
financial assets and liabilities; the determination of units of
accounting for revenue recognition; the accrual of licensing and
milestone revenue; and forecasting future cash flows for assessing
the going concern assumption.
Revenue
recognition
The Company
accounts for revenue in accordance with the provisions of ASC topic
605 Revenue Recognition. The Company earns revenue from
non-refundable upfront fees, milestone payments upon achievement of
specified research or development, exclusivity milestone payments
and licensing payments on sales of resulting products. Revenue is
realized or realizable and earned when persuasive evidence of an
arrangement exists, delivery has occurred or services have been
rendered, the price to the customer is fixed or determinable, and
collectability is reasonably assured. From time to time, the
Company enters into transactions that represent multiple-element
arrangements. Management evaluates arrangements with multiple
deliverables to determine whether the deliverables represent one or
more units of accounting for the purpose of revenue
recognition.
A delivered item is
considered a separate unit of accounting if the delivered item has
stand-alone value to the customer, the fair value of any
undelivered items can be reliably determined, and the delivery of
undelivered items is probable and substantially in the Company's
control.
The relevant
revenue recognition accounting policy is applied to each separate
unit of accounting.
Licensing
The Company
recognizes revenue from the licensing of the Company's drug
delivery technologies, products and product candidates. Licensing
revenue is recognized as earned in accordance with the contract
terms when the amounts can be reasonably estimated and
collectability is reasonably assured.
The Company has a
license and commercialization agreement with Par. Under the
exclusive territorial license rights granted to Par, the agreement
requires that Par manufacture, promote, market, sell and distribute
the product. Licensing revenue amounts receivable by the Company
under this agreement are calculated and reported to the Company by
Par, with such amounts generally based upon net product sales and
net profit which include estimates for chargebacks, rebates,
product returns, and other adjustments. Licensing revenue payments
received by the Company from Par under this agreement are not
subject to further deductions for chargebacks, rebates, product
returns, and other pricing adjustments. Based on this arrangement
and the guidance per ASC topic 605, the Company records licensing
revenue as earned in the audited consolidated statements of
operations and comprehensive loss.
The Company also
has a license and commercial supply agreement with Mallinckrodt
which provides Mallinckrodt an exclusive license to market sell and
distribute in the U.S. three drug product candidates for which the
Company has ANDAs filed with the FDA, one of which (the
Company’s generic Seroquel XR®) received final approval
from the FDA in 2017. Under the terms of this agreement, the
Company is responsible for the manufacture of approved products for
subsequent sale by Mallinckrodt in the U.S. market. Following
receipt of final FDA approval for its generic Seroquel XR®,
the Company began shipment of manufactured product to Mallinckrodt.
Licensing revenue in respect of manufactured product is reported as
revenue in accordance with ASC topic 605. Once product is sold by
Mallinckrodt, the Company receives downstream licensing revenue
amounts calculated and reported by Mallinckrodt, with such amounts
generally based upon net product sales and net profit which
includes estimates for chargebacks, rebates, product returns, and
other adjustments. Such downstream licensing revenue payments
received by the Company under this agreement are not subject to
further deductions for chargebacks, rebates, product returns, and
other pricing adjustments. Based on this agreement and the guidance
per ASC topic 605, the Company records licensing revenue as earned
in the audited consolidated statements of operations and
comprehensive loss.
Milestones
The milestone
method recognizes revenue on substantive milestone payments in the
period the milestone is achieved. Milestones are considered
substantive if all of the following conditions are met: (i) the
milestone is commensurate with either the vendor’s
performance to achieve the milestone or the enhancement of the
value of the delivered item or items as a result of a specific
outcome resulting from the vendor’s performance to achieve
the milestone; (ii) the milestone relates solely to past
performance; and (iii) the milestone is reasonable relative to all
of the deliverables and payment terms within the arrangement.
Non-substantive milestone payments that might be paid to the
Company based on the passage of time or as a result of a
partner’s performance are allocated to the units of
accounting within the arrangement; they are recognized as revenue
in a manner similar to those units of accounting.
Research and development
Under arrangements
where the license fees and R&D activities can be accounted for
as a separate unit of accounting, non-refundable upfront license
fees are deferred and recognized as revenue on a straight-line
basis over the expected term of the Company's continued involvement
in the R&D process.
Deferred revenue
Deferred revenue
represents the funds received from clients, for which the revenues
have not yet been earned, as the milestones have not been achieved,
or in the case of upfront fees for drug development, where the work
remains to be completed. During the year ended November 30, 2016,
the Company received an up-front payment of $3,000,000 from
Mallinckrodt pursuant to the Mallinckrodt license and commercial
supply agreement, and initially recorded it as deferred revenue, as
it did not meet the criteria for recognition. For the year ended
November 30, 2018, the Company recognized $300,000 (2017 -
$300,000) of revenue based on a straight-line basis over the
expected term of the Mallinckrodt agreement of 10 years. In 2015,
the Company received an up-front payment of $150,000 from Teva
Pharmaceuticals USA, Inc. which the Company recognized as revenue
during the year ended November 30, 2017. As of November 30, 2018,
the Company has recorded a deferred revenue balance of $2,362,500
(November 30, 2017 - $2,662,500) relating to the underlying
contracts, of which $300,000 (November 30, 2017 - $300,000) is
considered a current portion of deferred revenue.
Research
and development costs
Research and
development costs related to continued R&D programs are
expensed as incurred in accordance with ASC topic 730. However,
materials and equipment are capitalized and amortized over their
useful lives if they have alternative future uses.
Inventory
Inventories
comprise raw materials, work in process, and finished goods, which
are valued at the lower of cost or market, on a first-in, first-out
basis. Cost for work in process and finished goods inventories
includes materials, direct labor, and an allocation of
manufacturing overhead. Market for raw materials is replacement
cost, and for work in process and finished goods is net realizable
value. The Company evaluates the carrying value of inventories on a
regular basis, taking into account such factors as historical and
anticipated future sales compared with quantities on hand, the
price the Company expects to obtain for products in their
respective markets compared with historical cost and the remaining
shelf life of goods on hand. As of November 30, 2018, the Company
had raw materials inventories of $144,659 (2017 - $115,667), work
in process of $73,927 (2017 - $Nil) and finished goods inventory of
$33,065 (2017 - $Nil) relating to the Company’s generic
Seroquel XR® product. The recoverability of the cost of any
pre-launch inventories with a limited shelf life is evaluated based
on the specific facts and circumstances surrounding the timing of
the anticipated product launch.
Translation
of foreign currencies
Transactions
denominated in currencies other than the Company and its wholly
owned operating subsidiaries’ functional currencies, the
monetary assets and liabilities are translated at the period end
rates. Revenue and expenses are translated at rates of exchange
prevailing on the transaction dates. All of the exchange gains or
losses resulting from these other transactions are recognized in
the audited consolidated statements of operations and comprehensive
loss.
The Company’s
functional and reporting currency is the U.S. dollar.
Convertible
debentures
In fiscal 2013, the
Company issued an unsecured convertible debenture in the principal
amount of $1.5 million (the “2013 Debenture”). At
issuance, the conversion option was bifurcated from its host
contract and the fair value of the conversion option was
characterized as an embedded derivative upon issuance as it met the
criteria of ASC topic 815 Derivatives and Hedging. Subsequent
changes in the fair value of the embedded derivative were recorded
in the consolidated statements of operations and comprehensive
loss. The proceeds received from the 2013 Debenture less the
initial amount allocated to the embedded derivative were allocated
to the liability and were accreted over the life of the 2013
Debenture using the imputed rate of interest. The Company changed
its functional currency effective December 1, 2013 such that the
conversion option no longer met the criteria for bifurcation and
was prospectively reclassified to shareholders’ equity under
ASC Topic 815 at the U.S. dollar translated amount at December 1,
2013.
On September 10,
2018, the Company completed a private placement financing of an
unsecured convertible debenture in the principal amount of $0.5
million (the “2018 Debenture”). At issuance, the
conversion price was lower than the market share price, and the
value of the beneficial conversion feature related to the 2018
Debenture was allocated to shareholders’ equity.
Investment
tax credits
The investment tax
credits (“ITC") receivable are amounts considered recoverable
from the Canadian federal and provincial governments under the
Scientific Research & Experimental Development
(“SR&ED”) incentive program. The amounts claimed
under the program represent the amounts based on management
estimates of eligible research and development costs incurred
during the year. Realization is subject to government approval. Any
adjustment to the amounts claimed will be recognized in the year in
which the adjustment occurs. Refundable ITCs claimed relating to
capital expenditures are credited to property and equipment.
Refundable ITCs claimed relating to current expenditures are netted
against research and development expenditures.
Recently
adopted accounting pronouncements
In August 2016,
the Financial Accounting Standards Board ("FASB")
issued Accounting Standards Update (“ASU”) No.
2016-15, Statement of Cash Flows (Topic 230) Classification of
Certain Cash Receipts and Cash Payments, which makes eight targeted
changes to how cash receipts and cash payments are presented and
classified in the Statement of Cash Flows. ASU 2016-15 became
effective on May 1, 2018. The Company adopted ASU 2016-15 and the
amendments did not have any material impact on the Company’s
financial position, results of operations, cash flows or
disclosures.
Future
accounting pronouncements
In May 2014, the
FASB issued ASU No. 2014-09 (“Topic 606”), Revenue from
Contracts with Customers, requiring an entity to recognize the
amount of revenue to which it expects to be entitled for the
transfer of promised goods or services to customers. The updated
standard will replace most existing revenue recognition guidance in
U.S. GAAP when it becomes effective. In March 2016, the FASB issued
ASU No. 2016-08 to clarify the implementation guidance on
considerations of whether an entity is a principal or an agent,
impacting whether an entity reports revenue on a gross or net
basis. In April 2016, the FASB issued ASU No. 2016-10 to clarify
guidance on identifying performance obligations and the
implementation guidance on licensing. In May 2016, the FASB issued
amendments ASU No. 2016-11 and 2016-12 to amend certain aspects of
the new revenue guidance (including transition, collectability,
noncash consideration and the presentation of sales and other
similar taxes) and provided certain practical expedients. The
guidance is effective for annual reporting periods beginning after
December 15, 2017 (including interim reporting periods). Early
adoption is permitted but not before the annual reporting period
(and interim reporting period) beginning January 1, 2017. Entities
have the option of using either a full retrospective or a modified
approach to adopt the guidance. The Company anticipates that the
adoption of Topic 606 will not have a material impact on the
Company’s financial position, results of operations, and cash
flows.
In January 2016,
the FASB issued ASU No. 2016-01, which makes limited amendments to
the guidance in U.S. GAAP on the classification and measurement of
financial instruments. The new standard significantly revises an
entity’s accounting related to (1) the classification and
measurement of investments in equity securities and (2) the
presentation of certain fair value changes for financial
liabilities measured at fair value. It also amends certain
disclosure requirements associated with the fair value of financial
instruments. ASU No. 2016-01 is effective for fiscal years
beginning after December 15, 2017, and interim periods within those
annual periods. The Company anticipates that the adoption of this
standard will not have a material impact on the Company’s
financial position, results of operations, and cash
flows.
In February 2016,
the FASB issued new guidance, ASU No. 2016-02, Leases (Topic 842).
The main difference between current U.S. GAAP and the new guidance
is the recognition of lease liabilities based on the present value
of remaining lease payments and corresponding lease assets for
operating leases under current U.S. GAAP with limited exception.
Additional qualitative and quantitative disclosures are also
required by the new guidance. Topic 842 is effective for annual
reporting periods (including interim reporting periods) beginning
after December 15, 2018. Early adoption is permitted. The Company
is in the process of evaluating the amendments to determine if they
have a material impact on the Company’s financial position,
results of operations, cash flows or disclosures.
In August 2016, the
FASB issued ASU 2017-01 that changes the definition of a business
to assist entities with evaluating when a set of transferred assets
and activities is a business. The guidance requires an entity to
evaluate if substantially all of the fair value of the gross assets
acquired is concentrated in a single identifiable asset or a group
of similar identifiable assets; if so, the set of transferred
assets and activities is not a business. ASU 2017-01 also requires
a business to include at least one substantive process and narrows
the definition of outputs by more closely aligning it with how
outputs are described in ASC 606.1. ASU 2017-01 is effective for
public business entities for fiscal years beginning after December
15, 2017, and interim periods within those years. Early adoption is
permitted. The Company does not expect the adoption of the
amendments to have a material impact on the Company’s
financial position, results of operations, cash flows or
disclosures.
In May 2017, the
FASB issued ASU 2017-09 in relation to Compensation —Stock
Compensation (Topic 718), Modification Accounting. The amendments
provide guidance on changes to the terms or conditions of a
share-based payment award, which require an entity to apply
modification accounting in Topic 718. The amendments are effective
for all entities for annual periods, and interim periods within
those annual periods, beginning after December 15, 2017. Early
adoption is permitted, including adoption in any interim period,
for (1) public business entities for reporting periods for which
financial statements have not yet been issued and (2) all other
entities for reporting periods for which financial statements have
not yet been made available for issuance. The amendments should be
applied prospectively to an award modified on or after the adoption
date. The Company does not expect the adoption of the amendments to
have a material impact on the Company’s financial position,
results of operations, cash flows or disclosures.
RESULTS
OF OPERATIONS
Our results of
operations have fluctuated significantly from period to period in
the past and are likely to do so in the future. We anticipate that
our quarterly and annual results of operations will be impacted for
the foreseeable future by several factors, including the timing of
approvals to market our product candidates in various jurisdictions
and any resulting licensing revenue, milestone revenue, product
sales, the number of competitive products and the extent of any
aggressive pricing activity, wholesaler buying patterns, the timing
and amount of payments received pursuant to our current and future
collaborations with third parties, the existence of any
first-to-file exclusivity periods, and the progress and timing of
expenditures related to our research, development and
commercialization efforts. Due to these fluctuations, we presently
believe that the period-to-period comparisons of our operating
results are not a reliable indication of our future
performance.
|
For
the years ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Licensing
|
1,370,607
|
5,025,350
|
2,209,502
|
(3,654,743)
|
-73%
|
2,815,848
|
127%
|
Up-front
fees
|
342,124
|
479,102
|
37,500
|
(136,978)
|
-29%
|
441,602
|
1178%
|
|
1,712,731
|
5,504,452
|
2,247,002
|
(3,791,721)
|
-69%
|
3,257,450
|
145%
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
124,870
|
704,006
|
-
|
(579,136)
|
-82%
|
704,006
|
N/A
|
Gross
Margin
|
1,587,861
|
4,800,446
|
2,247,002
|
(3,212,585)
|
-67%
|
2,553,444
|
114%
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
Research
and development
|
10,827,293
|
9,271,353
|
8,166,736
|
1,555,940
|
17%
|
1,104,617
|
14%
|
Selling,
general and administrative
|
3,476,450
|
3,287,914
|
3,546,132
|
188,536
|
6%
|
(258,218)
|
-7%
|
Depreciation
|
610,384
|
506,961
|
385,210
|
103,423
|
20%
|
121,751
|
32%
|
|
14,914,127
|
13,066,228
|
12,098,078
|
1,847,899
|
14%
|
968,150
|
8%
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(13,326,266)
|
(8,265,782)
|
(9,851,076)
|
(5,060,484)
|
61%
|
1,585,294
|
-16%
|
|
|
|
|
|
|
|
|
Net foreign exchange
(loss) gain
|
8,592
|
(80,093)
|
(22,470)
|
88,685
|
-111%
|
(57,623)
|
256%
|
Interest
income
|
227
|
15,037
|
207
|
(14,810)
|
-98%
|
14,830
|
7164%
|
Interest
expense
|
(255,231)
|
(389,239)
|
(270,238)
|
134,008
|
-34%
|
(119,001)
|
44%
|
Financing
cost
|
(174,802)
|
(137,363)
|
-
|
(37,439)
|
27%
|
(137,363)
|
N/A
|
Net loss and
comprehensive loss
|
(13,747,480)
|
(8,857,440)
|
(10,143,577)
|
(4,890,040)
|
55%
|
1,286,137
|
-13%
|
Year Ended November 30, 2018 Compared to the Year Ended November
30, 2017
Revenue
The Company
recorded revenues of $1,712,731 for the year ended November 30,
2018 versus $5,504,452 for the year ended November 30, 2017. Such
revenues consisted primarily of licensing revenues from commercial
sales of the 15, 25, 30 and 35 mg strengths of our generic Focalin
XR® under the Par agreement. The decrease in revenues in the
year ended November 30, 2018 compared to year ended November 30,
2017 is primarily due to considerably lower profit share payments
from sales of generic Focalin XR® capsules in the U.S.
Beginning in early 2018, we began to see significant impact from
aggressive pricing by competitors, resulting in a marked increase
in gross-to-net deductions such as wholesaler rebates, chargebacks
and pricing adjustments. While the gross-to-net deductions
fluctuate on a quarter over quarter basis, profit share payments
for the last several quarters have shown decline over the same
period in the prior year.
Revenues from
generic Seroquel XR® are still well below levels expected at
the launch of the product in 2017, primarily due to the
Company’s commercial partner entering the market later than
planned. Several initiatives to gain market share have shown some
improved returns, however, it is expected to take some time to
determine if the product can achieve meaningful market penetration.
Management is continuing to evaluate strategic options to improve
returns from this product.
Cost of goods sold
The Company
recorded cost of goods sold of $124,870 for the year ended November
30, 2018 versus $704,006 for the year ended November 30, 2017. Cost
of sales reflects the Company’s manufacturing shipments of
generic Seroquel XR® to Mallinckrodt.
Research and Development
Expenditures for
R&D for the year ended November 30, 2018 were higher by
$1,555,940 compared to the year ended November 30, 2017. The
increase is primarily due to higher third party consulting fees and
higher patent litigation expenses.
In the year ended
November 30, 2018, we recorded $883,064 of expenses for stock-based
compensation for R&D employees compared to $1,654,051 for the
year ended November 30, 2017, of which $793,795 was for expenses
related to performance-based stock options which vested on FDA
approval for venlafaxine hydrochloride extended-release capsules in
November 2018, and for the year ended November 30, 2017, $1,577,772
was for expenses related to performance-based stock options which
vested on FDA approval for metformin hydrochloride extended release
tablets in February 2017 and FDA approval of our quetiapine
fumarate extended release tablets in May 2017.
After adjusting for
the stock-based compensation expenses discussed above, expenditures
for R&D for the year ended November 30, 2018 were higher by
$2,326,927 compared to the year ended November 30, 2017. The
increase was primarily due to an increase in third party R&D
expenditures as a result of clinical trials for Oxycodone ER and
higher patent litigation expenses.
Selling, General and Administrative
Selling, general
and administrative expenses were $3,476,450 for the year ended
November 30, 2018 in comparison to $3,287,914 for the year ended
November 30, 2017, an increase of $188,536. The increase is due to
higher expenses related to administrative costs, partially offset
by a decrease in wages and marketing cost.
Administrative
costs for the year ended November 30, 2018 were $1,793,724 in
comparison to $1,402,253 in the year ended November 30, 2017. The
increase for the year ended November 30, 2018 was due to the
increase in professional fees and legal fees.
Expenditures for
wages and benefits for the year ended November 30, 2018 were
$1,124,568 in comparison to $1,240,361 in the year ended November
30, 2017. For the year ended November 30, 2018, we recorded $44,622
as expense for stock-based compensation compared to an expense of
$95,948 for the year ended November 30, 2017. After adjusting for
the stock-based compensation expenses, expenditures for wages for
the year ended November 30, 2018 were lower by $64,467 compared to
the year ended November 30, 2017.
Marketing costs for
the year ended November 30, 2018 were $421,401 in comparison to
$502,688 in the year ended November 30, 2017. This decrease is
primarily the result of a decrease in travel expenditures related
to business development and investor relations
activities.
Occupancy costs for
the year ended November 30, 2018 were $136,757 in comparison to
$142,612 for the year ended November 30, 2017. The slight decrease
is due to lower facility operating expenses.
Depreciation
Depreciation
expenses for the year ended November 30, 2018 were $610,384 in
comparison to $506,961 in the year ended November 30, 2017. The
increase is primarily due to the additional investment in
production, laboratory and computer equipment during the year ended
November 30, 2018.
Foreign Exchange Gain
Foreign exchange
gain was $8,592 for the year ended November 30, 2018 in comparison
to a loss of $80,093 in the year ended November 30, 2017. The
foreign exchange gain for the year ended November 30, 2018 was due
to the strengthening of the U.S. dollar against the Canadian dollar
during the year ended November 30, 2018 as the exchange rates
changed to $1.00 for C$1.3301 as at November 30, 2018 from $1.00
for C$1.2888 as at November 30, 2017. The foreign exchange loss for
the year ended November 30, 2017 was due to the weakening of the
U.S. dollar against the Canadian dollar during the year ended
November 30, 2017 as the exchange rates changed to $1.00 for
C$1.2888 as at November 30, 2017 from $1.00 for C$1.3429 as at
November 30, 2016.
Interest Income
Interest income for
the year ended November 30, 2018 was lower by $14,810 in comparison
to the prior period. For the year ended November 30, 2018 interest
was lower largely due to interest received on input tax credit
refunds under the SR&ED incentive program in the third quarter
of 2017.
Interest Expense
Interest expense
for the year ended November 30, 2018 was lower by $134,008 compared
with the prior year. This is primarily due to interest expense paid
on the 2013 Debenture, which accrues interest payable at 12%
annually, as well as the 2018 Debenture, which accrues interest
payable at 10% annually, and the related conversion option embedded
derivative accreted at an annual effective interest of
approximately 4.9% during the 2018 fiscal year in comparison to the
fiscal year 2017 when the 2013 Debenture effective interest was
approximately 15.2%.
Net Loss
The Company
recorded net loss for the year ended November 30, 2018 of
$13,747,480 or $2.89 per common share, compared with a net loss of
$8,857,440 or $2.86 per common share for the year ended November
30, 2017. In the year ended November 30, 2018, the higher net loss
is attributed to the lower licensing revenues from commercial sales
of generic Focalin XR® and lower licensing revenues from
Quetiapine ER our generic Seroquel XR® (quetiapine
fumarate extended-release) combined with increased third party
R&D expenses primarily related to clinical trials for the
Company’s Oxycodone ER product, legal and other
administrative expenses. In the year ended November 30, 2017, the
net loss was attributed to the ongoing R&D and selling, general
and administrative expenses, partially offset by licensing revenues
from commercial sales of generic Focalin XR® and, to a lesser
extent, sales of generic Seroquel XR® shipped to
Mallinckrodt.
Year Ended November 30, 2017 Compared to the Year Ended November
30, 2016
Revenue
The Company
recorded revenues of $5,504,452 for the year ended November 30,
2017 versus $2,247,002 for the year ended November 30, 2016.
Revenues consisted primarily of licensing revenues from commercial
sales of the 10, 15, 20, 25, 30 and 35 mg of generic Focalin
XR® under the Par agreement. The increase in revenues for the
year ended November 30, 2017 was primarily due to the launch in
January 2017 of the 25 and 35 mg strengths of generic Focalin
XR® capsules in the U.S and also reflects revenue from the
Company’s generic Seroquel XR® launched by Mallinckrodt
in June 2017. The Company’s revenues on the 25 and 35 mg
strengths of generic Focalin XR® showed some decline
commencing July 2017 when their 6 month exclusivity expired, but
have since levelled off. The 15 and 30 mg strengths continue to
perform well, with the 10 and 20 mg strengths contributing less due
to their launch date being late August 2017. The 5 and 40 mg
strengths did not contribute at all to top line revenue in fiscal
2017 as the products were not in the market until after year end.
Revenues from generic Seroquel XR® were considerably lower
than originally anticipated, primarily due to timing of the product
launch, which was several weeks after other generics entered the
market. As such, it is expected to take some time to gain market
share as wholesaler contracts come up for renewal. Revenues under
the Par and Mallinckrodt agreements represent the commercial sales
of the generic products in those strengths and may not be
representative of future sales.
Cost of goods sold
The Company
recorded cost of goods sold of $704,006 for the year ended November
30, 2017 versus $Nil for the year ended November 30, 2016. Cost of
sales for the year ended November 30, 2017, reflects the
Company’s shipments of generic Seroquel XR® to
Mallinckrodt which are manufactured by the Company and supplied to
Mallinckrodt on a cost-plus basis. This product was not marketed or
sold prior to fiscal 2017.
Research and Development
Expenditures for
R&D for the year ended November 30, 2017 were higher by
$1,104,617 compared to the year ended November 30, 2016. The
increase is primarily due to higher stock option compensation
expense as a result of certain performance based stock options
vesting upon FDA approval of quetiapine fumarate extended release
tablets in the 50, 150, 200, 300 and 400 mg strengths, as detailed
below. R&D expenses are also higher due to higher third party
consulting fees associated with our preparation for the FDA
Advisory Committees meeting in relation to our Oxycodone ER NDA
filing. The R&D expenses for the year ended November 30, 2016
were revised higher by $1,177,782 as a result of our shareholders
approving an extension of the expiry date of certain performance
based stock options.
In the year ended
November 30, 2017, we recorded $1,654,051 of expenses for
stock-based compensation for R&D employees, of which $1,577,772
was for expenses related to performance based stock options which
vested on FDA approval for metformin hydrochloride extended release
tablets in February 2017 and FDA approval of our quetiapine
fumarate extended release tablets in May 2017. In the year ended
November 30, 2016, we recorded $1,995,805 as expense for stock
based compensation for R&D employees, of which $620,632 was for
expenses related to performance based stock options which vested on
FDA approval of our generic Keppra XR® in February
2016.
After adjusting for
the stock-based compensation expenses discussed above, expenditures
for R&D for the year ended November 30, 2017 were higher by
$1,446,371 compared to the year ended November 30, 2016. The
increase was primarily due to costs related to preparing for the
FDA Advisory Committee meeting, an increase in third party R&D
expenditures and higher compensation expense.
Selling, General and Administrative
Selling, general
and administrative expenses were $3,287,914 for the year ended
November 30, 2017 in comparison to $3,546,132 for the year ended
November 30, 2016, a decrease of $258,218. The decrease is due to
lower wages and benefits and administrative costs offset by higher
expenses related to marketing cost and occupancy cost discussed in
greater detail below.
Expenditures for
wages and benefits for the year ended November 30, 2017 were
$1,240,361 in comparison to $1,454,501 in the year ended November
30, 2016. For the year ended November 30, 2017, we recorded $95,948
as expense for stock-based compensation compared to an expense of
$265,639 for the year ended November 30, 2016. After adjusting for
the stock-based compensation expenses, expenditures for wages for
the year ended November 30, 2017 were lower by $44,449 compared to
the year ended November 30, 2016. The decrease is attributable to
the accrual of bonuses to certain management employees in the year
ended November 30, 2016, there were no bonuses paid in the year
ended November 30, 2017.
Administrative
costs for the year ended November 30, 2017 were $1,402,253 in
comparison to $1,558,633 in the year ended November 30, 2016. The
decrease relates primarily to lower professional fees.
Marketing costs for
the year ended November 30, 2017 were $502,688 in comparison to
$413,646 in the year ended November 30, 2016. The increase is
primarily the result of an increase in travel expenditures related
to business development and investor relations
activities.
Occupancy costs for
the year ended November 30, 2017 were $142,612 in comparison to
$119,352 for the year ended November 30, 2016. The increase is due
to the incremental cost of leasing an adjoining facility in order
to meet the Company’s anticipated growth
requirements.
Depreciation
Depreciation
expenses for the year ended November 30, 2017 were $506,961 in
comparison to $385,210 in the year ended November 30, 2016. The
increase is primarily due to the additional investment in
production, laboratory and computer equipment during the year ended
November 30, 2017.
Foreign Exchange Loss
Foreign exchange
loss was $80,093 for the year ended November 30, 2017 in comparison
to a loss of $22,470 in the year ended November 30, 2016. The
foreign exchange loss for the year ended November 30, 2017 was due
to the weakening of the Canadian dollar against the U.S. dollar
during the year ended November 30, 2017 as the exchange rates
changed to $1.00 for C$1.2888 as at November 30, 2017 from $1.00
for C$1.3429 as at November 30, 2016. The foreign exchange loss for
the year ended November 30, 2016 was due to the weakening of the
Canadian dollar against the U.S. dollar during the year ended
November 30, 2016 as the exchange rates changed to $1.00 for
C$1.3429 as at November 30, 2016 from $1.00 for C$1.3353 as at
November 30, 2015.
Interest Income
Interest income for
the year ended November 30, 2017 was higher by $14,830 in
comparison to the prior period. For the year ended November 30,
2017 interest was higher largely due to interest received on input
tax credit refunds under the SR&ED program.
Interest Expense
Interest expense
for the year ended November 30, 2017 was higher by $119,001
compared with the prior period. This is due to interest expense
paid in 2017 on the 2013 Debenture which accrues interest payable
at 12% annually and the related conversion option embedded
derivative accreted at an annual effective interest of
approximately 15.2%, in comparison to the fiscal year 2016 when the
2013 Debenture effective interest was approximately
4.2%.
Net Loss
The Company
recorded net loss for the year ended November 30, 2017 of
$8,857,440 or $2.86 per common share, compared with a net loss of
$10,143,577 or $3.80 per common share for the year ended November
30, 2016. In the year ended November 30, 2017, the net loss was
attributed to the ongoing R&D and selling, general and
administrative expenses, partially offset by licensing revenues
from commercial sales of generic Focalin XR® and to a lesser
extent, sales of generic Seroquel XR® shipped to Mallinckrodt.
The net loss in 2017 is lower compared to 2016 due to higher
licensing revenues which were partially offset by an increase in
performance based stock option expense and higher third party
R&D expenditures. Revenue from commercial sales of generic
Focalin XR® and generic Seroquel XR® in the year ended
November 30, 2017, was $4,269,691 versus $2,209,502 in fiscal 2016.
This is primarily due to the launch of additional strengths of
generic Focalin XR® in 2017 as well as the launch of generic
Seroquel XR®, In the year ended November 30, 2016, the higher
net loss was primarily attributed to lower licensing revenues from
commercial sales of generic Focalin XR® for 2016. To a lesser
extent, the higher loss for the 2016 period was due to the accrual
of management bonuses and additional compensation costs related to
vested performance options as a result of the FDA approval of
generic Keppra XR® and the Company’s shareholders
approving an extension of the expiry date of the performance based
stock options.
SUMMARY
OF QUARTERLY RESULTS
The table below
outlines selected financial data for the eight most recent
quarters. The quarterly results are unaudited and have been
prepared in accordance with U.S. GAAP, for interim financial
information.
Quarter Ended
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
November
30, 2018
|
387,691
|
(3,784,512)
|
(0.67)
|
(0.67)
|
August
31, 2018
|
413,555
|
(3,954,104)
|
(0.91)
|
(0.91)
|
May
31, 2018
|
576,967
|
(2,859,276)
|
(0.68)
|
(0.68)
|
February
28, 2018
|
334,518
|
(3,149,588)
|
(0.91)
|
(0.91)
|
November
30, 2017
|
1,077,835
|
(2,510,936)
|
(0.76)
|
(0.76)
|
August
31, 2017
|
1,189,739
|
(2,550,314)
|
(0.83)
|
(0.83)
|
May
31, 2017
|
2,001,512
|
(1,805,329)
|
(0.59)
|
(0.59)
|
February
28, 2017
|
1,235,366
|
(1,990,861)
|
(0.66)
|
(0.66)
|
(i)
Quarterly per share amounts may not sum due to
rounding
It is important to
note that historical patterns of revenue and expenditures cannot be
taken as an indication of future revenue and expenditures. Net loss
has been somewhat variable over the last eight quarters and is
reflective of varying levels of commercial sales of generic Focalin
XR® capsules, the level of our R&D spending, and the
vesting or modification of performance based stock options. The
lower net loss in the fourth quarter of 2018 is primarily
attributed to lower R&D spending and selling, general and
administrative expenses offset by licensing revenues. The higher
net loss in the third quarter of 2018 is primarily attributed to
higher third party R&D expenses as a result of clinical trials
for Oxycodone ER, as well as increased patent litigation expenses.
The lower net loss in the second quarter of 2018 is primarily
attributed to slightly higher licensing revenues and lower R&D
spending. The net loss in the first quarter of 2018 is primarily
attributed to lower licensing revenues from commercial sales of
generic Focalin XR®, along with higher R&D expenses. The
lower net loss in the fourth quarter of 2017 is primarily
attributed to higher licensing revenues and lower R&D spending
and selling, general and administrative expenses. The net loss in
the third quarter of 2017 was primarily due to higher licensing
revenue, partially offset by higher expenses related to the FDA
Advisory Committees meeting in July 2017. The lower net loss in the
second quarter of 2017 was primarily attributed to higher than
normal licensing revenues from commercial sales of generic Focalin
XR® in the 25 and 35 mg strengths complementing the 15 and 30
mg strengths of our generic Focalin XR® marketed by
Par, partially offset by an increase in performance based options
expense and higher third party consulting fees. The lower net loss
in the first quarter of 2017 is primarily attributed to higher
licensing revenues from commercial sales of generic Focalin
XR® due to Par’s launch of the 25 and 35 mg strengths of
its generic Focalin XR® capsules in that quarter, partially
offset by an increase in performance based stock options expense
and legal and other professional fees. The higher net loss in the
fourth quarter of 2016 is attributable to the accrual of management
bonuses and additional compensation costs related to vested
performance based stock options as a result of the Company’s
shareholders approving an extension of the expiry date of the
performance based stock options.
LIQUIDITY
AND CAPITAL RESOURCES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows used in operating activities
|
(12,508,960)
|
(6,105,785)
|
(6,254,985)
|
(6,403,175)
|
105%
|
149,200
|
-2%
|
Cash
flows provided from financing activities
|
17,354,954
|
5,682,168
|
9,159,623
|
11,672,786
|
205%
|
(3,477,455)
|
-38%
|
Cash
flows used in investing activities
|
(101,178)
|
(1,823,746)
|
(515,410)
|
1,722,568
|
-94%
|
(1,308,336)
|
254%
|
Increase
(decrease) in cash
|
4,744,816
|
(2,247,363)
|
2,389,228
|
6,992,179
|
-311%
|
(4,636,591)
|
-194%
|
Cash,
beginning of year
|
1,897,061
|
4,144,424
|
1,755,196
|
(2,247,363)
|
-54%
|
2,389,228
|
136%
|
Cash,
end of year
|
6,641,877
|
1,897,061
|
4,144,424
|
4,744,816
|
250%
|
(2,247,363)
|
-54%
|
The Company had
cash of $6,641,877 as at November 30, 2018 compared to $1,897,061
as at November 30, 2017. The increase in cash was mainly due to the
cash receipts provided from financing activities derived from the
Company’s two registered direct offering in March 2018,
the 2018 Debenture financing in
September 2018 and an underwritten public offering in
October 2018, offset by ongoing
expenditures in R&D and selling, general and administrative
expenses. The decrease in cash during the year ended
November 30, 2017 was mainly a result of our ongoing expenditures
in R&D and selling, general, and administrative expenses, which
included increased consulting fees incurred to prepare for the July
26, 2017 FDA Advisory Committees meeting and an increase in
purchases of plant and production equipment to support our generic
Seroquel XR® launch, which were only partially offset by
higher cash receipts from commercialized sales of our generic
Focalin XR® and cash receipts provided from financing
activities derived from common share sales under the
Company’s at-the-market offering program and the
Company’s underwritten public offering in October 2017. The
increase in cash during the year ended November 30, 2016 was mainly
a result of an increase in cash flows provided from financing
activities which were mainly from the Company’s underwritten
public offering in June 2016 and common share sales under the
Company’s at-the-market offering program, the receipt of a
non-refundable upfront payment of $3,000,000 under the Mallinckrodt
agreement, partially offset by lower cash receipts relating to
commercialized sales of our generic Focalin XR® and a
reduction in accounts payable and accrued liabilities.
In November 2013,
the Company entered into an equity distribution agreement with Roth
Capital Partners, LLC (“Roth”), pursuant to which the
Company originally could from time to time sell up to 530,548 of
the Company’s common shares for up to an aggregate of $16.8
million (or such lesser amount as may then be permitted under
applicable exchange rules and securities laws and regulations)
through at-the-market issuances on Nasdaq or otherwise. Under the
equity distribution agreement, the Company was able at its
discretion, from time to time, offer and sell common shares through
Roth or directly to Roth for resale to the extent permitted under
Rule 415 under the Securities Act of 1933, as amended, at such time
and at such price as were acceptable to the Company, from time to
time, by means of ordinary brokers’ transactions on Nasdaq or
otherwise at market prices prevailing at the time of sale or as
determined by the Company. The Company has paid Roth a commission,
or allowed a discount, of 2.75% of the gross proceeds that the
Company received from any sales of common shares under the equity
distribution agreement. The Company also agreed to reimburse Roth
for certain expenses relating to the at-the-market offering
program. During the year ended November 30, 2018, an aggregate of
Nil (adjusted to reflect the reverse split: 2017 - 110,815; 2016
– 147,126) common shares were sold on Nasdaq for gross
proceeds of $Nil (2017- $2,541,640; 2016 - $3,469,449), with net
proceeds to the Company of $Nil (2017 - $2,468,474; 2016 -
$3,368,674), respectively, under the at-the-market offering
program. In March 2018, the Company terminated its continuous
offering under the prospectus supplement dated July 18, 2017 and
prospectus dated July 17, 2017 in respect of its at-the-market
program. The underwriting agreement relating to the October 2018
offering restricts the Company's ability to use this equity
distribution agreement. It contains a prohibition on the Company:
(i) for a period of two years following the date of the
underwriting agreement, from directly or indirectly in any
at-the-market or continuous equity transaction, offer to sell, or
otherwise dispose of shares of capital stock of the Company or any
securities convertible into or exercisable or exchangeable for its
shares of capital stock or (ii) for a period of five years
following the closing, effecting or entering into an agreement to
effect any issuance by the Company of common shares or common share
equivalents involving a certain variable rate transactions under an
at-the-market offering agreement, whereby the Company may issue
securities at a future determined price, except that, on or after
the date that is two years after the closing, the Company may enter
into an at-the-market offering agreement.
For the year ended
November 30, 2018, net cash flows used in operating activities
increased to $12,508,960 as compared to net cash flows used in
operating activities for the year ended November 30, 2017 of
$6,105,785. The increase was primarily a result of the higher loss
from operations, an increase in prepaid expenses, and accounts
payable, partially offset by a decrease in accounts receivable. For
the year ended November 30, 2017, net cash flows used in operating
activities decreased to $6,105,785 as compared to net cash flows
used in operating activities for the year ended November 30, 2016
of $6,254,985. The decrease was primarily due to a significant
reduction in accounts payable and accrued liabilities in fiscal
2016 as well as a reduction of inventory and accounts receivable
levels in fiscal 2017. The November 30, 2016 decrease was due to
lower cash receipts relating to commercial sales of our generic
Focalin XR® capsules by Par for the 15 and 30 mg strengths and
a reduction in accounts payable and accrued liabilities, partially
offset by the receipt of a non-refundable upfront payment of
$3,000,000 under the Mallinckrodt agreement.
R&D costs,
which are a significant portion of the cash flows used in operating
activities, related to continued internal R&D programs are
expensed as incurred. However, equipment and supplies are
capitalized and amortized over their useful lives if they have
alternative future uses. For the year ended November 30, 2018 and
the year ended November 30, 2017, R&D expense was $10,827,293,
and $9,271,353, respectively. The increase was primarily due to an
increase in third party R&D expenditures as a result of
clinical trials for Oxycodone ER and higher patent litigation
expenses. For the year ended November 30, 2017 and the year ended
November 30, 2016, R&D expense was $9,271,353, and $8,166,736,
respectively. The increase was mainly due to consulting fees
associated with our preparation for the FDA Advisory Committees
meeting in relation to our Oxycodone ER NDA filing and the increase
due to stock based compensation expenses of $1,577,772 related to
vested performance options during the year ended November 30,
2017.
For the year ended
November 30, 2018, net cash flows provided from financing
activities of $17,354,954 principally relate to two registered
direct offerings of an aggregate of 883,333 common shares at a
price of $6.00 per share (post reverse split) for gross proceeds of
$5,300,000 in March 2018, and the 2018
Debenture financing in the aggregate principal amount of $0.5
million in September 2018, and in October 2018, raised
$14,344,906 in gross proceeds as part of an underwritten public
offering. In October 2018, we completed an underwritten public
offering in the United States, resulting in the sale to the public
of 827,970 units at $0.75 per unit, which are comprised of one
common share and one warrant (the 2018 Unit Warrants) exercisable
at $0.75 per share. We concurrently sold an additional 1,947,261
common shares and 2018 Option Warrants to purchase 2,608,695 common
shares exercisable at $0.75 per share pursuant to the
over-allotment option exercised in part by the
underwriter. The price for the common shares issued in
connection with exercise of the overallotment option was $0.74 per
share and the price for the warrants issued in connection with the
exercise of the overallotment option was $0.01 per warrant, less in
each case the underwriting discount. In addition, we issued
16,563,335 2018 Pre-Funded Units, each 2018 Pre-Funded Unit
consisting of one 2018 Pre-Funded Warrant to purchase one common
share and one 2018 Warrant to purchase one common share. The 2018
Pre-Funded Units were offered to the public at $0.74 each, and a
2018 Pre-Funded Warrant is exercisable at $0.01 per share. Each
2018 Firm Warrant is exercisable immediately and has a term of five
years and each 2018 Pre-Funded Warrant is exercisable immediately
and until all 2018 Pre-Funded Warrants are exercised. We also
issued October 2018 Placement Agent Warrants to the placement
agents to purchase 1,160,314 common shares at an exercise price of
$0.9375 per share, which were exercisable immediately upon
issuance. In aggregate, the Company issued 2,775,231 common shares,
16,563,335 2018 Pre-Funded Warrants and 20,000,000 2018 Firm
Warrants in addition to 1,160,314 October 2018 Placement Agent
Warrants. During the year ended November 30, 2018, 12,153,334 2018
Pre-Funded Warrants were exercised for proceeds of
$121,553, partially offset by cost
related to the financing. For the year ended November 30,
2017, net cash flows provided from financing activities of
$5,682,168 principally related to the Company completing an
underwritten public offering in October 2017 of 363,636 common
shares, at a price of $11.00 per share and warrants to purchase an
aggregate of 181,181 common shares, for gross proceeds of
$4,000,000. The warrants became exercisable six months from
issuance, will expire 30 months after they become exercisable and
have an exercise price of $12.50 per common share. The Company also
issued to the placement agents warrants to purchase 18,181 shares
of common stock at an exercise price of $13.75 per share. The
total net proceeds from the offering were $3,499,508, after
deducting offering expenses, at-the-market issuances of common
shares, and the exercise of warrants, offset by payments on the
2013 Debenture.
For the year ended
November 30, 2018, net cash flows used in investing activities of
$101,178 related mainly to the purchase of production, laboratory
and computer equipment. For the year ended November 30, 2017, net
cash flows used in investing activities of $1,823,746 related
primarily to purchase of plant and production equipment required to
support our generic Seroquel XR® launch. For the year ended
November 30, 2016, net cash flows used in investing activities of
$515,410 related mainly to purchase of production, laboratory and
computer equipment.
All non-cash items
have been added back or deducted from the consolidated audited
statements of cash flows.
With the exception
of the quarter ended February 28, 2014, the Company has incurred
losses from operations since inception. To date, the Company has
funded its R&D activities principally through the issuance of
securities, loans from related parties, funds from the IPC
Arrangement Agreement and funds received under commercial license
agreements. Since November 2013, research has also been funded from
revenues from sales of our generic Focalin XR® capsules for
the 15 and 30 mg strengths. With the launch of the 25 and 35 mg
strengths by Par in January 2017, the launch of the 10 and 20 mg
strengths in May 2017 along with the launch of the 5 and 40 mg
strengths in November 2017, we expect sales of generic Focalin
XR®, due to continued competitive pressures, to be negatively
impacted for the next several quarters. As of November 30, 2018,
the Company had a cash balance of $6.6 million. As of February 22,
2019, our cash balance was $3.0 million. We currently expect to
satisfy our operating cash requirements until May 2019 from cash on
hand and quarterly profit share payments from Par and Mallinckrodt.
The Company will need to obtain additional funding as we further
the development of our product candidates. Potential sources of
capital may include payments from licensing agreements, cost
savings associated with managing operating expense levels, equity
and/or debt financings and/or new strategic partnership agreements
which fund some or all costs of product development. We intend to
utilize the equity markets to bridge any funding shortfall and to
provide capital to continue to advance our most promising product
candidates. Our future operations are highly dependent upon our
ability to source additional capital to support advancing our
product pipeline through continued R&D activities and to fund
any significant expansion of our operations. Our ultimate success
will depend on whether our product candidates receive the approval
of the FDA or Health Canada and whether we are able to successfully
market approved products. We cannot be certain that we will be able
to receive FDA or Health Canada approval for any of our current or
future product candidates, that we will reach the level of sales
and revenues necessary to achieve and sustain profitability, or
that we can secure other capital sources on terms or in amounts
sufficient to meet our needs or at all. Our cash requirements for
R&D during any period depend on the number and extent of the
R&D activities we focus on. At present, we are working
principally on our Oxycodone ER 505(b)(2), PODRASTM technology,
additional 505(b)(2) product candidates for development in various
indication areas and selected generic product candidate development
projects. Our development of Oxycodone ER will require significant
expenditures, including costs to defend against the Purdue
litigation. For our RegabatinTM
XR 505(b)(2) product candidate, Phase III clinical trials can be
capital intensive, and will only be undertaken consistent with the
availability of funds and a prudent cash management strategy. We
anticipate some investment in fixed assets and equipment over the
next several months, the extent of which will depend on cash
availability. In October 2018, we raised $14,344,906 in gross
proceeds as part of an underwritten public offering from the sale
of 827,970 Units at $0.75 per one common share and one warrant
exercisable at $0.75 per share. We concurrently sold an additional
1,947,261 common shares at $0.74 per share and 2,608,695 2018
Option Warrants exercisable at $0.75 per share pursuant to the
over-allotment option exercised in part by the underwriter. In
addition, we issued 16,563,335 2018 Pre-Funded Units, each 2018
Pre-Funded Unit consisted of one 2018 Pre-Funded Warrant to
purchase one common share and one 2018 Warrant to purchase one
common share. The 2018 Pre-Funded Units were offered at $0.74 each,
and the 2018 Pre-Funded Warrant is exercisable at $0.01 per share.
During the year ended November 30, 2018, 12,153,334 2018 Pre-Funded
Warrants were exercised for proceeds of $121,553.
On September 10,
2018, the Company completed a private placement financing of the
2018 Debenture in the principal amount of $0.5 million. The 2018
Debenture is due to mature on September 1, 2020. The 2018 Debenture
bears interest at a rate of 10% per annum, payable monthly, is
pre-payable at any time at the option of the Company and is
convertible at any time into common shares at a conversion price of
$3.00 per common share at the option of the holder. Drs. Isa
and Amina Odidi, who are directors, executive officers and
shareholders of our Company, provided us with the original $500,000
of the proceeds for the 2018 Debenture.
Effective October
1, 2018, the maturity date for the 2013 Debenture was extended to
April 1, 2019. In December 2018, a
principal repayment of $300,000 was made for the 2013 Debenture in
respect of the $1,500,000 loan. The Company currently
expects to repay the current outstanding principal amount of
$1,050,000 on or about April 1, 2019, if the Company then has cash
available.
The availability of
equity or debt financing will be affected by, among other things,
the results of our R&D, our ability to obtain regulatory
approvals, our success in commercializing approved products with
our commercial partners and the market acceptance of our products,
the state of the capital markets generally, strategic alliance
agreements, and other relevant commercial considerations. In
addition, if we raise additional funds by issuing equity
securities, our then existing security holders will likely
experience dilution, and the incurring of indebtedness would result
in increased debt service obligations and could require us to agree
to operating and financial covenants that would restrict our
operations. In the event that we do not obtain sufficient
additional capital, it will raise substantial doubt about our
ability to continue as a going concern, realize our assets and pay
our liabilities as they become due. Our cash outflows are expected
to consist primarily of internal and external R&D, legal and
consulting expenditures to advance our product pipeline and
selling, general and administrative expenses to support our
commercialization efforts. Depending upon the results of our
R&D programs, the impact of the litigation against us and the
availability of financial resources, we could decide to accelerate,
terminate, or reduce certain projects, or commence new ones. Any
failure on our part to successfully commercialize approved products
or raise additional funds on terms favorable to us or at all, may
require us to significantly change or curtail our current or
planned operations in order to conserve cash until such time, if
ever, that sufficient proceeds from operations are generated, and
could result in us not taking advantage of business opportunities,
in the termination or delay of clinical trials or us not taking any
necessary actions required by the FDA or Health Canada for one or
more of our product candidates, in curtailment of our product
development programs designed to identify new product candidates,
in the sale or assignment of rights to our technologies, products
or product candidates, and/or our inability to file ANDAs, ANDSs or
NDAs at all or in time to competitively market our products or
product candidates.
OUTSTANDING
SHARE INFORMATION
As at November 30,
2018 the Company had 18,252,243 common shares issued and
outstanding, which is an increase of 14,781,792 when compared to
November 30, 2017. The number of shares outstanding increased as a
result of the completion of the registered direct offerings of an
aggregate of 883,333 common shares in March 2018 and the completion
of the underwritten public offering in October 2018 for an
aggregate of 827,970 Units, comprised of one common share and one
2018 Unit Warrant, an additional 1,947,261 common shares and
2,608,695 2018 Option Warrants pursuant to the over-allotment
option exercised in part by the underwriter. In addition, we also
issued 2018 Pre-Funded Warrants exercisable for 16,563,335 common
shares, of which 12,153,334 2018 Pre-Funded Warrants were exercised
as of November 30, 2018. As at November 30, 2017, the Company had
3,470,451 common shares issued and outstanding, which was an
increase of 491,452 when compared to November 30, 2016. This
increase was principally a result of the completion of the
underwritten public offering of 363,636 common shares in October
2017 as well as exercises of existing warrants for 16,801 common
shares, the sale of 110,815 common shares under our at-the-market
offering program and exercises of options for 200 common shares. In
November 2013, we entered into an equity distribution agreement
with Roth , pursuant to which we originally could from time to time
sell up to 530,548 of our common shares for up to an aggregate of
$16.8 million (or such lesser amount as may then be permitted under
applicable exchange rules and securities laws and regulations)
through at-the-market issuances on the Nasdaq or
otherwise. During the year ended November 30, 2018, an
aggregate of Nil (2017 – 110,815; 2016 – 147,126)
common shares were sold on Nasdaq for gross proceeds of $Nil (2017-
$2,541,640; 2016 - $3,469,449), with net proceeds to the Company of
$Nil (2017 - $2,468,474; 2016 - $3,368,674), respectively, under
the at-the-market offering program. During the year ended November
30, 2018, Roth received aggregate compensation of $Nil (2017 -
$73,166; 2016 - $100,775), in connection with such sales. The
number of options outstanding as of November 30, 2018 is 555,651, a
decrease of 27,160 from November 30, 2017, due to the expiry of
1,627 options and forfeiture of 25,533 options during the year
ended November 30, 2018. The warrants outstanding as of November
30, 2018 represent 21,984,884 common shares issuable upon the
exercise of 22,123,623 outstanding warrants, which represents an
increase of 21,586,905 common shares (21,409,578 warrants) from
November 30, 2017, due to the issuance of 21,646,146 warrants to
purchase 21,646,146 common shares and the expiry of 236,174
warrants to purchase 59,043 common shares during the year ended
November 30, 2018. During the year ended November 30, 2018,
12,153,334 2018 Pre-Funded Warrants were exercised. The number
of deferred share units outstanding as of November 30, 2018 is
10,279, an increase of 866 from November 30, 2017. As of February
22, 2019, the number of shares outstanding is
21,925,577.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT LIQUIDITY AND MARKET
RISK
Liquidity risk is
the risk that the Company will encounter difficulty raising liquid
funds to meet its commitments as they fall due. In meeting its
liquidity requirements, the Company closely monitors its forecasted
cash requirements with expected cash drawdown.
We are exposed to
interest rate risk, which is affected by changes in the general
level of interest rates. Due to the fact that the
Company’s cash is deposited with major financial institutions
in an interest savings account, we do not believe that the results
of operations or cash flows would be affected to any significant
degree by a sudden change in market interest rates given their
relative short-term nature.
Trade accounts
receivable potentially subjects the Company to credit risk. The
Company provides an allowance for doubtful accounts equal to the
estimated losses expected to be incurred in the collection of
accounts receivable.
The following table
sets forth details of the aged accounts receivable that are not
overdue as well as an analysis of overdue amounts and the related
allowance for doubtful accounts:
|
|
|
|
|
|
Total
accounts receivable
|
305,912
|
756,468
|
Less
allowance for doubtful accounts
|
(66,849)
|
(66,849)
|
Total
accounts receivable, net
|
239,063
|
689,619
|
|
|
|
Not
past due
|
239,063
|
689,619
|
Past
due for more than 31 days
|
|
|
but
no more than 120 days
|
-
|
5,176
|
Past
due for more than 120 days
|
66,849
|
61,673
|
Total
accounts receivable, gross
|
305,912
|
756,468
|
Financial
instruments that potentially subject the Company to concentration
of credit risk consist principally of uncollateralized accounts
receivable. The Company’s maximum exposure to credit risk is
equal to the potential amount of financial assets. For the year
ended November 30, 2018 and 2017, two customers accounted for
substantially all the revenue and all the accounts receivable of
the Company.
The Company is also
exposed to credit risk at period end from the carrying value of its
cash. The Company manages this risk by maintaining bank accounts
with a Canadian Chartered Bank. The Company’s cash is not
subject to any external restrictions.
We are exposed to
changes in foreign exchange rates between the Canadian and United
States dollar which could affect the value of our cash. The Company
had no foreign currency hedges or other derivative financial
instruments as of November 30, 2018. The Company did not enter into
financial instruments for trading or speculative purposes and does
not currently utilize derivative financial
instruments.
The Company has
balances in Canadian dollars that give rise to exposure to foreign
exchange (“FX”) risk relating to the impact of
translating certain non-U.S. dollar balance sheet accounts as these
statements are presented in U.S. dollars. A strengthening U.S.
dollar will lead to a FX loss while a weakening U.S. dollar will
lead to a FX gain. For each Canadian dollar balance of $1.0
million, a +/- 10% movement in the Canadian currency held by the
Company versus the U.S. dollar would affect the Company’s
loss and other comprehensive loss by $0.1 million.
Balances
denominated in foreign currencies that are considered financial
instruments are as follows:
|
November
30, 2018
|
November
30, 2017
|
|
|
|
|
|
FX
rates used to translate to U.S.
|
1.3301
|
|
1.2888
|
|
|
$
|
|
$
|
|
Assets
|
|
|
|
|
Cash
|
740,620
|
556,815
|
202,277
|
156,950
|
|
740,620
|
556,815
|
202,277
|
156,950
|
Liabilities
|
|
|
|
|
Accounts
payable and accrued libilities
|
2,036,795
|
1,531,310
|
1,704,086
|
1,322,227
|
Employee
cost payable
|
295,918
|
222,478
|
277,080
|
214,980
|
|
2,332,713
|
1,753,788
|
1,981,166
|
1,537,207
|
Net
exposure
|
(1,592,073)
|
(1,196,973)
|
(1,778,889)
|
(1,380,257)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following are
the contractual maturities of the undiscounted cash flows of
financial liabilities as at November 30, 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third
parties
|
|
|
|
|
|
|
Accounts
payable
|
2,643,437
|
-
|
-
|
-
|
-
|
2,643,437
|
Accrued
liabilities
|
353,147
|
-
|
-
|
-
|
-
|
353,147
|
Related
parties
|
|
|
|
|
|
|
Employee
costs payable
|
222,478
|
-
|
-
|
-
|
-
|
222,478
|
Convertible
debentures
|
52,274
|
1,376,805
|
12,603
|
12,466
|
537,808
|
1,991,956
|
|
3,271,336
|
1,376,805
|
12,603
|
12,466
|
537,808
|
5,211,018
|
WORKING
CAPITAL
Working capital
(defined as current assets minus current liabilities) has increased
by approximately $4.5 million at November 30, 2018 from November
30, 2017, mainly as a result of an increase in cash, investment tax
credits, prepaid expenses and inventory, offset by an increase in
accounts payable and Convertible debenture. We are actively
exploring partnership opportunities for both currently approved and
yet-to-be-approved products, as well as potential international
partnership opportunities for both existing and future products.
While the Company has some flexibility with its level of
expenditures, our future operations are highly dependent upon our
ability to source additional capital to support advancing our
product pipeline through continued R&D activities and to fund
any significant expansion of our operations. Our ultimate success
will depend on whether our product candidates receive the approval
of the FDA or Health Canada and whether we are able to successfully
market approved products. We cannot be certain that we will be able
to receive FDA, Health Canada and other approvals for any of our
current or future product candidates, that we will reach the level
of sales and revenues necessary to achieve and sustain
profitability, or that we can secure other capital sources on terms
or in amounts sufficient to meet our needs or at all.
As a R&D
company, Intellipharmaceutics is eligible to receive investment tax
credits from various levels of government under the SR&ED
incentive programs. Depending on the financial condition of our
operating subsidiary Intellipharmaceutics Corp., R&D expenses
in any fiscal year could be claimed. Eligible R&D expenses
included salaries for employees involved in R&D, cost of
materials, equipment purchase as well as third party contract
services. This amount is not a reduction in income taxes but a form
of government refundable credits based on the level of R&D that
the Company carries out.
Effective October
1, 2018, the maturity date for the 2013 Debenture was extended to
April 1, 2019. In December 2018, a
principal repayment of $300,000 was made for the 2013 Debenture in
respect of the $1,500,000 loan. The Company currently
expects to repay the current outstanding principal amount of
$1,050,000 on or about April 1, 2019, if the Company then has cash
available.
On September 10,
2018, the Company completed a private placement financing of the
2018 Debenture in the principal amount of $0.5 million. The 2018
Debenture is due to mature on September 1, 2020. The 2018 Debenture
bears interest at a rate of 10% per annum, payable monthly, is
pre-payable at any time at the option of the Company and is
convertible at any time into common shares at a conversion price of
$3.00 per common share at the option of the holder. Drs. Isa
and Amina Odidi, who are directors, executive officers and
principal shareholders of our Company, provided us with the
original $500,000 of the proceeds for the 2018
Debenture.
CAPITAL
EXPENDITURES
Total capital
expenditures in the year ended November 30, 2018 were $101,178
compared to $1,898,751 in the year ended November 30, 2017. Capital
expenditures in fiscal 2018 related primarily to the purchase of
production, laboratory and computer equipment. Capital expenditures
in fiscal 2017 related primarily to the purchase of plant and
production equipment required to support our generic Seroquel
XR® launch. We anticipate limited investment in fixed assets
and equipment over the next several months due to the acceleration
of product commercialization activities, the extent of which will
depend on cash availability.
CONTRACTUAL
OBLIGATIONS
In the table below,
we set forth our enforceable and legally binding obligations and
future commitments and obligations related to all contracts. Some
of the figures we include in this table are based on
management’s estimate and assumptions about these
obligations, including their duration, the possibility of renewal,
anticipated actions by third parties, and other factors. Operating
lease obligations relate to the lease of premises for the combined
properties, comprising the Company’s premises that it
operates from at 30 Worcester Road as well as the adjoining
property at 22 Worcester Road, which is indirectly owned by the
same landlord, which will expire in November 2020, subject to a 5
year renewal option. The Company also has an option to purchase the
combined properties up to November 30, 2020 based on a fair value
purchase formula, but does not currently expect to exercise this
option in 2019.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third
parties
|
|
|
|
|
|
Accounts
payable
|
2,643,437
|
2,643,437
|
-
|
-
|
-
|
Accrued
liabilities
|
353,147
|
353,147
|
-
|
-
|
-
|
Related
parties
|
|
|
-
|
|
|
Employee
costs payable
|
222,478
|
222,478
|
-
|
-
|
-
|
Convertible
debentures
|
1,991,956
|
1,454,148
|
537,808
|
-
|
-
|
Total
contractual obligations
|
5,211,018
|
4,673,210
|
537,808
|
-
|
-
|
CONTINGENCIES
AND LITIGATION
From time to time,
we may be exposed to claims and legal actions in the normal course
of business. As at November 30, 2018, and continuing as at February
22, 2019, we are not aware of any pending or threatened material
litigation claims against us, other than as described
below.
In November 2016,
we filed an NDA for our Oxycodone ER product candidate, relying on
the 505(b)(2) regulatory pathway, which allowed us to reference
data from Purdue Pharma L.P.'s file for its OxyContin® extended
release oxycodone hydrochloride. Our Oxycodone ER application was
accepted by the FDA for further review in February 2017. We
certified to the FDA that we believed that our Oxycodone ER product
candidate would not infringe any of the OxyContin® patents
listed in the Orange Book, or that such patents are invalid, and so
notified Purdue Pharma L.P. and the other owners of the subject
patents listed in the Orange Book of such
certification.
On April 7, 2017,
we received notice that the Purdue litigation plaintiffs had
commenced patent infringement proceedings against us in the U.S.
District Court for the District of Delaware (docket number 17-392)
in respect of our NDA filing for Oxycodone ER, alleging that our
proposed Oxycodone ER infringes 6 out of the 16 patents associated
with the branded product OxyContin®, or the
OxyContin® patents, listed
in the Orange Book. The complaint seeks injunctive relief as well
as attorneys' fees and costs and such other and further relief as
the Court may deem just and proper. An answer and counterclaim have
been filed.
Subsequent to the
above-noted filing of lawsuit, 4 further such patents were listed
and published in the Orange Book. The Company then similarly
certified to the FDA concerning such further patents. On March 16,
2018, we received notice that the Purdue litigation plaintiffs had
commenced further such patent infringement proceedings against us
adding the 4 further patents. This lawsuit is also in the District
of Delaware federal court under docket number
18-404.
As a result of the
commencement of the first of these legal proceedings, the FDA is
stayed for 30 months from granting final approval to our Oxycodone
ER product candidate. That time period commenced on February 24,
2017, when the Purdue litigation plaintiffs received notice of our
certification concerning the patents, and will expire on August 24,
2019, unless the stay is earlier terminated by a final declaration
of the courts that the patents are invalid, or are not infringed,
or the matter is otherwise settled among the parties.
On or about June
26, 2018 the court issued an order to sever 6
“overlapping” patents from the second Purdue case, but
ordered litigation to proceed on the 4 new (2017-issued) patents.
An answer and counterclaim was filed July 9, 2018. The existence
and publication of additional patents in the Orange Book, and
litigation arising therefrom, is an ordinary and to be expected
occurrence in the course of such litigation.
On July 6, 2018 the
court issued a so-called “Markman” claim construction
ruling on the first case and the October 22, 2018 trial date
remained unchanged. We believe that we have non-infringement and/or
invalidity defenses to all of the asserted claims of the subject
patents both of the cases and will vigorously defend against these
claims.
On July 24, 2018,
the parties to the case mutually agreed to and did have dismissed
without prejudice the infringement claims related to the
Grünenthal ‘060 patent. The Grünenthal ‘060
patent is one of the six patents included in the original
litigation case, however, the dismissal does not by itself result
in a termination of the 30-month litigation
stay.
On October 4, 2018,
the parties mutually agreed to postpone the scheduled court date
pending a case status conference scheduled for December 17, 2018.
At that time, further trial scheduling and other administrative
matters were postponed pending the Company’s anticipated
resubmission of the Oxycodone ER NDA to the FDA, which is due no
later than February 28, 2019.
In July 2017, three
complaints were filed in the U.S. District Court for the Southern
District of New York that were later consolidated under the caption
Shanawaz v. Intellipharmaceutics Int’l Inc., et al., No.
1:17-cv-05761 (S.D.N.Y.). The lead plaintiffs filed a
consolidated amended complaint on January 29, 2018. In the amended
complaint, the lead plaintiffs assert claims on behalf of a
putative class consisting of purchasers of our securities between
May 21, 2015 and July 26, 2017. The amended complaint alleges that
the defendants violated Sections 10(b) and 20(a) of the Securities
Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by
making allegedly false and misleading statements or failing to
disclose certain information regarding our NDA for Oxycodone ER
abuse-deterrent oxycodone hydrochloride extended release tablets.
The complaint seeks, among other remedies, unspecified damages,
attorneys’ fees and other costs, equitable and/or injunctive
relief, and such other relief as the court may find just and
proper. On March 30, 2018, the Company and the other defendants
filed a motion to dismiss the amended complaint for failure to
state a valid claim. The defendants’ motion to dismiss was
granted in part, and denied in part, in an Order dated December 17,
2018. In its Order, the court dismissed certain of the
plaintiffs’ securities claims, to the extent that the claims
were based upon statements describing the Oxycodone ER
product’s abuse-deterrent features and its bioequivalence to
OxyContin. However, the court allowed the claims to proceed to the
extent plaintiffs challenged certain public statements describing
the contents of the Company’s Oxycodone ER NDA. Defendants
filed an answer to the amended complaint on January 7, 2019, and
discovery is ongoing. We intend to vigorously defend against the
remainder of the claims asserted in the consolidated
action.
On February 21,
2019, the Company and its CEO, Dr. Isa Odidi, received a Statement
of Claim concerning an action against them in the Superior Court of
Justice of Ontario under the caption Victor Romita, plaintiff, and
Intellipharmaceutics International Inc and Isa Odidi,
defendants,. The action seeks certification as a class
action and alleges that certain public statements made by the
Company in the period February 29, 2016 to July 26, 2017 knowingly
or negligently contained or omitted material facts concerning the
Company’s NDA for Oxycodone ER abuse-deterrent oxycodone
hydrochloride extended release tablets. The plaintiff alleges that
he suffered loss and damages as a result of trading in the
Company’s shares on the Toronto Stock Exchange during the
above-noted period. The claim seeks, among other remedies,
unspecified damages, legal fees and court and other costs as the
court may permit. At this time, the action has not been certified
as a class action. The Company intends to vigorously defend against
the claims asserted in this action.
RELATED
PARTY TRANSACTIONS
In January 2013,
the Company completed the private placement financing of the 2013
Debenture. The 2013 Debenture bears interest at a rate of 12% per
annum, payable monthly, is pre-payable at any time at the option of
the Company and is convertible at any time into common shares at a
conversion price of $30.00 per common share at the option of the
holder. Drs. Isa and Amina Odidi, who are directors, executive
officers and shareholders of our Company, provided us with the
original $1.5 million of the proceeds for the 2013 Debenture. In
December 2016, a principal repayment of $150,000 was made on the
2013 Debenture and the maturity date was extended until April 1,
2017. Effective March 28, 2017, the maturity date of the 2013
Debenture was extended to October 1, 2017. Effective September 28,
2017, the maturity date for the 2013 Debenture was further extended
to October 1, 2018. Effective October 1, 2018, the maturity date
for the 2013 Debenture was further extended to April 1, 2019.
In December 2018, a principal
repayment of $300,000 was made for the 2013 Debenture in respect of
the $1,500,000 loan. The Company currently expects to repay
the current outstanding principal amount of $1,050,000 on the 2013
Debenture on or about April 1, 2019, if the Company then has cash
available.
On September 10,
2018, the Company completed a private placement financing of the
2018 Debenture. The 2018 Debenture bears interest at a rate of 10%
per annum, payable monthly, may be prepaid at any time at our
option, and is convertible into Common Shares at any time prior to
the maturity date at a conversion price of $3.00 per Common Share
at the option of the holder. Drs. Isa and Amina Odidi, who are
directors, executive officers and shareholders of our Company,
provided us with the original $500,000 of proceeds for the 2018
Debenture. The maturity date for the 2018 Debenture is September 1,
2020.
To the
Company’s knowledge, Armistice Capital Master Fund, Ltd.
and/or its affiliates (collectively “Armistice”),
previously a holder of in excess of 10% of the Company’s
outstanding Common Shares, participated in (i) a registered direct
offering in October 2017, pursuant to a placement agent agreement
dated October 10, 2017 between the Company and H.C. Wainwright, and
(ii) the registered direct offerings completed in March 2018,
pursuant to placement agent agreements dated March 12, 2018 and
March 18, 2018 between the Company and H.C. Wainwright; and (iii)
the underwritten public offering completed in October 2018.
Armistice reported on a Schedule 13-G/A filed with the SEC on
February 14, 2019, that it was the beneficial owner of 9.99% of the
Company’s common shares.
The Company’s
Corporate Governance Committee, made up of independent directors,
oversees any potential transaction and negotiation that could give
rise to a related party transaction or create a conflict of
interest, and conducts an appropriate review.
DISCLOSURE
CONTROLS AND PROCEDURES
Under the
supervision and with the participation of our management, including
the Chief Executive Officer and the Chief Financial Officer, we
have evaluated the effectiveness of our disclosure controls and
procedures as of November 30, 2018. Disclosure controls and
procedures are designed to ensure that the information required to
be disclosed by the Company in the reports it files or submits
under securities legislation is recorded, processed, summarized and
reported on a timely basis and that such information is accumulated
and communicated to management, including the Company’s Chief
Executive Officer and Chief Financial Officer, as appropriate, to
allow required disclosures to be made in a timely fashion. Based on
that evaluation, management has concluded that these disclosure
controls and procedures were effective as of November 30,
2018.
INTERNAL
CONTROL OVER FINANCIAL REPORTING
The management of
our Company is responsible for establishing and maintaining
adequate internal control over financial reporting for the Company.
Internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements in accordance
with generally accepted accounting principles and includes those
policies and procedures that (1) pertain to the maintenance of
records that, in reasonable detail, accurately and fairly reflect
the transactions and dispositions of the Company’s assets,
(2) provide reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that
the Company’s receipts and expenditures are being made only
in accordance with authorizations of the Company’s management
and directors, and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or
disposition of the Company’s assets that could have a
material effect on the financial statements.
Management assessed
the effectiveness of the Company’s internal control over
financial reporting using the 1992 Internal Control-Integrated
Framework developed by the Committee of Sponsoring Organizations of
the Treadway Commission ("COSO").
Based on this
assessment, management concluded that the Company’s internal
control over financial reporting was effective as of November 30,
2018.
In the second
quarter of 2017, we initiated the transition from the COSO
1992 Internal Control - Integrated Framework to the COSO
2013 Internal Control - Integrated Framework. Management has
completed the business risk and information technology components
and is working towards completion of controls over financial
reporting as well as fraud risk. We currently expect the transition
to the new framework to continue through the second quarter of
fiscal 2019. Although we do not expect to experience significant
changes in internal control over financial reporting as a result of
our transition, we may identify significant deficiencies or
material weaknesses and incur additional costs in the future as a
result of our transition.
Changes
in Internal Control over Financial Reporting
During year ended
November 30, 2018, there were no changes made to the
Company’s internal control over financial reporting that have
materially affected, or are reasonably likely to materially affect,
the Company’s internal control over financial reporting, and
specifically, there were no changes in accounting functions, board
or related committees and charters, or auditors; no functions,
controls or financial reporting processes of any constituent
entities were adopted as the Company’s functions, controls
and financial processes; and no other significant business
processes were implemented.
OFF-BALANCE
SHEET ARRANGEMENTS
The Company, as
part of its ongoing business, does not participate in transactions
that generate relationships with unconsolidated entities or
financial partnerships, such as entities often referred to as
structured finance or special purpose entities (“SPE”),
which would have been established for the purpose of facilitating
off-balance sheet arrangements or other contractually narrow or
limited purposes. As of November 30, 2018, the Company was not
involved in any material unconsolidated SPE
transactions.
RISKS
AND UNCERTAINTIES
We are a R&D
company that received final FDA approval of our once daily generic
Focalin XR® capsules for the 15 and 30 mg strengths in
November 2013. We depend significantly on the actions of our
development partner Par in the prosecution, regulatory approval and
commercialization of our generic Focalin XR® capsules and on
its timely payment to us of the contracted quarterly payments as
they come due. Our near term ability to generate significant
revenue will depend upon successful commercialization of our
products in the U.S., where the branded Focalin XR® product is
in the market. Although we have several other products in our
pipeline, and received final approval from the FDA for our generic
Keppra XR® for the 500 and 750 mg strengths, final approval
from the FDA for our generic Glucophage XR® in the 500 and 750
mg strengths, final approval from the FDA for our generic Effexor
XR® in the 37.5, 75, and 150 mg strengths and of our generic
Seroquel XR® which is partnered with Mallinckrodt, the
majority of the products in our pipeline are at earlier stages of
development. We are exploring licensing and commercial alternatives
for our generic Seroquel XR®, generic Keppra XR®, generic
Effexor XR® and generic Glucophage XR® product strengths
that have been approved by the FDA. Potential licensing and
commercial alternatives for these products include licensing and
distribution deals for regions outside of North America. Because of
these characteristics, the Company is subject to certain risks and
uncertainties, or risk factors. The Company cannot predict or
identify all such risk factors nor can it predict the impact, if
any, of the risk factors on its business operations or the extent
to which a factor, event or any such combination may materially
change future results of financial position from those reported or
projected in any forward looking statements. Accordingly, the
Company cautions the reader not to rely on reported financial
information and forward-looking statements to predict actual future
results. This document and the accompanying financial information
should be read in conjunction with this statement concerning risks
and uncertainties. Some of the risks, uncertainties and events that
may affect the Company, its business, operations and results of
operations are given in this section. However, the factors and
uncertainties are not limited to those stated.
We believe that the
revenues derived from our generic Focalin XR® capsules are
subject to wholesaler buying patterns, increased generic
competition negatively impacting price, margins and market share
consistent with industry post-exclusivity experience and, to a
lesser extent, seasonality (as these products are indicated for
conditions including attention deficit hyperactivity disorder which
we expect may see increases in prescription rates during the school
term and declines in prescription rates during the summer months).
Accordingly, these factors may cause our operating results to
fluctuate.
Since we commenced
operations, we have incurred accumulated losses through November
30, 2018. We had an accumulated deficit of $85,620,939 as of
November 30, 2018 and have incurred additional losses since such
date. As we engage in the development of products in our pipeline,
we will continue to incur further losses. There can be no assurance
that we will ever be able to achieve or sustain profitability or
positive cash flow. Our ultimate success will depend on whether our
product candidates receive the approval of the FDA or Health Canada
and whether we are able to successfully market approved products.
We cannot be certain that we will be able to receive FDA or Health
Canada approval for any of our current or future product
candidates, that we will reach the level of sales and revenues
necessary to achieve and sustain profitability, or that we can
secure other capital sources on terms or in amounts sufficient to
meet our needs or at all.
Our business
requires substantial capital investment in order to conduct the
R&D, clinical and regulatory activities necessary and to defend
against patent litigation claims in order to bring our products to
market and to establish commercial manufacturing, marketing and
sales capabilities. In the event that we do not obtain sufficient
additional capital, it will raise substantial doubt about our
ability to continue as a going concern and realize our assets and
pay our liabilities as they become due.
Our cash outflows
are expected to consist primarily of internal and external R&D,
legal and consulting expenditures to advance our product pipeline
and selling, general and administrative expenses to support our
commercialization efforts. Depending upon the results of our
R&D programs, the impact of the litigation against us and the
availability of financial resources, we could decide to accelerate,
terminate, or reduce certain projects, or commence new ones. Any
failure on our part to successfully commercialize approved products
or raise additional funds on terms favorable to us, or at all, may
require us to significantly change or curtail our current or
planned operations in order to conserve cash until such time, if
ever, that sufficient proceeds from operations are generated, and
could result in us not taking advantage of business opportunities,
in the termination or delay of clinical trials or us not taking any
necessary actions required by the FDA or Health Canada for one or
more of our product candidates, in curtailment of our product
development programs designed to identify new product candidates,
in the sale or assignment of rights to our technologies, products
or product candidates, and/or our inability to file ANDAs, ANDSs or
NDAs at all or in time to competitively market our products or
product candidates.
We set goals
regarding the expected timing of meeting certain corporate
objectives, such as the commencement and completion of clinical
trials, anticipated regulatory approval and product launch dates.
From time to time, we may make certain public statements regarding
these goals. The actual timing of these events can vary
dramatically due to, among other things, insufficient funding,
delays or failures in our clinical trials or bioequivalence
studies, the uncertainties inherent in the regulatory approval
process, such as failure to secure requested product labeling
approvals, requests for additional information, delays in achieving
manufacturing or marketing arrangements necessary to commercialize
our product candidates and failure by our collaborators, marketing
and distribution partners, suppliers and other third parties to
fulfill contractual obligations. In addition, the possibility of a
patent infringement suit, such as the Purdue litigation, regarding
one or more of our product candidates could delay final FDA
approval of such candidates and materially adversely affect our
ability to market our products. Even if we are found not to
infringe Purdue’s or any other plaintiff’s patent
claims or the claims are found invalid or unenforceable, defending
any such infringement claims could be expensive and time-consuming
and could distract management from their normal responsibilities.
If we fail to achieve one or more of our planned goals, the price
of our common shares could decline.
Further risks and uncertainties affecting us can be found elsewhere
in this document, in our latest Annual Information Form, our latest
Form F-1 and F-3, as amended or supplemented (including any
documents forming a part thereof or incorporated by reference
therein), and our latest Form 20-F, and other public documents
filed on SEDAR and EDGAR.
ADDITIONAL INFORMATION
Additional
information relating to the Company, including the Company’s
latest Annual Information Form, our latest Form F-1 and F-3, as
amended or supplemented (including any documents forming a part
thereof or incorporated by reference therein), and latest Form
20-F, can be located under the Company’s profile on the SEDAR
website at www.sedar.com and on the EDGAR section of the
SEC’s website at www.sec.gov.
Intellipharmaceutics International Inc.
|
Consolidated
balance sheets
|
As
at November 30, 2018 and 2017
|
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
Current
|
|
|
Cash
|
6,641,877
|
1,897,061
|
Accounts
receivable, net (Note 4)
|
239,063
|
689,619
|
Investment
tax credits
|
998,849
|
636,489
|
Prepaid
expenses, sundry and other assets
|
586,794
|
225,092
|
Inventory
(Note 3)
|
251,651
|
115,667
|
|
8,718,234
|
3,563,928
|
|
|
|
Deferred
offering costs (Note 10)
|
-
|
565,302
|
Property
and equipment, net (Note 5)
|
2,755,993
|
3,267,551
|
|
11,474,227
|
7,396,781
|
|
|
|
Liabilities
|
|
|
Current
|
|
|
Accounts
payable
|
2,643,437
|
2,060,084
|
Accrued
liabilities (Note 6)
|
353,147
|
782,369
|
Employee
costs payable (Note 8)
|
222,478
|
214,980
|
Convertible
debentures (Note 7)
|
1,790,358
|
1,290,465
|
Deferred
revenue (Note 3)
|
300,000
|
300,000
|
|
5,309,420
|
4,647,898
|
|
|
|
Deferred
revenue (Note 3)
|
2,062,500
|
2,362,500
|
|
7,371,920
|
7,010,398
|
|
|
|
Shareholders' equity
|
|
|
Capital
stock (Note 10)
|
|
|
Authorized
|
|
|
Unlimited
common shares without par value
|
|
|
Unlimited
preference shares
|
|
|
Issued
and outstanding
|
|
|
18,252,243
common shares
|
44,327,952
|
35,290,034
|
(November
30, 2017 - 3,470,451)
|
|
|
Additional
paid-in capital
|
45,110,873
|
36,685,387
|
Accumulated
other comprehensive income
|
284,421
|
284,421
|
Accumulated
deficit
|
(85,620,939)
|
(71,873,459)
|
|
4,102,307
|
386,383
|
Contingencies
(Note 16)
|
|
|
|
11,474,227
|
7,396,781
|
On
behalf of the Board:
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Dr. Isa Odidi
|
/s/
Bahadur Madhani
|
|
|
Dr.
Isa Odidi, Chairman of the Board
|
Bahadur
Madhani, Director
|
|
|
See
accompanying notes to consolidated financial
statements
Intellipharmaceutics International Inc.
|
Consolidated
statements of operations and comprehensive loss
|
for the
years ended November 30, 2018, 2017 and 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
Licensing
(Note 3)
|
1,370,607
|
5,025,350
|
2,209,502
|
Up-front
fees (Note 3)
|
342,124
|
479,102
|
37,500
|
|
1,712,731
|
5,504,452
|
2,247,002
|
|
|
|
|
Cost
of goods sold
|
124,870
|
704,006
|
-
|
Gross Margin
|
1,587,861
|
4,800,446
|
2,247,002
|
|
|
|
|
Expenses
|
|
|
|
Research
and development
|
10,827,293
|
9,271,353
|
8,166,736
|
Selling,
general and administrative
|
3,476,450
|
3,287,914
|
3,546,132
|
Depreciation
(Note 5)
|
610,384
|
506,961
|
385,210
|
|
14,914,127
|
13,066,228
|
12,098,078
|
|
|
|
|
Loss
from operations
|
(13,326,266)
|
(8,265,782)
|
(9,851,076)
|
|
|
|
|
Net
foreign exchange (loss) gain
|
8,592
|
(80,093)
|
(22,470)
|
Interest
income
|
227
|
15,037
|
207
|
Interest
expense
|
(255,231)
|
(389,239)
|
(270,238)
|
Financing
cost (Note 10)
|
(174,802)
|
(137,363)
|
-
|
Net loss and comprehensive loss
|
(13,747,480)
|
(8,857,440)
|
(10,143,577)
|
|
|
|
|
Loss
per common share, basic and diluted
|
(2.89)
|
(2.86)
|
(3.80)
|
|
|
|
|
Weighted average number of common
|
|
|
|
shares outstanding, basic and diluted
|
4,762,274
|
3,101,448
|
2,669,958
|
See accompanying notes to
consolidated financial statements
Intellipharmaceutics International
Inc.
Consolidated
statements of shareholders' equity
(deficiency)
for
the years ended November 30, 2018, 2017 and
2016
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
|
Balance,
November 30, 2015
|
2,424,405
|
21,481,242
|
30,969,093
|
284,421
|
(52,872,442)
|
(137,686)
|
DSU's to
non-management board members (Note 12)
|
-
|
-
|
31,628
|
-
|
-
|
31,628
|
Stock options to
employees (Note 11)
|
-
|
-
|
2,261,444
|
-
|
-
|
2,261,444
|
Shares issued for
options exercised (Note 11)
|
2,750
|
87,259
|
(34,391)
|
-
|
-
|
52,868
|
Proceeds from
at-the-market financing (Note 10)
|
147,126
|
3,469,449
|
-
|
-
|
-
|
3,469,449
|
Proceeds from
issuance of shares and warrants (Note 10 &
14)
|
368,927
|
4,764,777
|
1,175,190
|
-
|
-
|
5,939,967
|
Share issuance cost
(Note 10)
|
-
|
(1,002,655)
|
(158,736)
|
-
|
-
|
(1,161,391)
|
Issuance of shares
on exercise of warrants (Note 14)
|
35,791
|
1,030,719
|
(330,066)
|
-
|
-
|
700,653
|
Modification of 2013
Debenture (Note 7)
|
-
|
-
|
102,909
|
-
|
-
|
102,909
|
Net
loss
|
-
|
-
|
-
|
-
|
(10,143,577)
|
(10,143,577)
|
Balance,
November 30, 2016
|
2,978,999
|
29,830,791
|
34,017,071
|
284,421
|
(63,016,019)
|
1,116,264
|
DSU's to
non-management board members (Note 12)
|
-
|
-
|
30,355
|
-
|
-
|
30,355
|
Stock options to
employees (Note 11)
|
-
|
-
|
1,749,999
|
-
|
-
|
1,749,999
|
Shares issued for
options exercised (Note 11)
|
200
|
1,100
|
642
|
-
|
-
|
1,742
|
Proceeds from
at-the-market financing (Note 10)
|
110,815
|
2,541,640
|
-
|
-
|
-
|
2,541,640
|
Proceeds from
issuance of shares and warrants (Note 10 &
14)
|
363,636
|
3,257,445
|
742,555
|
-
|
-
|
4,000,000
|
Cost of warrants
issued to placement agent (Note 14)
|
-
|
(86,196)
|
86,196
|
-
|
-
|
-
|
Share issuance cost
(Note 10)
|
-
|
(685,319)
|
(108,912)
|
-
|
-
|
(794,231)
|
Issuance of shares
on exercise of warrants (Note 14)
|
16,801
|
430,573
|
(106,315)
|
-
|
-
|
324,258
|
Modification of 2013
Debenture (Note 7)
|
-
|
-
|
273,796
|
-
|
-
|
273,796
|
Net
loss
|
-
|
-
|
-
|
-
|
(8,857,440)
|
(8,857,440)
|
Balance,
November 30, 2017
|
3,470,451
|
35,290,034
|
36,685,387
|
284,421
|
(71,873,459)
|
386,383
|
DSU's to
non-management board members (Note 12)
|
-
|
-
|
7,565
|
-
|
-
|
7,565
|
Stock options to
employees (Note 11)
|
-
|
-
|
927,686
|
-
|
-
|
927,686
|
Proceeds from
issuance of shares and warrants (Note 10 &
14)
|
3,658,564
|
5,993,472
|
13,651,434
|
-
|
-
|
19,644,906
|
Proceeds from
exercise of Pre-Funded Warrants (Note 14)
|
11,123,334
|
4,012,528
|
(3,901,275)
|
-
|
-
|
111,253
|
Shares to be issued
from exercise of Pre-Funded Warrants (Note 10 &
14)
|
-
|
371,551
|
(361,251)
|
|
|
10,300
|
Cost of warrants
issued to placement agent (Note 14)
|
-
|
(602,981)
|
602,981
|
-
|
-
|
-
|
Share issuance cost
(Note 10)
|
-
|
(736,652)
|
(2,568,321)
|
-
|
-
|
(3,304,973)
|
Beneficial
conversion feature related to 2018 Debenture (Note
7)
|
-
|
-
|
66,667
|
-
|
-
|
66,667
|
Net
loss
|
-
|
-
|
-
|
-
|
(13,747,480)
|
(13,747,480)
|
Rounding of
fractional shares after consolidation (Note 2)
|
(106)
|
-
|
-
|
-
|
-
|
-
|
Balance,
November 30, 2018
|
18,252,243
|
44,327,952
|
45,110,873
|
284,421
|
(85,620,939)
|
4,102,307
|
See accompanying notes to
consolidated financial statements
Intellipharmaceutics International Inc.
Consolidated
statements of cash flows
for
the years ended November 30, 2018, 2017 and 2016
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
(13,747,480)
|
(8,857,440)
|
(10,143,577)
|
Items
not affecting cash
|
|
|
|
Depreciation
(Note 5)
|
612,736
|
520,838
|
385,210
|
Stock-based
compensation (Note 11)
|
927,686
|
1,749,999
|
2,261,444
|
Deferred
share units (Note 12)
|
7,565
|
30,355
|
31,628
|
Accreted
interest (Note 7)
|
66,560
|
219,497
|
79,245
|
Financing
cost (Note 10)
|
174,802
|
137,363
|
-
|
Provision
for doubtful debts (Note 4)
|
-
|
66,849
|
-
|
Unrealized
foreign exchange loss (gain)
|
52,613
|
56,998
|
22,916
|
|
|
|
|
Change
in non-cash operating assets & liabilities
|
|
|
|
Accounts
receivable
|
450,556
|
(283,994)
|
6,200
|
Investment
tax credits
|
(362,360)
|
44,647
|
(223,115)
|
Prepaid
expenses, sundry and other assets
|
(361,702)
|
175,550
|
(171,417)
|
Inventory
|
(135,984)
|
(115,667)
|
-
|
Accounts
payable, accrued liabilities and employee costs
payable
|
106,048
|
599,220
|
(1,466,019)
|
Deferred
revenue
|
(300,000)
|
(450,000)
|
2,962,500
|
Cash
flows used in operating activities
|
(12,508,960)
|
(6,105,785)
|
(6,254,985)
|
|
|
|
|
Financing activities
|
|
|
|
Repayment
of 2013 Debenture (Note 7)
|
-
|
(150,000)
|
-
|
2018
Debenture financing (Note 7)
|
500,000
|
-
|
-
|
Repayment
of capital lease obligations
|
-
|
(14,829)
|
(21,291)
|
Issuance
of shares on exercise of stock options (Note 11)
|
-
|
1,742
|
52,868
|
Issuance
of common shares on at-the-market financing, gross (Note
10)
|
-
|
2,541,640
|
3,469,449
|
Proceeds
from issuance of shares and warrants (Note 10)
|
19,644,906
|
4,000,000
|
5,939,967
|
Proceeds
from issuance of shares on exercise of warrants (Note
14)
|
111,253
|
324,258
|
700,653
|
Proceeds
from shares to be issued from exercise of Pre-Funded Warrants (Note
14)
|
10,300
|
-
|
-
|
Offering
costs
|
(2,911,505)
|
(1,020,643)
|
(982,023)
|
Cash
flows provided from financing activities
|
17,354,954
|
5,682,168
|
9,159,623
|
|
|
|
|
Investing activity
|
|
|
|
Purchase
of property and equipment (Note 5)
|
(101,178)
|
(1,823,746)
|
(515,410)
|
Cash
flows used in investing activities
|
(101,178)
|
(1,823,746)
|
(515,410)
|
|
|
|
|
Increase
(decrease) in cash
|
4,744,816
|
(2,247,363)
|
2,389,228
|
Cash,
beginning of year
|
1,897,061
|
4,144,424
|
1,755,196
|
Cash, end of year
|
6,641,877
|
1,897,061
|
4,144,424
|
|
|
|
|
Supplemental cash flow information
|
|
|
|
Interest
paid
|
209,675
|
123,204
|
165,585
|
Taxes
paid
|
-
|
-
|
-
|
See accompanying notes to
consolidated financial statements
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
Intellipharmaceutics
International Inc. (“IPC” or the “Company”)
is a pharmaceutical company specializing in the research,
development and manufacture of novel and generic controlled-release
and targeted-release oral solid dosage drugs.
On October 22,
2009, IntelliPharmaCeutics Ltd. (“IPC Ltd. “) and
Vasogen Inc. (“Vasogen”) completed a court approved
plan of arrangement and merger (the “IPC Arrangement
Agreement”), resulting in the formation of the Company, which
is incorporated under the laws of Canada. The Company’s
common shares are traded on the Toronto Stock Exchange
(“TSX”) and the Nasdaq Capital Market
(“Nasdaq”).
The Company earns
revenue from non-refundable upfront fees, milestone payments upon
achievement of specified research or development, exclusivity
milestone payments and licensing and cost plus payments on sales of
resulting products. In November 2013, the U.S. Food and Drug
Administration (“FDA”) granted the Company final
approval to market the Company’s first product, the 15 mg and
30 mg strengths of the Company’s generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules. In
2017, the FDA granted final approval for the remaining 6 (six)
strengths, all of which have been launched. In May 2017, the FDA
granted the Company final approval for its second commercialized
product, the 50, 150, 200, 300 and 400 mg strengths of generic
Seroquel XR® (quetiapine fumarate extended release) tablets,
and the Company commenced shipment of all strengths that same
month. In November 2018, the FDA granted the Company final approval
for its venlafaxine hydrochloride extended-release capsules in the
37.5, 75, and 150 mg strengths.
Going concern
The consolidated
financial statements are prepared on a going concern basis, which
assumes that the Company will be able to meet its obligations and
continue its operations for the next twelve months. The Company has
incurred losses from operations since inception and has reported
losses of $13,747,480 for the year ended November 30, 2018 (2017 -
$8,857,440; 2016 - $10,143,577), and has an accumulated deficit of
$85,620,939 as at November 30, 2018 (November 30, 2017 -
$71,873,459). The Company has a working capital of $3,408,814 as at
November 30, 2018 (November 30, 2017 – working capital
deficiency of $1,083,970). The Company has funded its research and
development (“R&D”) activities principally through
the issuance of securities, loans from related parties, funds from
the IPC Arrangement Agreement, and funds received under development
agreements. There is no certainty that such funding will be
available going forward. These conditions raise substantial doubt
about its ability to continue as a going concern and realize its
assets and pay its liabilities as they become due.
In order for the
Company to continue as a going concern and fund any significant
expansion of its operation or R&D activities, the Company may
require significant additional capital. Although there can be no
assurances, such funding may come from revenues from the sales of
the Company’s generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules, from revenues from the
sales of the Company’s generic Seroquel XR® (quetiapine
fumarate extended-release) tablets and from potential partnering
opportunities. Other potential sources of capital may include
payments from licensing agreements, cost savings associated with
managing operating expense levels, other equity and/or debt
financings, and/or new strategic partnership agreements which fund
some or all costs of product development. The Company’s
ultimate success will depend on whether its product candidates
receive the approval of the FDA or Health Canada and whether it is
able to successfully market approved products.
The Company cannot
be certain that it will be able to receive FDA or Health Canada
approval for any of its current or future product candidates, or
that it will reach the level of sales and revenues necessary to
achieve and sustain profitability, or that the Company can secure
other capital sources on terms or in amounts sufficient to meet its
needs.
The availability of
equity or debt financing will be affected by, among other things,
the results of the Company’s R&D, its ability to obtain
regulatory approvals, its success in commercializing approved
products with its commercial partners and the market acceptance of
its products, the state of the capital markets generally, strategic
alliance agreements, and other relevant commercial considerations.
In addition, if the Company raises additional funds by issuing
equity securities, its then existing security
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
1.
Nature
of operations (continued)
Going concern (continued)
holders will likely
experience dilution, and the incurring of indebtedness would result
in increased debt service obligations and could require the Company
to agree to operating and financial covenants that would restrict
its operations. Any failure on its part to successfully
commercialize approved products or raise additional funds on terms
favorable to the Company or at all, may require the Company to
significantly change or curtail its current or planned operations
in order to conserve cash until such time, if ever, that sufficient
proceeds from operations are generated, and could result in the
Company not taking advantage of business opportunities, in the
termination or delay of clinical trials or the Company not taking
any necessary actions required by the FDA or Health Canada for one
or more of the Company’s product candidates, in curtailment
of the Company’s product development programs designed to
identify new product candidates, in the sale or assignment of
rights to its technologies, products or product candidates, and/or
its inability to file Abbreviated New Drug Applications
(“ANDAs”), Abbreviated New Drug Submissions
(“ANDSs”) or New Drug Applications (“NDAs”)
at all or in time to competitively market its products or product
candidates.
The consolidated
financial statements do not include any adjustments that might
result from the outcome of uncertainties described above. If the
going concern assumption no longer becomes appropriate for these
consolidated financial statements, then adjustments would be
necessary to the carrying values of assets and liabilities, the
reported expenses and the balance sheet classifications used. Such
adjustments could be material.
(a)
Basis of consolidation
These consolidated
financial statements include the accounts of the Company and its
wholly owned operating subsidiaries, IPC Ltd., Intellipharmaceutics
Corp. (“IPC Corp”), and Vasogen Corp.
References in these
consolidated financial statements to share amounts, per share data,
share prices, exercise prices and conversion rates have been
adjusted to reflect the effect of the 1-for-10 reverse split which
became effective on each of Nasdaq and TSX at the opening of the
market on September 14, 2018.
In September 2018,
the Company announced a one-for-ten share consolidation (the
“reverse split”). At a special meeting of the
Company’s shareholders held on August 15, 2018, the
Company’s shareholders granted the Company’s Board of
Directors discretionary authority to implement a consolidation of
the issued and outstanding common shares of the Company on the
basis of a consolidation ratio within a range from five (5)
pre-consolidation common shares for one (1) post-consolidation
common share to fifteen (15) pre-consolidation common shares for
one (1) post-consolidation common share. The Board of Directors
selected a share consolidation ratio of ten (10) pre-consolidation
shares for one (1) post-consolidation common share. On September
12, 2018, the Company filed an amendment to the Company’s
articles ("Articles of Amendment") to implement the one-for-10
reverse split. The Company’s common shares began trading on
each of the Nasdaq and TSX on a post-split basis under the
Company’s existing trade symbol "IPCI" at the opening of the
market on September 14, 2018. In accordance with accounting
principles generally accepted in the United States of America
(“U.S. GAAP”), the change has been applied
retroactively.
All inter-company
accounts and transactions have been eliminated on
consolidation.
The preparation of
the consolidated financial statements in conformity with U.S. GAAP
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenue and expenses during
the year. Actual results could differ from those
estimates.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
2.
Basis
of presentation (continued)
(b)
Use of estimates (continued)
Areas where
significant judgment is involved in making estimates are: the
determination of the functional currency; the fair values of
financial assets and liabilities; the determination of units of
accounting for revenue recognition; the accrual of licensing and
milestone revenue; and forecasting future cash flows for assessing
the going concern assumption.
3.
Significant
accounting policies
(a)
Cash and cash equivalents
The Company
considers all highly liquid securities with an original maturity of
three months or less to be cash equivalents. Cash equivalent
balances consist of bankers’ acceptances and bank accounts with variable
market rates of interest. The financial risks associated with these
instruments are minimal and the Company has not experienced any
losses from investments in these securities. The carrying amount of
cash approximates its fair value due to its short-term
nature.
As at November 30,
2018 and 2017, the Company had no cash equivalents.
The Company reviews
its sales and accounts receivable aging and determines whether an
allowance for doubtful accounts is required.
(c)
Financial instruments
The Company
evaluates all of its financial instruments to determine if such
instruments are derivatives or contain features that qualify as
embedded derivatives. For derivative financial instruments that are
classified as liabilities, the derivative instrument is initially
recorded at its fair value using the appropriate valuation
methodology and is then re-valued at each reporting date, with
changes in the fair value reported in the consolidated statements
of operations and comprehensive loss.
(d)
Investment tax credits
The investment tax
credits (“ITC") receivable are amounts considered recoverable
from the Canadian federal and provincial governments under the
Scientific Research & Experimental Development
(“SR&ED”) incentive program. The amounts claimed
under the program represent the amounts based on management
estimates of eligible research and development costs incurred
during the year. Realization is subject to government approval. Any
adjustment to the amounts claimed will be recognized in the year in
which the adjustment occurs. Refundable ITCs claimed relating to
capital expenditures are credited to property and equipment.
Refundable ITCs claimed relating to current expenditures are netted
against research and development expenditures.
(e)
Property and equipment
Property and
equipment are recorded at cost. Equipment acquired under capital
leases are recorded net of imputed interest, based upon the net
present value of future payments. Assets under capital leases are
pledged as collateral for the related lease obligation. Repairs and
maintenance expenditures are charged to operations; major
betterments and replacements are capitalized. Depreciation bases
and rates are as follows:
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(e)
Property and equipment (continued)
Assets
|
Basis
|
Rate
|
|
|
|
Computer
equipment
|
Declining
balance
|
30%
|
Computer
software
|
Declining
balance
|
50%
|
Furniture
and fixtures
|
Declining
balance
|
20%
|
Laboratory
equipment
|
Declining
balance
|
20%
|
Leasehold
improvements
|
Straight
line
|
Over
term of lease
|
Leasehold
improvements and assets acquired under capital leases are
depreciated over the term of their useful lives or the lease
period, whichever is shorter. The charge to operations resulting
from depreciation of assets acquired under capital leases is
included with depreciation expense.
(f)
Impairment of long-lived assets
Long-lived assets
are reviewed for impairment when events or circumstances indicate
that the carrying value of an asset may not be recoverable. For
assets that are to be held and used, impairment is recognized when
the sum of estimated undiscounted cash flows associated with the
asset or group of assets is less than its carrying value. If
impairment exists, an adjustment is made to write the asset down to
its fair value, and a loss is recorded as the difference between
the carrying value and fair value.
The Company
previously issued warrants as described in Notes 10 and 14. In
fiscal 2013, the outstanding warrants were presented as a liability
because they did not meet the criteria of Accounting Standard
Codification (“ASC”) topic 480 Distinguishing
Liabilities from Equity for equity classification. Subsequent
changes in the fair value of the warrants were recorded in the
consolidated statements of operations and comprehensive loss. The
Company changed its functional currency effective December 1, 2013
such that these warrants met the criteria for prospective equity
classification in ASC topic 480, and the U.S. dollar translated
amount of the warrant liability at December 1, 2013 became the
amount reclassified to equity.
(h)
Convertible
debentures
In fiscal 2013, the
Company issued an unsecured convertible debenture in the principal
amount of $1.5 million (the “2013 Debenture”) as
described in Note 7. At issuance, the conversion option was
bifurcated from its host contract and the fair value of the
conversion option was characterized as an embedded derivative upon
issuance as it met the criteria of ASC topic 815 Derivatives and
Hedging. Subsequent changes in the fair value of the embedded
derivative were recorded in the consolidated statements of
operations and comprehensive loss. The proceeds received from the
2013 Debenture less the initial amount allocated to the embedded
derivative were allocated to the liability and were accreted over
the life of the 2013 Debenture using the effective rate of
interest. The Company changed its functional currency effective
December 1, 2013 such that the conversion option no longer met the
criteria for bifurcation and was prospectively reclassified to
shareholders’ equity under ASC Topic 815 at the U.S. dollar
translated amount at December 1, 2013.
On September 10,
2018, the Company completed a private placement financing of an
unsecured convertible debenture in the principal amount of $0.5
million (the “2018 Debenture”) as described in Note 7.
At issuance, the conversion price was lower than the market share
price, and the value of the beneficial conversion feature related
to the 2018 Debenture was allocated to shareholders’
equity.
The Company
accounts for revenue in accordance with the provisions of ASC topic
605 Revenue Recognition. The Company earns revenue from
non-refundable upfront fees, milestone payments upon achievement of
specified research or development, exclusivity milestone payments
and licensing payments on sales of resulting products. Revenue is
realized or realizable and earned when
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(i)
Revenue recognition (continued)
evidence of an
arrangement exists, delivery has occurred or services have been
rendered, the price to the customer is fixed or determinable, and
collectability is reasonably assured. From time to time, the
Company enters into transactions that represent multiple-element
arrangements. Management evaluates arrangements with multiple
deliverables to determine whether the deliverables represent one or
more units of accounting for the purpose of revenue
recognition.
A delivered item is
considered a separate unit of accounting if the delivered item has
stand-alone value to the customer, the fair value of any
undelivered items can be reliably determined, and the delivery of
undelivered items is probable and substantially in the Company's
control.
The relevant
revenue recognition accounting policy is applied to each separate
unit of accounting.
Licensing
The Company
recognizes revenue from the licensing of the Company's drug
delivery technologies, products and product candidates. Licensing
revenue is recognized as earned in accordance with the contract
terms when the amounts can be reasonably estimated and
collectability is reasonably assured.
The Company has a
license and commercialization agreement with Par Pharmaceutical
Inc. (“Par”). Under the exclusive territorial license
rights granted to Par, the agreement requires that Par manufacture,
promote, market, sell and distribute the product. Licensing revenue
amounts receivable by the Company under this agreement are
calculated and reported to the Company by Par, with such amounts
generally based upon net product sales and net profit which include
estimates for chargebacks, rebates, product returns, and other
adjustments. Licensing revenue payments received by the Company
from Par under this agreement are not subject to further deductions
for chargebacks, rebates, product returns, and other pricing
adjustments. Based on this arrangement and the guidance per ASC
topic 605, the Company records licensing revenue as earned in the
consolidated statements of operations and comprehensive
loss.
The Company also
has a license and commercial supply agreement with Mallinckrodt LLC
(“Mallinckrodt”) which provides Mallinckrodt an
exclusive license to market, sell and distribute in the U.S. three
drug product candidates for which the Company has ANDAs filed with
the FDA, one of which (the Company’s generic Seroquel
XR®) received final approval from the FDA in 2017. Under the
terms of this agreement, the Company is responsible for the
manufacture of approved products for subsequent sale by
Mallinckrodt in the U.S. market. Following receipt of final FDA
approval for its generic Seroquel XR®, the Company began
shipment of manufactured product to Mallinckrodt.
Licensing revenue
in respect of manufactured product is reported as revenue in
accordance with ASC topic 605. Once product is sold by
Mallinckrodt, the Company receives downstream licensing revenue
amounts calculated and reported by Mallinckrodt, with such amounts
generally based upon net product sales and net profit which
includes estimates for chargebacks, rebates, product returns, and
other adjustments. Such downstream licensing revenue payments
received by the Company under this agreement are not subject to
further deductions for chargebacks, rebates, product returns, and
other pricing adjustments. Based on this agreement and the guidance
per ASC topic 605, the Company records licensing revenue as earned
in the consolidated statements of operations and comprehensive
loss.
Milestones
The milestone
method recognizes revenue on substantive milestone payments in the
period the milestone is achieved. Milestones are considered
substantive if all of the following conditions are met: (i) the
milestone is commensurate with either the vendor’s
performance to achieve the milestone or the enhancement of the
value of the delivered item or items as a result of a specific
outcome resulting from the vendor’s performance to achieve
the milestone; (ii) the milestone relates solely to past
performance; and (iii) the milestone is reasonable relative to all
of the deliverables and payment terms
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(i)
Revenue recognition (continued)
Milestones (continued)
within the
arrangement. Non-substantive milestone payments that might be paid
to the Company based on the passage of time or as a result of a
partner’s performance are allocated to the units of
accounting within the arrangement; they are recognized as revenue
in a manner similar to those units of accounting.
Research and development
Under arrangements
where the license fees and research and development activities can
be accounted for as a separate unit of accounting, non-refundable
upfront license fees are deferred and recognized as revenue on a
straight-line basis over the expected term of the Company's
continued involvement in the research and development
process.
Deferred revenue
Deferred revenue
represents the funds received from clients, for which the revenues
have not yet been earned, as the milestones have not been achieved,
or in the case of upfront fees for drug development, where the work
remains to be completed. During the year ended November 30, 2016,
the Company received an up-front payment of $3,000,000 from
Mallinckrodt pursuant to the Mallinckrodt license and commercial
supply agreement, and initially recorded it as deferred revenue, as
it did not meet the criteria for recognition. For the year ended
November 30, 2018, the Company recognized $300,000 (2017 -
$300,000) of revenue based on a straight-line basis over the
expected term of the Mallinckrodt agreement of 10 years. In 2015,
the Company received an up-front payment of $150,000 from Teva
Pharmaceuticals USA, Inc. which the Company recognized as revenue
during the year ended November 30, 2017. As of November 30, 2018,
the Company has recorded a deferred revenue balance of $2,362,500
(November 30, 2017 - $2,662,500) relating to the underlying
contracts, of which $300,000 (November 30, 2017 - $300,000) is
considered a current portion of deferred revenue.
(j)
Research and development costs
Research and
development costs related to continued research and development
programs are expensed as incurred in accordance with ASC topic 730.
However, materials and equipment are capitalized and amortized over
their useful lives if they have alternative future
uses.
Inventories
comprise raw materials, work in process, and finished goods, which
are valued at the lower of cost or market, on a first-in, first-out
basis. Cost for work in process and finished goods inventories
includes materials, direct labor, and an allocation of
manufacturing overhead. Market for raw materials is replacement
cost, and for work in process and finished goods is net realizable
value. The Company evaluates the carrying value of inventories on a
regular basis, taking into account such factors as historical and
anticipated future sales compared with quantities on hand, the
price the Company expects to obtain for products in their
respective markets compared with historical cost and the remaining
shelf life of goods on hand. As of November 30, 2018, the Company
had raw materials inventories of $144,659 (2017 - $115,667), work
in process of $73,927 (2017 - $Nil) and finished goods inventory of
$33,065 (2017 - $Nil) relating to the Company’s generic
Seroquel XR® product. The recoverability of the cost of any
pre-launch inventories with a limited shelf life is evaluated based
on the specific facts and circumstances surrounding the timing of
the anticipated product launch.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
The Company uses
the liability method of accounting for income taxes. Under the
liability method, deferred tax assets and liabilities are
recognized for the future tax consequences attributable to
differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases and
for losses and tax credit carry forwards. Significant judgment is
required in determining whether deferred tax assets will be
realized in full or in part. Deferred tax assets and liabilities
are measured using enacted tax rates expected to apply to taxable
income in the years in which those temporary differences are
expected to be recovered or settled. The effect on deferred tax
assets and liabilities of a change in tax rates is recognized in
income in the year that includes the date of enactments. A
valuation allowance is provided for the portion of deferred tax
assets that is more likely than not to remain
unrealized.
The Company
accounts for income taxes in accordance with ASC topic 740-10. This
ASC topic requires that uncertain tax positions are evaluated in a
two-step process, whereby (i) the Company determines whether
it is more likely than not that the tax positions will be sustained
based on the technical merits of the position and (ii) those tax
positions that meet the more likely than not recognition threshold,
the Company would recognize the largest amount of tax benefit that
is greater than 50% likely of being realized upon ultimate
settlement with the related tax authority. Changes in recognition
or measurement are reflected in the period in which the change in
judgment occurs. The cumulative effects of the application of the
provisions of ASC topic 740-10 are described in
Note 15.
The Company records
any interest related to income taxes in interest expense and
penalties in selling, general and administrative
expense.
Share issue costs
are recorded as a reduction of the proceeds from the issuance of
capital stock.
(n)
Translation of foreign currencies
Transactions
denominated in currencies other than the Company and its wholly
owned operating subsidiaries’ functional currencies, monetary
assets and liabilities are translated at the period end rates.
Revenue and expenses are translated at rates of exchange prevailing
on the transaction dates. All of the exchange gains or losses
resulting from these other transactions are recognized in the
consolidated statements of operations and comprehensive
loss.
The functional and
reporting currency of the Company and its subsidiaries is the U.S.
dollar.
(o)
Stock-based compensation
The Company has a
stock-based compensation plan which authorizes the granting of
various equity-based incentives including stock options and
restricted share units (“RSU”s). The Company calculates
stock-based compensation using the fair value method, under which
the fair value of the options at the grant date is calculated using
the Black-Scholes Option Pricing Model, and subsequently expensed
over the vesting period of the option. The provisions of the
Company's stock-based compensation plans do not require the Company
to settle any options by transferring cash or other assets, and
therefore the Company classifies the awards as equity. Stock-based
compensation expense recognized during the year is based on the
value of stock-based payment awards that are ultimately expected to
vest.
The Company
estimates forfeitures at the time of grant and are revised, if
necessary, in subsequent periods if actual forfeitures differ from
those estimates. The stock-based compensation expense is recorded
in the consolidated statements of operations and comprehensive loss
under research and development expense and under selling, general
and administration expense. Note 11 provides supplemental
disclosure of the Company's stock options.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
Deferred Share
Units (“DSU”s) are valued based on the trading price of
the Company’s common shares on the Toronto Stock Exchange.
The Company records the value of the DSU’s owing to
non-management board members in the consolidated statement of
shareholders’ equity (deficiency).
Basic loss per
share (“EPS”) is computed by dividing the loss
attributable to common shareholders by the weighted average number
of common shares outstanding. Diluted EPS reflects the potential
dilution that could occur from common shares issuable through the
exercise or conversion of stock options, restricted stock awards,
warrants and convertible securities. In certain circumstances, the
conversion of options, warrants and convertible securities are
excluded from diluted EPS if the effect of such inclusion would be
anti-dilutive.
The dilutive effect
of stock options is determined using the treasury stock method.
Stock options and warrants to purchase 22,540,535, 980,791 and
754,027 common shares of the Company during fiscal 2018, 2017, and
2016, respectively, were not included in the computation of diluted
EPS because the Company has incurred a loss for the years ended
November 30, 2018, 2017 and 2016 as the effect would be
anti-dilutive.
The Company follows
ASC topic 220. This statement establishes standards for reporting
and display of comprehensive (loss) income and its components.
Comprehensive loss is net loss plus certain items that are recorded
directly to shareholders' equity (deficiency). Other than foreign
exchange gains and losses arising from cumulative translation
adjustments, the Company has no other comprehensive loss
items.
(s)
Fair value measurement
Under ASC topic
820, fair value is defined as the price that would be received to
sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date
(i.e., an exit price). ASC topic 820 establishes a hierarchy for
inputs to valuation techniques used in measuring fair value that
maximizes the use of observable inputs and minimizes the use of
unobservable inputs by requiring that the most observable inputs be
used when available. Observable inputs are inputs that reflect
assumptions market participants would use in pricing the asset or
liability developed based on market data obtained from sources
independent of the Company. Unobservable inputs are inputs that
reflect the Company's own assumptions about the assumptions market
participants would use in pricing the asset or liability developed
based on the best information available in the circumstances. There
are three levels to the hierarchy based on the reliability of
inputs, as follows:
●
Level 1 -
Observable inputs that reflect quoted prices (unadjusted) for
identical assets or liabilities in active markets.
●
Level 2 - Inputs
other than quoted prices included in Level 1 that are observable
for the asset or liability, either directly or indirectly. Level 2
inputs include quoted prices for similar assets or liabilities in
active markets, or quoted prices for identical or similar assets
and liabilities in markets that are not active.
●
Level 3 -
Unobservable inputs for the asset or liability.
The degree of
judgment exercised by the Company in determining fair value is
greatest for instruments categorized in Level 3.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(t)
Recently adopted accounting pronouncements
In August 2016,
the Financial Accounting Standards Board ("FASB")
issued Accounting Standards Update (“ASU”) No.
2016-15, Statement of Cash Flows (Topic 230) Classification of
Certain Cash Receipts and Cash Payments, which makes eight targeted
changes to how cash receipts and cash payments are presented and
classified in the Statement of Cash Flows. ASU 2016-15 became
effective on May 1, 2018. The Company adopted ASU 2016-15 and the
amendments did not have any material impact on the Company’s
financial position, results of operations, cash flows or
disclosures.
(u)
Future accounting pronouncements
In May 2014, the
FASB issued ASU No. 2014-09 (“Topic 606”), Revenue from
Contracts with Customers, requiring an entity to recognize the
amount of revenue to which it expects to be entitled for the
transfer of promised goods or services to customers. The updated
standard will replace most existing revenue recognition guidance in
U.S. GAAP when it becomes effective. In March 2016, the FASB issued
ASU No. 2016-08 to clarify the implementation guidance on
considerations of whether an entity is a principal or an agent,
impacting whether an entity reports revenue on a gross or net
basis. In April 2016, the FASB issued ASU No. 2016-10 to clarify
guidance on identifying performance obligations and the
implementation guidance on licensing. In May 2016, the FASB issued
amendments ASU No. 2016-11 and 2016-12 to amend certain aspects of
the new revenue guidance (including transition, collectability,
noncash consideration and the presentation of sales and other
similar taxes) and provided certain practical expedients. The
guidance is effective for annual reporting periods beginning after
December 15, 2017 (including interim reporting periods). Early
adoption is permitted but not before the annual reporting period
(and interim reporting period) beginning January 1, 2017. Entities
have the option of using either a full retrospective or a modified
approach to adopt the guidance. The Company anticipates that the
adoption of Topic 606 will not have a material impact on the
Company’s financial position, results of operations, and cash
flows.
In January 2016,
the FASB issued ASU No. 2016-01, which makes limited amendments to
the guidance in U.S. GAAP on the classification and measurement of
financial instruments. The new standard significantly revises an
entity’s accounting related to (1) the classification and
measurement of investments in equity securities and (2) the
presentation of certain fair value changes for financial
liabilities measured at fair value. It also amends certain
disclosure requirements associated with the fair value of financial
instruments. ASU No. 2016-01 is effective for fiscal years
beginning after December 15, 2017, and interim periods within those
annual periods. The Company anticipates that the adoption of this
standard will not have a material impact on the Company’s
financial position, results of operations, and cash
flows.
In February 2016,
the FASB issued new guidance, ASU No. 2016-02, Leases (Topic 842).
The main difference between current U.S. GAAP and the new guidance
is the recognition of lease liabilities based on the present value
of remaining lease payments and corresponding lease assets for
operating leases under current U.S. GAAP with limited exception.
Additional qualitative and quantitative disclosures are also
required by the new guidance. Topic 842 is effective for annual
reporting periods (including interim reporting periods) beginning
after December 15, 2018. Early adoption is permitted. The Company
is in the process of evaluating the amendments to determine if they
have a material impact on the Company’s financial position,
results of operations, cash flows or disclosures.
In August 2016, the
FASB issued ASU 2017-01 that changes the definition of a business
to assist entities with evaluating when a set of transferred assets
and activities is a business. The guidance requires an entity to
evaluate if substantially all of the fair value of the gross assets
acquired is concentrated in a single identifiable asset or a group
of similar identifiable assets; if so, the set of transferred
assets and activities is not a business. ASU 2017-01 also requires
a business to include at least one substantive process and narrows
the definition of outputs by more closely
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(u)
Future accounting pronouncements (continued)
aligning it with
how outputs are described in ASC 606.1. ASU 2017-01 is effective
for public business entities for fiscal years beginning after
December 15, 2017, and interim periods within those years. Early
adoption is permitted. The Company does not expect the adoption of
the amendments to have a material impact on the Company’s
financial position, results of operations, cash flows or
disclosures.
In May 2017, the
FASB issued ASU 2017-09 in relation to Compensation —Stock
Compensation (Topic 718), Modification Accounting. The amendments
provide guidance on changes to the terms or conditions of a
share-based payment award, which require an entity to apply
modification accounting in Topic 718. The amendments are effective
for all entities for annual periods, and interim periods within
those annual periods, beginning after December 15, 2017. Early
adoption is permitted, including adoption in any interim period,
for (1) public business entities for reporting periods for which
financial statements have not yet been issued and (2) all other
entities for reporting periods for which financial statements have
not yet been made available for issuance. The amendments should be
applied prospectively to an award modified on or after the adoption
date. The Company does not expect the adoption of the amendments to
have a material impact on the Company’s financial position,
results of operations, cash flows or disclosures.
The Company
currently has no debt agreements in place whereby any amount of
receivables serve as collateral. The Company has no
off-balance-sheet credit exposures and has no foreclosed or
repossessed assets. Accounts receivable are carried on the
consolidated balance sheet net of allowance for doubtful accounts.
This provision is established based on the Company’s best
estimates regarding the ultimate recovery of balances for which
collection is uncertain. As at November 30, 2018, the Company has
an account receivable balance of $305,912 (2017 - $756,468) and an
allowance for doubtful accounts of $66,849 (2017 - $66,849). Risks
and uncertainties and credit quality information related to
accounts receivable have been disclosed in Note 17.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
5.
Property
and equipment
|
|
|
|
|
|
Laboratory
equipment under capital lease
|
Computer equipment
under capital lease
|
|
Cost
|
|
|
|
|
|
|
|
|
Balance at November
30, 2016
|
$295,296
|
$124,151
|
$129,860
|
$3,933,693
|
$1,205,811
|
$276,300
|
$76,458
|
$6,041,569
|
Additions
|
235,454
|
31,908
|
42,638
|
1,353,110
|
235,641
|
-
|
-
|
1,898,751
|
Balance at November
30, 2017
|
530,750
|
156,059
|
172,498
|
5,286,803
|
1,441,452
|
276,300
|
76,458
|
7,940,320
|
Additions
|
20,336
|
-
|
-
|
80,842
|
-
|
-
|
-
|
101,178
|
Balance at November
30, 2018
|
551,086
|
156,059
|
172,498
|
5,367,645
|
1,441,452
|
276,300
|
76,458
|
8,041,498
|
|
|
|
|
|
|
|
|
|
Accumulated
depreciation
|
|
|
|
|
|
|
|
|
Balance at November
30, 2016
|
238,672
|
117,506
|
109,243
|
2,290,074
|
1,143,792
|
179,422
|
73,222
|
4,151,931
|
Depreciation
|
47,811
|
13,622
|
10,747
|
379,158
|
49,154
|
19,376
|
970
|
520,838
|
Balance at November
30, 2017
|
286,483
|
131,128
|
119,990
|
2,669,232
|
1,192,946
|
198,798
|
74,192
|
4,672,769
|
Depreciation
|
77,179
|
12,465
|
10,501
|
413,576
|
82,835
|
15,500
|
680
|
612,736
|
Balance at November
30, 2018
|
363,662
|
143,593
|
130,491
|
3,082,808
|
1,275,781
|
214,298
|
74,872
|
5,285,505
|
|
|
|
|
|
|
|
|
|
Net
book value at:
|
|
|
|
|
|
|
|
|
November 30,
2017
|
$244,267
|
$24,931
|
$52,508
|
$2,617,571
|
$248,506
|
$77,502
|
$2,266
|
$3,267,551
|
Balance at November
30, 2018
|
$187,424
|
$12,466
|
$42,007
|
$2,284,837
|
$165,671
|
$62,002
|
$1,586
|
$2,755,993
|
As at November 30,
2018, there was $595,589 (November 30, 2017 - $728,309; November
30, 2016 - $266,963) of laboratory equipment that was not available
for use and therefore, no depreciation has been recorded for such
laboratory equipment.
As at November 30,
2018, there was $Nil (November 30, 2017 - $75,005) unpaid balance
for purchased equipment. During the year ended November 30, 2018,
the Company recorded depreciation expense within cost of goods sold
of $2,352 (November 30, 2017 - $13,877; November 30, 2016 -
$Nil).
Property and
equipment are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying value of an asset may not
be recoverable. Impairment is assessed by comparing the carrying
amount of an asset with the sum of the undiscounted cash flows
expected from its use and disposal, and as such requires the
Company to make significant estimates on expected revenues from the
commercialization of its products and services and the related
expenses. The Company records a write-down for long-lived assets
which have been abandoned and do not have any residual value. For
the year ended November 30, 2018, the Company recorded a $Nil
write-down of long-lived assets (2017 - $Nil; 2016 –
$Nil).
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
|
|
|
|
|
|
|
|
|
Professional
fees
|
229,170
|
400,796
|
Property
taxes
|
-
|
111,970
|
Interest
|
17,413
|
54,110
|
Other
|
106,564
|
215,493
|
|
353,147
|
782,369
|
7.
Due
to related parties
Convertible debentures
Amounts due to the
related parties are payable to entities controlled by two
shareholders who are also officers and directors of the
Company.
|
|
|
|
|
|
Convertible
debenture payable to two directors and officers of the Company,
unsecured, 12% annual interest rate, Payable monthly (“2013
Debenture”)
|
$1,350,000
|
$1,290,465
|
Convertible
debenture payable to two directors and officers of the Company,
unsecured, 10% annual interest rate, Payable monthly (“2018
Debenture”)
|
$440,358
|
-
|
|
$1,790,358
|
$1,290,465
|
On January 10,
2013, the Company completed a private placement financing of the
unsecured convertible 2013 Debenture (as defined above) in the
original principal amount of $1.5 million, which had an original
maturity date of January 1, 2015. The 2013 Debenture bears interest
at a rate of 12% per annum, payable monthly, is pre-payable at any
time at the option of the Company and is convertible at any time
into common shares at a conversion price of $30.00 per common share
at the option of the holder.
Dr. Isa Odidi and
Dr. Amina Odidi, shareholders, directors and executive officers of
the Company purchased the 2013 Debenture and provided the Company
with the $1.5 million of the proceeds for the 2013
Debenture.
Effective October
1, 2014, the maturity date of the 2013 Debenture was extended to
July 1, 2015. Under ASC 470-50, the change in the debt instrument
was accounted for as a modification of debt. The increase in the
fair value of the conversion option at the date of the
modification, in the amount of $126,414, was recorded as a
reduction in the carrying value of the debt instrument with a
corresponding increase to Additional paid-in-capital. The carrying
amount of the debt instrument is accreted over the remaining life
of the 2013 Debenture using a 15% effective rate of
interest.
Effective June 29,
2015, the July 1, 2015 maturity date for the 2013 Debenture was
further extended to January 1, 2016. Under ASC 470-50, the change
in the maturity date of the debt instrument resulted in an
extinguishment of the original 2013 Debenture as the change in the
fair value of the embedded conversion option was greater than 10%
of the carrying amount of the 2013 Debenture. In accordance with
ASC 470-50-40, the 2013 Debenture was recorded at fair value. The
difference between the fair value of the convertible 2013 Debenture
after the extension and the net carrying value of the 2013
Debenture prior to the extension of $114,023 was recognized as a
loss on the statement of operations and comprehensive loss. The
carrying amount of the debt instrument was accreted to the face
amount of the 2013 Debenture over the remaining life of the 2013
Debenture using a 14.6% effective rate of interest.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
7.
Due
to related parties (continued)
Convertible debentures (continued)
Effective December
8, 2015, the January 1, 2016 maturity date of the 2013 Debenture
was extended to July 1, 2016. Under ASC 470-50, the change in the
debt instrument was accounted for as a modification of
debt.
The increase in the
fair value of the conversion option at the date of the
modification, in the amount of $83,101, was recorded as a reduction
in the carrying value of the debt instrument with a corresponding
increase to Additional paid-in-capital. The carrying amount of the
debt instrument is accreted over the remaining life of the 2013
Debenture using a 6.6% effective rate of interest.
Effective May 26,
2016, the July 1, 2016 maturity date of the 2013 Debenture was
extended to December 1, 2016. Under ASC 470-50, the change in the
debt instrument was accounted for as a modification of debt. The
increase in the fair value of the conversion option at the date of
the modification, in the amount of $19,808, was recorded as a
reduction in the carrying value of the debt instrument with a
corresponding increase to Additional paid-in-capital. The carrying
amount of the debt instrument was accreted over the remaining life
of the 2013 Debenture using a 4.2% effective rate of
interest.
Effective December
1, 2016, the maturity date of the 2013 Debenture was extended to
April 1, 2017 and a principal repayment of $150,000 was made at the
time of the extension. Under ASC 470-50, the change in the debt
instrument was accounted for as a modification of debt. The
increase in the fair value of the conversion option at the date of
the modification, in the amount of $106,962, was recorded as a
reduction in the carrying value of the debt instrument with a
corresponding increase to Additional paid-in-capital. The carrying
amount of the debt instrument is accreted over the remaining life
of the 2013 Debenture using a 26.3% effective rate of
interest.
Effective March 28,
2017, the maturity date of the 2013 Debenture was extended to
October 1, 2017. Under ASC 470-50, the change in the debt
instrument was accounted for as a modification of debt. The
increase in the fair value of the conversion option at the date of
the modification, in the amount of $113,607, was recorded as a
reduction in the carrying value of the debt instrument with a
corresponding increase to Additional paid-in-capital. The carrying
amount of the debt instrument is accreted over the remaining life
of the 2013 Debenture using a 15.2% effective rate of
interest.
Effective September
28, 2017, the maturity date of the 2013 Debenture was extended to
October 1, 2018. Under ASC 470-50, the change in the debt
instrument was accounted for as a modification of debt. The
increase in the fair value of the conversion option at the date of
the modification, in the amount of $53,227, was recorded as a
reduction in the carrying value of the debt instrument with a
corresponding increase to Additional paid-in-capital. The carrying
amount of the debt instrument is accreted over the remaining life
of the 2013 Debenture using a 4.9% effective rate of
interest.
Effective October
1, 2018, the maturity date for the 2013 Debenture was extended to
April 1, 2019. Under ASC 470-50, the change in the debt instrument
was accounted for as a modification of debt. There was no change in
the fair value of the conversion option at the date of the
modification. The carrying amount of the debt instrument is
accreted over the remaining life of the 2013 Debenture using a
nominal effective rate of interest.
On September 10,
2018, the Company completed a private placement financing of the
unsecured convertible 2018 Debenture (as defined above) in the
principal amount of $0.5 million. The 2018 Debenture will mature on
September 1, 2020. The 2018 Debenture bears interest at a rate of
10% per annum, payable monthly, is pre-payable at any time at the
option of the Company and is convertible at any time into common
shares of the Company at a conversion price of $3.00 per common
share at the option of the holder. Dr. Isa Odidi and Dr. Amina
Odidi, who are shareholders, directors and executive officers of
the Company provided the Company with the $0.5 million of the
proceeds for the 2018 Debenture.
At issuance, as the
conversion price was lower than the market share price, the
beneficial conversion feature valued at September 10, 2018 of
$66,667 was allocated to Additional paid-in capital. The fair value
of the 2018 Debenture will subsequently be accreted over the
remaining life of the 2018 Debenture using an effective rate of
interest of 7.3%.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
7.
Due
to related parties (continued)
Convertible debentures (continued)
Accreted interest
expense during the year ended November 30, 2018 is $66,560 (2017 -
$219,497; 2016 - $79,245), and has been included in the
consolidated statements of operations and comprehensive
loss.
In addition, the
coupon interest on the convertible debentures for the year ended
November 30, 2018 is $172,977 (2017 - $162,530; 2016 - $180,370),
and has also been included in the consolidated statements of
operations and comprehensive loss.
8.
Employee
costs payable
As at
November 30, 2018, the Company had $222,478 (2017 - $214,980)
accrued vacation payable to certain employees. This balance is due
on demand and therefore presented as current
liabilities.
On December 1,
2015, the Company entered into a new lease agreement for the
premises that it currently operates from, as well the adjoining
property which is owned by the same landlord, for a 5 year term
with a 5 year renewal option. The Company also has an option to
purchase the combined properties after March 1, 2017 and up to
November 30, 2020 based on a fair value purchase formula. Future
minimum lease payments under leases with terms of one year or more
are as follows at November 30, 2018:
|
|
|
|
|
|
|
|
2019
|
180,436
|
2020
|
180,436
|
|
360,872
|
Authorized, issued and outstanding
(a)
The Company is
authorized to issue an unlimited number of common shares, all
without nominal or par value and an unlimited number of preference
shares. As at November 30, 2018, the Company had 18,252,243
(November 30, 2017 – 3,470,451; November 30, 2016 –
2,978,999) common shares issued and outstanding and no preference
shares issued and outstanding. As of November 30, 2018, there were
1,030,000 common shares to be issued due to exercise of 2018
Pre-Funded Warrants (as defined below), which were issued
subsequently in December 2018.
Two officers and
directors of IPC owned directly and through their family holding
company (“Odidi Holdco”) 578,131 (2017 – 578,131)
common shares or approximately 3% (2017 – 17%) of
IPC.
Each common share
of the Company entitles the holder thereof to one vote at any
meeting of shareholders of the Company, except meetings at which
only holders of a specified class of shares are entitled to
vote.
Holders of common
shares of the Company are entitled to receive, as and when declared
by the board of directors of the Company, dividends in such amounts
as shall be determined by the board.
The holders of
common shares of the Company have the right to receive the
remaining property of the Company in the event of liquidation,
dissolution, or winding-up of the Company, whether voluntary or
involuntary.
The preference
shares may at any time and from time to time be issued in one or
more series. The board of directors will, by resolution, from time
to time, before the issue thereof, fix the rights, privileges,
restrictions and conditions attaching to the preference shares of
each series. Except as required by law, the holders of any series
of preference shares will not as such be entitled to receive notice
of, attend or vote at any meeting of the shareholders of the
Company. Holders of preference
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
10.
Capital
stock (continued)
Authorized, issued and outstanding (continued)
shares will be
entitled to preference with respect to payment of dividends and the
distribution of assets in the event of liquidation, dissolution or
winding-up of the Company, whether voluntary or involuntary, or any
other distribution of the assets of the Company among its
shareholders for the purpose of winding up its affairs, on such
shares over the common shares of the Company and over any other
shares ranking junior to the preference shares.
(b)
In November 2013,
the Company entered into an equity distribution agreement with Roth
Capital Partners, LLC (“Roth”), pursuant to which the
Company originally could from time to time sell up to 530,548 of
the Company’s common shares for up to an aggregate of $16.8
million (or such lesser amount as may then be permitted under
applicable exchange rules and securities laws and regulations)
through at-the-market issuances on Nasdaq or otherwise. Under the
equity distribution agreement, the Company was able at its
discretion, from time to time, offer and sell common shares through
Roth or directly to Roth for resale to the extent permitted under
Rule 415 under the Securities Act of 1933, as amended, at such time
and at such price as were acceptable to the Company, from time to
time, by means of ordinary brokers’ transactions on Nasdaq or
otherwise at market prices prevailing at the time of sale or as
determined by the Company. The Company has paid Roth a commission,
or allowed a discount, of 2.75% of the gross proceeds that the
Company received from any sales of common shares under the equity
distribution agreement. The Company also agreed to reimburse Roth
for certain expenses relating to the at-the-market offering
program.
During the year
ended November 30, 2018, an aggregate of Nil (2017 – 110,815;
2016 – 147,126) common shares were sold on Nasdaq for gross
proceeds of $Nil (2017- $2,541,640; 2016 - $3,469,449), with net
proceeds to the Company of $Nil (2017 - $2,468,474; 2016 -
$3,368,674), respectively, under the at-the-market offering
program. In March 2018, the Company terminated its continuous
offering under the prospectus supplement dated July 18, 2017 and
prospectus dated July 17, 2017 in respect of its at-the-market
program.
The underwriting
agreement relating to the October 2018 offering described in Note
10 restricts the Company’s ability to use this equity
distribution agreement. It contains a prohibition on the Company:
(i) for a period of two years following the date of the
underwriting agreement, from directly or indirectly in any
at-the-market or continuous equity transaction, offer to sell, or
otherwise dispose of shares of capital stock of the Company or any
securities convertible into or exercisable or exchangeable for its
shares of capital stock or (ii) for a period of five years
following the closing, effecting or entering into an agreement to
effect any issuance by the Company of common shares or common
shares equivalents involving a certain variable rate transactions
under an at-the-market offering agreement, whereby the Company may
issue securities at a future determined price, except that, on or
after the date that is two years after the closing, the Company may
enter into an at-the-market offering agreement.
(c)
Direct costs
related to the Company’s filing of a base shelf prospectus
filed in May 2014 and declared effective in June 2014, direct costs
related to the base shelf prospectus filed in May 2017 and certain
other on-going costs related to the at the-market facility are
recorded as deferred offering costs and are being amortized and
recorded as share issuance costs against share offerings. For the
year ended November 30, 2017, the Company recorded $137,363 as a
financing cost in the statements of operations and comprehensive
loss related to the base shelf prospectus filed in May 2014 and
expired in July 2017 and to the at-the-market facility. For the
year ended November 30, 2018, costs directly related to the at
the-market facility of $Nil (2017 - $73,166; 2016 - $100,775) were
recorded in share offering costs and $337,887 (2017 - $220,573;
2016 - $258,287) of deferred costs were amortized and recorded in
share offering costs related to the at the-market facility and base
shelf prospectus. For the year ended November 30, 2018, the Company
recorded $174,802 as a financing cost in the statements of
operations and comprehensive loss related to the at-the-market
offering program filed in November 2013.
(d)
In June 2016, the
Company completed an underwritten public offering of 322,981 units
of common shares and warrants, at a price of $16.10 per unit, as
further described in Note 14. The warrants are
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
10.
Capital
stock (continued)
Authorized, issued and outstanding (continued)
currently
exercisable, have a term of five years and an exercise price of
$19.30 per common share. The Company issued at the initial closing
of the offering an aggregate of 322,981 common shares and warrants
to purchase an additional 161,490 common shares. The underwriter
also purchased at such closing additional warrants at a purchase
price of $0.01 per warrant to acquire 24,223 common shares pursuant
to the over-allotment option exercised in part by the underwriter.
The Company subsequently sold an aggregate of 45,946 additional
common shares at the public offering price of $16.10 per share in
connection with subsequent partial exercises of the
underwriter’s over- allotment option. The closings of these
partial exercises brought the total net proceeds from the offering
to $5,137,638, after deducting the underwriter’s discount and
offering expenses. The warrants are considered to be indexed to the
Company’s own stock and are therefore classified as equity
under ASC topic 480 Distinguishing Liabilities from Equity. The
Company recorded $4,764,777 as the value of common shares under
Capital stock and $1,175,190 as the value of the warrants under
Additional paid-in-capital in the consolidated statements of
shareholders’ equity (deficiency). The Company has disclosed
the terms used to value the warrants in Note 14.
The direct costs
related to the issuance of these units of common shares and
warrants were $802,329 and were recorded as an offset against the
statement of shareholders’ equity (deficiency) with $643,593
being recorded under Capital stock and $158,736 being recorded
under Additional paid-in-capital.
(e)
In October 2017,
the Company completed a registered direct offering of 363,636
common shares at a price of $11.00 per share. The Company also
issued to the investors warrants to purchase an aggregate of
181,818 common shares (the “October 2017 Warrants”).
The warrants became exercisable six
months following the closing date, will expire 30 months after the
date they became exercisable, have a term of three years and
have an exercise price of $12.50 per common share. The Company also
issued to the placement agents warrants to purchase 18,181 common
shares at an exercise price of $13.75 per share (the “October
2017 Placement Agent Warrants”). The holders of October 2017
Warrants and October 2017 Placement Agent Warrants are entitled to
a cashless exercise under which the number of shares to be issued
will be based on the number of shares for which warrants are
exercised times the difference between the market price of the
common share and the exercise price divided by the market price.
The October 2017 Warrants and the October 2017 Placement Agent
Warrants are considered to be indexed to the Company’s own
stock and are therefore classified as equity under ASC topic 480
Distinguishing Liabilities from Equity.
The Company
recorded $3,257,445 as the value of common shares under Capital
stock and $742,555 as the value of the October 2017 Warrants under
Additional paid-in-capital in the consolidated statements of
shareholders’ equity (deficiency). The Company has disclosed
the terms used to value the warrants in Note 14.
The direct costs
related to the issuance of the common shares, October 2017 Warrants
and October 2017 Placement Agent Warrants were $500,492 and were
recorded as an offset against the statement of shareholders’
equity (deficiency) with $391,580 being recorded under Capital
stock and $108,912 being recorded under Additional
paid-in-capital.
(f)
In March 2018, the
Company completed two registered direct offerings of an aggregate
of 883,333 common shares at a price of $6.00 per share. The Company
also issued to the investors warrants to purchase an aggregate of
441,666 common shares (the “March 2018 Warrants”).
The warrants became exercisable six
months following the closing date, will expire 30 months after the
date they became exercisable, and have an exercise price of
$6.00 per common share. The Company also issued to the placement
agents warrants to purchase 44,166 common shares at an exercise
price of $7.50 per share (the “March 2018 Placement Agent
Warrants”). The holders of March 2018 Warrants and March 2018
Placement Agent Warrants are entitled to a cashless exercise under
which the number of shares to be issued will be based on the number
of shares for which warrants are exercised times the difference
between the market price of the common share and the exercise price
divided by the market price. The March 2018 Warrants and March 2018
Placement Agent Warrants are
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
10.
Capital
stock (continued)
Authorized, issued and outstanding (continued)
considered to be
indexed to the Company’s own stock and are therefore
classified as equity under ASC topic 480 Distinguishing Liabilities
from Equity.
The Company
recorded $4,184,520 as the value of common shares under Capital
stock and $1,115,480 as the value of the March 2018 Warrants under
Additional paid-in-capital in the consolidated statements of
shareholders’ equity (deficiency). The Company has disclosed
the terms used to value the warrants in Note 14.
The direct costs
related to the issuance of the common shares and warrants were
$831,357 including the cost of warrants issued to the placement
agents. These direct costs were recorded as an offset against the
statement of shareholders’ equity (deficiency) with $656,383
being recorded under Capital stock and $174,974 being recorded
under Additional paid-in-capital.
(g)
In October 2018,
the Company completed an underwritten public offering in the United
States, resulting in the sale to the public of 827,970 Units at
$0.75 per Unit, which are comprised of one common share and one
warrant (the “2018 Unit Warrants”) exercisable at $0.75
per share. The Company concurrently sold an additional 1,947,261
common shares and warrants to purchase 2,608,695 common shares
exercisable at $0.75 per share (the “2018 Option
Warrants’) pursuant to the over-allotment option exercised in
part by the underwriter. The price of the common shares issued in
connection with exercise of the over-allotment option was $0.74 per
share and the price for the warrants issued in connection with the
exercise of the over-allotment option was $0.01 per warrant, less
in each case the underwriting discount. In addition, the Company
issued 16,563,335 pre-funded units (“2018 Pre-Funded
Units’), each 2018 Pre-Funded Unit comprising of one
pre-funded warrant (a “2018 Pre-Funded Warrant”) to
purchase one common share and one warrant (a “2018
Warrant”, and together with the 2018 Unit Warrants and the
2018 Option Warrants, the “2018 Firm Warrants”) to
purchase one common share. The 2018 Pre-Funded Units were offered
to the public at $0.74 each and a 2018 Pre-Funded Warrant is
exercisable at $0.01 per share. Each 2018 Firm Warrant is
exercisable immediately and has a term of five years and each 2018
Pre-Funded Warrant is exercisable immediately and until all 2018
Pre-Funded Warrants are exercised. The Company also issued warrants
to the placement agents to purchase 1,160,314 common shares at an
exercise price of $0.9375 per share (the “October 2018
Placement Agent Warrants”), which were exercisable
immediately upon issuance. In aggregate, the Company issued
2,775,231 common shares, 16,563,335 2018 Pre-Funded Warrants and
20,000,000 2018 Firm Warrants in addition to 1,160,314 October 2018
Placement Agent Warrants.
The Company raised
$14,344,906 in gross proceeds as part of October 2018 underwritten
public offering. The Company recorded $1,808,952 as the value of
common shares under Capital stock and $279,086 as the value of the
2018 Firm Warrants and $12,256,868 as the value of the 2018
Pre-Funded Warrants under Additional paid-in-capital in the
consolidated statements of shareholders’ equity (deficiency).
During the year ended November 30, 2018, 12,153,334 2018 Pre-Funded
Warrants were exercised for proceeds of $121,553, and the Company
recorded a charge of $4,262,526 from Additional paid in capital to
common shares under Capital stock. The Company has disclosed the
terms used to value these warrants in Note 14.
As of November 30,
2018, there were 1,030,000 common shares to be issued due to
exercise of 2018 Pre-Funded Warrants; no other October 2018
Warrants had been exercised.
The direct costs
related to the issuance of the common shares and warrants issued in
October 2018 were $2,738,710 including the cost of October 2018
Placement Agent Warrants in the amount of $461,697. These direct
costs were recorded as an offset against the statement of
shareholders’ equity (deficiency) with $345,363 being
recorded under Capital stock and $2,393,347 being recorded under
Additional paid-in-capital.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
All
grants of options to employees after October 22, 2009 are made
from the Employee Stock Option Plan (the “Employee Stock
Option Plan”). The maximum number of common shares issuable
under the Employee Stock Option Plan is limited to 10% of the
issued and outstanding common shares of the Company from time to
time, or 1,825,224 based on the number of issued and outstanding
common shares as at November 30, 2018. As at November 30, 2018,
279,257 options are outstanding and there were 1,545,967 options
available for grant under the Employee Stock Option Plan. Each
option granted allows the holder to purchase one common share at an
exercise price not less than the closing price of the Company's
common shares on the TSX on the last trading day prior to the grant
of the option. Options granted under these plans typically have a
term of 5 years with a maximum term of 10 years and generally vest
over a period of up to three years.
In
August 2004, the Board of Directors of IPC Ltd. approved a grant of
276,394 performance-based stock options, to two executives who were
also the principal shareholders of IPC Ltd. The vesting of these
options is contingent upon the achievement of certain performance
milestones. A total of 276,394 performance-based stock options have
vested as of November 30, 2018. Under the terms of the
original agreement these
options were to expire in September 2014. Effective March 27, 2014,
the Company’s shareholders approved the two year extension of
the performance-based stock option expiry date to September 2016.
Effective April 19, 2016, the Company’s shareholders approved
a further two year extension of the performance-based stock option
expiry date to September 2018. As a result of the modification of
the performance-based stock option expiry date, the Company
recorded additional compensation costs of $1,177,782 related to
vested performance options during the year ended November 30, 2016.
Effective May 15, 2018, the Company’s shareholders approved a
further two year extension of the performance-based stock option
expiry date to September 2020. As a result of the modification of
the performance-based stock option expiry date, the Company
recorded additional compensation costs of $45,793 related to vested
performance options during the year ended November 30, 2018. These
options were outstanding as at November 30,
2018.
In
the year ended November 30, 2018, Nil (2017 – 37,600; 2016 -
35,500) stock options were granted to management and other
employees and Nil (2017 – 12,000; 2016 - 10,500) stock
options were granted to members of the Board of
Directors.
The
fair value of each option grant is estimated on the date of grant
using the Black-Scholes Option-Pricing Model, consistent with the
provisions of ASC topic 718. Option pricing models require the use
of subjective assumptions, changes in these assumptions can
materially affect the fair value of the options. The Company
calculates expected volatility based on historical volatility of
the Company’s peer group that is publicly traded for options
that have an expected life that is more than nine years. For
options that have an expected life of less than nine years the
Company uses its own volatility. The expected term, which
represents the period of time that options granted are expected to
be outstanding, is estimated based on the historical average of the
term and historical exercises of the options. The risk-free rate
assumed in valuing the options is based on the U.S. treasury yield
curve in effect at the time of grant for the expected term of the
option. The expected dividend yield percentage at the date of grant
is Nil as the Company is not expected to pay dividends in the
foreseeable future. The weighted average fair value of employee
stock options granted was estimated using the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
Volatility
|
-
|
71.7%
|
65.2%
|
Risk-free
interest rate
|
-
|
1.56%
|
0.620%
|
Expected
life (in years)
|
-
|
5.49
|
5.00
|
Dividend
yield
|
-
|
-
|
-
|
The
weighted average grant date
|
|
|
|
fair
value of options granted
|
-
|
$7.50
|
$12.00
|
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
Details of stock
option transactions in Canadian dollars (“C$”) are as
follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding,
|
|
|
|
|
|
|
|
|
|
beginning of
year
|
582,811
|
32.00
|
17.20
|
539,246
|
34.80
|
18.80
|
506,200
|
38.90
|
22.10
|
Granted
|
-
|
-
|
-
|
49,600
|
11.70
|
7.50
|
46,000
|
24.20
|
12.00
|
Exercised
|
-
|
-
|
-
|
(200)
|
23.20
|
12.00
|
(2,750)
|
25.70
|
16.80
|
Forfeiture
|
(25,533)
|
20.36
|
14.19
|
-
|
-
|
-
|
-
|
-
|
-
|
Expired
|
(1,627)
|
291.07
|
228.92
|
(5,835)
|
126.40
|
96.00
|
(10,204)
|
192.40
|
132.90
|
Balance,
|
|
|
|
|
|
|
|
|
|
end of
year
|
555,651
|
31.75
|
16.69
|
582,811
|
32.00
|
17.20
|
539,246
|
34.80
|
18.80
|
|
|
|
|
|
|
|
|
|
|
Options
|
|
|
|
|
|
|
|
|
|
exercisable,
|
|
|
|
|
|
|
|
|
|
end of
year
|
544,619
|
32.16
|
16.91
|
522,106
|
33.00
|
17.90
|
439,661
|
34.90
|
19.60
|
As of
November 30, 2018, the exercise prices, weighted average
remaining contractual life of outstanding options and weighted
average grant date fair values were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
|
|
|
|
|
|
|
|
price
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
109,067
|
17.99
|
2.66
|
9.75
|
98,035
|
14.14
|
10.15
|
26.00
- 50.00
|
446,584
|
35.11
|
1.98
|
29.25
|
446,584
|
35.11
|
29.25
|
|
555,651
|
31.75
|
|
|
544,619
|
32.16
|
|
Total unrecognized
compensation cost relating to the unvested performance-based stock
options at November 30, 2018 is approximately $Nil (2017 -
$788,887; 2016 - $2,366,659). During the year ended November 30,
2018, specific performance conditions were met as the FDA approved
one ANDA for certain drugs, resulting in the vesting of 27,640
performance-based stock options. As a result, a stock-based
compensation expense of $793,795 relating to these stock options
was recognized in research and development expense (2017 -
$1,577,772; 2016 - $620,632).
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
For the year ended
November 30, 2018, no options were exercised. For the year ended
November 30, 2017, 200 options were exercised for cash
consideration of $1,742. For the year ended November 30, 2016,
2,750 options were exercised for a cash consideration of
$52,868.
The following table
summarizes the components of stock-based compensation
expense.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
883,064
|
1,654,051
|
1,995,805
|
Selling,
general and administrative
|
44,622
|
95,948
|
265,639
|
|
927,686
|
1,749,999
|
2,261,444
|
The Company has
estimated its stock option forfeitures to be approximately 4% at
November 30, 2018 (2017 – 4%; 2016 – 4%).
Effective
May 28, 2010, the Company’s shareholders approved a
Deferred Share Unit (“DSU”) Plan to grant DSUs to its
non-management directors and reserved a maximum of 11,000 common
shares for issuance under the plan. The DSU Plan permits certain
non-management directors to defer receipt of all or a portion of
their board fees until termination of the board service and to
receive such fees in the form of common shares at that time. A DSU
is a unit equivalent in value to one common share of the Company
based on the trading price of the Company's common shares on the
TSX.
Upon termination of
board service, the director will be able to redeem DSUs based upon
the then market price of the Company's common shares on the date of
redemption in exchange for any combination of cash or common shares
as the Company may determine.
During the years
ended November 30, 2018 and 2017, one non-management board member
elected to receive director fees in the form of DSUs under the
Company’s DSU Plan. As at November 30, 2018, 10,279 (2017
– 9,413) DSUs are outstanding and 721 (2017 – 1,587)
DSUs are available for grant under the DSU Plan. The Company
recorded the following amounts related to DSUs for each of the
three years ended November 30, 2018, 2017 and 2016 in Additional
paid in capital and accrued the following amounts as at November
30, 2018, 2017 and 2016:
|
|
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
Additional
paid in capital
|
7,565
|
866
|
30,355
|
1,738
|
31,628
|
1,674
|
Accrued
liability
|
-
|
-
|
7,562
|
866
|
7,261
|
235
|
13.
Restricted
share units
Effective
May 28, 2010, the Company’s shareholders approved a
Restricted Share Unit (“RSU”) Plan for officers and
employees of the Company and reserved a maximum of 33,000 common
shares for issuance under the plan. The RSU Plan will form part of
the incentive compensation arrangements available to officers and
employees of the Company and its designated affiliates. An RSU is a
unit equivalent in value to one common share of the Company. Upon
vesting of the RSUs and the corresponding issuance of common shares
to the participant, or on the forfeiture and cancellation of the
RSUs, the RSUs credited to the participant’s account will be
cancelled. No RSUs have been issued under the plan.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
All of the
Company’s outstanding warrants are considered to be indexed
to the Company’s own stock and are therefore classified as
equity under ASC 480. The warrants, in specified situations,
provide for certain compensation remedies to a holder if the
Company fails to timely deliver the shares underlying the warrants
in accordance with the warrant terms.
In the registered
direct unit offering completed in March 2013, gross proceeds of
$3,121,800 were received through the sale of the Company’s
units comprised of common share and warrants.
The offering was
the sale of 181,500 units at a price of $17.20 per unit, with each
unit consisting of one common share and a five year warrant to
purchase 0.25 of a common share at an exercise price of $21.00 per
share (the “March 2013 Warrants”).
The fair value of
the March 2013 Warrants of $407,558 were initially estimated at
closing using the Black-Scholes Option Pricing Model, using
volatilities of 63%, risk free interest rates of 0.40%, expected
life of 5 years, and dividend yield of Nil. As at November 30,
2018, no March 2013 Warrants are outstanding.
In the underwritten
public offering completed in July 2013, gross proceeds of
$3,075,000 were received through the sale of the Company’s
units comprised of common shares and warrants. The offering was the
sale of 150,000 units at a price of $20.50 per unit, each unit
consisting of one common share and a five year warrant to purchase
0.25 of a common share at an exercise price of $25.50 per share
(the “July 2013 Warrants”). As at November 30, 2018, no
July 2013 Warrants are outstanding.
The fair value of
the July 2013 Warrants of $328,350 were initially estimated at
closing using the Black-Scholes Option Pricing Model, using
volatilities of 62.4%, risk free interest rates of 0.58%, expected
life of 5 years, and dividend yield of Nil.
In the underwritten
public offering completed in June 2016, gross proceeds of
$5,200,000 were received through the sale of the Company’s
units comprised of common shares and warrants. The Company issued
at the initial closing of the offering an aggregate of 322,981
common shares and warrants to purchase an additional 161,490 common
shares, at a price of $16.10 per unit. The warrants are currently
exercisable, have a term of five years and an exercise price of
$19.30 per common share. The underwriter also purchased at such
closing additional warrants (collectively with the warrants issued
at the initial closing, the “June 2016 Warrants”) at a
purchase price of $0.01 per warrant to acquire 24,223 common shares
pursuant to the over-allotment option exercised in part by the
underwriter. The fair value of the June 2016 Warrants of $1,175,190
was initially estimated at closing using the Black-Scholes Option
Pricing Model, using volatility of 64.1%, risk free interest rates
of 0.92%, expected life of 5 years, and dividend yield of Nil. The
June 2016 Warrants currently outstanding are detailed
below.
In the registered
direct offering completed in October 2017, gross proceeds of
$4,000,000 were received through the sale of the Company’s
common shares and warrants. The Company issued at the closing of
the offering an aggregate of 363,636 common shares at a price of
$11.00 per share and warrants to purchase an additional 181,818
common shares. The October 2017
Warrants became exercisable six months following the closing date,
will expire 30 months after the date they became
exercisable, and have an exercise price of $12.50 per common
share. The Company also issued the October 2017 Placement Agents
Warrants to purchase 18,181 common shares at an exercise price of
$13.75 per share. The holders of October 2017 Warrants and October
2017 Placement Agent Warrants are entitled to a cashless exercise
under which the number of shares to be issued will be based on the
number of share for which warrants are exercised times the
difference between the market price of the common share and the
exercise price divided by the market price. The fair value of the
October 2017 Warrants of $742,555 was initially estimated at
closing using the Black- Scholes Option Pricing Model, using
volatility of 73.67%, risk free interest rates of 1.64%, expected
life of 3 years, and dividend yield of Nil.
The fair value of
the October 2017 Placement Agents Warrants was estimated at $86,196
using the Black-Scholes Option Pricing Model, using volatility of
73.67%, a risk free interest rate of 1.64%, an expected life of 3
years, and a dividend yield of Nil.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
The October 2017
Warrants and the October 2017 Placement Agent Warrants currently
outstanding are detailed below.
In the two
registered direct offerings completed in March 2018, gross proceeds
of $5,300,000 were received through the sale of the Company’s
common shares and warrants. The Company issued at the closing of
the offering an aggregate of 883,333 common shares at a price of
$6.00 per share and the March 2018 Warrants to purchase an
additional 441,666 common shares. The
March 2018 Warrants became exercisable six months following the
closing date, will expire 30 months after the date they became
exercisable and have an exercise price of $6.00 per common
share. The Company also issued the March 2018 Placement Agent
Warrants to purchase 44,166 common shares at an exercise price of
$7.50 per share. The holders of March 2018 Warrants and March 2018
Placement Agent Warrants are entitled to a cashless exercise under
which the number of shares to be issued will be based on the number
of share for which warrants are exercised times the difference
between the market price of the common share and the exercise price
divided by the market price. The fair value of the March 2018
Warrants of $1,115,480 was initially estimated at closing using the
Black- Scholes Option Pricing Model, using volatility of 70%, risk
free interest rates of 2.44% and 2.46%, expected life of 3 years,
and dividend yield of Nil.
The fair value of
the March 2018 Placement Agent Warrants was estimated at $141,284
using the Black-Scholes Option Pricing Model, using volatility of
70%, risk free interest rates of 2.44% and 2.46%, an expected life
of 3 years, and a dividend yield of Nil. The March 2018 Warrants
and the March 2018 Placement Agent Warrants currently outstanding
are detailed below.
In October 2018,
the Company completed an underwritten public offering in the United
States, resulting in the sale to the public of 827,970 Units at
$0.75 per Unit, which are comprised of one common share and one
2018 Unit Warrant (as defined above) exercisable at $0.75 per
share. The Company concurrently sold an additional 1,947,261 common
shares and 2,608,695 2018 Option Warrants exercisable at $0.75 per
share pursuant to the over-allotment option exercised in part by
the underwriter. The price of the common shares issued in
connection with exercise of the over-allotment option was $0.74 per
share and the price for the warrants issued in connection with the
exercise of the over-allotment option was $0.01 per warrant, less
in each case the underwriting discount. In addition, the Company
issued 16,563,335 2018 Pre-Funded Units (as defined above), each
2018 Pre-Funded Unit consisting of one 2018 Pre-Funded Warrant (as
defined above) to purchase one common share and one 2018 Warrant
(as defined above) to purchase one common share. The 2018
Pre-Funded Units were offered to the public at $0.74 each and a
2018 Pre-Funded Warrant is exercisable at $0.01 per share. Each
2018 Firm Warrant is exercisable immediately and has a term of five
years and each 2018 Pre-Funded Warrant is exercisable
immediately and
until all 2018 Pre-Funded Warrants are exercised. The Company also
issued the October 2018 Placement Agent Warrants to the placement
agents to purchase 1,160,314 common shares at an exercise price of
$0.9375 per share, which were exercisable immediately upon
issuance. In aggregate, in October 2018, the Company issued
2,775,231 common shares, 16,563,335 2018 Pre-Funded Warrants and
20,000,000 2018 Firm Warrants in addition to 1,160,314 October 2018
Placement Agent Warrants.
The fair value of
the 2018 Firm Warrants of $279,086 was initially estimated at
closing using the Black-Scholes Option Pricing Model, using
volatility of 92%, risk free interest rates of 3.02%, expected life
of 5 years, and dividend yield of Nil. The fair value of the
October 2018 Placement Agents Warrants was estimated at $461,697
using the Black-Scholes Option Pricing Model, using volatility of
92%, risk free interest rates of 3.02%, an expected life of 5
years, and a dividend yield of Nil.
The fair value of
the 2018 Pre-Funded Warrant of $12,256,868 and the fair value of
the 2018 Firm Warrants of $279,086, respectively, were recorded
under Additional paid-in-capital in the consolidated statements of
shareholders’ equity (deficiency).
During the year
ended November 30, 2018, 12,153,334 2018 Pre-Funded Warrants were
exercised for proceeds of $121,553, and the Company recorded a
charge of $4,262,526 from Additional paid-in-capital to common
shares under Capital stock.
As at November 30,
2018, 4,410,001 2018 Pre-Funded Warrants are outstanding which are
exercisable immediately at $0.01 per share. In addition, the
following table provides information on the 22,123,623 warrants
including 2018 Firm Warrants outstanding and exercisable as of
November 30, 2018:
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
|
|
|
|
Shares
issuable
|
Warrant
|
Exercise
price
|
Number
outstanding
|
Expiry
|
upon
exercise
|
|
|
|
|
|
June
2016 Warrants
|
$19.30
|
277,478
|
June
2, 2021
|
138,739
|
October
2017 Warrants
|
$12.50
|
181,818
|
October
13, 2020
|
181,818
|
October
2017 Placement
|
|
|
|
|
Agent
Warrants
|
$13.750
|
18,181
|
October
13, 2020
|
18,181
|
March
2018 Warrants
|
$6.00
|
291,666
|
March
16, 2021
|
291,666
|
March
2018 Warrants
|
$6.00
|
150,000
|
March
21, 2021
|
150,000
|
March
2018 Placement
|
|
|
|
|
Agent
Warrants
|
$7.50
|
29,166
|
March
16, 2021
|
29,166
|
March
2018 Placement
|
|
|
|
|
Agent
Warrants
|
$7.50
|
15,000
|
March
21, 2021
|
15,000
|
2018
Firm Warrants
|
$0.75
|
20,000,000
|
October
16, 2023
|
20,000,000
|
2018
Pre-Funded Warrants
|
$0.01
|
4,410,001
|
October
16, 2023
|
4,410,001
|
October
2018 Placement
|
|
|
|
|
Agent
Warrants
|
$0.9375
|
1,160,314
|
October
16, 2023
|
1,160,314
|
|
|
26,533,624
|
|
26,394,885
|
During the year
ended November 30, 2018, other than Pre-Funded Warrants as noted
above, there were no cash exercises in respect of warrants (2017
– 33,602; 2016 – 83,210) and no cashless exercise (2017
- Nil; 2016 - Nil) of warrants, resulting in the issuance of Nil
(2017 – 16,801; 2016 – 35,791) and Nil (2017 - Nil;
2016 - Nil) common shares, respectively. For the warrants
exercised, the Company recorded a charge to capital stock of $Nil
(2017 - $430,573; 2016 - $1,030,719) comprised of proceeds of $Nil
(2017 - $324,258; 2016 - $700,653) and the associated amount of
$Nil (2017 - $106,315; 2016 - $330,066) previously recorded in
Additional paid-in-capital.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
Details of warrant
transactions for the years ended November 30, 2018 and 2017 are as
follows:
|
Outstanding,
December
1, 2017
|
|
|
|
Rounding
on consolidation
|
Outstanding,
November
30, 2018
|
March
2013 Warrants
|
149,174
|
-
|
(149,174)
|
-
|
-
|
-
|
July
2013 Warrants
|
87,000
|
-
|
(87,000)
|
-
|
-
|
-
|
June
2016 Warrants
|
277,872
|
-
|
-
|
-
|
(394)
|
277,478
|
October
2017 Warrants
|
181,818
|
-
|
-
|
-
|
-
|
181,818
|
October
2017 Placement
|
|
|
|
|
|
|
Agent
Warrants
|
18,181
|
-
|
-
|
-
|
-
|
18,181
|
March
2018 Warrants
|
-
|
441,666
|
-
|
-
|
-
|
441,666
|
March
2018 Placement
|
|
|
|
|
|
|
Agent
Warrants
|
-
|
44,166
|
-
|
-
|
-
|
44,166
|
2018
Firm Warrants
|
-
|
20,000,000
|
-
|
-
|
-
|
20,000,000
|
2018
Pre-Funded Warrants
|
-
|
16,563,335
|
-
|
(12,153,334)
|
-
|
4,410,001
|
October
2018 Placement
|
|
|
|
|
|
|
Agent
Warrants
|
-
|
1,160,314
|
-
|
-
|
-
|
1,160,314
|
|
714,045
|
38,209,481
|
(236,174)
|
(12,153,334)
|
(394)
|
26,533,624
|
|
|
|
|
|
October 2017
Placement Agent Warrants
|
|
Outstanding,
December 1, 2016
|
149,174
|
87,000
|
311,474
|
-
|
-
|
547,648
|
Issued
|
-
|
-
|
-
|
181,818
|
18,181
|
199,999
|
Exercised
|
-
|
-
|
(33,602)
|
-
|
-
|
(33,602)
|
Outstanding,
November 30, 2017
|
149,174
|
87,000
|
277,872
|
181,818
|
18,181
|
714,045
|
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
The Company files
Canadian income tax returns for its Canadian operations. Separate
income tax returns are filed as locally required.
The total provision
for income taxes differs from the amount which would be computed by
applying the Canadian income tax rate to loss before income taxes.
The reasons for these differences are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statutory
income tax rate
|
26.5
|
26.5
|
26.5
|
|
|
|
|
|
$
|
$
|
$
|
|
|
|
|
Statutory
income tax recovery
|
(3,643,080)
|
(2,347,222)
|
(2,688,048)
|
Increase
(decrease) in income taxes
|
|
|
|
Non-deductible
expenses/
|
|
|
|
non-taxable
income
|
263,650
|
488,769
|
640,481
|
Change
in valuation allowance
|
4,861,770
|
2,128,819
|
2,683,775
|
Investment
tax credit
|
(466,052)
|
-
|
-
|
Financing
costs booked to equity
|
(1,049,430)
|
(269,715)
|
(281,063)
|
Difference
in foreign tax rates
|
290
|
(651)
|
-
|
True
up of tax returns
|
11,029
|
-
|
(356,095)
|
Tax
loss expired and other
|
21,823
|
-
|
950
|
|
-
|
-
|
-
|
The Company
recognizes deferred tax assets and liabilities for the expected
future tax consequences of temporary differences between the
carrying amounts and the tax basis of assets and liabilities and
certain carry-forward balances. Significant temporary differences
and carry-forwards are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax assets
|
|
|
|
Non-capital
loss carry-forwards
|
11,847,710
|
8,972,285
|
7,427,516
|
Book
and tax basis differences
|
|
|
|
on
assets and liabilities
|
1,041,360
|
863,215
|
3,409,343
|
Other
|
2,586,070
|
2,681,375
|
-
|
Investment
tax credit
|
3,354,760
|
2,865,404
|
2,405,365
|
Undeducted
research and
|
|
|
|
development
expenditures
|
4,870,130
|
4,158,178
|
3,710,274
|
Capital
loss carryforwards
|
326,060
|
326,064
|
-
|
Share
issuance cost
|
1,152,750
|
436,427
|
-
|
Net
operating loss carryforwards
|
-
|
14,135
|
-
|
|
25,178,840
|
20,317,083
|
16,952,498
|
Valuation
allowances for
|
|
|
|
deferred
tax assets
|
(25,178,840)
|
(20,317,083)
|
(16,952,498)
|
Net
deferred tax assets
|
-
|
-
|
-
|
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
15.
Income
taxes (continued)
At
November 30, 2018, the Company had cumulative operating losses
available to reduce future years’ income for income tax
purposes:
Canadian
income tax losses expiring
|
|
in
the year ended November 30,
|
|
|
|
|
|
2028
|
182,222
|
2029
|
555,539
|
2030
|
3,373,079
|
2031
|
5,532,739
|
2032
|
5,750,053
|
2033
|
4,562,538
|
2034
|
149,927
|
2035
|
2,634,823
|
2036
|
5,341,606
|
2037
|
5,694,760
|
2038
|
10,931,052
|
|
44,708,338
|
At
November 30, 2018, the Company had a cumulative carry-forward
pool of Canadian Federal SR&ED expenditures in the amount of
approximately $18,377,849 (2017 - $15,690,203) which can be carried
forward indefinitely.
At
November 30, 2018, the Company had approximately $3,483,828
(2017 - $2,976,546) of unclaimed ITCs which expire from 2025 to
2038. These credits are subject to a full valuation allowance as
they are not more likely than not to be realized.
The net deferred
tax assets have been fully offset by a valuation allowance because
it is not more likely than not the Company will realize the benefit
of these deferred tax assets. The Company does not have any
recognized tax benefits as of November 30, 2018 or
November 30, 2017.
The Company files
unconsolidated federal income tax returns domestically and in
foreign jurisdictions. The Company has open tax years from 2009 to
2018 with tax jurisdictions including Canada and the U.S. These
open years contain certain matters that could be subject to
differing interpretations of applicable tax laws and regulations,
as they relate to amount, timing, or inclusion of revenues and
expenses.
The Company did not
incur any interest expense related to uncertain tax positions in
2018, 2017 and 2016 or any penalties in those years. The Company
had no accrued interest and penalties as of November 30, 2018,
2017 and 2016.
The Company had no
unrecognized tax benefits in 2018, 2017 and 2016, and the Company
does not expect that the unrecognized tax benefit will increase
within the next twelve months.
From
time to time, the Company may be exposed to claims and legal
actions in the normal course of business. As at November 30, 2018,
and continuing as at February 22, 2019, the Company is not aware of
any pending or threatened material litigation claims against the
Company, other than as described below.
In
November 2016, the Company filed an NDA for its abuse-deterrent
oxycodone hydrochloride extended release tablets (formerly referred
to as RexistaTM) (“Oxycodone ER”) product candidate,
relying on the 505(b)(2) regulatory pathway, which allowed the
Company to reference data from Purdue Pharma L.P.'s file for its
OxyContin® extended release oxycodone hydrochloride. The
Oxycodone ER application was accepted by the FDA for further review
in February 2017. The Company certified to the FDA that it believed
its Oxycodone ER product candidate would not infringe any of the
OxyContin® patents listed in the Orange Book, or that such
patents are invalid, and so notified Purdue Pharma L.P. and the
other owners of the subject patents listed in the Orange Book of
such certification. On April 7, 2017, the Company had received
notice that Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The
P.F. Laboratories, Inc., or collectively
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
16.
Contingencies (continued)
the
Purdue parties, Rhodes Technologies, and Grünenthal GmbH, or
collectively the Purdue litigation plaintiffs, had commenced patent
infringement proceedings against the Company in the U.S. District
Court for the District of Delaware (docket number 17-392) in
respect of the Company’s NDA filing for Oxycodone ER,
alleging that its proposed Oxycodone ER infringes 6 out of the 16
patents associated with the branded product OxyContin®, or the
OxyContin® patents, listed in the Orange Book. The complaint
seeks injunctive relief as well as attorneys' fees and costs and
such other and further relief as the Court may deem just and
proper. An answer and counterclaim have been filed.
Subsequent
to the above-noted filing of lawsuit, 4 further such patents were
listed and published in the Orange Book. The Company then similarly
certified to the FDA concerning such further patents. On March 16,
2018, the Company received notice that the Purdue litigation
plaintiffs had commenced further such patent infringement
proceedings against the Company adding the 4 further patents. This
lawsuit is also in the District of Delaware federal court under
docket number 18-404.
As
a result of the commencement of the first of these legal
proceedings, the FDA is stayed for 30 months from granting final
approval to the Company’s Oxycodone ER product candidate.
That time period commenced on February 24, 2017, when the Purdue
litigation plaintiffs received notice of the Company’s
certification concerning the patents, and will expire on August 24,
2019, unless the stay is earlier terminated by a final declaration
of the courts that the patents are invalid, or are not infringed,
or the matter is otherwise settled among the parties.
On
or about June 26, 2018 the court issued an order to sever 6
overlapping patents from the second Purdue case, but ordered
litigation to proceed on the 4 new (2017-issued) patents. An answer
and counterclaim was filed July 9, 2018. The existence and
publication of additional patents in the Orange Book, and
litigation arising therefrom, is an ordinary and to be expected
occurrence in the course of such litigation.
On
July 6, 2018 the court issued a so-called “Markman”
claim construction ruling on the first case and the October 22,
2018 trial date remained unchanged. The Company believes that it
has non-infringement and/or invalidity defenses to all of the
asserted claims of the subject patents in both of the cases and
will vigorously defend against these claims.
On
July 24, 2018, the parties to the case mutually agreed to and did
have dismissed without prejudice the infringement claims related to
the Grünenthal ‘060 patent. The Grünenthal
‘060 patent is one of the six patents included in the
original litigation case, however, the dismissal does not by itself
result in a termination of the 30-month litigation
stay.
On
October 4, 2018, the parties mutually agreed to postpone the
scheduled court date pending a case status conference scheduled for
December 17, 2018. At that time, further trial scheduling and other
administrative matters were postponed pending the Company’s
anticipated resubmission of the Oxycodone ER NDA to the FDA, which
is due no later than February 28, 2019.
In July 2017, three
complaints were filed in the U.S. District Court for the Southern
District of New York that were later consolidated under the caption
Shanawaz v. Intellipharmaceutics Int’l Inc., et al., No.
1:17-cv-05761 (S.D.N.Y.). The lead plaintiffs filed a consolidated
amended complaint on January 29, 2018. In the amended complaint,
the lead plaintiffs assert claims on behalf of a putative class
consisting of purchasers of the Company’s securities between
May 21, 2015 and July 26, 2017. The amended complaint alleges that
the defendants violated Sections 10(b) and 20(a) of the Securities
Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by
making allegedly false and misleading statements or failing to
disclose certain information regarding the Company’s NDA for
Oxycodone ER abuse-deterrent oxycodone hydrochloride extended
release tablets. The complaint seeks, among other remedies,
unspecified damages, attorneys’ fees and other costs,
equitable and/or injunctive relief, and such other relief as the
court may find just and proper.
On March 30, 2018,
the Company and the other defendants filed a motion to dismiss the
amended complaint for failure to state a valid claim. The
defendants’ motion to dismiss was granted in part, and denied
in part, in an Order dated December 17, 2018. In its Order, the
court dismissed certain of the plaintiffs’ securities claims
to the extent that the claims were based upon statements describing
the Oxycodone ER product’s abuse-deterrent features and its
bioequivalence to OxyContin. However, the court allowed the claims
to proceed to the extent plaintiffs challenged certain public
statements describing the contents of the Company’s Oxycodone
ER NDA. Defendants filed an answer to the amended complaint
on January 7, 2019, and discovery is ongoing. The Company and
the other defendants intend to vigorously defend themselves against
the remainder of the claims asserted in the consolidated
action.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
16.
Contingencies (continued)
On February 21,
2019, the Company and its CEO, Dr. Isa Odidi, received a Statement
of Claim concerning an action against them in the Superior Court of
Justice of Ontario under the caption Victor Romita, plaintiff, and
Intellipharmaceutics International Inc and Isa Odidi, defendants.
The action seeks certification as a class action and alleges that
certain public statements made by the Company in the period
February 29, 2016 to July 26, 2017 knowingly or negligently
contained or omitted material facts concerning the Company’s
NDA for Oxycodone ER abuse-deterrent oxycodone hydrochloride
extended release tablets. The plaintiff alleges that he suffered
loss and damages as a result of trading in the Company’s
shares on the Toronto Stock Exchange during the above-noted period.
The claim seeks, among other remedies, unspecified damages, legal
fees and court and other costs as the court may permit. At this
time, the action has not been certified as a class action. The
Company intends to vigorously defend against the claims asserted in
this action.
17.
Financial
instruments
The Company follows
ASC topic 820, “Fair Value Measurements” which defines
fair value, establishes a framework for measuring fair value, and
expands disclosures about fair value measurements. The provisions
of ASC topic 820 apply to other accounting pronouncements that
require or permit fair value measurements. ASC topic 820 defines
fair value as the exchange price that would be received for an
asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in
an orderly transaction between market participants at the
measurement date; and establishes a three level hierarchy for fair
value measurements based upon the transparency of inputs to the
valuation of an asset or liability as of the measurement
date.
Inputs refers
broadly to the assumptions that market participants would use in
pricing the asset or liability, including assumptions about risk.
To increase consistency and comparability in fair value
measurements and related disclosures, the fair value hierarchy
prioritizes the inputs to valuation techniques used to measure fair
value into three broad levels. The three levels of the hierarchy
are defined as follows:
Level 1 inputs are
quoted prices (unadjusted) in active markets for identical assets
or liabilities.
Level 2 inputs are
inputs other than quoted prices included within Level 1 that are
observable for the asset or liability, either directly or
indirectly for substantially the full term of the financial
instrument.
Level 3 inputs are
unobservable inputs for asset or liabilities.
The categorization
within the valuation hierarchy is based upon the lowest level of
input that is significant to the fair value
measurement.
(i)
The Company
calculates expected volatility based on historical volatility of
the Company’s peer group that is publicly traded for options
that have an expected life that is more than eight years (Level 2)
while the Company uses its own historical volatility for options
that have an expected life of eight years or less (Level
1).
(ii)
The Company
calculates the interest rate for the conversion option based on the
Company’s estimated cost of raising capital (Level
2).
An
increase/decrease in the volatility and/or a decrease/increase in
the discount rate would have resulted in an increase/decrease in
the fair value of the conversion option and warrants.
Fair value of
financial assets and financial liabilities that are not measured at
fair value on a recurring basis are as follows:
|
November 30, 2018
|
November 30, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
Liabilities
|
|
|
|
|
Convertible debentures(i)
|
1,790,358
|
1,795,796
|
1,290,465
|
1,316,386
|
(i)
The Company
calculates the interest rate for the convertible debentures and due
to related parties based on the Company’s estimated cost of
raising capital and uses the discounted cash flow model to
calculate the fair value of the convertible debentures and the
amounts due to related parties.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
17.
Financial
instruments (continued)
(a)
Fair
values (continued)
The carrying values
of cash, accounts receivable, accounts payable, accrued liabilities
and employee cost payable approximates their fair values because of
the short-term nature of these instruments.
(b)
Interest rate and credit risk
Interest rate risk
is the risk that the value of a financial instrument might be
adversely affected by a change in interest rates. The Company does
not believe that the results of operations or cash flows would be
affected to any significant degree by a sudden change in market
interest rates, relative to interest rates on cash and the
convertible debenture due to the short-term nature of these
obligations.
Trade accounts
receivable potentially subjects the Company to credit risk. The
Company provides an allowance for doubtful accounts equal to the
estimated losses expected to be incurred in the collection of
accounts receivable.
The following table
sets forth details of the aged accounts receivable that are not
overdue as well as an analysis of overdue amounts and the related
allowance for doubtful accounts:
|
|
|
|
|
|
|
|
|
|
|
|
Total
accounts receivable
|
305,912
|
756,468
|
Less
allowance for doubtful accounts
|
(66,849)
|
(66,849)
|
Total
accounts receivable, net
|
239,063
|
689,619
|
|
|
|
Not
past due
|
239,063
|
689,619
|
Past
due for more than 31 days
|
|
|
but
no more than 120 days
|
-
|
5,176
|
Past
due for more than 120 days
|
66,849
|
61,673
|
Total
accounts receivable, gross
|
305,912
|
756,468
|
Financial
instruments that potentially subject the Company to concentration
of credit risk consist principally of uncollateralized accounts
receivable. The Company’s maximum exposure to credit risk is
equal to the potential amount of financial assets. For the year
ended November 30, 2018 and 2017, two customers accounted for
substantially all the revenue and all the accounts receivable of
the Company.
The Company is also
exposed to credit risk at period end from the carrying value of its
cash. The Company manages this risk by maintaining bank accounts
with a Canadian Chartered Bank. The Company’s cash is not
subject to any external restrictions.
(c)
Foreign exchange risk
The Company has
balances in Canadian dollars that give rise to exposure to foreign
exchange (“FX”) risk relating to the impact of
translating certain non-U.S. dollar balance sheet accounts as these
statements are presented in U.S. dollars. A strengthening U.S.
dollar will lead to a FX loss while a weakening U.S. dollar will
lead to a FX gain. For each Canadian dollar balance of
$1.0 million, a +/- 10% movement in the Canadian currency held
by the Company versus the U.S. dollar would affect the
Company’s loss and other comprehensive loss by
$0.1 million.
Intellipharmaceutics
International Inc.
Notes to the
consolidated financial statements
November 30, 2018,
2017 and 2016
(Stated in U.S.
dollars)
17.
Financial
instruments (continued)
Liquidity risk is
the risk that the Company will encounter difficulty raising liquid
funds to meet commitments as they fall due. In meeting its
liquidity requirements, the Company closely monitors its forecasted
cash requirements with expected cash drawdown.
The following are
the contractual maturities of the undiscounted cash flows of
financial liabilities as at November 30, 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third
parties
|
|
|
|
|
|
|
Accounts
payable
|
2,643,437
|
-
|
-
|
-
|
-
|
2,643,437
|
Accrued
liabilities
|
353,147
|
-
|
-
|
-
|
-
|
353,147
|
Related
parties
|
|
|
|
|
|
|
Employee
costs payable
|
222,478
|
-
|
-
|
-
|
-
|
222,478
|
Convertible
debentures (Note 7)
|
52,274
|
1,376,805
|
12,603
|
12,466
|
537,808
|
1,991,956
|
|
3,271,336
|
1,376,805
|
12,603
|
12,466
|
537,808
|
5,211,018
|
18.
Segmented
information
The Company's
operations comprise a single reportable segment engaged in the
research, development and manufacture of novel and generic
controlled-release and targeted-release oral solid dosage drugs. As
the operations comprise a single reportable segment, amounts
disclosed in the financial statements for revenue, loss for the
period, depreciation and total assets also represent segmented
amounts. In addition, all of the Company's long-lived assets are in
Canada. The Company’s license and commercialization agreement
with Par accounts for substantially all of the revenue of the
Company.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
United
States
|
1,712,731
|
5,504,452
|
2,247,002
|
|
1,712,731
|
5,504,452
|
2,247,002
|
|
|
|
|
Total
assets
|
|
|
|
Canada
|
11,474,227
|
7,396,781
|
7,974,689
|
|
|
|
|
Total
property and equipment
|
|
|
|
Canada
|
2,755,993
|
3,267,551
|
1,889,638
|
In
December 2018, a principal repayment of $300,000 was made for the
2013 Debenture to Drs. Isa and Amina Odidi.