Blueprint
Filed pursuant to Rule 424(b)(3)
Registration No. 333-226239
PROSPECTUS SUPPLEMENT NO. 8
(To
Prospectus dated August 8, 2018)
INTELLIPHARMACEUTICS INTERNATIONAL INC.
6,858,334 Common Shares
This
Prospectus Supplement No. 8 (this “Prospectus Supplement”) amends and supplements our
Prospectus dated August 8, 2018, as supplemented by prospectus
supplement no. 1, dated August 15, 2018, as supplemented by
prospectus supplement no. 2, dated September 11, 2018, as
supplemented by prospectus supplement no. 3, dated September 13,
2018, as supplemented by prospectus supplement no. 4, dated October
1, 2018, as supplemented by prospectus supplement no. 5, dated
October 5, 2018, as supplemented by prospectus supplement no. 6,
dated October 11, 2018, and as supplemented by prospectus
supplement no. 7, dated October 15, 2018 (the “Prospectus”), which form a part of our
Registration Statement (our “Registration Statement”) on Form F-1 (Registration No.
333-226239). This Prospectus Supplement is being filed to 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 resale, from time to time, of up to 6,858,334 common shares by
certain of our shareholders identified in the
Prospectus.
This
Prospectus Supplement includes information from our Report on Form
6-K, which was filed with the Securities and Exchange Commission on
October 15, 2018.
This
Prospectus Supplement should be read in conjunction with the
Prospectus that was previously filed, 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 IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
_______________
The
date of this Prospectus Supplement is October 15, 2018
Intellipharmaceutics
International
Inc.
August 31,
2018
Intellipharmaceutics
International Inc.
August 31,
2018
Table of
contents
Condensed unaudited
interim consolidated balance sheets
|
2
|
Condensed unaudited
interim consolidated statements of operations and comprehensive
loss
|
3
|
Condensed unaudited
interim consolidated statements of shareholders’ equity
(deficiency)
|
4
|
Condensed unaudited
interim consolidated statements of cash flows
|
5
|
Notes to the
condensed unaudited interim consolidated financial
statements
|
6-24
|
Intellipharmaceutics International Inc.
|
|
|
Condensed
unaudited interim consolidated balance sheets
|
|
|
As
at
|
|
|
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
$
|
$
|
Assets
|
|
|
Current
|
|
|
Cash
|
57,388
|
1,897,061
|
Accounts
receivable, net
|
263,340
|
689,619
|
Investment
tax credits
|
771,490
|
636,489
|
Prepaid
expenses, sundry and other assets
|
566,638
|
225,092
|
Inventory
(Note 3)
|
250,322
|
115,667
|
|
1,909,178
|
3,563,928
|
|
|
|
Deferred
offering costs (Note 6)
|
814,881
|
565,302
|
Property
and equipment, net (Note 4)
|
2,909,927
|
3,267,551
|
|
5,633,986
|
7,396,781
|
|
|
|
Liabilities
|
|
|
Current
|
|
|
Accounts
payable
|
5,857,726
|
2,060,084
|
Accrued
liabilities
|
741,875
|
782,369
|
Employee
costs payable
|
216,926
|
214,980
|
Convertible
debenture (Note 5)
|
1,338,975
|
1,290,465
|
Deferred
revenue (Note 3)
|
300,000
|
300,000
|
|
8,455,502
|
4,647,898
|
|
|
|
Deferred
revenue (Note 3)
|
2,137,500
|
2,362,500
|
|
10,593,002
|
7,010,398
|
|
|
|
Shareholders' (deficiency)/equity
|
|
|
Capital
stock (Note 6,7 and 9)
|
|
|
Authorized
|
|
|
Unlimited
common shares without par value
|
|
|
Unlimited
preference shares
|
|
|
Issued
and outstanding
|
|
|
4,353,678
common shares
|
38,697,900
|
35,290,034
|
(November
30, 2017 - 3,470,451)
|
|
|
Additional
paid-in capital
|
37,895,090
|
36,685,387
|
Accumulated
other comprehensive income
|
284,421
|
284,421
|
Accumulated
deficit
|
(81,836,427)
|
(71,873,459)
|
|
(4,959,016)
|
386,383
|
Contingencies
(Note 11)
|
|
|
|
5,633,986
|
7,396,781
|
|
|
|
See
accompanying notes to condensed unaudited interim consolidated
financial statements
|
Intellipharmaceutics International Inc.
|
|
|
|
|
Condensed
unaudited interim consolidated statements of operations and
comprehensive loss
|
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
Revenue
|
|
|
|
|
Licensing
(Note 3)
|
320,330
|
1,114,739
|
1,062,597
|
4,201,617
|
Up-front
fees (Note 3)
|
93,225
|
75,000
|
262,443
|
225,000
|
|
413,555
|
1,189,739
|
1,325,040
|
4,426,617
|
|
|
|
|
|
Cost of good sold
|
|
|
|
|
Cost
of goods sold
|
45,299
|
376,054
|
111,173
|
587,426
|
Gross Margin
|
368,256
|
813,685
|
1,213,867
|
3,839,191
|
|
|
|
|
|
Expenses
|
|
|
|
|
Research
and development
|
3,324,221
|
2,298,804
|
7,783,549
|
7,007,503
|
Selling,
general and administrative
|
792,379
|
756,635
|
2,773,698
|
2,468,436
|
Depreciation
|
155,288
|
126,316
|
457,314
|
331,102
|
|
4,271,888
|
3,181,755
|
11,014,561
|
9,807,041
|
|
|
|
|
|
Loss
from operations
|
(3,903,632)
|
(2,368,070)
|
(9,800,694)
|
(5,967,850)
|
|
|
|
|
|
Net
foreign exchange gain (loss)
|
9,406
|
(90,875)
|
17,106
|
(73,569)
|
Interest
income
|
8
|
5
|
22
|
15,030
|
Interest
expense
|
(59,886)
|
(91,374)
|
(179,402)
|
(320,115)
|
Net
loss and comprehensive loss
|
(3,954,104)
|
(2,550,314)
|
(9,962,968)
|
(6,346,504)
|
|
|
|
|
|
Loss
per common share, basic and diluted
|
(0.91)
|
(0.83)
|
(2.49)
|
(2.09)
|
|
|
|
|
|
Weighted average number of common
|
|
|
|
|
shares outstanding, basic and diluted
|
4,353,678
|
3,071,378
|
4,006,582
|
3,035,906
|
|
|
|
|
|
See
accompanying notes to condensed unaudited interim consolidated
financial statements
|
Intellipharmaceutics International Inc.
|
|
|
|
|
|
|
Condensed
unaudited interim consolidated statements of shareholders' equity
(deficiency)
|
for the
nine months ended August 31, 2018 and August 31,
2017
|
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$$
|
$
|
$
|
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 8)
|
-
|
-
|
22,577
|
-
|
-
|
22,577
|
Stock
options to employees (Note 7)
|
-
|
-
|
1,676,974
|
-
|
-
|
1,676,974
|
Proceeds
from ATM financing (Note 6)
|
105,815
|
2,495,615
|
-
|
-
|
-
|
2,495,615
|
Financing
cost for shares issued (Note 6)
|
-
|
(314,989)
|
-
|
-
|
-
|
(314,989)
|
Issuance
of common shares on exercise of warrants (Note 9)
|
16,801
|
430,573
|
(106,315)
|
-
|
-
|
324,258
|
Common
shares issued for options exercised (Note 7)
|
700
|
18,935
|
(6,470)
|
-
|
-
|
12,465
|
Modification
of convertible debenture (Note 5)
|
-
|
-
|
220,569
|
-
|
-
|
220,569
|
Net
loss and comprehensive loss
|
-
|
-
|
-
|
-
|
(6,346,504)
|
(6,346,504)
|
Balance, August 31, 2017
|
3,102,315
|
32,460,925
|
35,824,406
|
284,421
|
(69,362,523)
|
(792,771)
|
|
|
|
|
|
|
|
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 8)
|
-
|
-
|
7,565
|
-
|
-
|
7,565
|
Stock
options to employees (Note 7)
|
-
|
-
|
120,348
|
-
|
-
|
120,348
|
Proceeds
from issuance of shares and warrants (Note 6)
|
883,333
|
4,184,520
|
1,115,480
|
-
|
-
|
5,300,000
|
Cost
of warrant issued to placement agent (Note 9)
|
-
|
(141,284)
|
141,284
|
-
|
-
|
-
|
Share
issuance cost (Note 6)
|
-
|
(635,370)
|
(174,974)
|
-
|
-
|
(810,344)
|
Net
loss and comprehensive loss
|
-
|
-
|
-
|
-
|
(9,962,968)
|
(9,962,968)
|
Rounding
of fractional shares after consolidation (Note 2)
|
(106)
|
-
|
-
|
-
|
-
|
-
|
Balance, August 31, 2018
|
4,353,678
|
38,697,900
|
37,895,090
|
284,421
|
(81,836,427)
|
(4,959,016)
|
|
|
|
|
|
|
|
See
accompanying notes to condensed unaudited interim consolidated
financial statements
|
Intellipharmaceutics International Inc.
|
|
|
|
|
Condensed
unaudited interim consolidated statements of cash
flows
|
(Stated
in U.S. dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
|
|
|
|
|
Net loss
|
(3,954,104)
|
(2,550,314)
|
(9,962,968)
|
(6,346,504)
|
Items
not affecting cash
|
|
|
|
|
Depreciation
|
155,288
|
138,401
|
457,314
|
343,187
|
Stock-based
compensation (Note 7)
|
25,542
|
32,105
|
120,348
|
1,676,974
|
Deferred
share units (Note 8)
|
-
|
7,222
|
7,565
|
22,577
|
Accreted
interest on convertible debenture (Note 5)
|
16,369
|
48,675
|
48,510
|
192,320
|
Unrealized
foreign exchange loss (gain)
|
(14,882)
|
95,834
|
(11,365)
|
76,339
|
|
|
|
|
|
Change
in non-cash operating assets & liabilities
|
|
|
|
|
Accounts
receivable
|
182,558
|
137,446
|
426,279
|
(372,889)
|
Investment
tax credits
|
(45,000)
|
(72,627)
|
(135,001)
|
17,539
|
Inventory
|
(64,804)
|
305,201
|
(134,655)
|
(187,416)
|
Prepaid
expenses, sundry and other assets
|
(108,178)
|
296,071
|
(341,546)
|
226,194
|
Accounts
payable, accrued liabilities and employee costs
payable
|
2,594,283
|
282,273
|
3,329,225
|
549,240
|
Deferred
revenue (Note 3)
|
(75,000)
|
(75,000)
|
(225,000)
|
(225,000)
|
Cash
flows used in operating activities
|
(1,287,928)
|
(1,354,713)
|
(6,421,294)
|
(4,027,439)
|
|
|
|
|
|
Financing activities
|
|
|
|
|
Repayment
of principal on convertible debenture (Note 5)
|
-
|
-
|
-
|
(150,000)
|
Repayment
of capital lease obligations
|
-
|
(3,787)
|
-
|
(14,829)
|
Proceeds
from issuance of common shares on at-the-market financing (Note
6)
|
-
|
1,047,143
|
-
|
2,495,615
|
Proceeds
from issuance of common shares on exercise of warrants (Note 6 and
9)
|
-
|
28,950
|
-
|
324,258
|
Proceeds
from issuance of common shares on option exercise (Note
7)
|
-
|
-
|
-
|
12,465
|
Proceed
from issuance of shares and warrants (Note 6 and 9)
|
-
|
-
|
5,300,000
|
-
|
Offering
costs
|
-
|
(151,972)
|
(618,689)
|
(223,640)
|
Cash
flows provided from financing activities
|
-
|
920,334
|
4,681,311
|
2,443,869
|
|
|
|
|
|
Investing activity
|
|
|
|
|
Purchase
of property and equipment (Note 4)
|
(15,358)
|
(306,083)
|
(99,690)
|
(1,825,698)
|
Cash
flows used in investing activities
|
(15,358)
|
(306,083)
|
(99,690)
|
(1,825,698)
|
|
|
|
|
|
Decrease
in cash
|
(1,303,286)
|
(740,462)
|
(1,839,673)
|
(3,409,268)
|
Cash,
beginning of period
|
1,360,674
|
1,475,618
|
1,897,061
|
4,144,424
|
Cash, end of period
|
57,388
|
735,156
|
57,388
|
735,156
|
|
|
|
|
|
Supplemental cash flow information
|
|
|
|
|
Interest
paid
|
12,419
|
-
|
92,029
|
82,398
|
Taxes
paid
|
-
|
-
|
-
|
-
|
|
|
|
|
|
See
accompanying notes to condensed unaudited interim consolidated
financial statements
|
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(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 and other incidental services. 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.
Going concern
The condensed
unaudited interim 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 $3,954,104 and
$9,962,968 for the three and nine months ended August 31, 2018
(three and nine months ended August 31, 2017 – loss of
$2,550,314 and $6,346,504), and has an accumulated deficit of
$81,836,427 as at August 31, 2018 (November 30, 2017 -
$71,873,459). The Company also has a working capital deficiency of
$6,546,324 as at August 31, 2018 (November 30, 2017 - $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 at all.
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 holders will likely
experience dilution, and the incurring of indebtedness would result
in increased debt
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
1.
Nature
of operations (continued)
Going concern (continued)
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 condensed
unaudited interim 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 condensed
unaudited interim 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 condensed unaudited interim 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 open of 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 market open on
September 14, 2018. Under accounting principles generally accepted
in the U.S. (“U.S. GAAP”) the change has been disclosed
retroactively.
The condensed
unaudited interim consolidated financial statements do not conform
in all respects to the annual requirements of U.S. GAAP.
Accordingly, these condensed unaudited interim consolidated
financial statements should be read in conjunction with the audited
consolidated financial statements and notes thereto for the year
ended November 30, 2017.
These condensed
unaudited interim consolidated financial statements have been
prepared using the same accounting policies and methods as those
used by the Company in the annual audited consolidated financial
statements for the year ended November 30, 2017. The condensed
unaudited interim consolidated financial statements reflect all
adjustments necessary for the fair presentation of the
Company’s financial position and results of operation for the
interim periods presented. All such adjustments are normal and
recurring in nature.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
2.
Basis
of presentation (continued)
(a) Basis of consolidation
(continued)
All inter-company
accounts and transactions have been eliminated on
consolidation.
(b) Use of estimates
The preparation of
the condensed unaudited interim consolidated financial statements
in conformity with accounting principles generally accepted in the
United States of America (“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 period. Actual results could differ from those
estimates.
3.
Significant
accounting policies
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.
The Company
accounts for revenue in accordance with the provisions of
Accounting Standards Codification (“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 and other
incidental services. 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 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
condensed unaudited interim 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. Under the
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(a)
Revenue recognition (continued)
Licensing (continued)
terms of this
agreement, the Company is responsible for the manufacture of
approved products for subsequent sale by Mallinckrodt in the U.S.
market, one of which (the Company’s generic Seroquel
XR®) received final approval from the FDA in 2017. 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 condensed unaudited interim 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 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 three and
nine months ended August 31, 2018, the Company recognized $75,000
and $225,000 (three and nine months ended August 31, 2017 - $75,000
and $225,000) of revenue based on a straight-line basis over the
expected term of the Mallinckrodt agreement of 10
years.
As of August 31,
2018, the Company has recorded a deferred revenue balance of
$2,437,500 (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.
(b)
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.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
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 August 31, 2018, the Company had
inventories of $250,322 (November 30, 2017 - $115,667) 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.
(d)
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 condensed unaudited interim consolidated statements of
operations and comprehensive loss.
The Company’s
functional and reporting currency is the U.S. dollar.
(e)
Future accounting pronouncements
In May 2014, the
Financial Accounting Standards Board ("FASB") issued Accounting
Standards Update (“ASU”) No. 2014-09, 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 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 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 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 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
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
3.
Significant
accounting policies (continued)
(e)
Future accounting pronouncements (continued)
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 2016-15, Statement of Cash Flows (Topic 230)
Classification of Certain Cash Receipts and Cash Payments, which
will make eight targeted changes to how cash receipts and cash
payments are presented and classified in the Statement of Cash
Flows. ASU 2016-15 will be effective on May 1, 2018 and will
require adoption on a retrospective basis unless it is
impracticable to apply, in which case the Company would be required
to apply the amendments prospectively as of the earliest date
practicable. The Company adopted ASU 2016-15 on May 1, 2018. The
adoption did not have an impact on the Company’s interim
consolidated financial statements for the three and nine months
ended August 31, 2018.
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 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 May 2017, the
FASB issued ASU 2017-09 in relation to Compensation —Stock
Compensation (Topic 718), Modification Accounting. The amendments
provide guidance about which changes to the terms or conditions of
a share-based payment award 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 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.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
4.
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
|
-
|
-
|
79,354
|
-
|
-
|
-
|
99,690
|
Balance
at August 31, 2018
|
551,086
|
156,059
|
172,498
|
5,366,157
|
1,441,452
|
276,300
|
76,458
|
8,040,010
|
|
|
|
|
|
|
|
|
|
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
|
57,334
|
9,349
|
7,876
|
308,494
|
62,126
|
11,625
|
510
|
457,314
|
Balance
at August 31, 2018
|
343,817
|
140,477
|
127,866
|
2,977,726
|
1,255,072
|
210,423
|
74,702
|
5,130,083
|
|
|
|
|
|
|
|
|
|
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
|
August
31, 2018
|
207,269
|
15,582
|
44,632
|
2,388,431
|
186,380
|
65,877
|
1,756
|
2,909,927
|
As at August 31,
2018, there was $595,589 (November 30, 2017 - $728,309) of
laboratory equipment that was not available for use and therefore,
no depreciation has been recorded for such laboratory
equipment.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
5.
Due
to releated parties
Convertible debenture
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
|
$1,338,975
|
$1,290,465
|
On January 10,
2013, the Company completed a private placement financing of an
unsecured convertible debenture in the original principal amount of
$1.5 million (the “Debenture”), which had an original
maturity date of January 1, 2015. The 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, principal shareholders, directors and executive
officers of the Company purchased the Debenture and provided the
Company with the $1.5 million of the proceeds for the
Debenture.
Effective October
1, 2014, the maturity date of the 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 Debenture
using a 15% imputed rate of interest.
Effective June 29,
2015, the July 1, 2015 maturity date for the 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 Debenture as the change in the fair value of the
embedded conversion option was greater than 10% of the carrying
amount of the Debenture. In accordance with ASC 470-50-40, the
Debenture was recorded at fair value. The difference between the
fair value of the convertible Debenture after the extension and the
net carrying value of the 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 Debenture over the remaining
life of the Debenture using a 14.6% imputed rate of
interest.
Effective December
8, 2015, the January 1, 2016 maturity date of the 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 Debenture using a 6.6% imputed rate of
interest.
Effective May 26,
2016, the July 1, 2016 maturity date of the 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 Debenture using a 4.2% imputed rate of
interest.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
5.
Due
to releated parties (continued)
Convertible debenture (continued)
Effective December
1, 2016, the maturity date of the 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 Debenture using a 26.3% imputed rate of
interest.
Effective March 28,
2017, the maturity date of the 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 Debenture
using a 15.2% imputed rate of interest.
Effective September
28, 2017, the maturity date of the 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 Debenture using a 4.9% imputed rate of
interest.
Accreted interest
expense during the three and nine months ended August 31, 2018 is
$16,369 and $48,510 (three and nine months ended August 31, 2017 -
$48,675 and $192,320) and has been included in the condensed
unaudited interim consolidated statements of operations and
comprehensive loss. In addition, the coupon interest on the
Debenture for the three and nine months ended August 31, 2018 is
$40,805 and $121,528 (three and nine months ended August 31, 2017
– $40,805 and $122,168) and has also been included in the
condensed unaudited interim consolidated statements of operations
and comprehensive loss.
Effective October
1, 2018, the maturity date for the Debenture was extended to April
1, 2019.
6.
Capital
stock
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 August 31, 2018, the Company had 4,353,678 (November
30, 2017 – 3,470,451) common shares issued and outstanding
and no preference shares issued and outstanding. Two officers and
directors of IPC owned directly and through their family holding
company (“Odidi Holdco”) 578,131 (November 30, 2017
– 578,131) common shares or approximately 13% (November 30,
2017 – 17%) of IPC.
(b)
In November 2013,
the Company entered into an equity distribution agreement with Roth
Capital Partners, LLC (“Roth”), pursuant to which the
Company from time to time was able to 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 be permitted under applicable
exchange rules and securities laws and regulations) through
at-the-market issuances on the Nasdaq or
otherwise.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
6.
Capital
stock (continued)
Authorized, issued and outstanding (continued)
During the three
and nine months ended August 31, 2018, an aggregate of Nil (three
and nine months ended August 31, 2017 – 46,498 and 105,815)
common shares were sold on Nasdaq for gross proceeds of $Nil (three
and nine months ended August 31, 2017 – $1,047,143 and
$2,495,615), with net proceeds to the Company of $Nil (three and
nine months ended August 31, 2017 – $1,017,378 and
$2,423,621), 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. There can be no assurance that any additional shares will
be sold under the at-the-market program.
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
three and nine months ended August 31, 2018, costs directly related
to the at the-market facility of $Nil (three and nine months ended
August 31, 2017 – $29,766 and $71,994) were recorded in share
offering costs and an additional $Nil and $120,271 (three and nine
months ended August 31, 2017 - $103,452 and $172,520) of deferred
costs were amortized and recorded in share offering costs related
to the base shelf prospectus and to the at-the-market
facility.
(c)
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 will be exercisable six
months following the closing date and will expire 30 months after
the date they become exercisable, have a term of three years
and 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
“Placement Agent Warrants”).
The holders of
October 2017 Warrants and 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 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 for equity
classification.
The Company
recorded $3,257,445 as the value of common shares under Capital
stock and $742,555 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 9.
The direct costs
related to the issuance of the common shares and 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.
(d)
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 will be exercisable six
months following the closing date and will expire 30 months after
the date they become exercisable, and 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 Placement Agent
Warrants”).
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
6.
Capital
stock (continued)
Authorized, issued and outstanding (continued)
The holders of
March 2018 Warrants and March 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 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 for equity
classification.
The Company
recorded $4,184,520 as the value of common shares under Capital
stock and $1,115,480 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 9.
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.
7.
Options
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
4,353,678 based on the number of issued and outstanding common
shares as at August 31, 2018. As at August 31, 2018, 282,090
options are outstanding and there were 153,277 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 248,754 performance-based stock options have
vested as of August 31, 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.
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 $45,793 related to vested
performance options during the nine months ended August 31, 2018.
These options were outstanding as at August 31, 2018.
In the three and
nine months ended August 31, 2018, Nil (three and nine months ended
August 31, 2017 – Nil) stock options were
granted.
The fair value of
each option grant is estimated on the date of grant using the
Black-Scholes Option-Pricing Model, consistent with the provisions
of ASC topic 718.
Option pricing
models require the use of subjective assumptions, changes in these
assumptions can materially affect the fair value of the
options.
The Company
calculates expected volatility based on historical volatility of
the Company’s peer group that is publicly traded for options
that have an expected life that is more than eight years. For
options that have an expected life of less than eight years the
Company uses its own volatility.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
7.
Options
continued
The expected term,
which represents the period of time that options granted are
expected to be outstanding, is estimated based on the historical
average of the term and historical exercises of the
options.
The risk-free rate
assumed in valuing the options is based on the U.S. treasury yield
curve in effect at the time of grant for the expected term of the
option. The expected dividend yield percentage at the date of grant
is Nil as the Company is not expected to pay dividends in the
foreseeable future.
Details of stock
option transactions in Canadian dollars (“C$”) are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
#
|
$
|
|
#
|
$
|
$
|
Outstanding,
beginning of period
|
582,811
|
32.0
|
17.2
|
539,246
|
34.8
|
18.8
|
Exercised
|
-
|
-
|
-
|
(700)
|
23.2
|
12.0
|
Expired
|
(15,827)
|
54.2
|
39.2
|
(215)
|
679.7
|
524.8
|
Forfeited
|
(8,500)
|
11.9
|
10.2
|
-
|
-
|
-
|
Balance
at end of period
|
558,484
|
31.6
|
16.7
|
538,331
|
34.5
|
18.6
|
|
|
|
|
|
|
|
Options
exercisable end of period
|
503,444
|
32.5
|
17.2
|
494,024
|
34.7
|
19.0
|
Total unrecognized
compensation cost relating to the unvested performance-based stock
options at August 31, 2018 is approximately $793,795 (August 31,
2017 - $788,887). For the three and nine months ended August 31,
2018, no compensation cost has been recognized for the remaining
unvested performance-based options (three and nine months ended
August 31, 2017 - $Nil and $1,577,772).
For the three and
nine months ended August 31, 2018, no options were exercised. For
the three and nine months ended August 31, 2017, Nil and 700
options were exercised for cash consideration of $Nil and $12,465,
respectively.
The following table
summarizes the components of stock-based compensation
expense.
|
|
|
Stock-based
compensation related to:
|
|
|
|
|
|
$
|
$
|
$
|
$
|
Research and
development
|
11,072
|
12,951
|
79,067
|
1,614,977
|
Selling, general
and administrative
|
14,470
|
19,154
|
41,281
|
61,997
|
|
25,542
|
32,105
|
120,348
|
1,676,974
|
The Company has
estimated its stock option forfeitures to be approximately 4% for
the three and nine months ended August 31, 2018 (three and nine
months ended August 31, 2017 – 4%).
8.
Deferred
share units
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.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
8.
Deferred
share units (continued)
During the three
and nine months ended August 31, 2018, one non-management board
member elected to receive director fees in the form of DSUs under
the Company’s DSU Plan. As at August 31, 2018, 10,279 DSUs
are outstanding and 721 DSUs are available for grant under the DSU
Plan. The Company recorded the following amounts related to
DSUs for each of the three and nine months ended August 31, 2018
and three and nine months ended August 31, 2017 in additional paid
in capital and accrued the following amounts as at August 31, 2018
and August 31, 2017:
|
|
|
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
Additional
paid in capital
|
-
|
-
|
7,222
|
372
|
7,565
|
866
|
22,577
|
920
|
Accrued
liability
|
-
|
-
|
7,778
|
818
|
-
|
-
|
7,778
|
818
|
9.
Warrants
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.
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”).
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.
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
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
purchase an
additional 181,818 common shares. The
October 2017 Warrants are exercisable six months following the
closing date and will expire 30 months after the date they become
exercisable, and have an exercise price of $12.50 per common
share. The Company also issued the 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 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 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.
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 warrants to purchase an additional 441,666
common shares. The March 2018 Warrants
will be exercisable six months following the closing date and will
expire 30 months after the date they become exercisable, and
have an exercise price of $6.00 per common share. The Company also
issued the March 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 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 Placement Agents 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 following table
provides information on the 963,309 warrants outstanding and
exercisable as of August 31, 2018:
Warrant
|
Exercise
Price
|
Number outstanding
|
Expiry
|
Shares issuable 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
|
March
2018 Warrants
|
$6.00
|
291,666
|
March
16, 2021
|
291,666
|
March
2018 Warrants
|
$6.00
|
150,000
|
March
21, 2021
|
150,000
|
Placement
Agent Warrants
|
$13.750
|
18,181
|
October
13, 2020
|
18,181
|
March
Placement Agent Warrants
|
$7.50
|
29,166
|
March
16, 2021
|
29,166
|
March
Placement Agent Warrants
|
$7.50
|
15,000
|
March
21, 2021
|
15,000
|
|
|
963,309
|
|
824,570
|
During the three
and nine months ended August 31, 2018, there were no cash exercises
in respect of warrants (three and nine months ended August 31, 2017
– 3,000 and 33,601) and no cashless exercise (three and nine
months ended August 31, 2017 - Nil) of warrants, resulting in the
issuance of Nil (three and nine months ended August 31, 2017
– 1,500 and 16,801) and Nil (three and nine months ended
August 31, 2017 - Nil) common shares, respectively.
For the warrants
exercised, the Company recorded a charge to capital stock of $Nil
(three and nine months ended August 31, 2017 - $38,442 and
$430,573) comprised of proceeds of $Nil (three and nine months
ended August 31, 2017 – $28,950 and $324,258) and the
associated amount of $Nil (three and nine months ended August 31,
2017 - $9,492 and $106,315) previously recorded in additional
paid-in-capital.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
Details of warrant
transactions are as follows:
|
|
|
|
|
|
|
|
Total
|
Outstanding,
December 1, 2017
|
149,174
|
87,000
|
277,478
|
181,818
|
18,181
|
-
|
-
|
713,651
|
Issued
|
-
|
-
|
-
|
-
|
-
|
441,666
|
44,166
|
485,832
|
Expired
|
(149,174)
|
(87,000)
|
-
|
-
|
-
|
-
|
-
|
(236,174)
|
Outstanding,
August
31, 2018
|
-
|
-
|
277,478
|
181,818
|
18,181
|
441,666
|
44,166
|
963,309
|
|
|
|
|
|
Outstanding,
December 1, 2016
|
149,174
|
87,000
|
311,474
|
547,648
|
Exercised
|
-
|
-
|
(30,601)
|
(30,601)
|
Outstanding,August
31, 2017
|
149,174
|
87,000
|
280,873
|
517,047
|
10.
Income
taxes
The Company has had
no taxable income under the Federal and Provincial tax laws of
Canada for the three and nine months ended August 31, 2018 and
August 31, 2017. The Company has non-capital loss carry-forwards at
August 31, 2018, totaling $43,236,241 in Canada and $47,132 in
United States federal income tax losses that must be offset against
future taxable income. If not utilized, the loss carry-forwards
will expire between 2028 and 2038.
For the three and
nine months ended August 31, 2018, the Company had a cumulative
carry-forward pool of Canadian Federal Scientific Research &
Experimental Development expenditures in the amount of
approximately $15,700,000 which can be carried forward
indefinitely.
For the three and
nine months ended August 31, 2018, the Company had approximately
$3,000,000 of unclaimed Investment Tax Credits which expire from
2025 to 2037. These credits are subject to a full valuation
allowance as they are not more likely than not to be
realized.
11.
Contingencies
From
time to time, the Company may be exposed to claims and legal
actions in the normal course of business. As at August 31, 2018,
and continuing as at October 15, 2018, 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 received notice
that Purdue Pharma L.P., 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 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
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
11.
Contingencies
(continued)
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 remains 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 dismiss
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. Infringement claims related to this
patent have been dismissed without prejudice.
On
October 4, 2018, the parties to the case mutually agreed to
postpone the scheduled court date pending a case status conference
scheduled for December 17, 2018.
In July 2017, three
complaints were filed in the U.S. District Court for the Southern
District of New York asserting claims under the federal securities
laws against the Company and two of its executive officers on
behalf of a putative class of purchasers of the Company’s
securities. In a subsequent order, the Court consolidated the three
actions under the caption Shanawaz v. Intellipharmaceutics
Int’l Inc., et al., No. 1:17-cv-05761 (S.D.N.Y.), appointed
lead plaintiffs in the consolidated action, and approved lead
plaintiffs’ selection of counsel. Lead plaintiffs filed a
consolidated amended complaint on January 29, 2018. In the amended
complaint, lead plaintiffs purport to 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 filed a motion to dismiss in response to the claim. A
response by the plaintiffs was filed May 31, 2018. A reply in
support of the motion to dismiss was filed by the Company on June
29, 2018. The Company and the other defendants intend to vigorously
defend themselves against the claims asserted in the consolidated
action.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
12.
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:
|
August 31, 2018
|
November 30, 2017
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
Financial
Liabilities
|
|
|
|
|
Convertible debenture(i)
|
1,338,975
|
1,346,445
|
1,290,465
|
1,316,386
|
(i)
The Company
calculates the interest rate for the Debenture 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 Debenture and the amounts due to related
parties.
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.
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
12.
Financial
instruments (continued)
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
|
330,189
|
756,468
|
Less
allowance for doubtful accounts
|
(66,849)
|
(66,849)
|
Total
accounts receivable, net
|
263,340
|
689,619
|
|
|
|
Not
past due
|
263,330
|
689,619
|
Past
due for more than 31 days
|
|
|
but
no more than 90 days
|
-
|
5,176
|
Past
due for more than 120 days
|
66,859
|
61,673
|
Total
accounts receivable, gross
|
330,189
|
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 three
and nine months ended August 31, 2018, two customers accounted for
substantially all the revenue and all the accounts receivable of
the Company and for the three and nine months ended August 31,
2017, Par accounted for substantially all of the revenue and all of
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.
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 August 31, 2018:
Intellipharmaceutics
International Inc.
Notes to the
condensed unaudited interim consolidated financial
statements
For the three and
nine months ended August 31, 2018 and 2017
(Stated in U.S.
dollars)
12.
Financial
instruments (continued)
(d)
Liquidity risk (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
$
|
$
|
Third
parties
|
|
|
|
|
|
|
Accounts
payable
|
5,857,726
|
-
|
-
|
-
|
-
|
5,857,726
|
Accrued
liabilities
|
741,875
|
-
|
-
|
-
|
-
|
741,875
|
Related
parties
|
|
|
|
|
|
|
Employee
costs payable
|
216,926
|
-
|
-
|
-
|
-
|
216,926
|
Convertible
debenture (Note 5)
|
1,363,750
|
-
|
-
|
-
|
-
|
1,363,750
|
|
8,180,277
|
-
|
-
|
-
|
-
|
8,180,277
|
13.
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
|
|
|
|
|
Canada
|
-
|
-
|
-
|
-
|
United
States
|
413,555
|
1,189,739
|
1,325,040
|
4,426,617
|
|
413,555
|
1,189,739
|
1,325,040
|
4,426,617
|
|
|
|
|
|
|
|
|
|
2018
|
2017
|
|
$
|
$
|
Total
assets
|
|
|
Canada
|
5,633,986
|
7,396,781
|
|
|
|
Total
property and equipment
|
|
|
Canada
|
2,909,927
|
3,267,551
|
14.
Subsequent
event
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”), The 2018 Debenture has
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. Dr. Isa Odidi
and Dr. Amina Odidi, who are principal shareholders, directors and
executive officers of the Company provided the Company with the
$0.5 million of the proceeds for the 2018 Debenture.
2018
Third Quarter
Management Discussion and Analysis
MANAGEMENT
DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FOR
THE THREE AND NINE MONTHS ENDED AUGUST 31, 2018
The following
Management Discussion and Analysis (“MD&A”) should
be read in conjunction with the August 31, 2018 condensed unaudited
interim consolidated financial statements of Intellipharmaceutics
International Inc. The condensed unaudited interim 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 condensed
unaudited interim 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 October 15,
2018 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), 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™, RexistaTM, 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 Nasdaq and
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 expectations regarding our
recent reverse stock split, 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”,
“goals”, “set to”, “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, on 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 maintain compliance with the continued listing
requirements of the principal markets on which our securities are
traded including risks or uncertainties related to our ability to
implement our plan to comply with The
NASDAQ Stock Market LLC ("Nasdaq") continued listing
standards, 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 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 and our generic Seroquel XR®
tablets, 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
recently-enacted 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 (previously
referred to as RexistaTM) (“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
●
In October
2018, we entered into an Underwriting Agreement (the
“Underwriting Agreement”) with H.C. Wainwright &
Co., LLC (“H.C. Wainwright”), pursuant to which we
agreed to issue and sell, in an underwritten public offering (the
“October 2018 Offering”), 827,970 common shares and an
aggregate of 16,563,335 pre-funded warrants (“Pre-Funded
Warrants”) exercisable into an aggregate of 16,563,335 common
shares (the “Warrant Shares”) together with common
share purchase warrants to purchase up to an aggregate of
17,391,305 common shares (“Firm Warrants”). We also
granted H.C. Wainwright an option to purchase up to 2,608,695 additional
common shares at a purchase price of $0.74 per share and/or
additional warrants to purchase up to 2,608,695 additional common
shares at a purchase price of $0.01 each, less the underwriting
discount, to cover over-allotments (if any). The common shares
are being offered and sold to purchasers in units
(“Units”), each of which includes one common share and
one Firm Warrant, and the Pre-Funded Warrants are being offered and
sold to purchasers in units (“Pre-Funded Units”), each
of which includes one Pre-Funded Warrant and one Firm Warrant. The
offering price is $0.75 per Unit and $0.74 per Pre-Funded Unit.
Each Firm Warrant will be exercisable for one common share
immediately upon the closing of the offering at a price of $0.75
per common share, subject to adjustment in certain circumstances,
and will expire five years from the date of issuance. Each
Pre-Funded Warrant will be immediately exercisable for one common
share at an exercise price of $0.01 per Pre-Funded Warrant and may
be exercised at any time after closing until all of the Pre-Funded
Warrants are exercised in full. The Pre-Funded Units are being
offered and sold to purchasers whose purchase of Units in the
offering would otherwise result in the purchaser, together with its
affiliates and certain related parties, beneficially owning more
than 4.99% (or, at the election of such purchaser, 9.99%) of our
outstanding common shares immediately following the consummation of
the October 2018 Offering. The closing of the October 2018
Offering is expected to take place on or about October 16, 2018,
subject to the satisfaction of customary closing
conditions.
●
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.
●
As more fully
described below, in October 2018, we announced that we had regained
compliance with the Nasdaq minimum bid price requirement and that
the Nasdaq Hearings Panel (the “Hearings Panel”) had
granted our request for continued listing through October 17, 2018
while we work to regain compliance with Nasdaq’s $2.5 million
stockholders’ equity continued listing
requirement.
●
In September 2018,
we announced a one-for-ten share consolidation (the “reverse
split”). At a special meeting of our shareholders held on
August 15, 2018, our shareholders granted our Board of Directors
discretionary authority to implement a consolidation of our issued
and outstanding common shares 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. 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, the Company filed articles of
amendment which implemented the reverse split, and our shares began
trading on each of The NASDAQ Capital Market (“Nasdaq”)
and the Toronto Stock exchange (“TSX”) on a post-split
basis under the Company’s 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.
●
In September 2018,
we announced that we issued in a private placement financing (the
''Debenture Financing'') an unsecured convertible debenture in the
principal amount of $0.5 million (the ''2018 Debenture''), which
will mature 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. The Debenture Financing was
non-brokered and the net proceeds are to be 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 (as described
below) have been dismissed without prejudice. As previously
announced, in April 2017, we 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 the Company in the U.S. District
Court for the District of Delaware in respect of the
Company’s new drug application filing for Oxycodone ER. The
parties to the case mutually agreed to dismiss the infringement
claims related to the Grünenthal ‘060 patent (which is
one of the six patents included in the original litigation case).
Infringement claims related to this patent have been dismissed
without prejudice. On October 4, 2018, the parties to the case
mutually agreed to postpone the scheduled court date pending a case
status conference scheduled for December 17, 2018.
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 in the U.S. market, or that it will ever be
successfully commercialized, 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, or that they will ever be successfully
commercialized and produce significant revenue for us.
NASDAQ
NOTICES AND NASDAQ HEARINGS PANEL GRANT OF REQUEST FOR CONTINUED
LISTING
●
While
we are currently not in compliance with the requirements for the
continued listing of our common shares on Nasdaq, as described
below, we have until October 17, 2018 to satisfy those
requirements. The October 2018 Offering and our recent reverse
split are important parts of our plan to regain compliance with
Nasdaq’s requirements for the continued listing of our common
shares.
●
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 the Company’s
hearing before the 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 Hearings Panel on May 17, 2018, and
subsequently received formal notice that the Hearings 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 Hearings 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 the Company that it had regained
compliance with Nasdaq’s minimum bid price requirement. On
September 29, 2018, we were advised that the Hearings Panel granted
an extension through October 17, 2018 for us to regain compliance
with Nasdaq’s stockholders’ equity continued listing
requirement. There is no assurance that we will be able to regain
compliance with Nasdaq’s stockholders’ equity
requirements, or if we do, that we will be able to maintain
compliance with Nasdaq’s listing requirements.
There
is no assurance that we will be able to regain or maintain
compliance with the Nasdaq listing requirements or, if we do regain
compliance, that we will be able to maintain such compliance over
the long term. If we are unable to do so, our common shares may be
delisted from Nasdaq and the liquidity and market price of our
common shares may be adversely impacted as a result. If our common
shares are delisted from Nasdaq, they may trade in the
over-the-counter system, which may be a less liquid market. In such
case, our shareholders’ ability to trade, or obtain
quotations of the market value of, our common shares could be
severely limited because of lower trading volumes and transaction
delays.
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
improve over the longer term; however, results for the next several
quarters are expected 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 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
are continuing to evaluate options to realize commercial returns on
this product, particularly in international markets. There can be
no assurance that our metformin hydrochloride extended release
tablets for the 500 and 750 mg strengths will be successfully
commercialized.
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
are actively exploring the best approach to maximize our commercial
returns from this approval and are looking at several international
markets where, despite lower volumes, product margins are typically
higher than in the U.S. There can be no assurance that our generic
Keppra XR® for the 500 and
750 mg strengths will be successfully commercialized.
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®) – ANDA under
FDA Review
■
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 novel Point of Divergence Drug Delivery System
(“nPODDDS™”). 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
Paradoxical OverDose Resistance Activating System
(“PODRAS™”) delivery technology was initially
introduced to enhance our Oxycodone ER 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 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 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. 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 incorporate this technology in our Oxycodone ER product
candidate. 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
|
$828
|
Intellipharmaceutics
and Par
|
Levetiracetam extended-release tablets
|
Keppra XR®
|
Partial onset
seizures for epilepsy
|
Received final
approval for the 500 and 750 mg strengths from FDA
|
ANDA
|
$127
|
Intellipharmaceutics
|
Venlafaxine hydrochloride extended-release capsules
|
Effexor XR®
|
Depression
|
ANDA application
for commercialization approval for 3 strengths under review by
FDA
|
ANDA
|
$745
|
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
|
$354
|
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
|
$406
(500 and 750 mg
only)
|
Intellipharmaceutics
|
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
ANDS
|
$157
|
Intellipharmaceutics
and Mallinckrodt
|
Lamotrigine extended-release tablets
|
Lamictal® XR™
|
Anti-convulsant for
epilepsy
|
ANDA application
for commercialization approval for 6 strengths under review by
FDA
|
ANDA
|
$541
|
Intellipharmaceutics
and Mallinckrodt
|
Desvenlafaxine extended-release tablets
|
Pristiq®
|
Depression
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$96
|
Intellipharmaceutics
and Mallinckrodt
|
Trazodone hydrochloride extended-release tablets
|
Oleptro™
|
Depression
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$1
|
Intellipharmaceutics
|
Carvedilol phosphate extended- release capsules
|
Coreg CR®
|
Heart failure,
hypertension
|
Late-stage
development
|
ANDA
|
$208
|
Intellipharmaceutics
|
Oxycodone hydrochloride controlled-release capsules
|
OxyContin®
|
Pain
|
NDA application
accepted February 2017 and under review by FDA
|
NDA
505(b)(2)
|
$1,625
|
Intellipharmaceutics
|
Pregabalin extended-release capsules
|
Lyrica®
|
Neuropathic
pain
|
Investigational New
Drug (“IND”) application submitted in August
2015
|
NDA
505(b)(2)
|
$5,299
|
Intellipharmaceutics
|
Ranolazine extended-release tablets
|
Ranexa®
|
Chronic
angina
|
ANDA application
for commercialization approval for 2 strengths under review by
FDA
|
ANDA
|
$1,001
|
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
August 2018 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 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.
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.
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 are actively
exploring the best approach to maximize our commercial returns from
this approval and are looking at several international markets
where, despite lower volumes, product margins are typically higher
than in the U.S. There can be no assurance that the Company's
generic Keppra XR® for the 500 and 750 mg strengths will be
successfully commercialized.
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. There can be
no assurance that our metformin extended-release tablets for the
500 and 750 mg strengths will be successfully
commercialized.
Oxycodone
ER (Abuse Deterrent Oxycodone Hydrochloride Extended-Release
Tablets) (formerly known as RexistaTM)
One of our
non-generic products under development is our Oxycodone ER 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 dismiss 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. Infringement claims related to this patent have
been dismissed without prejudice.
On October 4, 2018,
the parties to the case mutually agreed to postpone the scheduled
court date pending a case status conference scheduled for December
17, 2018.
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. However, we plan to
resubmit the application later this year.
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 samples 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.
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.
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.
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.
SELECTED
FINANCIAL INFORMATION
|
For the three months ended
|
For the nine months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
Revenue:
|
413,555
|
1,189,739
|
1,325,040
|
4,426,617
|
Expenses:
|
4,271,888
|
3,181,755
|
11,014,561
|
9,807,041
|
Loss
from operations
|
(3,954,104)
|
(2,550,314)
|
(9,962,968)
|
(6,346,504)
|
Loss
per common share, basic and diluted
|
(0.91)
|
(0.83)
|
(2.49)
|
(2.09)
|
|
|
|
|
|
|
As at
|
|
|
|
August 31,
|
November
30,
|
|
|
|
2018
|
2017
|
|
|
|
(UNAUDITED)
|
(AUDITED)
|
|
|
|
$
|
$
|
|
|
Cash
|
57,388
|
1,897,061
|
|
|
Total
assets
|
5,633,986
|
7,396,781
|
|
|
|
|
|
|
|
Convertible
debenture
|
1,338,975
|
1,290,465
|
|
|
Total
liabilities
|
10,593,002
|
7,010,398
|
|
|
Shareholders'
(deficit) equity
|
(4,959,016)
|
386,383
|
|
|
Total
liabilities and shareholders equity
|
5,633,986
|
7,396,781
|
|
|
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 condensed unaudited interim consolidated financial
statements for the three and nine months ended August 31,
2018.
Use
of Estimates
The preparation of
the condensed unaudited interim 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 period. 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 condensed unaudited interim 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 condensed unaudited interim 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 three and
nine months ended August 31, 2018, the Company recognized $75,000
and $225,000 (three and nine months ended August 31, 2017 - $75,000
and $225,000) of revenue based on a straight-line basis over the
expected term of the Mallinckrodt agreement of 10
years.
As of August 31,
2018, the Company has recorded a deferred revenue balance of
$2,437,500 (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 August 31, 2018, the Company had
inventories of $250,322 (November 30, 2017 - $115,667) 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 condensed unaudited interim consolidated statements of
operations and comprehensive loss.
The Company’s
functional and reporting currency is the U.S. dollar.
Convertible
debenture
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 5 to our condensed unaudited interim consolidated
financial statements. 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.
Future
accounting pronouncements
In May 2014, the
Financial Accounting Standards Board ("FASB") issued Accounting
Standards Update (“ASU”) No. 2014-09, 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 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 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 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 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 2016-15, Statement of Cash Flows (Topic 230)
Classification of Certain Cash Receipts and Cash Payments, which
will make eight targeted changes to how cash receipts and cash
payments are presented and classified in the Statement of Cash
Flows. ASU 2016-15 will be effective on May 1, 2018 and will
require adoption on a retrospective basis unless it is
impracticable to apply, in which case the Company would be required
to apply the amendments prospectively as of the earliest date
practicable. The Company adopted ASU 2016-15 on May 1, 2018. The
adoption did not have an impact on the Company’s interim
consolidated financial statements for the nine months ended August
31, 2018.
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 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 May 2017, the
FASB issued ASU 2017-09 in relation to Compensation - Stock
Compensation (Topic 718), Modification Accounting. The amendments
provide guidance about which changes to the terms or conditions of
a share-based payment award 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 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.
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.
The following are
selected financial data for the three and nine months ended August
31, 2018 and 2017.
|
For the three months ended
|
For the nine months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
|
%
|
$
|
$
|
|
%
|
Revenue:
|
|
|
|
|
|
|
|
|
Licensing
|
320,330
|
1,114,739
|
(794,409)
|
-71%
|
1,062,597
|
4,201,617
|
(3,139,020)
|
-75%
|
Up-front
fees
|
93,225
|
75,000
|
18,225
|
24%
|
262,443
|
225,000
|
37,443
|
17%
|
|
413,555
|
1,189,739
|
(776,184)
|
-65%
|
1,325,040
|
4,426,617
|
(3,101,577)
|
-70%
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
45,299
|
376,054
|
(330,755)
|
-88%
|
111,173
|
587,426
|
(476,253)
|
-81%
|
Gross
margin
|
368,256
|
813,685
|
(445,429)
|
-55%
|
1,213,867
|
3,839,191
|
(2,625,324)
|
-68%
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
3,324,221
|
2,298,804
|
1,025,417
|
45%
|
7,783,549
|
7,007,503
|
776,046
|
11%
|
Selling,
general and administrative
|
792,379
|
756,635
|
35,744
|
5%
|
2,773,698
|
2,468,436
|
305,262
|
12%
|
Depreciation
|
155,288
|
126,316
|
28,972
|
23%
|
457,314
|
331,102
|
126,212
|
38%
|
|
4,271,888
|
3,181,755
|
1,090,133
|
34%
|
11,014,561
|
9,807,041
|
1,207,520
|
12%
|
Loss
from operations
|
(3,903,632)
|
(2,368,070)
|
(1,535,562)
|
65%
|
(9,800,694)
|
(5,967,850)
|
(3,832,844)
|
64%
|
|
|
|
|
|
|
|
|
|
Net
foreign exchange gain/(loss)
|
9,406
|
(90,875)
|
100,281
|
-110%
|
17,106
|
(73,569)
|
90,675
|
-123%
|
Interest
income
|
8
|
5
|
3
|
60%
|
22
|
15,030
|
(15,008)
|
-100%
|
Interest
expense
|
(59,886)
|
(91,374)
|
31,488
|
-34%
|
(179,402)
|
(320,115)
|
140,713
|
-44%
|
Net
loss and comprehensive loss
|
(3,954,104)
|
(2,550,314)
|
(1,403,790)
|
55%
|
(9,962,968)
|
(6,346,504)
|
(3,616,464)
|
57%
|
Three months ended August 31, 2018 compared to the three months
ended August 31, 2017
Revenue
The Company
recorded revenues of $413,555 for the three months ended August 31,
2018 versus $1,189,739 for the three months ended August 31, 2017.
Revenues consisted primarily of licensing revenues from commercial
sales of the 5,10, 15, 20, 25, 30, 35 and 40 mg strengths of our
generic Focalin XR® under the Par agreement. Pursuant to the
Par agreement, we receive quarterly profit share payments on
Par’s U.S. sales of generic Focalin XR®. The decrease
in revenues in the three months ended August 31, 2018 is primarily
due to considerably lower profit share payments from sales of
generic Focalin XR® capsules in the U.S. 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 subsequently levelled off for the balance
of 2017. Profit share payments from the various strengths of
generic Focalin XR® for the third quarter of 2018 showed
continuation of competitive pressures on price. While gross sales
improved slightly in the second quarter of 2018, third quarter
sales show some decline and results continue to be impacted by
significant gross-to-net deductions such as chargebacks, rebates
and price adjustments. The 15, 25 and 30 mg strengths provide the
majority of the product’s gross sales, however, the other
strengths are not providing the material contribution to gross
sales or net profits expected since their launch in May and
November of last year. Pricing pressures on all strengths have
meant that chargebacks, rebates and pricing adjustments continue to
remain high and net profitability of the product has suffered as a
result. We currently expect revenues from this product to show
incremental improvement over the longer term, however, pricing
adjustments and similar deductions will likely continue to
negatively impact results for the next several
quarters.
Revenues from
generic Seroquel XR® showed some incremental improvement in
the third quarter of 2018, however, sales volumes are still well
below original expectations and market share gains have proven
difficult to achieve. Sales and net profits are improving
incrementally, however, any significant market share gains are
expected to take considerably more time to achieve, if at
all.
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.
Research and Development
Expenditures for
R&D for the three months ended August 31, 2018 were higher by
$1,025,417 compared to the three months ended August 31, 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 expense.
In the three months
ended August 31, 2018, we recorded $11,072 as expense for stock
based compensation for R&D employees. In the three months ended
August 31, 2017, we recorded $12,951 as expense for stock based
compensation for R&D employees.
Selling, General and Administrative
Selling, general
and administrative expenses were $792,379 for the three months
ended August 31, 2018 in comparison to $756,635 for the three
months ended August 31, 2017, an increase of $35,744. The increase
is primarily due to higher administrative costs, offset by a
decrease in wages and benefits and marketing costs.
Administrative
costs for the three months ended August 31, 2018 were $433,967 in
comparison to $251,876 in the three months ended August 31, 2017.
The increase relates primarily to higher professional
fees.
Expenditures for
wages and benefits for the three months ended August 31, 2018 were
$248,587 in comparison to $308,572 in the three months ended August
31, 2017. For the three months ended August 31, 2018, we recorded
$14,470 as expense for stock-based compensation compared to an
expense of $19,154 for the three months ended August 31,
2017.
Marketing costs for
the three months ended August 31, 2018 were $80,220 in comparison
to $160,957 in the three months ended August 31, 2017. The decrease
is primarily the result of a decrease in travel expenditures
related to business development and investor relations
activities.
Occupancy costs for
the three months ended August 31, 2018 were $29,605, relatively
consistent with $35,230 for the three months ended August 31,
2017.
Depreciation
Depreciation
expenses for the three months ended August 31, 2018 were $155,288
in comparison to $126,316 in the three months ended August 31,
2017. The increase is primarily due to the additional investment in
production, laboratory and computer equipment during the year ended
November 30, 2017.
Foreign Exchange Gain
Foreign exchange
gain was $9,406 for the three months ended August 31, 2018 in
comparison to a loss of $90,875 in the three months ended August
31, 2017. The foreign exchange gain for the three months ended
August 31, 2018 was due to the strengthening of the U.S. dollar
against the Canadian dollar during the three months ended August
31, 2018 as the exchange rates changed to $1.00 for C$1.3055 as at
August 31, 2018 from $1.00 for C$1.2948 as at May 31, 2018. The
foreign exchange gain for the three months ended August 31, 2017
was due to the weakening of the U.S. dollar against the Canadian
dollar during the three months ended August 31, 2017 as the
exchange rates changed to $1.00 for C$1.2536 as at August 31, 2017
from $1.00 for C$1.3500 as at May 31, 2017.
Interest Expense
Interest expense
for the three months ended August 31, 2018 was lower by $31,488
compared with the same period in 2017. This is due to interest
expense paid on the 2013 Debenture which accrues interest payable
at 12% annually and the related conversion option embedded
derivative accreted at an annual imputed interest of approximately
4.9% in the third quarter of 2018 in comparison to the third
quarter of 2017 when the 2013 Debenture imputed interest was
approximately 15.2%.
Net Loss
The Company
recorded net loss for the three months ended August 31, 2018 of
$3,954,104 or $0.91 per common share, compared with a net loss of
$2,550,314 or $0.83 per common share for the three months ended
August 31, 2017. In the three months ended August 31, 2018, the net
loss is primarily attributed to the lower licensing revenues from
commercial sales of generic Focalin XR®, combined with
increased third party R&D expenses and patent litigation
expenses. In the three months ended August 31, 2017, the lower net
loss was primarily attributed to lower third-party R&D
expenditures, as well as higher licensing revenue from commercial
sales of generic Focalin XR® and generic Seroquel XR® in
the third quarter of 2017.
Nine Months Ended August 31, 2018 Compared to the Nine Month Ended
August 31, 2017
Revenue
The Company
recorded revenues of $1,325,040 for the nine months ended August
31, 2018 versus $4,426,617 for the nine months ended August 31,
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 nine months ended August 31, 2018 compared to nine
months ended August 31, 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 showed
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 $111,173 for the nine months ended
August 31, 2018 versus $587,426 for the nine months ended August
31, 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 nine months ended August 31, 2018 were higher by
$776,046 compared to the nine months ended August 31, 2017. The
increase is primarily due to higher third party consulting fees and
higher patent litigation expenses, offset by higher non-cash
stock-based compensation expenses in the nine months ended August
31, 2017.
In the nine months
ended August 31, 2018, we recorded $79,067 of expenses for
stock-based compensation for R&D employees compared to
$1,614,977 for the nine months ended August 31, 2017, 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.
After adjusting for
the stock-based compensation expenses discussed above, expenditures
for R&D for the nine months ended August 31, 2018 were higher
by $2,311,956 compared to the nine months ended August 31, 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 $2,773,698 for the nine months
ended August 31, 2018 in comparison to $2,468,436 for the nine
months ended August 31, 2017, an increase of $305,262. The increase
is due to higher expenses related to administrative
costs.
Administrative
costs for the nine months ended August 31, 2018 were $1,476,609 in
comparison to $1,084,435 in the nine months ended August 31, 2017.
The increase in the nine months ended August 31, 2018 was due to
the increase in professional fees and legal fees.
Expenditures for
wages and benefits for the nine months ended August 31, 2018 were
$878,454 in comparison to $891,274 in the nine months ended August
31, 2017. For the nine months ended August 31, 2018, we recorded
$41,281 as expense for stock-based compensation compared to an
expense of $61,997 for the nine months ended August 31, 2017. After
adjusting for the stock-based compensation expenses, expenditures
for wages for the nine months ended August 31, 2018 were higher by
$7,896 compared to the nine months ended August 31,
2017.
Marketing costs for
the nine months ended August 31, 2018 were $318,853 in comparison
to $390,012 in the nine months ended August 31, 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 nine months ended August 31, 2018 were $99,782 in comparison to
$102,715 for the nine months ended August 31, 2017. The slight
decrease is due to lower facility operating expenses.
Depreciation
Depreciation
expenses for the nine months ended August 31, 2018 were $457,314 in
comparison to $331,102 in the nine months ended August 31, 2017.
The increase is primarily due to the additional investment in
production, laboratory and computer equipment during the nine
months ended August 31, 2018.
Foreign Exchange Gain
Foreign exchange
gain was $17,106 for the nine months ended August 31, 2018 in
comparison to a loss of $73,569 in the nine months ended August 31,
2017. The foreign exchange gain for the nine months ended August
31, 2018 was due to the strengthening of the U.S. dollar against
the Canadian dollar during the nine months ended August 31, 2018 as
the exchange rates changed to $1.00 for C$1.3055 as at August 31,
2018 from $1.00 for C$1.2888 as at November 30, 2017. The foreign
exchange loss for the nine months ended August 31, 2017 was due to
the weakening of the U.S. dollar against the Canadian dollar during
the nine months ended August 31, 2017 as the exchange rates changed
to $1.00 for C$1.3500 as at August 31, 2017 from $1.00 for C$1.3429
as at November 30, 2016.
Interest Income
Interest income for
the nine months ended August 31, 2018 was lower by $15,008 in
comparison to the prior period. For the nine months ended August
31, 2018 interest was lower largely due to interest received on
input tax credit refunds under the Scientific Research &
Experimental Development incentive program in the third quarter of
2017.
Interest Expense
Interest expense
for the nine months ended August 31, 2018 was lower by $140,713
compared with the prior period. This is due to interest expense
paid on the 2013 Debenture which accrues interest payable at 12%
annually and the related conversion option embedded derivative
accreted at an annual imputed interest of approximately 4.9% in the
first nine months of 2018 in comparison to the first nine months of
2017 when the 2013 Debenture imputed interest was approximately
15.2%.
Net Loss
The Company
recorded net loss for the nine months ended August 31, 2018 of
$9,962,968 or $2.49 per common share, compared with a net loss of
$6,346,504 or $2.09 per common share for the nine months ended
August 31, 2017. In the nine months ended August 31, 2018, the
higher net loss is attributed to the lower licensing revenues from
commercial sales of generic Focalin XR® 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 nine months ended August
31, 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.
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.
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
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)
|
November
30, 2016
|
569,096
|
(3,913,304)
|
(1.34)
|
(1.34)
|
(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
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
|
For the three months ended
|
|
For the nine months ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
|
|
|
Change
|
|
$
|
$
|
|
%
|
$
|
$
|
|
%
|
Cash
flows used in operating activities
|
(1,287,928)
|
(1,354,713)
|
66,785
|
-5%
|
(6,421,294)
|
(4,027,439)
|
(2,393,855)
|
59%
|
Cash
flows from financing activities
|
-
|
920,334
|
(920,334)
|
-100%
|
4,681,311
|
2,443,869
|
2,237,442
|
92%
|
Cash
flows used in investing activities
|
(15,358)
|
(306,083)
|
290,725
|
-95%
|
(99,690)
|
(1,825,698)
|
1,726,008
|
-95%
|
Decrease
in cash
|
(1,303,286)
|
(740,462)
|
(562,824)
|
76%
|
(1,839,673)
|
(3,409,268)
|
1,569,595
|
-46%
|
Cash,
beginning of period
|
1,360,674
|
1,475,618
|
(114,944)
|
-8%
|
1,897,061
|
4,144,424
|
(2,247,363)
|
-54%
|
Cash,
end of period
|
57,388
|
735,156
|
(677,768)
|
-92%
|
57,388
|
735,156
|
(677,768)
|
-92%
|
The Company had
cash of $57,388 as at August 31, 2018 compared to $1,360,674 as at
May 31, 2018. The decrease in cash during the three months ended
August 31, 2018 was mainly a result of expenditures for R&D
related to our ongoing product development activities for Oxycodone
ER and selling, general, and administrative expenses. The decrease
in cash during the three months ended August 31, 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.
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 the Nasdaq or otherwise. Under
the equity distribution agreement, the Company may 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. Sales of
common shares through Roth, if any, will be made at such time and
at such price as are 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 will pay Roth a commission,
or allow a discount, of 2.75% of the gross proceeds that the
Company receives 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. As of August 31, 2018, the Company has issued and sold
474,035 common shares with an aggregate offering price of
$13,872,929. During the three and nine months ended August 31,
2018, an aggregate of Nil (three and nine months ended August 31,
2017 – 46,498 and 105,815) common shares were sold on Nasdaq
for gross proceeds of $Nil (three and nine months ended August 31,
2017 – $1,047,143 and $2,495,615), with net proceeds to the
Company of $Nil (three and nine months ended August 31, 2017
– $1,017,378 and $2,423,621), 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. If the Company seeks to offer and
sell common shares under its at-the-market program, the Company
will file another prospectus supplement prior to making such
additional offers and sales. As a result of prior sales of the
Company’s common shares under the equity distribution
agreement, as at August 31, 2018, except as set forth below, the
Company may in the future (if funding is then available thereunder
and the Company files a prospectus supplement as noted below) offer
and sell its common shares with an aggregate purchase price of up
to $2,927,071 (or such lesser amount as may then be permitted under
applicable exchange rules and securities laws and regulations)
pursuant to the at-the-market 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. If the Company seeks to offer and sell common shares under
its at-the-market program, it will file another prospectus
supplement prior to making such additional offers and sales. The
Company is not required to sell shares under the equity
distribution agreement. Under Toronto Stock Exchange rules, the
number of common shares that may currently be offered under the
at-the-market program is 56,513. If the Company seeks to offer and
sell additional common shares under the at-the-market program, the
Company intends to remove or amend this limitation, although no
assurance can be given that the limitation will be removed or
amended. There can be no assurance that any additional shares will
be sold under the Company’s at-the-market program. The
underwriting agreement relating to the October 2018 Offering
contains various covenants, including a prohibition on the sales of
common shares or securities convertible or exchangeable into common
shares by the Company for a period of ninety days following the
date of the underwriting agreement, subject to certain exceptions.
The underwriting agreement also 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 three
months ended August 31, 2018, net cash flows used in operating
activities decreased to $1,287,928 as compared to net cash flows
used in operating activities for the three months ended August 31,
2017 of $1,354,713. The decrease was primarily a result of the
higher loss from operations, offset by an increase in accounts
payable and decrease in accounts receivable.
For the nine months
ended August 31, 2018, net cash flows used in operating activities
increased to $6,421,294 as compared to net cash flows used in
operating activities for the nine months ended August 31, 2017 of
$4,027,439. The increase was primarily a result of the higher loss
from operations, offset by an increase in accounts payable and a
decrease in accounts receivable.
R&D costs,
which are a significant portion of the cash flows used in operating
activities, related to continued internal research and development
programs are expensed as incurred. Equipment and supplies are
capitalized and amortized over their useful lives if they have
alternative future uses.
For the three and
nine months ended August 31, 2018, net cash flows provided from
financing activities were $Nil and $4,681,311, compared to $920,334
and $2,443,869 respectively, for the three and nine months ended
August 31, 2017. Net cash flows from financing activities in the
nine months ended August 31, 2018 were related 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. Net cash flows from financing activities in the three
and nine months ended August 31, 2017 principally related to
at-the-market issuances of common shares and the exercise of
previously issued warrants.
All non-cash items
have been added back or deducted from the condensed unaudited
interim consolidated 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® to show some improvement longer term. However, due to
continued competitive pressures, we expect net profit payments from
this product to be negatively impacted for the next several
quarters. As of August 31, 2018, the Company had a cash balance of
$0.1 million. As of October 15, 2018, our cash balance was $0.1
million. On October 12, 2018, we entered into an Underwriting
Agreement, pursuant to which we agreed to issue and sell, in an
underwritten public offering 827,970 common shares and an aggregate
of 16,563,335 pre-funded warrants exercisable into an aggregate of
16,563,335 common shares, together with common share purchase
warrants to purchase up to an aggregate of 17,391,305 common
shares. We also granted the Underwriter an option to purchase up to
2,608,695 additional common shares and/or additional warrants to
purchase up to 2,608,695 additional common shares at a purchase
price of $0.75 each, less the underwriting discount, to cover
over-allotments (if any). The net proceeds to us from this
offering will be approximately $11.1 million after deducting
underwriting discounts and commissions and estimated offering
expenses payable by us (or $12.9 million if the underwriter’s
option to purchase additional shares and/or warrants is exercised
in full). We currently intend to use the net proceeds from this
offering for general corporate purposes, which may include working
capital, capital expenditures, research and development, accounts
payable, and other commercial expenditures. The Company may need to
obtain additional funding as we further the development of our
product candidates. Other 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.
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.
Effective October
1, 2018, the maturity date for the 2013 Debenture was extended to
April 1, 2019. The Company currently expects to repay the current
outstanding principal amount of $1,350,000 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 Purdue litigation 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 August 31,
2018 the Company has 4,353,678 common shares issued and
outstanding, which is an increase of 883,227 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. The number of
options outstanding as of August 31, 2018 is 558,484, a decrease of
24,327 from November 30, 2017, due to the expiry of 15,827 options
and forfeiting of 8,500 options during the nine months ended August
31, 2018. The warrants outstanding as of August 31, 2018 represent
824,570 common shares issuable upon the exercise of 963,309
outstanding warrants, which represents an increase of 249,658
common shares (426,789 warrants) from November 30, 2017, due to the
issuance of 485,832 warrants to purchase 485,832 common shares and
the expiry of 236,174 warrants to purchase 59,043 common shares
during the nine months ended August 31, 2018. There were no
warrants exercised during the nine months ended August 31, 2018.
The number of deferred share units outstanding as of August 31,
2018 is 10,279, an increase of 866 from November 30, 2017. As of
October 15, 2018, the number of shares outstanding is
4,353,678.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT LIQUIDITY AND MARKET
RISK
Liquidity risk is
the risk that we will encounter difficulty raising liquid funds to
meet our commitments as they fall due. In meeting our liquidity
requirements, we closely monitor our 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 our 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 us to credit risk. We provide an
allowance for doubtful accounts equal to the estimated losses
expected to be incurred in the collection of accounts
receivable.
We are also exposed
to credit risk at period end from the carrying value of our cash.
We manage this risk by maintaining bank accounts with a Canadian
Chartered Bank. Our 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. We had no
foreign currency hedges or other derivative financial instruments
as of August 31, 2018. We did not enter into financial instruments
for trading or speculative purposes and we do not currently utilize
derivative financial instruments.
We have 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 us versus the U.S. dollar
would affect our loss and other comprehensive loss by $0.1
million.
WORKING
CAPITAL
Working capital
(defined as current assets minus current liabilities) has decreased
by approximately $5.5 million at August 31, 2018 from November 30,
2017, mainly a result of an increase in accounts payable and
decrease in cash, partially offset by an increase in prepaid
expenses and inventory. 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 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.
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.The Company currently expects to repay the current
outstanding principal amount of $1,350,000 on or about April 1,
2019, if the Company then has cash available.
CAPITAL
EXPENDITURES
Total cash capital
expenditures in the three and nine months ended August 31, 2018
were $15,358 and $99,690 compared to $306,083 and $1,825,698 in the
three and nine months ended August 31, 2017. 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
currently 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 with 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 2018.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
$
|
$
|
$
|
$
|
$
|
Third
parties
|
|
|
|
|
|
|
Accounts
payable
|
5,857,726
|
-
|
-
|
-
|
-
|
5,857,726
|
Accrued
liabilities
|
741,875
|
-
|
-
|
-
|
-
|
741,875
|
Related
parties
|
|
|
|
|
|
|
Employee
costs payable
|
216,926
|
-
|
-
|
-
|
-
|
216,926
|
Convertible
debenture (Note 5)
|
1,363,750
|
-
|
-
|
-
|
-
|
1,363,750
|
|
8,180,277
|
-
|
-
|
-
|
-
|
8,180,277
|
CONTINGENCIES
AND LITIGATION
From time to time,
we may be exposed to claims and legal actions in the normal course
of business. As at August 31, 2018, and continuing as at October
15, 2018, 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 dismiss 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. Infringement claims related to this patent have
been dismissed without prejudice.
On October 4, 2018,
the parties to the case mutually agreed to postpone the scheduled
court date pending a case status conference scheduled for December
17, 2018.
In July 2017, three
complaints were filed in the U.S. District Court for the Southern
District of New York asserting claims under the federal securities
laws against us and two of our executive officers on behalf of a
putative class of purchasers of our securities. In a subsequent
order, the Court consolidated the three actions under the caption
Shanawaz v. Intellipharmaceutics Int’l Inc., et al., No.
1:17-cv-05761 (S.D.N.Y.), appointed lead plaintiffs in the
consolidated action, and approved lead plaintiffs’ selection
of counsel. Lead plaintiffs filed a consolidated amended complaint
on January 29, 2018. In the amended complaint, lead plaintiffs
purport to 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 U.S. 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, we filed a motion to dismiss in response to the claim. A
response by the plaintiffs was filed on May 31, 2018. A reply in
support of the motion to dismiss was filed by the Company on June
29, 2018. We intend to vigorously defend against the claims
asserted in the consolidated 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 principal 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 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.The Company currently expects
to repay the current outstanding principal amount of $1,350,000 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 principal 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”),
currently 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
Armistice is participating in the October 2018
Offering.
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 August 31, 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 August 31,
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 August 31,
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 expect the transition to the
new framework to continue for the remainder of fiscal 2018.
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 the three
and nine months ended August 31, 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 August 31, 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 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 Keppra XR® and generic Glucophage
XR® product strengths that have been approved by the FDA.
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 August 31,
2018. We had an accumulated deficit of $81,836,427 as of August 31,
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 Purdue litigation 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.