FORM S-3
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ROCKWELL MEDICAL TECHNOLOGIES, INC.
(Exact Name of Registrant as Specified in Its Charter)
|
|
|
Michigan
|
|
38-3317208 |
(State or Other Jurisdiction of Incorporation or Organization)
|
|
(I.R.S. Employer Identification Number) |
30142 Wixom Road
Wixom, Michigan 48393
(248) 960-9009
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrants Principal
Executive Offices)
Robert L. Chioini
President and Chief Executive Officer
30142 Wixom Road
Wixom, Michigan 48393
(248) 960-9009
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)
Copy to:
Mark A. Metz
Dykema Gossett PLLC
400 Renaissance Center
Detroit, Michigan 48243
Telephone: (313) 568-5434
Approximate date of commencement of proposed sale to the public: From time to time after the
effective date hereof.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following box. þ
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated filer o |
Accelerated filer þ |
Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company o |
CALCULATION OF REGISTRATION FEE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount |
|
|
Proposed Maximum |
|
|
Proposed Maximum |
|
|
Amount of |
|
|
Title of each class of |
|
|
To be |
|
|
Offering Price Per |
|
|
Aggregate Offering |
|
|
Registration |
|
|
securities to be registered |
|
|
Registered(1) |
|
|
Unit (2) |
|
|
Price |
|
|
Fee |
|
|
Common Stock, no par value
|
|
|
995,000
|
|
|
$7.56
|
|
|
$7,522,200
|
|
|
$419.74 |
|
|
|
|
|
(1) |
|
Consists of 995,000 shares of common stock issuable upon the exercise of outstanding warrants
previously issued to investors in private placements, and an indeterminate number of
additional shares of common stock as may from time to time be issued with respect to the
foregoing securities as a result of stock splits, stock dividends, reclassifications,
recapitalizations, combinations or similar events, which shares shall be deemed registered
hereunder pursuant to Rule 416 under the Securities Act. |
|
(2) |
|
Estimated solely for purposes of calculating the registration fee pursuant to Rule 457(c) and
(g) under the Securities Act, based on average of high and low price per share of the common
stock as reported on the Nasdaq Global Market on July 14, 2009. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary
to delay its effective date until the Registrant shall file a further amendment which specifically
states that this Registration Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this prospectus is not complete and may be changed. The selling shareholders
named in this prospectus may not sell these securities until the registration statement filed with
the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these
securities and the selling shareholders named in this prospectus are not soliciting offers to buy
these securities in any jurisdiction where the offer or sale is not permitted.
Subject to completion, dated July 20, 2009
PROSPECTUS
995,000 SHARES OF COMMON STOCK
This prospectus relates to resales of shares of our common stock, including shares of common stock
issuable upon the exercise of warrants, that we issued to the selling shareholders identified in
this prospectus (collectively, the Selling Shareholders) in connection with our private
placements of securities during 2007 and 2008. We will not receive any proceeds from the sale of
shares of our common stock by Selling Shareholders. Upon any exercise for cash of the warrants,
the warrant holders will pay us the exercise price of such warrants. We are paying certain
expenses incident to the registration of the shares.
The Selling Shareholders identified in this prospectus, or their pledgees, donees, transferees or
other successors-in-interest, may offer the shares from time to time through public or private
transactions at prevailing market prices, at prices related to prevailing market prices or at
privately negotiated prices.
Our common stock is listed on the Nasdaq Global Market and traded under the symbol RMTI. On July
17, 2009, the closing sale price of our common stock on Nasdaq was $8.38 per share. You are urged
to obtain current market quotations for the common stock.
Investing in our common stock involves a high degree of risk. See Risk Factors beginning on page 6.
Neither the Securities and Exchange Commission nor any state securities commission 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 is July 20, 2009.
TABLE OF CONTENTS
Rockwell Medical Technologies, Inc.s principal executive offices are located at 30142 Wixom Road,
Wixom, Michigan 48393, our telephone number at that address is (248) 960-9009 and our Internet
address is www.rockwellmed.com. The information on our Internet website is not incorporated by
reference in this prospectus, and you should not consider it to be a part of this document. Our
website address is included as an inactive textual reference only. Unless the context otherwise
requires references in this prospectus to Rockwell, we, us, and our refer to Rockwell
Medical Technologies, Inc.
We have not authorized anyone to provide you with information different from that contained or
incorporated by reference in this prospectus. The Selling Shareholders are offering to sell, and
seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are
permitted. The information contained in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or of any sale of common stock.
WHERE YOU CAN GET MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information with the
Securities and Exchange Commission (the SEC). You can inspect and copy such reports at the SECs
Public Reference Room at 100 F Street, N.E., Washington D.C. 20549. You may obtain information on
the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also
maintains an Internet site at www.sec.gov that contains reports, proxy and information statements
and other information regarding issuers that file electronically with the SEC, including Rockwell.
We have filed with the SEC a Registration Statement on Form S-3 to register the common shares that
are being offered in this prospectus. This prospectus is part of the Registration Statement. This
prospectus does not include all of the information contained in the Registration Statement. For
further information about us and the common shares offered in this prospectus, you should review
the Registration Statement. You can inspect or copy the Registration Statement, at prescribed
rates, at the SECs public reference facilities at the address listed above.
DOCUMENTS INCORPORATED BY REFERENCE
The SEC allows Rockwell to incorporate by reference the information it files with the SEC. This
permits us to disclose important information to you by referencing these filed documents. Any
information referenced in this way is considered part of this prospectus, and any information filed
with the SEC subsequent to this prospectus will automatically update and supersede this
information. Rockwell incorporates by reference the documents listed below which have been filed
with the SEC:
|
|
|
Annual Report on Form 10-K for the fiscal year ended December 31, 2008. |
|
|
|
|
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009. |
|
|
|
|
Current Reports on Form 8-K filed April 6, 2009 and June 1, 2009. |
|
|
|
|
The description of our common shares included in our prospectus, dated July 24, 1997,
included in our registration statement on Form SB-2 filed with the SEC on July 24, 1997,
under the caption Description of Securities on pages 34 through 38 of the prospectus and
incorporated by reference into our registration statement on Form 8-A filed with the SEC on
January 23, 1998, including any amendment or reports filed for the purpose of updating such
description. |
2
In addition, all documents filed by us under Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934 after the date of this prospectus but before the termination of this offering
are deemed to be incorporated by reference into this prospectus and will constitute a part of this
prospectus from the date of filing of those documents.
Any statement contained in a document incorporated by reference in this prospectus will be
considered to be modified or superseded for purposes of this prospectus to the extent that a
statement contained in this prospectus or in any subsequently filed document that is incorporated
by reference modifies or supersedes such statement. Any statement that is modified or superseded
will not, except as so modified or superseded, constitute a part of this prospectus.
Rockwell will provide without charge, upon written or oral request, a copy of any or all of the
documents which are incorporated by reference in this prospectus, including any exhibits which are
specifically incorporated by reference into such documents. Requests should be directed to Thomas
E. Klema, Secretary, at our principal executive offices, located at 30142 Wixom Road, Wixom,
Michigan 48393 (telephone number: (248) 960-9009).
3
PROSPECTUS SUMMARY
This summary highlights important features of this offering and the information included or
incorporated by reference in this prospectus. This summary does not contain all of the information
that you should consider before investing in our common stock. You should read the entire
prospectus carefully, especially the risks of investing in our common stock discussed under Risk
Factors.
We manufacture hemodialysis concentrate solutions and dialysis kits, and we sell, distribute and
deliver these and other ancillary hemodialysis products primarily to hemodialysis providers in the
United States as well as internationally primarily in Latin America, Asia and Europe. Hemodialysis
duplicates kidney function in patients with failing kidneys also known as End Stage Renal Disease
(ESRD). ESRD is an advanced stage of chronic kidney disease characterized by the irreversible
loss of kidney function. Without properly functioning kidneys, a patients body cannot get rid of
excess water and toxic waste products. Without frequent and ongoing dialysis treatments, these
patients would not survive.
Our dialysis solutions (also known as dialysate) are used to maintain life, removing toxins and
replacing nutrients in the dialysis patients bloodstream. We have licensed and are currently
developing proprietary renal drug therapies for both iron-delivery and carnitine/vitamin-delivery,
utilizing dialysate as the delivery mechanism. Iron supplementation is routinely administered to
more than 90% of patients receiving treatment for anemia. We have licensed a drug therapy for the
delivery of iron supplementation for anemic dialysis patients which we refer to as dialysate iron
and more specifically as soluble ferric pyrophosphate (SFP). To realize a commercial benefit
from this therapy, and pursuant to the licensing agreement, we must complete clinical trials and
obtain U.S. Food and Drug Administration (FDA) approval to market iron supplemented dialysate.
We also plan to seek foreign market approval for this product. We believe this product will
substantially improve iron maintenance therapy and, if approved, will compete for the global market
for iron maintenance therapy. Based on reports from manufacturers of intravenous (IV) iron
products, the market size in the United States for IV iron therapy for all indications is
approximately $500 million per year. We estimate the global market for IV iron therapy is in
excess of $850 million per year. We cannot, however, give any assurance that this product will be
approved by the FDA, or, if approved, that it will be successfully marketed.
We have also entered into a licensing agreement related to a patent for the delivery of carnitine
and vitamins via our hemodialysis solutions. To realize a commercial benefit of this product we
must obtain regulatory approval of this product. We intend to add other renal therapies to our
pipeline in the future.
Hemodialysis patients generally receive their treatments at independent hemodialysis clinics or at
hospitals. A hemodialysis provider such as a hospital or a free standing clinic uses a dialysis
station to treat patients. A dialysis station contains a dialysis machine that takes concentrate
solutions primarily consisting of nutrients and minerals, such as our liquid concentrate solutions
or our concentrate powders mixed with purified water, and accurately dilutes those solutions with
purified water. The resulting solution known as dialysate, is then pumped through a device known
as a dialyzer (artificial kidney), while at the same time the patients blood is pumped through a
semi-permeable membrane within the dialyzer. Excess water and chemicals from the patients blood
pass through the membrane and are carried away in the dialysate while certain nutrients and
minerals in the dialysate penetrate the membrane and enter the patients blood to maintain proper
blood chemistry. Dialysate generally contains dextrose, sodium chloride, calcium, potassium,
magnesium, sodium bicarbonate and acetic acid. The patients physician chooses the formula
required for each patient based on each particular patients needs, although most patients receive
one of eight common formulations.
In addition to using concentrate solutions and chemical powders (which must be replaced for each
use for each patient), a dialysis provider also requires various other ancillary products such as
blood tubing, fistula needles, specialized custom kits, dressings, cleaning agents, filtration
salts and other supplies, many of which we sell.
Hemodialysis treatments are generally performed in independent clinics or hospitals with the
majority of dialysis services performed by regional and national for profit dialysis chains. We
estimate that there are approximately 5,000 Medicare-certified treatment clinics in the United
States. The two largest national for-profit dialysis chains service approximately 63% of the
domestic hemodialysis market. According to industry statistics published by the U.S. Renal Data
Systems, 345,000 patients in the United States were receiving dialysis treatments at the end of
2006. The domestic dialysis industry has experienced steady patient population growth over the
last two decades. In the last five years, the patient growth rate has averaged 4% per year.
Population segments with the highest incidence of ESRD are also among the fastest growing within
the U.S. population including the elderly, Hispanic and African-American population segments.
Recent U.S. demographic projections indicate that the incidence of ESRD is expected to increase in
the years ahead and is expected to exceed current incidence levels.
4
ESRD incidence rates vary by country with some higher and some lower than the United States. Based
on industry reports, the global ESRD population is estimated to be over 2 million and to be growing
at a rate of approximately 6% annually. The three major dialysis markets are the United States,
the European Union and Japan, which together represent between approximately 55-60% of the total
global treatments based on industry estimates.
Our strategy is to develop our dialysis concentrate and supply business and to develop drugs,
nutrients and vitamins to be delivered by our dialysis concentrate products. Our long term
objectives are to increase our market share, expand our product line, expand our geographical
selling territory and improve our profitability by implementing the following strategies:
|
|
|
increasing our revenues through new innovative products, such as our Dri-Sate® Dry
Acid Concentrate Mixing System and SteriLyte® Liquid Bicarbonate Concentrate, |
|
|
|
|
gaining FDA approval to market innovative products such as SFP, |
|
|
|
|
acting as a single source supplier to our customers for the concentrates, chemicals
and supplies necessary to support a hemodialysis providers operation, |
|
|
|
|
offering our customers a higher level of delivery and customer service by using our
own delivery vehicles and drivers, and |
|
|
|
|
expanding our market share in target regions, including regions where our proximity
to customers will provide us with a competitive cost advantage and allow us to provide
superior customer service levels. |
THE OFFERING
|
|
|
Common Stock offered by Selling Shareholders
|
|
995,000 shares of our common
stock issuable upon the
exercise of warrants. |
|
|
|
Use of proceeds
|
|
Proceeds received from the
issuance of shares upon
exercise of warrants will be
used for general corporate
purposes. We will not
receive any proceeds from the
sale of shares in this
offering by the Selling
Shareholders. |
|
|
|
Nasdaq Global Market symbol
|
|
RMTI |
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
We make forward-looking statements in this prospectus. Our forward-looking statements are subject
to risks and uncertainties and include information about our expectations and possible or assumed
future results of our operations. When we use words such as may, might, will, should,
believe, expect, anticipate, estimate, continue, predict, forecast, projected,
intend or similar expressions, or make statements regarding our intent, belief or current
expectations, we are making forward-looking statements. Our forward looking statements also
include, without limitation, statements about our competitors, statements regarding the timing and
costs of obtaining FDA approval of our new SFP product and statements regarding our anticipated
future financial condition, operating results, cash flows and business plans.
We claim the protection of the safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995 for all of our forward-looking statements. While we
believe that our forward looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements, which are based on information available to us on the date
of this prospectus. Because these forward-looking statements are based on estimates and
assumptions that are subject to significant business, economic and competitive uncertainties, many
of which are beyond our control or are subject to change, actual results could be materially
different. Factors that might cause such a difference include, without limitation, the risks and
uncertainties discussed in this prospectus, including under Risk Factors, and from time to time
in our reports filed with the Securities and Exchange Commission. Other factors not currently
anticipated may also materially and adversely affect our results of operations, cash flows and
financial position. We do not undertake, and expressly disclaim, any obligation to update or alter
any statements whether as a result of new information, future events or otherwise except as
required by law.
5
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the
risks and uncertainties described below before purchasing our common stock. The risks and
uncertainties described below are not the only ones facing our company. Additional risks and
uncertainties may also impair our business operations. If any of the following risks actually
occur, our business, financial condition or results of operations would likely suffer. In that
case, the trading price of our common stock could fall, and you may lose all or part of the money
you paid to buy our common stock.
RISKS RELATED TO OUR BUSINESS
The dialysis provider market is highly concentrated in national and regional dialysis chains that
account for the majority of our domestic revenue. Our business is substantially dependent on one
of our customers that accounts for a substantial portion of our sales. The loss of this customer
would have a material adverse affect on our results of operations and cash flow.
Our revenue is highly concentrated in a few customers and the loss of any of those customers could
adversely affect our results. One customer in particular accounted for 51% of our total sales
during 2008. If we were to lose this customer or our relationship with any of our other major
national and regional dialysis chain customers, it would have a substantial negative impact on our
cash flow and operating results and could have a detrimental impact on our ability to continue our
operations in their current form or to continue to execute our business strategy. If we lost a
substantial portion of our business, we would be required to take actions to conserve our cash
resources and to mitigate the impact of any such losses on our business operations.
We operate in a very competitive market against substantially larger competitors with greater
resources.
There is intense competition in the hemodialysis product market and our competitors are large
diversified companies which have substantially greater financial, technical, manufacturing,
marketing, research and development and management resources than we do. We may not be able to
successfully compete with these other companies. Our national competitors have historically used
product bundling and low pricing as marketing techniques to capture market share of the products we
sell and as we do not manufacture or sell the same breadth of products as our competitors, we may
be at a disadvantage in competing against their marketing strategies.
Our new drug product requires FDA approval and expensive clinical trials before it can be marketed.
We are seeking FDA approval for SFP, a drug used in the treatment of anemia. Obtaining FDA approval
for any drug is expensive and can take a long time. We may not be successful in obtaining FDA
approval for SFP. The FDA may change, expand or alter its requirements for testing which may
increase the scope, duration and cost of our clinical development plan. Clinical trials are
expensive and time consuming to complete, and we may not be able to raise or obtain sufficient
funds to complete the clinical trials to obtain marketing approval. Our clinical trials might not
prove successful. In addition, the FDA may order the temporary or permanent discontinuation of a
clinical trial at any time. Many products that undergo clinical trials are never approved for
patient use. Thus, it is possible that our new proprietary products may never be approved to be
marketed. If we are unable to obtain marketing approval, our entire investment in new products may
be worthless and our licensing rights could be forfeited.
Even if our new drug product is approved by the FDA it may not be successfully marketed.
Several drugs currently dominate treatment for iron deficiency and new drugs treating this
indication will have to compete against existing products. It may be difficult to gain market
acceptance of a new product. Nephrologists, anemia managers and dialysis chains may be slow to
change their clinical practice protocols for new products or may not change their protocols at all.
Dialysis providers are dependent upon government reimbursement practices for the majority of their
revenue. Even if we obtain FDA approval for our new product, there is no guarantee that our
customers would receive reimbursement for the new product, even though the current treatment method
is reimbursed by the government. Without such reimbursement, it is unlikely that our customers
would adopt a new treatment method. There is a risk that our new product may not receive
reimbursement or may not receive the same level of reimbursement that is currently in place.
We may not be successful in improving our gross profit margins and our business may remain
unprofitable.
A significant portion of our costs are for chemicals and fuel which are subject to pricing
volatility based on demand and are highly influenced by the overall level of economic activity.
Since 2007, we have experienced dramatic increases in our costs which we have not yet been able to
fully recover from our customers through price increases. While we have recently changed certain
vendors and
6
realized cost decreases in several of our key cost inputs, we may be subject to future cost
increases which may negatively impact our results if we are unable to recover those cost increases.
If we are unable to improve our gross profit margins by reducing our costs and increasing our
prices, our business may remain unprofitable
Our products are distribution-intensive, resulting in a high cost to deliver relative to the
selling prices of our products. The cost of diesel fuel represents a significant operating cost for
us. If oil costs increase or if oil prices spike upward, we may be unable to recover those
increased costs through higher pricing. Also, as we increase our business in certain markets and
regions, which are farther from our manufacturing facilities than we have historically served, we
may incur additional costs that are greater than the additional revenue generated from these
initiatives. Our customer mix may change to a less favorable customer base with lower gross profit
margins.
Our competitors have often used bundling techniques to sell a broad range of products and have
often offered low prices on dialysis concentrate products to induce customers to purchase their
other higher margin products, such as dialysis machines and dialyzers. It may be difficult for us
to raise prices due to these competitive pressures.
Our suppliers may increase their prices faster than we are able to raise our prices to offset such
increases. We may have limited ability to gain a raw material pricing advantage by changing vendors
for certain chemicals and packaging materials.
As we increase our manufacturing and distribution infrastructure we may incur costs for an
indefinite period that are greater than the incremental revenue we derive from these expansion
efforts.
We depend on government funding of healthcare.
Many of our customers receive the majority of their funding from the government and are
supplemented by payments from private health care insurers. Our customers depend on Medicare and
Medicaid funding to be viable businesses. If Medicare and Medicaid funding were to be materially
decreased, our customers would be severely impacted and could be unable to pay us.
We may not have sufficient cash to fund future growth or SFP development.
Our research and development plan for SFP is expected to result in significant cash outlays beyond
2009. We expect to spend approximately $4.0 million in 2009 on SFP product development and
approval. We believe we have adequate cash resources to fund the testing and regulatory approval
for SFP in 2009. However, for us to complete our Phase III clinical development plan we will need
to obtain additional funding. SFP development costs for Phase III and to obtain FDA approval are
projected from 2010 until approval to be $15 million or more. Also, if our current clinical trial
efforts do not achieve acceptable results, we may have to do more testing and, depending on the
scope and duration of any additional testing, our available cash resources may not be sufficient to
fund that additional testing.
We are likely to require additional capital in 2010. If conditions in the credit and equity markets
do not improve during 2009, we may be unable to obtain the financing we will need in future years
on terms we deem acceptable or in the best interests of our Company and our shareholders, or such
financing may not be available to us at all. If such financing is not available, we may have to
take action to conserve capital, such as alter our strategy, delay spending on development
initiatives or take other actions to conserve cash resources.
Orders from our international distributors may not result in recurring revenue.
Our revenue from international distributors may not recur consistently or may not recur at all.
Such revenue is often dependent upon government funding in those nations and there may be local,
regional or geopolitical changes that may impact funding of healthcare expenditures in those
nations.
We depend on key personnel.
Our success depends heavily on the efforts of Robert L. Chioini, our President and Chief Executive
Officer, Dr. Richard Yocum MD, our Vice President of Drug Development & Medical Affairs, and Thomas
E. Klema, our Chief Financial Officer, Secretary and Treasurer. Mr. Chioini is primarily
responsible for managing our sales and marketing efforts. Dr. Yocum is primarily responsible for
managing our product development efforts. None of our executive management are parties to a current
employment agreement with the Company. If we lose the services of Mr. Chioini, Dr. Yocum or Mr.
Klema, our business, product development efforts, financial condition and results of operations
could be adversely affected.
Our business is highly regulated.
The testing, manufacture and sale of the products we manufacture and distribute are subject to
extensive regulation by the FDA and by other federal, state and foreign authorities. Before medical
devices can be commercially marketed in the United States, the FDA must give either 510(k)
clearance or pre-market approval for the devices. If we do not comply with these requirements, we
may be subject
7
to a variety of sanctions, including fines, injunctions, seizure of products, suspension of
production, denial of future regulatory approvals, withdrawal of existing regulatory approvals and
criminal prosecution. Our business could be adversely affected by any of these actions.
Although our hemodialysis concentrates have been cleared by the FDA, it could rescind these
clearances and any new products or modifications to our current products that we develop could fail
to receive FDA clearance. If the FDA rescinds or denies any current or future clearances or
approvals for our products, we would be prohibited from selling those products in the United States
until we obtain such clearances or approvals. Our business would be adversely affected by any such
prohibition, any delay in obtaining necessary regulatory approvals, and any limits placed by the
FDA on our intended use. Our products are also subject to federal regulations regarding
manufacturing quality. In addition, our new products will be subject to review as a pharmaceutical
drug by the FDA. Changes in applicable regulatory requirements could significantly increase the
costs of our operations and may reduce our profitability if we are unable to recover any such cost
increases through higher prices.
We depend on contract research organizations and consultants to manage and conduct our clinical
trials and if they fail to follow our protocol or meet FDA regulatory requirements our clinical
trial data and results could be compromised causing us to delay our development plans or have to do
more testing than planned.
We utilize a contract research organization to conduct our clinical trials in accordance with a
specified protocol. We also contract with other third party service providers for clinical trial
material production, packaging and labeling, lab testing, data management services as well as a
number of other services. There can be no assurance that these organizations will fulfill their
commitments to us on a timely basis or that the accuracy and quality of the clinical data they
provide us will not be compromised by their failure to fulfill their obligations. If these service
providers do not perform as contracted, our development plans could be adversely affected.
Foreign approvals to market our new drug products may be difficult to obtain.
The approval procedures for the marketing of our new drug products in foreign countries vary from
country to country, and the time required for approval may be longer or shorter than that required
for FDA approval. Even after foreign approvals are obtained, further delays may be encountered
before products may be marketed. Many countries require additional governmental approval for price
reimbursement under national health insurance systems.
Additional studies may be required to obtain foreign regulatory approval. Further, some foreign
regulatory agencies may require additional studies involving patients located in their countries.
Health care reform could adversely affect our business.
The federal and state governments in the United States, as well as many foreign governments, from
time to time explore ways to reduce medical care costs through health care reform. Due to
uncertainties regarding the ultimate features of reform initiatives and their enactment and
implementation, we cannot predict what impact any reform proposal ultimately adopted may have on
the pharmaceutical and medical device industry or on our business or operating results.
We may not have sufficient products liability insurance.
As a supplier of medical products, we may face potential liability from a person who claims that he
or she suffered harm as a result of using our products. We maintain products liability insurance in
the amount of $3 million per occurrence and $3 million in the aggregate. We cannot be sure that it
will remain economical to retain our current level of insurance, that our current insurance will
remain available or that such insurance would be sufficient to protect us against liabilities
associated with our business. We may be sued, and we may have significant legal expenses that are
not covered by insurance. In addition, our reputation could be damaged by product liability
litigation and that could harm our marketing ability. Any litigation could also hurt our ability to
retain products liability insurance or make such insurance more expensive. Our business, financial
condition and results of operations could be adversely affected by an uninsured or inadequately
insured product liability claim in the future.
Our Board of Directors is subject to potential deadlock.
Our Board of Directors presently has four members, and under our bylaws, approval by a majority of
the Directors is required for many significant corporate actions. It is possible that our Board of
Directors may be unable to obtain majority approval in certain circumstances, which would prevent
us from taking action.
RISKS RELATED TO OUR COMMON STOCK
Shares eligible for future sale may affect the market price of our common shares.
We are unable to predict the effect, if any, that future sales of common shares, or the
availability of our common shares for future sales, will have on the market price of our common
shares from time to time. Sales of substantial amounts of our common shares
8
(including shares issued upon the exercise of stock options or warrants), or the possibility
of such sales, could adversely affect the market price of our common shares and also impair our
ability to raise capital through an offering of our equity securities in the future. As of December
31, 2008 an additional 1,204,169 shares may be issued upon exercise of outstanding warrants. In
addition, as of December 31, 2008, there were an additional 955,000 warrants that become
exercisable over the next two years. In the future, we may issue additional shares or warrants in
connection with investments, repayment of our debt or for other purposes considered advisable by
our Board of Directors. Any substantial sale of our common shares may have an adverse effect on the
market price of our common shares.
In addition, as of December 31, 2008, there were 3,121,364 shares issuable upon the exercise of
outstanding and exercisable stock options, 941,667 shares issuable upon the exercise of outstanding
stock options that are not yet exercisable and 435,000 additional shares available for grant under
our 2007 Long Term Incentive Plan. Additional grants were made in 2009. The market price of the
common shares may be depressed by the potential exercise of these options. The holders of these
options are likely to exercise them when we would otherwise be able to obtain additional capital on
more favorable terms than those provided by the options. Further, while the options are
outstanding, we may be unable to obtain additional financing on favorable terms.
The market price of our securities may be volatile.
The historically low trading volume of our common shares may also cause the market price of the
common shares to fluctuate significantly in response to a relatively low number of trades or
transactions.
Voting control and anti-takeover provisions reduce the likelihood that you will receive a takeover
premium.
As of December 31, 2008, our officers and directors beneficially owned approximately 23.2% of our
voting shares (assuming the exercise of exercisable options granted to such officers and
directors). Accordingly, they may be able to effectively control our affairs. Our shareholders do
not have the right to cumulative voting in the election of directors. In addition, the Board of
Directors has the authority, without shareholder approval, to issue shares of preferred stock
having such rights, preferences and privileges as the Board of Directors may determine. Any such
issuance of preferred stock could, under certain circumstances, have the effect of delaying or
preventing a change in control and may adversely affect the rights of holders of common shares,
including by decreasing the amount of earnings and assets available for distribution to holders of
common shares and adversely affect the relative voting power or other rights of the holders of the
common shares. In addition, we are subject to Michigan statutes regulating business combinations
which might also hinder or delay a change in control. Anti-takeover provisions that could be
included in the preferred stock when issued and the Michigan statutes regulating business
combinations, takeovers and control share acquisitions can have a depressive effect on the market
price of our common shares and can limit shareholders ability to receive a premium on their shares
by discouraging takeover and tender offers.
Our directors serve staggered three-year terms, and directors may not be removed without cause. Our
Articles of Incorporation also set the minimum and maximum number of directors constituting the
entire Board at three and fifteen, respectively, and require approval of holders of a majority of
our voting shares to amend these provisions. These provisions could have an anti-takeover effect by
making it more difficult to acquire us by means of a tender offer, a proxy contest or otherwise, or
to remove incumbent directors. These provisions could delay, deter or prevent a tender offer or
takeover attempt that a shareholder might consider in his or her best interests, including those
attempts that might result in a premium over the market price for the common shares.
We do not anticipate paying dividends in the foreseeable future.
Since inception, we have not paid any cash dividend on our common shares and do not anticipate
paying such dividends in the foreseeable future. The payment of dividends is within the discretion
of our Board of Directors and depends upon our earnings, capital requirements, financial condition
and requirements, future prospects, restrictions in future financing agreements, business
conditions and other factors deemed relevant by the Board. We intend to retain earnings and cash
resources, if any, to finance our operations and, therefore, it is highly unlikely we will pay cash
dividends.
9
USE OF PROCEEDS
Upon any exercise for cash of the warrants, the warrant holders will pay us the exercise price of
the warrants as set forth in the following table. We will use any cash we receive upon the
exercise of the warrants for general corporate purposes. There is no assurance that all or any of
the warrants will be exercised prior to their expiration nor any assurance of the timing of the
receipt of exercise proceeds. Assuming that all of the warrants are exercised for cash, we expect
to receive proceeds of approximately $5.2 million. We will not receive any proceeds from the sale
of shares by the Selling Shareholders.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Per Share |
|
|
|
|
Name of Warrant Holder |
|
Underlying Warrants |
|
|
Exercise Price |
|
|
Total |
|
Emerald Asset Advisors, LLC |
|
|
300,000 |
|
|
|
1.99 |
|
|
$ |
597,000 |
|
Emerald Asset Advisors, LLC |
|
|
200,000 |
|
|
|
4.54 |
|
|
|
908,000 |
|
RJ Aubrey IR Services LLC |
|
|
60,000 |
|
|
|
6.50 |
|
|
|
390,000 |
|
Emerald Asset Advisors, LLC |
|
|
200,000 |
|
|
|
7.00 |
|
|
|
1,400,000 |
|
Lions Gate Capital |
|
|
90,000 |
|
|
|
7.00 |
|
|
|
630,000 |
|
Lions Gate Capital |
|
|
45,000 |
|
|
|
7.50 |
|
|
|
337,500 |
|
Capitol Securities Management, Inc.* |
|
|
100,000 |
|
|
|
9.00 |
|
|
|
900,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
995,000 |
|
|
|
|
|
|
$ |
5,162,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Warrant initially issued to Capitol Securities Management, Inc., a portion of which was
transferred to five Selling Shareholders. |
The Selling Shareholders will pay any underwriting discounts and commissions and expenses incurred
by the Selling Shareholders for brokerage, accounting, tax or legal services or any other expenses
incurred by the Selling Shareholders in disposing of the shares. We will bear all other costs,
fees and expenses incurred in effecting the registration of the shares covered by this prospectus,
including, without limitation, all registration and filing fees, Nasdaq Global Market listing fees
and fees and expenses of our counsel and our accountants.
SELLING SHAREHOLDERS
The shares of common stock being sold by the Selling Shareholders consist of 995,000 shares of our
common stock that are issuable upon exercise of warrants we issued to the parties listed in the
table above in private placements during 2007 and 2008. Throughout this prospectus, when we refer
to the Selling Shareholders, we mean the persons listed in the table below, as well as the
pledgees, donees, assignees, transferees, successors and others who later hold any of the Selling
Shareholders interests, and when we refer to the shares of our common stock being offered by this
prospectus, we are referring to the shares of our common stock issuable upon the exercise of the
warrants issued in the private placements, collectively, unless otherwise indicated.
In connection with the registration rights we granted in connection with the issuance of the
warrants, we filed with the SEC a registration statement on Form S-3, of which this prospectus
forms a part, with respect to the resale or other disposition of the shares of common stock offered
by this prospectus or interests therein from time to time on the Nasdaq Global Market, in privately
negotiated transactions or otherwise.
The actual number of shares of common stock covered by this prospectus, and included in the
registration statement of which this prospectus forms a part, includes additional shares of common
stock that may be issued with respect to the shares of common stock described herein as a result of
stock splits, stock dividends, reclassifications, recapitalizations, combinations or similar
events.
10
The table below sets forth, to our knowledge, information about the Selling Shareholders as of June
19, 2009. Beneficial ownership is determined in accordance with the rules of the SEC and includes
voting or investment power with respect to shares of our common stock. The number representing the
number of shares of common stock beneficially owned prior to the offering for each Selling
Shareholder includes (i) all shares held by a Selling Shareholder, as well as (ii) all options,
warrants, or other derivative securities which are exercisable within 60 days after June 19, 2009,
including the warrants referenced in this prospectus, held by such Selling Shareholder. The
percentages of shares owned after the offering are based on 14,132,712 shares of our common stock
outstanding as of April 30, 2009. Unless otherwise indicated below, to our knowledge, all persons
named in this table have sole voting and investment power with respect to their shares of common
stock, except to the extent authority is shared by spouses under applicable law. The inclusion of
any shares in this table does not constitute an admission of beneficial ownership by the person
named below.
We do not know when or in what amounts a Selling Shareholder may offer shares for sale. The Selling
Shareholders might not sell any or all of the shares offered by this prospectus. Because the
Selling Shareholders may offer all or some of the shares pursuant to this offering, and because
there are currently no agreements, arrangements or understandings with respect to the sale of any
of the shares, we cannot estimate the number of the shares that will be held by the Selling
Shareholders after completion of the offering. For purposes of the table below, we have assumed
that, after completion of the offering, none of the shares covered by this prospectus will be held
by the Selling Shareholders.
The Selling Shareholders may have sold or transferred, in transactions exempt from the registration
requirements of the Securities Act, some or all of their shares of common stock since the date on
which the information in the table below is presented. Information about the Selling Shareholders
may change over time.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Shares of Common Stock |
|
|
Shares of Common Stock |
|
of Common |
|
to be |
|
|
Beneficially Owned Prior |
|
Stock |
|
Beneficially Owned After |
|
|
to Offering |
|
Being |
|
Offering |
Name of Selling Shareholder |
|
Number |
|
Percentage |
|
Offered |
|
Number |
|
Percentage |
Emerald Asset Advisors, LLC |
|
|
0 |
|
|
|
* |
% |
|
|
700,000 |
(1) |
|
|
0 |
|
|
|
0 |
|
Capitol Securities Management, Inc. |
|
|
5,000 |
(2) |
|
|
* |
% |
|
|
5,000 |
|
|
|
0 |
|
|
|
0 |
|
John Rick |
|
|
42,000 |
(3) |
|
|
* |
% |
|
|
42,000 |
|
|
|
0 |
|
|
|
0 |
|
Mitchell Pizzirusso |
|
|
20,000 |
(4) |
|
|
* |
% |
|
|
20,000 |
|
|
|
0 |
|
|
|
0 |
|
Walter Ries |
|
|
10,000 |
(5) |
|
|
* |
% |
|
|
8,000 |
|
|
|
2,000 |
|
|
|
* |
% |
Raymond Meyers |
|
|
12,500 |
(6) |
|
|
* |
% |
|
|
12,500 |
|
|
|
0 |
|
|
|
0 |
|
Vincent Pace |
|
|
12,500 |
(7) |
|
|
* |
% |
|
|
12,500 |
|
|
|
0 |
|
|
|
0 |
|
RJ Aubrey IR Services LLC |
|
|
118,385 |
(8) |
|
|
* |
% |
|
|
60,000 |
|
|
|
58,385 |
|
|
|
* |
% |
Lions Gate Capital |
|
|
135,000 |
(9) |
|
|
* |
% |
|
|
135,000 |
|
|
|
0 |
|
|
|
0 |
|
|
|
|
* |
|
Less than one percent. |
|
(1) |
|
Consists of 700,000 shares of common stock issuable to Emerald Asset Advisors, LLC
(Emerald) upon the exercise of warrants by Emerald. Michael Xirinachs is the sole managing
partner of Emerald. Michael Xirinachs expressly disclaims beneficial ownership of the
securities, other than to the extent of his pecuniary interest therein. |
|
(2) |
|
Consists of 5,000 shares of common stock issuable to Capitol Securities Management, Inc.
(Capitol) upon the exercise of warrants by Capitol. Mark Hamby is the President of Capitol
and Joseph Jianos is the Chief Executive Officer of Capitol. Messrs. Hamby and Jianos
expressly disclaim beneficial ownership of the securities, other than to the extent of their
pecuniary interest therein. The ownership information shown reflects the transfer of warrants
by Capitol and is current as of July 17, 2009. |
|
(3) |
|
Consists of 42,000 shares of common stock issuable to John Rick upon the exercise of warrants
by Mr. Rick. The ownership information shown reflects the transfer of warrants by Capitol and
is current as of July 17, 2009. |
|
(4) |
|
Consists of 20,000 shares of common stock issuable to Mitchell Pizzirusso upon the exercise
of warrants by Mr. Pizzirusso. The |
11
|
|
|
|
|
ownership information shown reflects the transfer of warrants by Capitol and is current as of July
17, 2009. |
|
(5) |
|
Consists of 8,000 shares of common stock issuable to Walter Ries upon the exercise of
warrants by Mr. Ries and 2,000 shares of common stock held in a brokerage account. The
ownership information shown reflects the transfer of warrants by Capitol and is current as of
July 17, 2009. |
|
(6) |
|
Consists of 12,500 shares of common stock issuable to Mr. Meyers upon the exercise of
warrants by Mr. Meyers. The ownership information shown reflects the transfer of warrants by
Capitol and is current as of July 17, 2009. |
|
(7) |
|
Consists of 12,500 shares of common stock issuable to Mr. Pace upon the exercise of warrants
by Mr. Pace. The ownership information shown reflects the transfer of warrants by Capitol and
is current as of July 17, 2009. |
|
(8) |
|
Consists of 38,385 shares of common stock owned by RJ Aubrey IR Services LLC (RJ Aubrey)
and 80,000 shares of common stock issuable upon the exercise of currently exercisable warrants
by RJ Aubrey. Ronald J. Aubrey is the sole member of RJ Aubrey and expressly disclaims
beneficial ownership of the securities, other than to the extent of his pecuniary interest
therein. |
|
(9) |
|
Consists of 135,000 shares of common stock issuable upon the exercise of warrants by Lions
Gate Capital (Lions Gate). Jim Braseth and Brad Holt are the managing members of Lions Gate
and may be deemed to share voting and dispositive power over the shares beneficially owned by
Lions Gate. Each of the above persons expressly disclaims beneficial ownership of the
securities, other than to the extent of his pecuniary interest therein. |
Relationships with Selling Shareholders
Each of the Selling Shareholders acts or has acted as a non-employee consultant providing various
advisory services, including without limitation investor relations consulting services, introducing
the Company to potential licensing partners and acquisition candidates and acting as a liaison to
the equity investment community. Except as otherwise disclosed in the preceding sentence, none of
the Selling Shareholders has held any position or office with us or our affiliates within the last
three years or has had a material relationship with us or any of our predecessors or affiliates
within the past three years.
PLAN OF DISTRIBUTION
Selling Shareholders
The Selling Shareholders of the common shares covered by this prospectus or any of their pledgees,
donees, transferees and successors-in-interest may, from time to time, sell any or all of their
shares of common shares on any stock exchange market or trading facility on which the shares are
traded or in private transactions. These sales may be at fixed, negotiated or market prices. The
Selling Shareholders may use any one or more of the following methods when selling shares:
|
|
|
ordinary brokerage transactions and transactions in which the broker dealer solicits
purchasers; |
|
|
|
|
block trades in which the broker-dealer will attempt to sell the shares as agent but
may position and resell a portion of the block as principal to facilitate the transaction; |
|
|
|
|
purchases by a broker-dealer as principal and resale by the broker-dealer for its
account; |
|
|
|
|
an exchange distribution in accordance with the rules of the applicable exchange; |
|
|
|
|
privately negotiated transactions; |
|
|
|
|
settlement of short sales entered into after the date of this prospectus; |
|
|
|
|
broker-dealers may agree with the Selling Shareholder to sell a specified number of
such shares at a stipulated price per share; |
|
|
|
|
a combination of any such methods of sale; |
|
|
|
|
through the writing or settlement of options or other hedging transactions, whether
through an options exchange or otherwise; or |
12
|
|
|
any other method permitted pursuant to applicable law. |
The Selling Shareholders may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus. Broker-dealers engaged by the Selling Shareholders
may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive
commissions or discounts from the Selling Shareholders (or, if any broker-dealer acts as agent for
the purchaser of shares, from the purchaser) in amounts to be negotiated, but, except as set forth
in a supplement to this prospectus, in the case of an agency transaction not in excess of a
customary brokerage commission in compliance with NASDR Rule 2440; and in the case of a principal
transaction a markup or markdown in compliance with NASDR IM-2440.
In connection with the sale of the common shares or interests therein, the Selling Shareholders may
enter into hedging transactions with broker-dealers or other financial institutions, which may in
turn engage in short sales of the common shares in the course of hedging the positions they assume.
The Selling Shareholders may also, on or after the date of this prospectus, sell the common shares
short and deliver these securities to close out their short positions, or loan or pledge the common
shares to broker-dealers that in turn may sell these securities. The Selling Shareholders may also
enter into option or other transactions with broker-dealers or other financial institutions or the
creation of one or more derivative securities which require the delivery to such broker-dealer or
other financial institution of shares offered by this prospectus, which shares such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended
to reflect such transaction).
Any broker-dealers or agents that are involved in selling or distributing the shares may be deemed
to be underwriters within the meaning of the Securities Act in connection with such sales. In
such event, any commissions received by such broker-dealers or agents and any profit on the resale
of the shares purchased by them may be deemed to be underwriting commissions or discounts under the
Securities Act. Each Selling Shareholder has informed the Company that it does not have any written
or oral agreement, arrangement or understanding, directly or indirectly, with any underwriter,
broker-dealer or other person to distribute or resell the common shares.
Under applicable rules and regulations under the Securities Exchange Act of 1934, any person
engaged in the distribution of the resale shares may not simultaneously engage in market making
activities with respect to the common shares for a period of two business days prior to the
commencement of the distribution. In addition, the Selling Shareholders will be subject to
applicable provisions of the Exchange Act and the rules and regulations thereunder, including
Regulation M, which may limit the timing of purchases and sales of shares of the common shares by
the Selling Shareholders or any other person. We will make copies of this prospectus available to
the Selling Shareholders and have informed them of the need to deliver a copy of this prospectus to
each purchaser at or prior to the time of the sale.
Warrants
In 2007 and 2008, we issued warrants to purchase common shares pursuant to compensation
arrangements with four non-employee consultants who provide (or provided) services to us, including
providing investor relations consulting services and introducing the Company to potential licensing
partners and acquisition candidates and acting as a liaison to the equity investment community. The
exercise price and the number of shares of common stock purchasable upon exercise of the warrants
are subject to adjustment in certain events including: (a) a stock dividend payable in common
stock, stock split, or subdivision of our common stock; and (b) reclassification of our common
stock or any reorganization, consolidation, merger, or sale, lease, license, exchange or other
transfer of all or substantially all of the business and/or assets of the Company.
The following description is a summary of material provisions of the warrants the underlying shares
of which are covered by this prospectus. It does not restate the terms of the warrants in their
entirety. We urge you to read the forms of warrant because they, and not this description, define
the rights of the holders of the warrants.
As of October 3, 2007, we entered into a consulting agreement with Lions Gate Capital pursuant to
which we have issued warrants to acquire 135,000 common shares. The warrants were earned at the
rate of 15,000 warrants per month of service beginning October 3, 2007 and continuing on the first
day of each month thereafter from November 1, 2007 through June 1, 2008. The first 90,000 warrants
that were earned have an exercise price of $7.00 per share and the remaining 45,000 warrants have
an exercise price of $7.50 and in each case are exercisable for cash. The warrants expire at the
close of business on October 3, 2011. These warrants become exercisable on the first anniversary of
the date on which they are earned and may be exercised in whole or in part at any time until their
expiration. The warrants are subject to customary restrictions on transfer.
On May 28, 2008, we entered into an advisory agreement with Capitol Securities Management, Inc.
pursuant to which we issued warrants to acquire 100,000 common shares. The warrants were immediately earned and became
exercisable on May 28, 2009. The
13
warrants will expire on the earlier of (i) May 28, 2012, or (ii) the termination of the agreement
prior to May 28, 2009 (A) by us due to a material breach of the agreement by the consultant or (B)
by the consultant. The warrants have an exercise price of $9.00 per share and may be exercised on a
cashless basis or for cash. The warrant holder is generally prohibited from transferring the
warrants except to an affiliate who is an accredited investor and who agrees to be bound by the
terms of the advisory agreement and warrants.
On September 30, 2008, we entered into an advisory agreement RJ Aubrey IR Services LLC pursuant to
which we issued warrants to acquire 60,000 common shares. The warrants are earned in 20,000 share
increments on September 30, 2008, January 1, 2009 and July 1, 2009. To the extent earned, the
warrants become exercisable on January 1, 2010 and will expire on September 30, 2012. Upon a
termination of the agreement (A) by us due to a material breach of the agreement by the consultant
or (B) by the consultant, any unearned warrants at the time of such termination will expire. The
warrants have an exercise price of $6.50 per share and may be exercised on a cashless basis or for
cash. The warrant holder is generally prohibited from transferring the warrants except to an
affiliate who is an accredited investor and who agrees to be bound by the terms of the advisory
agreement and warrants.
In November 2008, we entered into an advisory agreement, as amended, with Emerald Asset Advisors,
LLC pursuant to which we issued warrants to acquire a total of 700,000 common shares. All of the
warrants were immediately earned. Warrants to purchase 300,000 common shares at an exercise price
of $1.99 per share will become exercisable on November 5, 2009, and will expire on the earlier of
(i) November 5, 2011, or (ii) the termination of the agreement prior to November 5, 2009 (A) by us
due to a material breach of the agreement by the consultant or (B) by the consultant. Warrants to
purchase 400,000 common shares will become exercisable on November 5, 2010, and will expire on the
earlier of (i) November 5, 2011, or (ii) the termination of the agreement prior to November 5, 2010
(A) by us due to a material breach of the agreement by the consultant or (B) by the consultant.
200,000 of these warrants have an exercise price of $4.54, and the remaining 200,000 have an
exercise price of $7.00 per share. The warrants are exercisable only for cash. The warrant holder
is generally prohibited from transferring the warrants except to an affiliate who is an accredited
investor and who agrees to be bound by the terms of the advisory agreement and warrants.
Expenses
The Company is bearing the expenses incident to the registration of the shares. The following
table sets forth the estimated amounts of expenses to be borne by the Company in connection with
the issuance and distribution of the common shares being registered, other than underwriting
discounts and commissions (which will be borne by the Selling Shareholders):
|
|
|
|
|
Securities and Exchange Commission registration fee |
|
$ |
420 |
|
Accounting fees and expenses |
|
|
3,000 |
|
Legal fees and expenses |
|
|
30,000 |
|
Transfer agents and registrars fees and expenses |
|
|
3,000 |
|
Miscellaneous expenses |
|
|
13,580 |
|
|
|
|
|
Total |
|
$ |
50,000 |
|
None of these expenses will be borne by the Selling Shareholders. All of these expenses, except
the Securities and Exchange Commission registration fee, are estimated.
LEGAL MATTERS
The validity of the issuance of the common stock offered by this prospectus will be passed upon for
us by Dykema Gossett PLLC.
EXPERTS
The financial statements incorporated in this prospectus by reference from the Companys Annual
Report on Form 10-K for the year ended December 31, 2008 have been audited by Plante & Moran, PLLC,
independent auditors, as stated in their report which is incorporated in this prospectus by
reference, and have been so incorporated in reliance upon the report of such firm given upon their
authority as experts in accounting and auditing.
14
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the various expenses to be incurred in connection with the sale and
distribution of the securities being registered hereby, all of which will be borne by Rockwell
Medical Technologies, Inc. (except any underwriting discounts and commissions and expenses incurred
by the Selling Shareholders for brokerage, accounting, tax or legal services or any other expenses
incurred by the Selling Shareholders in disposing of the shares). All amounts shown are estimates
except the SEC registration fee.
|
|
|
|
|
SEC registration fee |
|
$ |
420 |
|
Legal fees and expenses |
|
|
30,000 |
|
Accounting fees and expenses |
|
|
3,000 |
|
Transfer agents and registrars fees and expenses |
|
|
3,000 |
|
Miscellaneous expenses |
|
|
13,580 |
|
|
|
|
|
Total expenses |
|
$ |
50,000 |
|
Item 15. Indemnification of Directors and Officers.
The Michigan Business Corporation Act, as amended (the MBCA), authorizes a Michigan corporation
under specified circumstances to indemnify its directors and officers (including reimbursement for
expenses incurred). The provisions of the Companys Bylaws relating to indemnification of directors
and officers generally provide that present and former directors and officers will be indemnified
to the fullest extent permissible under Michigan law. The provision also provides for the
advancement of litigation expenses at the request of a director or officer.
The MBCA also permits Michigan corporations to limit the personal liability of directors for a
breach of their fiduciary duty. The provisions of the Companys Articles of Incorporation limit
director liability to the maximum extent currently permitted by Michigan law. Michigan law allows a
corporation to provide in its articles of incorporation that a director of the corporation will not
be personally liable to the corporation or its shareholders for monetary damages for breach of
fiduciary duty as a director, except for liability for specified acts.
Section 567 of the MBCA authorizes the Company to purchase and maintain insurance on behalf of a
person who is or was a director, officer, employee or agent of the Company or who serves at the
request of the Company as a director, officer, partner, trustee, employee or agent of another
enterprise, whether or not the Company would have the power to indemnify him or her under the
Bylaws or the laws of the State of Michigan. The Company maintains a directors and officers
insurance policy.
Item 16. Exhibits.
|
|
|
EXHIBIT |
|
|
NUMBER |
|
DESCRIPTION |
4.1
|
|
Warrant issued to RJ Aubrey IR Services LLC as of September 30, 2008 |
4.2
|
|
Warrant issued to Lions Gate Capital as of October 3, 2007 |
4.3
|
|
Warrant issued to Capitol Securities Management, Inc. as of May 28, 2008 |
4.4
|
|
Warrant issued to Emerald Asset Advisors, LLC |
4.5
|
|
Form of Warrant issued to Messrs. Rick, Pizzirusso, Ries, Meyers and Pace as of July 17, 2009 |
5.1
|
|
Opinion of Dykema Gossett PLLC |
10.17
|
|
Consulting Agreement, dated as of October 3, 2007, filed as an exhibit to the Companys
Current Report on Form 8-K on October 9, 2007 and incorporated herein by reference |
10.24
|
|
Advisory Agreement dated May 28, 2008 between the Company and Capitol Securities Management,
Inc., filed as an exhibit to the quarterly report on Form 10-Q filed on August 12, 2008 and
incorporated herein by reference |
10.26
|
|
Advisory Agreement dated September 30, 2008 between the Company and RJ Aubrey IR Services
LLC, filed as an exhibit to the quarterly report on Form 10-Q filed on November 13, 2008 and
incorporated herein by reference |
10.27
|
|
Advisory Agreement dated November 5, 2008 between the Company and Emerald Asset Advisors,
LLC, |
II-1
|
|
|
EXHIBIT |
|
|
NUMBER |
|
DESCRIPTION |
|
|
filed as an exhibit to the quarterly report on Form 10-Q filed on November 13, 2008 and
incorporated herein by reference |
10.29
|
|
Amendment to Advisory Agreement dated November 21, 2008 between the Company and Emerald
Asset Advisors, LLC, filed as an exhibit to the annual report on Form 10-K filed on March
16, 2009 and incorporated herein by reference |
23.1
|
|
Consent of Plante & Moran, PLLC |
23.2
|
|
Consent of Dykema Gossett PLLC, included in Exhibit 5.1 filed herewith |
24.1
|
|
Power of Attorney of Ronald D. Boyd |
24.2
|
|
Power of Attorney of Kenneth L. Holt |
24.3
|
|
Power of Attorney of Patrick J. Bagley |
Item 17. Undertakings.
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment
to this Registration Statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as
amended (the Securities Act);
(ii) To reflect in the prospectus any facts or events arising after the effective date of this
Registration Statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in this Registration
Statement. Notwithstanding the foregoing, any increase or decrease in the volume of securities
offered (if the total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum offering range may
be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than 20 percent change in the maximum
aggregate offering price set forth in the Calculation of Registration Fee table in the effective
Registration Statement; and
(iii) To include any material information with respect to the plan of distribution not previously
disclosed in this Registration Statement or any material change to such information in this
Registration Statement; provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) do not
apply if the information required to be included in a post-effective amendment by those paragraphs
is contained in periodic reports filed with or furnished to the Commission by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the
Exchange Act), that are incorporated by reference in this Registration Statement, or is contained
in a form of prospectus filed pursuant to Rule 424(b) that is part of this Registration Statement.
(2) That, for the purposes of determining any liability under the Securities Act, each
post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at the time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being
registered which remain unsold at the termination of the offering.
Each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an
offering, shall be deemed to be part of and included in the registration statement as of the date
it is first used after effectiveness. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement or prospectus that
is part of the registration statement will, as to a purchaser with a time of contract of sale prior
to such first use, supersede or modify any statement that was made in the registration statement or
prospectus that was part of the registration statement or made in any such document immediately
prior to such date of first use.
The undersigned registrant hereby undertakes that, for purposes of determining any liability under
the Securities Act, each filing of the registrants annual report pursuant to Section 13(a) or
15(d) of the Exchange Act that is incorporated by reference in this Registration Statement shall be
deemed to be a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to
directors, officers and controlling persons of the Registrant pursuant to the indemnification
provisions described herein, or otherwise, the Registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
II-2
Registrant of expenses incurred or paid by a director, officer or controlling person of the
Registrant in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being registered, the
Registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by it is against public policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies
that it has reasonable grounds to believe that it meets all of the requirements for filing on Form
S-3 and has duly caused this Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Wixom, State of Michigan, on July 20, 2009.
|
|
|
|
|
ROCKWELL MEDICAL TECHNOLOGIES, INC.
|
|
By: |
/s/ Robert L. Chioini
|
|
|
Robert L. Chioini |
|
|
President, Chief Executive Officer, and Chairman of the Board |
|
|
SIGNATURES AND POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement
has been signed by the following persons in the capacities and on the dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Robert L. Chioini
Robert L. Chioini
|
|
President, Chief Executive
Officer and Chairman of
the Board (Principal
Executive Officer)
|
|
July 20, 2009 |
|
|
|
|
|
/s/ Thomas E. Klema
Thomas E. Klema
|
|
Vice President of Finance,
Chief Financial Officer,
Treasurer, and Secretary
(Principal Financial
Officer and Principal
Accounting Officer)
|
|
July 20, 2009 |
|
|
|
|
|
*
|
|
Director
|
|
July 20, 2009 |
Ronald D. Boyd |
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
July 20, 2009 |
Kenneth L. Holt |
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
July 20, 2009 |
Patrick J. Bagley |
|
|
|
|
|
|
|
|
|
|
|
/s/ Thomas E. Klema
|
|
* By Thomas E. Klema, attorney in fact |
|
|
|
II-4
EXHIBIT INDEX
|
|
|
EXHIBIT |
|
|
NUMBER |
|
DESCRIPTION |
4.1
|
|
Warrant issued to RJ Aubrey IR Services LLC as of September 30, 2008 |
4.2
|
|
Warrant issued to Lions Gate Capital as of October 3, 2007 |
4.3
|
|
Warrant issued to Capitol Securities Management, Inc. as of May 28, 2008 |
4.4
|
|
Warrant issued to Emerald Asset Advisors, LLC |
4.5
|
|
Form of Warrant issued to Messrs. Rick, Pizzirusso, Ries, Meyers and Pace as of July 17, 2009 |
5.1
|
|
Opinion of Dykema Gossett PLLC |
10.17
|
|
Consulting Agreement, dated as of October 3, 2007, filed as an exhibit to the Companys
Current Report on Form 8-K on October 9, 2007 and incorporated herein by reference |
10.24
|
|
Advisory Agreement dated May 28, 2008 between the Company and Capitol Securities Management,
Inc., filed as an exhibit to the quarterly report on Form 10-Q filed on August 12, 2008 and
incorporated herein by reference |
10.26
|
|
Advisory Agreement dated September 30, 2008 between the Company and RJ Aubrey IR Services
LLC, filed as an exhibit to the quarterly report on Form 10-Q filed on November 13, 2008 and
incorporated herein by reference |
10.27
|
|
Advisory Agreement dated November 5, 2008 between the Company and Emerald Asset Advisors,
LLC, filed as an exhibit to the quarterly report on Form 10-Q filed on November 13, 2008 and
incorporated herein by reference |
10.29
|
|
Amendment to Advisory Agreement dated November 21, 2008 between the Company and Emerald
Asset Advisors, LLC, filed as an exhibit to the annual report on Form 10-K filed on March
16, 2009 and incorporated herein by reference |
23.1
|
|
Consent of Plante & Moran, PLLC |
23.2
|
|
Consent of Dykema Gossett PLLC, included in Exhibit 5.1 filed herewith |
24.1
|
|
Power of Attorney of Ronald D. Boyd |
24.2
|
|
Power of Attorney of Kenneth L. Holt |
24.3
|
|
Power of Attorney of Patrick J. Bagley |
II-5