424b5
Filed
Pursuant to Rule 424(b)(5)
Registration No. 333-165037
This prospectus supplement,
together with the accompanying short form base shelf prospectus
dated March 12, 2010 to which it relates, as amended or
supplemented and each document incorporated or deemed to be
incorporated by reference in this prospectus supplement and the
accompanying prospectus, constitutes a public offering of these
securities only in those jurisdictions where such securities may
be lawfully offered for sale and therein only by persons
permitted to sell such securities. No securities regulatory
authority has expressed an opinion about these securities and it
is an offense to claim otherwise.
PROSPECTUS SUPPLEMENT NO. 3
(TO PROSPECTUS DATED MARCH 12, 2010)
Up to 12,500,000 Common
Shares
Aeterna Zentaris Inc. (we, us or the
Company) has entered into an At Market Issuance
Sales Agreement (the Sales Agreement) with McNicoll,
Lewis & Vlak LLC (MLV), relating to our
common shares (the Common Shares) offered by this
prospectus supplement and the accompanying prospectus. In
accordance with the terms of the Sales Agreement, we may offer
and sell up to a maximum of 12,500,000 of our Common Shares from
time to time through MLV, as agent.
Our Common Shares are listed on the NASDAQ Global Market
(NASDAQ) under the symbol AEZS and on
the Toronto Stock Exchange (TSX) under the symbol
AEZ. On February 18, 2011, the last reported sales
price of our Common Shares on NASDAQ was $1.70 per share and on
TSX was C$1.67 per share. There is no arrangement for funds to
be received in escrow, trust or similar arrangement.
Upon delivery of a placement notice by us, if any, MLV may sell
the Common Shares, in the United States only, by any method
permitted by law deemed to be an at the market
offering as defined in Rule 415 of the Securities Act of
1933, as amended (the Securities Act), including,
without limitation, sales made directly on NASDAQ, or on any
other existing trading market for the Common Shares in the
United States. MLV will make all sales using commercially
reasonable efforts consistent with its normal sales and trading
practices and on mutually agreed upon terms between MLV and us.
The Common Shares will be distributed at market prices
prevailing at the time of the sale of such Common Shares. As a
result, prices may vary as between purchasers and during the
period of distribution.
The compensation to MLV for sales of our Common Shares under
this prospectus supplement will be equal to three percent (3%)
of the gross proceeds from the sale of such Common Shares. In
addition, MLV will be reimbursed for reasonable
out-of-pocket
expenses under certain conditions. See Plan of
Distribution. The net proceeds from any sales under this
prospectus supplement will be used as described under the
section titled Use of Proceeds in this prospectus
supplement. The proceeds we receive from sales will depend on
the number of shares actually sold and the offering price of
such shares. Depending on the trading price of our Common Shares
on NASDAQ, we may not be able to sell all 12,500,000 Common
Shares offered hereby or we may not be able to raise the full
$19.8 million in gross proceeds permitted under the Sales
Agreement. The actual proceeds to us will vary. In connection
with the sale of the Common Shares on our behalf, MLV will be
deemed to be an underwriter within the meaning of
the Securities Act, and the compensation of MLV will be deemed
to be underwriting commissions or discounts. We have agreed to
provide indemnification and contribution to MLV against certain
liabilities, including liabilities under the Securities Act.
The Common Shares will be listed on NASDAQ. The TSX
has conditionally approved the listing of the Common Shares
offered for sale pursuant to this prospectus supplement. Listing
is subject to the Company fulfilling all of the requirements of
the TSX on or before the business day immediately following the
date on which this prospectus supplement is filed.
Investing in our Common Shares involves a high degree of
risk. See Risk Factors beginning on
Page S-5
and the risk factors described in the documents incorporated by
reference herein for information that should be considered
before investing in our Common Shares.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus supplement. Any representation to the contrary is a
criminal offense.
The date of this prospectus supplement is February 22, 2011
TABLE OF
CONTENTS
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S-2
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S-3
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S-3
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S-5
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S-19
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S-19
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S-20
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S-20
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S-21
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S-22
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S-22
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S-23
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S-28
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S-28
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S-28
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This prospectus supplement is not an offer to or solicitation
of any person in any jurisdiction in which such offer or
solicitation is illegal.
ABOUT
THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus
supplement, which describes the terms of this offering of our
Common Shares and supplements information contained in the
accompanying prospectus and the documents incorporated by
reference into the accompanying prospectus. The second part is
the accompanying prospectus, which gives more general
information about us and the Common Shares we may offer from
time to time under our shelf registration statement.
We have not authorized any dealer, salesperson or other person
to give any information or to make any representation other than
those contained or incorporated by reference into this
prospectus supplement, the accompanying prospectus and any
related free writing prospectus. You should not rely upon any
information or representation not contained or incorporated by
reference into this prospectus supplement, the accompanying
prospectus or any free writing prospectus that we may authorize
to be provided to you. This prospectus supplement, the
accompanying prospectus and any related free writing prospectus
do not constitute an offer to sell or the solicitation of an
offer to buy Common Shares, in any jurisdiction to any person to
whom it is unlawful to make such offer or solicitation in such
jurisdiction. You should not assume that the information
contained in this prospectus supplement, the accompanying
prospectus and any related free writing prospectus is accurate
on any date other than the date set forth on the front cover of
the document or that any information we have incorporated by
reference is correct on any date subsequent to the date of the
document incorporated by reference regardless of the delivery of
this prospectus supplement, the accompanying prospectus and any
related free writing prospectus or any sale of Common Shares.
Our business, financial condition, results of operations and
prospects may have changed since those dates.
We further note that the representations, warranties and
covenants made by us in any agreement that is filed as an
exhibit to any document that is incorporated by reference into
the accompanying prospectus were made solely for the benefit of
the parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreements,
and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or
covenants were accurate only as of the date when made.
Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
As used in this prospectus supplement, the terms we,
us, our, Company and
Aeterna Zentaris refer to Aeterna Zentaris Inc. and
its subsidiaries on a consolidated basis.
S-2
PROSPECTUS
SUPPLEMENT SUMMARY
This summary highlights selected information contained
elsewhere or incorporated by reference into this prospectus
supplement and the accompanying prospectus. The summary may not
contain all of the information that you should consider before
investing in our Common Shares. You should read the entire
prospectus supplement and the accompanying prospectus carefully,
including Risk Factors contained in this prospectus
supplement and the documents incorporated by reference into the
accompanying prospectus, before making an investment decision.
This prospectus supplement may add to, update or change
information in the accompanying prospectus.
Our
Business and Corporate Information
We are a late-stage drug development company specialized in
oncology and endocrine therapy. Our pipeline encompasses
compounds at all stages of development, from drug discovery
through to marketed products. The highest priorities in oncology
are our Phase 3 program with perifosine in multiple myeloma and
colorectal cancer, combined with our Phase 2 program in multiple
cancers, as well as the further advancement of AEZS-108 which
recently completed with success a Phase 2 trial in advanced
endometrial and advanced ovarian cancer. AEZS-108 is also in
development in other cancer indications, including refractory
bladder and castration refractory prostate cancer. In
endocrinology, our lead program is our Phase 3 trial with
AEZS-130
(Soloreltm)
as a growth hormone (GH) stimulation test for the
diagnosis of GH deficiency in adults. We are advancing this
Phase 3 trial with a Special Protocol Assessment
(SPA) obtained from the Food and Drug Administration
(FDA).
Aeterna Zentaris Inc. was incorporated on September 12,
1990 under the laws of Canada. Our registered office is located
at 1405 du Parc-Technologique Blvd., Quebec City, Quebec, Canada
G1P 4P5, our telephone number is
(418) 652-8525
and our website is www.aezsinc.com. None of the documents or
information found on our website shall be deemed to be included
in or incorporated into this prospectus supplement or the
accompanying prospectus, unless such document is specifically
incorporated herein by reference.
We currently have three wholly-owned direct and indirect
subsidiaries, Aeterna Zentaris GmbH (AEZS Germany),
based in Frankfurt, Germany, Zentaris IVF GmbH, a direct
wholly-owned subsidiary of AEZS Germany, based in Frankfurt,
Germany and Aeterna Zentaris, Inc., based in Warren, New Jersey
in the United States. AEZS Germany is our principal operating
subsidiary.
The
Offering
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Common Shares offered by us pursuant to this prospectus
supplement: |
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Up to a maximum of 12,500,000 Common Shares |
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Manner of offering: |
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At-the-market
offering that may be made from time to time through our agent,
MLV. See Plan of Distribution on
page S-22. |
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Use of proceeds: |
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We intend to use the net proceeds from this offering for working
capital and other general corporate purposes. See Use of
Proceeds on page . |
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NASDAQ Global Market and TSX symbols: |
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NASDAQ: AEZS; TSX: AEZ |
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Risk factors: |
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An investment in our Common Shares involves a high degree of
risk. See Risk Factors beginning on
page S-5
of this prospectus supplement as well as the other information
included in or incorporated by reference into this prospectus
supplement and the accompanying prospectus for a discussion of
factors you should consider carefully before making an
investment decision. |
SPECIAL
NOTE ON FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the
documents incorporated by reference contain forward-looking
statements. These forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. In some
cases, you can identify forward-looking statements by terms such
as may, will, should,
could, would, expect,
plan, intend, anticipate,
believe, estimate, project,
predict, forecast,
potential, likely or
possible, as well as the negative of such
expressions, and similar expressions intended to identify
forward-looking statements. Some of the
S-3
factors that we believe could affect our actual results to
differ, and these forward-looking statements include, without
limitation, statements relating to:
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investments in biopharmaceutical companies are generally
considered to be speculative;
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we may never achieve or maintain operating profitability;
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our clinical trials may not yield results which will enable us
to obtain regulatory approval for our products and we may suffer
setbacks in any of our clinical trials;
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we may not be able to successfully complete our clinical trial
programs, or such clinical trials could take longer to complete
than we project;
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the impact of the stringent ongoing government regulation to
which our product candidates are subject and future changes in
such regulatory environment;
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we may not be able to generate significant revenues if our
products do not gain market acceptance;
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we may require significant additional financing, and we may not
have access to sufficient capital;
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we may cease to continue operating as we do if we are
unsuccessful in increasing our revenues and/or raising
additional funding;
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failure to achieve our projected development goals in the
time-frames we announce and expect;
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the impact of any failure on our part to obtain acceptable
prices or adequate reimbursement for our products on our ability
to generate revenues;
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competition in our targeted markets;
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we may not obtain adequate protection for our products through
our intellectual property;
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we may infringe the intellectual property rights of others;
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we may incur liabilities from our involvement in any patent
litigation;
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we may not obtain trademark registrations in connection with our
product candidates;
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we may not be able to make adequate arrangements with third
parties for the purpose of commercializing our product
candidates;
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the failure to perform satisfactorily by third parties upon
which we rely to conduct, supervise and monitor our clinical
trials;
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the failure to perform satisfactorily by third parties upon
which we rely to manufacture and supply products;
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our ability to retain or attract key personnel;
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our strategic partners manufacturing capabilities may not
be adequate to effectively commercialize our product candidates;
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risks related to product liability claims;
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the impact of legislative actions, new accounting pronouncements
and higher insurance costs on our future financial position or
results of operations;
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fluctuations in currency exchange rates; and
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stock market volatility and the possibility that our Common
Shares may be delisted from the stock exchanges on which they
currently trade.
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There may be events in the future that we are unable to predict
accurately, or over which we have no control. Before you
purchase our Common Shares, you should read this prospectus
supplement, the accompanying prospectus and the documents that
we reference or incorporate by reference into this prospectus
supplement and the accompanying prospectus, completely and with
the understanding that our actual future results may be
materially different from what we expect. Our business,
financial condition, results of operations, and prospects may
change. We may not update these forward-looking statements, even
though our situation may change in the future, unless we have
obligations under the federal securities laws to update and
disclose material developments related to previously disclosed
information. We qualify all of the information presented or
incorporated by reference in this prospectus supplement and the
accompanying prospectus, and particularly our forward-looking
statements, by these cautionary statements.
S-4
RISK
FACTORS
Before making an investment decision, you should carefully
consider the risks described in this prospectus supplement,
together with all of the other information incorporated by
reference into this prospectus supplement and the accompanying
prospectus, including those described in our most recent Annual
Report on
Form 20-F
and subsequent Reports on
Form 6-K
furnished to the Securities and Exchange Commission (the
SEC) including our unaudited interim financial
statements and corresponding managements discussion and
analysis. The following risks are presented as of the date of
this prospectus supplement and we expect that these will be
updated from time to time in our periodic and current reports
filed with or furnished to the SEC, as applicable, which will be
incorporated herein by reference. Please refer to these
subsequent reports for additional information relating to the
risks associated with investing in our Common Shares.
Our business, financial condition or results of operations
could be materially adversely affected by any of these risks.
Additional risks not presently known to us or that we currently
deem immaterial may also impair our business operations. The
trading price of our Common Shares could decline due to any of
these risks, and you may lose part or all of your investment.
This prospectus supplement, the accompanying prospectus and the
incorporated documents also contain forward-looking statements
that involve risks and uncertainties. Our actual results could
differ materially from those anticipated in these
forward-looking statements as a result of certain factors,
including the risks mentioned below. Forward-looking statements
included in this prospectus supplement are based on information
available to us on the date hereof, and all forward-looking
statements in documents incorporated by reference are based on
information available to us as of the date of such documents. We
disclaim any intent to update any forward-looking statements.
Risks
Relating to Us and Our Business
Investments
in biopharmaceutical companies are generally considered to be
speculative.
The prospects for companies operating in the biopharmaceutical
industry may generally be considered to be uncertain, given the
very nature of the industry and, accordingly, investments in
biopharmaceutical companies should be considered to be
speculative.
We
have a history of operating losses and we may never achieve or
maintain operating profitability.
Our product candidates remain at the development stage, and we
have incurred substantial expenses in our efforts to develop
products. Consequently, we have incurred recurrent operating
losses and, as disclosed in our unaudited interim consolidated
financial statements as at September 30, 2010 and for the
three- and nine-month periods ended September 30, 2010 and
2009, we had an accumulated deficit of $148.0 million as at
September 30, 2010. Our operating losses have adversely
impacted, and will continue to adversely impact, our working
capital, total assets and shareholders equity. We do not
expect to reach operating profitability in the immediate future,
and our expenses are likely to increase as we continue to expand
our research and development (R&D) and clinical
study programs and our sales and marketing activities and seek
regulatory approval for our product candidates. Even if we
succeed in developing new commercial products, we expect to
incur additional operating losses for at least the next several
years. If we do not ultimately generate sufficient revenue from
commercialized products and achieve or maintain operating
profitability, an investment in our securities could result in a
significant or total loss.
Our
clinical trials may not yield results which will enable us to
obtain regulatory approval for our products, and a setback in
any of our clinical trials would likely cause a drop in the
price of our securities.
We will only receive regulatory approval for a product candidate
if we can demonstrate in carefully designed and conducted
clinical trials that the product candidate is both safe and
effective. We do not know whether our pending or any future
clinical trials will demonstrate sufficient safety and efficacy
to obtain the requisite regulatory approvals or will result in
marketable products. Unfavorable data from those studies could
result in the withdrawal of marketing approval for approved
products or an extension of the review period for developmental
products. Clinical trials are inherently lengthy, complex,
expensive and uncertain processes and have a high risk of
failure. It typically takes many years to complete testing, and
failure can occur at any stage of testing. Results attained in
pre-clinical testing and early clinical studies, or trials, may
not be indicative of results that are obtained in later studies.
None of our product candidates has to date received regulatory
approval for its intended commercial sale. We cannot market a
pharmaceutical product in any jurisdiction until it has
completed rigorous pre-clinical testing and clinical trials and
passed such jurisdictions extensive regulatory approval
process. In general, significant research and development and
clinical studies are required to demonstrate the safety and
efficacy of our product candidates before we can submit
S-5
regulatory applications. Pre-clinical testing and clinical
development are long, expensive and uncertain processes.
Preparing, submitting and advancing applications for regulatory
approval is complex, expensive and time-consuming and entails
significant uncertainty. Data obtained from pre-clinical and
clinical tests can be interpreted in different ways, which could
delay, limit or prevent regulatory approval. It may take us many
years to complete the testing of our product candidates and
failure can occur at any stage of this process. In addition, we
have limited experience in conducting and managing the clinical
trials necessary to obtain regulatory approval in the United
States, in Canada and abroad and, accordingly, may encounter
unforeseen problems and delays in the approval process. Though
we may engage a clinical research organization with experience
in conducting regulatory trials, errors in the conduct,
monitoring and/or auditing could invalidate the results from a
regulatory perspective. Even if a product candidate is approved
by the FDA, the Canadian Therapeutic Products Directorate or any
other regulatory authority, we may not obtain approval for an
indication whose market is large enough to recoup our investment
in that product candidate. In addition, there can be no
assurance that we will ever obtain all or any required
regulatory approvals for any of our product candidates.
We are currently developing our product candidates based on
R&D activities, pre-clinical testing and clinical trials
conducted to date, and we may not be successful in developing or
introducing to the market these or any other new products or
technology. If we fail to develop and deploy new products
successfully and on a timely basis, we may become
non-competitive and unable to recoup the R&D and other
expenses we incur to develop and test new products.
Interim results of pre-clinical or clinical studies do not
necessarily predict their final results, and acceptable results
in early studies might not be obtained in later studies. Safety
signals detected during clinical studies and pre-clinical animal
studies may require us to do additional studies, which could
delay the development of the drug or lead to a decision to
discontinue development of the drug. Product candidates in the
later stages of clinical development may fail to show the
desired safety and efficacy traits despite positive results in
initial clinical testing. Results from earlier studies may not
be indicative of results from future clinical trials and the
risk remains that a pivotal program may generate efficacy data
that will be insufficient for the approval of the drug, or may
raise safety concerns that may prevent approval of the drug.
Interpretation of the prior pre-clinical and clinical safety and
efficacy data of our product candidates may be flawed and there
can be no assurance that safety and/or efficacy concerns from
the prior data were overlooked or misinterpreted, which in
subsequent, larger studies appear and prevent approval of such
product candidates.
Furthermore, we may suffer significant setbacks in advanced
clinical trials, even after promising results in earlier
studies. Based on results at any stage of clinical trials, we
may decide to repeat or redesign a trial or discontinue
development of one or more of our product candidates. Further,
actual results may vary once the final and quality-controlled
verification of data and analyses has been completed. If we fail
to adequately demonstrate the safety and efficacy of our
products under development, we will not be able to obtain the
required regulatory approvals to commercialize our product
candidates.
Clinical trials are subject to continuing oversight by
governmental regulatory authorities and institutional review
boards and:
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must meet the requirements of these authorities;
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must meet requirements for informed consent; and
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must meet requirements for good clinical practices.
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We may not be able to comply with these requirements in respect
of one or more of our product candidates.
In addition, we rely on third parties, including Contract
Research Organizations (CROs) and outside
consultants, to assist us in managing and monitoring clinical
trials. Our reliance on these third parties may result in delays
in completing, or in failing to complete, these trials if one or
more third parties fails to perform with the speed and level of
competence we expect.
A failure in the development of any one of our programs or
product candidates could have a negative impact on the
development of the others. Setbacks in any phase of the clinical
development of our product candidates would have an adverse
financial impact (including with respect to any agreements and
partnerships that may exist between us and other entities),
could jeopardize regulatory approval and would likely cause a
drop in the price of our securities.
If we
are unable to successfully complete our clinical trial programs,
or if such clinical trials take longer to complete than we
project, our ability to execute our current business strategy
will be adversely affected.
Whether or not and how quickly we complete clinical trials is
dependent in part upon the rate at which we are able to engage
clinical trial sites and, thereafter, the rate of enrollment of
patients, and the rate we collect, clean, lock and analyze
S-6
the clinical trial database. Patient enrollment is a function of
many factors, including the design of the protocol, the size of
the patient population, the proximity of patients to and
availability of clinical sites, the eligibility criteria for the
study, the perceived risks and benefits of the drug under study
and of the control drug, if any, the efforts to facilitate
timely enrollment in clinical trials, the patient referral
practices of physicians, the existence of competitive clinical
trials, and whether existing or new drugs are approved for the
indication we are studying. Certain clinical trials are designed
to continue until a pre-determined number of events have
occurred to the patients enrolled. Trials such as this are
subject to delays stemming from patient withdrawal and from
lower than expected event rates and may also incur increased
costs if enrollment is increased in order to achieve the desired
number of events. If we experience delays in identifying and
contracting with sites and/or in patient enrollment in our
clinical trial programs, we may incur additional costs and
delays in our development programs, and may not be able to
complete our clinical trials on a cost-effective or timely
basis. In addition, conducting multi-national studies adds
another level of complexity and risk as we are subject to events
affecting countries outside Canada. Moreover, negative or
inconclusive results from the clinical trials we conduct or
adverse medical events could cause us to have to repeat or
terminate the clinical trials. Accordingly, we may not be able
to complete the clinical trials within an acceptable time frame,
if at all. If we or any third party have difficulty enrolling a
sufficient number of patients to conduct our clinical trials as
planned, we may need to delay or terminate ongoing clinical
trials.
Additionally, we have never filed a new drug application
(NDA), or similar application for approval in the
United States or in any country for our current product
candidates, which may result in a delay in, or the rejection of,
our filing of an NDA or similar application. During the drug
development process, regulatory agencies will typically ask
questions of drug sponsors. While we endeavor to answer all such
questions in a timely fashion, or in the NDA filing, some
questions may not be answered by the time we file our NDA.
Unless the FDA waives the requirement to answer any such
unanswered questions, submission of an NDA may be delayed or
rejected.
We are
and will be subject to stringent ongoing government regulation
for our products and our product candidates, even if we obtain
regulatory approvals for the latter.
The manufacture, marketing and sale of our products and product
candidates are and will be subject to strict and ongoing
regulation, even if regulatory authorities approve any of the
latter. Compliance with such regulation will be expensive and
consume substantial financial and management resources. For
example, an approval for a product may be conditioned on our
agreement to conduct costly post-marketing
follow-up
studies to monitor the safety or efficacy of the products. In
addition, as a clinical experience with a drug expands after
approval because the drug is used by a greater number and more
diverse group of patients than during clinical trials, side
effects or other problems may be observed after approval that
were not observed or anticipated during pre-approval clinical
trials. In such a case, a regulatory authority could restrict
the indications for which the product may be sold or revoke the
products regulatory approval.
We and our contract manufacturers are and will be required to
comply with applicable current Good Manufacturing Practice
(cGMP) regulations for the manufacture of our
products. These regulations include requirements relating to
quality assurance, as well as the corresponding maintenance of
rigorous records and documentation. Manufacturing facilities
must be approved before we can use them in the commercial
manufacturing of our products and are subject to subsequent
periodic inspection by regulatory authorities. In addition,
material changes in the methods of manufacturing or changes in
the suppliers of raw materials are subject to further regulatory
review and approval.
If we, or any future marketing collaborators or contract
manufacturers, fail to comply with applicable regulatory
requirements, we may be subject to sanctions including fines,
product recalls or seizures and related publicity requirements,
injunctions, total or partial suspension of production, civil
penalties, suspension or withdrawals of previously granted
regulatory approvals, warning or untitled letters, refusal to
approve pending applications for marketing approval of new
products or of supplements to approved applications, import or
export bans or restrictions, and criminal prosecution and
penalties. Any of these penalties could delay or prevent the
promotion, marketing or sale of our products and product
candidates.
If our
products do not gain market acceptance, we may be unable to
generate significant revenues.
Even if our products are approved for commercialization, they
may not be successful in the marketplace. Market acceptance of
any of our products will depend on a number of factors
including, but not limited to:
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demonstration of clinical efficacy and safety;
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the prevalence and severity of any adverse side effects;
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limitations or warnings contained in the products approved
labeling;
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availability of alternative treatments for the indications we
target;
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the advantages and disadvantages of our products relative to
current or alternative treatments;
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the availability of acceptable pricing and adequate third-party
reimbursement; and
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the effectiveness of marketing and distribution methods for the
products.
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If our products do not gain market acceptance among physicians,
patients, healthcare payers and others in the medical community,
which may not accept or utilize our products, our ability to
generate significant revenues from our products would be limited
and our financial conditions will be materially adversely
affected. In addition, if we fail to further penetrate our core
markets and existing geographic markets or successfully expand
our business into new markets, the growth in sales of our
products, along with our operating results, could be negatively
impacted.
Our ability to further penetrate our core markets and existing
geographic markets in which we compete or to successfully expand
our business into additional countries in Europe, Asia or
elsewhere is subject to numerous factors, many of which are
beyond our control. Our products, if successfully developed, may
compete with a number of drugs and therapies currently
manufactured and marketed by major pharmaceutical and other
biotechnology companies. Our products may also compete with new
products currently under development by others or with products
which may be less expensive than our products. We cannot assure
you that our efforts to increase market penetration in our core
markets and existing geographic markets will be successful. Our
failure to do so could have an adverse effect on our operating
results and would likely cause a drop in the price of our
securities.
We may
require significant additional financing, and we may not have
access to sufficient capital.
We may require additional capital to pursue planned clinical
trials, regulatory approvals, as well as further R&D and
marketing efforts for our product candidates and potential
products. Except as expressly described in this prospectus
supplement and the accompanying prospectus and the documents
incorporated by reference herein and therein, we do not
anticipate generating significant revenues from operations in
the near future and we currently have no committed sources of
capital.
We may attempt to raise additional funds through public or
private financings, collaborations with other pharmaceutical
companies or financing from other sources. Additional funding
may not be available on terms which are acceptable to us. If
adequate funding is not available to us on reasonable terms, we
may need to delay, reduce or eliminate one or more of our
product development programs or obtain funds on terms less
favorable than we would otherwise accept. To the extent that
additional capital is raised through the sale of equity
securities or securities convertible into or exchangeable for
equity securities, the issuance of those securities could result
in dilution to our shareholders. Moreover, the incurrence of
debt financing could result in a substantial portion of our
future operating cash flow, if any, being dedicated to the
payment of principal and interest on such indebtedness and could
impose restrictions on our operations. This could render us more
vulnerable to competitive pressures and economic downturns.
We anticipate that our existing working capital, including the
proceeds from any sale of securities hereunder and anticipated
revenues, will be sufficient to fund our development programs,
clinical trials and other operating expenses for the near
future. However, our future capital requirements are substantial
and may increase beyond our current expectations depending on
many factors including:
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the duration and results of our clinical trials for our various
product candidates going forward;
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unexpected delays or developments in seeking regulatory
approvals;
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the time and cost involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims;
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other unexpected developments encountered in implementing our
business development and commercialization strategies;
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the outcome of litigation, if any; and
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further arrangements, if any, with collaborators.
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In addition, the ongoing recessionary global market and economic
conditions as well as certain continuing difficulties in the
credit and capital markets may make it even more difficult for
us to raise additional financing in the future.
S-8
A
substantial portion of our future revenues may be dependent upon
our agreement with Keryx Biopharmaceuticals, Inc.
We currently expect that a substantial portion of our future
revenues may be dependent upon our strategic partnership with
Keryx Biopharmaceuticals, Inc. (Keryx). Under this
strategic partnership, Keryx has significant development and
commercialization responsibilities with respect to the
development and sale of Perifosine. If Keryx were to terminate
its agreement with us, fail to meet its obligations or otherwise
decrease its level of efforts, allocation of resources or other
commitments under this agreement, our future revenues and/or
prospects could be negatively impacted and the development and
commercialization of Perifosine would be interrupted. In
addition, if Keryx does not achieve some or any of the
development, regulatory and commercial milestones or if it does
not achieve certain net sales thresholds as set forth in the
agreement, we will not fully realize the expected economic
benefits of the agreement. Further, the achievement of certain
of the milestones under this strategic partnership agreement
will depend on factors that are outside of our control and most
are not expected to be achieved for several years, if at all.
Any failure to successfully maintain our strategic partnership
agreement could materially and adversely affect our ability to
generate revenues.
If we
are unsuccessful in increasing our revenues and/or raising
additional funding, we may possibly cease to continue operating
as we currently do.
Although our unaudited interim consolidated financial statements
as at September 30, 2010 and for the three- and nine-month
periods ended September 30, 2010 and 2009 have been
prepared on a going concern basis, which contemplates the
realization of assets and liquidation of liabilities during the
normal course of operations, our ability to continue as a going
concern is dependent on the successful execution of our business
plan, which will require an increase in revenue and/or
additional funding to be provided by potential investors as well
as non-traditional sources of financing. Although we stated in
our unaudited interim consolidated financial statements as at
September 30, 2010 and for the three- and nine-month
periods ended September 30, 2010 and 2009 that management
believed that the Company had, as at September 30, 2010,
sufficient financial resources to fund planned expenditures and
other working capital needs for at least, but not limited to,
the 12-month
period following such date, there can be no assurance that
management will be able to reiterate such belief in our future
financial statements.
We have had sustained losses, accumulated deficits and negative
cash flows from operations since our inception. We expect that
this will continue throughout 2011.
Additional funding may be in the form of debt or equity or a
hybrid instrument depending on the needs of the investor. Given
the prevailing global economic and credit market conditions, we
may not be able to raise additional cash resources through these
traditional sources of financing. Although we are also pursuing
non-traditional sources of financing, the global credit market
crisis has also adversely affected the ability of potential
parties to pursue such transactions. We do not believe that the
ability to access capital markets or these adverse conditions
are likely to improve significantly in the near future.
Accordingly, as a result of the foregoing, we continue to review
traditional sources of financing, such as private and public
debt or various equity financing alternatives, as well as other
alternatives to enhance shareholder value including, but not
limited to, non-traditional sources of financing, such as
alliances with strategic partners, the sale of assets or
licensing of our technology or intellectual property, a
combination of operating and related initiatives or a
substantial reorganization of our business. If we do not raise
additional capital, we do not expect our operations to generate
sufficient cash flow to fund our obligations as they come due.
There can be no assurances that we will achieve profitability or
positive cash flows or be able to obtain additional funding or
that, if obtained, they will be sufficient, or whether any other
initiatives will be successful, such that we may continue as a
going concern. There are material uncertainties related to
certain adverse conditions and events that could cast
significant doubt on our ability to remain a going concern.
We may
not achieve our projected development goals in the time-frames
we announce and expect.
We set goals and make public statements regarding the timing of
the accomplishment of objectives material to our success, such
as the commencement, enrollment and completion of clinical
trials, anticipated regulatory submission and approval dates and
time of product launch. The actual timing of these events can
vary dramatically due to factors such as delays or failures in
our clinical trials, the uncertainties inherent in the
regulatory approval process and delays in achieving
manufacturing or marketing arrangements sufficient to
commercialize our products. There can be no assurance that our
clinical trials will be completed, that we will make regulatory
submissions or receive regulatory approvals as planned or that
we will be able to adhere to our current schedule for the launch
of any of our products. If we fail to achieve one or more of
these milestones as planned, the price of our securities would
likely decline.
S-9
If we
fail to obtain acceptable prices or adequate reimbursement for
our products, our ability to generate revenues will be
diminished.
The ability for us and/or our partners to successfully
commercialize our products will depend significantly on our
ability to obtain acceptable prices and the availability of
reimbursement to the patient from third-party payers, such as
governmental and private insurance plans. These third-party
payers frequently require companies to provide predetermined
discounts from list prices, and they are increasingly
challenging the prices charged for pharmaceuticals and other
medical products. Our products may not be considered
cost-effective, and reimbursement to the patient may not be
available or sufficient to allow us or our partners to sell our
products on a competitive basis. It may not be possible to
negotiate favorable reimbursement rates for our products.
In addition, the continuing efforts of third-party payers to
contain or reduce the costs of healthcare through various means
may limit our commercial opportunity and reduce any associated
revenue and profits. We expect proposals to implement similar
government control to continue. In addition, increasing emphasis
on managed care will continue to put pressure on the pricing of
pharmaceutical and biopharmaceutical products. Cost control
initiatives could decrease the price that we or any current or
potential collaborators could receive for any of our products
and could adversely affect our profitability. In addition, in
the United States, in Canada and in many other countries,
pricing and/or profitability of some or all prescription
pharmaceuticals and biopharmaceuticals are subject to government
control.
If we fail to obtain acceptable prices or an adequate level of
reimbursement for our products, the sales of our products would
be adversely affected or there may be no commercially viable
market for our products.
Competition
in our targeted markets is intense, and development by other
companies could render our products or technologies
non-competitive.
The biomedical field is highly competitive. New products
developed by other companies in the industry could render our
products or technologies non-competitive. Competitors are
developing and testing products and technologies that would
compete with the products that we are developing. Some of these
products may be more effective or have an entirely different
approach or means of accomplishing the desired effect than our
products. We expect competition from biopharmaceutical and
pharmaceutical companies and academic research institutions to
increase over time. Many of our competitors and potential
competitors have substantially greater product development
capabilities and financial, scientific, marketing and human
resources than we do. Our competitors may succeed in developing
products earlier and in obtaining regulatory approvals and
patent protection for such products more rapidly than we can or
at a lower price.
We may
not obtain adequate protection for our products through our
intellectual property.
We rely heavily on our proprietary information in developing and
manufacturing our product candidates. Our success depends, in
large part, on our ability to protect our competitive position
through patents, trade secrets, trademarks and other
intellectual property rights. The patent positions of
pharmaceutical and biopharmaceutical firms, including Aeterna
Zentaris, are uncertain and involve complex questions of law and
fact for which important legal issues remain unresolved.
Applications for patents and trademarks in Canada, the United
States and in other foreign territories have been filed and are
being actively pursued by us. Pending patent applications may
not result in the issuance of patents and we may not be able to
obtain additional issued patents relating to our technology or
products. Even if issued, patents to us or our licensors may be
challenged, narrowed, invalidated, held to be unenforceable or
circumvented, which could limit our ability to stop competitors
from marketing similar products or limit the length of term of
patent protection we may have for our products. Changes in
either patent laws or in interpretations of patent laws in the
United States and other countries may diminish the value of our
intellectual property or narrow the scope of our patent
protection. The patents issued or to be issued to us may not
provide us with any competitive advantage or protect us against
competitors with similar technology. In addition, it is possible
that third parties with products that are very similar to ours
will circumvent our patents by means of alternate designs or
processes. We may have to rely on method of use and new
formulation protection for our compounds in development, and any
resulting products, which may not confer the same protection as
claims to compounds per se.
In addition, our patents may be challenged by third parties in
patent litigation, which is becoming widespread in the
biopharmaceutical industry. There may be prior art of which we
are not aware that may affect the validity or enforceability of
a patent claim. There also may be prior art of which we are
aware, but which we do not believe affects the validity or
enforceability of a claim, which may, nonetheless, ultimately be
found to affect the validity or enforceability of a claim. No
assurance can be given that our patents would, if challenged, be
held by a court to be valid or enforceable or that a
competitors technology or product would be found by a
court to infringe our patents. Our granted patents could also be
S-10
challenged and revoked in opposition or nullity proceedings in
certain countries outside the United States. In addition, we may
be required to disclaim part of the term of certain patents.
Patent applications relating to or affecting our business have
been filed by a number of pharmaceutical and biopharmaceutical
companies and academic institutions. A number of the
technologies in these applications or patents may conflict with
our technologies, patents or patent applications, and any such
conflict could reduce the scope of patent protection which we
could otherwise obtain. Because patent applications in the
United States and many other jurisdictions are typically not
published until eighteen months after their first effective
filing date, or in some cases not at all, and because
publications of discoveries in the scientific literature often
lag behind actual discoveries, neither we nor our licensors can
be certain that we or they were the first to make the inventions
claimed in our or their issued patents or pending patent
applications, or that we or they were the first to file for
protection of the inventions set forth in these patent
applications. If a third party has also filed a patent
application in the United States covering our product candidates
or a similar invention, we may have to participate in an
adversarial proceeding, known as an interference, declared by
the United States Patent and Trademark Office to determine
priority of invention in the United States. The costs of these
proceedings could be substantial and it is possible that our
efforts could be unsuccessful, resulting in a loss of our U.S.
patent position.
In addition to patents, we rely on trade secrets and proprietary
know-how to protect our intellectual property. If we are unable
to protect the confidentiality of our proprietary information
and know-how, the value of our technology and products could be
adversely affected. We seek to protect our unpatented
proprietary information in part by requiring our employees,
consultants, outside scientific collaborators and sponsored
researchers and other advisors to enter into confidentiality
agreements. These agreements provide that all confidential
information developed or made known to the individual during the
course of the individuals relationship with us is to be
kept confidential and not disclosed to third parties except in
specific circumstances. In the case of our employees, the
agreements provide that all of the technology which is conceived
by the individual during the course of employment is our
exclusive property. These agreements may not provide meaningful
protection or adequate remedies in the event of unauthorized use
or disclosure of our proprietary information. In addition, it is
possible that third parties could independently develop
proprietary information and techniques substantially similar to
ours or otherwise gain access to our trade secrets. If we are
unable to protect the confidentiality of our proprietary
information and know-how, competitors may be able to use this
information to develop products that compete with our products
and technologies, which could adversely impact our business.
We currently have the right to use certain technology under
license agreements with third parties. Our failure to comply
with the requirements of material license agreements could
result in the termination of such agreements, which could cause
us to terminate the related development program and cause a
complete loss of our investment in that program.
As a result of the foregoing factors, we may not be able to rely
on our intellectual property to protect our products in the
marketplace.
We may
infringe the intellectual property rights of
others.
Our commercial success depends significantly on our ability to
operate without infringing the patents and other intellectual
property rights of third parties. There could be issued patents
of which we are not aware that our products or methods may be
found to infringe, or patents of which we are aware and believe
we do not infringe but which we may ultimately be found to
infringe. Moreover, patent applications and their underlying
discoveries are in some cases maintained in secrecy until
patents are issued. Because patents can take many years to
issue, there may be currently pending applications of which we
are unaware that may later result in issued patents that our
products or methods are found to infringe. Moreover, there may
be published pending applications that do not currently include
a claim covering our products or methods but which nonetheless
provide support for a later drafted claim that, if issued, our
products or methods could be found to infringe.
If we infringe or are alleged to infringe intellectual property
rights of third parties, it will adversely affect our business.
Our research, development and commercialization activities, as
well as any product candidates or products resulting from these
activities, may infringe or be accused of infringing one or more
claims of an issued patent or may fall within the scope of one
or more claims in a published patent application that may
subsequently issue and to which we do not hold a license or
other rights. Third parties may own or control these patents or
patent applications in the United States and abroad. These third
parties could bring claims against us or our collaborators that
would cause us to incur substantial expenses and, if successful
against us, could cause us to pay substantial damages. Further,
if a patent infringement suit
S-11
were brought against us or our collaborators, we or they could
be forced to stop or delay research, development, manufacturing
or sales of the product or product candidate that is the subject
of the suit.
The biopharmaceutical industry has produced a proliferation of
patents, and it is not always clear to industry participants,
including us, which patents cover various types of products. The
coverage of patents is subject to interpretation by the courts,
and the interpretation is not always uniform. In the event of
infringement or violation of another partys patent or
other intellectual property rights, we may not be able to enter
into licensing arrangements or make other arrangements at a
reasonable cost. Any inability to secure licenses or alternative
technology could result in delays in the introduction of our
products or lead to prohibition of the manufacture or sale of
products by us or our partners and collaborators.
Patent
litigation is costly and time consuming and may subject us to
liabilities.
Our involvement in any patent litigation, interference,
opposition or other administrative proceedings will likely cause
us to incur substantial expenses, and the efforts of our
technical and management personnel will be significantly
diverted. In addition, an adverse determination in litigation
could subject us to significant liabilities.
We may
not obtain trademark registrations.
We have filed applications for trademark registrations in
connection with our product candidates in various jurisdictions,
including the United States. We intend to file further
applications for other possible trademarks for our product
candidates. No assurance can be given that any of our trademark
applications will be registered in the United States or
elsewhere, or that the use of any registered or unregistered
trademarks will confer a competitive advantage in the
marketplace. Furthermore, even if we are successful in our
trademark registrations, the FDA and regulatory authorities in
other countries have their own process for drug nomenclature and
their own views concerning appropriate proprietary names. The
FDA and other regulatory authorities also have the power, even
after granting market approval, to request a company to
reconsider the name for a product because of evidence of
confusion in the marketplace. No assurance can be given that the
FDA or any other regulatory authority will approve of any of our
trademarks or will not request reconsideration of one of our
trademarks at some time in the future. The loss, abandonment, or
cancellation of any of our trademarks or trademark applications
could negatively affect the success of the product candidates to
which they relate.
Our
revenues and expenses may fluctuate significantly, and any
failure to meet financial expectations may disappoint securities
analysts or investors and result in a decline in the price of
our securities.
We have a history of operating losses. Our revenues and expenses
have fluctuated in the past and are likely to do so in the
future. These fluctuations could cause our share price to
decline. Some of the factors that could cause our revenues and
expenses to fluctuate include but are not limited to:
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the inability to complete product development in a timely manner
that results in a failure or delay in receiving the required
regulatory approvals to commercialize our product candidates;
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the timing of regulatory submissions and approvals;
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the timing and willingness of any current or future
collaborators to invest the resources necessary to commercialize
our product candidates;
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the revenue available from royalties derived from our strategic
partners;
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licensing fees revenues;
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tax credits and grants (R&D);
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the outcome of litigation, if any;
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changes in foreign currency fluctuations;
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the timing of achievement and the receipt of milestone payments
from current or future collaborators; and
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failure to enter into new or the expiration or termination of
current agreements with collaborators.
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Due to fluctuations in our revenues and expenses, we believe
that
period-to-period
comparisons of our results of operations are not necessarily
indicative of our future performance. It is possible that in
some future quarter or quarters, our revenues and expenses will
be above or below the expectations of securities analysts or
investors. In this case, the price of our securities could
fluctuate significantly or decline.
S-12
We
will not be able to successfully commercialize our product
candidates if we are unable to make adequate arrangements with
third parties for such purposes.
We currently have a lean sales and marketing staff. In order to
commercialize our product candidates successfully, we need to
make arrangements with third parties to perform some or all of
these services in certain territories.
We contract with third parties for the sales and marketing of
our products. Our revenues will depend upon the efforts of these
third parties, whose efforts may not be successful. If we fail
to establish successful marketing and sales capabilities or to
make arrangements with third parties for such purposes, our
business, financial condition and results of operations will be
materially adversely affected.
If we had to resort to developing a sales force internally, the
cost of establishing and maintaining a sales force would be
substantial and may exceed its cost effectiveness. In addition,
in marketing our products, we would likely compete with many
companies that currently have extensive and well-funded
marketing and sales operations. Despite our marketing and sales
efforts, we may be unable to compete successfully against these
companies.
We are currently dependent on strategic partners and may enter
into future collaborations for the research, development and
commercialization of our product candidates. Our arrangements
with these strategic partners may not provide us with the
benefits we expect and may expose us to a number of risks.
We are dependent on, and rely upon, strategic partners to
perform various functions related to our business, including,
but not limited to, the research, development and
commercialization of some of our product candidates. Our
reliance on these relationships poses a number of risks.
We may not realize the contemplated benefits of such agreements
nor can we be certain that any of these parties will fulfill
their obligations in a manner which maximizes our revenue. These
arrangements may also require us to transfer certain material
rights or issue our equity, voting or other securities to
corporate partners, licensees and others. Any license or
sublicense of our commercial rights may reduce our product
revenue.
These agreements also create certain risks. The occurrence of
any of the following or other events may delay product
development or impair commercialization of our products:
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not all of our strategic partners are contractually prohibited
from developing or commercializing, either alone or with others,
products and services that are similar to or competitive with
our product candidates and, with respect to our strategic
partnership agreements that do contain such contractual
prohibitions or restrictions, prohibitions or restrictions do
not always apply to our partners affiliates and they may
elect to pursue the development of any additional product
candidates and pursue technologies or products either on their
own or in collaboration with other parties, including our
competitors, whose technologies or products may be competitive
with ours;
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our strategic partners may under-fund or fail to commit
sufficient resources to marketing, distribution or other
development of our products;
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we may not be able to renew such agreements;
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our strategic partners may not properly maintain or defend
certain intellectual property rights that may be important to
the commercialization of our products;
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our strategic partners may encounter conflicts of interest,
changes in business strategy or other issues which could
adversely affect their willingness or ability to fulfill their
obligations to us (for example, pharmaceutical companies
historically have re-evaluated their priorities following
mergers and consolidations, which have been common in recent
years in this industry);
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delays in, or failures to achieve,
scale-up to
commercial quantities, or changes to current raw material
suppliers or product manufacturers (whether the change is
attributable to us or the supplier or manufacturer) could delay
clinical studies, regulatory submissions and commercialization
of our product candidates; and
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disputes may arise between us and our strategic partners that
could result in the delay or termination of the development or
commercialization of our product candidates, resulting in
litigation or arbitration that could be time-consuming and
expensive, or causing our strategic partners to act in their own
self-interest and not in our interest or those of our
shareholders or other stakeholders.
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In addition, our strategic partners can terminate our agreements
with them for a number of reasons based on the terms of the
individual agreements that we have entered into with them. If
one or more of these agreements were to be terminated, we would
be required to devote additional resources to developing and
commercializing our product
S-13
candidates, seek a new partner or abandon this product candidate
which would likely cause a drop in the price of our securities.
We have entered into important strategic partnership agreements
relating to certain of our product candidates for various
indications. Detailed information on our research and
collaboration agreements is available in our various reports and
disclosure documents filed with the Canadian securities
regulatory authorities and filed with or furnished to the SEC,
including the documents incorporated by reference into this
prospectus supplement and the accompanying prospectus. See, for
example, Note 26 to our audited consolidated balance sheets
as at December 31, 2009 and 2008 and our audited
consolidated statements of operations, changes in
shareholders equity, accumulated other comprehensive
income and deficit, comprehensive loss and cash flows for each
of the years in the three-year period ended December 31,
2009 included in our Annual Report on
Form 20-F,
which is incorporated by reference into this prospectus
supplement and the accompanying prospectus.
We have also entered into a variety of collaborative licensing
agreements with various universities and institutes under which
we are obligated to support some of the research expenses
incurred by the university laboratories and pay royalties on
future sales of the products. In turn, we have retained
exclusive rights for the worldwide exploitation of results
generated during the collaborations.
In particular, we have entered into an agreement with the Tulane
Educational Fund (Tulane), which provides for the
payment by us of single-digit royalties on future worldwide net
sales of cetrorelix and including
Cetrotide®.
Tulane is also entitled to receive a low double-digit
participation payment on any lump-sum, periodic or other cash
payments received by us from
sub-licensees
(see Note 26 to our audited consolidated balance sheets as
at December 31, 2009 and 2008 and our audited consolidated
statements of operations, changes in shareholders equity,
accumulated other comprehensive income and deficit,
comprehensive loss and cash flows for each of the years in the
three-year period ended December 31, 2009 included in our
Annual Report on
Form 20-F,
which is incorporated by reference into this prospectus
supplement and the accompanying prospectus).
We
rely on third parties to conduct, supervise and monitor our
clinical trials, and those third parties may not perform
satisfactorily.
We rely on third parties such as CROs, medical institutions and
clinical investigators to enroll qualified patients and conduct,
supervise and monitor our clinical trials. Our reliance on these
third parties for clinical development activities reduces our
control over these activities. Our reliance on these third
parties, however, does not relieve us of our regulatory
responsibilities, including ensuring that our clinical trials
are conducted in accordance with Good Clinical Practice
guidelines and the investigational plan and protocols contained
in an Investigational New Drug application, or comparable
foreign regulatory submission. Furthermore, these third parties
may also have relationships with other entities, some of which
may be our competitors. In addition, they may not complete
activities on schedule, or may not conduct our pre-clinical
studies or clinical trials in accordance with regulatory
requirements or our trial design. If these third parties do not
successfully carry out their contractual duties or meet expected
deadlines, our efforts to obtain regulatory approvals for, and
commercialize, our product candidates may be delayed or
prevented.
In
carrying out our operations, we are dependent on a stable and
consistent supply of ingredients and raw
materials.
There can be no assurance that we, our contract manufacturers or
our partners, will be able, in the future, to continue to
purchase products from our current suppliers or any other
supplier on terms similar to current terms or at all. An
interruption in the availability of certain raw materials or
ingredients, or significant increases in the prices paid by us
for them, could have a material adverse effect on our business,
financial condition, liquidity and operating results.
The
failure to perform satisfactorily by third parties upon which we
rely to manufacture and supply products may lead to supply
shortfalls.
We rely on third parties to manufacture and supply marketed
products. We also have certain supply obligations
vis-à-vis our licensing partners who are responsible
for the marketing of the products. To be successful, our
products have to be manufactured in commercial quantities in
compliance with quality controls and regulatory requirements.
Even though it is our objective to minimize such risk by
introducing alternative suppliers to ensure a constant supply at
all times, we cannot guarantee that we will not experience
supply shortfalls and, in such event, we may not be able to
perform our obligations under contracts with our partners.
S-14
We are
subject to intense competition for our skilled personnel, and
the loss of key personnel or the inability to attract additional
personnel could impair our ability to conduct our
operations.
We are highly dependent on our management and our clinical,
regulatory and scientific staff, the loss of whose services
might adversely impact our ability to achieve our objectives.
Recruiting and retaining qualified management and clinical,
scientific and regulatory personnel is critical to our success.
Competition for skilled personnel is intense, and our ability to
attract and retain qualified personnel may be affected by such
competition.
Our
strategic partners manufacturing capabilities may not be
adequate to effectively commercialize our product
candidates.
Our manufacturing experience to date with respect to our product
candidates consists of producing drug substance for clinical
studies. To be successful, these product candidates have to be
manufactured in commercial quantities in compliance with
regulatory requirements and at acceptable costs. Our strategic
partners current manufacturing facilities have the
capacity to produce projected product requirements for the
foreseeable future, but we will need to increase capacity if
sales continue to grow. Our strategic partners may not be able
to expand capacity or to produce additional product requirements
on favorable terms. Moreover, delays associated with securing
additional manufacturing capacity may reduce our revenues and
adversely affect our business and financial position. There can
be no assurance that we will be able to meet increased demand
over time.
We are
subject to the risk of product liability claims, for which we
may not have or be able to obtain adequate insurance
coverage.
The sale and use of our products, in particular our
biopharmaceutical products, involve the risk of product
liability claims and associated adverse publicity. Our risks
relate to human participants in our clinical trials, who may
suffer unintended consequences, as well as products on the
market whereby claims might be made directly by patients,
healthcare providers or pharmaceutical companies or others
selling, buying or using our products. We manage our liability
risks by means of insurance. We maintain liability insurance
covering our liability for our pre-clinical and clinical studies
and for our pharmaceutical products already marketed. However,
we may not have or be able to obtain or maintain sufficient and
affordable insurance coverage, including coverage for
potentially very significant legal expenses, and without
sufficient coverage any claim brought against us could have a
materially adverse effect on our business, financial condition
or results of operations.
Our
business involves the use of hazardous materials which requires
us to comply with environmental and occupational safety laws
regulating the use of such materials. If we violate these laws,
we could be subject to significant fines, liabilities or other
adverse consequences.
Our discovery and development processes involve the controlled
use of hazardous and radioactive materials. We are subject to
federal, provincial and local laws and regulations governing the
use, manufacture, storage, handling and disposal of such
materials and certain waste products. The risk of accidental
contamination or injury from these materials cannot be
completely eliminated. In the event of an accident or a failure
to comply with environmental or occupational safety laws, we
could be held liable for any damages that result, and any such
liability could exceed our resources. We may not be adequately
insured against this type of liability. We may be required to
incur significant costs to comply with environmental laws and
regulations in the future, and our operations, business or
assets may be materially adversely affected by current or future
environmental laws or regulations.
Legislative
actions, new accounting pronouncements and higher insurance
costs are likely to impact our future financial position or
results of operations.
Changes in financial accounting standards or implementation of
accounting standards may cause adverse, unexpected revenue or
expense fluctuations and affect our financial position or
results of operations. New pronouncements and varying
interpretations of pronouncements have occurred with greater
frequency and are expected to occur in the future, and we may
make or be required to make changes in our accounting policies
in the future. Compliance with changing regulations of corporate
governance and public disclosure, notably with respect to
internal controls over financial reporting, may result in
additional expenses. Changing laws, regulations and standards
relating to corporate governance and public disclosure are
creating uncertainty for companies such as ours, and insurance
costs are increasing as a result of this uncertainty.
S-15
We are
subject to additional reporting requirements under applicable
Canadian securities laws and the Sarbanes-Oxley Act in the
United States. We can provide no assurance that we will at all
times in the future be able to report that our internal controls
over financial reporting are effective.
As a public company, we are required to comply with
Section 404 of the Sarbanes-Oxley Act
(Section 404) and National Instrument
52-109
Certification of Disclosure in Issuers Annual and
Interim Filings, and we are required to obtain an annual
attestation from our independent auditors regarding our internal
control over financial reporting. In any given year, we cannot
be certain as to the time of completion of our internal control
evaluation, testing and remediation actions or of their impact
on our operations. Upon completion of this process, we may
identify control deficiencies of varying degrees of severity
under applicable SEC and Public Company Accounting Oversight
Board rules and regulations. As a public company, we are
required to report, among other things, control deficiencies
that constitute material weaknesses or changes in internal
controls that, or that are reasonably likely to, materially
affect internal controls over financial reporting. A
material weakness is a deficiency, or a combination
of deficiencies, in internal control over financial reporting,
such that there is a reasonable possibility that a material
misstatement of the companys annual financial statements
will not be prevented or detected on a timely basis. If we fail
to comply with the requirements of Section 404, Canadian
requirements or report a material weakness, we might be subject
to regulatory sanction and investors may lose confidence in our
financial statements, which may be inaccurate if we fail to
remedy such material weakness.
It is
possible that we may be passive foreign investment company,
which could result in adverse tax consequences to U.S.
investors.
Adverse U.S. federal income tax rules apply to U.S.
Holders (as defined in
Item 10.E Taxation
Certain U.S. Federal Income Tax Consideration in our
Annual Report on
Form 20-F)
that directly or indirectly hold Common Shares or warrants of a
passive foreign investment company (PFIC). We will
be classified as a PFIC for U.S. federal income tax purposes for
a taxable year if (i) at least 75 percent of our gross
income is passive income or (ii) at least
50 percent of the average value of our assets, including
goodwill (based on annual quarterly average), is attributable to
assets which produce passive income or are held for the
production of passive income.
We believe that we were not a PFIC for the 2010 taxable year.
However, since the fair market value of our assets may be
determined in large part by the market price of our Common
Shares, which is likely to fluctuate, and the composition of our
income and assets will be affected by how, and how quickly, we
spend any cash that is raised in any financing transaction, no
assurance can be provided that we will not be classified as a
PFIC for the 2011 taxable year and for any future taxable year.
PFIC characterization could result in adverse U.S. federal
income tax consequences to U.S. Holders. In particular, absent
certain elections, a U.S. Holder would be subject to U.S.
federal income tax at ordinary income tax rates, plus a possible
interest charge, in respect of a gain derived from a disposition
of our Common Shares, as well as certain distributions by us. If
we are treated as a PFIC for any taxable year, a U.S. Holder may
be able to make an election to mark to market Common
Shares each taxable year and recognize ordinary income pursuant
to such election based upon increases in the value of the Common
Shares. However, a
mark-to-market
election is not available to be made in respect of a warrant.
Under recently enacted U.S. tax legislation and subject to
future guidance, if we are a PFIC, U.S. Holders will be required
to file, for returns due after March 18, 2010, an annual
information return with the Internal Revenue Service relating to
their ownership of our Common Shares. Although expected, no
guidance has yet been issued about such return, including on the
information required to be reported on such return, the form of
the return, or the due date of the return.
For a more detailed discussion of the potential tax impact of us
being a PFIC, see Item 10.E
Taxation Certain U.S. Federal Income Tax
Considerations in our Annual Report on
Form 20-F.
We
will report under International Financial Reporting Standards
for our interim and annual consolidated financial statements for
the financial year ending December 31, 2011.
Effective January 1, 2011, the Accounting Standards Board
of the Canadian Institute of Chartered Accountants require that
Canadian publicly accountable enterprises adopt International
Financial Reporting Standards (IFRS), as issued by
the International Accounting Standards Board. We are thus
required to report under IFRS for our interim and annual
consolidated financial statements for the financial year ending
December 31, 2011.
S-16
IFRS uses a conceptual framework that is similar to Canadian
generally accepted accounting principles; however, we have
identified certain differences that will result in changes to
some of our accounting policies. We are currently in the process
of preparing our first interim unaudited financial statements in
accordance with IFRS, and the notes to such financial statements
will explain in detail the specific impact of IFRS on our
financial statements. Additional information on our conversion
to IFRS is provided in our Managements Discussion and
Analysis for the three- and nine-month periods ended
September 30, 2010 and 2009, which is incorporated by
reference into this prospectus supplement and the accompanying
prospectus.
We may
incur losses associated with foreign currency
fluctuations.
Our operations are in many instances conducted in currencies
other than the euro, our functional currency. Fluctuations in
the value of currencies could cause us to incur currency
exchange losses. We do not currently employ a hedging strategy
against exchange rate risk. We cannot assert with any assurance
that we will not suffer losses as a result of unfavorable
fluctuations in the exchange rates between the United States
dollar, the euro, the Canadian dollar and other currencies.
We may
not be able to successfully integrate acquired
businesses.
Future acquisitions may not be successfully integrated. The
failure to successfully integrate the personnel and operations
of businesses which we may acquire in the future with ours could
have a material adverse effect on our operations and results.
Risks
Related to the Common Shares and the Offering
Our
share price is volatile, which may result from factors outside
of our control. If our Common Shares were to be delisted from
NASDAQ or TSX, investors may have difficulty in disposing of our
Common Shares held by them.
Our Common Shares are currently listed and traded only on NASDAQ
and TSX. Our valuation and share price since the beginning of
trading after our initial listings, first in Canada and then in
the United States, have had no meaningful relationship to
current or historical financial results, asset values, book
value or many other criteria based on conventional measures of
the value of shares.
During the year ended December 31, 2010, the closing price
of our Common Shares ranged from $0.79 to $2.09 on NASDAQ and
from C$0.80 to C$2.14 per share on TSX. Our share price may be
affected by developments directly affecting our business and by
developments out of our control or unrelated to us. The stock
market generally, and the biopharmaceutical sector in
particular, are vulnerable to abrupt changes in investor
sentiment. Prices of shares and trading volume of companies in
the biopharmaceutical industry can swing dramatically in ways
unrelated to, or that bear a disproportionate relationship to,
operating performance. Our share price and trading volume may
fluctuate based on a number of factors including, but not
limited to:
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clinical and regulatory developments regarding our product
candidates;
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delays in our anticipated development or commercialization
timelines;
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developments regarding current or future third-party
collaborators;
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other announcements by us regarding technological, product
development or other matters;
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arrivals or departures of key personnel;
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governmental or regulatory action affecting our product
candidates and our competitors products in the United
States, Canada and other countries;
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developments or disputes concerning patent or proprietary rights;
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actual or anticipated fluctuations in our revenues or expenses;
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general market conditions and fluctuations for the emerging
growth and biopharmaceutical market sectors; and
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economic conditions in the United States, Canada or abroad
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Our listing on both NASDAQ and TSX may increase price volatility
due to various factors, including different ability to buy or
sell our Common Shares, different market conditions in different
capital markets and different trading volumes. In addition, low
trading volume may increase the price volatility of our Common
Shares. A thin trading market could cause the price of our
Common Shares to fluctuate significantly more than the stock
market as a whole.
S-17
In the past, following periods of large price declines in the
public market price of a companys securities, securities
class action litigation has often been initiated against that
company. Litigation of this type could result in substantial
costs and diversion of managements attention and
resources, which would adversely affect our business. Any
adverse determination in litigation could also subject us to
significant liabilities.
We must meet continuing listing requirements to maintain the
listing of our Common Shares on NASDAQ and TSX. For continued
listing, NASDAQ requires, among other things, that listed
securities maintain a minimum closing bid price of not less than
$1.00 per share. On January 22, 2010, we announced that we
had received a letter from the NASDAQ Listing Qualifications
Department indicating that the minimum closing bid price of the
Common Shares had fallen below $1.00 for 30 consecutive trading
days, and therefore, Aeterna Zentaris was not in compliance with
NASDAQ Listing Rule 5450(a)(1) (the Rule). In
accordance with NASDAQ Listing Rule 5810(C)(3)(a), we were
provided a grace period of 180 calendar days, or until
July 20, 2010, to regain compliance with this requirement.
On April 27, 2010, we announced that we had received a
letter from NASDAQ notifying us that the closing bid price of
our Common Shares was above $1.00 for ten consecutive trading
days and that, as a result, we had regained compliance with the
Rule as of April 23, 2010.
If we are unsuccessful in maintaining the minimum bid
requirements set forth in the Rule in the future and are unable
to subsequently regain compliance within the applicable grace
period, our Common Shares will be subject to delisting from the
NASDAQ Global Market. Should we receive a delisting
notification, we may appeal to the Listing Qualifications Panel
or apply to transfer the listing of our Common Shares to the
NASDAQ Capital Market if we satisfy at such time all of the
initial listing standards on the NASDAQ Capital Market, other
than compliance with the minimum closing bid price requirement.
If the application to the NASDAQ Capital Market is approved,
then we will have an additional
180-day
grace period in order to regain compliance with the minimum bid
price requirement while listed on the NASDAQ Capital Market.
There can be no assurance that we will meet the requirements for
continued listing on the NASDAQ Global Market or whether our
application to the NASDAQ Capital Market will be approved or
that any appeal would be granted by the Listing Qualifications
Panel.
We may
invest or spend the proceeds of any offering of securities under
this prospectus supplement and the accompanying prospectus in
ways with which investors may not agree and in ways that may not
earn a profit.
Our management team will have broad discretion concerning the
use of the proceeds of any offering of securities under this
prospectus supplement and the accompanying prospectus as well as
the timing of their expenditure. As a result, investors will be
relying on the judgment of management for the application of the
proceeds of any offering of Common Shares under the Sales
Agreement and under this prospectus supplement and the
accompanying prospectus. We intend to use the proceeds from any
offering primarily for general corporate purposes, which may
include, but are not limited to, our current clinical
development programs. Investors may not agree with the ways we
decide to use these proceeds, and our use of the proceeds may
not yield any results or profits.
You
may incur substantial dilution.
The current trading price of our Common Shares is substantially
higher than the pro forma negative net tangible book value per
share of our outstanding Common Shares. Consequently, if an
investor were to purchase our Common Shares at an assumed
offering price of $1.70, being the last reported sale price of
our Common Shares on NASDAQ prior to the date of this prospectus
supplement, you would incur substantial dilution. See
Consolidated Capitalization and Dilution.
Future
issuances of securities may depress the trading price of our
Common Shares.
Any additional or future issuance of equity securities or
securities convertible into or exchangeable for equity
securities, including the issuance of Common Shares upon the
exercise of stock options and upon exercise of warrants, could
dilute the interests of our existing equity securityholders, and
could substantially decrease the trading price of our Common
Shares. Apart from the Common Shares offered under this
prospectus supplement, we may issue equity securities in the
future for a number of reasons, including to finance our
operations and business strategy, to satisfy our obligations
upon the exercise of options or warrants or for other reasons.
Our stock option plan generally permits us to have outstanding,
at any given time, stock options that are exercisable for a
maximum number of Common Shares equal to 11.4% of all then
issued and outstanding Common Shares. As at September 30,
2010, there were:
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83,147,463 Common Shares issued and outstanding;
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no issued and outstanding preferred shares;
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13,105,540 Common Shares issuable upon exercise of outstanding
warrants;
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S-18
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6,177,289 stock options outstanding; and
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3,301,521 stock options that remained available for granting
under our stock option plan.
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We do
not intend to pay dividends in the near future.
To date, we have not declared or paid any dividends on our
Common Shares. We currently intend to retain our future
earnings, if any, to finance further research and the expansion
of our business. As a result, the return on an investment in our
securities will, for the foreseeable future, depend upon any
future appreciation in value. There is no guarantee that our
securities will appreciate in value or even maintain the price
at which shareholders have purchased their securities.
USE OF
PROCEEDS
Except as otherwise provided in any free writing prospectus that
we may authorize to be provided to you, we will use the net
proceeds from the sale of the Common Shares for general
corporate purposes, which may include research and development
expenses, clinical trial expenses, and increasing our working
capital. Pending the application of the net proceeds, we expect
to invest the proceeds in investment grade, interest bearing
securities.
As of the date of this prospectus supplement, we cannot specify
with certainty all of the particular uses for the net proceeds
we will have upon completion of this offering. Accordingly, our
management will have broad discretion in the application of net
proceeds, if any.
PRICE
RANGE AND TRADING VOLUME
Our Common Shares are listed and posted for trading on NASDAQ
under the symbol AEZS and on TSX under the symbol
AEZ. The following table indicates, for the relevant
periods, the high and low closing prices and the average daily
trading volume of our Common Shares on NASDAQ and on TSX:
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NASDAQ (US$)
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TSX (C$)
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High
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Low
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Volume
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High
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Low
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Volume
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2010
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Full Year 2010
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2.09
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0.79
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2,178,472
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2.14
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0.80
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264,861
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Fourth quarter
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1.96
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1.22
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1,942,177
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1.98
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1.22
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186,524
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Third quarter
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1.40
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0.95
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1,453,461
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1.44
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1.00
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127,997
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Second quarter
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2.09
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0.80
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5,006,577
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2.14
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0.80
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666,192
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First quarter
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0.93
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0.79
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266,228
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0.99
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0.81
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75,727
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Last twelve months
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Feb-111
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1.81
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1.56
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1,446,245
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1.80
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1.55
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148,514
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Jan-11
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1.77
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1.55
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1,241,150
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1.77
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1.54
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103,555
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Dec-10
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1.96
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1.41
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2,817,574
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1.98
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1.44
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299,924
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Nov-10
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1.45
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1.22
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1,919,860
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1.49
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1.22
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178,314
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Oct-10
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1.32
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1.22
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1,047,410
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1.33
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1.24
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76,485
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Sept-10
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1.40
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1.03
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2,128,723
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1.44
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1.08
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183,881
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Aug-10
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1.17
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0.95
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981,948
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1.21
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1.00
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88,405
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Jul-10
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1.19
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1.02
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1,272,165
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1.24
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1.08
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111,705
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Jun-10
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1.78
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1.12
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2,538,998
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1.88
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1.15
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266,000
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May-10
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2.09
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1.21
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7,920,290
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2.14
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1.23
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884,790
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Apr-10
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1.65
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0.80
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4,816,695
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1.66
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0.80
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877,252
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Mar-10
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0.85
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0.79
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217,325
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0.87
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0.81
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77,730
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Feb-10
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0.87
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0.81
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102,265
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0.91
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0.86
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38,021
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(1) |
Up to and including February 18, 2011.
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S-19
PRIOR
SALES
On April 20, 2010, we completed a registered direct
offering pursuant to which we issued 11,111,111 units, each unit
being comprised of one Common Share and one warrant to purchase
0.40 of a Common Share, for a price of $1.35 per unit. Each such
warrant has an exercise price of $1.50 per share. On
June 15, 2010, we completed a registered direct offering
pursuant to which we issued 8,805,964 units, each unit being
comprised of one Common Share and one warrant to purchase 0.50
of a Common Share, for a price of $1.3725 per unit (the
June 2010 Offering). Each such warrant has an
exercise price of $1.3725 per share. We also issued compensation
warrants to purchase up to an aggregate of 264,178 Common Shares
to Rodman & Renshaw, LLC (and certain of its
representatives), who acted as placement agent for the June 2010
Offering, which warrants have an exercise price of $1.7156 per
Common Share.
In addition, during the year ended December 31, 2010, we
granted an aggregate of 1,088,525 stock options, being comprised
of 25,000 stock options exercisable at C$1.79 per share, 160,000
stock options exercisable at C$1.39 per share and 903,525 stock
options exercisable at C$1.52 per share.
CONSOLIDATED
CAPITALIZATION AND DILUTION
The following table presents the number of our issued and
outstanding Common Shares and our consolidated cash and cash
equivalents and capitalization as at September 30, 2010 on
an actual basis and as adjusted to give effect to the sale of
our Common Shares in the aggregate amount of $19.8 million
at an assumed offering price of $1.70 per share, the last
reported sale price of our Common Shares on NASDAQ on
February 18, 2011. The adjustments present the expected
impact on the number of our issued and outstanding shares, our
consolidated cash and cash equivalents and our capitalization as
at September 30, 2010 of the issuances described above and
after the payment by us of MLVs fees and estimated
transaction expenses. There has been no material change to our
share capital since September 30, 2010. In addition, as at
September 30, 2010, we had no outstanding long-term debt.
The information below should be read in conjunction with, and is
qualified in its entirety by, the audited consolidated financial
statements and schedules and notes thereto included in our
annual report on
Form 20-F
for the financial year ended December 31, 2009, and our
unaudited interim consolidated financial statements as at
September 30, 2010 and for the three- and nine-month
periods ended September 30, 2010 and September 30,
2009 and Managements Discussion and Analysis thereon, each
as incorporated by reference into this prospectus supplement.
Figures are in thousands of U.S. dollars except share data.
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As at September 30, 2010
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Actual
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As
Adjusted(1)
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Number of Common Shares issued and outstanding
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|
|
83,147,463(2
|
)
|
|
|
94,765,598
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
39,866
|
|
|
$
|
58,813
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity:
|
|
|
|
|
|
|
|
|
Share capital and warrants
|
|
$
|
69,265
|
|
|
$
|
88,212
|
|
Other capital
|
|
$
|
80,622
|
|
|
$
|
80,622
|
|
Deficit
|
|
$
|
(148,015
|
)
|
|
$
|
(148,015
|
)
|
Accumulated other comprehensive income
|
|
$
|
12,919
|
|
|
$
|
12,919
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity and total capitalization
|
|
$
|
14,791
|
|
|
$
|
33,738
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
As adjusted assumes and gives effect to the issuance of
11,618,135 Common Shares to be offered from time to time under
this prospectus supplement at an assumed price of $1.70 per
Common Share, the last reported sale price of our Common Shares
on NASDAQ on February 18, 2011, and the payment by us of
MLVs fee and the estimated expenses of the offering.
|
|
(2)
|
In addition, as at September 30, 2010, 13,105,540 Common
Shares were issuable upon exercise of warrants that we
previously issued in various registered direct offerings in June
2009, October 2009, April 2010 and June 2010. As at
September 30, 2010, there were also 6,177,289 Common Shares
that underlie outstanding stock options granted under our stock
option plan.
|
If you purchase Common Shares in this offering, your interest
will be diluted to the extent of the excess of the public
offering price per common share over the as adjusted negative
net tangible book value per common share after this offering.
Negative net tangible book value per share represents the amount
of our total tangible assets (which include unrestricted and
restricted cash and cash equivalents, accounts receivable,
income taxes, inventory, and property, plant and equipment)
reduced by the amount of our total liabilities, divided by the
total number of Common Shares issued and outstanding.
S-20
As at September 30, 2010, we had a negative net tangible
book of $15.7 million, or approximately $0.19 per Common
Share. Net tangible book value per share is calculated by
subtracting our total liabilities from our total tangible
assets, which is total assets less intangible assets, and
dividing this amount by the number of Common Shares issued and
outstanding. After giving effect to the sale of our Common
Shares in the aggregate amount of $19.8 million at an assumed
offering price of $1.70 per share, the last reported sale price
of our Common Shares on NASDAQ on February 18, 2011, and
after deducting estimated offering commissions and expenses of
$0.8 million, or $0.07 per share, payable by us, we would
have had a positive net tangible book value as at
September 30, 2010 of $3.2 million, or $0.03 per Common
Share. This represents an immediate increase in the net tangible
book value of $0.22 per share to our existing shareholders
and an immediate and substantial dilution in net tangible book
value of $1.67 per share to new investors. The following
table illustrates this per share dilution:
|
|
|
|
|
|
|
|
|
Assumed offering price per share
|
|
|
|
|
|
$
|
1.70
|
|
Net tangible book value per share as at September 30, 2010
|
|
$
|
(0.19
|
)
|
|
|
|
|
Increase in net tangible book value per share attributable to
this offering
|
|
$
|
0.22
|
|
|
|
|
|
As-adjusted net tangible book value per share after this offering
|
|
|
|
|
|
$
|
0.03
|
|
|
|
|
|
|
|
|
|
|
Net dilution per share to new investors
|
|
|
|
|
|
$
|
1.67
|
|
|
|
|
|
|
|
|
|
|
The table above assumes for illustrative purposes that an
aggregate of 11,618,135 of our Common Shares are sold at a price
of $1.70 per share, the last reported sale price of our
Common Shares on NASDAQ on February 18, 2011, for aggregate
gross proceeds of $19.8 million. The Common Shares sold in
this offering, if any, will be sold from time to time at various
prices. An increase of $0.10 per share in the price at
which the Common Shares are sold from the assumed offering price
of $1.70 per share shown in the table above, assuming all
of our Common Shares in the aggregate amount of
$19.8 million are sold at that price, would increase the
dilution in net tangible book value per share to new investors
in this offering to $1.77 per share, after deducting
commissions and estimated aggregate offering expenses payable by
us. A decrease of $0.10 per share in the price at which the
Common Shares are sold from the assumed offering price of
$1.70 per share shown in the table above, assuming all of
our Common Shares in the aggregate amount of $19.8 million
are sold at that price, would decrease the dilution in net
tangible book value per share to new investors in this offering
to $1.57 per share, after deducting commissions and
estimated aggregate offering expenses payable by us. This
information is supplied for illustrative purposes only.
The calculations above are based upon 83,147,463 Common Shares
issued and outstanding as at September 30, 2010 and exclude:
|
|
|
|
|
stock options representing the right to purchase a total of
293,334 Common Shares at a weighted average exercise price of
$2.83 per share;
|
|
|
|
stock options representing the right to purchase a total of
5,883,955 Common Shares at a weighted average exercise price of
C$2.70 per share;
|
|
|
|
3,301,521 Common Shares which were reserved for future stock
option grants available under our stock option grant; and
|
|
|
|
warrants representing the right to purchase a total of
13,105,540 Common Shares at a weighted average exercise price of
$1.53 per share.
|
DIVIDEND
POLICY
We have never declared or paid dividends on our Common Shares.
We currently expect to retain future earnings, if any, for use
in the operation and expansion of our business and do not
anticipate paying any cash dividends in the foreseeable future.
Any future determination to pay dividends on our Common Shares
is subject to the discretion of our Board of Directors and will
depend upon various factors, including, without limitation, our
results of operations and financial condition.
S-21
DESCRIPTION
OF SECURITIES OFFERED UNDER THIS PROSPECTUS SUPPLEMENT
Share
Capital
Our authorized share capital structure consists of an unlimited
number of shares of the following classes (all classes are
without nominal or par value): Common Shares; and first
preferred shares (the First Preferred Shares) and
second preferred shares (the Second Preferred Shares
and, together with the First Preferred Shares, the
Preferred Shares), both issuable in series. As at
September 30, 2010, there were 83,147,463 Common Shares
issued and outstanding. No Preferred Shares of the Company have
been issued to date.
Common
Shares
The holders of the Common Shares are entitled to one vote for
each common share held by them at all meetings of shareholders,
except meetings at which only shareholders of a specified class
of shares are entitled to vote. In addition, the holders are
entitled to receive dividends if, as and when declared by the
Companys Board of Directors on the Common Shares. Finally,
the holders of the Common Shares are entitled to receive the
remaining property of the Company upon any liquidation,
dissolution or
winding-up
of the affairs of the Company, whether voluntary or involuntary.
Shareholders have no liability to further capital calls as all
issued and outstanding shares are fully paid and non-assessable.
Additional information on our share capital is provided in
Item 10. Additional Information in
our Annual Report on
Form 20-F
for the financial year ended December 31, 2009 and is
incorporated by reference into this prospectus supplement.
PLAN OF
DISTRIBUTION
We have entered into a Sales Agreement with MLV under which we
may issue and sell from time to time through MLV, acting as
agent, up to 12,500,000 Common Shares. A form of the Sales
Agreement has been furnished to the SEC as Exhibit 99.2 to our
Report on
Form 6-K
dated February 22, 2011 and is incorporated herein by
reference. The sales, if any, of Common Shares made under the
Sales Agreement will be made in the United States only by any
method permitted by law deemed to be an at the
market offering as defined in Rule 415 of the
Securities Act, including without limitation sales made directly
on NASDAQ or on any other existing trading market for the Common
Shares in the United States. We may instruct MLV not to sell
Common Shares if the sales cannot be effected at or above the
price designated by us from time to time. We or MLV may suspend
the offering of Common Shares upon notice and subject to other
conditions. Neither MLV, any affiliate of MLV nor any person or
company acting jointly or in concert with MLV, has
over-allotted, or will over-allot, Common Shares in connection
with this offering or effect any other transactions that are
intended to stabilize or maintain the market price of the Common
Shares.
We will pay MLV commissions for its services in acting as agent
in the sale of Common Shares. MLV will be entitled to
compensation at a fixed commission rate of three percent (3%) of
the gross proceeds from the sale of such Common Shares. We
estimate that the total expenses for the offering, excluding
compensation payable to MLV under the terms of the Sales
Agreement, will be approximately $0.2 million. The maximum
compensation to be received by any broker/dealer or sales agent
will not be greater than 8.0% for the sale of any securities
being registered pursuant to Rule 415 under the Securities
Act.
Settlement for sales of Common Shares will occur on the third
business day following the date on which any sales are made, or
on some other date that is agreed upon by us and MLV in
connection with a particular transaction, in return for payment
of the net proceeds to us.
MLV will act as sales agent and will use its commercially
reasonable efforts consistent with its normal trading and sales
practices to sell the Common Shares. In connection with the sale
of the Common Shares on our behalf, MLV will be deemed to be an
underwriter within the meaning of the Securities Act
and the compensation of MLV will be deemed to be underwriting
commissions or discounts. We have agreed to provide
indemnification and contribution to MLV against certain civil
liabilities, including liabilities under the Securities Act. If
by December 31, 2011 we have not sold Common Shares under
the Sales Agreement having aggregate proceeds of at least
$6,000,000, subject to certain exceptions, we will be obligated
to reimburse MLV for reasonable
out-of-pocket
expenses up to a maximum of $50,000.
The offering pursuant to the Sales Agreement will terminate on
the two-year anniversary of the date of the Sales Agreement or
earlier upon (i) the sale of all Common Shares subject to
the agreement, or (ii) termination of the Sales Agreement
by the Company or MLV as permitted therein. MLV may also
terminate the Agreement in certain circumstances, including the
occurrence of a material adverse change that, in MLVs
reasonable judgment, may impair
S-22
its ability to sell the Common Shares or a suspension or
limitation of trading of the Companys Common Shares on
NASDAQ. In addition, either the Company or MLV may terminate the
Agreement at any time and for any reason upon ten days
prior notice to the other party.
The address of MLV is 420 Lexington Avenue, Suite 628, New
York, NY 10170.
MLV and its affiliates may in the future provide various
investment banking and other financial services for us and our
affiliates, for which services they may in the future receive
customary fees. To the extent required by Regulation M, MLV
will not engage in any market making activities involving our
Common Shares while the offering is ongoing under this
prospectus supplement.
CERTAIN
INCOME TAX CONSIDERATIONS
United
States Federal Income Taxation
The following discussion is a summary of certain U.S. federal
income tax consequences applicable to the purchase, ownership
and disposition of Common Shares by a U.S. Holder (as defined
below), but does not purport to be a complete analysis of all
potential U.S. federal income tax effects. This summary is based
on the Internal Revenue Code of 1986, as amended (the
Code), U.S. Treasury regulations promulgated
thereunder, Internal Revenue Service (IRS) rulings
and judicial decisions in effect as of the date of this
prospectus supplement. All of these are subject to change,
possibly with retroactive effect, or different interpretations.
This summary does not address all aspects of U.S. federal income
taxation that may be relevant to particular U.S. Holders in
light of their specific circumstances (for example, U.S. Holders
subject to the alternative minimum tax provisions of the Code)
or to holders that may be subject to special rules under U.S.
federal income tax law, including:
|
|
|
|
|
dealers in stocks, securities or currencies;
|
|
|
|
securities traders that use a
mark-to-market
accounting method;
|
|
|
|
banks and financial institutions;
|
|
|
|
insurance companies;
|
|
|
|
regulated investment companies;
|
|
|
|
real estate investment trusts;
|
|
|
|
tax-exempt organizations;
|
|
|
|
persons holding Common Shares as part of a hedging or conversion
transaction or a straddle;
|
|
|
|
persons who or that are, or may become, subject to the
expatriation provisions of the Code;
|
|
|
|
persons whose functional currency is not the U.S. dollar; and
|
|
|
|
direct, indirect or constructive owners of 10% or more of the
total combined voting power of all classes of our voting stock.
|
This summary also does not discuss any aspect of state, local or
foreign law, or estate or gift tax law as applicable to U.S.
Holders. In addition, this discussion is limited to U.S. Holders
purchasing Common Shares pursuant to this prospectus supplement
and that will hold such Common Shares as capital assets. For
purposes of this summary, U.S. Holder means a
beneficial holder of Common Shares who or that for U.S. federal
income tax purposes is:
|
|
|
|
|
an individual citizen or resident of the United States;
|
|
|
|
a corporation or other entity classified as a corporation for
U.S. federal income tax purposes created or organized in or
under the laws of the United States, any state thereof or the
District of Columbia;
|
|
|
|
an estate, the income of which is subject to U.S. federal income
taxation regardless of its source; or
|
|
|
|
a trust, if a court within the United States is able to exercise
primary supervision over the administration of such trust and
one or more U.S. persons (within the meaning of the
Code) have the authority to control all substantial decisions of
the trust, or if a valid election is in effect to be treated as
a U.S. person for U.S. federal income tax purposes.
|
If a partnership or other entity or arrangement classified as a
partnership for U.S. federal income tax purposes holds Common
Shares, the U.S. federal income tax treatment of a partner
generally will depend on the status of the partner and
S-23
the activities of the partnership. This summary does not address
the tax consequences to any such partner. Such a partner should
consult its own tax advisor as to the tax consequences of the
partnership purchasing, owning and disposing of Common Shares.
PROSPECTIVE U.S. INVESTORS SHOULD CONSULT THEIR OWN TAX ADVISORS
WITH REGARD TO THE APPLICATION OF THE TAX CONSEQUENCES DESCRIBED
BELOW TO THEIR PARTICULAR SITUATIONS AS WELL AS THE APPLICATION
OF ANY STATE, LOCAL, FOREIGN OR OTHER TAX LAWS, INCLUDING GIFT
AND ESTATE TAX LAWS.
Taxation
of U.S. Holders of Common Shares
Dividends
Subject to the PFIC rules discussed below, any distributions
paid by the Company out of current or accumulated earnings and
profits (as determined for U.S. federal income tax purposes),
before reduction for any Canadian withholding tax paid with
respect thereto, will generally be taxable to a U.S. Holder as
foreign source dividend income, and will not be eligible for the
dividends received deduction generally allowed to corporations.
Distributions in excess of current and accumulated earnings and
profits will be treated as a non-taxable return of capital to
the extent of the U.S. Holders adjusted tax basis in the
Common Shares and thereafter as capital gain. Prospective
purchasers should consult their own tax advisors with respect to
the appropriate U.S. federal income tax treatment of any
distribution received from the Company.
For taxable years beginning before January 1, 2013,
dividends paid by the Company should be taxable to a
non-corporate U.S. Holder at the special reduced rate normally
applicable to long term capital gains, provided that certain
conditions are satisfied. A U.S. Holder will not be able to
claim the reduced rate if the Company is treated as a PFIC for
the taxable year in which the dividend is paid or the preceding
year. See Passive Foreign Investment Company
Considerations below.
Under current law, payments of dividends by the Company to
non-Canadian investors are generally subject to a
25 percent Canadian withholding tax. The rate of
withholding tax applicable to U.S. Holders that are eligible for
benefits under the
Canada-United
States Tax Convention (the Convention) is reduced to
a maximum of 15 percent. This reduced rate of withholding
will not apply if the dividends received by a U.S. Holder are
effectively connected with a permanent establishment of the U.S.
Holder in Canada. For U.S. federal income tax purposes, U.S.
Holders will be treated as having received the amount of
Canadian taxes withheld by the Company, and as then having paid
over the withheld taxes to the Canadian taxing authorities. As a
result of this rule, the amount of dividend income included in
gross income for U.S. federal income tax purposes by a U.S.
Holder with respect to a payment of dividends may be greater
than the amount of cash actually received (or receivable) by the
U.S. Holder from the Company with respect to the payment.
A U.S. Holder will generally be entitled, subject to certain
limitations, to a credit against its U.S. federal income tax
liability, or a deduction in computing its U.S. federal taxable
income, for Canadian income taxes withheld by the Company. For
purposes of the foreign tax credit limitation, dividends paid by
the Company generally will constitute foreign source income in
the passive category income basket.
Prospective purchasers should consult their tax advisors
concerning the foreign tax credit implications of the payment of
Canadian taxes.
Dividends paid in Canadian dollars will be included in the gross
income of the U.S. Holder in a U.S. dollar amount calculated by
reference to the exchange rate in effect on the date the U.S.
Holder receives the dividend, regardless of whether such
Canadian dollars are actually converted into U.S. dollars at
that time. Gain or loss, if any, realized on a sale or other
disposition of the Canadian dollars will generally be U.S.
source ordinary income or loss to a U.S. Holder.
The Company generally does not pay any dividends and does not
anticipate paying any dividends in the foreseeable future.
Sale or
Other Taxable Disposition
Subject to the PFIC rules discussed below, upon a sale or other
taxable disposition of Common Shares, a U.S. Holder generally
will recognize capital gain or loss for U.S. federal income tax
purposes equal to the difference, if any, between the amount
realized on the sale or other taxable disposition and the U.S.
Holders adjusted tax basis in the Common Shares.
S-24
This capital gain or loss will be long-term capital gain or loss
if the U.S. Holders holding period in the Common Shares
exceeds one year. For taxable years beginning before
January 1, 2013, the rates of taxation for long-term
capital gains of non-corporate U.S. Holders are reduced compared
to such rates thereafter provided that certain conditions are
satisfied. The deductibility of capital losses is subject to
limitations. Any gain or loss will generally be U.S. source for
U.S. foreign tax credit purposes.
Passive
Foreign Investment Company Considerations
A foreign corporation will be classified as a PFIC for any
taxable year in which, after taking into account the income and
assets of the corporation and certain subsidiaries pursuant to
applicable look-through rules, either (i) at
least 75% of its gross income is passive income or
(ii) at least 50% of the average value of its assets is
attributable to assets which produce passive income or are held
for the production of passive income.
The Company believes it was not a PFIC for the 2010 taxable
year. However, since the fair market value of the Companys
assets may be determined in large part by the market price of
the Common Shares, which is likely to fluctuate, and the
composition of the Companys income and assets will be
affected by how, and how quickly, the Company spends any cash
that is raised in any financing transaction, no assurance can be
provided that the Company would not be classified as a PFIC for
the 2011 taxable year and for any future taxable year.
If the Company is classified as a PFIC for any taxable year
during which a U.S. Holder owns Common Shares, the U.S. Holder,
absent certain elections (including the
mark-to-market
election described below), will generally be subject to adverse
rules (regardless of whether the Company continues to be
classified as a PFIC) with respect to (i) any excess
distributions (generally, any distributions received by
the U.S. Holder on the Common Shares in a taxable year that are
greater than 125% of the average annual distributions received
by the U.S. Holder in the three preceding taxable years or, if
shorter, the U.S. Holders holding period for the Common
Shares) and (ii) any gain realized on the sale or other
disposition of Common Shares.
Under these adverse rules (a) the excess distribution or
gain will be allocated ratably over the U.S. Holders
holding period, (b) the amount allocated to the current
taxable year and any taxable year prior to the first taxable
year in which the Company is classified as a PFIC will be taxed
as ordinary income, and (c) the amount allocated to each of
the other taxable years during which the Company was classified
as a PFIC will be subject to tax at the highest rate of tax in
effect for the applicable class of taxpayer for that year and an
interest charge will be imposed with respect to the resulting
tax attributable to each such other taxable year.
U.S. Holders can avoid the interest charge described above by
making a
mark-to-market
election with respect to the Common Shares, provided that the
Common Shares are marketable. Common. shares will be
marketable if they are regularly traded on a qualified exchange
or other market. For this purpose, Common Shares generally will
be considered to be regularly traded during any calendar year
during which they are traded, other than in de minimis
quantities, on at least 15 days during each calendar
quarter. The Common Shares are currently listed and regularly
traded on NASDAQ, which constitutes a qualified exchange. If the
Common Shares were delisted from the NASDAQ and were not traded
on another qualified exchange for the requisite time period
described above, the
mark-to-market
election would not be available.
A U.S. Holder that makes a
mark-to-market
election must include in gross income, as ordinary income, for
each taxable year an amount equal to the excess, if any, of the
fair market value of the Common Shares at the close of the
taxable year over the U.S. Holders adjusted tax basis in
the Common Shares. An electing U.S. Holder may also claim an
ordinary loss deduction for the excess, if any, of the U.S.
Holders adjusted tax basis in the Common Shares over the
fair market value of the Common Shares at the close of the
taxable year, but this deduction is allowable only to the extent
of any net
mark-to-market
gains for prior taxable years. A U.S. Holder that makes a
mark-to-market
election generally will adjust such U.S. Holders tax basis
in the Common Shares to reflect the amount included in gross
income or allowed as a deduction because of such
mark-to-market
election. Gains from an actual sale or other disposition of the
Common Shares will be treated as ordinary income, and any losses
incurred on a sale or other disposition of the Common Shares
will be treated as ordinary losses to the extent of any net
mark-to-market
gains for prior taxable years.
A
mark-to-market
election will be effective for the taxable year for which the
election is made and all subsequent taxable years. The election
cannot be revoked without the consent of the IRS unless the
Common Shares cease to be marketable, in which case the election
is automatically terminated. If the Company is classified as a
PFIC for any taxable year in which a U.S. Holder owns Common
Shares but before a
mark-to-market
election is made, the interest charge rules described above will
apply to any
mark-to-market
gain recognized in the year the election is made.
S-25
In some cases, a shareholder of a PFIC can avoid the interest
charge and the other adverse PFIC consequences described above
by making a qualified electing fund (QEF) election
to be taxed currently on its share of the PFICs
undistributed income. If the Company is classified as a PFIC, it
does not, however, expect to provide the information regarding
its income that would be necessary in order for a U.S. Holder to
make a QEF election with respect to Common Shares.
If the Company is classified as a PFIC, a U.S. Holder of Common
Shares will generally be treated as owning stock owned by the
Company in any direct or indirect subsidiaries that are also
PFICs and will be subject to similar adverse rules with respect
to distributions to the Company by, and dispositions by the
Company of the stock of such subsidiaries. A
mark-to-market
election is not permitted for the shares of any subsidiary of
the Company that is also classified as a PFIC.
If the Company is classified as a PFIC and then ceases to be so
classified, a U.S. Holder may make an election (a deemed
sale election) to be treated for U.S. federal income tax
purposes as having sold such U.S. Holders Common Shares on
the last day of the taxable year of the Company during which it
was a PFIC. A U.S. Holder that made a deemed sale election would
then cease to be treated as owning a stock in a PFIC by reason
of ownership of Common Shares in the Company. However, gain
recognized as a result of making the deemed sale election would
be subject to the adverse rules described above.
Under recently enacted U.S. tax legislation and subject to
future guidance, if the Company is a PFIC, U.S. Holders will be
required to file, for returns due after March 18, 2010, an
annual information return with the IRS relating to their
ownership of Common Shares. This new filing requirement is in
addition to any pre-existing reporting requirements that applied
to a U.S. Holders interest in a PFIC (which the recently
enacted tax legislation does not affect). No additional guidance
has yet been issued about the annual information return required
under the recently enacted legislation, including on the
information required to be reported on such return, the form of
the return, or the due date for the return.
Prospective purchasers should consult their tax advisors
regarding the potential application of the PFIC regime and any
reporting obligations to which they may be subject under that
regime.
Information
Reporting and Backup Withholding
The proceeds of a sale or other disposition of Common Shares, as
well as dividends paid or deemed paid with respect to Common
Shares by a U.S. payor, generally will be reported to the IRS
and to the U.S. Holder as required under applicable regulations.
Backup withholding tax may apply to these payments if the U.S.
Holder fails to timely provide in the appropriate manner an
accurate taxpayer identification number or otherwise fails to
comply with, or establish an exemption from, such backup
withholding tax requirements. Certain U.S. Holders are not
subject to the information reporting or backup withholding tax
requirements described herein. U.S. Holders should consult their
tax advisors as to their qualification for exemption from backup
withholding tax and the procedure for obtaining an exemption.
Backup withholding tax is not an additional tax. U.S. Holders
generally will be allowed a refund or credit against their U.S.
federal income tax liability for amounts withheld, provided the
required information is timely furnished to the IRS.
Subject to specified exceptions and future guidance, recently
enacted U.S. tax legislation generally requires a U.S. Holder
(that is an individual or, to the extent provided in future
guidance, a domestic entity) to report to the IRS such U.S.
Holders interests in stock or securities issued by a
non-U.S.
person (such as the Company) for taxable years beginning after
March 18, 2010. Although expected, no guidance on this
reporting requirement has yet been issued. U.S. Holders should
consult their tax advisors regarding the information reporting
obligations that may arise from their acquisition, ownership or
disposition of Common Shares.
Canadian
Federal Income Tax Considerations for United States
Residents
The following is a general summary, as of the date hereof, of
the principal Canadian federal income tax considerations
generally applicable to the holding and disposition of Common
Shares acquired pursuant to this prospectus supplement by a
holder who, at all relevant times, (a) for the purposes of
the Income Tax Act (Canada) (the Tax Act),
(i) is not resident, or deemed to be resident, in Canada,
(ii) deals at arms length with the Company, and is
not affiliated with the Company, (iii) beneficially owns
Common Shares as capital property, (iv) does not use or
hold the Common Shares in the course of carrying on, or
otherwise in connection with, a business or a part of a business
carried on or deemed to be carried on in Canada and (v) is
not a registered non-resident insurer or
authorized foreign bank within the meaning of the
Tax Act, and (b) for the purposes of the Convention, is a
resident of the United States, has never been a resident of
Canada, does not have and has not had, at any time, a permanent
establishment or fixed base in Canada, and
S-26
who is a qualifying person or otherwise qualifies for the full
benefits of the Convention. Our shares will generally be
considered to be capital property to a holder unless such Common
Shares are held in the course of carrying on a business of
buying or selling securities, or in an adventure or concern in
the nature of trade. Our shares will generally not be capital
property to holders that are financial institutions
(as defined in subsection 142.2(1) of the Tax Act). Holders who
meet all the criteria in clauses (a) and (b) are
referred to herein as a U.S. Shareholder or
U.S. Shareholders. This summary does not deal with
special situations, such as the particular circumstances of
traders or dealers, holders an interest in which is a tax
shelter investment as defined in the Tax Act, tax exempt
entities, insurers or financial institutions. Such holders and
other holders who do not meet the criteria in clauses
(a) and (b) should consult their own tax advisers.
This summary is based upon the current provisions of the Tax Act
and the regulations thereunder (the Regulations) and
the Companys understanding of the current administrative
policies and assessing practices of the Canada Revenue Agency
(CRA) made publicly available prior to the date
hereof. It also takes into account all proposed amendments to
the Tax Act and the Regulations publicly released by the
Minister of Finance (Canada) (Tax Proposals) prior
to the date hereof, and assumes that all such Tax Proposals will
be enacted as currently proposed. No assurance can be given that
the Tax Proposals will be enacted in the form proposed or at
all. This summary does not otherwise take into account or
anticipate any changes in law, whether by way of legislative,
judicial or administrative action or interpretation, nor does it
take into account tax laws of any province or territory of
Canada or of any other jurisdiction outside Canada.
For purposes of the Tax Act, all amounts, including dividends,
adjusted cost base and proceeds of disposition, must generally
be determined in Canadian dollars. Amounts denominated in U.S.
dollars must be converted to Canadian currency using the Bank of
Canada noon rate on the day on which the amount arose or such
other rate of exchange that is acceptable to the Minister of
National Revenue (Canada). The amount of any capital gain or any
capital loss to a U.S. shareholder with respect to the shares
may be affected by fluctuations in Canadian dollar exchange
rates.
This summary is of a general nature only and is not intended
to be, nor should it be construed to be, legal or tax advice to
any particular U.S. Shareholder and no representation with
respect to the federal income tax consequences to any particular
U.S. Shareholder or prospective U.S. Shareholder is made. The
tax consequences to a U.S. Shareholder will depend on the
holders particular circumstances. Accordingly, U.S.
Shareholders should consult with their own tax advisers for
advice with respect to their own particular circumstances.
The cost for Canadian tax purposes to a U.S. Shareholder of a
Common Share must be averaged at the time such Common Share is
acquired with the adjusted cost base of all other Common Shares
held by such U.S. Shareholder as capital property at that time
for purposes of calculating the adjusted cost base of such
Common Shares.
Dividends
Amounts paid or credited or deemed to be paid or credited as, on
account or in lieu of payment, or in satisfaction of, dividends
on our Common Shares to a U.S. Shareholder will be subject to
Canadian withholding tax. Under the Convention, the rate of
Canadian withholding tax on dividends paid or credited by us to
a U.S. Shareholder that beneficially owns such dividends is
generally 15% unless the beneficial owner is a company that owns
at least 10% of our voting stock at that time, in which case the
rate of Canadian withholding tax is reduced to 5%.
Dispositions
A U.S. Shareholder will generally not be subject to tax under
the Tax Act on any capital gain realized on a disposition of our
Common Shares, unless the Common Shares constitute taxable
Canadian property to the U.S. Shareholder at the time of
disposition and the U.S. Shareholder is not entitled to relief
under the Convention. Generally, our Common Shares will not
constitute taxable Canadian property to a U.S. Shareholder
provided they are listed on a designated stock exchange (which
includes TSX and NASDAQ) at the time of the disposition, unless
(a) at any time during the
60-month
period immediately preceding the disposition, the U.S.
Shareholder, persons with whom the U.S. Shareholder does not
deal at arms length, or the U.S. Shareholder together with
such persons, owned 25% or more of the issued shares of any
series or class of our capital stock and more than 50% of the
fair market value of our Common Shares was derived, directly or
indirectly, from a combination of (i) real or immovable
property situated in Canada, (ii) Canadian resource
property (as defined in the Tax Act),
(iii) timber resource property (as defined in
the Tax Act), and (iv) options in respect of, interests in,
or for civil law rights in any such properties whether or not
the property exists, or (b) our Common Shares are otherwise
deemed to be taxable Canadian property to the U.S. Shareholder.
If our Common Shares constitute taxable Canadian property to a
particular U.S. Shareholder, any capital gain arising on their
disposition may be exempt from Canadian tax under the Convention
if, at the time of disposition, our Common Shares do not derive
their value principally from real property situated in Canada as
defined in the Convention.
S-27
As long as our Common Shares are listed at the time of their
disposition on TSX, NASDAQ or another recognized stock
exchange (as defined in the Tax Act), a U.S. Shareholder
who disposes of our Common Shares that are taxable Canadian
property will not be required to apply for and obtain a
certificate of compliance and will not be subject to withholding
by a purchaser under Section 116 of the Tax Act. An
exemption from such obligations may also be available in respect
of such a disposition if the Common Shares are
treaty-protected property (as defined in the Tax
Act) of the disposing U.S. shareholder.
LEGAL
MATTERS
Certain legal matters relating to the offering will be passed
upon for us by Ogilvy Renault LLP with respect to matters of
Canadian law and by Ropes & Gray LLP with respect to
matters of United States law. MLV is being represented in
connection with this offering by Blake, Cassels &
Graydon LLP with respect to matters of Canadian law and
LeClairRyan, P.C. with respect to matters of United States law.
At the date of this prospectus supplement, the partners and
associates of Ogilvy Renault LLP beneficially own, directly or
indirectly, less than 1% of our outstanding securities.
EXPERTS
The consolidated financial statements, financial statement
schedules and managements assessment of the effectiveness
of internal control over financial reporting (which is included
in Managements Report on Internal Control over Financial
Reporting) incorporated into this prospectus supplement by
reference to the Annual Report on
Form 20-F
of Aeterna Zentaris Inc. for the financial year ended
December 31, 2009 have been so incorporated in reliance on
the report of PricewaterhouseCoopers LLP, independent auditors,
given on the authority of said firm as experts in auditing and
accounting.
WHERE YOU
CAN FIND MORE INFORMATION
We file annual reports on
Form 20-F
with the SEC, and we furnish other documents, such as quarterly
and current reports, proxy statements and other information and
documents that we file with the Canadian securities regulatory
authorities, to the SEC, as required. You may read and copy any
materials we file with or furnish to the SEC at the public
reference room maintained by the SEC 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.
In addition, the SEC maintains an Internet site
(http://www.sec.gov)
that contains reports, proxy and information statements and
other information regarding registrants who file electronically
with the SEC.
This prospectus supplement and the accompanying prospectus form
part of a registration statement that we filed with the SEC. The
registration statement contains more information than this
prospectus regarding us and our Common Shares, including certain
exhibits and schedules. You can obtain a copy of the
registration statement from the SEC at the address listed above
or from the SECs Internet site
(http://www.sec.gov).
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
This prospectus supplement and the accompanying prospectus are
part of a registration statement on
Form F-3
filed by us with the SEC. This prospectus supplement and the
accompanying prospectus do not contain all of the information
set forth in the registration statement, certain parts of which
are omitted in accordance with the rules and regulations of the
SEC. Statements contained in this prospectus supplement, the
accompanying prospectus or the documents incorporated by
reference into this prospectus supplement or the accompanying
prospectus as to the contents of any contract or other document
referred to are not necessarily complete and in each instance
reference is made to the copy of that contract or other document
filed with or furnished to the SEC. For further information
about us and the securities offered by this prospectus
supplement, we refer you to the registration statement and its
exhibits and schedules which may be obtained as described herein.
The SEC allows us to incorporate by reference the
information contained in documents that we file with or furnish
to it, which means that we can disclose important information to
you by referring you to those documents. The information
incorporated by reference is considered to be part of this
prospectus supplement and the accompanying prospectus, and
information in documents that we subsequently file with or
furnish to the SEC will automatically update and supersede
information in this prospectus supplement and the accompanying
prospectus. We incorporate by reference the documents listed
below into this prospectus supplement, and any future filings
made by us with the SEC under Section 13(a), 13(c), 14 or
15(d) of the Exchange Act until the offering of all the
securities by this prospectus supplement
S-28
is completed, including all filings made after the date of this
prospectus supplement. We hereby incorporate by reference the
documents listed below (File
No. 000-30752):
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our annual report on
Form 20-F
for the financial year ended December 31, 2009 as filed
with the SEC on March 30, 2010, which includes our audited
consolidated balance sheets as at December 31, 2009 and
2008 and our audited consolidated statements of operations,
comprehensive loss, accumulated other comprehensive income and
deficit, changes in shareholders equity and cash flows for
each of the years in the three-year period ended
December 31, 2009, the financial statement schedules and
managements annual report on internal control over
financial reporting set out on page 116 of our 2009 annual
report on
Form 20-F,
together with the auditors report thereon dated
March 23, 2010 on our consolidated financial statements and
on the effectiveness of internal control over financial
reporting and our Managements Discussion and Analysis
included as Item 5. Operating and
Financial Review and Prospects in our annual report on
Form 20-F;
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our unaudited interim consolidated financial statements as at
March 31, 2010 and for the three-month periods ended
March 31, 2010 and 2009 and Managements Discussion
and Analysis thereon, included as Exhibit 99.1 to our
report on
Form 6-K
furnished to the SEC on May 13, 2010;
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our unaudited interim consolidated financial statements as at
June 30, 2010 and for the three- and six-month periods
ended June 30, 2010 and 2009 and Managements
Discussion and Analysis thereon, included as Exhibit 99.1
to our report on
Form 6-K
furnished to the SEC on August 12, 2010; and
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our unaudited interim consolidated financial statements as at
September 30, 2010 and for the three- and nine-month
periods ended September 30, 2010 and 2009 and
Managements Discussion and Analysis thereon, included as
Exhibit 99.1 to our report on
Form 6-K
furnished to the SEC on November 10, 2010.
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We will provide each person to whom this prospectus supplement
is delivered a copy of all of the information that has been
incorporated by reference in this prospectus supplement or the
accompanying prospectus but not delivered with this prospectus
supplement and the accompanying prospectus. You may obtain
copies of these filings, at no cost, by writing or telephoning
us at:
Aeterna
Zentaris Inc.
Attention: Investor Relations
1405 du Parc-Technologique Boulevard
Quebec City, Quebec
Canada, G1P 4P5
Tel.
(418) 652-8525
S-29
No securities regulatory authority has expressed an opinion about these securities and it is an
offence to claim otherwise.
This short form base shelf prospectus constitutes a public offering of securities only in those
jurisdictions where such securities may be lawfully offered for sale and therein only by persons
permitted to sell such securities and it is an offence to claim otherwise.
Information has been incorporated by reference in this short form base shelf prospectus from
documents filed with securities commissions or similar securities regulatory authorities in
Canada. Copies of the documents incorporated herein by reference may be obtained on request
without charge from the Corporate Secretary of Æterna Zentaris Inc. at 1405 du Parc-Technologique
Blvd., Quebec City, Quebec, Canada G1P 4P5, Tel. (418) 652-8525, and are also available
electronically at www.sedar.com.
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New Issue
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Dated March 12, 2010 |
SHORT FORM BASE SHELF PROSPECTUS
U.S.$60,000,000
Common Shares
Warrants to Purchase Common Shares
We may from time to time during the 25-month period that this short form base shelf
prospectus (the Prospectus), including any amendments, remains valid, offer, sell, and issue
under this Prospectus up to U.S.$60,000,000 aggregate initial offering price of our common shares
(the Common Shares) and/or warrants to purchase Common Shares (the Warrants, and, together with
the Common Shares, the Securities). We may offer Securities from time to time in one or more
transactions in such amounts and, in the case of the Warrants, with such terms, as we may determine
in light of prevailing market conditions at the time of sale. We may sell and issue the Warrants
under this Prospectus in one or more series.
The specific variable terms of any offering of Securities will be set out in the applicable
supplement to this Prospectus (each, a Prospectus Supplement), including, where applicable: (i)
in the case of the Common Shares, the number of Common Shares offered, the offering price, the
currency in which the Common Shares will be issued and any other specific terms; and (ii) in the
case of the Warrants, the designation of the particular series offered, the number of Warrants
offered, the offering price, the currency in which the Warrants will be issued, the number of
Common Shares that may be acquired upon exercise of the Warrants, the exercise price, dates and
periods of exercise, adjustment procedures and any other specific terms applicable thereto.
A Prospectus Supplement may include specific terms pertaining to the Securities that are not
within the alternatives and parameters described in this Prospectus. All shelf information
permitted under applicable laws to be omitted from this Prospectus will be contained in one or more
Prospectus Supplements that will be delivered to purchasers together with this Prospectus. Each
Prospectus Supplement will be incorporated by reference into this Prospectus for the purposes of
securities legislation as of the date of the Prospectus Supplement and only for the purposes of the
distribution of the Securities to which the Prospectus Supplement pertains.
We are a foreign private issuer under United States (U.S.) securities laws. We have prepared
our financial statements in accordance with Canadian generally accepted accounting principles
(GAAP), and they are subject to Canadian auditing and auditor independence standards. Thus, they
may not be comparable to the financial statements of U.S. companies. Information regarding the
impact upon our financial statements of significant differences between Canadian and U.S. GAAP is
contained in the Note 27 entitled Summary of differences between generally accepted accounting
principles in Canada and in the United States to our audited consolidated balance sheets as at
December 31, 2008 and 2007 and our audited consolidated statements of earnings (loss), changes in
shareholders equity, comprehensive income (loss) and cash flows for each of the years in the
three-year period ended December 31, 2008 included in our annual report on Form 20-F (filed in
Canada with the Canadian securities regulatory authorities in lieu of an annual information form),
which was filed with the United States Securities and Exchange Commission (SEC) on March 30, 2009
(available electronically at www.sec.gov) and which is incorporated by reference into this
Prospectus. See Reconciliation to U.S. GAAP.
Owning the Securities may subject you to tax consequences both in Canada and the United
States. This Prospectus and any applicable Prospectus Supplement may not describe these tax
consequences fully. You should read the tax discussion in this Prospectus and any applicable
Prospectus Supplement.
Your ability to enforce civil liabilities under U.S. federal securities laws may be affected
adversely by the fact that we are incorporated under the laws of Canada, many of our officers and
directors and all of the experts named in this Prospectus are residents of Canada or elsewhere
outside of the United States, and a substantial portion of our assets and the assets of such
persons are located outside the United States. See Enforceability of Civil Liabilities.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENCE.
Investing in the Securities
involves risk. See Risk Factors beginning on page 8.
Our outstanding Common Shares are currently listed for trading on the Toronto Stock Exchange
(TSX) under the trading symbol AEZ and on the
NASDAQ Global Market (NASDAQ) under the trading
symbol AEZS. There is currently no market through which the Warrants may be sold and purchasers
may not be able to resell Warrants purchased under this Prospectus. This may affect the pricing of
any Warrants in the secondary market, the transparency and availability of trading prices, the
liquidity of the Warrants, and the extent of issuer regulation. See the Risk Factors section of
the applicable Prospectus Supplement.
As
of March 11, 2010, the aggregate market
value of our outstanding Common Shares held by
non-affiliates was approximately U.S.$37.6 million based on
63.1 million Common
Shares outstanding, of
which approximately 45.7 million Common Shares are held by non-affiliates, and
a per share price of
U.S.$0.82, based on the closing sale price of our Common Shares on the
NASDAQ on March 11,
2010. As of the date hereof, we have not offered any securities pursuant to General Instruction
I.B.5 of Form F-3 during the prior twelve calendar month period that ends on and includes the date
hereof.
We may sell Securities to or through underwriters or dealers or directly to investors or
through agents. The Prospectus Supplement relating to a particular offering of Securities will
identify each person who may be deemed to be an underwriter with respect to such offering and will
set forth the terms of the offering of such Securities, including, to the extent applicable, the
offering price, the proceeds that we will receive, the underwriting discounts or commissions and
any other discounts or concessions to be allowed or reallowed to dealers. The managing underwriter
or underwriters with respect to Securities sold to or through underwriters will be named in the
related Prospectus Supplement. See Plan of Distribution.
You should rely only on the information contained in this Prospectus. We have not authorized
anyone to provide you with information different from that contained in this Prospectus. 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 our Securities.
Our registered office is located at 1405 du Parc-Technologique Blvd., Quebec City, Quebec,
Canada G1P 4P5.
TABLE OF CONTENTS
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CHANGES IN
LOAN AND CAPITAL STRUCTURE |
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DOCUMENTS INCORPORATED BY REFERENCE
The following documents have been filed with the various securities commissions or similar
securities regulatory authorities in Canada and are specifically incorporated by reference into,
and form an integral part of, this Prospectus:
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(a) |
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our annual report on Form 20-F for the financial year ended December 31, 2008
(filed in Canada with the Canadian securities regulatory authorities in lieu of an
annual information form), which was filed with the SEC on March 30, 2009 and which
includes our audited consolidated balance sheets as at December 31, 2008 and 2007 and
our audited consolidated statements of earnings (loss), changes in shareholders equity,
comprehensive income (loss) and cash flows for each of the years in the three-year
period ended December 31, 2008 and the financial statement schedules, together with the
auditors report thereon dated March 10, 2009, and our Managements Discussion and Analysis thereon included as Item 5.
Operating and Financial Review and Prospects in our annual report; |
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(b) |
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our unaudited interim consolidated financial statements as of and for the three-
and nine-month periods ended September 30, 2009 and 2008 and Managements Discussion and
Analysis thereon, which was included as Exhibit 99.1 to our report on Form 6-K furnished
to the SEC on November 12, 2009; |
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our management information circular dated March 10, 2009 in connection with our
annual meeting of shareholders held on May 6, 2009, which was included as Exhibit 99.1
to our report on Form 6-K furnished to the SEC on April 7, 2009; |
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our material change report dated March 16, 2009 with
respect to the entering into a development, commercialization and
licensing agreement with sanofi-aventis for the development,
registration and marketing of cetrorelix in benign prostatic
hyperplasia (BPH) for the U.S market, which was included as Exhibit
99.1 to our report on Form 6-K furnished to the SEC on March 17, 2009; |
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our material change report dated June 5, 2009 with respect to the presentation by our partner Keryx Biopharmaceuticals of positive Phase 2 data in the clinical activity of perifosine as a treatment for advanced metastatic colon
cancer and advanced renal cell carcinoma, which was included in our report
on Form 6-K furnished to the SEC on June 8, 2009; |
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our material change report dated June 23, 2009 with respect to our announcement that data
analysis and reporting of the results of the open-label safety study (study 041)
of our Phase 3 program in benign prostatic hyperplasia (BPH) with cetrorelix would
be brought forward from the scheduled fourth quarter into the third quarter of 2009,
and would follow the disclosure of results from the first double-blind placebo controlled
efficacy study (study 033), which was included in our report
on Form 6-K furnished to the SEC on June 23, 2009; |
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our material change report dated August 21, 2009 with respect to the
reporting of the Phase 3 results for our North American efficacy trial Z-033 and our
safety trial Z-041 in benign
prostatic hyperplasia (BPH) with cetrorelix, which was included as Exhibit
99.2 in our report on Form 6-K furnished to the SEC on August 21, 2009; |
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our material change report dated December 9, 2009 with respect to
the reporting of the Phase 3 results for our European efficacy trial Z-036 in
benign prostatic hyperplasia (BPH) with cetrorelix, which was included as Exhibit
99.1 in our report on Form 6-K furnished to the SEC on December 10, 2009; and |
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to the extent permitted by applicable securities law, any other documents which
we elect to incorporate by reference into this Prospectus. |
Any documents of the type referred to in the preceding paragraph, or similar material,
including any annual information form, annual report on Form 20-F, annual and interim financial
statements and related managements discussion and analysis, material change report (excluding any
confidential material change report, if any), business acquisition report and information circular
of Æterna Zentaris filed with the various securities commissions or similar securities regulatory
authorities in Canada or filed with or furnished to the SEC after the date of this Prospectus and
prior to the completion or withdrawal of any offering hereunder shall be deemed to be incorporated
by reference into this Prospectus.
Information has been incorporated by reference into this Prospectus from documents filed with
securities commissions or similar securities regulatory authorities in Canada. We will furnish
without charge to each person to whom a copy of this prospectus is delivered, upon written or oral
request, a copy of the information that has been incorporated into this prospectus by reference but
not delivered with the prospectus (except exhibits, unless they are specifically incorporated into
this prospectus by reference). Copies of the documents incorporated herein by reference may be
obtained on request without charge from the Corporate Secretary of Æterna Zentaris at 1405 du
Parc-Technologique Blvd., Quebec City, Quebec, Canada G1P 4P5, Tel. (418) 652-8525, or through the
Internet on the Canadian System for Electronic Document Analysis and Retrieval (SEDAR) which can
be accessed at www.sedar.com.
In addition to our continuous disclosure obligations under the securities laws of the
provinces of Canada, we are subject to the information requirements of the U.S. Securities Exchange
Act of 1934, as amended (the Exchange Act), and in accordance therewith we file with or furnish
to the SEC reports and other information. You may read and copy any document that we have filed
with the SEC at the SECs public reference room at Room 1580, 100 F Street N.E., Washington, D.C.,
20549. You may also obtain copies of the same documents from the public reference room of the SEC
by paying a fee. You should call the SEC at 1-800-SEC-0330 or access its website at
www.sec.gov for further information about the public reference rooms. The SECs EDGAR
Internet site also contains reports and other information about us and any public documents that we
file electronically with the SEC. The EDGAR site can be accessed at www.sec.gov.
Any statement contained in this Prospectus or in a document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or superseded, for the purposes of
this Prospectus, to the extent that a statement contained herein or in any other subsequently filed
document which also is or is deemed to be incorporated by reference herein modifies or supersedes
such statement. The modifying or superseding statement need not state that it has modified or
superseded a prior statement or include any other information set forth in the document that it
modifies or supersedes. The making of a modifying or superseding statement shall not be deemed an
admission for any purposes that the modified or superseded statement, when made, constituted a
misrepresentation, an untrue statement of a material fact or an omission to state a material fact
that is required to be stated or that is necessary to make a statement not misleading in light of
the circumstances in which it was made. Any statement so modified or superseded shall not
constitute a part of this Prospectus, except as so modified or superseded.
Upon a new annual information form or annual report on Form 20-F and the related audited
annual consolidated financial statements together with the auditors report thereon and
managements discussion and analysis related thereto being filed by us with the applicable
securities regulatory authorities during the currency of this Prospectus, the previous annual
information form or annual report on Form 20-F, the previous audited annual consolidated financial
statements and all interim financial statements, annual and quarterly managements discussion and
analyses, material change reports and business acquisition reports filed by us prior to the
commencement of our financial year in which the new annual information form or annual report on
Form 20-F was filed, no longer shall be deemed to be incorporated by reference into this Prospectus
for the purpose of future offers and sales of Securities hereunder.
One or more Prospectus Supplements containing the specific variable terms of an offering of
Securities and other information in relation to such Securities will be delivered to purchasers of
such Securities together with this Prospectus and shall be deemed to be incorporated by reference
into this Prospectus as of the date of such Prospectus Supplement solely for the purposes of the
offering of the Securities covered by any such Prospectus Supplement.
A Prospectus Supplement containing any additional or updated information that we elect to
include therein will be delivered with this Prospectus to purchasers of Securities who purchase
such Securities after the filing of this Prospectus and shall be deemed to be incorporated into
this Prospectus as of the date of such Prospectus Supplement.
- 2 -
In this Prospectus and in any Prospectus Supplement, unless otherwise indicated, references to
we, us, our, Æterna Zentaris or the Company are to Æterna Zentaris Inc., a Canadian
corporation, and its consolidated subsidiaries, unless it is clear that such terms refer only to
Æterna Zentaris Inc. excluding its subsidiaries. Unless otherwise indicated, all financial
information included in and incorporated by reference into this Prospectus and any Prospectus
Supplement is determined using Canadian GAAP.
CURRENCY AND EXCHANGE RATES
All references to Cdn$ are to Canadian dollars and all references to U.S.$ are to U.S.
dollars. The following table sets out the high and low exchange rates for one U.S. dollar expressed
in Canadian dollars, for the period indicated and, the average of such exchange rates, and the
exchange rate at the end of such period, in each case, based upon the noon rates as quoted by the
Bank of Canada:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Month |
|
Month |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ended |
|
ended |
Year ended December 31, |
|
|
|
February 28, |
|
January 31, |
|
|
|
|
|
|
|
|
|
|
2010 |
|
2010 |
|
2009 |
|
2008 |
|
2007 |
High |
|
|
1.0734 |
|
|
|
1.0657 |
|
|
|
1.3000 |
|
|
|
1.2969 |
|
|
|
1.1853 |
|
Low |
|
|
1.0420 |
|
|
|
1.0251 |
|
|
|
1.0292 |
|
|
|
0.9719 |
|
|
|
0.9170 |
|
Rate at end of period |
|
|
1.0526 |
|
|
|
1.0650 |
|
|
|
1.0466 |
|
|
|
1.2246 |
|
|
|
0.9881 |
|
Average rate per period |
|
|
1.0561 |
|
|
|
1.0440 |
|
|
|
1.1420 |
|
|
|
1.0660 |
|
|
|
1.0748 |
|
On
March 11, 2010, the exchange rate for one U.S. dollar expressed in Canadian
dollars based upon the noon rate of the Bank of Canada was Cdn$1.0265.
FORWARD-LOOKING STATEMENTS
This Prospectus and the documents incorporated herein by reference contain forward-looking
statements concerning the business, operations, financial performance and condition of Æterna
Zentaris. When used in this Prospectus, words such as may, will, should, could, expects, plans,
seeks, anticipates, intends, believes, estimates, predicts, potential or continue or the negative
of these terms and similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain such words. These forward-looking statements
are based on current expectations and are naturally subject to uncertainty and changes in
circumstances that may cause actual results to differ materially from those expressed or implied by
such forward-looking statements. Such statements, based as they are on the current expectations of
management, inherently involve numerous risks and uncertainties, known and unknown, many of which
are beyond our control. Such risks include but are not limited to:
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investments in biopharmaceutical companies are generally considered to be speculative; |
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we may never achieve or maintain operating profitability; |
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our clinical trials may not yield results which will enable us to obtain regulatory
approval for our products and we may suffer setbacks in any of our clinical trials; |
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we may not be able to successfully complete our clinical trials programs, or such
clinical trials could take longer to complete than we project; |
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the impact of the stringent ongoing government regulation to which our product
candidates are subject and future changes in such regulatory environment; |
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we may not be able to generate significant revenues if our products do not gain market
acceptance; |
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we may require significant additional financing, and we may not have access to
sufficient capital; |
- 3 -
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we may cease to continue operating as we do if we are unsuccessful in increasing our
revenues and/or raising additional funding; |
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failure to achieve our projected development goals in the time-frames we announce and
expect; |
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the impact of any failure on our part to obtain acceptable prices or adequate
reimbursement for our products on our ability to generate revenues; |
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competition in our targeted markets; |
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we may not obtain adequate protection for our products through our intellectual
property; |
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we may infringe the intellectual property rights of others; |
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we may incur liabilities from our involvement in any patent litigation; |
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we may not obtain trademark registrations in connection with our product candidates; |
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we may not be able to make adequate arrangements with third parties for the purpose of
commercializing our product candidates; |
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the failure to perform satisfactorily by third parties upon which we rely to conduct,
supervise and monitor our clinical trials; |
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the failure to perform satisfactorily by third parties upon which we rely to manufacture
and supply products; |
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our ability to retain or attract key personnel; |
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our strategic partners manufacturing capabilities may not be adequate to effectively
commercialize our product candidates; |
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risks related to product liability claims; |
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the impact of legislative actions, new accounting pronouncements and higher insurance
costs on our future financial position or results of operations; |
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fluctuations in currency exchange rates; |
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stock market volatility and the possibility that our Common Shares may be delisted from
the stock exchanges on which they currently trade; and |
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the fact that our largest shareholders have influence over our business and corporate
matters. |
More detailed information about these and other factors is included in this Prospectus under
the section entitled Risk Factors as well as in other documents incorporated by reference into
this Prospectus. Many of these factors are beyond our control. Future events may vary substantially
from what we currently foresee. You should not place undue reliance, if any, on such
forward-looking statements. Æterna Zentaris disavows and is under no obligation to update or alter
such forward-looking statements whether as a result of new information, future events or otherwise,
other than as required by applicable securities legislation.
ENFORCEABILITY OF CIVIL LIABILITIES
We are a corporation incorporated under and governed by the Canada Business Corporations Act.
Many of our officers and directors, and all of the experts named in this Prospectus, are residents
of Canada or elsewhere outside of the United States, and a
- 4 -
substantial portion of our assets and
the assets of such persons are located outside the United States. As a result, it may be difficult
for investors in the United States to effect service of process within the United States upon such
directors, officers and representatives of experts who are not residents of the United States or to enforce against them judgments of a
U.S. court predicated solely upon civil liability under U.S. federal securities laws or the
securities laws of any state within the United States. We have been advised by our legal counsel,
Ogilvy Renault LLP, that a judgment of a U.S. court predicated solely upon civil liability under
U.S. federal securities laws would probably be enforceable in Canada if the U.S. court in which the
judgment was obtained has a basis for jurisdiction in the matter that would be recognized by a
Canadian court for the same purposes. We have also been advised by Ogilvy Renault LLP, however,
that there is substantial doubt as to whether an action could be brought in Canada in the first
instance on the basis of liability predicated solely upon U.S. federal securities laws.
OUR BUSINESS
We are a late-stage drug development company specialized in oncology and endocrine therapy.
Æterna Zentaris Inc. was incorporated on September 12, 1990 under the laws of Canada. Our
registered office is located at 1405 du Parc-Technologique Blvd., Quebec City, Quebec, Canada G1P
4P5, our telephone number is (418) 652-8525 and our website is www.aezsinc.com. None of the
documents or information found on our website shall be deemed to be included in or incorporated
into this Prospectus, unless such document is specifically incorporated herein by reference and
enumerated as such under Documents Incorporated by Reference.
We currently have three wholly-owned direct and indirect subsidiaries, Æterna Zentaris GmbH
(AEZS Germany) based in Frankfurt, Germany, Zentaris IVF GmbH, a direct wholly-owned subsidiary
of AEZS Germany, based in Frankfurt, Germany and Æterna Zentaris, Inc., based in Warren, New Jersey
in the United States. AEZS Germany is our principal operating subsidiary.
Our Common Shares are currently listed for trading on the TSX under the trading symbol AEZ
and on the NASDAQ under the trading symbol AEZS.
Our pipeline encompasses compounds at all stages of development, from drug discovery through
marketed products. The highest priorities in oncology are our Phase 3 program with perifosine in
multiple myeloma and our Phase 2 program in multiple cancers, including metastatic colon cancer, as
well as our Phase 2 program with AEZS-108 in advanced endometrial and advanced ovarian cancer
combined with potential developments in other cancer indications. In endocrinology, our lead
program is the reactivation of a Phase 3 trial with AEZS-130 as a growth hormone (GH) stimulation
test for the diagnosis of GH deficiency in adults (AGHD).
- 5 -
The following table summarizes the development status of our principal products and product
candidates.
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Drug |
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Discovery |
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Preclinical Trials |
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Phase 1 |
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Phase 2 |
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Phase 3 |
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Marketed |
120,000 compound
library
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AEZS-120
Prostate cancer
vaccine
(Oncology)
AEZS-129
Erk & PI3K inhibitor
(Oncology)
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AEZS-112
(Oncology)
AEZS-130
Therapeutic in
tumor cachexia
(Endocrinology)
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Perifosine
§ Metastatic colon
cancer
§ Kidney cancer
and others
AEZS-108
§ Ovarian cancer
§ Endometrial
cancer
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Perifosine
Multiple myeloma
Solorel (AEZS-130)
Diagnostic in adult
growth hormone
deficiency
(Endocrinology)
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CetrotideÒ
(In vitro fertilization)
(Endocrinology) |
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AEZS-127
ErPC (Oncology)
AEZS-123
Ghrelin receptor
antagonist
(Endocrinology) |
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AEZS-115
Non-peptide LHRH
antagonists
(Endometriosis &
urology) |
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Partners
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Perifosine:
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Perifosine:
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CetrotideÒ: |
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Keryx
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Keryx
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Merck Serono |
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North America & Mexico
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North America &
Mexico
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World ex-Japan |
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Handok
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Handok
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Nippon Kayaku / Shionogi |
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Korea
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Korea
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Japan |
Our Business Strategy
Our primary business strategy is to
advance, with the collaboration of our strategic partners, our product development pipeline with a focus on
our flagship product candidates in oncology and endocrinology. In addition, we also continue to
advance certain other clinical and pre-clinical programs as described below. Our vision is to
become a fully-integrated specialty biopharmaceutical company.
Oncology
Our highest oncology priorities are our perifosine Phase 3 program in multiple myeloma and
Phase 2 program in multiple cancers including metastatic colon cancer, as well as our Phase 2
program with AEZS-108 in advanced endometrial and advanced ovarian cancer combined with potential
development in other cancer indications.
Perifosine
Perifosine is an orally active PI3K/Akt pathway inhibitor in a Phase 3 registration trial in
multiple myeloma conducted by our North American partner Keryx for the territories of North America
and Mexico under a Special Protocol Assessment reached with the Food and Drug Administration
(FDA), which has also granted perifosine Orphan Drug and Fast Track designations. Perifosine is
also in current multiple Phase 2 clinical studies, including metastatic colon cancer, renal cell
carcinoma and various other cancers.
Furthermore, our partner Keryx announced on February 3, 2010 that it has reached another
special protocol assessment in refractory metastatic colon cancer with the FDA and is planning the
initiation of a registration Phase 3 trial in this indication.
- 6 -
AEZS-108
AEZS-108 represents a new targeting concept in oncology leading to personalized medicine using
a cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier
and doxorubicin. The design of AEZS-108 allows for the specific binding and selective uptake of the
cytotoxic conjugate by LHRH-receptor-positive tumors. Phase 2 trials in advanced endometrial cancer
and advanced ovarian cancer have met their predefined primary efficacy endpoints.
Endocrinology
In endocrinology, aside from CetrotideÒ, we intend to further advance the
development of our lead program by the reactivation and further advancement of a Phase 3 trial with
Solorel (AEZS-130) as a GH stimulation test for the diagnosis of AGHD.
AEZS-130 (macimorelin)
AEZS-130 (macimorelin), a growth hormone secretagogue (GHS), is a novel synthetic small
molecule acting as a ghrelin mimetic that is orally active and stimulates the secretion of GH. A
pivotal Phase 3 trial was initiated in the United States to investigate its safety and efficacy as
a GH stimulation test for the diagnosis of AGHD for which Orphan Drug status has been granted by
the FDA. In addition to the diagnostic indication, we believe that AEZS-130, based on the results
of Phase 1 studies, has potential applications for the treatment of cachexia, a condition
frequently associated with severe chronic diseases such as cancer, chronic obstructive pulmonary
disease and AIDS.
Clinical and Preclinical Programs
Additionally, we are advancing in Phase 1, AEZS-112, an oral anticancer agent which involves
three mechanisms of action, tubulin and topoisomeras II and angiogenesic inhibition, as well as
several preclinical programs with targeted potential development candidates. Among the targets for
which we expect to propose clinical development candidates in the coming years are: AEZS-120
(prostate cancer vaccine), AEZS-127 (erucylphosphocholine derivatives), AEZS-129 (Erk and PI3K
inhibitor), AEZS-115 (non-peptide LHRH antagonists) and AEZS-123 (ghrelin receptor antagonist).
We also continue to perform targeted drug discovery activities from which we are able to
derive pre-clinical candidates. This drug discovery includes high throughput screening systems and
a library of more than 120,000 compounds.
We are currently in a stage in which some of our products and product candidates are being
further developed or marketed jointly with strategic partners. We expect we will continue to seek
strategic partnerships in the future as we move to realize our vision of becoming a
fully-integrated specialty biopharmaceutical company.
- 7 -
RISK FACTORS
The purchase of Securities offered under this Prospectus involves risks which prospective
purchasers should take into consideration when making a decision to purchase such Securities.
Investors should carefully consider the risks described below, together with all of the other
information included in this Prospectus and the documents incorporated by reference into this
Prospectus, before making an investment decision. Certain of these risk factors have been disclosed
in our annual report on Form 20-F for the financial year ended December 31, 2008 (filed in Canada
with the Canadian securities regulatory authorities in lieu of an annual information form) under
the heading Risks Factors and in our managements discussion and analysis for the period ended
September 30, 2009 under the heading Risks Factors and Uncertainties, which documents are
incorporated by reference into this Prospectus. This discussion of risk factors will be updated
from time to time in our subsequent filings with the Canadian securities regulatory authorities,
including in subsequent annual and quarterly managements discussion and analysis and annual
information forms. If any of the following risks actually occurs or materializes, our business,
financial condition or results of operations could be adversely affected, even materially adversely
affected. In such an event, the trading price of our Securities could decline and you may lose part
or all of your investment. Any reference in this section to our products includes a reference to
our product candidates and future products we may develop.
Risks Related to Us and Our Business
Investments in biopharmaceutical companies are generally considered to be speculative.
The prospects for companies operating in the biopharmaceutical industry may generally be
considered to be uncertain, given the very nature of the industry and, accordingly, investments in
biopharmaceutical companies should be considered to be speculative.
We have a history of operating losses and we may never achieve or maintain operating profitability.
Our product candidates remain at the development stage and we have incurred substantial
expenses in our efforts to develop products. Consequently, we have incurred recurrent operating
losses and, as disclosed in our unaudited interim consolidated financial statements as of and for
the three- and nine-month periods ended September 30, 2009 and 2008, we had an accumulated deficit
of U.S.$139.6 million as of September 30, 2009. Our operating losses have adversely impacted, and
will continue to adversely impact, our working capital, total assets and shareholders equity. We
do not expect to reach operating profitability in the immediate future, and our expenses are likely
to increase as we continue to expand our research and development (R&D) and clinical study
programs and our sales and marketing activities and seek regulatory approval for our product
candidates. Even if we succeed in developing new commercial products, we expect to incur additional
operating losses for at least the next several years. If we do not ultimately generate sufficient
revenue from commercialized products and achieve or maintain operating profitability, an investment
in our Securities could result in a significant or total loss.
Our clinical trials may not yield results which will enable us to obtain regulatory approval for
our products, and a setback in any of our clinical trials would likely cause a drop in the price of
our Securities.
We will only receive regulatory approval for a product candidate if we can demonstrate in
carefully designed and conducted clinical trials that the product candidate is both safe and
effective. We do not know whether our pending or any future clinical trials will demonstrate
sufficient safety and efficacy to obtain the requisite regulatory approvals or will result in
marketable products. Unfavorable data from those studies could result in the withdrawal of
marketing approval for approved products or an extension of the review period for developmental
products. Clinical trials are inherently lengthy, complex, expensive and uncertain processes and
have a high risk of failure. It typically takes many years to complete testing, and failure can
occur at any stage of testing. Results attained in preclinical testing and early clinical studies,
or trials, may not be indicative of results that are obtained in later studies.
None of our product candidates has to date received regulatory approval for its intended
commercial sale. We cannot market a pharmaceutical product in any jurisdiction until it has
completed rigorous preclinical testing and clinical trials and passed such jurisdictions extensive
regulatory approval process. In general, significant research and development and clinical studies
are required to demonstrate the safety and efficacy of our product candidates before we can submit
regulatory applications. Pre-clinical testing and clinical development are long, expensive and
uncertain processes. Preparing, submitting and advancing applications for regulatory approval is
complex, expensive and time-consuming and entails significant uncertainty. Data obtained from
pre-clinical and clinical tests can be interpreted in different ways, which could delay, limit or
prevent regulatory approval. It may take us many years to complete the testing of our product
candidates and failure can occur at any stage of this process. In addition, we have limited
experience in conducting and managing the clinical trials necessary to obtain regulatory approval
in the United States, in Canada and
- 8 -
abroad and, accordingly, may encounter unforeseen problems and delays in the approval process.
Though we may engage a clinical research organization with experience in conducting regulatory
trials, errors in the conduct, monitoring and/or auditing could invalidate the results from a
regulatory perspective. Even if a product candidate is approved by the FDA, the Canadian
Therapeutic Products Directorate or any other regulatory authority, we may not obtain approval for
an indication whose market is large enough to recoup our investment in that product candidate. In
addition, there can be no assurance that we will ever obtain all or any required regulatory
approvals for any of our product candidates.
We are currently developing our product candidates based on R&D activities, preclinical
testing and clinical trials conducted to date, and we may not be successful in developing or
introducing to the market these or any other new products or technology. If we fail to develop and
deploy new products successfully and on a timely basis, we may become non-competitive and unable to
recoup the R&D and other expenses we incur to develop and test new products.
Interim results of preclinical or clinical studies do not necessarily predict their final
results, and acceptable results in early studies might not be obtained in later studies. Safety
signals detected during clinical studies and pre-clinical animal studies may require us to do
additional studies, which could delay the development of the drug or lead to a decision to
discontinue development of the drug. Product candidates in the later stages of clinical development
may fail to show the desired safety and efficacy traits despite positive results in initial
clinical testing. Results from earlier studies may not be indicative of results from future
clinical trials and the risk remains that a pivotal program may generate efficacy data that will be
insufficient for the approval of the drug, or may raise safety concerns that may prevent approval
of the drug. Interpretation of the prior pre-clinical and clinical safety and efficacy data of our
product candidates may be flawed and there can be no assurance that safety and/or efficacy concerns
from the prior data were overlooked or misinterpreted, which in subsequent, larger studies appear
and prevent approval of such product candidates.
Furthermore, we may suffer significant setbacks in advanced clinical trials, even after
promising results in earlier studies. Based on results at any stage of clinical trials, we may
decide to repeat or redesign a trial or discontinue development of one or more of our product
candidates. Further, actual results may vary once the final and quality-controlled verification of
data and analyses has been completed. If we fail to adequately demonstrate the safety and efficacy
of our products under development, we will not be able to obtain the required regulatory approvals
to commercialize our product candidates.
Clinical trials are subject to continuing oversight by governmental regulatory authorities and
institutional review boards and:
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must meet the requirements of these authorities; |
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must meet requirements for informed consent; and |
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must meet requirements for good clinical practices. |
We may not be able to comply with these requirements in respect of one or more of our product
candidates.
In addition, we rely on third parties, including Contract Research Organizations (CROs) and
outside consultants, to assist us in managing and monitoring clinical trials. Our reliance on these
third parties may result in delays in completing, or in failing to complete, these trials if one or
more third parties fails to perform with the speed and level of competence we expect.
A failure in the development of any one of our programs or product candidates could have a
negative impact on the development of the others. Setbacks in any phase of the clinical development
of our product candidates would have an adverse financial impact (including with respect to any
agreements and partnerships that may exist between us and other entities), could jeopardize
regulatory approval and would likely cause a drop in the price of our Securities.
If we are unable to successfully complete our clinical trial programs, or if such clinical
trials take longer to complete than we project, our ability to execute our current business
strategy will be adversely affected.
Whether or not and how quickly we complete clinical trials is dependent in part upon the rate
at which we are able to engage clinical trial sites and, thereafter, the rate of enrollment of
patients, and the rate we collect, clean, lock and analyze the clinical trial database. Patient
enrollment is a function of many factors, including the design of the protocol, the size of the
patient population, the proximity of patients to and availability of clinical sites, the
eligibility criteria for the study, the perceived risks and benefits of the drug under study and of
the control drug, if any, the efforts to facilitate timely enrollment in clinical trials, the
patient referral practices
- 9 -
of physicians, the existence of competitive clinical trials, and whether existing or new drugs
are approved for the indication we are studying. Certain clinical trials are designed to continue
until a pre-determined number of events have occurred to the patients enrolled. Trials such as this
are subject to delays stemming from patient withdrawal and from lower than expected event rates and
may also incur increased costs if enrollment is increased in order to achieve the desired number of
events. If we experience delays in identifying and contracting with sites and/or in patient
enrollment in our clinical trial programs, we may incur additional costs and delays in our
development programs, and may not be able to complete our clinical trials on a cost-effective or
timely basis. In addition, conducting multi-national studies adds another level of complexity and
risk as we are subject to events affecting countries outside Canada. Moreover, negative or
inconclusive results from the clinical trials we conduct or adverse medical events could cause us
to have to repeat or terminate the clinical trials. Accordingly, we may not be able to complete the
clinical trials within an acceptable time frame, if at all. If we or any third party have
difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we
may need to delay or terminate ongoing clinical trials.
Additionally, we have never filed a
new drug application (NDA), or similar application for
approval in the United States or in any country for our current
product candidates, which may result in a delay in, or the rejection
of, our filing of an NDA or similar application. During the drug development process, regulatory
agencies will typically ask questions of drug sponsors. While we endeavor to answer all such
questions in a timely fashion, or in the NDA filing, some questions may not be answered by the time
we file our NDA. Unless the FDA waives the requirement to answer any such unanswered questions,
submission of an NDA may be delayed or rejected.
Even if we obtain regulatory approvals for our product candidates, we will be subject to stringent
ongoing government regulation.
Even if regulatory authorities approve any of our product candidates, the manufacture,
marketing and sale of such products will be subject to strict and ongoing regulation. Compliance
with such regulation will be expensive and consume substantial financial and management resources.
For example, an approval for a product may be conditioned on our agreement to conduct costly
post-marketing follow-up studies to monitor the safety or efficacy of the products. In addition, as
a clinical experience with a drug expands after approval because the drug is used by a greater
number and more diverse group of patients than during clinical trials, side effects or other
problems may be observed after approval that were not observed or anticipated during pre-approval
clinical trials. In such a case, a regulatory authority could restrict the indications for which
the product may be sold or revoke the products regulatory approval.
We and our contract manufacturers will be required to comply with applicable current Good
Manufacturing Practice (cGMP) regulations for the manufacture of our products. These regulations
include requirements relating to quality assurance, as well as the corresponding maintenance of
rigorous records and documentation. Manufacturing facilities must be approved before we can use
them in the commercial manufacturing of our products and are subject to subsequent periodic
inspection by regulatory authorities. In addition, material changes in the methods of manufacturing
or changes in the suppliers of raw materials are subject to further regulatory review and approval.
If we, or any future marketing collaborators or contract manufacturers, fail to comply with
applicable regulatory requirements, we may be subject to sanctions including fines, product recalls
or seizures and related publicity requirements, injunctions, total or partial suspension of
production, civil penalties, suspension or withdrawals of previously granted regulatory approvals,
warning or untitled letters, refusal to approve pending applications for marketing approval of new
products or of supplements to approved applications, import or export bans or restrictions, and
criminal prosecution and penalties. Any of these penalties could delay or prevent the promotion,
marketing or sale of our products.
If our products do not gain market acceptance, we may be unable to generate significant revenues.
Even if our products are approved for commercialization, they may not be successful in the
marketplace. Market acceptance of any of our products will depend on a number of factors including,
but not limited to:
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demonstration of clinical efficacy and safety; |
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the prevalence and severity of any adverse side effects; |
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limitations or warnings contained in the products approved labeling; |
- 10 -
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availability of alternative treatments for the indications we target; |
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the advantages and disadvantages of our products relative to current or alternative
treatments; |
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the availability of acceptable pricing and adequate third-party reimbursement; and |
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the effectiveness of marketing and distribution methods for the products. |
If our products do not gain market acceptance among physicians, patients, healthcare payers
and others in the medical community, which may not accept or utilize our products, our ability to
generate significant revenues from our products would be limited and our financial conditions will
be materially adversely affected. In addition, if we fail to further penetrate our core markets and
existing geographic markets or successfully expand our business into new markets, the growth in
sales of our products, along with our operating results, could be negatively impacted.
Our ability to further penetrate our core markets and existing geographic markets in which we
compete or to successfully expand our business into additional countries in Europe, Asia or
elsewhere is subject to numerous factors, many of which are beyond our control. Our products, if
successfully developed, may compete with a number of drugs and therapies currently manufactured and
marketed by major pharmaceutical and other biotechnology companies. Our products may also compete
with new products currently under development by others or with products which may be less
expensive than our products. We cannot assure you that our efforts to increase market penetration
in our core markets and existing geographic markets will be successful. Our failure to do so could
have an adverse effect on our operating results and would likely cause a drop in the price of our
Securities.
We may require significant additional financing, and we may not have access to sufficient
capital.
We may require additional capital to pursue planned clinical trials, regulatory approvals, as
well as further R&D and marketing efforts for our product candidates and potential products. Except
as expressly described in this Prospectus and the documents incorporated by reference herein, we do
not anticipate generating significant revenues from operations in the near future and we currently
have no committed sources of capital.
We may attempt to raise additional funds through public or private financings, collaborations
with other pharmaceutical companies or financing from other sources. Additional funding may not be
available on terms which are acceptable to us. If adequate funding is not available to us on
reasonable terms, we may need to delay, reduce or eliminate one or more of our product development
programs or obtain funds on terms less favorable than we would otherwise accept. To the extent that
additional capital is raised through the sale of equity securities or securities convertible into
or exchangeable for equity securities, the issuance of those securities could result in dilution to
our shareholders. Moreover, the incurrence of debt financing could result in a substantial portion
of our future operating cash flow, if any, being dedicated to the payment of principal and interest
on such indebtedness and could impose restrictions on our operations. This could render us more
vulnerable to competitive pressures and economic downturns.
We anticipate that our existing working capital, including the proceeds from any sale of
Securities hereunder and anticipated revenues, will be sufficient to fund our development programs,
clinical trials and other operating expenses for the near future. However, our future capital
requirements are substantial and may increase beyond our current expectations depending on many
factors including:
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the duration and results of our clinical trials for our various product candidates
going forward; |
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unexpected delays or developments in seeking regulatory approvals; |
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the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent
claims; |
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other unexpected developments encountered in implementing our business development and
commercialization strategies; |
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the outcome of litigation, if any; and |
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further arrangements, if any, with collaborators. |
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In addition, the ongoing recessionary global market and economic conditions as well as certain
continuing difficulties in the credit and capital markets may make it even more difficult for us to
raise additional financing in the future.
If we are unsuccessful in increasing our revenues and/or raising additional funding, we may
possibly cease to continue operating as we currently do.
Although our unaudited interim consolidated financial statements as of and for the three- and
nine-month periods ended September 30, 2009 and 2008 have been prepared on a going concern basis,
which contemplates the realization of assets and liquidation of liabilities during the normal
course of operations, our ability to continue as a going concern is dependent on the successful
execution of our business plan, which will require an increase in revenue and/or additional funding
to be provided by potential investors as well as non-traditional sources of financing. Although we
stated in our unaudited interim consolidated financial statements as of and for the three- and
nine-month periods ended September 30, 2009 and 2008 that management believed that the Company had,
as at September 30, 2009, sufficient financial resources to fund planned expenditures and other
working capital needs for at least, but not limited to, the 12-month period following such date,
there can be no assurance that management will be able to reiterate such belief in our future
financial statements.
We have had sustained losses, accumulated deficits and negative cash flows from operations
since our inception. We expect that this will continue throughout 2010.
Additional funding may be in the form of debt or equity or a hybrid instrument depending on
the needs of the investor. Given the prevailing global economic and credit market conditions, we
may not be able to raise additional cash resources through these traditional sources of financing.
Although we are also pursuing non-traditional sources of financing, the global credit market crisis
has also adversely affected the ability of potential parties to pursue such transactions. We do not
believe that the ability to access capital markets or these adverse conditions are likely to
improve significantly in the near future. Accordingly, as a result of the foregoing, we continue to
review traditional sources of financing, such as private and public debt or equity financing
alternatives, as well as other alternatives to enhance shareholder value, including, but not
limited to, non-traditional sources of financing, such as alliances with strategic partners, the
sale of assets or licensing of our technology or intellectual property, a combination of operating
and related initiatives or a substantial reorganization of our business. If we do not raise
additional capital, we do not expect our operations to generate sufficient cash flow to
fund our obligations as they come due.
There can be no assurances that we will achieve profitability or positive cash flows or be
able to obtain additional funding or that, if obtained, they will be sufficient, or whether any
other initiatives will be successful, such that we may continue as a going concern. There are
material uncertainties related to certain adverse conditions and events that could cast significant
doubt on our ability to remain a going concern.
We may not achieve our projected development goals in the time-frames we announce and expect.
We set goals and make public statements regarding the timing of the accomplishment of
objectives material to our success, such as the commencement, enrollment and completion of clinical
trials, anticipated regulatory submission and approval dates and time of product launch. The actual
timing of these events can vary dramatically due to factors such as delays or failures in our
clinical trials, the uncertainties inherent in the regulatory approval process and delays in
achieving manufacturing or marketing arrangements sufficient to commercialize our products. There
can be no assurance that our clinical trials will be completed, that we will make regulatory
submissions or receive regulatory approvals as planned or that we will be able to adhere to our
current schedule for the launch of any of our products. If we fail to achieve one or more of these
milestones as planned, the price of our Securities would likely decline.
If we fail to obtain acceptable prices or adequate reimbursement for our products, our ability to
generate revenues will be diminished.
The ability for us and/or our partners to successfully commercialize our products will depend
significantly on our ability to obtain acceptable prices and the availability of reimbursement to
the patient from third-party payers, such as governmental and private insurance plans. These
third-party payers frequently require companies to provide predetermined discounts from list
prices, and they are increasingly challenging the prices charged for pharmaceuticals and other
medical products. Our products may not be considered
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cost-effective, and reimbursement to the patient may not be available or sufficient to allow
us or our partners to sell our products on a competitive basis. It may not be possible to negotiate
favorable reimbursement rates for our products.
In addition, the continuing efforts of third-party payers to contain or reduce the costs of
healthcare through various means may limit our commercial opportunity and reduce any associated
revenue and profits. We expect proposals to implement similar government control to continue. In
addition, increasing emphasis on managed care will continue to put pressure on the pricing of
pharmaceutical and biopharmaceutical products. Cost control initiatives could decrease the price
that we or any current or potential collaborators could receive for any of our products and could
adversely affect our profitability. In addition, in the United States, in Canada and in many other
countries, pricing and/or profitability of some or all prescription pharmaceuticals and
biopharmaceuticals are subject to government control.
If we fail to obtain acceptable prices or an adequate level of reimbursement for our products,
the sales of our products would be adversely affected or there may be no commercially viable market
for our products.
Competition in our targeted markets is intense, and development by other companies could render our
products or technologies non-competitive.
The biomedical field is highly competitive. New products developed by other companies in the
industry could render our products or technologies non-competitive. Competitors are developing and
testing products and technologies that would compete with the products that we are developing. Some
of these products may be more effective or have an entirely different approach or means of
accomplishing the desired effect than our products. We expect competition from biopharmaceutical
and pharmaceutical companies and academic research institutions to increase over time. Many of our
competitors and potential competitors have substantially greater product development capabilities
and financial, scientific, marketing and human resources than we do. Our competitors may succeed in
developing products earlier and in obtaining regulatory approvals and patent protection for such
products more rapidly than we can or at a lower price.
We may not obtain adequate protection for our products through our intellectual property.
We rely heavily on our proprietary information in developing and manufacturing our product
candidates. Our success depends, in large part, on our ability to protect our competitive position
through patents, trade secrets, trademarks and other intellectual property rights. The patent
positions of pharmaceutical and biopharmaceutical firms, including Æterna Zentaris, are uncertain
and involve complex questions of law and fact for which important legal issues remain unresolved.
Applications for patents and trademarks in Canada, the United States and in other foreign
territories have been filed and are being actively pursued by us. Pending patent applications may
not result in the issuance of patents and we may not be able to obtain additional issued patents
relating to our technology or products. Even if issued, patents to us or our licensors may be
challenged, narrowed, invalidated, held to be unenforceable or circumvented, which could limit our
ability to stop competitors from marketing similar products or limit the length of term of patent
protection we may have for our products. Changes in either patent laws or in interpretations of
patent laws in the United States and other countries may diminish the value of our intellectual
property or narrow the scope of our patent protection. The patents issued or to be issued to us may
not provide us with any competitive advantage or protect us against competitors with similar
technology. In addition, it is possible that third parties with products that are very similar to
ours will circumvent our patents by means of alternate designs or processes. We may have to rely on
method of use and new formulation protection for our compounds in development, and any resulting
products, which may not confer the same protection as claims to compounds per se.
In addition, our patents may be challenged by third parties in patent litigation, which is
becoming widespread in the biopharmaceutical industry. There may be prior art of which we are not
aware that may affect the validity or enforceability of a patent claim. There also may be prior art
of which we are aware, but which we do not believe affects the validity or enforceability of a
claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a
claim. No assurance can be given that our patents would, if challenged, be held by a court to be
valid or enforceable or that a competitors technology or product would be found by a court to
infringe our patents. Our granted patents could also be challenged and revoked in opposition or
nullity proceedings in certain countries outside the United States. In addition, we may be required
to disclaim part of the term of certain patents.
Patent applications relating to or affecting our business have been filed by a number of
pharmaceutical and biopharmaceutical companies and academic institutions. A number of the
technologies in these applications or patents may conflict with our technologies, patents or patent
applications, and any such conflict could reduce the scope of patent protection which we could
otherwise obtain. Because patent applications in the United States and many other jurisdictions are
typically not published until eighteen months after
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their first effective filing date, or in some cases not at all, and because publications of
discoveries in the scientific literature often lag behind actual discoveries, neither we nor our
licensors can be certain that we or they were the first to make the inventions claimed in our or
their issued patents or pending patent applications, or that we or they were the first to file for
protection of the inventions set forth in these patent applications. If a third party has also
filed a patent application in the United States covering our product candidates or a similar
invention, we may have to participate in an adversarial proceeding, known as an interference,
declared by the United States Patent and Trademark Office to determine priority of invention in the
United States. The costs of these proceedings could be substantial and it is possible that our
efforts could be unsuccessful, resulting in a loss of our U.S. patent position.
In addition to patents, we rely on trade secrets and proprietary know-how to protect our
intellectual property. If we are unable to protect the confidentiality of our proprietary
information and know-how, the value of our technology and products could be adversely affected. We
seek to protect our unpatented proprietary information in part by requiring our employees,
consultants, outside scientific collaborators and sponsored researchers and other advisors to enter
into confidentiality agreements. These agreements provide that all confidential information
developed or made known to the individual during the course of the individuals relationship with
us is to be kept confidential and not disclosed to third parties except in specific circumstances.
In the case of our employees, the agreements provide that all of the technology which is conceived
by the individual during the course of employment is our exclusive property. These agreements may
not provide meaningful protection or adequate remedies in the event of unauthorized use or
disclosure of our proprietary information. In addition, it is possible that third parties could
independently develop proprietary information and techniques substantially similar to ours or
otherwise gain access to our trade secrets. If we are unable to protect the confidentiality of our
proprietary information and know-how, competitors may be able to use this information to develop
products that compete with our products and technologies, which could adversely impact our
business.
We currently have the right to use certain technology under license agreements with third
parties. Our failure to comply with the requirements of material license agreements could result in
the termination of such agreements, which could cause us to terminate the related development
program and cause a complete loss of our investment in that program.
As a result of the foregoing factors, we may not be able to rely on our intellectual property
to protect our products in the marketplace.
We may infringe the intellectual property rights of others.
Our commercial success depends significantly on our ability to operate without infringing the
patents and other intellectual property rights of third parties. There could be issued patents of
which we are not aware that our products or methods may be found to infringe, or patents of which
we are aware and believe we do not infringe but which we may ultimately be found to infringe.
Moreover, patent applications and their underlying discoveries are in some cases maintained in
secrecy until patents are issued. Because patents can take many years to issue, there may be
currently pending applications of which we are unaware that may later result in issued patents that
our products or methods are found to infringe. Moreover, there may be published pending
applications that do not currently include a claim covering our products or methods but which
nonetheless provide support for a later drafted claim that, if issued, our products or methods
could be found to infringe.
If we infringe or are alleged to infringe intellectual property rights of third parties, it
will adversely affect our business. Our research, development and commercialization activities, as
well as any product candidates or products resulting from these activities, may infringe or be
accused of infringing one or more claims of an issued patent or may fall within the scope of one or
more claims in a published patent application that may subsequently issue and to which we do not
hold a license or other rights. Third parties may own or control these patents or patent
applications in the United States and abroad. These third parties could bring claims against us or
our collaborators that would cause us to incur substantial expenses and, if successful against us,
could cause us to pay substantial damages. Further, if a patent infringement suit were brought
against us or our collaborators, we or they could be forced to stop or delay research, development,
manufacturing or sales of the product or product candidate that is the subject of the suit.
The biopharmaceutical industry has produced a proliferation of patents, and it is not always
clear to industry participants, including us, which patents cover various types of products. The
coverage of patents is subject to interpretation by the courts, and the interpretation is not
always uniform. In the event of infringement or violation of another partys patent or other
intellectual property rights, we may not be able to enter into licensing arrangements or make other
arrangements at a reasonable cost. Any inability to secure licenses or alternative technology could
result in delays in the introduction of our products or lead to prohibition of the manufacture or
sale of products by us or our partners and collaborators.
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Patent litigation is costly and time consuming and may subject us to liabilities.
Our involvement in any patent litigation, interference, opposition or other administrative
proceedings will likely cause us to incur substantial expenses, and the efforts of our technical
and management personnel will be significantly diverted. In addition, an adverse determination in
litigation could subject us to significant liabilities.
We may not obtain trademark registrations.
We have filed applications for trademark registrations in connection with our product
candidates in various jurisdictions, including the United States. We intend to file further
applications for other possible trademarks for our product candidates. No assurance can be given
that any of our trademark applications will be registered in the United States or elsewhere, or
that the use of any registered or unregistered trademarks will confer a competitive advantage in
the marketplace. Furthermore, even if we are successful in our trademark registrations, the FDA and
regulatory authorities in other countries have their own process for drug nomenclature and their
own views concerning appropriate proprietary names. The FDA and other regulatory authorities also
have the power, even after granting market approval, to request a company to reconsider the name
for a product because of evidence of confusion in the marketplace. No assurance can be given that
the FDA or any other regulatory authority will approve of any of our trademarks or will not request
reconsideration of one of our trademarks at some time in the future. The loss, abandonment, or
cancellation of any of our trademarks or trademark applications could negatively affect the success
of the product candidates to which they relate.
Our revenues and expenses may fluctuate significantly, and any failure to meet financial
expectations may disappoint securities analysts or investors and result in a decline in the price
of our Securities.
We have a history of operating losses. Our revenues and expenses have fluctuated in the past
and are likely to do so in the future. These fluctuations could cause our share price to decline.
Some of the factors that could cause our revenues and expenses to fluctuate include but are not
limited to:
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the inability to complete product development in a timely manner that results in a
failure or delay in receiving the required regulatory approvals to commercialize our
product candidates; |
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the timing of regulatory submissions and approvals; |
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the timing and willingness of any current or future collaborators to invest the
resources necessary to commercialize our product candidates; |
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the revenue available from royalties derived from our strategic partners; |
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licensing fees revenues; |
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tax credits and grants (R&D); |
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the outcome of litigation, if any; |
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changes in foreign currency fluctuations; |
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the timing of achievement and the receipt of milestone payments from current or future
collaborators; and |
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failure to enter into new or the expiration or termination of current agreements with
collaborators. |
Due to fluctuations in our revenues and expenses, we believe that period-to-period comparisons
of our results of operations are not necessarily indicative of our future performance. It is
possible that in some future quarter or quarters, our revenues and expenses will be above or below
the expectations of securities analysts or investors. In this case, the price of our Securities
could fluctuate significantly or decline.
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We may invest or spend the proceeds of any offering of Securities under this Prospectus in ways
with which investors may not agree and in ways that may not earn a profit.
Our management team will have broad discretion concerning the use of the proceeds of any
offering of Securities under this Prospectus as well as the timing of their expenditure. As a
result, investors will be relying on the judgment of management for the application of the proceeds
of any offering of Securities under this Prospectus. We intend to use the proceeds from any
offering primarily for general corporate purposes, which may include, but are not limited to, our
current clinical development programs. Investors may not agree with the ways we decide to use these
proceeds, and our use of the proceeds may not yield any results or profits.
We will not be able to successfully commercialize our product candidates if we are unable to make
adequate arrangements with third parties for such purposes.
We currently have a lean sales and marketing staff. In order to commercialize our product
candidates successfully, we need to make arrangements with third parties to perform some or all of
these services in certain territories.
We contract with third parties for the sales and marketing of our products. Our revenues will
depend upon the efforts of these third parties, whose efforts may not be successful. If we fail to
establish successful marketing and sales capabilities or to make arrangements with third parties
for such purposes, our business, financial condition and results of operations will be materially
adversely affected.
If we had to resort to developing a sales force internally, the cost of establishing and
maintaining a sales force would be substantial and may exceed its cost effectiveness. In addition,
in marketing our products, we would likely compete with many companies that currently have
extensive and well-funded marketing and sales operations. Despite our marketing and sales efforts,
we may be unable to compete successfully against these companies.
We are currently dependent on strategic partners and may enter into future collaborations for
the research, development and commercialization of our product candidates. Our arrangements with
these strategic partners may not provide us with the benefits we expect and may expose us to a
number of risks.
We are dependent on, and rely upon, strategic partners to perform various functions related to
our business, including, but not limited to, the research, development and commercialization of
some of our product candidates. Our reliance on these relationships poses a number of risks.
We may not realize the contemplated benefits of such agreements nor can we be certain that any
of these parties will fulfill their obligations in a manner which maximizes our revenue. These
arrangements may also require us to transfer certain material rights or issue our equity, voting or
other securities to corporate partners, licensees and others. Any license or sublicense of our
commercial rights may reduce our product revenue.
These agreements also create certain risks. The occurrence of any of the following or other
events may delay product development or impair commercialization of our products:
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not all of our strategic partners are contractually prohibited from developing or
commercializing, either alone or with others, products and services that are similar to
or competitive with our product candidates, and, with respect to our strategic
partnership agreements that do contain such contractual prohibitions or restrictions,
prohibitions or restrictions do not always apply to our partners affiliates and they may
elect to pursue the development of any additional product candidates and pursue
technologies or products either on their own or in collaboration with other parties,
including our competitors, whose technologies or products may be competitive with ours; |
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our strategic partners may under-fund or fail to commit sufficient resources to
marketing, distribution or other development of our products; |
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we may not be able to renew such agreements; |
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our strategic partners may not properly maintain or defend certain intellectual
property rights that may be important to the commercialization of our products; |
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our strategic partners may encounter conflicts of interest, changes in business
strategy or other issues which could adversely affect their willingness or ability to
fulfill their obligations to us (for example, pharmaceutical companies historically have
re-evaluated their priorities following mergers and consolidations, which have been
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delays in, or failures to achieve, scale-up to commercial quantities, or changes to
current raw material suppliers or product manufacturers (whether the change is
attributable to us or the supplier or manufacturer) could delay clinical studies,
regulatory submissions and commercialization of our product candidates; and |
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disputes may arise between us and our strategic partners that could result in the
delay or termination of the development or commercialization of our product candidates,
resulting in litigation or arbitration that could be time-consuming and expensive, or
causing our strategic partners to act in their own self-interest and not in our interest
or those of our shareholders or other stakeholders. |
In addition, our strategic partners can terminate our agreements with them for a number of
reasons based on the terms of the individual agreements that we have entered into with them. If one
or more of these agreements were to be terminated, we would be required to devote additional
resources to developing and commercializing our product candidates, seek a new partner or abandon
this product candidate which would likely cause a drop in the price of our Securities.
We have entered into important strategic partnership agreements relating to certain of our
product candidates for various indications. Detailed information on our research and collaboration
agreements is available in our various reports and disclosure documents filed with the Canadian
securities regulatory authorities and filed with or furnished to the SEC, including the documents
incorporated by reference into this Prospectus. See, for example, Notes 26 and 27 to our audited
consolidated balance sheets as at December 31, 2008 and 2007 and our audited consolidated
statements of earnings (loss), changes in shareholders equity, comprehensive income (loss) and
cash flows for each of the years in the three-year period ended December 31, 2008 included in our
annual report on Form 20-F (filed in Canada with the Canadian securities regulatory authorities in
lieu of an annual information form), which is incorporated by reference into this Prospectus.
We have also entered into a variety of collaborative licensing agreements with various
universities and institutes under which we are obligated to support some of the research expenses
incurred by the university laboratories and pay royalties on future sales of the products. In turn,
we have retained exclusive rights for the worldwide exploitation of results generated during the
collaborations.
In particular, we have entered into an agreement with Tulane University (Tulane), which
provides for the payment by us of single-digit royalties on future worldwide net sales of
cetrorelix and including CetrotideÒ. Tulane is also entitled to receive a low double-digit
participation payment on any lump-sum, periodic or other cash payments received by us from
sub-licensees (see Note 27 to our audited consolidated balance sheets as at December 31, 2008 and
2007 and our audited consolidated statements of earnings (loss), changes in shareholders equity,
comprehensive income (loss) and cash flows for each of the years in the three-year period ended
December 31, 2008 included in our annual report on Form 20-F filed in Canada with the Canadian
securities regulatory authorities in lieu of an annual information form, which is incorporated by
reference into this Prospectus).
We rely on third parties to conduct, supervise and monitor our clinical trials, and those third
parties may not perform satisfactorily.
We rely on third parties such as CROs, medical institutions and clinical investigators to
enroll qualified patients and conduct, supervise and monitor our clinical trials. Our reliance on
these third parties for clinical development activities reduces our control over these activities.
Our reliance on these third parties, however, does not relieve us of our regulatory
responsibilities, including ensuring that our clinical trials are
conducted in accordance with Good Clinical Practice (GCP) guidelines and the investigational plan and protocols contained in an Investigational New Drug
application, or comparable foreign regulatory submission. Furthermore, these third parties may also
have relationships with other entities, some of which may be our competitors. In addition, they may
not complete activities on schedule, or may not conduct our preclinical studies or clinical trials
in accordance with regulatory requirements or our trial design. If these third parties do not
successfully carry out their contractual duties or meet expected deadlines, our efforts to obtain
regulatory approvals for, and commercialize, our product candidates may be delayed or prevented.
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In carrying out our operations, we are dependent on a stable and consistent supply of ingredients
and raw materials.
There can be no assurance that we, our contract manufacturers or our partners, will be able,
in the future, to continue to purchase products from our current suppliers or any other supplier on
terms similar to current terms or at all. An interruption in the availability of certain raw
materials or ingredients, or significant increases in the prices paid by us for them, could have a
material adverse effect on our business, financial condition, liquidity and operating results.
The failure to perform satisfactorily by third parties upon which we rely to manufacture and supply
products may lead to supply shortfalls.
We rely on third parties to manufacture and supply marketed products. We also have certain
supply obligations vis-à-vis our licensing partners who are responsible for the marketing of the
products. To be successful, our products have to be manufactured in commercial quantities in
compliance with quality controls and regulatory requirements. Even though it is our objective to
minimize such risk by introducing alternative suppliers to ensure a constant supply at all times,
we cannot guarantee that we will not experience supply shortfalls and, in such event, we may not be
able to perform our obligations under contracts with our partners.
We are subject to intense competition for our skilled personnel, and the loss of key personnel
or the inability to attract additional personnel could impair our ability to conduct our
operations.
We are highly dependent on our management and our clinical, regulatory and scientific staff,
the loss of whose services might adversely impact our ability to achieve our objectives. Recruiting
and retaining qualified management and clinical, scientific and regulatory personnel is critical to
our success. Competition for skilled personnel is intense, and our ability to attract and retain
qualified personnel may be affected by such competition.
Our strategic partners manufacturing capabilities may not be adequate to effectively commercialize
our product candidates.
Our manufacturing experience to date with respect to our product candidates consists of
producing drug substance for clinical studies. To be successful, these product candidates have to
be manufactured in commercial quantities in compliance with regulatory requirements and at
acceptable costs. Our strategic partners current manufacturing facilities have the capacity to
produce projected product requirements for the foreseeable future, but we will need to increase
capacity if sales continue to grow. Our strategic partners may not be able to expand capacity or to
produce additional product requirements on favorable terms. Moreover, delays associated with
securing additional manufacturing capacity may reduce our revenues and adversely affect our
business and financial position. There can be no assurance that we will be able to meet increased
demand over time.
We are subject to the risk of product liability claims, for which we may not have or be able to
obtain adequate insurance coverage.
The sale and use of our products, in particular our biopharmaceutical products, involve the
risk of product liability claims and associated adverse publicity. Our risks relate to human
participants in our clinical trials, who may suffer unintended consequences, as well as products on
the market whereby claims might be made directly by patients, healthcare providers or
pharmaceutical companies or others selling, buying or using our products. We manage our liability
risks by means of insurance. We maintain liability insurance covering our liability for our
preclinical and clinical studies and for our pharmaceutical products already marketed. However, we
may not have or be able to obtain or maintain sufficient and affordable insurance coverage,
including coverage for potentially very significant legal expenses, and without sufficient coverage
any claim brought against us could have a materially adverse effect on our business, financial
condition or results of operations.
Our business involves the use of hazardous materials which requires us to comply with environmental
and occupational safety laws regulating the use of such materials. If we violate these laws, we
could be subject to significant fines, liabilities or other adverse consequences.
Our discovery and development processes involve the controlled use of hazardous and
radioactive materials. We are subject to federal, provincial and local laws and regulations
governing the use, manufacture, storage, handling and disposal of such materials and certain waste
products. The risk of accidental contamination or injury from these materials cannot be completely
eliminated. In the event of an accident or a failure to comply with environmental or occupational
safety laws, we could be held liable for any damages that result, and any such liability could
exceed our resources. We may not be adequately insured against this type of liability. We may be
required to incur significant costs to comply with environmental laws and regulations in the
future, and our operations, business or assets may be materially adversely affected by current or
future environmental laws or regulations.
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Legislative actions, new accounting pronouncements and higher insurance costs are likely to impact
our future financial position or results of operations.
Changes in financial accounting standards or implementation of accounting standards may cause
adverse, unexpected revenue or expense fluctuations and affect our financial position or results of
operations. New pronouncements and varying interpretations of pronouncements have occurred with
greater frequency and are expected to occur in the future, and we may make or be required to make
changes in our accounting policies in the future. Compliance with changing regulations of corporate
governance and public disclosure, notably with respect to internal controls over financial
reporting, may result in additional expenses. Changing laws, regulations and standards relating to
corporate governance and public disclosure are creating uncertainty for companies such as ours, and
insurance costs are increasing as a result of this uncertainty.
We will report under International Financial Reporting Standards for our interim and annual
consolidated financial statements for the financial year ending December 31, 2011.
The Accounting Standards Board of the Canadian Institute of Chartered Accountants has
announced that Canadian publicly accountable enterprises are required to adopt International
Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board,
effective January 1, 2011. We will be required to report under IFRS for our interim and annual
consolidated financial statements for the financial year ending December 31, 2011.
Although IFRS uses a conceptual framework similar to Canadian GAAP, we will need to address
differences in accounting policies. We are currently considering the impact that IFRS will have on
our financial statements.
We may incur losses associated with foreign currency fluctuations.
Our operations are in many instances conducted in currencies other than the U.S. dollar
(principally Euros), and fluctuations in the value of foreign currencies could cause us to incur
currency exchange losses. We do not currently employ a hedging strategy against exchange rate risk.
We cannot say with any assurance that we will not suffer losses as a result of unfavorable
fluctuations in the exchange rates between the United States dollar, the euro, the Canadian dollar
and other currencies.
We may not be able to successfully integrate acquired businesses.
Future acquisitions may not be successfully integrated. The failure to successfully integrate
the personnel and operations of businesses which we may acquire in the future with ours could have
a material adverse effect on our operations and results.
Risks Related to the Securities
Our share price is volatile, which may result from factors outside of our control. If we experience
low trading volume or if our Common Shares are delisted from the TSX or NASDAQ, you may have
difficulty selling your Securities.
Our Common Shares are currently listed and traded only on the TSX and NASDAQ. Our valuation
and share price since the beginning of trading after our initial listings, first in Canada and then
in the United States, have had no meaningful relationship to current or historical financial
results, asset values, book value or many other criteria based on conventional measures of the
value of shares.
During the year ended December 31, 2009, the closing price of our Common Shares ranged from
Cdn$0.57 to Cdn$3.11 per share on the TSX, and from U.S.$0.46 to U.S.$2.83 on the NASDAQ. Our share
price may be affected by developments directly affecting our business and by developments out of
our control or unrelated to us. The biopharmaceutical sector in particular, and the stock market
generally, are vulnerable to abrupt changes in investor sentiment. Prices of shares and trading
volume of companies in the biopharmaceutical industry can swing dramatically in ways unrelated to,
or that bear a disproportionate relationship to, operating performance. Our share price and trading
volume may fluctuate based on a number of factors including, but not limited to:
|
|
|
clinical and regulatory developments regarding our product candidates; |
|
|
|
|
delays in our anticipated development or commercialization timelines; |
- 19 -
|
|
|
developments regarding current or future third-party collaborators; |
|
|
|
|
other announcements by us regarding technological, product development or other
matters; |
|
|
|
|
arrivals or departures of key personnel; |
|
|
|
|
governmental or regulatory action affecting our product candidates and our
competitors products in the United States, Canada and other countries; |
|
|
|
|
developments or disputes concerning patent or proprietary rights; |
|
|
|
|
actual or anticipated fluctuations in our revenues or expenses; |
|
|
|
|
general market conditions and fluctuations for the emerging growth and
biopharmaceutical market sectors; and |
|
|
|
|
economic conditions in the United States, Canada or abroad. |
Our listing on both the TSX and NASDAQ may increase price volatility due to various factors
including: different ability to buy or sell our Common Shares; different market conditions in
different capital markets; and different trading volumes. In addition, low trading volume may
increase the price volatility of our Common Shares. A thin trading market could cause the price of
our Common Shares to fluctuate significantly more than the stock market as a whole.
In the past, following periods of large price declines in the public market price of a
companys securities, securities class action litigation has often been initiated against that
company. Litigation of this type could result in substantial costs and diversion of managements
attention and resources, which would adversely affect our business. Any adverse determination in
litigation could also subject us to significant liabilities.
We must meet continuing listing requirements to maintain the listing of our Common Shares on
the TSX and NASDAQ. For continued listing, NASDAQ requires, among other things, that listed
securities maintain a minimum closing bid price of not less than U.S.$1.00 per share. On January
22, 2010, we announced that we had received a letter from the NASDAQ Listing Qualifications
Department indicating that the minimum closing bid price of the Common Shares had fallen below
U.S.$1.00 for 30 consecutive trading days, and therefore, Æterna Zentaris was not in compliance
with NASDAQ Listing Rule 5450(a)(1) (the Rule). In accordance with NASDAQ Listing Rule
5810(C)(3)(a), we have been provided a grace period of 180 calendar days, or until July 20, 2010,
to regain compliance with this requirement. We can regain compliance with the Rule if the bid price
of our Common Shares closes at U.S.$1.00 or higher for a minimum of ten consecutive business days
during the grace period, although NASDAQ may, in its discretion, require us to maintain a minimum
closing bid price of at least U.S.$1.00 per share for a period in excess of ten consecutive
business days before determining that we have demonstrated the ability to maintain long-term
compliance.
If we are unsuccessful in meeting the minimum bid requirement by July 20, 2010, NASDAQ will
provide notice to us that our Common Shares will be subject to delisting from the NASDAQ Global
Market. If the Company receives a delisting notification, we may appeal to the Listing
Qualifications Panel or apply to transfer the listing of our Common Shares to the NASDAQ Capital
Market if we satisfy at such time all of the initial listing standards on the NASDAQ Capital
Market, other than compliance with the minimum closing bid price requirement. If the application to
the NASDAQ Capital Market is approved, then we will have an additional 180-day grace period in
order to regain compliance with the minimum bid price requirement while listed on the NASDAQ
Capital Market. There can be no assurance that we will meet the requirements for continued listing
on the NASDAQ Global Market or whether our application to the NASDAQ Capital Market will be
approved or that any appeal would be granted by the Listing Qualifications Panel.
Our largest shareholders have influence over our business and corporate matters, including those
requiring shareholder approval. This could delay or prevent a change in control. Sales of Common
Shares by such shareholders could have an impact on the market price of our Securities.
Our two largest shareholders, which held 13.97% and 12.94% of our outstanding Common Shares as
of the date of this Prospectus, have certain rights to nominate members of our Board of Directors
as well as influence over our business and corporate matters, including those requiring shareholder
approval. This could delay or prevent a change in control. Sales of Common Shares by such
shareholders could have an impact on the price of our Securities.
- 20 -
We do not intend to pay dividends in the near future.
To date, we have not declared or paid any dividends on our Common Shares. We currently intend
to retain our future earnings, if any, to finance further research and the expansion of our
business. As a result, the return on an investment in our Securities will, for the foreseeable
future, depend upon any future appreciation in value. There is no guarantee that our Securities
will appreciate in value or even maintain the price at which shareholders have purchased their
Securities.
Risks Related to the Issuance of Securities under this Prospectus
An active market may not develop for the Warrants, which may hinder your ability to liquidate your
investment.
Each issuance of Warrants will be a new issue of securities with no established trading
market, and we do not currently intend to list them on any securities exchange. A dealer may intend
to make a market in the Warrants after their issuance pursuant to this Prospectus; however, a
dealer may not be obligated to do so and may discontinue such market-making at any time. As a
result, we cannot assure you that an active trading market will develop for any series of the
Warrants. In addition, subsequent to their initial issuance, the Warrants may trade at a discount
to their initial offering price, depending upon the value of the underlying Common Shares and upon
our prospects or the prospects for companies in our industry generally and other factors, including
those described herein.
A large number of Common Shares may be issued and subsequently sold upon the exercise of the
Warrants. The sale or availability for sale of these Warrants may depress the price of our Common
Shares.
The number of Common Shares that will be initially issuable upon the exercise of Warrants will
be determined by the particular terms of each issue of Warrants and will be described in the
relevant Prospectus Supplement. To the extent that purchasers of Warrants sell Common Shares issued
upon the exercise of the Warrants, the market price of our Common Shares may decrease due to the
additional selling pressure in the market. The risk of dilution from issuances of Common Shares
underlying the Warrants may cause shareholders to sell their Common Shares, which could further
contribute to any decline in the Common Share price.
The sale of Common Shares issued upon exercise of the Warrants could encourage short sales by third
parties which could further depress the price of the Common Shares.
Any downward pressure on the price of Common Shares caused by the sale of Common Shares issued
upon the exercise of the Warrants could encourage short sales by third parties. In a short sale, a
prospective seller borrows Common Shares from a shareholder or broker and sells the borrowed Common
Shares. The prospective seller hopes that the Common Share price will decline, at which time the
seller can purchase Common Shares at a lower price for delivery back to the lender. The seller
profits when the Common Share price declines because it is purchasing Common Shares at a price
lower than the sale price of the borrowed Common Shares. Such sales could place downward pressure
on the price of our Common Shares by increasing the number of Common Shares being sold, which could
further contribute to any decline in the market price of our Common Shares.
We cannot predict the actual number of Common Shares that we will issue upon the exercise of the
Warrants. The number of Common Shares that we will issue under the Warrants may depend on the
market price of our Common Shares.
The actual number of Common Shares that we will issue upon the exercise of the Warrants is
uncertain and will be determined, or made determinable, by the particular terms of each issue of
Warrants and will be described in the relevant Prospectus Supplement. The number of Common Shares
issuable upon the exercise of the Warrants may fluctuate based on the market price of our Common
Shares. Holders of Warrants may receive more Common Shares if our Common Share price declines.
Future issuances of securities and hedging activities may depress the trading price of our Common
Shares.
Any issuance of equity securities or securities convertible into or exchangeable for equity
securities after the offering of Securities under this Prospectus, including the issuance of Common
Shares upon the exercise of stock options and upon exercise of the Warrants, could dilute the
interests of our existing shareholders, and could substantially decrease the trading price of our
Common Shares. We may issue equity securities in the future for a number of reasons, including to
finance our operations and business strategy, to satisfy
- 21 -
our obligations upon the exercise of options or for other reasons. Our stock option plan
generally permits us to have outstanding, at any given time, stock options that are exercisable for
a maximum number of Common Shares equal to 11.4% of all then issued and outstanding Common Shares.
As of December 31, 2009, there were:
|
|
|
63,089,954 Common Shares issued and outstanding; |
|
|
|
|
No issued and outstanding Preferred Shares (as defined below); |
|
|
|
|
4,110,603 Common Shares issuable upon exercise of outstanding warrants; and |
|
|
|
|
6,213,922 stock options outstanding. |
In addition, the price of Securities could also be affected by possible sales of Securities by
investors who view other investment vehicles as more attractive means of equity participation in us
and by hedging or arbitrage trading activity that may develop involving our Securities. This
hedging or arbitrage could, in turn, affect the trading price of our Securities.
CHANGES IN LOAN AND CAPITAL STRUCTURE
Since
September 30, 2009, there has been no material change in our loan and capital structure on a consolidated basis except for the issuance of Common Shares and warrants to purchase Common Shares, as fully described in Note 13 to our unaudited interim consolidated financial statements as at and for the three and nine-month periods ended September 30, 2009 and 2008, which financial statements
are incorporated by reference into this Prospectus. Upon completion of such issuance of Common
Shares and warrants, the Company received proceeds of approximately U.S.$5.5 million, less cash transaction costs of approximately U.S.$0.4 million.
As of September 30, 2009, we had no outstanding long-term debt.
DESCRIPTION OF SHARE CAPITAL
Our authorized share capital structure consists of an unlimited number of shares of the
following classes (all classes are without nominal or par value): Common Shares; and first
preferred shares (the First Preferred Shares) and second preferred shares (the Second Preferred
Shares and, together with the First Preferred Shares, the Preferred Shares), both issuable in
series. As of December 31, 2009, there were 63,089,954 Common Shares outstanding. No Preferred
Shares of the Company have been issued to date.
Common Shares
The holders of the Common Shares are entitled to one vote for each Common Share held by them
at all meetings of shareholders, except meetings at which only shareholders of a specified class of
shares are entitled to vote. In addition, the holders are entitled to receive dividends if, as and
when declared by the Companys Board of Directors on the Common Shares. Finally, the holders of the
Common Shares are entitled to receive the remaining property of the Company upon any liquidation,
dissolution or winding-up of the affairs of the Company, whether voluntary or involuntary.
Shareholders have no liability to further capital calls as all shares issued and outstanding are
fully paid and non-assessable.
Preferred Shares
The First and Second Preferred Shares are issuable in series with rights and privileges
specific to each class. The holders of Preferred Shares are generally not entitled to receive
notice of or to attend or vote at meetings of shareholders. The holders of First Preferred Shares
are entitled to preference and priority to any participation of holders of Second Preferred Shares,
Common Shares or shares of any other class of shares of the share capital of the Company ranking
junior to the First Preferred Shares with respect to dividends and, in the event of the liquidation
of the Company, the distribution of its property upon its dissolution or winding-up, or the
distribution of all or part of its assets among the shareholders, to an amount equal to the value
of the consideration paid in respect of such shares outstanding, as credited to the issued and
paid-up share capital of the Company, on an equal basis, in proportion to the amount of their
respective claims in regard to such shares held by them. The holders of Second Preferred Shares are
entitled to preference and priority to any participation of holders of Common Shares or shares of
any other class of shares of the share capital of the Company ranking junior to the Second
Preferred Shares with respect to dividends and, in the event of the liquidation of the Company, the
distribution of its property upon its dissolution or winding-up, or the distribution of all or part
of its assets among the
- 22 -
shareholders, to an amount equal to the value of the consideration paid in respect of such
shares outstanding, as credited to the issued and paid-up share capital of the Company, on an equal
basis, in proportion to the amount of their respective claims in regard to such shares held by
them.
Our Board of Directors may, from time to time, provide for additional series of Preferred
Shares to be created and issued, but the issuance of any Preferred Shares is subject to the general
duties of the directors under the Canada Business Corporations Act to act honestly and in good
faith with a view to the best interests of the Company and to exercise the care, diligence and
skill that a reasonably prudent person would exercise in comparable circumstances.
Additional information on our share capital is provided in Item 10.Additional Information
in our annual report on Form 20-F for the financial year ended December 31, 2008 (filed in Canada
with the Canadian securities regulatory authorities in lieu of an annual information form)
incorporated by reference into this Prospectus.
DESCRIPTION OF WARRANTS
Warrants may be offered separately or together with Common Shares. Each series of Warrants
will be issued under a separate warrant agreement or indenture to be entered into between us and
one or more purchasers of such Warrants or with banks or trust companies acting as warrant agent.
The applicable Prospectus Supplement will include details of the warrant agreements covering the
Warrants being offered. The warrant agent will act solely as our agent and will not assume a
relationship of agency with any holders of Warrant certificates or beneficial owners of Warrants.
The particular terms of each issue or series of Warrants will be described in the related
Prospectus Supplement. This description will include, where applicable:
|
|
|
the designation and aggregate number of Warrants offered; |
|
|
|
|
the price at which the Warrants will be offered; |
|
|
|
|
the currency or currency unit in which the Warrants are denominated; |
|
|
|
|
the date on which the right to exercise the Warrants will commence and the date on
which the right will expire; |
|
|
|
|
the number of Common Shares that may be purchased upon exercise of each Warrant and
the price at which and currency or currencies in which that amount of Common Shares may
be purchased upon exercise of each Warrant; |
|
|
|
|
if offered in conjunction with the Common Shares, the number of Warrants that will
be offered with each Common Share; |
|
|
|
|
the date or dates, if any, on or after which the Warrants and the related Common
Shares will be transferable separately; |
|
|
|
|
the minimum or maximum amount, if any, of Warrants that may be exercised at any one
time; |
|
|
|
|
whether the Warrants will be subject to redemption or call, and, if so, the terms
of such redemption or call provisions; and |
|
|
|
|
any other terms, conditions and rights (or limitations on such rights) of the
Warrants. |
We reserve the right to set forth in a Prospectus Supplement specific terms of the Warrants
that are not within the options and parameters set forth in this Prospectus. In addition, to the
extent that any particular terms of the Warrants described in a Prospectus Supplement differ from
any of the terms described in this Prospectus, the description of such terms set forth in this
Prospectus shall be deemed to have been superseded by the description of such differing terms set
forth in such Prospectus Supplement with respect to such Warrants.
- 23 -
PRICE RANGE AND TRADING VOLUME
Our Common Shares are listed and posted for trading on NASDAQ under the symbol AEZS and on
the TSX under the symbol AEZ. The following table indicates, for the relevant periods, the high
and low closing prices and the average daily trading volume of our Common Shares on NASDAQ and on the TSX:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NASDAQ (U.S.$) |
|
TSX (Cdn$) |
|
|
High |
|
Low |
|
Volume |
|
High |
|
Low |
|
Volume |
2009 |
|
|
2.83 |
|
|
|
0.46 |
|
|
|
385,128 |
|
|
|
3.11 |
|
|
|
0.57 |
|
|
|
155,194 |
|
2008 |
|
|
1.80 |
|
|
|
0.40 |
|
|
|
29,774 |
|
|
|
1.85 |
|
|
|
0.44 |
|
|
|
46,277 |
|
2007 |
|
|
4.36 |
|
|
|
1.46 |
|
|
|
53,116 |
|
|
|
5.10 |
|
|
|
1.47 |
|
|
|
111,144 |
|
2006 |
|
|
7.46 |
|
|
|
4.05 |
|
|
|
42,679 |
|
|
|
8.60 |
|
|
|
4.68 |
|
|
|
124,079 |
|
2005 |
|
|
6.36 |
|
|
|
4.18 |
|
|
|
39,460 |
|
|
|
7.65 |
|
|
|
4.92 |
|
|
|
61,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth quarter |
|
|
0.60 |
|
|
|
0.40 |
|
|
|
28,090 |
|
|
|
0.72 |
|
|
|
0.44 |
|
|
|
55,510 |
|
Third quarter |
|
|
1.36 |
|
|
|
0.59 |
|
|
|
17,600 |
|
|
|
1.42 |
|
|
|
0.61 |
|
|
|
30,641 |
|
Second quarter |
|
|
1.80 |
|
|
|
1.00 |
|
|
|
37,876 |
|
|
|
1.85 |
|
|
|
1.01 |
|
|
|
42,791 |
|
First quarter |
|
|
1.73 |
|
|
|
0.77 |
|
|
|
35,813 |
|
|
|
1.78 |
|
|
|
0.75 |
|
|
|
56,384 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth quarter |
|
|
1.25 |
|
|
|
0.80 |
|
|
|
317,523 |
|
|
|
1.40 |
|
|
|
0.83 |
|
|
|
111,373 |
|
Third quarter |
|
|
2.83 |
|
|
|
0.89 |
|
|
|
1,056,206 |
|
|
|
3.11 |
|
|
|
0.97 |
|
|
|
375,987 |
|
Second quarter |
|
|
2.35 |
|
|
|
0.89 |
|
|
|
113,553 |
|
|
|
2.63 |
|
|
|
1.06 |
|
|
|
99,844 |
|
First quarter |
|
|
0.97 |
|
|
|
0.46 |
|
|
|
32,455 |
|
|
|
1.25 |
|
|
|
0.57 |
|
|
|
33,877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Last twelve months |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mar-101 |
|
|
0.84 |
|
|
|
0.82 |
|
|
|
111,463 |
|
|
|
0.86 |
|
|
|
0.83 |
|
|
|
58,122 |
|
Feb-10 |
|
|
0.87 |
|
|
|
0.81 |
|
|
|
102,265 |
|
|
|
0.91 |
|
|
|
0.86 |
|
|
|
38,021 |
|
Jan-10 |
|
|
0.93 |
|
|
|
0.80 |
|
|
|
489,389 |
|
|
|
0.99 |
|
|
|
0.83 |
|
|
|
109,245 |
|
Dec-09 |
|
|
1.12 |
|
|
|
0.80 |
|
|
|
341,716 |
|
|
|
1.17 |
|
|
|
0.83 |
|
|
|
140,062 |
|
Nov-09 |
|
|
1.10 |
|
|
|
0.98 |
|
|
|
191,089 |
|
|
|
1.17 |
|
|
|
1.05 |
|
|
|
97,410 |
|
Oct-09 |
|
|
1.25 |
|
|
|
0.99 |
|
|
|
408,270 |
|
|
|
1.40 |
|
|
|
1.07 |
|
|
|
96,648 |
|
Sept-09 |
|
|
1.38 |
|
|
|
0.89 |
|
|
|
1,240,716 |
|
|
|
1.46 |
|
|
|
0.98 |
|
|
|
259,348 |
|
Aug-09 |
|
|
2.83 |
|
|
|
0.89 |
|
|
|
1,567,974 |
|
|
|
3.11 |
|
|
|
0.97 |
|
|
|
704,210 |
|
Jul-09 |
|
|
2.62 |
|
|
|
1.67 |
|
|
|
391,576 |
|
|
|
2.80 |
|
|
|
1.95 |
|
|
|
188,891 |
|
Jun-09 |
|
|
2.35 |
|
|
|
1.73 |
|
|
|
257,401 |
|
|
|
2.63 |
|
|
|
1.97 |
|
|
|
185,032 |
|
May-09 |
|
|
1.69 |
|
|
|
1.11 |
|
|
|
42,220 |
|
|
|
1.86 |
|
|
|
1.31 |
|
|
|
56,320 |
|
Apr-09 |
|
|
1.32 |
|
|
|
0.89 |
|
|
|
30,792 |
|
|
|
1.59 |
|
|
|
1.06 |
|
|
|
51,967 |
|
Mar-09 |
|
|
0.97 |
|
|
|
0.65 |
|
|
|
54,736 |
|
|
|
1.25 |
|
|
|
0.83 |
|
|
|
54,586 |
|
|
|
|
1 |
|
Up to and including March 11, 2010. |
PRIOR
SALES
On June 23, 2009, we completed a registered direct offering pursuant to which we issued
5,319,149 units, each unit being comprised of one Common Share and one warrant to purchase 0.35 of
a Common Share, for a price of U.S.$1.88 per unit. Each such warrant has an exercise price of
U.S.$2.06 per share. We also issued compensation warrants to purchase up to an aggregate of 287,234
Common Shares to Rodman & Renshaw LLC (and certain of its
representatives), who acted as placement agent for this offering, which warrants have an
exercise price of U.S.$2.35 per share.
In addition, on October 23, 2009, we completed a second registered direct offering pursuant to
which we issued 4,583,335 units, each unit being comprised of one Common Share and one warrant to
purchase 0.40 of a Common Share, for a purchase price of U.S.$1.20 per unit. Each such warrant has
an exercise price of U.S.$1.25 per share. We also issued compensation warrants to purchase up to an
aggregate of 128,333 Common Shares to Rodman & Renshaw LLC, who acted as placement agent for this
offering, which warrants have an exercise price of U.S.$1.50 per share.
On December 9, 2009, we granted an aggregate of 1,448,422 stock options to acquire Common
Shares at an exercise price of Cdn$0.95 to our directors, executive officers and employees pursuant to our stock option plan.
- 24 -
USE OF PROCEEDS
Unless otherwise specified in a Prospectus Supplement, the net proceeds resulting from the
issuance of Securities will be used for the general corporate purposes of Æterna Zentaris, which
may include development costs of our product pipeline. All expenses relating to an offering of
Securities and any compensation paid to underwriters, dealers or agents, as the case may be, will
be paid out of our general funds or from the proceeds of any offering under this Prospectus or a
Prospectus Supplement. The use of proceeds will be specified in the
Prospectus Supplement relating to a particular offering of Securities, as required by applicable securities legislation.
EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the various expenses in connection with the sale and
distribution of the securities being registered. We will bear all of the expenses shown below.
|
|
|
|
|
Securities and Exchange Commission registration fee |
|
US$ |
4,278 |
|
Printing and engraving expenses |
|
|
* |
|
Legal fees and expenses |
|
|
* |
|
Accounting fees and expenses |
|
|
* |
|
Transfer agent fees and expenses |
|
|
* |
|
Miscellaneous |
|
|
* |
|
|
|
|
|
Total |
|
US$* |
|
|
|
|
|
|
|
* |
|
The amount of securities and number of offerings are indeterminable, and the expenses cannot
be estimated at this time. |
PLAN OF DISTRIBUTION
We may offer and sell the Securities to or through underwriters or dealers purchasing as
principals, and we may also sell the Securities to one or more purchasers directly or through
agents. Securities may be sold from time to time in one or more transactions at a fixed price or
prices, or at non-fixed prices.
If offered on a non-fixed price basis, the Securities may be offered at prevailing market
prices at the time of sale or at prices to be negotiated with purchasers. The prices at which the
Securities may be offered may vary as between purchasers and during the period of distribution.
Consequently, any dealers overall compensation will increase or decrease by the amount by which
the aggregate price paid for the Securities by the purchasers exceeds or is less than the gross
proceeds paid by the dealers, acting as principals, to us.
If, in connection with the offering of Securities at a fixed price or prices, the underwriters
have made a bona fide effort to sell all of the Securities at the initial offering price fixed in
the applicable Prospectus Supplement, the public offering price may be decreased and thereafter
further changed, from time to time, to an amount not greater than the initial public offering price
fixed in such Prospectus Supplement, in which case the compensation realized by the underwriters
will be decreased by the amount that the aggregate price paid by purchasers for the Securities is
less than the gross proceeds paid by the underwriters to us.
A Prospectus Supplement will identify each underwriter, dealer or agent engaged by us, as the
case may be, in connection with the offering and sale of a particular issue of Securities, and will
also set forth the terms of the offering, including the public offering price (or the manner of
determination thereof if offered on a non-fixed price basis), the proceeds to us and any
compensation payable to the underwriters, dealers or agents.
Under agreements which may be entered into by Æterna Zentaris, underwriters, dealers and
agents who participate in the distribution of the Securities may be entitled to indemnification by
us against certain liabilities, including liabilities arising out of any misrepresentation in this
Prospectus and the documents incorporated by reference herein, other than liabilities arising out
of any misrepresentation made by underwriters, dealers or agents who participate in the offering of
the Securities.
Under
no circumstances will the fee, commission or discount received or to be received by any
underwriter, placement agent or other FINRA member or independent broker-dealer exceed
8% of the gross proceeds of any public offering of the Securities in the United States
pursuant to this Prospectus.
Each issue of Warrants will be a new issue of securities with no established trading market.
In connection with any offering of Securities, the underwriters, dealers or agents, as the case may
be, may over-allot or effect transactions which stabilize or maintain the market price of the
Securities of such series or issue at a level above that which might otherwise prevail in the open
market. Such transactions, if commenced, may be discontinued at any time. Any underwriters, dealers
or agents to or through whom Securities are sold by us for public offering and sale may make a
market in the Securities, but such underwriters, dealers or agents will not be obligated to do so
and may discontinue any market making at any time without notice. No assurance can be given that a
trading market in the Securities of any series or issue will develop or as to the liquidity of any
such trading market for the Securities.
- 25 -
CERTAIN INCOME TAX CONSIDERATIONS
The applicable Prospectus Supplement will describe certain Canadian federal income tax
consequences to an investor of acquiring any Securities offered thereunder, including, for
investors who are non-residents of Canada, whether the payments of dividends (or any other amounts)
on the Securities, if any, will be subject to Canadian non-resident withholding tax.
The applicable Prospectus Supplement may also describe certain U.S. federal income tax
consequences of the acquisition, ownership and disposition of any Securities offered thereunder by
an initial investor who is a U.S. person (within the meaning of the U.S. Internal Revenue Code),
including, to the extent applicable, any such consequences relating to Securities payable in a
currency other than the U.S. dollar, issued at an original issue discount for U.S. federal income
tax purposes or containing early redemption provisions or other special items.
LEGAL MATTERS
Unless otherwise specified in the Prospectus Supplement relating to any offering of
Securities, certain matters under Canadian law relating to the offering of the Securities under
this Prospectus will be passed upon for us by Ogilvy Renault LLP, Montreal, Canada and certain
legal matters under U.S. law will be passed upon for us by Ropes & Gray LLP. In addition, certain
legal matters in connection with any offering of Securities under this Prospectus will be passed
upon for any underwriters, dealers or agents by counsel to be designated at the time of the
offering by such underwriters, dealers or agents with respect to matters of Canadian and U.S. law.
The partners and associates of Ogilvy Renault LLP as a group beneficially own, directly or
indirectly, less than 1% of our outstanding Common Shares.
- 26 -
EXPERTS
The consolidated financial statements, financial statement
schedules and managements assessment of the effectiveness of internal control over financial reporting
(which is included in Managements Report on Internal Control over Financial Reporting) incorporated in this
Prospectus by reference to the Annual Report on Form 20-F of Aeterna Zentaris Inc. for the year ended
December 31, 2008 have been so incorporated in reliance on the report of PricewaterhouseCoopers LLP,
an independent registered public accounting firm, given on the authority of said firm as experts in
auditing and accounting.
RECONCILIATION TO U.S. GAAP
Our audited annual consolidated balance sheets as at December 31, 2008 and 2007 and our
audited annual consolidated statements of earnings (loss), changes in shareholders equity,
comprehensive income (loss) and cash flows for each of the years in the three-year period ended
December 31, 2008 and the financial statement schedules thereto, included in our annual report on
Form 20-F for the financial year ended December 31, 2008 (filed in Canada with the Canadian
securities authorities in lieu of an annual information form), filed with the SEC on March 30,
2009, were prepared in accordance with Canadian GAAP that differ in some respects from U.S. GAAP.
We have reconciled our financial results for significant differences between Canadian GAAP and U.S.
GAAP in accordance with the instructions of Item 18 of SEC Form 20-F as set out in Note 27 to our
audited annual consolidated financial statements as of and for the
financial year ended December 31, 2008.
Our unaudited interim consolidated financial statements for the three- and nine-month periods
ended September 30, 2009 and 2008, including the notes thereto, included as Exhibit 99.1 to our
report on Form 6-K furnished to the SEC on November 12, 2009, were prepared in accordance with
Canadian GAAP. Financial statement readers should understand that there are certain significant
differences between Canadian GAAP and U.S. GAAP. In order to facilitate the understanding of the
differences that would have arisen had these financial statements been presented in accordance with
U.S. GAAP, refer to Note 27 to our audited annual consolidated financial statements as of and for
the year ended December 31, 2008 and to Note 14 to our unaudited interim consolidated financial
statements for the three- and nine-month periods ended September 30, 2009 and 2008. In addition, financial statement readers should refer to Note 2
to our unaudited interim consolidated financial statements for the three- and nine-month periods
ended September 30, 2009 and 2008 that describes Canadian GAAP accounting changes that have been
adopted by the Company during that period and to Note 14 that describes U.S. GAAP accounting changes that
have been adopted by the Company during the same period. The adoption of these accounting policies by the Company
is not expected to result in any additional significant differences in 2009 between Canadian GAAP
and U.S. GAAP.
- 27 -