F-10/A
As filed
with the Securities and Exchange Commission on July 15, 2010
Registration
No. 333-167915
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1 to
FORM F-10
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Æterna Zentaris Inc.
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of Registrants name into English)
|
|
|
|
|
Canada
(Province or other jurisdiction of
incorporation or organization)
|
|
2834
(Primary Standard Industrial
Classification Code Number)
|
|
Not Applicable
(I.R.S. Employer
Identification Number) |
1405 du Parc-Technologique Boulevard
Quebec City, Quebec
Canada, G1P 4P5
(418) 652-8525
(Address and telephone number of Registrants principal executive offices)
Æterna Zentaris, Inc.
20 Independence Boulevard,
Warren, New Jersey 07059-2731
(418) 652-8525
(Name, address (including zip code) and telephone number (including area code) of agent for service in the United States)
Copies to:
|
|
|
|
|
|
|
|
|
|
Dennis Turpin
Æterna Zentaris Inc.
1405 du Parc-Technologique Boulevard
Quebec City, Quebec
Canada, G1P 4P5
(418) 652-8525
|
|
Elliot Shapiro, Esq.
Ogilvy Renault LLP
1 Place Ville Marie, Suite 2500
Montreal, Quebec
Canada, H3B 1R1
(514) 847-4747
|
|
Patrick OBrien, Esq.
Ropes & Gray LLP
One International Place
Boston, MA 02110-2624
(617) 951-7000 |
Approximate date of commencement of proposed sale of the securities to the public:
From time to time after the effective date of this Registration Statement.
Province of Quebec, Canada
(Principal jurisdiction regulating this offering)
It is proposed that this filing shall become effective (check appropriate box):
A. |
|
o |
|
upon filing with the Commission, pursuant to Rule 467(a) (if in connection with an
offering being made contemporaneously in the United States and Canada). |
B. |
|
þ |
|
at some future date (check the appropriate box below). |
|
1. |
|
o |
|
pursuant to Rule 467(b) on (date) at (time) (designate a time not sooner than 7
calendar days after filing). |
|
2. |
|
o |
|
pursuant to Rule 467(b) on (date) at (time) (designate a time 7 calendar days
or sooner after filing) because the securities regulatory authority in the review
jurisdiction has issued a receipt or notification of clearance on (date). |
|
3. |
|
þ |
|
pursuant to Rule 467(b) as soon as practicable after notification of the
Commission by the Registrant or the Canadian securities regulatory authority of the review
jurisdiction that a receipt or notification of clearance has been issued with respect
hereto. |
|
4. |
|
o |
|
after the filing of the next amendment to this Form (if preliminary material is being filed). |
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to the home jurisdictions shelf prospectus offering procedures, check
the following box. þ
The Registrant hereby amends
this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registration
Statement shall become effective as provided in Rule 467 under the Securities Act of 1933 or on such date as the
Commission, acting pursuant to Section 8(a) of the Act, may
determine.
Explanatory Note: The Registrant hereby amends its Registration Statement on Form F-10
filed with the Commission on June 30, 2010, to include the final short form base shelf prospectus
filed with the Canadian securities commissions on the date hereof, relating to the future offering
of securities of the Registrant in Canada and the United States.
The Registrant previously paid a registration fee of $6,061 in relation to the registration of up
to US$85,000,000 aggregate maximum offering price of securities under the original Registration
Statement on Form F-10 filed with the Commission on June 30, 2010.
PART I
INFORMATION REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
I-1
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.
This short form
base shelf prospectus has been filed under legislation in each
of the provinces of Canada that permits certain information
about these securities to be determined after this short form
base shelf prospectus has become final and that permits the
omission from this short form base shelf prospectus of that
information. The legislation requires the delivery to purchasers
of a prospectus supplement containing the omitted information
within a specified period of time after agreeing to purchase any
of these securities.
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.
|
|
New
Issue and/or Secondary Offering |
Dated
July 15, 2010
|
SHORT FORM BASE SHELF PROSPECTUS
U.S.$85,000,000
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.$85,000,000 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 and are permitted, under a
multi-jurisdictional disclosure system (MJDS)
adopted by the U.S. and Canada, to prepare this Prospectus in
accordance with Canadian disclosure requirements. Prospective
investors should be aware that such requirements are different
from those of the U.S. The financial statements incorporated
herein by reference have been prepared in accordance with
Canadian generally accepted accounting principles
(GAAP) and are subject to Canadian auditing and
auditor independence standards, and thus 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 Note 26 entitled Differences
between Canadian and US GAAP to 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 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, 2010 (available
electronically at www.sec.gov), and in Note 11 entitled
Differences between Canadian and US GAAP to our
unaudited consolidated balance sheets as at March 31, 2010
and our unaudited consolidated statements of operations and
comprehensive loss, changes in shareholders equity and
cash flows for each of the three-month periods ended
March 31, 2010 and 2009, which was furnished to the SEC on
May 13, 2010, each of which is incorporated by reference
into this Prospectus.
Prospective investors should be aware that the acquisition of
the Securities described herein may have tax consequences both
in Canada and in the U.S. Such consequences for investors who
are resident in, or citizens of, the U.S. or Canada may not be
described fully herein. Prospective investors should read the
tax discussion in this Prospectus and any applicable Prospectus
Supplement.
The enforcement of civil liabilities under U.S. federal
securities laws may be affected adversely by the fact that we
are incorporated under the laws of Canada, that 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 that a substantial portion of our assets and
the assets of such persons are located outside the United
States. See Enforceability of Civil Liabilities.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SEC NOR HAS THE SEC PASSED UPON THE ACCURACY OR ADEQUACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENCE.
Investing in the Securities involves risk. See
Risk Factors beginning on page 9.
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.
On July 14, 2010, the last reported sale price of our
Common Shares on the TSX was C$1.24 per share and the last
reported sale price of our Common Shares on the NASDAQ was
$1.19 per share. 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.
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
|
|
|
|
|
1
|
|
|
3
|
|
|
3
|
|
|
3
|
|
|
4
|
|
|
4
|
|
|
9
|
|
|
23
|
|
|
24
|
|
|
24
|
|
|
26
|
|
|
26
|
|
|
27
|
|
|
27
|
|
|
27
|
|
|
28
|
|
|
28
|
|
|
28
|
EX-5.1 |
EX-5.2 |
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:
|
|
|
|
(a)
|
our annual report on
Form 20-F
for the financial year ended December 31, 2009 (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, 2010 and which includes our consolidated
balance sheets as at December 31, 2009 and 2008 and our
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 dated March 23,
2010 on our consolidated financial statements, financial
statement schedules and on the effectiveness of internal control
over financial reporting as at December 31, 2009; and our
Managements Discussion and Analysis included as
Item 5. Operating and Financial Review
and Prospects in our annual report on
Form 20-F;
|
|
|
(b)
|
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;
|
|
|
(c)
|
our management information circular dated March 23, 2010 in
connection with our annual and special meeting of shareholders
held on May 13, 2010, which was included as
Exhibit 99.1 to our report on
Form 6-K
furnished to the SEC on March 31, 2010; and
|
|
|
(d)
|
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. Under the MJDS adopted by the
United States and Canada, these reports and other
information that we file with or furnish to the SEC may be
prepared in accordance with the disclosure requirements of
Canada, which differ in certain respects from those in the
United States. 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.
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.
2
DOCUMENTS
FILED AS PART OF THE REGISTRATION STATEMENT
The following documents have been filed with the SEC as part of
the registration statement of which this prospectus forms a
part: (1) the documents listed under the heading Documents
Incorporated by Reference; (2) powers of attorney from our
directors and officers; (3) the consent of
PricewaterhouseCoopers LLP; and (4) the consent of Ogilvy
Renault LLP.
CURRENCY
AND EXCHANGE RATES
All references to C$ 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-month period
|
|
|
Year ended December 31,
|
|
|
|
ended June 30, 2010
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
High
|
|
|
1.0778
|
|
|
|
1.3000
|
|
|
|
1.2969
|
|
|
|
1.1853
|
|
Low
|
|
|
0.9961
|
|
|
|
1.0292
|
|
|
|
0.9719
|
|
|
|
0.9170
|
|
Rate at end of period
|
|
|
1.0606
|
|
|
|
1.0466
|
|
|
|
1.2246
|
|
|
|
0.9881
|
|
Average rate per period
|
|
|
1.0338
|
|
|
|
1.1420
|
|
|
|
1.0660
|
|
|
|
1.0748
|
|
On July 14, 2010, the exchange rate for one U.S. dollar
expressed in Canadian dollars based upon the noon rate of the
Bank of Canada was C$1.0306.
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:
|
|
|
|
|
investments in biopharmaceutical companies are generally
considered to be speculative;
|
|
|
|
we may never achieve or maintain operating profitability;
|
|
|
|
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;
|
|
|
|
we may not be able to successfully complete our clinical trial
programs, or such clinical trials could take longer to complete
than we project;
|
|
|
|
the impact of the stringent ongoing government regulation to
which our product candidates are subject and future changes in
such regulatory environment;
|
|
|
|
we may not be able to generate significant revenues if our
products do not gain market acceptance;
|
|
|
|
we may require significant additional financing, and we may not
have access to sufficient capital;
|
|
|
|
we may cease to continue operating as we do if we are
unsuccessful in increasing our revenues and/or raising
additional funding;
|
|
|
|
failure to achieve our projected development goals in the
time-frames we announce and expect;
|
|
|
|
the impact of any failure on our part to obtain acceptable
prices or adequate reimbursement for our products on our ability
to generate revenues;
|
|
|
|
competition in our targeted markets;
|
|
|
|
we may not obtain adequate protection for our products through
our intellectual property;
|
|
|
|
we may infringe the intellectual property rights of others;
|
3
|
|
|
|
|
we may incur liabilities from our involvement in any patent
litigation;
|
|
|
|
we may not obtain trademark registrations in connection with our
product candidates;
|
|
|
|
we may not be able to make adequate arrangements with third
parties for the purpose of commercializing our product
candidates;
|
|
|
|
the failure to perform satisfactorily by third parties upon
which we rely to conduct, supervise and monitor our clinical
trials;
|
|
|
|
the failure to perform satisfactorily by third parties upon
which we rely to manufacture and supply products;
|
|
|
|
our ability to retain or attract key personnel;
|
|
|
|
our strategic partners manufacturing capabilities may not
be adequate to effectively commercialize our product candidates;
|
|
|
|
risks related to product liability claims;
|
|
|
|
the impact of legislative actions, new accounting pronouncements
and higher insurance costs on our future financial position or
results of operations;
|
|
|
|
fluctuations in currency exchange rates;
|
|
|
|
stock market volatility and the possibility that our Common
Shares may be delisted from the stock exchanges on which they
currently trade; and
|
|
|
|
the influence of our largest shareholders 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 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. 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
colorectal cancer, combined with our Phase 2 program in multiple
cancers, 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 our Phase 3 trial with
AEZS-130
(Soloreltm)
as a growth hormone (GH) stimulation test for the
diagnosis of GH deficiency in adults (AGHD).
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
4
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.
The following table summarizes the development status of our
principal products and product candidates:
Status of
our drug pipeline as at July 15, 2010
|
|
|
|
|
|
|
|
|
|
|
Discovery
|
|
Preclinical
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Commercial
|
|
120,000
compound
library
|
|
AEZS-120 Prostate cancer vaccine (oncology)
AEZS-129, 131 and 132 Erk & P13K Inhibitors (oncology)
AEZS-127 ErPC (oncology)
AEZS-123 Ghrelin receptor antagonist (endocrinology)
AEZS-115 Non-peptide LHRH antagonists (endocrinology and/or oncology)
|
|
AEZS-112 (oncology)
AEZS-130 Therapeutic in tumor induced cachexia and other (endocrinology)
|
|
Perifosine Multiple cancers
AEZS-108 Ovarian cancer
Endometrial cancer
|
|
Perifosine
Multiple myeloma
Colorectal
cancer
AEZS-130
(Soloreltm)
Diagnostic in adult growth
hormone deficiency (endocrinology)
|
|
Cetrotide®
(in vitro fertilization)
|
|
|
|
|
|
|
|
|
|
|
|
|
Partners
|
|
|
|
|
|
Perifosine: Keryx North America
Handok Korea (oncology)
|
|
Perifosine: Keryx North America
Handok Korea (oncology)
|
|
Cetrotide®: Merck Serono (World ex-Japan)
Nippon Kayaku / Shionogi 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
programs in multiple myeloma and refractory advanced colorectal
cancer and Phase 2 program in multiple cancers, 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.
5
Perifosine
Perifosine is an orally active PI3K/Akt pathway inhibitor in two
Phase 3 registration trials, one in multiple myeloma and the
other in refractory advanced colorectal cancer, each of which is
conducted and sponsored by our North American partner Keryx
Biopharmaceuticals, Inc. (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 status in multiple
myeloma and Fast Track designations in both indications.
Perifosine has also been granted orphan medicinal product
designation from the European Medicines Agency (EMA)
in multiple myeloma. In addition, perifosine has received
positive advice from the EMA for both multiple myeloma and
colorectal cancer programs and has been granted by the FDA
orphan-drug designation for the treatment of neuroblastoma. See
Recent Developments. Perifosine is also
in current multiple Phase 1 and 2 clinical
studies, including renal cell cancer, pediatric cancer and
various other cancers.
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 luteinizing hormone releasing hormone
(LHRH)-receptor
positive tumors. Phase 2 trials in advanced endometrial cancer
and advanced ovarian cancer have met their predefined primary
efficacy endpoints.
We have obtained orphan-drug status for
AEZS-108 in
advanced ovarian cancer from the FDA and from the Committee for
Orphan Medicinal Products of the EMA, and the FDA has approved
our Investigational New Drug (IND) application for
AEZS-108 in
urothelial (bladder) cancer. Having received IND approval,
we expect to initiate a Phase 2 trial in this indication in the
second half of 2010. See Recent
Developments.
Endocrinology
In endocrinology, aside from
Cetrotide®,
we intend to further advance the development of our lead program
by the reactivation and further advancement of a Phase 3 trial
with
AEZS-130
(Soloreltm)
as a GH stimulation test for the diagnosis of AGHD.
AEZS-130
(macimorelin)
AEZS-130
(macimorelin), a growth hormone secretagogue, 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 U.S. 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
(Soloreltm),
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
AEZS-112, an
oral anticancer agent which involves three mechanisms of action
(tubulin and topoisomeras II and angiogenesic inhibition) in
Phase 1, 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,
AEZS-131 and
AEZS-132
(Erk and PI3K inhibitors),
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.
6
Recent
Developments
Perifosine
On May 17, 2010, we announced the publication of an article
in the May 12, 2010 edition of the Journal of the National
Cancer Institute entitled In Vitro and In Vivo
Inhibition of Neuroblastoma Tumor Cell Growth by AKT Inhibitor
Perifosine, demonstrating the single agent activity of
perifosine in neuroblastoma tumor preclinical models.
Neuroblastoma is the most common pediatric solid tumor.
Perifosine, our novel, potentially
first-in-class,
oral anti-cancer agent that inhibits Akt activation in the
phosphoinositide
3-kinase
(PI3K) pathway, is currently being investigated in a Phase 1
study as a single agent treatment for recurrent solid tumors,
including neuroblastoma, in pediatric patients. The article
states that activated Akt is a marker of decreased event-free or
overall survival in neuroblastoma patients, and that the aim of
this study was to investigate the effect of perifosine, an Akt
inhibitor, as a single agent on neuroblastoma cell growth in
vitro and in vivo. The preclinical study investigated
the activity of perifosine on four human neuroblastoma cell
lines, as well as on the survival, tumor growth, and activation
status of Akt in mice bearing human neuroblastoma xenograft
tumors. Perifosine showed a statistically significant reduction
in neuroblastoma cell survival, slowed or regressed tumor
growth, and increased survival in mice bearing neuroblastoma
tumors. A decreased level of activated Akt was also observed in
perifosine-treated neuroblastoma cells and xenograft tumors. The
investigators concluded that perifosine inhibited the activation
of Akt and was an effective cytotoxic agent in neuroblastoma
cells in vitro and in vivo, and that this data
supports the future clinical evaluation of perifosine for the
treatment of neuroblastoma tumors.
On June 7, 2010, we announced that Phase 1 data of
perifosine in recurrent pediatric solid tumors was presented in
the pediatric solid tumor poster discussion session held at the
46th annual meeting of the American Society of Clinical Oncology
(ASCO) taking place in Chicago. This study,
conducted by the Memorial Sloan-Kettering Cancer Center
pediatric group, marks the first time that perifosine has been
administered in a pediatric patient setting.
This Phase 1 Study of perifosine for Recurrent Pediatric Solid
Tumors is a single center, open-label, dose-escalating study to
assess safety, tolerability, pharmacokinetics (PK),
and to identify any dose limiting toxicity (DLT) of
single agent perifosine in pediatric patients with any solid
tumor that has failed standard therapy. Eleven patients (4
males, 7 females), at a median age of 13 years (5-18)
were treated in this study to date. The following tumor types
were treated thus far:
high-grade
glioma (5), medulloblastoma (2), neuroblastoma (3), and
ependymoma (1). Most patients were heavily pretreated, with a
median of three prior lines of therapy. Cohorts of three
patients were treated at three dose levels:
25mg/m2/day,
50mg/m2/day
and
75mg/m2/day
using 50mg tablets of perifosine after a loading dose on
day 1, and taking into account the drugs long
half-life
(>100hrs). No DLTs were observed at any of the three
dose levels; dose level 4 is currently open for accrual. PK
data thus far suggests similar drug absorption by pediatric
patients relative to adult patients treated with single agent
perifosine.
Of particular interest are the early signs of clinical activity
observed in two of the three patients with Stage 4
refractory neuroblastoma. Both patients were refractory to prior
treatments upon entering the study and achieved stable disease
for 48 weeks and 55+ weeks (ongoing). The
investigators concluded that perifosine is well-tolerated in
children with recurrent solid tumors and that these early
signals of activity warrant further investigation in patients
with advanced neuroblastoma and select brain tumors. Previously,
perifosine has been shown to target activation of Akt in
neuroblastoma cells and xenografts and to significantly inhibit
tumor growth in vivo and improve the survival of mice
bearing neuroblastoma tumors.
On June 29, 2010, we announced that we had received
positive Scientific Advice from the EMA regarding the
Phase 3 trial for the development of perifosine in
refractory advanced colorectal cancer. The Scientific Advice
from the EMA indicates that the ongoing study, in conjunction
with safety data generated from other clinical studies with
perifosine, is considered sufficient to provide all data
necessary to support a marketing authorization of perifosine in
advanced colorectal cancer and we do not intend to initiate any
additional study with perifosine for this indication. Last
April, we had also received positive Scientific Advice from the
EMA for the ongoing Phase 3 trial in multiple myeloma with
perifosine, being conducted by Keryx in the U.S. Therefore, for
the development of perifosine in both these indications, we
believe that the planned North American clinical program, which
is sponsored by our partner Keryx, is now sufficient for
approval in Europe and in many countries in the rest of the
world, where we hold rights for our compound.
Furthermore, we announced on July 14, 2010 that our partner
Keryx had been granted orphan-drug designation by the FDA for
perifosine for the treatment of neuroblastoma, a cancer of the
nervous system affecting mostly children and infants for which
there are no FDA approved therapies. We believe that the
orphan-drug designation in neuroblastoma is another important
milestone in the development of perifosine as a novel approach
to treating cancer patients, particularly in this area of unmet
medical need.
7
AEZS-108
On May 6, 2010, we announced that we had received
orphan-drug designation from the FDA for
AEZS-108,
our doxorubicin targeted conjugate compound, for the treatment
of ovarian cancer.
AEZS-108 is
currently in a Phase 2 trial in advanced ovarian and advanced
endometrial cancer in Europe. Orphan-drug designation is granted
by the FDA Office of Orphan Products Development to novel drugs
or biologics that treat a rare disease or condition affecting
fewer than 200,000 patients in the U.S. The designation provides
a drug developer with a seven-year period of marketing
exclusivity if the drug is the first of its type approved for
the specified indication or if it demonstrates superior safety,
efficacy or a major contribution to patient care versus another
drug of its type previously granted the designation for the same
indication.
On May 12, 2010, we announced that the FDA had approved our
IND application for
AEZS-108 in
LHRH-receptor
positive urothelial (bladder) cancer. Following this approval
from the FDA, we expect to initiate a Phase 2 clinical
trial in this indication in the second half of 2010. This trial
will be conducted at the Sylvester Comprehensive Cancer Center
at the University of Miami Miller School of Medicine, and will
include up to 64 patients, male and female, with advanced
LHRH-receptor
positive urothelial (bladder) cancer. The study will be
conducted in two parts: first, a
dose-finding
part in up to 12 patients; subsequently, a selected dose
will be studied for its effect on
progression-free
survival.
On May 17, 2010, we also announced that we had received a
positive opinion for orphan medicinal product designation from
the Committee for Orphan Medicinal Products (COMP)
of the EMA for
AEZS-108 for
the treatment of ovarian cancer. Orphan medicinal product
designation is granted by the European Commission, following a
positive opinion from the COMP, to a medicinal product that is
intended for the diagnosis, prevention or treatment of a
life-threatening
or a chronically debilitating condition affecting not more than
five in 10,000 persons in the European Community when the
application for designation is submitted. Orphan medicinal
product designation provides the sponsor with access to a
centralized procedure for the application for marketing
authorization, protocol assistance, up to a 100% reduction in
fees related to a marketing authorization application,
pre-authorization
inspection and post-authorization activities, and could provide
ten years of market exclusivity in the European Union for
AEZ-108 once
approved for the treatment of ovarian cancer.
On June 7, 2010, Prof. Günter Emons, Chairman,
Department of Obstetrics & Gynaecology Georg-August
University Göttingen, Germany, presented positive efficacy
and safety data for
AEZS-108, in
ovarian cancer, at the ASCO annual meeting.
AEZS-108 is
currently in a Phase 2 trial conducted in Europe by the German
AGO Study Group (Study AGO-GYN5), in advanced ovarian and
endometrial cancer, with final results expected by year-end. The
poster (abstract #5035) entitled, Phase 2 study of
AEZS-108, a
targeted cytotoxic LHRH analog, in patients with
LHRH-receptor
positive platinum resistant ovarian cancer, G. Emons, S.
Tomov, P. Harter, J. Sehouli, P. Wimberger, A. Staehle, L. C.
Hanker, F. Hilpert, P. Dall, and C. Gruendker, for the AGO
Study Group, details the use of
AEZS-108, a
targeted cytotoxic drug in which doxorubicin is linked to
[D-Lys(6)]-LHRH in women with histologically confirmed
taxane-pretreated platinum-resistant/refractory
LHRH-receptor
positive advanced (FIGO III or IV) or recurrent ovarian
cancer. Patients received a recommended dose of
267 mg/m2
by intravenous infusion over 2 hours, with retreatment
every 3 weeks, for up to 6 courses. Response rate
(RECIST and/or GCIG criteria) was defined as primary endpoint.
Secondary endpoints were safety,
time-to-progression
and overall survival.
Forty-two patients with platinum-resistant ovarian cancer
entered the study. Efficacy included partial response in
5 patients (11.9%) and stable disease for more than
12 weeks in 11 patients (26.2%). Based on those data,
a Clinical Benefit Rate (CBR) of 38% can be estimated. Median
time to progression and overall survival were 3.5 months
(104 days) and 15.6 months (475 days),
respectively.
In all, tolerability of
AEZS-108 was
good and commonly allowed retreatment as scheduled. Only one
patient (2.4%) had a dose reduction, and overall, 25 of 170
(14.7%) courses were given with a delay, including also cases in
which delay was not related to toxicity. Severe (Grade 3
or 4) toxicity was mainly restricted to rapidly reversible
hematologic toxicity (leukopenia / neutropenia) associated
with fever in 3 cases. Good tolerability of
AEZS-108 was
also reflected with only a few patients with non-hematological
toxicities of grade 3 (none with grade 4), including
single cases (2.4%) each of nausea, constipation, poor general
condition, and an enzyme elevation. No cardiac toxicity was
reported.
On June 28, 2010, we announced that we had concluded a
collaborative study with Almacs Diagnostics division for
AEZS-108,
aimed at determining LHRH-receptor expression through the
development of a companion diagnostic tool. Selection for
treatment with
AEZS-108 is
determined on the basis of LHRH-receptor expression, currently
measured immunohistochemically. In humans, LHRH receptors are
expressed in ovarian, endometrial, breast, bladder, prostate and
pancreatic tumors. This state of the art companion diagnostic
tool will allow us to develop improved methods of selecting the
most appropriate patients to be treated with
AEZS-108 in
order to enhance the efficiency of our clinical trials and help
us with the future successful development of
AEZS-108 in
a number of different LHRH expressing cancers.
8
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, 2009 (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 March 31, 2010
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-month periods ended
March 31, 2010 and 2009, we had an accumulated deficit of
U.S.$133.4 million as of March 31, 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
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
9
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, 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:
|
|
|
|
|
must meet the requirements of these authorities;
|
|
|
|
must meet requirements for informed consent; and
|
|
|
|
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 of physicians, the existence of competitive clinical
trials, and
10
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:
|
|
|
|
|
demonstration of clinical efficacy and safety;
|
|
|
|
the prevalence and severity of any adverse side effects;
|
|
|
|
limitations or warnings contained in the products approved
labeling;
|
|
|
|
availability of alternative treatments for the indications we
target;
|
|
|
|
the advantages and disadvantages of our products relative to
current or alternative treatments;
|
11
|
|
|
|
|
the availability of acceptable pricing and adequate third-party
reimbursement; and
|
|
|
|
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:
|
|
|
|
|
the duration and results of our clinical trials for our various
product candidates going forward;
|
|
|
|
unexpected delays or developments in seeking regulatory
approvals;
|
|
|
|
the time and cost involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims;
|
|
|
|
other unexpected developments encountered in implementing our
business development and commercialization strategies;
|
|
|
|
the outcome of litigation, if any; and
|
|
|
|
further arrangements, if any, with collaborators.
|
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.
A
substantial portion of our future revenues may be dependent upon
our agreement with Keryx.
We currently expect that a substantial portion of our future
revenues may be dependent upon our strategic partnership with
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,
12
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 of and for the three-month periods ended March 31, 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 of and for the three-month periods ended
March 31, 2010 and 2009 that management believed that the
Company had, as at March 31, 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 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 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.
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
13
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
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
14
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 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
15
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:
|
|
|
|
|
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;
|
|
|
|
the timing of regulatory submissions and approvals;
|
|
|
|
the timing and willingness of any current or future
collaborators to invest the resources necessary to commercialize
our product candidates;
|
|
|
|
the revenue available from royalties derived from our strategic
partners;
|
|
|
|
licensing fees revenues;
|
|
|
|
tax credits and grants (R&D);
|
|
|
|
the outcome of litigation, if any;
|
|
|
|
changes in foreign currency fluctuations;
|
|
|
|
the timing of achievement and the receipt of milestone payments
from current or future collaborators; and
|
|
|
|
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.
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
16
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:
|
|
|
|
|
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;
|
|
|
|
our strategic partners may under-fund or fail to commit
sufficient resources to marketing, distribution or other
development of our products;
|
|
|
|
we may not be able to renew such agreements;
|
|
|
|
our strategic partners may not properly maintain or defend
certain intellectual property rights that may be important to
the commercialization of our products;
|
|
|
|
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);
|
|
|
|
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
|
|
|
|
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.
|
17
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, 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
(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 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
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
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.
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,
18
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.
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
19
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 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 2009 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 2010 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, for 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.
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
20
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.
Additional information on our conversion to IFRS is provided in
our Managements Discussion and Analysis for the
three-month period ended March 31, 2010 and 2009, which is
incorporated by reference into this 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 Securities
Our
share price is volatile, which may result from factors outside
of our control. If our Common Shares are delisted from the TSX
or NASDAQ, investors may have difficulty in disposing of our
Common Shares held by them.
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 C$0.57 to C$3.11 per share
on the TSX, and from $0.46 to $2.83 on the NASDAQ, and during
the six months ended June 30, 2010, the closing price of
our Common Shares ranged from C$0.80 to C$2.14 per share on
the TSX and from $0.79 to $2.09 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
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:
|
|
|
|
|
clinical and regulatory developments regarding our product
candidates;
|
|
|
|
delays in our anticipated development or commercialization
timelines;
|
|
|
|
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
21
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 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 U.S.$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.
Two of
our 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.
Two of our most significant shareholders 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.
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.
22
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 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 July 14, 2010,
there were:
|
|
|
|
|
83,138,663 Common Shares issued and outstanding;
|
|
|
|
No issued and outstanding Preferred Shares (as defined below);
|
|
|
|
13,105,540 Common Shares issuable upon exercise of outstanding
warrants; and
|
|
|
|
6,202,355 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 March 31, 2010, there has been no material change in
our loan and capital structure on a consolidated basis, except
for (i) the issuance of Common Shares and warrants to
purchase Common Shares, as described in Note 10 to our
unaudited interim consolidated financial statements as at and
for the three-month periods ended March 31, 2010 and 2009,
which financial statements are incorporated by reference into
this Prospectus, pursuant to which the Company received proceeds
of U.S.$15.0 million, less cash transaction costs of
approximately U.S.$1.3 million and (ii) the issuance
of
23
8,805,964 units, each unit being comprised of one Common Share
and one warrant to purchase 0.50 of a Common Share, pursuant to
a registered direct offering completed on June 21, 2010 by
way of supplement to our short form base shelf prospectus dated
March 12, 2010, pursuant to which the Company received
proceeds of U.S.$12.0 million, less cash transaction costs
of approximately U.S.$0.7 million
As of March 31, 2010, 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
July 14, 2010, there were 83,138,663 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
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, 2009 (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.
24
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.
We will not offer Warrants or other convertible or exchangeable
securities for sale separately (as opposed to as part of a unit
offering) to any member of the public in Canada unless the
offering is in connection with and forms part of the
consideration for an acquisition or merger transaction or unless
a Prospectus Supplement containing the specific terms of the
Warrants or other convertible or exchangeable securities to be
offered separately is first approved for filing by the
Autorité des marchés financiers on behalf of
the securities commissions or similar securities regulatory
authorities in each of the provinces of Canada where the
Warrants will be offered for sale.
25
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 the
monthly range of high and low closing prices of a Common Share
and the average daily volumes per month traded on NASDAQ and on
the TSX during the period beginning on July 1, 2009 and
ending on July 14, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NASDAQ (U.S.$)
|
|
|
TSX (C$)
|
|
|
|
High
|
|
|
Low
|
|
|
Volume
|
|
|
High
|
|
|
Low
|
|
|
Volume
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July
|
|
|
2.62
|
|
|
|
1.67
|
|
|
|
391,576
|
|
|
|
2.80
|
|
|
|
1.95
|
|
|
|
188,891
|
|
August
|
|
|
2.83
|
|
|
|
0.89
|
|
|
|
1,567,974
|
|
|
|
3.11
|
|
|
|
0.97
|
|
|
|
704,210
|
|
September
|
|
|
1.38
|
|
|
|
0.89
|
|
|
|
1,240,716
|
|
|
|
1.46
|
|
|
|
0.98
|
|
|
|
259,348
|
|
October
|
|
|
1.25
|
|
|
|
0.99
|
|
|
|
408,270
|
|
|
|
1.40
|
|
|
|
1.07
|
|
|
|
96,648
|
|
November
|
|
|
1.10
|
|
|
|
0.98
|
|
|
|
191,089
|
|
|
|
1.17
|
|
|
|
1.05
|
|
|
|
97,410
|
|
December
|
|
|
1.12
|
|
|
|
0.80
|
|
|
|
341,716
|
|
|
|
1.17
|
|
|
|
0.83
|
|
|
|
140,062
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January
|
|
|
0.93
|
|
|
|
0.80
|
|
|
|
489,389
|
|
|
|
0.99
|
|
|
|
0.83
|
|
|
|
109,245
|
|
February
|
|
|
0.87
|
|
|
|
0.81
|
|
|
|
102,265
|
|
|
|
0.91
|
|
|
|
0.86
|
|
|
|
38,021
|
|
March
|
|
|
0.85
|
|
|
|
0.79
|
|
|
|
217,325
|
|
|
|
0.87
|
|
|
|
0.81
|
|
|
|
77,730
|
|
April
|
|
|
1.65
|
|
|
|
0.80
|
|
|
|
4,816,695
|
|
|
|
1.66
|
|
|
|
0.80
|
|
|
|
877,252
|
|
May
|
|
|
2.09
|
|
|
|
1.21
|
|
|
|
7,920,920
|
|
|
|
2.14
|
|
|
|
1.23
|
|
|
|
884,790
|
|
June
|
|
|
1.78
|
|
|
|
1.12
|
|
|
|
2,538,998
|
|
|
|
1.88
|
|
|
|
1.15
|
|
|
|
266,000
|
|
July(1)
|
|
|
1.19
|
|
|
|
1.02
|
|
|
|
1,710,376
|
|
|
|
1.24
|
|
|
|
1.08
|
|
|
|
144,622
|
|
|
|
(1) |
Up to and including July 14, 2010.
|
PRIOR
SALES
On June 23, 2009, we completed a registered direct offering
by way of supplement to our short form base shelf prospectus
dated September 27, 2007, 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 under this prospectus
supplement 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 registered
direct offering by way of supplement to our short form base
shelf prospectus dated September 27, 2007, 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 under this prospectus supplement 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
C$0.95 to certain directors, executive officers and employees of
the Company pursuant to our stock option plan.
On April 20, 2010, we completed a registered direct
offering by way of supplement to our short form base shelf
prospectus dated March 12, 2010, 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 U.S.$1.35 per unit. Each such warrant has an exercise
price of U.S.$1.50 per share.
Furthermore, on June 21, 2010, we completed a registered
direct offering by way of supplement to our short form base
shelf prospectus dated March 12, 2010, 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 U.S.$1.3725 per unit. Each such warrant has an
exercise price of U.S.$1.3725 per share. We also issued
under this prospectus supplement 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 this
offering, which warrants have an exercise price of
U.S.$1.7156 per share.
26
SELLING
SECURITYHOLDERS
Securities may be sold under this Prospectus by way of secondary
offering by certain holders or purchasers of the Securities. The
Prospectus Supplement for or including any offering of
Securities by selling securityholders will include the following
information:
|
|
|
|
|
the names of the selling securityholders;
|
|
|
|
the number of Securities owned by each of the selling
securityholders;
|
|
|
|
the number of Securities being distributed for the accounts of
the selling securityholders;
|
|
|
|
the number of the Securities of any class to be owned by the
selling securityholders after the distribution and
the percentage that number represents of the total number
of Securities of that class outstanding;
|
|
|
|
whether the Securities are owned by the selling securityholder
both of record and beneficially, of record only, or beneficially
only;
|
|
|
|
the date or dates the selling securityholder acquired the
Securities; and
|
|
|
|
if the selling securityholder acquired any Securities in the
twelve months preceding the date of this Prospectus, the cost
thereof to the securityholder in the aggregate and on a per
security basis.
|
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.
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, including sales in
transactions that are deemed to be at the market
distributions under applicable securities laws. 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.
27
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.
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. 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
applicable 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.
AUDITORS
Our auditors are PricewaterhouseCoopers LLP, who have issued an
audit opinion dated March 23, 2010 in respect of our
consolidated balance sheets as at December 31, 2009 and
2008 and our 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, our financial statement schedules and
the effectiveness of our internal control over financial
reporting as of December 31, 2009. PricewaterhouseCoopers
LLP has advised that they are independent within the meaning of
the Rules of Professional Conduct of the Ordre des comptables
agréés du Québec.
28
PART II
INFORMATION NOT REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
Indemnification of Directors and Officers
Under Section 124 of the Canada Business Corporations Act, the Registrant may indemnify a
present or former director or officer of the Registrant or another individual who acts or acted at
the Registrants request as a director or officer, or an individual acting in a similar capacity,
of another entity, against all costs, charges and expenses, including an amount paid to settle an
action or satisfy a judgment, reasonably incurred by the individual in respect of any civil,
criminal, administrative, investigative or other proceeding in which the individual is involved
because of that association with the Registrant or other entity. The Registrant may not indemnify
an individual unless the individual (i) acted honestly and in good faith with a view to the best
interests of the Registrant or, as the case may be, to the best interests of the other entity for
which the individual acted as director or officer or in a similar capacity at the Registrants
request, and (ii) in the case of a criminal or administrative action or proceeding that is enforced
by a monetary penalty, had reasonable grounds for believing that his or her conduct was lawful.
Such indemnification may be made in connection with an action by or on behalf of the Registrant or
other entity to procure a judgment in its favor only with court approval. A director or officer is
entitled to indemnification from the Registrant as a matter of right if he or she was not judged by
the Court or other competent authority to have committed any fault or omitted to do anything that
he or she ought to have done and fulfilled the conditions set forth above. The Registrant may
advance moneys to a director, officer or other individual for the costs, charges and expenses of a
proceeding referred to above. The individual shall repay the moneys if he or she does not fulfill
the conditions set forth above to qualify for indemnification.
In accordance with provisions of the Canada Business Corporations Act described above, the
by-laws of the Registrant provide that the Registrant shall indemnify a director or officer of the
Registrant, a former director or officer of the Registrant or a person who acts or acted at the
Registrants request as a director or officer of a body corporate of which the Registrant is or was
a shareholder or creditor, and his or her heirs and legal representatives, against all costs,
losses, charges and expenses, including an amount paid to settle an action or satisfy a judgment,
reasonably incurred by such person in respect of any civil, criminal or administrative action or
proceeding to which such person is made a party by reason of being or having been a director or
officer of the Registrant or such body corporate, if: (a) the person acted honestly and in good
faith with a view to the best interests of the Registrant and (b) in the case of criminal or
administrative action or proceeding that is enforced by a monetary penalty, the person had
reasonable grounds for believing that their conduct was lawful. The Registrant may indemnify from
time to time any director or other person who has assumed or is about to assume in the normal
course of business any liability for the Registrant or for any corporation controlled by the
Registrant, and to secure such director or other person against any loss by the pledge of all or
part of the movable or immovable property of the Registrant through the creation of a hypothec or
any other real right in all or part of such property or in any other manner.
The by-laws of the Registrant also provide that the Registrant may, to the extent permitted by
the Canada Business Corporations Act, purchase and maintain insurance for the benefit of any person
referred to above against any such liability as the board of directors may from time to time
determine.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers or persons controlling the Registrant pursuant to the foregoing
provisions, the Registrant has been informed that in the opinion of the U.S. Securities and
Exchange Commission such indemnification is against public policy as expressed in the Securities
Act and is therefore unenforceable.
Exhibits
See
Exhibit Index following the signature pages of this Amendment
No. 1 to the Registration Statement.
II-1
PART III
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
Item 1. Undertaking
The Registrant undertakes to make available, in person or by telephone, representatives to
respond to inquiries made by the Commission staff, and to furnish promptly, when requested to do so
by the Commission staff, information relating to the securities registered pursuant to Form F-10 or
to transactions in said securities.
Item 2. Consent to Service of Process
The
Registrant has previously filed with
the Commission a written irrevocable consent and power of attorney on Form F-X.
Any change to the name or address of the agent for service of the Registrant shall be
communicated promptly to the Commission by amendment to Form F-X referencing the file number of
this Registration Statement.
III-1
SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant certifies that it has
reasonable grounds to believe that it meets all of the requirements for filing and has duly caused
this Amendment No. 1 to the Registration Statement on Form F-10 to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Quebec, Province of Quebec, Canada,
on July 15, 2010.
|
|
|
|
|
|
ÆTERNA ZENTARIS INC.
|
|
|
By: |
/s/ Dennis Turpin
|
|
|
|
Name: |
Dennis Turpin |
|
|
|
Title: |
Senior Vice President and
Chief Financial Officer |
|
|
Pursuant to the requirements of the Securities Act, this Amendment No. 1 to the Registration Statement on Form F-10
has been signed by the following persons in the capacities indicated
below on July 15, 2010.
|
|
|
Signature |
|
Title |
|
|
|
|
|
President and Chief Executive Officer and Director
(Principal Executive Officer) |
|
|
|
/s/
Dennis Turpin
Dennis Turpin
|
|
Senior Vice President and Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer) |
|
|
|
|
|
Senior Vice President, Administration and Legal Affairs |
|
|
|
|
|
Director and Chairman of the Board |
|
|
|
Signature |
|
Title |
|
|
|
|
|
Director |
|
|
|
|
|
Director |
|
|
|
|
|
Director |
|
|
|
|
|
Director |
|
|
|
|
|
Director |
|
|
|
|
|
*By: |
/s/ Dennis Turpin
|
|
|
|
|
Dennis Turpin
Attorney-in-Fact |
|
|
|
|
AUTHORIZED REPRESENTATIVE
Pursuant to the requirements of Section 6(a) of the Securities Act of 1933, the undersigned
has signed this Amendment No. 1 to the Registration Statement on Form F-10, solely in the capacity of the duly authorized
representative of Æterna Zentaris Inc. in the United States, on
July 15, 2010.
|
|
|
|
|
|
ÆTERNA ZENTARIS, INC.
|
|
|
By: |
/s/ Dennis Turpin
|
|
|
|
Name: |
Dennis Turpin |
|
|
|
Title: |
Authorized Signatory |
|
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
4.1
|
|
Annual Report on Form 20-F for the financial year ended December 31, 2009 (filed in Canada
with the Canadian securities regulatory authorities in lieu of an annual information form)
(filed with the SEC on March 30, 2010). |
|
|
|
4.2
|
|
Consolidated balance sheets of Æterna Zentaris Inc. as at December 31, 2009 and 2008
and 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 and the financial statement
schedules and managements annual report on internal control over financial reporting set out
on page 116 of Æterna Zentaris Inc.s Annual Report on Form 20-F, together with the report
dated March 23, 2010 of Æterna Zentaris Inc.s independent auditors,
PricewaterhouseCoopers LLP, on Æterna Zentaris Inc.s consolidated financial statements and on
the effectiveness of internal control over financial reporting as at
December 31, 2009 as filed with the Canadian
securities regulatory authorities on March 25, 2010 (included as Exhibit 99.2 of Æterna
Zentaris Inc.s Report on Form 6-K furnished to the SEC on March 25, 2010). |
|
|
|
4.3
|
|
Managements Discussion and Analysis for the financial year ended December 31, 2009, as filed
with the Canadian securities regulatory authorities on March 25, 2010 (included as Exhibit
99.1 of Æterna Zentaris Inc.s Report on Form 6-K furnished to the SEC on March 25, 2010). |
|
|
|
4.4
|
|
Management Information Circular dated March 23, 2010 in connection with Æterna Zentaris
Inc.s annual and special meeting of shareholders held on May 13, 2010 (included as Exhibit
99.1 to Æterna Zentaris Inc.s Report on Form 6-K furnished to the SEC on March 31, 2010). |
|
|
|
4.5
|
|
Unaudited interim consolidated financial statements of Æterna Zentaris Inc. as of March 31,
2010 and for the three-month periods ended March 31, 2010 and 2009 (included as Exhibit 99.1
to Æterna Zentaris Inc.s Report on Form 6-K furnished to the SEC on May 13, 2010). |
|
|
|
4.6
|
|
Managements Discussion and Analysis for the three-month period ended March 31, 2010
(included as Exhibit 99.1 to Æterna Zentaris Inc.s Report on Form 6-K furnished to the SEC on
May 13, 2010). |
|
|
|
5.1*
|
|
Consent of PricewaterhouseCoopers LLP. |
|
|
|
5.2*
|
|
Consent of Ogilvy Renault LLP. |
|
|
|
6.1**
|
|
Powers of Attorney. |
|
|
|
* |
|
Filed herewith. |
|
** |
|
Previously filed. |