All amounts are in US Dollars
Highlights
Company reported on May 1 that ZoptEC Phase 3 clinical study
of ZoptrexTM (zoptarelin doxorubicin) did not achieve
its primary endpoint; further development of product to be
discontinued
Company announced on March 30 that, following its meeting
with the FDA it intends to file a new drug application seeking
approval of MacrilenTM (macimorelin) for the
evaluation of growth hormone deficiency in adults
Adequate liquidity and resources to fund operations through
expected Macrilen™ approval
- $17.8 million of unrestricted cash and
cash equivalents at quarter-end; no third-party debt
- Approximately $4.3 million of gross
proceeds raised from sales of Common Shares pursuant to ATM
programs during and subsequent to the first quarter
- Approximately 14.3 million Common
Shares outstanding as of May 8
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the
“Company”), a specialty biopharmaceutical company engaged in
developing and commercializing novel pharmaceutical therapies,
today reported financial and operating results for the first
quarter ended March 31, 2017.
Commenting on recent key developments, David A. Dodd, President
and Chief Executive Officer of the Company, stated, “On May 1, we
reported that the ZoptEC (zoptarelin doxorubicin in endometrial
cancer) Phase 3 study of Zoptrex™ in women with locally advanced,
recurrent or metastatic endometrial cancer did not achieve its
primary endpoint of demonstrating a statistically significant
increase in the median period of overall survival of patients
treated with Zoptrex™ as compared to patients treated with
doxorubicin. Therefore, the results of the study do not support
regulatory approval of Zoptrex™. Based on this outcome, we do not
anticipate conducting clinical trials of Zoptrex™ with respect to
any other indications.” Regarding the Company’s plans, Mr. Dodd
continued, “Our focus has now shifted entirely to filing our new
drug application (“NDA”) for Macrilen™ and, if the product is
approved, to its commercial launch as soon as possible. We will
also optimize our resources to be consistent with our focus on
Macrilen™-related efforts. Consequently, we now expect that our
monthly average use of cash in operations during the remainder of
2017 will be between $1.7 million and $1.9 million, a decrease of
approximately 22%, compared to the first quarter. We continue to
believe in the potential that Macrilen™ provides for us to become a
successful specialty pharmaceutical company. Our intention is to
submit the Macrilen™ NDA in the third quarter of 2017 and, if the
product receives approval from the U.S. Food and Drug
Administration (the “FDA”), to commercially launching the product
in the first quarter of 2018.”
First Quarter Financial Highlights
Revenues
Revenues were $261,000 for the three months ended March 31,
2017, as compared to $242,000 for the same period in 2016. The
increase is mainly explained by the amortization of the up-front
payment received in connection with one of the out-licensing
agreements that we entered into in 2016 for ZoptrexTM with respect
to a territory outside our core areas of interest.
Research and Development (“R&D”) costs
R&D costs were $2.5 million for the three months ended March
31, 2017, compared to $3.7 million for the same period in 2016. The
decrease in our R&D costs for the three months ended March 31,
2017, as compared to the same period in 2016, is mainly
attributable to lower third-party costs attributable to Zoptrex™,
which is mainly due to the fact that we completed the clinical
portion of the ZoptEC clinical trial during the first quarter of
2017. Third-party costs attributable to Macrilen™ remained stable
during the three months ended March 31, 2017, as compared to the
same period in 2016.
General and Administrative (“G&A”) Expenses
G&A expenses were $1.9 million for both three-month periods
ended March 31, 2017 and 2016. The G&A expenses remained stable
and were in line with our expectations for the first quarter.
Selling Expenses
Selling expenses were $1.5 million for the three months ended
March 31, 2017, as compared to $1.7 million for the same period in
2016. Selling expenses for the three months ended March 31, 2017
and 2016 represent mainly the costs of our sales force related to
the co-promotion activities as well as our sales management team.
The decrease in selling expenses is explained by the reduction in
the number of sales representatives from 20 to 13 in February
2017.
Net Finance Income
Net finance income was $1.5 million for the three months ended
March 31, 2017, as compared to $3.3 million, for the same period in
2016. The decrease in finance income is mainly attributable to the
change in fair value recorded in connection with our warrant
liability. Such change in fair value results from the periodic
"mark-to-market" revaluation, via the application of option pricing
models, of outstanding share purchase warrants. The closing price
of our common shares, which, on the NASDAQ, fluctuated from $2.45
to $3.65 during the three-month period ended March 31, 2017,
compared to $2.67 to $4.40 during the same period in 2016, also had
a direct impact on the change in fair value of warrant
liability.
Net Loss
Net loss for the three months ended March 31, 2017 was $(4.1)
million, or $(0.31) per basic and diluted share, as compared to a
net loss of $(3.7) million, or $(0.37) per basic and diluted share,
for the same period in 2016. The increase in net loss for the three
months ended March 31, 2017, as compared to the same period in
2016, is largely attributable to lower operating expenses offset by
lower net finance income, as described above. The basic and diluted
loss per share decreased because the number of shares outstanding
increased following an offering completed in November 2016 as well
as issuances under our various ATM programs.
Liquidity
Cash and cash equivalents were $17.8 million as at March 31,
2017, as compared to $22.0 million as at December 31, 2016. The
decrease in cash and cash equivalents as at March 31, 2017, as
compared to December 31, 2016, is due to the net cash used in
operating activities and variations in components of our working
capital. The decrease was partially offset by the net proceeds
generated by the issuance of common shares under our various ATM
programs.
Conference Call & Webcast
The Company will host a conference call and live webcast to
discuss these results on Tuesday, May 9, 2017, at 8:30 a.m.,
Eastern Time. Participants may access the live webcast via the
Company's website at www.aezsinc.com
or by telephone using the following dial-in number: 201-689-8029
and Confirmation number 13658332. A replay of the webcast will also
be available on the Company’s website for a period of 30 days.
For reference, the Management’s Discussion and Analysis of
Financial Condition and Results of Operations for the first quarter
ended March 31, 2017, as well as the Company’s interim condensed
consolidated financial statements as at March 31, 2017, can be
found at www.aezsinc.com in the
“Investors” section.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel pharmaceutical
therapies. We are engaged in drug development activities and in the
promotion of products for others. We recently completed Phase 3
studies of two internally developed compounds. The focus of our
business development efforts is the acquisition of licenses to
products that are relevant to our therapeutic areas of focus. We
also intend to license out certain commercial rights of internally
developed products to licensees in non-U.S. territories where such
out-licensing would enable us to ensure development, registration
and launch of our product candidates. Our goal is to become a
growth-oriented specialty biopharmaceutical company by pursuing
successful development and commercialization of our product
portfolio, achieving successful commercial presence and growth,
while consistently delivering value to our shareholders, employees
and the medical providers and patients who will benefit from our
products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe-harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. Forward-looking statements
may include, but are not limited to statements preceded by,
followed by, or that include the words “expects,” “believes,”
“intends,” “anticipates,” and similar terms that relate to future
events, performance, or our results. Forward-looking statements
involve known risks and uncertainties, many of which are discussed
under the caption “Key Information - Risk Factors” in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission (“SEC”).
Such statements include, but are not limited to, statements about
the timing of, and prospects for, regulatory approval and
commercialization of our product candidates, statements about the
status of our efforts to establish a commercial operation and to
obtain the right to promote or sell products that we did not
develop and estimates regarding our capital requirements and our
needs for, and our ability to obtain, additional financing. Known
and unknown risks and uncertainties could cause our actual results
to differ materially from those in forward-looking statements. Such
risks and uncertainties include, among others, our now heavy
dependence on the success of Macrilen™ and the continued
availability of funds and resources to successfully complete the
submission of an NDA without undue delay with respect to Macrilen™
and, in the event the FDA approves Macrilen™, to successfully
launch the product, the rejection or non-acceptance of any new drug
application by one or more regulatory authorities and, more
generally, uncertainties related to the regulatory process, the
ability of the Company to efficiently commercialize one or more of
its products or product candidates (including, in particular,
Macrilen™), the degree of market acceptance once our products are
approved for commercialization (including, in particular,
Macrilen™), our ability to take advantage of business opportunities
in the pharmaceutical industry, our ability to protect our
intellectual property, the potential of liability arising from
shareholder lawsuits and general changes in economic conditions.
Investors should consult the Company’s quarterly and annual filings
with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties. Given these uncertainties
and risk factors, readers are cautioned not to place undue reliance
on these forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce any revisions to
any of the forward-looking statements contained herein to reflect
future results, events or developments, unless required to do so by
a governmental authority or applicable law.
Consolidated Statements of Comprehensive Loss
Information
(in thousands, except share and per share
data)
(unaudited)
Three months ended March 31, 2017
2016 $ $ Revenues Sales
commission and other
153 181 License fees
108
61
261 242
Operating expenses
Research and development costs
2,455 3,657 General and
administrative expenses
1,881 1,894 Selling expenses
1,542 1,682
5,878
7,233
Loss from operations (5,617 )
(6,991 ) Gain due to changes in foreign currency exchange
rates
65 468 Change in fair value of warrant liability
1,403 2,805 Other finance income
18 42
Net finance income 1,486 3,315
Net
loss (4,131 ) (3,676 )
Other comprehensive
(loss) income: Items that may be reclassified subsequently to
profit or loss: Foreign currency translation adjustments
(133 ) (469 ) Items that will not be reclassified to
profit or loss: Actuarial gain (loss) on defined benefit plans
441 (1,426 )
Comprehensive loss (3,823
) (5,571 )
Net loss per share (basic and diluted)
(0.31 ) (0.37 )
Weighted average number of shares
outstanding: Basic and Diluted
13,175,866
9,928,697
Consolidated Statement of
Financial Position Information
(in thousands)
As at March 31, As at December 31, (unaudited)
2017 2016 $ $ Cash and cash equivalents 1
17,777 21,999 Trade and other receivables and other current
assets
1,185 744 Restricted cash equivalents
500 496
Property, plant and equipment
184 204 Other non-current
assets
8,435 8,216
Total assets 28,081
31,659 Payables and other current liabilities
2,954 3,778 Current portion of deferred revenues
432
426 Warrant liability
5,451 6,854 Non-financial non-current
liabilities 2
13,892 14,389
Total liabilities
22,729 25,447 Shareholders' equity
5,352 6,212
Total liabilities and shareholders'
equity 28,081 31,659
_______________
1.
Approximately $0.9 million and $1.5
million were denominated in EUR as at March 31, 2017 and December
31, 2016, respectively, and approximately $2.5 million and $3.7
million were denominated in Canadian dollars as at March 31, 2017
and December 31, 2016, respectively.
2.
Comprised mainly of employee future
benefits, provisions for onerous contracts and non-current portion
of deferred revenues.
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version on businesswire.com: http://www.businesswire.com/news/home/20170508006226/en/
Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3211Senior Vice
PresidentIR@aezsinc.com
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