Prepares for Q4 2017 FDA Approval and Q1 2018 Commercial Launch
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 third quarter ended September 30, 2017.
Third Quarter 2017 Highlights:
Macimorelin development progressing toward completion with
Prescription Drug User Fee Act date of December 30, 2017;
Company prepares for the U.S. Food and Drug Administration ("FDA")
approval and Q1 2018 target commercial launch date;
Jeffrey A. Whitnell joins as Interim Chief Financial Officer;
Stifel, Nicolaus & Company, Incorporated retained as strategic
advisors;
Cash on hand of $12.2 million of unrestricted cash and cash
equivalents at quarter-end sufficient to take Macrilen™ through
approval and no third-party debt;
Company adopts disciplined business model focused on cost
containment through zero-based budgeting and preserving cash reserves
for Macrilen™ product launch.
"We are continuing our laser focus on preparation for the FDA approval
of Macrilen™ by December 30, 2017, which will be the only FDA-approved
drug for assessing adult growth hormone deficiency in the United
States," said Michael V. Ward, Aeterna Zentaris, Chief Executive
Officer. "Our goal is to launch the product in the first quarter of
2018. The Company has reached an important point in its evolution with
Jeff Whitnell joining us as the Interim Chief Financial Officer and
retention of Stifel Nicolaus during the quarter. We are making progress
building out a stronger management team and adopting a disciplined
process for strategic review of plans, resources and opportunities.
Going forward, we will continue to demonstrate our commitment to ensure
that we optimize the use of resources and capital and best position the
Company to maximize shareholder value."
"I am pleased at this time to report that we are almost $2 million
dollars ahead in cash reserves of where we thought we would be at this
time due to our disciplined new business model that focuses on cost
containment realized through zero-based budgeting, said Jeff Whitnell,
Interim Chief Financial Officer, Aeterna Zentaris. "These cash reserves
position us to take Macrilen™ through approval."
Third Quarter Financials
All Amounts are in U.S. Dollars
Revenues
Research and Development ("R&D") costs
General and Administrative ("G&A") Expenses
G&A expenses were $1.7 million and $5.4 million for both the three and
nine-month periods ended September 30, 2017, as compared to $1.6 million
and $5.4 million for the same periods in 2016. The G&A expenses were
in-line with our expectations.
Selling Expenses
Net Finance (Costs) Income
Net Loss
Liquidity
Conference Call
The Company will host a conference call to discuss these results on
Thursday, November 9, 2017 at 8:30 a.m., Eastern Time. Participants may
access the conference call using the following dial-in numbers:
Toll-Free: 877-407-8029, Confirmation #13672701
Toll: 201-689-8029, Confirmation #13672701
A replay of the conference call will also be available on the Company's
website for a period of 30 days.
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Revenues were $241,000 and $745,000 for the three and nine months ended
September 30, 2017, as compared to $269,000 and $607,000 for the same
periods in 2016. The year-to-date increase is mainly explained by the
expanded contract with Armune BioScience, Inc. (APIFINY®),
which was effective June 1, 2016 and the amortization of the up-front
payment received in connection with one of the out-licensing agreements
that we entered into in the third quarter of 2016 for ZoptrexTM.
R&D costs were $4.1 million and $10.2 million for the three and nine
months ended September 30, 2017, compared to $4.5 million and $11.9
million for the same periods in 2016. R&D costs decreased for the
three-month and nine-month periods ended September 30, 2017. The
decrease in our R&D costs is mainly attributable to lower comparative
third-party costs partially offset by the recording, in the third
quarter of 2017, of a provision in connection with the Restructuring
Program.
Third-party costs attributable to Zoptrex™ decreased during the three
and nine months ended September 30, 2017, as compared to the same period
in 2016, mainly due to the fact that we closed out the study and related
activities in the second quarter following the negative ZoptrexTM
top-line results on May 1, 2017. The negative costs for the three-month
period ended September 30, 2017 are mainly explained by lower close out
costs as compared to the accrual made in the second quarter.
Third-party costs attributable to Macrilen™ decreased during the three
and nine months ended September 30, 2017, as compared to the same period
in 2016. This is mainly due to the fact that we completed the Phase 3
clinical trial at the end of 2016. The costs incurred in 2017 related to
the detailed analysis of the top-line results as well as the preparation
of the New Drug Application ("NDA") filing which was submitted on June
30, 2017. The cost incurred in the third quarter of 2017 are explained
mainly by the close out costs as well as additional analysis required by
the FDA.
Selling expenseswere $1.7 million and $4.6 million for the three
and nine months ended September 30, 2017, as compared to $1.8 million
and $5.2 million for the same periods in 2016. Selling expenses for the
three and nine months ended September 30, 2017 and 2016 represent mainly
the costs of our sales force related to 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 since February 2017. In July 2017, we further reduced the
number of sales representative to 10 and we reduced our headcount by one
sales manager. Following the creation of the Strategic Review Committee,
the board of directors of the Company is currently evaluating options to
be ready to promote Macrilen™ quickly following the expected approval.
Net finance (costs) incomewas $(2.4) million and $3.2 million
for the three and nine months ended September 30, 2017, as compared to
$1.6 million and $5.1 million, for the same periods 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 $0.84 to $3.65 during the nine-month period ended
September 30, 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 for the three and nine months ended September 30, 2017 was $9.6
million and $16.3 million (or $0.61 and $1.13 per share), as compared to
a net loss of $6.1 million and $16.7 million (or $0.61 and $1.68 per
share) for the same periods in 2016. The increase in net loss for the
three-month period ended September 30, 2017 is mainly explained by the
change in fair value of the warrant liability due to the increase in the
share price since June 30, 2017. However, the loss per share during the
same period remained stable due to the increase in the weighted average
number of shares due to a share issuance done in November 2016 and
"at-the-market" issuances done in 2017. The increase in the weighted
average number of shares also explains the decrease in the loss per
share for the nine-month period.
Cash and cash equivalents were $12.2 million as at September 30, 2017,
as compared to $22.0 million as at December 31, 2016. The decrease in
cash and cash equivalents as at September 30, 2017, as compared to
December 31, 2016, is due to the net cash used in operating activities
including 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 "at-the-market" programs.
For reference, management's discussion and analysis of financial
condition and results of operations for the third quarter ended
September 30, 2017, as well as the Company's interim condensed
consolidated financial statements as at September 30, 2017, can be found
at www.aezsinc.com
in the "Investors" section.
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 resubmitted an NDA to the FDA seeking approval
of Macrilen™, an internally developed compound. 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.
This press release contains forward-looking statements made pursuant to
the safe-harbor provision of the U.S. Securities Litigation Reform Act
of 1995 and applicable Canadian securities laws, 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,", "would",
"could", "may" "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 launch the product in the event the FDA
approves Macrilen™, the rejection or non-acceptance of the NDA by one or
more regulatory authorities and, more generally, uncertainties related
to the regulatory process, the ability of the Company to efficiently
commercialize Macrilen™, the degree of market acceptance of Macrilen™ in
the event it is approved for commercialization by the FDA, our ability
to obtain necessary approvals from the relevant regulatory authorities
to enable us to use the desired brand names for our products, the impact
of securities class action litigation, the litigation involving two
former officers of the Company, or other litigation on our cash flow,
results of operations and financial position; any evaluation of
potential strategic alternatives to maximize potential future growth and
stakeholder value may not result in any such alternative being pursued,
and even if pursued, may not result in the anticipated benefits,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 applicable 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.
Condensed Interim Consolidated Statement of Financial Position
Information
(In thousands)
As at September 30,
As at December 31,
(unaudited)
2017
2016
$
$
Cash and cash equivalents 1
12,173
21,999
Trade and other receivables and other current assets
802
744
Restricted cash equivalents
377
496
Property, plant and equipment
154
204
Other non-current assets
9,032
8,216
Total assets
22,538
31,659
Payables and other current liabilities
2,665
3,745
Provision for restructuring costs
2,452
33
Current portion of deferred revenues
479
426
Warrant liability
3,419
6,854
Non-financial non-current liabilities 2
15,478
14,389
Total liabilities
24,493
25,447
Shareholders' (deficiency) equity
(1,955
)
6,212
Total liabilities and shareholders' (deficiency) equity
22,538
31,659
Approximately $1.0 million and $1.5 million were denominated in EUR as
at September 30, 2017 and December 31, 2016, respectively, and
approximately $1.7 million and $3.7 million were denominated in
Canadian dollars as at September 30, 2017 and December 31, 2016,
respectively.
Comprised mainly of employee future benefits, provisions for onerous
contracts and non-current portion of deferred revenues.
Condensed Interim Consolidated Statements of Comprehensive Loss
Information
(In thousands, except share and per share data)
Three months ended
Nine months ended
September 30, 2017
September 30, 2017
(unaudited)
2017
2016
2017
2016
$
$
$
$
Revenues
Sales commission and other
122
105
406
319
License fees
119
164
339
288
241
269
745
607
Operating expenses
Research and development costs
4,124
4,512
10,178
11,876
General and administrative expenses
1,665
1,631
5,420
5,390
Selling expenses
1,652
1,829
4,643
5,219
7,441
7,972
20,241
22,485
Loss from operations
(7,200
)
(7,703
)
(19,496
)
(21,878
)
Gain (loss) due to changes in foreign currency exchange rates
169
(64
)
430
326
Change in fair value of warrant liability
(2,617
)
1,687
2,700
4,682
Other finance income
17
25
54
131
Net finance (costs) income
(2,431
)
1,648
3,184
5,139
Net loss
(9,631
)
(6,055
)
(16,312
)
(16,739
)
Other comprehensive (loss) income:
Items that may be reclassified subsequently to profit or loss:
Foreign currency translation adjustments
(400
)
(62
)
(1,192
)
(301
)
Items that will not be reclassified to profit or loss: