Aeterna Zentaris Reports Second Quarter 2018 Financial and Operating Results
August 09 2018 - 4:19PM
Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZS), a
biopharmaceutical company engaged in developing and commercializing
pharmaceutical products, today reported financial and operating
results for the second quarter ended June 30, 2018.
All Amounts are in U.S. Dollars
Recent Key Developments
- The Company’s U.S. and Canadian out-licensing partner,
Strongbridge Biopharma plc (NASDAQ: SBBP) officially launched our
product Macrilen™ (macimorelin) in the United States effective July
23, 2018. Macrilen™ is the first and only FDA-approved oral ghrelin
receptor agonist to be administered in the diagnosis of patients
with adult growth hormone deficiency (AGHD) in the United
States.
- The Company successfully submitted its required response to the
European Medicines Agency (EMA) for the use of macimorelin for the
evaluation of AGHD in July 2018.
- The Company continues to respond to out-licensing and other
commercial partners for other markets globally.
- The Company’s financial condition remains strong with $19.9
million of cash and cash equivalents and
no debt.
Commenting on recent key developments, Michael
V. Ward, President and Chief Executive Officer for Aeterna
Zentaris, stated, "We are very pleased with the continued progress
being made by the Company in achieving our growth strategy of
maximizing the global value of macimorelin. We are also very
pleased with the launch of Macrilen™ in the United States."
Second Quarter Financial
Highlights
- Cash $19.9 million
- Revenues $0.2 million
- Research and Development (“R&D") Costs $1.0
million
- General and Administrative (“G&A") Expenses $2.0
million
- Net loss $2.6 million
The Company will host a conference call to
discuss these results on Friday, August 10, 2018, at 8:30 a.m.,
Eastern Time. Participants may access the conference call by
telephone using the following dial-in numbers:
- Toll-Free: 877-407-8029, Confirmation #13681858
- Toll: 201-689-8029, Confirmation #13681858
A replay of the conference call 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 second quarter 2018, as
well as the Company’s audited consolidated financial statements as
at June 30, 2018, 2017, 2016 and 2015, can be found
at www.zentaris.com in the "Investors" section.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a biopharmaceutical company focused on
developing and commercializing, principally through out-licensing
arrangements, Macrilen™ (macimorelin), an oral ghrelin receptor
agonist, to be administered in the diagnosis of patients with adult
growth hormone deficiency. Aeterna Zentaris has licensed
Macrilen™ (macimorelin) to Strongbridge Biopharma plc in the United
States and Canada. For more information, visit
www.zentaris.com.
Forward-Looking Statements
This press release contains forward-looking
statements (as defined by applicable securities legislation) 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 "will," "expects,"
"believes," "intends," "would," "could," "may," "anticipates," and
similar terms that relate to future events, performance, or our
results. Forward-looking statements involve known and unknown
risks and uncertainties, including those discussed in this press
release and in our Annual Report on Form 20-F, under the caption
"Key Information - Risk Factors" 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").
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™ (macimorelin) and
related out-licensing arrangements and the continued availability
of funds and resources to successfully launch the product, the
ability of Aeterna Zentaris to enter into out-licensing,
development, manufacturing and marketing and distribution
agreements with other pharmaceutical companies and keep such
agreements in effect, reliance on third parties for the
manufacturing and commercialization of our product candidates,
potential disputes with third parties, leading to delays in or
termination of the manufacturing, development, out-licensing or
commercialization of our product candidates, or resulting in
significant litigation or arbitration, and, more generally,
uncertainties related to the regulatory process, our ability to
efficiently commercialize or out-license Macrilen™
(macimorelin), the degree of market acceptance of Macrilen™
(macimorelin), 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 of our former officers,
litigation brought by Cogas Consulting, LLC, 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 our 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.
Contacts:
Aeterna Zentaris Inc. James Clavijo Chief Financial Officer
IR@aezsinc.com 843-900-3201
Condensed Interim Consolidated
Statements of Comprehensive Income (Loss)
Information
|
|
|
|
|
|
|
Three months endedJune 30, |
|
Six months endedJune 30, |
(in thousands, except
share and per share data) |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
|
Sales commission and
other |
|
79 |
|
|
131 |
|
|
169 |
|
|
284 |
|
Licensing revenue |
|
89 |
|
|
112 |
|
|
24,657 |
|
|
220 |
|
Total revenues |
|
168 |
|
|
243 |
|
|
24,826 |
|
|
504 |
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold |
|
197 |
|
|
— |
|
|
197 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
Research and
development costs |
|
974 |
|
|
3,599 |
|
|
1,807 |
|
|
6,054 |
|
General and
administrative expenses |
|
2,004 |
|
|
1,874 |
|
|
4,790 |
|
|
3,755 |
|
Selling expenses |
|
497 |
|
|
1,449 |
|
|
2,138 |
|
|
2,991 |
|
Total operating
expenses |
|
3,475 |
|
|
6,922 |
|
|
8,735 |
|
|
12,800 |
|
(Loss) income
from operations |
|
(3,504 |
) |
|
(6,679 |
) |
|
15,894 |
|
|
(12,296 |
) |
|
|
|
|
|
|
|
|
|
Gain due to changes in
foreign currency exchange rates |
|
677 |
|
|
196 |
|
|
725 |
|
|
261 |
|
Change in fair value of
warrant liability |
|
(134 |
) |
|
3,914 |
|
|
1,694 |
|
|
5,317 |
|
Other finance
income |
|
126 |
|
|
19 |
|
|
144 |
|
|
37 |
|
Net finance
income |
|
669 |
|
|
4,129 |
|
|
2,563 |
|
|
5,615 |
|
(Loss) income before
income taxes |
|
(2,835 |
) |
|
(2,550 |
) |
|
18,457 |
|
|
(6,681 |
) |
Income taxes |
|
233 |
|
|
— |
|
|
(6,635 |
) |
|
— |
|
Net (loss)
income |
|
(2,602 |
) |
|
(2,550 |
) |
|
11,822 |
|
|
(6,681 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Items that may be
reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
|
Foreign
currency translation adjustments |
|
(28 |
) |
|
(659 |
) |
|
(250 |
) |
|
(792 |
) |
Items that will not be
reclassified to profit or loss: |
|
|
|
|
|
|
|
|
Actuarial
gain on defined benefit plans |
|
205 |
|
|
194 |
|
|
205 |
|
|
635 |
|
Comprehensive
(loss) income |
|
(2,425 |
) |
|
(3,015 |
) |
|
11,777 |
|
|
(6,838 |
) |
Net (loss)
income per share (basic) |
|
(0.16 |
) |
|
(0.18 |
) |
|
0.72 |
|
|
(0.49 |
) |
Net (loss)
income per share (diluted) |
|
(0.16 |
) |
|
(0.18 |
) |
|
0.70 |
|
|
(0.49 |
) |
Weighted
average number of shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
16,440,760 |
|
|
14,086,508 |
|
|
16,440,760 |
|
|
13,776,045 |
|
Diluted |
|
16,440,760 |
|
|
14,086,508 |
|
|
16,489,364 |
|
|
13,776,045 |
|
|
Condensed Interim Consolidated Statement of
Financial Position Information
|
|
|
|
|
(in thousands, except
share and per share data) |
|
As at June 30, |
|
As at December 31, |
|
|
2018 |
|
2017 |
|
|
$ |
|
$ |
Cash and cash
equivalents |
|
19,946 |
|
7,780 |
Trade and other
receivables and other current assets |
|
1,367 |
|
958 |
Inventory |
|
1,397 |
|
643 |
Restricted cash
equivalents |
|
373 |
|
381 |
Property, plant and
equipment |
|
75 |
|
101 |
Deferred tax
assets |
|
— |
|
3,479 |
Other non-current
assets |
|
8,476 |
|
8,853 |
Total
assets |
|
31,634 |
|
22,195 |
Payables and other
current liabilities |
|
2,146 |
|
2,987 |
Current portion of
deferred revenues |
|
— |
|
486 |
Warrant liability |
|
2,203 |
|
3,897 |
Provision for
restructuring costs |
|
566 |
|
2,296 |
Taxes payable |
|
2,904 |
|
— |
Non-financial
non-current liabilities |
|
14,305 |
|
15,312 |
Total
liabilities |
|
22,124 |
|
24,978 |
Shareholders'
equity (deficiency) |
|
9,510 |
|
(2,783) |
Total
liabilities and shareholders' equity (deficiency) |
|
31,634 |
|
22,195 |
|
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