Near-Term Major Inflection Point Approaching with Expected
Completion of two Pivotal Phase 3 Programs in 2016
All $ amounts are in US Dollars
Key developments
- Product development programs on
track towards FDA submission in 2017
- Zoptrex™ (zoptarelin doxorubicin)
pivotal Phase 3 clinical program remains on track for completion in
2016
- Macrilen™ (macimorelin) confirmatory
Phase 3 Trial for the evaluation of AGHD also remains on track for
completion in 2016
- Zoptrex™ out-licensing activity
successfully continues
- Zoptrex™ licensee in China and related
territories, Sinopharm A-Think Pharmaceuticals Co., Ltd., filed IND
with Chinese FDA on June 14, 2016, and expects to commence clinical
program in H1 of 2017
- License, Tech Transfer and Supply
Agreements concluded with affiliates of Orient EuroPharma Co., Ltd,
for Taiwan and southeast Asia on July 1, 2016
- License and Supply Agreements concluded
with Rafa Laboratories Ltd. for Israel and the Palestinian
territory on July 31, 2016
- Financial condition as
anticipated
- $26.2 million unrestricted cash and
cash equivalents at Quarter end
- 9,939,863 Common Shares outstanding at
Quarter end
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”),
a specialty biopharmaceutical company engaged in developing and
commercializing novel treatments in oncology, endocrinology and
women’s health, today reported financial and operating results for
the second quarter ended June 30, 2016.
Commenting on recent key developments, David A. Dodd, President
and Chief Executive Officer of the Company, stated, “After the end
of Q2, we concluded two important out-license agreements for
Zoptrex™, confirming the market’s interest in our lead oncology
compound, Zoptrex™ (zoptarelin doxorubicin). Zoptrex™ is a novel
synthetic peptide carrier linked to doxorubicin as a New Chemical
Entity (NCE). Based on recent information regarding the survival of
patients in the Phase 3 clinical trial of Zoptrex™, we expect to
complete the trial by year-end. If the results of the trial warrant
doing so, we intend to file a new drug application for Zoptrex™ in
the first half of 2017.”
Mr. Dodd continued his commentary with an update on the
development of Macrilen™ (macimorelin), “We are pleased to announce
that we should complete enrollment in our confirmatory Phase 3
study of Macrilen™ for the evaluation of adult growth hormone
deficiency by the end of August. As a result, we are very confident
that the study of Macrilen™ will be concluded in 2016. If our
expectations for completion of the confirmatory Phase 3 study are
realized and if the top-line results indicate that the product
attained the primary endpoint of the Phase 3 study, we expect to
file an NDA for Macrilen™ during the first half of 2017. Since the
regulatory review period for the Macrilen™ confirmatory study is
six months, we could begin commercializing the product late in
2017.”
Second Quarter 2016 Financial Highlights
R&D costs were $3.7 million for the three-month period ended
June 30, 2016 and $7.4 million for the six-month period then ended,
compared to $4.5 million and $8.9 million, respectively, for the
three-month and six-month periods ended June 30, 2015. The decrease
for the three-month and six-month periods ended June 30, 2016, as
compared to the same period in 2015, is mainly attributable to
lower comparative third-party costs. Third-party costs attributable
to Zoptrex™ decreased considerably during the three-month and
six-month periods ended June 30, 2016, as compared to the same
periods in 2015, mainly due to the fact that dosing of patients in
the ZoptEC trial was completed in February 2016. This is consistent
with our expectations as we are approaching the end of the clinical
trials. In addition, during 2015, we started the confirmatory Phase
3 clinical trial of Macrilen™, which explains the increase in costs
for this product candidate. The overall decrease in R&D costs
is also explained by lower employee compensation and benefits
costs, lower facilities rent and maintenance as well as lower other
costs. A substantial portion of this decrease is due to the
realization of cost savings in connection with our effort to
streamline our R&D activities and to increase our commercial
operations and flexibility by reducing our R&D staff, which was
started in 2014, and for which a provision was recorded in the
third quarter of 2014.
G&A expenses were $1.9 million for the three-month period
ended June 30, 2016, and $3.8 million for the six-month period then
ended, compared to $2.0 million and $5.4 million, respectively, for
the three-month and six-month periods ended June 30, 2015. The
comparative decrease for the six-month period is mainly
attributable to the recording, in the prior year quarter, of
certain transaction costs allocated to warrants in connection with
the completion of the March 2015 Offering.
Selling expenses were $1.7 million for the three-month period
ended June 30, 2016 and $3.4 million for the six-month period then
ended, essentially unchanged as compared to the three-month and
six-month periods ended June 30, 2015. The selling expenses for the
three- and six-month periods ended June 30, 2016 and 2015 represent
the costs of our contracted sales force related to the co-promotion
activities as well as our internal sales management team. Those
activities were launched during the fourth quarter of 2014.
Net loss for the three-month and six-month periods ended June
30, 2016 were $7.0 million and $10.7 million, respectively, or
$0.71 and $1.08, respectively, both per basic and diluted share.
During the same three-month and six-month periods in 2015, our net
loss was $15.1 million and $24.8 million, respectively, or $13.65
and $27.22, respectively, per basic and diluted share for the same
period in 2015. The decrease in net loss for the three-month and
six- month periods ended June 30, 2016, as compared to the same
periods in 2015, is due largely to lower operating expenses and
higher comparative net finance income.
Cash and cash equivalents were approximately $26.2 million as at
June 30, 2016, compared to approximately $33.0 million as at March
31, 2016.
Conference Call & Webcast
The Company will host a conference call and live webcast to
discuss these results on Wednesday, August 10, 2016, 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 number: 201-689-8029,
Confirmation #13640170. A replay of the webcast will also be
available on the Company’s website for a period of 30 days.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women’s health. We are engaged in drug
development activities and in the promotion of products for others.
We are now conducting Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition or license of 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
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 provisions of the US Securities
Litigation Reform Act of 1995. 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 and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects and clinical trials, the successful and timely
completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, 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, the degree of market acceptance once our
products are approved for commercialization, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, the 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 US securities commissions for additional information
on risks and uncertainties relating to forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, except if
required to do so.
Condensed Interim Consolidated
Statements of Comprehensive Loss Information
(in thousands, except share and per share
data)
Three months ended June 30, Six months ended June
30, (Unaudited)
2016 2015
2016 2015 $ $
$
$ Revenues Sales Commission and Other
33 81
214 81 License fees
63 116
124
189
96 197
338 270
Operating expenses Research and development costs
3,707 4,476
7,364 8,941 General and administrative
expenses
1,865 2,001
3,759 5,445 Selling expenses
1,708 1,709
3,390 3,409
7,280 8,186
14,513 17,795
Loss from operations (7,184 ) (7,989 )
(14,175 ) (17,525 ) (Loss) gain due to changes in
foreign currency exchange rates
(78 ) 389
390
(1,085 ) Change in fair value of warrant liability
190
(7,603 )
2,995 (6,413 ) Other finance income
64
55
106 239
Net finance income
(costs) 176 (7,159 )
3,491 (7,259 )
Net loss from continuing operations
(7,008 ) (15,148
)
(10,684 ) (24,784 ) Net income (loss) from
discontinued operations
— 49
—
(51 )
Net loss (7,008 ) (15,099 )
(10,684 ) (24,835 )
Other comprehensive loss:
Items that may be reclassified subsequently to profit or loss:
Foreign currency translation adjustments
230 (494 )
(239 ) 1,281 Items that will not be reclassified to
profit or loss: Actuarial (loss) gain on defined benefit plans
(797 ) 2,261
(2,222 ) 960
Comprehensive loss (7,575 ) (13,332 )
(13,145 ) (22,594 )
Net loss per share (basic and
diluted) from continuing operations (0.71 )
(13.69 )
(1.08 ) (27.16 )
Net income (loss) per
share from discontinued operations — 0.04
— (0.06 )
Net loss per share (basic and
diluted) (0.71 ) (13.65 )
(1.08 )
(27.22 )
Weighted average number of shares: Basic
9,936,541 1,106,399
9,932,641
912,545 Diluted
9,936,541 1,106,399
9,932,641 912,545
Consolidated Interim Consolidated
Statement of Financial Position Information
(in thousands)
As at June 30, As at December 31, (Unaudited)
2016 2015 $ $ Cash and cash
equivalents1
26,169 41,450 Trade and other receivables and
other current assets
1,371 944 Restricted cash equivalents
261 255 Property, plant and equipment
236 256 Other
non-current assets
9,030 8,593
Total assets
37,067 51,498 Payables and other current liabilities2
3,764 4,770 Current portion of deferred revenues
249
244 Warrant liability (current and non-current portions)
7,896 10,891 Non-financial non-current liabilities3
16,107 13,978
Total liabilities 28,016
29,883
Shareholders' equity 9,051
21,615
Total liabilities and shareholders' equity
37,067 51,498 _________________________ 1
Approximately $2.3 and $1.5 million were
denominated in EUR as of June 30, 2016 and December 31, 2015,
respectively and approximately $4.7 and $4.4 million were
denominated in Canadian dollars as of June 30, 2016 and December
31, 2015, respectively.
2 Approximately $0.1 and $0.6 million related to our provision for
restructuring as at June 30, 2016 and December 31, 2015,
respectively. 3 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/20160809005227/en/
Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3211Senior Vice
PresidentIR@aezsinc.com
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