Pivotal Phase 3 Programs for Macrilen™ and
Zoptrex™ Expected Completion in Q3 2016
All $ amounts are in US Dollars
First quarter key developments
- Product development on track towards
registration
- Zoptrex™ (zoptarelin doxorubicin)
pivotal Phase 3 clinical program on track for completion in Q3
2016
- Zoptrex™ licensee in China and related
territories, Sinopharm A-Think Pharmaceuticals Co., Ltd., scheduled
to file IND in Q2 2016 and to commence clinical study in H2 of
2016
- Macrilen™ (macimorelin) confirmatory
Phase 3 Trial for the evaluation of AGHD enrollment and site
initiation also on track for completion in Q3 2016
- Co-promotion commission revenue
showing favorable trend
- Saizen® new-patient-starts exceeded the
baseline by over 66%; new-patient-starts increased 88% over the
fourth quarter of 2015
- APIFINY® generates commission revenue,
although promotion by entire sales force began only midway through
first quarter.
- APIFINY® agreement expanded to
exclusive promotion agreement throughout the U.S. effective June
1.
- Solid Financial condition as
anticipated
- $33.0 million unrestricted cash and
cash equivalents at Quarter end
- Expected average monthly operating burn
rate of approximately $2.8 million during remainder of 2016
- No Common Shares issued during Quarter;
9,928,697 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 first quarter ended March 31, 2016.
Commenting on first quarter results, David A. Dodd, Chairman,
President and Chief Executive Officer of the Company, stated,
“During the first quarter, we made steady progress in the areas of
product development, commercial performance and financial
operations. I am pleased to report that we remain on track to
attain our 2016 corporate objectives. We still expect to complete
the pivotal Phase 3 Zoptrex™ trial in Q3 of 2016 and to report
top-line results by year-end.”
Mr. Dodd continued his commentary with a discussion of the
development of Macrilen™, which, if approved, will be the only
FDA-approved means of evaluating adult growth hormone deficiency
(AGHD), “Since announcing patient recruitment in the fourth quarter
of last year, our CRO has opened approximately 20 of our
anticipated 30 sites, enrolling approximately 30 patients. The pace
of recruitment is accelerating, confirming our expectation that the
confirmatory Phase 3 clinical study of Macrilen™ will be concluded
in Q3 of 2016, also with top-line results being reported as soon as
possible following trial conclusion. We feel very confident that
the confirmatory study, which will consist of approximately 30
sites and a minimum of 110 patients, is on schedule.”
Concluding, Mr. Dodd addressed the Company’s commercial
operations, stating, “We are pleased with the building of success
from our promotion of Saizen® during the first quarter. Exceeding
our baseline by 66% during the quarter was a great accomplishment
by our sales team. Now that they have a number of targets that more
closely matches our promotional capacity, we believe they should be
in a position to produce meaningful commission revenue this year. I
am hopeful that we will be able to add even more targets as EMD
Serono recognizes the success of our efforts. Our full sales force
sold APIFINY® for only half of the first quarter but managed to
generate commission revenue nevertheless. We are hopeful about the
commercial potential of APIFINY® because it is the only
cancer-specific, non-PSA blood test for the evaluation of the risk
of prostate cancer. Physicians have long needed such an adjunct to
the PSA test. With APIFINY®, we believe we can satisfy that need.
As a result of our promotional efforts, we are realizing an
increasing penetration and acceptance of APIFINY®. More recently,
we announced the expansion of our APIFINY® agreement to reflect our
exclusive rights to promote this product throughout the U.S. We
believe that such an expanded agreement opens significant revenue
opportunities in support of this exciting product.”
First Quarter 2016 Financial Highlights
R&D costs were $3.7 million for the three-month period ended
March 31, 2016, compared to $4.5 million for the same period in
2015. The decrease for the three-month period ended March 31, 2016,
as compared to the same period in 2015, is mainly attributable to
lower comparative third-party costs. The decrease in third-party
costs is mainly attributable to the fact that the number of
patients in active treatment in the clinical trial for Zoptrex™ was
lower in the first quarter of 2016, as compared to the same period
in 2015. 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 (the
"Resource Optimization Program"), 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 March 31, 2016, as compared to $3.4 million for the same
period in 2015. The decrease is mainly attributable to the
recording during three-month period ended March 31, 2015 of certain
transaction costs associated with the completion of a public,
registered offering of shares and warrants in March 2015.
Selling expenses were $1.7 million for the three-month period
ended March 31, 2016, essentially unchanged as compared to the same
period in 2015. The selling expenses for the three-month periods
ended March 31, 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 period ended March 31, 2016 was
$3.7 million, or $0.37 per basic and diluted share, compared to a
net loss of $9.7 million, or $13.59 per basic and diluted share for
the same period in 2015. The decrease in net loss for the
three-month period ended March 31, 2016, as compared to the same
period in 2015, is due largely to lower operating expenses and
higher comparative net finance income.
Cash and cash equivalents were approximately $33.0 million as at
March 31, 2016, compared to $41.5 million as at December 31,
2015.
Conference Call & Webcast
The Company will host a conference call and live webcast to
discuss these results on Tuesday, May 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 #13635224. 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
(Unaudited)
Three months ended March 31, (in thousands, except
share and per share data)
2016 2015
$ $ Revenues Sales Commission and Other
181 — License fees
61 73
242
73
Operating expenses Research and development
costs
3,657 4,466 General and administrative expenses
1,894 3,443 Selling expenses
1,682 1,700
7,233 9,609
Loss from operations
(6,991 ) (9,536 ) Gain (loss) due to changes in
foreign currency exchange rates
468 (1,474 ) Change in fair
value of warrant liability
2,805 1,189 Other finance income
42 185
Net finance income (costs)
3,315 (100 )
Net loss from continuing
operations (3,676 ) (9,636 )
Net loss from
discontinued operations — (100 )
Net loss
(3,676 ) (9,736 )
Other comprehensive loss:
Items that may be reclassified subsequently to profit or loss:
Foreign currency translation adjustments
(469 ) 1,775
Items that will not be reclassified to profit or loss: Actuarial
loss on defined benefit plans
(1,426 ) (1,301 )
Comprehensive loss (5,571 ) (9,262 )
Net
loss per share (basic and diluted) from continuing operations
(0.37 ) (13.45 )
Net loss per share (basic and
diluted) from discontinued operations — (0.14 )
Net loss per share (basic and diluted) (0.37 )
(13.59 )
Weighted average number of shares outstanding:
Basic
9,928,697 716,536 Diluted
9,928,697 716,536
Consolidated Interim Consolidated
Statement of Financial Position Information
(Unaudited)
As at March 31, As at December 31, (in
thousands)
2016 2015 $ $ Cash
and cash equivalents1
32,981 41,450 Trade and other
receivables and other current assets
1,358 944 Restricted
cash equivalents
266 255 Property, plant and equipment
231 256 Other non-current assets
9,210 8,593
Total
assets 44,046 51,498 Payables and other current
liabilities2
3,643 4,770 Current portion of deferred
revenues
254 244 Warrant liability (current and non-current
portion)
8,086 10,891 Non-financial non-current liabilities3
15,766 13,978
Total liabilities 27,749 29,883
Shareholders' equity 16,297 21,615
Total
liabilities and shareholders' equity 44,046 51,498
1 Approximately $1.1 and $1.5 million are
denominated in EUR as at March 31, 2016 and
December 31, 2015, respectively.
2 Approximately $0.2 and $0.6 million
related to our provision for restructuring as at
March 31, 2016 and December 31, 2015,
respectively.
3 Comprised mainly of employee future
benefits, provisions for onerous contracts and
non-current portion of deferred
revenues.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160509006633/en/
Aeterna Zentaris Inc.Philip A. Theodore, Senior Vice
President843-900-3211, IR@aezsinc.com
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