All amounts are in U.S. dollars
QUEBEC CITY,
Aug. 14, 2012 /PRNewswire/ - Aeterna
Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"),
today reported financial and operating results as at and for the
second quarter ended June 30,
2012.
Highlights
Perifosine (Oral Akt Inhibitor)
- Phase 3 results for perifosine in refractory colorectal cancer
presented at ASCO in Chicago. Data
showed no benefit in overall survival and in progression-free
survival when adding perifosine to capecitabine in the refractory
colorectal cancer setting. Data also showed no significant
difference in toxicity profiles between the two arms, confirming
top line results previously disclosed by the Company on
April 2, 2012.
- Termination of license agreement with Keryx Biopharmaceuticals,
Inc. ("Keryx"), resulted in Aeterna Zentaris regaining full North
American rights to perifosine in all indications.
- Company took over the ongoing Phase 3 trial in multiple
myeloma from Keryx, with a pre-planned interim analysis expected in
Q1 2013.
- Japanese partner, Yakult Honsha ("Yakult"), initiated a Phase 1
trial in Japan with perifosine in
multiple myeloma, which it is sponsoring.
- Phase 1 data for perifosine in multiple myeloma published in
June issue of the British Journal of Haematology. The
article outlined the safety profile and encouraging clinical
activity of perifosine when combined with lenalidomide and
dexamethasone in relapsed and relapsed/refractory multiple
myeloma.
- Article in May issue of PLoS ONE, outlined perifosine's
potential as a novel approach for the treatment of mesothelioma, an
aggressive type of cancer associated with exposure to asbestos.
Data also described a novel mechanism of perifosine that
interferes, upstream of Akt, affecting EGFR and MET
phosphorylation.
- Phase 1 results for perifosine presented at the Advances in
Neuroblastoma Conference in Toronto, showed its single-agent activity
against neuroblastoma, a type of childhood cancer which usually
begins in the neural tissues.
- Phase 2 data for perifosine as monotherapy in renal cell
carcinoma published in June Issue of Cancer. The article
outlined perifosine's anticancer activity which was comparable to
current second-line agents, and authors concluded that the compound
may be worthy of further investigation in this indication in
combination with available therapies.
AEZS-130 (Oral Ghrelin Agonist)
- Final Phase 3 results for AEZS-130 as diagnostic test for Adult
Growth Hormone Deficiency ("AGHD") presented at ENDO in
Houston, showed the compound to be
safe and effective in diagnosing AGHD.
- Subsequent to quarter-end, the Company filed a request with the
FDA for Fast Track designation and a rolling submission for
AEZS-130 as a diagnostic test for AGHD, as part of its New Drug
Application ("NDA") strategy.
- Subsequent to quarter-end, the U.S. Patent and Trademark Office
granted a patent for the use of AEZS-130 (EP1572) as a diagnostic
test for AGHD. Patent will expire on October
12, 2027.
AEZS-108 (LHRH agonist linked to doxorubicin)
- Special Protocol Assessment ("SPA") for Phase 3 trial in
endometrial cancer expected to be filed during September 2012.
AEZS-136 (Oral PI3K/Akt Inhibitor)
- Poster on AEZS-136 presented at AACR in Chicago, showed the compound's unique
inhibition and excellent preclinical activity against PI3K and Erk
signaling pathways, as well as being well tolerated.
Corporate Developments
Delisting Risk
- Notification received from NASDAQ regarding the failure by the
Company to comply with the NASDAQ's minimum bid price requirements.
Company has been given until November 12,
2012 to regain compliance.
Share Consolidation (Reverse Stock Split)
- Subsequent to quarter-end, Company convened a Special Meeting
of Shareholders for August 15,
2012, asking shareholders to consider and authorize the
Board of Directors to effect, in its discretion, a share
consolidation (or reverse stock split) of the outstanding common
shares.
At-The-Market Issuance Program (ATM Program)
- During the three-month period ended June
30, 2012, pursuant to the January
2012 ATM Program, the Company issued a total of 2.6 million
common shares for gross proceeds of approximately $1.9 million.
Appointment to Board of Directors
- Subsequent to quarter-end, Carolyn
Egbert, former Senior Executive Vice President at Solvay
North America, was appointed to the Board of Directors. Her
appointment is based on her expertise in pharmacology, human
resources and corporate governance with a focus on organizational
design and global restructuring. She was also a on the Board of
Directors of Solvay North America and its subsidiaries Peptisyntha
and Solvay Enzymes.
Cash and cash equivalents totalled $39.8 million as at June 30, 2012, compared to $46.9 million as at December 31, 2011.
Juergen Engel, PhD, Aeterna
Zentaris President and Chief Executive Officer, commented,
"Unfortunately, the last quarter was marked by unexpected
disappointing results for the perifosine Phase 3 trial in
colorectal cancer. Nevertheless, we pushed forward with a strategic
plan aimed at refocusing the Company's activities and implementing
cost-cutting measures in order to control our burn-rate.
As for perifosine, we decided to continue the Phase 3 trial in
multiple myeloma as we believe this compound still has the
potential to become a novel oral anticancer treatment. Meanwhile,
our partner, Yakult, initiated a Phase 1 trial in the same
indication in Japan, showing their
belief in perifosine's potential. Our NDA filing proceedings for
AEZS-130 as an oral diagnostic test for AGHD continued to make
progress with our request to the FDA for Fast Track designation in
the hope of accelerating the review process; and just last week, we
announced that AEZS-130 had been granted a patent for the U.S. in
this same indication, which will expire in 2027. Still with
AEZS-130, the Michael E. DeBakey VA Medical Center initiated a
Phase 2 trial with this compound as a treatment for cancer
cachexia. Regarding AEZS-108, we expect to file a SPA in September
for our upcoming Phase 3 trial in endometrial cancer.
At the human resources level, we implemented an attrition policy
whereby approximately 16% of the workforce at our facility in
Germany were terminated or will
terminate over the next year; we gained access to governmental
programs which refund salaries for another approximately 6% of our
German workforce; and put some of our earlier-stage drug
development programs on hold to focus on our late-stage
programs.
We believe that the strategic plan that we have put in place
will enable us to overcome our recent set back as we remain
committed to moving our late-stage drugs to market for the benefit
of both patients and shareholders."
Dennis Turpin, CPA, CA, Senior
Vice President and Chief Financial Officer at Aeterna Zentaris
stated, "As of June 30, 2012, we had
a cash position of $39.8 million
which allows us to be well poised to continue to move our key
product candidates through the pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE SECOND QUARTER ENDED
JUNE 30, 2012
Revenues were $7.5 million
for the quarter ended June 30, 2012,
compared to $6.5 million for the
same quarter in 2011. This increase is largely attributable to
comparative higher deliveries of Cetrotide® to certain
customers and to higher research and development services provided,
partly offset by the relative weakening of the euro against the US
dollar.
R&D costs, net of refundable tax credits and grants
were relatively stable at $5.2
million for the quarter ended June 30, 2012, compared to $5.6 million for the same quarter in 2011.
Finance income was $12.1
million for the quarter ended June
30, 2012, compared to finance costs of $2.6 million for the same quarter in 2011.
The significant increase in net finance income is mainly due to the
change in fair value of our warrant liability, as well as to gains
due to changes in foreign currency exchange rates which are mainly
related to the period-over-period continued weakness of the Euro
against the U.S. dollars
Net income amounted to $4.5
million, or $0.04 per basic
and diluted share, for the quarter ended June 30, 2012, compared to a net loss of
$10.6 million, or $0.12 per basic and diluted share, for the same
quarter in 2011. This significant decrease in net loss is mainly
attributable to higher net finance income.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m.
(Eastern Time) tomorrow, Wednesday, August 15, 2012, to
discuss the 2012 second quarter results. Individuals interested in
participating in the live conference call by telephone may dial, in
Canada, 514-807-9895 or
647-427-7450, outside Canada,
888-231-8191. They may also listen through the Internet at
www.aezsinc.com in the "newsroom" section. A replay will be
available on the Company's website for 30 days following the live
event.
For reference, the Management's Discussion and Analysis
("MD&A") for the second quarter 2012 with the associated
Unaudited Interim Consolidated Financial Statements can be found at
www.aezsinc.com.
About Aeterna Zentaris Inc.
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. Securities
Litigation Reform Act of 1995. 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, 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
ability of the Company to take advantage of business opportunities
in the pharmaceutical industry, uncertainties related to the
regulatory process 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 relating to forward-looking
statements. Investors are cautioned not to rely 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, unless
required to do so by a governmental authority or by applicable
law.
Interim Consolidated Statements of Comprehensive Income
(Loss) Information
|
Three months ended
June 30, |
Six months ended
June 30, |
(in thousands, except for share and per share
data) |
2012 |
2011 |
2012 |
2011 |
|
$ |
$ |
$ |
$ |
Revenues |
|
|
|
|
Sales and royalties |
7,239 |
6,114 |
15,547 |
13,206 |
License fees and other |
232 |
409 |
1,434 |
706 |
|
7,471 |
6,523 |
16,981 |
13,912 |
|
|
|
|
|
Operating expenses |
|
|
|
|
Cost of sales |
6,262 |
5,497 |
13,775 |
11,520 |
Research and development costs, net of tax credits
and grants |
5,167 |
5,563 |
10,739 |
11,061 |
Selling, general and administrative expenses |
3,642 |
3,434 |
6,855 |
6,593 |
|
15,071 |
14,494 |
31,369 |
29,174 |
|
|
|
|
|
Loss from operations |
(7,600) |
(7,971) |
(14,388) |
(15,262) |
|
|
|
|
|
Finance income |
12,145 |
265 |
7,483 |
1,089 |
Finance costs |
(5) |
(2,863) |
(6) |
(5,612) |
Net finance income (costs) |
12,140 |
(2,598) |
7,477 |
(4,523) |
|
|
|
|
|
Income (loss) before income taxes |
4,540 |
(10,569) |
(6,911) |
(19,785) |
Income tax expense |
- |
- |
- |
(841) |
|
|
|
|
|
Net income (loss) |
4,540 |
(10,569) |
(6,911) |
(20,626) |
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
Foreign currency translation adjustments |
52 |
(526) |
(203) |
(1,865) |
|
|
|
|
|
Comprehensive income (loss) |
4,592 |
(11,095) |
(7,114) |
(22,491) |
|
|
|
|
|
Net income (loss) per share |
|
|
|
|
Basic and diluted |
0.04 |
(0.12) |
(0.06) |
(0.23) |
Weighted average number of shares
outstanding |
|
|
|
|
Basic |
111,058,138 |
90,690,019 |
108,537,490 |
88,721,832 |
|
|
|
|
|
Diluted |
111,059,815 |
90,690,019 |
108,537,490 |
88,721,832 |
Interim Consolidated Statement of Financial Position
Information
(in thousands) |
As at
June 30,
2012 |
As at
December 31,
2011 |
|
$ |
$ |
|
|
|
Cash and cash equivalents |
39,759 |
46,881 |
Trade and other receivables and other current
assets |
11,073 |
13,258 |
Restricted cash |
792 |
806 |
Property, plant and equipment |
2,223 |
2,512 |
Other non-current assets |
11,521 |
11,912 |
Total assets |
65,368 |
75,369 |
|
|
|
Payables and other current liabilities |
15,778 |
17,784 |
Long-term payable (current and non-current
portions) |
59 |
88 |
Warrant liability (current and non-current
portions) |
2,086 |
9,204 |
Non-financial non-current liabilities* |
49,267 |
52,839 |
Total liabilities |
67,190 |
79,915 |
Shareholders' deficiency |
(1,822) |
(4,546) |
Total liabilities and shareholders'
deficiency |
65,368 |
75,369 |
________________________
* Comprised mainly of non-current portion of deferred
revenues, employee future benefits and provision.
SOURCE AETERNA ZENTARIS INC.