[August 12, 2014] |
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Acceleron Pharma Reports Second Quarter 2014 Financial Results
CAMBRIDGE, Mass. --(Business Wire)--
Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical
company focused on the discovery, development and commercialization of
novel protein therapeutics for cancer and rare diseases, today provided
a corporate update and reported financial results for the second quarter
ended June 30, 2014.
"This has been a period of tremendous momentum at Acceleron with the
rapid progress and expansion of our clinical pipeline," said John Knopf,
Ph.D., Chief Executive Officer of Acceleron. "We presented encouraging
interim clinical data from five different ongoing phase 2 clinical
trials across all three of our clinical programs, in particular our
hematology programs partnered with Celgene. These results illustrate the
significant number of distinct opportunities in our pipeline to generate
clinically and commercially promising therapies and we look forward to
presenting additional exciting data at major medical conferences later
this year."
Recent Highlights and Current Updates
Clinical Development Programs
-
Positive interim data from phase 2 study of dalantercept in
combination with axitinib in renal cell carcinoma (RCC) presented at
ASCO - Acceleron presented encouraging safety and efficacy data
from the dose escalation stage of the ongoing phase 2 clinical trial
at the annual meeting of the American Society of Clinical Oncology
(ASCO) in June.
-
Initiation of the randomized, placebo-controlled stage of the
ongoing Phase 2 study of dalantercept in combination with axitinib in
RCC patients - The Company initiated the randomized,
placebo-controlled study (part 2) of dalantercept in combination with
axitinib versus placebo plus axitinib. The primary endpoint of part 2
of the trial will be progression-free survival.
-
Initiation of the Phase 1b study of dalantercept in hepatocellular
carcinoma (HCC) - Acceleron initiated a clinical trial of
dalantercept in combination with sorafenib, a VEGF antagonist approved
for treatment of advanced HCC, in first-line patients. The endpoint
for the study is safety, tolerability and a recommended dose for a
phase 2b study. Similar to the therapeutic strategy being used in the
renal cell carcinoma study, we believe the combination of a VEGFR TKI
plus dalantercept will more fully inhibit angiogenesis than just a
VEGF antagonist and thereby may provide a better clinical outcome for
patients.
-
Positive interim data showing increases in hemoglobin or reductions
in transfusion burden from the sotatercept and ACE-536 clinical trials
in beta-thalassemia and myelodysplastic syndromes (MDS) presented at
EHA - Acceleron and Celgene investigators gave three oral
presentations highlighting encouraging safety and efficacy data from
the sotatercept and ACE-536 clinical trials in beta thalassemia
patients and the ACE-536 clinical trial in MDS patients at the annual
meeting of the European Hematology Association (EHA) in June.
-
Early signs of activity from phase 2a study of sotatercept in
end-stage renal disease patients presented at two clinical meetings -
An interim analysis from an ongoing Phase 2a clinical trial of
sotatercept in end-stage renal disease patients on hemodialysis
indicated that sotatercept produced dose dependent increases in
hemoglobin. These data were presented at the National Kidney
Foundation Spring Clinical Meeting and at the European Renal
Association - European Dialysis Transplantation Association annual
meeting.
-
ACE-536 granted orphan designation by EMA (News - Alert) - The European
Medicines Association (EMA) granted orphan designation to ACE-536 for
the treatment of beta-thalassemia patients and myelodysplastic
syndromes patients. Collectively, FDA orphan designation has been
granted for both sotatercept and ACE-536 for MDS and beta-thalassemia
and EMA orphan designation has been granted for ACE-536 for MDS and
beta-thalassemia.
-
ACE-536 nonproprietary name is luspatercept - The United States
Adopted Names (USAN (News - Alert)) Council has approved the name "luspatercept" for
ACE-536 and we expect the World Health Organization's International
Nonproprietary Name (INN) group to also approve the name in the near
future.
-
Positive preclinical data with ACE-536 in a murine model of sickle
cell disease presented at EHA - Acceleron scientists presented
data in a mouse model of sickle cell disease. Following one month of
treatment, RAP-536 (murine version of ACE-536) significantly increased
red blood cell (RBC) number and hemoglobin compared to placebo
treatment in sickle cell disease (SCD) mice. Other clinically
important parameters improved, such as a decrease in number of
reticulocytes and irreversibly sickled cells. Sickle cell disease,
like beta-thalassemia, is a hemoglobinopathy, a category of red blood
cell diseases, which is among the most common inherited diseases.
Other Business Highlights
-
Antibody discovery collaboration with Adimab - Acceleron
continues to leverage its unique understanding of the importance and
therapeutic potential of the TGF-ß superfamily to create new product
candidates. To this end, Acceleron and Adimab have signed a
multi-target antibody discovery collaboration against targets selected
by Acceleron. Acceleron has the worldwide rights to develop and
commercialize antibodies resulting from the collaboration.
Upcoming Milestones
-
Interim data from sotatercept phase 2a clinical trial in end-stage
renal disease patients at ASN - Acceleron's collaboration partner
Celgene intends to present additional interim data at the annual
meeting of the American Society of Nephrology (ASN) in November.
-
Interim data from sotatercept and ACE-536 phase 2 clinical trials
in beta-thalassemia and MDS patients at ASH - Acceleron and
Celgene intend to present additional interim data at the annual
meeting of the American Society of Hematology (ASH) in December for
these programs in patients with beta-thalassemia and MDS.
-
Initiation of a phase 1 clinical trial with ACE-083 - Acceleron
is conducting development activities in preparation for the submission
of an Investigational New Drug (IND) application for its clinical
candidate ACE-083, a locally acting protein therapeutic designed to
increase muscle mass and strength. Acceleron plans to initiate a phase
1 clinical trial in the second half of 2014.
Financial Results
-
Cash Position - Cash and cash equivalents as of June 30, 2014
were $204.3 million. Acceleron expects that its cash and cash
equivalents balance as of June 30, 2014, will be sufficient to fund
the Company's operations into the second half of 2017.
-
Revenue - Collaboration revenue was $4.1 million for the second
quarter of 2014 compared to $26.4 million for the comparable period in
2013. The decrease for the second quarter of 2014 compared to the
comparable period in 2013 was driven by recognition of $22.8 million
of deferred revenue resulting from termination of the ACE-031
collaboration agreement in June 2013.
-
R&D Expenses - Research and development expenses were $12.7
million in the second quarter of 2014, compared to $8.9 million in the
same period in 2013. This $3.8 million increase was primarily due to
increases in direct program expenses.
-
Litigation settlement - In the three months ended June 30, 2014
we recorded $5.0 million as a condition of a settlement with the Salk
Institute for Biological Studies compared to zero in the same period
in 2013.
-
G&A Expenses - General and administrative expenses were
$3.7 million in the second quarter of 2014, compared to $3.4 million
for the same period in 2013.
-
Net Loss - Our net loss was $16.6 million for the second
quarter of 2014, compared to a net gain of $13.1 million for the
comparable periods in 2013. The second quarter of 2014 results were
affected by a gain of $0.7 million associated with marking to market
warrants to purchase of common stock, which are treated as
liabilities, as a result of the value of the warrants declining
between March 31, 2014 and June 30, 2014 primarily due to the change
in the Company's common stock price during that period. The second
quarter 2013 net income of $13.1 million resulted primarily from
recognition of $22.8 million of deferred revenue resulting from with
the termination of the ACE-031 deal with Shire during that quarter.
Conference Call, Webcast and Prepared Statement Information
The company will host a conference call and live audio webcast to report
its first quarter financial results for 2014 and provide a corporate
update on August 12, 2014, at 8:30 AM EDT. To participate by
teleconference, please dial 877- 312-5848 (domestic) or 253-237-1155
(international) and refer to the "Acceleron Q2 Earnings Call." To access
the live webcast and read the Company's prepared statement for this
earnings call, please select "Events & Presentations" in the Investors &
Media section on the Company's website (www.acceleronpharma.com).
To ensure a timely connection, it is recommended that users register at
least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be archived on the Company's website and
accessible approximately two hours after the event.
About Acceleron
Acceleron is a clinical stage biopharmaceutical company focused on the
discovery, development and commercialization of novel protein
therapeutics for cancer and rare diseases. The company is a leader in
understanding the biology of the Transforming Growth Factor-Beta (TGF-ß)
protein superfamily, a large and diverse group of molecules that are key
regulators in the growth and repair of tissues throughout the human
body, and in targeting these pathways to develop important new
medicines. Acceleron has built a highly productive R&D platform that has
generated innovative clinical and preclinical protein therapeutic
candidates with novel mechanisms of action. These protein therapeutic
candidates have the potential to significantly improve clinical outcomes
for patients with cancer and rare diseases.
For more information, please visit www.acceleronpharma.com.
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ACCELERON PHARMA INC. CONDENSED CONSOLIDATED
BALANCE SHEET (Amounts in thousands) (unaudited)
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|
|
|
|
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June 30, 2014
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December 31, 2013
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Cash and cash equivalents
|
|
|
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$
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204,250
|
|
|
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$
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113,163
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Other assets
|
|
|
|
10,394
|
|
|
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10,569
|
Total assets
|
|
|
|
$
|
214,644
|
|
|
|
$
|
123,732
|
|
|
|
|
|
|
|
|
|
Accrued expenses
|
|
|
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11,475
|
|
|
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6,927
|
Notes payable, net of discount
|
|
|
|
-
|
|
|
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16,868
|
Deferred revenue
|
|
|
|
6,629
|
|
|
|
7,651
|
Warrants to purchase common stock
|
|
|
|
21,512
|
|
|
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30,753
|
Other liabilities
|
|
|
|
5,201
|
|
|
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3,721
|
Total liabilities
|
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|
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44,817
|
|
|
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65,920
|
Total stockholders' equity
|
|
|
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169,827
|
|
|
|
57,812
|
Total liabilities and stockholders' equity
|
|
|
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$
|
214,644
|
|
|
|
$
|
123,732
|
|
|
|
|
|
|
|
|
|
|
|
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts
in thousands except per share data)
|
|
(unaudited)
|
|
|
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Three Months Ended June 30,
|
|
|
|
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2014
|
|
2013
|
Collaboration revenue
|
|
|
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4,078
|
|
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26,427
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
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Research and development
|
|
|
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12,677
|
|
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8,911
|
|
Litigation settlement
|
|
|
|
5,000
|
|
|
-
|
|
General and administrative
|
|
|
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3,712
|
|
|
3,365
|
|
Total costs and expenses
|
|
|
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21,389
|
|
|
12,276
|
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(Loss) income from operations
|
|
|
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(17,311
|
)
|
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14,151
|
|
Other income (expense), net
|
|
|
|
761
|
|
|
(1,073
|
)
|
Net (loss) income
|
|
|
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$
|
(16,550
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)
|
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$
|
13,078
|
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Accretion of dividends, interest, redemption value and issuance
costs on redeemable convertible preferred stock
|
|
|
|
-
|
|
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(6,843
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)
|
Net (loss) income applicable to participating securities
|
|
|
|
-
|
|
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(5,492
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)
|
Net (loss) income applicable to common stockholders-basic
|
|
|
|
$
|
(16,550
|
)
|
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$
|
743
|
|
Net (loss) income per share applicable to common stockholders:
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
|
|
$
|
(16,550
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)
|
|
$
|
13,078
|
|
Accretion of dividends, interest, redemption value and issuance
costs on redeemable convertible preferred stock
|
|
|
|
-
|
|
|
(6,843
|
)
|
Net (loss) income applicable to participating securities
|
|
|
|
-
|
|
|
(5,000
|
)
|
Net (loss) income applicable to common stockholders-diluted
|
|
|
|
$
|
(16,550
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)
|
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$
|
1,235
|
|
Net (loss) income per share applicable to common stockholders- basic
and diluted:
|
|
|
|
|
|
|
|
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Basic
|
|
|
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$
|
(0.52
|
)
|
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$
|
0.30
|
|
Diluted
|
|
|
|
$
|
(0.52
|
)
|
|
$
|
0.28
|
|
Weighted-average number of common shares used in computing net
(loss) income per share applicable to common stockholders:
|
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|
|
|
|
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Basic
|
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31,552
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2,438
|
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Diluted
|
|
|
|
31,552
|
|
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4,457
|
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|
|
|
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|
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Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements about the
Company's strategy, future plans and prospects, including statements
regarding the development of the Company's compounds, including
sotatercept, ACE-536, dalantercept, or ACE-083 and the Company's TGF-ß
superfamily program generally, the timeline for clinical development and
regulatory approval of the Company's compounds, the expected timing for
the reporting of data from ongoing trials, and the structure of the
Company's planned or pending clinical trials. The words "anticipate,"
"appear," "believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "will," "would," "could,"
"should," "continue," and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. Each forward-looking statement is
subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks that the Company's
cash position will be insufficient to fund operations into the second
half of 2017, that preclinical testing of the Company's compounds and
preliminary data from clinical trials may not be predictive of the
results or success of ongoing or later clinical trials, that data may
not be available when we expect it to be, that the Company or its
collaboration partner, Celgene, will be unable to successfully complete
the clinical development of its compounds, that the development of the
Company's compounds will take longer or cost more than planned, that the
Company may be delayed in initiating or completing any clinical trials,
and that the Company's compounds will not receive regulatory approval or
become commercially successful products. Other risks and uncertainties
include those identified under the heading "Risk Factors" included in
the Company's Registration Statement on Form 10-K which was filed with
the Securities and Exchange Commission (SEC (News - Alert)) on March 17, 2014, and
other filings that the Company may make with the SEC in the future. The
forward-looking statements contained in this press release reflect the
Company's current views with respect to future events, and the Company
does not undertake and specifically disclaims any obligation to update
any forward-looking statements.
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