- Acceleron recognized approximately $19.3
million in royalty revenue for Q3 2020 from approximately $96
million in net sales of REBLOZYL® (luspatercept-aamt) -
- REBLOZYL, the first and only erythroid
maturation agent, was approved by Health Canada for the treatment
of transfusion-dependent anemia in adults with beta-thalassemia
-
- Registrational STELLAR Phase 3 trial of
sotatercept in patients with pulmonary arterial hypertension (PAH)
on track to initiate by year-end 2020 -
Acceleron Pharma Inc. (Nasdaq:XLRN), a biopharmaceutical company
dedicated to the discovery, development, and commercialization of
TGF-beta superfamily therapeutics to treat serious and rare
diseases, today provided a corporate update and reported financial
results for the third quarter ended September 30, 2020.
“Acceleron has made significant progress this year with
continued market expansion and adoption of REBLOZYL, and the
finalization of the global regulatory path for sotatercept in PAH,”
said Habib Dable, President and Chief Executive Officer of
Acceleron. “Months into the commercial launch of REBLOZYL, we and
our partner Bristol Myers Squibb continue to see strong product
uptake in the U.S. along with initial sales contributions from the
recent availability of REBLOZYL in certain E.U. countries. Adding
to the momentum, we successfully expanded the global reach of
REBLOZYL with its recent approval by Health Canada.”
Added Mr. Dable: “As our hematology franchise continues to grow,
we are advancing our pulmonary program, with a primary focus in
PAH. Encouraged by the impressive topline results from our PULSAR
Phase 2 trial, we look forward to multiple presentations on
sotatercept at the upcoming virtual meeting of the AHA 2020
Scientific Sessions next week as our team is preparing to initiate
our registrational Phase 3 trial, called STELLAR.”
Program Highlights
Hematology
REBLOZYL
(luspatercept-aamt):
REBLOZYL is the first and only approved erythroid maturation
agent designed to promote late-stage red blood cell (RBC)
production. REBLOZYL is part of the global collaboration between
Acceleron and Bristol Myers Squibb.
- Commercial Launch of REBLOZYL:
- The Company recognized approximately $19.3 million in royalty
revenue from approximately $96 million in net sales of REBLOZYL in
the third quarter of 2020. This compares with approximately $11.1
million in royalty revenue from approximately $55 million in net
sales of REBLOZYL in the second quarter of 2020.
- Regulatory:
- In September, Acceleron and partner Bristol Myers Squibb
announced that Health Canada approved REBLOZYL for the treatment of
adult patients with red blood cell transfusion-dependent anemia
associated with beta(β)-thalassemia.
Pulmonary
Sotatercept: Pulmonary Arterial
Hypertension (PAH)
Sotatercept is an investigational agent designed to be a
selective ligand trap for members of the TGF-beta superfamily to
rebalance BMPR2 signaling, which is a key molecular driver of PAH.
In preclinical research published in Science Translational
Medicine, sotatercept (RAP-011) reversed pulmonary vessel
muscularization and improved indicators of right heart failure in
models of PAH.
- In October, the Company highlighted the trial design for its
upcoming registrational STELLAR Phase 3 trial in patients with PAH,
which it plans to initiate by year-end 2020.
- The Company plans to present the 24-week echocardiography
results from the PULSAR Phase 2 trial at the virtual 2020 American
Heart Association (AHA) Scientific Sessions taking place November
13-17. In addition, preliminary interim results from the SPECTRA
Phase 2 trial will be presented at the congress.
- Results from the open-label extension period of the PULSAR
Phase 2 trial and additional results from the ongoing SPECTRA Phase
2 trial are expected in the first half of 2021.
- The Company expects to initiate the HYPERION (early
intervention) Phase 3 trial and the ZENITH (later intervention)
Phase 3 trial in expanded PAH populations in the middle of
2021.
Corporate Highlights
- In July, Acceleron closed a follow-on public offering of common
stock, including the full exercise of the underwriters’ option to
purchase additional shares, for net proceeds of $492.4
million.
- In September, Laura J. Hamill was appointed to the Board of
Directors. Ms. Hamill has more than three decades of experience in
the biopharma industry.
Financial Results
- Cash Position - Cash, cash equivalents and investments
as of September 30, 2020 were $887.4 million, compared with $453.8
million as of December 31, 2019. Based on Acceleron's current
operating plan and projections, the Company believes that its
current cash, cash equivalents and investments, along with the
expected royalty revenue from REBLOZYL sales, will be sufficient to
fund the Company’s projected operating requirements for the
foreseeable future.
- Revenue - Revenue for the third quarter of 2020 was
$22.6 million, which includes $3.3 million of cost share revenue
and $19.3 million of royalty revenue from net sales of REBLOZYL.
All revenue was derived from the Company's partnership with Bristol
Myers Squibb.
- Costs and Expenses - Total costs and expenses for the
third quarter of 2020 were $61.8 million. This includes R&D
expenses of $40.8 million and SG&A expenses of $21.0
million.
- Net Loss - The Company's net loss for the third quarter
of 2020 was $39.2 million.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss
its third quarter 2020 financial results and provide an update on
recent corporate activities on November 5, 2020, at 5:00 p.m.
EST.
The webcast will be accessible under "Events &
Presentations" in the Investors & Media page of the Company’s
website at acceleronpharma.com.
Individuals can participate in the conference call by dialing
877-312-5848 (domestic) or 253-237-1155 (international) and
referring to the “Acceleron Third Quarter 2020 Earnings Call.”
The archived webcast will be available for replay on the
Acceleron website approximately two hours after the event.
About Acceleron
Acceleron is a biopharmaceutical company dedicated to the
discovery, development, and commercialization of therapeutics to
treat serious and rare diseases. Acceleron’s leadership in the
understanding of TGF-beta superfamily biology and protein
engineering generates innovative compounds that engage the body's
ability to regulate cellular growth and repair.
Acceleron focuses its commercialization, research, and
development efforts in hematologic and pulmonary diseases. In
hematology, REBLOZYL® (luspatercept-aamt) is the first and only
erythroid maturation agent approved in the United States, Europe,
and Canada for the treatment of anemia in certain blood disorders.
REBLOZYL is part of a global collaboration partnership with Bristol
Myers Squibb. The Companies co-promote REBLOZYL in North America
and are also developing luspatercept for the treatment of anemia in
patient populations of MDS, beta-thalassemia, and myelofibrosis. In
pulmonary, Acceleron is developing sotatercept for the treatment of
pulmonary arterial hypertension (PAH), having recently presented
positive topline results of the PULSAR Phase 2 trial. The Company
is currently planning multiple Phase 3 trials with the potential to
support its long-term vision of establishing sotatercept as a
backbone therapy for patients with PAH at all stages of the
disease.
For more information, please visit acceleronpharma.com. Follow Acceleron on social
media: @AcceleronPharma and
LinkedIn.
ACCELERON PHARMA INC.
CONDENSED CONSOLIDATED BALANCE
SHEET
(Amounts in thousands)
(unaudited)
September 30, 2020
December 31, 2019
Cash and cash equivalents
$
729,685
$
237,677
Short and long-term investments
157,676
216,169
Operating lease - right of use asset,
net
19,660
23,908
Other assets
40,744
27,152
Total assets
$
947,765
$
504,906
Operating lease liability - right of use,
short-term and long-term
$
21,851
$
26,384
Warrants to purchase common stock
—
1,856
Other liabilities
30,778
27,190
Total liabilities
52,629
55,430
Total stockholders’ equity
895,136
449,476
Total liabilities and stockholders’
equity
$
947,765
$
504,906
ACCELERON PHARMA INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Amounts in thousands except
per share data)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
Revenue:
Collaboration revenue
$
22,561
$
4,208
$
66,656
$
34,655
Costs and expenses:
Research and development
40,747
37,630
116,663
105,125
Selling, general and administrative
21,042
15,501
59,705
40,394
Total costs and expenses
61,789
53,131
176,368
145,519
Loss from operations
(39,228
)
(48,923
)
(109,712
)
(110,864
)
Other (expense), income net
(6
)
3,520
1,108
9,523
Loss before income taxes
(39,234
)
(45,403
)
(108,604
)
(101,341
)
Income tax (provision) benefit
(11
)
34
(31
)
58
Net loss
$
(39,245
)
$
(45,369
)
$
(108,635
)
$
(101,283
)
Net loss per share- basic and diluted
$
(0.66
)
$
(0.86
)
$
(1.95
)
$
(1.94
)
Weighted-average number of common shares
used in computing net loss per share- basic and diluted
59,640
52,882
55,635
52,239
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements about the
Company's strategy, future plans and prospects, including
statements regarding the development and commercialization of the
Company's compounds, the timeline for clinical development and
regulatory approval of the Company's compounds, the expected timing
for reporting of data from ongoing clinical trials, the Company's
future cash position and the potential of REBLOZYL®
(luspatercept-aamt) as a therapeutic drug. The words "anticipate,"
"believe," "could," "estimate," "expect," "goal," "intend," "may,"
"plan," "potential," "project," "should," "target," "will,"
"would," and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to, that preclinical
testing of the Company's compounds and data from clinical trials
may not be predictive of the results or success of other clinical
trials, that regulatory approval of the Company’s compounds in one
indication or country may not be predictive of approval in another
indication or country, that the development of the Company’s
compounds may take longer and/or cost more than planned or
accelerate faster than currently expected, that the Company or its
collaboration partner, Bristol Myers Squibb (“BMS”), may be unable
to successfully complete the clinical development of the Company’s
compounds, that the Company or BMS may be delayed in initiating,
enrolling or completing any clinical trials, and that the Company’s
compounds may not receive regulatory approval or become
commercially successful products. These and other risks and
uncertainties are identified under the heading “Risk Factors”
included in the Company’s most recent Annual Report on Form 10-K,
Quarterly Report on Form 10-Q, and other filings that the Company
has made and may make with the SEC in the future.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and the
Company does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005936/en/
Acceleron Pharma Inc. Investors: Jamie Bernard, IRC,
617-649-9650 Associate Director, Investor Relations
Media: Matt Fearer, 617-301-9557 Director, Corporate
Communications
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