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 second quarter ended June 30, 2020.
"Acceleron had another productive quarter marked by additional regulatory approvals of REBLOZYL in the U.S. and E.U., strong product uptake resulting in subsequent royalty revenues, and multiple important updates for our lead program in pulmonary disease," said Habib Dable, President and Chief Executive Officer of Acceleron. "Alongside our global collaboration partner, Bristol Myers Squibb, the U.S. commercial launch of REBLOZYL is off to a great start in only its second full quarter since we received our first approval late last year. We also continue to make progress in evaluating additional patient populations in which this erythroid maturation agent could potentially reduce or eliminate red blood cell transfusion burden in patients with anemia-related blood disorders."
Added Mr. Dable: "Beyond our hematology franchise, we continue to make significant progress in advancing our pulmonary program in pulmonary arterial hypertension. Recently, we presented positive topline results from the Phase 2 PULSAR trial at the country's premiere thoracic medical meeting, ATS 2020. In early October, we look forward to hosting a call to discuss the trial design for our first planned registrational trial, called STELLAR, which we expect to initiate by year-end. Our future development plan will support our long-term vision for sotatercept to become a backbone therapy for patients with PAH across all stages of disease."
Program Highlights
Hematology
REBLOZYL (luspatercept-aamt): Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)
REBLOZYL is the first and only approved erythroid maturation agent designed to promote red blood cell (RBC) production. Luspatercept is also being developed for the treatment of anemia in additional patient populations of MDS, beta-thalassemia, and MF. REBLOZYL is part of the global collaboration between Acceleron and Bristol Myers Squibb.
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 studies of PAH, sotatercept (RAP-011) reversed pulmonary vessel muscularization and improved indicators of right heart failure.
Corporate Highlights
Financial Results
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its second quarter 2020 financial results and provide an update on recent corporate activities on August 6, 2020, at 5:00 p.m. EDT.
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 Second 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 and Europe 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 the United States 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, having recently reported positive topline results of the Phase 2 PULSAR trial.
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) |
||||||||
|
June 30, 2020 |
|
December 31, 2019 |
|||||
Cash and cash equivalents |
$ |
283,521 |
|
|
$ |
237,677 |
|
|
Short and long-term investments |
106,289 |
|
|
216,169 |
|
|||
Operating lease - right of use asset, net |
21,116 |
|
|
23,908 |
|
|||
Other assets |
68,509 |
|
|
27,152 |
|
|||
Total assets |
$ |
479,435 |
|
|
$ |
504,906 |
|
|
|
|
|
|
|||||
Operating lease liability - right of use, short-term and long-term |
$ |
23,407 |
|
|
$ |
26,384 |
|
|
Warrants to purchase common stock |
3,516 |
|
|
1,856 |
|
|||
Other liabilities |
30,893 |
|
|
27,190 |
|
|||
Total liabilities |
57,816 |
|
|
55,430 |
|
|||
Total stockholders' equity |
421,619 |
|
|
449,476 |
|
|||
Total liabilities and stockholders' equity |
$ |
479,435 |
|
|
$ |
504,906 |
|
ACCELERON PHARMA INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands except per share data) (unaudited) |
||||||||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|||||||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||||||
Revenue: |
|
|
|
|
|
|
|
|||||||||||||
Collaboration revenue |
$ |
39,752 |
|
|
|
$ |
27,666 |
|
|
|
$ |
44,096 |
|
|
|
$ |
30,447 |
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|||||||||||||
Research and development |
38,251 |
|
|
|
34,765 |
|
|
|
75,917 |
|
|
|
67,536 |
|
|
|||||
Selling, general and administrative |
20,414 |
|
|
|
14,037 |
|
|
|
38,663 |
|
|
|
24,851 |
|
|
|||||
Total costs and expenses |
58,665 |
|
|
|
48,802 |
|
|
|
114,580 |
|
|
|
92,387 |
|
|
|||||
Loss from operations |
(18,913 |
) |
|
|
(21,136 |
) |
|
|
(70,484 |
) |
|
|
(61,940 |
) |
|
|||||
Other income, net |
466 |
|
|
|
3,230 |
|
|
|
1,113 |
|
|
|
6,003 |
|
|
|||||
Loss before income taxes |
(18,447 |
) |
|
|
(17,906 |
) |
|
|
(69,371 |
) |
|
|
(55,937 |
) |
|
|||||
Income tax (provision) benefit |
(4 |
) |
|
|
44 |
|
|
|
(20 |
) |
|
|
24 |
|
|
|||||
Net loss |
$ |
(18,451 |
) |
|
|
$ |
(17,862 |
) |
|
|
$ |
(69,391 |
) |
|
|
$ |
(55,913 |
) |
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net loss per share- basic and diluted |
$ |
(0.34 |
) |
|
|
$ |
(0.34 |
) |
|
|
$ |
(1.29 |
) |
|
|
$ |
(1.08 |
) |
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Weighted-average number of common shares used in computing net loss per share- basic and diluted |
53,860 |
|
|
|
52,689 |
|
|
|
53,610 |
|
|
|
51,912 |
|
|
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.
These press releases may also interest you
|