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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Acceleron Pharma Inc | NASDAQ:XLRN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 178.75 | 179.92 | 179.91 | 0 | 01:00:00 |
- Highlighted ongoing and planned trials in rare pulmonary diseases and presented vision and strategy for long-term growth at June R&D Day -
- Updates from the PULSAR and SPECTRA Phase 2 trials of sotatercept in patients with pulmonary arterial hypertension (PAH) presented at the American Thoracic Society (ATS) 2021 International Conference -
- Acceleron recognized approximately $25.6 million in royalty revenue for Q2 2021 from approximately $128 million in net sales of REBLOZYL® (luspatercept-aamt) -
- First results from BEYOND Phase 2 trial of luspatercept in adult patients with non-transfusion-dependent beta-thalassemia presented at the European Hematology Association (EHA) 2021 Virtual Congress during Presidential Symposium -
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 reported financial results for the second quarter ended June 30, 2021.
“We were very pleased to highlight clinical updates from the PULSAR and SPECTRA Phase 2 trials of sotatercept reported at the annual ATS medical meeting and outline our plans for future long-term growth in rare pulmonary diseases at our Research & Development Day during the second quarter,” said Habib Dable, President and Chief Executive Officer of Acceleron. “Beyond our sotatercept clinical program in pulmonary arterial hypertension, most recently, we announced plans to expand the development of sotatercept into a Phase 2 trial in patients with Group 2 pulmonary hypertension and develop ACE-1334 in systemic sclerosis-associated interstitial lung disease. To date, our pulmonary pipeline has grown to include seven ongoing and planned clinical trials, showcasing our long-term commitment to becoming a global leader in rare pulmonary disease.”
Added Mr. Dable: “With respect to our hematology program, along with our commercial partner Bristol-Myers Squibb Company (Bristol Myers Squibb), we continue to be pleased with product uptake. Our joint commercial teams are presently focused on expanding the reach to appropriate patients earlier in their MDS journey—where there is particular demand—along with the optimal dose of REBLOZYL to maximize patient benefit and increased duration of treatment in this population to drive further growth this year and beyond. In June, we presented results from the BEYOND Phase 2 trial of luspatercept during the Presidential Symposium at EHA. The study achieved its primary endpoint of an increase in hemoglobin of at least 1 gram per deciliter in the luspatercept treated group compared to placebo for the treatment of anemia in adults with non-transfusion dependent beta-thalassemia, supporting the rationale for its potential development in additional patient groups.”
Program Highlights
Pulmonary
Sotatercept: Pulmonary Hypertension Sotatercept acts as an investigational reverse-remodeling agent proposed to rebalance TGF-beta superfamily signaling. In preclinical models of PAH, sotatercept reversed pulmonary arterial wall and right ventricular remodeling that are hallmarks of the disease.
ACE-1334: Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) ACE-1334 is an Acceleron-discovered, TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands but not TGF-beta 2. ACE-1334 has shown robust anti-fibrotic activity in multiple preclinical models of fibrosis.
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.
Corporate Highlights
Financial Results
Non-GAAP Financial Measures
Acceleron supplements its results of operations prepared in accordance with U.S. generally accepted accounting principles, or GAAP, with certain non-GAAP financial measures, including non-GAAP R&D expense, non-GAAP SG&A expense, adjusted net loss and adjusted net loss per share, that exclude stock-based compensation expense and depreciation and amortization expense. These results should not be viewed as a substitute for the Company’s GAAP results and are provided as a complement to results provided in accordance with GAAP. Management believes these non-GAAP financial measures provide investors with additional insight into underlying trends of the Company's ongoing business, and are important in comparing current results with prior period results. Investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures. In addition, other companies may report similarly titled non-GAAP measures, but calculate them differently, which reduces their usefulness as a comparative measure. In the reconciliation tables below, Acceleron presents these non-GAAP financial measures reconciled to their comparable GAAP financial measures.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its second quarter 2021 financial results on August 5, 2021, 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 www.acceleronpharma.com. To participate in the conference call, please dial 833-494-1483 (domestic) or 236-714-2620 (international) and reference code #5736809.
An archived version of the webcast will be available for replay on the Company's website for approximately one year.
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 research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary hypertension (PH). Following positive PULSAR Phase 2 results, Acceleron is executing on its Phase 3 development plan to support its long-term vision of establishing sotatercept as a backbone therapy for patients with pulmonary arterial hypertension (PAH) at all stages of the disease. Acceleron is also expanding the development of sotatercept into Group 2 PH, with the CADENCE Phase 2 trial expected to initiate this year. Acceleron has expanded its rare pulmonary disease pipeline and is investigating the potential of ACE-1334 in a Phase 1b/Phase 2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD).
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 the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis.
For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.
ACCELERON PHARMA INC.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
(unaudited)
June 30, 2021
December 31, 2020
Cash and cash equivalents
$
336,199
$
670,952
Short and long-term investments
376,345
186,536
Operating lease - right of use asset, net
18,799
21,988
Other assets
104,709
52,861
Total assets
$
836,052
$
932,337
Operating lease liability - right of use, short-term and long-term
$
20,719
$
24,077
Other liabilities
52,299
53,153
Total liabilities
73,018
77,230
Total stockholders’ equity
763,034
855,107
Total liabilities and stockholders’ equity
$
836,052
$
932,337
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,
2021
2020
2021
2020
Revenue:
Collaboration revenue
$
27,940
$
39,752
$
52,698
$
44,096
Costs and expenses:
Research and development
56,130
38,251
113,429
75,917
Selling, general and administrative
35,472
20,414
66,534
38,663
Total costs and expenses
91,602
58,665
179,963
114,580
Loss from operations
(63,662)
(18,913)
(127,265)
(70,484)
Other income, net
149
466
286
1,113
Loss before income taxes
(63,513)
(18,447)
(126,979)
(69,371)
Income tax provision
(8)
(4)
(13)
(20)
Net loss
$
(63,521)
$
(18,451)
$
(126,992)
$
(69,391)
Net loss per share- basic and diluted
$
(1.05)
$
(0.34)
$
(2.10)
$
(1.29)
Weighted-average number of common shares used in computing net loss per share- basic and diluted
60,724
53,860
60,524
53,610
ACCELERON PHARMA INC.
RECONCILIATION OF GAAP TO NON-GAAP COSTS and EXPENSES
(Amounts in thousands)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
GAAP research and development
$
56,130
$
38,251
$
113,429
$
75,917
Less adjustments:
Stock-based compensation
5,876
3,259
14,032
6,400
Depreciation and amortization
935
871
1,871
1,803
Non-GAAP research and development
$
49,319
$
34,121
$
97,526
$
67,714
GAAP selling, general and administrative
$
35,472
$
20,414
$
66,534
$
38,663
Less adjustments:
Stock-based compensation
7,603
3,881
15,073
7,419
Depreciation and amortization
100
72
191
135
Non-GAAP selling, general and administrative
$
27,769
$
16,461
$
51,270
$
31,109
ACCELERON PHARMA INC.
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET LOSS AND NET LOSS PER SHARE
(Amounts in thousands except per share data)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2021
2020
2021
2020
GAAP net loss
$
(63,521)
$
(18,451)
$
(126,992)
$
(69,391)
Adjustments:
Stock-based compensation
13,479
7,140
29,105
13,819
Depreciation and amortization
1,036
943
2,062
1,938
Adjusted net loss (non-GAAP)
$
(49,006)
$
(10,368)
$
(95,825)
$
(53,634)
GAAP net loss per share- basic and diluted
$
(1.05)
$
(0.34)
$
(2.10)
$
(1.29)
Adjustments:
Stock-based compensation
0.22
0.13
0.48
0.26
Depreciation and amortization
0.02
0.02
0.03
0.04
Adjusted net loss per share (non-GAAP)
$
(0.81)
$
(0.19)
$
(1.59)
$
(0.99)
Weighted-average number of common shares used in computing net loss per share
60,724
53,860
60,524
53,610
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 Company (“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 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/20210805005947/en/
Acceleron Pharma Inc. Investors: Jamie Bernard, IRC, 617-301-9650 Associate Director, Investor Relations
Media: Matt Fearer, 617-301-9557 Senior Director, Corporate Communications
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