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Acceleron Announces Fourth Quarter and Full Year 2020 REBLOZYL® Net Sales

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Acceleron Pharma (Nasdaq:XLRN) reported Q4 2020 net sales of REBLOZYL at approximately $115 million, achieving total annual sales of $274 million. The company expects royalty revenue of $23 million for Q4, up from $19.3 million in Q3, leading to an estimated $54.8 million in total royalty revenue for 2020. Preliminary revenue estimates are subject to finalization and audit procedures, and thus may change. Acceleron remains focused on developing treatments for serious diseases, highlighting potential Phase 3 trials for its pulmonary candidate, sotatercept.

Positive
  • Q4 2020 net sales of REBLOZYL reached approximately $115 million.
  • Royalty revenue for Q4 2020 is expected to be $23 million, a notable increase from Q3 2020.
  • Total expected royalty revenue for 2020 is approximately $54.8 million.
  • Positive topline results reported from the PULSAR Phase 2 trial for sotatercept.
Negative
  • Preliminary revenue estimates are subject to adjustments, which could materially alter financial outcomes.
  • Risks associated with the success of clinical trials and regulatory approvals remain.

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 announced net sales of REBLOZYL® (luspatercept-aamt) as reported by its global collaborator, Bristol Myers Squibb, were approximately $115 million for the fourth quarter and approximately $274 million for the full year ended December 31, 2020.

Acceleron expects to report royalty revenue of approximately $23.0 million from net sales of REBLOZYL in the fourth quarter ended December 31, 2020. This compares with approximately $19.3 million in royalty revenue from approximately $96 million of net sales of REBLOZYL for the third quarter ended September 30, 2020. For the full year 2020, Acceleron expects to report royalty revenue of approximately $54.8 million.

The preliminary unaudited revenue estimates for the quarter and full year ended December 31, 2020 included in this release are the responsibility of management and are subject to the completion of the Company’s customary quarter and year-end financial closing procedures, including management’s review and finalization, as well as audit procedures by the Company’s independent registered public accounting firm, which have not yet been completed. During the course of the Company’s review process, items may be identified that would require it to make adjustments, which could result in material changes to the Company’s preliminary unaudited estimated financial results. Consequently, these revenue estimates should not be viewed as substitutes for the Company’s earnings release and Annual Report on Form 10-K.

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 arterial hypertension (PAH), having reported 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. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) this year.

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.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements about the Company's financial results. 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.

FAQ

What were Acceleron Pharma's Q4 2020 net sales?

Acceleron Pharma reported approximately $115 million in Q4 2020 net sales of REBLOZYL.

How much royalty revenue did Acceleron expect for Q4 2020?

Acceleron expects to report approximately $23 million in royalty revenue for Q4 2020.

What are the total estimated sales for REBLOZYL in 2020?

The total estimated sales for REBLOZYL in 2020 were approximately $274 million.

What clinical trials is Acceleron planning for sotatercept?

Acceleron is planning multiple Phase 3 trials for sotatercept for treating pulmonary arterial hypertension.

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