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What You'll Want to Know About Acceleron Pharma's Q2 Update

By Keith Speights – Aug 6, 2019 at 6:00AM

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The big story for Acceleron: waiting on good news for luspatercept.

Acceleron Pharma (XLRN) hasn't generated much excitement for investors so far this year. The stock is down close to 5% year to date while the broader market indexes are up solidly.

The biotech reported its second-quarter financial results after the market closed on Monday. Was there anything for investors to get excited about? Here's what you need to know about the Acceleron's Q2 update.

Scientist looking at a slide through a microscope

Image source: Getty Images

By the numbers

Acceleron reported that its revenue for the second quarter increased by nearly 649% year-over-year to $27.7 million. Wall Street analysts expected revenue to come in at $26.14 million.

The company announced a net loss of $17.9 million, or $0.34 per share, on a generally accepted accounting principles (GAAP) basis, compared to a loss of $28.9 million, or $0.63 per share, in the same period in 2018. The average analysts' estimate projected a Q2 net loss of $0.03 per share.

Acceleron ended the second quarter with cash, cash equivalents, and short-term investments of $500.9 million. This was an increase from the $291.3 million on hand as of the end of 2018.

Behind the numbers

Were any of these financial figures particularly exciting for investors? Nope. The best news for Acceleron was that it's in good shape from a cash standpoint, but that wasn't unexpected -- especially after the company received a $25 million milestone payment from Celgene related to luspatercept.

This milestone payment made a big difference in Acceleron's year-over-year bottom-line improvement as well. Without it, the company's net loss would have been much worse in Q2 since Acceleron's operating expenses increased significantly.

By far the most important news for Acceleron in the second quarter was its pipeline progress. The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for luspatercept in treating MDS-associated anemia and beta-thalassemia-associated anemia. The European Medicines Agency (EMA) also validated the Marketing Authorization Applications (MAAs) for luspatercept in these indications. 

Looking ahead

Acceleron Pharma CEO Habib Dable stated that the company is now "one step closer to the first-ever potential approval of an Acceleron-discovered medicine" thanks to the FDA and EMA review processes under way for luspatercept. He's right. And the outcomes of these regulatory decisions are the main things for investors to watch with Acceleron in the coming months.

The FDA should make its approval decision on luspatercept in the beta-thalassemia indication by Dec. 4, 2019. A decision on the drug in treating the MDS indication is expected by April 4, 2020. The EMA decision on approval for luspatercept in MDS- or beta-thalassemia-associated anemia is expected in the second half of next year.

In addition, Acceleron expects to report results from its phase 2 clinical study evaluating luspatercept in myelofibrosis later in 2019. The company also anticipates announcing top-line results from its Beyond phase 2 study of luspatercept in treating non-transfusion-dependent beta-thalassemia by the end of 2020.

Keith Speights owns shares of Celgene. The Motley Fool owns shares of and recommends Celgene. The Motley Fool has a disclosure policy.

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