Acceleron Pharma, Inc. (NASDAQ:XLRN) Q3 2019 Earnings Conference Call Transcript

Nov 06, 2019 • 10:00 am ET

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Acceleron Pharma, Inc. (NASDAQ:XLRN) Q3 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good afternoon, ladies and gentlemen, and welcome to the Acceleron Third Quarter 2019 Earnings Conference Call. [Operator Instructions]

I would now like to hand the call over to Mr. Ed Joyce, Director of Investor Relations at Acceleron. Please go ahead.

Executive
Ed Joyce

Thanks, and welcome everyone to our Third Quarter 2019 Earnings Call. The press release reporting our financial results and clinical abstracts in addition to the presentation for today's webcast are available on the Investors & Media page of our corporate website at www.acceleronpharma.com.

Joining me for the call today are Habib Dable, our CEO; Kevin McLaughlin, our Chief Financial Officer; John Quisel, our Chief Business Officer; Sujay Kango, our Chief Commercial Officer; and Todd James, Vice President, Investor Relations and Corporate Communications.

As a reminder, we will be making forward-looking statements regarding our financial outlook in addition to regulatory, product development, commercialization plans and research activities. These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-K on file with the SEC.

I would like to now turn the call over to Habib Dable, our CEO.

Executive
Habib Dable

Great. Thank you Ed. Good morning everyone and thank you for joining us today. So, as you can see Acceleron, has deep expertise across the TGF-beta superfamily with significant development in the three disease areas. This is really an exciting time for us, with a number of near-term clinical and regulatory updates across our entire pipeline in the coming weeks and months. I am extremely proud of the tremendous progress of all of our disease area teams, beginning with luspatercept, the USFDA and the European Medicines Agency are currently reviewing the BLA and MAA filings respectively for the treatment of anemia in adult patients with beta-thalassemia who require regular red blood cell transfusions and for the treatment of anemia in adult patients with myelodysplastic syndromes who are RS negative -- who are RS position and RS positive and require red blood cell transfusions.

With FDA granting priority review for the beta-thalassemia indication, not far away from the potential of our first approval of an Acceleron discovered medicine with a PDUFA target action date of December 4, 2019. For the MDS indication, the FDA has set the target action date of April 4, 2020, our commercial organization has worked hard preparing for this milestone and I am pleased to report that will be ready upon FDA approval to begin making luspatercept available to patients.

In addition, regulators in the EU, are expected to deliver their decision on applications for both indications in the second half of 2020. We'll continue to work closely with both agencies to advance this therapy toward approval. We believe that luspatercept could bring significant benefit to benefit to patients with these blood disorders by potentially eliminating or decreasing the red blood cell transfusion burden. This is a huge achievement for Acceleron and our collaboration partner Celgene and another step forward