Acceleron Pharma Inc (NASDAQ: XLRN) stock fell over 0.4% in the pre-market session on Feb 28th, 2020 (Source: Google finance) after the company posted mixed results for the fourth quarter of FY 19. XLRN in the fourth quarter of FY 19 has reported the adjusted loss per share of 44 cents, missing the analysts’ estimates for the adjusted loss per share of 32 cents, as per the Zacks Consensus Estimate. The company had reported the adjusted revenue of $39.34 million in the fourth quarter of FY 19.
XLRN intends to present the detailed topline results at the American Thoracic Society 2020 International Conference in May and to the upcoming interactions with health authorities as the company intends to globally develop and, if approved, commercialize sotatercept in PAH. The company also anticipates to announce topline results from the Phase 2 neuromuscular program in Charcot-Marie-Tooth disease in Marc. The company has generated cash, cash equivalents and investments as of December 31, 2019 of $453.8 million, which the company considers it to be sufficient to fund projected operating requirements until such time as it expects to receive significant royalty revenue from REBLOZYL sales. For FY 19, the company has reported the net loss of $124.9 million.
Meanwhile, in November, REBLOZYL (luspatercept-aamt) became the first and only FDA approved erythroid maturation agent and is now shows the indication of the treatment of anemia in adults with beta-thalassemia who require regular red blood cell transfusions. It is also a validation of Acceleron’s scientific platform leveraging the company’s expertise in the TGF-beta superfamily of proteins and the unwavering commitment for the development and commercialization of medicines to treat serious and rare diseases. Further, the Company and partner Bristol-Myers Squibb have announced their intensions for a pivotal Phase 3 study, called INDEPENDENCE, of luspatercept-aamt in adult patients with anemia associated with MF who are being treated with JAK inhibitor therapy and require RBC transfusions. The study is anticipated to open in 2020.
For FY 19, the company has reported the Collaboration revenue of $74 million. This revenue the company has received from the Company’s partnership with Bristol-Myers Squibb and is mainly related to expenses incurred by the Company in support of REBLOZYL, as well as one-time gross milestone payments totaling $60 million earned upon the FDA acceptance of the BLA and EMA validation of the MAA of REBLOZYL in June, and the FDA approval of REBLOZYL in November 2019.