Agios Pharmaceuticals Inc. (NASDAQ:AGIO) has announced its Q3 2020 financial results and provided business highlights.
Agios posted total revenue of $34.7 million in Q3
In Q3 2020, total revenue was $34.7 million, with TIBSOVO® net revenue being around $31. 7million. The company realized a $2.3 million collaboration revenue and royalty revenue of $0.7 million from IDHIFA® net sales under the collaboration agreement with Bristol Myers Squibb’s wholly-owned subsidiary, Celgene. Agios has narrowed its 2020 TIBSOVO® net revenue guidance in the US to between $113 million and $115 million. At the end of the quarter, the company had $722.4 million in cash and cash equivalents, which Agios believes will be adequate to fund operations through 2022.
Jackie Fouse, the company’s CEO, indicated that in Q3, Agios made considerable progress in executing against its 2020 key priorities and delivering medicines to patients needing them. Most importantly, the company delivered mature overall survival data from its Phase 3 ClarlDHy TIBSOVO® trial in patients who previously received cholangiocarcinoma treatment. Fouse added that Agios prepared for topline data readouts from its two Phase 3 global mitapivat studies in pyruvate kinase deficiency. Agios also advanced its vital plans for mitapivat in sickle cell disease and thalassemia. Fouse added that they are looking forward to building on these milestones with a catalyst-rich Q4 and 2021.
Agios withdrew MAA for TIBSOVO® In Europe
In Q3, the company submitted final data of the ClarlDHy Phase 3 TIBSOVO® overall survival results at the Virtual American Society of Clinical Oncology Gastrointestinal Cancers Symposium. During the quarter, Agios withdrew its TIBSOVO® Marketing Authorization Application in Europe in IDH1-mutant refractory or relapsed acute myeloid leukemia following feedback from EMA’s Committee for Medicinal Products for Human Use. The company also commenced Phase 1 AG-946 study in healthy volunteers. AG-946 is an oral, next-generation, small-molecule metabolic enzyme pyruvate Kinase-R activator.
By the end of this year, Agios expects to report ACTIVATE study topline results. ACTIVATE is a pivotal global study for mitapivat in pyruvate kinase deficiency adults that don’t get regular transfusions.