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Jun 30, 2020
Agios Q2 2020 Earnings Report
Agios reported second quarter results, achieving key objectives across malignant hematology, solid tumors, and rare genetic diseases. Mitapivat clinical programs made significant progress, including proof-of-concept in sickle cell disease. A $255 million sale of IDHIFA® royalty extended cash runway through the end of 2022.
Key Takeaways
Agios Pharmaceuticals reported total revenue of $37.3 million for Q2 2020, which includes $27.6 million of net product revenue from sales of TIBSOVO®. Net loss was $90.5 million. The company's cash, cash equivalents, and marketable securities were $794 million as of June 30, 2020.
TIBSOVO® net sales of $27.6 million, an increase of 22% from the first quarter of 2020.
Completed a $255 million purchase agreement with Royalty Pharma for IDHIFA® (enasidenib) royalty rights and outstanding regulatory milestone payments.
Established clinical proof-of-concept for mitapivat in sickle cell disease.
Presented data on mitapivat in non-transfusion-dependent α- and ß-thalassemia.
Forward Guidance
Agios provided guidance for full-year 2020 U.S. revenue for TIBSOVO® of $105-115 million and expects cash, cash equivalents, and marketable securities will fund operations through the end of 2022.
Positive Outlook
- Deliver full-year 2020 U.S. revenue for TIBSOVO® of $105-115 million.
- Report data from ACTIVATE and ACTIVATE-T, the company’s two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency, between the end of 2020 and mid-2021.
- Finalize robust pivotal development plan for mitapivat in thalassemia, including both α-and ß-thalassemia, as well as transfusion dependent and non-transfusion dependent patient populations, by the end of 2020.
- Initiate first-in-human study in healthy volunteers for AG-946, a next-generation PKR activator, in Q3 2020.
- Receive European Medicines Agency CHMP opinion for TIBSOVO® in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by the end of 2020.
Challenges Ahead
- Risks and uncertainties related to the impact of the COVID-19 pandemic to Agios’ business, operations, strategy, goals and anticipated milestones.
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