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Mar 31, 2020
Agios Q1 2020 Earnings Report
Agios reported first quarter results, highlighting TIBSOVO® net revenue of $22.7 million and reiterated 2020 TIBSOVO® net U.S. revenue guidance.
Key Takeaways
Agios Pharmaceuticals reported a total revenue of $87.1 million for the first quarter of 2020, which includes $22.7 million from TIBSOVO® net product revenue. The company's net loss was $40.3 million. They anticipate funding operating expenses through June 2022 due to cash conservation actions.
TIBSOVO® net sales increased by 16% and total number of unique prescribers expanded by 25% from the fourth quarter of 2019.
Enrollment was completed in ACTIVATE, the ongoing pivotal trial of mitapivat in adults with pyruvate kinase (PK) deficiency.
Agios continues to expect its 2020 TIBSOVO® net U.S. revenue to be between $105 and 115 million.
Cash conservation efforts extend runway to the end of June 2022.
Forward Guidance
Agios continues to expect its 2020 TIBSOVO® net U.S. revenue to be between $105 and 115 million.
Positive Outlook
- The EU regulatory process for TIBSOVO® in relapsed and refractory AML remains on track with a CHMP opinion expected by the end of 2020.
- Agios remains on track to name a new development candidate by the end of the year.
- The decision on proof-of-concept for mitapivat in sickle cell disease remains on track for mid-2020.
- ACTIVATE and ACTIVATE-T topline data are now expected between the end of 2020 and mid-2021.
- Agios still expects mature overall survival data from the ClarIDHy study in mid-2020.
Challenges Ahead
- Agios expects some delays in its clinical programs based on anticipated challenges related to data collection, access to trial sites and patient enrollment due to hospitals globally shifting resources to treat patients with COVID-19.
- Enrollment completion for AGILE, Myelodysplastic Syndrome (MDS) is now expected in 2021 versus previous guidance of the end of 2020.
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