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Dec 31, 2020
Blueprint Medicines Q4 2020 Earnings Report
Blueprint Medicines' Q4 2020 financial results were reported, featuring revenue from AYVAKIT and GAVRETO, along with progress in clinical and research programs.
Key Takeaways
Blueprint Medicines reported Q4 2020 financial results, including $6.0 million in net product revenues from AYVAKIT and $0.7 million from GAVRETO. The FDA accepted the supplemental NDA for AYVAKIT for advanced systemic mastocytosis, granting priority review with an action date of June 16, 2021.
AYVAKIT/AYVAKYT recorded $6.0 million in net product revenue.
GAVRETO recorded $0.7 million in net product revenue.
FDA accepted supplemental NDA for AYVAKIT for advanced systemic mastocytosis with priority review.
A Type II variation MAA was submitted to the EMA for AYVAKYT for advanced systemic mastocytosis.
Forward Guidance
Blueprint Medicines plans to achieve several milestones by mid-2021, including providing portfolio updates at the AACR 2021 Annual Meeting, obtaining regulatory approval from the European Commission and launching GAVRETO in Europe, initiating a Phase 1 trial of BLU-945, obtaining FDA approval and launching AYVAKIT in advanced SM in the U.S., completing enrollment of the registration-enabling Part 2 of the PIONEER trial of AYVAKIT, and initiating the Phase 2 HARBOR trial of BLU-263.
Positive Outlook
- Provide portfolio updates across clinical and research programs at the AACR 2021 Annual Meeting.
- Obtain regulatory approval from the European Commission and launch GAVRETO in RET fusion-positive NSCLC in Europe in the first half of 2021.
- Initiate a Phase 1 trial of BLU-945, a triple-mutant EGFR inhibitor, in patients with treatment-resistant EGFR-driven NSCLC in the first half of 2021.
- Obtain FDA approval and launch AYVAKIT in advanced SM in the U.S. in the first half of 2021.
- Complete enrollment of the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced SM in mid-2021.
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