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Mar 31, 2024
SpringWorks Therapeutics Q1 2024 Earnings Report
Reported first quarter financial results and highlighted recent business updates.
Key Takeaways
SpringWorks Therapeutics reported a strong start to the OGSIVEO launch with $21.0 million in net product revenue for the first quarter of 2024. They also initiated the rolling NDA submission for mirdametinib in children and adults with NF1-PN.
Achieved $21.0 million in OGSIVEO net product revenue in Q1 2024.
Received validation from the EMA for MAA of nirogacestat for the treatment of adults with desmoid tumors.
Initiated rolling submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN.
Phase 2b ReNeu trial results accepted for oral presentation at the 2024 ASCO Annual Meeting.
Revenue by Segment
Forward Guidance
The company is focused on continuing momentum towards establishing OGSIVEO as the standard of care treatment for adults with desmoid tumors and progressing mirdametinib for NF1-PN. They anticipate several data presentations and regulatory submissions throughout the year.
Positive Outlook
- On track to report initial data from the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors in the second half of 2024.
- SpringWorks expects to complete the NDA submission in the second quarter of 2024 and expects to file a MAA with the EMA for mirdametinib for the treatment of children and adults with NF1-PN in the European Union the second half of 2024.
- On track to present additional data from the dose expansion portion of the Phase 1b trial evaluating brimarafenib (BGB-3245) in adult patients with RAF mutant solid tumors in the second half of 2024.
- On track to initiate a Phase 1a trial of SW-682, an investigational novel, oral, potent, and selective pan-TEAD inhibitor, in Hippo-mutant solid tumors in the second quarter of 2024.
- The blister packs are expected to be on the market in mid-May 2024.
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