SpringWorks Therapeutics (SWTX) Q3 2024 earnings summary

Executive summary

• OGSIVEO net product revenue reached $49.3 million in Q3 2024, a 23% increase over Q2, with year-to-date revenue of $110.5 million and strong adoption among desmoid tumor patients.

• Mirdametinib NDA for NF1-PN is under FDA Priority Review (PDUFA date: February 28, 2025) and EMA validation, with commercial preparations underway for U.S. and EU launches.

• Net loss narrowed to $53.5 million ($0.72 per share) in Q3 2024 from $79.4 million ($1.27 per share) in Q3 2023.

• Cash, cash equivalents, and marketable securities totaled $498.1 million as of September 30, 2024, expected to fund operations through anticipated profitability in H1 2026.

• The addressable desmoid tumor patient population is now estimated to be significantly larger than previously thought, with over 10,000 unique patients identified via ICD-10 codes in under a year.

Financial highlights

• Q3 2024 OGSIVEO net product revenue was $49.3 million, with nine-month revenue at $110.5 million.

• Net loss for Q3 2024 was $53.5 million, improved from $79.4 million in Q3 2023.

• Operating expenses increased year-over-year due to commercial activities for OGSIVEO and anticipated mirdametinib launch, with SG&A at $61.6 million and R&D at $42.3 million in Q3 2024.

• Gross margin for Q3 2024 was $45.96 million, with cost of product revenue at $3.3 million.

• Cash, cash equivalents, and marketable securities totaled $498.1 million at quarter end.

Outlook and guidance

• Profitability is targeted for the first half of 2026, with current cash expected to fund operations until then.

• Anticipated EU approval and launch of OGSIVEO in the first half of 2025, starting with Germany and France.

• Full transition to OGSIVEO blister packaging expected by year-end 2024, improving refill rates and compliance.

• Initial data from the Phase 2 trial of nirogacestat in ovarian granulosa cell tumors expected in H1 2025.

• Additional data from ongoing clinical trials to be presented at upcoming medical conferences.