Fulcrum Therapeutics (FULC) Q2 2024 earnings summary

Executive summary

• Top-line data for the phase III REACH trial of losmapimod in FSHD is expected by the end of October 2024, with NDA and U.S. launch preparations underway.

• Entered a collaboration and license agreement with Sanofi for losmapimod outside the U.S., including an $80 million upfront payment and up to $975 million in potential milestones.

• Pociredir, an oral HbF inducer for sickle cell disease, is advancing in phase I-B trials, with data expected in 2025.

• Fulcrum expects to increase expenses and operating losses as it advances clinical and preclinical programs, requiring substantial additional funding.

• Discovery efforts continue for genetically defined rare diseases, including Diamond Blackfan Anemia under a license with CAMP4.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $273.8 million as of June 30, 2024, up from $236.2 million at year-end 2023, mainly due to the Sanofi upfront payment.

• Collaboration revenue was $80 million for Q2 2024, compared to $0.9 million in Q2 2023, reflecting the Sanofi payment.

• Net income for Q2 2024 was $55.4 million, versus a net loss of $23.8 million in Q2 2023; net income for the six months ended June 30, 2024 was $28.5 million.

• R&D expenses were $17.3 million for Q2 2024, slightly down year-over-year; G&A expenses were $10.2 million for Q2 2024, also down year-over-year.

• Net income per share, diluted, for Q2 2024: $0.87; weighted-average shares outstanding, diluted: 63.6 million.

Outlook and guidance

• Cash runway is expected to fund operations into 2027, supporting losmapimod development, commercialization, pociredir trials, and preclinical pipeline advancement.

• Excluding potential future milestone payments from Sanofi, a net loss is expected for the full year 2024 and foreseeable future.

• Anticipated appointment of Chief Commercial Officer in Q3 2024 to support U.S. launch.