Milestone Pharmaceuticals (MIST) Q4 2024 earnings summary

Executive summary

• Awaiting FDA decision on CARDAMYST nasal spray for PSVT, with a PDUFA date set for March 27, 2025; commercial launch targeted for mid-2025 upon approval.

• Well-capitalized to support commercialization, leveraging royalty financing.

• Initiated preparations for a Phase 3 trial of etripamil in AFib-RVR, expected to start in 2025.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled $69.7 million as of December 31, 2024, up from $66.0 million a year earlier.

• No revenue recorded in 2024, compared to $1.0 million in 2023 from a milestone payment.

• Research and development expenses decreased to $14.4 million in 2024 from $31.1 million in 2023, reflecting completion of Phase 3 studies.

• General and administrative expenses rose to $16.7 million in 2024 from $15.9 million in 2023, mainly due to higher outside service costs.

• Commercial expenses dropped to $11.0 million in 2024 from $15.1 million in 2023, following cost reductions after resolving an FDA Refusal to File letter.

• Net loss for 2024 was $41.5 million ($0.67 per share), improved from $59.7 million ($1.39 per share) in 2023.

Outlook and guidance

• CARDAMYST launch planned for mid-2025, pending FDA approval.

• Phase 3 trial for etripamil in AFib-RVR to commence in 2025, using a self-administration regimen.