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10-K2026-03-20· x-ai/grok-4.1-fast

MIST · Milestone Pharmaceuticals Inc.

0001104659-26-032415

SEC filing

Summary

Milestone Pharmaceuticals Inc. (MIST) reported FY 2025 results with revenue of $1.5M from a license milestone under the Corxel agreement following FDA approval of CARDAMYST (etripamil) nasal spray for PSVT on December 12, 2025. This marked the first revenue since inception, up from $0 in 2024. Operating expenses surged 51.3% YoY to $63.7M, driven by commercial expenses doubling to $28.3M for launch preparations, R&D at $18.1M (up 26.1%), and G&A at $17.3M (up 3.2%). Loss from operations widened to -$62.1M from -$42.1M. Net loss increased 51.9% YoY to -$63.1M, or -$0.75 per share (vs. -$0.67 prior year), after $2.9M interest income offset by $3.8M expense. Balance sheet strengthened with $73.0M cash equivalents and $32.9M short-term investments (total liquidity ~$105.9M), total assets $113.6M, equity $41.8M. Cash used in operations was -$49.0M, offset by $85.5M financing inflows, netting $47.7M cash increase. Focus remains on CARDAMYST commercialization, AFib-RVR Phase 3, and partnerships, with sufficient runway for 12+ months.

Key takeaways

Full analysis

Performance Summary

Milestone Pharmaceuticals reported FY 2025 net loss of -$63.1M, up 51.9% YoY from -$41.5M in 2024, driven by first revenue of $1.5M from Corxel milestone post-FDA approval of CARDAMYST on Dec 12, 2025. Loss from operations expanded to -$62.1M (YoY -47.6%) amid commercial ramp-up ($28.3M, +157.2%), R&D $18.1M (+26.1%), G&A $17.3M (+3.2%). EPS diluted -$0.75 vs. -$0.67. Balance sheet robust: cash $73.0M, short-term investments $32.9M, total assets $113.6M (up from $75.5M), equity $41.8M. Cash flow: ops -$49.0M (+70% use), investing +$11.2M, financing +$85.5M from offerings/warrants, net cash +$47.7M.

Revenue Analysis

Revenue $1.5M solely from Ji Xing License Agreement milestone upon FDA PSVT approval; $0 in 2024. No product sales yet; CARDAMYST launched Q1 2026. Single segment biopharma operations. License receivable $1.5M on balance sheet. Future royalties/milestones from Corxel (China) and potential EU/others.

Margins & Profitability

No gross profit as pre-commercial. Operating margin N/A (loss -$62.1M on $1.5M revenue). Expenses dominated by commercial 44% of opex, reflecting launch investments. Share-based comp $7.5M. Interest expense $3.8M on $57.2M convertible notes; income $2.9M on investments.

Cash Flow & Balance Sheet

Ops cash -$49.0M (non-cash adj: $7.5M SBC, $3.8M interest/debt). Investing +$11.2M (net investments +$11.6M redemptions, -$0.3M capex). Financing +$85.5M (offerings $37.6M common/$2.6M pre-funded/$22.9M warrants, $21.7M exercises). Liquidity $105.9M supports 12+ months runway. Debt $57.2M senior notes; liab $71.8M. Inventory $0.6M post-approval.

Outlook

Priorities: CARDAMYST US commercialization (60 reps targeting 500K patients), etripamil AFib-RVR Phase 3 (sNDA path), ex-US approvals (EMA MAA Nov 2025, China NDA accepted). $75M royalty sale closed Jan 2026. Expect rising commercial/R&D spend; sufficient cash for operations.