Milestone Pharmaceuticals Inc. (MIST)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 delivered no revenue and a wider net loss as pre-launch spend resumed; diluted EPS of -$0.20 missed Wall Street consensus of -$0.18; revenue was in line at $0.0. Bold miss: EPS -$0.20 vs -$0.18 consensus; inline: revenue $0.0 vs $0.0 consensus *.
• FDA accepted MIST’s CRL response for CARDAMYST (etripamil) with a new PDUFA action date of December 13, 2025, and the RTW $75M royalty agreement approval deadline was extended to December 31, 2025—key regulatory and funding catalysts ahead of potential commercialization .
• Balance sheet strengthened via July offering: net proceeds of ~$48.7M; total gross proceeds up to $170M potential if Series A/B warrants are exercised, supporting launch readiness and working capital .
• Management maintains launch infrastructure and has restarted targeted pre-launch activities post-FDA acceptance, positioning for rapid commercialization if approved .

What Went Well and What Went Wrong

What Went Well

• FDA accepted the CRL response and set a new PDUFA date for CARDAMYST; CEO: “our team is energized as we work toward the potential approval of CARDAMYST in its first indication, PSVT” .
• Financing substantially improved liquidity (net proceeds ~$48.7M; up to $170M gross potential), and RTW royalty agreement tied to FDA approval extended through 2025, supporting commercial execution .
• AFib‑RVR Phase 3 protocol finalized with FDA concurrence; enrollment paused to prioritize PSVT launch preparation, indicating regulatory alignment and capital discipline .

What Went Wrong

• Pre-commercialization spend increased: commercial expense surged to $5.10M from $1.80M YoY, widening net loss to $13.0M from $9.4M YoY; EPS missed consensus by $0.02, reflecting higher operating costs ahead of launch *.
• Regulatory timeline shifted: PDUFA moved from March 27, 2025 to December 13, 2025 after the March CRL, delaying potential revenue ramp and pushing commercial timelines .
• Cash decreased to $43.4M at quarter-end vs $56.0M in Q1 and $69.7M at FY24 year-end prior to the July financing, underscoring burn through H1 and dependency on external capital until approval .

Financial Results

Income Statement Comparison

Notes: Amounts above are reported in thousands in company materials; table presents millions (rounded to two decimals) for losses and revenue.

Operating Expense Breakdown

Balance Sheet Highlights

Consensus vs. Actual

Values retrieved from S&P Global.*

Guidance Changes

No formal revenue, margin, OpEx, tax, or dividend guidance was issued for Q2 2025 .

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was available; analysis leverages the 8-K and press releases .

Management Commentary

• “With the FDA’s recent acceptance of our response to the CRL, our team is energized as we work toward the potential approval of CARDAMYST in its first indication, PSVT.” — Joe Oliveto, President & CEO .
• “We completed an equity financing in July which strengthened our balance sheet and extended our operating runway.” — Joe Oliveto .
• “Our recent Type A meeting with the FDA was productive… we appreciate the engagement with the FDA and are excited to prepare for a potential new PDUFA date this year.” — Joe Oliveto .
• “The FDA has not raised any concerns regarding the clinical section of the NDA.” — Company statement .

Q&A Highlights

No Q2 2025 conference call transcript was available; key clarifications from press releases:

• FDA clinical review: no concerns noted in the clinical section of the NDA; CRL centered on CMC items (nitrosamines and manufacturing testing facility inspection/transfer) .
• Pre-launch spend: OpEx ramp paused post-CRL, with targeted pre-launch activities restarted post-FDA acceptance, maintaining rapid-launch capability .

Estimates Context

• Q2 EPS missed consensus by $0.02 (actual -$0.20 vs -$0.18), driven by higher commercial and R&D spend ahead of potential launch; revenue in line at $0.0 as the company remains pre-commercial * *.
• Coverage is light (3 estimates), increasing potential for post-PDUFA revisions; launch timing shift likely defers revenue modeling to 2026 and raises focus on commercialization OpEx cadence*.

Values retrieved from S&P Global.*

Key Takeaways for Investors

• Regulatory de-risking: CRL response acceptance and firm PDUFA date re-anchor the path to approval; no clinical section concerns noted .
• Liquidity runway improved via July financing (net ~$48.7M; potential up to $170M gross with warrant exercises) and RTW royalty agreement extension to December 31, 2025, supporting launch readiness .
• Cost trajectory: commercial expense elevated ($5.10M in Q2) as targeted pre-launch activities resume; monitor OpEx discipline through H2’25 .
• Near-term catalysts: December 13, 2025 PDUFA and any interim regulatory updates; potential warrant exercises may further enhance liquidity .
• AFib-RVR optionality: Phase 3 protocol finalized with FDA; program paused near-term to prioritize PSVT launch—value lever post-PSVT approval .
• Trading lens: binary regulatory event into year-end; EPS likely to remain loss-making pre-approval; stock narrative tied to approval probability, commercialization readiness, and funding visibility .
• Post-approval execution: maintained infrastructure and pre-launch restart indicate readiness; payer engagement and KOL momentum from Q1 activities provide foundation for uptake if approved .

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