Executive Summary

Q3 2025 delivered a narrower loss and an EPS beat versus consensus, supported by moderated operating expenses and interest income; EPS was -$0.12 vs consensus -$0.17, a $0.05 beat, with revenue at $0 as the company remains pre-commercial *. Values retrieved from S&P Global.
Commercial launch readiness advanced ahead of the December 13, 2025 PDUFA date for CARDAMYST (etripamil) in PSVT; management emphasized quick-start capability and strengthened balance sheet, including an expected $75M royalty payment upon approval .
Cash, cash equivalents and short-term investments ended Q3 at $82.6M, up from $43.4M at Q2 and $56.0M at Q1, reflecting July equity financing and positioning for launch .
AFib-RVR second indication progressed with Phase 3 protocol finalized (ReVeRA-301); enrollment initiation remains paused to prioritize PSVT launch readiness; additional supportive clinical and guideline references presented at AHA Scientific Sessions .

What Went Well and What Went Wrong

What Went Well

Management highlighted launch readiness and resources to execute quickly upon potential FDA approval, underscoring confidence: “We strengthened our balance sheet… together with the $75 million royalty payment upon FDA approval, we believe we have resources in place to drive a successful commercial launch.” .
EPS beat vs consensus (-$0.12 actual vs -$0.17 estimate), driven by moderated operating expenses and interest income, despite ongoing commercialization investments *. Values retrieved from S&P Global.
Clinical narrative strengthened: new analyses across >600 patients showed aligned efficacy/safety and AHA ACLS Guidelines referenced intranasal calcium channel blockers, supporting etripamil’s value proposition .

What Went Wrong

Pre-revenue status persisted; no Q3 revenue, reflecting timing ahead of potential approval and launch, keeping financials dependent on external financing and royalty arrangements .
Net loss increased year over year to $11.9M vs $9.4M in Q3 2024, driven by higher commercial spend for launch preparation despite some G&A moderation .
No formal financial guidance ranges were provided (revenue, margins, OpEx), limiting visibility for near-term modeling ahead of the binary PDUFA event .

Financial Results

Income Statement and EPS (Quarterly)

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Revenue ($USD Millions)	$0.0	$0.0	$0.0	$0.0
Net Loss ($USD Millions)	$9.4	$20.8	$13.0	$11.9
EPS ($USD)	-$0.14	-$0.31	-$0.20	-$0.12
R&D Expense ($USD Millions)	$4.0	$5.0	$3.7	$3.9
G&A Expense ($USD Millions)	$3.7	$5.2	$3.8	$3.3
Commercial Expense ($USD Millions)	$1.9	$10.4	$5.1	$4.6

Notes: YoY growth in commercial expense reflects pre-launch investments; QoQ moderation from Q1→Q3 indicates pacing around CRL resolution and prioritized PSVT launch readiness .

Balance Sheet KPIs (Quarter-end)

Metric	Q1 2025	Q2 2025	Q3 2025
Cash + Short-term Investments ($USD Millions)	$56.0	$43.4 (pre-offering; net +$48.7M raised in July)	$82.6
Senior Secured Convertible Notes ($USD Millions)	$54.3	$55.2	$56.2
Total Shareholders’ Equity ($USD Millions)	-$6.1	-$17.7	$20.5
Weighted Avg Shares (Basic & Diluted)	66.3M	66.4M	96.5M

Estimates vs Actuals (Q3 2025)

Metric	Consensus (S&P Global)	Actual	Surprise
EPS ($USD)	-$0.17*	-$0.12	+$0.05; Bold beat
Revenue ($USD Millions)	$0.0*	$0.0	In line

Values retrieved from S&P Global.

Segment breakdown: Not applicable (pre-commercial; no reported revenue segments) .

Margins: Not meaningful given zero revenue (Gross/EBIT/Net Income margin %) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
CARDAMYST PSVT PDUFA	December 13, 2025	PDUFA reset in July to 12/13/25	PDUFA remains 12/13/25; launch readiness emphasized	Maintained timeline
Royalty Purchase Agreement (RPA)	Post-approval 2025	Extended approval deadline to 12/31/25	$75M payment upon FDA approval reiterated	Maintained terms
Commercial Launch Plan	Near-term post-approval	Maintained capability; pre-launch paused during CRL	Quick-start capability; ramping OpEx for launch readiness	Raised activity
AFib-RVR (ReVeRA-301)	2025+	Phase 3 protocol finalized; enrollment paused	Protocol finalized; plan to leverage PSVT NDA; enrollment still paused to focus PSVT	Maintained priority sequencing

No formal quantitative guidance (revenue, margins, OpEx ranges, tax) provided .

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was located after searching company filings and investor site; Q&A detail unavailable [ListDocuments: earnings-call-transcript=0] .

Topic	Previous Mentions (Q1 2025, Q2 2025)	Current Period (Q3 2025)	Trend
Regulatory/CRL Resolution	CRL received; CMC issues; Plan Type A meeting	NDA under review; PDUFA 12/13/25	Positive progression
Commercialization Readiness	Paused ramp; maintained capability	Quick-start launch plans; ramping OpEx for readiness	Accelerating
Financing/Runway	$56.0M cash+STI; negative equity	July offering net ~$48.7M; $82.6M cash+STI; positive equity	Strengthened
Product Performance Narrative	ACC.25 poster; supportive NODE-303 data	New analyses across >600 pts; AHA ACLS reference to intranasal CCBs	Reinforced
Second Indication (AFib-RVR)	Phase 3 protocol finalized; enrollment paused	Protocol finalized; sNDA path; leverage PSVT NDA + AFib-RVR Phase 3	Maintained; clarity

Management Commentary

“We are approaching our December 13 PDUFA date with optimism and excitement… we believe we have resources in place to drive a successful commercial launch.” — Joseph Oliveto, President & CEO .
“New analysis… showed aligned efficacy and safety… with etripamil achieving consistently greater conversion rates for symptomatic PSVT episodes compared with placebo arms.” .
“With the resolution of the Complete Response Letter (CRL) we are now ramping operational expenditures in order to launch quickly following the potential approval of CARDAMYST by the FDA.” .

Q&A Highlights

No Q3 2025 earnings call transcript was available across SEC filings and the company investor site; as such, Q&A themes, clarifications, and tone changes cannot be assessed for Q3 [ListDocuments: earnings-call-transcript=0] .

Estimates Context

EPS beat: -$0.12 actual vs -$0.17 consensus; magnitude of beat $0.05. Drivers include moderated OpEx (G&A down YoY; commercial spend paced QoQ) and interest income *. Values retrieved from S&P Global.
Revenue in line at $0; pre-commercial status consistent with expectations *. Values retrieved from S&P Global.
EPS estimates were based on 3 contributing estimates; revenue estimates from 4 contributors for Q3 2025*. Values retrieved from S&P Global.

Key Takeaways for Investors

The December 13, 2025 PDUFA represents the near-term binary catalyst; management is prepared for a rapid launch upon approval, with $75M RPA funds anticipated post-approval .
EPS beat and improved loss trajectory suggest disciplined OpEx pacing heading into launch; however, YoY net loss still increased due to commercialization investments .
Cash and short-term investments of $82.6M and July financing bolster runway to support launch; equity turning positive reflects balance sheet reinforcement ahead of commercialization .
Clinical and guideline momentum (AHA ACLS references; analyses across >600 patients) enhance product narrative and potential payer/provider receptivity upon launch .
Second indication optionality in AFib-RVR (protocol finalized; sNDA pathway) could expand TAM, albeit sequencing indicates PSVT launch takes precedence .
Trading implications: event-driven setup into PDUFA; position sizing should reflect binary FDA outcome risk; post-approval focus shifts to launch execution pace, payer access, and patient adoption curves .
Near-term modeling remains constrained without formal guidance; monitor OpEx cadence, working capital needs, and any early launch metrics disclosed in subsequent updates .

Additional Q3-relevant press releases: Inducement grants (Nov 4) and AHA analyses (Nov 3) provide incremental context around hiring and clinical positioning .

Milestone Pharmaceuticals Inc. (MIST)·Q3 2025 Earnings Summary