ARS Pharmaceuticals, Inc. (SPRY)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue was $8.0M, comprised of $7.8M U.S. net product revenue for neffy and $0.2M collaboration revenue; net loss was $(33.9)M or $(0.35) per share as SG&A ramped with commercialization and DTC prep .
• Commercial access reached 57% of U.S. commercial lives with no prior authorization, with management reiterating a goal of 80%+ by early Q3 2025; pediatric 1 mg dose is now available nationwide, expanding the addressable pediatric segment .
• 2025 operating expense guidance was raised to $210–$220M (ex-SBC and COGS), reflecting DTC spend ($40–$50M) and ALK co-promotion investment; cash, equivalents, and short-term investments were $275.7M, supporting a ≥3-year runway .
• Call catalysts: national DTC campaign launch (May 15), ALK co-promotion expanding promotional reach to ~20,000 HCPs including ~9,000 pediatricians, and payer wins (e.g., UnitedHealthcare) positioning for a Q3 inflection in prescriptions .

What Went Well and What Went Wrong

What Went Well

• Strong early commercial traction: neffy generated $7.8M in U.S. net product revenue despite prior-auth headwinds; >5,000 physicians have prescribed to date, and the sales force has engaged >10,000 priority HCPs .
• Access and pediatric expansion: 57% commercial coverage without prior auth and nationwide availability of 1 mg dose for children 15–30 kg—management expects this pediatric dose to materially contribute during peak summer/back-to-school season .
• Management conviction and positioning: “We’ve built strong momentum for neffy’s U.S. launch and are well positioned heading into the peak epinephrine prescribing season this summer,” CEO Richard Lowenthal said, highlighting payer wins and expanded reach via ALK .

What Went Wrong

• Elevated SG&A to build brand and access: SG&A was $41.1M in Q1 as the company invested in commercialization and prepared DTC, driving a $(33.9)M net loss in the seasonally lower quarter .
• Prior authorization remains a headwind: Though improving, ~45% of prescriptions required PAs early in the year; management cited the administrative burden and is pushing toward unrestricted coverage to reduce friction .
• Gross-to-net still above steady-state: Q1 gross-to-net hovered “a little over 60%,” with management targeting ~50% over time as coverage improves; COGS will rise modestly as expensed pre-approval inventory is consumed over ~18 months .

Financial Results

Sequential trend (oldest → newest)

Year-over-year comparison (Q1 2025 vs Q1 2024)

Balance sheet snapshot

KPIs and Commercial Progress

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We’ve built strong momentum for neffy’s U.S. launch and are well positioned heading into the peak epinephrine prescribing season this summer.” — Richard Lowenthal, CEO .
• “Currently, over 57% of all U.S. commercial lives have access to neffy… We are approaching a tipping point in market access that will enable more health care providers to prescribe neffy without restrictions.” — Eric Karas, CCO .
• “We project total 2025 operating expenses of between $210 million and $220 million… We believe this is a solid investment in our future growth potential in the pediatric market.” — Kathleen Scott, CFO .

Q&A Highlights

• Access dynamics: 57% coverage without prior auth; ~90% including PAs with 60–80% approval rates; reducing PA burden is key to accelerating adoption .
• Gross-to-net trajectory: Q1 gross-to-net a little over 60%; management expects trend toward ~50% as coverage improves and cash sales decline .
• neffyExperience outcomes: ~90% single-dose response, ~10% second dose—consistent with injections; plans to publish and present data to support broader adoption .
• Seasonal inflection: Management expects a Q3 inflection (Aug–Sep peak), aided by pediatric 1 mg availability, DTC awareness, and expanding unrestricted coverage .
• Market share: ~1.3% category share overall; ~6.2% among directly targeted prescribers; ALK co-promotion expected to expand reach and share .

Estimates Context

• S&P Global consensus for Q1 2025 EPS and revenue was unavailable at the time of retrieval; therefore, beats/misses versus consensus cannot be assessed here.*
• Company-cited analyst estimate context: management’s January presentation noted FY 2024 analyst consensus net product sales of ~$4.1M vs actual $7.3M reported, indicating an early outperformance versus expectations .

*Values retrieved from S&P Global

Key Takeaways for Investors

• Early commercialization is tracking: sequential product revenue growth ($6.7M → $7.8M) alongside rising SG&A reflects disciplined investment ahead of peak seasonal demand and DTC activation .
• Coverage momentum is a pivotal near-term driver: unrestricted access at 57% today, with management targeting 80%+ by early Q3; each incremental payer decision reduces PA friction and should accelerate prescriptions .
• Pediatric expansion matters: nationwide 1 mg availability addresses ~23% of epinephrine units and a large pediatric need, poised to amplify Q3 seasonality .
• DTC and co-promotion are force multipliers: multi-channel campaign and ALK’s pediatric reach (~9,000 pediatricians) should improve patient pull and prescriber push into Q3 .
• Financial runway is solid: $275.7M in liquidity supports elevated 2025 OpEx and strategic initiatives while maintaining a ≥3-year runway .
• Watch gross-to-net normalization and COGS: GTN trending toward ~50% and modest COGS step-up as expensed inventory is utilized over ~18 months—both predictable levers in model calibration .
• Trading implication: Near-term setup favors a Q3 narrative shift as DTC, pediatric dose availability, and broadened coverage converge; monitor payer adds (e.g., Caremark/Aetna timelines) and weekly script momentum .