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AP

ARS Pharmaceuticals, Inc. (SPRY)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 topline accelerated: total revenue $32.5M, including $31.3M U.S. net product revenue from neffy; R&D $2.8M, SG&A $74.8M; net loss $(51.2)M or $(0.52) per share .
  • Management said neffy U.S. net product revenue of $31.3M “exceeded consensus expectations of $28.3M” (company-cited consensus); total Q4 sales expected to decline sequentially due to epinephrine seasonality and holiday timing; market share growth resumed into Q4 after late-Q3 pause from back‑to‑school scheduling dynamics .
  • Commercial KPIs strengthened: >18,000 HCPs have prescribed neffy (+86% vs Aug), aided consumer awareness rose to 56% by Sept; free virtual prescriber + $0 co‑pay launched in Nov to reduce prior‑auth/visit friction and support year‑round switches .
  • Liquidity/capital: $288.2M cash, cash equivalents and short‑term investments at 9/30/25; $100M term loan draw (SOFR + 5.5% interest‑only through Sept 2030) funds DTC and medical affairs; company believes cash funds operations through expected cash‑flow breakeven .

What Went Well and What Went Wrong

  • What Went Well
    • neffy U.S. net product revenue reached $31.3M (near 2.5x QoQ), with management stating it beat consensus; total revenue $32.5M .
    • Commercial reach expanding: >18,000 HCP prescribers (+86% vs Aug), ~6,500 schools in program; aided awareness 56% post‑DTC .
    • Real‑world evidence: 680 documented anaphylaxis cases with ~90% single‑dose effectiveness, “indistinguishable” from injection historically; supports prescriber confidence and promotional claims .
  • What Went Wrong
    • SG&A remained heavy at $74.8M given national DTC scaling, keeping operating losses elevated (loss from operations $(53.2)M) .
    • Late‑Q3 pause in market share growth linked to compressed HCP visit times during back‑to‑school; management expects seasonal Q4 sales downtick despite resumed share gains .
    • Prior authorization headwinds remain: overall ~50% of covered lives still require some PA; ~57% of U.S. commercial scripts do not require PA (i.e., 43% do) .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Total Revenue ($M)$2.07 $15.72 $32.50
Product Revenue, net ($M)$0.57 $12.80 $31.30
Collaboration/Milestone Rev. ($M)$1.50 $2.59 $0.06
Supply Rev. ($M)$0.00 $0.32 $1.15
Cost of Goods Sold ($M)$0.11 $4.98 $8.19
Gross Margin % (calc)94.6% 68.3% 74.8%
R&D ($M)$4.42 $4.04 $2.75
SG&A ($M)$19.28 $54.31 $74.75
Loss from Operations ($M)$(21.75) $(47.61) $(53.19)
Net Loss ($M)$(19.13) $(44.88) $(51.15)
Diluted EPS ($)$(0.20) $(0.46) $(0.52)

Notes: Gross Margin % = (Total Revenue − COGS) / Total Revenue; calculated from reported figures with citations to source values.

Liquidity

  • Cash, cash equivalents & short‑term investments: $275.7M (Q1’25), $240.1M (Q2’25), $288.2M (Q3’25) .
  • Term loan: $100M drawn in Sept; SOFR + 5.5%; interest‑only through Sept 2030 .

KPIs and Commercial Metrics

KPIQ1 2025Q2 2025Q3 2025
HCPs who have prescribed neffy>5,000 9,700 >18,000 (+86% vs Aug)
Schools in neffy-in-Schools~1,000 >3,200 >6,500
Consumer aided awareness of neffy~20% baseline pre‑DTC 49% (late July) 56% (Sept)
Gross-to-net retentionProgressing toward ~50% steady‑state (CFO) 52% in Q2 Low‑mid 50% expected going forward
PA burden snapshot–57% commercial w/o PA ~50% overall still require some PA; 57% commercial w/o PA

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Gross-to-net retentionSteady-state~50% steady-state expected Low–mid 50% going forward Maintained/refined
FY2025 cash-based operating expensesFY2025Not previously specified$210–$220M Introduced
Cash runwayMulti‑yearOper. plans ≥3 years (Q1/Q2) Fund ops through expected cash‑flow breakeven Reframed (toward breakeven)
Q4 revenue outlookQ4 2025–Q4 sales to decline vs Q3 on seasonality/holidays; share growth resumed New color
GTN retention thresholdLong‑termAt least 50% retention guidance At least 50% retained including $0 co‑pay Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
DTC/awarenessQ1: DTC launch mid‑May . Q2: awareness 49% by late July; ~$50M FY25 DTC spend .Awareness 56% by Sept; Get neffy on Us integrated into DTC; new TV spots highlighting virtual prescriber .Strengthening reach, messaging refinement.
Access/prior authQ1: 57% commercial coverage secured, momentum to 80%+ early Q3 . Q2: 93% commercial coverage; 57% no PA; 80%+ PA approvals for some Zinc plans .~50% overall still require PA; 57% of commercial scripts w/o PA; payer work ongoing (Caremark, Prime, Anthem) .Improving but mixed; big PBM decisions still catalysts.
Seasonality & IQVIA opticsQ2: Anticipated back‑to‑school lift .Late‑Q3 share pause due to HCP time constraints; IQVIA undercaptures certain channels; Q4 seasonal decline expected .Manage to through-cycle with virtual prescriber.
Real‑world evidenceQ2: 20k doses placed for in‑office rescue; outcomes to be shared .680 cases; ~90% single‑dose effective; indistinguishable from injections; ACAAI oral late‑breaker; publication slated Nov 24 .Evidence base maturing; strong promotional lever.
Virtual prescriber/$0 co‑pay–Program launched Nov 2025 to bypass office burden and PAs; expected to smooth seasonality .New structural growth lever in place.
InternationalQ2: UK approval, Germany launch; Canada/Japan/Aus pending .Japan approval; UK launch; Canada/China approvals expected 1H26; royalties booked to financing liability .Building ex‑U.S. footprint via partners.
CapitalQ1/Q2: Cash $275.7M/$240.1M .$100M term loan (SOFR+5.5%), cash to breakeven .Enhanced flexibility without equity dilution.

Management Commentary

  • “We are executing our commercial strategy across multiple fronts… direct‑to‑consumer campaigns are generating measurable increases in patient awareness; real‑world evidence data are further strengthening prescriber confidence… free virtual prescriber option and zero dollar co‑pay to further reduce barriers” — Richard Lowenthal, CEO .
  • “U.S. net product revenue for neffy grew again quarter over quarter, reaching $31.3 million… a 2.5‑fold increase from the prior quarter and exceeding consensus expectations of $28.3 million” .
  • “Looking ahead to Q4, market share growth has resumed, although we anticipate Q4 sales will decrease from Q3 given the overall epinephrine market typically declines about one‑third due to seasonality and the holidays” .
  • “Our current cash position is expected to be sufficient to achieve cash flow breakeven without additional equity financing… $100 million term loan… SOFR plus 5.5%, with interest‑only payments through September 2030” — CFO Kathleen Scott .

Q&A Highlights

  • Consensus/expectations: Management characterized Q3 performance as meeting internal expectations and beating analyst expectations on neffy U.S. net product revenue; emphasized learnings from HCP “doctor burden” during summer .
  • Access/PAs: About 50% of covered lives still require PA; within commercial, ~57% of scripts do not require PA; Payer discussions ongoing (Caremark, Prime, Anthem) with optimism for improved status in 1H26 .
  • IQVIA/Channels/Inventory: IQVIA undercaptures institutional/clinic/wholesale channels; retail vs other channels ~55/45; distributors target 15–20 days inventory and will destock into Q4 seasonality .
  • International: UK physicians/patients enthusiastic; adoption likely to resemble Germany given seamless reimbursement .
  • Virtual prescriber impact: Positive physician feedback; reduces time burden and PA friction; integrated across DTC; expected to support year‑round switching and reduce drop‑off .

Estimates Context

  • S&P Global (Capital IQ) consensus estimates for Q3 2025 were unavailable via our estimates tool at this time (no data returned).
  • Management stated that neffy U.S. net product revenue of $31.3M “exceeded consensus expectations of $28.3M” (company‑cited consensus figure) .
  • Implication: Given the apparent top‑line beat on the company’s cited revenue benchmark, Street models may need to recalibrate GTN retention durability, DTC elasticity, and seasonality impacts in Q4 and 2026 trajectory .

Key Takeaways for Investors

  • neffy demand momentum is real: U.S. net product revenue of $31.3M rose ~2.5x QoQ; commercial KPIs (HCPs, schools, awareness) point to sustainable adoption drivers .
  • Mix/GTN improving: CFO indicates low–mid 50% GTN retention going forward, with cash scripts falling and point‑of‑sale copay optimization aiding predictability .
  • Seasonality is a near‑term headwind: Management expects Q4 sales to decline sequentially; use any print‑related weakness to assess 2026 growth levers (virtual prescriber, broader coverage, ex‑U.S. royalties) .
  • Structural access catalysts: Further PBM wins (Caremark/Prime) and PA reduction remain upside drivers; management is actively engaged and optimistic on 1H26 timing .
  • Validation via real‑world evidence: ~90% single‑dose effectiveness in 680 cases, with outcomes “indistinguishable” from injections, should continue to support prescriber conversion and refill behavior .
  • Balance sheet extends runway: $288.2M liquidity and a non‑dilutive $100M loan provide capacity to sustain DTC and evidence generation through expected cash‑flow breakeven .
  • International optionality: UK launch, Japan approval, and expected Canada/China approvals in 1H26 build ex‑U.S. contribution potential and signal global demand .

Appendix: Additional Data

Selected Operating Highlights (Q3 2025)

  • U.S. net product revenue: $31.3M; supply revenue: $1.15M; total revenue: $32.5M .
  • R&D $2.75M (Phase 2b urticaria, registry); SG&A $74.75M (DTC + commercialization); net loss $(51.15)M; EPS $(0.52) .
  • Cash, cash equivalents & STI: $288.2M as of 9/30/25; shares outstanding 98.84M .
  • Real‑world evidence: ~90% single‑dose effectiveness in 680 anaphylaxis cases; ACAAI oral late‑breaker in Nov; publication slated Nov 24 .

Citations:

  • Q3 2025 8‑K and Exhibit 99.1 press release including financial tables: .
  • Q3 2025 earnings call transcript: .
  • Q2 2025 8‑K and press release/tables: .
  • Q2 2025 transcript: .
  • Q1 2025 8‑K and press release/tables: .