Executive Summary

Q4 2024 total revenue was $86.6M, driven by neffy net product revenue of $6.7M and collaboration revenue (ALK $73.5M; Japan $6.0M), with net income of $49.9M ($0.51 basic, $0.48 diluted); year-end cash, cash equivalents, and short-term investments were $314.0M .
FDA approved neffy 1 mg for children aged 4+ weighing 15–<30 kg on March 5, 2025; availability expected in May 2025, broadening the pediatric addressable market (~23% of prescriptions historically) and acting as a near-term adoption catalyst .
Payer coverage is accelerating: unrestricted commercial coverage expected to reach ~60% by end of Q1 2025 and ~80% by early Q3 2025; a national DTC campaign starts in May 2025 ahead of the summer peak prescribing season, designed to drive patient pull and prescriber confidence .
ALK licensing agreement brings $145M upfront; GAAP treatment recognized $73.5M as Q4 revenue with the remainder booked as liabilities due to repurchase option terms; additional ~$5M milestones are projected in Q2 and Q4 2025, with ~50% recognized as revenue, supporting at least a three-year operating runway .

What Went Well and What Went Wrong

What Went Well

Strong initial commercialization: neffy generated $7.3M FY2024 U.S. net product revenue since late September launch; Q4 net product revenue was $6.7M, supported by growing prescriber breadth and favorable payor decisions .
Meaningful clinical and market access momentum: FDA approval of neffy 1 mg for younger children, broadening reach; major PBMs/insurers added neffy, with unrestricted access accelerating through mid-2025 (“We remain on track for 80% unrestricted commercial coverage by the summer”) .
Balance sheet strength and disciplined growth plan: $314.0M at year-end positions ARS to step up commercialization (DTC $40–$50M in 2025) while maintaining ≥3-year runway; “well-equipped to further accelerate adoption and drive significant impact” .

What Went Wrong

Prior authorization burden constrained early adoption: physicians reported significant administrative friction; management expects a “tipping point” as unrestricted coverage ramps (Caremark/Anthem/Aetna expected on formulary by July 1) .
Elevated SG&A as commercialization ramped: SG&A rose to $35.5M in Q4 ($71.7M FY), reflecting sales force, marketing, and general operating expenses; R&D was modest ($3.0M Q4) as manufacturing supported launch .
GAAP accounting reduced recognized ALK revenue in Q4: $69.4M financing liability and $2.1M contract liability booked, limiting revenue recognition despite nonrefundable cash proceeds; future ALK cash milestones only partially recognized as revenue .

Financial Results

Consolidated performance (oldest → newest)

Metric	Q2 2024	Q3 2024	Q4 2024
Total Revenue ($USD Millions)	$0.5	$2.1	$86.6
Net Product Revenue – neffy ($USD Millions)	$0.0	$0.6	$6.7
Collaboration Revenue ($USD Millions)	$0.5	$1.5	$79.5 (ALK $73.5; Japan $6.0)
Supply Agreements Revenue ($USD Millions)	$0.0	$0.0	$0.4
Net Income (Loss) ($USD Millions)	$(12.5)	$(19.1)	$49.9
Diluted EPS ($USD)	$(0.18)	$(0.20)	$0.48
R&D Expense ($USD Millions)	$6.9	$4.4	$3.0
SG&A Expense ($USD Millions)	$8.9	$19.3	$35.5
Cash, Cash Equivalents & ST Investments ($USD Millions)	$218.7	$204.6	$314.0

Revenue breakdown detail

Segment	Q3 2024 ($USD Millions)	Q4 2024 ($USD Millions)
neffy Net Product Revenue (U.S.)	$0.568	$6.7
Collaboration – ALK	$0.0	$73.5
Collaboration – Japan (Alfresa)	$1.5	$6.0
Supply Agreements	$0.0	$0.4
Total	$2.068	$86.6

Full-year 2024 (context)

Metric	FY 2024
Total Revenue ($USD Millions)	$89.1
neffy Net Product Revenue ($USD Millions)	$7.3
Collaboration Revenue ($USD Millions)	$81.5
Supply Agreements ($USD Millions)	$0.4
Net Income ($USD Millions)	$8.0
Diluted EPS ($USD)	$0.08

Notes: ALK upfront cash was $145M, of which $73.5M recognized as Q4 collaboration revenue; $69.4M recorded as financing liability and $2.1M as contract liability due to GAAP treatment tied to repurchase options .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Operating Runway	≥3 years	Reiterated since Q2 2024 (“at least three years”)	Reiterated at FY-end 2024	Maintained
Payer Coverage (Unrestricted)	By end Q1 2025; early Q3 2025	“Coverage decisions expected by yearend” (not quantified)	~60% by end Q1 2025; ~80% by early Q3 2025	Raised specificity/targets
DTC Campaign	May–Summer 2025	None	Branded DTC starts May 2025; summer extension	New
DTC Spend	FY 2025	None	$40–$50M	New
neffy 1 mg Availability (U.S.)	May 2025	sNDA PDUFA Mar 6, 2025	Approved Mar 5, 2025; available May 2025	Achieved/Updated timing
ALK Milestones	Q2 & Q4 2025	Upfront disclosed; milestones anticipated	~$5M cash proceeds each in Q2 and Q4; ~50% recognized as GAAP revenue	Clarified recognition

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024)	Previous Mentions (Q3 2024)	Current Period (Q4 2024)	Trend
Payer Coverage / Prior Auth	Preparing for launch; discussions ongoing	Expect coverage decisions in Q4; targeting 60% in 6 months, 80% in 12 months	~51% unrestricted (as of Apr 1); Zinc/Caremark/Anthem/Aetna expected by July 1; 80% target by summer	Improving rapidly
Pediatric 1 mg Dose	sNDA planned; priority for pediatric reach	sNDA accepted; PDUFA 3/6/2025	Approved 3/5/2025; availability May 2025	Achieved/expanding pediatric
DTC Marketing	None	Considering acceleration post cash infusion	Branded DTC in May; $40–$50M spend	Initiating
Global Expansion	EMA positive opinion; EU approval expected Q3	EC approved EURneffy; ALK licensing signed	UK/Canada submissions; launches expected mid-2025 (Germany, UK if approved)	Scaling ex-U.S.
Clinical/RWD & Registry	Urticaria Phase 2b planned Q4 start	Phase 2b to start early 2025	Registry-based randomized study (600 pts; 400 neffy/200 IM) initiating Apr 2025; interim at next AAAAI	Advancing evidence
Commercial KPIs	Pre-launch readiness	5,700 HCPs reached; 1,700 BlinkRx scripts; 1,000+ allergists enrolled	~9,000 HCPs engaged; >4,000 BlinkRx prescribers; 2,500 allergists enrolled; broad payer wins	Scaling HCP engagement

Management Commentary

“Our strong execution throughout 2024 and into 2025 has positioned ARS Pharma for sustained growth... the successful U.S. launch of neffy, FDA approval of neffy 1 mg for younger children, and our expansion into new global markets mark key milestones” — Richard Lowenthal, CEO .
“We remain on track for 80% unrestricted commercial coverage by the summer of this year” — Richard Lowenthal, CEO .
“We are projecting a DTC campaign spend of between $40 million and $50 million in 2025… and still expect to maintain a runway of at least 3 years” — Kathleen Scott, CFO .

Q&A Highlights

Pediatric 1 mg ramp: Management views 1 mg as additive (~23% of prescriptions historically), especially among younger children and pediatric prescribers; product availability in May 2025 should materially benefit adoption .
Coverage trajectory and prior auth: ~51% unrestricted coverage as of April 1; Zinc agreement expected to bring Caremark/Anthem/Aetna onto formulary by July 1, pushing toward 80% unrestricted; prior auths are a major bottleneck, with doctors expecting to prescribe more as barriers fall .
Non-retail channels: Early interest from airline kit suppliers and institutional buyers; meaningful contributions likely over time once both 1 mg and 2 mg are broadly available .
Registry RCT design: Largest randomized controlled epinephrine study (600 patients), blinded to first dose; FDA focus on safety in “all comers”; interim analysis targeted for next AAAAI; full readout expected thereafter .
OTC epinephrine: Management does not expect OTC transition near-term due to safety/diagnosis hurdles; risk of overdose and self-diagnosis complexities cited .

Estimates Context

S&P Global Wall Street consensus for Q4 2024 revenue/EPS and the prior two quarters was unavailable at the time of query; therefore estimate comparisons could not be completed using S&P Global consensus (S&P Global data unavailable).
Company-referenced analyst consensus (as of Jan 10, 2025) for FY2024 net product sales was $4.1M; preliminary neffy net product sales came in at ~$7.1M, indicating a notable outperformance versus that benchmark cited by the company .

Key Operating and Market KPIs (Q4/FY Context)

KPI	Value
HCPs directly engaged by sales force	~9,000
HCPs submitting neffy scripts via BlinkRx (neffyConnect)	>4,000
% Prescriptions from highest-decile allergists	~81%
Allergists enrolled in neffy Experience Program	~2,500 (~15,000 doses available for clinic use)
Commercial access targets	>60% by end Q1 2025; >80% by early Q3 2025
Medicaid states (no prior auth)	Texas, Alabama, Montana (more expected through 2025)
neffyinSchools program	Two cartons of 2 mg per eligible K–12 school (1 mg to follow)

Key Takeaways for Investors

The Q4 print validates early neffy adoption with $6.7M quarterly net product revenue, while collaboration revenues (especially ALK) boosted total revenue and delivered profitability in the quarter .
Near-term catalysts: 1 mg U.S. availability in May, unrestricted coverage reaching ~80% by early Q3, and launch of a national DTC campaign designed to convert patient demand at scale .
Structural friction (prior auth) is the primary gating factor; coverage expansion should unlock materially higher script flow and multi-carton per patient purchasing behavior through retail channels .
Cash of $314M provides capacity to invest in demand-generation (DTC), sales-force reach, and evidence generation (registry RCT), while maintaining ≥3-year runway .
Ex-U.S. path is de-risking via ALK (EU/Canada/UK) and other partners (China/Japan/Australia), with launches expected mid-2025 in Germany/UK if approved .
Accounting nuances on ALK reduce GAAP revenue recognition for certain geographies (financing liability/contract liability), but do not affect nonrefundable cash proceeds; model revenue/EBITDA accordingly .
Watch adoption inflection through summer and back-to-school season, pediatric mix shift with 1 mg, and the coverage scorecard/public advocacy pressure that could accelerate payor adds .

ARS Pharmaceuticals, Inc. (SPRY)·Q4 2024 Earnings Summary