Executive Summary

Q3 2025: Revenue $12.807M and diluted EPS $(0.14); non-GAAP adjusted EBITDA loss $(8.563) as SG&A rose with pre-launch spending for Anaphylm; GAAP gross margin 65%, slightly lower than Q3 2024 .
FDA confirmed no Advisory Committee and is targeting an on-time review; Anaphylm PDUFA date remains January 31, 2026, with launch targeted for Q1 2026 if approved .
Financing strengthened: $85M equity raise and a $75M commercial launch financing subject to approval/refinancing; cash stood at $129.1M at quarter-end, and debt refinancing expected to close by year-end .
Estimates context: Consensus revenue ~$12.94M and EPS $(0.133); reported revenue and EPS were slightly below consensus, reflecting heavier pre-commercial SG&A and the prior-year deferred revenue comparison base *. Values retrieved from S&P Global.
Potential stock catalysts: FDA’s on-time review and no AdComm, broadened Anaphylm patent estate (protection into 2037), and visible commercial readiness (sales infrastructure, payer engagement) .

What Went Well and What Went Wrong

What Went Well

“We are ready to go” for Q1 2026 launch contingent on approval; FDA targeting on-time review without an AdComm, improving regulatory visibility .
Cash runway extended: $85M equity raise plus $75M launch financing; CFO: capital supports operations through 2027 and debt refinancing progress is “in a good place” .
Patent estate strengthened: two new Anaphylm composition-of-matter patents; management expects Orange Book listing and meaningful blocking scope through at least 2037 .

What Went Wrong

EPS loss widened YoY to $(0.14) from $(0.13), and non-GAAP adjusted EBITDA loss increased YoY as SG&A rose for pre-launch activities; GAAP gross margin declined vs Q3 2024 .
Revenue down YoY to $12.807M from $13.542M due to prior-year deferred revenue recognition; despite this, manufacture & supply revenue rose YoY to $11.5M .
Base business headwinds persist: Suboxone declines continue to pressure manufacturing revenue mix, partially offset by growth in Sympazan and other collaborations .

Financial Results

Metric	Q3 2024	Q2 2025	Q3 2025
Revenue ($USD Millions)	$13.542	$10.003	$12.807
Diluted EPS ($USD)	$(0.13)	$(0.14)	$(0.14)
Non-GAAP Adjusted EBITDA ($USD Millions)	$(6.554)	$(9.344)	$(8.563)
GAAP Gross Margin (%)	67%	54%	65%

Revenue composition (selected):

Manufacture & Supply Revenue ($USD Millions): Q3 2024 $10.7; Q3 2025 $11.5 .

Operating metrics (Q3 2025):

R&D Expense: $4.530M (down YoY) .
SG&A Expense: $15.250M (up YoY; +pre-commercial, legal, regulatory) .
Cash and Cash Equivalents: $129.1M at 9/30/2025 .
Doses shipped (manufacturing operations): Q3 2025 43,801 (000’s) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue ($USD Millions)	FY 2025	$44–$50 (Q1 set; maintained in Q2)	$44–$50 (unchanged in Q3)	Maintained
Non-GAAP Adjusted EBITDA Loss ($USD Millions)	FY 2025	$47–$51 (Q1 set; maintained in Q2)	$47–$51 (unchanged in Q3)	Maintained

Notes: Guidance excludes certain Riverbend revenue previously contemplated and includes significant pre-approval launch spending and NDA-related fees for Anaphylm .

Earnings Call Themes & Trends

Topic	Q1 2025 (Q-2)	Q2 2025 (Q-1)	Q3 2025 (Current)	Trend
FDA/Regulatory	NDA submitted; pediatric PK supportive of 0.3mg autoinjector alignment	NDA accepted; PDUFA set 1/31/2026; preparing for potential AdComm	No AdComm; FDA targeting on-time review; site inspections without major findings	Increasing clarity; de-risking AdComm
Launch Readiness	Building market access/medical affairs; Q1 2026 launch plan	Continued commercial build; payer/advocacy engagement	Hiring district managers; allergist-focused strategy; targeted DTC (digital/print) later	Execution ramping
Financing/Liquidity	Cash $68.7M	Cash $60.5M	$85M equity + $75M launch financing; cash $129.1M; debt refi progressing	Strengthened liquidity
Patent/IP	—	—	Two new Anaphylm patents; expected Orange Book listing	IP position improved
X-US Expansion	Plan EU/CA submissions post NDA acceptance	Initial CA/EU regulatory engagements begun	Health Canada positive (no further studies); CA filing 1H26; EMA feedback Q1 2026	Advancing filings
Pricing & Access	—	—	“Price responsibly,” multi-access pathways (cash pay/co-pay), active payer PIIE; WAC not disclosed	Strategy defined; details pending
Competitive/Legal	—	—	Competitor citizen petition deemed “kitchen sink” and factually incorrect; no review impact	Addressed; no impact asserted
Supply Chain/Tariffs	Tariffs not impacting ops	Tariffs not impacting ops	U.S.-based mfg; tariffs not impacting near-term ops	Stable
Base Business	Suboxone declines offset by new collabs	Suboxone declines offset; Sympazan, Ondif, etc.	Stable demand (Invivure); growth in Brazil; Suboxone gradual decline	Mixed but resilient
R&D Execution	AQST-108 Phase 2a after Anaphylm launch	IND planned Q4 2025; study in 1H 2026	IND Q4 2025; 24-week Phase 2a, 40–60 pts	On track

Management Commentary

CEO on readiness and review: “We are ready to go… the FDA confirmed they are aiming for an on-time review… no advisory committee meeting” .
CFO on financing: “We completed an equity raise for $85 million… and a commercial launch financing of $75 million… capital that will support the company through 2027” .
CEO on patents: “Two new patents… focused on… rapid release of epinephrine… significant Orange Book-listable patents… expansive in blocking” .
CCO on pricing/access: “We plan to price responsibly with a patient-first approach… broad access including cash pay, copay savings, actively working with payers” .

Q&A Highlights

Competitor citizen petition: Management characterized it as “kitchen sink,” “factually incorrect,” and said they’ve seen “zero impact” on review timing .
Pricing/access strategy: WAC not disclosed; multi-pronged access programs; payer PIIE engagements underway; disciplined, allergist-focused commercialization to drive early adoption .
X-US partnership timing: License ex-U.S.; value improves closer to approval; CA filing 1H26; EMA feedback early Q1 2026 .
Market growth: Scripts +8.8% in Q3 and +7.5% YTD; 95% of scripts remain autoinjectors—primary share-capture focus .
Manufacturing capacity: ~150M film doses annual capacity; epinephrine market <10M doses; fully U.S.-based supply chain .

Estimates Context

Q3 2025 consensus vs reported:

Metric	Company Reported Actual	S&P Global Consensus
Revenue ($USD Millions)	$12.807	$12.9435*
Primary EPS ($USD)	$(0.14)	$(0.133)*
Estimates Coverage	—	EPS est. count: 8; Revenue est. count: 10*

Reported revenue slightly below consensus; reported EPS loss slightly larger than consensus, reflecting heavier SG&A for pre-launch and the absence of prior-year deferred revenue benefit *. Values retrieved from S&P Global.

Key Takeaways for Investors

Regulatory de-risking: No AdComm and an on-time FDA review aim reduce near-term approval uncertainty; maintain focus on PDUFA 1/31/2026 .
Liquidity and launch financing: $85M equity and $75M contingent launch financing support commercialization and pipeline through 2027; monitor debt refi closure by year-end .
Commercial strategy: Target high-volume allergists with disciplined, patient-centric messaging; expect DTC to be measured (digital/print), not TV-heavy in year one .
Competitive positioning: Patent estate broadened (to 2037) and strong physician/patient preference data support Anaphylm’s differentiation vs device-based options, if approved .
Base business resilience: Manufacturing collaborations and Brazilian partnership offset Suboxone declines; tariffs not impacting near-term operations .
Earnings setup: Expect continued elevated SG&A pre-approval; watch gross margin trajectory and adjusted EBITDA as pre-launch spend normalizes post-approval .
Near-term catalysts: FDA review updates, debt refinancing announcement, payer access progress, and ACAAI/medical community engagement could shape sentiment .

Appendix: Source Documents Read

Q3 2025 8-K (Item 2.02 with earnings press release and exhibits) .
Q3 2025 earnings call transcript –; duplicate version –.
Relevant press releases during Q3 2025 window: Leadership expansion –; fireside chat –; ACAAI Annual Meeting participation –; Anaphylm patent estate broadened –; earnings call scheduling –.
Prior quarters for trend analysis: Q2 2025 8-K (earnings press release and exhibits) –; Q1 2025 8-K (earnings press release and exhibits) –.

*Values retrieved from S&P Global.

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