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AP

ANI PHARMACEUTICALS INC (ANIP)·Q3 2025 Earnings Summary

Executive Summary

  • Record quarter with revenue of $227.8M, adjusted non-GAAP EPS of $2.04 and adjusted EBITDA of $59.6M; management raised FY25 guidance across revenue, EBITDA and EPS while lowering ILUVIEN guidance and adjusted gross margin due to mix .
  • Rare Disease momentum: Cortrophin Gel revenue grew 93.8% YoY to $101.9M on record new patient starts; prefilled syringe accounted for ~70% of new cases; management expects sequential Cortrophin growth in Q4 .
  • Generics outperformed on a partnered launch (lower margin due to profit-sharing), lifting Q3; management guides Q4 Generics down sequentially on new competition in that product’s market .
  • Retina under pressure: ILUVIEN revenue was $16.6M as Medicare access issues persisted; coverage progressing (6 of 7 MACs updated NIU-PS policy), and adoption for NIU-PS began, but FY25 ILUVIEN/YUTIQ guidance was cut to $73–$77M .
  • S&P Global Wall Street consensus for Q3 2025 (revenue, EPS) was unavailable via our tool; beat/miss vs estimates cannot be assessed (consensus unavailable) (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Cortrophin strength and execution: “Record revenue and adjusted EBITDA,” driven by Rare Disease and Generics, with Cortrophin nearly doubling YoY; CEO reiterated belief in “strong multi-year growth potential” on execution, evidence generation and convenience initiatives .
  • Prefilled syringe and salesforce leverage: Prefilled syringe reached ~70% of new cases; expanded salesforce improved coverage across neurology/rheumatology/nephrology; ophthalmology volumes +42% sequentially .
  • Generics upside: A partnered generic launch in H2 of Q3 drove 20.6% YoY Generics growth and lifted total results; management raised FY25 total revenue, EBITDA and EPS guidance accordingly .

What Went Wrong

  • Retina headwinds: ILUVIEN revenue softened on reduced Medicare patient access and YUTIQ inventory usage; FY25 ILUVIEN/YUTIQ guidance reduced to $73–$77M from $87–$93M .
  • Mix impact on margin: Non-GAAP gross margin declined YoY to 59.2% on product mix, including the lower-margin partnered generic; FY25 adjusted GM lowered to 61–62% from 63–64% .
  • Near-term Generics normalization: Management expects Q4 Generics down sequentially due to competition entering the partnered product market, tempering the Q3 surge .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($M)$148.332 $197.122 $211.371 $227.813
GAAP Diluted EPS ($)$(1.27) $0.69 $0.36 $1.13
Adjusted non-GAAP Diluted EPS ($)$1.34 $1.70 $1.80 $2.04
Adjusted non-GAAP EBITDA ($M)$35.104 $50.749 $54.077 $59.601
GAAP Gross Margin %57.5% 62.9% 64.7% 59.0%
Non-GAAP Gross Margin %59.9% 63.1% 64.9% 59.2%

Segment revenue ($M)

SegmentQ3 2024Q1 2025Q2 2025Q3 2025
Cortrophin Gel$52.555 $52.850 $81.647 $101.850
ILUVIEN + YUTIQ$3.871 $16.109 $22.316 $16.600
Rare Disease total$56.426 $68.959 $103.963 $118.450
Brands$9.195 $25.123 $13.195 $10.675
Generics$78.223 $98.678 $90.297 $94.375
Royalties & other$4.488 $4.362 $3.916 $4.313
Generics & other total$82.711 $103.040 $94.213 $98.688
Total net revenue$148.332 $197.122 $211.371 $227.813

Selected KPIs (Q3 2025)

KPIQ3 2025
Cash & Equivalents$262.6M
Principal Value of Outstanding Debt$633.1M
Cash from Operations (quarter)$44.1M
Net Leverage (TTM adj. EBITDA)1.7x
TTM Adjusted non-GAAP EBITDA$214.5M
Cortrophin prefilled syringe share of new cases~70%
Cortrophin gout share of use>15%
Ophthalmology Cortrophin volumes (seq)+42% vs Q2
ILUVIEN coverage6/7 MACs updated NIU-PS policy

Guidance Changes

MetricPeriodPrevious Guidance (Aug 8)Current Guidance (Nov 7)Change
Total Company Net RevenueFY 2025$818–$843M $854–$873M Raised
Cortrophin Gel Net RevenueFY 2025$322–$329M $347–$352M Raised
ILUVIEN + YUTIQ Net RevenueFY 2025$87–$93M $73–$77M Lowered
Adjusted non-GAAP EBITDAFY 2025$213–$223M $221–$228M Raised
Adjusted non-GAAP Diluted EPSFY 2025$6.98–$7.35 $7.37–$7.64 Raised
Adjusted Gross MarginFY 202563%–64% 61%–62% Lowered
GAAP Effective Tax RateFY 202524%–25% 21%–22% Lowered
Adjusted Diluted SharesFY 202520.3–20.5M 20.5–20.7M Slightly Higher

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
Cortrophin demand & salesforceQ1: Record prescriptions/new starts; early evidence of broader prescriber base; salesforce expansion planned/underway . Q2: Expansion in Q1 drove growth across core specialties .Record new starts/cases; growth across targeted specialties; continued ROI from expanded salesforce .Up
Prefilled syringeQ1: FDA approval; launched in April; positive early feedback . Q2: Ramping across indications .~70% of new cases initiated; material growth driver .Up
ILUVIEN access & adoptionQ1: Combined label with NIU-PS; Medicare access issues; plan to improve . Q2: Strengthened promo/education; continued Medicare access challenges .Revenue softer; adoption for NIU-PS began; 6/7 MACs updated policy; exploring Part D/Specialty Pharmacy path .Mixed
Generics executionQ1: Strong, incl. prucalopride w/ exclusivity . Q2: Continued strength from launches and operations .Partnered launch drove Q3; lower margin due to profit share; Q4 sequential decline expected on competition .Up (near-term), then normalize
Supply chain & tariffsQ1: >90% of revenue from U.S.-made products; <5% direct China exposure; watching industry-specific tariffs .Ongoing; no new issues disclosed.Stable
R&D/external evidenceQ1: Prefilled syringe rollout; retina label update . Q2: NEW DAY (DME) data presented at ASRS .Phase 4 gout trial ongoing; broader preclinical publications; continued conference presence .Up
Regulatory/legal (retina)Q1: ILUVIEN label merged w/ NIU-PS . Q2: Fully transitioned U.S. promotion to ILUVIEN .Adoption begun; payer coverage updated for NIU-PS .Up
Capital structure & M&A—Net leverage 1.7x; exploring BD to scale Rare Disease; Q3 intangible testing passed .Active exploration

Management Commentary

  • Strategy and performance: “Record revenue and adjusted EBITDA… strength of our Rare Disease and Generics business units… Based on our strong third quarter performance, we are again raising our top- and bottom-line 2025 financial guidance.” — Nikhil Lalwani, CEO .
  • Cortrophin growth drivers: “We continue to believe in the strong multi-year growth potential of Cortrophin… driving this growth through strong commercial execution, investment in evidence generation… and initiatives to enhance patient convenience.” — Nikhil Lalwani .
  • Mix and margins: “Non-GAAP gross margin was 59.2%… decrease… due to product mix, including lower gross margins on a partnered generic product that launched in the third quarter.” — Stephen Carey, CFO .
  • FY25 margin guidance reset: “We are revising our full fiscal year guidance for Adjusted Gross Margin to 61%–62%… driven by the revised revenue mix with lower ILUVIEN and higher Generics forecast.” — Stephen Carey .
  • Capped call/EPS mechanics: Non-GAAP adjusted diluted shares exclude dilutive shares from 2029 converts when offset by capped call (502k shares excluded in Q3) — company disclosure .

Q&A Highlights

  • IRA/Medicare Part D impact: IRA redesign modestly net positive for Cortrophin in 2025 (affordability/uptake offset by mandatory manufacturer payments); growth expected to be driven by underpenetrated addressable populations in 2026+ .
  • Partnered generic: Name undisclosed; sole generic “for a period” in Q3; competition entered in Q4, prompting sequential decline; product carries lower GM due to profit-share .
  • Cortrophin drivers/inventory: Growth driven by underlying demand across specialties; gout now >15% of use; prefilled syringe ~70% of new cases; no inventory or gross-to-net anomalies cited .
  • Pulmonology and BD: Pulmonology is smaller but growing with higher vials per patient; BD focus on late-stage/commercial assets synergistic with call points/rare disease infrastructure; no rush to transact .
  • ILUVIEN access: Six of seven MACs updated NIU-PS coverage; practices exploring Medicare Part D via specialty pharmacy pathway (similar to Cortrophin) .
  • Durability/competition: ACTH products viewed as difficult to genericize (porcine-derived, complex formulation); IP extended into 2040s .
  • Label expansion: FDA would require Phase 3 for additional indications (cost/benefit calculus) .
  • KPIs/salesforce and accounting: Competitive sensitivity on KPIs; ILUVIEN intangibles passed Q3 testing .

Estimates Context

S&P Global Wall Street consensus for Q3 2025 was unavailable via our tool; we cannot assess beat/miss vs consensus for revenue or EPS (consensus unavailable) (S&P Global data unavailable).

MetricQ3 2025 ActualS&P Global Consensus
Revenue ($M)$227.813 N/A – unavailable (S&P Global data unavailable)
GAAP Diluted EPS ($)$1.13 N/A – unavailable (S&P Global data unavailable)
Adjusted non-GAAP Diluted EPS ($)$2.04 N/A – unavailable (S&P Global data unavailable)

Key Takeaways for Investors

  • Rare Disease is now the primary growth engine (Cortrophin up 93.8% YoY to $101.9M; FY25 Cortrophin guidance raised to $347–$352M); sustained execution plus prefilled syringe adoption underpin multi-year growth .
  • Guidance reset higher on top and bottom line (revenue, EBITDA, EPS), but adjusted gross margin lowered to 61–62% on mix (lower ILUVIEN, higher Generics, partnered generic lower GM) — a watch item for FY25/26 modeling .
  • Near-term: Expect Q4 Generics revenue to decline sequentially as competition enters the partnered product market; management still expects sequential Cortrophin growth in Q4 .
  • Retina recovery is a 2026+ story: FY25 ILUVIEN/YUTIQ guidance cut; however, NIU-PS label adoption is underway, payer coverage is improving, and alternative access pathways (Part D via specialty pharmacy) are being explored .
  • Balance sheet optionality: $262.6M cash, net leverage ~1.7x TTM adj. EBITDA; management is evaluating BD/M&A to scale Rare Disease, but not compelled to transact near term .
  • Technical EPS note: Capped call offsets convert dilution; non-GAAP adjusted diluted shares exclude those dilutive shares when in-the-money and below cap (502k shares excluded in Q3), affecting EPS modeling .
  • Catalysts: Continued Cortrophin share gains (gout, ophthalmology), Q4 sequential dynamics (Cortrophin up; Generics down), ILUVIEN coverage and access updates, and progression of the Phase 4 gout study and evidence publications .