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AP

ANI PHARMACEUTICALS INC (ANIP)·Q1 2025 Earnings Summary

Executive Summary

  • Record Q1 revenue of $197.1M (+43.4% YoY) and adjusted EPS of $1.70; GAAP diluted EPS was $0.69. Management raised FY25 revenue, EBITDA and adjusted EPS guidance, signaling confidence in full-year trajectory .
  • Cortrophin Gel delivered $52.9M (+43.1% YoY) on record new patient starts and prescriber expansion; Generics hit $98.7M (+40.5% YoY), aided by first-to-market prucalopride exclusivity. ILUVIEN/YUTIQ posted $16.1M amid Medicare Part B co-pay foundation funding headwinds and sales force turnover .
  • Gross margin mixed: GAAP 62.9% (down ~130 bps YoY), non-GAAP 63.1% (down ~130 bps YoY) on mix/royalty-bearing products; SG&A up with Alimera integration and rare disease investment .
  • Catalysts: FDA label expansion for ILUVIEN to include NIU-PS, royalty obligation buyout on ILUVIEN/YUTIQ, launch of Cortrophin prefilled syringe; FY25 guidance raised across revenue/EBITDA/EPS. Near-term watch: Medicare access dynamics and prucalopride exclusivity phasing .

What Went Well and What Went Wrong

What Went Well

  • Cortrophin Gel momentum: “record number of prescriptions and new patient starts” with 40% of prescribers naïve to ACTH; ophthalmology volume up ~50% QoQ .
  • Generics execution: $98.7M (+40.5% YoY) driven by new launches including first-to-market prucalopride (180-day exclusivity) and strong base business .
  • Strategic retina moves: FDA approved expanded ILUVIEN label to add NIU-PS; buyout of 3.125% perpetual royalty on ILUVIEN/YUTIQ enhances economics and flexibility .

What Went Wrong

  • Retina headwinds: U.S. ILUVIEN/YUTIQ demand impacted by reduced co-pay foundation funding under Medicare Part B, sales force turnover and seasonality; management is shifting to specialty pharmacy/Part D pathways and expects improvement in Q2 .
  • Gross margin compression YoY (GAAP 62.9%, non-GAAP 63.1%) from mix with higher royalty-bearing products (including Cortrophin) .
  • SG&A elevated (+59.4% GAAP; +56.5% non-GAAP) on Alimera integration, expanded ophthalmology team, and increased commercial investment .

Financial Results

Consolidated Performance vs Prior Quarters

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$148.3 $190.6 $197.1
GAAP Diluted EPS ($)$(1.27) $(0.55) $0.69
Adjusted non-GAAP Diluted EPS ($)$1.34 $1.63 $1.70
GAAP Gross Margin (%)57.5% 57.9% 62.9%
Non-GAAP Gross Margin (%)59.9% 63.5% 63.1%
Adjusted non-GAAP EBITDA ($USD Millions)$35.1 $50.0 $50.7

Segment and Product Breakdown

Metric ($USD Thousands)Q4 2024Q1 2025
Cortrophin Gel$59,400 $52,850
ILUVIEN and YUTIQ$27,643 $16,109
Rare Disease total net revenues$87,043 $68,959
Brands$19,842 $25,123
Rare Disease and Brands total$106,885 $94,082
Generics$78,600 $98,678
Royalties & other services$5,089 $4,362
Generics & Other total$83,689 $103,040
Total net revenues$190,574 $197,122

KPIs and Balance Sheet

KPIQ4 2024Q1 2025
Cash & Equivalents ($USD Thousands)$144,861 $149,802
Net Accounts Receivable ($USD Thousands)$221,726 $220,334
Principal Value of Outstanding Debt ($USD Thousands)$639,200 $637,200
Cash from Operations YTD ($USD Thousands)$64,000 $35,000
Gross Leverage (x)—3.5x
Net Leverage (x)—2.7x; ~2.4x forward at FY25 EBITDA midpoint

Q1 2025 vs Consensus Estimates

MetricQ1 2025 ActualS&P Global ConsensusSurprise
Revenue ($USD Millions)$197.1 N/AN/A
EPS (Adjusted non-GAAP) ($)$1.70 N/AN/A
Note: S&P Global consensus estimates were unavailable via our feed at time of analysis; we will update this section when data is accessible.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Revenue (Total Company)FY 2025$756M – $776M $768M – $793M Raised
Adjusted Non-GAAP EBITDAFY 2025$190M – $200M $195M – $205M Raised
Adjusted Non-GAAP Diluted EPSFY 2025$6.12 – $6.49 $6.27 – $6.62 Raised
Cortrophin Gel Net RevenueFY 2025$265M – $274M $265M – $274M Maintained
ILUVIEN & YUTIQ Net RevenueFY 2025$97M – $103M $97M – $103M Maintained
Generics Revenue GrowthFY 2025Low double-digit Mid double-digit Raised
Additional guidance points: adjusted gross margin 63–64%; tax rate ~25% GAAP and 26% for non-GAAP adjustments; diluted shares for EPS calc ~20.1–20.4M .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Cortrophin demand & prescribersRecord Q3 Cortrophin revenue; building prescriber base; sNDA for prefilled syringe submitted Record Q4 Cortrophin $59.4M; 40% prescribers naïve; acute gout ~15% of usage Record new patient starts; $52.9M; 40% prescribers naïve; ophthalmology volume +~50% QoQ Strengthening multi-year trajectory
Retina franchise (ILUVIEN/YUTIQ)Alimera acquisition closed; initial $3.9M revenue; integration plans PAS to add NIU-PS to ILUVIEN label expected Q2; supply security actions FDA approved NIU-PS label; U.S. demand impacted by Medicare co-pay foundation funding and turnover; April demand improved Near-term headwinds; improving through Q2
Generics launches & prucalopride+10.8% YoY generics; multiple launches Q4 +9.4% generics; prucalopride launched late Dec Q1 +40.5% generics; prucalopride 180-day exclusivity supporting strength; Q2 phasing down before June 26 Strong Q1; normalization in Q2
Tariffs/macro positioning——<90% revenues manufactured in U.S.; <5% direct China reliance; awaiting tariff framework New risk monitored; favorable U.S. footprint
R&D/execution (Cortrophin)Prefilled syringe sNDA progression Prefilled syringe development noted Prefilled syringe FDA approval (Feb) and April launch; Phase IV gout trial planned; ARVO preclinical uveitis data Advancing evidence & convenience
Legal/Regulatory——CG Oncology royalty litigation trial set for July 21, 2025 Upcoming legal catalyst

Management Commentary

  • “We are pleased to report another strong quarter, with record revenue, adjusted EBITDA and adjusted EPS driven by continued strong demand for Cortrophin Gel, exceptional performance for our Generics business, and increased demand for our Brands portfolio.” — Nikhil Lalwani, CEO .
  • Retina dynamics: “demand for our retina assets ILUVIEN and YUTIQ was impacted by Medicare-related market access challenges, turnover in our ophthalmology sales team, and seasonality… demand has accelerated in the second quarter.” — Nikhil Lalwani .
  • U.S. manufacturing advantage: “over 90% of our revenues coming from finished goods manufactured in the U.S. and less than 5%… direct reliance on China.” — Nikhil Lalwani .
  • EBITDA/EPS guidance cadence: “we expect second quarter adjusted EBITDA to be lower as compared to the first quarter followed by a return to sequential growth in the third and fourth quarters.” — Stephen Carey, CFO .

Q&A Highlights

  • Cortrophin prefilled syringe impact: Early HCP feedback positive; convenience reduces administration steps; team added ~20 reps across indications, gaining traction; no plans to add more reps in 2025 currently .
  • ILUVIEN/YUTIQ full-year confidence: International (~30%) on track; U.S. pathways pivoting to specialty pharmacy/Part D; expect back-half improvement if foundation support resumes; reiterating $97–$103M guidance .
  • Prucalopride phasing: Strong Q1 contribution; Q2 lower as inventory normalizes ahead of June 26 end of exclusivity; generics Q2 lower than Q1 then company returns to sequential growth in H2 .
  • Payer landscape for Cortrophin: Collaboration with PBMs/payers continues as category grows; differentiation via new presentations and evidence generation (Phase IV gout, ophthalmology data) .
  • Tariff readiness and capacity: Spare capacity across NJ/MN plants; well-positioned to supply U.S. market under potential pharma-specific tariffs .

Estimates Context

S&P Global consensus for Q1 2025 revenue and EPS was unavailable via our feed at the time of analysis; we cannot assess beats/misses versus Street. We will revisit when consensus data is accessible.

Key Takeaways for Investors

  • FY25 outlook strengthened: Bold raise to total revenue ($768–$793M), EBITDA ($195–$205M), and adjusted EPS ($6.27–$6.62) reflects broad-based momentum; watch Q2 dip from generics phasing before H2 reacceleration .
  • Cortrophin Gel remains the growth engine: Record new patient starts, prescriber expansion (40% naïve to ACTH), and convenience upgrades (prefilled syringe) underpin multi-year trajectory; management expects sequential quarterly growth in FY25 .
  • Retina franchise is a swing factor near term: Medicare Part B co-pay dynamics and sales force turnover weighed on Q1, but FDA NIU-PS label expansion and commercial refinements support recovery; April demand improved and FY guide maintained .
  • Generics strength visible but transitory around exclusivity: Prucalopride exclusivity boosted Q1; Q2 expected lower before normalizing; full-year generics outlook raised to mid-double-digit growth .
  • Margin mix watch: GAAP/non-GAAP gross margins declined YoY in Q1 on royalty-bearing mix; management expects 63–64% adjusted gross margin for FY25, with rare disease mix favorability in H2 .
  • Balance sheet capacity and leverage: $149.8M cash, net leverage 2.7x (forward ~2.4x); royalty buyout enhances ILUVIEN/YUTIQ economics; capacity to invest in growth and manage potential tariff shocks .
  • Upcoming catalysts: CG Oncology royalty litigation trial (July 21, 2025), continued Cortrophin evidence generation (Phase IV gout), and ILUVIEN marketing under combined DME/NIU-PS label .