ANI Pharmaceuticals, Inc. · NASDAQ:ANIP
ANI Pharmaceuticals — Q3 2026 Earnings Presentation
39 slides from ANI Pharmaceuticals's earnings presentation, Nov 5, 2026
Slide 1: Q3 2026 Earnings Results & Offer to Acquire Egetis Therapeutics
© 2026 ANI Pharmaceuticals, Inc. 1 Q3 2026 Earnings Results & Offer to Acquire Egetis Therapeutics November 5, 2026
Slide 2: Forward-looking statements
© 2026 ANI Pharmaceuticals, Inc. 2 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements that are not historical
Slide 3: Presentation of financial information
© 2026 ANI Pharmaceuticals, Inc. 3 Presentation of financial information Non-GAAP Financial Measures Adjusted non-GAAP EBITDA ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful meas
Slide 4: Egetis Therapeutics offer
© 2026 ANI Pharmaceuticals, Inc. 4 Egetis Therapeutics offer This presentation includes discussion of our public offer for the shares, the convertible loan 2023:1 (the “Convertible”) and the warrants 2023/2033:1 (the “Warrants”) of Egetis, a Swedish public limited liability company (the “Offer”), wh
Slide 5: Agenda
© 2026 ANI Pharmaceuticals, Inc. 5 Agenda Opening Remarks – Nikhil Lalwani, CEO • ANI’s Strategy • Recent Business Highlights • Egetis Offer Overview MCT8 Deficiency & EMCITATE Overview – Mary Pao, M.D., Ph.D., CMO Rare Disease Commercial Update – Chris Mutz, Head of Rare Disease • EMCITATE Commerci
Slide 6: Opening Remarks
© 2026 ANI Pharmaceuticals, Inc. 6 Opening Remarks Nikhil Lalwani CHIEF EXECUTIVE OFFICER
Slide 7: 2026 strategic priorities to drive long-term growth
© 2026 ANI Pharmaceuticals, Inc. 7 2026 strategic priorities to drive long-term growth Accelerate transformation into leading Rare Disease company Continued excellence in Generics R&D and operations Execute disciplined capital allocation strategy RARE DISEASE BRA N D S G E N E R I C S ANI’s virtuous
Slide 8: Q3 2026 highlights
© 2026 ANI Pharmaceuticals, Inc. 8 Q3 2026 highlights 1. Totals may not sum due to rounding. 2. Adjusted Non-GAAP EBITDA is a Non-GAAP financial measure. See Appendix for a reconciliation to the most directly comparable GAAP financial metric. 3. Includes Cortrophin Gel, ILUVIEN, Brands, and Brand ro
Slide 9: Executing 2026 priorities: transformation to a leading rare disease company
© 2026 ANI Pharmaceuticals, Inc. 9 Executing 2026 priorities to drive long-term growth and value creation Accelerating transformation to a leading rare disease company $138.7M 3Q26 net revenues +36% YoY ✓ Existing specialties: continued momentum in 3Q26 ✓ Gout expansion: strong demand generation and
Slide 10: Executing 2026 priorities: Generics and capital allocation
© 2026 ANI Pharmaceuticals, Inc. 10 Executing 2026 priorities to drive long-term growth and value creation Continued excellence in Generics business Disciplined capital allocation strategy Generated 3Q26 Generics revenue of $104.5M, up 11% YoY Launched 16 generic products year-to-date Maintained #2
Slide 11: Offer to acquire Egetis Therapeutics advances ANI's transformation
© 2026 ANI Pharmaceuticals, Inc. 11 Offer to acquire Egetis Therapeutics advances ANI’s transformation into a leading Rare Disease company EMCITATE addresses a devastating rare disease with severe lifelong morbidity, and substantial caregiver burden, aligning with ANI’s goal to bring innovative ther
Slide 12: EMCITATE has strong fundamentals with significant growth potential
© 2026 ANI Pharmaceuticals, Inc. 12 EMCITATE has strong fundamentals with significant growth potential First and only FDA-approved treatment for peripheral thyrotoxicosis in patients with MCT8 deficiency, a rare, X-linked disorder characterized by severe CNS hypothyroidism and simultaneous periphera
Slide 13: Transaction financial terms
© 2026 ANI Pharmaceuticals, Inc. 13 Transaction financial terms Consideration • Cash tender offer of SEK 11.25 per share • Total offer value of SEK $5.6B (~$560M); net enterprise value of ~$434M reflects estimated net proceeds of Egetis’ PRV monetization(1) Financing • Funded by combination of exist
Slide 14: MCT8 Deficiency & EMCITATE Overview
© 2026 ANI Pharmaceuticals, Inc. 14 MCT8 Deficiency & EMCITATE Overview Mary Pao, M.D., Ph.D. CHIEF MEDICAL OFFICER
Slide 15: MCT8 deficiency is an ultra-rare endocrinologic disease
© 2026 ANI Pharmaceuticals, Inc. 15 MCT8 deficiency is an ultra-rare, endocrinologic disease characterized by severe CNS hypothyroidism and simultaneous peripheral thyrotoxicosis Caused by mutations in the SLC16A2 gene, located on the X-chromosome1 The birth incidence has been estimated to be 1 in 7
Slide 16: Profound disabilities compound across systems, requiring lifelong 24-hour care
© 2026 ANI Pharmaceuticals, Inc. 16 With MCT8 deficiency, profound intellectual and physical disabilities compound across systems, requiring lifelong 24-hour care Hypothyroid Symptoms (low CNS T3) Hyperthyroid Symptoms (high peripheral T3) Brain & Cognition Global developmental delay (speech and cog
Slide 17: Mechanism of action of EMCITATE
© 2026 ANI Pharmaceuticals, Inc. 17 Mechanism of action: EMCITATE restores thyroid hormone signaling without requiring the MCT8 transporter to enter the cell 1 Restores thyroid hormone signaling in the brain 2 Reduces serum T3 levels which cause thyrotoxicosis in the body How EMCITATE Works
Slide 18: Clinical data supporting EMCITATE's FDA approval
© 2026 ANI Pharmaceuticals, Inc. 18 Clinical data supporting EMCITATE’s FDA approval for the treatment of peripheral thyrotoxicosis associated with MCT8 deficiency ReTRIACt (Study 1) Randomized, double-blind, placebo-controlled withdrawal with rescue, 30 days, N = 15 RATE OF T3 CHANGE 1.5x faster ri
Slide 19: Additional analysis from three sources of real-world evidence
© 2026 ANI Pharmaceuticals, Inc. 19 Additional analysis from three sources of real-world evidence Not included in U.S. Prescribing Information EMC COHORT STUDY EMC SURVIVAL STUDY U.S. EXPANDED ACCESS PROGRAM N = 67 N > 600 N = 30 (at time of NDA) • Real-world, retrospective cohort study -up to 6 yea
Slide 20: Rare Disease Commercial Update
© 2026 ANI Pharmaceuticals, Inc. 20 Rare Disease Commercial Update Chris Mutz HEAD OF RARE DISEASE
Slide 21: Offering hope to MCT8 deficiency patients and their families
© 2026 ANI Pharmaceuticals, Inc. 21 Offering hope to MCT8 deficiency patients and their families Globally, over 300 patients with MCT8 deficiency are already receiving EMCITATE through Managed Access Program, Expanded Access Program Now commercially available in the U.S. and EU
Slide 22: EMCITATE: first and only FDA-approved therapy for MCT8 deficiency
© 2026 ANI Pharmaceuticals, Inc. 22 EMCITATE: The first and only FDA-approved therapy for MCT8 deficiency APPROVED BY THE FDA September 28, 2026 INDICATION EMCITATE® (tiratricol) is a thyroid hormone receptor agonist indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric pa
Slide 23: Initial patient identification provides foundation for U.S. launch
© 2026 ANI Pharmaceuticals, Inc. 23 Initial patient identification concentrated at 17 sites provide strong foundation for U.S. launch 1,000+ Estimated prevalent U.S. population 100+ Validated patients today Unique, actively managed patients, with confirmed mutation, including responsible clinic / tr
Slide 24: Combined Egetis and ANI capabilities to drive successful launch
© 2026 ANI Pharmaceuticals, Inc. 24 Combined Egetis and ANI capabilities to drive successful launch Experienced commercial and medical affairs team hired and onboarded Patient support program in partnership with PANTHERx® Rare in place Strong relationships with patients, caregivers and advocacy grou
Slide 25: ACTH market sales and growth
© 2026 ANI Pharmaceuticals, Inc. 25 2021 2022 2023 2024 2025 $594M $558M $537M $684M $1.0B ACTH MARKET SALES -6% -4% +27%YoY Growth +50% Acthar Gel Purified Cortrophin® Gel $1.3B +28% 2026e(1) Overall ACTH market growth driven by continued expansion into key indications • Expect continued strong mul
Slide 26: Cortrophin Gel addressable patient populations across indications
© 2026 ANI Pharmaceuticals, Inc. 26 Diagnosed ~9,900,0001 ~500,000 addressable annual flares ~285,000 addressable patients Acute Gout Flares Cortrophin Gel has strong multi-year growth potential with addressable patient populations across indications significantly under-penetrated ~36% receive treat
Slide 27: Cortrophin Gel 3Q26 performance
© 2026 ANI Pharmaceuticals, Inc. 27 Cortrophin Gel 3Q26 performance Strong demand generation in gout expansion 40% of prescribers initiated 2+ cases +67% growth in new prescriber base vs. 2Q26 2x new patient cases vs. 2Q26 • Balanced demand from podiatrists and primary care physicians • Expanding sp
Slide 28: Returning ILUVIEN to growth across global markets
© 2026 ANI Pharmaceuticals, Inc. 28 Returning ILUVIEN to growth across global markets New data support growth in NIU-PS indication with a focus on retina specialists Safety consistent with the known profile of corticosteroid implants; IOP and cataract monitoring remain key considerations for ongoing
Slide 29: Financial Overview
© 2026 ANI Pharmaceuticals, Inc. 29 Financial Overview Stephen Carey CHIEF FINANCIAL OFFICER
Slide 30: 3Q 2026 revenues by product
© 2026 ANI Pharmaceuticals, Inc. 30 Metric ($ millions) 3Q 2026 Revenues $138.7 36% $22.3 34% $108.4 10% $11.5 N/A $10.0 (7%) Cortrophin Gel ILUVIEN(1) Generics and other Brand royalties and other revenue Brands $290.8 28%Total net revenues 1. NIU-PS indication was merged into the ILUVIEN label in m
Slide 31: 3Q 2026 Financial Results
© 2026 ANI Pharmaceuticals, Inc. 31 Metric1 ($ millions, except EPS) 3Q 2026 Financial Results $290.8 28% $111.0 20% 61.8% 260 bps $96.5 28% $83.3 40% Total net revenues Non-GAAP cost of sales Non-GAAP gross margin (%) Non-GAAP total operating expenses Adjusted Non-GAAP EBITDA $2.70 32%Adjusted Non-
Slide 32: 2026 financial guidance
© 2026 ANI Pharmaceuticals, Inc. 32 1. Adjusted Non-GAAP EBITDA and Adjusted Non-GAAP Diluted EPS are Non-GAAP financial measures. 2. For full year 2026 guidance, Adjusted Non-GAAP Diluted EPS is defined as adjusted Non-GAAP net income divided by the diluted weighted average shares outstanding durin
Slide 33: Closing Remarks
© 2026 ANI Pharmaceuticals, Inc. 33 Closing Remarks Nikhil Lalwani CHIEF EXECUTIVE OFFICER
Slide 34: Executing across strategic priorities to support continued growth
© 2026 ANI Pharmaceuticals, Inc. 34 2026 Rare Disease revenues(1) >50% of total revenue Executing across strategic priorities to support continued growth and transformation into a leading Rare Disease company 1. Based on the midpoint of 2026 financial guidance ranges provided by the Company on Novem
Slide 35: Appendix
© 2026 ANI Pharmaceuticals, Inc. 35 Appendix
Slide 36: Adjusted Non-GAAP EBITDA calculation and reconciliation
© 2026 ANI Pharmaceuticals, Inc. 36 Adjusted Non-GAAP EBITDA calculation and US GAAP to Non-GAAP reconciliation
Slide 37: Adjusted Non-GAAP diluted EPS calculation and reconciliation
© 2026 ANI Pharmaceuticals, Inc. 37 Adjusted Non-GAAP diluted earnings per share calculation and US GAAP to Non-GAAP reconciliation 1. Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities. 2. Non-GAAP Adjusted Diluted Weighted-Aver
Slide 38: Reconciliation of certain US GAAP to Non-GAAP financial measures
© 2026 ANI Pharmaceuticals, Inc. 38 Reconciliation of certain US GAAP to Non-GAAP financial measures
Slide 39: References for Cortrophin Gel Addressable Patient Population
© 2026 ANI Pharmaceuticals, Inc. 39 References for Cortrophin Gel Addressable Patient Population Gout 1. Singh G, Lingala B, Mithal A. Gout and hyperuricaemia in the USA: prevalence and trends. Rheumatology (Oxford). 2019 Dec 1;58(12):2177-2180. doi: 10.1093/rheumatology/kez196. PMID: 31168609 2. Th