ANI Pharmaceuticals : Corporate Presentation May 2026

Published: 2026-05-13 08:30:23 ET ANIP

Published on 05/13/2026 at 08:30 am EDT

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 measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.

Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense, interest expense, net, other expense (income), net, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expenses, and certain other items that vary in frequency and impact on ANI's results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided within the Appendix.

ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation,

including "with" and "without" tax provision information. As such, ANI's management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.

Adjusted non-GAAP Diluted Earnings per Share

ANI's management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI's results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.

Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilutive shares related to the convertible senior notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to offset the dilutive effect of the convertible senior notes recognized in the calculation of GAAP diluted EPS in this reporting period in full, and therefore shares have been excluded from the calculation of the Non-GAAP Adjusted Diluted Weighted-Average Shares outstanding.

Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI's results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings (loss) per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided within the Appendix.

ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such

reconciliation, including "with" and "without" tax provision information. As such, ANI's management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.

Other non-GAAP metrics

ANI's management also considers non-GAAP gross margin to be a financial indicator of ANI's operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI's results of operations. Management uses non-GAAP gross margin when analyzing Company performance. Non-GAAP cost of sales is defined as cost of sales (excluding depreciation and amortization), excluding non-cash stock-based compensation expense, amortization of certain purchase price adjustments, and certain other items that vary in frequency and impact on ANI's results of operations. Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization) divided by non-GAAP net revenues. Non-GAAP cost of sales and Non-GAAP gross margin should be considered in addition to, but not in lieu of, cost of sales and gross margin reported under GAAP.

ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP gross margin guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including "with" and "without" tax provision information. As such, ANI's management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results."

ANI's virtuous

cycle of growth

~$1.1B

Total net revenue in 2026

A profitable, high-growth biopharmaceutical organization transforming into a leading Rare Disease company

Projecting ~$1.1B in total net revenue in 2026

44% YoY increase in 2025

26% YoY increase in 2026(1)

Rare Disease business is primary focus

Expected to represent

~60% of total revenues in 2026

Lead asset, Cortrophin Gel, expected to provide substantial, durable multi-year growth opportunity

Generics business delivering strong cash flows enabled by superior R&D capabilities, operational execution, and U.S. manufacturing

Proven track record of delivering top- and bottom-line growth

2026E(3)

2025

2024

2023

2022

$316

$487

$614

$883

$1,080-$1,140

+37%

CAGR(2)

Total Company Net Revenues ($ millions)

2026E(3)

2025

2024

2023

2022

$56

$156

$134

$230

$285-$300

+51%

CAGR(2)

Adjusted Non-GAAP EBITDA ($ millions)(1)

Adjusted Non-GAAP EBITDA is a Non-GAAP financial measure. See Appendix for a reconciliation to the most directly comparable GAAP financial metric.

2022-2026 CAGR calculated using the midpoint of full year 2026 guidance provided by the Company on May 8, 2026. Based on 2026 financial guidance provided by the Company on May 8, 2026.

2026 priorities to drive long-term growth and value creation

Cortrophin Gel

ACCELERATE ANI'S TRANSFORMATION INTO

A LEADING RARE DISEASE COMPANY

ILUVIEN

Maximize multi-year growth opportunity by addressing significant unmet need across indications

Build on momentum in underpenetrated specialty indications in nephrology, neurology, rheumatology, ophthalmology and pulmonology

Recently onboarded majority of commercial team for acute gouty arthritis flares

Advance Phase 4 trial to establish further evidence supporting Cortrophin Gel in acute gouty arthritis flares

Continue to evaluate opportunities to enhance patient convenience

Return to growth

by leveraging the commercial and patient access initiatives

established in 2025

CONTINUED EXCELLENCE

IN GENERICS BUSINESS

Leverage superior R&D capabilities, operational execution, U.S. manufacturing footprint, and business development expertise to continue expanding cash generation

On track to Maintain current cadence of 10-15 launches annually

EXECUTE DISCIPLINED CAPITAL

ALLOCATION STRATEGY

Explore opportunities to expand scope and scale of Rare Disease business

Investing in dedicated organization for Cortrophin Gel in gout

Invest high single-digit percentage of Generics revenue into R&D

Q1 2026 and recent business highlights

Strong top- and bottom-line growth supported by solid performance across each business unit

Continued momentum in demand for Cortrophin Gel

Monetized innovative IP, creating new stream of royalty revenue

Raising 2026 financial guidance for total net revenues and adjusted EBITDA

Board authorized new $100M share repurchase program

Total Net Revenues ($M)(1)

Adjusted Non-GAAP EBITDA ($M)(2)

$128.2

$94.1

$103.0

$109.2

+20%

$237.5

+24%

$63.0

$50.7

$197.1

1Q25 1Q26

Totals may not sum due to rounding.

Adjusted Non-GAAP EBITDA is a Non-GAAP financial measure. See Appendix for a reconciliation to the most directly comparable GAAP financial metric. Includes Cortrophin Gel, ILUVIEN, Brands, and Brand royalties and other revenues.

Includes Generic pharmaceutical products and other generic revenues.

Harmony to utilize IP to expand its intellectual property estate for pitolisant and to develop a novel formulation

Low single digit royalties on pitolisant-based products

$10M payment upon achievement of certain development milestones; expected to be achieved in 2Q26 and 3Q26

$15M upfront license fee recognized in 1Q26

Out-licensed intellectual property to Harmony Biosciences in January 2026

2026 Financial Guidance5

Reflects significant top- and bottom-line growth

Metric

($ millions, except EPS)

Prior 2026 Guidance

Current 2026 Guidance

YoY Growth

Net Revenue (Total Company)

$1,055 - $1,115

22 - 29%

Cortrophin Gel Net Revenue

$540 - $575

55 - 65%

ILUVIEN Net Revenue

$78 - $83

4 - 11%

Adjusted Non-GAAP EBITDA(1)

$275 - $290

24 - 31%

Adjusted Non-GAAP Diluted EPS(1)(2)

$8.83 - $9.34

16 - 23%

2026 adjusted non-GAAP gross margin expected to be 59.9% - 60.9%(3)

Anticipates 21.5M - 21.8M shares outstanding for the purpose of calculating full year 2026 adjusted non-GAAP diluted EPS(4)

Adjusted Non-GAAP EBITDA, Adjusted Non-GAAP Diluted EPS, and Adjusted Non-GAAP Gross Margin are Non-GAAP financial measures.

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 during the period ("Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding"). Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions.

Blended royalty rate due to Merck for Cortrophin Gel net sales expected to be in high-20 percent range in 2026. Does not assume any share repurchases in 2026.

Based on 2026 financial guidance provided by the company on May 8, 2026

Rare Disease business represents primary driver of growth; expected to account for ~60% of revenues in 2026

Rare Disease Net Revenues ($ millions)

Cortrophin Gel ILUVIEN

+84%

$348

$75

$423

+51%(1)

$540 - $575

$78 - $83

$618 - $658

$42

$112

$230

$198

$32

2022 2023 2024(2) 2025 2026E(3)

Percent change calculated based on the midpoint of 2026 financial guidance range provided by the Company on May 8, 2026.

Alimera acquisition occurred in September 2024; ILUVIEN revenue only represents partial year of ownership. Represents 2026 financial guidance ranges provided by the Company on May 8, 2026.

Cortrophin Gel: lead rare disease asset

Acceleration in momentum across new patient starts and dispensed volumes

Broad growth across all targeted specialties: rheumatology, nephrology, neurology, pulmonology and ophthalmology

Prescribing in acute gouty arthritis flares expected to be a key growth driver in 2026; represents ~18% of total utilization

Potential for strong multi-year growth as key indications are significantly underpenetrated

Overall ACTH market growth driven by continued expansion into key indications

>$1.3B

+24%

CAGR

$1.0B

$684M

$594M

$558M

$537M

2021

2022

2023

2024

2025

2026(1)

+30%

+50%

+27%

-4%

-6%

YoY Growth

Purified Cortrophin® Gel

Acthar Gel

ACTH MARKET SALES

Expect continued strong multi-year growth potential driven by large market opportunity as key indications remain significantly underpenetrated

Proven ability to reach new HCPs and patients with approximately half of Cortrophin Gel prescribers naive to the ACTH category before prescribing Cortrophin Gel

© 2026 ANI Pharmaceuticals, Inc. 1. Based on the sum of 2026 Cortrophin Gel net revenue guidance and Keenova Therapeutics' 2026 guidance for Acthar Gel per its fourth quarter 2025 earnings release (March 31, 2026).

Cortrophin Gel has strong multi-year growth potential with addressable patient populations across indications significantly under-penetrated

Acute Gout Flares

Diagnosed ~9,900,0001

~36% receive

treatment annually2

1.5 - 2 average flares per year3

~8% receive an injectable flare treatment4

~500,000 addressable annual flares

Nephrotic Syndrome

Sarcoidosis

10-25% of patients require a second line therapy17-19

25-42.5% of patients are treated13,16

Diagnosed ~175,00013-15

Rheumatoid Arthritis

~100,000 addressable annual flares

Up to 30% of patients do not respond to a steroid12

17-25% experience a flare annually10,11

Diagnosed ~1,600,0009

Multiple Sclerosis Flares

Diagnosed ~750,0005

1-2.2 average flares per

year6,7

25% of patients do not respond to a steroid8

~300,000 addressable annual flares

(proteinuria reduction)

Diagnosed

~35,00020

12.5% - 20% of patients do not respond to a steroid21,22

* All references provided in appendix. Addressable patient populations shared for select indications. 14

Investing in Cortrophin Gel to build momentum in 2026 and beyond

Investing in high ROI

commercial initiatives

Focus efforts to continue momentum established in Nephrology, Neurology, Rheumatology and Pulmonology as the ACTH market expands

Expanding rare disease organization by ~90-people dedicated to gout that targets primary care and podiatrist offices, full organization expansion completed and operational by the end of June 2026

Realizing synergies with integrated ophthalmology team

Enhancing convenience

Launched Pre-Filled Syringe in 2025

Continuing to evaluate opportunities to enhance patient convenience

Generating scientific and clinical evidence

Advancing Phase 4 clinical trial of Cortrophin Gel in acute gouty arthritis flares

Robust pipeline of investigator-initiated trials across

disease states

Continued investment in preclinical data and publications

Cortrophin Gel Net Revenues

($ millions)

$42

$112

$198

+76%

$348

+60%(1)

$540 - $575

2022 2023 2024 2025 2026E(2)

Year-over-year growth calculated based on the midpoint of 2026 financial guidance range provided by the Company on May 8, 2026.

Represents 2026 financial guidance provided by the Company on May 8, 2026.

Capturing sizable additional opportunity in gout through commercial organization expansion

Acute Gout Flares

Diagnosed ~9,900,0001

~36% receive

treatment annually2

1.5 - 2 average flares per year3

~8% receive an injectable flare treatment4

~500,000 addressable annual flares

Large underpenetrated market opportunity

Focus on most severe patients:

~285,000 who are currently treated with injectables for their flares

Need for new treatments for those patients not well served by first line options

Co-morbidities may limit certain treatment options

Successful track record in Gout

Only approved ACTH therapy to treat acute gouty arthritis flares

In 2025, ran successful pilots across 10 territories in primary care and podiatry

Prefilled syringe and subcutaneous option for Cortrophin self-administration enables flare readiness, unlike most injectable options

Our approach to serving more patients

Rare Disease commercial organization expansion targeting high priority PCPs and podiatrists who see most severe acute gouty arthritis patients to be in the field by end of 2Q26

Majority of commercial team has

been onboarded

* All references provided in appendix. Addressable patient populations shared for select indications. 16

ILUVIEN is a long-acting ocular therapy approved for DME and chronic NIU-PS

36-months of continuous therapy via CONTINUOUS MICRODOSING of

fluocinolone acetonide (FAc) in patients with retinal disease

Diabetic Macular Edema (DME):

Chronic disease that is the leading cause of vision loss in diabetic patients; ~4% of diabetic patients develop clinically significant macular edema

>50,000 patients in the U.S. are not well served by anti-VEGF therapy;

<5,000 patient starts annually for DME in the U.S.

Strong global clinical evidence in DME supported by NEW DAY study results

Chronic non-infectious uveitis affecting the posterior segment (NIU-PS):

Inflammation of the eye that can lead to pain, visual impairment, and vision loss

>75,000 patients in the U.S. are candidates for treatment, and steroids are the standard of care; <5,000 patient starts annually for NIU-PS in the U.S.

Returning ILUVIEN to growth by leveraging established commercial and patient access initiatives

NEW DAY study results in DME published in Ophthalmology

Expect to present SYNCHRONICITY trial results in NIU-PS at medical meeting in 3Q 2026

Growing use of alternative access channels to navigate market access challenges for Medicare patients

Generics business driving strong cash flow generation with superior R&D capabilities, U.S. manufacturing footprint, and operational excellence

Robust, diversified pipeline and new product launch execution

Robust pipeline in place with goal to deliver ~10-15 new product launches annually; 6 products launched YTD; ANI holds #2 CGT filing position

Invest high single-digit percentage of Generics revenue into Generics R&D to support business

Diversified portfolio of ~125 product families and largest product expected

to account for less than approximately 6% of Generics revenues in 2026

Generics Net Revenues2 ($ millions)

+28%

$384

+12%

$301

$269

$210

Strong operational backbone with a focus on cost efficiency

Three U.S. based manufacturing sites with strong GMP track record; all sites currently in VAI or NAI status

Manufactured and supplied over 2.5 billion doses of therapeutics in last 12 months(1)

Systematic approach to reducing raw materials and finished goods costs and lean corporate spend

2022 2023 2024 2025

Per IQVIA NSP Sales data - MAT December 2025 data.

Reflects generic pharmaceutical products.

Disclaimer

ANI Pharmaceuticals Inc. published this content on May 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 13, 2026 at 12:29 UTC.