March 2024

© 2024 ANI Pharmaceuticals, Inc.

1

Disclaimer

To the extent any statements made in this presentation deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company's generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: Cortrophin Gel is our first rare disease pharmaceutical product; to the extent we are not able to continue to achieve commercial success with this product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; our approved products, including Cortrophin Gel, may not achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; acquisitions and other investments could disrupt our business and harm our financial position and operating results; the limited number of suppliers for our active pharmaceutical ingredients could result in lengthy delays in production if we need to change suppliers; delays or failure in obtaining or maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA and other regulatory agencies, including drug recalls; acceptance of our products at levels that will allow us to achieve profitability; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; our dependence on single source suppliers of ingredients due to the time and cost to validate a second source of supply; our ability to develop, license or acquire, and commercialize new products; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; whether we experience difficulties closing a sale transaction with a buyer for the plant and property resulting from the closure of our Oakville, Ontario manufacturing plant; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, or conflicts relating to attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, such as COVID-19, and other risks and uncertainties that are described in ANI's Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.

More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this presentation speak only as of the date of this presentation and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Non-GAAP Financial Measures

This presentation includes certain non-GAAP financial measures, including Adjusted EBITDA and Adjusted Earnings Per Share (Adjusted EPS), that management reviews to evaluate its business, measure its performance and make strategic decisions. Management believes that such non-GAAP financial measures provide useful information to investors and others in understanding and evaluating its operating results in the same manner as management. Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results. Adjusted non-GAAP EBITDA is defined as net income (loss), excluding tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over cost of acquired inventory, non-cashstock-based compensation expense, Novitium transaction expenses, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI's results of operations. Adjusted non-GAAP net income (loss) is defined as net income (loss), plus the excess of fair value over cost of acquired inventory sold, non-cashstock-based compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, contingent consideration fair value adjustment, and certain other items that vary in frequency and impact on ANI's results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Adjusted non-GAAP diluted (loss)/earnings per share is defined as adjusted non-GAAP net income (loss) divided by the diluted weighted average shares outstanding during the period. Adjusted EBITDA, Adjusted EPS and any other ratio or metrics derived therefrom are financial measures not calculated in accordance with GAAP and should not be considered as substitutes for revenue, net income, operating profit, or any other operating performance measure calculated in accordance with GAAP. Using these non-GAAP financial measures to analyze the business would have material limitations because their calculations are based on the subjective determination of management regarding the nature and classification of events and circumstances that investors may find significant. In addition, although other companies in its industry may report measures titled Adjusted EBITDA or similar measures, such non-GAAP financial measures may be calculated differently from how management calculates its non- GAAP financial measures, which reduces their overall usefulness as comparative measures. Because of these limitations, you should consider Adjusted EBITDA and Adjusted EPS alongside other financial performance measures, including net income and other financial results presented in accordance with GAAP. Please refer to the Appendix in this presentation for a reconciliation of the non-GAAP financial measure to the most directly comparable GAAP measure. ANI is not providing a reconciliation for the forward-looking full year 2023 adjusted non-GAAP measures 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.

© 2024 ANI Pharmaceuticals, Inc.

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ANI Pharmaceuticals: Rare Disease and Generics drive robust profitable growth; Established Brands adds strong cash flow

Key Growth Drivers

Rare Disease

Generics with

business with lead

enhanced R&D

asset Purified

capabilities driving

Cortrophin Gel

new product

and expansion

launches; supply

through M&A

reliability

Established

Brands

1. As of 12/31/2023

© 2024 ANI Pharmaceuticals, Inc.

Financial Strength

$487M +54%

2023 year-over-year

Revenue revenue growth

140%

$221M

cash(1)

Adjusted non-

$119M

GAAP EBITDA

growth

Cash flow from

operations

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Q4 2023: Another strong quarter, capping off a record 2023

Highlights

  • Continued momentum for lead Rare Disease asset, Cortrophin Gel, with record new patient starts and cases initiated
  • Steady gains across our core therapeutic areas (rheumatology, neurology, nephrology) while moving into new areas of opportunity (pulmonology, ophthalmology, gout) in the ACTH market
  • Cortrophin momentum drove overall ACTH market expansion (15% year-over- year growth in 2023)
  • Continued to leverage exceptional new product launch execution, operational excellence, and US-based manufacturing footprint to reliably serve patients in Generics and Established Brands

Q4 Revenues

$132M

40% YoY

Q4 Diluted non-GAAP EPS(1)

$1.00

32% YoY

Q4 Cortrophin

Revenues

$42M

137% YoY

Q4 Adj. Non-GAAP EBITDA(1)

$30M

29% YoY

2023 Cash Flow from Operations

$119M

Q4 Generic, Established Brands, and Other Revenues

$90M

17% YoY

1. Adjusted non-GAAP EBITDA and Adjusted Non-GAAP Diluted EPS are non-GAAP financial measures. For reconciliation to the most directly comparable GAAP

© 2024 ANI Pharmaceuticals, Inc.

measure, please see Appendix A

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2024 Guidance

Metric

Full Year 2024

Growth vs Prior

($ millions except per share amounts)

Guidance

2023 Actuals

Year Actuals

Net Revenue (Total Company)

$520

- $542

$487

7 - 11%

Cortrophin Gel Net Revenue

$170

- $180

$112

52

- 61%

Adjusted Non-GAAP EBITDA (1)

$135

- $145

$134

1

- 8%

Adjusted Non-GAAP Diluted EPS (1)

$4.26

- $4.67

$4.71

(10) - (1)%

Adjusted Non-GAAP Diluted EPS guidance reflects a full year of shares outstanding from our May 2023 secondary equity raise.

© 2024 ANI Pharmaceuticals, Inc.

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

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ANI has consistently delivered high-growth since 2021; strong momentum across all business segments

Revenues ($ millions)

CAGR(3)

$520-$542(1)

Generics, Established

+35%(2)

$487

Brands & Others

18%

$316

$350-$362

$375

$216

Generics,

$275

Rare Disease

Est. Brands,

Royalties, and

$216

$170-$180

105%

Other

$112

Rare Disease

$42

$-

2021

2022

2023

2024E

Note: Figures presented may not total due to rounding.

© 2024 ANI Pharmaceuticals, Inc.

1. 2024 Guidance shared on fourth quarter earnings call (February 29, 2024)

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2. CAGR is calculated based on midpoint

3. Generics, Established Brands, Royalties and Others CAGR calculated 2021-2024; Rare Disease CAGR calculated using years 2022-2024

Revenue growth in 2024 driven by momentum across key growth drivers: Rare Disease and Generics

2023 Actuals ($

Full Year 2024

Guidance

Business Segment

millions)

($ millions)

Notes

Rare Disease

$112

$170 - $180

52% - 61% YoY growth

High single-digit/lowdouble-digit YoY

Generics

$269

organic growth

Established Brands,

2023 had full-year benefits from supply

$106

tailwinds; 2024 guidance includes only

Royalties & Other

tailwinds already seen in Q1

Total Generics, Established

$375

$350 - $362

Brands, Royalties & Other

Total Company

$487

$520 - $542

7% - 11% YoY growth

Note: Figures presented may not total due to rounding.

© 2024 ANI Pharmaceuticals, Inc.

7

Profitability driven by gross profit pull-through and leveraging of Rare Disease infrastructure

Adjusted Non-GAAP Gross Margin (1) ($ millions)

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

+35%(2)

$310 $329 - $335(1)

$183

2022

2023

2024E

58%

64%

62 - 63% (1)

+58%(2)

$134 $135 - $145(1)

$56

2022

2023

2024E

18%

27%

25 - 27%

Rare Disease contributed to profitability in 2023 in just second year of launch after 2022 investment to build Rare Disease infrastructure

Note: Figures presented may not total due to rounding.

© 2024 ANI Pharmaceuticals, Inc. 1.

2024 Guidance shared on fourth quarter earnings call (February 29, 2024)

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2.

CAGR is calculated based on midpoint of 2024 guidance range

Rare Disease: ANI's primary growth engine accelerating with lead asset Purified Cortrophin Gel as foundation

Continued momentum within specialties initially targeted at launch(1)

  • Record number of new patient starts and new cases initiated in Q4'23
  • New patient starts accelerated in Q4, and ANI posted the strongest sequential growth in net revenue to date
  • Strong growth across the 3 specialties targeted at launch: neurology, nephrology and rheumatology

Expansion into new areas

  • Launched new 1-mL vial size of Cortrophin Gel during Q4'23, the only approved ACTH therapy indicated for the treatment of acute gouty arthritis flares; received specific J-Code
  • Recently established pulmonology-focused sales team already driving Cortrophin Gel use; further expanding the pulmonology sales team in 2024
  • Expanding into ophthalmology in early 2024

Improved ACTH awareness and helped drive total market growth

  • ACTH market posted seven consecutive quarters of year-over-year growth(2)
  • Overall ACTH market grew 15%(2) in 2023, but number of patients on ACTH therapy today remains substantially lower than a few years ago, leaving room for significant added growth

Ability to leverage an established and proven Rare Disease platform

  • Experienced leadership team and sales force with a proven track record
  • Infrastructure and capabilities across medical affairs, patient support, specialty pharmacy distribution, and market access

Rare Disease Revenues

($ millions)

$41.7

$29.7

$24.3

$16.3

Q1'23

Q2'23

Q3'23

Q4'23

Full year 2024 guidance of

$170 - $180 million

1.

Purified Cortophin Gel was launched in January 2022

© 2024 ANI Pharmaceuticals, Inc.

2.

According to IQVIA data

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Investing in the Cortrophin Gel franchise to drive growth in 2024 and beyond

2023 Rare Disease

Est. 2024

Revenues

$112M

$170-$180M

+52 - 61%

Enter new

Support the

Expand scope

and scale of Rare

therapeutic areas

patient journey

Disease platform

• Given strong traction, add a

• Enhance the support and

• Use strong balance sheet

second geographical region

remove pain points for

and well-proven platform to

to pulmonology sales force

patients starting on ACTH

expand through M&A and in-

• Add a small targeted sales

and their healthcare

licensing of commercial or

providers

near-commercial products

force in ophthalmology

© 2024 ANI Pharmaceuticals, Inc.

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ANI Pharmaceuticals Inc. published this content on 12 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 March 2024 13:29:05 UTC.