ANI Pharmaceuticals : Guggenheim Biotech Conference Presentation

Published: 2025-02-05 10:28:05 ET ANIP

Guggenheim SMID Cap Biotech Conference

February 5, 2025

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 (loss) income, excluding tax provision or benefit, interest expense, net, other expense, net, loss on extinguishment of debt, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, 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 below.

ANI is not providing a reconciliation for the forward-looking full year 2024 or 2025 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 on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, amortization of certain purchase price adjustments, 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.

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 below.

ANI is not providing a reconciliation for the forward-looking full year 2024 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.

ANI Pharmaceuticals: Rare Disease and Generics drive robust, profitable growth as we fulfill our purpose of Serving Patients, Improving Lives

Key Growth Drivers

Financial Strength

Rare Disease business with three growing and durable commercial assets: Purified Cortrophin Gel, ILUVIEN and YUTIQ. Portfolio expansion through M&A and in-licensing.

$594-602M 22-24%

2024 Year-over-year

Estimated net net revenue

revenue(1)growth(1)

Generics with

Established brands

$149-153M

$145M

2024 Adjusted

Cash(2)

enhanced R&D

with unique

capabilities driving

commercial capability,

Non-GAAP

new product launches;

high margins and

EBITDA(1),(3)

operational excellence

strong cash flow

generation

Based upon 2024 guidance issued on November 8, 2024.

As of September 30, 2024.

Adj. Non-GAAP EBITDA is a Non-GAAP financial measure.

Delivered superior 2024 performance and well-positioned to continue driving strong growth

Total Company Net Revenues ($ millions)(1)

Adjusted Non-GAAP EBITDA ($ millions)(1),(3)

~33% CAGR(2)

739-759

~50% CAGR(2)

182-192

594-602

149-153

487

134

316

2022

2023

2024E(1)

2025 E

2022

2023

2024E(1)

2025 E

2024 Highlights & Achievements

• Expect total 2024 Net Revenue, Adjusted non-GAAP EBITDA and adjusted non-GAAP diluted EPS at or above previously announced 2024 guidance

• Lead Rare Disease asset Cortrophin Gel achieved almost $200M of sales in the third year of launch

• Expanded Rare Disease franchise with the acquisition of Alimera

• Launched 17 new generic products and retained #2 ranking in Competitive Generic Therapy (CGT) approvals

Based on 2024 financial guidance as issued on November 8, 2024.

CAGR calculated using 2022-2025E utilizing mid-point of full year 2025 guidance.

Adjusted Non-GAAP EBITDA is a Non-GAAP financial measure.

Momentum continued in 2024 with ANI delivering record results in Q4

Highlights

4Q Total

4Q Rare Disease

4Q Cortrophin

Revenues(1)

Revenues (2)

Gel Revenues(2)

$170-178M

$86-87M

$59-60M

32% YoY

107% YoY

42% YoY

4Q ILUVIEN &

4Q Adj. Non-

YUTIQ Revenues(2)

GAAP EBITDA(1,3)

~$27M

$43-47M

49% YoY

Based on 2024 financial guidance as issued on November 8, 2024.

Based upon preliminary, unaudited Q4 2024 results.

Adjusted non-GAAP EBITDA and Adjusted Diluted non-GAAP EPS are non-GAAP financial measures.

Preliminary 2025 Outlook

Metric

Full Year 2025

Mid-Point

2025 Growth vs

($ millions)

Guidance

2024

2024 Guidance

Guidance(1)

Midpoint

Net Revenue (Total Company)

$739 - $759

$598

24 - 27%

Adjusted Non-GAAP EBITDA (2)

$182 - $192

$151

21 - 27%

Based upon 2024 financial guidance as issued on November 8, 2024.

Adjusted Non-GAAP EBITDA is a Non-GAAP financial measure.

Rare Disease well positioned to continue driving strong growth

Rare Disease Net Revenues ($ millions)(1)

228-229

30-31

ILUVIEN & YUTIQ

+133% (1)

112

Cortrophin Gel

198

112

2022

2023

2024E (2)

2022-24 CAGR is based on the midpoint of full-year 2024 preliminary, unaudited results

Based on full-year 2024 preliminary, unaudited results

ANI Rare Disease markets three therapeutics with growth and durability

FDA-approved ACTH treatment option

Indicated for the treatment of diabetic

Indicated for the treatment of chronic

with 22 indications for patients

macular edema (DME) in patients who

non-infectious uveitis affecting the

suffering with specific chronic

have been previously treated with a

posterior segment of the eye.

autoimmune and inflammatory

course of corticosteroids and did not

U.S.

conditions, including multiple sclerosis,

have a clinically significant rise in

rheumatoid arthritis, excess urinary

intraocular pressure.

Indications

protein due to nephrotic syndrome,

acute gouty arthritis flares, and acute

and chronic allergic and inflammatory

processes involving the eye and its

adnexa

Ex-US

N/A

For DME and NIU-PS in the

N/A

Indications

Middle East, and 17 European countries

US Approval

November 2021

September 2014

October 2018

sNDA

Date

Added via acquisition of Alimera in September 2024

Rare Disease portfolio focuses on patients not well-served by other therapies

Select Indications

Rare disease*

Underserved

patients;

high prevalence

disease

•

Idiopathic Nephrotic Syndrome

•

Keratitis

•

Lupus Nephritis

•

Chronic Non-Infectious

•

Systemic Dermatomyositis

Uveitis Posterior Segment

•

Sarcoidosis

•

Rheumatoid Arthritis

•

Ankylosing Spondylitis

•

Multiple Sclerosis

•

Acute Gouty Arthritis

•

Systemic Lupus Erythematosus

•

Diabetic Macular Edema

•

Psoriatic Arthritis

•

Non-Infectious Uveitis

* Based on US FDAconsidered definition of rare disease - disorders affecting <200 000 persons, translating to a prevalence of 58.5 per 100 000 at current time

Disclaimer

ANI Pharmaceuticals Inc. published this content on February 05, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on February 05, 2025 at 15:27:07.659.