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ANI Pharmaceuticals, Inc. 1 2023 ANI Pharmaceuticals, Inc. 1 Investor Presentation August 2023 2023 ANI Pharmaceuticals, Inc. 2 Disclaimer This presentation by ANI Pharmaceuticals, Inc ("ANI" or the "Company") contains f

Key Takeaway: ANI Pharmaceuticals, Inc. recently conducted an investor presentation highlighting its strong financial performance and strategic plans for growth. The company reported record revenues and Adjusted Non-GAAP EBITDA in the first and second quarters of 2023 and raised its full-year guidance for upcoming results. Key growth drivers include the momentum from its Purified Cortrophin Gel product, alongside efforts to leverage its rare disease platform. However, the company cautions investors about the inherent risks associated with forward-looking statements.

Market Sentiment Analysis

POSITIVE FACTORS

  • ANI Pharmaceuticals reported record quarterly revenues and Adjusted Non-GAAP EBITDA in Q1 and Q2 of 2023.
  • The company has raised its full-year guidance for 2023, indicating strong anticipated growth.
  • There is momentum in the launch of Purified Cortrophin Gel, with an increase in new patient starts and prescribers.

CONCERNS & RISKS

  • The presentation includes caution that forward-looking statements involve risks and uncertainties that could materially affect actual results.
  • Management indicates difficulty in estimating certain financial measures forward-looking due to variable adjustments.

Full Press Release Details

2023 ANI Pharmaceuticals, Inc. 1 2023 ANI Pharmaceuticals,
Inc. 1 Investor Presentation August 2023
2023 ANI Pharmaceuticals, Inc. 2 Disclaimer This presentation
by ANI Pharmaceuticals, Inc ("ANI" or the "Company") contains forward - looking statements, including informatio
n about management's view of the Company's future expectations, plans and prospects, as well as other forward - looking statements.
Any statements made in this presentation other than those of histori cal fact, about an action, event or development, are forward - looking
statements. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially
different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects
on the Company's future results. Information concer nin g these and other factors that may cause actual results to differ materially
from those anticipated in the forward - looking statements is contained in the "Risk Factors" section of the Company's
Annual Repo rt on Form 10 - K for the fiscal year ended December 31, 2022 and in the Company's other periodic reports and filings
with the Securities and Exchange Commission ("SEC"). The forward - looking statements included in this presentation are made
only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements and you should
not place undue relia nce on these forward - looking statements. We undertake no obligation to update any forward - looking statements
made in this presentation to reflect events or circumstances after the date of this presen tation or to reflect new information or the
occurrence of unanticipated events, except as required by law. Non - GAAP Financial Measures This presentation includes certain non -
GAAP financial measures, including Adjusted EBITDA and Adjusted Earnings Per Share (Adjus ted 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 t o 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 - cash stock - 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 inco
me (loss) is defined as net income (loss), plus the excess of fair value over cost of acquired inventory sold, non - cash stock - based
compensation expense, Novitium transaction expenses, non - cash interest exp ense, 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 im pact 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 wei ghted 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 a nd 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 ev ents
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 lim itations, 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. Ple ase 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 - looki ng 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 reconci lia tion, 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 adju stments will have on its reported results.
2023 ANI Pharmaceuticals, Inc. 3 ANI Pharmaceuticals
Is Well Positioned to Drive Sustainable Profitable Growth Scaling up Rare Disease business with Purified Cortrophin Gel (PCG) launch
momentum and adding assets that leverage our Rare Disease infrastructure Maximize value from Established Brands through innovative go
- to - market strategies Building a sustainable Biopharma company serving patients in need Strengthen generics business with enhanced
R&D capability focused on niche opportunities, cost - competitiveness and supply reliability Empowered and experienced talent retaining
core strengths and driving growth
2023 ANI Pharmaceuticals, Inc. 4 2022 Was a Landmark
Year for ANI, and the Momentum Has Continued During the First Half of 2023 (1) Adjusted non - GAAP EBITDA is a non - GAAP financial measure.
For reconciliation of Adjusted Non - GAAP EBITDA to the most directly co mparable GAAP measure, please see Appendix A. * CAGR is calculated
based on midpoint. Revenues ($ million) Adjusted Non - GAAP EBITDA (1) ($ million) 216 316 2022 2021 2023E* $425 - $445 +42% 51 56 2021
2022 2023E* $115 - $125 +53%
2023 ANI Pharmaceuticals, Inc. 5 ANI Achieved Record
Quarterly Revenues and Adjusted Non - GAAP EBITDA in Q1 2023, and Again in Q2 2023 Revenues ($ million) Adjusted Non - GAAP EBITDA (1)
($ million) $42 (1) Adjusted non - GAAP EBITDA is a non - GAAP financial measure. For reconciliation of Adjusted Non - GAAP EBITDA to
the most directl y comparable GAAP measure, please see Appendix A. $ 73.9 $ 116.5 Q2'22 Q2'23 $ 106.8 $ 116.5 Q1'23
Q2'23 $ 9.9 $ 34.1 Q2'22 Q2'23 $ 33.0 $ 34.1 Q1'23 Q2'23 Year - over - Year Sequential Year - over - Year
Sequential +58% + 9% +246% +3%
2023 ANI Pharmaceuticals, Inc. 6 Raised Full Year 2023
Guidance for Second Quarter in a Row (1) Adjusted non - GAAP EBITDA and Adjusted Non - GAAP Diluted EPS are non - GAAP financial measures.
For reconciliation to the most d irectly comparable GAAP measure, please see Appendix A. Metric ($ millions except per share amounts)
Revised Full Year 2023 Guidance Prior Full Year 2023 Guidance Growth vs Prior Year Actuals Net Revenue (total Company) $425 - $445 $385
- $410 34% - 41% Cortrophin Gel Net Revenue $90 - $100 $80 - $90 116% - 140% Adjusted Non - GAAP Gross Margin 63% to 64.8% 60% to 62.5%
4.7 pts to 6.5 pts Adjusted Non - GAAP EBITDA (1) $115 - $125 $97 - $107 106% - 124% Adjusted Non - GAAP Diluted EPS (1) $3.62 - $4.11
$2.99 - $3.45 166% - 202%
2023 ANI Pharmaceuticals, Inc. 7 Strong Launch Momentum
for Foundational Rare Disease Asset, Purified Cortrophin Gel Accelerating momentum with record number of new patient starts and new cases
initiated, as well as continued increase in new unique prescribers in Q2'23 Continued growth in repeat prescribers
ACTH market continues to show year - over - year growth for thirteen consecutive months # Built strong Rare Disease platform with medical
affairs, patient support, specialty pharmacy distribution, market access, and experienced sales force Rare Disease expected to be the
largest strategic driver of ANI's growth Well positioned to build upon the strength of our Rare Disease platform
Actively pursuing M&A and in - licensing opportunities * Initiated in 2023 # According to IQVIA data Continued growth across all
targeted specialties of neurology, nephrology and rheumatology; pulmonology* sales team gaining momentum Rare Disease Revenues ($ million)
$12.6 $17.6 $16.3 $24.3 Q3'22 Q4'22 Q1'23 Q2'23 Raised full - year guidance to $90 mn to $100 mn
2023 ANI Pharmaceuticals, Inc. 8 ACTH Class Has Shown
Year - over - Year Monthly Unit Growth For 13 consecutive months Source: IQVIA ACTH Units - Year - over - Year Change From June
2022 to June 2023, the ACTH category has demonstrated thirteen months of consecutive growth year - over - year -12.00% -10.00% -8.00%
-6.00% -4.00% -2.00% 0.00% 2.00% 4.00% 6.00% 8.00% 10.00% 12.00% 14.00% 16.00% 18.00% 20.00% 22.00% 24.00% 26.00% 28.00% Units Growth
2023 ANI Pharmaceuticals, Inc. 9 Strong R&D capabilities,
operational excellence and U.S. - based manufacturing footprint helped capture new business opportunities and drive growth in Generics
1 Superior pipeline and new product launch execution Increased R&D investment with focus on niche opportunities Filed
5 new ANDAs in 2023, including ANI's first two Para IV submissions Retained top 12 ranking in number of ANDA approvals*
2023 launches include Colestipol, Nitrofurantoin suspension & Estradiol Gel Driving cost - excellence Significant
focus on savings in procurement of raw materials and finished goods through innovative strategies Lean and entrepreneurial mentality
towards all spend Augmented our analytical and development facility in Chennai, India with over 60 skilled colleagues Ensuring
reliability of supply Strong compliance and audit history enhanced further by successful recent FDA audits across sites
Maintaining healthy inventory levels for finished goods and raw materials U.S. - based manufacturing sites (New Jersey &
Minnesota) Generics Revenues ($ million) Q2'23 revenues of $63.3M demonstrated 27 % growth over Q2'22 revenues of $49.9M
53.1 58.0 63.7 63.3 Q2'23 Q1'23 Q3'22 Q4'22 * Based on recent 6 months FDA approval activity; Source -
FDA Website, Internal Analysis
2023 ANI Pharmaceuticals, Inc. 10 U.S. Based Manufacturing
Footprint; Strong GMP Track Record, Including Successful Recent Audits at All Three Sites Manufacturing, packaging, warehouse
Schedule CII vault & CIII cage space Lab space - R&D/analytical testing Solutions, suspensions, topicals,
tablets, capsules, and powder for suspension DEA - licensed for Schedule II controlled substances Solid Dose ~2.5BN doses
Liquid Unit ~23MM doses Liquids ~20MM bottles Powder ~4MM bottles Four FDA inspections since 2013 Latest inspection
- November 2022 Results: VAI status Baudette, MN 130k sf Manufacturing, packaging, warehouse Low - humidity suite
for moisture - sensitive compounds Fully - contained high potency facility for hormone, steroid, and oncolytic products
DEA Schedule III capability Tablets ~2.5BN doses Capsules ~150MM doses Blisters ~ 45MM doses Six DEA inspections

Frequently Asked Questions

What are forward-looking statements?

Forward-looking statements are predictions about future events or expectations, differing from historical facts.

How does ANI define Adjusted EBITDA?

Adjusted EBITDA excludes various expenses like taxes, interest, and non-cash compensation, reflecting business performance.

What new guidance did ANI raise for 2023?

ANI raised its 2023 revenue guidance to $425-$445 million, indicating significant growth.

What is the focus of ANI's Rare Disease business?

The Rare Disease business aims to drive growth through the launch of Purified Cortrophin Gel and expanded prescriber engagement.

What is meant by non-GAAP financial measures?

Non-GAAP financial measures provide alternative performance indicators, excluding specific expenses to assess business health.

Last updated: Aug 30, 2023