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1. Company Snapshot

1.a. Company Description

ANI Pharmaceuticals, Inc., a biopharmaceutical company, develops, manufactures, and markets branded and generic prescription pharmaceuticals in the United States and Canada.It focuses on producing controlled substances, oncology products, hormones and steroids, injectables, and other formulations.The company manufactures oral solid dose products; semi-solids, liquids, and topicals; and potent products, as well as performs contract development and manufacturing of pharmaceutical products for other companies.


It markets its products through retail pharmacy chains, wholesalers, distributors and mail order pharmacies, and group purchasing organizations.The company was incorporated in 2001 and is headquartered in Baudette, Minnesota.

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1.b. Last Insights on ANIP

ANI Pharmaceuticals' recent performance faced challenges due to increasing costs associated with Cortrophin Gel, although Q3 earnings and revenues beat estimates. The company reported record quarterly net revenues of $227.8 million, up 53.6% year-over-year, driven by Purified Cortrophin Gel net revenues of $101.9 million, up 93.8%. Despite raising 2025 guidance, concerns may arise from growing expenses. ANI Pharmaceuticals received an average rating of "Moderate Buy" from analysts, with six issuing a buy rating (MarketBeat Ratings).

1.c. Company Highlights

2. ANI Pharmaceuticals' Strong Q3 2025 Earnings: A Closer Look

ANI Pharmaceuticals reported a robust third quarter 2025, with total company revenues growing 54% year-over-year to $227.8 million, driven by a 75% to 78% year-over-year growth in Cortrophin Gel revenue. Adjusted non-GAAP diluted earnings per share came in at $2.04, beating estimates of $1.74. The company's adjusted non-GAAP EBITDA was $59.6 million, up 69.8% compared to the prior year period. The strong financial performance was driven by the continued momentum across Rare Disease and Generics business units.

Publication Date: Nov -29

📋 Highlights
  • Record Revenue and EBITDA Growth:: Total revenue surged 54% YoY to $227.8M, adjusted EBITDA jumped 70% to $59.6M, and adjusted EPS rose 52% to $2.04.
  • Cortrophin Gel Dominates Rare Disease Growth:: Revenue from Cortrophin Gel hit $101.9M (Q3), up 75–78% YoY, driven by 15% usage in nephrology, neurology, and rheumatology gout.
  • 2025 Guidance Raised:: Net revenue now expected at $854–873M (39–42% YoY growth), with adjusted EBITDA projected at $221–228M (42–46% YoY growth).
  • ILUVIEN Reset and Cortrophin Long-Term Outlook:: ILUVIEN/YUTIQ revenue downgraded to $73–77M, but 2026+ growth anticipated; Cortrophin faces low generic risk due to complex development barriers.
  • Rare Disease Expansion Strategy:: 42% increase in ophthalmology sales volume, 30%+ Generics growth from new product launches, and focus on sarcoidosis/pulmonology expansion for Cortrophin.

Revenue Growth Drivers

The Rare Disease franchise was a key driver of growth, with revenues nearly doubling compared to the third quarter of 2024. Cortrophin Gel, the lead Rare Disease asset, saw significant growth driven by strong underlying demand, new patient starts, and new cases initiated. The company's expanded portfolio of sales force drove growth in nephrology, neurology, and rheumatology gout, representing 15% of Cortrophin Gel use. As Nikhil Lalwani, President and Chief Executive Officer, noted, "the Rare Disease team delivered another excellent quarter marked by continuing record demand for Cortrophin Gel."

Guidance and Outlook

Based on the strong performance, ANI Pharmaceuticals raised its top and bottom line 2025 financial guidance, expecting to grow net revenues 39% to 42% and 34% to 37% on an organic basis. The company expects Cortrophin Gel revenue to be $347 million to $352 million, a 75% to 78% year-over-year growth. The guidance increase reflects the company's confidence in its growth prospects, driven by the continued momentum in Rare Disease and Generics.

Valuation and Growth Prospects

With a P/S Ratio of 2.55 and EV/EBITDA of 21.26, the market is pricing in significant growth prospects for ANI Pharmaceuticals. Analysts estimate next year's revenue growth at 9.8%, which is lower than the current year's growth rate. The company's ability to drive growth in Cortrophin Gel and improve ILUVIEN performance will be key to meeting these expectations. With a strong track record of execution and a focus on Rare Disease, ANI Pharmaceuticals is well-positioned to deliver long-term value to stakeholders.

3. NewsRoom

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ANI Pharmaceuticals Announces Formation of “FutureVision Advisory Council” to Help Strategically Guide Ophthalmology and Retina Franchise

Dec -02

Source: globenewswire.com

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ANI Pharmaceuticals Announces Board Transition

Dec -01

Source: globenewswire.com

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ANIP vs. AMRX: Which Niche Drugmaker Is the Better Pick?

Nov -28

Source: zacks.com

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Advantage Alpha Capital Partners LP Cuts Stock Position in ANI Pharmaceuticals, Inc. $ANIP

Nov -28

Source: defenseworld.net

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ANI Pharmaceuticals to Present at the Piper Sandler 37th Annual Healthcare Conference

Nov -25

Source: globenewswire.com

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Here's How ANIP's Rare Disease Portfolio Is Driving Top-line Growth

Nov -21

Source: zacks.com

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ANI (ANIP) Loses 15% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

Nov -19

Source: zacks.com

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ANI Pharmaceuticals Stock Surges 53% YTD: Time to Buy or Sell?

Nov -14

Source: zacks.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (5.84%)

6. Segments

Generics, Established Brands, and Other

Expected Growth: 5.5%

{'Generics': 'Growth driven by increasing demand for affordable medications, expanded product offerings, and strategic partnerships.', 'Established Brands': 'Growth fueled by successful product launches, increased marketing efforts, and strong brand recognition.', 'Other': 'Growth attributed to diversification into new markets, expansion of contract manufacturing services, and strategic acquisitions.'}

Rare Disease

Expected Growth: 7.0%

ANI Pharmaceuticals' Rare Disease segment growth of 7.0% is driven by increasing demand for orphan drugs, expanded treatment options, and growing awareness of rare genetic disorders. Additionally, strategic partnerships, investments in R&D, and favorable regulatory environments contribute to the segment's growth.

7. Detailed Products

Generic Pharmaceuticals

ANI Pharmaceuticals, Inc. offers a range of generic pharmaceutical products, including tablets, capsules, and injectables, that are therapeutically equivalent to brand-name drugs.

Branded Pharmaceuticals

The company develops and commercializes branded pharmaceutical products, including Cortrophin Gel, which is used to treat certain inflammatory conditions.

Contract Manufacturing

ANI Pharmaceuticals, Inc. provides contract manufacturing services to other pharmaceutical companies, offering a range of services, including formulation development, manufacturing, and packaging.

Over-the-Counter (OTC) Products

The company offers a range of OTC products, including pain relievers, allergy medications, and digestive health products.

Nutritional Supplements

ANI Pharmaceuticals, Inc. develops and commercializes nutritional supplements, including vitamins, minerals, and other dietary supplements.

8. ANI Pharmaceuticals, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

ANI Pharmaceuticals, Inc. faces moderate threat from substitutes due to the presence of alternative pharmaceutical products in the market.

Bargaining Power Of Customers

ANI Pharmaceuticals, Inc. has a diverse customer base, which reduces the bargaining power of individual customers.

Bargaining Power Of Suppliers

ANI Pharmaceuticals, Inc. relies on a few key suppliers for raw materials, which gives them some bargaining power.

Threat Of New Entrants

The pharmaceutical industry has high barriers to entry, but new entrants can still pose a threat to ANI Pharmaceuticals, Inc. due to advancements in technology and changing regulatory environments.

Intensity Of Rivalry

The pharmaceutical industry is highly competitive, and ANI Pharmaceuticals, Inc. faces intense rivalry from established players and new entrants.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 41.78%
Debt Cost 7.97%
Equity Weight 58.22%
Equity Cost 7.97%
WACC 7.97%
Leverage 71.75%

11. Quality Control: ANI Pharmaceuticals, Inc. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Esperion Therapeutics

A-Score: 5.2/10

Value: 9.0

Growth: 5.9

Quality: 6.1

Yield: 0.0

Momentum: 9.0

Volatility: 1.0

1-Year Total Return ->

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Stock-Card
ANI Pharmaceuticals

A-Score: 5.0/10

Value: 4.3

Growth: 6.0

Quality: 4.4

Yield: 0.0

Momentum: 9.5

Volatility: 5.7

1-Year Total Return ->

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Phibro Animal Health

A-Score: 4.9/10

Value: 2.7

Growth: 5.2

Quality: 4.2

Yield: 4.0

Momentum: 9.5

Volatility: 4.0

1-Year Total Return ->

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OptiNose

A-Score: 4.4/10

Value: 7.4

Growth: 4.4

Quality: 5.1

Yield: 0.0

Momentum: 5.0

Volatility: 4.7

1-Year Total Return ->

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Aquestive Therapeutics

A-Score: 4.4/10

Value: 8.0

Growth: 3.7

Quality: 5.8

Yield: 0.0

Momentum: 7.5

Volatility: 1.7

1-Year Total Return ->

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Stock-Card
Evolus

A-Score: 4.1/10

Value: 9.2

Growth: 7.2

Quality: 6.2

Yield: 0.0

Momentum: 0.0

Volatility: 2.0

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

81.77$

Current Price

81.77$

Potential

-0.00%

Expected Cash-Flows