ANI Pharmaceuticals, Inc.
- Open
- 73.54
- Day high
- 74.99
- Day low
- 72.77
- Prev close
- 73.25
- Volume
- 109K
- Mkt cap
- $1.7B
- P/E (TTM)
- 15.3
- EPS (TTM)
- $4.83
- P/B
- 2.8
- P/S
- 1.7
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$1.9M over the last 3 months (0 open-market buys, 10 sales)
- 🏛Institutions accumulating (13F)
ANI Pharmaceuticals, Inc. (ANIP) is a Healthcare company listed on NASDAQ. The stock is down 23% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 10 sales (SEC Form 4).
ANI Pharmaceuticals, Inc. (ANIP) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 2 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
ANIP earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 7, 2026 | $2.04 | $2.21 | +8.3% | $266M | +2.3% |
| May 8, 2026 | $1.28 | $2.05 | +60.2% | $237M | +14.4% |
| Nov 7, 2025 | $1.74 | $2.04 | +17.2% | $228M | -1.9% |
| Aug 8, 2025 | $1.38 | $1.80 | +30.4% | $211M | +1.2% |
| May 9, 2025 | $1.37 | $1.70 | +24.1% | $197M | +4.4% |
| Feb 28, 2025 | $1.41 | $1.63 | +15.6% | $191M | +12.1% |
| Nov 8, 2024 | $1.09 | $1.34 | +22.9% | $148M | -15.3% |
| May 10, 2024 | $0.98 | $1.21 | +23.5% | $137M | +9.5% |
| Feb 29, 2024 | $0.80 | $1.00 | +25.0% | $132M | +7.7% |
| Mar 9, 2023 | $0.68 | $0.76 | +11.8% | $94M | +9.4% |
| Mar 15, 2022 | $0.82 | $0.54 | -34.0% | $61M | +7.8% |
| Nov 1, 2021 | $0.71 | $1.01 | +41.7% | $52M | +4.0% |
ANIP insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Aug 27, 2026 | Gosebruch Henry Odirector | Grant | 6,662 | — |
| Aug 26, 2026 | Lalwani Nikhildirector, officer: PRESIDENT & CEO | Sell | 5,400 | $74.30 |
| Aug 13, 2026 | Cook Meredithofficer: SR. VP, GENERAL COUNSEL & SEC. | Sell | 500 | $75.48 |
| Aug 11, 2026 | Gutwerg Oriofficer: SVP, GENERICS | Sell | 3,162 | $77.00 |
| Jul 30, 2026 | CAREY STEPHEN P.officer: SVP & CFO | Sell | 2,850 | $81.36 |
| Jul 21, 2026 | Cook Meredithofficer: SR. VP, GENERAL COUNSEL & SEC. | Tax | 2,466 | $79.20 |
| Jul 14, 2026 | Cook Meredithofficer: SR. VP, GENERAL COUNSEL & SEC. | Sell | 500 | $81.84 |
| Jul 6, 2026 | CAREY STEPHEN P.officer: SVP & CFO | Sell | 3,313 | $86.00 |
| Jul 6, 2026 | CAREY STEPHEN P.officer: SVP & CFO | Option | 3,313 | $49.51 |
| Jun 30, 2026 | CAREY STEPHEN P.officer: SVP & CFO | Sell | 2,850 | $84.12 |
| Jun 15, 2026 | Cook Meredithofficer: SR. VP, GENERAL COUNSEL & SEC. | Sell | 500 | $82.03 |
| Jun 10, 2026 | HAUGHEY THOMASdirector | Grant | 4,357 | — |
| Jun 10, 2026 | HAUGHEY THOMASdirector | Sell | 2,000 | $80.88 |
| Jun 10, 2026 | Pera Antonio Rdirector | Grant | 4,357 | — |
| Jun 10, 2026 | TANNENBAUM RENEE Pdirector | Grant | 4,357 | — |
Source: ANIP SEC Form 4 filings, latest Aug 27, 2026. For informational purposes only — not investment advice.
See the full ANIP insider & 13F page →ANI Pharmaceuticals, Inc. company profile
Overview
ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) is a biopharmaceutical company founded in 2001 and headquartered in Baudette, Minnesota. The company has evolved from a traditional generic drug manufacturer into a specialized pharmaceutical company with a growing focus on rare disease treatments. ANI went public in 2000 and has undergone significant transformation over the past few years, particularly through strategic acquisitions and the successful launch of its rare disease franchise centered around Cortrophin Gel. Today, the company operates as a diversified pharmaceutical manufacturer serving both the generic and specialty drug markets across the United States and Canada.
Business
ANI Pharmaceuticals operates in the pharmaceutical manufacturing industry, developing, manufacturing, and marketing both branded specialty pharmaceuticals and generic prescription drugs. The company has strategically positioned itself across three main business segments that reflect the modern pharmaceutical landscape. The Rare Disease and Brands segment represents ANI's highest-growth and most profitable division, accounting for approximately 50% of total revenues. The flagship product is Cortrophin Gel, a purified adrenocorticotropic hormone (ACTH) therapy used to treat various inflammatory and autoimmune conditions including multiple sclerosis relapses, rheumatoid arthritis, and acute gouty arthritis. ACTH is a hormone that stimulates the adrenal glands to produce cortisol, providing anti-inflammatory effects for patients with these conditions. This segment also includes two ophthalmology products acquired in 2024: ILUVIEN and YUTIQ, which are sustained-release implants used to treat diabetic macular edema and posterior uveitis respectively. The Generics segment contributes approximately 40% of revenues and focuses on manufacturing generic versions of branded pharmaceuticals after their patents expire. This includes controlled substances, oncology products, hormones, steroids, and injectable medications. Generic drugs provide the same therapeutic benefits as brand-name drugs but at significantly lower costs, making them essential for healthcare cost management. The Established Brands segment represents about 10% of revenues and consists of older branded products that have lost patent exclusivity but maintain some market presence. These products typically experience declining revenues over time as generic competition increases. ANI specializes in complex drug formulations including oral solid dose products, semi-solids, liquids, topicals, and potent compounds that require specialized manufacturing capabilities. The company also provides contract development and manufacturing services for other pharmaceutical companies, leveraging its manufacturing expertise and regulatory compliance capabilities.
Revenue model
ANI Pharmaceuticals generates revenue through direct product sales to a diverse customer base including retail pharmacy chains, wholesalers, distributors, mail-order pharmacies, and group purchasing organizations. The company's business model combines high-margin specialty pharmaceuticals with steady-volume generic drug sales. The Rare Disease and Brands segment operates on a premium pricing model due to limited competition and specialized patient populations. Cortrophin Gel, as the only FDA-approved purified ACTH therapy, commands significant pricing power with gross margins typically exceeding 80%. Revenue growth in this segment depends on expanding the prescriber base across multiple medical specialties and increasing patient adoption. The ophthalmology products ILUVIEN and YUTIQ also benefit from specialized positioning in niche therapeutic areas. The Generics segment operates on a volume-based model with lower margins but more predictable demand. Revenue depends on successful FDA approvals, manufacturing efficiency, and competitive positioning. ANI's focus on complex generics and controlled substances provides some protection from intense price competition that affects simpler generic drugs. Several factors can positively impact margins: successful new product launches, manufacturing efficiency improvements, favorable product mix shifts toward higher-margin rare disease products, and market share gains in existing products. The company's U.S.-based manufacturing provides supply chain advantages and potential protection from international trade disruptions. Margin pressures can arise from increased competition in generic markets, regulatory compliance costs, raw material price inflation, and payer pressure on drug pricing. The rare disease segment faces potential challenges from Medicare access restrictions and evolving reimbursement policies. Manufacturing disruptions or quality issues could significantly impact both revenue and profitability given the company's concentrated production facilities.
Competitive moat
ANI Pharmaceuticals possesses a moderate but growing competitive moat primarily centered around its rare disease franchise and specialized manufacturing capabilities. The company's strongest moat exists in its Cortrophin Gel franchise, where it holds the distinction of being the only FDA-approved purified ACTH therapy available in the United States. This regulatory exclusivity, combined with the complex manufacturing process and specialized patient population, creates significant barriers to entry for potential competitors. The company's manufacturing expertise in complex drug formulations provides additional competitive advantages. ANI specializes in controlled substances, potent compounds, and sterile injectables that require sophisticated manufacturing capabilities and regulatory compliance. These technical barriers, combined with the company's established relationships with regulatory agencies, create meaningful switching costs for customers and entry barriers for competitors. However, ANI's moat faces several potential challenges. In the generics business, the company operates in a highly competitive environment where pricing pressure is constant and barriers to entry are relatively low once patents expire. The rare disease segment, while currently protected, could face competition from biosimilar ACTH products or alternative therapeutic approaches as the market grows and attracts more attention from larger pharmaceutical companies. The company's scale limitations compared to major pharmaceutical companies represent a vulnerability. ANI lacks the resources for extensive research and development or large-scale clinical trials that could expand its rare disease portfolio organically. The company's growth strategy relies heavily on acquisitions and in-licensing deals, which may become more expensive as the rare disease market attracts increased interest from well-capitalized competitors. Geographic concentration in North American markets also limits the company's moat compared to global pharmaceutical companies. While this focus provides operational advantages, it also creates dependence on U.S. healthcare policies and reimbursement decisions that could significantly impact the business.
Risks & safety
ANI Pharmaceuticals demonstrates a moderate margin of safety with solid financial fundamentals but some leverage concerns following recent acquisitions. • Liquidity position: Strong with $149.8 million in cash and short-term investments as of Q1 2025, providing substantial operating flexibility • Current ratio: Healthy at 2.66x, indicating good short-term liquidity management • Debt levels: Elevated debt-to-equity ratio of 0.76x reflects recent acquisition financing, though manageable given cash flow generation • Cash flow generation: Positive operating cash flow of $35.0 million in Q1 2025 and $64.0 million for full year 2024, demonstrating underlying business strength • Valuation metrics: P/E ratio of 20.9x appears reasonable for a growing specialty pharmaceutical company; EV/EBITDA of 7.3x suggests moderate valuation • Profitability trends: EBITDA margins improving with rare disease segment growth, though net income volatility reflects acquisition-related expenses • Revenue concentration risk: Heavy dependence on Cortrophin Gel success creates some business concentration risk, though diversification efforts are underway through acquisitions
Recent development
ANI Pharmaceuticals has undergone significant strategic transformation over the past few years, evolving from a primarily generic drug manufacturer into a specialized pharmaceutical company with a strong rare disease focus. The most significant development has been the successful launch and scaling of Cortrophin Gel, which grew from $41.7 million in its first year (2022) to $194 million in 2024, representing the company's transition into high-margin specialty pharmaceuticals. In September 2024, ANI completed the acquisition of Alimera Sciences, adding two ophthalmology products (ILUVIEN and YUTIQ) and a 45-person specialized sales force. This $380 million acquisition significantly expanded the rare disease portfolio and is expected to generate $35-38 million in adjusted EBITDA for 2025. The integration has enabled cross-selling opportunities across ANI's three commercial rare disease assets. The company has made substantial investments in product development and market expansion for Cortrophin Gel. Key initiatives include developing a pre-filled syringe formulation (FDA submission completed in late 2024), expanding into new therapeutic areas including gout treatment, and growing the prescriber base across multiple medical specialties. The product has shown consistent growth with 40% of prescribers being new to ACTH therapy. ANI has also strengthened its manufacturing capabilities through facility expansions and operational improvements. The company completed capacity expansion at its New Jersey manufacturing site and has maintained its position as a top-ranked generic drug developer with 17 new product approvals in 2024. The focus on U.S.-based manufacturing provides supply chain advantages and positions the company well for potential trade policy changes. Looking forward, ANI is actively pursuing additional business development opportunities in the rare disease space, with management indicating willingness to increase leverage up to 3x for the right acquisitions. The company is also conducting clinical trials for its ophthalmology products, with NEW DAY study results expected in Q2 2025 and SYNCHRONICITY study completion projected for late 2025.
ANIP company profile · for informational purposes only — not investment advice.
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