olivLaw · US equity research
ANI Pharmaceuticals, Inc. ANIP
Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)
ANI Pharmaceuticals is a diversified biopharmaceutical company operating across Rare Disease, Generics and Brands, with Cortrophin Gel and ILUVIEN at the centre of its growth. It is now expanding its sales force for acute gouty arthritis flares as its Rare Disease business scales. Net revenues reached 883.4 million USD in fiscal 2025 and 266.0 million USD in Q2 2026.
At the close of 04 Nov 2026, ANI Pharmaceuticals, Inc. (ANIP) stock was 71.65 USD (−0.87% on the day), with market capitalisation 1.7 bn USD, P/E 15.2 on diluted EPS of 4.70 USD over the last 12 months, dividend yield 0.02%, beta 0.52, 52-week range 70.16–92.62 USD. Latest reported quarter (Q2 2026): revenue of 266.0 m USD (+25.9% YoY), net income of 24.7 m USD (+189.1% YoY), diluted EPS 1.05 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 46.8
- neutral
- Bollinger (20, 2)
- 70.26 – 74.15
- in the lower half of the band · %B 0.36 · band width 5.4%
- SMA 50 / 200
- 72.74 / 77.45
- downtrend (price < SMA50 < SMA200)
- MACD (12, 26, 9)
- -0.39 / -0.40
- MACD above signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −1.3% | −1.1% | −0.2 pp | — |
| 3 months | −10.3% | −0.5% | −9.9 pp | — |
| 6 months | −14.8% | +4.4% | −19.2 pp | — |
| Year to date | −9.2% | +12.3% | −21.6 pp | — |
| 1 year | −24.2% | +13.5% | −37.7 pp | +19.6% |
| 3 years | +9.5% | +76.4% | −66.9 pp | +33.9% |
| 5 years | +43.2% | +63.7% | −20.4 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 148.3 m | 190.6 m | 197.1 m | 211.4 m | 227.8 m | 247.1 m | 237.5 m | 266.0 m |
| Cost of revenue | 63.1 m | 80.3 m | 73.0 m | 74.6 m | 93.4 m | 100.3 m | 93.6 m | 100.2 m |
| Research & development | 10.1 m | 16.6 m | 10.6 m | 16.5 m | 12.3 m | 12.3 m | 10.6 m | 14.7 m |
| SG&A | 79.1 m | 69.7 m | 76.5 m | 81.8 m | 76.7 m | 82.8 m | 73.7 m | 91.7 m |
| Operating income | -20.5 m | -4.4 m | 26.2 m | 13.9 m | 36.2 m | 34.8 m | 38.9 m | 40.5 m |
| Depreciation & amortisation | 15.7 m | 22.6 m | 22.9 m | 23.3 m | 22.6 m | 22.6 m | 20.9 m | 19.6 m |
| Interest expense | 6.7 m | 8.8 m | 8.1 m | 8.2 m | 8.3 m | 8.0 m | 7.6 m | 7.5 m |
| Pre-tax income | -31.5 m | -13.8 m | 20.0 m | 10.5 m | 33.8 m | 31.5 m | 40.2 m | 37.1 m |
| Income tax | -7.3 m | -3.5 m | 4.3 m | 2.0 m | 7.2 m | 4.0 m | 10.7 m | 12.4 m |
| Net income | -24.2 m | -10.3 m | 15.7 m | 8.5 m | 26.6 m | 27.5 m | 29.5 m | 24.7 m |
| Diluted EPS | -1.27 | -0.53 ≈ | 0.69 | 0.36 | 1.13 | 1.24 ≈ | 1.28 | 1.05 |
| Operating cash flow | 12.5 m ≈ | 15.9 m | 35.0 m | 75.8 m ≈ | 44.1 m ≈ | 30.4 m | 58.4 m | 56.7 m ≈ |
| Capex | 4.8 m ≈ | 2.4 m | 2.5 m | 4.0 m ≈ | 6.1 m ≈ | 1.2 m | 6.1 m | 3.1 m ≈ |
| Dividends paid | 406.0 k ≈ | 406.0 k | 406.0 k | 407.0 k ≈ | 344.0 k ≈ | 0 | 0 | 0 ≈ |
| Share repurchases | 680.0 k ≈ | 318.0 k | 10.0 m | 551.0 k ≈ | 1.0 m ≈ | 611.0 k | 19.8 m | 813.0 k ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Today's P/E sits at the 0 percentile of its own 18-quarter history (min 17.6, median 59.0, max 5,654.0; quarters with earnings only).
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 201.6 m | 206.5 m | 208.5 m | 216.1 m | 316.4 m | 486.8 m | 614.4 m | 883.4 m |
| Revenue YoY | +14.0% | +2.5% | +0.9% | +3.7% | +46.4% | +53.9% | +26.2% | +43.8% |
| Net income | 15.5 m | 6.1 m | -22.5 m | -42.6 m | -47.9 m | 18.8 m | -18.5 m | 78.3 m |
| Net income YoY | unavailable | −60.7% | −470.0% | unavailable | unavailable | unavailable | −198.6% | unavailable |
| Diluted EPS | 1.30 | 0.50 | -1.88 | -3.40 | -3.05 | 0.85 | -1.04 | 3.32 |
| Diluted EPS YoY | unavailable | −61.5% | −476.0% | unavailable | unavailable | unavailable | −222.4% | unavailable |
| net % | 7.7% | 3.0% | -10.8% | -19.7% | -15.1% | 3.9% | -3.0% | 8.9% |
| Free cash flow | 61.3 m | 39.0 m | 9.1 m | 765.0 k | -40.1 m | 110.1 m | 47.8 m | 171.4 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 285.6 m USD
- Financial debt
- 309.1 m USD
- Net debt
- 23.5 m USD
- Equity
- 540.7 m USD
- Total assets
- 1.4 bn USD
- Debt / equity
- 0.57x
- Current ratio
- 2.71x
- ROE
- 16.6%
- ROA
- 5.7%
- FCF margin
- 19.4%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 208.5 m | 216.1 m | 316.4 m | 486.8 m | 614.4 m | 883.4 m | SEC (XBRL)· 27 Feb 2026verified |
| Cost of revenue | 87.2 m | 100.6 m | 138.8 m | 181.5 m | 250.2 m | 341.3 m | SEC (XBRL)· 27 Feb 2026verified |
| Gross profit | 121.3 m ≈ | 115.5 m ≈ | 177.6 m ≈ | 305.3 m ≈ | 364.2 m ≈ | 542.1 m ≈ | SEC (XBRL)· 27 Feb 2026derived |
| Research & development | 16.0 m | 11.4 m | 22.3 m | 34.3 m | 44.6 m | 51.7 m | SEC (XBRL)· 27 Feb 2026verified |
| SG&A | 65.0 m | 84.3 m | 124.0 m | 161.7 m | 249.6 m | 317.7 m | SEC (XBRL)· 27 Feb 2026verified |
| Operating income | -16.0 m | -39.8 m | -35.3 m | 47.0 m | 584.0 k | 111.1 m | SEC (XBRL)· 27 Feb 2026verified |
| Depreciation & amortisation | 44.6 m | 47.3 m | 57.0 m | 59.8 m | 67.7 m | 91.4 m | SEC (XBRL)· 27 Feb 2026verified |
| EBITDA | 28.6 m ≈ | 7.5 m ≈ | 21.7 m ≈ | 106.8 m ≈ | 68.3 m ≈ | 202.5 m ≈ | SEC (XBRL)· 27 Feb 2026derived |
| Interest expense | 9.5 m | 11.9 m | 28.5 m | 35.6 m | 33.6 m | 32.6 m | SEC (XBRL)· 27 Feb 2026verified |
| Pre-tax income | -26.0 m | -56.1 m | -62.7 m | 19.9 m | -22.2 m | 95.8 m | SEC (XBRL)· 27 Feb 2026verified |
| Income tax | -3.4 m | -13.5 m | -14.8 m | 1.1 m | -3.7 m | 17.5 m | SEC (XBRL)· 27 Feb 2026verified |
| Net income | -22.5 m | -42.6 m | -47.9 m | 18.8 m | -18.5 m | 78.3 m | SEC (XBRL)· 27 Feb 2026verified |
| Diluted EPS | -1.88 | -3.40 | -3.05 | 0.85 | -1.04 | 3.32 | SEC (XBRL)· 27 Feb 2026verified |
| Weighted average diluted shares | 12.0 m | 12.6 m | 16.3 m | 18.2 m | 19.3 m | 21.2 m | SEC (XBRL)· 27 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Revenue − Cost of revenue; Operating income + Depreciation & amortisation.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 7.9 m | 100.3 m | 48.2 m | 221.1 m | 144.9 m | 285.6 m | SEC (XBRL)· 27 Feb 2026verified |
| Receivables | 95.8 m | 128.5 m | 165.4 m | 162.1 m | 221.7 m | 281.1 m | SEC (XBRL)· 27 Feb 2026verified |
| Inventories | 60.8 m | 81.7 m | 105.4 m | 111.2 m | 136.8 m | 143.1 m | SEC (XBRL)· 27 Feb 2026verified |
| Current assets | 170.3 m | 321.8 m | 344.3 m | 519.8 m | 528.5 m | 753.1 m | SEC (XBRL)· 27 Feb 2026verified |
| Property, plant & equipment, net | 41.3 m | 52.7 m | 43.2 m | 44.6 m | 56.9 m | 62.5 m | SEC (XBRL)· 27 Feb 2026verified |
| Goodwill | 3.6 m | 27.9 m | 28.2 m | 28.2 m | 60.0 m | 62.5 m | SEC (XBRL)· 27 Feb 2026verified |
| Intangibles (excl. goodwill) | 188.5 m | 294.1 m | 251.6 m | 209.0 m | 541.8 m | 479.5 m | SEC (XBRL)· 27 Feb 2026verified |
| Total assets | 461.2 m | 771.6 m | 760.1 m | 904.4 m | 1.3 bn | 1.4 bn | SEC (XBRL)· 27 Feb 2026verified |
| Accounts payable | 11.3 m | 23.0 m | 29.3 m | 36.7 m | 45.7 m | 62.6 m | SEC (XBRL)· 27 Feb 2026verified |
| Short-term debt | 13.2 m | 850.0 k | 850.0 k | 850.0 k | 9.2 m | 17.3 m | SEC (XBRL)· 27 Feb 2026verified |
| Long-term debt | 172.4 m | 286.5 m | 285.7 m | 284.8 m | 309.1 m | 291.8 m | SEC (XBRL)· 27 Feb 2026verified |
| Current liabilities | 78.6 m | 87.5 m | 99.4 m | 145.5 m | 194.5 m | 278.1 m | SEC (XBRL)· 27 Feb 2026verified |
| Total liabilities | 265.5 m | 412.9 m | 421.5 m | 446.8 m | 855.9 m | 899.7 m | SEC (XBRL)· 27 Feb 2026verified |
| Equity | 195.7 m † | 333.9 m † | 313.7 m † | 432.7 m † | 403.7 m † | 540.7 m † | SEC (XBRL)· 27 Feb 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | 15.3 m | 3.3 m | -31.2 m | 119.0 m | 64.0 m | 185.2 m | SEC (XBRL)· 27 Feb 2026verified |
| Capex | 6.1 m | 2.6 m | 8.9 m | 8.9 m | 16.2 m | 13.8 m | SEC (XBRL)· 27 Feb 2026verified |
| Free cash flow | 9.1 m ≈ | 765.0 k ≈ | -40.1 m ≈ | 110.1 m ≈ | 47.8 m ≈ | 171.4 m ≈ | SEC (XBRL)· 27 Feb 2026derived |
| Investing cash flow | -68.3 m | -105.5 m | -15.7 m | -18.5 m | -404.7 m | -34.3 m | SEC (XBRL)· 27 Feb 2026verified |
| Financing cash flow | -1.4 m | 194.6 m | -5.1 m | 67.4 m | 264.9 m | -9.9 m | SEC (XBRL)· 27 Feb 2026verified |
| Dividends paid | 0 | 190.0 k | 1.6 m | 1.6 m | 1.6 m | 1.2 m | SEC (XBRL)· 27 Feb 2026verified |
| Share repurchases | 1.5 m | 890.0 k | 2.0 m | 5.0 m | 11.0 m | 12.2 m | SEC (XBRL)· 27 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
Score: 79 / 100
A scoring methodology on indicators and valuation, not investment advice.
score >= 65 · margin_of_safety >= 0.15 · agreement in ['high', 'medium']
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 1.7 bn USD
Key indicators
Coverage and freshness
Score by group
- Balance sheet64
- Growth100
- Quality82
- Returns51
- Valuation92
Estimated value range
The combined range = the median of the valid methods' low, central and high values; it is not a probability interval and does not cover every result. Envelope of all methods: 82.78 – 235.66 USD.
Valuation assumptions are editorial choices, not measured; beta is not measured.
Method ranges (USD per share)
— — Mid · ▏ Price
Valuation methods
- DCF (discounted cash flow)147.53 – 235.66 (Mid 180.82)WACC 8.6% · starting FCFF 196.8 m USD · terminal value share of EV 76%The WACC × g sensitivity gives the method's bounds; these are not probabilities.Reverse DCF: starting growth implied by the price (fading linearly to terminal growth, everything else fixed): -23.8%
- Peers: EV/EBITDA125.06 – 222.45 (Mid 161.35)4 companies used · median multiple 16.4x · quartiles 12.7x – 22.8xPBYI, TEVA, VRTX, VTRS
- Peers: P/E82.78 – 204.06 (Mid 107.92)15 companies used · median multiple 23.0x · quartiles 17.6x – 43.4xABBV, ABT, ALNY, BMY, JNJ, LAB, LLY, PBYI, PFE, REGN, RPRX, TGTX, UTHR, VRTX, ZTS
- Dividend discount (DDM)unavailable · input data missing
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Attractive profile · Score 79/100
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | 21.3% | 83 (vs peers) | 11% |
| Net margin · Quality | 11.1% | 62 (vs peers) | 7% |
| FCF conversion · Quality | 159.7% | 100 (on a fixed band) | 7% |
| Revenue CAGR 3Y · Growth | 40.8% | 100 (on a fixed band) | 9% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | -0.2x | 57 (vs peers) | 11% |
| Interest coverage · Balance sheet | 4.8x | 51 (on a fixed band) | 7% |
| Current ratio · Balance sheet | 2.9x | 100 (on a fixed band) | 5% |
| P/E (TTM) · Valuation | 15.2x | 78 (vs peers) | 11% |
| EV/EBITDA · Valuation | 7.2x | 100 (vs peers) | 11% |
| FCF yield · Valuation | 9.9% | 100 (on a fixed band) | 9% |
| Shareholder yield (distributions) · Returns | 1.3% | 18 (on a fixed band) | 7% |
| Payout ratio (FCF) · Returns | 0.2% | 100 (on a fixed band) | 5% |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet64/100 · 3/3 factors with a value
- Growth· partial100/100 · 1/2 factors with a value
- Quality82/100 · 3/3 factors with a value
- Returns51/100 · 2/2 factors with a value
- Valuation92/100 · 3/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
ANI PHARMACEUTICALS, INC (ANIP). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 883.4 m USD in 2025; YoY growth 43.8%; net margin 11.1%; ROE 21.0%; net debt/EBITDA -0.2x.
The estimated value range is 125.06–222.45 USD per share (median of 3 methods, agreement: medium); assumptions are illustrative. Against the central value of 161.35 USD, the price of 71.65 USD leaves a potential of 125.2% (value / price − 1) and a margin of safety of 55.6% (1 − price / value). The range is the median of the methods' low, central and high values, not a probability interval.
olivLaw score 79/100, methodological classification: attractive profile (score, margin of safety and method agreement together; not a judgement of the right price). Groups assessed only in part: growth. Not investment advice.
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- ROIC: 21.3%
- FCF conversion: 159.7%
- Revenue CAGR 3Y: 40.8%
- Current ratio: 2.9x
- P/E (TTM): 15.2x
- EV/EBITDA: 7.2x
- FCF yield: 9.9%
- Payout ratio (FCF): 0.2%
- The price is below the estimated value range
What contradicts it
- Shareholder yield (distributions): 1.3%
Not assessed (insufficient data or a ratio without meaning): EPS CAGR 3Y.
Versus the vertical median
Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| LLYEli Lilly And Company | 1,334.0 bn | 46.0 | 86.1% | 31.9% | +44.7% | +32% / +140% |
| JNJJohnson & Johnson | 665.2 bn | 41.9 | 20.0% | 16.2% | +6.0% | +34% / +79% |
| ONCBeone Medicines Ltd. | 558.4 bn | 869.9 | 14.7% | 10.7% | +40.2% | +11% / +102% |
| ABBVAbbVie Inc. | 521.1 bn | 50.7 | — | 15.7% | +8.6% | +29% / +107% |
| MRKMerck & Co., Inc. | 370.7 bn | 154.7 | 5.1% | 3.6% | +1.3% | +43% / +47% |
| ABTAbbott Laboratories | 200.1 bn | 43.0 | 9.2% | 9.7% | +5.7% | −10% / +11% |
| PFEPfizer Inc | 175.5 bn | 43.9 | 4.4% | 6.3% | −1.6% | +20% / +1% |
| VRTXVertex Pharmaceuticals Inc | 139.2 bn | 35.3 | 20.8% | 30.7% | +8.9% | +27% / +55% |
| BMYBristol-Myers Squibb Company | 131.2 bn | 14.2 | 44.1% | 18.5% | −0.2% | +30% / +30% |
| TEVATeva Pharmaceutical Industries Limited | 48.8 bn | 97.4 | 6.6% | 3.6% | +4.3% | +56% / +326% |
| ZTSZoetis Inc. | 36.9 bn | 14.7 | 64.4% | 27.5% | +2.3% | −30% / −50% |
| ROIVRoivant Sciences Ltd. | 27.6 bn | — | -6.2% | -3,535.0% | −71.6% | +84% / +300% |
| RPRXRoyalty Pharma plc | 26.2 bn | 47.7 | 6.9% | 25.7% | +5.1% | +69% / +150% |
| UTHRUnited Therapeutics Corporation | 25.9 bn | 23.0 | 19.1% | 38.6% | +10.6% | +25% / +154% |
| INSMInsmed Inc | 24.1 bn | — | -72.5% | -39.9% | +66.7% | −47% / +340% |
| VTRSViatris Inc. | 22.1 bn | — | -23.6% | -23.9% | −3.0% | +80% / +109% |
| ALNYAlnylam Pharmaceuticals, Inc. | 21.6 bn | 8.1 | 126.6% | 52.8% | +65.2% | −64% / −4% |
| TGTXTg Therapeutics, Inc. | 9.4 bn | 22.5 | 100.3% | 55.2% | +87.3% | +85% / +381% |
| BLRXBioLineRx Ltd | 4.9 bn | — | -12.8% | -171.7% | −95.9% | −46% / −97% |
| AGIOAgios Pharmaceuticals, Inc. | 1.9 bn | — | -34.3% | -418.2% | +48.0% | +7% / +41% |
| SLSSELLAS Life Sciences Group, Inc. | 1.8 bn | — | -39.6% | — | −100.0% | +464% / +779% |
| ANIPAni Pharmaceuticals, Inc | 1.6 bn | 15.2 | 21.0% | 11.1% | +43.8% | −24% / +10% |
| SVRASavara Inc | 957.4 m | — | -105.5% | — | unavailable | −26% / +21% |
| PBYIPuma Biotechnology, Inc. | 551.8 m | 20.5 | 22.0% | 11.6% | −0.9% | +112% / +174% |
| STTKShattuck Labs, Inc. | 516.9 m | — | -39.2% | -5,256.8% | −82.5% | +145% / +163% |
1- and 3-year price returns: for ANIP from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | 44.18 Total return -38% · Per year -38% | 77.75 Total return 9% · Per year 9% | 116.62 Total return 63% · Per year 63% |
| 3 years | 52.40 Total return -27% · Per year -10% | 102.82 Total return 44% · Per year 13% | 167.94 Total return 134% · Per year 33% |
| 5 years | 62.16 Total return -13% · Per year -3% | 135.98 Total return 90% · Per year 14% | 241.83 Total return 238% · Per year 28% |
- Exit P/E± 25.71
- Net margin± 17.99
- Annual revenue growth± 13.42
- Annual dilution± 1.51
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
ANI Pharmaceuticals is a diversified biopharmaceutical company operating across Rare Disease, Generics and Brands, with Cortrophin Gel and ILUVIEN at the centre of its growth. It is now expanding its sales force for acute gouty arthritis flares as its Rare Disease business scales 123. Net revenues reached 883.4 million USD in fiscal 2025 1 and 266.0 million USD in Q2 2026 3.
SWOT
Strengths
- A diversified portfolio across three segments, with a fast-growing key product and a well-stocked generic launch calendar 13.
- Three owned plants capable of complex formulations and controlled substances give a manufacturing edge in niches with fewer competitors 1.
- Positive operating cash flow and reaffirmed 2026 guidance suggest solid capacity to fund investment 23.
Weaknesses
- Reliance on Cortrophin Gel means a large share of revenue depends on one product 1.
- Debt taken on after the Alimera acquisition limits available cash flow and carries restrictive financial covenants 12.
- Several products are made by third parties, some as single sources, exposing the company to supply interruptions 1.
Opportunities
- The acute gout expansion opens a large target population, mostly treated by podiatrists and primary care physicians 3.
- More generic launches and a focus on injectable and PIV niches could add new revenue streams 13.
- The share repurchase program and strategic acquisitions in rare disease are further routes to create value 13.
Risks
- Dependence on Cortrophin Gelhigh
A significant share of revenue comes from a single product, and risks around acceptance by physicians, payers and patients could affect results 1.
- Post-acquisition debthigh
The senior credit facility and convertible notes carry financial covenants and operating restrictions. A breach could lead to acceleration of repayment 1.
- Supply chainmedium
Single-source API and third-party manufacturing of key products could lead to disruptions if a supplier fails or if FDA inspections intervene 1.
- ILUVIEN patent expirymedium
Patent protection for key aspects of ILUVIEN and YUTIQ is narrowing, which could accelerate competition 1.
- Regulatory compliancelow
Healthcare laws, Medicaid programs and quality standards carry penalties if not met, and products marketed without NDA or ANDA approval could be required to be withdrawn 1.
Investment thesis
What would need to be true (bull case)
- If the acute gout expansion keeps generating new cases, Cortrophin Gel growth could exceed the current guidance 3.
- Diversification across three segments and frequent generic launches could stabilise revenue even if one product slows 13.
- Strong operating cash flow and the buyback program could support shareholder value if execution stays solid 23.
What would break the thesis
- If Cortrophin Gel slows or a competitor launches a more effective product, company revenue could decline materially 1.
- Accumulated debt and financial covenants could limit flexibility, especially if quarterly results fall short of expectations 12.
- ILUVIEN patent expiry and generic price pressure could compress margins over the medium term 1.
What to watch
- Cortrophin Gel sales trajectory in the acute gout expansionQ3 2026
- Detailed SYNCHRONICITY trial data for ILUVIEN in NIU-PSQ4 2026
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
ANI Pharmaceuticals states its mission as 'Serving Patients, Improving Lives' and develops, manufactures and commercializes therapeutics through Rare Disease, Generics and Brands 1. The September 2024 acquisition of Alimera Sciences added ILUVIEN and YUTIQ, and ILUVIEN now carries both DME and NIU-PS indications in the U.S. 1. The company runs three plants in the U.S. and closed its Oakville, Ontario facility as of March 2023 1.
Segments
Market context
The U.S. generic pharmaceutical market is competitive, where price and supply reliability decide share, and competition tends to lower average selling prices over time 1. In the ACTH niche and intravitreal ophthalmology, the company points to high barriers to genericization 13. Cortrophin Gel targets an estimated addressable population of about 285000 patients with acute gout 3.
Consolidation of customer groups and partnerships between wholesalers and pharmacy chains can reduce sales volumes and prices, particularly for generics 1. Returns, allowances and chargeback policies may reduce revenues in future periods 1.
Trends
- Expansion into acute gouttailwind
The dedicated sales force for acute gout flares was fully operational by the end of June 2026 and has generated a large funnel of new patient cases 3. If this expansion holds, it could support Cortrophin Gel growth above the current trajectory 3.
- Patent expiry for ILUVIEN and YUTIQheadwind
The company warns that patents protecting key aspects of ILUVIEN and YUTIQ could expire in the near to medium term, which could erode exclusivity 1.
- Pricing and reimbursement pressuremixed
Access to reimbursement and payer formulary acceptance condition Cortrophin Gel sales 1. Changes in government pricing programs and Medicaid rebates could have material effects 1.
- Generic growth under cost pressuremixed
Generic launches and the focus on injectables, PIV and CGT filings create opportunities but also require R&D spending and reliance on third parties for manufacturing 13. SG&A rose in 2026 as the sales team expanded 3.
Competitive position
The company faces competition from major pharmaceutical companies, specialty pharmaceutical firms and biotechnology companies, both for current products and future ones 1. In generics, competition is based on price, contract terms, service levels and reliability 1.
For Cortrophin Gel, competition comes from other ACTH products and alternative treatments for arthritis and autoimmune conditions, while for ILUVIEN it comes from other intravitreal implants 1. The sources do not name specific competitors by ticker.
- Other generic manufacturers
Direct competitors in generics, where price and service decide, cited generically in company sources 1.
- Specialty pharmaceutical and biotechnology companies
Competitors in rare diseases and branded products that could develop more effective alternatives, cited generically 1.
- Other ACTH therapies and gout treatments
Therapeutic alternatives to Cortrophin Gel that could shift market share 1.
- Other intravitreal implants for macular edema
Competing treatments for ILUVIEN that could limit its growth 1.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
No news in our archive over the last 180 days.
SEC filings
- Current report24 Aug 2026Departure or appointment of officers · Financial statements and exhibits
- Quarterly report07 Aug 2026
- Current report07 Aug 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Current report21 May 2026Departure or appointment of officers · Shareholder vote · Financial statements and exhibits
- Current report13 May 2026Regulation FD disclosure · Financial statements and exhibits
- Quarterly report08 May 2026
- Current report08 May 2026Results of operations · Financial statements and exhibits
- Proxy statement09 Apr 2026
- Current report07 Apr 2026Item 4.01 · Financial statements and exhibits
- Current report03 Mar 2026Regulation FD disclosure · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / ANI Pharmaceuticals, Inc. · 27 Feb 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / ANI Pharmaceuticals, Inc. · 07 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / ANI Pharmaceuticals, Inc. · 07 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.