ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) reported record second quarter 2026 financial results, highlighted by quarterly net revenues of $266.0 million, representing a 25.9% year-over-year increase. Purified Cortrophin Gel — the company's flagship repository corticotropin injection, an FDA-approved ACTH-based therapy used across multiple inflammatory conditions — generated net revenues of $117.1 million, up 43.5% year-over-year and accounting for approximately 44% of total quarterly net revenues. The company reported GAAP net income available to common shareholders of $24.7 million and adjusted non-GAAP EBITDA of $71.6 million, a 32.4% year-over-year increase. Diluted GAAP income per share was $1.05, and adjusted non-GAAP diluted earnings per share was $2.21. ANI reaffirmed its 2026 guidance for total net revenue of $1,080–$1,140 million and adjusted non-GAAP EBITDA of $285–$300 million.

Management Commentary

Nikhil Lalwani, President and CEO of ANI, stated: "In the second quarter, we delivered outstanding financial results, while we implemented the largest Rare Disease sales force expansion in our history. Leading indicators from our gout expansion for Cortrophin Gel are very positive, with the team rapidly delivering a large funnel of new patient cases, with significant breadth and depth of prescribing. The encouraging initial trends we are seeing from the gout expansion, and the continued momentum in our existing specialties, further support our conviction in Cortrophin Gel's sizable multi-year growth opportunity."

Lalwani added: "We are reaffirming our full year 2026 total net revenue guidance of $1,080–$1,140 million and adjusted non-GAAP EBITDA of $285–$300 million. Based on our results in the first half of 2026, we are modestly adjusting our Cortrophin Gel net revenue guidance to $520–$540 million, reflecting 50–55% growth for the full year. Our solid track record of commercial execution and prudent capital allocation combined with our strong balance sheet position us well for continued shareholder value creation."

Second Quarter and Recent Business Highlights

Rare Disease — Cortrophin Gel

Cortrophin Gel net revenues were $117.1 million for the second quarter of 2026, an increase of 43.5% over the same period in 2025. Year-over-year growth was driven primarily by existing specialty areas: Nephrology, Neurology, Ophthalmology, Pulmonology, and Rheumatology. Momentum in these specialties continued into the third quarter, with a record number of new cases initiated in July.

ANI's sales force expansion to reach podiatrists and primary care physicians for Cortrophin Gel in acute gouty arthritis flares was fully operational as of the end of June, as planned. The expansion represents a notable commercial shift for the product, extending its reach beyond specialty physicians into the primary care and podiatry settings where the majority of gout patients are managed. Key demand metrics from the gout expansion have been positive to date: over 95% of representatives have generated multiple new patient cases, and over a third of prescribers have initiated two or more cases. The company has observed balanced demand from both podiatrists and primary care physicians. The gout expansion targets an estimated addressable market of approximately 285,000 patients, the majority of whom are treated by podiatrists and primary care physicians.

Rare Disease — ILUVIEN

ILUVIEN net revenues were $18.7 million for the second quarter of 2026, a decrease of 16.1% over the same period in 2025, primarily due to the timing of international shipments. The company announced 6-month topline data from the Phase 4 open-label single-arm SYNCHRONICITY clinical trial in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) and anticipates presenting detailed results and additional analyses at a key medical conference attended by retina specialists in the fourth quarter of 2026.

Generics

Generics net revenues were $99.1 million in the second quarter of 2026, an increase of 9.7% over the same period in 2025, driven by new product launches including the partnered generic launch that commenced in the third quarter of 2025. ANI has launched 12 new Generics products year-to-date and is on track for at least 15 new product launches in 2026. The Generics segment serves as a diversified revenue engine alongside the Rare Disease business, leveraging ANI's U.S.-based manufacturing and R&D capabilities.

Brand Royalties and Other Revenues

The company recognized $17.7 million of revenue under the Harmony Agreement, consisting of $9.7 million in royalties on net sales of pitolisant-based products — the active ingredient in wakefulness therapies marketed by Harmony Biosciences — and $8.0 million based on work completed toward certain development milestones. The remaining development work is expected to be completed in the third quarter of 2026, at which point the company will recognize an additional $2.0 million in development milestone revenue. ANI will continue to earn low single-digit royalties on net sales of pitolisant-based products.

Brands

Brands net revenues were $11.8 million for the second quarter of 2026, a decrease of 10.5% over the same period in 2025, reflecting normalization in demand for certain products.

Corporate Highlights

Effective May 8, 2026, ANI's board of directors authorized a share repurchase program of up to $100.0 million in common stock through May 2029.

Second Quarter 2026 Financial Results

There were no sales of YUTIQ during the quarter ended June 30, 2026, as the company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS as of the second quarter of 2025. All comparisons are versus the same period in 2025 unless otherwise noted.

Total net revenues for the second quarter of 2026 were $266.0 million, an increase of 25.9%. Rare Disease net revenues, which include Cortrophin Gel and ILUVIEN, increased 30.7% to $135.8 million. Cortrophin Gel net revenues increased 43.5% to $117.1 million, driven primarily by increased volume. ILUVIEN net revenues decreased 16.1% to $18.7 million, impacted by shipment timing in certain international markets. Brands net revenues decreased 10.5% to $11.8 million due to demand normalization for certain products. Brand royalties and other revenues included $8.0 million in development milestone revenue and approximately $9.7 million in royalties under the Harmony Agreement. Generic pharmaceutical product net revenues increased 9.7% to $99.1 million, driven by continued strength in the partnered generic launch from the third quarter of 2025, new product launches, and commercial and operational outperformance.

On a GAAP basis, gross margin decreased from 64.7% to 62.4%, while on a non-GAAP basis, gross margin decreased from 64.9% to 62.6%. Both decreases were primarily due to higher sales of royalty-bearing products, including Cortrophin Gel and a partnered generic product launched in the third quarter of 2025, and the non-recurrence of prior-year revenues from Prucalopride. These effects were partially offset by revenue recognized under the Harmony Agreement.

On both GAAP and non-GAAP bases, research and development expenses decreased 10.8% to $14.7 million and 11.4% to $14.1 million, respectively, driven by the timing of ongoing and new projects supporting future Rare Disease and Generics growth.

GAAP selling, general, and administrative expenses increased 12.1% to $91.7 million, while non-GAAP SG&A increased 20.2% to $80.7 million. Both increases reflect incremental expenses from the initial marketing and recruitment for the Rare Disease team expansion targeting acute gouty arthritis, as well as an overall increase in activities supporting business growth.

On a GAAP basis, the company reported net income attributable to common shareholders of $24.7 million, or $1.05 per diluted share, compared to $8.1 million, or $0.36 per diluted share, in the prior year period. On a non-GAAP basis, adjusted diluted earnings per share was $2.21, compared to $1.80 in the prior year period.

Adjusted non-GAAP EBITDA for the second quarter of 2026 was $71.6 million, an increase of 32.4% from the second quarter of 2025, driven by increased net revenues and gross profit.

Liquidity

As of June 30, 2026, the company had $360.2 million in unrestricted cash and cash equivalents, $274.5 million in net accounts receivable, and $620.9 million in principal value of outstanding debt (inclusive of senior convertible notes). The company generated $115.0 million in cash flow from operations on a year-to-date basis.

Full Year 2026 Financial Guidance

ANI expects full-year total company adjusted non-GAAP gross margin between 59.9% and 60.9% and anticipates approximately 21.5 million to 21.8 million shares outstanding for the purpose of calculating full-year adjusted non-GAAP diluted EPS. The company expects its annual U.S. GAAP effective tax rate to be between 26% and 28% and will continue to tax-effect non-GAAP adjustments for the computation of adjusted non-GAAP diluted EPS at a rate of 26%.

Non-GAAP Financial Measures

ANI's management considers adjusted non-GAAP EBITDA an important financial indicator of operating performance, providing a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, asset ages, and compensation structures among comparable companies. Adjusted non-GAAP EBITDA is defined as net income excluding tax expense, net interest expense, net other expense (income), depreciation and amortization, non-cash stock-based compensation, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain (loss) on equity securities investments, litigation-related expenses and settlement payments, severance expenses, and certain other items that vary in frequency and impact.

Adjusted non-GAAP net income is defined as net income plus the foregoing adjustments, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income divided by diluted weighted average shares outstanding during the period.

Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes, as they are intended to be covered by capped call transactions. Accordingly, 340,000 shares and 345,000 shares for the three and six months ended June 30, 2026, respectively, have been excluded from the calculation.

ANI is not providing reconciliations for forward-looking full-year 2026 adjusted EBITDA or adjusted diluted EPS guidance because it does not currently have sufficient information to accurately estimate all variables and individual adjustments for such reconciliation.

Non-GAAP research and development expenses exclude non-cash stock-based compensation and certain other variable items. Non-GAAP selling, general, and administrative expenses exclude non-cash stock-based compensation, M&A transaction and integration expenses, litigation-related expenses and settlements, severance, and certain other variable items. Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization), divided by non-GAAP net revenues.

All non-GAAP measures should be considered in addition to, but not in lieu of, the most directly comparable GAAP financial measures. Reconciliations are provided in the accompanying financial tables.

Conference Call

ANI's management hosted a conference call and webcast on Friday, August 7, 2026, at 8:00 a.m. ET to discuss second quarter 2026 results. Links to access the webcast and conference call are available on the "Events & Presentations" page of the company's website at under the "Investors" section. A replay will remain accessible for up to one year.

About ANI Pharmaceuticals

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative and high-quality therapeutics. The company operates through its Rare Disease business (ophthalmology, rheumatology, nephrology, neurology, and pulmonology), its Generics business (leveraging R&D expertise, operational excellence, and U.S.-based manufacturing), and its Brands business. For more information, visit

Forward-Looking Statements

Statements in this release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements regarding the company's strategy, future operations, financial position, revenues, 2026 financial guidance, share repurchase program, preclinical studies, clinical trials, regulatory submissions and approvals, product commercialization and launches, market opportunity estimates, sales force expansion for Cortrophin Gel in acute gouty arthritis, anticipated growth opportunities for Cortrophin Gel and ILUVIEN, and positioning for shareholder value creation. Uncertainties and risks include the ability of approved products to achieve market acceptance; acquisition and investment execution; production delays and disruptions; supplier limitations; reliance on single-source contract manufacturing; FDA and other regulatory actions; supply chain disruptions and tariff impacts; exchange rate fluctuations; intellectual property protection; litigation; pricing reform; key personnel retention; and general business and economic conditions including inflationary pressures and geopolitical conditions. More detailed information is available in the company's filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements speak only as of the date of this release, and the company undertakes no obligation to update them.

Investor Relations:
Irina Koffler, Vice President, Investor Relations — Tel: 917-734-7387 — Email: Irina.koffler@anipharmaceuticals.com

Media Relations:
Argot Partners — Tel: 212-600-1494 — Email: ani@argotpartners.com

Source: ANI Pharmaceuticals, Inc.

Financial tables follow.

(1) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities. (2) Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes, as they are intended to be covered by capped call transactions. Accordingly, 340,000 shares and 345,000 shares for the three and six months ended June 30, 2026, respectively, have been excluded.