ANI Pharmaceuticals Q2 Earnings Call Highlights

ANI Pharmaceuticals (NASDAQ:ANIP) reported record second-quarter revenue and adjusted EBITDA as growth in its Cortrophin Gel rare-disease franchise and generics business lifted results, while the company modestly reduced its full-year Cortrophin revenue outlook to reflect first-half performance.

Total net revenue rose 26% year over year to $266 million in the second quarter of 2026. Adjusted EBITDA increased 32% to a record $71.6 million, while adjusted diluted earnings per share were $2.21, compared with $1.80 in the prior-year quarter.

President and CEO Nikhil Lalwani said the company’s performance came as ANI executed its largest rare-disease sales force expansion, increasing its commercial team by 50% to about 180 representatives. The expansion includes a gout-focused organization targeting podiatrists and primary-care providers.

Cortrophin Growth and Gout Expansion

Cortrophin Gel generated $117.1 million in second-quarter revenue, up 43% from a year earlier and 56% from the first quarter. Lalwani said growth during the quarter was primarily driven by the company’s existing specialties, including rheumatology, nephrology, neurology, ophthalmology and pulmonology.

Chris Mutz, senior vice president and head of ANI’s rare disease business, said July produced the highest monthly number of new cases initiated in the company’s existing specialty business. He also said Cortrophin volumes in ophthalmology doubled year over year during the second quarter.

The company completed the rollout of its gout-focused sales organization by the end of June. ANI said more than 95% of the new representatives had generated multiple new cases, while more than one-third of prescribers had initiated two or more patient cases. The company said it has seen initial and repeat prescribing from both primary-care and podiatry offices.

During the question-and-answer session, Lalwani said the gout expansion had a limited contribution to reported second-quarter revenue because of the timing of its deployment. ANI expects measurable revenue from the initiative in the third quarter and a larger contribution in the fourth quarter, when the representatives will have been in the field longer.

ANI reduced its 2026 Cortrophin Gel revenue guidance to $520 million to $540 million, saying the revision primarily reflected actual first-half results. Management said its expectations for the second half remain largely intact and that the new range still represents 50% to 55% growth over 2025.

For the third quarter, ANI expects Cortrophin revenue of $143 million to $153 million, followed by further sequential growth in the fourth quarter. Lalwani cited ongoing momentum in existing specialties, the expected ramp from the gout sales force and seasonal channel and insurance dynamics as factors supporting the fourth-quarter outlook.

Management said it sees nearly 1 million addressable patients across Cortrophin indications and described ACTH therapies as underpenetrated. Lalwani said penetration remains “very, very low” across the addressable market.

ILUVIEN and Generics Results

ILUVIEN net revenue was $18.7 million, down 16% from the prior-year period, which Chief Financial Officer Stephen Carey attributed primarily to the timing of international shipments. ANI maintained its full-year ILUVIEN revenue guidance of $78 million to $83 million and expects stronger revenue in the second half than in the first half.

The company said it reported top-line results from the Phase IV open-label SYNCHRONICITY trial in non-infectious uveitis of the posterior segment, or NIU-PS. ANI plans to present detailed results and additional analyses at a medical conference in the fourth quarter. Mutz said the findings are expected to support engagement with retina specialists treating NIU-PS.

Generics revenue increased 10% year over year to $99.1 million. The company said the increase reflected a partner generic launch that began in the third quarter of 2025, new product launches, and commercial and operational performance. ANI has launched 12 generics so far in 2026 and remains on track to launch at least 15 for the full year, according to Lalwani.

ANI also recognized $17.7 million in second-quarter revenue associated with its licensing transaction with Harmony Biosciences. That figure included $9.7 million in royalty income on WAKIX sales and $8 million tied to development-milestone work completed during the quarter. Carey said ANI expects to recognize the remaining $2 million related to that development milestone in the third quarter.

Margins, Cash Flow and Outlook

Non-GAAP gross margin was 62.6%, down about 230 basis points year over year due to product mix. Non-GAAP research and development expense declined 11% to $14.1 million, primarily because of the timing of generic R spending. Non-GAAP selling, general and administrative expense increased 20% to $80.7 million, reflecting the gout expansion and increased activity supporting the business.

ANI ended the quarter with $360.2 million of unrestricted cash, up $74.6 million from Dec. 31, 2025. Operating cash flow totaled $56.7 million in the quarter and $115 million for the first six months of the year. The company had $620.9 million in outstanding principal debt as of June 30, with gross leverage of 2.4 times and net leverage of one times trailing-12-month adjusted EBITDA.

• Total 2026 net revenue guidance was reaffirmed at $1.08 billion to $1.14 billion.
• Adjusted EBITDA guidance was maintained at $285 million to $300 million.
• Adjusted diluted EPS guidance was maintained at $9.19 to $9.69.
• Adjusted gross-margin guidance remained 59.9% to 60.9%.

Carey said ANI expects third-quarter company revenue to be modestly higher than the second quarter, with sequential growth accelerating in the fourth quarter. Third-quarter adjusted EBITDA is expected to decline sequentially due in part to lower Harmony milestone revenue and the first fully loaded quarter of expenses from the gout expansion. The company expects fourth-quarter EBITDA to be its highest of the year as Cortrophin revenue grows.

Lalwani said ANI continues to evaluate business-development opportunities to expand the scope and scale of its rare-disease business, focusing on commercial or near-commercial assets that could be supported by its sales force, market-access capabilities, medical affairs organization and patient-support infrastructure.

About ANI Pharmaceuticals (NASDAQ:ANIP)

ANI Pharmaceuticals, Inc is a United States–based specialty pharmaceutical company focused on the development, manufacturing and commercialization of generic and branded prescription drugs. The company operates as an end-to-end provider, offering services that range from active pharmaceutical ingredient (API) production and formulation development to finished dosage form manufacturing and packaging.

ANI's product portfolio encompasses injectable and oral therapies across several therapeutic areas, including endocrinology, oncology, pain management and respiratory care.

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