Aug 7, 2026, 7:00 AM ETHealthcare

ANI Pharmaceuticals — Second Quarter 2026 Earnings Summary

ANIPANI PHARMACEUTICALS INC

Financial Performance

Total net revenues reached $266.0 million for the quarter, a 25.9% increase year-over-year compared to $211.4 million in Q2 2025.
Quarterly GAAP net income available to common shareholders was $24.7 million ($1.05 per diluted share), compared to $8.1 million ($0.36 per diluted share) in the prior year period.
Adjusted non-GAAP EBITDA was $71.6 million, a 32.4% increase year-over-year from $54.1 million in Q2 2025.
Adjusted non-GAAP diluted earnings per share were $2.21, up from $1.80 in the prior year period.
GAAP gross margin decreased to 62.4% from 64.7% in the prior year; non-GAAP gross margin decreased to 62.6% from 64.9%.
Research and development expenses decreased 10.8% to $14.7 million on a GAAP basis and 11.4% to $14.1 million on a non-GAAP basis.
Selling, general, and administrative expenses increased 12.1% to $91.7 million on a GAAP basis and 20.2% to $80.7 million on a non-GAAP basis.
Cash flow from operations was $115.0 million on a year-to-date basis.
As of June 30, 2026, the company held $360.2 million in unrestricted cash and cash equivalents and $274.5 million in net accounts receivable.
Outstanding debt totaled $620.9 million in principal value, inclusive of senior convertible notes.

Reaffirmed full-year 2026 total net revenue guidance of $1,080 million to $1,140 million.
Reaffirmed full-year 2026 adjusted non-GAAP EBITDA guidance of $285 million to $300 million.
Modestly adjusted Cortrophin Gel net revenue guidance to $520 million to $540 million, reflecting expected 50-55% growth for the full year (previously $540 million to $575 million).
Maintained ILUVIEN net revenue guidance of $78 million to $83 million for the full year.
Reaffirmed full-year adjusted non-GAAP diluted EPS guidance of $9.19 to $9.69.
Expects full-year adjusted non-GAAP gross margin between 59.9% and 60.9%.
Anticipates approximately 21.5 million to 21.8 million shares outstanding for full-year adjusted non-GAAP diluted EPS calculations.
Expects the annual U.S. GAAP effective tax rate to be between 26% and 28%.

Rare Disease net revenues increased 30.7% to $135.8 million, driven by a 43.5% year-over-year increase in Cortrophin Gel net revenues to $117.1 million.
Cortrophin Gel growth was driven by existing specialties (Nephrology, Neurology, Ophthalmology, Pulmonology, Rheumatology) and a record number of new cases initiated in July.
The company's expansion to reach podiatrists and primary care physicians for acute gouty arthritis flares was fully operational as of June 30, 2026.
ILUVIEN net revenues decreased 16.1% to $18.7 million, primarily due to timing of international shipments.
Generics net revenues increased 9.7% to $99.1 million, driven by a partnered generic launch commencing in Q3 2025, new product launches, and operational outperformance.
The company launched 12 new Generics products year-to-date and is on track for at least 15 new product launches in 2026.
Brands net revenues decreased 10.5% to $11.8 million due to normalization in demand for certain products.
Brand royalties and other revenues recognized $17.7 million, including $9.7 million in royalties on pitolisant-based products and $8.0 million in development milestone revenue; an additional $2.0 million in milestone revenue is expected in Q3 2026.
The SYNCHRONICITY clinical trial for ILUVIEN in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) announced 6-month topline data, with detailed results anticipated at a medical conference in Q4 2026.

The Cortrophin Gel gout expansion targets an estimated addressable market of approximately 285,000 patients, primarily treated by podiatrists and primary care physicians.
Demand metrics for the gout expansion are positive, with over 95% of representatives generating multiple new patient cases and over a third of prescribers initiating two or more cases.
The company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which carries a combined label for DME and NIU-PS.

Risks include potential inability to achieve market acceptance levels required for profitability, delays in production due to reliance on single-source third-party contract manufacturing for key products like Cortrophin Gel and ILUVIEN, and supply chain disruptions affecting raw materials.
Regulatory risks include delays in FDA approvals or changes in policy by the FDA, DEA, and other agencies.
Financial risks include fluctuations in exchange rates, increased costs due to tariffs or macroeconomic disruptions, and competition from generic alternatives.
Intellectual property risks include the ability to protect rights and maintain licenses for third-party products.

CEO Nikhil Lalwani described the second quarter results as "outstanding" and noted the implementation of the "largest Rare Disease sales force expansion in our history."
Management expressed strong conviction in Cortrophin Gel's "sizable multi-year growth opportunity," citing positive leading indicators from the gout expansion and continued momentum in existing specialties.
The company highlighted a "solid track record of commercial execution and prudent capital allocation" positioning it well for continued shareholder value creation.

Effective May 8, 2026, the Board of Directors authorized a share repurchase program to buy up to $100.0 million in common stock through May 2029.
The company recognized a contingent consideration fair value adjustment of $(622) thousand in Q2 2026, compared to $1.277 million in the prior year period.
Litigation expenses and settlement proceeds totaled $673 thousand in Q2 2026, compared to $5.201 million in the prior year period.
Stock-based compensation was $11.4 million for the quarter.
The company will host a conference call and webcast on August 7, 2026, at 8:00 a.m. ET to discuss results.