ANIP Tops Q2 Earnings, Stock Down on Cortrophin Sales View Cut

ANI Pharmaceuticals ANIP reported second-quarter 2026 adjusted EPS of $2.21, beating the Zacks Consensus Estimate of $2.01. The reported figure rose 23% year over year, driven by higher sales during the quarter.

Quarterly revenues totaled $266 million, up 26% from the year-ago period. The metric also beat the Zacks Consensus Estimate of $262.7 million.

The quarter reflected solid execution across the portfolio, led by continued momentum for Purified Cortrophin Gel and contributions from a newly monetized intellectual property licensing arrangement.

ANI's Rare Disease Business Shows Mixed Trends

Rare Disease revenues totaled $135.8 million, up 31% year over year but below the Zacks Consensus Estimate of $141 million.

Cortrophin Gel revenues of $117.1 million missed the Zacks Consensus Estimate of $120.4 million. Still, the metric rose 43.5%, primarily driven by existing specialties, including nephrology, neurology, ophthalmology, pulmonology and rheumatology.

ANIP shares fell more than 5% on Friday following the results announcement, likely reflecting investor concerns over lower-than-expected Cortrophin sales despite the broader earnings and revenue beat. These concerns were further amplified after management lowered its full-year outlook for the drug.

Year to date, the stock has lost 1% against the industry’s 5% growth.

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Iluvien revenues declined 16% year over year to $18.7 million, missing the Zacks Consensus Estimate of $20.7 million, mainly due to the timing of international shipments.

The company also reported $17.7 million in brand royalties and other revenues during the second quarter, comprising $9.7 million in royalties on sales of pitolisant-based products and $8 million tied to work completed toward certain development milestones under its Harmony Biosciences HRMY licensing agreement. By contrast, Brands' revenues declined 10.5% year over year to $11.8 million as demand normalized for certain products.

In January, the company’s Novitium subsidiary entered into an agreement with Harmony Biosciences, under which ANIP out-licensed intellectual property related to pitolisant, marketed by HRMY under the brand name Wakix. The agreement generated a $15 million upfront license fee and includes low single-digit royalties on sales of pitolisant-based products. It provides for an additional $10 million in development milestones that management expects to be achieved in the second and third quarters of 2026.

ANIP's Generics Business Outperforms Expectations

Generic pharmaceutical product revenues increased 10% year over year to $99.1 million, exceeding the Zacks Consensus Estimate of $96.9 million. Growth reflected new product launches, continued strength from a partnered generic introduced in the third quarter of 2025 and commercial and operational outperformance.

ANIP has launched 12 generic products so far in 2026 and expects to launch at least 15 during the full year. The company also maintained its position as the second-ranked player in overall Competitive Generic Therapy (CGT) filings.

ANI's Higher Product Costs Pressure Margins

Adjusted gross margin contracted to 62.6% from 64.9% in the year-ago quarter. The decline primarily reflected higher sales of royalty-bearing products, including Cortrophin Gel and a partnered generic, along with the non-recurrence of prior-year Prucalopride revenues.

Adjusted selling, general and administrative expenses increased 20% to $80.7 million, reflecting spending on the Cortrophin gout expansion and broader investments supporting business growth. Adjusted research and development expenses declined 11% to $14.1 million.

ANIP Cuts 2026 Cortrophin Sales View but Maintains Broader Outlook

The company reaffirmed its 2026 total revenue guidance of $1.08-$1.14 billion and adjusted EBITDA outlook of $285-$300 million. Adjusted earnings are still projected between $9.19 and $9.69 per share.

However, ANIP lowered its full-year 2026 Cortrophin Gel revenue outlook to $520-$540 million from the previous guidance of $540-$575 million. Management said the revision principally accounts for first-half results, while expectations for the second half remain largely intact. The new range still represents 50-55% growth from 2025.

Despite the lowered guidance, management remained optimistic about Cortrophin sales for the remainder of the year. It expects third-quarter revenues of $143-$153 million, followed by further sequential growth in the fourth quarter as the gout sales force contributes more meaningfully.

The company maintained the outlook for Iluvien revenues in the range of $78-$83 million.

ANIP Details Cortrophin Demand and Gout Commercial Expansion

ANIP's gout-focused Cortrophin commercial expansion was fully operational by the end of June. More than 95% of the new sales representatives generated multiple patient cases, while more than a third of prescribers initiated at least two cases. Demand was balanced between primary care physicians and podiatrists.

Management said momentum in existing specialties continued into the third quarter, with July recording the highest number of new patient cases initiated. Ophthalmology volumes also doubled year over year during the second quarter.

ANIP’s Zacks Rank

The stock currently has a Zacks Rank #4 (Sell).

ANI Pharmaceuticals, Inc. Price

 

ANI Pharmaceuticals, Inc. price | ANI Pharmaceuticals, Inc. Quote

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This article originally published on Zacks Investment Research (zacks.com).

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