Overview of Financial Performance

ANI Pharmaceuticals, Inc. (ANI) is a diversified pharmaceutical company that develops, manufactures, and markets branded and generic prescription pharmaceuticals. In September 2024, ANI acquired Alimera Sciences, Inc. (Alimera), strengthening its Rare Disease business and expanding its global footprint.

For the first quarter of 2025, ANI reported total net revenues of $197.1 million, an increase of 43.4% compared to the same period in 2024. This strong performance was driven by growth across both of ANI’s reportable segments - Rare Disease and Brands, and Generics and Other.

Rare Disease and Brands Segment

The Rare Disease and Brands segment, which includes ANI’s rare disease and branded pharmaceutical products, generated net revenues of $94.1 million in Q1 2025, up 50.3% from the prior year period. This was primarily due to the addition of ILUVIEN and YUTIQ from the Alimera acquisition, as well as increased volume of Cortrophin Gel.

Cortrophin Gel, ANI’s lead rare disease product, saw net revenues increase 43.1% to $52.9 million, reflecting overall growth in the ACTH market and market share gains. ILUVIEN and YUTIQ, two ophthalmology products acquired from Alimera, contributed $16.1 million in their first full quarter of sales.

The Brands portfolio, which includes various branded pharmaceutical products, generated $25.1 million in net revenues, a slight decrease of 2.2% compared to Q1 2024. This was due to a net decrease in sales volume, though ANI was able to capitalize on supply chain disruptions for competing products to achieve some incremental volume gains.

Generics and Other Segment

The Generics and Other segment, which includes generic pharmaceutical products as well as royalties and other pharmaceutical services, reported net revenues of $103.0 million, an increase of 37.7% year-over-year.

Generic pharmaceutical product net revenues grew 40.5% to $98.7 million, driven by the launch of Prucalopride Tablets in late 2024 which benefited from 180-day exclusivity, as well as increased volumes from new product launches in 2024 and 2025. However, ANI expects generic revenues to decline in the second half of 2025 due to the expiration of exclusivity for Prucalopride.

Revenues from royalties and other pharmaceutical services were $4.4 million, down 5.1% compared to the prior year period.

Profitability and Expenses

Cost of sales, excluding depreciation and amortization, increased 48.6% to $73.0 million in Q1 2025, primarily due to the significant growth in sales volumes and an increase in royalty-bearing products. As a percentage of net revenues, cost of sales rose from 35.8% to 37.1%.

Other operating expenses, net, increased 44.0% to $97.9 million. This was driven by a $28.5 million (59.4%) increase in selling, general and administrative expenses to support the growth of the business, including investment in the Rare Disease sales and marketing infrastructure. Depreciation and amortization expense also increased by $8.2 million (55.9%) due to the amortization of intangible assets acquired in the Alimera transaction.

However, ANI recognized a $12.1 million gain from the fair value adjustment of contingent consideration related to prior acquisitions. This, combined with the $5.3 million gain on the sale of a former manufacturing site in Q1 2024, helped offset the increase in other operating expenses.

Overall, ANI reported operating income of $26.2 million in Q1 2025, up from $20.3 million in the prior year period. Net income was $15.7 million, compared to $18.2 million in Q1 2024, with the decrease primarily attributable to a $10.6 million unrealized loss on the company’s investment in equity securities.

Liquidity and Capital Resources

To finance the Alimera acquisition, ANI entered into a new credit agreement in August 2024, which provides for a $325 million senior secured term loan facility (Term Loan A) and a $75 million senior secured revolving credit facility. The Term Loan A has a maturity date of September 16, 2029 and bears interest at approximately 6.92% as of March 31, 2025.

Additionally, in August 2024, ANI issued $316.3 million of 2.25% Convertible Senior Notes due 2029. The net proceeds from the notes, along with cash on hand, were used to repay ANI’s previous senior secured credit facility.

ANI believes its current financial resources, including the new credit facilities and convertible notes, will be sufficient to meet its working capital requirements and debt obligations for at least the next 12 months and the foreseeable future.

Acquisition of Alimera Sciences

The acquisition of Alimera, which closed on September 16, 2024, was a transformative event for ANI. Alimera’s ILUVIEN and YUTIQ products, which treat diabetic macular edema and non-infectious uveitis, respectively, have strengthened ANI’s Rare Disease business and expanded its global footprint.

Under the terms of the acquisition, Alimera shareholders received $5.50 in cash per share, as well as contingent value rights (CVRs) that entitle them to potential milestone payments based on future ILUVIEN and YUTIQ net revenues. ANI also repaid $72.5 million of Alimera’s outstanding debt as part of the transaction.

The addition of Alimera’s direct marketing operations in Europe, as well as its partnerships in other international markets, is expected to provide significant commercial synergies and growth opportunities for the combined company’s ophthalmology portfolio, including Cortrophin Gel.

Outlook and Strategic Initiatives

Going forward, ANI plans to continue expanding its Rare Disease business through a combination of organic growth and strategic acquisitions. The company sees significant potential to unlock additional growth for the ILUVIEN and YUTIQ franchise by leveraging commercial synergies and execution.

In March 2025, the FDA approved an expanded label for ILUVIEN to include the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, in addition to its existing indication for diabetic macular edema. This expanded label provides ANI with an opportunity to further grow ILUVIEN’s market presence in the U.S.

ANI also remains focused on strengthening its Generics and Other segment through continued investment in research and development and a focus on niche, lower competition opportunities such as injectables, Paragraph IV filings, and products with competitive generic therapy (CGT) designations.

The company continues to evaluate potential acquisitions and other strategic transactions that could complement its existing portfolio, infrastructure, and capabilities or provide opportunities to expand its existing business.

Conclusion

ANI delivered strong financial results in the first quarter of 2025, with double-digit revenue growth across both of its reportable segments. The acquisition of Alimera has significantly strengthened the company’s Rare Disease business and expanded its global reach, while the new credit facilities and convertible notes have provided ample liquidity to support the company’s strategic initiatives.

Looking ahead, ANI remains focused on driving organic growth in its Rare Disease and Generics businesses, while actively pursuing complementary acquisitions to further enhance its capabilities and market position. The company’s diversified portfolio, robust pipeline, and prudent financial management position it well to deliver long-term sustainable growth and value for its shareholders.