ANI Pharmaceuticals Reports Record Third Quarter 2024 Financial Results and Raises 2024 Guidance

ANIP

BAUDETTE - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the three months ended September 30, 2024.

'I am very pleased to report our third quarter results as we continue to execute against our purpose of 'Serving Patients, Improving Lives,'' said Nikhil Lalwani, President & CEO of ANI. 'During the quarter, our team drove record performance for both our lead Rare Disease asset Cortrophin Gel and our Generics business. We also put a new, more efficient and effective capital structure in place and completed the acquisition of Alimera, which is highly synergistic to our Rare Disease business. We believe our proven commercial execution capabilities can further unlock the potential for ILUVIEN and YUTIQ, two growing and durable assets, as well as accelerate the growth of Cortrophin Gel in ophthalmology.'

'Based on our strong third quarter results, the continued momentum across the business, and the addition of ILUVIEN and YUTIQ, we are pleased to raise our full year 2024 guidance,' concluded Mr. Lalwani.

As compared to estimated interest expense that would have been incurred if the new principal amount of debt was subject to rates that would have applied under the previous debt capital structure.

Third Quarter and Recent Business Highlights

Rare Disease Segment

Revenues for ANI's lead asset, Cortrophin Gel, totaled $52.6 million for the third quarter of 2024, an increase of 76.8% over the same period in 2023, driven by increased volume from both overall ACTH market growth and share growth. During the quarter, the Company saw increasing demand with the highest number of quarterly new patient starts and unique prescribers since launch and achieved growth across all targeted specialties - ophthalmology, neurology, rheumatology nephrology and pulmonology. ANI continued taking steps to further strengthen the Cortrophin Gel franchise and completed development of a Pre-Filled Syringe for Cortrophin Gel and submitted a supplemental new drug application (sNDA) in October.

Generics Business

ANI's Generics business achieved 10.8% year-over-year growth in the third quarter of 2024, driven by strong R&D capabilities and operational excellence leveraging its U.S. based manufacturing footprint and robust FDA compliance track record. The Company launched five new products during the quarter, several into limited competition markets, and one additional product so far in the fourth quarter, bringing the year to date total to sixteen.

Closed Acquisition of Alimera Sciences

On September 16, 2024, the Company completed the acquisition of Alimera Sciences. The transaction significantly expands the scope and scale of ANI's Rare Disease business with the addition of two growing and durable ophthalmology products, ILUVIEN and YUTIQ. Integration is progressing as anticipated and the Company now has a 45-person ophthalmology sales force promoting ILUVIEN, YUTIQ and Cortrophin. In addition, the Company remains on track to capture approximately $10 million of identified cost synergies in 2025.

The acquisition contributed $3.9 million of revenues to ANI for the last two weeks of the quarter, and the Company expects revenue between $30.0 million and $32.0 million for the year (for the period of September 16, 2024 through December 31, 2024).

New Capital Structure

During the quarter, ANI completed an offering of $316.25 million aggregate principal amount of 2.25% convertible senior notes due September 1, 2029, repaid its existing senior secured term loan facility ($292.5 million that carried an interest rate of SOFR+6.0%), and entered into a new senior secured credit agreement consisting of a $325.0 million delayed draw term loan facility (initial interest rate SOFR+2.75%) and $75.0 million revolving credit facility. The Company expects these capital structure changes to reduce interest expense by approximately $39.0 million on an annualized basis as compared to estimated interest expense that would have been incurred if the new principal amount of debt was subject to rates that would have applied under the previous debt capital structure.

Liquidity

As of September 30, 2024, the Company had $145.0 million in unrestricted cash and cash equivalents, $196.4 million in net accounts receivable and $641.3 million in principal value of outstanding debt (inclusive of our senior convertible notes). The Company generated year-to-date cash flow from operations of $48.2 million.

About ANI

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of 'Serving Patients, Improving Lives' by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing and its Established Brands business.

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company's generic pipeline, 2024 guidance, other statements that are not historical in nature, particularly those that utilize terminology such as 'anticipates,' 'will,' 'expects,' 'plans,' 'potential,' 'future,' 'believes,' 'intends,' 'continue,' other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: our ability to continue to achieve commercial success with Cortrophin Gel, our first rare disease pharmaceutical product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; the ability of our approved products, including Cortrophin Gel, and products acquired in the acquisition of Alimera, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the risks that our acquisitions and investments, including the recent acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays in production, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel and products acquired in the acquisition of Alimera; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, and other risks and uncertainties that are described in ANI's Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.

Contact:

Lisa M. Wilson

Tel: 212-452-2793

Email: lwilson@insitecony.com

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