ANI PHARMACEUTICALS REPORTS RECORD FIRST QUARTER 2024 FINANCIAL RESULTS AND REITERATES 2024 GUIDANCE
May 13, 2024 at 11:24 am EDT
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BAUDETTE - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the three months ended March 31, 2024.
Nikhil Lalwani, President and CEO of ANI stated, Our record first quarter results demonstrate strength across all of our business segments. Our lead Rare Disease asset Cortrophin Gel experienced another quarter of robust year-over-year growth as prescription demand increased across our core specialties and our recent investments to expand awareness and utilization in new specialties began to yield results. We continue to believe that Cortrophin Gel has a long runway of growth driven by increasing market penetration and expansion of the overall ACTH market. This was further evidenced in April by achieving the highest number of new patient starts since launch.
Our Generics, Established Brands and Other segment also delivered strong performance in the first quarter. We are proud to report another quarter of double-digit increase in Generics revenue supported by strong new launch execution and operational excellence. We are energized by our first quarter results and look forward to building momentum throughout 2024 as we remain committed to our purpose of Serving Patients, Improving Lives , concluded Mr. Lalwani.
First Quarter and Recent Business Highlights
Rare Disease Segment
Revenues for the Company s lead asset, Cortrophin Gel, totaled $36.9 million for the first quarter of 2024, an increase of 126.2% over the same period in 2023, driven by increased volume. During the quarter, the Company saw continued prescription growth across its core specialties of neurology, rheumatology, and nephrology, as well as traction in its newer specialties of pulmonology and ophthalmology. The Company continues to believe that its Rare Disease business remains ANI s largest future growth driver and is actively exploring opportunities to acquire assets and/or establish partnerships to increase the scope and scale of the business.
Generics, Established Brands and Other Segment
Revenues for generic pharmaceuticals products, established brands and other grew 11.1% year-over-year in the first quarter of 2024. ANI s Generics business launched six new products during the quarter, including a Competitive Generic Therapy (CGT) product with 180-day exclusivity. The Company retained its number two ranking for CGT approvals and top 15 ranking for overall generic approvals.
About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin Gel, strengthening our generics business with enhanced research and development capability, innovation in established brands and leveraging our U.S. based manufacturing capabilities.
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, 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: Cortrophin Gel is our first rare disease pharmaceutical product; to the extent we are not able to continue to achieve commercial success with this product, including expanding the market and gaining market share, our business, financial condition, and results of operations will be negatively impacted; our approved products, including Cortrophin Gel, may not achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; acquisitions and other investments could disrupt our business and harm our financial position and operating results; the limited number of suppliers for our active pharmaceutical ingredients could result in lengthy delays in production if we need to change suppliers; delays or failure in obtaining or maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA and other regulatory agencies, including drug recalls; acceptance of our products at levels that will allow us to achieve profitability; 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; our dependence on single source suppliers of ingredients due to the time and cost to validate a second source of supply; 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 between Israel and Gaza, or conflicts relating to 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.
ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company, which serves patients in need by developing, manufacturing and marketing branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Its three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products. The Company has a commercial portfolio of 116 products with a variety of indications and a robust portfolio of pipeline products. It has acquired the NDAs for and market Atacand, Atacand HCT, Arimidex, Casodex, Lithobid, Vancocin, Inderal LA, Inderal XL, InnoPran XL, Oxistat, Veregen, and Pandel. The Company sources the raw materials for its products from both domestic and international suppliers.
ANI PHARMACEUTICALS, INC. 
