Ani pharmaceuticals reports record third quarter 2023 financial results and raises full-year 2023 guidance

Third quarter 2023 financial results -- record quarterly net revenues of $131.8 million, representing year-over-year growth of 57.3% ; net income available to common shareholders of $9.5 million and diluted gaap income per share of $0.45 -- -- record quarterly adjusted non-gaap ebitda of $36.5 million representing year-over-year growth of 98.3 % ; adjusted non-gaap diluted earnings per share of $1.27 -- -- lead rare disease asset, purified cortrophin® gel (repository corticotrophin injection usp) 80 u/ml (cortrophin gel) reported net sales of $29.7 million, a year-over-year increase of 135.9% -- -- generics, established brands and other reported net sales of $102.1 million, representing year-over-year growth of 43.4% -- full year 2023 guidance -- company raises guidance: net revenue to $468 million to $478 million from $425 million to $445 million; adjusted non-gaap ebitda to $128 million to $133 million from $115 million to $125 million; adjusted non-gaap earnings per share to $4.29 to $4.57 from $3.62 to $4.11 -- -- company is raising cortrophin gel specific revenue guidance to $100 million t o $107 million from $90 million to $100 million, representing 139.9% to 156.7% growth as compared to $41.7 million recognized in 2022 -- -- mid-point of revised total company guidance represents year-over-year growth in net revenues of 49.5% , adjusted non-gaap ebitda of 133.6% , and adjusted non-gaap earnings per diluted share of 225.7% -- company highlights -- continued strong momentum for cortrophin gel; record number of new patient starts and new cases initiated in the third quarter of 2023; acth market posted six consecutive quarters of year-over-year growth according to iqvia -- -- continued increase in new unique prescribers, including growth with prescribers who are naive to acth therapy; ongoing strength in targeted specialties of neurology, nephrology, rheumatology and continued gains in pulmonology -- -- announced fda approval and commercial availability of new 1-ml vial size of cortrophin gel, the only approved purified corticotrophin indicated for the treatment of acute gouty arthritis flares; received specific j-code to support physician administration of 1 ml vial -- -- company's generics and established brands businesses continued to respond to pharmaceutical shortages arising from supply-chain disruptions by leveraging the company's operational excellence and u.s.-based manufacturing footprint; softening seen with specific market opportunities that persisted in prior quarters -- -- company's strong r&d organization delivered five new product launches and filed three new andas and two new 505(b)(2) applications in the quarter; retained number two ranking in competitive generic therapy (cgt) approvals -- -- generated $74.2 million in cash from operating activities (year-to-date), ending q3 with $193.1 million in cash -- baudette, minn., nov. 08, 2023 (globe newswire) -- ani pharmaceuticals, inc. (nasdaq: anip) (ani or the company) today announced business highlights and financial results for the three months ended september 30, 2023.
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