Full Year 2023 Guidance<\/i><\/b><\/p>\n
— Raises Company net revenue guidance to $385 million to $410 million from $360 million to $385 million; adjusted non-GAAP EBITDA guidance to $97 million to $107 million from $78 million to $88 million; adjusted non-GAAP earnings per share to $2.99 to $3.45 from $2.09 to $2.59 —<\/i><\/p>\n
— Mid-point of revised guidance represents year-over-year growth in net revenues of approximately 26%, adjusted non-GAAP EBITDA of <\/i>approximately <\/i>83% and adjusted non-GAAP earnings per diluted share of <\/i>approximately <\/i>137% —<\/i><\/p>\n
— Maintains Cortrophin Gel net revenue guidance at $80 million to $90 million (representing 92% – 116% growth versus 2022); maintains Cortrophin Gel SG&A estimate at ~10% increase versus 2022, including modest sales force expansion —<\/i><\/p>\n
Company Highlights<\/i><\/b><\/p>\n
— Accelerating momentum of Cortrophin Gel launch; Record number of cases initiated in the first quarter of 2023 and record number of new patient starts and cases initiated in the month of April 2023; ACTH market continues to show year-over-year growth for ten consecutive months according to IQVIA —<\/i><\/p>\n
— Strengthened efforts to increase market awareness of Cortrophin Gel through peer-to-peer education and completed modest sales force expansion into Pulmonology; Continued increase in the number of unique and repeat prescribers —<\/i><\/p>\n
— Operational excellence in generics and branded pharmaceuticals results in significant year-over-year and sequential revenue growth and capture of market opportunities <\/i>—<\/i><\/p>\n
— FDA inspection of East Windsor, NJ facility completed in March 2023 with zero 483s and No Action Indicated status —<\/i><\/p>\n
— Retained top ten ranking for new ANDA approvals and second ranking for Competitive Generic Therapy approvals —<\/i><\/p>\n
BAUDETTE, Minn.–(BUSINESS WIRE<\/a>)– \n\u201cOur outstanding performance in the first quarter of 2023 further demonstrates ANI\u2019s ability to compete and win across our core business segments. We are pleased to announce record quarterly net revenues and adjusted non-GAAP EBITDA and a significant increase to full-year 2023 guidance. Importantly, we continue to invest behind the launch of our foundational Rare Disease asset, Purified Cortrophin Gel. We continually strive to strengthen the team, improve our approach to servicing patient, physician and payor needs, and increase access to ACTH therapy for patients in need. These efforts have resulted in the further acceleration of our launch momentum with record quarterly new cases initiated in the first quarter of 2023, record monthly new patient starts and cases initiated in April 2023 and first quarter net revenues of Cortrophin Gel of $16.3 million in-line with our expectations,\u201d stated Nikhil Lalwani, President and CEO of ANI.<\/p>\n \n\u201cRobust results in our Generics, Established Brands and Others segment showcases ANI\u2019s ability to leverage our U.S. manufacturing footprint and our agility in operations to deliver timely solutions to our customers. During the past two years, we have enhanced ANI\u2019s operational excellence by combining long-standing strengths in manufacturing and our strong GMP track record with best-in-class research and development capabilities, all with a \u2018patient-first\u2019 orientation. This has enabled us to capture market demand arising from the numerous supply disruptions impacting patient access to much-needed medicines. We are pleased with the strong start to 2023 and look forward to continuing to serve patients in need and working hard to build on the growth momentum throughout the year,\u201d concluded Lalwani.<\/p>\n First Quarter 2023 Financial Highlights:<\/i><\/b><\/p>\n First Quarter and Recent Business Highlights:<\/b><\/p>\n Rare Disease Business Update<\/span><\/p>\n \nRevenues for Cortrophin Gel totaled $16.3 million in the first quarter, in line with internal expectations. The Company continues to see significant growth momentum as evidenced by a record number of new cases initiated in the first quarter of 2023 and new monthly records for new patient starts and new cases in April 2023. Importantly, the ACTH category, which had been declining since 2019, has experienced ten consecutive months of year-on-year growth from June 2022 \u2013 March 2023. In fact, the ACTH market has continued to see double-digit growth in volumes in each month of the first quarter of 2023.<\/p>\n \nThe Company has ramped-up promotional efforts to continue to build awareness of Cortrophin Gel through peer-to-peer education programs across target indications of Rheumatology, Neurology and Nephrology. In addition, the Company has executed upon its previously discussed plans to modestly expand its sales force, and its Pulmonology sales force is now fully staffed and operational.<\/p>\n \nThis strong first-quarter performance is in line with expectations, and thus the Company is maintaining its 2023 revenue guidance for Cortrophin Gel of $80 million to $90 million, representing 92% – 116% year-over-year growth.<\/p>\n \nRare Disease remains a critical focus area for achieving future growth, and the Company continues to actively explore opportunities to acquire or establish partnerships to leverage its Rare Disease platform.<\/p>\n Generics Business, Established Brands and Others Update<\/span><\/p>\n \nSales of generic pharmaceuticals products grew 29.7% year-over-year in the first quarter of 2023 and increased 10% sequentially from a strong fourth quarter in 2022. The Company\u2019s generics business is well positioned for delivering sustainable growth driven by a strong R&D engine launching new products. Today, ANI retains a top ten ranking for new ANDA approvals and a number two ranking for Competitive Generic Therapy Approvals. In addition, ANI received multiple Abbreviated New Drug Applications (ANDAs) approvals, including Nitrofurantoin Oral Suspension USP, 25 mg\/5 ml and Colestipol Hydrochloride Tablets USP, 1 g.<\/p>\n \nANI\u2019s enhanced focus on operational excellence and U.S. based manufacturing sites have enabled the Company to capture numerous opportunities arising from supply disruptions in both generics and established brands. In addition, the Company augmented its strong GMP (Good Manufacturing Practices) track record with the successful conclusion of a U.S Food and Drug Administration (FDA) audit at its New Jersey site with zero 483s and No Actions Indicated (NAI) status.<\/p>\n \nAs previously announced, manufacturing operations ceased at the Oakville, Ontario, site in January 2023, with the successful relocation of the Oakville products to U.S. facilities. Discussions with potential buyers for the Oakville site are ongoing.<\/p>\n First Quarter 2023 Financial Results<\/i><\/b><\/p>\n
\nANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three months ended March 31, 2023.<\/p>\n\n
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