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ANI Pharmaceuticals Inc (ANIP) Reports Record Q3 2023 Results; Raises Full-Year Guidance

  • ANI Pharmaceuticals Inc (NASDAQ:ANIP) announces record third-quarter net revenues of $131.8 million, a 57.3% increase year-over-year.

  • Adjusted non-GAAP EBITDA soared to $36.5 million, marking a 98.3% growth compared to Q3 2022.

  • Full-year 2023 guidance raised, with net revenue now expected to be between $468 million and $478 million.

  • Cortrophin Gel sales surge, prompting a specific revenue guidance increase to $100 million to $107 million.

ANI Pharmaceuticals Inc (NASDAQ:ANIP) released its financial results for the third quarter ended September 30, 2023, showcasing a period of significant growth and operational success. The company reported a record quarterly net revenue of $131.8 million, representing a substantial 57.3% increase from the same period last year. This growth was propelled by a 135.9% increase in net sales of its lead Rare Disease asset, Cortrophin Gel, which contributed $29.7 million to the top line. The Generics, Established Brands, and Other segments also reported robust growth, with net sales of $102.1 million, up 43.4% year-over-year.

Financial Performance Highlights

ANI Pharmaceuticals Inc (NASDAQ:ANIP) achieved a GAAP net income available to common shareholders of $9.5 million, with diluted GAAP income per share at $0.45. The adjusted non-GAAP EBITDA reached a record $36.5 million, nearly doubling from $18.4 million in Q3 2022. Adjusted non-GAAP diluted earnings per share stood at $1.27, more than doubling the $0.58 reported in the same quarter of the previous year. The company ended the quarter with a strong liquidity position, having $193.1 million in cash and cash equivalents.

Operational and Business Highlights

ANI Pharmaceuticals Inc (NASDAQ:ANIP) experienced continued momentum for Cortrophin Gel, with a record number of new patient starts and cases initiated. The company also saw an increase in new unique prescribers, including those naive to ACTH therapy. The Generics and Established Brands businesses capitalized on pharmaceutical shortages due to supply chain disruptions, demonstrating the company's operational excellence and U.S.-based manufacturing capabilities. ANI's R&D organization contributed to this success with five new product launches and the filing of three new ANDAs and two new 505(b)(2) applications during the quarter.

Revised Full-Year 2023 Guidance

Based on the strong performance, ANI Pharmaceuticals Inc (NASDAQ:ANIP) has raised its full-year 2023 guidance. The company now expects net revenue to be between $468 million and $478 million, adjusted non-GAAP EBITDA to range from $128 million to $133 million, and adjusted non-GAAP earnings per share to be between $4.29 and $4.57. The midpoint of the revised total company guidance represents a 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%.

Management Commentary

ANI's President and CEO, Nikhil Lalwani, commented on the results, stating,

Strong execution has resulted in another record quarter for revenue and adjusted non-GAAP EBITDA, positioning us to raise full-year 2023 guidance for the third consecutive quarter."

Lalwani also highlighted the company's commitment to growing its Rare Disease portfolio and leveraging financial results and cash flow for targeted M&A and in-licensing opportunities.

ANI Pharmaceuticals Inc (NASDAQ:ANIP) has demonstrated a robust financial performance in Q3 2023, with significant growth in revenue and profitability. The company's upward revision of its full-year 2023 guidance reflects confidence in its continued success and strategic initiatives. For detailed financial tables and further information, please refer to the full earnings report.

For more in-depth analysis and up-to-date financial news, visit GuruFocus.com.

Explore the complete 8-K earnings release (here) from ANI Pharmaceuticals Inc for further details.

This article first appeared on GuruFocus.

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