ANI Pharmaceuticals(ANIP) - 2025 Q3 - Quarterly Results

Financial Performance - Record quarterly net revenues of $227.8 million, an increase of 53.6% year-over-year[4] - Purified Cortrophin Gel net revenues of $101.9 million, an increase of 93.8% year-over-year[4] - Adjusted non-GAAP EBITDA of $59.6 million, an increase of 69.8% year-over-year[4] - Generics net revenues of $94.4 million, an increase of 20.6% year-over-year, driven by a successful partnered generic launch[8] - GAAP net income attributable to common shareholders of $26.3 million, or $1.13 per diluted share, compared to a net loss of $24.6 million in the prior year[17] - The company reported a net income of $26.6 million for Q3 2025, compared to a net loss of $24.2 million in Q3 2024[50] - Net income for the nine months ended September 30, 2025, was $50,847,000, compared to a loss of $(8,246,000) in the same period of 2024[56] - Adjusted non-GAAP net income available to common shareholders for the nine months ended September 30, 2025, was $112,643,000, compared to $70,024,000 in 2024, reflecting a 60% increase[58] Revenue Guidance - Total net revenue guidance for 2025 raised to $854 million to $873 million, representing a year-over-year growth of 39% to 42%[20] - Rare Disease net revenues expected to represent approximately 50% of total Company net revenues in 2025[4] - Cortrophin Gel net revenues guidance for 2025 set at $347 million to $352 million, indicating a growth of 75% to 78% year-over-year[20] - Adjusted non-GAAP diluted earnings per share guidance for 2025 raised to $7.37 to $7.64, reflecting a growth of 42% to 47% year-over-year[20] Cash and Assets - As of September 30, 2025, the Company had $262.6 million in unrestricted cash and cash equivalents[19] - Total current assets increased to $698,402 thousand as of September 30, 2025, up from $527,684 thousand on December 31, 2024, representing a 32.3% growth[52] - Cash and cash equivalents significantly increased to $262,610 thousand as of September 30, 2025, compared to $144,861 thousand on December 31, 2024, marking an 81.5% rise[52] - Accounts receivable, net, grew to $252,617 thousand as of September 30, 2025, from $221,726 thousand on December 31, 2024, a 13.9% increase[52] - Total stockholders' equity increased to $505,817 thousand as of September 30, 2025, up from $403,680 thousand on December 31, 2024, representing a 25.3% growth[52] Expenses - Non-GAAP research and development expenses for Q3 2025 were $12.3 million, up from $10.1 million in Q3 2024[50] - Non-GAAP selling, general, and administrative expenses for Q3 2025 were $76.7 million, slightly down from $79.1 million in Q3 2024[50] - Selling, general, and administrative expenses for the nine months ended September 30, 2025, were $241,041,000, up from $169,930,000 in 2024, a 42% increase[56] - Research and development expenses for the nine months ended September 30, 2025, totaled $234,955,000, compared to $179,917,000 in 2024, reflecting a 30% increase[56] - Stock-based compensation for the nine months ended September 30, 2025, was $28,161,000, compared to $22,283,000 in 2024, a 26% increase[58] - Litigation expenses for the nine months ended September 30, 2025, were $12,038,000, significantly higher than $4,738,000 in 2024, indicating a 154% increase[58] Operational Highlights - Operating income for the nine months ended September 30, 2025, was $76.3 million, compared to $5.0 million in the same period of 2024[50] - Adjusted non-GAAP EBITDA for the three months ended September 30, 2025, was $59,601 thousand, up from $35,104 thousand in 2024, reflecting a 69.9% increase[55] - Adjusted non-GAAP EBITDA for the nine months ended September 30, 2025, was $164,427,000, up from $105,961,000 in 2024, representing a 55% increase[56] - Adjusted diluted earnings per share for the nine months ended September 30, 2025, was $5.54, compared to $3.57 in 2024, indicating a 55% growth[58] Future Outlook - The company is focused on sustainable growth through its Rare Disease, Generics, and Brands business segments[43] - The company plans to continue focusing on market expansion and new product development to drive future growth[54] - The company did not provide a reconciliation for the forward-looking full year 2025 adjusted diluted earnings per share guidance due to insufficient information[35]