BioCryst Pharmaceuticals(BCRX) - 2025 Q1 - Quarterly Report

Financial Performance - Revenues for Q1 2025 were $145,534, a 57% increase compared to $92,761 in Q1 2024[22] - Net income for Q1 2025 was $32, compared to a net loss of $35,379 in Q1 2024[22] - Total revenues for the three months ended March 31, 2025, were $145,534,000, a 57% increase from $92,761,000 in the same period of 2024[37] - Net product sales for ORLADEYO amounted to $143,787,000 for the three months ended March 31, 2025, compared to $89,272,000 in the prior year, reflecting a 61% growth[37] - The Company recorded a segment net income of $32,000 for Q1 2025, a significant recovery from a net loss of $35,379,000 in Q1 2024[178] - Total revenues for the three months ended March 31, 2025, were $145.5 million, up from $92.8 million for the same period in 2024, driven by a $45.4 million increase in ORLADEYO net revenue[212] Expenses - Research and development expenses decreased to $37,270 from $46,493 in Q1 2024, a reduction of approximately 20%[22] - Selling, general and administrative expenses increased to $82,469 from $59,491, a rise of approximately 38%[22] - The Company incurred $82,469,000 in selling, general and administrative expenses for Q1 2025, up from $59,491,000 in Q1 2024[178] - Stock-based compensation expense increased from $13,652,000 in Q1 2024 to $21,368,000 in Q1 2025, an increase of about 56.7%[152] - Selling, general and administrative expenses for Q1 2025 were $82.5 million, up from $59.5 million in Q1 2024, reflecting increased commercial expenses and stock-based compensation[217] Assets and Liabilities - Total current assets decreased to $409,977 from $421,968 as of December 31, 2024[21] - Total liabilities decreased to $931,974 from $966,354 as of December 31, 2024[21] - Cash and cash equivalents increased to $105,190 from $104,713 as of December 31, 2024[21] - The Company reported a total stockholders' deficit of $451,927 as of March 31, 2025, improved from $475,934 as of December 31, 2024[21] - The Company had investments with a total estimated fair value of $210,450,000 as of March 31, 2025, down from $236,460,000 at December 31, 2024[110] Revenue Recognition and Receivables - Trade receivables are primarily due from specialty pharmacy customers in the U.S. and third-party distributors, with standard payment terms of 30 to 90 days[58] - The Company recognizes revenue from license fees and royalties when the earnings process is complete, with royalties based on licensees' net sales of covered products[48][50] - The Company evaluates trade receivables for estimated losses and provides reserves based on current economic conditions and historical collection experience[60] - The Company recorded approximately 84% and 87% of total net revenues from sales of ORLADEYO through a single specialty pharmacy for the three months ended March 31, 2025 and 2024, respectively[94] Inventory and Production - The Company’s inventory primarily consists of ORLADEYO and peramivir, valued at the lower of cost or estimated net realizable value[61] - Total inventory as of March 31, 2025, was $31,970,000, slightly up from $31,274,000 at December 31, 2024[115] - The Company expenses costs related to production of pre-launch inventory as research and development expense until regulatory approval is received, after which inventory costs are capitalized[64] - The Company has significant judgment in determining the need for valuation reserves for inventory, which includes excess, obsolete, or unmarketable inventory[63] Debt and Financing - The Company has entered into royalty purchase agreements with RPI and OMERS, totaling $275,000,000 in cash for future royalty payments[116] - As of March 31, 2025, the carrying value of royalty financing obligations was approximately $500,918, with effective interest rates of 21.6% for the 2020 RPI Agreement and 10.0% for the OMERS Agreement[127] - The Company had total borrowings of $300,000 under the Pharmakon Loan Agreement as of March 31, 2025, with interest expense of $9,153 for the quarter[138] - The Pharmakon Loan Agreement allows for quarterly interest-only payments until the maturity date of April 17, 2028, with an effective interest rate of 12.31% for the three months ended March 31, 2025[134] - The Company incurred debt fees and issuance costs of $11,147 associated with the Tranche A Loan, which are being amortized over the term of the loan[141] Clinical Development and Regulatory - The FDA has cleared the investigational new drug application for BCX17725, enabling clinical trials to enroll patients in the United States[209] - The company expects to submit a new drug application to the FDA in 2025 to expand the ORLADEYO label to children aged 2 to 11[206] - The ongoing APeX-P clinical trial is assessing an oral granule formulation of ORLADEYO in pediatric patients aged 2 to 11[189] - The Company anticipates initial clinical data from the avoralstat program targeted by the end of 2025[210] Market and Competitive Landscape - The Company is seeking to defend its intellectual property rights against Annora Pharma's ANDA filing for a generic version of ORLADEYO, which could impact future revenues[179] - ORLADEYO is projected to reach a global peak of $1 billion in annual net revenues, with approximately 80% expected from the United States[190] - The percentage of U.S. HAE patients preferring an oral prophylaxis therapy increased to 70% in 2025, up from 50% in 2023[207]