BioCryst Pharmaceuticals (NasdaqGS:BCRX) M&A Announcement October 14, 2025 08:00 AM ET Speaker1Good day and welcome to the BioCryst Pharmaceuticals conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touchtone phone. To withdraw your questions, please press star ...

Acquisition Overview - BioCryst is set to acquire Astria for approximately $700 million in total enterprise value [14, 37] - Astria stockholders are expected to own 15% of the pro forma equity [37] - The transaction is expected to close in Q1 2026 [38] Strategic Rationale - The acquisition expands and strengthens BioCryst's presence in the HAE market [14] - It is expected to transform BioCryst's revenue profile through the next decade, with double-digit portfolio CAGR [14] - The acquisition reinforces operational and financial excellence with continued profitability (non-GAAP) and cash flow generation expected [39] Navenibart Potential - Navenibart, Astria's late-stage asset, has the potential to be a best-in-class injectable prophylactic therapy for HAE [14, 39] - Phase 1b/2 data indicates potential for best-in-class efficacy with a favorable safety profile, and infrequent 3-to-6-month dosing [14, 17] - Navenibart could address a market of 5,000+ patients in the US [22] Financial Impact - BioCryst expects to remain profitable (non-GAAP) and cash flow positive post-transaction [14, 37] - The transaction is expected to be significantly accretive to operating profit (non-GAAP) in the first full year of launch [37] - BioCryst anticipates a cash balance of over $1 billion by 2029 [14, 35]

Financial Performance & Guidance - BioCryst's Q2 2025 was strong, driven by increased ORLADEYO demand[14] - ORLADEYO revenue is expected to meet the previous guidance range of $580-600 million for FY25, even excluding Q4 2025 EU revenue[16] - The company anticipates achieving full-year operating profit in 2026 and positive net income & cash flows in 2026+[58] - Cash, cash equivalents, restricted cash & investments totaled $287 million as of June 30, 2025[63] - The company paid down $50 million of its senior credit facility in July 2025[62] ORLADEYO & Market Dynamics - Market research indicates a growing patient preference for oral administration of HAE long-term prophylaxis (LTP) since 2023[17] - Monte Carlo simulation projects ORLADEYO reaching a steady state of over 2,000 patients in the US by 2028[25] - ORLADEYO revenue advances to royalty-free tier (>$550M)[61] - The blended royalty rate for ORLADEYO is expected to decline to approximately 4% at peak sales once OMERS reaches its cap[67] Pipeline Development - The PDUFA target date for the pediatric NDA for ORLADEYO is December 12, 2025[32] - An IND has been cleared by the FDA for BCX17725, a targeted KLK5 inhibitor for treating Netherton syndrome (NS)[37]

Core Insights - BioCryst Pharmaceuticals reported its strongest quarterly results to date, achieving its first significant profit on a GAAP basis with revenues and earnings exceeding Wall Street expectations [1][5] - The company experienced a notable shift from prior-year losses to profit, driven by surging demand for its key product, ORLADEYO [1][6] Financial Performance - GAAP revenue reached $163.4 million, a 49.5% increase from $109.3 million in Q2 2024, surpassing the analyst consensus of $149.8 million by $13.6 million [2][5] - Non-GAAP earnings per share rose to $0.15, significantly higher than the estimated $0.01 and up from $0.00 in Q2 2024 [2] - ORLADEYO revenue was $156.8 million, reflecting a 45% year-over-year growth from $108.3 million [2][5] - GAAP net income was $5.1 million, a turnaround from a GAAP net loss of $12.7 million in Q2 2024 [2][6] Business Strategy and Operations - The company is focused on expanding ORLADEYO's market reach and advancing pipeline candidates through early clinical trials [4] - Strong commercialization efforts in the U.S. contributed to a record number of new prescribers, reaching 69, up from 59 in Q1 2025 [5] - The paid prescription rate for ORLADEYO increased to approximately 84%, indicating improved conversion rates from free-to-paid prescriptions [5] Debt Management and Financial Health - BioCryst prepaid $75 million of its term debt and an additional $50 million after the reporting period, reducing the outstanding balance to $199 million [7] - Cash, cash equivalents, and investments totaled $287.1 million as of June 30, 2025, providing a solid foundation for future investments and debt reduction [7] Product Pipeline and Future Prospects - The pediatric formulation of ORLADEYO is under FDA review, with a decision expected on December 12, 2025 [8] - Ongoing early-stage trials for BCX17725 and Avoralstat target underserved patient groups, with initial data readouts anticipated by year-end [9] - The planned divestiture of the European ORLADEYO business is expected to be finalized by Q4 2025, allowing for the full retirement of remaining term debt [10] Guidance and Market Outlook - BioCryst reaffirmed its full-year 2025 guidance for ORLADEYO revenue, targeting $580 million to $600 million, reflecting confidence in U.S. and international market growth [11] - Operating expenses are projected to be between $440 million and $450 million for full-year 2025, consistent with prior guidance [11] - Key areas for future monitoring include the commercial performance of ORLADEYO, sustainability of paid prescription rates, and progress of clinical pipeline assets [12]

Core Insights - BioCryst Pharmaceuticals reported its strongest financial performance in history for Q2 2025, driven by significant revenue growth and operating profit from ORLADEYO [2][6][7] Financial Performance - ORLADEYO net revenue reached $156.8 million, reflecting a 45% year-over-year increase [6][7] - Total revenues for Q2 2025 were $163.4 million, up 50% from $109.3 million in Q2 2024 [7] - Operating profit for Q2 2025 was $29.8 million, a 239% increase year-over-year, while non-GAAP operating profit was $57.0 million, up 160% [10] Market Dynamics - New patient prescriptions for ORLADEYO were the highest ever in a quarter, exceeding the first quarter of the launch by over 10% [6][4] - The U.S. market contributed 89.5% of global ORLADEYO net revenues in Q2 2025 [6] Debt Management - The company made an additional $50 million paydown of term debt and plans to retire all remaining term debt with proceeds from the sale of its European ORLADEYO business [14] Pipeline Development - BioCryst is on track to submit a new drug application for ORLADEYO granules for children aged 2 to 11 by December 12, 2025 [5] - The company expects initial data from two clinical programs by the end of 2025 [2][15] Cash Flow and Outlook - Cash, cash equivalents, and investments totaled $287.1 million as of June 30, 2025, with net cash utilization of $30.4 million for the quarter [13] - The company maintains its full-year 2025 global net ORLADEYO revenue guidance between $580 million and $600 million, excluding European revenue [15][16]

Core Insights - BioCryst Pharmaceuticals reported a strong Q1 2025 performance with ORLADEYO net revenue of $134.2 million, reflecting a 51% year-over-year increase [1][6] - The company has raised its full-year 2025 revenue guidance for ORLADEYO to between $580 million and $600 million, up from previous estimates [1][15] - BioCryst anticipates achieving profitability for the full year 2025, a year earlier than previously expected [1][16] Financial Performance - Total revenues for Q1 2025 reached $145.5 million, a 56.8% increase from $92.8 million in Q1 2024 [8] - Research and development expenses decreased to $37.3 million, down 19.8% from $46.5 million in Q1 2024 [9] - Selling, general and administrative expenses rose to $82.5 million, a 38.7% increase compared to $59.5 million in Q1 2024 [10] - Operating income for Q1 2025 was $21.2 million, compared to an operating loss of $14.5 million in Q1 2024 [11] Debt Management - The company paid down $75 million of its debt early in Q2 2025, which is expected to save approximately $23.5 million in interest over the loan's life [1][14] Product Development - BioCryst submitted a new drug application (NDA) for ORLADEYO oral granules for children aged 2-11 with hereditary angioedema (HAE) [1][5] - The company is progressing with clinical trials for BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema (DME) [7][11] Market Dynamics - The percentage of ORLADEYO patients on paid drug increased to approximately 84%, up from 73.5% at the end of 2024, indicating strong market demand [6][4] - A recent survey indicated that 70% of U.S. HAE patients prefer oral prophylaxis therapy, up from 50% in 2023 [6]