BioCryst Pharmaceuticals(BCRX) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights BioCryst reported record Q2 2025 financial performance, driven by ORLADEYO revenue and operating profit, with substantial debt paydown Q2 2025 Financial Highlights BioCryst achieved record Q2 2025 financial performance, driven by strong ORLADEYO net revenue and operating profit, with substantial debt paydown and retirement plans Q2 2025 Financial Highlights | Metric | Q2 2025 | YoY Change | | :-------------------------- | :---------- | :--------- | | ORLADEYO net revenue | $156.8 million | +45% | | Operating profit | $29.8 million | +239% | | Non-GAAP operating profit | $57.0 million | +160% | - 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[1] CEO Commentary CEO Jon Stonehouse highlighted record financial performance, strong ORLADEYO demand, accelerating operating profit, and a strengthened financial position - The financial performance this quarter is the best in the company's history, resulting from better-than-expected revenue growth and very meaningful operating profit[2] - ORLADEYO revenue and demand have never been stronger, driven by outstanding execution and increasing confidence in the product[2] - Accelerating operating profit and the sale of the European ORLADEYO business strengthen the financial position to deliver even greater value, with the pipeline on track for initial data later this year in two clinical programs[2] ORLADEYO Commercial Performance ORLADEYO achieved its strongest quarter yet for new patient prescriptions and revenue, driven by increasing demand and operational efficiencies Product Overview & Commercial Momentum ORLADEYO, an oral, once-daily treatment for Hereditary Angioedema (HAE) attacks, achieved its strongest quarter yet for new patient prescriptions and revenue in Q2 2025 - ORLADEYO (berotralstat) is an oral, once-daily treatment for the prevention of Hereditary Angioedema (HAE) attacks[3] - ORLADEYO continued its upward trajectory in the second quarter, delivering the strongest quarter yet for new patient prescriptions and revenue[4] - Growth was fueled by increasing demand in the U.S. and internationally, improved efficiency in getting paid shipments, fewer discontinuations, gross-to-net improvements, and continued impact of real-world evidence generation[4] Key Performance Indicators ORLADEYO net revenue grew 45% year-over-year to $156.8 million in Q2 2025, with record new patient prescriptions and lower discontinuations ORLADEYO Q2 2025 Key Performance Indicators | Metric | Q2 2025 Performance | | :------------------------------------ | :-------------------- | | Net Revenue | $156.8 million (+45% y-o-y) | | New Patient Prescriptions | Highest ever in a quarter (over 10% above Q1 launch) | | New U.S. Prescribers | 69 (up from 59 in Q1) | | U.S. Patient Discontinuations | Lower in H1 2025 vs H1 2024 | | U.S. Contribution to Global Net Revenues | 89.5% | - New real-world data from over 350 patients with HAE with normal C1 inhibitor showed substantial reductions in attack rates with ORLADEYO, reinforcing its value for a historically underserved patient segment[6] Pipeline & Corporate Updates BioCryst is advancing its rare disease pipeline, with key regulatory milestones and initial data expected for clinical programs, alongside strategic debt management Rare Disease Pipeline Strategy BioCryst aims to build on ORLADEYO's success by developing additional selected, highly differentiated products for patients with rare diseases - The company's goal is to build on its success with ORLADEYO by bringing additional selected, highly differentiated products to patients with rare diseases[5] Clinical Development Updates The company is advancing several pipeline programs, with a PDUFA goal date for ORLADEYO granules and initial Phase 1 data expected for BCX17725 and Avoralstat by year-end - The Prescription Drug User Fee Act goal date for the company's new drug application for ORLADEYO granules in children with HAE aged 2 to 11 is December 12, 2025, which would make ORLADEYO the first targeted oral prophylactic therapy for children with HAE[14] - BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, is enrolling a Phase 1 trial in healthy volunteers and patients, with initial data expected by year-end[14] - Avoralstat, an investigational plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME), is enrolling a Phase 1 trial in patients, with initial data expected by year-end[14] Debt Management & European Business Sale BioCryst made an additional $50 million paydown on its Pharmakon term loan in July and plans to retire all remaining term debt upon the expected closing of its European business sale - In July, the company paid down an additional $50 million on the outstanding principal amount under the Pharmakon term loan, leaving a remaining principal balance of $199 million[14] - Upon the expected closing of the sale of its European business in early October, the company intends to retire all its remaining term debt[15] Second Quarter 2025 Financial Results (GAAP) BioCryst reported strong Q2 2025 GAAP financial results, with significant revenue growth, increased operating income, and a swing to net income Total Revenues Total revenues for Q2 2025 increased 50% year-over-year to $163.4 million, primarily driven by a 45% increase in ORLADEYO net revenue Total Revenues (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change | | :------------- | :-------------------- | :-------------------- | :--------- | | Total Revenues | $163.4 | $109.3 | +50% | | ORLADEYO Net Revenue | $156.8 | $108.3 | +45% | Operating Expenses (R&D, SG&A) Research and development expenses increased 15% to $43.4 million, while selling, general and administrative expenses rose 43% to $87.4 million, driven by deal-related costs and reclassifications Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change | | :--------------- | :-------------------- | :-------------------- | :--------- | | R&D Expenses | $43.4 | $37.6 | +15% | | SG&A Expenses | $87.4 | $61.2 | +43% | - R&D increase primarily due to preclinical and early clinical work for avoralstat and BCX17725, investigational new drug application-enabling activities for early phase pipeline programs, and stock-based compensation, partially offset by discontinuation of Factor D programs and reclassification of ORLADEYO-related expenses[8] - SG&A increase driven by approximately $10.7 million in deal-related costs and stock-based compensation, and approximately $6.5 million from reclassified ORLADEYO-related regulatory, safety, quality, and manufacturing expenses[9] Operating Income & Net Income GAAP operating income significantly increased to $29.8 million in Q2 2025, resulting in a net income of $5.1 million ($0.02 per share), a substantial improvement from a net loss in Q2 2024 Operating and Net Income (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change | | :-------------------- | :-------------------- | :-------------------- | :--------- | | Operating Income | $29.8 | $8.8 | +239% | | Net Income (Loss) | $5.1 | $(12.7) | N/A (swing to profit) | | EPS (basic) | $0.02 | $(0.06) | N/A (swing to profit) | Interest Expense Interest expense decreased 13% year-over-year to $21.6 million in Q2 2025, primarily due to a partial prepayment on the Pharmakon Term Loan and a decrease in the effective interest rate Interest Expense (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change | | :------------- | :-------------------- | :-------------------- | :--------- | | Interest Expense | $21.6 | $24.7 | -13% | - The decrease was primarily the result of the $75 million partial prepayment on the outstanding principal amount under the Pharmakon Term Loan in April