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]

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](index=1&type=section&id=Q2%202025%20Financial%20Highlights) 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](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) 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](index=2&type=chunk) - ORLADEYO revenue and demand have never been stronger, driven by outstanding execution and increasing confidence in the product[2](index=2&type=chunk) - 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](index=2&type=chunk) 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](index=1&type=section&id=Product%20Overview%20%26%20Commercial%20Momentum) 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](index=3&type=chunk) - ORLADEYO continued its upward trajectory in the second quarter, delivering the strongest quarter yet for new patient prescriptions and revenue[4](index=4&type=chunk) - 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](index=4&type=chunk) [Key Performance Indicators](index=1&type=section&id=Key%20Performance%20Indicators) 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](index=6&type=chunk) 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](index=1&type=section&id=Rare%20Disease%20Pipeline%20Strategy) 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](index=5&type=chunk) [Clinical Development Updates](index=2&type=section&id=Clinical%20Development%20Updates) 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) [Debt Management & European Business Sale](index=2&type=section&id=Debt%20Management%20%26%20European%20Business%20Sale) 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](index=14&type=chunk) - 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](index=15&type=chunk) 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](index=2&type=section&id=Total%20Revenues) 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)](index=2&type=section&id=Operating%20Expenses%20(R%26D%2C%20SG%26A)) 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](index=8&type=chunk) - 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](index=9&type=chunk) [Operating Income & Net Income](index=2&type=section&id=Operating%20Income%20%26%20Net%20Income) 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](index=2&type=section&id=Interest%20Expense) 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

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 (BCRX) is expected to report its Q2 2025 results on August 4, with revenue estimates of $148.85 million and earnings per share (EPS) of 3 cents [1][7] - The Zacks Consensus Estimate for BCRX's 2025 EPS has decreased from 16 cents to 13 cents over the past 60 days, while the 2026 EPS forecast has improved from 44 cents to 48 cents [2] Financial Performance - BCRX has shown mixed performance in the last four quarters, with two earnings beats, one match, and one miss, averaging an earnings surprise of 12.94% [5][6] - The last reported quarter saw a 100% earnings surprise [5] Upcoming Earnings Expectations - The company is likely to see increased sales from Orladeyo due to strong prescription trends, while SG&A costs are expected to rise due to global launch activities [7][10] - R&D expenses are anticipated to decline due to pipeline restructuring [13] Product and Pipeline Updates - Orladeyo is approved for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older, with a label expansion application for younger patients currently under FDA review [10][11] - The FDA has cleared the investigational new drug application for BCX17725, targeting Netherton syndrome, with patient enrollment expected to begin soon [12] Market Position and Competition - BCRX has gained 9.3% year-to-date, outperforming the industry and S&P 500, but is trading below its 50 and 200-day moving averages [14] - The company faces competition from Ionis Pharmaceuticals and Intellia Therapeutics in the HAE treatment space, as well as from other companies in the Netherton syndrome indication [22][23] Strategic Focus - BioCryst aims to expand Orladeyo's market presence through increased global commercial activities and is looking to diversify its pipeline for other rare diseases [24]

Core Viewpoint - BioCryst Pharmaceuticals announces the retirement of CEO Jon Stonehouse, effective December 31, 2025, with Charlie Gayer appointed as the new CEO starting January 1, 2026, following his role as Chief Commercial Officer [1][2][4] Company Leadership Transition - Jon Stonehouse will remain on the board of directors after his retirement [2] - Charlie Gayer has been instrumental in the successful launch of ORLADEYO (berotralstat), which is projected to achieve peak sales of $1 billion [3][4] Strategic Direction and Achievements - Under Stonehouse's leadership, BioCryst has become a profitable company with a strong future, focusing on delivering life-changing therapies [4] - Gayer's promotion reflects the company's succession planning, emphasizing his proven track record and ability to enhance the company's mission [4] Background of New CEO - Charlie Gayer joined BioCryst in 2015 and became CCO in January 2020, previously holding leadership roles in rare disease categories at Talecris Biotherapeutics and Grifols [5] - Gayer has a strong educational background with a B.A. from Princeton University and an M.B.A. from Duke University [5] Company Overview - BioCryst Pharmaceuticals is dedicated to improving the lives of patients with hereditary angioedema and other rare diseases, focusing on developing innovative oral small-molecule and protein therapeutics [6]

Core Viewpoint - BioCryst Pharmaceuticals (BCRX) is anticipated to report a year-over-year increase in earnings and revenues for the quarter ended June 2025, with the actual results having a significant impact on its near-term stock price [1][2]. Financial Expectations - The upcoming earnings report is expected to show quarterly earnings of $0.03 per share, reflecting a year-over-year increase of 150% [3]. - Revenues are projected to be $148.85 million, which is a 36.2% increase from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating that analysts have not significantly reassessed their initial estimates [4]. - For BioCryst, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -66.67%, suggesting a bearish outlook from analysts [11]. Earnings Surprise History - In the last reported quarter, BioCryst was expected to post a loss of $0.07 per share but instead delivered break-even earnings, resulting in a surprise of +100.00% [12]. - Over the past four quarters, the company has beaten consensus EPS estimates two times [13]. Industry Comparison - In the Zacks Medical - Drugs industry, Indivior PLC (INDV) is expected to report earnings of $0.26 per share for the same quarter, indicating a year-over-year decline of 40.9% [17]. - Indivior's revenue is projected to be $244.27 million, down 18.3% from the previous year, but it has an Earnings ESP of +11.54%, suggesting a likelihood of beating the consensus EPS estimate [18][19].

Core Viewpoint - BioCryst Pharmaceuticals, Inc. will report its second quarter 2025 financial results on August 4, 2025, and will host a conference call to discuss these results and provide a corporate update [1]. Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of individuals with hereditary angioedema and other rare diseases [3]. - The company specializes in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics targeting difficult-to-treat diseases [3]. - BioCryst has commercialized ORLADEYO (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies [3]. Conference Call Details - The conference call will take place at 8:30 a.m. ET on August 4, 2025, and will be accessible via phone and webcast [1][2]. - Domestic callers can dial 1-844-481-2942, while international callers can reach the call at 1-412-317-1866 [2]. - A live webcast and replay will be available in the investors section of the company website [2].

Core Insights - BioCryst Pharmaceuticals will present new findings on the burden of current treatments for hereditary angioedema (HAE) on pediatric patients under 12 and their caregivers at the 2025 US HAEA National Summit [1][2] - The company emphasizes its commitment to the HAE patient community and its efforts to develop effective treatments, including the first oral, once-daily prophylactic therapy for HAE [2] Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of individuals with hereditary angioedema and other rare diseases [12] - The company has commercialized ORLADEYO (berotralstat), the first oral plasma kallikrein inhibitor for HAE, and is advancing a pipeline of small-molecule and protein therapies [12] Product Information - ORLADEYO is indicated for the prophylaxis of HAE attacks in adults and pediatric patients aged 12 years and older [5] - The product works by decreasing the activity of plasma kallikrein, preventing HAE attacks with a once-daily capsule [4] Research Presentation - BioCryst will present three abstracts at the summit, focusing on patient perspectives, treatment burdens for pediatric patients, and interim analysis results of prophylactic berotralstat in pediatric patients aged 2 to under 12 years [3][10]

Company Overview - BioCryst Pharmaceuticals (BCRX) is part of the Medical group, which consists of 987 companies and is currently ranked 6 in the Zacks Sector Rank [2] - The Zacks Rank system identifies stocks with characteristics likely to outperform the market in the short term, with BioCryst Pharmaceuticals holding a Zacks Rank of 2 (Buy) [3] Performance Metrics - Over the past 90 days, the Zacks Consensus Estimate for BCRX's full-year earnings has increased by 324.2%, indicating improved analyst sentiment and a positive earnings outlook [4] - Year-to-date, BCRX has returned 18.9%, significantly outperforming the average return of -3.1% for Medical companies [4] - BioCryst Pharmaceuticals belongs to the Medical - Drugs industry, which includes 155 companies and is currently ranked 67 in the Zacks Industry Rank, with an average gain of 3.5% year-to-date [6] Comparative Analysis - Another outperforming stock in the Medical sector is Cardinal Health (CAH), which has increased by 39.5% year-to-date and has a Zacks Rank of 2 (Buy) [5] - Cardinal Health is part of the Medical - Dental Supplies industry, which has a current ranking of 27 and has seen a year-to-date increase of 0.7% [7]

Core Insights - BioCryst Pharmaceuticals has appointed Babar Ghias as the new Chief Financial Officer (CFO) and head of corporate development, bringing extensive experience in deal-making and operational management [1][2] - Ghias has a strong background in the biotech sector, having previously served as CFO at AvenCell Therapeutics and held senior roles at Paragon Biosciences and Marathon Pharmaceuticals, where he raised over $1 billion in capital [3][4][5] - The company aims to leverage Ghias's expertise to accelerate growth and enhance value, particularly through the commercial momentum of its product ORLADEYO and its advancing pipeline [6][8] Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on developing therapies for rare diseases, particularly hereditary angioedema [8] - The company has commercialized ORLADEYO (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies [8]