Core Insights - BioCryst Pharmaceuticals reported first-quarter sales of $145.50 million, a 52.7% increase year over year, surpassing the consensus estimate of $126.87 million [1] - The growth was primarily driven by Orladeyo's net revenue of $134.2 million, which increased by $45.3 million year over year, compared to $88.9 million in the same quarter of the previous year [1] Financial Performance - The net income for the first quarter of 2025 was $32 thousand, or $0.00 per share, a significant improvement from a net loss of $35.4 million, or $0.17 per share, in the first quarter of 2024 [2] - Operating income for the first quarter of 2025 was $21.2 million, compared to an operating loss of $14.5 million for the same period in 2024 [3] - Non-GAAP operating income, excluding stock-based compensation, was $42.6 million for the first quarter of 2025, compared to a non-GAAP operating loss of $0.8 million in the first quarter of 2024 [3] Guidance and Outlook - BioCryst raised its 2025 revenue outlook for Orladeyo to between $580 million and $600 million, up from the previous estimate of $535 million to $550 million [4] - The company now anticipates full-year 2025 operating expenses to be between $440 million and $450 million, an increase from the prior guidance of $425 million to $435 million [4] - The expectation for achieving net income and positive cash flows has been accelerated to 2025, previously anticipated for 2026 [5] - Positive cash flow is defined as the improvement in cash and equivalents from year-end 2024 to year-end 2025, excluding a $75 million prepayment made in April 2025 [5] Market Reaction - Following the announcement, BCRX stock closed up by 23.50% to $11.03 [5]

Group 1 - The article emphasizes that investing is a learning process, where failures serve as tuition and successes contribute to lessons learned [1] - The author has approximately five years of focused research on various stocks, particularly in the healthcare sector [1] Group 2 - There is no current stock or derivative position in any mentioned companies, but there is a potential for initiating a long position within the next 72 hours [2] - The article reflects the author's personal opinions and is not influenced by compensation from any company mentioned [2]

Financial Data and Key Metrics Changes - The company reported quarterly revenue of $145.5 million, with $134 million coming from Orlodayo, marking a significant increase from previous quarters [6][27] - Annual revenue guidance for Orlodayo has been raised to between $580 million and $600 million, reflecting a growth of 33% to 37% over the previous year [7][28] - Operating profit for Q1 2025 was $21.2 million, with net income slightly positive, and cash at the end of the quarter was $317 million [28][30] Business Line Data and Key Metrics Changes - The U.S. commercial team has successfully transitioned patients from free drug to paid status, achieving an 84% paid rate among commercial insurance patients, up from 73.5% [12][27] - The paid patient rate increased by 10 percentage points in Q1, with two-thirds of this improvement attributed to the Inflation Reduction Act [11][57] - The gross to net ratio improved, with expectations to maintain an average of around 15% for the full year [14][28] Market Data and Key Metrics Changes - The demand for Orlodayo has remained strong, with new prescriptions slightly exceeding the best quarter from the previous year [9][62] - The company anticipates capturing more revenue opportunities as the patient base continues to grow, aiming for $1 billion in global revenue by 2029 [13][62] Company Strategy and Development Direction - The company is focused on advancing its pipeline and has submitted a pediatric NDA for Orlodayo, aiming to introduce an oral granule formulation for patients aged 2 to 11 [16][30] - The company is also progressing with clinical trials for new treatments targeting Netherton syndrome and diabetic macular edema, with initial data expected by the end of the year [17][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial strength and ability to achieve profitability this year, one year earlier than previously planned [7][30] - The management highlighted the importance of sustainable revenue growth and the ability to pay down debt while investing in the pipeline [8][30] Other Important Information - The company paid down $75 million of its debt in April, reducing outstanding debt to $249 million, which is expected to save approximately $23 million in interest payments over the life of the debt [28][30] - The company is well-positioned in a competitive market, with a focus on providing effective treatments for underserved patient populations [30] Q&A Session Summary Question: What is the potential for pediatric patients on TAKHZYRO? - Management estimates around 500 pediatric patients on TAKHZYRO in the U.S., with at least 200 potentially appropriate for prophylactic therapy [34][35] Question: What factors contributed to the increase in paid patients? - The increase in paid patients was primarily due to improved Medicare coverage and better execution in the commercial segment [46][57] Question: What benchmarks are being looked for in the DME program? - The company is looking for a clear reduction in retinal edema and thickness as a benchmark for moving forward with the DME program [92][93] Question: How does the company plan to handle the pediatric launch? - The company aims to minimize the lag in deployment upon approval and is preparing to promote the pediatric formulation immediately [100][101] Question: What is the expected dosing range for the new treatment? - The initial dosing for the new treatment will be around six milligrams, with adjustments based on patient response [105][106]

Core Insights - BioCryst Pharmaceuticals (BCRX) reported break-even quarterly earnings per share, surpassing the Zacks Consensus Estimate of a loss of $0.07, and showing improvement from a loss of $0.17 per share a year ago, resulting in an earnings surprise of 100% [1] - The company posted revenues of $145.53 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 14.97%, and up from $92.76 million year-over-year [2] - BioCryst shares have increased approximately 18.8% since the beginning of the year, contrasting with a -3.3% decline in the S&P 500 [3] Earnings Outlook - The future performance of BioCryst's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - Current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $137.38 million, and for the current fiscal year, it is -$0.09 on revenues of $565.22 million [7] Industry Context - The Medical - Drugs industry, to which BioCryst belongs, is currently ranked in the top 25% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, ProPhase Labs, Inc. (PRPH), is expected to report a quarterly loss of $0.18 per share, reflecting a year-over-year change of -157.1% [9]

Financial Data and Key Metrics Changes - The company reported quarterly revenue of $145.5 million, with $134 million attributed to Orlodayo, marking a significant increase from the previous year [6][28] - Annual revenue guidance for Orlodayo has been raised to between $580 million and $600 million, reflecting a growth of 33% to 37% over last year [6][29] - Operating profit for Q1 2025 was $21.2 million, with net income reported as slightly positive [29] - Cash at the end of the quarter stood at $317 million, and the company reduced its outstanding debt by $75 million, bringing it down to $249 million [28][30] Business Line Data and Key Metrics Changes - The U.S. commercial team successfully transitioned patients from free drug to paid status, achieving a 10 percentage point increase in the paid patient rate, now at 84% [10][12] - The paid rate among Medicare patients improved significantly, with 89% now receiving paid therapy [93] - The gross to net ratio improved, with expectations to maintain it around 15% for the full year [14][51] Market Data and Key Metrics Changes - The company noted a strong demand for Orlodayo, with new prescriptions slightly exceeding the best quarter from the previous year [8][10] - The percentage of U.S. patients who strongly prefer oral prophylaxis increased to 70%, up from 51% in 2023 [10] - The company anticipates reaching $1 billion in global revenue by 2029, with a more profitable path than previously expected [13][64] Company Strategy and Development Direction - The company is focusing on expanding its pipeline, with significant milestones achieved, including the submission of a pediatric NDA for Orlodayo [16] - The company aims to capture more revenue from Orlodayo as the patient base continues to grow, with a long-term goal of 85% paid therapy [12][13] - The company is committed to disciplined capital allocation to create sustainable long-term revenue growth while reducing debt [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of the paid rate improvement, viewing 84% as a new floor for future performance [118] - The company is optimistic about the impact of the Inflation Reduction Act on patient affordability and access to Orlodayo [11][57] - Management highlighted the importance of real-world evidence in convincing payers of the drug's efficacy, which has improved payer conversations [94] Other Important Information - The company is preparing for the launch of a pediatric formulation of Orlodayo, with expectations for rapid deployment following approval [106] - The company is also advancing its clinical pipeline, with a focus on rare diseases and the potential for transformative treatments [16][18] Q&A Session Summary Question: What is the potential impact of the pediatric launch on Orlodayo? - Management expects the pediatric launch to be a significant tailwind, with around 500 pediatric patients in the U.S. potentially appropriate for prophylactic therapy [35][36] Question: Can you elaborate on the improvements in getting patients onto paid drug? - The team made investments in the reauthorization process and improved their execution, leading to a higher paid rate [46][47] Question: What benchmarks are being set for the DME program? - The company is looking for a clear reduction in retinal edema as a benchmark for moving forward with the DME program [41][97] Question: How sustainable is the paid rate improvement? - Management believes the paid rate improvement is sustainable, with 84% being a new baseline for future performance [118] Question: What is the expected timeline for the pediatric formulation launch? - The company aims to minimize the lag time between approval and market availability, similar to previous launches [106][107]

First Quarter 2025 Results Call Corporate Update & Financial Results May 5, 2025 CONFIDENTIAL & PROPRIETARY Forward-looking statements President and Chief Executive Officer ORLADEYO® update Charlie Gayer Chief Commercial Officer BioCryst's presentation contains forward-looking statements, including, but not limited to, statements regarding future results and forward-looking financial information, company performance, achievements, future market share or size, and expectations regarding pipeline development. ...

EXHIBIT 99.1 BioCryst Reports First Quarter 2025 Financial Results and Provides Business Update —Q1 2025 ORLADEYO net revenue of $134.2 million (+51 percent y-o-y)— —Full year 2025 ORLADEYO revenue guidance increased to $580 million to $600 million— —Company now expects to be profitable for full year 2025, a year ahead of schedule— —Company pays down $75 million of debt; saves approximately $23.5 million over life of loan— —NDA submitted for ORLADEYO oral granules for children with HAE aged 2-11— —U.S. IND ...

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]

Core Insights - BioCryst Pharmaceuticals has appointed Steve Frank, a leader in healthcare investment banking, to its board of directors, enhancing its strategic capabilities in the biopharma sector [1][3]. Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on developing innovative therapies for rare diseases, leveraging expertise in structure-guided drug design [6]. - 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 [6]. Leadership and Expertise - Steve Frank has extensive experience in healthcare investment banking, previously serving as chairman of global healthcare investment banking at J.P. Morgan and leading Bear Stearns' healthcare investment banking before its acquisition [2]. - His background includes directing State Farm's multi-billion-dollar life science equity portfolio in the 1980s and 1990s, showcasing his investment acumen [2]. Strategic Positioning - BioCryst is positioned for growth with a commercial product nearing $1 billion in peak sales and a strong cash position that allows independence from capital markets [4]. - The company is focused on accelerating towards profitability while advancing its pipeline of potential best-in-class medicines [4].

Core Viewpoint - BioCryst Pharmaceuticals will report its first quarter 2025 financial results on May 5, 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 utilizes 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].