Core Insights - BioCryst Pharmaceuticals has successfully completed the sale of its European ORLADEYO business to Neopharmed Gentili for $250 million upfront, with potential future milestones of up to $14 million based on sales in Central and Eastern Europe [1][2][3] - The divestiture is expected to improve BioCryst's operating margin as the European business was approximately breakeven on a direct basis [2] - Following the sale, BioCryst will concentrate on increasing ORLADEYO sales in the US market while Neopharmed Gentili will manage commercialization in Europe [2][3] - Despite the loss of European revenue, BioCryst is projected to meet the upper half of its 2025 revenue guidance range of $580 million to $600 million [3] Financial Impact - The transaction is valued at $250 million upfront, which will enhance BioCryst's financial position [1] - Future milestones could add an additional $14 million based on performance in specific European markets [1] Strategic Focus - BioCryst will shift its focus to the US market for ORLADEYO sales, indicating a strategic realignment post-divestiture [2][3] - Neopharmed Gentili will retain the European commercial organization established by BioCryst, ensuring operational continuity in Europe [2]

Core Insights - BioCryst Pharmaceuticals has completed the sale of its European ORLADEYO business to Neopharmed Gentili for $250 million, with potential future milestones of up to $14 million [1][8] - The transaction allows BioCryst to focus on its core U.S. market, significantly improving its operating margin and cash flow generation [2][8] - Neopharmed Gentili will manage the commercialization of ORLADEYO in Europe, retaining the existing European commercial organization built by BioCryst [8] Transaction Details - The sale price of $250 million reflects a multiple of approximately 5.4 times sales over the last twelve months ending June 2025 [8] - BioCryst intends to use the proceeds to retire a $199 million Pharmakon term loan, resulting in a cleaner balance sheet for future strategic activities [8] Strategic Advantages - The divestiture of the European business, which was approximately breakeven on a direct basis, provides an immediate improvement to BioCryst's operating margin [8] - The transaction enhances BioCryst's strategic optionality and positions the company to reach the upper half of its 2025 revenue guidance range of $580 million to $600 million, even without European revenue [2][8]

Core Insights - BioCryst Pharmaceuticals announced the departure of Dr. Helen Thackray, the chief research and development officer, effective September 1, 2025, transitioning to an advisory role until the end of the year [1][2] - Dr. Thackray joined BioCryst in 2019 as a board member and became the chief research and development officer in 2021, being a finalist for the CEO succession process [2] - The CEO of BioCryst, Jon Stonehouse, expressed gratitude for Dr. Thackray's contributions, including the launch of a new protein therapeutics platform and advancements in various clinical programs [3] Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of individuals with hereditary angioedema and other rare diseases [5] - The company utilizes structure-guided drug design to develop innovative oral small-molecule and protein therapeutics targeting challenging diseases [5] - BioCryst has commercialized ORLADEYO (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of therapies [5]

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]

RESEARCH TRIANGLE PARK, N.C., July 21, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will report its second quarter 2025 financial results on Monday, August 4, 2025. BCRXW Contact: John Bluth +1 919 859 7910 jbluth@biocryst.com About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema and other rare diseases. BioCryst leverages it ...

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]

RESEARCH TRIANGLE PARK, N.C., July 07, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the appointment of Babar Ghias as chief financial officer (CFO) and head of corporate development. Mr. Ghias joins BioCryst from AvenCell Therapeutics, a clinical-stage CAR-T company focused on hematologic malignancies, where he served as CFO since 2022. "Babar brings extensive deal making and operational experience in addition to his previous roles as a CFO at rare disease companies ...

Core Viewpoint - BioCryst Pharmaceuticals has entered into a definitive agreement to sell its European ORLADEYO business to Neopharmed Gentili for up to $264 million, which includes $250 million upfront and up to $14 million in future milestones [1][8] Financial Impact - BioCryst plans to use the proceeds from the transaction to retire all remaining term debt of $249 million, eliminating approximately $70 million in future interest payments [2][8] - The company expects to end 2027 with approximately $700 million in cash and no term debt, an increase of $400 million from prior net cash guidance [2][8] Strategic Rationale - The transaction aligns with BioCryst's strategy to make ORLADEYO available to patients in Europe while providing capital to retire debt, resulting in a higher margin business [3] - Neopharmed Gentili aims to leverage this acquisition to enhance its position in the rare disease field and strengthen its growth trajectory as a leading European specialty pharmaceutical company [4] Operational Efficiency - The acquisition will enable commercial continuity for ORLADEYO and is expected to result in at least $50 million in annual operating expense savings for BioCryst [8] Advisory and Legal Support - BofA Securities, Inc. and TD Cowen are serving as financial advisors to BioCryst, while Centerview Partners UK LLP is acting as exclusive financial advisor to Neopharmed Gentili [6]

Core Insights - BioCryst Pharmaceuticals announced new data demonstrating the long-term efficacy and safety of ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) across all age groups [1][2] Group 1: Efficacy and Safety - Data from clinical trials and real-world settings indicate that ORLADEYO is an effective and well-tolerated long-term prophylactic treatment for HAE, with patients experiencing fewer and less severe attacks [2] - The ongoing APeX-P study shows that berotralstat significantly reduces the number of HAE attacks requiring treatment or professional care in pediatric patients aged 2 to 11 years [4] - In the Berolife study, patients aged over 12 years reported a mean baseline attack rate of 1.1 attacks per month, which decreased significantly during treatment [7][10] Group 2: Quality of Life Improvements - Patients reported an 86% reduction in attacks requiring professional care, with the mean adjusted monthly attack rate decreasing from 1.28 to 0.38 during the initial weeks of treatment [10] - Significant improvements in quality of life were observed, with 60% of patients achieving the Minimal Clinically Important Difference (MCID) in the Angioedema Quality of Life Questionnaire (AE-QoL) total score at week 24 [20] - Participants noted reduced frequency and severity of HAE attacks, leading to improved disease management and a greater sense of normalcy in daily life [21] Group 3: Patient Experience - A qualitative study revealed that 71% of participants had switched to berotralstat from previous treatments due to long-term tolerability concerns [14] - Patients described berotralstat as less burdensome and easier to incorporate into daily routines compared to prior therapies, contributing to enhanced quality of life [21] Group 4: Product Information - ORLADEYO is the first and only oral therapy specifically designed to prevent HAE attacks in patients aged 12 years and older, functioning as a plasma kallikrein inhibitor [16][17] - The recommended dosage is 150 mg once daily, with specific recommendations for patients with hepatic impairment [22]

Core Viewpoint - BioCryst Pharmaceuticals has received approval from INVIMA in Colombia for ORLADEYO (berotralstat) as a prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older, marking a significant advancement in treatment options for HAE in the pan-Latin America region [1][2]. Group 1: Product Information - ORLADEYO is the first and only oral therapy specifically designed to prevent HAE attacks in adults and pediatric patients aged 12 years and older, administered as one capsule daily [4]. - The drug functions by inhibiting plasma kallikrein, which is involved in the pathophysiology of HAE [4]. - ORLADEYO has already received regulatory approvals in several Latin American countries, including Chile, Argentina, Brazil, Mexico, and Peru [3]. Group 2: Commercial Strategy - BioCryst has an exclusive collaboration with Pint Pharma GmbH for the registration and promotion of ORLADEYO in the pan-Latin America region, with Pint responsible for obtaining marketing authorizations and commercialization [3]. - Following the approval from INVIMA, BioCryst is working with Pint Pharma to ensure the availability of ORLADEYO to patients in Colombia [2]. Group 3: Safety and Usage Information - ORLADEYO is indicated for the prophylaxis of HAE attacks but is not approved for the treatment of acute HAE attacks [5][6]. - The recommended dosage is 150 mg once daily, with a reduced dosage of 110 mg for patients with moderate or severe hepatic impairment [7]. - Common adverse reactions include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease, occurring in 10% or more of patients [7].