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BioCryst to Present New ORLADEYO® (berotralstat) Results from APeX-P Pediatric Trial at 2025 American Academy of Allergy, Asthma & Immunology / World Allergy Organization Joint Congress
GlobeNewswire· 2025-02-10 13:30
Core Insights - BioCryst Pharmaceuticals will present five abstracts on ORLADEYO (berotralstat) at the 2025 AAAAI/WAO joint congress, focusing on its use for hereditary angioedema (HAE) [1][2] Group 1: Product Information - ORLADEYO is the first and only oral therapy specifically designed to prevent HAE attacks in patients aged 12 years and older, administered as one capsule daily [3][4] - The drug functions as a plasma kallikrein inhibitor, reducing the activity of plasma kallikrein to prevent HAE attacks [3] Group 2: Clinical Trials and Research - A late-breaking abstract will present results from the APeX-P trial, which evaluates ORLADEYO in pediatric patients aged 2 to under 12 years with HAE [2] - The five abstracts will cover various aspects, including real-world attack rates before and after berotralstat initiation and patient-reported impacts on attack frequency and severity [8] Group 3: Safety and Efficacy - The safety and effectiveness of ORLADEYO for treating acute HAE attacks have not been established, and it is not recommended for such use [5][10] - Common adverse reactions include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease, occurring in 10% or more of patients [6] Group 4: Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on developing therapies for hereditary angioedema and other rare diseases, leveraging expertise in structure-guided drug design [11]
BioCryst to Report Fourth Quarter 2024 Financial Results on February 24
Newsfilter· 2025-02-10 12:00
Core Viewpoint - BioCryst Pharmaceuticals, Inc. will report its fourth quarter 2024 financial results on February 24, 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 complement-mediated and other rare diseases [3]. - The company utilizes structure-guided drug design to develop first-in-class or best-in-class small-molecule and protein therapeutics aimed at challenging diseases [3]. - BioCryst has commercialized ORLADEYO® (berotralstat), which is the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies [3].
BioCryst Announces Preliminary Full Year 2024 ORLADEYO® (berotralstat) Net Revenue of $437 Million (+34 percent y-o-y)
GlobeNewswire· 2025-01-10 12:00
Core Insights - BioCryst Pharmaceuticals expects ORLADEYO net revenue to be between $515 million and $535 million in 2025, with total revenue (including RAPIVAB) projected between $540 million and $560 million [1][5] - The company achieved operating profit in 2024 (excluding stock-based compensation) and anticipates approaching quarterly EPS profitability and positive cash flow in the second half of 2025 [1][8] - A new drug application for ORLADEYO granules aimed at children up to age 12 is planned for submission in 2025, addressing a significant unmet medical need [1][2] - The pipeline is advancing with clinical programs for BCX17725 (Netherton syndrome) and avoralstat (diabetic macular edema) expected to progress in 2025 [1][2] Revenue Performance - Preliminary, unaudited ORLADEYO net revenue for Q4 2024 was $123.5 million, reflecting a 36% year-over-year increase, while full-year 2024 net revenue reached $437 million, up 34% year-over-year [3][4] - Total revenue for Q4 2024 was $130.8 million, a 40% increase year-over-year, with full-year total revenue at $450 million, marking a 36% growth year-over-year [5] Operating Expenses - The company forecasts full-year 2025 GAAP operating expenses to be between $485 million and $495 million, which includes an estimated $60 million for stock-based compensation [6] - Operating expenses, excluding stock-based compensation, are projected to be between $425 million and $435 million, reflecting additional investments for the pediatric product launch and ongoing clinical activities [6] Profitability Outlook - Revenue growth in 2024 significantly outpaced operating expense growth, and this trend is expected to continue [7] - The company anticipates an annual compound annual growth rate (CAGR) for revenue of around 20% over the next three years, compared to a projected CAGR of approximately 5% for operating expenses [8] - BioCryst expects to achieve quarterly positive EPS and positive cash flow in the second half of 2025, with full-year profitability anticipated in 2026 [8]
BioCryst to Present at 43rd Annual J.P. Morgan Healthcare Conference
Newsfilter· 2025-01-07 12:00
RESEARCH TRIANGLE PARK, N.C., Jan. 07, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 14, 2025, at 6:00 p.m. ET. Link to the live audio webcast and replay of the presentation may be accessed in the Investors & Media section of BioCryst's website at www.biocryst.com. About BioCryst PharmaceuticalsBioCryst Pharmaceuticals is a global biotechnology compa ...
BioCryst Pharmaceuticals(BCRX) - 2024 Q3 - Quarterly Report
2024-11-05 22:19
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.01 BCRX Nasdaq Global Select Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ ...
BioCryst Pharmaceuticals(BCRX) - 2024 Q3 - Earnings Call Transcript
2024-11-04 16:00
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) Q3 2024 Earnings Conference Call November 4, 2024 8:30 AM ET Company Participants John Bluth - Chief Communications Officer Jon Stonehouse - CEO Charlie Gayer - Chief Commercial Officer Anthony Doyle - CFO Helen Thackray - Chief R&D Officer Jinky Rosselli - Chief Data and Insights Officer Conference Call Participants Nick Lenard - JPMorgan Tazeen Ahmad - Bank of America Brian Abrahams - RBC Capital Markets Maury Raycroft - Jefferies Stacy Ku - TD Cowen Liisa Bayk ...
BioCryst Pharmaceuticals (BCRX) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-04 14:10
BioCryst Pharmaceuticals (BCRX) came out with a quarterly loss of $0.07 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this drugmaker would post a loss of $0.19 per share when it actually produced a loss of $0.06, delivering a surprise of 68.42%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.BioCryst, which belongs to the ...
BioCryst Pharmaceuticals(BCRX) - 2024 Q3 - Earnings Call Presentation
2024-11-04 13:33
| --- | --- | --- | |-------------------------------------------------------|-------|-------| | | | | | | | | | | | | | Third Quarter 2024 Results Call | | | | Corporate Update & Financial Results November 4, 2024 | | | | CONFIDENTIAL & PROPRIETARY | | | Forward-looking statements BioCryst's presentation contains forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information and company performance, achievements, or future market share. These s ...
BioCryst Pharmaceuticals(BCRX) - 2024 Q3 - Quarterly Results
2024-11-04 12:06
EXHIBIT 99.1 BioCryst Reports Third Quarter 2024 Financial Results and Provides Business Update — Q3 2024 ORLADEYO net revenue of $116.3 million (+35.7 percent y-o-y) — — Full-year 2024 ORLADEYO revenue guidance adjusted to $430-$435 million (top end of prior guidance range) — — Company introduces full-year 2024 total product revenue guidance of $443-$448 million based on additional 2024 revenue from RAPIVAB — — BCX17725 for Netherton syndrome advances into the clinic — — Company generates GAAP operating pr ...
How Much Upside is Left in BioCryst (BCRX)? Wall Street Analysts Think 79.5%
ZACKS· 2024-10-23 14:56
BioCryst Pharmaceuticals (BCRX) closed the last trading session at $7.95, gaining 4.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $14.27 indicates a 79.5% upside potential.The mean estimate comprises 11 short-term price targets with a standard deviation of $6.71. While the lowest estimate of $7 indicates a 12% decline from the current price level, the most optimistic analyst e ...