Earnings summaries and quarterly performance for BIOCRYST PHARMACEUTICALS.
Executive leadership at BIOCRYST PHARMACEUTICALS.
Board of directors at BIOCRYST PHARMACEUTICALS.
Research analysts who have asked questions during BIOCRYST PHARMACEUTICALS earnings calls.
Brian Abrahams
RBC Capital Markets
4 questions for BCRX
Jessica Fye
JPMorgan Chase & Co.
4 questions for BCRX
Serge Belanger
Needham & Company
4 questions for BCRX
Stacy Ku
TD Cowen
4 questions for BCRX
Huidong Wang
Barclays
3 questions for BCRX
Maurice Raycroft
Jefferies Financial Group
3 questions for BCRX
Tazeen Ahmad
Bank of America
3 questions for BCRX
Jonathan Wolleben
JMP Securities, a Citizens Company
2 questions for BCRX
Laura Chico
Wedbush Securities
2 questions for BCRX
Liisa Bayko
Evercore ISI
2 questions for BCRX
Gena Wang
Barclays
1 question for BCRX
Jon Wolleben
Citizen JMP
1 question for BCRX
Maury Raycroft
Jefferies
1 question for BCRX
Seema Sheoran
Evercore ISI
1 question for BCRX
Steven Seedhouse
Raymond James
1 question for BCRX
Steve Seedhouse
Cantor Fitzgerald
1 question for BCRX
Recent press releases and 8-K filings for BCRX.
- BioCryst Pharmaceuticals, Inc. announced on December 12, 2025, that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for an oral pellet formulation of ORLADEYO® (berotralstat).
- This approval is for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years, making ORLADEYO the first and only targeted oral prophylactic therapy for HAE patients aged 2 and above.
- The new oral pellet formulation offers a child-friendly method of administration.
- ORLADEYO was previously approved in December 2020 for patients 12 years and older and has been prescribed to more than 3,500 patients in the U.S. to date.
- The approval was supported by positive interim data from the APeX-P clinical trial, which showed ORLADEYO was well tolerated and resulted in early and sustained reductions in monthly attack rates in the pediatric age group.
- BioCryst Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years.
- This approval establishes ORLADEYO as the first and only targeted oral prophylactic therapy for HAE patients aged 2 and older, offering a child-friendly administration method.
- The approval was supported by positive interim data from the APeX-P clinical trial, which demonstrated the treatment was well tolerated and led to early and sustained reductions in monthly attack rates.
- BioCryst has also filed applications for ORLADEYO oral pellets with the European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency, with additional regulatory filings planned in other global territories, including Canada.
- BioCryst Pharmaceuticals expects ORLADEYO revenue to be between $590-$600 million for the year, with a projected peak sales guidance of $1 billion by 2029.
- The company achieved its first year of profitability ahead of schedule and anticipates continued profitability even after the proposed acquisition of Astria.
- The proposed acquisition of Astria, which includes the late-stage HAE asset Nevenabart, is on track for a Q1 2026 closing. Nevenabart is anticipated to launch in late 2028.
- BioCryst completed the divestiture of its EU business for $250 million, which supported the Astria acquisition and improved the balance sheet.
- The company lowered its expense guidance from $440-$450 million to $430-$440 million.
- BioCryst Pharmaceuticals anticipates ORLADEYO sales of $590-$600 million for the current year and maintains its $1 billion peak sales guidance by 2029, supported by strong US growth and the expected pediatric indication approval. The company achieved profitability this year, a year ahead of schedule, and expects to sustain it.
- The company divested its EU business for $250 million, which was previously loss-making or break-even, to strengthen its balance sheet and facilitate the proposed acquisition of Astria Pharmaceuticals. This acquisition, on track for Q1 2026 closing, adds the late-stage HAE asset Nevenabart, projected to launch in the latter part of 2028.
- BioCryst has lowered its expense guidance from $440-$450 million to $430-$440 million for the current year, with expectations for significantly reduced expenses and higher operating profitability in 2027 and beyond.
- Upcoming pipeline catalysts include a PDUFA date on December 12 for ORLADEYO's pediatric indication and initial data for its Netherton Syndrome program (17725) by the end of Q1 next year.
- BioCryst Pharmaceuticals anticipates ORLADEYO revenue between $590-$600 million for the current year, with a projected $1 billion in peak sales by 2029, supported by strong US growth and the upcoming pediatric indication.
- The company completed an EU divestiture of ORLADEYO for $250 million, which strengthened its financial position and facilitated the proposed acquisition of Astria.
- The acquisition of Astria is on track to close in Q1 2026, adding the late-stage HAE asset Nevenabart, with a projected launch in late 2028 following top-line pivotal data in Q1 2027.
- BioCryst achieved its first year of profitability ahead of schedule and expects to maintain profitability, with lowered expense guidance to $430-$440 million.
- BioCryst Pharmaceuticals announced new data from the APeX-P clinical trial, demonstrating early and sustained reductions in monthly HAE attack rates over one year in pediatric patients aged 2 to <12 years treated with once-daily ORLADEYO® (berotralstat) oral granules.
- Key findings from the trial include 65.5% of patients being attack-free at month 1 and 70.4% at month 12, with a median attack rate of 0 for 11 out of 12 months, and 93.1% of patients completing ≥48 weeks of treatment.
- The New Drug Application (NDA) for ORLADEYO oral granules for pediatric patients aged 2 to <12 years is under review with the U.S. FDA, with a target action date of December 12, 2025.
- If approved, ORLADEYO would be the first and only targeted oral prophylactic therapy for patients with HAE aged 2 to less than 12 years.
- BioCryst reported ORLADEYO revenue of $159.1 million for Q3 2025, representing 37% year-over-year growth, and raised its full-year 2025 ORLADEYO revenue guidance to between $590 million and $600 million. The company also lowered its non-GAAP operating expense guidance to $430-$440 million.
- The sale of BioCryst's European business was closed on October 1, enabling the full repayment of its Pharmakon debt. The company announced the proposed acquisition of Astria Therapeutics, expected to close in Q1 2026, and secured a strategic financing partnership with Blackstone for up to $400 million. BioCryst reported non-GAAP operating profit of $51.7 million and non-GAAP net income of $35.6 million for Q3 2025, ending the quarter with a pro forma cash balance of approximately $294 million and zero term debt.
- In pipeline updates, early data for the DME program is expected early next year, after which BioCryst plans to spin out or partner the program. For BCX-17725 in Netherton syndrome, encouraging healthy volunteer data showed drug distribution to the skin, with early patient data now expected later in Q1 next year. Additionally, Charlie Gayer will transition to CEO on January 1, with Ron Dellinger becoming Chief Commercial Officer.
- BioCryst reported ORLADEYO revenue growth of +37% year-over-year for Q3 2025 and raised its FY25 guidance range to $590-600 million.
- The company announced the acquisition of Astria for approximately $700 million Total Enterprise Value, comprising an equity portion of ~$280 million and a cash portion of ~$420 million, with expectations to remain profitable and cash flow positive post-transaction.
- As of September 30, 2025, BioCryst held $269 million in cash, cash equivalents, restricted cash & investments, with a pro forma cash position of $294 million.
- Initial data from Part 3 of the BCX17725 Phase 1 trial for Netherton syndrome patients is anticipated by the end of Q1 2026.
- BioCryst reported Q3 2025 ORLADEYO net revenue of $159.1 million, representing a 37% year-over-year increase.
- The company achieved Q3 2025 GAAP operating profit of $29.6 million and non-GAAP operating profit of $51.7 million.
- Net income for Q3 2025 was $12.9 million ($0.06 per share), with non-GAAP net income at $35.6 million ($0.17 per share).
- BioCryst raised its full-year 2025 ORLADEYO net revenue guidance to between $590 million and $600 million and lowered its non-GAAP operating expense guidance to between $430 million and $440 million.
- Strategic developments include the completion of the European ORLADEYO business sale, which retired all remaining Pharmakon term debt, and a definitive agreement to acquire Astria Therapeutics, expected to close in Q1 2026.
- BioCryst announced its intent to acquire Astria Therapeutics for a total enterprise value of approximately $700 million.
- The acquisition implies a value of $13 per share in cash and stock for Astria stockholders, who are expected to own 15% of proforma equity.
- This transaction is expected to expand and strengthen BioCryst's presence in HAE, transform its revenue growth profile, and be significantly accretive to operating profit (non-GAAP) in the first full year of launch.
- BioCryst anticipates remaining profitable (non-GAAP) and cash flow positive post-transaction, with an expected cash balance of $1B+ by 2029.
- The transaction is expected to close in Q1 2026.
Quarterly earnings call transcripts for BIOCRYST PHARMACEUTICALS.
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