BioCryst Pharmaceuticals

BioCryst Pharmaceuticals, Inc. is a commercial-stage biotechnology company that discovers novel, oral, and small-molecule medicines. The firm focuses on the treatment of rare diseases in which unmet medical needs exist and an enzyme in the biological pathway of the disease. Its programs include BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for marburg virus disease and yellow fever. The company was founded in 1986 and is headquartered in Durham, NC.

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BioCryst projects $1B peak sales for ORLADEYO, eyes global expansion

BioCryst Pharmaceuticals showcased strong performance driven by ORLADEYO's success, with a clear path towards $1 billion in peak sales and global expansion.
While facing challenges such as delays in BCX10013's development and managing expenses, the company remains focused on maximizing product value and market opportunities.
Opportunities lie in expanding ORLADEYO's market presence, exploring international sales, and investing in R&D for future growth and innovation.

BioCryst projects strong revenue growth for ORLADEYO, faces regulatory hurdles

BioCryst Pharmaceuticals demonstrates strong performance and revenue growth potential for ORLADEYO, aiming to exceed $320 million guidance for the year.
Challenges include revenue impact from free drug complexities and regulatory delays, with opportunities in global market expansion and pediatric therapy development.
The company's focus on patient care, financial stability, and long-term sales outlook positions BioCryst for continued growth and success in the pharmaceutical market.

BioCryst Pharmaceuticals on track to hit $320M in ORLADEYO sales

BioCryst Pharmaceuticals is confident in reaching $320 million in ORLADEYO sales this year through patient growth. Q3 and Q4 revenue growth expected to be steady, with opportunities for expansion outside the U.S.

BioCryst's ORLADEYO excels in Q3, faces challenges and growth opportunities

BioCryst Pharmaceuticals continues to see strong performance with ORLADEYO revenue and patient growth.
The company faces challenges with co-payment assistance programs and competitive market dynamics.
Opportunities lie in market education, pediatric patient expansion, and maintaining a competitive edge.
Despite expected expense increases, BioCryst remains focused on value creation and long-term growth.

BioCryst reports robust earnings, eyes $1B peak revenue for ORLADEYO

BioCryst Pharmaceuticals showcased strong financial performance and positive long-term data for ORLADEYO, aiming for $1 billion in global peak revenue.
While facing challenges with patient retention and market access, the company emphasized its growing product portfolio and accelerated path to profitability.
Opportunities lie in achieving profitability by 2026, improving market access, and leveraging therapy efficacy to drive revenue growth and market expansion.

BioCryst Pharmaceuticals excels in Q1, eyes Japanese market expansion

BioCryst Pharmaceuticals delivered strong Q1 results driven by ORLADEYO sales, raising revenue guidance for 2024 and advancing pipeline programs.
While facing challenges in expenses and gross to net margins, the company's strategic focus on market expansion and pipeline development presents growth opportunities.
Overall, BioCryst Pharmaceuticals shows promise with a balanced patient mix, strong market research projections, and high strategic interest in its flagship product.

BioCryst's ORLADEYO excels, revenue guidance raised amidst operational achievements

BioCryst Pharmaceuticals showcased robust performance in Q2 driven by ORLADEYO, with strong revenue growth and operational achievements.
Despite challenges like product portfolio diversification and profitability targets, the company's strategic focus on ORLADEYO's market expansion and revenue guidance increase highlights growth potential.
Opportunities lie in further leveraging ORLADEYO's success, exploring new market segments, and enhancing market strategies to drive sustained growth and market leadership.

BioCryst Pharmaceuticals reports robust revenue growth and pipeline advancements

BioCryst Pharmaceuticals delivered strong financial results driven by ORLADEYO's performance, showcasing market acceptance and revenue growth.
The company's pipeline advancements and proactive management approach position them well for future growth and product portfolio expansion.
While facing challenges in sustaining momentum and managing competition, BioCryst Pharmaceuticals has opportunities to capitalize on market demand and optimize operational strategies for long-term success.

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BioCryst Pharmaceuticals, Inc. is a biotechnology company. It engages in the provision of structure-guided drug design with the goal of developing oral small-molecule and protein therapeutics to target difficult-to-treat rare diseases. The company was founded by William M. Spencer III, Charles E. Bugg, and John A. Montgomery in 1986 and is headquartered in Durham, NC.

RESEARCH TRIANGLE PARK, N.C., May 14, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) today announced that new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Valencia, Spain from May 31 to June 3, 2024.

BioCryst to Present New Data at 2024 Meeting of the European Academy of Allergy and Clinical Immunology

RESEARCH TRIANGLE PARK, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Federal Commission for Protection against Health Risks (COFEPRIS) in Mexico has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.

ORLADEYO® (berotralstat) Approved in Mexico

RESEARCH TRIANGLE PARK, N.C., May 09, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new real-world evidence on the use of oral, once-daily ORLADEYO® (berotralstat) demonstrating that patients with hereditary angioedema (HAE) in the United States experience significant reductions in healthcare resource utilization (HRU) after beginning treatment with ORLADEYO.

BioCryst Presents New Real-world Evidence Showing Significant Reductions in Healthcare Resource Utilization Among Patients with HAE Following Initiation of ORLADEYO® (berotralstat)

The company unveiled its first-quarter earnings that morning. It notched convincing beats on both the top and bottom lines.

Why BioCryst Pharmaceuticals Vaulted Nearly 20% Higher on Monday

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX ) Q1 2024 Earnings Call Transcript May 6, 2024 8:30 AM ET Company Participants John Bluth - IR Jon Stonehouse - CEO Charlie Gayer - CCO Helen Thackray - Chief R&D Officer Anthony Doyle - CFO Conference Call Participants Maury Raycroft - Jefferies Tazeen Ahmad - Bank of America Serge Belanger - Needham & Company Liisa Bayko - Evercore ISI Stacy Ku - TD Cowen Gena Wang - Barclays Francois Brisebois - Oppenheimer Jon Wolleben - JMP Securities Chris Raymond - Piper Sandler Operator Good morning, and welcome to the BioCryst First Quarter 2024 Earnings Call. All participants will be in listen-only mode.

BioCryst Pharmaceuticals, Inc. (BCRX) Q1 2024 Earnings Call Transcript

BioCryst Pharmaceuticals (BCRX) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.28 per share a year ago.

BioCryst Pharmaceuticals (BCRX) Reports Q1 Loss, Tops Revenue Estimates

—Q1 2024 ORLADEYO net revenue grows 30 percent y-o-y to $88.9 million— —Full-year 2024 ORLADEYO revenue guidance adjusted to $390-$400 million (top end of prior guidance range) — —Pipeline programs, including BCX17725 for Netherton syndrome and avoralstat for DME, advancing on schedule into clinical trials— RESEARCH TRIANGLE PARK, N.C., May 06, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

BioCryst Reports First Quarter 2024 Financial Results and Provides Business Update

BioCryst (BCRX) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

BioCryst Pharmaceuticals (BCRX) Expected to Beat Earnings Estimates: What to Know Ahead of Q1 Release

RESEARCH TRIANGLE PARK, N.C., April 22, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will report its first quarter 2024 financial results on Monday, May 6, 2024.

BioCryst to Report First Quarter 2024 Financial Results on May 6

RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Brazilian Health Regulatory Agency

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BioCryst Pharmaceuticals, Inc. (BCRX) Q4 2023 Earnings Call Transcript

BioCryst Pharmaceuticals (BCRX) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.24. This compares to loss of $0.38 per share a year ago.

BioCryst Pharmaceuticals (BCRX) Reports Q4 Loss, Tops Revenue Estimates

—ORLADEYO net revenue of $90.9 million for Q4 2023 and $326.0 million for FY 2023  (+30 percent y-o-y) —

BioCryst Reports Fourth Quarter and Full Year 2023 Financial Results and Upcoming Key Milestones

RESEARCH TRIANGLE PARK, N.C., Feb. 23, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new analyses of real-world use of oral, once-daily ORLADEYO® (berotralstat) that showed patients who initiated ORLADEYO experienced rapid, substantial and sustained reductions in attack rates through 18 months of treatment regardless of the severity of their disease, their history of prior prophylaxis or their C1-inhibitor (C1-INH) level and function.

BioCryst Presents New Real-world Data Showing Rapid, Substantial and Sustained HAE Attack Rate Reductions After Beginning ORLADEYO® (berotralstat) Treatment

RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients in Italy now have access to the first oral, once-daily therapy for the routine prevention of recurrent HAE attacks.

BioCryst Launches ORLADEYO® (berotralstat) in Italy

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will report its fourth quarter 2023 financial results on Monday, February 26, 2024.

BioCryst to Report Fourth Quarter 2023 Financial Results on February 26

RESEARCH TRIANGLE PARK, N.C. , Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present five abstracts featuring new analyses of real-world use of oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) in patients 12 years and older at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting. The meeting will take place at the Walter E. Washington Convention Center in Washington, D.C., from February 23-26, 2024.

BioCryst to Present New ORLADEYO® (berotralstat) Real-world Data at 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

BioCryst (BCRX) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

BioCryst (BCRX) Moves 25.6% Higher: Will This Strength Last?

—ORLADEYO preliminary 2023 full year net revenue of $325 million (+29 percent y-o-y)— —ORLADEYO net revenue expected to be between $380-$400 million in 2024, on trajectory for $1 billion in peak sales— —Operating expenses expected to remain flat ($365-$375 million) in 2024— —Company expects operating profit in 2024, approaching positive EPS and positive cash flow in 2H 2025— RESEARCH TRIANGLE PARK, N.C., Jan. 05, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced preliminary, unaudited ORLADEYO® (berotralstat) net revenue for the fourth quarter and full year 2023.

BioCryst Announces Preliminary Full Year 2023 ORLADEYO® (berotralstat) Net Revenue of $325 Million, Provides 2024 Guidance and Accelerated Path to Profitability

RESEARCH TRIANGLE PARK, N.C., Jan. 03, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 9, 2024, at 6:00 p.m. ET.

BioCryst to Present at 42nd Annual J.P. Morgan Healthcare Conference

– Results published in JACI: In Practice show rapid and sustained reductions in HAE attacks and improved quality of life over 96 weeks of treatment with ORLADEYO – – Results published in JACI: In Practice show rapid and sustained reductions in HAE attacks and improved quality of life over 96 weeks of treatment with ORLADEYO –

BioCryst Announces Publication of Data from Open-label Extension of the APeX-2 Pivotal Trial of ORLADEYO® (berotralstat)

BioCryst Pharmaceuticals, Inc. proof-of-concept data from a phase 1 study, using BCX10013 for the treatment of patients with complement-mediated disorders, is expected in 2024. Oral C2, C5, and Bifunctional inhibitor drugs are also being advanced to treat patients with complement-mediated disorders. Net revenue for Q3 of 2023 came in at $85.7 million, which was a 29.8% year-over-year increase.

BioCryst: Factor D Inhibitor Data In 2024 Should Be Watched Closely

RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina

RESEARCH TRIANGLE PARK, N.C., Nov. 21, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Spanish Ministry for Health (Ministerio de Sanidad) has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older.

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