PresentationSteven SeedhouseMD & Biotechnology Analyst Good morning, everyone, and thanks so much for joining us for our next session. I'm Steve Seedhouse with the Cantor Biotech team. It's really a privilege to welcome our next participating company at the conference, BioCryst Pharmaceuticals. Thanks to everyone on the webcast and in the room for being here also. And I'm joined on stage by CFO, Babar Ghias and President and CCO, excuse me. And I guess there's a lot of change in the title. So we'll say emer ...

BioCryst Pharmaceuticals (BCRX) 2025 Conference September 04, 2025 09:45 AM ET Speaker0Good morning, everyone, and thanks so much for joining us for our next session. I'm Steve Seidos with the Cantor Biotech team. It's really a privilege to welcome our next participating company at the conference, BioCryst Pharmaceuticals. Thanks to everyone on the webcast and in the room for being here also. And I'm joined on stage by CFO, Bob R.Geiss and President and CEO CCO, excuse me, and guess there's a lot of change ...

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]

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ______________________ Commission File Number: 000-23186 Table of Contents 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 June 30, 2025 or Securities registered pursuant to Section 12(b) of the Act: | Title o ...

BioCryst Pharmaceuticals (BCRX) Q2 2025 Earnings Call August 04, 2025 08:30 AM ET Company ParticipantsJohn Bluth - Chief Communications OfficerJon Stonehouse - CEOCharlie Gayer - President & Chief Commercial OfficerBabar Ghias - CFO & Head - Corporate DevelopmentLaura Chico - Managing DirectorSteve Seedhouse - Biotechnology Equity ResearchHelen Thackray - Chief Research & Development OfficerTazeen Ahmad - MD - US Equity ResearchGena Huidong Wang - Managing Director, Biotech Equity ResearchBrian Abrahams - M ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $163.4 million, with $156.8 million coming from Orlodayo, representing a 45% year-over-year growth in quarterly revenue [20][21] - Non-GAAP operating expenses were $106.4 million, up from $87.4 million in 2024, while non-GAAP operating profit was $57 million, and non-GAAP net income was $32.3 million, resulting in a non-GAAP EPS of $0.15 [21][22] - The company generated $45 million in cash during the quarter and paid down $75 million in principal from its term loan in April and an additional $50 million in July, reducing term debt to $199 million [22] Business Line Data and Key Metrics Changes - Orlodayo had its best quarter since approval, with new patient prescriptions up over 10% compared to Q1 2021 and over 15% compared to Q1 2025, leading to revenue exceeding expectations by over $22 million [14][15] - The gross-to-net improvement was noted to be closer to 15%, with a significant increase in paid shipments contributing to revenue growth [20][98] Market Data and Key Metrics Changes - The U.S. accounted for almost 90% of Orlodayo revenue, with strong demand from Type I and II patients and increasing demand from patients with normal C1 inhibitor [20][18] - The company anticipates continued revenue growth momentum into 2026 and beyond, supported by the expected FDA approval of Orlodayo granules for pediatric use in December [18][19] Company Strategy and Development Direction - The company plans to leverage its commercial capabilities to consolidate rare disease assets and expand its product offerings, aiming for BioCryst 2.0 [10][11] - A definitive agreement was signed to sell the European business, which is expected to strengthen the company's financial position and allow for debt repayment [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching the upper half of the revenue guidance of $580 million to $600 million for the full year, even after the anticipated sale of the European business [15][19] - The management highlighted the importance of real-world evidence in building physician confidence and driving long-term growth [16][18] Other Important Information - The company is on track to generate approximately $700 million in cash by 2027 and plans to actively deploy this capital into value-creating opportunities [22][25] - The transition of leadership to Charlie Guyer as the new CEO was announced, with a focus on executing the company's growth strategy [11][12] Q&A Session Summary Question: What contributed to the 45% year-over-year growth in Orlodayo revenue? - The growth was attributed to a mix of volume increase, better paid rates, and improved efficiency in shipments [28][30] Question: What are the current discontinuation rates? - The one-year discontinuation rate remains solid at 60%, with a slight downward trend in overall discontinuation rates as the patient base grows [32][33] Question: How does Orlodayo's persistency compare to other injectable prophylactic regimens? - Orlodayo's one-year persistence rate is statistically similar to other products, with about 60% for all three compared therapies [39][40] Question: How are recent approvals affecting Orlodayo demand? - There has been a substantial increase in new patient prescriptions, indicating that physicians are not waiting for new products [43][44] Question: What is the current penetration rate into the addressable market? - Approximately 3,000 patients have tried Orlodayo, with about half still on therapy, indicating significant growth potential [51][52] Question: What is the expected impact of the upcoming pediatric PDUFA delay? - The FDA required more time for review, leading to a new PDUFA date of December 12, but the company remains optimistic about approval [45][46] Question: What is the competitive landscape for the pipeline assets? - The company is optimistic about its position in the market, noting that competitors have not made significant progress recently [76][77] Question: How does the company plan to deploy capital moving forward? - The company aims to consolidate rare disease assets and balance its portfolio with later-stage assets, leveraging its strong cash flow [84][86]

Group 1 - BioCryst Pharmaceuticals reported quarterly earnings of $0.15 per share, exceeding the Zacks Consensus Estimate of $0.03 per share, compared to a loss of $0.06 per share a year ago, representing an earnings surprise of +400.00% [1] - The company posted revenues of $163.35 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 9.74%, and compared to year-ago revenues of $109.33 million [2] - BioCryst has surpassed consensus EPS estimates two times over the last four quarters and topped consensus revenue estimates four times during the same period [2] Group 2 - The stock's immediate price movement will depend on management's commentary during the earnings call, with BioCryst shares gaining about 5.7% since the beginning of the year, compared to the S&P 500's gain of 6.1% [3] - The current consensus EPS estimate for the coming quarter is $0.06 on revenues of $155.49 million, and $0.13 on revenues of $609.2 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 32% of over 250 Zacks industries, indicating that the industry outlook can significantly impact stock performance [8]

Financial Performance & Guidance - BioCryst's Q2 2025 was strong, driven by increased ORLADEYO demand[14] - ORLADEYO revenue is expected to meet the previous guidance range of $580-600 million for FY25, even excluding Q4 2025 EU revenue[16] - The company anticipates achieving full-year operating profit in 2026 and positive net income & cash flows in 2026+[58] - Cash, cash equivalents, restricted cash & investments totaled $287 million as of June 30, 2025[63] - The company paid down $50 million of its senior credit facility in July 2025[62] ORLADEYO & Market Dynamics - Market research indicates a growing patient preference for oral administration of HAE long-term prophylaxis (LTP) since 2023[17] - Monte Carlo simulation projects ORLADEYO reaching a steady state of over 2,000 patients in the US by 2028[25] - ORLADEYO revenue advances to royalty-free tier (>$550M)[61] - The blended royalty rate for ORLADEYO is expected to decline to approximately 4% at peak sales once OMERS reaches its cap[67] Pipeline Development - The PDUFA target date for the pediatric NDA for ORLADEYO is December 12, 2025[32] - An IND has been cleared by the FDA for BCX17725, a targeted KLK5 inhibitor for treating Netherton syndrome (NS)[37]

BioCryst Pharmaceuticals (BCRX -2.33%), a biotechnology company specializing in oral treatments for rare diseases, released its second quarter earnings on August 4, 2025, reporting its strongest quarterly results to date. The headline news was the company's first significant profit on a generally accepted accounting principles (GAAP) basis, with GAAP revenue and non-GAAP earnings both outstripping Wall Street expectations. GAAP revenue was $163.4 million, 9.1% higher than the analyst consensus of $149.8 mil ...

—Company makes additional $50 million paydown of term debt and plans to retire all remaining term debt with proceeds of sale of European ORLADEYO business— RESEARCH TRIANGLE PARK, N.C., Aug. 04, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the second quarter ended June 30, 2025, and provided a corporate update. "The financial performance this quarter is the best in the company's history resulting from better-than-expected revenue growth and very ...