BioCryst Pharmaceuticals (NasdaqGS:BCRX) Q4 2025 Earnings call February 26, 2026 08:30 AM ET Company ParticipantsBabar Ghias - Chief Financial Officer and Head of Corporate DevelopmentBill Sheridan - Chief Development OfficerBrian Abrahams - Managing DirectorCharlie Gayer - President and CEOLaura Chico - Managing Director, Equity ResearchMikaela Vanik - Research AssociateNick Wilder - Manager, Investor RelationsConference Call ParticipantsNone - AnalystNone - AnalystNone - AnalystNone - AnalystOperatorWelco ...

—Full year 2025 ORLADEYO® net revenue of $601.8 million (+38% y-o-y; +43% y-o-y excluding European ORLADEYO revenue following the sale of the European ORLADEYO business to Neopharmed Gentili S.p.A. on October 1, 2025)— —Record GAAP and non-GAAP operating profit for full year 2025— —Maintained full year 2026 ORLADEYO revenue guidance between $625 and $645 million— —Received FDA approval for ORLADEYO oral pellets for patients with HAE Aged 2 to <12 Years— —Completed Acquisition of Astria Therapeutics— RESEARC ...

Core Insights - BioCryst Pharmaceuticals will present nine abstracts from its hereditary angioedema (HAE) portfolio at the 2026 AAAAI Annual Meeting in Philadelphia from February 27 to March 2, 2026 [1][2] HAE Portfolio Developments - Six abstracts will focus on new clinical trial and real-world outcomes with ORLADEYO (berotralstat), the first targeted oral prophylactic therapy for HAE patients aged 2 and older [2] - Three abstracts will present new clinical trial outcomes with navenibart, a long-acting monoclonal antibody plasma kallikrein inhibitor [2] - A late-breaking presentation will highlight positive interim results from the ALPHA-SOLAR trial, showing sustained HAE attack suppression with navenibart administered every 3 or 6 months [2][4] Strategic Focus - The data presented reflects BioCryst's strategy to expand and diversify its HAE portfolio, aiming to provide meaningful treatment options that align with patient needs [3] - The company is advancing programs like navenibart and launching an expanded pediatric indication for ORLADEYO [3] Presentation Details - BioCryst will present eight posters on February 27, 2026, and one late-breaking abstract on March 1, 2026, at the Convention Center, Level 2, Hall E [4] Product Information - ORLADEYO (berotralstat) is the first oral therapy specifically designed to prevent HAE attacks in patients aged 2 years and older [5] - Navenibart is an investigational monoclonal antibody being evaluated for long-term prevention of HAE attacks, with potential dosing every 3 or 6 months [6] Research Findings - Interim data from the APeX-P trial indicates that oral berotralstat reduces the rate of moderate and severe attacks in children aged 2 to less than 12 years [7] - Various posters will present real-world evidence on the impact of berotralstat on attack rates and healthcare resource utilization among patients with C1-inhibitor deficiency [7]

Company Overview - BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) specializes in treatments for rare diseases, including an oral medication for hereditary angioedema and an injectable flu therapy [3] - The company is also engaged in discovering and testing new drugs for allergic and immunological conditions [3] Recent Developments - On January 23, BioCryst finalized a $700 million acquisition of Astria Therapeutics, which adds navenibart to its portfolio [3] - Navenibart is a long-acting Phase 3 therapy for hereditary angioedema, a rare genetic condition causing sudden, painful swelling [3] Market Sentiment - Jim Cramer expressed a negative outlook on BioCryst, advising investors to stay away from the stock, indicating it has been underperforming for a long time [1] - There is a belief that certain AI stocks may offer greater upside potential and carry less downside risk compared to BioCryst [4]

Core Insights - BioCryst Pharmaceuticals has completed the acquisition of Astria Therapeutics, enhancing its leadership in hereditary angioedema (HAE) and supporting long-term growth [1][5] Acquisition Details - The acquisition was valued at approximately $700 million, financed through cash on hand and a financing facility, with BioCryst issuing about 37.3 million shares to Astria's equity holders [5] Product Portfolio Enhancement - BioCryst adds navenibart, a late-stage plasma kallikrein inhibitor in Phase 3 development, which could be the first HAE therapy with every-three and every-six month dosing, improving patient treatment experiences [2][3] - The company now offers both the leading oral therapy (ORLADEYO®) and a potentially best-in-class injectable option, providing optimal choices for individualized patient care [3] Strategic Leadership Changes - Jill C. Milne, Ph.D., co-founder and CEO of Astria, has joined BioCryst's Board of Directors, while John Ruesch has been appointed as Chief Technical Operations Officer, bringing expertise in product development [6] Additional Programs - BioCryst has acquired Astria's early-stage program for atopic dermatitis, STAR0310, and plans to explore strategic alternatives for this program [4]

Financial Performance and Outlook - BioCryst achieved its first full year of profitability in 2025[13] - Preliminary ORLADEYO revenue for 2025 reached $601 million, with $563 million excluding European revenue[14] - The company anticipates ORLADEYO revenue between $625 million and $645 million in 2026[14] - Total revenue for 2026 is projected to be in the range of $635 million to $660 million[14] - Non-GAAP operating expenses for 2026 are expected to be between $380 million and $390 million, and $450 million to $470 million including the Astria acquisition[14] - BioCryst expects to have a cash balance of over $1 billion by 2029[37,52] Strategic Initiatives and Pipeline - BioCryst is acquiring Astria Therapeutics for approximately $700 million TEV to strengthen its HAE portfolio with navenibart[35] - ORLADEYO has a sustainable peak revenue opportunity of $1 billion, with IP protection extending into 2040[20] - The company received FDA approval for ORLADEYO pellet formulation for pediatric patients aged 2 to under 12 with HAE[13] - BCX17725 is being developed as a targeted KLK5 inhibitor for Netherton syndrome, with Phase 1 data from Part 4 expected by the end of 2026[54,69]

Group 1: Artiva Biotherapeutics - Artiva is developing AlloNK, a natural killer (NK) cell-based therapy for autoimmune diseases and cancers, with ongoing clinical trials for conditions like refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) [2][6] - The FDA granted Fast Track designation to AlloNK for refractory RA, highlighting its potential to meet the needs of over 150,000 U.S. patients who have not responded to existing treatments [6] - Recent data from 32 patients treated with AlloNK showed no cases of cytokine release syndrome or neurotoxicity, with all patients achieving complete B-cell depletion by Day 13 [7] Group 2: Market Potential and Analyst Ratings - Wedbush analyst Martin Fan projects a price target of $23 for Artiva, indicating a potential upside of approximately 600% over the next 12 months, supported by a Strong Buy consensus from analysts [10] - The SPDR S&P Biotech ETF (XBI) has increased by about 37% year-to-date, suggesting a growing interest in the biotech sector amid a pause in AI market leadership [4] - Artiva's shares are currently trading at $3.30, which is below its cash value of $5 per share, indicating potential for substantial appreciation as clinical data emerges [10] Group 3: BioCryst Pharmaceuticals - BioCryst has transitioned into a profitable biotech company, driven by its focus on rare diseases and the success of its drug Orladeyo, which generated $159.1 million in net revenue for Q3 2025, a 37% year-over-year increase [14][15] - The FDA recently approved an oral pellet formulation of Orladeyo for pediatric patients, expanding its market reach and potential revenue, with estimates suggesting it could generate $1 billion in peak annual revenue by 2029 [15] - BioCryst's stock is trading at $7.57, with an average price target of $19.27, implying a potential gain of 154% over the next 12 months, supported by a Strong Buy consensus from analysts [19]

ORLADEYO Performance and Outlook - ORLADEYO revenue continues strong growth, with a 37% year-over-year increase in Q3 2025[15] - The FY25 guidance range for ORLADEYO revenue has been raised to $590-600 million[17] - Market research reaffirms a strong outlook for ORLADEYO, with an estimated patient LTP share of 24% in 2034[19] - BioCryst anticipates a sustainable $1 billion peak revenue opportunity for ORLADEYO, with a contribution margin exceeding 80%[14] Astria Acquisition and HAE Portfolio Expansion - BioCryst is set to acquire Astria for approximately $700 million TEV, aiming to strengthen its presence in the HAE market[30] - The acquisition is expected to transform BioCryst's revenue profile, projecting a 10+ year double-digit portfolio CAGR[30] - Post-transaction, BioCryst anticipates maintaining profitability (non-GAAP) and positive cash flow[31] - By 2029, the company expects a cash balance of over $1 billion, providing flexibility for future growth opportunities[32] Pipeline Development - Navenibart presents an opportunity to target 5,000+ patients in the US[34] - BCX17725, a targeted KLK5 inhibitor, is under development for Netherton syndrome, with initial Phase 1 data expected by the end of Q1 2026[59]

Core Insights - BioCryst Pharmaceuticals reported a strong Q3 2025 performance, with ORLADEYO net revenue reaching $159.1 million, a 37% increase year-over-year [1][6][8] - The company raised its FY 2025 revenue guidance for ORLADEYO to between $590 million and $600 million, while lowering non-GAAP operating expense guidance to between $430 million and $440 million [1][17] - BioCryst completed the sale of its European ORLADEYO business, using the proceeds to retire all remaining Pharmakon term debt [1][15] - A definitive agreement was signed to acquire Astria Therapeutics, expected to close in Q1 2026, which will enhance BioCryst's HAE portfolio [1][15] Financial Performance - Total revenues for Q3 2025 were $159.4 million, up 36% from $117.1 million in Q3 2024 [8] - Operating profit for Q3 2025 was $29.6 million, a significant increase of 285% year-over-year, with non-GAAP operating profit at $51.7 million, up 107% [1][11] - Net income for Q3 2025 was $12.9 million, or $0.06 per share, compared to a net loss of $14.0 million, or $0.07 per share, in Q3 2024 [13][27] Market Dynamics - ORLADEYO demand remained strong, with new patient prescriptions slightly exceeding those in Q3 2024 despite new competitors entering the market [4][6] - The U.S. market contributed 89% of global ORLADEYO net revenues in Q3 2025, indicating strong domestic performance [6] Strategic Moves - The sale of the European ORLADEYO business has strengthened the company's financial position and allowed for debt repayment [2][15] - The acquisition of Astria Therapeutics is anticipated to provide opportunities for sustainable growth and profitability in the HAE market [2][15] Research and Development - R&D expenses for Q3 2025 increased to $44.6 million, primarily due to advancements in clinical programs [9] - The company is progressing with clinical trials for BCX17725 and avoralstat, with initial data expected by early 2026 [15]

Core Insights - BioCryst Pharmaceuticals (BCRX) shares increased by 6.1% to $6.81, following a significant trading volume, contrasting with a 17.2% decline over the past month [1][2] Company Developments - The stock surge is attributed to a $700 million acquisition agreement for Astria Therapeutics, which will enhance BCRX's pipeline with navenibart, a long-acting injectable therapy for hereditary angioedema (HAE) [2] - The acquisition is expected to drive double-digit revenue growth, profit accretion, and rapid market adoption, indicating a strategic fit with BCRX's existing commercialization platform [2] Financial Performance Expectations - BioCryst is projected to report quarterly earnings of $0.06 per share, reflecting a year-over-year increase of 185.7%, with revenues anticipated at $161.15 million, a 37.6% rise from the previous year [3] - However, the consensus EPS estimate has been revised down by 4.8% over the last month, which may impact future stock price movements [4] Industry Context - BioCryst is categorized under the Zacks Medical - Drugs industry, where Ironwood Pharmaceuticals (IRWD) also operates, having seen an 8.8% increase in its stock price recently [4] - Ironwood's EPS estimate remains unchanged at $0.09, indicating a significant year-over-year change of 350% [5]