BioCryst Pharmaceuticals, Inc. (BCRX) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlighted strong financial performance with record revenue growth and operating profit, coupled with strategic developments like the Astria acquisition and raised ORLADEYO guidance. The Q&A session revealed no major negative sentiments, though management was somewhat vague on certain timelines. The market's reaction is likely positive, driven by raised guidance, strong cash position, and strategic partnerships, despite some uncertainties. Given the company's small-cap status, the stock is expected to react positively, within the range of 2% to 8%.
Key Financial Performance
Full-year ORLADEYO revenue $601.8 million, up 38% year-over-year (43% excluding the Europe business sale). The increase was attributed to strong commercial execution and differentiation of the product as an oral option.
Non-GAAP 2025 total revenue Increased 45% year-over-year. This growth was driven by higher patient volume and progress on paid shipments, supported by the divestiture of the European business.
Non-GAAP ORLADEYO revenues Increased by approximately $169 million or 43% year-over-year. The growth was due to superior real-world evidence generation capabilities and strong commercial execution.
Non-GAAP operating profit $214 million, an increase of 198% year-over-year. This was the highest in BioCryst's history, driven by strong top-line growth and disciplined cost management.
Sales and marketing expenses $144 million on a non-GAAP basis, increased due to prelaunch costs for pediatrics, higher specialty distribution fees, and incentive compensations. However, the ROI on ORLADEYO net sales was approximately 4x for every dollar invested.
Liquidity position $337.5 million in cash and investments on hand at the end of 2025. This was bolstered by a $400 million financing facility with Blackstone Life Sciences.
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Operating Highlights
ORLADEYO revenue: Delivered full-year ORLADEYO revenue of $601.8 million, up 38% year-on-year and 43% excluding the Europe business sold in October.
HAE portfolio expansion: Expanded HAE portfolio with the acquisition of Astra Therapeutics and launched ORLADEYO pellets for kids aged 2 to under 12.
Navenibart development: Navenibart is in late-stage development, targeting injectable prophylaxis for HAE patients with dosing every 3 or 6 months.
BCX17725 program: Early-stage program in Netherton syndrome with clinical data expected by the end of the year.
HAE market segmentation: Positioned HAE market as structurally segmented based on biology, patient preference, and real-world experience, rather than a winner-take-all market.
Pediatric HAE treatment: FDA approval for ORLADEYO oral pellets for children aged 2 to under 12, addressing unmet needs in younger kids.
Revenue growth: Non-GAAP 2025 total revenue increased 45% year-on-year, with ORLADEYO revenues up 43%.
Profitability: Non-GAAP operating profit reached $214 million, a 198% increase year-on-year.
Cost management: R&D costs slightly decreased in 2025, with plans to increase in 2026 for ongoing trials and development activities.
Capital allocation: Focused on ensuring every dollar deployed drives long-term value creation, with disciplined R&D spending and high ROI opportunities.
Financing and liquidity: Entered a $400 million financing facility with Blackstone Life Sciences, ending 2025 with $337.5 million in cash and investments.
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Risk or Challenges
Regulatory hurdles: The company is awaiting marketing authorization applications in other major regions for ORLADEYO oral pellets for children, which could face delays or rejections.
Supply chain disruptions: Potential challenges in scaling production and distribution for new products like ORLADEYO pellets and Navenibart, especially as the company expands globally.
Economic uncertainties: The company’s financial performance could be impacted by broader economic conditions, which may affect patient access and healthcare spending.
Strategic execution risks: The company’s ability to maintain profitability and achieve blockbuster potential for ORLADEYO depends on disciplined capital allocation and successful execution of its growth strategy.
Competitive pressures: The HAE market is structurally segmented, and new entrants could challenge BioCryst’s market share despite its differentiated product portfolio.
Clinical trial risks: The success of ongoing trials, such as the pivotal Phase III trial for Navenibart, is critical for future growth and could face recruitment or efficacy challenges.
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Guidance & Outlook
Revenue Expectations: BioCryst expects full-year 2026 ORLADEYO revenues to be between $625 million and $645 million, representing approximately 13% growth over 2025 revenues adjusted for Europe.
R&D Costs: R&D costs are anticipated to increase in 2026 due to the completion of the ongoing Phase III trial and BLA-enabling CMC activities for Navenibart. These costs are expected to decrease beyond 2026.
Sales and Marketing Expenses: Sales and marketing expenses are expected to remain stable and predictable, with a high ROI as the company drives ORLADEYO toward its blockbuster potential and prepares for potential approval of Navenibart.
Pipeline Development: The Navenibart pivotal Phase III trial is expected to complete enrollment by mid-2026, with results anticipated to confirm its potential as a high-efficacy injectable dosed every 3 or 6 months. Additionally, the BCX17725 program in Netherton syndrome aims to generate clinical data by the end of 2026.
Market Trends and Growth: BioCryst sees durable revenue growth driven by its HAE portfolio, including ORLADEYO capsules, ORLADEYO pellets for children, and Navenibart. The company aims to address the full spectrum of patient needs in HAE prophylaxis and maintain its leadership in the market.
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Shareholder Return Plan
buybacks: Concurrent with the closing of the Astria acquisition, we entered into a highly attractive $400 million financing facility with Blackstone Life Sciences, a financial partner that is aligned with our vision of growth. With the sustained momentum, coupled with the added benefit that now, for the next 2 years, we will be able to utilize our prior period tax NOLs, we will be in a very strong cash flow-generating position. This will afford us optionality to evaluate a wide array of capital allocation strategies that reinforce durable value creation, be it M&A, debt paydown, or buybacks.
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Key Q&A
Q:Could you talk a little bit more about the timing for the regulatory submission of Navenibart by year-end '27? Does that assume Phase III data still arriving by early '27? What steps have to occur between top-line data and submission?
A:The regulatory submission for Navenibart is on track for filing by the end of 2027, with approval expected by late 2028. The timing is driven by the need for 12 months of safety data, which will be available by mid-2027. The data shows a 92% mean reduction in attack rate for the 3-month dose and 90% for the 6-month dose, with patients experiencing fewer than two attacks per year and reduced severity.
Q:Do you have any sense of how to predict who would be a super responder to ORLADEYO? How do you envision positioning Navenibart in relation to ORLADEYO?
A:There is no way to predict super responders to ORLADEYO other than for patients to try it. ORLADEYO is positioned for patients who prefer oral prophylaxis, while Navenibart is targeted at the 5,000 patients on injectables who could benefit from less frequent dosing. Navenibart will be launched with an auto-injector, offering 3-month and 6-month dosing options. There is no evidence of anti-drug antibodies (ADA) impacting efficacy or safety in Phase II trials.
Q:Are you going to release Part 3 and 4 data for Neethererton at the same time? Could you talk about disease severity and variability at baseline?
A:The plan is to release Part 3 and 4 data together, as Part 3 will only have 2-3 patients. Disease severity in Netherton syndrome varies, but patients with obvious illness are being selected for trials. Recruitment is not expected to be an issue as investigators are eager to enroll patients.
Q:Can you provide more specifics on how you would provide updates and disclosure around the Navenibart program? What is your strategy to potentially get the FDA to accelerate the timelines?
A:Updates on the Navenibart program will likely occur once the pivotal study is fully enrolled. To accelerate timelines, elements of the BLA will be written in advance, but clarity on timing will depend on the last patient's first visit and discussions with the FDA at a pre-BLA meeting.
Q:Are you seeing any impact from recent new entrants, including oral acute therapies, on ORLADEYO?
A:There has been no impact on ORLADEYO from new prophylactic entrants or oral acute therapies. Patients who prefer oral prophylaxis continue to choose ORLADEYO, while injectables compete among themselves. There is potential for a tailwind from patients preferring an all-oral combination, but it is too early to confirm.
Q:What levers will you be looking at most closely in 2026 for ORLADEYO? How should we think about the pediatric pellet formulation launch?
A:The key performance indicator for 2026 is net patient growth, with a target of 150 net new patients per year to reach $1 billion in revenue by 2029. The pediatric pellet formulation launch is expected to encourage diagnosis and treatment in children, but its contribution to 2026 revenue is expected to be small initially.
Q:Can you give an idea of how the reauthorization process for ORLADEYO is progressing this year? What should we expect for Q1 revenue?
A:The reauthorization process is progressing well, but Q1 revenue is expected to be slightly down compared to Q4 due to higher free product distribution and co-pay support. Revenue is expected to rebound in Q2.
Q:Given the EU business sale, are you willing to split your 2026 guidance for U.S. and ex-U.S. contributions?
A:The majority of the 2026 guidance ($625 million to $645 million) will come from the U.S., with over 90% of revenue expected from the U.S. business after the EU business sale.
Q:Review of Unclear Management Responses
A:Management avoided providing a clear answer on the strategy to accelerate FDA timelines for Navenibart, stating that clarity would depend on future events such as the last patient's first visit and pre-BLA meeting discussions. Additionally, they did not provide specific details on the potential tailwind from oral acute therapies or the exact split of U.S. and ex-U.S. contributions in 2026 guidance.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
BCX
HAE option
HAE portfolio
HAE prophylaxis
Navenibart
Netherton syndrome
Phase trial
Quad AI
administration
application
attack control
attack rate
biology
cohort study
cohort week
commercialization
differentiation
efficacy
endpoint
month dosing
need patient
patient investigator
pellet kid
quality
rate month
reduction baseline
responder
safety study
score
term safety
time
value creation
volunteer
BCRX Transcript
BioCryst Pharmaceuticals, Inc. (BCRX) Q4 2025 Earnings Call Transcript
Positive2-26
The earnings call highlighted strong financial performance with record revenue growth and operating profit, coupled with strategic developments like the Astria acquisition and raised ORLADEYO guidance. The Q&A session revealed no major negative sentiments, though management was somewhat vague on certain timelines. The market's reaction is likely positive, driven by raised guidance, strong cash position, and strategic partnerships, despite some uncertainties. Given the company's small-cap status, the stock is expected to react positively, within the range of 2% to 8%.
BioCryst Pharmaceuticals, Inc. (BCRX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
BioCryst Pharmaceuticals, Inc. (BCRX) Presents at Jefferies London Healthcare Conference 2025 Transcript
Neutral11-24
BioCryst Pharmaceuticals, Inc. (BCRX) Q3 2025 Earnings Call Transcript
Positive11-3
The earnings call summary indicates strong financial performance, with a significant increase in ORLADEYO revenue and improved profitability. Despite some uncertainties in the preclinical programs, management's optimistic guidance and strategy for pediatric HAE approval, coupled with a robust financial position post-European business sale, suggest a positive outlook. The market cap indicates a small-cap stock, which typically reacts more strongly, supporting a positive prediction.
BCRX Slides
BioCryst full year 2025 slides: record profit, injectable expansion2026-02-26
BioCryst Q3 2025 slides: ORLADEYO growth strong at 37%, Astria acquisition announced2025-11-03
BioCryst Q2 2025 slides: ORLADEYO demand surges, profitability accelerates2025-08-04
BioCryst Q1 2025 slides: ORLADEYO sales surge, guidance raised2025-05-05
BCRX Report
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