Latest news with #BioCrystPharmaceuticalsInc
San Francisco Chronicle
6 days ago
- Business
- San Francisco Chronicle
BioCryst: Q2 Earnings Snapshot
DURHAM, N.C. (AP) — DURHAM, N.C. (AP) — BioCryst Pharmaceuticals Inc. (BCRX) on Monday reported second-quarter net income of $5.1 million, after reporting a loss in the same period a year earlier. On a per-share basis, the Durham, North Carolina-based company said it had profit of 2 cents. Earnings, adjusted for non-recurring costs, came to 15 cents per share. The results exceeded Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for earnings of 3 cents per share. The drugmaker posted revenue of $163.4 million in the period, also topping Street forecasts. Four analysts surveyed by Zacks expected $148.9 million. BioCryst shares have climbed roughly 6% since the beginning of the year. The stock has risen 13% in the last 12 months. _____
Yahoo
06-05-2025
- Business
- Yahoo
BioCryst Pharmaceuticals Inc (BCRX) Q1 2025 Earnings Call Highlights: Strong ORLADEYO Sales ...
Total Revenue: $145.5 million for the quarter. ORLADEYO Revenue: $134.2 million, with $120.2 million from the US. Operating Expenses (excluding stock-based compensation): $102.9 million, up from $93.6 million in the same quarter last year. Operating Profit: $21.2 million for the first quarter of 2025. Net Income: Slightly positive for the quarter. Cash Position: $317 million at the end of the quarter. Debt Reduction: Paid down $75 million, reducing outstanding debt to $249 million. Annual Revenue Guidance for ORLADEYO: Raised to between $580 million and $600 million, representing 33% to 37% growth over last year. Non-GAAP Operating Expense Guidance: $440 million to $450 million for the year. Warning! GuruFocus has detected 6 Warning Signs with BCRX. Release Date: May 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) reported a strong first quarter with revenue of $145.5 million, driven by ORLADEYO sales. The company raised its annual revenue guidance for ORLADEYO to between $580 million and $600 million, indicating 33% to 37% growth over the previous year. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) achieved a significant improvement in the paid rate for ORLADEYO, reaching 84%, which was expected to take three years but was accomplished in four months. The company is on track to be profitable on a full-year basis in 2025, a year earlier than previously planned. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) paid down $75 million of its debt, reducing outstanding debt to $249 million and saving approximately $23 million in interest payments over the life of the debt. The typical revenue jump in Q2 will be less pronounced than in prior years due to the accelerated revenue capture in Q1. Operating expenses increased to $102.9 million, up from $93.6 million in the same quarter last year, driven by commercial expansion and support activities. The company faces challenges in conducting clinical trials for rare diseases like Netherton syndrome due to the lack of existing therapies and organized patient advocacy. The path to achieving $1 billion in global revenue by 2029 for ORLADEYO is still dependent on capturing more patients and maintaining growth momentum. The pediatric launch of ORLADEYO, while promising, has not yet been quantified in terms of revenue impact, and the uptake dynamics remain uncertain. Q: Can you provide insights into the potential pediatric launch for ORLADEYO and its impact on the market? A: Charles Gayer, Chief Commercial Officer, explained that there are approximately 500 pediatric HAE patients in the US, with at least 200 potentially suitable for prophylactic therapy. The introduction of an oral option like ORLADEYO could change the treatment landscape, as there is no preference for injectables among children. The expectation is that ORLADEYO will become the market leader due to its ease of administration compared to injectables. Q: What are the expectations for the DME program's first readout, and what would be considered a successful outcome? A: Helen Thackray, Chief Research & Development Officer, stated that the focus is on safety, tolerability, and the effect on retinal thickness. The goal is to observe a reduction in retinal edema, with preclinical data suggesting a quick response. A significant reduction in edema would be a positive indicator for the program's success. Q: How did BioCryst achieve such a significant improvement in the paid rate for ORLADEYO, and is this sustainable? A: Charles Gayer highlighted that two-thirds of the improvement was due to the Inflation Reduction Act, which helped Medicare patients afford their prescriptions. The commercial segment also saw improvements due to better preparation and real-world evidence supporting ORLADEYO's efficacy. The current paid rate is expected to be sustainable, with further incremental improvements anticipated. Q: With profitability pulled forward, how does this impact BioCryst's investment strategy, particularly for the early-stage pipeline? A: Jon Stonehouse, CEO, noted that the programs are already fully funded to proceed as quickly as possible. The company is focused on cleaning up the balance sheet, as evidenced by the recent $75 million debt paydown, and will continue to look at similar opportunities as cash flow improves. Q: What are the expectations for the Netherton syndrome program, and what are the key milestones? A: Helen Thackray explained that the program is designed to address the fundamental pathology of Netherton syndrome. The Phase 1 trial will assess drug levels in the epidermis and clinical impact, with initial data expected by year-end. The goal is to see normalization of the skin and reduction in itch, with potential dose escalation if necessary. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
25-02-2025
- Business
- Yahoo
BioCryst Pharmaceuticals Inc (BCRX) Q4 2024 Earnings Call Highlights: Strong ORLADEYO Revenue ...
ORLADEYO Revenue Growth: 34% year-over-year increase for 2024. Total Revenue for Q4 2024: $131.5 million. ORLADEYO Revenue for Q4 2024: $124.2 million. Total Revenue for Full Year 2024: $450.7 million. ORLADEYO Revenue for Full Year 2024: $437.7 million. Non-GAAP Operating Profit for 2024: Over $60 million. Operating Expenses for Q4 2024: Approximately $115 million (excluding non-cash stock compensation). Operating Expenses for Full Year 2024: $388 million (excluding non-cash stock compensation). Cash at Year-End 2024: Approximately $343 million. Net Cash Utilization for Q4 2024: $8.4 million. 2025 ORLADEYO Revenue Guidance: Raised to $535 million to $550 million. 2025 Total Revenue Guidance: Adjusted to $560 million to $575 million. Warning! GuruFocus has detected 7 Warning Signs with BCRX. Release Date: February 24, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) reported a 34% year-over-year growth in ORLADEYO revenue for 2024, indicating strong market performance. The company achieved a non-GAAP operating profit of over $60 million, which was three times larger than planned, showcasing effective financial management. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) is advancing its pipeline with promising clinical trials for BCX17725 for Netherton Syndrome and Avoralstat for Diabetic Macular Edema. The company is on track to file an NDA for ORLADEYO for pediatric use, expanding its market potential to children aged 2 to 11. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) raised its ORLADEYO revenue guidance for 2025 to $535 million to $550 million, reflecting strong demand and favorable impacts from the Inflation Reduction Act for Medicare patients. The company faces uncertainty around future government funding for RAPIVAB, which could impact revenue streams. There is a potential headwind from foreign exchange rates, particularly affecting revenue from the European Union. BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) anticipates flat to slightly down revenue in Q1 2025 due to the reauthorization season and gross-to-net impacts. The company acknowledges that the Netherton Syndrome market is underdiagnosed, which could pose challenges in patient identification and market penetration. Despite the positive outlook, the company remains cautious about the variability in ex-US demand and the impact of distributor shipment timing on quarterly results. Q: Can you provide more details on the expected timeline for Netherton Syndrome data and what constitutes positive data? A: Helen Thackray, Chief Research & Development Officer: We expect to have data this year. For Netherton Syndrome, we only need data from a small number of patients to confirm the mechanism. We're looking for the drug's effect on KLK5 activity in the skin, leading to healing. If successful, we could move quickly into pivotal studies, potentially with a single pivotal trial supported by this year's data. Q: What is the current status of ORLADEYO's paid patient proportion, especially within Medicare? A: Charles Gayer, Chief Commercial Officer: We ended last year with 73.5% paid across our patient base. For Medicare, it was lower, around 55-56%. We expect this to improve significantly due to the Inflation Reduction Act, potentially reaching 80% by the end of the quarter. Q: How does the pediatric formulation of ORLADEYO compare in terms of tolerability and regulatory expectations? A: Helen Thackray, Chief Research & Development Officer: The pediatric oral granules show good tolerability and similar efficacy to adults. Regulatory approval will follow a pediatric extrapolation approach, matching safety and exposure to extend labeling from adults to children. We are on track with the FDA and EMA for this process. Q: What are the expectations for ORLADEYO's international demand in 2025, considering the Q4 uptick? A: Charles Gayer, Chief Commercial Officer: We see growing confidence in ORLADEYO internationally, with transformative confidence in markets like the UK and early confidence in Italy. Despite FX headwinds, we expect continued growth, although the percentage of ex-US revenue might be slightly deflated due to strong US growth. Q: How is BioCryst addressing the underdiagnosis of Netherton Syndrome? A: Charles Gayer, Chief Commercial Officer: We are expanding our efforts to identify patients, focusing on distinctive features like bamboo hair. We plan to educate the market and engage with the patient community to improve diagnosis and awareness as we move into clinical trials. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
