RESEARCH TRIANGLE PARK, N.C., May 16, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new real-world evidence on the use of oral, once-daily ORLADEYO® (berotralstat) in adolescents and people with severe HAE showing significant and sustained reductions in HAE attack rates through 18 months of follow-up after beginning treatment with ORLADEYO in both patient populations. The real-world evidence was presented in two posters at the 2025 International Society for Pharmacoe ...

Summary of BioCryst Pharmaceuticals (BCRX) Conference Call Company Overview - **Company**: BioCryst Pharmaceuticals (BCRX) - **Event**: 2025 Conference on May 14, 2025 - **Speakers**: John Stonehouse (CEO), Charlie Geier (Chief Commercial Officer) Key Industry Insights - **Impact of Executive Orders**: The recent executive order regarding most favored nation status may affect BioCryst, but details are still unclear. The company is monitoring the situation closely [3][4][5] - **Tariff Position**: BioCryst feels well-positioned regarding tariffs due to low cost of goods for Orlodea and a redundant supply chain in both Europe and the US [8] Financial Performance - **Q1 Results**: BioCryst reported a 51% year-over-year growth in Q1, driven by strong demand and an increase in the paid rate for Orlodea [13][14] - **Paid Rate Increase**: The paid rate for patients has jumped to 84%, with Medicare segment reaching 89%, attributed to the IRA making drugs more affordable [15] - **Sales Guidance**: The company is confident in achieving at least $800 million in US sales, with a global sales target of $1 billion by 2029 [27][29] Product Insights - **Orlodea**: The product has shown strong market demand and patient retention due to its efficacy and convenience. Patients prefer Orlodea for its oral administration and low attack rates [18][19][20][22] - **Market Stickiness**: The stickiness of the market is attributed to patient satisfaction with Orlodea, making it difficult for new competitors to gain traction [20] Pipeline Developments - **BCX1775**: The company is advancing its first biologic for Netherton Syndrome, aiming to control KLK activity and improve skin turnover [36][38] - **Avorostat**: This drug is being explored for diabetic macular edema (DME), with a focus on its potential to address unmet needs in patients who do not respond to VEGF therapies [68][70] Clinical Trials and Future Outlook - **Clinical Trials**: BioCryst is conducting studies for both BCX1775 and Avorostat, with expectations for data by the end of the year. The company is optimistic about the potential for accelerated pathways to market if results are favorable [61][66][78] - **Market Potential**: The company believes that the market for Netherton Syndrome could grow significantly if a targeted therapy is introduced, similar to the growth seen in other rare diseases [56] Conclusion - BioCryst Pharmaceuticals is positioned for strong growth with its current product offerings and pipeline developments. The company is actively monitoring regulatory changes and market dynamics while focusing on delivering effective therapies for rare diseases.

Group 1: BioCryst Pharmaceuticals, Inc. (BCRX) - BioCryst has a Zacks Rank 1 and the Zacks Consensus Estimate for its current year earnings increased by 285.7% over the last 60 days [1] - The company's shares gained 15% over the last three months, while the S&P 500 declined by 7.2% [1] - BioCryst possesses a Momentum Score of A [1] Group 2: WidePoint Corporation (WYY) - WidePoint has a Zacks Rank 1 and the Zacks Consensus Estimate for its current year earnings increased by 108.3% over the last 60 days [2] - The company's shares gained 35.7% over the last three months, compared to the S&P 500's decline of 7.2% [2] - WidePoint possesses a Momentum Score of B [2] Group 3: Rambus Inc. (RMBS) - Rambus has a Zacks Rank 1 and the Zacks Consensus Estimate for its current year earnings increased by 3.9% over the last 60 days [3] - The company's shares gained 11.6% over the past month, while the S&P 500 advanced by 6.9% [3] - Rambus possesses a Momentum Score of B [3]

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Core Viewpoint - BioCryst Pharmaceuticals (BCRX) is positioned as a strong investment opportunity due to its improving earnings outlook and analysts' increasing earnings estimates [1][2]. Earnings Estimates - Analysts are optimistic about BioCryst's earnings prospects, leading to higher estimates that are expected to positively impact the stock price [2]. - The current quarter's earnings estimate is projected at $0.02 per share, reflecting a significant increase of +133.33% from the previous year [5]. - For the full year, the earnings estimate is expected to be $0.13 per share, representing a change of +130.95% from the prior year [6]. Estimate Revisions - Over the last 30 days, the Zacks Consensus Estimate for BioCryst has increased by 158.18%, with three estimates moving higher and no negative revisions [5]. - The consensus estimate for the current year has seen a remarkable increase of 341.56% during the same period [7]. Zacks Rank - BioCryst currently holds a Zacks Rank 2 (Buy), indicating strong agreement among analysts in revising earnings estimates upward [8]. - Stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) have historically outperformed the S&P 500 [8]. Stock Performance - BioCryst shares have appreciated by 48.9% over the past four weeks, suggesting strong investor confidence in the company's earnings growth prospects [9].

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Summary: BioCryst Pharmaceuticals (BCRX) - BCRX currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for potential outperformance in the market [3] - Over the past week, BCRX shares increased by 6.44%, significantly outperforming the Zacks Medical - Drugs industry, which rose by 0.39% [5] - In a longer timeframe, BCRX's monthly price change is 48.89%, compared to the industry's 6.21% [5] - Over the last quarter, BCRX shares rose by 14.81%, and they have increased by 97.65% over the past year, while the S&P 500 saw movements of -6.34% and 9.94%, respectively [6] - The average 20-day trading volume for BCRX is 5,448,160 shares, indicating strong trading activity [7] Earnings Outlook - In the past two months, 6 earnings estimates for BCRX have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from -$0.07 to $0.13 [9] - For the next fiscal year, 6 estimates have also moved upwards without any downward revisions [9] Conclusion - Considering the strong momentum indicators and positive earnings outlook, BCRX is identified as a 2 (Buy) stock with a Momentum Score of A, making it a potential candidate for near-term investment [11]

Core Viewpoint - BioCryst Pharmaceuticals (BCRX) has shown a significant price increase of 48.9% over the past four weeks, with a mean price target of $16.25 indicating a potential upside of 61.2% from the current price of $10.08 [1] Price Targets and Analyst Estimates - The mean estimate consists of 12 short-term price targets with a standard deviation of $5.66, indicating variability among analysts; the lowest estimate is $8 (20.6% decline), while the highest is $30 (197.6% increase) [2] - Analysts' price targets can often mislead investors, as empirical research shows that they rarely indicate the actual price direction of a stock [7] - A low standard deviation in price targets suggests a high degree of agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [9] Earnings Estimates and Analyst Consensus - There is growing optimism among analysts regarding BCRX's earnings prospects, as indicated by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [11] - The Zacks Consensus Estimate for the current year has increased by 341.6% over the past month, with five estimates rising and no negative revisions [12] - BCRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential upside [13]

BioCryst Pharmaceuticals (BCRX) Conference Call Summary Company Overview - BioCryst Pharmaceuticals is a commercial stage and profitable biotech company focused on developing medicines for rare diseases, particularly hereditary angioedema (HAE) [3][4] - The company's commercial product, Orlodeo, is a once-daily oral pill for HAE patients, which has been on the market for about five years and is projected to generate peak sales of $1 billion [4][6] Financial Performance - BioCryst raised its sales guidance for Orlodeo to $580 to $600 million for the current year [5][27] - The company is in a strong cash position and expects to be profitable on a full-year basis moving forward [6] Product Success and Market Dynamics - Orlodeo's success is attributed to its efficacy and convenience, with approximately 60% of patients experiencing significant efficacy [9][10] - The product has seen strong demand, with about half of its business coming from patients switching from injectable therapies [10][11] - Market research indicates that patients require compelling reasons to switch therapies, which has contributed to Orlodeo's steady growth [22][23] Pipeline Developments - BioCryst has two additional programs in clinical trials: one for Netherton syndrome (Phase 1) and another for diabetic macular edema (DME) [5][6] - The company anticipates data from both programs by the end of the year [50][66] Netherton Syndrome - Netherton syndrome is a severe rare disease with no current treatment options, affecting skin turnover and leading to significant health risks [50][51] - BioCryst's product, BCX 17725, aims to replace the missing protein that regulates skin turnover [51][52] - The estimated patient population for Netherton syndrome in the U.S. is between 3,000 to 5,000 [55] Diabetic Macular Edema (DME) - Avorostat, initially developed for HAE, is being repurposed for DME using a suprachoroidal delivery method [60][61] - The company is set to begin patient enrollment for the DME trial in Australia [62] Market Research and Competitive Landscape - BioCryst employs comprehensive market research, including Monte Carlo simulations, to accurately forecast sales and understand market dynamics [18][19] - The company maintains a competitive edge in the oral prophylactic space against injectable therapies, with Orlodeo and Tekxaro being market leaders [20][21] Future Outlook - The company aims to achieve $800 million in U.S. sales by adding approximately 200 new patients annually and achieving an 85% reimbursement rate [30][32] - The pediatric formulation of Orlodeo is expected to significantly impact the market, with an estimated 500 affected children in the U.S. [38][39] - BioCryst plans to continue building its cash balance and has already paid off $75 million of its debt early this quarter [68] Conclusion - BioCryst Pharmaceuticals is positioned for continued growth with a strong commercial product, a promising pipeline, and a solid financial outlook, making it a notable player in the biotech sector focused on rare diseases [69]

Financial Performance - Revenues for Q1 2025 were $145,534, a 57% increase compared to $92,761 in Q1 2024[22] - Net income for Q1 2025 was $32, compared to a net loss of $35,379 in Q1 2024[22] - Total revenues for the three months ended March 31, 2025, were $145,534,000, a 57% increase from $92,761,000 in the same period of 2024[37] - Net product sales for ORLADEYO amounted to $143,787,000 for the three months ended March 31, 2025, compared to $89,272,000 in the prior year, reflecting a 61% growth[37] - The Company recorded a segment net income of $32,000 for Q1 2025, a significant recovery from a net loss of $35,379,000 in Q1 2024[178] - Total revenues for the three months ended March 31, 2025, were $145.5 million, up from $92.8 million for the same period in 2024, driven by a $45.4 million increase in ORLADEYO net revenue[212] Expenses - Research and development expenses decreased to $37,270 from $46,493 in Q1 2024, a reduction of approximately 20%[22] - Selling, general and administrative expenses increased to $82,469 from $59,491, a rise of approximately 38%[22] - The Company incurred $82,469,000 in selling, general and administrative expenses for Q1 2025, up from $59,491,000 in Q1 2024[178] - Stock-based compensation expense increased from $13,652,000 in Q1 2024 to $21,368,000 in Q1 2025, an increase of about 56.7%[152] - Selling, general and administrative expenses for Q1 2025 were $82.5 million, up from $59.5 million in Q1 2024, reflecting increased commercial expenses and stock-based compensation[217] Assets and Liabilities - Total current assets decreased to $409,977 from $421,968 as of December 31, 2024[21] - Total liabilities decreased to $931,974 from $966,354 as of December 31, 2024[21] - Cash and cash equivalents increased to $105,190 from $104,713 as of December 31, 2024[21] - The Company reported a total stockholders' deficit of $451,927 as of March 31, 2025, improved from $475,934 as of December 31, 2024[21] - The Company had investments with a total estimated fair value of $210,450,000 as of March 31, 2025, down from $236,460,000 at December 31, 2024[110] Revenue Recognition and Receivables - Trade receivables are primarily due from specialty pharmacy customers in the U.S. and third-party distributors, with standard payment terms of 30 to 90 days[58] - The Company recognizes revenue from license fees and royalties when the earnings process is complete, with royalties based on licensees' net sales of covered products[48][50] - The Company evaluates trade receivables for estimated losses and provides reserves based on current economic conditions and historical collection experience[60] - The Company recorded approximately 84% and 87% of total net revenues from sales of ORLADEYO through a single specialty pharmacy for the three months ended March 31, 2025 and 2024, respectively[94] Inventory and Production - The Company’s inventory primarily consists of ORLADEYO and peramivir, valued at the lower of cost or estimated net realizable value[61] - Total inventory as of March 31, 2025, was $31,970,000, slightly up from $31,274,000 at December 31, 2024[115] - The Company expenses costs related to production of pre-launch inventory as research and development expense until regulatory approval is received, after which inventory costs are capitalized[64] - The Company has significant judgment in determining the need for valuation reserves for inventory, which includes excess, obsolete, or unmarketable inventory[63] Debt and Financing - The Company has entered into royalty purchase agreements with RPI and OMERS, totaling $275,000,000 in cash for future royalty payments[116] - As of March 31, 2025, the carrying value of royalty financing obligations was approximately $500,918, with effective interest rates of 21.6% for the 2020 RPI Agreement and 10.0% for the OMERS Agreement[127] - The Company had total borrowings of $300,000 under the Pharmakon Loan Agreement as of March 31, 2025, with interest expense of $9,153 for the quarter[138] - The Pharmakon Loan Agreement allows for quarterly interest-only payments until the maturity date of April 17, 2028, with an effective interest rate of 12.31% for the three months ended March 31, 2025[134] - The Company incurred debt fees and issuance costs of $11,147 associated with the Tranche A Loan, which are being amortized over the term of the loan[141] Clinical Development and Regulatory - The FDA has cleared the investigational new drug application for BCX17725, enabling clinical trials to enroll patients in the United States[209] - The company expects to submit a new drug application to the FDA in 2025 to expand the ORLADEYO label to children aged 2 to 11[206] - The ongoing APeX-P clinical trial is assessing an oral granule formulation of ORLADEYO in pediatric patients aged 2 to 11[189] - The Company anticipates initial clinical data from the avoralstat program targeted by the end of 2025[210] Market and Competitive Landscape - The Company is seeking to defend its intellectual property rights against Annora Pharma's ANDA filing for a generic version of ORLADEYO, which could impact future revenues[179] - ORLADEYO is projected to reach a global peak of $1 billion in annual net revenues, with approximately 80% expected from the United States[190] - The percentage of U.S. HAE patients preferring an oral prophylaxis therapy increased to 70% in 2025, up from 50% in 2023[207]

Core Insights - BioCryst Pharmaceuticals reported first-quarter sales of $145.50 million, a 52.7% increase year over year, surpassing the consensus estimate of $126.87 million [1] - The growth was primarily driven by Orladeyo's net revenue of $134.2 million, which increased by $45.3 million year over year, compared to $88.9 million in the same quarter of the previous year [1] Financial Performance - The net income for the first quarter of 2025 was $32 thousand, or $0.00 per share, a significant improvement from a net loss of $35.4 million, or $0.17 per share, in the first quarter of 2024 [2] - Operating income for the first quarter of 2025 was $21.2 million, compared to an operating loss of $14.5 million for the same period in 2024 [3] - Non-GAAP operating income, excluding stock-based compensation, was $42.6 million for the first quarter of 2025, compared to a non-GAAP operating loss of $0.8 million in the first quarter of 2024 [3] Guidance and Outlook - BioCryst raised its 2025 revenue outlook for Orladeyo to between $580 million and $600 million, up from the previous estimate of $535 million to $550 million [4] - The company now anticipates full-year 2025 operating expenses to be between $440 million and $450 million, an increase from the prior guidance of $425 million to $435 million [4] - The expectation for achieving net income and positive cash flows has been accelerated to 2025, previously anticipated for 2026 [5] - Positive cash flow is defined as the improvement in cash and equivalents from year-end 2024 to year-end 2025, excluding a $75 million prepayment made in April 2025 [5] Market Reaction - Following the announcement, BCRX stock closed up by 23.50% to $11.03 [5]