• Total Revenue: $117.1 million for the quarter.
• ORLADEYO Revenue: $116.3 million, nearly 36% year-over-year growth.
• US ORLADEYO Sales: $103.1 million.
• Ex-US ORLADEYO Sales: $13.2 million (11.3% of total ORLADEYO revenue).
• Operating Expenses (excluding non-cash stock compensation): $92.2 million.
• Stock Compensation: $17.2 million.
• GAAP Operating Expenses: $109.4 million.
• Operating Profit (excluding non-cash stock compensation): $24.9 million.
• Operating Profit (including non-cash stock compensation): $7.7 million.
• Cash Position: $351.7 million at the end of the quarter.
• Net Cash Flow: Positive over $13 million for the quarter.
• 2024 Revenue Guidance for ORLADEYO: $430 million to $435 million.
• Total Company Revenue Guidance: $443 million to $448 million.
• Operating Expenses Guidance: $380 million to $390 million.

• Warning! GuruFocus has detected 6 Warning Signs with BCRX.

Release Date: November 04, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) reported a nearly 36% year-over-year growth in ORLADEYO revenue, highlighting strong market performance.
• The company is advancing BCX17725 for Netherton syndrome into clinical trials, addressing an unmet medical need.
• BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) achieved an operating profit for the quarter, excluding non-cash stock compensation.
• The company is on track to submit regulatory submissions for the first oral prophylactic therapy for children with HAE in 2025.
• BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) has a strong cash position and expects to achieve sustained profitability and positive cash flow in the near future.

Negative Points

• The company faces challenges in transitioning patients from free drug to commercial paid therapy, particularly in the Medicare segment.
• There is uncertainty regarding the impact of new injectable prophylactic therapies entering the market in 2025.
• Operating expenses are expected to increase due to costs associated with advancing clinical trials and supporting the HAE community.
• The company anticipates cash flow negativity in Q4 and Q1, despite overall positive financial performance.
• BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) faces potential challenges in achieving its long-term goal of 85% paid therapy rate, particularly with Medicare patients.

Q & A Highlights

Q: Can you discuss the patient growth for ORLADEYO, particularly among those switching from on-demand to prophylactic treatment and those naive to treatment? Which group will drive more growth in the near term and long term? A: Charlie Gayer, Chief Commercial Officer, explained that since the launch, there has been an even split between patients switching from on-demand to prophylactic treatment and those naive to treatment. In the long term, prophylactic switches are expected to drive more growth, but in the near term, the split will remain even.

Q: Regarding Netherton syndrome, what kind of data should we expect next year? Are you looking for biomarker data, signs of efficacy, or safety signals? A: Helen Thackray, Chief Research & Development Officer, stated that they will look for skin penetration, markers of activity, and skin recovery. The goal is to demonstrate that the drug reaches the skin, binds to the target, and has the desired effect, potentially offering a functional cure.

Q: Your 2024 ORLADEYO revenue guidance suggests a slowdown in Q4 sales growth. Does this reflect less benefit from the paid drug uptick or other factors? A: Charlie Gayer noted that the paid rate typically slows in Q4 due to challenges in getting new patients approved for paid therapy at year-end. Additionally, holiday timing affects sales. However, demand remains strong, and they expect continued growth.

Q: Can you provide more details on the transition study for ORLADEYO? What are your expectations for the results, and how will you leverage the data? A: Helen Thackray explained that the Phase 4 study is observational, focusing on how physicians manage the transition to ORLADEYO. The study aims to capture real-world experiences and inform less experienced physicians about managing transitions effectively.

Q: How are you tracking against your target of 200 new patients annually for ORLADEYO, and how might new competition impact the switch opportunity? A: Charlie Gayer confirmed they are on track with patient adds and expect new injectable prophylactics to compete with existing injectables rather than ORLADEYO. The introduction of new therapies may increase discussions about switching, presenting an opportunity for ORLADEYO as a differentiated oral option.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.