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5/6/2026
and welcome to the BioCHRIST first quarter 2026 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one on a touch-tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Nick Wilder. Please go ahead.
Good morning, and welcome to Biochrist's first quarter 2026 Corporate Update and Financial Results conference call. Participating with me today are President and CEO Charlie Geyer, Chief R&D Officer Dr. Sandeep Menon, and Chief Financial Officer Bob Ruggieff. A press release and slide presentation about today's news are available on our Investor Relations website. Today's call contains forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance, or achievements to be materially different from any future results or performance expressed or implied in this presentation. For additional information, including a detailed discussion of these risks, please refer to slide two of the presentation. In addition, today's conference call includes non-GAAP financial measures. For a reconciliation of these non-GAAP financial measures against the most directly comparable GAAP financial measure, please refer to the earnings press release available on our investor relations website. I'd now like to turn the call over to Charlie. Thanks, Nick.
2026 is off to a very good start for Biocrist. marked by strong execution on our commercial and development programs, the smooth integration of Astrea Therapeutics and discipline management of our finances. Orladeo net revenue of $148.3 million for the quarter was right in line with our expectations, and monthly new patient prescriptions have tracked slightly ahead of 2025 averages. The pediatric indication launch is just beginning, but early signals confirm the need for oral prophylaxis for kids with HAE. We have received prescriptions for each of the four product strengths of Orlodeo pellets, which demonstrates that even younger children need prophylaxis. We are committed to bringing oral prophy to the many kids who need it. We have also recently discovered a manufacturing issue that will delay the first product fulfillment and our team is working closely with our manufacturing partner to identify the root cause. We expect to have more information about the product readiness later this quarter, and we do not expect this delay to affect our revenue guidance for 2026. We look forward to bringing Orlodeo to the kids who need it as soon as possible. The pediatric indication is exciting, but it does not distract our team from driving new patient demand for Orlodeo capsules. We are pleased that new prescription demand for ages 12 and up remains consistent with our quarterly averages since launch, despite new competition. Physicians and patients continue to trust Orladeo as an effective and proven option for HA prophylaxis. Turning to our pipeline development, progress on the pivotal Alpha Orbit trial for NovenaBART has exceeded our expectations. Enrollment will be completed by the end of next month, And at approximately 145 enrolled patients, Alpha Orbit will be the largest pivotal trial ever for HA prophylaxis. The speed of enrollment is a testament to our team's execution, as well as the attractiveness of Nevanobar's profile. Our phase one study for BCX17725 and Netherton syndrome is also hitting its stride. Investigator enthusiasm has been strong, Patients have started dosing, and we are on track to have proof-of-concept data by the end of the year in this high-need rare disease. I am thrilled that Dr. Sandeep Menon has joined us as Chief R&D Officer last month. We're making great progress in our pipeline, and adding Sandeep makes us stronger. He has a track record of disciplined and successful drug development, and he shares our vision of building great value through serving rare disease patients. I'll turn it over to Sandeep to introduce himself.
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