2/26/2026

speaker
Operator
Conference Operator

Good day and welcome to the BioCHRIST fourth quarter 2025 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 . After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. 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 Bielder with Biochrist. Please go ahead.

speaker
Nick Bielder
Investor Relations

Good morning and welcome to Biochrist's full year 2025 corporate update and financial results conference call. Participating with me today are President and CEO Charlie Geyer, Chief Financial Officer Bob Ruggias, and Chief Development Officer Dr. Bill Sheridan. A press release and slide presentation about today's news are available on our investor relations website. Today's call may contain 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.

speaker
Charlie Geyer
President and CEO

This is my first earnings call as CEO of Viacryst, and I'm happy to report, happy about where the company is today, and even more excited about our future. We closed 2025 with strong momentum, delivering full-year Orlodeo revenue of $601.8 million. That was up 38% for the year and 43% when you exclude our Europe business that we sold in October. We are also starting 2026 on a high note as we expanded our HAE portfolio with our acquisition of Astrea Therapeutics last month. As I step into my new role, I want to be clear about BioCris strategy. We are and will remain a profitable rare disease company committed to meeting the unmet needs of patients through commercialization innovation and excellence that is backed by well-understood biology and disciplined clinical development. Where we will continue to evolve is how focused and explicit we are about capital allocation and accountability. We want to ensure that every dollar we deploy has a clear line of sight to driving long-term value creation. Coming back to our HAE portfolio, we see tremendous opportunity to build value by meeting the needs of a growing number of HAE patients. We view HAE not as a winner-take-all efficacy race, but as a structurally segmented market driven by biology, patient preference, and real-world experience. Rather than a market that resets with every new entrant, we see a market that segments based on the needs of individual patients. We now have a portfolio of differentiated products in Orlodeo capsules for ages 12 and up, Orlodeo pellets for younger kids, and a late stage asset in the Venobarb. Each of these therapies will allow us to achieve growth and durable revenue within specific segments of the market. Orlodeo has grown strongly in part because of its differentiation as the oral option. But more importantly, there is a super responder population that can get injectable-like attack control. We saw in our pivotal trial that just over 50% of patients starting on Orlodeo stayed on for two years and had a 91% reduction from baseline. In the real world, 60% of patients stay on therapy through 12 months, and nearly 50% of all patients who have tried Orlodeo in the U.S. over the past five years are still on therapy. Most Orlodeo super responders are unlikely to switch, even if another oral option reaches the market, because their needs are already met. And now we have a new member of the Orlodeo family. We are excited to launch Orladeo pellets for kids ages 2 to under 12 at the Quad AI Conference this weekend. The unmet need is significant because HAE and related attacks are underdiagnosed in younger kids, and prophy usage is only half that of adults. Availability of a safe, effective, and targeted oral prophy has the potential to change how kids with HAE grow up. and Orlodeo is likely to be the only oral option for several years to come. We think about Nivenibart through that same lens of structural differentiation in HAE. Nivenibart is not intended to replace Orlodeo. It is intended to allow Biochrist to address patients' needs across the full spectrum of efficacy, dosing, and convenience preferences in HAE prophylaxis. There are approximately 5,000 U.S. patients who have great attack control by injecting anywhere from twice a week to every four weeks. Most of them are reluctant to take a chance on oral because they are well-controlled already, and the injections themselves are not a barrier to treatment. Oral is not their need. But our research shows that many are very attracted to the idea of a simple, high-efficacy injectable, dosed just two or four times per year. That is a leap patients dosing an injectable 12, 26, or even over 100 times per year are likely to make because it aligns with what they know and provides something better. Our objective is to keep the HAE prophylaxis treatment decisions within the BioCrisp portfolio. That is another way we think about long-term durability, not as defending a single product, but as owning the prophy decision framework in HAE. we will offer three compelling options, all from a team that the HA community knows and trusts. Before turning to Bill, I want to briefly touch on BCX17725, our early stage program in Netherton Syndrome. This is a classic rare disease story, a devastating genetic condition that is underdiagnosed because there are no good treatment options. We are encouraged by the results and healthy volunteers and the investigator enthusiasm for this program. We're on a path to generate clinical data in patients by the end of the year, and we'll use that evidence plus feedback from patients and investigators to guide next steps. Looking ahead to 2026 and beyond, we see durable revenue growth anchored by a skilled, motivated, and resilient commercialization team meeting the needs of adults and kids who want oral HA prophylaxis. a second molecule advancing well in late-stage development that has the potential to lead the injectable prophylaxis segment, and additional rare disease optionality in our pipeline, positioning Viacryst for sustained value creation. With that, I'll turn it over to Bill to provide more color on our pipeline.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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