speaker
Sammy
Conference Call Coordinator

and thank you for joining the Zarius RFRMA second quarter 2025 earnings conference call. My name is Sammy, and I'll be coordinating your call today. During the presentation, you can register a question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two on your telephone keypad to remove yourself from the question queue. I'll now hand over to your host, Allison Way, Senior Vice President of Investor Relations and Corporate Communications to begin. Please go ahead, Allison.

speaker
Allison Way
Senior Vice President, Investor Relations and Corporate Communications

Thank you, Sammy. Good morning, everyone, and thank you for joining our call today. I'm joined with John Shannon, our CEO, and Steve Piper, our CFO. Earlier this morning, we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we will open the lines for questions. Before we would begin, I'd like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, projects, and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements. For more information on a risk, please refer to our earnings release and the risk factors included in our FTC filing. Any forward-looking statements in this call represent our views only as the date of this call, and subject to applicable law, we disclaim any obligation to update such statements. Please note some metrics we will discuss today represented in a non-GAAP basis. We've reconciled the comparable GAAP and non-GAAP figures in our press release. Please let me pass the call over to John for his opening remarks.

speaker
John Shannon
CEO

Thanks, Allison, and good morning, everyone. I'm excited to report that the strong momentum we established in the first quarter continued into the second quarter, driving another period of incredible performance and positioning us to outperform our original expectations for 2025. Our total revenue grew 49% to a quarterly record of almost 72 million. This success is being fueled by the strength of our commercial product portfolio, which grew 46% to approximately 68 million in Q2. Our exceptional performance was driven by an increased patient demand across all three products. RecoraLift continues to lead our growth with very strong demand driven by its differentiation as a much needed treatment for patients with hypercortisillemia and endogenous Cushing syndrome. GVOC once again delivered consistent, steady growth, supported by our efforts to increase awareness and reinforce adherence to medical guidelines. And at the same time, Cavaeus remains strong as we continue to add new patients, which led to an increase in the average number of patients on therapy in Q2. Building on this strong foundation and the exceptional results from both Q1 and Q2, we are raising our full year revenue guidance to reflect the very positive trajectory we see ahead. Our revised outlook anticipates total revenue in the range of 280 to 290 million, surpassing the high end of our previous guidance and representing year over year growth of 40% at the midpoint. This significant upward revision reflects our confidence in the growing demand for our commercial products and our operational discipline as we execute against our strategic priorities. Now let's turn to a more detailed review of performance by product beginning with RecoraLift. In the second quarter, RecoraLift grew an impressive 136% year over year, reaching over 31 million of revenue in the quarter. The average number of patients on therapy grew by more than 122% year over year, reinforcing our confidence that RecoraLift is solidifying its position as an important treatment option for patients with Cushing's syndrome. As we outlined during our June Analyst Day, RecoraLift is the right product at the right time. It's uniquely positioned to capitalize on the fast growing hypercortisolemia and Cushing's syndrome market. We are making deliberate and strategic investments to drive sustained growth for RecoraLift over the near and long term. These efforts are focused on a deepening engagement with healthcare professionals to accelerate patient identification while simultaneously strengthening our support model for patients as they navigate their therapeutic journey. Turning to GVOC. GVOC posted another great quarter with revenue of 23 million, a 17% increase compared to the second quarter of last year. Prescription volume continued its steady upward trend driven by both growth in prescribers and increased adoption among existing ones. We expect GVOC to remain a strong and dependable driver of our overall performance throughout the remainder of the year. Given the extensive number of people with diabetes that don't yet carry ready to use Gugagon, GVOC is well positioned for steady long term growth for many years to come. Now let's turn to Caveus. Caveus continues to demonstrate its importance in the treatment of patients with primary periodic paralysis. With revenue of more than 11 million in the second quarter, we saw a modest increase in the average number of patients on therapy, along with growth in new patient starts, underscoring the strength of the Caveus brand and our team's focus on execution. In fact, today is the 10 year anniversary of Caveus' FDA approval. And Caveus remains an important part of our portfolio, consistently serving patients with PPP and reinforcing our commitment to addressing the needs of this ultra rare community with a dependable and proven therapy. In addition to strong commercial execution, as I mentioned earlier, the second quarter was also defined by an important strategic milestone, our first ever Analyst and Investor Day. This event was a pivotal moment for us as we outlined our long term vision and key growth drivers, most notably Recorolive and our lead pipeline asset XP8121. The engagement we received from the investment community underscores the excitement we feel about the opportunities ahead. As many of you heard on Investor Day, we believe that XP8121, our novel once weekly subcutaneous therapy in development for the treatment of hypothyroidism is a very special product in the making. Of all the patients with primary hypothyroidism in the US, we estimate that three to five million of them are ideal candidates for this therapy because of their inability to achieve control with daily oral levothyroxine due to gastrointestinal absorption issues. We believe XP8121 represents a transformative opportunity in a space that has seen little to no meaningful innovation for decades, despite there being a significant unmet medical need. This is not for lack of trying, but because of the technical challenges are substantial. We've invested the time and resources to solve for those challenges, leveraging our proprietary zero-sol technology to develop a novel formulation and a high-precision delivery system capable of reliably administering a wide array of doses. Our clinical program will also generate a wealth of meaningful data, including regular thyroid hormone monitoring and quality of life assessments, which we believe can improve patient care, enhance our regulatory submission, and potentially support differentiated claims. Before I turn the call to Steve, I want to reiterate that our strong performance in the first half of the year further reinforces our confidence in the strength of our business and growth opportunities ahead of us. The increase in our 2025 revenue guidance reflects the momentum we've built by remaining focused on our strategic priorities, executing with discipline, and delivering value for patients, providers, and shareholders. With that, I will now turn the call over to Steve, who will provide a comprehensive review of our financial performance for the quarter and provide detail around our updated guidance and outlook.

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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