2/23/2026

speaker
Operator
Conference Operator

Good day, and thank you for standing by. Welcome to the Myriad Genetics fourth quarter and full year 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Matt Scalo, Senior Vice President of Investor Relations. Please go ahead.

speaker
Matt Scalo
Senior Vice President, Investor Relations

Good afternoon, and welcome to Myriad Genetics' fourth quarter and full year 2025 earnings call. During the call, we will review the financial results we released today, and afterwards, we will host a Q&A session. Our earnings release was issued this afternoon on Form 8K and can be found on our website at investor.myriad.com. I'm Matt Scalo, Senior Vice President of Investor Relations. On the call with me today are Sam Raha, our President and Chief Executive Officer, Ben Wheeler, our Chief Financial Officer, and Mark Verratti, our Chief Operating Officer. Also joining us for Q&A will be Brian Donnelly, our Chief Commercial Officer. This call can be heard live via webcast at investor.myriad.com, and a recording will be archived in the investor section of our website along with this slide presentation. Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the SEC, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements. I will now turn the call over to Sam.

speaker
Sam Raha
President and Chief Executive Officer

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. As we head into the new year, I'm pleased with the progress we're making as the new Myriad to live up to our significant potential by focusing on high growth market segments, advancing our plans for multiple timely product launches, including leveraging strategic partnerships, and by executing with stepped up urgency and strengthened execution rigor. I'm happy with how we ended 2025 with fourth quarter revenue of $210 million, coming in above the high end of the pre-announced range we provided in January. When you exclude the headwind from UnitedHealthcare's decision on GeneSight, our business grew approximately 4% over Q4 of 2024. In terms of testing volume, we delivered 382,000 test results in the fourth quarter. Our financial results were supported by continued strong volume growth for MyRisk in oncology at 14% over the year-ago quarter and MyRisk for unaffected at 11% over the year-ago quarter. These results reflect our ongoing efforts to enhance the customer workflow, including EMR functionality. Mark will provide additional color in his section, but certainly we continue to see positive demand for our MI-RISC regulatory cancer test, and this supports our accelerated profitable growth journey ahead. I'm also pleased to call out the acceleration in Prolaris test volume growth in the fourth quarter, where the combination of actions over the last two quarters, including incremental investments in the commercial team focused on urologists, have helped drive 12% test volume growth year over year. Fourth quarter prenatal volume declined year over year, primarily stemming from Q2 order management disruption. With this issue resolved, we're now in an active rebuild phase, reactivating accounts, expanding access, and driving new customer wins. We expect these actions to support a return to positive growth in 2026. Moving to our mental health business, GeneSight volume grew 9% year-over-year and continued to accelerate from the first half of 2025 as our commercial organization maintained strong execution with new and existing customers. For the full year of 2025, revenue was $824.5 million and we delivered over 1.5 million test reports by serving over 55,000 healthcare providers. Turning now to profitability. In the fourth quarter, we reported strong adjusted gross margin of 70% and closely managed our discretionary spend as reflected in our adjusted OpEx line. Ultimately, we reported healthy adjusted EBITDA of $14.3 million and adjusted EPS of 4 cents. We're also making great progress on our cancer care continuum strategy to maintain leadership, regulatory cancer testing, while expanding into other attractive cancer testing applications. This includes launching the expanded MIRIS panel in Q4, which has been well received in the market. We're also sharing results from an increasing number of studies and precise MRD with positive clinical data presented in major clinical conferences. and we're in final preparation mode to start commercial testing of Precise MRD for breast cancer for a select set of customers in what we call an alpha launch starting next week. Overall, we're making good progress towards our goal of expanding our portfolio of differentiated testing solutions that provide actionable insights across the cancer care continuum. From a new product pipeline perspective, 2026 is shaping up to be a banner year. Throughout the year, there are a number of important catalysts that we will be tracking that supports this year's growth. But even more, these are leading indicators of key growth drivers for 2027 and beyond. We're making significant progress on a number of catalysts outlined in this slide. Our strong fourth quarter test volume growth for MI-RISC reflects ongoing traction of our breast cancer risk assessment programs and the launch of our expanded MI-RISC test. We plan to launch disease-specific panels for MyRisks in Q2 and expect our market activation programs and product extensions to support increased MyRisks growth. Building on Prolaris' strong fourth quarter performance, we're on track to launch our first AI-enhanced Prolaris prostate cancer test in Q2 that combines the power of molecular and AI analysis. And this is based on our partnership with Pathomic. On Precise MRD, as I noted earlier, we're on track to commence commercial testing for a select set of customers next week, and I'll provide additional color on the next slide. At JPMorgan Healthcare Conference in January, we reconfirmed that our first Precise MRD test will be for breast cancer and announced additional indications that will follow. We plan to submit for Moldex and expand commercial testing for early access customers for both renal and colorectal cancer in the second half of the year, with commercial launch of breast, renal, and colorectal plan for 2027. All of these precise MRD tests have a growing body of clinical validation, some of which has been shared recently in venues, including presentations at the San Antonio Breast Cancer Symposium in December, ASCO GI Symposium in January. where a first look at precise MRD data related to colorectal cancer was presented by collaborators from National Cancer Center Hospital East in Japan, showing how the ultra-sensitive detection of precise MRD can have additional benefits compared to first-gen MRD tests. and to round out the robust 2026 pipeline. We're on track to launch first gene multiple prenatal screen tests in the second half of this year. The timing of this launch dovetails nicely the deployment of a focused prenatal health sales team next quarter and the expected early results of the connector study in the next few months. As we prepare to achieve the important milestone of commencing commercial testing for select set of customers with precise MRD for breast cancer patients next week, I want to help frame expectations at this stage. This slide highlights our three objectives. First, we're looking to further showcase Precise MRD's clinical performance while continuing to build a body of real-world evidence. Data shows Precise MRD's high sensitivity and ability to detect disease down to one part per million. We believe our MRD platform can help guide clinical decision making for patients in their journey in cancer care and has the ability to detect presence and recurrence meaningfully earlier than the standard of care with imaging and therefore can positively impact patient outcomes. Second, nearly 85% of cancer care in the US happens in the community. That's where Myriad has a strong, established presence where we served nearly 3,500 oncologists in 2025. We've seen strong interest from our community oncologist base to participate in the alpha and early access stages of our commercial rollout. Clearly, this is an encouraging sign, but we also remain disciplined regarding the overall number of participating centers in these early stages of launch to ensure good customer experience and manage our profitability. We will look to expand the number of centers as we move through 2026. And the third objective is to track and learn from specific metrics appropriate for this early stage. After all, you get what you measure, and we'll look to provide an appropriate level of visibility into these metrics moving forward, starting with the Q1 earnings call. While we're excited and busy preparing for multiple launches this year, I want to reiterate that there is little to no contribution from these MRD tests in our 2026 revenue guidance. Going into 2026, we're taking a number of actions to accelerate growth. This includes our plan to invest over $35 million over the next few years to support a number of initiatives to accelerate organizational efficiency, agility, and growth. These initiatives include strengthening our commercial capabilities, particularly in the cancer care continuum. Specifically, we're adding a meaningful number of sales and medical headcount ahead of multiple new product launches this year. Many of these new additions come from advanced diagnostics sector and bring strong domain knowledge and experience in molecular profiling and cancer diagnostics along with relationships across the oncology healthcare community. In addition, we're strengthening the tools critical to our sales team. while implementing a comprehensive plan to drive awareness, excitement, and demand for our products. I attended our commercial kickoff meeting last month, hosted by Brian Donlier, Chief Commercial Officer, and I can say our teams are energized and highly motivated to win in the market. Now, let me hand it over to our COO, Mark Verratti. Mark.

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