Guardant Health, Inc.

Good afternoon. Thank you for attending the Gardened Health 2023-2025 earnings call. My name is Cameron and I'll be your moderator for today. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star followed by one on your telephone keypad. And during the Q&A session, we ask that you please limit yourselves to one question. Again, during the Q&A session, we ask that you please limit yourselves to one question. And I would now like to pass the conference over to your host, Zahra Khurshid with Garden Health. You may proceed.

Thank you. Earlier today, Garden Health released financial results for the quarter ended September 30th 2025. Joining me today from GARDEN are Helmi Eltuki, Co-CEO, Amir Ali Talasaz, Co-CEO, and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated this call will also include a discussion of non-gap financial measures which are adjusted to exclude certain specified items additional information regarding material risks and uncertainties as well as the non-gap financial reconciliation the most directly comparable gap financial measures are available in the press release garden issued today as well as in our 10k and other filings with the sec GARDS disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmi.

Thanks, Derek. Good afternoon, and thank you for joining our third quarter 2025 earnings call. Starting on slide three. Q3 was an exceptional quarter for Garden with broad-based growth across our business. Sympology volumes grew 40% as year-over-year volume growth continued to accelerate, driven by Garden 360 Liquid, Garden 360 Tissue, and Reveal. Our biopharma business grew nicely year-over-year with positive CDX momentum and screening volume accelerated with a sequential increase of 8,000 shield tests. Importantly, screening has started to generate meaningful revenue, tracking at an annual run rate of approximately $100 million roughly one year into the commercial launch of the FDA-approved product. Overall, we are very pleased with our performance this quarter, delivering 39% year-over-year revenue growth and crossing over $1 billion in annualized revenue for the first time. Excluding screening, we reached a major milestone with the rest of the business becoming cash flow positive one quarter earlier than expected. Indeed, this quarter sets us up very well to deliver on the long-term plan that we laid out at our investor day last month. Lastly, we recently surpassed 1 million cumulative clinical patients tested by Gardent, and as such, we want to highlight one of these patients with a story that captures the profound impact our tests are having in everyday clinical practice. A 67-year-old man had gone on screen for colorectal cancer for several years. Despite his physician-operating colonoscopy or stool-based tests, annually beginning in 2021. Each time, the patient declined to be screened. In December 2024, the physician ordered a shield blood test, and the patient agreed to complete the blood draw during the same visit. The result came back positive. When his physician explained that a positive shield result required a follow-up colonoscopy, the patient agreed to have the procedure despite previously resisting. The colonoscopy was performed in January of 2025, revealing colorectal cancer. The patient quickly began treatment, and at his most recent follow-up, he had successfully completed therapy and was doing well. This is a powerful example of how the SHIELD blood test can remove barriers to screening, provide a more pleasant and convenient option for patients, and ultimately improve outcomes. Now turning to top line performance in slide four. Q3 revenue grew 39% year over year to $265 million with strong performance again across our oncology screening and biopharma and data businesses. Taking a closer look at our oncology business on slide five. Oncology revenue increased 31% to $184 million and oncology volumes increased 40% year over year to approximately 74,000 tests in the third quarter. Turning to slide six, we have seen a clear acceleration in volume since July of last year, following the introduction of Garden360 Liquid on our smart platform. Since then, we have launched two additional waves of applications, driving five consecutive quarters of accelerating volume growth, and we look forward to future waves of smart app introductions developed through the power of Infinity AI to help fuel future growth. In addition to Garden360 Liquid, Garden360 tissue and reveal volumes also experience strong year-over-year growth. Moving on to slide seven. As a reminder, our Infinity AI Learning Engine applies AI across our data treasury of over 1 million patient samples, including more than 350,000 epigenetic profiles across more than 100 tumor types to bring powerful insights and new products to market faster than ever. Infinity AI enables higher resolution mapping of tumor biology giving rise to not only entirely new products in the clinical business, but novel signatures for faster drug discovery relevant to our biopharma business and new commercial insights and decision support tools. Turning to slide eight. To date, we've launched 15 groundbreaking smart apps on GARDEN360 LIQUID with dozens more in development that will roll out across GARDEN360 LIQUID, TISSUE, and REVEAL. Each new application builds towards what we see as a GPS for cancer care, guiding physicians with the right insights at every step of the patient journey. We believe these applications not only significantly expand the clinical utility of GARDEN360 Liquid, but further extend our technical leadership in the liquid CGP market. Looking more closely at some of the recent highlights within our oncology business in slide nine, Garden360 volume grew exceptionally, with more than 30% year-over-year growth. Garden360 tissue also had a great quarter, showing strong year-over-year acceleration following the major product upgrade released in the second quarter. Once again, Reveal contributed very nicely and continues to be our fastest-growing oncology product. In addition to the strong performance, we recently reached a major milestone with submission of our PMA application to the FDA for GARDEN360 Liquid. This submission has potential to streamline GARDEN360 Liquid with a single flagship FDA approved liquid biopsy for therapy selection, simplifying our portfolio, accelerating adoption, and further strengthening our leadership in this space. In addition, FDA approval would lay the foundation for ADLP designation which is an important mechanism for capturing the appropriate value for our expanded test offering in the future. We had a strong presence at ESMO 2025 with 15 abstracts spanning the cancer care continuum from MRD detection and recurrence monitoring with studies such as Pegasus to advanced stage tumor profiling and therapy response assessment. For reveal, we're making great progress with data generation and publications. We recently submitted our immuno-oncology therapy monitoring data package to Moldvx to support Medicare reimbursement and submitted data from our chemotherapy monitoring study for publication. Turning to slide 10 to take a closer look at our reveal data pipeline. Over the last few months, we've made significant progress in MRD, generating and publishing compelling data across multiple cancer types. Earlier this year, we achieved Medicare coverage for CRC surveillance and have since submitted dossiers for breast surveillance and, as I just mentioned, for immuno-oncology therapy monitoring. We plan to submit packages for chemotherapy and CDK4-6 inhibitor monitoring following those publications. Looking ahead, we have ongoing studies across more than five additional tumor types in both the adjuvant and surveillance settings. Together, this growing body of evidence will continue to strengthen the clinical utility and analytical validity of Reveal, supporting broader adoption in MRD. Turning now to slide 11. I'm proud of the progress we have made over the last few years in both driving demand and revenue growth across our portfolio. Looking ahead, we see multiple drivers across our oncology business that position us well for durable long-term growth. We will continue investing in commercial initiatives that make it easier for physicians to access our tests through portal enhancements, EMR integrations, and enhanced workflows. In our therapy selection business, Transitioning to the smart platform unlocks wave after wave of novel applications, many unique to Gartland, that will help us differentiate and continue gaining market share. And in MRD, a redoubled commercial focus and reveal, supported by significantly lower COGS and Medicare coverage for CRC surveillance, positions us for strong growth ahead. We're also excited to introduce an ultra-sensitive tissue-informed MRD assay, that will complement our best in class tissue free reveal test. Looking more closely at some of the recent highlights within our biopharma and data business in slide 12, we delivered another strong quarter with third quarter revenue growing 18% year over year. We continue to deepen our relationships with large pharma and had two additional companion diagnostic approvals in Q3. In late September, GARDEN360-CDX received FDA approval as a companion diagnostic to Enlurio for the treatment of ESR1-mutated advanced breast cancer. This marks the second FDA-approved indication in breast cancer and the sixth overall CDX claim approved by the FDA for GARDEN360-CDX. We also received regulatory approval in Japan for GARDEN360-CDX as a companion diagnostic to Enher2 for non-small cell lung cancer patients with HER2 mutations. We now have 23 total CDX approvals across biomarker and tumor types. Our robust and growing pipeline of partnerships ensures that near-term revenue visibility remains high. With that, I will now turn the call over to Amir Ali for an update on screening.