Guardant Health, Inc.

would like to ask a question, please press star 1 on your telephone keypad. I would now like to pass the conference over to your host, Zarek Khurshid, VP of Investor Relations. You may proceed.

Zarek Khurshid, VP of Investor Relations Thank you. Earlier today, Garden Health released financial results for the quarter and year ended December 31, 2024. Joining me today from GARDEN are Hal Neal Tukey, 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 be making 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-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures, are available in the press release GARDEN issued today, as well as in our 10-K and other filings with the SEC. GARDEN 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'd like to turn the call over to Halmy.

Thanks, Eric. Good afternoon, and thank you for joining our fourth quarter and full year 2024 earnings call. Starting on slide three, 2024 was an outstanding year for Garden. I'm so proud of our team for their hard work and execution on delivering on a number of key milestones across our portfolio. In oncology, we made significant strides in both therapy selection and MRD. We completed a major upgrade of our flagship Garden 360 test onto our new smart liquid biopsy platform, all while generating record revenue, increasing test volumes, and expanding the profitability of our therapy selection business. And we continued growing reveal volumes and generating evidence for our MRV business, positioning us well for an inflection this year. In screening, we received FDA approval and Medicare coverage for SHIELD, our screening blood test for CRC, opening up an enormous market for early detection of cancer. Our team fired on all cylinders in 2024, and I'm even more excited for what to come in 2025 in terms of product innovation, accelerated volume growth, and most importantly, the impact we will have on cancer patients around the world. As we typically do, I would like to start our call today with a story that highlights the importance of our tests and how they can work together synergistically to improve patient outcomes. In 2021, a 57-year-old woman was diagnosed with triple negative breast cancer. After completing standard of care therapy, she was tested for germline predisposition and was negative. Her oncologist then used imaging to monitor for recurrence. Unfortunately, after some time, imaging identified lung nodules. To get more information on whether or not these nodules were indeed metastatic, her oncologist ordered a noninvasive garden reveal test. The test came back positive for ctDNA and was automatically reflexed to a garden 360 test. Garden 360 identified a pathogenic BRCA1 mutation. The nodules were also confirmed to be metastatic triple negative breast cancer, and the patient is being considered for a PARP inhibitor. Gardner-Beal was crucial in confirming her cancer recurrence, and the ability to effortlessly reflex to Garden 360 helped her oncologist move quickly to determine the next steps in her treatment. Turning to top line performance in slide four, We had an excellent finish to the year with Sp4 revenue growing 30% year over year to $202 million, bringing our total full year revenue to $739 million, an increase of 31% year over year. Turning to slide five, this performance was driven by incredibly strong clinical revenue, which grew 34% year over year, supported by ASP and reimbursement tailwinds. Total oncology clinical volumes in the fourth quarter increased 24% year over year, bringing our total clinical volume growth to 20% for the full year 2024. This was largely driven by garden 360, which saw double digit volume growth in 2024. Turning now to slide 6 to take a closer look at the reimbursement tailwind supporting therapy selection. We saw significant ASP improvement over the course of the year. At our investor day in September of 2023, we stated our goal was to reach an ASP of $3,000 for Garden360 by 2028. We achieved this goal roughly four years ahead of target due to a number of reimbursement wins, including the increase of our Garden360 LVT Medicare rate from $3,500 to $5,000. We also saw significant improvements in both the amounts we have been paid for our tests and the speed at which we have been paid by commercial payers. In addition to Winsborough Garden 360, tissue Medicare pricing increased from $3,100 to $3,500 effective January 1st of this year, creating another important tailwind for our therapy selection business. Looking ahead this year, there are additional opportunities from state biomarker laws and continued commercial coverage expansion to further improve the ASB for our therapy selection products. Moving on to slide seven. Last July, we transitioned our Garden360 LDT onto our smart liquid biopsy platform, representing the most significant upgrade to our flagship precision oncology product. The upgraded test, called Garden360 Liquid, reinforces Garden360's leading position in liquid CGP. Garden360 Liquid expands a number of genes by nearly tenfold, including all guideline-recommended genomic markers for solid tumors, and improves the sensitivity for tumor burden detection by a factor of 10. Garden360 Liquid is resonating incredibly well and is helping to drive greater depth of ordering and increased testing frequency as physicians experience the capabilities of the upgraded platform firsthand. Importantly, we have a rich pipeline of additional features leveraging our smart platform, which we believe will generate a limitless number of differentiated applications. These apps will allow Garden360 Liquid to help identify more patients for existing therapies that are undetectable by current CGP tests detect harmful adverse effects of chemotherapy, and provide detailed phenotypic information about the tumor, such as histology, subtype, and much, much more. Given the positive traction we are seeing from GARDEN360 Liquid, we expect to continue to see an acceleration in GARDEN360 volume growth in 2025. Turning to slide eight, with our major product upgrades, growing use cases in both early and late stage settings, and opportunities for international expansion, I'm more confident than ever that the therapy selection portion of our oncology business will continue to see very strong growth over the next few years. Now shifting gears to reveal implied nine where we are the leader in tissue free MRD. We were thrilled that gardens reveal which runs in our smart liquid biopsy platform recently received Medicare coverage for CRC surveillance testing after curative intent treatment for stages one through four. Medicare reimbursement for Reveal is $1,644 per test, consistent with prior expectations. Utilizing CT DNA testing in the surveillance setting alongside standard of care monitoring, such as CT scans and CEA testing, has the potential to identify molecular recurrence of CRC ahead of traditional imaging. Now, Reveal will be more widely available to patients and support oncologists in making more informed therapeutic decisions. we are encouraged to see the recent NCCN guideline updates related to MRD. The changes are beginning to reflect what we are seeing in clinical practice and represent an increasing recognition of the value of ctDNA testing and returns monitoring. The NCCN guideline updates only further reinforce our view of the effectiveness of the opportunity as well as of our commercial strategy. Turning to slide 10, beyond CRC surveillance, we have an extensive pipeline of clinical courts, to further support validity and utility for garden reveal. We recently submitted data for publication supporting potential Medicare reimbursement for coverage in breast cancer and therapy monitoring. Looking ahead, we have a number of ongoing clinical validity studies for additional cancers, and we look forward to sharing updates on their progress throughout the year. Moving on to slide 11. During the course of 2024, we made critical progress to reduce the COGS for reveal and achieve more than a 50% reduction exiting the year. This reduction will save tens of millions of dollars in 2025 and was largely supported by the transition to a smart liquid biopsy platform. This is an incredible accomplishment and is a testament to our team's ability to execute well. Turning to slide 12, Reveal was on track to reach an important inflection point in 2025. As a reminder, despite very strong demand, we had been managing Reveal volumes ahead of Medicare reimbursement in order to manage our cash burn. Now with CRC surveillance reimbursement in place, improving ASP, and achieving a meaningful reduction to our COGS, making the test gross margin positive, we'll be leveraging a robust commercial channel in oncology to push ahead with a reveal to meet the market demand for a tissue-free MRD test. This long-awaited milestone unlocks a key commercial market for us this year, and our team is focused in executing at a high level. Turning to slide 13. We had a very strong year for biopharma, with 2024 revenue growing 31% year over year. This was fueled by our growing number of biopharma partnerships, now above 180, and the growing mix of our smart liquid biopsy platform, which now represents more than 50% of reported samples in new contracts. Our smart liquid biopsy products offer improved performance, as well as key applications, such as novel biomarker discovery and signature development. This offering was a major growth catalyst in 2024 and is supporting strategic partnerships with top 20 global biopharma companies. looking more closely at some of the recent highlights within our biopharma and data business on slide 14. We recently announced a collaboration with Boehringer Ingeheim to develop a companion diagnostic for the detection of specific mutations in advanced lung cancer, and we have a robust pipeline of other companion diagnostic partnerships positioning us well for this year. Moving on to data, in early January, we announced a collaboration with Concert AI to create a differentiated data as a service platform that integrates comprehensive patient EMR records with both genomic and epigenomic tumor profiling data. This platform augments garden and form with insights from Concert AI's national database of 5.5 million clinical records and our profiling data across more than 60 tumor types. This combined real-world evidence platform will help to accelerate cancer therapy research and development for biopharma partners. Our mission is to conquer cancer with data, and this collaboration brings us one step closer to achieving this goal. With that, I will now turn the call over to Amir Ali for an update on screening.