Guardant Health, Inc.

Thank you. Earlier today, Garden Health released financial results for the quarter ended September 30th, 2024. 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-GAAP financial measures which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties as well as the non-GAAP 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 would like to turn the call over to Helmi.

Thanks, Eric. Good afternoon, and thank you for joining our third quarter 2024 earnings call. Starting on slide three, 12 years ago, we embarked on our mission to conquer cancer with data. Roughly two years later, we launched into the late stage cancer market with our first version of garden 360 in 2014 in 2021 we launched garden reveal for cancer occurrence and monitoring. And this past quarter on August 1 we were thrilled to launch our first test into the asymptomatic cancer screening market with shield unlocking an exciting opportunity to potentially impact millions more individuals across the cancer continuum. As is our practice, I would like to start our call off with a story illustrating the important impact our tests can have on improving patients' lives. A woman was initially diagnosed with left breast cancer when she was 50 years old. With a family history of cancer, she opted for an aggressive treatment and underwent a double mastectomy. A few years later, she began experiencing hip and lower back pain. After a doctor determined the breast cancer had metastasized, A GARDEN360 liquid biopsy test was ordered to determine if the metastasis had any actionable biomarkers. An ESR1 mutation was revealed, and she was placed on elastistrand for therapy. The GARDEN360 test report also noted a BRCA2 variant, which was later confirmed to be a germline mutation after further testing in a specialized lab. As a result, her family underwent genetic testing and her sister was found to carry the same BRCA2 germline mutation but had not experienced a cancer diagnosis to date. Her sister chose a prophylactic double mastectomy and oophorectomy as treatment and was found to have occult ovarian cancer. This case highlights the remarkable ability of Garden360 to provide life-saving information both for patients with symptoms and for those without. Turning to top line performance in slide four, we continued our strong momentum into the third quarter with total revenue growing 34% to a record $191.5 million. This was driven by another quarter of robust precision oncology revenue, which increased 35% in the quarter supported by significant garden 360 reimbursement tailwinds and broad based volume growth fueled by our smart liquid biopsy transition. Turning to slide five, clinical test volume for the third quarter grew 21% year-over-year and 7% quarter-over-quarter, reaching 53,100 tests, driven by strength across the portfolio. In particular, Garden360 performed extremely well in Q3 and grew mid-single digits sequentially. Furthermore, Reveal continues to see strong growth even with our ongoing careful management of volumes ahead of broader reimbursement. As a reminder, our clinical test volume is specific to our oncology tests, which are GARDEN360, TissueNext, Response, and Reveal, and does not include screening test volumes from Shield. Q3 was another standout quarter for biopharma, with volumes up 40% year-over-year to our record 10,500 tests. I will share some more details in our biopharma progress shortly. Looking more closely at some of the recent highlights within our therapy selection business in slide six. In late July, we launched our upgraded GARDEN360 LVT and smart liquid biopsy, representing the most significant upgrade to our flagship precision oncology product. GARDEN360 is the leading liquid biopsy test for patients with advanced cancer with industry-leading turnaround time and the improved platform positions us for continued robust growth and share gain. The GARDEN360 upgrade expands the number of genes by nearly tenfold, includes all guideline-recommended genomic markers for solid tumors, improves the sensitivity for tumor burden detection by a factor of 10, and introduces the first feature enabled by our methylation tech stack and therapy selection. As the performance and richness of the GARDEN360 LDT product evolves, and we continue to generate clinical data and add features, oncologists will gain an unparalleled view of cancer that we believe will quickly become a new standard of care in the clinical management of advanced cancer patients. Due to this compelling upgrade, we are very pleased that we are already seeing an increase in both breadth and depth of accounts and believe this will continue to drive growth as additional capabilities are unlocked over time. In particular, Garden360 LVT on smart liquid biopsy was the strongest contributor to year-over-year and sequential volume growth in the third quarter. We also saw continuing improvements in Garden360 ASPs, which reached $3,000 in the third quarter. Last quarter, we shared the upgrade of our TissueNext test to identify more treatment options for patients with advanced cancer. We have seen strong interest in the expanded panel and are excited to share that effective January 1st, 2025, Medicare pricing will increase from $3,100 to $3,500. Following these great updates, I'm excited to share that we again generated positive free cash flow in our therapy selection business in the third quarter. We also announced a partnership with Polyclinico Gemelli in Rome, a leading European oncology center, to implement onsite processing of GARDEN360 CDX tests for therapy selection in advanced cancer patients. This will mark one of the first dedicated liquid biopsy testing facilities housed within a hospital system in Italy. This partnership is significant given there are approximately 400,000 new malignant tumor cases recorded annually across Italy. When implemented, oncologists in Italy will be able to access our tests to make more informed treatment decisions for patients with solid tumor cancers. Finally, results from the Scrum Japan Godzilla study were recently published in Nature Medicine, demonstrating the significant survival benefits of using Garden360 CDX to test patients with advanced gastrointestinal cancer. Of the 4,037 patients in the study, 24% received personalized targeted treatment based on Garden360 CDX, And this subgroup survived nearly twice as long as those who did not receive GARDEN360 match therapy. This study further solidifies the clinical utility of GARDEN360 in guiding effective treatment decisions for advanced cancer patients. Turning to our biopharma business in slide seven. As I mentioned earlier, we had another record quarter of reported biopharma samples growing 40% year over year. Biopharma revenue grew 34% year over year in the third quarter. We continue to see a lot of excitement for Garden Infinity, our newest biopharma offering, powered by our smart liquid biopsy platform, driven by applications such as improved performance, novel biomarker discovery, and signature development. Smart liquid biopsy now represents over 50% of reported samples and new contracts. Importantly, this strength in biopharma is driven by our smart liquid biopsy upgrade, and we are still in the early endings of this exciting upgrade cycle. We have recently seen an acceleration of our clinical GARDEN360 LDT volume, demonstrating how biopharma R&D testing is an important leading indicator for demand of our clinical oncology tests And in turn, clinical patient testing is a driver for increasing biopharma interest. Taking together these elements create an important virtuous cycle in the precision oncology space. Finally, we are also seeing increased momentum in China with a strong and growing pipeline of samples. Now shifting gears to Reveal on slide eight, where we are the leader in tissue-free MRD. Last quarter, we shared that data from our COSMOS colon study looking at stage two and stage three patients was published in the peer-reviewed journal Clinical Cancer Research. This study was also submitted to MoldeX for Medicare reimbursement for the CRC surveillance MRD indication, and review is ongoing. Beyond CRC surveillance, we have an extensive pipeline of clinical cohorts for establishing validity and utility for garden reveal. This will be instrumental in building compelling evidence that not only supports efforts to expand reimbursement, but also has potential to influence changes in practice guidelines. Looking ahead to the remainder of the year, we anticipate submissions for publications that will support potential Medicare reimbursement for coverage in breast cancer. Next year, we have important clinical validity studies for additional cancers such as lung, pancreatic, and gastric. Moving on to slide nine. We are excited by the demand we are seeing in the tissue-free MRD market, and there are multiple near-term inflection opportunities in 2025. We continue to make good progress towards CRC surveillance reimbursement, which will improve our ASP. We also remain on track on our COGS reduction initiatives for reveal. As a reminder, these two milestones will be a significant step towards our long-term goal of achieving greater than 60% gross margins for our MRD business. While we are seeing strong growth and strong market appetite for Reveal, we continue to manage volumes to minimize cash burn and will continue to do so until Reveal is gross margin positive, which we anticipate in 2025. Overall, we are seeing tremendous growth and opportunity around Garden360, TissueNext, and Reveal, largely driven by our recent smart liquid biopsy platform transition. As a result of the great progress we have made this year, and are continuing to make, we are more confident than ever that our oncology business will continue to see strong growth over the next few years. With that, I will now turn the call over to Amir Ali for an update on screening.

Thanks, Helmi. Moving on to slide 10. As we have previously announced, we are thrilled that FDA has approved our SHIELD blood test for colorectal cancer screening in adults ages 45 and older who are at average risk for the disease. SHIELD is the first blood test to be approved by FDA as a primary screening option for CRC, as also the first blood test for CRC screening that is now covered by Medicare. Turning to slide 11. Just a few days after FDA approval, we brought Shield IVD to market with a successful launch in August. Our initial strategy is to focus on the covered patient population. This approach will help us establish a strong foundation for industry-leading long-term scalability and profitability. I'm excited to share that we have had very positive reception and seen strong demand from physicians and patients in the first few months of the test being commercially available. To highlight this positive impact of SHIELD, I'd like to share an example of a primary care provider in rural South Carolina who had previously been facing challenges keeping patients up to date with colorectal screening guidelines. With the introduction of SHIELD blood tests, he had seen his screening rates skyrocket. And in just the last few months alone, four of his patients received positive SHIELD tests, quickly went through colonoscopy procedures, and ultimately were diagnosed with early stage colorectal cancer. In all four of these cases, the disease was caught early enough that these patients only required partial coloectomy, avoiding any further treatment, and most importantly, were able to quickly resume their lives. Turning now to slide 12 to share some more exciting details on the launch reception. Early post-launch volume was ahead of our expectations, and we exited the quarter with strong momentum, which we continue to see in the fourth quarter. The majority of our volume is coming from covered patients. We saw robust depth of ordering by prescribing physicians. We continue to see an incredibly strong adherence rate of over 90%. which means over 90% of the patients completed the blood draw. And we are on track to have a trained sales force of over 100 people in the field by end of this year. Moving on to slide 13. We are very pleased to report that SHIELD received a Medicare price of $920, recognizing SHIELD as an important new class of first-line CRC screening. This Medicare price makes us more confident that our ASP will be approximately $500 even prior to an advanced diagnostics laboratory test or ADLT designation. We continue to expect to obtain ADLT designation and secure an even more favorable Medicare price of $1495 in 2025. Turning to slide 14. CMS has finalized the policy to remove cost sharing for a follow-on colonoscopy after a blood-based screening test for Medicare beneficiaries. This ruling proactively removes barriers to blood-based CRC screening and acknowledges its unique benefits to promote access to cancer prevention and early detection, particularly for individuals within rural communities and communities of color that are especially impacted by the incidence of CRC. We are encouraged by the quick inclusion of blood in the final 2025 physician fee schedule. This rule will go into effect on January 1, 2025. Moving on to slide 15, we are proud of our team's execution throughout 2024, starting with publishing our pivotal study results in the New England Journal of Medicine, followed by positive advisory panel voting, receiving FDA approval with the first line screening label, and finally securing a favorable reimbursement rate and successful commercial launch. We look forward to executing our commercial scale up and ramping adoption throughout the remainder of this year. We are excited about our upcoming milestones in 2025 and making Shield one of the most impactful products in the history of diagnostics. We are optimistic about the potential inclusion of SHIELD in American Cancer Society or ACS guidelines and expect to secure ADLT status, which enables improved ASV. We are pleased with the progress on indication expansion for SHIELD to become a leading multi-cancer detection blood test and expect to present our multi-cancer data. We are also planning to upgrade our CRC screening test with SHIELD v2. With that, I will now turn the call over to Mike for more detail on our financials.