Guardant Health, Inc.

Thank you.

Earlier today, Garden Health released financial results for the quarter and did March 31, 2021. If you have not received this news release, or if you'd like to be added to the company's distribution list, please send an email to investors at gardenhealth.com. Joining me today from Garden is Helmy Eltoukhy, Chief Executive Officer, Amir Ali Talasaz, President, and Mike Bell, Chief Financial Officer. Before I begin, I'd like to remind you that management will make statements during this call that are forward-looking statements. and 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. Additional information regarding these risks and uncertainties appears in the section entitled Forward Looking Statements in the Press Release Card and Issue today. For a more complete list and description, please see the Risk Factors section of the company's annual report on Form 10-K for the year ended December 31, 2020 and in its other filings with the Securities and Exchange Commission. This call will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings relief submitted to the SEC. Except as required by law, GARDEN disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast May 6, 2021. With that, I'd like to turn the call over to Helmy.

Helmy Eltoukhy Thanks, Carrie. Good afternoon and thank you for joining our first quarter 2021 earnings call. Everything we do at Garten is motivated by our commitment to serve patients. In line with our patient-first commitment, I will start off our call today with a patient story. Six years ago, a 64-year-old man was diagnosed with metastatic colorectal adenocarcinoma and went through numerous therapy regimens and surgeries. In the spring of 2020, his cancer recurred, and his new oncologist ordered a garden 360 test. A BRAF B600E mutation was identified. It is estimated that this mutation occurs in approximately 8% to 10% of colorectal cancers. By identifying this actionable mutation, He was able to begin treatment with a combination of targeted therapies of N-carotinib plus penetumumab, only recently approved by the FDA. Fortunately, the patient responded to this targeted therapy. But as we know, tumors are constantly evolving. After about six months, the patient was showing signs of progression. His oncologist ordered another GARDEN 350 test with our expanded panel that includes tumor mutational burden, or TMDs. This second GARDEN-360 test identified the patient's tumor as PMB-high. A few months earlier, the FDA had approved pembrolizumab for patients with PMB-high tumors of 10 new patients per megabase and above. So this finding opened up another therapeutic avenue for this patient. This story highlights how genomic profiling using GARDEN-360 can keep up with the evolution of a tumor and identify ongoing therapeutic options. Turning to our first quarter performance, we started the year strong with revenue growing 17% to approximately $79 million. I am really proud of our team for their continued hard work this quarter, which translated to solid growth in our clinical business, as well as progress across our product pipeline. As expected, we continue to see residual COVID impacts at the beginning of the year, but over the course of the quarter, as physician offices started to reopen, business improved further. Even with the persistent presence of COVID headwinds, clinical volume grew 21% to record levels of 18,390 tests. We continue to extend our position as a liquid biopsy leader for therapy selection, and there is still a vast amount of greenfield opportunity ahead in this market. The underlying fundamentals of our clinical business are very strong, and we continue to see growth in both new physician ads and receipt orders. Even with the residual impact from COVID that we anticipate this year, we expect our clinical volumes to grow more than 40% over 2020. We also made important progress on the reimbursement front. At the end of March, CMS confirmed that our GARDEN360 CDS test meets the criteria for Advanced Diagnostic Laboratory Test, or ADLP, status, which is reserved for FDA-approved tests as well as for innovative products that provide novel clinical information that cannot be obtained by any other method. With ADLP status, Garden360 CDX will be reimbursed at a rate of $5,000 for all Medicare patients in line with our internal expectations. Now moving on to our recurrence monitoring opportunity with GardenReveal. We are very pleased with the tremendous enthusiasm we are hearing from oncologists since its launch in mid-February. As a reminder, Reveal is the first blood-only liquid biopsy test for the detection of residual and recurrent disease. With a simple blood draw, the test improves disease management of early-stage colorectal cancer patients by detecting ctDNA in blood after surgery to identify patients with a residual disease who may benefit most from adjuvant therapy and by detecting recurrence months earlier than current standard of care. We believe Darden Reveal is truly in a class of its own. with industry-leading sensitivity and specificity and an average turnaround time of only seven days compared to other tests that require a tissue biopsy and have turnaround times of four to eight weeks. Much as we saw with the launch of GARDEN360, a blood-only solution addresses the significant logistical challenges posed by tissue in this setting. Today, the standard of care is CEA, a blood test where you get your results a few days later. Importantly, GardenReveal fits into an oncologist's workflow in the exact same way as CEA is used, but gives them extraordinarily better performance. CEA has a sensitivity of 59% with 64% specificity in the surveillance setting versus 91% sensitivity with 100% specificity for GardenReveal. So they are getting the better product market fit with the benefits of improved performance. It is still early, but we are seeing strong updates from both new users as well as customers that have been using other products on the market and benefiting from the deep relationships we have within the oncology community. From the onset, we have said that it takes more than just great technology to drive durable, long-term adoption of new products. This type of sustained growth requires seamless integration into clinical workflows, demonstrated clinical utility, Regulatory Approval, and Broad Reimbursement. As for our work with Garden 350, we are committed to achieving excellence in each of these to ensure that our product drives superior value to the market and maximizes access for patients. We are making great progress on the reimbursement front and are confident we will have Medicare reimbursement in place for Gardener Revealed by end of 2021. At the beginning of April, The New York State Department of Health Clinical Laboratory Evaluation Program, or CLEPS, approved garden reveal for the detection and monitoring of MRD in patients with early-stage cancer. This approval is an important proof point for reveal and builds on our commitment to improving care for all cancer patients by expanding access to our tests through compliance with the appropriate clinical laboratory regulations. I am so excited about what is ahead for gardens and believe Thank you for joining us. We have generated data across multiple tumor types, including lung, breast, gastric, and bladder cancers, and multiple classes of therapies, including immunotherapies, that demonstrate a second GARDEN-360 test a few weeks after treatment initiation can segment responders versus non-responders. To that end, a new study recently published in J.C. Oakes' Precision Oncology show that GARDEN360 provides an early indication of treatment response to pembrolizumab-based immunotherapy by detecting molecular response as measured by changes in circulating tumor DNA levels early on. This study adds to the growing body of evidence showing that our GARDEN360 tests can effectively measure molecular response, giving clinicians an earlier indication of whether to continue or stop treatment to explore other therapeutic regimens or to enroll the patients in the clinical trials. Monitoring molecular response is an important application of our technology platform that will soon usher in a new era of adaptive management of treatments and disease, all within the reach of any oncologist using a simple blood draw. We are also looking forward to the upcoming launch of our first tissue product, which we believe will address the unmet need that persists in the therapy selection market today. due to the challenges with many of the existing tissue offerings. In recurrence monitoring, we'll continue to drive the adoption of garden reveals, just as we did with Garden360 several years ago, ushering in a new era of precision oncology for earlier stage patients. And finally, in screening, we expect to complete enrollment of our Eclipse file before the end of the year and to begin work on our expansion into other cancer types. To support our ambitious vision, we are continuing to grow our incredible team. I am excited to welcome Dr. Craig Eagle, who recently joined Garten as our new Chief Medical Officer. Craig most recently served as Vice President of Medical Affairs Oncology for Genentech, where he oversaw the medical programs across the oncology portfolio. Craig has a wealth of experience driving medical affairs, clinical development, and clinical trial operations at leading pharmaceutical companies, and he will undoubtedly make a great impact as we continue to develop and commercialize best-in-class products and scale the company for the future. With that, I will now turn the call over to Amir Ali for more details on our biopharma business and our pipeline activities.