Guardant Health, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Garden Health Q3 2020 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 on your telephone. If you wish to address your question, press the pound key. I would now like to turn the conference over to your speaker today, Carrie Mandeville with Investor Relations. You may begin.

Thank you. Earlier today, Garden Health released financial results for the quarter ended September 30th, 2020. 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, co-founder and chief executive officer, Amir Ali Talasaz, co-founder and president, and Derek Bertacci, chief financial officer. Before we begin, I'd like to remind you that management will make statements during this call that are 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. Additional information regarding these risks and uncertainties appears in the section entitled Forward-Looking Statements in the Press Release Garden Issue today. For a more complete list and description, please see the Risks Factors section on the company's annual report on Form 10-K for the year ended December 31, 2019, and in its other filings of the Securities and Exchange Commission. Except as required by law, Thanks, Carrie. Good afternoon and thank you for joining our third quarter 2020 earnings call.

During the quarter, we continue to make substantial progress across our business, driven by our commitment to serve patients. Consistent with these values, I will start off our call with a patient story. A 44-year-old non-smoker was diagnosed with stage 4 adenocarcinoma, a type of non-small cell lung cancer. His oncologist originally ordered a limited panel tissue test, but he was confirmed negative for EGFR-L cross 1 and PD-L1. So his oncologist selected chemotherapy plus pembrolizumab for first-line IO treatment despite not having complete biomarker testing. However, the patient failed to respond to treatment and was being considered for hospice. Fortunately, his oncologist then decided to try liquid biopsy for a complete genomic assessment of his tumor and ordered a GARDEN360 test. We quickly identified a BRAF mutation. Based on this result, the oncologist was able to put him on a corresponding targeted therapy, a combination of deprafenib and tramadinib for treatment. His story demonstrates the importance of the precision oncology paradigm. It underscores the challenge of using tissue to get guideline-complete genotyping and how our liquid biopsy platform is uniquely qualified to address the needs of patients at all progression time points. Turning to our business, we ended the third quarter with $74.6 million of revenue, growing 23% over the third quarter of 2019. Clinical volumes for Garden360 grew to 16,950 tests, a 28% increase compared to the third quarter of 2019, and a 24% increase compared to the second quarter of 2020. Returning back to the levels we saw in mid-March, pre-pandemic, I am proud of the Garden team, to continue to successfully serve our customers despite the challenging backdrop. However, over recent weeks there has been a resurgence of COVID cases in some regions across the United States. We are seeing some early signs indicating that this resurgence will adversely affect clinical volumes as renewed or continued office closures are resulting in overall reduced in-person cancer patient visits and limited access. During the quarter, FDA approval of GARDEN360 CDX helped us achieve a key catalyst for adoption of comprehensive genomic profiling in patients with any solid tumor cancer and as a companion diagnostic to identify non-small cell lung cancer patients with EGFR alterations who may benefit from treatment with Tegresso. This approval is a landmark decision demonstrating the value liquid biopsy delivers to oncologists and more importantly to the patients they treat. We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test. FDA approval of the Garden360 CDX assay was based on multiple studies comprising more than 5,000 samples and represents what we believe to be one of the most rigorous validations of the clinical and analytical performance of a liquid biopsy test. Following FDA approval, we launched two versions of Garden360 in September. The first product, Garden360 CDX, is the FDA-approved version of our assay. We are confident that our FDA approval will help to accelerate wider adoption of guideline-recommended genomic profiling and increase the number of advanced cancer patients who receive potentially life-changing treatments. Specifically, we expect FDA approval to strengthen reimbursement by advancing conversations with private payers and further improving Medicare pricing, extend momentum for our companion diagnostics business, and advance the use of GARDEN360 with physicians who have been slow to adopt comprehensive genomic profiling over the medium to long term. The second product we launched is the next generation version of our Garden360 Laboratory Developed Test or LDT that doubles down on our commitment to continue innovating in this space and offer additional biomarkers to our customers as they become relevant. This exciting new version provides even higher performance than previous versions of Garden360. It includes additional Homologous Repair Deficiency Gene in an effort to keep up with the continued expansion in the PARP inhibitor space, NTRK2 and NTRK3 fusions, and a Best-in-Class Tumor Mutational Burden, or TMB, score, which was recently approved in tissue as a biomarker for pembrolizumab for solid tumor patients who have progressed following prior treatment. are blood-based TMB assays highly differentiated and built upon deep sequencing of two megabases of genomic content. It uniquely integrates information about tumor shedding levels, somatic driver alterations, and chip mutations to provide a robust TMB score that can help identify more patients than other TMB tests. This product offering allows us to address the barrier of confidence in liquid biopsy among some late adopters with an FDA approval and the opportunity to provide enhanced features to those customers who are regularly using liquid biopsy in clinical practice. Overall, I could not be more proud of the Garten team for the progress made this year. It's hard to believe it was only a little over two years ago when we became a public company and broadly presented our vision to address the continuum of cancer care for screening to recurrence monitoring through therapy selection with a portfolio of practice-changing products. There is clearly a growing appreciation of this vision and a growing realization of the potential of liquid biopsy to truly transform the field of oncology. Since our IPO, we have made incredible progress establishing liquid biopsy as a vital clinical tool for therapy selection in advanced cancer patients. Achievement of several key milestones, including securing reimbursement, have made the $6 billion addressable market attainable as comprehensive genomic profiling becomes standard of care. We have also made significant progress with our lunar programs, aggressively addressing the even larger opportunities in the recurrence monitoring and screening populations. These programs are initially focused on colorectal cancer, which will serve as a beachhead for expansion of monitoring and screening for multiple cancer types. I am confident from recent data that our LUNAR-1 assay for recurrence monitoring is best in class from both a performance and clinical workflow perspective. I am also encouraged by the breakneck speed with which our team is executing ECLIPSE, our colorectal screening trial, and that if successful, will address significant unmet need. With that, I will now turn the call over to Amir Ali for more detail on our biopharma business and our lunar program. Thanks, Helmy.