Guardant Health, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Guardian Health Q2 2020 earnings conference call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. To ask a question via the telephone line, please press star and the number 1 on your telephone keypad. I would like to now hand the call over to your speaker today, Ms. Carrie Mendeville, Investor Relations. Thank you. Please go ahead, ma'am.

Thank you. Earlier today, Garden Health released financial results for the quarter ended June 30th, 2020. If you've 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. 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 regarding the 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 31st, 2019 and in its other filings with the Securities and Exchange Commission. Except as required by law, Thanks, Keri. Good afternoon and thank you for joining our second quarter 2020 earnings call.

Joining me today is Amir Ali Talasaz, our president and co-founder, and Dara Khurshid, our chief financial officer. To start, I hope everyone is in the best of health and in good spirits in the face of the pandemic. As expected, the impact of COVID-19 created headwinds for the oncology space during the second quarter, and not surprisingly, various aspects of our business were affected to varying degrees, which I will review in a bit. That said, in the face of these ongoing challenges, The GARDEN team has continued to make substantial progress across our business, presenting new data for our Lunar 2 assay, announcing two new companion diagnostic partnerships, and launching our GARDEN-informed platform. Indeed, these past few months have made me more confident than ever in the promise of our platform and the significant opportunity ahead to transform patient care despite the challenges posed by the pandemic today. I am extremely proud of the Darden team for the fire and dedication they have shown in this new environment. The fuel to the fire, so to speak, is our commitment to serve patients. And consistent with these values, I will start off our call with a patient story. Recently, a 60-year-old man presented with a brain mass, an initial workup at endometriosis. Unfortunately, his oncologist, who practices in the community setting, I've noticed that patients are coming in at more advanced stages due to delays in addressing symptoms as a result of a pandemic. The brain mask was the most urgent matter for this patient and brain surgery was performed. The provider was suspicious of lung cancer given the histology of the brain biopsy and the presence of lung nodules, but a lung biopsy following the brain procedure was deemed too risky. His oncologist, meanwhile, tissues from his brain biopsy was sent out for genomic testing They were still awaiting results. The provider decided to try liquid biopsy and sent the GARDEN360 as the GARDEN360 user. GARDEN360 quickly identified a methexon 14 skipping alteration. Based on this result, the oncologist was able to select capimatinib for his first-line treatment. Not only does this story demonstrate the importance of the precision oncology paradigm, but it highlights how our liquid biases platform is uniquely qualified to address the needs of patients during this challenging time. Turning to our business, we ended the second quarter with revenue of 66.3 million, growing 23% over the second quarter of 2019. Clinical volumes for GARDEN360 grew 15% to 13,694 clinical tests in part of the second quarter of 2019. On our last earnings call, I shared that our U.S. clinical volumes were down about 30% exiting the first quarter compared to the average level of clinical samples over the first quarter. In May, we had begun to see a slight uptick in sample volume from the lowest points in early April. We continue to see improvement in clinical volumes throughout May and into June and are pleased to report that we exited the quarter with volumes similar to the levels we saw in mid-March from COVID-19. Through this difficult time, our team was not only able to maintain uninterrupted operations, but was also able to consistently maintain our industry-leading turnaround time for Garden 360 of seven days or less. Diving deeper into clinical volumes, growth recovered more quickly in community hospitals compared to the academic setting. Additionally, we saw a rapid shift towards telemedicine. Before the pandemic, we used telemedicine with just a few percent of visits performed virtually. Over the past few months, this trend has reversed itself to protect advanced cancer patients, an extremely high-risk population, from exposure to COVID-19. As a result, there have been fewer physical visits to oncology offices and fewer new diagnoses, factors that benefit the increased use of liquid biopsy testing, Thank you for joining us. This is counterbalanced by 29% year-over-year growth in development services revenue of $15.3 million. On the whole, we remain pleased with our biopharmaceutical business. AmirAli will give further detail in a few minutes. We remain unwavering in our commitment to serving patients in advanced cancer settings and have continued to shift the market to a blood-birth paradigm for genotyping. At the end of 2018, we outlined three key catalysts that would be critical to shifting the market to a blood-first paradigm. First, demonstrating concordance between liquid biopsy and tissue testing. Second, pan-cancer Medicare coverage. And finally, FDA approval of GAR-360 with a pan-cancer tumor profiling label. In the first quarter, we began to see benefits from pan-cancer Medicare payments outside of non-small cell lung cancer. and we are looking forward to achieving the third for all solid tumor types. We believe FDA approval will help to accelerate wider adoption of guideline-recommended genomic profiling, increasing 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 existing Medicare coverage, Extend momentum for our companion diagnostics business through increased opportunities to work with biopharma in the clinical settings. And over the medium to long term, advance the use of GARDEN360 with physicians who have been slow to adopt PGP. Looking ahead, we continue to believe that the unique opportunity we have here at GARDEN will allow us to serve patients with the disease. During the quarter, we completed a follow-on offering, raising approximately We intend to use these funds to accelerate development in our lunar program and pursue the large market opportunities in front of us. I am incredibly proud of the outstanding efforts across our organization, and the last few months only reaffirm my belief that we will come out of this period even stronger as a company. With that, I will now turn the call over to Amir Ali for more detail on our biopharma business and our lunar program.