Guardant Health, Inc.

Hello and welcome to the GardenSelf Q3 2021 earnings call. My name is Alex and I'll be coordinating the call today. If you would like to ask a question at the end of the presentation, you can press star 1 on your telephone keypads. If you wish to withdraw your question, you can press star 2. I will now hand it over to your host, Carrie Mendeville, Investor Relations, to begin. Over to you, Carrie.

Thank you. Earlier today, Garden Health released financial results for the quarter ended September 30th, 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 are Helmi Altuke, co-CEO, Amirali Talazaz, co-CEO, and Mike Bell, 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 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 release submitted to the SEC. Except as required by law, GARDEN disciplines 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, November 4th, 2021. With that, I'd like to turn the call over to Helmi.

Thanks, Carrie. Good afternoon, and thank you for joining our third quarter 2021 earnings call. I'll start off today's call by highlighting our progress across oncology as we continue to build on our strong foundation as a liquid biopsy leader. I will then turn the call over to Amir Ali, for an update on our screening program in colorectal cancer and our plans for expansion into multi-cancer screening. And finally, Mike will provide a more detailed look at our financials and our outlook for the remainder of 2021. Our mission at GARDEN is to conquer cancer with data fueled by a commitment to putting patients first. To this end, we are dedicated to bringing the absolute best products to market that will provide clinically actionable information to inform patient care. Before I provide an update on our progress, I would like to start the call off with a patient story. This past summer, a 64-year-old woman was diagnosed with colorectal cancer. Her oncologist ordered a GARDEN360 CDX test, which identified her cancer as KRAS negative, indicating that she may respond to anti-EGFR therapy. With this information, she was enrolled in a clinical trial. As her treatment progressed, she began to experience worsening symptoms that led to uncertainty about whether or not she was responding to treatment from the clinical trial. Her oncologist ordered a GARDEN360 response test, which is the first commercially available, but only liquid biopsy test that detects changes in circulating tumor DNA levels to provide an early indication of a patient's response to treatment. The test confirmed her cell-free tumor DNA levels were decreasing, meaning she was indeed responding to treatment, and her symptoms were likely a side effect from the therapy. With this, her oncologist had the information he needed to continue treatment through the trial, and the patient's symptoms have since improved. This story highlights how Garden360 can provide powerful information across multiple stages of cancer care, from rapid treatment selection with our Garden360 CDX to early treatment response monitoring with Garden360 Response. Today, the Garden360 product portfolio is increasingly providing oncologists with a set of comprehensive tools to unlock the full potential of precision oncology across the continuum of advanced cancer care. Now turning to our performance. We realized record revenue during the third quarter of approximately $95 million, growing 27% year over year. On our earnings call in early August, we share that the resurgence of COVID-19 cases was impacting oncology office visits and Salesforce access. with our international business particularly impacted. While the environment didn't worsen, these impacts persisted through August and into September. Despite these continuing impacts from COVID, our team delivered strong clinical volumes of 22,806 tests, up 9% from the second quarter of this year, and 35% compared to the prior year. I continue to be proud of how well our commercial team is executing in this environment and achieving healthy volumes and continued growth. Notably, approximately 60% of our volume in the quarter came from the community setting, which represents over 10% growth over the previous quarter. We have also continued our strong cadence of clinical evidence supporting GARDEN360. In September, we shared new data at ISLAC World Conference on Lung Cancer that demonstrated the advantages of using the GARDEN360 liquid biopsy test for clinical decision making in advanced lung cancer. Shortly after, we showed data at ESMO highlighting molecular targets of importance, treatment resistance patterns, and advantages of the GARDEN360 liquid biopsy test to help improve the management of advanced solid cancers. These studies add to the growing evidence demonstrating that GARDEN360 is an easy and quick way to identify more patients with actionable biomarkers, allowing clinicians to start biomarker-informed treatment sooner as compared to tissue biopsy for comprehensive genomic profiling. Turning to recurrence monitoring. We are encouraged by the growing interest and early success of garden reveal and are continuing to invest heavily in the vast opportunity ahead while leveraging our existing channel with oncologists. We now have a full commercial channel dedicated to reveal and have added over 50 employees to the team during the third quarter. Across our oncology portfolio, we have a commercial organization of more than 250 employees across sales, marketing, and medical affairs. We are making solid progress towards our multi-cancer goal with data on colorectal cancer, as well as bladder, lung, and breast indications. Similar to our approach in therapy selection, we are investing in clinical studies across MRD to demonstrate the clinical utility of our tests. To that end, in October, we initiated the Oracle study to evaluate the performance of Gardner Veal to predict recurrence across many early-stage cancers. Specifically, this is a thousand patient prospective observational multicenter study designed to evaluate the performance of Reveal to predict cancer recurrence after curative intent treatment across 11 solid tumor types. This study, in combination with their existing studies, would establish clinical evidence for Gardner Reveal across nearly 80% of all solid tumor cancers. The first patient was enrolled in early October. If successful, Oracle will pave the path for reimbursement for garden reveals across multiple cancer types, definitively establishing the blood-only approach for MRD and unlocking the $15 billion total addressable market for MRD across all tumor types. Moving on to biopharma, we saw a healthy rebound in our biopharma business with volume of 4,839 samples, up 32% from the second quarter, and up 58% year over year. We are seeing growing interest with our biopharma partners for using Reveal in the adjuvant setting with non-CRC indications such as lung, bladder, and breast. Our partners are seeing significant benefits with our blood-only, tissue-agnostic approach, and we look forward to growing usage of Reveal in the biopharma setting. In addition to increasing sample volumes, the number of customers we serve continues to grow. We now have more than 90 active biopharma partnerships with a healthy pipeline and we expect to have more than 100 partners by the end of the year. The breadth of our product offering, strong customer service, and clinical market leadership makes us an attractive partner. Outside of the United States, we continue to expand our presence in Europe through established partnerships with premier cancer organizations. We have partnered with the Royal Marsden, a leading specialist treatment hospital in London. This is similar to the previously announced Valdebron Partnership in Spain, which establishes in-house liquid biopsy testing services running garden 360 tests and sequencing onsite. This service is expected to become operational in 2022 and will be available for clinical research and clinical care, providing industry-leading next-generation sequencing to private and self-paying patients with a plan for future expansion for national health service patients. In addition, we continue to make important progress with our JV in Asia, the Middle East, and Africa. Specifically in Japan, we are on track for PMDA approval of GARDEN360 and launching our clinical laboratory outside of Tokyo by early next year. We are also making excellent progress in other countries in the region, as well as growing clinical volumes with both pharma customers and oncology clinics. Accordingly, we have decided to exercise our call right to purchase the remaining 50% of our joint venture from South Bank. We are working towards a future where all patients with cancer around the world have access to the latest innovations to inform treatment decisions and managed care for the best possible outcomes. This additional partnership in Europe and our redoubled commitment to our efforts in Asia, Africa, and the Middle East are important steps towards realizing that vision. Finally, before I turn the call over to Amir Ali, I wanted to take a moment to welcome Myrtle Potter to our Board of Directors. Myrtle currently serves as chief executive officer and board member of Sumito Vent Biopharma. Prior to Sumito Vent, Myrtle served as the president of commercial operations at Genentech. Myrtle has previously served on the boards of Amazon, Express Scripts, Medco Health Solutions, Everyday Health, among others. Her extensive knowledge and experience bringing the world-class healthcare products to market will be invaluable as we scale our organization. As GARDEN grows, I continue to be amazed by the incredible talent we are bringing on board, joining our efforts to bring the best products to market as we strive to provide patients across all stages of cancer with access to the latest advancements in precision oncology. I will now turn the call over to Amir Ali to provide an update on screening.