Guardant Health, Inc.

Garden Health Q2 2025 Earnings Conference Call. My name is Jason and I'll be the moderator today. All lines will be muted during the presentation portion of the call and opportunity for questions and answers at the end. I would now like to pass the conference over to your host, Zarek Hurshid.

Thank you. Earlier today, Garden Health released financial results for the quarter ended June 30th, 2025. Joining me today from GARDEN are Helmi El-Touki, co-CEO, Amir Ali Talitha, 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 gap financial measures which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non gap financial reconciliation to most directly comparable gap financial measures are available in the press release garden issued today, as well as in our 10 K and other filings with the SEC. This claims 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 live call over to Helmi.

Thanks, Eric. Good afternoon, and thank you for joining our second quarter 2025 earnings call. Starting on slide three, Q2 marked another exceptional quarter for Gardent. We continued to build momentum across oncology, biopharma, and screening business lines, including accelerating therapy selection and MRD volume growth, record biopharma sales, and quickly scaling shield volumes and revenues. Product innovation built on smart liquid biopsy, combined with strong commercial execution, were integral to the strong performance in the second quarter. I'll walk through some of the key highlights of the quarter in just a moment, but first, as always, I would like to start with a powerful story that demonstrates the impact our tests can have on patients around the world. Last August, a 46-year-old woman was diagnosed with stage 3 endometrial carcinoma. Once it became clear that her cancer was progressing, her oncologist ordered a GARDEN360 tissue test to help identify potential treatment options beyond the standard of care. Garden 360 tissue had just gone through a major upgrade to incorporate comprehensive DNA and RNA, and oncologists ordered both results. The test identified a retfusion, an actionable biomarker that made her eligible for a targeted therapy she likely would not have received based on her initial diagnosis alone. I'm glad to be able to share that she has responded positively to this treatment and is doing well today. This case is a powerful example of how comprehensive molecular profiling through our recently upgraded GARDEN360 tissue test can help guide treatment decisions and improve patient outcomes. Turning to top line performance in slide four, Q2 revenue grew 31% year over year to $232 million with strong performance across our oncology, screening, and biopharma and data businesses. Starting with our oncology business in slide five, Roughly half of the overall year-over-year revenue growth in Q2 came from the oncology business, with revenue increasing 22% to $159 million. Oncology volumes increased 30% year-over-year to approximately 64,000 tests in the second quarter, with the majority of growth driven by Garden360 Liquid, again closely followed by a strong contribution from Reveal. Looking more closely at some of the recent highlights within our oncology business on slide six, We saw continued volume growth across all oncology tests this quarter, with particularly strong performance from Garden360 Liquid, where year-over-year growth accelerated for the fourth consecutive quarter and was over 20% in Q2. We continue to believe that the steady cadence of new app introductions powered by smart liquid biopsy has been instrumental to the accelerating growth profile of Garden360 Liquid. In late May, as part of the lead up to ASCO 2025, we introduced 11 groundbreaking smart liquid biopsy applications for Garden360 Liquid, significantly expanding the clinical utility and further extending our technical leadership in the liquid CGP market. I'll walk through some of these applications in more detail shortly. Garden360 Tissue continues to be our second fastest growing oncology product and is even better positioned today to accelerate following the major upgrade in April which we believe make it a best-in-class product. As a reminder, the recent improvements expand the panel to include RNA and broad methyloma analysis powered by our smart liquid biopsy platform and enable readouts with 40% less slides than the industry norm, which we believe is an important differentiator. We are also excited to report for the first time that Garden360 Tissue ASB was approximately $2,000 in Q2, achieving our 2028 target three years ahead of schedule. For Reveal, we made great progress with data generation and publications. We recently submitted our Reveal breast cancer data package to MoldyX for Medicare reimbursement, and the first publication of immuno-oncology therapy monitoring data on Reveal was published this week. In May, we continue to augment our offering with the launches of garden hereditary cancer testing and a suite of immunohistochemistry or IHC tests. These additions bring us closer to becoming a one-stop shop for oncologists providing insights across the patient journey. Turning to slide seven. At the annual ASCO meeting in early June, results from the landmark Serena 6 trial, sponsored by AstraZeneca, were featured in a high-profile plenary session. This was the first pivotal trial to use a ctDNA-guided approach to detect and treat emerging resistance in first-line therapy ahead of disease progression in breast cancer. GARDEN360 was the exclusive companion liquid biopsy used in the trial for this monitoring application. Feedback from KOLs during and after ASCO was incredibly positive, and we look forward to chemizestrin potentially becoming a new option for breast cancer patients. This important new paradigm involving frequent GARDEN360 testing in order to quickly detect the emergence of resistance mutations has potential to change clinical practice and improve outcomes for patients with advanced breast cancer. With a prevalence pool of approximately 40,000 patients in the U.S., This new application of GARDEN360 has the potential to drive significant incremental GARDEN360 revenue in 2026 and beyond. Moving on to slide eight, we have built a powerful real-world evidence platform utilizing over 100,000 genomic and broad epigenomic profiles across more than 50 cancer types. By combining the multi-omic profiling capabilities of our INFINITI platform with the analytical power of our INFINITI AI learning engine, we are driving the development of first-of-their-kind clinical applications that are setting a new standard in precision oncology. Turning to slide 9, since July of last year, Garden360 has delivered accelerating growth each quarter, fueled by our Garden Infinity smart liquid biopsy platform. In Q2 alone, we launched nearly a dozen groundbreaking new apps, greatly expanding the utility of Garden360 Liquid. The latest wave of new apps include complementary genomic features which add and even higher resolution view of tumor biology, helping healthcare providers to make smarter, more personalized treatment decisions, even when tissue isn't available for analysis. Among the many newly launched applications are cancer subtype classification using tumor-specific methylation signatures to complement and enhance standard testing methods, cancer site of origin identification when the primary site is unknown, guiding better diagnosis and therapy, advanced negative prediction to confidently identify wildcat patients, and pharmacogenomic profiling to identify genetic variations that impact the safety and efficacy of commonly used anticancer therapies. Now shifting gears to Reveal on slide 10, where we are the leader in tissue-free MRD. Over the last few months, we have continued to generate and publish compelling data on Reveal across a number of cancer types. As I mentioned earlier, The Reveal Breast Reimbursement Submission has been made to MOL-BX, and the IO monitoring study just published will support reimbursement submission for this application in the near future. Starting with slide 11, we were excited to announce a new breast cancer publication in ESMO Open, highlighting the performance of Reveal. This retrospective study evaluated 95 patients who were diagnosed with early-stage ER-positive HER2-negative or triple-negative breast cancer, undergoing chemotherapy prior to surgery. Notably, nearly 40% of patients had minimal or no residual tumor following neoadjuvant chemotherapy, demonstrating the value of Reveal's tissue-free approach. Reveal showed strong performance with 100% sensitivity for distance recurrence in patients with ER-positive HER2-negative breast cancer, 100% specificity, and 100% positive predictive value for relapse, and an overall sensitivity of 71%. These results, combined with the data recently published in clinical cancer research, further validate Reveal's potential to transform neoadjuvant and post-treatment surveillance strategies with the ultimate goal of improving patient outcomes. Moving on to slide 12, I am proud to share the Radiohead Reveal Immuno-Oncology Monitoring Study, which involved 521 stage 4 pancancer patients treated with standard-of-care immunotherapy, was published in Cancer Research Communications a journal of the American Association of Cancer Research. This study demonstrated that any decrease in reveal tumor fraction signal in the study was significantly associated with improved patient outcomes. Additionally, reveal identified nonresponders more than three months and as many as five months before disease progression was visible in standard imaging. Turning to slide 13. At this year's ASCO Annual Meeting, data from the largest study to date using ctDNA in stage 3 colon cancer further validated the clinical utility of Reveal. This phase 3 study involved over 2,000 patients evaluated with a median follow-up of 6.1 years showed that ctDNA detected after surgery and before chemotherapy is a powerful predictor of recurrence and survival. Among patients with detectable ctDNA, 63% experienced recurrence within three years compared to just 15% of those without detectable CTDNA. These findings strongly support the routine use of garden reveal to stratify patients by risk, inform adjuvant therapy decisions, and ultimately improve outcomes. We have made strong progress over the last few months in MRD. Reveal volume growth accelerated in the second quarter on a year-over-year basis, consistent with our expectations, and we continue to have an extensive pipeline of clinical cohorts to further support clinical utility and analytical validity for Reveal. Turning now to slide 14, our oncology business is well positioned for durable growth supported by continued CGP penetration, favorable ASP dynamics, and international expansion. Garden360 Liquid and Garden360 Tissue are seeing increased adoption driven by the recently expanded genomic and epigenomic breadth of our platform, which is unlocking greater clinical utility and driving share gains. With a redoubled commercial focus on reveals following major COGS improvements and Medicare CRC surveillance reimbursement earlier this year, the business is primed for strong growth in MRD. Looking more closely at some of the recent highlights within our biopharma and data business in slide 15, we delivered a record quarter for our biopharma business, achieving all-time highs in both volume and revenue, with second quarter revenue growing 28% year over year. We continue to deepen our relationship with large pharma and sign two new companion diagnostic deals in Q2. We continue to have a robust and growing pipeline of partnerships, and near-term revenue visibility remains high. Of note, our biopharma volume mix continues to skew towards methylation analysis on Infinity powered by our smart liquid biopsy platform. With that, I will now turn the call over to Amir Ali for an update on screening.