Guardant Health 2026 Q2 Earnings Call

Good afternoon. Thank you for joining our second quarter 2026 earnings call. Starting on slide three, the platform we have built at Guardant is enabling four of the largest opportunities in precision medicine: therapy selection, recurrence monitoring, cancer screening, and ultimately, multi-disease screening. Together, these represent nearly $400 billion in potential markets, all powered by the same Smart Platform and the compounding technology data and clinical insights it generates across the disease continuum. Q2 was a landmark quarter in advancing that vision. During the quarter, we received FDA approval for Guardant360 Liquid CDx, as well as approval for a higher throughput, lower COGS Shield workflow. In addition, we achieved two significant Shield milestones, inclusion in the American Cancer Society's colorectal cancer screening guidelines, and just this month, a major coverage decision from UnitedHealth Group.

Together with continued broad-based growth across the business, these results demonstrate that we are steadily turning our Smart Platform vision into clinical impact and durable growth. Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. Maria was a 46-year-old mother of two living with metastatic breast cancer. After surgery, chemotherapy, endocrine therapy, and later progression on multiple lines of treatment, her care team faced a familiar but frustrating question. What next? Her disease had become harder to control. Tissue was limited from prior biopsies and may not be representative of her current disease. Another invasive procedure would have delayed treatment decisions. Her oncologist ordered a Guardant360 Liquid test to provide a comprehensive real-time view of her cancer through a blood draw. The results changed the conversation.

Guardant360 Liquid identified homologous recombination deficiency, or HRD, which occurs when cells lose their ability to accurately repair double-stranded DNA breaks. Armed with this new biological insight, Maria's care team had greater confidence that her cancer may be more responsive to a DNA damage response strategy as opposed to another empiric chemotherapy. Maria's oncologist shifted her treatment plan to a biomarker-informed approach that included platinum-based therapy, which she responded well to with manageable side effects. Turning to our revenue performance on slide four, we delivered $335 million of revenue in the second quarter, representing 44% year-over-year growth. The growth was strong and broad-based across our oncology, Biopharma and data, and screening business lines. Taking a closer look at our oncology business on slide five, oncology revenue grew 38% year-over-year, driving Q2 revenue of $219 million.

Oncology test volumes rose 63% to approximately 104,000 tests, up from 64,000 in the prior year period, with strength across all products. Turning to slide six, the tremendous 63% growth in oncology volume represented another quarter of acceleration, reflecting the increasing strength of our portfolio across both therapy selection and MRD. Guardant360 Liquid year-over-year volume growth accelerated from the first quarter, delivering greater than 30% growth, benefiting from continued Smart Platform adoption. Guardant360 Tissue volume growth also accelerated in the quarter and remains our second fastest-growing product. Reveal continues to be our fastest-growing product, with volume growth accelerating again to more than 100% year-over-year, reflecting continued strength in MRD and growing adoption of the therapy monitoring use case. Moving to slide seven, I wanted to spend a moment on what we believe is one of our most underappreciated assets, our data.

Every patient we test deepens a proprietary data asset that is difficult, if not impossible, for others to replicate. Today, that repository spans more than 1.3 million patient tests and over 700,000 epigenetic profiles across more than 100 tumor types. This is the raw fuel that powers InfinityAI, enabling the discovery of novel biological signatures, the development of new clinically actionable Smart Apps, and the acceleration of drug discovery for our Biopharma partners. At ASCO in June, we showcased several innovative new tools built on our InfinityAI platform, and we are seeing a very strong positive response. Turning to slide eight. In May, we received FDA approval for Guardant360 Liquid CDx, the most advanced FDA-approved liquid biopsy panel, with 100 times more content versus our legacy FDA-approved CDx product. Guardant360 Liquid CDx is significant for several reasons.

Most notably, it reinforces Guardant's leadership in the field of liquid CGP testing, with Guardant360 Liquid CDx representing the only FDA-approved liquid biopsy test integrating both genomic and epigenomic content. Over time, Guardant360 Liquid CDx will help to simplify our therapy selection portfolio by consolidating multiple offerings into a single product. We are also excited by the potential for Guardant360 Liquid CDx to complement Guardant360 Tissue to drive greater adoption. We remain on track to obtain ADLT designation for Guardant360 Liquid CDx in the first half of 2027. In June, we began a phased rollout of Guardant360 Liquid CDx to our U.S. customers, and we plan to offer widespread availability of the test following ADLT designation. This approach is intended to ensure a smooth reimbursement transition to the new test.

The FDA approval in the second quarter represents one of the most significant regulatory milestones in our company's history, and the feedback from customers thus far has been incredibly strong. Turning to slide nine. Reveal continues to perform at an extremely high level, with volume growth accelerating for the third quarter in a row to well above 100% year-over-year. We believe Reveal remains the most validated and highest performing tissue-free MRD solution with a five-day turnaround time. Once again, we experienced strong MRD uptake in the second quarter across major indications, and Reveal therapy monitoring continues to stand out as a major volume growth driver in its second full quarter after launch. Reveal is uniquely suited for therapy monitoring in late-stage cancer, helping predict therapy response months before imaging, and with seamless connectivity to Guardant360 Liquid. It can help physicians to act sooner and with more precision.

Late-stage cancer therapy monitoring alone is a multimillion test annual opportunity that remains largely untapped. We continue to be excited about the commercial momentum behind Reveal, and we remain on track to launch Reveal Ultra later this year, which we believe will be the most sensitive tumor-informed MRD test. Turning to slide 10. We continue to make progress advancing our Reveal data and publication pipeline. As a reminder, we have submitted data to MolDX for coverage for breast cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring, and those initiatives continue to progress. Shifting to our Biopharma and data business in slide 11. Revenue grew 9% year-over-year to $61 million, which marks a record quarter. Our companion diagnostic franchise continues to build momentum. We now have 28 CDx approvals, with four added in the first half of this year alone.

This reflects the strategic value of our Smart Platform to leading biopharma companies. During the quarter, we received FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, the first targeted therapy approved for adults with HER2 or ERBB2 mutant advanced non-small cell lung cancer as an initial treatment option. We also received FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer's VEPPANU for ER-positive, HER2-negative, ESR1 mutated advanced breast cancer. We also announced a collaboration with Nuvalent to develop companion diagnostics with an initial focus on Guardant360 Tissue. With that, I'll now turn the call over to AmirAli for an update on screening.

Thank you, Helmy. Moving on to slide 12. We developed Shield from the ground up as a multi-cancer detection platform. Shield is clinically validated for detection of 10 different cancer types and is approved by the FDA for colorectal cancer screening as its first indication. When a physician orders a Shield blood test for CRC screening, they can opt in to receive multi-cancer detection results report covering 9 additional cancer types beyond CRC. The release of this report is contingent on patient authorizing the release of their medical records to Guardant as part of our data collection initiative. We are very pleased with the progress in multi-cancer data collection and are excited to see the majority of Shield ordering physicians opting in to receive MCD reports. With colorectal cancer screening still representing such a significant unmet need, CRC remains our primary commercial focus.

Now, moving on to slide 13 for an update on the screening business. Q2 was another fantastic quarter for Shield. We delivered $53 million of Shield testing revenue, driven by approximately 66,000 tests, compared to $15 million of revenue on approximately 16,000 tests in Q2 of 2025. Turning to slide 14, which shows the evolution of Shield sales over the last eight quarters, overlaid with the important guidelines, commercial partnerships, and coverage wins that have been instrumental in driving recent demand and that gives us confidence in future growth. I will discuss a few of these significant wins in greater detail shortly. We are now well into our second year of commercial launch, and the business continues to fire on all cylinders. Moving on to slide 15 to discuss our major screening highlights.

We saw exceptionally strong volume growth in the quarter, driven by commercial scale, DTC momentum, and our Quest Diagnostics collaboration. Shield was included in the American Cancer Society's Colorectal Cancer Screening Guidelines, making Shield the only FDA-approved blood test included in both ACS and NCCN guidelines. UnitedHealth Group, the largest commercial insurer in the United States, announced it will begin covering Shield for colorectal cancer screening in adults 45 and older. Moreover, we are excited to report that last week we received FDA approval for a higher throughput, lower COGS Shield workflow. Let's focus on the latest scaled Shield commercial engine on slide 16. Shield's commercial reach continues to expand rapidly on personal promotion campaigns, health system engagements, and EMR connectivity. We are happy to report that our field organization now stands at over 400 professionals nationwide.

In addition to our internal sales team, the Quest collaboration has been a success. We are encouraged with how nationwide EMR access and co-promotional activities with their team have developed in the first full quarter since the relationship went live in the field. In addition to these initiatives, we have built and expanded our dedicated health system team to more than 30 people and have been encouraged by the engagement within large accounts. Turning to slide 17. Patient access to Shield blood test continues to expand at a rapid rate. Shield was added to the NCCN guidelines in June 2025 and to the American Cancer Society guidelines in May 2026. ACS guideline inclusion is particularly important because it triggers state-level coverage mandates in roughly a dozen states for commercial payers.

An exciting result of these guidelines wins has been positive momentum in our payer discussions and the sooner than expected UnitedHealth coverage policy update that I mentioned earlier. This coverage will be effective starting on August 1st, which includes Shield as a covered primary colorectal cancer screening option for average-risk adults age 45 and older. UnitedHealth is the largest commercial insurer in the U.S. and the first major insurer to cover Shield. Turning to slide 18. To put these commercial coverage wins into context, there are approximately 120 million average-risk individuals in U.S. eligible for colorectal cancer screening, representing a $50 billion U.S. addressable screening market. As a result of ACS guideline inclusion and the UnitedHealth coverage policy, we believe that approximately 70 million lives or roughly 60% of the market is now covered for Shield blood tests. Turning to slide 19. Last week, we received FDA approval for a higher throughput, lower COGS Shield workflow, that workflow will be live in production in August for all new incoming samples.