5/7/2026

speaker
Matt
Conference Moderator

Good afternoon. Thank you for attending the Garden Health Q1 2026 earnings call. My name is Matt and I'll be the moderator for today's call. All lines will be muted during the presentation portion of the call for an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. I'll now have to pass the conference over to our host, Zarek Prashid, VP of Investor Relations. Zarek, please go ahead.

speaker
Zarek Prashid
VP of Investor Relations

Thank you. Earlier today, Gartent Health released financial results for the quarter ended March 31, 2026. Joining me today from Gartent are Helmi El-Tiki, co-CEO, Amir Ali Talasaz, co-CEO, and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, we 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-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures, are available in the press release Garden issued today, as well as in our 10-Q and other filings with the SEC. Garden disclaims 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 call over to Helmi.

speaker
Helmi El-Tiki
Co-CEO

Thanks, Eric. Good afternoon, and thank you for joining our first quarter 2026 earnings call. Starting on slide three, we entered 2026 with significant momentum that accelerated through Q1, driving a remarkable quarter for Garden Health. These results validate our strategic vision of delivering increasingly more actionable insights to physicians and patients across the care continuum. Notably, our commercial flywheel has achieved a new level of velocity, delivering our fastest year-over-year percentage revenue growth in the last five years and surpassing the $1 billion trailing 12-month revenue milestone. This is a testament to the burgeoning scale and long-term durability of our business. Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. A 77-year-old Atlanta resident recently completed a Shield CRC test, The results came back positive and the patient underwent a diagnostic colonoscopy during which a lesion was discovered and biopsied. The lesion was subsequently confirmed to be malignant by pathology. The patient then underwent surgical resection of the malignant lesion which was confirmed to be highly localized. The patient welcomed this news from her oncologist who was further relieved that no additional treatment was necessary. Patient outcomes like this are one of the many reasons we have benefited from accelerating adoption and growth. Turning to our revenue performance in slide four, we had a phenomenal start to 2026, delivering $302 million of revenue in Q1, representing 48% 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 in slide five, oncology revenue growth accelerated to 36% year-over-year, driving Q1 revenue of $205 million. Oncology test volumes rose 47% to approximately 86,000 tests, up from 59,000 in the prior year period. This was the highest year-over-year percentage growth on oncology volume we've seen in nearly three years, with strength across all products. We're excited to see the expanding role of our portfolio across the cancer care continuum. Turning to slide six, our 47% year-over-year volume growth reflects the increasing breadth of our portfolio across both therapy selection and MRD. Garden360 Liquid delivered 30% volume growth year-over-year, while Garden360 Tissue was our second fastest growing product. Smart platform innovation continues to translate directly into volume growth for both products with Infinity AI powering a steady cadence of new clinical applications that are driving deeper adoption among oncologists. We have a strong pipeline of additional smart apps in development, and we look forward to continuing that cadence. Reveal remained our fastest growing product with volumes up over 100% year over year, reflecting strong adoption of Reveal and MRD across indications and enthusiasm for our new therapy response monitoring use case among our customers in its first full quarter post-launch. Moving on to slide seven. With each patient tested, our data treasury continues to deepen and diversify. Our data repository harnesses insights from over 1 million patient samples 500,000 epigenetic profiles across more than 100 tumor types, and each new sample helps compound the breadth and uniqueness of what we can deliver over time. By applying our Infinity AI learning engine to this expanding data mode, we uncover novel biological signatures, power new smart app development, and accelerate therapeutic discovery for our biopharma partners. The result is a compounding flywheel wherein data drives better insights, which in turn fuels volume growth and strengthens our data advantage. Turning to slide eight to take a closer look at our reveal data pipeline. We continue to make strong progress in generating and publishing compelling data across multiple cancer types and indications. We have submitted data packages to MoldDx to support coverage and breast cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring, and we are engaging constructively with MOLD-EX through the review process. Each submission represents a potentially meaningful reimbursement catalyst, and we are excited about the ASP upside that favorable outcomes would unlock. We are also advancing our work towards the MOLD-EX submission for CDK4-6 inhibitor monitoring. Looking further ahead, we have ongoing studies across more than five additional tumor types in both the adjuvant and surveillance settings. The breadth of this pipeline gives us real confidence in Reveal's trajectory and its expanding role across the cancer care continuum. Turning to slide nine, we continue to make strong progress across the GARDEN360 portfolio on multiple fronts. For GARDEN360 Liquid, our FDA review remains on track. When approved, GARDEN 360 liquid will become the most comprehensive FDA-approved liquid biopsy for therapy selection on the market. Moreover, this development will help simplify ordering across our therapy selection portfolio and create better connectivity across our larger testing ecosystem. On the tissue side, we are excited to announce our second major platform upgrade in less than a year, expanding RNA testing to hold transcriptome. This further builds on the genomic and epigenomic foundation of our smart platform, and we believe reinforces Garden360 Tissue's position as best in class in the tissue CGP market. We expect these upgrades to be a meaningful volume catalyst for both liquid and tissue, particularly as it opens the door to converting current non-users. Turning to slide 10, Garden had another strong showing at AACR this year. Together with our independent collaborators, 38 abstracts were presented spanning our entire oncology portfolio. The depth of the smart app data was remarkable. 25 of the abstracts featured Infinity AI-generated findings, which speaks to how rapidly this platform is maturing. We were particularly encouraged to see concrete evidence of Infinity AI enabling therapeutic response prediction and improving detection of clinically challenging alterations like ALK fusions and MTAP deletions. These are exactly the kind of insights unlocked by our data treasury and epigenomic capabilities that truly differentiate our platform. Shifting gears to our biopharma data business in slide 11, we delivered another strong quarter with revenue growing 17% year over year to $53 million. The last few months have been highly productive with respect to our CDX strategy, which included GARDEN-360 CDX FDA approval for Pfizer's Brastovir in BRAS B600E mutant metastatic colorectal cancer. And this week's CDX FDA approval with Arvanus and Pfizer's Vipano for ER-positive HER2-negative ESR1-mutated advanced breast cancer. Our CDX franchise now spans 26 approvals across the U.S., Japan, and Europe, backed by a robust pipeline across multiple partnerships with leading biopharma companies. In the quarter, real-world evidence generated from Infinity AI as supplemental data alongside clinical findings contributed to the first tumor agnostic approval of Daiichi Sankyo's and HER2 in Japan. We also saw further strengthening of our relationships with leading biopharma companies, including a multi-year agreement with Merck to develop companion diagnostics and commercialized novel therapies, as well as last week's announced collaboration with Newvalent to develop companion diagnostics with an initial focus on garden 360 tissue. Together, these developments reflect the growing strategic value of our smart platform and Infinity AI to leading biopharma companies and reinforce our confidence and sustained growth in this business. With that, I'll now turn the call over to Amir Ali for an update on screening.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

Q1GH 2026

-

-

Investor presentation