8/10/2026

speaker
Operator
Operator

Good day, and welcome to the BioNano Second Quarter 2026 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Webb Campbell from Gilmartin Group. Please go ahead.

speaker
Webb Campbell
Gilmartin Group

Thank you, operator, and good afternoon, everyone. Welcome to the BioNano Second Quarter 2026 Financial Results Conference Call. On the call today are Dr. Al Luterer, Chairman and Interim CEO of BioNano, and Mark Adamchak, BioNano's Vice President of Accounting and Principal Accounting Officer. After market closed today, BioNano issued a press release announcing its financial results for the second quarter of 2026. A copy of the release can be found on the Investor Relations page of the company's website. Certain statements made during this conference call may be forward-looking statements. Actual results may differ materially from such statements due to several factors and risks, some of which are identified in BioNano's press release and BioNano's report filed with the SEC. These forward-looking statements are based upon information available to BioNano today, August 10, 2026, and the company assumes no obligation to update statements as circumstances change. During our call, we may reference certain non-GAAP financial measures, which we believe provide useful information for investors. Reconciliations of these measures to GAAP can be found on our press release and slide deck. An audio recording and webcast replay of today's conference call will also be available online on the investor relations page of the company website. With that, I will turn the call over to Al.

speaker
Dr. Al Luterer
Chairman and Interim CEO, BioNano

Well, thank you, Webb, and good afternoon, everyone. I'm pleased to be here with you all today to share our second quarter 2026 results. BioNano had a strong second quarter, and that strength can be directly attributed to increased adoption by our customers. Our results reflect a vote of confidence from our routine use customer community and the accelerating global adoption of Optical Genome Mapping, or OGM. Importantly, the growth of our consumable sales this quarter was primarily driven by increased clinical adoption. We expect that adoption, together with increased utilization at existing and new clinical sites, to remain the foundation of our growth. Now, before I get into the quarter, I want to note an important addition to our team. We're pleased to welcome back Dr. Alex Hastie as our Chief Scientific Officer. Alex was one of the original architects of our technology. He spent 14 years building BioNana's leadership in OGM, and he's widely regarded across our community as, and I quote, Mr. Optical Genome Mapping. His return underscores our commitment to scientific leadership as we expand the commercial and clinical research applications of our platform. I also wanted to provide a very brief update on the ongoing search for my replacement. I'm working in lockstep with the board to identify the best candidate to take BioNano into its next stage of growth. Until then, I remain solely committed to BioNano, our customers, employees, and our shareholders. Now, as a reminder, our focus remains on transforming pathology, the discipline that investigates the causes, developments, and effects of disease. Legacy analog workflows are tedious, slow, costly, and labor intensive. We are spearheading a shift to streamlined digital workflows built on technology and platform consolidation, automation, and the AI-driven software behind our products and solution. Today, I'll walk through the progress we're making against our strategy to transform pathology. I want to briefly recap the framework that continues to guide our execution. Beginning in September 24, we deliberately redirected our focus away from aggressive installed base expansion towards driving profitable growth with existing routine users. We are achieving this by being selective about new customer acquisition, prioritizing prospects most likely to become routine high volume users. Four strategic pillars define how we have and we'll continue to execute against that framework. First, to support and sustain our installed base of routine OGM and VIA software users. Second, to increase OGM utilization by routine users by supporting menu expansion and improving ease of use with VIA and ionic adoption. Third, to build the support needed for OGM reimbursement and inclusion in medical society guidelines and recommendations. And fourth, to improve profitability and scalability through lower costs, higher volumes, and continuous improvement in product quality. Turning to our first and second pillars, which are focused on supporting our install base and driving greater utilization of our products, Q2 2026 slow sales sold were up 27% year-over-year at a record 9,219 units. Demand continues to outpace our supply, although we are making progress working down our backlog. Removing flow cells tied to sales of new OGM systems in both periods, flow cells sold to existing customers were up 24% year-over-year in Q2. Simply put, our customers are running more samples and much of that pull-through reflects increasing clinical adoption of OGM. Breaking down our revenue segments, consumable revenue was 4.3 million in Q2 26, up 30% year-over-year. That growth came primarily from an increase in the number of flow cells sold, consistent with the clinical adoption trend I just mentioned, the clearest evidence of our strategy in action. Software revenue was 1.4 million in Q2, down 16% year-over-year, reflecting timing delays in deployment from certain customers. Other revenue, which includes instruments and services, was $2.5 million in Q2 26, up 38% year-over-year, led by higher instrument sales as new customers came onto the platform. This ongoing shift towards a higher proportion of recurring, consumable-led revenue reflects a healthier, more predictable business mix in our view and is directly aligned with our strategy. I'd also note that the international markets continue to be a key growth driver in the quarter, with international revenue now representing the majority of our total revenue. We attribute this to broadening clinical adoption at leading European institutions. Regarding our second pillar, driving greater utilization of our products, we ended the quarter with 397 OGM systems installed worldwide, up 5% from 378 a year ago. At the same time, Flow cells sold were up 27% year-over-year at 9,219 units, a record for any quarter, even as demand continues to outpace what we can currently supply. Together, these two data points capture exactly what we're focused on, meaningfully deepening flow cell utilization within a robust footprint of OGM systems. Expanding on the second pillar, increasing OGM utilization by supporting software adoption and menu expansion, we continue to receive very positive feedback on our software and compute upgrades, which enable customers to expand their menus and increase utilization, in some cases doubling weekly cancer sample throughput without any hardware change. VIA's reach extends well beyond OGM. It remains the gold standard for CNV analysis on microarrays, and adoption among NGS and long read sequencing labs continues to grow. These non-OGM VA users represent both a durable software revenue stream and a natural entry point into broader bio-nano adoption. We also continue to develop and support our ionic system, which represents a fundamentally different approach to nucleic acid purification. Rather than relying on the bead and column based binding and washing steps that have defined the space for the last two decades, ionic separates and concentrates DNA and RNA directly in solution. We are specifically expanding ionics capabilities to interface directly with sample preparation for OGM and long read sequencing with the OGM expansion targeted for launch in Q4, 2026. In our view, it will be an important contributor to incremental consumables revenue and deeper customer relationships, supporting the higher margin recurring revenue mix at the center of our long-term growth strategy. Now, regarding our third pillar, building support for OGM reimbursement and inclusion in medical society guidelines, the two Category 1 CPT codes that took effect earlier this year covering OGM and hematologic malignancies at $1,853.22 and OGM in constitutional genetic disorders at $1,263.53 now cover OGM's primary application areas and represent significant reimbursement infrastructure supporting routine adoption. What we are increasingly seeing this year is reimbursement infrastructure translating into real clinical adoption and utilization, which is, of course, the engine behind our consumable growth. This development continues to reduce barriers to adoption and pave the way for even more routine use of OGM across oncology and clinical genetic research communities globally. On the publications and evidence front, momentum continues in the second quarter, and the evidence base is increasingly clinical in nature. First, in May, we announced the largest OGM study of T-cell acute lymphoblastic leukemia, or TALL, to date, published in Modern Pathology and conducted by researchers at the University of Texas MD Anderson Cancer Center and Johns Hopkins University School of Medicine. Across 91 cases, OGM detected genomic abnormalities in 97.8% of cases, compared to just 55% by conventional karyotyping. and delivered clinically relevant genomic information beyond karyotyping in approximately 70% of cases, all from a single workflow. TALL is an aggressive blood cancer where roughly half of cases remain unsolved by legacy methods, and this study demonstrates how well suited OGM is to that challenge. Second, we announced multiple 2026 publications describing the unique utility of OGM in reproductive health and prenatal genetic disorders, with 13 studies analyzing 730 subjects published to date, an important expansion of OGM's evidence base into a large new application area. Third, at the 2026 European Society of Human Genetics Conference, or ESHG, studies featuring OGM increased 67% year over year, with authorship spanning 17 countries, up from 12 in 2025. a strong signal of the global breadth of the OGM research community. These studies join landmark multiple myeloma studies from John Hopkins and MD Anderson published in the American Journal of Hematology, which we highlighted last quarter and which demonstrated that OGM can significantly outperform traditional methods for detecting structural variations and chromosomal abnormalities. Taken together, we believe this expanding, increasingly clinical body of evidence is a leading indicator of future adoption and utilization of OGM. Regarding our fourth pillar, we're pleased to report progress on our goal to reach profitability. From a high 20% gross margin profile in 2023, we've steadily driven that figure higher over the past several years, reaching 53% in Q2, 2026, our highest quarterly gross margin to date. We have reduced operating expenses with the same disciplined philosophy. As revenue scales and our mix continues to tilt towards higher margin consumables and software, we expect these trends to carry us towards adjusted EBITDA breakeven over time, a key milestone we're focused on as we build towards sustainable profitability. Additionally, I'm happy to share that in the second quarter, we fully retired our outstanding senior secured convertible debt, further simplifying our financial profile. I'll now turn the call over to Mark Adamchak, our principal accounting officer, to review our Q2 2026 financial highlights and discuss our expectations for Q3 and the full year 2026. Mark? Thanks, Al.

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