BNGO Bionano Genomics, Inc.

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Bionano Genomics, Inc. Q3 F2026 Earnings Call Transcript

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Stephanie
Conference Call Operator
Good day, and thank you for standing by. Welcome to BioNano Third Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference call is being recorded. I would now like to hand Thank you, Stephanie, and good afternoon, everyone.
Webb
Investor Relations
Welcome to Bionano's third quarter 2026 Financial Results Conference Call. On the call with me today are Al Luderer, Chairman and Interim CEO of Bionano, and Mark Adamchak, Bionano's Chief Accounting Officer. After market closed today, Bionano issued a press release announcing its financial results for the third quarter 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 risk factors and risks, some of which are identified in BioNano's press release and BioNano's reports filed with the SEC. These forward-looking statements are based on information available to BioNano today, November 10, 2026, and the company assumes no obligation to update statements as circumstances change. During our call, we may refer to certain non-GAAP financial measures, which we believe provide useful information for investors. Reconciliations of these measures to GAAP can be found in our press release and slide deck. An audio recording and webcast replay for 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.
Al Luderer
Chairman and Interim CEO, Bionano
Thank you, Webb, and good afternoon, everyone. I'm pleased to be here with you all today to share our third quarter 2026 results. BioNano delivered a strong third quarter. Our results reflect the trust our routine use customer base places on our products and the continued global utilization of optical genome mapping, or OGM, for discovering and analyzing diseases. Over the quarter, we saw momentum build across our business as well as the broader genomics community. Clinical adoption is what drives our results, and we saw progress on several fronts that make it easier for customers to bring OGM into routine practice. We expect that adoption, along with greater use of both existing and new clinical sites, to remain the foundation of our growth moving forward. We continue to pursue our mission of transforming pathology, The field devoted to understanding the causes, progression, and impact of disease. Traditional methods for structural variant detection are costly, repetitive, labor-intensive, and time-consuming. By helping customers move to digital workflows supported by our consolidated platforms, automation, and decision intelligence software, we can provide a faster, more efficient, and more informative way to analyze the genome. Today I'll walk through how we have been advancing toward that goal across our four strategic pillars. I'd like to take a moment to revisit the framework that guides how we execute. In September 2024, we made a deliberate shift away from aggressive installed base growth towards profitable growth with our existing routine users. By placing an emphasis on prospects most likely to become routine, high volume users, we've positioned ourselves to be a more focused, Agile, and Sustainable Company. In practice, this is done through the following. 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. So turning to our first and second pillars, which are focused on supporting our install base and driving greater utilization of our products. Q3 2026 flow cells sold were up 18% year over year at 9,870 units, a record for any quarter. In short, our customers are processing more samples than ever, and a large share of that added volume comes from laboratories bringing OGM into routine use. Now, breaking down our revenue segments, consumable revenue was 4.7 million in Q3 2026, up 24% year over year, driven by sales to existing customers in the Americas. Software revenue was $1.1 million in Q3 2026, down 31% year over year, reflecting a lower number of via software licenses sold in the period. Other revenue, which includes instruments and services, was $2.5 million in Q3 2026, up 24% year over year, led by higher instrument sales to new customers. The continued move towards more recurring, consumable-driven revenue gives us a healthier and more predictable business, and it's evidence of our strategy in action. I'd also like to highlight the geographic profile of our quarter. Revenues in Europe, the Middle East, and Africa grew 14% year-over-year to $4.1 million, up from $3.6 million a year ago, driven by growth in instrument revenue. Revenue in the Americas grew 35% year-over-year to $3.8 million, Adoption of OGM is not happening in a vacuum. Its value is being recognized globally as the investments we have made in evidence generation begin to translate to adoption. Regarding our second pillar, increasing OGM utilization by supporting software adoption and menu expansion, customers continue to give us very positive feedback on our software and compute upgrades that let them broaden their test menus and run more samples and in some cases have allowed them to double weekly cancer sample throughput with no change to their hardware. Our VIA software remains the gold standard for CNV analysis on microarrays and we continue to see adoption among NGS and long read sequencing labs. Customers who use VIA without OGM give us a base of software revenue and this is often the first step towards using more of our platform. Our system for producing high purity DNA and RNA also remains a key focus, supporting both OGM and NGS workflows at scale. We are increasingly seeing our software offerings as an on-ramp to broader OGM platform adoption. As we begin to see the transition of array via customers to OGM, we will eventually recognize some decline in software revenue, but expect to offset this loss by bringing these customers deeper into our OGM ecosystem. As we focus our resources on the largest opportunities in clinical OGM, we view the migration of these customers to OGM as a critical step forward for more routine use. Now, highlighting our third pillar, building support for OGM reimbursement and inclusion in medical society guidelines, an important development this quarter was Moldex's proposed local coverage determination, or LCD, for OGM. In late August, MALDEX published a proposed LCD that would set Medicare coverage in the Medicare administrator contractor jurisdictions that follow MALDEX, representing 31 U.S. states. This coverage determination establishes a criteria for OGM-based genome-wide detection of copy number alterations and structural variants in hematologic neoplasms. The public comment period has now closed, and we look forward to the final determination. Today, Medicare is the largest payer for cancer care, and about 60% of new cancer diagnoses are in Medicare-eligible patients. MALDC states also represent roughly 61% of the US population, and private insurers often write their policies in line with Medicare coverage. For laboratories, a clear coverage pathway lowers the financial risk of validating OGM and moving it into routine use, further supporting the broader adoption and utilization that drives demand for our products. This builds on the reimbursement foundation we described last quarter. As we previously noted, the AMA has approved two Category 1 CPT codes for OGF, one in hematologic malignancies and another for constitutional genetic disorders. Additionally, CMS has established reimbursement rates for both codes. The coverage determination from MALDEX would add a clear path to Medicare coverage for OGM and hematologic malignancies. Together, we believe these developments are creating meaningful momentum for OGM and make it easier for customers to become routine users. Another milestone this quarter came in New York, where two leading academic centers are now bringing OGM into their clinical laboratories. The New York State Department of Health approved OGM-based laboratory-developed tests at University of Rochester Medicine covering genetic disorders, reproductive disorders, and hematologic malignancies. Memorial Sloan Kettering Cancer Center then launched OGM-based hematologic malignancy testing following state approval. State approval is a significant step allowing institutions to offer OGM testing in New York. As more leading cancer centers adopt OGM in their clinical workflows, Our base of routine users expands, subsequently driving utilization of our products. Now, expanding on our third pillar, the growing body of evidence continued this quarter with three new independent peer-reviewed publications showing the potential clinical value of OGM in high-risk myeloid cancers. The first, published in Modern Pathology by researchers at MD Anderson, used OGM to study 332 samples from subjects with myelodysplastic syndromes, or MDS. OGM identified chromoantigenesis, a catastrophic single event genomic restructuring process, in 15.9% of cases overall and 17.6% of newly diagnosed subjects. These subjects had a median survival of 9.9 months, while the median survival for the rest of this group was much higher as it had not been reached during the study. Researchers noted that this information could help doctors identify high-risk patients earlier and consider more aggressive treatments. The second study published in the International Journal of Cancer by the University of Oulu, Finland, analyzed 48 samples of cytogenetically normal acute myeloid leukemias. The study found that OGM detected clinically relevant structural variants in 46% of cases classified as normal by conventional karyotyping. and the presence of OGM-detected abnormalities was associated with worse survival in these individuals. The third study published in NPJ Precision Oncology by the Joseph Carreras Leukemia Research Institute in Spain studied subjects with therapy-related myeloid neoplasms and younger onset MDS. It found that OGM produced a result in every sample, including all eight where conventional banding failed, and identified 134 additional genomic alterations. OGM-defined genomic groups showed significant differences in overall survival with chromoantigenesis emerging as the strongest independent predictor of inferior overall survival. These publications join the T-cell acute lymphoblastic leukemia study we highlighted last quarter, also published in Modern Pathology and conducted by researchers at MD Anderson and Johns Hopkins. Together, these publications, along with the 365 studies published year to date, give us confidence that the expanding body of clinical evidence is a leading indicator of future adoption and utilization of OGM. Turning to our fourth pillar, we continue to make progress on profitability. In 2023, our adjusted gross margin was in the low 20% range. Since then, we've steadily improved it, and in the third quarter, we generated a gross margin of 48%. compared with 46% in the same quarter last year. We've applied the same discipline to our cost structure. Operating expenses decreased 12% year over year to 10.5 million and adjusted operating expenses decreased 9% to 8.8 million. As revenue grows and our mix shifts towards higher margin consumables and software, we expect these trends to carry us toward an adjusted EBITDA neutrality by the end of 2027. So I'll turn the call over right now to Mark Adamchak, our Chief Accounting Officer, to review our Q3 2026 financial highlights and discuss our expectations for Q4 and the full year of 2026. Mark?
Mark Adamchak
Chief Accounting Officer, Bionano
Thanks, Al. Revenue for the third quarter of 2026 was $8.3 million, up 12% compared to Q3 2025. We sold 9,870 nanochannel array flow cells up 18% compared to Q3 2025. We've been continuously investing in production throughput, and as we reach the end of the year, we expect these constraints to ease. Turning to profitability, adjusted gross margin for the third quarter of 2026 was 48% compared to 46% in Q3 2025. Third quarter 2026 adjusted operating expense was 8.8 million compared to 9.7 million and Q3 2025. We ended the quarter with $8.7 million in cash, cash equivalents and available for sale securities, including a half million subject to certain restrictions. Turning to guidance, for the full year 2026, we are reiterating our revenue guidance of $31 to $33 million, representing growth of 9% to 16% over 2025. Within that range, we expect to land near the midpoint. We are encouraged by the momentum across our business and excited for the path ahead of BioNano. With that, I will turn the call back to the operator. Stephanie?
Stephanie
Conference Call Operator
Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Yi Chen of HC Wainwright. Your line is now open.
Kitty
Analyst, HC Wainwright
This is Kitty on for Yi. Looking at the September framework of 50 to 54 million in 2027 revenue and approximately breaking even adjusted EBITDA exiting Q4, does that remain in your operating plan? What are the largest contributions to that acceleration from The current run rate and which are supported by customer implementation schedules versus like milestones still ahead?
Al Luderer
Chairman and Interim CEO, Bionano
Yeah, thanks for the questions. So our main focus for 27 is going to be to bring this company to EBITDA neutral so that we can move into 2028 in a highly profitable mode. That is our main focus. Driving that is going to be our control of expenses and also very rapid top line growth. So in September, when I spoke at the Wainwright Conference, I presented a vision of what we might be in the future. And I wanted this to be a guideline for where this company and its underlying technology can be and what it can do as it transforms medicine. So there are some large customers that are starting to come online for us, and they will be part of the majority of our growth, as well as some of the supply constraints that Mark had mentioned in our production, which has really kept us from meeting a very strong customer demand this year.
Kitty
Analyst, HC Wainwright
If I could follow on real quick. For the supply constraints, can you elaborate a little bit more of what remains to meet that timeline once the backlog is cleared? Will current capacity support the flow cells for your 2027 plan?
Al Luderer
Chairman and Interim CEO, Bionano
Yeah, there's a long lead time for some of our most critical components, notably the silicon wafer that has all the nanochannels. So yes, we've taken special effort to build up that supply and be able to essentially double our capacity that we have today. And we'll do that about halfway through mid-year next year. that will more than meet the capacity for 27 that we're projecting and also most of 28. So we think we have that in good shape and we think we'll be essentially free and clear of any back orders by the end of this year. That's our plan right now.
Stephanie
Conference Call Operator
Perfect. Thank you.
Al Luderer
Chairman and Interim CEO, Bionano
Pleasure. Thank you.
Stephanie
Conference Call Operator
Thank you. Our next question is from Michael Okunwich from Maxim Group. Your line is now open.
Michael Okunewich
Analyst, Maxim Group
Hey, guys. Thank you so much for taking my question, and congrats on the progress. You posted some quite strong growth in terms of the flow cell utilization, so I wanted to see if you could talk a little bit about what the main drivers are for that particular increase. and if that is at all tempered by some of those supply constraints you're facing.
Al Luderer
Chairman and Interim CEO, Bionano
Glad to expand on that, Michael, and thanks for the question. What we all believe right now is the, first of all, the very strong clinical evidence that's global in nature, backed up by the CPT coding and now MALDEX is favorable. Determination for Hematologic Oncology. We think that's a large driver of this. And we have several sites that have become major users, and we see some that are in queue to become also as large as some centers that we have. And I think it's mostly due to the fact they can offer the service and have a very good shot at getting paid for their services. So I think that's a huge part of it, Michael.
Michael Okunewich
Analyst, Maxim Group
Thank you, appreciate that. And then also I wanted to congratulate you on the news with Sloan, particularly exciting stuff. And I want to see if you could talk just a little bit about how Memorial Sloan Kettering plans to implement OGM through BioNano Labs. Is this a pilot program, or are they implementing it more broadly into their routine workflows?
Al Luderer
Chairman and Interim CEO, Bionano
That's a great question, and I'm really not prepared to answer that, but we can get back to you on that. So I think... They received authorization to offer the service back right around the Wainwright Conference times, early September. So as all these things, it takes a while to get going and then integrate into the clinical service and have the ordering physicians start to get used to and understand this new type of information that they are now privileged to see on these patients. So we've seen that adoption take a little bit of time, but at Sloan Kettering, I don't think it'll take very long.
Michael Okunewich
Analyst, Maxim Group
Thank you, and one last one from me before I hop into the queue. I wanted to see if you could just provide a bit more color on what the customer profile looks like for BioNano Labs versus actual internal adoption of OGM through a machine.
Al Luderer
Chairman and Interim CEO, Bionano
Well, our BioNano Lab is, it really exists to help us understand how our customers are experiencing our products. While we do offer a commercial offering in the muscular dystrophy, we currently don't have any hematologic product, but that is part of our forward planning process that we're considering. That laboratory functions really as an in-house experience so that we can have real-time experiences that our customers have, which we can't always get.
Michael Okunewich
Analyst, Maxim Group
All right, thank you. I appreciate your additional clarity, and once again, congrats on all the progress. Thanks again, Michael.
Stephanie
Conference Call Operator
Thank you. This does conclude the question and answer session for today. We thank you for your participation in today's conference, and this does conclude the program. You may now disconnect.
Al Luderer
Chairman and Interim CEO, Bionano
Thanks, Steph.
Stephanie
Conference Call Operator
Thank you.