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DATE
Tuesday, Nov. 10, 2026
CALL PARTICIPANTS
- Chairman and Interim CEO - Al Luderer
- Chief Accounting Officer - Mark Adamchak
- Investor Relations - Webb Campbell
TAKEAWAYS
- Total Revenue -- $8.3 million, representing an increase of 12% compared to the prior year period.
- Consumables Revenue -- $4.7 million, growing 24% year over year driven by sales to existing customers in the Americas.
- Flow Cells Sold -- 9,870 units, an 18% increase versus the same period last year and a record for any quarter.
- Software Revenue -- $1.1 million, a 31% decrease year over year reflecting a lower number of VIA software licenses sold.
- Other Revenue -- $2.5 million, up 24% year over year led by higher instrument sales to new customers.
- EMEA Revenue -- $4.1 million, representing 14% growth year over year primarily due to increased instrument sales.
- Americas Revenue -- $3.8 million, an increase of 35% compared to the third quarter of 2025.
- Adjusted Gross Margin -- 48%, an improvement from 46% in the same quarter last year.
- Operating Expenses -- $10.5 million, a 12% reduction year over year as the company manages its cost structure.
- Adjusted Operating Expenses -- $8.8 million, representing a 9% decrease year over year.
- Cash and Equivalents -- $8.7 million, including cash, equivalents, and available-for-sale securities as of Sept. 30, 2026.
- Full Year 2026 Revenue Guidance -- $31 million to $33 million, representing expected growth of 9% to 16% over 2025.
- 2027 Revenue Target -- $50 million to $54 million, as outlined in management's long-term strategic operating plan.
- EBITDA Target -- Adjusted EBITDA neutrality, which management expects to reach by the end of 2027.
- Medicare Jurisdiction Reach -- 31 U.S. states, representing the population covered by the MolDX jurisdictions that proposed a local coverage determination for the technology.
- Clinical Publication Volume -- 365 studies, published year-to-date demonstrating the clinical value of optical genome mapping.
- MDS Genomic Identification -- 15.9% of cases, in which optical genome mapping identified chromoanagenesis in a study of 332 subjects with myelodysplastic syndromes.
- Patient Survival Variance -- 9.9 months, representing the median survival for MDS subjects with detected chromoanagenesis versus a significantly higher median for the rest of the study group.
- AML Diagnostic Yield -- 46% of cases, where structural variants were detected in samples previously classified as normal by conventional karyotyping.
- Academic Adoption -- Two leading academic centers, in New York brought the technology into clinical laboratories following state approval.
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RISKS
- Luderer stated, "supply constraints in our production... has really kept us from meeting a very strong customer demand this year," regarding back orders caused by long lead times for silicon wafers.
SUMMARY
Bionano Genomics, Inc. (NASDAQ:BNGO) reported financial performance for the third quarter of 2026, highlighting a strategic transition toward profitable growth through the routine clinical adoption of optical genome mapping. Management stated that the company is prioritizing high-volume users and menu expansion to drive recurring consumable revenue. The company is working toward achieving adjusted EBITDA neutrality by the end of 2027, supported by cost discipline and planned improvements in supply chain capacity. Developments in reimbursement, including a proposed Medicare coverage determination and new Category 1 CPT codes, were identified as primary drivers for future market penetration.
- Luderer highlighted the significance of regulatory progress, stating, "For laboratories, a clear coverage pathway lowers the financial risk of validating OGM and moving it into routine use."
- Regarding supply chain challenges, Luderer noted that the company has taken effort to "double our capacity that we have today" by midyear 2027 to address instrument back orders.
- Adamchak noted that production constraints are expected to ease by the end of the year, stating, "As we reach the end of the year, we expect these constraints to ease."
- Management described the VIA software as a strategic "on-ramp to broader OGM platform adoption" for laboratories currently using microarrays or next-generation sequencing.
- Luderer stated that the strategy adopted in Sept. 2024 has "positioned ourselves to be a more focused, agile and sustainable company" by focusing on routine, high-volume users.
- Management confirmed that Memorial Sloan Kettering Cancer Center launched hematologic malignancy testing using the company's technology following state approval.
INDUSTRY GLOSSARY
- OGM: Optical Genome Mapping, a technique for identifying structural variations in the genome through high-resolution imaging.
- LCD: Local Coverage Determination, a decision by a Medicare Administrative Contractor regarding whether a specific service is covered in their jurisdiction.
- MolDX: Molecular Diagnostic Services Program, which evaluates molecular diagnostic tests to establish Medicare coverage and reimbursement.
- VIA: A software system for the analysis and interpretation of genomic variants from multiple platforms.
- Ionic: A system used for the extraction and purification of high-purity DNA and RNA using isotachophoresis technology.
- Structural Variation: Genomic alterations such as deletions, duplications, or rearrangements affecting large segments of DNA.
- Saphyr: The company's platform system for performing optical genome mapping.
- Chromoanagenesis: A catastrophic single event leading to massive genomic restructuring within a cell.
- Flow Cell: A disposable component equipped with nanochannel arrays used for DNA linearization and imaging.
Full Conference Call Transcript
Operator: Good day, and thank you for standing by. Welcome to Bionano Third Quarter 2026 Financial Results Conference Call. [Operator Instructions]. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Webb Campbell, Investor Relations. Please go ahead.
Webb Campbell: Thank you, Stephanie, and good afternoon, everyone. 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.
Albert Luderer: 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 at 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 4 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 installed 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 is 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 VA without OGM give us a base of software revenue, and this is often the first step towards using more of our platform.
Ionic, 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 MolDX's proposed local coverage determination or LCD for OGM. In late August, MolDX published a proposed LCD that would set Medicare coverage in the Medicare administrator contractor jurisdictions that follow MolDX, 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. MolDX states also represent roughly 61% of the U.S. 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 2 Category 1 CPT codes for OGM, one in hematologic malignancies and another for constitutional genetic disorders. Additionally, CMS has established reimbursement rates for both codes. The coverage determination from MolDX 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 2 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 3 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 chromoanagenesis, 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 Josep 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 8 where conventional banding failed and identified 134 additional genomic alterations. OGM defined genomic groups showed significant differences in overall survival with chromoanagenesis 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 towards 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: 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 and 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 in Q3 2025. We ended the quarter with $8.7 million in cash, cash equivalents and available-for-sale securities, including $0.5 million subject to certain restrictions. Turning to guidance.
For the full year 2026, we are reiterating our revenue guidance of $31 million 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?
Operator: [Operator Instructions]. Our first question comes from Yi Chen of H.C. Wainwright.
Unknown Analyst: This is [indiscernible] for Yi. Looking at the September framework of $50 million to $54 million in 2027 revenue and approximately breakeven 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 what are supported by customer implementation schedules versus like milestones still ahead?
Albert Luderer: Yes. Thanks for the question. 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 controlled 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 want 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.
Unknown Analyst: If I could follow on real quick. For the supply constraints, can you elaborate a little bit more on what remains to meet that time line once the backlog is cleared, will current capacity support the flow cells for your 2027 plan?
Albert Luderer: Yes. Yes, there's a long lead time for some of our most critical components and notably the silicon wafer that has all the nano channels. 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 midyear 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.
Operator: Our next question is from Michael Okunewitch from Maxim Group.
Michael Okunewitch: 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 that you're facing.
Albert Luderer: 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 MolDX 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 Okunewitch: Appreciate that. And then also I wanted to congratulate you on the news with Sloan, a 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?
Albert Luderer: 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 time, 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 will take very long.
Michael Okunewitch: And one last one for me before I hop into the queue. I want 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.
Albert Luderer: Well, our Bionano lab is -- it really exists to help us understand how our customers are experiencing our products. And 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. So it's really -- 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 Okunewitch: All right. I appreciate your additional clarity and once again, congrats on all the progress.
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.
Albert Luderer: Thanks, Steph.
Operator: Thank you.
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