Bionano Genomics, Inc.

Good day and welcome to the BioNano fourth quarter and full year 2025 earnings conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Webb Campbell from Gilmanton Group. Please go ahead.

Thank you, Carmen, and good afternoon, everyone. Welcome to BioNano's fourth quarter and full year 2025 financial results conference call. On the call today is Dr. Eric Homlin, CEO and Principal Financial Officer of BioNano, and Mark Adamczyk, 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 fourth quarter and full year 2025. A copy of the press release can be found on the investor relations page of the company's websites. 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 on information available to BioNano today, March 23, 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 in 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's website. With that, I will turn the call over to Eric.

Thank you, Webb, and good afternoon, everyone. I'm excited to share our fourth quarter and full year 2025 results with you today, as well as to provide you with our expectations for 2026. I want to begin, however, with the context of the broader space we're aiming to impact, namely pathology, which is the discipline that investigates the causes, developments, and effects of disease. Our products and solutions are focused on transforming pathology from tedious, slow, costly, and labor-intense analog workflows of the past towards streamlined workflows of a digital future defined by technology and platform consolidation, automation, and powerful AI-driven software. Our work in 2025, including the hundreds of publications and presentations by our users, demonstrated meaningful progress toward this goal and the significant value represented by this opportunity. As part of today's call, I want to take time to review the strategy we began implementing in September of 2024, our progress in 2025, and summarize key takeaways from a deep dive into our customer base, revealing the composition of our most profitable customer profile. First, however, I want to ask Mark Adamczak our principal accounting officer, to review our Q4 and 2025 financial highlights. Mark?

Thanks, Eric. Revenue for the fourth quarter of 2025 was $8 million, which is down 3% from $8.2 million in Q4 2024, but at the high end of our preannounced range of $7.8 to $8 million. We sold 7,554 nano-channel array flow cells in Q4, which was down 6% year-over-year, But it's worth noting that late in Q4, our manufacturing partner that makes the silicon wafers for our chip consumables experienced delays. As a result, supply was constrained against higher consumable demand. We entered 2026 with a healthy backlog of consumables demand and that we expect to realize in the coming quarters as these constraints ease. For the full year, 2025 revenue was $28.5 million. down 7% from $30.8 million in 2024. After adjusting for $1.7 million in discontinued clinical services in 2024, core revenue was down 2%. We sold 30,171 flow cells in 2025, down just 0.4% year over year. We also installed nine OGM systems in Q4 and 32 for full year 2025. exceeding our original guidance of 15 to 20 installations in the year. Turning to profitability, non-GAAP gross margin for the fourth quarter of 2025 was 43%, up from 42% a year ago. For the full year, non-GAAP gross margin was 47%, up from 35% in the full year 2024, an improvement of 1,200 basis points year over year, despite lower revenue. This reflects the efficiencies we are driving in our business under our new strategy. Fourth quarter 2025 non-GAAP operating expense was $9.7 million, down 9% year over year. For the full year, non-GAAP operating expense was $36.6 million, down 47% from $68.9 million in 2024. Importantly, since Q2 2023, We have removed approximately $100 million of annualized non-GAAP operating expense and reduced headcount by over 300 people. The transformation of our cost structure is clearly evident in these results. We ended the year with $29.6 million in cash, cash equivalent, and available for sale securities, including $10.3 million subject to certain restrictions. Based on factors described in our 10-K, we expect our cash runway to extend into 2027. I'd also note that our senior secured convertible debt is expected to be fully retired in May 2026, which will mark a meaningful balance sheet milestone that will further simplify our financial profile. With that, I'll turn it back over to Eric to review our strategic progress and achievements in 2025 and finish by providing financial guidance for 2026. Eric?

Thanks, Mark. That was an excellent job on your first time participating in one of our calls here. It's great to have you. In response to the challenging backdrop for tools and diagnostic companies that has persisted for some time now, we made a strategic shift that started in September of 2024 and entailed going away from aggressively expanding our installed base toward focusing on profitable growth from high volume users and selective customer acquisition. We established four strategic pillars to anchor this execution. First is to support and sustain the installed base of routine OGM and VIA software users. Second, to increase the utilization of optical genome mapping by these routine users by supporting menu expansion and improving ease of use with VIA software and our ionic system, which automates isolation of nucleic acids. Third is to build the support needed for optical genome mapping reimbursement and inclusion into medical society guidelines and recommendations. And fourth is to improve profitability and scalability through lower costs, higher volumes, and continuous improvement in product quality. Starting with this first and second pillars, tied to enabling our customers to use products more which will in turn result in higher consumable sales. While fourth quarter flow sales were down 7% at 7,554 and full year flow sales sold were essentially flat at 30,171, 2025 was certainly a transitional year where we faced uncertainty as to how stable the customer base would be during this strategic shift. We're pleased to see stability and consistency in the number of consumables that were purchased. If we remove flow sales tied to sales of new OGM systems in both periods, existing sales of flow sales to customers declined 4% in the fourth quarter, but grew 5% for the full year. Keep in mind that the consumable supply was constrained in the fourth quarter which muted some of that growth. Taken together consumables and software revenue decreased by one percent to 4.8 million in Q4 driven by a 22 percent decline in software revenue and that actually offset eight percent growth in consumables. The year-over-year decline in software revenue is a result of a handful of orders that were actually pulled forward into prior quarters. And so if we look and see that software grew 7% for the full year from 19, consumables and software together, that is, grew for the full year from 19 million to 20.4 million, which represents 7% growth, and as the share of total revenue increased from 62% in 2024 to 71% in 2025. And we believe this emphasis on consumables and software is a healthier, more predictable revenue profile that is also more profitable. Now, I want to talk a little bit about the composition of our install base. And this is something that we brought up on calls over the course of 2025. And I want to focus in on the customer profile that we've identified as the target for future growth. Throughout 2025, we focused on a subset of customers, so-called routine use customers. Those are customers who we believe have the greatest potential to purchase higher average volumes of OGM consumables. We also maintain a high level of support for our ionic system users and our via software users who use via software for non-OGM applications. Now, our geographic focus has also narrowed to include the United States. Canada, most of Western Europe, and Israel, although we have the help of excellent commercial partners who sell and support OGM outside of these regions. Now, looking across the 321 customers that have a total of 387 OGM systems installed as of December 31, 2025, routine use customers comprise about 130 or 40% of them. and they collectively operate about 175 systems or 45% of the global installed base. Routine use customers, by definition, have well-defined applications for OGM and a steady flow of samples coming into the lab for analysis and tend to have institutionalized funding for OGM, meaning they are not solely dependent upon raising grant funding for each individual project although grants do support these sites. Despite accounting for less than half of OGM, total OGM customers, these routine users actually drive the consumables business. In 2025, they accounted for about 83% of OGM consumables revenue. The average revenue per routine use customer in 2025 was about $89,000 or double the average per customer across the entire global installed base. Currently, there are about 60 routine use customers that have validated their OGM protocol. And in 2025, those customers accounted for about 56% of total consumables revenue And 69% of the consumables revenue coming from routine users, their average consumables revenue per year is $131,000 per customer. We also believe that there are about 55 routine use customers who intend to validate an OGM protocol in the future and about 15 who use OGM routinely but do not intend to. to validate. Going forward, we see the number of routine use customers increasing as new customer acquisition will focus on this customer type almost exclusively. We also see average consumable revenue per routine use site increasing as they expand their menus to include new applications and as others validate their protocols and begin offering their products commercially. Regarding our second pillar, we can help routine use customers in a variety of ways by including techniques and tools that enhance their ease of use with products like VIA software and our ionic system for automated nucleic acid isolation. In 2025, we made great progress to integrate VIA into customer workflows. and upgrade our software and compute platforms to make analysis of OGM, microarray, and next-generation sequencing data faster, easier, and more accurate. On this front, in 2025, we commenced a broad commercial release of our software and compute upgrades in the fourth quarter. VS 7.2 extends the AI-driven OGM workflow from hematologic malignancies into constitutional genetic disorders, giving labs the same automated curation and report capabilities that have accelerated heme malignancy workflows. SOLVE 3.8.3 expands the structural variation control database and improves detection accuracy, while the Stratus compute upgrade using advanced GPUs doubles weekly cancer sample throughput without any hardware change. VIA's reach extends beyond OGM. It's the gold standard for copy number variation analysis in microarrays and is gaining traction with next generation sequencing and even long read sequencing users. These non-OGM VIA customers represent a meaningful software revenue stream and a natural on-ramp to broader BioNano adoption at these customer sites. Now, the ionic system continues to expand, delivering high purity DNA and RNA for both NGS workflows and, of course, high purity, ultra high molecular weight DNA for OGM workflows at scale. Now, to build support for reimbursement and guideline recommendations, we're pleased to see incredible traction across the OGM community with publications that can support reimbursement decisions, professional society guidelines, and new customer adoption. The fourth quarter of 2025 was a record quarter for OGM publications, 136 new peer-reviewed publications, up from 25% year over year, up 25% year over year. 2025 also saw approximately 450 publications in total, up from 359 in 2024. And the total number of publications exhibits a compound annual growth rate of about 28% since 2020. In addition, the community has published roughly 1,190 human clinical research genomes in the fourth quarter of 2025 alone. which brings the cumulative total to nearly 12,700, up from fewer than 500 in 2021, and 4,500 added in 2025 alone. And that growth reflects a compound annual growth rate of about 30% since 2021. We believe these publications are an excellent leading indicator for the growing acceptance and future adoption and utilization of bio-nano products and solutions. Now, thanks to all of this progress, reimbursement improved significantly in 2025 with the establishment of a second Category 1 CPT code for OGM, this one covering OGM use in constitutional genetic disorders. The final price determination was $1,263.53, and that appears on the 2026 clinical lab fee schedule. In addition, the 2026 CLFS reflects a 47% increase in the payment determination for the Category 1 CPT code used for OGM in hematologic malignancies. That's now priced at $1,853.22, which is up from $1,263.53. Taken together, these two codes cover OGM's current primary application areas and represent key infrastructure that's now in place. OGM consortia from all over the globe coming together, these regional user groups help with things like access to reimbursement, influencing local guidelines, which together facilitate menu expansion and overall support the entire community of OGM users along their journey. We believe this validation This is validation that OGM is really taking off, and we are gaining this critical mass that is so important, where the community is becoming the advocate versus the company, which has historically been the case. Regarding our final strategic pillar of improving profitability and scalability, we continue to make progress in 2025, highlighted by the non-GAAP gross margin expansion we mentioned earlier. Our non-GAAP gross margins have now expanded from 22% in the first quarter of 2023 to 43% in the fourth quarter of 2025. And while quarterly non-GAAP operating expenses fell from roughly $34 million to now under $10 million over that same period. Going forward, we expect margin expansion in line with revenue as volumes grow in mixed product mix shifts towards consumables, and this is going to help us manage toward important financial milestones such as EBITDA breakeven. Finally, I want to highlight the excellent efforts from our team to host BioNano Symposium 2026. This event is held in late February and this year we had over 1,250 registrants coming from 73 countries around the world. The content featured 35 outside speakers presenting 33 presentations and the community contributed 50 posters to our poster hall. The event itself lasted four days and among the many excellent presentations, four reflected key themes that suggest growth opportunities for OGM going forward. Dr. Agnès Dorignon from CHU-LIL described how the French Optical Genome Mapping Group, or FROG, is acting as a network in support of implementation of OGM across 29 French-speaking laboratories in France, Canada, Switzerland, and Belgium. Dr. Ying Zhu from Johns Hopkins University School of Medicine presented the largest OGM data set in sarcomas, revealing complex abnormalities and novel biomarkers in karyotypically normal cases. These sarcomas represent an expansion of sample type from the blood and bone marrow aspirates that are commonly used with OGM today. There were two speakers who spoke to an incredibly important theme in Symposium 2026, which is OGM at Scale. Dr. Alexander Hoysian from Radboud University Medical Center in the Netherlands described fully automating ultra-high molecular weight DNA isolation and labeling for OGM and their plans to ramp to processing 3,000 samples per year, up from just 500 in 2025. Radboud now has three Stratus systems and two Sapphire systems, making them the lab with the most OGM capacity in the world, aside from BioNanos, of course. And Dr. Adam Smith of LabCorp presented a rigorous comparison, showing that a scaled Stratus workflow can process up to 10,000 cancer samples per year versus approximately 240 for a similar high throughput long read sequencing platform. And the cost of OGM is less than one-eighth of the initial capital investment for processing 1,000 long read sequencing samples per year. We believe OGM is moving from early adoption into operation at scale. And academic networks like the Frog, academic medical centers like Johns Hopkins and Radboud University Medical Center, and national reference laboratory institutions like LabCorp are building the operational and use cases for it. All of this progress and support gives me confidence in a strong outlook for the full year 2026. Therefore, we are initiating revenue guidance of 30 to 33 million, representing growth of 5 to 16 percent over 2025. And for this first quarter of 2026, we are initiating revenue guidance of 6.5 to 6.7 million dollars, representing flat to 3 percent growth over 2025. As our Q1 expectations imply, we do expect revenues to grow throughout the year consistent with the seasonality common in our business as we continue executing on our mission to increase the use of our differentiated capabilities among our valued customers. We're very excited about this work and the journey ahead of us at BioNano. And so with that, I would like to open the line now for questions. Carmen?

Thank you so much, and as a reminder, If you do have a question, simply press star 11 on your telephone and wait for your name to be announced. To remove yourself, press star 11 again. Again, if you do have questions, press star 11 to get in the queue. We have a question from the line of Yi Chen with . Please go ahead.

Thank you for taking my question. Could you give us any color on what your expectations regarding how many new OGM systems could be installed during 2046? Yeah.

Hi, Yi. Thank you for joining and, you know, asking an important question. think that we have expectations which are comparable to what we shipped last year. We're not really providing any guidance on the number because, as you can see, we significantly actually overperformed guidance last year. And so we want to just stay flexible about the new systems that are being installed. But it's reasonable. that we would have a comparable year this year to what we did last year.

Got it. And also, the reported number of nanochannels array flow cells sold in 2025 is slightly below the number in 2024 while using storage. 32 new OGM systems and brought back 16 during the year. So how should we look at the nano, I mean, how should we expect the number of nanochannel energy flow cells to be sold this year? Do you expect that to be relatively flat as well?

Yeah, I mean, so no, the answer is no. I would say that, you know, when you look at the revenue growth that we're forecasting, that revenue growth is going to be driven by new systems, of course, and consumables at existing customers. And so I think I would expect the consumables volume range to likely track with the revenue growth, which is a wide range. But that's our expectation. And we were flat year over year on total consumables volume. When we look at what routine users did, we do see that routine users grew 2025 over 2024. And keep in mind that we were constrained with supply at the end of the year, it's nothing that's particularly concerning. It's a supply constraint that will, I think, work its way out over the course of the next couple of quarters. But if we weren't up against that supply constraint, we would have had additional units growth.

Okay. Okay. And the guidance for 2026, you provided $30 to $33 million, which translates to approximately 5% to 16% top-line growth. Do you need to – I mean, how many nano-channel or new LGM systems you need to sell to achieve that level of growth? Is that – Is there any catalyst that you expect to occur in 2026 in order to achieve that level of top line growth?

Yeah, I mean, I think that so, you know, again, we're not going to, you know, put a number out there of systems. And I think, you know, really the reason is that we want to keep the focus on the productivity of the routine users. And, you know, we'll be updating on some of the dynamics of that group over the year, right? So if you look at total number of customers at the end of the year, 321, total systems installed, 387, 32 systems shipped in the year. It's really about these 130 or so routine use customers, 60 of which have validated an OGM protocol and roughly 55 are intending to do that at some point in the future. So how can we take that 55 and, you know, convert them over to the validated group? And then how can we expand revenues amongst the validated group? But, you know, that's where we expect the growth to come from. And, you know, as long as we kind of repeat on a year-over-year basis some of the same dynamics, we'll hit these numbers. From a catalyst perspective, a big catalyst is the increase in the price determination for the uh hematologic malignancy cpt code eight one one nine five um forty seven percent increase you know twelve hundred dollars to you know eighteen hundred dollars you know that that is a big driver so that becomes a became effective january 1st 2026 and so you know we we we have seen the positive effects just of the originally priced code, and we expect this higher price to even accelerate adoption and utilization more. That's a major catalyst.

Okay, good.

Thank you. Thank you, and this concludes our Q&A session. I will pass it back to Eric for final comments.

Okay, thank you, Carmen, and thank you, everybody, for joining. We look forward to updating folks on our progress in the first quarter of 2026 in the not-too-distant future. Thank you very much.

Thank you for participating and you may now disconnect.