Bionano Genomics, Inc. (BNGO) Earnings Call Transcript & Summary

Welcome to the H.C. Wainwright 27th Annual Global Investment Conference. I'm Katherine Degen, an associate biotech research analyst at the firm. I'd like to take a moment to welcome Erik Holmlin from Bionano and take it away.

Thank you, Katie. I want to certainly thank everybody at Wainwright for the opportunity to participate here today. This is always a great conference. And we really began a pretty significant transformation of Bionano about a year ago, and I'm happy to report on the progress that we've been making. But before I delve into that, I want to take some time to point out that we're a publicly traded company, and I want to refer everybody to our filings on the SEC website. and certainly take a moment to step back from the sort of day-to-day and quarterly -- quarter-to-quarter operations of Bionano and think about the space that we're operating in. And when we do that, we see the analog world of pathology. If you look across pathology and patient sample testing, both for diagnostic applications and for cutting-edge research, it's really an array of multiple techniques that have been in operation in many cases for upwards of 50 years. Just take karyotyping as an example. It's a global standard used around the world, a lot in cancer and in genetic diseases, and yet it hasn't changed much in that period of time. In fact, there are millions and millions of samples that process through these workflows causing a labor-intense workflow that takes a lot of time to go from sample to result and creates a lot of confusion amongst the oncologists or physicians who are managing patients. And that's because it's an analog world. And we recognize at Bionano the opportunity to digitize the whole pathology process. Now we can't do that alone with our products. Our optical genome mapping is playing a big role in transforming cytogenetics, which is something that I'll talk a lot more about. But we also have our VIA software, which is an AI-driven platform that spans across the optical genome mapping world into sequencing. And we also have our Ionic system for nucleic acid isolation, which fits nicely into sequencing workflows. So we're playing a big role in the transformation of pathology to digital pathology, and that's why we think of ourselves as a digital pathology company. Now we pioneered optical genome mapping to be something that would really replace the legacy methods across cytogenetics. In fact, we believe we're serving an available market of about $10 billion. It comprises roughly 10,000 labs across the world, processing about 10 million cases per year. Right now, we're focused in key geographies like the United States, Canada, Western European countries and Israel, where optical genome mapping has a really strong foothold. And when we look at the value proposition of optical genome mapping against some of the more traditional methods that are out there, in fact, the global standards like karyotyping, FISH and microarrays, we can see on the one hand, those workflows are outdated, they're antiquated, very labor intense. And when you talk to laboratories that are offering those workflows, they'll tell you that the people who run karyotyping, for example, are retiring, and it's more of an art than a science. And so it's difficult to replace them. They're looking for digital methods that can do the same thing, but get better results. So if you look at the clinical utility of traditional cytogenetic methods, it's pretty limited. So only about half of karyotypes, for example, come back with useful information that can be used to guide therapy. In fact, in leukemias, 50% of the time, patients who know -- are known to have leukemia get a normal karyotype. And that really gives the oncologist nothing to work from to manage the patients. Studies have shown that as many as 20% of prognostic scores in myelodysplastic syndrome, for example, may be wrong. And so those are scores that are used to treat patients or make a decision between therapeutic intervention or something like a bone marrow transplant. And if that's wrong 1 out of 5 times, that's not good. So half of the time, you don't get a useful answer at all. And then of the 50% answers that are coming back, 1/5 of those are wrong. And so the clinical utility of these traditional workflows is severely limited. And this is the problem that we're attacking. Now optical genome mapping, on the other hand, is a faster and simpler workflow. It takes the place of 3 of these traditional methods. So you can imagine just from a technology workflow consolidation standpoint, optical genome mapping offers something that labs are looking for. They're constantly under pressure to reduce costs. workforce shortages are real things across these labs. And so optical genome mapping can replace 3 of these workflows with 1. It consistently finds more actionable variants. And so in an analysis, for example, compared to karyotyping, optical genome mapping will return useful information that researchers or physicians can use in their project much more commonly than the traditional methods. Importantly, recently, in June of 2024, the American Medical Association established a Category 1 CPT code to cover the use of optical genome mapping in hematologic malignancies. And then this year, in June of 2025, they established a second code. This one, the second code to cover constitutional genetic disorders. So our 2 main application areas are covered by Category 1 CPT codes, which is a very high bar to overcome. And then lastly, I want to point out that if you think about this whole space of transforming pathologic -- traditional pathologic -- pathology methods into a digital approach, you're going to think that sequencing is going to be there. And you may think, well, is optical genome mapping competing with sequencing? And the answer is they're not competing. In fact, they're highly complementary. And so labs run mapping and sequencing side by side, and that really improves the results that they're seeing. Now customers adopt what we call the end-to-end solution for optical genome mapping. And in this sense, it's a relatively traditional life sciences instrumentation model. So we have kits, kits for isolating nucleic acids, labeling it before it goes into the imaging chip and into the imaging instrument. We have also been in development of the Ionic system for optical genome mapping. It currently serves nucleic acid isolation markets from formal and fixed paraffin embedded tissues that's useful in advance of next-generation sequencing assays, for example, we're going to release that system for optical genome mapping sometime in 2026. Customers buy the instrument. We sell the Stratys instrument, which is pictured here as well as the Saphyr. Those are 2 models that customers can adopt depending on their throughput needs. And then we have a high-performance compute server. This is a server we developed in a collaboration with NVIDIA to incorporate their GPU chips into the server. And lastly, we have the VIA software. So VIA software is a critical component of the overall workflow, and it's really cutting edge compared to what any sequencing analysis platform or genome analysis platform company is selling. VIA, which stands for Variant Intelligence Applications, allows researchers to visualize, interpret, analyze, annotate and report their findings in an incredibly streamlined workflow that's highly automated. And so in the past, with traditional methods, laboratories would be delivering multiple reports to their end customers at multiple times across the analysis of the sample and VIA really streamlines that in conjunction with optical genome mapping. So there is a single report with all of the information that somebody might be looking for, for example, from WHO or NCCN guidelines in relation to that specific sample. And so the end-to-end workflow is what customers adopt. And as I point out on this slide, parts of it serve adjacent markets like the sequencing market, the Ionic system for nucleic acid isolation and VIA software is used for analysis, interpretation and reporting from chromosomal microarray analysis as well as NGS. And so we have a product portfolio serving this pathology digitization effort that is pretty broad. Now optical genome mapping works because it's resolution across the -- resolution sort of continuum of genome variation analysis covers an incredibly large area. So as you can see on this slide, optical genome mapping covers the resolution that has typically required 3 techniques, karyotyping, FISH and microarrays. Optical genome mapping can pick up all the variants that those pick up and provide a lot more information in many cases. As you can see, it also spans a coverage gap that historically no technique has been able to analyze, and that's why we believe that optical genome mapping consistently finds more information in samples because it's finding variants that are typically not detected. But importantly, there's very little overlap with sequencing, some with long-read sequencing, but it lines up nicely with short-read sequencing. So for a lab to get comprehensive analysis of genome variation across samples, they really only need to use mapping and sequencing, which is very powerful. And you can see that the VIA software fits in nicely for analysis of large variants and that can be from sequencing or mapping, it doesn't matter. And then the Ionic system marries up nicely with nucleic acid isolation from FFPE in advance of sequencing assays. So that's why optical genome mapping works. And when we think about the application areas that are specifically of interest to us in this cytogenetics market, the 3 of them are listed here. So hematological malignancies, leukemias, lymphomas, myelomas is where we have great support in the literature for the application of optical genome mapping as a faster system with higher success rates in detecting pathologic variants and a higher level of accuracy. Constitutional genetic diseases. So here, you should be thinking about intellectual disability, autism spectrum disorder, other forms of developmental delays that cause for analysis in a genetics lab, optical genome mapping can perform those. And now those 2 applications are covered by Category 1 CPT codes in the United States and reimbursement is in place in many countries throughout Europe, where we're active, other places such as Israel. And the Turkish Health Ministry just introduced optical genome mapping into its systems. And so physicians can order it as a clinical test there. The third area is in cell and gene therapy. So when you think about stem cell therapies or CAR-T therapies or other gene therapies, it's important to monitor the genome integrity of the samples that you're dealing with. That may be in the case of editing cells where you want to make sure that you don't have off-target effects or you want to confirm on-target delivery of the therapeutic payload. Optical genome mapping can play a role in that determination. And in stem cell therapy, where you're growing successive generations of cells, you want to make sure that the starting material looks like the final material. And so it's possible to verify that using optical genome mapping. And so these are the 3 areas that are driving adoption and utilization of optical genome mapping in our target geographies. As I mentioned a year ago, we really undertook a large transformation of the company to focus -- kind of take the focus away from aggressive growth of the installed base, which is, let's face it, not the most capital-efficient approach to proliferating our platform to something that's much more capital efficient and focuses on the existing users that we had developed at that time. We call them our routine use customers. These are customers who are buying consumables consistently on a periodic basis, repeatedly and generating useful results, publishing their results from optical genome mapping data. And these are the profitable customers. And so our strategy is focused on them. We want to, of course, support and sustain them. We want to drive their utilization up. So we have a number of training programs and our VIA software is something that really enhances their workflow and speeds it up. So it makes it possible for them to process more samples. And so we have teams that are dedicated to training labs and using VIA software and increasing their capacity, expecting them to then utilize more consumables. We're very focused on continuously building support needed for reimbursement of optical genome mapping as well as the eventual inclusion of OGM into medical society recommendations and other guidelines. And then lastly, we're focused on driving margins up, reducing costs and through higher volumes driven by sales and improving profitability. And so this is the strategy we've been executing on. You can see here is your quarterly top line revenues over an extended period of time. And you can look at this chart and you can feel the turbulence that the company has gone through. But I want to focus in really on the first and second quarter of 2025. These were solid quarters, well within our guided ranges for each quarter. And we're starting to see, hopefully, a return to revenue growth. You'll notice some gray bars in some of the earlier years. Those are products that we no longer sell. We discontinued a handful of products that were just not profitable at the scale that we were providing them. And so that left behind our blue, what we call the core revenues, really the optical genome mapping software and Ionic revenues. And so we're pleased with the progress that we've seen so far in 2025. And when we look a little bit deeper into these numbers, specifically at consumables and software revenue, we see importantly that it's growing, especially with our existing customers. And so the second quarter, we had mid-double-digit teens growth here of the combination of consumables and software selling into our existing customer base. And on the half year, some growth, so getting close to double-digit growth. And we expect this to continue to evolve and accelerate. There are many catalysts in the market such as the CPT codes, such as new versions of the software that we've introduced and other efforts that we believe will drive this growth going forward. So we're happy to see that growth. One of the leading indicators of future growth are the publications. And so in the second quarter of 2025, we had a record number of publications for a single quarter. And so we've seen this trajectory continuously over the past several years, and we expect it to continue. But this means customers are using the product, writing up their papers, publishing them, which means that new potential customers can see those publications and take the lead from it. Importantly, on the right-hand side, that tracks the number of published human clinical research genomes. You can think of that as individual samples or clinical research samples. It's doubled year-over-year in the second quarter. But importantly, we surpassed this 10,000 genomes published mark, and it's a substantial mark for us. And you can see that we've done that largely in just about 4 years -- 4 to 5 years as this -- that curve really starts to ramp up in 2021. And so these are the kinds of proof sources that enable folks to have the confidence to adopt the product and utilize it. I mentioned these CPT codes, but this is the one that was established in June of this year, covering constitutional genetic disorders. And we believe that, that will reduce barriers to adoption and enable folks to utilize optical genome mapping more consistently in the field. Then getting to the cost structure. And so on the left-hand side of this slide, you can see our non-GAAP operating expenses quarterly for the past several quarters. And I guess we woke up in 2023, and we said that the cost structure that was in place at that time was not going to be sustainable. And it took us some time, but we reduced costs drastically over the period of time that you see outlined here. Importantly, now because 2 points to fine align, we have a nice flat structure over the last couple of quarters. And I think that, that's a very positive development. Over that same period of time, our gross margin has expanded significantly. So we printed 52% in the second quarter. And so these are the types of trends that make us believe that we have a sustainable business that's growing. We know how to invest in and drive that growth. And so we need to see these trends to continue, but we're very encouraged with the progress that we've been making. Now lastly, for the remainder of 2025, we have reiterated our annual guidance of $26 million to $30 million on the top line. We raised our guidance of new systems installation. Previously, we had guided to 15 to 20 systems, but we've raised that to 20 to 25. And our Q3 revenue guidance that we gave on August 14, the Q2 call was $6.7 million to $7.2 million. So that would be another quarter of sequential quarterly growth if we're able to come in within that guidance range. And so we're happy with the progress that we've made so far this year, and we think that this really provides a solid endorsement for the strategic adjustments that we've made and for the stability of Bionano going forward in this significant opportunity. So with that, I want to thank everybody for attending and those of you in person as well as those of you on the webcast. Thank you very much.

I think we're out of time. So we'll wrap it up there.

Great, thank you.