Bionano (BNGO) Q1 2026 Earnings Transcript

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Date

Monday, March 23, 2026 at 4:30 p.m. ET

Call participants

  • Interim CEO and Chairman — Albert Luderer
  • Principal Accounting Officer — Mark Adamchak

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Takeaways

  • Leadership transition -- Albert Luderer assumed the role of Interim CEO, with Erik [last name not specified] remaining as an advisor to ensure continuity and assist in the long-term CEO search.
  • Flow cell sales -- 8,178 nanochannel array flow cells were sold, a 17% year-over-year increase and a record Q1 unit volume for the company.
  • Flow cell utilization by existing customers -- Sales to existing customers increased by 21% year over year, excluding flow cells sold with new systems.
  • Consumable revenue -- Generated $3.9 million, up 20% year over year.
  • Software revenue -- Reached $1.2 million, down 40% year over year due to a large prior-year deal satisfying ongoing user needs.
  • Other revenue -- Reported at $1.6 million, up 36% year over year.
  • Total Q1 revenue -- Reached $6.7 million, increasing 4% year over year and at the high end of management's $6.5 million to $6.7 million guidance range.
  • Gross margin -- Adjusted gross margin rose to 49%, up from 46% in Q1 the prior year.
  • Adjusted operating expense -- Increased to $9.1 million from $8.5 million in the prior-year period, reflecting disciplined cost management.
  • Cash position -- Ended the quarter with $24.7 million in cash, cash equivalents, and available-for-sale securities, including $10.3 million subject to restriction.
  • Supply constraints -- Flow cell supply constraints eased during the quarter, with further improvement expected for the remainder of the year.
  • Clinical reimbursement milestone -- The clinical lab fee schedule for 2026 reflected a 47% increase in the payment determination for the Category 1 CPT code for OGM in hematologic malignancies, rising from $1,263.53 to $1,853.22.
  • New CPT code added -- A new Category 1 CPT code for OGM in constitutional genetic disorders received a final payment determination of $1,263.53, effective January 1, 2026.
  • Publication activity -- 28 publications on OGM for rare diseases emerged in Q1, a 56% year-over-year increase, with the total number of samples analyzed up 225%, and 1,991 genomes published, reflecting a 158% increase.
  • Multiple myeloma study -- A major published study showed OGM identified relevant chromosomal abnormalities in 92% of patients previously normal by karyotyping and resolved 82% of samples that karyotyping failed, detecting additional pathogenic abnormalities in approximately 30% of subjects.
  • Industry conferences -- At the 2026 ACMG Annual Meeting, the company had 12 presented studies (a twofold increase), and its February symposium saw over 1,250 registrants and presentations demonstrating OGM scalability to 10,000 cancer samples per year at a fraction of long-read sequencing platform costs.
  • Debt repayment -- Management expects to fully retire its outstanding senior secured convertible debt in March, further simplifying the balance sheet.
  • Revenue guidance -- Full-year revenue guidance reaffirmed at $30 million to $33 million (5%-16% growth), and Q2 revenue guidance set at $7.5 million to $7.8 million (12%-16% year-over-year growth).
  • Cash runway -- Management expects cash runway to extend into 2027.
  • Profitability outlook -- Adamchak said, "No, we do not expect to reach cash flow breakeven by the end of 2026," and did not provide guidance on reaching breakeven during 2027.

Summary

Bionano Genomics (NASDAQ:BNGO) delivered record Q1 flow cell unit sales and achieved its highest Q1 total revenue to date, while simultaneously delivering a substantial gross margin improvement. The reimbursement environment advanced, with a 47% payment increase for OGM in hematologic malignancies and the introduction of a new CPT code for genetic disorders, positioning the company for increased clinical adoption. Major published evidence supported OGM's clinical utility, while new customer expansion focused selectively on routine users. Balance sheet simplification progressed through anticipated full debt retirement, and guidance points to continued sequential revenue growth in subsequent quarters.

  • Management highlights ongoing positive user feedback on software and compute upgrades that allow laboratories to double weekly cancer sample throughput using existing hardware.
  • The company noted that VIA remains a standard for copy number variation analysis, and its adoption among sequencing labs is expanding.
  • Software and consumables comprised an increasing share of revenue, reflecting a shift towards more predictable and recurring revenue streams.
  • Management identified operational efficiencies and product mix as drivers of the improved gross margin profile.
  • "people to identify how to do it. Today, it's all of our users that are out there, and they are setting the standard and the path. So they are now leading. And that's a huge transition, transformation for this company."
  • International momentum is evidenced by the 2026 symposium attracting participants from 73 countries, and highlighting OGM automation at scale.

Industry glossary

  • OGM (Optical Genome Mapping): A technique enabling high-resolution structural variation analysis of genomes, used for research and clinical diagnostics.
  • CPT code: A standardized code used for billing and reimbursement in clinical laboratory and medical services.
  • CNV (Copy Number Variation): A genetic variation involving duplications or deletions of DNA segments, detectable by technologies such as OGM and microarrays.

Full Conference Call Transcript

Albert Luderer: Thank you, Webb, and good afternoon, everyone. I'm pleased to be here with you all today. Now before I share an update on our first quarter, I want to address the recent leadership transition. As announced last week, I'm stepping in as Interim CEO and will maintain my role as Chairman. I would like to thank Erik for his commitment to Bionano over the last decade, bringing this company and our technology from concept to broad validation. I look forward to working with him as he maintains an advisory role to ensure a seamless transition.

Now as I step into the CEO role, my highest priority is to sustain business continuity to ensure no disruption to our valued customers and shareholders. Simultaneously, I'll be working closely with my fellow Board members to identify the best candidate to lead this organization over the long term, transforming Bionano from a company focused on R&D to one focused on commercialization and broad product adoption over time. Our focus remains on transforming pathology, the discipline that investigates the causes, developments and effects of disease from tedious, slow, costly and labor-intensive analog workflows in the past towards streamlined workflows of digital future designed by technology and platform consolidation, automation and powerful AI-driven software that make up our products and solutions.

Today, I will take some time to touch on 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 2024, we deliberately redirected our focus away from aggressive installed base expansion toward driving profitable growth with existing routine users while being selective about new customer acquisition, placing an emphasis on adding new routine users. Four strategic pillars define how we have and how we will 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, scalability, et cetera, through lower costs, higher volumes and continuous improvement in product quality. Now turning to our first and second pillars, which are focused on supporting our installed base and driving greater utilization of our products. Q1 2026 flow cells sold were up 17% year-over-year at 8,178 units, which is a record unit sales volume for any Q1 that we have reported.

Removing flow cells tied to sales of new OGM systems in both periods, flow cells sold to existing customers were up 21% year-over-year in Q1. Recall that we entered the first quarter with some constraints on flow cell production, but the supply is starting to catch up. We saw improvement in the first quarter and expect to see continued improvement in flow cell production for the remainder of 2026. Now breaking down our revenue segments. Consumable revenue was up to $3.9 million in Q1, up 20% year-over-year. Our strong growth in consumables revenue is evidence of our strategy in action as we prioritize routine users and focus on OGM.

Software revenue was $1.2 million in quarter 1, down 40% year-over-year as we had a very large software sale in the prior year that is expected to supply the user for their needs in both 2025 and 2026. Other revenue was $1.6 million in quarter 1, up 36% year-over-year. We believe this ongoing shift towards higher proportion of recurring revenues reflects a healthier, more predictable business mix and is directly aligned with our strategy. Now regarding our second pillar, increasing OGM utilization by supporting software adoption and menu expansion. We continue to receive very positive feedback on our recent software and compute upgrades.

These upgrades focus on enabling 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 amongst NGS and long-read sequencing labs continues to grow. These non-OGM VIA users represent both a durable software revenue stream and a natural entry point into broader Bionano adoption. We also continued development in support of our Ionic system, which delivers high-purity DNA and RNA for OGM and NGS workflow at scale. Now regarding our third pillar, building support for OGM reimbursement and inclusion in medical society guidelines.

I'm pleased to highlight 2 significant reimbursement milestones that both took effect in the first quarter. First, the 2026 clinical lab fee schedule reflected a 47% increase in the payment determination for the Category 1 CPT code for OGM and hematologic malignancies. The reconsidered payment determination is now $1,853.22, up from $1,263.53. This increase reflects meaningful advocacy work by our customers and the community, and it substantially improves the reimbursement economics for labs running OGM for cancer research. Second, a new Category 1 CPT code for OGM in constitutional genetic disorders established by the American Medical Association in 2025, received a final payment determination of $1,263.53, also effective January 1, 2026.

This code covers OGM use in evaluation of constitutional chromosome abnormalities, interrogation of structural and copy number variants. Together, these 2 codes now cover OGM's primary application areas and represent significant reimbursement infrastructure supporting routine adoption. The pricing of the constitutional code at $1,600 -- $2,663.53 (sic) [ $1,263.53 ] higher than what microarray's costs are priced at is consistent with the needs of laboratories seeking to move forward from their legacy methods. We believe these CPT codes reduce barriers to adoption and may pave the way for even more routine use of OGM across oncology and in clinical genetic research communities globally. On the publications front, momentum continues.

We announced that 28 publications describing the utility of OGM for analysis of rare diseases were released in Q1 2026, representing an approximately 56% increase over Q1 2025. The total numbers of samples analyzed in those studies, 78, represents a 225% increase compared to 2025. There were 1,991 genomes published in the first quarter of 2026, representing a 158% year-over-year increase over Q1 2025. These publications span a broad range of conditions, including neurodevelopmental, neuromuscular, neurodegenerative, immunological and malformation syndrome and comes from institutions across Europe, Asia, South America and the United States. I want to take a few minutes to highlight a few recent publications and presentations that really stand out.

First, in April 2026, a landmark study led by scientists from Johns Hopkins University School of Medicine and The University of Texas MD Anderson Cancer Center was published in the American Journal of Hematology, demonstrating that OGM can significantly outperform traditional analytic methods for detection of structural variation and chromosomal abnormalities in multiple myeloma. This was the largest published multiple myeloma cohort to-date with 211 samples. OGM identified relevant chromosomal abnormalities in 92% of patients previously found to be normal by karyotyping and successfully resolved 82% of multiple myeloma samples that had previously failed in karyotype altogether. OGM also detected additional pathogenic structural abnormalities not identified by karyotyping or FISH in approximately 30% of subjects.

The authors recommended revising laboratory workflows to include OGM and NGS, which we believe has the potential to drive growth and adoption and utilization of OGM in this large and very challenging indication. Second, a publication from the Sanford Burnham Prebys Medical Discovery Institute described the application of OGM to detect genomic alterations introduced by different gene editing technologies, including transposons, lentiviral transduction and CRISPR-Cas9 mediated locus insertion. This study demonstrated that OGM can be a valuable quality control tool for cell line genome integrity in preclinical and clinical development of gene editing therapies, reinforcing OGM's growing role in the pharmaceutical industry and cell and gene therapy development.

Third, at the 2026 American College of Medical Genetics and Genomics, or ACMG, Annual Meeting held this past March in Baltimore, Bionano had 12 studies presented, representing a twofold increase over 2025 and spanning cancer genomics, hematologic malignancies, constitutional genetic disorders, rare diseases and reproductive disorders. And finally, last but not least, Bionano Symposium 2026 held in late February brought together over 1,250 registrants from 73 countries and featured 35 outside speakers giving 33 presentations and 50 posters across 4 days. A defining theme was OGM at scale. Dr. Alexander Hoischen from Radboud University Medical Center described plans to reach 3,000 samples per year through full automation, while Dr.

Adam Smith of Labcorp demonstrated that a scaled Stratus workflow can process 10,000 cancer samples per year at less than 1/8 the capital investment of a comparable long-read sequencing platform. Symposium 2026 reinforced that OGM is moving from early adoption into scale. Now regarding our fourth pillar, the numbers speak for themselves on the profitability front. From a high 20% gross margin profile in 2023, we have systematically driven that figure higher over the past several years, reaching 49% in Q1 2026. Operating expenses have followed a similar trajectory of disciplined reduction. As revenue scales and our mix continues to tilt towards higher-margin consumables and software, we expect these trends to eventually carry us towards cash flow breakeven.

I'll now turn the call over to Mark Adamchak, our Principal Accounting Officer, to review our Q1 2026 financial highlights and provide and discuss our expectations for Q2 and the full year 2026. Mark?

Mark Adamchak: Thanks, Al. Revenue for the first quarter of 2026 was $6.7 million, up 4% compared to Q1 2025 and at the high end of our guidance range of $6.5 million to $6.7 million. As we noted on our Q4 2025 call, we expected Q1 to be the lightest quarter of the year, consistent with the typical seasonality of our business. We sold 8,178 nanochannel array flow cells, up 17% compared to Q1 2025. This growth was achieved despite an ongoing supply constraint, which we continue to see ease. Turning to profitability. Adjusted gross margin for the first quarter of 2026 was 49% compared to 46% in Q1 2025 and reflecting continued operational efficiencies under our strategy.

Adjusted operating expense for the first quarter was $9.1 million compared to $8.5 million in Q1 2025. We ended the quarter with $24.7 million in cash, cash equivalents 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. We also expect to fully retire our outstanding senior secured convertible debt this month, which marks a meaningful balance sheet milestone that further simplifies our financial profile. Building on this progress, we expect revenue to grow throughout the year as we continue executing on our plan.

For the full year 2026, we are reaffirming revenue guidance of $30 million to $33 million, representing growth of 5% to 16% over 2025. For Q2 2026, we are initiating guidance of $7.5 million to $7.8 million, representing 12% to 16% growth over Q2 2025. We are very excited about the work and the journey ahead of us at Bionano. With that, I will turn the call back over to Al for closing remarks.

Albert Luderer: Thanks, Mark. So Q1 was strong, very strong start to the year, and I'm encouraged by the momentum we're carrying into the rest of 2026. We have a clear strategy, a focused team and the technology the market is increasingly embracing. I look forward to updating you on our continued progress. And with that, let's open it up for questions.

Operator: [Operator Instructions] Our first question comes from Yi Chen with H.C. Wainwright.

Yi Chen: Could you provide some comment regarding, if you expect the company to achieve operating cash flow breakeven either late this year or sometime in 2027?

Albert Luderer: Thanks for the question. Let me ask Mark to comment on that. Mark?

Mark Adamchak: Yes. Thanks Yi. No, we do not expect to reach cash flow breakeven by the end of 2026. And we are taking the necessary steps that we can, to reduce that burn as much as possible by Q4 of 2027, but we're not providing guidance as to whether or not we can achieve that.

Yi Chen: Okay. And do you expect any additional catalysts that could potentially occur either later this year or in 2027 that could help the top line growth or improve gross margin or further reduce operating expenses?

Mark Adamchak: Well, I think there are several catalysts this year. The first catalyst, which actually was really planted in the first quarter, which is the CPT code and the strong reimbursement. So I think we are starting to see some impact in our dedicated installed base. It's a little hard to measure right now, but I think that's part of the reason we are experiencing a very, very strong demand. So we're pleased about that. The second one is, certainly, I think from my point of view, the elimination of our debt is a very strong step forward in terms of controlling our destiny and our future.

Now that doesn't mean we wouldn't take other debt for certain applications if it was called for and timely. But -- so I think that's a big deal. And I think those are the 2 major things that we are pushing. And we have several publications that are coming out that will be highly complementary and also expansive on what's been shown by Hopkins and MD Anderson. So we're getting great adoption out there. So I think we're going to try to make it very public about how people feel about this. And the neatest thing about this -- and I've been a director of this company since 2011. So I have lived through this.

And in the early days, it was our clinical medical executives who were -- who are identifying what could be done and helping people to identify how to do it. Today, it's all of our users that are out there, and they are setting the standard and the path. So they are now leading. And that's a huge transition, transformation for this company.

Operator: [Operator Instructions] That will conclude today's question-and-answer session. This concludes today's conference call. Thank you for participating. You may now disconnect.

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