Bionano Genomics, Inc. Q2 FY2024 Earnings Call

Thank you, operator and good afternoon everyone. Welcome to the Bionano second quarter 2024 financial results conference call. Leading the call today is Dr. Erik Holmlin, CEO of Bionano. He is joined by Gülsen Kama, CFO of Bionano. After market closed today, Bionano issued a press release announcing its financial results for the second quarter of 2024. 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 including statements about Bionano's revenue outlook, profitability, cash runway, cost savings initiatives, and commercialization and product plans. Such statements are based on current expectations and there can be no assurances that the results contemplated in these statements will be realized. Actual results may differ materially from such statements due to a number of 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, August 7th, 2024, and the company assumes no obligation to update statements as circumstances change. In addition to supplement Bionano's financial results reported in accordance with U.S. generally accepted accounting principles or GAAP, the company reported certain non-GAAP financial measures. A description of these non-GAAP financial measures as well as a reconciliation to the nearest GAAP financial measures are included at the end of the company's earnings release issued earlier today, which has been posted on the Investor Relations page of the company's website. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute to comparable GAAP measures, should be read in conjunction with the company's consolidated financial statements prepared in accordance with GAAP, have no standardized meaning prescribed by GAAP, and are not prepared under any comprehensive set of accounting rules or principles. An audio recording and webcast replay for today's conference call will also be available online on the company's Investor Relations' page. With that I would like to turn the call over to Erik.

Thank you, David, and good afternoon everyone. Q2 2024 was significant for the progress made towards the worldwide acceptance of OGM and it's also the quarter where the majority of staffing reductions conducted to our cost-savings initiatives took effect, which means we're learning how to operate within a streamlined team. I also think it's important to acknowledge that in the midst of our solid execution, we are facing a challenging and turbulent economic backdrop. This challenge includes the broader equity capital markets and limitations to the financing options available to us. But I want to underscore that while management is frustrated by these challenges, our focus remains on moving OGM forward. And with that, I want to start off the call today by discussing the recent decision of the editorial panel of the American Medical Association or AMA to accept the application for a Category 1 CPT code for the use of optical genome mapping in cytogenomic genome-wide analysis to detect structural and copy number variations related to hematological malignancies. We believe the CPT code will enable the adoption and utilization of OGM to increase significantly. It's a key component that labs can leverage to obtain reimbursement from insurance companies and Medicare when they use optical genome mapping for clinical testing. And that includes, of course, the reimbursement of OGM-Dx HemeOne, our laboratory-developed test offered by Bionano Laboratories. And importantly, given that the criteria used by the AMA for Category 1 CPT code approval is rigorous and includes input from stakeholders across the healthcare community, we view the decision to establish a code for OGMs as indirectly reflecting OGMs increasing maturity and utility. It's a really significant milestone for us and for users of OGM, and we're very proud of the outcome and we're seeing a positive benefit already. Now, I'd like to give an overview of the quarter. Revenue for the quarter was $7.8 million and that includes $700,000 of revenues associated with clinical services, which we have previously discontinued. The second quarter 2024 revenue represents a 10% year-over-year decrease compared to the same period of 2023. But keep in mind that includes a 53% reduction in revenues tied to these discontinued clinical services. The OGM installed base grew to 363 systems during Q2, representing a net increase of 16 systems and 29% growth over the installed base at the end of the second quarter of 2023. We sold 6,165 flowcells in the second quarter of 2024, which represents a year-over-year decrease of 13% compared to the 7,062 flowcells sold in the same period last year. In fact, this quarter is the first in 20 consecutive quarters where flowcells sold declined on a year-over-year basis. Looking into that result a little bit more, we see that in Europe, flowcells sold grew in the quarter, but in the Americas and in the Asia Pacific region, the number of flowcells sold declined. The decline relative to the second quarter of 2023 was most significant on a percentage basis in China. And that's been driven by our OEM partners and key customers falling behind on their committed or expected purchases in the quarter. We estimate that this shortfall was approximately 1,200 flowcells. This underperformance in China is a function of both the slowdown in funding for companies in the region, which has been well publicized and well-known, and it's also a function of our OEM partners awaiting approval from the National Medical Products Administration or NMPA of China to evaluate Saphyr systems there, so that they can be sold directly into hospitals under a clinical intended use designation. We see the potential for this delay in China business to persist and that's something that we factored into guidance for Q3 and for the full year. Now, regarding the decline in the Americas region, we see two factors coming into play. One is for existing Saphyr sites that have adopted Stratys, where we've seen a slowdown in their expected purchases, which we attribute to the process of transitioning from one system to the other. This effect is something we think we can mitigate going forward with additional Stratys sites by helping them plan the transition in advance. The second is the impact of the reduction of force connected to our cost savings initiative, which has reduced the number of field sales and support team that would normally shepherd these processes forward. Overall, for the first half of 2024, the total number of flowcells sold were up 17% and we are expecting a strong third quarter as we adjust to these new staffing levels. Some key highlights in other areas of the business include a Software Marketing Agreement into which we entered with Revvity, under which Revvity will market and commercialize our VIA software as part of its Newborn Sequencing Research workflow. Publications grew. With 72 publications in Q2, the total number of publications from the first half of 2024 grew by 37% compared to the same period in 2023. The total number of clinical research subjects covered in publications in the first half of 2024 has grown by 136% from the same period in 2023. And in July, a peer-reviewed publication on the first phase of our prenatal multisite study was published, which showed for 200 samples or 123 unique cases that OGMs overall accuracy was 99.6%. Its sensitivity was 99.5%, specificity was 100%, as was the PPV at 100% and the Negative Predictive Value or NPV was 95.5%. Additionally, OGM was 100% reproducible between sites, operators and instruments. We have continued to ship commercial production units of the Stratys system and the ongoing feedback around Stratys continues to be positive. And we also released a series of major advancements to our entire suite of comprehensive analysis software tools for cancer including Version 7.1 of our VIA software. These advancements enhance the detection and interpretation of angiosomes, which are important in cancer, and improve the analysis, visualization, interpretation and reporting of data types including optical genome mapping, next-generation sequencing or NGS as well as microarrays. Before looking ahead to the remainder of 2024 and our expectations, I would like to turn the call over to Gülsen who will walk you through the financial results.

Thanks, Erik. As Erik mentioned, revenue for the quarter was $7.8 million. GAAP gross margin for the second quarter was 33% compared to 27% during Q2 2023 and non-GAAP gross margin was 35% compared to 29% in the same quarter last year. Second quarter 2024 GAAP operating expense was $19.6 million and non-GAAP operating expense was $18.8 million. These reports show decreases of 53% and 46% respectively from the second quarter of 2023. Our cash, cash equivalents and available-for-sale securities as of June 30, 2024, were $30.3 million, of which $11.4 million was subject to certain restrictions. Regarding financing activity in the second quarter and subsequently, we have completed two registered direct offerings and restructured our debt. In April 2024, we completed a $10 million registered direct offering which resulted in $9.3 million of net proceeds to the company, after deducting the placement agent fees and other offering expenses. In May, we completed a private placement of senior secured convertible debentures due May 2026 which resulted in gross proceeds of $18 million. Concurrently, we retired the outstanding balance of the convertible debt which we entered into in October of 2023. As of June 30, 2024, the aggregate principal amount of senior secured convertible debentures outstanding was $20 million. The structure of the new debt provided us with significant financial flexibility by retiring near-term debt maturities and deferring principal redemption payments. In July, we completed another registered direct offering with upfront gross proceeds to the company of $10 million and a concurrent private placement of clinical milestone linked Series A and Series B warrants. The warrants have potential additional gross proceeds of up to $20 million, if exercised for cash and are exercisable only upon stockholder approval. We will be filing a proxy statement for a special meeting of stockholders that we expect to be held in early October. Back to you, Erik.

Thanks, Gülsen. Looking ahead to Q3 and to the remainder of the year, our focus is on balancing the need on the one hand to reduce expenses and operate with fewer employees with the other the need to realize the full potential value in converting traditional cytogenetics to OGM. Regarding expenses, we began reducing them in May of 2023 and that continued in October of 2023 and then in March of 2024. Our plan was to reduce annualized non-GAAP expenses relative to the annualized non-GAAP operating expense in March of 2023 by a total of $65 million to $75 million. The savings are expected to be fully realized in the first quarter of 2025, and we're progressing well towards this goal as is evident in the 46% or $15.8 million reduction in non-GAAP operating expenses in the second quarter of 2024, compared to the same period a year ago. In addition to those initiatives, management will remain vigilant towards further streamlining our operations and extending the savings. And we recognize as we do this, it has the potential to impact future results. And so that's something that we will pay close attention to. We are still in the process of adapting to our streamlined operational model and it may be partially to blame for not being able to overcome some of the challenges we face in China and other areas of the business this quarter. Our management team continues to focus on shoring up any gaps in commercial execution and other areas of the business that might be coming from organizational change. Our efforts to continue driving growth include planned advancements to the workflow and ongoing efforts in market development to support reimbursement. We have additional important advancements that are slated for this year. In the fourth quarter, we plan to release improvements to the data analysis processing time on the Stratys compute system, which is a high-performance computational workstation developed in collaboration with NVIDIA to support higher sample throughput for our customers. We are addressing the DNA isolation challenges that come with optical genome mapping using isotachophoresis technology on the Ionic system. We have completed pre-commercial evaluation of OGM on the Ionic system with a newly developed isotachophoresis cartridge, which is specific for isolation of ultrahigh molecular weight DNA at two different sites and third is currently underway. Feedback on this new workflow has been positive and it includes validation of Ionic's ability to reduce OGM sample to answer workflow to as few as two days. We're planning a full commercial release of the product later in the year likely in the fourth quarter and we believe the enhancements to the Stratys compute and Ionic will enable more samples to be processed by labs using the same number of technicians. Our clinical studies program is really focused on advancing the Heme trial and supporting the continuing publication of more pre and postnatal study data from the constitutional trials like the publication that appeared this July. In fact, relating to the Heme trial and a preliminary readout, Dr. Phillip Michaels from Harvard Medical School presented interim results this week at the Cancer Genomics Consortium meeting in St. Louis. The data showed that optical genome mapping detected pathogenic findings in 42% of cases that were otherwise negative when they were evaluated by standard of care testing such as Karyotyping and Fluorescence In Situ Hybridization or FISH. The turnaround time of optical genome mapping from sample to report was four days and the cost was lower than Karyotyping alone and so clearly lower than the combination of Karyotyping and FISH. So this is incredible progress that we're seeing and we will continue to invest in the Heme trial going forward. And with regard to guidance for the remainder of the year, we remain on track to meet our goal of installing 381 to 401 OGM systems by the end of 2024. And this reflects some upgrades of Saphyr to Stratys in the process. We expect the third quarter revenues to be in the range of $7.9 million to $8.9 million. And given the slowdown that we're experiencing in China, we expect our full year revenues to end up at the lower end of the range given previously. And therefore, we're adjusting our full year 2024 revenue guidance to be $36 million to $40 million down from $37 million to $41 million. And we understand that we may see some slower growth in the adoption and expansion of optical genome mapping as a result of further expense reductions. But we believe that cash preservation and profitability are more and more in targets than growth at any cost. In closing, I'm pleased with the progress we have made in the first half of 2024 and we remain committed to disciplined cash management and running an efficient organization and we continue to believe that we will transform the field of cytogenetics with optical genome mapping. And so operator, with that, please go ahead and open the line for questions.

Thank you. Our first question will come from Jeff Cohen from Ladenburg Thalmann & Co. Your line is open.

Hi, this is Destiny standing in for Jeff. I have a couple of quick questions. Regarding your lower guidance, is it primarily due to the reduced staffing? What I would like to understand is what portion of that is actually due to the lower head count and how much is related to the transition to the Stratys system?

Yes, I think we adjusted the range down by $1 million. Thank you, Destiny, for the question. The underperformance in China likely accounts for that adjustment, and we expect that China may continue to underperform for the rest of the year. The fact that China is not recovering is probably the main reason for this change. I’m not really modifying the full-year guidance based on some of these other factors because I believe they are more temporary and can be resolved as the year progresses.

Okay. All right. That makes sense. And then I just was wondering what are some of the broader implications of the results from the multisite study in multiple myeloma? And how would you say you're planning to leverage these findings to advance other product offerings and expand within the market in general?

Yes. Okay. So I want to be clear on a couple of things. So, there's a really outstanding publication that came out in the quarter covering multiple myeloma. And that's not something that I spoke about here in the scripts, per se, I spoke about our multisite study which is addressing hematologic malignancies across the board. But let me talk about multiple myeloma because it's in a really important indication. And that publication that came out is key. And so multiple myeloma is a significant form of hematologic malignancy. And one of its characteristics is that there are effective treatments for canonical multiple myeloma, but the cell type tends to be refractory to cell growth in the lab. Cell growth is required to perform standard-of-care testing, karyotyping, for example. And so multiple myeloma is an indication where an alternative that does not rely on cell growth and cell culture would be very powerful. And so when you look at this study in multiple myeloma where the results are really significant, I think it means that there is the potential and certainly we believe in this potential that labs can not only adopt optical genome mapping for other leukemias like AML, ALL, CML, CLL, but also for multiple myeloma. And so it really expands the opportunity for adoption or for existing sites to grow their utilization. That's really significant in the multiple myeloma results because it's a new indication within hematological malignancies. When we look at the trial results that were presented on a preliminary basis at this conference, those trial results are significant because they start to get at the fundamental health economic and outcome benefits of optical genome mapping being used in a clinical setting. And so those benefits are being quantified in this study and are going to play key roles in insurance coverage decisions that will be made in the next nine, 12, 18 months. And so we've seen that most of our trial study results have gotten at things like does OGM work as well as the standard of care and now these trial results are getting to say, well, it works as well as, but how much better and not only how much better, but how many study subjects or patients are impacted by those results. So, both are very significant.

Thank you for all the detail. I appreciate it. I want to follow up on the ionic system. I understand you are still on track for a full commercial launch in the fourth quarter. Can you provide any additional details? Also, how is the backlog looking in terms of interested parties? Thank you for taking my question.

Yes, you're welcome. I want to highlight that the ionic system, brought into the company through the acquisition of Purigen Biosystems, provides us with a proprietary technology for isolating ultrahigh molecular weight DNA, outperforming all other current options. We've been adapting this workflow for optical genome mapping, and the field tests with pre-commercial units have yielded very positive results. Customers value the speed and reduced hands-on time of this ultrahigh molecular weight DNA isolation, and the standardized workflow is crucial for high-volume labs, minimizing errors. This has attracted the interest of customers who are operating optical genome mapping at scale, particularly those using Stratys and Saphyr, and are looking to increase their volume. However, we remain cautious about building a sales pipeline until the product is ready, as we want to ensure we can meet customer expectations for both performance and timing.

Thank you. One moment for our next question please. Our next question will come from Eduardo Martinez-Montes from H.C. Wainwright. Your line is open.

Hi there. Thanks so much for taking the question. I had a question regarding the recent reimbursement with the CPT code that you guys announced, and when you should expect to see changes in revenue and that would be forecasted in your guidance?

Thank you, Eduardo, for your question. When we speak with people on the buy side, they often ask what question our sales reps get asked the most frequently. In the United States, that question is whether there is a CPT code for our service. With the recent acceptance of our application for a code, we now have a positive answer to that, which is beneficial for our sales process. Although it's anecdotal, we have observed that the acceptance and publication of the code have already influenced some accounts and started to speed up their purchasing decisions. However, I want to be cautious about overemphasizing the short-term impact of this CPT code on revenues. Our current revenue projections account for having a code, but several additional steps are necessary. The first step involves determining the pricing for the code, which will be effective and listed on the clinical lab fee schedule starting in early 2025. The crucial question is at what price CMS will set it. They are currently reviewing this and have been holding meetings related to our application, following their standard timeline, so we should see the pricing details soon. The price of the code could significantly impact its adoption. There are several Proprietary Laboratory Analyses codes available, which may serve as a benchmark for the pricing of our CPT code. Once the price is set and the code is posted on the clinical lab fee schedule early next year, payers will then make coverage determinations. Medicare is actively working on this, and we applied for it at the end of 2023, so we anticipate coverage decisions to emerge in early 2025. Other Medicare administrative contractors will also assess OGM and determine coverage. Overall, we envision a progressive transition from the CPT code to pricing and then to coverage. As this process advances, more customers will gain confidence in implementing optical genome mapping, with many already preparing to adjust their pipelines and workflows to OGM once the reimbursement is confirmed. Thus, we expect adoption to be influenced in the short term and utilization to increase as coverage is formalized in 2025.

That's great. That's really insightful. And congrats again on getting the code. I had another question regarding the recent deal with Revvity and kind of if you guys envision more deals like this and kind of the role that VIA and software-as-a-service might play in your forecasting as well?

Well, so thank you. And I mean, I think that the Revvity deal, and I want to be clear about how it works. Revvity has a pretty comprehensive offering for Newborn Sequencing Research and there are a variety of analyses that they conduct. And our software, the VIA software provides critical insights into the presence of certain variant types from NGS data, from next-generation sequencing data. And so that's highly complementary to what we're doing with optical genome mapping. And it's not technically limited to just new screening. So we see that as being attractive for what Revvity is doing. That's not a market that we would go after, but it's significant and can drive significant utilization of our software and revenue accordingly. But you can imagine that there are other examples of NGS analysis, where the VIA software can provide a lot of value. And so I would say that the answer to your question is that yes, we see the potential for other deals, and end-user sales of the software for applications outside of OGM are meaningful revenue contributors to the top line today and margin. I mean the software is a very high-margin product. So as a life sciences solutions provider, the software that we provide is a revenue driver, a value driver, and a source of significant growth potential going forward.

Thank you. And that does conclude our question-and-answer session for today's conference. I'd now like to turn the conference back over to Erik Holmlin for any closing remarks.

Thank you, Crystal, and thank you to everyone who has joined the call today and we look forward to updating you on our next report. Good afternoon.

Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.