Bionano Genomics (BNGO) Q4 2024 Earnings Call Transcript

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Bionano Genomics (NASDAQ: BNGO)
Q4 2024 Earnings Call
Mar 31, 2025, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and welcome to the Bionano fourth quarter 2024 earnings conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to David Holmes from investor relations. Please go ahead.

David Holmes -- Investor Relations

Thank you, operator, and good afternoon, everyone. Welcome to the Bionano fourth quarter 2024 financial results conference call. Leading the call today is Dr. Erik Holmlin, CEO and principal financial officer of Bionano, and he is joined by Mark Adamchak, 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 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, margins, 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.

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Actual results may differ materially from such statements due to several factors, including risks 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, March 31st, 2025, 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 reports 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 be considered in isolation or as a substitute for comparable GAAP measures, should be read in conjunction with the company's consolidated financial statements prepared in accordance with GAAP, and have no standardized meeting prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles. An audio recording and webcast replay from today's conference call will also be available online on the company's investor relations page. With that, I'll turn the call over to you, Erik.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Thank you, David, and good afternoon, everyone. I'm pleased to provide you with an update on the fourth quarter of 2024, as well as the full year 2024. While we continue to find ourselves in unprecedented times in our industry, our core business, based on sales of instruments, consumables, software, and optical genome mapping services, is progressing well. I'd like to start off by taking everyone through our results for the quarter.

Total revenue for the fourth quarter of 2024 was $8.2 million, a decrease of 24% compared to the fourth quarter of 2023, which included $2 million from discontinued clinical services compared to no revenues from such clinical services in Q4 2024. GAAP gross margin for the fourth quarter of 2024 was 42%, which is significantly higher than the 23% GAAP gross margin reported in the fourth quarter of 2023. Non-GAAP gross margin for Q4 2024 was also 42% compared to 24% for the fourth quarter of 2023. Fourth quarter 2024 GAAP operating expense was $15.4 million compared to $27.4 million in the fourth quarter of 2023.

The year-over-year decrease was primarily due to a decrease in the fair value of contingent considerations of Purigen milestones and importantly reduced headcount related expense attributed to the cost savings, initiatives that have been outlined in our Q2 2023 and Q3 2023 earnings release. Fourth quarter of 2024 non-GAAP operating expense was $10.6 million compared to $26.6 million in the fourth quarter of 2023. Cash, cash equivalents, and available-for-sale securities as of December 31st, 2024, were $20.9 million, of which $11.4 million was subject to certain restrictions. We raised net proceeds of $3.6 million from ATM sales during the fourth quarter of 2024.

Additionally, we modified the terms of our senior secured convertible debentures, among other things, which include -- which deferred the $1 million December 2024 amortization payment and reduced the monthly payments from January 2025 to July 2025 by 50%. And we completed a $10 million registered direct offering in January 2025, along with raising net proceeds of $3.2 million through ATM sales during the first quarter of 2025. We now believe our cash runway extends into the first quarter of 2026. Product revenues, instruments, consumables, and software for the full year was $27 million, an increase of 1% compared to $26.7 million in 2023, despite a reduction in instrument sales of nearly $2 million.

Consumables sales were $12.8 million, an increase of 14% from $11.2 million in 2023. And software sales for the full year were $6.2 million, an increase of 11% from $5.6 million in 2023. Sales in the Americas region were up 9% in 2024. And sales in the Europe, Middle East, and Africa region were up 10% in 2024 compared to 2023.

We sold 30,307 nanochannel array flow cells during 2024, including 8,058 in the fourth quarter, which represents a 15% increase over the 26,444 flow cells sold in the full year of 2023, an increase of 1% over the 7,980 flow cells sold in the fourth quarter of 2023. Full year 2024 GAAP gross margin was 1%, which is down from 26% in 2023, but that was after a series of one-time noncash adjustments. Non-GAAP gross margin for the full year of 2024 was 35%, which is up from 28% in 2023. Finally, full year 2024 GAAP operating expense was $104.4 million, and non-GAAP operating expense for the full year of 2024 was $68.9 million.

The tremendous progress across the business absolutely reflects the heroic and stellar efforts of our associates, whom we affectionately call transformers, for the impact they are making around the world. They have our most heartfelt and sincere thanks for these incredible contributions. I would like to use the remainder of the call to discuss the plan going forward. We believe that along with other companies in the life sciences and tools industry, we are in a period of recalibration in how the market will embrace novel technologies like ours for medical research.

Keep in mind our major economic engine is optical genome mapping, or OGM for short. OGM is used to transform the cytogenetic workflow in four key areas: hematologic malignancies, constitutional genetic disorders, solid tumors, and cell and gene therapy. Applications of optical genome mapping in solid tumors are emerging and relatively novel to our list, but publications from users are demonstrating the utility. And so, we now see them as a key driver, alongside the other three going forward.

Now, in September of 2024, we implemented a shift in our go-to-market strategy that moved away from the relatively heavy spending on growing the optical genome mapping installed base through customer acquisition, toward a focus on conserving cash and concentrating on those customers who use their Saphyr and Stratys systems routinely in cytogenomics. This strategy has four key pillars, which are: to support and sustain the install base of these routine optical genome mapping and, importantly, VIA software users; to drive utilization and increase it through the adoption of VIA software across our routine optical genome mapping user sites, which we believe will facilitate menu expansion; to continue building the support needed for optical genome mapping reimbursement and inclusion in medical society recommendations and guidelines; and to improve profitability and scalability with lowering costs and increasing sales volume. The first pillar is critical. What we see is consistent growth of consumable sales, even as our focus has turned away from aggressively adding new customers and new instruments.

The reason for this pattern is that a core group of users, approximately 118 customers, account for more than 80% of consumables purchases and growth that we've seen over the previous two years. These customers are primarily in the United States, Canada, Europe, and Israel. And this group tends to use optical genome mapping routinely as an alternative to traditional cytogenetic methods, meaning they have a steady flow of samples to run that is not solely dependent on grant or project funding. These routine users are where we concentrate our efforts, which is more cost effective for us.

And on average, they generate a higher rate of revenues per customer compared to others that are not in that routine use group. We expect this routine use group to grow over time and to expand its use of optical genome mapping consumables and, therefore, be the primary driver of the expansion of the menu of applications of optical genome mapping to promote revenue growth. We have an ability to encourage this growth by enabling the customers to use our VIA software, which streamlines their workflows and increases their capacity to run more samples. VIA software is used by 133 customers for analysis of non-OGM data types and provides a significant source of revenues.

VIA has now been installed at over 160 OGM customers, which is up from just 40 at the end of 2023. This expansion in VIA installations creates the opportunity for us to get them proficient in using VIA, which we believe will increase their productivity and potentially be a source of consumables revenue growth on a per-site basis. Now, to continue building the support needed for optical genome mapping reimbursement and drive inclusion in medical society recommendations and guidelines, we need to remain active in encouraging and supporting, where possible, the publication of OGM data. Publications have continued to increase impressively, including 19% growth in 2024 of total publications and 39% growth of publications in combined clinical research and cell and gene therapy.

We have also seen an ongoing increase in published clinical research genomes, which we believe reflects the expanding adoption and use of OGM and, in turn, has the potential to influence people and agencies responsible for reimbursement and guidelines, showing this critical mass of adoption and utilization. We have already seen what we believe is a benefit to these publications with the decision by the American Medical Association to establish a Category 1 CPT code for OGM use in hematologic malignancies. This CPT code became effective on January 1st of this year. And to our knowledge, it's being used.

Lastly, our focus must remain on a disciplined approach to keep costs down. We have been successful in reducing costs and maintaining the momentum in the business, and we are seeing benefits in another key area, which is our gross margin. Over the past eight quarters, we have seen non-GAAP gross margin increase from 22% in the first quarter of 2023 to 42% in the fourth quarter of 2024. We do expect ongoing volatility in margin going forward.

And for that reason, we won't be providing guidance on margin at this time, but we are encouraged with what we are seeing. To wrap up, I would like to provide our outlook on 2025. With our key strategic pillars as the underpinning of our streamlined business focus, we expect full year revenues for 2025 to be in the range of $29 million to $32 million. First quarter revenues for 2025 are expected to be in the range of $6.2 million to $6.3 million.

And we expect to install 15 to 20 new optical genome mapping systems, primarily at routine use sites, including at existing customer sites, as well as adding new customers that fit into this routine use group. With that, operator, please go ahead and open the line for questions.

Questions & Answers:

Operator

[Operator instructions] And our first question for the day will be coming from Sung Ji Nam of Scotiabank. Your line is open.

Sung Ji Nam -- Analyst

Hi. Thanks for taking the questions. Erik, in terms of guidance, you know, based on kind of what you guys are providing, it kind of implies flattish growth year over year. Obviously, you talked about, you know, the strategic prioritization that the company has gone under.

And so, would you have a sense of kind of what the core revenue growth is contemplated in terms of your guidance for '25?

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yeah, it's all core now. So, 29.1 core going to 29 to 32.

Sung Ji Nam -- Analyst

OK, got it. And then, just curious about whether there are Saphyr trade-ins taking place as well. Or just as we look at the install base, should we expect continued placements of Stratys? You know, just trying to understand kind of what the net-net install base could look like.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yeah, I want to sort of start working with you and others to undertake a shift in our focus. And, you know, for the first time, we've actually really dug into this install base. And we're really going to focus on these routine use customers, of which there are 118 exiting 2024. And I think, you know, over time, we're going to see that group expand.

And if -- we will, I think, continue to report install base of optical genome mapping systems, but we're not going to guide to it, partly for the reason that you've said, which is that there could be trade-ins, there could be, you know, different things happening at customer sites that might be like a net zero. And so, we don't want that to reflect negatively upon us. So, we're going to talk about what we expect to install going forward. And we're going to spend a lot more time talking about this routine use customer group, the 118 right now.

And then, we hope to get into some metrics like their, you know, revenue per customer, which you can already get at that because these customers account for about 80% of consumables revenues. And so, you know, that's right around $10 million spread across 118 customers. And so, as you can see, the, you know, revenue per customer is in that 85K to 90K per customer range. And we think that that's the important thing to pay attention to.

And one last comment in this rather long answer is that another reason not to focus on the number of systems installed at their site is that some customers have brought in systems that they don't use on purpose. They're backup systems. And so, we don't want to skew the revenue per system. We want to focus on revenue per customer.

Sung Ji Nam -- Analyst

That makes sense. And then, lastly, just on the Stratys Compute, which you launched in collaboration with NVIDIA. Just kind of curious kind of what the early feedback has been and also how you expect that to drive continued utilization for your core customers. Thank you.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yes, I mean, it's positive for us. And I would say that, in general, kind of where we're at with Stratys Compute is that it's compatible with the Stratys system. So, something that Stratys sites use. Saphyr customers can get comparable performance by using multiple of the Saphyr computes.

But we have in our pipeline software updates that will be rolled out to the Stratys Compute to really continue to improve its speed. And it's going to be one of the sort of like circles that we go through. You know, customers who are using it, they always want more speed. That's fine.

We're going to give them more speed, but then we're going to train them on VIA, and they're going to start running more samples. They're going to need more speed. So, we hope to have a process of being able to continuously update and advance our software over time to provide those levels of acceleration.

Sung Ji Nam -- Analyst

Gotcha. Thank you so much, Erik.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Welcome, Sung Ji.

Operator

Thank you. And our next question will be coming from the line of Jason McCarthy of Maxim Group. Your line is open.

Michael Okunewitch -- Maxim Group -- Analyst

Hey, guys. This is Michael Okunewitch on the line for Jason. Thank you so much for taking my question today.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Hi, Michael.

Michael Okunewitch -- Maxim Group -- Analyst

Yes, just I guess on the focus with customer acquisition, you did mention you're not looking to aggressively seek customer acquisition now with the expense reduction complete. But are there any areas that you do plan to continue looking at acquiring new customers that may be lower cost of acquisition or higher utilization where they may go right into that 118 group of routine users?

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yes, I mean, I think that we will see growth of this routine user group to add new customers and that that will happen in our target geographies, certainly in Europe. But in the U.S., if you think about it, we've only just gotten started with these routine user sites. And the effectiveness of the CPT code as of January 1st, we believe, has the potential to be a catalyst for sites coming on board. And so, we're prepared.

We have the inventory. We have everything we need to support these sites. And, you know, our sales and marketing strategy there is going to be more around leveraging the amazing data that are being published and, of course, the success that these routine use sites are having and are talking about at conferences. So, we will be adding sites.

And, you know, we're only going to be adding ones where the customer acquisition cost is, you know, acceptable for the investment that both us and the customer make.

Michael Okunewitch -- Maxim Group -- Analyst

All right. Thank you. Then, just looking at the Category 1 CPT code, obviously, this has been a goal for a while. Good progress.

But is that something that's application-specific or could this be applied across any use of OGM?

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

It has some specificity to it, so it's specific to the use of optical genome mapping and hematologic malignancies. But, you know, that's a very, very, very large category, but it would not apply, for example, to the use of optical genome mapping for constitutional genetic disorders, for example. And what we know is that a lot of sites that are using OGM for that application either have a PLA code, which they use, or they, you know, bill for optical genome mapping as a reflex to normal test that they get by standard of care, and that seems to be a reasonably effective path for them. Hopefully, over time, there will be a CPT code for that application as well.

Michael Okunewitch -- Maxim Group -- Analyst

Thank you. And then, one last one from me, and I'll hop back into the queue. But I just wanted to see if you could provide a bit more color on that second pillar you talked about, driving utilization through software adoption. And specifically just if you could go into the mechanics of how VIA adoption could support increased utilization and what the interplay is there with menu expansion.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yeah. So, know, VIA automates a number of steps that a user follows to take their post-data generation and even, you know, the sort of primary analytical step of generating variant calls. After that step, you know, in a pre-VIA world, it was necessary for a user to essentially manually curate the list of variants by comparing it to what was known in the literature, comparing variants on the list to what medical societies may have recommended for that type of research analysis. In that particular indication, let's say, they're working in AML or CML or something of that nature.

They'd want to be guided by what's out there in the literature. Well, VIA, for that sort of research, automates that process. So, it takes a pretty extensive manual curation process and completely automates it. It not only automates that curation, but then generates a report.

After the curation was done manually, there would need to be a process of quite literally copying and then pasting from Excel into a report format, but VIA automates that. So, automated curation, automated reporting. And I can tell you that there are, you know, tens of variants that need to be combed through on virtually every sample. And so, by automating those steps, it means that the labs can get through that much more quickly.

If they're going through these samples more quickly, they can run more per-unit time. And what we know about sites is, you know, let's say they decide to adopt for hematologic malignancy. Let's say they're doing, you know, AML, which is a very common anchor assay, they have a lot of samples for other indications. And so, they will -- they would love to be able to add additional indications.

And by streamlining the process, it will give them the capacity that they require.

Michael Okunewitch -- Maxim Group -- Analyst

All right. Thank you. I really appreciate the additional insights there. Thank you very much for taking my question.

Congrats on all the progress, guys.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Thank you, Michael.

Operator

Thank you. And our next question will be coming from the line of Mark Massaro of BTIG. Your line is open.

Unknown speaker -- BTIG -- Analyst

Hey, folks. This is Vivian on for Mark. Thanks for taking the questions. So, I heard your comments on the shift toward focusing utilization of your existing install base.

Could you just share some color on how the strategy is playing out? I heard you on the 85K to 90K rev per customer metric. I understand it's early days, but do you see room for further expansion there, or do you think you're kind of saturated there? Thanks.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Sure. Thank you, Vivian, and thank you for the question. So, in undertaking this shift and just thinking about all of the metrics that we cited, you know, 9% growth year over year in the Americas, 10% in Europe, 14% in consumables growth overall, this progress took place with kind of a Bionano idiosyncratic backdrop of, you know, massive shift in how we were operating as a company. So, at the end of 2023, December 31st, 2023, I think we reported 344 employees.

December 31st, 2024, we reported 100 employees. And so, over the course of this past year, we had, let's just say, a lot of change happening. And I'm mentioning all of these things because I want to say despite all of that, consumable sales grew by 14%. Then, when you look at what drove that growth, you can see -- you know, if you looked at one of the slides that we presented, that growth was in this group of so-called routine users.

And those are the ones that we decided to focus on. So, what we believe is that the strategy has fallen into place effectively and is working. And, you know, we couldn't be happier with the adoption that we are seeing and the utilization that's happening. And generally speaking, and I'm not -- I don't want to guide, at least internally, we do believe that there is substantial room across an entire routine use group for that average to go up significantly.

We want to be cautious about talking about how quickly, but it doesn't have to go up by a lot to make a significant dent in the overall profitability for the company, for example. And so, we believe that that is, you know, going to happen. And it's kind of what our long-term plans are based on. And it's why we are focused on all of these initiatives in the pillars to really expand utilization at every routine use site.

Unknown speaker -- BTIG -- Analyst

Perfect. That's great color. Thanks for that. And then, maybe just switching gears, just on the reimbursement fund, could you share if OGM appeared on the Medicare or clinical lab fee schedule as planned? And then, just any other updated timing we should be aware of on the LCD front.

Thanks.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yeah. So, you know, certainly on time, January 1st, 2025, it was -- it's effective. I think that that listing was made public in November of 2024. And the rate was consistent with what CMS initially priced it at.

What I would say is that that rate, it's around $1,300. That rate is consistent with some proprietary laboratory analyte, or PLA codes, for OGM. It's also consistent with PLA codes for constitutional genetic disorders. There are, however, PLA codes for hematologic malignancies that are priced higher.

And so, I think that -- I would say that, you know, the effectiveness that happened on January 1st this year is consistent with what preliminary pricing was at. I do believe that -- I don't want to set an expectation, but, you know, it's not unreasonable to believe that there could be a reconsideration of the price over time. And it's my understanding that some customers are seeking that reconsideration. We have to be cognizant of the fact that these processes, which are happening at CMS, which is part of the Human Health Services agency, are probably undergoing some transition.

So, we don't know the expediency with which these things will happen here in 2025. But I would say, everything happened as expected, and there is the potential that pricing might increase over time.

Unknown speaker -- BTIG -- Analyst

OK, great. If I could just squeeze in one more, and then I'll hop back in queue. I think you highlighted seeing in solid tumors, rare disease, and a few other applications among your users. Just any particular areas of strength that you're seeing in the routine user group? I think you alluded to some menu expansion as well.

So, could you just touch on what other applications you're thinking about in the pipeline there? Thanks.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Yeah, I would say so. The answer to your question unequivocally is hematologic malignancies. This is the primary application that sites are adopting OGM for. And, you know, we've narrowed our target geographies somewhat.

But across the globe within these target geographies, that is the primary pool from customers. And the reason for it is that they are reliant upon karyotyping, which has been around for 50 years, and fluorescence in situ hybridization, or FISH, which is a targeted methodology and simply leaves too much information on the table for them to reliably conduct their research and manage the cases that they're looking at. And so, optical genome mapping is now really a proven alternative to these techniques. And we are aware of several sites which have completely walked away from karyotyping and FISH, and rely entirely on optical genome mapping.

So, that is for sure the primary driver of adoption. A very healthy second is constitutional genetic disorders. And we saw a beautiful paper published recently by the Greenwood Genetic Center, which is really the leading site for many novel technologies and applications in genetic analysis for constitutional genetic disorders. And their publication was on neural tube defects, so-called NTDs.

And what it really highlighted was that optical genome mapping could just go very far beyond what existing cytogenetic methods could do in terms of identifying likely drivers of that defect. But not only going beyond it, but also complementing very nicely what sequencing does. And so, we see this adoption for constitutional genetic disorders as, you know, a good second place. Solid tumor is emerging, but, you know, solid tumor, as you know, is a substantial -- you know, creates a substantial flow of samples.

And so, it's a big economic opportunity for us. And cell and gene therapy is also just getting started, but pharmaceutical companies are using optical genome mapping to analyze their modified cells or stem cells to look at things like genome integrity and on and off target effects that are introduced by the gene editing apparatus. And so, we have a good list of indications or applications that customers would adopt for. We clearly know which is the primary one.

And then, menu expansion exists within each of these groups. So, think about cell and gene therapy. You've got stem cells. You've got CRISPR-Cas9.

You've got CAR-T. Within constitutional genetic disorders, we talked about the birth defects. But you have intellectual disability, developmental delay, and a variety of applications there, which users can validate one after the other. And then, across hematological malignancies, you've got leukemias, lymphomas, myelomas, and then solid tumors, lung, colon, breast, prostate, etc.

So, that's how we see menu expansion progressing within each of these application areas.

Unknown speaker -- BTIG -- Analyst

OK, perfect. Thanks for taking the questions there.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Thank you, Vivian.

Operator

Thank you. And that does conclude today's Q&A session. I would like to go ahead and turn the call back over to Erik for closing remarks. Please go ahead.

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

OK, well, thank you, Lisa, and thank you to everyone who joined and for following along. And we look forward to updating you in the not too distant future on our progress in the first quarter here in 2025. So, thank you very much.

Operator

This ends today's conference call. Thank you for joining. [Operator signoff]

Duration: 0 minutes

Call participants:

David Holmes -- Investor Relations

Robert Erik Holmlin -- President, Chief Executive Officer, and Director

Sung Ji Nam -- Analyst

Erik Holmlin -- President, Chief Executive Officer, and Director

Michael Okunewitch -- Maxim Group -- Analyst

Unknown speaker -- BTIG -- Analyst

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