Bionano Genomics Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 5, 2024

There are 8 speakers on the call.

Operator

Good day, and welcome to the BioNano 4th Quarter and Full Year 2023 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.

Speaker 1

Thank you, and good afternoon, everyone. Welcome to the BioNano 4th quarter and full year 2023 financial results conference call. Leading the call today is Doctor. Eric Holman, CEO of Bionano. He is joined by Gulsen Kama, CFO of Bionano.

Speaker 1

After market close today, Bionano issued a press release announcing its financial results for the Q4 and full year 2023. A copy of the release can be found on the Investor Relations page of the company's website. I would like to remind everyone that certain statements made during the conference call are forward looking, including statements about Bionano's strategic and commercialization plans, sales pipeline, future fundraising activities and prospects, cash runway, expected cost savings initiatives and the estimated impact on annual operating expenses, the timing of expected benefits in such initiatives, expected reductions in headcount, anticipated benefits or improvements to the Stratus, Saphyr and ionic purification system and their advantages over current technologies, goals and anticipated milestones for 2024 and achievements of the Elevate Growth strategy, our anticipated compound annual growth rate, the size of our ability to access our estimated target markets, the anticipated benefits of recent acquisitions, expectations regarding the timing and the content study results and the anticipated benefits of these studies, in driving adoption of the Strata system, Saphyr system and the IONIQ purification system. Such forward looking statements are based on current expectations and there can be no assurances that the results contemplated in these statements will be realized.

Speaker 1

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 reported reports filing with the SEC. These forward looking statements are based on information available to Bionano today, and the company assumes no obligation to update statements as circumstances change. In addition, to supplement Bionano's financial results reported in accordance with the U. S. Generally Accepted Accounting Principles or GAAP, the company is reporting non GAAP operating expense.

Speaker 1

This non GAAP financial measure is 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 and has no standardized meaning prescribed by GAAP and is not prepared under any comprehensive set of accounting rules or principles. A description of non GAAP operating expense and reconciliation of non GAAP operating expense to GAAP operating expense 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. An audio recording and webcast replay for today's conference call will be available online on the Relations page of the company's website. With that, I will turn the call over to Eric.

Speaker 2

Thanks, David. Good afternoon, everyone, and thank you for joining us today. Today's call is an important one for Bionano. We want to cover a lot of ground, starting with an update on Q4 and the full year 2023. And then we want to cover the 2024 outlook, including important progress we are making to address our capital structure and cash burn.

Speaker 2

I would like to first turn the call over to Ghul san to cover the financial results for Q4 and full year 2023. Ghul san?

Speaker 3

Thanks, Eric. Consistent with our pre announcement in January, Q4 revenues were $10,700,000 which is up 30% versus Q4 2022. 2023 revenue totaled $36,100,000 which reflects an increase of 30% over 2022 revenues. Our installed base of optical genome mapping systems grew by 25 from the 3rd to the Q4 of 2023 for a total of 326 on December 31, 2023, which reflects a 36% increase from year end 2022. We sold 7,980 float sales in the quarter, which reflects 67% growth over Q4 2022.

Speaker 3

For the full year, we saw 72% growth in the number of flow cells sold from 2022 to 2023 with a total of 26,444. This growth is important to note as we believe it indicates higher consumables utilization given that consumables growth is outpacing installed base growth by a factor of 2. We expect utilization to increase even more as the higher throughput Strata system becomes a larger percentage of our total installed base. In October 2023, we completed an $80,000,000 financing of convertible notes and warrants and we ended the 4th quarter with $102,300,000 in cash, cash equivalents and available wholesale securities, of which $35,500,000 was subject to some restrictions. On February 28, 2024, we announced an important restructuring of the convertible notes, which lowered the minimum available liquidity covenant from $50,000,000 to $25,000,000 lowered the restricted cash covenant from $35,000,000 to $25,000,000 which can be further reduced as remaining principal is retired, canceled the March partial redemption payment and delayed the April partial redemption payment to April 20 and redeemed $27,700,000 in principal leaving the outstanding debt at $24,300,000 This restructuring effectively unlocked $30,000,000 with the potential to free up an additional $25,000,000 as further principal is retired.

Speaker 3

Regarding operating expense, GAAP gross margin for the 4th quarter of 2023 was 23%, which is slightly higher than the 22% GAAP gross margin reported for the Q4 of 2022. Full year 2023 total gross margin was 26%, up from 21% in full year 2022. 4th quarter 2023 GAAP operating expense was $27,400,000 compared to $39,300,000 in the Q4 of 2022. The year over year decrease was primarily due to a decrease in the fair value of contingent consideration of Purigen milestones and reduced headcount related expense, partly attributed to the cost savings initiatives outlined in our Q2 2023 and Q3 2023 earnings releases. 4th quarter 2023 non GAAP operating expense was $27,300,000 compared to $30,600,000 in the Q4 of 2022.

Speaker 3

Full year 2023 GAAP operating expense was $224,800,000 and non GAAP operating expense was $127,300,000 Full year 2023 non GAAP operating expense excludes a one time impairment charge of $77,300,000 $14,500,000 in stock based compensation and $7,200,000 in amortization of intangibles, partially offset by a $1,500,000 in reductions of contingency based obligations. Since joining ViaNano, I have been focused on driving increased discipline to our spending, while we work to extend our cash runway. In October 2023, we announced the cost savings initiative that we believe together with reductions that began in May, we'll save approximately $33,000,000 annually, including a reduction in headcount of approximately 83 employees and reductions in discretionary spending on various projects. Some of those savings were evident in our 4th quarter OpEx, but for timing of employee expenses coming off the books, we expect to see the full benefit of the reductions starting in the Q1 of 2024. Today, Eric and I are announcing that we're implementing new plans that will further reduce expenses.

Speaker 3

Streamlining operations is possible because of the product launches behind us and addresses the current equity capital environment for tools and diagnostics companies, which is requiring companies to become much more efficient with resources and to reduce cash burn. With this 2024 initiative, our goal will be reducing annualized operating expense by another estimated $35,000,000 to $40,000,000 including a potential reduction in headcount by an additional 110 to 125 employees, bringing the total number of employees down to approximately 200 from approximately 324 today. Overall, since May 2023, through the completion of the initiatives announced today, we aim to have reduced headcount by approximately 200 people and reduced annualized operating expenses by about $65,000,000 to $75,000,000 We expect the savings initiatives we're announcing today to have associated costs. We will provide that information as appropriate once we have more completely finalized the costs associated with these plans. As we streamline our operating structure, we believe we're cementing the path forward now.

Speaker 3

Our core product development is mostly completed and we're targeting segments of the genome analysis market where we believe we face no direct competition seeking to replace the classical cytogenetic methods with a single assay in to genetic methods with a single assay in contrast to the sequencing and spatial genomics markets, which have become incredibly crowded. With that, I will turn the call back to Eric to discuss our 2024 anticipated business plan before we take your questions. Eric?

Speaker 2

Thanks, Khozan. 2023 was one of Bionano's most successful years ever with solid revenue growth and achievement of all our publicly stated Elevate milestones. Despite the challenging backdrop from macroeconomic headwinds facing the industry overall, we believe 2023 set the stage for a bright future for OGM and the impact our products can make in healthcare. We believe the evidence is clear, ELEVATE is working. We saw a substantial increase in OGM publications in 2023 with over 5,000 clinical genomes published and the highest recorded quarter to date with 88 publications in the Q4 of 2023.

Speaker 2

OGM studies including our own clinical studies program have now moved beyond showing concordance to focusing on demonstrations of the incremental value of OGM over classical methods. Our product development teams brought 2 new transformative products to the market, which are key to the end to end solution for OGM via software and the Stratus system. Via software makes the visualization, interpretation and reporting of OGM data incredibly fast, automated and easy to digest. It also enables analysis of chromosomal microarray and next generation sequencing data together with OGM, which is a feature that is totally unique in the market. The Stratus system increases the throughput of OGM data generation by as much as 4 fold compared to the Saphyr system and we have a roadmap to further increase that throughput over time.

Speaker 2

Stratus was released in an early access program in Q4 and demand exceeded our planned supply of 10 systems. We ended up with orders for 11 early access Stratus systems, 70% of which went to new customers. We're excited to introduce Stratus Live to the market at the upcoming ACMG meeting in Toronto, March 13 through 16, including at a pre conference scientific event hosted by Bionano on March 12, where Stratus users will present their progress and at a reception for conference attendees on March 13. The next component of the streamlined end to end solution to come out is isotachopheresis or ITP for OGM on the IONIQ system, which is currently in pre commercial evaluation in the field now. And we expect ITP for OGM to be released commercially in the second half of this year.

Speaker 2

Looking ahead to executing Elevate in 2024 with a further streamlined operating structure, we're aiming to limit the impact of downsizing on revenue growth in the core OGM products. As part of that streamlining, however, we have made the difficult decision to phase out some of our clinical services products that we sell directly to physicians, namely our First Step and Next Step DX products and our Fragile X test, which are legacy non OGM tests. In 2023, these products generated around $7,000,000 of the overall 36 $100,000 in revenues. Therefore, after taking into account discontinued products, we are guiding full year 2024 revenues to be in the range of $37,000,000 to $41,000,000 and Q1 2024 revenues to be between $8,250,000 $8,750,000 We expect to install between 80,100 new optical genome mapping systems in 2024, but we think the net increase to the installed base may reflect some Saphyr to Stratus upgrades. So we expect the OGM installed base by the end of 2024 to be in the range of 381 to 401 systems.

Speaker 2

Regarding next steps on the path to OGM reimbursement, Bionano Labs submitted the dossier for local coverage determination coverage policy for heme malignancies from MolDX Palmetto in the Q4 of 2023 and the application was accepted, which is the first step in the process. Bionano Labs is working with other OGM users to seek local coverage determinations from other Medicare Administrative Contractors or MACs in the U. S. In the meantime, customers continue to be successful in obtaining and using PLA codes to get reimbursement for OGM applications. We believe a Category 1 CPT code is a more general solution to reimbursement coding for OGM in the U.

Speaker 2

S. According to the AMA website, an application for a Category 1 CPT code for OGM in the 2024 cycle has been submitted. The process is confidential and we are not able to confirm if it is one of our users in the U. S. As the applicant's name is not public information.

Speaker 2

Widespread utilization of OGM is one criterion that the AMA will use in the evaluation of a CPT code application. And we believe it will be more meaningful if OGM users are able to directly speak to the utility of the workflow. The CPT code application process unfolds over the next few months, and so we're hopeful of a good outcome towards the end of the Q2 2024. In 2024, our clinical studies programs will focus mainly on heme malignancies in an effort to support the medical guidelines and reimbursement decisions connected to this application for OGM going forward. We will also maintain efforts to address regulatory requirements where they represent opportunities to clear the path for adoption.

Speaker 2

In closing, I want to emphasize that while we are facing challenges from the situation related to Equity Capital Markets, our core business is healthy. Reducing expenses is a difficult but important step in addressing our financing overhang as we continue our mission to transform the way the world sees the genome. With that, operator, we are ready to take questions.

Operator

Our first question comes from Sung Ji Nam with Scotiabank. Your line is now open.

Speaker 4

Hi, thanks for taking the questions. So just a clarification to start off, for the $7,000,000 the revenue that's being discontinued from the Next Step and First Step and Fragile X, Are they all coming from the service revenue segment? And then would you be able to comment on kind of what the growth rate has been for that business over the years?

Speaker 2

Yes. Those are coming from what would be services and they've been growing a little bit, but our expectations as we were looking ahead to 2024 before making the decision to discontinue them was that they would be mostly flat.

Speaker 4

Got you. Okay. And then Eric, great to hear kind of your focus on he malignancies this year. But could you give us kind of an update in terms of all the clinical studies underway preclinical post I'm sorry, prenatal, postnatal team and also solid tumor and what the statuses are and kind of what the next steps are for all of them?

Speaker 2

Yes, sure. So, we've really made tremendous progress across all areas, perhaps with the exception of solid tumor, although we have the study, which has been IRB approved, and we're really waiting to just actually have really more bandwidth to spend time on that particular study. In both prenatal and postnatal, we had landmark publications that came out over the course of the year in 2023, really demonstrating the concordance with traditional methods and beginning to show some of the incremental benefits in diagnostic yield, especially for the postnatal study. And so we feel like we've created a really solid momentum for those studies and it's going to be fine to let them sort of filter into the market and for people to digest those data. There's really large data sets that show the value of optical genome mapping as a replacement for traditional methods.

Speaker 2

And then hematologic malignancy study has also progressed significant publications including peer reviewed publications over the course of 2023. And our focus going forward there will be really to continue to pursue all of the endpoints that we intend to measure, which include the incremental benefits of optical genome mapping over traditional methods. We've seen a little bit of that in some of the early studies and early publications, but we're going to continue to dig deeply into that. And then we also want to be able to show changes in how cases are managed as a result of the information that comes out of these studies as well as a variety of health economic benefits. And so, some of those endpoints for prenatal and postnatal might be a little bit delayed, and we'll get them for heme first.

Speaker 2

But I think that the clinical trials program had developed such incredible momentum that a lot of the work will continue independently of our efforts and that will allow us to focus the resources that we have on heat.

Speaker 4

Got you. Great. That's super helpful. And then just the last one for Golston. Could you maybe talk about the your expectations for gross margin cadence for this year?

Speaker 4

Good to see continuous improvement there throughout last year. But I was wondering given the full commercial launch of Stratus as well as the discontinuation of certain product lines, should we anticipate some disruption on the margin side at least for the early part of the year?

Speaker 3

I don't think so. If anything, I think some of the cost reductions that we announced will actually have an impact even on cost of revenues. So just because of that, I think there will be an improvement.

Speaker 4

Got it. Great. Thank you so much.

Speaker 2

Thank you. Thank you, Sunseeker.

Operator

One moment for our next question. Our next question comes from Mark Massaro with BTIG. Your line is now open.

Speaker 5

Hey guys. Thank you for the questions and congrats on a strong 2023. Maybe just starting with the headcount reductions. So it looks like you're talking about a potential reduction number, I guess. Have you I mean, you obviously provided the number.

Speaker 5

So can you just give us a sense for what would move that from potential to moving forward and how should we think about the timing? And then related to that, I know Eric, you don't want to impact revenue generating activities, But that is a large number of folks. So maybe just walk us through whether or not you think you're able to withhold cuts to commercial activities?

Speaker 2

Sure. So I think with regard to the language that we're using, I think a fair takeaway is that we're seeking to come from about 324, which is the headcount that we're at now down to 200. And our experience when we did reductions in the Q4 was that for a variety of reasons, a few people here and there had to be taken in and moved out of the plan. So we want to leave some room around the 200, but that's certainly the target that we're aiming for. So that would suggest a reduction right around 125 people.

Speaker 2

And as has been pointed out, as we discussed these steps with our incredible employees and as you can imagine, it's such a difficult decision to make to reduce these costs. Those that sort of magnitude exceeds a third of the company. And so essentially all areas of the company will be impacted. And one of the reasons that we decided to discontinue the services products was that there are a fair number of people associated with generating those revenues. And so that allows us to meet part of that headcount target in a single move.

Speaker 2

The other reason is that as important as that product flow is and the samples coming in the door and they provide some benefit to the advancement of OGM overall. They're not really core and so a key driver as we think about going forward is that we really want to be deeply focused on optical genome mapping and have all of our management resources dedicated to that. So that helps with some of the numbers. And then in order to address the remaining, we recognize that we've gone through some significant product developments via software is in the market, The Stratus system is in the market. And so the incredible people who have helped us get to this point, We don't need as many of them going forward.

Speaker 2

So that's a part of the transition. And then commercially, we do have some impact across sales and marketing. And the way that we're balancing that is to really leverage where we have distribution partners and third parties that support our products in the market. We're really going to lean on them and they're going to have to deliver. And so what you'll see is that maybe we're not going to be as ambitious about growing our commercial footprint globally and internationally across APAC and Rest of World, and we'll maintain our very successful focus in Europe and United States and Canada.

Speaker 2

So it's we are certainly going to impact headcount there, but we want to keep the momentum in place that we've built so far.

Speaker 5

Okay. And then maybe a clarification on the installed base and the guidance. It looks like you're expecting a range of 80 to 100 systems this year. You did indicate you expect some conversions from Saphyr to Stratus. Is it right that if I just do the math, you might have, let's see, an increase of 65 systems overall, but the delta between the 65 and the 90 at the midpoint would be the conversions.

Speaker 5

I mean, is that based on is that math right? And then is that based on conversations you're having with customers? And then maybe lastly, can you talk about mix between capital reagent rental, how you think that might play out this year?

Speaker 2

Sure. Yes, I think that your sort of math is correct there. And we feel confident about this 80 to 100 new installs. And there's the potential to get past that, but we want to make sure that we deliver against what we're signing up for here. And these conversions or upgrades, if you will, We have some visibility into that, but I think aside from the early access program, we're only about 45 days into the full commercial release of Stratus.

Speaker 2

And so the information that we're getting is fairly new. And so the 25 upgrades is an estimate. And so we'll just have to see how things play out going forward.

Speaker 5

Okay. And last question for me is, it's nice to see you submit the dossier to Palmetto Moldex. Is it your expectation that 2024 is a year obviously for them to review it, maybe come up with a draft decision? Do you think that might hit by year end and then maybe go final next year? Maybe just help us think about how you're thinking about timing?

Speaker 2

Yes. So I can share some additional information that we've learned as part of the process, kind of pre submission and then subsequently is that there needs to be a determination as to whether this application is ultimately treated as a request for a completely new coverage policy or if it can be attached to any of the existing ones. And we're fairly certain that it's likely to be a new policy. And so for our own thinking and our own planning purposes, we treat it that way. And I think it's reasonable to expect that it could take all of 2024 for a new draft coverage policy to come out.

Speaker 2

So the earliest that we would see it, I think it's safe to say that we would see the draft policy early 2025 and with the potential for it to become final in 2025. Maybe that maybe the folks working on it beat that, but I think that's a safe estimate.

Speaker 5

Yes, that makes sense. All right, thanks for all the time.

Speaker 2

Thank you, Mark.

Operator

Thank you. Our next question comes from Jeff Cohen with Ladenburg Thalmann. Your line is now

Speaker 6

open. Good afternoon. Thanks for taking our questions. I wanted to follow-up on Mark's previous question. Could you comment a little bit on the count one CPT code and the AMA from what you know currently and how might that play out over 24?

Speaker 6

And if that plays out well, then when would that take effect?

Speaker 2

Sure. Thanks, Jeff. So I think in contrast to prior years where Bionano has led the process to apply for the CPT code, I think what we learned in technology, it's difficult for us to really provide the information. And so we were pleased to see that an application for a CPT code has been made this year. And what we know with certainty is that we were not the applicant.

Speaker 2

And so it's reasonable to conclude that the applicant is a user. And as we sort of indicated in our prepared remarks, we're not able to sort of confirm their identity because it's a confidential process. Having said that, the process is standardized and plays out over the next 2 or 3 months. And so I think that what we're likely to see is the application proceeding and the applicants will know sometime in late May, early June where it stands. And then us as observers from the outside, we will know if the code is advanced into the agenda of the final meetings, which take place in June, that agenda is published shortly before the meeting.

Speaker 2

So I think we'll all be watching very closely over the next couple of months to see how the situation unfolds.

Speaker 6

Okay, got it. That's helpful. Could you talk a little bit about the Stratus placements? I know it's a real action plan, but you had mentioned 7 out of 10 were new customers. Can you walk us through perhaps the methodology or the thinking there as far as those customers wanting a higher throughput system and perhaps some flavor as far as what types of accounts they were?

Speaker 2

Yes. Across the board, our accounts and I think that this has been a consistent pattern now for a while and we should start emphasizing it more. But these are all either academic medical centers like hospitals or regional reference labs or commercial labs. And we also have systems going to pharmaceutical companies. So what we don't see anymore, and I think that this is a really important transition that we've undergone, We don't see the academic research centers who are buying optical genome mapping to create the next reference genome for this species or that species.

Speaker 2

There's a little bit of genetic and genomic mechanistic work going on, but just about us, substantially all of our adoption is really in our target markets, routine use and hematologic malignancy research, constitutional genetic disease research and then applications in cell and gene therapy. So super pleased about that. And then when we look at the Stratus system and the folks who have raised their hands, without a doubt, they see it as the thing that they've been waiting for, that provides them new higher throughput. There are also other characteristics of the Stratus system that make it attractive to users, which include really a lot of flexibility coming to introducing samples into the system and generating data. For example, the Stratus system can run 12 samples at a time, but also accommodate up to 3 additional samples in a just in time sort of fashion where you can jump the queue and get ahead and run urgent samples.

Speaker 2

And so the flexibility in the workflow coupled with the higher throughput is something that labs are finding very interesting and very attractive. And something else that we're seeing is that accounts that had been in our pipeline and in the process of purchasing optical genome mapping are making the shift from Saphyr to Stratus. And I don't know if Mark is still on, but he had also asked about the kind of distribution of rentals to capital purchases. And for a while now, we've seen a very rough fifty-fifty distribution, but we're actually seeing a little bit more of purchases with Stratus and that's encouraging.

Speaker 6

That's helpful. And then finally for us for Golson, in particular, when you talk about the OpEx reductions for 24, if we do some quick math off the 23 numbers, less the impairment and what you're leaning toward. We're getting, call it, about $115,000,000 to $120,000,000 for full year 'twenty four. And could you maybe comment on that? And then perhaps give us a little insight into how you see that breaking down between R and D and SG and A?

Speaker 3

Yes. So in terms of 2024 impact specifically, not the annualized savings numbers, which is what we announced. It will take some time to implement the savings initiatives. So we'll most likely see a partial year impact as a result of the most recent announced ones. The ones that we announced in October should be in full effect by now.

Speaker 3

So the number that you mentioned, I would at least divide by 2, I guess, in terms of the impact in 2024 specifically. And I'm sorry, what was the second part of your question?

Speaker 6

Just if you could give us a sense of the ramifications on the orange and orange and orange. Yes.

Speaker 3

I think as Eric mentioned, it's both new product development with Stratus already rolled out, but it's also on the commercial side. So for now, again, I can get back to you, but I would expect equal foot almost.

Speaker 6

Got

Speaker 7

it.

Speaker 6

Okay. That's super helpful. Thanks for all the questions. Congrats on the quarter.

Speaker 2

Thank you.

Operator

Thank you. Our next question comes from Jason McCarthy with Maxim Group.

Speaker 1

Your line is now open.

Speaker 7

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

Speaker 2

Hi, Michael.

Speaker 7

So, as I get I guess, just the first question, I just want to get a point of clarification. Is the full year 'twenty four revenue guidance fully factoring in the removal of those legacy tests? I'm trying to understand if it's appropriate to consider the core growth rate there to be like 27% to 40%.

Speaker 2

Yes, it is fully factoring in the reduction or removal of those revenues, we're probably going to see a little bit of them in the Q1. So I think at the high end of that range, we're really aiming to get to 30% growth in the core.

Operator

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Eric Holman for closing remarks.

Speaker 2

Okay. Thank you, Daniel. And I want to thank everybody for joining in the call. And we look forward to updating you shortly on our progress here in the Q1 of 2024. Thank you very much.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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Bionano Genomics Q4 2023
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