Bionano Genomics, Inc. (BNGO) on Q1 2021 Results - Earnings Call Transcript
Operator: Good day and welcome to the Bionano Genomics First Quarter 2021 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Amy Conrad from Investor Relations. Please go ahead.
Amy Conrad: Thank you, Latif. And good afternoon, everyone. Welcome to the Bionano Genomics first quarter 2021 financial results conference call. Leading the call today is Dr. Erik Holmlin, CEO of Bionano. He is joined by Chris Stewart, CFO of Bionano, and Alka Chaubey, CMO of Bionano. After market close today, Bionano issued a press release announcing its financial results for the first quarter of 2021. A copy of the release can be found on the Investor Relations page of the company's website.
Erik Holmlin: Thank you, Amy. And good afternoon, everyone. Let me begin by saying that 2021 is off to a solid start for Bionano, and we're thrilled with our progress during this first quarter. We ended 2020 with a strong fourth quarter, and that momentum has really continued into this first quarter of 2021 where we had record numbers of flow cells sold, services samples analyzed and Saphyr systems installed. There are now more Saphyr systems in service than ever before. That's really important because it means our customers are able to analyze more and more genomes. And with the improvements in throughput and costs of operation that we've introduced, they're running larger and larger studies, which in turn means there'll be more data in the field. And those data really tell the story of the value of optical genome mapping. And what we're seeing is that the quality and number of presentations and publications featuring this optical genome mapping data is continuing to increase. And I can't really think of a better illustration of that progress than our next generation cytogenomics symposium that some of you may have followed. It was originated and organized by Dr. Alka Chaubey, our CMO, and it featured 32 customers presenting breakthroughs that were enabled by optical genome mapping across basic research, clinical research, including applications in COVID during a total of 33 presentations over the course of five days in January of this year.
Alka Chaubey :
Erik Holmlin : Thank you, Alka. Much of the progress we are making as possible because of the outstanding team we are building and the strength of our balance sheet, which together enable us to invest in and advance all areas of the business without the capital constraints we once faced. With our elevated profile of bringing the next disruptive technology to healthcare, we will have the opportunity to continue adding transformational talent to the team to further accelerate our progress. And I'm inviting you to stay tuned for more progress in this area of human capital.
Christopher Stewart : Thanks, Erik. And hello everybody. Revenue in q1 was approximately $3.2 million, up 179% from the $1.1 million we reported in the same period of 2020. Year-on-year, revenue was up in all geographies and across both product and service revenue. The increase in global product sales was driven by increased demand for our reagent rental program and consumables, while the increase in service revenue was primarily driven by sales from our Lineagen subsidiary. Our gross margins came in at 33%, up 8% from the same period last year, due mainly to a shift in our product mix towards higher margin consumables and services. First quarter operating expenses was $12.2 million, an increase of $2.2 million over the same period in 2020. This increase was primarily due to increased headcount related and material and supply expense. Finally, as of March 31, 2021, our cash balance was $362 million, derived from the raise of $337 million in two underwritten public offerings, sales on our AGM facility, and the exercise of outstanding warrants for common stock, driven by the increase in our share price. As has been discussed, our objectives for 2021 center on clearing additional barriers to widespread adoption through the execution of our clinical studies, continuing to expand on the number of published studies showcasing the power of Saphyr, and making progress on our next generation high throughput Saphyr instrument. We will also continue to build both our sales and marketing and our R&D teams prudently through the year. This is a very exciting time for Bionano. We are well capitalized and sharply focused on execution. We look forward on updating you on our progress through the year. And again, as Amy mentioned up front, we want to remind you again that our annual meeting is coming up on June 10. And we ask you to please vote your shares as soon as possible. With that, I will turn the call back to Erik to discuss upcoming milestones for the year, then we'll open it up for Q&A. Erik?
Erik Holmlin : Thanks, Chris. Outstanding update. In summary, the first quarter of 2021 continued the momentum we saw in the second half of 2020. We're progressing nicely against our main goals of working toward global adoption of Saphyr through increased sales, increased publication of Saphyr data, initiation of more clinical studies and broadening the scope of the technology. Here you can see more anticipated milestones for the remainder of 2021. In the next year, and several years, we believe that optical genome mapping has the potential to become the standard of care. Right now, Saphyr is a research-use only tool and we're doing the right studies to demonstrate its utility. With all our programs, we're hopeful that optical genome mapping could be considered a standard technology in prenatal and postnatal analysis, hem malignancies as well as solid tumors. We're making great progress along these goals, and are hoping to grow the installed base to a level of about 150 Saphyr systems by the end of this year, which represents a key milestone around adoption. And with that, we are ready to take questions. So operator?
Operator: . Our first question comes from the line of Kevin DeGeeter of Oppenheimer.
Kevin DeGeeter: Thanks for the update. Very positive all around. First of all, a few housekeeping. Can you just give us a breakdown of reagent rental versus capital purchase on the 11 placements in the quarter? And just in general, what you're seeing in the appetite, potential new placements in terms of reagent rental versus capital purchase?
Erik Holmlin: Kevin, we're not breaking that out. What I would say is that the majority of the systems that went out were in the reagent rental program. The reason we're not breaking it out is that it's still sort of finding its level. And so, I don't want that to set any particular precedent. The other piece of information that I think would probably be helpful to you is that if you look at the revenues attributed to instruments, what we can say is that those sales were all right around the list price for the system. So, I think with that information, you would probably be able to get pretty close to what those numbers are.
Kevin DeGeeter: Appreciate the detailed update on reimbursement strategy. Makes a lot of sense. So, can you provide us a little bit more granularity in terms of – you mentioned the three sites, I believe, in postnatal have been identified, kind of which sites. And as we think about, I think you called out 1,000 patients as kind of target data set size, is that per side or kind of collectively across or there is three in each vertical?
Erik Holmlin: There are fundamentally five studies organized in four pillars and those four pillars are prenatal, postnatal, hematologic malignancies, and solid tumors. The hematologic malignancies has a leukemia arm to it and a lymphoma arm. So, that's your five. And our plan is to have 1,000 patients in each of those five areas spread across the multiple sites that are participating. As Alka said, at least three per site – per propeller.
Kevin DeGeeter: Lastly, following up on that, you called out the timeline to potentially begin generating data, I think, in pre and postnatal. Any early thoughts just to kind of how long that total data collection time may take to be able to reach that 1,000 patient threshold in at least kind of the first those five verticals?
Erik Holmlin: What we think is that we should be able to get a substantial fraction of the postnatal samples data from them collected and analyzed. And so, I want to say somewhere in the neighborhood of 35% to 50% of those done by the end of the year. And we expect that we'll be able to generate presentations or that the sites will be able to generate presentations and publications to give some interim readouts based on those numbers of patients. One of the reasons that we have set this goal to get these numbers as high as we have is that we believe that that's what it's going to take to influence these guidelines. And to be perfectly frank with you, we were only dreaming of having the opportunity to do that, right, in some period of time because it's a lot of patients, it's a lot of time, it's a lot of sites, it's a lot of Saphyr systems. And the capital that we raised in the first quarter of this year has made that possible, and so has really accelerated these timelines. But there's going to be a substantial amount of data collected in postnatal this year, and we're going to get a glimpse of those results.
Kevin DeGeeter: Last clarification on that and then I'll get back in the queue. Will the samples analyzed in Saphyr in those various clinical trials run through the P&L line as recognized revenue? Or will those be development expenses with no revenue associated with samples and consumables associated with the site?
Erik Holmlin: It's a mix. It kind of depends on the relationship that we have with the site. There are some sites where there are sponsored research activities. There are other sites that are existing users and they are purchasing reagents. So, you're going to see some of the expenses hitting the R&D line. And in other areas, there are going to be revenue generating studies.
Operator: Our next question comes from Jeffrey Cohen of Ladenburg Thalmann.
Destiny Hance: This is actually Destiny on for Jeff. Just quickly, I'm curious to know if there any accounts that do the rental program that actually end up purchasing the Saphyr outright?
Christopher Stewart: Yeah. We're starting to see that. So, the reagent rental program is just over a year old. And we have seen at least one customer convert to a sale. And we expect that some percentage of the reagent rental customers will convert to sales over time, which is another reason why we decided not to split out sales versus reagent rentals because they end up crossing over at times.
Destiny Hance: Just on gross margins, how should we be thinking about them throughout 2021, especially due to higher levels of utilization and the expanded installed base?
Christopher Stewart: We expect them to marginally improve through the year as we grow revenue, but not materially, right? We will materially grow our gross margins beyond this year as we really ramp up consumables as a percentage of our total revenue. Right now, we have a pretty decent mix of instrument sales, which are lower margin, with consumables which are higher margin, and that mix isn't going to change too dramatically this year.
Destiny Hance: Perhaps that leads me to my next question. Are you able to just at a high level discuss the breakdown geographically of the current installed base?
Erik Holmlin: What I would say is that's distributed about 50% US, 50% ex-US. And Europe has probably got a little bit more than half of the ex-US portion. And Europe has really been a significant contributor to the business lately. And so, we would expect them to continue outpacing some of the other geographies. And I think that that's a pretty industry norm distribution.
Destiny Hance: Yes, I would agree. And then, you've had some adoption by very large medical centers, especially O-US. So, I'm just curious if you could discuss or remind us about the international opportunity and how this adoption could help drive that going forward?
Erik Holmlin: I think that when you look across the progress that we're making in the business, it's really global. And this is an advanced method for research applications. And of course, as you know, labs are advancing the capabilities and implementing it in a variety of ways. And because of that, the adoption tends to be centered in countries that are able to invest in newer technologies, so more developed areas, but the incredible awareness of optical genome mapping is on the map, everywhere around the globe, and we're hearing about it everywhere – from everywhere. We're receiving inquiries about it from everywhere. And so, what our view is that we will continue to see growth and adoption in the traditional developed markets, such as the United States, North America, China, more broadly in the Asia-Pacific region where we already have a good installed base, Western Europe, a little bit into Eastern Europe. But there are areas such as India that we have systems installed. And let me be very clear, India is reaching out. And so, we fully expect this to be a global platform and that our opportunity is worldwide.
Operator: Our next question comes from Jason McCarthy of Maxim Group.
Michael Okunewitch: It's Michael Okunewitch on the line for Jason. So you guys really have done a great job building a really strong balance sheet here. You have $360 million in the bank. And that's essentially several years of runway, gives you a lot of breathing room. What I want to know is, how are you guys planning to invest that money to drive further adoption of Saphyr? You mentioned those five studies that you've been able to accelerate. Should we expect some additional studies to initiate and describe what other ways you're using your balance sheet to drive the story forward?
Christopher Stewart: One of the main things is driving these clinical studies in 2021. We will also continue to build out our sales and marketing team and our customer service team. And we're also investing in our next gen product. That's the focus for 2021. Beyond that, we will continue to develop assays for more indications and more sample types and things like that to just continue to expand the market for Saphyr. We potentially would look at strategic opportunities, if those strategic opportunities can accelerate the path for Saphyr adoption, but nothing on the near-term horizon.
Michael Okunewitch: I'd actually like to ask you about kind of the target profile for the next generation Saphyr. And really how we should think of this? Is this more so a premium higher throughput version of Saphyr? Or is it a successor and really the next step in the Saphyr story?
Erik Holmlin: It's more like the former, although Saphyr is premium and its next generation counterpart will be just as premium. But it will be much higher throughput. And so, what we anticipate is that the current Saphyr system would be a really terrific solution for low to mid volume labs and higher volume labs, which are currently adopting Saphyr for a portion of their menu, will need something with substantially higher throughput. And so, that's what that next generation system is intended to serve. And we've talked about that – our goal – historically, what we've done is to – through the end of last year with the release of capabilities to bring Saphyr throughput to 96 samples per week or 5,000 samples per year, that represented a 14 fold increase over where Saphyr throughput was at launch in early 2017. And what we have said is that the next generation, through a couple of steps, will bring another 14-fold increase and that that would be completed by the end of 2023. And so, it really is the same kind of amazing capabilities. Obviously, with certain updates and revisions that will also be backward – many of which will be backward compatible to the current Saphyr system, but the focus will be on throughput. And consumables, that will really allow us to offer consumable pricing that is approaching $100 per sample. So, as you can imagine, for high volume labs, high volume studies, this is a really incredible capability.
Michael Okunewitch: I'd like to touch on the product mix a bit and the improved gross margins. How much of that is due to the reagent rental model and the Lineagen revenues as compared to higher utilization from existing Saphyr systems and the improvements throughout the years that you just mentioned to the throughput of the system?
Christopher Stewart: It really has a lot to do with the product mix. As you know, with a business like ours, the consumable business will continue to grow and outpace revenue from the systems. In Q1 of last year and throughout much of last year, we were selling systems and the consumable portion of our revenue was growing steadily. And that change in mix and the growth we had year-over-year in the consumables, along with the higher margins from the Lineagen business, is really what drove it.
Michael Okunewitch: Just one more, if you don't mind. I'd like to ask, as you guys get more customers coming onboard who have lab developed tests and they're actually using Saphyr for diagnostics, how does the utilization break down between the customers who have validated LDT and those who don't yet, are using it just on the on the research side?
Erik Holmlin: Sorry, can you repeat that last part?
Michael Okunewitch: I wanted to know how the utilization of Saphyr kind of breaks down between customers who have a validated LDT and are using it in diagnostics versus those who are using it more so just for research?
Erik Holmlin: Listen, so a couple of ways to think about that. First and foremost, I want to emphasize that the Saphyr system is research-use only and customers adopt it and use it for a variety of applications. And when they're developing an LDT, we would consider that to be within the clinical research portfolio, translational research, the LDT that they may have could be for a variety of applications. And the research use spans a pretty wide range. So going all the way from basic research, even non-human research up into this translational research that includes the LDTs. And what we see in current adoption is that it is almost entirely – probably like a conservative figure would be maybe 75% to 80% translational research, human focused, and a smaller fraction, 20 to 25% basic. And those translational applications are much higher volume of utilization. Also, when a site commits to a reagent rental program, the minimum annual commitment is 240 genomes. And so, that's a pretty substantial utilization rate right there.
Operator: We have a follow-up question from Kevin DeGeeter of Oppenheimer.
Kevin DeGeeter: Two more quick ones for me. In terms of new placements, can you just talk a little bit about the typical competitive dynamic as typical site trying to decide between optical mapping and long-read sequencing in terms of their functionality, you really do have some degree competing against yourself in terms of whether the functionality offered by Saphyr will capture value for a given site, are you competing with kind of legacy technologies, just kind of what are you thinking? I'm thinking more for translational and clinical oriented sites, more than perhaps the traditional basic research oriented customer base.
Erik Holmlin: When you're talking about those clinical translational oriented sites, that is a site which is really looking at the Saphyr system or optical genome mapping as an alternative to traditional methods inside of genomic cytogenetic analysis, karyotyping, FISH and microarrays. So, that's where the discussion usually lies. And that's why these comparative analyses that we have ongoing or that sites are conducting and publishing make a difference. And there is certainly an overlapping segment that is looking at a comparison against the traditional methods, but also looking at a comparison against sequencing methods, whether that be long-read sequencing or short-read sequencing or both. As you start to get more and more towards true basic research or discovery research, there, the idea of including optical genome mapping is really an incremental approach. And so, that is a different conversation, that's a different value proposition. It's a different comparative landscape. And so, the types of publications that are so important there are ones that are highlighted, like our slides that show the use of optical genome mapping in all of these different indications relative to sequencing for its ability to find information that otherwise would not be detected. So, really two different paths of generating a dossier of support for the value proposition. And we are pursuing both of those as are customers in the install base, and they're starting to publish on a much more regular basis.
Kevin DeGeeter: Lastly for me. I appreciate that the primary guidance metric the company provides today is placements, matured or iterated, at more than 150 by the end of the year. We do get questions from investors interested in revenue guidance and sort of what you would need to sort of see or what kind of scale in your business you'd need to be able to obtain and feel comfortable providing at least a broad range on revenue guidance. So kind of any thoughts you have on opportunities to further expand the types of guidance metrics to provide for the Street would be helpful.
Erik Holmlin: We're sort of appreciative of that dynamic. And I want to make a couple of comments. First of all, we're conservative about providing guidance because it's on a relative scale basis. The revenues are certainly impressive and we're very happy with where we came out this quarter, last quarter, and what we're seeing on a go-forward basis, and we think it's really reflective of the progress that we're making. Having said that, they're at a scale where even a deal that gets moved from one quarter to the next could change the achievement of a particular threshold, for example. And so, we don't think that that's the right measure of the success of our strategy, which is why we emphasize the growth in the installed base and other things like the number of flow cells that are going out and so forth. So, that's one reason which I understand that you're aware of. But let's not forget about the other reason, which is probably the bigger driver. And that is that, while we're together here in a conference room for an earnings call for the very first time since quarantine began and we're seeing lessening of restrictions around the world allowing us to install systems and so forth, there remains a tremendous amount of uncertainty of what the future holds there. And so, that's another reason why we're conservative about providing guidance. And so, as that continues to clear up and the business progresses, I think we will be in more of a position to do that. And I would look for that probably next year sometime. In the interim, what we, like your investors do, is we pay attention to the analyst reports that are out there. And while some of them are higher and some of them are lower than what we expect, we see the general consensus is kind of representative of our trajectory, which we have said on the last call would be meaningful double-digit growth in 2021 over 2020. But with substantial growth in the installed base of this 150 or more systems and other areas of progress.
Operator: At this time, I'd like to turn the call over to Erik for closing remarks.
Erik Holmlin: Well, I just want to say that – I thank the whole team and everybody at Bionano for everything that they've done to put together this quarter. I want to thank everybody who has joined the call today and followed along with us and we will be back together with you in one quarter's time. So, thank you very much for joining.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
