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spk02: Good day, and thank you for standing by, and welcome to the MaxSight Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to introduce your host for today's call, Sean Menarges, Senior Director of Innovation and Business Development. Please go ahead.
spk04: Well, thank you, Justin, and good afternoon, everyone. My name is Sean Menarges. I'm the Director of Innovation and Business Development here at MacSite. Thank you all for participating in today's conference call. On the call from MacSite, we have Doug Zorkler, President and Chief Executive Officer, and Douglas J. Swirsky, Chief Financial Officer. Earlier today, MacSite released financial results for the third quarter ended September 30th 2023. A copy of the press release is available on the company's website. Before we begin, I need to read the following statement. Statements or comments made during this call may be forward-looking statements within the meaning of federal securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Actual results may differ materially from those expressed or implied, and any forward-looking statements due to a variety of factors, which are discussed in detail in our SEC filings. The company has no obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll turn the call over to Doug.
spk01: Thank you, Sean. Good afternoon, everyone, and thank you for joining MaxSight's third quarter 2023 earnings call. I will begin with a discussion of our business and operational highlights during the quarter, followed by a detailed financial review from Doug Swirsky, DJ, our chief financial officer. We will then open the call for questions. MaxSight reported $8 million in total revenue in the third quarter at the high end of our preannounced revenue range. Core revenue was $6.6 million, also at the high end of our preannounced range. Over the last month, the business has performed in line with the expectations we laid out on our call on October 4th, and today we are reiterating our revenue guidance for the full year of 2023. The operating environment for our customers has largely remained unchanged from when we spoke in October. Our primary focus remains on driving commercial execution to improve performance across our business, and the commercial organization at MaxSight is actively working to increase and expand sales opportunities for the balance of 2023 and into 2024. I will briefly revisit some of the challenges we are facing that drove the pre-announced reduction and our revenue guidance, which we pointed to in our call on October 4th. The primary driver of core business performance was softness and processing assemblies, or PA sales. We continue to believe can be attributed to these three factors. Early stage customers in cell therapy and drug discovery conserving spend and reevaluating their pipeline portfolio and R&D initiatives. Customers built up inventory in 2022, and due to the prioritization of programs and reduction in spend, the existing inventory has covered more of their PA needs. And third, clinical SPL partners delaying clinical timelines due to challenges in obtaining additional financing for their clinical operations. Another factor in the weakness of our core business performance was early stage customers becoming incrementally more conservative on capital expenditures as the year has progressed, which has impacted our instrument placements. Though we have seen the macroeconomic operating environment play out unfavorably this year, we continue to see cell therapy industry trends that favor MagSight's platform. The industry continues to move toward non-viral cell engineering, approaches that include multiple pathway engineering steps across many diseases. Specifically, our partners continue to expand their cell therapy indications into new unmet needs, including autoimmune disease, providing us with the opportunity to support our partners as they scale up and scale out their manufacturing process. Furthermore, developers are increasing the complexity of their cell therapy product with multiple edits on the cell, which positions MaxCyte well given the platform's high cell engineering performance across a wide variety of gene edits and gene-edited modalities. Developers are also looking into multiple doses and or increased dosing regiments for complex indications which further supports the market need for engineered large cell volumes. Our customers and partners can leverage our scientific, technical, and regulatory support and capabilities to optimize the clinical manufacturing process for the growing set of cell therapy applications. Just this year, we signed five SBL partnerships, which highlights the value that our platform brings to our customers. We continue to see a healthy pipeline of potential partners, All in all, we are encouraged by the non-viral engineered cell therapy trends in addition to the potential for our partners to make an impact as they progress their programs through the clinic and reach commercialization. We remain highly engaged with our customers, both current and prospective, and are excited by the opportunity to expand our SPL partnership portfolio and grow our revenue. In the third quarter, we reported SPL program-related revenues of $1.4 million and remain confident that we will at least meet our guidance of approximately $6 million this year. We believe this high-value revenue line will continue to be meaningful in the coming years as several waves of different therapies we support potentially come to market. We are excited by partners' progress and look forward to the potential impact of therapies that utilize MaxSight's platform. Looking ahead, there is substantial clinical milestone and commercial revenue opportunity for MaxSight as our partners move toward late-stage clinical development and commercialization. In what would be the first commercially approved product enabled by our platform, CRISPR Vertex Exacell is nearing the PDUFA date of December 8th, 2023 and March 30th, 2024 for sickle cell and beta thalassemia, respectively. Just last week, on October 31st, the FDA held an ADCOM meeting to discuss the treatment, which highlights the therapeutic benefit of Exacell and the important medical advance for the field and for patients. As a reminder, we believe that all necessary investments in manufacturing and regulatory quality have been made on our end to support Exacell's commercial launch. We look forward to the potential FDA approval of the first non-viral engineered cell therapy product validating MaxSight's platform. and which would also result in a significant milestone payment to us under our partnership with Vertex. We continue to be excited about the prospects of the VLX platform and our expansion into the bioprocessing market. To provide some context, we are looking to help our customers improve workflow efficiency and accelerate time for the preclinical and early-stage manufacture of monoclonal antibodies, recombinant proteins, and vaccines. The VLX has a unique capability to enable rapid production of transiently expressed proteins at larger scale for preclinical and early clinical use in a much more efficient time horizon than the standard practice. As a result, customers will be able to evaluate more preclinical leads at an appropriate scale and derive conclusions from late-stage preclinical research activities sooner than they normally would, enabling them to proceed with development in a much faster time frame. The efficiency that VLX brings to the process can potentially accelerate important decisions on late-stage preclinical development to enable developers to prioritize their clinical investments to the most promising assets. We believe that the current market opportunity for the VLX is across approximately 3,000 preclinical assets in monoclonal antibody, recombinant protein, and vaccine development, and we are optimistic about our opportunity in the coming years. To lead this effort, we recently appointed Ali Soleimanizad as Executive Vice President of Bioprocessing. Ali has been an important addition to the leadership team at MaxSight with almost 20 years of experience in biomanufacturing, bioprocessing, and bioanalysis, including serving as Executive Vice President for Separations and Purification at Toso Biosciences prior to joining MaxSight. We firmly believe that he will guide the future of MagSight's bioprocessing business, beginning with the growth of the VLX platform. For the remainder of 2023 and into 2024, we are focused on supporting our customers and partners through targeted investments. We have already made substantial progress in enhancing our infrastructure and scientific and manufacturing capabilities to support customers pursuing complex cell therapies in the clinic, as well as when they reach commercialization. Over time, we believe the investments we are making today will drive substantial incremental value as we support multiple partners at various stages of development and commercial activity. In closing, we continue to navigate the current operating environment with tact and flexibility. MaxSight remains committed to supporting our current SPL partners in their program development and further expanding our portfolio partnerships. With that, I will now turn the call over to DJ to discuss our financial results. DJ?
spk07: Thanks, Doug. Hello, everyone. Total revenue in the third quarter of 2023 was $8 million, compared to $10.6 million in the third quarter of 2022, representing a 25% decline. In the third quarter, we reported core revenue of $6.6 million, compared to $9.9 million in the comparable prior year quarter, representing a 33% decline. This includes revenue from cell therapy customers of $4.7 million and revenue from drug discovery customers of $1.9 million, which declined 40% and 5% year-over-year, respectively. The decline in revenues was primarily the result of softer PA cells as well as weaker instrument sales, primarily in cell therapy due to the challenging funding environment. Revenue from instrument and PA sales were down 44% in the third quarter, quarter compared to the previous year, and revenue from leased instruments declined 11 percent, driven by the challenging operating environment that our customers continue to face. We recognized $1.4 million of SPL program-related revenue in the third quarter of 2023, as expected, due to our partners' continued progress through the clinic compared to $0.8 million of SPL program-related revenue in the third quarter of 2022. Moving down the P&L, gross margin was 90% in the third quarter of 2023 compared to 87% in the third quarter of the prior year, driven by our mix between core and SPL program-related revenue. Total operating expenses for the third quarter of 2023 were $21.2 million compared to $17 million in the third quarter of 2022. The overall increase in operating expenses was primarily driven by R&D, sales and marketing, and manufacturing expenses. The company continues to strategically invest in commercial sales and marketing operations, innovative product development and field application scientists, automated manufacturing capabilities, as well as business and corporate development to drive long-term growth. We finished the third quarter with combined total cash equivalents and investments of $208.7 million, and of course, no debt. Moving to our full year 2023 guidance, We updated our outlook on our third quarter preliminary results conference call on October 4th, and we are reiterating that outlook today as we expect total revenue for 2023 to be approximately $34 to $36 million. Core revenue is expected to be approximately $28 to $30 million for the year, and SPL program-related revenue expectations remain unchanged from our previous guidance at approximately $6 million for the year. Our updated guidance incorporates cautiousness around the challenging funding environment and customer purchasing patterns for the remainder of 2023. As we have discussed previously, the timing of partnership revenue is dependent upon our customers' clinical and regulatory progress and is fundamentally more difficult to predict than our core revenues, which clearly has also been difficult to forecast this year due to the challenging operating environment discussed earlier. Finally, MaxSight remains in a strong financial position and continues to expect to end 2023 with approximately $200 million in cash, cash equivalents, and investments, and no debt on our balance sheet. Our expected cash burn for 2023 is approximately $27 million, in line with our 2022 cash burn of approximately $28 million. We have prudently managed our expenses and burn in 2023 and executed disciplined cost management in order to position the company to achieve our long-term goals. I would like to close by reiterating that we remain confident in our 2023 revenue outlook, and we believe that our modest cash burn and balance sheet will support our future plans for long-term growth. Now I'll turn the call back over to Doug.
spk01: Well, thank you, DJ. Overall, despite the challenging operating environment this year, we firmly believe in the long-term outlook for MaxSight. We're excited about the potential of our partnerships as they progress their assets through the clinic, and we remain committed to expanding our partnership portfolio to support the development of advanced cell-based therapeutics in the growing cell and gene therapy industry. As always, we thank our MaxSight team, as well as our board, suppliers, investors, partners, patients, and the great industry that we have the honor of serving. With that, I will turn the call back over to Justin for the Q&A. Justin?
spk02: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
spk10: Please stand by while we compile the Q&A roster. One moment, please.
spk08: And one moment, please. And our first question comes from Dan Arias.
spk10: Your line is now open.
spk03: Hi, everyone, guys. Thanks for the questions here. Doug, maybe just a couple on the instrumentation side. Specifically on cell therapy, do you expect the lease versus sold dynamic to change at all in light of the things that are going on in the industry? The lease has become a bigger part of that mix. And then on the VLX system, appreciate your comments there. Anything quantitative that you might be able to add on the launch? And then along those lines, I mean, when we think about usage there, I'm curious whether you think some of this program prioritization that's taking place across the industry could impact the adoption curve, just in the sense that, you know, to your point, it's a good tool for evaluating preclinical assets. Some of those are being backburnered right now, so maybe less of a need for that kind of horsepower. Do you see that as a likely outcome or not really? Thanks.
spk01: There's a lot of questions there, Dan. Yeah, there are. Sorry about that. That's okay. Let me take two cuts at this and see if I answer all your questions. On the business model instrument side, I made a comment about being tactful with our partners, and I think it's truly important that we understand the situation they're in. We look at our business model, and we're going to make changes as we feel are appropriate for helping our partners. And we're seeing the rationalization of these pipelines, and I do foresee us, we may very well make some changes to our business to our approach for the business model. Although I don't think they're going to be major approaches, they'll be around the edges. And again, you know, thinking through kind of the new use cases for our technology, you know, moving into autoimmune disease where you have, you know, large patient populations. So I think you're seeing the cell therapy industry, you know, moving from autologous blood, you know, blood center therapies to moving into solid tumors and now autoimmune where it's going to open up to serve populations. So we're excited about that. And that, of course, is going to have an impact on our business model. On the VLX, quantitatively, we put a slide in the deck that laid out the difference between what we believe our system and being able to produce a protein in a couple months versus the traditional way, which could be six months plus. I think that when there's more rationalization, I think there's going to be a lot more attention placed on speed to market, speed to decisions, and I think that's exactly what we're focusing our attention on. It's whatever we can do to reduce the early stage preclinical development timeline for these partners, and they could be big pharma, they could be a relatively early stage ADC company. They're all looking to do the same thing, and that's to get better products into the market faster, and if we can you know, cut six, four, six months, a year off of that timeframe, we think that's, that's pretty valuable. So we're excited. We think the VLX is coming in at the right time, um, to, you know, to address some of the problems I think that are, um, we're seeing in the industry at large.
spk03: Okay. Appreciate you sticking through those there. Uh, maybe just one quick followup to your point. We are closing in on this XSL decision here. Obviously we'll see how that ends up, but if we were to assume approval, I'm just curious about your expectation for a ramp in instrument utilization and consumables consumption as scale presumably takes place there, scale up presumably takes place there.
spk01: Well, we obviously can't give you any guidance in terms of what 24 looks like, and this would be a 24 event. That said, we have been investing in ensuring that we've got instrumentation support from Vertex's side and CRISPR's side in terms of manufacturing. and we're ready to scale up. I think we just saw an announcement they made, I guess, yesterday in a press release about getting a breakthrough therapeutic designation in Saudi Arabia. So it'll be interesting to see how this business develops and expands, but be assured that we're prepared fully to support them and execute against whatever plan they believe makes the most sense from them commercially.
spk09: Okay. Thank you, Doug.
spk01: Thank you.
spk09: Thank you. One moment, please. Our next question comes from Jacob Johnson with Stevens, Inc.
spk00: Hey, good afternoon. This is actually Hannah on for Jacob. You've talked about expanding your geographic reach. Is this still a priority in this environment?
spk01: That's a good question. I think the world's changing, of course. I think we're all focused on how we can navigate the China situation. Frankly, I think this is more of an organic expansion. The science around cell therapy is expanding well beyond the U.S. and Europe. and moving into Eastern Europe, it's moving into South America, moving certainly to APAC. And so we're following where those hubs of activity are. For us to enter into that, a new geography, it could be as simple as us bringing a field application scientist and a salesperson into that account. It could be as extensive as bringing in a new distributor or building out more on land field applications people. So I think our interest is always to follow the science, always follow where the commercial cell therapy field is heading. And then we'll make the decision what makes the most sense from an investment perspective for us.
spk00: Thanks. And then you're tracking ahead of your usual three to four SPL additions per year with five this year. How many are you expecting to add total in 2023? And do you expect the annual rate of additions to continue to outpace three to four in the future?
spk01: We'll talk about 24 when we give guidance or when I resist talking about that. You know, I think we're pretty comfortable with the five we did this year. We really, I don't think we are in a position to talk about anything additional in 2023.
spk00: Great, thanks. I'll leave it there.
spk01: Thank you.
spk09: Thank you. One moment, please. Our next question comes from the line of Matt LaRue with William Blair.
spk06: Good afternoon. You know, there was earlier this year sort of a, it seemed like a round one of RIFs, restructurings, pipeline per stations, and then it seems that over the last couple of months we've maybe had a round two, and a number of your SPL partners have, you know, been impacted by that in terms of RIFs, restructurings. Just would be curious for your perspective on you know, how much potentially more there is to go just in your interactions with SBL partners or core revenue, core customers, you know, how much they've really cut down programs to true high priority assets, how much they've brought down their teams from a size perspective, just as maybe as a different way to gauge what inning of sort of the drawdown in the industry we're at.
spk01: What is the question that I'm trying to understand? I agree with you that we're in a situation right now where we've got companies and partners who are scaling back. We've seen a couple of them just most recently. Lyle, for instance, and Sana did another one. So we're keeping pace with those customers. We're staying close to those. What we're seeing is that when the focus in the rationalization is being drawn toward our products that we're currently involved with them. So that's a good sign. I think overall, it's a strong point for MaxSight that we're working on those lead assets. I think it's very difficult for us to try to predict where the next situation is. I mean, companies won't share that with us, obviously. They're going to announce it when they announce it, and we're going to react and hopefully manage well with them as they make those decisions. I'm not sure I answered your question, though. Is there something more specific that you were looking for? I just want to be responsive to you, Matt.
spk06: No, I guess it was maybe unintentionally vague, but I think you addressed what I was kind of hoping to get at. So, you know, the second one would be you referenced, you know, I think Dan's question around sales versus lease of instruments that you're willing to make changes as appropriate to help partners. So that may be an internal change in response to the macro environment. Have you noticed or aware of any sort of external changes, be it, you know, competitive behavior around, you know, giving away instruments or cutting prices? Have you noticed any price pressure or additional competition in the changing macro environment?
spk01: I think our value proposition still holds true. I mean, it's all about reducing risk and accelerating development, and those are two things that all these companies obviously want to do. One indication is our gross margins, 90% gross margins in the quarter, and I think that's a tribute to our ability to maintain pricing in the marketplace. So just to give you those kind of data points right now, we're feeling pretty comfortable with where we are in terms of competition. We're not really seeing anything kind of in our area. We have mentioned ZN on in the past. We've seen lines that come in and out. a lot of companies that are trying to get into the space, kind of newer companies that are trying to figure out how they can take us on. I think that's just a healthy environment. It points to the importance of non-viral cell engineering in the future. And I would predict that after XSL gets approved, there will even be more people interested in trying to figure out how big that market is and how they can participate. That said, we're in a great position. with our partners and our technology, and we're continuing to be the go-to, you know, premier company in this space.
spk06: Okay. The last one is to follow up on VLX. You know, earlier this year on the fourth quarter call, you, you know, mentioned that there was, it was revenue generated in 22, that that would grow in 2023. We're now a little over a year into the launch, so I, you know, I think it's just sort of an early access focused launch, but Is there anything you can share with us about how much VLX is contributing to the financial model at this point, or is that something that you may be able to start sharing next year?
spk01: I think we'll be much more comfortable sharing it next year. You know, Ali's on board. He's doing a great job really increasing the visibility of the offering to, you know, high-profile clients and, you know, really just talking – about how disruptive this technology is and how important it's going to be for early stage development of these programs. So I think we'll be able to provide a much more fulsome view of the strategy and provide some expectations when we do 724. Thank you.
spk08: Thank you.
spk09: One moment, please.
spk08: Our next question comes from Steven Ma with TD Cowen.
spk05: Great. Thanks for the questions. Maybe a follow-up to Hannah's questions on SPL ads. Maybe I'll ask it a different way. This is more with regards to the funnel of your SPL leads. Has the potential success of XSL, has it led to more business development inbounds or tractions with potential partners?
spk01: I think the pipeline itself continues to be really, really strong and great. We're having excellent discussions with folks. Some of them fall into the same camp that we've been talking about where they have their early stage development companies and they really don't have the financial support to move into the clinic. And so that can pause our SBLs, although I think it's fair to say that we've got other companies that we're working with that may not have that same situation and they're moving forward. I think, well, my sense is that when XSL gets approved, I mean, I think you heard it in the, you heard it in the, if you, we heard it, we did. We heard it in the ad count meeting that there was very little concern about the manufacturing of that product. The safety profile looked great, and the clinical evidence was extraordinarily strong. So our sense is that once that product gets approved, I think that's going to check a big box in the industry. and they're going to be looking upon us as the company that's going to be able to help accelerate and move those non-viral cell therapy assets into the clinic and through the clinic. And again, as we've mentioned, we continue to see an expansion of cell therapies into new indication areas like autoimmune, for instance. We're seeing a lot of that in the last few months, and that will require, no doubt, more volume of cells to be delivered to the patients on a longer period, more of a chronic therapy. And I think that fits well with the scale and the efficiency of our system.
spk05: Great. Thanks for that, Keller. And, you know, one more question. You know, when you brought the guide down in October, you mentioned, you know, inventory, destocking of process assemblies. Some of the bioproduction companies recently said on earnings that they're seeing a bottom with regards to destocking headwinds. Could you comment on what you're seeing out there? And if you have any customer visibility that suggests maybe there could be an uptick as activity picks up, as this excess inventory gets used? Thank you.
spk07: Thanks for the question. This is DJ. So, you know, part of the challenge in answering that is, you know, we've got seven weeks left in the year. We don't want to start providing guidance for 2024 talking about, you know, how we see that year starting off. But what we can say is that, you know, we've taken a very conservative view on PA sales just because, you know, we wanted to make sure that we would be, you know, comfortably providing this revised guidance and meet it and possibly exceed it. So we're very close to our customers. We've got a good sense that we've got a good number here for you. And a big part of that is PA. So if you look at the breakdown of why we're confident with the revised guidance, you know, we have very good visibility into the lease revenue. We've got seven weeks left in the year to execute against, you know, a good number of opportunities of which only a fraction would need to close in order for us to be comfortable with our number. And, of course, on the PA side, as we mentioned on the October call, We've really brought that down. We haven't factored into any recovery. We haven't factored in any of the seasonality that we've seen where, you know, you do get some larger pre-A purchases later in the year. We're just basically going off the daily run rate that we saw in Q3, which was depressed, and that gives us some comfort. But, you know, to fully answer your question, I think we certainly need to delve into what happens seven weeks from now in entering 2024, and we're just not in a position to provide really too much information there.
spk05: Okay, fair enough. Thanks for the questions.
spk09: thank you i'm showing no further questions i'll now hand the call back over to doug dorfler for any closing remarks thank you justin and thanks everyone for joining us today and your in your uh questions uh we look forward to providing an update on the fourth quarter call so thank you all very much have a great thanksgiving thank you ladies and gentlemen thank you for participating this concludes today's program you may now disconnect
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