MaxCyte, Inc.

Q4 2023 Earnings Conference Call

3/12/2024

spk01: Good day, and thank you for standing by. Welcome to the MaxSight fourth quarter earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during a 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 hand the conference over to your first speaker today, Sean Menarges, Senior Director of Innovation and Business Development. Please go ahead.
spk09: Well, thank you, and good afternoon, everyone. My name is Sean Menarges, and I'm the Senior 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 Meher Masood, President and Chief Executive Officer, and Douglas J. Sworsky, Chief Financial Officer. Earlier today, MaxSight released financial results for the fourth quarter and full year ended December 31, 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 other than statements of historical facts provided on this call, including statements regarding our future results of operations or financial condition, Business strategy and plans and objectives of management for future operations are forward-looking statements. These statements about us or our industry involve substantial known and unknown risks, uncertainties, and assumptions, including those that are discussed in detail in our annual report on Form 10-K and elsewhere in our SEC filings. That may cause our actual results, performance, or achievements to be materially different than any other futures results, performance, or achievements expressed or implied by such statements. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements. The company undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. And with that, I'll turn the call over to Maher.
spk06: Thank you, Sean. Good afternoon, everyone, and thank you for joining MaxSight's fourth quarter and full year 2023 earnings call. As you know, I was appointed to the role of president and CEO of MaxSight effective as of January 1st of this year. It is an honor to lead MaxSight through its next phase of growth after working closely with the executive team and board over the last seven years. I would like to thank our founder, Doug Dorfler, for his contributions to MaxSight over the past 25 years. In my first couple of months as MaxSight CEO, we have continued to execute our core mission and strategy, to expand our strategic platform licenses, or SPL, portfolio, and support the next generation of cell-based therapies with our expert exploration platform. Our top priority remains supporting our customer success throughout the lifecycle of research, clinical development, and commercial launch. I believe we have substantial opportunities ahead of us in the cell therapy industry, and I am committed to leading our organization with a high level of focus, along with disciplined expense management and capital deployments. 2022 is a challenging but exciting year for MaxSight. We faced a difficult operating environment, along with many others in the industry, as our customer base saw conservatism in capital spending, lower than expected activity levels, and prioritization of programs. Despite these challenges, 2023 was a transformative year for MaxSight. Our technology supported the approval of Cash Chevy, the first non-viral cell therapy product approved by the FDA, developed by SPL clients CRISPR Therapeutics and Vertex Pharmaceuticals. MaxSight's expert platform is now the only electroporation platform to have supported a non-viral therapy through FDA approval and is now the only electroporation platform supporting a commercial therapy. We believe this is just the first of many potential approvals by MaxSight SDL clients over the coming years, and we are working hard to remain the platform of choice when it comes to electroporation. MaxSight reported $41.3 million of total revenue for the full year of 2023 at the high end of the revenue range we preannounced in January 2024. Our core business revenue was $29.8 million, also at the high end of our pre-announced range. We were pleased to see our business begin to stabilize in the fourth quarter and with a strong execution of our team in a challenging environment. In 2023, we grew our instrument install base to 683, as compared to an install base of 616 at the end of 2022. While our instrument install base expanded this year, both instrument sales and PA sales declined in 2023 compared to 2022 across cell therapy and drug discovery customers. As I mentioned, we are operating in a challenging environment where early-stage customers in cell therapy and drug discovery have limited access to capital, and some clinical customers have adjusted their spending and extended project timelines. This environment remained largely unchanged in the fourth quarter, though we are optimistic that the financing market for the cell therapy industry will improve over time. Non-viral cell therapy market trends continue to bode well for MaxSight's platform. Customers at various stages of development are pursuing different approaches and indications. Developers continue to move towards non-viral cell engineering approaches that encompass multiple steps and complexity of edits. Innovation and complexity in cell therapy development drives demand for MaxSight's electroporation technology. While we are cautiously optimistic about near-term market factors impacting our customers, the non-viral cell therapy opportunity and regulatory backdrop for cell therapies continues to improve. Outside core business, we generated $11.5 million of SPL program-related revenue for the full year of 2023 and $8.5 million during the fourth quarter. Both our full year 2023 and fourth quarter 2023 SPL program-related revenue came in at the high end of our pre-announced range, driven primarily by BLA approval milestones from our client in the fourth quarter of 2023. As a reminder, SPL program-related revenue includes development and approval milestone payments. as well as sales-based payments and or royalties from commercial clients. Across our 26 SPLs to date, there are many nuances to the SPL contracts, and the revenues associated with commercial products can vary. Generally, we receive 1% of product sales through either a royalty or sales-based payments, in addition to receiving revenue from lease instruments and PA sales to SPL customers, which is included in core revenue. As stated by Vertex in their fourth quarter 2023 earnings call, the commercial launch of Cash Chevy has commenced. As patients are screened and identified for treatment, they will enter the program at authorized treatment centers, in which they will undergo pretreatment, cell collection and manufacturing, and finally, treatment infusion. MagSci will only recognize revenue once the patient has been infused, which can take a number of months from the time the patient enrolls in therapy. Our visibility into the timing of patient dosing is quite limited, and we will rely on Vertex to provide us and the markets with updates on patient enrollment status as they come. At this time, we do not have enough information on timing of patient dosing, to forecast expected commercial royalty revenue from the sale of Cashevi for 2024. As we move throughout the course of the year, we hope to have better insight into the patient journey and dosing timelines. We remain very optimistic about the long-term prospect for Cashevi and look forward to many patients receiving the treatment in the years to come. As I mentioned earlier, we continue to lay the groundwork for long-term growth at MaxSight, just as we did several years ago with CRISPR to support what is now Cashevi. In 2023, we signed five new SPL clients, bringing the total number of SPLs to 23 as of December 31st, 2023. These 23 SPLs represent over 160 programs, of which 16 are programs in clinical development along with one commercial program. The total pre-commercial revenue potential for SPL programs is now greater than $1.95 billion, up from $1.55 billion at the end of 2022, an increase of over $400 million in potential milestone payments. As you've probably already seen thus far in 2024, we have signed three additional SPLs, bringing our total assigned SPLs to 26 as of today. We believe the breadth of our expanding SPL portfolio continues to demonstrate the unique and valuable technology at MaxSight used across cell types and editing tools. By way of example, Lion TCR, one of our SPL customers, which we announced this year, is a Singapore-based clinical stage biotechnology company focused on the development of T-cell receptor therapies for solid tumors and life-threatening viral infections. Our SPL-aligned TCR has allowed us to expand our global presence into Asia to support the development of new therapies for patients with solid tumors. We also signed an SPL with Imogene, a clinical stage immuno-oncology company that is developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors. Our platform technology was officially transferred from Precision Biosciences when global rights for Azacel were obtained by Imogene in August of last year. And we look forward to supporting Imogene as they move towards a potential Phase II Registrational Trial for AIDS of Cell and Cancer, an allogeneic CAR-T candidate. Our most recent signed SBL client is with WooGen, a clinical stage biotechnology company developing allogeneic off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies. Importantly, their WooCAR-T007 lead asset is currently in a global Phase I-II clinical trial for the treatment of relapse or refractory T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma in adolescent and adult patients, and has received orphan drug, fast track, and rare pediatric disease designations from the FDA for the treatment of such conditions. We are encouraged by these recent SPLs and are excited to witness the clinical progress that we believe our clients may make in the upcoming months and years with the support of our platform. The SPL agreements that were signed earlier this year have been many months or even years in the making. our team works very hard with customers to understand and optimize their research and development processes and objectives. This relationship often starts in research where customers utilize our expert ATX and then seamlessly scale to the GTX prior to entering the clinic. As companies make progress towards entering clinical development, there's dynamic discussion around the SPL relationship that takes quarters to negotiate and arrive at the final agreement. Following the success of our ability to enter into new SPLs over the past couple of years, we are continuing to build and expand the SPL pipeline. As time progresses, we believe that having the only commercial non-viral therapy which utilizes our platform to engineer the cells will generate additional interest in finalizing a number of new SPL agreements, which have been in discussion for some time, and that new discussions can begin to support continued SPL signings in the years to come. We believe that there is opportunity for substantial clinical milestone and commercial revenue as our SPL clients programs move towards late-stage clinical development and commercialization. As we look ahead in 2024, we have a robust SPL pipeline, which we will continue to execute on. Over the past two years, MaxSight has strategically invested to support the growth opportunity ahead of us. Notably, we have made investments to ensure that we have the strongest manufacturing, regulatory, and quality capabilities to support our customers throughout development and commercialization. We have added to our teams across the organization in order to scale the business. and we have made targeted product development enhancements, including development of the BLX. We have developed disruptive technology in the BLX that will enable rapid production of transiently expressed proteins at large scale for preclinical and early clinical use that we believe will offer a much more efficient manner for research. We believe the commercial opportunity in the bioprocessing market is large, but will take some time to develop. Following feedback from industry and a more detailed evaluation of the opportunity for the BLX, We are taking a more measured approach to developing applications and understanding customer needs before launching a robust commercial offering for the VLX. We remain committed to taking the time necessary to deliver the most efficient platform for our customers, starting with the evaluation of our beta customer feedback throughout 2024. In 2024, we will be measured in our investments and focus on areas that we believe will deliver significant returns to our customers and MaxSight in the long term. The key areas of moderate investment may include improvements to our best-in-class electroporation systems, building additional application know-how, building capabilities to work with customers earlier in the continuum of development, and selling into new applications for electroporation. In summary, we have entered 2024 well-positioned to deliver on our financial and strategic goals. This year, Maxell will continue to navigate the operating environment methodically, recognizing that the challenges we experienced in 2023 were felt industry-wide, and staying vigilant of changing dynamics in our industry. I firmly believe in the long-term opportunity for MaxSight as the premier enabler of non-viral cell therapies. With that, I will now turn the call over to Doug to discuss the financial results. Doug?
spk08: Thank you, Mayor. Total revenue for the full year was $41.3 million compared to $44.3 million in 2022, representing a 7% decline. Total revenue in the fourth quarter of 2023 was $15.7 million, compared to $12.4 million in the fourth quarter of 2022, representing an increase of 26%. In the fourth quarter, we reported core revenue of $7.2 million compared to $10.6 million in the comparable prior year quarter, representing a 32% decline. This includes revenue from cell therapy customers of $5.5 million and revenue from drug discovery customers of $1.6 million, which declined 27% and 46% year over year, respectively. Within core revenue, instrument revenue was $2.3 million compared to $3.7 million in the fourth quarter of 2022. Lease revenue was $2.4 million compared to $2.8 million in the fourth quarter of 2022, and processing assembly, or PA revenue, was $2.2 million compared to $3.7 million in the fourth quarter of 2022. We saw sequential improvement in instrument revenue and stabilization in PA revenue compared to the third quarter of 2023. The year-over-year declines in revenue were due to the challenging market for our customers, which resulted in conservatism of spend and pipeline prioritization. For the full year of 2023, we reported core revenue of $29.8 million compared to $39.6 million in 2022, representing a 25% decline. This includes revenue from cell therapy customers declining 25% year-over-year and drug discovery revenue declining 23% year-over-year. Within our core revenue, instrument revenue was $8.3 million compared to $11.7 million in 2022. Lease revenue totaled $10.3 million compared to $10.9 million in 2022, and PA revenue totaled $10.3 million compared to $16 million in 2022. Of note, 48% of our core business revenue was derived from SPL clients in 2023, which compares to 42% and 40% in 2022 and 2021, respectively. The increase in revenue from SPLs as a percentage of total core revenue highlights the challenges that early stage preclinical customers face during the course of 2023, which we have spoken to throughout the year. While our SPL clients were not immune to funding constraints and pipeline prioritization, the magnitude of the decrease in core revenue from SPL clients was less substantial compared to our earlier stage customers. We recognized 8.5 million of SPL program-related revenue in the fourth quarter of 2023 compared to 1.9 million of SPL program-related revenue in the fourth quarter of 2022. For the full year, we recognized 11.5 million in milestone revenues as compared to 4.6 million in 2022. We exceeded our initial milestone guidance for 2023, which was a risk-adjusted forecast for the year. The approval milestones from our SPL client in multiple geographies drove the upside to our initial guidance. Moving down to P&L, gross margin was 90% in the fourth quarter of 2023 compared to 88% in the fourth quarter of the prior year, driven by our mix between core and SPL program-related revenue. Total operating expenses for the fourth quarter of 2023 were $22.2 million compared to $17.6 million in the fourth quarter of 2022. The overall increase in operating expenses was primarily driven by compensation expenses related to headcount, professional fees, and lab and new product development expenses. Moving forward, the company plans to continue to make strategic targeted investments while moderating a rate of OpEx growth. In 2024, We will be disciplined in our spending, evaluating investments in business and corporate development, commercial sales and marketing operations, and field application scientists to drive long-term growth. We finished the fourth quarter with combined total cash, cash equivalents, and investments of $211 million and no debt. Moving to our full year 2024 guidance, we provided initial guidance last week, and we are reiterating that outlook today. We expect core revenue of flat to 5% growth as compared to 2023. The components of our core business are anchored in least revenue of clinical and commercial instruments, new instrument placements, and the sale of processing assemblies, the consumables used by our customers. We are confident in our ability to grow the core business in 2024. We are not forecasting any substantial positive or negative change in the macroeconomic environment for our customers, though I will note that the capital raising activity by the industry and some of our customers has started off better than we expected. Time will tell whether that capital finds its way to R&D programs that will drive demand for MaxSight products, but we are keeping an open ear to customers and the potential for updated plans as market conditions evolve. We adapted to the difficult environment we saw in 2023 and are confident in our ability to execute through a stabilizing environment in 2024. SPL program-related revenue is expected to be approximately $3 million in 2024. This is a risk-adjusted forecast that is achievable under a variety of potential outcomes across our SPLs and their planned clinical progress. At the end of 2023, we recognized milestone revenue from one of our clients, which we had initially anticipated in 2024. Our expectations for SPL program-related revenue for 2024 reflect the timing of this milestone and the resulting difficult year-over-year comparison. While we do not have visibility on the timing of Caschevi patient infusions, we expect to begin to recognize royalty revenue from Vertex later in the year. However, we have not included royalty revenue from Caschevi in our initial 2024 outlook. Finally, MaxSight remains in a strong financial position and continues to expect to end 2024 with approximately $175 million in cash, cash equivalent, and investments, and no debt on our balance sheet. I would like to close by stating that we are confident in our 2024 revenue outlook and believe that our modest cash burn and strong balance sheet will serve to support MaxSight's long-term growth. Now I'll turn the call back over to Maher.
spk06: Thank you, Doug. Overall, we believe our accomplishments in 2023 have further validated the importance of our expert electric operation platform and the long-term growth potential for MaxSight. We look forward to supporting our customers through their development stages and commercial activities to deliver new cell-based therapies to patients in need. MagSci remains excited about the potential of our clients' assets as they progress through clinical development, and we are committed to expanding our SKL portfolio in 2024 and beyond. I'd like to thank the MagSci team for their dedicated work, which has helped solidify MagSci's position as the premier enabler of non-viral cell therapies. With that, I will turn the call back over to the operator for the Q&A. Operator? Thank you.
spk01: And as a reminder, to ask a question, you need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from Jacob Johnston from Stevens. Your line is open.
spk02: Hey, good afternoon, everybody. Thanks for taking the questions. Maybe, Doug, just first on the guidance, I guess two questions. One, it doesn't sound like you're seeing any improvement in the end market. Can you just talk about if you've seen any signs from kind of the recent funding, maybe more positivity from your customer base? And two, I understand we're not including cash chevy royalty in the program revenues. Is any of that contemplated in the, any PA or any PA sales contemplated in the core revenue guidance? Great. Thank you, Jacob.
spk08: So, I'll take those questions one at a time. First, with respect to the guidance that we're providing and how how we might be feeling about the macro environment. We've tried to be realistic and set conservative, achievable goals for ourselves this year. We do believe that we'll possibly hit the trough in terms of the overall market in cell therapy and our other end markets. So we're cautiously optimistic that things could improve this year, but this guidance does not really reflect an improving environment. So I think that there's certainly some upside there if the market improves. We've seen some early signs and reasons to be encouraging some large financings done, and we'll see how that additional capital that's available that's flowing into the space might benefit us. But again, we're just being conservative. The way we build our revenue has always been based on buildup from specific identified opportunities on the instrument placement side, It's using a PA run rate that's where we were at the end of last year, as opposed to expecting and building into the forecast that things would improve. So, again, I think a conservative and realistic forecast, and if the market improves and we do see some reason to be optimistic, then we could potentially benefit from that, but it's not built into the forecast. With respect to Cass Jaffe, what we've done there is we're not including in our guidance for SPL program-related revenue. We're not including anything there. It's just, you know, challenging to really look at that. And also, we don't want to get ahead of our partner in terms of, you know, predicting what sales would be. Some of the growth in for revenue, again, we're projecting or we're guiding to zero to flat. And so, we assume there'll be some growth and that that growth is going to be sort of with and without additional PA uptake from cash chevy.
spk02: Got it. Thanks for that. And then maybe, Mahir, you mentioned, you know, how important the support of a commercial therapy is and that maybe it'll help you close some additional SPLs. I'm just curious, you know, it's been a couple months since the approval of cash. I'd be just curious kind of what your business development team's heard in those last couple months and if you're getting more inbounds now that you support a commercial therapy.
spk06: Yeah, thank you, Jacob. Nice getting a question from you as always. I guess, you know, I just want to take a step back. Obviously, Cash Chevy has been validating, as I've said before, in terms of what it means for the company and also what it means for the non-viral ex-feeble space. But in terms of, you know, obviously we signed three SPLs this year to date already. You know, it definitely allows us to have that further conversation with the SPL partners that are already in the negotiation phase and or those customers that are looking to, you know, transition to the clinic. But, you know, I want to take a step back here for a second in the sense of if you look at how we built our business development team over the last few years, and really over the last six, seven years even, and we're having more traction now, you know, the relationship we have with our customers really starts off in the early research, right, where we're with them oftentimes for, you know, for nine months, 12 months, a year and a half, you know, working in the early research. helping them to optimize their process. And when they're ready to get into the clinic, that's when we enter into those negotiations. So CashJet gives us that ability to have those continued discussions and gives us the ability to really help us with our increasing pipeline for SPLs. But these relationships that we have is not just relying on our approval of a commercial product. It's really relying on the team that's built here over the last few years and that scientific relationship that we build with customers from research all the way through post-development into the clinic. Hope that answers your question, Jacob.
spk01: Thank you. One moment for our next question. Our next question comes from the line of Dan Arias from Stiefel. Your line is open.
spk03: Good afternoon, guys. Thanks for the questions. I just wanted to ask a follow-up question on Cast Jevi. And in doing so, I think I'm probably just asking a broader question about the way that these commercialization events that your SPLs benefit you now that we're in the early days of seeing that play out. I mean, obviously you have the royalty revenues on the sales of the drug, and I know you've said you don't have enough information there to make a call, which seems fair. But to Jacob's point, I mean, I'm just curious about the general ramp up in instrument utilization and activity that takes place at Vertex or CRISPR or wherever. once they move into patient treatment mode. I mean, it seems like that should go up as they make more product post-approval, but is that true? Is there a way of thinking about that? It would just be kind of helpful to understand the way that the model could be impacted when we think about these approval successes.
spk06: Yes, yes. So, Dan, thanks for that question. Great point. So, obviously, you know, we don't want to speak ahead of Vortex, but You know, as the patient enrollment increases, as more patients are screened, and then eventually a few, absolutely, right? So we'll see that trajectory that, you know, what we hope is the hockey stick for adoption of Cash Chevy, which then increases the revenue that we have on the back end as well. So, you know, obviously our net sales are, you know, our percentage of the back end is based on the net sales of Cash Chevy, and that would be for any commercial product that's approved that utilize our system. So yes, you can expect that ramp. We can't speak to the numbers as to what the ramp is because we'll let Vertex speak to what they anticipate being the forecast for cash service sales. But that's correct. I mean, as we have more patient adoption, you'll have more utilization of consumables, more utilization of our instruments, which adds to that recurring instrument license fees that we have on an annual basis. So I hope that was helpful, Dan.
spk03: Yeah, it is. Okay. And then just as a follow-up, where do you think we are when it comes to the drawdown on the PA inventory level? That's obviously been a factor. It seems like there could maybe be a little bit more visibility there than just say capital raise activity or pipeline progression. So just curious if you think that there is more visibility there and if that's an element that maybe is looking a little bit better as we think about the next couple of quarters.
spk08: Thanks, Dan. This is Doug. So I think with respect to, you know, inventory drawdown, I think a lot of that was completed last year. I certainly don't want to get ahead and speak too much about a Q1, but I think we're off to a reasonable start this year. We are seeing, you know, some reasonable activity, particularly from SPL partners on pull-through. And so I don't think that we're going to see, I don't think we have that same issue that we had last year about folks really working through inventory that they have built up in previous years.
spk01: Thank you. One moment for our next question. Our next question comes from the line of Matt LaRue from William Blair. Your line is open.
spk07: Good evening. Sort of just following up on Dan's question there. I'm thinking about the cadence throughout the year. Most companies in this space have pointed to a much more back half loaded year. you typically have done about, I think, 43% of total revenue in the first half of the year. So just wondering if the split you're anticipating is any different than your historical level. And then if there's any discrepancies from a instrument versus a PA utilization perspective, particularly early on in the year that we should be thinking about.
spk08: Thanks for the question. This is Doug. So the way we've set our forecast for the year, we're not expecting any significant seasonality here. So in terms of back weighting versus the front of the year, we're not expecting any major seasonality here, if you will. Typically, there have been reasons why Q4 usually is a little stronger. You have people getting to the end of the year, needing to deploy budget. But what's clear for us, and maybe this speaks to the conservative nature for how we set guidance this year, there's absolutely no sort of recovery built into our forecast, right? This is the current market conditions. We're basing PA utilization for our guidance year based on where we sort of came out of 2023. So I can't speak to how other companies set their guidance, but we certainly have not baked in any component that requires, you know, the industry to, you know, significantly improve the macro environment for our client base this year. If it does happen, that represents the website.
spk07: Okay. And then just on VLX, you know, obviously that product was launched in fall of 2022, you know, sort of on a beta basis. And so it's been out there in the market with select customers for, you know, some time at this point. You're sort of referencing – it does sound like going back to the drawing board, at least sort of reevaluating applications and commercial approaches. I'm just wondering what particular you think needs to be tweaked or added or subtracted to make that product, you know, find the right market fit.
spk06: Yeah, no. So, absolutely. So, this is Myers. Obviously, it's not tweaking. We're taking an approach in the sense of very similar to what we did in the cell therapy space, right, which is when we entered the cell therapy space, we truly took the time to understand the application needs of all of our customers, right? And so we're doing the exact same thing in the bioprocessing space now. We're working with a few early adopters, truly understanding where is the utilization of the VLX going to show the most promise in terms of the applications, you know, for which cell lines and how much, you know, in terms of the production needs are going to be needed for the VLX. So it's not tweaking, right? So the engineering on the BLX really, it's something that when we launched it at the end of last year, we were able to showcase the ability to produce, transiently produce protein at a significant amount. Now it's ensuring that we're working with CERN early adopters where we truly understand the applications that will allow us to launch into a much bigger market. So I wouldn't say tweaking. It's more learnings from our customers, just like we did in cell therapy space, And it's more learnings of the market itself to understand when we do more bus launch, how do we ensure that that happens in a fashion where we're no longer working with early adopters. Now we're working across a vast spectrum of customers. So it's not tweaking. It's really understanding the market more than we have currently.
spk01: Thank you. One moment for our next question. Our next question comes from Mark Massaro from BTIG. Your line is open.
spk04: Hey, guys. Thank you for the questions, and congrats on a good start to the year with the new SPLs added. I wanted to start on guidance. And, Doug, I know you mentioned that your guide does not assume any improvement or any end market improvement. I just want to double-check that you're likely referring to improvement in the capital raising environment. And then related to that, I believe you guys indicated that the capital raising environment is starting the year a little bit better than you expected. Could you please elaborate on that and maybe any comments on, you know, public companies versus private companies, anything that you're seeing would be helpful.
spk08: I want to take that number short. In terms of capital markets, let me go back to the first question. When I said improvement in the macro, I guess we really are talking about the capital availability for our customer base. At the end of the day, we can't untether ourselves from the market we serve and provide enabling technology to. As things are strong there in terms of having access to capital, then that'll help us. Last year, capital wasn't free-flowing as much as it had been, and you had companies rationalizing their pipeline. You had people pausing some things, and I think that there is some signs of life here. We can talk about some specific financing that we've seen in the market, but I think you can certainly see what those were. I am mostly referring to public companies. We do know that private companies will have access to capital, but I think The way this typically works is you need some of the public companies to have some better results, to do some financings that are viewed as successful by market participants, and then perhaps that rolls down to some of the private companies. So I think it's predominantly been the public companies that we've been able to observe specific announcements regarding significant financings for companies in the space to start the year. We did not build into our forecast that the markets will improve. And while we've got some reasons to be encouraged based on what we've seen, it's still early days here in terms of how things are going to roll out for the year. And so, again, we've taken a very conservative, trying to set an achievable goal for ourselves with this guidance to make sure that we are, again, forecasting pull through, for instance, based on what it looked like last year. That's just, I think, the best way to do it. Obviously, we want to be in a position to achieve what we set out to do this year.
spk04: Okay, great. And then maybe just another guidance clarification question. Obviously, 2023 was a tough year. For the full year, your core bids was down 25%. It was a little worse than that in Q4, down 32%. So, you know, for 2024, for you to guide flat to plus five obviously does imply an improvement in trend. So, you know, I guess what I'm trying to get at is what informs your assumption that you can come in flat to up this year? Can you just give us a sense of if you think a lot of the, you know, the business will come in through PAs versus placements? You know, related to that, I think you placed 67 new systems last year versus 114 in the prior year. So, just give us a sense for how much of this growth, or flat to slightly up, will come from PA consumption versus new system placements.
spk08: We typically, and we're not going to today, break down that guidance in terms of the specific components. Let me just remind you how we build this up because again, I think it gives you some comfort or some understanding of how we're thinking about the market and how that might impact utilization of our platform. So the three main components of core revenue are the leases for the instruments that are under the SPL arrangements. It is the instrument that sales to the other markets we serve. And of course, the PA revenue is from you know, is a pull through that we're basing that analysis again on where we ended the year. We're looking at specifically what's the rate of PAs that we were selling at the end of the year. And we said, let's be conservative. Let's look at that and roll that forward for 2024. Now the instruments placements for 2024, we're building that up from specific identified opportunities that comes in through, you know, our commercial team that we model out to determine what the likelihood of any particular opportunity coming through, again, using what we think are improving assumptions about what's going to hit. And that's how we build up this revenue. So I can't specifically say how much of this is PA utilization, but I can say that the PA utilization that we're using to build that number up is based on where we came out through the end of the year. And I recognize 2.4 was tough on a year-over-year basis, It was certainly better in many ways for the Duke than the third quarter.
spk01: Thank you. One moment for our next question. Our next question comes from the line of Steven Ma from TD Callen. Your line is open.
spk05: Great. Thanks for taking the questions. On the SPL numbers in 2024, I don't think you guys are guiding to a number. how should we think about new SPLs in the year given, you know, your historic three to five per year, you know, especially that, you know, you're kind of already in that range with three already year to date. And then also given your comments that the SPL pipeline is robust.
spk06: Yeah, so obviously we signed three this year. You know, we're confident in what we've done in the past, which is that three to four, three to five number. You know, the three this year, doesn't mean that we're signing three every quarter, right? So the way it normally works on these SPLs that I was mentioning earlier is we're in these relationships oftentimes for, you know, for, you know, nine months, 12 months, 18 months with a customer all the way through. Sometimes we have a bolus where by the time that we've done the process on the work for that customer where they're ready to become, to go into SPL negotiations, you might have a bolus where you have a few customers that are, you know, signing around the same time. But overall, we're comfortable with the pipeline we've built that we can maintain the historical trend of that three to four, you know, plus number on an annual basis. And that's where, you know, that's where we're getting to right now as well. So, you know, that three number I wouldn't take as three every quarter. But it's a healthy number, and we're comfortable with the pipeline.
spk05: Yeah. No, no, understood. And then maybe, Mahir, you know, you talked about $1.9 billion in potential value from the SPL partnerships in your portfolio. you know, up from $1.5 billion last year. Has there been any internal changes to your NPV calculations? You know, I know interest rates are trending down. You know, maybe there's a better approval and regulatory environment, you know, which might improve probability of success and therefore your discount rate. You know, how should we think about it? Have there been any changes or are you guys being conservative in your calculations? Thank you.
spk08: So to be clear, you know, that number that you referenced is not a risk-adjusted number. So it's not discounted. It's not risk-adjusted in any way. You know, how we think about NPV of our programs, would you factor in those factors? But the metric that you're mentioning, Steve, does not include any discounting or risk adjustment. It's strictly what is available to us under the SPL agreements should every item in there hit.
spk01: Thank you. Once again, as a reminder, that's star 11 for questions, star 11. One moment for our next question. Our next question will come from the line of Matt Hewitt from Craig Halem. Your line is open.
spk00: Good afternoon. Thank you for taking the questions. Maybe I'll follow on one of the questions a couple ago. I think you were acknowledging Q4 was tough, and everybody knows that it was tough, but what are you seeing so far in the first quarter? Obviously, the funding seems to be improving a little bit, but are you seeing that slight improvement in funding translate into some slight improvement in the PA utilization in the discussions that you're having with potential SPL customers?
spk06: Yeah. Hi, Matt. Let me take that before. So we are seeing that stabilization that we saw in Q4 really materialize in Q1 as well, right? And that's kind of the funding environment that's also been, you know, from our SPL customers that we believe will begin to trickle down into non-ASPL customers. You saw a few of our customers raising over $100 million recently in public offerings. So we're seeing that stabilization. In terms of the pay utilization, I'll let Doug speak to that, but obviously with the stabilization, we're hoping that that continues throughout the year. Doug, did you want to comment on the videos? Sure.
spk08: I mean, let's just talk about where we are at Q1. You know, first off, just to recall what we were talking about in response to a previous question is we're not really anticipating any seasonality here in the cadence of the business. So there's nothing built in here that says, hey, as long as, you know, we have a big second half of the year, we're going to be able to achieve what we set out to do here. So, you know, given that, you know, we are sitting here, you know, a couple weeks out from the end of the first quarter, we feel good about where we are today. We think we're on track.
spk00: Got it. And then maybe a separate question. Your partners have talked about it's a multi-step process with Casgivvy, the patient enrollment, the cell recovery, all of that. And it's multiple months with each of those steps, hence, I guess, the desire, the need to be conservative, at least this first year. But is it your expectation as we get through and as your partners get more comfortable with that process that that timeline shrinks and so maybe you get a more normalized pattern of patient enrollment to patient treatment and the timeline shrinks so maybe 25 and beyond become more normalized, if you will?
spk06: Yeah, let me take that one, Matt. So the timeline won't shrink because that's the patient journey, whether it's It's now or in 25 or 26. But what will happen is as you have more patients that are having infusions, it will normalize in the sense of you have more patients now that are in any given month being treated with Cashevi. So it's not necessarily a crunch of the timeline. It's more of a normalization effect. in terms of, you know, the usage, the pay usage for us, you know, based on how many, you know, patients are being dosed, which we are hopeful, you know, that over the next, you know, year and then few years, that you'll have more of the option to catch that, that we have more patients being treated on a monthly basis. So I hope that answers your question, Matt.
spk01: Thank you. That's all the time we have for questions today. I would now like to turn the call back over to Maher Masood, CEO, for closing remarks.
spk06: Thank you, everyone, for participating. We look forward to speaking with everyone on our Q1 call.
spk01: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.
Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-