MaxCyte, Inc. (MXCT) Q4 2021 Earnings Report, Transcript and Summary

Thank you for standing by. And welcome to the MaxCyte’s Fourth Quarter and Full Year 2021 Earnings Conference Call. [Operator instructions] Please be advised that today’s call maybe recorded. I would now like to hand the call over to Sean Menarguez, Investor Relations. Please go ahead.

Thank you, Latif. And good afternoon, everyone. Thank you all for participating in today's conference call. On the call from MaxCyte, we have Doug Doerfler, Chief Executive Officer; and Amanda Murphy, Chief Financial Officer. Earlier today, MaxCyte released financial results for the fourth quarter and full year ended December 31, 2021. 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 in any forward-looking statements due to a variety of factors, which are discussed in detail in our SEC filings. The company undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will turn the call over to Doug.

Well, thank you, Sean. And good afternoon, everyone. And thank you for joining MaxCyte’s fourth quarter and full year earnings call. I'll begin with a discussion of our business and operational highlights during the quarter, followed by a detailed financial review from Amanda. We will then open the call for questions. I'm very excited with our team's performance in 2021. As we became a NASDAQ listed company, and continue to deliver on all of our financial and strategic objectives and our plan. MaxCyte’s platform remains the premier cell-engineering technology supporting the development of advanced cell therapeutics. And we continue to invest in our people and capabilities at a measured but healthy rate. Amanda will provide more details later in the call. But I know that we generated very strong fourth quarter and full year 2021 results as outlined in the press release published earlier today. Driven by robust performance and our core cell-engineering business to both cell therapy and drug discovery customers. Fourth quarter revenues were $10.2 million, up 19% over the fourth quarter of 2020. We saw very strong growth in our core business with growth in revenue to customers in cell therapy of 43% and drug discovery of 32%. For the full year of 2021 net total revenue was $33.9 million, representing growth of 30% compared to 2020. Our core instruments and disposables and cell therapy and drug discovery grew 37% in the year ahead of our historical five year CAGR of approximately 25%. Our installed base of instruments both sold and leased, grew to over 500 by the end of 2021, compared to over 400 at the end of 2020. During the year, we also recognize $2.5 million in pre-commercial clinical milestone revenues from our Strategic Platform License or SPL commercial partners. As we have previously indicated, we take the confidentiality of our partnership agreements very seriously. So we'll be unable to answer any specific questions related to our SPL partners and their respective development programs. However, I can say that we are generally excited about the progress our partners have been making in the clinic over the past year, we continue to see additional SPL programs enter the clinic and have seen our existing clinical SPL portfolio progress in the later stages, including pivotal trials, suggesting that we may see our first commercial product as early as 2023. We are extremely proud to be able to support our partners and their efforts to bring advanced therapeutics to patients. We have continued to see our partners invest in SPL cell therapies and expand the scope of their research including new cell types, modalities and indications which if successful, would be part of MaxCyte the long term. In addition, our value continues to be further validated by our expanding customer base, including the ongoing success we have had in signing SPLs with four new SPL agreements in 2021. And one agreement with Intima Biosciences signed in early 2022. We now have 60 SPL partners covering more than 95 programs, of which more than 15% have entered the clinic. This compares to our last update in January 2021 of 12 SPLs covering over 75 programs, of which more than 15% have entered the clinic. The total pre-commercial revenue potential from our total SPL programs is now greater than $1.2 billion, up from $950 million at the end of 2020. In the near term, we are optimistic about the potential for our SPL partners to generate meaningful revenue from both the Research and Production progress, as well as clinical milestones over the next 12 to 24 months. Our partners continue to achieve both scientific and clinical success, particularly in moving their next generation product candidates into pivotal trials. We also see the potential for several new IND filings by our existing SPL partners for novel ex vivo engineered cell therapies this year, Amanda will share more details around the progression of potential pre-commercial milestones that we expect to see over the next few years. With ongoing investment in the ex vivo engineered cell therapy space, we continue to see strengthening of our SPL pipeline across a variety of geographies, cell types, approaches, and indications and expect additional SPL partnership announcements later this year. The economics of our recent SPL partnerships remain comparable to prior partnerships, representative of the value MaxCyte brings to the relationships and the customers commitment to a long term partnership. Much of our focus in 2021 was investing in the business and refining our strategic plan. One of our investments has been in the VLx instrument which we released under the ExPERT brand in 2021. After alpha testing the product for several years with select customers and receiving valuable feedback, the VLx has entered the marketplace and we believe will be a disruptive technology in a large scale bioprocessing applications. In 2022, we plan to work with several beta customers on the ExPERT VLx to build up applications data to support our expansion into the large scale bioprocessing market and we have been encouraged by the interest we have seen from customers participating in the VLx beta testing program. While the market expansion opportunity for the VLx in the large scale bioprocessing applications will take time to evolve. We are encouraged by the progress to date, and look forward to updating investors on the evolution of the VLx product roadmap over time. Finally, we launched three new processing assemblies or single use disposables in 2021, which continued to strengthen the core business for the full year and particularly in the fourth quarter. We are also investing in manufacturing and process development as our partners move closer to the commercial launch of therapeutic products. We are on track with our plans to move into a new facility this year, which more than tripled our manufacturing space and expands our process development capabilities. We also continue to further insource key elements of the manufacturing process, particularly around processing assemblies. Additionally, we are investing meaningfully in sales and marketing and made substantial progress in 2021 scaling our commercial organization including our field scientist team, we are hiring at a strong pace and remain committed to maintaining MaxCyte’s strong culture of excellence. We are also excited to announce Cenk Sumen join us earlier this month as MaxCyte’s Chief Scientific Officer, Cenk brings deep experience in technology, applications and platform assessments, the development of commercial partnerships, and leading collaborations to accelerate scientific and technical innovation. As we look more into 2022, we expect MaxCyte to continue to grow its team across most areas of the organization, particularly in research development and sales and marketing. In closing, we have had an excellent 2021 as we continue to execute our financial and strategic goals. We are very excited about our opportunity going forward, particularly in the cell therapy market, and believe we are making the right investments that drive growth across the business. I will now turn the call over to Amanda to discuss our financial results. Amanda?

Thanks Doug. And good afternoon, everyone. Focusing on the first quarter as Doug mentioned, we're happy to report we realized record revenue and growth in our core business in the fourth quarter. Sales in cell therapy customers and our core business grew a robust 43% over the same quarter last year. Both sales and drug discovery customers also grow strong 32%. We saw broad growth across the business with strengthen insurance sales to both cell therapy and drug discovery customers, as well as processing assemblies, in part aided by the new Processing Assembly launches that Doug has mentioned earlier. We did not recognize any SQL program related revenue in the fourth quarter of 2021. Although we recognize $2.5 million for the full year of 2021. We do appreciate however, the need to provide more transparency on our program economics near term and long term, so I’ll provide more details on that front a bit later in the call. Moving down the P&L and looking at the fourth quarter, gross margin was 88% in the quarter versus 89% over the quarter prior, the decrease in gross margin was driven by the lower SPL program related revenues excluding those dynamic gross margin was relatively unchanged. Total operating expenses for the fourth quarter of 2021 were $14 million compared to $10 million in the fourth quarter of 2020. As Doug mentioned, our current strategy is to continue to make meaningful and grow investments in R&D and sales and marketing to take advantage of the many opportunities we see to accelerate organic growth over the next few years. The increase year-over-year was primarily driven by increased headcount across all areas of our business, as well as an increase in stock-based compensation as we outlined in the press release. Ultimately, we came at 2022 with a very healthy balance sheet, with total cash and cash equivalents and short term investments of $255 million as of the end of the fourth quarter and no debt. Moving to our outlook for 2022 as we outlined in our press release, we expect revenue from our core business, which includes sales of instruments and disposables to cell therapy and drug discovery customers as well as lease revenue to our cell therapy customers to grow between 22% and 25% over the prior year. As I've mentioned, we remain optimistic about the prospects for business and believe our SPL partners are well capitalized in 2022 and into 2023. In addition, the business momentum we saw in 2021, continued into the first quarter of 2022. That said, we believe we've captured a more prudent outlook in our guidance, given the current broader macro environment and ongoing fluctuating COVID dynamics. Turning for SPL program economics, as we've discussed in our previous call, and also in discussions with investors and analysts. The timing of our SPL revenue recognition is predicated on our customers’ clinical and regulatory process and FDA decision making, which obviously we have limited visibility into. That said, we do you appreciate the need to provide some core visibility and transparency externally. Over the past year, we've seen strong progression in our customer pipeline and an increasing number of potential milestones added into the milestone stack as we add more SQL partners. We expect the timing of milestone revenue continues to be lumpy over the near term, quarter-to-quarter as our SPL pipeline continues to mature. We do however, based on current information expect 2022 SPL milestone revenue of approximately $4 million. In addition, to help provide some context on the SPL milestone revenue opportunities for MaxCyte over the next couple of years, we've added an additional slides to our corporate deck, where we wanted to call your attention to which can be found in our website@www.maxcyte.com. This new slide number 14 attempts to provide a snapshot of how milestones have trended over the past five years in terms of number and phase and how we expect them to trend through 2024. Over the past five years, we've received approximately 20 milestones which have been comprised of early stage milestones such as IND filing in phase one, as you would expect. Looking forward however, based on the information we currently have, we see the total potential of approximately 50 milestones, pre-commercial, which is almost three times as much as we had over the past five years. These milestones are also increasingly related to later stage development. We estimate about a quarter of those 50 are pivotal or later and 40% are phase one. These numbers are based on our current SPL partnership and don't include any future SPL agreements we may sign. As Doug mentioned, there are several opportunities in front of MaxCyte and we continue to plan on making necessary investments in R&D and sales and marketing to capitalize it as opportunities. So we expect those investments to increase throughout the year in 2022 as we see the full year impact of headcount added in ‘21 and continue to invest in those areas and plan to. Now I’ll turn it back over to Doug.

Thanks Amanda. In summary, we remain excited about the opportunity to lead the industry forward as the premier cell-engineering platform technology, supporting the development of advanced cell based therapeutics. We were pleased to report strong fourth quarter and full year results as well as set our outlook for 2022. MaxCyte remains well positioned for growth and we are excited about the opportunities ahead. I want to take this special opportunity to recognize our entire global team and Board for their full commitment to providing unparalleled technology, products and support to bringing the new generation of cell based products to patients, providing them additional treatment options. With that, Latif, I like to open this up for Q&A.

[Operator Instructions] First question comes from Jacob Johnson of Stephens.

Hey, good evening, or afternoon. Maybe Amanda following up on the comment you just made about the progression of SPL as customers ramp and thanks for the new slide, I guess thinking about it from the core business perspective, can you just frame up what the scale up for these customers looks like in terms of the number of instruments and the amount of consumable? Somebody's moving into pivotal kind of needs and what that looks like, potentially, as they move into commercialization, just kind of what that scale up in kind of the core business looks like from those customers.

Yes, I'll take a first stab at that. And then I’ll turn it over to Doug for more comments, I mean we haven't really given that level of context at this point, and obviously, it's variable depending on the approach and indication and all that type of thing. What we have said though is that we've consistently seen the same trends meaning from a preclinical perspective, we tend to see a lot of usage with our lower scale processing assemblies, just because obviously they're working on optimizing and things like that. And then as you work through the clinical trial process, you tend to see a bit of a dip from a unit perspective, because typically, the phase one, trials are smaller, again, depending on the indication, it can be variable there. And then ramp over time as the customers move through the regulatory process into pivotal and beyond. So we've kind of laid that out. But that's pretty much what we've given at this point. Doug, I don’t know if you have anything else to add there.

Yes, I think there's an algorithm here we're trying to build and it's still low numbers, Jacob, but certainly auto versus allo, and its auto or both of them, it's going to be heavily manufacturing sites they have. And that would also be driven by how many locations they're running clinical trials. Some of our customers and partners use ballroom type manufacturing processes where other US manufacturing trains. We're seeing also, as customers get more comfortable with our technology, and they put products into the clinic, they add more preclinical and non-clinical programs into their own. So we end up with additional product sales for that purpose. So I don't think there's any real clear algorithm we've been able to build, I think we're still building it. But obviously, they do increase over the course of the relationship with the partner.

Thanks. Thanks for having helpful context. And then on the kind of beta testing with VLx. I think there's a wide range of use cases for that instrument from MAPS, viral vectors, and maybe most interesting, the allogeneic side of things. Can you just talk about in those kind of areas where you're seeing the most initial interest understanding that it's pretty early and names for VLx?

Yes, I think it is still pretty early. I think that the one that we're focused on initially would be the MAP production because I think that there's immediate need in the marketplace for that abroad. I think it is abroad tam expansion opportunity for the company. And we do quite a bit of that in smaller scale with our STx today, so it's a natural progression for our company, from our partners who want to scale the STx up the larger volumes. I think there's still work that has to be done in the VLx application. The viral vector are still biology. I mean, one of the reasons we brought, Cenk join us was to help with kind of across the board and really figure out what sort of use cases we had to ensure we had in place in order to commercialize that in the proper way, the way the MaxCyte likes to do that. And that's I think I've mentioned in prior calls, there's quite a bit of work in making sure that this technology, although it's very disruptive, it does require significant pre and post electroporation, engineering work that process engineering work that has to be done. And that's one of the reasons that we're investing in process development as a company moving into a new facility so that we can better mirror what are our beta testers are using the technology for.

Our next question comes from Julie Simmonds of Panmure.

Thank you very much and thanks for the results, guys. Just a question following up on the VLx as to whether you have any idea as to what the business model for that is going to look like? Yes, is this just going to be another licensing model? Or is it going to be an outright sale and it is consumable type of model.

Hi, Julie, so part of part of the beta testing is that really spend the time testing that model, I think it will vary based on the application and vary based on the value we bring to the customer, I think it's fair to say that our mindset around this has been to work closely with partners and understand where the pain points are, and work to solving those and then sharing that upside with them as we do that. So I think that same mindset will, I think, will be valuable for the company and our partners, frankly, as they see the long-term opportunities for this technology.

Excellent, thank you. And just on the expenses side, and clearly you said we're going to step up since your NASDAQ IPO as expected. I mean how much more on a quarterly basis do we expect that to go up? I mean, can we use Q4 as a sort of indication as to what it's like going forwards? Or is moving to the new site? And the continued recruitment going to mean that we're going to see continual setup going into 2022 through 2022?

Yes, I'll take a first crack at that. I mean, I think, as you were, as you mentioned, we see quite a bit of opportunity from investment perspective in terms of driving further growth in cell therapy. And so we're investing quite a bit in headcount, particularly in R&D and sales and marketing. So I would expect that to increase just because obviously, we have hired quite a few people. And then you'll see that full year as I was saying, the full year impact of that in 2022. And then in addition we're continuously hiring as well. So we're not giving specific guidance, so to speak, but that's how I would think about it in terms of investment.

Our next question comes from Paul Cuddon of Numis.

Hi, Amanda. Sorry, is that working now? Okay. Very good. Yes, good to hear from you both. And congratulations on 2021. I was just hoping for a little bit more color on sort of growth within cell therapy, in particular, I mean to any major differences between drug discovery actually between capital sales and the processing assemblies and the leases. And with over 500 instruments in the install base now. Are you finding customers are sort of managing and happy with the machines they've got? Are you having a little bit more support so alongside those to keep them running smoothly?

I'll answer the last part of that, Paul. I mean, these instruments are built to last and there's very little work that has to be done to have them operational. So we really don't have that as an issue. We don't have to really invest much to do that. I don't, we can't give specifics, but I will say that the business is performing rather just really well across the board, leases, product sales, disposables in every aspect of business has really been particularly strong.

Okay superb. And in terms of applications we've seen the importance of your technology for cell therapy, we've spoken about viral vectors and potentially sort of bio manufacturing in the past, I think this year has seen sort of quiet for the last few years, serology has become quite lucrative. There is sero virus kind of assays sort of happening within drug discovery. So I'm just wondering whether there are other kind of avenues where you're finding sort of early interests within the ExPERT system that are emerging that could complement where it's historically been very strong.

Well, I think in two areas I can comment on directly, the one is that we're -- there's a lot of work that's being done on identifying new pathways and sales, right for engineering and new cell types. And we did the Intima deal, which is tile cell and then we're knocking down the cyst pathway, which is apparently an important one. So there's a lot of basic research, I think that's being done or translational research is being done in the cell therapy space. So we're seeing a lot of interest in that. In the drug discovery side, on not bioprocessing, but small molecule drug discovery, there's still quite a bit of early stage work that's being done to identify new ion channels, new ways of creating IPSC cell lines for the identification and screening of targets for instance. So that's an area that we keep an active part on but so, yes, it's just -- it's across the board. What we want to be careful of and I think we've talked about before, is we don't want to get pulled into the academic research part of this of the life sciences business, we really want to focus our attention on more business based commercial directed in clinical directed than eventually commercials only directed therapeutic development.

Okay, excellent. And just finally, on the I think I've got slide 12 of the corporate presentation, the example SPL NPV, you've got six programs per agreement, launching one year, two fail in preclinical, four enter clinical, one reaches commercial. Okay, so I mean that would be sort of a typical sort of example within the cell therapy applications that you're in, and the weighted average NPV of $85 million. I mean that would be sort of a standard calculation that you've run.

So, Paul, let me take the first step. So we did -- so that was part of the issue was also in S1. And what we were trying to really do there is not give a specific or rather given example SPL, so of course, each individual partnership is different. And there's different number of programs that we're trying to get some perspective on. If you apply some level of clinical risk to an SPL, which roughly is average of six programs per partner, but obviously, that in reality varies. And then just thinking through, assuming one gets to commercial, and then the other has dropped out, you can obviously apply whatever clinical risk you feel comfortable with. But we're just trying to provide an example of what each partnership could be worth and in terms of pre-commercial milestones, which are actually pretty consistent across the partnerships, given they're more related to regulatory timing, and events versus the commercial side, which is I think what you can see from there is that it could be meaningfully higher, but obviously more variable because you're then talking about indications and that type of thing. We did only use the first five years of theoretical commercial revenue in that analysis for that perspective, but it was just way to give an example of the value potential from a revenue perspective.

Our next question comes from Daniel Arias of Stifel.

Hi, guys, thank you for the questions. Doug or Amanda, I want to just ask about drug discovery revenues. If I look back the last couple of years you've been in the pretty tight $7 million to $7.5 million range for a while, but you did step up this year to closer to $8 million or to over $8 million. And I remember you talking about the VLx system is having a pretty good opportunity in drug discovery. In fact, I think you just mentioned it on this call. So as we think about that, I mean, is it likely that this was a step up that we're seeing here and with VLx having a nice opportunity in that portion, that we could start to see the drug discovery revenue kind of consistently tick higher in the $8 million to $9 million range going forward, maybe not this year, as much, but 2023.

I'll leave Amanda to talk about the specific numbers. But as I've been, as we've been talking for the last couple of years, we’ve recognized that there's a couple of issues going on. One is that the drug discovery market is a huge opportunity for us and we've been able to show I think, more value to our customers on the cell therapy sites, I think that there has been more attention being paid for the cell therapy group, we've also had the opportunity, since we had more capital really start to expand out our commercial team. And part of that expansion is providing us the ability to go a bit deeper into these drug discovery and bioprocessing partners like, I think that was and that's what you're seeing as a result of that concerted effort to really rebuild that business from where it was several years ago. And so not sure we're going to land from a numbers perspective, but the folks we're bringing in have, most recently have come out of that world as well. So we're trying to really balance the cell therapy opportunity with the bioprocessing opportunity and the drug discovery opportunities. Hopefully, that helps.

Yes, just a couple of things. And so as we mentioned, we introduced some new processing assemblies, which I think benefited the drug discovery part of the business in terms of multi well PA that sort of help lower this transaction, the per transaction costs, I think that's been a driver. From a VLx perspective, we're, as we mentioned, seeing very strong interest in the beta customer perspective. But again this is a new market for us in terms of unnecessarily new applications as we do this with some of them with former customers now, but certainly need to build up the use cases and the supporting data for those over time. So I think what we've been saying and continued to say is that we're very excited about the market opportunity there, as Doug talked about but again, this is kind of a longer term two to three year type of revenue driver for the company.

Okay. I mean, I don't want to -- I don't mean to be overly picky on the numbers, per se, because it's a million or so here. But I guess the essence of the question was just, do you think that drug discovery, the trajectory for drug discovery can start to tick up a little bit as you work through some of your new products? And as you and Doug's point just the opportunity set in front of it such that in a couple of years, maybe you do find that the double digit million number, you don't have to endorse the number, I guess I'm just thinking about whether I should start to be a little bit more incrementally positive on where that line goes.

Yes, I mean again, we're not giving specific guidance by market, but I think we definitely are encouraged by what we have seen to date in terms of the adoption of these new PA, as we mentioned, there is since sort of, yes, obviously, with the growth and the growth side of it, there's a comparison dynamic, but I think obviously, where the run rate now that we have is not with the with the VLx in the large scale markets. So that's sort of our current business and the team continues to look at new PAs that can help continue to meet customer needs. And I think we saw success there on both sides of the equation this year and this quarter, so especially this quarter, so I'll just going to leave it at that.

Yes, okay.

Just only thing I would add to that, Dan, is that we, I think we mentioned that we did see some compression on the drug discovery side because of the pandemic and the inability to really get into some of these bigger companies that they weren't operating at full capacity. And I think you're seeing now the big pharma companies, the big biotech companies are returning, coming back in a big way. And I think that's going to be helpful for that segment.

Yes, that is definitely good to hear. Okay. And then Amanda on the gross margin line, is there anything you would call out from a cadence perspective over the course of the year just given the impact that milestones and royalties have there?

Yes, look, outside of the royalty, the milestones, sorry, dynamics, we're seeing, it's pretty consistent. It may then review some puts and takes there. But it's been fairly consistent over the past several years, the quarterly cadence of the milestones is really hard to pin down, as you can imagine, just given it's about their control rate, it's our customers regulatory timelines, and FDA decision making, which is pretty hard for us to pin down outside of that, I think, we expect gross margins to be fairly consistent. I don’t know, Doug, if you have anything to add there, just all else equal with their current business anyways.

No, I mean the band is pretty tight. If you look at it, it's one or two points, right. So it's, so I think Amanda hit it, I think we're comfortable with kind of that level of those margins in the business. And as I also mentioned, I think the milestones are going to help push that gross margin number up a little bit. And as we become more basic in manufacturing, and certainly earlier days where we're manufacturing more SKUs, you're going to see some erosion, a little bit of erosion of gross margin, but I think they're going to offset each other.

Our next question comes from Matt Larew of William Blair.

Hi, good afternoon. In terms of the future market opportunity, I think, at the time of the NASDAQ IPO, you characterize an SPL pipeline around 50. And I think growing to somewhere like 130 or 140, over the next five years, just curious if there's been any change to those thoughts. And then I guess part two would be just thoughts around your ability to participate in those opportunities. So more of a competitive question. I know there's been a couple of recent competitor product announcements, and maybe just get your take on that.

Well, let me just start, I'll take the first part in terms of the market, and how we calculated that and then turn it over to Doug. So that slides in the deck. And essentially, it was sort of a point in time analysis where we looked at the pipeline. And we said, right, yes, obviously, we don't, from an SPL perspective, we partner with companies. So we looked at the pipeline, that's in our current -- that was in our current market where we're seeing a lot of success. So IO and inherited disorders. And we said, all right, how many of those should be SPL opportunities, and that's what we came up with the 50. We have seen incremental interest outside of those markets, as are indications so auto immune, as an example. And then when we factored in the forward five year growth, we made an estimate around the impact of current investment and adoption of non-viral technology. So that was really our take at the time I think, as we're continuously seeing increased complexity, right in the market in terms of cell type and engineering. Or how much engineering at the cells companies are doing. So that would all sort of point to increase adoption of other non-viral and non-viral delivery technologies. I think the other thing I would say there is that we're also seeing interest outside of kind of the US and Europe as well. And so that wasn't factored into that analysis. So we haven't updated that, honestly, since the IPO. But we're just trying to give a perspective. So I would say if anything, the market sort of are larger at this point. Doug, do you want to take the second part of that?

Yes, you comment on that and the second part of the question, right. So first off, strong cell therapy growth, if we're selling or leasing instruments into non SPL customers. That's a good indication of the strengthening of the pipeline of potential SPL customers, right because anyone who's acquiring the technology or licensing technology, they're licensing it for all the attributes that we had, and the benefits we provide to our customers. So that's using the baseball analogy, because hopefully, we'll start seeing some baseball again, that's the on deck circle for us. So we want to really make sure we've got a lot of people in the pipeline, a lot of companies in the Arctic Circle, so when they come up, for the SPL deals, we were -- we've got them captured. And so there, we just continue to focus our attention on capturing these companies at the early stage. In terms of competition, there's a lot of noise out there. But I think that we're not seeing that having an impact on our close rate, frankly. And we've often talked about kind of the four pillars of our offering, which is high performance of the system in terms of efficiencies, the flexibility, in terms of being able to use a single buffer for instance, and your pre-loaded library of validated cell specific products, I have to mention that's becoming a bigger and bigger issue with the CMC issues run FDA, the scalability is still key and is we stand alone in that aspect of with VLx, we've actually just extended the game by basically 10 times that the STx and GTx. And then the quality, it’s the cGMP, it's a single use disposables. It's a master file. And all four of those things, we excel in each of those four, and there's no one out there that can touch us any of those four. So yes, no, we're not going to be complacent, continue to push the envelope, but we're not seeing an impact on the business.

Okay, that's great. And then another year for strong instrument placement. Just be curious if you can give us any sort of color around instrument placement location in terms of cell therapy for drug discovery, or how many of those placements are driven by current customers scaling up their efforts versus new customers adopting a technology?

Yes, I don't think we can give any guidance on that. I do -- those things that we mentioned in the earnings call earlier that we're seeing an uptake in other geographies, which I think is quite important for the company, and I think quite important for the whole industry. So we're seeing the fruits of our labor in the setting up beachheads in Asian countries and throughout Europe, and the US is starting to pay dividends, it takes time. We're a small company, but I think you're starting to see kind of the flywheel effect as we put, as we build out our sales and marketing team, we build out our field application scientist, we're able to uniquely solve customer problems in locations that we couldn't really touch before we had the capability and capacity and capital to do so. But now we can do that. So I think we're going to see an increase across the board and the performance of the business.

Okay, thank you. Then the last one for me in terms of bringing more manufacturing in house, I guess. Could you remind us is the intention that at the conclusion, all PA assembly will be done internally, and how much at that point would still need to be in sourced in terms of components versus largely assembled internally?

Well, I think it's always wise to keep a balance of external and internal manufacturing, I think it's always prudent from a manufacturing perspective to have multiple sites at least be able to rely on multiple sites, if you run into an issue with either capacity or something would have happened to the site, right? So I don't see us putting all our eggs in one basket. We're not going to be basic in in injection molding for instance, we think that's better for larger companies that are out there, doing that on a daily basis. But what we're really focused on is making sure we have better control over all the components and better control over the assembly and final preparation of the products for our customers because what we want to ensure there's obviously some commonality amongst these different disposables, and we want to control them. And we'll be able to control better the mix of finished goods based on the ability to collaborate certain individual components. And so I think it's going to help us to build inventories become more flexible. And as our customers move toward commercialization, I think it's going to be even more important that we've got excess capacity in our manufacturing capabilities to support them. As you know, in the therapeutics business, there could be rather significant variations in terms of demand for these products. And we want to make sure that we're able to support that.

Your next question comes from Max Masucci of Cowen and Company.

Hi, thanks for taking the question. Congrats on the continued momentum in the business. First one, FDA released some new draft CAR-T product development guidance last week, this covers a range of topics the ideal time to implement manufacturing changes, call to action for better monitoring of critical quality attributes. But it's a comprehensive draft guidance, but from a bird's eye view, Doug, it would be great to hear your perspective, if you've had a chance to review it just in the context of your SPL business, and your non- SPL core business?

Well, sure, well a lot of the guidance is focused on CMC and manufacturing control, right. And so there's also been some comments about the ability to use information around certain manufacturing processes that could be eventually used for cross referencing for VLx, for instance, I think that bodes favorably for MaxCyte, I think there's also, I think, more interest in ensuring that the consistency of each of these processes is important. And that, again, you can manufacture the same product on the same instrument from one run to another. And then from one instrument to another instrument, and from one location to another location. And I think we've been working for the last couple of decades to make sure that we can do that. And so our sense is that we, this is a welcome validation of what we've been really focusing our attention on over the last at least decades to ensure that we can provide our partners with what they need to move all the way into the clinic and all the way through the clinic with our master file, I think we mentioned we now have over 40 clinical trials associated with it. So we feel like we're in the right -- we're doing the right stuff. We think also that guidance provides us with additional opportunities to build the business. Because what we learned, I think, we've learned with our partners that consistency and product characterization are important. And I think our company's really set up to look at new potential technologies and new potential solutions to these problems, as partners move closer to commercialization. And, again, we're working with as you've recognized with some of the leaders in the commercialization of cell therapy. So I think we've got a kind of an inside view of what's going to be important. So our sense with that guidance was a good validation, there's a really important interface between industry and FDA, whether that be through bio and or through arm or ISCC. And MaxCyte is actively involved in all those organizations to ensure that we can help to provide the standardization for the industry. So that's an investment that we quietly make and spend time ensuring that the industry is well supported by technology providers at MaxCyte.

That's great. Just a follow up there. It seems like FDA is nothing CAR-T developers to at least attempt to lock down manufacturing methods that earlier in development. So just curious of that would be that nudge or that urge from the FDA would be could spur a tailwind for some GMP grade closed platforms or GMP grade PAs in the core razor blade business and the PA portfolio is continuing to expand round out. And you do have I believe the three processing assemblies are being sold to both research and GMP customer. So, it would be great to hear if you're seeing that shift to GMP products occurring earlier in the process, and if that could be a tailwind.

Yes, I think our view was our customers have been getting involved with as early as we can provide you the same platform, the same product, the same electroporation settings, all the way through for IND enabling studies all the way through scalability. All the way through to commercialization. And so I think that does play well, I think we've been at the, not say the forefront, but I think we recognize the need and the opportunity. I think we've seized it. So I think we're pretty in good shape.

And next question comes from the line of Mark Massaro of BTIG.

Hey, guys, thanks for the question. And congrats on the strong end to the year. I guess your business is nice and stable. You signed four SPL in 2021. One in here in ‘22. I think at the time of the IPO, you talked about a goal of signing three or four SPLs per year. Are you still confident you can sign three or four this year? And I guess what I'm really trying to get at is just your comfort level in your funnel near term.

Well, the funnels has never been stronger, continues to strengthen. I think that's evidenced by the strong quarterly, quarter-over-quarter growth in cell therapy. Again, that builds pipeline for the SPLs. We don't control the SPLs, obviously, that's something that we have to deal with the partnership. But we see no reason why the dynamics are changing in a negative way for us, I don't think we've provided any further guidance on what ‘22 will bring, although I think our track record has been pretty consistent, and I think we’ve able to sign in three, four or five years, over the last several years. And that's something that we continue to work toward.

Okay, great. And, yes, go ahead Amanda.

I was just going to add just one quick comment there, obviously. And these are negotiations and contracts are long term, of course. So it's sort of hard again, you're putting that you've been putting in December -- to December timeframe is difficult, right. But to Doug's point, we have an ever increasing pipeline, which I think has been driven by a lot of things, and especially just the clinical support that we continue to build with the master file and that type of thing. So just to reiterate, that point and we can go through the numbers offline in terms of historical signings. But again, we still have the same comment around the pipeline being really strong and building, so.

Okay, yes, that's encouraging, I guess as analysts, we see that there's been a little bit of a shift in capital market dynamics in the last several months. Some of your customers admittedly are startups. So I would just be curious to ask about access to cash, access to capital, and whether or not you're seeing any softer demand from some of your customers, as it relates to maybe some customers trying to preserve capital.

Well, I think what they're working on with us is probably central to what their business model is all about, right? I mean, right. So if they're working on a product that's in going toward a pivotal, they're probably not going to be backing away from that from an investment perspective. So we're, we obviously track the cash that our partners have, but we're not seeing any softening of demand based on their cash requirement, their cash need or their cash index. We do pay attention, of course.

And another thing, just to kind of wrap up both of your questions, we're also not seeing any change in the economics as relates to the partnerships. So as you said, they've been fairly consistent and in terms of the pre-commercial sales attainment structure, so just too kind of tie both your questions together, we're not seeing any change there either.

Okay, that's great. And then, if I can ask one last one, you've talked about the VLx really being additive into new indications like monoclonal antibodies and viral vector production. So I think you've addressed this before. But is it safe to say that you're not expecting customers to return ATx, STx, and GTx in exchange for the VLx. So any comments about that, and I know it is early days now, but curious if you could just speak to that over the next year or two.

I don't see this as cannibalizing any of those products. In fact, I think it's just going to be the opposite. When you talk to these customers in bioprocessing, the VLx is actually a scaling down their process to some extent, they are working thousands, two thousands bioreactors, and they’re scaling down. And as they scale down, they'll want to have even more flexibility at the lower end to do their design and experiment. So I, my optimistic view like pragmatic optimistic view is we're going to not see cannibalization, we're actually going to see more opportunities, because now these companies will be able to convince the process development folks on the larger scale side that they can move from the STx to the VLx. And that will, I think, open up, frankly, new opportunities for one of the STx and the STx and GTx in these companies because they'll be more products that they can develop, knowing now that they can scale up even further with the VLx, if that that makes sense.

Thank you all and just thank you again for all your participation in today’s call. And your interest in MaxCyte, great questions and I look forward to talking to you all individually. Thank you very much.

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