Thank you for standing by, and welcome to MaxCyte's fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's call may be recorded. Should you require any further assistance, please press star zero. 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 for 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 our SEC filings.
The company undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise. 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 continued to deliver on all of our financial and strategic objectives in 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 2020 results, as outlined in the press release published earlier today, driven by robust performance in 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, total revenue was $33.9 million, representing growth of 30% compared to 2020. Our core instruments and disposables in 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 recognized $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 into later stages, including pivotal trials, suggesting we may see our first commercial product as early as 2023.
We are extremely proud to be able to support our partners in their efforts to bring advanced therapeutics to patients. We have continued to see our partners invest in ex vivo cell therapies and expand the scope of their research, including new cell types, modalities, and indications, which, if successful, would be positive for MaxCyte over 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 Bioscience signed in early 2022. We now have 16 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 12-24 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 the 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 customer's 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 large-scale Bioprocessing applications.
In 2022, we plan to work with several beta customers on the ExPERT VLx to build out 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 triples our manufacturing space and expands our process development capabilities. We also continue to further insource key elements of our 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 joined 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 and 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 to 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 to cell therapy customers in our core business grew a robust 43% over the same quarter last year, while sales to drug discovery customers also grew a strong 32%. We saw broad growth across the business with strength in instrument 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 had mentioned earlier. We did not recognize any SPL program-related revenue in the fourth quarter of 2021, although we recognized $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 will 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 dynamics, 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 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 into 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%-25% over the prior year.
As Doug mentioned, we remain optimistic about the prospects for our business and believe our SPL partners are well capitalized in 2022 and into 2023. In addition, the business momentum we saw in 2021 has 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 to our 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 customer's clinical and regulatory process and FDA decision making, which obviously we have limited visibility into. That said, we do appreciate the need to provide some forward 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 SPL partners. We expect the timing of milestone revenue to continue 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 opportunity for MaxCyte over the next couple of years, we've added an additional slide to our corporate deck that we wanted to call your attention to, which can be found on our website at 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 I, 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 I. These numbers are based on our current SPL partnerships, so 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 on those opportunities. We expect those investments to increase throughout the year in 2022 as we see the full year impact of headcount added in 2021 and continue to invest in those areas in 2022. 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'd like to open this up for Q&A.
Our first question comes from Jacob Johnson of Stephens. Your line is open.
Good evening or afternoon. Maybe, Amanda, following up on the comment you just made about the progression of SPLs, 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 consumables, somebody moving into pivotal kind of needs and what that looks like, potentially as they move into commercialization, just kind of what that, the scale-up, and kind of the core business looks like from those customers?
Yeah, I'll take a first stab at that and then, you know, 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 pre-clinical perspective, we tend to see a lot of usage with our lower scale processing assemblies just, you know, because obviously they're working on optimizing and things like that. 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 I trials are smaller, again, depending on the indication, it can be variable there.
you know, ramp over time as the customers move through the regulatory you know process into pivotal and beyond. 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.
Yeah, I think, you know, there's an algorithm here we're trying to build, and it's still, you know, low numbers, Jacob. You know, certainly auto versus allo, and if it's auto, it's gonna, or both of them, it's gonna be how many manufacturing sites they have and that would also be driven by how many locations they're running clinical trials. You know, some of our customer partners use ballroom type manufacturing processes where others use, you know, manufacturing trains. We're seeing also as customers get more comfortable with our technology and they put products into the clinic, they add more pre-clinical and non-clinical programs into their own. So we end up with additional product sales for that purpose. I don't think there's any real clear algorithm we've been able to build. I think we're still building it.
Obviously they do increase over the course of the relationship with the partner.
No, thanks for that. It's helpful context. Then on the kind of beta testing with VLx, you know, I think there's a wide range of use cases for that instrument from mAbs to viral vectors and maybe the most interesting, the allogeneic side of things. Can you just talk about, you know, in those kind of areas where you're seeing the most initial interest, you know, understanding that it's pretty early innings for VLx?
Yeah, I think it is still pretty early. I think that the one that we're focused on initially would be the mAb production, because I think that there's an immediate need in the marketplace for that a broad. I think it's a broad TAM expansion opportunity for the company. We do quite a bit of that in smaller scale with our STx today. It's a natural progression for our company, for our partners to want to scale the STx up to larger volumes. I think there's still work that has to be done on the VLx application to the viral vectors are still biology.
I mean, one of the reasons we brought, when Cenk joined us was to help with, you know, 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, you know, commercialize that in the proper way, the way that MaxCyte likes to do that. As 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. That's one of the reasons that we're investing in process development as a company and moving into a new facility so that we can better mirror what our beta testers are using the technology for.
Got it. Thanks for taking the question. I'll leave it there.
Thank you.
Thank you. Our next question comes from Julie Simmonds of Panmure. Your line is open.
Thank you very much. Great for the results, guys. Stephanie, 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 yet. Is this going to be another licensing model or is it going to be an outright sale and consumable type of model?
Hi, Julie. You know, part of the beta testing is to really spend the time testing that model. I think it will vary based on the application and vary based on you know, 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 in that upside with them as we do that. I think that same mindset will be valuable for the company and our partners, frankly, as they see the long-term opportunities for this technology.
Excellent. Thank you. Just on the expenses side, clearly you sort of are 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 the moving to the new site and the continued recruitment going to mean that we're going to see continual step up going into 2022 through 2022?
Yeah. I'll take a first crack at that. I mean, I think as you mentioned, you know, we see quite a bit of opportunity from an investment perspective in terms of, you know, driving further growth in cell therapy. 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 the full year impact of that in 2022. In addition, you know, we're continuously hiring as well. So, you know, we're not giving specific guidance, so to speak, but that's how I would think about it in terms of investment.
Lovely. Thank you very much. That'll be for the moment. Thank you.
Thank you. Our next question comes from Paul Cuddon of Numis. Your line is open. Paul, please make sure your line is unmuted and if you're in a speakerphone, lift your handset.
Oh, hi there. Sorry, is that working now?
Yes, sir.
Yes.
Okay, very good. Yeah, 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. With over 500 instruments in the installed base now, are you finding customers are sort of managing and happy with the machines they've got? Or are you having to put a little bit more support sort of 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 you know, very little work that has to be done to have them operational. 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 you know, 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. In terms of applications, we've seen the importance of your technology for cell therapy. We've spoken about sort of viral vectors and potentially sort of biomanufacturing in the past. I think this year has seen sort of quite, well, the last two years, sort of virology has become quite lucrative. There's pseudovirus kind of assays sort of happening within drug discovery. I'm just wondering whether there are sort of other kind of avenues where you're finding sort of early interest 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. I mean, one is that we're, you know, there's a lot of work that's being done on identifying new pathways and cells, right, for engineering and new cell types. We did the Intima deal, which is a TIL cell, and we're knocking down the cGAS-STING pathway, which is apparently an important one. There's a lot of basic research I think that's being done or translational research that's being done in the cell therapy space. We're seeing a lot of interest in that.
In the drug discovery side, on the, not Bioprocessing, but small molecule drug discovery, there's still quite a bit of, you know, 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. That's an area that we keep, you know, an active part on. It's just across the board. What we wanna be careful of, and as I think we talked about before, is we don't want to get pulled into the, you know, the academic research part of this, of the life sciences business. We really wanna focus our attention on more business-based, commercial-directed and clinical-directed and eventually commercial-only directed therapeutic development.
Okay, excellent. Just finally on the, I think I've got slide twelve of the corporate presentation, the example SPL NPV, you've got 6 programs per agreement launching 1 year, 2 failing preclinical, 4 into clinical, 1 reached commercial. Okay. 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?
Paul, let me take it first stab. That actually was also in the S-1. What we were trying to really do there is not give a specific or rather give an example SPL. Of course, each individual, you know, partnership is different, and there's different number of programs. We were trying to give 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. Then just thinking through, assuming one gets to commercial and then, you know, the others drop out, you can obviously apply whatever clinical risk, you know, you feel comfortable with.
We were just trying to provide an example of what each partnership could be worth in terms of pre-commercial milestones, which are actually pretty consistent across the partnerships.
Yeah.
given they're more related to regulatory timing
Mm-hmm.
Events versus the commercial side, which I think is what you can see from there, 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 just for that perspective. It was just really to give an example of the value potential from a revenue perspective.
Yeah, very useful. Thank you.
Thank you. Our next question comes from Dan Arias of Stifel. Your line is open.
Hi, guys. Thank you for the questions. Doug or Amanda, I want to just ask about drug discovery revenues. If I look back over the last couple of years, you've been in a pretty tight $7-$7.5 million range for a while, but you did step up this year to closer to $8 or to over $8. I remember you talking about the VLx system as having a pretty good opportunity in drug discovery. In fact, I think you just mentioned it on this call.
As we think about that, I mean, is it likely that with the 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-$9 million range going forward? Maybe not this year as much, but 2023.
I'll leave Amanda to talk about the specific numbers. You know, as we've been talking for the last couple of years, I mean, we recognize that there's a couple issues going on. One is that the drug discovery market is a huge opportunity for us. We've been able to show, I think, more value to our customers on the cell therapy side, so I think that there's been more attention being paid to the cell therapy group. We've also had the opportunity, since we had more capital, to really start to expand out our commercial team. Part of that expansion is providing us the ability to go a bit deeper into these drug discovery and Bioprocessing Partners.
I think that's what you're seeing as a result of that concerted effort to really, you know, rebuild that business from where it was several years ago. Not sure where we're gonna land from a numbers perspective, but, you know, the folks we're bringing in have most recently, you know, come out of that world as well. We're trying to really balance the cell therapy opportunity with the Bioprocessing opportunity and the drug discovery opportunity. Hopefully, that helps.
Yeah. Just a couple things. I mean, 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 PAs that sort of help lower the transaction, you know, the per transaction cost. I think that's been a driver. From a VLX perspective, we're, as you mentioned, seeing very strong interest from a beta customer perspective. Again, you know, this is a new market for us in terms of not necessarily new applications, as we do this with some of them with pharma customers now, certainly need to build out the use cases and the supporting data for those over time.
I think what we've been saying and continue to say is that we're, you know, very excited about the market opportunity there, as Doug talked about. Again, this is kind of a longer term, you know, two to three year type revenue driver.
Yeah.
for the company.
Okay. I mean, I don't mean to be overly picky on the numbers per se 'cause it's $1 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 know, to Doug's point on just the opportunity set in front of it, such that in a couple of years, maybe you do find that that's a 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.
Yeah. I mean, again, we're not giving specific guidance by market, but I think we you know we definitely you know are encouraged by what we have seen to date in terms of the adoption of some of these new PAs, as we mentioned. You know, there is you know some sort of obviously with the growth from the growth side of it there's a comparison dynamic. I think you know obviously the run rate now that we have is not with the VLX in the large scale market. That's sort of our current business.
You know, the team continues to look at new PAs that can help, you know, continue to meet customer needs, and I think we saw success there on both sides of the equation this year and this quarter. Especially this quarter. I'll just kinda leave it at that.
Yeah. Okay.
The only thing I would add to that, Dan, is that you know I think we mentioned that we did see some you know some compression on the drug discovery side because of the pandemic and the inability to really get into some of these bigger companies because they weren't operating at full capacity. I think you're seeing now you know the big pharma companies, the big biotech companies really coming back in a big way. I think that's gonna be helpful for that segment.
Yep. That is definitely good to hear. Okay. 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?
Yeah, I think, look, outside of the royalty, the milestones dynamics, we're seeing, you know, it's pretty consistent. There may be 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 sort of out of our control, right? It's our customers' regulatory timelines and FDA decision-making, which is pretty hard for us to pin down. Outside of that, I think, you know, we expect gross margin to be fairly consistent. I don't know, Doug, if you have anything to add there. Just, you know, all else equal with our current business anyways.
No. I mean, the band is pretty tight as you look at it. It's one or two points, right? I think Amanda hit it. I think we're comfortable with kind of that level of gross margins in the business. As I also mentioned, you know, I think, you know, the milestones are gonna help push that gross margin number up a little bit. As we become more basic in manufacturing, certainly in the earlier days when we're manufacturing more SKUs, you're gonna see some erosion, a little bit of erosion in gross margin, but I think they're gonna offset each other.
Okay. Very good. Thank you, guys.
Thank you. Our next question comes from Matt Larew of William Blair. Please go ahead.
Hi, good afternoon. In terms of the future market opportunity, I think at the time of the NASDAQ IPO, you characterized an SPL pipeline around 50 and I think growing to somewhere like 130 or 140 over the next 5 years. Just curious if there's been any change to those thoughts. I guess part two would be just thoughts around your ability to participate in those opportunities. 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.
I'll take the first part in terms of the market and how we calculated that and then turn it over to Doug. That slide's in the deck. And essentially it was sort of a point in time analysis where we looked at the pipeline and we said, all right, obviously we don't. From an SPL perspective, we partner with companies. We looked at the pipeline that was in our current market where we're seeing a lot of success, so IO and inherited disorders. We said, all right, how many of those should be SPL opportunities? That's where we came up with the 50. We have seen incremental interest outside of those markets, or sorry, indications, so autoimmune as an example.
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. That was really our take at the time. I think as you know, we're continuously seeing increased complexity, right, in the market in terms of cell type and engineering, or how much engineering of the cells companies are doing. That would all sort of point to increased adoption of other non-viral delivery technologies. I think the other thing I would say there is that, we're also seeing interest, you know, outside of kind of the U.S. and Europe as well. That wasn't factored into that analysis.
We haven't updated that honestly since the IPO, but we're just trying to give a perspective. I would say if anything, the market's sort of larger at this point. Doug, do you want to take the other part?
Let me comment on that, then the second part of the question, Matt. First off, you know, with 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? 'Cause anyone who's, you know, acquiring the technology or licensing technology, they're licensing it for all the attributes that we have and the benefits we provide to our customers. That's using the baseball analogy, because hopefully we'll start seeing some baseball again, that's the on-deck circle for us.
We wanna really make sure we've got a lot of people in the pipeline, a lot of companies in the on-deck circle, so when they come up for the SPL deals, we've got them captured. 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.
You know, 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 you know, preloaded library of validated cell-specific products. Have to mention that that's becoming a bigger and bigger issue with CMC issues around FDA. The scalability is still key, you know, we stand alone in that aspect. With the VLx, we've actually just extended the range by basically 10 times the STx and the GTx. Then the quality. You know, it's the cGMP, it's the single-use disposables, it's the Master File.
In all four of those things, we excel in each of those four, and there's no one out there that can touch us in any of those four. We, you know, we're not gonna be complacent, continue to push the envelope, but we're not seeing, you know, an impact on the business.
Okay, that's great. You know, another year for strong instrument placements. Would you be curious if you can give us any sort of color around instrument placement location in terms of cell therapy versus drug discovery, or how many of those placements were driven by current customers scaling up their efforts versus new customers adopting the technology?
Yeah. I don't think we can give any guidance on that. I do, though, think 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. You know, we're seeing the fruits of our labor in setting up beachheads in Asian countries and throughout Europe and the U.S. is starting to pay dividends. It takes time.
We're a small company, but I think you're starting to see kind of that flywheel effect as we build out our sales and marketing team, we build out our field application scientists. We're able to solve, uniquely solve you know, customer problems in you know, locations that we couldn't really touch before we had the capability and capacity and capital to do so. Now we can do that. I think we're gonna see an increase across the board in the performance of the business.
Okay, thanks. Just 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? How much at that point would still need to be insourced in terms of components versus largely assembled internally?
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 were to happen with the site, right? I don't see us putting all of our eggs in one basket. You know, we're not gonna be basic in you know, injection molding, for instance. We think that that's better left for companies that are out there doing that on a daily basis. 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 wanna ensure, there's obviously some commonality among these different disposables, and we wanna control them, and we'll be able to control better, you know, the mix of finished goods based on the ability to leverage certain individual components. I think it's gonna help us to build inventories, become more flexible. As our customers move toward commercialization, I think it's gonna be even more important that we've got excess capacity in our manufacturing capabilities to support them. Because, as you know, in the therapeutics business, there can be rather significant variations in terms of demand for these products, and we wanna make sure that we're able to support that.
Great. Thanks, Doug.
Thanks, Matt.
Thank you. Our next question comes from Max Masucci of Cowen and Company. Your question please.
Hi. Thanks for taking the question. Congrats on the continued momentum in the business. First one, you know, FDA released some new draft CAR T product development guidance last week. You know, it covers a range of topics, you know, the ideal time to implement manufacturing changes, you know, call to action for better monitoring of critical quality attributes. You know, it's a comprehensive draft guidance, but from a bird's eye view, you know, Doug, it'd be great to hear your perspective, if you've had a chance, you know, to review it just in the context of your SPL business and, you know, your non-SPL core business.
Well, sure. Well, you know, a lot of that guidance is focused on CMC and manufacturing control, right? 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 a BLA, for instance. I think that bodes favorably for MaxCyte. I think there's also 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. I think we've been, you know, working for the last couple decades to make sure that we can do that.
This is a welcome validation of what we've been really focusing our attention on over the last at least decade to ensure that we can provide our partners with, you know, what they need to move all the way, you know, into the clinic and all the way through the clinic with our, you know, Master File. I think we've mentioned that we now have over 40 clinical trials associated with it. We feel like we're in the right, you know, we're doing the right stuff.
We think also that guidance provides us with additional opportunities to build the business, because what we've learned, I think, we've learned with our partners that consistency and product characterization are important. I think our company is really set up to, you know, look at new potential technologies and new potential solutions to these problems as partners move closer to commercialization. We're working with, as you've recognized, with some of the leaders in the commercialization of cell therapy. I think we've got a kind of an inside view of what's gonna be important. Our sense is that guidance was a good validation.
You know, there's a really important interface between industry and FDA, whether that be through BIO and/or through ARM or ISCT. You know, MaxCyte is actively involved in all those organizations to ensure that we can help to, you know, provide the standardization for the industry. 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. Maybe just a little follow-up there. It seems like FDA is, you know, nudging CAR T developers to, you know, at least attempt to lock down manufacturing methods a bit earlier in development. Just curious if that would be, you know, that nudge or that urge from the FDA, you know, would be, you know, could spur a tailwind for some GMP grade, you know, closed platforms or GMP grade PAs in the core razor blade business. The PA portfolio is, you know, it's continuing to expand and round out. You do have, I know I believe the three processing assemblies are being sold to both research and GMP customers.
It would be great to hear if you're seeing that, you know, shift to cGMP products occurring, you know, earlier in the process and if that could be a tailwind.
Yeah, I think, you know, our view with our customers have been get involved with us early because 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. I think that does play well. I think we've been at the forefront, but I think we recognize the need and the opportunity, and I think we've seized it. I think we're in pretty good shape.
Great. Thanks for taking the questions. Appreciate it.
Thanks, Max.
Thank you. Once again, to ask a question, please press star one on your touchtone telephone. Again, that's star one on your touchtone telephone to ask a question.
Our next question comes from the line of Mark Massaro of BTIG. Please go ahead.
Hey, guys. Thanks for the question and congrats on the strong end to the year. I guess, you know, your business is nice and stable. You know, you signed four SPLs in 2021, one here in 2022. 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? I guess what I'm really trying to get at is just your comfort level, in, you know, your funnel of near term.
Well, the funnel's never been stronger. It continues to strengthen. I think that's evidenced by, you know, the strong 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 do with a 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 2022 will bring. Although I think our track record's been pretty consistent and I think we've been able to sign three, four or five a year over the last several years, and that's something that we continue to work toward.
Okay, great.
Yeah-
Yeah, go ahead, Amanda.
I was just gonna add just one quick comment there. Obviously, these are negotiations and contracts are long term, of course. It's sort of hard, you know, again, you're putting, not you, but you're putting a December to a December timeframe is difficult, right? To Doug's point, we have an ever-increasing pipeline, which I think has been driven by a lot of things you know, especially just the the clinical support that we continue to build with the Master File and that type of thing. Just to reiterate that point, we can go through the numbers, you know, offline in terms of historical signings. Again, we still have the same comment around the pipeline being, you know, really strong and building, so.
Okay. Yeah, that's encouraging. I guess, you know, as analysts, we see that there's been a little bit of a shift in capital market dynamics in the last several months. You know, some of your customers admittedly are startups. Would just be curious to ask about, you know, 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, you know, maybe some customers trying to preserve capital.
Well, I think, you know, what they're working on with us is probably central to what their business model is all about, right? I mean, right? If they're working on a product that's going toward a pivotal, they're probably not gonna be backing away from that from an investment perspective. We, you know, obviously track the cash that our partners have, but we're not seeing any softening in demand based on their cash needs or their cash end dates. We do pay attention to that, of course.
Yeah.
Okay.
The other thing, just to kind of wrap up both of your questions, we're also not seeing any change in the economics as it relates to the partnerships. As you said, they've been fairly consistent and, you know, in terms of the pre-commercial, sales-based payment structure. Just to kind of tie both of your questions together, we're not seeing any change there either.
Yeah.
Okay, that's great. 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. You know, I think you've addressed this before, but is it safe to say that you're not expecting customers to return ATx, STx, GTx in exchange for the VLx? Any comments about that? I know it's early days now, but I'm 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 gonna do the opposite. When you talk to these customers in Bioprocessing, the VLx is actually a scaling down of their process to some extent. They're working in 1,000- and 2,000-liter bioreactors. They're scaling down, and as they scale down, they'll wanna have even more flexibility at the lower end to do their design and experiments. We're at least my optimistic view, my pragmatic optimistic view is we're gonna not see cannibalization. We're actually gonna 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.
That will, I think, open up, frankly, new opportunities for the STX and the GTX in these companies because there'll be more products that they can develop knowing now that they can scale up even further with the VLX, if that makes sense.
Yep, that makes perfect sense. All right. Thanks, guys.
Thank you all. I just thank you again for all of 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. This concludes today's conference call. Thank you for participating. You may now disconnect.