Good day and thanks for standing by..
Good day and thank you for standing by. Welcome tot he MaxCyte First Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode.
After the speakers presentation, there will be a question-and-answer-session [Operator Instructions] I will now like to hand the conference over to speaker today, Sean Menarguez, Director of Investor Relations. Please, Go ahead..
Good afternoon, everyone. My name is Sean Menarguez and I'm the Director of Investor Relations here at MaxCyte. Thank you all for participating in today's conference call. On the call from MaxCyte, we have Doug Doerfler, President and Chief Executive Officer Officer, and Ron Holtz, Interim Chief Financial Officer.
Earlier today, MaxCyte released financial results for the first quarter ended March 31st, 2022. 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..
Thank you, Sean. And good afternoon, everyone. And thank you for joining MaxCyte First Quarter earning call. I'll begin with the discussion of our business and operational headline during the quarter and follow that, a detailed financial review from [Indiscernible]. We will then open the call for questions. We are very pleased with the start to 2022.
As our team continue to deliver on all financial and strategic objectives in our plan. MaxCyte ExPERT platform continues to be the premier cell-engineering technology enabling the development of our growing set of advanced cell-base therapeutics.
With our additional resources at hand, we continue to invest in our people and capabilities as measured but healthy rate as we seek to ensure the success of our partners.
Ron will provide more details later in the call, but I know that we generated very strong first-quarter 2022 results as pre -announced last month and outlined in the press release published today. These results are anchored in robust performance in our core cell-engineering business, which was up 48% year-over-year.
We generated a significant SPL program related revenue on the quarter with revenue timing running a little sooner than our internal plant forecasted, yielding strong year-over-year growth in the quarter. As you know, we have very limited visibility into the timing of our partners clinical progress.
And as such, it's challenge for us to provide precise information regarding program related revenue beyond general expectations for the year. First quarter revenue was a record $11.6 million, up 78% over the first quarter of 2021 with a very strong growth in the core business.
Growth in revenue to cell therapy customers was 57% year-over-year and to drug discovery customers was 23% year-over-year. Cell therapy growth was primarily driven by both instrument and PA sales.
We are seeing expansion of our global customer base across all stages of development and encouraged by our traction with cell therapy customers at early development stage, which continues to strengthen our robust SPL pipeline. During the quarter, we recognized $2 million in clinical milestone revenues.
As we have previously indicated, our partnership agreements are strictly confidential and so we will not be answering any specific questions relating to our SPL partners, their clinical progress, or their respective development programs. However, we remain excited about the progress our partners have been making in the clinic.
We continue to sign new SPL partners and see additional SPL programs enter trials. Further, we have seen our existing clinical SPL portfolio progress into later stage, including pivotal clinical studies suggesting we may see a partner's first commercial product as early as 2023.
Overall, our core business revenue growth and recognition of the SPL program related revenues are signs of the strong execution by our growing commercial team and robust customer demand; this strength seen in new sales and leases of instruments, as well as strong PA sales.
The timing of customer PA purchases and leased instruments as it prepared for pivotal trials and commercialization can be hard to predict. And we would expect them to remain lumpy until our SPL portfolio and clinical progress of those partners is broad enough to smooth out that lumpiness from individual programs.
Given our strong performance, we wanted to highlight that we have not seen any weakness in the demand for our products and associated support from our customers. We have strong relationships with our partners and customers and believe MaxCyte’s expert platform is a core aspect of their therapeutic development strategy.
We continue to meet and exceed our customers’ expectations for supply and scientific support. And we continue to have a growing new business development pipeline. Our SPL pipeline remains strong and we continue to expect additional SPL partnership announcements this year at comparable economics to prior partnerships.
In the first quarter, we signed an agreement with Intima Bioscience, which we highlighted on our last call. We now have 16 SPL partners that are going to bring more than 95 development programs in the aggregate of which more than 15% have entered the clinic.
In the near term, we are optimistic about the potential for our SPL partners to generate meaningful and growing revenue from both their pre -clinical research and clinical progress, as well as, hopefully, commercialization of partner therapeutics over the next 12 months to 24 months and beyond.
We are making important investments to support our future revenue growth, including investing in our commercial teams, developing and expanding in-house manufacturing, and in our in-house bioprocessing in cell therapy applications and process development labs.
These investments will advance our ability to take advantage of expanding markets, the emergence of new therapeutic development programs and companies, and support our partners as they move toward and into commercial launch of therapeutic products.
This investment will come with continued growth and headcount across most areas of the organization, particularly in R&D and sales and marketing, including alliance management.
These kinds of investments have delivered strong growth today as we support our partners potential success, and we continue to be upbeat about the value of these investments we're making in 2022 and beyond. In closing, we have had an excellent first quarter for 2022 as we continue to execute on our financial and strategic goals.
We're getting excited about our opportunity going forward, particularly in the cell therapy market and are making the right investments to drive growth across the business. I will now turn the call over to Ron to discuss our financial results.
Ron?.
Thanks, Doug. Hello, everyone. As Doug mentioned, we realized record revenue of $11.6 million in the first quarter compared to $6.5 million in the prior year's quarter based on strong performance in both our core business and through the clinical progress milestones delivered by our SPL partners.
Core business revenue was $9.6 million in the first quarter of 2022, compared to $6.5 million in the first quarter of’21. This includes revenue from cell therapy customers of $7.4 million growing 57% year-over-year, while revenue from drug discovery customers was $2.2 million, growing 23% year-over-year.
We saw a broad growth across the business with particular strength and instrument sales in cell therapy and in processing assembly sales in both cell therapy and drug discovery during the quarter. We recognize $2 million of SPL program related revenue in the first quarter of 2022 compared to immaterial program related revenue in Q1 of 2021.
Moving down the P&L, gross margin was 91% in the quarter versus 89% in the first quarter of the year prior. The increase in gross margin was driven by the higher SPL program related revenues. Excluding that SPL revenue, gross margin was relatively unchanged.
Total operating expenses for the first quarter of 2022 were $14.7 million compared to $12.2 million in the first quarter of 2021. And recall that Q1, 2021 included $3.9 million of expense from winding down investments in our CARMA platform.
As Doug mentioned, our current strategy is to continue to make meaningful investments across the business to take advantage of the opportunities we see to accelerate organic growth over the coming years.
The overall increase in operating expenses was primarily driven by increased headcount to support growth in field sales and field science, manufacturing, and lab teams.
Growth in [Indiscernible] company related and stock-based compensation expense also contributed to the higher level of expenses compared to the same period a year ago as our NASDAQ listing did not occur until the third quarter of 2021.
We have a very healthy balance sheet with total cash and cash equivalents and short-term investments at $246 million as of the end of the first quarter, and no debt. Note that in Q1 we began to see the first portion of cash investments in construction of our new facility.
Total investments this year in our new headquarters is expected to be approximately $12 million in 2022. We are increasing our outlook for 2022.
We now expect revenue from our core business, which include sales and leases of instruments and sales of disposables to cell therapy and drug discovery customers to grow at least 25% compared to 2021 core business revenue. We saw strong business momentum in the first quarter and remain cautiously optimistic about the balance of 2022.
Turning to our SPL program economics, as we've discussed in previous calls, the timing of SPL revenues is predicated on our customers’ clinical and regulatory progress, where we have limited visibility.
Taking into account the earlier than expected Q1 program related revenue, we continue to expect 2022 SPL milestone revenue of approximately $4 million.
Doug?.
Well, thank you, Ron. 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 for patients that may not otherwise have treatment options.
As always, we want to take this opportunity to thank our team, Board, suppliers, investors, and the amazing industry that we have the honor of serving. We are very pleased to report strong first quarter results and MaxCyte remains well positioned for growth, and we are excited about the opportunities ahead.
We are now opening up the line for questions..
Thank you. [Operator Instructions] Please stand-by while we compile the Q&A roster. And our first question comes from Max Masucci from Cowen. Your line is now open..
Hi. This is Stephanie Yan for Max Masucci. Thanks for taking the questions, and congrats on a great quarter.
If you look broadly at some of the more recent therapies your SPL partners have launched in the clinic and compare them to the therapies you supported during the 2017 to 2020 time frame, what's the diversity of cell types and molecules are you seeing? Are there any emerging trends to call out?.
Good question Stephanie, and thanks for the question. We are seeing quite a bit of movements since 2017. Our first one of our first deals with CRISPR, we're seeing that continuing, we're seeing multiple edits being done to cells.
We're seeing companies move from T cells and some T cell subsets, and K cells, a lot of focus now on different sorts of gamma delta T cells and B cells. So the cell populations -- the subsets are increasing. Think again, we're seeing more complex edits which I just mentioned.
We're seeing different tools being used, some of them have been around for quite some time, like zinc finger nucleases, transpose on transposase. And so we're seeing a lot of difference. We're also seeing [Indiscernible] some new indication areas, principally with inherited disease with CRISPR in their stems - in their sickle-cell program.
Obviously, in autologous stem cell also and allogeneic T-cell treatments. And we're also seeing [Indiscernible] cancer. We're also seeing movements into auto-immune disease and some of our earlier stage customers are working in neurodegenerative disease and infectious disease.
We really think this whole field is just beginning to explode as people become much more comfortable with these engineering tools and manufacturing methods..
Got it. That's super helpful.
And also with the recent pullback in publicly traded bio manufacturing peers and likely some degree of a pullback in private asset value, has your approach towards M&A changed at all? Are you leaning more towards [Indiscernible] complimentary M&A or are you entertaining some later, more transformational deals?.
Yes, I think we're seeing some movement in the private financing now. It's reflective, I'm thinking -- a few months behind the decrease in financings in the public market. I think -- just to put an exclamation point -- we're not seeing any reduction of demand for our products with our partners. So that's good.
We've always thought about expanding our corporate development group.
Our targets are confidential, but I think it's fair to say that we had talked about staying very close to our knitting; staying close to the cell-engineering space, not moving too far upstream and downstream, and really looking for opportunities where we can solve really big pain points that customers are having in the cell therapy field.
How we do that, I think we're open to all the different opportunities, but I think if we do a deal -- if we do several deals, they're going to be, again, around solving these engineering problems for our customers..
Got it. That's great. Super helpful. And if I could squeeze in one more. During the last call, you highlighted that you were working with several beta customers on the ExPERT VLx to build application data.
Can you provide some more detail on the progression of the beta launch or share any additional milestones on the VLx product roadmap?.
Well, sure. We released that product in the fourth quarter of this year, and much of the focus at that point was really investing in the business and refining our strategic plan. We did the release in 2022. We think it's a very interesting marketplace and we think this is a highly disruptive technology in large scale bioprocessing.
So we're working with these customers with the ExPERT VLx to build applications data to support that movement. We think the the opportunities is large, it's going to take time too. And if you follow that opportunity with our partners, I think on of the areas that we're very excited about is the rapid production of monoclonal antibodies.
We think there's immediate need for that in the marketplace. It's -- I think it's a broad term expansion opportunity for the company.
And we're doing quite a bit of this in small scale with the STx today, so it's a bit of a natural progression for us to move as our companies, our partners were to move from the mid-scale, which is the STx, up to larger volumes. And again, work has to be done in this area and applications.
It's -- there's significant amount of work that's done pre and post electroporation engineering and process development. That's one of the areas that we focused investments, is to ensure that we have the ability to support our customers all the way through their process..
Got it. Thanks so much for that color. Really appreciate it..
You bet. Thank you..
Thank you. And our next question comes from Matthew Larew from William Blair. Your line is now open..
Hey, good afternoon. [Indiscernible] loud and clear that no change in terms of demand from customers but -- just because it's been such a topic this earning season.
Often you have 6 to 7 programs per customer and it certainly would make sense that with lead assets, there would be no change, but curious if you're seeing any reprioritization or de -prioritization of up pipelines from customers at all beyond the [Indiscernible] secondary assets..
Matt, we're really not seeing it that this point. I think that our focus is typically on the lead asset or number two on the company, like you suggested. And as far as we can see, these companies aren't pulling back on those. A lot of the work -- if they're pulling back, they may be pulling back on some preclinical programs.
But again, that's pretty -- it's usually pretty confidential with our partners that we would have much vision in that -- the ability to see what's going on. The other issue is that our business has grown quite a bit. We have very strong core business growth in the first quarter.
So I think that's evidence that things continue to be moving forward at a pretty good rate..
Okay. And then just in terms of hiring, just curious, what you're seeing out there and if you've been able to hire at pace with what you're expecting. I think [Indiscernible] might -- it came in a little bit light of what we were thinking.
I'm just curious if that's any sort of efficiencies that you've felt in or if you've began schedule at all on the hiring front..
Well, I'll talk -- I'll let Ron talk about the expense side of it, but we have a very active hiring group. We've expanded our human resources in team building. We're also being -- I think we're being very creative in terms of how people work in the company. Over the last couple of years, as many of you know, it's been primarily virtual.
We're still seeing that as a primary way of bringing in great people. And of course, that has its own series of leadership and management challenges. But if you, I think, you find the right people, you bring them in and you provide them the tools that they need to work virtually, I think we're going to do pretty well.
Ron, would you like to talk at all about the expense changes for the first one?.
Yeah. I -- we're being successful hiring the people that we want. I think it's a more competitive environment that we've seen in prior years. That means we might be a little bit behind what our plan was for ramping headcount. I don't think it's a material effect, but that competitive environment makes it take a little bit more time to find people.
We are being successful hiring the people we want when we find a candidate more often than we've seen in the past, they have other offers in hand, but we're winning the people that we want. So I think that's gone well..
Okay. Thanks, Ron.
Last one just be just about two months ago where there was a competitive launch in the space, we just be curious of last couple of months if you've been out and perhaps heard feedback on that device or had it compared to your technology? Is there anything you would highlight about what you're hearing or what you see as key differentiators, which have been maintained even relative to this newer launch?.
So I'll say a couple of things, Matt, but I'm obviously not going to give -- I'm not going to give the [Indiscernible] book to the competition. This is a product that they've been talking about, it’s our [Indiscernible] product for quite some time. They're showing it up -- it's showing up in the major meetings.
We're not seeing it playing any role in the commercial bake-offs with customers so we're not seeing the impact of that. I think the thing that I think differentiates us is performance, and flexibility, and scale, and cGMP, and our focus on supporting our customers in the cell-engineering space.
So, we welcome the competition and I think it just brings more validation that this is a pretty interesting an area that's going to have a lot of future benefit for our company..
That makes sense. Thanks..
Thanks, Matt..
Thank you. And our next question comes from Dan Arias from Stifel. Your line is now open..
Opening guys, thanks for the questions. Doug, you mentioned some lumpiness that can arise with respect to the individual programs that you have in your prepared marks. I'm just curious whether as some of your partners have pushed into the later stages, you've gotten comfortable with the purchasing around key milestone events.
In other words, how consistent are you finding their spending to be into a scale up to a new trial stage and then maybe out as well.
Should we think about there being step-ups ahead of a milestone and stepped down afterwards, or is that something to be mindful of or is it more or less consistent?.
I think the lumpiness is only around the milestones themselves, because we know we have a number of those, but we know we have 15 in the clinic, I think at some point bringing the larger number of ANDA actually smoothed that out. I'm not a mathematician, so I don't know how you really get to that number.
I think it's still new to us, and so we're seeing ramp-ups, obviously, preclinical into the clinic. We're actually seeing quite a bit of non-clinical work that's being going on with some of these products as well.
I mean, once they don't -- these companies don't call preclinical, they call non-clinical because they're doing experimentation alongside their product that's been in clinical development. So I think because of the relatively small number of programs, we're -- we don't really have a good handle on what demand looks like.
I think that's one of the reasons why we've elected to start doing more in-house manufacturers. We have the flexibility to support these customers. And obviously, we will more that once we start moving into a commercial launch of the -- of one of these -- of some of these products in the next couple of years.
Hopefully, that answered your questions and a couple of things with that..
Yeah, it -- and you're right and I think some of it just, it seems like it's naturally TBD on what happens from here. Maybe just on a different topic, new business development and new account wins.
If I go back a year ago to when we were talking about the business at the time of the listing, you guys had mentioned share within the clinical non-viral delivery markets that was like 40% or so. And then there was another 15% that was in discussion, as you put it, which kind of felt like it had good conversion potential.
Are you able to update us on that chunk and how you've converted the business that look like it was coming your way, call it 6 months to 12 months ago?.
I can't update it quantitatively, but I can say qualitatively that we're meeting all of our goals and we're winning that business and converting companies to -- even in the early stage to our technology.
We're also -- we've invested a bit in working in these translational medical centers, where you have a cGMP manufacturing suite within an academic setting. And we've begun to have a much more focused marketing effort and sales effort because at the end of the day, that's where many of these companies are spawned from.
They're coming out of an academics lab and once they get into the clinic or the [Indiscernible] into the clinic, someone's forming a company around them. And so if we can get that -- our technology embedded in that early enough, we think that's going to just feed that SPL pipeline for the future..
Okay. Maybe if I could just sneak one more in here since it feels like we have the time here.
On the strategic plan that you were touching on, you had alluded to it, I think, in your comments with the VLx, but I think part of what you were trying to do this year or into this year was move upstream and downstream of where you are today in cell therapy or at least evaluating how you can do that.
Is that something we should keep an eye out for? And if so, would that be an organic effort or more on the inorganic side?.
Yeah. We're building another corporate development group. We've been spending a lot of time on strategy and where we want to play. And I think we can win around -- again around, like I said in the first call, around that [Indiscernible] solid generic steps.
Some of these are going to be organic where we've already identified some opportunities that we can build into what we do. We do believe that there's a real need in the marketplace for product consistency, product characterization, ways of being able to control product potency, which has become more and more of an issue.
And we think there's some analytical techniques that we may be looking to become more basic in. These opportunities will most likely be in the manufacturing area, not in the early [Indiscernible]. So I think we've got a -- if you think about our company, we're on the quadrant were up in there, we're high-value proprietary manufacturing enablement.
We want to stay up in that sector and really focus our team on that. And so there's a -- we think there's quite a bit of opportunity there. Technologies are maybe being used in other ancillary industries like in bioprocessing and [Indiscernible] over.
And there's also a number of technologies and products that are being developed by smaller companies that have to make that decision whether or not they want to make those investments in sales and marketing.
And in today's environment, where capital isn't quite as -- capital markets aren't quite as robust as they were six or nine or 12 months ago, I think there's going to be -- boards of smaller companies are going to be thinking hard about if they want to make that investment, take that risk.
Because execution is -- it can be very difficult that marketplace and I think we've been able to achieve a certain level successfully..
Okay. Helpful, Doug. Thank you..
Thanks. Thanks, Dan..
Thank you. And our next question comes from Jacob Johnson from Stephens. Your line is now open..
Hi. This is Mac on for Jacob. Just a couple of quick ones from me.
On the drug development side, can you talk about how much of the investments in R&D and sales and marketing are focused on this side of the business? And how much do you think this could accelerate growth in the segments?.
Yes. Some of the -- I think we're starting to see the benefits consumer investments. We've made over the last couple of years on new processing assemblies. So we've got a -- we continue to have a rather robust voice of customer and [Indiscernible] voice customer is focused on drug discovery.
We've been talking about that [Indiscernible] that market's been, I think flat, slightly growing and we wanted to really try to accelerate that a bit. And I think we reasonably successful in the first year, the first quarter of picking that up. We'll continue to do that.
And I think the more we can -- the more we can focus the use cases and drug discovery, which includes bioprocessing, I think the better off we're going to be able to build that business. The VLx is that launch -- the initial launch when it happens, we'll be probably over in the bioprocessing side, not in cell therapy.
Because in our minds, drug discovery would include the mid and large scale production of monoclonal antibody. So I think you're going to see hopefully quite a bit of growth in that sector as we continue to make investments in the drug discovery side..
Thanks. Also, last quarter you commented on that you're seeing interest outside the U.S.
How large of an opportunity are the European and Asian Pacific markets for you?.
We've been in Europe for quite some time and there just continues to be strong growth throughout the EU and UK. So we're pretty basic in sales and marketing operations there. So I think we've -- we're making the very prudent investments that will be there. We're seeing growth in cell therapy certainly in China.
We're carrying out the best way of approaching that. That's a tough market to, I think, be successful in. I don't think it's a particularly tough market to get into, but I think it's a tough market to maintain some level of sustainability and that's what we're really focusing our attention on. We've had some success.
I think we've had a lot of success in Japan and, in some extent, Korea. So I think you continue to see us focusing our interest in Asia. And of course in Europe. I mean, Europe is one of the backbones now of cell therapy..
All right, thanks, Doug..
Sure. Thank you..
Thank you. [Operator Instructions]. And our next question comes from Mark Massaro from BTIG. Your line is now open..
Hey, guys. This is Vivian Wohl for Mark. Thanks for taking the question. So for your very existing SPL portfolio, can you share any detail on the rough split of your customers that are in the clinic at present or in later stage development. Thanks..
Yeah. So the only -- what we do share and we said that there is 16 partners out the end of last year, 2021. And other 16 partners, 95 programs are associated with those partners and 15% are in the clinic. And then I know there's been quite a bit of, I think speculation and views by some analysts in terms of what products we're supporting.
We have publicly disclosed that we're deploying the CTX001, which is obviously the joint for sickle cell disease. I think we've been a bit less for us in some of the other programs, because all these deals, as we mentioned, are confidential. So we really don't feel comfortable talking about those in any setting..
Okay got you. And can you just touch on SPL panel. I think you've previously discussed a need to sign three to four SPLs per year and just any update there.
And how are the conversations about this progressing?.
Yes. The pipeline continues to be very robust as there has been merger. We just signed into the first quarter of this year. We continue to guide to, I think three or four [Indiscernible], I can remember that specifically. And we're building out our business development group, Alliance Management group.
So we think that there's a tremendous amount of opportunity to that. One of them has to do more with the progression of our partners and it does actually in our negotiations, besides being move from preclinical in the IND-enabling studies.
That's the turning point where they roll -- want to have access to our patents, our technology, our master founders, sort of things..
Thank you. Great. Thanks for answering the question..
Sure..
Thank you. And I'm showing no further questions at this time. I'd like to turn the conference back over to Doug Doerfler for closing remarks..
Great. Well, thank you all for the questions and your interest and your support of MaxCyte. It's been indeed an amazing 2021 and a great start to 2022, and despite the -- obviously, the investor sentiment in the industry.
And we're quite hopeful and I think we're very confident that we're going to see some really amazing clinical data coming out of our partners over the next several quarters and then I think that's going to portend well for the cell therapy industry in general and MaxCyte in particular.
So again, thank you all for your support and look forward to any subsequent discussions we will have. But we will be meeting with investors in the next several days, and if you have any particular questions, you can certainly contact us at ir@maxcyte.com. Thank you, Sean. Thank you, Ron.
And thank you all for -- and Gigi, thank you as the Operator for this call. Be safe. Thank you..
Take care, everyone..
Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect..