Earnings Call Transcript - MXCT Q2 2022

Sean Menarguez, Director of Investor Relations

Thank you, Norma and 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; and Ron Holtz, Interim Chief Financial Officer. Earlier today, MaxCyte released financial results for the second quarter ended June 30, 2022. A copy of the press release is available on the company's website. Before we begin, I need to read the following statements. 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.

Doug Doerfler, CEO

Well, thank you, Sean and good afternoon, everyone and thank you for joining MaxCyte's second quarter earnings call. I will begin with a discussion of our business and operational highlights during the quarter, followed by a detailed financial review from Ron, along with an update on our revenue outlook for the year. We will then open the call for questions. I am very pleased with our start to 2022, as our team continues to deliver on the financial and strategic objectives in our plan. MaxCyte's ExPERT platform and team continues to be the premier cell engineering technology and partner, enabling the development of a growing set of advanced cell-based therapeutics. With additional resources at hand, we continue to invest in our people and capabilities at a measured but healthy rate as we seek to take advantage of the growing markets and support our customers' and partners' growth. Ron will provide more details later in the call but I’d note that we generated very strong second quarter 2022 results, as outlined in the press release this morning. We continue to build traction and saw steady growth in our core business, which was up 45% year-over-year led by revenue from cell therapy customers, which increased 61% year-over-year, while revenue from drug discovery customers increased 4%. Cell therapy revenue growth was driven by significant increases in both instrument and PA sales. We are seeing expansion of our global customer base across all stages of development and are encouraged by our traction with the cell therapy customers in early development stages, which continues to strengthen our robust pre-SPL partnership pipeline. Our partnership pipeline is the strongest it’s ever been and spans across a wide array of cell types, approaches and indications. We did not recognize any SPL program-related revenue during the second quarter and we remain excited about the progress our partners have been making as they progress their clinical programs, including into pivotal studies. We are also hopeful regarding the potential for some of our partners’ therapeutics to reach commercialization over the next 12 to 24 months with others reaching that space thereafter, which we believe will generate meaningful and growing revenue to us. In addition, we continue to sign new strategic platform partners. I do want to note that due to the confidentiality of our partnership agreement, we will not be able to answer any specific questions related to SPL Partners, their clinical progress, or their respective development programs. A few weeks ago, we signed an SPA with LG Chem, Korea’s largest chemical company and a globally diversified petrochemical advanced materials and biotechnology company. We are excited to partner and support their CAR-T programs for solid tumors. This represents our first SPL with a South Korean company and broadens our reach in Asia. With this most recent agreement, we now have 17 SPL partnerships, covering more than 95 development programs in the aggregate, that’s based on the calculations we talked about in January 2022, of which more than 15% have entered the clinic. We remain optimistic regarding the potential to add additional SPL partnerships this year and the comparable economics to prior partnerships. We maintain strong relationships with our partners and customers and believe the combination of MaxCyte’s ExPERT platform and the support of our team is a core aspect of their therapeutic development strategy. Our partners are well funded and leaders in the cell therapy industry, developing a wide-ranging set of innovative gene editing approaches. Our platform continues to lead the industry in transfection efficiency, cell viability and scalability, which are critical capabilities through the development of cell-based therapeutics. And combined with our unparalleled scientific support is the core of what brings customers to our platform. A key element of our work this year is the ongoing investment we are making to support our future revenue growth. These investments include expanding our commercial teams, expanding in-house manufacturing, enhancing our applications and process development capabilities and ongoing product development, as well as reinforcing our business infrastructure. All these investments are central to supporting our customers and partner success in driving continued revenue growth. This summer, we are completing our move to new headquarters in a facility nearby in Maryland. A key part of our headquarters project is the expansion of our instrument and disposables manufacturing capacity from research and clinical scale to now commercial therapeutic scale. Building out in-house manufacturing is expected to increase our manufacturing capacity, build redundant disposable manufacturing capability and enhance our control over the supply chain. These developments are critical to supporting our SPL partners as their programs advance. In addition, we continue to see exciting growth in our end markets, particularly in novel cell types and gene editing applications. Our ongoing investments in our applications and process development labs will keep us at the forefront of these changes, where we play a central role enabling innovation in cell therapy as the field advances. Additionally, the PD lab is building out the platform and processes needed to support the use of the VLx platform in large-scale bioprocessing, including the production of monoclonal antibodies. We also are investing in our sales, marketing and field science applications team to further our ability to capitalize on growing markets. Finally, we are making the necessary investments in our business infrastructure, information systems, quality systems, regulatory, legal, finance and accounting to support the growth of the company. These investments will advance our ability to support expanding markets, engage successfully with emerging therapeutic development programs in companies and support our partners as they move towards the commercial launch of therapeutic products. We remain confident in the value of these investments to our partners and that they will continue to deliver strong growth. As we make these investments, important to note that we remain well funded with modest cash burn and a strong balance sheet as we move toward profitability. In summary, we had an excellent second quarter, 2022. We remain excited about our opportunity going forward, especially in the cell therapy market as we continue to execute on our financial and strategic goals and make the right investments to drive growth across our business. I will now turn the call over to Ron to discuss our financial results.

Ron Holtz, Interim CFO

Thank you, Doug. Hello, everyone. As Doug mentioned, we reported total revenue of $9.6 million in the second quarter, compared to $7.1 million in the prior year's quarter, driven by strong performance in our core business. Core business revenue was $9.6 million in the second quarter of 2022, compared to $6.6 million in 2021. This includes revenue from cell therapy customers of $7.7 million, which grew 61% year-over-year, while revenue from drug discovery customers was $1.9 million, up 4% year-over-year. The increases were primarily driven by strong instrument and disposable sales growth in cell therapy. We did not recognize any material SPL program-related revenue in the second quarter of 2022, as compared to $0.5 million of program-related revenue in the second quarter of 2021. Moving down the P&L. Gross margin was 88% in the quarter versus 89% in the second quarter of the year prior. Total operating expenses for the second quarter of 2022 were $17.2 million, compared to $10.7 million in the second quarter of 2021. The overall increase in operating expenses was primarily driven by increased staff and field sales science, manufacturing, lab teams that support customers' and partners' growth. The increase also included growth in public company-related stock-based compensation and marketing expenses compared with the same period a year ago. Furthermore, we have a very healthy balance sheet with combined total cash, cash equivalents, and short-term investments of $240.9 million as of the end of the second quarter and no debt. As communicated last quarter, total investments this year in our new headquarters is expected to be approximately $12 million in 2022. Based on the growth year-to-date and a robust pipeline, we are raising our revenue outlook for 2022. We remain cautiously optimistic about the balance of 2022 and now expect revenue from our core business, which includes sales and leases of instruments and sales of disposables to both cell therapy and drug discovery customers to grow approximately 30% compared to 2021 core business revenue. Turning to our SPL Program economics. As we've discussed previously, the timing of SPL revenues is predicated on our customers' clinical and regulatory progress and, therefore, is fundamentally more difficult to predict than core revenues, which we manage directly. Based on that more limited visibility, we continue to expect 2022 SPL milestone revenue of approximately $4 million. Lastly, we believe that our modest cash burn and debt-free balance sheet will support our future plans for profitable growth. We expect to end this year with approximately $220 million in cash, cash equivalents, and short-term investments. Now I'll turn it back over to Doug.

Doug Doerfler, CEO

Well, thank you, Ron. So in summary, we remain optimistic 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 who may not otherwise have treatment options. We are very pleased to report strong second quarter results and raise our full year revenue outlook. We're excited about the opportunities ahead. And as always, we want to take this opportunity to thank our team, the Board, suppliers, investors, partners, and the amazing industry that we have the honor of serving. Thank you and I'm open for any questions.

Max Masucci, Analyst

First one related to the core cell therapy business, another strong beat in the segment. It would be great to understand how much of that strong growth in the core cell therapy business, both on the instrument placements and processing assembly side of things, how much of that growth is being driven by SPL partners versus customers that you haven't signed SPL agreements with?

Doug Doerfler, CEO

Ron, do you want to take that one? Thanks, Max.

Ron Holtz, Interim CFO

The SPL customers in the cell therapy sector are generally larger, contributing more significantly to our growth compared to smaller or new customers, who typically purchase or lease just one instrument. While I don't have the exact proportion at the moment, it's clear that a larger share of our growth is coming from SPL customers.

Max Masucci, Analyst

Okay, great. And then for the second question, could you help us understand how licensing fees have changed as a part of our revenue and growth, perhaps in relation to when we went public on NASDAQ or in recent quarters?

Ron Holtz, Interim CFO

Yes, I don't believe there has been much change in the proportion. The mix primarily consists of recurring revenue, which includes licensed instruments that continue to grow. As long as the instruments are maintained, this provides a solid foundation for growth. Processes and assemblies also tend to be consistent and represent a stable portion of revenues. From what I observed today, there hasn't been a significant shift in the past few years.

Max Masucci, Analyst

Okay. Got it. Maybe final one. Several MaxCyte engineered therapies in various phases of clinical development, all with aspirations of regulatory approval and launch. I think for us, at biomanufacturing conferences, there seems to be an emphasis on companies preparing for commercialization, logistics and scale up a bit earlier than, say, a few years ago. So just a broad question. Is that what you’re seeing on your end? And if so, is there anything that you need to do at MaxCyte to sort of prepare yourself operationally for that next wave that will be coming over the next, call it, three to four years?

Doug Doerfler, CEO

Let me address that. It’s a relevant question and exactly what we've been focusing on over the past year. We mentioned relocating to our new facility, which aims to significantly enhance our manufacturing operations and streamline the production of processing assemblies. Our goal is to build extensive capabilities. Additionally, you may notice an increase in inventory, which reflects our efforts to make our supply chain more robust in order to support our customers as they transition from late-stage clinical development to the launch phase. There is considerable speculation about what these numbers might be, but we want to ensure we are ready to meet the needs of our commercial customers at any level. We're dedicating considerable thought to this. We are also investing in regulatory field support since these companies typically prepare for global launches, especially in the EU, U.K., and U.S., and we are enhancing our quality group to ensure that all processes are in place to meet customer audit requirements. There is a lot of activity underway, and it's safe to say that at MaxCyte, our top priority is preparing for our partners' launches.

Max Masucci, Analyst

Great. And congrats on the other great quarter.

Doug Doerfler, CEO

Thanks.

Julie Simmonds, Analyst

Excellent quarter guys, well done. Just looking at the split between cell therapy and the drug discovery side of things, cell therapy obviously going amazingly well. Drug discovery is slightly lower in terms of the growth. Is there anything particular behind that? Is just that due to sort of an internal refocusing or where the sales team are focused because I know they do both now? Or is there something else going on underlying in the market we should be thinking about?

Doug Doerfler, CEO

Hi, Julie. Thank you for staying up late in London. I understand it's late there. The drug discovery market for us generates less revenue compared to the cell therapy market. Therefore, you will naturally see some fluctuations in growth rates from one quarter to another. However, we did achieve double-digit growth.

Ron Holtz, Interim CFO

Did we lose Doug?

Operator, Operator

Ladies and gentlemen, please stand by. Again, ladies and gentlemen, we’re experiencing technical difficulties. Please stand by. Thank you Doug to resume.

Doug Doerfler, CEO

Sorry, I'm not sure where I cut off here, but my Internet completely went down. I'm sorry, Julie. So the drug discovery business is smaller than cell therapy in terms of revenue. Consequently, you may notice some fluctuations in growth rates from quarter-to-quarter. However, if you look at the first half of 2022, the growth rate was around 13% or possibly 15%, which is somewhat higher than we had previously seen. Currently, our growth rate is in the mid-single digits. You can see an improvement with the release of the VLx in the drug discovery area, and we are quite excited about that upcoming launch.

Julie Simmonds, Analyst

He just disappeared again. And when was the VLx launch, the full launch expected because that was going to be my next question.

Ron Holtz, Interim CFO

Julie, formal launch of the VLx will be sometime this year. So it's placed into the market at the beginning of this year and we're going to put it out formally at the appropriate conference and that's something that's in our planning. We just haven't announced the date.

Doug Doerfler, CEO

I'm sorry, I'm just trying to move between two different computers. I'm sorry about this.

Julie Simmonds, Analyst

And I suppose just one final question. Just as far as cost is concerned. Clearly, they’re continuing to ramp, which is what we’d expect given what we’re doing at the moment. Are you expecting by the fourth quarter of this year, you’ll sort of reach a more sort of, I suppose, stable and gently growing run rate than the step-up we’re seeing at the minutes? I mean, do you think by that point, you will be at the sort of closer to the level of sort of ongoing costs at that point?

Ron Holtz, Interim CFO

Julie, I missed a piece of that. Were you asking about the operating growth step up in the second quarter?

Julie Simmonds, Analyst

Yes.

Ron Holtz, Interim CFO

Yes, that makes sense. It's common for us to experience a significant increase in operating expenses from the first to the second quarter as hiring starts early in the year. This process takes some time to ramp up, and as we bring new people on board, it fuels the bulk of our expense growth for that quarter. In the latter half of the year, we generally see a moderation in those expense growth rates. Therefore, we don't expect the same level of increase from the first to the second quarter in the upcoming periods. While we won't be completely flat, the growth will be considerably less steep than what we observed in the first half of the year. This year has been a significant investment period for us, as Doug mentioned earlier. We anticipate that in future years, the year-over-year growth in expenses will stabilize after the substantial increase we've seen this time around, driven by important investments in areas like in-house manufacturing, our new facility, and broadening our team.

Dan Arias, Analyst

Doug or Ron, maybe to Ron’s point on the growth skew towards the SPL programs. When we were talking last year, you noted that the average number of platforms per strategic partner was, I believe, three or four. So assuming that there are one or two in the mix and that would also mean that there maybe are some like five or six. So the question is, one, is that sort of the installed base range within the SPL subset? And then I’m just curious if there is a pull-through difference per instrument within that subset that kind of speaks to sort of the consumables runway per unit that you might expect as these partners progress? Or does the pull-through per unit basically stay the same, they just have more unit…

Doug Doerfler, CEO

Let me address that. Ron, feel free to add your thoughts. Thanks for your inquiry. We are currently working with our partners to understand this better. At this moment, it's challenging to have a clear expectation of how many placements these customers will require. This largely depends on their target indications, manufacturing plans, launch strategies in various countries, and regulatory approaches. Each situation is unique. We are not sure if we are witnessing a surge in placements or if we are in a stable state, so we are monitoring it closely. That said, we are ready for a surge if it occurs. Additionally, we are observing that some partners are conducting a significant amount of nonclinical work alongside their clinical activities, which has actually resulted in an increase in research efforts for their CMC and controls rather than a decrease in pull-through as they enter late-stage clinical trials. I hope this information is helpful.

Dan Arias, Analyst

Yes, it is. But Doug, can I clarify whether that total pull-through refers to the accumulation of more instruments or pull-through per instrument? As we consider these customers moving forward, their utilization of one instrument might be higher, potentially generating more revenue.

Doug Doerfler, CEO

Dan, I understand the question. I don't think we have enough data yet to suggest yes.

Ron Holtz, Interim CFO

I would like to add that the number of instruments per SPL partner is influenced by the number of programs running through the clinic. The revenues, as Doug mentioned, are difficult to summarize, but there is typically a balance between the revenue generated from instruments and that from processing assemblies; both tend to grow together. The number of instruments can vary considerably for different programs, but it's the number of programs that really impacts how many instruments a customer might have. A customer involved in a single program will have fewer instruments, whereas a customer participating in multiple programs can significantly increase their instrument count as they progress through clinical stages.

Dan Arias, Analyst

Yes, definitely makes sense. And maybe relatedly, just as a follow-up, Doug, obviously, a lot going on in biopharma and cell therapy specifically. One of the assumptions that has underpinned your long-term model is that you would average three new SPLs per year. Is that an assumption that you’re more or less still comfortable with when you look out, say, at the next like three to five years?

Doug Doerfler, CEO

Yes, we are very comfortable. I mean, I think we've done two already this year. So we're very comfortable with that expectation. And we're building an organization around that.

Unidentified Analyst, Analyst

This is Max on for Matt. I just wanted to start off with a high-level question around funding. Obviously, there’s been a lot of attention paid to the slowdown we’ve seen year-to-date in biotech funding. Just wanted to get your thoughts and see if you’ve seen any sort of impact from the slowdown in biotech funding observed year-to-date. Doug, I think maybe in the past, you mentioned a little bit of pipeline rationalization, expected at some point in the future. But I’m just wondering how things have trended so far since the end of the quarter and whether or not you’re seeing a slowdown in activity so far here in the back half of the year?

Doug Doerfler, CEO

Yes, we are definitely focused on this issue and are in communication with our partners and other funding sources to ensure a long-term perspective. However, we have not observed a decline in our cell therapy business, as shown by our gross figures for the second quarter and the first half of the year. It has been noted previously that one company might tighten its spending, particularly on early-stage research rather than later phases, which we do not see affecting us. We are also noticing the emergence of new capital and companies launching with more complex cellular therapies, which is promising for MaxCyte as that aligns with our capabilities in handling these advanced therapies.

Unidentified Analyst, Analyst

Got it. That's very helpful. For my second question, I wanted to follow up on Julie's inquiry regarding the outlook for the different segments. You're projecting a 30% growth for the base business this year. I was wondering if you could provide more details on how to assess growth in the latter half of the year for each segment. I apologize if I missed this earlier due to the connection issues. Additionally, looking ahead to 2023, you mentioned a long-term growth expectation of 25% for the base business. I'm curious if you believe that's a reasonable target for next year and how you envision the growth rates for each segment beyond 2022.

Doug Doerfler, CEO

Ron, do you want to take that first and I’ll jump in?

Ron Holtz, Interim CFO

Yes. As Doug mentioned, looking back a bit from a single quarter, drug discovery appears to be experiencing solid growth. It's been increasing at double-digit rates in the first half of this year, which is an improvement compared to the impact of COVID, which significantly affected drug discovery. We believe that maintaining a consistent growth rate in double digits is reasonable. Additionally, we don't anticipate significant changes in the cell therapy trajectory. While there may be some fluctuations in specific quarters, it aligns with the growth patterns we've observed over the last 18 months.

Unidentified Analyst, Analyst

On VLx, you mentioned that rapid production monoclonal antibodies represent a significant opportunity for growth. However, how feasible is this considering it would necessitate the FDA to waive its requirement for MaxCyte to be produced from the master cell line? Are there other near-term applications you are exploring that could generate VLx revenue either later this year or in 2022?

Doug Doerfler, CEO

Yes. The significant opportunity in monoclonal production will arise once the FDA approves the use of transit materials. This is a major potential, but there is also a considerable opportunity before that, involving larger quantities of monoclonal antibodies for later-stage preclinical work. Much of this work currently utilizes stable cell line produced materials, which can take months to years to create. We expect to see some initial uptake. I can't provide many details about the use case once we launch the product, which we plan to do in the second half of this year. Other applications to follow include the production of allogeneic cell lines, which I believe will be a significant opportunity, but that will take longer to realize. In the near term, we are focused on the production of viral vectors in suspension cells instead of using the current process, which involves adherent cells. Thus, our next major step will be to provide application information to the market to facilitate the production of those products.

Unidentified Analyst, Analyst

And our next question comes from Jacob Johnson with Stephens. It's Hanna on for Jacob. A couple of questions. You just signed your first SPL in APAC with LG and it seems like you've had traction in this area. Are there any updated thoughts on traction internationally, especially as it relates to APAC?

Doug Doerfler, CEO

Yes. So that announcement was just right after we closed the second quarter. LG Chem is a pretty large biotech group. They go a little over $0.5 billion invested in biotech now. We've had a standing group of relationships in Korea as we do in Japan and in China. The challenge for us is really around the licensing model and does that work in those environments. We've been cautious about entering in a big way in the China market for a lot of different reasons. But we are beginning to make more investments to secure licensed deals in that market. So it's part of our strategy for the next couple of years. Again, there's a huge opportunity, we think, in that marketplace but I think we have to be really thoughtful about how we enter it, how we protect our franchise and how to ensure we work with the right partners that can provide us kind of the long-term value that we're seeing with our existing 17 partners.

Unidentified Analyst, Analyst

And one follow-up. As we think about the cell and gene therapy pipeline. At a high level, it seems like interest in gene editing and allogeneic therapies continues to grow. As you think about your customer conversations now versus a year or two ago, are you seeing more opportunities at the macro level?

Doug Doerfler, CEO

Yes, absolutely. We began discussing this when we went public about a year ago, regarding the significant growth in allogeneic cell therapies. That has indeed materialized. Companies are increasingly shifting away from autologous therapies when possible, as we believe the potential in allogeneic therapies is greater. In allogeneic development, nonviral methods become crucial, as well as multiple edits, which aligns perfectly with MaxCyte's expertise. One of our main focuses since going public has been the rising interest in allogeneic cell therapies, and we are extremely well positioned in this area, which is attracting more attention from companies and investors. We are quite enthusiastic about the new programs emerging in this field.

Operator, Operator

And at this time, I'm currently showing no further questions. I would now like to hand the conference back over to Mr. Doerfler for any closing remarks.

Doug Doerfler, CEO

Well, thank you very much and thank you all for your participation today and your engagement and certainly these questions. And we look forward to speaking to many of you in the near term. And again, thank you for your support and look forward to again updating the market in the third quarter but we will also be taking individual meetings in the next couple of weeks with investors and analysts. So thank you very much. Appreciate it.

Operator, Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.

Doug Doerfler, CEO

Thank you.