Earnings Call Transcript - MXCT Q3 2024

Operator, Operator

Hello and welcome to MaxCyte Third 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 were provided. I would now like to hand the conference over to Scott Feinberg of Investor Relations. You may begin.

Scott Feinberg, Head of Investor Relations

Good afternoon, everyone. My name is Scott Feinberg, and I am responsible for Investor Relations here at MaxCyte. Thank you for participating in today's conference call. Joining me on the call from MaxCyte we have Maher Masoud, President and Chief Executive Officer; and Doug Swirsky, Chief Financial Officer. Earlier today MaxCyte released financial results for the third quarter ended September 30, 2024. 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. Except as required by applicable law the company has no obligation to publicly update any forward-looking statement whether because of new information, future events or otherwise. And with that I will turn over the call to Maher.

Maher Masoud, President & Chief Executive Officer (CEO)

Thank you Scott. Good afternoon everyone. And thank you for joining MaxCyte's third quarter 2024 earnings call. MaxCyte reported $8.2 million of total revenue in the third quarter primarily comprised of core revenue, which exceeded our internal expectations. We were pleased with execution of our team and continued demand for our ExPERT Platform which has been further demonstrated by the six new Strategic Platform Licenses that we signed this year including one signed in the third quarter. A new record number of SPLs signed in a single year for the company. We have increased our expectations for core revenue growth in 2024 due to our confidence in underlying business trends we've seen over the last three quarters. The core business for MaxCyte in the third quarter performed very well, particularly in cell therapy. Our instrument install base grew to 739 as of September 30. Instrument revenue was $1.8 million as our sales team executed well against our pipeline opportunities in the third quarter. Though our instrument revenue continues to be impacted by continued customer caution on capital equipment spending, we were pleased with our stable instrument results and a return to year-over-year growth in the quarter. PA revenue was very strong at $3.4 million in the quarter, growing 54% year-over-year and up sequentially driven by broad-based customer demand. Our PA revenue is dependent upon our customers' research activity, progress of clinical programs and commercial activities. The strength in PA growth sequentially and year-over-year was encouraging to see. The funding environment remains largely unchanged from last quarter at a stable state. Though we have continued to see some green shoots, customers overall in cell and gene therapy are operating with a somewhat cautious mindset particularly when it comes to capital equipment spending. However, through the third quarter we are very encouraged by stability and growth in our core business, which underscores our consistent execution throughout the year. Overall, cell and gene therapy market trends continue to bode well for MaxCyte's platform. We continue to see growth in activity in non-viral cell therapies and cell therapy developers moving towards more complex therapies that require multiple engineering steps. Furthermore, our scientific expertise in this space allows us to support customers utilizing electroporation with other transfection modalities such as with viral transduction as evidenced by some of our SPL partners, such as Be Biopharma and Kamau Therapeutics. We remain extremely optimistic about the future of cell and gene therapy and MaxCyte's long-term opportunities. Turning to our SPLs, we remain encouraged by our customers' continued progression through the clinic during the quarter and optimistic about their future impact for patients. Our SPL pipeline continues to be robust and we've executed well on the opportunities in our pipeline this year resulting in six new SPLs signed in 2024 thus far including the most recently signed Kamau Therapeutics in September. We have reached a new record number of SPLs signed in a year which we believe is a true testament to the differentiation of our electroporation platform, the execution of our global teams and the sizable opportunity in cell and gene therapy that continues to strengthen. Our most recently signed SPL Kamau Therapeutics is a clinical-stage stem cell therapy gene correction company utilizing targeted gene integration to develop cell therapies that can potentially cure a variety of life-threatening diseases including sickle cell disease. We are excited that MaxCyte's Flow Electroporation technology has the potential to enable them to optimize their clinical manufacturing process and progress their lead asset through the clinic. The addition of Kamau Therapeutics brings our total number of signed SPLs to 29. We continue to pride ourselves on our ability to maintain long-lasting relationships with our customers and provide them with the regulatory, scientific and technical support required for them to succeed. In the quarter, we received a small amount of SPL Program-related revenue from commercial royalty revenue related to CASGEVY following completion of patient dosing. We are excited about the strong commercial opportunity of Vertex's FDA-approved CASGEVY as we are seeing that Vertex is just beginning to recognize revenue. During their Q3 earnings call on Monday, Vertex reported that the first patient was officially dosed in Q3 and around 40 patients completed cell collection, up from approximately 20 as noted on their Q2 call. Vertex indicated that CASGEVY has been enthusiastically received by patients, physicians and policy makers and the launch is gathering momentum across all regions. However as we have previously mentioned we have limited visibility on the timing of the patient treatment journey. As such, we are continuing to exclude CASGEVY-related commercial milestone revenue from our 2024 revenue guidance. We plan to provide you with updates as they come from Vertex. We remain very optimistic of the potential of CASGEVY to benefit patients as the first and only approved CRISPR gene editing therapy just as we remain excited about the multiple therapies being developed by our other customers which could be approved as early as 2026 or 2027 all of which will provide us commercial milestone revenue if approved. For the remainder of 2024, we plan to continue to invest in areas of high growth which include sales and marketing, best-in-class customer support and product development. As part of the strengthening of our commercial infrastructure, we are pleased to have announced the promotion of Ali Soleymannezhad, former Executive Vice President of Bioprocessing, to Chief Commercial Officer at MaxCyte. Ali will lead our commercial operations to increase adoption of the ExPERT Platform, support our customers and expand the company's market in cell and gene therapy. We also continue to invest in complementary technologies for our customers and recently hired a Head of Engineering Jeremy Kolenbrander who has more than 25 years of cell and gene therapy product development experience to best understand our customers' workflow needs and improvements. MaxCyte remains very disciplined with spend. We carefully evaluate our portfolio of opportunities for investment and remain focused on allocating resources to high-value projects that we believe will deliver long-term growth. This year we established disciplined processes across the organization. This was done for a few reasons: to allow us to have the capabilities to launch and commercialize products our customers need and to help us expand our customer base all while maintaining our healthy cash balance sheet. With our healthy cash position compared to initial guidance, our updated revenue growth guidance and the impact our new Chief Commercial Officer and Head of Engineering are having on the organization I am very confident the best practices we have implemented will continue our growth into next year. Similar to the operational and management changes we implemented recently we announced the appointment of Cynthia Collins to MaxCyte's Board of Directors. I would like to take a moment to extend a warm welcome to Cynthia as we look forward to her support in our efforts to drive future growth. Cynthia has over 40 years of experience in the biotechnology industry including her recent role as CEO of Editas Medicine and prior role as CEO of Human Longevity. Her expertise and leadership in cell and gene therapy are unparalleled and I'm excited to work with her to help cell therapy developers bring a new class of therapies to market over the coming years. In summary, we are pleased with our third quarter results and the strong progress that we have made so far this year. MaxCyte is well-positioned to deliver on our increased 2024 financial projections and we are excited to continue to provide the best quality support to our customers. The differentiated support that MaxCyte brings to our customers is truly unparalleled from regulatory know-how to scientific and technical support on programs. We believe that we are and will continue to remain the cell engineering platform of choice in the industry. Before I close and turn the call over to Doug I want to take a little time to explain MaxCyte's future growth, what we have implemented this year and my vision of our company's future. I joined MaxCyte over seven years ago. We were still trying to figure out how to monetize our best-in-class, highly differentiated cell engineering platform for non-viral delivery. Over the last seven plus years we became one of the only companies in the cell and gene therapy space with an enabling technology which garners clinical and commercial recurring revenue and has signed 29 SPLs with significant future revenue potential. Since I took over as CEO to start the year we have bolstered our management team and our engineering and scientific expertise to underpin my vision to expand our sales funnel and increase the number of products we sell and license throughout therapeutic product development for research, clinical and commercial use. Our goal is to become the premier cell engineering company, providing therapeutic companies with multiple product offerings to drive development of the next generation of therapies. The cell and gene therapy space is in the early stages of growth, whereby the landscape of medicine and treatment of patients will rely on cell and gene therapies and I truly believe MaxCyte can leverage our top talent and the infrastructure we've built over the last few years to commercialize many more product offerings. With these changes, we've made significant progress towards our goals of launching new products in the foreseeable future, while we continue to sustain our healthy cash balance sheet. I remain as confident today as the first day at MaxCyte that we will continue to help drive the industry forward and be a leader with best-in-class product offerings. With that I will now turn the call over to Doug to discuss our financial results.

Doug Swirsky, Chief Financial Officer (CFO)

Thank you, Maher. Total revenue in the third quarter of 2024 was $8.2 million compared to $8 million in the third quarter of 2023, representing an increase of 2%. We reported core revenue of $8.1 million compared to $6.6 million in the comparable prior year quarter representing an increase of 23%. This includes revenue from cell therapy customers of $6.5 million, which increased 39% year-over-year and revenue from drug discovery customers of $1.6 million, which declined 14% year-over-year. Within core revenue, instrument revenue was $1.8 million compared to $1.7 million in the third quarter of 2023. Lease revenue was $2.5 million compared to $2.4 million in the third quarter of 2023. And processing assemblies or PA revenue was $3.4 million compared to $2.2 million in the comparable prior year quarter. As Maher mentioned, instrument revenue continues to be most impacted by the cautious capital spending environment for our customers. At the same time lease revenue has remained stable, indicating strength in our revenue from clinical SPL partners. PA revenue demonstrated strong growth in both year-over-year and sequential performance which we were pleased to see. 53% of core revenue in the third quarter was contributed by SPL customers demonstrating our continued balance of early-stage to clinical-stage customers. SPL Program-related revenue in the third quarter of 2024 was immaterial compared to $1.4 million of SPL Program-related revenue in the third quarter of 2023. As Maher mentioned, the SPL revenue recorded in the quarter was primarily from Vertex patient completion of CASGEVY infusion. Moving down the P&L, gross margin was 76% in the third quarter of 2024 compared to 90% in the third quarter of 2023. The decline in gross margins is primarily due to a one-time inventory write-off related to our decision to discontinue a product redesign initiative for our PAs. This initiative began about two years ago with the bulk of the design and engineering work done last year. Ultimately, the PA redesign efforts were deemed inadequate due to lower efficiency and viability compared with our current PAs. We've taken the appropriate steps including changes to our leadership earlier this year to ensure that similar design and procurement does not happen again moving forward. We recently hired a new Head of Engineering to spearhead our new product design and development efforts, as Maher mentioned. Excluding inventory provisions and SPL Program-related revenue, non-GAAP adjusted gross margin was 85% in the third quarter compared to non-GAAP adjusted gross margin of 88% in the third quarter of 2023. Total operating expenses for the third quarter of 2024 were $20.3 million compared to $21.2 million in the third quarter of 2023. The decrease in operating expenses was driven by operational and process changes made this year which Maher referenced. Going forward the company continues to be disciplined making moderate and targeted investments in high-growth areas that offer long-term returns. We finished the third quarter with combined total cash and cash equivalents and investments of $196.6 million and no debt. We are increasing our expectations for year-end cash equivalents and investments and now expect to end the year with $185 million. Continuing with our full-year 2024 revenue guidance, we are increasing our core revenue guidance and reiterating our SPL Program-related revenue outlook. We are increasing our core revenue expectations to be at least 5% growth compared to 2023. We also continue to expect SPL Program-related revenue of approximately $6 million in 2024, which represents no additional milestone payments this year. Our SPL Program-related revenue is difficult to predict and subject to the timing of partner development programs. As a reminder, our 2024 outlook also does not include royalty revenue from CASGEVY. To close, MaxCyte remains in a great position to execute on our 2024 outlook, with a continued focus on exercising disciplined spend to deliver long-term growth. Now I'll turn the call back over to Maher.

Maher Masoud, President & Chief Executive Officer (CEO)

Thank you, Doug. We are proud of our progress thus far in 2024 and look forward to supporting our customers as they progress through the clinic. I would like to thank our MaxCyte team for their dedicated work to our company and customers each and every day. With that, I will turn the call back over to the operator for the Q&A. Operator?

Operator, Operator

Thank you. Operator instructions were provided. Our first question comes from the line of Matt Larew with William Blair. Your line is open.

Matt Larew, Analyst, William Blair

Good afternoon. I wanted to focus on PAs in the quarter, obviously up about 50% year-over-year and up sequentially. You referenced that the funding environment while improving is not really impacting your numbers quite yet. What was your sort of assessment of what drove the strength beyond your expectations in the quarter? And how does both that outperformance as well as the continued funding environment shape the way you are thinking about the fourth quarter versus the third quarter and then sort of into next year?

Maher Masoud, President & Chief Executive Officer (CEO)

Thanks for the question, Matt. We have always talked about PAs as sort of leading instrument sales in terms of being able to see that there has been some recovery here. So we're very pleased to see PAs have been strong really all year. And so we do think that there are some signs out there that the market is improving. I think that really is a lot of it. Clearly, you will note there is a slight uptick on a year-over-year basis in how much of our core revenue was from SPL partners. So clearly, the maturity of some programs is helping drive PA sales to some extent. But in terms of driving our output for the year, we have raised guidance for 2024 to reflect the fact that we are doing better than we thought we would when we set guidance at the beginning of the year. We are not in a position to guide for 2025 obviously right now but we are a month into the fourth quarter and we feel really good about the position we are in versus the revised expectations we just set.

Matt Larew, Analyst, William Blair

Okay. And then just on the write-down you took related to inventory and product development—over the last couple of years, obviously you have made nice progress as your partners have advanced with the core business as well as SPL—but if we look at VLX development and then this development, I think two things that maybe you would have liked to see a different outcome. Just as you've been a company with a good cash position and ability to invest, as you think about where to go for organic investment from here and where the return is for you, what are the next paths you take to either improve the technology or broaden out some of the capabilities?

Maher Masoud, President & Chief Executive Officer (CEO)

Great question, Matt. And that's the reason why we hired Head of Engineering Jeremy Kolenbrander as I mentioned. Obviously, we're not giving guidance as to what those improvements are that we're bringing, but we've built capabilities within the organization that will allow us to understand high customer-impact needs and build workflows around those needs, and ensure that we're doing it in a very smart and efficient manner where we obviously are going to do what we believe has the highest impact for revenue for the company before we actually take on those initiatives. And as you mentioned, you talked about the one-time write-off and the VLX, the processes that we've built in this year, the addition to the management team as well and really removing inefficiencies across the organization help prevent us from having those types of one-time write-offs and really work on those customer workflows that we believe have the highest revenue potential for the company over the foreseeable future.

Matt Larew, Analyst, William Blair

Okay. And then just one quick accounting cleanup that in $24,000-ish of revenue related to CASGEVY. The level of granularity you're able to provide—just remind us how the revenue recognition works here because I guess I hadn't necessarily anticipated we'd see anything in the quarter.

Doug Swirsky, Chief Financial Officer (CFO)

Thanks, Matt. I guess I'll take that one. We didn't necessarily expect it this quarter either, but obviously they've dosed the patient. We did recognize some revenue associated with that. We have a process where we interface with our partners and customers for all folks that reach that commercial stage where we've got downstream economic participation. We'll have a process in place to recognize revenue when it's been earned. In this case, I do want to emphasize that that amount you see there is not just related to that one item. There's some legacy revenue in there related to amortization of a previous upfront associated with one of the clients. So it's not all straight CASGEVY royalty income, but I can represent the majority of it is related to that. They're just getting started. And again we've got a process to make sure that we're getting data from our customer that allows us to appropriately recognize revenue and that's just getting started.

Matt Larew, Analyst, William Blair

Okay. Thanks very much.

Maher Masoud, President & Chief Executive Officer (CEO)

Thank you.

Doug Swirsky, Chief Financial Officer (CFO)

Thanks, Matt.

Operator, Operator

Please standby for our next question. Our next question comes from the line of Julie Simmonds with Panmure Liberum. Your line is open.

Julie Simmonds, Analyst, Panmure Liberum

Thank you. Congratulations on beginning to see a turn in the process as far as cell therapy is concerned. It's nice to see. Quick question as far as the deferred income is concerned. Historically that always used to be a fairly good guide as to growth rates going forward. So I was just wondering what that currently includes and whether we can still see it as a sort of leading indicator.

Doug Swirsky, Chief Financial Officer (CFO)

So deferred income would be related to leases, and so we take in that income and it gets amortized over the life of the lease. In general, lease revenue has been relatively stable. And so in terms of the health of business that's just one indicator. I don't think there's that much to read into where we sit on this versus previous quarters; it has been very stable. I don't have much to add on that.

Julie Simmonds, Analyst, Panmure Liberum

Lovely. Thank you. And then just as far as the SPLs are concerned, clearly you've done six this year, which is really good and can be a nice step up on previously. In terms of the remainder of this year, I'm not going to ask whether you're going to do another one or not because that would be, if you do, you do. If you don't, you don't. Great. But should we be looking in future years to be on the 3% to 5% that you've historically guided to? Or do you see this as a one-off bumper year as it were?

Maher Masoud, President & Chief Executive Officer (CEO)

Great question Julie. Obviously when we think of the 3% to 5% range, we're comfortable with that. That's a sign of a very healthy company. It's a sign that we're still doing the best scientific support. We have the best platform and are highly differentiated. So that 3% to 5% is what we're comfortable with for the foreseeable future. Obviously we signed six this year, which is above that 5%, which is great. And a lot of that has to do with also the fact that we've built out these high-value relationships over the years with these companies that happened to be close to all going into the clinic around the same time or preparing to go into clinic around the same time. So that's why we signed six in a relatively short time period. But 3% to 5% is where I feel very comfortable; that shows that we're highly differentiated from the rest of the field. And that's why that 3% to 5% is a number we can stand by for the foreseeable future Julie.

Julie Simmonds, Analyst, Panmure Liberum

Excellent. Thank you. Just one quick accounting one. CapEx has been a little bit lower this year, is that just your ongoing slightly more moderate approach to spending and should we expect that to continue?

Doug Swirsky, Chief Financial Officer (CFO)

Well, I think in general we've demonstrated that we are focused on operating expenses. We want to make sure that every dollar that we're putting to work that we believe is being used wisely. So we've started the year with that cash expectation. We don't guide operating expense as you know but we've been able to increase our estimated cash position at the end of the year through a combination of unexpected payments we got earlier this year—$2 million we talked about on a previous call—and the balance of it really just reflects the disciplined spending environment that we put in place here under our new CEO.

Julie Simmonds, Analyst, Panmure Liberum

Lovely. Thank you very much.

Doug Swirsky, Chief Financial Officer (CFO)

Thank you, Julie.

Operator, Operator

Please standby for our next question. Our next question comes from the line of Jacob Johnson with Stephens. Your line is open.

Jacob Johnson, Analyst, Stephens

Hi. Good afternoon everybody. Maher at the end of your comments, you pretty deliberately talked about leveraging your infrastructure to sell a number of products. To Matt's question, it sounds like some of this is going to be kind of internal efforts and organic. But should we think about inorganic and M&A as a way to do that as well? Or were those comments designed to kind of suggest more of a focus on developing more products in house to bolt on to the platform?

Maher Masoud, President & Chief Executive Officer (CEO)

I think it's a combination of both, Jacob. The development of internal programs themselves are part of our current playbook. Throughout the year, we removed inefficiencies across the organization to make sure that we can begin to work on those organic initiatives that we believe will have high-value impact to our current and future customers. We also have a healthy corporate development group. When we think about other product developments, whether organic or inorganic, it needs to be part of our current structure: high gross margins and preservation of our healthy cash balance sheet are important. So whenever we're evaluating a product development opportunity, it's with the intent to increase long-term value and strengthen our financial position. We've built out the team internally to have that product development capability and the ability to assess technologies that can potentially become part of MaxCyte’s portfolio. So it's a combination of both.

Jacob Johnson, Analyst, Stephens

Got it. Thanks Maher. And then, Doug, you guys raised guidance and no good deed goes unpunished, so 5% plus core growth for the year. Obviously, that's a bit of a wide range with the plus on it. So at 5% that would suggest revenues would be down sequentially. Can you just—if that plays out—why would that be or any other thoughts about how we should be thinking about the fourth quarter?

Maher Masoud, President & Chief Executive Officer (CEO)

When we raise guidance one of the things we want to do is make sure that we are conservative and thoughtful. This is my seventh earnings call with the company and early on we had to walk back guidance in some periods. This year we took a very disciplined approach to setting guidance. We model a wide range of scenarios and pick a bottom parameter that we felt confident we would meet. In this case we are confident that we'll be north of 5%. I understand the math could imply being at the low end of the range would imply weaker sequential quarters, but we feel good about how things are coming together. We're only one month into Q4, so stay tuned. We wanted to establish a bottom threshold that we felt comfortable meeting based on the scenarios we ran.

Jacob Johnson, Analyst, Stephens

Got it, I'll leave it there. Thanks for taking my questions guys.

Maher Masoud, President & Chief Executive Officer (CEO)

Thank you, Jacob.

Operator, Operator

Please stand by for our next question. Our next question comes from the line of Paul Cuddon with Deutsche Numis. Your line is open.

Paul Cuddon, Analyst, Deutsche Numis

Thank you very much. I've got two questions please. Firstly, any learnings from the commercial launch of CASGEVY, just on how the instrument is working in the field on a commercial basis and any process that could be improved? And then secondly, with some customers moving towards in vivo gene editing, I'm wondering if you could reflect on recent data from any other customers on ex vivo gene editing and where you see the advantages there that will use your technology more in the future? Thank you.

Maher Masoud, President & Chief Executive Officer (CEO)

Great questions, Paul. On the CASGEVY commercial launch, we took the last few years before the launch to really prepare for it. We wanted to ensure that we were supporting them from regulatory, quality and instrumentation perspectives to ensure that there were no mishaps. The launch has gone very well so far. I believe it was announced that they are now manufacturing at another manufacturing site, which we will support as well. In terms of improvements, to be honest, I'm not sure there are many more improvements needed. We've had no mishaps on the launch and have fully supported them to ensure that not just our instrumentation, but also the processing assemblies are produced and manufactured to meet the ramp-up of any adoption curve for any therapeutic being manufactured on our platform. Regarding ex vivo versus in vivo, if you look at the complexity of what we're seeing in cell and gene therapies and how many edits are happening to cells, you're seeing the need for ex vivo editing even when there is in vivo delivery. For example, with Kamau Therapeutics they use CRISPR RNP to knock out DNA of interest via our electroporation system and use AAV6 to knock in DNA of interest. You're seeing complementary technologies; it's not necessarily ex vivo or in vivo alone. The complexity of engineering multiple steps is lending itself more and more to ex vivo editing as well. That's where our highly differentiated support—20 plus years of scientific expertise—comes into play. No one else has that level of expertise and that's why as the field gets more complex and grows, we're positioned to take advantage and be the premier electroporation and cell engineering company for therapy developers.

Paul Cuddon, Analyst, Deutsche Numis

Thank you very much.

Operator, Operator

Please standby for our next question. Our next question comes from the line of Dan Arias with Stifel Nicolaus & Company. Your line is open.

Rohan Walcott, Analyst on behalf of Stifel Nicolaus

Hi. This is Rohan Walcott on for Dan. Thanks for the time. I got two questions so bear with me here. On the SPL side, how should we be thinking about the duration period to take to sign an SPL agreement for small, mid and larger size companies? Because the smaller companies typically take a bit longer than the mid to large under the assumption that cash might not be as plentiful to spend. It might take longer to sign up a large player due to the more bureaucratic nature of a bigger company. And then secondly, how has the beta customer feedback been so far this year for the VLX platform? Hoping for more color there. Thanks.

Maher Masoud, President & Chief Executive Officer (CEO)

On the first question—small, medium or large—it's not so much the size of the company but demonstrating the scientific support that we provide from early research through process development. Typically you're looking at anywhere from 12 to 18 months of true partnership early on whether it's a small, medium or large-sized company. This field is highly scientific so having that scientific partnership early is key to why we're developing these relationships. Regarding VLX and early adopters, we're still working with early adopters and learning from them. We're not commenting in detail other than that we are learning how big the field is and how best we can support VLX customers. We're doing this in a methodical way, learning from early adopters before we assess how best to capture future VLX revenue.

Rohan Walcott, Analyst on behalf of Stifel Nicolaus

All right. Thank you, guys.

Operator, Operator

Thank you. Please standby for our next question. Our next question comes from the line of Tullyce Corman with Craig-Hallum. Your line is open.

Matt Hewitt, Analyst, Craig-Hallum

Yes. Hi. This is actually Matt. Can you guys hear me?

Maher Masoud, President & Chief Executive Officer (CEO)

We can hear you, Matt.

Matt Hewitt, Analyst, Craig-Hallum

Hey guys. So just I want to dig in a little bit more on the SPL side. I think you previously talked that it's 12 to 18 months on average from the beginning of conversations to when you sign these contracts. I think your most recent one would actually predate possibly the CASGEVY approval last year when you first started talking to them. With the approval, I would expect that you'd see increased interest in the platform. If so, those conversations that likely started in Q1 and Q2 or Q3, you're looking at potentially signing additional SPLs next year. I realize you're comfortable with 3% to 5%, I'm thinking through the chance you could see more than that next year given the excitement that's built because of that first approval. Am I thinking about that right?

Maher Masoud, President & Chief Executive Officer (CEO)

It's a good question Matt. That increased interest is real—we do have a healthier pipeline now than 12 months ago. However, SPL signings require demonstrating our scientific support, efficiency of editing and viability post-electroporation, which takes time—the 12 to 18 months. Sometimes it's faster, and we are seeing increased speed, but it's too early to say whether we'll exceed 3% to 5% next year purely as a result of the CASGEVY approval.

Matt Hewitt, Analyst, Craig-Hallum

Understood. All right. Thank you. And then maybe just a modeling question. I realize the write-down impacted gross margins here in the third quarter but your expectation is that those will bounce back to a kind of a normalized mid to upper-80s here in Q4? Or is there some further write-down that will occur or hit in Q4?

Maher Masoud, President & Chief Executive Officer (CEO)

We provided the non-GAAP measure to help strip out the one-time inventory provision and SPL Program-related revenue. Excluding those items, we were in the mid-80s gross margin. Last year had higher production as we brought a facility back online and that impacted margins. We're comfortable operating the business with very good margins; when you make those adjustments mid-80s is a reasonable place to think about the business. We're not giving quarterly guidance on margins but that's the context for modeling.

Matt Hewitt, Analyst, Craig-Hallum

Got it. All right. Thank you.

Operator, Operator

Thank you. Our next question comes from the line of Brendan Smith with TD Cowen. Your line is open.

Chad Wiatrowski, Analyst on behalf of TD Cowen

This is Chad Wiatrowski on for Brendan. Just in your discussions with prospective SPL customers, are you seeing any trends in terms of cell type or disease area?

Maher Masoud, President & Chief Executive Officer (CEO)

You are seeing a trend toward autoimmune diseases. Many more companies are repurposing or establishing programs focused on autoimmune indications, which lends itself well to the cell therapy space. Historically targets were more oncology-focused, but as the field expands you're seeing autoimmune programs and more complex edits to enhance persistence and durability in oncology as well. That's one of the early learnings: therapies are being engineered to have increased durability and persistence, and that's driving demand for our platform.

Chad Wiatrowski, Analyst on behalf of TD Cowen

I appreciate the stickiness of the customer base and how that's a competitive note. But when you're looking at other competitors, are you able to have customers switch when they're in the clinic? Or is that dynamic true for your competitors as well? Thanks for the questions.

Maher Masoud, President & Chief Executive Officer (CEO)

Great question. This year we converted two SPL customers who were previously in the clinic using a different electroporation platform to MaxCyte. The reason is our differentiated platform: higher efficiency, higher cell viability post-electroporation, and the scientific, regulatory and quality support that streamlines process development. We can show companies how to go from early research to clinical scale-up in a much shorter timeframe rather than taking nine, 12 or longer months to optimize from research to clinic. Those conversions are a testament to our scientific and engineering expertise. We're not just a tools company; we are a cell engineering company that helps companies get into the clinic and improves their potential for success.

Chad Wiatrowski, Analyst on behalf of TD Cowen

Thanks.

Operator, Operator

Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Maher Masoud for closing remarks.

Maher Masoud, President & Chief Executive Officer (CEO)

Thank you, operator, and thank you, everyone, for joining us today. We look forward to speaking to you again in the next earnings call in a few months. Thank you.

Operator, Operator

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