Earnings Call Transcripts
Operator: Good afternoon, and welcome to Cryoport's First Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. And I will now turn the call over to your host, Todd Fromer from KCSA Strategic Communications. Please go ahead.
Todd Fromer: Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors and elsewhere in our annual report on Form 10-K to be filed with the Securities and Exchange Commission and those described from time to time in the other reports which we file with the Securities and Exchange Commission. As a reminder, Cryoport has uploaded their first quarter 2026 in review document to the main page of the Cryoport, Inc. website. This document provides a review of Cryoport's financial and operational performance and a general business outlook. Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL Group and the related sale of CRYOPDP to DHL in June 2025, CRYOPDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment are now presented as discontinued operations. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport's fiscal year 2026 revenue guidance. It is now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.
Jerrell Shelton: Thank you, Todd, and good afternoon, ladies and gentlemen. With me today is our Chief Financial Officer, Robert Stefanovich; our Chief Scientific Officer, Dr. Mark Sawicki; and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. Our first quarter results continue to demonstrate our market-leading position as revenue was $47.8 million, up 16% year-over-year, which puts us off to a very strong start for the year. This growth is a combination of our momentum over the past several quarters across our integrated services and products platform. Revenue in support of our commercial cell and gene therapy grew 26% to $9.1 million, while revenue from clinical trials grew 18% to $12.9 million. We continue to support one of the industry's broadest cell and gene therapy pipelines and our leadership across both commercial and clinical programs positions us well for future sustainable growth. As of March 31st, we supported a record total of 766 global clinical trials, a net increase of 55 clinical trials over the prior year with 91 of these clinical trials in Phase III. From this market-leading base, we believe we will continue to drive robust growth in our commercial revenue in both the near and the longer term. During the first quarter, I'm happy to report that our client, Rocket Pharmaceutical received an accelerated approval from the FDA for their gene therapy, KRESLADI. With this approval, the number of commercial therapies we are supporting has increased to 21. For the remainder of 2026, based on current information, we expect another 10 BLA or MAA application filings and up to 8 additional new therapy approvals. Our Life Sciences Services segment delivered a strong quarter with revenue increasing 18% year-over-year, including 21% growth in BioStorage/BioServices. This performance reflects increasing adaptation of our full service portfolio in conjunction with the increasing scope and complexity of the cell therapy programs we support. It also underscores the critical role we play in supporting our clients with our extensive array of integrated temperature controlled supply chain services and solutions. Our Life Sciences Products segment also performed well, generating a 15% revenue growth driven by global demand for MVE Biological Solutions cryogenic systems. For over 60 years, MVE has provided high-quality, reliable cryogenic systems to the market. And every day, it continues to further reinforce its position as the global leader. For example, during the first quarter, MVE introduced its new Fusion 800 series, which is a self-sustaining cryogenic freezer that eliminates the need for a continuous liquid nitrogen supply feed, delivering exceptional reliability, safety and sustainability and a compact footprint designed for space-constrained environments, where a source of liquid nitrogen is not readily available. This is quite an accomplished engineering feat, which will pay dividends for years to come as we open up new markets that were heretofore and accessible, Growth across both our reporting segments, Life Sciences Services and Life Sciences Products, combined with a solid gross margins and continued operational discipline drove a $2.2 million year-over-year improvement in adjusted EBITDA from continuing operations, advancing us meaningfully along our pathway to profitability. We also reached a milestone moment during the first quarter as our IntegriCell team shipped its first cryopreserved clinical trial patient materials from both our Houston, Texas and [ Villers-le ], Belgium facilities for 2 separate clients. This achievement highlights IntegriCell's progress as it continues to develop and moves us a step further toward being a meaningful contributor to the cell and gene therapy industry and the Cryoport's future revenue and profitability. In parallel, we continue to advance our digital and information strategy, including initiatives in digitization and generative AI to support complex internal workflows and improving our effectiveness and efficiency in day-to-day operations. Our focus is currently on enabling employees to use secure enterprise-approved generative AI tools to automate repetitive tasks, analyze data in real time, manage risk and accelerate decision-making and execution. We are already seeing tangible benefits and believe AI will play an increasingly important role in our future. Reflecting on our strong performance for the first quarter and our increased visibility into the remainder of the year, we're raising our full year 2026 revenue guidance to $192 million to $196 million. We continue to review our guidance on a quarterly basis, and we will make any further adjustments as warranted. We also believe that based on our progress year-to-date, we will achieve positive adjusted EBITDA in the second half of this year. This concludes my remarks for today. Now I'll ask the operator to open the floor for your questions.
Operator: [Operator Instructions] And your first question comes from the line of Puneet Souda from Leerink Partners.
Puneet Souda: So you had a $3 million beat versus the consensus, but just you're raising the guide by $2 million. Just wondering how much of it is prudence being sort of early in the year? Any other considerations? And how should we think about 2Q, if you can provide some context there, just given the momentum you're seeing on the business and versus the core clinical trials?
Jerrell Shelton: Well, Puneet, thank you for the question. We think that Q2, of course, was an outstanding quarter, but we think it's a responsible guide given the continued uncertainty on a global macroeconomic basis. And we'll continue to evaluate this on a quarterly basis. And of course, we'll adjust the guidance if it's warranted in the future.
Puneet Souda: Okay. And maybe if I could switch gears to MVE, Life Science products, you had 15% growth. That was against an easier comp. So just trying to understand how should we think about growth for Life Science product MVE overall with the new product introduction there as well this year. Wondering if Robert can comment on that, too.
Jerrell Shelton: Well, Robert can comment on it, but I'll start. All products and life sciences, as you know, very well, take time to ramp up, whether it's products or its facilities. So it will take time for those products to ramp up in the marketplace and to have any kind of an impact. But we do think the markets are solid and have been -- they've solidified, and we see continued indications that to support that. And we think that we will have a high single-digit growth market going forward. Now we may exceed that from time to time, but that's kind of our assessment. Robert, you may want to add some things there.
Robert Stefanovich: Yes. And then just to further amplify, look, the outperformance in MVE during Q1 was really driven by strong demand across all geographies and solid performance, particularly in the animal health, but also life science overall. MVE is the #1 leader in the market worldwide. We already saw stability in 2025 in terms of return of product demand for cryogenic systems, and we continue to see that improvement as demonstrated in our Q1 performance.
Puneet Souda: Okay. Super. And then if I could ask one more on the -- obviously, we've seen improvement in biotech funding in the fourth quarter. That has continued so far in the first quarter. Just wondering if you're seeing some higher momentum from that for RFP volumes or other contract volumes here in the first quarter or the second quarter so far? Your clinical trials was up only -- net trial adds were only 6, but just wondering if you are seeing any momentum from -- or hearing further momentum from your customers given the funding environment?
Jerrell Shelton: Mark will take that.
Mark W. Sawicki: Yes, happy to. Puneet, Yes, I mean what we're seeing is we're seeing a definitive continued investment into Phase II and Phase III programs. And if you take a look, obviously, at our numbers, the Phase II data itself and Phase III data are increasing very, very nicely. I mean Phase III data was up 5 trials sequentially, which is very unusual and we haven't seen that in a long time. And Phase II continues year-over-year, Phase II is up almost 30 programs. And so a lot of that money is going into that and really is being invested in pushing these late-stage clinical assets over the finish line. So yes, we do see some very positive signs from that.
Robert Stefanovich: Yes. And Puneet, maybe just to add to it, it's less about the number of increase in clinical trials. It's really looking at the 766 clinical trials we're supporting. That's a very, very strong number. And looking at, as Mark mentioned, the maturation of those trials moving into Phase II and Phase III. Remember that the majority of cell therapies that are approved to date went directly from Phase II to commercial launch, and they're conducting their Phase III in parallel. So you really have to look at the 357 Phase II clinical trials and the now 91 Phase III as potential for commercial launches.
Operator: And your next question comes from the line of Anna Snopkowski from KeyBanc Capital Partners.
Anna Snopkowski: This is Anna on for Paul Knight. Congrats on a great quarter. I have 2 questions. But maybe to start, you mentioned you shipped your first clinical trial patient material for IntegriCell, which is very exciting. Maybe could you just walk us through your initial learnings from this rollout and what your expectations are for IntegriCell in 2026?
Jerrell Shelton: Yes, happy to. Yes, we're honestly -- yes, we're really pleased about the fact that we're now supporting actual clinical processes in both locations, both the site in Belgium, the site in Houston. it's a very nice achievement, and it's something that we've been working towards for a long period of time. So we've talked a lot about this over the last couple of quarters, but IntegriCell is as an organization and as an asset is going to be a very important driver for long-term revenue and margin expansion. It's a long cycle time for onboarding. It typically takes -- it could take 12 to 18 months in some cases to onboard. And so we do have active projects ongoing. We have additional clients that are coming on board now. And so our overall outlook is extremely positive. From a learning standpoint, it's been extremely well received. And I think one of the key elements here is the fully integrated platform, right? So our fully integrated service platform, which includes our biologistics, bioservices and our initial clients are using all of our service competencies. And I think that's a very important learning for our team as we harmonize and optimize those processes to really drive efficiency for our clients.
Anna Snopkowski: Great. And then maybe switching to the EBITDA side. Do you think you could walk us through some of the assumptions to get to those -- that 2H positivity. It seems like there's some facilities ramping, so that should help and then also the commercial therapies mix. But if you could just walk through some variables there and if there's any areas of upside, that would be helpful.
Robert Stefanovich: Yes, certainly. I think if you look at our Q1 performance, obviously, we're very close to breakeven on the adjusted EBITDA side with a negative $0.6 million. We certainly can reiterate reaching positive EBITDA in the second half of the year. This is obviously going to be driven by the revenue growth that we see. You mentioned some of the initiatives, the investments that we have. Those are really going to drive operating leverage in '27. So the achievements for Q2 of this year are really driven by the current organic revenue growth. The new facilities, those are investments we've begun in 2025, and we're completing now in '26. They're really going to drive further enhancement of our profitability and adjusted EBITDA in '26 and beyond.
Operator: And your next question comes from the line of David Saxon from Needham.
David Saxon: I'll echo my congrats on the quarter, a really strong start to the year. So in the script this quarter and last quarter, you talked about AI initiatives that are helping reduce OpEx. So I would love to understand just how durable that is and whether that can be applied to, I guess, more of the business? Or are we kind of seeing the full extent of the savings potential?
Jerrell Shelton: Yes, David, all of our AI initiatives are durable, and they're focused on internally to enhance our efficiency and our effectiveness within the company. It's another tool. It's a very powerful tool. It will reshape our business, I'm sure, over time, as it will on most other businesses as it has an impact on business and had an [ better ] impact on society. So we're very excited about our AI initiatives, but they're focused on practicality today on improving our efficiency and our effectiveness on internal operations.
David Saxon: Okay. And then maybe my second one might be for Robert. Just on the supply chain centers in Paris and Santa Ana, both in the second half. I guess what's baked into guidance from those 2 starting to come online when could we start seeing customer audits of those facilities? And then anything from a gross margin perspective we should be aware of?
Robert Stefanovich: No, absolutely. Yes. So look, these initiatives that we started in 2025 are going to be completed this year. One is the Paris, France site that we already went operational with our biologistics in November of last year. So that's already starting to ramp and clients are doing their audits. We're going to complement that with our bioservices services in Q3 of this year. And then the second one is the Santa Ana, California site that gives us obviously a significant West Coast presence. It's consolidating 3 of our current existing locations into one and expanding that to about 94,000 square feet to offer biologistics, bioservices consulting, testing and ultimately also have space for IntegriCell. So those are significant initiatives that we have underway that are really driven by client demand. And from a guidance perspective, the revenue contribution is obviously smaller because they're just going online in the second half of the year. Clients certainly will conduct their audits of the facilities this year, and they'll start contributing obviously more significantly in 2027.
David Saxon: Great. And anything on gross margin from that or just generally speaking, like how should we think about gross margin?
Robert Stefanovich: Yes. I think what we mentioned in our year-end, and that still applies, albeit we did come in higher on services gross margins than I had initially expected. But we did expect gross margins definitely in the second half to start rebounding, have some pressure in the first half of the year, which we didn't really see in Q1. But certainly, it will start coming back more significantly in the second half of this year.
Operator: And your next question comes from the line of Subbu Nambi from Guggenheim.
Ricki Levitus: This is Ricki on for Subbu. I'll keep it to one and a follow-up. So the commercial cell and gene therapy revenue grew 26% year-over-year in the first quarter. Would you say that's the right growth rate that we could think about for the year? Or should we expect more acceleration as newer approvals ramp? And is the growth concentrated in a few key therapies like CARVYKTI? Or is it broad-based across your support and commercial products?
Robert Stefanovich: No, I would -- on commercial revenue, look, if you look at in general research reports on the market, they will range anywhere between on the low end, 20% on the high end, 40%. I mean you're absolutely right, we saw solid revenue growth on the commercial side. We do expect that '26 will be a very good year for commercial revenue. And the guidance -- in terms of the revenue guidance is really based on the existing commercial therapies that we're supporting. So while there may be some revenue contribution from new approvals, the guidance really is looking at the existing platform that we have for 2026.
Thomas Heinzen: With -- sorry, it's Tom jumping in, Ricki. Bristol-Myers and J&J have already reported, and they did report a strong Q1. We can't really talk about the rest of our commercial therapies we support because they haven't reported their quarters yet.
Operator: And your next question comes from the line of David Larsen from BTIG.
David Larsen: Congratulations on the great quarter. Sticking with the idea or the theme of commercial products, can you just remind me how many commercial products you're supporting now? And did I hear you say that you could have potentially 8 more launch within the next 12 months?
Thomas Heinzen: We're supporting 21 today, Dave. And yes, there are 8 potential more approvals of new therapies this year. 5 of them already have PDUFA dates that's dates set by the FDA when they plan to make a decision.
David Larsen: And can you talk a little bit about the dynamics of a commercial product that you're supporting versus a clinical trial product? Like is there a difference in margins -- or is there any sort of difference in revenue per, I guess, product that you're supporting? I guess what I'm getting at is on the commercial side, since they're in the market being used, I would think that there would be much more revenue potential per product because it's basically being used across the world for patients. It's not limited to one specific clinical trial. So just any color there on the revenue potential and margin relative to clinical trials.
Robert Stefanovich: Well, I think there's a couple of things related to the commercial therapies. One, obviously, just the pathway from us supporting the clinical trials, we then work with their commercial team in preparing for the launch of the commercial therapies, whether it's in one country or globally. So we're part of the launch team in a way, and we provide program management that's built separately as well. But when you see the increase in commercial revenue, it's really driven by the patient population, right? So as more and more commercial therapies come to market, as more and more commercial therapies move from the teaching hospitals to regional settings or to the outpatient settings, so does really the acceleration of patients being treated occur, and this obviously drives more revenue. The other part is, obviously, we're continuously expanding our services platform. So initially biologistics, adding bioservices, ultimately adding IntegriCell cryopreservation services. So that further expands the revenue on a per patient basis as we provide our services along the supply chain of the cell and gene therapy market.
David Larsen: Okay. That's very helpful. And just one more quick follow-up. Obviously, your revenue growth this quarter versus, call it, 2 years ago, huge, huge positive this quarter, obviously. Just what do you attribute the resurgence in growth to? Is it simply a matter of the cell and gene therapy market coming back after everybody has worked through the IRA? Just what do you attribute this impressive growth to?
Robert Stefanovich: I think it's a number of things. One, obviously, as I mentioned, that we've broadened our revenue stream. So you saw bioservices, which is a newer offering, increase really over the last couple of quarters, 20% plus year-over-year, and we expect that to continue. On the product side, we do see, and we saw that in the second half of '25, demand normalizing and coming back. So there's really -- if we look at all of our different revenue streams, we're seeing stronger demand, demand picking back, and that's been driving revenue in the last 2, 3 quarters of '25 and also driven a very, very strong performance for Q1 of this year, which led us to increase the guidance for the full year.
Operator: And your next question comes from the line of Richard Baldry from ROTH Capital.
Richard Baldry: So curious on the commercial acceleration, if it's been concentrated around the CAR-T area with the regulatory burden sort of easing? Or if you think that's still a catalyst that's ahead that hasn't really had an impact yet?
Robert Stefanovich: The cell therapies are the majority of our commercial customers, Rich. The gene therapies have had -- I think it's kind of public out there and even start, but the cell therapies are pulling the wagon that's Bristol-Myers, Gilead, J&J.
Jerrell Shelton: And you look at our clinical trial portfolio, close to 90% of the clinical trials we're supporting are autologous allogeneic cell therapies.
Operator: And your next question comes from the line of Matt Hewitt from Craig-Hallum Capital Group.
Matthew Hewitt: Nice start to the year. Maybe first up, regarding the Fusion 800 series, could you talk a little bit about the pipeline? You mentioned a little bit about the positive response and obviously, a couple of patient adoptions already, but I'm just curious what that pipeline looks like.
Jerrell Shelton: It's kind of early to comment on the pipeline. We sell through distributors. And so the first thing we do is get our distributors excited about the Fusion 800, and they are. And so we're moving out very nicely, but it's early to comment on the pipeline.
Matthew Hewitt: Got it. And then maybe switching gears a little bit. Obviously, we're approaching a year since the REMS was removed. And obviously, there was a lot of buildup as they were moving the patients out of the hospital to some of these ambulatory and other centers. And I'm curious of that momentum that you initially saw, has that continued? Are you seeing that opportunity continue to expand beyond the core hospital setting? And if so, what can that mean for growth later this year and into next year?
Jerrell Shelton: Tom, you may want to comment on that?
Thomas Heinzen: Yes. It's definitely -- you can look in the companies that already reported J&J and Bristol and their outpatient growth and their community hospital growth is really helping to drive their revenue, which in turn helps to drive ours.
Operator: And your next question comes from the line of Mac Etoch from Stephens.
Steven Etoch: Maybe just a follow-up on the margin aspects that you all highlighted in the previous questions. MVE product margins were relatively light compared to our expectations. So I'd just like to get a sense of what you're seeing in terms of the storage industry in general and how energy prices are factoring into performance in the quarter and how that's expected to factor into the remainder of the year?
Jerrell Shelton: Yes. No, on the margin side, energy prices have not factored into the quarter for our products business. It's really purely a result of specific product mix. If you look at year-over-year margins, they're pretty close to each other. Sequentially, it's down, but it's really related to product mix that we typically see, especially in the first quarter of the year. So there's no really -- there's no pricing erosion or competitive element. It's product mix related.
Steven Etoch: I appreciate that. And it's been, call it, 6 months since funding really started to tick back up. As you look at how 2Q is shaping up quarter-to-date, what can you tell us about the level of activity and sentiment that you're seeing within your customer base today?
Jerrell Shelton: I think overall, it's obviously very good for the industry and especially for companies that are in need to raise funds to drive their clinical trial portfolio. Look, a lot of the clients that we serve are very well established, very well funded, especially look at the huge number of Phase II and Phase III we have. They're really getting close to the finish line pre-commercial. So I don't think that we see a huge risk there on the funding side. It's really mostly on smaller companies in need of funding and it's certainly good for the industry to see funding coming back with strong, strong funding, especially in the month of April of this year.
Robert Stefanovich: Maybe to just peek under the hood a minute with our clinical trial count, it increased by 6 net sequentially. However, there were 29 new trial adds in the quarter. and 23 removed, there's the net 6. But of those 23 removed, 16 of the trials were completed. That's a great thing that shows the maturation of our pipeline. That means ones are going to go to 2 and twos are going to go to 3.
Operator: And your next question comes from the line of Matt Stanton from Jefferies.
Matthew Stanton: Robert, maybe just one to close the loop on margins. Just given some of the inflationary pressures we've seen over the last few months on commodities and logistics side, can you just help remind us your pricing structure? I believe you're able to pass along that uptick as part of the contracts in place. But can you just kind of remind us the mechanics on the pricing side as it relates to some of the inflationary pressures coming back into the P&L type and the macro for the rest of the year?
Jerrell Shelton: No, that's a very valid question. Look, in transportation and logistics, so that component of our solution, fuel surcharges are the norm. So it may go up or down, but fuel surcharges are passed on to our client base. That's common business practice. So it does not impact our gross margins as a company. And from a product side, we really haven't seen an impact from the increased prices, oil prices at this point. But we're certainly keeping an eye out on it like everyone else.
Matthew Stanton: Okay. And then maybe just on the product side. I think, Jerry, you said that market could grow high singles. I think prior, you guys thought products could maybe be mid-singles for the year, maybe high singles if things kind of came back better after a strong 1Q, do you feel like products is more like a high single-digit business in '26 than mid-singles for you? I just want to clarify that in terms of what you're penciling in for product growth in '26.
Robert Stefanovich: No, I do feel like it's high single growth -- high single-digit growth, Matt. It seems like it's solidifying in every aspect across the globe. So I have no reason to think any differently.
Matthew Stanton: And maybe, Mark, just one for you to go back to IntegriCell. Now that you've seeing the customers in those 2 sites start to actually move product, any finer point you can talk to just in terms of the volume or the size of product you expect there? I know it takes a while to kind of get things validated and started. But now that they're started, I guess, how meaningful even though it's a couple of customers could that kind of be as IntegriCell ramps up? I think prior, you had been pretty bullish in terms of the revenue opportunity given the number of kind of products and services you're pushing through as part of IntegriCell.
Jerrell Shelton: Matt, we are bullish. We're bullish about everything that we do. And every -- since we formed the company, we've set standards in the industry. IntegriCell is another example of our industry-leading movement forward based on what the markets need, based on conversations with clients and what they need. IntegriCell is off to a good start, I would say. And we always -- we would like to have a more robust start no matter what it is. But it's off to a very good start right now and it's gaining a lot of attention. But it does take time for these things to take hold for other clients to come in and for our integrated services approach to take effect. So stay tuned. As Mark said, it will be unquestionably a very important contributor to Cryoport in the future.
Operator: There are no further questions at this time. I will now hand the call back to Mr. Jerry Shelton for any closing remarks.
Jerrell Shelton: Thank you, operator. Ladies and gentlemen, thank you for your questions and our discussions. They've been very good. I appreciate them very much. In closing, I'd just like to remind you that we continue to be the market leader, and we have had a great start to 2026, marked by 16% revenue growth year-over-year and strong double-digit growth across both our reporting segments. Our Life Sciences Services segment grew 18% year-over-year, driven by 21% growth in BioStorage/BioServices revenue, a 26% increase in revenue from commercial cell and gene therapy support and clinical trial-related revenue growth of 18%. And at this time -- at the same time, rather, our Life Sciences Products segment grew by 15%, driven by global demand for MVE's cryogenic systems. Remember, MVE is the world leader in cryogenic systems. Our top line growth was accompanied by solid gross margins contained operating and continued operational discipline, which resulted in a $2.2 million year-over-year improvement in adjusted EBITDA from continuing operations, pushing us further down our pathway to profitability. Based on these results and the progress we have made with our strategic initiatives, we're more positive on our outlook for the year than when we last spoke to you in our year-end earnings call, and that's led us to raise our full year revenue guidance as we continue to see opportunities ahead of us. We look forward to keeping you up to date on our progress. We thank you for joining us this evening. We appreciate your continued interest and support, and we're looking forward to speaking with you again when we report our second quarter financial results. We wish all of you a good evening.
Operator: This concludes today's call. Thank you for participating. You may all disconnect.