Good afternoon, and welcome to Cryoport's Fourth Quarter and Full Year 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Fromer, from KCSA Strategic Communications. Please go ahead.

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 fourth quarter and full year 2025 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 and the related sale of CRYOPDP to DHL, CRYOPDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment are now presented as discontinued operations. Cryoport previously provided quarterly historical information on this basis for fiscal year 2024 and our first quarter 2025 in review document, which remains available on the Cryoport, Inc. website. This information is intended to support the financial modeling efforts of those needing this type of information. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport's fiscal year 2025 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.

Thank you, Todd. We have a great report for you today, ladies and gentlemen. But before we begin, with us this afternoon 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. Today, we reported our full year results for 2025, which was a year of strong progress for Cryoport. We delivered full year revenue from continuing operations of $176.2 million, exceeding the high end of our prior guidance and reflecting continued momentum across our core markets. In the fourth quarter, we again achieved double-digit revenue growth driven by expanding commercial cell and gene therapy activity and revenue from the support of commercial cell and gene therapy increasing 29% year-over-year to a record $33.4 million for the year. Commercial cell and gene therapy revenue in the fourth quarter represented 20% of our overall revenue, while clinical trial revenue remained solid, growing 14% year-over-year to $47.1 million. We concluded 2025, supporting a record 760 clinical trials and 20 commercial therapies worldwide. Our clinical trial support showed a net increase of 59 over the previous year and represented approximately 70% of total trials for the cell and gene therapy industry. Looking ahead to 2026, based on the information that we have, we anticipate another 13 BLA or MMA (sic) [ MAA ] application filings, including 2 of which have already been filed, 9 new therapy approvals and an additional 2 approvals for label or geographic expansion. In the near term, Cryoport has 3 customers that are anticipating new therapy approval decisions in March and April of this year. We believe our clinical trial pipeline is spring loaded with 86 clinical trials in Phase III and 361 clinical trials in Phase II. Remember, most of the cell…

[Operator Instructions] Your first question comes from the line of Puneet Souda from Leerink Partners.

So first one, Jerry, or maybe for Robert. The guide that you have high single-digit, nearly 9% at the midpoint for the year -- could you elaborate a bit more on that? And in terms of the segments, how should we think about the growth in biologics and the services and the MVE? And given the commercial momentum, commercial therapy momentum that you're seeing, how should we think about that growth in -- for the full year? And I have a follow-up.

Okay. So there are several questions in that request, Puneet. So I'd like to start to kind of parse those questions. So your question -- the first one is how we feel about -- that was your last point about how we feel about the growth of cell and gene therapy for 2026. Is that correct?

Yes. Well, on the commercial side, I mean, what's your growth expectation for commercial therapies? And then also, if you can provide more color on the segments, each of the segments, the BioLogistics, BioStorage, and the MVE?

Okay. So I'm going to start with the last question first, and I'm going to turn it over to Mark, okay, because he has a view on this. But we do expect continued progress with our existing customers, and we do expect to be bringing on other commercial therapies during the year. It does take time for them to ramp up, but they will have some impact. And some of those that we've already brought on will have a continuing impact. And Mark can name some of those names perhaps, but we do try to avoid commenting directly on customers' business. So in general -- let me turn it over to Mark and let him answer the rest of that.

Yes. So Puneet, obviously, we typically don't furnish guidance on composition by type. We did increase our commercial revenue by 29% in 2025, and it's now eclipsing 20% of our overall revenue. Looking at '26, we do expect to have another good year in '26, although we haven't disclosed the percentages associated with the commercial revenue at this point.

Puneet, there's no doubt about it that commercial therapy will be the driver of our future. I mean, it is the fastest-growing market. And as I mentioned earlier, we're forecasting 9 new therapies in 2026, and we're -- furthermore, we're forecasting 11 BLA/MAA filings to take place. As I mentioned in my comments, we think we're spring-loaded. We have 86 trials in Phase III. And then we have that -- I think it was 391 in Phase II. So we're spring-loaded for a brilliant future. And even if half of those in Phase III are approved, it's a fantastic for us. So...

Maybe just to add to it, we've grown in all of our service lines, and we've grown on our product side as well. We expect to continue to see growth really in all of our product lines and service lines. We always talked about services growing double-digit, obviously, commercial therapy being the strong grower within that. And then on the product side, single-digit growth, mid-single-digit growth, potentially high single-digit growth depending on how the demand is coming back.

So on your second part of your question, Puneet, and if I've missed anything or we've missed anything, you can come back. But second part of your question on BioStorage/BioServices. BioStorage/BioServices grew by 22% for this past year. We're very pleased with that. And it will continue to grow. In fact, we think it will pick up growth. I'm certain about that. And of course, it is driven by cell therapy approval. So it's a bright future for BioStorage/BioServices. The third part of the question -- please go ahead, Puneet.

Yes. On the -- just on the MVE segment too, I mean, you had 2% growth, I believe, in the quarter. And -- correct me if I'm wrong. And how should we think about that?

Yes, we had -- we were up 7% for the year. And MVE is doing well. I mean, it's got -- we try to create these fountains of innovation throughout the company to make sure that we're moving ahead. MVE has introduced its -- the integrated monitoring systems that I mentioned during my comments, but more -- equally important are the things that will be introduced in this next quarter or in this quarter, as a matter of fact. So -- and we've introduced the Cryoverse. So you're going to see MVE also adding some services to the product that is producing. But remember that Fusion 800 opens up a vast new market for us. I mean, vast because there are many facilities on second floors in countries around the world that can't get a large freezer on that second floor that need a large cryogenic freezer. Hospital pharmacies will like this product as we move forward and as allogeneic therapies are developed.

Super. And then just a quick clarification on Q1. Any color you can provide there would be helpful. Just -- and I wanted to know if there are any flight cancellations disruption from any of the geopolitical flight cancellations that you're expecting in Q1?

There's nothing that we're expecting in terms of cancellations. And today, there's been minimal impact on us. So nothing to report there at this time.

Got it. And then color on Q1?

Yes, we've had a solid start to Q1, Puneet. We're not expecting a light one like some other life science companies are.

Your next question comes from the line of Anna Snopkowski from KeyBanc Capital Markets.

Congrats on a great quarter and a nice guide for '26. So maybe to start, you mentioned in your prepared remarks that total biopharma funding and CGT funding, in particular, saw the strongest funding month in December in the past 4 years, I believe. So I was wondering what the usual lag is between the funding environment and maybe your customer conversations or orders? And then a quick follow-up.

Yes. So obviously, funding is dependent on the client. But on average, you'll typically see that kick in after about a half a year time frame. Some may be a little bit quicker, some may be a little bit slower, but it's a good average for you to consider.

Perfect. Then maybe just touching on the margin side of things. You mentioned that you expect positive adjusted EBITDA, I think, in the second half of '26. So could you just outline how you expect to get there and what operational or cost reduction milestones need to happen in order to achieve this?

Yes. It's really less about cost reduction milestones. You may recall in '24, early '25, we did take some initiatives and operational initiatives to drive improvements, and that was quite successful where we improved adjusted EBITDA of about $12 million year-over-year. We are starting to invest in specific growth initiatives, and completing some of the initiatives that we commenced in 2025, in setting up our Global Supply Chain Center in Paris, and setting up our Global Supply Chain Center in California, which we're going to consolidate 3 locations and expand our footprint there to include BioService and IntegriCell. We obviously have a lot of insight with our client base. If you kind of step back and look at how we're positioned, it's really an unmatched positioning. We serve about 70% of clinical trials, have a record 670 clinical trials, and we support 20 commercially approved therapies for which a majority are cell therapies. So we have a lot of insight as to what's to come. We've been very successful in expanding our service offerings into BioServices, where we've seen strong growth. And so that expected growth, together with some of the efficiencies that we've identified will really drive the further margin improvement.

Yes. I just want to comment on the pushout of the adjusted EBITDA positive numbers out of the end of '25. Just want to -- so one of the key elements here is that we've seen specific client requests to accelerate certain business opportunities. And so our site in Belgium is a very good example of that where we had to build out in a very rapid time frame, GMP-compliant sterile kitting services for one of the very large volume commercial accounts. That is actually up and running. So we were able to do this in record time, commissioned the site in December, and it is now contributing revenue, which will ramp significantly over the next few years. So we do still have to remain a little bit opportunistic on these types of opportunities, because they'll benefit the organization in the long-term.

Your next question comes from the line of Subbu Nambi from Guggenheim Securities.

Within the 2026 guidance, can you speak to what you expect from the macro environment or at the low end and the high end of your revenue guidance range?

In terms of -- I mean, obviously, if you look at the macro environment, it's quite volatile. If you look at specifically the markets that we're addressing, those have been progressing very nicely in spite of some of the challenges within the regulatory agencies and the macro environment. If you look at clinical trials, we had a record increase year-over-year in clinical trials, and we see a lot of interest for the services that we're providing. So I think there's certainly an opportunity to beat the guidance that we're giving if we see some of the acceleration happening sooner. I think the downside risk is really the same thing as for all other companies. It's more of the unknown of what may happen. But we don't really have specific risks identified at this point in time, and we feel quite comfortable with the guidance that we're providing.

As a follow-up, you discussed the outlook for FDA approvals, but what is assumed in the guidance for animal health and reproductive health growth contributions?

Yes. We don't typically disclose our segmentation by product segment. So I'm not sure -- and that's not something we typically outline.

Yes, it's moderate growth. I think the real growth drivers for us as a business is clearly the cell and gene therapy space on the services side. And then within that, in terms of growth drivers, it's really further advancing the commercial cell therapies. There's a number of activities, some happened in 2025, the removal of the REMS requirement, which really started to -- we started to see our clients accelerating their therapies into the outpatient setting. And that's a significant move, which portends to higher number of patients being treated, and that again translates into additional revenue to us.

Your next question comes from the line of David Saxon from Needham.

Just two for me. I wanted to follow-up on some of the comments earlier about product growth. I think last quarter, you were kind of feeling good about high single digits for '26. It sounds like you might be thinking more around mid-single-digit growth for the year. So can you just give an update on MVE, the pipeline, the outlook there? Like was there any incremental softening since last quarter? Is that just kind of conservatism baked in?

David, I think that we pretty much addressed that we thought that we think our guidance is a good starting point for the year. There are a lot of macro risk out there, and we did assess those. And so our starting point for our guidance is that $190 million to $194 million, and we think it's a good starting point. MVE continues to work on a stabilized basis. It's got a great forecast to budget for 2026, and it has innovation coming out of it on a constant basis now. So we think MVE is in good condition, but we're not forecasting growth more than the higher single digits, 7% to 8%.

Okay. And then I wanted to follow-up on some of the partnerships. Obviously, DHL, I guess, can you give an update there? Like is everything fully integrated and at a point where you can start to really see the benefits come through? And then you also mentioned Cardinal and Parexel. Can you just double-click there, like frame those and...

Yes. Let me talk about DHL first. If you look, DHL is a lumbering -- big lumbering organization. And I've got -- I want to go back to one of your points, your question a little bit earlier or comment, but after I talk about this. But DHL is a large -- very large organization, 600,000 employees spread all over the world. It takes time for them to mobilize and to -- and they don't act -- they can't operate as agilely as we do. So it's going to take time for that relationship. That's why I said the promise of in terms of EMEA and Asia Pac and that impact. We are doing some things with them already. And we do have some cooperative endeavors underway. But for the full effect, it's going to take a while for that to roll out. I'm going to let Mark comment on Cardinal and Parexel. But before we do that, you were talking about MVE and the 7% growth and all that kind of stuff. Yes, I just want you to remember, the driver for this company is commercialized cell and gene therapies. And that -- as that happens, that will dwarf MVE. MVE is a crucial part of our business. It's a foundational business. It's an important company, and it's healthy and it has great cash flow. It has innovation. It's 70% of the market. It's the world leader. But it is -- it will not be as significant in terms of revenue proportionality in the future as it is today because cell and gene therapy will outgrow it. And now Mark can comment on those partnerships we have with the other 2 programs.

Yes. So obviously, what we're doing is focused on building out an ecosystem that supports the cell and gene therapy global environment. And one of the key elements of that strategy is to really define very strong partnerships with leading entities in the space that are complementary to what we do, but don't conflict with what we do. And Parexel and Cardinal Health are 2 very good examples of that. So Parexel is a large CRO that really focuses on clinical trial design, FDA advisory services and clinical engagement. And then Cardinal Health is obviously order to cash management, reimbursement, regulatory support and then patient and provider support. And so us working closely with them really allows our mutual client base to have a best-in-class product offering. Folks like Cardinal and Parexel have come to us because we are best-in-class from a supply chain services standpoint. These help drive the industry. And so we're focused on long-term partnerships that help drive standardization and efficiency of the industry over time.

[Operator Instructions] Your next question comes from the line of Mac Etoch from Stephens.

Maybe just one for me. I think you highlighted on your prepared remarks that a large portion of these therapies are getting approved out of Phase II already. And with the FDA officially moving towards like a default 1 pivotal trial, how do you anticipate this change impacting approvals and investments over the near term?

Tom, why don't you take that question?

I was going to let Mark do it.

I heard you say.

All right. Anything that's going to streamline the process, Mac, is a good thing in our view. It's about more patients getting treated on the commercial side. Commercial revenue is higher than clinical revenue because there's typically more addressable patients for a commercial therapy than a clinical trial, but I'll let Mark opine.

Yes. So obviously, I mean, if they follow through with a single pivotal and don't require a follow-up, that's beneficial to us. If they come back and require additional follow-up, then obviously, that may slow things down. But if you combine it with some of the other elements, in particular, the REMS requirement changes, that's going to be a huge driver for us because that really allows us to push into the community care setting and our client base. If you recall, the vast majority of the addressable patient population is still in the community care setting. And so it provides a significant opportunity for upside on the already existing commercial products as well as the new ones that are coming to market.

Your last question comes from the line of David Larsen from BTIG.

Congratulations on a good quarter. Can you talk about the MVE or product revenue growth in the fourth quarter? It looks like it was up 2% year-over-year. For the year, it was up 7% year-over-year. So it looks like it maybe slowed a little bit in the fourth quarter. Why was that? And what will sort of drive the reacceleration in growth in '26?

David, you can't look at MVE systems on a quarterly basis and make too many judgments. I mean, the decisions for purchase of capital equipment that MVE manufactures is cryogenic systems is planned over a period of time. And many times, it's highly engineered in terms of the setting that it's going into the installation and its purpose. So it's difficult to look at it. You're better off to look at an annual growth rate or a moving 12 months if you want to look at it as moving 12 months. But MVE is solid. It's a solid company and the markets seem to be -- and we certainly are trying to help stabilize those markets and there's nothing more to add there other than if you have some comments, Robert. But I think that's the summary.

Yes. And just to give you maybe a little bit more granular picture of 2025. When we looked at kind of the market growth and MVE starting to come back and demand starting to come back, we've seen that both -- on both sides of the product portfolio, the cryogenic freezers as well as the cryogenic transportation and cryogenic dewar portfolio. So -- and then from a regional perspective as well in the various quarters, we've seen really all 3 regions at certain times starting to see a pickup in demand. So certainly, it's a departure from what we've experienced in '22, '23. And then with that, our guidance does assume some moderate mid-single-digit type of growth rates for '26.

David, I want to remind you of one other thing, and this is just a matter of explanation so that you're aware of it. I mean, MVE furnishes both Cryoport Systems and Cryogene with products, with cryogenic freezers as well as dewars. The number you're seeing, the 7% for the year, for example, is a net number. It doesn't include its sales internally. But -- so I just wanted to point that out.

Okay. And then 5 years from now, what percentage of total revenue do you think could be coming from commercial?

You'll have to -- we'll come back and talk with you about that. I can't tell you right off hand right now. And we don't -- I don't have a forecast for that. There's too many uncertainties right now for 5 years out; 5 years is a long time in this business.

Yes. We do model everything out, right? So -- but as the time frame goes out, there's more uncertainties that creep into the modeling, in particular, around the timing of new product launches and their adoption to the market. There's been products where the consensus from a market standpoint was this would be a very high-growth, high traction product and it disappointed, or vice versa. There have been a couple of sleeper surprises where folks didn't anticipate much out of the product, and then it came in a lot stronger than anticipated. The key here to think about is, again, the portfolio effect, right? And so our focus is around capturing the plurality of the clinical market and then holding it through commercial activity and a commercial launch. So we're currently supporting 20 commercial products. You've seen the positive benefit over the last 12 months of that commercial portfolio, where our commercial revenue has been extremely strong from a growth standpoint. And we have a very strong prognosis on portfolio clients. We've already talked about the potential of another 9 approvals this year as well as additional geographic and market expansions. As you look out further, that continues to expand out. And if you're looking at the support mechanism of those -- of our Phase II and Phase III programs, a significant percentage of those will have a decision from a regulatory standpoint over the next 3 to 4 years, which will really impact those numbers fairly dramatically, assuming that we get a reasonable return on commercial approvals. Then you have to also look at, obviously, the impact of the REMS and the community care engagement, which is going to be a huge factor as it relates to what that growth rate looks like. If our partners are successful in driving into the community care setting and the leader on that is really Janssen and CARVYKTI product where they've published data that shows that they're in the mid-30s now on a community care engagement standpoint. If they push that up to 50%, 60%, 70% and you have others that are doing the same, that's going to have a significant material impact, not only in the existing commercial products, but the new ones coming to market.

David, just a couple of other comments. I mean, while to add to what Mark is saying. I think you can undoubtedly say that in the future that we -- that cell and gene therapy, commercial cell and gene therapy revenues will be the dominant factor. It will be the dominant factor in our revenue. It will be by far and because it drives not only the BioLogistics, it drives the BioStorage/BioServices. You saw in this last quarter, I think it was a quarter we grew about 23%. And what you're going to see over time is you're going to see as cell and gene therapy picks up, that is the commercial therapy approvals happen, you're going to see our growth rate come more in line with the growth of the industry because we -- the lower growth segments, which are foundational to what we do, will be less of a proportion. So it's an interesting question. I just don't -- we don't have a specific answer, but directionally, we know where we're going. You have something else to add, Mark?

Yes. I just want to point out, if you go to Slide 6 in our presentation deck, that will give you some market data that should give you a reasonable understanding of the opportunity associated with our commercial portfolio at this point.

There are no further questions at this time. So I'm going to turn the call back to the management team for closing comments. Please go ahead.

Okay. One second. I wasn't prepared for that. Okay. Well, thank you for your questions. Very good questions and good discussion, and we appreciate those questions. So in summary, we made some significant strides in 2025 with solid results showing full year revenue performance above guidance. Our Life Science Services business segment grew 18% year-over-year, including 22% increase in BioStorage/BioServices revenue and a 29% increase in revenue from commercial cell and gene therapy we support. We concluded 2025, supporting a record 760 clinical trials and 20 commercially approved cell and gene therapies worldwide. Of the 760 clinical trials we support, 86 are in Phase III and 361 in Phase II, creating what we believe is a spring-loaded position to future commercial cell and gene therapy revenue streams. In addition to our financial performance, we continue to advance targeted strategic initiatives, which are designed to strengthen our growth trajectory in 2026 and beyond. Based on our market position and industry insights, we are encouraged by the opportunities ahead, and we will continue to keep you updated on our progress. Thank you for joining us on today's call. We appreciate your continued interest and support and look forward to speaking with you again when we report our first quarter financial results for 2026. We wish you all a good evening. Operator?

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