Cryoport Q3 2025 Earnings Call - Strong Double-Digit Growth Amid Macro Uncertainties

Operator: Good afternoon and welcome to Cryoport’s Third Quarter 2025 earnings conference call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. 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.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: 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 Third Quarter 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 general business outlook.

Before I turn the call over to Jerrell, please note that because of the strategic partnership that has been established with DHL Group 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 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 values. It is now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerrell, the floor is yours.

Jerrell Shelton, Chief Executive Officer, Cryoport: Thank you, Todd, and good afternoon, everyone. 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. During the third quarter, we continued our strong momentum, delivering double-digit growth in both our Life Sciences Services and Life Sciences Products segments. Notably, revenue from our support of commercial cell and gene therapy grew 36% year-over-year to $8.3 million, driven by the continuing global adaptation of these lifesaving therapies. It is imperative that the growth of the— It is impressive, rather— it is impressive that the growth of the regenerative therapies market, which we believe is still in a very early stage of development, has remained resilient despite ongoing challenging microeconomic, political, and geopolitical backdrops.

Within Life Sciences revenue increased 16% year-over-year and represented 55% of our total revenue from continuing operations for the quarter. This included a 21% increase in the biostorage bioservices revenue, underscoring the persistent demand for our integrated platform. Driving this growth is the rising prevalence of chronic and rare diseases coupled with continued advancements in cell and gene therapies targeting solid tumors and autoimmune diseases. We are also encouraged by signs of stability in our Life Sciences Products market, where revenue grew 15% year-over-year, driven by improved demand for our market-leading cryogenic systems. In the third quarter, we expanded our product portfolio with the launch of MVE Biological Solutions Next Generation SC 4/2V and SC 4/3V vapor shippers. These cryogenic shippers models have been redesigned, utilizing innovative technologies to offer customers added protection during extended or challenging shipments and include several key advancements designed to enhance the performance and reliability.

MVE’s newly designed condition monitoring solutions for these shippers are integrated with each unit, combining our trusted cryogenic systems with advanced real-time condition monitoring technology supplied by Tech4Med, another Cryoport company. These innovations reflect MVE’s unwavering commitment to support the Life Sciences with advanced intelligent connected assets to safeguard vital biological materials. Beyond our core systems and services, we are progressing on a number of other growth initiatives designed to better serve our clients and diversify our revenue streams. These initiatives include the onboarding of our first clients for IntegriCell, our cryopreservation services located in Liège, Belgium, and Houston, Texas. These cryopreservation services are designed to address a critical aspect in optimizing the supply chain for the development and commercialization of cell-based therapies through high-quality, standardized cryopreserved starting materials. We’re excited by IntegriCell’s recent progress as it moves forward to become a significant revenue and profit generator.

Additionally, in late October, we opened the logistics portion of Cryoport Systems’ new state-of-the-art Global Supply Chain Center at the Charles de Gaulle Airport in Paris, France. This 55,000 sq ft facility provides us with increased ability to serve our clients in the European and global markets. It is designed to support complex life sciences supply chain needs, including biologistics, bioservices, and future cryopreservation services. An official grand opening is scheduled to celebrate the launch of this facility. It will be held on November 20th, with bioservices opening in mid-2026. In addition, we are also advancing toward opening a Global Supply Chain Center in Santa Ana, California, which is expected to come online in the second half of 2026. This facility will consolidate three existing locations and feature next-generation technology to optimize operations and client support.

Complementing all of these activities, we have begun implementing our recently established strategic partnership with DHL Group. Due to DHL’s size, this strategic relationship will take some time, and when completed, it will enhance our positioning in the APAC and EMEA regions and reshape our competitive profile within the industry by leveraging DHL’s global scale and capabilities. Regenerative medicine has been advancing steadily, largely driven by the expanding pipeline of regenerative therapeutics entering clinical development and commercialization. Despite any short-term headwinds, cell and gene therapies have continued to enter and move through the clinical pipeline, which should ultimately result in growing revenue from commercially supported therapies.

Cryoport’s temperature-controlled supply chain solutions are supporting the largest portfolio of clinical and commercial gene therapies in the world, with a record total of 745 global clinical trials, and 83 of these in phase three, representing approximately 70% of the cell and gene therapy clinical trials. In the third quarter, four BLA/MAA filings occurred, and three more were filed in October. For the remainder of 2025, we anticipate up to an additional seven application filings, one new therapy approval, and two additional approvals for label or geographic expansions or moves to earlier lines of treatment. Of course, the timings of these filings may be impacted by the current government shutdown of the FDA in the United States. While global trade conditions remain dynamic, Cryoport did not experience any new material impact from tariffs in the third quarter.

Furthermore, we have, of course, taken steps to diversify our supply chain to mitigate potential impacts that could come as a result of tariffs. Impacts not covered by these mitigations are covered by surcharges. With strong momentum we have achieved year to date and our progress across the board, we are updating our full year 2025 outlook for total revenue from continuing operations to the range of $170-$174 million. Our team is dedicated to building long-term value for our shareholders. Cryoport is maintaining and growing its competitive differentiators as the only pure-play end-to-end temperature-controlled supply chain platform that supports the largest portfolio of clinical and commercial cell and gene therapies globally. This concludes my remarks. I’ll now ask the Operator to open the lines for your questions.

Operator: Thank you, ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speakerphone, please flip the handset before pressing any keys. Your first question comes from the line of Kyle Crews from UBS. Your line is now open.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Thank you for taking the questions and congratulations on the quarter. Maybe just to start, the high-end of guidance implies a sequential decline in revenues. At the same time, you know you’re seeing positive momentum across the entire business. You have an increased number of commercial therapies supported, a higher number of clinical trials, and you’ve launched new products within MVE. Can you help us reconcile that with the implied sequential decline in guidance? And then for a second question, can you discuss if the recent release of the triple FDA draft guidance that supports making clinical trials easier has resulted in an uptick in clinical trial interest at your company? Thank you.

Jerrell Shelton, Chief Executive Officer, Cryoport: You had a lot of questions in there, and I think Robert will start answering your financial questions, and Mark will address your FDA questions.

Robert Stefanovich, Chief Financial Officer, Cryoport: Yeah, happy to. Yeah, look, you’re certainly right in terms of how you phrased the question. Given all of the macro uncertainties right now, we think it’s a responsible guide. It balances the momentum that we are seeing versus the macro conditions such as the current government shutdown and the ever-changing tariff landscape. I think we’ve managed it to date very well, and we’re obviously, of course, focused on profitable and disciplined growth. If you look at the revenue guidance and the increase in revenue guidance, it represents about 8%-11% revenue growth over the prior year from continuing operations, but as you said, at the same time, we continue to be very bullish on our market-leading position.

We feel that our long-term growth rate will be close to that of the cell and gene therapy market, as you can see in our Q3 performance, and as more and more commercial therapies come to market. In fact, if you look at our commercial revenue right now, it’s already a fairly significant portion of our total revenue. I think it’s roughly about 18%-19% of total revenue, so we’re trying to balance those two parts. One, the cautious view on kind of the macro uncertainties, but yet at the same time, we are very bullish in terms of the outlook and bullish in terms of finishing the year strongly.

Jerrell Shelton, Chief Executive Officer, Cryoport: Mark, you want to answer the FDA portion?

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Sure. Assuming you’re referring to the REMS requirement, is that correct?

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: No. They recently released three new draft guidances relating to clinical trials.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Oh, okay.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Yeah.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Yeah. So obviously, yeah. So. The draft guidance announcements that you’re talking about that came out recently, some of them are targeting some generic small molecule programs. Those don’t have a significant bearing on our market. Those that are aimed at the orphan markets and those that are focused around driving biologics approvals much more quickly are impactful to us and our clients, and we do believe that those will help drive more activity in the future from a BLA standpoint. Just turning to REMS, because I think it’s important to understand that one too. So the REMS requirement, which has been also. One that’s been announced, that’ll have an even more impactful. Positive impact for us. As it’ll drive the implementation and utilization of cell therapies into the community care setting.

And I think if you look at both BMS’s and J&J’s Carvykti revenue in Q3, both of them had very strong growth. And in fact, Carvykti folks even came out and said. Almost 80% of the patients are being referred from community oncology centers at this point. So I think those both are very predictive of strong growth in the near future.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Great. Thank you for that, and then maybe just one last one. Can you discuss if you’re seeing increasingly different trends within gene therapy and cell therapy within the broader cell and gene therapy market? Thank you so much.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Yeah. I mean, obviously, there’s a little bit of tentativeness around financing in the gene therapy space because of some of the challenges that have been seen, but that doesn’t impact the long-term opportunity. And so there’s still a lot of new startups in the gene therapy space. There’s a lot of activity and investment that’s going into the gene therapy space. But obviously, the lion’s share of funding at this point is still going into the cell therapy side of things. And obviously, with the number of potential approvals moving forward later this year, we’ve got another potential, as you already mentioned, as introductory comments and potentially another seven filings this year and potentially even another one new and two supplemental approvals this year. So there’s very strong activity in the cell therapy space as well.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Just to maybe round that off, Mark. Just would point out in our review piece, we broke down by percentages the clinical trial portfolio that we have, and the number of gene therapies in there is a single-digit percentage, and the number of vaccines is even smaller. It’s like 3%, so we’re much more exposed to the cell therapy side of the world.

Robert Stefanovich, Chief Financial Officer, Cryoport: Yeah. Correct. Thank you, Tom.

Operator: Thank you. Your next question comes from the line of David Saxon from Needham. Your line is now open.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Oh, great. Thanks for taking my questions and congrats on another strong quarter here. Maybe, Robert, I’ll start with you. I didn’t hear anything on EBITDA guidance. I think the expectation was you’d reach profitability on a quarterly basis sometime this year. So is that still the expectation? And then how should we think about profitability as it relates to 2026? Could you see that on a full-year basis, or are there any meaningful investments we should be aware of?

Robert Stefanovich, Chief Financial Officer, Cryoport: Yeah. No, thank you. As you can see from our 2025 performance to date, the improved adjusted EBITDA, we improved it by over $10 million for the first nine months, bringing our adjusted EBITDA loss in Q3 to $600,000. So we are getting very, very close to getting and crossing the line to positive adjusted EBITDA. From a cash flow perspective, cash flow from operating activities was positive for the quarter. We had about $2.2 million positive cash flow from operating activities, and we think we can get to positive EBITDA or very close to it as early as year-end. That was our target. At the same time, I do want to highlight we’re obviously trying to balance some of the growth initiatives that we have with driving towards solid positive EBITDA.

There are some specific client-driven growth initiatives that we have, including the Global Supply Chain Center that we’re opening in Paris this month, as well as the IntegriCell platform that we started out a while back, and those, in some cases, require some upfront investments. So that’s really balancing those two parts, but we’re certainly making very strong progress towards that goal, and overall, we like our momentum. We like the positioning that we’re in, and our teams are working towards executing on that goal. In terms of profitability itself and crossing the line to profitability, we have not given guidance. Our main focus is really on executing on our initiatives, driving positive EBITDA, and obviously creating that pathway to profitability.

Jerrell Shelton, Chief Executive Officer, Cryoport: David. You’ve heard us talk about the pathway to profitability before, and we certainly are on that pathway to profitability, and as Robert points out, we’re moving toward positive adjusted EBITDA. And so we think possibly we can get there in the fourth quarter and certainly early next year. And that’s a surrogate for cash flow. But remember, we have a number of facilities, which I went over in my opening comments. I just mentioned a couple of examples, a number of capital investments taking place. We know that those are the right capital investments. We vetted them thoroughly. We know that they’re the right thing to do for the future. But as we’re building those out, in today’s accounting, it does affect your income statement.

So our pathway to profitability includes all the things that Robert said, plus building out those facilities and then starting to experience the operating leverage that comes with getting those facilities up and running and utilized.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Great. That was super helpful. Thanks, Robert and Jerry, for all that color. Jerry, maybe my second one’s for you. Just on product, that growth really improved versus kind of the first half. So maybe talk about what’s driving that strength. How much of that is market versus some of those new products you called out, maybe driving some mixed benefit? And then in terms of the backlog, I guess, can you talk about that at least qualitatively? And then what level of visibility does that give you into the product growth outlook as we head into 2026? Thanks so much.

Jerrell Shelton, Chief Executive Officer, Cryoport: Yeah, you’re welcome. David, we talked about backlog a lot during the COVID period because we had an extraordinary period, but we don’t talk about backlog now as much because we are on a more normal market, which is about a six- to eight-week lead time. It’s no longer six months or a year lead time. It’s back to the normal, which is about six weeks lead time. So we do monitor our sales trends. We do monitor our order intake, and that order intake does give us indication that the market is beginning to stabilize. And of course, government shutdown hasn’t helped us there any, but it still continues to go on. It hasn’t helped us because it does slow down the government sales that are associated, but so we’re doing well in terms of the industry and the stabilization.

There was no impact on the new things that I talked about in my comments in opening up. No revenue coming in from that. It wasn’t time. It does take time for these things to get out the two doors that were developed with the integrated condition monitoring at MVE are focused on the animal health business. And so that’s a seasonal business, and there will be an uptake there. But we have a number of things going on at MVE. Does that answer your question, David? Or is there other parts to it?

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: That was super helpful. So thanks for that. I guess maybe if I could rephrase it. How the market has been stable year to date? I guess as we think about our models for 2026. Is making the assumption that that continues a fair assumption? And then with, I guess those product launches in the animal health space, maybe some increased demand across the other end markets, maybe how should we frame or how would you frame product growth potential for 2026?

Jerrell Shelton, Chief Executive Officer, Cryoport: I would look at it with stability and use a very high single-digit growth rate.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Okay. Perfect. Thanks so much, Jerry.

Operator: Thank you. Your next question comes from the line of Puneet Sood from Leerink Partners. Your line is now open.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Yeah. Hi, guys. Thanks for the question. So maybe first one on some of the cell therapy exits that we have seen. I mean, you’re delivering relatively strong growth. Some of it is comps, but some of it is just overall market stability, which you talked about. But just trying to understand if you could contrast with what we’re seeing, Takeda exiting its allogeneic programs, Galapagos is winding down their programs, Novartis is divesting its cell therapy assets. Are you seeing any downstream impact from those exits on your pipeline or the service demand overall? And then within that, as Jerry said, high single-digit growth, is that still something you’re—I mean, is that you’re contemplating into 2026 and 2027, just given sort of these exits? And maybe just provide us any context for backfilling some of these programs that might have been lost.

Jerrell Shelton, Chief Executive Officer, Cryoport: Yeah. We’re honored that you’re on the call because we thought you might miss it because of conflicts. But let me start, and then Mark will add to what I have to say. First of all, the 9%. I said high single digits, so you said 9. That’s fine, but that applies to MVE product segment, and you mix product and services. And so in the service segment where you have Galapagos, you cited, and some of the other activity that’s happening, that’s normal to me. You probably know this, but it’s normal to have puts and takes. And people make their investments, and sometimes they can support them financially going forward. Sometimes they can’t. Sometimes they’re rationalizing what they’re doing, and we have no insight on that. What we do know is we are continuing to grow. We continue to see robustness.

We have an increase in the clinical trials that we support, with 83 being in phase three. I think it was 83 in phase three. And we’re doing well, and we see a continued buoyancy in the market. This science is not going to stop. It’s going to change the way medicine is practiced around the world. It just takes time. And it has had some headwinds, but it’s buoyant, it’s strong, and we’re growing, and we intend to continue to. You want to add to that?

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: I think you answered it pretty well. The only thing I would just add is Jerry’s right. I mean, I think some of the changes that you mentioned are really strategic portfolio decisions. I don’t think they’re market-driven decisions. There’s also other companies that are putting a lot more money into and expanding their programs from a top five pharma standpoint. So. We don’t have a level of concern around that. As Jerry had mentioned, very strong pipeline activity. Very strong activity from a regulatory standpoint. As we had mentioned, upwards of another seven filings this year, upwards of potentially another 25 filings next year. So there’s a lot of activity in the space, which will continue to expand the number of commercialized therapies and the revenue associated with those therapies as the market matures.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Could I just add one more thing in there just to pile on?

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah, Tom, please.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Just to point out, September funding in biopharma was quite strong, and October was the best month of the year so far. You had over 20 IPOs and follow-on offerings of greater than $100 million in October alone. So. Some of the programs you mentioned are falling off, but certainly other ones are coming up and taking their place. But go ahead.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah, that’s about the point.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Yeah, yeah. No, thanks, Tom. On the government shutdown piece and the implied Q4 guide, I’m just trying to understand how should we think about the segments within the guide for the fourth quarter. BioLogistics versus BioStorage, BioServices versus the MVE Life Sciences product line. Maybe just help us understand. How should we think about modeling each of those if you could provide some segment commentary. And just maybe if you could pinpoint in the government shutdown exactly, I mean, what are customers telling you? What are some of the worries here if this shutdown extends into December?

Jerrell Shelton, Chief Executive Officer, Cryoport: On the first part of your question, Pune, it depends on what you think about the government shutdown. Frankly. The government shutdown is temporary. Right now, you can’t make a filing. You can’t pay your fees for a filing. But that’s going to end soon. It can’t go on forever. And there’s an election coming up, which I think will motivate a political end to the shutdown. And then we’ll see some things open up. We’ll see things start to move through, and we’ll catch up. So. I don’t. It’s not going to last forever. The government shutdown isn’t. And again, under the backdrop we’ve had, we’ve shown substantial growth in spite of any headwinds there. Mark, do you have anything to add to that?

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah, I think you answered it well. I mean, yeah, on a service standpoint, we haven’t seen any impact other than the delay in filing activity, which they just can’t do because they can’t pay the, as Jerrell mentioned, they’re filing their application fees. That’s the only impact that we’ve seen is there may be a short-term delay in some of the filing activity. But the service activity still remains very robust.

Jerrell Shelton, Chief Executive Officer, Cryoport: Yeah. And then just looking at Q4 without going into too much detail, obviously, we expect year-over-year increase on the services side. On the product side, it largely depends on timing, especially if you look at some of the larger freezer orders or even some of the potential delays in government shutdown. That could just have an impact on timing of whether those are going to come in Q4 or be shifted in Q1. That’s because they’re capital expenditures, and somebody has to sign off on them.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: All right. Thank you, guys. Appreciate it.

Jerrell Shelton, Chief Executive Officer, Cryoport: Does that help? Does that answer?

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Yeah. Thank you.

Jerrell Shelton, Chief Executive Officer, Cryoport: Thank you.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Thank you.

Jerrell Shelton, Chief Executive Officer, Cryoport: Yes, it did.

Operator: Thank you. Your next question comes from the line of Matt Stanton from Jefferies. Your line is now open.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Hey, thanks. Maybe one for Mark. Just on the commercial trends, you’re tracking up over 30% here year to date. Sounds like you saw some improvements here early in the quarter, continue more filings, and then I think next year 25%, which is a big number. Can you just talk about the durability of the growth in terms of what you’ve seen here from customers? And as we think about that kind of 30% plus, how you feel about that on the commercial side into 2026? And I mean, is there opportunity for that to accelerate even further if some of these things kick in on REMS or some of these filings kick in and, to your point earlier, start to get signed off and get out there? But just talk about the kind of growth algorithm on the commercial side. Thanks.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. I think as you focus, you got to focus on two things. One is the existing therapies as they mature, they move to earlier line, and they go through global expansion. And as we had mentioned earlier, I mean, both BMS and Janssen and J&J have come out with very positive comments around growth. And their data, their financial data supports that. Janssen said their goal is 10,000 doses by year-end and 20,000 patients by the end of 2027, which is a substantial increase. And then you have the newer therapies as they launch. They’re also expecting significant ramps. Vertex has come out and said they expect to see Casgevy start to ramp more. Significantly. And then we have other data on some of these earlier launches, which most of it has come out. Or ahead of guidance.

So if you take those in addition to the new filing activity, we think it’ll remain robust in 2026 and beyond.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: All right. Great. Thanks. And then, Robert, maybe just to go back - I know it’s been brought up a few times - just on the Q4 ramp. I mean, I know last quarter, you guys were kind of saying Q4 probably higher than Q3, part of that seasonality. Obviously, Q3 came in better than we expected. Is it fair to say that the sequential quarter-over-quarter implied Q4? I mean, the government shutdown, maybe some of the timing you talked about. I mean, is that kind of a low single-digit million impact tied to those and maybe erring on the side of conservatism? Just kind of thinking about three months ago, Q4 higher than Q3, and now we have kind of the opposite playing out. And maybe just confirming there was nothing kind of that fell in Q3 that you had previously expected to fall in Q4. Thanks.

Jerrell Shelton, Chief Executive Officer, Cryoport: No, there’s not. But you already really framed it. I think it’s really balancing that and looking at our guidance. Certainly, we have upside potential, no question. But given some of the uncertainties, we felt that that guidance kind of reflects where we stand right now to acknowledge some of those other aspects that we discussed earlier.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Super. Thank you.

Operator: Thank you. Your next question comes from the line of Suvranil Sinha from Guggenheim. Your line is now open.

Robert Stefanovich, Chief Financial Officer, Cryoport: Hey, guys. Thank you for taking my question. You recently announced the Tripod Systems received ISO certification. Could you speak to what this means in terms of your customer win rate or any competitive dynamics? How meaningful is this?

Jerrell Shelton, Chief Executive Officer, Cryoport: I want Mark to speak to that. But in addition to that ISO, we’ve also won an award or two, and certainly one that we’re proud of. We did help on that ISO. So Mark, take it away.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. So ISO 21973, which is really around the governing of handling of cell therapy-based materials, is what we received that certification in. We are the first entity that has received a formal ISO certification. Others have claimed that they have compliant with it, but we actually have received the certification from the ISO governing body related to that. Yeah, on a global basis. So what it really does is it reinforces us as the best in class and the gold standard as it relates to the management of these therapies on a global basis and reinforces, obviously, the quality paradigm that we have.

And I think as you look at our growth as it relates to commercial revenue as well as our clinical trial adds, the market continues to respond very favorably to that as they continue to put a larger share of the overall clinical trial count as well as the commercial activity into our portfolio. So we believe that’ll be a continued positive influence on decision-making by our clients and sponsors.

Jerrell Shelton, Chief Executive Officer, Cryoport: You might mention that award that we won also, Mark.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. Yeah. We actually won two awards, a CPHI award, which is one of the larger chemical industry awards for excellence of temperature control supply chain solutions. And then we also won another one from a biotech agency, which also reinforces that in the quarter. So I think the markets are absolutely responding to our platform as best in class.

Robert Stefanovich, Chief Financial Officer, Cryoport: That’s great. Thank you for that. Any updates you can share on how you’re progressing with your China first strategy? What milestones can we expect as we look to growth in that region for you guys?

Jerrell Shelton, Chief Executive Officer, Cryoport: We have not assumed any growth in China. We will not be assuming any growth in 2026. There’s no change right now. We do have some efforts underway. It does take time to implement strategies of that nature, and we hope by 2027, it’ll be certainly one thing we cannot ignore China. It is an advanced country. It has a very high population, a very big population, and it has resources, and it can move very quickly, so we will continue to work on our China strategies, but we don’t have anything we can report further right now.

Robert Stefanovich, Chief Financial Officer, Cryoport: Perfect. And a last one for me. Is there a potential for a catch-up heading into 2026, just given the environment is improving, something that you touched on previously?

Jerrell Shelton, Chief Executive Officer, Cryoport: You’re talking about a catch-up in terms of. What are you talking about, Suvu, in terms of catch-up?

Robert Stefanovich, Chief Financial Officer, Cryoport: So. Catch-up as in ordering. Do you anticipate that could be some sort of catch-up orders next year?

Jerrell Shelton, Chief Executive Officer, Cryoport: So I think.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: I think she’s referring to the product side, guys.

Jerrell Shelton, Chief Executive Officer, Cryoport: Yeah. Yeah. When you talk about the products, I think what we said is it’s really stabilizing. I don’t think we can speak of that at this point in time. I mean, in general, conceptually, obviously, more and more material is being developed that requires cryogenic storage, and MVE being the largest global provider of storage and cryogenic systems, certainly, we will be the first beneficiary of that, but at this point, it’s just stabilization of the market that we can see.

Robert Stefanovich, Chief Financial Officer, Cryoport: Perfect. Thank you so much, guys.

Operator: Thank you. Your next question comes from the line of David Larsen from BTIG. Your line is now open.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Hi. Congratulations on another very good quarter. It looks like the number of clinical trials, the growth rate year over year was the highest. It’s been in like two and a half years. And just any thoughts on the big, beautiful bill act, reductions in Medicaid enrollment, reductions in exchange enrollment, maybe as high as 10% or 30%? Does that matter or not? Any thoughts on payer mix? Are most people getting cell and gene therapies? Are they covered by commercial plans, not Medicaid and exchanges? Just any thoughts that would be helpful.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. I personally don’t think it’s much impact at all. The vast majority of therapies, by my understanding, are not being covered by public funds. They’re traditionally or typically private plans that are reimbursing at this point.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Okay. And then do you have any concerns around drug pricing, like with price caps due to the Inflation Reduction Act or rebate flow, limits on price increases? Has that entered into any conversations at all or not?

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: No. Not on our.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: Therapies are exempt from all of that, Dave?

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. Yeah. I was going to say the same thing. I said, yeah, I mean, the White House has actually come out in support of cell and gene, and they’re interested in continuing to support it in an aggressive manner. And they are exempt from some of the pricing constraints that the White House is currently working through.

Various Analysts, Analysts, UBS, Needham, Leerink Partners, Jefferies, Guggenheim, BTIG, Stifel: They’re also not impacted by any tariff talk either.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Okay. Great. So minimal regulatory risk heading into 2026. Fantastic. And then in quarters past, you’d talked about the growth in number of clients at these BioStorage facilities, I think, in New Jersey and also Allendale storage. Any color there in terms of capacity or number of client growth?

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. I mean, we’re still continuing to onboard a significant number of clients at those sites, both existing and new clients. And so that rate continues to be very robust, as evidenced by the sales data that we put forth. Publicly. So we anticipate continued growth in the bioservices area into 2026. Based on that.

Jerrell Shelton, Chief Executive Officer, Cryoport: By the way, Dave, this is not a singular thing. This is not a singular strand. I mean. We built these on a strategic basis. We built them to support our clients and to create more of a one-stop shop because clients actually prefer doing business with less vendors, and especially one that they can trust. So it’s kicking in. And our clients are beginning to take hold of our bioservices operations within Cryoport Systems.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. We’re averaging almost two audits a week at this point. So that’s obviously a significant volume of new workflow that’s coming into the facility.

Jerrell Shelton, Chief Executive Officer, Cryoport: So you’re witnessing a strategy play out right now.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Great. One more quick one. IntegriCell, I get questions on that all the time. Just any more color there would be helpful. It sounds like you’re building a new facility. Is that going to support global efforts for IntegriCell? And do you have revenue coming in for that business yet or not? Just any more color would be helpful.

Jerrell Shelton, Chief Executive Officer, Cryoport: Let me start, and Mark can give you more detail. But IntegriCell is another strategic endeavor, and we do have a network in mind, but we are carefully going into the development of IntegriCell. As Mark said earlier, we have revenue coming in at both locations. But I want to see those locations closer to cash flow, to positive cash flow before we add other operations. We do have plans for other operations. They will be added. The network will work. All the information that we’ve gotten so far is very encouraging. And now we’re on the uptick by getting customers, clients, and revenue coming through those two facilities. And I’ll just turn it to Mark after that.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Yeah. Yeah. As Jerry said, it’s exactly right. We opened those facilities at the end of Q3 last year. And the tech transfer process takes time because it’s part of the production process. So there’s regulatory activity that needs to occur for adoption. But we have completed our first tech transfers from both biotech and top 10 pharma. And we have started to generate revenue from both sites, both the site in Belgium as well as the site in Houston, Texas. And our expectation is that revenue will ramp modestly in 2026 with a significant ramp, almost in a hockey stick modality, post 2026.

Dr. Mark Sawicki, Chief Scientific Officer, Cryoport: Great. Congrats on a good quarter. Hop back in the queue.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Thank you.

Jerrell Shelton, Chief Executive Officer, Cryoport: Thanks, Dave.

Operator: Thank you. Your next question comes from the line of Mark Hittle from Stifel. Your line is now open.

Hey, guys. Thanks for taking my questions. Robert, maybe just a quick one on margins. Just as this new facility comes online, can you just walk us through how these startup costs and the ramp in timing have been factored into your model and just how you expect that to influence margins over the next few quarters? Thanks.

Jerrell Shelton, Chief Executive Officer, Cryoport: No, it’s a very good question. And it’s, again, one of those balancing acts because you’re absolutely right. We have new facilities going online. IntegriCell went online, as Mark mentioned. We have a global supply chain center in Paris by the Charles de Gaulle Airport going online, with the official opening being in a few weeks from now. At the same time, we are seeing some operating leverage already of the existing facilities, and that allowed us to show gross margins reaching 48% and even higher on the service side in particular. We do typically have startup costs that we run the SG&A, but then as we open the facilities, you’ll see some impact on the margins.

So while we see operating leverages in some of the existing facilities, they’re driving higher margins, you’ll have some margin depression by these new facilities coming online and starting to see revenue ramp over time. So as we start and really, 2026, 2027 is really about that operating leverage, really about driving utilization of the existing global footprint that we have that will ultimately drive the gross margins. Our target is 55% gross margins overall and a 30% EBITDA margin. And obviously, there’s still some time to go to get to the gross margins, but we’ll see that operating leverage kick in later in 2026.

Appreciate that. And just touching on those long-term margins. Can you just highlight your thinking in terms of timing around those as well? I know it’s been a longer-dated proposition. I just kind of want to get your updated thoughts there.

Yeah. We’re not giving guidance on that at this point in time because it’s really, if you look at the cell and gene therapies market, it is still a fairly new market when it comes to actually the commercialization of therapies. So we want to see more progression and more therapies come to market. But we’re clearly on that pathway, as you can see, in terms of the significant improvements to adjusted EBITDA as a first indicator. And we’ll certainly drive that further into 2026 and 2027.

I appreciate the context. I’ll leave it there.

Thank you.

Todd Fromer, KCSA Strategic Communications, KCSA Strategic Communications: Thank you.

Operator: Thank you. There are no further questions at this time. Turning over back to Jerrell Shelton. Your line.

Jerrell Shelton, Chief Executive Officer, Cryoport: Well, thank you very much. And thank you for your questions and our discussions. In closing, in the third quarter, we continued to see strong momentum in our business. This included double-digit revenue growth in both our core business segments. Our Life Sciences Services segment, the key driver of our future growth, grew 16% year over year, driven by a 21% increase in Biostorage bioservices revenue and a 36% increase in commercial cell and gene therapy support. We also continued to see further steadiness in our Life Sciences Products business, where revenue grew 15% for the quarter. Cryoport is positioned as the critical temperature control supply chain company supporting the life sciences that de-risk the end-to-end delivery of cell and gene therapies worldwide. Thank you for joining us today.

We appreciate your continued support and interest in our company and look forward to speaking with you again when we report our fourth quarter and our full-year financial results.

Operator: Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.