8/5/2025

speaker
Operator
Conference Call Operator

we will conduct a question and answer session. If at any time during this call, you require immediate assistance, please press star zero for an 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.

speaker
Todd Fromer
Host, 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 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 10K to be filed with the Securities and Games Commission and those described from time to time in the other reports which we filed with the Securities and Exchange Commission. As a reminder, Cryoport has uploaded their second quarter 2025 in review document to the main page of the Cryoport website. These documents provide 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, CryoPDP's financials, which were previously a part of Cryoport's life sciences services reportable segment are now presented as discontinued operations. Cryoport previously provides quarterly historical information on this basis for fiscal year 2024 in our first quarter 2025 review document which remains available on the Cryoport 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 guidance. It is now my pleasure to turn the call over to Mr. Gerald Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Thank you, Todd. Good afternoon, everyone. With us this afternoon is our Chief Financial Officer, Robert Stavanovic, our Chief Scientific Officer, Dr. Mark Sawicki, and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. Today, Cryoport reported strong double-digit revenue growth across all revenue streams in our life sciences services for the second quarter. Service revenue increased 21% year over year, accounting for 54% of total revenue from continuing operations. Notably, revenue from our support of commercial cell and gene therapies increased by 33%, and bio storage, bio services grew 28%, underscoring the growing demand for our integrated temperature control supply chain platform. This growth continues to be fueled by the increasing adoption and scaling of cell and gene therapies, a positive trend we believe will continue for years to come. Turning to our life sciences products, we posted a solid performance with 8% year over year revenue growth driven by improved demand, particularly from animal health customers during the quarter. We also continued to expand our product portfolio with the launch of our next generation MVE SC42V and SC43V vapor shippers, which offer medical and animal health professionals improved safety and reliability for transporting and preserving sensitive biological materials at cryogenic temperatures. During the second quarter, we also recorded revenue in accordance with plan from sales of MVEs high efficiency 800C cryogenic storage system, which was released earlier this year. This compact form factor freezer was designed for facilities with limited space that require high capacity and security. These innovations demonstrate our continued commitment to addressing the evolving needs of our clients globally and expanding our future revenue potential. For the second quarter, we had an overall 14% increase in total revenue from operations, and we delivered an increase in gross margin along with a meaningful lift in our adjusted EBITDA as a result of our pathway to profitability initiative. Given the strong execution across all our business units, we are reaffirming our full year 2025 revenue guidance as we move toward our goal of sustainable long-term profitability, which will accelerate as our capital projects mature. I'm pleased with all the progress of all of our business units, but I would be remiss if I didn't highlight one of the most significant achievements for the second quarter, which was our launch of our strategic partnership agreement with the DHL Group and DHL's acquisition of CryoPDP in a transaction that included cash payments of approximately $200 million to cryoport. Aside from a strong infusion of capital, this strategic partnership provides for enhancing our global biologics capabilities, biologistics capabilities and effectiveness by leveraging DHL's competencies, scale and reach in Asia-Pac and EMEA, we will be increasingly well positioned to expand our life sciences business and deepen our leadership in the rapidly growing global regenerative medicine market. This strategic partnership is an initial step as we continue to work to develop a strong global partner network that complements our core capabilities through discussions with various global companies. Before we take your questions, I want to briefly address a unique situation with one of our clients that has received some immediate attention. One of our gene therapy clients temporarily paused the distribution of their commercial therapy for about a week in July. The therapy is now back on the market and shipping to patients. However, that company anticipates treating fewer patients than originally forecast in 2025. We do not expect this to have a material impact on our business. Our guidance that we reaffirm today considers an estimated revenue impact of approximately $2 million from this client for the remainder of the year. As of June 30th, CrowdFort supported a record 728 clinical trials, which is approximately 70% of the industry cell and gene therapy trials. For the remainder of 2025, we anticipate up to an additional 20 application filings, one new therapy approval, and an additional three approvals for label or geographic expansion. Also, we want to note that during the quarter, five of our clients that had filed for approval earlier this year or late last year received negative opinions from the FDA or MAA. All these clients have requested meetings with the regulators to find a pathway forward to bring their therapies to market. Given the need for these therapies, along with the recent changes within the FDA, many analysts are thinking more positively about their chances of gaining approval later this year or early in 2026. The strength and resilience of CrowdFort's performance in the second quarter, despite these challenges, faced by a few of our clients, by largely in the broad number of clinical trials we support and the scaling of the current commercial therapies we are supporting on a global basis. Our commercial revenue is expected to drive our growth for years as it is boosted by additional CrowdFort supported therapies as they reach commercialization, including the new cell therapy from our customer, Aviano, Aviana Therapeutics, that was approved by the FDA during the second quarter. I probably mispronounced that, I think it's Aviano not. In summary, our second quarter was marked by strong revenue growth, improved margins, and the beginning of the execution of a transformative strategic partnership agreement. We are entering the second half of the year with strong momentum and a clear focus on driving long-term shareholder value as we support the growth of the global regenerative medicine markets and the life sciences in general. As the regenerative medicine industry accelerates, the complexity and precision required to safely deliver personalized, often life-saving therapies has never been greater. Our global platform of temperature control supply chain solutions coupled with real-time informatics and regulatory compliant processes enable 728 active clinical trials and 18 commercial therapies worldwide. Whether supporting first in human studies or globally scaled commercial treatments, CrowdFort ensures -to-end integrity from the manufacturer, from the laboratory to the manufacturer to the points of care to the patient's bedside, our advanced packaging systems, bio storage and bio services capabilities, biologistics and cryogenic infrastructure have become mission critical to the industry's leading biopharma companies, CDMOs and researchers alike. In short, we form the connective tissue between researchers, manufacturers, and the patients enabling the secure preservation and movement of living regenerative therapies with real-time data and systems and a global reach. We do more than support the life sciences ecosystem. We make it responsive, resilient, and ready for the future of medicine. This concludes my prepared remarks. So now I'll ask the operator to open the lines for your questions.

speaker
Operator
Conference Call Operator

Thank you so much, ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press star followed by one on your touchtone phone. You'll hear a prompt that your hand has been raised. Should you wish to remove your hand from the queue, please press star followed by two. If you're using a speakerphone, please lift the handset before pressing any keys. Just a moment for your first question. And your first question comes from Kyle Cruz with UBS. Please go ahead.

speaker
Kyle Cruz
Analyst, UBS

Thank you for taking our questions. Could you please provide a brief update on the non-cell gene therapy demand that appears to be driving the product revenues in the quarter? And could you provide an update on Integra Cell and how the adoption there is going? Thank you.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

I think both those questions can be answered by Dr. Czkiewicki.

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

Yeah, so, you know, Integra Cell continues to progress nicely. You know, we are moving forward with, I'm sorry, just give me one second here. Sorry, can you repeat the first part of the question?

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

The first part was on MVE, maybe I'll step in. I'll read through that for you. MVE, we are feeling better than we were about six to 12 months ago. The revenue there did improve up 8%. We do continue to believe that the business stabilized in the quarter and in last quarter. Globally, markets have been disrupted by governmental policies, and we do expect the uncertainty to continue to impact capital spending, as you could see with other life science companies. In particular, at MVE, they had a very nice quarter from the animal health side with cryogenic system sales. Go ahead, Mark, on Integra Cell. I apologize

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

for the mix-up. Yeah, so Integra Cell is proceeding on track. We do anticipate the initiation of revenue production this quarter, with meaningful revenue starting in 2026. We are actively tech transferring in our first clients right now, which takes a little bit of time, but that's gonna start to help support revenue contribution later this year and into next year.

speaker
Kyle Cruz
Analyst, UBS

Great, and then maybe as a follow-up there, you maintained the guidance, but you had a really great quarter, and it seems like the market seems to have improved, and there is upcoming revenue streams into 2H. Can you go through the phasing on your 2H guidance, and maybe go over why you didn't increase the guidance? Thank you.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Yeah, we didn't increase the guidance, because we're being prudent, of course, given the uncertainties in the global economy and geopolitical uncertainties, as well as administrative uncertainties, and looking at the market and the puts and takes and so forth, we felt it was more prudent to keep our guidance where it is, and so that's why we reaffirmed it the way it is.

speaker
David

Great, thank you very much.

speaker
Operator
Conference Call Operator

Your next question comes from David Saxon with Needham. Please go ahead.

speaker
David Saxon
Analyst, Needham

Oh, great. Thanks for taking my questions, and congrats on the quarter. Maybe just a follow-up to that last question on guidance. Just, you know, comps, I guess, you know, third quarter, it looks to be an easier comp, and then, you know, easy comp, but slightly harder, and then the fourth quarter, so how should we think about growth exiting the year, and any early thoughts on 2026, just given, you know, the momentum you're seeing, and then all of the follow-ups?

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

Yeah, just on 2026, obviously on 2026, we'll give guidance, typically at year end. You know, we are providing some outlook in our review, please, that's posted on our website, related to the expectations on VLA and MA filings, and approvals, so I'd encourage you to look at that document as well. I think you're looking at the second half of the year, as Jerry mentioned, you know, where we're holding to our guidance for the full year. There's certainly upside opportunity there, but typically, we would expect, obviously, a stronger Q4 compared to the Q3 revenue growth. I think overall, in terms of the general performance of the first half of the year and the second quarter, you know, actually, we made significant improvements in terms of gross margins, both on products and services, bringing total gross margins to 47%, so that's a significant increase over a prior year, and then from a bottom-line perspective as well, if you look at the adjusted EBITDA from continuing operations where, for Q2, at a negative 0.9 million, from a negative 5.6 million in the prior year, or a negative 2.8 million in Q1 of this year. So, you know, everything's moving in the right direction, revenue growth, gross margins, as well as the bottom line, and we certainly wanna push that forward during the second half as well, so that's, I think, as much as we can say at this point.

speaker
David Saxon
Analyst, Needham

Okay, great, no, that was super helpful, thanks for that, and then, I guess, just on the balance sheet, I mean, 426 million in cash post the sale of PDP, looks like you did some smaller share of purchases over the last couple of months, but would love just an update on how you're thinking about capital allocation philosophy. You've done M&A in the past, you took a pause there, so, you know, would love your updated thoughts there. Thanks so much.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Yeah, David, we did buy back some common stock in the second quarter, and we'll continue to take our usual prudent approach to deploying capital. We'll be thoughtful, opportunistic, and we'll also be strategic with all the funds that we have, but we'll continue to consider buying back our stock because we think it's significantly undervalued in the market.

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

Just to put a number on it, we did buy back a million shares since our last report.

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

Yeah, and Jeremy, just to add, you know, obviously cash is king in this environment. We did pay back, you know, the 2025 convertible notes, about 14 million during the second quarter, and we obviously will want to maintain a strong balance sheet while evaluating the various options that we have to apply our capital, our cash.

speaker
David Saxon
Analyst, Needham

Okay, and if I could just, I guess, follow up on that. So, any change in your appetite for M&A, or you just want to kind of protect the balance sheet, and maybe do some opportunistic share purchases? Is that

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

the message? You know, David, we'll be opportunistic, and if an acquisition comes along that's compelling, it's accretive, it meets our profile, we'll certainly consider it, but you know, our focus right now is internal. We have initiatives going on that we need to execute on, and so we're constantly getting opportunities presented to us. We look at them, and if they're compelling, we will definitely consider them, but there's no plan for any acquisitions at this point.

speaker
David

Okay, that's helpful, thanks, Jay.

speaker
Operator
Conference Call Operator

Your next question comes from Matt Stanton with Jeffreys. Please go ahead.

speaker
Matt Stanton
Analyst, Jefferies

Hey, thanks. Wanted to kind of zoom out for a higher level question out, move for Jerry. Just in terms of the late quarter FDA update on the REMS and certain indications of approved CAR-Ts, what's the early feedback that you've heard from customers, and is there any way to kind of talk about the impact or potential impact this could do, you know, due to patient volumes and any more color on timing as it relates to that update that we got late in the quarter? Thank you.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Hey, Matt, the impact of the ruling on REMS is very positive, and everyone sees it as positive. It's really too early to quantify exactly what that means, but we do think it'll make it much easier for everyone in the system, and it'll certainly make it easier for rural points of care and so forth. And Mark may want to add to that?

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

No, I mean, Jerry's absolutely correct. It should have a definitively beneficial impact, and some of our key clients have already reported on it in a positive way, and others are still to report. We would expect to see updated forecasts from our clients and any impact on that during the third quarter. So we should have more clarity at the next earnings call.

speaker
Matt Stanton
Analyst, Jefferies

Great, thanks. And then maybe just on BioFarm, I think for the product side, you talked more about animal health, but just, you know, in terms of your BioFarm, our customers either buy product or region, you know, pretty robust trends in the quarter. What are you hearing from customers in terms of appetite to spend, how that might vary? You know, we've seen kind of mixed signals from CROs and spend on certain projects, you know, capital-related projects maybe being pulled back, given the macro, but would just love some updated color in terms of your discussions with your BioFarm or customers globally, thanks.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Certainly, there's enough capacity for manufacturing in the industry right now, and I think that, you know, Mark might want to comment on that further.

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

Yeah, so you've got to take a look at where the pullback is occurring. The vast majority of the pullback is really directed through the NIH and ties into really preclinical and late preclinical activity. So R&D and preclinical, you know, our focus is really on the clinical commercial space, and the vast majority of our clients are well-funded and have significant relationships with, you know, large pharmacies and others, so we don't anticipate it, and a negative impact from that perspective. And in fact, obviously, you know, I think that the demonstration of the continued increase in acceleration of the clinical trials supported, up to 728 in an increase of 40-40 year over year, an increase in phase three trials, you know, demonstrates the continued support of that portfolio, which will have significant benefit for us over time.

speaker
Matt Stanton
Analyst, Jefferies

Thanks, and maybe just one more, if I could see again. Just, Robert, on gross margins in the back half of the year, obviously, the implied guide has revenues kind of coming down a bit from 2Q levels. First half saw a lot of good progress on gross margins. Should we expect gross margins to step down modestly in the back half of the year from kind of that 46% in the first half, or do you think that's kind of a sustainable level going forward, just given the number of issues and the progress there? I think we're certainly

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

gonna try to sustain it during the second and a half. You know, typically, we'd expect gross margins to increase further just due to operating leverage, but we do have some newer initiatives, as you're aware, you know, like Integra Cell and building out some of the facilities in Paris and Belgium, and ultimately California. So that will have some impact on gross margins as they start ramping up. So I would look at, you know, for modeling purposes to keep it relatively flat.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

It'd be a temporary impact.

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

Now, our stated goal, you know, based on reaching operating leverage is really to get to gross margins in excess of 55% with adjusted even margins of 30%.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

And we think that's how you achieve a goal, that

speaker
David

over time, it just takes a little time.

speaker
Operator
Conference Call Operator

Your next question comes from Paul Knight with KeyBank. Please go ahead.

speaker
Paul Knight
Analyst, KeyBank

Hi, Mark. As you've seen this commercial market accelerate, what are you seeing in terms of competitive dynamics? Are there major players trying to be there? Are some customers wanting to homebrew? What are you seeing or learning as the commercial side grows faster?

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

You know, to be honest, we're seeing more and more of folks that really want the security supply and the scalability that we offer. You know, we're supporting the vast majority of the commercial space today, and we're actually engaged in discussion around expansion, of what we're doing beyond traditional biologistics into our other service areas. That's why you see the nice step up in our bio services revenue. And we're also very active on integration. So most of the bigger players that you may be referring to actually wanna work with us, not against us. They want us to be a component of their offering because of the strength that we have in the space. And, you know, the DHL deal that Jerry talked about is an example of that, but you'll see more of those types of announcements in the coming months and quarters as other larger players in the space want to work with us collaboratively, not competitively.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Yeah, and you shouldn't underestimate the power of that integration, Paul. The integrated solution is what is being sought out more and more. Our clients want to simplify their efforts. I mean, and so our integrated temperature control supply chain solutions are picking up steam.

speaker
Paul Knight
Analyst, KeyBank

And Jerry, on MVE, do you feel like in the biopharmaceutical market that, you know, I guess it was de-stocking post-COVID, do you think that starting to be bottoming a disjuncture?

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Well, my thinking is that most of that excess capacity that was built up during COVID has been burned off and that the market is stabilizing. We've had three good quarters at MVE with a solid 8% growth this past quarter. And so I think it's returning to normalcy.

speaker
Paul Knight
Analyst, KeyBank

And then lastly, Robert, I guess we should expect some continuing EBITDA margin expansion because I'm assuming you have a lot of your infrastructure built in except for Integra cells. So, you know, the top line should drive natural EBITDA progression. Is that kind of the logic?

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

I think you're right. I mean, it will depend on the top line growth in terms of the EBITDA achievement in Q3 and Q4. We do have a couple of initiatives, Integra cell being one of them. And with that also the buildup of our facilities, you know, in Paris and some further build out of capabilities in Belgium. So there will be some additional headcount and expenses that we'd expect to ramp in, you know, later in the second half. But in general, yes, we're certainly driving towards, you know, profitable revenue and

speaker
David

positive EBITDA. Thank you.

speaker
Operator
Conference Call Operator

Your next question comes from David Larson with BTIG. Please go ahead.

speaker
Jenny
Analyst (on behalf of David Larson, BTIG)

Hi, this is Jenny on for Dave. Thanks for taking the question. I apologize if you already spoke about this in the beginning of the call. I'm juggling a couple of calls here, but can you just talk about your updated view on tariffs, your expectation for costs, whether you're passing along full costs or partial costs, the customers and what their appetite to accept those higher costs has been. Thanks.

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

We've seen really no real impact on tariffs across the business. You know, any tariffs that we do have an impact on our business, we would absolutely pass through. And we have a precedent for that through, you know, historical COVID, which with our clients are well aware of. So if there is any impact from a tariff standpoint, it would be passive, but we haven't seen anything material to date.

speaker
Jenny
Analyst (on behalf of David Larson, BTIG)

Thank you.

speaker
Operator
Conference Call Operator

Your next question comes from Subu Nambi with Guggenheim Securities. Please go ahead.

speaker
Thomas
Analyst (on behalf of Subu Nambi, Guggenheim Securities)

Hey guys, this is Thomas on for Subu. Thanks for taking our questions. I just want to touch on the guide again. Can you just talk about where the offset is to that headwind from lower surrupted revenue and the reiterated guide? That's a stronger performance across the portfolio?

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

I think, yeah, in general, it's just, you know, a stronger portfolio. You can see we had increases, obviously in commercial revenue, we had increases in clinical trial revenue and in clinical trial count. So we've really seen increases across the board in our services lines, as well as in the product lines.

speaker
Thomas
Analyst (on behalf of Subu Nambi, Guggenheim Securities)

Okay. And then how much of the second half guide for revenue depends on pharma, clinical, and commercial milestones that may be out of your control? Or is that largely due risk at this point?

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

Any, just to remind you, any new approvals that would happen here recently take a while to ramp. So that isn't really a part of or a factor in our guide.

speaker
Thomas
Analyst (on behalf of Subu Nambi, Guggenheim Securities)

Okay. Okay. And then if I could just sneak one more in on China here, any updates you can share on how you're progressing there and any milestones you can point us to as we look for growth in that region for you guys. Thank you.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

We're not expecting our market to expand in China, or any recovery in 2025, and that's reflected in our guidance. You know, we continue to monitor our customers there and the various domestic government stimulus programs, but nothing really has changed that much.

speaker
Operator
Conference Call Operator

Our next question comes from Mac Etoch with Stevens, Inc. Please go ahead.

speaker
Mac Etoch
Analyst, Stephens Inc.

Good afternoon. Now that the DHL transaction is closed, can you comment on how your customers are responding to Cryoport becoming a little bit more carrier agnostic and just what has the feedback been thus far?

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

Overall, it's been extremely positive. You know, folks are excited to see what the, you know, the lift benefit from DHL will be as it relates to obviously logistics solutions and flexibility. It also obviously provides them the ability to continue to work with their carriers of choice and to weave in, you know, DHL competencies on a complementary basis. So overall, I think very, very positive.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Matt, this is just beginning. We just began the launch, and DHL is a huge company, you know, approaching $100 billion in revenue. And so it takes a little while to get these things into place. So this is not, you know, it's not like, it's not instant. It does take a little while to get them in place, but Mark is correct about, you know, the direction.

speaker
Mac Etoch
Analyst, Stephens Inc.

I appreciate that. And just following up on Integra, so obviously that's a little margin dilutive at the moment as you ramp, but I was kind of curious if you could give some, you know, qualitative aspects of what you expect the long-term margin profile for that.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

I'll turn it over to Mark, but in just a second, but I, IntegraCell, you know, is just ramping up, and it's a revolutionary service. I mean, the way we've put it together, the Cryopreservation Service, and we're doing some tech transfers right now in both Houston and in Belgium. And so we expect some revenue in the fourth, in third, fourth quarter, late third quarter, maybe fourth quarter of this year, and then more significant revenue, of course, in 2026. So it's coming along on schedule and development. We're very enthusiastic about it. It does have a very good financial profile for the future, and I'll let Mark talk about that.

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

Yeah, as Jerry had mentioned, you know, we've historically discussed gross margins in the 60% range at maturity for our service business, and we expect the IntegraCell business at maturity to be in line with that expectation.

speaker
David

Thank you for taking my questions.

speaker
spk00

Your next question.

speaker
Operator
Conference Call Operator

Oh, I believe he was just thanking us. Your next question comes from Punit Suda with Learing Partners. Please go ahead.

speaker
Punit Suda
Analyst, Learing Partners

Yeah, hi guys. Thanks for the questions here. So first one, just wanted to confirm, those two million had been for annual for Sarepta. Were you baking in anything for 2026 there, and are you seeing any signs of broader caution or delays among the, you know, AAV gene therapy programs or clients? You talked about, you know, five of them, you know, that you're supporting. They received negative opinion by FTA. I just wanted to make sure if that's, those two issues are tied together.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

I'll turn the technical side, the gene side over to Mark in just a moment, but Punit, we haven't baked anything into 2026. We haven't commented on 2026, and we will, but we will, you know, later on in the year after our budgeting and so forth takes place. But so we'll reserve that one, but in terms of the other part to your question, Mark, do you want to answer that part?

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

Yeah, you know, I view this really as just a, you know, you had a change in administration, you know, you had a change at the FDA, which, you know, obviously they had to get in and get their feet wet, so to speak. And, you know, I think that, you know, some of the data that you've seen is them just really trying to get an understanding of the space a bit and, you know, taking a little bit more caution around the data side of some of these, you know, these filings. You know, so you have that as obviously a little bit of caution, you know, but you also see very positive responses from the FDA as it relates to things like RENs. So I think that, you know, on a whole, we don't see any material impact to, you know, what we expected historically around the market opportunity associated with cell and gene commercialization. I'm not sure if, Tom, you want to add anything to that or not? Just,

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

Panit, to, I think, maybe clarify one. The 2 million headwind from Sarepta is for the second half of the year only, not for the full year.

speaker
Punit Suda
Analyst, Learing Partners

Right. Got it. Okay. Thanks for that. And then on MVE, could you clarify which end of market where you saw the most growth? Was it the animal side? Is it the pharma? Maybe just walk us through, you know, which business line actually drove MVE growth for you?

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

Sure, I'll take that, Panit. Or was it the distributor

speaker
Punit Suda
Analyst, Learing Partners

channel?

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

Well, it was a solid second quarter, but it was really overall balanced demand. The animal health market was particularly strong on the doer side. They had a record amount of doers sold on the animal health side, but it was also solid for cryogenic system sales in the APAC outside of China and in EMEA.

speaker
Punit Suda
Analyst, Learing Partners

So majority of the growth was in APAC. Just wanted to clarify it, because we're constantly hearing about capital equipment challenges, so I wanted to square that and make sure I understand correctly where the MVE growth is coming from.

speaker
Thomas Heinzen
Vice President, Corporate Development and Investor Relations, Cryoport

So it's APAC outside of China, EMEA. North America was okay. It wasn't, you know, a record or anything like that. And then on the doer side, it was balanced across animal health companies across the globe.

speaker
Punit Suda
Analyst, Learing Partners

Got it, okay. And then maybe just last one for me. With you highlighted DHL, but just wondering, you know, are you seeing any change in the competitive landscape overall? You know, you have a number of other logistics companies that have been looking at these markets. Just wanted to get a sense of if you're seeing any change in the competitor dynamics or the market share for clinical trials.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

Nothing significant. Everything we see is positive and we do have a distribution strategy. The first part of that was DHL. We're talking about the global companies in addition to what we already have. And actually we can support most of those companies that you were talking about, so are referring to. So nothing significant there to talk about other than it's positive.

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

Yeah, and as you can see from the data, you know, we're continuing to increase the number of clinical trials we support. We're continuing to fortify our leadership position by the expanded solutions. You can see the bio storage, bio services has grown significantly in Q2 by 28%. So, you know, really everything points to us continuing to build out our leadership position and really being the down and player for some gene supply chain solutions.

speaker
Punit Suda
Analyst, Learing Partners

Got it, okay, helpful guys,

speaker
David

thank you.

speaker
Operator
Conference Call Operator

And your next question comes from David Larson with BTIG. Please go ahead.

speaker
David Larson
Analyst, BTIG

Hey, I hop on the call a little bit late, I'm traveling. Can you just talk about how MVE results came in relative to own expectations? It looks like it was up 8% year over year, that was pretty good for me. Any more color there would be very helpful and it looks like it's kind of turned around and it's now growing again.

speaker
Robert Stavanovic
Chief Financial Officer, Cryoport

Yeah, I think, you know, look, MVE performed well, you know, with 8% growth year over year. You know, we have seen certainly improved demand for MVE's products and as we said in our press release as well, MVE is also bringing out new products into the market. So there's also innovation going on that we believe will drive demand and further demand as well. You know, on the margin side, you know, they're showing strong robust margins. You know, they've grown margins over prior year, about 2.6 percentage points to 44.9%. So it's a strong, good business, it's a profitable business. And, you know, as you know, it's again, it's by far the leader globally for cryogenic systems. So that includes the doers, the freezers and related accessories on a global basis.

speaker
David Larson
Analyst, BTIG

That's great. And then can you just talk about the broader market like the CRO space was under pressure earlier in the year. There's a lot of uncertainty around like the IRA, different like three different executive orders, tariffs. And then it looks like maybe CRO sort of came back with demand now progressing. What are you seeing in terms of overall sentiment from your customers, clinical trial activity, demand for the doers? Just more color there would be very helpful. Thank you. Yeah, so,

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

you know, obviously you can see by our clinical trial count and the increase that the market continues to be very resilient and positive for us as it relates to cell and gene clinical engagement. You know, we have extensive engagement with the CRO community as well as the CDMO community. The CDMO community has come back with very strong results, which we think demonstrates the strength of the space since they are the, obviously the leader in the actual production of a lot of these clinical materials, you know, that ultimately we move from one place to another. So, you know, overall I think that the sentiment in the cell and gene environment, despite, you know, obviously some of the shorter term funding challenges that you see in earlier phase programs as well as the FDA have not impacted our portfolio and obviously have not impacted the CDMO community. So we're very positive overall.

speaker
David

Thanks

speaker
Dr. Mark Sawicki
Chief Scientific Officer, Cryoport

very much. Let's start a good quarter, congrats.

speaker
David

Thank you.

speaker
Operator
Conference Call Operator

There are no further questions at this time. I'm pleased to turn the call back over to Gerald Shelton.

speaker
Gerald Shelton
Chief Executive Officer, Cryoport

You ended there pretty quickly. Thank you very much for your questions, all of you, and thanks for the discussion. In closing, we delivered a strong second quarter performance across all areas of our life sciences business. The life sciences services business, which is a key to our future growth, grew 21% year over year, led by 28% increase in bio storage, bio services, revenue and a 33% gain in commercial cell and gene therapy support. We also saw an increase in demand in our life sciences products, which generated a solid 8% revenue growth for the quarter. We wanna thank you for joining us today. It was a great quarter and we appreciate your continued support, interest in our company, and we look forward to speaking with you again when we report on our third quarter financial results. We wish you all a good evening.

speaker
Operator
Conference Call Operator

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

Disclaimer

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