Good afternoon, and welcome to Cryoport's Second Quarter 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 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 Science 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 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. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Thank you, Todd. 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. 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 BioStorage/BioServices 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 made -- we also continued to expand our product portfolio with the launch of our next-generation MVE SC 4/2 and SC 4/3 vapor shippers, which offer medical and animal health professionals, improve 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 MVE's high-efficiency 800-seat 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…

[Operator Instructions] And your first question comes from Kyle Crews with UBS.

Could you please provide a brief update on the non cell and gene therapy demand that appears to be driving the product revenue beat in the quarter? And could you provide an update on IntegriCell and how the adoption there is going?

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

Yes. So IntegriCell continues to progress nicely. We are moving forward with -- I'm sorry, just give me 1 second here. Sorry, can you repeat the first part of the question?

The first part was on MVE, maybe I'll step in Mark you. MVE, we are feeling better than we were about 6 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 systems sales. Go ahead Mark, on IntegriCell.

I apologize for the mix up. Yes. So IntegriCell 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 our first clients right now, which takes a little bit of time, but that that's going to start to help support the revenue contribution later this year and into next year.

Great. And then maybe as a follow-up there, you maintained the guidance but you had a really great quarter, and it seems like there's 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 guide?

Yes. 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 we -- that's why we reaffirmed it the way it is.

Your next question comes from David Saxon with Needham.

Great. Congrats on the quarter. Maybe just a follow-up to that last question on guidance. Just comp I guess, third quarter, it looks to be an easier comp and then -- easy comp, but slightly harder in the fourth quarter. So how should we think about growth exiting the year, and any early thoughts on 2026 just given the momentum you're seeing? And then I'll have a follow-up.

Just on '26, obviously, on '26, we'll give guidance typically at year-end. We are providing some outlook in our review, please that's posted on our website. related to the expectations on BLA/MAA 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, 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 the first half of the year and the second quarter, obviously, we made significant improvements in terms of gross margins, both on products and services, bringing total gross margin to 47%. So that's a significant increase over prior year. And then from a bottom line perspective as well, if you look at the adjusted EBITDA from continuing operations were for Q2 had 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 everything is moving in the right direction. Revenue growth, gross margins as well as the bottom line. And we certainly want to push that forward during the second half as well. So that's I think as much as we can say at this point.

Okay. Great. No, that was super helpful. 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 repurchases over the last couple of months, but I 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 would love your updated thoughts there.

Yes, David, we did buyback 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 as we think it's significantly undervalued in the market.

Just to put a number on it, we did buyback 1 million shares since our last report.

Yes. And may just to add, obviously, cash is king in this environment. We did pay back the 2025 convertible notes about $14 million during the second quarter, and we obviously would want to maintain a strong balance sheet while evaluating the various options that we have to apply our capital on, and cash.

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 repurchases, is that the message?

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 our focus right now is internal. We have some -- 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.

Your next question comes from Matt Stanton with Jefferies.

I wanted to kind of zoom out for a higher level question, maybe 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 to patient volumes and any more color on timing as it relates to that update that we got late in the quarter?

Matt, we -- 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 will make it much easier for everyone in the system. And it will certainly make it easier for rural points of care and so forth. And Mark may want to add to that?

Yes, I mean, Jerry is absolutely correct. It should have a definitively a 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.

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

Certainly, there's enough capacity for manufacturing in the industry right now. And I think that Mark might want to be -- he might want to comment on that further.

Yes. 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. Our focus is really on the clinical and commercial space. And the vast majority of our clients are well funded and have significant relationships with in large pharmas and others. So we don't anticipate a negative impact from that perspective. And in fact, obviously, I think the demonstration of the continued increase in acceleration of the clinical trials supported up to 728 and an increase of 44 year-over-year, an increase in Phase III trials demonstrates the continued support of that portfolio, which will have significant benefit for us over time.

And maybe just 1 more if I could sneak in. 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 numbers...

I think we're certainly going to try to sustain it during the second half. Typically, we would expect gross margins to increase further just due to operating leverage but we do have some newer initiatives, as you're aware, like IntegriCell 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 for modeling purposes to keep it relatively flat.

It would be a temporary impact.

Yes. Our stated goal based on reaching operating leverage is really to get to gross margins in excess of 55% with adjusted EBITDA margins of 30%.

And we think that's highly achievable, Matt, over time. It just takes a little time.

Your next question comes from Paul Knight with KeyBanc.

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

To be honest, we're seeing more and more of folks that really want the security supply and the scalability that we offer. We're supporting the vast majority of the commercial space today and are 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 Bioservices revenue. And we're also very active on integration. So most of the bigger players that you may be referring to actually want to 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 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.

Yes. 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-controlled supply chain solutions are picking up steam.

And Jerry, on MVE, do you feel like in the biopharmaceutical market that I guess it was destocking post COVID, do you think that's starting to be bottoming at this juncture?

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 3 good quarters at MVE with a solid 8% growth this past quarter. And so I think it's returning to normalcy.

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 IntegriCell. So top line should drive natural EBITDA progression? Is that kind of the logic?

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, IntegriCell being one of them and with that also the build-out of our facilities 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 -- later in the second half. But in general, yes, we're certainly driving towards profitable revenue and positive EBITDA.

Your next question comes from David Larsen with BTIG.

This is Jenny on for Dave. 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 the full costs or partial costs to customers and what their appetite to accept those higher cost has been?

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

Your next question comes from Subbu Nambi with Guggenheim Securities.

This is Thomas on for Subbu. I just want to touch on the guide again. Can you just talk about where the offset is to that headwind from lower Sarepta revenue in the reiterated guide? Is that just stronger performance across the portfolio?.

I think in general, it's just a strong 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 the product lines.

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 derisked at this point?

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 or a factor in our guide.

Okay. And then if I could just sneak 1 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?

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

Our next question comes from Mac Etoch with Stephens Inc.

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 what has the feedback been thus far?

Overall, it's been extremely positive. Folks are excited to see what 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 DHL competencies on a complementary basis. So overall, I think very, very positive.

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

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

I'll turn it over to Mark, but -- in just a second, but I -- IntegriCell 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 or 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.

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

Your next question comes from Puneet Souda with Leerink Partners.

So first one, I just wanted to confirm, that was $2 million headwind 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 AAV, gene therapy programs or clients. You talked about 5 of them that you're supporting, they received negative opinion by FDA. I just wanted to make sure if that's -- those 2 issues are tied together.

I turn the technical side, the gene side over to Mark in just a moment. But Puneet, we haven't baked anything into 2026. We haven't commented on 2026, and we will -- but we will 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 of your question, Mark, do you want to answer that part?

Yes. I view this really as just -- you had a change in administration, you had a change at the FDA, which obviously, they had a to get in and get their feet wet, so to speak. And I think that some of the data that you've seen is then just really trying to get an understanding of the space a bit and taking a little bit more cost around the data side of some of these filings. So you have that as obviously a little bit of caution but you also see very positive responses from the FDA as it relates to things like REMS, so I think that on a whole, we don't see any material impact to 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 Puneet, 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.

Got it. Okay. And then on MVE, could you clarify which end market where you saw the most growth. The animal side? Is it the pharma? Maybe just walk us through which business line actually drove MVE growth for you, maybe in the distributor channel.

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

So majority of the growth was in APAC. Just wanted to clarify 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?

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

Got it. Okay. And then maybe just last 1 for me. With -- you highlighted DHL, but just wondering, are you seeing any change in the competitive landscape overall? 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 competitive dynamics or the market share for clinical trials?

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 or referring to. So nothing significant there to talk about other than, It's positive.

Yes. And as you can see from the data, we're continuing to increase the number of clinical trials we support, we're continuing to fortify our leadership position via the expanded solutions. And you can see the BioStorage/Bioservices has grown significantly in Q2 by 28%. So really, everything points to us continuing to build out our leadership position really being the dominant player for cell and gene supply chain solutions.

And your next question comes from David Larsen with BTIG.

I hopped on the call a little late on traveling. Can you just talk about how MVE results came in relative to your own expectations. It looks like it's up 8% year-over-year on [ expensive range ], any more color there would be very helpful. And it looks like it's kind of turned around and it's now growing again.

Yes. I think, look, MVE performed well with 8% growth year-over-year. 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. On the margin side, they're showing strong, robust margins. 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 as you know, it's -- again, it's by far the leader globally for cryogenic systems. So that includes the [ dewars ], the freezers and related accessories on a global basis.

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,a different like -- 3 different executive orders, tariffs, and then it looks like maybe CRO sort of came back with demand now progressing. Just what are you seeing in terms of overall sentiment from your customers clinical trial activity demand for the [ dewars ]? Just more color there would be very helpful.

Yes. So obviously, you can see by our clinical trial count, and the increase that the market is -- continues to be very resilient and positive for us as it relates to cell and gene clinical engagement, 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 that ultimately we move from 1 place to another. So overall, I think that the sentiment in the cell and gene environment despite, 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.

[indiscernible] Good quarter. Congrats.

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

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 a 28% increase in BioStorage/BioServices 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 want to 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.

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