CryoPort, Inc.

is an only mode after the speaker's presentation. There will be a question and answer session and instructions will be provided at that time. As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Fromer from KCSA Strategy Communications. Please go ahead, sir.

Thank you. 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 items 1a, risk factors, and elsewhere in our annual report on Form 10K to be filed with the Securities and Exchange Commission and those described from time to time in other reports, which we file with the Securities and Exchange Commission. It is now my pleasure to turn the call over to Mr. Gerald Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Thank you, Todd. Good afternoon, ladies and gentlemen. 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. As a reminder, we have uploaded our first quarter, 2025 in review document to our website. It can be found on the main page of the Cryoport Inc website. This document provides a review of our financial and operational performance and a general business outlook. If you've not had a chance to read it, I would encourage you to go to our website and download it. Before I review our results, I would like to highlight that due

to

our recently announced strategic partnership with DHL and the related sale of CryoPDP to DHL, CryoPDP's financials, which were previously a part of Cryoport's Life Sciences Services Reportable Segment, are now presented as discontinued operations. Accordingly, we have provided quarterly historical information on this basis for 2024 in our first quarter, 2025 in review document. This information is intended to support financial modeling efforts for those needing this information. Please note that unless indicated, all revenue figures discussed today will refer to continuing operations. This includes our fiscal year 2025 revenue guidance first shared alongside our DHL transaction announcement. Now I'll provide a brief update on our business, and then we will take your questions. Cryoport had a solid start to the year with $41 million of revenue from continuing operations for the first quarter, which represented 10 percent -over-year growth and helped drive meaningful, adjusted a bit to improvement. Three things that excited us about the first quarter were first, client engagement and Life Sciences Services grew substantially, highlighting a new momentum in our business. Second, order patterns for our Life Sciences products continued to show signs of stabilization. And finally, our strategic partnership with DHL. Life Sciences Services revenue in total increased 17 percent -over-year, which included our support of commercial cell and gene therapies, which grew 33 percent over last year. Life Sciences Services now account for 56 percent of total revenue, and it continues to be driven by the increasing development and commercialization of cell and gene therapies, which we believe will persist even in the current economic environment. As of March 31st, Cryoport supported 19 commercial therapies and 711 clinical trials, representing approximately 70 percent of cell and gene therapy trials. Subsequent to the quarter end, a new therapy from our customer, Vino Therapeutics, was approved, bringing our total commercial therapies supported to 20. In the first quarter, six BLA-MMAA filings occurred. Three filings were for new therapies, and three filings were for geographic expansion. Additionally, BMS received a supplemental approval from the European Commission to expand the label of Brionzi as a third-line treatment for relapsed or refractory follicular lymphoma. For the remainder of 2025, we anticipate up to an additional 17 application filings for therapy approvals, and additional four approvals for label or geographic expansions or moves to earlier lines of treatment, all of which give us further confidence in our growth forecast. Our Life Sciences products business continues to show further signs of demand stabilization and grew 2 percent year over year. We are continuing to expand our product portfolio to capture new revenue streams with innovative products, including the MVE High Efficiency 800C, which was released in the first quarter and meets the needs of facilities that have limited space yet require high capacity and security. Another key milestone this quarter was the announcement of our strategic partnership with DHL Group. As a part of our strategic partnership, DHL acquired Cryo PDP for an enterprise value of $195 million, which we expect to close in the second or third quarter. We think this arrangement will enhance our positioning in Asia Pac and EMEA and reshape our competitive profile within the industry by leveraging the global scale and capabilities of our new strategic partner, DHL. Our strategic shift in responsive is responsive to market changes driven by the evolution and progress of our industry and provides us with a strong infusion of capital, a substantial return on investment, and a strategic partnership that enables us to sharpen our focus on our core of the Life Sciences service offerings directed toward the rapidly growing regenerative medicine space. Consequently, we're confident in our organic growth outlook for the full year and are confirming our revenue guidance for fiscal year 2025 in the range of $165 million to $172 million, which at the midpoint represents a .5% growth relative to fiscal year 2024. Before we begin to take your questions, I want to briefly talk about global tariffs. In situations where tariffs may impact our business, such as potential increases in cost of raw materials, such as electronics, aluminum, stainless steel, we have already taken steps to diversify our supply chain. In situations where we cannot mitigate tariff charges, we will implement surcharges. We have successfully taken a similar approach in the past. For example, during the supply chain challenges experienced during COVID, we were able to maintain solid financial margins. To be clear, we are beginning to see impact from tariffs on aluminum, and we will pass those costs through a surcharge as appropriate. We feel confident in our ability to manage potential future cost increases due to tariffs. More broadly, we do not expect tariffs to impact our core support of clinical trials or commercial therapies. Of course, we will continue to assess the situation and keep you updated as more information becomes available. In closing, we made meaningful progress during the first quarter in revenue generation, operational improvements, and with the DHL strategic partnership. With this progress to accelerate our growth, we remain focused on supporting the increasing number of commercial regenerative medicine products and the rollout around the world. We are also advancing our key initiatives such as Integra Cell Cryopreservation Solution, our global supply chain center network, and introducing new services and products in order to better serve our clients and open up new revenue streams. We remain confident that the actions we have underway and our momentum will lead us to a return to positive adjusted EBITDA during 2025. This concludes my prepared remarks. So now I will ask the operator to open the lines for your questions.

Thank you. 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 touchtone phone and you will hear a prompt that your hand has been erased. Should you wish to decline from the polling process, please press the star followed by the number two. If you use the speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Kyle Cruz with UBS. Please go ahead.

Hey, thank you for taking the questions here. Could you give us a brief update on the launch of IntegraCell and how client adoption is going there? And could you touch upon CGT trial growth? And specifically, I think I calculated around high single digit growth there. Could you speak to the health of the market given some of the negative news flow that we're hearing? Thank you.

First of all, I'll speak to the market and then I'm gonna turn it to Dr. Sawicki who can answer your questions about the market and especially IntegraCell and our advancements. But we see the market very positively. We see all those things that I mentioned to you in my opening remarks. We see commercial revenue continuing to ramp with the growth of number of commercial therapies, continuing to grow. The growth in the addressable market of our customers' therapies and the growth in the number of clinical trials we support. So we're bullish and we are well on our way to building our company to that profitable growth bridge that I've mentioned several times. Mark, would you take the rest of the questions?

Sure, happy to do so. Yeah, just to further with Jerry, you know, 24 was a decent year from a financing standpoint. Stella and Dream Therapy Space grew about 30% from a financing standpoint, which is obviously stabilizing the market and providing a significant fund for our companies to continue to progress their clinical and commercial portfolio. You know, and commercial therapies are continuing to progress nicely. You know, we were up to 20 approved therapies that we support at this point in time. And there continues to be a robust pipeline overall, which is very exciting. You know, we anticipate, as Jerry said in his opening remarks, up to 17 additional filings this year, potentially another four therapy approvals and four label expansions. So that's a very robust year. And we'll be consistent with the record year that we saw last year from an approval standpoint. So it continues to be very nice and robust. Turning to IntegraCell, so IntegraCell is progressing very, very nicely. As we had mentioned previously, both facilities in Houston, Texas and Lees, Belgium are open and we also have, and already have multiple commercial contracts and are currently onboarding multiple programs into those facilities, so it's progressing

nicely. Great, thank you.

Thank you. The next question comes from Richard Baldry with Roth Capital. Please go ahead.

For contingent

consideration, it changes that, is there a reason that isn't backed out as sort of a one-time event? Because I think, if my math is right, without that it'd be, you know, moderately positive on adjusted EBITDA.

Sorry, Rich, we're cut off from you. Can you please restate your question?

When I look at the adjusted EBITDA loss, it's, you know, sort of a minor amount, but it's including a drag, it looks like, from contingent consideration. I'm just curious why that, as a one-time event, wouldn't have been backed out of that number, because if my math is right, it looks like you'd be positive EBITDA without that drag.

No, we did back it out. It goes the other way. So we had a contingent consideration at year end that we released in Q1 related to one of the acquisitions. So we did back that out. But having said that, obviously the adjusted EBITDA did improve significantly over, you know, Q1 of last year, based on the initiatives that we took, you know, in 2024.

Got it. And, you know, post the divestiture, you know, whenever it closes, and you'd have a pretty disproportionate now amount of net cash versus your market cap. Can you talk about what you think the appropriate steps to bolster shareholder value would be, you know, given that very large cash reserve versus, you know, pretty modest adjusted EBITDA losses?

Yeah, Rich, we will be prudent in the way we allocate that cash, the use of that cash and so forth. Of course, we're living in some times that are, you know, have a fair amount of uncertainty in them, but we'll be prudent, we'll be opportunistic, and we'll be careful about the way we allocate that cash. One of the things we will consider is the fact that our stock is highly, highly undervalued, and we certainly will, we have an authorization for stock buyback, and so that will be a consideration at the time we look at the uses of the cash.

Great, thank you.

Thank you. The next question comes from Punnet Soda with Learing Partners. Please go ahead.

Hi, you have Michael on for Punnet. Thank you for taking my question. My first one has to do with the service growth margins. I'm getting about like a 500 base point -over-year expansion. So I'm curious if, like what's driving that growth, and also if we should expect a similar -over-year expansion in the balance of the year.

Yeah, if you look at, you know, the growth margin for the company and services and products, you're absolutely right, and we saw a significant increase in the services growth margin for Q1 -over-year, and we do expect to see more leverage from our core services in the Southern Gene Therapy space for our services. So over time, you will see an expansion of the growth margin for the services side. We do, however, also have a couple of newer initiatives that will still depress somewhat that growth and growth margins, such as Integra Cell, that is just starting to ramp. So we do expect strong growth margins to continue throughout 25, and certainly as you look into 26, 27, we expect margin improvements beyond what you're seeing today.

Got it, and then on the clinical trial start, I was wondering if you'd offer any color about how small versus large pharma is performing. We've heard comments from the broader tool space that Smith caps have been kind of pulling back and large pharma has been a bit healthier. I was wondering what your view on the market is.

Mark, why don't you take that?

Sure, yeah, we've seen it be very balanced. We're seeing contribution on the ads from both the biotech as well as the large pharma environment. You know, what we're seeing overall is those biotechs that have promising pipelines are seeing additional interest from bit large pharma where they're continuing to resource and put money into and purchase licensing agreements for a lot of these product lines. So it's maintaining a robust flow from both.

Maybe to add into that, in Q1, we did have 32 ads and 22 removes from our, so we reported a net up 10, but it was a strong amount of ads in Q1 for an interclinical trial.

Correct, yep, correct. Thank you.

Thank you. The next question comes from David Larson with BTIG. Please go ahead.

Hi, congratulations on the good quarter. 10% -over-year revenue growth looks pretty good to me. Jerry, you already mentioned some of this on your prepared comments, but you talk about just the broader macro environment. How are your clients responding to potential 25% tariffs? There was this executive order for drug pricing signed on April 15th. There's the ongoing impact from the Inflation Reduction Act. IQVIA had a -over-year decline in their services bookings. The CROs are under pressure. What is the response from your clients and demand, the demand side of your business, if any? Thank you.

David, we really don't have any significant tariff impact on cell and gene therapy. So we're moving along pretty well. Mark, you may wish to add to that.

The positive thing is the vast majority of those actions that you talked about from a government standpoint are really focused around small molecule and biologic drug product, which has high volume, large revenue streams. Vast majority of the cell and gene therapies out there are for very specific indications, and they are the only product available to address that, the particular etiology based on the fact that they've already gone through all the alternatives and there are many of the alternatives. So the pressure there is, I think, a lot different. We're not seeing a lot of concern. I'm actually down at ISCT right now, which is the International Society of Cell and Gene Therapy Conference, and the mindset here has been pretty positive. We're not seeing a lot of concern.

So David, we're continuing to see the commercial revenues ramp, and we're continuing to, as we forecasted, continuing to see commercial therapies maturing and come into market. So we're very optimistic.

Okay, so a lot of the source materials come from the United States, so they wouldn't be impacted by tariffs, is that correct?

Correct. Yeah, David, most of the product, if you will, the therapies, the cells are taken right from the sick patients. So the patients are in the same countries where it's, I'll call it, manufactured and then sent back to the patient on the etolgeous side.

Okay, and you also answered this already, but I'm gonna ask again, in terms of your own cost of goods, seems like there's a lot of technology you're working with. You got the doers, you got the technology on the doer, all those electronic components. There's transport costs. And I heard you say that those tariffs, if they happen, you're gonna pass them through to your clients through surcharges, so you're not expecting any increasing costs or margin pressure, is that correct?

Partially correct, David. You know, we have an incredibly able sourcing team, and we've already worked on mitigating tariffs by changing supply chain routing or supply chain sources and so forth. And as I mentioned in the opening comments, those that are passed on to us through components or those that we cannot mitigate, we will put into surcharges because we don't think this will be permanent. We think that in surcharges, we can extract at the time that they're not. But so we will protect our margins. And I don't think this is unusual for anyone, but so we feel like we have this under control for sure.

Okay, one last quick one, please. Product revenue grew year over year. Just any color there in terms of ongoing demand looks like it's not only bottom, but it's coming back up. Is that?

Yeah, I mean, the demand did grow 2% in products year over year. And the revenue, in particular from North America, improved over the past three quarters, and we expect that trend to continue as our products are made in America and they won't be subject to tariffs. So while global markets have been disrupted somewhat, the Americas are showing resilience and incremental revenue growth as they have for the last three quarters, and we predict that'll continue.

Okay, I'll hop back in the queue. It looks like a good quarter. Thank you.

Thank you.

Thank you. The next question comes from Sido Nambi with Guggenheim Securities. Please go ahead.

Thank you for taking my questions. How much does supply chain initiatives actually improve margins? Any chance you could quantify that as well? And will that be a long-term improvement to margins or is that a more short-term fix?

Yeah, I don't think we can quantify it necessarily in terms of impact on margin. I think the most important part of the surcharges is to ensure that our margins are not negatively impacted by these tariffs. So I think the margin improvement is really gonna be driven largely by the expansion of our services, leveraging the client base that we have and leveraging the growing number of commercial therapies.

Thank you for that. And one follow-up, probably the elephant in the room is the new FDA director who seemingly has a more, for lack of a better way of saying, stricter stance to newer modality therapy. Anything that you're messaging to your current shareholders.

That's about the new head of CBER. Subu, you're asking about?

Correct. The new head of CBER is an accomplished scientist. He may have some conservative views that have been reported and so forth, but he's a conservative scientist. He's quite accomplished. And as a scientist, we feel that the data will rule. So there may be more stricture in structure and so forth as we move forward, but we're very optimistic about his service and about his qualifications.

And the Trump administration has also come out implicitly in favor of cell and gene therapy as a modality. So I do think there's an interest there from the administration to see continued progress there.

Which is, keep your head down, this too shall pass. And we'll be, you still believe in the modality is the message in there.

Yeah, and at the end of the day, the safety and efficacy of these therapies is being proved out every day. And that's the main theme, I think, to keep on your mind,

Subu. Thank you guys. I'll hop back in the queue.

Thank you. The next question comes from Teja Sevent with Morgan Stanley. Please go ahead.

Edmund, not contagious. Thank you for the time. Maybe to start off, can you guys share some color on how the traction has been with your new launches in the product side? How has the demand been for HV3 and the new HE800? And how much of the demand stabilization can be accredited to these two products?

Mark, would you like to take that question?

Sure, on the HV3, the HV3 has been very, very well received in a market standpoint and adoption is ongoing as we speak. It'll be rolling into a substantial number of our commercial therapy support mechanisms over the next 12 to 18 months. So that's been extremely positive. What was the other product you were asking about?

That's the HE800 at FBE, Mark. But go ahead, Robert.

Yeah, I just wanted to clarify. The HV3 is related to Cryoport Systems and Cryoport Systems Solution. So that's not related to product revenue. Wouldn't be reflected if you look at the product revenue. That's specifically related to the MV suite of freezers and accessories. Got it. And the second product that you mentioned, that's just being rolled out. So that's too early to talk about at this stage.

Got it. And then I'm circling back to one of the earlier questions on Integra Cell. Can you guys provide some color on how the onboarding process has been? And when can we expect to see some more meaningful revenue contributions from your earlier customers?

Yeah, so the onboarding process has been very smooth. As I had mentioned, we're already under multiple contracts, including Top 10 Pharma supporting, that have asked us to step in and support aspects of their cell and teen therapy portfolio from a standardized cryopreservation standpoint. The process takes a little bit of time because there's a tech transfer process where it has to be have go through verification, which takes a few quarters. But those are running very, very smoothly. And the feedback has been extremely positive.

Got it. Thank you guys for the time. Thank you. The next. Oh, by the way,

once again, should you have a question, please press the star followed by the number one on your touchtone phone, and you will hear a prompt that your hand has been raised. The next question comes from Matt Stanton, with Geffrey, please go ahead.

Hey guys, I wanted to touch quick on the leading indicators. You talked about both order stabilizing for life science products, but also engagement levels, increasing meaning flee for the life science solution side. So anyway, you can kind of put a finer point or qualify the order improvement you're seeing or the nature of conversations with customers and potential customers. I think you talked about on the solution side, strength, both deeper penetration at existing clients, but also new clients. So just any more kind of flavor you can provide around some of those leading indicators you talked about a little bit earlier. Thank you.

I can

comment on that.

Mark, you wanna talk about the, Yeah,

on the service side, I think there's a few things that you can look at to look at the, obviously the traction in the service side of our business. The first is our clinical trial portfolio. And the fact that we're now up to 711, we saw a net increase of 10 programs. And a total number of onboarded programs over 30 is a very robust number. And I think that demonstrates that health in our service business, we also continue to see very nice diversification as evidenced by the increase in our bio storage and bio services revenue, which was up 22 and a half percent year over year. So both of those are an indication of, number one is the onboarding of new clients, which seems to be reaccelerating based on the clinical trial acquisition, as well as you see robust growth in our other services, ancillary services like bio services, which demonstrates a nice diversification of that revenue stream in our existing client portfolio as well as new.

I think one other thing, Matt, to keep in mind is the ecosystem that you're seeing keep building around this industry of the cell and gene therapies and regenerative medicine. You're seeing that with like a DHL acquiring our cryo PDP, UPS expanding their healthcare, and the other players like Cardinal, McKesson and Sincora continuing to learn and to turn to the cell and gene space. And we're really focused with our strategic pivot on enabling all of those big companies with where they're going.

Great, that's helpful, Colin. And then maybe one for Robert, just nice to see the reiteration of the guide given the choppy macro backdrop. I think previously you guys had kind of talked about modest growth on the product side and maybe something like high singles or double-digit growth on the service side. So just given a number of moving pieces and some of the news on the commercial side, any change in your outlook between the subsegments between products and service for the full year here? And then just to confirm on China, I think you talked about muted trends in China for the year, but just to be clear, you're not assuming any meaningful demand destruction tied to some of the tariff and trade war items out there. Thank you.

Yeah, just to cover the last point first, China is not included or any change in China is not included in our guidance. So that would be on top of that. But if you look at the guidance and the overall services revenue growth and product revenue growth, it still is the same in terms of the guidance. We certainly see kind of an improved demand coming back on the product side, but still from a guidance perspective, it's a low to mid-single growth for the product side. On the services side, you can see strong growth in Q1, really on all aspects. So whether you look at overall revenue growth on services, the commercial revenue growth of 33%, and like Mark mentioned, the bio storage bio services growth of 22%. So even if you look at commercial revenue, if you look at a trailing 12 month basis, about 26% -over-year growth. So we certainly expect commercial revenue to grow significantly and expect 25 to be a record revenue for the support of our commercial clients.

Great, appreciate all the colors, thank you.

Thank you. The next question comes from Paul Knight with Keyback. Please go ahead.

Hi, this is Anna on for Paul Knight. Thanks for taking my question. I have just one, but maybe touching on the recent news with DHL. I was wondering if you could make any initial comments on the impact of this partnership and if you've seen any benefit of being carrier agnostic, maybe in terms of customer conversations, or if this just increases your ability to meet the incoming pipeline of larger cell and gene therapies.

Thanks. Yeah, the strategic relationship with the DHL is an incredibly strong relationship for us. It will help increase our competitiveness in Asia-Pac and EMEA. We will continue with our cryo PDP as a partner and as a part of DHL, and that will be cryo PDP on steroids because it will have all of the backing and the resources of DHL at its command. And then we have all of the other resources available to us at DHL. So this is a very strong relationship and will, over time, ramp up to be quite significant for us on a global basis.

And maybe just from a financial perspective, if you look at the strategic relationship and transaction itself, it certainly obviously significantly fortifies and strengthens our balance sheet and financial position. And then if you look at kind of the margins, margin metrics for us as a company going forward, in the long-term, it's significantly also an improvement in margins for the continuing operations.

Thank you, that's great.

Thank you. There are no further questions at this time. Let me turn the call over to the manager for closing remarks.

Thank you, and thank you everyone for your questions and for our discussions. In closing, we reported solid first quarter results led by our life science services business, which grew 17% year over year. This included strong increases in commercial cell and gene therapy revenue and bio-storage bio-services revenue, which increased year over year 33% and 23% respectively. At the same time, we continued to see further stabilization of order trends in our life science product segment. In line with our focus on growing our role in supporting regenerative medicine with temperature control supply chain solutions, we are excited about our strategic partnership with DHL. This collaboration will advance our strategy and further enable us as the regenerative medicines industry's essential supply chain company. In addition, it will strengthen our financial profile, as Robert just mentioned, while sharpening our focus on our core business. We wanna thank you for joining us today. We appreciate your continued support and interest in our company. We're looking forward to updating you on our progress when we report on our second quarter financial results. A good evening to all.

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

Thank you.