Good afternoon, and welcome to Cryoport's First Quarter 2025 Earnings Call. All participants will start in a listen-only mode. Following the presentation, there will be a question-and-answer session. As a reminder, this call is being recorded. I will now turn the call over to your host, Mr. Todd Fromer from KCSA Strategic 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 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 describing 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. 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, ladies and gentlemen. 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. As a reminder, we have uploaded our first quarter 2025 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 do not have a chance to read it, I would encourage you to go to the 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 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% year-over-year growth and helped to drive meaningful adjusted EBITDA 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% year-over-year, which included our support of commercial cell and gene therapies, which grew 33% over last year. Life Sciences Services now account for 56% 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% of cell and gene therapy trials. Subsequent to the quarter end, a new therapy from our customer, Avino Therapeutics was approved, bringing our total commercial therapy supported to 20. In the first quarter, six BLA MAA 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 Breyanzi 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, four 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% 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 CryoPDP 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 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 are 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 7.5% 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 costs of raw materials, such as electronics, aluminum, and 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 IntegriCell 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. Your first question comes from Kyle Crews with UBS. Please go ahead.

Thank you for taking the questions here. Could you give us a brief update on the launch of IntegriCell and how the end client adoption is going there? And could you touch upon CGT trial growth? And specifically, I think I calculated around high single-digits 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 going to turn it to Dr. Sawicki, who can answer your questions about the market, especially IntegriCell and our advancements. But we see the market very positively. We see all those things that I mentioned in my opening remarks. We see commercial revenue continuing to ramp with the growth in the 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. Yes, just to further expand on what Jerry said, 2024 was a decent year from a financing standpoint, cell and gene therapy space grew about 30% from a financing standpoint, which is obviously stabilizing the market and providing a significant fund for these companies' continued progress in their clinical and commercial portfolio. Commercial therapies are continuing to progress nicely. 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. 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 will 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 IntegriCell. So IntegriCell is progressing very, very nicely. As we had mentioned previously, both facilities in Houston, Texas, and in East Belgium are open, and we also already have multiple commercial contracts and are currently onboarding multiple programs into those facilities. So it's progressing nicely.

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

For contingent consideration, 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 moderately positive on adjusted EBITDA.

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

When I look at the adjusted EBITDA loss, it's sort of a minor amount, but it looks like there's a drag 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 Q1 of last year, based on the initiatives that we took in 2024.

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

Yes. 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 have a fair amount of uncertainty, 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 undervalued, and we certainly have an authorization for stock buyback, so that will be a consideration at the time we look at the uses of the cash.

Thank you. The next question comes from Puneet Souda with Leerink Partners. Please go ahead.

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

Yes. If you look at the gross margin for the company and services and products, you're absolutely right. We saw a significant increase in the services gross margin for Q1 year-over-year. And we do expect to see more leverage from our core services in the cell and gene therapy space for our services. So over time, you will see an expansion of the gross margin for the services side. We do also have a couple of newer initiatives that will still depress somewhat that growth in gross margins, such as IntegriCell that is just starting to ramp. So, we do expect strong gross margins to continue throughout '25, and certainly as you look into 2026 and 2027, we expect margin improvements beyond what you're seeing today.

Got it. And then on the clinical trial start, I was wondering if you could offer any color about how small versus large pharma is performing. We've heard comments from the broader tool space that SMID 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. Yes, we've seen it be very balanced. We're seeing contributions on the ads from both the biotech as well as the large pharma environment. What we're seeing overall is those biotechs that have promising pipelines are seeing additional interest from 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 adds and 22 removes, so we reported a net increase of 10, but it was a strong amount of adds in Q1 for our clinical trials.

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

Hi. Congratulations on a good quarter. 10% year-over-year revenue growth looks pretty good to me. Jerry, you already mentioned some of this in your prepared comments, but can 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 year-over-year decline in their services bookings. The CROs are under pressure. Are you seeing, like, what is the response from your clients and 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.

Yes. So, 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 products, which have high volume, large revenue streams. The majority of the cell and gene therapies out there are for very specific indications, and they are the only products available to address the particular etiology based on the fact that they've already gone through all the alternatives and 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. So we're not seeing a lot of concern.

David, we are still observing an increase in commercial revenues, and as we anticipated, commercial therapies are developing and being introduced to the market. Therefore, we remain 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. David, most of the product, if you will, the therapies are 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 Atulya side.

Okay. And you also answered this already, but I'm going to ask again, in terms of like 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 going to pass them through to your clients through surcharges. So you're not expecting any increase in costs or margin pressure. Is that correct?

Partially correct, David. But 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 surcharges we can extract at the time that they're not. So we will protect our margins, and I don't think this is unusual for anyone, but 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 bottomed, but it's coming back up. Is that...

Yes. I mean, the demand did grow 2% in products year-over-year, and the revenue in particular from North America has improved over the past three quarters. 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 will continue.

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

Thank you for taking my questions. How much do 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?

Yes, I don't think we can quantify 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 going to 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 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, Subbu, you're asking about?

Yes.

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 supporting modality. So I do think there's an interest there from the administration to see continued progress there.

Just keep your heads down this too shall pass. I mean, you still believe in the modality is the messaging here?

Yes. 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, Subbu.

Thank you. The next question comes from Tejas Savant with Morgan Stanley. Please go ahead.

Edmund, I'm for Tejas. 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 HE 800? And how much of the demand stabilization can be credited to these two products?

Mark, would you like to take that question?

Sure. On the HV3, the HV3 has been very, very well received from a market standpoint, and adoption is ongoing as we speak. It will 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 HE 800, Mark, but go ahead, Robert.

Yes, 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 MBE suite of freezers and accessories. 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 circling back to one of the earlier questions on IntegriCell. Can you guys provide some color on how the on-boarding process has been? And when can we expect to see some more meaningful revenue contributions from your earlier customers?

Yes. So the on-boarding process has been very smooth. As I had mentioned, we're already under multiple contracts including top 10 pharma who have asked us to step in and support aspects of their cell and gene 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 verified, which takes a few quarters. But those are running very, very smoothly, and the feedback has been extremely positive.

The next question comes from Matt Stanton with Jefferies. Please go ahead.

Hi, guys. I wanted to touch on the leading indicators. You talked about both orders stabilizing for Life Science Products, but also engagement levels increasing meaningfully for the Life Science Solution side. So any way 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 anything more kind of flavor you can provide around some of those leading indicators you talked a little bit earlier? Thank you.

You want to talk about the...

Yes. On the service side, I think there's a few things that you can look at, 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 health in our service business. We also continue to see very nice diversification, as evidenced by the increase in our BioStorage and BioServices revenue, which was up 22.5% year-over-year. So both of those are an indication of the onboarding of new clients, which seems to be re-accelerating based on the clinical trial acquisition, as well as you see robust growth in our other services, ancillary services like BioServices, 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 that 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 DHL acquiring our CryoPDP, UPS expanding their healthcare and the other players like Cardinal, McKesson, and Syncora 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 color. And then maybe one for Robert, 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 digits 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 sub-segments between products and services for the full year here? And 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.

Yes. 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, we'd say 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 BioStorage, BioServices growth of 22%. So even if you look at commercial revenue, if you look at a trailing twelve-month basis, about 26% year-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.

The next question comes from Paul Knight with KeyBanc. 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.

Yes. The strategic relationship with DHL is an incredibly strong relationship for us. It will help increase our competitiveness in Asia Pac and EMEA. We will continue with our CryoPDP as a partner and as a part of DHL, and that will be CryoPDP 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 margin metrics for us as a company going forward longer-term, it's significantly also an improvement in margins for the continuing operations.

Thank you. There are no further questions at this time. Let me turn the call over to the management 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 BioStorage, BioServices 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 Products 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 want to thank you for joining us today. We appreciate your continued support and interest in our company, and we're looking forward to updating you on our progress when we report on our second quarter financial results. Good evening to all.

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