NASDAQ:CYRX CryoPort Q4 2024 Earnings Report $11.95 -0.24 (-1.99%) As of 10:05 AM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast CryoPort EPS ResultsActual EPS-$0.42Consensus EPS -$0.33Beat/MissMissed by -$0.09One Year Ago EPS-$0.29CryoPort Revenue ResultsActual Revenue$59.53 millionExpected Revenue$58.71 millionBeat/MissBeat by +$827.00 thousandYoY Revenue GrowthN/ACryoPort Announcement DetailsQuarterQ4 2024Date3/4/2025TimeAfter Market ClosesConference Call DateTuesday, March 4, 2025Conference Call Time5:00PM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by CryoPort Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 4, 2025 ShareLink copied to clipboard.Key Takeaways Cryoport delivered $228.4 million in 2024 revenue, with the Life Sciences Services business growing double digits year-over-year and Q4 gross margin improving to 45.8% from 40.6% a year earlier due to cost management initiatives. Support for commercial cell and gene therapies drove a 37% increase in Q4 and a 372% full-year revenue surge, while the company now supports 701 total clinical trials (up 26) and a record 19 commercial programs (vs. 14). The company launched IntegraCell cryopreservation facilities in Houston and Liège and introduced the Cryoport Xpress HP3 shipping system, targeting new revenue streams by standardizing starting materials and improving shipping efficiency. For 2025, Cryoport expects full-year revenue of $240–$250 million, anticipates 23 BLA/MMA filings (up from 11) and projects a return to positive adjusted EBITDA. Despite stabilization signs in the Life Sciences Product segment, macroeconomic pressures and market dynamics weighed on 2024 performance, and order patterns may remain uneven as the company works toward profitability. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCryoPort Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good afternoon and welcome to Cryoport's Fourth Quarter and Full Year 2024 Earnings Conference Call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. As a reminder, this call is being recorded. I will now turn the call over to your host, Mr. Todd Fromer from KCSA Strategic Communications. Please go ahead. Todd FromerManaging Partner at KCSA Strategic Communications00:00:31Thank 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. 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. Todd FromerManaging Partner at KCSA Strategic Communications00:01:14In 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 U.S. Securities and Exchange Commission, and those described from time to time in the other reports which we file with the U.S. 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. Jerrell SheltonCEO at Cryoport00:01:54Thank you, Todd. Good afternoon, ladies and gentlemen. Thank you for joining our Fourth Quarter and Full Year 2024 Earnings Call. 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 Fourth Quarter and Full Year 2024 and 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. Now, I will provide you with a brief update on our business, and then we'll take your questions. 2024 was a tough year for the life sciences. Jerrell SheltonCEO at Cryoport00:02:51The effects of macroeconomic conditions and market dynamics were felt throughout the year. We adapted to the challenges and concluded the year with solid results and total annual revenues of $228.4 million, which is in line with our expectations. Our life sciences service business continued its expansion with double-digit year-over-year growth in biostorage and bioservices revenue during both the fourth and the full year periods. For the full year 2024, our life sciences services business represented 67% of total revenue compared to approximately 62% last year. We saw considerable revenue growth for the support of commercial cell and gene therapies, which rose 37% and 20% for the fourth quarter and full year, respectively. Cryoport continues to expand its market share in the growing cell and gene therapy industry. Jerrell SheltonCEO at Cryoport00:03:55As of the year end, we supported a total of 701 clinical trials, a net increase of 26 clinical trials over last year, with 81 of these trials in phase III. This is a record number of total clinical trials supported by Cryoport, and it is indicative of the potential commercial revenue opportunity that is developing. Moreover, we also saw a record number of Cryoport-supported commercial approvals over the last year, increasing the number of commercial programs we support from 14 to 19. In our life sciences product business, we think our order patterns are beginning to show signs of stability. I would remind you that even with the downturn of the cryogenic systems market, our management team has continued to provide positive free cash flow from this business. Jerrell SheltonCEO at Cryoport00:04:51As previously reported, during 2024, we implemented a number of cost management initiatives in our product segment to align our operations with current global industry dynamics. As cost reduction and capital realignment strategies were implemented across our entire company, we made considerable progress in improving our gross margin. For the fourth quarter of 2024, our gross margin rose to 45.8% compared to 40.6% in the same period last year. We remain confident that these actions that have been taken are taking effect and will lead us to a return to positive adjusted EBITDA during 2025. At the same time, we have continued to advance our most important business development plans, which have been underway for some time, as we strive to balance those plans with our commitment to achieving positive adjusted EBITDA during 2025. We're confident that these undertakings will open up new revenue streams and move us forward. Jerrell SheltonCEO at Cryoport00:05:56For example, in the fourth quarter, we opened our IntegriCell Cryopreservation Solution with new state-of-the-art facilities located in Houston, Texas, and Liège, Belgium. IntegriCell was set up to produce high-quality standardized cryopreserved starting material for the manufacture of cell therapies. Based on market research and our first interactions with prospects and newly signed clients, we believe IntegriCell will generate significant revenue as it offers significant advantages to cell therapy manufacturers, allowing them to produce more consistent, more robust, standardized products more efficiently. IntegriCell addresses a critical aspect in optimizing the supply chain for the development and commercialization of cell-based therapies. Another example is our Cryoport Express Cryogenic CX HV3 Shipping System, or HV3, which was introduced in January of this year. The HV3 is a revolutionary cryogenic shipper that offers our clients enhanced payload production, storage efficiency, mobility, and accessibility. Jerrell SheltonCEO at Cryoport00:07:06With the introduction of HV3, we also improve patient accessibility to vital cell therapies in smaller cities and remote areas as it will fit into smaller aircraft. We believe this will benefit patient outcomes at large. Looking forward in 2025, we believe we are well positioned to further capitalize on the anticipated growth of the cell and gene therapy industry. At this time, we're projecting that 23 BLAs, or MMA filings, could occur in 2025, up from 11 last year. We're happy that 2025 is off to a good start as three filings have already occurred in January. Cryoport's huge base of clinical trials continues to push forward, and we expect to post another record amount of commercial revenue in 2025. Based on all this, we're providing full year 2025 revenue guidance in the range of $240 million-$250 million. Jerrell SheltonCEO at Cryoport00:08:09We intend to maintain our leading market positions, open up additional revenue streams, and unleash our operating leverage as market demand grows. We will complement this with seeking strategic collaborations throughout the year. We're confident that we have taken steps necessary to implement our growth plans and to reach our objectives of positive adjusted EBITDA during 2025. This concludes my prepared remarks, so now I'll ask the Operator to open the lines for your questions. Operator00:08:43Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your telephone keypad. You will hear a prompt that your hand has been raised, and should you wish to cancel the request, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Anna Snopkowski from KeyBanc Capital Markets. Please go ahead. Anna SnopkowskiAnalyst at KeyBanc Capital Markets00:09:17Hi, good afternoon. Thank you for taking my question. This is Anna on for Paul Knight. Maybe to start on the significant and impressive 37% increase in commercial revenue you saw in the fourth quarter, could you walk through some of the drivers there and whether this was broad-based or maybe one commercial therapy that drove this? Thank you. Jerrell SheltonCEO at Cryoport00:09:43I think Mark Sawicki can best answer that question. Mark SawickiChief Scientific Officer at Cryoport00:09:48Yeah, I'd be happy to answer that question. A couple of factors. Number one is it was a broad-based increase. It wasn't focused on one or two clients. Some of the key drivers here are we've seen the advancement of earlier line approvals with some of our commercial clients. We've seen additional companies get approved. We had five commercial approvals last year, and we're starting to see contribution with multiple of those programs as well, as well as our historical programs continue to expand on a geographic basis, as well as they're pushing for line extension into different therapy classes, and all of those have contributed to that strong Q4 performance. Anna SnopkowskiAnalyst at KeyBanc Capital Markets00:10:36That's helpful. Switching to the MVE side of the business, it seems like you saw some stabilization there in the fourth quarter. Do you feel confident that this will continue to stabilize or maybe even recover in 2025? Jerrell SheltonCEO at Cryoport00:10:54We are seeing the order patterns beginning to show some signs of stability at MVE, and we feel that that will continue throughout 2025. It may be uneven, but we think it will continue to progress. Anna SnopkowskiAnalyst at KeyBanc Capital Markets00:11:11Thank you. Operator00:11:12Thank you. Your next question comes from the line of Puneet from Leerink Partners. Please go ahead. Puneet SoudaAnalyst at Leerink Partners00:11:23Yeah, hi guys. Thanks for the questions. First one around the guide for 2025, can you elaborate your expectation for service versus product, and maybe what are the growth assumptions you have by logistics and also the CRYOGENE and the MVE business within the context of guide? Jerrell SheltonCEO at Cryoport00:11:45In the context of guidance, I think Robert will add to what I have to say, Puneet, and thank you for that question. Obviously, services will be a bigger portion of our guidance, and it will grow faster than life sciences products. With that, I'll turn it to Robert to elaborate more. Robert StefanovichCFO at Cryoport00:12:03Yeah, maybe just a few things to put it in context. We typically do not guide on business units directly. What I can say is if you look at the revenue growth in biostorage bioservices, which was double-digit, the bioservices growth, which was 7% year-over-year. In particular, on the cell and gene therapy side, the strong growth on the commercial therapy side, that obviously drives the services business growth. For products, we certainly have to take a more conservative view just based on the comments that Jerry had earlier on this call to really look at very modest increases in product revenue for guidance purposes. It is really driven by the services side. Puneet SoudaAnalyst at Leerink Partners00:12:52Okay. That's helpful. There is quite a bit of discussion on tariffs. Just wondering, is there any impact on the cost of the doors or freezers from any of the steel aluminum tariffs, Canada, Mexico, or otherwise? I'm just trying to understand. I'm sure you've thought through that. Are there any tariffs on the freezers from the China plant or anything that is getting serviced from the U.S.? Jerrell SheltonCEO at Cryoport00:13:25Yeah, we have thought through that. We do have, Puneet, and however tariffs impact us, and we can't tell for sure on all of them except the direct things that we hear about the tariffs on aluminum and stainless steel. We will pass on tariff impacts through surcharges for the period of time that they exist. We don't expect impact on our margin. Would you like to come in further, Robert? Robert StefanovichCFO at Cryoport00:13:57I think that covers it. I mean, I think what we have demonstrated even in the past with some of the supply chain issues that we've had in prior years that the management has been able to really maintain solid gross margins. I think we have quite good control over the cost structure and the ability to ensure that we maintain gross margins for the MVE, for the products business. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:14:25I'd just like to make one thing clear. This is Puneet. The freezers for the U.S. market are made in Ball Ground, Georgia. Jerrell SheltonCEO at Cryoport00:14:32Cryogenic freezers. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:14:33Cryogenic freezers. The cryogenic doors are also manufactured in Minnesota. There is no impact that way for our U.S. business. Puneet SoudaAnalyst at Leerink Partners00:14:42Got it. That's helpful. When I was looking at your clinical trial growth, just a last question on this. That appears to be about net clinical trial growth of about 6% in 2024. Wondering what's your expectation here for 2025? Any impact from NIH indirect cuts? A number of these trials get started in the academic setting in medical schools. Wondering if you're seeing any updates or impact that you're contemplating from any of those institutions. Thank you. Jerrell SheltonCEO at Cryoport00:15:23Puneet, I'll answer the last question first and then turn it to Mark for trial expectations. In terms of the NIH, we have very little exposure to the situation with the NIH. We are not directly concerned about that at this point. Mark, would you answer the second part? Mark SawickiChief Scientific Officer at Cryoport00:15:46Yeah, happy to. Yeah. As you can see with the data itself in Q4, Q4 was the best performance that we've had in, I would say, over the last eight quarters on new trial acquisition. I think that's a manifestation of the improvement in the overall cell and gene spaces as it relates to clinical trial activity. I do anticipate that we will see continued strong performance. I would expect that 2025 will be stronger than 2024 on a new trial acquisition basis. Robert StefanovichCFO at Cryoport00:16:21Puneet, as you'll see in the review document, there's another 23 possible filings in 2025. On the commercial side, there's a lot of activity as well. Three filed already in January. We expect another 10 possible approvals, of which five are new therapies. It's a very robust kind of pipeline of activities within the cell and gene therapy space. Puneet SoudaAnalyst at Leerink Partners00:16:46That's where I would. All right. Thank you. Operator00:16:51Thank you. Your next question comes from the line of Tejas Savant from Morgan Stanley. Please go ahead. Operator00:16:59Hi, this is Edmond on for Tejas. Thank you for the time. Switching back to MVE, can you guys elaborate a little bit more on what you guys are seeing from your customers across your geo regions in terms of seeing early signs of stability? Jerrell SheltonCEO at Cryoport00:17:16The signs of stability are in the order patterns, and that's a collective thing. So as far as I can actually go in answering that question, we see signs of stability. This doesn't say that everything is stable and rosy, but we are seeing those signs of stability that we like to see in that market. Jerrell SheltonCEO at Cryoport00:17:38Got it. Appreciating that your presence in China has gotten smaller over the past few years to about less than 3% of your total. Given the concerns on Chinese retaliations on tariffs, even if nothing has happened yet, to what degree are local substitutes available in the region? Do you continue to think that your in-China strategy is sufficient in securing a position in the market here? Jerrell SheltonCEO at Cryoport00:18:03Yeah. I mean, local sources in China certainly are available, and there are other sources throughout Asia. We are implementing our China-first China strategy as we speak, and we will unveil that later on. Robert StefanovichCFO at Cryoport00:18:23Yeah, and outside of China, again, this is where Tom mentioned. We have our manufacturing facilities here in the U.S. that manufacture the cryogenic freezers and doors for the U.S. market, for the European market. In some ways, we mitigate some of that risk that a lot of other companies have in the space with regards to China. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:18:44Maybe one last thing to add there, Ed, is that in our guide, there is no assumption of a recovery from China. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:18:57Got it. That's helpful. One last one for me. How are you guys thinking about revenue contributions from the five new therapies that were approved in 2024 for your 2025 guidance? With the recent layoffs at the FDA, are you starting to hear customers' concern about longer approval timelines for cell and gene therapies? Jerrell SheltonCEO at Cryoport00:19:17Mark, I don't know that we can give guidance on those five therapies, but I'll let you speak to that question. Mark SawickiChief Scientific Officer at Cryoport00:19:25No, you're absolutely right. We don't break out individual contribution, although we do anticipate that multiple of the new therapies that were launched in 2024 will contribute meaningful revenue to the commercial totals for 2025. That's about as far as I can delineate on that. Regarding the FDA, now, we do not anticipate the activities within the FDA from a governmental standpoint to have an impact on cycle time. In fact, we've seen very robust approval activity, and we continue to see progression there. I wouldn't anticipate a meaningful impact on the 2025 portfolio. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:20:07As a matter of fact, one of our customers today announced that their BLA received and have a PDUFA date in August. Things keep moving forward. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:20:20Great. Appreciate the time and the answers, guys. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:20:23Thank you. Operator00:20:26Thank you. Your next question comes from the line of David Saxon from Needham. Please go ahead. David SaxonAnalyst at Needham00:20:31Oh, great. Good afternoon. Congrats on the quarter, and thanks for taking my questions. Maybe I'll start with Robert just on profitability, the PR noticed or noted expectations for getting to profitability in 2025. Can you just help us around specificity? When might that be? Either by quarter, like first half, second half, and then kind of directional expectations for the year? Should we be thinking break even or any better or worse? And then I'll follow up. Robert StefanovichCFO at Cryoport00:21:06Yeah. Maybe just to frame it a little bit, when we talked about some of the cost measures that we took starting in Q2, we've made good progress. We implemented the majority of those activities, and that really drove that consistent improvement of adjusted EBITDA over the last three quarters, moving from a -$6.6 million to now a -$1.3 million for Q4. On an annualized basis, that equates to about $22 million. That is in line with what we were targeting, actually a little bit better than what we were targeting. We are, of course, focusing on expanding gross margins and driving profitable revenue growth. You have seen a significant enhancement of our gross margins year over year, both for the services revenue as well as for the product revenue. I think we're well on track to continue to execute. Robert StefanovichCFO at Cryoport00:22:00At the same time, we are driving certain initiatives that we have that we believe will drive revenue growth in the near future. That is another aspect to consider. I think in terms of timing of reaching adjusted EBITDA, positive adjusted EBITDA, we can't give you direct timing, but it is our stated goal to reach that during 2025. The timing of it really depends on some of the ramp that we expect to see on the services side, in particular on the cell and gene therapy side. David SaxonAnalyst at Needham00:22:35Okay. Okay. That was helpful. Thanks for that. I wanted to ask on MVE. You're noting order patterns are stable. The quarter was pretty strong at $20 million in dollar terms. Is that a good starting point against the backdrop of order patterns being stable? Is there any mixed dynamic that we should be aware of that would materially change kind of quarterly expectations? Thanks so much. Jerrell SheltonCEO at Cryoport00:23:09There's no mixed dynamic that we can point to right now. David SaxonAnalyst at Needham00:23:17Okay. Great. Thanks. Operator00:23:21Thank you. Your next question comes from the line of Subbu Nambi from Guggenheim. Please go ahead. Subbu NambiAnalyst at Guggenheim00:23:28Hey, guys. Thank you for taking my question. One question. Once a therapy is commercial, what are the drivers of revenue growth to Cryoport on that therapy? Is it just volume ramp for the therapy and indication of something? Or are there opportunities to increase your wallet share with the manufacturer? Mark SawickiChief Scientific Officer at Cryoport00:23:47We pursue both. Yeah. We pursue both avenues. Both ramp in volume from a patient's treated standpoint as well as revenue diversification. In many of the cases, we're seeing that both of those occur. Subbu NambiAnalyst at Guggenheim00:24:07Got it. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:24:08Thank you for asking that. Yeah, you see that in the Bioservices, Biostorage starting to grow. Hopefully, this year, as Mark will probably talk more later on, is that IntegriCell initiative. These are the projects that we've invested in for years that are now starting to get some traction. Subbu NambiAnalyst at Guggenheim00:24:29Thank you for that, guys. You did mention that you expect 2025 to be better, but what have you been seeing with respect to biopharma biotech funding in 2024? What trends are you expecting to see in 2025? Mark SawickiChief Scientific Officer at Cryoport00:24:44Yeah. I think it was $15.2 billion for all of 2024, which was the best year in a number of years. In fact, for cell and gene investment, 2025 is going to be a little bit more challenging from an expectation standpoint. I think it'll be a strong year, but we obviously have to see what happens with the federal government and what's happening there. I will couch that with just a caveat. The markets themselves are very positive. In fact, a lot of the activity that we were at from a trade show standpoint and from a market standpoint, the sentiment overall is much more positive than it has been in a long time. Not s``ure if Tom wants to add anything to that. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:25:28No, other than on our quarterly review document that is on our website, Subbu, when you have a chance to download it on page five, you will see the cell and gene therapy investments by year. It was a really good year in 2024. Jerrell SheltonCEO at Cryoport00:25:41Yep. Correct. Subbu NambiAnalyst at Guggenheim00:25:44Are you assuming the similar levels of funding for 2025 in your guide? Mark SawickiChief Scientific Officer at Cryoport00:25:52Yeah. I mean, we obviously, based on the sentiment that was expressed at some of the JPMorgan, Facilitate, and others, it looks like it'll be a year that we believe will be positive. I would expect, hopefully, that we'll see activity that's at par or even a little bit stronger than 2024. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:26:13Just to maybe clarify, Subbu, that when you think about our guide, especially when you think about our commercial revenue and how we're factoring that, that has nothing to do with funding. These are from large pharma or public companies that aren't dependent on money coming in the door for their commercial ramps. Subbu NambiAnalyst at Guggenheim00:26:35I was just asking that because many of the smaller biotech funding biotech companies saw some struggle during the 2022, 2023 phase. That is what I was hitting on, not so much. I completely understand you come more on the commercial and probably late-stage clinical stage. Mark SawickiChief Scientific Officer at Cryoport00:26:57Yeah. Most of what we saw as it relates to that, those activities in 2022 and 2023 have already shaken out. If you followed our clinical trial activity over the last four to six quarters, we saw higher than average attrition of programs. That was the culling of nonproductive programs as well as the tightening of the clinical trial environment. That has been winding down over the last two quarters. I think you see that as evidenced by a strong increase in clinical trials supported in Q4, much higher than we've seen in the last eight quarters. Subbu NambiAnalyst at Guggenheim00:27:37Super helpful, guys. Thank you. Mark SawickiChief Scientific Officer at Cryoport00:27:39Thank you. Operator00:27:41Thank you. Your next question comes from the line of David Larsen from BTIG. Please go ahead. David LarsenManaging Director at BTIG00:27:48Hi. Congratulations on the good quarter. It looks like you're turning the corner here. Can you talk a little bit about the gross margin expansion? I think it was up over 500 basis points year over year in the quarter, both product and service. Was that more cost reduction efforts, or was it really top-line growth? Just any thoughts that would be helpful. Thank you. Robert StefanovichCFO at Cryoport00:28:10Yeah. No, absolutely. Look, I think a lot of it is related to the cost measures that we've implemented in the second half of the year. We've seen a significant improvement in the cost structure based on the actions that we have taken. That really has helped drive the gross margins to where they are yesterday, right? On the service side, we moved for Q4 to 46.2% from 40.8% last year and from the product side from 40.4% last year to 45.1% this year. Both on the service side as on the product side, we've seen a good bounce back of gross margins. Our targeted gross margins in the longer term are 55%. In that model, we're looking at about 30% adjusted EBITDA margin. Those are our targets. We're certainly going to continue to take the actions to drive gross margins. Robert StefanovichCFO at Cryoport00:29:07There's still some room on the cost side, but obviously, we do expect the revenue growth to contribute to the gross margin as well going forward. David LarsenManaging Director at BTIG00:29:17I guess without getting too specific, Robert, would you be expecting a mid 40% gross margin in 2025? Is this a good steady state, the Q4 results? Robert StefanovichCFO at Cryoport00:29:29Yeah. I think there's opportunity for increase throughout the year. I think if you look at the year of 2025 and the guidance we've given, we expect overall to see kind of sequential improvements in our financial metrics. I think there's still some upward mobility on the gross margins. At the same time, I also want to remind everyone we do have some new initiatives that just came online, like IntegriCell, where we brought up two facilities in Liège, Belgium, and in Houston, Texas. Obviously, there's always going to be a little bit of a drag on that margin until they start seeing more substantial revenue come through the door. I do expect there's some upward mobility on the margins over time. Jerrell SheltonCEO at Cryoport00:30:15David, we have not veered from our targets that we've talked about for years: 55% gross margin, 30% adjusted EBITDA. Those are fully in sight. We simply have the drag of some of these projects that we have underway. As they come online, as Robert just mentioned, they will unleash operating leverage, and that will help drive our gross margin up substantially and thereby our adjusted EBITDA. We are confident in our plan and in the way we're implementing it. The cost adjustments that we did were simply reprioritization, some cost management that required cutting where we could, and it's showing extraordinary results, and we intend for that to continue. David LarsenManaging Director at BTIG00:31:09Great. Just one more quick one for IntegriCell. Is that generating revenue right now in any sense for what the revenue contribution will be in fiscal 2025? Jerrell SheltonCEO at Cryoport00:31:19The short answer is. It is. Mark could comment on that. Mark SawickiChief Scientific Officer at Cryoport00:31:23Yeah. Yeah. The bottom line is, yes, we have signed our first contracts with the IntegriCell platform in Q4 and continue to sign contracts in this quarter. We will see some revenue contribution in Q1, although very modest. I do not anticipate significant contribution for 2025. We will start to see notable contribution in 2026. It just takes time because there is a lengthy audit validation process to onboard starting material manipulation as it relates to FDA regulatory considerations. It takes a little bit of time. We have signed our first contracts in that space, including some top five pharmas that have bought into the platform or will start to use it in their portfolio, which we are very excited about. David LarsenManaging Director at BTIG00:32:12That's great. For MVE, any comments on large freezer, small freezer, doers? I've heard the word stabilizing. Is it stabilizing across all three of those categories and large freezer in particular? Jerrell SheltonCEO at Cryoport00:32:25What you heard is order patterns are beginning to stabilize, and it cuts across the company. David LarsenManaging Director at BTIG00:32:31Okay. Thanks very much. I'll hop back on the queue. Jerrell SheltonCEO at Cryoport00:32:34Thank you. Operator00:32:34Thank you. Thank you. Your next question comes from the line of Richard Baldry from Roth Capital. Please go ahead. Richard BaldryAnalyst at Roth Capital00:32:43Thanks. On the IntegriCell side, can an existing clinical trial protocol be altered to adopt the IntegriCell, or do you think this will be strictly on sort of new clinical launches? Jerrell SheltonCEO at Cryoport00:32:59This is not an alteration. This is an improvement in process. It's a revolutionary improvement. Mark, you want to comment further? Mark SawickiChief Scientific Officer at Cryoport00:33:08Yeah. Obviously, it's being written into quite a few new programs that are starting, but it does not preclude the ability to transition. If they have an established cryopreservation paradigm that's written into their BLA, yes, they can transition that into our platform. They may have to do an addendum to that, but it is doable. In fact, we are seeing that type of activity as well. Richard BaldryAnalyst at Roth Capital00:33:32Okay. As commercial cell and gene therapy becomes more material to the overall business, can you talk about any underlying seasonality to that specific segment that we should be concerned about, whether strength or stronger quarters, weaker quarters, whether that's based on numbers of days, holidays, things like that that we should take into consideration? Jerrell SheltonCEO at Cryoport00:33:54Nothing out of the ordinary that we can comment on there. Mark SawickiChief Scientific Officer at Cryoport00:34:00Yeah. There's nothing specific from a seasonality standpoint. The only impact you'll ever see is facility shutdowns where most companies will do a shutdown for the manufacturing for a week or two a year, but they're all different based on company. It's impossible to predict those elements. Richard BaldryAnalyst at Roth Capital00:34:19Okay. It sounded like you're largely done the operating expense cuts and got a little bit ahead of your own plan in terms of how much was realized. We look forward, do you feel like you're in more of a sideways spending pattern until sort of the top line begins to come back up, or are there some things that come in early, whether it's the two new facilities launched that bring the overall spending up maybe earlier in the year and then sort of plateaus as the revenues come through to get you back to profitability? Thanks. Robert StefanovichCFO at Cryoport00:34:51Yeah. Rich, we'll have some CapEx expenditures related to the new facilities in California and in Paris. That's certainly the case. I think maybe two items. One, yeah, we don't expect any significant increase in OpEx. Two, as a CFO, I can say that there's always opportunity for additional review of how we do things and where we can potentially take additional cost actions. I do expect us to really continue to look at ways we can improve efficiency, ways we can reduce cost without changing the growth initiatives that we have. Yeah. Richard BaldryAnalyst at Roth Capital00:35:40Great. Thanks. Operator00:35:44Thank you. Your next question comes from the line of Kyle Crews from UBS. Please go ahead. Kyle CrewsAnalyst at UBS00:35:51Hey, thank you for taking the question. Taking a step back from cell and gene therapy and looking kind of at the broader market and the non-cell and gene therapy part of your services business, can you expect how you expect that market to evolve over next year? Jerrell SheltonCEO at Cryoport00:36:08Mark, do you want to take that? Mark SawickiChief Scientific Officer at Cryoport00:36:10Sure. Yeah. I mean, obviously, we support multiple verticals within life sciences. Cell and gene are focused, but we also do a lot in direct-to-patient. We do activity on different vaccine activities or other biopharma space. I expect to see those to grow, but nominally or modestly because the non-cell and gene market is a little bit softer, but we should still see some growth in that space. On the transportation side, I think we'll also see growth, continued growth as it relates to non-cell and gene pharmaceutical product distribution. That would just. Jerrell SheltonCEO at Cryoport00:36:55That would just add to growth, Mark, maybe in IVF as well. Mark SawickiChief Scientific Officer at Cryoport00:36:59Yeah. Yeah. Reproductive medicine, we continue to see and play a dominant role. We're making very good headway as it relates to expansion of our service platform, ex-U.S. I do think we'll see contribution from that this year in the reproductive medicine space and as well in the animal health space. We're seeing an acceleration of clinical trial activity for companion animal cell therapy products. We should anticipate seeing quite a few clinical trial starts in support of the animal health space for companion animal cell therapy in 2025. Kyle CrewsAnalyst at UBS00:37:43Great. Thank you. Jerrell SheltonCEO at Cryoport00:37:51Any more? Operator, are there more questions? Operator00:38:08Your next question comes from the line of Matt Stanton. Please go ahead. Matt StantonAnalyst at Jefferies00:38:14Hey, thanks. Maybe just to go back to the 2025 guide. Appreciate you guys obviously don't give color at the specific therapy line item, but just if we think about the commercial basket overall, trying to get a better feel. I think it was up 20% for the year, high 30s for the quarter. Kind of which of those two is better for that bucket for 2025? I think, Mark, historically, you've talked about maybe 30% plus type growth over the next few years. Is something in the 30% plus range fair for the commercial revenue bucket here in 2025? Thank you. Jerrell SheltonCEO at Cryoport00:38:48I think that's fair, Mark, but you want to comment on that, Father? Mark SawickiChief Scientific Officer at Cryoport00:38:52Yeah. I mean, I think we'll be stronger than 20%, which was this year from a growth standpoint with a number of new launches in the therapy expansions. I think getting into the mid 30% is probably a hair aggressive. So I think we'll probably be in the high 20% is my guess at this point in time based on what we're seeing. Matt StantonAnalyst at Jefferies00:39:14Super. Thank you. Mark SawickiChief Scientific Officer at Cryoport00:39:16Yep. Operator00:39:18Thank you. If there are no further questions at this time, I will now hand the call back to Mr. Jerrell Shelton for any closing remarks. Jerrell SheltonCEO at Cryoport00:39:27Thank you, Operator. Thank you all for your questions. I think we had some constructive discussions, and we appreciate your interest in Cryoport. We finished this year with solid fourth-quarter results that were consistent with our expectations, where the results reflect the continued growth of our life sciences business, which included the revenue growth we achieved from the support of commercial cell and gene therapy. For our life sciences product segment, we're seeing what appears to be a stabilization of orders, as we talked about in the question and answer period. We have said before, our life sciences product business is solid and continues to provide positive cash flow. Our results also show our significant progress in improving our business economics. Market conditions in 2024 were difficult, and we took actions to address this. Jerrell SheltonCEO at Cryoport00:40:23As a result, we're beginning to see the effects of these initiatives, most notably in our gross margin improvement. We continue to anticipate that these actions will guide us to a return to positive adjusted EBITDA during 2025. We thank you for joining us this afternoon, and we appreciate the conversation. We appreciate your continuing support and your interest in our company. We look forward to updating you on our progress again as we report the first quarter of our financial results at the next call. Thank you very much, and have a good evening. Operator00:40:58Thank you. That concludes our call for today. Thank you for participating. You may all disconnect.Read moreParticipantsExecutivesJerrell SheltonCEOMark SawickiChief Scientific OfficerRobert StefanovichCFOAnalystsRichard BaldryAnalyst at Roth CapitalDavid SaxonAnalyst at NeedhamThomas HeinzenVice President of Corporate Development and Investor Relations at CryoportTodd FromerManaging Partner at KCSA Strategic CommunicationsKyle CrewsAnalyst at UBSAnna SnopkowskiAnalyst at KeyBanc Capital MarketsDavid LarsenManaging Director at BTIGSubbu NambiAnalyst at GuggenheimMatt StantonAnalyst at JefferiesAnalyst at Morgan StanleyPuneet SoudaAnalyst at Leerink PartnersPowered by Earnings DocumentsSlide DeckPress Release(8-K)Annual report(10-K) CryoPort Earnings HeadlinesCryoport, Inc.: Cryoport Reports First Quarter 2026 Financial ResultsMay 5 at 12:56 PM | finanznachrichten.deCryoport, Inc. (CYRX) Q1 2026 Earnings Call TranscriptMay 5 at 2:02 AM | seekingalpha.comSpaceX IPO hides a much bigger storyThe SpaceX IPO could be the biggest in history at $1.75 trillion - but the real story isn't the IPO itself. Elon believes what Michael Robinson calls 'Project Unlimited' could unlock $100 trillion in potential growth. One little-known company sits at the center of it all, and most investors have no idea it exists. Position yourself before this company potentially hits the front page.May 6 at 1:00 AM | Weiss Ratings (Ad)Cryoport (CYRX) Q1 2026 Earnings TranscriptMay 4 at 8:08 PM | finance.yahoo.comCryoport, Inc. 2026 Q1 - Results - Earnings Call PresentationMay 4 at 5:30 PM | seekingalpha.comCryoport Reports First Quarter 2026 Financial ResultsMay 4 at 4:05 PM | prnewswire.comSee More CryoPort Headlines About CryoPortCryoPort (NASDAQ:CYRX) (NASDAQ: CYRX) is a global provider of temperature-controlled logistics solutions for the life sciences industry. The company specializes in cryogenic shipping for critical biological materials, supporting the development, clinical testing and commercialization of cell and gene therapies, biologics, vaccines and reproductive medicine. By offering end-to-end supply chain management, CryoPort helps ensure the integrity and viability of temperature-sensitive products from point of origin to destination. CryoPort’s product portfolio includes proprietary cryogenic dry shippers, advanced active and passive thermal packaging, and real-time data monitoring platforms. These solutions enable uninterrupted maintenance of ultra-low temperatures during transit, while providing customers with transparency and compliance documentation. In addition to specialized containers for liquid nitrogen-based shipments, CryoPort offers on-demand logistics services, temperature excursion management and supply chain optimization tools via its cloud-based CryoPortal platform. Leveraging a global network of logistics partners, CryoPort delivers services across North America, Europe, Asia-Pacific and Latin America. The company’s 24/7 operations and qualified service centers help streamline regulatory requirements and minimize risk for research institutions, pharmaceutical and biotechnology companies, contract research organizations and cell therapy manufacturers. CryoPort continues to expand its infrastructure and technology offerings to support the growing demand for advanced therapy supply chains worldwide.View CryoPort ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Just How Big a Problem Could Amazon’s Cash Burn Rate Be?BlackBerry Rewrites Its Own Operating SystemGrab Holdings Faces Hurdles, But Upside Potential Is Hard to IgnorePalantir Drops After a Blowout Q1—What Investors Should KnowShopify’s Valuation Crisis Creates Opportunity in 2026onsemi Stock Dips After Earnings: Why the Dip Is BuyableTSLA: 3 Reasons the Stock Could Hit $400 in May Upcoming Earnings Coinbase Global (5/7/2026)Airbnb (5/7/2026)Datadog (5/7/2026)Ferrovial (5/7/2026)Gilead Sciences (5/7/2026)Microchip Technology (5/7/2026)MercadoLibre (5/7/2026)Monster Beverage (5/7/2026)Canadian Natural Resources (5/7/2026)W.W. 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PresentationSkip to Participants Operator00:00:00Good afternoon and welcome to Cryoport's Fourth Quarter and Full Year 2024 Earnings Conference Call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. As a reminder, this call is being recorded. I will now turn the call over to your host, Mr. Todd Fromer from KCSA Strategic Communications. Please go ahead. Todd FromerManaging Partner at KCSA Strategic Communications00:00:31Thank 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. 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. Todd FromerManaging Partner at KCSA Strategic Communications00:01:14In 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 U.S. Securities and Exchange Commission, and those described from time to time in the other reports which we file with the U.S. 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. Jerrell SheltonCEO at Cryoport00:01:54Thank you, Todd. Good afternoon, ladies and gentlemen. Thank you for joining our Fourth Quarter and Full Year 2024 Earnings Call. 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 Fourth Quarter and Full Year 2024 and 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. Now, I will provide you with a brief update on our business, and then we'll take your questions. 2024 was a tough year for the life sciences. Jerrell SheltonCEO at Cryoport00:02:51The effects of macroeconomic conditions and market dynamics were felt throughout the year. We adapted to the challenges and concluded the year with solid results and total annual revenues of $228.4 million, which is in line with our expectations. Our life sciences service business continued its expansion with double-digit year-over-year growth in biostorage and bioservices revenue during both the fourth and the full year periods. For the full year 2024, our life sciences services business represented 67% of total revenue compared to approximately 62% last year. We saw considerable revenue growth for the support of commercial cell and gene therapies, which rose 37% and 20% for the fourth quarter and full year, respectively. Cryoport continues to expand its market share in the growing cell and gene therapy industry. Jerrell SheltonCEO at Cryoport00:03:55As of the year end, we supported a total of 701 clinical trials, a net increase of 26 clinical trials over last year, with 81 of these trials in phase III. This is a record number of total clinical trials supported by Cryoport, and it is indicative of the potential commercial revenue opportunity that is developing. Moreover, we also saw a record number of Cryoport-supported commercial approvals over the last year, increasing the number of commercial programs we support from 14 to 19. In our life sciences product business, we think our order patterns are beginning to show signs of stability. I would remind you that even with the downturn of the cryogenic systems market, our management team has continued to provide positive free cash flow from this business. Jerrell SheltonCEO at Cryoport00:04:51As previously reported, during 2024, we implemented a number of cost management initiatives in our product segment to align our operations with current global industry dynamics. As cost reduction and capital realignment strategies were implemented across our entire company, we made considerable progress in improving our gross margin. For the fourth quarter of 2024, our gross margin rose to 45.8% compared to 40.6% in the same period last year. We remain confident that these actions that have been taken are taking effect and will lead us to a return to positive adjusted EBITDA during 2025. At the same time, we have continued to advance our most important business development plans, which have been underway for some time, as we strive to balance those plans with our commitment to achieving positive adjusted EBITDA during 2025. We're confident that these undertakings will open up new revenue streams and move us forward. Jerrell SheltonCEO at Cryoport00:05:56For example, in the fourth quarter, we opened our IntegriCell Cryopreservation Solution with new state-of-the-art facilities located in Houston, Texas, and Liège, Belgium. IntegriCell was set up to produce high-quality standardized cryopreserved starting material for the manufacture of cell therapies. Based on market research and our first interactions with prospects and newly signed clients, we believe IntegriCell will generate significant revenue as it offers significant advantages to cell therapy manufacturers, allowing them to produce more consistent, more robust, standardized products more efficiently. IntegriCell addresses a critical aspect in optimizing the supply chain for the development and commercialization of cell-based therapies. Another example is our Cryoport Express Cryogenic CX HV3 Shipping System, or HV3, which was introduced in January of this year. The HV3 is a revolutionary cryogenic shipper that offers our clients enhanced payload production, storage efficiency, mobility, and accessibility. Jerrell SheltonCEO at Cryoport00:07:06With the introduction of HV3, we also improve patient accessibility to vital cell therapies in smaller cities and remote areas as it will fit into smaller aircraft. We believe this will benefit patient outcomes at large. Looking forward in 2025, we believe we are well positioned to further capitalize on the anticipated growth of the cell and gene therapy industry. At this time, we're projecting that 23 BLAs, or MMA filings, could occur in 2025, up from 11 last year. We're happy that 2025 is off to a good start as three filings have already occurred in January. Cryoport's huge base of clinical trials continues to push forward, and we expect to post another record amount of commercial revenue in 2025. Based on all this, we're providing full year 2025 revenue guidance in the range of $240 million-$250 million. Jerrell SheltonCEO at Cryoport00:08:09We intend to maintain our leading market positions, open up additional revenue streams, and unleash our operating leverage as market demand grows. We will complement this with seeking strategic collaborations throughout the year. We're confident that we have taken steps necessary to implement our growth plans and to reach our objectives of positive adjusted EBITDA during 2025. This concludes my prepared remarks, so now I'll ask the Operator to open the lines for your questions. Operator00:08:43Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your telephone keypad. You will hear a prompt that your hand has been raised, and should you wish to cancel the request, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Anna Snopkowski from KeyBanc Capital Markets. Please go ahead. Anna SnopkowskiAnalyst at KeyBanc Capital Markets00:09:17Hi, good afternoon. Thank you for taking my question. This is Anna on for Paul Knight. Maybe to start on the significant and impressive 37% increase in commercial revenue you saw in the fourth quarter, could you walk through some of the drivers there and whether this was broad-based or maybe one commercial therapy that drove this? Thank you. Jerrell SheltonCEO at Cryoport00:09:43I think Mark Sawicki can best answer that question. Mark SawickiChief Scientific Officer at Cryoport00:09:48Yeah, I'd be happy to answer that question. A couple of factors. Number one is it was a broad-based increase. It wasn't focused on one or two clients. Some of the key drivers here are we've seen the advancement of earlier line approvals with some of our commercial clients. We've seen additional companies get approved. We had five commercial approvals last year, and we're starting to see contribution with multiple of those programs as well, as well as our historical programs continue to expand on a geographic basis, as well as they're pushing for line extension into different therapy classes, and all of those have contributed to that strong Q4 performance. Anna SnopkowskiAnalyst at KeyBanc Capital Markets00:10:36That's helpful. Switching to the MVE side of the business, it seems like you saw some stabilization there in the fourth quarter. Do you feel confident that this will continue to stabilize or maybe even recover in 2025? Jerrell SheltonCEO at Cryoport00:10:54We are seeing the order patterns beginning to show some signs of stability at MVE, and we feel that that will continue throughout 2025. It may be uneven, but we think it will continue to progress. Anna SnopkowskiAnalyst at KeyBanc Capital Markets00:11:11Thank you. Operator00:11:12Thank you. Your next question comes from the line of Puneet from Leerink Partners. Please go ahead. Puneet SoudaAnalyst at Leerink Partners00:11:23Yeah, hi guys. Thanks for the questions. First one around the guide for 2025, can you elaborate your expectation for service versus product, and maybe what are the growth assumptions you have by logistics and also the CRYOGENE and the MVE business within the context of guide? Jerrell SheltonCEO at Cryoport00:11:45In the context of guidance, I think Robert will add to what I have to say, Puneet, and thank you for that question. Obviously, services will be a bigger portion of our guidance, and it will grow faster than life sciences products. With that, I'll turn it to Robert to elaborate more. Robert StefanovichCFO at Cryoport00:12:03Yeah, maybe just a few things to put it in context. We typically do not guide on business units directly. What I can say is if you look at the revenue growth in biostorage bioservices, which was double-digit, the bioservices growth, which was 7% year-over-year. In particular, on the cell and gene therapy side, the strong growth on the commercial therapy side, that obviously drives the services business growth. For products, we certainly have to take a more conservative view just based on the comments that Jerry had earlier on this call to really look at very modest increases in product revenue for guidance purposes. It is really driven by the services side. Puneet SoudaAnalyst at Leerink Partners00:12:52Okay. That's helpful. There is quite a bit of discussion on tariffs. Just wondering, is there any impact on the cost of the doors or freezers from any of the steel aluminum tariffs, Canada, Mexico, or otherwise? I'm just trying to understand. I'm sure you've thought through that. Are there any tariffs on the freezers from the China plant or anything that is getting serviced from the U.S.? Jerrell SheltonCEO at Cryoport00:13:25Yeah, we have thought through that. We do have, Puneet, and however tariffs impact us, and we can't tell for sure on all of them except the direct things that we hear about the tariffs on aluminum and stainless steel. We will pass on tariff impacts through surcharges for the period of time that they exist. We don't expect impact on our margin. Would you like to come in further, Robert? Robert StefanovichCFO at Cryoport00:13:57I think that covers it. I mean, I think what we have demonstrated even in the past with some of the supply chain issues that we've had in prior years that the management has been able to really maintain solid gross margins. I think we have quite good control over the cost structure and the ability to ensure that we maintain gross margins for the MVE, for the products business. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:14:25I'd just like to make one thing clear. This is Puneet. The freezers for the U.S. market are made in Ball Ground, Georgia. Jerrell SheltonCEO at Cryoport00:14:32Cryogenic freezers. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:14:33Cryogenic freezers. The cryogenic doors are also manufactured in Minnesota. There is no impact that way for our U.S. business. Puneet SoudaAnalyst at Leerink Partners00:14:42Got it. That's helpful. When I was looking at your clinical trial growth, just a last question on this. That appears to be about net clinical trial growth of about 6% in 2024. Wondering what's your expectation here for 2025? Any impact from NIH indirect cuts? A number of these trials get started in the academic setting in medical schools. Wondering if you're seeing any updates or impact that you're contemplating from any of those institutions. Thank you. Jerrell SheltonCEO at Cryoport00:15:23Puneet, I'll answer the last question first and then turn it to Mark for trial expectations. In terms of the NIH, we have very little exposure to the situation with the NIH. We are not directly concerned about that at this point. Mark, would you answer the second part? Mark SawickiChief Scientific Officer at Cryoport00:15:46Yeah, happy to. Yeah. As you can see with the data itself in Q4, Q4 was the best performance that we've had in, I would say, over the last eight quarters on new trial acquisition. I think that's a manifestation of the improvement in the overall cell and gene spaces as it relates to clinical trial activity. I do anticipate that we will see continued strong performance. I would expect that 2025 will be stronger than 2024 on a new trial acquisition basis. Robert StefanovichCFO at Cryoport00:16:21Puneet, as you'll see in the review document, there's another 23 possible filings in 2025. On the commercial side, there's a lot of activity as well. Three filed already in January. We expect another 10 possible approvals, of which five are new therapies. It's a very robust kind of pipeline of activities within the cell and gene therapy space. Puneet SoudaAnalyst at Leerink Partners00:16:46That's where I would. All right. Thank you. Operator00:16:51Thank you. Your next question comes from the line of Tejas Savant from Morgan Stanley. Please go ahead. Operator00:16:59Hi, this is Edmond on for Tejas. Thank you for the time. Switching back to MVE, can you guys elaborate a little bit more on what you guys are seeing from your customers across your geo regions in terms of seeing early signs of stability? Jerrell SheltonCEO at Cryoport00:17:16The signs of stability are in the order patterns, and that's a collective thing. So as far as I can actually go in answering that question, we see signs of stability. This doesn't say that everything is stable and rosy, but we are seeing those signs of stability that we like to see in that market. Jerrell SheltonCEO at Cryoport00:17:38Got it. Appreciating that your presence in China has gotten smaller over the past few years to about less than 3% of your total. Given the concerns on Chinese retaliations on tariffs, even if nothing has happened yet, to what degree are local substitutes available in the region? Do you continue to think that your in-China strategy is sufficient in securing a position in the market here? Jerrell SheltonCEO at Cryoport00:18:03Yeah. I mean, local sources in China certainly are available, and there are other sources throughout Asia. We are implementing our China-first China strategy as we speak, and we will unveil that later on. Robert StefanovichCFO at Cryoport00:18:23Yeah, and outside of China, again, this is where Tom mentioned. We have our manufacturing facilities here in the U.S. that manufacture the cryogenic freezers and doors for the U.S. market, for the European market. In some ways, we mitigate some of that risk that a lot of other companies have in the space with regards to China. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:18:44Maybe one last thing to add there, Ed, is that in our guide, there is no assumption of a recovery from China. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:18:57Got it. That's helpful. One last one for me. How are you guys thinking about revenue contributions from the five new therapies that were approved in 2024 for your 2025 guidance? With the recent layoffs at the FDA, are you starting to hear customers' concern about longer approval timelines for cell and gene therapies? Jerrell SheltonCEO at Cryoport00:19:17Mark, I don't know that we can give guidance on those five therapies, but I'll let you speak to that question. Mark SawickiChief Scientific Officer at Cryoport00:19:25No, you're absolutely right. We don't break out individual contribution, although we do anticipate that multiple of the new therapies that were launched in 2024 will contribute meaningful revenue to the commercial totals for 2025. That's about as far as I can delineate on that. Regarding the FDA, now, we do not anticipate the activities within the FDA from a governmental standpoint to have an impact on cycle time. In fact, we've seen very robust approval activity, and we continue to see progression there. I wouldn't anticipate a meaningful impact on the 2025 portfolio. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:20:07As a matter of fact, one of our customers today announced that their BLA received and have a PDUFA date in August. Things keep moving forward. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:20:20Great. Appreciate the time and the answers, guys. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:20:23Thank you. Operator00:20:26Thank you. Your next question comes from the line of David Saxon from Needham. Please go ahead. David SaxonAnalyst at Needham00:20:31Oh, great. Good afternoon. Congrats on the quarter, and thanks for taking my questions. Maybe I'll start with Robert just on profitability, the PR noticed or noted expectations for getting to profitability in 2025. Can you just help us around specificity? When might that be? Either by quarter, like first half, second half, and then kind of directional expectations for the year? Should we be thinking break even or any better or worse? And then I'll follow up. Robert StefanovichCFO at Cryoport00:21:06Yeah. Maybe just to frame it a little bit, when we talked about some of the cost measures that we took starting in Q2, we've made good progress. We implemented the majority of those activities, and that really drove that consistent improvement of adjusted EBITDA over the last three quarters, moving from a -$6.6 million to now a -$1.3 million for Q4. On an annualized basis, that equates to about $22 million. That is in line with what we were targeting, actually a little bit better than what we were targeting. We are, of course, focusing on expanding gross margins and driving profitable revenue growth. You have seen a significant enhancement of our gross margins year over year, both for the services revenue as well as for the product revenue. I think we're well on track to continue to execute. Robert StefanovichCFO at Cryoport00:22:00At the same time, we are driving certain initiatives that we have that we believe will drive revenue growth in the near future. That is another aspect to consider. I think in terms of timing of reaching adjusted EBITDA, positive adjusted EBITDA, we can't give you direct timing, but it is our stated goal to reach that during 2025. The timing of it really depends on some of the ramp that we expect to see on the services side, in particular on the cell and gene therapy side. David SaxonAnalyst at Needham00:22:35Okay. Okay. That was helpful. Thanks for that. I wanted to ask on MVE. You're noting order patterns are stable. The quarter was pretty strong at $20 million in dollar terms. Is that a good starting point against the backdrop of order patterns being stable? Is there any mixed dynamic that we should be aware of that would materially change kind of quarterly expectations? Thanks so much. Jerrell SheltonCEO at Cryoport00:23:09There's no mixed dynamic that we can point to right now. David SaxonAnalyst at Needham00:23:17Okay. Great. Thanks. Operator00:23:21Thank you. Your next question comes from the line of Subbu Nambi from Guggenheim. Please go ahead. Subbu NambiAnalyst at Guggenheim00:23:28Hey, guys. Thank you for taking my question. One question. Once a therapy is commercial, what are the drivers of revenue growth to Cryoport on that therapy? Is it just volume ramp for the therapy and indication of something? Or are there opportunities to increase your wallet share with the manufacturer? Mark SawickiChief Scientific Officer at Cryoport00:23:47We pursue both. Yeah. We pursue both avenues. Both ramp in volume from a patient's treated standpoint as well as revenue diversification. In many of the cases, we're seeing that both of those occur. Subbu NambiAnalyst at Guggenheim00:24:07Got it. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:24:08Thank you for asking that. Yeah, you see that in the Bioservices, Biostorage starting to grow. Hopefully, this year, as Mark will probably talk more later on, is that IntegriCell initiative. These are the projects that we've invested in for years that are now starting to get some traction. Subbu NambiAnalyst at Guggenheim00:24:29Thank you for that, guys. You did mention that you expect 2025 to be better, but what have you been seeing with respect to biopharma biotech funding in 2024? What trends are you expecting to see in 2025? Mark SawickiChief Scientific Officer at Cryoport00:24:44Yeah. I think it was $15.2 billion for all of 2024, which was the best year in a number of years. In fact, for cell and gene investment, 2025 is going to be a little bit more challenging from an expectation standpoint. I think it'll be a strong year, but we obviously have to see what happens with the federal government and what's happening there. I will couch that with just a caveat. The markets themselves are very positive. In fact, a lot of the activity that we were at from a trade show standpoint and from a market standpoint, the sentiment overall is much more positive than it has been in a long time. Not s``ure if Tom wants to add anything to that. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:25:28No, other than on our quarterly review document that is on our website, Subbu, when you have a chance to download it on page five, you will see the cell and gene therapy investments by year. It was a really good year in 2024. Jerrell SheltonCEO at Cryoport00:25:41Yep. Correct. Subbu NambiAnalyst at Guggenheim00:25:44Are you assuming the similar levels of funding for 2025 in your guide? Mark SawickiChief Scientific Officer at Cryoport00:25:52Yeah. I mean, we obviously, based on the sentiment that was expressed at some of the JPMorgan, Facilitate, and others, it looks like it'll be a year that we believe will be positive. I would expect, hopefully, that we'll see activity that's at par or even a little bit stronger than 2024. Thomas HeinzenVice President of Corporate Development and Investor Relations at Cryoport00:26:13Just to maybe clarify, Subbu, that when you think about our guide, especially when you think about our commercial revenue and how we're factoring that, that has nothing to do with funding. These are from large pharma or public companies that aren't dependent on money coming in the door for their commercial ramps. Subbu NambiAnalyst at Guggenheim00:26:35I was just asking that because many of the smaller biotech funding biotech companies saw some struggle during the 2022, 2023 phase. That is what I was hitting on, not so much. I completely understand you come more on the commercial and probably late-stage clinical stage. Mark SawickiChief Scientific Officer at Cryoport00:26:57Yeah. Most of what we saw as it relates to that, those activities in 2022 and 2023 have already shaken out. If you followed our clinical trial activity over the last four to six quarters, we saw higher than average attrition of programs. That was the culling of nonproductive programs as well as the tightening of the clinical trial environment. That has been winding down over the last two quarters. I think you see that as evidenced by a strong increase in clinical trials supported in Q4, much higher than we've seen in the last eight quarters. Subbu NambiAnalyst at Guggenheim00:27:37Super helpful, guys. Thank you. Mark SawickiChief Scientific Officer at Cryoport00:27:39Thank you. Operator00:27:41Thank you. Your next question comes from the line of David Larsen from BTIG. Please go ahead. David LarsenManaging Director at BTIG00:27:48Hi. Congratulations on the good quarter. It looks like you're turning the corner here. Can you talk a little bit about the gross margin expansion? I think it was up over 500 basis points year over year in the quarter, both product and service. Was that more cost reduction efforts, or was it really top-line growth? Just any thoughts that would be helpful. Thank you. Robert StefanovichCFO at Cryoport00:28:10Yeah. No, absolutely. Look, I think a lot of it is related to the cost measures that we've implemented in the second half of the year. We've seen a significant improvement in the cost structure based on the actions that we have taken. That really has helped drive the gross margins to where they are yesterday, right? On the service side, we moved for Q4 to 46.2% from 40.8% last year and from the product side from 40.4% last year to 45.1% this year. Both on the service side as on the product side, we've seen a good bounce back of gross margins. Our targeted gross margins in the longer term are 55%. In that model, we're looking at about 30% adjusted EBITDA margin. Those are our targets. We're certainly going to continue to take the actions to drive gross margins. Robert StefanovichCFO at Cryoport00:29:07There's still some room on the cost side, but obviously, we do expect the revenue growth to contribute to the gross margin as well going forward. David LarsenManaging Director at BTIG00:29:17I guess without getting too specific, Robert, would you be expecting a mid 40% gross margin in 2025? Is this a good steady state, the Q4 results? Robert StefanovichCFO at Cryoport00:29:29Yeah. I think there's opportunity for increase throughout the year. I think if you look at the year of 2025 and the guidance we've given, we expect overall to see kind of sequential improvements in our financial metrics. I think there's still some upward mobility on the gross margins. At the same time, I also want to remind everyone we do have some new initiatives that just came online, like IntegriCell, where we brought up two facilities in Liège, Belgium, and in Houston, Texas. Obviously, there's always going to be a little bit of a drag on that margin until they start seeing more substantial revenue come through the door. I do expect there's some upward mobility on the margins over time. Jerrell SheltonCEO at Cryoport00:30:15David, we have not veered from our targets that we've talked about for years: 55% gross margin, 30% adjusted EBITDA. Those are fully in sight. We simply have the drag of some of these projects that we have underway. As they come online, as Robert just mentioned, they will unleash operating leverage, and that will help drive our gross margin up substantially and thereby our adjusted EBITDA. We are confident in our plan and in the way we're implementing it. The cost adjustments that we did were simply reprioritization, some cost management that required cutting where we could, and it's showing extraordinary results, and we intend for that to continue. David LarsenManaging Director at BTIG00:31:09Great. Just one more quick one for IntegriCell. Is that generating revenue right now in any sense for what the revenue contribution will be in fiscal 2025? Jerrell SheltonCEO at Cryoport00:31:19The short answer is. It is. Mark could comment on that. Mark SawickiChief Scientific Officer at Cryoport00:31:23Yeah. Yeah. The bottom line is, yes, we have signed our first contracts with the IntegriCell platform in Q4 and continue to sign contracts in this quarter. We will see some revenue contribution in Q1, although very modest. I do not anticipate significant contribution for 2025. We will start to see notable contribution in 2026. It just takes time because there is a lengthy audit validation process to onboard starting material manipulation as it relates to FDA regulatory considerations. It takes a little bit of time. We have signed our first contracts in that space, including some top five pharmas that have bought into the platform or will start to use it in their portfolio, which we are very excited about. David LarsenManaging Director at BTIG00:32:12That's great. For MVE, any comments on large freezer, small freezer, doers? I've heard the word stabilizing. Is it stabilizing across all three of those categories and large freezer in particular? Jerrell SheltonCEO at Cryoport00:32:25What you heard is order patterns are beginning to stabilize, and it cuts across the company. David LarsenManaging Director at BTIG00:32:31Okay. Thanks very much. I'll hop back on the queue. Jerrell SheltonCEO at Cryoport00:32:34Thank you. Operator00:32:34Thank you. Thank you. Your next question comes from the line of Richard Baldry from Roth Capital. Please go ahead. Richard BaldryAnalyst at Roth Capital00:32:43Thanks. On the IntegriCell side, can an existing clinical trial protocol be altered to adopt the IntegriCell, or do you think this will be strictly on sort of new clinical launches? Jerrell SheltonCEO at Cryoport00:32:59This is not an alteration. This is an improvement in process. It's a revolutionary improvement. Mark, you want to comment further? Mark SawickiChief Scientific Officer at Cryoport00:33:08Yeah. Obviously, it's being written into quite a few new programs that are starting, but it does not preclude the ability to transition. If they have an established cryopreservation paradigm that's written into their BLA, yes, they can transition that into our platform. They may have to do an addendum to that, but it is doable. In fact, we are seeing that type of activity as well. Richard BaldryAnalyst at Roth Capital00:33:32Okay. As commercial cell and gene therapy becomes more material to the overall business, can you talk about any underlying seasonality to that specific segment that we should be concerned about, whether strength or stronger quarters, weaker quarters, whether that's based on numbers of days, holidays, things like that that we should take into consideration? Jerrell SheltonCEO at Cryoport00:33:54Nothing out of the ordinary that we can comment on there. Mark SawickiChief Scientific Officer at Cryoport00:34:00Yeah. There's nothing specific from a seasonality standpoint. The only impact you'll ever see is facility shutdowns where most companies will do a shutdown for the manufacturing for a week or two a year, but they're all different based on company. It's impossible to predict those elements. Richard BaldryAnalyst at Roth Capital00:34:19Okay. It sounded like you're largely done the operating expense cuts and got a little bit ahead of your own plan in terms of how much was realized. We look forward, do you feel like you're in more of a sideways spending pattern until sort of the top line begins to come back up, or are there some things that come in early, whether it's the two new facilities launched that bring the overall spending up maybe earlier in the year and then sort of plateaus as the revenues come through to get you back to profitability? Thanks. Robert StefanovichCFO at Cryoport00:34:51Yeah. Rich, we'll have some CapEx expenditures related to the new facilities in California and in Paris. That's certainly the case. I think maybe two items. One, yeah, we don't expect any significant increase in OpEx. Two, as a CFO, I can say that there's always opportunity for additional review of how we do things and where we can potentially take additional cost actions. I do expect us to really continue to look at ways we can improve efficiency, ways we can reduce cost without changing the growth initiatives that we have. Yeah. Richard BaldryAnalyst at Roth Capital00:35:40Great. Thanks. Operator00:35:44Thank you. Your next question comes from the line of Kyle Crews from UBS. Please go ahead. Kyle CrewsAnalyst at UBS00:35:51Hey, thank you for taking the question. Taking a step back from cell and gene therapy and looking kind of at the broader market and the non-cell and gene therapy part of your services business, can you expect how you expect that market to evolve over next year? Jerrell SheltonCEO at Cryoport00:36:08Mark, do you want to take that? Mark SawickiChief Scientific Officer at Cryoport00:36:10Sure. Yeah. I mean, obviously, we support multiple verticals within life sciences. Cell and gene are focused, but we also do a lot in direct-to-patient. We do activity on different vaccine activities or other biopharma space. I expect to see those to grow, but nominally or modestly because the non-cell and gene market is a little bit softer, but we should still see some growth in that space. On the transportation side, I think we'll also see growth, continued growth as it relates to non-cell and gene pharmaceutical product distribution. That would just. Jerrell SheltonCEO at Cryoport00:36:55That would just add to growth, Mark, maybe in IVF as well. Mark SawickiChief Scientific Officer at Cryoport00:36:59Yeah. Yeah. Reproductive medicine, we continue to see and play a dominant role. We're making very good headway as it relates to expansion of our service platform, ex-U.S. I do think we'll see contribution from that this year in the reproductive medicine space and as well in the animal health space. We're seeing an acceleration of clinical trial activity for companion animal cell therapy products. We should anticipate seeing quite a few clinical trial starts in support of the animal health space for companion animal cell therapy in 2025. Kyle CrewsAnalyst at UBS00:37:43Great. Thank you. Jerrell SheltonCEO at Cryoport00:37:51Any more? Operator, are there more questions? Operator00:38:08Your next question comes from the line of Matt Stanton. Please go ahead. Matt StantonAnalyst at Jefferies00:38:14Hey, thanks. Maybe just to go back to the 2025 guide. Appreciate you guys obviously don't give color at the specific therapy line item, but just if we think about the commercial basket overall, trying to get a better feel. I think it was up 20% for the year, high 30s for the quarter. Kind of which of those two is better for that bucket for 2025? I think, Mark, historically, you've talked about maybe 30% plus type growth over the next few years. Is something in the 30% plus range fair for the commercial revenue bucket here in 2025? Thank you. Jerrell SheltonCEO at Cryoport00:38:48I think that's fair, Mark, but you want to comment on that, Father? Mark SawickiChief Scientific Officer at Cryoport00:38:52Yeah. I mean, I think we'll be stronger than 20%, which was this year from a growth standpoint with a number of new launches in the therapy expansions. I think getting into the mid 30% is probably a hair aggressive. So I think we'll probably be in the high 20% is my guess at this point in time based on what we're seeing. Matt StantonAnalyst at Jefferies00:39:14Super. Thank you. Mark SawickiChief Scientific Officer at Cryoport00:39:16Yep. Operator00:39:18Thank you. If there are no further questions at this time, I will now hand the call back to Mr. Jerrell Shelton for any closing remarks. Jerrell SheltonCEO at Cryoport00:39:27Thank you, Operator. Thank you all for your questions. I think we had some constructive discussions, and we appreciate your interest in Cryoport. We finished this year with solid fourth-quarter results that were consistent with our expectations, where the results reflect the continued growth of our life sciences business, which included the revenue growth we achieved from the support of commercial cell and gene therapy. For our life sciences product segment, we're seeing what appears to be a stabilization of orders, as we talked about in the question and answer period. We have said before, our life sciences product business is solid and continues to provide positive cash flow. Our results also show our significant progress in improving our business economics. Market conditions in 2024 were difficult, and we took actions to address this. Jerrell SheltonCEO at Cryoport00:40:23As a result, we're beginning to see the effects of these initiatives, most notably in our gross margin improvement. We continue to anticipate that these actions will guide us to a return to positive adjusted EBITDA during 2025. We thank you for joining us this afternoon, and we appreciate the conversation. We appreciate your continuing support and your interest in our company. We look forward to updating you on our progress again as we report the first quarter of our financial results at the next call. Thank you very much, and have a good evening. Operator00:40:58Thank you. That concludes our call for today. Thank you for participating. You may all disconnect.Read moreParticipantsExecutivesJerrell SheltonCEOMark SawickiChief Scientific OfficerRobert StefanovichCFOAnalystsRichard BaldryAnalyst at Roth CapitalDavid SaxonAnalyst at NeedhamThomas HeinzenVice President of Corporate Development and Investor Relations at CryoportTodd FromerManaging Partner at KCSA Strategic CommunicationsKyle CrewsAnalyst at UBSAnna SnopkowskiAnalyst at KeyBanc Capital MarketsDavid LarsenManaging Director at BTIGSubbu NambiAnalyst at GuggenheimMatt StantonAnalyst at JefferiesAnalyst at Morgan StanleyPuneet SoudaAnalyst at Leerink PartnersPowered by