Q4 2025 Cryoport Inc Earnings Call

March 3, 2026

Speaker #1: Good afternoon and welcome to Cryoport's Fourth Quarter in full year 2025 earnings conference call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question-and-answer session.

Speaker #1: If at any time during this call you require a needed assistance, please press star 0 for the operator, as a reminder this call is being recorded.

Speaker #1: I will now turn the call over to your host, Todd Fromer from KCSA Strategic Communications. Please go ahead.

Speaker #2: Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events, or developments that we expect or anticipate occurring in the future are forward-looking statements.

Todd Frommer: Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and the information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, except as required by law.

Todd Fromer: Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and the information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, except as required by law.

Speaker #2: 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.

Speaker #2: 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, future events, or otherwise, except as required by law.

Speaker #2: 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.

Todd Frommer: In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors, and elsewhere in our annual report, our Form 10-K, we filed with the Securities and Exchange Commission, and those described from time to time in the other reports which we file with the Securities and Exchange Commission. As a reminder, Cryoport has uploaded their Q4 and full year 2025 in review documents to the main page of the Cryoport Inc. website. This document provides a review of Cryoport's financial and operational performance and the general business outlook.

Todd Fromer: In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors, and elsewhere in our annual report, our Form 10-K, we filed with the Securities and Exchange Commission, and those described from time to time in the other reports which we file with the Securities and Exchange Commission. As a reminder, Cryoport has uploaded their Q4 and full year 2025 in review documents to the main page of the Cryoport Inc. website. This document provides a review of Cryoport's financial and operational performance and the general business outlook.

Speaker #2: These risks and uncertainties include, but are not limited to, those described in item 1(a), 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.

Speaker #2: As a reminder, Cryoport has uploaded their fourth quarter and full year 2025 in review document to the main page of the Cryoport Inc website.

Speaker #2: This document provides a review of Cryoport's financial and operational performance and a general business outlook. Before I turn the call over to Jerry, please note that, because of the strategic partnership that has been established with DHL and the related sale of Cryo PDP to DHL, Cryo PDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment, are now presented as discontinued operations.

Todd Frommer: Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL and related sale of CRYOPDP to DHL, CRYOPDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment, are now presented as discontinued operations. Cryoport previously provided quarterly historical information on this basis for fiscal year 2024 in our Q1 2025 in review documents, which remains available on the Cryoport, Inc. website. This information is intended to support the financial model modeling efforts of those needing this type of information. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport's fiscal year 2025 regular revenue guidance. It's now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport.

Todd Fromer: Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL and related sale of CRYOPDP to DHL, CRYOPDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment, are now presented as discontinued operations. Cryoport previously provided quarterly historical information on this basis for fiscal year 2024 in our Q1 2025 in review documents, which remains available on the Cryoport, Inc. website. This information is intended to support the financial model modeling efforts of those needing this type of information. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport's fiscal year 2025 regular revenue guidance. It's now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport.

Speaker #2: Cryoport previously provided quarterly historical information on this basis from fiscal year 2024 and our first quarter 2025 in review document, which remains available on the Cryoport Inc website.

Speaker #2: This information is intended to support the financial modeling efforts of those needing this type of information. Please note that, unless otherwise indicated, all revenue figures discussed today will refer to continuing operations.

Speaker #2: This includes Cryoport's fiscal year 2025 revenue guidance. It is now my pleasure to turn the call over to Mr. Cheryl Shelton, Chief Executive Officer of Cryoport.

Speaker #2: Jerry, the floor is yours.

Todd Frommer: Jerry, the floor is yours.

Todd Fromer: Jerry, the floor is yours.

Speaker #3: Thank you, Todd. We have a great report for you today, ladies and gentlemen. But before we begin, 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.

Jerrell Shelton: Thank you, Todd. We have a great report for you today, ladies and gentlemen. Before we begin, with us this afternoon is our Chief Financial Officer, Robert Stefanovich, our Chief Scientific Officer, Dr. Mark Sawicki, and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. Today, we reported our full year results for 2025, which was a year of strong progress for Cryoport. We delivered full year revenue from continuing operations of $176.2 million, exceeding the high end of our prior guidance and reflecting continued momentum across our core markets. In Q4, we again achieved double-digit revenue growth driven by expanding commercial cell and gene therapy activity and revenue from the support of commercial cell and gene therapy, increasing 29% year-over-year to a record $33.4 million for the year.

Speaker #3: Today, we reported our full year results for 2025, which was a year of strong progress for Cryoport. We delivered full year revenue from continuing operations of $176.2 million, exceeding the high end of our prior guidance and reflecting continued momentum across our core markets.

Speaker #3: In the fourth quarter, we again achieved double-digit revenue growth, driven by expanding commercial cell and gene therapy activity, and revenue from the support of commercial cell and gene therapy increased 29% year over year to a record $33.4 million for the year.

Speaker #3: Commercial cell and gene therapy revenue in the fourth quarter represented 20% of our overall revenue while clinical trial revenue remained solid, growing 14% year over year to 47.1 million.

Jerrell Shelton: Commercial cell and gene therapy revenue in Q4 represented 20% of our overall revenue, while clinical trial revenue remains solid, growing 14% year-over-year to $47.1 million. We concluded 2025 supporting a record 760 clinical trials and 20 commercial therapies worldwide. Our clinical trial support showed a net increase of 59 over the previous year and represented approximately 70% of total trials for the cell and gene therapy industry. Looking ahead to 2026, based on the information that we have, we anticipate another 13 BLA or MAA application filings, including 2 of which have already been filed, 9 new therapy approvals and an additional 2 approvals for label or geographic expansion. In the near term, Cryoport has 3 customers that are anticipating new therapy approval decisions in March and April of this year.

Speaker #3: We concluded 2025 supporting a record $760 clinical trials and 20 commercial therapies worldwide. Our clinical trial support showed a net increase of 59% over the previous year, and represented approximately 70% of total trials for the cell and gene therapy industry.

Speaker #3: Looking ahead to 2026, based on the information that we have, we anticipate another 13 BLA or MMA application filings including two of which have already been filed.

Speaker #3: Nine new therapy approvals. And an additional two approvals for label or geographic expansion. In the near term, Cryoport has three customers that are anticipating new therapy approval decisions in March and April of this year.

Speaker #3: We believe our clinical trial pipeline is spring-loaded. With 86 clinical trials in Phase Three, and 361 clinical trials in Phase Two. Remember, most of the cell therapies that were approved today were from Phase Two.

Jerrell Shelton: We believe our clinical trial pipeline is spring-loaded with 86 clinical trials in phase 3 and 361 clinical trials in phase 2. Remember, most of the cell therapies that were approved today were from phase 2. In our opinion, this market-leading base will drive the growth of our commercial revenue in the near and the long term. We continue to execute on our mission of expanding services to the life sciences by broadening our revenue streams and capturing more revenue per client. For 2025, revenue from our Life Sciences Services segment increased 18% year-over-year, including 22% growth in biostorage bioservices revenue. Our performance reflects the expanding scale and scope of the clinical and commercial programs we support and the trust our customers place in our comprehensive end-to-end supply chain solutions.

Speaker #3: In our opinion, this market-leading base will drive the growth of our commercial revenue in the near and the long term. We continue to execute on our mission of expanding services to the life sciences by broadening our revenue streams and capturing more revenue per client.

Speaker #3: For 2025, revenue from our life sciences services segment increased 18% year over year. Including 22% growth in biostorage, bioservices revenue. Our performance reflects the expanding scale and scope of the clinical and commercial programs we support and the trust our customers place in our comprehensive end-to-end supply chain solutions.

Speaker #3: While our primary focus remains on accelerating revenue growth and strengthening our market position, we continue to enhance our operational discipline along across the organization as we advance on our pathway to profitability.

Jerrell Shelton: While our primary focus remains on accelerating revenue growth and strengthening our market position, we continue to enhance our operational discipline across the organization as we advance on our pathway to profitability. In 2025, our cost reduction initiatives contributed to our gross margin of 47%, accompanied by a $12 million year-over-year improvement in Adjusted EBITDA. With our progress to date, we anticipate achieving positive Adjusted EBITDA in the second half of 2026. Turning to our life sciences product segment, revenue grew 7% year-over-year in 2025. MVE Biological Solutions focused on execution and innovation. Continues to further enhance its position as the global leader in the production of high-quality cryogenic systems. Recently, MVE launched its integrated condition monitoring solutions for its dry vapor shippers.

Speaker #3: In 2025, our cost reduction initiatives contributed to our gross margin of 47%, accompanied by a $12 million year-over-year improvement in adjusted we anticipate achieving positive adjusted EBITDA in the second half of 2026.

Speaker #3: Turning to our life sciences product segment, revenue grew 7% year over year in 2025. MVE Biological Solutions focused on execution and innovation and continues to further enhance its position as the global leader in the production of high-quality cryogenic systems.

Speaker #3: Recently, MVE launched its integrated condition monitoring solutions for its dry vapor shippers. These novel condition monitoring solutions are integrated with each doer, combining MVE's trusted cryogenic systems with advanced real-time conditioning monitoring technology supplied by Tech4Med.

Jerrell Shelton: These novel condition monitoring solutions are integrated with each dewar, combining MVE's trusted cryogenic systems with advanced real-time conditioning monitoring technology supplied by Tec4med, another Cryoport company. This system communicates with MVE's new Cryoportal, a cloud-based data capture and shipment management system. More recently, MVE launched its MVE Fusion 800 Series, a revolutionary self-sustaining cryogenic freezer that can fit through a single door, which opens up substantial market opportunities. These revolutionary cryogenic freezers eliminate the need for continuous liquid nitrogen supply, delivering exceptional reliability, safety, and sustainability in a compact footprint that is designed for settings where there is limited space and no readily available sources of liquid nitrogen. At Cryoport Systems, we increased our internal investments to support the traction that we are seeing across our broad portfolio of cell and gene therapy clients.

Speaker #3: Another Cryoport company. This system communicates with MVE's new cryoverse. A cloud-based data capture and shipment management system. More recently, MVE launched its Fusion 800 series, a revolutionary self-sustaining cryogenic freezer that can fit through a single door which opens up substantial market opportunities.

Speaker #3: These revolutionary cryogenic freezers eliminate the need for continuous liquid nitrogen supply delivering exceptional reliability, safety, and sustainability in a compact footprint that is designed for settings where there is limited space and no readily available sources of liquid nitrogen.

Speaker #3: At Cryoport Systems, we increased our internal investments to support the traction that we are seeing across our broad portfolio of cell and gene therapy clients.

Speaker #3: These strategic investments include the completion of our global supply chain center in Paris, France, the expansion of our Belgian operations to accommodate a key commercial client, and continuing the build-out of a global supply chain center in Santa Ana, California, which consolidates three existing facilities into a single expanded campus.

Jerrell Shelton: These strategic investments include the completion of our global supply chain center in Paris, France, the expansion of our Belgian operations to accommodate a key commercial client, and continuing the build-out of a global supply chain center in Santa Ana, California, which consolidates three existing facilities into a single expanded campus and enhances our service capabilities. Of course, one topic of the day is AI. It is certainly a tool we are embracing. As a part of our overall digital strategy, we are actively leveraging generative AI to enhance internal workflows and day-to-day operations. Our focus is on enabling employees to use secure enterprise-approved generative AI tools to reduce manual tasks, accelerate execution, and improve accuracy and consistency of outcomes. These focused efforts emphasize practical adoption through education, hands-on support, and real production use cases tied directly to current business needs.

Speaker #3: And enhances our service capabilities. Of course, one topic of the day is AI. And it is certainly a tool we are embracing. As a part of our overall digital strategy, we are actively leveraging generative AI to enhance internal workflows and day-to-day operations.

Speaker #3: Our focus is on enabling employees to use secure enterprise-approved generative AI tools to reduce manual tasks accelerated execution and improve accuracy and consistency of outcomes.

Speaker #3: These focused efforts emphasize practical adoption through education, hands-on support, and real production use cases tied directly to current business needs. There's no doubt that AI is reshaping our business and will play a significant role in our future.

Jerrell Shelton: There's no doubt that AI is reshaping our business and will play a significant role in our future. In 2025, we reported a strategic partnership with DHL Group, which included DHL's acquisition of CRYOPDP. This action was completed in Q2 2025 and provided Cryoport with a substantial capital infusion. Over time, we expect this relationship to enhance our position in APAC and EMEIA regions and strengthen our competitive industry profile by leveraging the global scale and capabilities of this key strategic partner. As a part of our continuing strategic initiatives to embed our market-leading solutions in the cell and gene therapy ecosystem and improve our growth trajectory, we expanded our global partnerships by entering into strategic collaborations with Cardinal Health and Parexel. Both companies are leveraging Cryoport Systems' supply chain solutions in support of their complementary offerings in the cell and gene therapy space.

Speaker #3: In 2025, we reported a strategic partnership with the DHL Group, which included DHL's acquisition of CryoPDP. This action was completed in the second quarter of 2025 and provided Cryoport with a substantial capital infusion.

Speaker #3: Over time, we expect this relationship to enhance our position in APAC and EMEA regions and strengthen our competitive industry profile by leveraging the global scale and capabilities of this key strategic partner.

Speaker #3: As a part of our continuing strategic initiatives to embed our market-leading solutions in the cell and gene therapy ecosystem and improve our growth trajectory, we expanded our global partnerships by entering into strategic collaborations with Cardinal Health and Parexcel.

Speaker #3: Both companies are leveraging Cryoport system supply chain solutions in support of their complementary offerings in the cell and gene therapy space. These partnerships reinforce our position as a market leader in this space and the industry's drive to standardize.

Jerrell Shelton: These partnerships reinforce our position as a market leader in this space and the industry's drive to standardize. As we enter 2026 and consider global macro puts and takes, we believe that our full year revenue guidance of $190 million to $194 million is an appropriate starting point for the year. On a second point, we anticipate achieving positive Adjusted EBITDA in the second half of 2026.

Speaker #3: As we enter 2026 and consider global macro puts and takes, we believe that our full revenue guidance our full year revenue guidance of $190 million to $194 million is an appropriate starting point for the year.

Speaker #3: On a second point, we anticipate achieving positive adjusted EBITDA in the second half of 2026. There's a lot coming into focus for us. And we're very excited about our prospects for 2026 and intend to capitalize on our current momentum leadership position as the only pure-play temperature control supply chain integrated platform supporting the life sciences industry's largest portfolio of clinical and commercial cell and gene therapies.

Jerrell Shelton: There's a lot coming into focus for us, and we're very excited about our prospects for 2026 and intend to capitalize on our current momentum, leadership position as the only pure play, temperature control supply chain integrated platform supporting the life sciences industry's largest portfolio of clinical and commercial cell and gene therapies. This concludes my remarks. I now will turn the call over to the operator to open the lines for your questions and our discussion.

Speaker #3: This concludes my remarks. I will now turn the call over to the operator to open the lines for your questions and our discussion.

Speaker #1: Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press star followed by the number 1 on your touchstone phone.

Operator: Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press star followed by the number one on your touch tone phone. You will hear a prompt that your hand has been raised. If you'd like to withdraw from the polling process, please press star, then the number two. If you're using a speaker phone, please make sure to list your handset before pressing any keys. Your first question comes from the line of Puneet Sood from Leerink Partners. Please go ahead.

Speaker #1: You will hear a prompt that your hand has been raised. If you'd like to withdraw from the polling process, please press star, then the number 2.

Speaker #1: If you're using a speakerphone, please make sure to lift your handset before pressing any keys. Your first question comes from the line of Puneet Souda from Leerink Partners.

Speaker #1: Please go ahead.

Puneet Sood: Yeah. Hi, guys. Thanks for taking my questions here. First one, Jerry, or maybe for Robert, you know, the guide that you have, high single digit, nearly 9% at midpoint for the year, could you elaborate a bit more on that? In terms of the segments, how should we think about the growth in biologics or the services and the MVE? Given the commercial momentum, commercial therapy momentum that you're seeing, how should we think about that growth in, you know, for the full year? I have a follow-up.

Speaker #2: yeah, hi guys. thanks for, taking my questions here. So, first one, Jerry, or maybe for Robert. you know, the guide that you have, high single-digit, nearly 9% of midpoint for the year, could you elaborate a bit, bit more on that?

Speaker #2: And in terms of the segments, how should we think about the growth in biologics, and the services, and the MBE? And given the commercial momentum, commercial therapy momentum that you're seeing, how should we think about that growth for the full year?

Speaker #2: And I have a follow-up.

Speaker #3: Okay. So, so there are several questions, and, and that request, Puneet. So I'd like to, start to kind of, parse those questions. So, your question you know, the first one is how, how we feel about the, the it was your last point about how we feel about the growth of cell and gene therapy for, for 2026.

Jerrell Shelton: Okay. There are several questions in that request, Puneet. I'd like to start to kind of parse those questions. Your question, the first one is how we feel about it was your last point about how we feel about the growth of cell and gene therapy for 2026. Is that correct?

Speaker #3: Is that correct?

Speaker #2: Y-yeah. Well, on the commercial side, I mean, what's your growth expectation for commercial therapies? And then, also, if you can provide more color on the segments, each of the segments, the biologistics, the biostorage, and the MBE.

Puneet Sood: Yeah. Well, on the commercial side, I mean, what's your growth expectation for commercial therapies? Also, if you can provide more color on the segments, each of the segments, the biologistics, biostorage, and the MVE.

Speaker #3: Okay. So I'm gonna start with, with, with, with the last question first, and then I'm gonna turn it over to Mark. Okay? Because he, he has a he has a view on this.

Jerrell Shelton: Okay. I'm gonna start with the last question first, and I'm gonna turn it over to Mark, okay? Because he has a view on this. We do expect continued progress with our existing customers, and we do expect to be bringing on other commercial therapies during the year. It does take time for them to ramp up, but they will have some impact. Some of those that we've already brought on will have a continuing impact. Mark can name some of those names, perhaps, but, you know, we do try to avoid commenting directly on customers' business. In general, let me turn it over to Mark and let him answer the rest of that.

Speaker #3: But we do expect continued progress with our existing customers, and we do expect to be bringing on other commercial therapies during the year. It does take time for them to ramp up, but they will they will have some impact.

Speaker #3: And some of those that we've already brought on will have a continuing impact. And Mark can name some of those names, perhaps, but, but we, you know, we do try to avoid commenting directly on customers' business.

Speaker #3: So, so in general, let me turn it over to Mark and let him let him answer the rest of that.

Speaker #4: Yeah. So, Puneet, you know, obviously, we typically don't furnish guidance on composition by type. We did increase our commercial revenue by 29% in 2025.

Robert Stefanovich: Yeah. Puneet, you know, obviously, we typically don't furnish guidance on composition by type. We did increase our commercial revenue by 29% in 2025, and it's now eclipsing 20% of our overall revenue. You know, looking at 2026, you know, we do expect to have another good year in 2026, although we haven't disclosed the percentages associated with the commercial revenue at this point.

Speaker #4: And it's now eclipsing 20% of our overall revenue. You know, looking at '26, you know, we, we do expect to have a-another good year in '26, although we haven't disclosed the per the percentages associated with the commercial revenue at this point.

Speaker #3: And, and Puneet, there's no doubt about it that, commercial therapy will be the driver, of our future. I mean, it is the fastest-growing market.

Jerrell Shelton: Puneet, there's no doubt about it that commercial therapy will be the driver of our future. I mean, it is the fastest-growing market. As I mentioned, you know, earlier, we're forecasting 9 new therapies in 2026, and furthermore, we're forecasting 11 BLA/MAA filings to take place. As I mentioned in my comments, we think we're spring-loaded. We have 86 trials in phase three, and then we have that, I think it was 391 in phase two. We're spring-loaded for a brilliant future. You know, even if half of those in phase three are approved, it's a fantastic for us.

Speaker #3: And, as I mentioned, you know, earlier, we're forecasting nine new therapies in 2026, and we're f and we're for-furthermore, we're forecasting 11 BLA, MAA filings to, to take place.

Speaker #3: And, and as I mentioned in my comments, we think we're spring-loaded. We have 86 trials in phase three. And, and then we have, that, I think it was 391 in, in phase two.

Speaker #3: So we're, we're spring-loaded for a, a brilliant future. And I, I, you know, even if half of those in phase three are, are approved, it-it's fantastic for us.

Speaker #3: So.

Speaker #4: And maybe just to add to it, you know, we've grown in all of our service lines, and we've grown on our product side as well.

Robert Stefanovich: Maybe just to add to it, you know, we've grown in all of our service lines, and we've grown on our product side as well. We expect, you know, to continue to see growth really in all of our product lines and service lines. We always talk about services growing double-digit, obviously commercial therapy being the strong grower within that. Then on the product side, you know, single-digit growth, mid-single-digit growth, potentially high single-digit growth, depending on how the demand is coming back.

Speaker #4: We expect, you know, to continue to see growth really in all of our product lines and service lines. We always talk about services growing double-digit.

Speaker #4: Obviously, commercial therapy being, being the strong grower within that. and then on the product side, you know, single-digit growth, mid, mid-single-digit growth, potentially high single-digit growth depending on how the demand is coming back.

Speaker #3: So, on your second part of your question, Puneet—and if I've missed anything or we've missed anything, you can come back—but the second part of your question on biostorage, bioservices: biostorage, bioservices grew by 22%.

Jerrell Shelton: On your second part of your question, Puneet, and if I've missed anything or we've missed anything, you can come back. Second part of your question on biostorage bioservices. Biostorage bioservices grew by 22% for this past year. We're very pleased with that. It will continue to grow. In fact, we think it will pick up growth. I'm certain about that. It, of course, it is driven by cell therapy approval. It's a bright future for biostorage bioservices. The third part of your question-

Speaker #3: for this past year. We're very pleased with that. And, and it will continue to grow, in fact, we think it will pick up growth, I know I'm, I'm certain about that.

Speaker #3: And it, it of course, it is driven by cell therapy approvals. So, so, so you, it's, it's a bright future for biostorage, bioservices. The third part of your question.

Speaker #2: Got it. Mm-hmm. Please go.

Puneet Sood: Got it. Mm-hmm. Please go.

Jerrell Shelton: Go ahead, Puneet.

Speaker #3: Go ahead, Puneet.

Speaker #2: Yeah. On just the MBE segment too, I mean, you had 2% growth, I believe, in the quarter. And correct me if I'm wrong.

Puneet Sood: Yeah, just on the MVE segment, too. I mean, you had 2% growth, I believe, in the quarter, and correct me if I'm wrong, and how should we think about that?

Speaker #2: And how should we think about that?

Jerrell Shelton: We were up 7% for the year. MVE is doing well. I mean, it's got. You know, we try to create these fountains of innovation throughout the company to make sure that we're moving ahead. MVE has introduced its, you know, the integrated monitoring systems that I mentioned during my comments. Equally important are the things that will be introduced in this next quarter or in this quarter.

Speaker #3: we had yeah, we had we had we were up 7% for the year. And, and M-MBE, is do is doing well. I mean, it's, it's got you know, we, we try to create these fountains of innovation throughout the company so to make sure that we're moving ahead.

Speaker #3: MBE, has, introduced its, you know, the, the, integrated the integrated, monitoring systems that I mentioned, during my comments. But, but more import equally important are the things that will be introduced in this next quarter.

Speaker #3: Or in this quarter, as a matter of fact. So, and, and we've introduced the Cryoport. So you're gonna see MBE also adding some services to the product that it is producing.

Puneet Sood: Mm-hmm

Jerrell Shelton: ...as a matter of fact. We've introduced the Crowver. You're gonna see MVE also adding some services to the product

Mark Sawicki: That it's producing. Remember that Fusion 800 opens up a vast new market for us. I mean vast because there are many facilities on second floors in countries around the world that can't get a large freezer on that second floor that need a large cryogenic freezer. Hospital pharmacies will like this product as we move forward and as allogeneic therapies are developed.

Mark W. Sawicki, Ph.D.: That it's producing. Remember that Fusion 800 opens up a vast new market for us. I mean vast because there are many facilities on second floors in countries around the world that can't get a large freezer on that second floor that need a large cryogenic freezer. Hospital pharmacies will like this product as we move forward and as allogeneic therapies are developed.

Speaker #3: But remember that Fusion 800 opens up a vast new market for us. I mean, vast because there are many facilities on second floors, and countries around the world that can't get a large freezer on that second floor that need a large cryogenic freezer.

Speaker #3: hospital pharmacies will like this product as we move forward and as, allogeneic therapies are developed.

Speaker #5: Got it. super. And then just re quick clarification on, Q1. Any color you can provide there would be helpful. just and I wanted to know if there are any flight cancellations, disruptions from any of the geopolitical flight c cancellations that, you're expecting, in Q1.

Puneet Sood: Got it. Super. Just a quick clarification on Q1. Any color you can provide there would be helpful. Just, I wanted to know if there are any flight cancellations, disruptions from any of the geopolitical flight cancellations that you're expecting in Q1. Thank you.

Speaker #5: Thank you.

Speaker #3: There's nothing that we're expecting in terms of cancellations and, and today, there's been, minimal, impact on us. so, so nothing to report there at this time.

Mark Sawicki: There's nothing that we're expecting in terms of cancellations. Today there's been minimal impact on us. Nothing to report there at this time.

Mark W. Sawicki, Ph.D.: There's nothing that we're expecting in terms of cancellations. Today there's been minimal impact on us. Nothing to report there at this time.

Speaker #6: Yeah. Come on, Q1.

Puneet Sood: Got it. Color on Q1?

Speaker #5: Got it. And then color on Q1?

Speaker #6: Yeah. We've had a solid start to Q1. Puneet, we're not expecting a light one like some other life science companies are.

Robert Stefanovich: Yeah, we've had a solid start to Q1, Puneet. We're not expecting a light one like some other life science companies are.

Speaker #4: Right.

Speaker #5: Got it. All right, guys. Thank you.

Puneet Sood: Got it. All right, guys. Thank you.

Speaker #4: Thanks, Puneet.

Robert Stefanovich: Thanks, Puneet.

Speaker #3: Your next question comes from the line of Anas Nopogosi from TBank Capital Markets. Please go ahead.

Operator: Your next question comes from the line of Anna Gjitani from KeyBanc Capital Markets. Please go ahead.

Speaker #7: Hi. Thanks for taking my question. And congrats on a great quarter. and a nice guide for '26. so maybe to start, you mentioned in your prepared remarks that total biopharma funding, and CGT funding in particular saw the strongest funding month in December in the past four years, I believe.

Anna Gjitani: Hi, thanks for taking my question, and congrats on a great quarter, and a nice guide for 2026. Maybe to start, you mentioned in your prepared remarks that total biopharma funding, and CGT funding in particular, saw the strongest funding month in December in the past 4 years, I believe. I was wondering what the usual lag is between the funding environment and maybe your customer conversations or orders. A quick follow-up. Thank you.

Speaker #7: So I was wondering, what the usual lag is between the funding environment and, maybe your customer conversations or orders. And then a quick follow-up.

Speaker #7: Thank you.

Speaker #3: Yeah. Yeah. So, so obviously, funding is dependent on the client. But on average, you'll typically see that kick in after about a half a year, timeframe.

Robert Stefanovich: Yeah. Yeah. Obviously funding is dependent on the client, but on average, you'll typically see that kick in after about a half a year time frame. Some may be a little bit quicker, some may be a little bit slower, but it's a good average for you to consider.

Speaker #3: some, some may be a little bit quicker. Some may be a little bit slower. But it's a good it's a good average for you to consider.

Speaker #7: Okay. Perfect. and then maybe just touching on the margin side of things, you mentioned that you expect positive adjusted EBITDA, I think, in the second half of '26.

Anna Gjitani: Okay, perfect. Maybe just touching on the margin side of things, you mentioned that you expect positive Adjusted EBITDA, I think, in the second half of 2026. Could you just outline how you expect to get there, and what operational or cost reduction milestones need to happen in order to achieve this? Thank you.

Speaker #7: So could you just outline how you expect to get there? and what operational or cost reduction milestones need to happen in order to achieve this?

Speaker #7: Thank you.

Speaker #3: Yeah. It's, it's really less about, you know, cost reduction milestones. you may recall in, in '24, early '25, we did take some, some initiatives and, and, and operational initiatives to drive improvements.

Robert Stefanovich: Yeah, it's really less about, you know, cost reduction milestones. You may recall in 2024, early 2025, we did take some initiatives and operational initiatives to drive improvements, and that was, you know, quite successful where we improved Adjusted EBITDA about $12 million year-over-year. We are starting to invest in specific growth initiatives and completing some of the initiatives that we commenced in 2025 in setting up our global supply chain center in Paris and setting up our global supply chain center in California, which is going to consolidate three locations and expand our footprint there to include bioservices and IntegriCell. We also have a lot of insight with our client base. If you kind of step back and look at how we're positioned, it's really an unmatched positioning.

Speaker #3: And that was, you know, quite successful where we improved adjusted EBITDA by about $12 million, year over year. we are starting to invest in specific growth initiatives.

Speaker #3: and completing some of the initiatives that we commenced in 2025 in setting up our global supply chain center in Paris, and setting up our global supply chain center in California, which is going to consolidate three locations and expand our footprint there to include Bioservices and IntegraCell.

Speaker #3: We obviously have a lot of insight with our client base. If you kind of step back and look at how we're positioned, it's really an unmatched positioning.

Speaker #3: We, you know, serve about 70% of clinical trials, have a record 670 clinical trials, and we support 20 commercially approved therapies, for which a majority are cell therapies.

Robert Stefanovich: We, you know, serve about 70% of clinical trials, have a record 670 clinical trials, and we support 20 commercially approved therapies, for which a majority are cell therapies. So we have a lot of insight as to what's to come. We've been very successful in expanding our service offerings into bioservices, where we've seen strong growth. That expected growth, together with some of the efficiencies that we've identified, will really drive, you know, the further margin improvement.

Speaker #3: so we have a lot of insight as to what's to come. We've been very successful in expanding our service offerings into bioservices where we've seen strong growth.

Speaker #3: and so that expected growth, together with some of the efficiencies that we've identified, will really drive, you know, the, the further margin improvement.

Speaker #4: Yeah. I just wanna comment on the on the, the, the push out of the adjusted EBITDA, you know, positive numbers out of, out of the end of Q25.

Mark Sawicki: Yeah, I just want to comment on the push out of the Adjusted EBITDA, you know, positive numbers out of the end of Q 2025. Just want to, you know. One of the key elements here is that we've seen specific client requests to accelerate certain business opportunities. Our site in Belgium is a very good example of that, where we had to build out in a very rapid time frame, GMP compliant sterile kitting services for one of the very large volume commercial accounts. That is actually up and running, so we were able to do this in record time, commission the site in December, and it is now contributing revenue, which will ramp significantly over the next few years.

Mark W. Sawicki, Ph.D.: Yeah, I just want to comment on the push out of the Adjusted EBITDA, you know, positive numbers out of the end of Q 2025. Just want to, you know. One of the key elements here is that we've seen specific client requests to accelerate certain business opportunities. Our site in Belgium is a very good example of that, where we had to build out in a very rapid time frame, GMP compliant sterile kitting services for one of the very large volume commercial accounts. That is actually up and running, so we were able to do this in record time, commission the site in December, and it is now contributing revenue, which will ramp significantly over the next few years.

Speaker #4: Just wanna let you know, so one of the key elements here is that we've seen specific client requests to accelerate certain business opportunities. And so our site in Belgium is a very good example of that, where we had to build out, in a very rapid timeframe, a GMP-compliant sterile kitting service for one of the very large-volume commercial accounts.

Speaker #4: That has actually up and running. So we were able to do this in record time, commission the site in December. And it is now contributing revenue, which will ramp significantly over the next few years.

Speaker #4: So you know, w-we do still have to remain a little bit opportunistic on these types of opportunities. because they'll benefit the organization in the long term.

Mark Sawicki: You know, we do still have to remain a little bit opportunistic on these types of opportunities, because they'll benefit the organization in the long term.

Mark W. Sawicki, Ph.D.: You know, we do still have to remain a little bit opportunistic on these types of opportunities, because they'll benefit the organization in the long term.

Speaker #7: Got it. Thank you. And congrats again.

Anna Gjitani: Got it. Thank you, and congrats again.

Speaker #4: Thank you.

Robert Stefanovich: Thank you.

Speaker #6: Thanks, Anna.

Mark Sawicki: Thanks, Anna.

Mark W. Sawicki, Ph.D.: Thanks, Anna.

Speaker #3: Your next question comes from the line of Subhu Nambi from Guggenheim Securities. Please go ahead.

Operator: Your next question comes from the line of Subbu Nambi from Guggenheim Securities. Please go ahead.

Speaker #8: Hey, guys. Thank you for taking my question. within the 2026 guidance, can you speak to what you expect from the macro environment or, at the low end and the high end of your revenue guidance range?

Subbu Nambi: Hey, guys. Thank you for taking my question. Within the 2026 guidance, can you speak to what you expect from the macro environment or at the low end and the high end of your revenue guidance range?

Speaker #4: In terms of the macro I mean, obviously, if you look at the macro environment, it's, it's, it's quite volatile. if you if you look at specifically, you know, the markets that we're addressing, those have been progressing, very nicely, in spite of, you know, some of the challenges within the regulatory agencies.

Robert Stefanovich: In terms of macro, I mean, obviously, if you look at the macro environment, it's quite volatile. If you look at specifically, you know, the markets that we're addressing, those have been progressing very nicely in spite of, you know, some of the challenges within the regulatory agencies and the macro environment. You know, if you look at clinical trials, we had a record increase year-over-year in clinical trials, and we see, you know, a lot of interest for these services that we're providing. I think, you know, there's certainly an opportunity to beat the guidance that we're giving if we see some of the acceleration happening sooner. I think the downside risk is, you know, like really the same thing as for all other companies.

Speaker #4: And the macro environment, you know, if you look at clinical trials, we had a record increase year over year in clinical trials. and we see, you know, a lot of interest for these services that we're providing.

Speaker #4: So I think, you know, there's certainly an opportunity to beat, the, the, the guidance that we're giving. If we see some of the acceleration happening sooner, I, I think the downside risk is, you know, l really the same thing as for, for all other companies.

Speaker #4: You know, it's more of the unknown of what may happen. But we don't really have specific risks identified at this point in time.

Robert Stefanovich: You know, it's more of the unknown of what may happen. We don't really have specific risks identified, at this point in time, and we feel quite comfortable with the guidance that we're providing.

Speaker #4: And we feel quite comfortable with the guidance that we're providing.

Speaker #8: Thank you for that. And as a follow-up, you discussed the outlook for FDA approvals. But what is assumed in the guidance for animal health and reproductive health growth contributions?

David Brown: Thank you for that. As a follow-up, you discussed the outlook for FDA approvals, but what is assumed in the guidance for animal health and reproductive health growth contributions?

Robert Stefanovich: Thank you for that. As a follow-up, you discussed the outlook for FDA approvals, but what is assumed in the guidance for animal health and reproductive health growth contributions?

Speaker #4: Yeah. We, we don't typically disclose our, our segmentation, by, by product segment. so I'm not sure that's not something we typically outline. Yeah. It's, it's, it's, it's moderate growth.

Mark Sawicki: Yeah, we don't typically disclose our segmentation by product segment. I'm not sure. That's not something we typically outline.

Mark W. Sawicki, Ph.D.: Yeah, we don't typically disclose our segmentation by product segment. I'm not sure. That's not something we typically outline.

Jerrell Shelton: Yeah, it's moderate growth. I think the real growth drivers, you know, for us as a business is clearly the cell and gene therapy space on the services side. Within that, in terms of, you know, growth drivers, it's really further advancing the commercial cell therapies. You know, there's a number of activities, some happen in 2025. You know, the removal of the REMS requirement, which really started to see our clients accelerating their therapies into the outpatient setting. That's a significant move which portends to, you know, higher number of patients being treated, and that, again, translates into additional revenue to us.

Speaker #4: I think the real growth drivers, you know, for us as a business is clearly the cell and gene therapy space on the services of, you know, growth drivers, it's, it's really further advancing the commercial ther you know, cell therapies.

Speaker #4: You know, there's a number of activities—some happened in 2025. You know, the removal of the REMS requirement, which really started to, you know, we started to see our clients accelerating their therapies into the outpatient setting.

Speaker #4: and that's a, a significant move which pretends to, you know, hire a number of patients being treated. And, and that, again, translates into additional revenue to us.

Speaker #8: Thank you for the additional comment. Thank you, guys.

David Brown: Thank you for the additional color. Thank you, guys.

Jerrell Shelton: Thank you for the additional color. Thank you, guys.

Speaker #3: Your next question comes from the line of David Saxon from Needham. Please go ahead.

Operator: Your next question comes from the line of David Saxon from Needham & Company. Please go ahead.

Speaker #6: Great, good afternoon, guys. Thanks for taking my questions. Just two for me. One is to follow up on some of the comments earlier about product.

David Saxon: Great. Good afternoon, guys. Thanks for taking my questions. Just two for me. Wanted to follow up on some of the comments earlier about product growth. I think last quarter, you were kind of feeling good about high single digits for 2026. Sounds like you might be thinking more around mid-single digit growth for the year. Can you just give an update on, you know, MVE, the pipeline, the outlook there? Like, was there any incremental softening since last quarter, or is that just kind of conservatism baked in?

Speaker #6: growth, I think last quarter, you were, you were kind of feeling good about high single digits for '26. Sounds like you might be thinking more around mid-single digit growth for the year.

Speaker #6: So, can you just give an update on NDE, the pipeline, and the outlook there? Was there any incremental softening since last quarter?

Speaker #6: Is that just kind of conservatism baked in?

Speaker #4: And David, I, I, I think that, you know, we, we, we pretty much, a, a, addressed that. We thought that—we think our guidance is a good starting point for the year.

Jerrell Shelton: David, I, I think that, you know, we pretty much addressed that. We think our guidance is a good starting point for the year. There are a lot of macro risk out there, and we did assess those. Our starting point for our guidance is that $190 to $194, and we think it's a good starting point. MVE continues to work on a stabilized basis. It's got a great forecast, a budget for, you know, 2026, and it has innovation coming out of it on a constant basis now.

Speaker #4: There are a lot of macro risks out there, and we did assess those. And so our starting point for our guidance is that 190 to 194.

Speaker #4: And we think it's, we think it's a good starting point. MVE continues to work on a stabilized basis. It, it, it, it—it’s got a, it's got a great forecast, a budget for, you know, 2026.

Speaker #4: And, and it has innovation. coming out of it on a constant basis now. So, we think 20 MVE is in good condition. But we're, we're not forecasting growth, more than the, you know, house higher single digits, 7, 8 percent.

Jerrell Shelton: We think MVE is in good condition, but we're not forecasting growth, more than the, you know, higher single digits, 7% to 8%.

Speaker #6: Okay, that's super helpful. Thanks, Jerry. And then one I want to follow up on is some of the partnerships. Obviously, DHL—I guess, can you give an update there?

David Saxon: Okay. That's super helpful. Thanks, Jerry. Wanted to follow up on some of the partnerships. Obviously, DHL, I guess, can you give an update there? Like, is everything fully integrated and at a point where you can start to really see the benefits come through? You also mentioned Cardinal and Parexel. Can you just double-click there? Like-

Speaker #6: Like, is everything fully integrated and at a point where you can start to really see the benefits come through? And then you also mentioned Cardinal and Praxel.

Speaker #6: Can you just double-click there? Like, w—you know, frame those, and, and.

Jerrell Shelton: Yep.

David Saxon: You know, frame those.

Speaker #4: Yeah, yeah. DHL first. Look, DHL is a big, lumbering organization. And I—I've got—I want to go back to one of your points, your question a little bit earlier, your comment.

Jerrell Shelton: Yeah, let me talk about DHL first.

David Saxon: Yeah, great.

Jerrell Shelton: DHL is a lumbering, big lumbering organization. I wanna go back to one of your points, your question a little bit earlier, a comment, but after I talk about this. DHL is a large, very large organization, 600,000 employees spread all over the world. It takes time for them to mobilize and to. They can't operate as agilely as we do. It's gonna take time for that relationship. That's why I said the promise of in terms of EMEA and Asia Pacific and that impact. We are doing some things with them already, and we have some cooperative endeavors underway. For the full effect, it's gonna take a while for that to roll out.

Speaker #4: But, but after I talk about this. But DHL is, is, is a, a, a large, very large organization—600,000 employees—spread all over the world.

Speaker #4: It takes it takes time for them to mobilize and to and, and they don't act it they, they can't operate as an adj as agilely as we do.

Speaker #4: So it's gonna take time for that relationship. That's why I said the promise of, in terms of the me and AsiaPac and that impact.

Speaker #4: We are doing some things with them already. And, and we do we do have some cooperative endeavors underway. But to, to for the full effect, it's gonna take a while for that to roll out.

Jerrell Shelton: I'm gonna let Mark comment on Cardinal and Parexel. Before we do that, you were talking about MVE and the 7% growth and all that kind of stuff. I just want you to remember, the driver for this company is a commercialized cell and gene therapies. When that happens, that will dwarf MVE. MVE is a crucial part of our business. It's a foundational business. It's an important company, and it's healthy, and it has great cash flow. It has innovation. It's 70% of the market. It's the world leader. You know, it will not be as significant in terms of revenue proportionality in the future as it is today because cell and gene therapy will outgrow it.

Speaker #4: I'm gonna let Mark comment on Cardinal and Praxel. But before we do that, you, you were talking about MVE and the 7% growth and all that kind of stuff.

Speaker #4: Rem John, I just want you to remember the driver for this company is commercialization, commercialized cell and gene therapies. And, and that, and when that happens, that will dwarf MVE.

Speaker #4: MVE is a crucial part of our business. It's a foundational business. It's an important, it's an important company. And, and it's healthy. And it has great cash flow.

Speaker #4: It has innovation. It's 70% of the market. It's the world leader. But, you know, it, it is it will it will not be as significant in terms of revenue, proportionality, in the future as it is today because cell and gene therapy will outgrow it.

David Saxon: I just-

Speaker #4: And now Mark can comment on those partnerships we have with the other two, Praxel. Yeah. Yeah, so, you know, obviously what we're doing is focused on building out an ecosystem.

Jerrell Shelton: Now Mark can comment on those partnerships we have with the other two, Parexel and...

Mark Sawicki: Yeah. Yeah. You know, obviously, what we're doing is focused on building out an ecosystem that supports a cell and gene therapy global environment. One of the key elements of that strategy is to really define very strong partnerships with leading entities in the space that are complementary to what we do, but don't conflict with what we do. Parexel and Cardinal Health are two very good examples of that. You know, Parexel is a large CRO that really focuses on clinical trial design, FDA advisory services, and, you know, clinical engagement. Cardinal Health is obviously order to cash management, reimbursement, regulatory support, and then patient and provider support. Us working closely with them really allows our mutual client base to have a best-in-class product offering.

Mark W. Sawicki, Ph.D.: Yeah. Yeah. You know, obviously, what we're doing is focused on building out an ecosystem that supports a cell and gene therapy global environment. One of the key elements of that strategy is to really define very strong partnerships with leading entities in the space that are complementary to what we do, but don't conflict with what we do. Parexel and Cardinal Health are two very good examples of that. You know, Parexel is a large CRO that really focuses on clinical trial design, FDA advisory services, and, you know, clinical engagement. Cardinal Health is obviously order to cash management, reimbursement, regulatory support, and then patient and provider support. Us working closely with them really allows our mutual client base to have a best-in-class product offering.

Speaker #4: That supports the cell and gene therapy global environment. And one of the key elements of that strategy is to really define very strong partnerships with leading entities in the space that are complementary to what we do, but don't conflict with what we do.

Speaker #4: A-and Praxel and Cardinal Health are two very good examples of that. You know, so Praxel is a large CRO that really focuses on clinical trial design, FDA advisory services, and, you know, clinical engagement.

Speaker #4: A-and then Cardinal Health is obviously order-to-cash management, reimbursement, regulatory support, and then patient and provider support. A-and so us working closely with them, really, allows our our mutual client base to, to have a best-in-class product offering.

Speaker #4: And, you know, folks like Cardinal and Praxel have come to us because we are best-in-class from a supply chain services standpoint. These help drive the industry.

Mark Sawicki: You know, folks like Cardinal and Parexel have come to us because we are best in class from a supply chain services standpoint. These help drive the industry. So we're focused on long-term partnerships that help drive standardization and efficiency of the industry over time.

Mark W. Sawicki, Ph.D.: You know, folks like Cardinal and Parexel have come to us because we are best in class from a supply chain services standpoint. These help drive the industry. So we're focused on long-term partnerships that help drive standardization and efficiency of the industry over time.

Speaker #4: And so we're focused on long-term partnerships that help drive standardization and efficiency of the industry over time.

Speaker #6: Great. Thanks so much.

David Brown: Great. Thanks so much.

Mark W. Sawicki, Ph.D.: Great. Thanks so much.

Speaker #3: For additional questions, gentlemen, as a reminder, if you would like to ask a question, please press star followed by the number one on your touch-tone phone.

Operator: Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star followed by 1 on your touch-tone phone. If you are using a speakerphone, please make sure to lift your handset before pressing any keys. Your next question comes from the line of Mac McIntosh from Stephens. Please go ahead.

Speaker #3: And if you are using a speakerphone, please make sure to lift your handset before pressing any case. Your next question comes from the line of Macintosh from Stephens.

Speaker #3: Please go ahead.

Speaker #7: Hey, good afternoon, and thank you for taking my questions. Maybe just one for me. I think you highlighted in your prepared remarks that a large portion of these therapies are getting approved out of Phase II already.

Steven McLaurin Etoch: Hey, good afternoon, and thank you for taking my questions. Maybe just one for me. I think you highlighted on your prepared remarks that a large portion of these therapies are getting approved out of phase 2 already. With the FDA officially moving towards like a default one pivotal trial, how do you anticipate this change impacting approvals and investments over the near term? Thanks.

Stephen McLaurin Etoch: Hey, good afternoon, and thank you for taking my questions. Maybe just one for me. I think you highlighted on your prepared remarks that a large portion of these therapies are getting approved out of phase 2 already. With the FDA officially moving towards like a default one pivotal trial, how do you anticipate this change impacting approvals and investments over the near term? Thanks.

Speaker #7: And, with the FDA officially moving towards, like, a default one pivotal trial, how do you anticipate this change impacting approvals and investments over the near term?

Speaker #7: Thanks.

Speaker #4: Tom, why don’t you take that question?

Jerrell Shelton: Tom, why don't you take that question?

Robert Stefanovich: I was gonna let Mark do it.

Speaker #8: It's gonna let Mark do it.

Speaker #4: Yeah. Why don't you take it?

Jerrell Shelton: Yeah.

Speaker #8: All right. Any, anything that's gonna streamline the process, Mac, is a good thing. In our view, it's about more patients getting treated on the commercial side.

Robert Stefanovich: All right. Anything that's gonna streamline the process, Mac, is a good thing. In our view, it's about more patients getting treated on the commercial side. Commercial revenue is higher than clinical revenue 'cause there's typically more addressable patients for a commercial therapy than a clinical trial. I'll let Mark comment.

Speaker #8: Commercial revenue is higher than clinical revenue 'cause there's typically more addressable patients for a commercial therapy than a clinical trial. But I'll let Mark go find.

Speaker #4: Yeah, so, so obviously, yeah, I mean, if they follow through with a single pivotal and don't require a follow-up, that's beneficial to us.

Mark Sawicki: Obviously, I mean, if they follow through with a single pivotal and don't require follow-up, that's beneficial to us. If they come back and require additional follow-up, obviously that may slow things down. If you combine it with some of the other elements, in particular the REMS requirement changes, that's gonna be a huge driver for us 'cause that really allows us to push into the community care setting and our client base. If you recall, the vast majority of the addressable patient population is still in the community care setting, it provides a significant opportunity for upside on the already existing commercial products as well as the new ones that are coming to market.

Mark W. Sawicki, Ph.D.: Obviously, I mean, if they follow through with a single pivotal and don't require follow-up, that's beneficial to us. If they come back and require additional follow-up, obviously that may slow things down. If you combine it with some of the other elements, in particular the REMS requirement changes, that's gonna be a huge driver for us 'cause that really allows us to push into the community care setting and our client base. If you recall, the vast majority of the addressable patient population is still in the community care setting, it provides a significant opportunity for upside on the already existing commercial products as well as the new ones that are coming to market.

Speaker #4: If they come back and require additional follow-up, then obviously, that may slow things down. But if you combine it with some of the other elements, and particularly the REMS requirement changes, that's going to be a huge driver for us, 'cause that really allows us to push into the community care setting and our client base.

Speaker #4: And, and if you recall, the vast majority of, of the addressable patient population is still in the community care setting. And so it provides a significant opportunity for upside on the already existing commercial products, as well as the new ones that are coming to market.

Steven McLaurin Etoch: I appreciate it. I'll leave it there.

Stephen McLaurin Etoch: I appreciate it. I'll leave it there.

Speaker #7: I appreciate it. I'll leave it there.

Speaker #8: Thanks.

Robert Stefanovich: Thanks.

Speaker #3: For the last question, it comes from the line of David Larsen from BTIG. Please go ahead.

Operator: The last question comes from the line of David Larsen from BTIG. Please go ahead.

Speaker #9: Hi. congratulations on a good quarter. can you talk about the, MVE or product revenue growth in the fourth quarter? it looks like it was up 2% year over year for the year.

David Larsen: Hi, congratulations on a good quarter. Can you talk about the MVE or product revenue growth in Q4? It looks like it was up 2% year-over-year. For the year, it was up 7% year-over-year. It looks like it maybe slowed a little bit in Q4. Why was that, and what will sort of drive the re-acceleration in growth in 2026?

Speaker #9: It was up 7% year over year. So it looks like it maybe slowed a little bit in the fourth quarter. Why was that? And what will sort of drive the re-acceleration in growth in ’26?

Jerrell Shelton: David, you can't look at MVE systems on a quarterly basis and make too many judgments. I mean, the decisions for purchase of the capital equipment that MVE manufactures as cryogenic systems is planned over a period of time, and many times it's highly engineered in terms of the setting that it's going into the installation and its purpose. It's difficult to look at it. You're better off to look at an annual, an annual growth rate or a moving 12 months if you wanna look at it as moving 12 months. MVE is solid. It's a solid company, and the markets seem to be. We certainly are trying to help stabilize, you know, those markets.

Speaker #4: David, th-th thank you. You can't look at MVE systems on a quarterly basis and make too many judgments. I mean, the decisions for purchase of the capital equipment that MVE manufactures—that is, Cryogenic Systems—is planned over a period of time.

Speaker #4: And many times, it's highly engineered. In terms of the setting that it's going into, the installation and, and, and its purpose. So it-it's difficult to look at it.

Speaker #4: You're better off to look at an annual growth rate, or a moving 12 months, if you wanna look at it—moving 12 months.

Speaker #4: But MVE is solid. It's a solid company. And the markets seem to be—seem, and we certainly are trying to help stabilize, you know, those markets. And, you know, there's nothing, nothing, nothing more to add there, you know, other than if you have some comments, Robert.

Jerrell Shelton: You know, there's nothing more to add there, you know, other than if you have some comments, Robert, but I think that's the summary of.

Speaker #4: But I, I think that's, that's the summary of. Yeah. No, just if you if just to give you a maybe a little bit more granular picture of 2025, you know, when we looked at kind of the market growth and the MVE starting to come back and demand starting to come back, we've seen that both on both sides of the product portfolio, the, the Cryogenic Freezers, as well as the, the Cryogenic Transportation and, and Cryogenic Door portfolio.

Robert Stefanovich: Yeah. Just to give you, just to give you maybe a little bit more granular picture of 2025, you know, when we looked at kind of the market growth and the MVE starting to come back and demand starting to come back, we've seen that on both sides of the product portfolio, the cryogenic freezers as well as the cryogenic transportation and cryogenic dewar portfolio. From a regional perspective, as well, you know, in the various quarters, we've seen really all three regions at certain times, you know, starting to see a pickup in demand. Certainly it's a departure from what we've experienced in 2022, 2023. With that, you know, our guidance does, you know, assume some moderate, you know, mid-single digit type of growth rates for 2026.

Speaker #4: So, and then from a regional perspective as well, you know, in the various quarters, we've seen really all three regions at certain times, you know, starting to see a pickup in demand.

Speaker #4: so certainly, it's a departure from what we've experienced in, in '22, '23. And then with that, you know, our guidance does, you know, assume some moderate, you know, mid-single-digit type of growth rates for, for '26.

Speaker #9: And David, I want to remind you of one other thing. And this is just, just a matter of explanation, so that you're aware of it.

Jerrell Shelton: David, I wanna remind you of one other thing, and this is just a matter of explanation so that you're aware of it. I mean, MVE furnishes both Cryoport Systems and Cryogene with products, with cryogenic freezers and as well as dewars. The number you're seeing, the 7% for the year, for example, is a net number. It's, it doesn't include its sales internally. I just wanted you know, to point that out.

Speaker #9: I mean, MVE furnishes both Cryoport Systems and, Cry, Cryo, Cryogene, with products with, Cryogenic Freezers and as well as, Doors. The number you're seeing, the, the 7% for the year, for example, is a net number.

Speaker #9: It's, it's, it doesn't include its sales internally. but so I just wanted you y-you just wanted to point that out.

Speaker #3: Okay. And then, five years from now, what percentage of total revenue do you think could be coming from commercial?

David Larsen: Okay. five years from now, what percentage of total revenue do you think could be coming from commercial?

Speaker #4: You'll have to—we'll come back and, and, and, and, and, and, and talk with you about that. I, I, I can't tell you right offhand right now.

Jerrell Shelton: We'll come back and talk with you about that. I can't tell you right offhand right now. You know, I don't have a forecast for that. There's too many uncertainties right now for five years out. Five years is a long time in this business.

Speaker #4: and, you know, we don't we don't I don't have a forecast for that. There's too many uncertainties right now, for a for a five years out.

Speaker #4: Five years is a long time. And this business.

Speaker #9: Yeah. Well, well, we do model everything out, right? So I, you know, but as, as the, the timeframe goes out, there's more uncertainties that creep into the modeling in particular around the timing of new product launches and their adoption to the market.

Mark Sawicki: Yeah. We do model everything out, right? You know, but as the timeframe goes out, there's more uncertainties that creep into the modeling, in particular around the timing of new product launches and their adoption to the market. There's been products where, you know, the consensus from a market standpoint was, you know, this would be a very high growth, high traction product, and it disappointed or vice versa. There've been a couple of sleeper surprises where folks didn't anticipate much out of the product, and then it came in a lot stronger than anticipated. The key here to think about is again, the portfolio effect, right?

Mark W. Sawicki, Ph.D.: Yeah. We do model everything out, right? You know, but as the timeframe goes out, there's more uncertainties that creep into the modeling, in particular around the timing of new product launches and their adoption to the market. There's been products where, you know, the consensus from a market standpoint was, you know, this would be a very high growth, high traction product, and it disappointed or vice versa. There've been a couple of sleeper surprises where folks didn't anticipate much out of the product, and then it came in a lot stronger than anticipated. The key here to think about is again, the portfolio effect, right?

Speaker #9: There's been products where, you know, the mar the, the, the consensus from a market standpoint was, you know, this would be a very high-growth, high-traction product.

Speaker #9: And it disappointed, or vice versa. There've been a couple of sleeper surprises where folks didn't anticipate much out of the product, and then it came in a lot stronger than anticipated.

Speaker #9: The key here to think about is, is, again, the portfolio effect, right? And so our focus is around is around c-con you know, capturing the plurality of the clinical market and then holding it through commercial activity and a commercial launch.

Mark Sawicki: Our focus is around, you know, capturing the plurality of the clinical market and then holding it through commercial activity in a commercial launch. You know, we're currently supporting 20 commercial products. You know, you've seen the positive benefit over the last 12 months of that commercial portfolio, you know, where our commercial revenue has been extremely strong from a growth standpoint. We have a very strong prognosis on portfolio clients. You know, we've already talked about, you know, the potential of another 9 approvals this year, as well as additional geographic and market expansions. You know, as you look out further, that continues to expand out.

Mark W. Sawicki, Ph.D.: Our focus is around, you know, capturing the plurality of the clinical market and then holding it through commercial activity in a commercial launch. You know, we're currently supporting 20 commercial products. You know, you've seen the positive benefit over the last 12 months of that commercial portfolio, you know, where our commercial revenue has been extremely strong from a growth standpoint. We have a very strong prognosis on portfolio clients. You know, we've already talked about, you know, the potential of another 9 approvals this year, as well as additional geographic and market expansions. You know, as you look out further, that continues to expand out.

Speaker #9: you know, so we're currently supporting 20 commercial products. You know, you've seen the positive benefit over the last 12 months of that commercial portfolio.

Speaker #9: you know, where, where our commercial revenue, has been extremely strong from a growth standpoint. and we have a very strong prognosis on portfolio clients.

Speaker #9: You know, we've already talked about the potential of another nine approvals this year, as well as additional geographic and market expansions.

Speaker #9: you know, as you look out further, that, that, that continues to, to expand out. And if you're looking at the support mechanism of those, you know, o-of a phase two and phase three programs, a significant percentage of those will have a decision from a regulatory standpoint over the next three to four years, which will which will really impact, th-those numbers fairly dramatically, assuming that we, we get a, a reasonable return on commercial approvals.

Mark Sawicki: If you're looking at the support mechanism of those, you know, of our phase 2 and phase 3 programs, a significant percentage of those will have a decision from a regulatory standpoint over the next 3 to 4 years, which will really impact those numbers fairly dramatically, assuming that we get a reasonable return on commercial approvals. Then you have to also look at, obviously the impact of the REMS and the community care engagement, which is gonna be a huge factor as it relates to what that growth rate looks like.

Mark W. Sawicki, Ph.D.: If you're looking at the support mechanism of those, you know, of our phase 2 and phase 3 programs, a significant percentage of those will have a decision from a regulatory standpoint over the next 3 to 4 years, which will really impact those numbers fairly dramatically, assuming that we get a reasonable return on commercial approvals. Then you have to also look at, obviously the impact of the REMS and the community care engagement, which is gonna be a huge factor as it relates to what that growth rate looks like.

Speaker #9: And then you have to also look at, obviously, the impact of the REMS and the community care engagement, which is gonna be a huge factor as it relates to what that growth rate looks like.

Speaker #9: If our partners are successful in driving into the community care setting, and, you know, the leader on that is really Johnson Carvicti product, where, you know, they've published data that shows that they're, they're, you know, they're in the mid-30s now on a community care engagement standpoint.

Mark Sawicki: If our partners are successful in driving into the community care setting, and, you know, and the leader on that is really Janssen Carvykti product, where, you know, they've published data that shows that they're, you know, they're in the mid-thirties now on a community care engagement standpoint. You know, if they push that up to 50%, 60%, 70% and you have others that are doing the same, that's gonna have a significant material impact, not only in the existing commercial products, but the new ones coming to market.

Mark W. Sawicki, Ph.D.: If our partners are successful in driving into the community care setting, and, you know, and the leader on that is really Janssen Carvykti product, where, you know, they've published data that shows that they're, you know, they're in the mid-thirties now on a community care engagement standpoint. You know, if they push that up to 50%, 60%, 70% and you have others that are doing the same, that's gonna have a significant material impact, not only in the existing commercial products, but the new ones coming to market.

Speaker #9: You know, if they push that up to 50%, 60%, 70% and you have others that are doing the same, that's going to have a significant material impact not only in the existing commercial products but the new ones coming to market.

Speaker #9: And David, you know, just a couple of other comments. I mean, while, you know, b-b to, you know, add to what Mark is saying, I think you, you, you you can undoubtedly you can u-undoubtedly say that in the future in the future, that we, that, that Cell and Gene Therapy commercial Cell and Gene Therapy revenues will be the dominant factor.

Jerrell Shelton: David, just a couple of other comments. I mean, while to add to what Mark is saying, I think you can undoubtedly say that in the future that we that cell and gene therapy, commercial cell and gene therapy revenues will be the dominant factor. It'll be the dominant factor in our revenue. It'll be by far, and because it drives not only the biologistics, it drives the biostorage bioservices. You saw in this last quarter, I think it was a quarter, we grew about 23%.

Speaker #9: It'll be the dominant factor in our revenue. It'll, it'll be by, by far. and, and because it, it drives not only the biologistics, it drives it drives the, biosteroid biostorage, bioservices.

Speaker #9: You saw in this last quarter, I think it was a quarter, that we grew about 20, 20, 23 percent. And what you're gonna see over time is, you're gonna see as Cell and Gene Therapy picks up.

Jerrell Shelton: What you're gonna see over time is you're gonna see as cell and gene therapy picks up, that is the commercial therapy approvals happen, you're gonna see our growth rate, you know, come more in line with the growth of the industry. Because we, you know, the, the lower growth segments, which are foundational to what we do, you know, will be of a less of a proportion. It's an interesting question. We don't have a specific answer, but we directionally, we know where we're going. You had something else to add, Mark?

Speaker #9: That is, the commercial therapy approvals happen. You're gonna see our growth rate of, you know, m-m come more in line with the growth of the industry b-because we you know, the, the, the, the lowing the lower growth segments, which are foundational to what we do, you know, will be will be of a less, less of a proportion.

Speaker #9: So, it-it's an interesting question. I just don't—we don't have a specific answer, but directionally, we know where we're going. You had something else to add, Mark?

Speaker #4: Yeah. I just wanna you know, I just wanna point out i-if you go to slide six in our in our, presentation deck, that'll give you some market data that should give you, a reasonable understanding of the opportunity associated with, with the our commercial portfolio at this point.

Mark Sawicki: Yeah, I just wanna, you know, I just wanna point out, if you go to slide six in our presentation deck, that'll give you some market data that should give you a reasonable understanding of the opportunity associated with our commercial portfolio at this point.

Mark W. Sawicki, Ph.D.: Yeah, I just wanna, you know, I just wanna point out, if you go to slide six in our presentation deck, that'll give you some market data that should give you a reasonable understanding of the opportunity associated with our commercial portfolio at this point.

Speaker #3: Thanks very much.

David Brown: Thanks very much.

Mark W. Sawicki, Ph.D.: Thanks very much.

Speaker #4: Thank you.

Mark Sawicki: Thank you.

Mark W. Sawicki, Ph.D.: Thank you.

Speaker #1: There are no further questions at this time, so I'm going to turn the call back to the management team for closing comments. Please go ahead.

Operator: There are no further questions at this time, so I'm going to turn the call back to the management team for closing comments. Please go ahead.

Speaker #9: Okay. One second. Was it oh, was it prepared for that? okay. Well, thank you, you know, for your questions. Very good questions. And, and, and good discussion.

Jerrell Shelton: Okay, one second. Wasn't, I wasn't prepared for that. Okay. Well, thank you know, for your questions. Very good questions and good discussion, and we appreciate those questions. In summary, we made some significant strides in 2025 with solid results showing full year revenue performance above guidance. Our Life Sciences Services business segment grew 18% year-over-year, including 22% increase in biostorage bioservices revenue, and a 29% increase in revenue from commercial cell and gene therapy we support. We concluded 2025 supporting a record 760 clinical trials and 20 commercially approved cell and gene therapies worldwide.

Speaker #9: And we appreciate those questions. so in summary, we made some significant strides in 2025 with solid results showing full-year revenue performance above guidance. Our life science services business segment grew 18% year over year, including 22% increase in biostorage, bioservices revenue, and a 29% increase in revenue from commercial Cell and Gene Therapy we support.

Speaker #9: We concluded 2025 supporting a record $760 clinical trials and 20 commercial approved commercially approved Cell and Gene Therapies worldwide of the 760 clinical trials we support.

Jerrell Shelton: Of the 760 clinical trials we support, 86 are in phase 3 and 361 in phase 2, creating what we believe is a spring-loaded position to future commercial cell and gene therapy revenue streams. In addition to our financial performance, we continue to advance targeted strategic initiatives, which are designed to strengthen our growth trajectory in 2026 and beyond. Based on our market position and industry insights, we are encouraged by the opportunities ahead, we will continue to keep you updated on our progress. Thank you for joining us on today's call. We appreciate your continued interest and support and look forward to speaking with you again when we report our Q1 financial results for 2026. We wish you all a good evening. Operator?

Speaker #9: Eighty-six are in phase three, and 361 are in phase two, creating what we believe is a spring-loaded position for future commercial Cell and Gene Therapy revenue streams.

Speaker #9: In addition to our financial performance, we continue to advance targeted strategic initiatives, which are designed to strengthen our growth trajectory in 2026 and beyond.

Speaker #9: Based on our market position and industry insights, we are encouraged by the opportunities ahead and we will continue to keep you updated on our progress.

Speaker #9: Thank you for joining us on today's call. We appreciate your continued interest and support, and look forward to speaking with you again when we report our first quarter financial results.

Speaker #9: For 2026, we wish you all a good evening, operator.

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

Q4 2025 Cryoport Inc Earnings Call

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