Good afternoon, and welcome to Cryoport, Inc.'s first quarter 2026 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 0 for the operator. As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Fromer from KCSA Strategic Communications. Please go ahead.

Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events, or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on 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. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A Risk Factors and elsewhere in our Annual Report on Form 10-Ks to be filed with the Securities and Exchange Commission and those described from time to time in the other reports which we file with the Securities and Exchange Commission. As a reminder, Cryoport, Inc. has uploaded their first quarter 2026 in review document to the main page of the Cryoport, Inc. website. This document provides a review of Cryoport, Inc.'s financial and operational performance and the general business outlook. Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL Group, and the related sale of Cryo PDP to DHL in June 2025, Cryo PDP's financials, which were previously a part of Cryoport, Inc.'s Life Sciences Services reportable segment, are now presented as discontinued operations. Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport, Inc.'s fiscal year 2026 revenue guidance. It is now my pleasure to turn the call over to Mr. Jerrell W. Shelton, Chief Executive Officer of Cryoport, Inc. Jerry, the floor is yours.

Thank you, Todd, and good afternoon, ladies and gentlemen. With me today is our Chief Financial Officer, Robert S. Stefanovich; our Chief Scientific Officer, Mark W. Sawicki; and our Vice President of Corporate Development and Investor Relations, Thomas J. Heinzen. Our first quarter results continue to demonstrate our market-leading position, as revenue was $47.8 million, up 16% year over year, which puts us off to a very strong start for the year. This growth is a combination of our momentum over the past several quarters across our integrated services and products platform. Revenue in support of our commercial cell and gene therapy grew 26% to $9.1 million, while revenue from clinical trials grew 18% to $12.9 million. We continue to support one of the industry's broadest cell and gene therapy pipelines, and our leadership across both commercial and clinical programs positions us well for future sustainable growth. As of March 31, we supported a record total of 766 global clinical trials, a net increase of 55 clinical trials over the prior year, with 91 of these clinical trials in Phase III. From this market-leading base, we believe we will continue to drive robust growth in our commercial revenue in both the near and the longer term. During the first quarter, I am happy to report that our client, Rocket Pharmaceutical, received an accelerated approval from the FDA for their gene therapy, Crislotti. With this approval, the number of commercial therapies we are supporting has increased to 21. For the remainder of 2026, based on current information, we expect another 10 BLA or MAA application filings and up to eight additional new therapy approvals. Our Life Sciences Services segment delivered a strong quarter, with revenue increasing 18% year over year, including 21% growth in biostorage/bioservices. This performance reflects increasing adoption of our full-service portfolio in conjunction with the increasing scope and complexity of the cell therapy programs we support. It also underscores the critical role we play in supporting our clients with our extensive array of integrated temperature-controlled supply chain services and solutions. Our Life Sciences Products segment also performed well, generating 15% revenue growth driven by global demand for MVE Biological Solutions cryogenic systems. For over 60 years, MVE has provided high-quality, reliable cryogenic systems to the market, and every day it continues to further reinforce its position as the global leader. For example, during the first quarter, MVE introduced its new Fusion 800 series, which is a self-sustaining cryogenic freezer that eliminates the need for a continuous liquid nitrogen supply feed, delivering exceptional reliability, safety, and sustainability in a compact footprint designed for space-constrained environments where a source of liquid nitrogen is not readily available. This is quite an accomplished engineering feat, which will pay dividends for years to come as we open up new markets that were heretofore inaccessible. Growth across both our reporting segments—Life Sciences Services and Life Sciences Products—combined with solid gross margins and continued operational discipline, drove a $2.2 million year-over-year improvement in adjusted EBITDA from continuing operations, advancing us meaningfully along our pathway to profitability. We also reached a milestone moment during the first quarter as our IntegraCell team shipped its first cryopreserved clinical trial patient materials from both our Houston, Texas, and Liège, Belgium, facilities for two separate clients. This achievement highlights IntegraCell's progress as it continues to develop and moves us a step further toward being a meaningful contributor to the cell and gene therapy industry and to Cryoport, Inc.'s future revenue and profitability. In parallel, we continued to advance our digital and information strategy, including initiatives in digitization and generative AI to support complex internal workflows and improve our effectiveness and efficiency in day-to-day operations. Our focus is currently on enabling employees to use secure, enterprise-approved generative AI tools to automate repetitive tasks, analyze data in real time, manage risk, and accelerate decision-making and execution. We are already seeing tangible benefits and believe AI will play an increasingly important role in our future. Reflecting on our strong performance for the first quarter and our increased visibility into the remainder of the year, we are raising our full-year 2026 revenue guidance to $192 million to $196 million. We continue to review our guidance on a quarterly basis and we will make any further adjustments as warranted. We also believe that, based on our progress year to date, we will achieve positive adjusted EBITDA in the second half of this year. This concludes my prepared remarks. We will now open the call for questions.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. You will hear a prompt that your hand has been raised, and should you wish to cancel your 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 Puneet Souda from Leerink Partners. Please go ahead.

You had a $3 million beat versus the consensus, but you are raising the guide by $1 million. How much of that is prudence being early in the year? Any other considerations? And how should we think about 2Q, if you can provide some context there, given the momentum you are seeing in the business versus core clinical trials?

Thank you for the question, Puneet. We think that Q1 was an outstanding quarter, but we think it is a responsible guide given the continued uncertainty on a global macroeconomic basis. We will continue to evaluate this on a quarterly basis and adjust the guidance if warranted.

Maybe switching gears to MVE Life Sciences Products. You had 15% growth against an easier comp. How should we think about growth for Life Sciences Products overall with the new product introduction this year? Wondering if Robert can comment on that too.

Robert can comment on it, but I will start. All products in life sciences take time to ramp up, whether it is products or facilities. It will take time for those products to ramp up in the marketplace and to have any kind of an impact. We do think the markets are solid and have solidified, and we see continued indications that support that. We think that we will have a high single-digit growth market going forward. We may exceed that from time to time, but that is our assessment. Robert, you may want to add some things there.

The outperformance during Q1 was really driven by strong demand across all geographies and solid performance, particularly in animal health, but also life sciences overall. MVE is the number one leader in the market worldwide. We already saw stability in 2025 in terms of the return of product demand for cryogenic systems, and we continue to see that improvement as demonstrated in our Q1 performance.

We have seen improvement in biotech funding in the fourth quarter that has continued so far in the first quarter. Are you seeing higher momentum from that for RFP or contract volumes in the first quarter or the second quarter so far? Your net clinical trial adds were only six, but are you seeing momentum from customers given the funding environment?

Mark will take that.

Happy to. We are seeing definitive continued investment into Phase II and Phase III programs. If you take a look at our numbers, the Phase II data itself and Phase III data are increasing very nicely. Phase III was up five trials sequentially, which is very unusual, and we have not seen that in a long time. Year over year, Phase II is up almost 30 programs. A lot of that money is going into pushing these late-stage clinical assets over the finish line. We do see very positive signs from that.

To add to it, it is less about the number of increases in clinical trials. It is really looking at the 706 clinical trials we are supporting. That is a very strong number. As Mark mentioned, the maturation of those trials moving into Phase II and Phase III is key. You will remember that the majority of cell therapies approved to date went directly from Phase II to commercial launch, conducting their Phase III in parallel. You really have to look at the ongoing Phase II clinical trials and the 91 Phase III as potential for commercial launches.

That is super helpful. Congrats on the quarter.

Thank you.

Your next question comes from the line of Anna Snopkowski from KeyBanc Capital Partners. Please go ahead.

Thanks for taking my question, and congrats on a great quarter. You mentioned you shipped your first clinical trial patient material for IntegraCell, which is very exciting. Could you walk us through your initial learnings from this rollout and what your expectations are for IntegraCell in 2026?

We are really pleased that we are now supporting actual clinical processes in both locations—the site in Belgium and the site in Houston. It is a very nice achievement and something we have been working toward for a long period of time. IntegraCell, as an organization and as an asset, is going to be a very important driver for long-term revenue and margin expansion. It is a long cycle time for onboarding. It typically takes 12 to 18 months in some cases to onboard. We have active projects ongoing and additional clients coming on board now. Our overall outlook is extremely positive. From a learning standpoint, it has been extremely well received. One of the key elements is the fully integrated platform—our fully integrated service platform includes biologics and bioservices—and our initial clients are using all of our competencies. That is very important for our team as we harmonize and optimize those processes to really drive efficiency for our clients.

On the EBITDA side, could you walk us through some of the assumptions to get to second-half positivity? It seems like there are some facilities ramping that should help, and then also the commercial therapies mix. Any variables and areas of upside would be helpful.

If you look at our Q1 performance, we were very close to breakeven on the adjusted EBITDA side, with a negative $600 thousand. We reiterate reaching positive adjusted EBITDA in the second half of the year. This is driven by the revenue growth we see. You mentioned some of the initiatives and investments we have; those are really going to drive operating leverage in 2027. The achievements for Q2 of this year are driven by current organic revenue growth. The new facilities are investments we began in 2025 and are completing now in 2026. They are going to drive further enhancement of our profitability and adjusted EBITDA in 2026 and beyond.

Your next question comes from the line of David Joshua Saxon from Needham. Please go ahead.

Good afternoon, everyone. Thanks for taking my questions, and congrats on the strong start to the year. In the script this quarter and last quarter, you talked about AI initiatives that are helping reduce OpEx. How durable is that and can it be applied to more of the business, or are we seeing the full extent of the savings potential?

All of our AI initiatives are durable, and they are focused internally to enhance our efficiency and effectiveness. It is a very powerful tool that will reshape our business over time. We are excited about our AI initiatives, but they are focused today on practicality—improving efficiency and effectiveness in internal operations.

My second one might be for Robert. On the supply chain centers in Paris and Santa Ana, both in the second half, what is baked into guidance from those two coming online? When could we start seeing customer audits of those facilities? Anything from a gross margin perspective we should be aware of?

These initiatives we started in 2025 are being completed this year. The Paris, France site went operational with biologics in November, so that is already starting to ramp and clients are doing their audits. We will complement that with bioservices in Q3 of this year. The second is the Santa Ana, California site, which gives us a significant West Coast presence. It consolidates three of our existing locations into one and expands to about 94 thousand square feet to offer biologics, bioservices, consulting, testing, and ultimately space for IntegraCell. These are significant initiatives driven by client demand. From a guidance perspective, the revenue contribution is smaller because they come online in the second half. Clients will conduct their audits this year, and they will start contributing more significantly in 2027.

Anything on gross margin from that, or just generally how to think about gross margin?

What we mentioned at year-end still applies, albeit we came in higher on services gross margins than initially expected. We expected gross margins in the first half to have some pressure and to start rebounding in the second half. We did not really see that pressure in Q1, but margins should come back more significantly in the second quarter and second half of this year.

Your next question comes from the line of Analyst from Guggenheim, on behalf of Subhalaxmi Nambi. Please go ahead.

Hi. This is Ricky on for Subbu. Thanks for taking our question. The commercial cell and gene therapy revenue grew 26% year over year in the first quarter. Is that the right growth rate to think about for the year, or should we expect more acceleration as newer approvals ramp? Is the growth concentrated in a few key therapies like Carvykti, or is it broad-based across your supported commercial products?

On commercial revenues, research reports on the market range on the low end 20% and on the high end 40%. You are right—we saw solid revenue growth on the commercial side. We do expect that 2026 will be a very good year for commercial revenue. Our revenue guidance is really based on the existing commercial therapies that we are supporting. While there may be some revenue contribution from new approvals, the guidance is based on the existing platform we have for 2026.

Bristol Myers and J&J have already reported, and they reported a strong Q1. We cannot really talk about the rest of our commercial therapies we support because they have not reported their quarters yet.

Your next question comes from the line of David Michael Larsen from BTIG. Please go ahead.

Congratulations on the great quarter. Sticking with commercial products, how many commercial products are you supporting now, and did I hear you say that you could have potentially eight more launch within the next 12 months?

We are supporting 21 today, and yes, there are eight potential approvals of new therapies this year. Five of them already have PDUFA dates set by the FDA.

Can you talk about the dynamics of a commercial product you are supporting versus a clinical trial product? Is there a difference in margins or revenue per product? On the commercial side, since they are in the market being used, I would think there would be much more revenue potential per product because it is being used across the world for patients and not limited to one specific clinical trial. Any color on the revenue potential and margin relative to clinical trials?

A couple of things related to commercial therapies. One, as we support clinical trials, we then work with their commercial team in preparing for the launch of the commercial therapies, whether in one country or globally. We are part of the launch and provide program management that is billed separately as well. The increase in commercial revenues is driven by the patient population. As more commercial therapies come to market and move from teaching hospitals to regional or outpatient settings, the acceleration of patients being treated occurs, which drives more revenue. We are continuously expanding our service platform—initially biologics, adding bioservices, and ultimately IntegraCell cryopreservation services—which further expands revenue on a per-patient basis as we provide services along the supply chain of the cell and gene therapy market.

Your revenue growth this quarter versus two years ago is a huge positive. What do you attribute the resurgence in growth to? Is it simply the cell and gene therapy market coming back after working through the IRA?

It is a number of things. We have broadened our revenue stream; bioservices, which is a newer offering, increased over the last couple of quarters—20% plus year over year—and we expect that to continue. On the product side, we saw in 2025 demand normalizing and coming back. Across our different revenue streams, we are seeing stronger demand, and that has been driving revenue, which led us to increase the guidance for the full year.

Your next question comes from the line of Richard Baldry from Roth Capital. Please go ahead.

On the commercial acceleration, has it been concentrated around the CAR-T area with the regulatory burden easing, or is that still a catalyst ahead that has not really had an impact yet?

Cell therapies are the majority of our commercial customers. Gene therapies have had a slower start, but cell therapies are pulling the wagon—Bristol Myers, Gilead, J&J. Looking at our clinical trial portfolio, close to 90% of the clinical trials we are supporting are autologous and allogeneic cell therapies.

Your next question comes from the line of Analyst from Craig-Hallum Capital Group. Please go ahead.

Nice start to the year. Regarding the Fusion 800 series, could you talk a little bit about the pipeline? You mentioned positive response and some early adoptions, but what does that pipeline look like?

It is early to comment on the pipeline. We sell through distributors, and the first thing we do is get our 800 series into distribution. We are moving out very nicely, but it is too early to comment on the pipeline.

Switching gears, we are approaching a year since the REMS was removed. There was a lot of build-up as patients moved out of hospitals to ambulatory and other centers. Has that momentum continued? Are you seeing that opportunity expand beyond the core hospital setting? What can that mean for growth later this year and into next year?

Tom, you may want to comment on that.

If you look at companies that have reported—J&J and Bristol—outpatient and community hospital growth is helping to drive their revenue, which in turn helps to drive ours.

Your next question comes from the line of Analyst from Stephens. Please go ahead.

Good afternoon, and thank you for taking my questions. Following up on margins, MVE product margins were relatively light compared to our expectations. What are you seeing in terms of the storage industry in general and how are energy prices factoring into performance in the quarter and expected to factor into the remainder of the year?

Energy prices did not factor into the quarter for our products business. The margin variance is purely a result of specific product mix. Year over year, margins are pretty close. Sequentially it is down, but that is related to product mix we typically see in the first quarter. There is no pricing erosion or competitive element; it is product mix related.

It has been about six months since funding really started to tick back up. As you look at how the quarter is shaping up to date, what can you tell us about the level of activity and sentiment within your customer base today?

Overall, it is very good for the industry, especially for companies in need of raising funds to drive their clinical trial portfolio. Many clients we serve are very well established and funded, especially given the large number of Phase II and Phase III programs that are close to the finish line pre-commercial. We do not see a huge risk on the funding side there. It is mostly smaller companies in need of funding. It is certainly good for the industry to see funding coming back, with strong funding especially in April.

To peek under the hood with our clinical trial count, it increased by six net sequentially. There were 29 new trial adds in the quarter and 23 removed—net six. Of those 23 removed, 16 of the trials were completed. That is a great thing that shows the maturation of our pipeline. That means ones are going to go to twos, and twos are going to go to threes.

Your next question comes from the line of Matthew Jay Stanton from Jefferies. Please go ahead.

Robert, to close the loop on margins, given inflationary pressures over the last few months on commodities and logistics, can you remind us of your pricing structure? I believe you are able to pass along an uptick as part of the contracts you have in place. Can you remind us of the mechanics on pricing as it relates to inflationary pressure coming back into the P&L for the rest of the year?

In transportation and logistics—the component of our solution—fuel surcharges are normal. They may go up or down, but they are passed on to our client base. That is common practice, so it does not impact our gross margins. From a product side, we have not seen an impact from increased oil prices at this point, but we are keeping an eye on it like everyone else.

On the product side, I think, Jerry, you said that market could grow high singles. I think prior you thought products could be mid-singles for the year, maybe high singles if things came back better. After a strong Q1, do you feel like products is more like a high single-digit business in 2026 than mid-singles?

I do feel like it is high single-digit growth. It seems like it is solidifying across the globe, so I have no reason to think differently.

Maybe one for Mark to go back to IntegraCell. Now that customers at those two sites have started to move product, any finer point you can share on the volume or size of product you expect there? I know it takes a while to get things validated and started, but now that they are started, how meaningful could that be as IntegraCell ramps up? I think prior you had been bullish on the revenue opportunity given the number of products and services as part of IntegraCell.

We are bullish about everything we do. Since we formed the company, we have set standards in the industry. IntegraCell is another example of our industry-leading movement forward based on what the markets need and conversations with clients. IntegraCell is off to a good start. We would always like to have a more robust start, no matter what it is, but it is gaining a lot of attention. It does take time for these things to take hold, for other clients to come in, and for our integrated services approach to take effect. Stay tuned. As Mark said, it will unquestionably be a very important contributor to Cryoport, Inc. in the future.

There are no further questions at this time. I will now hand the call back to Mr. Shelton for any closing remarks.

Thank you, operator. Ladies and gentlemen, thank you for your questions and our discussions. In closing, I would like to remind you that we continue to be the market leader, and we have had a great start to 2026, marked by 16% revenue growth year over year and strong double-digit growth across both our reporting segments. Our Life Sciences Services revenue increased 18% year over year, driven by 21% growth in biostorage/bioservices revenue; a 26% increase in revenue from commercial cell and gene therapy support; and clinical trial–related revenue growth of 18%. At the same time, our Life Sciences Products revenue grew 15%, driven by global demand for MVE's cryogenic systems. Remember, MVE is the world leader in cryogenic systems. Our top-line growth was accompanied by solid gross margins, contained operating expenses, and continued operational discipline, which resulted in a $2.2 million year-over-year improvement in adjusted EBITDA from continuing operations, pushing us further down our pathway to profitability. Based on these results and the progress we have made with our strategic initiatives, we are more positive on our outlook for the year than when we last spoke on our year-end earnings call, and that led us to raise our full-year revenue guidance as we continue to execute on the opportunities ahead of us. We look forward to keeping you up to date on our progress. We appreciate your continued interest and support, and we look forward to speaking with you again when we report our second quarter financial results. We wish all of you a good evening.

This concludes today's call. Thank you for participating. You may all disconnect.