Cryoport (CYRX) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

  • Chief Executive Officer - Jerrell W. Shelton
  • Chief Financial Officer - Robert S. Stefanovich
  • Chief Scientific Officer - Mark W. Sawicki
  • Vice President of Corporate Development and Investor Relations - Thomas J. Heinzen

TAKEAWAYS

  • Total Revenue -- $50.2 million, a 14% increase driven by expansion in the cell and gene therapy business and strong demand for cryogenic systems.
  • Life Sciences Services Revenue -- $28.6 million, increasing 18% year over year and representing 57% of total revenue.
  • BioLogistics Solutions Revenue -- $22.5 million, up 16% year over year due to continued commercial therapy development.
  • BioStorage and BioServices Revenue -- $6.0 million, representing 25% growth reflecting high demand for integrated services.
  • Life Sciences Products Revenue -- $21.7 million, an 8% increase driven by robust demand from animal health customers.
  • Commercial Cell and Gene Therapy Revenue -- Grew 20% year over year, reflecting higher patient treatment volumes globally.
  • Adjusted EBITDA -- $1.1 million, an improvement of $1.8 million year over year as the company advances its pathway to profitability.
  • Full-Year 2026 Revenue Guidance -- $197 million to $199 million, raised from previous levels due to increased business visibility.
  • Clinical Trial Pipeline -- 788 trials, a net increase of 43 trials compared to the prior year period.
  • Phase III Pipeline -- 99 trials, representing maturation of the clinical trial portfolio toward regulatory approval.
  • Commercial Therapies Supported -- 23 therapies, including the recent approval of TUDRIQEV for advanced cutaneous melanoma.
  • Cash and Short-Term Investments -- $393.1 million, providing liquidity to support growth initiatives and network expansion.
  • Total Gross Margin -- 47.5%, compared to 48.2% in the prior year period reflecting shifts in the revenue mix.
  • Services Gross Margin -- 50.4%, an increase from 49.7% in the previous year driven by higher utilization.
  • Products Gross Margin -- 43.6%, down from 46.4% in the prior year period.
  • China Revenue Contribution -- 3% to 4% of total revenue, representing a stabilization of the regional market.
  • Operating Costs and Expenses -- $32.6 million, up from $31.3 million due to investments in global supply chain infrastructure.
  • Pipeline Activity -- 31 trials added and 22 removed in the quarter, with management citing eight completions as a sign of maturation.
  • PDUFA Target Dates -- Two new therapy approvals are scheduled for the fourth quarter of 2026 for Arcellx and Capricor.
  • Market Size Forecast -- Approximately $60 billion by 2030, with management citing industry projections for a 30% to 34% compound annual growth rate.
  • Future Regulatory Filings -- Five possible Biologics License Application or Marketing Authorization Application filings expected through the remainder of the year.
  • Divestiture Impact -- The results exclude CRYOPDP financials following its sale to DHL Group in June 2025.

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RISKS

  • Mark W. Sawicki stated, "4 applications that we thought we would have happen in 2026 did get pushed into 2027," representing a delay in the progression of the clinical pipeline toward commercialization.

SUMMARY

Cryoport, Inc. (NASDAQ:CYRX) reported financial results driven by expansion in its services segment and an increasing number of supported commercial therapies. Management stated that the core cell and gene therapy business continues to benefit from higher global patient volumes and the adoption of integrated supply chain solutions. The company indicated that its global supply chain center network expansion is nearing completion, which management expects will drive further operating leverage as clinical trials mature toward commercialization. Management noted that the company achieved positive adjusted EBITDA for the second consecutive quarter while raising its full-year outlook based on increased visibility and demand for its cryogenic systems.

  • CEO Shelton stated, "These results reflect both the increasing number of patients worldwide receiving CGT treatments and the continued adoption of our end-to-end temperature-controlled supply chain solutions."
  • Stefanovich indicated that the company's long-term goal for gross margin is 55% and the goal for adjusted EBITDA margin is 30%.
  • The company received the Healthcare and Pharmaceutical Supply Chain Paris Excellence Award for its global supply chain center in France.
  • Mark W. Sawicki indicated that the sterile kitting operations launched in Belgium have seen "extremely positive traction" with a planned U.S. launch in 2027.
  • The company is onboarding multiple clients at locations in Houston and Belgium to standardize cryopreservation competencies via the IntegriCell initiative.
  • CryoGene launched a cryogenic technical services division to address client demand at medical centers in the Houston and San Antonio regions.
  • The global supply chain center in Paris received ISO 9001 and ISO 21973 certifications during the quarter.

INDUSTRY GLOSSARY

  • Cell and Gene Therapy (CGT): A medical field focusing on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material.
  • PDUFA (Prescription Drug User Fee Act): Legislation that allows the FDA to collect fees from drug companies to fund the drug approval process, often associated with a "PDUFA date" by which the FDA aims to complete its review.
  • Biologics License Application (BLA): A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
  • Marketing Authorization Application (MAA): An application submitted to drug regulatory authorities to allow for the marketing of a medicinal product in a specific jurisdiction, such as Europe.
  • Dewar: A specialized vacuum flask used for storing and transporting cryogens and temperature-sensitive biological materials.
  • ISO 21973: The first international standard developed specifically to address the transportation risks associated with human cells for therapeutic use.
  • Adjusted EBITDA: A non-GAAP financial metric that evaluates a company's operating performance by removing non-cash and non-recurring items from earnings.

Full Conference Call Transcript

Operator: 1. Good afternoon, and welcome to Cryoport's Third Quarter 2026 Earnings Call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for a question. If anyone has any difficulties hearing the conference, 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.

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 we expect or anticipate occurring in the future are forward-looking statements. Forward-looking statements are based on management's beliefs and assumptions, and not on information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made.

Do not undertake any obligation to publicly update or revise any forward-looking statements whether as a result of new information, or future events or otherwise, except as required by law. 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-K filed with the Securities and Exchange Commission and those described from time to time in the other reports which we filed with the Securities and Exchange Commission.

As a reminder, Cryoport has uploaded their third quarter 2026 interview document to the main page of their Cryoport, Inc. website. This document provides a review of Cryoport'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 CRYOPDP to DHL in June 2025. CRYOPDP's financials, which were previously a part of Cryoport'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'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. Jerry, the floor is yours.

Jerrell W. Shelton: Thank you, Todd. Good afternoon, everyone. With me today is our chief financial officer, Robert S. Stefanovich; our Chief Scientific Officer, Dr. Mark W. Sawicki; our vice president of corporate development and Investor Relations, Thomas J. Heinzen. I am pleased to report that Cryoport delivered another strong quarter with revenue of $50.2 million representing a 14% year over year growth. Life sciences services continued to be a key growth driver with revenue increasing 18% and representing 57% of our total company revenue. Within services, our core cell and gene therapy business, delivered very strong results with revenue from commercial cell and gene therapy clients increasing 20%.

These results reflect the growing number of patients worldwide receiving cell and gene therapy treatments and the continued adoption of our integrated supply chain solutions. During the third quarter, Cryoport continued to expand its leadership position within the cell and gene therapy ecosystem, ending the quarter supporting 23 commercial therapies. As our client, Replimune received accelerated FDA approval for tudorfecav for the treatment of adults with unresectable advanced cutaneous melanoma, a skin cancer that is spread too widely or deeply to be safely or completely removed by surgery. We also concluded the quarter with a record clinical trial pipeline of 788 clinical trials, a net increase of 43 clinical trials over the prior year.

With 99 of these trials being in Phase III. We believe our industry leading position will continue to drive commercial revenues as these therapies receive additional regulatory approval. Based on the information we have today, for the remainder of the year, we expect another 5 possible BLA/MAA application filings. 2 potential new therapy approvals, and 1 additional supplemental approval for geographic expansion. it is important to note that both of these potential new therapy approvals have received PDUFA dates from the FDA and are scheduled for the fourth quarter of this year. We also posted solid Life Sciences Products revenue with growth of 8% for the quarter reflecting MVE Biological solutions position as a global leader in cryogenic systems.

Specific revenue contributors in the third quarter included strong demand from animal health customers, as well as increasing demand for our fusion line of cryogenic freezers. MVE continues to be the industry leader and a consistent cash flow generator while also providing support and meaningful synergies with our life sciences services business. Our integrated end-to-end platform across the life sciences ecosystem combined with disciplined and increasing utilization of our global supply chain center network positions us to scale with the industry efficiently and exercise operating leverage as we continue to advance towards sustained profitability. This was also shown in our financial results as we reported our second consecutive quarter of positive adjusted EBITDA of $1.1 million for the quarter.

A $1.8 million improvement year-over-year. With our progress to date on our pathway to profitability initiative, we believe our financial results will continue. To improve. During the third quarter, our global supply chain center in Paris, France received ISO 9 thousand and ISO 22 thousand certifications. As a result, Cryoport Systems received the Healthcare and Pharmaceutical Supply Chain Paris Excellence Award at the 2026 Supply Chain Excellence USA Awards. This was largely in recognition of becoming the first global supply chain solutions provider to achieve ISO 22 thousand certification, which is the first international standard developed specifically to address the transportation risk associated with human cells or therapeutic use. We are extremely proud to achieve these certifications and industry recognition.

Taking these initiatives and achievements into account along with our strong year-to-date performance, combined with our increased visibility, expanding support of commercial therapies, deepening customer relationships, a robust clinical trial pipeline, and healthy demand for MVE's industry-leading products, we are well positioned to meet our 2026 financial goals. Therefore, we are raising our full-year 2026 revenue outlook to $197 million to $199 million. This concludes my remarks for today. Now, I will ask the operator to open the floor for your questions.

Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. On your touch-tone phone, You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star key followed by the number 2. 1 moment, please while we assemble the queue. Your first question comes from Puneet Souda of Leerink Partners. Please go ahead.

Puneet Souda: Hi. This is Phil on for Puneet. Congrats on the quarter. I wanted to ask about guidance By our math, you raised the midpoint by $4 million on a $1.6 million beat, implying Q4 of $50 million to $52 million. The question is, what drives the Q4 step-up in services versus products? And how much macro caution is still embedded in the range?

Robert S. Stefanovich: I think overall, what we did when we looked at guidance for the full year is really to give a prudent guidance for the full year. We had very strong results really over the last 3 quarters in terms of revenue growth and also expansion of our bottom line. And so looking into Q4 and the growth prospects, we think this was the right level of guidance to provide for the year. It looks at a 12% growth year-over-year, and there is certainly upside potential for that as well.

Puneet Souda: Got it. That makes sense. Follow-up question on pipeline expectations. I think in August, I believe you expected 11 more filings and 5 approvals this year. And correct me if I am wrong, but now it is 2 filed, 5 more possible and 2 approvals. The question is what moved exactly Is it FDA timing or sponsor decisions And separately, is it safe to assume that the 2 decisions expected in Q4 are the 2 multiple myeloma drugs, I think, both have PDUFA dates in December? Thank you.

Mark W. Sawicki: Yes. Thanks for the question. You are correct. We did in Q2 predict 11 applications, 5 approvals. In Q3, we had 2 filings and 1 approval. Now we are having an outlook for 5 more with 2 approvals. 4 applications that we thought we would have happen in 2026 did get pushed into 2027. That happens. And then, as far as the approvals, the upcoming PDUFA dates, yes, 1 is Arcellx and 1 is Capricor, 1 in November, 1 in December.

Puneet Souda: Got it. Thank you so much. I will hop back in the queue.

Operator: Your next question comes from Mac Etoch of Stephens. Please go ahead.

Analyst: Hey. Sorry. I think I would be able to find the mute button by now. I would love to get a sense of what you are seeing within your-- or just an update on the China for China strategy now and how that is progressing.

Jerrell W. Shelton: Would you restate that, Matthew, again? I missed part of that. that. I just love to get an update on the China strategy now that you have the production facilities up and running in that area. Just love to get a sense for how demand is trending? Well, you are talking about the global supply chain center network and MVE, MVE China. Oh, okay. Okay. So your question is about MVE.

Robert S. Stefanovich: MVE is robust. it is stable. Its market seems to have stabilized.

Jerrell W. Shelton: It has strength, as I mentioned in my comments, in the animal health market. But All 3 plants are running very well, and the market is cooperating. So we see solid mid-single-digit growth on a continued basis for MVE. Yeah.

Robert S. Stefanovich: And then just for China specifically, China revenue represents somewhere in the range of about 3% to 4% overall of total revenue. And we do not see significant growth in China, but it certainly has stabilized from an MVE perspective.

Jerrell W. Shelton: And you have to remember, on the China operation that supplies components for our other operations both in Ball Ground, Georgia and New Prague. So it does produce product that is sold in the market domestically. it is. It produces export products. I was recently there and saw a number of orders going to Pakistan and other places for, you know, particularly for animal health, but it is an internal supplier as well as an supplier, and it is doing well.

Analyst: Got it. I appreciate the color there. And then maybe touching on those additional facilities that are coming online. How should we think about the margin cadence as we look towards Q4 and into 2020?

Robert S. Stefanovich: Yes. I think if you step back over the several years, we have made significant investments to expand, 1, our first-mover leadership position increase our wallet share through the new standard setting services. At the same time, we have expanded our global supply chain centers, and this will substantially be complete in 2027 with the added bioservice capabilities in Paris, France and Santa Ana, California. This provides us with the capabilities and capacities to support the expected growth in cell and gene therapies. And that really drives the operating leverage that we expect to see. You have seen some of that kick in, in Q2 and Q3, with driving positive adjusted EBITDA and then growing it in Q3.

But we certainly expect more room for operating leverage, going forward As we come online with these additional services. Overall, we look at the some gene therapy market and that is really why we have built out the global supply chain centers over the last couple of years. If you look at the Alliance for Regenerative Medicine recent report, they expect cell and gene therapies to grow at a 6 year 30-34% CAGR from 10.2 billion in 2025 to roughly $60 billion in 2030. So we are well positioned, to capture that additional revenue going forward.

Analyst: I appreciate the color.

Operator: Next question comes from Matthew Hewitt from Craig-Hallum Capital Group. Please go ahead.

Matthew Hewitt: Good afternoon. Congratulations on the strong quarter. Maybe first up, regarding the increased guidance, and you touched on this a little bit, I think, earlier in the first question. But how much of that is a factor of the broad based strength that you are seeing in the market versus the new approval? Is there a way to parse out what you are expecting for that 1 new approval that you saw in the quarter?

Robert S. Stefanovich: No. I think they go hand in hand. There is a broad base that we are looking at both in products and in services. And You saw clinical increases in the quarter in our review piece, and you have also seen that we grew commercial therapy. I mean, commercial shipments by about 20%, or the commercial activity in the services by 20%. So it. it is broad based. it is based on all of those things.

Jerrell W. Shelton: But looking at Q4 in particular, we do not expect new approvals to. that is really not baked into the guidance that we have given. Because new approvals typically take a while to ramp depending on the type of therapy, depending on the company that is actually launching the therapy. So in our guidance, that is really not reflected as a revenue stream. This is really based on the clients we are currently serving. On the growth that we have experienced over the last 3 quarters. We look at year to date growth for the 3 quarters it is about 12%. The midpoint of our guidance is 12%, so we continue or we expect that growth to continue into Q4.

Matthew Hewitt: Got it. And then regarding the new facilities, in California and France, as those get up and running, just a reminder here, does that weigh on the gross margins a little bit initially? And then as you start to get better utilization there, you start to see those margins climb back up? Or is there really no impact on gross margins once you kind of open the doors, if you will?

Jerrell W. Shelton: No. it is a good question. Selectively, if you just look at those facilities, yes, there will be some margin impact. But overall, because we are seeing growth throughout our organization, that will be covered by the overall growth in margins from the other facilities.

Robert S. Stefanovich: Maybe just a clarification, both of those sites are already online with our BioLogistics Services solution. What we are adding to both sites is the additional bioservice capabilities to really add or provide full comprehensive platform that we have built.

Matthew Hewitt: Got it. Thank you.

Operator: Your next question comes from Richard Baldry from ROTH Capital. Please go ahead.

Analyst: Thanks. Looks like MVE had its best quarter in about 3 years. I am sorry, curious if you piece its revenues internally apart Is most of that growth being driven by the new Fusion offering? And then how sustainable, extensible do you think the run rate revenues feel? Thanks.

Jerrell W. Shelton: The animal health business is cyclical, and so we have had a strong couple of quarters. that is mostly animal husbandry. it is mostly in the Bovine area of reproduction, and that is been global. You know, we have had-- there is a demand for some kind of a surge in demand for protein, but we have experienced that. And we have been strong in that side. Freezer side has been fine, and it has not been as robust as the dewar side of the business that is the shipping side of the business.

But the freezer business is very healthy, and of course, the Fusion line started to ship and had some increased demand, so that is helped as well.

Robert S. Stefanovich: And then regionally or geographically, we have seen actually for a quarter, in Q3 over Q3 last year, growth in all 3 regions: the Americas,, Asia Pac, and EMEA.

Analyst: Then when you look at the move to adjusted EBITDA positive, some of that is been with OpEx controlled to steady. Do you think you are at a good run rate here? Do you think you are still looking for places to get greater efficiencies? Or is it sort of grow in line or maybe add a little subset to the top line from here forward?

Jerrell W. Shelton: Well, Richard, Robert will further comment on this, but the operating leverage naturally gives us leverage. It gives us operating leverage, and we built out these capacities for what is coming for being able to handle this demand as it does materialize. And, of course, they have to be fully validated, so it was a drag for a while. But now, you know, we are beginning we are beginning We are not totally there. We are beginning to get on the other side, of that, and that is that is where our pathway to profitability theme is centered. We certainly are cost conscious, but we also know that we have to deliver quality to the market and meet the expectations.

But Robert, do you have other-- yes.

Robert S. Stefanovich: No, it is really, as I mentioned, it was building out the capabilities and capacity that we believe we needed to have on a global basis to support the upcoming commercialization of more cell and gene therapies. And we did state that our overall goal in terms of long-term goal for gross margin is 55%; long-term goal for adjusted EBITDA is 30%. And we definitely see that pathway to those targets. I think as you have more volume go through these centers, global supply chain centers, you will certainly see also greater ability for efficiencies that we believe that we will have within our network. So certainly, we would expect further EBITDA margin expansion in 2027 and beyond.

Analyst: Just last, it is sort of been addressed, but I would maybe looked at it a little more detail. But if you look sequentially on the $50 million to $52 million implied revenue, it is sort of flat to up. What really gates whether it is in a quarter or not?

Jerrell W. Shelton: Talking about Say that again, Richard. What gates, whether it is in a quarter or not? Is that what you said? The revenue guide implies, you know, flat to up about $2 million sequentially. So I am sort of curious what factors the services would tend to be, I think, sort of sequentially higher. Is it really product driven that. that is going to be the up or down on it? No, it is services-driven. But Richard, in our guidance, we just-- we have a minimum, but we chose to be prudent and conservative on that on that side.

Look. there is still a lot of external things, especially with our government and so forth, that could happen, and we just have to take those take those into consideration. As Robert stated earlier, we pushed out the 12%, and increased our guidance by, you know, the midpoint to that extent. But we certainly have a lot of momentum, and we certainly have a bullish outlook on what is coming. But in terms of guidance, we did maintain a conservative stance.

Analyst: Thanks.

Operator: Your next question comes from Subhalaxmi Nambi from Guggenheim Securities. Please go ahead.

Subhalaxmi Nambi: Hi, this is Ethan on for Subbu, Thanks for taking our question. I just wondered beyond animal health, how did reproductive medicine or other MVE markets trend in Q3? And I was just wondering what your outlook for those markets is just going into 2027?

Robert S. Stefanovich: Yeah. We have seen growth, but really, if you step back and look at our company, the main focus is on cell and gene therapies. that is really where we expect to see the growth. The commercial cell and gene therapy revenue alone now represents 20% of total revenue. And then if you add the clinical trial, cell and gene revenue, it is about 47%. So, yes, we have seen, definitely good, especially in the animal health side. We have seen on the product side significant demand, and that is related really to the need for protein production globally. And so we have seen that over the last 3 quarters. And reproductive medicine is growing as well.

Subhalaxmi Nambi: Thank you.

Operator: Your next question comes from Anna Snopkowski from KeyBanc Capital Markets. Please go ahead.

Anna Snopkowski: Hi. Thanks for taking my questions. My first 1 is on the BioStorage/BioServices business. Which I know is a smaller part of the company, but this has been seeing strong growth with, I think, over 20% growth over the last 7 quarters. So do you think you could just touch on what is driving this and how should we think about this business over the long term?

Robert S. Stefanovich: You are absolutely right. We did have very strong Q3. And really over the last several quarters saw in excess of 20% growth year over year, and we expect that to continue. And we are very bullish about biostorage, bioservices. You know, as I mentioned, we are just expanding that service in Paris, France, and in Santa Ana. Because we see a growing need Clients are really looking for us to provide a comprehensive solution. So not just BioLogistics or BioStorage, but really a combined solution of both. So we do expect that to continue to be a double digit grower. And this really is comprised of short term biostorage, kitting, labeling, and, of course, allogeneic therapy fulfillment moving forward.

Mark W. Sawicki: Yeah. Let me just add a little bit to that. So Robert's exactly correct. We are seeing continued diversification of our client base into our bioservice and biostorage business. We also launched our sterile kitting operations in Q1 of this year, and we seen extremely positive traction as it relates to uptake of that business in Belgium, and then that will be coming online out of the U.S. site next year as well.

Anna Snopkowski: Great. Thank you. And then just 1 follow-up. On IntegriCell. I know this is part of a longer-term larger initiative, but how is this rolling out so far, and how do you think about potentially rolling into new regions and how do you pick which regions you expand into?

Mark W. Sawicki: Yes. So IntegriCell is still, as we had mentioned in its early stages. However, we do have multiple clients that are onboarded that are now contributing patient counts into both locations: the location in Houston as well as the location in Belgium. You know, ultimately, our goal here is to over time, provide a competency that provides a network of cryopreservation competencies in both geographies. In fact, we are going to be bringing online the IntegriCell cryopreservation activities in our Morris Plains location as well next year in support of multiple of our clients who have asked us to have diversification of sites and we will continue to see benefit from that.

This is obviously a key opportunity for us as well as the broader cell and gene market. I think you have heard us say this before. Standardization of cryopreservation competencies is something that is extremely important, and it will become more important as these therapies continue to expand, but it also provides the competency for companies that we are working with to expand in the community care setting that do not have the infrastructure to support, you know, any sort of processing on-site. And so they can now engage IntegriCell to support their community care expansion initiatives and still have the, you know, obviously, the regulated, you know, processing competency for those sites.

Anna Snopkowski: Thank you.

Operator: Your next question comes from David Larsen from BTIG. Please go ahead, David.

David Larsen: I am sorry. Can you please talk about expected commercial launches in 2028 and 2020 and the incremental revenue lift, please? Thank you very much.

Jerrell W. Shelton: Sure, David. Thanks for the question. Do you want to take it, Mark?

Operator: No, you can go ahead, Tom.

Thomas J. Heinzen: that is fine. I might add.

Mark W. Sawicki: We have got 2 more that we think will commercialize this year. And then, of course, we said we have more filings, 5 more that we expect I think the street's really looking at 2 main ones. 1 is the Arcellx product. That now is owned by Gilead. there is a lot of Gilead's talked about it a lot on their last quarterly call. And then there is a therapy that could be approved early in 2027 that could be the first therapy approved for an autoimmune disease. So that would be a milestone event for the industry. Overall, we are very bullish on the outlook for commercial therapies. We are bullish for the number of commercial patients being treated.

Across the country and across the globe. And I think 1 example of that is the progression of the Phase III programs we are supporting. I think you have seen over the last few quarters a significant increase in the number of active Phase III programs, which shows that a significant increasing percentage of our pipeline is moving towards those types of regulatory filing events, which we view as extremely positive for the long term prognosis for the cell and gene space.

David Larsen: that is very helpful. Thanks very much. Really appreciate it. Congrats on a great quarter.

Jerrell W. Shelton: Thank you, David.

Operator: Your next question comes from Matthew Stanton from Jefferies. Please go ahead.

Matthew Stanton: Thanks. Maybe to pick up on some of what Mark was talking about there on the Phase III adds. I think you had 5 all of last year. I think you have 13 this year. So really nice progress there. Is any of that tied to better funding we have seen out there? Is it just timing as the earlier stage stuff moves to the pipeline? Any more color on that? And then just talk about, more broadly, to go to the prior question, just between the existing 23 and some of the new ones coming in the Phase III at almost 100 now, just durability for commercial to grow kind of 20%-plus into 2027? Thanks.

Mark W. Sawicki: Yeah. I think, you know, the acceleration that you are seeing is a combination of factors. So, you know, a comment was put, published this in the review that there is an increase in funding in the space. And so you do see a rebound in support of cell and gene from the financial market standpoint, which is extremely positive. You also see continued, consolidation activity where you have larger entities. A good example of this is the Arcellx acquisition by Gilead where they now have obviously significantly deeper pockets as well as a more mature commercial infrastructure to be able to rapidly launch and scale these things very, very quickly.

And then you also have continued prioritization of the smaller biotech space where they are focused, and we. You know, part of the challenge you saw a few years ago was that some of these programs and the clinical trial ads had slowed down, but it is now reaccelerating, and you are also seeing a more focused approach to those therapies that have a definitive, commercial outcome. And so they are pushing, you know, most of the resources into getting their first or second, commercial therapy across the line. So I think it is a combination of all of those. I am not sure if Tom wants to add anything to that.

Thomas J. Heinzen: I just add some color on the pipeline. In Q3, we had 31 adds come in, and 22 were removed. Of the 22 removed, you had 8 trials were completed. We are still seeing that trend of the number of completions being a good thing. that is maturation.

Matthew Stanton: Yep. I appreciate the color there from both of you. Thanks. And then 1 other 1, CryoGene launched a new offering, or I guess division, Cryogenic technical services, CTS. Could you talk about the logic behind this? And, you know, is this something that you will be able to monetize as a service moving forward within CryoGene? Thank you.

Robert S. Stefanovich: So I think for CryoGene, it is really a natural response to the client demand. CryoGene obviously has a very, very strong long term foothold in Texas especially in Houston and with all the medical centers including MD Anderson. And it is expanding, you know, the service offering based on client demand. So that will contribute over time. In additional revenues for CryoGene. They have sites in Houston and in San Antonio, and, obviously, we have talked in the past about the additional sites that they are setting up for the Moffitt Cancer Center in Tampa. Which will be up and running later in 2027.

Matthew Stanton: Super. Thank you. Thanks, man.

Operator: There are no further questions at this time. I will now turn the call back over to Mr. Shelton for closing remarks.

Jerrell W. Shelton: I think you can see, ladies and gentlemen, from the conversation and from the questions and answers, we have a lot of positive things going on. We have fantastic momentum. We have raised our guidance. We had a terrific quarter. And most importantly, we have a really, really bright future. In closing, our strong third quarter and year to date results demonstrated the continued ramp of global patients being treated with cell and gene therapies as well as strong customer adoption of our integrated supply chain solutions.

With the 23 commercial therapies, we currently support and our record clinical trial pipeline we are on a solid growth trajectory as we continue to expand our position across the cell and gene therapy ecosystem. We remain focused on our pathway to profitability initiative and are making significant progress as highlighted by our $1.8 million year-over-year improvement in adjusted EBITDA for the quarter. We are extremely proud of what we have achieved so far, but more importantly, we are excited about what we intend to achieve going forward as Cryoport continues to be an essential partner in supporting the Life Sciences industry and especially the cell and gene therapy part of that industry.

I want to thank all of our team members, and other stakeholders whose hard work and dedication have helped us make today's results possible. We thank you for joining us today. We appreciate your continued interest and support, and we look forward to sharing our continued progress with you when we report our full year financial results. We wish everyone a good evening.

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

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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

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