Q3 2025 Cryoport Inc Earnings Call

Speaker #3: Good afternoon and welcome to Cryoport Inc third quarter , 2020 Earnings conference call . All participants will start in a listen only mode following the presentation .

Speaker #3: We will conduct a question and answer session . If at any time during this call , you require immediate assistance , please press Star Zero for the operator .

Speaker #3: As a reminder , this call is being recorded . I will now turn the call over to your host Todd Fromer from Casey Strategic Communications .

Speaker #3: Please go ahead .

Speaker #4: Thank you . Operator . Before we begin today , I would like to remind everyone that this conference call contains certain forward looking statements .

Speaker #4: All statements that address our operating performance events or developments that we expect or anticipate occurring in the future are forward looking statements . These forward looking statements are based on management's beliefs and assumptions , and not on information currently available to our management team .

Speaker #4: 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 .

Speaker #4: 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 #4: In addition , forward looking statements are subject to certain risks and uncertainties that could cause actual results , events and to differ materially from our historical experience and our present expectations or projections .

Speaker #4: These risks and uncertainties include , but are not limited to , those described in item one , 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 .

Speaker #4: In the other reports , which we file with the Securities and Exchange Commission . As a reminder , Cryoport has uploaded their third quarter 2025 in review document to the main page of the Cryoport Inc website .

Speaker #4: This document provides a review of financial and operational performance and 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 related sale of PDP to DHL , PDP is financials which were previously a part of Life Sciences Services reportable segment , are now presented as discontinued operations .

Speaker #4: And provided quarterly historical information on this basis for fiscal year 2020 . Four . In our first quarter 2025 review document , which remains available on Cryoport Inc website .

Speaker #4: This information is intended to support the financial modeling efforts of those meetings . Information . Please note that unless otherwise indicated , all revenue figures discussed today will refer to continuing operations .

Speaker #4: This includes fiscal year 2025 revenue guidance . It is now my pleasure to turn the call over to Mr. Jerrell Shelton , Chief Executive Officer of Cryoport Inc .

Speaker #4: Jerry, the floor is yours.

Speaker #5: Thank you . Todd , and good afternoon , everyone . With us , this afternoon is our chief financial officer , Robert Stevanovic .

Speaker #5: Our chief scientific officer . Doctor Mark Sawicki , and our vice president of corporate Development and Investor Relations , Thomas Heinsohn . During the third quarter , we continued our strong momentum delivering double digit growth in both our life sciences services and life sciences product segments .

Speaker #5: Notably , revenue from our support of commercial cell and gene therapy grew 36% year over year to $8.3 million . Given driven by the continuing global adaptation of these life saving therapies .

Speaker #5: It is imperative that the growth of the IT is impressive , rather , is impressive that the growth of the regenerative therapies market , which we believe is still in very early stage of development , has remained resilient despite ongoing challenging macroeconomic , political and geopolitical backdrops .

Speaker #5: Within life sciences , revenue increased 16% year over year and represented revenue from continuing operations for the quarter . This included a 21% increase in the bio storage , bio services revenue , underscoring the persistent demand for our integrated platform .

Speaker #5: In the third quarter , we expanded our product portfolio with a launch of MV Biological Solutions . Next generation SC for movie and SC for vapor shippers .

Speaker #5: These cryogenic systems models have been redesigned utilizing innovative technologies to offer customers added protection during extended or challenging shipments. They include several key advancements designed to enhance performance and reliability.

Speaker #5: Of these newly designed condition monitoring solutions . For these doors are integrated with each unit , combining our trusted cryogenic systems with advanced real time condition monitoring technology supplied by tech formed another Cryoport company .

Speaker #5: These innovations reflect Mv's unwavering commitment to support the life sciences with advanced , intelligent , connected assets to safeguard vital biological materials beyond our core systems and services .

Speaker #5: We are progressing on a number of other growth initiatives designed to better serve our clients and diversify our revenue streams . These initiatives include the onboarding of our first clients at four Integra , sell our cryopreservation services , located in Liege , Belgium and Houston , Texas .

Speaker #5: These crowd services are designed to address a critical aspect in optimizing the supply chain for the development and commercialization of cell based therapies through high quality , standardized cryopreserved starting materials .

Speaker #5: We are excited by Integra Sales . Recent progress as it moves forward to become a significant revenue and profit generator . Additionally , in late October , we opened the logistics portion of support Systems new state of the art global supply chain center at the Charles de Gaulle Airport in Paris , France .

Speaker #5: This 55,000 square foot facility provides us with increased ability to serve our clients in the European and global markets . It is designed to support complex life sciences , life sciences , supply chain needs , including Bioacoustics , bioservices and future cryopreservation services and official grand opening is scheduled to celebrate the launch of this facility will be held on November 20th , with Bioservices opening in mid 2026 .

Speaker #5: In addition , we are also advancing toward a a global supply chain center in Santa Ana , California , which is expected to come online in the second half of 2026 .

Speaker #5: This facility will consolidate three existing locations and feature next generation technology to optimize operations and client support . Complementing all of these activities , we have begun implementing our recently established strategic partnership with DHL Group .

Speaker #5: Due to the DHL . Due to DHL size , this strategic relationship will take some time and when completed , it will enhance our positioning in the APAC and EMEA regions and reshape our competitive profile within the industry by leveraging Dhl's global scale and capabilities .

Speaker #5: Regenerative medicine has been advancing steadily , largely driven by the expanding pipeline of regenerative therapeutics entering clinical development and commercialization . Despite any short term headwinds , cell and gene therapies have continued to enter and move through the clinical pipeline , which should ultimately result in growing revenue from commercially supported therapies , crowdsourced temperature control , supply chain solutions are supporting the largest portfolio of clinical and commercial gene therapies in the world , with a record total of 745 global clinical trials in 83 .

Speaker #5: Of these , in phase three , representing approximately 70% of the cell and gene therapy clinical trials . In the third quarter , for Bla Ma filings occurred and three more were filed in October for the remainder of 2025 .

Speaker #5: We anticipate up to an additional seven application filings, one new therapy approval, and two additional approvals for label or geographic expansions, or moves to earlier lines of treatment.

Speaker #5: Of course , the timing of these filings may be impacted by the current government shutdown of the FDA in the United States . While global trade conditions remain dynamic , Cryoport did not experience any new material impact from tariffs in the third quarter .

Speaker #5: Furthermore , we have , of course , taken steps to diversify our supply chain to mitigate potential impacts that could come as a result of tariffs impacts not covered by us , by these , by these , by these mitigations are covered by surcharges .

Speaker #5: With strong momentum , we have achieved year to date and our progress across the board . We are updating our full year 2025 outlook for total revenue from continuing operations to the range of 170 million to $174 million .

Speaker #5: Our team is dedicated to building long term value for our shareholders . Crawford is maintaining and growing its competitive differentiators as the only pure play end to end temperature controlled supply chain platform that supports the largest portfolio of clinical and commercial cell and gene therapies globally .

Speaker #5: This concludes my remarks . I'll now ask the operator to open the lines for your questions .

Speaker #3: Thank you . Ladies and gentlemen , we will now begin the question and answer session . Should you have a question , please press the star , followed by the number one on your touchtone phone .

Speaker #3: You will hear a prompt that your hand has been raised should you wish to decline from the polling process , please press star followed by the number two .

Speaker #3: If you are using a speakerphone, please leave the handset before pressing any keys. Your first question comes from the line of Kyle Kruse from UBS.

Speaker #3: Your line is now open .

Speaker #6: Hello . Thank you for taking the questions and congratulations on the quarter . Maybe just to start the high end of guidance implies a sequential decline in revenues at the same time , you know , you're seeing positive momentum across the entire business .

Speaker #6: You have an increased number of commercial therapies supported , higher number of clinical trials . And you've , you know , launched new products within MV .

Speaker #6: Can you help us reconcile that with the implied sequential decline in guidance ? And then for a second question , can you discuss if the recent release of the FDA draft guidance ?

Speaker #6: Is that support making clinical trials easier has resulted in an uptick in clinical trial interest at your company ? Thank you .

Speaker #5: Well , you had a lot of questions in there . And I think Robert will start answering your financial questions . And Marc will address your FDA questions .

Speaker #5: Yeah , happy to .

Speaker #7: Yeah . Look , you know , you're certainly right in terms of how you phrase the question . You know , given all of the macro uncertainties right now , we think it's a responsible guide .

Speaker #7: It balances the momentum that we are seeing versus the macro conditions such as the current government shutdown and the ever changing tariff landscape .

Speaker #7: I think we've managed it to date very well , and we're obviously , of course , focused on profitable and disciplined growth . If you look at the revenue guidance and the increase in revenue guidance represents about 8 to 11% revenue growth over the prior year from continued operations .

Speaker #7: But as you said , at the same time , we continue to be very bullish on our market leading position . We feel that our long term growth rate will be close to that of the cell and gene therapy market , as you can see in our Q3 performance , and as more and more commercial therapies become come to market .

Speaker #7: In fact , if you look at our commercial revenue right now , you know , it's already a fairly significant portion of our total revenue .

Speaker #7: I think it's roughly about 18 , 19% of total revenue . So we're trying to balance those two . You know , two parts .

Speaker #7: One , you know , the cautious view on on the macro uncertainties , but yet at the same time we are very bullish in terms of the outlook and bullish in terms of finishing the year strongly .

Speaker #5: Mark , do you want to answer the FDA portion ? Sure .

Speaker #8: Assuming you referring to the Rems requirement , is that correct ?

Speaker #6: No . They recently released a three new draft guidances relating to clinical trials . Yeah , yeah .

Speaker #8: So obviously yeah . So they of the draft guidance announcements that you're talking about that came out recently . Some of them are targeting some generic small molecule programs .

Speaker #8: Those don't have a significant bearing on our market . Those that are aimed at the orphan markets and those that are focused around driving biologics approvals .

Speaker #8: Much more quickly , are impactful to us in our clients . And we do believe that those will help drive more activity in the future .

Speaker #8: From a Bla standpoint . You know , just turning to Rems because I think it's important to understand that one too . So the Rems requirement , which has been also one that's been announced , you know , that that will have an even more impactful , you know , positive impact for us as it will drive the implementation and utilization of cell therapies into the community care setting .

Speaker #8: And I think if you look at both Bms's and J&J Carvykti revenue in Q3 , both of them had very strong growth . And in fact , you know , Carvykti folks even came out and said , you know , almost 80% of the patients are being referred from community oncology centers at this point .

Speaker #8: So so I think those both are very predictive of of strong growth in the near future .

Speaker #6: Great . Thank you for that . And then maybe just one last one . Can you discuss if you're seeing increasingly different trends within gene therapy and cell therapy within the broader cell and gene therapy market .

Speaker #6: Thank you so much .

Speaker #8: Yeah . You know , I mean , obviously there's a little bit of of tentativeness around financing and the gene therapy space because of some of the challenges that , you know , have been seen .

Speaker #8: But but that doesn't impact the long term opportunity . And so there's still a lot of new startups in the gene therapy space .

Speaker #8: There's a lot of activity and investment that's going into gene therapy space . But but obviously , you know , the lion's share of funding at this point is , is is still going into the cell therapy side of things .

Speaker #8: And , you know , obviously with the number of of potential approvals moving forward , you know , in , you know , later this year , we've got another potential , as Jerry mentioned , as introductory comments and potentially another seven filings .

Speaker #8: This year . And potentially even another another one new and two supplemental approvals this year . So so there's very strong activity in the cell therapy space as well .

Speaker #9: Just to round that off mark just would point out in our review piece , we we broke down by percentages . The clinical trial portfolio that we have and the number of gene therapies in there is a single digit percentage in the number of vaccines is even smaller .

Speaker #9: It's like 3% . So we're much more exposed to the cell therapy side of the world .

Speaker #8: Yeah . Correct . Thank you . Tom .

Speaker #3: Thank you . Your next question comes from the line of David Saxon from Needham . Your line is now open .

Speaker #10: Oh , great . Thanks for taking my questions . And congrats on another strong quarter here . Maybe Robert , I'll start with you .

Speaker #10: I didn't hear anything on EBITDA guidance . I think the expectation was you'd reach it , reach profitability on a quarterly basis sometime this year .

Speaker #10: So is that still the expectation and then how should we think about profitability , profitability as it relates to 2026 . Could you see that on a full year basis , or are there any meaningful investments we should be aware of ?

Speaker #7: Yeah , no thank you . You know , as you can see from our 25 performance to date , you know , the approved adjusted EBITDA , we approved it by over 10 million for the first nine months , bringing our adjusted EBITDA loss in Q3 to 600,000 .

Speaker #7: So we are getting very , very close to getting and crossing the line to positive adjusted EBITDA from a cash flow perspective , cash flow from operating activities was positive for the quarter .

Speaker #7: We had about 2.2 million positive cash flow from operating activities . And , you know , we think we can get to positive EBITDA or very close to it as , as as early as year end .

Speaker #7: That was our target . At the same time , I do want to highlight , you know , we're obviously trying to balance some of the growth initiatives that we have with driving towards solid positive EBITDA .

Speaker #7: There are some specific client driven growth initiatives that we have . You know , including , you know , the the global supply chain center that we're opening in Paris this month , as well as , you , the Integra cell platform that we started out a while back .

Speaker #7: And those, in some cases, require some upfront investments. So that's really balancing those two parts. But we're certainly making very strong progress towards that goal.

Speaker #7: And overall , you know we like our momentum . We like the positioning that we're in . And our teams are working towards executing on that growth in terms of profitability itself and crossing lines profitability , we have not given guidance .

Speaker #7: Our main focus is really on executing on our initiatives , driving positive EBITDA and obviously creating that pathway to profitability .

Speaker #5: You know , David , you , you , you , you you've heard us talk about the pathway to profitability before , and we certainly are on that pathway to profitability .

Speaker #5: And as Robert points out , you know , we're we're moving toward positive adjusted EBITDA . And and so we we we think possibly we can get there in the fourth quarter .

Speaker #5: And then and certainly early next year and then and that's a surrogate for cash flow . But remember we have a number of facilities which I went over in my opening comments .

Speaker #5: I just mentioned a couple of examples: a number of capital investments taking place, and we know that those are the right capital investments.

Speaker #5: We we vetted them thoroughly , and we know that they're the right thing to do for the future . But when we as we're building those out , you know , in today's accounting , it does it does affect your income statement .

Speaker #5: So so our pathway to profitability includes all the things that Robert said . Plus , you know , building out those facilities . And then starting to experience the operating leverage that comes with getting those facilities up and running .

Speaker #5: And utilized .

Speaker #10: Great . That was that was super helpful . Thanks , Robert and Jerry , for for all that color . Jerry , maybe my second one's for you .

Speaker #10: Just on product . That growth really improved versus kind of the first half . So maybe talk about what's that strength . How much of that is market versus some of those new products .

Speaker #10: You called out maybe driving some mixed benefit . And then in terms of the backlog , I guess , can you talk about that at least qualitatively ?

Speaker #10: And then what level of visibility does that give you into the product growth outlook ? As we head into 2026 ? Thanks so much .

Speaker #5: Yeah . You're welcome David . We we talked about backlog a lot during the Covid period because we had an extraordinary period . But we we we don't talk about backlog now as much because we are on more normal .

Speaker #5: We're in a more normal market , which is about a 6 to 8 week lead time . It's not it's no longer six months or a year lead time .

Speaker #5: It's it's back to the normal , which is about , you know , six weeks lead time . So we do monitor our sales trends .

Speaker #5: We do monitor our order intake . And that order intake does give us indication that the market is is beginning to stabilize . And of course , you know , government shutdown hasn't helped us there any .

Speaker #5: But but it's still continues to go on . It hasn't helped us because it does slow down . The government sales . You know , that that that are associated .

Speaker #5: But but so so we we we're we're doing well in terms of the industry and the and and the stabilization . There was no impact on the new new things that I talked about in my comments in opening up .

Speaker #5: No revenue coming in from that . It wasn't time . It was . It does take time for these things to get out the the three , the two doers that were developed with the integrated condition monitoring at , at Mbv are focused on the animal health business .

Speaker #5: And and so that's a seasonal business . And there will be an uptake there . But we have a number of things going on at Mvh .

Speaker #5: Does that answer your question , David ? Or is there other parts to it .

Speaker #10: That , that that was super helpful . So thanks for that . I guess maybe if I could rephrase it like how , you know , the market has been stable year to date , I guess as we think about our models for 2026 , do you is is making the assumption that that continues a fair assumption .

Speaker #10: And then with , you know , I guess those products , product launches and the animal health phase , maybe some some increased demand across the other end markets , like maybe how should we frame or how would you frame product growth potential for 2026 ?

Speaker #5: I would look at it with stability and use a very a very high single digit growth rate .

Speaker #10: Okay . Perfect . Thanks so much , Jerry .

Speaker #3: Thank you. Your next question comes from the line of Puneet. Sudha from Leerink Partners, your line is now open.

Speaker #11: Yeah . Hi guys . Thanks for the question . So maybe first one on some of the cell therapy exits that we have seen .

Speaker #11: I mean , you're delivering relatively strong growth . Some of it is comps , but some of it is is just overall market stability , which you talked about .

Speaker #11: But just trying to understand , you know , if you could contrast with what we're seeing , Takeda exiting its allogeneic programs . Galapagos is winding down their programs .

Speaker #11: Novo is divesting its cell therapy assets . Are you seeing any downstream impact from those exits on your pipeline or the service demand overall ?

Speaker #11: And then within that , you know , as as as Jerry said , high single digit growth is that , you know , still something you're I mean , is that your contemplating , you know , into 2026 and 27 just given , you know , sort of these exits and maybe just provide us any context for backfilling some of these programs that might have been lost .

Speaker #5: Yeah . We're honored that you're on the call because we thought you might miss it because of conflicts . But let me start and then Mark will add to what I have to say .

Speaker #5: First of all , the 9% I said high single digits . So you said nine . That's fine . But that applies to MV product segment and you mix product and services .

Speaker #5: And so you know , in the service segment where you have Galapagos , you know , you cited and some of the other activity that's happened and that's that's normal .

Speaker #5: Puneet , you should you probably know this , but it's normal to have puts and takes and people , you know , make their investments and other and sometimes they can support them financially going forward .

Speaker #5: Sometimes they can't . Sometimes they're rationalizing what they're doing . And we have no insight on that . What we do know is we are continuing to grow .

Speaker #5: We continue to see robustness . We we we have an increase in the clinical trials that we support , with 83 being in phase three , I think it was 83 and phase three and and we're we're doing well and we see a continued buoyancy in the market .

Speaker #5: This science is not going to stop . It's going to change the way medicine is practiced around the world . It just takes time and it has had some headwinds , but it's buoyant .

Speaker #5: It's strong and we're growing and we intend to continue to . Do you want to add to that ?

Speaker #8: I think you answered it pretty well . The only thing I would just add is Jerry's , right . I mean , I think some of the changes that you mentioned are really strategic portfolio decisions .

Speaker #8: I don't think they're market driven decisions . You know , there's also other companies that are putting a lot more money into and expanding their programs from , from a top five pharma standpoint .

Speaker #8: So so we don't have a level of concern around that . You know , as as Jerry had mentioned , very strong pipeline activity .

Speaker #8: You know , very strong activity from a regulatory standpoint . You know , as we had mentioned , upwards of another seven filings this year upwards of potentially another 25 filings next year .

Speaker #8: So , so there's there's a lot of activity in the space which will continue to expand the number of commercialized therapies and the revenue associated with those therapies .

Speaker #8: As the market matures .

Speaker #9: Could I .

Speaker #11: Just that's .

Speaker #9: Helpful in there . Just to just to pile on .

Speaker #11: Yeah . Tom .

Speaker #9: Please , just to point out September funding in biopharma was quite strong in October was the best month of the year so far .

Speaker #9: We had over 20 IPOs and follow on offerings of greater than 100 million . In October alone . So some of the programs you mentioned are falling off , but certainly other ones are coming in up and taking their place .

Speaker #9: But go ahead .

Speaker #11: Yeah , that's about the point . Yeah , yeah . No thanks John . On the government shutdown piece and the implied for Q guide , I'm just trying to understand how should we think about the the segments within the guide for the fourth quarter by logistics versus bio storage ?

Speaker #11: Bioservices versus the MV Life Sciences product line . Maybe just help us understand , you know , how should we think about modeling each of those ?

Speaker #11: If you could provide some segment commentary and just maybe just if you could pinpoint in the government shutdown exactly . I mean , what our customers telling you .

Speaker #11: What are some of the worries here? If this shutdown extends into December.

Speaker #5: You know , on the first part of your question , it depends on what you think about the government shutdown . You know , frankly , you know , the government shut is temporary right now .

Speaker #5: You can't make a filing . You can't pay your fees for a filing . But that's going to end soon . It can't go on forever .

Speaker #5: And there's an election coming up , which I think will motivate a political end to the shutdown . And then we'll see some things open up .

Speaker #5: We'll see things start to move , start to move through , and we'll catch up . So I , I , don't it's not going to last forever .

Speaker #5: The government shutdown isn't . And and and again with under the under the backdrop we've had we've shown substantial growth in in in you know , in spite of any headwinds there .

Speaker #5: Mark , do you have anything to add to that .

Speaker #8: Yeah , I think you answered it . Well I mean , you know , on a service standpoint , we haven't seen any impact other than the delay in filing activity , which they just can't do because they can't pay .

Speaker #8: As Jerry mentioned , they're filing . They're they're they're application fees . That's the only impact that we've seen is there may be a short term delay in some of the filing activity , but the service activity still remains very robust .

Speaker #5: And then .

Speaker #7: Just looking at Q4 , without going into too , too much detail , obviously we expect year over year increase in on the services side on the product side , it largely depends on , timing , especially if you look at some of the larger freezer orders or even some of the potential delays in government shutdown that could , you know , just have an impact on timing of whether those are going to come in in Q4 or be be shifted in Q Q1 .

Speaker #5: That's because their capital expenditures and somebody has to sign off on them .

Speaker #11: All right. Thank you, guys.

Speaker #5: Appreciate it . Does that help ?

Speaker #11: Yes . Thank you .

Speaker #5: Thank you , thank you .

Speaker #11: Yes it did .

Speaker #3: Thank you . Your next question comes from the line of Matt Stanton from Jefferies . Your line is now open .

Speaker #12: Hey . Thanks . Maybe one for for Mark just on the commercial trends . You're tracking up over 30% here year to date .

Speaker #12: It sounds like you saw some approvals here early in the quarter. Continue with more filings. And then I think next year, 2025, which is a big number.

Speaker #12: Can you talk about the durability of the growth in terms of what you see in here from customers ? And as we think about that kind of 30% plus , how you feel about that on the commercial side into 26 , I mean , is there opportunity for that to accelerate even further if some of these things kick in on Rems or some of these filings kick in ?

Speaker #12: And your point earlier start to get get signed off and get out there . But just talk about the kind of growth algorithm on the commercial side .

Speaker #12: Thanks .

Speaker #8: Yeah . You know , you know , I think as you focus you got to focus on two things . One is the existing therapies as they mature , they move to earlier line and they and they go through global expansion .

Speaker #8: And you know , as we had mentioned earlier , I mean , both BMS and Johnson and J&J have come out with very positive comments around growth .

Speaker #8: And there and their data , their financial data supports that . You know , you know , Johnson said . You know , their goal is , is 10,000 doses by year end and 20,000 patients by the end of 2027 , which is a substantial increase .

Speaker #8: And then you have the newer therapies as they launch . They're also expecting , you know , significant ramps , you know , vertex has come out and said they expect to see start to ramp more , more , you know , more significantly .

Speaker #8: And and then we have , you know , other data on some of these earlier launches , which most of it has come out at or ahead of guidance .

Speaker #8: So if you take those in addition to the new filing activity, we think it will remain robust in 2026 and beyond.

Speaker #12: Okay . Great . Thanks , Robert . Maybe just to go back and forth a few times for some the for Q ramp .

Speaker #12: I mean , I know last quarter you guys were kind of saying , you know , for Q probably higher than , than three .

Speaker #12: Q part of that seasonality , obviously , three Q came in better than than we expected . Is it fair to say that , you know , the sequential quarter over quarter implied for Q I mean , the government shut down maybe some of the timing you talked about .

Speaker #12: I mean , is that kind of a low single digit million impact tied to those ? And maybe erring on the side of conservatism , just kind of thinking about three months ago for Q higher than three .

Speaker #12: Q and now we have kind of the opposite playing out . And maybe just confirm there was nothing kind of that fell in three Q that you had previously expected to fall in .

Speaker #12: Four Q thanks .

Speaker #7: Well , no , there's there's not . But you , you you already really framed it . You know , I think it's really balancing that .

Speaker #7: And , you know , and looking at our guidance , certainly we we have upside potential . No question . But given some of the uncertainties , we felt that , that guidance kind of reflects where we stand right now to , to acknowledge some of those other aspects that we discussed earlier .

Speaker #12: Thank you .

Speaker #3: Thank you . Your next question comes from the line of Subbu Nandi from Guggenheim . Your line is now open .

Speaker #13: Hey guys, thank you for taking my question. You recently announced that the Typekit systems received ISO certification. Could you speak to what this means in terms of your customer win rate or any competitive dynamics?

Speaker #13: How meaningful is this ?

Speaker #5: You know , I want Mark to speak to that . But in addition to that , ISO , we've also won an award or two .

Speaker #5: And certainly one that we're proud of . And and we and we did help on that ISO . So Mark , take it away .

Speaker #8: Yeah . So so ISO 21 973 which is really around the governing of handling of cell therapy based materials is what we receive that certification in .

Speaker #8: We are the first entity that has received a formal ISO certification. Others have claimed that they are compliant with it, but we actually have received the certification from the ISO governing body related to that.

Speaker #8: Yeah , on a global basis . So what it really does , is it reinforces us as the best in class and the gold standard as it relates to the management of these therapies on a , on a , on a global basis .

Speaker #8: And , and reinforces the obviously the quality paradigm that we have . And , you know , I think as you as you look at our growth as it relates to commercial revenue as well as our clinical trial ads , the market continues to respond very favorably to that as as they continue to put a larger share of the overall clinical trial count , as well as the commercial activity into our portfolio .

Speaker #8: So we believe that will be a continued positive influence on on decision making by our our clients and sponsors .

Speaker #5: I mentioned that award that we won also part .

Speaker #8: Yeah , yeah , we actually won two awards . Cphi Award , which is which is one of the larger chemical industry awards for , for excellence of supply temperature control , supply chain solutions .

Speaker #8: And then we also want another one from a biotech agency , which also reinforces that in the quarter . So , you know , I think the markets are absolutely responding to our our platform as best in class .

Speaker #13: That's great . Thank you for that . Any updates you can share on how you're progressing with your China ? First strategy ? What milestones can we expect as we look to growth in that region ?

Speaker #13: For you guys ?

Speaker #5: You know we we have not assumed any growth in China for the will not be assuming any growth in 2026 . And we there's no change right now .

Speaker #5: We do have some some some efforts underway . It does take time to implement , you know , strategies of that nature . And we hope by 2027 it'll be it'll be certainly one thing we cannot ignore .

Speaker #5: China . It's a it is an advanced country . It has a very high population , very big population . And it has resources and it can move very quickly .

Speaker #5: So we will continue to work on our China strategies , but we don't have anything we can report further right now .

Speaker #13: Perfect . And a last one for me . Is there a potential for a catch up heading into 2026 . Just given the environment is improving something that you touched on previously ?

Speaker #7: You're talking about a catch-up in terms of.

Speaker #5: What are you talking about in terms of catch up .

Speaker #13: Catch up in ordering , just do you anticipate there could be some sort of catch up orders next year ?

Speaker #7: So I .

Speaker #9: Think she's referring to the product side guys .

Speaker #7: Yeah . When you're talk about the products , I think what we said is it's really stabilizing . I don't think we can we can speak of that at this point in time and in general , conceptually , obviously , more and more material is being developed that requires cryogenic storage and MV being the largest global provider of storage and cryogenic systems .

Speaker #7: Certainly, we will be the first beneficiary of that. But at this point, it’s just stabilization of the market that we can see.

Speaker #7: .

Speaker #13: Perfect . Thank you so much , Vince .

Speaker #3: Thank you . Your next question comes from the line of David Larson from Btig . Your line is now open .

Speaker #14: Hi . Congratulations on another very good quarter . It looks like the number of clinical trials , the growth rate year over year was the highest it's been in like two and a half years .

Speaker #14: And just any thoughts on the big beautiful bill act reductions in Medicaid enrollment reductions in exchange enrollment maybe as high as 10% or 30%?

Speaker #14: Does that matter or not ? Any thoughts on payer mix or most people getting any gene therapies ? Are they covered by commercial plans ?

Speaker #14: Not Medicaid and exchanges ? Any thoughts there would be helpful ?

Speaker #8: Yeah , I personally don't think it's much impact at all . You know , the vast majority of therapies by understanding are not being covered by by public funds .

Speaker #8: They're traditionally are typically private plans that are reimbursement at this point .

Speaker #14: Okay . And then do you have any concerns around drug pricing , like with with price caps due to the inflation Reduction Act or , you know , rebate flow limits on price increases ?

Speaker #14: Has that entered into any conversations at all, or not?

Speaker #8: No .

Speaker #9: Gene therapies are exempt from all of that? Dave.

Speaker #8: Yeah , yeah , I was going to say the same thing . I said . Yeah , I mean , you know , the white House has actually come out and support a cell .

Speaker #8: And Gene and their interest in continue to support it . And aggressive manner . And there is they are exempt from some of those pricing constraints that that the white House is currently working through .

Speaker #9: They're also not impacted by any any tariff talk either .

Speaker #14: Okay , great . So minimal regulatory risk heading into 26 . Fantastic . And then in quarters past you talked about the growth in number of clients at these bio storage facilities .

Speaker #14: I think in new Jersey . And also like allogeneic storage any any color there in terms of like capacity or number of client growth .

Speaker #8: Yeah , yeah . I mean , we're still continuing to on board a significant number of clients at those sites , both existing and new clients .

Speaker #8: And , you know , so so that rate continues to be very robust , as evidenced by , by the sales data that , that we've put forth .

Speaker #8: You know , publicly . So we anticipate continued growth in the Bioservices area into 26 based on that .

Speaker #5: By the way , David , this is not a singular thing . This is not a singular strand . I mean , our we built these on a strategic basis .

Speaker #5: We built them to support our clients and to create more of a one stop shop . And because clients , you know , actually prefer doing business with less vendors and especially one that they can trust .

Speaker #5: So it's kicking in, and our clients are beginning to take hold of our storage by bioservices operations within the Cryoport system.

Speaker #8: We're averaging almost two audits a week at this point . So that's that's obviously a , you know , a significant volume of new workflow that's coming into the facility .

Speaker #14: So just one .

Speaker #5: More strategy . You're witness a strategy play out right now .

Speaker #14: Great . One more quick one integration I get questions on that all the time . Just any more color there would be helpful .

Speaker #14: It sounds like you're building a new facility . Is that going to support global efforts for Integra ? And do you have revenue coming in for that business yet or not ?

Speaker #14: Just any more color would be helpful .

Speaker #5: Well , let me let me start . And Mark can give you more detail , but you know , Integra is another strategic endeavor .

Speaker #5: And and we do have a network in mind , but we are carefully going into the development of Integra cell as Mark said earlier , we have revenue coming in at both locations , but I want to see those those locations closer to cash flow , to positive cash flow before we add other operations .

Speaker #5: We do have plans for other operations . They will be added . The network will work all the information that we've gotten so far is very .

Speaker #5: And now we're on the uptick by getting customers , clients and revenue coming through those two facilities . I'll just turn it to mark after that .

Speaker #8: Oh yeah . Jerry , as Jerry . What Jerry said is exactly right . You know , we opened this facilities at the end of Q3 last year .

Speaker #8: And, you know, the tech transfer process takes time because it's part of the production process. So there's regulatory activity that needs to occur for adoption.

Speaker #8: But we have completed our first tech transfers from both biotech and top ten pharma . And we have started to generate revenue from from both sites .

Speaker #8: But we have completed our first tech transfers from both encouraging it'll , you know , revenue will . Will ramp modestly in 26 with a significant ramp , almost a hockey stick modality .

Speaker #8: Post 26 .

Speaker #14: Congrats on a good quarter . I'll hop back on the Q .

Speaker #8: Thank you .

Speaker #5: Thanks , David .

Speaker #3: Thank you . Your next question comes from the line of Mark Eatock from Stephens , Inc. . Your line is now open .

Speaker #15: Hey guys . Thanks for taking my questions , Robert . Maybe just a quick one on on margins . Just as this new facility comes online , can you just walk us through how these start up costs and the ramp and timing have been factored into your model , and just how you expect that to influence margins over the next few quarters ?

Speaker #15: Thanks .

Speaker #5: Oh .

Speaker #7: It's a very good question . And it's again , one of those balancing acts because you're absolutely right . You know , we have new facilities going online .

Speaker #7: You and I went online, as Mark mentioned. We have a global supply chain center in Paris by the Charles de Gaulle Airport going online.

Speaker #7: The official opening being in a few weeks from now . At the same time , we are seeing some operating leverage already of the existing facilities , and that allowed us to show , you know , gross margins reaching 48% and even higher on the service side .

Speaker #7: In particular , we do typically have start up costs that we , we we we run . But then as we open the facilities , you'll see some impact on , on the margins .

Speaker #7: So while we see operating leverage in some of the existing facilities that are driving higher margins , you'll have some margin depression by these new facilities coming online .

Speaker #7: And starting to see revenue ramp over time . So that's , you know , as we start and really 26 , 27 is are really about that operating leverage , really about driving utilization of the existing footprint .

Speaker #7: Global footprint that we have that will ultimately drive the gross margins. Our target is 55% gross margins overall and a 30% EBITDA margin.

Speaker #7: And obviously there's still some time to go to get to the gross margins . But we'll see that operating leverage kick in later in 2026 .

Speaker #15: Appreciate that . And just touching on those long term margins , I can you just highlight your thinking in terms of timing around those as well ?

Speaker #15: I know it's been a longer dated proposition . I just kind of want to get your updated thoughts there .

Speaker #7: Yeah , we're not giving guidance on that at this point in time because it's really if you look at the cell and gene therapies market , it is still a fairly new market when it comes to actually the commercialization of therapies .

Speaker #7: So we want to see more progression in more therapies come to market . But we're clearly on that pathway . As you can see in terms of the significant improvements to adjusted EBITDA as a first indicator .

Speaker #7: And will certainly drive that further into 2026 and 2027.

Speaker #15: I appreciate the context . I'll leave it there .

Speaker #5: Thank you . Thank you .

Speaker #3: Thank you. There are no further questions at this time. Turning it over back to Jerrell Shelton. Your line.

Speaker #5: Well , thank you very much . And thank you for your questions and our discussions . In closing , in the third quarter , we continue to see strong momentum in our business .

Speaker #5: This included double digit revenue growth in both our core business segments , our life sciences Services segment . The key driver of our future growth grew 16% year over year , driven by 21% increase in bile storage .

Speaker #5: Bioservices revenue and a 36% increase in commercial cell and gene therapy support . We also continue to see further steadiness in our life science product business , where revenue grew 15% for the quarter .

Speaker #5: Cryoport is positioned as the critical temperature control supply chain company supporting the life sciences that de-risk the end to end delivery of cell and gene therapies worldwide .

Speaker #5: Thank you for joining us today . We appreciate your continued support and interest in our company , and look forward to speaking with you again .

Speaker #5: When we report our fourth quarter and full year financial results .

Speaker #3: Thank you . Ladies and gentlemen , this concludes our conference call for today . We thank you for participating and ask that you please disconnect your lines .