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spk03: We need it. Ladies and gentlemen, thank you for standing by, and welcome to the Cryoport Incorporated third quarter 2021 earnings call. Now, during today's conference call, all telephone participants will start in a listen-only mode, and later we'll conduct a question-and-answer session. Now, at that time, if you have a question, you can queue up over the phone lines by dialing 1-4, that's 1 followed by the 4, on your telephone keypad. If you need to speak to the operator, you can do so at any time during the conference. Please dial star-0. And a quick reminder for today, this event is being recorded. It's November 4th, 2021. It is now my pleasure to turn the call over to Mr. Todd Frommer, President of KCSA Strategic Communications. Please go ahead, sir.
spk01: 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 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. 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 file with the Securities and Exchange Commission. It is now my pleasure to turn the call over to Mr. General Shelton, Chief Executive Officer of CryoPort. Jerry, the floor is yours.
spk08: Thank you, Todd. Good afternoon, ladies and gentlemen. We appreciate your joining our earnings call today. With me this afternoon is our Chief Commercial Officer, Mr. Robert Stavanovich, our Chief Scientific Officer, Dr. Mark Sawicki, and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. As a reminder, we have uploaded the third quarter 2021 in review document to our website. It can be found under investor relations in the events and presentation section. The document provides a review of our recent financial and operational performance and a general business outlook. If you have not had a chance to read it, I would encourage you to go to our website and download it. Now for a brief update followed by your questions regarding our third quarter results. I'm happy to report that our third quarter was the fifth consecutive record quarter for Crowdport. Strong demand coupled with superlative execution from our team drove our solid performance in the quarter and we are firmly on track to deliver record revenue for the full year. During the third quarter, we added 38 new customers. At Crowdport Systems, which is double the prior quarter's new wins. Revenue from our eight commercial agreements increased 44% year-over-year, while Cryo PDP added 72 new customers during the quarter. The number of clinical trials we support increased 13% year-over-year, and organic growth from Cryoport Systems and Cryo Gene delivered a 38% year-over-year revenue increase. Cryoport on the whole performed well in the third quarter with cryo-PDP and MBE biological solutions delivering solid growth that was well above their historical growth rates. Cryoport is setting the pace for the cell and gene therapy supply chain through our deep expertise in comprehensive solutions. Our pipeline of commercial customers is the largest in our history. We're now supporting 582 regenerative medicine clinical trials, with 70 of them in phase three. Approximately 30% of our pipeline is allogeneic, of which 32 are in phase three. We're currently supporting eight commercial therapies in regenerative medicine, and for the remainder of this year, we anticipate up to another four MAA or BLA submissions for Cryoport-supported products. In 2022, we are looking for up to 21 additional filings. On the financial front, our total revenue in the third quarter of 2021 was a record $56.7 million, up from $11.2 million in the same period of the prior year. On an organic basis, that is without acquisitions, this translates into 38% year-over-year growth. As for total revenue in the period, Our biopharma pharma business continues to be strong, accounting for approximately 81%. Overall, we had a revenue increase of 371% over the third quarter of 2020. In closing, we're proud of our performance, the momentum we are seeing in our business. Our strong results through 2021 are a testament to our strategic resource allocation, superb execution by our talented teams of employees, and ever-improving capabilities. It is our relentless pursuit of superb execution and innovation that continues to set us apart and support our leadership position. Operator, please open the line for questions.
spk03: Certainly, and ladies and gentlemen, if you would like to register for a question, you can do so by dialing 1 followed by the 4 on your telephone keypad right now. You'll hear three tones to acknowledge your request. Once again, to get for questions, please dial 1 followed by the 4 on your telephone keypad right now. All right, our first question coming from the line of John Sauerbeer from UBS. You may now proceed.
spk06: Hi, thanks for taking my question. So I guess new wins were up around two times from the prior quarter, and total trials were up mid-teens year over year. Can you maybe talk a little bit about some of the competitive contract wins, and do you think that Cryoport Systems is currently taking share from competitors?
spk08: Now, John, that's a good question, and Dr. Sawicki is best suited to answer that question. Mark?
spk03: Yeah, thanks, Jerry. Yeah, I think we're absolutely still pulling share from the market. You know, that's our goal, ultimately, is to continue to, you know, increase our overall market, in particular in the cell and gene space. You know, the 38 wins to us is significant, in particular as you're coming out of a, you know, COVID lull as it relates to new business development, so we're very, very comfortable that we are pulling share.
spk06: Got it. Appreciate that. And, you know, I think gross margins declined around 70 bps. Can you talk maybe about any of the impact you're seeing there from supply chain issues or inflation that is impacting the margins?
spk08: Yeah, that's a good question. And I think Robert is best suited for that.
spk10: Yeah, first off, you know, we are a supply chain company, so obviously we're very in tune with that and we're very focused on that. I think if you look at the third quarter, our primary objective during the third quarter was really, one, to ensure minimal disruption to our client base, which we did very successfully, and then, two, continue to drive market share and revenue, which allowed us to drive that record revenue for the quarter. Having said that, obviously, like all companies, we've experienced supply chain challenges, such as increased cost of suppliers and transportation costs. We're very much focused on that. We have now clear line of sight into the supply chain to ensure that we have the resources and capacity for our expected growth for the next quarters. So we believe that, you know, the Q3 was really the peak of the supply chain challenges. Having said that, obviously this is an ongoing issue that we're very much focused on. We expect that, you know, to improve over the next, you know, quarters.
spk06: Scott, I guess this last question here. Since acquiring Cryo PDT, you've done a couple tuck-in deals there in Europe and Australia. Any thoughts on opportunities where there could be potential for new geographies for tuck-ins there?
spk10: Any opportunities in terms of the growth expectations in those regions?
spk06: Are these new regions you might be looking at or similar to the deals that you did in Belgium and Australia?
spk08: Let me explain that. We're looking at all regions. We divide the world into the Americas, EMEA, and APAC, and so we're looking at all regions. The highest growth region we're looking at right now for the future is, of course, APAC. We think that the China market is really interesting, and it's going to be large, and we have several initiatives going on there. So we're looking globally. We're looking regionally. And we have a particular focus on Asia-Pac at this point.
spk10: And we've in the past talked about our M&A strategy. That strategy includes more of these tuck-in acquisitions that you've seen with the Belgium and Australia acquisition, as well as potentially our strategic opportunities.
spk06: Congrats on the quarter, and thanks for taking my question.
spk12: Thank you.
spk03: Thanks. That's 1-4 to queue up for questions, 1 followed by the 4 if you'd like to queue up for questions today. Our next question coming from the line of Chad Wyatrowski from SVB LearNIC. You may now proceed.
spk13: Hi, guys. Congrats on the quarter. Real quick, just can you provide any color on delta-driven clinical trial delays seen around the space as of recent? And have you seen any impact in certain geographies? And if so, where do you see this trending in FY22?
spk08: I think Tom is on top of that, so he can give you some insight there, our insight.
spk09: Actually, and Mark can echo this after I finish, but we've seen a good clinical trial count add, just like we've added new customers in the corridor at a good pace. We haven't seen a slowdown. I know some of the reports out there, but if you look at the overall macro trends, the amount of money in the space, the amount of new companies being formed in the space, I think there's quite a big pipeline of INDs at the FDA and the EMA and the JDA, the China version we're a little bit behind on, and we see those coming through. So I don't think we're going to see it slow down at all. It seems to be picking up, as evidenced by our forecast of BLAs and MAAs in 2022. Mark, do you have any further thoughts?
spk03: No, Tom's exactly right. In fact, I don't see any lingering impact or delays associated with COVID-related activity. Everything's back to pre-COVID levels. In fact, as Tom had mentioned, the activity is actually stronger at this point in time. So we're very confident in the near future.
spk13: Great. Thanks for taking the question, and congrats again on the quarter.
spk12: Thank you.
spk03: All right. Our next question coming in from the line of Brendan Couillard from Jefferies. You may now proceed.
spk05: Hey, guys. This is Matt on for Brent. Thanks for taking the question. Maybe to jump back over to the APAC region, clearly an area of focus for you guys. Can you just talk about the market share dynamics there for you and how that compares to maybe the U S or, or Europe. And then in terms of competition and some of the key markets there, like Korea and China, you talk about, you know, local players versus kind of internal homebrew at some of these customers, you know, what's the competitive dynamic there today. Thanks.
spk08: I'll comment first and then I'll let Mark comment, Matt. But yeah, Look, these are developing – this is a developing region, the Asia-Pac region, and we have initiatives going on in China and in Japan, and we have locations, of course, in Singapore and in North Korea and in Australia. So we're in tune with what's going on, but it is developing, and there is local competition in each of those areas. But nothing is set right now in terms of full support of the industry. And certainly, we are serving the industry, I mean, serving those countries internationally. What we're looking for is more domestic support and growing the domestic business as well. But it's absolutely a focus for us. And Mark, do you want to add to that?
spk03: Yeah, absolutely. Yeah, so if you take a look at our numbers, our APAC numbers are up from a clinical trial standpoint about 35% year over year. So we are seeing an acceleration in that activity. The biggest challenge associated with APAC, in particular China, where the lion's share of clinical programs are running, is most China programs have traditionally run under, in particular, early phase under what's called a Ministry of Health mandate, not the Chinese FDA. And the regulations associated with those programs are much looser than a formal Chinese FDA or US or European authority. As they're starting to mature, they're moving into a more formal state. So they're now starting to evaluate and looking at things like supply chain in a much more rigorous regulatory format. And that's where we're seeing you know, the increase in demand as these things transition over to more traditional-type programs, and that's just going to accelerate. So, you know, that local, quote-unquote, homebrew that you were talking about will have to mature through, obviously, partnerships with folks like, you know, Cryoport Systems to be able to support this type of activity from a regulatory scrutiny basis moving forward.
spk05: It's really helpful. And then, you know, the release, I think you're supporting about 30% of the pipelines allogeneic, which is, I think, kind of on par where it's been historically. But given the development in that space, 32, you know, phase three clinical trials, can you just update us on how you're thinking about serving the allogeneic market going forward as some of these start to commercialize? And then maybe, you know, some of the moves you've made over the past few years that better position you to serve that market going forward? Thanks.
spk03: Sure. I can answer. I can make that if you want, Jerry.
spk08: Go ahead. Go ahead, Mark.
spk03: All right. Yeah, so as you guys are aware, obviously we've been building out what we call our supply chain centers, which include a full bioservices competency. And one of the reasons that we've done this is to be able to support the staging of allogeneic volumes as it relates to batch manufacture and distribution. One of the tie-ins to this is having the ability to support that local storage and distribution on a regional basis for our clients, as well as building the infrastructure and the inventory through, obviously, MV Biological Solutions for the aluminum aspect of that distribution and scale of processes. We're absolutely entertaining in preparing for it, and we do have the infrastructure in place to be able to support any of these launches as they move forward.
spk00: Super, thanks.
spk03: All right, next question coming from the line of Paul Knight from KeyBank. You may now proceed.
spk11: Hi, guys. The... The back out obviously shows very good core growth on logistics. The acquired businesses, would it be fair to say that they're up similar to 2Q, meaning up about 20% organically? Is that in the ballpark? And then it does look like they were kind of flattish sequentially. Is there any seasonality in those acquired businesses that create that kind of sequential flow? That would be kind of my first question.
spk10: Yeah, I think just to address, you know, the performance of the, you know, of MV biological solutions for IPDP, you're absolutely right. Both had actually very significant growth compared to their historic performance, and actually well above, you know, the number that you mentioned. So very, very strong performance by both business units. and continuing very strong demand, both for MBE Biological Solutions freezer and shipper solutions on a global basis, as well as for P2P services. If you look at the revenue being flat compared to the very strong record revenue they had in Q2, you're right. It's hard for us to say that it's seasonal. Certainly there were some supply chain related delays that we experienced during Q3, as I mentioned earlier. that had some impact on the revenue, but overall, again, it's very, very strong performance, and we see that strong performance continuing into Q4 and beyond.
spk08: Paul, the growth numbers were almost, not quite, but almost double what you said, and the backlog at MVE is a record backlog, so we're in great shape with both of those businesses. They're doing extremely well.
spk11: Obviously, a good market for them, but It seems like the sales integration is working. Could you talk about, you know, you must be pulling in cross-selling. Where are you at with that, and what's going on with that, Jerry?
spk08: Well, we do integrations a little bit different than other companies. We operate as an operating holding company. And we do get synergies from one from the other, referrals one from the other. We have a very tight team. Our culture is throughout the company, not just in one company, but throughout the company. So that's taking place in a very nice way. And so we do get referral business one to the other. And it's working very nicely. The integration is working nicely, as are the the synergies that we promised between cryo PDP and cryoport systems.
spk11: And you would mention, Mark, I think this is probably for you. You, I think in the press release, cite a possible 21 BLA filings next year. That was about, what, 14 last time you reported. Is that a good read through or correct? Yeah, the numbers are accelerating.
spk09: I'm sorry, go ahead, Tom. It was 12 we had predicted for 2022 before, so it increased nine during the quarter. Okay, got it.
spk03: Yeah, we absolutely see an acceleration. And that comes back to what Tom and I had mentioned, you know, previously. We are starting to see a significant ramp in activity. And a lot of programs that have had delays for one reason or another are starting to pull forward and finally moving towards filing events, whether they're COVID-related or data-related or manufacturing capacity-related issues. A lot of those are finally being worked through, and we see a significant bolus of activity on longstanding clinical portfolio companies that are now getting ready to file. So we're very, very bullish because of that.
spk12: Okay, thanks.
spk03: All right, next question coming from the line of David Larson from BTIG. You may now proceed.
spk14: Hi. Congratulations on another very good quarter. Can you maybe just talk a little bit more about the supply chain pressures that you saw on 3Q? I think you mentioned that 3Q is the peak you would expect for inflation, and then In terms of inventories, have you purchased maybe a year of inventories ahead, or have you locked in pricing for a year's worth of supply within MVE? Any additional color there would be very helpful. Thank you.
spk08: Sure, David. First of all, in an environment like this, we haven't really had an environment like this for 40 years, and I remember the 70s very well, and exactly how that played out. And this is a fast-moving environment with price increases and with missed deliveries, a troubled labor market, et cetera, et cetera. Anyway, we embrace that, and we certainly are increasing our safety stocks. I can't tell you that one product, it's uniformly a year across everything, but we certainly are increasing safety stocks. We're meeting price increases head on, and we negotiate where we can. But it's very hard to get any kind of an agreement today for forward pricing for any length of time. The transportation will peak. We're already seeing signs of transportation costs coming down in a number of areas. Our folks are trained, highly trained, and we are a logistics company. So we're embracing these issues and we're working our way through it. And I think our team is doing a fantastic job in getting through it. So I don't know if that's enough color for you, but I'm happy to answer any other questions you have about it. No, that's actually very helpful.
spk03: Let me just add one element on that real quick, and that is that one of the other things we're aggressively doing is making sure that we have supplier redundancy in our platform, which gives us more flexibility as it relates to material procurement.
spk14: Right. So I think last quarter it was mentioned that MVE was operating at, like, their maximum capacity or at the highest level capacity that they had ever, and there was a second shift going on, I think, in a plant in New Jersey that So I guess we can assume that those productivity levels have been maintained. They haven't been slowed down or anything like that because of supply chain concerns.
spk08: Well, last quarter what we commented on was that that was in process. I can tell you that both plants are adding extra ships, both the New Jersey, not New Jersey, but the Minnesota. You said New Jersey. It's actually Minnesota and Georgia plants are adding additional ships. We also are doing tactical things to improve our capacity within the plant, and then we have strategic plans underway for expansion in the future. So great teamwork, great teams, and we're working down that backlog, which we need to work down so that we can give better customer response to our loyal customers. Thank you.
spk14: Just one more for me. In terms of the BLAs and the MAAs that are filed for 2021, I had thought that it was going to be 21 in 2021, and has that declined to 13 with some of those pushing into 2022?
spk09: The short answer is yes, it's come in. Some of it was pushed out. There was one that voluntarily withdrew, so it's a mix. And some of it, I think in the last quarter, we moved it from 21 down to 19 and now 19 down to 13.
spk14: Okay. And then just one more. I'm sorry. In terms of the competitive wins, you're obviously taking a lot of share. Can you give a little more detail on exactly why you're winning in the market and what differentiates you from your peers? And then are you also able to take price? Thanks.
spk08: Mark, you want to take an answer?
spk03: Yeah, I'm happy to. So why do we pull share? If you take a look at our business, we are the only fully integrated supply chain entity in the cell and gene space. We manage all aspects of the supply chain. We don't subcontract to third parties. We don't rely on third party assets to work on distribution or packaging. And so that allows us to have much more control on the quality platform and to better manage risk. That in itself is a significant driver for SHARE. The other things that we're looking at is we're the most progressive as it relates to infrastructure as an organization and capacity management. We plan in advance. We make sure that we have adequate inventory and we do aggressive forecasting to ensure we're ahead of the curve and we're not reacting to the curve so that we can support any commercial launch activity and other ramp-based activity. So all of those things are significant contributors to our share capture and provide the ability, you know, as we look at our business itself, our focus is around a platform that eliminates risk. And so that doesn't, you know, relate to, you know, commoditization of our space at all. And so that's not something that we have an interest in. We think it's a material risk to commoditize any aspect of our supply chain. We will not do that.
spk08: You know, David, you could look at what Mark just said in a different way, too, and you could think of us as being equipment, process, and information-driven. We execute all of those in a superlative way, and we strive to improve that at all times like no one else in the industry. So it's a compelling formula when a customer looks at Crowdport.
spk12: Great. Thanks again. Thanks.
spk03: All right, next question coming from the line of David Saxon from Needham. You may now proceed.
spk04: Good afternoon, and thanks for taking the questions. My first question is just on the APAC region. Can you talk about the pace at which the regulatory bodies in APAC are moving to approve these cell and gene therapies, you know, maybe relative to the pace of the FDA? You know, when do you think you'll start seeing commercial revenue there? And lastly, how important is the Chinese market specifically to reaching that five-year revenue target you put out a while back of 650 to 750?
spk08: Yeah. Mark, do you want to take that question? It's right down here.
spk03: Sure. The short answer is we're already seeing commercial revenue out of APAC, in particular out of the Japan market, the Australia market, the Singapore market. So we are already seeing commercial revenues manifesting out of the eight commercial therapies that we're supporting. We believe that that's going to continue to aggressively expand. And one of the reasons that we're looking at China as hard as we are right now is because A lot of that expansion, in particular from a portfolio expansion basis for these existing therapies, is in the China market, which obviously portends to be a significant market. But we also have substantial assets and infrastructure in countries like Korea through cryo-PDP and India, which allows us long-term to be able to expand into the vast majority of APAC seamlessly. So hopefully that answers your question.
spk04: Yeah, that was helpful. And then on the gross margin, I mean, it sounds like some of the issues you've seen in the third quarter, you know, they peaked in the third quarter, but it sounds like there's some, you know, residual impact in the fourth quarter. So from a gross margin perspective, should we be thinking somewhere in between second quarter and first half? And then I'll just ask my last question up front. Can you just give an update on the CloudSphere shipper? I think last I heard at least the launch was planned for the first quarter of 22. Is that still the case? And is that going to be a material revenue driver or just more incremental to the total platform? Thanks so much.
spk08: Let me comment on a couple of those and then I'll turn it to Robert. But yeah, the CloudSphere will be out in the first half of the year and our target is the first quarter of 2022. So and that is a revolutionary shipper. There's nothing like it in the world, and it has been well received, and we're anticipating it to be highly sought after once it's introduced into the marketplace. So we're excited about the cryosphere. In terms of margin, look, the headwinds across the world are not going to just cease in one short period of time. It's going to take, for the headwinds the world is facing, it's going to take a year or so, or a shorter time. Who knows? I mean, you can't tell exactly how that's going to unwind. We think that we have things under control. We think we have things, visibility and line of sight. So when we say, when Robert is saying it's peak, that's our best judgment at this point. But we know how to handle most of the things that we are facing, and I don't know that there's any that say most. I think there's nothing we've faced that we haven't been able to handle. So we do anticipate improvement, but I'll let Robert talk with you more about that.
spk10: Yeah, and just yet, look, as a team, we're not reacting to what's transpiring. I think even on the last call, You know, we said we're well aware of, you know, some of the challenges that, you know, the global industry is facing. So I think the takeaway really is that, you know, we have action items. We have, you know, actions underway to address, you know, the issues that we're aware of. First and foremost, again, is to drive market share, drive revenue, ensure that we have the redundancies, not to have any disruption. And we're confident that we can manage that well. It's shown by the results of this quarter. And, again, I think you can expect a strong fourth quarter moving forward as well.
spk04: Great. Thanks so much, and congrats on the quarter.
spk10: Thank you. Thank you.
spk03: Just a quick reminder for everybody, if you'd like to register for a question, you can do so by dialing 1-4. That's 1 followed by the 4 on your telephone keypad. And our next question is coming from the line of Jan V. from B. Reilly. You may now proceed. Congratulations, team.
spk02: Another outstanding quarter. Thank you for taking our questions. I have a few of them, if I may. So first, a quick follow-up on the supply chain issue. You mentioned supply chain issue with MWE by Binance. And can you comment on how does that have impact on your other segments of Binance, including cryopore systems and the cryo PDP?
spk10: I think, you know, again, what we've seen, if you look at, you know, margins and margin development, you know, the margins on the other businesses were not that significant. It was really mostly, if you look at MBE biological solutions business related to, you know, specific equipment parts and transportation costs that we experienced this higher level of pricing. That does not mean that the other business units are not impacted at all. but that's where we saw a more significant impact for the quarter, as you can see on the product revenue and related margins. So I think that's all we can comment at this point in time. We are rolling out a number of initiatives from a supplier pricing perspective, and those are underway right now. So I can't really comment further on actions that we're taking. I can state that we're still reiterating our gross margin target of 55%. Obviously, given the current circumstances, that will take some time, but we certainly believe that that 55% gross margin is achievable, coupled with a 30% adjusted EBITDA margin.
spk02: Yes, got it. That's very helpful. And maybe, can you share some progress and cases where you successfully cross-sell services within your portfolio? I would like to hear if those customers are mainly from the cryoport system part or on both sides between the cryoport system and MVE biologics. Thank you.
spk10: What we talked about in the past is really when we talked about cross-selling, it's more the synergy revenue that we're referring to, and those are revenues between cryo PDP and cryoport systems, where now both companies combined offering a more comprehensive solution, and Mark was referring to kind of the quality aspect of having everything in one hand, where we're providing a full service to our client base and to Cryoport Systems' client base. So that's well underway, and we've seen that progress over the last three quarters. That's really where we're talking about cross-selling or synergy revenues between the two companies offering a comprehensive solution.
spk03: Yeah, got it. We do also see customer referrals between the businesses as well. Yeah, that's all I have. Thank you.
spk12: Thank you. Thank you.
spk03: Thank you. All right. Our last question for today comes from the line of Jacob Johnson from Stevens. You may now proceed.
spk07: Hey, good evening, everybody. Maybe first question, just on MVE, can you talk about And kind of following up on the last question, can you just talk about your ability to sell MBE and to sell in gene therapy and maybe kind of what you're seeing in that end market in terms of the cold chain build out that's going on right now?
spk08: Jacob, we do sell into the cell and gene therapy business. We sell into biopharma and reproductive medicine. And, you know, we sell across the board in the life sciences. But at MBE, we sell through a distributor network. We don't sell directly. It's through a distributor network that we sell on a global basis. So that's how we conduct the business at MBE.
spk07: Got it. Thanks for that, Jerry. And then just on kind of like the regulatory backdrop for shipping and handling, These advanced therapies, I think a couple quarters or maybe a year ago, there were some guidelines or some best practices or some ISO something or another that came out that kind of highlighted the value proposition of what you guys do. Can you just kind of update us on anything we need to be paying attention to on kind of the regulatory aspect of handling and shipping these therapies, I guess, in the U.S. and maybe abroad as well?
spk08: Yeah, we actually participated in developing that ISO standard, and Mark has some commentary on it, I'm sure.
spk03: Yeah, we did. We contributed to the development of the ISO 21973 standard that went out in 2020. That standard is continuing now to start to intercalate into the organizations from an understanding and an application basis. You know, we're also, we also expect many of those recommendations out of ISO to move in a few year period. It doesn't happen instantaneously. It's typically a three to four year period past the ISO standard being listed to move into the regulatory bodies from an obligation standpoint. So We absolutely believe that many of the traceability standards that have been outlined there will move into FDA and European and, you know, rest of world requirements from a regulatory standpoint.
spk07: Got it. Thanks for that, Dr. Sawicki.
spk08: Hey, and Jacob, congrats. You were the first out with a note. That was really quick.
spk07: Thank you, Jerry.
spk03: All right, we have no further questions in queue. I'll turn the call back over to Jerry Shelton for closing remarks.
spk08: Well, thank you for your questions. In closing, I'd like to say that we are confident about our future, and as a mission-driven business, we will continue to focus on growth and the creation of long-term value for all of our stakeholders. The strong results we have delivered this year, the progress that we have made against our strategic plan and the initiatives, we have underway all portend a very exciting future for Cryoport. We're glad you could join us today, and we appreciate your continuing support and interest in our company. We look forward to updating you on our programs again, on our progress again next quarter, and we hope you all have a great evening. Operator?
spk03: Thank you, sir. And ladies and gentlemen, that will conclude the conference call for today. Thank you very much for your participation, and you may now disconnect your lines. Thank you.
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