11/8/2023

speaker
Operator

Good afternoon and welcome to Cryoport's third quarter 2023 earnings conference 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 the time for you to queue up for the question. If anyone has difficulties hearing the conference, please press star zero for the operator assistance. As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Frommer from KCSA Strategic Communications. Please go ahead.

speaker
Todd Frommer

Thank you, Operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events, or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and and not on the information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors, and elsewhere in our annual report on Form 10-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. Gerald Shelton, Chief Executive Officer of CryoPort. Jerry, the floor is yours.

speaker
Gerald Shelton

Thank you, Todd. Good afternoon, ladies and gentlemen. We appreciate you joining our earnings call today. With us this afternoon is our Chief Financial Officer, 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 our third quarter 2023 in-review document to our website. It can be found under Investor Relations in the Events and Presentations section. This document provides a review of our 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 the website and download it. I will provide a brief update on the business and then we'll move on to answering your questions. Earlier today, we reported third quarter results that were consistent with our expectations as discussed on our last earnings call, taking into account current and well-known global economic and geopolitical challenges. Having said that, we are continuing to see solid and sustained demand from our key life sciences and cell and gene therapy customers, despite the current microeconomic climate. What I mean by that is, when you take a close look, you will see that our quarterly results contain some very promising growth points, including a notable increase in commercial and cell and gene therapy revenue. In fact, commercial revenue increased 54 percent on year-over-year basis and 52 percent sequentially. At the same time, our bioservices revenue increased 26% year-over-year. Regarding cell and gene therapy, Cryoport systems grew 10%, both on a year-over-year basis and a quarter-over-quarter basis. All this growth was driven by the sustainable demand we saw during the quarter and that we are continuing to see from advanced therapy manufacturers. We also continue to increase the number of clinical trials supported. During the quarter, we added a net 27 trials year over year. This brings our global clinical programs to a record total of 670, with 81 of these trials being in phase three. A total of six crowdfort-supported VLA MAAs were filed during the quarter. Looking ahead during the remainder of 2023, we expect up to an additional five anticipated application filings, and one new therapy approval. We think our MBE biological solutions order intake has begun to stabilize. MBE's results this quarter were in line with our expectations, and our current guidance reflects this. During the quarter, MBE and some 70% of the world market continues to produce healthy financial metrics. but we remain quite confident about our long-term market outlook and the recovery of our China market as the country, despite its current economic woes, is a hotbed for the life sciences. Alongside our operating results during the third quarter and in the recent weeks, we have continued to execute on our corporate strategy to accelerate our long-term growth through our innovation development projects and smart strategic acquisitions and partnerships. For example, this includes our collaboration with the Cell and Gene Therapy Catapult, the premier cell and gene therapy manufacturing innovation center in Europe, to provide integrated logistic support for its Stevenage Manufacturing Innovation Center in the United Kingdom. Further, this partnership from its location on the Catapult site will provide other opportunities within the Stevenage Bioscience Cluster. This collaboration establishes our UK Logistics Center which will, our first UK logistics center, which will further support our European expansion. We recently completed the acquisition of Tech4Med Life Sciences, a technology spinoff of the Technical University of Darmstadt located in Darmstadt, Germany. Tech4Med provides next generation pharmaceutical supply chain visibility by integrating advanced condition monitoring cloud and artificial intelligence solutions. We are excited about integrating Tech4Med's cutting-edge technology for comprehensive market monitoring in real time across all crowd pool companies. By doing so, we will expand our digital supply chain solutions offerings and be able to provide our life sciences clients with even greater condition monitoring options, logistics management capabilities, and customer support. With these latest developments, In our leading market positions, we have even greater belief that our long-term growth prospects are solid. There is no other organization in the life sciences with the breadth of capabilities Crawford has in providing robust, dependable, end-to-end supply chain solutions. Today, Cryo PDP is the world's third largest specialty courier serving the life sciences, covering over 220 countries and territories. MBE Biological Solutions is the world's largest manufacturer of vacuum-insulated products. products and cryogenic systems and is the preferred brand for academic government and life sciences companies worldwide. Cryoport Systems supports approximately 70% of all the cell and gene therapy clinical trial market. And as we continue building our global supply chain solutions, that share continues to grow even in a challenging environment. And cryogen is one of the industry's most trusted and specializing in the secure storage of biological specimens and supporting MD Anderson, Baylor, Texas Children, ATARA, WANZA, START, and many others. Trial Court is poised to capitalize on the continued growth of the life sciences and especially the cell and gene industry as more therapies make their way toward commercialization over these coming years. Even with today's economic and geopolitical environment, the cell and gene therapy industry is expected to grow at a 10-year compounded annual growth rate of approximately 20%. This concludes our prepared remarks. Now, I'd be happy to take your questions. Operator, please open the lines for questions.

speaker
Operator

Thank you. Ladies and gentlemen, we will now conduct the question and answer session. If you have a question, please press star followed by the number 1 on your touchpad. If you wish to cancel your request, please press star 2. Please ensure to lift your handset if you're using a speakerphone before pressing any keys. Your first question comes from Paul Knight from KeyBank. Your line is now open.

speaker
Paul Knight

Hi, Jerry. Congratulations on the quarter. The Vertex sickle cell anemia therapy, I think you've mentioned that in the past. What level of involvement will you have there is my first question. And then the second question is, if you look back on the NVE, which had its period of softness, but seems to be stabilizing, was it kind of overstock globally? And then what portion was just tighter CapEx budgets? Thanks.

speaker
Gerald Shelton

You know, Paul, if I understood that, I'll take the second question first and then turn the first question to Mark on Circles South. You know, MBE is in a solid position. I mean, it's hard for us to dissect exactly how much was overstocking and how much, you know, exactly what happened in the market except for the conservatism and capital expenditures amongst our customer base. And then, of course, we have the pullback in China, which we think is stabilized. So we think we're in a stable position going forward on MBE. Its order intake is stabilized. It looks like it's in good order. And hopefully China's hit its bottom and will be coming back up. there couldn't be much further impact on us. Our China revenue in total this year, or for this quarter rather, is around 4%. So it's not going to be any kind of a significant China effect going forward from this point forward. And we think it's stable. Does that answer your question, Paul?

speaker
Paul Knight

Yeah, very useful. Thanks. I mean, I guess the bottom line is, you know, we're getting past it.

speaker
Tom

Yeah, and maybe let me just add real quick to MBE because I think sometimes people overlook that. In spite of the revenue level right now in Q2 and Q3, if you look at our product revenue for Q3, the product revenue gross margin is at 45%, and the MBE business has been very profitable, driving good, positive, adjusted EBITDA and cash flow.

speaker
Paul Knight

Okay, great. Yeah, thanks.

speaker
Gerald Shelton

And your first question was on sickle cell, and Dr. Suricki will answer that.

speaker
Suricki

Yeah, Paul. So we actually had six DLA filings of portfolio companies that were completed in the quarter, which includes Aviona, Immunity Bio, Rocket, the CRISPR Vertex program, as well as the label expansion for Breonzi, all of which are playing a role, and obviously they're approved. in the commercial launch activity of it. We can't disclose exactly what we're doing due to confidentiality, but we will play a role in all of those products, assuming that they come to fruition. So the story is even broader than just the CRISPR Vertex product, because we're seeing an acceleration in the commercial filing and activity space, which we think is going to continue to drive that strong performance we had in our commercial revenue for the quarter.

speaker
Paul Knight

And is that filing data in the prior press releases, Mark?

speaker
Suricki

In prior press releases as it relates to?

speaker
Tom

No, that's the answer. We haven't disclosed it until this report. It's in the review that we posted on our website.

speaker
Suricki

Sorry for questioning so much front end.

speaker
Paul Knight

So we have six BLAs in Q3, 5, and Q4. What do you think we'll end up with in a range of this year versus last?

speaker
Suricki

Tom has that data handy. He tracks it really detailed. Tom, do you got those stats in front of you?

speaker
Tom

Let me make sure I understand your question. Are you asking how many filings for the year or how many potential approvals for the year?

speaker
Paul Knight

I think filings is a common terminology you use, Tom, right? So the 11 we will have here in Q3 and Q4 and then The question really is the number of BLAs and MAAs total this year versus last.

speaker
Tom

It is higher, although it is, to be candid, lower than what we were forecasting at mid-year. A few filings have slipped out into 2024, where we expect 20 filings now that we have visibility on in 2024. So there were about four or five, if I remember correctly, that slipped from 2023 into 2024. On the approval side for those in 2024, we do have four already that have PDUFA dates or FDA dates for decisions in early 2024. OK, thanks.

speaker
David

Your next question comes from David Saxon from Needham.

speaker
Operator

Your line is now open.

speaker
spk10

Great. Good afternoon, guys. Thanks for taking my questions, and congrats on the quarter. I did want to just ask a follow-up on the MBE order comments. So what exactly are you seeing stabilized? Like, are the orders looking to be flat more sequentially? Are you seeing things have improved to be flat on a year-over-year basis? And then is this, you know, worldwide, including China, or specific to certain regions?

speaker
Gerald Shelton

David, thanks for the question. I mean, we monitor a lot of metrics at MBE, and what I was referring to is the order intake is stable out. It's flattened out, and we think that it will continue to be stabilized.

speaker
David

Okay. All right.

speaker
spk10

So I guess stable flattened out from the second quarter into the third, into the fourth. And then I'll just ask my... Okay. Okay. That's perfect. Thank you. And then, you know, you obviously noted strength in commercial revenue. That was up fairly significantly in bioservices solutions. And you said in the document you posted that it continued into the fourth quarter. So can you characterize what you're seeing? Are trends accelerating into the year end? Are they, you know, just kind of stable but continuing to be strong? And then are there any, you know, reasons why that wouldn't continue into at least the first half of next year? Thanks so much.

speaker
Suricki

Go ahead. Yeah, so I'll comment on that. On the bio services side, things are very, very consistent and strong. You know, we obviously opened the two new facilities in Houston and New Jersey last year. We've actually onboarded 29 new clients into those facilities over the last 18 months, which is a very, very strong base. And this is in addition to very, very strong demand from the cryogene asset as well. So that's very, very positive. On the commercial side, as Tom had mentioned, you know, filing activity is very strong. You know, we see line of sight on a significant increase in the number of approvals. And, you know, multiple of these products should be fairly decent volume, which will continue to contribute to, obviously, our contribution from a commercial revenue standpoint into 24th.

speaker
Tom

And maybe just to add, if you look at the Q3 performance in commercial revenue, we'll always have some timing where you have a little bit more revenue in one quarter than the other, but we do expect to see growth overall ongoing in commercial revenue with that in mind that you'll have some quarters that are higher just because of maybe a greater portion of product-related sales versus service-related sales.

speaker
David

Okay, great. Thanks so much for taking my questions. Your next question comes from John Sarbier from UBS.

speaker
Operator

Your line is now open.

speaker
spk03

Good evening. Congrats on the quarter, and thanks for taking the question. You know, just maybe to dive in a little bit more on the commercial revenues, you know, nice growth in the quarter, 50% year over, over 50% year over year. I guess any additional details I guess you can provide there on this? Is this, you know, additional services you have with some of the previously approved product, or is there a ramp from some of the newly approved products here? Just any additional call you could provide on that.

speaker
Suricki

Yeah, the bottom line is we saw contributions from TOLC. You know, you're seeing additional uptake in revenue acceleration out of our portfolio of the existing products, and obviously our support of the Sarepta product has also been a nice contributor to that number for the quarter.

speaker
spk03

Thanks. And then I guess just any color on cryo PDP in the quarter and how the rollout is going there in the U.S.?

speaker
Gerald Shelton

The cryo PDP is doing well. The rollout is, you know, we had to make some adjustments in the U.S. and we've made those adjustments and we see that rollout being a continuous smooth rollout.

speaker
spk03

Thanks. And I guess last one here on my end. You know, just Any additional call you provide on like demand trends across large pharma, maybe emerging biotech? I know the total clinical trials are up year over year, but have you noticed any just changes in customer behavior than given some of the funding environment or just broader macro pressures?

speaker
Gerald Shelton

You know, as I said during our last quarter's call, I think that the development of this industry is, is similar to biologics. And if you look at biologics in the way it has since butter was in the beginning and then leveled out and everyone today would want to be in biologics, it's in the pharmaceutical business. It's a fantastic business and a larger business. And we're on the same track. We're in the beginning phases of the development of this industry. We're developing solutions to answer questions in this industry, to answer answer needs in this industry and to help it propel and move forward. And we think we're on the same track as biologics, if not better than that track.

speaker
David

Got it. Thanks for taking the question. Your next question comes from Jacob Johnson from Stevens.

speaker
Operator

Your line is now open.

speaker
spk15

Hey, thanks. Good evening. Congrats on the quarter. Thanks for taking the question. Maybe not to belabor the point, but just one more follow-up on the commercial revenue. Really strong growth. Dr. Sawicki, if I heard you correctly, it sounds like Sarepta was some portion of that. At the risk of asking a question you may not want to answer, but any way to tease out how much Sarepta was a contribution to growth underscores?

speaker
Suricki

Yeah, we don't break it out on a client-specific basis, but it was a meaningful contribution. I'll leave it at that.

speaker
spk15

Okay, that's helpful. And then maybe a bigger picture question just on IntegraCell. I think that's a platform you guys have continued to build out over the last year. I'm just kind of curious where that stands on a revenue basis, and as we head into next year, what's the opportunity around that offering?

speaker
Gerald Shelton

I'm going to start and let Dr. Saliga then take over, but the IntegraCell was started during the last year and it's progressing, but this is a novel solution for the cell and gene therapy industry. It's something that's needed in the industry. It will have to be not only the plants built out and finished, and Mark can comment on that, but then they will have to be validated and customers will then do their audits. But we already are seeing demand coming in. This is a customer-driven endeavor, so we know it's going to be successful. Mark?

speaker
Suricki

Yeah, just to add on that, so the site in Houston is construction complete. We're just going through all the validation activities as we speak. If the site in Belgium is nearly construction complete, we'll be running a couple of months behind the site in Houston. As Jerry mentioned, we're already seeing very strong interest. We've already had a significant number of clients come through the facility, even during construction. And we also already have a robust pipeline as it relates to folks that are evaluating it to be able to step into their clinical and commercial opportunities. So when the facilities come online in 24, we believe that there will be a very, very nice and quick uptake with that asset as it comes online.

speaker
David

Got it. I'll leave it there. Thanks for the questions. Thank you, guys.

speaker
Operator

Your next question comes from Tia Savant from Morgan Stanley. Your line is now open.

speaker
Tia Savant

Hello. This is Yuko on for Tejas. Thank you for taking your question. You talked about MBE demand starting to stabilize in China. Are you seeing effects of anti-corruption initiatives still continuing in the region? And what do you think needs to happen?

speaker
Gerald Shelton

I'm sorry, you're coming through on the phone very weak. I didn't really get your... Sorry about that.

speaker
Tia Savant

Is that a little bit better?

speaker
Gerald Shelton

Yeah, that's better. That's better. Thank you.

speaker
Tia Savant

Okay. You talked about MBE demand starting to stabilize in China. Are you seeing effects of anti-corruption initiatives still continuing in the region? And what do you think needs to ultimately happen to begin seeing recovery of that market?

speaker
Gerald Shelton

Well, you know, we're not experts on the internal workings of China and what's on the administration's mind. But what we can tell you is that there has been some reserve as a result of the Foreign Corrupt Practices Act. And so people are lying low. They don't want to get caught in investigations and that sort of thing. So it is suppressing the market. And hopefully that will open up very shortly. And President Xi is taking initiatives within the economy to stimulate it. But It's hard to predict exactly when those initiatives will have some impact. We know one thing. We can't discount China because it is a hotbed of activity for the life sciences, and we intend to participate there.

speaker
Tia Savant

Great. Thank you for that, Culler. And then a separate follow-up. Could you elaborate more on the Tech4Med life science acquisition? How does their condition monitoring with AI differ from capabilities offered by Cryoport, and how do you envision incorporating their condition monitoring capabilities into CryoPortal and SmartPak2 condition monitoring system?

speaker
Gerald Shelton

I'll start, and then I'm going to turn it over to Mark for further comment. But Tech4Med is truly a natural acquisition with true strategic impact. The technology that's been developed by Tech4Med over the last eight years of its existence is is fantastic technology. It's complementary to much of the technology that we have within Crowdport or have underway at Crowdport. And it will boost it. It will actually boost it. It will have synergistic value. It has a number of features that are going to have significant impact, certainly on Crowdport, and we think on the market in the future. So with that, I'll turn it over to Mark to make further comments.

speaker
Suricki

Yeah, thanks, Jerry. Yeah, Jerry's exactly right. You know, it's a very complimentary product to our existing SmartPak 2 condition monitoring platform. It'll provide us more depth with different service levels and competencies from obviously high-end real-time monitoring as well as, you know, all the way down to a disposable, you know, data loggers for one-way or unidirectional transit packaging. So it's a very complimentary product for us. you know, the product suite itself will dovetail very nicely into what we've built, you know, within our existing portfolio services.

speaker
Gerald Shelton

I'll just add just a couple of things, just a couple of things on that. Look, you ask about AI. We've been using AI for a number of years. AI is an important technology. It's advancing very quickly. They have that capability. And the other thing is, Tech Permit is very communications friendly. It's enhanced beyond anything on the market today, and we'll be taking advantage of that, and you'll see it.

speaker
David

Great. Thank you. Thank you.

speaker
Operator

Your next question comes from Yuanqi from B. Riley. Your line is now open.

speaker
Mark

Thank you for taking our questions. Great to see the strong revenue from commercial cell and gene therapies. We heard some of the cell and gene therapy manufacturers signaled weakness in 4Q. How do you see this trend so far in this quarter and the next couple of months? And then I have a follow-up question.

speaker
Suricki

I'm sorry. You've seen some of the commercial CDMOs doing what?

speaker
Tom

Some of the cell... Yeah, I'll take it, Mark. You're right. There were mixed quarters from our commercial customers. Some of them had revenue below street expectations. Others exceeded it by a lot, namely J&J Legend and Sarepta. It is going to be a mixed bag in Q4 based on what they're telling the street. So we can't really comment more on their forecast.

speaker
Mark

Got it. And then a follow-up question is related to the tech format acquisition. Does it mean now CryoPort would expand the capability to provide logistics to pharmaceuticals outside of the cell and gene therapy?

speaker
Suricki

Yeah, the short answer is yes. It's complementary to our cryo PDP. logistics offering, and it will provide them additional and enhanced competencies as it relates to data monitoring for areas outside of the cell and gene space.

speaker
David

Got it. Thank you.

speaker
Operator

Your next question comes from David Larson from BTIG. Your line is now open.

speaker
David Larson

Hi. Can you talk about large freezer shipments within MVE How is that progressing? Has growth picked back up or is it steady, stable?

speaker
Gerald Shelton

Yes, David. The orders for freezers are back on trend. And I said on a stabilized basis. And there was a clarifying question asked earlier about second, third, first and second quarter. And so orders have stabilized across the board. The patterns are stable.

speaker
David Larson

Okay. And then how many therapies, cell and gene therapy products would you expect to get approved each year, roughly speaking? I think you were supporting around 15 last quarter. And I mean, your commercial revenue, it's pushing 10% of total revenue, I think. I'm just trying to get a sense for how much of your total revenue you think that could become like into next year and the following years, it seems like it's growing pretty rapidly.

speaker
Gerald Shelton

All right, I'll start to answer the question, David, but then Mark and Tom should add their comments as well. Look, the whole, this is no surprise. I mean, commercial therapy is what it's all about. And, you know, we support the most trials, but that's in order to get to the commercial level. you know, get these therapies to the commercial arena. And as we start to improve, you know, through 10 therapies per year, it's certainly commercial, the commercial revenue is going to dwarf depending on, you know, the number of patient potential for the indication, but it's going to dwarf, you know, the revenue from clinical trials and that's coming. That's coming. That's what we're building the company for. That's why we're investing in all of these initiatives for the future, because we have to be there ready to support the industry as it commercializes. Mark, do you want to add to that?

speaker
Suricki

Yeah, the numbers actually, we're currently supporting 12 commercial products. And Jerry's exactly right. Our entire strategy has been to capture the clinical space and retain it during commercialization. You know, Gottlieb said back in 2019 that he anticipated by 2024 to 2025, 20 commercial approvals a year. And we're actually starting to see line of sight on that number. And so, you know, we're very excited by that, especially because we're supporting such a large percentage of the clinical space. We wholeheartedly anticipate and expect to retain the vast majority of those through commercial. And, you know, we're building out our infrastructure to support that scale.

speaker
Tom

a little bit for you. So it's 12 commercial today. Hopefully two more will get approved before the end of the year. That would bring us to 14. Those two do have PDUFA dates or FDA dates before the end of the year. And then we have six more we're forecasting to commercialize next year. That would bring us to 20 total if we're right. Of those six that we're forecasting for next year, four already have PDUFA dates in the first, a little over the first four months of the year. And hopefully that number will grow above six, but that's what we're seeing today.

speaker
David Larson

How much revenue do you think those six could contribute to the business?

speaker
Suricki

We haven't disclosed what that anticipated number is, but obviously we expect the commercial growth number to be disproportionate to our overall growth number over time.

speaker
David

Okay, great. Thanks very much. Congrats on a very good quarter. Thank you. Your next question comes from Brandon Coyard from Jefferies.

speaker
Operator

Your line is now open.

speaker
spk09

Thanks for taking the question. Maybe for Robert. Circling back to the comment that you guys said you saw the strong cell and gene therapy demand continue here into 4Q, is it fair to assume that commercial revenues will be up sequentially in 4Q versus 3Q?

speaker
Tom

No, I think, yeah, the way you have to look at it is really, obviously, longer term, we expect to see very solid growth on the cell and gene therapy side for commercial revenues as we add more commercial therapies to the portfolio. If you look at, you know, quarter and sequential growth, just because of the early stage of this revenue stream, you will have, you know, just timing-wise, different revenue streams. So we expect to see growth year over year, clearly, but Sequential growth really depends a little bit on the type of services we provide, the type of accessories we provide. So that may vary between quarter to quarter sequentially. But ultimately, again, we look at growth year over year ongoing.

speaker
Suricki

Yeah, that's why we always say to you guys, you know, look at commercial on a rolling basis. You know, we recommend looking at a four-quarter rolling average, and that's where you should see very consistent growth is when you look at that because there is some volatility quarter to quarter based on the timing of certain products and services that we're doing from a commercial standpoint.

speaker
spk09

I appreciate it. And then I guess any more call you guys can add on the 27 new trial ads, you know, pretty impressive just given kind of all the headlines around there of funding. um you know this healthy clip for you guys is that mostly existing customers building up the portfolio anything you know competitive wins maybe you know i haven't talked about this in a while but maybe folks shifting from homebrew on the earlier stage side to you guys just kind of talk about who um is kind of driving those 27 net new ads for you guys thanks yeah so um

speaker
Suricki

I can do it, Tom. It's fine. Yeah, so, you know, of those, we're still seeing above-average volatility on removals. So that, you know, we're actually seeing net increases that are higher than that. But with the volatility in the space, we're seeing still a fair deal of trials that are either being completed or terminated or suspended on a quarter-by-quarter basis. And so for Q3... We added 28. We had 26 that wound down. Of those, 15 were completed, nine were terminated, and two were suspended. A fairly large percentage of those, and I don't have the number in front of me, are our new clients. So we've been very successful pulling share on the new client basis, as well as retaining in our existing trial base with our existing clients.

speaker
David

Tom, I'm sure you want to add anything else. No, you covered it, Mark. Thank you. Thank you. Your next question comes from Richard Baldry from Roth MKM.

speaker
Operator

Your line is now open.

speaker
Rich

Thanks. You've had a spate of new product and service sort of upgrades and enhancements and rollouts lately. I felt like a lot of your R&D projects sort of come to fruition, but this quarter R&D is up about 21% sequentially. You talk about sort of where those incremental investments are going. Is this, you know, was there anything one time in there? Is this sort of a new sustained or extensible level? How do we think about that?

speaker
Suricki

Robert, do you want to take that?

speaker
Tom

Yeah, absolutely. Look, if you look at our R&D expenditures, you know, we have a number of initiatives that are ongoing. Some of them have come to fruition, such as, you know, the Cryoport Elite Shipper that's being used for Sarepta and ultimately available to other clients in the cell and gene therapy space. Others are still ongoing. We recently launched the CryoPortal 2. We have some additional activities related to that CryoPortal 2 logistics management system. We're also working on condition monitoring systems, sky tracks. So there are some ongoing investments and R&D activities related to those initiatives that we expect to complete during 2024.

speaker
Gerald Shelton

And in addition, Rich, we have the global supply chain network, which continues to progress nicely, but it certainly is not up to its full maturation. And so, all in all, it's progressing the way we expected, but it is robust.

speaker
Suricki

Yeah, we're actually seeing a very nice monetization of the services that have launched. I mean, you guys, you know, seeing that the two new facilities, the one in New Jersey and the one down in Houston, Texas, Those facilities are now averaging one and a half audits a week. You know, we put 20 million new bioservices clients in those facilities over the last year. I mean, so it's substantial. And that's a lot of privation of those investments.

speaker
Rich

And there's a lot of talk about the private equity and VCs pulling back on their portfolios. You maybe talked broadly about the acquisition environment. Are you seeing more opportunities? Do you think valuations are finally coming into better zones for you to go after?

speaker
Gerald Shelton

No, Rich. We actually don't look at it that way. We look at things that fit in our strategy and fit to where we're going, and we don't see any big change in that area. Okay.

speaker
Rich

And lastly, looking at the balance sheet, you took out some of the the convertibles early and how to gain on that and did buybacks at the same time. How do you think about the capital structure as it sits today? You know, was it just opportunistic on, on the convert side? Do you think that's a strategic, you'd want to keep that up if at all possible? You know, how, or how, what level of cash would you be comfortable with aside from doing the buybacks?

speaker
Gerald Shelton

Which in today's environment, it's a, it's, it's a question that we constantly are, are asking ourselves and we're constantly monitoring. But, you know, we have the geopolitical situation. We have, we have an industry that's developing very rapidly. We have a lot of things going on. There's a lot of dynamics. We do have acquisition opportunities that come up occasionally. We want to be prepared to move on those when they do come up. So, you know, managing the cash and managing the buybacks is, is, is, is a, an artful thing and it's one that we do look at on a constant basis, but we're measured in that. We are open and we're very open to all the information that comes in and we make our decisions. So there's not much else I can say about that except we're constantly looking at it.

speaker
Tom

Yeah, maybe I can just add some data points to it. If you look at, you're absolutely right, we did buy equity in the past and in this just recent third quarter, We did repurchase some of the convertible debt, some of the 2026 convertible debt. So we have actually a gain of about $6.2 million in the income statement, a gross gain, from that repurchase, really buying the converts at about $0.80 on the dollar. So we are monitoring that. With the repurchase program, we still have about $36 million remaining to deploy under that program. And so we have some of the ability to repurchase additional convertible debt or equity if we think the timing is right and it's warranted.

speaker
David

Great. Thanks. Next question comes from Punit Sudha from Learing Partners.

speaker
Operator

Your line is now open.

speaker
spk02

Hi, guys. Thanks for taking the question. So, first one on... Wondering if you're getting any feedback from some of the commercial providers, commercial therapies capacity. We're hearing sporadically with different drugs that the supply is constrained on the cell therapy side. I'm sure you have seen that too. So just sort of trying to get a sense of is that gating some of the growth in the near term and how do you see, what are you hearing on your end?

speaker
Suricki

Yeah, I actually think we're getting over the hump on that. To be honest, I mean, the nature of conversation is shifting from manufacturing capacity now to patient accessibility. And that's one of the reasons that we moved upstream with the IntegraCell platform that we're building out is to really drive that patient accessibility and help facilitate scalability as it relates to ensuring that the patients that want the therapy can get the therapy. So I think that's going to become a smaller issue. A lot of the contract manufacturers now don't have these two- and three-year backlogs on product requirements or manufacturing backlogs. So I think the manufacturing capacity issue, we've largely caught up to it, I think.

speaker
spk02

Okay. And then on cryo PDP and MVE, obviously a large portion of your revenue is still So, just wondering if you can provide some guideposts as you're thinking about, you know, sort of 2024 in those businesses. Anything you could provide would be helpful. Thank you.

speaker
Gerald Shelton

Yeah. Robert, do you want to take that?

speaker
Tom

Yeah. Just in terms of the 24 outlook, we will provide, you know, guidance and a more detailed review of the 24 outlook, you know, at our year-end earnings call. Look, we've talked about the Cryo PDP business. They have expanded their geographic platform. They've been very strong in Asia, PAC, and Europe. We fell a little bit short on the U.S. side in terms of driving the revenue synergies between Cryo Persistence, Cryo PDP. That is advancing, and we are taking steps to really enhance that, and you'll hear more about that over the next weeks and months. So that's how far we can go at this point in time, but we'll certainly provide a little bit more of a detailed outlook for 24 at our year-end earnings call.

speaker
spk02

Okay. And then if I could ask about, you know, there is, you know, some companies are seeing more expansion in EU versus US in terms of therapies. I'm just wondering if you're seeing any logistical challenges with all the, you know, Obviously, there's the war in Europe, and then now the Israel-Gaza situation. So just wondering if you're seeing any disruptions in logistics on that front.

speaker
Gerald Shelton

Nothing of significance right now. We've had disruptions in the past, but they were minor, and there's nothing of any significance whatsoever at this point.

speaker
David

Got it. Okay. Thanks, guys. Thank you. Thank you.

speaker
Operator

Your next question comes from David Larson from BTIG. Your line is now open.

speaker
David Larson

Hi, one more. It looks like your SG&A costs came in maybe up 20% year over year. All the companies that I cover have talked about sort of paying aggressive attention to their cost structure. Do you have any thoughts there, Robert or Jerry? And it just seems to me like there's a lot of EBITDA potential in the business as it stands now, just any thoughts around, you know, cost containment efforts that I think a lot of folks have been sort of seeing recently. Thanks very much.

speaker
Gerald Shelton

Yeah, I'll begin, and then Robert can conclude on that question, David. But you're right. There is a lot of potential in the SG&A, and that SG&A is inflated because of the number of projects that we have going on. These are all customer-driven, market-driven projects with great potential, but they do have an impact as they're under development on the SG&A, but the potential is enormous. Robert?

speaker
Tom

Yeah, I will say maybe first with some of the earlier investments we've made that we talked about. Some of those investments are starting to pay off now. We talked about the biostorage, bioservices revenue that grew 26%, and then also obviously building our core solutions in terms of the revenue growth on the commercial side. Norworthy there is the initiative that we have related to our CryoPort Elite Shipper supporting Sarepta's commercial launch. So these are initiatives that you've seen over the last years in terms of building out some of these competencies. And then we talked about building out the overall global infrastructure. And really, if you look at the market that we're in and the expected growth that we're seeing, Just based on discussions with the clients that we're currently serving in clinical trials and commercial launches, we do know that this will ultimately drive significant revenue. And you're absolutely right. As you see that revenue grow and as you see us leveraging the assets and the capabilities, specifically in the cell and gene therapy space, you'll see that EBITDA margin grow with that as well. So we are very mindful of cash. We're very mindful of spending. and ensuring that we have the right RIs. It's on our minds and certainly on the investors' minds, as you stated, but at the same time, we see a significant opportunity for us really to further bolster our leadership position and to capture more wallet share from these customers that are poised to grow quite significantly over the next years.

speaker
David

Thanks very much. There are no further questions at this time.

speaker
Operator

Jerry, please proceed with the closing remarks.

speaker
Gerald Shelton

First of all, I want to thank all of you for your joining the call today and the robust question and answer period. There were good questions and gave us a chance to talk about some very important things. In closing, our third quarter results were in line with our expectations, showing some growth aspects, particularly in commercial revenues. At the same time, Crowdport has continued to execute on its corporate strategy, increasing its market presence and capabilities through meaningful partnerships and acquisitions. By continuing to execute on this strategy, we believe Crowdport will emerge as an even stronger company that is well-positioned to achieve long-term profitable growth. We thank you for joining us today. We appreciate your continuing support and interest in our company, and we look forward to updating you on our progress again for the fourth quarter of So have a good evening. Thank you very much.

speaker
Operator

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

Disclaimer

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