Cryoport Inc (CYRX) 2020 Q4 法說會逐字稿

Thank you for standing by. This is the conference operator. Welcome to the Cryoport, Inc. Year-end 2020 Earnings Call. (Operator Instructions) I would now like to turn the conference over to Todd Fromer, Managing partner of KCSA. Please go ahead.

Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on 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. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Thank you, Todd. Good afternoon, ladies and gentlemen. We appreciate you joining our earnings call today. With me this afternoon is our Chief Financial Officer, Mr. Robert Stefanovich; and 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 2020 year-end review document to our website. It can be found under the Investor Relations section in the Events and Presentations section. This document provides a review of our recent financial and operational performance and 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.

As with previous quarters, on this conference call, we will provide you with a brief general update, and then we will move to addressing your questions regarding our company's results. 2020 was a historic year for Cryoport, culminating in a transformational fourth quarter during which we continued to effectively execute our strategy and significantly strengthen our global platform by closing on 2 milestone acquisitions. These strategic acquisitions provide our client base with the ability to leverage our ever-expanding supply chain continuum as we extend the breadth of their relationship with Cryoport, whom they have grown to trust with their irreplaceable cold chain therapies and materials.

But that is not all of it happened. Let me set the stage by a brief review of some of our accomplishments during the year. The following points. We raised a total of $390 million through a $115 million convertible debt financing and by issuing a $275 million convertible preferred to Blackstone Group to support the acquisitions of CRYOPDP and MVE Biological Solutions as well as for the further build-out of our competencies.

We acquired CRYOPDP, established a foundational network of logistics centers in EMEA and APAC. We acquired MVE Biological Solutions, the #1 producer of cryogenic systems worldwide, further establishing Cryoport as the #1 end-to-end provider of temperature-controlled supply chain solutions for the life sciences industry. With the 2 acquisitions, we have expanded our global presence to 30 locations located in 13 countries. Our network gives us a new advantage when serving global multinational customers and also provides redundancies and backup that reduces supply chain risk for our customers.

We initiated the build-out of 2 additional fully integrated bioservices and logistics centers, both of which will be online in 2021. We opened our first fully operational jointly operated logistics center for Cryoport Systems and CRYOPDP in Osaka, Japan. We renewed and extended our commercial relationships with Novartis and Gilead. The number of cell and gene therapies we support grew to 6, including the global launch of BMS' BREYANZI.

On the R&D front, the highlight of 2020 was the expansion of our Cryoport certified cool line of shippers and solutions to support all temperature ranges from minus 80 to control room temperature, including the Cryoport Elite Shipper an advanced, proprietary and scientifically designed Ultra Cold Shipper and our revolutionary and patent-pending Cryosphere Shipper expected to be launched during the second half of 2021.

We ended with cash and cash equivalents and short-term investments of $93.3 million. And in January 2021, we completed an underwritten public offering led by Morgan Stanley, Jefferies, Leerink and UBS raising net proceeds of $270 million. As a result of these strategic milestones, Cryoport is now positioned to further leverage our global platform with a family of companies that provide mutually reinforcing global, market-leading temperature control supply chain solutions for the life sciences.

Our financial results reflected this strong performance and our continued momentum in these markets we serve, especially in cell and gene therapy. Total revenue for the fourth quarter of 2020 increased to $48.4 million compared to $9.2 million for the fourth quarter of 2019, a year-over-year gain of 423%, with organic growth of 36%. The total revenue for the full year 2020 increased to $78.7 million compared to $33.3 million for the full year 2019, a year-over-year gain of 132%, with organic growth of 26%.

In summary, Cryoport delivered. We surpassed our business and financial goals for 2020 despite the challenges of the environment due to COVID-19, staying true to our course of creating leading new market -- new markets through technology innovation. We focused on differentiated solutions, services and products suited to the complexities and pressures of the life sciences temperature control supply chain challenges.

And with that, I'd like to turn this call over to the operator to open the lines for your questions.

(Operator Instructions) Our first question comes from Puneet Souda with SVB Leerink.

So first one is, could you elaborate on MVE, if there was a step down sequentially from the third quarter to the fourth quarter? It just wasn't clear in the release. And then can you elaborate on the COVID contribution from any vaccines during the quarter as well?

Yes, Puneet. Actually, there was a step-up in the fourth quarter for MVEs. MVE met our expectations and is doing very well, and we'll continue to do so. We have a nice backlog and the transition has been very smooth. In terms of contribution from COVID, we -- as you know, we support about 16 -- is it 16?

29.

It's 29. 29 Clinical trials related to COVID. Some of those are therapies, and some of them are cures. And we do some re-icing or replenishment for coldness in some parts of the world. But we don't play a main role in COVID. We are a cell and gene therapy company, and we've stayed focused on that competency.

So just following up on that. I mean, should we not expect any COVID contribution for the entire year despite you being involved in a number of trials and therapeutics here?

It will be minimal Puneet. It won't be anything major for sure.

Okay. And this question is maybe for just Robert as well. In terms of -- I know you haven't traditionally provided guide, but at this point in time, we -- the business is fairly large with MVE and CRYOPDP total revenue. So if you could maybe just help us elaborate -- help us understand if the combined MVE and CRYOPDP or separately, should they be growing at least 10% or higher? And wondering if you are comfortable with the consensus, which is very close to about $200 million for the full year? Is that something that we could expect going forward for the full year?

Yes. I think -- thanks, Puneet. I think we've talked about it in the past a little bit in terms of the revenue synergies and the growth potential for MVE Biological Solutions and then also CRYOPDP and CRYOPDP in specific with the synergy rated together with Cryoport Systems. So I think in general terms of analyst expectations for the year, we're comfortable with analyst expectations. In terms of the growth and the change in growth rate from the historic growth rates, that obviously will happen over time. So you'll see on the actions that we're taking bear fruit throughout the year to change the profile that they've historically had, and a big driver of that is obviously the cell and gene therapy space and some of the synergies that we've already identified.

In terms of giving guidance, that's something that we do discuss on a regular basis. At this point in time, we're not giving guidance. And the real reason around that is because of the dynamics in the regenerative medicine space and cell gene therapy space. That continues to be our core focus and this market is at the very early stages of growth. But we'll certainly revisit that over time as the market grows and matures, to see what type of guidance we'll give going forward.

Okay. And just clarifying the first question, Robert, that I add in MVE, there is a step down in gross margin. So I just wanted to find out, was that largely a step down in gross margin and the corporate gross margins, is that largely due to MVE? And was there a step down or a step up actually from third quarter to fourth quarter sequentially for me?

I think if you look at MVE and CRYOPDP, their margin profiles are different. If you look at the legacy business, the legacy business has been performing on par with the past. And then you have the margin profiles of CRYOPDP, which is lower and MVE which is slightly lower, drive revenue -- drive the margin for Q4 down.

Again, that's another area, that, we believe, we can achieve higher margins, specifically because if you look at, for example, CRYOPDP that is now moving into the cell and gene therapy space, which is a higher value, kind of, high-quality and touch solution. There's opportunities for margin increase in the service offering that CRYOPDP brings to the table.

Okay. Got it. And last one, if I -- and I'll hop back into the queue. I'm wondering if you're expecting any impact from ZYNTEGLO this year?

The impact for ZYNTEGLO will be minimal on our overall revenue. It is an orphan product. So it doesn't have significant volume at this moment in time. It's -- the impact of, obviously, the notice is out there to us. It doesn't look like it's more of a patient specific. It's not a therapy specific issue. And so based on what we've heard through the Leerink conference and others by the CEO of bluebird, they don't anticipate it being a long-term issue and neither do we.

The next question comes from Brandon Couillard with Jefferies.

Jerry, if we look at the commercial biopharma revenues, they're about flat, I believe, in the fourth quarter sequentially. First, how did that compare to your expectations? And then secondly, now that you have 5 commercial programs there. You started last year with just two. How should we think about the growth of this line item in '21?

I'll let Mark -- why don't you take that?

Yes. So what we're going to see is all of these therapies operate in a stepwise fashion. So the early launch, obviously, of the Novartis and Kite products, that initial transition over the last 3 years, they -- in the geographies that they were supporting, they started to hit a patient absorption of their manufacturing capacity so the overall growth rate on those has normalized a bit.

With TECARTUS coming online in the middle of last year as well as BREYANZI from BMS which is a larger volume product, they'll have a much larger contribution to growth this year. And so we do anticipate that our overall growth rate, as it relates to commercial, will pick back up significantly this year versus what it was at the end of last year.

Brandon, just to correct you, there's 6 commercial therapies we're supporting not 5 now. There's the Orchard product out there also that was approved at the end of last year.

Yes. But I mean, both the bluebird and the Orchard products are orphan products, so they're smaller volumes, so they won't have a market of impact. But BREYANZI and the TECARTUS launch will have a bigger impact on, obviously, top line for commercial.

In terms of the new logistic centers that you opened in Japan and Singapore, were those pre-existing PDP locations? Have you built out liquid nitrogen capabilities there? And you talk about any incremental planned investments in other logistics centers you expect to make over the course of '21?

Well, Brandon, they both are new locations. We relocated our Singapore operation with a CRYOPDP. And then the Osaka, Japan location is a new location. They both, of course, are outfitted to handle liquid nitrogen and all Cryoport products. And then, of course, we have the 2 supply chain centers that are being developed in the -- in Morris Plains and in Houston. And we will be developing over this next year, more logistics locations, but it's premature for me to tell you exactly where they are, but we will keep you up-to-date on those -- on that development.

The next question comes from Andrew D'Silva with B. Riley Securities.

I hope everyone's well. I'm still going over the 2020 interview doc. But could you just start by just educating me on what support entails for COVID-19 vaccines and therapeutics. So historically, with logistics, for example, you manage the entire process and are largely still a logistics provider. How do we think about Cryoport's legacy business, Cryogene, CRYOPDP as it relates to that. And then kind of segment that into 2 parts, particularly interested if the therapeutic or the vaccine are actually cell and gene therapy, should we think about that as more of a legacy where you entire -- control the entire process too?

Andy, I want to make a few -- first of all, this is a good question, and I'll make a few comments, and I'll turn it to Dr. Sawicki. So first off, we are not focused on COVID vaccines. Our focus is on cell and gene therapy and within the life sciences. All of our skill sets and capabilities are definitely transferable and could be used in that way. But when you think about vaccines, you're thinking about massive distribution and you're thinking about the manufacturers, you're thinking about economies and the way they get those things -- those vaccines out. We're dealing with quite -- something that's quite different.

We're dealing with irreplaceable cell and gene therapies. And our services are not the least expensive on the market and even though our skill sets are totally transferable. And then the fact of the matter is, we have consulted with a number of states and authorities, including work speed, on the project. But we don't expect anything significant coming from COVID in terms of betting the ranch or betting our future on COVID. That's not our game. Our game is cell and gene therapy.

As I said, we do support 26 trials in cell and gene therapy. Some of those are therapeutics and some of those are cures. And with that said, Mark, do you have anything to add to that?

Yes, Jerry. So it's actually 29 programs. And largely, our support comes out of the opportunistic relationships that we have with our existing client base as well as folks that have come in. And so in many cases, they'll ask us to maybe do some sort of storage aspect of drug product from a clinical or vaccine basis. It may be something -- some limited distribution requirements for high or challenging distribution lanes. Or it could be things like re-icing, right? Or replenishing dry ice in the field. Like Jerry said, our focus is not on capturing a very low margin, very large volume business line. That's not our -- in our wheelhouse. Our focus is on those ultra-high touch requirements and support elements.

So how about if it is a cell and gene therapy, for example, that is also a COVID therapeutic? I guess that's really where we're headed down the road.

If there was a cell and gene therapy that had a cryogenic storage and distribution requirement, the likelihood of us being involved will be much higher.

And we are involved with -- but it's just not pervasive, and it's not with the ones that have been released, Andy.

Maybe I can help you out -- this is Tom, sorry to barge in, but the cell and gene side is not on the vaccine side, it's on the treatment side, trying to keep those folks that have COVID from passing away or staying in the hospital for a lengthy time. So that's where you've seen, I'll call it, the cellular play. The vaccine side is either like the J&J, the traditional vaccine or an MRNA vaccine, but those are in high-volume in cell therapy.

Okay. Useful color. And then just looking at the fourth quarter and then you kind of comparing it to consensus and the previous question, you almost hit $50 million for the quarter. Consensus is at $200 million for the year. Historically, the cadence has been, as the new year starts and progresses into material growth of the fourth quarter of the previous year, is there any reason to think that should deviate this year? Or was there any significant kind of onetime revenue benefits during the fourth quarter of '20 that we should be kind of thinking about as we layer on new initiatives and build out our revenue for 2021 and '22?

Yes. Thanks, Andy. Look, overall, I think we were very satisfied with the Q4 revenue results. We had strong growth in revenue for our Cryoport legacies, our Cryoport Systems and Cryogene. And we had strong results from CRYOPDP and MVE Biological Solutions compared to their revenue historically and also in terms of what our expectations were. So that just first and foremost, especially looking at the first quarter after a transaction is completed, I think those are very good results.

In terms of looking into 2021, the only thing that you should have in mind is there's a little bit of seasonality in some of the businesses. So obviously if you look at MVE, there may be some seasonality in terms of the purchasing. But ultimately, as we said, in terms of revenue growth, we expect revenue growth, where we're comfortable with the projections from the analysts. And that's all I can say at this point.

Okay. Last question, just as it relates to commercial revenue. I know that you were talking about this in previous questions. But should we expect most of the growth from commercial revenue in 2021 to come out of established products, primarily KYMRIAH and YESCARTA? Or should we expect most of the growth year-over-year from commercial launches that are really just starting like YESCARTA and Bristol Myers Squibb products?

So there's 2 factors. So factor one is an existing product line is expansion of their global capacity, right? So if you look at Kite Gilead, they're launching a new facility in Maryland -- Frederick, Maryland this year. If you look at Novartis, they're launching a new facility in Stein, Switzerland this year as well as announced manufacturing partnerships in Australia, for example. So based on when that capacity comes online, the legacy products should see increasing revenue associated with volume around that capacity increase. You then combine that with the -- obviously, the new product launches, BREYANZI being obviously the most evident from a volume-based standpoint, that will definitively have an increasing contribution to the overall number.

The next question comes from Richard Baldry with ROTH Capital.

If we looked at pro formas of the 3 separate entities or prior to integration, 2 kind of approached, call it, a breakeven zone. One MVE was with pretty solidly adjusted EBITDA positive. So against that backdrop, can you talk about how much the current quarter or December quarter profitability sort of inhibited by integration issues, how quickly the company could sort of resurface the level of profitability it would have had in sort of 3 entities? Or are there some initiatives for spending and growth that kind of should take us backwards a bit first as a combined company before we move forward again?

Rich, that's a really good question. And I want to make a few comments and then turn it to Robert. As I've said before, we certainly didn't buy these companies for what they had been doing. We bought them for what they will do and what they do for Cryoport and carrying out its mission. Both companies, if you look at -- they were part -- both companies, both CRYOPDP and MVE, were a part of very large companies and as such, they were insignificant.

And in fact, we know there not much attention was paid in terms of direction, support, et cetera. And we were able to peel them out that we were able to get a spin off. Now within Cryoport, MVE and CRYOPDP are very important. They're strategic, as a matter of fact. And so -- and they will play a role in Cryoport as we march forward in cell and gene therapy and the cell and gene therapy advance. So they're going to be performing differently than they've ever performed in the past. And all of that is, as Mark said earlier, it takes time or Robert said that. But it does take time to make these transitions.

But we will make those transitions, and you'll see all the metrics moving in a positive and upward direction. You'll see the top line growth rate accelerate, you'll see the margins change because they will be participating with Cryoport in a much more important way in markets that they heretofore have either not participated in or participated on a very limited basis. So with that, I'm going to turn it to Robert.

Yes. And just to clarify, again we say it takes time. This is just life sciences and it is regulated. We're obviously moving forward very aggressively. If you look at Q4 and the full year of 2020, we had acquisition and integration costs of roughly $12 million for the year and $4.4 million for the quarter. That includes also a step-up in inventory that really only impacted Q4 and will not impact the financials going forward. So if you eliminate some of those additional charges, the intangibles, or if you just look at the adjusted EBITDA alone, you'll see that for the year, we were around breakeven.

But for Q4, we were about $3.9 million in positive EBITDA. So you already see some of that profile pushing through to the bottom line. I think going forward, as Jerry mentioned, that certainly, there will be some investments made to make sure the platform is ready for a more aggressive growth profile. But I think we're also very keen on maintaining the high EBITDA contribution that MVE was able to drive historically and continue with a very similar profile.

On CRYOPDP, we already talked about the growth driver being their focus on cell and gene. They're, to some extent, also piggybacking on Cryoport Systems, allowing us to offer a broader solution to our existing client base in the cell and gene therapy space and kind of the higher-margin synergistic revenues that we'll be bringing in, in 2021.

Maybe just to finish up that point then. Is there ways that you'll be able to communicate with investors sort of over the near term, intermediate term about successes you're having accelerating the 2 acquired entities or pulling them into the cell and gene therapy space, so that while we look at a blended growth rate that will come down just mathematically, we can start to understand the successes you've had integrating the two? Or will it be pretty difficult to sort of break away any key metrics that kind of help us along that path?

Rich, you'll see that in the -- certainly in our overall results. But the way we manage the business is it won't lend itself to just going after individual components of the business. There are -- it is a family of companies and we do operate and we do have metrics and so forth. But we're also careful and mindful of the environment that we're working in. So we'll keep that in mind. We'll do what we can do to help you understand that in the future, but I'm not sure exactly what those measures would be. Robert, do you have anything to add to that?

No. I think we understand that investors want to understand how the acquisitions are progressing and what impact they have on Cryoport consolidated. So we'll certainly look at indicators and means to be able to drive that theme as well. Especially in the early stages post the acquisition. We do want to make sure that investors understand the value that these acquisitions bring to Cryoport, and so we'll look at indicators that will provide that information.

The next question comes from David Saxon with Needham.

My first is just on the margin profile of the combined business. You've talked about expecting to see a dip in the gross margin, and we obviously saw that this quarter. But you have the expectation of getting to your longer-term goal of 60%. So first, I guess, can you just help us think through the cadence to that 60%? And then on the operating margin, you're targeting $20 million in cost synergies from the CRYOPDP acquisition. So should we think about that as a linear path over the next, call it, 5 years or so? And then in 2021, specifically, the consensus is, I think, around a low to mid single-digit operating margin. So is that something that's reasonable in your view?

A number of questions there. I appreciate it. Look, I think in terms of the gross margins, I mean you already framed it correctly. We didn't expect a combined lower margin because of the different profiles that each of the companies bring to the table, and we'll seek to driving that up. It will happen over time. And this is not something that's going to happen within the next few quarters.

But certainly, you'll be able to see some margin improvements based on the client -- our client base as well as the overall value of a solution that we're bringing to market. I think that's probably on the margins as much as I can say at this point in time.

I think there's one other thing that ties in there, Robert, also that we identified, David, $100 million of synergies over 5 years. And while those synergies will not be linear, I mean, there's nothing in this business of the life sciences is linear. But we are on a pathway to achieving that already just in one quarter and things are moving in that direction. So we will achieve that over the next 5 years, that $100 million of synergy.

And you'll also see CRYOPDP moving more into the cell and gene therapy space, as we -- as they benefit from being a part of Cryoport, Inc., and you'll see some of the same thing happening at MVE. So again, as to Robert's point, everything in this business has to be validated. So let's just say that CRYOPDP is working with Cryoport Systems on a particular project, it still has to be validated. Just because it's working with Cryoport systems, doesn't mean it's going to be instant. So it has to be validated.

And so all of that takes time. It's just -- there's just a requirement in the life sciences for surety and for making sure that efficacy is delivered and conditions are controlled. I hope that makes sense.

Yes. And then just to add to that, in terms of that line of thought, what that does create, though, is since Cryoport Systems, as an example, is an accredited client partner, we've been bringing CRYOPDP into our client base quicker than we otherwise could. And then because life sciences is regulated, once you're in, you're in, it's a very strong relationship and strong retention, as we've shown in the past with our current client base.

Got it. That's helpful. And any comment on consensus being low to mid single-digit operating margin?

Again, I think we're obviously assessing kind of our path forward from my perspective, without giving guidance, we certainly expect the margins to improve. And overall, we're -- again, we're comfortable with the analysts as a whole.

David, one other thing, though, you really should look at us as market leaders and continuing to be market leaders. So our #1 initiative is all around market share and being -- and just -- and anticipating market needs, just enough that we're always the leader in the market. So look at market share, first. We're not racing. We will be profitable, but we're not racing to profitability. We could be profitable instantly at any time, but it's all about market share and keeping up with the growth and opportunities in the marketplace.

Got it. That's helpful. And then when you bought MVE, I think you said about 70% of their sales were through distributors. So can you talk about any plans about converting that to more of a direct sales channel? And if that is the case, how much of a margin benefit that would have or price?

We don't have plans to convert the distributor network into a direct sales force. I mean, that distributor system is extensive. It's an extensive and sensitive nerve network for the company. We will enhance it, but we will not replace it.

Okay. Very clear. And sorry, if I missed this in the document posted, but can you just talk about the outlook for Cryoport for BLA and MAA filings for 2021 and potential cadence of approvals?

Yes. So as we had mentioned, we're currently sitting at 6 approved therapies that we're supporting. We anticipate upwards of another potentially 21 filings in 2021. And we had a total of 7 that were filed in the second half of last year -- all of last year, sorry, yes. So the cadence is definitely starting to pick up.

The next question comes from Jacob Johnson with Stephens.

Maybe first question on MVE. If I'm not mistaken, I think there's some new products coming from them. Can you just remind me what these were? When they will launch? And maybe how much they could add to growth at MVE?

Well, the new products that you're referring to is the Vario. The Vario is a multiple temperature freezer, it can dial from minus 20 all the way down to minus 196. And the second product you were talking about is Fusion. And Fusion is a self-sustaining liquid nitrogen powered freezer that never has to be refilled or replenished with liquid nitrogen, and we have another size of that coming out very shortly. And we haven't disclosed the impact of either of those on our revenue yet.

Okay. Got it. And then, Jerry, you've got, I think, something north of $300 million of cash, you're acquisitive last year. Should we expect M&A in 2021? And maybe if so, could you just remind us of your M&A criteria and any capabilities you'd like to add?

Well, what you should expect is that we continue to carry out our mission. We established our mission 6 years ago, our strategy 6 years ago, and we continue to carry that out and that's what you should expect. And so that will be a combination of robust organic growth and acquisitions if they are available. It takes a seller and a buyer. And so we can't always map out when acquisitions will be available. We do have a robust pipeline of acquisition candidates. And we are discussing relationships with people all the time, but that can go all the way from customers to strategic partnership to acquisition. So that's about as much as I can tell you about that. The kind of acquisition that we are looking for is both in the vertical and the horizontal.

So we'll look at adjacent spaces to packaging and logistics expertise and software or informatics and we'll look at those in more depth. We'll look at tactical acquisitions that could make sense to us and as well as strategic acquisitions. But we want them to be well run. We want them to be accretive. And we want it to be a situation where management wants to stay on with the companies and continue to propel the companies that hopefully are already on a growth profile.

So we're looking for healthy accretive companies to add to our portfolio when they meet our requirements for carrying out our strategy.

The next question comes from Mike Gokay with KeyBanc Capital Markets.

Starting off with Mark, with the '21 filings expected this year, I'm looking at the company at list and it seems like there's a fair amount of companies without a currently approved product on the market. So how many commercial -- new commercial therapies do you expect to support versus kind of market expansion of your currently supported products?

That's difficult to absolutely ascertain. Like you said, I mean, a lot of these companies in this space don't have a historical track record of product approvals. However, that's offset by the FDA being a little bit more inclined to move forward with these types of projects and programs based on the nature and the criticality need in the space. From our perspective, we anticipate multiple additional approvals, but I can't really speculate beyond that for you. Because it's -- obviously, we don't control the FDA, and we don't control those specific entities. All we can do is ensure that we're fully prepared to support any filing and commercialization activity that they engage on their behalf.

Mike, I'd probably also add, I wouldn't be surprised if some of them got absorbed by larger pharma or biopharma.

Very helpful. And then Jerry, or this may be for Mark, too. But talking to the new shipper launch, I think that will be more targeted to gene therapies in the minus 80 C range. Can you kind of just talk to the uptake of that? And is it targeted towards more of your existing clients who are going to shift over from the lower storage temperatures? Or is it kind of new customer acquisition there?

It's kind of interesting. The product was actually designed and developed in conjunction with one of our clients, who helped -- who is specifically in the gene therapy space and took a look at the market and felt that there was nothing sufficient on the market to be able to support their activity on a very aggressive portfolio from a rollout basis. And so we work with them jointly on the developmental aspects.

The product itself will be significant and differentiating into the market space and is designed to support actively both viral vector distribution as well as gene therapy clinical and commercial distribution.

Our next question comes again from Puneet Souda with SVB Leerink.

I appreciate that you answered a number of them. And obviously, a number of efforts underway on your new product launches and temperature ranges. What I think I wasn't clear on is the split of MVE into animal health and MVE separately. So you did almost $7 million in the animal health. And Robert, please correct me if I'm wrong on that. I just wanted to get a quick follow-up from you on how sustainable is that animal health business?

I mean, this is a sizable business now and given the potentially competitive nature and the lower margin nature of it, how sustainable is this business under MVE longer term?

Well, Puneet, this is exactly where MVE started its business is in animal husbandry. It's a highly sustainable part of the business. It's been this way for something like 50 years. So it's -- we're very confident and comfortable with that part of the business. We dominate that part of the business, having an extremely high share of that market. So we're comfortable with it.

And just to add, I think the animal health space is one area, where you will see synergy activity between Cryoport Systems and MVE over time based on the nature of both relationship to that market.

This concludes the question-and-answer session. I would like to turn the conference back over to Jerrell Shelton for any closing remarks.

Thank you very much, operator, and thank all of you for your questions. It was a terrific dialogue, and we appreciate them. We've entered 2021 and the strongest position we've ever been in, with an unrivaled leadership position in animal health, reproductive medicine and especially biopharma pharma markets. As a result of our ingenious team of people, investments and expanded footprint, we have a very broad reach within the industry and are dedicated to continuously scaling our business with focus and purpose.

I'm confident that we have the unique capabilities, competitive moat needed to extend our support and commercial regenerative medicine therapies around the globe as those anticipated therapies come to market. To further advance our leadership position within the industry, we are continuing to invest in enhancing our platform by developing best-in-class, highly differentiated and specialized solutions that are redefining the temperature-controlled supply chain for the life sciences industry and providing the best services possible to our clients. Overall, we are delighted with the way the company performed in 2020 with 36% organic growth in the fourth quarter and 26% for the full year.

We delivered robust growth, and we continue to see increasing traction in the regenerative medicine industry as we closed the year, supporting a total of 528 trials and 6 commercial therapy agreements. Strategically, our 2 acquisitions position us well for excellent growth in 2021. And with robust indications across the life sciences, we anticipate that 2021 will be another excellent year for our company. We want to thank you for joining us today. Until the next meeting call, we bid you a good evening.

This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.