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Earnings call: Cryoport maintains guidance despite Q1 challenges

EditorAhmed Abdulazez Abdulkadir
Published 08/05/2024, 07:38 pm
© Reuters.
CYRX
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Cryoport, Inc. (CYRX), a global leader in temperature-controlled supply chain solutions for the life sciences industry, held its first quarter earnings conference call, revealing a mix of headwinds and strategic optimism. Despite a disappointing start to the year, particularly in the life science products segment, the company remains confident in meeting its full-year revenue guidance of $242 million to $252 million.

CEO Jerrell Shelton emphasized the strength in the company's cell and gene therapy client momentum and the growth of BioStorage/BioServices revenue, projecting an acceleration in revenue for the remainder of the year.

Key Takeaways

  • Cryoport's Q1 results fell short of expectations, especially in life science products.
  • The company anticipates revenue improvement throughout the year and maintains its full-year revenue guidance of $242 million to $252 million.
  • There is positive momentum in cell and gene therapy clients and growth in BioStorage/BioServices revenue.
  • Cryoport supports 675 global clinical trials, viewing this as a long-term growth opportunity.
  • Initiatives are underway to drive positive adjusted EBITDA and cash flow, including workforce reduction and leveraging shared services.
  • Cryoport ended the quarter with a healthy cash balance of $448.5 million.

Company Outlook

  • Cryoport expects MVE revenue to be flat in 2024 with improvements in 2025.
  • The company's revenue growth will primarily be driven by its services offering.
  • Plans are in place to begin manufacturing freezers in China by mid-next year to cater to the local market.
  • Cryoport aims to achieve a gross margin of 55-60% and an adjusted EBITDA margin of 30%.

Bearish Highlights

  • Life science products revenue was lower due to decreased demand for MVE Biological Solutions' Cryogenic Systems, particularly in China.
  • Biologistics revenue was weak due to trial terminations, but the company expects improvement with new programs.
  • There was a notable drop-off in Q1 performance in the Asia-Pacific region.
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Bullish Highlights

  • BioServices saw a 9% year-over-year growth in the first quarter.
  • The onboarding of 27 new clients in new facilities hints at future revenue potential.
  • Integration of Bluebird Express with CRYOPDP is proceeding well, with three new logistics centers opening in the US.

Misses

  • The company noted volatility and churn in the trial business, though new startups and clients are entering the space.

Q&A Highlights

  • Executives discussed the impact of petroleum prices on margins and their cost reduction efforts.
  • The company is not in a hurry to invest in manufacturing in China but has plans for mid-next year.
  • Revenue from BioStorage/BioServices and IntegriCell is expected to pick up over time.

Cryoport's first quarter has been challenging, with particular softness in demand from China impacting the life science products segment. However, the company's strategic focus on cell and gene therapy clients, along with the growth of BioStorage/BioServices revenue, provides a solid foundation for expected revenue acceleration later in the year. With a strong balance sheet and ongoing cost control initiatives, Cryoport is positioning itself to leverage the expanding cell and gene therapy industry and achieve its financial goals in the coming years.

InvestingPro Insights

Cryoport's first quarter has indeed shown a mix of challenges and strategic initiatives aimed at leveraging growth in the life sciences industry. To provide a deeper financial context for these developments, here are some insights based on real-time data from InvestingPro:

  • The company's market capitalization stands at $806.3 million, reflecting the scale at which Cryoport operates within the temperature-controlled logistics space.
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  • Cryoport's Price to Earnings (P/E) Ratio is currently negative at -7.49, with an adjusted P/E ratio over the last twelve months of -12.61. This metric indicates that analysts do not expect the company to be profitable this year, aligning with the company's own earnings call insights.
  • Despite the lack of profitability in the short term, Cryoport's liquid assets surpass short-term obligations, suggesting a degree of financial resilience. This is a critical factor as the company navigates through the current challenges and works towards its revenue goals.

InvestingPro Tips for Cryoport also reveal that the stock has experienced significant price volatility, with a large price uptick over the last six months of 59.69%. This could signal investor confidence in the company's long-term growth trajectory, especially given its focus on the cell and gene therapy sector, which is reflected in the company's strategic optimism.

For readers looking to delve deeper into Cryoport's financials and future prospects, InvestingPro offers additional tips and metrics. By using the coupon code PRONEWS24, readers can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to a total of 7 InvestingPro Tips for Cryoport, which can offer a more comprehensive view of the company's performance and outlook.

Full transcript - Cryoport Inc (CYRX) Q1 2024:

Operator: Good afternoon and welcome to Cryoport Fourth Quarter and Full Year 2023 Earnings Conference Call. All participants will start in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded. I will now turn the call over to your host, Todd Fromer from KCSA Strategic Communications. Please go ahead.

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Todd Fromer: Thank you, operator. Before I get started with this, I just want to correct the records. This is the Cryoport first quarter earnings conference call. Before we get started, 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 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 results 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.

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Jerrell Shelton: Thank you, Todd. Good afternoon, ladies and gentlemen. Thank you for joining our first quarter earnings call today. With us this afternoon is our Chief Financial Officer, Robert Stefanovich, 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 first quarter 2024 and review document to our website. It can be found under Investor Relations in the News and Events section. This document provides a review of our financial and operational performance and a general business outlook. If you've not had a chance to read it, I would encourage you to go to our website and download it. I will provide you with a brief update on our business and then we will take your questions. For the first quarter 2024, we continued to experience a difficult environment globally. Our quarterly results were disappointing across the board, particularly our life science products. However, as we stated when we initially provided our annual guidance, we anticipate our total revenue will progressively improve throughout the year and we maintain our full year revenue guidance of $242 million to $252 million. I am sure some of you are asking what makes us confident. Well, there are several things. For example, despite the near term challenges, we are still quite positive based on the momentum we see – we're seeing from our cell and gene therapy clients and from the growth of our BioStorage/BioServices revenue. If you look at our results, you will see that our first quarter commercial therapies grew – rose 9% while BioStorage/BioServices revenue also rose by the same amount. Both these services areas should continue to be growth drivers for Cryoport in 2024 and beyond. We're also encouraged by new clients slated in the biopharma market and some positive signs recently in the cryogenic systems market. As I indicated, our life sciences services revenue growth for the first quarter was softer than anticipated, increasing 3% year-over-year. There is, however, a bright spot as the cell and gene therapy market seems to be gaining some momentum again. To date, this three year-to-date – to date this year three new therapies have been approved, three existing commercial therapies were approved to move to an early line of treatment and two therapies were approved to expand their label or geographic territory. By combining the expected revenue ramps of existing and new commercial therapies, we believe we should see revenue acceleration from our cell and gene therapy clients over the remainder of the year. Currently, we think an additional 16 global regulatory filings will be completed before year end. As of March 31st of this year, Cryoport supported a total of 675 global clinical trials, a net increase of 23 clinical trials over the same time last year. As of the quarter end, 77 of these trials were in Phase 3 along with 312 of them in Phase 2. As we have said before, our clinical trial portfolio represents a substantial long term revenue growth opportunity for Cryoport as more therapies advance through the clinical trials toward commercialization. Our outlook for the rest of the year with commercial therapies look strong, with potentially five additional new therapy approvals and three additional label or geographic expansions. Turning to our life science products. Similar to last quarter, this business revenue was lower than in prior years. This was due to decreased demand for MVE Biological Solutions' Cryogenic Systems. This in turn was attributable to a continued slowdown in capital equipment investment that began last year. Although global in nature, as we have reported previously, the most severe pullback in demand continues to be in China. While we expect MVE's Cryogenic Systems' sales to be challenged throughout the remainder of this year as biotech funding government budgets and academic budgets are constrained, we expect to see gradual improvement in demand in the ensuing quarters. MVE is a well managed business and we want to remind investors that even in this difficult time it continues to produce free cash flow for our company. MVE is the leading manufacturer of cryogenic systems worldwide and we're confident in the long-term prospects of our products business. And when demand normalizes, and we believe it will, we will benefit from our position as the global leader in this space. In summary, and to put it plainly, there is simply no other company with the extensive resources Cryoport has in providing a full array of innovative, reliable, end-to-end supply chain solutions to the life sciences. With advanced services, products and information systems focused on reducing risk and located in 50 locations in 17 countries, Cryoport is well prepared to support the expansion of the life sciences and especially the growing cell and gene therapy market. Based on our clients forecast and fueled by industry indicators for cell and gene therapies and the life sciences, we continue to build out services, products and infrastructure to prepare ourselves to provide comprehensive and dependable supply chain support for these life saving treatments. However, considering the current macroeconomic challenges and their impact on our financial results, we are implementing a number of initiatives to drive toward positive adjusted EBITDA and cash flow in the near-term. These include improved alignment of our global organization, reduction in our workforce, leveraging lower cost shared services, refining and reprioritizing planned initiatives and delays in capital spending as a result of reprioritization, all of which should positively impact the second half of 2024. We are mindful of our need to maintain a strong balance sheet to support our future growth and we ended the quarter with $448 million of cash balance – $448,500,000 cash balance. This concludes my prepared remarks. Now, we're going to be happy to take questions from you. Operator, please open the lines for questions.

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Operator: Thank you, ladies and gentlemen, we will now conduct the question-and-answer session. [Operator Instructions] Your first question comes from Tejas Savant from Morgan Stanley (NYSE:MS). Your line is now open.

Unidentified Analyst: Good afternoon guys. This is Edmund on for Tejas. Thank you for the time. First question could you guys provide some more color on how things played out at MVE? Where do customers stand today in terms of their need to expand their freezer capacity? And what do order books look like heading into the second half?

Jerrell Shelton: MVE?

Robert Stefanovich: Yes.

Unidentified Analyst: MVE.

Jerrell Shelton: Okay. So can you just repeat that question again, please?

Robert Stefanovich: Just one second.

Jerrell Shelton: Just one second.

Unidentified Analyst: Sorry, Jerry, this is Edmund. But the question was could you provide some more color on how things played out at MVE this quarter? Where do customers stand today in terms of their need to expand their freezer capacity? And what do order books look like heading into the second half of 2024?

Jerrell Shelton: Okay, that's a good question. And look, MVE tracks its orders and talks with its distributors and its key – its direct customers on a regular basis. There's simply been some pullback in funding in government and institutions and business, and that seems to be breaking. We seem to be – and we do know that in the last half or the second half of this quarter, we – this year, we will have – it looks like we have orders lined up for large pharma and for mid-sized biorepositories. And we think that there's some government spending that will be in the last half. So we think we'll have a progressive improvement in the MVE in the second half of the year.

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Unidentified Analyst: Got it.

Jerrell Shelton: The pullback in the MVE, the China – in China – China is continues to be in recession. And we do not expect China to improve for the remainder of this year and probably into the next year. There's been a reduction in biotech funding and there's been some breeder programs instituted by the government and all of that's affected our business. However, we do have initiatives to compete within China on a very effective basis. I want to remind you though, China only accounts for about 5% of our total revenue at this point.

Unidentified Analyst: Got it. That's very helpful. And then a higher level question. Some of the traditional logistic companies, such as UPS, have recently expressed an interest into expanding into the healthcare vertical. Now, are there any opportunities for a company like Cryoport to work with those providers? Or do they represent more of a medium term competitive threat to the business model?

Jerrell Shelton: Over the recent time, UPS has become more of a competitor, or tried to at least. But we worked with the integrators on a regular basis and we have for twelve years since I took over the company, we've had strategic relationships with them, which we've talked about on a frequent basis. In some cases, we worked more closely than in others. UPS has been the most aggressive through their purchase of Marken, but they don't really pose a tremendous threat to us. We still use them as an integrator in many of our services.

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Robert Stefanovich: They also use our equipment sets on a regular basis in conjunction with programs that they're supporting through their healthcare vertical.

Jerrell Shelton: That's an important point. That's MVE equipment.

Unidentified Analyst: Got it. And then one housekeeping question for the model. What percentage of the product revenue is from MVE and what percentage from legacy Cryoport Systems?

Jerrell Shelton: Robert?

Robert Stefanovich: It's really – yes, if you look at the product revenue, it's really the vast majority. So, in excess of 95% of the revenue is related to MVE cryogenic systems.

Unidentified Analyst: Got it. Super helpful. Thank you for the time.

Jerrell Shelton: Thank you.

Robert Stefanovich: Thank you.

Operator: Your next question comes from Matt Stanton from Jefferies. Your line is now open.

Matt Stanton: Hi, thanks. Appreciate the color on focus near-term on EBITDA and cash flow. It sounds like you have a number of initiatives in motion around that. Just help us quantify what the impact could start to look like to OpEx as we move into the back half of the year. Just trying to get a better understanding of what total cost savings or improvements we could start to bake into the P&L here. Thanks.

Robert Stefanovich: Yes, thanks for the question. Look at the current time, we obviously just provide guidance related to our annual revenue. But with that said, I can provide a little bit of information. Overall, we have been and are taking continuously actions in the review of our initiatives of our CapEx spending, pushing out some of the CapEx spending that is not driving kind of near-term revenue or is not critical to our near-term initiatives. If you look at the overall operating expense, a couple of things. One, we've been building out our infrastructure over the last couple of years, as you know, and we're looking to see leverage of that infrastructure and capabilities that we built out. We expect to have that substantial compete in 2026. As revenue grows, we're going to see better operating leverage of the overall infrastructure that we set up. In terms of the specific question in modeling out the second half of the year, I would expect a drop in operating expenses. I can't tell you exactly the percentage will provide some more clarity there. But certainly we do expect to see an impact in the second half on the operating expenses.

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Matt Stanton: Okay, thanks. That's helpful. And then maybe back over to MVE. You talked about how sales kind of remain challenging there and a gradual improvement through the year. I think prior you guys had baked in kind of flattish growth in MVE for the year. Just given kind of the slower start, should we still expect MVE to be flattish in 2024? Or is it down for the year? And I guess if it is now down in 2024, what other areas are potentially offsetting that to reiterate the guide for the full year?

Robert Stefanovich: No, Matt, I think you can expect MVE to be flattish for 2024. And so you'll see that improvement in the last half, which will create that. And then I think we will have some progression in 2025. Look, we ran into a situation where the market pulled back in the second half of 2023 severely and that probably had to do with some extra capacity buildup from COVID plus the economics, economic situation, which caused people to pull back on budgeted and governments pulling back and so forth, but some of that's freeing up. At some point, you have to have more capacity. So we do think it will be flattish in 2024 and improving in 2025.

Jerrell Shelton: And the driver, really, for the revenue, especially in the second half of the year, is related to our services offering and revenue.

Matt Stanton: Okay, great. And maybe just one last quick one. The Phase 3 trials dropped to 77. I know you expect some normal kind of fallout in there. Any more color you can provide on just the gross and net numbers for Phase 3 in the quarter? And did it have any impact on 1Q revenue given those programs are generally a bit more meaningful than some of the earlier phase programs? Thank you.

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Mark Sawicki: Yes, we're still seeing a lot of churn as it relates to clinical trial activity. So if you drill into the flat sequential quarter, we actually saw 42 trial terminations. And 20 of which were completed and 22 terminated. Those that were terminated in many cases were due to cash. Of those, obviously, you saw a drawdown of the phase – some of the Phase 3 trials. We also added back 42 programs. Obviously, there is a lag period associated with those as they get up and running. But we did see an impact on a couple of terminations in Phase 3 that did show some – obviously that that had an impact on where we thought we were going to see some accretive activity there that was relatively flat. But the good thing is that the new programs that are starting are really diversified and will start to contribute in the coming months.

Matt Stanton: Thanks. That's helpful. Appreciate it.

Operator: Your next question comes from Puneet Souda from Leerink Partners. Your line is now open.

Philip Song: Hi, this is Philip on for Puneet. Thank you for taking my question. Maybe just the high level kind of question. Just coming off a softer first quarter, you got an implied ramp in the second half that's a bit steeper. Can you just maybe give a bit more color on sort of the levers that gives you confidence to reiterate your guidance? Kind of if you expect MVE to improve sequentially in the second quarter, or if that's still hasn't bottomed out, or just kind of what are the different levers that will take us to the low end versus kind of like the high end of the guidance? Thank you.

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Jerrell Shelton: Sure. I'll start the answer and then Robert and Mark may want to chime in with some other thoughts, but our outlook is based on the trends that we're currently seeing industry wide, as well as what we specifically are seeing from our cell and gene therapy clients. So if you take these factors into consider – taking those factors into consideration, and we're confident as one can be given the current economic and the geopolitical landscape. There are a number of clients with commercial therapies that are forecasting a second – a strong second half ramp. And we also are seeing a number of new therapies approved recently, and their ramp should contribute to our revenue growth later this year. And then there is the biotech funding increasing dramatically in quarter one and then – and we should see some impact from that later this year. And we're having new products and services launched throughout the year, which will bring in new revenue. So all in all, we believe that each of these business – each of our businesses will grow in 2024. As highlighted in the press release, our service business should lead the way and I think Robert mentioned that a little bit earlier. So Robert, would you like to add anything?

Robert Stefanovich: No, I think you mentioned most of it. We do expect in progressive improvement and then you absolutely write specialty in the second half. And if you look at some of the core revenue drivers, commercial revenue, BioStorage/BioServices revenue, and even maybe clarification on commercial revenue, you look at the commercial revenue growing 9% year-over-year. But we all said, take a look at the trailing twelve months revenue because you have some lumpiness there in terms of timing. So you look at twelve months over twelve months for Q1 over the trailing twelve months last year it grew about 27%. So if you look at that, plus the additional BLA filings, MAA filings and expected approvals that we see this year, you'll see continuous momentum that will keep driving the services revenue to meet or beat our revenue guidance for the year.

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Mark Sawicki: Yes, let me just add to that. Obviously a lot of our commercial folks have come out with earlier line approvals. Obviously BMS and JNJ, Sarepta might have a significant expansion coming out after the end of the second quarter, all of which should contribute to increasing activities that relates to commercial. And then obviously the recent approvals for Iovance, CRISPR, Vertex (NASDAQ:VRTX), Bluebird, ImmunityBio, and Atara are also going to start to contribute in a more meaningful way.

Philip Song: Got it. That makes sense. Thank you. And then maybe just one follow up housekeeping question. I guess I know you guys don't have too much exposure to China, but have you thought about kind of how much risk there is with the BIOSECURE Act and any retaliation to that for your business, any potential disruption there?

Jerrell Shelton: Yes, we have. We thought quite a bit about it and we studied China quite a bit. Look, China is the second most powerful country in the world and has more trading partners than the United States, an extremely important country, and it's not going away. And we have an investment in China. We have a plant in China, and that plant is staffed by some very capable people. And we have an initiative to compete better in China, given President Xi's buy in China, what's made in China. And so we'll be manufacturing freezers there in the future for that Chinese market. But the Chinese market is – there are some risks, but you have to pay attention to the rules of the game and play there. We're not going to go back to the thirties and forties with China. China is here to stay and we have to learn how to work with that economy and assess the risk and move forward. We only have about 5% of our revenue exposed right now, but we think the potential there is substantial over time. It's an economic recession right now, but it will get out of that over some period of time.

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Philip Song: Got it. Thank you so much. I'll hop back in the queue.

Operator: Your next question comes from Lucas Baranowski from UBS. Your line is now open.

Lucas Baranowski: Hi, this is Lucas on for Dan Leonard at UBS. I guess to start things off, there's definitely been an increase in oil prices since the start of the year. Given that increase in costs, are you finding that you are able to pass that on to customers? And should we expect any kind of a margin impact there over the near term? Thanks.

Mark Sawicki: On extraordinary situations, we do have surcharges that we pass on – where we pass on extra cost. So I don't think you should expect margin impact from the petroleum increase.

Lucas Baranowski: Okay, thanks. And then just one more here. I guess, going back to the China theme, you touched on it a bit the initiative you have to begin manufacturing locally a little more over there. Are there any updates you can provide on how that's progressing and when that new capacity could come online?

Mark Sawicki: Well, of course, it's a small initiative, given the entirety of our company, and we're not in any hurry to make that investment right at this particular time, although that motion is still active. So you would see – probably mid next year, you would probably see made in China product coming out of the Chinese factory in addition to doors, it would be freezers as well.

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Lucas Baranowski: Okay, thanks. That's all I had.

Mark Sawicki: Thank you.

Operator: Your next question comes from David Larsen from BTIG. Your line is now open.

David Larsen: Hi. Can you talk a little bit more about these cost reduction efforts? And I know that you have been very reluctant to reduce labor across your firm, that's certainly very admirable. But just any more color there would be helpful. Do you expect to become EBITDA positive by, say, 4Q of 2024 or any sense for the number of positions that might be reduced or anything like that would be very helpful. Thank you.

Jerrell Shelton: I just want to make a couple of broad comments and then turn to Robert for more specific comments David. First of all, we are not reluctant to adjust our business in any way given circumstances after we have assessed them, we take great pride in being responsible in the way we manage our business and the assets that belong to the shareholders of this company. So, it's our fiduciary responsibility to be responsible – and that's what – and we take that very seriously. So we are not – when things business ebbs and flows and when it's appropriate, we adjust. We adjust just as I said in my opening comments with those initiatives that I mentioned there. Now, to give you a little bit more color on your specifics, I'll turn it to Robert.

Robert Stefanovich: Yes, look, in general, we certainly are working towards getting back to positive EBITDA and that, you are absolutely right, this is driven by some of the initiatives that we're taking related to cost reduction, related to picking up on the top line revenue. So these are things that we always do. But give you maybe a few data points, just you look at Q1, and we had about eight, little over $8 million in cash burn of that, a little bit over $4 million was related to CapEx expenditures. So we are moving out some of the CapEx, as I mentioned earlier on the call, just related to initiatives that are not high priority. Certainly, we're still making the investments in some of the key initiatives, such as intent to cryo-processing platform and other key offerings that we've been working on and that have partially been introduced into the market space. As you would expect with any company, especially with company that has done a number of acquisitions, we are looking to leverage our current capabilities and current resources. So can we leverage shared services? Absolutely. Yes, we can do that. Can we fine tune the resources that we have and streamline it? Absolutely. And those are things that we have been working on over the last few months that we've had already started rolling out and that we expect to have an impact in Q2 towards moving us into positive EBITDA. We're certainly very focused on maintaining a strong balance sheet, maintaining strong cash balance, and that all feeds into that equation in terms of how we look at our operational capabilities and investments.

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David Larsen: Okay, that's helpful. And then can you maybe talk a little bit about the revenue that's being generated from BioStorage/BioServices and also IntegriCell? And any update on storing allogeneic therapies? I know obviously a third of your trials are allogeneic in nature, but in terms of storing, was that actual cell tissue? Has that started yet? Any revenue coming from that yet?

Jerrell Shelton: Mark and Robert both may have some additional comments here. They will have some additional comments, David, but IntegriCell is not a subject right now for revenue because it won't be coming online until the last half of the year. And that will be the beginning of a ramp up. And after that you will see – over time, you will see IntegriCell producing significant revenues for the company. It's a service that's needed, the partnerships are coming along well, the factories are coming along well, and we have great, great anticipation of IntegriCell. In terms of a couple of the other things on BioServices in particular, Mark can better comment on BioServices and how that's coming along.

Mark Sawicki: Yes, I am going to focus on your specific question around allogeneic therapy as it relates to the need for storage and fulfillment related capabilities. So, we have obviously, as part of the infrastructure build over the last year and a half, built out competencies for secondary labeling and packaging requirements, which are all a base need for allogeneic therapy distribution. Those are currently being used by both clinical and commercial clients, both in the U.S. as well as in Europe. So we've been very successful in transitioning that investment into direct support of the cell and gene space itself. Allo, obviously, there's really – the only real allo product on the market right now is Atara, which is a low volume indication right now. So there is not going to be a significant financial impact on that in the short term. But there is also a contribution into BioServices over time for autologous therapies where they're supported – where we’re supporting backup doses, as well as other support elements, which also has the competencies over time to support additional revenues.

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David Larsen: Okay.

Jerrell Shelton: Lastly, maybe just to add there, you were looking for a dollar amount. The BioServices revenue grew 9% year-over-year to $3.5 million in the first quarter.

David Larsen: Okay. And I think that there were two large facilities that are fairly new that came online recently, one in Texas, one in New Jersey. Are those profitable now?

Mark Sawicki: Look, we are still in the early stages of our BioServices initiatives and both of those were introduced. And so we are really working towards filling up and bringing up the revenue in BioStorage/BioServices. We're in the early stages. When Mark is talking about utilizing them for the commercial therapies, for example, our statistics all just now commencing, so we're obviously not fully utilized at this point in time.

Robert Stefanovich: Hey David, remember, once we open those facilities, and those facilities were opened in, I think, it was June a year ago. So it takes six to eighteen months for clients to come in. They have to do their audits, and they have to do their trial runs, and then they have to rearrange the traffic and you know what they're doing. So it's just now ramping up. It does – BioServices, we always anticipated an exponential development. So I think we are still down there right around that point of inflection, and I think you'll see it picking up over time.

Mark Sawicki: Yes, we actually, Rob I just want to comment. Over the last 12 months in those facilities, we've actually onboarded 27 clients.

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David Larsen: Okay. And then just one more quick one, I think on last quarter's call, you talked about nine new therapies for 2024 and 17 filings in 2024. Does that mean nine new commercial therapies that you're supporting coming online in 2024? Is that what that means? And how is that number as of today? Is it still 9 and 17?

Jerrell Shelton: We have had so far this year, three new therapies get approved, that's CASGEVY, the CRISPR Vertex product, Amtagvi from Iovance, and most recently Anktiva from ImmunityBio. In our reporting today, we're saying we can see five more new therapies approved this year. So that would give you eight. So it has one as I'll call it pushed out. It hasn't gone away. It's probably going to be a 2025. And right now we're seeing 16 more filings in 2024.

David Larsen: Okay, thanks very much. I'll hop back in the queue.

Operator: Your next question comes from Paul Knight from KeyBanc. Your line is now open.

Paul Knight: Hi, Mark, I have a question for you for starters, and that is the Phase 3 trial, customer count was up the most in those that press release, meaning up 5.6%. Is this a significant indication that biotech is getting some money and getting back into the trial business early stage?

Robert Stefanovich: Well, we are seeing a lot of new money starting to come back into the space. We still see a lot of volatility and churn, as we had mentioned, we had a net add of 42 trials in the quarter, with a net removal of 42 trials. We always – our whole focus is around playing the portfolio, which means the collective average, so that we'll have winners and losers as it relates to those. But as long as we're supporting the vast majority of trials in the space, then we're on the upside. And we remain confident in that. And with the funding position seeming to stabilize and improving in Q1, obviously we need to see if that's sustainable, that's a positive indicator.

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Paul Knight: And then I think the conference [indiscernible] was 8000 employees. I mean, that's obviously a record, and not employees, but attendees in, I think, it was the American Society of Gene & Cell Therapy. Right? Are you seeing an uptick in potential customer interest?

Robert Stefanovich: Yes, I mean, there's a lot of new startups, and so a significant percentage of those 42 new programs came from new clients, which is a very good sign.

Paul Knight: And then I mean, we talk about a $7.7 million EBITDA loss. What do you really want to run the business at Jerry? And a few years out is this a 30% EBITDA margin business or is it 25%?

Jerrell Shelton: Paul, our goals have not changed. Our goals are 55% to 60% gross margin and 30% adjusted EBITDA. Our goals are not changed, and we do examine them often. So that's the metrics that you should be looking for from us.

Paul Knight: Thank you.

Operator: Your next question comes from Yuan Zhi, from B. Riley. Your line is now open.

Yuan Zhi: Thank you for taking our questions. So, can you help us better understand the weakness in biologic services in 1Q, was it because of lower volume? And how about the visibility and confidence in 2Q and beyond? And I have follow-up.

Jerrell Shelton: Mark is going to answer your question, but this has to do with the report that you put out just recently, I assume.

Thomas Heinzen: No, he is talking about BioServices.

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Mark Sawicki: Sorry, can you repeat the question, guys? Because we’re confused. I think it was a little garbled over here. I thought you said biologics, Jerry. I did too.

Jerrell Shelton: No, I thought you said biologics, you thought BioServices. What is it? Repeat the question.

Yuan Zhi: Yes. So can you help us better understand the weakness in biologistic services? Was it because of lower volume? And how about the visibility and confidence in 2Q and beyond?

Jerrell Shelton: Good. Okay, Mark…

Mark Sawicki: Yes, I got it now. Yes. So biologistics revenue was softer than anticipated because we saw those 42 trial terminations, and many of those were established programs with active volume that was ongoing. Those were replaced by 42 new starts. But those 42 new starts take time to ramp. And so just because we onboard them in the quarter, usually it's one to two quarters later before we start seeing a contribution as it relates to financial contribution. So we'll see progressive improvement on that as those new programs come online.

Yuan Zhi: Got it. And then on MVE, it seems that it's dropping from the last quarter. And I am just curious, was it because canceling of order or was it because the customers are just not there yet?

Jerrell Shelton: It was demand softness, continued demand softness. And again, mostly out of China, it was not cancellations of orders.

Yuan Zhi: Got it. And one last one from us for the goals to reduce some capital costs or reducing some cost in second half, I am curious, will that impact the revenue part? Because if you are cutting workforce – in sales – sales, it could have a certain degree of impact. Thank you.

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Jerrell Shelton: No, if you look at the actions that we're looking at related to, as I mentioned, some of the CapEx that we're moving out, these are not initiatives that will have an impact on our near-term revenue. They're not the high priority initiatives that we're working on. And same with some of the headcount review. This is not something that we expect to have any impact on our revenue as well as on our client relationships. Again, this is seen more as reviewing the organization, taking a closer look, especially after the number of acquisitions that we've completed and then kind of refining and the organizational structure.

Yuan Zhi: Got it. Thanks for the actual helpful color.

Jerrell Shelton: Thank you.

Robert Stefanovich: Thank you.

Operator: Your next question comes from David Saxon from Needham. Your line is now open.

David Saxon: I appreciate it. Thanks and good afternoon. I've been in between calls, so I apologize – I apologize if I am repeating any questions, but Jerry, maybe I'll start with you. So on the fourth quarter earnings call back in mid-March, you did seem to confirm expectations for sequential growth from the fourth quarter into the first quarter. So, over the two weeks before quarter end, were there any orders that got pushed out into the second quarter or what were the factors that drove the shortfall of sequential growth.

Jerrell Shelton: We did speak with confidence in the fourth quarter. We didn't know exactly how the first quarter was going to turn out. But what – we didn't say we were having a strong first quarter. What we did say as we gave revenue guidance and we said we would progressively improve throughout the quarters. And then the guidance came out higher than we expected it to come out, but it did come out that way. And we did have a – we recognized the weakness in the marketplace at that time and that's why we said that we would have – we would see a progressive improvement over the year. And I did confirm our guidance today. So, that's what happened. There was nothing specifically that I can say other than the market was slow, and we knew it was slow at the time and it was a little bit slower than we anticipated. So we were disappointed in the first quarter. But Mark may have something to add to that as well.

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Mark Sawicki: Yes. Obviously, we don't give guidance, right, on a quarterly basis. We're really looking at the entirety of the year itself. And across the board, between ourselves and other players in the space, we do strongly anticipate a continuous progression the second half of the year. So you look at uptick in consumables for the life sciences, that's a very strong indicator as it relates to pickup. And that was picked up in Q1, which does indicate development of therapies that we'll need biologistics and BioStorage through the rest of the year. Sequencing itself is sometimes difficult to ascertain because you can't have rollover from one quarter to the next. And the question is things that come in towards the end of the quarter, even if they have a PO or something else that slips that you don't anticipate, it can have a fairly significant impact on that end of quarter revenue. So we did see some POs and things like that slip out of the first quarter into the second quarter.

David Saxon: Okay, maybe, Mark, I will follow-up with some of the comments you just made. And I appreciate the cadence might be kind of difficult to predict, but I thought you said you expect continuous improvement in the second half. So, should we think about the second quarter being kind of flattish sequentially? And then we see some sequential growth in the second half to get to the guidance range. And then I'll just ask my second question here. This might be for both Jerry and Robert, on Bluebird Express. I'd love to hear how that integration is going. And then by my estimate, at least, revenue contribution was around $3 million. Is that in the right ballpark? And is that a good base that we can see growth off of? Thank you.

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Jerrell Shelton: I'll let Robert talk.

Robert Stefanovich: Yes, maybe you talk about your first question yet. Just if you look at what we experienced in Q3, Q4 of last year, we saw actually a slight improvement in Q4. Hence our outlook was the way we described it at year end. With that drop off, as Tom mentioned, particularly in Asia-Pac in Q1, some of that was certainly unexpected. But what we did talk about is to see a progressive improvement throughout the year, and that progressive improvement really weighted towards the second half of the year. I can't give you specifics related to Q2, but I can give you those two data points as they're progressively improving and then weighted towards the second half of the year.

David Saxon: Okay. Yes, that's super helpful. And then just on Bluebird Express, if you could.

Robert Stefanovich: Yes, Bluebird Express is integrating very well with CRYOPDP. It's a small acquisition, but we have done business with Bluebird Express for a number of years at Cryoport Systems, and it's a known quantity as having a very positive impact. It knows the U.S. market and it's having an impact on the development of CRYOPDP. We're opening three new logistics centers in the U.S. to build out that network, and I think we'll have a good year at CRYOPDP.

David Saxon: Okay. And so it sounds like $3 million might be the right ballpark [indiscernible].

Robert Stefanovich: [Indiscernible] lower end, but I think for modeling purposes, that's fine.

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David Saxon: Okay, great. All right, thanks so much.

Robert Stefanovich: Thank you, David.

Operator: There are no further questions at this time. Speakers, please proceed with your closing remarks.

Jerrell Shelton: Okay, thank you. Thank you for your questions and our discussions. Our first quarter results echoed a challenging global environment. Through market improvements – through market improvements and our actions, we expect our results will progressively improve during the remainder of the year. And based on the recent momentum we've seen with cell and gene therapy approvals, we're encouraged and feel confident in our full year 2024 revenue guidance. Cryoport is well positioned to capitalize on the growth of the life sciences, and particularly the cell and gene therapy industry, as more therapies receive FDA approval and achieve commercialization, and our services and product initiatives take effect. Even with the current economic and geopolitical climate, the market is expected to expand substantially over the next few years, and Cryoport is built to support its rapid growth. In summary, while our start in 2024 was softer than we would have liked, we will remain focused on our strategic priorities, continuing to expand our physician and our top accounts, delivering innovation, and differentiated new services and products, and remaining diligent on cost controls and productivity improvements to support increases in margins as we move through 2024. Thank you for joining us today. We appreciate your continued support and interest in our company. We look forward to updating you on our progress again next quarter. We hope you have a good evening. Thank you. Operator?

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

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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