Good day everyone, and welcome to the Cryoport Incorporated Third Quarter 2020 Earnings Results Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Todd Fromer. Please go ahead, sir.

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 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, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause the 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 other reports, which we file with the Securities and Exchange Commission. I would now like to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Thank you, Todd, and 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; 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 2020 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've 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'll move to addressing your queries regarding our company's results. We reported revenue of $11.2 million for the third quarter of 2020, an increase of 17% when compared to the third quarter of 2019 and a sequential growth of 19% when compared to the last quarter. The revenue increase was due primarily to growth in biopharma and reproductive medicine markets. The third quarter also marked the first revenue generated from another Cryoport-supported recently approved commercial therapy Gilead's TECARTUS. While the revenue generated from the therapy was small in the third quarter, it will continue to ramp in the fourth quarter and throughout 2021 along with Bluebird's ZYNTEGLO, which is expected to launch its commercial activity during the fourth quarter. Our global clinical trial activity, a cornerstone of our biopharma strategy and an important reservoir for our future revenue growth through commercialization in the coming years, continues to increase and Cryoport now supports a total of 517 clinical trials as of September 30, 2020, compared to 425 as of September 30, 2019. As you will remember, 56 clinical trials were suspended during our first quarter due to the COVID-19 pandemic and we're pleased to report that they have all been restarted as of the end of the third quarter. The conclusion of this quarter and the beginning of the fourth quarter marked two major milestones in the growth of our business and our platform for delivering comprehensive solutions for the temperature control supply chain needs of our clients, with the acquisition of MVE Biological Solutions and CRYOPDP. These acquisitions strategically advance Cryoport's position as MVE is the global leader in the supply of cryogenic solutions and CRYOPDP is the third largest global provider of temperature control specialty logistics solutions for the pharmaceutical industry. These acquisitions strengthen Cryoport's position in all its markets, especially biopharma, where customers will benefit from our expanded supply chain capabilities and enjoy much greater flexibility. One of the key tenets of these acquisitions is that they provide Cryoport the ability to capture a bigger share of the overall spend derived from a growing commercial pipeline that we believe will drive continuous strong revenue growth over the next five to ten years. As new trials advance to later stages, our revenue grows. With the addition of MVE and CRYOPDP, we're in a unique position to more fully support these advancements in ways not available heretofore. As clinical trials reach commercial stage, we believe that our enhanced global platform makes us the clear choice to help biopharma companies bring their therapies to market as we are now better than ever before positioned to support commercial distribution of cell and gene therapies on a global scale and with more depth. A total of seven Cryoport-supported marketing authorization applications or biologic license applications have been filed in 2020, and we expect a further two to be filed in the fourth quarter. We also anticipate up to 21 MAA or BLA submissions for Cryoport-supported products in 2021. We've been preparing for this growth for a number of commercial opportunities and we are equipped with personnel, competencies, know-how, facilities, technology, and equipment to support the dozens of new approved commercial therapies forecast over the next several years and the years thereafter. Recently, Bristol Myers Squibb selected Cryoport to support the potential global launch of liso-cel, which was recently validated by the European Medicine Agency marking Cryoport's fifth long-term agreement supporting the global commercial launch of a cell and gene therapy, which includes KYMRIAH by Novartis, YESCARTA, and TECARTUS by Gilead, and ZYNTEGLO by Bluebird. I think it's useful to remember that we have a deep working relationship with each of these companies and we support each of their clinical pipelines. During this quarter, Novartis renewed its contract with us, supporting all their commercial and clinical programs in cell and gene therapy.

Thank you. First, we'll go to Brandon Couillard from Jefferies. Your line is open.

Hey, guys. This is Matt on for Brandon this afternoon. Thanks for taking the questions. Quick one to start for Robert. Traditionally, you guys have not given guidance. But given that we have MVE and PDP rolling into the base here, any initial goalposts you can provide for us as we look at 4Q? And then for Jerry, has your philosophy around guidance changed at all following the two most recent deals?

Yeah. Just a few comments on that. Obviously, we closed both deals on October 1, so we're in the midst of working out the purchase price allocations and other aspects. In terms of giving guidance, we're very careful with guidance. We're at the very early stages of the growth of our company. But in terms of Q4 and beyond, if you look at the historical performance of the two companies that we acquired, we noted in previous calls CRYOPDP did about $48 million in revenues, MVE did about $81 million in revenues. If you look at that historic performance, and you look at bringing them into the fold of the Cryoport family of companies, we will obviously move towards accelerating that growth characteristic of both of those companies. So we can't give guidance at this point in time. What we will do, however, is we will be filing pro forma financials for the consolidated company, which will give you further insight in terms of the historic performance and the pro forma financial statements. Again, having said that, obviously, our expectations for both companies is that they will grow quite substantially over the next few years. One other aspect that we have mentioned in terms of overall revenue growth and our kind of aspirational targets moving forward over the next four or five years is to generate revenues and to be at a $650 million to $750 million revenue on a consolidated basis. Now you can ask how do we get to that significant ramp in revenues on a consolidated basis. That's a combination of growth through Cryoport Systems, as you know Cryoport Systems covers over 500 clinical trials at this point, with a significant backlog and pipeline of commercial therapies that are hitting the market over the next years; leveraging the synergies that we already see and target through the CRYOPDP acquisition, and then further, the expected growth through MVE providing their cryogenic equipment and solutions to the markets based on a global basis. So we feel pretty confident about the growth expectations over the next few years. In terms of the acceleration curve that obviously depends a lot on how the therapies hit the market, what the ramp looks like and so forth. And we'll talk a little bit more about that as part of this call.

Thanks. That's helpful. And then two on the COVID-related side, you noted 26 separate clinical trials you're supporting across the various business lines under Cryoport's umbrella, including a leading vaccine candidate. Can you provide any color on what unit is supporting that across PDP, Cryogene, or Cryoport Systems? And then on the handful of tenders MVE has received from the government, anything you can do there to kind of help the size of those today or what those could potentially grow to over time as the vaccines roll out here? Thank you.

Yeah. We're not breaking down disclosing what divisions we're working on specifically, what product lines. But suffice to say, obviously, the overall product line portfolio consists of 26 different products at this point in time and we are active in obviously evaluating the utilization of MVE equipment as it relates to long-term storage opportunities around COVID. And so we are very active in that space as well.

Thanks. That's helpful.

All right. We'll go next to Andrew D'Silva from B. Riley Securities. Your line is open.

Good afternoon. Thanks for taking my question. And sorry, if you did answer any of these, I was hopping between calls. But I'm still also reading through your quarterly review so forgive me. I don't think you mentioned this though. Can you give just some insight into any blank geographic locations that might still be out there when you as management are sitting there looking at the map of potential logistics sites that you might want to add in various locations, as you're looking at your pipeline? Obviously, CRYOPDP helps out a lot, but I'm just curious where else we should be thinking about new locations coming in?

Andrew, we will add supply chain centers and logistics centers over time. With the current absorption of the 27 locations that we now have, the additional locations that came from CRYOPDP and MVE are under evaluation right now. We do look at heat maps on where the activity takes place and we'll put those centers in places where demand dictates. But it's too early for us to give you any kind of an indication as to where they will be exactly.

And the only other thing I'd add to that is, one of the considerations we take as we do this evaluation is obviously what that commercial volume and portfolio looks like from a geographic standpoint, and our clients' willingness to subsidize facilities, obviously to provide a higher service level. And so those are other considerations that we look at as we evaluate locations.

Okay. No, that makes sense. And while we start just thinking about the acquisitions, and just the consolidated company, the three segments – or I guess four segments of Cryogene can you give us insight into how we should think about growth allocation per subsidiary? As a consolidated company, you referenced kind of a long-term 30% revenue growth CAGR. Do you see the legacy Cryoport Logistics being the fastest segment? Or do you think being consolidated within the parent will expedite CRYOPDP and MVE past Cryoport's legacy Logistics? Just kind of curious how we should start to think about the different segments in various situations?

Well Andrew, you've made some assumptions about segmentation that we haven't concluded yet. And so we will continue to look at the company as we have looked at it in the past. Because it's actually the way we make decisions and that is dividing our time and our thought process between biopharma, reproductive medicine, and animal health. These are four subsidiary companies. We do operate as an operating holding company. But our focus is on those markets as we cut across the markets and having cross agreements and synergies between those operating entities. So I would continue to look at reproductive medicine and animal health and especially biopharma and within that regenerative medicine.

Okay. Perfect. And just a last question for me. Novartis expanded its manufacturing footprint having the first approved site for CAR-T cell therapy in Asia. And I was just curious if the PDP facility facilities around there were adequately located or if there is anything else we should be thinking about as there's commercialization opportunities that are taking place in Asia?

Yes. We're looking hard at that and working very closely with Novartis and the other parties that are looking at APAC and particular expansion activity. So we will be launching our first two jointly operated facilities in Singapore and in Osaka in the fourth quarter of this year. That gives us a good base to obviously support the existing portfolio business. And we're also evaluating additional expansion opportunities for some of the other launch targets that these folks have in the coming quarters. So we are very active in that space right now.

Okay. Perfect. Thank you very much. Congrats on the progress and good luck integrating those acquisitions and closing out the year.

Thank you, Andrew.

Thanks.

And next, we'll go to Joseph Conway from Needham & Company. Your line is open.

Hi, guys. Just one question today concerning the strength in reproductive this quarter. How much of that are you guys attributing to catch-up from the second quarter versus the expansion of your facilities? Thanks.

So obviously, there is some catch-up associated with depression from Q2 COVID-related activities. However, we've also had a very well-defined strategy that we've been operating under over the last six quarters, which is really focused around capturing these large clinic networks like the Inception announcement we made earlier this year. We have signed additional agreements in that space now and all of those are starting to have a material impact on revenue contribution and we anticipate that contribution to continue to drive that number in a very positive direction.

And I would just add to that, Steve, that we're taking a more global approach to reproductive medicine because we have not penetrated Europe and Asia and other parts of the world to the degree that is available. And so we're certainly pushing in that direction. And globally, the number of cycles is up. It truly is a growth market. So it's a good market for us.

Okay. That's great to hear. I actually do have one more. If at all possible, could you detail the two BLA or MAA candidates that you expect to file in the fourth quarter?

We can. And Tom has that. Why don't you go through that, Tom?

Sure. Happy to. It is Atara their Tab-cel product and Gamida Cell with their Omidubicel. I could be pronouncing that poorly.

Great. Thank you.

And at this time, I'd like to turn it back to Jerry Shelton for closing remarks.

Thank you very much, operator. Folks, the takeaway I would like for you to have from this call is that through the execution of our two acquisitions, we achieved the conclusion of the third quarter and the beginning of the fourth quarter. At that time, we've built a new and extended platform for growth. We have increased our footprint in the industry and we are in an enhanced position to continuously scale our business as the leading temperature-controlled supply chain solutions company supporting the life sciences industry globally, and that is especially true for regenerative medicine. We're in an extraordinary position that will allow us to better serve the life sciences industry and grow our client relationships, existing and new. Innovation and leadership continue to be the hallmark of Cryoport. We believe that our company's drive for ever-increasing strong market position will be the force that drives our success and provides strong and perpetual revenue performance. Our future has never been brighter. We thank you for joining us today, and until our next earnings call, we bid you a good evening.

And this does conclude our call for today. Thank you for your participation. You may now disconnect.