CryoPort, Inc.

thank you for standing by this is the conference welcome to the cryoport first quarter 2021 earnings call as a reminder all participants are in listen only mode and the conference is being recorded after the presentation there will be an opportunity to ask questions to join the question queue you may press star then one on your telephone keypad Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to Todd Frommer, Managing Partner of KCSA, for opening remarks. 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. Gerald 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, Robert Stavanovich, our Chief Scientific Officer, Dr. Mark Sawicki, and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen. As a reminder, we have uploaded our first quarter 2021 and review document to our website. It can be found under the investor relations section in the events and presentation 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. Now for a brief general update followed by your questions regarding our first quarter results. Following our major accomplishments in 2020, we entered 2021 with an unrivaled leadership position with market-leading temperature control supply chain solutions for our biopharma, pharma, animal health, and reproductive markets. Our global platform now consists of 32 locations and a family of companies that provide mutually reinforcing solutions, services, and products. As anticipated, our new platform delivered outstanding performance for the first quarter, with revenue growing to a record $53.3 million. Our recent strategic acquisitions of MVE Biological Solutions and Cryo PDP contributed significantly to this performance as we navigated ongoing integration of these two excellent teams. Since closing the MVE Biological Solutions and Cryo PDP acquisitions, we have sharpened each team's focus on the cell and gene therapy market and made investments to fuel their growth, positioning us for excellent growth in 2021 and beyond. As a part of very large companies, neither Cryo PDP nor MVE Biological Solutions were focused on the high growth regenerative medicine markets. Now, as a part of Cryoport, we can leverage our deep expertise and resources to accelerate growth and market capture. In the short time since closing these acquisitions, we have made significant strides in defining strategic focus, aligning resources, identifying synergies, and stoking the respective innovation pipelines of each of these businesses. One example is the recent joint launch of Carport Systems and Crowd PDP's new Global Logistics Center in Osaka, Japan, which will further support and accelerate growth in the Asia-Pac region. As I previously expressed, We anticipate achieving over $100 million of revenue and cost synergies over a five-year period of time between crowd PDP and crowd port systems, and that is well underway. Excuse me. At MBE Biological Solutions, our production facilities are running at full capacity, breaking records monthly, as it benefits from a newly invigorated strategic direction. Revenue growth rates for both MBE Biological Solutions and Cryo PDP were significantly higher than their historical growth rates, and we believe these first two quarters as a part of CryoPORT are an early indicator of the growth potential of both of these operating units. We anticipate continued strengthening from both Cryo PDP and MBE throughout 2021. CryoPORT's overall organic revenue also increased by 35% year-over-year. Through our dedicated teams, ongoing investments, and expanded footprint, we now have a very broad reach within the industry and are dedicated to continuously scaling our business with focus and purpose. I'd like to emphasize that our business units reported record revenue year-over-year growth on a pro forma basis, as well as sequential growth over our record for fourth quarter 2020. The biopharma pharma market was the primary driver for our growth and represented approximately 80% of our total revenue for the first quarter 2021. And we continue to build out our pipeline of potential commercial customers with total number of regenerative medicine clinical trials supported by crowdport reaching a record 543 trials compared with 465 at the end of the first quarter 2020. Commercial revenue was generated primarily from our global agreements, supporting the continued market introduction of Novartis' Camrya and Gilead's Yascarta. In addition, Bristol-Myers Web has received FDA approval for its cell therapy, Brezania, and Bluebird Bio and BMS have received FDA approval for their CAR T-cell therapy, Abacma, the first of its kind CAR-T cell therapy for the treatment of multiple myeloma. These therapies mark Crowdport's sixth and seventh long-term agreements supporting the global commercial launch of a cell and gene therapy. We expect these agreements to begin to contribute to our revenue in the second quarter of 2021 and ramp throughout the remainder of the year, driving additional growth in our commercial revenue in 2021. A total of three Cryoport-supported MAAs or BLAs were filed in the first quarter of 2021. Based on internal information and forecasts from the Alliance for Regenerative Medicine and looking forward, we anticipate up to 18 MAA or BLA submissions for Cryoport-supported products during 2021. In addition to our organic growth rate, I'm sorry, in addition to our organic growth and due to increasing demand for support in the APAC region, we supplemented our Osaka opening by acquiring Critical Transport Solutions Australia, a market leader focused on premium healthcare logistics management services, specializing in in-time excuse me, specializing in time and sensitive critical solutions for the biopharma, pharma, and medical industries in Australia. As a part of CrowdPort's CrowdPDP business unit, CTSA will also support CrowdPort systems in Australia. CTSA is expected to have strategic impact on our APAC initiatives as the number of clinical trials in the region continues to increase. The acquisition of CTSA is an important step in our APAC strategy, as with the addition of CTSA, we will be able to serve the domestic Australian market more effectively, as well as providing robust temperature control supply chain solutions for the international clients who need support throughout the APAC region. Now I'd like to request that the operator open the lines for questions.