CryoPort, Inc.

Good day, everyone, and welcome to the CryoPort, Inc. third quarter 2020 earnings results call. Today's call is being recorded. At this time, I would like to turn the conference over to Mr. Todd Frommer. 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 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 your 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 in 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. 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 crowd port supported recently approved commercial therapy, Gilead's Cercardos. 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 Zenteclo. 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 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 the comprehensive solutions for the temperature control supply chain needs of our clients with the acquisition of MVE Biological Solutions and Cryo PDP. These acquisitions strategically advance CryoPort's position as MVE as the global leader in the supply of cryogenic solutions and Cryo PDP is the third largest global provider of temperature control specially logistic solutions for the pharmaceutical industry. These acquisitions strengthen CryoPort's position in all its markets and especially biopharma, where customers will benefit from our expanded supply chain capabilities and enjoy much greater flexibility. One of the key tenants 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 10 years. As new trials advance to later stages, our revenue grows. With the addition of MBE and cryo PDP, 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 Crawport supported products in 2021. We've been preparing for this growth for a number of commercial opportunities and we are equipped with personnel with competencies and know-how, facilities, technology and equipment to support the dozens of new approved commercial therapy forecasts over the next several years and the years thereafter. Recently, Bristol-Myers Squibb selected CryoPort to support the potential global launch of LysoCell, which was recently validated by the European Medicine Agency, marking CryoPort's fifth long-term agreement supporting the global commercial launch of a cell in gene therapy, which include Chimera by Novartis, Yascarta, and Takardas by Gilead's Kite and Zen Teglow 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. With that, I would like to turn this call over to the operator to open the telephone lines for your questions.