Full Press Release Details
Cryoport Reports 2020 Second-Quarter
Revenue from commercial therapies increased
38% over the prior year
26 net clinical trial adds, now supporting
491 clinical trials in Regenerative Medicine market
NASHVILLE, Tennessee (August 6, 2020)
- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport"), a global leader in life sciences supply chain solutions, today announced
financial results for Second Quarter and six-month period ended June 30, 2020.
"For the Second Quarter of 2020,
we reported revenue of $9.4 million, an increase of 11% from the Second Quarter of 2019. This was largely driven by revenue from
our biopharma segment. We are pleased to have achieved these solid results and to have provided advanced temperature-controlled
supply chain services to deliver high-value therapies to eligible patients across our clinical and commercial portfolios globally
and without disruption," said Jerrell Shelton, Chairman and Chief Executive Officer.
"Our Second Quarter results reflect
the strength and resilience of our company where we saw continued year-over-year growth despite the challenging environment caused
by the COVID-19 pandemic. Thanks to the tireless work of our colleagues around the world, we continue to successfully navigate
the external realities, and we remain focused on our mission of supporting life and health by delivering reliable and comprehensive
temperature-controlled supply chain solutions for the life sciences through our innovation, advanced technologies, and global supply
"We now support four (4) commercial
cell and gene therapies: KYMRIAH , YESCARTA , TECARTUS
and ZYNTEGLO along with Lisocabtagene Maraleucel (liso-cel), which was recently validated by the European
Medicines Agency ("EMA").
"Gilead's Kite renewed our
agreement for temperature-controlled supply chain support of their commercial and clinical therapies, and we are in the final stages
of renewing our agreement with Novartis in support of its commercial and clinical therapies. Over the past several years, Cryoport's
advanced solutions have supported both KYMRIAH and YESCARTA through their respective clinical phases
and subsequent respective commercial rollouts. The continuance of these partnerships with these pioneers in the regenerative medicine
market is important as each extends its life-saving therapies to greater and greater patient populations, globally. We think that
as the only company with a proven and advanced integrated suite of proprietary temperature-controlled supply chain solutions to
support the global high-volume distribution of these valuable therapies, Cryoport's position is highly entrenched and we
work hard every day to maintain that position. These renewals together with the increasing number of clinical trials we support
demonstrate our leading position, which we will continue to fortify as the number of cell and gene therapy trials grow and commercial
therapies come to market.
"Also, during the second quarter,
FedEx extended its agreement with Cryoport Systems, a relationship that allows both companies to continue to jointly deliver temperature-controlled
solutions for select clients in the Biopharma, Animal Health and Reproductive Medicine markets. The continuation of this partnership
is a validation of Cryoport's innovative technologies and FedEx's foresight and an indication of the life sciences
industry's growing demand for advanced temperature-controlled supply chain solutions.
"We continue to grow our leading
position in the biopharma market and are happy to report strong biopharma clinical trial growth for the second quarter as a net
total of 26 clinical trials were added, bringing the total number of clinical trials supported by Cryoport to a record 491. And,
on another positive note, of the 56 clinical trials suspended at the end of the first quarter due to the COVID-19 pandemic, only
3 remain suspended as of the end of the second quarter. None of the remaining trials, to Cryoport's knowledge, have been
"Cryoport's market share leadership
of temperature-controlled life science solutions continues to grow stronger as our client base expands and our competency in tailored
information technology extends our market lead. The Alliance for Regenerative Medicine (ARM) reported that at the end of June there
were 11 ongoing clinical trials worldwide for the development of COVID-19 treatments utilizing regenerative medicine and advanced
therapies, and Cryoport supports eight of them. This area remains very active globally as many companies with the help of regulatory
support are moving at a rapid pace in search for a cure. Cryoport is committed to supporting these important programs as we all
seek an end to the global pandemic.
"In July 2020, another Cryoport-supported
therapy received FDA approval, bringing the total number of commercial products supported by Cryoport to four, and, in addition,
one more was validated by the EMA, and entered the EMA's centralized review process. A further six (6) Cryoport supported
Marketing Authorization Applications or Biologic License Applications are expected to be filed in 2020 and two additional commercial
approvals are possible, based on internal information and forecasts from ARM, although the timing of some of these may be impacted
by the COVID-19 pandemic and other factors."
Mr. Shelton continued, "We expect
revenue from our agreement with Gilead's Kite to increase following the recent FDA approval of TECARTUS ,
its chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell
lymphoma (MCL). We are also seeing an acceleration of other Cryoport supported regenerative therapies approaching commercialization
with the recent validation of Bristol Myers Squibb's Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)
"Cryoport now supports a net total
of 491 clinical trials as of June 30, 2020 compared to 413 as of June 30, 2019. The number of trials in Phase III grew to 66, compared
to 52 as of June 30, 2019. Of the 491 total trials Cryoport supports, 400 are in the Americas, 72 in EMEA (Europe, the Middle East
and Africa) and 19 in APAC (Asia Pacific). This compares to 353 in the Americas, 53 in EMEA and 7 in APAC as of June 30, 2019.
Our market leading share of clinical trials continues to climb as according to ARM there were a total of 1,078 active clinical
trials globally at the end of the second quarter, with 394 in Phase I, 587 in Phase II and 97 in Phase III.
"Another sign of the strength and
belief in the potential of cell and gene therapies can be seen in the financial markets. Despite the economic challenges and uncertainty
presented by the pandemic regenerative medicine companies raised approximately $10.7B in financing in the first half of 2020, a
120% increase from the first half of 2019.
"To meet upcoming customer demand,
further strengthen our global footprint and support capabilities, we are continuing to build out our new Cryoport Express
Global Supply Chain Network and our full range of temperature-controlled supply chain solutions, which include a full range of
bioservices and life sciences logistics support. Both new Supply Chain Centers in Morris Plains, NJ and Houston, TX should be online
by the first quarter of 2021. Additionally, we continue to build our global alliance network as we recently announced a partnership
with Medipal Holdings, one of the leading pharma wholesalers and distributors in Japan. This partnership helps us grow our abilities
"Cryogene, the life sciences industry's most trusted
biostorage facility specializing in the secure storage of biological specimens, materials, and samples for research purposes, contributed
revenue of $1.3 million for the second quarter. Its operations were minimally impacted by the COVID-19 pandemic and we continue
to plan the geographic expansion of our bioservices offering both in the U.S. and globally."
Mr. Shelton continued, "Animal Health
revenue remained steady at $0.2 million for the three months ended June 30, 2020; however, we are building a strong pipeline of
potential new clients and expect to grow Animal Health revenue in the second half of 2020."
Reproductive Medicine
"The Reproductive Medicine market
was impacted by the temporary closure of fertility clinics globally and, consequently, contributed revenue of $0.6 million in the
second quarter of 2020; however, we have begun to see restrictions lifted, leading to a significant ramp in Reproductive Medicine
revenue during the final month of the second quarter. We were pleased to see our partnership with Inception Fertility contribute
to this revenue ramp and believe we are well-positioned, globally, for growth in this important market."
Financial Highlights
Further information on Cryoport's
financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional
explanations of Cryoport's financial performance are provided in Cryoport's quarterly report on Form 10-Q for the three
months ended June 30, 2020, which will be filed with the Securities and Exchange Commission ("SEC") on or about August
10, 2020. The full report will be available on the SEC Filings section of the Investor Relations section of Cryoport's website
at www.cryoport.com.
Earnings Conference Call Information
IMPORTANT INFORMATION: A document
titled "Cryoport Second Quarter 2020 in Review", providing a review of Cryoport's recent financial and operational