Full Press Release Details
Cryoport Reports 2020 Third-Quarter
NASHVILLE, Tennessee (November 5, 2020)
- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport", "our" or "we"), a global leader in temperature-controlled
supply chain solutions for the life sciences industry, announced financial results for the Third Quarter and nine-month period
ended September 30, 2020.
"Our Third Quarter results reflect
solid performance and positive trends for Cryoport, powered by continued strength in Biopharma, with regenerative medicine clinical
trials supported by Cryoport increasing to 517, and Reproductive Medicine, which benefited from increased activity as fertility
clinics resumed operations as well as the expansion of our services to additional fertility clinic networks. I am proud of our
team's relentless passion and commitment to patients and clients around the world as we boldly fight the COVID-19 pandemic
and continue to serve our clients by delivering lifesaving therapies without interruption. Our team's resilient mindset,
combined with our strategic capabilities and execution excellence, increases our optimism for a continued ramp in 2020 and strong
momentum entering into 2021," said Jerrell Shelton, Chairman and CEO.
OVERALL FINANCIAL RESULTS:
| ($ in millions) | 2020 | 2019 | % Change | |||||||||
| Revenue | $ | 11.2 | $ | 9.6 | 17 | % | ||||||
| Gross Margin ($) | $ | 6.1 | $ | 4.6 | 31 | % | ||||||
| Gross Margin (%) | 54.2 | % | 48.3 | % | 12 | % |
"This was a seminal quarter for the
advancement of Cryoport's vision, mission and strategy. We successfully signed definitive agreements for our milestone acquisitions
of MVE Biological Solutions and CRYOPDP during the Third Quarter and closed both on October 1, 2020. With these important acquisitions,
we instantly expanded to 30 locations across the globe, as well as broadened our capabilities into the full range of temperature-controlled
supply chain solutions, covering controlled room temperature (CRT) down to cryogenic temperatures (-196 C). We also broadened
our capabilities by adding deep proficiencies in storage and transport devices that extend our abilities to provide more complete
solutions without dependence on outside resources. As a result, we are now in a strengthened competitive position in all our markets,
Animal Health, Reproductive Medicine and especially the Biopharma market, which is propelled by Regenerative Medicine. Most important,
we are positioned better than ever to support the anticipated dozens of commercial therapies around the globe, which we believe
will be the driving force behind our revenue growth over the next five years.
"To partially fund the purchase of
MVE, we partnered with Blackstone, a world leading global investment business with special interests in the life sciences industry.
Cryoport now operates as an operating holding company, with a family of companies that provide complementary and world-beating
temperature-controlled supply chain solutions for the life sciences industry and focused on the Biopharma, Reproductive Medicine
and Animal Health markets. This is especially important in our continuing development of capabilities for supporting the regenerative
medicine ecosystem, which has a growing number of therapies entering development and many approaching global commercialization.
As the undisputed market leader for temperature-controlled supply chain solutions for the life sciences industry, we have created
a new, enhanced platform for continued long-term growth. We are proud to have the size, global scale and opportunity to continue
to expand our support of the rapidly growing Regenerative Medicine ecosystem as the market continues to demonstrate rapid development
and our pipeline of potential commercial customers is the largest in our history.
"With our newly developed platform
for serving the life sciences industry with advanced temperature-controlled supply chain solutions and a rapidly growing market
to which we are committed, our future has never been brighter," concluded Mr. Shelton.
In the Third Quarter, Novartis renewed
its agreement with Cryoport for temperature-controlled supply chain support of KYMRIAH ; this follows Gilead's
Kite renewal of its agreement with Cryoport in support of its commercial and clinical therapies in the prior quarter. Cryoport
temperature-controlled supply chain solutions are integral to these companies' ability to provide their respective life-saving
therapies to patients.
The Third Quarter also marked the first
revenue generated from the recently approved commercial therapy TECARTUS from Gilead. While the revenue generated from TECARTUS
was small in the Third Quarter, we expect it and bluebird bio's ZYNTEGLO to ramp in the fourth quarter and
Subsequent to quarter end, Bristol Myers
Squibb selected Cryoport to support the potential global launch of Lisocabtagene Maraleucel (Liso-Cel), which was recently validated
by the European Medicines Agency (EMA), marking Cryoport's fifth long-term agreement supporting the global commercial launch
of a cell and gene therapy.
We continue to grow our leading position
in the Biopharma market and are pleased to also report continued strong clinical trial growth for the Third Quarter. As a note,
of the 56 clinical trials suspended at the end of the First Quarter due to the COVID-19 pandemic, none remain suspended as of the
end of the Third Quarter. Moreover, clinical trial activity has largely rebounded to pre-COVID levels and continues to accelerate
due to successful execution by Cryoport.
Global clinical trial activity continues
to increase and Cryoport now supports a net total of 517 clinical trials as of September 30, 2020 compared to 425 as of September
30, 2019. The number of those trials in Phase III is 66, compared to 54 as of September 30, 2019. Of the 517 total trials Cryoport
supports, 411 are in the Americas, 83 in EMEA (Europe, the Middle East and Africa) and 23 in APAC (Asia Pacific). This compares
to 360 in the Americas, 55 in EMEA and 10 in APAC as of September 30, 2019. Additionally, due to the increase in demand for support
in the APAC region, Cryoport Systems and CRYOPDP anticipate establishing their first two jointly operated logistics centers in
Singapore and Osaka, Japan in the Fourth Quarter of 2020.
A total of seven (7) Cryoport supported
Marketing Authorization Applications (MAA's) or Biologic License Applications (BLA's) have been filed in 2020, and
a further two (2) are expected to be filed in the Fourth Quarter, based on internal information and forecasts from the Alliance
for Regenerative Medicine (ARM). We also anticipate up to 21 MAA or BLA submissions for Cryoport-supported products in 2021.
Reproductive Medicine
Global adjustments to COVID-19 restrictions
allowed most fertility clinics to reopen, which led to a significant ramp in Reproductive Medicine revenue in the Third Quarter
which equated to a 62% increase compared to the same period in the prior year, led by our partnership with Inception Fertility.
Additionally, we signed partnerships with Cord Blood Registry and Generate Life in the Third Quarter, which are expected to continue
to spur our growth as we continue to expand in this important global market.
Animal Health revenue remained steady for
the three months ended September 30, 2020. Our pipeline of potential new clients continues to grow and is expected to generate
additional revenue in the Fourth Quarter and in 2021.
Mr. Shelton commented, "As the development
and distribution landscape for potential COVID-19 vaccines and treatments is still developing, we do not yet know the roles we
may play. However, in the fight against the COVID-19 pandemic, we are highly confident that we will be a part of the global solution
as we are now supporting 26 separate clinical trials, including a leading vaccine candidate, across our business units:
Additionally, recently MVE received several
orders from government tenders and through our distribution network for storage systems that are destined for use in storing pandemic
"We are committed to 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 chain network, and are proud to be supporting these important
and timely clinical stage vaccines and therapies."
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 September 30, 2020, which will be filed with the Securities and Exchange Commission ("SEC") on or about
November 6, 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 Third Quarter 2020 in Review", providing a review of Cryoport's recent financial and operational
performance and a general business update, will be issued at 4:05 pm ET on Thursday, November 5, 2020. The document is designed
to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations.
Cryoport management will host a conference
call at 5:00 pm ET on November 5, 2020. The conference call will be in the format of a questions and answers session and will address
any queries investors have regarding the Company's reported results.