Full Press Release Details
Cryoport Reports Fourth Quarter and Full Year
Tennessee, February 24, 2022 - Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"),
a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced financial results for
the three months and year ended December 31, 2021.
Jerrell Shelton, CEO of Cryoport, commented,
"Last year was an important year for Cryoport. Our total revenue grew to a record $222.6 million driven by strong performance by
MVE Biological Solutions and CRYOPDP as well as significant organic revenue growth of 40% from Cryoport Systems and CRYOGENE. In our first
full year following the transformational acquisitions of MVE Biological Solutions and CRYOPDP, we firmly established Cryoport as a global
market leader for comprehensive supply chain solutions for the life sciences industry. And we sharpened our focus on the rapidly growing
Cell & Gene Therapy market with an expanding platform of products, services, systems, and solutions. Our overall pipeline of
business continues to strengthen with Cryoport Systems now supporting a record 602 clinical trials and 8 commercial therapies globally.
To meet our strong and accelerating demand, we have expanded our global network to 33 facilities in 15 countries, strengthened our presence
in the high growth APAC and EMEA regions, and completed preparations for the upcoming opening of our first two new Global Supply Chain
Centers in the United States. We closed 2021 in the strongest position in our company's history, with $629 million in cash and short-term
investments to support our organic growth as well as provide us with the ability to complete future acquisitions.
"Notwithstanding the global supply
chain challenges, fourth quarter revenue reached $56.4 million, an increase of 17% year-over-year. This performance was driven by strong
organic year-over-year revenue growth of 34% from Cryoport Systems and CRYOGENE, and a solid performance from CRYOPDP and MVE Biological
Solutions despite third-party shipping delays that caused approximately $2.0 million of MVE's revenue to shift to the first quarter
of 2022. Throughout 2021, our teams continued to execute and perform at a very high level across all business units.
"On January 25, 2022, a
fire occurred in a portion of MVE Biological Solutions' New Prague manufacturing facility. The fire caused a curtailment of activity
for approximately three weeks, but production has resumed and is now ramping. We expect the revenue impact to be between $4 million and
$5 million and to be limited to the first quarter of 2022. Currently, demand for MVE Biological Solutions' products and systems
is at an all-time high and plans are underway to further increase capacities in both United States manufacturing plants.
"Our Biopharma/Pharma revenue
increased 18% year-over-year in the fourth quarter of 2021, while Biopharma/Pharma revenue for Cryoport Systems and CRYOGENE grew 38%,
demonstrating continued strong traction in the Cell & Gene Therapy market. We now support a record 602 clinical trials, compared
with 582 at the end of the third quarter of 2021 and 528 at the end of the fourth quarter of 2020. We also support eight commercial therapies
in regenerative medicine, including Novartis' KYMRIAH , Gilead/Kite's YESCARTA and TECARTUS ,
bluebird bio's ZYNTEGLO and SKYSONA , Bristol Myers Squibb's BREYANZI and ABECMA
and Orchard Therapeutics' LIBMELDY .
"Our revenue by market for the
three months and year ended December 31, 2021, as compared to the same periods in 2020 was as follows:
Cryoport, Inc. and Subsidiaries
Total revenues by market
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||
| (in thousands) | 2021 | 2020 | % Change | 2021 | 2020 | % Change | ||||||||||||||||||
| Biopharma/Pharma | $ | 46,325 | $ | 39,301 | 18 | % | $ | 180,203 | $ | 66,394 | 171 | % | ||||||||||||
| Animal Health | 7,698 | 7,168 | 7 | % | 33,353 | 7,846 | 325 | % | ||||||||||||||||
| Reproductive Medicine | 2,417 | 1,892 | 28 | % | 9,052 | 4,456 | 103 | % | ||||||||||||||||
| Total revenues | $ | 56,440 | $ | 48,361 | 17 | % | $ | 222,608 | $ | 78,696 | 183 | % |
Mr. Shelton concluded, "The
rapidly growing Cell & Gene Therapy market we serve is still in its formative stages and demand for our systems and solutions
continues to accelerate. We now support many of the world's leading life sciences companies with mission-critical supply chain solutions
as they endeavor to bring their therapies through clinical trials to the commercial market and ultimately patient populations worldwide.
As the therapies we support advance through the clinical stages, we anticipate a growing number of commercial opportunities to emerge,
bolstering our long-term outlook for revenue growth and market share gains. We plan to further strengthen our leadership position with
a primary focus on service, innovation, and expansion in key markets throughout the world."
Total Biopharma/Pharma revenue represents
over 80% of Cryoport's total revenue and increased by $7.0 million, or 18%, to $46.3 million for the fourth quarter of 2021 compared
to $39.3 million for the fourth quarter of 2020, driven by strong revenue contributions from all business units. For the fourth quarter
of 2021, Biopharma/Pharma revenue for Cryoport Systems and CRYOGENE grew by $4.2 million, or 38%, to $15.2 million compared to fourth
quarter of 2020 demonstrating continued maturation of Cryoport's position within the regenerative medicine market.
As of December 31, 2021, the Company
supported a net total of 602 clinical trials, a net increase of 20 clinical trials during the fourth quarter of 2021 and 74 clinical trials
for the year. The number of trials by phase and region are as follows:
| Cryoport Supported Clinical Trials by Phase | ||||||||||||
| December 31, | ||||||||||||
| Clinical Trials | 2021 | 2020 | 2019 | |||||||||
| Phase 1 | 255 | 220 | 185 | |||||||||
| Phase 2 | 273 | 239 | 195 | |||||||||
| Phase 3 | 74 | 69 | 56 | |||||||||
| Total | 602 | 528 | 436 |
| Cryoport Supported Clinical Trials by Region | ||||||||||||
| December 31, | ||||||||||||
| Clinical Trials | 2021 | 2020 | 2019 | |||||||||
| Americas | 475 | 419 | 361 | |||||||||
| EMEA | 93 | 84 | 61 | |||||||||
| APAC | 34 | 25 | 14 | |||||||||
| Total | 602 | 528 | 436 |
A total of eleven (11) Cryoport supported
Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in 2021, based on internal information
and data from the Alliance for Regenerative Medicine, of which two (2) were filed during the fourth quarter of 2021. During 2022,
we anticipate up to an additional nineteen (19) filings, (4) new therapy approvals, and an additional six (6) label or geographic
expansion approvals.
Our commercial Cell & Gene
Therapy clients continued to expand during 2021, including:
Novartis filed in the United States,
Europe, and Japan to expand the use of KYMRIAH into follicular lymphoma. Currently KYMRIAH is approved
to treat third line diffuse large B-cell lymphoma (DLBCL) and acute lymphoblastic leukemia (ALL).
Gilead/Kite filed, and was granted
Priority Review by the FDA, for a supplemental biologic license application in the United States to move YESCARTA from
a third line to a second line treatment for DLBCL with an upcoming expected regulatory decision on April 1, 2022. Gilead also made
regulatory submissions with the European Medicines Agency ("EMA") and expects to receive notice in the second half of 2022.
YESCARTA is also currently approved for the treatment of follicular lymphoma.
Bristol Myers Squibb (BMS) also had
significant commercial news in 2021 as BREYANZI was approved in the United States for third line DLBCL and ABECMA
became the world's first CAR-T therapy to be approved for the treatment for multiple myeloma. Recently, BMS announced that ABECMA
has also been approved in Japan and that they expect data in 2022 to support the move of ABECMA from a fifth line treatment
to a second line treatment. On February 17th, 2022, BMS announced that their supplemental BLA has been accepted by the
FDA to move BREYANZI from a third line to a second lined treatment for DLBCL. BMS has also secured a priority review of
the supplemental BLA from the FDA and expects a regulatory decision by June 24th, 2022.
Financial Highlights
Note: All reconciliations of GAAP to
adjusted (non-GAAP) figures above are detailed in the reconciliation tables included later in the press release.
information on Cryoport's financial results is included in the attached condensed consolidated balance sheets and statements of
operations, and additional explanations of Cryoport's financial performance are provided in Cryoport's Annual Report on Form 10-K
for the year ended December 31, 2021, which is expected to be filed with the Securities and Exchange Commission ("SEC")
on or before March 1, 2022. 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
INFORMATION: A document titled "Cryoport Fourth Quarter and Full Year 2021 In Review", providing a review of Cryoport's
recent financial and operational performance and a general business update, will be issued at 4:05 p.m. EDT on Thursday, February 24,
2022. The document is designed to be read by investors before the questions and answers conference call and will be accessible at: http://ir.cryoport.com/events-and-presentations.
management will host a conference call at 5:00 p.m. EDT on February 24, 2022. 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. A slide
deck will accompany the call.
Conference Call Information
| Date: | February 24, 2022 |
| Time: | 5:00 p.m. EDT |
| Dial-in numbers: | 1-877-407-0789 (U.S.), 1-201-689-8562 (International) |
| Confirmation code: | Request the "Cryoport Call" |
| Live webcast: | Investor Relations' section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software. |
and answers will be recorded and available approximately three hours after completion of the live event on the Investor Relations section
of the Company's website at www.cryoport.com for a limited time. To access the replay of the questions and answers, please
follow this link. A dial-in replay of the call will also be available to those interested, until 11:59 p.m. ET on March 3,
2022. To access the replay, dial +1 844-512-2921 (United States) or +1 412-317-6671 (International) and enter replay pin number: 13726525.
About Cryoport, Inc.
(Nasdaq: CYRX), headquartered in Nashville, TN, is a global leader in temperature-controlled supply chain solutions for the life
sciences industry supporting life-saving cell and gene therapies across the clinical and commercial spectrum. With 33 strategic locations