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Cryoport Reports Results for the Third Quarter 2022 Third quarter revenue of $60.5 million; nine months 2022 revenue reaches $176.9 million; Cryoport Systems' revenue up 25% year-over-year $530 million in cash and short-

Key Takeaway: Cryoport Reports Results for the Third Quarter NASHVILLE, Tennessee, November 3, 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 resu

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Cryoport Reports Results for the Third Quarter
NASHVILLE, Tennessee, November 3,
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- and nine-month periods ended September
Jerrell Shelton, CEO of Cryoport, commented, "Like
many companies that operate globally, we were subject to macroeconomic headwinds during the third quarter and expect some of these pressures
will extend into the fourth quarter. Specifically, during the third quarter, we experienced a convergence of macroeconomic pressures that
impacted revenue including: a negative foreign exchange impact of $2.6 million due to the increased strength of the U.S. dollar against
certain foreign currencies; recurring COVID lockdowns in China; supply chain related issues; the Russia/Ukraine war and its ripple effect
throughout Europe; and industry capacity limitations, which interfered with cell and gene therapy commercial revenue acceleration.
"During the third quarter, we also saw a
shift in cryogenic freezer sales through distributors to smaller, lower cost units as customers became more reserved in regard to capital
purchases. Like any company that sells a broad range of products, we expect to experience some level of order variability during any given
quarter. However, the shift in the third quarter was sharp and is likely tied to concerns about the general economic environment. As of
now, we see this purchasing trend continuing in the fourth quarter, but we remain confident that the life sciences market fundamentals
are sound and will continue to drive long-term demand for our comprehensive set of products and services.
"We have not seen erosion in demand from
our key cell and gene therapy customers as Cryoport Systems grew over 25% year-over-year and as we continued to increase the number of
clinical programs that Cryoport supports, adding another 17 clinical trials during the quarter, bringing our total to a record 643 global
clinical trials. However, the impact from the previously mentioned macroeconomic factors affected other parts of our business and prompts
us to reevaluate our annual guidance for 2022. Based on these factors, we are now anticipating full year 2022 revenue to be in the range
of $232 million to $238 million.
"Despite these headwinds impacting our second
half 2022 performance, we remain positive given the persistent demand from our target markets. We are optimistic about further advancing
our leadership position in providing temperature-controlled supply chain solutions to the life sciences industry and expect to resume
our overall growth as macroeconomic conditions subside and as our new products and services launch in 2023. We continue to position ourselves
for anticipated rapid growth in the cell and gene industry, through product and service developments including our newly commissioned
Cryoport Systems Global Supply Chain Center Network, the expected launches of the Cryoportal Logistics Management System
2.0, SkyTraxTM, a revolutionary condition monitoring system, the CryoSphereTM, a revolutionary Elite shipper
that reduces shipping risks for cell and gene therapies, new model launches of MVE Vario and MVE Fusion
freezers, and our Direct-to-Patient service over the next few quarters. These new products and services are expected to further expand
our market presence, create new future revenue streams, and enable us to support the growing number of commercial cell and gene therapy
products more broadly.
"Our efforts to proactively address our
macroeconomic challenges are far ranging. We are entering the market for apheresis collection to answer the industry need for better starting
materials in cell and gene therapies through our recently announced strategic relationship with Takeda's BioLife Plasma Services. This
partnership is expected to generate new revenues for Cryoport beginning in 2023 and stretching over years to come. We believe Cryoport
has never been stronger with significant industry changing business development initiatives underway. We feel that these strategic actions
will strengthen our business and position us to begin to take advantage of opportunities in 2023 and beyond. The commitment of our team
is resolute and its commitment to deliver solutions that support life-saving cell and gene therapies is second to none," concluded
In tabular form, revenue by market for the three-
and nine-month periods ended September 30, 2022, as compared to the same periods in 2021 was as follows:
Cryoport, Inc. and Subsidiaries Total revenues by market (unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
(in thousands) 2022 2021 % Change 2022 2021 % Change
Biopharma/Pharma $ 48,570 $ 46,001 6% $ 143,309 $ 133,878 7%
Animal Health 9,629 8,261 17% 25,985 25,655 1%
Reproductive Medicine 2,265 2,431 -7% 7,625 6,635 15%
Total revenues $ 60,464 $ 56,693 7% $ 176,919 $ 166,168 6%
As of September 30, 2022, the Company supported
nine (9) commercial therapies and a total of 643 global clinical trials, a net increase of 61 clinical trials over third quarter 2021
and a net increase of 41 clinical trials from year-end 2021. The number of trials in Phase 3 was 80 as of September 30, 2022. The number
of trials by phase and region are as follows:
Cryoport Supported Clinical Trials by Phase
September 30,
Clinical Trials 2020 2021 2022
Phase 1 207 240 268
Phase 2 244 272 295
Phase 3 66 70 80
Total 517 582 643
Cryoport Supported Clinical Trials by Region
September 30,
Clinical Trials 2020 2021 2022
Americas 411 459 496
EMEA 83 92 105
APAC 23 31 42
Total 517 582 643
During the third quarter of 2022, bluebird bio's
SKYSONA received FDA approval for Early, Active Cerebral Adrenoleukodystrophy (CALD), bluebird bio's ZYNTEGLO
received FDA approval for Beta-thalassemia, Gilead/Kite's Tecartus received approval from the European Commission
for the treatment of relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL), and subsequent to quarter end,
Gilead/Kite's Yescarta received approval as a second line treatment for Diffuse Large B-cell Lymphoma (DLBCL) from
the European Commission. A total of two (2) Cryoport supported Biologic License Applications (BLAs) were filed in the third quarter, bringing
the number of filings through September 30, 2022, to six (6). During the remainder of 2022, we anticipate up to an additional seven (7)
filings, and two (2) new therapy approvals. We are now forecasting a combined total of 26 BLA or MAA filings in 2023, up three (3) from
our previous estimate of 23 filings.
In addition, during the third quarter Cryoport
entered a strategic relationship with Takeda's BioLife Plasma Services, intended to provide consistent, high-quality cellular starting
material for use in the manufacture of cell therapies. By bringing together Takeda's BioLife Plasma Services' proficiency in apheresis
collection through their donation center infrastructure with Cryoport's expanding capabilities and expertise in the temperature-controlled
supply chain, the companies aim to establish a standardized, integrated apheresis collection, processing, and distribution solution dedicated
to cell and gene therapies. Importantly, the new platform will leverage the cryo-processing expertise of Cell Matters, which Cryoport
acquired in late July 2022. Operations are expected to begin in early 2023 with apheresis scheduling and collections to be initiated by
Takeda's BioLife Plasma Services in the Houston area supported by Cryoport cryo-processing capabilities being established near our
Texas Global Supply Chain Center. Cryoport will
provide supply chain solutions inclusive of packaging, logistics, data management, consulting, program management, cryo-processing, and
Financial Highlights
Total revenue for the third quarter
of 2022 was $60.5 million compared to $56.7 million for the third quarter of 2021, a year-over-year increase of 7% or $3.8 million, and
11% at constant currency, driven by the continued demand for Cryoport's comprehensive supply chain solutions and systems.
Total revenue for the nine months ended
September 30, 2022, increased to $176.9 million compared to $166.2 million for the same period in 2021, a year-over-year increase of 6%
or $10.8 million, and 10% at constant currency. Revenue for the nine months ended September 30, 2022 was adversely impacted by approximately
$9.4 million during the first quarter of 2022 from the fire at our New Prague, Minnesota manufacturing facility.
Gross margin was 43.7% for the third
quarter of 2022, an increase of 222 basis points from 41.5% in the third quarter of 2021. Gross margin was 43.9% for the nine months ended
September 30, 2022, compared to 44.2% for the same period in 2021. Gross margins were primarily impacted by increased costs due to global
supply chain constraints, as well as the ramp up of resources to support the expected increase in demand for our solutions and the opening
of two global supply chain centers.
Operating costs and expenses increased
by $6.1 million, or 22% to $34.2 million for the third quarter of 2022 compared to $28.1 million for the third quarter of 2021. The increase
was primarily attributable to the further build out of our competencies, global infrastructure, and technology development to support
the continuing scaling of our business, broadening of our solutions and expected demand for Cryoport's systems and solutions. Operating
costs and expenses increased for the nine months ended September 30, 2022 by $15.5 million, or 19% to $98.5 million compared to $82.9
million for the same period in the prior year.
Net loss for the three- and nine-month
periods ended September 30, 2022 was $5.3 million and $27.9 million, respectively, compared to a net loss of $6.5 million and $15.4 million
for the same periods in 2021, respectively. Net loss for the three- and nine-month periods ended September 30, 2022 was partially impacted
by a non-cash expense of $3.9 million and $12.5 million, respectively, related to unrealized losses on the mark-to-market value of certain
securities investments, which was partially offset by a gain of $4.8 million recognized during the third quarter of 2022, as a result
of business interruption and related insurance coverage related to the fire damage at our New Prague, Minnesota manufacturing facility.
Net loss attributable to common stockholders
was $7.3 million, or $0.15 per share and $33.9 million, or $0.69 per share, for the three- and nine-month periods ended September 30,
2022, respectively. This compares to a net loss attributable to common stockholders of $8.5 million, or $0.18 per share and $21.6 million,
or $0.48 per share, for the three- and nine-month periods ended September 30, 2021, respectively.
Adjusted EBITDA was $4.7 million for
the third quarter of 2022, compared to $6.0 million for the third quarter of 2021. Adjusted EBITDA for the nine months ended September
30, 2022 was $13.0 million compared to $19.1 million for the same period in 2021. The decrease for the nine-month period primarily reflects
Last updated: Nov 3, 2022