Cryoport Reports First Quarter 2023 Results
- Record revenue of
$63 million 20% growth year-over-year - Growth across all lines of business: Biopharma/Pharma revenue up
19% ; Animal Health revenue up30% ; Reproductive Medicine revenue up13% year-over-year - Commercial Cell and Gene Therapy revenue up
28% year-over-year, now supporting 82 Phase 3 clinical trials - Strong balance sheet with
$523 million
Jerrell Shelton, CEO of Cryoport, commented, "We are pleased to report that we delivered record revenue of
"We saw solid growth in Biopharma/Pharma with revenue increasing
"Growth in Animal Health revenue for the quarter increased over
"Reproductive Medicine revenue was
"Looking ahead, given the current geopolitical instability and imbalance in the world economy, we remain committed to continuing our momentum throughout the remainder of 2023. We expect to benefit from growth in all our markets and especially the dynamic cell and gene therapy industry where Cryoport supports a total of 652 clinical trials globally with 82 of these in phase 3.
"As a leader in the development of advanced temperature-controlled supply chain solutions for the life sciences industry, we have recently launched the Cryoportal® v2 Logistics Management System. The Cryoportal® v2 is the first and, to our knowledge, the only ISPE GAMP® 5.0 validated system of its type to serve the life sciences and provides many new features and enhancements.
"Of course, we have not stopped there. Other key product and services initiatives planned for launch this year include our next generation, advanced Cryoport Elite™ shipper line, which is now starting to roll out with our ELITE™ Ultra-cold -80°C line of shippers supporting gene therapies. Cryoport ELITE™ shippers will provide additional de-risking, longer temperature hold-times, more advanced communications features, and new security controls. Near the end of the year, our SkyTrax™ Condition Monitoring System, a generational leap to an advanced condition monitoring system that will support temperature ranges from controlled room temperatures to cryogenic temperatures, will also be released as well.
"As we move forward, we expect the robust cell and gene therapy industry to continue its march forward and we will continue to provide new, innovative services and products that will drive our organic growth. Good examples of this are the build-out of our Global Supply Chain Center Network, the introduction of our IntegriCell™ platform to supply autologous and allogeneic cell therapies a standardized apheresis collection and end-to-end cryopreservation service for leukapheresis derived therapies, as well as our Fusion® and Vario® Cryogenic Freezer Systems.
"Our strategy and our team are committed to ensuring Cryoport is always delivering the highest quality, most reliable solutions to support life-saving cell and gene therapies, and we are constantly evaluating opportunities to ensure this – because we know 'a patient is waiting.'
"In my opinion, Cryoport is in a great position in the industry today and has never been stronger than it is today. We are looking forward to fulfilling our vision of becoming the essential supply chain company serving the life sciences," concluded Mr. Shelton.
Total revenues by market for the three months ended March 31, 2023, as compared to the same period in 2022 was as follows:
Cryoport, Inc. and Subsidiaries | ||||
Total revenues by market | ||||
(unaudited) | ||||
Three Months Ended March 31, | ||||
(in thousands) | 2023 | 2022 | % Change | Change |
Biopharma/Pharma | $ 51,122 | $ 43,011 | 18.9 % | $ 8,111 |
Animal Health | 8,863 | 6,794 | 30.4 % | 2,069 |
Reproductive Medicine | 2,832 | 2,497 | 13.4 % | 335 |
Total revenues | $ 62,817 | $ 52,302 | 20.1 % | $ 10,515 |
Biopharma/Pharma
As of March 31, 2023, Cryoport supported ten (10) commercial therapies and a total of 652 global clinical trials, a net increase of 43 clinical trials on a year-over-year basis. The number of trials in phase 3 was 82 as of March 31, 2023. A total of 37 trials were completed or terminated in the first quarter of 2023, while 35 new trials were started. The number of clinical trials supported by Cryoport by phase and region at the end of the quarter was as follows:
Cryoport Supported Clinical Trials by Phase | |||
Clinical Trials | March 31, | ||
2021 | 2022 | 2023 | |
Phase 1 | 222 | 251 | 269 |
Phase 2 | 252 | 277 | 301 |
Phase 3 | 69 | 81 | 82 |
Total | 543 | 609 | 652 |
Cryoport Supported Clinical Trials by Region | |||
Clinical Trials | March 31, | ||
2021 | 2022 | 2023 | |
429 | 477 | 502 | |
EMEA | 86 | 99 | 108 |
APAC | 28 | 33 | 42 |
Total | 543 | 609 | 652 |
Some of the significant cell and gene therapy developments during the first quarter of 2023 were as follows:
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Bristol Myers' Breyanzi® for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after first-line chemoimmunotherapy treatment. Following the quarter end, Breyanzi® was approved by the EMA as a second line treatment for adult patients with DLBCL, high grade B-cell lymphoma (HGBCL), PMBCL and follicular lymphoma grade 3B (FL3B). This approval covers all European Union member states.
- The
U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), andJapan's Ministry of Health, Labour, and Welfare accepted Bristol Myers Squibb's and 2seventy bio's supplemental Biologics License Application (sBLA) for Abecma® for earlier use in adults with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. - A total of four Cryoport supported Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in the first quarter of 2023.
- Subsequent to the first quarter of 2023 one customer filed a BLA with the FDA, one customer had a therapy approved by the FDA, and one customer's therapy was approved by the EMA to move to an earlier line of treatment.
During the remainder of 2023, we anticipate up to an additional 18 application filings, 10 new therapy approvals and an additional 11 label or geographic expansion approvals.
Additionally, in January 2023, Cryoport established a new strategic partnership with Syneos Health to support the global advancement of cell and gene therapies, providing the industry's first fully integrated biopharmaceutical and temperature-controlled supply chain solution. The new partnership couples the full suite of clinical development services offered by Syneos Health with IntegriCell™, Cryoport's new emerging platform providing standardized apheresis collection, cryoprocessing, cryopreservation services, temperature-controlled supply chain support, storage, secondary packaging, and labeling.
Animal Health
We believe the Animal Health industry is poised for significant growth in the coming years, driven by two key factors. First is the rise in the global population and increased demand for animal-derived protein. Second is the growing trend of companion animal ownership in developing and emerging countries, creating a larger opportunity for animal healthcare products and services. Combined, we anticipate that these factors will fuel the ongoing research and development of novel therapies and treatments, further advances in genomic tools and other technological advancements.
Cryoport's animal health strategy is based on building a strong foundation with the leading animal health firms. This strategy will allow the opportunity for Cryoport to develop additional purpose-built solutions to meet the currently unmet needs and nuances that are unique to the animal husbandry industry. We continue to build and expand our relationship with Zoetis, and we have established formal contractual relationships with Elanco and Boehringer Ingelheim during this past year.
The Animal Health industry is highly competitive with many players operating in both developed and emerging regions. Cryoport, however, is uniquely positioned to support the global animal health industry globally with key supply-chain dynamics such as the increasing value of the commodities being shipped, an increase in the number and volume of temperature-controlled products, auditable traceability requirements, and efficiency demands. Our comprehensive supply chain platform, which begins with planning and consulting to intelligent logistics, biostorage, and advanced packaging solutions, provides a true value proposition for the evolving needs of the Animal Health industry.
Reproductive Medicine
The Reproductive Medicine industry is also growing globally. In March 2023, Cryoport signed a multi-year agreement with Inception Fertility™ (Inception),
Following the quarter end, in April 2023, the Company signed a new three-year agreement with Boston IVF, a pioneer in reproductive healthcare and innovative research and one of the world's most experienced fertility treatment providers. Utilizing Cryoport's end-to-end supply chain solutions, Boston IVF will integrate its regional and satellite labs across
Financial Highlights
Total revenue for the first quarter of 2023 was
- Biopharma/Pharma revenue increased to
$51.1 million 19% or$8.1 million $43.0 million $5.0 million 28% increase compared to the first quarter of 2022. Overall, revenue growth in this market continued to be driven by the support of global clinical trials and commercially launched therapies as well as general demand for our temperature-controlled systems, logistics and biostorage services. - Animal Health revenue was
$8.9 million 30% or$2.1 million $6.8 million - Reproductive Medicine revenue was
$2.8 million $2.5 million
Gross margin was
Operating costs and expenses for the first quarter of 2023 were
Net loss for the three months ended March 31, 2023 was
Adjusted EBITDA was
Cryoport held
Outlook
The Company's revenue guidance of
The outlook for 2023 assumes a continued solid demand environment based on a steady economic environment. The Company's guidance is dependent on its current business and expectations, which may be impacted by, among other things, factors that are outside of our control, such as the global macroeconomic environment, the ongoing effects and after effects of COVID-19 related shut downs/slowdowns globally, continued supply chain constraints, inflationary pressures, the ongoing war between
Note: All reconciliations of GAAP to adjusted (non-GAAP) figures above are detailed in the reconciliation tables included later in the press release.
Additional Information
Further 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 will be provided in the Company's quarterly report on Form 10-Q for the three months ended March 31, 2023, which is expected to be filed with the SEC on May 4, 2023. Additionally, the full report will be available in 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 First Quarter 2023 in Review", providing a review of Cryoport's financial and operational performance and a general business update, will be issued at 4:05 p.m. ET on Thursday, May 4, 2023. 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.
Cryoport management will host a conference call the same day at 5:00 pm ET. The conference call will be in the format of a questions and answers session and will address questions members of the investment community have regarding the Company's reported results. A slide deck will accompany the call.
Conference Call Information
Date: | Thursday, May 4, 2023 |
Time: | 5:00 p.m. ET |
Dial-in numbers: | 1-877-550-2105 ( |
Confirmation code: | Request the "Cryoport Call" or Conference ID: 3900921 |
Live webcast: | 'Investor Relations' section at www.cryoport.com or click here.
Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software. |
The questions and answers call will be recorded and available approximately three hours after completion of the live event in 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 click here. A dial-in replay of the call will also be available to those interested, until May 11, 2023. To access the replay, dial 1-800-645-7964 (
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX), is a global leader in temperature-controlled supply chain solutions for the life sciences industry supporting life-saving cell and gene therapies across the research, clinical and commercial spectrum. With 48 strategic locations covering the
For more information, visit www.cryoport.com or follow @cryoport on Twitter at www.twitter.com/cryoport for live updates.
Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding the Company's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, those related to the Company's industry, business, long-term growth prospects, including expected growth in all of the Company's markets, plans, strategies, acquisitions, future financial results and financial condition, such as the Company's outlook and guidance for full year 2023 revenue and the related assumptions and factors expected to drive revenue, projected growth trends in the markets in which the Company operates, the Company's plans and expectations regarding the launch of new products and services, such as the expected timing and benefits of such products and services launches, the Company's belief that it is well positioned to support the expected growth of the cell and gene therapy market, and anticipated regulatory filings or approvals with respect to the products of the Company's clients. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, including as a result of the COVID-19 pandemic and its variants, supply chain constraints, inflationary pressures, the ongoing war between
Cryoport, Inc. and Subsidiaries | ||
Condensed Consolidated Statements of Operations | ||
(unaudited) | ||
Three Months Ended March 31, | ||
(in thousands, except share and per share data) | 2023 | 2022 |
Revenues: | ||
Services revenues | $ 35,836 | $ 32,910 |
Product revenues | 26,981 | 19,392 |
Total revenues | 62,817 | 52,302 |
Cost of revenues: | ||
Cost of services revenues | 19,076 | 18,718 |
Cost of product revenues | 16,669 | 11,243 |
Total cost of revenues | 35,745 | 29,961 |
Gross Margin | 27,072 | 22,341 |
Operating costs and expenses: | ||
Selling, general and administrative | 33,241 | 26,622 |
Engineering and development | 3,876 | 3,538 |
Total operating costs and expenses: | 37,117 | 30,160 |
Loss from operations | (10,045) | (7,819) |
Other income (expense): | ||
Investment income | 2,467 | 1,264 |
Interest expense | (1,509) | (1,491) |
Other income (expense), net | 4,005 | (5,017) |
Loss before provision for income taxes | (5,082) | (13,063) |
Provision for income taxes | (492) | (341) |
Net loss | $ (5,574) | $ (13,404) |
Paid-in-kind dividend on Series C convertible preferred stock | (2,000) | (2,000) |
Net loss attributable to common stockholders | $ (7,574) | $ (15,404) |
Net loss per share attributable to common stockholders - basic and diluted | $ (0.16) | $ (0.31) |
Weighted average common shares outstanding - basic and diluted | 48,362,501 | 49,660,579 |
Cryoport, Inc. and Subsidiaries | ||
Condensed Consolidated Balance Sheets | ||
March 31, | December 31, | |
2023 | 2022 | |
(in thousands) | (unaudited) | |
Current assets: | ||
Cash and cash equivalents | $ 38,538 | $ 36,595 |
Short-term investments | 484,076 | 486,728 |
Accounts receivable, net | 45,574 | 43,858 |
Inventories | 26,487 | 27,678 |
Prepaid expenses and other current assets | 9,959 | 9,317 |
Total current assets | 604,634 | 604,176 |
Property and equipment, net | 71,259 | 63,603 |
Operating lease right-of-use assets | 30,270 | 26,877 |
Intangible assets, net | 188,175 | 191,009 |
Goodwill | 151,616 | 151,117 |
Deposits | 1,218 | 1,017 |
Deferred tax assets | 937 | 947 |
Total assets | $ 1,048,109 | $ 1,038,746 |
Current liabilities: | ||
Accounts payable and other accrued expenses | $ 25,860 | $ 28,046 |
Accrued compensation and related expenses | 10,450 | 8,458 |
Deferred revenue | 1,009 | 439 |
Current portion of operating lease liabilities | 4,089 | 3,720 |
Current portion of finance lease liabilities | 114 | 128 |
Current portion of notes payable | 61 | 60 |
Total current liabilites | 41,583 | 40,851 |
Convertible senior notes , net | 407,349 | 406,708 |
Notes payable, net | 364 | 355 |
Operating lease liabilities, net | 27,841 | 24,721 |
Finance lease liabilities, net | 202 | 216 |
Deferred tax liability | 5,110 | 4,929 |
Other long-term liabilities | 368 | 451 |
Contingent consideration | 4,774 | 4,677 |
Total liabilities | 487,591 | 482,908 |
Total stockholders' equity | 560,518 | 555,838 |
Total liabilities and stockholders' equity | $ 1,048,109 | $ 1,038,746 |
Note Regarding Use of Non-GAAP Financial Measures
To supplement our financial statements, which are presented on the basis of
We believe that revenue growth is a key indicator of how Cryoport is progressing from period to period and we believe that the non-GAAP financial measures, revenue at constant currency and revenue growth rate at constant currency, are useful to investors in analyzing the underlying trends in revenue. Under GAAP, revenues received in local (non-
However, we also believe that data on constant currency period-over-period changes have limitations, particularly as the currency effects that are eliminated could constitute a significant element of our revenue and could significantly impact our performance. We therefore limit our use of constant currency period-over-period changes to a measure for the impact of currency fluctuations on the translation of local currency revenue into
Adjusted EBITDA is defined as net loss adjusted for interest expense, income taxes, depreciation and amortization expense, stock-based compensation expense, acquisition and integration costs, investment income, unrealized (gain)/loss on investments, foreign currency (gain)/loss, gain on insurance claim and charges or gains resulting from non-recurring events.
Management believes that adjusted EBITDA provides a useful measure of Cryoport's operating results, a meaningful comparison with historical results and with the results of other companies, and insight into Cryoport's ongoing operating performance. Further, management and the Company's board of directors utilize adjusted EBITDA to gain a better understanding of Cryoport's comparative operating performance from period to period and as a basis for planning and forecasting future periods. Management believes adjusted EBITDA, when read in conjunction with Cryoport's GAAP financials, is useful to investors because it provides a basis for meaningful period-to-period comparisons of Cryoport's ongoing operating results, including results of operations, against investor and analyst financial models, helps identify trends in Cryoport's underlying business and in performing related trend analyses, and it provides a better understanding of how management plans and measures Cryoport's underlying business.
Cryoport, Inc. and Subsidiaries | ||
Reconciliation of GAAP net loss to adjusted EBITDA | ||
(unaudited) | ||
Three Months Ended | ||
March 31, | ||
(in thousands) | 2023 | 2022 |
GAAP net loss | $ (5,574) | $ (13,404) |
Non-GAAP adjustments to net loss: | ||
Depreciation and amortization expense | 6,404 | 5,365 |
Acquisition and integration costs | 1,257 | 257 |
Investment income | (2,467) | (1,264) |
Unrealized (gain) loss on investments | (1,424) | 4,908 |
Gain on insurance claim | (2,642) | - |
Foreign currency loss | 157 | 160 |
Interest expense, net | 1,509 | 1,491 |
Stock-based compensation expense | 5,184 | 4,125 |
Income taxes | 492 | 341 |
Adjusted EBITDA | $ 2,896 | $ 1,979 |
Cryoport, Inc. and Subsidiaries | |||||
Total revenues by market at constant currency for the three months ended March 31, 2023 | |||||
(unaudited) | |||||
Biopharma/ | Animal | Reproductive | Total | ||
(in thousands) | |||||
Non US-GAAP Constant Currency | $ 52,284 | $ 9,133 | $ 2,841 | $ 64,258 | |
As Reported | 51,122 | 8,863 | 2,832 | 62,817 | |
FX Impact [$] | (1,162) | (270) | (9) | (1,441) | |
FX Impact [%] | (2.3 %) | (3.0 %) | (0.3 %) | (2.3 %) | |
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SOURCE Cryoport, Inc.
