Full Press Release Details
Cryoport Reports Second Quarter 2023
Tennessee, August 9, 2023, - Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"), a leading
global provider of innovative products and services to the fast-growing cell & gene therapy industry enabling the future of medicine
for a new era of life sciences, today announced financial results for the second quarter (Q2) and first half (H1) of 2023.
Jerrell Shelton, CEO of Cryoport,
commented, "Today, we reported quarterly revenue results that were consistent with the preliminary results we previously provided,
which reflected significantly weaker than expected demand for capital equipment from China and slower than expected ramps from certain
clients during the second quarter.
"China's economic condition
and a significant drop in orders caused a second quarter decline in MVE Biological Solutions' China derived revenue of 67% or $5.8
million year-over-year. For the previous two years the Chinese market has represented approximately 23% of MVE's total revenue and
10% of Cryoport's overall revenue. Our leadership team has recently been to China to meet with our MVE team based there, along with
key clients, and distributors to reinforce our strengths and relationships. As a part of this effort, we have devised mitigation plans
that we believe will help to build on MVE's long-term market leading position.
"We have confidence in our
corporate strategy, and we remain steadfast that our long-term growth drivers are firmly intact, despite these short term-challenges.
Our view is informed and reinforced by the more than 20% anticipated ten-year compound annual growth rate of the cell and gene therapy
industry and the increasing number of clinical trials and commercial therapies now supported by Cryoport. In addition, a number of recent
advancements by our cell and gene therapy clients fuel our optimism, such as the FDA's (U.S. Food and Drug Administration) approval
for commercial production at Bristol Myers Squibb's new, state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts,
its acceptance of CRISPR Therapeutics/Vertex Pharmaceuticals' Biologics License Applications (BLAs) for exagamglogene autotemcel
(exa-cel) for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), and its approval of
Sarepta Therapeutics' gene therapy ELEVIDYS, for the treatment of Duchenne Muscular Dystrophy.
"In addition to these client
developments, we also continue to make strategic investments and form relationships to further enhance our growth prospects. These include
the continued build-out of our Global Supply Chain Center Network, an expanded infrastructure we are creating that provides the life sciences
industry with the most advanced solutions to ensure the safe and timely delivery of its extremely valuable, lifesaving cell and gene therapies.
Our bioservices/biostorage network revenue grew 38% year-over-year to $3.2 million in the second quarter. We are also making further strides
in the reproductive medicine industry, including recent agreements with Boston IVF and IVFAustralia as a supply chain solutions partner
to support their global reproductive material shipments.
"With these recent client
developments, new services and products and strategic relationships, we believe our future growth prospects are stronger than ever. We
are committed to continue solidifying our leadership position in the cell and gene therapy industry, which is poised for significant expansion
as it transforms the way medicine is practiced. By doing so, we will further strengthen our business and continue to position Cryoport
for long-term and profitable growth," concluded Mr. Shelton.
In tabular form, revenue by market
for Q2 2023 and H1 2023, as compared to the same periods in 2022 was as follows:
Cryoport, Inc. and Subsidiaries
Total revenues by market
| (in thousands) | Q2 2023 | Q2 2022 | % Change | H1 2023 | H1 2022 | % Change | ||||||||||||||||||
| Biopharma/Pharma | $ | 46,533 | $ | 52,591 | -12 | % | $ | 97,655 | $ | 95,601 | 2 | % | ||||||||||||
| Animal Health | 7,873 | 9,285 | -15 | % | 16,736 | 16,079 | 4 | % | ||||||||||||||||
| Reproductive Medicine | 2,615 | 2,277 | 15 | % | 5,447 | 4,775 | 14 | % | ||||||||||||||||
| Total revenues | $ | 57,021 | $ | 64,153 | -11 | % | $ | 119,838 | $ | 116,455 | 3 | % |
As of June 30, 2023, the Company
supported 12 commercial therapies and a net total of 668 global clinical trials, a net increase of 42 clinical trials over June 30, 2022
and a sequential increase of 16 clinical trials from Q1 2023. The number of trials in Phase 3 was 82 as of the end of the second quarter.
The number of trials by phase and region are as follows:
Clinical Trials by Phase
| June 30, | ||||||||||||
| Clinical Trials | 2021 | 2022 | 2023 | |||||||||
| Phase 1 | 227 | 260 | 273 | |||||||||
| Phase 2 | 265 | 285 | 313 | |||||||||
| Phase 3 | 69 | 81 | 82 | |||||||||
| Total | 561 | 626 | 668 |
Cryoport Supported Clinical Trials
| June 30, | ||||||||||||
| Clinical Trials | 2021 | 2022 | 2023 | |||||||||
| Americas | 444 | 488 | 515 | |||||||||
| EMEA | 88 | 104 | 109 | |||||||||
| APAC | 29 | 34 | 44 | |||||||||
| Total | 561 | 626 | 668 |
A total of four Cryoport
supported Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in the second quarter of 2023.
During the remainder of 2023, we anticipate up to an additional 14 application filings, five new therapy approvals and an additional
nine label or geographic expansion approvals.
Financial Highlights
Total revenue for Q2 2023 was
$57.0 million compared to $64.2 million for Q2 2022, a year-over-year decrease of 11% or $7.1 million.
revenue for H1 2023 increased to $119.8 million compared to $116.5 million for H1 2022, a year-over-year increase of 3% or $3.4 million
and 4% at constant currency. Revenue for H1 2022 was adversely impacted by approximately $9.4 million during Q1 2022 from the fire at
our New Prague, Minnesota manufacturing facility.
margin was 43.4% for Q2 2023 compared to 45.0% for the same period in 2022. Gross margin was 43.2% for H1 2023 compared to 43.9%
and expenses increased by $9.0 million, or 26% to $43.1 million for Q2 2023 compared to $34.1 million for Q2 2022. The increase was primarily
attributable to the further build out of our competencies, infrastructure, and technology development to support the continuing scaling
of our business and demand for Cryoport's systems and solutions and the evaluation of acquisition opportunities. Operating costs
and expenses increased for H1 2023 by $15.9 million, or 25% to $80.2 million compared to $64.2 million for the same period in the prior
Q2 2023 and H1 2023 was $18.4 million and $23.9 million, respectively, compared to a net loss of $9.2 million and $22.6 million for the
same periods in 2022, respectively.
Net loss attributable
to common stockholders was $20.4 million, or $0.42 per share, and $27.9 million, or $0.58 per share, for Q2 2023 and H1 2023, respectively.
This compares to a net loss attributable to common stockholders of $11.2 million, or $0.23 per share, and $26.6 million, or $0.54 per
share, for Q2 2022 and H1 2022, respectively.
EBITDA was a negative $1.5 million for Q2 2023, a decrease of $7.5 million year-over-year. Adjusted EBITDA for H1 2023 was $1.4
million compared to $8.0 million for H1 2022.
$504.7 million in cash, cash equivalents, and short-term investments as of June 30, 2023.
reconciliations of GAAP to adjusted (non-GAAP) figures above are detailed in the reconciliation tables included later in the press release.
Cryoport's revenue for the
full year 2023 is expected to be in the range of $233 - $243 million. The Company's 2023 guidance is dependent on its current business
and expectations, which may be further 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, volatility in the China economy, the ongoing war between Russia and Ukraine, economic uncertainty and the effects
of foreign currency fluctuations, as well as the other factors described in the Company's filings with the Securities and Exchange Commission
("SEC"), including in the "Risk Factors" section of its most recently filed periodic reports on Form 10-K and Form
10-Q, as well as in its subsequent filings with the SEC.
Additional Information
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 the Company's Quarterly Report
on Form 10-Q for the three months ended June 30, 2023, which is expected to be filed with the SEC on August 9, 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.
Conference Call Information
INFORMATION: In addition to the earnings release, a document titled "Cryoport Second 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 Wednesday,
August 9, 2023. The document is designed to be read in advance of the questions and answers conference call and will be accessible at
Cryoport management will host
a conference call at 5:00 p.m. ET on August 9, 2023. 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: | Wednesday, August 9, 2023 |
| Time: | 5:00 p.m. ET |
| Dial-in numbers: | 1-888-886-7786 (U.S.), 1-416-764-8658 (International) |
| Confirmation code: | Request the "Cryoport Call" or Conference ID: 85344190 |
| 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 August 16, 2023. To access the replay, dial 1-844-512-2921