PR Newswire
NASHVILLE, Tenn., Aug. 9, 2023
NASHVILLE, Tenn., Aug. 9, 2023 /PRNewswire/ -- 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 | | | | | | | |
(unaudited) | | | | | | | |
(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:
| | | |
Cryoport Supported Clinical Trials by Phase | | | |
| | | |
Clinical Trials | June 30, | ||
2021 | 2022 | 2023 | |
Phase 1 | 227 | 260 | 273 |
Phase 2 | 265 | 285 | 313 |
Phase 3 | 69 | 81 | 82 |
Total | 561 | 626 | 668 |
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| | | |
| | | |
Cryoport Supported Clinical Trials by Region | | | |
| | | |
Clinical Trials | June 30, | ||
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.
Total 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.
Gross 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% for H1 2022.
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