StemCell Therapy

NASHVILLE, Tenn., Nov. 4, 2021 /PRNewswire/ --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 30,2021.

Jerrell Shelton, CEO of Cryoport, commented, "We delivered an outstanding third quarter and nine months of the year for the Company with strength across the board in all areas of our business. During the third quarter, our total revenue grew to a record $56.7 million driven by 38% organic growth year-over-year from Cryoport Systems and CRYOGENE and continuing strong revenue performance by MVE Biological Solutions and CRYOPDP. Our robust performance was driven by superlative execution by our global teams across all our business units. Our markets are strong and growing. Demand for MVE Biological Solutions' products remained at record highs, Cryoport Systems added 38 new customers during the quarter, and we successfully expanded the footprints for both CRYOPDP and CRYOGENE.

"Our Biopharma/Pharma revenue increased 371% year over year in the third quarter of 2021 or 41%, organically. But the story does not end there, we now support a record 582 clinical trials, compared with 561 at the end of the second quarter of 2021 and 517 at the end of the third quarter of 2020. We also support eight commercial therapies in regenerative medicine, including Novartis' KYMRIAH, Gilead/Kite's YESCARTAand TECARTUS, bluebird bio's ZYNTEGLO andSKYSONA, Bristol Myers Squibb's BREYANZI and ABECMA and Orchard Therapeutics' LIBMELDY. Additionally, four of the approved therapies received extended or supplemental approvals in the third quarter.

"Our revenue by market for the three- and nine-months ended September 30, 2021, as compared to the same periods in 2020 was asfollows:

Cryoport, Inc. and Subsidiaries

Total revenues by market

(unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

2021

2020

% Change

2021

2020

% Change

Biopharma/Pharma

$ 46,001

$ 9,760

371%

$ 133,878

$ 27,120

394%

Animal Health

8,261

223

3598%

25,655

664

3762%

Reproductive Medicine

2,431

1,189

105%

6,635

2,551

160%

Total revenues

$ 56,693

$ 11,172

407%

$ 166,168

$ 30,335

448%

"Our solutions are experiencing accelerating global demand as a record number of cell and gene therapies are slated for commercialization in the coming months and years."

Mr. Shelton concluded, "We continue to set the pace and the standard for supply chain solutions for the regenerative medicine industry which continues to be in its very early stages of development. To support our continued global growth, we have expanded into 33 facilities in 16 countries and have initiated further expansion within the fast-growing Asia-Pacific (APAC) and EMEA (Europe, Middle East, and Africa) regions.We believe our strong momentum will continue to build through the remainder of the year and beyond as we realize the large commercial revenue potential of our vast pipeline of clinical trials supported. Our performance is a testament to the power of our strategy and our team's commitment to Cryoport and its mission, and, with that, we expect significant worldwide opportunities ahead to continue building sustainable, long-term value for shareholders."

Biopharma/Pharma

Our total Biopharma/Pharma revenue increased by $36.2 million, or 371%, to $46.0 million for the third quarter of 2021 compared to $9.8 million for the third quarter of 2020, driven by strong revenue contributions from all business units. For the third quarter of 2021, Biopharma/Pharma revenue grew organically by $4.0 million, or 41%, to $13.8 million compared to third quarter in the prior year.

As of the end of the third quarter, we supportedanettotalof582 clinical trials, compared with 561 at the end of the second quarter 2021 and 517 in third quarter 2020. The number of trials by phase and region are as follows:

Cryoport Supported Clinical Trials by Phase

Clinical Trials

September 30,

2021

2020

2019

Phase 1

240

207

180

Phase 2

272

244

191

Phase 3

70

66

54

Total

582

517

425

Cryoport Supported Clinical Trials by Region

Clinical Trials

September 30,

2021

2020

2019

Americas

459

411

360

EMEA

92

83

55

APAC

31

23

10

Total

582

517

425

A total of nine (9) Cryoport supported Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in the nine months ended September 30, 2021, based on internal information and forecasts from the Alliance for Regenerative Medicine, of which three (3) were filed during the third quarter of 2021. Looking forward, we anticipate up to another four (4) BLA and MAA submissions for Cryoport-supported products during the remainder of 2021 and, at this time, an additional twenty-one (21) filings in 2022. Additionally, a total of four (4) Cryoport supported therapies received extended or supplemental approvals in the third quarter.

Animal Health

Our revenue from the Animal Health market increased by $8.0 million, or 3,598%, to $8.3 million for thethird quarter ended September 30, 2021,ascomparedtothesameperiodin2020 andwas primarily driven byouracquisitionofMVE Biological Solutions,whichhasastrongandlongstanding presenceinthismarket. Third quarter revenue grew organically by 31% over the prior year demonstrating successful execution of our engagement strategy within the animal health space.

Reproductive Medicine

Reproductive Medicine revenue more than doubled to $2.4 million for the third quarter of 2021 compared to $1.2 million for the third quarter of 2020, an increase of $1.2 million, or 105%. We see continuing strong demand for our CryoStork solutionprovided by Cryoport Systems driven by fertility clinic networks that are looking for global standardization on our best-in-class solution. MVE Biological Solutions also contributed revenue to our Reproductive Medicine market through its portfolio of cryogenic shipper and freezersolutions. We plan to continue to add agreements with new fertility clinics to our network globally during the remainder of 2021 and beyond to drive increased adoption of our services as well as expand our support efforts within this space to EMEA and APAC.

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.

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Cryoport Reports Record Third Quarter and Nine Months Revenue for 2021 - PRNewswire

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