Regenerative Medicine Outlook
A number of Cryoport-supported clinical trials are preparing for commercialization, with two
Cryoport-supported Marketing Authorization Applications (MAA’s) or Biologics Licensing
Applications (BLA’s) submissions in the First Quarter 2020, and a third submission subsequent
to the quarter end, demonstrating the continued focus in the BioPharma market on bringing these
potentially life-saving therapies to market even in this challenging environment.
We expect this momentum to continue, with approximately six additional Cryoport-supported
MAA’s and BLA’s to be filed in 2020 based on internal information and forecasts from the Alliance
for Regenerative Medicine, albeit that the timing of a number of these may be impacted by COVID19. These filings are anticipated to be primary revenue drivers for Cryoport in the future as each
of them requires comprehensive temperature-controlled logistics and bioservices support at
scale.
11
Based on industry sources, Cryoport expects the following clients to report significant events,
such as commercial approval or BLA/ MAA filings in 2020:
• Atara
• bluebird bio
• Bristol-Myers Squibb
• Gilead/Kite
• Iovance
• Mesoblast
• Orchard Therapeutics
• Poseida Therapeutics
• Gamida Cell
Five BLA/ MAA filings that we had previously anticipated being filed in 2020 are now expected to
occur in 2021 as a result of COVID-19 delays. We now expect thirteen BLA/ MAA filings in 2021.
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