MSB 1.03% 98.0¢ mesoblast limited

Regenerative Medicine OutlookA number of Cryoport-supported...

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    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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