MSB 2.73% $1.07 mesoblast limited

Hello All, See attached Ladenberg note as follows....

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    Hello All,

    See attached Ladenberg note as follows.

    LADENBERGTHALMANN :

    PRICETARGET CHANGE - NOVEMBER 2020

    MesoblastLtd.

    WWNovartis Agreement for remestemcel-L in ARDS Inclusive of COVID-19; Raise PT

    Yesterday,the company announced FY-Q1-2021 financial results as well as a worldwide

    licenseand collaboration agreement with Novartis (NVS, $87.20, Not Rated) for the

    development,manufacture, and commercialization of remestemcel-L.

    TheNovartis agreement will initially be focused upon the treatment of ARDSinclusive

    ofCOVID-19 ARDS and alternative respiratory conditions. Novartis will initiate a

    Phase3 trial evaluating the effects of remestemcel-L on non-COVID-19 ARDS (acute

    respiratorydistress syndrome). The trial will begin subsequent to the closing of the

    agreementand completion and readout of the ongoing COVID-19 ARDS Phase 3 trial.

    Todate, approximately 180 patients of 300 total patients have been enrolled(enrollment

    completionanticipated for CY-Q4-2020) and the independent DSMB has recommended

    continuationfollowing two of the three interim analyses. Recall, the primary endpoint is

    allcause mortality up to 30 days with a secondary endpoint of days alive offventilator

    within60 days.

    Thekey terms of the Novartis deal include an upfront payment of $50 million of

    which$25 million will be paid in equity. Further, the company could receive a totalof

    $505million contingent upon various pre-commercialization milestones related to the

    ARDSindications. In terms of post-commercialization, the company could receive upto

    $750million based upon sales milestones and tiered double-digit royalties onproduct

    sales.The company will continue to manufacture remestemcel-L for both clinical and

    commercialuses and Novartis will purchase the commercial product under agreed pricing

    arrangements.Novartis will also be required to fund any capital expenditure necessary

    toexpand manufacturing capabilities.

    Thecompany also provided an update upon the ongoing dialogue with the FDA

    regardingthe SR-aGVHD remestemcel-L BLA application. Recall, the FDA responded

    to thecompany with a CRL. The company requested a Type A meeting which was

    heldon November 17, 2020. While the definitive outcome remains unknown until the

    disbursementof the formal minutes to the company, it does not appear that the FDA

    willagree to an accelerated approval pathway with a post-approval study. Thecompany

    notedthat if the FDA definitively does not agree to the pathway, the company willrequest

    andadditional Type A meeting to initiate the FDA dispute resolution pathway. Weare

    unableto determine the timing or outcome of the FDA response at this time. We do

    recognize,however, that there remains a large unmet need as there are no current

    treatmentsfor children under the age of 12.

    Basedon our Comparable Company Valuation table, we believe that it is appropriate to

    valuethe company based on its representative peers and as such we have determined

    thatthe company’s valuation should be 12 times (previously 11 times) our FY-2023

    revenue estimate discounted by one year at 12%, or $17.25 (previously$16.00).

    Turning to the financialresults for the quarter, the company announced Commercialization

    revenue of $1.3 millionwhich is an 86% increase sequentially and 30% decrease yearover-

    year. OPEX totaled $38.9million with $19.3 from Research and Development, $11.9

    million from Manufacturing,and $7.7 million from Management and Administration. R&D

    increased 56% related tothe ongoing Phase 3 trial for COVID-19 ARDS and

    Manufacturing increased341% y/y as the company expanded manufacturing capacity and

    capabilities includingproprietary xeno-free technologies to increase output and 3D

    bioreactors to reducelabor and increase efficiencies. Net loss totaled $24.5 million and

    included a $15.1 milliongain on contingent consideration as well as non-cash items

    including stock-basedcompensation. Our models estimated revenue, OPEX, and net loss

    of $1.7 million, $31.0million, and $33.3 million, respectively.

    For MPC-06-ID andRevascor, the company provided a brief update. Recall, the company

    entered into adevelopment and commercialization partnership with Grünenthal for LATAM

    and Europe. The companyalso anticipates data from the previously completed Phase 3

    trial for chronic lowback pain in 404 patients to readout in the coming weeks. These data

    will help inform thepotential European Phase 3 trial. Additionally, the results could support

    regulatory approval inthe US.

    Revascor, the company’scandidate for advanced and end-stage heart failure, will also

    have a data readoutduring CY-Q4-2020. Recall, the study surpassed the number of

    primary endpoint eventsrequired for trial completion. As of current, the quality review is

    being completed at thestudy sites. Positive data from the study could support potential

    regulatory approval inthe US. We are highly encouraged by the company’s progress and

    recognizenumerous near-term data readouts that could acts as catalysts.


    END OF NOTE.
 
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