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