Ann: MSB Files GvHD Clinical Efficacy and Safety Data with US FDA, page-70

EDISON .....
Mesoblast
Moving closer to key catalysts
Financial update Pharma & biotech
3 January 2020
A$2.05
A$1100m
US$0.69/A$
Mesoblast is approaching some very key catalysts. The company expects to complete its filing of Remestemcel-L in pediatric acute graft versus host disease (aGvHD) in January, which if approved, will launch in 2020. For Revascor for advanced heart failure, the required accrual of primary endpoint events in its Phase III occurred in December, with data expected by mid-2020. Additionally, the last patient visit for the 24-month follow-up in the Phase III for MPC-06-ID in low back pain is expected to occur in H120 with data likely later in the year.



Remestemcel-L aGvHD filing to complete in January
Mesoblast is in the process of completing its rolling biologics license application (BLA) submission to the FDA, which it began in May. Once the filing is complete, the FDA will notify the company within 60 days of its acceptance and whether it will have a six-month priority review or a 10-month standard review. We currently expect that it will receive a priority review due to the innovative nature of the therapy and the positive safety and efficacy data in an indication with unmet need.
Revascor Phase III in heart failure readout mid-2020
The company announced that the required accrual of primary endpoint events in its DREAM HF-1 Phase III trial in 566 advanced heart failure patients has occurred. The primary endpoint is a reduction in recurrent heart failure-related major adverse cardiac events such as heart-failure related hospitalization and cardiac death.
MPC-06-ID Phase III expected to complete in H120
The ongoing 404-patient Phase III in lower back pain has completed recruitment, with the last follow-up visit expected in H120 with data coming later in the year. As a reminder, in September Mesoblast announced a partnership for the EU and Latin America with Grϋnenthal, which includes the possibility of receiving more than US$1bn in milestone payments (US$15m of which are upfront) and tiered double- digit royalties.
Valuation: A$4.2bn or A$7.91 per share
We have increased our valuation from A$4.1bn or A$7.56 per share (A$7.20 per diluted share) to A$4.2bn or A$7.91 per share (A$7.53 per diluted share) mainly due to rolling forward our NPV and lower R&D expenses. This was partially offset by lower net cash. A number of key valuation inflection points are coming up for the company in the next 12 months including a potential FDA approval and data from two Phase III trials.