Maqro Research Team Coverage
Overall strong performance, with 92% increase in revenues and 13% reduction in loss after tax despite increased investment in commercial readiness for the potential launch of RYONCIL in the US.
Key event in near-term being the potential FDA approval of RYONCIL
No specific guidance was provided.
Pg 71 of Annual Report:
- Expect management and admin expenses to remain consistent over next 12 months.
- Expect R&D expense to increase as expansion on market opportunities for late stage clinical products continues.
- R&D may decrease if MSB is able to successfully partner their late stage clinical product
- Subject to achieving regulatory approval, can expect increase in total expenses due to increases in product manufacturing, selling, general and admin expenses.
- Hence need additional capital to fund operations, which “we may raise through a combination of equity offerings, debt financing, 3rd party funding, marketing & distribution arrangements and other collaborations, strategic allicances and licensing arrangements”.
- We do not expect to generate significant revenue from product sales unless regulatory approval and commercialization takes place.
- Production capacity for TEMCELL is being increased as JCR has received orders far in excess of its initial forecast.
Balance Sheet Use:
- Cash on hand US$129.3m (as of June 30, 2020).
- Additional US$67.5m may be available through existing financing facilities and strategic partnerships over next 12 months.
- Capital will be used for:
- Commercial launch of RYONCIL for acute GVHD.
- Scale-up of manufacturing for projected increase in capacity requirements for maturing pipeline, including GVHD label extensions and COVID-19 ARDS.
- Clinical programs supporting label extension strategies and regulatory approvals of Phase 3 assets.
Remestemcel – L (RYONCIL) for Pediatric SR-aGVHD:
- ODAC of FDA voted 9-1 in favor.
- Biologics License Application (BLA) is under priority review by the FDA with an action date of 30/09/2020.
- If approved, MSB plans to launch RYONCIL in the US in Q4CY2020 in children and adolescents up to 18y.o.
- Building out efficient, targeted sales force – 15 centers account for ~50% of patients.
Remestemcel – L for Adults with COVID-19 Acute Respiratory Distress Syndrom (ARDS):
- A phase 3 randomized controlled trial is being conducted in 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS. Up to 30 leading medical centers across the US are taking part in the trial which is expected to complete recruitment during Q4CY2020.
- Scale Up – Manufacturing:
- Increase manufacturing footprint for capacity extension.
- Implement proprietary xen-free tech to increase yields and output.
- Plan for long-term move to 3D bioreactors to reduce labor and improve manufacturing efficiencies.
- Establish further manufacturing and commercialization partnerships.
Rexlemestrocel (REVASCOR) for Advanced Chronic Heart Failure:
- Phase 3 trial data readout is expected during Q4 CY2020.
Rexlemestrocel (MPC-06-ID) for Chronic Low Back Pain:
- Data readout for the 2:1 randomized placebo-controlled US Phase 3 trial in 404 patients is expected during Q4 CY2020.
- Results from the Phase 3 trials will be considered pivotal to support regulatory approval in the US and in Europe.
- Obtain clearance from European regulatory authorities to begin European Phase 3 trial.