• Strong results on BioFreedom achieved
• Targeted at PCI patients with high risk of bleeding
• Full commercial launch by this FY

BioFreedom demonstrates superior safety and efficacy vs. a BMS

Biosensors International Group recently announced that the LEADERS FREE clinical trial has demonstrated superior safety and efficacy for the drug-coated stent BioFreedomTM compared with a bare-metal stent (BMS). Eligible patients considered under the study had coronary artery disease with a clinical indication for percutaneous coronary intervention (PCI), as well as a high risk of bleeding (HBR). According to the report published in the New England Journal of Medicine, the rate of both composite primary safety and efficacy end points were “significantly lower” with BioFreedomTM than the BMS. Therefore, BioFreedomTM has the potential to benefit HBR patients who are unable to tolerate a prolonged course of dual antiplatelet therapy (DAPT).

Targeted patient group is currently not well served

According to Dr. Philip Urban, principal investigator for LEADERS FREE, an estimated 15- 20% of PCI volume in cath labs is at high risk for bleeding. Usually, this targeted subset of PCI patients are treated with either 1) the use of a BMS followed by one month of DAPT or 2) the use of a drug eluting stent (DES) but with a prolonged course of DAPT. While the latter lowers the occurrence of restenosis (repeat narrowing of the coronary artery), longer periods of DAPT increase the risk of bleeding in patients. Hence, BioFreedomTM, being polymer-free, aims to bring the best of both worlds by delivering the anti-restenotic benefits of a DES while giving a shorter (one-month) course of DAPT.

Focused on expanding geographical presence

Considered by management to be a breakthrough technology, the group will be focusing on expanding their geographical reach for BioFreedomTM, with full commercial launch in this FY. We do note that while management is working with relevant regulators to obtain a US and China FDA approval, the timeframe remain unclear. Nonetheless this set of strong evidence should help to increase confidence and adoption of BioFreedomTM. Raising our target peg from 20x to 21x P/E, our fair value estimate is raised to S$0.66 (previous: S$0.63). Maintain HOLD.

Source: OCBC Research - 19 Oct 2015