Biosensors International’s BioFreedom finally gets CE Mark

All is set for next year’s full commercial launch.

According to CIMB, BioFreedom’s receipt of the CE Mark is a major step forward, potentially allowing BIG grab market shares in the European Union market first. Management anticipates full commercial launch in 2014, it said.

Here's more:

BIG announced it received the CE Mark approval for its polymer-free drug-coated stent (DCS), BioFreedom. BIG recently announced the initiation of enrolment in LEADERS FREE.

This trial will provide additional data to support the launch of BioFreedom in select markets during 2013. The full commercial launch is currently anticipated by the company to come about during 2014.

The approval was long awaited, and a subject often brought up by investors. As a reference, the BioMatrix approval in 2008 was transformational for BIG, turning into profitability over FY03/13. While it is still early days to assess the revenue and earnings outcome at this stage, we believe this would have a material impact, lifting FY14-15 numbers, similar to Biomatrix’s market shares grabbing phenomenon.

Apart from this good news, we expect BIG to make accretive acquisitions. Depending on how substantial an acquisition is, there should be potential consolidation of earnings, which we have not factored into our numbers. BIG has lagged in this market rally, now trading at 14.1x CY13 P/E, lower than most of its peers and below its three-year average forward valuations, since entering the black in FY10.

Our SOP-based target price of S$1.75 implies an above 30% upside, supported by three-year earnings CAGR of 17%. We reiterate Outperform.

Also Read

Singaporeans' physical well-being at highest level since 2019

SingHealth partners with OutcomesAI to integrate AI into medical workflows

Since you're here...

...there are many ways you can work with us to advertise your company and connect to your customers. Our team can help you dight and create an advertising campaign, in print and digital, on this website and in print magazine.

We can also organize a real life or digital event for you and find thought leader speakers as well as industry leaders, who could be your potential partners, to join the event. We also run some awards programmes which give you an opportunity to be recognized for your achievements during the year and you can join this as a participant or a sponsor.

Let us help you drive your business forward with a good partnership!

I want to download the media kit