ThromboGenics starts Jetrea roll-out in USA
With the launch of its Jetrea (ocriplasmin) in the USA imminent, Belgian drugmaker ThromboGenics (Euronext Brussels: THR) has seen upward activity in its share price, likely reflects expectations for premium pricing and with this now achieved, focus shifts to launch dynamics, note analysts at Edison Investment Research.
Product launches can be difficult to forecast accurately, and the share price suggests high expectations. However, a positive European Union recommendation in coming weeks is likely to provide near-term support, they say.
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Jetrea received US approval last fall (The Pharma Letter October 19, 2012) for the treatment of symptomatic vitreomacular adhesion (VMA). ThromboGenics plans to commercialize the product itself in the USA with launch confirmed to commence yesterday (January 14). The US price per injection is $3,950, a 30% premium to prior $3,000 guidance, although management had previously indicated this could be conservative.
US launch dynamics the key share price driver
The approved label for Jetrea is broad, with no restrictions on use in either macular hole or macular pucker/epiretinal membrane (scarring of the back of the eye). The around 30 US sales reps will initially target retina physicians that treat vitreomacular adhesion (VMA). Until now, the only treatment was invasive surgery. A permanent J-code will not be available until January 2014, with the temporary Q-code potentially increasing the administrative burden for use in the first 12 months.
The analysts says that ThromboGenics’ management expects a Committee for Medicinal Products for Human Use(CHMP) opinion this month, with the meeting scheduled January 14-17, which would allow for formal European Medicines Agency approval during March this year and potential launch in the second quarter of 2013, in line with expectations. Following US approval, this is now largely de-risked but nevertheless could offer upside.
Enterprise value of 1.5 billion euros
ThromboGenics’ shares have more than doubled in the last 12 months following a licensing deal with Alcon and a successful Jetrea US regulatory review. Its end September 169 million-euro ($225.5 million) cash suggests an enterprise value of nearly 1.5 billion euros, the analysts believe. With EU approval now largely de-risked, expectations for market launch are high, with initial dynamics likely to dictate share price performance.
For 2011, ThromboGenics generated revenues of 2.5 million euros, with a pretax loss of 21.6 million euros. The Edison analysts say that consensus estimates indicate 2012 revenues of 75.1 million euros and a pretax profit of 20 million euros, growing to 130.0 million euros and 67.1 million euros, respectively for full-year 2013.