Shares in Thrombogenics NV surged 15.5 percent during trading Monday, as the company unveiled plans to explore its “strategic options” – investment-bank speak for finding a deal or finding a buyer.
Leuven, Belgium-based Thrombogenics is throwing in the towel on its own efforts to commercialize Jetrea (ocriplasmin) in the U.S., having failed to build sales momentum for the product during its first year on the market.
The company launched the drug in January last year after gaining FDA approval on Oct. 17, 2012. Jetrea is indicated for patients with symptomatic vitreomacular adhesion, a condition caused by incomplete detachment of the vitreous gel from the retina. The problem, which is associated with aging, can lead to visual distortion and blind spots, as residual collagen fibers pull on the retina.
The only alternative treatment is surgery, which is reserved for the most severe cases. However, Jetrea sales have so far failed to keep pace with market expectations. Indeed, sales in the second half of the year actually declined. Thrombogenics said Monday that it had treated close to 7,000 patients in the U.S. in 2013. With a price tag of $3,950, that implies around $27 million in total sales.
Last August, the company reported first-half sales of €12.5 million (U.S.$17 million), based on treating 4,000 patients. It indicated then that it expected a similar result during the second half of the year.
A key issue for the company is the need to reposition the product, which was initially pitched at moderate-to-severe patients. “During 2013, it turned out that the product works well in early to mid-stage patients,” KBC Securities analyst Jan De Kerpel told BioWorld Today. That necessitated a change of audience for Thrombogenics, from retinal specialists to general ophthalmologists. “That’s where the difficulty is. The referral pattern is not established,” De Kerpel said. Moreover, the product is now facing a much larger target market, necessitating more sales muscle than Thrombogenics can muster on its own.
The company has engaged New York-based Morgan Stanley to assist in its search for a commercial ally or a buyer. For now, it is remaining tight-lipped on what its preference is – and what kind of timescale it expects the process to take. “No timing has been defined. We’ll take the time we need to do what we’re after,” Wouter Piepers, global head of corporate communications at Thrombogenics, told BioWorld Today.
De Kerpel identified Regeneron Pharmaceuticals Inc., of Tarrytown, N.J., and the Genentech unit of Basel, Switzerland-based Roche Holding AG as candidate partners, given their existing presence in ophthalmology, through their respective VEGF inhibitors, Eylea (aflibercept) and Lucentis (ranibizumab).
“If it comes to an M&A transaction, Alcon is in the best situation to buy the company,” he said.
Alcon, part of Basel-based Novartis AG, already holds ex-U.S. rights to Jetrea. Acquiring the product outright would save on a hefty 30 percent royalty rate as well as an outstanding €210 million in sales-related milestones. An M&A offer would be preferable to investors, De Kerpel said.
“From a shareholder perspective, it’s a much more clear picture.” It would also eliminate the commercial risk attached to relaunching the product in the U.S., he added.
The original Alcon licensing deal offers a ready benchmark for any prospective takers. It paid €75 million up front, with another €300 million in potential royalties, to gain ex-US rights, while the product was undergoing regulatory review. (See BioWorld Today, March 19, 2012.)
In Europe, where Jetrea’s indication is known as vitreomacular traction, the drug gained approval in March 2013. Alcon has yet to report any sales figures, given the gradual and fragmented nature of European product rollouts, but it has made progress.
“All the lights are green with respect to the European market,” De Kerpel said. Jetrea has passed health technology assessments in the UK and Germany and has been recommended for reimbursement in France. Alcon has launched the product in Canada as well, where it also has received a positive cost-effectiveness assessment.
Failure to build U.S. sales of Jetrea has weighed heavily on the Thrombogenics stock since August, when it unveiled its half-year figures and full-year forecast for Jetrea. The stock closed at €22.40 Monday, a gain of €3.64 on Friday’s close, but still some way off its one-year high of €43.39. The company, which reported €183 million in cash at Sept. 30, is now valued at €808 million. KBC has changed its recommendation from “accumulate” to “buy,” while maintaining a target price of €33 per share.