Canadian eye drug developer QLT Inc. has had its share of pain, with setbacks for a drug delivery system and slowing growth for Visudyne, its main drug, leaving investors to hope an experimental retinal diseases drug can get growth back on track.
Shares of the company, valued at $341-million (U.S.), are up 30 per cent since mid-August, recovering sharp losses in the wake of weak second-quarter results. The Thomson Reuters Canada Biotechnology & Medical Research Index has risen 10 per cent over the same period.
Some analysts say the company's valuation does not reflect the potential of its experimental punctal plug drug delivery technology, and QLT091001, an early-stage retinal diseases drug.
Others, however, say uncertainty over the future of Visudyne, a treatment co-developed with Novartis AG for wet age-related macular degeneration – a leading cause of blindness in people over 55 – and experimental treatments make the stock look expensive.
The plug and the retinoids program are not reflected in the valuation, so if QLT gets positive news it will be an upside for the stock, said analyst Scott Henry of Roth Capital Partners.
The punctal plug drug delivery system has tiny plugs that are inserted in the tear ducts to treat glaucoma, a disorder that affects the optic nerves.
"Punctal plug could be a success, but you don't have to pay for these drugs (at the current valuation). So, if any are successful, you're going to make a lot of money," said Mr. Henry.
QLT is targeting the $1-billion-plus eye-drop market with its punctal plug program. The retinal diseases drug, on the other hand, targets rare indications and has an orphan drug designation from the U.S. Food and Drug Administration.
Orphan drug status grants a drug maker seven years marketing exclusivity in the United States upon approval, and is for drugs that aim to treat a condition affecting fewer than 200,000 Americans.
"The current valuation is very attractive. You have downside protection from the cash level and the Eligard royalty stream, but the upside is going to be driven by the success of QLT091001," said Leerink Swann & Co. analyst Steve Yoo.
Eligard is QLT's palliative treatment for advanced prostate cancer, which some analysts say can take care of its cash flow needs for the next few years.
Mr. Yoo, who has an 'outperform' rating on the stock , said as congenital blindness is a rare disease, there is a chance the FDA might allow QLT to proceed to late-stage trials after the early stage.
Loss-making QLT traces its roots back to the creation in 1981 of Quadra Logic Technologies. It switched its focus to the ocular market in 2007, three years after buying Atrix Laboratories for $833-million.
"I don't expect Visudyne to be a robust, growing product ever again, just because of all the competition from new products," said Morningstar analyst Michael Waterhouse.
"There's a lot of competition from Lucentis, and we have another product coming out from Bayer – their VGEF Trap that is in late-stage trial," he noted.
Lucentis is Roche's drug for treating diabetic macular edema, while Eylea, from Bayer AG and Regeneron Pharmaceuticals, has sparked interest.
Mr. Waterhouse has a $5.50 (Canadian) fair price on QLT stock – a fifth below Friday's $6.89 close on the Toronto Stock Exchange – and said most of the valuation is based on the company's pipeline.
However, he assigns a 50-50 chance of success to the punctal plug program, and reckons it's too early to tell much about the prospects for the retinal diseases drug.
"Although the glaucoma market is attractive, it's their fourth mid-stage trial," Mr. Waterhouse said, adding, "It seems like they're stuck in the mid-stage trials and, even in the latest trials, still had issues with retention of these plugs."
QLT has faced problems as many of the plugs keep falling out, requiring patients to revisit their doctor to have then put back in.