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Aspreva Readies for Prime Time
By Marc Lichtenfeld
Senior Columnist
8/28/2006 10:35 AM EDT
http://www.thestreet.com/markets/marketfeatures/10305906.html

Finding a biotech company that makes money is rare, especially if it's not one of the established giants like Amgen (AMGN) , Genentech (DNA) or Gilead Sciences (GILD) .

Of the 227 stocks classified as biotech by Yahoo! Finance, only 28 of them have a price-to-earnings ratio. Why then, in a sector where investors are constantly panning for gold, is Aspreva Pharmaceuticals (ASPV) ignored when it appears to be on the verge of breaking through?

Aspreva's strategy consists of purchasing the rights to approved drugs from large pharmaceutical companies and finding new uses for them.

The company's first effort appears to be going well. In 2003, Aspreva licensed Roche's CellCept, an immunosuppressant approved to prevent the rejection of organ transplants. Since then, Aspreva has been testing the drug for use in the rare autoimmune diseases myasthenia gravis, pemphigus vulgaris and lupus nephritis, a kidney ailment afflicting lupus patients. The drug has performed well in trials and approval for all three indications is expected in 2007.

Dr. Ellen Ginzler, professor of medicine and chief of rheumatology at State University of New York Downstate Medical Center in Brooklyn, ran a trial comparing CellCept to Cytoxan to treat lupus nephritis. Cytoxan is a long-time chemotherapy agent from Bristol-Myers Squibb (BMY) that has been the standard for treating lupus nephritis.

The goal of the study was to see if CellCept was less toxic than Cytoxan. Not only did patients in the program suffer fewer side effects, CellCept performed better than Cytoxan.

With no new lupus drug in the past 40 years, the medical community already appears to be adopting CellCept. Ginzler says the drug "is already considered the first line of therapy" for people with the illness, despite the fact that it has yet to be approved in the U.S. or Europe for lupus nephritis. CellCept was approved in Malaysia last month.

Ginzler believes once the FDA gives the green light to CellCept, at least 50% of the 200,000 patients in the U.S. suffering from lupus nephritis will be prescribed the new drug.

A representative from Aspreva says roughly 70% of the company's CellCept revenue comes from lupus, with the rest stemming from the other indications and rheumatoid arthritis. In other words, this is a biotech company with $176 million of royalty revenue over the past 12 months, despite having no product approved yet.

The royalties all come from off-label uses of CellCept. During that time frame, Aspreva's net income was $100 million and cash flow totaled $32 million. Additionally, the company's balance sheet is clean with $191 million in cash and short-term investments, and lists practically no debt. Aspreva's cash on hand can cover all current liabilities.

Aspreva closed Thursday at $22.40, giving it a market cap of around $776 million. The stock, though, is trading at less than 7 times projected 2006 earnings of $3.37 a share. One hedge fund manager, who is long the stock, explains why that is. "The street is obsessed with the patent expiry," says the fund manager, who didn't want to be named. CellCept's patent is set to expire in May 2009 in the U.S. and November 2010 in Europe.

The Aspreva representative says the company isn't aware of any filings for competing products, but with $1.4 billion in worldwide sales of CellCept, the company fully expects there to be some on the horizon. Aspreva's management is working at ways to protect the patent, but there are no guarantees that they will be successful.

To continue fueling its growth, Aspreva's main objective is to partner with another company with an existing drug and repeat the same procedure it's used with CellCept. The advantages of this strategy over discovering a new compound are lower costs and an established safety profile.

With its strong balance sheet, Aspreva would also likely consider an acquisition of a similarly positioned company. Additionally, it could look to expand CellCept's label beyond the three new expected indications, although that could depend on the patent situation.

Wall Street expects Aspreva's earnings to balloon to $5.55 a share in 2008, but without a new agreement or label expansion, the consensus drops to $3.90 in 2009. Still, the stock is absurdly undervalued. Aspreva trades at less than 6 times projected 2009 earnings, while its peers are trading at a 16 multiple, according to Pacific Growth Equities.

Aspreva's management won't disclose their timetable for landing a new partnership, but obviously they know they need to put a little giddyap in their efforts. The hedge fund manager, who wished to remain anonymous, believes it's a matter of when, not if.

"They've done so well," he says. "Other people would have to note their success."
Shares of Aspreva are down from a high of nearly $35 in June as investors are likely on the sidelines, waiting for a new partnership to be announced. Once it happens or a patent extension is granted, the rush into the stock will look like the '49ers sprinting in to northern California. Profitable biotech stocks with prospects don't stay cheap for long.


 

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