If you're seeking a corporate contestant for Extreme Makeover: Home Edition, I nominate Valeant Pharmaceuticals (NYSE:VRX).
During this decade, Valeant has had four CEOs, two names, and multiple strategies. Last year, it bought and sold products and businesses with the flair of a day-trader. Sales and divestitures took place in January, March, June, and September 2008. On the flip side, it made acquisitions in October, November, and December.
Got all that? Well, there's more
Founded in 1960 as ICN Pharmaceuticals, Valeant offers a total of 389 products, taking diversity to a dizzying level. It's one thing for giants like Novartis (NYSE:NVS) or Johnson & Johnson (NYSE:JNJ) to manage a huge stable of products over many continents. It's another for a company with only $657 million in revenue to have so many products in so many territories.
How many? Brand-name drugs, generics, and the rest are sold in the United States, Canada, Australia, New Zealand, Europe, and Latin America. In fact, 63% of sales from continuing operations come from outside the U.S.
And today, the company says Valeant has a simpler structure as it tries to focus on dermatology and neurology. Uh-huh.
The question is, will simplicity lead to success?
Check the fine print
Even when Valeant succeeds, it can make Wall Street nervous. The stock is up 24% for the past 12 months, beating both the S&P 500 and the Amex Pharmaceutical Index. But look closely at that performance. For the first 11 of those months, the stock climbed 65%. In the last month, it dropped 25%. And as a longer-term (five-year) investment, Valeant's stock is down 30%. For most of that period, it trailed both the Amex drug index and the S&P 500.
Clearly, this isn't a stock for the faint of heart.
Among the handful of analysts watching the company, there are two holds, one underperform, and one sell. Further, you know there's a lot of uncertainty when the latest analyst on board initiated coverage with a sell rating.
Waiting for the big score
The latest Valeant strategy, to borrow a military analogy, combines ground forces -- generic drugs, non-prescription medications, and brand-name drugs -- with heavy artillery. However, Valeant hasn't received approval yet for the hoped-for biggest gun, retigabine, as an adjunct treatment for epilepsy.
Retigabine is touted as having a different mechanism of action than other products in the crowded epilepsy market, populated with generics and brand names such as Pfizer's (NYSE:PFE) Lyrica, Cephalon's (NASDAQ:CEPH) Gabitril, and J&J's Topamax.
Plus, it isn't moving through the regulatory process as Valeant had hoped. In May 2007, Valeant predicted it would submit an application to the Food and Drug Administration by mid-2008. By February 2008, it had pushed the filing date back to year-end 2008. Later on, in August, Valeant announced a development and marketing deal with GlaxoSmithKline (NYSE:GSK), adding that it expected to submit applications to the FDA and its European Union counterpart in early 2009.
But, much to Wall Street's chagrin, the companies recently delayed the FDA application once again. Valeant CEO J. Michael Pearson said late last month that both companies want to file an application this year, adding that GlaxoSmithKline will make the final decision.
Patrolling for partners
Like most smaller drugmakers, Valeant seeks partners to help it market and develop what it considers to be major products. It is willing to sacrifice some potential profit if it can find someone to help defray the cost of expensive late-stage clinical testing, regulatory filings, and multi-continent marketing. These deals also provide important upfront and milestone money.
Glaxo entered late in retigabine's R&D pathway, in October 2008, after Valeant had completed late-stage clinical trials.
Valeant wants, even needs, a partner to enter much earlier for its other experimental big gun, taribavirin for hepatitis C, which is completing a mid-stage trial. If Valeant can't find a partner, CEO Pearson said he won't continue the work because the company can't afford to conduct a late-stage clinical trial.
Taribavirin is supposed to have fewer side effects than ribavirin, which is used with pegylated interferons, in the standard treatment for hepatitis C. Those pegylated interferons are made by Schering-Plough (NYSE:SGP) and Roche.
Valeant discovered ribavirin, and although it sells its own brand called Virazole, it licensed rights to Schering-Plough in 1995 and to Roche in 2003. Valeant has been receiving royalty payments over the years, but the amounts have declined recently, mostly due to generic competition.
Caution ahead
So is Valeant a good investment? I would tread carefully here, Fools. With many moving parts -- all those products around the world -- and a big dose of regulatory and R&D "maybes," you have a prescription for uncertainty. Add the expected generic competition for a top performer, and there’s some reason for worry.
Although Valeant did reduce total debt some 40% last year from the $780 million-plus it's carried recently, stockholders' equity has also declined, dropping by more than 55% since the end of 2004. Plus, cash and equivalents are down to $200 million, reducing the flexibility to do things like buy back stock or make further deals or collaborations.
Valeant has to keep moving if it wants to break a streak of seven consecutive years of GAAP losses and fulfill Pearson's ambitions. Otherwise, Pearson could become the latest CEO of this company to miss with a valiant effort.
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