Pfizer Might Finally Move to Help Cushion Lipitor Blow

The relatively new CEO at drug giant Pfizer (PFE) has been focusing on cost cutting, not major acquisitions, since he arrived but investors have wanted more. The company's blockbuster cholesterol treatment, Lipitor, represents 25% of Pfizer's $48 billion in annual sales, but the drug faces patent expiration in 2011. Fears over how the company would replace such a loss has been hampering its share price for a long time. Despite a dividend yield north of 7%, investors have been uninspired, as the stock only fetches 7 times 2008 expected earnings.

We now hear that Pfizer is in talks to acquire Wyeth (WYE) for about $60 billion. While most large deals are met with initial skepticism (Pfizer shares are down in pre-market trading to $16 and change) a large deal is very important for an industry facing large scale patent losses and limited R&D pipelines. If this deal does come to fruition, it shows that Pfizer management actually did have a plan, they just weren't going to be rushed into it by Wall Street. With a P/E of 7 and a dividend yield of 7.5%, Pfizer shares are very cheap and at the very least have limited downside. If the Wyeth deal happens and works well, the announcement of the deal could easily mark the bottom in the stock.

Full Disclosure: Peridot Capital had a long position in Pfizer at the time of writing, but positions may change at any time

Election Worries Have Put HMO Stocks Like United On Sale

Owning healthcare stocks in an election year, especially one in which universal healthcare has taken center stage on the Democratic agenda, is not surprisingly a wild ride. With less than six months to go until our country chooses its next president, near-term headline risk for healthcare stocks should stay elevated for a while. That said, some healthcare names, most notably the health insurance providers, have seen their share prices get beaten down to levels that can't help but get value investors' attention.

A perfect example is United Healthcare (UNH), one of the largest health insurance providers in the country. The combination of political risk and a recent acceleration in healthcare cost inflation have investors nervous. The stock has fallen from a high of more than $59 in December and hit a new 52 week low on Thursday, trading below $32 per share. This dramatic 45 percent decline leaves UNH trading at merely 9 times trailing earnings. Such a meager valuation indicates that Wall Street is genuinely concerned that a Democrat in the White House could cripple the fortunes of the HMO industry.

History has shown, however, that wide sweeping changes are rarely accomplished in Washington DC, especially when the issue is as complicated as the broken U.S. healthcare system. Even small, productive changes are difficult to attain when politicians and lobbyists are involved in decision making that is trying to make life better for the American electorate. In other words, using history as a guide seems to indicate the current pessimism on Wall Street regarding the HMO industry may prove to be overdone. The near term headlines could very well spook investors further as the election approaches, but getting arguably the best managed HMO company in the country for 9 times trailing earnings looks like it could turn out to be quite a bargain.

Don't get me wrong, I would like to see transformative healthcare reform in this country as much as anyone. I simply don't think the political environment as it stands currently has a very high probably of accomplishing such a magnificent feat.

Full Disclosure: Long shares of United Healthcare at the time of writing 

Merck's First Quarter Report Substantiates View of Vytorin Overreaction

Back in February I wrote that Vytorin worries looked overdone and concluded that Merck (MRK) shares especially looked attractive. Since then the stock has dropped further (MRK is down 32% year-to-date as shown by the chart below), but yesterday's earnings report from the company leaves my prior view unchanged.

Merck reported first quarter earnings of $0.89 per share, three cents above estimates. They also reiterated their 2008 profit view of $3.33 per share. So, MRK shares have lost a third of their value this year but Vytorin losses are not expected to meaningfully impact their earnings. Such a dichotomy makes me even more confident of my previous assertions.

Merck has lowered its 2008 projections for its share of income from the cholesterol joint venture which sells both Vytorin and Zetia by $700 million to account for the negative ENHANCE study results. While it may be too early in the year to know exactly if such a cut is enough, the fact that a $700 million hit leaves earnings guidance unchanged shows that Merck is not overly dependent on these two products.

In fact, being conservative and using the company's low end of guidance for the joint venture, these two drugs will only represent 9% of Merck's 2008 sales. Given they can adjust their cost structure (staff, marketing, manufacturing capacity, etc) quickly to reflect lower revenue expectations, it is not difficult to see how $700 million can have only a modest impact on overall profitability.

Merck shares today fetch $39 each, down from $57 at the outset of the year. The stock trades at less than 12 times this year's expected earnings and yields about 4%. Yesterday's report did nothing to sway my view from back in February. The MRK sell off still appears overdone.

Full Disclosure: Long shares of Merck at the time of writing

Vytorin Worries Look Overdone in Shares of Merck, Schering

The drug sector has been a tough place to invest in recent years as the FDA has become more and more strict, not only in approving new drugs but also with respect to labeling requirements for existing ones.

Last year, new warning labels essentially crippled the anemia drug franchise at Amgen (AMGN), and a recently released study for Vytorin, a cholesterol drug from Merck (MRK) and Schering Plough (SGP), has investors worried. The market has slammed the two stocks, after study results showed that Vytorin (a combination drug composed of Zocor and Zetia) was no more effective than Merck's Zocor in reducing the risk of heart disease. This is important because Zocor is available in generic form, while Vytorin is a new, more expensive medication.

Zetia and Vytorin, both products of a cholesterol joint venture between Merck and Schering, netted the two companies about $5 billion of revenue in 2007, but that business is coming to question. If Vytorin is not as helpful as the companies have been claiming, scripts could move heavily toward generic Zocor and significantly impact the profits derived from the joint venture.

One of the more interesting things about this story is that the drug trial in question (called "Enhance") actually did show that Vytorin was better than generic Zocor at reducing levels of so-called "bad" cholesterol. That important point has been widely ignored, however, because of worries that Merck and Schering have been touting Vytorin's ability to perhaps slow progression of disease. If marketing materials have to tone down their claims, Vytorin sales would be hurt.

All of this said, there are always drug studies that show less positive effects than others. Not every patient sees benefit from a drug, but just because some people do and others don't does not mean these drugs should be pulled from the market. Often times drug companies don't even know exactly why drugs work, let alone why they do for some people and don't for others. As long as some patients see benefits, their doctors will likely still prescribe them.

The FDA has gotten very strict about studies that show possible harm to patients, even if it is in very small numbers. The important thing about the Vytorin study is that not only is the drug not harmful, but it still is better than the generic at reducing cholesterol. As a result, this trial is not going to result in Vytorin being pulled from the market. Rather, it will likely lead to some people who found success on generic Zocor going back to it, with the belief that paying the extra money for Vytorin might not be worth it. For those who see lower cholesterol levels with Vytorin, there is no reason to think they will stop taking the medication.

The stock prices of Merck and Schering, meanwhile, have gotten absolutely crushed as this news has come out. The cholesterol joint venture accounts for 20% of sales for Schering Plough and 10% for Merck. With Schering's recent acquisition of Organon Biosciences, that number should drop to 15% in 2008. Meanwhile, SGP shares are down 25% since the news hit, with MRK dropping 20%. In total, the two companies have lost $35 billion in market value despite the drugs generating only $5 billion in annual sales. Even if both are pulled from the market (unlikely given what we know so far), the reaction would be overly harsh.

As a result, both of these stocks look like steals for long term investors. A pretty dramatic drop in scripts would still likely result in maybe a 50% decrease in Vytorin and Zetia sales, which amounts to $1.25 billion for each company. It appears that the dog's bark in this case is likely to prove much louder than its bite. I'm not saying this study is a non-issue, I merely think the market value loss we have seen is assuming much more of a profit deterioration for these two companies than is likely to occur.

In my view, based on current prices, Merck gets the slight nod over Schering for the following reasons:

1) Strong developmental product pipeline relative to the industry

2) Less of its core business relies on the cholesterol joint venture

3) Higher dividend yield (3.3% for MRK vs 1.3% for SGP)

4) Potential for incremental generic sales gains when some patients inevitably switch from Vytorin to Zocor (a Merck product)

Full Disclosure: Long shares of all the companies mentioned in this piece at the time of writing

With Growth Stocks Seeing Multiples Compress, Investors Should Make a Shopping List

Even though the market has done well this year, It has been interesting to see so many former high flying growth stocks come back down to earth. Over the last few years there was always a group of great companies that were growing like weeds and their share prices reflected those prospects. If I think about the premier growth companies of the last five years, names such as Starbucks (SBUX), Whole Foods Markets (WFMI), Genentech (DNA), and eBay (EBAY) come to mind but there are dozens of others as well. These stocks had traded at 40 times earnings for a long time. Momentum growth managers scooped them up, but others were wary of the high P/E multiples, and that caution proved to be correct.

Not surprisingly, these stocks have underperformed as multiple compression has taken place. I even wrote about Starbucks back in late 2004, in a post entitled Sleepless in Seattle, warning investors that even if the company continued to grow, the stock might not. The coffee giant, along with the other companies mentioned above have in fact treaded water or are hitting new lows lately. At some point, though, the stocks will look attractive. Starbucks isn't worth 40 times earnings, but maybe it is worth 20 times. Same with the other names. As former growth stars come down, investors should decide if they would like to own any of these companies, and if so, at what price. If things keep going in this direction, there might be entry points over the next year or so.

Do any of the four aforementioned companies grab my attention at current prices? After all, they now trade at between 20 and 24 times 2008 earnings projections. One jumps out at me in particular, Genentech. A 21 forward P/E seems very reasonable for a leading biotech company that can likely grow earnings 15 to 20 percent annually for the next five years. As you can see from the chart below, the stock has treaded water for two years now as the multiple compressed by more than 50%. Growth investors might want to take a look.

In general, it appears many growth stocks that were once wildly overpriced are getting more reasonable. I would suggest investors who once passed on a name or two due to valuation reexamine those companies again. Decide whether you still would like to own them or not. If so, make a shopping list complete with purchase targets and monitor them. You might find some bargains.

Full Disclosure: No positions in the companies mentioned

Amgen Announces Another Acquisition

If you wondered what Amgen (AMGN) would do with the extra $1 billion it raised through a recent bond offering, now we know what they had in mind when they finalized the numbers. The company issued $4 billion of debt and simultaneously announced a $3 billion share buyback. It appears the extra $1 billion will be used for acquisitions.

After buying Ilypsa for $420 million on June 4th, Amgen announced Wednesday it would buy Alantos Pharmaceuticals for $300 million in cash, raising its shopping spree to nearly three-quarters of the available billion dollars. As I've said before, I think these small deals make sense for the company. If even one of them results in a significant product approval in the next few years it will be well worth the investments they have made.

Full Disclosure: Long shares of Amgen at the time of writing

In the Face of Adversity, Amgen Buys Ilypsa to Bulk Up Product Pipeline

It has been a tough year for Amgen (AMGN) but the world's largest biotechnology company is not standing still while its anemia drug franchise is under attack. After cutting operating expenses by hundreds of millions of dollars and issuing $4 billion in debt to boost its share buyback program, the company announced yesterday that it will acquire privately-held Ilypsa for $420 million in cash. Ilypsa, based in San Francisco, specializes in renal care drug discovery, an area that fits very well into Amgen's existing business.

Strategic acquisitions are the third act that shareholders should want to see after an FDA panel started a process of pulling the reins on Amgen's anemia drug business. The reduction in operating expenses and the share buyback will help tremendously in buoying the stock price short term should it lose significant Aranesp sales due to stronger warning labels proposed by the FDA and more stringent reimbursement criteria from the government. Getting new drugs to market is also an important longer term step Amgen must focus on to get back on track, and this acquisition is the kind of thing that could help them do that.

That said, it will take some time to determine if the Ilypsa purchase pays off. The company's lead compound (for patients with chronic kidney disease) is in phase two trials, with a handful of other potential products slightly further behind (another product will enter phase one this year). Still, Amgen needs to take some risks. Until recently, Amgen was able to ride the coattails of its wildly popular (and profitable) anemia franchise. However, as happens quite often when success is achieved, some people believe you are making too much money at their expense.

As far as Aranesp is concerned, targeting and trying to discourage off-label use due to potential negative health implications makes sense. Amgen won't refute that, although they will lose a small amount of revenue from such an objective. What has been disconcerting is that some people are taking the task too far and it could result in the government not paying for the drugs in situations where there is no evidence that there are elevated health risks. That is just something that Amgen is going to have to fight the best it can.

The reaction on Wall Street has been harsh, but that should not come as a shock given how Wall Street acts at the first hint of bad news. As time goes on I continue to believe that the financial implications will be far less detrimental than many think. With patients who are reacting well to treatment, in situations when they are using the drug as directed (which has been proven safe), I don't think we will see dramatic changes in the way doctors prescribe the drugs. There will surely be lost revenue as off-label use is curtailed, and to a larger extent if the government follows through and discontinues coverage for some patients who are using the drugs as intended.

However, Amgen has cut nearly $1 billion from its annual operating expense budget and will be aggressively buying back stock in coming months. If these actions can put a floor in the company's earnings in the short term (Amgen will give updated guidance in July but recently reiterated their 2007 projections in an SEC filing), and their product pipeline delivers with help from acquisitions like the just-announced Ilypsa deal, Amgen shareholders should see better days.

Full Disclosure: Long shares of Amgen at the time of writing

Amgen Dependence on Aranesp Off-Label Use Greatly Exaggerated

I touched on the issues Amgen (AMGN) is having with Aranesp a couple months back, but I decided to take a closer look at the numbers after the latest news that an FDA panel recommended further studies and label changes for the company's anemia drug franchise. Such recommendations should not have been surprising given that a label change was already in the works (albeit less severe) and companies do follow-up studies on existing drugs all the time to measure long-term effects. Is the company going to lose as much business as Wall Street seems to be pricing in? I decided to take a look.

The main concern with Aranesp is that the drug is approved for patients with hemoglobin levels below 12. However, there is off-label usage going on at higher levels, and the FDA is concerned that such usage may increase cancer patients' risk of developing other health problems. Amgen stock has been crushed on these concerns.

The media and Wall Street community has been focused on the fact that Amgen's two anemia drugs, Aranesp and Epogen, represented 46% of the company's sales in 2006. If you leave the analysis at that, then dramatic changes in prescription trends for both drugs would appear quite damaging. However, if you dig further to single out the areas of concern, you learn that Aranesp sales in the United States (where the FDA and label changes will have an impact) represent less than 20% of Amgen's business. Recommendations for Epogen (which is used in dialysis patients) is not going to be known until later this year. Furthermore, off-label use is an extremely small percentage of total script volume, so even if Amgen loses all of that business, it won't be catastrophic, as the chart shows (data courtesy of Amgen).

The FDA panel was focused on patients with chemotherapy-induced anemia (CIA) and anemia of cancer (AoC), and especially with off-label uses in those with hemoglobin levels above the targeted range of 11-12. As you can see, only 15% of Amgen's sales in 2006 came from cancer patients taking Aranesp, and less than 3% came from off-label use.

Now, does this information warrant such a dramatic sell-off in the stock? It depends on how much business you assume Amgen is going to lose. If Aranesp revenue was going to go away all of the sudden, then yes, it would be very painful news for Amgen. But doctors are not going to stop prescribing the drug to most patients because the vast majority are using it as intended.

If we make some reasonable assumptions, not allowing Wall Street's reaction to influence our thinking, we can come to a much more logical conclusion about Amgen's future. Let's assume Amgen loses all of its sales from off-label use. If the FDA issues similar recommendations for Epogen in the fall (which seems likely), that would result in a 5% hit to Amgen's annual revenue. We can further assume that some on-label scripts will be lost due to some doctors getting nervous, combined with some who have borderline high hemoglobin levels and choose to cut back just to be safe.

Even if we assume that on-label sales drop off by a substantial 25% for both drugs (which seems like a high number to me), Amgen will see an overall sales drop of 10 to 15 percent. They would likely be able to offset some of that with cost-cutting, as they indicated they will do in their last quarterly conference call. The overall effect on earnings might only be 5-10 percent. Meanwhile, the stock is down nearly 30 percent, and may even be putting in a double bottom around $55 per share.

Full Disclosure: Long shares of Amgen at time of writing

Merck Does Investors a Favor

Shareholders in Merck (MRK) must be breathing a sigh of relief. An FDA panel voted 20-1 against approving Arcoxia, the company's experimental arthritis pain killer, but the stock rallied $1.50 in after-hours trading Thursday night. Why such enthusiasm? Merck just happened to announce an increase in earnings guidance for 2007 right after news of the FDA committee's decision hit the wires.

While many companies fail when it comes to looking out for investors, Merck deserves kudos for the timing of this announcement. An increase in 2007 guidance to $2.80 per share, versus current consensus estimates of $2.65 is more than enough to reverse the stock's direction short term. Had the company waited until later in the month to announce the profit projections, the stock likely would have just recouped the losses suffered due to the FDA decision. Now, investors get a higher stock price despite the overwhelming angst over Arcoxia.

Now, one could argue that Arcoxia was not expected to be approved, so perhaps the stock would not have fallen very much. After all, the drug is a Cox-2 inhibitor, same class as Vioxx. However, by timing this announcement the way they did, at the very least it tells shareholders that the company does have its share price on the radar screen. That is a lot more than many public companies these days can say.

Should you go out and buy the stock hand over fist? That might be a bit extreme. Merck trades at 17 times the updated 2007 profit estimate. That seems about right to me. Throw in the 3.3% dividend yield and you have large cap stock that I would characterize as a solid hold, especially if the market's jitters from last month come back later in the year, but not something you need to be throwing fresh money at all of the sudden.

Full Disclosure: No position

The Rising Cost of Healthcare Taken To Another Extreme

LOS ANGELES, March 26 (Reuters) - Shares of Alexion Pharmaceuticals Inc. (ALXN) rose more than 9 percent on Monday after the company told analysts that its treatment for a rare blood disorder would be priced at $389,000 per year.

The drug, Soliris, was approved earlier this month as the first product to treat paroxysmal nocturnal hemoglobinuria (PNH), a condition that affects fewer than 200,000 people in the United States.

"We considered many factors when establishing a price for Soliris. These included the rarity of this disabling and life threatening disease, the compelling clinical benefits that PNH patients experience with Soliris ... the cost of discovery, development and production, and of ongoing research ...," David Keiser, the chief operating officer said on the call.

The company's shares rose $3.71 to close at $43.78 on Nasdaq.

Imagine you are one of those approximately 200,000 people in the U.S. who have PNH. Finally, a drug has been approved by the FDA that may help you tremendously. You would likely be exuberant, for a little while anyway, until you learned how much the drug will cost. And that price is at the wholesale level.

This isn't a political blog, so I'm not going to get into a discussion about what our country should do about healthcare costs that are spiraling out of control. No matter your view on the subject, investors should realize that until something changes, until a drug that is the first one approved to treat a condition doesn't cost $389,000 per year, healthcare companies are probably going to have an easy time making money.

Some people won't care, some people will be outraged and refuse to buy a stock like Alexion, and others will be outraged but will also separate their inner beliefs and politics from their investment strategy for the sake of reaching their financial goals. I have no opinion on the investment merit of Alexion stock, as I haven't done work on it. It's no shock though that it reacted well to this news.

Full Disclosure: No position in the company mentioned at the time of writing