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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (11988)6/9/2004 11:04:50 AM
From: Biomaven  Respond to of 52153
 
Interesting commentary on pharma by Jubak on TSC:

Investors at Risk in the Drug Sector
By Jim Jubak
MSN Money Markets Editor
6/9/2004 7:38 AM EDT
URL: thestreet.com

Just when you think drug stocks should be perking up, they're headed back to sick bay with a bad case of the blahs.

From May 4 through June 4, for example, Pfizer (PFE:NYSE) was down 2%, while Eli Lilly (LLY:NYSE) was flat, and Merck (MRK:NYSE) climbed 2%.

The performance is even more mysterious because this market is just about tailor-made for drug stocks. In volatile, uncertain times, investors historically flock to the rock-solid earnings growth and dividend yields of the drug stocks.

In fact, drug stocks are behaving so contrary to history right now that I think it's worth considering the possibility that history itself is broken. I don't mean in any kind of Terry Pratchett/quantum physics kind of way; it's just odd that drug stocks seem riskier than they used to be. If that's the case, then these stocks should trade at lower valuations now and going forward than they have in the past.

Skeptical? Well, let's focus on Pfizer to test my theory. I think this is the best stock to own in the drug group.

Start with current valuations. Drug stocks, as a whole, certainly aren't expensive on a historical basis. The group trades at just 18.5 times projected 2004 earnings per share. And names such as Pfizer are even cheaper. According to Friedman Billings Ramsey, earnings will grow at an average annual rate of 16% a year from 2003 through 2007, but Pfizer trades at just 17 times projected 2004 earnings.

Raging buy, no? After all, historically, we're getting near some pretty impressive lows: Pfizer's low price-to-earnings ratio for the last five years is 16.4. Looking at history, Pfizer hasn't finished a year with a price-to earnings ratio in the teens since 1994, when it ended at 16.1. And remember that Wall Street is projecting that Pfizer will grow earnings by 21% in 2004.

But the stock isn't a raging buy if the risk that Pfizer won't meet those projections is higher than in the past.

I think there's good reason -- actually five good reasons -- to believe that current risk at Pfizer (and for much of the rest of the drug sector, for that matter) is higher now than it has been in the past.

Pipeline competition is more intense. Blockbuster drugs can't count on having the field to themselves for very long. Take Pfizer's newest potential blockbuster drug, torcetrapib. Torcetrapib belongs to an entirely new class of drugs known as CETP inhibitors that are effective in raising HDL, the good cholesterol.

Pfizer and others believe that raising good cholesterol saves lives. Pfizer plans to use the argument when it files for approval for torcetrapib with the Food and Drug Administration in late 2006 or early 2007. If Pfizer wins approval for the drug and can then combine it with its existing Lipitor drug that lowers LDL or bad cholesterol, then the company will be able to extend the life of its Lipitor franchise.

Plus, it can take huge chunks of market share from Merck's Zocor and AstraZeneca's (AZN:NYSE ADR) Crestor drugs. But competition for torcetrapib isn't far behind. Japan Tobacco has a drug, JTT-705, that also raises good cholesterol. The drug is now in phase II trials, and Japan Tobacco is now shopping the drug to potential partners because the tobacco company doesn't have the capacity to develop the drug on its own.

The cost of developing a drug has soared. Developing a drug from scratch now costs about $800 million. About 90% of all promising drug compounds fail on the way to market. In 2003, for example, Merck dropped four drugs in development, including two in phase III trials, the last step before a drug goes to the FDA for approval. Some Wall Street analysts had pegged these as potential blockbusters. This high attrition rate means that the few successes almost have to reach blockbuster status to make the research, development and marketing effort pay off.

Sometimes, the drug industry sounds a little too much like the blockbuster-fixated movie industry. That comparison isn't meant as a compliment. Take Pfizer's bet on torcetrapib. The company has budgeted $800 million just for the human tests of the drug. That's because the company is making the risky bet that torcetrapib could restructure the whole market for cholesterol drugs. There's no doubt that torcetrapib raises levels of good HDL cholesterol, but there's very little clinical evidence that raising HDL offers a significant health benefit. To get FDA approval, Pfizer will have to do the kind of long-term studies of patient health that run up a huge bill very quickly. If the bet pays off, Pfizer will have the drug industry equivalent of The Lord of the Rings. If not, think The Hulk or Van Helsing.

Demographics have become a double-edged sword for the drug companies. An aging U.S. population has meant rising drug consumption, and that has been good for drug company sales and for the prices of drug company stocks. Think how often you've heard the argument that buying drug stocks was the best way to profit from the aging of the baby boom generation. But health care costs have now hit the point where current trends are clearly not sustainable. Costs for the largest piece of Medicare, hospitalization insurance, will exceed the program's income from taxes, gains on trust assets and consumer premiums by 2018.

Drug prices are an easy target for politicians looking to "fix" the system. Let's say you're a reasonably dedicated politician looking to control government spending on health care because you know the current system is in trouble. So you propose:

Limits on the number of voters who can get care under government programs

Limiting the amount of care each voter gets

Cutting the profits of drug companies

The drug companies managed to put off the day of reckoning in the bill that passed the Medicare drug benefit. But a majority of U.S. voters are in favor of allowing the government to negotiate lower drug prices, a practice banned in the Medicare drug legislation. So it's likely that the drug industry will have to give up some ground -- legalizing the importation of "cheaper" foreign drugs and greater emphasis on generics, for example -- by 2006, when the government share of the U.S. drug market will rise to 50%. The final step could be congressional repeal of the language that currently bans government negotiation to lower drug prices.
Don't Sell; Just Be Aware of the Risk

This doesn't mean you should go out and sell all your drug stocks and never touch the sector again.

It does mean that you should take another look at your expectations for returns from these stocks and make sure that you're prepared for more risk in these shares in the future.

Let me show you how these five risk factors play out with Pfizer.

Remember the bullish case from Friedman Billings I mentioned earlier? According to Friedman Billings' investment research, Pfizer will grow earnings per share at an annual average of 16% a year from 2003 through 2007.

Today, you can also find solid Wall Street analysts who believe that by 2007 Pfizer's organic growth -- that is, growth before any future acquisitions -- will have dropped to zero.

A range of difference of opinion that big is highly unusual for a drug stock, history says, especially for an industry-leading drug stock like Pfizer. All things being equal, the greater the difference in the bull-and-bear cases, the riskier the stock.

You can find that increased risk in analyst estimates for 2004 and 2005 earnings, too. For 2004, the consensus estimate is $2.12 a share, or growth of 21.4%. The high estimate at $2.15 means growth of 22.9%; the low at $2.07 equals 18.3% growth, still very respectable. Paying the current multiple for even that worst-case 18.3% growth seems reasonable.

But go out a year further, and the spread of opinions widens. (That's typical of projections as they get further away in time, but the degree of the change in the spread is unusually large for this sector right now.) The consensus is for just 11% growth with a high of 17% and an actual decline of 2.8% at the low end. Today's multiple isn't reasonable for a stock that's looking at falling earnings per share in 2005.

These are estimates, and all of them could be wrong. I think that the estimate of zero organic growth in 2007 is wrong and that something like 11% average annual growth for 2003-2007 is about right. If that is correct, then I still want to hold Pfizer for the long term.

At the same time, I do have to recognize the possibility that drug stocks won't deliver this kind of steady growth is higher than it ever has been. And if that steady growth is less certain, I should pay less for it.

So if you're a long-term investor in Pfizer, I think it's reasonable to hold onto the shares. But I would take a pass on adding more until the rhetoric heats up as we go into the November election. If you're a short-term investor, I'd take profits here and look to get back in the fall.
Changes to Jubak's Picks

Sell Pfizer. I'm selling Pfizer out of Jubak's Picks, with its time horizon of 12 to 18 months. The next six months aren't likely to be very hospitable for drug stocks as drug prices get a lot of attention from politicians in the run-up to November's election. It's time to give Pfizer a rest and see if the fall brings an opportunity to repurchase at a lower price.

I'm selling the position with a 14% loss since I added the stock to Jubak's Picks on Aug. 24, 2001. The last year has been much kinder; the stock has returned more than 18% over that period. (Full disclosure: I will sell my shares of Pfizer on June 11.)

At the time of publication, Jim Jubak owned or controlled shares in the following equities mentioned in this column: Pfizer. He does not own short positions in any stock mentioned in this column. Email Jubak at jjmail@microsoft.com.


Peter



To: Biomaven who wrote (11988)6/9/2004 11:17:23 AM
From: bob zagorin  Respond to of 52153
 
interesting preclinical news IMO

New Reports of Cancers Linked to Abnormal Hedgehog Pathway Signaling
Wednesday June 9, 8:55 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 9, 2004--Curis, Inc. (NASDAQ: CRIS - News), a therapeutic drug development company, today announced that three new independent studies have been published that link the growth of prostate cancer, pancreatic cancer, and colorectal cancer to abnormal expression of the Hedgehog signaling pathway. The Hedgehog signaling pathway is a regulatory mechanism used by the body to control the normal development and growth of tissues and organs.
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Several years ago, scientists at Curis developed the hypothesis that certain cancers may be using abnormal expression of the Hedgehog pathway as a means of providing tumors with certain factors that support tumor growth. Since that time, several types of cancer have been linked to abnormal Hedgehog pathway activation. These include basal cell carcinoma, small cell lung cancer, medulloblastoma, pancreatic cancer, gastrointestinal cancers, and others.

The first report, in the current issue of the scientific journal Endocrinology, is authored by scientists from the University of Wisconsin, the University of Kansas Medical Center, and Curis, Inc. and is entitled "Hedgehog Signaling Promotes Prostate Xenograft Tumor Growth." These authors conclude that abnormal activation of the Hedgehog pathway in prostate cancer cells results in the synthesis of various factors that dramatically accelerate growth of the tumor in a preclinical model of prostate cancer.

Prostate cancer is the third most common cause of death from cancer in men of all ages and is the most common cause of death from cancer in men over 75 years old. The National Cancer Institute estimates that more than 189,000 men in the United States will contract prostate cancer this year.

In the second report, in the current issue of the International Journal of Cancer, scientists from the University of Heidelberg report that abnormal activation of the Hedgehog pathway contributes to pancreatic tumor growth. The authors also report that pancreatic tumor growth in a preclinical model can be inhibited by using a Hedgehog pathway antagonist. This report is entitled "Indian Hedgehog Signaling Pathway: Expression and Regulation in Pancreatic Cancer."

Pancreatic carcinoma is one of the deadliest forms of cancer, and there is currently no adequate therapy. According to the National Cancer Institute, of the approximate 30,000 new cases each year in the United States, 95% will die within five years.

The third report, also in the International Journal of Cancer, is authored by scientists from the University of Bristol and is entitled "Hedgehog Signaling in Colorectal Cells: Induction of Apoptosis with Cyclopamine Treatment." These authors report that abnormal signaling of the Hedgehog pathway in colorectal tumor cells promotes the survival of these cells and that treatment with a specific Hedgehog pathway inhibitor, cyclopamine, can selectively kill those tumor cells in a preclinical model.

According to the National Institutes of Health there are over 130,000 cases of colorectal cancer diagnosed in the United States each year and over 50,000 deaths. Colorectal cancer is the second leading cause of cancer deaths.

Daniel Passeri, Curis' President and Chief Executive Officer, said, "These three reports, two of which are by research groups unaffiliated with Curis or Curis' collaborators, though preliminary in nature, add to the body of preclinical evidence that supports the linkage between abnormal Hedgehog pathway signaling and cancer. We believe that methods of inhibiting the Hedgehog signaling pathway may constitute a promising new therapeutic approach to the treatment of these cancers."

About Curis, Inc.

Curis, Inc. is a therapeutic drug development company. The Company's technology focus is on regulatory pathways that control repair and regeneration. Curis' product development involves the use of proteins or small molecules to modulate these pathways. Curis has successfully used this technology and product development approach to produce several promising drug product candidates in the fields of kidney disease, neurological disorders, cancer, alopecia, and cardiovascular disease. For more information, please visit the Curis web site at www.curis.com.



To: Biomaven who wrote (11988)6/9/2004 12:27:42 PM
From: A.J. Mullen  Respond to of 52153
 
Varying effectiveness of EGF inhibitors in combination with chemotherapy:

Firstly Iressa hasn't been shown to extend life significantly in all NSLC patients when taken alone, so it's not that surprising that statistical significance isn't found in combination. Iressa was approved because it has a dramatic effect on 10% of patients.

Predictions can now be made as to who will benefit from EGF inhibitors (Iressa, Tarceva) based on EGFR mutations of their tumours. Non-smokers are more likely to benefit.

Tests for significance assume patients are selected at random, but inclusion of patents into trials is unlikely to be random. For a start they are based out of leading medical centers. Access to those centers is not random but biased geographically and socially. Some patients try very hard to get into trials; it's an initiative test where the perceived prize might be life versus death.

It would be very hard to work out the amount of selection that occurs in recruitment to trials, but it is likely to vary between researchers, medical centers, and countries. A good measure for selection might be the proportion of those who had never smoked - it's probably a proxy for education and socio-economic class.

Maybe Shepherd's study had more non or never-smokers? They seem much more likely to EGFR mutation and are more likely to respond to EGF inhibitors.

Ashley