Every time the FDA turns around, a few more people have died from the diabetes drug Byetta, a product developed and marketed by Eli Lilly (NYSE: LLY) and Amylin Pharmaceuticals (NASDAQ: AMLN). It has to make one wonder how the regulators spend their spare time.
According toThe Wall Street Journal,the two companies "disclosed the deaths of four patients taking the diabetes drug Byetta that had been previously reported to regulators but not yet made public." The drug has already killed two people previously, at least.
Lilly and Amylin said they were a bit slow coming forward with the news because they wanted to "provide context" and "avoid confusion" in the future. That is double talk for the two companies not wanting to say anything at all. Dead is dead and there is no way of getting around that.
Why the FDA has allowed the drug to stay on the market is anyone's guess.
Douglas A. McIntyre is an editor at 247wallst.com.
When should the FDA pull a drug off the market? When one person dies from side-effects? How about two or three?
Eli Lilly (NYSE: LLY) and Amylin Pharmaceuticals (NASDAQ: AMLN) produce a highly successful diabetes drug called Byetta. According toThe Wall Street Journal, "The Food and Drug Administration on Monday said it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta."
Two of the patients died.
The drug makers said that the poor results were very rare. The people who got sick probably view it a little differently.
There have been questions for some time about whether the FDA does an effective job of regulating drug companies. The problems with Byetta say that the answer is "no." A drug, which causes even one death, yet stays on the market speaks volumes about how the consumer's interests are cast aside.
Douglas A. McIntyre is an editor at 247wallst.com.
"You can invest for all the right reasons and still get the wrong result," notes long-standing turnaround stock expert George Putnam, referring to the poor performance of the pharmaceutical sector in recent years.
Here, in his industry-leading The Turnaround Letter, he offers a fascinating review of 10 leading drug stocks which he now believes offer a combination of growth potential at "pretty cheap" valuations. Here is his overview.
"In 2000 and 2001, when the Internet boom was becoming a bust, many smart investors turned away from technology stocks and put their money into drug stocks. How could you go wrong with the big pharmaceutical companies?
"Demand for their products was growing as the population aged. These companies had huge research and development programs that seemed to keep cranking out new blockbuster drugs. And most of them had great balance sheets, with many paying handsome dividends.
"Much of this reasoning has been borne out in the intervening years. Many large drug manufacturers have rung up substantial revenue gains over the last decade. So what's happened to the big drug stocks? With few exceptions they have gone sideways or down – in some cases down a lot.
Net income more than doubled to $1.06 billion, or 97 cents a share, as sales of Cialis and Cymbalta climbed. Revenue rose 14% to $4.81 billion from $4.23 billion. Excluding one-time items profit was 92 cents, below the 96-average estimate of analysts surveyed by Thomson Financial. Revenue was expected at $4.83 billion. Thanks to a lower tax rate, company raised its 2008 forecast to $3.90 to $4.05, from $3.73 to $3.90.
"Following strong performance in 2007, Lilly continued to deliver solid financial results in the first quarter of 2008," commented John Lechleiter, the company's new chief executive officer, said in the earnings release. "Double-digit sales growth was once again primarily driven by volume. ...We also made appropriate investments in R&D to accelerate the progress of our mid-stage pipeline, resulting in six molecules advancing to the next stage on clinical development this past quarter, while at the same time delivering strong earnings per share growth for the quarter."
The earnings miss was due to a larger-than-expected charge for halting development of the AIR insulin inhaler. The $145.7 million, or 9 cents a share, was at least $25.7 million more than the Indianapolis-based company estimated when it abandoned the drug last month, according to Bloomberg.
Miller Tabak analyst Les Funleyder told the news service that "In the near term, our earnings picture isn't that bad for Lilly, but they have a Zyprexa problem. It is going off patent soon and Risperdal is going off patent in the second half of this year.''
Shares of Lilly fell $2.29, or 4.4%, to $49.78 in early trading.
This year, the International Trade Commission is set to issue rulings on whether Samsung and Nokia Corporation (NYSE: NOK) have infringed patents from InterDigital Inc (NASDAQ: IDCC). If InterDigital, who licenses its patents to iPhone maker Apple Inc (NASDAQ: AAPL), wins, fees from the deals could double its revenue over the next few years, the Wall Street Journal contended.
According to FDA commissioners, the New York Times reported that Baxter International Inc's (NYSE: BAX) critical blood thinner heparin, which has been linked to nearly 20 deaths and whose base was created in China, contained a "possibly counterfeit" ingredient that "mimicked the real drug."
In his opening arguments in the state of Alaska's lawsuit against Eli Lilly & Company (NYSE: LLY), an attorney for the state alleged the drug maker failed to warn doctors and patients of dangerous side effects associated with its drug Zyprexa, the Associated Press reported.
Eli Lilly & Co. (NYSE: LLY) shares are rising this morning after the company reported a fourth-quarter profit of $854.4 million, or 78 cents per share. Adjusted earnings came out to 90 cents per share on revenue of $5.19 billion, beating analyst estimates of of 89 cents per share on revenue of $4.81 billion. If you think that the company won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on LLY.
After hitting a one-year high of $61.00 in April, the stock hit a one-year low of $49.09 in November. LLY opened this morning at $52.92. So far today the stock has hit a low of $52.02 and a high of $52.92. As of 12:00, LLY is trading at $52.45, up $1.05 (2.0%). The chart for LLY looks bullish but deteriorating, while S&P gives the stock a neutral 3 STARS (out of 5) hold rating.
For a bullish hedged play on this stock, I would consider an April bull-put credit spread below the $45 range. A bull-put credit spread is an options position that combines the purchase and sale of put options to hedge risk in case the stock doesn't do what you think but still leverage nice returns. For this particular trade, we will make a 6.4% return in just three months as long as LLY is above $45 at April expiration. Lilly would have to fall by more than 14% before we would start to lose money.
Bristol-Myers Squibb (NYSE: BMY)'s blood thinner Plavix is the second-largest selling drug in the world. It brought in over $3.4 billion in sales during the first nine months of this year. Eli Lilly (NYSE: LLY), however, believes it has a better treatment [subscription required]. According to The Wall Street Journal, its "new drug, known as prasugrel, is intended to treat patients on the verge of a heart attack." The new treatment can stop the build-up of platelets in the blood within thirty minutes
Lilly has a number of drugs going "off patent" in the next seven years. If these are not replaced, 50% of the company's revenue is at risk. It is not clear how long it will take the FDA to approve the drug, if it ever will.
The Journal writes that "in the head-to-head study, 9.9% of patients on prasugrel suffered either a heart attack, stroke or death from a cardiovascular cause, compared with 12.1% of those given Plavix. That is a 19% reduction in risk favoring prasugrel."
With new drugs, though, there is always a catch. Prasugrel is 32% more likely than Plavix to cause major bleeding.
Now the politics of drug approval will kick in. Experts for Bristol-Myers will say the new treatment is too dangerous and that Plavix is as close to perfect as a blood thinner can be. Lilly will claim that it can adjust the dose to cut down on bleeding and will get a legion of doctors to attest to that.
In the end, the patient can bleed to death or have a heart attack. Does it matter how he died?
Douglas A. McIntyre is an editor at 247wallst.com.
Over the years, Phase Forward (NASDAQ: PFWD)'s sophisticated software has managed more than 10,000 clinical trials with companies like Merck and Co. (NYSE: MRK), GlaxoSmithKline (NYSE: GSK), and Eli Lilly (NYSE: LLY). And investors are taking notice, as the stock price is up about 50% this year.
In Q3, Phase Forward reported a 24% increase in revenues to $34.9 million and net income was $5.7 million, or 13 cents per share, up from $2.9 million or 8 cents per share in the same period a year ago. The company's cash balance increased by $7.6 million to $187 million.
Phase Forward scored several key customer wins in Q3, such as with Novartis (NYSE: NVS) and Eisai, which is one of the largest pharma companies in Japan. No doubt, it helps that the company's software platform is highly scalable for complex, global organizations. This is critical in combating rivals like Oracle Corp. (NASDAQ: ORCL), ArisGlobal, and etrials Worldwide (NASDAQ: ETWC).
MOST NOTEWORTHY: Trident Microsystems, Comcast, Level 3 Communications, Ambac Financial and MBIA Inc were today's noteworthy downgrades:
Jefferies downgraded shares of Trident Microsystems Inc (NASDAQ: TRID) to Hold from Buy and lowered their target to $9 from $20 following the company's mixed quarter as they expect TRID to lose share in the TV market and face increasing price pressure. Shares were also downgraded to Hold from Buy at Deutsche Bank. Oppenheimer lowered Trident to Neutral from Buy, citing disappointing December guidance, delay in TV ramp, and expectations that 2008 will be a peak year for TV chip ramp revenues.
CIBC downgraded shares of Comcast Corporation (NASDAQ: CMCSA) to Sector Performer from Outperformer following the weak Q3 results to reflect increasing competition in telco video, slower broadband growth and the weakening economy.
JP Morgan downgraded Level 3 Communications Inc (NASDAQ: LVLT) to Neutral from Outperform following disappointing Q3 results and guidance.
Friedman Billings downgraded shares of Ambac Financial Group Inc (NYSE: ABK) and MBIA Inc (NYSE: MBI) to Market Perform from Outperform citing lack of near-term catalysts and uncertainty surrounding the credit markets.
MOST NOTEWORTHY: Air France, Eli Lilly, Merrill Lynch, Wal-Mart and GlaxoSmithKline were today's noteworthy downgrades:
Goldman removed shares of Air France (NYSE: AKH) from its Conviction Buy List due to the increase in the price of fuel and the possibility of an economic slowdown.
The firm also removed Eli Lilly (NYSE: LLY) from the list after the company suspended two studies of its anti-clotting drug. The company was also downgraded to Equal Weight from Overweight at Morgan Stanley.
UBS downgraded shares of Merrill Lynch (NYSE: MER) to Neutral from Buy as it believes the company's exposure to problem asset classes will remain under pressure and possibly lead to further write-downs. UBS lowered its Q4 estimate to $1.12 from $1.18 and 2008 estimate to $7.00 from $7.85. Shares were also downgraded at Wachovia to Market Perform from Outperform. The firm sees increased risk to the MER story given expected pressure on compensation to keep people, speculation around turnover in senior ranks, and the ability to retain and motivate people. Additionally, the firm sees further risk to MER's exposure to ABS, CDOs and sub-prime asset declines.
Rochdale downgraded shares of Wal-Mart Stores (NYSE: WMT) to Hold from Buy citing lack of catalysts from the company's two-day analyst meeting.
WestLB downgraded shares of GlaxoSmithKline (NYSE: GSK) to Sell from Add to reflect the company's growth prospects in Q4 and 2008.
Walter S. Mossberg, who writes the Wall Street Journal's "Personal Technology" column, reviewed Apple's (NASDAQ: AAPL) new Leopard operating system, and said it was "better and faster than [Windows] Vista".
Eli Lilly (NYSE: LLY) is halting two small studies of the most promising drug in its pipeline, prasugrel, which it hopes will bring over $1B a year in sales for the drug maker, reported the Wall Street Journal (subscription required).
The Wall Street Journal reported that Microsoft Corporation (NASDAQ: MSFT) has beaten Google (NASDAQ: GOOG) in a closely watched contest, winning a minority stake in Facebook for $240M, and the right to sell advertising on the Facebook site outside the U.S..
JPMorgan Chase (NYSE: JPM) is considering acquiring a stake in a Chinese brokerage as part of its expansion strategy in the country, said Gaby Abdelnour, chairman and CEO of JPMorgan Asia Pacific, reported the Financial Times (subscription required).
The Financial Times reported that Nintendo (OTC: NTDOY) raised its earnings outlook and announced that its 1H07 profits had tripled, thanks to the success of its Wii video game console and the DS, its handheld games player.
CIBC resumed coverage of Rigel Pharmaceuticals Inc (NASDAQ: RIGL) with a Sector Outperformer rating and $16 target. The firm expects near-term upside to be driven by positive phase 2 results of R788 in rheumatoid arthritis, expected in December, and thinks the company's strong scientific platform will support long-term appreciation.
Bear Stearns started Brightpoint Incorporated (NASDAQ: CELL) with an Outperform rating and $20 target, as they are positive on Brightpoint's merger with Dangaard given the significant synergies and diversification it provides.
"Biotechs are the ultimate recession-proof market segment," says Michael Shulman, who recommends Alkermes (NASDAQ: ALKS).
The editor of The ChangeWave Biotech Investor explains, "As investors flee companies that will be hurt by a credit crunch, money has flowed into many biotechsFears of an economic softening are pushing investors to recession-proof companies that can grow despite the economy."
Further, he contends, many biotech companies are cheap. He says, "They are at technical as well as fundamental bottoms, and sitting on large cash balances."
The bottom line, he notes: "Start considering bottom-fishing, right now. Go with growth, and companies with cash, and a good chart." One stock that he believes is "getting ready for an interesting few months" is Alkermes, the drug-delivery company.
Speculation intensified that the Federal Reserve is going to cut interest rates shortly, and moreover, some are suggesting that it already has cut them stealthily, reported the Wall Street Journal (subscription required).
The CEO of Deutsche Telekom (NYSE: DT) , René Obermann, called for the European mobile phone networks to be consolidated, reported the Independent.
Citigroup Incorporated (NYSE: C) is believed to be negotiating the purchase of a European pension plan worth about GBP200M, reported the U.K. Times.
U.S. Treasury Secretary Henry Paulson said the economy and markets are "resilient," and can absorb any losses from the recent market instability, and has not raised the possibility of policy changes to deal with the markets' problems, reported the New York Times.
Eli Lilly (NYSE: LLY), a company that makes money by treating depression, raised the spirits of Wall Street today, Eli Lilly exceeded analyst expectations for second quarter earnings and raised its projections for the rest of the year.
After backing out the acquisition cost of Hypnion Inc. and Ivy Animal Health, adjusted earning hit $0.90 per share, compared to expectations in the $0.80-0.82 range. The company also raised its 2007 year-end projection for adjusted earnings to $3.40-3.50, slightly above analyst expectations.
Strong quarterly earnings were attributed in part to the sales of anti-depressant drug Cymbalta, up 67% to over $500 million, Zyprexa, up 9% to $1.2 billion, and Cialis, that is still swelling worldwide. Recently announced results of studies that found little or no relationship between the SSRI class of antidepressants and birth defects have also strengthened the company's outlook.
However, many of the reservations Bloggingstocks' Victoria Erhart expressed a few months ago still remain valid, and the long-term health of the pharmaceutical company may be dependent on restocking a less than burgeoning drug pipeline.
The stock took a jump on news of the earnings report, up over $1, or more than 2%, in midday trading.
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Before the bell: Further declines; MER downgraded, SNDK may be bought, BA, DELL, MO ...
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