Seeking Alpha: Forget Arena Vs. Vivus - Zafgen May Be The Ultimate Winner

As an investor and writer with no financial stake in any of the companies involved, watching the message board battles between Arena (ARNA) and Vivus (VVUS) shareholders is good theater. Both companies have FDA-approved drugs on the market that are effective in helping obese people lose weight, but neither Arena's Belviq nor Vivus's Qsymia look like "the one obesity drug to rule them all". Belviq is hampered by modest efficacy, while Qsymia can produce scary side effects and has a more limited marketing effort behind it.

Quite frankly, though, the Arena-versus-Vivus battle may ultimately be just the undercard for the real battle. A private biotech company by the name of Zafgen has drug in clinical testing that has shown very impressive efficacy and solid safety, and happens to work by a completely different mechanism than biotech and pharma companies have pursued so far. While Arena and Vivus likely have at least three years before Zafgen's drug becomes a clear and present danger, investors in those companies may want to consider the risk that their parties could be brought to a premature end if Zafgen can continue to produce such strong data.

Please continue to the full piece here:
Forget Arena Vs. Vivus - Zafgen May Be The Ultimate Winner

Investopedia: Weight Watchers Still Can't Get It Right

I generally try to consider both the positives and negatives of every stock I analyze, but that has gotten increasingly difficult with Weight Watchers (NYSE:WTW). I have long had my issues with this management team, and I believe management errors have finally started to take their toll on the valuation. While I do believe the brand carries considerable value and that this could be a highly attractive business if run properly, I have little confidence that this team can do it.

Continue reading here:
http://www.investopedia.com/stock-analysis/2013/Weight-Watchers-Still-Cant-Get-It-Right-WTW-NTRI-NSRGY-ARNA0215.aspx

Seeking Alpha: Can Anything Stop Novo Nordisk?

Novo Nordisk (NVO) is a company for the record books and MBA lesson plans. This Danish biopharmaceueticals company doesn't try to do very many things, but it does them very, very well. With modest near-term competitive risks and substantial potential value in the pipeline, operationally there is little to fear at Novo Nordisk. The question for investors, as is so often the case with this stock, is what is the proper price to pay for that excellence.

Please click here to continue:
Can Anything Stop Novo Nordisk?

Investopedia: Weight Watchers May Be the Best House On An Awful Street

Everybody knows that obesity is a huge problem in America, but it's devilishly hard to make money here on a sustained basis. The sales of various diet drugs and devices have largely disappointed their developers, and even those companies that have steered clear of the FDA process (supplements and "nutritional products") have struggled to make the money that investors expected. That puts Weight Watchers (NYSE:WTW) in a curious place - although Wall Street has gotten a lot more rational about this name (and the stock has badly underperformed this year as a result), it's still not necessarily a compelling stock today, even though it may be the best-positioned company in the market.

Please click below for more:
http://www.investopedia.com/stock-analysis/2012/Weight-Watchers-May-Be-The-Best-House-On-An-Awful-Street-WTW-NTRI-ARNA-VVUS1106.aspx

Seeking Alpha: Is Biotech Getting Too Frothy? Investor Sentiment Suggests Irrational Exuberance

Investors with many years of experience in biotech know there's something to the idea that the best time to prepare for war is during peace (and vice versa). With the biotech sector heading for its second straight year of strong returns, it's worth asking whether investors are getting a little too cavalier about risk and whether investors in the sector are getting set up for a sizable correction.

Please continue here:
Is Biotech Getting Too Frothy? Investor Sentiment Suggests Irrational Exuberance

Seeking Alpha: With Qsymia Approval, The Race Is Now On

As expected, Vivus (VVUS) got FDA approval for its anti-obesity drug Qsymia (formerly known as Qnexa) on Tuesday. With both Arena Pharmaceuticals (ARNA) and Vivus beating the odds and getting the FDA go-ahead, the race is now on to disprove the skeptics (and validate the bulls) and rack up significant prescriptions and drug sales. While I do believe Vivus has the edge in this race, investors should not underestimate the challenges of launching new drugs to skeptical docs.

Please read more here:
With Qsymia Approval, The Race Is Now On

Investopedia: The Week Ahead In Healthcare

For better or worse, late June through mid-July tends to be a period where very little of note happens. There are no major medical conferences during this period, the FDA seems to avoid scheduling PDUFA dates during this time period, and there are no significant earnings on the calendar. With analysts and managers using the time to take rare vacations (or not-so-rare excursions to the golf course), stocks tend to drift and investors can likely expect the same for the week ending July 13.

Please click here for more:
http://stocks.investopedia.com/stock-analysis/2012/The-Week-Ahead-In-Healthcare-VVUS-GSK-JNJ-XLV0706.aspx

Investopedia: Arena Pharmaceuticals - One Huge Step Forward, But Many More Remain

Patient (or long-suffering, depending upon your point of view) Arena Pharmaceuticals (Nasdaq:ARNA) shareholders got some major validation on June 27, 2012, when the company announced that the FDA had formally approved the company's weight-loss drug, Belviq (aka lorcaserin). With a commercial launch with marketing partner Eisai expected around the end of the year, investor attention now shifts to the questions of whether Belviq will prove popular with doctors and patients, whether it will get adequate reimbursement, and what the total market potential will ultimately be.

Read more here:
http://stocks.investopedia.com/stock-analysis/2012/Arena-Pharmaceuticals--One-Huge-Step-Forward-But-Many-More-Remain-ARNA-VVUS-OREX0628.aspx

Investopedia: Control May Be Herbalife's Real Long-Term Problem

Herbalife (NYSE:HLF) has gotten knocked around hard lately, as well-known investor David Einhorn has apparently taken some interest in the company and asked some fairly pointed questions. Although I don't agree with those who have interpreted his questions as implying that there is any sort of pyramid scheme at work, that doesn't mean that there aren't inherent issues with the Herbalife model. While there is likely to be sustained ongoing demand for the sort of supplements that Herbalife sells, I wonder whether Herbalife's model takes too much of the company's growth potential out of its own hands.

Please read more here:
http://stocks.investopedia.com/stock-analysis/2012/Control-May-Be-Herbalifes-Real-Long-Term-Problem-HLF-MED-VSI-ARNA-VVUS-AVP0604.aspx

Seekin Alpha: Novo Nordisk Finally Looks (Slightly) Mortal

To whom much valuation is given, much is expected. That's about the only sense in which Novo Nordisk (NVO) disappointed anybody this quarter. While this highly-focused pharmaceutical company has been enjoying phenomenal success in diabetes, investors may just want to check into the estimates that underpin the valuation before committing their capital to these shares.

Please follow this link for more:
Novo Nordisk Finally Looks (Slightly) Mortal

Investopedia: Nutrisystem Still Searching For Sustainability

One of the things that makes the health/lifestyle/fitness market tricky is that not only do companies have to fight to attract customers, they have to continue the fight to keep them. With customers constantly looking for weight loss options that are easy, effective and cheap, Nutrisystem (Nasdaq:NTRI) has had a difficult time finding a steady growth trajectory. (For more, see Earning Forecasts: A Primer.)


Promotions Drive a Tougher Comp 
Nutrisystem certainly closed the 2011 year on a down note. Revenue fell about 20%, due at least in part to promotional activity that wasn't as successful as hoped. Although management doesn't really provide clear retention or recruitment numbers in its conference call, it seemed pretty clear that both metrics were worse than what they had hoped.


Click here for more:
http://stocks.investopedia.com/stock-analysis/2012/Nutrisystem-Still-Searching-For-Sustainability-NTRI-WTW-MED-VVUS0312.aspx

Investopedia: Wall Street Isn't Buying The Medifast Story

Whenever an investor finds a stock that looks simply too cheap, it's wise to question why that may happen. Some stocks are simply under-followed and over-looked and represent real bargains. In other cases, investors have made mountains of molehills and overestimate the risks present (or underestimate the growth). Then there are cases where the Street may be right to be wary and cautious, and a seemingly cheap stock is, in fact, priced appropriately for the risks.

In that vein, it's worth taking a closer look at Medifast (NYSE:MED), as this growing weight loss play seems cheap, relative to historical financials.

Please continue here:
http://stocks.investopedia.com/stock-analysis/2012/Wall-Street-Isnt-Buying-The-Medifast-Story-MED-WTW-NTRI-HLF0305.aspx

Seeking Alpha: Vivus's Qnexa And Its Potential Value

Vivus's (VVUS) chances of getting FDA approval for Qnexa, its investigational drug combination for obesity, have never looked better. To suggest that the process has been difficult would be to say that War and Peace is a little wordy or that Michael Jordan could play a little ball.

Nevertheless, a surprisingly positive panel vote has investors excited that the FDA very well may approve the first prescription drug for obesity in over a decade. The question investors may want to ask then, aside from what the chances are that the FDA goes along with its panel, is how much appreciation potential may be left in the shares.

Please read the full piece here:
Vivus's Qnexa And Its Potential Value

Investopedia: More Yo-Yo'ing At Weight Watchers

Weight Watchers (NYSE:WTW) is one of those oddly volatile stocks. Although the company's inconsistent attendance history and highly levered balance sheet no doubt explain some of it, it is curious that this is a Wall Street plaything. With the company offering disappointing guidance on attendance, it looks like this earnings cycle is just feeding that volatility engine once again. (To know more about analyzing a business, read How To Evaluate A Company's Balance Sheet.)

Good Performance All Around  
Weight Watcher's third quarter was actually pretty strong in many respects. Revenue was up almost 30% as reported, and more than 26% on a constant currency basis. Paid weeks rose 38% and overall attendance was up 9%. North America was strong - revenue was up almost 25%, paid weeks were up almost 26% and attendance jumped more than 13% (though was up just about 5% on a rolling two-year basis). International was not so strong - revenue was up just 7% in constant currency and attendance growth barely surpassed 1%.

To read the full article, please follow this link:
http://stocks.investopedia.com/stock-analysis/2011/More-Yo-Yoing-At-Weight-Watchers-WTW-HLF-USNA-NUS-MED-NTRI-VVUS-NSRGY-MED-ARNA1109.aspx

Investopedia: Vivus Tries A New Path

If at first you don't succeed, keep trying until the money runs out. That would seem to be the underlying strategy at Vivus (Nasdaq:VVUS), as this biotech continues to try to find a successful path to FDA approval for its obesity drug Qnexa. With news that the FDA may be more amenable to a different label, investors may have some reason for cautious optimism that a new obesity drug could actually hit the market within the next 12-18 months.

If You Can't Beat 'em, Avoid 'em  
One of the issues that has held up FDA approval of Qnexa (a new combination of previously approved drugs phentermine and topiramate) is the known birth defect risks of topiramate and the possibility that this new combination drug could have similar (or perhaps even worse) risks of teratogenicity. What makes this issue more complicated, though, is the fact that much of the birth defect data on topiramate was generated from women who also had epilepsy - and epilepsy is a known risk factor for birth defects.


To read more, click below:
http://stocks.investopedia.com/stock-analysis/2011/Vivus-Tries-A-New-Path-VVUS-ARNA-OREX-PFE-LLY-GSK-WTW-NVS0920.aspx

Investopedia: Herbalife - Stealth Emerging Markets Play?

It doesn't matter how much doctors and nutritionists may decry supplements, they are popular and people want to believe in them. That has underpinned good growth in a sector with none of the patent worries of pharmaceuticals and minimal FDA interference. It has also led to solid stock market performance for traditional store-based retailers like Vitamin Shoppe (NYSE:VSI) and GNC (NYSE:GNC) as well as multi-level marketing firm Herbalife (NYSE:HLF). (For help on choosing stocks, check out How Investors Can Screen For Stock Ideas.)

Growth in a Bottle in Q2  
Herbalife continues to rack up impressive growth. Revenue rose 28% in the second quarter, with organic growth on the order of 20%. There are several metrics that investors can use to evaluate the underlying momentum of Herbalife's business and regional volume points is one of them. By this standard, volume rose more than 17% in the second quarter, with exceptionally strong growth in Asia-Pacific, Mexico, and Central/South America. Results in North America and Europe were more sedate (mid-single digit growth), while the China numbers were actually down about 9%. Overall reported revenue from China was flat, though. 


To read the full piece, please click below:
http://stocks.investopedia.com/stock-analysis/2011/Herbalife--Stealth-Emerging-Market-Play-HLF-VSI-GNC-USNA-WTW-NTRI-VVUS0805.aspx

Investopedia: Arena's New Data Doesn't Change Obesity Pill Outlook

It is understandable that long-suffering Arena Pharmaceuticals (Nasdaq:ARNA) would react very positively to an almost sign of good news. After all, this company's stock has taken a pounding in the wake of the FDA's rejection of the company's drug lorcaserin for obesity. While any positive news relating to efficacy certainly does not hurt the prospects for refiling the drug application and eventually gaining approval, Thursday's news does not solve Arena's biggest problems.


Is Meta-Analysis the Same as Data Mining?
On Thursday morning, Arena announced data from meta-analyses of three of the trials for lorcaserin. This data was presented at the European Congress on Obesity and indicated that almost half of patients taking two 10mg doses a day saw more than 5% weight loss, more than double the rate of response in the placebo group. More than one-fifth of those same patients saw better than 10% weight loss; nearly triple the response seen in the placebo group.

Unfortunately, most observers are going to regard this data with a shrug. Clauses like "Modified intent-to-treat with last observation carried forward" are tantamount to data mining in many people's eyes, and the FDA has been very aggressive in rejecting such analyses. This is not to say that lorcaserin doesn't work; rather it just seems unlikely that the FDA is going to revise its viewpoint that lorcaserin offers "marginal efficacy" on the basis of a new look at old data (as opposed to a new study showing better outcomes). 



To continue, follow the link:
http://stocks.investopedia.com/stock-analysis/2011/Arenas-New-Data-Doesnt-Change-Obesity-Pill-Outlook-ARNA-VVUS-OREX-DNDN-VNDA-HGSI0530.aspx

Investopedia: Can NutriSystem Find A Healthy Size?

With the FDA seemingly adamant about approving new weight loss drugs, it would seem to be better days for Weight Watchers (NYSE:WTW) and NutriSystem (Nasdaq:NTRI). Although it is anybody's guess as to how much competition would have come from Vivus (Nasdaq:VVUS), Arena (Nasdaq:ARNA) or Orexigen (Nasdaq:OREX) (or may still come, if these companies can appease the FDA), these two companies represent the only concentrated plays on weight loss and obesity. 

Unfortunately, dismal guidance from NutriSystem has this stock on the ropes for the time being.  

A Sour End to 2010  
The problems at NutriSystem start right at the top. The company reported that revenue fell 17% in the fourth quarter; analysts were expecting a down year-on-year comparison, but more on the order of 5%. Surprisingly, the company nevertheless posted solid improvements in gross margin, adjusted EBITDA, and operating profit - the latter of which clearly benefited from a lower marketing spend in the quarter.  

Please continue to the full piece:
http://stocks.investopedia.com/stock-analysis/2011/Can-NutriSystem-Find-A-Healthy-Size-NTRI-WTW-VVUS-K-ABT-KFT-CAG0228.aspx

FDA's Bizarro World - Orexigen Gets Panel Approval

Welcome to Bizarro World, courtesy of the FDA. At the beginning of 2010, there was a widespread belief that Vivus (Nasdaq:VVUS) would get approval for its obesity drug Qnexa and that Arena Pharmaceuticals' (Nasdaq:ARNA) lorcaserin had at least a fighting chance; Orexigen (Nasdaq:OREX) was the long-shot candidate with its drug Contrave. When FDA panels subsequently voted down both Qnexa and lorcaserin and the FDA followed up with complete response letters (rejections), most observers thought Contrave had little chance.

Late on Tuesday, the FDA's panel reviewing Contrave voted 11-8 to recommend approval. That is a huge win for Orexigen. It also looks to be a boon for Vivus and Arena as well, though, as it raises the possibility that these companies will eventually convince the FDA to grant approval.

Going Through the Details

Contrave is a combination drug that blends the long-approved drugs naltrexone (originally approved to treat addiction) and bupropion (depression) into a single sustained-release treatment. Contrave missed one of the FDA's efficacy benchmarks (an average of 5% weight loss), but surpassed the other (35% or more patients achieving 5% or better weight loss). In terms of safety, the trials have shown some risks relating to blood pressure, but far and away the worst side-effect was nausea (which has led as many as one-quarter of patients in trials to drop out). (For more, see Orexigen Finds A Cautious Partner.)

Please follow the link for the full piece:
http://stocks.investopedia.com/stock-analysis/2010/FDAs-Bizarro-World---Orexigen-Gets-Panel-Approval-OREX-ARNA-VVUS-ABT-DXCM1208.aspx

FDA Locked And Loaded For MELA Sciences

The FDA has been playing a rough game of "Whack-A-Mole" lately, smacking down would-be drugs in the fields of obesity, diabetes and psychiatry, and hitting the stocks of companies like VIVUS (Nasdaq:VVUS), Arena Pharmaceuticals (Nasdaq:ARNA) and Alexza (Nasdaq:ALXA). With a very aggressive pre-panel meeting review, investors are now extremely nervous that the agency is about to do the same to MELA Sciences (Nasdaq:MELA) and MelaFind, the company's would-be testing device for melanoma (a very serious type of skin cancer). 

A Consummate Binary Event
For investors who are not familiar with the term "binary event", the FDA's ultimate decision on MelaFind is a very good working definition. While large medical device companies like Stryker (NYSE:SYK) or Medtronic (NYSE:MDT) need FDA cooperation to thrive, it is more of a matter of survival for MELA Sciences.

If the agency grants approval, the company will be able to enter a large field with no other comparable competitive device option. If the agency refuses to allow MELA to market this device, the company has nothing else in its bag and will effectively be a zombie company. In other words, the stock will go up a lot if the FDA approves MelaFind, or down a lot if MelaFind is rejected. Not surprisingly, then, there has been a huge amount of stock shorting interest and option activity going into Thursday's panel meeting.

To read the full piece, please go to:
http://stocks.investopedia.com/stock-analysis/2010/FDA-Locked-And-Loaded-For-MELA-Sciences-MELA-VVUS-ARNA-ALXA-MDT-SYK1116.aspx