(By Rich Bieglmeier) Americans are fat and getting fatter – are we still allowed to say fat?
According to the Center for Disease Control (CDC), 35.7% of US adults and almost 17% of youth are obese. A study of the 27 European Union countries by the European Commission suggests that as many as 50% of Europeans are overweight to obese. The CDC defines obese as people with a body mass index (BMI) equal to or greater than 30%.
As you probably are aware, a new study suggests that 42% of Americans could be obese by 2030.
The latest statistics we could find - without spending $3,400 on an industry report - showed that Americans spent more than $60 billion on weight loss products in 2011. That's up from $40 billion in just four years. Additionally, the CDC says obesity costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity.
iStock doesn't need to tell you that an FDA OK for drugs that help people lose weight has the potential to unleash blockbusters.
The timeline is drawing near for new entrants in this rapidly expanding market. Within five weeks, two small-cap biotechs have the potential to do something that hasn't been done in 13 unlucky years, get FDA approval for a drug that treats obesity.
The race for first to market is on between VIVUS Inc. (VVUS) and Arena Pharmaceuticals, Inc. (ARNA). Both companies are speeding around turn three and can see the checkered flag waving on the horizon.
All ARNA has to do is keep it off the wall, and investors could celebrate in the winner's circle with a Champagne shower on or about June 27, 2012. Last Friday, The FDA's Drugs Advisory Committee voted 18-4 fort Arena's Lorcaserin to receive approval.
The board noted, "the potential benefits of Lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals."
On the news, Jefferies Group put the odds of approval at 95% and placed a price target of $9 on ARNA shares. However, the drug was already rejected in 2010 due to concerns about heart-valve disease and cancer. So, risks do remain.
If Arena Pharmaceuticals blows a tire by June 27th, investors won't have to wait too long for VVUS to barrel down the final straightaway. Vivus also received a board recommendation for approval for its obesity drug QNEXA. However, the final decision was delayed from mid-April until July 17th.
While iStock can't say for sure either drug will be okayed, we believe the odds are high that one or both will be approved. Now, let's do the math just in case.
The US population is estimated to be 313 million, of which roughly 75 are adults. That translates to approximately 235 million people who are at least 18-years old. Using the latest obesity figures of 35.7%, we come up with 83 million potential Lorcaserin or QNEXA users.
From what we have read, both drugs are expected to be priced between $1 and $2 a day. For our iEstimate, we will use the low end of $1. For every one percent of prescription penetration, that's 830,000 people paying $365 a year, equaling $302 in annual revenues. If we use a net profit of 24%, the bottom line could come close to $72 million per 1% usage.
In the first year, iStock can envision 3% penetration, with total revenue above $900 million and profits of at least $210 million. Let's say the new market is split 50/50 between VVUS and ARNA.
Arena Pharmaceuticals has 182.5 million shares out, and their share of the profits equates to $105 million, for a hypothetical 58 cents per share in earnings. Toss the industry average P/E of 16.6 on it and, in our estimation, ARNA's stock is worth at least $9.68 on approval.
Using the same math for Vivus, with its 99.7 shares outstanding, approval could add more than $1 to earnings. Using the same industry P/E of 16.6, and investors could see VVUS jump as much as $16.70 with a FDA OK.