July 3, 2012 Arena Pharmaceuticals (ARNA) saw a jump of
nearly 30 % in its stock price on the news that the Food and Drug
Administration had approved its much-awaited obesity drug, lorcaserin, which
Arena has branded Belviq. This is the first anti-obesity drug that the FDA has
approved in almost 13 years, as many efforts in this direction by major
pharmaceutical companies have been affected by side effects and issues
concerning safety. The company CEO said that he believed that this represents a
turning point for physicians in the treatment of overweight and obese patients.
It is also a landmark for the company which has managed to survive for 15 years
without launching a single new product in the market. The company was
established in 1997 for the creation of drugs targeting G-protein coupled
receptors, and it also has other drugs in development for treating pain,
diabetes and other medical conditions. Obesity treatment is the jackpot for
Arena. Obesity has become a major global
problem, prompting the CDC in Atlanta
to call for it to be classified as a major disease. The Journal of the American
Medical Association estimates that nearly 36% of adult Americans can be
classified as medically obese, and the numbers are increasing. Obesity is
becoming a major issue in Europe and many
other parts of the world. This means that lorcaserin has every possibility of
becoming a major blockbuster drug. Edward Tenthoff, an equity analyst with
Piper Jaffray, has calculated that even a penetration of just over 1% could
mean almost $2 billion in sales in the United States . All this money will
not find its way into the pockets of Arena because of its partnership agreement
with Japanese drug maker Eisai, who will take charge of marketing and share a
large portion of the revenues. However, if everything works out according to
the plan, Arena would be entitled to receive milestone payments that could
amount to as much as $1.2 billion. Arena
had previous problems with the drug when the FDA rejected the initial
application in 2010, but it would seem that the additional data supplied by the
company has shown less risk than was previously thought. Estimates show that the
US
weight loss market is worth more than $60 billion and that the market for OTC
diet pills and medication is expected to grow at more than 3% annually. This
puts Arena in the position of being a company with a multibillion-dollar market
cap if they are able to capitalize on the potential of the drug properly. And
you should bear in mind that this is a market where Arena will have few
competitors and where there is a high barrier to the entry for new medications. We must not forget that Arena has had competitors
hot on its heels who could win FDA approval in the near-term future. Both Vivus
(VVUS) and Orexigen Therapeutics (OREX) have spent the last few years
developing their diet pills needed to stem the epidemic of obesity in America .
Vivus' diet pill, Qnexa, was backed by an FDA advisory panel in February, but
the FDA has asked for more data and has delayed the approval until mid July.
Orexigen is way behind in the approval process, but the company believes that
it will be able to compete effectively even if it is beaten to market by Arena
and Vivus.The FDA has moved cautiously in the approval of new weight-loss drugs
after the withdrawal of previously approved drugs. Abbott Laboratories (ABT)
withdrew diet pill Meridia in 2010 from the market because of mounting concerns
about the possibility of heart attack and strokes. The diet-drug combination
fen phen was taken off the market in 1997 by American Home Products, now a part
of Pfizer (PFE), because of the risk of damage to heart valves. When you have events with a known date such
as an FDA drug approval, the price and volatility of the stock spike as
investors take bets on the chances of approval. This can often lead to
overvaluation of the stock concerned. Movements can often be 50% in either
direction with a large downside if approval is held up for any reason. You only
have to look at examples like Amylin Pharmaceuticals (AMLN), which lost half of
its value when the FDA did not approve Bydureon as a potential diabetes drug
and asked for more testing. Similarly, the FDA rejected the GTx (GTXI)
experimental drug to reduce fractures in men with prostate cancer asking for
another study to be conducted. The stock subsequently took a beating. There has
been plenty of action for Arena stock in anticipation of the FDA approval. What happens next? When biotechnology
companies see a sharp rally in the price following the receipt of an FDA
approval, the next step is to make a secondary offering in the market to raise
capital on favorable terms. Under the terms of its agreement with Eisai, Arena
is required to manufacture and supply the drug from its facility in Switzerland for marketing and distribution in
the United States .
I think it is logical for Arena to raise more equity. It currently has about
$90 million in cash and the same in debt, with total equity of about $45
million. It remains to be seen whether this cash will suffice for its
requirements in the immediate future. With
this background, Arena is obviously a desirable stock for investment, and the
question is whether it is a good buy now. I do not believe in timing the market
and an investment must justify itself on the basis of fundamentals alone. Arena
may be slightly overvalued at the moment, but I would still recommend buying
this stock. While its competitors are on its heels and the potential of the
anti-obesity drug treatment market yet to establish itself, I think now is the
best time to get in. Disclosure: I have
no positions in any stocks mentioned, and no plans to initiate any positions
within the next 72 hours.
Source: http://seekingalpha.com/article/698721-obesity-drug-may-be-goldmine-for-arena?source=feed
No comments:
Post a Comment