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Orexigen CEO Upbeat Despite Street's Indifference
Investor's Business Daily
By Peter Benesh
February 22, 2008
Even with promising data, institutional interest and a huge potential
market, a young biopharma company can have trouble getting traction
for its stock.
Orexigen Therapeutics OREX finds itself in that situation. The
company reformulates and combines long-known, generic drugs into
new compounds -- Contrave and Empatic -- that fight obesity.
After its April initial public offering at 12, Orexigen shares
had moved above 19 less than a month later. Shares bounced around
over the next four months, approached the high in mid-October and
have since trended down.
Needing more capital, Orexigen went to the market in January and
sold 7.3 million shares. The best it could get was $11.
The good news: Institutional investors and banks snapped up all
they could. They see the potential in the company, says Orexigen
Chief Executive Gary Tollefson.
The problem is not the company, he says -- it's the market. He
spoke with IBD.
IBD: What's the silver lining in your acceptance of $11 a share?
Tollefson: Considering the market we went into, we're pleased
to get the deal done and to get the quality of the investors we
did. They're good, long-term holders of the stock, well-known institutional
names. The biggest holders are Fidelity and Oppenheimer.
I took it as a vote of confidence in the future of the company.
IBD: What has the company done to build value since its IPO?
Tollefson: We've reduced risk in a number of aspects and we've
made substantial progress with our development program.
We were able to give one-year data on both Contrave and Empatic,
our two later-stage obesity products. These were phase two results
that corroborated not only a desirable amount of weight loss, but
also that the trajectory of that weight loss continued out through
one year.
We were successful in mitigating the effect of the weight-loss
plateau which is typically seen with drugs and diet, where at 16
to 24 weeks you stop losing weight.
We saw a downward trajectory after one year, which is consistent
with the mechanism of action of both Contrave and Empatic.
We started phase three trials for Contrave. And (on Jan. 31) we
received a significant ruling by the U.S. Patent and Trademark
Office, which extended the protection of our composition of matter
for Contrave out an additional 11 years to 2024. That's a major
intellectual property advance.
(Orexigen shares fell 3.5% that day and rose 4% the next day).
IBD: One might think that alone would send the stock up.
Tollefson: We would have anticipated more benefit to the stock
price. We talked to investors and asked the same question. We can't
come up with an answer.
We think that for all the milestones we've hit in nine months,
as well as starting the phase three Contrave program, that we haven't
seen the marketplace reward.
IBD: Why did you choose January to go to the market?
Tollefson: We had indicated at the time of the IPO that we'd be
back in the first half of 2008 for a follow-on.
IBD: So that was always overhanging the stock.
Tollefson: That overhang has been a factor.
We chose to go out when we did to take advantage of new data on
Empatic that we presented at the JPMorgan health care conference
in early January. We thought that would be a good launching pad.
We made these decisions to file with the Securities and Exchange
Commission back in December, when the markets were looking a lot
more positive.
We thought getting out early in the year was better than waiting
and not knowing what factors we'd see later.
So it was a combination of having new data, being able to launch
at the JPMorgan conference, and we thought we'd avoid some of the
risk of not knowing where the market would be later.
All that said, we needed to have that financing to get us through
four phase-three Contrave trials.
IBD: Why do four phase-three trials?
Tollefson: The Food and Drug Administration requires a certain
number of patient exposures through one year. We need to show 1,500
drug exposures and 700 placebo exposures.
We could do it in one megastudy but chose four smaller studies
to strengthen the commercial launch of the product in late 2010
or 2011.
Those studies target the key populations to whom we want to market.
One study investigates Contrave -- plus an aggressive diet and
exercise program -- to look at the drug's benefit with behavior
modification.
Another is with obese type-2 diabetics, to examine the benefits
on glycemic indices.
We're blending market research and customer interest and integrating
that with our outcome data. It's important to understand customers'
needs and to integrate that into clinical trials.
IBD: What do you see as the market potential for Contrave and
Empatic?
Tollefson: We haven't made our projections public. Americans spend
over $50 billion out of pocket for weight-loss strategies. We plan
to go the prescription route. This is such a huge market that anybody
can do simple math and come up with staggering numbers.
It's obvious a product in this space should be very successful.

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