Analyst Conference Summary

conference date: July 26, 2007
for quarter ending: June 30, 2007 (2nd quarter)

Forward-looking statements

Overview: Mainly still waiting for FDA approval of Zingo. Getting manufacturing and marketing in place. Possible partnership deals for sales if approved.

Basic data:

No revenues.

Net loss $13.8 million or $0.51 per share.

$62.8 million cash, a burn of about $9 million.

Guidance:

Unchanged 2007 guidance to net loss of $55 and $60 millon excluding non-cash stock compensation.

Conference Highlights:

Waiting for approval of Zingo for children. Fidufa date is September 24. Marketing and manufacturing in place. Seeking partner for broader marketing.

Phase III for Zingo for adults; could file supplemental NDA by end of year.

Adlea results have been rolling in. More trials on way, including Phase II studies with enrollments beginning in late summer or fall.  FDA is requiring safety database of only 1000 patients. Phase III studies being discussed with FDA.

Operating expenses $14.7 million, including $2.4 million non-cash stock compensation.

Net loss $13.8 million or $0.51 per share.

$62.8 million cash, a burn of about $9 million.

Q&A:

Zingo timing for launch if FDA approval? Pleased with progress with FDA, but want to have more guidance from them before setting a launch date.

Partnerships? Zingo looking for partners ex-U.S. In US wants to reach 1,200 hospitals our internal sales force can’t reach. Adlea potential partners are doing due diligence. Especially looking for an osteoarthritis partner.

Adlea Phase III knee start? Still hoping to get started by year end.

Why Adlea Phase II size increased? To give more statistical powering. Hip bump up is because pain levels are lower, so again about statistical significance.

FDA 1000 patients for Adlea? Based on whether it is a chronic drug. Adlea for OA of the knee is for 8 weeks with low systemic exposure, so is not a chronic drug. So you don’t need a carcinogicity study.

Hiring of sales force? Getting real close. Will hire managers first.

Re-explained specific Phase II/III Adlea trials.

Another company is experimenting with capsaicin for skin patches and they are getting similar results for time reduction of pain.

Off label use for Zingo? Yes, getting feedback that may happen.

Problems with Zingo per FDA? Clinical module tricky or bad questions. Starting to get CNC (manufacturing ) module questions, they are not troublesome. Completed audits of clinical sites, believe are done. Started plant inspections. Indicate FIDUFA date can be met.

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