conference date: May 8, 2008 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2008 (1st quarter)
Overview: Zingo to launch in late June, 2008.
Net loss $21.6 million.
Sales agreement in place for most of Europe and Middle East, but the regulatory approval process has not begun outside the U.S. Regulatory filing could be done by end of 2008 for Canada.
Zingo launch plan is for late June in pediatric hospital market. Sales force began marketing in February. Response has been enthusiastic, in line with surveys. Focus on pediatric radiology departments because of cost/benefit ratio. Analysis showed replacing cream-based analgesia would save enough time to increase number of patients treated daily. National media rollouts planned for launch. Wholesale acquisition cost will be $20, but high volume users will get a discount.
Had packaging issues, but they have been resolved. Inventory is being built and should be sufficient for launch.
Adlea for knee replacement and bunionectomy in Phase III. Intent is to get broad label for orthopedic surgeries. Data expected by end of 2008.
Operating expenses were $13.4 million for research and development, $8.5 million for general and administrative, total $21.8 million. ($1.6 million was non-cash stock-based compensation) Interest income was $0.25 million.
Cash remaining end of quarter was $70.0 million. Believes cash will cover expenses for 2008.
Zingo inventory and manufacturing? Everything is ready. We won’t give an inventory number.
Contract negotiations with pharmacists? Finalizing contracts internally; going out to GPOs and wholesalers soon, and won’t take too long.
Osteoarthritis trials? Since we decided to concentrate on surgery trials, we don’t have timeline for osteo. But we are confident we will do osteoarthritis.
Discount rate model? Too many variables to say yet, need to negotiate. But on next call this should be clearer.
First quarter of sales? We don’t know how much customers will stock, or if there will be returns. So it may take some time to get reliable numbers.
FIDUFA date for adult Zingo? January 9 or 10. Some informal feedback is they may get back to us sooner.
How fast can you launch after approval? We’ll be ready to promote it actively as soon as we get the approval.
Milestones for International sales? Royalties are in double digits. Skewed more to long-term than to up front payments. Our partners did their own market research and are similar to U.S. on a population basis. Data is ready for them to submit to their authorities.
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