RE: PhilippaRBC Dominion Securities Inc.
Philippa Flint (Analyst)(416) 842-7854; philippa.flint@rbccm.com
Underperform
UnderperformSpeculative Risk
Price Target: 8.50
No defined regulatory pathway. A key concern we have is that the FDA hasnot approved any product for GH-deficient abdominally obese patients, and to
date TH has not had any discussions on appropriate endpoints. Therefore, there
is considerable regulatory risk ahead. We assume discussions would take place
between TH and FDA prior to embarking on a long and expensive pivotal trial
program.
No defined regulatory pathway• Market potential too vague to quantify. In our view, although one couldjustify the market potential by estimating the percent of patients who suffer
from this condition and conservatively assuming a low market penetration,
these types of calculations are meaningless if the product never reaches the
market. Management suggested the market could be $0.9 to $1.8 billion in the
U.S. At this point in time, we assign no value to this indication as it is too early
in development, there is no identifiable regulatory approval pathway, and we
would expect reimbursement to be negligible.
• No material news. No comments on strategic review. Management did notdisclose any information on the ongoing strategic review. In our view, today's
news is a simple investigator-sponsored study that is not material to the
company's outlook.
Priced