GS NOTE: Amylin Pharmaceuticals, Inc. EPS (FY Dec) 2003E ($1.58), 2004E ($0.58) Outperform/Neutral
(AMLN) $25.96
Amylin reported top line data from its 2nd phase III trial with exenatide, in
development with Eli Lilly. Results appear consistent with top line data from the 1st
Phase III study: there was a statistically significant, dose dependent reduction in
blood sugar (HbA1c), weight reduction, and no major adverse events, including
severe hypoglycemia. Not unexpectedly, there was an increase in mild to moderate
hypoglycemia in patients on both sulfonylureas and exenatide, which we believe will
likely be manageable. While we were hoping to see more detail on HbA1c reduction,
we regard the consistency of the data as a positive. We expect that the stock could be
volatile given lack of some details of the results, and as the results from the final
Phase III study are expected later this quarter. We maintain our Outperform rating
and Neutral coverage view. Key risks include potential for negative clinical trial data
and or regulatory failures or delays on Symlin, which we think could be approved in
the U.S. around mid-December. |
