Amylin Pharmaceuticals CEO Discusses Q3 2010 Results - Earnings Call Transcript
Amylin Pharmaceuticals, Inc. (
)
Q3 2010 Earnings Call Transcript
November 4, 2010 5:00 pm ET
Executives
Michael York – IR
Dan Bradbury – President and CEO
Mark Foletta – SVP, Finance and CFO
Vince Mihalik – SVP, Sales & Marketing and CCO
Analysts
Robyn Karnauskas – Deutsche Bank
Jim Birchenough – Barclays Capital
Mark Schoenebaum – ISI Group
Yaron Werber – Citi
Thomas Wei – Jefferies
Steve Byrne – Bank of America
Adam Cutler – Canaccord
Tom Russo – Baird
Matt Lowe – JPMorgan
Ian Somaiya – Piper Jaffray
Presentation
Operator
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Amylin Pharmaceuticals, Inc. Q1 2010 Earnings Call Transcript
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Amylin Pharmaceuticals, Inc. Q3 2009 Earnings Call Transcript
Welcome to the Amylin Q3 2010 earnings call. At this time participants are in a listen-only mode until the question-and-answer session. This conference is being recorded. If you have any objections, please disconnect at this time.
I would like to introduce your host Michael York, Senior Director, Investor Relations. Sir, you may begin.
Michael York
Good afternoon and welcome to Amylin Pharmaceuticals quarterly update conference call. We have uploaded a presentation to accompany this conference call that provides additional background on the quarter.
Today’s discussion will contain forward-looking statements that involve risk and uncertainties. These risks and uncertainties are outlined in today’s press release, the Web site presentation and in our recent filings with the Securities and Exchange Commission. Our actual results could differ materially from what is discussed on today’s call.
Let me introduce the other members of the Amylin management team here today. Daniel Bradbury, President and Chief Executive Officer; Mark Foletta, Senior Vice President, Finance and Chief Financial Officer; and Vince Mihalik, Senior Vice President, Sales and Marketing and Chief Commercial Officer.
I will now turn the call over to Dan Bradbury.
Dan Bradbury
Thanks Michael, and welcome to our third quarter call. As you are all aware and the reporting of our third quarter earnings were originally scheduled to be held on October 20, and was postponed so that we could update you on the recent regulatory developments related to BYDUREON.
On our regulatory call two weeks ago, I emphasized that we remain confident in the compelling safety and efficacy profile of BYDUREON and are dedicated to bringing this important new therapy to patients with type 2 diabetes as rapidly as possible.
Our rigorous assessment of the EKG data from the Duration program has confirmed for us that BYDUREON has demonstrated no increased risk of cardiovascular complications due to QT prolongation, arrhythmias or conduction disorders.
While the FDA delay is extremely disappointing, especially for the millions of patients today who fail to achieve glycemic control with currently approved therapies, it does nothing to dampen our enthusiasm for BYDUREON as a potential game changer in the treatment of type 2 diabetes.
We intend to meet with the FDA as soon as possible to gain agreement on the design of the requested tQT study to BYDUREON. We assure you that we will provide an update on our regulatory progress with the agency once we have agreement on the study design.
The remainder of our comments this afternoon were built on the press release issued earlier today.
In a few moments, Mark will provide additional details on the quarter’s underlying financial results and comment on our outlook for the rest of 2010. Vince will then review our commercial activity during the third quarter 2010 and highlight our plans for the remainder of the year.
Let me prefix the remarks by highlighting the continued financial discipline that Amylin has demonstrated this year. With our operating expenses remaining consistent with recent quarters, we continue to see the results of our efforts to drive significant efficiencies in our business which have been underway since 2008.
These results are especially critical now with the approval of BYDUREON facing delay. We are in a position to absorb this delay and continue to manage our results in the quarters ahead as we work to complete the final steps towards approval with the FDA. We will provide updated guidance on our year end call after we have finalized our forecast for 2011.
With increased competition, BYETTA prescription trends and revenues declined during the third quarter. However, overall growth of the GLP-1 class remains strong reflecting the market’s recognition of the compelling benefits that GLP-1 therapies offer people living with type 2 diabetes.
Moving forward, we will refocus our efforts to promote the benefits of treatment with BYETTA and SYMLIN that we have established over the past five years.
Finally, as we remain committed to creating sustainable return for your shareholders by ensuring the potential of BYDUREON is maintained in spite of the unfortunate delay, we are also continuing to create value for the advancement of key assets in our product pipeline.
By the end of this year, we plan to submit the clinical and non-clinical sections of our biologics license application BLA for the use of metreleptin to treat severe lipodystrophy, a rare and devastating metabolic disease with no currently approved course of therapy.
Also planned for submission by the end of the year is a supplemental new drug application for the use of BYETTA in combination with basal insulin. Gaining approval of this new indication could bring the benefit of BYETTA therapy to millions of type 2 diabetes patients who currently use basal insulin.
Additionally, we continue to work on key projects designed to enable the advancement of our obesity product candidate pramlintide/metreleptin into Phase 3 clinical studies and are pleased with the progress we continue to make with our partner Takeda.
For more detailed discussion of financial results, I will now turn things over to Mark.
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