Amylin Pharmaceuticals (AMLN)

Q2 2011 Earnings Call

July 26, 2011 8:30 am ET

Executives

Vincent Mihalik - Chief Commercial Officer and Senior Vice President of Sales & Marketing

Michael York - Senior Director of IR

Mark Foletta - Chief Financial Officer, Principal Accounting Officer and Senior Vice President of Finance

Dan Bradbury - Chief Executive Officer, President, Director and Member of Risk Management & Finance Committee

Analysts

Cory Kasimov - JP Morgan Chase & Co

Alethia Young

Terence Flynn - Goldman Sachs Group Inc.

Catherine Arnold - Crédit Suisse AG

Thomas Russo - Robert W. Baird & Co. Incorporated

Omar Rifat

Matthew Luchini

Philip Nadeau - Cowen and Company, LLC

Kumaraguru Raja

Presentation

Operator

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» Amylin Pharmaceuticals, Inc. Q2 2010 Earnings Call Transcript

Welcome to the Amylin Pharmaceuticals Q2 2011 Earnings Call. [Operator Instructions] 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

[Audio Gap]

Provides additional background on the quarter. This morning's discussion will contain forward-looking statement that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release, the website presentation and in our recent filings with the Securities and Exchange Commission. Our actual results could differ materially from what is discussed during today's call. The reconciliation of all non-GAAP financial measures can be found at the end of the website presentation.

Let me introduce the other members of the Amylin management team for 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. Before I begin with our prepared remarks, I'd like to say that we were very pleased to note that during the quarter, BYDUREON received marketing authorization from the European regulatory authorities. And our partner, Eli Lilly and Company, recently launched the product in the United Kingdom.

The availability of the first weekly-dosed diabetes therapy in Europe marks a milestone for patients, physicians and the healthcare system. With just one dose per week, BYDUREON has consistently demonstrated in patients with type 2 diabetes powerful glucose control, the potential for weight loss and a favorable safety and tolerability profile. The opportunity to monitor the early stages of the launch in the United Kingdom and in other European countries gives us the opportunity to apply the insights we gained for the planned U.S. launch.

Now shifting back to our second quarter results, our comments this morning will build 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 2011. Vince will then review our commercial activity during the second quarter of this year.

Over the last quarter, we continued our focused execution against our business plan, and I will take a moment to highlight our substantial progress. At the end of the quarter, we completed the thorough QT or tQT study for exenatide to address questions raised by the FDA in the complete response letter that was issued in October 2010 regarding our BYDUREON new drug application. The results, which we announced earlier this month, indicated that when using multiple heart rate correction methodologies, the study met the pre-specified primary endpoint demonstrating that exenatide, at and above therapeutic levels, did not prolong the corrective QT interval in healthy individuals. Additionally, the study found no relationship between QTc interval and the plasma exenatide concentrations. With the tQT study now complete, we expect to submit our response to the agency by next week.

We expect the submission of the tQT study data, along with DURATION-5 and the integrated safety update to be classified as a class 2 resubmission and be granted a 6-month review timeline by the FDA. In addition to being positioned to respond to the FDA regarding the most recent BYDUREON complete response letter, we continued to make excellent progress on several important life cycle initiatives, which represent the next drivers of growth for BYDUREON and the exenatide molecule.

The development of a pen device for Bydureon remains on track with an expected launch by the end of 2012 or in early 2013. Data from a Phase II study of our once-monthly injectable suspension formulation of exenatide showed the clinical profile comparable to BYDUREON, with substantial improvements in glycemic control. We expect regulatory interactions by the end of the year that will inform the design of the pivotal studies for the exenatide suspension program.

We have also continued to add centers and enroll patients for our ongoing EXCEL cardiovascular outcomes study, which is investigating the potential for BYDUREON to reduce cardiovascular events relative to the standard of care in patients with type 2 diabetes.

We also had a strong presence at this year's American Diabetes Association conference in June, with new data from more than 20 abstracts supporting safety and efficacy profiles of BYETTA, SYMLIN and BYDUREON. Of particular interest was an analysis of a large healthcare claims database showing that when compared to other diabetes therapies, use of BYETTA was associated with a 54% reduction in the likelihood of developing heart failure. This was a truly astounding finding, and I'd like to take a moment to highlight the devastating intersection between type 2 diabetes and the cardiovascular disease.

At this juncture, it is clear that type 2 diabetes is a major risk factor for developing numerous forms of cardiovascular disease, with a growing repository of clinical and epidemiological studies supporting this fact. It is estimated that more than 3 quarters of U.S. hospitalizations for complications associated with diabetes are a result of cardiovascular disease, and that nearly 2/3 of type 2 diabetes patients will die from cardiovascular disease.

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