Amylin Pharmaceuticals (AMLN)

Q1 2012 Earnings Call

April 26, 2012 8:30 am ET


Christine Everett-Zedelmayer -

Daniel M. Bradbury - Chief Executive Officer, President, Director and Member of Risk Management and Finance Committee

Mark G. Foletta - Chief Financial Officer and Senior Vice President of Finance

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

Christian Weyer - Senior Vice President of Research and Development


Alethia Young

Thomas Wei - Jefferies & Company, Inc., Research Division

Thomas J. Russo - Robert W. Baird & Co. Incorporated, Research Division

Karen E. Jay - JP Morgan Chase & Co, Research Division

Unknown Analyst

Christopher Mortko

Nicholas Bishop - Cowen and Company, LLC, Research Division

Terence C. Flynn - Goldman Sachs Group Inc., Research Division

Michael G. King - Rodman & Renshaw, LLC, Research Division

David Friedman - Morgan Stanley, Research Division



Welcome to the Amylin Pharmaceuticals Q1 2012 Earnings Call. [Operator Instructions] This conference is being recorded. If you have any objections, you may disconnect at this time. I would like to introduce your host, Christine Everett-Zedelmayer, Senior Director, Investor Relations.

Christine Everett-Zedelmayer

Good morning, and welcome to Amylin Pharmaceuticals' quarterly update conference call. We have uploaded a presentation to the Investor Relations section of our corporate website at to accompany this conference call that provides additional background on the quarter.

Today's discussion will contain forward-looking statements 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 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 of 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.

Daniel M. Bradbury

Thanks, Christine, and welcome to our first quarter call for 2012. This morning, our comments will build on the press release issued earlier today. In a few moments, Mark will provide additional details on the quarter's financial results and comment on our outlook and guidance for the remainder of 2012. Vince will then review our commercial activity and progress during the first quarter, including an overview of the U.S. BYDUREON launch.

2012 has been a truly exciting year for us so far. We've made substantial progress against many of our key corporate priorities for the year and look forward to continued momentum as we forge ahead.

I would like to take a moment to reflect upon the numerous developments during the course of the first quarter. First and foremost, we accomplished a long-held goal of ours, bringing the first and only, once-weekly therapy, BYDUREON, to type 2 diabetes patients in the United States. This therapy is now approved in 35 markets around the world and has launched in 15 to date. With this game-changing therapy, we are providing patients with an opportunity to control their diabetes instead of letting their diabetes control them.

With BYDUREON, we have set a new bar for the treatment options that we believe will start further innovation and advancements that will continue to revolutionize the development of future therapies for people with diabetes.

Having gained approval for BYDUREON in the United States in late January, we immediately began executing our comprehensive launch plan. With the hard work of the Amylin organization and all our suppliers, BYDUREON was available to patients within 12 business days of approval. We were able to fulfill the immediate orders from wholesalers and enabled dispensing of prescriptions from physicians interested in offering this innovative treatment option with their patients.

We are extremely pleased with the performance of BYDUREON thus far, and are highly encourage with the uptick in demand as BYDUREON continues to gain market share and expand the GLP-1 class.

Specifically, we're encouraged by the response from the high-prescribing, highly-influential physicians, that we have initially targeted.

By following this approach, we are building a strong foundation of long-term growth and adoption within the medical community. We are now 10 weeks into the launch of BYDUREON in the U.S. and it has gained more than 5% of the GLP-1 market. This growth is an addition to BYETTA maintaining 38% market share, establishing its new position in the short-acting GLP-1 receptor agonist class as the only product indicated to be added to the world's best-selling basal insulin.

With prescriptions, the GLP-1 receptor agonists having grown by nearly 60% since February 2010 and the class now approaching 2 billion in global sales, we believe that awareness of the benefits of GLP-1 therapy is at an all-time high. Our focus is on continuing to grow the GLP-1 receptor agonist class through the promotion of our Exenatide franchise.

With BYDUREON, we have the unique opportunity to grow and shape the long-acting GLP-1 market and with BYETTA, the only GLP-1 receptor agonist indicated to be added to the world's best-selling basal insulin, we have the opportunity to establish a new market with short-acting GLP-1 receptor agonist.

We believe our early success is the result of our 2 recently created dedicated commercial units, the Exenatide commercial unit and the specialty and orphan disease commercial units, each with it's own focused sales force, enabling us to devote sufficient attention to our entire product portfolio.

We now have a total of 650 reps hired, trained and in the field, supporting Exenatide, and an additional 65 reps trained and in the field detailing SYMLIN and BYETTA. Vince will provide more detail on commercial activities and the BYDUREON U.S. launch specifics later in the call.

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