Amylin Pharmaceuticals' CEO Discusses Q4 2011 Results - Earnings Call Transcript

Amylin Pharmaceuticals (AMLN)

Q4 2011 Earnings Call

February 06, 2012 5:00 pm ET

Executives

Michael York -

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

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

Analysts

Jim Birchenough - BMO Capital Markets U.S.

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

M. Ian Somaiya - Piper Jaffray Companies, Research Division

Mark J. Schoenebaum - ISI Group Inc., Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

Cory William Kasimov - JP Morgan Chase & Co, Research Division

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

Steve Byrne - BofA Merrill Lynch, Research Division

Yaron Werber - Citigroup Inc, Research Division

Philip Nadeau - Cowen and Company, LLC, Research Division

Presentation

Operator

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Welcome to the Amylin Pharmaceuticals Q4 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, Mr. Michael York, Senior Director, Investor Relations. Sir, you may begin.

Michael York

Good afternoon, and welcome to Amylin Pharmaceuticals' quarterly update conference call. We've 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 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 Amylin management team here today: Daniel Bradbury, President and Chief Executive Officer; and Mark Foletta, Senior Vice President of Finance and Chief Financial Officer.

I will now turn the call over to Dan Bradbury.

Dan Bradbury

Thanks, Michael, and welcome to our fourth quarter and year-end call for 2011. This afternoon, our comments will build on the press release issued earlier today. In a few moments, Mark will provide additional details on our financial results for 2011 and comment on our outlook for 2012.

Our recent announcement regarding the approval of BYDUREON in the United States was the culmination of diligent effort and successful execution. We achieved numerous goals and milestones during 2011 which I'll briefly review before commenting on our focus for 2012.

We achieved successes with both of our marketed products, BYETTA and SYMLIN. Regarding BYETTA, we stabilized revenue and expanded the label such that to date, it has the broadest label of any GLP-1 receptor agonist. We grew SYMLIN revenue as we discontinued the SYMLIN vial and converted patients to the SYMLIN pen.

In addition to the successes we achieved with our marketed products and perhaps most importantly for 2011, we successfully advanced BYDUREON by rapidly responding to the requests outlined in the second complete response letter we received from FDA. Outside the United States, BYDUREON was approved in the European Union and received a favorable recommendation from NICE in the United Kingdom, further supporting the value proposition of this revolutionary medicine.

Looking to ensure long-term shareholder value, we also advanced our metabolic pipeline. We obtained positive results from our proof-of-concept study for exenatide once-monthly suspension program and held a successful end-of-Phase-II meeting with the FDA. We also advanced our program for rare forms of lipodystrophy with a hormone analog, metreleptin.

From a financial perspective, 2011 was also a successful year. We continued to focus on managing expenses in line with revenues, and ended the year with non-GAAP operating income of $25.7 million.

Additionally, during the fourth quarter, we grew revenues for both of our marketed products with BYETTA growing by 3.5% to $132.6 million; and SYMLIN growing by 1.3% to $28.3 million. Our execution of the settlement deal to acquire the global rights to the exenatide franchise rounded out an eventful year for us, and we're now in the best position we've ever been in to successfully launch BYDUREON, the first weekly-dose diabetes therapy in the United States.

2011 truly set the stage for 2012. This year, we have an exceptional opportunity as a company. Following the U.S. approval of BYDUREON on the 27th of January, it is now approved in 31 countries. And with our pending launch in the U.S., we'll soon be launched in 11. We're on the verge of taking a truly remarkable step forward in advancing the treatment of type 2 diabetes and plan on having the product available to patients in the United States on February 17, just 3 weeks following approval.

Our plan to segment our commercial organization into 2 discrete units, 1 focused on exenatide and the other on specialty and orphan products has been implemented now that BYDUREON has been approved. We have completed the hiring of the 325 additional diabetes sales specialists for the exenatide commercial unit. And within the week, we expect to complete the hiring of 65 additional diabetes sales specialists into our specialty and orphan commercial unit. The training of these new specialists has already commenced and we plan to have these new resources fully deployed by the 1st of March. Our existing sales force of 325 diabetes sales specialists is already trained and priming the market for the availability of BYDUREON on the 17th of this month.

With prescriptions for GLP-1 receptor agonists having grown by nearly 50% since February of 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, and the timing of the pending BYDUREON launch could not be better. It is our goal to continue to grow the GLP-1 receptor agonist class with both the launch of BYDUREON and the new BYETTA indication, which is for use in people who have not achieved adequate glucose control with insulin glargine alone. 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 for use in combination with the world's best-selling basal insulin, we have the opportunity to establish a new market for short acting GLP-1 receptor agonists.

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