Amylin Pharmaceuticals (AMLN)

Q3 2011 Earnings Call

October 19, 2011 5:00 pm ET


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

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

Michael York - Senior Director of IR

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


David Friedman - Morgan Stanley, Research Division

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

Salim Syed

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

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

Unknown Analyst -

M. Ian Somaiya - Piper Jaffray Companies, Research Division

Kumaraguru Raja

Catherine J. Arnold - Crédit Suisse AG, Research Division



Welcome to the Amylin Pharmaceuticals Q3 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

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.

This afternoon's discussion will contain forward-looking statements that involve risk and uncertainties. These risk 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. A 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 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 for 2011. This afternoon's call regarding our third quarter results will build on the earnings 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 remainder of 2011. Vince will then review our commercial activities during the third quarter of this year.

Over the last quarter, we continued to execute our business plan and have made substantial progress against our objectives for the year.

Revenues from our marketed products, BYETTA and SYMLIN, remained steady quarter-over-quarter, and our focus on managing expenses and maintaining financial discipline enabled us to continue running our business close to breakeven. In fact, we earned non-GAAP operating income of $13 million during the third quarter.

Earlier in the quarter, we announced that we had responded to the second BYDUREON complete response letter. And based on ongoing interactions with the FDA, we continue to expect that their review will be completed by January 28 PDUFA date. We are continuing pre-launch activities and we'll be in position to have BYDUREON available to patients shortly after approval.

The anticipation of launching BYDUREON here in the United States has us and the broader diabetes community buzzing with excitement. With BYDUREON now available in the U.K. and, more recently, Germany, this sense of excitement continues to grow, with early feedback from patients and healthcare practitioners in both markets being overwhelmingly positive. Though it's still too early in both launches to have solid data regarding prescription volume, demand in wholesale channels has been very strong particularly in Germany.

We also continue to make excellent progress on several important pipeline and life cycle initiatives. We continue to look forward to the FDA's anticipated decision within the next week on an expanded label for BYETTA for use with insulin glargine, which would result in an important new treatment option for patients. The development of a pen device for BYDUREON remains on track, with an expected launch by the end of 2012 or in early 2013.

Regarding the exenatide suspension program, we expect regulatory interactions by the end of the year that will inform the design of pivotal studies for both the weekly and monthly exenatide formulations. And we will provide you with an update about our plans for this important initiative following those interactions.

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

In addition to the exciting progress we're making with our exenatide franchise, we continue to make progress with metreleptin for rare forms of lipodystrophy. At the end of last year, we submitted the clinical and nonclinical sections of a Biologics License Application or BLA for the use of metreleptin to treat diabetes and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. Our plan at the start of this year was to submit the chemistry, manufacturing and control sections and complete the BLA by the end of this year.

We have successfully completed the drug substance validation runs and are now in the process of generating stability data in support of our planned submission. However, capacity issues with our contract manufacturer and complexities encountered during the validation runs have caused us to move our target date for the BLA completion into the first half of 2012.

We remain committed to bringing this new therapy to market as soon as possible and we'll be providing an update regarding the commercial outlook for the lipodystrophy opportunity at the beginning of next year.

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