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

Steve Byrne - BofA Merrill Lynch Catherine Arnold - Crédit Suisse AG Robyn Karnauskas - Deutsche Bank AG Ian Somaiya - Piper Jaffray Companies John Sonnier - William Blair & Company L.L.C. Thomas Russo - Robert W. Baird & Co. Incorporated Joshua Schimmer - Leerink Swann LLC Matthew Lowe - JP Morgan Chase & Co Yaron Werber - Citigroup Inc Omar Rifat

Welcome to the Amylin Pharmaceuticals Q1 2011 Earnings Call. [Operator Instructions] I would like to introduce your host, Michael York, Senior Director, Investor Relations. Sir, you may begin.

Good morning, 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 morning'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 during today's call. A reconciliation of all non-GAAP financial measures can be found at the end of the website presentation. Let [Audio Gap] 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.

Thanks, Michael, and welcome to our first quarter call for 2011. Before I begin with our prepared remarks, I'd like to say that we are very pleased to announce that BYDUREON has received a positive recommendation from the European Regulatory Authority. We believe the recommendation reflects the beneficial impact of BYDUREON therapy that we have seen throughout the DURATION clinical program. 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. Receiving a positive opinion from the European agency is a pivotal step towards marketing authorization for BYDUREON in the European Union. And in conjunction with Eli Lilly and Company and Alkermes, we look forward to keeping you appraised of further developments regarding our European application. With this positive recommendation, we now expect marketing authorization for BYDUREON within 2 to 3 months in Europe. Regarding the first quarter of 2011, 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 first quarter of 2011. Over the last quarter, we had numerous developments that I'd like to take a moment to reflect upon. Firstly, and most importantly, we initiated a thorough QT or tQT study to address questions raised by the FDA in the complete response letter that was issued in October 2010 regarding our BYDUREON new drug application. As we have previously discussed, the complete response letter requested a tQT study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. In addition to the request for a tQT study, the letter requested the submission of the results of the DURATION-5 study to evaluate the efficacy and the labeling of the safety and effectiveness of the commercial formulation of BYDUREON. With enrollment in the tQT study proceeding as planned, we continue to expect to complete the study in time to submit our response to the agency in the second half of this year. In addition to initiating the tQT study during the first quarter, we also released top line results from two clinical trials, the DURATION-6 study and the Phase II study investigating a monthly dose suspension formulation of exenatide. With regards to DURATION-6, we were disappointed that the study didn't turn out as we had anticipated. And we are closely reviewing all aspects of the trial in an attempt to better understand the data. That said, when looked across the entire duration program, the results we've seen with BYDUREON have been superlative, especially considering the fact that it is a therapy that is dosed only once a week. Moving to exenatide once monthly, we recently reported top line results from a Phase II dose ranging study in which we tested the three doses of exenatide once monthly relative to weekly dose BYDUREON. After 20 weeks of treatment, patients who received just five injections of exenatide once monthly experienced average reductions in A1C ranging from 1.3 to 1.5 percentage points from baseline. This compares to a reduction of 1.5 percentage points seen in the BYDUREON treatment arm. Importantly, both exenatide once monthly and BYDUREON were well tolerated, with more than 90% of patients completing the study. With these encouraging results in hand, we are proceeding with regulatory interactions that outline the next steps to the exenatide suspension program. As a noble formulation of exenatide that incorporates the same microspheres as BYDUREON, exenatide weekly and monthly suspension do not require reconstitution. Additionally, with monthly dosing, exenatide once monthly requires only 12 injections per year. By leveraging the potency of the exenatide molecule into a monthly dose formulation, we believe that we are developing a product candidate that represents an important component of the exenatide franchise and the next evolution of the GLP-1 market. As a pioneer in the development and commercialization of GLP-1 receptor agonist, we have amassed nearly 6 years of market experience with BYETTA, and one of the key takeaways from this experience has been recognizing the importance of convenience and tolerability with regard to driving uptake and maintaining persistence. At the end of the day, getting patients to initiate and remain on therapy is an important part of managing type 2 diabetes. And we believe that if approved, weekly or monthly dosed exenatide will represent attractive options for patients, payers and healthcare providers. As we work to complete the tQT study and advance the exenatide suspension program, we're also continuing our progress on several important life cycle initiatives 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. We are continuing 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. Also announced during the quarter was the voluntary suspension of an ongoing Phase II study examining the safety and effectiveness of pramlintide/metreleptin, our investigational combination therapy for the treatment of obesity. The study was suspended following the discovery of an antibody-related finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity. At this time, we are working with Takeda to further understand this finding to determine the best path forward. Importantly, clinical studies related to our separate development program investigating the use of metreleptin in patients with rare forms of lipodystrophy remain ongoing. At the end of last year, we submitted the clinical and non-clinical 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. We plan to submit the chemistry, manufacturing and control sections and complete the BLA by the end of this year. Being fast track and priority our review designations, metreleptin could be available to lipodystrophy patients in the second half of 2012. Supporting the clinical efficacy profile of metreleptin, data from a new analysis of an ongoing long-term study of metreleptin in patients with lipodystrophy conducted by investigators from the National Institutes of Health, represented just yesterday by our Senior Vice President and Head of Research and Development, Dr. Christian Weyer. The presentation of the 20th Annual Meeting and Clinical Congress at the American Association of Clinical Endocrinologists in San Diego focused on the robust impact metreleptin has on the severe metabolic abnormalities that are associated with lipodystrophy. Overall, these results reaffirm the potential of metreleptin as an important advance in the treatment of people living with this chronic and often debilitating metabolic disease. To round out my comments regarding our progress thus far this year, I'd like to reinforce the fact that while we continue to drive revenue from our marketed products and advance our key pipeline assets, we will continue to aggressively manage our expenses in line with our expected revenues. As Mark will highlight momentarily, our strong first quarter financial results reflect the continued emphasis we are placing on controlling our spending and driving efficiencies across our business. I'll now turn things over to Mark to review our financial results released earlier today.

Thanks, Dan, and good morning. Today, we announced our financial results for the quarter ended March 31, 2011. As Dan mentioned, and we have discussed in previous calls, we are managing the business with operational discipline and are focused on generating sustainable positive operating cash flow and maintaining a strong cash position. Our measure of operating cash flow is non-GAAP operating loss, which approximates our cash flow from operations before working capital changes. Non-GAAP operating loss is defined as our GAAP operating loss adjusted for non-cash items including equity compensation, depreciation and amortization and any other unusual items such as restructuring charges. In the first quarter, non-GAAP operating loss was $3.2 million, an improvement from a loss of $3.8 million in the first quarter of 2010. Total revenues in the first quarter were $152.7 million, a 12% decrease compared to $174.1 million in the first quarter of 2010. Our gross margins remain strong at 92%. Our operating expenses were $106.5 million in the first quarter, consisting of $64.6 million of selling, general and administrative expenses and $41.9 million of research and development expenses. This represents an overall $12 million or 10% reduction from $118.5 million of expenses in the same quarter of last year. This decrease reflects our continued focus on driving efficiencies across our business. For further details regarding our financial results reported today, please refer to the presentation available in the Investor section of our company website. I'd like to make a few additional comments comparing the first quarter of 2011 sequentially to the fourth quarter of 2010. BYETTA sales were down $8.4 million sequentially or 6.2%, which is comparable to the percentage decline in prescriptions during this period. As expected, following the discontinuation of the vial at the end of last year, SYMLIN sales were down $3.1 million or 11.8% sequentially. Encouragingly, sales of the SymlinPen increased 14%, sequentially. Wholesaler inventories at March 31 were comparable to those at December 31, and we believe are consistent with patient demand. In a moment, Vince will speak in more detail regarding our commercial activities. Our non-GAAP operating loss was $3.2 million for the first quarter compared to non-GAAP operating income of $22.9 million in the fourth quarter. Our fourth quarter results were positively impacted by the recognition of the $10 million milestone for the launch of BYETTA in Japan and the impact of our decision to forego a corporate bonus, which benefited the fourth quarter of 2010 by $15 million. Excluding the positive impact of these onetime events, our quarter-over-quarter results were comparable and consistent with our approach to manage expenses in line with revenues. While we will continue to drive efficiencies in our business and manage our spending in line with expected revenues, our current operating model anticipates and requires the launch of BYDUREON in the United States to deliver our stated goal of sustainable, positive cash flow growth. We ended the quarter in a strong financial position with $475 million in cash, short-term investments and restricted cash. I'll point out that that is a $17 million increase from the end of 2010. While this improvement includes the receipt of a $10 million milestone from Lilly for the Japan launch of BYETTA and favorable working capital changes, it also reflects our commitment to continue to tightly manage the use of cash in our business. On April 15, 2011, our $200 million of 2.5% convertible senior notes matured. Adjusted for this debt maturity, our pro forma cash, investments and restricted cash balance at March 31, 2011, was $275 million. To help strengthen our cash balance, we have noticed Eli Lilly of our intent to draw the $165 million line of credit that was made available to us as part of the product supply agreement we entered into October of 2009. If drawn, proceeds from this facility can be used for general corporate purposes and would be due in the second quarter of 2014. As a reminder, we will pay an interest rate of 5.25% plus the 5-day average 3-month LIBOR, which effectively, is an all-in interest rate of approximately 5.5%. And there are no prepayment penalties. I'd now like to provide an update regarding key trends and assumptions for the remainder of 2011. Entering 2011, we guided that the normalized run rate for our quarterly GAAP operating expenses was between $110 million and $115 million and at this level would decline during the year. Our spending was below this range in the first quarter but variability in our quarterly operating expenses is expected. We will continue to drive efficiencies across the organization. Non-GAAP operating results continue to be the key metric we will use to measure our financial performance. We now expect a non-GAAP operating loss at the low end of our previous range of $25 million to $40 million. We expect to earn a $15 million milestone upon the launch of BYDUREON in the European Union. At the end of the first quarter, the cumulative gross margin threshold for sales of exenatide outside the United States was crossed, and we will begin to record royalties in the second quarter this year. These royalties, based on the gross profits outside the U.S., are tiered, and we continue to expect that the total amount earned in 2011 will be less than $5 million. We remain confident that we will be able to maintain strong combined gross margins for BYETTA and SYMLIN of at least 90%. We also continue to expect net interest expense to be $25 million to $30 million. Non-cash adjustments including depreciation, amortization and stock-based compensation are expected to be at the high end of our previous range of $80 million to $90 million in 2011. As I mentioned earlier, we have repaid the $200 million convertible note that is due this month, and noticed Lilly of our intent to draw the $165 million credit facility. To summarize, our first quarter results are a direct result of our ongoing efforts to closely manage expenses. This discipline will continue to be a top priority throughout the year as we strive to achieve additional efficiencies in our business and preserve cash. As we look to the future, we will opportunistically manage our financial risk with a focus on maximizing shareholder value. Now I will turn the call over to Vince to review our commercial activities.

Thank you, Mark. Before I comment on the performance of our marketed products, I'd like to note that as we work to complete the tQT study with exenatide, we are continuing to enroll patients in centers with the EXCEL cardiovascular outcome study and are actively engaged in market development activities to support the successful launch of BYDUREON. With the power of continuous control in just one weekly dose, we firmly believe that BYDUREON is a product that represents an opportunity to revolutionize the way patients and physicians manage their type 2 diabetes. So let's now move on to discuss the BYETTA performance. BYETTA sales decreased approximately 6.2% quarter-over-quarter. The decrease in sales was generally in line with a decline in total prescriptions of 6.6%. Although BYETTA prescriptions declined quarter-over-quarter, we're continuing to observe positive dynamics for the GLP-1 share of the diabetes market during the first quarter. Since the launch of the second daily dose GLP-1 receptor agonist nearly a year ago, 4-week moving averages indicate that the total weekly prescriptions for GLP-1 receptor agonists have grown by approximately 32%. We believe that the steady GLP-1 class growth observed in the U.S. is a clear sign that the market is willing to adopt new entrants into this important class of therapies, a sign that bodes well for the launch of BYDUREON. While the GLP-1 class growth has been encouraging, we believe the class has enormous potential to continue its growth. As such, the core focus of our sales and marketing organization is on driving additional adoption of BYETTA by both patients and physicians who have not yet experienced the benefits of GLP-1 therapy. In support of these efforts, we intend to expand the indication for BYETTA later this year, having submitted a supplementary new drug application for the use of BYETTA with basal insulin in late 2010, we're expecting regulatory action before the end of the year. Based on the data we've seen to date, we are very excited to have the opportunity to make BYETTA available to millions of insulin-using type 2 diabetes patients in the United States. With the potential to provide outstanding post-meal glucose control and help insulin-using patients achieve lower fasting plasma glucose levels and improve hemoglobin A1C relative to patients using insulin alone, we believe that this potential new indication for BYETTA could provide a compelling addition to the choices available to both patients and physicians. Along with the well-established safety and efficacy profile of BYETTA and a heritage established by more than 5 years of market presence, our managed markets team has achieved broad access with managed care plans. Maintaining strong managed care access is a key strategic advantage, and we continue to maintain greater than 80% tier 2 access. Additionally, I'd like to congratulate our managed markets team for being selected by the Health Industries Research Center as the team with the best account managers in a small company category for the second year in a row. Our ability to deliver favorable managed care coverage remains a priority and having a top brained team in place will allow us to maintain strong access for patients using our therapies. Simply put, for patients, providers and payers, BYETTA has a proven and sustained A1C control powerful postprandial and fasting blood glucose reductions, potential for improved beta-cell function, a low risk of hypoglycemia, strong patient support programs and broad managed care access. Now let's move on to SYMLIN, the first and only FDA-approved Amylin analog. As a reminder, SYMLIN is our fully-owned compound that addresses unmet needs for patients with type 1 or type 2 diabetes, who use mealtime insulin. SYMLIN reduces blood glucose fluctuations and improves glucose control, often with weight loss. The first quarter of 2011 was a transition quarter for SYMLIN after more than 5 years of manufacturing and promoting SYMLIN in a vial and syringe presentation, and 3 years in the SymlinPen. We transitioned to a pen-only presentation in January of this year. The SymlinPen now represents approximately 93% of the prescriptions for SYMLIN. SYMLIN revenues decreased by approximately 11.8% during the quarter. The decrease was in line with expectations following the end of our manufacturing and promotion of the vial presentation of SYMLIN, which represented approximately 30% of the 2010 SYMLIN revenue. Until the inventory of vials that remains in the distributions channel has been completed, we expect to continue to see some variability in prescription trends. Let me close my portion of the remarks by saying that we continue to build momentum and enthusiasm and are focused on driving BYETTA and SYMLIN sales. I'll now turn the call back over to Dan for a few additional thoughts.

Thanks, Vince. Before the close of our prepared remarks, I'll just add a few more comments. As we entered the second quarter of 2011, I would like to quickly preview our presence at the American Diabetes Association Scientific Meeting that would be held June 24 through June 28 right here in San Diego. Once again, we are planning to have a significant scientific and commercial presence at that meeting. I am pleased to announce that we have had more than 20 abstracts accepted at the meeting, with additional studies submitted as late breakers. A preliminary list of our abstracts and other activities at ADA will be posted to our corporate website when available. Additionally, the webcast of our annual investor reception at the ADA will take place on Sunday, June 26, at 7:30 p.m. Pacific Time. We look forward to seeing many of you in San Diego as we review meeting highlights and take questions. I'm also pleased to note that we will be holding our 2011 Annual Meeting of Stockholders on Tuesday, May 24, at 9 a.m. Pacific Time here in San Diego. For those stockholders who aren't able to attend the meeting in person, we invite them to listen to the webcast of the meeting, followed by a corporate overview. We look forward to this opportunity to provide additional updates about Amylin and meet with our stockholders in person. In closing, I'd like to reiterate that I, along with the Amylin leadership team, remain committed to creating value for our shareholders, our employees and most importantly, the millions of diabetes patients we are focused on serving. Additionally, like to thank each and every one of the Amylin employees for their dedication and commitment to this focus. I'll now ask the operator to open the lines for questions.

[Operator Instructions] Our first question comes from Joshua Schimmer with Leerink Swann. Joshua Schimmer - Leerink Swann LLC: Thanks for taking the questions. First, on the once a month exenatide, do you have any expectations what that regulatory path might look like for what you're going to propose?

The big advantage that we have with the suspension program, both the weekly and the monthly, is that they will both be line extensions of BYETTA which, of course, having been in the market now for six years, we'll be able to reference that data set. Our expectation is that it would be similar to BYDUREON and that it'd be a 505(b)(1) application. And as such, would leverage all the data sets that we have on both BYETTA and BYDUREON as part of that application. Joshua Schimmer - Leerink Swann LLC: Great. Does that mean that a single Phase III study would suffice or do you expect it will require more?

Well, if that's the case, Josh, that will be consistent with the guidance that the FDA gave us for BYDUREON. As you know, the regulatory parts of BYDUREON hasn't been as straightforward as that. So we are currently planning to have a discussion with the agency before confirming the regulatory path forward. Joshua Schimmer - Leerink Swann LLC: Great. And then on BYETTA under the doughnut hole and the co-funding requirement, did you see any impact on this? When do you expect this impact to be greatest, and are you able to now quantify the impact that the doughnut hole will have, at least, in terms of on the cost side and covering half the patients?

Yes. Okay. That's a great question. I'm going to ask Vince to comment on that, Josh.

Yes, Josh, thanks for the question. Actually, we've been expanding the, I'd say, the access we have in Medicare Part D. And as a result, we had a very small exposure initially to the Healthcare Reform Act, and the doughnut hole did have some -- it usually does have some impact in the first quarter of every year. We do usually see a bump back up. This particular quarter, the diabetes market was relatively flat. We didn't see much of an expansion in the overall market. We're continuing to assess our risk, however, under the Healthcare Reform Act. It has had some minor implications for us to date, and we've included those in our financials. But overall, our exposure is not that broad. Joshua Schimmer - Leerink Swann LLC: Okay. Thanks very much.

Our next question comes from Mark Schoenebaum from ISI Group.

This is Omar filling in for Mark. Just wanted to start out by asking very quickly BYDUREON's ex-U.S. launch price, can we get a sense of that?

Well, until we get actually approval in Europe, I don't expect that we'll be providing any guidance with regards to the European launch price. I should say also, that is the responsibility of Eli Lilly and Company since they're responsible for all commercialization of exenatide products outside the United States.

Sure. And then a quick follow up, is it reasonable to expect detailed DURATION-6 data at ADA?

No, I don't think it is. The reason I say that is that we are still undertaking an investigation of the DURATION-6 study, and I doubt that that will completed and certainly not available in time for submission, even as a late breaker to the ADA.

Great. And then just a final quick one, possibly for Mark, going towards the end of the year, I noticed consensus expectations are that the expenses may roughly stay flat. Just wanted to get a sense of how the SG&A spend, especially, might ramp-up as we head closer to a possible resubmission of BYDUREON and the possible launch next year?

Yes, sure. Mark?

Yes, thanks, Omar, for the question. I think it's fair to say, we've been working on our operating model intensely over the last several years as you know. And we guided that we entered the quarter with operating expenses of -- entered the year with operating expenses of $110 million to $115 million. We actually came in below that range in the first quarter at about $106.5 million. We expect some variability there moving forward. But the operating model is in place to launch BYDUREON. And I think that's the important answer to your question. We don't anticipate significant changes other than customary launch-related expenses to launch BYDUREON.

Great. Thank you very much.

Our next question comes from Robyn Karnauskas with Deutsche Bank. Robyn Karnauskas - Deutsche Bank AG: Thanks for taking my question. So, Omar has stolen my questions but, I guess, one of my key questions is, have you got any sense now from talking with Lilly regarding why DURATION-6 might have come out the way it did? Any other nuances that you've noticed when you've taken a closer look at the data?

I'm afraid you're going to have talk to Omar regarding his questions. But to answer your question directly, no. At this point, really, we can't provide any guidance. We're really at the -- still very much at the beginning of the investigation into the outcome of DURATION-6. I mean, that having been said, we do expect that we will complete that this year, and that the results we'll be able to report at the scientific meeting in the future. Robyn Karnauskas - Deutsche Bank AG: Great. And then I guess my next question is regarding the EU market. Can you help us think a little bit through how you see that market shaping up for the GLP class?

Yes, certainly, Robyn. I'm going to ask Vince to answer that question for you.

Thanks, Robyn. Robyn, obviously, we're seeing very good growth and adoption in Europe relative to the GLP-1 class. And, in fact, the market has gone up about 83% since the launch of both GLP-1 receptors agonists in the European marketplace. And so I think the overall adoption of the GLP-1 class and especially the response to the second GLP-1 receptor agonist, certainly bodes well, I think, for BYDUREON with its continuous control with once-week dosing. Robyn Karnauskas - Deutsche Bank AG: And I guess lastly, the overall growth of the market, as far as the GLP class in the United States, and I know as of the last 2 or 3 quarters ago -- 3 months ago, that the GLP class sort of stalled and grown and then stalled. Any update on the overall growth of the GLP market as far as percentage of Asians with diabetes patients on GLPs?

In fact, Robyn, we are seeing about a 30% growth in volumes since about a year ago, and about 25% share growth in the diabetes class since about a year ago. And when you talk to physicians, particularly endocrinologists, most of them, 3 out of 4, say they are going to increase their use of GLP-1s in the future. So I think it bodes well for the continued growth of the GLP-1 class. And keep in mind that greater than 70% of all the scripts are coming from PCP. So, all in all, I think we're going to continue to see this class grow over time. Robyn Karnauskas - Deutsche Bank AG: Okay, well, thank you.

Our next question comes from Ian Somaiya, Piper Jaffray. Ian Somaiya - Piper Jaffray Companies: Thanks. Just a couple of questions. First, on the DURATION-6, Dan, maybe you could just talk to what type of analysis you're doing with the trial? What questions you're trying to get answered? And then I just had a follow up on the European approval.

Yes, sure. For DURATION-6, I think it's really looking at the overall conduct of the study. This study was conducted in 19 different countries. There was multiple sites in many of those countries. And -- sorry, about 120 sites, apparently, overall. And so, it's really looking at the conduct of those sites and making sure that it's been completed. The study was completed appropriately. I think also looking and making sure that there are no issues with regards to drug supply in terms of how the drug was supplied and the storage of drug, et cetera, during the conduct of the study. Ian Somaiya - Piper Jaffray Companies: Is there any early evidence that there might have been a geographic bias or issues in certain...

Well, I think just to say that we were surprised with the outcome of the study. It wasn't what we expected, clearly, from a BYDUREON standpoint. Having completed 5 other studies and each of those studies having got greater A1C reductions than we saw in DURATION-6, I think it's reasonable for us to investigate the conduct of the study. Ian Somaiya - Piper Jaffray Companies: Okay. And just on the European, the CHMP review or recommendations for approval, what is their view of the drug's effect on QT? How does that differ from the U.S.? And I don't know if there was any additional data that was submitted to the EMEA, which maybe wasn't submitted to the FDA?

There was no additional data submitted to the EMEA that was not submitted to the FDA. That would not be a good thing to do. And just to say that as far as we're aware, at this point, the prescribing information does not include any additional comment on QT. We have to wait for the final label. We haven't received that yet, of course, because what we've received so far is the CPMP recommendation for approval and not the final approval in Europe, which we'd expect to receive within 2 to 3 months.

Our next question comes from Yaron Werber with Citi. Yaron Werber - Citigroup Inc: Thanks for taking my question. So I just had 2 or 3 questions, the first one actually is metreleptin. The data continues to look very, very good. As we all know, these markets are not very big, and you guys did not conduct any sort of prospective studies. Most of the data that's been presented and been published, as you mentioned, is from the NIH. Can you give us a little bit of a sense how much buy in do you have from FDA at this point to file and ultimately get approved, and how do you think about this opportunity? And then I had a follow up.

Sure. Well, Yaron, thanks for the question. And you're actually right. I mean, the data continues to look very, very positive with regards to the benefits of metreleptin in patients with these rare forms of lipodystrophy that we're treating. In terms of buy in from the FDA, we have orphan drug designation. We've got that prior to the submission of the first part of the BLA that went in at the end of last year. That was the clinical and non-clinical sections. And obviously, before we submitted that, we reviewed with the agency the data that we had. And we were informed that, that would be adequate for review. So in terms of -- I think, we have about as much as buy in as could be expected from the agency prior to completion of the review. Our intention is to complete the application later this year by submitting the chemistry, manufacturing and controls section of the BLA by the end of this year. And we do expect that we will submit at that point for priority review. And if that's granted, then there's the potential for us to gain approval by the second half of 2012. The way we think of it is, at this time, we're still, I think, finalizing our commercialization plans. You're absolutely right. It's not a very significant number of people. When you look globally, it's probably less than 3,000 people here in the United States, somewhere in the region of around 1,000 to 1,200 patients is probably what we're looking at. We're actually, at this point, undertaking some epidemiology work to get a good idea or a better idea, I should say, of the exact opportunity. But I think it's fair to say that this is very much an ultra orphan product. And as such, we'd be looking to commercialize it in a similar manner to drugs of that nature that have been commercialized in the past. Yaron Werber - Citigroup Inc: That's really useful. And then just for ADA, are there any plans to present any QTC data on BYDUREON?

So the specifics of our ADA abstracts, we haven't released yet. But I think you could be assured that we will have our usual investor meeting at the ADA and expect that there will be a full review of appropriate data at that meeting. Yaron Werber - Citigroup Inc: Okay, great. Thanks, Dan.

Our next question comes from Catherine Arnold with Credit Suisse. Catherine Arnold - Crédit Suisse AG: Thanks. I wanted to ask you about cash flow, and I also wanted to ask you about monthly BYDUREON. So maybe I'll throw the cash flow questions and we can come back to the monthly BYDUREON. So on cash flow, I was wondering if you could talk about the possibility for refinancing your converts, and how you're thinking about that with 2014, obviously, being a big year for that obligation. And I'm also wondering on cash flow presenting opportunities to improve working capital so that you can help your cash flow position in the next 3 to 5 years.

Thanks, Catherine. I'll ask Mark to take that.

Yes. Thanks, Catherine, I appreciate the question. As we said in the prepared remarks, we did pay off the $200 million convertible debenture last Friday. We thought that, that was the most appropriate thing in the interest of shareholder value to do that at this time. Obviously, we have a number of milestones coming forward to be able to opportunistically address the debt, the 2014 debt, including the potential drawing of the Lilly loan. We've worked very hard, as you know, on our operating model over the last couple of years to manage expenses in line with revenues. And as we said in the prepared remarks, the opportunity for significant cash flow growth comes with the launch of BYDUREON. Certainly encouraged now that we have the first step in motion to get the product, to make the product available to patients in Europe. And that will certainly begin to provide us some financial rewards and the leverage that we will need to drive margins for that product moving forward. We've made significant investments and as you know in a plant, including a pen line. So we're set up very well to take advantage of the launch of BYDUREON globally. And as I said, we've got some time before the maturities that you've referred to, and we'll certainly look to opportunistically finance those in the future with the interest of maximizing shareholder value. In terms of your question on working capital, I want to make sure I'm clear on the question. Could you repeat it? Catherine Arnold - Crédit Suisse AG: Yes. I just wondered if there's an opportunity to change some of your metrics on working capital, whether it's accounts receivable or inventory, where you might have a chance to start to bring some of those numbers down to maximize your cash flow?

Yes, well, that's been a focus. Our receivables turn very, very quickly. I mean in this industry, you get paid very fast on your receivables. So that's not really an issue for us. In terms of inventory, we do have some inventory on the balance sheet, in terms of API for both of our products. Much of that is tied to BYDUREON because we've built some inventory in advance. So I think you would look to see those metrics approved as we go forward again, tied to the launch of BYDUREON. Catherine Arnold - Crédit Suisse AG: Great. And I wanted to ask you about the monthly BYDUREON. Could you talk about PK? There is some variability, obviously, in a once weekly BYDUREON versus BYETTA. And I am just wondering how we should be thinking about what PK variability exists with that product. And also not from a regulatory perspective and requirements, but would you see yourselves for competitive reasons doing a duration-like program on a monthly?

Yes, I think in terms of PK, we will be presenting data on the program at a future scientific meeting. But I would remind you that the formulation that we're using is the same formulation that was used in BYDUREON. And that formulation was actually initially designed to be a monthly product. So we don't expect to see very substantial increases in variability from a PK standpoint. There will be some because you reduced your dosing frequency. But we don't expect, in fact, we have not seen very significant increases in PK variability. In terms of your second part of your question regarding doing a DURATION-like program, I think once we get guidance from regulatory authorities with regards to what the appropriate program would be for approval, we'll then make further decisions with regards to whether or not any additional studies would be warranted for the monthly program. Catherine Arnold - Crédit Suisse AG: Thanks very much.

Our next question comes from Cory Kasimov with JPMC. Matthew Lowe - JP Morgan Chase & Co: This is actually Matt Lowe in for Cory today. Many of my questions have been answered. But if I could just kind of revisit the European market for BYDUREON. Just wondering if you're expecting any kind of significant differences in that market versus what we might see in the U.S., and if you could also just speak to the commercial impacts of DURATION-6? Thanks.

Thanks to your question. I'm going to ask Vince to answer both those questions regarding Europe and also the impact of DURATION-6. So, Vince?

Yes. Thanks, Dan. On the European market, obviously, as I was commenting earlier, we are seeing really good growth in adoption for GLP-1s in the European market. Of course, it varies by country and also varies by the reimbursement system. But for the most part, we are seeing major expansion, literally, more than doubling of the GLP-1 market in each of those countries. So with the launch of a second GLP-1 receptor agonist more, I would say, voices in the market, we're beginning to see greater expansion in the diabetes market of the GLP-1 class across all of Europe. So I think that bodes well for BYDUREON's presence in the European market. As it relates to the DURATION-6 and again, Dan made this comment that when you look across all of the DURATION series, and we look at A1C reductions across a wide range of patients with multiple different therapy backgrounds, we were really surprised at the results. If I take that forward, however, keep in mind that this is a very small difference statistically, so to speak, in hemoglobin A1C but not a very big difference clinically. And most physicians do weigh a number of variables in choosing what medication they're going to provide for patients. They look at efficacy. They look at safety. They look at tolerability. They look at convenience. They look at adherence, and they look at access. And all those things play together before they decide what particular medication they're going to give a patient. And if I again look at DURATION-6, BYDUREON demonstrated outstanding tolerability and, again, continuous control, glucose control, with a once weekly dose. So I think when physicians look across the entire range of DURATION-6 studies, when they look at the advantage of continuous control with once weekly dosing, the great tolerability potential for weight loss, its comparison to other most frequently prescribed anti-diabetes medications, I think it bodes very well for BYDUREON's competitiveness. Matthew Lowe - JP Morgan Chase & Co: Yes, okay. That's great. Thank you.

Our next question comes from Steve Byrne with Bank of America. Steve Byrne - BofA Merrill Lynch: Thank you. So relative to the sales of BYETTA, the collaborative profit sharing seemed a little bit higher than expected. I appreciate your efforts at lowering SG&A, but is there anything to a potential offset of your efforts by increased selling expense by Lilly and you have to true that up in that line item?

Steve, the collaborative profit sharing is 50% of the gross margin of BYETTA. I don't think it's out of line from any other quarter. So I'm not sure if I'm clear on your question. Steve Byrne - BofA Merrill Lynch: But if you're selling expense differs materially from Lilly's, isn't there a true-up in that line item?

No, we true that up right through the SG&A line item, so any true-up there... Steve Byrne - BofA Merrill Lynch: That's in your SG&A. That true-up is in your SG&A?

Yes. Steve Byrne - BofA Merrill Lynch: So your gross margins on BYETTA are greater than they are in SYMLIN?

Yes. We're over 90% on BYETTA and so you should think of a collaborative profit-sharing line as pretty pure as 50% of the U.S. gross margin. Steve Byrne - BofA Merrill Lynch: And then I have a question on the once monthly for Vince. In your market research, do you see that the potential driver for this product being attracting those patients that are already GLP-1 patients? Or do you see that the once monthly could meaningfully pull in patients that are using other anti-diabetic therapies?

Thanks, Steve, for the question. And yes, I think you could say yes to both parts of that question. I think you're going to see patients who have started on GLP-1s. We have already good compliance and good adherence; want to move to a once monthly given their experiences and the ease and convenience of once-month dosing. And I think as well physicians may look at patients who are out of control, who have difficulty with adherence moving to once a month dosing because of its convenience and adherence. So I think you could say yes to both sides of that equation. Steve Byrne - BofA Merrill Lynch: Okay, thank you.

Our next question comes from Tom Russo with Baird. Thomas Russo - Robert W. Baird & Co. Incorporated: Just putting some of the same topics, for DURATION-6, is part of the analysis and do you have any sense yet of when patients reached steady-state versus the six-month measurement of A1C? And did you continue any patients out beyond six-months in that study?

No. In terms of DURATION-6, we actually don't have any analysis at this time that I can comment on. But also, there was no extension to this study. So we don't have any information for patients who went beyond that six months period. Thomas Russo - Robert W. Baird & Co. Incorporated: Okay. And then on the once monthly, can you give any additional color on which dose had the 1.5% reduction in A1C and also can you say anything about weight loss versus BYDUREON in that study?

Just to say that, well, we haven't the given any specifics with regards to the dosing information. That will be presented at a future scientific meeting. We're also, at this point, completing our work to make the final dose selection and that has not been made at this time. With regards to weight loss, I would just say that weight loss was consistent with that seen in previous studies with BYDUREON. Thomas Russo - Robert W. Baird & Co. Incorporated: Okay. And last question, I think, maybe for Mark, the economics to Amylin from BYDUREON in Europe, I think you might have said in the past where the royalties start and can you also give any color, and can you confirm kind of where the royalties start and then whether the first step up in the tier is above or below the current run rate for BYETTA in Europe?

Yes, Tom. Thanks for the question. Yes, we did guide that this year, we expect to get -- we crossed the threshold actually right as we exited the quarter and we'll expect to begin to earn royalties relative to BYETTA in the O.U.S. market. With the BYDUREON launch, obviously, we'd expect revenue growth. But I think it's important to remind you the discussion we've had in the past about the gross margin transition for BYDUREON. This royalty is pegged to gross margin, and it is tiered. And we are currently -- as we move in the second half of the year, be in a kind of low- to mid-single digit percentage of gross margins or of royalty on gross margin. And we would expect a few years, Tom, to be able to drive the leverage within the margin line to be able to drive to the next tier. So I think, as you think of your models, obviously, it's very early in terms of thinking of a revenue line for O.U.S. But we would guide you to be conservative in terms of thinking of our margins over the next few years as we drive the leverage at the gross margin line with our plant in Ohio. Thomas Russo - Robert W. Baird & Co. Incorporated: Okay. Thanks, Mark.

Our last question comes from John Sonnier with William Blair. John Sonnier - William Blair & Company L.L.C.: Thanks for taking the question. Just a quick one on once monthly. I'm wondering, Dan, I guess, if the super therapeutic concentrations of exenatide that you've used in the tQT study exceed the concentrations of exenatide injected once monthly or if it's possibly you're going to have to push the dose or do a separate tQT trial for once monthly?

Thanks, John. Nice to hear your voice. Just to say that we expect that the tQT study that's being conducted now would be adequate with regards to providing any assurances with regards to any effect on exenatide on QT prolongation or not. This case, as we don't believe will be the case for exenatide once monthly. The plasma concentrations that we expect to see with monthly are subject to the dose that we would select for that product. But even in the case of patients who would have some forms of renal impairment, we would expect that the data that we would generate from the ongoing tQT study would be adequate for us to be able to model what would be expected for those patients from that study. So our expectation is that the tQT study that's ongoing would be adequate for any submission for a monthly program. John Sonnier - William Blair & Company L.L.C.: That's helpful. Thanks so much.

That does conclude the Q&A.

Thanks very much, everybody. Again, thanks for your interest and for your questions today. We have a huge opportunity as a company to continue to advance our mission of discovering and developing and commercializing medicines to improve the lives of patients. Additionally, our leadership team and the many dedicated employees of Amylin remain focused both on building the business today and laying the necessary foundation for our success tomorrow. If you have any additional questions from the call today, please call Michael York, the Head of our Investor Relations team. Thank you.

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