Good day ladies and gentlemen and welcome to the first quarter 2009, Amylin Pharmaceuticals Incorporated earnings conference call. My name is Stacey and I’ll be your conference moderator for today. At this time all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of the conference. (Operator Instructions) I would now like to turn the presentation over to your host for today’s call, Mr. Michael York, Senior Director of Investor Relations; please proceed.

Good afternoon. Welcome to Amylin Pharmaceuticals quarterly update conference call. Today’s discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today’s press releases 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; Vince Mihalik, Senior Vice President of Sales and Marketing and Chief Commercial Officer; and Orville Kolterman, Senior Vice President, Research and Development. I’ll now turn the call over to Dan Bradbury.

Thanks Michael. This afternoon we will build on the press release issued earlier today and provide additional color in detail around the company’s progress and performance in the first quarter. We’ll then update you on the five primary areas that we are focusing on, to create value for Amylin shareholders. These are (1) BYETTA; (2) exenatide once weekly; (3) SYMLIN; (4) our obesity programs and (5) improving our operating results. First, I want to frame the call with our major highlights of the first quarter and remind you that we have uploaded a presentation on our website that provides additional background on the quarter. (1) We improved our non-GAAP operating loss by 55% over the same period in 2008 and we remain on track to achieve our stated business objective of generating positive cash flow from operations by the end of 2010. (2) We have strengthened our alliance with Eli Lilly and Company an initiated ExenatideOne; an integrated co-located medical development and commercial team for the exenatide franchise. I will comment on this exciting development later. (3) We reported positive results of exenatide once weekly from DURATION-2; the first comparative efficacy trail ever undertaken against maximum dose of two commonly used brands, Actos and Januvia. Now, I will highlight our progress on the five areas I mentioned earlier. First is BYETTA; the only GLP-1 receptor agonist currently on the market, which was added late last year to the American Diabetes Association treatment guidelines the type 2 diabetes. In spite of the addition the revise treatment guidelines, BYETTA sales have remain relatively flat quarter-over-quarter, due in part to the overhang of concerns regarding pancreatitis, as well as broad economic factors that appear to be impacting the way people with diabetes are managing their diseases. Vince and Orville will comment on these…

Thanks Dan and good afternoon. I’ll start by quickly reviewing selected first quarter figures from our earnings release earlier today. As I discussed last quarter, the key metric to track our progress is non-GAAP operating loss. We believe this metric is an important measure of the performance of our business, as it approximates our use of cash for operations before working capital changes, as we drive towards our stated goal of positive operating cash flow by the end of 2010. As a reminder, non-GAAP operating loss is defined as our GAAP loss, less non-cash items, principally equity compensation, depreciation, amortization and any one-time charges. Non-GAAP operating loss was $19.9 million compared to $44 million for the same period in 2008, a $24.1 million or a 55% improvement. Total revenue was $193.7 million, including net product sales of $179.3 million in the first quarter, compared to total revenue of $197.2 million, including net product sales of $178.7 million for the same period in 2008. Product sales in the first quarter were $157.7 million for BYETTA and $21.6 million for SYMLIN. Net product sales in the first quarter were impacted by a reserve of $5.8 million associated with the Tricare Retail Pharmacy program; the majority of which relates to BYETTA and represents rebates retroactive to January 28, 2008, pursuant to a final rule implementing this program that was issued last month. Of this $5.8 million, $4.8 million relates to retroactive rebates for 2008. Excluding the impact of the Tricare reserve, net product sales for BYETTA were $163.1 million for the first quarter, compared to $158.5million for the same period in 2008. Net product sales for SYMLIN excluding the impact of the Tricare reserve was $22 million in the first quarter, compared to $20.2 million for the same period in 2008. Cost of…

Thank you Mark. I will now provide an update on our commercial activities here at Amylin. First, I want to start by reinforcing my commitment to accelerate the growth of BYETTA and SYMLIN, as well as maximize the launch of commercialization of exenatide once weekly. We have an opportunity to help more patients, comprehensively manage their diabetes and we’ll do just that. To accomplish these objectives and be more effective and operationally and financial efficient in our commercial activities, we are restructuring exenatide operations with Lilly and we are creating a more integrated efficient approach to development, sales and market for BYETTA and exenatide once weekly. In this restructuring named ExenatideOne, we have created one integrated team to drive our plans and address competitive dynamics in the marketplace. Clearly, ExenatideOne demonstrates both Lilly and Amylin’s long term commitment to the exenatide franchise. The integrated team, which will be located here in San Diego, will report to the alliance steering committee, co-chaired by Dan Bradbury and Bryce Carmine, who is the Global Head of Sales and Marketing at Lilly. This closer engagement of senior leadership reflects the shared vision of Amylin and Lilly. ExenatideOne is a single commercial Medical and Research Development team with single accountability for aligning strategy and a tactical execution. I expect this integrated and collocated team to help me turn BYETTA to grow and to effectively launch once weekly. I want to thank our colleagues at Lilly for working with us on this truly unique and integrated approach, to commercializing the Exenatide franchise and I expect additional enhance to the alliance as we go forward. Now, I’ll provide a brief overview on the current business. As noted earlier, 2009 we’ll marked the fourth year on the market for BYETTA and it has been used by more than…

Thank you Vince. As Dan mentioned earlier, we continue to work to better understand the relationship between BYETTA and pancreatitis described in some spontaneously reported cases. In keeping with our focus on patient safety, we continue to pursue our drug safety program that includes thorough investigation of individual’s spontaneous case reports, along with clinical and epidemiological studies. Within the detection limits of an initial epidemiology study, we have not observed an increased incidence of pancreatitis associated with BYETTA compared to other treatments for diabetes, and thus believe a definite causal relationship between BYETTA and pancreatitis as not been proved. This data was published in Current Medical Research and opinion found that the risk of acute pancreatitis among initiatives of BYETTA or sitagliptin was similar to initiatives or metformin or glyburide to older more traditional therapies. Additionally, another study published last quarter also helped to furether characterize pancreatitis in the type 2 diabetes population. This manuscript published in diabetes care downs the risk of pancreatitis in patients with type 2 diabetes to be roughly three times that of people without diabetes. The FDA is continuing with its review of the regulatory application from monotherapy and several other prescribing information updates; including revision of safety language, including pancreatitis. While this process has taken considerable time, we continue to be encouraged by our interactions with the FDA and a careful review of the data we have provided and remain confident of resolution of this issue in the near future. Again, we continue to further understand this relationship and have shared the recently published studies and other information with the agency. We believe that with the resolution of dependant regulatory issues and strong execution of our plans with physician and other constituents, we have the opportunity to continue to grow BYETTA in the near…

Thank you, Orville. I’ll add a few comments before we close and take your questions. I would like to quickly preview the American Diabetes Association scientific meeting that will be held June 5, through June 9 in New Orleans. Once again, we’re planning to have a significant, scientific and commercial presence at that meeting. I’m pleased to announce that we have had more than 20 abstract accepted at the meeting. These studies reflect the breadth and depth of our scientific and clinical programs and the tremendous interest among the medical community for our novel approach to developing first-in-class medicine to address diabetes and obesity. Also several other studies have been submitted as late breakers. We have provided educational grants to support two medical education symposia and we’ll have a commercial exhibit where attendees can learn about Amylin, BYETTA and SYMLIN. Of particular note, please mark your calendars for a webcast of our annual investor reception on Sunday, June 7 at 7.45 pm Eastern Time to review meeting highlights. We look forward to see many of you in New Orleans. A preliminary list of abstracts and other activities at ADA will be posted shortly on our corporate website. Now also as many of you have seen, we recently announced our direct nominees for election at the 2009 annual meeting stockholders schedule for Wednesday May 27, 2009. Over the past several months, the company’s corporate governance committee, in close consultation with the independent directors, engaged in a through process to identify a slate of highly qualified and experienced nominees that the board strongly believes will best serve the interests of all Amylin shareholders. New nominees to the board are Paul Clark, former Chairman, Chief Executive Officer and President of Icos Corporation and Paulo Costa, former President and Chief Executive Officer of Novartis…

(Operator Instructions) Your first question comes from Thomas Wei - Piper Jaffray.

A couple of question on the thyroid cancer front; first just clarification, did you say the highest dose in the once weekly carcinogenicity study that you achieved, 30 times the human exposure; and then I also just wanted to check, have you actually had a chance to talk to the FDA about whether or not you have sufficient data for filling? It sounds like you don’t plan to wait for feedback from the FDA before filling the application and I’d like to understand why that might be.

Thanks for the question. You’re absolutely correct. Orville did make the remark that in the two year cost initiative study in rats, that the highest exposure that was used was approximately 30 times the human exposure. I would reiterate Orville’s point that we’re talking about rat data here and there has been no maternally thyroid cancer seen in the human studies, with exenatide once weekly state. With regards to your question regarding consultation with the FDA, we’ve had continuous consultation with the FDA as part of our development program four exenatide once weekly and we’ve received no indication from the agency at this point that there’s any additional toxicology data are required for our submission. I’ll ask Orville to comment about whether you have anything to add to that?

Just a thing that I would add is we also have been in dialogue with the agency about the fact that we are nearing the end of the completion of the application and the file in the near future, and the agency is informed and expecting to receive the application.

I guess just to clarify, have you actually talked to them since the Liraglutide panel and have you specifically asked about their comments on long acting formulation seeming to have a different thyroid simulation profile and you might need to do for LAR?

Thomas, we’ve had no response from the agency or no comment from the agency since the Liraglutide panel in that regard.

Your next question comes from Matt Osborne - Lazard Capital Markets.

[Audio Gap] that you’re compiling for Exenatide on the DURATION trials. Are you measure calcitonin levels at baseline and ultrasound also and CEA markers at baseline; if not you planned to do that in the Duration-5 trial?

Matt sorry, the first part of your question, I think was cut off. Could you just repeat what you said in the first part of your question?

Sure, are you measuring clinically with exenatide LAR or have you been measuring since baseline calcitonin levels or have you taken ultrasounds of the neck or measured CEA markers for clinical signal of thyroid cancer from baseline in any patient in the DURATION trials?

Yes, so the answer to that is that we haven’t been measuring calcitonin levels in the exenatide once weekly program. We recently initiated DURATION-5 study; we are measuring calcitonin levels from baseline and we’ll continue to do so. Again Orville, perhaps I don’t know is there’s any additional comment you have on that?

Well the comment that I would have is that we had no indication based on our data from the book-to-buy program and the exenatide once weekly program; that would indicate a need to measure calcitonin level. This has just become an issue that’s come to our attention, following the availability of the greeting materials for the Liraglutide Advisory Committee meeting.

Your next question comes from Cory Kasimov - J.P. Morgan.

Just one more on this LAR exenatide once weekly potentially thyroid signal here for this class. Has the FDA made any comments, I guess and/or request to you since you file that to your toxicology data last fall for exenatide once weekly; have they had anything to say about it?

Thanks for the question Cory; no, they haven’t.

Then going to pancreatitis for a second; you’ve done a good job explain or demonstrate the lack of the cause of the relationship, but can you characterize the extent of the pancreatitis overhang at this juncture in the marketplace or in the marketplace today. You had indicated in prior public comments that it seemed to be dissipating to a certain extent and I’m just wondering how much of an impairment it represents today?

Thanks Cory, it’s a great question. I’m going to ask Vince Mihalik to answer that question it seems closest to the market in the last few months.

So Cory, despite the FDA posting, we did spend the fourth quarter of last year focused on trying to answer a lot of questions around pancreatitis. We have now shifted our focus and released coordination, but really been spending our time returning back to focusing on the key messages that supports the unique profile BYETTA has, which of course is glucose control with a potential for weight loss, a low risk of hypoglycemia and favorable cardiovascular risk profile. Those messages have been resonating well. I think we’re seeing a bit of the economic downturn in the first quarter, but from our data you can see despite the economic downturn, we have stabilized BYETTA scripts.

Okay and then finally one last sort of housekeeping question. Mark had mentioned in his comments that there was slightly de-stocking that took place in the quarter; was that your opinion offset at all by the recent price increase you took or have you see no impact from that?

I’d say actually, I don’t think it was offset at all. This is actually the second quarter in a row that we’ve actually seen some de-stocking. What I think is going on here is, is that what we’re seeing is during this time of significant economic pressure, that you’re seeing wholesalers really managing their capital extremely tightly and what they’re doing is tightening up and so we’ve seen it now. Literally since last September, a couple of days each quarter has been timed up, almost a week now in terms of decreased stock taken from the distribution channel.

Your next question comes from Tom Russo - Robert W. Baird.

So, something you could comment a little bit more on the actual comparability results and if it takes a period of time for the clinical and the commercial material to kind of behave the same. As the FDA indicated that they’re okay with that or kind of how they’re going to look at the results as opposed to that the approach is acceptable and then I was also hoping you could comment on what regulatory submission’s DURATION-5 is required to support and where the additional data on the commercially manufactured product is intended to help out?

So, with regards to the comparability analyzes, firstly we’ve exceeded last year as we actually informed the investment community at the time we received the input from the agency of what they would be looking for in terms of the analytical undertaking with regards to demonstrating comparability. As Orville indicated on the call, we have completed those analyzes and we believe that we meet the criteria with regards to demonstrating comparability, and therefore we’re going forward with the submission. With regards to DURATION-5, DURATION-5 is being undertaken for a number of reasons. It would be also important for us in terms of being a second study to demonstrate superiority with regards BYETTA. Secondly, it does as you indicated, it does have a near final form of a commercial presentation in it being use and that will provide feedback from patients, which will enable us to provide better educational material at the time of launch. Then thirdly, as you also indicated in your question, it will be used to augment overseas submissions. I don’t have on the tip of my fingers the specific countries that it will be useful, but of course it also depends on the timing of the submissions, both submission diabetes.

I think I know the question was asked earlier about kind of reconfirming with FDA that the preclinical talks work that was done; have you had a chance dialog specifically on the results of the comparability, the DURATION-1 extension comparability data with the FDA?

We’ve just taken the guidance that they gave us and have completed the analysis, which we believe meets the criteria.

Okay and then last question and then I’ll step aside. Can you comment on whether the label updates or the discussions, they are including potential for class label for the tumor signal that got so much attention at the panel meeting a couple weeks back? Thanks.

So I think what I will do is I’ll ask Orville to comment on that question, because he was actually at the panel, but I would remind you that the panel was specifically around Liraglutide and it was not with any regard covering the toxicology program of any other GLP-1 receptor agonist. Orville, could you comment?

Just to remind you that for the label update we are talking about BYETTA, therefore the data set that’s relevant is the data from the BYETTA development program and that was the robust package that showed no issue in terms of the C-cell cancers and that’s the trust of the intension for labeling and the labeling update. Tom Russo - Robert W. Baird & Co.,: So at this point it would be unexpected for the new BYETTA label to address this as a class effect?

Absolutely would, in fact we are not aware of any conversations in that regard. Indeed I point to comments made by an FDA official following the panel, of which they stated specifically that they had looked at this issue with regards to the exenatide data that they had and have not seen any signal in this regard.

It’s also just important to remember here that exenatide is a different molecule from where liraglutide has a different chemical construct. It is not metabolized to any extent, then the body is filtered intact at the kidney and removed or eliminated from the body by the kidney in this contrasts with a much more complex metabolic pathway for liraglutide in the body.

Your next question comes from Craig Gordon - Frontside Research.

Just a couple of questions; are you guys are anticipating the SMBL monotherapy and the label revision for pancreatitis to still occur this quarter?

At this point we’re just saying that within the near future it’s very difficult to predict exactly what the timing will be with regards to that update. As Orville mentioned in his prepared remarks, we are pleased with the diligence with which the agency is reviewing and has been willing to receive additional data from us, in regards to this situation. At this point, we are not providing any specific guidance with regards the timing of when we may or may not receive the monotherapy indication and the label update from the FDA.

Another question about the comparability results, would we expect those to be presented ADA or are we’re going to have access anymore detail besides just that it met FDA requirements?

I think at this time there are no plans for the comparability data to be presented at the ADA. It would not really been a appropriate form frankly. As you’re looking at PK and looking at a comparability or manufacturing site, so the American Diabetes Association meeting would not be in a appropriate form for the presentation of that data. At this point, as I said earlier believe that we have met the criteria based on the agencies guidance to us and we intended to go forward on the basis of the analysis that we’ve undertaken today.

Then on the remaining ongoing DURATION trials and perhaps even in DURATION-2, are you able to go from the blood samples you guys have collected to look a calcitonin levels?

That’s a great question Craig. I’m afraid I don’t know the answer. I’m going to pass it over to Orville and see whether or not that’s possible to do it.

That’s an issue that is under active investigation following the liraglutide panel. There are a number of things that we’re looking at as to whether we should consider undertaking to provide additional clarity regarding that. One of the issues related to those samples is that calcitonin measurements were not included in the informed consents in those places. So if we do have adequate samples to make the measurements, we then have to look at the logistics of making sure that we are compliant with the patient confidentiality issues and the other informed consent issues.

Your next question comes from Jim Birchenough - Barclays Capital

Jim it’s a good question. Clearly first and foremost I think it’s really important to reinforce the fact that both exenatide and liraglutide are very different molecules. Chemically they’re extreme, they are different; they metabolized very differently and so of course one of the things that we will be doing is insuring that we highlight those differences in any correspondence that is undertaken. In terms of specific additional action, as Orville just indicated in responding to the previous question we are looking that whether there are other activities that we can undertake to provide greater confidence to the agency. That being said, we do believe that actually the profile is very different and our understanding is extremely different and it’s further supported by the fact that we do have already very significant clinical exposure to exenatide, from which we have never seen a clinical signal of C-cell thyroid cancer associated with the exenatide use. Orville, I don’t know if you want to add additional thoughts to that.

I would just remind everyone that with the registration of the exenatide once weekly, we’re pursuing a line extension strategy and that strategy is based upon consideration that the molecule has been qualified and so again I refer you back to the robust preclinical program that we had for BYETTA which I did not identify this issue as a problem with BYETTA, and that is a view that has been conformed by the agency and the comments following the reason advisory committee.

I guess just to follow-up on that, I guess what I am wondering is, do you have any intention to do some in vitro work looking at relative C-cell effects of Lira versus exenatide, that might be helpful for FDA, why not do that? I guess the other part the people are struggling about this and I’d interest in your comment; how do you maintain a line extension designation when FDA itself has distinguished between longer acting and shorter acting GLP-1 drugs with the thyroid cancer signal?

I guess a Jim a couple of things. Firstly, as I did say previously, we are trying to and are looking at a number of different things that we could undertake. At this point we haven’t decided on a specific plan going forward; however your comment with regards to looking at different in vitro studies is something that is being considered. The point would be that we have already conducted with the FDA our pre-NDA meeting with them and conformed with them that the registration strategy is a line extension strategy. I would point out that that the time of that pre-NDA meeting occurred, the agency within full position of the preclinical program of liraglutide. This finding was actually many years old and indeed so they will fully aware of that at the time they agreed to a line extension strategy designation and for application.

Okay thanks Dan, very helpful.

Well, thank you. At this point I will close the call and I want to say, again thank you for interest and your questions and finally finish by saying at Amylin, we do remain focus on our five point plan to maximize shareholder value and look forward to seeing many of you at our shareholder meeting and at the American Diabetes Association meeting New Orleans made to this year. Thank you.

We thank you for your participation in today’s conference. This does conclude your presentation. You may now disconnect. Have a great day.