Amylin Pharmaceuticals, Inc. Q3 2009 Earnings Call Transcript

Oct.20.09 | About: Bristol-Myers Squibb (BMY)

Amylin Pharmaceuticals, Inc. (AMLN) Q3 2009 Earnings Call October 20, 2009 5:00 PM ET


Michael York - Senior Director of Investor Relations

Daniel M. Bradbury - President, Chief Executive Officer, Director

Mark G. Foletta CPA - Chief Financial Officer

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


Mona Nilsson - J.P. Morgan

Jason Zhang - BMO Capital Markets

Thomas Russo - Robert W. Baird & Co.

Ryan - Robert W. Baird & Co.

Terence Flynn - Lazard Capital Markets


Good afternoon ladies and gentlemen my name is Stephanie and I will be your conference operator today. At this time I would like to welcome everyone to the Third Quarter 2009 Amylin Pharmaceuticals Inc. Earnings Conference Call. (Operator Instructions). I would now like to turn the conference over to your host for today Mr. Michael York, Senior Director of Finance and Investor Relations. Please proceed.

Michael York

Good afternoon and 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 release 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. Also, we have uploaded a presentation on our website that provides additional background on the quarter.

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. Earlier today we released our operating results for the quarter. We maintained stable revenue quarter-over-quarter while implementing our new commercial model we discussed on our last quarterly call. We are starting to see the benefit of the increased operating leverage and enhanced productivity that have resulted from the actions we have taken over the past year. Indeed this quarter the Company generated non-GAAP operating income.

This afternoon our comments will build on the press release issued earlier today.

n a few moments Mark will provide additional details on the quarters underlying financial results and comment on our outlook for the remainder of the year. Vince will then review our commercial activity for the quarter and highlight our plans for the future.

Before I turn the call over to Mark I will provide an update regarding third quarter performance with respect to the five priority areas to drive shareholder value that I outlined at the start of the year.

The first area of value creation is BYETTA. While we were building out the exenatide 1 team and deploying our specialty sales force during the third quarter we were able to maintain stable revenues relative to the second quarter of this year. Recall that exenatide 1 is a single integrated Amylin Lily business unit located in San Diego and our restructured sales team is designed to better address the needs of physicians who treat the significant number of patients with type 2 diabetes. From a regulatory perspective we have an application into the FDA for a monotherapy indication. We continue to have constructive dialogue with the agency and I remain confident that it will be approved in the near future.

The second area of value creation is exenatide once weekly. The review of this new drug application is ongoing and we remain confident in our submission.

In the third quarter the agency filed the submission, we received the 74-day letter, and we submitted the 120-day safety update. These activities are consistent with a standard review timeline. As a result of these actions we remain fully engaged in pre-launch activities with the expectation of a launch in 2010.

An important component of the launch strategy is the DURATION series of clinical studies which are progressing as planned. Additionally, we are pleased to announce today a new study DURATION-6. DURATION-6 will evaluate exenatide once weekly head to head with Liraglutide a GLP-1 analogue in development in the US and currently marketed in Europe.

As we have announced previously we are set to initiate a major cardiovascular outcome study by the end of the year. This study is designed to determine the extent to which exenatide once weekly may reduce the risk of cardiovascular events in people with type 2 diabetes.

The third area of value creation is SYMLIN. Consistent with our experience with BYETTA revenue is stable quarter-over-quarter as we implemented the new sales model. The new specialty sales model increases promotion of SYMLIN and we believe this will result in sales growth over the next few quarters.

The fourth area is our obesity program which remains on track. In the third quarter we announced positive top line Phase II data from pramlintide/metreleptin study. This study is continuing and data from the extension will be announced later this quarter. Additionally, we will report data from a Phase II study of our other obesity product candidate called davalintide. Based on the outcomes of these studies we will finalize a development and funding strategy by the end of the year.

The final area of value creation I highlighted at the beginning of the year is to improve financial performance with a goal of creating sustainable positive cash flow from operations by the end of 2010. This quarter we generated positive cash flow from operations, an achievement resulting from deliberate actions taken over the past 12 months to reshape our business and control expenses. These results put us on a solid trajectory towards achieving our 2010 goal. I would note that over the next few quarters we will make investments in preparation for a 2010 launch of exenatide once weekly leading to some variability in our quarterly financial results.

Before turning the call over to Mark I would like to mention our successful presence at the European Association for the Study of Diabetes conference in September. At this important global meeting we unveiled more than 20 studies reinforcing the safety and efficacy of BYETTA and SYMLIN and highlighting the promise of exenatide once weekly as a potentially transformational new treatment option for people with type 2 diabetes.

I will now turn the call over to Mark.

Mark Foletta

Thanks Dan, and good afternoon. I will provide an update on our third quarter results and financial guidance for the remainder of the year. As Dan mentioned and discussed in previous calls, we are managing the business aggressively, focused on generating sustainable, positive operating cash flow and maintaining a strong cash position. As I have discussed over the last several quarters, the key metric to track our financial progress is non-GAAP operating loss. We believe that this metric is an important measure of the performance of our business. Non-GAAP operating loss approximates our use of cash for operations before working capital changes as we drive towards our stated goal of sustainable, positive operating cash flow by the end of 2010.

As a reminder, non-GAAP operating loss is defined as our GAAP operating loss adjusted for non-cash items including equity compensation, depreciation and amortization, and any one time items such as restructuring charges.

We reported non-GAAP operating income of approximately $0.6 million this quarter. This compares to a non-GAAP operating loss of $32.7 million for the same period in 2008. Total revenue was $211.2 million including net product sales of $192.9 million in the third quarter, compared to total revenue of $218.4 million including net product sales of $201.4 million for the same period in 2008.

Product sales in the third quarter were $171.1 million for BYETTA and $21.8 million for SYMLIN. BYETTA sales were down $4 million compared to last quarter due to a modest increase in wholesaler inventories last quarter. Wholesaler inventories at September 30 were comparable to those at June 30. Excluding the impact of stocking on second quarter sales BYETTA product sales were comparable quarter-over-quarter and in line with stable prescription levels in the third quarter.

Cost of goods sold was $22.6 million reflecting a gross margin of 88%, consistent with gross margins in 2008.

Selling, general and administrative expenses decreased to $80.1 million compared to $99.7 million for the same period in 2008. The decrease is primarily attributable to lower sales force and business infrastructure expenses driven by our reduced cost structure.

Research and development expenses decreased to $52.7 million compared to $73.5 million for the same period in 2008. The decrease is primarily due to lower development expenses for exenatide once weekly following the recent completion of the DURATION-2 and 3 studies and lower expenses for our obesity program following completion of the pramlintide/metreleptin Phase II clinical study. The decrease in research and development expenses also reflects additional efficiencies driven by our reduced cost structure.

Net loss for the third quarter was $26.7 million or $0.19 per share compared to a net loss of $79 million or $0.58 per share for the same period in 2008. At quarter end we held approximately $620 million of cash and investments.

I will now review top and bottom line results for the nine months ended September 30, 2009.

Total revenue for the first nine months of 2009 was $614.3 million including net product sales of $569.7 million. This includes BYETTA sales of $503.9 million and SYMLIN sales of $65.8 million. This compares to total revenue for the first 9 months of 2008 of $637.6 million including net product sales of $580.4 million consisting of $515.9 million for BYETTA and $64.5 million for SYMLIN.

Our reported net loss for the first nine months of 2009 was $136 million or $0.97 per share compared to $216.7 million or $1.58 per share for the same period in 2008. Most importantly our measure for operating cash flows non-GAAP operating loss was $41.7 million for the first nine months of 2009, a 64% improvement over the $117 million non-GAAP operating loss recorded for the same period last year.

I would now like to review and update previous financial guidance.

We now expect our non-GAAP operating loss to be between $60 and $70 million in 2009. This has improved from the lower end of the range of $75 to $100 million we guided last quarter. The improvement primarily reflects continued savings from the changes to our operating model over the past year. This revised guidance implies planned investments in the fourth quarter to support the launch of exenatide once weekly in 2010. I will discuss updates to our GAAP guidance in a moment.

Non-cash expenses projected for 2009 are unchanged at approximately $100 million and consist of $60 to $65 million of stock based compensation from stock options and our employee stock ownership plan and approximately $35 to $40 million of depreciation and amortization. Consistent with the reduction in our expected non-GAAP operating loss we now anticipate our GAAP operating loss for 2009 will be $160 to $170 million.

To assist you in understanding the rest of our income statement I will provide some additional information.

We expect collaborative revenue in 2008 to be $65 to $70 million and will consist primarily of cost sharing payments from Lily for their share of exenatide development.

We expect that our gross margins for the remainder of 2009 will be comparable to the 88% margins we have realized for the first nine months of the year.

We now expect that our total GAAP operating expenses comprised of selling, general and administrative expenses will be at the low end of our previous range of $600 to $625 million. This is a reduction from our previous guidance of the mid-point of this range. We believe that selling, general and administrative expenses for the fourth quarter will increase modestly from our third quarter run rate due to investments in exenatide once weekly pre-launch activities.

We also expect that research and development expenses will increase from our third quarter run rate driven largely by investments in exenatide once weekly to support the planned 2010 launch. These investments include pre-launch manufacturing activities and the initiation of a cardiovascular outcome study in the fourth quarter.

We continue to expect that net interest expense will be $15 to $20 million for 2009.

To finish up on the cash flow front we offer the following additional guidance: We expect capital expenditures net of reimbursements from Lily for their share of the capital investments for the exenatide once weekly pen device to be approximately $100 million in 2009, lower than our previous guidance of $125 million, and greatly reduced from approximately $300 million of capital spending in 2008.

Maturities of our long-term secured debt will result in payments of approximately $30 million of which $23 million was paid in the first nine months of the year.

We are continuing to pursue options to offset the research and development expense associated with our obesity and early stage programs.

The cumulative impact of this guidance suggests that we expect to finish 2009 with a substantial cash balance of approximately $550 to $575 million with access to an additional $165 million from the Lily credit facility.

To summarize, we are pleased with our solid financial performance in the third quarter which reflects substantial changes to our operating model, bringing expenses in line with current revenues. I would note our marketed products continue to generate positive and improving contributions to the business.

As Dan mentioned earlier, although we generated positive cash flow from operations this quarter, we expect some variability in our non-GAAP operating results over the next few quarters as a result of investments in manufacturing activities and market development to ensure a successful launch for exenatide once weekly. With this in mind, I want to reaffirm our commitment to achieving positive operating cash flow on a sustainable basis by the end of next year.

Now I will turn the call over to Vince to review our commercial activities.

Vince Mihalik

Thank you, Mark. Amylin sales and marketing organization remains focused on our day-to-day business driving 2009 revenue and advancing our longer-term commercial strategy: our third quarter results reflect this focus.

I will start my remarks discussing some operational advances before diving into progress by product.

Last quarter I highlighted that we merged Amylin’s existing primary care and specialty sales forces into a single sales organization that would bring a more highly trained specialty approach to endocrinologists and diabetes focused primary care physicians.

As a reminder, our specialty field sales organization now includes approximately 325 sales representatives focused on endocrinologists and other physicians who treat significant numbers of diabetes patients. I am pleased to report that the changes to our sales force are fully implemented. Over the course of the third quarter we observed an improvement in sales effectiveness as our specialty representatives worked their way through new territories and target lists. We strongly believe that a substantial amount of new training for our sales representatives, which they received in the third quarter, has transformed our sales force. We are committed to this intensive training for our field teams that will position them as a valuable resource to help physicians better achieve outcomes for their patients with type 2 diabetes.

Additionally, our exenatide-1 business unit is in place and focused on growing BYETTA as preparations for the launch of exenatide once weekly continue.

Now I will provide brief updates on in-line products starting with BYETTA.

As a reminder, BYETTA is the first and only FDA approved GLP-1 receptor agonist available on the market. BYETTA occupies a unique place in the treatment of type 2 diabetes by addressing specific unmet needs with the dual benefits of powerful glucose control with potential weight loss supported by a low risk of hypoglycemia. Even with the restructuring of the sales force and the roll out of the exenatide-1 business unit sales were stable quarter-over-quarter while total prescriptions of BYETTA were comparable to the second quarter of 2009. These results are consistent with our expectations regarding the impact of the reorganization.

This month also marks an important milestone for BYETTA. I am pleased do announce that based on current prescription trends we project that the 10th million prescription for BYETTA will be written by months end. This accomplishment speaks to the rich heritage of BYETTA in the marketplace and the ongoing confidence physicians and patients have in the brand. We continue to build up this vast clinical experience with exenatide and educate the market on the dual challenges of poor glycemic control and excess body weight. The unique clinical profile of BYETTA, well described improvements in glycemic control coupled with positive effects on body weight positions it as a compelling option to address these challenges. Our goal is to help the market better understand the benefit of treating patients with BYETTA to control their glucose while having a positive impact on weight.

It is well established that weight gain contributes to the manifestation and progression of insulin resistance and even modest amounts of weight loss can benefit the short-term and long-term health of type 2 diabetes patients.

To close my comments on BYETTA I will briefly touch upon access. In spite of the pressure on the managed care plans to reduce costs we maintained 85% cured, to access for BYETTA. We continue to remind patients and physicians of this broad access.

Now let’s move onto SYMLIN the first and only FDA approved Amylin analogue. It is our wholly owned compound that addresses unmet needs for patients with type 1 and type 2 diabetes who use mealtime insulin. SYMLIN reduces blood glucose fluctuations, improving glucose control and often causing weight loss. Revenue was stable quarter-over-quarter despite the reorganization of our sales model. SYMLIN Pen, which now represents 75% of all new SYMLIN prescriptions, grew 4.1% in Q3 2009 compared to Q2 2009. Additionally, we believe that our sales specialty model, enhanced training on SYMLIN and the increased promotional efforts supporting SYMLIN, we will grow this product over the next few quarters.

Turning to exenatide once weekly, the exenatide team is continuing in full pre-launch mode and is actively preparing to commercialize exenatide once weekly in 2010. The DURATION series of studies is progressing as planned. We call that these studies are designed to demonstrate superior glucose control compared with leading medicines widely used to treat type 2 diabetes with regards to overall glucose control. To date DURATION-1, 2 and 3 have provided exciting results demonstrating compelling efficacy with exenatide once weekly against Actose, Januvia, Lantus and BYETTA. These results are clear. Exenatide once weekly is positioned to be a transformational medicine in the treatment of type 2 diabetes.

Data from DURATION-4 and DURATION-5 are expected next year. Additionally, as Dan mentioned in his opening remarks, we are initiating DURATION-6 as a study this quarter. DURATION-6 will examine the efficacy, safety and tolerability of exenatide once weekly head-to-head with Liraglutide a GLP-1 analogue in development in the US and currently marketed in Europe. Based on positive trends in the markers of cardiovascular health reported with BYETTA and in the DURATION program we are initiating a cardiovascular outcomes clinical trial later this quarter. This study is designed to determine the extent to which exenatide once weekly may reduce the risk of cardiovascular events in people with type 2 diabetes.

Let me close my portion of the remarks by saying that we are encouraged by the momentum we are seeing within our company, in our work with the exenatide-1 team, and in the marketplace. We believe we have transitioned to a commercial model that is more effective, efficient, and customer focused to provide value. Even as we plan for the launch of exenatide once weekly our organization remains dedicated to driving near-term performance for BYETTA and SYMLIN.

I will now turn the call back over to Dan to discuss additional activities.

Dan Bradbury

Thanks, Vince. I will add just a few more updates before we close. As I mentioned earlier our obesity program represents the fourth area focus in our plan for value creation for Amylin in 2009. During the third quarter we announced positive results from a 28-week dose ranging study of the combination therapy pramlintide/metreleptin to treat overweight and obese patients. This Phase II study successfully characterized patients who responded best to treatment and also provided important information to informed dose selection. By the end of this year we will report data from the extension to this study.

In our other clinical program focused on obesity we remain on track to complete the davalintide

Phase II study later this quarter. We will finalize our obesity development and funding strategy based on the outcomes of these studies.

Also during the quarter we entered into an agreement with Biocon to jointly develop, manufacture and commercialize the novel peptide therapeutic for the potential treatment of diabetes. The technology at the center of this agreement is our peptide hybrid or fybrid technology which enables the fusion of two different peptides with unique attributes or synergies. Fybrids encompass dual pharmacology in a single molecular entity and provides the benefits of less complicated manufacturing in clinical development programs. I am exited about this agreement because enables us to access Biocon’s world class manufacturing expertise and move the program forward in an expeditious manner.

Amylin and Biocon will collaborate the therapeutic potential of this fybrid compound and share development costs. This is consistent with our strategy to pursue options that enable advancement of our early stage programs while sharing technical and financial risks.

Also during the quarter our Board of Directors elected Paulo Costa as Chairman. Paulo is the former President and Chief Executive Officer of Novartis US Corporation and he brings significant operational and commercial expertise to the Company.

Now to close, as I noted at the start of the call we are aggressively executing our business plan and remained focused on those five key areas of value creation that I have outlined at the beginning of this year. Consistent with this plan we continue to focus on executing with urgency in order to: 1. Gain FDA approval for BYETTA use as monotherapy in type 2 diabetes and finalize the label update. 2. Grow BYETTA and SYMLIN revenue. 3. Advance our pre-launch activities for exenatide once weekly. 4. Progress the obesity program and finalize our development and funding strategies. 5. Continue to manage our expense and drive towards sustainable positive cash flow from operations.

I want to underscore that through the changes we have made over the last 12 months to our business we continue to deliver improved results and build operating leverage into our business model. We have tremendous momentum heading into the close of the year and we will continue to focus on executing our business plan and advancing our mission to improve the lives of people with diabetes.

I will now ask the operator to open the lines for questions.

Question-and-Answer Session


(Operator Instructions) Your first question comes from Cory Kasimov from J.P. Morgan.

Mona Nilsson - J.P. Morgan

This is actually Mona for Cory. My first question is actually on the 120-day safety update. I was wondering if you are in a position to share the data from how many patients in the DURATION studies were actually included in that update?

Dan Bradbury

I am not in a position to share that information. Just to say that the 120-day update was consistent with the FDA regulations around their requirement for 120-days which is all of those patients that would be completed within the period of time according to the regulation which is a number of months prior to that date.

Mona Nilsson - J.P. Morgan

Okay and then I realize the data from the DURATION-4 and 5 studies are going to be available in 2010, but are you in a position to put a refined timing on that?

Dan Bradbury

At this time we are not providing any more specific guidance on DURATION-4 and 5 with the exception of 5 which we are expecting in the first half of 2010.

Mona Nilsson - J.P. Morgan

Okay, thanks very much.


Your next question comes from Jason Zhang of BMO Capital Markets.

Jason Zhang - BMO Capital Markets

I jumped in a little late and I am wondering how much you have talked about your – you submitted the 120-day safety update and you also announced a cardiovascular trial for exenatide. Do you envision using that as a fulfillment for the cardiovascular requirements? I mean how has that trial played out in this whole process? Do you plan that trial primarily for actually showing the cardiovascular benefit or you might actually use that trial as a fulfillment for the cardiovascular risk mitigation before the potential approval?

Dan Bradbury

That is a great question. The cardiovascular outcome study has been specifically designed to demonstrate superiority relative to other diabetes therapies in showing an improvement in outcomes with respect to cardiovascular events. It is not being designed with a view towards answering the regulatory requirement. We announced previously, earlier this year, the analysis that we had done on the entire exenatide database demonstrating that there was no increase in cardiovascular risk associated with exenatide therapy; that analysis was updated as part of the 120-day update. Consistent with the agency’s request in our 74-day letter to do a combined analysis looking at all exenatide therapy, which is both BYETTA and exenatide once weekly, as part of the assessment of cardiovascular risk.

Jason Zhang - BMO Capital Markets

On the capital expenditure you just mentioned you are lowering your guidance for this year from previously $125 to $100 to develop the pen for exenatide. Have you updated your timeline for that program? Are we supposed to see that program complete by 2012 or is that your end place?

Mark Foletta

I think you should think of the adjustment of the capital guidance in 2009 as just the timing of cash flows. The program remains on track with really no change in the timeline of when we expect to have the pen available.

Jason Zhang - BMO Capital Markets

That is originally planned to be completed by 2012, right?

Dan Bradbury

Our guidance actually specifically was within two years of the launch of exenatide once weekly which would be consistent with what you are saying if EQW is approved next year.

Jason Zhang - BMO Capital Markets

Okay thanks.


Your next question comes from Thomas Russo of Robert W. Baird & Co.

Ryan - Robert W. Baird & Co.

This is actually Ryan for Tom. I have a question about the status of the label updates. Can you specify what external to Amylin is factoring into that and whether the critical path is currently going through the agencies review of other GLP-1s?

Dan Bradbury

We have continued to have constructive dialogue with the agency and the agency continues to be open to the receipt of information from us. In terms of the timeline and what is taking such a length of time, I really cannot speculate with regards to the agency’s workload and what may be affecting that. All I can say is that I would reiterate that we remain confident that the indication will be approved for monotherapy and that we expect to see the label update in the near future.

Ryan - Robert W. Baird & Co.

Okay and then just a follow up, as part of the 120-day update can you share any interactions you have had regarding the sufficiency of the animal toxin carcinogenicity data that you provided and what if anything you are looking for in addition?

Dan Bradbury

With regards to the 120-day safety update as we reported on the last earnings call the requirements for the 120-day safety update were actually specified in the day 74 letter that we got. That letter was consistent with our expectations. They did not ask us for any additional pre-clinical or clinical studies during that letter. The 12-day update requests were consistent with the line extension strategy and the agency indicated at that time that the PDUFA date would be in the first quarter of 2010.

With regards to additional interactions with the agency, at this time I cannot comment on any additional interactions except to say that all of the interactions that we are continuing to have with the agency are consistent with the agency continuing the review according to the PDUFA timeline.

Ryan - Robert W. Baird & Co.

Okay thanks.


Your last question comes from Terence Flynn of Lazard Capital Markets.

Terence Flynn - Lazard Capital Markets

I was just wondering if you could provide us any more details on the design of the DURATION-6 trial with regards to is it going to be a non-inferiority or superiority design. Also, the geography of the trial, is it going to be an x-US study or is it going to be a worldwide trial?

Dan Bradbury

As you know DURATION-6 is the latest in the DURATION superiority study series so specifically this study is designed to demonstrate superiority of exenatide once weekly head-to- head with Liraglutide in regards to glucose control. This study will be conducted in multiple sites across the globe, so I can’t give you too many details on that, but to say that our expectation is that it will be approximately around 900 patients will be involved in the study design.

We believe that with the efficacy that we have seen in the DURATION program to date that we have a great opportunity here to demonstrate the superiority of exenatide once weekly with regards to Liraglutide and we are very excited about the potential outcome for this study.

Terence Flynn - Lazard Capital Markets

Okay, thanks a lot.


I would now like to turn the call over to Mr. Dan Bradbury, President, and CEO for closing remarks. Please proceed.

Dan Bradbury

I would like to thank everybody for their interest and for the questions that we have received today. As I mentioned in my closing remarks in the pre-prepared remarks, we do have a great opportunity, I believe, going forward to continue to advance our mission in the fourth quarter of this year of discovering and developing and commercializing medicines that improve the lives of people with diabetes.

I would also like to reiterate the fact that our leadership team and the dedicated employees of Amylin remain focused both on building the business today, as well as laying the necessary foundation for success tomorrow.

If any of you have any additional questions following the call please call Michael York, our head of our Investor Relations Team. Thank you very much.


Ladies and gentlemen that does conclude the conference call for today. We thank you for your participation. (Operator Instructions)

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