Amgen Inc.

Amgen Inc.

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Amgen Inc. (AMGN) Q4 2012 Earnings Call Transcript

Published at 2013-01-23 19:07:05
Executives
Arvind Sood – VP of IR Bob Bradway – CEO, President, COO Jon Peacock – CFO, EVP Tony Hooper – EVP of Global Commercial Operations Sean Harper – EVP of Research & Development
Analysts
Robyn Karnauskas – Deutsche Bank Robby Winarta – Credit Suisse Matt Roden – UBS Michael Yee – RBC Capital Markets Geoffrey Porges – Bernstein Chris Raymond - Robert W. Baird Marshall Urist – Morgan Stanley Eric Schmidt – Cowen and Company Eun Yang – Jefferies Geoffrey Meacham - JPMorgan Chase Yaron Werber – Citi Mark Schoenebaum – ISI Group Josh Schimmer – Lazard Capital Markets Rachel McMinn – Bank of America Merrill Lynch Terence Flynn - Goldman Sachs Joel Sendek – Stifel Nicolaus Tony Butler - Barclays Capital
Operator
My name is (Marvin) and I will be your conference facilitator today for Amgen’s fourth quarter and full-year 2012 financial results conference call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speaker’s prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. (Operator Instructions) I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.
Arvind Sood
Thank you, (Marvin). Good afternoon, everybody. I would like to welcome you to our conference call. The focus of our call today will be to primarily discuss our strong operating performance during the fourth quarter and full-year 2012. This performance is increasingly backed by diverse portfolio products. In addition to our strong operating performance, 2012 was characterized by meaningful advances within our pipeline, completion of important acquisitions and return of significant capital to shareholders. To discuss these topics in greater detail, I’m joined by several members of our leadership team. Our Chairman and CEO, Bob Bradway, will begin with a brief strategic overview. Following Bob, our CFO, Jon Peacock, will review our quarterly results and provide revenue and EPS guidance for 2013. Our Head of Global Commercial Operations, Tony Hooper, will then highlight our product performance followed by our Head of (Warranty), Sean Harper, who will provide a brief pipeline update. The reason I said brief is because we will host our business review meeting in New York on February 7th. At this meeting, we’ll discuss several initiatives and strategies in detail, notably our pipeline, which will be critical towards driving our long-term growth. We’ll use slides for our presentation today. These slides have been posted on our website and a link was sent to you separately by email. Our comments today will be governed by our Safe Harbor statement, which in summary says that through the course of our presentation today, we may make certain forward-looking statements and actual results could vary materially. So with that, I would like to turn the call over to Bob.
Jonathan Peacock
Our strong cash flow performance was driven not only by the strong underlying performance of the business but also by significant improvement in collection of trade receivables moist notably in Southern Europe and by cash received from unwinding some historic fixed to floating interest rate swaps. Uses of cash during the year (were) acquisitions which totaled $2.4 billion, dividends totaling $1.1 billion and share repurchases which totaled $4.7 billion. By year-end we had largely completed our $10 billion share repurchase program at an average cost of $66.30 per share. Over the next few years, our share repurchase activity will moderate and our focus will be more on continuing to deliver meaningful increases to the dividend. As you know, we’ve increased the dividend for 2013 by 31% to $0.47 a share. The board of Amgen has authorized a further $2 billion share repurchase program which we expect will carry us well into 2014. At the end of the year, we held $24.1 billion in cash and short-term investments and $26.5 billion in debt. The debt has an average maturity of 13 years and a fixed average pre-tax coupon of 3.8%. The balance includes a $2.5 billion convertible which matures in February and which we intend to settle in cash. We’re not planning to raise any additional debt in 2013 and I expect us back in a net cash position during this year. So just stepping back for a second, compared to the beginning of 2011, each Amgen shareholder now owns 23% more of the company and receives a dividend that we’ve increased by an average of 30% in each of the last two years. Let me turn now to guidance for 2013 on Page 7. We expect total revenues to be between $17.8 billion and $18.2 billion, a growth rate of between 3% and 5%. We expect adjusted earnings per share to fall between $6.85 and $7.15, a growth rate of between 5% and 10%. Our adjusted tax rate is expected to be between 14% and 15%. And if you include the Puerto Rico excise taxes that are carried in cost of sales and that you’ll see in the press release, the total tax burden is expected to be between 17% and 18%. And capital expenditures are expected to be approximately $700 million. Finally, in 2011, we issued 2015 guidance and we projected 2015 revenues in the range of $16 billion to $18 billion and adjusted earnings per share in the range of $7.25 to $8.60. Since then, the performance of the business has accelerated. We’re on track to hit the upper end of our 2015 revenue guidance two years early and we expect to be comfortably within our 2015 guidance on adjusted earnings per share at least one year early. As for 2015, we’re on track to deliver at least the upper end of our guidance on revenues and at least $8 in adjusted earnings per share. Going forward, our focus will be on initiatives and strategies to drive longer term growth beyond 2015 and you’ll hear more about that at our business review on February 7th. Let me turn now to Tony.
Tony Hooper
Thanks, Jon. So we delivered strong performance in 2012 despite increased competition, intensified macroeconomic pressures and access and reimbursement challenges. Our product sales grew 9% for the full year and 11% for the fourth quarter. Our commercial team remains focused to navigate the changing environment, build the right strategies and execute them as we embark on 2013. I look forward to discussing these challenges and opportunities with you in greater detail at our upcoming business review on February 7th. Let me now review our product performance for the fourth quarter, which is shown on Slide number 8. Starting with Neulasta and NEUPOGEN, I’d ask you to remember that Neulasta represents about 80% of the full graphic in sales. Sales declined 1% globally on a year-over-year basis but let me speak to the sequential trends for a moment. NEUPOGEN sales were flat as compared to the third quarter and Neulasta sales were down 5% driven by a 3% decline in unit demand.
Sean Harper
Thanks, Tony. Good afternoon. As most of you know, I’ll be reviewing our R&D strategy and giving an update on the pipeline at our February business review, so my comments today will be relatively brief. Our clinical programs are progressing well. We’ve initiated our Phase III program with the AMG 145, our PCS (K9) inhibitor for hypocholesterolemia. We recently reinitiated our study of Trebananib or AMG 386, our (inaudible) in recurrent ovarian cancer in the context of DOXIL now that supply issues for this chemotherapy litigation have eased. This study will complement our ongoing registrational program in ovarian cancer. If you will recall, earlier this month we announced the results of the Aranesp, RED-HF cardiovascular outcome study in patients with heart failure. This study was initiated back in 2006 and pursued (technical difficulty) target hemoglobin of 13, much higher than today’s therapeutic practices in establish indications such as renal disease or oncology. The topline results demonstrated no benefit on the primary endpoint of the study and no new safety findings were identified. It is important to recognize that anemic heart failure patients are not currently treated with DSAs as standard care. We completed our acquisition of deCODE Genetics at the end of December and we continue to be very excited about taking an industry-leading position in the use of human genetics to discover and validate our drug targets. I’ll discuss how this fits into our broader R&D strategy at the business review. Finally, we had a very productive 2012 in R&D and I’d like to thank all of the Amgen staff who made this possible. Bob?
Bob Bradway
Let me turn now to questions and answers. Why don’t we review the procedures for the Q&A?
Arvind Sood
(Marvin), would you go ahead and open it up for Q&A please?
Operator
(Operator Instructions) Your first question comes from the line of Robyn Karnauskas – Deutsche Bank. Robyn Karnauskas – Deutsche Bank: I guess my first question just comes along the – there’s been some talk around the bundle and maybe how the bundle rate might change given the new fiscal cliff law. Maybe you could talk a little bit about what you factored into your guidance and how you’re thinking about that.
Bob Bradway
I think there are a couple of things in there, one related to ESAs and then it sounds like you’re asking also about Sensipar. Tony, why don’t you address Robyn’s questions?
Tony Hooper
So while the (SBO) estimates that provisions to the SRD bundle payment system could save about $4.9 billion over 10 years but legislation of course does not explicitly direct (CMS) to remove the $4.9 billion from the payment system. Importantly, (CMS) is allowed the opportunity to conduct their own analysis and the legislation then directs (CMS) to use the most recently available data on average sales prices and changes in prices for drugs and biologics when the agency refaces the ESR (DPPS). I’d remind you that (AP) levels have been reduced to about ($10.7) and we’ve seen it stabilize at this level for the past few quarters and we do believe that further reductions would increase the number of transfusions. As regards to Sensipar, we do not believe that the current treatment patterns with Sensipar will be impacted by the delays of (inaudible). We will have and continue to encourage the appropriate use of Sensipar.
Operator
Your next question comes from the line of Robby Winarta – Credit Suisse. Robby Winarta – Credit Suisse: If I triangulate some of the numbers you’ve given on the buyback and the div and your at least 60% return, it looks like you’re implying a further increase in dividend this year that’ll get you to roughly 50% dividend, 50% buyback. Can you give us some more color on where you see that proportion of dividend versus buyback going beyond 2013 and where you see at least 60% of return going?
Jon Peacock
Yes, I think, Robby, I’ll talk in more detail about that when we come to the February 7th review. I think the focus – two things I’d remind you of, one is we’ve said that we would return on average at least 60% of net income to shareholders and we’re certainly well on track to doing that. And what I’ve said as going forward now we’ve completed the $10 billion share repurchase program, the focus will shift more to continuing to deliver meaningful increases in the dividend and I’ll elaborate more on that when we get to February 7th.
Operator
Your next question comes from the line of Matt Roden – UBS. Matt Roden – UBS:
Operator
Michael Yee – RBC Capital Markets:
Operator
Geoffrey Porges - Bernstein:
Operator
Chris Raymond - Robert W. Baird:
Tony Hooper
So as I said earlier, in the EPO market, we’ve really seen a stabilization of dose with hemoglobins stabilizing around ($10.7). So we haven’t seen any dramatic changes in either dose or size of the market for some time now. The 2% sequential decline in the fourth quarter was fundamentally all around competition but, as I said, we exited the year still in excess of 96% market share, so we continue to believe that the (inaudible) see the true value and benefit of EPOGEN based on this long history in the marketplace around both efficacy and safety. Aranesp as well, as you know, probably 65% of our business is outside the US. But, again, that continues to be fairly stable in terms of quarter-by-quarter performance with some competition coming from the side. But the actual market in terms of usage or dosage appears to be fairly stable.
Operator
Your next question comes from the line of Marshall Urist – Morgan Stanley. Marshall Urist – Morgan Stanley: So my question is just specifically on the 2013 revenue guidance. Could you guys just comment specifically on what your assumption is in the 2013 guidance about competition in the – for EPOGEN in the US dialysis market and how that’s reflected in your estimates? And then similar question on XGEVA, how you guys think a generic (Zomeda) is going to impact the market, if at all, and if there’s any conservatism around that that’s built into the 2013 outlook.
Bob Bradway
We’re not going to talk about specific product revenue guidance but why don’t we address your questions, again, about EPO and we can talk a little bit about XGEVA as well and the competitive dynamics that we see there. So Tony?
Tony Hooper
So the market going forward fundamentally has a (inaudible) as a competitor and we have not predicted any dramatic changes in the makeup of the market. Obviously we take every competitor seriously. We have long-term conflict with (Aveda). We have non-exclusive conflict with (Frasinius) in the marketplace and we have a highly experienced team out there every day talking about the benefit and the longer-term experience of EPOGEN. Let’s move into XGEVA and as we approach the patent expiry for the (subchronic) acid, we expect there will be some temporary disruption in the marketplace both as a result of competitive activities and some reimbursement considerations. But we continue to be very confident on XGEVA’s superior clinical profile and the benefit that it actually delivers to patients.
Operator
Your next question comes from the line of Eric Schmidt – Cowen and Company. Eric Schmidt – Cowen and Company: It’s for Jonathan on the Enbrel co-promote profits. It looks like you’ve paid out just under $1.5 billion in 2012 but I think your guidance is only to see about an $800 million benefit in 2014. I know you have (inaudible) declining royalty to Phizer but there must be something else that I’m missing in that equation.
Jon Peacock
No, it’s essentially the profit share falls away. We pay the royalty stream which declines over a three-year period and we would expect the net benefit to be about $800 million in terms of operating profits. Next year, we’re happy after the call to take you through the specifics of that if there is some gap in how you’re looking at it but those are the two components.
Arvind Sood
Eric, I can give you a call after this conference call and run through additional details if you would like.
Operator
Your next question comes from the line of Eun Yang – Jefferies. Eun Yang – Jefferies: I want to ask you one earlier (program) in Amgen’s pipeline 319. There is a fair amount of excitement in the (inaudible) class, so I want to get Amgen’s view on the target and also it seems to me that it’s a competitive field with a number of (PA3) (inaudible) perhaps in development. So how does Amgen see the advantage with the 319 and development plan?
Operator
Geoffrey Meacham - JPMorgan Chase:
Operator
Yaron Werber - Citi:
Operator
Mark Schoenebaum – ISI Group: I was wondering if you guys could tell us whether or not you’re planning on giving a new five-year financial target at your analyst meeting the way you did at the 2010 analyst meeting. And then also related to the guidance, if I – do I understand your comments about 2013 through 2015? It sounds like, the skinny, we shouldn’t be expecting much revenue growth based on those comments, 2013 to 2015, or should we really just be thinking about those as floors?
Bob Bradway
With respect to the meeting in February, I think it’s unlikely that we’re going to give a new set of five-year revenue and earnings targets the way we did when we were together with you in April of 2011. I think in April of 2011, we and the street consensus were in very different places with respect to the outlook for our business. So when we get together in February, we’re really going to concentrate on what we see as the long-term growth opportunities for the company, so we’ll focus on our strategy and how we think that will enable us to grow, so the international expansion plans, of course, our plans with biosimilars will have an opportunity for the first time to describe for you more fully the molecules that we’re planning to advance and the timeline against which we think we can advance them. We’ll talk, of course, about the pipeline in great detail and the molecules that are emerging from the pipeline that we think can drive growth. And so we’ll talk about the competitive profile as well that’s emerging for in line commercial products and go through that and what we hope will be useful depth so you can have a sense for why we remain excited about the long-term growth potential for the company. But with respect to the specific guidance for this year, Jon, why don’t you go ahead and add any other comments.
Jon Peacock
I think to be clear, what I said was that for 2015 we expect revenues to be at least at the upper end of that $16 billion to $18 billion range and to be at least $8 a share. So I think we have positioned those as floors and business will progress and we’ll work against those floors over the next couple of years.
Operator
Your next question comes from the line of Josh Schimmer – Lazard Capital Markets. Josh Schimmer – Lazard Capital Markets: Just curious as to the rationale for letting the net cash position improve. Do you not feel like you’ve got sufficient flexibility on the balance sheet the way it stand now? You can talk about that strategy.
Jon Peacock
I think we laid out clearly our plans to return at least 60% of net income to shareholders and retain the strategic flexibility to continue to make the kinds of acquisitions that you’ve seen over the last couple of years. So for the first time, this – the second half of this year we were in a small net debt position and over the course of 2013 we’ll be in a small net cash position, so it’s not a significant shift in the capital structure and our focus is to try to keep it on the sheet relatively efficient but keep sufficient strategic flexibility and we’ll continue to keep that under review. Josh Schimmer – Lazard Capital Markets: Is deCODE a type of deal that we should expect more of?
Bob Bradway
We’re obviously excited about the deCODE deal, Josh. That wasn’t the only transaction we did last year, as you know. We’re also excited about the acquisition of Micromet, which brought a very malleable piece of biology to treat grievous disease, in particular, leukemia and we hope lymphoma and perhaps all tumors as well. So we’re very excited about what that transaction did for us earlier in the year. We think the KAI transaction, as well, enables us to bring forward an innovative molecule that we can add value to in our pipeline, so another opportunity for us to grow. And of course, international expansion was part of our acquisition game in 2012. And I think each of those are the kinds of transactions that we’ll continue to look to do in 2013. So in addition, to the extent that we have an opportunity to acquire molecules that are either on the market or soon to be on the market where we think we can add value, we’ll look at those as well.
Operator
Your next question comes from the line of Rachel McMinn – Bank of America Merrill Lynch. Rachel McMinn – Bank of America Merrill Lynch: Just a question on the $18 billion floor guidance for 2015; does that assume impact from any pipeline products or is that just straight organic growth from currently marketed products? And then just to follow up on the share repo question, I guess I just wanted to clarify whether your EPS guidance actually assumes share repurchase in there because some companies like Celgene, for example, give us EPS guidance assuming no share repurchases.
Robert Bradway
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Anthony Hooper
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces. Rachel L. McMinn - BofA Merrill Lynch: We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Robert Bradway
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Operator
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces. Terence Flynn - Goldman Sachs: We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Anthony Hooper
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Robert Bradway
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Sean Harper
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Operator
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces. Joel Sendek – Stifel Nicolaus: We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Anthony Hooper
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Operator
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces. Tony Butler - Barclays Capital: We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Sean Harper
We were seeking really an industrial platform to become the industry leader in using human genetics for target identification and validation, and they were really seeking a way to see the enormous way of discoveries that they are engaged in right now translate into impact on patients and through the development of new medicines and I think the sum of the parts is much greater than the individual pieces.
Arvind Sood
Thanks very much, Sean. I think that’s a great place to end this call and continue the discussion when we see everybody at the business review on February 7th. I want to thank all of you for your participation this afternoon. If you have any follow-on questions, of course, myself and the rest of the investor relations team will be around for several hours. Thanks again.
Operator
Ladies and gentlemen, thank you for joining us for today’s Amgen’s fourth quarter and full-year 2012 financial results and conference call. This concludes today’s conference call. You may now disconnect.