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Amgen Inc. (NASDAQ:AMGN)

Goldman Sachs 35th Annual Global Healthcare Conference

June 11, 2014, 04:20 PM ET

Executives

Anthony C. Hooper - EVP, Global Commercial Operations

Analysts

Terence Flynn - Goldman Sachs

Amanda Lynam - Goldman Sachs

Terence Flynn - Goldman Sachs

Great. Thanks for joining us everybody for the beginning of the afternoon session here. I am Terence Flynn one of the biotech analysts at Goldman Sachs and we’re very pleased to welcome Amgen today. Joining from the company is Tony Hooper, EVP of Global Commercial Operations. I am going to turn it over to Tony for a few opening remarks and then I’ll launch in to questions and hopefully we’ll have a little bit of time at the end for any questions from the audience. Tony?

Anthony C. Hooper

Terence, thank very much and good afternoon folks. I thought I would spend a couple of minutes just talking about the Amgen strategy as we see it at the moment and that’ll maybe help us to guide the discussion.

So when I think about Amgen at the moment we start with thinking about the investments we’ve made both internally and externally over the last decade or so, is really moving towards paying handsome benefits now as we move towards launching a number of rather exciting and innovative products in the next couple of years. As you know we have about 10 drugs in late Phase III that we should be launching anywhere between ’15 and ’17.

When you think about these drugs the first one of course is ivabradine, the drug for cardiac heart failure, we just licensed from Servier. It's a drug that’s on the market already in about a 100 countries around the world and a unique and interesting mode of action and a high unmet medical need such as cardiac heart failure. Most of the Accountable Care Organizations are looking at how do we actually stop re-admission of cardiac heart failure patients.

We are in the process of completing that registration package as we speak now and then depending on how long the FDA takes to prove it we hope to launch in 2015. The exciting part about ivabradine is not just the unmet medical need and the fact we can bring a huge advantage to patients in need, but also gives Amgen for the first time an opportunity to enter into the cardiovascular market. This will be the first time we are working closely with cardiologists getting into institutions, talking to P&T communities, forming communities and understanding what’s required for discharge protocols, which of course is a lead in for evolocumab, our PCSK9.

As you know we’ve already reported out all our Phase III trials for evolocumab and we are in the process of putting together a package and we’ll be finding that on a global basis before the end of the year. That continues to be one of the largest opportunities we have as an organization, but the cardiovascular team will flow quite naturally from cardiac heart failure into lipid-lowering.

The next drug is TVEC, which we have completed now the Phase III trial and we have committed to file that in the not too distant future. The exciting thing about TVEC was the Phase I data we show in combination with ipilimumab, presented in ASCO which shows a dramatic increase in the complete response rate when used with ipilimumab without any of the side effects you’re seeing either with EP or with PD-1.

We are also about to initiate some combination work with Merck’s PD-1 and we look forward to this drug becoming an interesting regimen in the treatment of these diseases. As the PD-1s unleash the immune system TVEC allows you to realign the T- Cells to attack the cancer tumor cell.

We’ve also reported out the Phase II data on Blinatumomab for ALL which came out of the Micromet acquisition and the BiTE platform itself, and we are hoping the FDA will agree that the Phase II data is sufficient in this high level of unmet medical need to allow us to register or submit filing the listed product.

Then we have 827 or Brodalumab with the IL-17 for psoriasis, where we’ve seen our first Phase III trial come up this year; some rather interesting data in the PASI-100, where for the first time you are seeing a drug showing dramatic reduction of a 100% of the plaque in patients as opposed to the normal measure of only 75%. And then of course you have 785, Romosozumab for postmenopausal osteoporosis which is in full flight with Phase III at the moment and we should be getting some of those results coming out in 2016.

Last but not least of course, Kyprolis which came to us through the acquisition of Onyx last year is up and running in third line multiple myeloma at the moment and we keenly await the outcome of the ASPIRE and the FOCUS trials which we should be seeing in either the second or the third quarter this year. ASPIRE of course would allow us to move into the second line indication, which when I look at the numbers is any between twice or three times the size of the third line where we presently have an opportunity.

Secondly after the innovative opportunities we have, we truly believe that as Amgen with the experience and history we have around the development, the discovery, the regulatory and the manufacturing skills of biologics that we are in a unique position to have a major opportunity in what is appearing to become a rather interesting biosimilar market.

We have six products or six biosimilars in development at the moment, three of them in pivotal trials. The first four are four oncology drugs in which we have a partnership with Actavis. And the last two are in formation remicade and Humira and we should be launching our first biosimilar in 2017 in the U.S.

The third product we see in terms of advancing Amgen on top of the innovative products, the biosimilar strategy is our geographic expansion. Amgen has moved from been a U.S. partial North European-based organization to being a global company in the last three years. We are now present in more than 75 countries around the world and a number of rather smart acquisition deal and some business development has allowed us to have a presence in the largest growing international markets and we have a pathway now to grow our business profitability overtime and to bring the innovative Amgen portfolio to these markets.

This was partially assisted by the recent reacquisition of our Filgrastim rights from Roche and the reacquisition of our Prolia rights from GSK in Europe. So net-net we really believe that this strategy, together with this operating structure is what we at Amgen can do to deliver the maximum value of innovative medicines to patients in need and at the same time increase shareholder value.

The portfolio is changing, our geographic footprint is changing and what you will see from Amgen is a consistent level of fiscal discipline as we reallocate resources inside the P&L to get ready for the new launches. Earlier this year we’ve right sized both our nephrology organization and consolidated the information and the bone health organization which resulted in about 320 so people being eliminated.

These heads will be used to be re-purposed into cardiovascular sales people to get ready for the cardiovascular launches of ivabradine and evolocumab hence leaving us neutral on the P&L. So an exciting time for Amgen with these innovative products, people obviously worry about the months it's how we launch 10 innovative products in the next three years as an organization and the organization is clearly becoming focused around the critical path to maximum opportunities for launches. So let me stop there for a moment okay.

Question-and-Answer Session

Terence Flynn - Goldman Sachs

Well thanks. I think that’s frames a lot of the rest of the questions I had pretty well. But maybe just to start off, I mean you guys obviously have a lot going on the innovative product side. But just how does the company’s approach against the drug development and commercialization evolved under ACA, have there been any changes and as you look forward in terms of how this plays out over the next several years and what do you think are going to be the keys to successful development here of these products you are going to be launching?

Anthony C. Hooper

So as a biologic company the concept of access, reimbursement is really important and about three years ago we put together a dedicated separate Value and Access organization, staffed with some real professionals, who are intimately involved during the early development process, Phase II, Phase III to ensure that how we design protocols and what we put into protocols is essentially from a pharmacoeconomic perspective, so a highly sophisticated process to make sure when we go to market we can actually present the value proposition, not just from a clinical perspective but from a value and pharmacoeconomic aspect as well.

In the U.S. we haven’t seen much of a dramatic change in the way we see to our business because of ACO, and we don’t expect to see a dramatic change in the way we either develop drugs or bring drugs to market. But the ACOs are requesting what we have to already supply in Europe and a few other socially healthcare countries.

Terence Flynn - Goldman Sachs

Okay, great. And maybe in terms of one other thing we noticed is Express removed about 48 drugs I think from their preferred formulary earlier this year. ENBREL and Humira retained exclusive status, but what was it that you guys were able to do to drive that successful outcome there and how do you see that as an advantage, maybe versus some of your competitors as you look forward?

Anthony C. Hooper

So a combination of two things, obviously. I mean it starts with the clinical value your drugs are bringing and in the 15 year history that ENBREL has in the marketplace of delivering both efficacy and acceptable safety profile and so, but thirdly the whole concept of rebates exists and we have been in the market for a while. So the rebate discussions are with the large payers at the moment and that tends to lock them in for a while as well.

Terence Flynn - Goldman Sachs

Okay, and then one other more strategic question before we move on to the base business, obviously a large portion of your cash is ex-U.S. right now and just wondering as you look forward for use of that cash do you think M&A is the most likely use there or do you think there is going to be any progress in the tax reform front and how’s the company thinking about that, as that’s clearly an evolving situation?

Anthony C. Hooper

So as a company Amgen strongly supports U.S. tax reform. I think the ability to one day repatriate these funds at a different level and put us on a level playing field with non-U.S. companies is really going to be important. We need to ensure we can maintain both the innovation and employment in the U.S. by getting this tax right. Secondly we are always looking at acquisition opportunities and where our cash is has never played into a decision around the value of an acquisition or the importance of an acquisition and the ways and means to get it off and done.

Terence Flynn - Goldman Sachs

Okay, great. Maybe just as we move on to the base business, so ENBREL was just wondering if you can walk us through the current dynamics here, on both demand and pricing side and there are two separate markets are in psoriasis. Seems like in psoriasis there has been an increased amount of competition from Stelara, Celgene is going to be launching an oral product later this year, what’s kind of your latest thoughts on the ENBREL franchise?

Anthony C. Hooper

So as you know with ENBREL, we have prolonged exclusivity until about 2028, ’29. So we continue to look at ways and means of driving this franchise during that exclusivity period. The market itself in the U.S. both rheumatology and dermatology grew in the teens during the first quarter. In rheumatology we continue to be the first product of choice in terms of naïve patients coming on to a TNF, markets there appear to be fairly stable. There was a bit of a blip in the dermatology business, where it looked like some of the new data that Stelara had, had resulted in a bit of a bump in their market share. That seems to have stabilized again. So we are watching that carefully. We are moving back into some of the DTC work at the moment, and some of the patient support.

When you think about that market it’s all acquiring patients, so therefore initiating patients early on, keeping patients on the drug. If you lose patients in the first six months it’s unlikely you’ll get them back again. If you keep them on post the six months you see that they will have pretty long treatment period so it’s making clear on how do we find new patients and help physicians make decisions on those. And then once you’ve got them how you keep them with nursing programs to help patients in need.

Terence Flynn - Goldman Sachs

So what kind of impact would you expect an oral drug to have in that setting?

Anthony C. Hooper

So we have one oral drug in rheumatology as you know. Celgene has been out there for quite a while now. We take all competition seriously and we watch this one. I think Celgene has about a 3.5% market share at the moment. So we’ve seen minimal impact from Celgene in terms of what they have taken from us. Apremilast is an interesting product, but I think it’s going to be more positioned for mild to moderate psoriasis and I don’t see it really competing in severe psoriasis with the TNFs.

Terence Flynn - Goldman Sachs

Okay, maybe just one more on the psoriasis front, you mentioned this in your opening remarks that you reported the first Phase III data for A-27. Looks like a pretty exciting class, obviously highly active. But just give us your perspective on how this drug would be positioned in that treatment paradigm? Would it be [inaudible] relative to ENBREL, relative to the competition and how do you really differentiate it?

Anthony C. Hooper

So treating psoriasis is a -- it is a range of options based on the severity of disease and the patient profile itself. And in spite of ENBREL’s efficacy and very good safety profile in this disease a number of other products are used as well and physicians are consistently looking for ways and means of finding new treatment for patients. So I see no real issue in our ability to co-position both drugs as options to dermatologists once we come to market.

What is exciting is the Phase III data we have seen now, the first Phase III data just looked at the PASI-100 to PASI-90 and for the first time to see a drug get a PASI-100 of 46% is really special. Historically because of a lack of efficacy of these drugs a PASI-75 was the measure, which is an assumption that if you clear 75% of the plaque of patients, they can live happily with just 25%, which to me is unacceptable. Psoriasis has an unusually high level of suicide with [inaudible] effect, because it is a difficult disease to live with and for us to really move forward and get society to accept that a 100% eradication is the new hurdle is where we want to be.

So the next two trials that are coming include a head-to-head versus Stelara. So that’s going to be important to really establish ourselves from an efficacy perspective before we can plan.

Terence Flynn - Goldman Sachs

And I guess how important is that data to driving the ultimate pricing position or do you think that’s pretty well established just given where TNFs are?

Anthony C. Hooper

I think the pricing is pretty well established at the moment. I think choices would not be around price going forward but choice will be around efficacy and tolerability over a longer period of time.

Terence Flynn - Goldman Sachs

Maybe before we move on to the Dmab franchise, so XGEVA you guys have cited potential disruption from the generic Zometa in the past, maybe what have you -- have you seen currently and what’s the strategy really here going forward?

Anthony C. Hooper

So XGEVA in the U.S. in spite of being in the presence of six or seven generic Zometas grew “unit market share” and dollar share is now in excess of 70% of the market. So we continue to believe that there is an opportunity for this product to continue to grow in the U.S. The ASP lag will start disappearing in the third quarter this year. So there is no financial incentive whatsoever for physicians to be thinking about Zometa going forward and the team is now reworking the whole campaign around efficacy and the reason to believe.

In Europe we are now in all major markets with XGEVA, uptake has been exceptionally good, and we continue to expand market placement.

Terence Flynn - Goldman Sachs

Okay, and then on the Prolia side, what’s really the growth opportunity here I guess, both U.S. and ex-U.S. as you look forward?

Anthony C. Hooper

When I look at both Europe and the U.S. in terms of eligible PMO patients, the market share is still in very low teen numbers. So when you think about opportunity for growth we are only just touching a very small number of patients, I mean we’ve grown in the U.S. from about 8% to 12% market share, but there continues to be an opportunity to grow beyond 12% without doubt. And we’ve now just recently launched in France, relative first time when we launched but all major markets are now covered.

Plus as you know we’ve recently reacquired our rights from GSK back. When we did the deal we assumed a different label and assumed a higher level of primary care physicians prescribing. The label we received was much more narrow and much more high risk patient and it’s become clear that most of the prescriptions are coming from specialists which we feel we have an ability to manage ourselves exceptionally well and actually don’t need any assistance. So taking back we see we can actually drive sales better at lower cost.

Terence Flynn - Goldman Sachs

And what would you put out there as kind of a target for market share that you think is realistically achievable if you look forward over I guess the next three to five year period.

Anthony C. Hooper

I don’t think I’d be prepared to commit that number because my boss will get upset with me, hopefully we will do it. But I do think when you think about postmenopausal osteoporosis and the danger that women live in, in terms of bone fractures that we don’t treat enough patients. The market itself has contracted a bit in terms of the number of patients who are kept on [Romosozumab]. So the unmet need hasn’t gone away, the number of patients treated has just reduced.

I think as physicians continue to see the level of safety of this product and the ease of using Prolia with one sub Q injection every six months or so, so the market continues to expand.

And this is not an oncology drug when you reach your peak sales in three four years, this is a chronic care product that’s going to keep growing for a number of years to come as more and more physicians get comfortable. It's a combination of existing high prescribers who prescribe at a deeper level and non-prescriber who eventually moves to become prescribers.

Terence Flynn - Goldman Sachs

What about Kyprolis? I mean I was surprised I guess the last couple of quarters, it seems like the drug’s plateaued somewhat here in the U.S. and one of the things that we focus on just treatment duration and I think we expect that to may be continue to increase here as the product rolls out in the latter stage setting. But may be walk us through your thoughts on what’s driving that franchise in later line setting right now.

Anthony C. Hooper

So Kyprolis you know we have at the moment a third line plus indication and we presently hold the lion’s share of the market in third line. In fact our market share based on the data we’ve run is more than double our next competitors in the third line. So from a patient capture perspective there is a finite level of growth you can get in the third line. Time on treatment is exactly where we are spending quite a bit of time. To make sure first of all the patients are getting the right dose and number two they are staying on the drug as long as the drug is giving them benefit and value.

But I think we are just about seeing a peak in the third line area for Kyprolis at the moment. The next time we’ll see a major inflection curve in the Kyprolis revenue line will be when the ASPIRE data gets into our label and ASPIRE as you know is events up in trial. We are just waiting for those events to happen, events of death. And we expect that anytime in the second or the third quarter this year. That would give us an opportunity to move into the second line for the first time.

And when I look at the numbers the second line indication for multiple myeloma is between two and three times the size of the third line market. So a pretty large increase opportunity for Kyprolis. In addition to that then we have ENDEAVOR and CLARION trials running. ENDEAVOR is a trial head-to-head versus Velcade which will establish our efficacy against Velcade and give us a better opportunity for growth in both second and third line and then ENDEAVOR of course is in the first line indication and first line multiple myeloma again is at least as big as second and third combined. So kind of two levels of opportunities as we go forward into second line and then to first line.

Anthony C. Hooper

And how important from a competitive standpoint I guess you think the once weekly dosing schedule is for Kyprolis? I know you guys reported some interesting data at ASCO a couple of weeks ago. But how important as you see kind of this drug move upstream do you think that is to the value equation?

Anthony C. Hooper

So I think you got to start with multiple myeloma is a deadly disease that results in people having an untimely early death. So I think anyone you talk to that’s treating multiple myeloma talks about efficacy, efficacy, efficacy and then that’s where Kyprolis focuses on clearly. The reason we became excited about the drug was the data showed us from an efficacy perspective this one could be without doubt best in class.

As you move up into the first line and patients are on therapy for longer, so the convenience factor starts to become important and to be able to move from twice weekly to once a week would really be beneficial in the longer term as you move into the first line. As you say that champion there looked pretty good, 70 milligrams a week and we will continue to proceed there as far as we can.

Terence Flynn - Goldman Sachs

Okay. And so it sounds like data from Focus and ASPIRE still 2Q, 3Q, any projection about which of the two trials is going to come first or second?

Anthony C. Hooper

They are both event driven, and events happen, managed by someone else, where the greatest or even line opportunity there, it’s frustrating to wait but obviously the longer we wait, the longer patients are living and that’s a good thing.

Terence Flynn - Goldman Sachs

Okay. Maybe just moving on to the G-CSF franchise so obviously Teva introduce then for the first time some competition here in the U.S. the short acting version and a long acting version in Europe. But may be just give us your thoughts on that impact of that from a competitive standpoint and I think you mentioned on your earnings call that you are responding accordingly to maintain your leadership position, so just wondered if you can provide a little more insight on in terms of what those actions have been?

Anthony C. Hooper

So net-net from a global perspective the impact of the long acting competition and the short acting competition in Europe and in U.S. has been marginal. Both products that have been launched are not biosimilars they are different products with different labels. The long acting, Filgrastim which is the pegylated version that was launch in about August last year is now in eight to 11 countries in Europe, market share is around about 3% on an average across the board. In the U.S. that launched in November of 2013. They have about 20 plus accounts and haven’t quite achieved 1% market share yet.

Terence Flynn - Goldman Sachs

Okay, so pretty minimal. And would there -- is there anything that any of your accounts are looking for in terms of maybe future data out of Teva or more experience before they change their current habits, could that be a risk?

Anthony C. Hooper

As I said I mean the trials they did were slightly different. And therefore and look the label they have for GRANIX is different than we have for NEUPOGEN. So it's not like you are comparing two identical drugs. It's clear that they are having to spend time with physicians to make sure they understand the clinical data and become comfortable. There are some small institutions that have been prepared to switch, they have price discounts of anywhere between 18% and 22% and some small accounts switched in.

Terence Flynn - Goldman Sachs

Okay. And may be moving on to their cardio franchise so ivabradine that [defined] for FDA approval in the near future. And maybe just walk us through the timing of your commercial build, you talked about redeploying some of those assets and as you restructured your sales force, what’s the timing there? And then anything in terms of sizing the footprints of I think you mentioned about 300 in terms of headcount, is that -- is all of that going to be in the cardio franchise? Or is there anything beyond that?

Anthony C. Hooper

So for the ivabradine launch it’s clearly a focused launch around cardiologist and a number of identified institutions. Most of the heart failure patients are admitted, kept and then discharged and the question is, can you actually get people to understand the value of this drug to ensure the P&Ts and the formulary committees includes this now in a discharged protocol. So we haven’t landed exactly on the numbers yet and but it will be a specialty focused launch clearly directed at getting discharge protocol aligned with the value of ivabradine.

As we then move towards evolocumab we will start understand the market bit better and understanding whether we need to expand slightly more as we go forward. But at this stage we are not quite lined up.

Terence Flynn - Goldman Sachs

Okay, and in terms of the market opportunity there may be just give us an update in terms of what the market is in Europe and the may be compare that to the U.S. opportunity for instance.

Anthony C. Hooper

So when we look at U.S. the big five in Europe and Japan as the Western world opportunity, we find about 17 million patients who are high risk cardiovascular patients with or without co-morbidity who are 30% higher than the LDL goal should be and that’s 100 in Europe and Japan 70 in the U.S..

So we truly believe that the size of the market continues to be there. I think if you look at everything trial that being published since 1992 it shows the [linearness] of the flow of as you reduced LDL so you reduce mortality and mobility from cardiovascular event itself. And if you are a high risk patients who have an event and for some reason your LDL is not being driven down because it's not working where you are in tolerance for your FH patient you are looking desperately for something else to flow. So in the beginning we will launch with this surrogate end point of LDL flow in and so we are assuming a more limited population that will become available to us all that 17 million either by physician choice, patient choice or payer controls and extend.

Once the outcome is there and if the outcome shows that in fact as you drive LDL down so you continue to drive a reduction in mortality and morbidity it's going to be very difficult for anyone to try and to stop physicians and patients who want to get…

Terence Flynn - Goldman Sachs

And can you refine that a little more for us in terms of the opportunities seen near term I guess for PCSK9? So you mentioned 17 million patients but as you think about kind of a near term pre-outcome population versus post-outcome, I mean this 1 million, 5 million.

Anthony C. Hooper

So that’s the work we try and do at the moment and it's difficult to tease out within that 17 million the definition of high risk and the willingness to take action. But we continue to believe that it's a fairly large group of patients. I think the science is so strong that even when you launch without outcome data people will be thinking about the science around this product that potentially has the opportunity to reduce side effects. Patients who had a disease had a heart attack are on our staffing, know they are on for a reason and when you see you numbers and you are not sort of taking your numbers down then that’s a concern.

Terence Flynn - Goldman Sachs

And what I mean -- some of the push back we did just on the obviously then the need for an injection here in this market and some of the things, I guess the investors point of view just you’ve got Byetta, you’ve got Prolia and kind of the launch out of the gates of those drugs. I mean how do you think this is a PCSK9 class might be different or similar to those two potential proxy’s that people have looked at?

Anthony C. Hooper

So we have this scar in our back from having been one of the first companies to launch an injectable into the primary care market. So we have learnt a lot in terms of what works, what doesn’t work and we will use all those skills, all that knowledge going in, a cardiovascular patient is normally very, very aware of the message they’ve been sent in terms of a near death experience which is different to a build of a chronic disease over time where you consistently try and pretend you are infallible and you don’t need any treatment.

Cardiovascular patients are either carrying a scar down their chest due to a bypass or they are carrying a stent inside their body or they have some type of disability due to a stroke and it reminds you every day. And if that’s your patient population I think you are going to be much more willing to some give yourself a little injection once a month or once a week, two weeks then a few other areas.

Terence Flynn - Goldman Sachs

Okay, great. Do you have any questions in the audience? Yeah.

Amanda Lynam - Goldman Sachs

Thank you. Amanda Lynam, Goldman Sachs. Tony this may be a little bit out of your everyday focus. But can you talk a little bit about the capital management strategy of the company? And right now do you see a need to reduce leverage on the balance sheet and to free up financial flexibility to the extent that you do see more attractive acquisition or business development opportunity? Thank you.

Anthony C. Hooper

Right. So I am reminded every day that I am part of the capital management strategy and that is that what I spend needs to have a very clear ROI and that’s why when we talk about capital management our strategy hasn’t changed. I mean clearly aligned to delivering value back to shareholders we have the dividend ourselves, committed to increase that dividend. As you know we’ve increased it about 30% per year since we started.

The focus is around fiscal discipline, the management of resources, the reallocation of resources, importance of understanding what’s required to launch, and that you don’t overspend, but that you don’t underspend either. So we want to source properly and make sure we have sufficient funds. We don’t have any plans in the ’14, ’15 period for any large share repurchases, but the commitment to pay the dividend is still there. And I am responsible for creating most of the cash.

Terence Flynn - Goldman Sachs

Great, that helps. I think we are out of time, so thank you very much Tony.

Anthony C. Hooper

Thank you, appreciate it.

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