Earnings Labs

Amgen Inc. (AMGN)

Q1 2018 Earnings Call· Wed, Apr 25, 2018

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Transcript

Operator

Operator

My name is Inn, and I will be your conference facilitator today for Amgen’s First Quarter 2018 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Arvind Sood

Analyst

Okay. Thank you, Inn. Good afternoon everybody. I would like to welcome you to our conference call for the first quarter of 2018. I think we are off to a solid start with new and recently launched products continuing to deliver volume driven growth including our most recent launch of Parsabiv. We also have notable catalysts to look forward to, like our upcoming FDA action date for Aimovig for migraine prevention. Our Chairman and CEO, Bob Bradway will lead the discussion today with a strategic overview followed by our CFO, David Meline who will review our results for first quarter and provide updated guidance for 2018. Tony Hooper our Head of Global Commercial Operations, will dig into out product performance during the quarter, followed by our Head of R&D, Sean Harper, who will provide a pipeline update. We will use slides corresponding to our prepared comments today and a link to these slides was sent earlier. We plan on using non-GAAP financial measures in today’s presentation to provide information, which maybe useful in understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results and reconciliations of these measures are available in the schedules accompanying today’s press release, our Form 8-K and also on the Investor Relations section of our website. So, just a reminder that some of the statements made during the course of our presentation today are forward-looking statements and our 2018, 10-K and subsequent filings identify factors that could cause our actual results to differ materially. So with that, I would like to turn the call over to Bob. Mr. Bradway?

Bob Bradway

Analyst · Andrew Peters from Deutsche Bank

Okay. Thank you, Arvind. Thank you all for joining us. As you can see, we're off to a solid start in 2018 with 3% growth in product sales leading us to 10% growth in non-GAAP earnings per share. We had double-digit unit growth in all of our new and recently launched products including Repatha, KYPROLIS, Prolia and XGEVA. We also generated strong volume growth outside of the U.S. where our legacy brands have faced competition for some time. Repatha, KYPROLIS, Prolia, XGEVA and soon Aimovig are clear examples of innovative medicines that address real unmet needs. These will be important drivers of our long-term growth. In addition, we continue to invest in R&D to develop new game changing medicines like omecamtiv, tezepelumab and in the earlier stage molecules like our IL-2 mutein all of which have clear potential value propositions for patients and society. In addition the broad promise of our BiTE platform is coming into focus across a number of molecules in our cancer pipeline. The recent approval for BLINCYTO in ALL patients with minimal residual disease gives us confidence in this approach to immuno-oncology for both liquid and solid tumors. We're looking forward to launching Aimovig, our first neuroscience therapeutic, which is in turn a first-in-class CGRP antibody for migraine prevention. Together, with Novartis we're ready to launch Aimovig this quarter in the U.S. We hope to redefine migraine prevention for relevant patients, physicians and payers given the urgent unmet need and the pent up demand for a better therapy in this disease. Current therapies do not adequately address this debilitating disease and migraine is gone under appreciated and under treated for too long. Later this year we will see our biosimilar effort begin to come to fruition as we launch AMGEVITA our biosimilar of Humira internationally. We…

David Meline

Analyst

Okay, thanks Bob. We're pleased with our solid revenue and earnings growth in the first quarter. As our transformation, efforts continue to enable investments in support of volume driven growth during a time of portfolio transition. Turning to the financial results, on Page 6, of the slide deck worldwide revenues at $5.6 billion in the first quarter grew 2% year-over-year. Worldwide products sales at $5.3 billion in the first quarter grew 3% year-over-year as strong unit demand for our new products outweighed declines in our mature brands. We are particularly, encouraged by our 11% year-over-year volume growth in Europe, reflecting the value of our innovative products in a market where we have experienced bio similar competition and portfolio transition for a number of years. Other revenues at $211 million decreased $54 million year-over-year due to an unfavorable compare related to milestone payments received in Q1 of 2017 partially offset by higher royalty income in Q1 of this year. Non-GAAP operating income at $3 billion grew 1% from prior year. Non-GAAP operating margin was 56.9% for the first quarter. As in prior years, our operating margin is expected to be lower in the remaining quarters of the year driven by the timing of expenses. As mentioned last quarter, we continue to evaluate incremental investments in our products and pipeline as well as external opportunities to drive growth and maximize shareholder value. On an non-GAAP basis, cost of sales as a percent of products sales improved by 0.4 points to 12.7% driven by lower royalty expense partially offset by increasing manufacturing costs. Research and development expenses at $739 million, were relatively unchanged in the first quarter of 2018 versus last year. Research and development as a percent of products sales at 13.8% is lower in Q1 consistent with previous years. Going forward,…

Tony Hooper

Analyst · Geoffrey Meacham from Barclays

Thank you, David and good afternoon everyone. You’ll find our product sales starting on Slide number 10. Our business, continues to shift to more volume driven growth, as we continue to launch innovative products targeting large patient populations with unmet medical needs. We're off to a solid start to the year, with all of our newer products delivering double digit growth. The total portfolio grew at about 3% as the legacy brands, some of this volume growth. As has been trend for the last number of quarters our ex-U.S. business continues to grow more rapidly generating 7% growth excluding the impact of foreign exchange fueled by 9% volume growth. In many of our ex-U.S. markets we've already experienced a majority of the decline of a mature brands demonstrating the growth potential of our newer portfolio. These markets serve as a model, for the overall company's future growth profile. We’re also in deep preparation for the upcoming launches Aimovig for migraine sufferers and the first of our bio-similar portfolio. A majority of the sales teams are trained and in place and subsequent investment levels will continue ramping up throughout the year. Let me now turn to our brand performance. Prolia, leading brand osteoporosis therapy grew 16% year-over-year primarily from volume. We continue to drive growth of new patients, as well as improved repeat injection rates. This results in an increasing share of postmenopausal osteoporosis segment, as patients and physicians realize the benefits Prolia. As a reminder, given a six month dosing interval Prolia exhibits a seasonal sales pattern with quarter one and quarter three representing lower sales, than quarter two and four. Overall market penetration either is still low in the 20% indicating, significant potential for improved diagnosis and treatment. With this unique profile and through an increased investment we expect…

Sean Harper

Analyst · Alethia Young from Credit Suisse

Thanks Tony and good afternoon. I'll begin my comments today with a brief overview some key milestones from Q1 and then highlight a few early stage innovative programs we find particularly promising. We recently received several important regulatory decisions in Europe, including the approval of an expanded indication for XGEVA prevent skeletal related events in patients with multiple myeloma. We also received several positive opinions from the CHMP including recommendations for the addition of our cardiovascular outcomes data to the Repatha label. A Neulasta label variation to include the Onpro kit and a marketing authorization for KANJINTI, our biosimilar Herceptin, I would note that KANJINTI, has a PDUFA action date next month in the United States, also in the U.S. BLINCYTO received accelerated approval and orphan designation for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia with minimal residual disease or MRD. There are now technologies that allow for exquisite sensitivity in detecting at a molecular level whether residual disease are suppressant. MRD is the strongest prognostic factor for relapse in ALL patients and in our Phase 2 study of ALL patients in complete remission that were positive for MRD, 81% achieved MRD negativity after a single cycle of BLINCYTO. This was the first step for approval for the treatment of MRD by FDA and we're gratified that our first BiTE therapy is meaningfully advanced the oncology field. This approval presents a paradigm shift not only in the treatment of ALL but also potentially in other diseases were extremely potent therapies are being employed as such we're incorporating MRD into all of our clinical studies as appropriate. And we continue to develop therapies that drive deep and durable responses. For the first time, there is talk of actually achieving cures and what have been fatal diseases…

Bob Bradway

Analyst · Andrew Peters from Deutsche Bank

Okay. Thank you, Sean. Inn, we turn over to our question time now and perhaps you could remind our callers of the procedure for asking question.

Operator

Operator

Certainly. [Operator Instructions] Our first question is from line of Geoffrey Meacham from Barclays.

Geoffrey Meacham

Analyst · Geoffrey Meacham from Barclays

Afternoon, guys. Thanks a lot for the question. Tony for Aimovig, I know we’re close to the launch and I realize it’s competitive. But maybe if you could help us with kind of how you see the size and scale of the commercial organization. And from a reimbursement perspective, maybe what are the lessons to be learned from the PCSK9 experience when you look to the migraine launch. Thank you.

Tony Hooper

Analyst · Geoffrey Meacham from Barclays

Geoff, let me try and answer it in two ways that we are going to market together with Novartis. Novartis have a rich history of presence in the neuroscience market, both in terms of the salesforce and an outstanding medical organization. We have complementing it with both teams calling on specialists as well as some of the primary care physicians who have a propensity to look after patients with severe headaches or migraines. From a timing perspective, we clearly are in the lead. We look forward to launching first unlike the PCSK9 situation. We had to follow. We will actually sit in the price of cells. And this is clearly a market where patients have huge symptoms and actually know when they’re not being properly treated. So we look forward to a large dose of patients who want to come of this drug as quickly as possible.

Operator

Operator

And our next question is from the line of Andrew Peters from Deutsche Bank.

Maryana Breitman

Analyst · Andrew Peters from Deutsche Bank

Yes. Hi guys, thank you for taking the questions. Maryana Breitman for Andrew Peters. I wanted to ask about a possible strategic moves, do you see [indiscernible] like new platform or technical capability or an individual products and what stage products would those be?

Bob Bradway

Analyst · Andrew Peters from Deutsche Bank

Well. I’m afraid your phone line was breaking up. So we couldn’t hear the question. Do you want to try to repeat that and then Inn, if we can’t hear at this time maybe you can recycle her towards the bottom end of the call. Sorry, won’t you try again, let see we can hear you.

Maryana Breitman

Analyst · Andrew Peters from Deutsche Bank

Can you hear me now?

Bob Bradway

Analyst · Andrew Peters from Deutsche Bank

Not great. Why don’t we get you on a different line and ask our operator Inn to help you get back in the queue.

Maryana Breitman

Analyst · Andrew Peters from Deutsche Bank

Okay, Thank you.

Operator

Operator

All right. While recycle our back through, our next question is from the line of Terence Flynn from Goldman Sachs.

Terence Flynn

Analyst · Terence Flynn from Goldman Sachs

Hi, thanks for taking the question. Bob I think previously on some of the prior calls, you referred to access capacity in the system. I was just wondering if you can update us on your latest thoughts there particularly in light of some of the consolidation we’re seeing on the services side of the industry. Thanks a lot.

Bob Bradway

Analyst · Terence Flynn from Goldman Sachs

Nothing new Terence. As I said in my remarks, we’re continuing to look at ways to use our balance sheet to strengthen the business, continuing to look at ways to invest in innovation. So we’ve made our – I think our points on that topic well known and I wouldn’t say, there’s been change over the course of last quarter.

Operator

Operator

And our next question is from the line of Christopher Raymond from Piper Jaffray.

Christopher Raymond

Analyst · Christopher Raymond from Piper Jaffray

Hi, thanks guys. Just one question on Enbrel. We kind of struck Tony by your prepared comments. I know you talked about this last quarter that Q1 would represent, I think you said 20% of the annual number for full year 2018. Just doing the math I think that would infer Enbrel revenue of about $5.5 billion for the full year. And I know you guys don’t want to give guidance at any more granular than you’ve already given. But that numbers a lot bigger than consensus and what actually imply on up year-on-year number which would seem to be a reversal from what we saw 2016 to 2017. So I just want to if you could verify that, first of all, is that math is right. Maybe sort of talk about the driver there in terms of that trend reversal. Thanks.

Tony Hooper

Analyst · Christopher Raymond from Piper Jaffray

Yes. So let me confirm again that quarter one is normally a 30 low quarter, because of the need for re-verification, the need for the reset of deductibles. So patients pick up in the second quarter. We said last quarter that we expected this quarter to be about 20% of the total annual revenue and then probably landed up at – being at about 21%, almost 22% of what I expect the full year to be. So my number don’t get as high as yours.

Christopher Raymond

Analyst · Christopher Raymond from Piper Jaffray

Got it, thank you.

Operator

Operator

And our next question is from the line of Ying Huang from Bank of America Merrill Lynch.

Ying Huang

Analyst · Ying Huang from Bank of America Merrill Lynch

Hi, Thanks for taking my question. I was wondering maybe Tony, can you comment on the recent ICER draft analysis on a cost benefit on Aimovig, and actually propose that wrench of the pricing. Would you actually take that into your consideration when you price Aimovig? Thanks.

Tony Hooper

Analyst · Ying Huang from Bank of America Merrill Lynch

Ying, so a couple of things. One, it is a is a draft publication by ICER. They are requesting public comments up to an including, I think the 8 of May. So a number of organizations are busy commenting on that. It is the second publication, obviously, if you remember that that they has already been one publication, which took place on the 23 of March in the Journal of Medical Economics, authored by a number of headache specialists and economists, which laid out in very clear value range for this particular category. The ICER report doesn’t seem to take into account things such as absenteeism and presenteeism, which we would argue is really an important thing to look at from both an employee perspective and an employer perspective. But all of these ranges for within a reasonable level that will be discussing with the payers.

Operator

Operator

And our next question is from line of Alethia Young from Credit Suisse.

Alethia Young

Analyst · Alethia Young from Credit Suisse

Hey, guys. Thanks for taking my question. Just a question on AMG 592, just curious if there’s any kind of particular preclinical work that suggests an opportunity favors maybe lupus, RA or GvHD? Or is it kind of still an open question. Is there also the possibility for less frequent dosing there?

Sean Harper

Analyst · Alethia Young from Credit Suisse

So we – this is a half-life extended kind of a construct that we’ve designed. And I think that we have some, of course we have preclinical models of these diseases. But I would say that when you’re working with such a different mechanism than has ever been applied to autoimmune disease before. Our faith in the predictive nature of these animal models of diseases like lupus and RA and so on is modest. So we use all kinds of scientific reasoning and the animal models to guide us into kind of the initial set of experiments that we chose. But it’s fair to say that like was the case when for example TNF inhibitors came available or IL-17 and so on. It’s ultimately important screened through humans with these diseases to determine, whether the mechanism can be fruitful.

Operator

Operator

And our next question is from the line of Robyn Karnauskas from Citi.

Unidentified Analyst

Analyst · Robyn Karnauskas from Citi

Hi, this is Kripa on for Robyn. Like you mentioned earlier, you’re developing therapies in multiple modes such as BiTEs and CAR-Ts to target the same indications and you have a lot in the pipeline. I was just wondering if you can take us to your thought process on how you decide to target the same indication with two different modalities or how you decide to go in one direction versus the other.

Sean Harper

Analyst · Robyn Karnauskas from Citi

Right. So it’s a good question, I mean the first thing I would point out is that, at the moment moving into the clinic. We really just have a few CAR-Ts and we deliberately matched a couple of them with BiTEs so that we could actually, scientifically determine the pros and cons of these technologies. Because the data that exists today are very much apples and oranges in terms of the patient populations and the way that they’ve been pre-conditioned for example before being treated with, let’s say, CAR-T cell versus BLINCYTO, even when you get into diseases that are on the surface the same ALL for example or the various forms of CD19 positive lymphoma. So I don’t want to give you the – you to get the impression that for lots and lots of our targets we have double programs. We have helpful that are designed specifically to, hopefully in humans give us some understanding of whether the benefit risk looks better for one these hyper technologies versus another. And so that’s kind of an approach and we like to understand that in both hematologic and in solid tumor settings. Ultimately what will determine what we move forward with is, primarily in oncology is going to be efficacy, right with an acceptable amount of safety. And what we really don’t know yet is whether you can get some generally similar kind of a clinical benefit from – for example, a bite intervention versus a CAR T, it would be hard to imagine that you would select the CAR T under those circumstances given a lots of consider practical, considerations cost to goods and thing in that sort. It’s early days, I don’t think anyone has ever really made these comparisons, there is a lot of speculation. And we’re hoping to shed some actual light on these clinical questions.

Operator

Operator

And our next question is from the line of Geoffrey Porges from Leerink Partners.

Geoffrey Porges

Analyst · Geoffrey Porges from Leerink Partners

Thanks very much for taking the questions. Sean, list on your milestone still romosozumab in both U.S. regulatory submission and European review. Could you give us some update on your expectations for the labeled indication and the sort of size of the addressable patient population for romosozumab now?

Sean Harper

Analyst · Geoffrey Porges from Leerink Partners

Sure. Yes, I think that with romo, we’re at this point where we’re well into a process of discovering the entire clinical data base experience with the molecule to make sure that we have every cardiovascular event that may have occurred in any of the trials and then run them through a new blinded adjudication process. Well that make sound easy, it’s actually quite time consuming and requires coordination between us and another clinical center in this case Timmy. So that’s underway and I think the results of that are going to be very important in determining where we end up with the product. Obviously the unmet need for this kind of anabolic product it’s very strong. The compelling need for it, the efficacy was very favorable. And it’s a short period of treatment one year, so I think that what we really need to understand is do we believe that there is actually a cardiovascular risk because as you know, Geoff, we have two studies they can’t both be true, one of them says there’s a risk the other one says no. So if we get some additional information from this reanalysis it could tip the scales in one direction or the other, we’re just seeking the truth. And then whatever the truth is it will make its way into the label. So it’s a little bit hard to know where that benefit risk will land and whether we’ll be talking about a patient population that has a particularly significant level of unmet need and therefore it makes sense to use it in a context in which we actually believe there’s a cardiovascular risk versus that the cardiovascular risk seems to be much less of a true phenomenon. And so that’s the best I can do to characterize that at this moment.

Operator

Operator

And our next question is from the line of Michael Yee from Jefferies.

Michael Yee

Analyst · Michael Yee from Jefferies

Hi. Thanks for the question. I have a question for Bob. I mean, I guess there was a large M&A deal in the space last week. But I guess more important big picture your view of the environment given that there has not been that many deals. Do you feel for Amgen it is more of a case of not finding things that are good fits or it’s a price issue? I guess maybe you could talk about the overall dynamic when you are looking at all of these different biotech companies. Thanks so much.

Bob Bradway

Analyst · Michael Yee from Jefferies

Again I think, we have a track record of being pretty disciplined. The way we evaluate targets, our focuses on being confident that we have a pathway for our shareholders to earn a return. But we’re looking for ways to invest in our industry, we’re interested in innovation that aligns well with our six therapeutic areas that we focus in. And opportunities that are consistent with our desired advance innovation globally. But I think Mike, historically the evolutions have been challenged in this sector. We see a little bit of adjustment taking place now. And we’ll continue to be thoughtful in reviewing all the different opportunities. So we think can help us earn a return for our shareholders and help make a difference for patients.

Operator

Operator

And our next question is from line of Eric Schmidt from Cowen and Company.

Eric Schmidt

Analyst · Eric Schmidt from Cowen and Company

Hey, congrats on a great start to 2018. Maybe a question for Tony on Repatha. Since the presentation of the ODYSSEY data have you seen any changes in market share or any change in your pricing discussions with payers? Thank you.

Tony Hooper

Analyst · Eric Schmidt from Cowen and Company

Eric, we saw an increase in the NBRxs after the outcomes data came into Repatha’s label. Since the ACC, we’ve seen relatively little change in the marketplace to date.

Operator

Operator

And our next question is from the line of Umer Raffat from Evercore ISI.

Umer Raffat

Analyst · Umer Raffat from Evercore ISI

Hi. Thanks so much for taking my question. Bob, my question is there’s been a lot investor feedback on a possible merger of equals like a transformative deal between Amgen and a big pharma name – a European pharma name in particular. How do you feel about a transformative M&A situation? Is that something you’re open to philosophically or is the focus really more on Smith Biotech.

Bob Bradway

Analyst · Umer Raffat from Evercore ISI

Our focus somewhere is on finding opportunities to invest in innovation, again, we think we can make a difference innovation is focused in the areas that are important to us and opportunities that enable us to continue to expand our global footprint. So, I think speculation rises and falls through time at our industry. But our focus on those things has been consistent as has our determination to have a pathway to earn a return for our shareholders through our business development activities.

Operator

Operator

And our next question is from the line of Cory Kasimov from JPMorgan.

Cory Kasimov

Analyst · Cory Kasimov from JPMorgan

Hey, good afternoon. Thanks for taking the question. I wanted to ask about CGRP and recognizing the competitive nature of this class. But with the article out this morning commenting on Express Scripts intention to push for lower list prices on the CGRP class to limit out of pocket cost borne by patients and implement a pay for performance type of model. Would you say this is consistent with the interactions you’ve had with payers and maybe how you’re thinking about different pricing models for this class following on the heels of some of the more unconventional pricing scheme as you’ve implemented for PCSK9s. Thanks.

Tony Hooper

Analyst · Cory Kasimov from JPMorgan

So Cory let me start that one and I’ll let Sean to talk about some of the differentiation between our product and the others that are trying to come to market. Clearly, we are in the lead as they said and coming to market first is important it allows us to set the baseline price. We look very carefully at the value based pricing has come forward. We’ve listened to the affordability question in the marketplace with the ESI or looking at value based prices and look forward to them opening up access in those situations to allow – access to appropriate patients. And we will continue to come forward with prices that are responsible that take into account the co-pay requirements as best we can. We have a number of risk based contracts on the table with Repatha and we’ve acquired to pay that talk to players about risk based complex with Aimovig. So let me ask Sean to talk a little about why we think this drug is actually very different to the others coming to markets.

Sean Harper

Analyst · Cory Kasimov from JPMorgan

Well, Tony I think that there’s a number of things to just point to in terms of the advantage besides being first to market. I first of all, we are a receptor antagonist and that is still the case, we’re the only receptor antagonist in the clinic and we chose that path for a number of reasons. But one of them was potency and so we seem to be the only product that doesn’t require loading doses or intravenous administration, which can be quite an awkward thing for patients and providers in general. We recently developed the data and this is being presented today in this population and highly refractory patients who failed as many as four prior prophylactic therapies and the data looked really strong in that group. So that’s a differentiated data set. And I think also remember that when physicians are dealing with patients and it is encratic either adverse reactions or lack of – or presence of efficacy they have to choose between different agents within a class. Generally speaking, a physician is if they started with for example one of the ligand sequestering antibodies going to another ligand sequestering antibody doesn’t make a whole lot of sense compared to trying a receptor antagonist. So we hope that the receptor – us being the only receptor antagonists would result in more therapeutic sort of options for physicians who are trying to manage this very challenging condition.

Operator

Operator

And our next question is from the line of Carter Gould from UBS Equities.

Carter Gould

Analyst · Carter Gould from UBS Equities

Afternoon guys. Thanks for taking the question. I guess commercial question for Tony on XGEVA. Hoping to get a little bit more detail on the uptick in the quarter, if you could maybe provide some rough detail on the size of the buy end versus how much was driven by myeloma. And you provided some anecdotes from physicians’ and institutions but maybe some commentary on how access is going into simplification. Thank you.

Tony Hooper

Analyst · Carter Gould from UBS Equities

Okay, Carter. So, it’s a great indication to have to expand the label we estimate there’s about one hundred thousand multiple myeloma patients in the U.S. that potentially could benefit from the product. Because it’s a Part B product I don’t see the prescriptions as tightly as I do with the Part D products. So we tend to look back about six to eight weeks in arrears. It is clear that there’s a large number of patients who could benefit from this the feedback has been good. The buy end probably accounts for about $30 million in the quarter, which we expect to burn out quite quickly. But everything we’ve heard to date has been positive.

Operator

Operator

And our next question is from the line of Matthew Harrison from Morgan Stanley.

Matthew Harrison

Analyst · Matthew Harrison from Morgan Stanley

Great. Good afternoon. Thanks for taking the questions. I just wanted to ask the question on Parsabiv if I could I understand the financial and sort of growth prospects for the next year or two while the product outside of the bundle. Maybe you could just talk to us about what happened in this product and how you think about it as potentially longer-term growth driver once it gets added into the bundle and what the scenarios are for that? Thank.

Bob Bradway

Analyst · Matthew Harrison from Morgan Stanley

That would be tough to calculate that. As you know the dapple will run for a minimum of two years CMS will do a full evaluation of the benefit of the drug. We’ve looked at our head to head trial, we feel that was fairly beneficial from an efficacy perspective. We also believe because of the PPI we line administration during dialysis that adherence will improve. And by definition the real world situation will deliver a higher level of value to both the patients and the dialysis units. And therefore it’s not an and all it’s really evaluating the benefit the drug brings and then how that is calculated into the future bundle going forward post a dapple.

Operator

Operator

And our next question is from the line of Kennen MacKay from RBC Capital Markets.

Kennen MacKay

Analyst · Kennen MacKay from RBC Capital Markets

Thanks for taking the question. Maybe another one for Tony. I was just wondering if you could elaborate, just what was going on with Aranesp surrounding the competition at some of the smaller providers. And then on the long-term guidance wondering if you’re accounting for HIF prolyl-hydroxylase inhibitors in the coming years here. Thank you.

Tony Hooper

Analyst · Kennen MacKay from RBC Capital Markets

Okay. So Aranesp, as you know, is bifurcated into a whole lot of pieces more than half of our business is outside the United States where the business continues to be fairly stable other than foreign exchange. Inside the U.S. it is divided between the dialysis nephrology business the hospital nephrology business and the oncology areas. Oncology has been declining for some time, so we see no change there. In the nephrology dialysis there has been a movement from a competitor a long acting competitor from FMC that has now moved into some of the IDOS and the MDOS and some of the decline you are seeing, we do have volume and shape contract with a few of these people and we will continue to fight account by account. And then on the nephrology hospital there’s a strange compare versus first quarter 2017 which included a large clinical trial purchased from a competitor.

Operator

Operator

And our next question is from the line of Ronny Gal from Bernstein.

Ronny Gal

Analyst · Ronny Gal from Bernstein

Hi everybody and thanks for squeezing me in. Tony I’m afraid this is one as – around the PCSK9. As we think about the contracts you try to sign out with the payers. Are you guys looking for open access, are you looking to close the card with a single word, or is your competitor interested in doing that and you’re following him. And second, you kind of mentioned the issue around how low this one needs to go with LDLC. And I was wondering if Sean can comment on the GEM article showing kind of like feeding off the benefit when you start a patient below 100 LDLC.

Tony Hooper

Analyst · Ronny Gal from Bernstein

So, I think we’ve always said that we would always want to have a situation where the physician has a choice on behalf of the patient. So I would always advocate for having an open formerly. We do talk consistently about looking for ways and means to have access for this high risk patient population. There’s about 3.4 million patients in the high risk population. We think a very, very small percentage a single digit penetration has been made in that population to date. And then I’ll let Sean talk about the scientific discussion around lowering LDL.

Sean Harper

Analyst · Ronny Gal from Bernstein

Yes. So I’m familiar with the GEM article that you were referring to that was just published it’s a meta-analysis. I’d point you to the accompanying editorial, which I thought was pretty good at outlining some of the likely confounding that occurred in that meta-analysis. The problem with these meta-analyses is when they go back in time 20 plus years and look at mortality. They’re very confounded by the case fatality rates that occur when people are hospitalized in the studies or experienced heart attack and stroke for example. So if you go back to for example the 4S study or Western Scotland studies the case fatality rate for a heart attack back in those days was like 30%, now it’s 4%. So you really end up with a very confounded analysis which says, well gee, when you start with a high LDL and you lower it kind of to a mid range you get this big benefit on mortality. Well that’s just what they were doing back then because there were no statins. And so people came in at very high LDL levels and they got reduced. And nowadays they come in at much lower LDL levels and it’s virtually impossible to demonstrate a statistically significant reduction in mortality, which has not happened in them in a long time and with a lowering trials. So I think that it’s very confounded, I think the editorial speaks to most of that and also just talks about shouldn’t we pay attention to the biology in our understanding holistically about how these products work and the data that emerged from all the studies that have happened in this field whether they be with statins or products like ezetimibe or now the PCSK9 inhibitors. The overall clear picture is that no matter where your LDL starts if you lower it substantially in a patient who’s at high risk, you’re going to really going to get a very large risk reduction. It is true that if a patient starts at a high LDL they have a higher risk because LDLs are risk factors. So in absolute terms you get a little bit more benefit for treating patients who have higher LDLs. But the relative risk reduction appears to be consistent across trend and the highest quality data show a very clear picture of lower is better without any safety concern. So that’s my comments on it.

Tony Hooper

Analyst · Ronny Gal from Bernstein

As of going past 6:00 PM on the East Coast. Why don’t we take two last questions after which Bob will make some closing comments.

Operator

Operator

Certainly. Our next question is from the line of Salim Syed from Mizuho Securities.

Salim Syed

Analyst · Salim Syed from Mizuho Securities

Yes. Hi, great guys. Thanks for the question. I just had one on Repatha. So there’s a ACC treatment guidelines some people are expected to come out this year at ACC Conference 2018 that’s November I believe. Do you have that same view? And then how do you expect – when you expect to come out of that in terms of practical incremental revenue opportunity for Repatha, they lower the target LDL levels. Thank you.

Bob Bradway

Analyst · Salim Syed from Mizuho Securities

I just comment that I think you’re right that this sort of general expectation is that they do around the EHA time frame and at this point one assumes that they’re not going to be waiting around for another data set that I can think of to look at lowering land. So I think it’s pretty likely that they’ll come out. And I think that if you look at the pathway update that was done some months ago likely is kind of indicative directionally of where they’re likely to go as the data has accumulated.

Tony Hooper

Analyst · Salim Syed from Mizuho Securities

And then from a revenue perspective, I would imagine it would be very difficult for payer to have utilization and management criteria that defer to the guidelines that are published by the HA and the ACC.

Operator

Operator

And our next question is from James Birchenough from Wells Fargo Securities.

Unidentified Analyst

Analyst · Wells Fargo Securities

Good afternoon. Thanks for squeezing us in again. This is Nick in for Jim. Just going back to CAR T can you comment on Amgen’s investment in the space with respect to helping commercially ready as opposed to academic components such as access, clothes manufacturing systems? And then for solid tumors many of you to get success with CAR T you’ll need to take a combination approach. Can you share that view? Thank you.

Sean Harper

Analyst · Wells Fargo Securities

Well let me answer the second question first. I think that – I believe that in most disease settings with whether you’re dealing with the CAR T or the buy specific T cell engaging type technology particularly in solid tumor settings but even in some settings such as lymphoma. People will hypothesize that there could be additive or synergistic effects between checkpoint inhibition and the use of piece kind of targeted antigene focused approach. So I think time will tell but you can expect to see many of these agents developed where in arm and in the clinical trial will be to combine the product with a checkpoint inhibitor in addition to looking at its activity alone. I hope that’s answer that part of the question. And Tony I think there was a component of the question having to do with kind of the more of the commercial landscape. I mean, these are Phase I, these are – we’re just getting ready to started enrolling the first patient in our first CAR T program in Phase 1. We’re certainly working with Tony’s organization but at this early stage at this point.

Tony Hooper

Analyst · Wells Fargo Securities

And Nick I’m not sure as well as you’re referring to the manufacturing but anyway you can follow up with Arvind and his team who were here for a while. We didn’t get to the full breadth of your question. Anyway let me just wrap up by thanking you all for joining the call. As you can see we’re off to a good start here at the first quarter of 2018. We think we’re in a strong position heading into the balance of the year. And we’re feeling confident about the long-term outlook for growth of the company. So we look forward to joining with you again here after the second quarter. Thank you.

Bob Bradway

Analyst · Wells Fargo Securities

Well thanks everybody. Thanks, Inn.

Operator

Operator

Ladies and gentlemen, this does conclude Amgen’s first quarter 2018 financial results conference call. We thank you greatly for your participation. You may now disconnect.