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PRELIMINARY TRANSCRIPTAMGN - Q1 2016 Amgen Inc Earnings Call

EVENT DATE/TIME: APRIL 28, 2016 / 9:30PM GMT

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C O R P O R A T E P A R T I C I P A N T S

Arvind Sood Amgen Inc - VP of IR

Bob Bradway Amgen Inc - Chairman and CEO David Meline Amgen Inc - CFO

Tony Hooper Amgen Inc - Head of Global Commercial Operations

Sean Harper Amgen Inc - Head of Research and Development

P R E S E N T A T I O N

Operator

My name is Jake Wong and I will be your conference facilitator today for Amgen's first-quarter 2016 financial results conference call.

(Operator instructions)

I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may begin.

Arvind Sood - Amgen Inc - VP of IR

Thank you, Jake. Good afternoon, everybody. I would like to actually begin by extending my gratitude to all of you for having to deal with the

deluge of earnings reports from multiple companies reporting today. I appreciate you being on our conference call to review our operating

performance for the first quarter of 2016.

We're off to a great start for the year and to review our progress, Bob Bradway, our Chairman and CEO, will lead the call with a strategic overview

Our CFO, David Meline, will then review our quarterly results and update you on our guidance for 2016. Tony Hooper, our Head of Global Commercia

Operations, is here to discuss our product performance during the quarter, followed by our Head of R&D, Sean Harper, who will provide a pipeline

update.

We will 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 and

discussion today, we may make certain forward-looking statements and actual results may vary materially.

So with that, I would like to turn the call over to Bob. Bob?

Bob Bradway - Amgen Inc - Chairman and CEO

Thank you, Arvind, and let me also thank our listeners for joining the call. As Arvind said, we're off to a strong start in 2016 with 10% revenue growth

and 17% adjusted earnings-per-share growth in the first quarter. Our sales were strong in the US and internationally and that was true broadly

across our products.

As you can see from these results, we've put the Company in a strong position to manage competition for our legacy products while investing fo

growth with our newly launched and late stage pipeline products. Last year as you know, we had six launches in the US. We expect these products

and especially Kyprolis and Repatha to pave the way for our long-term growth. We'll talk more about these launches and our priorities for them

on this call.

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If last year was a year of launches in the US, this will be a year of launches for us internationally as we take Repatha, Kyprolis and our other new

products into countries around the world. In total this year, we are expecting on the order of 80 new launches across our countries and products

For example, Repatha is launching now in Japan, Brazil, in multiple countries in Europe, and the early signs are good. Similarly, Kyprolis is off to a

strong early start in its first markets in Europe.

Our oncology and cardiovascular franchises received a lot of visibility last year owing to the flow of data in our product launches in these areas

This year we expect attention to focus on our other franchises as well as our pipeline advances with important new opportunities. In bone health

for example, our Romosozumab opportunity is coming into focus with positive Phase 3 data.

In nephrology, we expect approval later this year for Parsabiv, a therapeutic for dialysis patients and we expect pivotal data in neuroscience for

our migraine antibody, AMG 334. In inflammation, we look forward later this year to establishing with the FDA that our adalimumab molecule is

indeed, biosimilar to Humira.

And while I'm speaking about our biosimilars programs, I'd also remind you that we expect to submit our bevacizumab or Avastin biosimilar file

to regulators this year and to have Phase 3 data for our trastuzumab or Herceptin biosimilar as well.

Our transformation efforts are well underway and delivering results. This includes cost savings which David will discuss but also improved speedto market and speed in the market. And these attributes are every bit as important as cost savings as we grow our Company with new products

and new territories and adapt to the changing environment for our industry.

Finally we've designed our capital allocation strategy to deliver value for shareholders through both an attractive return of capital and dividend

and buybacks and vigorous investment for long-term growth. This is an exciting time in the field of biology with promising clinical opportunities

and breakthroughs arising in many of our areas of interest.

So with a strong balance sheet and a long-term investment outlook, we will continue to look for the most promising internal and externa

opportunities to advance. To underscore our prior comments on this topic, our emphasis will be on focus and capital discipline as we do this.

Before turning to David, let me just congratulate my colleagues around the world for the quality of their execution and a very strong start to the

year. David?

David Meline - Amgen Inc - CFO

Thanks, Bob. Turning to the first-quarter financial results on page 6 of the slide deck, we are pleased with our strong performance driven by continued

momentum across much of our product portfolio. Total revenues at $5.5 billion grew 10% year-over-year. Overall product sales increased 7%,

reflecting continued strong performance from our growth products which more than offset the impact of competition on our legacy products,

EPOGEN and NEUPOGEN.

Other revenues at $288 million increased $129 million versus the first quarter of 2015. Other revenue benefited both from an upfront partne

payment for a licensing transaction representing almost 40% of total other revenue for the quarter as well as higher Ibrance royalty income.

Total revenue and product sales were impacted 1% unfavorably due to foreign-exchange changes. Adjusted operating income at $2.9 billion grew

17% from prior year. Adjusted operating margin improved to 54.6% for the quarter, reflecting continued growth and progress from our transformationinitiatives across all operating expense categories. As in prior years, our operating margin will likely be lower in the remaining quarters of the yea

driven by the timing of expenses.

In 2016 we remain on track to deliver over $400 million of gross efficiency savings from the transformation versus prior year. This enables continued

investment in our pipeline and launch activities while delivering solid profitability.

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On an adjusted basis, cost of sales as a percent of product sales at 13.5% improved by 1.6 points, driven by manufacturing efficiencies, higher ne

selling price and lower royalties. Research and development expenses at $858 million were relatively unchanged in the first quarter of 2016 versus

last year. SG&A expenses increased 11% on a year-over-year basis as increased commercial investments in new product launches were enabled by

savings from transformation and process improvement efforts.

In total, adjusted operating expenses increased 3% year over year, including a favorable foreign exchange impact of approximately 1 percentage

point. Other income and expenses were relatively flat on a year-over-year basis at $144 million in the quarter as higher interest income was offse

by higher interest expense.

The adjusted tax rate was 18.9% for the quarter, a 1.9 point increase versus Q1 of 2015. This increase was primarily due to the unfavorable tax

impact of changes in the geographic mix of earnings and a state audit settlement in the same quarter of last year. These increases were partially

offset by the adoption of accounting standards update 2016-09, a new accounting standard that impacts how certain share-based compensation

tax expense is recognized.

These impacts were previously reported on the balance sheet as a change in shareholders' equity. The new rule requires these impacts to be

recognized in the income statement and thus have a tax rate impacts. Future tax rate impacts will depend on the movement in our stock price

between when we grant share-based compensation and when it vests.

The Q1 benefit of this change adds approximately $0.09 to our adjusted earnings-per-share. Adjusted net income increased 15% and adjusted

earnings per share increased 17% year over year.

Turning next to cash flow on the balance sheet on page 7. Free cash flow was $1.8 billion, an increase of $400 million over last year. We deployed

$0.7 [billion] to repurchase 4.6 million shares in the quarter at an average price of $147 per share. And are onset to achieve total share repurchase

for this year in the range of $2 billion to $3 billion. Additionally our first-quarter dividend increased to $1 per share, an increase of 27% of last year

At the end of the first quarter, we had $4.2 billion remaining on our Board-authorized share buyback program and are on track to deliver on ou

capital allocation commitments to shareholders. Cash and investments totaled $34.7 billion, an increase of $7.6 billion from last year's first-quarte

level. This increase reflects strong net cash flow and our first-quarter debt issuance of $2.9 billion of which approximately $2 billion will be used to

repay debt maturities over the balance of this year.

Our debt balance stands at $34.3 billion as of March 31 of this year. Our total debt portfolio has a weighted average interest rate of 3.7% and an

average maturity of 11 years.

Turning to the outlook for the business for the remainder of 2016 on page 8, we remain on track with our plans to continue investing to grow the

business while transforming to a more agile and efficient operating model. Today we are increasing our 2016 guidance which reflects solid Q1

performance from revenue and expense as well as a revised tax outlook.

With this background, our 2016 revenue guidance is now $22.2 to $22.6 billion versus prior guidance of $22.0 billion to $22.5 billion. And our

adjusted earnings-per-share guidance is now $10.85 to $11.20 a share versus prior guidance of $10.60 to $11. In addition, we now expect our

adjusted tax rate to be 19% to 20%, including the impact of the previously mentioned accounting standards update, versus prior guidance of 19.5%

to 20.5%. Finally we expect to invest capital expenditures of approximately $700 million this year.

This concludes the financial update. I will now turn the call over to Tony.

Tony Hooper - Amgen Inc - Head of Global Commercial Operations

Thank you, David, and good afternoon folks. You'll find a summary of our sales performance for the first quarter on slide 10. As Bob said, we had a

great start with global product sales in the first quarter growing by 7% year over year. Our US business delivered 9% year-over-year growth and

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sales growth in our international business was negatively impacted by 5 percentage points due to foreign-exchange. Excluding the foreign-exchange

impact, our international business was up 7% year over year.

I will structure my comments in three categories today. Performance in our growth products, how we are managing the lifecycle of our maturebrands and conclude with an update on the performance of our newly launched products. First our six growth products: Prolia, XGEVA, Vectibix

Nplate, Sensipar and Enbrel. Aggregated (inaudible) $3 billion in sales or over 50% of the first-quarter sales growing 20% year-over-year. Sustaining

their growth continues to be priority for us.

Let me start with Prolia and XGEVA which are now annualizing at approximately $3 billion per year. Prolia grew significantly at 29% year-over-year

Continued share gains drove growth in both the US and Europe, although with 25% year-over-year unit demand growth in both regions. We saw

the typical seasonality in the first quarter.

In the US, our direct-to-consumer promotional efforts continue to drive increasing levels of new-patient adoption and we are sustaining repeat

injection rates of over 65%. We expect the continued growth from Prolia to come for years.

XGEVA grew 11% year over year. Unit share increased about 3 percentage points over last year in both the US and Europe. The first quarter was

probably impacted by increased levels of purchasing by some large end customers in the US which we expect to burn off in the next quarter. Wecontinue to focus on XGEVA's superior clinical profile versus the competition and look forward to potential new indications which will drive sustained

long - growth.

Turning to Vectibix and Nplate, unit demand growth drove double-digit gains year-over-year across both products. For Victibix, we continue to

make solid inroads into earlier lines of therapy in both the US and Europe.

Sensipar grew 10% year over year driven by net selling price as well as unit growth in the US and Europe. With sales annualizing around $1.5 billion

Sensipar remains a growth driver. We look forward to adding Parsabiv as another treatment option for patients with secondary hyperparathyroidism

Our regulation findings for Parsabiv are currently under review in both the US and Europe.

Let me now turn to Enbrel. Enbrel grew 24% year-on-year due to changes in net selling price and inventory, which was partially offset by competition

As a reminder, net selling price change comprised several components, including list price increases as well as rebates we provide to payers and

the impact of (formry) decisions.

In the third quarter 2016, inventory was at a normal level. The year-over-year inventory growth is as a result of prior-year dynamics. The climbs in

inventory levels in the first quarter last year make for an approximately $100 million favorable comparison this quarter. As we think about the

second quarter this year, we expect to see a reverse effect of a similar magnitude. In other words, the significant inventory build in the second

quarter of 2015 will create an unfavorable comparison assuming inventory levels remain normal next quarter.

Turning to underlying performance for Enbrel, we saw 14% year-on- year growth in the rheumatology segment for the first quarter and Enbre

held quarter-over-quarter value share at 28%.

In dermatology, competition from new entrants, primarily nonbiologics, helped drive year-on-year second growth of 29%. Enbrel's share in

dermatology declined 1 percentage point quarter over quarter to 21%. If you'll recall, rheumatology comprises about 80% of Enbrel sales. Given

Enbrel's exclusivity through 2029, it remains a critical growth driver that we are continuing to invest behind.

Let me now turn to how we're managing the lifecycle of our mature brands, starting with our ESA products. Aranesp sales increased 11% year ove

year, driven by [15%] unit growth. In the US we are successfully transitioning our medium size and independent (inaudible) centers from EPOGEN

to Aranesp. Aranesp now represents over 70% of ESA's share of these providers.

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International sales were negatively impacted by pricing pressures and foreign exchange rates. EPOGEN declined 44% year-over-year. About one-third

of this decline is a shift from EPOGEN to Aranesp in the dialysis setting I mentioned above. Most of the reigning decline comes from the shift from

Amgen ESA to Macera (inaudible).

We understand that Prosinias, which recommends about one-third of the US dialysis business has converted over 70% of their patients to Macera

If you remember, we have compact with DaVita which represents another one-third of the dialysis business through 2018 to purchase at least 90%

of their ESAs from Amgen. I'd like to point that we also do not expect biosimilar competition EPOGEN in 2016.

NEUPOGEN declined 13% year over year and 19% quarter for quarter with the comparative landscape playing out as we generally expected.

NEUPOGEN exited the quarter with a 64% share of the short-acting [set] segment which now consists of [Zaggio], GRANIX and Leukine.

As we said before, we'll continue to compete account by account as competition intensifies. We continue to emphasize the value of NEUPOGEN

built on its track record of safety, efficacy and reliable supply.

Neulasta grew 4% during the quarter. Unit growth of 3% included purchases by some large US end customers which we expect to burn off nex

quarter.

Let me now turn to our launches, beginning with the Neulasta Onpro kit. The Neulasta Onpro kit has been an extremely successful launch achieving

about one-third share of Neulasta units in the first quarter and approaching $1 billion in cumulative sales in the 12 months since launch. Patients

undergoing myelosuppressive chemotherapy regimens are at-risk of serious infections. One of the biggest challenges physicians face in preventing

these infections is patient compliance.

Both ensuring patients get the Neulasta injection after each course of chemo and at the right time, 24 hours after chemo. These are critical step

in order to ensure maximum benefit of Neulasta. With the Neulasta Onpro kit, we're able to address this important unmet need. This innovation

also provides meaningful differentiation versus the tradition free-fold syringe and potential future competitors.

We also see the compliance rates improving with the use of Neulasta Onpro based on patient level data. This is a great example of our strategy to

identify and develop innovative delivery systems to improve the patient experience. By all measures, this is a highly successful launch and the

value it brings to patients and the healthcare system is translating into strong performance.

We remain focused on increasing adoption to benefit more patients. Kyprolis grew 20% year over year on a sequential basis. US unit growth was

offset by unfavorable changes to the inventory and to net selling price. The addition of [endeva] data, which demonstrated superiority versus

[velkay] to the US label in January further solidifies Kyprolis's profile as a backbone of multiple myeloma therapy. We expect sales to continue to

grow as we treat more second-line patients and they stay on therapy longer to achieve deeper and more durable responses.

In markets outside the US, we're making good progress with our launches. Initial results have been very positive as we bring this important therapy

to these patients. [Lunsida] continues to increase patient penetration in the US and launches are underway across Europe as reimbursement is

secured. Sean will discuss developments of our bi-specific antibody platform in a moment.

IMLYGIC, our Oncolytic immunotherapy for metastatic melanoma is currently indicated as monotherapy in the US Europe and is playing an importan

role in addressing the needs for the small patient population. We believe that true potential for IMLYGIC lies in combination with poli-immunotherapie

across different tumor types.

Turning now to Repatha, which I continue to believe is one of our largest opportunities. I'm pleased with our competitiveness to date. Our robus

clinical development program clearly demonstrated Repatha's ability to deliver intensive and predictable LDL-C reduction.

This message continues to resonate well with physicians and coupled with strong execution in the marketplace we continue to lead prescribing

in the US (technical difficulty) data. In Europe reimbursement are negotiations on track and we are in early launch in several countries, including

Germany, Spain, the Netherlands and Scandinavia.

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In Japan we have now received pricing approval and launch activities with our partner Astellas are well underway.

Before handing over to Sean, I thought I would provide some color on the Repatha launch. In my personal experience, I have seen a number of

examples of successful but high-value slow-ramping products that share a few common traits with Repatha.

First, these products often contribute to changes in treatment paradigms such as new mechanism of action and new routes of [evanstration]. In

the case of Repatha, [innovision] of PCSK9 is a novel mechanism and it is the first injectable biologic addressing chronic cardiovascular disease. I'm

excited about the prospect of launching the Repatha monthly dosing option later this year, reducing the number of required injections and creating

another potential point of difference from the competition.

Second, these products often have significant developing programs that improve the product profile, expand their patient pools or extended

duration of therapy over time. With Repatha, our (inaudible) study in (inaudible) patients was very well received by physicians at the recent American

College of Cardiology meeting.

Our [currently] imaging study will read out later this year and was designed to demonstrate that Repatha reduces patients' [plog] burden. And

most significantly, of course, we expect the readout of a large 27,500 patient outcomes trial later this year, which we expect will establish a clea

benefit in cardiovascular outcomes based on Repatha's profound effect on lowering LDL cholesterol.

Lastly access and reimbursement [hurdles], while intense, should be overcome with a demonstration of superior clinical benefits versus the curren

standard of care. We expect to establish this with Repatha through the outcome study I just mentioned. You might have seen this dynamic

successfully play out for (inaudible) as they displaced warfarin.

I am unwavering in my commitment and in the belief of Repatha. We will continue to work with payers to improve access to Repatha for appropriate

patients and expect its strong value proposition to benefit patients with [ASCBD] who are at risk of heart attack or stroke.

In closing, I'm pleased with our execution this quarter and our strong start to the year. We've maintained focus on our growth brands while defending

our mature portfolio and launching new products. We recognize that our launch products are an important long-term value driver and are working

relentlessly to make them a success.

Let me close by recognizing that none of this would have been possible without the dedication of our staff and thanking them for their commitmen

to delivering to patients. Let me now pass to Sean.

Sean Harper - Amgen Inc - Head of Research and Development

Thanks. Good afternoon. We've made a lot of exciting progress in Q1 as we continue to advance our pipeline of innovative programs. I'll begin my

remarks with our cardiovascular franchise starting with Repatha. Statin-associated muscle symptoms represent a major unresolved challenge to

the treatment in patients with cardiovascular disease and often result in the use of therapies that provide less LDL-cholesterol reduction than

desired. In our recently completed Phase 3 study, [Galos 3], we evaluated Repatha and ezetimibe in a group of patients whose statin intolerance

was verified by rigorous blinded statin re-challenge where only those patients that experienced muscle-related side effects on statin, but not on

placebo, were studied.

As presented at the ACC meeting and simultaneously published in the Journal of American Medical Association, the study demonstrated thatRepatha resulted in a significantly greater reduction in LDL cholesterol after 24 weeks as compared to ezetimibe with low levels of muscle-related

adverse events. We believe this is an important result for those high-risk patients that are unable to effectively managing their LDL-cholesterol due

to muscle symptoms from statins.

Looking ahead as Tony mentioned, we continue to look forward to the results of our coronary imaging study and cardiovascular outcome studie

in the second half of this year. We also continue to work closely with regulators on their reviews of our Repatha monthly dosing option.

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Feedback from cardiologists on our innovative myosin activator Omecamtiv mecarbil, has been consistent that we have a very compelling mechanism

of action in Phase 2 data set. We are currently working with our partners at Cytokinetics and Servier, as well as global regulators to define a potentia

path to Phase 3 outcome studies.

Turning to oncology, our Phase 3 open label study evaluating BLINCYTO versus standard of care in patients with (technical difficulty) relapsed o

refractory ALL was stopped at a prespecified interim analysis after successfully achieving the primary endpoint of the overall survival. This is a firs

for an immunotherapy in this population and we look forward to discussions with regulators as we seek convergence to full approval.

In Q1, we also filed an sBLA for BLINCYTO in the US to include new data supporting the treatment of pediatric and adolescent patients with ALL

We feel BLINCYTO could be an important treatment option for younger patients, potentially avoiding the complications later in life such as secondary

malignancies that can arise with the use of cytotoxic chemotherapies.

We are advancing our bispecific T-cell engager or BiTE platform including AMG 330 which continues to enroll patients in its Phase 1 dose escalation

study. Recall that AMG 330 is our (technical difficulty) for Acute Myelogenous Leukemia or AML. AML remains an area of profound unmet medica

need. Despite adult AML being about four times as prevalent as adult ALL and with a very poor prognosis, there have been no significant advance

approved in the last 20 years.

Staying with our immuno oncology platforms, we recently initiated enrollment in the Phase 3 portion of our melanoma study of IMLYGIC in

combination with KEYTRUDA, Merck's PD-1 inhibitor. And we look forward to presenting the results from the Phase 1B portion of this study at the

upcoming ASCO meeting.

We also recently presented some encouraging first-in-human data at the American Association for Cancer Research annual meeting from one o

our early stage immuno-oncology programs, AMG 820. This is our antibody against colony stimulating factor one receptor also known as C femmes

which simulates the activation of tumor associated macrophages.

There is great interest in the role that tumor-associated macrophages play in tumor immunosuppression and we're hoping to lead this field with

820, which is now enrolling patients in a Phase 1-2 study in combination with KEYTRUDA in advanced solid tumors. Before I leave oncology, I would

note we continue to have productive interactions with regulators in Europe on the Kyprolis endeavor submission.

And I'm also pleased to announce that our Phase 3 study of XGEVA versus zoledronic acid for the prevention of skeletal-related events in patients

with newly diagnosed multiple myeloma has completed its enrollment. This is an event-driven study and based on the current event rate we

estimate the data will be available in the second half of this year.

In bone health we were pleased to report, along with our partners at UCB, the positive results from two Phase 3 Romosozumab studies in Q1. Mos

importantly, our placebo-controlled pivotal fracture study met both of its primary vertebral fracture end points as well as the important secondary

endpoint of clinical fracture reduction. This latter endpoint consists of symptomatic vertebral fractures plus non-vertebral fractures, an endpoin

increasingly recognized by physicians, payers and regulators as these are the symptomatic fractures that can be life altering.

Our Phase 3 study of Romosozumab in men with osteoporosis also successfully completed in Q1 with Romosozumab treatment resulting in

significant gains in bone mineral density versus placebo. We look forward to our preBLA meeting with FDA as we pull together our initial filing

package in the US. We also await the results from the event-driven fracture study evaluating Romosozumab in comparison to a [lendernade] which

we expect to see in 2017 and will be part of our European filing.

Switching to neuroscience, we had the opportunity to present the 52-week data from our Phase 2 episodic migraine study with our CGRP recepto

antibody AMG 334 at the American it Academy of Neurology meeting earlier this month.

After one year of treatment with the 70 milligram monthly dosing regimen, more than 60% of patients experienced at least a 50% reduction in

their monthly migraine days and about 20% of patients had no migraine days in month 12. These are patients that were having an on the order o

eight migraine days per month so this is quite a clinically meaningful result.

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We believe the efficacy, tolerability and administration profile of AMG 334 could be an attractive option for migraine patients considering the lack

of well-tolerated prophylactic options currently available. We are rapidly advancing this program through the clinic with our partners at Nevarez

We now expect to have the results from our Phase 2-B chronic migraine study midyear and we intend to use this study to potentially gain anindication in chronic migraine in our initial BLA filing. We've also completed now enrollment in both of our Phase 3 episodic migraine studies and

expect the results from both of these in the second half of this year. Also in migraine we believe that AMG 301, our path-one receptor antibody

could complement AMG 334 and we continue to progress this asset through Phase 1.

In other regulatory activities, we continue to work with global regulators on their review of Parsabiv, our novel intravenous calcimimetic for the

treatment of secondary hyperparathyroidism in patients on hemodialysis. FDA has also accepted our sBLA for the expanded use of Enbrel to trea

pediatric patients with chronic severe Plaque Psoriasis.

Finally with several pivotal data sets and regulatory decisions ahead of us, we have a lot to look forward to this year and I'd like to take a momen

to thank all of my colleagues at Amgen for their unwavering focus on delivering innovative new medicines for patients in need. Bob?

Bob Bradway - Amgen Inc - Chairman and CEO

Okay. Thank you, Sean. Let's turn it over now to questions. And, Arvin, why don't you remind our callers of the procedure.

Arvind Sood - Amgen Inc - VP of IR

Yes, Jake, if you go ahead and open it up for Q&A and review the procedure for asking questions, please.

Q U E S T I O N S A N D A N S W E R S

Operator

(Operator instructions)

Matthew Harrison, Morgan Stanley.

NEW SPEAKER

Just a couple for Tony. You mentioned to customer purchase for lesser and can you tell how large they were and then second maybe if you could

expand around your comments for Repatha. I think it's our understanding that 70, 80% scripts are and at the pharmacy. What's your view on what

needs to change to lower that rate? And how should we think about the change that outcomes data come if positive could have there and is there

a rate, a hazard ratio for example in the outcomes data that you think would cause a significant shift in some of those utilization management

criteria?

NEW SPEAKER

Okay. On the large customer and user purchases for achieve and Neulasta. In the range of 30 million 30,000,000 to 50 meters but not a large amoun

but they were clearly burnoff during the second quarter. When I look at Repatha it is about a 77% rejection rate not abandoned mint that's happening

at pharmacy so a lot of the prescriptions are being denied because they don't quite fit the prior up which is been required. Talking to cardiologis

it's clear they are extremely frustrated at the moment because the patients they are sending in or appropriate patients who are not being properly

managed on tolerated Statin at the moment. We're spending quite a bit of time with payers at the moment and helping see what I would imagine

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the unintended consequences of a rather only as paper-based system which is resulting in some new patients not getting access to drugs when

they said. A bit more discussion people understand the importance of getting appropriate patients on drug. I think some of the question in term

of narrowing the population is around what will the outcome show. And there's no doubt in my mind that once we have clinical proof that this

drug actually results not only in lowering LDL but in actually reducing the risk of heart attack and stroke that more patients will gain access to thedrug.

NEW SPEAKER

Let's go within us question please.

NEW SPEAKER

Geoff Meacham, Barclays.

NEW SPEAKER

Good afternoon. Thanks for taking my question. I just wanted to talk a little bit about Romo, looking at the non- retrieval fracture data do you think

this could be a big variance competitively and what's the outlook for the European filing based on the PMO data? Do you think there is a risk tha

secondary endpoints may have to be hit on that? Thank you.

NEW SPEAKER

Thanks, Jill. Sean, what you take this question.

NEW SPEAKER

In terms of results the second part of the question relates, I think to the ability to file the data sent in Europe and we do believe that data will suppor

registration as is in Europe before we also planned to file both outcomes studies so we have the controlled study in which the primary endpoin

is clinical fracture that will be part of that. Part of that file. I think that when you step back there's a couple things. One is that we need to presen

this data at the appropriate scientific congresses and publish them so that the experts in the field can look at the data. Because the paradigm fo

the study design is so different than what people are used to with a three-year placebo-controlled portion rather than a one-year placebo-controlled

portion. And in the end the most important endpoint to look at with these therapeutics which again is the symptomatic grip TiVo factors plus

non-and we had quite a significant size there as well as the transition from treatment with Romosozumab onto probably are where we continue

to see benefit of Romosozumab into the second year on. Overall I think the data will be well received when people are able to look in it at some

detail.

NEW SPEAKER

Terence Flynn, Goldman Sachs.

NEW SPEAKER

Maybe first I was wondering if you could comment on the treasury notice and intercompany debt in any potential impact to your longer term tax

rate and any potential for an FDA panel on Etelcalcetide.

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NEW SPEAKER

On the first one first of all Amgen of course is not a company that is inverted so we are US-based company. And all of our debt is issued and received

from third parties so we don't see any impact on our business in terms of our ability to finance and the ability to deduct the interest expense from

our earnings so right now we don't see any impact but it's a pretty detailed and lengthy ruling so we continue to look at it but we don't foreseeany right now.

NEW SPEAKER

Terrance, this is Sean. We don't anticipate the need for an advisory an FDA advisory committee for.

NEW SPEAKER

Okay, Jake. Most of finis question for

NEW SPEAKER

Unless they are young, credit squeeze.

NEW SPEAKER

Thanks for taking my question. I just wanted to ask about Kyprolis and if you're seeing competition with or any of the other new regiments on the

market if you give color that that would be great.

NEW SPEAKER

Okay so let me answer that question. This is Tony. Clearly as I said the addition of the endeavor data to our label giving us both a doublet and triple

regimen in second line both with clinical data showing great efficacy versus the prior regimens has put us in a good position to give the patientsin second line to plus a better opportunity. The data in the market is quite shallow because we haven't looked at patient charts order. But as I look

at the orders for the first quarter, I see turn 27 continue to hold market show and third line. I see continued growth in the second line and I see the

newer entrants with very low single-digit market shares and predominantly being used and fourth line plus.

NEW SPEAKER

Corey because him off, JPMorgan.

NEW SPEAKER

Good afternoon. Thanks for taking the question. With regard to Repatha access. Assuming you get positive CVOT dated later this year what's you

understanding of the process you need to follow in order to ease current utilization management. I'm wondering how fast things could open upor if you're going to need to get the data and labor and renegotiate with payers first before you're able to have a noticeable different on that front

NEW SPEAKER

As Sean said we expect the data in the latter end of this year. Once the data becomes clear it will become public and people have to make up thei

minds what that actually means. It will be presented then in a peer reviewed publication and presented at one of the large congresses where the

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data will become clear to all the prescribing cardiologists. We of course, from a commercial perspective are not in a position to negotiate or talk

to payers about the data until the FDA has approved it in our label. In the interim however our medical affairs organization can respond to question

we received from the payers in a balanced and medical way. But I'm assuming once this becomes clear the details will clarify the unique value o

this particular product.

NEW SPEAKER

This is Trinity. I think the other comment I would make is that you may have seen that the US space guidelines for treatment of hyperlipidemia and

cardiovascular risk were recently updated and included the concept of using the PCSK9 inhibitors after stepping through some other therapeutic

options that have the cardiovascular outcomes data. It's my understanding from talking with many of the key opinion leaders who are either

involved in the guidelines or just a thought leaders in the field, there's a clear desire to update these guidelines as fast as possible when the

cardiovascular outcomes data are available. So that's an independent process from anything to do with getting direct data into the label and can

be a very important thing that payers look at when they make access decisions.

NEW SPEAKER

Jake, let's take the next question.

NEW SPEAKER

Mark Schoenebaum, Evercore ISI.

NEW SPEAKER

Maybe a question for Bob. In this environment biotech prices have obviously cut down. I'm wondering what your current feelings, Bob, are around

hostile acquisitions. Thank you very much.

NEW SPEAKER

Well, mark, I don't know that I would make any comments about hostile acquisitions but as you've heard us say before, valuations in some areas

of our track of this year than they were last year. And we have a strong balance sheet and we continue to look carefully both internally and externally

for the most attractive programs that we can advance. But we look at all range of transactions, licensing as well as every day and we consider them

each individual so I wouldn't speculate, mark, but anything more than that at this point.

NEW SPEAKER

Michael Yee, RBC Capital Markets.

NEW SPEAKER

Great, thanks. Question for Trent eight, the pivotal is coming in and is a wealth of data coming. You talked in the cast about your hypothesis you

mechanism in differentiation. Can you maybe update us on your thoughts about how you still see that playing out with more data has come out

and maybe list wanted to things we specifically see some differentiation or how that plays in the future. Thanks.

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NEW SPEAKER

Thank you, Michael. I don't think much has really changed in terms of the fact that there are fundamental scientific principles here around the

difference between a receptor antagonist and the live and. We've always felt that the receptor antagonist would be more potent and we're seeing

that play out. We've always felt that might result in a situation in which the administration profile of the product was better than it would be if alarger amounts of protein were delivered for delivery on a monthly basis in a subcutaneous delivery device. So I continue to think that it's a relative

advantage to have a more potent agent when you're trying to administer in frequent dosing subcutaneously. But whether that will really play into

being an important clinical differentiator when these products are out in the places I think it's too soon to know. Otherwise we continue to push

very hard on the product to get it to patients as fast as we can because there are about 26 million people with migraines in the United States and

among them there's somewhere on the order of 8 million to somewhere on the order of 8,000,000 to 10,000,000 who of that attempts or are

currently on and off of therapy for prophylaxis. So there's clearly a very large unmet medical need and some proportion of that population would

be inappropriate population potentially for this sort of therapeutic.

NEW SPEAKER

Joshua Schimmer, Piper Jaffray.

NEW SPEAKER

Amgen had such a strong track record advancing to Phase 3 programs through commercialization I'm curious as to what there is in the phase 2 o

earlier pipeline that your most enthusiastic to move into Phase 3 you mentioned him curious as to what else.

NEW SPEAKER

Sure. I'd like to talk about that sort of thing. Certainly Oma Campton is very exciting. We also as I mentioned have another migraine prophylaxis

antibody and of course the potential to actually develop a by specific antibody that would address both of those pathways as a product behind

that. Heart failure does remain a real focus for us and we actually are introducing a novel completely novel heart failure medicine into the clinic in

a matter of days from now which is exciting. And have quite a few early discovery level programs in that area. Cardiovascular broadly we have

some very interesting things we're working on in the early and mid-stage pipeline. And of course the bite platform has a very large number ofproducts in preclinical phases that are moving toward the clinic and we're seeing a situation in which were going to be introducing into the clinic

multiple different therapies in some cases with different targets of directed at the same hematological malignancy for example and are having to

envision some interesting multi-armed clinical trials to try to get some efficiency in the testing when we have so many things coming forward

simultaneously. So there's a lot going on. Because of everything that happened it's happening at the commercialization phase we don't get a lo

of time to talk about that and perhaps we'll have an opportunity in the upcoming business review setting to go through some of this in more detail

NEW SPEAKER

Robyn Karnauskas, CIT I.

NEW SPEAKER Thanks for taking my question. Just thinking a little bit big picture on your pathologic I think you call that a slow launch a new talking about working

with payers. How much are you willing to participate and deal with price versus say mortality outcomes. So what's the balance of lowering price

and mortality outcomes as far as opening up access. Thanks.

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NEW SPEAKER

Robin, it's Tony. Clearly as we said we bring our products to market with a clear debate and discussion around the economic value of the products

There was and extrapolated value of these drugs would actually result in production of both stroke, heart attack and early untimely death. And

think we will continue to bring this to market. In the marketplace and that can dynamic will continue over time. As we jostle for position. But I thinkwhat we bring to market at the moment is a pretty decent and acceptable value proposition to treat patients at high risk.

NEW SPEAKER

Eun Yang, Jefferies.

NEW SPEAKER

A question on. Would you bundle the payment in dialysis what do you think could be that pricing power be for the product like this, particularly

since to generate in a couple of years. Thanks.

NEW SPEAKER

That's Tony. Let me answer this one. As you know, CMS has granted a two-year period for this product will operate outside the bundle. Under the

ASP pricing method which will give CMS two years to evaluate the product value and then to make a decision how much value is put into the

bundle when the product moves from ASP into the bundle.

NEW SPEAKER

Ching Wong, the of a Merrill Lynch.

NEW SPEAKER

Thanks for taking my question. First one for Sean to talk about and outcome trial. I know you never disclose the assumption or the assumption fo

event rate but should we assume that it's probably similar to what your competitor has talked about? And secondly I have a question on the market

First year switching to you have a long-term contract with Davita what is your one third of the market with going forward?

NEW SPEAKER

I will take this into parts. Sean will take your first question and Tony can address your other? Compare

NEW SPEAKER

We both actually both we and have published papers on the design of the studies. Where there's quite a bit of detail in the way they were constructed

And in the end these studies, types of studies differ largely in the issue of how long it takes to enroll the population and what the event rate is onceyou get patients enrolled. We don't believe we would not anticipate large differences in the event rates between the two populations. But there

will be some different in event rate. And I think both companies have set their studies of so that they would be able to detect what was considered

to be a clinically meaningful minimal effect size so typically one what sets these kind of trials up so that you wouldn't miss a 20% reduction in risk

Obviously you may be looking for more but that would be the way you power the trial. There's more similarities than there are differences.

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NEW SPEAKER

Some of the answer your question on the dialysis market. You're right, the market is broken into three. Davita is responsible for about one third o

the market. We have contract with them that is exclusive and runs through 2018. Persinius who is another one third of the market on the process

of converting all of their patients. The last time they made any numbers public they were talking about just over 70% conversion to Masera. Theother one of the market is the independent, medium and small dialysis units. And that setting we have converted about 70% of the usage to

Aranesp Geoffrey Porges, Lincoln relink partners.

NEW SPEAKER

Thank you. I appreciate the question. Tony, a couple for you. Could you talk a little bit about price in Enbrel. The contribution of price. Should we

just infer that it's a difference between the growth for units and the inventory of its about 20% and could you just talk about whether that looks

to be sustainable given the market environment and on a related note could you talk about the value proposition for AMG 334. Millions of patients

out there with migraine but you can imagine payers preparing to do some of the things that they did for the pop up. How do you think you're

going to approach the value proposition that indication to avoid the really tight restrictions you've encountered.

NEW SPEAKER

Let's go back to depricing. Just to reconfirm again. What we report and will we talk about in terms of match price and really that's a combination

of the list price minus the rebates and positions you have in the marketplace. I think as a company we are acutely aware of the issues facing the

industry in the US at the moment. But Amgen's all about innovation so as we price our drugs around the pharmacoeconomic values of the products

as we bring them to market, Enbrel itself is competing in a highly competitive marketplace with several large players are competing for position

to enable patient access. At the same time the health plans and the PBMs are negotiating price concessions on large rebates to set up places tha

sell and it's because of the magnitude of these rebates that the pricing increases have become part of this overall dynamic. So it's an integrated

process flow as we go forward. Talking about 334, as Sean has said again and again this is a huge unmet medical need in the marketplace where

existing therapies have side effects that are sometimes as bad as the disease itself. Unlike most other diseases, patients with chronic migraine really

know about a. It's debilitating. It is devastating. And some of the initial research we've done have shown a much higher inclination or preparednes

to pay a co-pay because patients really want to get rid of the disease as quick as they can. I think most of the patients who are available to us have

been on therapy for some time and were able to show they've been on therapy so I'm sure will be there. But there's a large bowl is a patient who

failed consistently on existing treatment in the marketplace.

NEW SPEAKER

I'm noticing it is faster closing 6. 30 p.m. on the East Coast. Let's take two last questions.

NEW SPEAKER

Jim Burchinal, Wells Fargo Securities.

NEW SPEAKER Thanks for squeezing us in. I am in for Jim. I wanted to ask a question on the CGRP program specifically on the regular tree path as you know it's a

competitive space with four players. You have the clear lead. The first Phase 3 data readout for that frequent episodic migraine indication. However

in a chronic migraine indication it's a little less clear because others have Phase 3 programs ongoing. You're interested you just mentioned you

commented that you might use the Phase 2 data that is going to read out the Phase 2 B data in chronic migraine to support APO a. Question is,

are you do you think you will seek chronic migraine indication based on the Phase 2 B data has there been any discussion with regulators on that

Thanks.

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