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AMGN - Q1 2016 Amgen Inc Earnings Call


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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. Sean Harper. So with that. our Chairman and CEO. is prohibited without the prior written consent of Thomson Reuters. Our sales were strong in the US and internationally and that was true broadly across our products. will then review our quarterly results and update you on our guidance for 2016. We expect these products and especially Kyprolis and Repatha to pave the way for our long-term growth. 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. As you can see from these results.Chairman and CEO David Meline Amgen Inc . Republication or redistribution of Thomson Reuters content. I appreciate you being on our conference call to review our operating performance for the first quarter of 2016. Arvind Sood . David Meline.Head of Global Commercial Operations Sean Harper Amgen Inc . we may make certain forward-looking statements and actual results may vary materially.VP of IR Thank you. Our CFO. Sood. Vice President of Investor Relations. we've put the Company in a strong position to manage competition for our legacy products while investing for growth with our newly launched and late stage pipeline products. We're off to a great start for the year and to review our progress. everybody. Mr. I would like to turn the call over to Bob. and let me also thank our listeners for joining the call. Last year as you know. These slides have been posted on our website and a link was sent to you separately by email.Q1 2016 Amgen Inc Earnings Call CORPORATE PARTICIPANTS Arvind Sood Amgen Inc .CFO Tony Hooper Amgen Inc .Head of Research and Development PRESENTATION 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 | Contact Us ©2016 Thomson Reuters. who will provide a pipeline update.streetevents. 2016 / 9:30PM. All rights reserved. we're off to a strong start in 2016 with 10% revenue growth and 17% adjusted earnings-per-share growth in the first quarter.Chairman and CEO Thank you. As Arvind said. Good afternoon. Tony Hooper. AMGN .VP of IR Bob Bradway Amgen Inc .Amgen Inc . we had six launches in the US. . We will use slides for our presentation today. you may begin.PRELIMINARY APRIL 28. Arvind. Jake. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. Bob Bradway. Bob? Bob Bradway . is here to discuss our product performance during the quarter. We'll talk more about these launches and our priorities for them on this call. our Head of Global Commercial Operations.Amgen Inc . will lead the call with a strategic overview. including by framing or similar means. 2 THOMSON REUTERS STREETEVENTS | www. followed by our Head of R&D.

Finally we've designed our capital allocation strategy to deliver value for shareholders through both an attractive return of capital and dividends and buybacks and vigorous investment for long-term growth. As in prior years. To underscore our prior comments on this topic. this will be a year of launches for us internationally as we take Repatha.streetevents. Adjusted operating margin improved to 54. AMG 334. Turning to the first-quarter financial results on page 6 of the slide deck. David? David Meline . This year we expect attention to focus on our other franchises as well as our pipeline advances with important new opportunities. we look forward later this year to establishing with the FDA that our adalimumab molecule is. In total this year. Our transformation efforts are well underway and delivering results. Adjusted operating income at $2. 3 THOMSON REUTERS STREETEVENTS | www. reflecting continued strong performance from our growth products which more than offset the impact of competition on our legacy products. Repatha is launching now in Japan. Similarly. our emphasis will be on focus and capital discipline as we do this. In bone health. biosimilar to Humira. In nephrology. Other revenue benefited both from an upfront partner payment for a licensing transaction representing almost 40% of total other revenue for the quarter as well as higher Ibrance royalty income. we will continue to look for the most promising internal and external opportunities to advance. our Romosozumab opportunity is coming into focus with positive Phase 3 data. 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. 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. EPOGEN and NEUPOGEN. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. Other revenues at $288 million increased $129 million versus the first quarter of 2015. In 2016 we remain on track to deliver over $400 million of gross efficiency savings from the transformation versus prior year. For example. Before turning to David. AMGN . our operating margin will likely be lower in the remaining quarters of the year driven by the timing of expenses. reflecting continued growth and progress from our transformation initiatives across all operating expense categories. we are pleased with our strong performance driven by continued momentum across much of our product portfolio. So with a strong balance sheet and a long-term investment outlook. 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. This includes cost savings which David will discuss but also improved speed to market and speed in the market. Brazil.Q1 2016 Amgen Inc Earnings Call If last year was a year of launches in the US. . let me just congratulate my colleagues around the world for the quality of their execution and a very strong start to the year. And while I'm speaking about our biosimilars programs. we expect approval later this year for Parsabiv. Total revenues at $5.PRELIMINARY APRIL 28.CFO Thanks.Amgen Inc . This enables continued investment in our pipeline and launch activities while delivering solid profitability. for example. a therapeutic for dialysis patients and we expect pivotal data in neuroscience for our migraine antibody. Total revenue and product sales were impacted 1% unfavorably due to foreign-exchange changes. This is an exciting time in the field of biology with promising clinical opportunities and breakthroughs arising in many of our areas of interest. we are expecting on the order of 80 new launches across our countries and products. including by framing or similar means. and the early signs are good. Kyprolis is off to a strong early start in its first markets in | Contact Us ©2016 Thomson Reuters. Bob. In inflammation. Republication or redistribution of Thomson Reuters content. in multiple countries in Europe.9 billion grew 17% from prior year. All rights reserved.6% for the quarter. 2016 / 9:30PM. Kyprolis and our other new products into countries around the world. indeed.5 billion grew 10% year-over-year. Overall product sales increased 7%. is prohibited without the prior written consent of Thomson Reuters.

9% for the quarter. Other income and expenses were relatively flat on a year-over-year basis at $144 million in the quarter as higher interest income was offset by higher interest expense.6 million shares in the quarter at an average price of $147 per share. an increase of 27% of last year.5% to 20. These impacts were previously reported on the balance sheet as a change in shareholders' equity.5%.09 to our adjusted earnings-per-share. And are onset to achieve total share repurchase for this year in the range of $2 billion to $3 billion. including the impact of the previously mentioned accounting standards update. driven by manufacturing efficiencies. Finally we expect to invest capital expenditures of approximately $700 million this year. We deployed $0. we had $4. Our debt balance stands at $34. Our total debt portfolio has a weighted average interest rate of 3.9 point increase versus Q1 of 2015.Q1 2016 Amgen Inc Earnings Call On an adjusted basis. an increase of $7. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.3 billion as of March 31 of this year. 2016 / 9:30PM.2 billion remaining on our Board-authorized share buyback program and are on track to deliver on our capital allocation commitments to shareholders. an increase of $400 million over last year. As Bob said. is prohibited without the prior written consent of Thomson | Contact Us ©2016 Thomson Reuters. we now expect our adjusted tax rate to be 19% to 20%.streetevents. Turning to the outlook for the business for the remainder of 2016 on page 8. David. This concludes the financial update. In addition. Cash and investments totaled $34.60 to $11. The adjusted tax rate was 18.9 billion of which approximately $2 billion will be used to repay debt maturities over the balance of this year. Additionally our first-quarter dividend increased to $1 per share. we had a great start with global product sales in the first quarter growing by 7% year over year.8 billion. 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. I will now turn the call over to Tony. Future tax rate impacts will depend on the movement in our stock price between when we grant share-based compensation and when it vests.6 billion versus prior guidance of $22.85 to $11.0 billion to $22.2 to $22.7 billion. Turning next to cash flow on the balance sheet on page 7.20 a share versus prior guidance of $10. Today we are increasing our 2016 guidance which reflects solid Q1 performance from revenue and expense as well as a revised tax outlook. cost of sales as a percent of product sales at 13.5% improved by 1. Our US business delivered 9% year-over-year growth and 4 THOMSON REUTERS STREETEVENTS | www.PRELIMINARY APRIL 28.7 [billion] to repurchase 4. These increases were partially offset by the adoption of accounting standards update 2016-09. our 2016 revenue guidance is now $22.6 billion from last year's first-quarter level. and good afternoon folks. 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. Free cash flow was $1.6 points. including by framing or similar means. And our adjusted earnings-per-share guidance is now $10.5 billion.Head of Global Commercial Operations Thank you. . AMGN . Adjusted net income increased 15% and adjusted earnings per share increased 17% year over year. including a favorable foreign exchange impact of approximately 1 percentage point. With this background. This increase reflects strong net cash flow and our first-quarter debt issuance of $2. Republication or redistribution of Thomson Reuters content. In total. All rights reserved. we remain on track with our plans to continue investing to grow the business while transforming to a more agile and efficient operating model. versus prior guidance of 19. At the end of the first quarter. The new rule requires these impacts to be recognized in the income statement and thus have a tax rate impacts. Tony Hooper .Amgen Inc . The Q1 benefit of this change adds approximately $0. adjusted operating expenses increased 3% year over year. Research and development expenses at $858 million were relatively unchanged in the first quarter of 2016 versus last year. You'll find a summary of our sales performance for the first quarter on slide 10. a 1.7% and an average maturity of 11 years. a new accounting standard that impacts how certain share-based compensation tax expense is recognized. higher net selling price and lower royalties.

The climbs in inventory levels in the first quarter last year make for an approximately $100 million favorable comparison this quarter. 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. With sales annualizing around $1. We continue to focus on XGEVA's superior clinical profile versus the competition and look forward to potential new indications which will drive sustained long . We saw the typical seasonality in the first quarter. Given Enbrel's exclusivity through 2029. Vectibix. unit demand growth drove double-digit gains year-over-year across both products. 5 THOMSON REUTERS STREETEVENTS | www. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. XGEVA grew 11% year over year. driven by [15%] unit growth. Nplate. In the US we are successfully transitioning our medium size and independent (inaudible) centers from EPOGEN to Aranesp. Sensipar grew 10% year over year driven by net selling price as well as unit growth in the US and Europe. For Victibix. We look forward to adding Parsabiv as another treatment option for patients with secondary hyperparathyroidism. I will structure my comments in three categories | Contact Us ©2016 Thomson Reuters. The year-over-year inventory growth is as a result of prior-year dynamics. 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%. Continued share gains drove growth in both the US and Europe. including list price increases as well as rebates we provide to payers and the impact of (formry) decisions. Let me now turn to how we're managing the lifecycle of our mature brands. we expect to see a reverse effect of a similar magnitude. Excluding the foreign-exchange impact. including by framing or similar means. Prolia grew significantly at 29% year-over-year. Aggregated (inaudible) $3 billion in sales or over 50% of the first-quarter sales growing 20% year-over-year. we continue to make solid inroads into earlier lines of therapy in both the US and Europe. All rights reserved. . First our six growth products: Prolia. Let me now turn to Enbrel.5 billion. Sustaining their growth continues to be priority for us. competition from new entrants.PRELIMINARY APRIL 28. starting with our ESA products. Let me start with Prolia and XGEVA which are now annualizing at approximately $3 billion per year. If you'll recall. helped drive year-on-year second growth of 29%. it remains a critical growth driver that we are continuing to invest behind. Aranesp now represents over 70% of ESA's share of these providers. our international business was up 7% year over year. Sensipar remains a growth driver. Unit share increased about 3 percentage points over last year in both the US and Europe. Republication or redistribution of Thomson Reuters content. XGEVA. In the third quarter 2016. we saw 14% year-on. Aranesp sales increased 11% year over year. 2016 / 9:30PM. although with 25% year-over-year unit demand growth in both regions. how we are managing the lifecycle of our mature brands and conclude with an update on the performance of our newly launched products. is prohibited without the prior written consent of Thomson Reuters.year growth in the rheumatology segment for the first quarter and Enbrel held quarter-over-quarter value share at 28%. the significant inventory build in the second quarter of 2015 will create an unfavorable comparison assuming inventory levels remain normal next quarter. In other words. primarily nonbiologics.streetevents. Our regulation findings for Parsabiv are currently under review in both the US and Europe. Enbrel grew 24% year-on-year due to changes in net selling price and inventory. In the US. rheumatology comprises about 80% of Enbrel sales. Sensipar and Enbrel. Enbrel's share in dermatology declined 1 percentage point quarter over quarter to 21%. inventory was at a normal level. AMGN .Q1 2016 Amgen Inc Earnings Call sales growth in our international business was negatively impacted by 5 percentage points due to foreign-exchange. net selling price change comprised several components. We expect the continued growth from Prolia to come for years. In dermatology. Performance in our growth products. As a reminder. Turning to Vectibix and Nplate. which was partially offset by competition. Turning to underlying performance for Enbrel. As we think about the second quarter this year.

which demonstrated superiority versus [velkay] to the US label in January further solidifies Kyprolis's profile as a backbone of multiple myeloma therapy. 6 THOMSON REUTERS STREETEVENTS | www. All rights reserved. With the Neulasta Onpro kit. 2016 / 9:30PM. 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. we'll continue to compete account by account as competition intensifies. We understand that Prosinias. EPOGEN declined 44% year-over-year.Q1 2016 Amgen Inc Earnings Call International sales were negatively impacted by pricing pressures and foreign exchange rates. NEUPOGEN exited the quarter with a 64% share of the short-acting [set] segment which now consists of [Zaggio]. including by framing or similar means. In Europe reimbursement are negotiations on track and we are in early launch in several countries. I'm pleased with our competitiveness to date. Kyprolis grew 20% year over year on a sequential basis. Most of the reigning decline comes from the shift from Amgen ESA to Macera (inaudible). this is a highly successful launch and the value it brings to patients and the healthcare system is translating into strong performance. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. Republication or redistribution of Thomson Reuters content. Spain. including Germany. Unit growth of 3% included purchases by some large US end customers which we expect to burn off next quarter. Initial results have been very positive as we bring this important therapy to these patients. which recommends about one-third of the US dialysis business has converted over 70% of their patients to Macera. We believe that true potential for IMLYGIC lies in combination with poli-immunotherapies across different tumor types. This innovation also provides meaningful differentiation versus the tradition free-fold syringe and potential future competitors. NEUPOGEN declined 13% year over year and 19% quarter for quarter with the comparative landscape playing out as we generally expected. the Netherlands and Scandinavia. is prohibited without the prior written consent of Thomson Reuters. Turning now to Repatha. Let me now turn to our launches. 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. Both ensuring patients get the Neulasta injection after each course of chemo and at the right time. In markets outside the US. 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. We remain focused on increasing adoption to benefit more patients. built on its track record of safety. 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. About one-third of this decline is a shift from EPOGEN to Aranesp in the dialysis setting I mentioned above. We continue to emphasize the value of NEUPOGEN. AMGN . our Oncolytic immunotherapy for metastatic melanoma is currently indicated as monotherapy in the US Europe and is playing an important role in addressing the needs for the small patient population. beginning with the Neulasta Onpro kit. . Sean will discuss developments of our bi-specific antibody platform in a moment. we're making good progress with our launches. These are critical steps in order to ensure maximum benefit of Neulasta. One of the biggest challenges physicians face in preventing these infections is patient compliance. The addition of [endeva] data. [Lunsida] continues to increase patient penetration in the US and launches are underway across Europe as reimbursement is secured.streetevents. we're able to address this important unmet need. As we said before. 24 hours after chemo. Our robust clinical development program clearly demonstrated Repatha's ability to deliver intensive and predictable LDL-C reduction. which I continue to believe is one of our largest opportunities. GRANIX and Leukine. I'd like to point that we also do not expect biosimilar competition EPOGEN in 2016. If you | Contact Us ©2016 Thomson Reuters. IMLYGIC. We also see the compliance rates improving with the use of Neulasta Onpro based on patient level data. Neulasta grew 4% during the quarter. Patients undergoing myelosuppressive chemotherapy regimens are at-risk of serious infections. efficacy and reliable supply. This is a great example of our strategy to identify and develop innovative delivery systems to improve the patient experience.PRELIMINARY APRIL 28. US unit growth was offset by unfavorable changes to the inventory and to net selling price. By all measures.

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. [Galos 3]. our (inaudible) study in (inaudible) patients was very well received by physicians at the recent American College of Cardiology meeting. First. I am unwavering in my commitment and in the belief of Repatha. I'm excited about the prospect of launching the Repatha monthly dosing option later this year. expand their patient pools or extended duration of therapy over time.Head of Research and Development Thanks. . We recognize that our launch products are an important long-term value driver and are working relentlessly to make them a success. AMGN . reducing the number of required injections and creating another potential point of difference from the competition. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. we continue to look forward to the results of our coronary imaging study and cardiovascular outcome studies in the second half of this year. should be overcome with a demonstration of superior clinical benefits versus the current standard of care. 7 THOMSON REUTERS STREETEVENTS | www. Let me close by recognizing that none of this would have been possible without the dedication of our staff and thanking them for their commitment to delivering to patients. We also continue to work closely with regulators on their reviews of our Repatha monthly dosing option. We expect to establish this with Repatha through the outcome study I just mentioned. In our recently completed Phase 3 study.500 patient outcomes trial later this year. Before handing over to Sean. Let me now pass to Sean. In the case of Repatha. which we expect will establish a clear benefit in cardiovascular outcomes based on Repatha's profound effect on lowering LDL cholesterol. were studied. As presented at the ACC meeting and simultaneously published in the Journal of American Medical Association. including by framing or similar means. 2016 / 9:30PM. 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.Amgen Inc . You might have seen this dynamic successfully play out for (inaudible) as they displaced warfarin. Lastly access and reimbursement [hurdles]. is prohibited without the prior written consent of Thomson Reuters. I'll begin my remarks with our cardiovascular franchise starting with Repatha. [innovision] of PCSK9 is a novel mechanism and it is the first injectable biologic addressing chronic cardiovascular disease.PRELIMINARY APRIL 28. 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. We've maintained focus on our growth brands while defending our mature portfolio and launching new products. of course. Second. With Repatha. I have seen a number of examples of successful but high-value slow-ramping products that share a few common traits with Repatha. I'm pleased with our execution this quarter and our strong start to the | Contact Us ©2016 Thomson Reuters.streetevents. these products often contribute to changes in treatment paradigms such as new mechanism of action and new routes of [evanstration]. while intense. 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. the study demonstrated that Repatha resulted in a significantly greater reduction in LDL cholesterol after 24 weeks as compared to ezetimibe with low levels of muscle-related adverse events. In closing. All rights reserved. Good afternoon. In my personal experience. Republication or redistribution of Thomson Reuters content. We've made a lot of exciting progress in Q1 as we continue to advance our pipeline of innovative programs. And most significantly. I thought I would provide some color on the Repatha launch. we expect the readout of a large 27. but not on placebo. Sean Harper . Looking ahead as Tony mentioned. Our [currently] imaging study will read out later this year and was designed to demonstrate that Repatha reduces patients' [plog] burden. these products often have significant developing programs that improve the product profile.Q1 2016 Amgen Inc Earnings Call In Japan we have now received pricing approval and launch activities with our partner Astellas are well underway.

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. Switching to | Contact Us ©2016 Thomson Reuters. 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. 2016 / 9:30PM. Before I leave oncology. Republication or redistribution of Thomson Reuters content. These are patients that were having an on the order of eight migraine days per month so this is quite a clinically meaningful result. including by framing or similar means. has been consistent that we have a very compelling mechanism of action in Phase 2 data set.streetevents. AMGN . we also filed an sBLA for BLINCYTO in the US to include new data supporting the treatment of pediatric and adolescent patients with ALL. Despite adult AML being about four times as prevalent as adult ALL and with a very poor prognosis. 8 THOMSON REUTERS STREETEVENTS | www. as well as global regulators to define a potential path to Phase 3 outcome studies. This is our antibody against colony stimulating factor one receptor also known as C femmes. 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. which is now enrolling patients in a Phase 1-2 study in combination with KEYTRUDA in advanced solid tumors. there have been no significant advances approved in the last 20 years. Staying with our immuno oncology platforms. along with our partners at UCB. an endpoint increasingly recognized by physicians. payers and regulators as these are the symptomatic fractures that can be life altering. 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. All rights reserved. After one year of treatment with the 70 milligram monthly dosing regimen. In bone health we were pleased to report. which simulates the activation of tumor associated macrophages. We look forward to our preBLA meeting with FDA as we pull together our initial filing package in the US. We feel BLINCYTO could be an important treatment option for younger patients. And we look forward to presenting the results from the Phase 1B portion of this study at the upcoming ASCO meeting. 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. In Q1.Q1 2016 Amgen Inc Earnings Call Feedback from cardiologists on our innovative myosin activator Omecamtiv mecarbil. Most 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. We also recently presented some encouraging first-in-human data at the American Association for Cancer Research annual meeting from one of our early stage immuno-oncology programs. AMG 820. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. This latter endpoint consists of symptomatic vertebral fractures plus non-vertebral fractures. the positive results from two Phase 3 Romosozumab studies in Q1. . our Phase 3 open label study evaluating BLINCYTO versus standard of care in patients with (technical difficulty) relapsed or refractory ALL was stopped at a prespecified interim analysis after successfully achieving the primary endpoint of the overall survival. AML remains an area of profound unmet medical need. we recently initiated enrollment in the Phase 3 portion of our melanoma study of IMLYGIC in combination with KEYTRUDA. I would note we continue to have productive interactions with regulators in Europe on the Kyprolis endeavor submission. 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. is prohibited without the prior written consent of Thomson Reuters. 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. This is a first for an immunotherapy in this population and we look forward to discussions with regulators as we seek convergence to full approval.PRELIMINARY APRIL 28. Merck's PD-1 inhibitor. Turning to oncology. We are currently working with our partners at Cytokinetics and Servier. we had the opportunity to present the 52-week data from our Phase 2 episodic migraine study with our CGRP receptor antibody AMG 334 at the American it Academy of Neurology meeting earlier this month. Recall that AMG 330 is our (technical difficulty) for Acute Myelogenous Leukemia or AML.

please. 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.streetevents. why don't you remind our callers of the procedure. Also in migraine we believe that AMG 301. In other regulatory activities. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.Amgen Inc .Q1 2016 Amgen Inc Earnings Call We believe the efficacy.000 to 50 meters but not a large amount but they were clearly burnoff during the second quarter. our path-one receptor antibody could complement AMG 334 and we continue to progress this asset through Phase 1.000.PRELIMINARY APRIL 28. NEW SPEAKER Just a couple for Tony. 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 an indication in chronic migraine in our initial BLA filing. 80% scripts are and at the pharmacy. including by framing or similar means. 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. And. FDA has also accepted our sBLA for the expanded use of Enbrel to treat pediatric patients with chronic severe Plaque Psoriasis. We are rapidly advancing this program through the clinic with our partners at Nevarez. Morgan Stanley. On the large customer and user purchases for achieve and Neulasta. is prohibited without the prior written consent of Thomson Reuters. Finally with several pivotal data sets and regulatory decisions ahead of us. Bob? Bob Bradway .com | Contact Us ©2016 Thomson Reuters. In the range of 30 million 30.VP of IR Yes. 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. Talking to cardiologist 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. AMGN .Amgen Inc . I think it's our understanding that 70. Republication or redistribution of Thomson Reuters content. We're spending quite a bit of time with payers at the moment and helping see what I would imagine 9 THOMSON REUTERS STREETEVENTS | www. . 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. 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. Arvin. 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. 2016 / 9:30PM. 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. if you go ahead and open it up for Q&A and review the procedure for asking questions. we have a lot to look forward to this year and I'd like to take a moment to thank all of my colleagues at Amgen for their unwavering focus on delivering innovative new medicines for patients in need. Thank you.Chairman and CEO Okay. Jake. All rights reserved. Arvind Sood . Let's turn it over now to questions. Sean. QUESTIONS AND ANSWERS Operator (Operator instructions) Matthew Harrison.

Jill. AMGN . All rights reserved. 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. Barclays. Republication or redistribution of Thomson Reuters content. I just wanted to talk a little bit about Romo. One is that we need to present this data at the appropriate scientific congresses and publish them so that the experts in the field can look at the data. NEW SPEAKER Terence Flynn. . 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 the drug. including by framing or similar means. NEW SPEAKER Let's go within us question please.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 that secondary endpoints may have to be hit on that? Thank you. Sean. is prohibited without the prior written consent of Thomson Reuters. I think to the ability to file the data sent in Europe and we do believe that data will support registration as is in Europe before we also planned to file both outcomes studies so we have the controlled study in which the primary endpoint is clinical fracture that will be part of that. NEW SPEAKER Good | Contact Us ©2016 Thomson Reuters.streetevents. what you take this question.Q1 2016 Amgen Inc Earnings Call 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. Thanks for taking my question. Part of that file. Because the paradigm for 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. NEW SPEAKER Geoff Meacham. 10 THOMSON REUTERS STREETEVENTS | www. NEW SPEAKER Thanks. I think some of the question in terms of narrowing the population is around what will the outcome show. 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. NEW SPEAKER In terms of results the second part of the question relates. looking at the non. A bit more discussion people understand the importance of getting appropriate patients on drug. I think that when you step back there's a couple things. Overall I think the data will be well received when people are able to look in it at some detail.PRELIMINARY APRIL 28. 2016 / 9:30PM. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.

credit squeeze. This is Tony. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JPMorgan. All rights reserved.streetevents. NEW SPEAKER Terrance. Most of finis question for NEW SPEAKER Unless they are young. Clearly as I said the addition of the endeavor data to our label giving us both a doublet and triplet 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 patients in second line to plus a better opportunity. Jake. NEW SPEAKER Thanks for taking my | Contact Us ©2016 Thomson Reuters. The data in the market is quite shallow because we haven't looked at patient charts order. NEW SPEAKER Okay. I'm wondering how fast things could open up or 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. 2016 / 9:30PM. 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 foresee any right now. including by framing or similar means.Q1 2016 Amgen Inc Earnings Call 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. We don't anticipate the need for an advisory an FDA advisory committee for. is prohibited without the prior written consent of Thomson Reuters. AMGN . Once the data becomes clear it will become public and people have to make up their minds what that actually means. . NEW SPEAKER Corey because him off. With regard to Repatha access. Thanks for taking the question. NEW SPEAKER Okay so let me answer that question.PRELIMINARY APRIL 28. But as I look at the orders for the first quarter. 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 As Sean said we expect the data in the latter end of this year. this is Sean. I see turn 27 continue to hold market show and third line. It will be presented then in a peer reviewed publication and presented at one of the large congresses where the 11 THOMSON REUTERS STREETEVENTS | www. Assuming you get positive CVOT dated later this year what's your understanding of the process you need to follow in order to ease current utilization management. Republication or redistribution of Thomson Reuters content. 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 Good afternoon.

but anything more than that at this point. NEW SPEAKER Maybe a question for | Contact Us ©2016 Thomson Reuters. the pivotal is coming in and is a wealth of data coming. 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. NEW SPEAKER Well. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. there's a clear desire to update these guidelines as fast as possible when the cardiovascular outcomes data are available. . 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.Q1 2016 Amgen Inc Earnings Call data will become clear to all the prescribing cardiologists. All rights reserved. thanks. Republication or redistribution of Thomson Reuters content. is prohibited without the prior written consent of Thomson Reuters. mark. NEW SPEAKER Michael Yee. NEW SPEAKER This is Trinity. Thanks. NEW SPEAKER Jake. You talked in the cast about your hypothesis your mechanism in differentiation. 12 THOMSON REUTERS STREETEVENTS | www. including by framing or similar means. licensing as well as every day and we consider them each individual so I wouldn't speculate. NEW SPEAKER Great. RBC Capital Markets. In this environment biotech prices have obviously cut down. We of course. 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. Question for Trent eight. mark. 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. 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. Evercore ISI. In the interim however our medical affairs organization can respond to questions we received from the payers in a balanced and medical way. I don't know that I would make any comments about hostile acquisitions but as you've heard us say before. let's take the next question. But we look at all range of transactions. NEW SPEAKER Mark Schoenebaum.PRELIMINARY APRIL 28.streetevents. 2016 / 9:30PM. I'm wondering what your current feelings. 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. valuations in some areas of our track of this year than they were last year. But I'm assuming once this becomes clear the details will clarify the unique value of this particular product. Thank you very much. are around hostile acquisitions. Bob. AMGN .

So there's a lot going on. Piper Jaffray. All rights reserved. And of course the bite platform has a very large number of products 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.PRELIMINARY APRIL 28.streetevents. 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. NEW SPEAKER Sure. 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. 13 THOMSON REUTERS STREETEVENTS | www.Q1 2016 Amgen Inc Earnings Call NEW SPEAKER Thank you. 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. 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. 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 or earlier pipeline that your most enthusiastic to move into Phase 3 you mentioned him curious as to what else. Because of everything that happened it's happening at the commercialization phase we don't get a lot 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.000 to 10. Michael. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. 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. I'd like to talk about that sort of thing. 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. NEW SPEAKER Robyn Karnauskas. AMGN . Cardiovascular broadly we have some very interesting things we're working on in the early and mid-stage pipeline. And have quite a few early discovery level programs in that | Contact Us ©2016 Thomson Reuters. NEW SPEAKER Joshua Schimmer. 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. So what's the balance of lowering price and mortality outcomes as far as opening up access.000. Republication or redistribution of Thomson Reuters content. . Certainly Oma Campton is very exciting. including by framing or similar means. CIT I.000 who of that attempts or are currently on and off of therapy for prophylaxis. Thanks. 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 a larger amounts of protein were delivered for delivery on a monthly basis in a subcutaneous delivery device. 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. We've always felt that the receptor antagonist would be more potent and we're seeing that play out. is prohibited without the prior written consent of Thomson Reuters. 2016 / 9:30PM.000. How much are you willing to participate and deal with price versus say mortality outcomes.

NEW SPEAKER Thanks for taking my question. types of studies differ largely in the issue of how long it takes to enroll the population and what the event rate is once you get patients enrolled. There was and extrapolated value of these drugs would actually result in production of both stroke. Where there's quite a bit of detail in the way they were constructed. First one for Sean to talk about and outcome trial. 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.streetevents. 2016 / 9:30PM. Would you bundle the payment in dialysis what do you think could be that pricing power be for the product like this. And I think we will continue to bring this to market. . including by framing or similar means. There's more similarities than there are | Contact Us ©2016 Thomson Reuters. the of a Merrill Lynch. We don't believe we would not anticipate large differences in the event rates between the two populations. 14 THOMSON REUTERS STREETEVENTS | www. heart attack and early untimely death. is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. Clearly as we said we bring our products to market with a clear debate and discussion around the economic value of the products. NEW SPEAKER That's Tony. 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. particularly since to generate in a couple of years. NEW SPEAKER Eun Yang. Thanks. it's Tony. NEW SPEAKER Ching Wong. AMGN . NEW SPEAKER A question on. And in the end these studies. Jefferies. But there will be some different in event rate. CMS has granted a two-year period for this product will operate outside the bundle.Q1 2016 Amgen Inc Earnings Call NEW SPEAKER Robin. All rights reserved. I know you never disclose the assumption or the assumption for 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. As we jostle for position. 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. But I think what we bring to market at the moment is a pretty decent and acceptable value proposition to treat patients at high risk. In the marketplace and that can dynamic will continue over time. Obviously you may be looking for more but that would be the way you power the trial. 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. As you know. Let me answer this one. Republication or redistribution of Thomson Reuters content.PRELIMINARY APRIL 28.

. NEW SPEAKER I'm noticing it is faster closing 6. 15 THOMSON REUTERS STREETEVENTS | www. All rights reserved. the market is broken into three. Lincoln relink partners. I am in for Jim. 30 p. But there's a large bowl is a patient who failed consistently on existing treatment in the marketplace.PRELIMINARY APRIL 28. And that setting we have converted about 70% of the usage to Aranesp Geoffrey Porges. The last time they made any numbers public they were talking about just over 70% conversion to Masera. Persinius who is another one third of the market on the process of converting all of their patients. However. Enbrel itself is competing in a highly competitive marketplace with several large players are competing for position to enable patient access. Republication or redistribution of Thomson Reuters content. Unlike most other diseases. 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. We have contract with them that is exclusive and runs through 2018. 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 Amgen's all about innovation so as we price our drugs around the pharmacoeconomic values of the products as we bring them to market. NEW SPEAKER Thank you. 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? | Contact Us ©2016 Thomson Reuters.streetevents. 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. Just to reconfirm again.m. Davita is responsible for about one third of the market. At the same time the health plans and the PBMs are negotiating price concessions on large rebates to set up places that sell and it's because of the magnitude of these rebates that the pricing increases have become part of this overall dynamic. Could you talk a little bit about price in Enbrel. You have the clear lead. is prohibited without the prior written consent of Thomson Reuters. I appreciate the question. 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. medium and small dialysis units. 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. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. a couple for you. So it's an integrated process flow as we go forward. NEW SPEAKER Thanks for squeezing us in. AMGN . It's debilitating. The other one of the market is the independent. The first Phase 3 data readout for that frequent episodic migraine indication. How do you think you're going to approach the value proposition that indication to avoid the really tight restrictions you've encountered. It is devastating. in a chronic migraine indication it's a little less clear because others have Phase 3 programs ongoing. Let's take two last questions. NEW SPEAKER Jim Burchinal. Wells Fargo Securities. The contribution of price. Talking about 334. I think as a company we are acutely aware of the issues facing the industry in the US at the moment. patients with chronic migraine really know about a. Tony. And some of the initial research we've done have shown a much higher inclination or preparedness to pay a co-pay because patients really want to get rid of the disease as quick as they can. 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. 2016 / 9:30PM. Question is. including by framing or similar means.Q1 2016 Amgen Inc Earnings Call NEW SPEAKER Some of the answer your question on the dialysis market. You're right. on the East Coast. 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. NEW SPEAKER Let's go back to depricing.

Can you just discuss more about Repatha in the EU and Japan in terms of your experience of access and reimbursement and if you think that the CVOT outcomes data will change the negotiation or would that be a new round of negotiations. Of course I'll be around together with the rest of my team so if we can offer any further assistance please give me a call. I believe that as we get into growing into this marketplace. the therapies the analogy is probably quite shared across these as evidenced by the fact that all the CGRP antagonists are having similar advocacy in the different patient populations. Cowen and Company. is prohibited without the prior written consent of Thomson Reuters. I think that the things you have to take into account is that the chronic migraine Phase 2 B study is quite a large study. NEW SPEAKER I think you've heard people talk about the performance and Europe where once the price has been set and reimbursement is agreed there is no longer an economic decision around their prescription update happens quite fast. busy day. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. Have a good day. AMGN .com | Contact Us ©2016 Thomson Reuters. NEW SPEAKER Great. . Thank you. For Tony. You may now disconnect. And I would not typically go into the discussions about the specific conversations we've had with regulators but I just say that we feel that it's a very reasonable approach to attempt to get both indications based on the aggregate data package. 2016 / 9:30PM.Q1 2016 Amgen Inc Earnings Call NEW SPEAKER This is Sean.PRELIMINARY APRIL 28. NEW SPEAKER Great. NEW SPEAKER Ladies and gentlemen this concludes Amgen's first quarter financial results conference call. These are obviously -. pricing is just about set.there is a spectrum of disease here and while there is a separate regulatory entity of chronic migraine and episodic migraine. When you come in with larger expanded patient population groups there's a chance in Europe you have to go back into a country by country negotiation. Thanks. everybody for your participation on this busy. NEW SPEAKER [ End of transcript ] 16 THOMSON REUTERS STREETEVENTS | www. All rights reserved. Let's take one last question first two Jeff Chen. NEW SPEAKER Thanks for taking my question.streetevents. And it explores doses that are used in two large Phase 3 episodic migraine studies. Republication or redistribution of Thomson Reuters content. including by framing or similar means. So it's our feeling that taken together the data could potentially support both indications being granted at least by some of the global regulators. In Japan historically that hasn't happened as much and a depricing we received in Japan seems to be a longer play through from pricing.

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