AMGN
#Thank you, <UNK>, and good afternoon folks
You'll find the details of revenue starting on slide number 10 of your deck
Strong and continued volume growth by Prolia and our more recently launched brands like Repatha, KYPROLIS and BLINCYTO helped offset declines in our mature brands
Excluding the impact of foreign exchange, sales growth was flat year-over-year as reported sales declined 1%
declined 2% year-over-year, and sales outside the U.S
grew 5%, excluding the impact of foreign exchange, driven by a robust 8% volume growth
Let me start with Prolia
Prolia continues to deliver exceptional performance after being on the market for over seven years
Prolia grew 22% year-over-year with double digit volume growth in all markets, primarily from share gains
Quarter-on-quarter, we saw a slight decline, which follows the typical pattern for Prolia in the first and the third quarters
Prolia, as Bob said, is a unique asset with a very strong value proposition
There remains a large underserved osteoporotic population at risk for fracture
These fractures often cause loss of independence for patients and place a large burden on caregivers and society
We remain focused on improving diagnosis and treatment rates in order to bring Prolia to more of these patients in need
With share around 20% in most markets, there continues to be a lot of room for Prolia to grow and we are investing accordingly
As I mentioned before, there are some countries such as Australia, Switzerland and Ireland with better diagnosis and treatment rates for osteoporosis where Prolia has a 50% share or better
These are countries that truly understand the societal costs of nonintervention
KYPROLIS grew 13% year-over-year in a competitive multiple myeloma segment with several new entrants
Outside the U.S
, we continue to see strong growth from both existing and new markets
KYPROLIS is a unique product in a competitive position having two compelling sets of overall survival data in relapsed multiple myeloma patients
Our most recent market share data in the U.S
shows an improvement in new patient share in second line setting
This is an important leading indicator for sales growth into future quarters
KYPROLIS also continues to have a prominent position in the NCCN Guidelines for all lines of therapy
XGEVA declined 2% year-over-year, primarily due to a shift in timing of purchases from some larger end customers
We believe XGEVA's positioned for growth in 2018 with the addition of a multiple myeloma indication
Neulasta declined 6% year-over-year due to a shift in timing of purchases by some larger end customers as well as a small decline in the number of myelosuppressive chemotherapy regimens
The Onpro kit grew share to 56% of Neulasta units and we expect to continue to drive additional Onpro adoption into 2018. Our most recent in-market data shows that Onpro drives better adherence to therapy, which leads to lowering of rates of febrile neutropenia, and in fact lower rates of hospitalization
Simply put, Onpro is a better value to the healthcare system and this is an important point of potential differentiation for the future
With NEUPOGEN, the impact of short-acting biosimilar competition was consistent with prior trends
We exited the quarter with 41% share of the short-acting segment and we have continued to maintain pricing discipline despite the competitive pressures NEUPOGEN has faced over the last several years
Enbrel sales declined 6% year-over-year, in line with prescription trends
We expect these prescription trends to continue into 2018. Segment growth year-over-year was in line with last quarter across both rheumatology and dermatology segments, confirming the rebound from the slower growth seen in quarter one
Enbrel lost less than 1 point of share in both segments in this quarter, consistent with prior trends
Quarter three saw a low single digit year-over-year decline in net selling price
Overall, we expect there to be a very slight year-over-year decline in net selling price for the full year 2017. Most formulary decisions for 2018 have now been finalized and we expect the net selling price trends of 2017 to continue into 2018. You may recall that we noticed some potential excess end-user inventory at the end of quarter two
End-user inventory levels are estimated by deducting the value of prescriptions from the value of wholesaler shipments to end customers
Based on this data, we did not see a depletion in the third quarter
And if prior fourth quarter patterns hold, we would not expect a depletion in the fourth quarter either
We continue to make investments to maximize Enbrel's long-term value such as the imminent launch of our Enbrel AutoTouch, a reusable auto injector that is ergonomically designed to meet the needs of rheumatoid arthritis patients
Lastly, we look forward to extending our information franchise into Europe next year with the launch of AMGEVITA, our biosimilar to HUMIRA
Aranesp saw modest declines of 3% year-over-year
We had a small unfavorable impact from foreign exchange and unit volume declined slightly globally
EPOGEN declined 21% year-over-year
The primary driver was lower net selling prices, in line with quarter one and quarter two as a result of our extended DaVita agreement
In the third quarter, we did not see any underlying changes in the EPOGEN business, did have some unfavorable inventory changes which added to the year-over-year decline
Sensipar increased 10% year-over-year, primarily due to net selling price
We've now launched Parsabiv in over 10 countries in Europe and our partner ONO has had a very successful launch in Japan
We're preparing to launch in the U.S
when CMS reimbursement code for Parsabiv becomes effective on January 1, 2018. Now to Repatha
Our cardiovascular team continued its strong competitive execution, reaching 60% of total prescription share in the U.S
and 57% in the EU. In the U.S
, new to brand share, which in my mind is a forecast of future sales, in the U.S
reached 74%
Sequentially, our Rxs grew by 20% in the U.S
, however, sequential sales growth was tempered by changes in inventory and accounting adjustments that benefited the second quarter
We continue to work hard with payers to improve access for appropriate patients
And we look forward to the FDA's priority review of Repatha's cardiovascular outcomes data, which will allow us to start promoting Repatha's ability to reduce heart attacks and strokes with both physicians and patients in December this year
Cardiovascular disease continues to be the number one cause of death and disability in the world and it's a top priority of Amgen to ensure that appropriate patients have access to Repatha
So in conclusion, we are focused on a strong finish to 2017. As we prepare for numerous launches in 2018, which include our Repatha outcomes label, the Enbrel AutoTouch device, Aimovig for migraine, Parsabiv, the XGEVA multiple myeloma indication, as well as large opportunities from our biosimilar franchise
Let me for a moment stop and say thank you to all the Amgen staff, who have worked so hard and tirelessly this quarter to get our important drugs to patients around the world
And now let me pass you to <UNK>
So, Chris, this is Tony
Clearly, I'm not happy with 56%
If I look at the product value that this thing brings in terms of enhancing patients' ability to go home, the value to a large institution in terms of how they treat patients, we will continue to drive hard to increase that share beyond 56%
Okay, Matt, so Tony, let me respond there
So, the market share we've achieved to date has been in the presence of a competitor
So as I think about going forward, we will continue to be competitive
And I think getting more and more patients on Repatha is our objective, which we've been quite successful with
We are working extensively with payers at the moment in terms of improving potentially the utilization management criteria and working on trying to reduce the onerous bureaucracy that takes place and frustrates physicians at the moment
We look forward to being able to pull some of these things through potentially in 2018.
So, <UNK>, clearly we think that the market in the beginning will be a branded biosimilar market
And therefore, the value we bring as an organization about the quality and the continuity of our supply is really important
The relationships we have with large institution, with small community clinics is really going to be important as well
So we will focus very clearly upon our relationships of the past, our skills of the past, as well as the value of the product we bring to market
Okay
<UNK>, so as I've said, the end-user inventory is a triangulation we do in an attempt to give you guys as much visibility as possible about what we know to allow you to run your models
But fundamentally, we do the calculation based on what the Rxs are in the marketplace, which I'm never 100%, minus what we know our wholesaler have sold to the end users and the balance we assume is an inventory build
When I look back five years, I've never seen an inventory burn in the fourth quarter, so we're making the assumption that there wouldn't be an inventory burn this fourth quarter as well
As regards to 2018, as I said in my earlier comments, most of our contracts have been negotiated, although that doesn't mean that there won't be negotiations that continue going forward during 2018, but we do expect the net selling price for Enbrel, the trend you've seen in 2017, we expect that to continue to 2018.
So we are bringing Parsabiv to market based on the clinical data we have at present, right
So by definition, secondary HPT is a very difficult thing to treat and adherence is a real problem
I think we have about 150,000 patients on the drug at the moment which is only about a 26% penetration
The head-to-head data we have shown great levels of efficacy of Parsabiv and without doubt in our mind, we will see a better level of adherence as physicians are back in control
All feedback we have had to date from nephrologists in the marketplace has been very good
They are looking forward to having this drug available
So whether it's a switch or replacement or usage during a treatment period will be dependent upon the physician or the dialysis unit in terms of their guidelines
So this is Tony
Thanks, <UNK>
I just came back from the International Headache Conference (sic) [International Headache Congress], which was in Vancouver, where I was meeting with a group of key opinion leaders and individuals who run headache clinics together with me with my counterpart from Novartis, Paul Hudson
So he and I, we're working this together
So as we think strategically, the two organizations are doing a lot of strategic thinking together
We both jointly agree that we probably saw more enthusiasm from this set of neuro physicians than we've ever seen in many other physicians in other congresses
People are talking about this is the first time they are being able to potentially prescribe a migraine drug for migraine patients in two decades
So I came away feeling much more positive about the scientific understanding, the clinical need and the large population that is waiting for this
The work we've done at the moment with migraine bloggers and patients who are suffering from migraine has also been very beneficial
We understand much better now the patient's journey, the importance of the work we have to do with patients and their willingness to work with us to spread this good message once we have our drug approved
Obviously, we continue to work with payers in strategic discussions, but we haven't made any final decisions around pricing as we go forward
Sure, <UNK>
So I think first of all, the magnitude of the market is different, right? In the U.S
, we estimate about 3.5 million patients right now are being treated for prophylactic treatment of migraine
A lot of those patients fail
A lot of those patients go off treatment because of side effects
A lot of those patients find the treatment is not effective
I think we believe that we will clearly be positioned for patients who failed existing therapy
And last but not least, I think patients are much more aware of the disease
This is a symptomatic disease
When you have a migraine, you're very much aware of it
So I think patient mobilization in terms of their voice around the need to have access to drug is going to be important
The value these drugs bring to the marketplace too, when you think about how debilitating migraine really is in terms of stopping people from going to work, preventing people from being mothers or caregivers, there is huge value to society to allow these people to get back their independence and to become normal citizens again
So we clearly believe that having a single J-code is not what you want, right? If you believe that a biosimilar has to be a decision made by a physician, you want clarity around each single product has to be able to reflect in the marketplace
So we're working hard to ensure that we have actual J-code by product as we go forward
On the pricing one, I'm not quite sure what the competition is doing and that's their decision
Yeah, I don't think any of the inventory movement had anything to do with the hurricane
Most of the discrepancies were as a result of contracts ending early and buying in that took place in the second quarter which would normally happen in the third quarter
There was sufficient inventory both in our supply chain here as well as in the wholesaler supply chain during this period
I think if you were at the ESC recently when we presented some of the subcuts of the Repatha outcomes data and we looked at the cohort where you had patients who entered at LDLs below 70 and how as you drove LDL down to levels way below 70, you actually got a higher reduction in myocardial infarction and reduction in stroke, and our data alone showing up to about a 33% reduction in MI
I can't understand why you wouldn't want to do anything other than drive LDL down as low as you can
So our drug does that, other drugs don't
