AMGN
#Thanks.
Thanks for your question, <UNK>.
We are focused on having this matter reviewed on the merits, and as you point out, we are fortunate that it looks like we are going to be able to do that early in the new year.
So we will look forward to again this being reviewed in its entirety.
And as you know and as we have said before, we feel we have a very strong intellectual property patent estate on this product.
And we demonstrated in the past our determination to assert our IP rights and defend them, and that's what we look forward to doing for this product early next year.
Yes, so first of all in Q1 as we said, we are really encouraged by the performance in the business, which was obviously a combination of solid topline growth, as well as the fact that we had very good expense management in the quarter.
If you frame that as to how that evolves through the year then, what I would say is a couple things.
One is we had indicated previously that we expect this year our transformation to deliver about $400 million of incremental savings.
And certainly we saw a share of ---+ a proportionate share of that already land here in Q1, and those savings will continue pretty steadily through the year.
The second dynamic on cost then is around the cost trends.
In particular if I look at SG&A and the sales and marketing area as well as R&D, we do expect to see rising costs, which is a combination of the fact that we inevitably ---+ normally for the business, the first quarter is the low point for expenses overall for the year.
But I think importantly for us right now, we do have these launches that are coming up, we do expect to underwrite those launches significantly with this transformation savings, and we do expect the trend of spending to increase through the year.
So I think you have basically framed it correctly as now we are thinking about this evolving in the year.
<UNK>, not to miss the opportunity to talk about the long-term, as I said and as <UNK> said in his remarks, we feel we are clearly making progress towards our long-term objectives, including that margin objective.
Brian, let's take the next question.
<UNK>, based on our understanding of the legislation, based on the progress we're making in developing adalimumab, we still expect we will be in position in to launch that in 2017.
And of course with respect to the Sandoz matter, we are expecting that that will be heard in the appeal courts later in the year.
<UNK>, do you want to add anything.
It was a little bit hard to hear your question, but I think you were asking about Corlanor and Repatha.
We are excited as we have said to get launched in the cardiovascular field with Corlanor, and we think again an innovative medicine that will require some work to educate the cardiologists about the appropriate use of this medicine with heart failure patients, but we are excited about that.
And we are excited also about the innovative biology behind Repatha and the opportunity for that medicine to make a big difference for patients who are at risk of heart attack and stroke.
So our focus is on those two medicines right now.
To the extent that we have other opportunities to advance innovative biology with big effects in cardiovascular disease, we will look carefully at those.
And as you know, we have one such medicine that is in late stage of development, now which is our omecamtiv mecarbil program which <UNK> referred to in our earlier remarks.
And those constitute three pretty exciting innovative opportunities for us right now, and if we find opportunities to build on those, we will look at them carefully.
Why don't we break that into two parts.
<UNK> will talk about the Humira question first.
<UNK>.
Yes.
In terms of the cost savings, what I would first say is that if you look at the savings we expect this year as well as through the whole program, as we have said before, those are savings that are being accrued across all of the areas of cost.
So it's not concentrated in one versus the other.
Secondly, if you look at the particular pattern of savings in the first quarter, what you can observe as I mentioned is that ---+ and as we have talked before, we are investing freeing up flexibility to invest in our launch portfolio.
So you can expect that a substantial share of what we save in SG&A will be reinvested toward the launches.
And then I think the third thing I would comment as to R&D, that was a combination in the quarter of R&D tends to be rather lumpy in terms of the spend.
So you saw a combination of savings that we are getting from our transformation in the quarter, as well as some of the inevitable lumpiness that occurs from quarter to quarter in that area.
I think bottom line is that we expect going forward through the year to see rising costs, which you typically see in the pattern through the year, but see it a little more accentuated as a combination of rising cost with launch activities, as well as in the case of R&D, we still are continuing to invest in clinical trials.
And we will see some increases there.
And then as to ---+ if I may, one final comment ---+ R versus D, as we have talked before, we have done work to look at all the processes across all of our business activities, and so we are seeing efficiencies in both of those areas broadly.
Brian, why don't we take one last question as we are getting to the top of the hour.
<UNK>, thanks for your question.
As you point out, things are going very well for Kyprolis, and we are excited about the data that we have in hand, as well as the data we may generate.
Thanks for joining our call.
<UNK> and his team will be around if there are questions you didn't have a chance to ask on the call, and we look forward to connecting with you on the next quarterly call.
Thanks.
Thank you, everybody.
