Earnings Labs

Amgen Inc. (AMGN)

Q1 2019 Earnings Call· Tue, Apr 30, 2019

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Transcript

Operator

Operator

My name is Ian and I will be your conference facilitator today for Amgen's First Quarter 2019 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speaker’s prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Arvind Sood

Analyst · Ronny Gal from Bernstein

Okay, thanks Ian. Good afternoon, everybody. Thanks for joining us today on our first quarter call. Special welcome to those who are new in their coverage of our company including Jay Olsen of Oppenheimer, Yaron Werber of Cowen, and Bill Kim of BMO. So we go into 2019 having put in place a strong track record of execution, and we are well prepared for the challenges and opportunities ahead. I'm joined today by our Chairman and CEO Bob Bradway, who will provide a strategic overview of our business and the environment we operate in. after Bob’s comments, our CFO David Meline will review our financial results for the first quarter. Our Head of Global Commercial Operations, Murdo Gordon, will then review our product performance, following by our Head of R&D David Reese who will provide a pipeline update. We will use slides to guide our discussion today and you should have received a link separately. Just a reminder that we will use non-GAAP financial measures in today's presentation and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that could cause our actual results to differ materially. So, with that, I would like to turn the call over to Bob.

Bob Bradway

Analyst · Matthew Harrison from Morgan Stanley

Thank you, Arvind, and let me add to Arvind’s welcome to all of you joining the call today. We entered 2019 with a strong track record of execution and an improved ability to innovate, compete, and grow over the long term. We feel now well positioned to capitalize on the growth opportunities presented by our newer products in our pipeline, even as we effectively defend our mature products against emerging and expected new competition. As you know, drug prices are being challenged around the world, and we, therefore, have said for some time that we expect volume-driven growth to be important to our long-term success. And in Q1, we once again demonstrated our ability to grow unit volumes, especially for our newer products like Prolia, Repatha, and Aimovig, as well as for our six hematology/oncology products that are in early phases of their life cycle. I believe our performance outside of the US, where we have faced biosimilar competition for over a decade is instructive. There, our business generated 15% unit volume growth in the first quarter as growth of our newer products more than offset the erosion of our mature brands and biosimilar competition. We remain confident in the lifecycle management strategies we have in place to defend our mature brands, and we believe there is considerable upside potential with our newer products that will drive attractive long-term growth. As a leader in bone health with Prolia, we know that there's a need for an additional innovative therapy for women who are at high risk for fracture from postmenopausal osteoporosis. In Q1, we added Evenity to our portfolio of first in class innovative medicines with approvals in Japan and earlier this month in the US. Postmenopausal osteoporosis remains a highly underdiagnosed and undertreated disease with potentially devastating consequences from…

David Meline

Analyst · Geoffrey Porges from Leerink Partners

Okay, thanks Bob. The first quarter marked another period of solid performance for the company as we delivered mid-single digit volume growth globally, while we increased investment in the business and delivered year-over-year non-GAAP EPS growth in the first quarter. Turning to the financial results on page six of the slide deck, worldwide revenues were 5.6 billion in the first quarter, with worldwide product sales of 5.3 billion, declining 1% year over year as strong unit demand for our newer products was offset by declines in our mature products, including small molecule generic competition against Sensipar. Other revenues at 271 million, increased 60 million driven by royalty income growth. As we continue to make incremental investments to rapidly advance our innovative pipeline and maximize the value of our marketed products, our non-GAAP operating expenses increased 11% year over year. This also contributed to our non-GAAP operating income result at 9% lower than previous year. On a non-GAAP basis, cost of sales as a percent of product sales increased by 2 points to 14.7%, driven by higher manufacturing costs and product mix, partially offset by lower royalty expense. As mentioned last quarter, for the full year, we continue to expect year over year cost of sales expense to be flat to up depending on sales volume. First quarter research and development expenses of 859 million were 16% higher due to increased investments in support of our multiple differentiated early-stage oncology programs. Research and development expense as a percent of product sales was 16.3% for the quarter. For the full year, we currently expect R&D spend on an absolute basis to rise in single-digit percentage terms in 2019. SG&A expenses increased 5% on a year-over-year basis, primarily driven by support for our newly launched products, including Aimovig, Evenity, and our biosimilar Amgevita…

Murdo Gordon

Analyst · Ying Huang from Bank of America-Merrill Lynch

Thanks, David and good afternoon everyone. You'll find product sales information starting on slides 10 and 11. We're off to a solid start in 2019 with continued volume driven growth across our portfolio of newer products, while we successfully execute lifecycle management strategies in our more mature brands. Moving to first quarter results, let me start with repatha on slide 12. Given the dynamic nature of the PCSK9 class and our confidence in Repatha, I want to provide some detail on its performance and growth prospects. Q1 sales grew by 15% year-over-year, as we hold leading share of the PCSK9 class. Worldwide unit growth was 81% year-over-year with 90% unit growth in the US. The growth is attributable to increasing prescribing depth by cardiologists, increasing prescribing breadth by primary care physicians, and increasing patient fulfillment following the introduction of lower list price Repatha. In Medicare, lower list price Repatha is now available to more than 60% of seniors. The next step is to make the lower list price version available to a majority of Part D patients at a lower fixed copay versus the current co-insurance structure. While this is underway, it's expected to improve early next year as Part D plans update for 2020. Currently, only 6% of Medicare patients are at a low fixed copay level of above $50. For patients covered by commercial insurance, approval rates have improved by 11 points year-over-year, as we continue to secure improved payer utilization management criteria through contracting. We will continue to work with health plans, PBMs and the US administration to get lower list price Repatha to patients more rapidly. And we remain committed to discontinue our original list price Repatha we see sufficient coverage in the market, which could be between now and the beginning of 2020. With regard…

David Reese

Analyst · Yaron Werber from Cowen and Company

Thanks, Murdo and good afternoon, everyone. We're off to a rapid and exciting start to 2019 in R&D with progress across our pipeline. I'll begin with our oncology portfolio. We continue to advance our BiTE platform with approximately a dozen molecules now in or close to the clinic. In hematologic malignancies, at ASCO, we will provide an update on the dose escalation trial of our first generation BCMA BiTE molecule, AMG 420. We are now enrolling patients in a dose expansion study. We also expect some of the first clinical data from our new generation BiTE platform by the end of the year with AMG701 and extended half life BCMA BiTE molecule. Our enthusiasm is high for our BCMA BiTE molecules as well as our CD38 bispecific and MCL1 programs as we pursue our commitment to develop therapies that can make a meaningful impact on the treatment of multiple myeloma. Other presentations at ASCO will include the first in human dose escalation study of AMG 212, a BiTE molecule directed against prostate specific membrane antigen, or PSMA, which is highly and specifically expressed in the majority of human prostate tumors. This clinical study was conducted by Bayer through a license they had with Micromet prior to our acquisition. We believe the data from this trial provide proof of concept for the target and bispecific T-cell engager approach in solid tumors, and we have introduced a new half-life extended BiTE molecule, AMG 160, into clinical testing for prostate cancer. AMG 160 is now progressing briskly through dose escalation. As with all of the targets for which we have both first generation and half-life extended BiTE molecules in clinical development, we will preferentially advance the halfway extended molecule if we observe comparable safety and efficacy between the two formats. One final note…

Bob Bradway

Analyst · Matthew Harrison from Morgan Stanley

Okay, thank you. Let's open the line up now for questions. And perhaps, I can ask our operator to remind you what the procedures are for submitting your questions. Thanks.

Operator

Operator

[Operator Instructions] Our first question is from the line of Matthew Harrison from Morgan Stanley.

Matthew Harrison

Analyst · Matthew Harrison from Morgan Stanley

Dave, I was hoping to ask a two part on KRAS. So I guess the first thing is, it seems like you've progressed through the dose escalation period fairly rapidly. Is that because you hit the MTD faster than you were expecting or are there other factors such as faster enrollment at play? And then how should we view the fact that you're pushing forward here with combinations with PD1? As part of that, the monotherapy efficacy that you've seen is below what you were expecting, or do you think you can drive efficacy substantially higher with those combinations? Thanks.

Bob Bradway

Analyst · Matthew Harrison from Morgan Stanley

Thanks, Matt, for the questions around the KRAS program. Let me take them in order. In terms of the dose escalation, I think we will present the clinical data at ASCO. We had a planned dose escalation in the phase 1 trial, we were able to move through that very quickly based on tolerability. We had quite brisk enrollment based on pre-identification of patients at most of our centers, and we're pleased to have been able to move along in eight months, in a population that is a fraction of lung cancers and other tumors. In terms of the combination, as I've indicated before, I think based on the clinical setting, these molecules may find a home as either monotherapy or in combination. It’s early days, and we're moving quickly to investigate both of these approaches as we move forward and the combinations will be not only with PD-L1 inhibitors based on some of the preclinical data that I described in terms of the KRAS inhibitor, inflaming tumors, and upregulating MHC 1 expression, but also data we've generated on other components of the pathway. So I think all of those will be pieces of what we explore going forward. This program is moving as quickly as almost any I've ever seen here at Amgen.

Operator

Operator

And our next question is from the line of Terence Flynn from Goldman Sachs.

Terence Flynn

Analyst · Terence Flynn from Goldman Sachs

Maybe Bob would love your perspective just on the proposed Part B demonstration project. In particular, do you anticipate that the IPI proposal could remain here, do you expect there could be any changes? Thanks a lot.

Bob Bradway

Analyst · Terence Flynn from Goldman Sachs

Well, it's a proposed rule as your question implies, Terence and that enabled quite a bit of commentary and the administration has received something like 4,000 comments from different groups, including quite a wide range of physician groups and patient groups that were concerned about the proposal. It won't surprise you to know that we're concerned about it, and we've expressed that concern as well. We're not interested in seeing patient access to innovative new medicines and physician choice impaired by a potential rule like this. So we and others in the innovative industry have expressed that to the administration. And I think if you compare the situation in the United States where patients have access to innovative medicines very rapidly, in fact, if you just look at cancer, 95% of the new cancer medicines are available to Medicare patients here in the US, and that compares to about 65% of the same medicines being available in France. And by the way, in France, they're available some 21 months later. So in a cancer patient, that can mean the difference between life and death. So we're not in favor of a rule like this that might have the effect of diminishing access to innovation and impairing investments in innovation over the long term. Having said that, we have been working with the administration around other proposals that we think can help address the concerns of the administration, and we'd like to continue to do that. So we think there are some things that the administration could pursue that would enable the government to get access to the market prices and still enable physicians and patients to use the medicines that they think are appropriate for these diseases.

Operator

Operator

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

Ying Huang

Analyst · Ying Huang from Bank of America-Merrill Lynch

My first question has to do with the Neulasta trend. So year-over-year, sales came down by 12%, units went up by 1%, inventory went down 3, so by my math, the net price is probably coming down by roughly 10%. Can you comment on the pricing trend for the rest of the year for Neulasta? And then can you quickly provide an update on the Enbrel patent ruling against Sandoz.

Murdo Gordon

Analyst · Ying Huang from Bank of America-Merrill Lynch

So Ying, I'll take the first one and then I'll ask Bob perhaps to talk about the other question regarding Sandoz and Enbrel. I think overall, we're pleased with how we're performing in the market despite two biosimilar competitors against Neulasta. In particular, we see good durability of our Onpro business, which is holding at around 60% share of the long acting filgrastim franchise. We also continue to compete at an account by account level, and we defend as you point out significant volumes. What will drive further price erosion and potentially share erosion is the number of new competitive entrants, and we're following that very closely going forward.

Bob Bradway

Analyst · Ying Huang from Bank of America-Merrill Lynch

On the court case, nothing new to report. As you know, we're waiting for the judge to rule and nothing new to report there.

Operator

Operator

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

Geoffrey Porges

Analyst · Geoffrey Porges from Leerink Partners

Thank you very much. And first question, David, just on the KRAS, could you help us understand how -- in terms of expectations, how treatment response to this particular intervention should compare to other mutations in lung cancer that we're accustomed to seeing? For example, for EGFR, just is it likely to be as canonical if you like as those mutations? And then secondly, Murdo, if you could just give us a little bit more color on Aimovig in particular, it does look as though you've come out of some pressure in terms of share of new prescriptions. Is that a one-time event in the first quarter that we're seeing in the prescription data or has there been a step down because of the contract, and is this the new baseline? Thanks.

David Meline

Analyst · Geoffrey Porges from Leerink Partners

Sure, I'll go ahead and start with the question regarding KRAS biology. I think, there's probably no specific answer for that, Jeff. In some tumors, this mutation will be a trunk mutation, a driver mutation, and we may well expect monotherapy activity in other tumors based on the other suite of molecular alterations that are present, you may need combinations or another approach. I think these are all things we will sort out where we'll be doing extensive molecular profiling on the tumors as we move forward to try to sort out the best predictors of response and resistance.

Murdo Gordon

Analyst · Geoffrey Porges from Leerink Partners

Yeah, and Jeff, considering the huge unmet need in migraine, we continue to feel good about the opportunity to grow new prescription base and to continue to compete effectively for share. As you know, we're still the market leader with 60% TRx share, around a 40% NBRx share. We have nice coverage across commercial and Medicare Part D payers. And we continue to drive good increases in the percent of patients that are paying for their Aimovig through commercial insurance benefits. So what we are seeing in our trends, in our total prescriptions is some effect of the bolus of patients that we secured when we first launched into the market and working then through the free drug to paid transition. We're also trying to understand what the persistence is in the CGRP category. We saw that it was between 20% and 30% in clinical trials, we'll be looking to see how that shapes up in the real world as we move forward.

Operator

Operator

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

Kennen Mackay

Analyst · Kennen Mackay from RBC Capital Markets

Quick R&D question, you'd mentioned tezepelumab phase 2 moving forward in atopic derm, hadn't Tezepelumab missed a primary important in the prior phase 2a and AD and what sort of the difference in how you're thinking about this, how high has this evolved?

Murdo Gordon

Analyst · Kennen Mackay from RBC Capital Markets

Yeah. I think we've gained a greater understanding of the approach to the disease, the variants and background medications. This is the disease that also has a waxing and waning on natural history. And so, we have, with our partners, have designed a subsequent phase 2 study that we think will rigorously evaluate the utility of Tezepelumab in AD.

Operator

Operator

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

Carter Gould

Analyst · Carter Gould from UBS Equities

I want to change the pace for a second, ask one on the Omecamtiv progress you've been making, specifically, if there are any additional planned interim analyses either for futility or stopping really for efficacy. And then just maybe your initial thoughts on how this, you think this may be positioned in HF, maybe alongside [indiscernible]?

David Meline

Analyst · Carter Gould from UBS Equities

Sure. This is Dave. I'll take that question. So, typically in these trials, there are interim analyses for efficacy. They are event driven, and we will communicate at the appropriate time as we might expect those data. I think one of the things that excites us about Omecamtiv is that its mechanism of action is novel, we think it's orthogonal to many of the existing therapies and should be able to be added to existing background therapies. To me, that's one of the potential great attractions of the drug for advanced heart failure.

Operator

Operator

And our next question is from the line of Yaron Werber from Cowen and Company.

Yaron Werber

Analyst · Yaron Werber from Cowen and Company

Great. Thank you. So David, I've also a follow up on KRAS, can you give us a little bit of a sense, was this a typical three by three dose escalation? Or are you doing into patient escalation? And would you break out the results by tumor type as well? And then I have a quick question on Sensipar.

David Reese

Analyst · Yaron Werber from Cowen and Company

Yeah, what I'll say is all those questions will be answered at ASCO. And, I don't want to get out in front of our investigators and steal their thunder, but will provide great detail in the phase 1 presentation. What was your second question? Wanted to ask a second question about Sensipar?

Yaron Werber

Analyst · Yaron Werber from Cowen and Company

Can you give us a sense? Are the launchers for Sensipar, are they [indiscernible] and are they still subject to the litigation coming up in in June?

David Meline

Analyst · Yaron Werber from Cowen and Company

Yeah, so what I'd say, this is Meline. So first point is, if you look at the guidance that we offered this afternoon, what we've given you is, while it's a bit narrower, it's still quite broad. And the reason for that is the uncertainty around, will we have additional launches this year or not. And of course, that is driven by the fact that we do have litigation that's still going on and we expect that to conclude here sometime in the coming months. So, hence the breath of the guidance.

Operator

Operator

And our next question is from the line of Do Kim from BMO Capital Markets.

Do Kim

Analyst · Do Kim from BMO Capital Markets

I wanted to ask about the Humira biosimilar market in Europe. We know that biosimilars in the European landscape is fairly mature. But with so many competitors out there, how are you seeing how the market for Humira will shape out and how do you position your biosimilar with so many competitors?

Murdo Gordon

Analyst · Do Kim from BMO Capital Markets

Yeah. Thank you, Do for the question. This is Murdo. What we're seeing in Europe in general in the biosimilars market is more rapid penetration of the biosimilars of the innovator compound, so higher biosimilar penetration in general across a number of different categories. Our shares are more or less in line with what we had anticipated and price is a little lower. So we're seeing higher volume due to that penetration, offsetting somewhat lower prices and the prices you have to be a little bit careful. Most of the interest and news that we read about on pricing, particularly in the case of the Humira biosimilar were related to tender prices in some smaller European markets. And those were pretty significant winner takes all price reductions. What you're seeing in the broader marketplace at the national formulary level and at regional formularies are better prices holding up quite well and we foresee the biosimilar business to be a significant revenue driver for some time to come.

Operator

Operator

And our next question is from the line of Jay Olson from Oppenheimer.

Jay Olson

Analyst · Jay Olson from Oppenheimer

I'm curious about the VESALIUS-CV outcomes trial for Repatha. Can you comment on the key differences between this outcomes trial and the Fourier trial and how that study may impact on long term commercial potential for Repatha? And then separately, anything we should be looking out for at AAN next week in terms of data for Aimovig. Thank you.

David Reese

Analyst · Jay Olson from Oppenheimer

Well, I'll get half of the Repatha question and then Murdo will take the other one and I can address that Aimovig at AAN. So in terms of VESALIUS, these are patients with known, essentially known coronary artery disease, but who have not had an event, so they are very high risk. It's a population that, numbers in the millions beyond what we were the target population studied in the Fourier trial. We think it should add to the substantial body of evidence that we have with Repatha in another high risk population. Murdo, you may want to comment on the commercial component.

Murdo Gordon

Analyst · Jay Olson from Oppenheimer

Yeah, we’re continuing to work hard to penetrate that high risk cardiovascular patient population and compete in that category. We are seeing the data are more similar than different to what we've already had in the public domain. And we're really pleased with the 80%, 81% volume evolution and we continue to believe that more and more physicians are understanding the value of treating these higher risk cardiovascular patients.

David Reese

Analyst · Jay Olson from Oppenheimer

And then in terms of Aimovig data at the American Academy of Neurology meeting, which is starting in four or five days, we do have what I think are some very interesting data, long term safety and efficacy data in both chronic and episodic migraine. The abstracts for those who are interested are up now. In chronic migraine, for example, we were able to show that roughly two-thirds of patients were able to convert to episodic migraine, meaning fewer than 15 migraine days per month. And on average, depending on the population and the dose, the number of migraine headache days per month was reduced by 8 to 12 days per month. That's a very substantial clinical impact for these patients, as you can imagine. So those data are coming out within the next week or so.

Bob Bradway

Analyst · Jay Olson from Oppenheimer

Those data also support the launch of the new single 140 milligram dose. So they give in that patients who got to that higher dose tends to do even better on conversion.

David Reese

Analyst · Jay Olson from Oppenheimer

Right. And there are, in those patients, complete responders, which is remarkable in this disease.

Operator

Operator

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

Michael Yee

Analyst · Michael Yee from Jefferies

Hey, thanks for the question. Good afternoon. I guess I wanted to ask a question related to two ongoing litigation issues, somewhat with the same company. One is, if for some reason the IP does not go in your favor for some reason on Enbrel, what are the implications? And what are the scenarios that we should know or for shareholders to know? And then maybe you can just comment on the separate litigation related to Aimovig, the thing that was a bit surprising to people. So maybe just comment on what the implications are there. Thanks so much.

Bob Bradway

Analyst · Michael Yee from Jefferies

Yeah, sure, Mike. I can understand that. On the first one, we feel pretty strongly about the IP case that was presented. And so obviously, if judgment were to go against us, we would immediately appeal. But on the Aimovig partnership, look, the first thing to underscore is that the teams in the field are committed to doing what's right for patients here and it's unfortunate that we have a dispute with our partner about this matter. But that's why we had dispute resolution options specified in a contract like this. So we feel that our partner is enabling a competitor product. And so we want to pursue that matter in courts, and that's where we are. But as I said, that will probably play out over a period of time. And in the meanwhile, both teams are committed to continuing to pursue this therapy for those patients who benefit from it.

Operator

Operator

And our next question is from the line of Alethia Young from Cantor Fitzgerald.

Alethia Young

Analyst · Alethia Young from Cantor Fitzgerald

I just wanted to talk a little bit about the biosimilars because I know you've had put out kind of a longer term guidance around the 3 billion number, but I just wanted now that we have some biosimilars in the market, how you guys are thinking about the prospects, do you think it’s a more attractive business, less attractive about the same, just want you to kind of frame some of the puts and takes that we can think about potential longer term value of that business?

Bob Bradway

Analyst · Alethia Young from Cantor Fitzgerald

Obviously, it's still very early days in the US based on our European experience and what we continue to believe the market outlook is, in the US, wouldn't change the long range comments we've made. Historically, I think that they still hold up. And we continue to pursue a number of really interesting and solid molecules and we continue to prepare for launches in the US in the not too distant future.

Operator

Operator

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

Cory Kasimov

Analyst · Cory Kasimov from JP Morgan

I wanted to ask on Aimovig and wondered if you could provide some color on this constipation issue that some docs and your competitors talk about with the drug. I guess I'm wondering how frequently this leads to discontinuations and what you might be doing to alleviate this, assuming it is even in fact an issue.

Murdo Gordon

Analyst · Cory Kasimov from JP Morgan

Yeah, thanks for the question. We do hear about this issue. And obviously we're always making sure that we provide necessary patient support and physician support around the safety net part of our product. But we also think on this one, there's quite a large amount of rhetoric that's been created around this issue, given how the product performed in clinical trials, the stated incidence of constipation, our label, and it'll even be reported in the long term follow up data at AAN. And so I think it's been well characterized in good, well designed and continuous clinical trials. We're also pleased that many physicians, particularly the prescribers in the large scale headache centers, are telling us that it's a relatively low incidence, and that they have very little trouble having patients started on Aimovig and persisting. I think, some of the other things we're seeing in persistence and I mentioned it in response to an earlier questioner just, given that we were the entire market for many months without competition, we are seeing some persistence effects in our continuing patient population that are different than what you might have concluded from looking at the clinical trials. And that's a function of both people who are moving from one free trial offer to another. And it's a function of people who are perhaps not pursuing commercial insurance. And obviously, there's a small component of that that is switching away to other agents. So there's still an evolving understanding of how persistent patients are to your question on discontinuation of Aimovig and it will take many months to understand that you need at least a 12 month look back period. That puts us in the 18 to 24 month timeframe before we'll be able to actually ascertain durability.

David Reese

Analyst · Cory Kasimov from JP Morgan

And Cory from a clinical perspective, I would reiterate what Murdo said, what we hear from physicians experts is that they see it at a low incidence? It's clinically quite manageable. They don't really view it as any sort of barrier at all.

Operator

Operator

And our next question is from the line of Geoffrey Meacham from Barclays.

Geoffrey Meacham

Analyst · Geoffrey Meacham from Barclays

Just had a pipeline question for Dave. Broadly on the earlier pipeline, you're still in dose escalation for BCMA, for PSMA, for KRAS, et cetera. But presumably you’ve had some evidence of efficacy and I know it's data dependent, but is there a path to moving rapidly into pivotal studies, even if it's the registration phase 2, I just wasn't sure if this was even an option or there had been discussions with regulators on this. Thanks.

Murdo Gordon

Analyst · Geoffrey Meacham from Barclays

Yeah, of course, that'll vary program by program. But what I would say in general is that our goal in these programs will be to move as quickly as we can through dose escalation and then move into expansion and potentially pivotal phases of the program. I think given the target diseases and the potential regulatory paths, that's a realistic expectation. And that's how we've planned many of the clinical development programs.

Operator

Operator

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

Umer Raffat

Analyst · Umer Raffat from Evercore ISI

I wanted to go back to KRAS again for a quick second and basically ask, based on everything you saw in the preclinical data, would you have expected to hit MTD by this third or fourth dose? And also you mentioned seeing cumulative efficacy at ASCO is what do you intend to show? Should we be expecting a dose response? And then separately on Enbrel, was curious what the net price trend was in the first quarter year-over-year adjusting for the accounting treatment? Thank you.

David Meline

Analyst · Umer Raffat from Evercore ISI

Okay. I think there were several questions, Umer.

David Reese

Analyst · Umer Raffat from Evercore ISI

In relation to KRAS, again the clinical data will present, so I won't comment on the specifics of dose response. I will say that, this is an irreversible inhibitor. And our anticipation is that achieving adequate exposure for a period of time, probably a few hours over the course of a dosing interval a day is adequate to poison the target and inhibit signaling and so our dose escalation was planned with that goal in mind and will present complete details in about a month at ASCO.

Murdo Gordon

Analyst · Umer Raffat from Evercore ISI

And Umer, on your question regarding Enbrel, we did have a strong quarter on Enbrel. It was primarily driven by a strong market across rheumatology, and we did see some net price benefit based on that price increase as well as improved contracts in the New Year.

Operator

Operator

Our next question is from the line of Ronny Gal from Bernstein.

Ronny Gal

Analyst · Ronny Gal from Bernstein

Two if I may. First, if you can break for us the relative sales of Kanjinti and Amgevita, just trying to keep track on those molecules individually. And secondly, Aimovig, Murdo, you mentioned that you’re expecting the net price stabilization of this molecule and I was kind of wondering about this comment. It seems like the payers have not really selected their preferred agency out there, even as I just added, so I was wondering if there wouldn't be another step down in pricing expected when they choose to prefer agents and then with orals coming about a year out, wouldn’t that cause another step down at pricing at that point, so I'm just -- can you put this comment in context?

Murdo Gordon

Analyst · Ronny Gal from Bernstein

Thanks, Ronny. We're not breaking the biosimilar sales by brand yet. Still a volatile market, but we are happy with both trends on both products going forward. We're also, as you look at Aimovig, my comment, if you recall, has two components to it. One is the net price reduction based on additional contracts that could occur throughout the course of the year, plus a rising percentage of prescriptions that are paid and the two offsetting one another, leading to a stable price, at least for this year. And I think that that would be my clarification to your question.

Arvind Sood

Analyst · Ronny Gal from Bernstein

Let’s take one last question and afterwards Bob will make some closing comments.

Operator

Operator

And our last question is from the line of Salim Syed from Mizuho Securities.

Salim Syed

Analyst · Salim Syed from Mizuho Securities

I guess one for me, a multipart one on Repatha, on the new CVOT trial. I guess maybe if you could just give us some color on what the genesis of the designer of that trial was, given it seems to mimic medicines companies almost like line for line. And should we be thinking of that as a validation of value proposition in the marketplace as we think about long term Repatha sales?

David Meline

Analyst · Salim Syed from Mizuho Securities

I'll be happy to address that question. Yeah. I mean, that's, we design that study, from a technical perspective, just the way we design any study, based on expected magnitude of effect, target population, all of the typical statistical calculations that go in clinical perspectives that go into study design, we weren't using anyone else’s trials, a template for that study, and I wouldn't call it validation of anything but the internally consistent results from that trial alone.

Arvind Sood

Analyst · Salim Syed from Mizuho Securities

Bob, would you like to make some closing comments?

Bob Bradway

Analyst · Salim Syed from Mizuho Securities

Okay. Thank you. Well, in closing, we're off to a good start in 2019. And I hope you share our team's enthusiasm for our long term prospects. We have a number of medicines that are in line portfolio that can and we expect will benefit significantly more patients as we grow longer term. We have an emerging portfolio of branded biosimilars, which we talked about, and we think will be a new source of growth for us. We're advancing a record number of potential new medicines in our pipeline targeted at some of the most prevalent costly and serious diseases facing society today. Our financial strength I think, is evident again, this quarter and our durable cash flows will allow us to continue to invest in the business, but also provide meaningful returns for our shareholders and deliver transformational innovation for patients. Most importantly, I want to just end by thanking our staff who are fully engaged and behind our mission and thank them for the work they did to get us off to a solid start in 2019. We look forward to talking to all of you at the ASCO investor meeting and then at the second quarter call in July. Thank you.

Arvind Sood

Analyst · Salim Syed from Mizuho Securities

Right. Thanks, everybody. If you have any follow-on questions, if we didn't get to your question or if you have comments you would like to discuss, feel free to reach out to me or other members of my team. Thanks again.

Operator

Operator

Ladies and gentlemen, this does conclude Amgen’s first quarter 2019 financial results conference call. We thank you greatly for your participation. You may now disconnect.