Amgen Inc. (AMGN) Earnings Call Transcript & Summary

September 15, 2022

NASDAQ US Health Care Biotechnology conference_presentation 38 min

Earnings Call Speaker Segments

Geoffrey Meacham

analyst
#1

Excellent. Welcome to the BofA London Healthcare Conference. So my name is Geoff Meacham I'm in a senior biopharma analyst here at BofA. And we're thrilled to have Amgen with us and up here on stage is Peter Griffith, CFO; and Arvind Sood, Senior Director of Investor Relations. So guys, welcome to the conference. Looking forward to the discussion.

Peter Griffith

executive
#2

Geoff, thank you. Thanks for inviting us. We're glad to be here. Thank you, Bank of America. And I'd just like to open up with a few thoughts.

Geoffrey Meacham

analyst
#3

Yes, let's do that.

Peter Griffith

executive
#4

First maybe share with the group. Recall our focus on long-term growth and our sharing with the group back in February about our guidance through 2030, mid-single-digit growth, upper single-digit, low double-digit growth in EPS. We're excited about that. The long-term growth focus is on our established products on Repatha and Otezla and biosimilars and our innovative pipeline, which I'm sure we'll get an opportunity to discuss. Our focus on volume growth, 10% in the second quarter. So we're ready and have been ready for the new world of declining prices since they started to decline in 2018. As a company, we feel very well prepared to execute through that. And third, speaking of execution, a strong history of execution, 10-plus years of delivering what we said we would deliver in terms of growth and performance, and we'll continue to do that. Next, our marketed growth drivers. We talked about them there just for a moment, Repatha, Otezla, Prolia, EVENITY and so on through the portfolio. So we're excited about that and the growth we're seeing there. Biosimilars continues to be an area of strength for us. As we indicated a business review day, we expect that number that in 2021 of about $2.2 billion to more than double through 2030. So we're very excited about that portfolio. We talked about the innovative pipeline, and I'm sure we'll talk about that more today. We've got a lot of exciting things happening there, starting with TEZSPIRE and Lumicraft and coming along tarlatumab and rocotinlmab and so forth. So we're very excited, especially for patients there. And then finally, our capital asset. Capital allocation continues to be consistent and predictable. We recently announced the planned acquisition of ChemoCentryx and the molecule TAVNEOS or avacopan to treat ANCA-associated vasculitis. So that's an allocation of capital to the best innovation whether it be internal or external. So we're continuing down the path that we've laid out and Business Review Day. We're excited about it as a company. And as we always do at Amgen, we just say we're focused on patients. Mission-driven company, 25,000 colleagues and we're focused on our mission to deliver to patients with serious illnesses all over the world.

Geoffrey Meacham

analyst
#5

That's a great background. Thanks, Peter. Yes. Let's talk with the guidance, talk about that at the onset here. Give us a sense for the sort of the puts and takes on that. What is Amgen's kind of longer-term assumptions from, say, pipeline or earlier-stage product contribution? And how do you think about that on balance with, for example, the denosumab, LOE over the course of the decade?

Peter Griffith

executive
#6

Sure. Thank you, Geoff. And so when we think about the buildup of the portfolio over the coming years to deliver on 2030, we start with established products. So in that category, we have Prolia, we have Enbrel, very strong drugs and medicines that have performed well. And what we like to say on that, and of course, Prolia, denosumab has the LOE coming in 2025. That's where we like to remind people as we did at Business Review Day that even though the LOE drops off, the biologics have a much different erosion than the small molecules. So we're fully prepared to deal with that. So that established product portfolio, it was the blue section of what we now have named the mountain chart. While it slightly comes down through 2030. It provides very strong cash flow, and it's really, really important. Next, as we go up the strata, we get to Otezla, which there's certainly been some news on, we can talk about a little bit on Otezla, we think it's a great, great medicine for people with anywhere from mild to severe psoriasis. We think it's the first stop on a systemic medicine for them. So we can talk more about that later. But we see Otezla is doing really well through 2028 in the LOE there. Next, we see Repatha. We talked about it as a multibillion-dollar franchise. 1 out of 3 people in the world die of something related to cardiovascular disease. And we think Repatha is a great way and has been safe and proven over the past 7 years or so for 1.1 million patients to lower that LDL. And we've got great outcomes in testing on that results. And we also had a recent open-label extension that was very helpful in showing the earlier, the better with Repatha. Continuing up the build, we get to biosimilars. So we talked about that, $2.2 billion in 2021, we expect that to more than double. We're really excited about AMGEVITA coming, our biosimilar, January 31. We'll have a 5-month head start on the other biosimilars. We're Amgen, so we think that our advantage of our history of biologicals gives us a lot of strength there. We think our supply chain management, our ability to deliver every patient every time gives us strength in the biosimilars. We think the fact that we commercialize with our other products in that therapeutic category gives us strength and efficiency and effectiveness. So there are a lot of reasons we have high expectations for the biosimilar portfolio, 5 molecules now, 6 more coming by the end of the decade, starting with AMGEVITA, Soliris biosimilar coming in March of '25. Still are and Ile biosimilars coming between now and then and the more that we haven't yet talked about or shared about between March of '25 and the end of the decade. So finally, we get up to the innovative pipeline, Alumacraft's ASPIRE, tarlatimab, our small cell lung cancer drug, which is early, but we're excited about the data we see in it. As Dr. Reese says, the standard of care in small cell lung cancer hasn't really changed since he was a fellow on the oncology wards over 30 years ago. So the results we're seeing there are very strong. We love to chat about that. Rocutinlimab an atopic dermatitis, we're excited about that and what that will mean for the 30 million people around the world may need a systemic treatment like that for their atopic dermatitis. Olpasiran, the LP(a) drug that's got some really good data in Phase II. And so we've got a great innovative pipeline, and we're excited about that. And ChemoCentryx works to kind of derisk that innovative pipeline as we presented in the business review day. We did not include any inorganic activity. And so our opportunity to go out and do what we've always done, which is thoughtful, prudent strategic business development will only derisk the opportunity between '25 and '30 with our innovative pipeline. And so going to denosumab, we expect those 5 categories of products to help us power right through that. And we're looking forward to the growth through 2030. We've always taken on headwinds and done well with them. Certainly, I think everybody is feeling some headwinds now, and I didn't have a chance to say it, but a foreign exchange standpoint, interest rate standpoint and everything else. We've taken in -- as we shared at the end of the second quarter, we think there's probably about $500 million of FX and product sales this year that we've taken on and narrowed our guidance and respond thoughtfully to that. We're taking on a significant pop on EPS in terms of -- we talked about up to $0.45 or so from FX there. So we're at Amgen, we're going to execute hard for our patients, for our shareholders, for our staff. So some headwinds coming, but we're looking forward to taking them on.

Geoffrey Meacham

analyst
#7

Yes. And last question, Peter, just on the sort of the bigger picture when you think about the Inflation Reduction Act that sort of came after your guidance does that -- it probably doesn't inform much of your long-term assumptions in the next few years, but in the back half of the decade when direct negotiations kind of play out how, if at all, do you reflect that and kind of the long-term outlook?

Peter Griffith

executive
#8

Well, lots of game to play on that one. And -- but I would just say, Geoff, that certainly, we're taking the time to be thoughtful about that. We think in terms of both innovation and access and affordability at the counter is probably -- doesn't really hit any of those. And so it's disappointing legislation. Notwithstanding that, we've been prepared for declining prices since the came into the market in 2018 and started to drop. So we're prepared for anything that doesn't mean we're not going to stay focused on it. We're already thinking about what does it mean throughout the portfolio and the pipeline, both in the short, the medium and the longer term. But at the end of the day, we're very confident in what we're going to be able to execute on. We'll take it on. We'll figure out how to work with it and still deliver to patients and deliver to shareholders. But we know that it's going to take some time to evaluate it. We do think it probably -- when we read it, it favors large molecules. It favors low-cost production, which we're good at and it favors speed. When talk about speed in large molecules, when COVID hit, we were 6 months from technology transfer to shipping those monoclonals out the door in our collaboration with Lilly. So we feel like we know how to get that done fast. We know how to get it done on a very cost-effective basis, great manufacturing footprint throughout the world. And so we're looking forward to continuing to execute and address what's contained inside the Inflation Reduction Act. I think somebody called it the Innovation Reduction Act. We'll wait and see how that plays out. So we're focused on -- we'll stay focused on patients.

Geoffrey Meacham

analyst
#9

Makes sense. Well, let's talk about Otezla. You mentioned that upfront. So I guess the news of the week, so to speak, is the approval of Bristol's decravacitinib, talk a little bit about how you think about the competitive landscape going forward in psoriasis and maybe other indications? And does that inform kind of your intermediate to sort of long-term view of Otezla?

Peter Griffith

executive
#10

Well, we still think Otezla and [indiscernible] certainly augment what I have to say here because it's really an important product for patients. It's the only systemic approved for mild to severe psoriasis, and it's a great way, and we're confident that dermatologists will continue to have the confidence in it to put their patients on it. There's been over 700,000 patients around the world on Otezla. It's got a great safety profile. No lab monitoring. No monitoring with Otezla. And so we're confident that it will continue to be a medicine of choice for those who are moving off of a topical into a systemic. It's really the only choice right now. And we certainly have looked at what's coming into the market. It feels like it's probably priced to be more up against the biologicals. And we'll continue to work really, really hard to get Otezla out to the patients and we think the dermatologists will probably be sensitive to maybe what's contained in the -- and is still contained in the label and how TYK2s its relationship to the JAK pathway and so forth. So we'll just have to see what happens there. But we continue to be really confident. Otezla I think it's about 8 years now on the market. And we think it's done very, very well for the hundreds of thousands of patients that have taken it around the world.

Arvind Sood

executive
#11

And Geoff, maybe I can add just a couple of points. First of all, I think to Peter's point, the fact that we recently had the mild to moderate indication approved, it really gives us the full spectrum of the disease that we can now address with a Tesla from mild to moderate to severe disease. Number two, if you look at the label for Duke, there is some language in as much as they don't have a black box, but the FDA clearly points out that it is not well understood both the implications of TYK2 inhibition vis-a-vis JAK inhibition. So I think the -- just given the conservative posture that the dermatology community historically has taken I think they're bound to look at long-term safety very carefully. And on top of that, there are also some laboratory monitoring requirements in terms of elevations in liver enzymes and also elevated triglyceride levels. So kind of with that as background, if you look at the Otezla label, there are no laboratory monitoring requirements. We have been in the market for a number of years. So a very strong track record, both in terms of safety and efficacy. And again, as I had mentioned before, just given the ability to cover that broad spectrum of disease, we think bodes very well for the positioning of the product.

Geoffrey Meacham

analyst
#12

Yes. And sort of related to that, when we think about the launch of AMGEVITA next year, the pricing across the TNF space is going to come under a bit of pressure. Do you expect there to be a bit of a spillover into some of the other markets, including psoriasis, from, say, RA or some of the GI markets? Or do you think the pricing environment for Otezla is going to remain pretty stable?

Peter Griffith

executive
#13

Look, we'll see what happens with AMGEVITA. I think that's introducing a great opportunity, frankly, for patients and providers into the market. So we'll wait and see what disruption, if any, that creates. What we're planning for is the Amgen to be a terrific launch. Starting January 31, we feel great about where we're positioned. As I said before, with AMGEVITA, from a supply chain management and in our discussions with payers and PBMs, the strength we have in supply chain, the strength we have with the patient experience, the strength we have with our history of biologics, the strength we have in commercializing that with the other -- in the therapeutic category. We think that's really, really important. And we've got ENBREL. And so we think we've got an opportunity to deliver both ENBREL's a very safe and proven TNF, and we think that's going to be really, really continue to be a strong part of our established product portfolio. In terms of what happens, we're not going to comment on how we kind of think about strategy around pricing and so forth. But we know from a patient standpoint, it adds another great opportunity. AMGEVITA does, for patients and for payers and PBMs to use it. So we're excited about that. We look forward to the launch.

Geoffrey Meacham

analyst
#14

To what degree can you leverage your ENBREL or Otezla your experience in the I&I marketplace with payers to try to maybe enhance the status of AMGEVITA or -- in formulary?

Peter Griffith

executive
#15

That's a great question. We think it's very helpful. So we think that's a whole -- that's one of our thesis around the biosimilars is it augments and it amplifies what we have in our therapeutic portfolios in commercial. And so it's helpful. It makes us efficient -- we think it gives us a broader quiver of arrows when we go to deal with the PBMs and the payers in terms of what's in the therapeutic quivers. And so -- we do see that as a strategic advantage for us.

Geoffrey Meacham

analyst
#16

Got you. Okay. Let's also talk about LUMAKRAS. So just given the news of the past.

Peter Griffith

executive
#17

Well, we got 16 minutes in, Geoff, and then we got the LUMAKRAS.

Geoffrey Meacham

analyst
#18

I know. I want to set it up before we get into the -- so talk a little bit about your -- your thoughts on the data, a lot of questions that we've been getting from investors on the regulatory piece, right, with -- does the overall survival effect kind of change your view or give you some caution? Or is it just simply a matter of this is the confirmatory study and let's continue to invest in combination studies and other tumor types beyond line?

Peter Griffith

executive
#19

And let me start and really let Arvind comment on this because it's important that we interrogate this with you. and with our investors and analysts. Look, at the end of the day, it was a confirmatory trial. And met primary endpoint wasn't powered for the overall survival with the crossover that certainly wasn't leaning that way. It wasn't the purpose of it. So we're very pleased with the fact that from a confirmatory trial standpoint, that achieved the primary endpoint. So with that, we look forward to moving forward on any number of other combinations, including, for example, with Vectibix so on and so forth. We just -- we're going to do everything we can and see that the medicine gets to patients that have that KRAS G12C mutation in whatever cancer they have as data comes out and make sure they have -- we have an opportunity to produce what makes sense to get out in the market from that standpoint. So with that, I'll invite Arvind to jump in too because this is really important, was the undruggable for 30-plus years -- so we're going to continue to work it really hard. I would just add too, we've got the only approved KRAS G12C non-small cell lung cancer drug out there. It's approved in 40 countries and launched in 25. I think in the United States, we've treated over 3000 patients, and I think it's 1,900 prescribers. So it's going really, really well, and we just want to continue that.

Arvind Sood

executive
#20

No, I think you've covered a lot of ground there, Peter. Perhaps I can add just a couple of other points. If you look at certain other metrics, Geoff, within the study, the so-called CodeBreaK 200 study, I think they're noteworthy. First of all, if you look at the medium time to response, it was faster compared to the docetaxel group, which was kind of the control group. It was 1.4 months as compared to 2.8 months in the docetaxel group. If you look at the median duration of response, it was impressive. It was 8.6 months as compared to 6.8 in the docetaxel group. So on many of those metrics, actually LUMAKRAS performed better than expectations and certainly better compared to docetaxel. As Peter pointed out, this particular study with 345 patients enrolled really was powered for overall survival. And there was a crossover design. As a matter of fact, about 34% of the patients crossed over from docetaxel to LUMAKRAS. So again the study met its primary endpoint, that met a subjective in terms of being the confirmatory study. that supports the accelerated approval that we had for macros. With all that said, if you really look at the overall program that we have for LUMAKRAS, it's very comprehensive. We have 10 different combination trials, which are ongoing, and we also believe that there are multiple paths to moving LUMAKRAS to earlier lines of therapy, which is really 1 of the key questions that you and investors are focused on. And we really like to think of the non-small cell lung cancer population in 3 buckets. If you look at their population, you've got the PD-L1 high expressers, PD-L1 moderate to low expressers and then you've got the PD-L1 negative expression. And within that patient population, in particular, historically, checkpoint inhibitors have not been very effective. So that's where we feel that, again, the development program that we are embarking on is the right approach in that we are looking at monotherapy in this particular patient population, the PD-L1 negative patients and also those that are STK11 mutants, and we are also looking at combination therapy with chemotherapy or combination with chemotherapy in this particular patient population. So again, suffice it to say, it's a very comprehensive development program and again, as Peter pointed out, this is an improved product is on the market now is in 40 different markets and we have commercialized this product in about '25. And the profile of LUMAKRAS will continue to evolve.

Geoffrey Meacham

analyst
#21

Yes. And to follow up on that, Arvind, just in the monotherapy population. What's the scorecard here with regard to expansion of testing on a global basis for G12C is there a lot more runway to go. And then the U.S., do you feel like you're at the sort of the upper end of where you guys could be in terms of eligible population?

Arvind Sood

executive
#22

Yes. The testing is actually very high in the U.S. is -- I mean, 80% of the patients are not tested for their KRAS G12C status. So the testing rates have gone up exponentially. I think the challenge, and this is a part of our commercial strategy now is that there's broad awareness of this testing in the academic setting. But how do you then move it into the community setting. And that's where we really see the growth opportunity down the road. Once the physician has made the diagnosis of second-line non-small cell lung cancer to ensure that, that physician is aware of the KRAS G12C status of the patient is absolutely key. And 1 of the aspects that we have been working on very hard is to make sure that the pathology reports appropriately represent the patients KRAS G12C status that is not buried kind of in the middle or the back of the report. This is an actionable mutation and the physician, the prescribing physician needs to be made aware of the fact that this is an actionable mutation.

Geoffrey Meacham

analyst
#23

Got you. And of all the combinations, is there one that you suspect could be sort of the lead one. I mean people have mentioned SHIP2 as being probably the more likely than not to be a better combo. But maybe immunotherapy is probably also a good combo as you move forward to earlier lines?

Peter Griffith

executive
#24

So at the most recently held World Lung Conference, we presented some data on looking at a combination of LUMAKRAS with PD-1. And in this particular study, as you're well aware, the incidence of grade 3 and 4 treatment-related adverse events was actually higher with this combination, notably liver enzyme elevations. Again, not a huge surprise because historically, it's been very difficult to combine targeted agents with checkpoint inhibitors. If you look at the EGFR class, if you look at the ALK inhibitors, I mean, we have seen the same type of trends with those type of combinations. With that said, again, we are still looking at sequential therapy because what we found in this particular study is that where LUMAKRAS was used as sequential therapy in lower doses actually with the clinical outcomes were better. So we are continuing to pursue this particular study using LUMAKRAS in that form. As far as SHIP2 inhibition is concerned, again, we presented some relatively small number of patients but positive data also at the World Lung Conference. And one of the key things there, Geoff, that we are looking at is the emergence of resistance mechanisms. And I think that's going to be very important because these have emerged in patients with non-small cell lung cancer to the tune of about 24% and patients with colorectal cancer to the tune of about 27%, and being able to inhibit upstream RTK or receptor tyrosine kinase, as a mechanism of resistance, we think it makes inherent sense. So we are pursuing the combination with a SHIP2 inhibitor, because, as you know, ship 2 inhibitors tend to inhibit RTK, again, that being an upstream modifier. Again, I would go back to what I mentioned before that we are looking at a whole host of combinations about 10 different combinations, and we'll see what the data shows.

Geoffrey Meacham

analyst
#25

Right. And last question. Just with respect to the competitive landscape, I mean, obviously, people try to compare the data across between you guys and variety, but there is a lot of value in being on the market today and being -- having the commercial experience. But when you see the profiles as they are now with respect to combinations, talk a little bit about where you see the biggest points of differentiation with LUMAKRAS.

Arvind Sood

executive
#26

Right. I think you hit the key point. We are the only KRAS G12C in the market today. I think the profile is -- has been reasonably well established, both from an efficacy standpoint and a safety standpoint. And there's been the temptation to kind of draw a correlation or draw a comparison between our compound and a competing compound. And those differences have been along the lines of is it better to give the product twice a day as compared to once daily dosing is the one that we have, there are differences that have been attempted to be drawn on the basis of the PK profile on the basis of tissue penetration. But on many of these metrics, Geoff, as you know, there really haven't been any meaningful differences. So to try to establish a profile of a product based on very sparse data at this stage. I think it's a business very difficult. Again, with that said, I would just go back to the fact that we have a very comprehensive program that is ongoing. We have, I think, a well-embedded position now in second-line non-small cell lung cancer. But going forward, I think to be able to move it into earlier lines of therapy and other tumor types, those are some of the measures that we are looking at to grow LUMAKRAS.

Geoffrey Meacham

analyst
#27

Makes sense. Well, we've talked about the LUMAKRAS crest and then biosimilars, two growth franchise for you. And TEZSPIRE, is there anything to talk about there? Is it just too early in the launch with regard to having confidence in the kind of intermediate to long-term trajectory?

Peter Griffith

executive
#28

I think TEZSPIRE has been a really strong launch. I think it's been very well received by both pulmonologists and allergists. And I think most importantly, by patients with severe asthma. And look, it's very effective thus far, very good results on both high and low eosinophilic. We think that's wonderful. Good news for patients. I think unaided awareness continues in the 70% or so area for both pulmonologists and allergists. So Geoff, it's been a strong launch. And this is a really, really serious disease. And with urbanization around the world and so forth, we think we're really glad it's out there for patients. So it's going well. We'll continue to go forward on it. I think we've got 4 LCM projects on it. And so we're looking forward to those moving ahead because we think those could be really important to patients who have those indications. We'll have to see what the data says on those, but we'll remain optimistic on them that this TSLP work continues to move forward, be efficacious in dealing with these diseases. So as buyer is great moving ahead. We'll continue to work on it hard with our partner on it, and we're excited about it.

Geoffrey Meacham

analyst
#29

Got you. Well, let's talk a little bit about -- you mentioned at the onset, the M&A environment and the ChemoCentryx deal, to some degree, you're one of the leaders in the I&I space. But this is a bit of an orphan kind of indication. Is this -- does this signal for Amgen, are you going down a path more narrow therapeutic areas that maybe have better pricing or is this a platform that you think could broadly enhance the I&I category for you guys?

Peter Griffith

executive
#30

Good question. I think you shouldn't read anything into our acquisition -- or proposed acquisition of ChemoCentryx TAVNEOS or avacopan other than hits it our 4 criteria. We think we're the best buyer. We think having the relationships we've had with both rheumatologists and nephrologists for decades, just adds right into this. We think that, that commercial footprint will allow us to drive this to patients a lot faster than our colleagues who we have just tremendous respect for at ChemoCentryx had. So we're looking forward to doing that. Number two, when we looked at this, we were able to achieve a cash-on-cash return well above our hurdle rate. So we always check that off at Amgen to make sure that we're maintaining value for our shareholders, not just the shareholders, the other side of the deal. Number three, as you make the point, Geoff, it fits right into one of our core research areas, which is inflammation and immunology. And finally, number four, we always look at, is this something we can integrate thoughtfully and quickly. And certainly, with our history with nephrologists and rheumatologists and our history of being able to quickly integrate transactions, 'in this case, a proposed acquisition. We think it's something we can do, and our colleagues at ChemoCentryx, we look forward to having them come on board, and we're really excited about it. So it hits the 4 criteria, at least as I articulate them, that we look for in business development. So I don't think there's anything to read into it other than -- we always have the aperture open wide and this one looks great. We're very excited about it. And as we said, we look forward to closing it in the fourth quarter.

Arvind Sood

executive
#31

Yes. And it's a meaningful market. If you look at the ANCA-associated vasculitis, as saving this a large market, we have estimated about 50,000 to 60,000 individuals. Now within that, the proportion of patients who have the more severe form of disease of the disease and/or are resistant to existing therapies like steroids and immunosuppressant drugs. That's about 8,000 to 10,000 individuals.

Geoffrey Meacham

analyst
#32

Yes. And just on the bigger backdrop we've seen in SMD-Cap Biotech, a lot of pressure. Maybe there was oversupply with regard to new IPOs, et cetera. But how have you guys looked at the landscape? Do you think that do you expect there to be a bigger step up and more tuck-in kind of bolt-on deals. And Amgen historically has not done larger transactions. But could that be in the cards looking to the next several years as you guys start to see some of these newer technologies kind of coming to fruition.

Peter Griffith

executive
#33

It's an important question. First of all, no change in Amgen in terms of how we look at inorganic activity. We're agnostic as to stage and structure and modalities, as you mentioned, we want to go out and find the best innovation, whether it's internal or external. In terms of structure, we're agnostic. In the last 1.5 years or so, Geoff, we've done any number of types of structures from licensing to acquisitions to collaborations to outsourcing in the case of some of our neuro assets where we also invest in. So that's going to all continue to be important to us. Looking forward in terms of how the valuations are playing out in the privates and the SMDs and the potential for doing something larger. Our aperture is always open wide. We expect of ourselves to have clearly informed views on what's available in the market on a very thorough basis. And I think we have a very disciplined approach to that. We'll stick to that discipline. We'll stick to those 4 criteria that we talked about when we talked about what ChemoCentryx hit and met and drove us to make that proposed acquisition. And so we're going to continue going down the same set of processes that we've been doing. And we'll let the market fall where it may, and we'll continue to be on the balls of our feet here at this time in the market, which I think we all need to be given what we've seeing happening in the market lately.

Geoffrey Meacham

analyst
#34

Right. Yes, we've seen a number of deals that have happened in mostly across the biopharma space, they're in therapeutic areas that companies are already currently in. What's the appetite at Amgen to step outside of maybe a hem/onc or an I&I category to go into something that's a little bit more a feel just to help diversify the portfolio or the pipeline a bit?

Peter Griffith

executive
#35

That's a fair question. As of now, we're kind of -- we like the 3 categories we're in. But I'm glad you used the word diversify because I think a business review day, we talked about the company as being diverse. We've got any number of so-called blockbusters at the company already. When you look at the pie chart we put up business review day, we've got a nice balance in the 3 therapeutic areas. When we get to 2030, between onc and I&I and General Medicine, we're excited about that, good balance geographically, -- will be -- now we run about 70% U.S. and 30% outside the U.S. We think that will increase to at least 35% outside the U.S. driven by JPAC and really primarily in China and Japan. So we've got good diversification from a product and therapy standpoint. We've got good diversification from a geographical standpoint. So I think in terms of kind of sticking to what we do and we think there's plenty of room inside those kind of bookends. So we'll continue to interrogate that, and we think there's still opportunities for us there to move ahead on and prudently and thoughtfully deploying our shareholders' capital. And as I said before, Geoff, at Amgen, we want to make sure our shareholders are getting a return, not just the other side of the deal. And capital allocation at Amgen is going to continue to be a forethought, not an afterthought. And so that leads us in -- we're going to continue to thoughtfully return capital to shareholders through a dividend that's increased every year since 2011 meaningfully when it was instituted and continue with opportunistic share repurchases. So putting that all together, we think the 3 areas, the therapeutic areas we're in now, make a lot of sense for us, and we think we're really good at it.

Geoffrey Meacham

analyst
#36

Yes. Yes. And your point on the Beijing deal and your Asia PAC business overall, I mean, that should be a big growth driver looking out a few years. when would you think that would hit sort of a critical mass or an inflection point? I know your partner is highly successful commercially in Asia more broadly. But is there a time frame that you would think that, that would sort of start to really hit a growth trajectory that's well in excess of what your guidance is?

Peter Griffith

executive
#37

It's a great point. Look, we've got the NRDL for Repatha now. That's separate from the relationship, the collaboration with BeiGene. BeiGene is doing a terrific job commercializing XGEVA, KYPROLIS and BLINCYTO, our end market cancer drug. So we're really delighted with that collaboration and that work with them. So we think in terms of picking a specific inflection point, we stick to doing what we do every day, which is execute and we look up and we think JPAC will continue to grow for us. I think last year, in 2021, Arvind, we went through $1 billion in revenue October the first time. So that was exciting. And so we'll continue to move forward. I guess, $1 billion sounds like maybe an inflection to me. So pretty exciting. What's the old saying, $1 billion here, $1 billion there, sooner or later, it's real money.

Geoffrey Meacham

analyst
#38

Right. And then Peter, just to wrap up, you mentioned the pipeline, and this is something that we hear a lot from investors. They're there's a lot of interesting assets that you guys have with regards to -- you have OX40 for atopic derm. We mentioned Aspire small cell lung. What would you say -- I mean, I hate to ask this is not my favorite question, but like what is the most underappreciated? What do you think provides a lot of kind of optionality for you guys that you don't get asked about very often?

Peter Griffith

executive
#39

We love that question. And let me throw something in and Arvind can come too. Look, I'm excited about all of them. I've got 4 children at home, so I love all my children the same, but in the pipeline, I certainly look at Olpasiran, and that's exciting. I think LP(a), there's a lot of opportunity there. I get excited by Repatha and what it's doing for people with the LDL problem and I look at Olpasiran, and that one is exciting. I mean, with 1 out of 3 people in the world suffering from cardiovascular disease. Hopefully, that will -- the data on that will come out be real positive, and we shouldn't overlook that. I think that's really important. But I look at AMG 509, for stage 1 in prostate cancer. For those of us who are in the room who are on the older side of being males, I mean, Dr. Reese in her later, we all got to kind of face that music. So this deep one, AMG-509 the early data looks good. So we'll see what happens there. Arvind, what would you say?

Arvind Sood

executive
#40

No, I would probably add maybe a couple of more to that list, Peter. One would be tarlatimab, probably DLL3 targeting body. When you think of Stage III small cell lung cancer, I mean, there's nothing that has been approved for that indication. And based on the data that we presented at the World Lung Conference, a median duration of response, overall survival for about a year, I think it's quite impressive. So certainly, that's one that I would note. The other one, Geoff, that seems to be getting a lot of attention and probably for good reason, given the prominence is an earlier-stage asset that we are developing is a Phase I asset called AMG-133. And mechanistically, this is a very unique product. It activates the GLP-1, the glucagon like peptide 1 and also it antagonizes Gibber. So mechanistically is very unique from the standpoint that there's genetic basis that lowering expression of differ levels actually leads in lower BMI or body mass index and lower rate. And we presented some preliminary data at our business review that was held earlier this year. Where we showed that a single dose of AMG-133 actually resulted in a very profound weight loss 18 to 20 pounds that was sustained over a period of time. It was sustained over a 100-day period. So we are going to be presenting data with -- on AMG-133 at one of the medical conferences later on this year. This is going to be more updated data. Again, it's going to be very early data at this stage. But this is one that has also captured a lot of interest.

Geoffrey Meacham

analyst
#41

Perfect. Okay. Well with that, we're out of time. So Peter, Arvind, thank you so much. Good to see you guys.

Peter Griffith

executive
#42

Great to see you, Geoff. Thank you.

Arvind Sood

executive
#43

Thank you, America.

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