Amgen Inc. (NASDAQ:AMGN) 2022 Citi Global Technology Conference Call September 7, 2022 8:50 AM ET
Company Participants
Peter Griffith – Chief Financial Officer
David Reese – Executive Vice President of R&D
Conference Call Participants
Neena Bitritto-Garg – Citigroup
Neena Bitritto-Garg
All right. Well, good morning, everyone, and thank you for taking the time to join Citi’s Annual Biopharma Conference. My name is Neena Bitritto-Garg; I am one of the Biotech Analysts here at Citi. I’m very pleased to be joined for our next fireside chat with management team from Amgen. So we have the company’s CFO, Peter Griffith. We also have the company’s Head of R&D, David Reese as well.
Before we get into the discussion, if anybody does have any Q&A that you would like to ask, there may be an opportunity to do that towards the end. And with that, I want to thank both of you for being here. And I’ll turn it over to you, if you want to make any opening.
Peter Griffith
Well, thank you, Neena. Great to see everybody in person. When we got in last night, we didn’t quite know what the water was being from California; so it was nice to see a little bit of rain and get a little bit of cool weather, it’s been quite hot in California. So delighted to be here. And we’d like to thank Citi, and we’d like to ask you and like to thank you for the invitation.
So look, at Amgen, we always start with the mission for patients, committed to discovering, developing, manufacturing and distributing first-in-class and best-in-class medicines to patients all over the world. So with that, let’s get down to what’s going on at Amgen.
First of all, we executed effectively in the second quarter, 1% revenue growth year-over-year, 6% non-GAAP EPS, which excludes the $1.5 billion Five-Prime IP [ph] and R&D charge. And Q2 sales year-over-year growth was 3%, reflected 10% volume growth, partially offset by 6% on net selling price and 2% on unfavorable foreign exchange impact. Our ex-U.S. year-over-year volume growth, which is important, was 20% in the second quarter.
Second, we narrowed our revenue guidance to $25.5 billion to $26.4 billion [ph]. At the end of the second quarter, we reaffirmed our non-GAAP EPS range of $17 to $18 as we continue to execute through any number of headwinds that I don’t need to remind any of us about. Recall that in the third quarter, we expect revenue and non-GAAP EPS, the decline versus the second quarter; we said that at the end of the second quarter.
Third, on the recent drug pricing legislation, we would just say that we just don’t think the legislation does anything for patients; we’re disappointed with it, we’re disappointed for innovation for patients, we’re disappointed in access for patients. As we read the legislation, we think it does favor actually larger molecule companies like Amgen. We feel like we’re in a good position. We have one of the strongest manufacturing footprints, recall Singapore and Rhode Island; recall that we’re building in North Carolina and Ohio. We’ve got a very low cost model. We have very low cost of sales margin, very low cost of sales. So we’re — we think that will be favorable, and we’re fast. We think back to what happened during the pandemic and our opportunity to collaborate with our colleagues over at Lilly; we did it quickly and got there in about 6 months to help out on that. So I think speed will be important as we look at the legislation.
We think the world needs more innovation, not less. So across our portfolio, we have a broad pipeline of innovative and biosimilar products that are meeting the needs of lots of patients, millions of patients globally.
The second quarter reflected volume-driven growth for key products; Repatha, OTEZLA, Prolia and EVENITY, all delivered double-digit sales growth, driven by strong volume growth. KYPROLIS, BLINCYTO and Nplate; all delivered record quarters. Our launches of LUMAKRAS and TEZSPIRE are off to great starts, record quarterly sales for those, of course. And LUMAKRAS now approved in over 40 countries, launched in 25, aspires addressing a broad population of severe asthma patients regardless of eosinophilic [ph] phenotypes.
The acquisition of ChemoCentryx adds a newly launched the proposed acquisition, adds a newly launched innovative product to our portfolio, TAVNEOS, which addresses a very serious autoimmune disease, ANCA-associated vasculitis; I would encourage you to talk to Dr. Reese about that, he actually is a physician, treated patients with that in a number of years ago. We think it represents great innovation for AAV patients, and probably that first innovation well over 10 years. Our decades of leadership and inflammation and nephrology will enable us to add value to the TAVNEOS launch.
In the pipeline, we’ll be able to interrogate with Dr. Reese TEZSPIRE and rocatinlimab, the anti-OX40 monoclonal antibody, Olpasiran, if you were in the previous panel in here, you listen to that. You certainly heard about that. We’re very excited about Olpasiran. We’ve got LUMAKRAS we talked about. We’ll talk about LUMAKRAS — and of course, we’ve got a big pipeline away from LUMAKRAS which is worth talking about, too. Recall that we had several biosimilars over the next several years; we expect Phase III data from our EYLEA biosimilar later this year, and we’ve already reported positive top line data for our STELARA and SOLIRIS biosimilars. We look forward to the opportunities these bring, and we are actively preparing for and excited about the launch of AMGEVITA on January 31, 2023, and our biosimilar SOLIRIS which will launch in March of 2025.
So let’s remind you that the 2022 full year outlook, also in our oncology biosimilars, Embassys [ph] at about $850 million. And Cengente [ph], we see at about $300 million; we shared that with you at the end of the second quarter, we just remind you about those, both pricing pressures driven by competitive dynamics. Long-term growth in the biosimilars business; we consistently have said, well — and predictably have looked at that as it’s going to be driven by the addition of new molecules in new markets.
So, we also have a strong balance sheet. We generate significant cash flows. It was about $8.4 billion in the trailing 12-months through June, and we retained significant financial flexibility to continue to work strategic business development.
So with that, Neena, I’ll turn it back over to you. We’re happy to get into Q&A, and we’re glad to be here and see everybody.
Question-and-Answer Session
Q – Neena Bitritto-Garg
Perfect. No, that was a great overview. And I do want to touch on essentially if possible, kind of all of those aspects of the business. But maybe just starting with your long-term guidance. So you did issue long-term guidance to 2030 earlier this year. And I guess, just given the breadth of the kind of pipeline, the existing commercial portfolio, recent launches and the legacy portfolio, how should we think about kind of the relative contribution to the long-term guidance from those — all of those different aspects, plus, as you mentioned, the ChemoCentryx acquisition as well.
Peter Griffith
Sure, that’s a great question. Thank you. So let’s start at the top of what’s now become known as the mountain chart. And frankly, it’s exciting to start at the top because that is the contributions we expect from our innovative pipeline. So included in that would be LUMAKRAS and TEZSPIRE that we talked about would be the molecules that we’ve obtained in the past couple of years would include bema, bemarituzumab — hrocatinlimab, which we just talked about, both in Phase III. We’ve got in there tarlatimab, which is a really important drug for small cell lung cancer that’s worth some discussion with Dave on that. And then we’ve got Olpasiran in there; so that’s the innovative pipeline.
So as you think about ChemoCentryx, think about that’s a risk-adjusted pipeline in there. ChemoCentryx works to derisk that because as we shared a business review, our plan is an organic plan. And so we’re excited about that innovative pipeline. That was the green portion of the mountain chart if you think back to business review. Secondly, we had Repatha, separate, broken out on that chart. We’re very excited about Repatha, multibillion-dollar franchise, as Murdo shared with you in February, and we continue to share with you strong volume growth in the second quarter. Certainly, price is under some pressure, but we just want to make sure that drug gets to everybody that it needs to get to 1 out of 3 people around the world suffer and die from cardiovascular disease. So we’re going to continue to work that hard. We see that as a wonderful and a very important medicine for patients.
OTEZLA continues to be a great medicine. OTEZLA is safe. It’s efficacious. We think of it as a post-topical prebiologic oral treatment for all aspects of psoriasis, mild to moderate. So we think it’s really, really important. — test the LOE comes in 2028, but we’re excited about the growth through then. No lab monitoring with OTEZLA. So people think about other products that might be coming out fairly soon, and we like to emphasize OTEZLA’s no lab monitoring, and it’s got coverage, I think, at about 90% or so in the United States in terms of commercial payers. So we’re excited about that.
Next, we go to biosimilars — so we indicated to you at our business review, get together that we see biosimilars more than doubling by the end of the decade. Importantly, though, 2022, when we talk about it, we see a slight dip because we don’t have anything being introduced in new markets, new molecules this year. But we’re very confident in our biosimilars franchise, we think about the strengths of patient experience, the strength of supply, the strength of our history of biologics. It all adds up and it’s very accretive to biosimilars.
And then finally, we end up at the bottom of the chart, established products, and we think about products like Enbrel. Enbrel runs its LOE in 2029, and we’re very excited about it. It’s a strong drug for patients, strong medicine. So we’re excited about what that does. Our Neulasta continues to chug along. We’ve changed — as we shared with the end of the second quarter, we kind of upped where we see that coming in this year at $1 billion to $1.1 billion, but still a great drug with the Onpro device, great for patients. So that chunk of business that established product is important. It’s olein there, and so what we like to mention too Neena [ph], that’s where we emphasize the runoff in biologics is much slower than it is in small molecules.
So that’s what constitutes what we went over at the business review day, and we’re excited about where things are going and continue to execute as effectively as we possibly can.
Neena Bitritto-Garg
Fantastic. So along the lines of kind of the recent drug pricing reform. To your point on kind of the long-term guidance and I think some of the assumptions that went into that, there was a big component that was related to kind of price erosion as well, right? And I guess, to what extent did your long-term estimates kind of factor in this sort of pricing kind of reform?
Peter Griffith
Well, I think what I would emphasize is our long-term guidance as we shared, projects declines in net price. We’ve been dealing with that for the last 3 or 4 years. Really, I think it was 2019, the year I actually came to Amgen when price kind of started to really go down. I think ’18, it may have been off a percentage point or so. And so I would share with you, we’re prepared for that. We’ve executed through it the last couple of years. We’re prepared going forward. 2022, we signaled mid- to high single-digit declines just because of the nature and the timing of the portfolio this year. We feel fully prepared to deal with a declining price environment. As I said before, our manufacturing is very, very efficient in Amgen. We have a very strong cost of sales margin. And so we feel like what we’ve established there on the manufacturing and operating side, it’s going to be very helpful for us going forward.
And we’ll continue to deal with the declines that will inevitably come. And we will continue our efficiencies in the rest of our cost components also. — digitalization is really important for us automation throughout our cost structure. And we’ve signaled that we see a roughly 50% operating margin this year and going forward, and we’re working really hard to stay there. And it’s — as you can imagine, when price declines, it takes a kickstart every year to get at that. But our permanent productivity program, our continuing continuous improvement, our broad digitalization efforts, we’re going to continue to work really hard at that, Neena, to make sure we meet what we’ve said to our investors.
Neena Bitritto-Garg
Absolutely fantastic. Just a general question on BD. I know we talked a little bit about the ChemoCentryx deal recently. But just given the current market conditions, and we’ve seen a number of deals recently, I think that were relatively unexpected. How do the current market conditions like us change maybe your thought process on deal stage, structure, therapeutic area of interest, pricing, all those sorts of things.
Peter Griffith
I think size, shape, structure, the three Ss and modalities. Look, it doesn’t change. We’re very disciplined, predictable and consistent, we think, in business development. We want to stay that way. That group is committed to staying in the areas where we have strong research, strong discovery research, oncology, inflammation, general medicine. We think that’s an advantage for us to be, as I say, precise in that stay within our areas of expertise. It’s helpful. And then secondly, we’re going to stay disciplined in terms of executing on transactions where we exceed the hurdle rate, cash-on-cash hurdle rate. We want to be very disciplined at that. We want to see opportunities where we can integrate quickly if it’s an acquisition where we think we can work closely in a collaboration like a BeiGene, where it’s just working out really, really well. I mean they’re doing a great job in the market with our commercial products; KYPROLIS, BLINCYTO and XGEVA.
We’re working closely and have worked closely with them on the oncology research side. We’ll continue to work closely with them in a number of other areas. So we want that ability to integrate quickly too. And so we think that’s — those aspects don’t change — we think we like all of you. We certainly look at the market values and think about opportunities. But we’ll continue to stay disciplined. We’ll continue to say as we like to say at Amgen, thinking of our shareholders and making sure they’re getting returns and the shareholders or the other side of the transaction aren’t just the ones getting returns. And we want to reaffirm to investors and analysts that we — capital allocation at Amgen is a fourth thought. It’s not an afterthought. So we think about a very disciplined process, right? It’s innovation, the best innovation internally or externally, and then we make our capital expenditures.
As we said, we’re building plants by way of example, very sustainability-driven, friendly plants in North Carolina and Ohio. That’s important to us. And we get to returning capital to shareholders. We’re very disciplined on the dividend side. We’ve grown the dividend every year meaningfully since 2011, when it was initiated. — strong share repurchase background. We had an ASR this year, which everybody knows about, about $6 billion. And then we get to a transaction, strategic business development, which is important, we want to deploy there and do it in a very predictable and consistent manner. That’s how we kind of think about the market. If the market comes down, it’s a good opportunity, but we’re going to continue to stay disciplined.
Neena Bitritto-Garg
Great. Now I do want to get into some of the specific programs in the pipeline and some of the commercial programs as well. So I guess maybe starting with LUMAKRAS just because you’ve had some recent data updates and we’re going to have some more data later this week, right? I guess maybe just starting actually from a commercial perspective with LUMAKRAS. What’s kind of your current thinking in terms of the market opportunity in kind of second-line non-small cell lung cancer and your latest thinking on kind of competitive positioning, just given — but there may be another competitor entering the market in the next few months.
David Reese
Yes. Let me start with the latter first. Competitively, we feel great. As Peter mentioned, we’re now approved in well over 40 countries launched in ’25. So we’ve got a global footprint. We’ve got the largest development program. We’ve now reached over 1,900 different settings, academic and community, more than 3,000 patients treated. What we hear from physicians, I talked to many of them is quite positive about the drug. It’s behaved very consistently really since we put it into the clinic. So we’re quite happy about that. As you mentioned, we’ve got the Phase III trial head-to-head against docetaxel, where we’ve announced top line data, I can’t say any more about the data today. I’m sure there’s intense interest. But because of the embargo, we’re not really able to share details there. But next Monday, at ESMO, we’ll have those data presented.
And then, the combination trials continue to march on. We’ll have additional combination data updates that we’ll provide at ESMO from the colorectal cancer program, and then we’re moving forward with combinations in a variety of settings. The one thing I’d like to highlight is lung cancer, which you mentioned. The — when we think about non-small cell lung cancer, I like to think about this in third and segregating patients by PD-L1 expression. And it’s roughly 1/3, 1/3, 1/3 PD-L1 negative, PD-L1 low to intermediate PD-L1 high. In the PD-L1 negative population, we’ve seen some intriguing data with chemotherapy, LUMAKRAS combinations or preliminary data, which we’ll present later. But based on that, we’ve had good discussions with regulators and are launching a Phase III study in that segment.
And then, we continue to prosecute a variety of other combinations, both in lung cancer and other indications. So it’s whole speed ahead on both the launch as well as the development program for LUMAKRAS; and I like very much where we’re sitting with the molecule based on its clinical profile.
Neena Bitritto-Garg
Absolutely. Great. I guess, recently, you mentioned some of the combination data. You did recently present some combination LUMAKRAS data with PD-1 that did reveal some liver enzyme elevations. And I guess maybe if you can elaborate a little bit more on your thoughts on where these signals are kind of coming from and how you’re thinking about kind of potentially balancing kind of the benefit risk with different doses and different combinations going forward?
David Reese
Yes. So as we reported at the World Congress on Lung Cancer a few weeks ago in Vienna, we did see liver function abnormalities, specifically elevations in transaminases, AST and ALT with the combination — the direct combination of LUMAKRAS [ph] with checkpoint inhibitors. This has been seen with a number of small molecules. In fact, it’s a theme that we’ve seen play out repeatedly. My guess is that it is mechanistic and that’s something that we’re working hard to understand right now. We are taking the approach of a lead-in dose of a lower dose of LUMAKRAS followed by layering in of the checkpoint inhibitor to see if that improves tolerability. When we were able to give the drugs in combination for a period of time, we actually saw a very nice efficacy data with duration of response, for example, almost 1.5 years.
So the question is, is there an optimal way to sequence and dose these agents that will allow them to be used in combination? That’s the question that we’re pursuing in the clinic right now.
Neena Bitritto-Garg
Absolutely. So I guess just thinking about kind of the broader clinical program for LUMAKRAS I mean, I guess, what studies would you kind of highlight or what settings would you kind of highlight as kind of particularly interesting that we shall be paying attention to?
David Reese
Yes. I would keep an eye on some of the colorectal cancer data, they’re coming up beyond lung cancer. And then I think moving into first line in the PD-L1 negative, as I just mentioned, with the chemotherapy combination. These groups of — these settings are going to fragment over time, and you’re going to see a further personalized medicine approach here. And so that’s really what the development program is geared to capitalize on.
Neena Bitritto-Garg
Great. That makes sense. So I guess maybe moving on to the I&I franchise. — unless there’s — I know you do have a much broader franchise, of course, in oncology. So maybe if we can actually — before going to I&I, talk a little bit about just some of the other kind of promising programs in the oncology portfolio, anything that you would highlight in particular?
David Reese
Sure. So in the BiTE program, tarlatamab or MG-757, which targets DLL3, which is expressed on the large majority of small cell lung cancers and other neuroendocrine derived tumors. This is — we presented updated data from the first-in-human study in Vienna as well. I like this molecule a lot. These are patients who are mostly third line and beyond, where the prognosis is very poor in small cell lung cancer. There are a few existing therapies and basically no effective therapies. And so we saw a response rate of 23%. But what was interesting was duration of response, which was over a year and median overall survival, which was also over a year, which is just quite exceptional in this patient population. Our investigators are really enthusiastic about the drug. We are enrolling a potentially registrational Phase II trial now that’s enrolling quite briskly. I think it speaks to the interest of investigators and patients on this molecule. So that’s, for sure, one to watch. Of course, the bemarituzumab program in gastric cancer that targets the FGFR2b receptor. This is enrolling a couple of Phase III programs. That’s moving along as well. As enrollment proceeds, I’ll give guidance in terms of timing of data expectations. So, a lot going on across that portfolio.
Neena Bitritto-Garg
Great. So now moving on to the I&I franchise. So I know that you did get a label expansion for OTEZLA into the mild to moderate psoriasis population. And the psoriasis space, I think recently, we’ve seen a number of additional approvals as well. We’ve seen some novel topical agents that have been approved kind of a broad label. I guess how are you thinking about kind of the overall kind of opportunity for OTEZLA now just given these increased kind of competitive dynamics and the broader label expansion?
David Reese
Yes. As Peter mentioned at the outset, I mean we feel great about OTEZLA. The feedback from physicians is very, very positive. — dermatologists have been using the drug for a long time. So they’re quite familiar with it. There’s no lab monitoring requirement. It’s generally easy for physicians to prescribe and use — the — I basically like to think of it now is indicated for patients who are eligible for systemic therapy. And that’s a simple way to approach it clinically. One of the — what will happen, I think, inevitably over time, and we’re seeing OTEZLA in part led the way here is that psoriasis and psoriatic arthritis are systemic inflammatory diseases. They are not a localized skin disease. — ease systemic inflammatory diseases. There are other diseases that travel with them because of the inflammation, which goes on, of course, for decades.
And so I think over time, you’re also going to see the use of systemic anti-inflammatory agents move earlier and earlier in the course of the disease. OTEZLA is very well positioned for that. And again, it’s something that physicians are quite familiar with, as Peter mentioned, familiarity, over 90% with the new expanded label. So that, I think, will be a workhorse for us and for patients for some time to come.
Neena Bitritto-Garg
I guess, thinking about, I know everybody is kind of waiting for the PDUFA for decravacitinib attic Adrian. I guess what are your thoughts on kind of competitive positioning of OTEZLA depending on whether or not that agent does get a blackbox?
David Reese
Yes. Again, we continue to feel quite good about that because of the safety profile, the lack of lab monitoring. We’re going to find out, presumably within a few days now, what the label looks like, whether there’s a black box, whether it is treated as a JAK pathway inhibitor. But my sense from talking to physicians here is that it is likely to be viewed as a biologic or in that segment of patients that are biologic eligible in initial use. So I think we feel very good about where we sit and what OTEZLA has to offer for patients.
Neena Bitritto-Garg
Great. We actually have a question from the audience. Andrew, go ahead.
Unidentified Analyst
I had a question 2 topics. First on your LP; could you outline whether you see any window of opportunity to accelerate the approval of other part I have to pronounce it will the — passes around help people away, let’s call it. But Olpasiran [ph], on the back of Novartis’ attempt to validate Lp(a) as a surrogate in their CV outcome trials, does that open a window that you could facilitate early entry whilst you’re simultaneously running your outcome trial? And to what extent could you also leverage the Bione [ph] infrastructure, which Novartis is building for Leo — so i.e., could you read their lunch, rent number one? And then second question, just on Repatha. And I’m sure you’ve looked at this, and this is just off the top of the head question. But using [indiscernible] could you actually increase the amount of volume and, therefore, extend the dosing in order to provide convenience? And I’m sure you would have looked at dove the answer is no, but I thought I’d ask.
David Reese
Yes, sure. Let me address the second one first. We are looking at that — I mean, we have a monthly injection with Repatha now. It’s the convenience of the molecule, I think, has demonstrated itself that that’s really not an issue in the marketplace or for patients right now based on what I’m hearing. In terms of the Lp(a) program, the you’re asking it would an earlier approval be possible based on Lp(a) lowering. — using the Novartis program if they demonstrate outcomes data to essentially validate the pathway. That is not a planning assumption for us right now. And if you compare the LP(a) pathway, which we heard about in the last panel, with cholesterol, there’s 5 decades, 6 decades worth of data, linking lowering of cholesterol to reduction in outcomes. In fact, we know precisely how much you’ll reduce outcomes based on the degree of cholesterol lowering. My strong supposition is that the FDA is going to require full outcomes data for approval, and that’s our planning assumption right now. Would we have conversations with them Absolutely, but I wouldn’t take that as a planning assumption. Thank you.
Neena Bitritto-Garg
And if anyone else does have questions. There is a microphone we can have from — maybe going back to the — some of your immunology programs. So I’m probably going to butcher this name this time [ph]. Our OX40 agents that you acquired. You recently announced initiation of a Phase III study and then kind of a pausing in kind of enrollment in that program just pending some changes to the study designs. So maybe if you could just walk us through what some of the changes you’re kind of considering are and why that would be helpful.
David Reese
Yes. This was based on additional discussions with regulatory authorities and with our partners at KKC, we amended or in the process of amending the suite of studies that will, we think, improve convenience for patients. I do want to emphasize that there was no new efficacy or safety data that prompted this but rather what I just spoke to. Right now, we don’t see any effects on the overall program time lines. And again, as that suite to Phase III studies and rolls, I’ll provide guidance in terms of data expectations. So it’s full speed ahead in that program with a suite of studies that will cover a wide — very wide range of patients with atopic dermatitis, age, severity of disease, whether they’ve had prior biologics or JAK inhibitors or not. So very, very pleased with our progress there. And like I said, I’ll provide guidance as we continue to enroll.
Peter Griffith
In on rocutinumab, that’s you mentioned acquired. We actually had a license arrangement with Kyocera, who we’ve successfully partnered with for any number of decades. So we’re excited about it. We love having them with the partner, as Dave mentioned. So just to clarify that.
David Reese
It’s a great partnership.
Neena Bitritto-Garg
Absolutely. So then on TEZSPIRE, I know that there was a permanent J-Code that went into effect at the beginning of this quarter. So I guess is there anything that you can kind of comment on at this point? I know we’re a bit of the way into Q3 now on what impact that’s had on commercial uptake? And then just more generally, the feedback that you’ve gotten, I guess, from physicians around like the types of patients.
David Reese
Yes. I’ll let Peter start with the J code and then I’ll talk about the feedback from the community.
Peter Griffith
Well, we can’t comment on Q3 trends right now. But what we do know is the early launch metrics remain very positive. I think we’re running 70% unaided awareness with the pulmonologists and the allergists. So we’re excited about that. Good results. It’s sir, we’re very excited about with our partners, AV. And so initial — the initial demand uptake is in line with other competitive launches. We’re prepared to say that. And so we’re excited about that. And with that, let me turn it over to Dave because I think it’s really important to hear how the physicians are looking at this.
David Reese
Yes. The feedback from both physicians and patients has been exceptionally positive, I mean, very, very positive in terms of launches that I’ve seen over the course of my career. What we’re also seeing is, I think, a few interesting trends that we’re seeing patients who both had prior biologics and are naive to biologics. We’re seeing patients across the phenotypic spectrum, meaning low versus high eosinophilic asthma, as Peter mentioned at the outset, and we’re seeing prescribing from both pulmonologists and allergists, immunologists. So I would say it’s been a very broad and perhaps broader than we had anticipated uptake right now with really positive feedback from doctors and patients.
Neena Bitritto-Garg
Okay, that’s great to hear. So I guess, I know Andrew asked about a number of other pipeline programs, but we don’t have time to talk about all of them. So I guess which other pipeline programs would you highlight either ones that are, I guess, you feel underappreciated by — the Street or ones that you’re just particularly excited about?
David Reese
Yes. We’ve mentioned a lot of the programs already. I would also highlight on the oncology portfolio, AMG-509, which is a bispecific molecule targeting step 1 in prostate cancer. We continue to accrue what I think are very interesting data from the first-in-human trial. Hopefully, we’ll present that either late this year or into the first part of next year to let people get a look at those data. But that’s, I think, a very interesting target. And again, what we’re seeing really attracts my attention there. In the general medicine portfolio beyond the Lp(a) program, AMG-133, which is a bifunctional molecule targeting the GLP-1 and GIP pathways for obesity. We heard a lot about that this pathway in disorder in the previous panel. So that’s one to keep an eye on.
Hopefully, we’ll be presenting those data at a medical congress later this year. And we’ve completed enrollment in the Phase I program through all cohorts. So we’ll let folks get a look at that. And then in inflammation, a couple of molecules to highlight AMG-592, which is an IL-2 new team designed to enhance the function and number of T regulatory cells continues to enroll patients in both lupus and also of colitis. And we’ll give guidance on data expectations there. And then finally, AMG-570, which targets a couple of pathways that our inflammatory continues to enroll to a trial also [indiscernible]. So a lot going on. I would say we’re executing very, very well across that portfolio.
Neena Bitritto-Garg
Great. Maybe circling back to kind of some of the more general topics that we were talking about earlier and in particular, biosimilars. So I guess how are you thinking about with the AMGEVITA launch, kind of balancing, of course, you’re kind of growing biosimilar presence with the fact that you do market a drug and roll right in a very similar indication. How should we think about that?
Peter Griffith
No, we think about it as we market our biosimilars as we’ve shared, and we think it’s a wonderful advantage for us, and it has been alongside the therapeutic area in which they fit. So Amgen is being handled by our INI group. And so we think that’s a great synergy to go to payers and PBMs with and so forth and have both of those on the formulary, Emera is a super drug. I mean it’s just — it’s safe, it’s a brand for many years, the LOEs in 2029, as I mentioned earlier. So we think we’re excited about continuing to work that as part of our established product portfolio. So separately, in terms of AMGEVITA, we’ve got a 5-month head start on the competition. We’re going to be ready to go on January 31 next year. And as I said earlier, we think our strength in patient experience, our history of biologics, our ability to market it and work it next to our I&I portfolio is really, really important.
So we’re pleased with both. We’re excited about both for patients. We think they’re both important medicines need for patients, and we’re excited to keep driving them both forward and getting them out there to the patient.
Neena Bitritto-Garg
Absolutely. And then I guess to the conversation we were having earlier about pricing reform, how does that impact, if at all, kind of your thoughts on pricing strategy with it?
Peter Griffith
You mean the inflation reduction?
Neena Bitritto-Garg
Yes, the inflation.
Peter Griffith
No, I think everybody is — there’s a lot more game to play on that, a lot more to understand on the inflation Reduction Act. What we do know is we’re good at large molecules. We do know that we’re quick, we can move quickly when we need to in that area. We know we’re low cost. We know that payers and PBMs have a lot of confidence in this as a company. So we think that all adds up to strength and our ability to deliver to patients. And we think payers and PBMs recognize that we’re going to continue to work really hard to continue to earn that every day.
Neena Bitritto-Garg
Absolutely. So, I know we didn’t talk about some of the other core kind of commercial franchises, but you did mention earlier, Prolia, EVENITY [ph], we talked a little bit about Repatha. I guess, maybe if you can walk us through some of the key growth levers for each of those products. I know you’ve talked a lot recently about ex U.S. growth being important for some of those products in particular. If you could kind of elaborate on that, that would be great.
Peter Griffith
Sure. So let’s start with Prolia. Prolia grew about 13% in the first half of the year. It’s a terrific medicine for osteoporosis. And so we’re excited about that. We see that as being a solid grower right through the LOE in ’25. And this allows me another opportunity to remind our colleagues here that the runoff on the biologics tends to be much slower than the small molecules. So we’re confident in Prolia and we’re confident in PROLIA physician with EVENITY, which has an LOE after the 2030 period. In EVENITY, we’ve indicated we see, on average, low double-digit growth on that through 2030. And as we said at Business Review Day, we see those 2 combining for a bone franchise where they’re stronger together, we like to say. So we think that’s really important for both of those. And then you asked to about Repatha path that we’re at 1.1 million patients and growing.
As I said earlier, it’s really, really important stay focused on that. We think having the manufacturing capacity that we have is going to allow us to make that Repatha and volume to deliver to those patients that needed around the world. So we’re excited about that. It’s got great access, and we’re going to — it’s got a great safety profile. It’s been around about 7 years now. So we think all head go on those products that you asked about, for franchise in great shape, and we’ll continue to work it hard, provides great cash flow for Amgen. As I said earlier, it contributes to that, the last 12 months, $8.4 billion free cash flow that’s so important for us to reinvest in innovation, both internal and externally.
Neena Bitritto-Garg
Absolutely. Maybe just in the last 2 minutes here, maybe we’ll talk a little bit about because I know Peter mentioned your experience in treating patients. Just are you the Tano deal recently. So maybe if you could talk a little bit about what you see as the opportunity for that product and your thoughts from this…
David Reese
Yes. I mean the deal was predicated on the lead indication, which is ANCA-associated vasculitis and autoimmune disorder that is a small vessel vasculitis that can have various end organ effects, which can be serious, even life threatening, predominantly affecting the kidney in the lung. So a nephritis that occurs, it can actually present progressed end-stage renal disease if the disorder is not controlled and then pulmonary involvement cannot infrequently lead to pulmonary hemorrhage, which can be life-threatening. So this is — it’s a family of disorders the standard therapy has not changed in decades, which are the use of cytotoxic agents. So as a medical oncologist that was sometimes called on to administer cyclophosphamide to patients with ANCA-associated vasculitis often in the acute phases of the disease when they were quite ill.
So this molecule TAVNEOS affects the complement pathway, which is activated in no-associated vasculitis. We like the clinical data. There are 8,000 or 10,000 patients who’ve got either severe active disease or relapsed disease in the relapsed setting, the disorder can be quite serious and again, sometimes like threatening. So we just — we’ve got decades of experience in inflammation in nephrology that was right in the wheelhouse for that, and we just thought it was a great opportunity for us to really help deliver this medicine to a lot of patients who need it.
Neena Bitritto-Garg
Really fantastic. Well with that, I think we actually are out of time. So I want to thank both of you for taking the time to join us.
Peter Griffith
Thank you, Neena. Thanks for inviting.
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