Amgen Inc. (AMGN) Earnings Call Transcript & Summary

My name is Julianne, and I will be your conference facilitator today for Amgen conference call to discuss new top line data in inflammation and rare disease. [Operator Instructions] I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin.

Thank you, Julianne. Good afternoon, and welcome, everyone, to our call today. Jay Bradner will start by sharing important updates on rocatinlimab and UPLIZNA, and will be joined by Murdo Gordon and Vikram Karnani, for the question-and-answer portion of the call. Today's discussion will be accompanied by slides shared live through the webcast presentation. Those slides will be made available to all of you at the conclusion of the prepared remarks through the Investor Relations section of Amgen's website. Through the course of our discussion today, we will make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results can vary materially. Let me now turn the call over to Jay.

Thank you, Justin, and thank you all for joining this discussion today. Before we begin with the discussion of new clinical trial data, we're delighted to share the news that we've today just announced the marketing authorization of TEPEZZA for active thyroid eye disease in Japan. We're very pleased that patients suffering from active TED in Japan will soon have access to such a clinically meaningful medicine. Today, we're pleased to share and discuss results from 2 late-stage studies from Amgen R&D, the HORIZON Phase III trial of rocatinlimab in atopic dermatitis and the MINT Phase III trial of UPLIZNA in generalized myasthenia gravis. We will also offer up some reflections on prior results in IgG4-related disease with UPLIZNA and the opportunity we see for further impact in autoimmune conditions. Next slide, please. Transitioning then to our rocatinlimab ROCKET Phase III program update. Atopic dermatitis is a chronic immune-mediated condition that affects over 30 million people worldwide. And patients with moderate to severe disease have few effective long-term treatment options. There has been of late meaningful progress in therapeutic development for atopic dermatitis, but there is still a significant unmet medical need. The prevalence of this disease well quantifies the disease burden, affecting 15% to 20% of children and up to 10% of adults in the United States alone. Beyond the United States, atopic dermatitis is a global challenge. 1 of 3 people worldwide with atopic dermatitis will endure moderate to severe disease. For patients, atopic dermatitis is quite unpredictable, characterized by erratic flares, challenging quality of life and sometimes mental health. The most common symptoms associated with moderate to severe disease are itch and pain. And over half of patients with moderate to severe disease have inadequately controlled disease despite all currently available therapies, and that includes existing biologics. Rocatinlimab is a potential first-in-class treatment that specifically targets key immune pathways involved in disease progression, offering a hope to patients with difficult-to-treat forms of atopic dermatitis. T cell imbalance is fundamental to the root cause of many inflammatory conditions, including atopic dermatitis, where autoreactive T cells react to healthy skin tissue in atopic dermatitis, amplifying in number and accentuating the inflammatory response. Rocatinlimab is a monoclonal antibody therapeutic, targets the OX40 receptor to remove activated pathologic T cells. Removal of reactive T cells has the potential to rebalance the immune system in this disease and potentially across a meaningful spectrum of other inflammatory conditions. Notably, rocatinlimab does not target naive or resting T cells, those that do not express OX40, establishing the possibility of an excellent tolerability profile. Next slide. As shown, we are pretty exploring rocatinlimab in 3 indications: atopic dermatitis, asthma and prurigo nodularis. In atopic dermatitis, the ROCKET Phase III development program is an extensive program. It includes 8 studies to support regulatory submissions in this disease alone. In total, the ROCKET program evaluates the efficacy, safety and tolerability of rocatinlimab monotherapy and combination therapy in adult and adolescent patients along with different doses and dosing regimens with over 3,100 patients enrolled to date. All studies characterize the impact of rocatinlimab in moderate to severe disease, specifically in patients who had an inadequate response, contraindication or intolerance to topical medicines. Today, we will discuss the first Phase III study called the HORIZON study. Further trials are well underway to assess [ informed ] response well into 2025 to fully investigate both the initiation and maintenance uses of rocatinlimab in atopic dermatitis. As shown on the next slide, the ROCKET HORIZON study is a Phase III randomized, placebo-controlled trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis. The study enrolled 726 adult patients who were randomized to receive rocatinlimab every 4 weeks with a loading dose at week 2 or placebo for a total of 24 weeks. End points were assessed at week 16 and again at week 24. Detailed inclusion and exclusion criteria, key design considerations are outlined on this slide for your interest and for your reference. Two co-primary endpoints were utilized in this study comprising the U.S. and ex-U.S. regulatory standards, EASI-75 and either VIGA or RIGA, and these are defined herein. EASI-75 is the Eczema Area and Severity Index, where a 75% improvement from this multiparametric analysis would comprise a response on this trial. VIGA is a Validated Investigator Global Assessment, the simplified, subjective, 5-point clinician assessment of overall severity of atopic dermatitis, focusing on a global evaluation of skin appearance. The Revised Investigator Global Assessment, or RIGA is a slightly more stringent measure of the efficacy than VIGA based on a more narrow definition of 1, meaning almost clear. Achievement of RIGA1, almost clear, requires that disease be limited to just barely perceptible erythema, while VIGA1 almost clear allows for barely perceptible events of erythema. So there are some subtle differences but these are well employed and regulatory standard co-primary endpoints. Next slide, please. The Phase III HORIZON study rocatinlimab met co-primary endpoints and all key secondary endpoints, achieving statistical significance versus placebo at week 24. In the rocatinlimab group, 32.8% of patients achieved a better than 75% reduction from baseline by EASI-75 compared to 13.7% in placebo-treated patients. 19.3% of patients in the rocatinlimab group achieved a response by VIGA score of 0 clear or 1 almost clear, with a better than or equal to 2-point reduction from baseline compared to 6.6% in placebo-treated patients. The more stringent RIGA scoring system used in the United States demonstrated a comparably statistically significant benefit to patients where 16.4% of patients in the rocatinlimab group achieved a score of 0 clear or 1 almost clear, with a better than or equal to 2-point reduction from baseline. This compares favorably to 4.9% in placebo. Safety findings for rocatinlimab in this setting were consistent with those seen in the Phase IIb atopic dermatitis study that has been multiply presented and considered. Further analysis is ongoing, and we, along with our partners, Kyowa Kirin, plan to share full results at an upcoming medical congress. Next slide, please. HORIZON is the first Phase III readout and 1 of 8 studies designed to provide a complete understanding of rocatinlimab's profile in atopic dermatitis. Outlined on this study are the key upcoming data readouts for rocatinlimab in atopic dermatitis which, as you can see, extend into 2025. We look forward to sharing results of these additional studies in the future. Next slide, please. Now transitioning to UPLIZNA, I'll provide an update on IgG4-related disease and new data in generalized myasthenia gravis. Next slide, please. B cells are part of the adaptive immune system. They play a critical role in humoral immunity. Elaborating antibodies to protect against infections, antibody production, antigen presentation to pathologic T cell cytokine production to amplify and focus immune responses are all normal everyday functions of B cells. Normally, B cells use these functional capabilities to defend us against foreign pathogens. But in pathological conditions such as autoimmune diseases, B cells orchestrate an attack on our body's own tissues, often with auto-reactive monoclonal antibodies directed at proteins on the surface of healthy cells. UPLIZNA is a humanized monoclonal antibody that targets CD19, expressed on a broad swath of B cells, and so UPLIZNA is designed to deplete this broader swath of inflammatory B-cells in inflammatory conditions. UPLIZNA been designed to confer a sustained CD19 B-cell depletion that might require less frequent dosing. Indeed, a convenient every 6-month dosing interval minimizes patient impact and enables long-term adherence to sustained and hopefully beneficial UPLIZNA therapy. UPLIZNA's been bioengineered to provide efficacy in those that may have diminished responses to other monoclonal antibody therapies and has a humanized design to decrease immunogenicity, improve tolerability and reduce the risk of infusion reactions. The clinical effectiveness of UPLIZNA has been well demonstrated in trials where it already has been shown to provide a 75% reduction in the risk of developing relapse in patients with clinical neuromyelitis optica spectrum disorder, or NMOSD, with an acceptable safety profile. Next slide, please. We recently reported impressive Phase III data in IgG4-related disease. Let me first remind you of some of the study highlights and the disease characteristics. IgG4-related disease is a lifelong systemic inflammatory condition that can affect nearly any organ in the body and typically impacts multiple organs. IgG4-related disease is characterized by CD19 positive B cells that overproduce IgG4, creating a massive influx of IgG4 positive B cells into organs. This results in tumor-like inflammatory masses and associated tissue fibrosis that can cause permanent organ damage. In fact, 60% of patients may have irreversible organ damage at diagnosis and IgG4-related disease patients have a 2.5-fold higher risk of death compared to the non IgG4-related disease age match population. Currently, there are no U.S. FDA-approved therapies for IgG4-related disease, which is primarily managed then with moderate to high-dose steroids and off-label therapies. And those steroids can induce remissions. Patients are challenged by chronic steroid requirements, and often, steroids fail to prevent relapse. We're now delighted to share the clinical trial results from our study of IgG4-related diseases again. As in June 2024, we announced positive results from a Phase III clinical trial that demonstrated an 87% reduction in the risk of IgG4-related disease flare compared to placebo in 135 subjects. This was associated with a hazard ratio of 0.13 and a deeply significant -- statistically significant p-value during the 52-week placebo-controlled period of the study. Importantly, no new safety signals were identified for UPLIZNA in this setting. The overall safety results during the placebo-controlled period of the trial are consistent with the known safety profile of UPLIZNA. Based on these data, UPLIZNA was recently granted Breakthrough Therapy designation for IgG4-related disease by the United States FDA. We are extremely excited about the potential for UPLIZNA in this setting and are actively working on regulatory filing activities. Next slide, please. Turning now to another important neurologic condition that shares a similar underlying autoantibody pathology is generalized myasthenia gravis. Generalized myasthenia gravis is a rare, chronic autoimmune disease that causes fluctuating and progressive muscle weakness that can reduce quality of life can cause significant disability. There are 2 main types of generalized myasthenia gravis, acetylcholine receptor-positive autoantibodies and muscle-specific kinase positive autoantibodies. In the case of AChR autoantibodies, there's damage to the neuromuscular junction, the way that nerves communicate with muscles leading to muscle weakening. In the case of muscle-specific kinase autoantibodies, they interfere with clustering and signaling of the receptor, leading also to muscle weakness, an end common pathology. Common symptoms include weakness, fatigability, drooping eyelids are common and with generalized disease, can be difficulty swallowing, trouble breathing, impaired speech and disability from muscle weakness. There are treatments available, but there's significant unmet need. And importantly, patients could stand to benefit from more durable response, less frequent dosing and new medicine that would allow the tapering of steroids as these patients as well often endure the chronic use of steroids and their associated unfortunate symptoms. UPLIZNA has a unique mechanism of action that targets upstream disease pathobiology, and therefore, address all of these unmet needs. Next slide, please. The MINT study is a Phase III randomized double-blind placebo-controlled parallel group study of 238 patients, I believe, the largest prospective Phase III to date in generalized myasthenia gravis. The MINT study evaluates the efficacy and safety of UPLIZNA in adult, anti-acetylcholine receptor and anti muscle-specific kinase antibody-positive myasthenia gravis subjects. Currently, the majority of FDA-approved medicines are for individuals with AChR positive myasthenia gravis. The MINT trial has included the largest MuSK positive population study to date in a placebo-controlled trial. On this study, as shown, patients were randomized 1:1 to receive either IV UPLIZNA or placebo and were stratified by antibody status, AChR versus MuSK-positive, regions, Japan versus non-Japan and baseline corticosteroid use. The duration of the randomized controlled portion of the study as shown is 52 weeks for the AChR antibody positive population and 26 weeks for the MuSK antibody positive population. As we'll discuss today, the primary analysis was conducted when all subjects completed week 26 or discontinued early from the study before the randomized week 26 period. Prior to the week 26 primary endpoint then, subjects received 2 doses of UPLIZNA on day 1 and day 15, with subsequent dosing of UPLIZNA every 6 months. Next slide, please. We're pleased to report Phase III results from this study, which we perceive as a major advance and possibly practice changing with a novel mechanism, rapid and consistent efficacy and best-in-class dosing. We observed a clinically meaningful and statistically significant change from baseline in the predominant myasthenia gravis activities of daily living score, so-called MG-ADL for UPLIZNA as negative 4.2 compared with placebo, negative 2.2 for a difference of negative 1.9 at week 26 for the overall study population. This includes MuSK-positive and AChR positive patients with the goal of tapering steroid use to 5 milligrams per day. 4 out of 5 key secondary endpoints were statistically significant and all were clinically meaningful. A key secondary endpoint, a QMG score, more of a patient-reported outcome at week 26 in the overall study population also demonstrated a statistically significant negative 4.8 overall improvement compared to negative 2.5 with placebo. We're excited about this data and the potential to address the continued unmet need in generalized myasthenia gravis. This excitement is -- rests in the novel mechanism. Targeting the B-cell compartment durably and deeply versus a transient inhibition of complement or FcRn, rapid and consistent efficacy, efficacy achieved after only 2 doses of drug maintained for 24 weeks after that second dose irrespective of AChR or MuSK-positive status, and best in class dosing, twice annual dosing with the opportunity to reduce patient exposure to steroid burden and toxicity would comprise a major advance. We plan to present additional data from the MINT study at the American Association of Neuromuscular and Electrodiagnostic Medicine. The annual meeting held October 15 to 18 will be in Savannah, Georgia. In conclusion, we've now generated compelling Phase III data for UPLIZNA in 2 new disease areas beyond its approved indication in NMOSD. This further strengthens our conviction in our recently added rare disease pillar which has multiple exciting products that are early in their life cycle with the potential to reach many more patients. It is, in conclusion, an exciting time here at Amgen. We're reaching many more patients around the world with our existing medicines and advancing a broad range of important medicines in our mid- and late-stage pipelines. We have great confidence we're on a path to deliver attractive long-term growth through the end of the decade and beyond from the breadth and depth of opportunities across all 4 of our therapeutic pillars, general medicine, oncology, inflammation and rare disease, each of which have strong momentum and plenty of room to grow. I'll now turn it over to Justin for Q&A.

Thank you, Jay. As Jay noted, it's an exciting time at the company with great breadth and depth of opportunities across all 4 of our therapeutic areas. In terms of the Q&A, let me ask our Q&A participants to please focus your questions on the topics covered today, namely rocatinlimab and rare disease. The IR team will be available after the call to cover any questions beyond those items. . Julianne, if you would please kick off the Q&A session and remind our participants of the procedures.

[Operator Instructions] Our first question comes from Yaron Werber from TD Cowen.

Congrats on all the data. Maybe, Jay, my first question is, can you just give us a sense, for the MINT data, the negative 1.9 point which looks good. What's the breakout between MuSK antibody positive and acetylcholine receptor positive? And if I can just sneak in a question for rocatinlimab, what percentage of patients were previous biologics experienced?

Thank you, Yaron. Further details around the MINT study will be discussed at the appropriate time. As I shared, the MINT trial demonstrated a clinically meaningful and statistically significant benefit to both patients with AChR positive and with MuSK-positive cohorts analyzed collectively and separately. And at the right time, we'll have a chance to quantify and dimensionalize this for you. This study did anticipate and account for patients with a prior biologic experience, and the proportion of such patients will again be discussed at a later time.

Our next question comes from Michael Ye from Jefferies.

Congrats on the data. Maybe just on rocatinlimab, can you comment about the percent of patients who had prior biologics but comment on the quality of data. Is it consistent? Is it a group that you're excited about? And that would be an important differentiation. Is that -- how would you think about differentiation in this given that obviously Dupixent is out there.

Yes. Thank you, Michael. As we have discussed previously, rocatinlimab, clinical investigation has allowed for patients with prior biologics exposure and we're interested to characterize this medicine in that setting which is so important for patients. We will have a chance to dimensionalize that for you at a later time. But suffice it to say that all such analyses are included in the complete data set.

Our next question comes from Salveen Richter from Goldman Sachs.

With regard to UPLIZNA, could you just speak to your expected commercial strategy and where you see this drug is best positioned in particular, given the benefit of removing steroids and the comparable overall benefit versus the other FDA-approved therapies. Maybe just help us understand and put this in context in the treatment paradigm.

Yes, thanks for the question. So looking at the data and actually looking at UPLIZNA in myasthenia gravis, first of all, I think it's useful to understand that UPLIZNA has a pretty unique and differentiated profile, which makes it a very meaningful treatment option for MG patients. Specifically, it has a differentiated MOA, as Jay said, that works upstream of FcRn inhibition as well as [ complement ] inhibition. It offers very durable efficacy with an every 6-month IV dosing schedule, which is really important for a chronic disease, especially for -- from a point of convenience for these patients. As we also talked about, this was one of the -- this was -- we looked at patients across both serotypes, AChR positive as well as MuSK-positive patients. MINT showed strong efficacy while simultaneously tapering down corticosteroid use with the goal of 5 milligrams per day by week 24. As is probably commonly known, steroids are often used to treat myasthenia gravis patients, but prolonged high dose steroid use can have pretty harmful effects. All of our competitor trials allowed patients to remain on background therapy, including steroids. And then finally, UPLIZNA has a pretty well-established safety profile in other indications, namely NMOSD. In MINT, no new safety signals were identified. The overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of UPLIZNA. So I think at this point, what I would say in summary is that UPLIZNA, based on the data of MG patients from the MINT trial presents a really compelling option for physicians as well as patients.

Our next question comes from Umer Raffat from Evercore ISI.

I have a couple, if I may. First, Jay, I realize you're pointing us to the actual presentation for any details of the trial. So I'll spare that. But instead, let me just ask you this. As we think about the efficacy delta you reported, which is about 2 points on MG-ADL. I'm assuming that's fairly consistent over the course of the trial. So how do you put that in perspective relative to data sets seen with FcRns where it expands over the course of the first 4 weeks in the cycle, then it kind of shrinks when you're kind of off the drug within the same cycle. How do you put that in perspective? I'd be very curious about your thoughts on that. And secondly, maybe I missed it, but what do we know about fever and chills on OX40. I feel like that was a very important thing that everyone was focused on.

Yes. Thank you, Umer. And I really appreciate your encouraging words about the studies. As I had shared in the remarks, but I'm happy to double-click. The kinetics of response to UPLIZNA myasthenia gravis demonstrated rapid and sustained response. This marries up very nicely to the expected hypothesis that led to the conduct of the study. And we hope to enjoy further sustained response with the third treatment on month 6 You are right, we won't further dimensionalize the primary outcome here today. But we do think that this medicine stacks up nicely even in a field where there's been incremental progress to date. The average maintenance for a biological use with a patient is 1.5 to 2 years. Most patients receiving a biologic might try 1 or 2 options before they exit this segment of the market or are fortunate to find something that works. And patients really spend a limited time on the current treatment paradigm. 26% of patients will spend less than 6 months on a therapy. And so with the strength of this benefit -- as you know, the scales we're talking about, a difference in 1 point can mean the difference of [ feeding ] yourself or not. We think UPLIZNA has a very unique and differentiated profile. It's going to make meaningful treatment option for patients and attractive for physicians to prescribe as well. Regarding fever and chills with rocatinlimab, as I shared, rocatinlimab performed as expected on this clinical study. The anti pyrexia and chills associated was mild and manageable. And we are encouraged by what we saw from rocatinlimab in this first clinical trial.

Our next question comes from Michael Schmidt from Guggenheim.

I just had another one on rocatinlimab. Jay, if you could comment perhaps a bit more how you see the therapy fitting into the treatment landscape, perhaps relative to other biologics beyond Dupixent, which are entering the market and any comments on perhaps other clinical features in terms of things like itch relief or speed of onset, anything differentiating that you're seeing.

Thank you very much. And as I shared, rocatinlimab achieved a statistically significant outcome in the co-primaries as well as in the all key secondary end points, many of which -- most of which feature symptomatic, lesional and rash skin involvement related measures. And so more to follow on this. Murdo, I'd love to get your insights. I would say that rocatinlimab has a strong potential to be differentiated as a novel mechanism of action. It's the only T-cell rebalancing therapy. There is a high unmet need for new treatments in this disease that patients suffer from and lived with for a long, long time. There's only so much we can learn from this first study. We have 7 more ROCKET studies to learn from that I think will really help us definitively answer your question. But we see in this study unambiguous activity in the atopic dermatitis patient. Murdo, what are your thoughts?

I don't see it differently, Jay. We've got a high unmet medical need here in atopic dermatitis with only a couple of systemic therapy mechanism of action options in the market as approved today. And we'll continue to develop rocatinlimab, as you mentioned, as a unique mechanism of action being the first and only T cell rebalancing OX40 receptor targeting therapy. So more to follow, but nice to have a successful trial in already.

Our next question comes from Gregory Renza from RBC Capital Markets.

It's Anish on for Greg. Congrats on the data and developmental progress. Just on rocatinlimab, with the data today and in the context of real-world use, how should we be thinking about potential impacts to durability and long-term profile of roca if patients were to be off drug for a few months, say, for a summer drug holiday? And just as a supplement, you mentioned full data at a medical congress. Curious if you have any more granular data in between the 16 and 24 week endpoints to gauge the rapidity of response?

Well, Anish, thank you very much for the question and the interest in roca. We will -- yes, the second question first, yes, in the fullness of time, we'll have a chance to share the observations at 16 to 24. This can be very helpful to understand the kinetics that led to the statistically significant outcome as well as to assess whether there is ongoing and progressive response to this therapy. Depleting the pathologic T cell has this theoretical chance of being a very durable way of impacting patients with atopic dermatitis. And so you are right that important to understand the full potential of this medicine is both the magnitude and proportion of response as well as its durability, all of which are very important attributes that we're following closely.

Our next question comes from James Shin from Deutsche Bank.

For the mid data, how would you weigh this asset versus potentially exploring BLINCYTO in autoimmune indications?

James, this is a very thoughtful and timely question. As we've shared in our last earnings call, appearing now on clinicaltrials.gov is our first disclosure of an effort to characterize CD19 directed therapy for an expanded group of autoimmune diseases. We are very excited about this. As truly an industry leader with 2 FDA-approved CD19 directed therapeutics that have in common, a capacity for deep and durable depletion of the full CD19 compartment, we're in a very special position to characterize the difference between an afucosylated, infrequently dosed antibody, namely the parent molecule inebilizumab for UPLIZNA as well as blinatumomab, the CD19 CD3 bispecific T cell engager or BiTE therapy, which is presently has a market authorization for use in acute lymphoblastic leukemia. The clinical experience with these 2 medicines arises one from the autoimmune and rare disease world and the other from the cancer world. But in this master protocol that we have initiated, we'll have a chance to assess the safety, efficacy and tolerability in cohorts of patients with autoimmune diseases. There is something very attractive, I will say as a hematologist about this endeavor, and that is that there are signals from CD20 directed antibody use in a number of autoimmune conditions. But CD19 positive B cells is a broader swath. It covers more immature B cells that can just be initiating the elaboration, the selection of autoantibodies as well as more mature plasma blasts. So this could be a much more powerful way to approach diseases that have been only partially ameliorated by CD20 and some diseases where CD20 has just not been active enough. Both of these medicines allow for also the pharmacodynamic characterization of just how deep and just how durable the depletion of the CD19 compartment really is. And so James, we're -- as you could perhaps read through my tenor on this question, we're very interested to characterize the full impact of CD19-directed medicines for patients with autoimmunity, a major undertaking in our R&D group right now.

Our next question comes from Mohit Bansal from Wells Fargo.

It will be hard to beat James' question, but I'll try. My question is regarding the place or where do you see UPLIZNA fitting in the treatment put for paradigm. So I'm asking because Vyvgart has a really fast onset of action. And obviously, we are doing cross-trial comparison, but it has probably better benefit as well if you do cross-trial comparison. But then in the third line or so, you have complement inhibitors, which are probably -- which are subcu at this point. So do you think a 6-month dosing advantage could play or compete against complement inhibitors? Or do you think it has a second line therapy competing against Vyvgart as well?

Well, thank you for the question, Mohit. Vikram, where do you see a medicine that is quite efficacious, infrequently dosed, provides a durable benefit and has a strong impact even amidst the tapering of corticosteroids for a chronic autoimmune condition? Where do you see this medicine fitting in?

Well, look, I think -- thank you for the question, Dr. Bradner. Look, the fact is that the -- as we started out by characterizing these patients, you have to keep in mind that these patients are in spite of the fact that there might be other treatments out there, there is still significant unmet need that remains in this marketplace. These are patients that very often cannot perform activities of daily living. And the idea of having a -- or the notion of having a treatment that is administered once every 6 months that has sustained response, potentially sustained response is -- absolutely has a place in the treatment paradigm for patients as well as from a physician standpoint. We see this in other areas as well. And we've seen continue -- in many areas where take NMOSD as an example, where UPLIZNA is currently indicated, we see -- we hear from our physicians as well as directly from other stakeholders, including patients, that the once every 6-month dosing offers a pretty compelling advantage and a pretty compelling offer for patients. It allows them to manage their daily living while continuing to avail of the important impact and the benefits of the medicine. As was shared earlier, there are patients that, in spite of being on treatment, spend limited time on their current treatment. In many cases, about 1/4 of those patients spend less than 6 months on that treatment. So there is still, in spite of other treatment options being available, a fair amount of change that occurs with biologic patients. And as has been said earlier, the unique and differentiated profile of UPLIZNA will make it a meaningful treatment option for both physicians as well as patients. And let me remind you, in addition to everything that has been said earlier about the efficacy measures, et cetera, let's also not forget that the steroid taper aspect of this trial was an important finding because getting down to a goal of about 5 milligrams per day at week 24 can play a pretty important role in reducing steroid burden and toxicity. So all in all, we believe that this medicine will provide a very clinically meaningful and potentially clinical practice changing option for patients.

Our next question comes from Trung Huynh from UBS.

Just a couple on UPLIZNA. So it was originally approved in June 2020. Just can you confirm when that U.S. exclusivity goes? And then I hear your enthusiasm in B cell-mediated diseases, perhaps beyond NMOSD and the two presented today. But with that exclusivity in mind, is this more of a combination of strategy with BLINCYTO more favored than a monotherapy with UPLIZNA?

Trung, on the exclusivity, we can take that as a follow-up. And we regularly provide those dates as part of our public filings. So I think there would be nothing that we would have to share on that today. But I can turn it over to the team for the other questions.

Yes. Thank you for the question, Trung. We haven't disclosed as yet the full rationale and strategy for the use of CD19 directed biotherapeutics in the treatment of autoimmunity. You will see in the fullness of time that some of these studies are signal-seeking proof-of-concept and others could mature quickly to a registrational strategy. It's notable that UPLIZNA, for myasthenia gravis, is a Phase III study that was conducted without the guidance of an [ anti-CD19 ] Phase IIb study. And so it will be different horses for different courses. But we'll get back to you on the matter of the UPLIZNA exclusivity period.

Our next question comes from Evan Seigerman from BMO Capital Markets.

I have one for Jay and one for Murdo. So Jay, can you walk us through the rationale of targeting the receptor for OX40, say, versus the ligand? And why you opted for this approach? I know it's a partnership. And then, Murdo, walk me through what you saw on this data that warrants further investment in OX40 given the competitive landscape? These 2 biologics, JAK inhibitors, where does this fit? And I know it's been asked, but I'm wondering what you've seen in your own kind of market research that highlights the unmet need?

Thanks, Evan. Murdo, I'll get started on OX40. As you know, Evan, from following our portfolio closely, there are indeed times that we'll go for the ligand. I think that TSLP is a great example of that with TEZSPIRE, where by blocking TSLP signaling, we're able to impact a whole host of downstream cellular responses, and that can be a heterogeneous group of cells. And so for some ligands, this is a more attractive hypothesis to test in therapeutic science. Here, we're targeting OX40 itself not just to bind and inhibit OX40 signaling, which is what an OX40 ligand muting biotherapeutic would do. But rather to engage OX40 to take out the pathologic T cell. This is what I intended to confer with this discussion of T cell rebalancing. To deplete the whole of the T cell compartment, as we do in stem cell transplantation clinically in my old practice, is a very powerful way to suppress immune response, but there is a very narrow therapeutic index, and patients are at quite risk. With T cell rebalancing, you target the subset of the T cell compartment that expresses OX40. Those cells tend to be auto-reactive or reactive T cells. And with this rebalancing, we can achieve a strong and durable impact on T cell inflammatory conditions like atopic dermatitis, but potentially by taking out the T cell compartment, have a beneficial effect on other downstream cytokine and pathobiologic responses. And so in a way, OX40 ligand directed therapeutics are actually quite different than OX40 directed T cell rebalancing therapeutics. But we'll see in the fullness of time as studies are performed in some overlapping indications. Murdo?

Yes. Thanks, Jay. And Evan, from our perspective, we continue to feel that atopic dermatitis really has residual unmet need despite, as you mentioned, a couple of biologic therapies and the JAKs. What we see is we see physicians making a fair amount of switching decisions in as early as 3 months into a patient's therapy. They usually wait that period of time to see what the response is like. And then even if the physician doesn't make a switching decision, we often see patients stopping therapy within 12 months. So there's a fair amount of dynamic movement of patients in this market given the limited number of mechanisms to choose from, unlike in other disease areas like psoriasis or rheumatoid arthritis, where you have a plethora of options. This does remind me of the early days of those other disease states where different mechanisms of action were in development. And I think it's fair to say until we fully understand the full profile of rocatinlimab after completing, as Jay mentioned, the 7 additional clinical trials, it's hard to say exactly where this product will fit in the market. But there is a residual unmet need here that I feel good about given the clinical trial results here that we'll have a place to play.

Our next question comes from Terence Flynn from Morgan Stanley.

Great. I guess one for Jay, one for Murdo. I was wondering, Jay, if you can disclose the dose for the ROCKET study. I might have missed it. And if there was any imbalance in infections across arms? And then for Murdo, again, I know it wasn't the direct topic of this call, but there's a significant amount of investor focus if you guys plan to launch your biosimilar EYLEA at risk?

Terence, I'll take that last one first. As I mentioned in the beginning, we're just reserving questions on this call for the prepared topics. I'll take the other one over to Jay.

Yes. We've not disclosed the dose of rocatinlimab on this first study. And second, as I shared, rocatinlimab in the first of the ROCKET study, the HORIZON study, delivered the anticipated safety and infections were balanced between placebo and treatment.

Our next question comes from Gary Nachman from Raymond James.

This is Tejas on for Gary. So we were just wondering if you could talk about the filing strategy for UPLIZNA in both IgG4 disease and myasthenia gravis? And the timing of when you get those indications and how you'll be able to incorporate that commercially with the current sales team or if you'll need to expand anything there?

I'll take the first part and you can take the second part on integration with the sales force, perhaps Vikram. We're not going out with any dates on this call at this time regarding the expected delivery of a positive consideration from the U.S. and ex U.S., worldwide regulators. The regulatory engagement is well underway for IGG4. And with this myasthenia gravis data, we expect to prepare regulatory submissions as well. Vikram?

Yes. And I think the second question, if I'm not mistaken, was about both IgG4 as well as myasthenia gravis and how we're thinking about the sales force and from a launch perspective. Look, we believe that, first of all, based on the data that we've already talked about for IgG4 previously as well as the data today from -- for MG, both the data sets show us that UPLIZNA can be a very meaningful treatment alternative for these patients. As we discussed the last time, especially in the case of IgG4-related disease, there isn't another option and UPLIZNA could potentially be the first and only option for these patients. With that in mind as well as with the data that we have just disclosed on MINT, we are going to -- our plan is to fully resource these 2 important launches, and both from a sales standpoint, sales force, medical, with the appropriate number of MSLs to communicate all of those clinically meaningful and medically important messages and as well as fully resource access plan and access strategy so that patients can get access to this important medicine in these new indications. So stay tuned for more information as time goes by, but we do intend to fully resource, comprehensively resource these 2 indications on UPLIZNA.

Our next question comes from Srikripa Devarakonda from Truist Securities.

Congrats on the progress. I know we'll see the detailed data from UPLIZNA later, but just wondering how important do you think rapid onset of action is from a competitive standpoint? And as a follow-up, if I may, given the profile you've laid out for UPLIZNA in MG, do you think it could help improve the penetration of biologics into the broader MG market?

Yes. So thank you for both those questions. We think that there are several elements that are important when you think about the efficacy of a medicine, especially for MG patients, a rapid onset of action is important, but also equally important is the sustainability of that response. Patient convenience is an important factor as well, all things remaining equal. And of course, we know that the safety profile of the medicine needs to be well characterized so that both physicians and patients can avail of that medicine and its benefits without thinking about it. So I think I wouldn't specifically only anchor on rapid onset of action. I would characterize the full benefit of efficacy, which includes onset of action, but also the durability of response as something being equally important.

Our next question comes from Charlie Yang from Bank of America.

Congrats on the data. Two questions for me. Can you -- for the UPLIZNA, can you just describe, is there any differential response between the MuSK and the acetylcholine positive patients? And second question is, you mentioned about the durable response, but do you expect something that we can see similar to rituximab in the MuSK population where some patients can potentially stop the treatment after a couple of doses and have 3 to 5 years of response?

Yes. Thanks for the questions, Charlie. I'll take the second question first and the first question second. Truthfully, we don't know the answer to your second question. We're reading out here at the earliest portion of this MINT study that, as shown in the slide that we just flashed, has a randomized control period of 1:1 randomization, goes out to a full 52 weeks. So we'll learn more about durability through that window of time, especially after dose 3 is given at day 183. And then after the randomized control period, we have a preplanned open-label period with 6-month dosing, from which we'll get some ongoing durability data as well as a longer safety follow-up. And so please ask your question again in 26 weeks. And we'll hopefully have more data to share with you. But I don't mean to make light. It turns out to be really important to patients. To be off steroids, you want to be off them for a long time, to have a response, you want to have it for a long time. And though patients will experience many different medicines, the benefit of being on a stable, well-tolerated regimen for a long time is just very, very important to patients with chronic autoimmune conditions. And so we're very hopeful that UPLIZNA will prove to be one such medicine as we continue through the double blind randomized control period into the optional open-label period and hope that many patients stay with us on that part of the trial. Your first question regarding the subsets of patients with AChR and MuSK positivity, and there, you'll have to wait for the full presentation. But each of these patient populations is considered separately in the secondary endpoints. And as shared, the trial met almost all of its secondary endpoints.

Our last question will come from Brian Skorney from Baird.

This is Charlie on for Brian. Apologies if I missed this during the prepared remarks, but I was just wondering what if any kind of trends you're seeing with the steroid tapering? Is that causing any kind of rebound? With patients achieving that, are you -- what kind of effect are you seeing with the taper?

Thank you, Charlie, appreciate your question. As I did share, this study was designed -- here, by the way, we're speaking about the MINT study with UPLIZNA, just for clarity for all on the call. This study was designed as, by the way, the IgG4-related disease was studied to understand the full characteristics efficacy benefit and tolerability of UPLIZNA in patients here with myasthenia gravis off of steroids. And so there was a preplanned taper of steroids from week 4 to week 24. And we have not cut those data for consideration here today, but we too are interested to understand whether this medicine is able compared to the placebo arm to help patients off steroids faster. In the fullness of time, we'll have a chance to share these data with you.

Great. All right. Thank you, everyone, for joining the call today, and I appreciate your interest in our programs in Amgen.

This concludes our Amgen conference call to discuss new top line data in inflammation and rare disease. You may now disconnect.