I will be your conference facilitator today for Amgen conference call to discuss new top-line data in inflammation and rare disease. All lines have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. To ask a question, please press star, then the number one on your telephone keypad. To withdraw your question, please press star one again. 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 we'll 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 a 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 the 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 two late-stage studies from Amgen R&D, the HORIZON Phase 3 trial of rocatinlimab in atopic dermatitis, and the MINT Phase 3 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 3 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%-20% of children and up to 10% of adults in the United States alone. Beyond the United States, atopic dermatitis is a global challenge. One in three people worldwide with atopic dermatitis will endure a 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 presently exploring rocatinlimab in three indications: atopic dermatitis, asthma, and prurigo nodularis. In atopic dermatitis, the ROCKET Phase 3 development program is an extensive program. It includes eight 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've had an inadequate response, contraindication, or intolerance to topical medicines. Today, we will discuss the first Phase 3 study, called the HORIZON Study. Further trials are well underway to assess and confirm 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 3 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. Endpoints 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, a simplified, subjective, five-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 one, meaning almost clear. Achievement of rIGA one, almost clear, requires that disease be limited to just barely perceptible erythema, while vIGA one, almost clear, allows for barely perceptible events of erythema. There are some subtle differences, but these are well-established and regulatory standard co-primary endpoints. Next slide, please. The Phase 3 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 zero, clear, or one, 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 zero, clear, or one, 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 2 b 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 3 readout and one of eight 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 two thousand and twenty-five. 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 cells, 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 autoreactive 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 has been designed to confer a sustained CD19 B-cell depletion that might require less frequent dosing. Indeed, a convenient every six-month dosing interval minimizes patient impact and enables long-term adherence to sustained and hopefully beneficial Uplizna therapy. Uplizna has 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 3 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 two-and-a-half fold higher risk of death compared to the non-IgG4-related disease age-matched 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 disease again. As in June 2024, we announced positive results from a Phase 3 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 and cause significant disability. There are two 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 weakness. In the case of muscle-specific kinase autoantibodies, they interfere with clustering and signaling of the receptor, leading also to muscle weakness and in 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 3 randomized, double-blind, placebo-controlled, parallel group study of two hundred and thirty-eight patients, I believe the largest prospective Phase 3 study 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 one to one to receive either IV Uplizna or placebo and were stratified by antibody status, AChR versus MuSK positive, region, Japan versus non-Japan, and baseline corticosteroid use. The duration of the randomized control 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 two doses of Uplizna on day 1 and day 15, with subsequent dosing of Uplizna every six months. Next slide, please. We're pleased to report Phase 3 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 four point two, compared with placebo, negative two point two, for a difference of negative one point nine at week twenty-six for the overall study population. This includes MuSK-positive and AChR-positive patients with the goal of tapering steroid use to five milligrams per day. Four out of five 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 twenty-six in the overall study population, also demonstrated a statistically significant negative four point eight overall improvement compared to negative two point five with placebo. We're excited about these data and the potential to address the continued unmet need in generalized myasthenia gravis. This excitement 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 two 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 3 data for Uplizna in two 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 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 pipeline. We have great confidence that 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 four of our therapeutic pillars: general medicine, oncology, inflammation, and rare disease, each of which has 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 four 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. Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, press star followed by one. Again, to ask a question, please press star one. Our first question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open. Yeah, hi, and thanks so much for doing this webinar. It's super useful, and congrats on all the data. Maybe, Jay, my first question is, can you just give us a sense for the MINT data, the negative one point nine 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. Yeah. 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. Thank you, Yaron. Our next question comes from Michael Yee from Jefferies. Please go ahead. Your line is open. Thank you. Appreciate the call, and 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? That would be an important differentiation. Is that how would you think about differentiation in this, given that obviously Dupixent is out there? Thank you. Yeah. Thank you, Michael. As we've 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'll 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. Julianne, let's go to the next question, please. Thank you, Michael. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open. Good afternoon. Thanks for taking my question. With regard to Uplizna, could you just speak to your expected commercial strategy here and where you see this drug as 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. Yeah, 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 C5 inhibition. It offers very durable efficacy with an every six-month IV dosing schedule, which is really important for a chronic disease, especially from a point of convenience for these patients. As we also talked about, this was the. 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 a goal of five milligrams per day by week twenty-four. 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. A ll 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 in time, what I would say in summary is that Uplizna, based on the data from MG, for MG patients from the MINT trial, presents a really compelling option for physicians as well as patients. Julianne, let's go to the next question, please. Thank you, Salveen. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open. Hi, guys. Thanks for taking my questions. 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 two 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 four weeks, the first four weeks in a 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. 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 in myasthenia gravis demonstrate 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 at month six. 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. You know, the average maintenance for a biological use with a patient is, you know, one and a half to two years. Most patients receiving a biologic might try one or two options before they, you know, exit this segment of the market or are fortunate, you know, to find something that works, and patients really spend a limited time on the current treatment paradigms. Twenty-six percent of patients will spend less than six months on a therapy, and so, you know, with the strength of this benefit, as you, as you know, the scales we're talking about, a difference in one 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 it a meaningful treatment option for patients, and attractive to physicians, to prescribe as well. Regarding fever and chills with rocatinlimab, as I shared, rocatinlimab performed as expected on this clinical study. Any pyrexia and chills associated was mild and manageable, and we are encouraged by what we saw from rocatinlimab in this first clinical trial. Great. Julianne, next question, please. Thank you, Umer. Our next question comes from Michael Schmidt from Guggenheim. Please go ahead. Your line is open. Hey, guys. Thanks for taking my question. I just had another one on rocatinlimab. Just, Jay, if you could comment perhaps a bit more how you see the therapy fitting into the treatment landscape, perhaps also 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? Thanks so much. No, 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 endpoints, 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. It is a novel mechanism of action. It's the only T-cell rebalancing therapy. There's a high unmet need for new treatments in this disease that patients suffer from and live with for a long, long time. You know, there's only so much we can learn from this first study. We have seven 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 AD already. Julianne, next question, please. Thank you, Michael. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open. Hey, guys. It's Anish for Greg. Congrats on the data and developmental progress, and thanks for taking our question. Just on rocatinlimab, with the data today and then 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. Just curious if you'll have any more granular data in between the 16 and 24-week endpoints to gauge the rapidity of response. Thanks so much. Anish, thank you very much for the question, the interest in Roca. Yes, to the second question first. Yes, in the fullness of time, we'll have a chance to share the observations at sixteen to twenty-four. This can be very helpful to understand the kinetics that led to this statistically significant outcome, as well as to assess whether there is, you know, 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. Right. Julianne, next question, please. Anish, our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open. Hi, guys. Thanks for the question. For the MINT 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 at 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 two 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 in 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 two 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 plasmablasts. And 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. Great. Julianne, next question, please. Thank you, James. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open. Great. Thank you very much for taking my question. It'll be hard to beat James' question, but I'll try. So I mean, I'm just like. My question is regarding the place or where do you see Uplizna fitting in the treatment paradigm. 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 sub-Q at this point. Do you think six-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? Thank you. 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? Look, thank you for the question, Dr. Bradner. Look, the fact is that, 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. The idea of having, or the notion of having a treatment that is administered once every six 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. You know, we see this in other areas as well, and we've seen continued in many areas where, take NMOSD as an example, where Uplizna is currently indicated. We hear from our physicians as well as directly from other stakeholders, including patients, that the once every six-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 a quarter of those patients spend less than six 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 five milligrams per day at week twenty-four 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. All right, Julianne, let's take the next question, please. Thank you, Mohit. Our next question comes from Trung Huynh from UBS. Please go ahead. Your line is open. Hi, guys. Thanks for putting on the call. 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 strategy with Blincyto, more favored than a monotherapy with Uplizna? Thanks very much. Hey, Trung. On the exclusivity, you know, we can take that as a follow-up, and we regularly provide those dates as part of our, you know, public filings, so I think there would be nothing new that we would have to share on that today, but I can turn it over to the team for the other questions. Yeah, 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 was a Phase 3 study that was conducted without the guidance of an antecedent Phase 2b study, and so it'll be different horses for different courses, but we'll get back to you on the matter of the Uplizna exclusivity period. All right, Julianne, let's take the next question, please. Thank you, Trung. Our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open. Hi, guys. Thank you so much for taking my questions. 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 in this data that warrants further investment in OX40, given the competitive landscape. We have two biologics, you know, JAK inhibitors. Where does this fit in? 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. Thank you so much. Thanks, Evan. Murdo, so I'll get started on OX40. Well, as you know, Evan, from following our portfolio closely, there are indeed times that we'll go for the ligands. 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. 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's a very narrow therapeutic index, and patients are at quite a risk. With T-cell rebalancing, you target the subset of the T-cell compartment that expresses OX40. Those cells tend to be autoreactive 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? Yeah, 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 three 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 twelve 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's mentioned, the seven 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. Julianne, let's go to the next question, please. Evan, our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open. Great. Thanks for taking my questions. 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 the 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. Thank you. 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 kick 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 studies, the HORIZON study, delivered the anticipated safety, and infections were balanced between placebo and treatment. All right, Julianne, next question, please. Thank you, Terence. Our next question comes from Gary Nachman from Raymond James. Please go ahead, your line is open. Hey, everyone, this is Tejas on for Gary. Thanks for putting on this call, guys, on all the data. So we were just wondering if you could talk about the filing strategies for Uplizna in both IgG4 disease and myasthenia gravis, and the timing of when you'll 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? Thanks. 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 these myasthenia gravis data, we expect to prepare regulatory submissions as well. Vikram? Yeah, 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 people already talked about for IgG4 previously, as well as the data today from for MG, these 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, our plan is to fully resource these two 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 two indications on Uplizna. All right, Julianne, let's go to the next question, please. Tejas, our next question comes from Kripa Devarakonda from Truist Securities. Please go ahead, your line is open. Hey, guys. Thank you so much for taking my question, and congrats on the progress. I know we'll see the detailed data from Uplizna later, but just wondering how important 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? Thank you. Yeah. So, thank you for both those questions. I think that there are several elements that are important when you think about the efficacy of a medicine, especially for MG patients. It's 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 that being equally important. Great. I think, Julianne, as we're getting close to the top of the half hour here, maybe we'll take two more questions. Thank you, Kripa. Our next question comes from Charlie Yang from Bank of America. Please go ahead. Your line is open. Great. Thanks for taking the question, and congrats on the data. There's 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 is, do you expect something that we can see similar to rituximab in the MuSK population, where some patient can, you know, potentially stop the treatment after a couple of doses and have, you know, three to five years of response? Thank you. 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 one-to-one randomization, goes out to a full 52 weeks. And so we'll learn more about durability through that window of time, especially after dose three is given at day 183. And then after the randomized control period, we have a pre-planned open label period with Q6 month dosing, from which we'll get, you know, some ongoing durability data, as well as a longer safety follow-up. So please ask the question again in 26 weeks. And hopefully, I have more data to share with you. But I don't mean to make light. It turns out to be really important for 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, which is 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 subset 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. All right, Julianne, we'll take our last question, please. Certainly. Thank you, Charlie. Our last question will come from Brian Skorney from Baird. Please go ahead. Your line is open. Hi. Thanks for taking our question. 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? And, you know, with patients achieving that, are you, what kind of effect are you seeing with the taper? Thank you. Yeah. 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 pre-planned taper of steroids from week four to week twenty-four. And we have not cut those data for consideration here today, but we, too, are very 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 appreciate your interest in our programs and Amgen. This concludes our Amgen conference call to discuss new top-line data in inflammation and rare disease. You may now disconnect.