Good afternoon, everyone, and welcome to our first quarter of 2026 earnings. We'll leave the call today and be followed by a broader review of our performance by Myrtle Gordon, Jay Bradner, and Peter Griffith. In the discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. Looking statements, which are qualified by our safe harbor statement, actual results can vary materially. Over to you, Bob.
Okay, good afternoon, and thank you for joining us. We had a strong first quarter and are well positioned to achieve our objectives for the year. Recall we previously described 2026 as a springboard year for Amgen, a year in which we expect our rapidly growing products to offset the financial impact of patent expirations and increase competition, while our next generation of molecules progress through the R&D pipeline, setting the stage for sustained long-term growth. As you can see from our progress thus far, we're on track to achieve these objectives. With steady execution through the rest of the year, we expect, once again, to demonstrate that we can grow through a period of patent expiration and deliver attractive performance for our shareholders with a strong portfolio of innovative medicines and biosimilars that meet the needs of patients with serious diseases. Listen to Murdo's presentation in a moment. Note the momentum of our six key growth drivers. Together, they generated 70% of our sales in the quarter and grew in aggregate by 24%. That strong performance sets us up well for the year and well beyond. Turning to the pipeline, our focus this year is on disciplined data generation and execution across a number of important Phase III programs, which, again, we expect will drive attractive long-term growth for Amgen. Our confidence in Meritide as a differentiated treatment for obesity, type 2 diabetes, and obesity-related conditions continues to build. We're executing effectively across the company, building the capabilities we need to bring this medicine to market. As Jay will discuss in a moment, we're disclosing additional phase 3 studies of Meritide, one of which will evaluate switching from the weekly injectables to Maritide on an every 8 or 12-week schedule. In other words, we'll evaluate switching from medicines which are injected 52 times a year to one which can be injected as few as 4 or 6 times a year. In addition, we'll evaluate weight maintenance for Maritide on a schedule of 4 or 6 injections a year as well. We expect there'll be a great deal of interest in these data. Beyond Maritide, we see strong potential across a number of other programs in late-stage development, including OpazRand and other innovative programs in Phase 3. We've talked about the excitement we feel about the convergence of technology and biology, including the application of artificial intelligence across the company. Here, too, we're making great progress. And there's no question we're in a period of tremendous change, and we're encouraged by the progress we're making in embedding new capabilities across the company. And we took steps early on to have Dave Reese lead these efforts, and we're grateful to him for the success he's achieved with this initiative. And we're encouraged that Jay Bradner will build on Dave's accomplishments, leading our artificial intelligence and data activities across the company. I'll have more to say about Dave at the end of the call. But before we turn to Murdo, let me just thank my Amgen colleagues around the world for their dedication to our mission to serve patients and the quality of their work again this year.
Thanks, Bob. As mentioned in the first quarter of 2026, 16 products achieved double-digit or better sales growth, and 17 products are now annualizing at sales of a billion dollars or more. Overall, we delivered 4% growth in product sales driven by a diversified portfolio that continues to outpace the impact of losses of exclusivity. Our business is now well underway with our six key growth drivers, which include Repatha, Avenidae, and Tespire, three innovative medicines delivering significant clinical benefit for large populations of undertreated patients, rare disease, innovative oncology, and biosimilars portfolios. These growth drivers delivered 24% year-over-year sales growth and generated $5.6 billion in sales in the first quarter, representing almost 70%. Starting with general medicine, Repatha delivered $876 million in first quarter sales, up 34% year-over-year. by increased urgency to treat patients in both secondary prevention and high-risk primary prevention, where intensive LDL-C lowering with Repatha significantly reduces major cardiovascular events. This is the epidemia guidelines now reinforcing earlier risk identification, lower LDL-C level and targets, and earlier uses of therapy like Repatha. These guidelines do not yet reflect the practice-changing Baselius-CV data, leaving a clear opportunity to further evolve clinical guidelines and quality measures. We expect these additional changes will further encourage cardiologists and primary care physicians to manage LDL-C levels below 50 milligrams per deciliter modification and secondary prevention, primary care, of high-risk primary prevention patients with diabetes. At the recent ACC meeting, the Vesalia-CV subgroup analyses in patients with diabetes and without non-significant atherosclerosis was presented and simultaneously published in JAMA. These data further reinforced the consistent and significant benefit of Repatha, delivering a 31% reduction in cardiovascular events. A trend in lowering mortality rates was also observed. The body of evidence is now very clear. treating patients earlier with Repatha, further strengthening access to Repatha by offering a simplified cash pay option to patients, which now also includes Enbro, Lotesla, Imovig, and Amgevita. Repatha is now the only PCSK9 inhibitor with positive outcomes data in both high-risk primary and secondary prevention patients. These data, along with Repatha's broad access, create an imperative to close the treatment gap for PAPHA, can help reduce heart attacks and strokes, and potentially save lives. Increased 27% in the first quarter to $562 million. U.S. sales grew 35% year-on-year, and Avenity maintains leadership of the U.S. bond builder market with a 65% market share. To date, approximately 320,000 U.S. patients have been treated with Avenity, supported by increased investment and an expanded field force. However, the unmet need remains significant, with more than 90% of the 2 million women at very high fracture risk remaining untreated, presenting a clear opportunity to expand the market and drive additional Avenity growth and impact. In Japan, Avenity has been prescribed to more than 900,000 patients since launch, and it leads the bone builder category with over 55% market share. We see a positive reaction to the treatment guideline updates by the Japan Osteoporosis Society, which further improves eventity's positioning and potential. Moving to inflammation, test buyer sales grew 20% year-over-year, reaching $343 million in the first quarter, driven by robust patient demand and solid execution across both pulmonology and allergy specialties. TESPIRE remains well-positioned to reach more patients in the U.S. given its differentiated TSLP mechanism that targets multiple inflammatory pathways driving severe uncontrolled asthma, including in those patients with coexisting chronic rhinosinositis with nasal polyps. This new indication is gaining traction and helping expand TESPIRE's reach across the U.S. combined delivered $1.1 billion in sales in the first quarter, a decrease of 32% year-over-year. Erosion, since loss of exclusivity, remains in line with our expectations, and we anticipate accelerated sales erosion over the remainder of 2026, driven by increased competition for multiple biosimilars. Our rare disease portfolio grew 25% year-over-year to $1.2 billion. Uplizna sales increased 188% year-over-year to $262 million in the first quarter, reflecting growing demand across all three approved indications. By the pace of growth and the potential that Uplizna has to help patients living with rare autoimmune conditions, he has been strong across both bio-naive and switch, requiring a step through another approved biologic. Given this momentum, we see a meaningful opportunity for APLISNA to become the first line and first switch, and increase APLISNA continues to maintain its leadership million dollars in the first quarter, up 32% year-over-year, driven by strong volume growth. Since its launch in 2021, we've combined efforts of our commercial, medical, and access teams to remove operational barriers that physicians encounter in practice. We've seen access to treatment in second-line small cell lung cancer, an aggressive disease with poor survival outcomes to extend. The court's in the court are increasing 12% year-over-year, driven by broad prescribing across both academic and community settings. recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome-negative B-cell. Our biosimilar portfolio delivered 14% year-over-year growth, generating $835 million in sales in the first quarter. Pat Blue, our biosimilar to ILEA, delivered $280 million in first quarter sales. Adoption continues to expand among retina specialists who appreciate PadBlue's ready-to-use, pre-filled syringe and Amgen's track record of manufacturing biologics and delivering reliable supply. Since our first product approvals in 2018, our biosimilars have generated more than $14 billion in cumulative sales, contributing meaningful growth while expanding patient access to high-quality, lower-cost biologics. Our first quarter results reflect both the strength of our key growth drivers and the commitment of our commercial, medical, and policy colleagues globally to improving the lives of patients facing serious diseases. And we remain focused on extending the reach of our medicines to even more patients in 2026. And now I'll hand it over to Jay.
Good afternoon, everyone. Let me begin with Meritide, a new paradigm in the management of obesity, obesity-related conditions and type 2 diabetes. The unique antibody peptide conjugate design of Meritide delivers a potential for strong efficacy with monthly or less frequent dosing and favorable tolerability to improve long-term treatment. Obesity medicines remain barriers to long-term persistence on therapy. For individuals with chronic conditions, sustained treatment is often required to realize the full health benefit of therapy. Maritide's unique properties, particularly its potential for monthly or less frequent dosing, may help reduce treatment burden and improve persistence on treatment over time. With this objective, we are excited to announce two new Phase III studies that focus on longer-term maintenance therapy with Maritide. We have initiated two long-term extensions of our ongoing Phase III chronic weight management studies to evaluate Meritide maintenance for durable weight loss. Two completed 72 weeks of treatment in the parent trial will enter a 48-week extension treatment period where they will receive a monthly clinical trials of studied Meritide in the initial management of obesity and overweight. We recognize that many patients may wish to switch to Meritide from weekly injectables. Today, we announced the initiation of another new Phase III study that will evaluate switching from weekly injectable GLP-1 therapies to Maritide, following dose escalation to a convenient every eight-week or quarterly dosing schedule. Combined with our ongoing pivotal chronic weight management phase three trials, the Maritide program will inform physicians on how to start a new patient on Maritide and frequent dosing. Describe the benefit of dose escalation for improving initial tolerability with Maritide. We observed marked improvements in GI symptoms progressing from one-step to two-step dose escalation. Our accumulating experience with three-step dose escalation is quite positive. For example, we recently completed one of our standard Phase I physiology studies in preparation for potential regulatory filings that utilized three-step dose escalation. As anticipated, three-step dose escalation further decreased the rates of nausea and vomiting as compared to prior experience, pre-step dose escalation and less frequent dosing are effective and well tolerated because of the unique antibody backbone of Meritide. Stability of an antibody creates a gentle and smooth stepwise increase in sustained drug exposure. Stable drug levels avoid the frequent peaks and troughs of daily orals and weekly injectables that may contribute to intolerability. We are confident and excited by Meritide and are focused on delivering high-quality clinical data to support future regulatory filings. Strong physician and patient interest in Meritide. Meritide is emerging as a new paradigm for patients with obesity, diabetes, and related conditions as a well-tolerated, first monthly or less frequently administered medicine. From one major public health challenge to another, we continue to build on the landmark findings from Merpatha in the prevention of cardiovascular events. In March, a new pre-specified subgroup analysis from the Phase III Visalia-CV trial was presented at the American College of Cardiology and simultaneously published in the Journal of the American Medical Association. A subset of high-risk patients with diabetes and without known significant atherosclerosis, Repatha demonstrated a significant 31% reduction in major adverse cardiovascular events, including heart attack. Repatha also demonstrated a nominal 32% reduction in the risk of cardiovascular death and a nominal 24% reduction in all-cause death. Together with the Vesalius CV data presented last fall, these findings reinforce the breadth and magnitude of benefit from Repatha in the primary prevention of cardiovascular disease. We forward to sharing additional insights and analyses from Vesalius with the scientific community, notably at the upcoming American Diabetes Association annual meeting. interfering RNA medicine that delivers greater than 95% reduction in LP little A with a quarterly dosing schedule continues to progress in phase three clinical investigation for secondary prevention of recently initiated the OCEAN-A CCTA study that evaluates the effect of OPCRAN on the burden of non-calcified plaque in coronary arteries as measured by coronary CT angiography. LP little A in medical practice is rising, reflected by the recently updated ACC AHA lipid guidelines that now recommend broader LP little A testing to build strong momentum across our portfolio. For APLISNA, we recently received European Commission approval for generalized myasthenia gravis. Rationale, we expect to initiate two pivotal phase 3 studies of APLISNA in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy by the second half of this year. We are also advancing to PEZA, where we recently reported positive Phase III top-line data for subcutaneous administration via an on-body injector. These data demonstrated robust efficacy in patients with thyroid eye disease for venous administration alongside a favorable safety profile. Subcutaneous administration of PEZA represents an important step forward in improving convenience and expanding treatment options for patients with thyroid eye disease. Dezodolivep, our first-in-class CD40 ligand-targeting fusion protein, continues to progress with two Phase III studies in Sjogren's disease now fully enrolled. These studies address both systemic and symptomatic disease, and both are expected to complete. Lately disclosed, the FDA proposed to withdraw the approval of Tavniose. We continue to believe that Tavniose is an important medicine for patients with ANCA-associated vasculitis, a rare and life-threatening disease with limited treatment options in the benefit-risk profile of this medicine, and expect to engage further with the FDA on this topic. To oncology, our bispecific T-cell engager or BITE platform continues to deliver meaningful impact for patients with advanced cancer. Indeltra is emerging as a standard of care in second-line, extensive-stage, small cell lung cancer, delivering an unprecedented survival benefit in a disease that has seen very little innovation for decades of therapy, we are encouraged by the apparent improvement in median overall survival in the first-line maintenance setting to 25.3 months, observed in the Phase 1B Delphi-303 study. Frontline maintenance within Deltra is now being evaluated in the ongoing Phase 3 Delphi-305 study. Xelaritamig, our first-in-class STEEP-1-targeting bispecific T-cell engager, is advancing rapidly with two ongoing Phase III studies in metastatic prostate cancer. Multiple ongoing Phase I-B studies are underway, where we've taken a deliberate and differentiated approach toward earlier stages of disease to maximize long-term patient benefit. When patients experience a rising PSA without clinically evident disease, we are evaluating Xaloritomig as monotherapy without androgen deprivation therapy, advancing into metastatic hormone-sensitive prostate cancer, where we are evaluating Xaloritomig on top of standard of care hormonal of developing a more effective regimen without chemotherapy. A note about our oncology portfolio. In intensive review, we've taken the decision to discontinue development of AMG193, our MTA cooperative PRMT5 inhibitor. Amidst the rapid advances in artificial intelligence, we've taken a principled approach to reconsidering and augmenting drug discovery and therapeutic development. At the intersection of powerful AI models developed both externally and internally with Amgen research and insight-rich proprietary data sets, we are beginning to see meaningful, tangible advances across Amgen R&D. Integrated multi-omics data resources at Amgen Decode Genetics identify new targets, in particular within non-coding regions of the human genome studied at population scale. Antibody lead optimization has accelerated by 50% from contributions both to lead discovery and lead optimization. In clinical development, we have designed and implemented a proprietary site selection model that improves clinical trial enrollment with a significant, and in some cases, up to three-fold improvement in enrollment rates. Leveraging large language models and agentic AI for regulatory filing preparation, we are seeing early promising results in data ingestion, integration, and document drafting. These are early innings, but we are captivated by the potential for AI and data science to deliver measurable impact and value in R&D and across the enterprise, as Peter will highlight in a few moments. One of our revered and beloved colleague, David Reese, I'm excited to lead the AI and data transformation across our business at the enterprise level, working in partnership with our leadership, saying that we are encouraged by the progress we've made in the first quarter with a continued focus on disciplined data generation across the portfolio. With a robust pipeline and meaningful breadth and depth across four therapeutic areas, we are well positioned to deliver continued innovation for patients with long, sustained value. I want to thank my colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases.
I'll now turn it over to Peter for the financial update. ...performance, executing through a full quarter of the patent expirations and losses of exclusive 5%. We continue to invest in advancing our pipeline with non-GAAP R&D spending increasing 16% year-over-year in the first quarter. This reflects increased spending on our late-stage pipeline, including continued investments in Meritide, Imdeltra, and Opacorant. Cost of sales is a percentage of product sales with 19.5%, driven by higher profit share and royalty expenses. It's across our U.S. manufacturer capacity for Vaughn Intelligence and operate with greater speed, productivity, and colleagues across Amgen turn capital to shareholders through competitive dividend payments of $2.52 per share, representing a 6% of 25%. Look for the business for the remainder of 2026. As we said last quarter, we expect 2026 to be a springboard year for future growth. Our strong first-quarter performance reinforces that outlook, and we're raising our 2026 guidance ranges for both revenue and non-gap earnings per share. We expect 2026 total revenues in the range of $37.1 billion to 30 to be between $21.70 and $23.10. sense. These ranges reflect our confidence that the emerging growth drivers will more than offset the outgoing legacy brands. Note, our guidance does not include any potential business development transactions that may occur throughout the remainder of the year. Let me highlight a few updates to our outlook for the remainder of the year. The revenue to be in the range of $1.7 to $1.8 billion. We now anticipate non-GAAP OINE to be in the range of $2.2 to $2.3 billion of expense. We now expect a non-GAAP tax rate in the range of 15.0% to 16.5%. And let me remind you of prior items that have not changed. We continue to expect the full-year non-GAAP operating margin fails to be roughly 45 to 46 percent. This reflects our commitment to investing in the best innovation as we continue to rapidly advance the Maritide Phase III program and additional key late-stage assets to exceed $3 billion. In regard to our ongoing tax litigation, the tax court litigation covering tax years 2010 through 2015 remains ongoing, And while we expect a decision no earlier than the second half of 2026, we remain confident in the case we presented at trial. We are currently under audit by the IRS for the 2016 to 2018 tax years. In April 2026, we received a draft notice of proposed adjustment, or NOPA, from the IRS for 2016 to 2018, asserting significant adjustments primarily related to the allocation of profits between the United States and Puerto Rico. The approach taken by the IRS is similar in nature to our 2010 to 2015 dispute with the IRS currently pending in tax court. If sustained in full, the adjustments set forth in the draft NOPA could have. We disagree with the draft NOPA and have informed the IRS audit team that its draft calculation methodology is inconsistent with the positions asserted by the IRS in the tax court, which positions were more favorable to Amgen than the draft calculation methodology taken by the IRS that the IRS positions are without merit, tax reserves are intended to continue to vigorously defend our position, just as we have throughout our entire dispute, long-term growth and creating value for patients that we said we would do, executing on our growth drivers, advancing innovation in areas of high unmet medical need, and maintaining rigorous financial discipline, and our mission to serve patients. This concludes our financial update for Q&A.
Julianne, why don't we open up the lines for questions? I know it's been a long day for many of our callers, so let's jump straight in and try to get to everybody. There's as many questions as we can. We'll try to limit you to one question each, please, but let's get started, Julianne.
Operator
Thank you. If you'd 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, please press star followed by 1. Again, to ask a question, press star 1. Our first question comes from Geroen Werber from TD Cowan. Please go ahead. Your line is open.
Speaker 15
Great. Thanks so much. Maybe, Jay, unsurprisingly, first question on the Meritite switch studies. Can you give us a little bit of a sense? Are you switching sort of one-to-one-to-one, two-monthly, every two months and every three months? And are you looking at superiority or non-inferiority and sort of what's a non-inferiority sort of margin?
Yeah, Jeroen, thank you for the interest. As I just shared, you know, people are naturally very interested to know what will it take to switch from a weekly injectable to a medicine potentially quite a bit more convenient and quite active. And so the switch study is designed to provide that experience. There will be 300 subjects on study with obesity or overweight. There will be a run-in on weekly demaglutide or tizepatide, and then they'll switch to maritide, as I said, every eight-week or quarterly basis. And the primary endpoint of this trial will be a change from baseline body weight after 52 weeks of maritide treatment. We look forward to these results.
Operator
Thank you, Yaron. Our next question comes from Selvene Richter from Goldman Sachs. Please go ahead. Your line is open.
Good afternoon. Thanks for taking my question. Could you just comment on the Meritide switching study and why it only evaluates the every two-month and three-month and not every one month? And then as you think about the profile today, how significant do you expect the maintenance opportunity to be for Meritide? Thank you.
Thanks. Why don't I start with the question around the design of the switch study, MIRDO, and then you can talk about the opportunity thereafter. after, we have a lot of experience with monthly Meritide in this program, which is featured in, to date, all of the enrolling of Phase III programs, and we've had a really good experience in the maintenance setting in our Phase II, Part II. In that regard, the long-term extensions that we've just described, where we switch from Meritide to Meritide, give us a chance to explore less frequent dosing after effective dosing and comparably in this switch study, we're focusing that trial on the learnings of going from weekly to an every eight-week and every 12-week treatment regimen, which can make Meritide quite attractive to patients.
Yeah, thanks, Jay, and thanks, Salveen. Obviously, the goal here for weight loss is to lose weight and then sustain it over multiple years so that you can get the full medical benefit of the treatment. And given that we are coming later into this market and there will be many, many patients already on other weekly treatments, we thought it would be helpful to prescribers, to clinicians and patients to understand how to convert, how to switch from those weekly agents to, as Jay mentioned, a more convenient regimen. And it'll also be necessary to describe, once you reach your weight loss goal on monthly Maritide, how you would want to opportunity, given the timing of our launch and order of entry, then they may be dissatisfied with it.
Okay, let's go to the next question.
Operator
Our next question comes from Luca Issi from RBC Capital Markets. Please go ahead. Your line is open.
Hey, Jane. Thanks so much for taking our question. This is Cassiano for Luca. So we have a question for Indultra. The drug has clearly done very well so far in a second-line setting. Can you tell us more about what's next for Indultra, not only in terms of the opportunity you get once you move to the front or lines, but also now with Indultra selected as part of the real-time clinical trial pilot program? Could you help us understand the process? The idea, basically, FDA will look at your data scientist together as the study is going and for indications with no healthy volunteers. You essentially can go straight from first-in-human to approval without pausing for safety or end-of-phase reviews. And I'm curious what made FDA pick Indeltra as the pilot program. Thanks so much.
Well, let me please start, Luca. Thank you for the question. Indeltra has really emerged as the standard of care for patients with second-line small cell lung cancer because, as I mentioned moments ago, the unprecedented efficacy afforded by M-Deltra on just the most important endpoint, overall survival. As for so many medicines in advanced cancer, medicines that work in later stages of the disease tend to confer even more clinical benefit when they've moved to earlier lines of therapy and earlier stages of lower disease burden, especially when they're used in combination. And so we are advancing M-Deltra quite actively and aggressively into frontline induction as well as frontline induction and maintenance. The maintenance experience with M-Deltra and the frontline experience will be in extensive stage, small cell lung cancer, and these studies are rapidly progressing. Further, we have the Delphi-306 study, which studies terlatumab versus placebo after chemotherapy and radiation in frontline limited-stage small-cell lung cancer. We're so hopeful for these trials and just cannot wait to read them out. As you've described, we have had a chance to collaborate with Commissioner McCary and members of the FDA on imagining what a clinical study might look like in the real-world prospective practice. And we have a very fine design coming together with the FDA that will give us a chance to characterize IMDELTRA in a clinical trial setting, but in the real world, leveraging things like electronic health records and real-time data capture, as opposed to the way the clinical trials are conducted today. And this could be a very important experiment for us and for others. Trials initiated don't complete. Enrollment is very challenging. managing data and packaging it and then submitting it to regulators is quite a big book of work. And if there's a way to do this in more real time.
The other thing that I would add here is we've a nice randomized clinical program reading out through the balance of this year into next to further expand the use of this product. And Delta seems to have very durable survival, as we've seen in our phase one data. And, importantly, in these innovative trial designs that the FDA is in discussion on, primarily those in community settings in regional hospitals or in community oncology practices, better care for their patients closer to their homes, which is a really exciting opportunity.
All right. Let's move on.
Operator
Our next question comes from Michael Yee from UBS. Please go ahead. Your line is open.
Thank you. Great. Maybe a question on olipasterin. Obviously, you guys have a well-designed study and a potentially superior drug. I'm wondering if you think that background therapies such as GLP-1 or PCSK-9 either would impact your trial design or your competitor trial design and how you think about that impacting the overall results of what we might see from a competitor.
I didn't want you to answer that. Yeah, thank you for the question, and we see it the same way. The OCEAN-A study is a very well-designed study, a randomized controlled trial of almost 7,300 patients with LP little A's over 200, and a medicinal pass ran with best-in-class performance characteristics, as you cite, 95% reduction in LP little A with every 12-week dosing. So we're really looking forward to reading out this event-driven trial. We have built this study around a very high-risk group of patients. Elevations in LP little A are genetically defined, and as such, one in five individuals will have elevated LP little A. And unfortunately, to your question, you can't take a GLP-1 medicine or a statin or even Repatha and meaningfully reduce levels of LP little A. This independent risk factor maps to a very atherogenic and inflammatory characteristic of the LPA molecular disease, and we contribute to that with Repatha. We're very confident in this study as defined.
Operator
Our next question comes from Taryn Flynn from Morgan Stanley. Please go ahead. Your line is open.
Great. Thanks for taking the question. Bob, I was just wondering, we've seen a pretty active M&A year thus far in the sector. just as you think about Amgen's needs, you know, potential size of opportunity. How are you thinking about the BD and M&A landscape right now, given, you know, your current needs, but also your strength, your balance sheet?
Yeah, I think, Terrence, I'm not sure I'd use the word needs the way you have in your question, but we're very active in business development, as we always have been, looking for innovation that we think we can add value to. So that remains the case. I think the areas where we're interested are very clear to you and to our investors, and we'll continue to see if there are things that, again, that line up in a way that we can take over programs and still add value to our shareholders.
Operator
Our next question comes from Jeff Meacham from Citi. Please go ahead. Your line is open.
Thanks for the question, guys. Murdo, Repatha has been consistently strong, but I want to get some perspectives from you on penetration into primary prevention, and where could it go? And as you look to the El Pastorin data, how do you think primary prevention looks as a key market within the LP little egg segment?
Thanks for the question, Jeff. We're really excited about what's happening in primary care. As you'll recall, we expanded the promotion and coverage of our primary care sales team at the beginning of last year. We expanded our medical teams in anticipation, of course, of some of the news flow that we've seen from new data from the Vesalius CV trial that we presented last November at the AHA meeting. And then, as Jay mentioned, the subsequent sub-study in diabetes patients without atherosclerosing, significant benefit with a 31% reduction in three-point MACE and a 31% reduction in four-point MACE. So we have a clear opportunity to help these patients who are in the care of the primary care physician. You know, the average diabetes patient without documented atherosclerosis is someone who's not being referred to a cardiologist. And so since the change in our label, which occurred actually just prior to the Vesalius trial being presented, we've been out there talking to primary care physicians. We've seen really, really good uptake. In the quarter, we had a global league. But if you look at new to brand prescription evolution in the U.S., we were up 44% in the quarter and that's being driven by increased depth of prescribing by cardiologists. The momentum to disease be the genetically determined level so you really only need to do that the test once it's affordable, it's accessible and so that that bodes well for having some population of patients who will know their LP level and I do think that primary care physicians will play treating those patients levels with hopefully a product like Opasser and should the data bear out. Okay, good. Let's move on to the next question.
Operator
Our next question comes from David Reisinger from Leerink Partners. Please go ahead. Your line is open.
Thanks very much. So my question is for Murdo, please. So congrats on the launch of Amgen Now. I think that occurred last fall. Could you provide some quantification on the uptake of Repatha by cash pay patients? And I don't know if it's meaningful enough yet, but possibly the current mix of sales between cash pay and covered given the strong ramp of Amgen now. And then is Amgen considering leaning into to offering Repatha as a cash-paid product, ex-US? Thanks so much.
Thanks for the question, David. We've been pleased with the overall response to the Amgen Now offering. As you'll recall, Repatha is offered at a $239 a month price point, and we are seeing cash-paying patients interested in pursuing Repatha. Now, at the same time, however, it's important to note we've opened up access substantially for Repatha, and so many patients now can access Repatha without much friction, and their physician can simply attest that the patient meets the criteria for the indication of the product. So I wouldn't expect the cash-paying component of patients going through Amgen Now to be substantial. We are in the kind of the 8,000, 9,000 patient range of patients moving through the Amgen Now program, and we continue to see more and more interest there. So it's been a success, but as a percentage of total Repatha, as you'll note, it's relatively small.
Operator
Our next question comes from Matt Phipps from William Blair. Please go ahead. Your line is open.
Hi, thanks for taking my questions. I was wondering on some of the Blenatumab updates. First off, you noted in the press release that enrollment is stopped in the SLE trial. Can you use any updates on that status? And it also looks like you're pausing enrollment of the sub-Q administration and ALL. Any additional reasoning for that pause? Thank you.
Sure. Thanks, Matt. I'm happy to take the question. Blenatumab is proving to be an important component of standard of care for adults and children with relastin refractory B-cell human floblastic leukemia, and its current instantiation is delivered by intravenous continuous infusion. We have studied and characterized subcutaneously administered blinitumumab in the past, and there is a chance with this medicine for even higher remission rates, As we have previously shown at a BHA presentation, we observed 89, 92 percent remission rates with manageable safety in adults with relapsed and refractory BALL. And so we're very encouraged by the efficacy team with subcutaneous blend and our moving subcutaneous blend to earlier lines as you shared, that's where a side effect. The actions were, at this moment, collecting some patient data and having a dialogue with the FDA. We expect to be able to open these studies back for enrollment shortly.
Operator
Our next question comes from Chris Schott from JPMorgan. Please go ahead. Your line is open.
Thanks so much for the question. I just want to come back to Meritide. It sounds like some encouraging earlier stage. Do you provide any more color on what levels of vomiting and duration?
Chris, thanks. The level of nausea and vomiting observed with 3-step dose escalation is lower than we've seen before. Dose escalation works for GLP-1 agonism-based therapy. That is known. In our experience, one step improved GI tolerability significantly. Two-step improved it further. And today we share the unsurprising but accumulating data that provide clinical confirmation that three-step dose escalation further improves GI tolerability. Now we await efficacy and tolerability data from the ongoing Phase III studies, but we're quite encouraged by what we've seen.
But Jay, on the question of duration, you may help him understand what we see, help Chris understand what we see and how it's different from what we're observing from the weekly and dailies in terms of the side effect duration. Side effect profile, yes.
You know, before we started this research, we didn't know would a long-acting medicine like Meritide that can be delivered monthly or every eight weeks or every 12 weeks enjoy durable efficacy owing to high time on target. this antibody backbone leads to very smooth and stable exposure over a long period of time, engaging GLP-1 receptors and GIP receptors in the brain and peripheral tissues. Would that durable efficacy be associated, when there was a side effect, with a long-term side effect, and that we don't see? When we do observe nausea and vomiting, it tends to be quite short in its duration over the course of one or several days, no different than the weekly GLP-1s, but different than the weekly GLP-1s and different than oral GLP-1s that are short half-life medicines that's trot to peak spots in the GI and otherwise.
We have time for two more questions.
Operator
Thank you. Our next question comes from Akash Tawari from Jefferies. Please go ahead. Your line is open.
Speaker 4
Hey, thanks so much. Josh, for DAZO's Phase II Sjogren's programs, you're making an interesting bet splitting it up into systemic and symptomatic patients. What kind of drove that decision, and which one of those trials are you more confident will work? And can you go over any of the biological difference between DAZO and then the Novartis CD40, but also Sanofi CD40L, which both ended up discontinuing the programs?
Yeah, Josh, I love your questions, because they invite a mechanistic characterization of these molecules, but I'll try to keep this brief, though it will be hard for me. We observed in phase two very strong activity of dasodolibib, which, as you comment, is a CD40 ligand FC fusion protein, targeting fusion protein. And the performance against the S-Di score in Sjogren's syndrome is quite a unique situation. It has proven very hard to develop effective medicines in Sjogren's disease. But seeing movement in the S-Dye score, that made us very motivated to follow this up in phase three clinical investigation. The presentation of this heterogeneous disease can be quite different clinically. And so we thought to segregate, in order to have clear clinical outcomes in these clinical trials, into two phase three studies, patients with what we'll call systemic disease, but then also very sick, a separate study of moderate to high symptomatic disease, but there with low systemic disease activity in the case that these two populations might be considered differently to observe meaningful differences attributable to those biological, those clinical presentations. These studies have completed enrollment, and completion of both studies is expected in the second half of this year. Deso-Dalibep is a product of a long-sought-after drug discovery campaign, honestly, in the field of immunology. CD40, CD40 ligand signaling is fundamental to T-cell, B-cell co-stimulation, CD40 ligands on T-cells, CD40s on many, many different kinds of cells, and that makes this molecule very different than CFC-533 disease, whether or not it's symptomatic. is that T and B cell activation is the primary driver. This isn't a dry gland disease. It's enriched with inflammatory cells. And so we believe that CD40 ligand is the right lever to press on as it will impact all downstream signaling by targeting the upstream CD40 ligand. Reading out these studies, one with the S-Guy score, another with the DOSPRI score, appropriate for a symptomatic study.
I'll take one last question, and then I'll have a couple remarks, and we'll be finished.
Operator
Thank you. Our last question today will come from Louise Chen from Scotiabank. Please go ahead. Your line is open.
Thanks for taking my question. I just wanted to ask you, if you get Meritide approved, what are you playing for here? Do you want to be the number three player behind Nova and Lilly, or are you sitting in a higher position than that with your product?
That's a tempting question to consider a softball pitch over the middle of the plate here at the end of the day. But, Myrtle, do you want to offer any quick thoughts for Louise, and then we'll wrap up?
Well, I think we're going to be the best monthly or less frequently prescribed agent, Louise. But, no, in all sincerity, this is a highly differentiated product. I think the opportunity is substantial to come into a market with something that really is a new paradigm-changing opportunity for a massive category. And our focus is going to be on helping as many patients as possible in that category, whether they are de novo patients who have yet to attempt a weight loss treatment and they'll be new to Maritide, or whether they're on another therapy and they're not achieving the results they like or they're not enjoying the frequency of injections or they're having side effects and they want to try another treatment. And we will, across the business, across the company, we will be ready to go into that market and compete effectively with all of the other companies that are already there.
I know some of our competitors have risen to the bait of that question, Louise, but we'll resist and wait instead until we have the data in hand. And as you know, we're working diligently to try to generate the necessary data to register this molecule and, as Murda said, help as many patients as possible. There are very many who need differentiated therapy like this, and we're looking forward to having the data so that we can appropriately talk to them. But before we wrap up, I just wanted to, as I mentioned earlier in my remarks, I just wanted to take a moment and acknowledge that Dave Reese will be retiring from Amgen at the end of the second quarter, and I wanted to thank him publicly for his contributions to Amgen over the past 20 years. As a longstanding leader and former head of R&D, Dave's legacy here, as you all know, includes a generation of innovative medicines. What you may not be as familiar with is that Dave has been a persuasive champion for change and new technologies at Amgen And recognizing long ahead of many others the growing importance of AI and what he called the hinge moment, Dave both raised his hand to be Amgen's first chief technology officer and helped attract Jay Bradner to be his successor as head of R&D. So we're thrilled, excited about the progress that we made in artificial intelligence and data under Dave's leadership, as well as the other businesses that Dave has had responsibility for. And, again, we're grateful that Jay will build on what is a very solid foundation following Dave's retirement at the end of the second quarter. Dave is both a close colleague and friend to many of us, and we will all miss him and wish him well in what we're sure will be a very active retirement. So, Dave, on behalf of all of Amgen, thank you, and let me thank all of you for joining our call as well.