Amgen Inc.

Thank you, Julianne. Good afternoon and welcome to our first quarter 2024 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Jay Bradner, Myrtle Gordon, Vikram Karnani, and Peter Griffith. Through the course of our 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. We will also make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results can vary materially. Over to you, Bob.

Okay. Thank you, Justin, and thank you to our callers for joining us today. This is a busy and exciting time here at Amgen, and as you can see from our results, we're reaching many more patients around the world with our existing medicines, advancing a broad range of potential first-in-class medicines in our mid- and late-stage pipeline, and redefining what's possible in research as we integrate wet and dry lab capabilities and harness transformative technologies. I'll touch on a few highlights from the quarter that give me great confidence that we're on a path to deliver attractive long-term growth. First, we have a number of products across general medicine, oncology, and inflammation that have strong momentum and still plenty of room to grow. These include Repatha, which was up 33%, Avenity up 35%, Lincyto up 26%, and Tespire up 80%. With Lincyto, we expect an approval in June that should accelerate our efforts to integrate into earlier treatment lines for acute lymphoblastic leukemia. With Tespire, we'll share data later this month that reflect the attractive potential of this medicine in chronic obstructive pulmonary disease. COPD is the world's third leading cause of death. Clearly, new treatments are very much needed, and we're excited by Tespire's potential to make a difference there. Second, our newest pillar of growth, rare disease, contributed nearly a billion dollars of sales in the quarter, up 14% compared with the sales of these products from a year ago. We see significant upside potential for first-in-class early-in-life-cycle medicines like Tepeza, Christexa, Upuzna, and Tavneos, and we're pursuing launches in new geographic markets, new indications, and or new formulations for each. As an example, we announced last week our imminent plans to file Tepeza for approval in the European Union. Overall, the integration of Horizon, Its people, products, and pipeline is proceeding well, reflecting the strong fit between our organizations. Third, we're rapidly advancing a number of promising new medicines in our mid- and late-stage pipeline, spanning all four of our therapeutic areas. We are awaiting approval for tarlatumab, for example, and look forward to bringing this transformative innovation to patients with small-cell lung cancer. Tarlatimab is the first T-cell-engaging therapy to demonstrate significant clinical activity against a common solid tumor, a watershed moment in a field that Amgen pioneered and continues to lead. Looking to the rest of the year, we anticipate data readouts from five Phase III trials. In addition, we announced today the development of a biosimilar to Keytruda as we look to build upon the global leadership we've established in biosimilars. In sum, we have a broad range of medicines in hand today and coming through our pipeline that will enable us to meet the needs of millions of patients around the world and deliver strong growth through the end of the decade and beyond. Now, let me just add one other important update. Whereas we don't normally comment on interim data, especially for a Phase II trial, we recognize there's significant interest in obesity and Maritide, so we'll provide additional commentary today. The interim phase two analysis for this study is complete, and we are very encouraged with the results that we've seen thus far and with the conduct of the trial. Following the interim analysis, I would say we're confident in Meritide's differentiated profile and believe it will address important unmet medical needs. We are actively planning a broad phase three program, including obesity, obesity-related conditions, and diabetes. Obviously, we expect to carefully complete our ongoing phase two trial before then moving as swiftly as appropriate to establish the safety and efficacy of this potential medicine in phase three trials. We've initiated activities as well to further expand manufacturing capacity with both clinical and commercial supply in mind. Jay will provide a few additional remarks with respect to this ongoing study. I would ask you to recognize that to protect the integrity of the study beyond this update, We would not expect to discuss these data in further detail before completion. As always, I want to thank our employees around the world for their commitment to our business and to the patients we serve. Jay, we'll turn it over to you.

Thank you, Bob, and good afternoon, everyone. Let me start with Meritide. Reiterating Bob's comments, we are very pleased with the results seen with Meritide thus far, and we're very pleased with the overall conduct of the ongoing Phase II trial. All arms remain active, patient dropout has not been an issue, and we're fully on track for top-line 52-week data from this 11-arm Phase II study in late 2024. We're seeing a differentiated profile with Meritide and are confident that it will address important unmet medical needs in obesity, obesity-related conditions, and diabetes. We look forward to completing the ongoing Phase 2 study and working with regulators to move rapidly to the broad Phase 3 program. Later this year, we plan to initiate an additional dedicated Phase 2 trial investigating Meritide for the treatment of diabetes in patients with and without obesity. This new trial is not a gating step for our Phase 3 program in patients with obesity. Informed by dose and schedule insights from the ongoing Phase 2 obesity study, The dedicated Phase II study in diabetes conforms to regulatory requirements for Phase III and is the next step towards a diabetes indication for Meritide. In terms of patient experience, we expect to deliver Meritide in a convenient, handheld, patient-friendly auto-injector device with a monthly or even less frequent single-injection administration, assuming eventual approval. Across the portfolio, we are presently prioritizing differentiated medicine, those that stand to provide the greatest benefit for patients. Given the profile we've seen with AMG 786, we will not pursue further development. Instead, in obesity, we're differentially investing in Meritide and a number of preclinical assets. Beyond Meritide, in the first quarter, we rapidly advanced our diverse clinical pipeline of potentially first-in-class or best-in-class programs. Looking ahead, the remainder of 2024 promises to be an exciting time for research and development. with two PDUFA dates in June for tarlatanam in small cell lung cancer and Blinsito in adult acute lymphoblastic leukemia, as well as five Phase III data readouts. Each of these milestones could represent a significant advance towards our mission to deliver groundbreaking treatments to patients in real need. Moving to Olpasaran, we're pleased to announce that we've completed enrollment of the Ocean A Outcomes Trial, a Phase III cardiovascular outcomes study of Olpasaran, our potentially best-in-class LP little a targeting, small interfering RNA medicine. Reflecting both our commitment to patients suffering from cardiovascular disease and the strong interest of the medical community, we successfully enrolled 7,297 patients across the globe in just 15 and a half months. To our knowledge, this is the fastest enrolling phase three outcome study of its size. And to remind, LP little a is a genetically defined cardiovascular risk factor, which is elevated in approximately 20% of individuals, and for whom no effective or targeted therapies currently exist. In oncology, we continue to deliver on high-conviction targets with differentiated therapies capable of delivering a large effect size for patients. Starting with tarlatumab, a first-in-class bite molecule targeting DLL3 for small cell lung cancer, we remain on track with an FDA priority review for a June 12th PDUFA date. We're excited about tarlatumab. as potentially the first selective therapy for small cell lung cancer. Based on the remarkable activity observed as a single agent in patients receiving second- and third-line therapy, we are rapidly advancing tarlatumab into frontline treatment, with three Phase III studies now initiated in both extensive-stage and limited-stage disease. The rationale for studying tarlatumab in earlier lines of the context of lower tumor burden draws from our experience with Blinsito and B-cell ALL, There we saw a dramatic improvement in overall survival in minimal residual disease negative patients. These BLINCITO data provide evidence that directing the T cell in this manner is an effective means of finding and eliminating residual cancer cells, which are primarily the drivers of recurrent disease. We're hopeful we can build on this insight with Tarlatamab, where comparable activity in early stage small cell lung cancer patients would very meaningfully improve outcomes for patients facing the challenge of this aggressive cancer. In sum, We regard Tartlatumab as a major advance as the first bispecific T-cell engager to demonstrate efficacy in a common solid tumor, further establishing the broad potential of our bispecific T-cell engager platform. Our first-in-class STEEP1 CD3 bispecific molecule, Zaluridamig, has also demonstrated unambiguous activity in a solid tumor, namely prostate cancer. It continues to advance following a presentation of encouraging Phase I data last fall. We have now fully enrolled the monotherapy phase one dose expansion and continue to enroll patients in reduced monitoring and outpatient cohorts. Further, combination studies with Zaluridamig and novel hormonal therapies are progressing in dose escalation studies with near-term plans to initiate dose expansion cohorts. To round out oncology, we are rapidly advancing AMG193, our oral PRMT5 inhibitor targeting MTAP null solid tumors. we've moved forward with monotherapy dose expansion studies and have initiated two additional Phase I studies targeting mTAP null tumors in thoracic, gastrointestinal, biliary tract, and pancreatic cancers, exploring relevant combinations with standard of care. In our inflammation portfolio, we're encouraged by the results of the coarse Phase IIa proof-of-concept study, which investigated TESPIRE in patients with moderate to very severe COPD. This study was designed to test TSLP inhibition across an intentionally broad range of eosinophil levels, irrespective of inflammatory drivers, emphysema, chronic bronchitis, and smoking status. While test buyer achieved a clinically meaningful 17% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo, this result felt short of statistical significance likely owing to the broad overall patient demographic. However, even greater reductions in COPD exacerbations were observed in a planned subgroup of patients with baseline blood eosinophil counts greater than 150 cells per microliter, with a trend for further reduction in a small number of subjects with baseline counts greater than 300. We're excited by these data, which will be presented in an oral session of the American Thoracic Society annual meeting later this month. Together with our partner, AstraZeneca, we're actively planning for Phase III development of TESPIRE and COPD. Beyond COPD, we continue to explore test-buyer in separate Phase III studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected in the second half of this year. The Rocket Phase III program for rocatinlamab, a first-in-class anti-Ox40 monoclonal antibody, has successfully enrolled over 2,800 patients with moderate to severe atopic dermatitis. Indeed, Three of the eight studies in the Roca-Tinlamab Rocket Study Program are now fully enrolled. The Phase III Horizon Study, part of this rocket program, evaluates Roca-Tinlamab monotherapy versus placebo in adults with moderate to severe atopic dermatitis and remains on track for top-line data readout in the second half of this year. Beyond atopic dermatitis, we continue to broadly explore rocatinlamab and additional indications and have initiated a Phase II study in moderate to severe asthma with plans to initiate a Phase III study in prurigo nodularis in the second half of this year. We're encouraged by the advancements of our rare disease pipeline as well, with several mid- to late-stage opportunities, starting with aplizna, We anticipate important Phase III data readouts this year in myasthenia gravis and IgG4-related disease, both diseases with significant unmet need and where we have the potential to make a real difference for patients. Dezodolibep, an innovative CD40 ligand inhibitor fusion protein, has entered Phase III for Sjogren's disease, with two studies now enrolling patients. This follows encouraging Phase II data with efficacy across patients with moderate to severe systemic disease and patients with high symptom burden. Dazodolibap is the first therapy to demonstrate efficacy in the latter patient population. Lastly, in our biosimilars portfolio, we've initiated a Phase III study of ABP234, a biosimilar candidate to Keytruda, in subjects with advanced or metastatic non-squamous, non-small cell lung cancer. We're also pleased to announce that Wislana, our biosimilar candidate to Stelara, has received a positive CHMP opinion. In closing, I'd like to thank my Amgen colleagues. with a strong sense of service to patients facing serious illness and their commitment to growing the impact of both our research and our business to our portfolio of potential first-in-class and best-in-class medicines. And I'll now turn it over to Murdoch.