Amgen Inc Wells Fargo 21st Annual Healthcare Conference

Thank you, Mohit. It is really good to be here. Before we get into Q&A, I would like to take some time to introduce myself briefly and share a few thoughts on how we see the business today. As many of you know, it is actually my second chapter at Amgen. I spent nearly a decade here earlier in my career working very closely with Bob and with the team at Amgen. I have had the opportunity to serve in the meanwhile, while away, as the CFO of three public listed companies, where my responsibilities actually extended beyond finance into things like strategy, transformation, operations. I gained quite some experience in a more consumer-focused healthcare environment as well. I come back to Amgen knowing the company well, but at the same time, looking at it through fresh eyes, informed by my experiences over the last 12 years.

Given my recent background with a private equity-led IPO of a fast-growing company in a more consumer-focused healthcare setting, my focus will be on working together with my fabulous colleagues at Amgen as one team, driving execution and financial discipline to enable growth acceleration, both commercially and of the pipeline. I will focus on cash and cash returns, which is very consistent with Amgen's long-standing approach to capital allocation. On Q2, our second quarter results were driven by the breadth and depth of our portfolio. Once again, demonstrated our ability to grow through patent expirations and increased competition. Our six key growth drivers, Repatha, EVENITY, TEZSPIRE, rare disease, innovative oncology, and the biosimilar portfolios continued to deliver. Together, they grew 26% year-on-year and represented nearly 70% of total second quarter product sales.

Overall in the quarter, total revenues exceeded $10 billion, up 10% year-on-year, and 22 products delivered double-digit sales growth. These results, including strong margin and earnings performance, were achieved while increasing our investment in innovation, reflecting the sound financial structure that Amgen has as a business. Many of our medicines, and that is what is behind it here is, many of our medicines address large under-penetrated disease areas, giving us confidence that there are significant opportunities ahead of us to serve many more patients. We are adding new indications to some of our products like TEZSPIRE, UPLIZNA, and IMDELLTRA, while also broadening our geographic reach with these medicines and others. We have recently announced exciting phase III results from two of our approved medicines.

As you have seen earlier this week, we announced landmark phase III results from DeLLphi-305 evaluating IMDELLTRA in combination with durvalumab as first-line maintenance treatment in patients with extensive stage small cell lung cancer. The study demonstrated statistically significant and clinically meaningful improvements in overall survival, progression-free survival, and objective response rate compared with durvalumab alone. We view these data as important inflection point for IMDELLTRA. In the second-line setting, IMDELLTRA is becoming a standard of care supported by strong survival benefit, clinical differentiation, NCCN recommendations, and rapid adoption across sites of treatment. These landmark results from DeLLphi-305 suggest IMDELLTRA will further revolutionize the standard of survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease.

That's why we're advancing IMDELLTRA through a broad phase III program across first-line extensive stage and limited stage SCLC, while also pursuing more convenient administration. Together, these programs represent a combined addressable population of approximately 28,000 patients in the U.S. We believe IMDELLTRA has the potential to become a foundational medicine across the small cell lung cancer continuum and will continue to be an important growth driver for our innovative oncology portfolio. We also recently announced positive top-line results from the phase III study of TEZSPIRE in people living with eosinophilic esophagitis, EoE. A very challenging disease, as you know, which affects more than 470,000 people in the U.S.

Today, we are pleased at this point, this podium here, we are pleased to announce the phase III OPTIC-J study of TEPEZZA in Japanese patients with thyroid eye disease met both primary endpoints with no new safety findings observed. These results reinforce our efforts to reach more patients in Japan as we continue to broaden TEPEZZA's reach and footprint outside of the U.S. Beyond these programs, our late-stage pipeline is progressing well and provides additional opportunities for growth. We're advancing MariTide, dasotralimab, and xaluritamig in phase III development, and all of these programs have the potential to address areas of significant unmet medical need and to drive long-term growth for us. We continue to develop olpasiran, targeting Lp(a) for cardiovascular risk reduction. Recently, as you have seen, a competitor announced top-line results from their phase III program targeting Lp(a), raising many questions for the field.

We look forward to seeing the detailed presentation of these data to better understand the potential implications for the field and for our ongoing clinical research with olpasiran. Now moving on to our biosimilar portfolio, we're advancing a third wave of biosimilar candidates to KEYTRUDA, OPDIVO, Ocrevus, and EYLEA HD. We recently completed a phase III study of ABP 234, our biosimilar candidate to KEYTRUDA, which met both primary and secondary endpoints. These full results will support our planned regulatory submission in the second half of this year. Additionally, for ABP 206, our biosimilar candidate to OPDIVO, our Biologics License Application with the FDA has been submitted and accepted for review. We expect an FDA action on that BLA by end of the year.

As we look ahead, the business continues to do well, and we are excited about the future and our ability to deliver growth, durable growth, well into the next decade. With that, Mohit, we are happy to take your questions.

Yeah, Amgen is a very different company.

in the sense that it has grown significantly. It is more than twice the size.

Right. The portfolio has expanded significantly.

It has much more depth and breadth, as I said earlier, compared to when I joined 20 years ago for the first time. I am also a different executive coming back.