Amgen Inc., the world's largest independent biotechnology company, is well-positioned for long-term success as it continues to deliver innovative medicines that make a significant difference for patients suffering from serious diseases. With a diverse portfolio of established products, a promising pipeline of potential first-in-class and best-in-class therapies, and a strong financial foundation, Amgen is poised to drive sustainable growth through the end of the decade and beyond.

Financials

In the fiscal year 2023, Amgen reported annual net income of $6.717 billion, annual revenue of $28.19 billion, annual operating cash flow of $8.471 billion, and annual free cash flow of $7.359 billion. These robust financial results demonstrate the company's ability to consistently generate substantial earnings and cash flow to fund its strategic priorities.

During the first quarter of 2024, Amgen delivered impressive results, with total revenues increasing by 22% year-over-year to $7.447 billion. This growth was driven by a 25% increase in product sales, including a $914 million contribution from the acquired Horizon Therapeutics portfolio. Excluding the Horizon acquisition, Amgen's product sales still grew by a healthy 6% year-over-year, reflecting 9% volume growth across the company's key brands.

Business Overview

Amgen's strong performance was underpinned by robust growth across its four therapeutic pillars: general medicine, oncology, inflammation, and rare disease. In the general medicine segment, Repatha sales increased by 33% year-over-year to a record $517 million, driven by a 44% volume growth partially offset by a 13% decline in net selling price. EVENITY also delivered record sales of $342 million, up 35% year-over-year, supported by volume growth in both the U.S. and Japan.

In the oncology portfolio, BLINCYTO sales grew by 26% year-over-year to $244 million, reflecting broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia. LUMAKRAS sales increased by 11% to $82 million, and Vectibix sales rose by 6%, driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact.

Amgen's inflammation business saw Otezla sales increase by 1% year-over-year, with strong new patient volume growth in the U.S. early in the quarter, which was temporarily disrupted by a cybersecurity issue at a key specialty pharmacy partner. The company has since seen a return to accelerating new patient prescription growth in recent weeks and remains confident in Otezla's significant growth potential.

In the rare disease pillar, Amgen's acquired Horizon Therapeutics portfolio delivered impressive results, with TEPEZZA generating $424 million in sales, KRYSTEXXA recording $235 million, and UPLIZNA achieving $80 million in net sales, representing year-over-year growth of 5%, 26%, and 49%, respectively. Amgen is actively pursuing international expansion opportunities for these rare disease products, as well as exploring new indications and formulations to further enhance their patient impact.

Outlook

Looking ahead, Amgen provided guidance for 2024, expecting total revenues in the range of $32.5 billion to $33.8 billion and non-GAAP earnings per share between $19 and $20.20. This outlook reflects the company's confidence in its ability to drive continued growth through its innovative pipeline and robust in-market portfolio.

Recent Developments

Amgen's pipeline is brimming with promising candidates across its four therapeutic areas. In oncology, the company is eagerly awaiting the potential approval of tarlatamab, a first-in-class BiTE molecule targeting DLL3 for the treatment of small cell lung cancer. Amgen has initiated three Phase III studies to evaluate tarlatamab in earlier lines of therapy, recognizing the importance of directing the T-cell in a manner that can effectively eliminate residual cancer cells and improve outcomes for patients.

In inflammation, Amgen is advancing rocatinlimab, a first-in-class anti-OX40 monoclonal antibody, through a robust Phase III program in moderate to severe atopic dermatitis. The company is also exploring the potential of TEZSPIRE, its TSLP inhibitor, in chronic obstructive pulmonary disease (COPD), where it demonstrated clinically meaningful activity in a recent Phase II study.

Amgen's rare disease pipeline is equally impressive, with UPLIZNA, dazodalibep, and other assets advancing in late-stage trials for indications such as myasthenia gravis, IgG4-related disease, and Sjögren's disease, respectively. The company's acquisition of Horizon Therapeutics has further strengthened its rare disease portfolio, providing first-in-class, early-in-lifecycle medicines like TEPEZZA and KRYSTEXXA.

In the area of cardiometabolic diseases, Amgen is making significant strides with its obesity program, highlighted by the promising interim results from the Phase II study of MariTide. The company is actively planning a broad Phase III program for MariTide, including in obesity, obesity-related conditions, and diabetes, recognizing the substantial unmet need in this therapeutic area.

Liquidity

Amgen's financial position remains robust, with a strong balance sheet and ample liquidity to fund its strategic priorities. The company continues to prioritize investing in innovation, both internally and through external partnerships and acquisitions, while also returning capital to shareholders through dividends and share repurchases. Amgen's commitment to financial discipline and efficient capital allocation is evident in its plans to maintain its pre-acquisition leverage ratio by the end of 2025, following the successful integration of Horizon Therapeutics.

Furthermore, Amgen is at the forefront of leveraging transformative technologies, such as generative AI, to drive innovation and enhance its drug development capabilities. The company's strategic investments in state-of-the-art manufacturing facilities, including the new North Carolina and Ohio sites, underscore its dedication to ensuring a reliable supply of its innovative therapies to patients worldwide.

Conclusion

In conclusion, Amgen's diverse portfolio of established products, promising pipeline of potential first-in-class and best-in-class therapies, and strong financial foundation position the company for continued growth and success. With its unwavering commitment to innovation, patient-centricity, and operational excellence, Amgen is well-equipped to deliver groundbreaking treatments that address the unmet medical needs of millions of patients around the globe.