The conference call for Amgen's First Quarter 2024 Financial Results is being led by Julianne, the conference facilitator, and Justin Claeys, Vice President of Investor Relations. They will be discussing the company's performance and using non-GAAP financial measures. Bob Bradway, the company's CEO, will lead the call and highlight the company's strong momentum and growth potential, particularly with products like Repatha, EVENITY, BLINCYTO, and TEZSPIRE. He also mentions an upcoming approval for BLINCYTO that will expand its use in treating acute lymphoblastic leukemia.

In the second quarter, the pharmaceutical company Amgen saw growth in their rare disease sector and is excited about the potential of their medicine TEZSPIRE for treating chronic obstructive pulmonary disease. They are also expanding their reach by pursuing launches in new markets, indications, and formulations. The integration of Horizon, a company they acquired, is going well. They are also advancing promising new medicines in their pipeline and anticipate data readouts from 5 Phase III trials. Additionally, they announced the development of a biosimilar to KEYTRUDA. Overall, Amgen has a strong range of medicines that will enable them to meet the needs of patients and continue to grow in the future.

The company is providing additional commentary on the interim data from their Phase II trial for MariTide, a potential medicine for obesity in MariTide. They are encouraged by the results and believe it will address unmet medical needs. They are planning a Phase III program and expanding manufacturing capacity. The ongoing Phase II trial is on track for top line data in late 2024 and they are seeing a differentiated profile for MariTide. They are confident in its potential for treating obesity, obesity-related conditions, and diabetes.

The company is looking forward to completing the Phase II study and moving on to the Phase III program for MariTide. They also plan to initiate a Phase II trial for the treatment of diabetes. The company is prioritizing differentiated medicines and will not pursue further development of AMG 786. They have advanced their diverse clinical pipeline and have several upcoming milestones in 2024. The company has completed enrollment for a Phase III cardiovascular study for olpasiran, a potentially best-in-class medicine targeting Lp(a).

The company successfully enrolled over 7,000 patients in a Phase III outcome study for a cardiovascular disease treatment, which is the fastest enrollment of its size. They are also developing a first-in-class therapy for small cell lung cancer and have seen promising results in second and third-line therapy. They are now advancing the therapy to frontline treatment and hope to see similar success in eliminating residual cancer cells and improving outcomes for patients.

The company sees tarlatamab as a significant advancement in solid tumor treatment and is also making progress with their other bispecific T-cell engagers. They are also developing an oral PRMT5 inhibitor for solid tumors and have started Phase I studies for this and other potential treatments. In their inflammation portfolio, they have seen positive results in a study for COPD, but the overall patient demographic may have affected the statistical significance of the results.

The company has observed significant reductions in COPD exacerbations in patients with high baseline blood eosinophil counts and is planning for Phase III development of TEZSPIRE in COPD. They are also exploring the use of TEZSPIRE in other conditions such as eosinophilic esophagitis and chronic rhinosinusitis. The ROCKET Phase III program for rocatinlimab has successfully enrolled over 2,800 patients and is on track for top line data readout in the second half of this year. The company is also exploring the use of rocatinlimab in other conditions, such as asthma and prurigo nodularis. They have several mid- to late-stage opportunities in their rare disease pipeline, including important Phase III data readouts this year in myasthenia gravis and IgG4-related disease.

The paragraph discusses the progress and success of Amgen in the first quarter of the year. This includes the development of a new drug, Dazodalibep, for Sjogren's disease, as well as the initiation of a Phase III study for a biosimilar candidate to KEYTRUDA. The company has also seen strong sales growth, with 10 products delivering double-digit volume growth. The integration of the legacy Horizon business is going well, and the general medicines business, including Repatha, has shown an 18% year-over-year sales increase. Repatha is on track to become a multibillion-dollar business, with record sales of $517 million in the first quarter.

Repatha's expanded formulary coverage in the U.S. has led to increased volume growth, although lower net selling prices due to higher rebates have partially offset this. EVENITY had record sales, with strong growth in the U.S. and Japan. Prolia sales grew, supported by real-world evidence of its superiority in reducing fracture risk. Otezla sales also increased, but were disrupted by a cybersecurity issue in February and March.

The company is optimistic about the potential growth of Otezla, a treatment for psoriasis, due to its effectiveness, good insurance coverage, and ease of administration. They are investing in marketing efforts to educate physicians and patients about the drug. Otezla has been approved for use in pediatric patients, which is a first for the drug. Sales for Enbrel, TEZSPIRE, and TAVNEOS all saw growth in the first quarter, and the company expects continued growth in their biosimilars business.

In the first quarter, Amgen's sales in the oncology sector increased by 4%, driven by volume growth. BLINCYTO sales reached a record high of $244 million, and the drug is currently being reviewed by the FDA for a new indication. LUMAKRAS sales also reached a record high of $82 million, with potential for future growth in new markets and indications. Vectibix and KYPROLIS also saw sales growth, while Nplate sales decreased due to a government order in the first quarter of 2023. The company remains focused on serving patients with innovative therapies and rare diseases, which generated over $950 million in sales in the first quarter.

TEPEZZA, a treatment for thyroid eye disease (TED), had sales of $424 million in the first quarter, representing 5% growth compared to the legacy Horizon business. TED is assessed using the clinical activity score (CAS), which covers various symptoms such as pain, redness, and swelling. The majority of TED patients in the U.S. are in low CAS settings, and the company is focused on addressing the lack of appropriate treatment for these patients. They have generated favorable medical policy changes for over 50% of U.S. covered lives and are expanding their reach among new prescribers. The company is also increasing their focus on endocrinology and international expansion opportunities.

The company has completed regulatory submissions in various countries and has initiated a Phase III study for a new formulation of KRYSTEXXA. Sales for KRYSTEXXA and UPLIZNA have shown strong growth, and the integration of the Horizon business is going well. The company's financial performance for the first quarter has exceeded expectations and they are on track to meet their 2024 goals. The growth is driven by their pipeline and current portfolio of products.

In the first quarter, the company's non-GAAP operating expenses increased by 33% due to investments in acquired products and late-stage pipeline medicines. The operating margin remained consistent with previous guidance. Non-GAAP OI&E resulted in a $549 million expense, primarily due to increased interest expense from debt issued for the acquisition. The non-GAAP tax rate decreased and the company generated $0.5 billion in free cash flow, impacted by a planned tax deposit. The Horizon integration is on track and the company expects to reach its synergy target by year 3 post acquisition. Accretion to non-GAAP EPS is expected in 2024 and the company is on track to achieve its pre-acquisition leverage ratio by the end of 2025.

The company remains committed to its multiple capital allocation priorities, including investing in innovation, expanding manufacturing facilities, and returning capital to shareholders. They expect total revenues and non-GAAP earnings per share to increase in 2024, but R&D expenses will also increase due to investments in their late-stage pipeline. The company is focused on advancing multiple potentially first-in-class and best-in-class medicines.

The company expects non-GAAP operating expenses to grow at a comparable rate in the second and third quarters, with a normalized rate in the fourth quarter of 2023. They anticipate an improved operating margin over the next three quarters and project OI&E to be $2.6 billion. The non-GAAP tax rate is expected to be between 15% to 16%, driven by a more favorable jurisdictional mix of income. The company's capital expenditures guidance remains unchanged and they are expanding manufacturing capacity for MariTide. They project Neulasta sales of $500 million for the full year. The company is optimistic about their long-term outlook and thanks their employees for their dedication. The Q&A session will be limited in discussing obesity and MariTide, as the company's focus is on successfully completing and maintaining the integrity of the ongoing Phase II studies.

The speaker, Julianne, asks for a reminder of the process for asking questions. A caller from Goldman Sachs asks about the Phase II trial for MariTide and how it has contributed to the decision to move forward with a Phase III trial. The company's response highlights the well-designed and well-executed nature of the Phase II study and the promising results that have led to confidence in the program. Another caller from Jefferies asks for clarification on the safety metrics and the response emphasizes the ongoing nature of the study and the company's satisfaction with the results so far.

The operator introduces a question from Terence Flynn about the differentiated profile of MariTide and the areas of differentiation. Robert Bradway and Murdo Gordon provide limited details, but James Bradner mentions a comprehensive Phase III program. The operator then introduces a question from Jay Olson about the preparations for the launch of tarlatamab and the strategy behind targeting the late line market and expanding the profile in the future.

The paragraph discusses the launch and clinical development plans for a new product in Amgen's portfolio, tarlatamab, which is intended to treat small cell lung cancer. The company is well-prepared for its potential approval and has trained its field personnel and medical teams to reach treating physicians and provide broad access to the medicine. The potential of this medicine is considered a major advance in the treatment of small cell lung cancer, and the company has initiated three Phase III studies to further evaluate its effectiveness.

The company has a study comparing tarlatamab to standard chemotherapy in second line patients. They hope to test it in frontline therapy, where patients often don't get to receive second or third-line treatment. They have learned that tarlatamab works best when given early and when there is a low disease burden. They are confident in their ability to manufacture the drug and do not see it as a major challenge.

The speaker acknowledges the difficulties competitors have faced in maintaining supply of medicines and assures that their company is determined to uphold their track record of supplying every patient every time. They are confident in their ability to address technical challenges and are prepared for the clinical and commercial demands. The speaker declines to provide more information on the delivery device for their upcoming treatment.

The company recognizes the large unmet need for their medicine and is confident in their ability to supply millions of patients with their antibody-based therapies. They also mention the convenience of their monthly or less frequent dosing schedule and their confidence in meeting the challenge of supply. In terms of their larger obesity and cardiometabolic strategy, they are focused on MariTide as their lead asset and do not see oral options fitting into their portfolio at this time. They have a strong pipeline of earlier assets, both incretin and non-incretin based, but the profile of 786 did not meet their standards.

The speaker discusses the different types of medicines for obesity and how they are being developed for different patient profiles. They mention the potential for differentiation in the market with MariTide, and state that they have consistently believed in the product's ability to meet unmet medical needs. They also confirm that the interim analysis for MariTide was blinded and that there is a dose titration in the study.

The interim analysis for the MariTide study is blinded to investigators and participants to maintain the integrity of the study. Amgen plans to expand the program beyond diabetes and obesity, and is preparing for a broad Phase III program. The company is also conducting a Phase III study for rocatinlimab, an OX40-directed monoclonal antibody, and is looking to differentiate it from other treatments in the atopic dermatitis space.

The company is conducting a Phase II trial for rocatinlimab in moderate to severe atopic dermatitis with 726 enrolled patients. The trial is comparing rocatinlimab every 4 weeks to placebo with a 24-week treatment readout. The company expects a competitive profile with strong efficacy and tolerability, similar to Dupixent. The company plans to position the product effectively in the market by targeting both patients with previous biologic experience and bio-naive patients. The company also sees potential for TEZSPIRE in COPD based on the Phase II data, and plans to study it broadly in Phase III given its efficacy across different eosinophil counts.

James Shin from Deutsche Bank asked about AMG 651, an EGFR CD3 molecule in oncology. He wanted to know Jay's thoughts on this molecule.

The speaker discusses the progress of Amgen's development of CD3 bispecifics and their potential use in treating solid tumors. They also mention the ongoing Phase III study for subcutaneous administration of TEPEZZA for treating TED and address concerns about safety and potential impact on market uptake.

The speaker discusses the potential side effect of hearing loss in patients using TEPEZZA, a treatment for TED. They mention that hearing function was carefully assessed during clinical development and is now included in the warnings and precautions section of the prescribing information. The speaker also states that they are working with professional societies to increase education on this potential side effect and that it has not been a barrier for growth as physicians understand the overall risk-benefit profile of TEPEZZA. The speaker then moves on to a question about BLINCYTO, a different treatment, and whether there are plans to develop it for autoimmune disorders.

The company has been closely following the progress in CD19-directed therapeutics and the promising results from CAR T-cell therapy in systemic sclerosis and rheumatoid arthritis. They are well organized and have deep expertise in this area. The company plans to report more in the future and is working swiftly with regulators to establish safety and efficacy in Phase III studies. There is a huge unmet need in the market and the company believes they have an asset that can help address it. The specifics of the Phase III studies are still being discussed with regulators.

The study and program mentioned in the call are moving quickly within the organization and the team will be available for further questions. The company looks forward to updating on the progress in the summer after the second quarter. The call has now ended.

This summary was generated with AI and may contain some inaccuracies.