The operator introduces the conference call and explains the format. Justin Claeys, Vice President of Investor Relations, then introduces the speakers and mentions the use of non-GAAP financial measures and forward-looking statements. Bob Bradway, the first speaker, expresses gratitude for the attendees and discusses the company's strong performance and confidence in long-term growth. He also mentions the focus on providing innovative medicines for challenging diseases.

The second quarter saw a 20% increase in revenues, with several medicines, including Repatha and EVENITY, experiencing double-digit sales growth. The rare disease sector also performed well, with KRYSTEXXA, UPLIZNA, and TAVNEOS all showing strong growth. The company's pipeline also looks promising, with over a dozen significant milestones expected in 2024. Notable achievements in the second quarter include the accelerated approval of IMDELLTRA for small cell lung cancer and BLINCYTO for frontline treatment of B-cell precursor acute lymphoblastic leukemia. Additionally, impressive Phase III data was announced for UPLIZNA in IgG4-related disease, a condition with no currently approved treatments.

In the second quarter, Amgen saw a 20% increase in sales, with strong performance in all regions and double-digit growth for 12 products, including Repatha, TEZSPIRE, EVENITY, TAVNEOS, and BLINCYTO. The General Medicine portfolio, including Repatha, EVENITY, and Prolia, saw a 20% increase in sales driven by volume growth. Repatha sales specifically increased by 25% and is on track to become a multibillion-dollar business. However, this growth was partially offset by lower net selling prices.

The paragraph discusses the success of Repatha, EVENITY, Prolia, TEZSPIRE, and Otezla in the U.S. and Japan. Repatha has seen increased recognition and access, leading to volume growth. EVENITY sales have increased due to both existing and new prescribers. Prolia sales have also increased, supported by real-world evidence. TEZSPIRE has strong growth potential and Otezla sales have decreased due to lower net selling price and changes to estimated sales deductions.

In the second quarter, the U.S. saw a 3% growth in new patient prescriptions, with Otezla being a strong player in the increasingly competitive dermatology market. Enbrel sales decreased due to lower net selling price, but it remains a trusted and effective option for physicians. The biosimilar business is expected to grow with upcoming launches in 2025. In oncology, sales of seven innovative products grew by 12%, with BLINCYTO being a top performer with 28% growth.

In the second quarter, the Food and Drug Administration approved BLINCYTO as a frontline consolidation treatment for patients with Philadelphia chromosome-negative B-cell ALL. The company is working to establish BLINCYTO as a standard of care in this setting. LUMAKRAS sales increased 10% year-over-year and the company sees future growth opportunities for the drug. Other drugs, such as KYPROLIS and Nplate, also saw strong performance. The company also had a successful launch of IMDELLTRA for the treatment of extensive stage small cell lung cancer. In rare disease, TEPEZZA sales were $479 million in the second quarter, reflecting growth of 8% year-over-year and 13% quarter-over-quarter.

The main growth opportunity for the company is in the 80% of thyroid-eye disease patients with a low clinical activity score. The company is expanding its reach to new prescribers and increasing focus on endocrinology. They are also improving access for patients and have achieved favorable medical policy changes for over 55% of U.S. covered lives. International expansion is also a growth opportunity, with plans for launches in multiple countries. The company is also working on a subcutaneous formulation of TEPEZZA and has seen strong sales growth for KRYSTEXXA and UPLIZNA.

In the second quarter, the company made significant progress in their clinical pipeline, receiving two approvals and a breakthrough therapy designation. They also shared positive data for several programs and are eagerly awaiting additional data later this year. They remain confident in the potential of their drug MariTide to address unmet medical needs in obesity, obesity-related conditions, and type 2 diabetes, with plans to initiate Phase III trials in the future.

The company is making progress in their early obesity programs and expects one to enter clinical development later this year. They also have a Phase III cardiovascular outcomes trial for their Lp(a) targeting medicine, which is a genetically defined risk factor for cardiovascular disease. In oncology, they have a first-in-class bispecific T-cell engager approved for the treatment of small cell lung cancer. They are rapidly advancing this therapy into frontline therapy and have completed enrollment for a confirmatory Phase III study. This is the first bispecific T-cell engager approved for a common solid tumor.

The study of tarlatamab in earlier lines and in the context of lower tumor burden has drawn from the success of BLINCYTO in treating B-cell acute lymphoblastic leukemia. This has led to the FDA approving an additional indication for BLINCYTO and ongoing studies to expand its impact. The first-in-class STEAP1 CD3 bispecific molecule, xaluritamig, has also shown promise in treating metastatic castrate-resistant prostate cancer, and further studies are being conducted to explore its potential in earlier stages of the disease. Overall, these advancements demonstrate the potential of bispecific T cell engager therapy.

The company has made significant progress in its oncology division, with the completion of enrollment for a Phase III study of bemarituzumab for gastric cancer and the advancement of AMG 193 for solid tumors. In the field of inflammation, the company is planning for Phase III development of TEZSPIRE for COPD and has received FDA designations for its use in COPD, eosinophilic esophagitis, and chronic rhinosinusitis. The company is also conducting a comprehensive Phase III program for rocatinlimab in atopic dermatitis.

The company is exploring the potential of rocatinlimab in additional indications, including moderate to severe asthma and prurigo nodularis. They are also excited about the advancements in their rare disease pipeline, particularly with UPLIZNA, which has shown positive results in a Phase III trial for immunoglobulin G4-related disease. They are also studying UPLIZNA in generalized myasthenia gravis through a Phase III study. The company is investigating the efficacy of UPLIZNA in two different antibody serotypes and attempting to demonstrate efficacy while removing the treatment benefit of steroids.

In the MINT trial, patients on steroids had a specified taper and data readout is expected in the second half of 2024. Amgen is launching a development program targeting CD19 positive B cell-mediated autoimmune disease with UPLIZNA and blinatumomab. In May, BEKEMV was approved as the first interchangeable biosimilar to Soliris. Biosimilar development is also underway for ABP 234 and a biosimilar candidate to KEYTRUDA and ABP 206. Amgen is on track with their 2024 goals and has a strong long-term growth outlook driven by their innovative pipeline and in-market products. In the second quarter, they delivered $8.4 billion in total revenue, a 20% increase year-over-year.

Amgen reported its highest quarterly revenue in history with a 26% increase in volume, indicating more patients are receiving their medicines. Excluding the addition of Horizon, product sales increased by 5%, driven by a 10% increase in volume. Operating margin was 48.2% and non-GAAP expenses increased by 30% year-over-year. The company invested in its late-stage pipeline and saw an increase in interest expenses due to the Horizon acquisition. They plan to retire over $10 billion of debt by the end of 2025 and generated $2.2 billion in free cash flow in the second quarter.

The Horizon integration is going well and is expected to result in $500 million in pretax synergies by year three. Non-GAAP earnings per share are expected to be accretive in 2024. The company is investing in innovation, expanding manufacturing facilities, and opening a new global technology and innovation center. They are also returning capital to shareholders through dividends. For 2024, total revenues are expected to be between $32.8 billion and $33.8 billion, with non-GAAP earnings per share between $19.10 and $20.10. R&D expenses are expected to increase by more than 25% year-over-year to support late-stage pipeline studies.

The company projects a lower non-GAAP operating margin for the third quarter and expects expenses to grow at a similar rate. They also anticipate a $2.5 billion OI&E, including interest expenses related to a recent acquisition. The company plans to expand manufacturing capacity and increase capital expenditures in 2024. The CEO expresses gratitude to employees and opens up for a Q&A session. The first question is about the UPLIZNA program, with the completion date for the MINT study being pushed back to mid-May. The company has posted new job openings and has a presentation scheduled for October 15 at the MGFA. The CEO discusses the use of steroid tapering in the trial and what they hope to see from the data.

The speaker is excited about the results of UPLIZNA, a CD19 B-cell depleting monoclonal antibody, in treating IgG4-related disease. The results have shown a remarkable reduction in disease activity and the potential to get patients off steroids. The results for myasthenia gravis, which also include a steroid taper, are expected in the second half of the year and the speaker cannot provide further details on the timing. The clinical bar for UPLIZNA in myasthenia gravis will be evaluated on both a placebo-adjusted and absolute basis. The speaker also mentions an upcoming presentation at the MGFA scientific session, but does not provide any further information on that.

The speaker discusses the success of UPLIZNA in liberating patients from steroids and mentions that the results will be revealed in the second half of the year. The next question is about negotiations with CMS for Enbrel and the impact of Part D redesign. The speaker states that Enbrel continues to do well in the market and that a quarter of its revenues come from Medicare Part D. They also express concern about the CMS price reduction not incentivizing innovation and mention that they will continue to support patients. The speaker then pivots to discussing obesity.

The company is confident in their injectable product, MariTide, for treating obesity and diabetes. They have seen positive results in their Phase II study and are moving quickly to initiate a Phase III program. Although there is competition in the space, the company remains confident in the potential of their product. The market for GLP-1-based weight loss treatments is expanding, which further supports the potential success of MariTide.

Jay and Umer are discussing the development plan for MariTide, a weight loss medication. Jay believes that the Phase II data, which will be available at the end of the year, will be valuable in showing the drug's impact on obesity. The Phase II study is much larger than the Phase I study and includes 592 patients with different dosing options. Jay also mentions that the drug has shown persistent weight loss in previous studies. Umer asks about competitors moving forward with Phase III trials with smaller data sets, and Jay explains that they are being conservative and following FDA feedback. They also briefly discuss an increase in CapEx, which Jay attributes to the API and other factors.

The company is confident about the success of their new drug, IMDELLTRA, and is receiving positive feedback from clinicians. They are also working to expand manufacturing capacity and expect a higher CapEx in 2024. They are leveraging lessons learned from their previous drug, BLINCYTO, and are quickly establishing care pathways for patients. The drug is being well-received by thought leaders and community oncologists, and the company is working to increase awareness and facilitate safe and easy treatment for patients.

Jay Bradner discusses the potential of MariTide as a major transformation in the treatment of a certain disease. He notes that the company is leveraging the learnings from BLINCYTO to expedite the development of IMDELLTRA for frontline small cell lung cancer therapy. The company is also optimistic about applying these lessons to xaluritamig. A question is asked about the potential differences in profile between MariTide and another drug, and the importance of parameters such as lipid blood pressure and C-reactive protein in designing a Phase III trial.

The speaker thanks Mohit for his interest and explains that they are currently focused on completing the MariTide Phase II study before sharing more information about the differentiated profile. They are taking a comprehensive approach to optimize the dose, schedule, and impact of the medicine. The next question is about the obesity franchise and the speaker shares that they are using a multifactorial assessment to determine which program will enter clinical development later this year. They are interested in exploring both the incretin pathway and other novel targets, supported by strong preclinical development packages. The decision to resource a medicine for human clinical investigation requires a high degree of conviction.

The company is planning to advance a new medicine for obesity in clinical investigation in the second half of the year. They are not giving specific dates for the Phase III trial due to competition in the field. The company's litigation case is still ongoing and they are confident in their position and reserves. The tax court has recently reinforced the value of manufacturing in Puerto Rico.

Amgen is confident in their current position and is looking forward to presenting their case. They have been in the same place of confidence for the past 2.5 to 3 years. In response to a question about margins in 2025, they do not provide long-term margin guidance but are committed to investing in innovation and will flex out margins if there are opportunities for strong returns. This year, they see an opportunity to make investments in research and development, with a focus on development, which has increased by 30% year-over-year in the quarter and is expected to increase by over 25% for 2024. They are always focused on productivity and prioritization to generate capital for innovation.

Amgen has a new program called technology and workforce strategy that is moving quickly. They are opening a talent and innovation center in India and are focused on preserving margins, reallocating capital, and being disciplined spenders. A question was asked about their plans for MariTide in a Phase II diabetes study. Amgen plans to initiate a dedicated Phase II study later this year, which is not a gating step for their Phase III program for obesity. This new study will allow them to optimize dosing for diabetic patients. Amgen believes that MariTide has the potential to be a highly efficacious treatment for diabetes, which would differentiate it in the market.

The speaker discusses the benefits of controlling hyperglycemia and improving adherence and persistence with monthly dosing. They also address a question about muscle preservation in patients losing weight on glip and mention ongoing research in this area. They plan to make similar measurements in their own study and are interested in other organizations' efforts to support muscle loss with obesity medicines. They will take two more questions before ending the call.

During a conference call, a question was asked about a new obesity asset that is set to enter clinics later this year. The speaker, Jay Bradner, did not provide any further details but mentioned that the company is interested in various pathways and forms of treatment for obesity. The call also addressed the progress and potential of TEPEZZA, a treatment for a rare disease. The company is pleased with its execution and is focused on expanding access to the treatment for patients with lower clinical activity scores. They also mentioned the potential impact of the Japanese market and the resources being put towards the rare disease portfolio.

The company is seeing significant momentum in expanding its prescriber base for TEPEZZA and has achieved favorable medical policy changes for over 65% of covered lives in the U.S. They expect continued growth for TEPEZZA in the U.S. and are also looking forward to launching in Japan next year. The company is on track with its synergy targets and expects to see more leverage as they take control of the supply chain for rare disease products. They are also confident in their ability to meet the needs of rare disease patients and are optimistic about their position in the market.

The speaker thanks everyone for participating in the call and mentions that they have gone over the set time. They look forward to regrouping after the third quarter. The operator then concludes the call.

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