The operator, Julianne, introduces the conference call for Amgen's Fourth Quarter 2023 Financial Results. Justin Claeys, Vice President of Investor Relations, introduces the speakers and mentions the recent acquisition of Horizon Therapeutics. Bob Bradway, the lead speaker, will be followed by a review of performance by other executives. Non-GAAP financial measures will be used and forward-looking statements will be made. Amgen had a successful year in 2023 and is well-positioned for future growth.

Amgen had a successful year with double-digit volume growth and record sales for 18 of their medicines. The acquisition of Horizon adds a new rare disease business to their portfolio. Amgen also has a diverse pipeline with promising molecules in all four of their pillars of growth. Some notable developments include Phase II data for their obesity molecule, MariTide, and a June 12 PDUFA date for Tarlatamab as a third-line treatment for small cell lung cancer. Amgen hopes to expand their reach to more patients with their advanced biologics manufacturing and global presence.

The company Amgen has had success with their first BiTE BLINCYTO and plans to use the same approach with another promising BiTE in prostate cancer. They also have Phase III data for Rocatinlimab in atopic dermatitis, UPLIZNA in myasthenia gravis and IgG4-related disease, and are excited about the convergence of biotech and tech. The company has named a Chief Technology Officer and a new Head of R&D to accelerate innovation. The speaker thanks their employees for their contributions and asks Murdo to discuss the company's commercial performance in 2023.

The company had a strong year with record sales and volume growth across all regions. The General Medicine business, which includes Repatha, Prolia, EVENITY, and Aimovig, saw a 15% increase in revenue and 17% increase in volume for the full year. Repatha had a 25% increase in sales and 35% increase in volume, with strong growth in the U.S. and international markets. The company remains committed to educating physicians and patients on the benefits of Repatha for reducing the risk of cardiovascular events.

The company's bone health segment, particularly the sales of EVENITY and Prolia, saw strong growth due to the high prevalence of osteoporosis in postmenopausal women and the low treatment rates. The company also expects significant growth potential for EVENITY and will continue to focus on reaching all patients in need. In the oncology segment, sales of BLINCYTO, LUMAKRAS, Vectibix, KYPROLIS, Nplate, and XGEVA grew 5% for the quarter and 12% for the full year. BLINCYTO showed the most significant growth potential, with a 47% increase in sales, and the company sees future opportunities for LUMAKRAS in new markets and indications.

In the fourth quarter, Vectibix and KYPROLIS sales increased, while Nplate sales decreased due to timing of government orders. Otezla sales increased slightly, with new patient starts growing. Enbrel sales decreased due to changes in estimated sales deductions and lower net selling price, but there is potential for growth in the future due to its indications and payer coverage.

The paragraph discusses the strong launch trajectory of TEZSPIRE, TAVNEOS, and the biosimilars portfolio for the fourth quarter and full year, with sales increasing and plans for future growth. It also mentions the addition of the rare disease business to Amgen's portfolio and the ongoing integration activities.

In this paragraph, the speaker discusses the sales performance of their rare disease brands, specifically TEPEZZA, for the full quarter. They mention that TEPEZZA saw quarter-over-quarter growth, with positive indicators such as a record number of prescribers and favorable medical policy changes. They also highlight the potential for long-term growth in the U.S. and international markets, with regulatory review and filings underway in Japan and the EU.

The paragraph discusses the success of KRYSTEXXA, UPLIZNA, and other ultra-rare medicines in generating high sales for Amgen in the fourth quarter. It also mentions the company's plans for future growth and the addition of Jay Bradner to the R&D team.

In 2023, the company made significant progress in their clinical pipeline, with promising data from four oncology assets and three breakthrough therapy designations achieved. They also initiated pivotal Phase III studies for several drugs and are on track for a comprehensive Phase III program. They also published a manuscript on their obesity drug and have other assets in the pipeline. Additionally, their Phase III outcome study for Olpasiran has enrolled over 7,000 patients globally in just one year, demonstrating strong interest and potential impact in the medical community.

The company has expanded their initial enrollment target and is on track to complete enrollment in the first half of 2024. They are focusing on high conviction targets in oncology and have received priority review from the FDA for BLINCYTO and Tarlatamab. They are also planning to amend a study to evaluate subcutaneous administration of blinatumomab and have published promising results for their Phase Ib study. They are rapidly advancing Tarlatamab into earlier lines of treatment.

Xaluritamig, a promising new treatment for metastatic castrate-resistant prostate cancer, is progressing well in its Phase I studies. The company is also making progress with AMG 193, a drug that targets a specific genetic mutation in solid tumors. In addition, the company is exploring new indications for TEZSPIRE and is on track to present data for COPD in 2024. The company's ROCKET program for rocatinlimab, a treatment for atopic dermatitis, has successfully enrolled over 2,400 patients and is expanding to explore its potential in other conditions. The company is also making strides in its rare disease pipeline.

The company has made significant progress in advancing their pipeline, with TEPEZZA receiving orphan drug designation in Japan and a new drug application being submitted for thyroid eye disease. They also have a Phase III study underway in Japan and plan to initiate a Phase III study for subcutaneous administration of TEPEZZA. In addition, they anticipate important Phase III data readouts for UPLIZNA in myasthenia gravis and IgG4-related disease. The company is also excited about their other rare disease efforts, including Dazodalibep and Fipaxalparant, which are both on track for Phase II data readouts. The company had strong performance in the fourth quarter and for the full year, with total revenue and non-GAAP EPS growing year-over-year.

The financial results for the fourth quarter and full year of the company include the results of Horizon, which was acquired on October 6. Product sales increased by 20% in the fourth quarter and 7% for the full year, driven by volume growth. Other revenues decreased due to lower profit from a collaboration. The company managed expenses efficiently, with non-GAAP operating expenses increasing by 18% in the fourth quarter and 9% for the full year. On a non-GAAP basis, cost of sales remained flat in the fourth quarter and increased by 1.1 percentage points for the full year.

The company's full year increase in profit was due to higher profit share and changes in product mix, but was partially offset by the replacement of the Puerto Rico excise tax. R&D and SG&A expenses increased due to investments in clinical programs and the Horizon acquisition. OI&E expenses increased due to interest related to the debt issued for the acquisition, but the non-GAAP tax rate also increased due to changes in tax laws. Free cash flow decreased compared to the previous year due to costs related to the Horizon transaction and integration, repatriation taxes, and capital expenditures.

Amgen expects to continue generating strong cash flows with the addition of Horizon Therapeutics and plans to return to an efficient capital structure by the end of 2025. They prioritize investments in innovation and are increasing non-GAAP R&D spending by 8% in 2023. They are also investing in new manufacturing facilities and leveraging artificial intelligence for innovation. Amgen plans to continue returning capital to shareholders through dividends and expects revenue of $32.4 billion to $33.8 billion and non-GAAP earnings per share of $18.90 to $20.30 in 2024.

The integration of Horizon is expected to be accretive to non-GAAP EPS in 2024 and the company is on track to meet its synergies target. The revenue range reflects strong growth opportunities and a full year of legacy Horizon product sales. Other revenue is expected to be around $1.3 to $1.4 billion. R&D investments will be made to support late-stage pipeline programs. The addition of Horizon will impact the 2024 operating margin, with a projected non-GAAP operating margin of 48%. Non-GAAP operating margin growth is expected to accelerate after the first quarter for three reasons.

Amgen expects lower product sales in the first quarter of 2024, but anticipates increased spending on their commercial brands, including Repatha, Otezla, and their bone portfolio. The addition of Horizon, which was acquired in October 2023, will also contribute to their non-GAAP operating margin of 43% in the first quarter. Operating margin is expected to accelerate in the following quarters. Amgen also projects a non-GAAP cost of sales of 17-18% and a 20% increase in R&D expenses in 2024, with investments in key pipeline assets. Non-GAAP SG&A spend is expected to be between 21-22% of product sales, and non-GAAP OI&E is projected to be $2.6-2.7 billion. The guidance is driven by the jurisdictional mix of income, including the benefits of the Horizon transaction and legal entity rationalization. Amgen expects a non-GAAP tax rate of 16-17%.

In 2024, Amgen plans to make a planned payment to the IRS as an advanced deposit, which may negatively affect cash flow in the short term but could potentially accrue interest income if returned. This decision does not reflect a change in the company's belief in the merits of their legal arguments with the IRS. Amgen does not anticipate significant impacts from the adoption of the OECD 15% minimum tax in 2024, but is closely monitoring the global tax landscape for potential future effects. The company plans to continue increasing dividends and investing in their business, including the rare disease pillar. Overall, Amgen remains confident in their long-term growth and sees the rare disease pillar as a key source of growth for the company.

The paragraph discusses the financial update for Amgen and thanks the company's employees for their efforts in serving patients. The floor is then opened for questions, and the first question is about the recent publication of Phase 1 data for a potential obesity treatment. The speaker, Jay Bradner, highlights the positive results from the study, including weight loss and durability, with minimal side effects.

The speaker addresses a question about the Phase I data for their obesity medicine and explains that while the numbers are small and the duration of treatment is short, the results are directionally favorable. They are not concerned about the measurements of blood pressure and lipids in the study. The speaker also mentions that the ongoing Phase II study will explore 11 dosing cohorts and recently added a part 2 to explore more durable weight loss. This will be enabled by rapid enrollment and testing of different dosing schedules.

Robert Bradway and Jay Bradner discuss the Phase II data for 133, a potential treatment for GI side effects related to GLP-1s. They mention the possibility of dosing schedules beyond monthly and the potential to improve tolerability. They also mention that the data will be instructive in finding a safe and effective dose for Phase III clinical investigation. They address a question about the possibility of dosing 133 twice every 2 or 3 months and comment on the rollover rate of patients from Part 1 to Part 2.

The company is conducting a Part 2 study to look at durable weight loss beyond 52 weeks. Eligible patients will be rerandomized to four cohorts that will test dose level on a less frequent dosing schedule. The rate of patients rolling over to Part 2 will be established as the Phase II study progresses. The company also discussed plans for growing TEPEZZA, including an increase in unique prescribers, patient enrollment forms, and payer coverage.

The speaker discusses the importance of educating stakeholders on the updated clinical data for TEPEZZA, which will drive uptake across all TED patients. The success of this is supported by a robust patient service model. They are also excited about international opportunities and investing in innovation for the benefit of TED patients. The question then shifts to TEZSPIRE and how the company plans to differentiate given the competitive data from Dupixent. The speaker responds by discussing the efficacy bar and how investors should view the data.

The Phase II COPD study of TEZSPIRE is expected to have data in the first half of this year. It is a larger study than Dupi, targeting patients with moderate to severe COPD who are not responding to current therapy. The unique mechanism of action, which blocks TSLP signaling, has shown promise in addressing the underlying disease biology. The study will also help identify which patients will respond to the treatment. Additionally, TEZSPIRE may be able to treat a broader population of patients and those who are refractory to current therapies.

The speaker, Julian, discusses the company's strong commercial capabilities and partnerships with AstraZeneca in regards to their product in Phase III. The next question from Umer Raffat is about the discontinuation rate and liver enzyme elevation in the Phase I study of AMG 133. The speaker, Robert, cannot provide patient level insights but mentions that four out of eight patients in the high-dose cohort dropped out due to logistical reasons. He also mentions that the patients in this cohort experienced real weight loss and durable results. There is no information available about the digital group in the study.

Colin Bristow asks a question about MariTide, specifically about the dosing and the relative affinity for gip versus GLIP. Robert Bradway responds by saying that the doses are not considered high for a modern biotherapeutic product and that Amgen has the capabilities to deliver the medicine at any dose. He also mentions that MariTide differs from other peptide medicines in that it inhibits the GIP receptor rather than agonizing it.

The company feels confident in their choice to inhibit a certain receptor based on strong experimental data and genome-wide association studies. They believe that this inhibition will lead to lower BMI, as observed in large populations. They also believe that they have achieved a balance between inhibiting the GIP receptor and agonizing the GLP-1 receptor. The company has a strong team and process in place to ensure a positive and simple patient experience, based on their experience with other biologics. They will continue to work on improving patient experience. The call is almost at the scheduled time, but they will try to get through the remaining questions.

The executives of the company are discussing the performance of their product, UPLIZNA, in the treatment of NMOSD. They are pleased with its growth and success in the market and are focused on expanding its use in other autoimmune indications. They believe that UPLIZNA, with its unique targeting of CD19, has potential for treating a wide range of diseases beyond NMOSD.

The team is aware of the need for expansion and is currently prioritizing. A question is asked about the technology being used for subcutaneous delivery of TEPEZZA, but the team declines to comment. Another question is asked about the next indications for Phase III of 133 and the team discusses the potential impact on the obesity crisis.

The company is focused on developing treatments for obesity-related diseases such as cardiovascular disease, type 2 diabetes, and sleep apnea. They believe they have a strong offering in their Phase II program and are actively planning an expansive Phase III program. They will launch multiple trials in parallel and will comply with regulatory requirements before starting Phase III. The company is also developing AMG 133 and will discuss their plans once they have the necessary data and regulatory approval.

During a Q&A session, Amgen CEO Robert Bradway was asked about the company's expectations for the impact of tirzepatide on blood pressure and lipids in Phase II. Bradway stated that they are currently making all the necessary measurements but it is too early to forecast the outcome. He also mentioned that the medicine has been well tolerated in Phase I and has shown durable weight loss without significant effects on these metrics. Bradway referred to recently published preclinical data for a better understanding. Another question was asked about the plan for data disclosure and registration for Zalaritamag, a CD3 bispecific being studied for advanced castrate-resistant prostate cancer.

The company is looking to reduce monitoring and explore combinations with novel agents in the androgen receptor modulators domain. The priority is to establish reduced monitoring to reach all patients who can benefit. They are also considering the feasibility of outpatient therapy and will present their approach to the regulatory path in due course. They believe their medicine, Zalaritamag, offers a strong offering for patients with castrate-resistant prostate cancer. They are nearly complete with dose expansion enrollment and will provide data updates later this year or early next year.

The speaker, Tim Anderson, asks for clarification on comments made by Eli Lilly regarding the topic of GIP agonism versus antagonism and the data published by the company. Jay Bradner responds by stating that the argument for GIP receptor antagonism is supported by strong scientific data and human experience. Another question is then asked about the confidence in the ILT7 target for the drug Daxdilimab, and the response is that it is still early in the clinical investigation process.

During a recent conference call, David Reese, Justin Claeys, and Jay Bradner discussed the progress of a new medicine and its potential to treat autoimmune diseases. Reese stated that the medicine targets central signaling and efforts are focused on generating clinical data. Claeys asked about the difference between GIP antagonism and agonism, to which Bradner replied that it is too early to determine the effects. The call ended with a question about setting expectations for another medicine, 786.

The paragraph discusses the progress of a study for an oral medicine being developed for obesity. The study is on track for a readout in the first half of 2024 and the company plans to share more information about rare diseases in late February. The company is excited about the prospects of their medicines and will host a call in the future to discuss them further. The call concludes with a thank you to the participants and an announcement of a future call for the first quarter results.

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