Amgen reports a 22% year-over-year increase in total revenue, reaching $7.4 billion in Q1 2024.
Non-GAAP operating expenses rose by 33% due to investments in Horizon acquired products and late-stage pipeline medicines.
Free cash flow for Q1 was $0.5 billion, a decrease from the previous year, mainly impacted by a planned $800 million tax deposit.
The company is on track to meet its 2024 full goals and long-term objectives, with a strong growth outlook driven by its innovative pipeline and in-market portfolio products.
Product Performance and Pipeline Updates
Key products such as Repatha, EVENITY, BLINCYTO, and TEZSPIRE showed significant sales growth, with TEZSPIRE sales up by 80%.
Rare disease business contributed nearly $1 billion in sales in Q1, up 14% year-over-year.
Tarlatimab, for small cell lung cancer, is awaiting approval with significant anticipation for its transformative impact.
Maritime, an obesity treatment, showed very encouraging results in interim Phase II analysis, with plans for a broad Phase III program.
The company is making additional investments based on confidence in its late-stage pipeline, with non-GAAP R&D expenses expected to increase by approximately 25% year-over-year.
Strategic Initiatives and Future Outlook
Amgen expects 2024 total revenues in the range of $32.5 billion to $33.8 billion and anticipates non-GAAP earnings per share between $19 and $20.20.
The Horizon integration is proceeding well, with the company on track to reach its pretax $500 million synergy target by year 3 post-acquisition.
Capital expenditures guidance for 2024 remains at approximately $1.1 billion, with initiatives to expand manufacturing capacity for MariTide.
The company continues to prioritize innovation, both internally and externally, with increased spending on late-stage programs and business investments for long-term growth.
Question and Answer
MariTide Phase II Trial and Phase III Clinical Investigation
Question
What were the key learnings from the MariTide Phase II trial that led to confidence in progressing to a Phase III program?
Answer
The Phase II trial was well-designed and well-executed, providing valuable insights into the medicine’s dosing and efficacy profile.
The data suggests a broad and differentiated profile, supporting the advancement to a Phase III clinical investigation.
MariTide Interim Analysis and Safety
Question
Did the interim analysis consider all doses of MariTide, including the highest doses, and evaluate safety metrics like bone health?
Answer
The ongoing study’s interim analysis considered all doses and safety metrics, and the company is pleased with the results to date, allowing for rapid progression to the Phase III program.
All arms of the study remain active, and there have been no issues with patient dropout.
MariTide Differentiation and Benchmarking
Question
In what areas does MariTide demonstrate differentiation, such as efficacy, tolerability, and dosing interval, and what benchmarks are being considered (e.g., semaglutide, tirzepatide)?
Answer
The company is confident in MariTide’s differentiated and broad profile compared to both in-market products and those in clinical development.
The Phase III program is being planned comprehensively and competitively, considering the dynamic landscape of obesity medicines.
Tarlatamab Launch and Development Strategy
Question
What preparations are being made for the potential launch of tarlatamab, and what is the strategy behind the initial launch in the late-line setting and the expansion of its profile?
Answer
The company is well-prepared for the potential approval and launch of tarlatamab for small cell lung cancer, with extensive training for field teams and clear plans for physician engagement and access.
The launch strategy focuses on addressing the significant unmet need in small cell lung cancer, particularly in the late-stage setting.
Tarlatamab Phase III Development Program
Question
Can you provide an overview of the three Phase III studies initiated for tarlatamab and their design rationale?
Answer
The Phase III program includes a study comparing tarlatamab to standard of care chemotherapy in the second-line setting, with a primary endpoint of overall survival.
Two additional trials in extensive and limited stage small cell lung cancer evaluate the contribution of tarlatamab following upfront therapy with response, based on learnings from BiTE molecule development.
The design aims to bring tarlatamab to earlier lines of therapy, where it is expected to have a significant impact.
AMG 133 Manufacturing Complexity and Capacity
Question
How does the manufacturing complexity and cost of AMG 133 compare to traditional diptheria-based therapies, and what level of manufacturing capacity is the company aiming for?
Answer
The company is not intimidated by the manufacturing challenges of AMG 133, as it falls within their expertise as a world leader in biotherapeutic manufacturing.
The goal is to establish a manufacturing process that ensures consistent supply for all patients, with a focus on maintaining a track record of reliability and accessibility.
The specific investment required for manufacturing capacity will be addressed in the future, but the company’s capital expenditure guidance accounts for the necessary activities.
AMG 133 Delivery Device and Manufacturing Scale-Up
Question
Can you provide more details on the expected delivery device for AMG 133 (e.g., pen device) and the scale-up of manufacturing capacity to meet potential demand?
Answer
The company is not providing further details on the specific delivery device at this time but emphasizes that it will be patient-friendly and convenient.
Amgen’s experience in serving millions of patients with antibody-based therapies, such as Prolia, demonstrates their capability to scale up manufacturing and supply chain operations.
The less frequent dosing schedule of AMG 133, likely monthly or less, implies a lower requirement for injection devices compared to competitors with weekly therapies.
MariTide and Oral Options in the Portfolio
Question
Given the focus on MariTide and its convenience, how is the company thinking about the role of oral options in the obesity and cardio-metabolic portfolio?
Answer
The differentiated profile of MariTide sets a high bar for Amgen’s obesity medicines, and the company believes in the importance of having a diverse portfolio to address the heterogeneity of the market and patient needs.
Amgen’s pipeline includes both oral and injectable options, and the company is committed to developing medicines with different profiles to meet the various needs of patients with obesity and related conditions.
MariTide Differentiation Based on Phase I Data
Question
Can you remind us of the differentiation opportunities that were identified based on Phase I data, without commenting on the recent Phase II interim analysis?
Answer
The company has been consistent in its belief that MariTide has a broad opportunity for differentiation in the market, with a differentiated profile on multiple fronts.
These differentiation opportunities were identified based on Phase I data and continue to be a key focus as the Phase III program is being planned.
Mirati Interim Analysis Blinding and Dose Titration
Question
Was the interim analysis for Mirati’s study blinded, and is there a dose titration in the study design?
Answer
The interim analysis was not blinded to the company’s R&D leaders, who have seen the assigned treatment arms, but it was blinded to investigators and participants to maintain study integrity.
The company does not provide information on dose titration in the study.
MariTide Program Expansion Beyond Diabetes and Obesity
Question
Are there any updated thoughts on expanding the MariTide program beyond diabetes and obesity, considering the evolving understanding of its safety and tolerability profile?
Answer
The company’s plans for MariTide remain consistent with its original intent, and a broad Phase III program is being prepared to address the unmet needs in various obesity-related conditions, including diabetes.
There are no current plans to expand the program beyond these areas.
Rocatinlimab Differentiation and Positioning
Question
What differentiation factors are you looking for in the upcoming Horizon ROCKET study for rocactinlimab, and how do you plan to position it against established competitors like DUPIXENT and RINVOQ in the atopic dermatitis space?
Answer
The company is limited in discussing the differentiation factors for rocactinlimab until the study results are available, but the Phase III HORIZON study in atopic dermatitis is well-powered and designed to demonstrate a competitive profile with strong efficacy and excellent patient experience.
The company’s experience with launching Tezspire and differentiating it from DUPIXENT in a different indication using a highly differentiated mechanism provides confidence in its ability to position rocactinlimab effectively in the atopic dermatitis market.
TEZSPIRE Role in COPD and Phase III Development
Question
Can you elaborate on TEZSPIRE’s potential role in COPD based on the Phase II data and discuss the planned Phase III development strategy, considering its efficacy across different eosinophilic subgroups?
Answer
The Phase II COPD data for TEZSPIRE will be presented at the American Thoracic Society Meeting, and the company is limited in sharing details until the embargo is lifted.
The rationale for TEZSPIRE in COPD is based on its mechanism of action targeting type 2 inflammation, similar to asthma.
The Phase II trial design included predefined stratifications for analysis, such as an eosinophil threshold of 150 cells per microliter, to account for the heterogeneity of COPD.
AMG 651 (EGFR CD3 Bispecific) Development
Question
Can you provide any insights into the development of AMG 651, an EGFR CD3 bispecific antibody, and its differentiation and positioning in the oncology landscape?
Answer
The company has extensive experience in developing CD3 bispecifics and is actively studying AMG 651 and other solid tumor-targeting T-cell engagers.
The company is confident in the potential of these therapies, guided by the success of tarlatamab and other programs.
TEPEZZA Subcutaneous Program and Safety Concerns
Question
Can you provide an update on the TEPEZZA subcutaneous program, including the ongoing Phase III study, and discuss any insights from the clinical experience regarding safety concerns and their potential impact on uptake?
Answer
The development of a subcutaneous formulation of TEPEZZA is a major priority, with a Phase III study initiated in moderate to severe active TED, similar to the intravenous label-enabling studies.
The company has addressed safety concerns related to hearing impairment with TEPEZZA by including relevant information in the product label, recommending assessment and monitoring, and working with professional societies to increase education.
These measures have not been a significant barrier to TEPEZZA’s growth, as physicians generally understand the favorable risk-benefit profile of the medicine.
BLINCYTO Development in Autoimmune Disorders
Question
Given the recent academic data suggesting activity in rheumatoid arthritis (RA), are there any plans or considerations for developing BLINCYTO in autoimmune disorders?
Answer
The company, with its expertise in CD19-directed therapeutics and inflammation/autoimmunity, is actively exploring the potential of BLINCYTO in autoimmune disorders, inspired by the early evidence from CAR T cell therapy and recent reports in systemic sclerosis and refractory RA.
Further details on this exploration will be shared in the future.
MariTide Phase III Study Design and Timing
Question
Do you have an estimate of when the MariTide Phase III studies could start, their potential size and design, and any strategies to accelerate the studies and incorporate both U.S. and ex-U.S. sites?
Answer
The company is committed to completing the Phase II study and working swiftly with regulators to define the Phase III program for MariTide, acknowledging the significant unmet need in the market.
The program is progressing as rapidly as possible within the organization, and specific details on study design, size, and timing will be shared as they become available.
