Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Sales of seven innovative products, including Blincyto and Kyprolis, grew 12% year over year, contributing almost $2 billion in sales for the second quarter.
- Blincyto sales increased 28% year over year to $264 million, driven by broad prescribing across academic and community segments.
- Amgen Inc (AMGN, Financial) delivered $8.4 billion in total revenue, a 20% increase year over year, marking the highest quarterly revenues in the company's history.
- The company is positioned for future growth with upcoming biosimilar launches, including Lana (biosimilar to Stelara) and Mackenzie (biosimilar to Solaris) expected in 2025.
- Amgen Inc (AMGN) achieved favorable medical policy changes for greater than 55% of U.S. covered lives, up from 50% last quarter.
Negative Points
- Enbrel sales decreased 15% year over year for the second quarter, primarily driven by lower net selling price.
- Non-GAAP operating expenses increased 30% year over year, driven by higher royalties and profit share due to changes in sales mix.
- Non-GAAP SG&A expenses increased 36% year over year, primarily driven by the addition of Horizon.
- Free cash flow decreased to $2 billion from $3.8 billion in the previous year, driven by the timing of tax payments.
- The company expects continued declining net selling price and relatively flat volumes for Enbrel going forward.
Q & A Highlights
Q: Can you provide an update on the progress and expectations for the Phase 3 trial of Eplontersen in generalized myasthenia gravis (gMG)?
A: (James Bradner, Executive VP of Research and Development & Chief Scientific Officer) We are very excited about Eplontersen. The results in IgG4-related diseases were quite dramatic, showing a significant reduction in disease flares. For gMG, we are hopeful that this once-every-six-months CD19 B-cell depleting therapy can differentiate substantially from available treatments like steroids. The results for gMG will be available in the second half of this year.
Q: Could you speak to the clinical bar for Eplontersen in myasthenia gravis, especially given the novel steroid tapering design?
A: (James Bradner, Executive VP of Research and Development & Chief Scientific Officer) We will provide further guidance on the timing of the results from the Eplontersen study in myasthenia gravis later this year. The study includes a predefined inhibition of steroids, which is a significant aspect of the trial design.
Q: How are negotiations with CMS on Enbrel progressing, and what impact do you foresee from the Part D redesign?
A: (Murdo Gordon, Executive Vice President - Global Commercial Operations) Enbrel continues to perform well despite a competitive market. The process with CMS has concluded, and we expect the impact to be mitigated as roughly 25% of annual revenues come from Medicare Part D. We are closely watching the Part D redesign and its impact on patients.
Q: Can you comment on the positioning of your obesity treatment, Maridebart Cafraglutide, given the competitive landscape?
A: (James Bradner, Executive VP of Research and Development & Chief Scientific Officer) We are very pleased with the interim results of Maridebart Cafraglutide. The Phase 2 study is progressing well, and we remain confident that this medicine can address significant unmet medical needs in obesity and related conditions. We are rapidly initiating a broad Phase 3 program.
Q: What feedback are you receiving from clinicians on the launch of Lumakras, and how are you leveraging lessons from Blincyto?
A: (Vikram Karnani, EVP and President of Global Commercial Operations & Medical Affairs) The early feedback on Lumakras has been very positive, with strong clinical conviction from both thought leaders and community oncologists. We are leveraging lessons from Blincyto, particularly in moving from later lines of therapy to earlier lines and in combination therapies.
Q: Why did you decide to wait for 52-week data for Maridebart Cafraglutide before moving to Phase 3, unlike some competitors?
A: (James Bradner, Executive VP of Research and Development & Chief Scientific Officer) The Phase 2 study of Maridebart Cafraglutide is a large, well-conducted study that will allow us to optimize dosing and assess durability. This comprehensive data will enable us to make informed decisions for the Phase 3 program.
Q: Can you discuss the potential benefits of Maridebart Cafraglutide on parameters such as lipid levels, blood pressure, and C-reactive protein?
A: (James Bradner, Executive VP of Research and Development & Chief Scientific Officer) We are making comprehensive assessments of these parameters in the ongoing Phase 2 study. We will provide more details when we share the outcomes of the study.
Q: What are your expectations for the financial impact of the Horizon acquisition and the integration progress?
A: (Peter Griffith, Executive VP & CFO) The Horizon integration is progressing well, and we expect to achieve $500 million in pretax synergies by year three post-acquisition. We also expect accretion in non-GAAP earnings per share in 2024.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
