The paragraph is a transcript from Amgen's Third Quarter 2024 Financial Results Conference Call. Julianne, the operator, introduces the call and hands over to Justin Claeys, Vice President of Investor Relations, who introduces the session and speakers, including Bob Bradway. Bradway discusses the company's strong performance, reporting a 23% increase in third-quarter revenues to $8.5 billion, with ten products showing double-digit sales growth. He also highlights the advancement of their pipeline, particularly the progress of MariTide, a potential treatment for obesity and type 2 diabetes, with an ongoing Phase II study and plans for a Phase III program.

The paragraph outlines the progress and success of MariTide's therapeutic offerings across various medical fields. It highlights the company's performance in oncology with a 17% growth in sales and advancements in bispecific T cell engagers, mentioning BLINCYTO and the launch of IMDELLTRA, along with a Phase III development of xaluritamig in prostate cancer. The paragraph also notes a robust rare disease portfolio with $1.2 billion in sales driven by products like TEPEZZA, KRYSTEXXA, UPLIZNA, and TAVNEOS, emphasizing their early life cycle stages and potential for expansion. Additionally, it mentions UPLIZNA's breakthrough therapy designation and TEZSPIRE's 67% growth in inflammation treatment.

The paragraph discusses Amgen's business performance, highlighting strong growth and potential in their product portfolio. TEZSPIRE shows promise in COPD and other indications, while Repatha and EVENITY are experiencing significant volume growth, addressing major health issues like heart disease and osteoporosis. Amgen anticipates continued long-term growth and innovation due to its balanced portfolio and robust pipeline. Notably, third-quarter execution was strong, with 24% year-over-year product sales growth and double-digit growth in 10 products, including Repatha, TEZSPIRE, BLINCYTO, EVENITY, and TAVNEOS. Repatha's sales increased 40% year-over-year, driven by volume growth, and the company expects Repatha and Prolia to benefit over 11 million patients in 2024.

In the U.S., the primary care physician prescriber base grew by 50% year-over-year due to expanded efforts and improved reimbursement policies. Meanwhile, Repatha maintains leadership in international markets despite increased competition. EVENITY sales rose by 30% year-over-year, reaching nearly $400 million in the third quarter, with a strong U.S. market position and continued growth in Japan. Its sales are annualizing at about $1.5 billion. Prolia sales increased by 6% year-over-year, with significant volume growth in the U.S., where over 13,000 provider accounts are using it. TEZSPIRE sales reached $269 million in the third quarter, a 67% increase driven by its unique profile and rising adoption by pulmonologists to treat severe uncontrolled asthma. In contrast, Otezla sales slightly decreased by 1% despite a 5% increase in volume.

In the third quarter, the company experienced mixed financial results with a 7% decline in the net selling price offsetting volume growth. Otezla remains a key player in the treatment of milder psoriasis. Enbrel sales dropped 20% year-over-year due to unfavorable sales deductions and lower prices despite a 4% increase in volume. Biosimilar product sales rose by 9%, supported by the U.S. launch of the PAVBLU biosimilar. Future launches of WEZLANA and BEKEMV are planned for 2025. The oncology segment saw a 17% sales increase due to volume growth and price rises, with BLINCYTO sales surging 49% after a label expansion. Overall, the portfolio continues to provide strong cash flow and attractive returns.

In the third quarter, the launch of IMDELLTRA is progressing well, with $36 million in sales and strong clinical support. Sales of other products also increased: LUMAKRAS by 88% to $98 million, Vectibix by 12% to $282 million, KYPROLIS by 8% to $378 million, and Nplate by 9% to $456 million, with an 18% increase excluding government sales. The company is focusing on executing and accelerating growth for key brands. Vikram Karnani reports that the rare disease portfolio generated $1.2 billion, with TEPEZZA sales growing 8% to $488 million. To better reach thyroid eye disease patients, the field force has been reorganized into teams targeting ophthalmologists, ocular specialists, and endocrinologists.

The paragraph discusses the strategic expansion efforts for TEPEZZA, focusing on serving patients with both high and low CAS disease and building relationships with new prescribers. The company reports an 8% year-over-year growth and foresees continued growth by expanding patient access and navigating the reimbursement process. International expansion is also a priority, with TEPEZZA's recent approval in Japan and a Phase III subcutaneous study underway. Additionally, the paragraph highlights the success of KRYSTEXXA for chronic refractory gout, with $310 million in Q3 sales and a new standard of care established. UPLIZNA for NMOSD also showed significant growth, with $106 million in Q3 sales and ongoing international expansion.

The paragraph discusses the growth and potential of UPLIZNA, particularly in treating IgG4-related disease and generalized myasthenia gravis. It highlights the sales success of TAVNEOS, with a 116% year-over-year increase, and its adoption by healthcare professionals. The speaker expresses gratitude to the team involved in serving patients with rare diseases and anticipates future opportunities in the rare disease sector. James Bradner then provides an update on research and development, mentioning progress in their clinical pipeline, including a Phase II study for MariTide in type 2 diabetes and promising Phase III data for UPLIZNA. The FDA granted Breakthrough Therapy designation for UPLIZNA in IgG4-related diseases. The update also covers advancements in oncology programs and positive results for rocatinlimab in atopic dermatitis.

The paragraph provides an update on the progress of several clinical programs. MariTide is showing promise in a Phase II study for chronic weight management in obesity and type 2 diabetes, with plans for a broad Phase III program. A dedicated Phase II trial for type 2 diabetes patients, with or without obesity, has been initiated, highlighting MariTide's potential for less frequent dosing. The Phase I trial of AMG 513 is also underway, alongside preclinical programs for obesity treatments. Additionally, the Phase III cardiovascular outcomes trial for olpasiran, targeting LP(a) with siRNA technology, is advancing. In oncology, IMDELLTRA, a novel bispecific T cell engager targeting DLL3, is undergoing several Phase III studies for small cell lung cancer, with efforts to improve patient experience through reduced monitoring protocols and subcutaneous administration of tarlatamab in advanced cases.

The paragraph outlines the progress of two investigational therapies in cancer treatment. First, IMDELLTRA has shown promising results in studies for extensive-stage small cell lung cancer, with data highlighting its anticancer activity, safety profile, and survival outcomes. A Phase III trial is ongoing to compare its efficacy in combination with a PD-L1 inhibitor versus the inhibitor alone following chemotherapy. Second, xaluritamig, a STEAP1 CD3 bispecific molecule, is set to enter Phase III trials for metastatic castrate-resistant prostate cancer, based on encouraging Phase I data showing improved overall survival. The molecule is also being studied in combination therapies for earlier stages of prostate cancer.

The paragraph highlights recent developments in clinical studies for various cancer treatments. Two new Phase Ib studies are evaluating the bispecific T cell engager, xaluritamig, for localized prostate cancer management. The FORTITUDE-102 Phase III study on bemarituzumab combined with chemotherapy for gastric cancer has completed enrollment, and results from the FORTITUDE-101 study are forthcoming. Additionally, AMG 193, a PRMT5 inhibitor for MTAP-null solid tumors, has entered Phase II trials following positive Phase I results. Lastly, plans for Phase III studies of TEZSPIRE in COPD are underway in collaboration with AstraZeneca.

The paragraph discusses ongoing and upcoming clinical trials targeting various diseases. Trials are planned for COPD patients with high eosinophil counts in 2025, and TEZSPIRE is being tested for eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps, with data expected soon. Positive results have been announced for rocatinlimab in atopic dermatitis, and further studies are exploring its use in asthma and prurigo nodularis. Phase II studies for blinatumomab and inebilizumab, targeting CD19 for B-cell depletion in autoimmune diseases, initially focus on systemic lupus erythematosus. A rare disease trial, the Phase III MINT study, shows promising results for UPLIZNA in generalized myasthenia gravis across different populations.

In the MINT study, UPLIZNA showed significant improvements in myasthenia gravis symptoms after two doses by week 26, outperforming placebo. This efficacy was seen in both ACHR and MuSK-positive groups, even as corticosteroid use was tapered. UPLIZNA's potential for long-term benefits is highlighted, with further data from the study anticipated. Additionally, UPLIZNA received Breakthrough Therapy designation from the FDA for treating IgG4-related diseases, with promising Phase III data to be presented soon. The company is preparing to file these findings with regulators, expressing optimism about UPLIZNA’s impact on myasthenia gravis and IgG4-related disease.

Peter Griffith expressed satisfaction with the company's strong third-quarter performance and commitment to achieving its 2024 goals and long-term objectives. The company reported $8.5 billion in total revenues, marking a 23% year-over-year increase, with product sales rising 8% due to a 12% increase in volume. The U.S. sales were slightly affected by $173 million due to unfavorable sales deduction estimates. The firm achieved a non-GAAP operating margin of 49.6%, despite a 27% rise in operating expenses, mainly due to the acquisition of Horizon. Non-GAAP R&D spending increased by 35% to $1.4 billion, focusing on late-stage pipeline development and Horizon's programs. Additionally, non-GAAP SG&A expenses rose by 21% due to the inclusion of Horizon, but were flat without its impact. The Horizon integration is progressing well, aiming for $500 million in pretax cost synergies within three years of acquisition, with over half expected by year-end. The acquisition has positively contributed to non-GAAP EPS year-to-date and is expected to continue doing so for the full year.

The company's non-GAAP OI&E increased to a $554 million expense, largely due to interest from the Horizon acquisition, but they strengthened their balance sheet by retiring $2.5 billion in debt in the third quarter. Their non-GAAP tax rate decreased to 13.4% due to changes in earnings mix from Horizon's inclusion. In Q3 2024, the company generated $3.3 billion in free cash flow, up $2.5 billion from the previous year, facilitating long-term growth investments. They anticipate the production of over 43 million units of Repatha and Prolia in 2024 and are making further investments for products like MariTide. The company also returned value to shareholders by increasing dividends by 6% from 2023. For 2024, they project total revenues between $33.0 billion and $33.8 billion and non-GAAP EPS of $19.20 to $20. They expect lower Q4 non-GAAP EPS compared to Q3 due to planned investment increases. Additionally, they forecast new asset sales of approximately $400 million and other revenue at $1.4 billion for the full year.

The company expects TEPEZZA sales to be flat or slightly down in Q4 compared to Q3, with full-year sales increasing by about 5% from 2023. Q4 non-GAAP operating expenses are anticipated to be the highest of the year, comprising about 28% of annual expenses, due to investments in brands like Repatha and EVENITY, as well as the addition of Horizon. Overall, 2024 non-GAAP operating expenses are projected to grow by 25% year-over-year. The non-GAAP R&D expenses will also see a growth of over 25%. The anticipated OI&E, including interest on debt from the Horizon acquisition, is $2.4-$2.5 billion. The non-GAAP tax rate is expected to be 14-15%, with benefits from Horizon’s inclusion. Capital expenditure guidance remains at $1.3 billion for 2024. The company maintains a strong long-term growth outlook and appreciates its global workforce. After the financial update, the Q&A session begins with Salveen Richter from Goldman Sachs asking a question about the Phase II MariTide data.

The paragraph involves a discussion about the progress and plans for the pharmaceutical company’s development of MariTide, particularly focusing on its potential impact on type 2 diabetes and obesity-related conditions. Robert Bradway mentions that a Phase II study in type 2 diabetes has begun and is progressing well, with data expected by the end of the year. The company is also preparing for a large, global Phase III trial for obesity-related conditions and type 2 diabetes, anticipating substantial investment in R&D and manufacturing due to their confidence in the molecule’s potential. There is a request for further clarification on the cost and whether the Phase II data has been seen in-house.

In the paragraph, James Bradner discusses the progress and plans for a broad Phase III program focused on obesity, obesity-related conditions, and type 2 diabetes, emphasizing the active planning and expected initiation of the program. Robert Bradway mentions that they'll provide updated guidance on the Phase III trial and capital expenditures in the coming year, noting that the molecule fits well with their existing antibody platform. Peter Griffith highlights Amgen's strong track record in science, manufacturing, and process development, emphasizing the importance of yield and mentioning a raised capital expenditure guide to $1.3 billion. He also notes an increase in research and development spending and expresses commitment to innovation, particularly in addressing the global public health crisis. Justin Claeys then signals for the next question from the operator.

Michael Yee asks James Bradner about the company's confidence in their product MariTide and their broader portfolio, including the new program 513, given they lack an oral drug in their pipeline. James Bradner responds by expressing satisfaction with the MariTide study and their focus on developing other medicines for obesity. He mentions the ongoing study for program 513, though its mechanism of action remains undisclosed, involving subcutaneous or intravenous administration. Bradner emphasizes their interest in both injectable and oral medications, exploring various pathways to address obesity and related conditions. The company aims to remain competitive by diversifying their portfolio with different therapeutic approaches.

Robert Bradway and Vikram Karnani discuss the growth strategy for TEPEZZA, noting an 8% year-over-year increase in sales. They emphasize the importance of targeting both high and low CAS (Clinical Activity Score) patients, specifically mentioning the need for focused efforts from ophthalmologists, ocular specialists, and endocrinologists to effectively reach the approximately 80,000 low CAS patients. They have optimized their approach to expand their salesforce and enhance coverage, which began in the third quarter, and expect to see continued momentum in the coming quarters, including potential international growth in markets like Japan.

The paragraph details a discussion among company representatives about two key topics: the international expansion of TEPEZZA, particularly focusing on its upcoming launch in Japan following approval for high CAS patients, targeted for early 2025, and questions from Umer Raffat regarding MariTide's Phase I trial. Raffat queries whether the vomiting profile observed in Phase I could have been mitigated by design changes and questions the expected timeline for weight loss plateau during GLP trials, typically around six to seven months post-titration. James Bradner responds, indicating that the Phase I study followed a standard design without antecedent dose titration, limiting the insights that could be gained.

The paragraph discusses a pharmaceutical company's focus on the development and clinical trials of treatments, particularly in the area of oncology. It highlights their progress with the drug BLINCYTO, specifically its subcutaneous form, which has shown promising efficacy in prior studies. The company is preparing for a registrational study to begin in the second half of next year, reflecting its priority in developing this treatment further. The response emphasizes that there have been no significant changes affecting the study's timeline. Following this, the conversation shifts to the next question, where Terence Flynn from Morgan Stanley prepares to ask about MariTide.

The paragraph is a transcript of a discussion involving several people about an upcoming data disclosure, the Phase III planning for a drug, and the launch of a biosimilar called PAVBLU. Robert Bradway and James Bradner address the plans for releasing data related to a Phase III study, emphasizing that they are focused on obtaining the data and will disclose it in the best interest of shareholders. There is no specific update on the dosing approach for Phase III. Carter Gould from Barclays asks about the launch of PAVBLU, noting Amgen's mixed success with biosimilars and inquiring about strategies for adoption and discussions with payers. Robert Bradway then asks Murdo to share insights about Amgen's biosimilar franchise.

The paragraph discusses the excitement surrounding the launch of a new biosimilar product, PAVBLU, and other upcoming biosimilar launches like WEZLANA and BEKEMV. Murdo Gordon emphasizes the importance of being among the first to launch PAVBLU and anticipates strong early interest. They mention the significance of having permanent Q codes for reimbursement and note existing strong interest despite temporary codes. Robert Bradway talks about their successful biosimilar franchise and its attractive returns for shareholders. The conversation then shifts to a question from Christopher Schott about TEZSPIRE in COPD, highlighting earlier promising Phase II data and the competitive landscape with other products like DUPIXENT. Peter Griffith begins addressing the question, mentioning TEZSPIRE's development with AstraZeneca and its compelling Phase II study results in moderate to severe COPD.

The paragraph discusses a study involving 337 patients with exacerbations despite being on triple therapy. The study, lasting 52 weeks, compared results against a placebo and showed a 17% reduction in exacerbation rates, deriving insights from blood eosinophil biomarker studies. Consequently, a Phase III trial with AstraZeneca is planned to evaluate TEZSPIRE's efficacy in COPD. Murdo Gordon highlights TEZSPIRE's success in severe uncontrolled asthma, noting its differentiated profile and unique mechanism of action. The partnership with AstraZeneca and Amgen aims to leverage their market presence to achieve similar success in COPD.

In the article paragraph, Evan Seigerman from BMO Capital Markets asks about the launch strategy for a biosimilar product, specifically regarding stimulating demand among ophthalmologists who typically use branded products, and whether the company can offer rebates or extended invoicing. Murdo Gordon responds that while he cannot discuss specific commercial strategies, the company has a strong field force covering key customers and institutions, and they are well-prepared for the market launch. The operator then moves on to a question from Mohit Bansal from Wells Fargo, who asks about potential insights into the drug's A1C profile in a Phase II trial involving diabetes patients with obesity. Murdo Gordon notes that they expect to gain some insights into its anti-diabetic activity but will need further studies focused on patients without obesity.

In the conference call, Yaron Werber from TD Cowen asks Murdo Gordon about Enbrel's performance, noting the absence of the usual Q3 recovery and inquiring if this is a new trend or due to one-time factors. Gordon explains that Enbrel was impacted by a regular decline in net price and a significant 30% adjustment this quarter, but volume increased by 4%. Looking ahead, continued net price declines are expected. Regarding Prolia, Gordon notes that 13,000 provider accounts have treated patients with it, highlighting its widespread use and potential to support the growth of EVENITY. He expresses confidence in Prolia's market presence amid upcoming biosimilar competition.

In this passage, Gregory Renza from RBC Capital Markets poses a question to Amgen regarding their strategy for replenishing their pipeline in the rare disease sector, especially in light of recent discontinuations. Robert Bradway of Amgen responds by expressing excitement about the potential contributions to the rare disease field, emphasizing the early stage of the life cycle for their current products. He highlights their ability to add value in both domestic and international markets, aided by genetic insights. He then invites James Bradner to elaborate, who credits Amgen's acquisition of Horizon with energizing their R&D staff.

The paragraph discusses the positive impact of the Horizon acquisition on the development of rare disease medicines. The integration has been smooth, with new staff bringing valuable ideas and executing development priorities for the rare disease portfolio. A dedicated leadership initiative for rare disease drug development has been established. The organization aims to maintain Horizon's reputation for external innovation while blending it with internal efforts to enhance the rare disease pipeline. Robert Bradway expresses excitement about the new talent from Horizon, emphasizing readiness to invest further in this area. As the discussion transitions to questions, Matthew Phipps inquires about details of COPD trials, but his question remains unanswered at this time.

The paragraph discusses the impact of a recent supply disruption of Avastin in the U.S. market, highlighting that this situation might create an opportunity for the launch of PAVBLU, another treatment option. Christopher Raymond from Piper Sandler questions whether this supply issue makes the situation more interesting for the company. Murdo Gordon from Amgen responds by emphasizing the importance of a reliable supply chain in healthcare and notes that Amgen's own biosimilar to Avastin, MVASI, has benefited from these shortages, as customers are turning to them due to the supply issues with other biosimilars.

The paragraph discusses Amgen's strong position in the market, thanks to their effective manufacturing capabilities, which enable them to supply products reliably to institutional customers, individual providers, and patients. They are focusing on opportunities in the market with their product PAVBLU, especially among retina specialists who value long-term manufacturer relationships. Amgen is offering a prefilled syringe and vials to meet market demand. The paragraph also mentions a call moderated by Julianne, where participants could ask questions, with Justin and his team available for further inquiries. The call officially concludes Amgen's 2024 Q3 earnings presentation.

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