A：In 2025, the company advanced key programs across all phases of development, furthering its mission to deliver transformative medicines and vaccines that improve health outcomes for patients globally. They are proud of the significant progress made and remain focused on bringing forward breakthrough science and innovation to create sustainable long-term value for patients and shareholders.

A：As a result of the company's progress, they now have a line of sight to over $70 billion of potential commercial opportunity by the mid-2030s, which is $40 billion more than just a year ago and more than double consensus 2028 peak cray revenue of 35 billion.

A：Key developments include Phase Ii results for an oil PCSK9 inhibitor that underscore the practice-changing potential of the drug for cardiovascular disease, a leading cause of death globally. They also announced Phase Ii top line findings from the Cadence trial supportive of continued development for a different type of pulmonary hypertension. In HIV, they shared positive top line results for atroviride combination with therabond for treatment-naive adults living with HIV. Additionally, Lyotard and Sac TMT, investigational tropo II directed antibody drug conjugates, were granted commissioners' national priority beucher by the FDA, potentially expediting their review.

A：The company completed the acquisition of S.A., which complements their portfolio and builds their legacy in combating infectious diseases. They also highlighted the promising results of phase 2 for MBA 1406, a potentially first-in-class long-acting antiviral candidate designed to prevent influenza infection. The company is excited about the potential of this preventative antiviral agent, which they believe could have over $5 billion in revenue potential and be a meaningful driver of growth later in the decade.

A：The company expects strong growth in their animal health business, the addition of new early phase programs entering Phase Ii in the near term, and additional potential science-led, disciplined, and value-enhancing business developments. They are entering a robust period with first-time phase Ii data readouts from novel candidates, which include Azlocillin combined with Le Gapper beer for potentially the first once-weekly oral treatment regimen for people living with HIV, and Ink 3000, a new mechanism of action for retinal diseases.

A：Recent performance in oncology has been marked by the continued strength of Keytruda, with global sales increasing 5% to $8.4 billion. This growth is driven by robust uptake in earlier-stage cancers and strong demand from metastatic indications that primarily affect women, such as breast, cervical, and endometrial cancers. However, growth was negatively impacted by approximately 200 million due to timing of purchases in the US.

A：The expected sales following the implementation of a permanent J code in the US are $35 million, with the impact expected to be felt in the beginning of April. This is anticipated to have a significant positive effect on patients and healthcare systems.

A：The oncology portfolio achieved strong growth with sales increasing 37% to $220 million. This was primarily driven by increased use in patients with previously treated advanced renal cell carcinoma in the US and uptake from ongoing launches in certain international markets. Sales in the US also grew 7%, mainly due to pricing on neuromoev cel.

A：Garda Silk sales decreased by 35% to $1 billion, which was attributed to lower demand in China and Japan. However, other international markets experienced growth of 8%, driven by the timing of purchases.

A：The Cap VA launches performed well with sales of $279 million, influenced by demand from both retail and non-retail customers, including seasonal immunization activity in the US. In contrast, sales in RSE in flonzie were $21 million, initially constrained by a lower than expected infant immunization rate and high levels of RSV monobloc antibody.

A：Overall sales were $467 million, driven by the continued strong demand for the treatment in the US, with more than 1500 new patients prescribed and over 27,000 total prescriptions dispensed. O2 VA for the maintenance treatment of COPD saw sales of $178 million, with the acquisition of Verona on October 7 contributing to strong growth in new patients started and total patients treated.

A：The animal health business experienced strong growth with sales increasing 6%, with livestock sales growing 9% and companion animal sales remaining flat due to new product launches offset by a reduction in vet visits.

A：The non-GAAP basis is used for a financial discussion that excludes certain charges to provide an alternative view of the company's financial performance. Gross margin was 79.7%, and operating expenses decreased to $6.8 billion, with a charge of $150 million related to a rights agreement and lower than a year ago due to business development charges.

A：The company provided non-GAAP guidance for 2026 with revenue expected between $65.5 and $67 billion, representing 1 to 3% growth, including a positive impact from foreign exchange. Gross margin is assumed to be approximately 82%, operating expenses between $35.9 and $36.9 billion, and other expense of approximately $1.3 billion. The tax rate is 15.4%, leading to earnings per share of $2.40. Share repurchases are assumed to be about $3 billion, and the company aims to maintain a balance without cash build-up on the balance sheet.

A：The phase 3-outcome study for Wind River is ongoing and fully enrolled.

A：The purpose of the Phase 3 anchor study is to evaluate a potentially first-in-class long-acting, antiviral, strain-agnostic prophylactic for the prevention of seasonal influenza, specifically in individuals at high risk of serious complications.

A：The investigation into the one daily single tablet, 2-drug regimen of derain and aslo, which leverages translocation inhibition from a phase 3 study in previously untreated adults with HIV-1 infection, demonstrated non-sinusoidal II and safety compared to a broadly used three-drug regimen.

A：The studies on intruder and Keytruda showed that they are effective in treating a wide spectrum of cancers, with notable developments including FDA approval for both drugs in combination with a specific agent for adjuvant treatment in bladder cancer and positive top line results from the phase three Keynote B15 study demonstrating improvements in event-free survival, overall survival, and pathologic complete response rates.

A：The Keynote 942 study and the ongoing phase 3 interpath 0 0 1 trial are significant as they evaluate the candidate neoantigen therapy in combination with pembrolizumab in patients with high-risk stage 3 or 4 melanoma and assess the recurrence-free survival and other outcomes.

A：The European Commission approved the subcutaneous injection of pembrolizumab for use in all 33 indications for adult patients, making it the first and only subcutaneous immune checkpoint inhibitor that can be administered rapidly in Europe.

A：There are two ongoing phase 3 studies evaluating Boma deta in essential thrombocythemia and an orphan disease. Significant milestones expected in 2025 include a February 2025 date for certain patients with platinum-resistant recurrent ovarian cancer based on the Keynote V 96 trial, a May 2025 presentation of detailed findings at ASCO for a first in class oral HIF 2 alpha inhibitor, and an April 28, 2025, PDUFA date for grazoprevir and the L冕bora once daily or two drug treatment regimen.

A：The thoughts on running the full trial are centered around ensuring the trial is adequately powered with strong data across various subpopulations important for future labels. This is an event-driven trial, and while specific communication plans following interim analysis have not been disclosed, the severity of the flu season highlights the importance of the model completed in the Northern Hemisphere and the ongoing parallel recruitment in the Southern Hemisphere.

A：The development strategy regarding first line CP patients is to leverage a robust portfolio that includes differentiated approaches, particularly in tissue types and tumor types. Despite some may characterize the program as conservative, the company believes in the potential of their first-in-class and differentiated assets, including 16 phase 3 studies and various approaches to non-small cell lung cancer and breast cancer.

A：The intellectual property for Keytruda consists of four patents, with the compound patent expiring in December 2028, and two method of making and method of use patents extending to May 2029 and November 2029, respectively. Initially, the company was conservative in its assumptions, based solely on the compound patent. However, the case law has evolved, and confidence in defending the additional two patents has grown, which impacts the timing and model for Keytruda IV biosimilar induction.

A：The projected adoption for the Q product by 2028 is 30% to 40%, and the strategy to drive this adoption is already underway, focusing on transitioning from contri to IV to Cli.

A：There is a potential for a different regimen due to the need for different options in HIV treatment, as evidenced by the two-drug approach already available. A dual regimen could be significant for patients, especially in light of long-standing treatment issues with HIV, offering a two-drug combination without a density backbone.

A：The company expects significant growth, with a potential value of over $70 billion by 2027. This would be more than double the consensus estimate for CDA at $28-35 billion and is driven by a broad and light pipeline. The company believes it has the highest potential for sustainable growth close to the launch of the new product, and the de-risking of the early-stage pipeline is expected to continue through to 2027.

A：Ongoing discussions with the FDA are focusing on potential endpoints for the Phase 3 clinical trials, which will involve considerations such as functional activity, clinical events, and biomarkers. The discussions are particularly focused on aligning with the FDA for the new patient population the drug will target.

A：The company recognizes the importance and potential speed of pursuing combinations following new data, especially given the focus on Atlas and the competitive landscape. They acknowledge the shift towards various combinations and the intensification of efforts with multi-specifics. The company's mission is to be first and best in class for TL 1A, and they are studying it in six diseases, with plans to assess patient populations and discuss combinatorial potential in terms of antibodies and orals, although specific details were not disclosed in the public call.

A：Wind Rivers is reshaping the standard of care in P by targeting the underlying biology through genetics, differentiating it from classic vasal dilators. Its impact on right heart failure and PH is compared to how Merck's Ace inhibitors influenced left heart failure. Future guidelines are expected to be shaped by clinical data regarding adverse effects and long-term treatment.

A：Sites in Texas are quite bullish on Wind Rivers, discussing its benefits in terms of cardiac remodeling and sustainability. However, considerations are being given to the use of the drug in patients with connective tissue disorders, who also have conditions related to pulmonary fibrosis and other pulmonary diseases. These considerations are part of ongoing discussions and future data will guide decision-making for the drug's application.

A：To date, over 110,000 prescriptions for Wind Rivers have been dispensed, with more than 9,100 patients starting therapy. Overall compliance is high, although there is a slow increasing rate of discontinuation, which is still within acceptable limits and better than other BH products. The safety profile continues to be very confident and consistent with the label, as observed across various studies and data.

A：The company's approach to business development is focused on opportunities that show significant scientific advancement, address unmet needs aligned with strategy, and create value. They aim to maintain discipline by continuing to do deals with the same methods and approach, even for larger potential acquisitions, as illustrated by their track record.

A：m.K. 3000 is a new mechanism targeting the genetics of vascular stability in the eye, which is the first agonistic antibody towards this pathway. It is being studied for its potential in treating DME and AMD, which are important indications driven by non-vascular endothelial growth factor. Up to 40% of patients have suboptimal response to VEGF therapy, presenting an opportunity for m.K. 3000 to address this segment. m.K. 3000 could also complement VEGF therapy in the treatment regimen. In the U.S., the potential market for these indications, excluding VEGF therapy, is estimated to be around $15 billion. The addition of m.K. 748, a novel bispecific antibody, is seen as enhancing the market potential to more than $5 billion.

A：The company believes that Sac BT has the potential to be best in class, but it's crucial to determine the appropriate tumor types and strategies within those types. The need for a biomarker will vary by tumor type and is dependent on context, including the presence of strong comparators and the bar to beat in treatment. Specific details of the updated biomarker strategy are not provided, but the focus will be on the relevance of biomarkers in the treatment context and their necessity in certain tumor types.