Courtney Breen • AllianceBernstein

Answer

Chief Commercial Officer Johanna Mercier provided two key reasons for maintaining the current guidance. First, she stressed that it is still very early, with the launch being only six weeks old. Second, and more critically, broad payer access needs to be secured. While the team is successfully managing one-off medical exceptions, she stated they need to see the number of covered lives increase more formally over the next one to two quarters to ensure sustained momentum and justify a guidance revision.

Ask Fintool Equity Research AI

Answer

Chief Commercial Officer Johanna Mercier responded that while the launch is strong, it is still very early at only six weeks post-approval. She explained that the critical variable is converting initial interest into broad, covered access. Until the company sees a significant increase in the number of covered lives over the next one to two quarters, it is premature to update revenue expectations.

Ask Fintool Equity Research AI

Answer

Chief Medical Officer Dietmar Berger acknowledged the question was insightful and confirmed that Gilead is currently evaluating different study designs for the once-yearly formulation. He stated that a PK-based approach is a possibility that is being discussed, but did not commit to a specific regulatory pathway at this time.

Ask Fintool Equity Research AI

Answer

CMO Dietmar Berger highlighted the impressive Phase II data for Trodelvy (TROP2) in SCLC and its Breakthrough Therapy designation. He positioned TROP2 as a potential foundational therapy in the second-line setting, while noting that other targets like DLL3 are interesting and that data for B7-H3 has been mixed.

Ask Fintool Equity Research AI

Answer

Dr. Daniel Skovronsky, Chief Scientific Officer, explained that the side effect profiles were consistent with historical data for a GLP-1 monotherapy in their respective patient populations. He noted that while dual agonists like tirzepatide offer superior results, the orforglipron profile is likely 'as good as it gets' for a once-daily oral GLP-1 monotherapy.

Ask Fintool Equity Research AI

Answer

Patrik Jonsson, President of Cardiometabolic Health, stated he could not share a specific number of lives but emphasized that the change applies to a subset of CVS plans, not the entire account. He added that the employer opt-in rate for obesity coverage within that specific subset is believed to be on the lower end, suggesting the impact may be more contained than perceived.

Ask Fintool Equity Research AI

Answer

Executive Daniel Skovronsky noted that efficacy expectations are benchmarked against single GLP-1s like Ozempic, not dual-acting tirzepatide. Executive Patrik Jonsson added that its oral formulation targets patients with needle aversion and offers an opportunity to scale in ex-U.S. markets.

Ask Fintool Equity Research AI

Answer

Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA, agreed that orforglipron is a significant market expansion opportunity due to its oral formulation. He framed the ATTAIN MAINTAIN trial as a way to understand how to best maintain patients on chronic therapy, viewing it as an alternative to improve long-term outcomes rather than a direct switching strategy from injectables.

Ask Fintool Equity Research AI

Answer

President Stephen Hoge explained it's conceivable a patient could receive INT twice, as the therapy is re-individualized based on the tumor's current neoantigens. CEO Stéphane Bancel specified that headcount reductions were focused on manufacturing, R&D (as large trials wind down), and G&A, driven by productivity gains, while hiring continues in strategic growth areas.

Ask Fintool Equity Research AI

Answer

CFO Jamey Mock explained that the cost reductions are primarily a result of the planned wind-down of several large Phase III trials by 2027. He stressed the focus on controllable costs to achieve the 2028 breakeven target. The savings will come from trial completions, procurement efficiencies, and the implementation of digital tools.

Ask Fintool Equity Research AI

Answer

CFO Jamey Mock acknowledged that 2024's $600 million in write-downs and unutilized capacity was 'not what good looks like.' He stated the company is improving by reducing raw material inventory and optimizing its manufacturing footprint, citing a recent contract termination. The long-term goal is for these costs to be less than 10% of sales.

Ask Fintool Equity Research AI

Answer

President Stephen Hoge explained the trial design reflects the evolving standard of care towards neoadjuvant KEYTRUDA, aiming to show benefit in patients who don't achieve a pathologic complete response. He stated that program expansion is paced by a disciplined approach to starting large studies and is not primarily limited by manufacturing capacity, with more Phase 3 programs planned.

Ask Fintool Equity Research AI

Answer

James Bradner, EVP of R&D, explained the design optimizes tolerability and efficacy for the monoclonal antibody. He noted the trial will provide a graded understanding of dose-response, which will guide physicians and patients in selecting optimal long-term maintenance therapy.

Ask Fintool Equity Research AI

Answer

Murdo Gordon, EVP of Global Commercial Operations, emphasized Repatha's strong momentum, driven by improved prescriber perception of access and affordability. He noted that Repatha is positioned to compete based on its proven ability to reduce hard cardiovascular events, not just lower LDL, setting a high bar for new entrants.

Ask Fintool Equity Research AI

Answer

EVP of Rare Disease Vikram Karnani explained that the 8% YoY growth is being supplemented by a new strategy to reach low CAS patients. This involves a reorganized and expanded field force, split into two dedicated teams, which was implemented in Q3. He expects this new focus to gain traction over the next several quarters and also highlighted the upcoming launch in Japan in early 2025.

Ask Fintool Equity Research AI

Answer

EVP & Chief International Commercial Officer Alexandre de Germay and EVP & Chief U.S. Commercial Officer Aamir Malik detailed efficiency gains from focusing on key markets and brands, consolidating agency partners, and leveraging technology. CEO Albert Bourla confirmed continued interest in obesity and other key areas for M&A, noting a disciplined approach to capital deployment.

Ask Fintool Equity Research AI

Answer

EVP & Chief International Commercial Officer Alexandre de Germay and EVP & Chief U.S. Commercial Officer Aamir Malik detailed efficiency strategies, including focusing on key international markets and leveraging technology in the U.S. Chairman & CEO Albert Bourla confirmed M&A interest in obesity and I&I, noting a large number of opportunities but stressing a disciplined approach to capital deployment.

Ask Fintool Equity Research AI

Answer

CEO Albert Bourla confirmed that Pfizer has taken necessary mitigation steps, including building up inventory within the U.S. Chief Scientific Officer Chris Boshoff stated that a full R&D Day is not planned, but the company will continue to use targeted 'flash events' to provide deep dives on specific pipeline areas, such as an upcoming event on breast cancer.

Ask Fintool Equity Research AI

Answer

Executive Chris Boshoff confirmed the new structure mirrors the successful end-to-end models in oncology and vaccines. Executive Andrew Baum explained that prioritization is driven by bringing a commercial lens to the process much earlier to ensure financial value. CEO Albert Bourla added that the focus is on better selecting which high-potential products to advance.

Ask Fintool Equity Research AI

Answer

EVP and Chief Oncology Officer Chris Boshoff countered this perception by detailing significant upcoming activity, including multiple Phase III readouts and new trial starts. Chief Scientific Officer Mikael Dolsten added that across the entire pipeline, there are up to 40 opportunities for approvals, pivotal readouts, or proof-of-concept data expected over the next 18 months, indicating a full slate of activity.

Ask Fintool Equity Research AI

Answer

CEO Chris Boerner explained the program aims to reduce patient out-of-pocket costs and increase transparency by 'cutting out the middleman,' aligning with administration goals. EVP & Chief Commercialization Officer Adam Lenkowsky provided details, noting the program offers over a 50% discount to list price for uninsured patients. Boerner confirmed they will explore similar opportunities for other products.

Ask Fintool Equity Research AI

Answer

CEO Christopher Boerner stated that BMS is a significantly U.S.-based company and has been consistently investing in domestic infrastructure with plans to continue. He clarified that business development is approached as a distinct activity, not dependent on the sequence of internal trial results, and that the company is now unconstrained and ready to execute on deals that fit its strategic and financial criteria.

Ask Fintool Equity Research AI

Answer

CEO Christopher Boerner reiterated that BD is a top priority focused on strengthening core therapeutic areas, supported by a strong financial position. CCO Adam Lenkowsky explained that Cobenfy's gross-to-net will be heavily weighted towards public payers like Medicare and Medicaid, which cover the vast majority of patients in schizophrenia and future Alzheimer's indications, with commercial payers representing less than 10% of the business.

Ask Fintool Equity Research AI

Answer

Chief Commercialization Officer Adam Lenkowsky stated the label is very positive as it avoids the major side effects that lead to discontinuation. He explained that the recommended lab monitoring is not mandated and is common practice for this patient population, so it is not expected to be a barrier to adoption. Samit Hirawat added that long-term safety data reinforces this confident profile.

Ask Fintool Equity Research AI

Answer

Chairman & CEO Robert Davis clarified that the goal is to broaden Merck's leadership in oncology beyond just KEYTRUDA. He explained that spending will be reallocated and increased for the broader oncology portfolio, including antibody-drug conjugates and small molecules, as the company moves away from being solely focused on KEYTRUDA.

Ask Fintool Equity Research AI

Answer

Chairman & CEO Robert Davis explained the strategy is to broaden leadership in oncology beyond KEYTRUDA. He stated that spending will be reallocated and increased to support the wider oncology portfolio, with spend on other oncology assets growing as KEYTRUDA-specific spend is reduced.

Ask Fintool Equity Research AI

Answer

CFO Caroline Litchfield clarified that since the GARDASIL inventory is owned by their partner Zhifei, the risk of a write-off for Merck is 'extremely low.' Regarding the Part D redesign, she explained that the $400 million negative impact is predominantly a pricing impact, which will be partially offset by some volume benefit as patients stay on therapy longer.

Ask Fintool Equity Research AI

Answer

CEO Robert Michael declined to speculate on the impact of tariffs absent specific policy details, stating the company would be transparent once details are known. CCO Jeffrey Stewart noted that the pricing for BoNT/E is premature but will be determined closer to launch. He suggested that while a shorter duration might imply a lower price, the value it brings to practices by attracting new patients with high lifetime value would be a key consideration.

Ask Fintool Equity Research AI