Alexandria Hammond

Alexandria Hammond asked for an update on the TRAILBLAZER-ALZ 3 study, specifically regarding the accrual of progression events and a reminder of what would constitute a successful trial outcome.

Answer

Anne White, President of Lilly Neuroscience, confirmed that the trial is event-based and the readout timing depends on event accrual, which could be earlier than the 2027 date on clinicaltrials.gov. She explained the goal is to significantly reduce the risk of people with elevated amyloid from ever experiencing symptoms of Alzheimer's. The primary endpoint is time to clinical progression, measured by the CDR global score, with success defined as preventing the move to the symptomatic stage.

Alexandria Hammond of Wolfe Research asked how the partnership with Ro is envisioned to evolve and requested framing the opportunity for step-down vials.

Answer

Executive Patrik Jonsson explained the Ro partnership is a non-financial platform to help patients access authentic medicine via LillyDirect, with similar partnerships to follow. He noted step-down vials are in the low teens for new therapy starts, indicating strong initial uptake.

Alexandria Hammond from Wolfe Research inquired about Regeneron's confidence in the fianlimab + Libtayo combination outperforming Opdualag and achieving a statistically significant benefit against Keytruda in metastatic melanoma, and sought more details on the ongoing open-label Phase III trial against Opdualag.

Answer

Regeneron President and CEO, Leonard Schleifer, explained that the ongoing study compares their combination against Keytruda, with the hope that at least one of their two dose arms will perform better. He noted the study is powered to achieve Opdualag-like activity in PFS and to win in OS, where Opdualag failed. He expressed excitement for the program, citing high unmet need and promising earlier trial data, with results anticipated in the first half of next year.

Alexandria Hammond asked about Regeneron's confidence in the upcoming LIBTAYO LAG-3 readout outperforming Opdualag and demonstrating a statistically significant benefit against KEYTRUDA, and for details on the open-label Phase III trial against Opdualag.

Answer

President and CEO Leonard Schleifer stated that their study is ongoing, comparing their combination against KEYTRUDA, with the hope that at least one of their two arms (low/high dose) will perform better. He explained the study is powered to achieve PFS and OS benefits, with a minimal expectation of Opdualag-like activity but designed to win on OS where Opdualag failed. He reiterated excitement for the program and the high unmet need.

Alexandria Hammond of Wolfe Research asked about the upcoming pozetelimab readout in generalized myasthenia gravis (gMG), inquiring about the bar for both clinical and commercial success.

Answer

President & CSO Dr. George Yancopoulos stated the clinical goal is to show efficacy similar to existing agents but with a more convenient monthly subcutaneous dosing regimen. EVP of Commercial Marion McCourt added that this convenience, in a large market with unmet need, would be a key commercial driver, alongside a strong safety profile.

Alexandria Hammond of Wolfe Research asked about the upcoming data for the C5 program (pozelimab) in generalized myasthenia gravis (gMG), specifically inquiring about the bar for clinical and commercial success.

Answer

President & CSO Dr. George Yancopoulos stated the clinical goal is to show efficacy similar to existing agents but with a much more convenient monthly subcutaneous dosing regimen. EVP of Commercial Marion McCourt added that in this large market with unmet need, a differentiated product offering convenience with a good safety profile would be commercially important.

Alexandria Hammond of Wolfe Research asked about the Factor XI antibody program, specifically how Regeneron is prioritizing indications, the anticipated launch timing, and any updates on regulatory discussions regarding trial design.

Answer

An executive, likely CSO Dr. George Yancopoulos, stated that the company is pursuing a mix of longer-term indications and undisclosed ones with a potentially faster path to market. The priority is on studies demonstrating both anticoagulation benefits and a superior, lower bleeding risk profile. It was confirmed that pivotal Phase III studies are set to begin enrollment in 2025.

Alexandria Hammond inquired about the evolving regulatory landscape for biosimilars, including the feasibility of using PK comparability instead of Phase 3 trials, and the potential impact on Amgen's long-term sales guidance.

Answer

James Bradner, EVP of R&D, noted that a potential softening of requirements would play to Amgen's strengths. Murdo Gordon, EVP of Global Commercial Operations, emphasized it remains a technically difficult field. Robert Bradway, Chairman & CEO, concluded the market is developing as expected.

Alexandria Hammond of Wolfe Research asked about the future market dynamics for rocatinlumab in atopic dermatitis, questioning if management anticipates an even split with key competitors.

Answer

Murdo Gordon, EVP of Global Commercial Operations, stated that Amgen sees a significant opportunity for rocatinlumab, given the large refractory patient population in atopic dermatitis. However, he declined to speculate on a specific future market share split against other agents that are also still in development, but reiterated confidence in the drug's potential.

Alexandria Hammond asked about Amgen's strategy for sourcing innovation from China and its general appetite for M&A following the large Horizon acquisition.

Answer

CEO Robert Bradway reiterated a consistent business development strategy, stating the company is actively searching for value-adding molecules globally, including in China. He confirmed that Amgen remains 'open for business' for both licensing and acquisition opportunities.

Alexandria Hammond of Wolfe Research, LLC questioned how the recently announced direct-to-consumer purchasing option for Eliquis could be applied to the rest of Pfizer's product portfolio.

Answer

CEO Albert Bourla responded that the direct-to-consumer model is a 'fantastic way to go' and aligns with requests from the administration. He noted Pfizer has experience with its 'Pfizer for all' website and the new 'Eliquis 360' program, and that the broader industry is ready to execute similar initiatives.

Alexandria Hammond of Wolfe Research, LLC questioned how the recently announced direct-to-consumer purchasing option for Eliquis could be applied to the rest of Pfizer's portfolio.

Answer

Chairman & CEO Albert Bourla responded that the direct-to-consumer model is a "fantastic way to go" and aligns with administration requests. He highlighted Pfizer's experience with its 'Pfizer for All' platform and the new 'Eliquis 360' program with Bristol Myers Squibb, noting broad industry support for such initiatives to improve patient access and affordability.

Alexandria Hammond asked about the near-term commercial dynamics for VYNDAQEL, given new market competition, and where the largest impact on market share might occur.

Answer

Executive Aamir Malik acknowledged that while new competition and the IRA will be headwinds, VYNDAQEL's growth will be supported by increased diagnosis rates and favorable affordability. He expressed confidence that its robust clinical profile, real-world data, and strong access will maintain its position as the standard of care.

Alexandria Hammond from Wolfe Research LLC inquired about VOXZOGO's commercial execution, asking for the current time from prescription to treatment start and for an update on the strategy to increase referrals from pediatricians.

Answer

Cristin Hubbard, EVP and Chief Commercial Officer, stated that the time from diagnosis to treatment can take months and is a key focus for reduction. She reported that the strategy to drive referrals is succeeding, contributing to Q2 growth, with strong uptake seen in the youngest patient cohorts (0-4 years) and growth coming from all prescriber types, including pediatricians, geneticists, and endocrinologists.

Alexandria Hammond of Wolfe Research asked for an update on VOXZOGO commercial efforts, specifically the average time from prescription to treatment and the progress of increasing referrals from pediatricians.

Answer

Cristin Hubbard, EVP and Chief Commercial Officer, stated that the focus is on reducing the time from diagnosis to treatment, which can take months. She highlighted strong uptake in the youngest patient cohorts (0-2 and 2-4 years old) and confirmed that the strategy of driving referrals from pediatricians to specialists is successful, with growth seen across all treater types, including pediatricians, geneticists, and endocrinologists.

Alexandria Hammond of Wolfe Research LLC asked about the strategy for enlicitide as a platform asset, inquiring about potential future combinations, additional indications, and the timing of any updates.

Answer

Dr. Dean Li, President of Merck Research Laboratories, described the ambition for enlicitide to be the best-in-class oral PCSK9 inhibitor. He outlined a combination strategy focused on deepening LDL reduction, as well as targeting other cardiovascular risk factors like Lp(a) and inflammation. He positioned enlicitide as a foundational molecule for driving significant improvements in cardiovascular outcomes.

Alexandria Hammond from Wolfe Research LLC asked about enlicitide's potential as a platform for other cardiometabolic assets, inquiring about expected combinations, indications, and the timing of future updates.

Answer

Dr. Dean Li, President of Merck Research Labs, explained the ambition for enlicitide to be a best-in-class oral PCSK9 inhibitor. He outlined its potential as a platform for combinations to deepen LDL response, as well as combinations with agents targeting Lp(a) and inflammatory pathways to further improve cardiovascular outcomes.

Alexandria Hammond of Wolfe Research inquired about the importance of a potential ACIP wording update for the HPV vaccine recommendation to include ages 9-12 for U.S. sales.

Answer

CEO Robert Davis described the potential change as a 'very important and positive development.' He explained that starting vaccination at age 9 could improve completion rates and allow for better focus on the vaccine. While not a 'big upside' since it's already approved, he said the ACIP recommendation would reinforce its importance.

Alexandria Hammond of Wolfe Research, LLC inquired about the launch strategy for TAR-200, including commercial readiness and patient penetration expectations for the bladder cancer therapy.

Answer

EVP Jennifer Taubert described TAR-200 as a product that represents the best of J&J, leveraging both Innovative Medicine and MedTech capabilities for development and training. She highlighted the large patient opportunity and confirmed that launch planning is well underway to support what the company expects to be a very successful launch, starting in BCG-failed patients before expanding.

Alexandria Hammond asked about the expected sales growth cadence for CAPLYTA following the Intracellular Therapies acquisition and whether this deal would lead to the deprioritization of other neuroscience assets like seltorexant.

Answer

Executive Jennifer Taubert stated that CAPLYTA's growth will be catalyzed by the potential approval for major depressive disorder (MDD), which is its largest potential indication. An executive, likely John Reed, affirmed that other neuroscience assets will not be deprioritized, as the company's strategy is to build a broad portfolio with unique mechanisms to treat the heterogeneous nature of depression, highlighting the benign side-effect profiles across the portfolio.

Alexandria Hammond of Wolfe Research asked about the expected timing for results from the Skyrizi and Rinvoq combination trials and which combination AbbVie is most excited about from a mechanistic standpoint.

Answer

CSO Roopal Thakkar stated that early data from the combination studies should begin reading out next year. He expressed excitement about several mechanisms, including combinations with an alpha 4 beta 7, the bispecific lutikizumab (anti-IL-1 alpha/beta), and a longer-acting TL1A antibody. CEO Robert Michael added that these combinations are part of a long-term strategy to elevate the standard of care and drive the company's 'third chapter' of growth beyond the current Skyrizi and Rinvoq indications.

Alexandria Hammond asked about the expected impact of the 340B channel mix on HIV pricing in 2025 and how utilization in that channel might compare to 2024.

Answer

Chief Commercial Officer Johanna Mercier noted that while the 340B channel has grown, they hope it will stabilize. She affirmed Gilead's support for the program's original intent but called for more transparency to reduce duplicate discounts. No new trends beyond the ongoing growth seen in 2024 were projected for 2025.

Alexandra Hammond of Wolfe Research asked management to highlight the key pipeline assets they believe will drive revenue in the latter half of the decade, referring to them as their "favorite child or two."

Answer

CEO Christopher Boerner declined to pick a favorite, citing a "wealth of opportunity." He highlighted a first wave of major assets including Cobenfy, multiple CELMoD programs (iberdomide, mezigdomide, gocotomide), Milvexian, and LPA1. He also mentioned a next wave of assets, emphasizing the numerous potential catalysts expected over the next 24 months.