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    Carter Gould • Cantor Fitzgerald

    Carter Gould's questions to Gilead Sciences Inc (GILD) leadership

    Carter Gould's questions to Gilead Sciences Inc (GILD) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald questioned Gilead's confidence in the approvability of anitocel (aneta-cel) based on a single-arm study, considering the evolving competitive and regulatory landscape at the FDA's CBER.

    Answer

    Chief Commercial Officer Johanna Mercier gave a concise response, stating that Gilead does not comment on its specific regulatory strategy. She confirmed that the company is in ongoing conversations with the FDA and reiterated their expectation to launch the therapy in 2026, indicating no major shifts from previously communicated plans.

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    Carter Gould's questions to Gilead Sciences Inc (GILD) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald questioned Gilead's confidence in securing approval for anetacel based on a single-arm study, considering the evolving multiple myeloma landscape and regulatory environment at the FDA.

    Answer

    Chief Commercial Officer Johanna Mercier gave a brief response, stating that Gilead does not comment on its regulatory strategy but continues to have productive conversations with the FDA. She reiterated the company's expectation for a 2026 launch and confirmed there have been no major shifts in its previously communicated plans.

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    Carter Gould's questions to Gilead Sciences Inc (GILD) leadership • Q1 2025

    Question

    Carter Gould inquired about potential disruptions to the lenacapavir launch from recent budget cuts at HHS and the CDC, and whether Gilead could step in to mitigate any impact on education and awareness.

    Answer

    CEO Daniel O'Day confirmed that Gilead has not seen any impact that would alter its launch plans and is actively engaging with policymakers. Chief Commercial Officer Johanna Mercier added that Gilead's own market development initiatives have contributed to strong PrEP market growth (16% YoY). Chief Medical Officer Dietmar Berger affirmed that interactions with the FDA remain on track for the June 19 decision.

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    Carter Gould's questions to Gilead Sciences Inc (GILD) leadership • Q3 2024

    Question

    Carter L. Gould of Barclays asked for clarity on what investors should expect from the upcoming HIV analyst event, specifically whether Gilead would provide an explicit peak sales target for lenacapavir in PrEP or more qualitative market color.

    Answer

    Daniel O'Day, Chairman and CEO, stated that the event will provide both qualitative and quantitative details on the lenacapavir for PrEP commercialization plan, but specific peak sales guidance would likely come with the 2025 outlook. He emphasized the event will also feature new disclosures and updates on the progress and timelines for Gilead's long-acting HIV treatment combinations, reinforcing the long-term durability of the franchise.

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    Carter Gould's questions to Amgen Inc (AMGN) leadership

    Carter Gould's questions to Amgen Inc (AMGN) leadership • Q2 2025

    Question

    Carter Gould asked about Amgen's stance and actions regarding the unlawful compounding of GLP-1 drugs and whether this is viewed as a potential threat to the future launch of Meritide.

    Answer

    Robert Bradway, Chairman & CEO, clarified that compounding is less of a direct issue as Meritide is a monoclonal antibody, which cannot be compounded like peptides. Murdo Gordon, EVP of Global Commercial Operations, reinforced that there is no compounding pathway for a biologic like Meritide.

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    Carter Gould's questions to Pfizer Inc (PFE) leadership

    Carter Gould's questions to Pfizer Inc (PFE) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald asked about the possibility of a comprehensive policy deal with the administration and questioned if Vyndaqel's muted sequential growth indicates that its U.S. growth phase is over.

    Answer

    Chairman & CEO Albert Bourla confirmed policy discussions include PBM reform and 340B but gave no prediction on a deal. EVP & Chief U.S. Commercial Officer Aamir Malik noted strong YoY U.S. growth for Vyndaqel but expects future sequential growth to be pressured by gross-to-net dynamics. EVP & Chief International Commercial Officer Alexandre de Germay highlighted very strong 32% international growth for the brand.

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    Carter Gould's questions to Pfizer Inc (PFE) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald & Co. asked about the possibility of a comprehensive policy deal covering MFN, tariffs, and industry concerns, and questioned if Vyndaqel's U.S. growth has peaked due to muted sequential performance.

    Answer

    CEO Albert Bourla confirmed that discussions with the administration include broader topics like PBM reform and 340B. EVP & Chief U.S. Commercial Officer Aamir Malik noted strong 15% YoY U.S. growth for Vyndaqel but acknowledged future sequential growth will face pressure from GTN and competition. EVP & Chief International Commercial Officer Alexandre de Germay highlighted strong 32% international growth, driven by new market access.

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    Carter Gould's questions to Regeneron Pharmaceuticals Inc (REGN) leadership

    Carter Gould's questions to Regeneron Pharmaceuticals Inc (REGN) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald inquired about the patient assistance matching program with the Good Days foundation, asking if any funds have been delivered and if it's expected to be a tailwind in the second half of the year.

    Answer

    President & CEO Dr. Leonard Schleifer responded that it was too early to provide useful information as the program had only been in place for a month. He added that Regeneron is monitoring the situation closely and hopes its contribution will encourage others to donate.

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    Carter Gould's questions to Regeneron Pharmaceuticals Inc (REGN) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald inquired about the progress of the patient assistance matching program with the Good Days foundation, asking if any funds had been delivered and if it could become a commercial tailwind.

    Answer

    President & CEO Dr. Leonard Schleifer responded that it was too early to provide meaningful data as the program had only been active for a month. He stated that while they hope their contribution stimulates others, they have nothing significant to report yet and will monitor the situation.

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    Carter Gould's questions to Regeneron Pharmaceuticals Inc (REGN) leadership • Q1 2025

    Question

    Carter Gould of Cantor Fitzgerald highlighted the recent series of regulatory setbacks, asking if management acknowledges an unsatisfactory performance and what steps are being taken to improve regulatory execution.

    Answer

    President and CEO Dr. Leonard Schleifer took personal responsibility while defending his regulatory and manufacturing teams. He attributed the issues to heightened FDA scrutiny of third-party contract manufacturers post-COVID, a factor that affects Regeneron more due to its high volume of submissions. While acknowledging unhappiness with the delays, he framed them as part of a broader industry challenge.

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    Carter Gould's questions to AbbVie Inc (ABBV) leadership

    Carter Gould's questions to AbbVie Inc (ABBV) leadership • Q2 2025

    Question

    Carter Gould of Cantor Fitzgerald asked for clarification on the drivers behind the raised guidance for VYLEV (referred to as BIOLEV), specifically whether it was driven by U.S. or international performance.

    Answer

    EVP & Chief Commercial Officer Jeffrey Stewart clarified that the guidance increase for VYLEV was primarily driven by very strong demand and uptake in international markets. He added that the U.S. launch remains on track, with a Medicare ramp expected in the latter half of the year.

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    Carter Gould's questions to AbbVie Inc (ABBV) leadership • Q1 2025

    Question

    Carter Gould of Cantor Fitzgerald asked about AbbVie's expectations regarding potential drug pricing changes like 'most favored nation' and the commercial strategy for the co-administration of BoNT/E and Botox, questioning its potential to grow the market or shift share.

    Answer

    CEO Robert Michael stated that while AbbVie supports policies that value innovation, international reference pricing could harm the U.S. healthcare industry. He emphasized the positive impact of the 2017 tax reform on U.S. investment. CCO Jeffrey Stewart explained that BoNT/E is expected to stimulate the market by attracting new users, while a co-formulated product could be a 'share play,' potentially creating a premium, immediate-acting Botox that could 'restate the whole market.'

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    Carter Gould's questions to Bristol-Myers Squibb Co (BMY) leadership

    Carter Gould's questions to Bristol-Myers Squibb Co (BMY) leadership • Q2 2025

    Question

    Carter Gould of Barclays asked for CEO Chris Boerner's perspective on the policy environment, specifically regarding threats to intellectual property from sources like drug compounding, and what actions BMY is taking in response.

    Answer

    CEO Chris Boerner affirmed that protecting intellectual property is critical to the innovation ecosystem and is under pressure. He stated that BMY has a strong internal IP team that also takes a leadership role in industry-wide advocacy efforts through trade organizations like BIO and PhRMA to maintain a strong IP environment.

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    Carter Gould's questions to Bristol-Myers Squibb Co (BMY) leadership • Q1 2025

    Question

    Carter Gould asked whether exogenous events, such as uncertainty around tariffs, the FDA, or drug pricing, are acting as a 'stage gate' or a holdup for executing on business development deals.

    Answer

    CEO Christopher Boerner asserted that such exogenous factors are not a constraint on business development. He emphasized that the company's strong financial position, resulting from solid execution and cost efficiency, is the more important factor, giving BMS the flexibility to act decisively on opportunities that meet its strategic and financial criteria.

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    Carter Gould's questions to Bristol-Myers Squibb Co (BMY) leadership • Q3 2024

    Question

    Carter L. Gould followed up on milvexian, asking if the increased patient enrollment would lead to any changes in the trial's enrollment criteria or patient enrichment strategy.

    Answer

    Head of Global Drug Development Samit Hirawat provided a direct answer, stating there are no plans to change any of the enrollment criteria. He confirmed the study will proceed as designed, with the only change being the increased sample size.

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    Carter Gould's questions to Eli Lilly and Co (LLY) leadership

    Carter Gould's questions to Eli Lilly and Co (LLY) leadership • Q1 2025

    Question

    Carter Gould noted the upfront commentary on tariffs and asked about other policy risks, specifically whether potential Most Favored Nation (MFN) drug pricing legislation is a priority or possibility in the near term.

    Answer

    CEO David Ricks acknowledged MFN is always a risk but argued it's an incoherent discussion without also addressing PBM reform, 340B, and the real net prices in the U.S. versus Europe. He stated the industry's current hyper-focus is on fixing the small molecule penalty within the Inflation Reduction Act (IRA). He emphasized the real long-term answer is trade negotiations that make developed economies pay more for R&D, not simply importing foreign price controls.

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