Carter L. Gould

Carter Gould asked about the regulatory flexibility on individual serotypes, specifically regarding serotype 3 comparisons against PCV21 (Capvaxive), given its importance in IPD prevalence and commercial implications.

Answer

Grant Pickering, CEO of Vaxcyte, reiterated that FDA approval is based on the 'totality of the vaccine's contribution,' and missing a few serotypes would not be a disqualifier. He acknowledged serotype 3 as an outlier, noting that no current vaccine has produced protective antibody responses, and it has not been a competitive differentiator. Pickering added that Vaxcyte's serotype 3 responses looked better than Prevnar 20 in previous studies.

Carter Gould asked about the extent of regulatory flexibility on individual serotypes in OPUS-1, specifically regarding serotype 3 comparisons against PCV21, and the commercial importance of demonstrating non-inferiority for this serotype.

Answer

Grant Pickering, CEO of Vaxcyte, reiterated that the FDA has indicated flexibility, stating that missing on a few serotypes would not be a disqualifier. He highlighted serotype 3 as an outlier in the pneumococcal space, noting that no vaccine has produced antibody responses sufficient to control it, and thus it has not been a competitive differentiator despite some products showing statistically higher responses.

Carter Gould inquired about Merck's strategy for pursuing combinations with its TL1A inhibitor, Tulisokibart, especially in light of competitors' rapid advancements with IL-23 combinations and multi-specifics, while acknowledging the near-term focus on Atlas UC.

Answer

Dean Li, President of Research Labs, positioned TL1A as a potential third class in immunology, aiming for Tulisokibart to be first and best-in-class. He confirmed that while the immediate focus is on ulcerative colitis and Crohn's disease, Merck has a robust plan for future combinability strategies, including two separate antibodies, bispecifics, and orals, but declined to elaborate further on public call.

Carter Gould inquired about Merck's strategy for its TL1A inhibitor, Tulisokibart, beyond the near-term focus on ulcerative colitis, specifically how Merck plans to pursue combinations and at what speed, given intensified efforts by entrenched IL-23 players in multi-specifics and partnerships.

Answer

Dean Li, President of Research Laboratories, Merck & Co. Inc, positioned TL1A as a potential third class in immunology, with Merck aiming to be first and best-in-class. He confirmed the near-term focus on ulcerative colitis and Crohn's disease data. He acknowledged that successful data would lead to discussions about patient populations, other diseases, and combinability (two separate antibodies, bispecifics, or orals), assuring that Merck has a robust plan for future development beyond initial monotherapy.

Carter L. Gould from Barclays asked about WINREVAIR's performance, specifically the impact of channel stocking in the quarter and how far Merck has progressed in treating the initial bolus of the sickest patients.

Answer

CFO Caroline Litchfield clarified that over 80% of WINREVAIR revenue was driven by demand, with minimal inventory build. She noted that approximately 80% of patients are on background triple therapy, indicating strong progress in the sickest patient segment. She also mentioned that physicians are beginning to prescribe to patients on dual therapy, signaling expansion into a broader patient population.

Carter Gould asked for clarification on ADEPT 2 timelines, specifically addressing discussions around potentially adding patients to under-enrolled sites and whether more patients have been added since enrollment completion, to explain any variance between implied and actual data timelines.

Answer

Chris Boerner, Board Chair and CEO, reiterated that ADEPT 2 results are expected by the end of the year and declined to provide additional specifics, emphasizing that the turning of the card is very close. He reaffirmed confidence in the overall Cabenfi program, citing compelling external data, positive performance feedback in schizophrenia, and internal data. Cristian Massacesi, Chief Medical Officer and Head of Global Drug Development, clarified that ADEPT 1:1 is a relapse prevention design, an ongoing study, and data on the leading phase will be shared when the full study data is released.

Carter Gould asked for clarification on the ADEPT 2 study, specifically addressing discussions around potentially adding patients to under-enrolled sites and whether more patients have been added since enrollment completion, and if this could explain any variance between implied timelines and actual data timelines.

Answer

CEO Chris Boerner reiterated that the ADEPT 2 study results are expected by the end of the year and will be communicated when available, noting that the readout is very close. He did not provide further specifics on enrollment or site management.

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.

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.

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.

Carter Gould asked about the low matching contributions to the Good Days Retinal Vascular and Neovascular Disease Fund and whether Regeneron would consider a different approach next year if other contributors do not match their commitment.

Answer

President and CEO Leonard Schleifer stated that Regeneron will look at the situation fresh next year to determine the best strategy to help patients, implying they would re-evaluate their approach if matching contributions remain low.

Carter Gould from Cantor asked about the future of Regeneron's matching program for the Good Days Retinal Vascular and Neovascular Disease Fund beyond the end of the year, given the meager matching contributions from other parties thus far.

Answer

Regeneron President and CEO, Leonard Schleifer, stated that the company will look at the situation fresh next year to determine the best strategy to help patients, without wanting to discourage future commitments from other potential contributors.

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.

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.

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.

Carter L. Gould of Barclays asked if the market entry of an EYLEA biosimilar has altered Regeneron's strategy regarding the pace of R&D investments or its capital allocation priorities like buybacks and dividends.

Answer

President and CEO Dr. Leonard Schleifer stated that the company's strategy is to invest in innovation, not imitation, and spending will be based on opportunities, not gated by biosimilar entry. He highlighted the pipeline of over 40 clinical programs and the strength of the balance sheet. He affirmed the company would continue to invest in its R&D organization and expects investments to increase, viewing this as the key to long-term value.

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.

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.

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.

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.

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.

Carter L. Gould inquired about the launch of PABlu, a biosimilar to EYLEA, asking about the expected adoption rate before a permanent Q code is issued and payer expectations regarding step-edits.

Answer

EVP of Global Commercial Operations Murdo Gordon stated that being in the first wave of launches is important and that Amgen expects strong early interest, even with a temporary reimbursement code. CEO Robert Bradway added that the overall biosimilar franchise is performing well and generating attractive returns for shareholders.

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.

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.

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.

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.'

Carter L. Gould of Barclays inquired about the differentiated aspects of the Aliata acquisition's brain delivery technology and the broader strategic importance of Alzheimer's disease in AbbVie's neuroscience portfolio.

Answer

CSO Roopal Thakkar highlighted Aliata's potential for higher CSF concentrations and an extended half-life, enabling convenient subcutaneous dosing and potentially better efficacy and safety. CEO Robert Michael framed the deal as a key long-term investment in neurodegeneration, one of four main segments of their growing neuroscience franchise.

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.

Carter L. Gould from Barclays asked about the impact of inventory in the quarter, whether patient start numbers would be provided, and what the initial broad but not deep prescribing pattern implies about physician adoption.

Answer

EVP & CCO Jim Ziegler confirmed inventory levels are within the normal 2-4 week range for a buy-and-bill product. He stated Geron will not provide patient start numbers due to the metric's unreliability. He agreed that early launch shows breadth first, with prescribing depth expected to build over time, consistent with the company's expectation of steady growth rather than a large initial bolus.

Carter Gould from Barclays noted the pipeline's evolution to a 'barbell' structure and asked about the strategy for replenishing the early-stage portfolio beyond the current focus on VMAT and muscarinic assets.

Answer

CEO Kyle Gano highlighted that the early-to-mid-stage pipeline is broader than it appears, including a muscarinic antagonist for movement disorders and an NR2B NAM in Phase II for MDD. He stated that more information on emerging preclinical assets moving into the clinic would be shared in early 2025, noting significant productivity in the company's labs.

Sought clarification on the latozinemab regulatory strategy, whether the biomarker approach is a contingency plan, and asked about the path forward for INVOKE-2 post-data and any read-through from AbbVie discontinuing its A-beta program.

Answer

The latozinemab biomarker strategy is not a contingency but a way to strengthen the data package for a full approval, given it's a single study in a rare disease. The path forward for AL002 (INVOKE-2) is subject to AbbVie's opt-in decision. The company does not see a direct read-through from AbbVie's A-beta program discontinuation to their interest in AL002, which has a different mechanism.

Carter L. Gould of Barclays sought clarity on the latozinemab regulatory strategy, asking if using biomarkers as 'confirmatory evidence' is a contingency plan. He also asked about the timing of the path forward decision for INVOKE-2 and the potential read-through from AbbVie discontinuing its own A-beta program.

Answer

Dr. Gary Romano, CMO, asserted the biomarker strategy for latozinemab is not a contingency but a way to strengthen the data package for full approval in a rare disease. Dr. Marc Grasso, CFO, added that there is no direct read-through from AbbVie's decision, as AL002's broad mechanism is distinct from an A-beta-only approach, and that Alector remains aligned with AbbVie on the Phase II data package.