James Shin

Answer

CEO Christian Itin explained that the European market access process, designed for randomized controlled trials, poses a methodological challenge for single-arm cell therapies, necessitating a disciplined, country-by-country approach to ensure economic viability. CFO Rob Dolski clarified that while the revenue recognition change itself has little impact, the administrative adjustments at centers slowed enrollment in Q2, an effect expected to resolve by Q4.

Ask Fintool Equity Research AI

Answer

CEO Christian Itin and CFO Rob Dolski clarified that Q1 revenue was recognized on the first dose, but all patients received both doses. They are evaluating the new CMS split-coding but don't expect a material full-year impact. On tariffs, Itin noted they are based on lower manufacturing costs, not list price, and blood products are often exempt. Regarding the FDA, Itin expressed confidence in their agreed-upon trial design for lupus nephritis, citing the high unmet medical need of the patient population.

Ask Fintool Equity Research AI

Answer

Christian Itin, an executive, responded that while it's too early for specifics, the company sees a 'very good dynamic' and significant interest, driven by the enthusiasm of activated centers. Regarding outpatient use, Itin acknowledged that physicians are interested in exploring it for patients with low tumor burden due to the attractive safety profile, but stated it's too early in the launch to guide on its current use, noting it will evolve as physicians gain more experience.

Ask Fintool Equity Research AI

Answer

CEO Christian Itin confirmed that the EU and UK approval timelines remain on track for mid-2025. He added that obe-cel's safety profile, particularly for patients with low disease burden, creates a significant opportunity for administration in a hospital outpatient setting as physicians gain more experience with the therapy.

Ask Fintool Equity Research AI

Answer

Alan Bash, President of CARVYKTI, described the VOA partnership as a key first milestone in penetrating community network practices. He confirmed that efforts are underway to create a 'FACT light' or 'FACT umbrella' system to ease adoption. CEO Ying Huang added that Texas has already passed legislation removing the FACT accreditation requirement for reimbursement, a trend they expect to continue.

Ask Fintool Equity Research AI

Answer

Chief Medical Officer Mythili Koneru stated they are confident in their approach for CARTITUDE-6 and plan to meet with the FDA in the next two months. Alan Bash, President of CARVYKTI, confirmed that industry discussions for a 'fact-light' accreditation are ongoing and could help unlock community opportunity.

Ask Fintool Equity Research AI

Answer

Executive Alan Bash explained that the strategy is more about leveraging affiliations, where smaller centers can operate under the FACT accreditation umbrella of a larger institution, rather than removing the requirement wholesale. Executive Jessie Yeung clarified that the ALC mitigation strategy was not incorporated into CARTITUDE-5 as it had already completed enrollment. An Unknown Executive added that based on their database, about 20% of patients could potentially reach the ALC threshold and benefit from the intervention.

Ask Fintool Equity Research AI

Answer

CMO Mythili Koneru and SVP Steven Gavel both emphasized that CARVYKTI's unique, delayed CRS onset is what makes robust outpatient administration possible. Gavel pointed to Abecma's acute CRS as the reason it has not seen significant outpatient adoption, reinforcing that this profile is a distinct clinical and commercial advantage for CARVYKTI.

Ask Fintool Equity Research AI

Answer

David Berman, EVP of R&D, noted the last interaction was last year but emphasized the trial is a randomized Phase III with an OS endpoint, unlike the single-arm trial that faced recent issues. He believes the control arm design will be sufficient. Ralph Torbay, EVP of Commercial, explained that European duration is excellent and similar to the U.S. in mature markets like Germany and France, while still maturing in newer launch countries.

Ask Fintool Equity Research AI

Answer

CEO Chris Boerner responded that the entire management team is already focused on shortening the earnings trough. He expects the new CMO, Christian Masacezi, to bring a sharp focus on execution, talent development, and accelerating the use of new technologies, while building on the strong foundation already in place.

Ask Fintool Equity Research AI

Answer

CEO Christopher Boerner emphasized that while multiple policy areas are important, competitive tax policy is critically important for encouraging U.S. R&D investment. CMO Samit Hirawat commented that the PD-1/VEGF data is evolving and will be monitored, but noted that BMS has a large, precision-driven portfolio in lung cancer and is focused on its own IO franchise.

Ask Fintool Equity Research AI

Answer

CMO Samit Hirawat stated that for the RISE trial, the focus is on the difference between arms, where even small changes are clinically meaningful. For the ADAPT trial, he explained that per standard practice, a positive result would be announced via a top-line press release, with the full data set reserved for presentation at a future medical conference.

Ask Fintool Equity Research AI

Answer

Head of Global Drug Development Samit Hirawat explained that because the trial is blinded, the company does not have access to data separated by arm. Therefore, he could not comment on specifics like treatment separation or bleed rates, reiterating that their update was based on the overall blended event rate.

Ask Fintool Equity Research AI

Answer

Dr. Dean Li, President of Merck Research Laboratories, reiterated that Merck's commitment to the space is long-standing, since 2018, and has not changed. He confirmed the program with Kelun-Biotech is moving forward as planned and declined to comment on business development notifications.

Ask Fintool Equity Research AI

Answer

Dr. Dean Li, President of Merck Research Labs, reiterated that Merck's commitment to the program is unchanged and based on its long-standing interest in the scientific space. He confirmed the program is moving forward as planned and declined to comment on business development notifications.

Ask Fintool Equity Research AI

Answer

CEO Robert Davis confirmed that U.S. investment will likely grow beyond the currently committed figures, independent of tax reform. Dr. Dean Li noted that while the field is watching PD-1/VEGF data, Merck believes it is the 'advantaged owner' for such a combination due to its KEYTRUDA expertise and portfolio, and will move with speed as data evolves.

Ask Fintool Equity Research AI

Answer

CEO Robert Davis confirmed that the U.S. market outlook for GARDASIL is unchanged and did not influence the guidance withdrawal. Dr. Dean Li, President of Merck Research Labs, addressed the ACIP meeting by distinguishing between the CDC's role and the FDA's role in setting the label, noting the FDA has a very high evidentiary bar for changing dosing schedules, which he expects the CDC will consider.

Ask Fintool Equity Research AI

Answer

An executive, likely CFO Lucas Montarce, reaffirmed the full-year guidance and confirmed that the expectation for mid- to high-single-digit price erosion remains unchanged. He noted that the Q1 price decline of 6% was consistent with this forecast and that dynamic market events like the CVS decision are factored into their ongoing forecasting process.

Ask Fintool Equity Research AI

Answer

Executive Daniel Skovronsky explained the strategy is similar to what was successfully used for tirzepatide. The goal is to mitigate GI side effects and improve tolerability while still achieving the expected plateau efficacy in longer-term studies.

Ask Fintool Equity Research AI

Answer

Executive Steven Stein highlighted the rapid drug effect, noting a 20-30% absolute improvement in HiSCR rates within six weeks for the crossover group. While confirming that about one-third of the total study population was biologic-exposed and that activity was seen across all groups, he did not provide a specific breakout for the crossover patients.

Ask Fintool Equity Research AI

Answer

Pablo Cagnoni, President, Head of R&D, stated that the povorcitinib HS data will be disclosed via a press release, likely accompanied by a conference call. Regarding axatilimab, he noted that the company is still completing its evaluation of the preclinical toxicology findings and will provide an update later in the year.

Ask Fintool Equity Research AI

Answer

Steven Stein, an executive, stated it was too early to provide precise timelines beyond what was presented. He confirmed the endpoint is HiSCR 75 as agreed with regulators and noted that while they expect the trial to enroll well due to the high unmet need, a more precise update on the endpoint timing will be provided later.

Ask Fintool Equity Research AI

Answer

CFO Scott Reents explained that for Skyrizi and Rinvoq, Q1 performance was driven by strong demand, with a slight favorable price impact due to effective co-pay management and earlier-than-expected channel mix changes. However, he reiterated the expectation for negative pricing headwinds on a full-year basis. For Humira, he confirmed the negative impact from both volume erosion and price compression from rebating dynamics in the new contract year.

Ask Fintool Equity Research AI

Answer

CSO Roopal Thakkar detailed the strategic measures Cerevel took to control for placebo response, including limiting sites, central review, and rigorous rater training. He emphasized that with a strong effect size in Phase Ib, emraclidine's highly competitive safety and tolerability profile would be a key differentiator.

Ask Fintool Equity Research AI

Answer

Chief Commercial Officer Johanna Mercier confirmed there is a positive implication. She attributed Descovy's 38% year-over-year growth to higher demand and realized price, which were driven by 16% PrEP market growth, focused commercial execution that grew Descovy's share, and improved unrestricted access. She stated these factors create a favorable environment for the lenacapavir launch.

Ask Fintool Equity Research AI

Answer

James Bradner, EVP of R&D, listed the broad focus areas for the MARITIME program, including chronic weight management, cardiovascular and kidney disease, and sleep apnea. However, he stated that it was premature to disclose specific trial designs, such as head-to-head comparisons, as discussions with regulators are ongoing.

Ask Fintool Equity Research AI

Answer

VP of Research and Development, Drew Deniger, confirmed they are looking at exhaustion markers in patient one, noting they were encouraged that T-cells were infiltrating the tumor. VP of Technical Operations, Abhi Srivastava, explained that the cryopreservation process does not significantly alter the product, with qualification runs showing similar high purity, viability, and TCR positivity compared to the fresh product.

Ask Fintool Equity Research AI