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    James Shin's questions to Legend Biotech Corp (LEGN) leadership

    James Shin's questions to Legend Biotech Corp (LEGN) leadership • Q2 2025

    Question

    James Shin asked what the Virginia Oncology Associates (VOA) partnership specifically provides for Legend, what portion of community practices are awaiting CARVYKTI slots, and if a 'lighter' FACT accreditation is the main driver for community adoption.

    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.

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    James Shin's questions to Legend Biotech Corp (LEGN) leadership • Q1 2025

    Question

    James Shin from Deutsche Bank inquired about the endpoint strategy for the CARTITUDE-6 trial, particularly the potential use of MRD, and asked about the status of an industry coalition aimed at lowering accreditation requirements for community-based CAR-T administration.

    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.

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    James Shin's questions to Legend Biotech Corp (LEGN) leadership • Q4 2024

    Question

    James Shin asked for updates on removing FACT accreditation requirements to broaden outpatient use and whether data from CARTITUDE-5 and -6 will be broken out for patients who did or did not require intervention based on ALC levels.

    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.

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    James Shin's questions to Legend Biotech Corp (LEGN) leadership • Q3 2024

    Question

    James Shin questioned how a competitor with a short CRS onset could succeed in the outpatient setting, given the challenges seen with similar products like Abecma.

    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.

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    James Shin's questions to Immunocore Holdings PLC (IMCR) leadership

    James Shin's questions to Immunocore Holdings PLC (IMCR) leadership • Q2 2025

    Question

    James Shin of Deutsche Bank asked for confirmation that ImmunoCor has recently checked in with the FDA regarding the TEBI-AM trial design and inquired how the duration of therapy for Chemtrac in Europe is trending relative to the U.S.

    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.

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    James Shin's questions to Bristol-Myers Squibb Co (BMY) leadership

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

    Question

    James Shin of Deutsche Bank asked what changes investors should expect in the early-stage pipeline and BD strategy under the incoming Chief Medical Officer, and if this could shift the company's projected earnings trough.

    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.

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

    Question

    James Shin asked what specific macro policy decision, such as tax reform or tariff rates, would be a key data point for the company's planning. He also inquired about the competitiveness of recent PD-1/VEGF combination data sets.

    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.

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    James Shin's questions to Bristol-Myers Squibb Co (BMY) leadership • Q4 2024

    Question

    James Shin of Deutsche Bank asked about the company's expectations for the PANSS score benefit in the RISE trial and how the data from the ADAPT 2 trial for Cobenfy will be disclosed.

    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.

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

    Question

    James Shin returned to the milvexian trial, asking if there was any observable separation between the treatment arms or any color on bleed rates from the blinded data.

    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.

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    James Shin's questions to Merck & Co Inc (MRK) leadership

    James Shin's questions to Merck & Co Inc (MRK) leadership • Q2 2025

    Question

    James Shin of Deutsche Bank asked if Merck was notified of Sino Biopharm's interest in its partner Kelun-Biotech (Lenovo) and if this development affects Merck's commitment to their partnered PD-1/VEGF bispecific asset.

    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.

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    James Shin's questions to Merck & Co Inc (MRK) leadership • Q2 2025

    Question

    James Shin of Deutsche Bank asked about the PD-1/VEGF bispecific (MK-2010), questioning if Merck was notified of Sino Biopharm's interest in its partner Kelun-Biotech and if this development affects Merck's commitment to the program.

    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.

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    James Shin's questions to Merck & Co Inc (MRK) leadership • Q1 2025

    Question

    James Shin of Deutsche Bank AG questioned the need for more U.S. CapEx and whether recent PD-1/VEGF data would accelerate Merck's own programs.

    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.

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    James Shin's questions to Merck & Co Inc (MRK) leadership • Q4 2024

    Question

    James Shin asked for Merck's expectations from the upcoming February 2025 ACIP meeting regarding GARDASIL dosing questions, and whether the U.S. market outlook played any role in the decision to withdraw the long-term global guidance for the vaccine.

    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.

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    James Shin's questions to Eli Lilly and Co (LLY) leadership

    James Shin's questions to Eli Lilly and Co (LLY) leadership • Q1 2025

    Question

    James Shin asked if the company's guidance for a mid- to high-single-digit price headwind for the year remains intact following the CVS formulary decision on Zepbound and recent movements in foreign exchange rates.

    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.

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    James Shin's questions to Eli Lilly and Co (LLY) leadership • Q4 2024

    Question

    James Shin of Deutsche Bank asked how the slower titration schedule in Orforglipron's Phase III trials might impact results compared to the faster titration in Phase II.

    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.

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    James Shin's questions to Incyte Corp (INCY) leadership

    James Shin's questions to Incyte Corp (INCY) leadership • Q1 2025

    Question

    James Shin asked about the week 18 povorcitinib data, specifically if placebo crossover patients experienced rapid pain reduction and if a pre- and post-biologic exposure breakout could be provided for this group.

    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.

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    James Shin's questions to Incyte Corp (INCY) leadership • Q4 2024

    Question

    James Shin from Deutsche Bank asked about the disclosure plan for the povorcitinib STOP-HS1 and 2 Phase III trial data. He also requested an update on the axatilimab (262) program for chronic spontaneous urticaria (CSU).

    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.

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    James Shin's questions to Incyte Corp (INCY) leadership • Q3 2024

    Question

    James Shin of Deutsche Bank AG asked about the ruxolitinib cream Phase III trial in hidradenitis suppurativa (HS), specifically the time point for the HiSCR 75 assessment and whether the mid-2027 approval timeline implies data would be expected in 2026.

    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.

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    James Shin's questions to AbbVie Inc (ABBV) leadership

    James Shin's questions to AbbVie Inc (ABBV) leadership • Q1 2025

    Question

    James Shin from Deutsche Bank AG asked about the current price versus volume dynamics in the immunology franchise, specifically if the previously guided low single-digit price headwind is being realized and how it is blended across Humira, Skyrizi, and Rinvoq.

    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.

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    James Shin's questions to AbbVie Inc (ABBV) leadership • Q3 2024

    Question

    James Shin from Deutsche Bank asked about managing the placebo effect in the upcoming emraclidine readout, given the potential for efficacy erosion seen in other schizophrenia trials.

    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.

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    James Shin's questions to Gilead Sciences Inc (GILD) leadership

    James Shin's questions to Gilead Sciences Inc (GILD) leadership • Q1 2025

    Question

    James Shin asked about the strong performance of Descovy in the quarter and whether this has positive read-throughs for the upcoming lenacapavir for PrEP launch.

    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.

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    James Shin's questions to Amgen Inc (AMGN) leadership

    James Shin's questions to Amgen Inc (AMGN) leadership • Q4 2024

    Question

    James Shin requested details on the indications for the MARITIME Phase III program, set to begin in the first half of 2025, and whether it would include head-to-head trials against competitors.

    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.

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