Umer Raffat • Evercore ISI

Answer

Chairman and CEO Daniel O’day acknowledged ongoing discussions with the administration, emphasizing Gilead's strong position with new launches and limited patent exposure. Chief Commercial Officer Johanna Mercier added that Medicaid represents the mid-to-lower 20% range of the HIV business and patient out-of-pocket costs are already minimal. She noted that any legislative impact would likely not be immediate, and stressed that HIV treatment has robust safety nets like ADAP and patient assistance programs to ensure continuous access.

Ask Fintool Equity Research AI

Answer

CEO Daniel O’day noted that Gilead is engaged in policy discussions and emphasized the company's strong position with limited patent exposure until 2033. Chief Commercial Officer Johanna Mercier added that the HIV Medicaid business is in the mid-to-lower 20% range and that patient out-of-pocket costs are already minimal. She highlighted the robust safety net of state programs, ADAP, and foundations that ensure patient access.

Ask Fintool Equity Research AI

Answer

Cindy Perettie, EVP of Kite, responded that she could not provide the specific level of detail for each case on the call. However, she confirmed that they did not observe cases of tremors among those patients and offered to follow up with additional information.

Ask Fintool Equity Research AI

Answer

An executive, likely EVP of Kite Cindy Perettie, stated the company believes the favorable safety profile is due to anito-cel's construct, particularly its compact DD domain. With data from over 140 patients across Phase I and II studies showing no cases of delayed neurotoxicity, the company has increasing confidence that it has a best-in-class construct and looks forward to presenting a larger dataset at the upcoming ASH conference.

Ask Fintool Equity Research AI

Answer

CEO Scott Smith explained that while the situation is being monitored, it's currently unclear if tariffs will be applied to pharmaceuticals. He noted that about half of U.S. revenue is sourced domestically and that India represents about 10% of revenue. Smith emphasized that Viatris has mitigation plans in place and does not anticipate a material financial impact in 2025 from any potential tariffs.

Ask Fintool Equity Research AI

Answer

CEO Scott Smith reiterated that over 50% of U.S. revenue is sourced from its 8 U.S. facilities, with the rest from Ireland, the U.K., and India. On meloxicam, Chief R&D Officer Philippe Martin stated that clinical trials showed no increased bleeding risk despite a higher Cmax. Chief Commercial Officer Corinne Le Goff added that the drug is positioned for both hospital and outpatient use in various acute pain settings.

Ask Fintool Equity Research AI

Answer

CEO Scott Smith defended the communication, citing the situation was highly dynamic and the final impact, particularly on lenalidomide, was not clear until just days before the call. Regarding Idorsia, Chief R&D Officer Philippe Martin and CEO Scott Smith pointed to positive feedback from KOLs and safety committees, the growing importance of the assets, and the strategic benefit of taking more control to ensure data integrity and secure better long-term economics.

Ask Fintool Equity Research AI

Answer

Dr. Daniel Skovronsky, Chief Scientific Officer, responded that the overall profile landed where a GLP-1 monotherapy would be expected. He cautioned against making difficult cross-trial comparisons, stating that he does not see the numerical debate as an issue for real-world adoption by patients and physicians.

Ask Fintool Equity Research AI

Answer

Dr. Dan Skovronsky, Chief Scientific Officer, stated that the overall liver safety profile, including mean changes and excursions, showed nothing of concern and looked similar to placebo. Regarding diarrhea, he acknowledged the rates were higher but noted the placebo rate was also higher, suggesting variability by trial region. He emphasized that the most telling indicator of tolerability is the low rate of discontinuations due to adverse events.

Ask Fintool Equity Research AI

Answer

Executive Daniel Skovronsky responded that the current focus is on broad primary care applications where an oral drug has advantages. He acknowledged an outcomes trial is an interesting idea being explored globally but highlighted the increasing difficulty of running placebo-controlled studies.

Ask Fintool Equity Research AI

Answer

Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA, noted the LillyDirect self-pay option had a limited, low single-digit impact on Q3 prescriptions. An executive then gave a direct "no" to both questions, confirming there were no changes to distributor terms and no perceived impact on retail stocking from the LillyDirect launch.

Ask Fintool Equity Research AI

Answer

CFO Terrance Coyne advised that for now, investors should assume the 4% royalty rate Vertex is currently paying, while reiterating the company's belief it is owed 8%. Head of Research & Investments Marshall Urist explained the RevMed deal structure was a collaborative effort to meet the partner's capital needs and later confirmed that the next-generation SPINRAZA is included in their royalty agreement.

Ask Fintool Equity Research AI

Answer

James Bradner, EVP of R&D, provided a direct answer, stating that the study's readout is "purely based on accumulated events or event rate."

Ask Fintool Equity Research AI

Answer

James Bradner, EVP of R&D, highlighted UPLIZNA's strong, durable efficacy, steroid-sparing potential, and convenient 6-month dosing. Murdo Gordon, EVP of Global Commercial Operations, added that while payer policies follow the label, real-world evidence could eventually demonstrate a cost advantage for UPLIZNA. Management did not provide a specific market share target.

Ask Fintool Equity Research AI

Answer

EVP of R&D James Bradner clarified that the Phase I study did not include dose titration, limiting its predictive value on that front. He stated that the company is focused on the upcoming Phase II data. Regarding the weight loss plateau, he noted it will be an interesting observation to learn from the full 52-week data.

Ask Fintool Equity Research AI

Answer

CEO Albert Bourla noted less sensitivity from Congress on in-licensing technology from China for U.S. development and manufacturing, as seen with the 3S Bio deal. Chief Scientific Officer Chris Boshoff clarified that the study size for the SV trial was recalculated based on emerging data from other ongoing trials, not from an unblinding of the Phase 3 study.

Ask Fintool Equity Research AI

Answer

Chairman & CEO Albert Bourla clarified that government sensitivity is higher for technology transferred to China, not for licensing science from China for U.S. development, citing the 3S Bio deal. Chief Scientific Officer Chris Boshoff confirmed the Phase 3 SV trial was not unblinded and that sample size recalculations are based on emerging data from other ongoing studies.

Ask Fintool Equity Research AI

Answer

CFO Dave Denton confirmed that productivity improvements are designed to bolster operating margins through the LOE period and that the dividend commitment is 'steadfast.' CEO Albert Bourla highlighted the $7.7 billion cost savings target by 2027 and asserted that his discussions with the government indicate a clear focus on national security concerns related to non-friendly countries.

Ask Fintool Equity Research AI

Answer

Chief Scientific Officer Mikael Dolsten did not disclose specific Phase I weight loss data but highlighted the GIP antagonist's potential to enhance efficacy when combined with a GLP-1. Regarding the vaccine, he declined to detail the carrier protein strategy but emphasized that the platform includes significant technical improvements, such as enhanced immunogenicity for serotype 3 in the 25-valent version.

Ask Fintool Equity Research AI

Answer

Kevin Ali, CEO & Board Member of Organon, responded that the company has just recently initiated its full investment push with DTC and telehealth campaigns and an expanded sales force. He emphasized that significant progress in improving market access and lowering the gross-to-net ratio is a key precursor to volume growth, expressing confidence in the second-half performance based on a strong exit from Q2.

Ask Fintool Equity Research AI

Answer

CEO Kevin Ali attributed the change to the volatile macroeconomic environment and clear investor feedback prioritizing lower leverage. He stated the decision was made from a position of strength to accelerate deleveraging, which will ultimately enable more growth-focused business development. He clarified the primary focus is deleveraging, as 2025 tariff exposure is manageable.

Ask Fintool Equity Research AI

Answer

CEO Kevin Ali explained that Organon did not follow Dermavant's previous practice of pulling sales forward into the end of a quarter, opting for a clean start in 2025. He confirmed the back-half weighting of VTAMA's sales is accurate, with growth expected to accelerate throughout the year driven by improved managed care access and strong prescription trends.

Ask Fintool Equity Research AI

Answer

Chief Financial Officer Matthew Walsh confirmed the $180 million OpEx figure is U.S.-focused with no significant international spend included. He stated that while promotional spending is flexible, the company's full energy in 2025 will be dedicated to a successful launch, and any potential budget retrenchment would only be considered beyond 2025.

Ask Fintool Equity Research AI

Answer

CEO Christopher Viehbacher affirmed Biogen's deep commitment to Alzheimer's and described the relationship with Eisai as "better than it has ever been." He acknowledged a specific disagreement over the European launch is being handled via the contractual arbitration process but stressed it has not impacted the strong overall working relationship across all functions.

Ask Fintool Equity Research AI

Answer

CEO Christopher Viehbacher affirmed Biogen's deep commitment to Alzheimer's and described the relationship with Eisai as "better than it has ever been." He acknowledged the arbitration regarding the European launch but characterized it as a normal part of the contractual process that has not negatively impacted the strong overall working relationship between the two companies.

Ask Fintool Equity Research AI

Answer

Dr. Priya Singhal, Head of Development, expressed confidence in the AHEAD 345 trial design and its 2028 readout, while noting they always evaluate options for earlier data cuts. President and CEO Christopher Viehbacher stated that increased confidence in the internal pipeline lessens the pressure for large M&A, and defended the Reata acquisition as a long-term value driver.

Ask Fintool Equity Research AI

Answer

Dr. Priya Singhal, Head of Development, argued that while innovative, CAR-T data is from small populations and may not be broadly applicable to the heterogeneous SLE patient base. CEO Christopher Viehbacher added that logistical hurdles with CAR-T and the high failure rate in lupus drug development suggest a need for multiple treatment approaches, positioning Biogen's assets favorably.

Ask Fintool Equity Research AI

Answer

CEO Thomas Appio highlighted the significant market opportunity for the Rifaximin SSD formulation, targeting a 1.9 million patient population in the U.S. He stated that a XIFAXAN OTC switch has not been considered at this time and that the team would follow up with specific details regarding lactulose use in the trial design.

Ask Fintool Equity Research AI

Answer

CEO Thomas Appio argued the RED-C program's new formulation (rifaximin SSD) and global scope would differentiate it from generics. Interim CFO John Barresi clarified that cash flow guidance is post-interest, underscoring the need for debt reduction, and pointed to growth in non-XIFAXAN businesses like Solta and the pipeline as key to the long-term strategy.

Ask Fintool Equity Research AI

Answer

President and CEO Richard Francis stated Teva would not comment on ongoing IRA negotiations. Regarding tariffs, both Francis and EVP & CFO Eli Kalif explained that mitigation plans are in place, Teva has limited exposure to China, and any confirmed tariffs have already been absorbed into the 2025 guidance without a currently foreseen meaningful impact.

Ask Fintool Equity Research AI

Answer

Dr. Dean Li, President of Merck Research Labs, confirmed that the program is proceeding exactly as planned. He noted Merck's long-standing interest in this dual signaling space, dating back to 2018.

Ask Fintool Equity Research AI

Answer

Dr. Dean Li, President of Merck Research Laboratories, confirmed that Merck has been interested in this dual-signaling space since 2018. He stated that the program with Kelun-Biotech is proceeding exactly as planned according to the original partnership agreement.

Ask Fintool Equity Research AI

Answer

CEO Robert Davis declined to answer the question, stating that the company has not disclosed the location of the IP for subcutaneous KEYTRUDA and preferred not to discuss it for proprietary reasons.

Ask Fintool Equity Research AI

Answer

CEO Robert Davis affirmed the company's confidence in WINREVAIR's growth potential, stating that its importance to the company remains unchanged. He noted that January's performance was returning to expected levels and that the company foresees WINREVAIR as a strong growth contributor in 2025, supported by strong underlying fundamentals.

Ask Fintool Equity Research AI

Answer

CEO Robert Davis stated that while inventory at their partner Zhifei remains high, overall channel inventory in China has decreased. He clarified that Merck is intentionally shipping below end-market demand to facilitate this inventory reduction. The $2-$3 billion forecast for the coming years incorporates these inventory dynamics as well as the potential for local competition.

Ask Fintool Equity Research AI

Answer

Richard Pops, Chairman & CEO, deferred on dose-response linearity until the World Sleep meeting. Marcus Yountz, VP of Clinical Development, confirmed the pre-specified use of the negative binomial analysis was appropriate and discussed with the FDA. Pops added that other data perspectives will clearly show the drug's effect on cataplexy and that this represents a methodological learning for Phase 3.

Ask Fintool Equity Research AI

Answer

Dr. Craig Hopkinson, CMO, explained that efficacy is viewed both by comparing to currently approved therapies and by the potential to normalize wakefulness patterns. CEO Richard Pops clarified that prior visual events (blurred vision, light sensitivity) were not interpreted as REM sleep intrusions or a failure of efficacy, and that more data is needed to draw conclusions.

Ask Fintool Equity Research AI

Answer

CEO Richard Pops described the orexin study enrollment as a "horse race," with more clarity on timing expected in a few months. CCO C. Nichols explained the LYBALVI guidance, noting strong underlying HCP breadth growth, the impact of the sales force expansion, and a planned widening of gross-to-net to the mid-30s range driven by improved market access.

Ask Fintool Equity Research AI

Answer

CEO Richard Pops clarified that lowering Cmax is not an explicit design objective for next-gen orexins, as the PK profile for ALKS 2680 is considered quite good. COO Blair Jackson explained the 2025 EBITDA forecast is primarily due to a ~$200 million revenue impact from the conclusion of INVEGA SUSTENNA royalties and the transition of VUMERITY manufacturing, plus increased investment in the ALKS 2680 program and the psychiatry sales force.

Ask Fintool Equity Research AI

Answer

CEO Terry Rosen explained the 100mg dose was chosen after FDA discussions, as it appears to be on the asymptote for efficacy with a very safe profile. President Juan Jaen clarified the post-IO cohort is a mix of patient types and that the goal is to demonstrate an improvement in both safety and efficacy, as the two are linked to keeping patients on therapy.

Ask Fintool Equity Research AI

Answer

CEO Grant Pickering confirmed they will use the 15-point delta for the Phase II analysis, consistent with precedent, to predict success against the 10-point registration hurdle in Phase III. EVP & COO Jim Wassil expressed confidence in serotypes 3 and 12F based on strong adult data, but noted that even a few misses would still result in a strong product profile. Pickering firmly stated that no post-dose 4 data would be unblinded early to maintain data integrity, with the full dataset expected later in the year.

Ask Fintool Equity Research AI

Answer

President and CEO Gene G. Kinney stated that since the PRONTO and VITAL trials are no longer ongoing, there is no long-term mortality follow-up data available. He did reiterate the hazard ratio of 0.413 in VITAL's Mayo Stage IV cohort. Chief Development Officer Chad Swanson clarified that since the endpoint was all-cause mortality, all deaths were counted in the analysis.

Ask Fintool Equity Research AI

Answer

CMO Mythili Koneru highlighted a significant decrease in delayed neurotoxicity in the CARTITUDE-4 trial due to better patient management, noting that monitoring ALC and using steroids can further mitigate risk. CEO Ying Huang confirmed the autoimmune program has begun enrollment, with initial data expected in 2025.

Ask Fintool Equity Research AI