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President and CEO Ian Mortimer stated that the liver toxicity of a prior drug (flupertine) was likely not on-target and that Xenon has no current concerns with its candidate, XEN1101. He also confirmed the top-line release will be detailed, consistent with past disclosures. Chief Medical Officer Christopher Kenney noted that while they have strong QoL data, specific pain data is limited to migraine headache capture in the epilepsy trials, which did not enrich for that comorbidity.

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Chief Medical Officer Dr. Chris Kenney clarified that Xenon is studying the depressive phase of the illness, where the underlying pathophysiology is considered similar between types. He noted the negative mania data is somewhat reassuring as it suggests the mechanism doesn't worsen mania. Both he and CEO Ian Mortimer confirmed the IST dosing was once-daily and the use of two pills versus one was due to supply and would not be expected to alter clinical outcomes.

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CMO Dr. Chris Kenney explained that with two positive MDD studies potentially completed by the time the bipolar data is available, the regulatory bar for a bipolar indication could be lower, possibly requiring fewer studies. CEO Ian Mortimer addressed the PGTCS study, acknowledging that enrollment is challenging due to the lower prevalence of the condition and the tendency for immediate physician intervention, which often makes patients ineligible for clinical trials.

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CEO Ian Mortimer confirmed that the new candidates are novel chemical structures with new, distinct IP. He clarified that the goal is not to fix a specific deficiency in azetukalner's already compelling profile, but rather to build a franchise with chemical diversity. Learnings from azetukalner on required plasma exposure levels for efficacy will be leveraged to guide the development of these new molecules.

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CEO Dr. Matthew Klein stated that the company is focused on success and is ready to launch vutiquinone immediately upon approval, leveraging its existing infrastructure. The initial target would be patients under 16, who currently have no approved therapies, a population served by pediatric ataxia centers PTC has long-standing relationships with. He affirmed PTC's commitment to patients and its belief in the drug's supportive data, implying they would continue to support the program.

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Interim Chief Medical Scientist Bruce Given expressed confidence in trial adherence based on past experience and robust trial execution. Regarding the data release, he noted the results would be available close together, while CEO Christopher Anzalone added that his initial thought is to release them all at once, though a final decision has not been made.

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Chief Medical Officer Dr. Camille Bedrosian explained that patients receive extensive dietary training and are asked to maintain their run-in period diet, which is reinforced at every visit. For the PSP program, she stated the decision will be based on the totality of data, including the PSPRS clinical endpoint, biomarkers, and imaging, with a high bar set for advancing.

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Co-CEO Marella Thorell explained that the primary goal for any deal is to secure capital to advance SER-155, with various structures like partnerships or mergers being considered. Co-CEO Thomas DesRosier added that merger discussions are active with companies that could benefit from Seres' regulatory expertise. Regarding the trial, Thorell confirmed the Phase II study will be global, and SVP of Clinical Development Dennis Walling noted strong enthusiasm from European KOLs.

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President and CEO Eric Shaff stated that despite general concerns about the FDA, Seres' own interactions have been 'highly constructive and regular,' possibly aided by SER-155's Breakthrough Therapy Designation. On partnerships, he confirmed progress and urgency but declined to give a specific timeline, noting potential partners are being briefed on the study design. Regarding the interim analysis, Eric Shaff and Dr. Dennis Walling confirmed it provides optionality but clarified the current expectation is that the Phase 2 study will inform a separate pivotal Phase 3 study, pending FDA discussions.

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Eric Shaff, President and CEO, explained that while the company is preparing for either a standalone Phase II or a seamless Phase II/III, the immediate next step is submitting the clinical protocol to the FDA. He noted that a partner's input would be valuable in this decision. Lisa von Moltke, CMO, added that they believe they have the correct, broad patient population for the next study. Chris McChalicher, Head of Manufacturing and Quality, confirmed that recent FDA feedback was confirmatory, allowing them to proceed with the current manufacturing campaign for the upcoming trial.

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President and CEO Eric Shaff and Chief Medical Officer Dr. Lisa von Moltke explained that they would seek synergies in trial design, possibly through a basket study or adaptive arms, and would not need a new Phase I study due to established safety. Regarding the drug compositions, Chief Scientific Officer Matthew Henn clarified that while SER-155 and SER-147 are different consortia of bacteria, the specific strains are not disclosed. He noted SER-147 is optimized for the distinct pathogens and unique GI environment found in chronic liver disease patients.

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CEO Mike Raab and CFO Justin Renz characterized the debt draw as a prudent move to strengthen the balance sheet at a favorable interest rate, providing flexibility. Regarding the sales force, both executives expressed confidence in the current team sizes for Ibsrela and Xphozah, noting they continuously assess optimization.

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CFO Justin Renz projected that SG&A would rise from Q1's $83.2 million to about $90 million by year-end, with modest growth in R&D from its $14.9 million base. CCO Eric Foster noted that the non-Medicare business (commercial and Medicaid) gained momentum throughout Q1 as the impact of one-time Medicare transitional fills from early in the quarter subsided, reinforcing their strategy.

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CCO Eric Foster stated that while physicians are aware of the changes, the operational impact is primarily on dialysis organizations, allowing Ardelyx to maintain a simple 'prescribe as needed' message. President and CEO Michael Raab noted the BD strategy is focused on assets within their current therapeutic areas that fit the company's skill set.

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President and CEO, Mike Raab, stated he doesn't anticipate stocking issues due to a continuity of care program. He noted it's premature to discuss next steps on a potential injunction. He also explained that the required infrastructure changes are debilitating for dialysis providers, which is a key reason many support the Kidney Patient Act to avert what he called a 'catastrophe.'

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Chief Executive Officer Dr. Herriot Tabuteau described the trial as a standard parallel group design using a pediatric scale. He said confidence is based on the fact that other ADHD drugs work in both populations and the diagnosis requires childhood onset. He acknowledged the complexity of pediatric trials requires 'perfect alignment' with the FDA.

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Chief Executive Officer Dr. Herriot Tabuteau explained that the primary goal is for the trial to be positive by meeting its primary endpoint, without targeting a specific magnitude of difference. He noted that comparisons to competitors like Qelbree would have to wait until the data is unblinded, which is expected very soon.

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CEO Herriot Tabuteau explained that solriamfetol offers a novel mechanism for MDD and is being studied in patients with and without excessive daytime sleepiness. For AXS-05, he noted patients are sourced from specialized clinical trial centers, and the program's focus on community-dwelling patients is a key differentiator.

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Dr. Leigh Peterson, Vice President of Product Development, explained that to minimize FVC variability, the company employed central readers for all results and implemented extensive, standardized training at clinical sites for pulmonary function testing procedures, aiming for more consistent and true results.

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Dr. Leigh Peterson, EVP of Product Development and Xenotransplantation, confirmed the UTHYMOKIDNEY study will target a nearly identical patient population. She explained that the recent explant was due to an unrelated infection requiring a reduction in immunosuppression, which led to rejection. Key learnings involve better management of immunosuppression during such events, and the experience is viewed as a positive step forward.

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Dr. Leigh Peterson, EVP of Product Development and Xenotransplantation, clarified that due to patient privacy in a formal clinical study, individual progress will not be publicized. She detailed the two eligible patient populations: those medically ineligible for the transplant list and those on the list but not expected to receive a transplant for at least five years.

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Michael Benkowitz, an executive, responded that de-escalation from Remodulin to Orenitram is not yet a widespread trend. He confirmed that the expedite protocol is expected to result in higher average doses for Orenitram, as patients can reach a therapeutic dose much faster (within 1-2 months versus up to 6 months), which should cause the average dose to increase over time.

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CEO Matt Kapusta stated their patient-safety-first approach and center-of-excellence launch strategy remain unchanged, highlighting AMT-130's favorable local administration profile. CMO Walid Abi-Saab explained the new cohort aims to gather safety data in patients with lower striatal volumes, but it is too early to speculate on the final label.

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CMO Dr. Walid Abi-Saab clarified the FDA's most recent data view was from a June 2024 cut and they have not seen any data since, including from Cohort 3. He also confirmed the proposed 2-week steroid regimen is new, as prior cohorts did not receive systematic perioperative immunosuppression, and it was chosen for its well-understood, low-risk safety profile.

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Marcus Yountz, VP of Clinical Development, explained that while similarities are expected, the follow-on molecules have different structures and pharmacokinetic profiles that could lead to different outcomes. Richard Pops, Chairman & CEO, added that Alkermes hypothesizes a tolerability shift between NT1 and NT2 patients, which is being explored in the clinical program.

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Dr. Craig Hopkinson, Chief Medical Officer, explained that ESS was elevated to a dual primary endpoint to align with the competitive landscape and global regulatory expectations. He clarified that while doses are fixed during the double-blind phase, the open-label extension allows patients to titrate their dose, which will provide valuable data for planning the Phase III program.

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Chief Commercial Officer Todd Nichols stated that Alkermes is monitoring GLP-1s but does not currently see an impact on VIVITROL, which saw strong demand driven by the alcohol dependence indication. CEO Richard Pops confirmed that abuse potential studies for the orexin program are anticipated as a matter of course for CNS-active compounds.

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Rob Iannone, Head of R&D, clarified that the enrollment pause was limited to the U.S. to prevent data confounding post-approval and that the trial is enrolling well. He affirmed that the FDA review is proceeding as expected, with no indication of a delay to the August 18 PDUFA date, and noted they may adjust the trial's analysis plan to ensure it is well-powered.

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EVP, Global Head of R&D Robert Iannone explained the trial has 'two shots on goal.' For approval, either the doublet (zani + chemo) or triplet (zani + chemo + PD-1) arm must show benefit over the control arm. He noted the triplet arm would need to demonstrate an incremental benefit over the doublet. He expressed confidence in the doublet arm's potential for success.

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EVP, Global Head of R&D, Rob Iannone, clarified that the trial has 'two shots on goal.' Approval could be based on either the zanidatamab-plus-chemo arm or the zanidatamab-plus-chemo-plus-PD-1 arm demonstrating superiority over the control. He noted the triplet arm would need to show an incremental benefit over the doublet. Management is confident in the doublet arm's potential for success regardless of PD-L1 status.

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CMO David Lebwohl differentiated Intellia's gene editing from AAV gene therapy, emphasizing its straightforward outpatient administration. He stated that the drug's ability to provide a 'functional cure'—freedom from attacks and ongoing therapy—is what patients desire and will drive uptake. He also noted that payer engagement is already underway.

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CEO John Leonard clarified that the PN and CM programs are independent for efficacy, though safety data will be shared between them. He confirmed the study will remain blinded, so no premature TTR data will be released. CMO David Lebwohl added they are confident in TTR reduction based on prior experience.

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