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    Ritu Baral • TD Cowen

    Ritu Baral's questions to Insmed Inc (INSM) leadership

    Ritu Baral's questions to Insmed Inc (INSM) leadership • Q2 2025

    Question

    Ritu Baral sought clarification on payer feedback for brensocatib, asking about the specific aspects of Insmed's approach that payers found positive, potential prior authorization requirements, and whether free drug would be provided at launch.

    Answer

    COO Roger Adsett explained that payers have shown strong alignment on the appropriate patient profile: a CT scan diagnosis and two or more exacerbations in the past year. He stated the goal is a 'frictionless launch' with a simple physician attestation for prior authorization. Adsett confirmed that Insmed does not plan to offer direct sampling or free product, but will provide patient support programs, including co-pay assistance for commercial patients.

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    Ritu Baral's questions to Insmed Inc (INSM) leadership • Q1 2025

    Question

    Ritu Baral asked if any FDA inspections for the Brensocatib review are still outstanding and questioned the clinical development path for TPIP if the PVR and 6-minute walk data were to diverge.

    Answer

    CEO William Lewis confirmed that while the FDA can inspect at any time, all scheduled inspections and the mid-cycle review have been completed without issue. Regarding TPIP, he stated that while data divergence is possible, it would be unexpected for a prostanoid, whose mechanism is well-established to benefit both measures.

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    Ritu Baral's questions to Insmed Inc (INSM) leadership • Q1 2025

    Question

    Ritu Baral asked if there are any outstanding inspections for the Brensocatib regulatory review and about the potential Phase III design for TPIP in the event of divergent PVR and 6-minute walk data.

    Answer

    CEO William Lewis responded that while the FDA can inspect up until approval, all inspections to date and the mid-cycle review have proceeded on schedule with no surprises. Regarding TPIP, he expressed low concern about divergent data, given the well-established benefits of the prostanoid class on both measures, but noted the company will analyze any aberrations closely if they occur.

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    Ritu Baral's questions to Insmed Inc (INSM) leadership • Q4 2024

    Question

    Ritu Baral questioned the impact of the IRA's manufacturer discount program on ARIKAYCE versus brensocatib, and asked if the upcoming TPIP data would include metrics on cough reduction.

    Answer

    CEO Will Lewis and CFO Sara Bonstein clarified that ARIKAYCE benefits from a phased-in discount as a 'specified small manufacturer,' while brensocatib will face the full 20% catastrophic coverage cost at launch. This is factored into gross-to-net guidance. Regarding TPIP, Lewis and CMO Martina Flammer explained its prodrug nature is designed to reduce cough, a hypothesis supported by low discontinuation rates in ongoing studies.

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    Ritu Baral's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    An analyst on for Ritu Baral asked about the expected labeling language for brensocatib, questioning if it would be broad or specific to exacerbation reduction, and whether adolescents would be included.

    Answer

    CMO Martina Flammer stated that Insmed expects a broad label for bronchiectasis and has requested the inclusion of adolescents, pending the FDA's final judgment. CEO Will Lewis added that while the FDA label may be broad, initial market access will likely focus on patients with two or more prior exacerbations, consistent with the trial population, which they hope to manage via physician attestation.

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    Ritu Baral's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    An analyst on behalf of Ritu Baral of TD Cowen inquired about the expected labeling language for brensocatib, specifically whether it would be broad or specify the reduction of exacerbations, and if adolescents would be included in the label.

    Answer

    CMO Martina Flammer stated that Insmed expects a broad label for non-CF bronchiectasis and will request the inclusion of adolescents, who were part of the clinical trial, pending FDA judgment. CEO Will Lewis added that while the FDA label may be broad, market access will likely initially focus on patients with two or more prior exacerbations, a requirement the company hopes to manage through physician attestation.

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    Ritu Baral's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership

    Ritu Baral's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q2 2025

    Question

    Ritu Baral asked for specifics on Daybue's new momentum, including the percentage of new patients from the community setting and the proportion of new HCP writers from that segment. She also had a follow-up on the ACP101 trial regarding dropout rates and the finalization of the statistical analysis plan (SAP) with the FDA.

    Answer

    Chief Commercial Officer Thomas Garner revealed that referrals from non-Center of Excellence (COE) accounts grew to about 75% of the total, up from two-thirds in the prior quarter, with the vast majority of new prescribers coming from outside COEs. EVP, Head of R&D, Elizabeth Thompson, commented on the ACP101 trial, stating that it is unfolding acceptably and that a statistical analysis plan is in place, though it can be modified before unblinding.

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    Ritu Baral's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q1 2025

    Question

    Ritu Baral of TD Cowen inquired about the criteria for positive data from the ACP-101 (carbetocin) trial and the strategy for modeling DAYBUE's European pricing, considering potential 'most favored nation' drug pricing policies.

    Answer

    An executive, likely Head of R&D Elizabeth Thompson, stated that a statistically significant result on hyperphagia would constitute a positive outcome for the ACP-101 trial. CEO Catherine Owen Adams addressed European pricing, expressing confidence in achieving a strong price for DAYBUE that reflects its value and noting that the company will assess any future pricing policies as they are implemented, given the lengthy reimbursement timelines in Europe.

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    Ritu Baral's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q3 2024

    Question

    An analyst on behalf of Ritu Baral of TD Cowen asked about forward adoption rates for Daybue in community practices versus academic centers. The question also covered how comfortable community physicians are with titrating the drug and what learnings are being applied from the early launch.

    Answer

    Executive Brendan Teehan explained that the further from a Center of Excellence, the more education is required on both Rett syndrome and Daybue's clinical profile. To address this, Acadia is using clinical champions from the early launch phase to lead peer-to-peer programs. These programs pair experienced clinicians with caregivers to share real-world performance insights and expectations, which has been a successful strategy for engaging community physicians.

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    Ritu Baral's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership

    Ritu Baral's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q2 2025

    Question

    Ritu Baral of TD Cowen asked about the strategy to maintain growth momentum with a potential Wegovy label expansion, inquiring about the next prescriber target after hitting 80% of the top tier and the plan for engaging endocrinologists.

    Answer

    CEO Bill Sibold responded that the focus is now shifting from prescriber breadth to depth, which is driven by positive real-world experience with ResDiffera. While hepatologists and gastroenterologists remain the primary focus, he confirmed they are expanding engagement with interested endocrinologists, who are particularly receptive to the drug's THR-beta mechanism of action.

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    Ritu Baral's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q1 2025

    Question

    Ritu Baral questioned the status of the European regulatory review, the reason for a clock stop extension, and how Europe's approach to non-invasive testing might impact Rezdiffra's label.

    Answer

    CEO William Sibold affirmed that the review is on track for a mid-year decision and the regulatory questions are expected for a first-in-class MASH therapy. He noted that Europe's physician community is well-prepared, with established EASL guidelines and a sufficient base of non-invasive testing (NIT) infrastructure to support a launch.

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    Ritu Baral's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q4 2024

    Question

    Ritu Baral from TD Cowen requested more detail on the data points that drive value in European health technology assessments (HTAs). She also asked for specifics on the safety profile in the F4 open-label cohort, particularly concerning events like hypoglycemia.

    Answer

    CEO William Sibold pointed to the formal value dossier process and the favorable U.S. ICER analysis as evidence of Rezdiffra's cost-effectiveness, which they will leverage in HTA discussions. Dr. Michael Charlton addressed safety, confirming that the adverse event profile in the F4c patients was comparable to that of non-cirrhotic patients in the study.

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    Ritu Baral's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q3 2024

    Question

    Ritu Baral questioned the utilization of the Medicare free drug program, citing physician feedback on logistical issues, and asked if the commercial co-pay program needs optimization due to its low utilization.

    Answer

    CEO William Sibold responded that free drug utilization has been very low, which he views as a positive indicator of strong insurance coverage. He stated he had not received the negative feedback but would monitor it. He expects co-pay assistance usage to increase over time as awareness grows. CFO Mardi Dier added that the time-to-fill for prescriptions has improved to 30 days, demonstrating system efficiency.

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    Ritu Baral's questions to Praxis Precision Medicines Inc (PRAX) leadership

    Ritu Baral's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q2 2025

    Question

    Ritu Baral from TD Cowen inquired about the biological mechanism for the deepening efficacy over time, whether exposure-response analysis supports the new 40mg dose, and for more specific timing on POWER-one data. She later asked for details on severe adverse events.

    Answer

    President & CEO Marcio Souza and CSO Steven Petrou explained the deepening effect is expected, with Petrou citing the reversal of the 'seizures beget seizures' process. Souza confirmed modeling supports the 40mg dose for potentially greater efficacy and clarified that severe AEs resolved quickly without discontinuing the drug.

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    Ritu Baral's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q3 2024

    Question

    Ritu Baral asked about the registrational sufficiency of the 80-patient expanded cohort for relutrigine, any changes to enrollment criteria, and the specifics of regulatory alignment for the EMERALD study in generalized epilepsies.

    Answer

    CEO Marcio Souza explained that the expanded relutrigine cohort is actively enrolling with a higher starting dose (1mg/kg/day) expected to yield a faster, deeper effect, but with no major changes to inclusion criteria. For the EMERALD study, he noted they are aligning with regulators on a traditional parallel group study design, with final details expected by year-end for a 2025 start.

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    Ritu Baral's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q2 2024

    Question

    Ritu Baral asked about FDA requirements for the Essential3 withdrawal study's responder rate, whether the PRAX-628 studies are placebo-controlled, the doses being used, the target for generalized epilepsy patients in RADIANT, and design differences between POWER1 and POWER2.

    Answer

    CEO Marcio Souza explained the withdrawal study uses a specific response criteria after 8 weeks to randomize patients, while non-responders move to a long-term extension. He confirmed RADIANT is open-label while POWER1 and 2 are placebo-controlled. Doses will be 30mg in RADIANT and a 20mg-to-30mg titration in POWER. He expects about 30% of RADIANT patients to have generalized epilepsy, reflecting clinical practice. POWER1 and 2 are similar but staggered to optimize enrollment.

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    Ritu Baral's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership

    Ritu Baral's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q2 2025

    Question

    Ritu Baral from TD Cowen asked about prescribing trends in the V122I variant population and sought clarification on payer terminology like 'step-through' versus 'prior authorizations'.

    Answer

    CCO Tolga Tanguler clarified that payer policies generally do not restrict access based on hereditary status like V122I. CMO Pushkal Garg added that HELIOS-B data showed Amvuttra works equally well in both wild-type and V122I patients, supporting its use as a first-line agent across the board.

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    Ritu Baral's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q1 2025

    Question

    Ritu Baral asked for the profile of patients receiving AMVUTTRA as a first-line therapy and sought clarification on whether health system formulary inclusion also establishes prior authorization requirements.

    Answer

    Chief Commercial Officer Tolga Tanguler clarified that health system formulary inclusion is about the institution's ability to purchase and administer the drug, separate from payer-level prior authorizations. Regarding first-line use, he explained that physicians who understand AMVUTTRA's differentiated profile are using it broadly for both newly diagnosed patients and those progressing on stabilizers, rather than for a specific patient subtype.

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    Ritu Baral's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q4 2024

    Question

    Ritu Baral followed up on the label topic, asking about the potential commercial advantage of having mortality data included in the clinical data section of the label for detailing and payer discussions.

    Answer

    Chief Commercial Officer Tolga Tanguler expressed confidence in their ability to communicate the product's benefits, given significant results on all prespecified endpoints. Chief Medical Officer Pushkal Garg added that they expect the label to reflect the clinical trial results, enabling the commercial and medical teams to educate providers on all attributes of the HELIOS-B study.

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    Ritu Baral's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q3 2024

    Question

    Ritu Baral inquired about Alnylam's current payer discussions for AMVUTTRA ahead of a potential label expansion, focusing on negotiation levers and the possibility of volume-based discounts.

    Answer

    Chief Commercial Officer Tolga Tanguler stated that payer discussions are centered on the strong value proposition and compelling clinical outcomes from the HELIOS-B study. He mentioned that their patient access strategy includes value-based agreements and rebates, with more specific details to be shared closer to the PDUFA date.

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    Ritu Baral's questions to Sarepta Therapeutics Inc (SRPT) leadership

    Ritu Baral's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q1 2025

    Question

    Ritu Baral inquired about the strategy to direct patients to sites with more capacity, asking if these are community sites and why they are not already at capacity, and if the company plans to open more sites.

    Answer

    President and CEO Douglas Ingram explained that it's a focus issue, not a site number issue. The company initially prioritized large, high-experience sites which are now fully booked. The strategy is now to increase educational outreach and engagement with secondary sites that have available capacity to make them more productive. He clarified they cannot redirect start forms but can drive awareness to balance the network.

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    Ritu Baral's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q4 2024

    Question

    Ritu Baral of TD Cowen asked about the potential for a splicing biomarker-based accelerated approval for the FSHD and DM1 programs and requested a description of the planned manufacturing bridging study.

    Answer

    CEO Douglas Ingram described the bridging study as a relatively small, fast-moving trial empirically comparing expression and safety between the suspension and adherent manufacturing processes. Regarding accelerated approval, Dr. Louise Rodino-Klapac noted that for FSHD, the ability to quantify DUX4 knockdown provides a unique biomarker opportunity. She stated that while splicing is one of many biomarkers being evaluated for DM1, it's too early to say if it could be a sole basis for approval.

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    Ritu Baral's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q3 2024

    Question

    Ritu Baral from TD Cowen inquired about Sarepta's approach to forward guidance, asking if the company would continue to provide granular forecasts given its 3-to-5-month visibility into the patient pipeline, and what swing factors to consider.

    Answer

    President and CEO Doug Ingram affirmed that the company's goal is to provide reasonable and accurate guidance that it is comfortable with, even if it appears conservative. He acknowledged that deep insight into the patient pipeline provides significant confidence but stated they would not update guidance at this time and would likely discuss 2025 at the January JPMorgan conference.

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    Ritu Baral's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q2 2024

    Question

    Ritu Baral asked if the previously guided ~$4 billion peak sales figure for ELEVIDYS still holds and what factors explain the tight range of the 2025 revenue guidance.

    Answer

    CEO Douglas Ingram confirmed that the company has no basis to amend its prior long-term peak sales guidance for ELEVIDYS. He explained that the confidence in the 2025 guidance comes from extensive experience, algorithmic modeling of launch curves, and granular data on start forms, which indicate the current launch is exceeding their optimistic expectations.

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    Ritu Baral's questions to Krystal Biotech Inc (KRYS) leadership

    Ritu Baral's questions to Krystal Biotech Inc (KRYS) leadership • Q1 2025

    Question

    Ritu Baral questioned the specifics of the sales force expansion, including headcount and roles, and asked if the initiative was driven by the rising proportion of DDEB patients or potential competition.

    Answer

    Jennifer McDonough, SVP of Patient Access, confirmed the field force was enhanced in Q1 to support deeper community outreach. Krish Krishnan, Chairman and CEO, clarified the expansion is not related to competition but is a response to the longer education cycle required for physicians and patients in the community, particularly as the mix of DDEB patients increases. He stressed it's about shortening the time to get a patient start form.

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    Ritu Baral's questions to Krystal Biotech Inc (KRYS) leadership • Q4 2024

    Question

    Ritu Baral asked for details on the upcoming European launch, including the breakdown of the 1,000 identified patients in Germany and France, the role of centers of excellence, expected pricing frameworks, and the potential for home dosing.

    Answer

    Chairman and CEO Krish Krishnan detailed that the patient split is approximately 600 in Germany and 400 in France, with France being more concentrated in centers of excellence. He outlined that Germany allows launching at the U.S. price for six months before a negotiated price is set, while France's access program requires accruing for rebates from day one. He also confirmed that home dosing is expected in Europe.

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    Ritu Baral's questions to Krystal Biotech Inc (KRYS) leadership • Q3 2024

    Question

    Ritu Baral focused on the European launch, asking about the status of the EMA's 180-day questions, expectations for the label's breadth (from birth, dominant vs. recessive), and how investors should model European pricing relative to the U.S.

    Answer

    An executive, likely President of R&D Suma Krishnan, confirmed that responses to the 180-day questions were submitted and no oral arguments are currently expected. The anticipated label includes patients from birth with both dominant and recessive DEB, with home dosing also on track. Chairman and CEO Krish Krishnan stated that while they will aim for the highest price, a conservative blended European price would be around 50% of the U.S. price, with a goal to land between 50% and the full U.S. price.

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    Ritu Baral's questions to Amicus Therapeutics Inc (FOLD) leadership

    Ritu Baral's questions to Amicus Therapeutics Inc (FOLD) leadership • Q1 2025

    Question

    Ritu Baral of TD Cowen asked about the DMX-200 trial, specifically what eGFR benefit the FDA requires, the timeline for the next interim analysis, and what evidence supports the expected acceleration of U.S. switches to Pombiliti/Opfolda.

    Answer

    Chief Development Officer Dr. Jeff Castelli clarified the FDA agreed to proteinuria for full approval, requiring only supportive, not statistically significant, eGFR data. He estimated the next interim analysis could be in roughly 9 months. President and CEO Bradley Campbell addressed the Pombiliti/Opfolda question, citing a significant acceleration in U.S. switches already seen in April, driven by more Nexviazyme patients reaching the two-year switch window and growing real-world evidence.

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    Ritu Baral's questions to Amicus Therapeutics Inc (FOLD) leadership • Q3 2024

    Question

    Ritu Baral inquired about the specifics of Pombiliti's prescribing trends, including the drivers for physicians and patients to switch therapies in the U.S., and requested a quantification of the Pompe market opportunity in Japan.

    Answer

    President and CEO Bradley Campbell and Chief Development Officer Dr. Jeff Castelli explained that prescribing trends show growth in both new prescribers (breadth) and repeat prescriptions (depth). They noted physicians typically monitor patients for 12-24 months on a new therapy before considering a switch, often prompted by signs of clinical decline. Chief Business Officer Sebastien Martel added that the Japanese Pompe market is relatively small, with approximately 100 patients currently on treatment.

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    Ritu Baral's questions to Amicus Therapeutics Inc (FOLD) leadership • Q2 2024

    Question

    Ritu Baral asked about Amicus's counter-messaging to competitive claims from Genzyme and also questioned the reimbursement process, citing anecdotes of coverage issues for the Opfolda component.

    Answer

    President and CEO Bradley Campbell and Chief Development Officer Dr. Jeff Castelli addressed the competitive dynamic by highlighting Pombiliti and Opfolda's unique Phase 3 data showing improvement versus an active comparator, allowing them to message that 'improvement is possible.' Regarding reimbursement, Campbell stated they have not seen denials for either component and that the time from prescription to infusion is shortening as expected, now down to ~65 days.

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    Ritu Baral's questions to Compass Pathways PLC (CMPS) leadership

    Ritu Baral's questions to Compass Pathways PLC (CMPS) leadership • Q4 2024

    Question

    Ritu Baral asked if the top-line data release would include secondary analyses like remission or response rates, inquired about patient disposition and background SSRI use, and questioned if the study's statistical powering would be disclosed.

    Answer

    CEO Kabir Nath stated clearly that the 6-week data will not include secondary analyses, remission, or response rates, focusing only on the MADRS effect size difference. He mentioned that patient characteristics appear similar to Phase IIb but could not provide precise statistics mid-trial. He confirmed the company would be willing to share the study's powering details with the data release.

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