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    Tara Bancroft's questions to Urogen Pharma Ltd (URGN) leadership

    Tara Bancroft's questions to Urogen Pharma Ltd (URGN) leadership • Q2 2025

    Question

    Tara Bancroft of TD Cowen inquired about early launch metrics for Zestory in July, asking for details on script rates, active accounts, or qualitative feedback on pent-up patient demand.

    Answer

    President & CEO Liz Barrett and CCO David Lin explained that while specific metrics would not be shared this early, they are encouraged by the positive receptivity from healthcare providers. Barrett noted that patient enrollment forms are coming in and site-of-care setups are on track. She emphasized that reimbursement is the primary hurdle, with many physicians waiting for the permanent J-code in 2026, but confirmed the company is aligned with consensus estimates for the year.

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    Tara Bancroft's questions to Urogen Pharma Ltd (URGN) leadership • Q1 2025

    Question

    Tara Bancroft inquired about the anticipated Medicare and Medicaid exposure for UGN-102 and the current mix for JELMYTO, as well as the potential pricing dynamics.

    Answer

    CEO Liz Barrett clarified that as a U.S.-only company, UroGen has no international pricing risks. Chief Commercial Officer David Lin added that they anticipate the Medicare population will constitute approximately 70% of the business for UGN-102, which is consistent with the patient demographic for low-grade intermediate risk NMIBC.

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    Tara Bancroft's questions to Urogen Pharma Ltd (URGN) leadership • Q3 2024

    Question

    Tara Bancroft inquired about the FDA's rationale for granting a standard review instead of a priority review for UGN-102, seeking details from the 72-day letter or other communications.

    Answer

    President and CEO Liz Barrett explained that the FDA's letter did not comment on the review type but focused on standard review questions regarding the ENVISION and ATLAS trial data. She speculated that the standard timeline better accommodates the expected ODAC meeting and gives the agency more time, as they had not yet reviewed the clinical data when the application was accepted.

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    Tara Bancroft's questions to Day One Biopharmaceuticals Inc (DAWN) leadership

    Tara Bancroft's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q2 2025

    Question

    Tara Bancroft from TD Cowen asked for the proportion of new versus continuing scripts in Q2 and questioned the extent to which recent ASCO data on rash management and growth velocity contributed to new patient starts.

    Answer

    CEO Jeremy Bender confirmed the positive impact of the two-year data. CCO Lauren Merendino added that the data was well-received by physicians, as it confirmed Ogenda's efficacy and provided reassuring evidence of catch-up growth post-treatment, which directly contributed to an uptick in new patient starts in the latter half of Q2.

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    Tara Bancroft's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q1 2025

    Question

    Tara Bancroft from TD Cowen asked for a breakdown of revenue from new versus ongoing patients and inquired about any Q1 headwinds related to gross-to-net adjustments and reimbursement.

    Answer

    CEO Jeremy Bender stated that new versus ongoing patient dynamics are similar to the prior quarter and that total scripts and revenue are the key metrics. CCO Lauren Merendino attributed Q1 seasonality to holiday-related delays in scans, noting a strong rebound in new patient starts in April. COO & CFO Charles York confirmed the gross-to-net percentage remained in the 12-15% range, slightly higher due to a January price increase and typical Q1 co-pay assistance needs.

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    Tara Bancroft's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q4 2024

    Question

    Tara Bancroft inquired about the expected cadence of new patient starts for OJEMDA in the coming year, asking whether to anticipate an inflection point or more linear growth.

    Answer

    Chief Commercial Officer Lauren Merendino, prompted by CEO Jeremy Bender, stated that due to the slow-moving nature of pLGG, she anticipates continued steady growth in new patient starts rather than a single, dramatic inflection point. She emphasized that even after a physician decides to use OJEMDA, it can take time for a treatment decision to arise.

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    Tara Bancroft's questions to Ocular Therapeutix Inc (OCUL) leadership

    Tara Bancroft's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2025

    Question

    Tara Bancroft of TD Cowen asked for clarification on how the FDA might view the updated rescue criteria for the SOLAR trial when evaluating the primary endpoint, and how this differs from the previous criteria.

    Answer

    Pravin Dugel, Executive Chairman, President & CEO, reiterated that the modification to the rescue criteria was a strategic decision to better align the trial with real-world clinical practice and enhance adoptability. He stated there would be no change in how the FDA evaluates the primary endpoint, as the change was not an FDA requirement.

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    Tara Bancroft's questions to Ocular Therapeutix Inc (OCUL) leadership • Q3 2024

    Question

    Tara Bancroft questioned whether Ocular would provide regular updates on SOL-R enrollment progress now that it can accelerate and asked about the general expectations for how long enrollment might take.

    Answer

    President and CEO Dr. Pravin Dugel stated that updates on SOL-R enrollment will be provided 'as appropriate.' He emphasized the trial's momentum, noting a seamless transition and a large bolus of patients from SOL-1, and expressed confidence in the recruitment pace due to the trial's more familiar non-inferiority design.

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    Tara Bancroft's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2024

    Question

    Tara Bancroft sought clarification on the term 'generally acceptable' from the FDA's written response as mentioned in the press release. She also asked if management perceives any remaining risk to the two studies satisfying NDA requirements and what proactive measures are being taken to mitigate such risks.

    Answer

    Dr. Pravin Dugel, President and CEO, clarified that 'generally acceptable' is standard FDA terminology and the key message is the company's complete alignment with the agency, now confirmed in writing. He highlighted that this written response explicitly noted that a sham control is not recommended, which de-risks Ocular's studies as they do not use a sham, thereby validating their clinical development strategy.

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    Tara Bancroft's questions to TG Therapeutics Inc (TGTX) leadership

    Tara Bancroft's questions to TG Therapeutics Inc (TGTX) leadership • Q2 2025

    Question

    Tara Bancroft inquired about the full-year 2025 revenue guidance for BRIUMVI, noting that it implies a moderation in growth during the second half of the year, and asked for details on expected headwinds and tailwinds for Q3 and Q4.

    Answer

    Chief Commercial Officer Adam Waldman confirmed the company raised its full-year guidance. He explained that while summer seasonality is expected in Q3, stronger growth is anticipated from Q3 to Q4. Waldman attributed the overall guidance increase to better-than-expected new patient enrollments and strong patient persistence.

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    Tara Bancroft's questions to TG Therapeutics Inc (TGTX) leadership • Q1 2025

    Question

    Tara Bancroft inquired about the competitive landscape for Briumvi, particularly regarding new patient market share against OCREVUS and any signs of preferential uptake.

    Answer

    Chief Commercialization Officer Adam Waldman responded, stating that TG Therapeutics has seen 'zero impact' on Briumvi from competitors in the de novo patient segment. He highlighted that the first three months of the year were the highest ever for new patient enrollments and that the company continues to gain market share in the IV anti-CD20 segment, which is now believed to be above the 25% previously cited.

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    Tara Bancroft's questions to TG Therapeutics Inc (TGTX) leadership • Q3 2024

    Question

    Tara Bancroft from TD Cowen questioned if future growth would be steady or follow a seasonal cadence, and asked about the ideal volume and dosing interval being targeted for the subcutaneous BRIUMVI formulation.

    Answer

    Chief Commercialization Officer Adam Waldman acknowledged seasonal dynamics in the MS market but stated the company is poised for more growth, fueled by new investments. CEO Michael Weiss added that for the subcutaneous version, the minimum target for dosing frequency is every other month, with a goal of being as infrequent as possible.

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    Tara Bancroft's questions to Verona Pharma PLC (VRNA) leadership

    Tara Bancroft's questions to Verona Pharma PLC (VRNA) leadership • Q1 2025

    Question

    Tara Bancroft requested more color on the refill rates for patients who started Ohtuvayre six or more months ago and how this is expected to evolve. She also asked if Verona Pharma has the option or interest to repurchase the China rights from Nuance Pharma.

    Answer

    Chief Commercial Officer Christopher Martin explained that while it's early and the number of long-term patients is still growing, the company is very encouraged by persistency and refill rates. He noted that while typical COPD patients refill about six times a year, there is potential upside for Ohtuvayre due to its benefits and the company's 'white glove' distribution service. CEO David Zaccardelli stated that while an opportunity to repurchase China rights exists under certain conditions, it is not part of the current plan, and the collaboration with Nuance Pharma remains strong.

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    Tara Bancroft's questions to Verona Pharma PLC (VRNA) leadership • Q1 2025

    Question

    Tara Bancroft from TD Cowen asked for more details on refill rates for patients on Ohtuvayre for six months or more, the expected steady-state refill rate, and whether Verona has the option or interest in repurchasing the rights for China.

    Answer

    Christopher Martin, Chief Commercial Officer, noted that while it's early for long-term data, persistency and refill rates are very encouraging, with potential upside to the typical six fills per year in COPD. CEO David Zaccardelli stated that repurchasing China rights is not part of the current plan and is contingent on other factors, highlighting the strong ongoing collaboration with Nuance Pharma.

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    Tara Bancroft's questions to Lantheus Holdings Inc (LNTH) leadership

    Tara Bancroft's questions to Lantheus Holdings Inc (LNTH) leadership • Q1 2025

    Question

    Francis, on behalf of Tara Bancroft, asked for the specific impact of MUC-based pricing on revenue compared to other factors and sought confirmation on the percentage of patients affected by MUC.

    Answer

    President Paul Blanchfield clarified that MUC pricing impacts approximately 20% of patients, not 10%. He explained that it is difficult to isolate the MUC impact from competitive pricing and product availability, as they are all interconnected. He characterized the MUC impact as likely transitory as imaging sites grow accustomed to the new payment mechanics.

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    Tara Bancroft's questions to Lantheus Holdings Inc (LNTH) leadership • Q3 2024

    Question

    Tara Bancroft shifted focus to the Alzheimer's diagnostic pipeline, asking how the assets differentiate from current options and emerging blood tests, what the company's market outlook is, and if more details would be shared in 2025.

    Answer

    Chief Medical Officer Jeff Humphrey highlighted the assets' differentiation as second-generation agents with high sensitivity and low off-target binding, allowing for anatomical visualization that correlates with symptom severity. President Paul Blanchfield added that the U.S. market could reach $1.5 billion by the end of the decade, viewing blood tests as complementary and noting the pipeline leverages existing F-18 infrastructure.

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