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    Nicole Germino • Truist Securities

    Nicole Germino's questions to Y-mAbs Therapeutics Inc (YMAB) leadership

    Nicole Germino's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q1 2025

    Question

    Nicole Germino inquired about the revenue dynamics for DANYELZA between the U.S. and ex-U.S. markets, the factors driving performance, and the competitive switching dynamics in the U.S.

    Answer

    DANYELZA Business Unit Head Doug Gentilcore noted steady ex-U.S. growth and a recent uptick in U.S. enrollments after a slow start to the quarter. CEO Michael Rossi confirmed the U.S./ex-U.S. revenue split remains around 70/30 to 80/20 and stated the strategy to gain market share involves penetrating new large accounts, supported by a new clinical trial designed to increase physician experience with the product.

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    Nicole Germino's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q4 2024

    Question

    Nicole Germino of Truist asked if the bridging study for the GD2-SADA Trial 1001 would delay the start of Part B and requested a reminder of the timelines and expectations for Parts B and C of the trial.

    Answer

    Head of the Radiopharmaceuticals Business Unit, Natalie Tucker, explained that the bridging study is anticipated to start in early 2026 and should be relatively quick as it involves fewer patients and is focused on testing molecule optimization. She noted that Part B, with an anticipated 12 patients, should also be quicker than Part A, partly due to PET-directed patient selection. Detailed timelines for Part C will be announced after more data from Part B is available.

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    Nicole Germino's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q3 2024

    Question

    Nicole Germino asked for more details on the SADA platform's dosimetry, including expected organ accumulation and acceptable lutetium levels, and also inquired about the company's target selection strategy and criteria.

    Answer

    President and CEO Michael Rossi stated that based on the drug's elimination pathway, the highest off-tumor accumulation is expected in the kidneys and bladder. Chief Medical Officer Dr. Vignesh Rajah added that while they are evaluating dosimetry in all organs, they have not observed any early safety issues or dose-limiting toxicities. Regarding target selection, Rossi explained that the company is currently working through a list based on criteria including receptor modulation, unmet need, and commercial potential, with a full strategy to be outlined in early 2025.

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    Nicole Germino's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q2 2024

    Question

    Nicole Germino of Truist Securities asked for details on the SADA program's data milestones, the timeline for potential efficacy data from Part B, and how reimbursement might work for the novel two-part administration of protein and radioisotope.

    Answer

    President and CEO Michael Rossi clarified that SADA's Part A is designed for safety, not efficacy, with a focus on determining the optimal protein dose and timing interval before moving to Part B. Regarding reimbursement, he explained that while the company is exploring options, the primary strategic driver is to improve treatment efficiency and patient access, not a specific reimbursement model.

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    Nicole Germino's questions to Insmed Inc (INSM) leadership

    Nicole Germino's questions to Insmed Inc (INSM) leadership • Q1 2025

    Question

    Nicole Germino asked if the CRS without nasal polyps trial is enriching for high neutrophil counts and whether the CT scan and two-exacerbation criteria would be on the Brensocatib label.

    Answer

    CMO Martina Flammer clarified that the trial caps eosinophil counts but does not enrich for neutrophils, as analysis of the ASPEN study showed no difference in efficacy based on eosinophil levels. CEO William Lewis stated that the diagnostic and exacerbation criteria are not expected on the label itself but will be the basis for market access requirements.

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    Nicole Germino's questions to Insmed Inc (INSM) leadership • Q1 2025

    Question

    Nicole Germino asked if the CRS trial is enriching for patients with high neutrophil levels and whether the two-exacerbation criteria and CT scan will be on the Brensocatib label.

    Answer

    CMO Martina Flammer clarified the BiRCh trial enrolls patients with eosinophil counts up to 750, capturing the vast majority of the CRS without nasal polyps population. CEO William Lewis added that based on the ASPEN analysis, stratification by eosinophil count was removed, increasing the study's statistical power. He also stated that the exacerbation and CT scan criteria are not expected on the label but will likely be market access requirements.

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    Nicole Germino's questions to Insmed Inc (INSM) leadership • Q4 2024

    Question

    Nicole Germino asked about the sales force distribution between academic and community settings for the brensocatib launch and what percentage of the patient population was represented by trial sites.

    Answer

    CEO Will Lewis confirmed the expanded sales force can cover every pulmonologist in the U.S., with a significant educational effort aimed at the community level. CMO Martina Flammer added that there is now a better understanding of the role of inflammation in the disease. Lewis reiterated that the initial target market is the ~250,000 diagnosed patients with two or more exacerbations.

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    Nicole Germino's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Nicole Germino from Truist Securities asked about the market opportunity for brensocatib in chronic rhinosinusitis (CRS) without nasal polyps, including the target patient population and physician audience. She also sought confirmation on whether both brensocatib doses would be filed for bronchiectasis.

    Answer

    CEO Will Lewis characterized the CRS without nasal polyps opportunity as "very, very substantial," noting a U.S. patient population of over 26 million. He said Insmed is initially targeting an incident population of 400,000 patients annually who are eligible for or have had repeat surgeries. He also confirmed that Insmed intends to file data for both the 10mg and 40mg doses of brensocatib, with the final approval decision resting with the FDA.

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    Nicole Germino's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Nicole Germino asked about the market size for brensocatib in chronic rhinosinusitis (CRS) without nasal polyps and whether both doses of brensocatib for bronchiectasis would be included in the regulatory filing.

    Answer

    CEO Will Lewis described CRS without nasal polyps as a very substantial opportunity, with over 26 million U.S. patients and an initial target of 400,000 incident patients per year who are eligible for surgery. He also confirmed that Insmed intends to file data for both the 10mg and 25mg doses of brensocatib, with the final decision on approval resting with the FDA.

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    Nicole Germino's questions to Gilead Sciences Inc (GILD) leadership

    Nicole Germino's questions to Gilead Sciences Inc (GILD) leadership • Q3 2024

    Question

    Nicole Germino from Truist Securities, on for Asthika Goonewardene, asked about the IMAGINE-3 study for anito-cel, inquiring how many of the 130 clinical trial sites are actively enrolling patients and if the therapy is expected to be used in an outpatient setting.

    Answer

    An executive, likely EVP of Kite Cindy Perettie, responded that while the company does not disclose the specific number of recruiting sites, the team is working hard to activate all of them. She affirmed the belief that anito-cel has an outpatient profile, based on its ICANS and CRS rates, and noted that the Phase III program is designed to generate data specifically in that setting.

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