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    Paul Choi • Goldman Sachs

    Paul Choi's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Paul Choi's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q2 2025

    Question

    Paul Choi from Goldman Sachs inquired about the expected dose-response for the 15mg and 25mg doses in the Phase III epilepsy trial and the filing strategy for these doses. He also asked if Xenon would explore combining its Nav1.7 inhibitor with a Nav1.8 inhibitor post-proof of concept.

    Answer

    President and CEO Ian Mortimer stated that while long-term combinations in pain are interesting, the immediate focus is on single-agent proof of concept. Regarding dosing, both Mortimer and Chief Medical Officer Christopher Kenney confirmed they expect a dose-response and plan to file with multiple doses to provide flexibility for physicians, a strategy consistent with FDA discussions. Kenney added that the study is well-powered for both dose levels.

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    Paul Choi's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q1 2025

    Question

    An analyst on for Paul Choi asked about the trial design for bipolar depression (BPD), specifically whether the company plans to stratify patients by BPD Type 1 and Type 2 to enhance the signal-to-noise ratio.

    Answer

    Chief Medical Officer Dr. Chris Kenney confirmed the studies will enroll a mix of Bipolar I and II patients. He acknowledged the validity of the question, stating that stratification is something the company is 'definitely seriously considering' given the potential for different responses and an uneven mix of patient types. More details on the trial design will be shared when the first study initiates mid-year.

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    Paul Choi's questions to Dynavax Technologies Corp (DVAX) leadership

    Paul Choi's questions to Dynavax Technologies Corp (DVAX) leadership • Q2 2025

    Question

    Paul Choi of Goldman Sachs asked about the plague vaccine program's reliance on government funding and the potential impact of seasonality on patient enrollment for the future Lyme disease clinical trials.

    Answer

    CEO Ryan Spencer confirmed the plague program is fully aligned with and dependent on the U.S. Department of Defense, noting that funding is already secured through the first half of 2027. Regarding the Lyme disease program, he acknowledged that seasonality will be a critical factor in designing the future efficacy trial to demonstrate durability, although near-term studies will focus on safety and immunogenicity.

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    Paul Choi's questions to Dynavax Technologies Corp (DVAX) leadership • Q4 2024

    Question

    An analyst on behalf of Paul Choi asked about the drivers behind the strong Q1 start for HEPLISAV-B, how that strength is reflected in the full-year guidance, and the expected timing and cadence of the guided increase in 2025 operating expenses.

    Answer

    CEO Ryan Spencer attributed the strong Q1 start to retail pharmacies pivoting to non-respiratory vaccine initiatives earlier than in the previous year, which supports the company's annual guidance. CFO Kelly MacDonald explained the high-teens percentage increase in R&D expenses is activity-based and will be driven by a full year of costs for the DoD plague program and ongoing expenses for the Phase I/II shingles study through the first three quarters.

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    Paul Choi's questions to PTC Therapeutics Inc (PTCT) leadership

    Paul Choi's questions to PTC Therapeutics Inc (PTCT) leadership • Q2 2025

    Question

    Daniel Ni, on behalf of Paul Choi at Goldman Sachs, asked about the pricing assumption for Sefiance in Germany after the initial six-month free-pricing period concludes.

    Answer

    CBO Eric Pauwels explained that PTC's global strategy is to maintain a very narrow pricing corridor, with U.S. and German launch prices already set closely. In Germany, after the six-month free-pricing period, the company will enter negotiations following a medical benefit assessment. He expressed optimism that the clinical data, real-world evidence gathered in the interim, and KOL support will help maintain a price within that narrow corridor through the 12-month AMNOG process.

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    Paul Choi's questions to PTC Therapeutics Inc (PTCT) leadership • Q1 2025

    Question

    An analyst on behalf of Paul Choi asked for any feedback from the FDA regarding the use of natural history data from the FACOMS registry for the vatiquinone approval submission.

    Answer

    CEO Dr. Matthew Klein explained that the comparison to the FACOMS natural history database is a key piece of confirmatory evidence. He noted the FDA is highly familiar with this robust registry, as it was used to support the SKYCLARYS approval, and it is considered a model for how such data can support regulatory decision-making.

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    Paul Choi's questions to PTC Therapeutics Inc (PTCT) leadership • Q3 2024

    Question

    Paul Choi of Goldman Sachs inquired about payer feedback on vatiquinone, its potential pricing relative to Skyclarys, and the company's appetite for business development given its strong cash position.

    Answer

    CEO Matthew Klein stated it's early for specific payer discussions on vatiquinone but emphasized its differentiated profile and the clear unmet need in pediatric patients. Regarding business development, he said the company's strong cash balance supports its planned launches while allowing it to remain opportunistic for strategic assets that could fill out its ex-U.S. portfolio or fit its existing infrastructure.

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    Paul Choi's questions to Ascendis Pharma A/S (ASND) leadership

    Paul Choi's questions to Ascendis Pharma A/S (ASND) leadership • Q2 2025

    Question

    Paul Choi of Goldman Sachs inquired about the timeline for submitting data to the FDA for the 60mcg dose of Yorvipath and asked what portion of the patient population this higher dose would potentially address.

    Answer

    President & CEO Jan Møller Mikkelsen confirmed a clear need for a higher dose. He described the newly initiated trial as small and short (26 weeks) and stated the company will file for approval as quickly as possible. He indicated an unmet need exists, as some patients currently require supplementation or may be receiving higher doses through off-label means.

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    Paul Choi's questions to Ascendis Pharma A/S (ASND) leadership • Q1 2025

    Question

    Paul Choi asked for color on the etiology of patients receiving YORVIPATH, specifically the mix of post-surgical versus genetic causes. He also inquired about development plans for TransCon CNP in the youngest patient population (birth to three years old).

    Answer

    CEO Jan Mikkelsen and Chief Medical Officer Aimee Shu clarified that the commercial patient mix mirrors the general hypoparathyroidism population and their clinical trial demographics, with approximately 80% being post-surgical and 20% from genetic or other causes. They noted that clinicians are prescribing YORVIPATH to all types of hypopara patients, as the label is not restrictive based on etiology.

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    Paul Choi's questions to Ascendis Pharma A/S (ASND) leadership • Q2 2024

    Question

    Paul Choi (on behalf of Kyuwon Choi) asked about the scope of the SKYTROFA payer contract true-up and whether the new Royalty Pharma deal represents the final capital needed before reaching breakeven.

    Answer

    President and CEO Jan Mikkelsen addressed the first question, explaining that the new payer contracts were implemented during Q1 and Q2, and the U.S. coverage is now 'reset.' He expects the resulting gross-to-net percentage to remain stable for the second half of 2024 and for the next five years, suggesting the issue is resolved. The second question regarding the financing was not directly answered before the call moved to the next questioner.

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    Paul Choi's questions to Urogen Pharma Ltd (URGN) leadership

    Paul Choi's questions to Urogen Pharma Ltd (URGN) leadership • Q2 2025

    Question

    Paul Choi of Goldman Sachs inquired if UGN-103 could address different patient segments than ZYSTIRI and asked about the role of non-physicians, like nurse practitioners, in administering the product.

    Answer

    CMO Mark Schoenberg and CEO Liz Barrett confirmed UGN-103 is being evaluated in the same population as ZYSTIRI to replicate the ENVISION trial, though future life cycle studies will explore other populations. CCO David Lin added that while physicians will oversee the process initially, they expect administration to eventually be handled by nurses specializing in intravesical therapies, and UroGen's sales approach targets the entire office staff.

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    Paul Choi's questions to Urogen Pharma Ltd (URGN) leadership • Q1 2025

    Question

    Paul Choi asked if the 340B utilization trend seen with JELMYTO is expected for UGN-102 and inquired about the internal bar for the go/no-go decision on advancing the UGN-301 program.

    Answer

    CEO Liz Barrett stated they expect 340B discounts to be less significant for UGN-102 over time due to a larger community-based business mix. For UGN-301, Chief Medical Officer Dr. Mark Schoenberg explained that as a Phase I trial, the focus is on safety, but they are encouraged by early responses and will assess durability before making a decision later in the year. Liz Barrett added that the efficacy bar is now higher and they will be critical before proceeding, also considering their UGN-501 asset.

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    Paul Choi's questions to Urogen Pharma Ltd (URGN) leadership • Q3 2024

    Question

    On behalf of Paul Choi, an analyst asked for an overview of how the commercial launch process for UGN-102 will be improved based on learnings from challenges with JELMYTO's administration, reimbursement, and access.

    Answer

    CCO David Lin explained that they will apply learnings by immediately pairing clinical conviction with operational and financial support. President and CEO Liz Barrett added that UGN-102's launch will be fundamentally different and easier, as it treats a more common disease and its administration is simpler, avoiding the 'heavy lift' associated with JELMYTO.

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    Paul Choi's questions to HUTCHMED (China) Ltd (HCM) leadership

    Paul Choi's questions to HUTCHMED (China) Ltd (HCM) leadership • H1 2025

    Question

    Paul Choi of Goldman Sachs inquired about the potential impact of economic sensitivity on end-user demand for HUTCHMED's oncology products in China. He also asked for the potential timing for the next-generation SYK inhibitor to enter clinical trials, particularly in the context of partnering.

    Answer

    CEO Weiguo Su addressed the questions, expressing confidence in a second-half commercial recovery in China despite market turbulence, citing strong performance momentum in the past three months. Regarding the next-generation SYK inhibitor, Dr. Su projected a rapid development timeline, with a potential IND submission in Q2 of the following year. He noted its high probability of success makes it a very attractive out-licensing or co-development opportunity, which the company hopes to secure by the time it enters the clinic.

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    Paul Choi's questions to Regenxbio Inc (RGNX) leadership

    Paul Choi's questions to Regenxbio Inc (RGNX) leadership • Q2 2025

    Question

    Paul Choi asked about the company's confidence in the DMD program's regulatory path in the absence of a permanent CBER head and how it is thinking about long-term pricing for its retinal products given downward pressure on VEGF reimbursement.

    Answer

    President & CEO Curran Simpson stated it is too early to comment on retinal pricing strategy, as those discussions with AbbVie will occur closer to data readouts. On the FDA, he expressed confidence, noting the pivotal protocol was reviewed by a team that remains largely intact. He added that continued enrollment into the confirmatory study provides flexibility to adjust to any new regulatory feedback.

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    Paul Choi's questions to Vir Biotechnology Inc (VIR) leadership

    Paul Choi's questions to Vir Biotechnology Inc (VIR) leadership • Q2 2025

    Question

    Daniel, on behalf of Paul Choi from Goldman Sachs, asked if there would be additional data cuts from the Phase 2 SOLSTICE study for HDV and whether the next VIR-5500 (PSMA) update would include PFS data or radiology-based measurements.

    Answer

    EVP & Chief Medical Officer Dr. Mark Eisner confirmed that Vir plans to provide a complete 48-week data update from the SOLSTICE study by the end of the year. For the next VIR-5500 data cut, he stated that while guidance on timing is not yet available, the company aims for a meaningful update that will provide clear evidence of dose response, depth, and durability of PSA responses and other measures.

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    Paul Choi's questions to BridgeBio Pharma Inc (BBIO) leadership

    Paul Choi's questions to BridgeBio Pharma Inc (BBIO) leadership • Q2 2025

    Question

    Paul Choi from Goldman Sachs inquired about the potential for clinical success with incaleret in ADH1 to translate to the broader hypoparathyroidism indication, particularly regarding how responder rates might compare to other therapies.

    Answer

    COO Ananth Sridhar stated that a positive ADH1 study would significantly de-risk the hypoparathyroidism program, with key read-throughs on safety and the ability to rapidly normalize calcium levels. He highlighted upcoming data showing 80% of hypoparathyroidism patients achieved normalization and noted key differentiators for incaleret: its oral formulation, potential to normalize urine calcium, and avoidance of long-term bone resorptive effects.

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    Paul Choi's questions to BridgeBio Pharma Inc (BBIO) leadership • Q1 2025

    Question

    Paul Choi of Goldman Sachs posed a policy question regarding the potential impact of tariffs on BridgeBio's business and profitability as Attruby sales scale in the U.S. and ex-U.S. royalties increase.

    Answer

    CFO Tom Trimarchi stated that the impact from tariffs is expected to be 'very, very minor.' He explained this is because Attruby is manufactured in the U.S., the company is American, and its intellectual property is domiciled in the U.S., minimizing exposure to international trade disputes and tariffs.

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    Paul Choi's questions to Amarin Corporation PLC (AMRN) leadership

    Paul Choi's questions to Amarin Corporation PLC (AMRN) leadership • Q2 2025

    Question

    Paul Choi of Goldman Sachs inquired about Amarin's U.S. formulary negotiation outlook for 2026, the strategic role of a potential authorized generic, and what metrics investors should use to track the progress of the new Recordati partnership in Europe.

    Answer

    CEO Aaron Berg stated that Amarin expects to maintain its exclusive formulary positions in the U.S. through 2025, with more clarity on 2026 coming by year-end. He explained that launching an authorized generic is not yet optimal as the branded product continues to compete effectively. Regarding the Recordati partnership, Berg noted that the transition is underway and full commercial control will be handed over by the end of 2025. The company will report on European end-market demand as it develops and will continue to provide quarterly financial results.

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    Paul Choi's questions to Amarin Corporation PLC (AMRN) leadership • Q4 2024

    Question

    On behalf of Paul Choi, an associate asked for more detail on the drivers of revenue growth in the 'rest of the world' segment and requested a more specific geographical breakdown of the contributions.

    Answer

    President and CEO Aaron Berg explained that growth in the rest of the world is still in its early stages and is driven by the efforts of regional partners. He highlighted recent progress, including launches in China (EddingPharm) and Australia (CSL Seqirus), and expanded public access in Canada (HLS). Berg noted that it takes time to establish medical advocacy and secure reimbursement in each market and did not provide a specific numerical breakdown, emphasizing the foundational work being done.

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    Paul Choi's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership

    Paul Choi's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership • Q2 2025

    Question

    Paul Choi from Goldman Sachs questioned the company's plans for expanding the sales force or using direct-to-consumer (DTC) marketing to drive Arcalis growth, and also asked about the anticipated administration setting for KPL-387 (in-office vs. self-administered).

    Answer

    CEO Sanj Patel noted that the company continuously analyzes sales force size and is heavily focused on leveraging digital marketing and new technologies like AI for patient identification. EVP & CCO Ross Moat added that KPL-387's target monthly profile aligns well with at-home, outpatient administration, similar to Arcalis, and they do not foresee a substantial need for in-hospital use.

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    Paul Choi's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership • Q3 2024

    Question

    Paul Choi inquired about physician awareness of ARCALYST for first-recurrence patients in the context of treatment guidelines and asked for an update on the enrollment timeline for the abiprubart Phase IIb study.

    Answer

    Chief Medical Officer John Paolini explained that while formal guidelines predate ARCALYST, an evidence-based approach is driving its use as a second-line therapy after NSAIDs and colchicine fail, which often occurs at the first recurrence. Regarding the abiprubart study in Sjögren’s Disease, he confirmed it is actively enrolling and dosing patients but did not provide specific guidance on enrollment timelines.

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    Paul Choi's questions to Lantheus Holdings Inc (LNTH) leadership

    Paul Choi's questions to Lantheus Holdings Inc (LNTH) leadership • Q1 2025

    Question

    Daniel, on behalf of Paul Choi, asked about the likelihood of PYLARIFY revenue transitioning to ASP-based pricing and inquired about the current growth trends in the PET scan market for Alzheimer's disease.

    Answer

    CEO Brian Markison and CCO Amanda Morgan described the potential shift to ASP as 'murky' but noted conversations with CMS are ongoing. President Paul Blanchfield highlighted the long-term PSMA PET market potential of $3.5B by 2030 and noted 'very robust growth' in claims data for Alzheimer's PET scans, expressing optimism for the company's combined portfolio in that space.

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    Paul Choi's questions to Arvinas Inc (ARVN) leadership

    Paul Choi's questions to Arvinas Inc (ARVN) leadership • Q1 2025

    Question

    Paul Choi asked about any remaining gating items before the pre-NDA meeting for vepdegestrant and the expected timing for the next data update from the LRRK2 program.

    Answer

    CMO Noah Berkowitz confirmed that the pre-NDA meeting with the FDA has already taken place, and the company has a clear path to move forward with its submission. For the LRRK2 program, he guided that the next data update will be later in the year, likely from the single ascending dose (SAD) patient cohort, as multiple ascending dose (MAD) data may not be ready in time.

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    Paul Choi's questions to Arvinas Inc (ARVN) leadership • Q4 2024

    Question

    Paul Choi asked what initial clinical data from ARV-393 would be needed to support expansion into more challenging populations, such as post-stem cell transplant or elderly patients. He also sought confirmation on the venue for the initial Phase I data presentation (EHA or ASH).

    Answer

    Chief Medical Officer Noah Berkowitz noted it was premature to comment on specific expansion populations, though combination therapies are a likely path forward. Chief Scientific Officer Angela Cacace added that they are preclinically evaluating ARV-393 in post-CAR-T refractory models. Dr. Berkowitz declined to provide guidance on the specific conference for the data release.

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