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    Annabel Samimy • Stifel

    Annabel Samimy's questions to Trevi Therapeutics Inc (TRVI) leadership

    Annabel Samimy's questions to Trevi Therapeutics Inc (TRVI) leadership • Q2 2025

    Question

    Annabel Samimy of Stifel Financial Corp questioned the rationale for the parallel design in the non-IPF ILD study and commented on Haduvio's favorable tolerability and quality of life scores from the CORAL trial, asking if any changes were needed.

    Answer

    James Cassella, Chief Development Officer, explained the non-IPF ILD trial will have broad inclusion criteria based on fibrosis and cough, and the parallel design is suitable since proof-of-concept is established. He confirmed satisfaction with the CORAL trial's consistent tolerability profile and stated no significant changes are planned for the Phase 3 design, pending FDA discussions.

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    Annabel Samimy's questions to Trevi Therapeutics Inc (TRVI) leadership • Q1 2025

    Question

    Annabel Samimy asked about the CORAL trial's discontinuation rate, specifically what rate the study was powered for versus the actual observed rate, and questioned what management views as the biggest remaining risk for the IPF study.

    Answer

    Chief Development Officer Dr. James Cassella confirmed the study was powered for a 30% discontinuation rate, while the actual rate was under 10%. Executive Jennifer Good added that despite positive interim data, the trial's complexity, involving 60 sites across 10 countries, remains a key variable until the final data is unblinded.

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    Annabel Samimy's questions to Trevi Therapeutics Inc (TRVI) leadership • Q4 2024

    Question

    Annabel Samimy of Stifel asked about the efficacy observed at the 54mg dose in the RIVER trial, its comparison to the initial IPF trial, the potential for lower dosing in future studies to improve the AE profile, and whether AEs were dose-dependent. She also inquired about the inclusion criteria for the next RCC trial.

    Answer

    Executive Jennifer Good explained that the RIVER data suggests the effective dose for RCC is in the 27-54mg range, and the 108mg dose will likely not be needed, which provides flexibility for managing adverse events. She added that the team is even exploring doses below 27mg. For the next RCC trial, she stated it will target refractory patients but will no longer stratify by moderate versus severe cough counts.

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    Annabel Samimy's questions to Evolus Inc (EOLS) leadership

    Annabel Samimy's questions to Evolus Inc (EOLS) leadership • Q2 2025

    Question

    Annabel Samimy from Stifel Financial Corp. questioned the drivers behind reduced demand, probing whether it was consumer sentiment or competition, the cause of the sharp decline in the last two weeks of Q2, and the breakdown of Evolisse's launch revenue between initial stocking and pull-through.

    Answer

    President & CEO David Moatazedi attributed the slowdown to a high single-digit decline in market-wide procedural demand, which Evolus felt acutely in the final two weeks as top-tier accounts held back on large orders. He clarified this was a market-wide issue, not a competitive share loss. For Evolisse, he suggested the launch revenue was a "relatively even mix" of initial stocking and reorder pull-through.

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    Annabel Samimy's questions to Evolus Inc (EOLS) leadership • Q1 2025

    Question

    Annabel Samimy inquired about aesthetic market trends, asking whether the filler market's weakness is due to macroeconomic pressures or a negative consumer sentiment toward the word 'filler.' She also questioned the slowdown in the typically resilient neuromodulator market, the classification of neuromodulators regarding potential tariffs, and the intended use of capital from the recent debt refinancing.

    Answer

    CEO David Moatazedi stated the filler market pressure is a combination of reduced consumer spending and negative sentiment, which the 'Drop the F Word' campaign aims to counteract. He noted the toxin market saw a slight Q1 dip but expects it to avoid negative annual growth. CFO Sandra Beaver clarified that Jeuveau is currently classified as a pharmaceutical for import purposes, making it exempt from current tariffs. She also explained the new debt facility provides non-dilutive capital capacity for potential strategic growth initiatives, emphasizing the company's focus on capital efficiency.

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    Annabel Samimy's questions to Evolus Inc (EOLS) leadership • Q4 2024

    Question

    Annabel Samimy inquired about the challenging market conditions for U.S. facial injectables, the potential impact of GLP-1 weight-loss drugs on patient demand, and the performance of the new Club Evolus subscription model.

    Answer

    CEO David Moatazedi stated that Evolus is not observing the challenging market conditions mentioned by competitors, citing continued high single-digit growth in the toxin market and stable treatment intervals among its loyalty program members. He identified the GLP-1 patient trend as a significant tailwind for HA fillers, especially given Evolysse's unique label mentioning weight loss as a cause of wrinkles. Regarding the Club Evolus subscription, he noted positive early results from the initial pilot of ~100 accounts but prefers to wait for a full year of data before sharing specific metrics.

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    Annabel Samimy's questions to Evolus Inc (EOLS) leadership • Q3 2024

    Question

    Annabel Samimy of Stifel inquired about the strategy for leveraging Evolus's digital platform for the upcoming Evolysse filler launch, competitive pricing dynamics in the filler market, and the rationale for narrowing the full-year revenue guidance.

    Answer

    President and CEO David Moatazedi explained that the existing digital platform will be fully leveraged for Evolysse, capitalizing on the company's cash-pay model, and that the product will be priced competitively. CFO Sandra Beaver added that narrowing the guidance range in Q4 is standard practice to provide more clarity with only one quarter remaining and does not indicate any concern.

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    Annabel Samimy's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Annabel Samimy's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q2 2025

    Question

    Annabel Samimy of Stifel asked about the potential total market penetration for GA, referencing a competitor's goal, and whether patients are delaying treatment due to the co-pay funding gap.

    Answer

    CEO Dr. Cedric Francois noted that adopting physicians treat 30-50% of their GA patients with Cyfovri, suggesting a potential target. Speaking as a clinician, CMO Dr. Caroline Baumal confirmed that the funding gap is unfortunately causing some patients to be unable to start the long-term treatment.

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    Annabel Samimy's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q1 2025

    Question

    Annabel Samimy asked for more detail on the Q4 inventory build, questioning how much was driven by the competitor's regulatory issues and whether physician conversations have changed since the competitor's label update. She also requested a quantification of the inventory impact.

    Answer

    Executive Timothy Sullivan explained that the competitor's CRL in December led to a sharp increase in SYFOVRE demand, new patient share, and switches, all contributing to the inventory build. Executive David Acheson added that while the competitor's product is now more likely to be reimbursed, SYFOVRE's every-other-month dosing with high efficacy remains a powerful differentiator with both physicians and payers, which continues to drive business.

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    Annabel Samimy's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q4 2024

    Question

    Annabel Samimy from Stifel sought to reconcile SYFOVRE's >60% total market share with its ~50% new patient share and asked about the expected launch trajectory for EMPAVELI in C3G/MPGN.

    Answer

    CEO Dr. Cedric Francois and CMO Dr. Caroline Baumal explained the new patient share trend is positive and that the competitive field is now level, which favors SYFOVRE's superior long-term, flexible-dosing data. For C3G/MPGN, Dr. Francois reiterated the high unmet need and the significant market opportunity, as Apellis will likely only compete for about 20% of the total patient population.

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    Annabel Samimy's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q3 2024

    Question

    Annabel Samimy of Stifel asked about the dynamics of patient referrals, including patient severity, and whether the '6 conversations' needed to convert a physician becomes more challenging as less severe patients are referred.

    Answer

    CMO Dr. Caroline Baumal explained that they see a wide range of patients and that physician conversations now center on efficacy and dosing flexibility, bolstered by real-world data. COO Adam Townsend added that it takes 6-9 conversations to onboard a new physician and that their educational efforts with optometrists and ophthalmologists help prepare patients before they see a retina specialist. He noted access to physicians is not a problem.

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    Annabel Samimy's questions to Viking Therapeutics Inc (VKTX) leadership

    Annabel Samimy's questions to Viking Therapeutics Inc (VKTX) leadership • Q2 2025

    Question

    Annabel Samimy of Stifel asked for the rationale behind transitioning patients to maintenance dosing at the three-month mark in the planned study, given weight loss would still be ongoing. She also inquired about what Viking views as the most likely viable commercial doses for the oral formulation.

    Answer

    President & CEO Brian Lian clarified that the transition to maintenance happens after a titration period longer than three months; the maintenance evaluation itself lasts about three months. For oral doses, he noted that lower doses are attractive for maintenance but highlighted the 90mg-to-30mg step-down cohort as key. He also mentioned that falling peptide production costs might improve the feasibility of higher oral doses.

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    Annabel Samimy's questions to Viking Therapeutics Inc (VKTX) leadership • Q1 2025

    Question

    Annabel Samimy inquired about how the Phase III trial for injectable VK2735 will assess durability and whether a monthly dosing regimen would be incorporated. She also asked if the auto-injector must be integrated into the Phase III study.

    Answer

    Brian Lian, President and CEO, confirmed the auto-injector will be introduced into the Phase III program, which necessitates the planned bridging study. He stated that a monthly dosing regimen is not currently part of the Phase III protocols but could potentially be included in a future extension study, pending results from an initial trial evaluating the weekly-to-monthly transition.

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    Annabel Samimy's questions to Viking Therapeutics Inc (VKTX) leadership • Q4 2024

    Question

    Annabel Samimy questioned the broad dose range in the Phase II oral VENTURE trial, asking if the highest dose is a realistic target. She also requested an update on the status of manufacturing agreements.

    Answer

    CEO Brian Lian explained the dose range is to evaluate if lower doses show maturing efficacy over time. He noted the highest dose was deemed acceptable based on Phase I tolerability and the drug's slow accumulation. On manufacturing, he stated that Viking is making good progress on comprehensive agreements to support a substantial commercial launch.

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    Annabel Samimy's questions to Viking Therapeutics Inc (VKTX) leadership • Q3 2024

    Question

    Annabel Samimy asked about the potential for monthly dosing data for VK2735, its inclusion in the Phase III program, exploration of different oral dosing regimens, and the required infrastructure and personnel expansion for upcoming large-scale trials.

    Answer

    Executive Brian Lian stated that PK data supporting monthly dosing will be presented, but this regimen would likely be evaluated in a separate, stand-alone trial. Regarding infrastructure, he confirmed a significant, broad-based increase in staff across multiple departments, including regulatory, clinical operations, and manufacturing, to prepare for Phase III.

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    Annabel Samimy's questions to Altimmune Inc (ALT) leadership

    Annabel Samimy's questions to Altimmune Inc (ALT) leadership • Q1 2025

    Question

    Annabel Samimy of Stifel asked about the potential to shorten MASH development timelines in Phase 3, the FDA's evolving stance on biomarkers, and any recent changes in interactions with the agency.

    Answer

    CBO Ray Jordt stated that a 6-month readout and rapid enrollment could shorten the development path, a possibility they will discuss with the FDA. He noted that while biomarkers are gaining acceptance, biopsy endpoints are likely still required for approval. He reported no change in FDA interactions. CEO Dr. Vipin Garg added that Altimmune's large existing safety database might allow for a more efficient Phase 3 trial design.

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    Annabel Samimy's questions to Altimmune Inc (ALT) leadership • Q4 2024

    Question

    Annabel Samimy from Stifel Financial Corp. questioned what would define a competitive success for the IMPACT trial and sought commentary on the evolving NASH market landscape with competitors like semaglutide, Rezdiffra, and FGF21s. She also asked if exploratory endpoints would be released in the top-line data.

    Answer

    CEO Dr. Vipin Garg positioned pemvidutide as a complete solution for NASH by treating both the liver and obesity. CMO Dr. Scott Harris added that achieving statistical significance at 24 weeks would be a key differentiator from other incretins and that pemvidutide's weight loss benefit separates it from FGF21s and Rezdiffra. CFO Gregory Weaver confirmed they would aim to provide as much data as possible in the top-line readout.

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    Annabel Samimy's questions to Regenxbio Inc (RGNX) leadership

    Annabel Samimy's questions to Regenxbio Inc (RGNX) leadership • Q1 2025

    Question

    Annabel Samimy of Stifel questioned if the FDA's safety focus could create higher hurdles for gene therapies in non-life-threatening conditions like retinal disease and asked about the potential impact of political inquiries on newborn screening efforts.

    Answer

    Chief Medical Officer Dr. Steve Pakola explained that retinal programs follow a standard, not accelerated, approval path and that their compartmentalized delivery methods offer a strong safety profile. President and CEO Curran Simpson added that newborn screening efforts continue to be a priority driven at the state level with advocacy groups, independent of federal inquiries.

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    Annabel Samimy's questions to Regenxbio Inc (RGNX) leadership • Q4 2024

    Question

    Annabel Samimy of Stifel inquired about regulatory discussions for diabetic retinopathy (DR), asking about key differences between U.S. and ex-U.S. regulators. She also sought clarity on the upcoming DMD functional data update and whether the reported 50% pivotal trial enrollment includes patients from the Phase I/II study.

    Answer

    CEO Curran Simpson clarified that the upcoming DMD functional data will include longer follow-up on previously disclosed patients, new patient data from the Phase I/II cohort, and long-term data from dose level 1. He also confirmed the pivotal enrollment figure includes both new patients and eligible patients from the Phase I/II study. Chief Medical Officer Dr. Steve Pakola explained that for DR, the U.S. has a clear regulatory precedent using the DRSS scale, whereas this path is less established in Europe, necessitating further discussions with the EMA and in Japan.

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    Annabel Samimy's questions to Ligand Pharmaceuticals Inc (LGND) leadership

    Annabel Samimy's questions to Ligand Pharmaceuticals Inc (LGND) leadership • Q1 2025

    Question

    Annabel Samimy asked about Ligand's annual investment capacity and willingness to increase it to capitalize on the current market environment, and also inquired about future plans for the NitroCil platform beyond the ZELSUVMI launch.

    Answer

    CEO Todd Davis responded that Ligand would likely invest at an above-average pace this year given the opportunities, but will remain disciplined by adhering to diversification limits and internal bandwidth. Regarding the NitroCil platform, he explained it was a key part of the potential outsized return from the Novan special situation. The team is currently evaluating other therapies from the platform and will likely seek partners for their development, with an expectation of at least two commercial products emerging from it.

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    Annabel Samimy's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership

    Annabel Samimy's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q1 2025

    Question

    Annabel Samimy of Stifel inquired about the growth prospects for Rylaze, specifically asking about the expected pace of adoption in the adolescent and young adult (AYA) market and the timeline for it to gain critical mass and return the product to growth.

    Answer

    Renée Galá, President and COO, acknowledged that educating adult treaters in the AYA segment takes time but noted they are seeing momentum. She expressed confidence that revenue would normalize in the second quarter of 2025 as the impact of pediatric protocol changes subsides. CFO Phil Johnson added that Q1 2025 sales were also impacted by having one fewer shipping week compared to Q1 2024.

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    Annabel Samimy's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q4 2024

    Question

    Annabel Samimy from Stifel inquired about a slight compression in Zepzelca sales in Q4 and asked about the 2025 outlook, including the possibility of securing NCCN guideline or compendia listings for the first-line maintenance indication ahead of the formal sNDA approval.

    Answer

    Renée Galá, President and COO, attributed the Q4 sales dynamic partly to fewer distributor buying days, a pattern also seen in the prior year, while noting the product's 11% full-year growth. For 2025, she confirmed Jazz will not promote the first-line indication before approval but is working diligently to get the data published, which is a key step toward potential inclusion in treatment guidelines.

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    Annabel Samimy's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q4 2024

    Question

    Annabel Samimy of Stifel asked about a potential Q4 sales compression for Zepzelca and its 2025 outlook, including the possibility of compendia listing ahead of a formal sNDA approval.

    Answer

    President & COO Renée Galá attributed the Q3 to Q4 dynamic partly to fewer distributor buying days, a pattern also seen in 2023. She noted Zepzelca grew 11% for the full year. For 2025, she stated the company will work diligently to get data into a peer-reviewed journal to support potential treatment guideline inclusion ahead of the sNDA approval.

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    Annabel Samimy's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q3 2024

    Question

    An analyst on behalf of Annabel Samimy asked if the positive first-line maintenance data for Zepzelca provides a clearer view of its peak opportunity, how physicians might adopt it, and whether it would cannibalize the second-line setting.

    Answer

    President and COO Renée Galá and EVP, Global Head of R&D Robert Iannone both responded. They believe the data is 'practice changing' and will drive significant uptake upon approval. While first-line use would preclude second-line use, the move into a larger patient population with longer treatment duration is expected to increase the overall revenue opportunity for Zepzelca.

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    Annabel Samimy's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q3 2024

    Question

    An analyst on behalf of Annabel Samimy at Stifel asked about the peak sales opportunity for Zepzelca following its first-line maintenance data, physician adoption rates, and potential cannibalization of the second-line market.

    Answer

    President and COO Renée Galá and EVP, Global Head of R&D, Rob Iannone, both responded. They believe the data is practice-changing and will significantly increase the addressable market by reaching a larger patient population for a longer duration. They clarified that while patients treated in the first line would not receive Zepzelca again in the second line, this preemptive use ultimately expands the drug's reach and overall revenue potential.

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    Annabel Samimy's questions to Mineralys Therapeutics Inc (MLYS) leadership

    Annabel Samimy's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q4 2024

    Question

    Annabel Samimy of Stifel inquired about payer coverage expectations based on different ranges of blood pressure reduction and asked about the size of the third and fourth-line hypertension market and how that affects the drug's opportunity.

    Answer

    Executive Jon Congleton stated that based on four separate payer research projects, the company is 'very bullish' on gaining access. He explained that a base case of an 8-10 millimeter mercury improvement is expected to allow them to 'own' the fourth-line resistant hypertension space and is also viewed favorably by payers for targeted third-line use, such as in patients with a BMI over 30.

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    Annabel Samimy's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q3 2024

    Question

    Annabel Samimy of Stifel questioned the sufficiency of a 6-week primary endpoint for the Launch-HTN trial given real-world variability. She also asked about the potential to see a statistically significant separation between obese and non-obese cohorts and whether to expect a clear dose-response between the 50mg and 100mg arms.

    Answer

    Executive Jon Congleton expressed confidence in the 6-week endpoint, citing Target-HTN data where most of the effect was seen by week 4. He noted the 6-week endpoint was chosen to increase statistical power for subset analyses, such as the obese cohort. CMO Dr. David Rodman added that the 50mg to 100mg titration is designed to get individual patients to an effective dose, which could be driven by either drug exposure or individual biology, rather than demonstrating a classic dose-response curve.

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