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    Brandon Folkes • H.C. Wainwright & Co.

    Brandon Folkes's questions to Omeros Corp (OMER) leadership

    Brandon Folkes's questions to Omeros Corp (OMER) leadership • Q2 2025

    Question

    Brandon Folkes of H.C. Wainwright & Co. questioned the expected timeline from a potential December approval to the commercial launch of narsoplimab. He also asked about inventory levels and whether a significant inventory build, similar to a prior PDUFA cycle, should be modeled into R&D spending.

    Answer

    Gregory Demopulos, Founder, Chairman, CEO & President, stated that a December approval would lead to a Q1 launch. Nadia Dac, CCO, detailed that the field team would be trained and deployed immediately upon approval to drive awareness. David Borges, VP of Finance, Chief Accounting Officer & Treasurer, confirmed that Omeros has adequate supply for the first several years of launch, indicating a strong inventory position.

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    Brandon Folkes's questions to Omeros Corp (OMER) leadership • Q4 2024

    Question

    Brandon Folkes of Rodman & Renshaw inquired about the long-term strategic vision for Omeros, particularly its approach to commercialization versus partnerships for its broad pipeline, including narsoplimab and zaltenibart.

    Answer

    Chairman and CEO Gregory Demopulos outlined the strategy, stating Omeros plans to launch narsoplimab independently in the U.S. while seeking ex-U.S. partners for both narsoplimab and zaltenibart. He expressed high confidence in the approval prospects for both drugs, referencing the company's successful commercialization of Omidria. Dr. Demopulos emphasized that Omeros is moving back to being a commercial entity, supported by a deep pipeline that includes promising oncology and infectious disease programs.

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    Brandon Folkes's questions to Zevra Therapeutics Inc (ZVRA) leadership

    Brandon Folkes's questions to Zevra Therapeutics Inc (ZVRA) leadership • Q2 2025

    Question

    Brandon Folkes of H.C. Wainwright & Co. asked about the medical specialties contributing most to new Myclifa patient enrollments in the U.S. and the dynamics of converting European Expanded Access Program (EAP) patients upon potential approval.

    Answer

    President and CEO Neil McFarlane highlighted the 26% quarter-over-quarter revenue growth for Myclifa, driven by strong patient pull-through from the 129 total enrollment forms. Chief Commercial Officer Joshua Schafer specified that prescribers include neurologists, pediatricians, medical geneticists, and an emerging group of psychiatrists. Regarding Europe, McFarlane noted the EAP has grown to 89 patients and expressed confidence that the durability of these patients on therapy bodes well for future conversions once country-by-country reimbursement is secured.

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    Brandon Folkes's questions to ANI Pharmaceuticals Inc (ANIP) leadership

    Brandon Folkes's questions to ANI Pharmaceuticals Inc (ANIP) leadership • Q2 2025

    Question

    Brandon Folkes asked how management views Cortrophin's market share potential as the overall market expands and whether it could achieve equal or dominant share at its peak. He also requested more granularity on the factors influencing R&D spending going forward.

    Answer

    President, Director & CEO Nikhil Lalwani stated that the company's focus is on growing the overall ACTH market and getting Cortrophin to appropriate patients, rather than on a specific market share target. SVP & CFO Stephen Carey explained that R&D spending can be variable quarter-to-quarter, with Q2 being higher due to the New Day trial, but affirmed the company's commitment to continued investment in R&D to drive long-term growth.

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    Brandon Folkes's questions to Trevi Therapeutics Inc (TRVI) leadership

    Brandon Folkes's questions to Trevi Therapeutics Inc (TRVI) leadership • Q2 2025

    Question

    Brandon Folkes from H.C. Wainwright & Co. inquired about the potential commercial impact of drug scheduling on prescribing habits in non-IPF ILD and whether negative results from the respiratory depression study could affect DEA scheduling.

    Answer

    Chief Commercial Officer Farrell Simon stated that based on market research, they do not anticipate scheduling to be a barrier for pulmonologists in the non-IPF ILD setting. Chief Development Officer James Cassella clarified that the respiratory study is for safety characterization and is not expected to impact DEA scheduling, which is driven by abuse liability potential.

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    Brandon Folkes's questions to Trevi Therapeutics Inc (TRVI) leadership • Q4 2024

    Question

    Brandon Folkes of Rodman & Renshaw asked for the scientific rationale behind the potential for different placebo response rates in IPF chronic cough studies compared to RCC studies.

    Answer

    Executive Jennifer Good acknowledged that the reason for differing placebo rates isn't definitively known but speculated it could be due to the different types of clinical sites used. RCC studies are often conducted in highly specialized cough centers, whereas IPF trials may involve a broader range of general IPF centers. She confirmed that for future parallel-arm studies, they will conservatively plan for higher placebo rates.

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    Brandon Folkes's questions to Trevi Therapeutics Inc (TRVI) leadership • Q3 2024

    Question

    Brandon Folkes from Rodman & Renshaw requested an update on the timing for the TIDAL respiratory physiology study and sought confirmation of the company's commitment to the study, especially with the arrival of the new Chief Development Officer.

    Answer

    CEO Jennifer Good confirmed the TIDAL study is currently enrolling and the data is needed for the end-of-Phase II meeting for IPF in the second half of 2025. The study's purpose is to inform the Phase III patient population definition, specifically regarding patients with sleep-disordered breathing. CDO Dr. James Cassella affirmed he has no different thoughts and sees it as an informative study for future decisions.

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    Brandon Folkes's questions to MannKind Corp (MNKD) leadership

    Brandon Folkes's questions to MannKind Corp (MNKD) leadership • Q2 2025

    Question

    Brandon Folkes from H.C. Wainwright & Co. asked about the current typical Afrezza patient profile, the impact of recent data on prescribing habits, and the strategy for expanding the sales footprint ahead of a potential pediatric launch.

    Answer

    CEO Michael Castagna noted a slight pivot towards Type 1 diabetes patients, with the 4-unit strength growing faster. Dominic Marasco, President of the Endocrine Business Unit, added that the strategy involves increasing unique prescribers and enhancing scientific engagement. For the pediatric launch, Castagna explained the expansion is necessary to increase share of voice and target academic centers with a dedicated team.

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    Brandon Folkes's questions to MannKind Corp (MNKD) leadership • Q4 2024

    Question

    Brandon Folkes from Rodman & Renshaw Research asked about the potential for a manufacturing revenue component for MannKind if the TETON trial is successful and the timeline for Afrezza reaching a $200 million-plus sales run rate.

    Answer

    Executive Michael Castagna confirmed that MannKind is expanding its manufacturing capacity and would be prepared to handle increased supply orders for TYVASO DPI, which would boost collaboration services revenue. He projected that Afrezza could reach its growth targets by achieving a 10% market share in pediatrics within 12-24 months post-launch, which, combined with adult sales, would create a major inflection.

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    Brandon Folkes's questions to MannKind Corp (MNKD) leadership • Q3 2024

    Question

    Brandon Folkes of Rodman & Renshaw inquired about Afrezza's growth drivers, including the breadth of prescribers, unaided awareness, physician anticipation for new data, and the future evolution of its commercial footprint.

    Answer

    Executive Michael Castagna explained that the current Afrezza strategy focuses on deepening relationships with existing prescribers following a sales force reduction, rather than broadening the base. He acknowledged a market headwind from endocrinologists shifting to weight-loss drugs. Looking ahead, the plan for 2025 is to deploy MSLs to educate the market on new INHALE-3 data to overcome historical safety perceptions and drive growth.

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    Brandon Folkes's questions to Avadel Pharmaceuticals PLC (AVDL) leadership

    Brandon Folkes's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q4 2024

    Question

    Brandon Folkes of Rodman & Renshaw sought clarification on whether Q1 revenue could decline sequentially from Q4, given the commentary about positive trends impacting revenue starting in Q2. He also asked for an update on the pediatric launch and its anticipated contribution in 2025.

    Answer

    Executive Thomas McHugh did not provide specific quarterly guidance but reiterated confidence in the full-year forecast of $240M-$260M, while acknowledging the significant gross-to-net headwinds in Q1 that affect all industry players. Executive Gregory Divis described the pediatric launch as a focus area with positive patient stories but noted it represents a small portion of the overall market due to long diagnosis timelines. He confirmed Avadel is actively pursuing this segment.

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    Brandon Folkes's questions to Indivior PLC (INDV) leadership

    Brandon Folkes's questions to Indivior PLC (INDV) leadership • Q4 2024

    Question

    Brandon Folkes asked for clarification on whether the 71% new patient start share for SUBLOCADE includes both weekly and monthly doses. He also inquired about the perceived advantage of weekly dosing in practice and the company's outlook for returning to top-line growth in 2026.

    Answer

    CCO Richard Simkin confirmed the 71% new start share is a total LAI look, equalizing weekly and monthly doses. He emphasized that efficacy is the key driver for prescribers over dosing flexibility and highlighted the potential competitive advantage of SUBLOCADE's upcoming rapid induction label for the monthly dose. CEO Mark Crossley expressed conviction in a return to growth in 2026, citing a stabilized market post-transition, a large unmet patient need, and SUBLOCADE's leadership position.

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    Brandon Folkes's questions to CorMedix Inc (CRMD) leadership

    Brandon Folkes's questions to CorMedix Inc (CRMD) leadership • Q3 2024

    Question

    Brandon Folkes of Rodman & Renshaw asked about the consistency of patient types being treated with DefenCath across different providers and whether any variability presents an opportunity for education and expansion. He also inquired about the outlook for gross margin, noting its strength in the first full quarter of sales.

    Answer

    CEO Joseph Todisco responded that there is variability in how customers triage patients, with some focusing on benefits verification and others on high-risk status first. He confirmed this variability presents a significant growth opportunity to expand usage into new patient cohorts. Regarding margins, Todisco explained that while initial margins are high partly due to inventory being previously expensed as R&D, he expects the gross margin to remain healthy through 2025 due to the favorable cost of goods relative to the net selling price.

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