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    Roanna Clarissa Ruiz

    Research Analyst at Leerink Partners

    Roanna Clarissa Ruiz is the Senior Managing Director and Senior Biotechnology Analyst at Leerink Partners, specializing in Biopharma with a focus on cardiovascular, endocrine disorders, and infectious disease sectors. She covers companies such as ARS Pharmaceuticals and Xeris Biopharma Holdings, with a recent track record showing a 33.33% success rate and an average return of -16.52% on published stock recommendations. Ruiz began her Wall Street career after earning advanced degrees from Harvard and Cornell, previously holding equity research roles at UBS and H.C. Wainwright before joining Leerink Partners in 2018 and advancing to her current senior position in 2023. She holds a Ph.D. in Biomedical Engineering, a B.S. from Harvard, and brings additional experience from industry consulting at IQVIA.

    Roanna Clarissa Ruiz's questions to scPharmaceuticals (SCPH) leadership

    Roanna Clarissa Ruiz's questions to scPharmaceuticals (SCPH) leadership • Q1 2025

    Question

    Roanna Clarissa Ruiz inquired about the early physician traction for the FUROSCIX launch in Chronic Kidney Disease (CKD) and the characteristics of new patients. She also asked if the recent increase in sales to Integrated Delivery Networks (IDNs) is a sustainable trend for 2025.

    Answer

    SVP of Commercial, Steve Parsons, confirmed the CKD launch is meeting early expectations with strong, immediate uptake from nephrologists. Executive John Tucker added that while they see accelerating scripts from nephrology, the specific indication isn't visible on the script. Regarding IDNs, Tucker stated they are a key strategy and expect Q2 sales to be significantly larger than Q1, noting that both the IDN and non-IDN business channels are growing.

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    Roanna Clarissa Ruiz's questions to scPharmaceuticals (SCPH) leadership • Q4 2024

    Question

    Roanna Clarissa Ruiz questioned if the company could leverage the new CKD indication to secure more favorable payer coverage and asked about the educational efforts required for physicians and patients regarding the Medicare redesign. She also asked about the average prescription size for early CKD patients.

    Answer

    Executive John Tucker detailed the company's educational outreach to physicians about the Medicare smoothing option, noting the patient services hub is a key resource. SVP of Commercial Steve Parsons stated the company is satisfied with its current payer position, having strategically avoided the high-rebate contracts that are now disadvantageous for competitors under the new Medicare rules. Parsons also confirmed that early prescriptions from nephrologists are averaging five to six doses, consistent with expectations.

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    Roanna Clarissa Ruiz's questions to Aquestive Therapeutics (AQST) leadership

    Roanna Clarissa Ruiz's questions to Aquestive Therapeutics (AQST) leadership • Q1 2025

    Question

    Roanna Clarissa Ruiz inquired about Aquestive's commercial readiness for Anaphylm, including CMC, manufacturing scale-up, and sales force hiring plans, and sought details on payer engagement strategies and timelines for achieving favorable market access.

    Answer

    CEO Daniel Barber confirmed that in-house manufacturing capabilities ensure readiness for launch. Sherry Korczynski, an executive leading commercial efforts, detailed plans to hire around 50 sales representatives targeting 4,000-5,000 top prescribers. Korczynski also explained that leveraging existing payer contracts from Libervant will expedite access, with a goal of achieving upwards of 80% coverage within the first six months of launch, aligning with the back-to-school season.

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    Roanna Clarissa Ruiz's questions to Aquestive Therapeutics (AQST) leadership • Q3 2024

    Question

    Roanna Clarissa Ruiz of Leerink Partners asked about the key topics highlighted in the Anaphylm clinical briefing book for the FDA, the progress of PBM negotiations for Libervant, and the expected timing for new Medicaid coverage to impact prescribing trends.

    Answer

    CEO Daniel Barber explained the goal of the FDA meeting is to confirm the completeness of the Anaphylm data package. SVP, Chief Commercial Officer Sherry Korczynski added that PBM and Medicaid negotiations for Libervant have been very positive, with coverage being secured for patients aged 2-5 due to a significant unmet need. Barber clarified that while the financial impact from this age group will be limited, the focus is on gaining market access experience and growing scripts.

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    Roanna Clarissa Ruiz's questions to Akebia Therapeutics (AKBA) leadership

    Roanna Clarissa Ruiz's questions to Akebia Therapeutics (AKBA) leadership • Q1 2025

    Question

    Roanna Clarissa Ruiz inquired about the expected timelines for large dialysis organizations (LDOs) to add Vafseo to their protocols and the potential impact on prescribing rates. She also asked for an outlook on how the average prescription volume per provider might ramp in the second quarter.

    Answer

    CEO John Butler and Chief Commercial Officer Nicholas Grund explained that one of the largest LDOs is planning a significant operational pilot in Q3 2025, with a broader rollout anticipated in Q4. They noted this would more than double the number of patients with access to Vafseo. Regarding prescription depth, they stated that while refills are growing, many prescribers are still in an early trial phase, indicating substantial room for growth as they gain more experience with the drug.

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    Roanna Clarissa Ruiz's questions to Lantheus Holdings (LNTH) leadership

    Roanna Clarissa Ruiz's questions to Lantheus Holdings (LNTH) leadership • Q1 2025

    Question

    Roanna Clarissa Ruiz asked for the key drivers that would place results at the high or low end of the updated 2025 guidance and questioned where resources from the spec business divestiture would be reallocated.

    Answer

    CFO Robert Marshall clarified that the tightened guidance is primarily driven by PYLARIFY's performance post-pass-through expiration, with the new range reflecting the bottom half of the prior range. President Paul Blanchfield and CEO Brian Markison explained the divestiture enhances organizational focus on core growth areas like PET radiodiagnostics and radiotherapeutics, rather than freeing up significant capital, as it's a strategic realignment of personnel and priorities.

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    Roanna Clarissa Ruiz's questions to Lantheus Holdings (LNTH) leadership • Q4 2024

    Question

    Roanna Clarissa Ruiz inquired about the status of the MIRROR study, its potential implications for PYLARIFY's market, and whether its timeline is on track.

    Answer

    President Paul Blanchfield confirmed the MIRROR study, which assesses PYLARIFY in intermediate favorable risk patients, continues to enroll. He stated the last patient is expected in Q4 2025, with the goal of updating NCCN and SNMMI guidelines in subsequent years to expand the total addressable market for prostate cancer staging.

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    Roanna Clarissa Ruiz's questions to Lantheus Holdings (LNTH) leadership • Q3 2024

    Question

    Roanna Clarissa Ruiz inquired about the key factors driving PYLARIFY's third-quarter revenue performance, specifically asking about the impact of seasonality and new strategic partnerships, and how these dynamics are expected to influence results for the remainder of the year.

    Answer

    President Paul Blanchfield explained that while PYLARIFY grew 20% year-over-year, the sequential decline was driven by expected Q3 seasonality, net price compression from newly secured strategic partnerships, and intentional trade-offs on product availability. He affirmed that the company expects sequential revenue growth in Q4 and that PYLARIFY remains on track to achieve blockbuster status in 2024 and be sustained as a $1 billion franchise.

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    Roanna Clarissa Ruiz's questions to CYTOKINETICS (CYTK) leadership

    Roanna Clarissa Ruiz's questions to CYTOKINETICS (CYTK) leadership • Q1 2025

    Question

    Roanna Ruiz of Leerink Partners asked about the rationale for changing the ACACIA-HCM trial to a dual primary endpoint and for details on the statistical plan.

    Answer

    Robert I. Blum, President and CEO, noted the change provides two opportunities for a successful outcome. Fady Malik, EVP of R&D, explained the shift to a dual primary endpoint (KCCQ and peak VO2) was to harmonize the trial design with feedback from global regulators. He added that due to accelerated enrollment, the trial was upsized to ensure over 90% power for each endpoint, with the trial considered positive if either one is met.

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    Roanna Clarissa Ruiz's questions to CYTOKINETICS (CYTK) leadership • Q4 2024

    Question

    Roanna Clarissa Ruiz of Leerink Partners asked for more detail on future business and corporate development goals, including the stage, mechanism, and indications of assets the company might consider acquiring, and how this would be balanced with the current cash runway.

    Answer

    EVP & CBO Isaac Ciechanover explained the focus is on leveraging their muscle biology expertise, looking at preclinical and early-stage clinical programs, primarily small molecules but also exploring other modalities. EVP & CFO Sung Lee affirmed a multi-year cash runway, supported by a $1.2 billion starting balance and access to further capital, with an expected cash utilization in the low $500 million range for the year. President & CEO Robert I. Blum clarified that these BD activities are intended to be modest, complementary investments, not a shift away from the primary focus on aficamten.

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    Roanna Clarissa Ruiz's questions to CorMedix (CRMD) leadership

    Roanna Clarissa Ruiz's questions to CorMedix (CRMD) leadership • Q1 2025

    Question

    Roanna Clarissa Ruiz inquired about the primary drivers of the strong Q1 revenue, the contribution from U.S. Renal Care versus smaller centers, and the metrics supporting the confidence to guide to the upper end of the first-half range. She also asked a follow-up about the outstanding LDO.

    Answer

    CEO Joseph Todisco identified U.S. Renal Care as the main driver, accounting for over 80% of Q1 shipments, but also noted growth from smaller centers and inpatient hospitals. He explained that confidence in the guidance stems from improved inventory tracking and visibility into weekly dispensing at key customers, allowing for better forecasting. He reiterated that he could not speak for the LDO but that their current activities are encouraging.

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    Roanna Clarissa Ruiz's questions to CorMedix (CRMD) leadership • Q4 2024

    Question

    Roanna Clarissa Ruiz inquired about the initial strategy for the new inpatient sales team with Syneos Health, the potential ramp in that setting, and the expected degree of net price erosion for DefenCath starting in Q2 2025.

    Answer

    Executive Joseph Todisco stated that inpatient sales were trending towards 3% of unit volume in Q1 and the new team would be active in 4-5 weeks. Executive Erin Mistry added the team will focus on large academic medical centers. Regarding pricing, Todisco explained that while government ASP is stable, discounts and a potential Q2 shelf stock adjustment will cause some erosion, which is factored into the H1 2025 revenue guidance of $50M-$60M for the base business.

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    Roanna Clarissa Ruiz's questions to UNITED THERAPEUTICS (UTHR) leadership

    Roanna Clarissa Ruiz's questions to UNITED THERAPEUTICS (UTHR) leadership • Q1 2025

    Question

    Roanna Ruiz of Leerink Partners LLC asked for a breakdown of Tyvaso DPI's Q1 revenue growth, specifically the split between patient demand and price increases, and inquired about any notable gross-to-net impacts.

    Answer

    President and COO Michael Benkowitz explained that new patient starts have stabilized at a roughly two-thirds DPI and one-third nebulizer mix. He confirmed a price increase was taken at the start of the year, consistent with prior years. On gross-to-net, he noted that besides a minor additional obligation from the IRA Part D redesign, there were no new significant impacts in Q1, as the major effects were realized in 2024.

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    Roanna Clarissa Ruiz's questions to UNITED THERAPEUTICS (UTHR) leadership • Q4 2024

    Question

    Roanna Ruiz asked if Tyvaso's growth in PH-ILD, combined with increased commercial volumes from the Part D redesign, could potentially offset typical Q1 seasonality.

    Answer

    Michael Benkowitz, President and Chief Operating Officer, noted that while the expanded sales force is driving significant growth in the ILD prescriber community, the financial impact of the Part D redesign largely played out in 2024. He expects the current payor mix of ~90% commercial to be the new baseline and does not anticipate a significant further impact in Q1 or Q2.

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    Roanna Clarissa Ruiz's questions to UNITED THERAPEUTICS (UTHR) leadership • Q3 2024

    Question

    Roanna Clarissa Ruiz inquired about the drivers behind the strong growth in nebulized Tyvaso, whether it included new patient starts, and if more patients are transitioning from the nebulizer to the DPI version.

    Answer

    Executive Michael Benkowitz explained that some of the year-over-year growth in nebulized Tyvaso was due to destocking effects from the previous year. He stated that the product mix has reached a steady state of roughly two-thirds DPI and one-third nebulizer, with minimal transitions between the two delivery systems as the initial wave of switches has largely concluded.

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    Roanna Clarissa Ruiz's questions to ARDELYX (ARDX) leadership

    Roanna Clarissa Ruiz's questions to ARDELYX (ARDX) leadership • Q4 2024

    Question

    Roanna Clarissa Ruiz of Leerink Partners asked about the key drivers for achieving the XPHOZAH peak sales target and the potential for future sales force expansions for either product.

    Answer

    CCO Eric Foster highlighted the ArdelyxAssist program, an expanded field-facing access team, and consistent marketing as key drivers for XPHOZAH. Both Foster and CEO Michael Raab indicated that after the recent IBSRELA sales force expansion, the current focus is on maximizing pull-through with new access managers rather than further expansion.

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    Roanna Clarissa Ruiz's questions to ARDELYX (ARDX) leadership • Q3 2024

    Question

    Roanna Clarissa Ruiz asked for more details on the education and outreach plans for XPHOZAH prescribers ahead of the January 1 reimbursement change and inquired about engagement with non-Medicare payers.

    Answer

    President and CEO, Mike Raab, and Chief Commercial Officer, Eric Foster, emphasized a simple message for prescribers: 'don't change what you're doing.' Foster noted that physicians don't differentiate between payer types and the focus remains on clinical benefits. Raab added that communications with all payers are 'status quo,' with access managed through the ArdelyxAssist program.

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    Roanna Clarissa Ruiz's questions to ARS Pharmaceuticals (SPRY) leadership

    Roanna Clarissa Ruiz's questions to ARS Pharmaceuticals (SPRY) leadership • Q3 2024

    Question

    Roanna Clarissa Ruiz of Leerink Partners asked about the profile of neffy's early adopters, specifically whether they are new patients or switching from auto-injectors, and if early revenues included any bulk orders from non-retail channels like first responders.

    Answer

    Executive Eric Karas responded that early user profiles align with projections, with a majority being previously non-compliant auto-injector users, particularly parents of children with food allergies. He also confirmed that new patients are being prescribed neffy. Regarding bulk orders, he noted significant interest from suppliers for airline emergency kits and other public entities, with active discussions underway and potential revenue impact expected in Q1.

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