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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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