Louise Chen • Cantor Fitzgerald

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President and CEO Mike Raab addressed the questions, stating that reaching cash flow breakeven is a clear and important goal that is "not that far off on horizon" based on current guidance. Regarding a potential EU partner, he noted that while the company continues to evaluate opportunities, there was nothing substantive to report at this time.

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CFO and COO Justin Renz explained the XPHOZAH returns reserve was a one-time, $3.8 million non-cash adjustment due to zero product returns since launch, and it will not be carried forward. CCO Eric Foster confirmed that the IBS-C market is expected to improve, noting that despite the traditional Q1 contraction, IBSRELA maintained prescription demand consistent with Q4 and exited the quarter with strong momentum.

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President and CEO, Mike Raab, stated that the payer mix for XPHOZAH is generally 60% Medicare and 40% non-Medicare. He confirmed that portfolio expansion efforts are ongoing but noted it is too early to provide a specific timeline for IBSRELA's peak sales achievement, pending performance data from the newly expanded sales force.

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Chief Commercial Officer Eric Karas reported neffy's overall market share is 1.3%, but it is 6.2% among their target physicians. He noted that the ALK co-promotion expands their reach to 20,000 physicians and expressed confidence in hitting the milestone targets, which he described as reasonable, given upcoming catalysts.

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Richard Lowenthal, CEO, and Eric Karas, CCO, responded that prior authorization requirements vary by payer but represent a significant hurdle, reinforcing their strategy to secure unrestricted access. While specific data on untreated patients is pending a claims analysis, they see a major opportunity to re-engage this group. Regarding an OTC switch, Lowenthal deemed it unlikely in the near term due to significant FDA hurdles related to safety and the difficulty of self-diagnosis for anaphylaxis.

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Joshua Smiley, President and COO, reaffirmed the full-year revenue guidance of $560M-$590M and stated that VYVGART's expected growth rate is in line with consensus. Dr. Rafael Amado, President and Head of Global R&D, confirmed the bemarituzumab data is still expected in Q2 2025 and advised against reading into the specific timing of the release.

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Dr. Harald Reinhart, President and Head of Global Development, detailed that the KarXT bridging study is nearing completion, which will support an NDA filing in early 2025. President and COO Josh Smiley added that the commercial opportunity is significant. Regarding VYVGART, Smiley confirmed they are on track to exceed $70 million in 2024 sales and expect steady, sequential quarterly growth.

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President and CEO Douglas Ingram confirmed the guidance reduction was exclusively from ELEVIDYS and that the company anticipates a significant sales uptick starting in the summer and continuing through the second half of the year. Executive Ian Estepan specified that the PMO franchise guidance remains unchanged at around $900 million, meaning the entire revision applies to ELEVIDYS.

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President and CEO Neil McFarlane stated that the 30% of enrollments already approved for reimbursement will receive product in Q4 as soon as it's available, with more approvals expected. He noted that EU expansion is a top priority, but timing is pending discussions with the EMEA, with an update expected in early 2025. Regarding the PRV, McFarlane highlighted recent market transactions near $150 million and stated they are actively monitoring the market to monetize it. CFO LaDuane Clifton added that the recent financing provides flexibility to time the PRV sale optimally.

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CEO Matt Gline and Priovant CEO Ben Zimmer explained that efficacy approximating the strong Phase II results would be a terrific outcome, providing a wide margin over competitors like HUMIRA. Regarding HS, they noted it's a competitive field and while it remains on the radar, they are also evaluating other, potentially less competitive, indications for brepocitinib.

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Executive Peter Salzmann explained that from a practical standpoint, the therapy is aimed at the difficult-to-treat population. He reasoned that healthcare systems would require patients to first try much less expensive generic and biosimilar therapies, making the refractory setting the most logical and commercially viable position for an advanced therapy like an FcRn inhibitor.

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Executive Peter Salzmann provided a practical perspective, explaining that the availability of inexpensive generic and biosimilar anti-cytokine therapies makes it likely that healthcare systems will require their use first. Consequently, Immunovant's program is pragmatically focused on the difficult-to-treat subpopulation, where there is a clear unmet need and a stronger economic case for a novel therapy.

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CFO Caroline Litchfield stated that formal 2025 guidance will be issued with the Q4 earnings report. She anticipates 'solid growth' driven by KEYTRUDA in earlier-stage cancers, WINREVAIR, CAPVAXIVE, and the upcoming clesrovimab launch. Key headwinds include the expiration of the immunology agreement with Johnson & Johnson and the expected decline in GARDASIL sales in China. Despite these factors, she expects operating margin expansion in 2025.

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CFO David Denton indicated that 2025 guidance, which will detail various financial 'pushes and pulls,' will likely be provided by the end of the current year. EVP and Chief Oncology Officer Chris Boshoff reported that the Seagen integration is progressing very well, with high employee retention and strong revenue of $2.3 billion year-to-date. He highlighted pipeline advancements but did not provide an update to the 2030 sales forecast.

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Jennifer Taubert, Executive VP of Innovative Medicine, stated that TREMFYA is seen as a 'STELARA size or bigger and better' asset, especially with its new ulcerative colitis approval and strong data. John Reed, also an Executive VP of Innovative Medicine, detailed the progress of JNJ-2113, an oral peptide for psoriasis and ulcerative colitis, highlighting its fully enrolled Phase III psoriasis studies and upcoming data readouts.

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