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CEO William Lewis agreed that the availability of a new treatment for a previously untreated disease almost always triggers a 'cascade of greater awareness.' He expects this will lead to physicians and patients tracking symptoms more closely, raising the index of suspicion and resulting in more patients being properly identified and documented as having exacerbations, which is key for treatment eligibility.

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CEO William Lewis explained that the indication choices are driven by high unmet medical need and promising early animal data. He noted that the next-generation molecules are being designed with different properties than Brensocatib to optimize for clinical benefit in these new, large indications, with the first candidate potentially entering the clinic next year.

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CEO William Lewis stated the choices were driven by significant unmet medical need and promising early animal data. The goal is to develop next-generation molecules that differ from Brensocatib in ways that could provide clinical benefits in these new, larger indications. He emphasized the aim is to have the biggest influence on the largest number of patients, with the first new molecule potentially entering the clinic next year.

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CEO Will Lewis and CMO Martina Flammer responded. Lewis highlighted that the CRS opportunity could be larger than bronchiectasis, which has a peak revenue potential over $5 billion. Flammer detailed the BIRCH study's design, noting the primary endpoint is the sinus total symptom score. She stated the trial is powered to detect a 0.9-point change, referencing Lyra Therapeutics' REOPEN-2 study as a comparator which showed effects between 0.9 and 1.7 points.

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CEO Will Lewis expressed high satisfaction with the company's strengthened balance sheet. CFO Sara Bonstein detailed the strategic actions, noting the ATM was used opportunistically at a premium price to minimize dilution. She explained the restructured Pharmakon loan adds capital, lowers the interest rate to a fixed 9.6%, and extends maturity to 2029, ensuring the brensocatib launch is fully resourced.

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CEO Will Lewis stated that Insmed's balance sheet is the strongest in its history. CFO Sara Bonstein elaborated that the recent financial maneuvers were deliberate and strategic. She noted the ATM usage was opportunistic at a high premium to the last raise, reflecting sensitivity to dilution. The restructured Pharmakon loan provides additional capital, lowers the interest rate to a fixed single-digit, and extends maturity to 2029, ensuring the brensocatib launch is fully resourced.

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EVP & CCO Jeffrey Stewart noted the alopecia data was transformative and that this next wave of indications could add approximately $2 billion in peak sales for RINVOQ, with potential upside. On aesthetics, he explained the market is stable but the dermal filler segment is challenged by price sensitivity and a consumer shift towards a 'natural look,' which AbbVie is actively addressing.

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CFO Scott Reents confirmed that some aesthetics products are subject to current tariffs but the impact is modest, approximately $30 million, and has been absorbed in the company's guidance. CCO Jeffrey Stewart detailed market share dynamics, noting a Q1 share point gain in U.S. toxins after a Q4 hit, with a goal to recover more share. U.S. filler share is stable, while in China, both Botox and Juvederm have seen positive share momentum following new approvals.

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EVP & CCO Jeffrey Stewart stated that Skyrizi and Rinvoq pricing sees modest, low single-digit declines from rebates, with a one-time impact from the 2025 Part D redesign. CEO Robert Michael reiterated that volume is the primary growth driver. SVP Carrie Strom reported BOTOX's Q4 share was in the low to mid-60s and Juvederm's was in the low to mid-40s, noting encouraging signs of recovery after reinstating the original Alle loyalty program.

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CSO Roopal Thakkar highlighted emraclidine's potential for a differentiated profile, noting its once-daily dosing, lack of food effect, and absence of bladder or hepatic issues seen in Phase Ib data. He stated they do not anticipate a requirement for laboratory monitoring based on current data.

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Dr. Dean Li, President of Merck Research Laboratories, noted that the patient population for the CADENCE indication is underdiagnosed but could be in the range of PAH or larger. Chairman & CEO Robert Davis added that the ex-U.S. launch is in its early stages, with most reimbursements expected in the second half of the year. He confirmed the ex-U.S. market (Europe and Japan) is roughly half of the 90,000 global PAH patients and the launch is on track.

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Dr. Dean Li, President of Merck Research Labs, noted the CADENCE patient population is underdiagnosed but could be in the range of the PAH population or larger. Chairman & CEO Robert Davis added that the ex-US launch is on track, with most reimbursements expected in the second half of the year, and that a pricing adjustment affected Q2 revenue but the outlook remains strong.

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CEO Robert Davis stated that Merck's BD strategy is unchanged despite a complex environment and a disconnect in seller valuation expectations. On reference pricing, he acknowledged the price differential needs addressing and highlighted PBM reform and fair value from foreign governments as key areas for discussion with the administration.

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Dr. Dean Li, President of Merck Research Labs, stated that confidence in WINREVAIR for PAH is very high and that the company is eager to see the Cadence trial results to explore its potential in other forms of pulmonary hypertension. CFO Caroline Litchfield confirmed there were no unusual inventory levels for WINREVAIR, though an adjustment was made for the Medicare Part D redesign.

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Dr. Dean Li, President of Merck Research Labs, reported that no significant safety signals have emerged since WINREVAIR's launch. CEO Robert Davis added that adherence has been strong with fewer discontinuations than expected. He noted that the sickest patients are being treated first, and most are starting on single vials, with an expectation that dosing will align with the STELLAR trial's mix (2/3 single vial, 1/3 double vial) over time.

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EVP John Reed stated that Phase 2b data for the co-antibody in Crohn's and colitis will read out mid-year. He then pivoted to express significant excitement for icotrokinra, an oral IL-23 inhibitor, which achieved a compelling proof of concept in ulcerative colitis. He noted a broad Phase 3 program is being planned for icotrokinra, which aims to offer biologic-level efficacy in a once-daily pill.

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EVP Jessica Moore explained that while a gap may still exist, analyst estimates for these multiple myeloma assets have risen significantly since late 2023, reducing the disconnect. CFO Joseph Wolk and EVP Jennifer Taubert reaffirmed their bullish outlook, with Taubert reiterating conviction in CARVYKTI as a $5 billion-plus asset with expanding capacity.

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Jessica Moore, VP of Investor Relations, clarified that 'patient mix' refers to J&J-specific gross-to-net accounting true-ups as final bills are received from different patient channels. Jennifer Taubert, Executive VP of Innovative Medicine, added that despite this Q3 adjustment, the underlying growth prospects for TREMFYA remain very strong, especially with its recent and upcoming IBD launches.

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An executive, likely CCO Bob Smith, stated the PH-ILD market is 3-4 times larger than PAH, referencing Tyvaso's ~$2 billion run rate in PH-ILD as evidence of the significant opportunity. COO Bryan Giraudo projected the PH-ILD trial's geographic mix will be similar to PROSERA but with a potentially larger contribution from the European Union, where there is a greater unmet medical need due to no approved therapies for the indication.

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President and CEO Nikhil Lalwani stated that a successful NEW DAY study could allow ILUVIEN to be used earlier in the treatment of diabetic macular edema (DME), significantly expanding the addressable market. On prucalopride, he declined to provide product-level revenue but confirmed its strong contribution. He guided that Q2 revenue for the product would be lower than Q1 as the company manages inventory ahead of its 180-day exclusivity period ending in late June.

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Executive Nikhil Lalwani clarified the access issue relates to underfunded patient assistance programs for Medicare patients, which ANI is addressing with its own programs and by working with HCPs. He expressed confidence in long-term growth due to a large addressable market. For Cortrophin, he confirmed a typical Q1 sales dip is expected due to insurance resets, followed by strong sequential growth, noting the raised guidance reflects strong underlying momentum.

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Executive Nikhil Lalwani responded that Cortrophin's growth is almost entirely driven by increased volume, not price. He specified that this growth is broad-based, occurring across all targeted therapeutic areas and from both new and existing prescribers. Lalwani clarified his earlier remark, stating that the rare disease business is expected to be the 'largest driver of growth' for ANI moving forward, rather than necessarily the largest segment by revenue.

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CEO Thomas Lingelbach explained that Q1 was strong but in line with internal expectations, noting that the prior year's Q1 was impacted by supply constraints, resulting in different sales phasing this year. He confirmed DoD supply is ongoing as planned. On gross margins, he reiterated that IXCHIQ is expected to yield better margins over time and expressed satisfaction with the strong Q1 performance without committing to a specific 2025 gross margin target.

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Chief Research Officer Dr. William Rote stated his expectation that the indication would be broad, covering the treatment of FSGS in patients aged 8 and up, consistent with the DUPLEX study's population. He emphasized that the study included various subtypes, like primary and genetic FSGS, and showed consistent effects, supporting a broad label.

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CEO Eric Dube and CCO Peter Heerma expressed confidence in FILSPARI's competitive profile. Heerma highlighted that despite new competition like Fabhalta, Q4 was their strongest quarter. He differentiated FILSPARI by its dual-action mechanism, superior long-term kidney preservation data from the PROTECT study, and flexible dosing. He anticipates new competitors will initially have narrower labels for high-risk patients, positioning FILSPARI as a foundational therapy. Dube added that the company is prepared for any REMS scenario.

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CFO Dave Denton affirmed the dividend remains a critical component of the capital allocation strategy, supported by improving operating margins. Aamir Malik, Chief U.S. Commercial Officer, noted that Paxlovid utilization tracks infection rates and that the company anticipates typical seasonal waves. Alexandre de Germay, Chief International Commercial Officer, highlighted strong international Comirnaty performance and expanding commercial Paxlovid sales.

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Executive Chris Boshoff highlighted promising immunogenicity data for PCV-25 against serotype 3 and confirmed the pediatric study is ongoing. He clarified that the ponsegromab cardiovascular study was stopped, while the cancer cachexia program is advancing to Phase III. CEO Albert Bourla added that PCV-25 development will help accelerate the next-generation PCV-30+ vaccine.

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CFO David Denton confirmed the reduction was largely due to the Oxbryta withdrawal and that the underlying non-COVID business remains strong, maintaining its 9-11% growth guidance. Chief Scientific Officer Mikael Dolsten stated he is encouraged by GBT601, noting its higher potency, and said learnings from Oxbryta are being applied, such as focusing the trial on high-performance clinical sites.

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