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CFO Tom McHugh reported an annualized net revenue per patient of approximately $92,000 in Q2, with no material impact from inventory stocking. CEO Gregory Divis added that the price improvement was also due to execution initiatives, not just seasonal gross-to-net changes. Regarding guidance, McHugh indicated the low end implies a similar level of net patient adds as Q2, and both executives suggested the current net price is a reasonable proxy for the second half of the year.

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CEO Gregory Divis noted that the discontinuation rate improved from ~14% in Q4 to a lower rate in Q1, and CFO Thomas McHugh confirmed this improvement was a factor in raising guidance. Divis explained the new lawsuit asserts that Jazz's IH label infringes on five of Avadel's patents. Regarding the low-sodium formulation, he stated that more updates would be provided later in the year.

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Executive Gregory Divis explained that achieving the higher end of the guidance range would be driven by stronger overall patient demand, an increased proportion of switch patients, and improved therapy persistence. He noted that early Q1 trends suggest a stabilization and potential reversal of the declining switch patient trend seen in late 2024. Executive Thomas McHugh reiterated confidence in the full-year guidance while highlighting that Q1 is typically the highest quarter for gross-to-net deductions, which impacts sequential revenue comparisons.

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CEO Gregory Divis stated that while switch patients remained the largest source of new starts in Q3, the new-to-oxybate segment is a rapidly growing portion. Executive Richard Kim added that the majority of switches come from mixed-salt oxybate products. He also noted clear indicators of overall market growth, citing the ~150 prescribers new to oxybate therapy and increased prescribing from lower-volume physicians.

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Chief Commercial Officer Thomas Garner attributed NUPLAZID's strength to an uptick in referrals and prescriptions across all channels, including community and long-term care settings. For Daybue, he noted that the current real-world 18-month persistency of 45% aligns well with prior data. EVP, Head of R&D, Elizabeth Thompson, added that real-world persistency has consistently tracked slightly better than what was observed in clinical trials.

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CFO Mark Schneyer explained that DAYBUE's gross-to-net is expected to stay in the low 20% range, while NUPLAZID's will gradually increase over the next few years as the small manufacturer benefit under the IRA unwinds. He stated that while the company does not provide specific peak sales guidance for DAYBUE, they anticipate meaningful growth from current levels.

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CFO Mark Schneyer clarified that the $1 billion figure represents the current annualized run rate based on Q3's $250 million in sales, not a formal 2025 guidance. He stated that the company is not yet providing 2025 guidance but confirmed that they expect growth in both franchises next year.

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Chief Medical & Scientific Officer Dr. Kumar Budur provided specific placebo response figures from the published CONNECT data and confirmed the RECONNECT study is over 90% powered to detect a one-point placebo-adjusted difference. President & CEO Dr. Jeffrey Dayno acknowledged they have contemplated the synergistic opportunity with orexins, but the current focus remains on advancing their next-generation pitolisant programs and growing the Wakix business.

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Dr. Kumar Budur, CMSO, responded that despite strong orexin data, narcolepsy will likely remain a polypharmacy market due to its multiple symptoms. He noted pitolisant HD is targeting fatigue, a key unmet need. Regarding EPX-100, he confirmed that pursuing a broader DEE indication is an option under evaluation, but the current focus is on the ongoing Dravet and LGS trials.

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Dr. Kumar Budur, Chief Medical and Scientific Officer, defined ZYN002 success as a statistically significant and clinically meaningful result on the social avoidance subscale, noting a 3-point change is meaningful. He confirmed the CONNECT study data would be part of the NDA package. For Pitolisant HD in IH, he stated the INTUNE study provided a good understanding of the necessary duration and endpoints.

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Chief Medical and Scientific Officer Dr. Kumar Budur highlighted EPX-100's established safety profile, noting its prior market history and favorable data from ongoing trials, which do not require special monitoring like some competitors. He stated that while preclinical data supports broader use in DEEs, the current focus is on completing the pivotal Dravet and LGS trials before potentially pursuing a broader or basket-trial approach. CEO Dr. Jeffrey Dayno affirmed this focused-to-broad strategy.

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President & CEO Marcio Souza suggested physicians are habituated to layering drugs but are now learning the new drug's profile. He stated that when background ASMs were reduced, AEs resolved and efficacy improved long-term. He noted strong physician enthusiasm for POWER-three, suggesting the RADIANT data provides significant confidence.

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CEO Marcio Souza stated there was no enrollment slowdown for ulixacaltamide and the pace is being managed intentionally. He said the RADIANT study targets 50 patients with an expected 70/30 focal-to-generalized epilepsy mix. For relutrigine, he expects efficacy in the broader GGE population to be at or above the high bar set in the SCN2A/8A cohort.

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CEO Marcio Souza explained that the RADIANT study, which includes generalized epilepsy patients, is a key step toward a potential pivotal program by providing experience and data in that population. For PRAX-562, he noted that patients are young with high seizure burdens, making any gains highly meaningful. He believes the results will be translatable to a large number of DEEs with similar characteristics, such as high seizure burden and poor tolerability to existing drugs.

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Richard Pops, Chairman & CEO, broadened the focus from just visual AEs to all potential on-target, dose-limiting AEs like insomnia. He emphasized that the six-week data provides a comprehensive view to inform Phase 3 dose selection. Marcus Yountz, VP of Clinical Development, added that complex modeling is underway to determine the optimal dose range based on efficacy, safety, and ease of dosing.

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Rob Iannone, Head of R&D, confirmed the JZP-441 trial has been initiated but gave no guidance on data timing. Phil Johnson, CFO, stated that BD priorities are unchanged, with a focus on rare and orphan diseases. He affirmed Jazz is in a strong financial position to pursue deals, though policy uncertainty might lead to a slightly more conservative capital structure.

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Renée Galá, President and COO, highlighted Xywav's strong performance, with patient adds coming from both new-to-oxybate patients and switches from all high-sodium oxybates. She noted that when full generics launch (anticipated in 2026), they will require their own REMS, and Xywav's value will be driven by its low-sodium differentiation, supported by strong payer coverage and ongoing data generation. Bruce Cozadd, CEO, added that the high-sodium business now represents less than 10% of total revenue.

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President & COO Renée Galá highlighted Xywav's strong performance, with patient adds coming from both new-to-oxybate patients and switches from all high-sodium oxybates. She noted that for 2026, with potential full generic entry, Xywav's differentiation on low sodium and its lack of AB-rating to generics will be key. She emphasized strong payer coverage and continued data generation to support its value.

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EVP, Global Head of R&D Robert Iannone explained that PD-L1 status was not analyzed as it's not believed to affect zanidatamab's efficacy. He described the new pan-tumor study as a way to efficiently extend experience into rare, HER2-treatment-naive tumors and gather more data in HER2-agent-experienced patients, potentially supporting a broad pan-tumor indication.

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EVP, Global Head of R&D, Rob Iannone, responded that they have not analyzed the GEA data by PD-L1 status and do not believe it affects zanidatamab's efficacy. He explained the pan-tumor trial is designed to efficiently generate data across a variety of HER2-expressing tumors, including in patients naive to HER2 therapies and those previously treated with other HER2 agents, to potentially support a broad, tumor-agnostic label.

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CCO Lauren Merendino reported 100% penetration in Priority 1 accounts and 75% in Priority 2, stating the focus has shifted from breadth to depth of prescribing. The strategy involves encouraging use in a wider range of appropriate patients and promoting earlier, second-line use as physician confidence grows. CMO Dr. Elly Barry added that the conservative nature of pediatric oncologists, who weigh long-term effects, necessitates time to build this confidence.

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Chief Commercial Officer Lauren Merendino explained that non-prescribing physicians are either waiting for the right patient or are later adopters who want to see peer experience first. CEO Jeremy Bender detailed that DAY301 is a PTK7-targeted ADC with an exatecan (TOPO1) payload, which he believes has first- and best-in-class potential based on its preclinical profile compared to other PTK7 ADCs in development.

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CEO Jeremy Bender declined to confirm patient-count calculations, reiterating the focus on the steady pace of new patient demand. Regarding DAY301, he confirmed the trial is set to begin in Q4 2024 or early Q1 2025 but stated the company has not yet provided guidance on a data release timeline for 2025.

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Nick Pizzie, CFO, responded that R&D spending is concentrated on late-stage programs with a high probability of success and high ROI. He also highlighted that the commercial infrastructure built for Sunosi and Auvelity provides significant operating leverage for future product launches, which is expected to enhance the ROI of those programs.

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Chief Financial Officer Nick Pizzie stated that the company will take a strategic, ROI-focused approach to the Symbravo launch, leveraging its digital-centric platform to ensure efficient SG&A spend. He reiterated that the launch costs are factored into the existing cash runway, which is expected to last until cash flow positivity, and that the overall strategy is to grow the top line faster than operating expenses.

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CCO Ari Maizel acknowledged a likely Q4 seasonality impact but expressed optimism for continued growth. CEO Herriot Tabuteau stated the Q4 readouts are 'right around the corner' and confirmed the EMERGE trial for AXS-07 is not required for the regulatory decision but will inform commercial strategy.

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CEO Kyle Gano explained the INGREZZA guidance reflects a balance of factors, including competitive and payer pressures and the Q4 sales force disruption, weighed against long-term growth drivers. Chief Commercial Officer Eric Benevich described the initial CRENESSITY patient forms as very diverse, coming from both community endocrinologists and centers of excellence, and including both pediatric and adult patients.

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CMO Eiry Roberts stated the FDA meeting will provide clarity on the Phase III strategy, enabling a program start in H1 2025. She explained that since the Phase II data was generated in patients with inadequate response to current treatments, NBI-845 could potentially be used as either an adjunctive therapy or a stand-alone monotherapy, with both paths being explored.

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