Financial Data and Key Metrics Changes - The company reported net revenue of $200.5 million for Q2 2025, representing a 16% increase year over year from $172.8 million in the prior year quarter [6][28]. - Non-GAAP adjusted net income for Q2 2025 was $53.8 million, or $0.92 per diluted share, compared to $24.5 million, or $0.43 per diluted share in the prior year quarter [29]. Business Line Data and Key Metrics Changes - The core product, Wakix, achieved net sales of $200.5 million in Q2 2025, with an average of 7,600 patients, reflecting an increase of approximately 400 average patients for the quarter [14][28]. - The company is advancing multiple late-stage development programs across three core areas: sleep-wake, neurobehavioral, and rare epilepsies, with peak sales potential of $1 billion to $2 billion across multiple indications [7][12]. Market Data and Key Metrics Changes - The U.S. market for Fragile X syndrome is estimated to have around 80,000 patients, similar in size to the diagnosed narcolepsy market, but currently lacks FDA-approved treatments [9][21]. - The company anticipates significant growth in the narcolepsy market, projecting Wakix to achieve blockbuster status with over $1 billion in annual revenue [6][17]. Company Strategy and Development Direction - Harmony Biosciences aims to build a robust pipeline with eight innovative assets across 13 development programs, including up to six Phase III trials by the end of the year [12][34]. - The company is focused on expanding its commercial infrastructure and leveraging its unique position as the only non-scheduled treatment option for narcolepsy to drive growth [15][17]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of Wakix and reaffirmed full-year revenue guidance of $820 million to $860 million, with expectations of achieving over $1 billion in annual revenue from narcolepsy alone [17][31]. - The upcoming top-line data readout for ZYN-two in Fragile X syndrome is viewed as a potential transformational moment for both the company and the patient community [34]. Other Important Information - The company has over $670 million in cash and cash equivalents, providing financial flexibility for strategic expansion and investments in its pipeline [13][30]. - A research collaboration with SERC Biosciences aims to develop novel regenerative cellular therapies for advanced neurological disorders, aligning with the company's commitment to patients with serious conditions [11][61]. Q&A Session Summary Question: Timing and expectations for the ReConnect top-line data readout - Management confirmed that the top-line data for the ReConnect study is on track for Q3 and emphasized the high level of confidence in achieving statistically significant outcomes [36][39]. Question: Data disclosure for the Fragile X top-line readout - The top-line data will include demographic data, safety, tolerability, and efficacy on primary and key secondary endpoints, with plans for a pre-NDA meeting if results are positive [44][45]. Question: Impact of Takeda's Orexin on the market - Management remains confident in Wakix's differentiation and its ability to continue growing despite new entrants, citing strong physician familiarity and broad clinical utility [78][79]. Question: Factors affecting revenue guidance - The company noted that trade inventory drawdown and underlying demand are key factors influencing revenue, with expectations for strong growth in the upcoming quarters [81][83].