Financial Data and Key Metrics Changes - The company reported net revenue of $68.1 million for Q2 2025, reflecting a 64% year-over-year increase and a 30% sequential growth compared to Q1 2025 [18][22] - Gross profit for the quarter was $61.8 million, showing a 60% increase year-over-year and a 32% increase sequentially [18][22] - The company achieved net income of $9.7 million, or $0.10 per diluted share, marking the first net income since the launch of Lumerize [22] - Cash generated during the quarter was $15 million, with total cash, cash equivalents, and marketable securities amounting to $81.5 million at the end of the quarter [22] Business Line Data and Key Metrics Changes - The number of active patients on Lumerize reached 3,100 as of June 30, 2025, representing a 63% increase compared to the same quarter last year [5] - Lumerize net revenue for the quarter was $68.1 million, a 64% year-over-year increase [5][6] - The company raised its full-year revenue guidance for 2025 to between $265 million and $275 million, up from the previous guidance of $255 million to $265 million [17][18] Market Data and Key Metrics Changes - The company noted a significant unmet medical need in idiopathic hypersomnia (IH), with approximately 42,000 diagnosed patients currently limited to a single FDA-approved therapy [8] - The company received orphan drug designation from the FDA for Lumerize's use in IH, which could potentially expand the market significantly [7][8] Company Strategy and Development Direction - The company is focused on expanding Lumerize's market presence and pursuing additional indications, particularly in idiopathic hypersomnia [6][10] - Investments are being made to enhance commercial execution and patient demand for Lumerize, including expanding the sales force and increasing marketing efforts [15][20] - The company is also pursuing a low or no sodium extended release formulation to complement its existing product offerings [10][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of Lumerize, citing positive trends in patient demand and improvements in key metrics such as persistency and reimbursement rates [6][18] - The company is optimistic about the potential for Lumerize to transform the treatment landscape for IH and improve patient care [9][10] - Management highlighted the importance of their intellectual property portfolio in protecting Lumerize and its innovations [25] Other Important Information - The company is actively pursuing legal actions against Jazz Pharmaceuticals to protect its rights and intellectual property, including an antitrust case scheduled for trial [11][25] - The company is committed to leveraging its commercial platform to maximize the potential of Lumerize and explore future business development opportunities [93] Q&A Session Summary Question: Guidance and quarterly trajectory - Management indicated that the guidance reflects expectations for continued patient growth and improvements in key metrics, with the potential for future adjustments based on performance [29][30] Question: Patient initiation and dropout rates - Management noted that improvements in persistency were observed in Q2, and they expect these trends to continue, driven by tailored patient support [32][33] Question: Annualized net revenue per patient and inventory impact - The annualized net revenue per patient was approximately $92,000, with no significant impact from inventory stocking on revenue [39][40] Question: Impact of orexin on narcolepsy business - Management views oxybates as complementary to orexin therapies, emphasizing the ongoing importance of oxybates in treating narcolepsy [50][51] Question: Market sizing and growth rates - Management noted that the oxybate market is growing, driven by increased awareness and diagnosis rates, with Lumerize attracting new patients [56][58] Question: Promotional strategies for idiopathic hypersomnia - Management highlighted the overlap in prescribers for narcolepsy and IH, indicating a strong promotional strategy leveraging existing relationships [72][75] Question: Current mix of switch and naive patients - Over half of the patients on therapy are switch patients, with management encouraged by the adoption cycle and growth from both switch and new patients [81][84]

Financial Data and Key Metrics Changes - For Q4 2024, the company reported net revenue of $50.4 million and gross profit of $45.6 million, with a GAAP operating loss of $3.3 million [23][26] - The company achieved cash flow positive status for the first time since the launch of LUMRYZ, resulting in an increase in cash of approximately $8 million, ending 2024 with $74 million in cash, cash equivalents, and marketable securities [25][26] - Revenue guidance for 2025 is projected to be in the range of $240 million to $260 million, representing a nearly 50% increase over 2024 [27][29] Business Line Data and Key Metrics Changes - LUMRYZ has added over 2,500 net patients since its launch, which is approximately three times that of the nearest competitor [8][10] - Nearly 75% of the total 3,450 net patients added to either LUMRYZ or the twice-nightly mixed salts product are on LUMRYZ as of December 31 [9][10] - The company is seeing broad adoption across all three patient segments: switch patients, oxybate naive, and those who previously discontinued an oxybate [13][14] Market Data and Key Metrics Changes - The company has a commercial coverage of over 90% for its product, which is comparable to competitors [75] - The company is focusing on expanding its prescriber base, with over 200 physicians who have never prescribed an oxybate now prescribing LUMRYZ [112] Company Strategy and Development Direction - The company aims to secure its leadership in the sleep space and maximize the potential of LUMRYZ, which has a market opportunity of $1 billion [10][12] - The refined commercial strategy includes investments to accelerate the launch and enhance patient experience, with a focus on expanding the oxybate market [14][15] - The company is also working on a once-nightly no or low sodium formulation to expand its competitive position in the market [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in LUMRYZ's prospects for 2025 and beyond, citing positive early trends in patient demand metrics [11][32] - The company is optimistic about achieving sustainable operating breakeven and generating positive cash flow in 2025 [27][29] - Management noted that early trends in Q1 are tracking in line with internal expectations, indicating significant year-over-year revenue growth [29][30] Other Important Information - The company is progressing in its Phase III REVITALYZ trial evaluating LUMRYZ in idiopathic hypersomnia, with topline data expected in early 2026 [18][19] - The company is actively involved in ongoing litigation to protect its intellectual property and market position [20] Q&A Session Summary Question: Evolution of sales reps and DTC efforts - The company increased its sales team by 15% to 53 members and doubled the size of its field support and nurse support teams [36][37] Question: Differences between field support and nurse support - Field support focuses on patient pull-through and engagement with physician offices post-prescription, while nurse support directly engages with patients [40][41] Question: Q1 patient trends and gross-to-net inventory - Management noted favorable trends in patient metrics and consistent inventory levels in the channel [52][56] Question: Guidance range drivers - Key drivers include net patients on therapy and demand mix, with early signs of stabilizing trends in switch patients [62][65] Question: Coverage and switching patients - The company has over 90% commercial coverage and has seen minimal hurdles in switching patients to LUMRYZ [75][78] Question: Long-term implications of orexins - Management believes there will still be a role for oxybates, including LUMRYZ, as a nighttime agent despite the excitement around orexin therapies [96][97] Question: Geographic regions and cardiovascular comorbidities - The company has not identified specific geographic areas with lower cardiovascular comorbidities but emphasizes the importance of once-nightly dosing [105][107] Question: Converting one-off prescribers to regular prescribers - The company has seen over 200 new prescribers and is expanding its reach to similar physicians [112][113] Question: Pediatric indication launch - The company is focusing on pediatric prescribers and has seen positive feedback from families benefiting from LUMRYZ [131][132]