Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [27] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, compared to $10.8 million in the prior year [32] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [28][29] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, down from $57.8 million, attributed to a decrease in the number of prescriptions written [27] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [28] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with Exua targeting a significant portion of this market [7][9] - SSRIs and SNRIs represent over 60% of all antidepressants prescribed, indicating a competitive landscape for Exua [9][10] Company Strategy and Development Direction - The company is focusing on the launch of Exua, a novel treatment for MDD, which is expected to transform its business model [4][7] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect platform for the launch of Exua [6][14] - The company aims to maintain market share in the ADHD segment despite the entry of generics by launching an authorized generic of Adzenys [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming launch of Exua and its potential to address unmet needs in the MDD market [4][11] - The company anticipates a positive trajectory for Exua as it ramps up commercial efforts, expecting to exit fiscal 2026 as one of the fastest-growing CNS-focused companies [42] Other Important Information - The company has successfully raised $16.6 million through a public offering to support the Exua launch [34] - Aytu BioPharma has restructured its operations, resulting in a new cost structure that projects a break-even level of approximately $52.6 million annually [30] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Management confirmed that a sales meeting is planned before the full launch in the first calendar quarter of 2026 [45] Question: Will promotional materials be pre-cleared? - Management stated they do not plan to pre-clear promotional materials but will follow the traditional submission process [46] Question: What is the strategy for engaging with payers? - Management indicated a selective approach to payer engagement, focusing on government payers due to favorable coverage for MDD [50][52] Question: What are the expectations for the ADHD and pediatric franchises? - Management expects the ADHD and pediatric portfolios to cover general and administrative expenses, with a focus on maintaining margin positivity [58][60] Question: What is the plan for medical affairs and education for Exua? - Management outlined extensive efforts in medical affairs, including engagement with key opinion leaders and participation in medical conferences [61]

Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [28] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA [34] - The net loss for the year was $13.6 million, an improvement from a net loss of $15.8 million in the prior year [32] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, down from $57.8 million, attributed to a decrease in the number of prescriptions written [28] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] - Gross margin decreased to 69% from 75%, primarily due to increased cost of sales in ADHD inventory [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with more than 340 million prescriptions written annually [9] - SSRIs and SNRIs account for approximately 220 million TRXs, representing over 60% of all antidepressants prescribed [9] Company Strategy and Development Direction - The company is focusing on the upcoming launch of Exua, a novel treatment for MDD, which is expected to transform its business [4][7] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect patient access platform for product acquisitions aligned with its focus [6] - The company aims to minimize coverage barriers and enhance patient access through selective payer contracting [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the Exua launch, highlighting positive feedback from psychiatrists regarding the product's potential [41][43] - The company anticipates that the Exua opportunity will significantly enhance its growth trajectory, positioning it as a leading CNS-focused company [44] Other Important Information - The company has successfully completed a public offering totaling $16.6 million gross, which is seen as validation of the Exua opportunity [35] - Aytu BioPharma has launched an authorized generic of Adzenys to maintain market share amid potential competition from Teva [21] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Management confirmed that a sales meeting is expected before the full launch in the first calendar quarter of 2026 [47] Question: Will promotional materials be pre-cleared? - Management stated they do not plan to pre-clear promotional materials, citing confidence in their compliant promotional platform [48] Question: What is the plan for engaging with payers? - Management indicated a selective approach to payer engagement, focusing on ensuring favorable contracting without undermining margins [52][54] Question: What are the expectations for the ADHD and pediatric franchises? - Management expects the ADHD and pediatric portfolios to cover general and administrative expenses, with a focus on maintaining margin positivity [60][62] Question: What is the medical affairs strategy for Exua? - Management outlined an extensive medical affairs effort, including engagement with key opinion leaders and participation in medical conferences [63]

Financial Data and Key Metrics Changes - The company continues to be profitable even through the transition from legacy products to new growth products [4] - KELBRE has shown a 25% growth in prescriptions year-over-year and a 23% growth in the first half of the current year [16] - GOCOVRI has seen a significant increase in patient retention due to Medicare redesign, with 97% of patients having less than $25 co-pay by June [24] Business Line Data and Key Metrics Changes - KELBRE has grown to 35% of the business, with an 80% satisfaction rate among adult users, significantly higher than Strattera's 53% [13] - ZERZUVEY, the first oral treatment for postpartum depression, is expected to set the standard of care, with 80% of women receiving it as a first-line treatment [7] - Anapco, the new infusion device for Parkinson's, is performing well, with demand matching that of AbbVie's product [30] Market Data and Key Metrics Changes - The back-to-school season has shown a 26% growth in the last four-week rolling average for KELBRE, indicating strong momentum [17] - The company has seen a 36% growth in unit shipments of ZERZUVEY quarter-over-quarter, reflecting a healthy brand performance [36] Company Strategy and Development Direction - The acquisition of Sage allows the company to enter women's health while maintaining its CNS focus, indicating a strategic expansion [5] - The company is prioritizing M&A to fill its portfolio with post-Phase II assets, aiming for launches between 2026 and 2030 [58][59] - The company is taking a pause to reevaluate the Sage pipeline while integrating it with its own discovery programs [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ZERZUVEY to become the standard of care for postpartum depression [8] - The company anticipates a strong second half of the year, driven by back-to-school momentum and continued growth in its product portfolio [19] - Management is confident that the increased demand from Medicare redesign will offset the mandatory rebates on manufacturers [26] Other Important Information - The company is exploring the potential of its pipeline, particularly focusing on SPN-817 for seizures, which has shown promising results [41] - The company is also considering the future of XERZUVEY and its potential new indications in collaboration with Biogen [39] Q&A Session Summary Question: Can you discuss the acquisition rationale for Sage? - The acquisition allows entry into women's health while maintaining CNS focus, addressing a significant unmet need in postpartum depression [5] Question: What are the expectations for the collaboration with Biogen? - The collaboration is expected to be mutually beneficial, with both companies learning from each other across various functions [10] Question: How is KELBRE performing in the adult ADHD market? - KELBRE has achieved 35% of the business in adults, with an 80% satisfaction rate, indicating strong market acceptance [13] Question: What is the outlook for GOCOVRI following Medicare redesign? - The redesign has improved patient retention, with 97% of patients having low co-pays, which is expected to continue [24] Question: How is Anapco performing compared to AbbVie's product? - Anapco's performance is in line with AbbVie's product, with both addressing a significant need in the market for advanced Parkinson's treatment [30] Question: What is the company's approach to M&A? - The company remains focused on acquiring post-Phase II assets to enhance its portfolio and ensure future growth [58][59]

Core Insights - Cingulate Inc. is making significant progress towards the commercial launch of its lead ADHD asset, CTx-1301, with a focus on its Precision Timed Release (PTR) platform designed for once-daily dosing [1][5]. Financial Performance - Cingulate reported $8.9 million in cash and $3.5 million in working capital at the end of 2Q25, which is expected to fund operations into late 2025 [5]. Product Development - The company submitted its New Drug Application (NDA) for CTx-1301 on July 31, 2025, with FDA acceptance anticipated in 4Q25 and a potential PDUFA date in mid-2026 [5]. - Positive results from the Phase 3 pediatric trial and fed/fast study have reinforced CTx-1301's efficacy and flexible dosing capabilities [5]. Commercialization Strategy - Cingulate is actively planning for commercialization in collaboration with Indegene, aiming for a product launch in mid-2026 [5]. - The company is also exploring strategic partnerships to expand its global presence [1].

Group 1: Elite Pharmaceuticals Inc. (ELTP) - ELTP is a manufacturer of generic drugs, focusing on controlled-release products which require higher manufacturing skills and vertical integration, differentiating itself in a price-sensitive market [2] - The company holds strong positions in the mixed Amphetamine Immediate Release (IR) and Extended Release (ER) markets, with significant growth driven by the ADHD market [3][6] - According to IQVIA data, ELTP commands approximately 20% of the $400 million generic Adderall IR market and 16% of the $800 million Adderall ER market [4] - In Q4 fiscal 2025, total revenues reached approximately $31.9 million, a 78.3% increase from $17.9 million in the previous year, with operating income rising to roughly $11.2 million from $3.7 million [5] - ELTP entered the lisdexamfetamine (Vyvanse generic) market in early 2025, capturing an estimated 8-10% market share despite competition [6] - The company experienced a pull-back in stock price post-earnings due to a $7.2 million warrant charge affecting EPS and increased competition in the ADHD generic space [7][8] Group 2: TSS, Inc. (TSSI) - TSSI's core business includes systems integration, facilities management, and IT procurement services, with a focus on AI-enabled computer racks [12][13] - The company reported a sales growth of 262% to $44 million in recent Q2, raising its 2025 adjusted EBITDA growth guidance from at least 50% to at least 75% [13] - Despite strong growth, TSSI's stock has pulled back nearly 30%, attributed to investor expectations for better leverage and elevated depreciation expenses from facility build-out [14] - TSSI began production at a new 213,000-square-foot facility in Georgetown, TX, optimized for high-volume AI rack integration, with management expecting profitability within a two-year payback period [15] - The stock is currently trading at a trailing EV/Sales multiple of 1.84x, which is reasonable for a business with multi-year sales visibility and proven growth [16][18]

Core Insights - Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's progress towards the commercial launch of its lead ADHD asset, CTx-1301 [1] - CTx-1301 is designed to provide once-daily stimulant therapy with rapid onset and sustained efficacy, addressing limitations of existing ADHD treatments [1] - Cingulate is preparing for commercialization in the U.S. and exploring out-licensing opportunities internationally, targeting a $22 billion U.S. ADHD market [1] Company Developments - Cingulate is on track to submit the New Drug Application (NDA) for CTx-1301 in mid-2025, which will include data from nine clinical trials [5] - Pediatric and high-dose studies have demonstrated strong efficacy, safety, and flexible dosing for CTx-1301 [5] - The company is actively preparing for a U.S. launch and is initiating scale-up plans pending FDA approval [5]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $174.2 million, up from $164.3 million in Q4 2023, with net product sales of $166.4 million and royalty, licensing, and other revenues of $7.8 million [24] - For the full year 2024, total revenues were $661.8 million compared to $607.5 million in 2023, with net product sales of $637.7 million and royalty, licensing, and other revenues of $24.1 million [26] - GAAP net earnings for Q4 2024 were $15.3 million or $0.27 per diluted share, compared to $1.2 million or $0.02 per diluted share in Q4 2023 [25] - Non-GAAP adjusted operating earnings for Q4 2024 were $48.3 million, compared to $47.1 million in the same quarter last year [25] - As of December 31, 2024, the company had approximately $454 million in cash, cash equivalents, and marketable securities, up from $271 million a year earlier [28] Business Line Data and Key Metrics Changes - Qelbree's annual prescriptions grew by 25% in 2024, with net sales reaching $74 million, a 60% increase over Q4 2023 [10] - GOCOVRI's net sales increased by 9% for the full year 2024 and by 15% in Q4 2024, reaching $37 million [14] - Combined net sales of Trokendi XR and Oxtellar XR were down 22% for the full year 2024, with a further decline expected in 2025 [16] Market Data and Key Metrics Changes - The ADHD market grew by 9% in 2024, with Qelbree's growth significantly outpacing this at 25% [36] - Qelbree's market share in the adult segment is approximately 30% to 32%, indicating room for growth [61] Company Strategy and Development Direction - The company is focused on driving growth from core products, particularly Qelbree, and launching ONAPGO in Q2 2025 [116] - Corporate development remains a top priority, with an emphasis on acquiring revenue-generating products and late-stage pipeline candidates [22][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth despite the loss of exclusivity on Trokendi XR and Oxtellar XR, with a strong emphasis on Qelbree's performance [8][115] - The company anticipates total revenues for 2025 to range from $600 million to $630 million, factoring in expected declines in legacy product sales [30] Other Important Information - The company received a two-plus year patent term extension for Qelbree, extending its patent expiration to 2025 [14] - The FDA approved ONAPGO, a new product for treating motor fluctuations in advanced Parkinson's disease, with a launch planned for Q2 2025 [15] Q&A Session Summary Question: What is the expected revenue range for Qelbree in 2025? - Management indicated that a range of $2.65 to $2.95 billion for Qelbree is a fair estimate, with continued prescription growth as a key driver [33][35] Question: What are the key levers for sales growth this year? - Key levers include continued prescription growth and market penetration, with a focus on adult patients [36][38] Question: What is the competitive landscape for Qelbree? - Management noted that it is difficult to assess the competitive landscape until more data is available from other non-stimulant products [89][92] Question: What is the pricing strategy for ONAPGO? - The pricing for ONAPGO is competitive within the marketplace, though specific figures were not disclosed [94] Question: What percentage of ADHD patients have comorbidities? - Estimates suggest that 40% to 60% of ADHD patients have comorbidities, which can complicate treatment [100][102] Question: What are the company's priorities for business development? - The company is looking for commercial products and mid to late-stage pipeline assets, with flexibility in therapeutic areas [42][106]