Core Insights - BioVie Inc. is hosting a virtual key opinion leader event to discuss the unmet needs and treatment landscape for Parkinson's disease on May 28, 2025 [1] - The event will provide updates on BioVie's Phase 2 trial (SUNRISE-PD) evaluating bezisterim (NE3107) for Parkinson's disease treatment [2] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Parkinson's disease, Alzheimer's disease, and Long COVID [12] - The company's drug candidate, bezisterim, is designed to inhibit inflammatory activation and insulin resistance, which are key drivers of neurodegenerative diseases [12] Clinical Trials and Research - BioVie is currently enrolling patients for the Phase 2 SUNRISE-PD trial, which aims to evaluate bezisterim's safety and efficacy in patients recently diagnosed with Parkinson's disease [9] - Previous Phase 2 studies indicated significant improvements in motor control and "morning on" symptoms when bezisterim was combined with levodopa, with no drug-related adverse events reported [9] Key Opinion Leaders - The event will feature Dr. Suzanne de la Monte and Dr. Mark Stacy, both of whom have extensive backgrounds in neurology and Parkinson's disease research [4][5] - Dr. de la Monte has published over 300 peer-reviewed articles and is known for her research on brain insulin resistance and neurodegenerative disorders [4] - Dr. Stacy has also published extensively on Parkinson's disease and has held various leadership roles in related research centers [5] Parkinson's Disease Insights - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact patients' quality of life [6] - Chronic inflammation and insulin resistance are emerging as critical factors in the onset and progression of Parkinson's disease, highlighting the potential for anti-inflammatory and insulin-sensitizing therapies [7] Bezisterim Overview - Bezisterim is an orally bioavailable modulator that can cross the blood-brain barrier, targeting inflammation and insulin resistance without immunosuppression [8] - The drug has shown promise in treating not only Parkinson's disease but also Alzheimer's disease and neurological symptoms associated with Long COVID [8][10]

Company Overview - Karolinska Development AB holds a 73% ownership stake in Umecrine Cognition, which is focused on developing a new class of drugs to alleviate cognitive symptoms associated with Parkinson's disease [6][2]. - The company is a Nordic life sciences investment firm that identifies and invests in breakthrough medical innovations, aiming to create and grow companies that advance these innovations into commercial products [7][8]. Research Grant Announcement - Umecrine Cognition has been awarded a research grant of USD 420,000 from The Michael J. Fox Foundation to finance preclinical studies evaluating the treatment effect of golexanolone in Parkinson's disease [1][5]. - The grant will support further studies to confirm golexanolone's effects on sleep dysfunction and cognitive impairments related to Parkinson's disease, as well as its impact on disease progression [2][5]. Parkinson's Disease Context - Parkinson's disease is characterized by progressive neurodegeneration, primarily affecting motor functions, but non-motor symptoms like sleep disorders and cognitive impairments often appear earlier and have been historically overlooked [4]. - Current treatments primarily target motor dysfunction, with no approved therapies available for non-motor symptoms, highlighting a significant medical need in this area [4][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]