Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today reported financial results for its third quarter of ...

Financial Data and Key Metrics Changes - The company reported a record revenue of $31.1 million for Q2 2025, representing a 37% increase year over year, and a net income of $3.6 million compared to virtually breakeven a year ago [7][20]. - The cash position at the end of the quarter was $60.5 million with no debt [24]. - Gross margin improved to 65%, up from 60.2% a year ago, driven by lower cost inventory and higher e-commerce sales [22]. Business Line Data and Key Metrics Changes - E-commerce business generated $18.1 million in net sales, a 39% increase year over year [7][21]. - The food grade and pharmaceutical grade Niagen ingredient business grew 135% year over year, with revenue of $7.4 million [8][21]. - TRU NIAGEN revenue increased by 22% to $22.7 million, primarily driven by e-commerce revenues [21]. Market Data and Key Metrics Changes - The company is expanding its presence in wellness clinics, onboarding over 800 clinics nationwide to offer the Niagen Plus product line [8]. - The partnership with Watsons in Hong Kong is contributing to steady revenues, with plans for joint marketing efforts to grow brand presence [22]. Company Strategy and Development Direction - The company is focusing on expanding its Niagen Plus product line and exploring telehealth functionality on its website [9][8]. - A worldwide exclusive license agreement was signed with Haukeland University Hospital for the development of nicotinamide riboside as a potential therapy for Parkinson's disease [17]. - The company aims to maintain its position as the gold standard in NAD science and is committed to scientific innovation in the dietary supplement industry [14][20]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory and strategic goals, highlighting the strong demand for NAD products [19][20]. - The company raised its revenue growth expectation for the full year from 20%-25% to a range of 22%-27% year over year [27]. - Management noted ongoing scrutiny from California regarding outsourcing facility practices but remains optimistic about the partnership with Wells Pharmacy Network [9][10]. Other Important Information - The company has been featured in major media outlets and events, increasing awareness of its products [10][12]. - There is ongoing research into the effects of NAD supplementation on long COVID and fertility, with studies expected to be published soon [15][16][51]. Q&A Session Summary Question: Regarding the initiative for Parkinson's disease - Management indicated that if the NOPARC trial results are positive, they may pivot to nicotinamide riboside triacetate for FDA approval in the U.S. [30][32]. Question: Volume and pricing for NIAGEN IV in clinics - Management noted that while clinics are currently charging high prices for IV experiences, they believe prices need to come down to increase accessibility and volume [36][39]. Question: Steps for treating long COVID - The key milestone to watch is the publication of the Harvard study on NAD supplementation for long COVID, which could lead to a marketing campaign if results are positive [49][54].

Core Viewpoint - Knight Therapeutics Inc. is advancing its neurology portfolio by submitting a marketing authorization application for CREXONT in Mexico, addressing the high unmet medical need in Parkinson's disease treatment [1][3]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring, in-licensing, and commercializing pharmaceutical products for Canada and Latin America [9]. - The company operates through its Latin American subsidiaries, including United Medical, Biotoscana Farma, and Laboratorio LKM [9]. Product Information - CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) designed for the treatment of Parkinson's disease, featuring both immediate-release granules and extended-release beads [2][4]. - The product was developed in collaboration with Amneal Pharmaceuticals, which holds exclusive rights for regulatory approval and commercialization in Canada and Latin America [2]. Clinical Study - CREXONT was evaluated in the RISE-PD clinical study, a 20-week phase 3 trial involving 630 patients, which successfully met its primary and secondary endpoints [5][6]. - The study demonstrated that CREXONT significantly improved daily "Good On" time by 0.53 hours with fewer doses compared to immediate-release CD/LD, with an average dosing frequency of three times per day versus five times per day for IR CD/LD [6]. Market Context - Parkinson's disease is the fastest-growing neurological disorder globally, with approximately 1 million diagnosed patients in the U.S. and an estimated 500,000 affected individuals in Mexico aged 45 to 60 [7][8]. - The average age of diagnosis for Parkinson's disease is 60, and the number of patients is expected to grow significantly as life expectancy increases [8].

Core Insights - Knight Therapeutics Inc. has announced that its New Drug Submission (NDS) for CREXONT has been accepted for review by Health Canada [1] - CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) designed for the treatment of Parkinson's disease, with a market potential exceeding $50 million in Canada and $120 million in Brazil [2][3] - The RISE-PD clinical study demonstrated that CREXONT significantly improves "Good On" time with fewer doses compared to immediate-release CD/LD [7] Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [11] - The company has entered into an agreement with Amneal Pharmaceuticals for exclusive rights to seek regulatory approval and commercialize CREXONT in Canada and Latin America [3] Product Details - CREXONT combines immediate-release granules and extended-release beads, allowing for rapid onset and prolonged drug release [4][5] - The product was studied in a 20-week phase 3 clinical trial involving 630 patients, which met its primary and secondary endpoints [6] Market Context - Parkinson's disease is the fastest-growing neurological disorder globally, with over 100,000 diagnosed patients in Canada and an estimated 6,600 new cases annually [9][10] - The controlled release segment of the Parkinson's treatment market in Canada was valued at $15 million for the twelve-month period ending September 2024 [2]

Core Insights - Roche (RHHBY) is advancing its pipeline candidate prasinezumab into phase III development for early-stage Parkinson's disease based on data from phase IIb PADOVA study and ongoing open-label extensions [1][7] - The candidate is a potential first-in-class anti-alpha-synuclein antibody targeting a known biological driver of Parkinson's disease progression [3] - Year-to-date, Roche's shares have increased by 20.9%, outperforming the industry growth of 4% [1] Development Details - The PADOVA study evaluated prasinezumab's safety and efficacy in 586 randomized patients, although it missed its primary endpoint of time to confirmed motor progression [4][5] - Despite missing statistical significance, positive trends toward reduced motor progression were observed at 104 weeks, with expectations of sustained effects based on additional open-label extension data [5][6] - The ongoing PASADENA and PADOVA open-label studies are assessing the long-term safety and efficacy of prasinezumab in over 750 individuals with early-stage Parkinson's disease [3] Licensing and Financials - Roche holds exclusive rights to prasinezumab under a licensing agreement with Prothena (PRTA) established in December 2013, which includes paying double-digit teen royalties on net sales [7][9] - Prothena has earned $135 million to date, with potential for up to $620 million in additional milestone payments [9] Industry Context - Developing treatments for Parkinson's disease is challenging due to its chronic and progressive nature, with both motor and non-motor symptoms [10] - Other companies, such as UCB and Novartis, are also working on treatments, with UCB's recent investigational drug failing to meet clinical endpoints [11]

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]