Core Viewpoint - Lipocine Inc. announced that its licensing partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada, marking a significant step towards making this oral testosterone replacement therapy available in the Canadian market [1][2]. Company Overview - Lipocine is a biopharmaceutical company focused on developing effective oral delivery of therapeutics using its proprietary technology platform [5]. - The company has several drug candidates in development, including LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy, among others [6]. Product Information - TLANDO is the first and only oral testosterone replacement therapy approved by the FDA that does not require dose titration, targeting conditions associated with a deficiency of endogenous testosterone in adult males [4][6]. - The product was developed using Lipocine's proprietary Lip'ral drug delivery technology platform [4]. Market Opportunity - Canada has over 700,000 annual prescriptions for testosterone replacement therapy (TRT), with approximately 50% of patients covered by private insurance, indicating a substantial market opportunity for TLANDO [2][8]. - Limited promotional activities for existing TRTs in Canada may allow TLANDO to capture a significant market share [2].

Company Overview - Lipocine Inc. is a biopharmaceutical company focused on effective oral delivery of therapeutics, leveraging its proprietary technology platform [7] - TLANDO is a testosterone replacement therapy approved by the US FDA for adult males with testosterone deficiency, developed using Lipocine's Lip'ral drug delivery technology [4][8] Partnership and Market Opportunity - Lipocine has entered into a license and supply agreement with Aché Laboratórios Farmacêuticos S.A, granting exclusive rights to market TLANDO in Brazil [1][3] - The Brazilian market for prescription testosterone products is substantial, with a compound annual growth rate (CAGR) of 34% from 2019 to 2023, and currently no oral testosterone therapy registered in Brazil [2] Aché's Profile - Aché is a leading Brazilian pharmaceutical company with nearly 60 years of experience, focusing on improving lives through a diverse portfolio that includes prescription medications, generics, and OTC products [5][6] - Aché has over 350 brands and 900 drug presentations across more than 150 therapeutic categories, reaching over 20 countries [6] Financial Terms of the Agreement - Under the agreement, Lipocine received an upfront payment and is eligible for additional payments upon achieving regulatory milestones, as well as royalties on net sales [3] - Aché will handle the regulatory submission and approval process in Brazil, leveraging its established commercial capabilities and regulatory expertise [3]