Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 344

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 344
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 the 12 thmost prevalent therapeutic indication for dispensed prescriptions and is predicted to grow at a 6.4% compounded annual growth rate until 2030. Despite CII classification and black box warnings and safety liabilities, Vyvanse, Takeda’s branded ADHD medication, generated approximately $3.01 billion in global sales during fiscal year 2023, which ended on March 31, 2024. In August 2023, Vyvanse lost market exclusivity in the United States, resulting in the introduction of multiple generic alternatives. This loss of exclusivity contributed to a decline in sales, and Takeda has 178 projected a further decrease of approximately 47% in Vyvanse revenue for fiscal year 2024 due to increased generic competition. Furthermore, based on a report from LifeSci Capital, it is estimated that CNS stimulants — amphetamine and methylphenidate containing products, represent approximately 90% of all ADHD drug sales. Across the lifespan, ADHD may impede cognitive functioning as well as mental health and development and can have a significant social impact on patient’s lives, causing disruption at school, work, and in relationships and can also be associated with risk -takingor criminal behavior and other far -reachingeffects on wider society. Over the past eight years, ADHD diagnoses have increased 30% in the United States, a trend indicating the need to focus on the diagnosis and treatment for a growing number of patients. The Centers for Disease Control and Prevention, or the CDC, reported that 6.1 million, or 9.4%, of children and adolescents in the United States have ever been diagnosed with ADHD and 5.4 million, or 8.4%, have a current diagnosis, and 62% take medication, while 47% receive behavioral therapy and 23% receive no treatment at all. According to the CDC’s 2022 National Survey of Children’s Health, approximately 1 in 9 U.S. children (11.4%, or 7.1 million) have been diagnosed with ADHD at some point, and 10.5% (6.5 million) currently have the condition. Among those with current ADHD, 58.1% have moderate or severe symptoms, and 77.9% have at least one other co -occurringdisorder. Roughly half (53.6%) are being treated with medication, while nearly one -thirdare not receiving any ADHD -specifictreatment at all. In terms of