Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 176

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 176
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activity-impulsivity
and is associated with clinically significant impairments in executive functioning. In addition, ADHD is one of the most commonly diagnosed
neurodevelopmental disorders in school-age children and it often persists into adulthood. It is characterized by symptoms of inattention
and/or hyperactivity-impulsivity, and affects cognitive, academic, behavioral, emotional, and social functioning. An estimated 8.4% of
children and 5% of adults in the United States have a current diagnosis of ADHD, and if left untreated can lead to poor occupational and
psychosocial outcomes. According to a report published by Global Market Insights on December 17, 2024, the global ADHD market was valued
at $15.8 billion in 2023 and is projected to grow at a CAGR of over 5.1%from 2024 to 2032. Furthermore, based on a report by Grand
View Research, Inc., ADHD is the 12thmost 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 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-taking or criminal behavior and other
far-reaching effects 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,