Boston-based digital therapeutics company Akili Inc. (Nasdaq: AKLI) will lay off 40% of its staff as it shifts away from its legacy prescription digital therapeutic strategy.
The company has long contended that its FDA-cleared digital therapeutic could and should be covered under health plans because of the physicians’ role in doling out access to its services. But on Wednesday, Akili announced it would stop its prescription model and rely on non-prescription user subscriptions. The company will continue to see regulatory clearance for over-the-counter labeling for its products, according to a news release.
The shift in strategy comes with staff reductions. Akili will eliminate its field sales force and market access teams. The company said these teams account for about two-thirds of the workforce reduction.
“A non-prescription model removes reliance on intermediaries, which we believe will give us more control over our growth and enable us to build a lasting, sustainable business,” Eddie Martucci, CEO and co-founder of Akili, said in the release.
Specifically, Akili’s shift to non-prescription digital therapeutics reduces the company’s reliance on payers to cover its products and, thus, enables the company to have greater control over its financial success, Martucci said.
The company projects the changes will help increase the ease of access to video game treatments for inattentive or combined-type ADHD. Its two primary products are EndeavorRx — a prescription digital therapeutic product for children ages 8 to 12 — and EndeavorOTC — a non-FDA-approved version of EndeavorRx aimed at adults.
EndeavorOTC is available to the public via the FDA’s Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
Martucci points to the performance of EndeavorOTC in presenting the company’s pivot.
EndeavorOTC gleaned 126,000 first-time downloads, 4,200 active users and an average of $81.88 per user from June 6 to Sept. 5, 2023, the first three months it was available on the Apple App store.
Further, the app had a 67% two-month retention rate, according to the release. Akili made $341,000 during those three months.
“We believe that our shift to a consumer-led model across our business will maximize our reach in the ADHD patient community and allow us to potentially expand into other large markets, without many of the high-cost centers of a prescription model,” Martucci said.
Akili also plans to present clinical data to the FDA to get over-the-counter clearance for EndeavorOTC later in 2023 and to convert the prescription clearance for EndeavorRx to over-the-counter in 2024.
This is the second time this year that Akili has announced layoffs. The company started 2023 by announcing it would lay off 30% of its workforce to extend its cash runway.
This latest layoff is expected to extend Akili’s cash runway to the second half of 2025.
The year 2023 has seen a lot of enthusiasm for digital therapeutics as a business prospect fade.
Further, leaders in the space concede that payers are unlikely to seriously engage with digital therapeutics and are looking for other direct payment sources, such as companies.