Akili is Getting out of Prescription Digital Therapeutics

Akili is planning a transition from a prescription to a nonprescription business model and focusing on regulatory approval for over-the-counter labeling of its products. In a press release, the company said the consumer model will reduce reliance on payers and enable the company to grow the business for non-drug cognitive treatments.

"Insurers have been extremely slow moving and they are not stepping up for innovative medical products even when they are safe," Eddie Martucci, Ph.D., said.

“We are evolving our business to remove barriers for patients trying to access safe and effective non-drug treatment options,” Eddie Martucci, Ph.D., CEO and co-founder of Akili, said in a press release. “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.”

Moving to a nonprescription model is a big change, Martucci said in an analyst call. “We have been running a prescription model that has dependencies on stakeholders who we don’t solve a direct problem for,” he said. “The friction here was more than we anticipated. Insurers have been extremely slow moving and they are not stepping up for innovative medical products even when they are safe. Additionally, physicians are steadily adopting our products but in today’s world, many patients are unable to navigate and frustrated with the prescription process.”

Martucci said that the company began testing a new approach, releasing its initial nonprescription product (EndeavorOTC) under the Public Health Emergency model that maintains the medical nature of the product but does not require a prescription. On its earnings call a few months ago, Akili announced that it was going to pursue a regulatory path as an over-the-counter, FDA authorized product for EndeavorOTC.

“We now have three months of data on the launch of EndeavorOTC and we believe the data are so compelling and clear that we are going all in on this nonprescription, clinically validated model,” he said on the analyst call.

In June, Akili released EndeavorOTC as a treatment for adults with attention deficit hyperactive disorder (ADHD). The product is mobile video game treatment that has been shown to improve attention and focus, specifically in adults with ADHD. It is built on the same technology as Akili’s EndeavorRx, an FDA-authorized video game treatment now being prescribed for children 8 years to 12 years olds with ADHD.

The clinical trial AKL-T01 showed that the OTC version improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms. In fact, 83% of participants reported clinical improvements in their focus, and 73% of participants reported quality of life improvements, including completing tasks on time, managing multiple tasks at once, and keeping track of important items like wallets or keys.

In its first three months on the market, consumer demand, engagement, and retention surpassed the company’s expectations. “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,” he said.

From June 6. 2023 to Sept. 5, 2023, there were 126,000 downloads of EndeavorOTC on the App Store, more than 15,000 trial subscriptions and 4,170 active subscriptions. This resulted in $341,000 billings, the company said the analyst call. Additionally, these subscriptions resulted in $81.88 in average revenue per paying user, a metric the company uses to determine the economic contribution of each subscriber.

Akili plans to pursue regulatory approval for over-the-counter labeling of its treatment products. It will submit adult clinical trial data later this year to the FDA for OTC authorization of EndeavorOTC and is planning to submit data to the FDA to convert its pediatric prescription product, EndeavorRx, to OTC in 2024.

Because of the restructuring, Akili is reducing its staff by 40%, including field sales force and market access team. The company indicated the move to a nonprescription model will revenue that will support gross margins between 60% and 70% by late 2025.