Summary from Annual Report 2021: Brain+ (BRAINP) is ahead of its IPO plan

“We are dedicated to helping people with dementia and Alzheimer’s disease – their families and their caregivers – through the use of our unique Digital Therapeutic software solutions that are being developed and validated through rigorous scientific and clinical trials. 2021 brought us closer to this core objective and we are now in a strong position to launch our first dementia product in 2023, 2 years ahead of plan. This will be a highly important commercial first step towards leadership in an emerging US billion-dollar market”, said Kim Baden-Kristensen, CEO of Brain+.

The following is a summary of the Annual Report 2021 that was announced today.

Brain+ successfully completed its IPO on the Nasdaq First North Growth Market in Copenhagen in October 2021.  The announced goals were to 1) bring the first Digital Therapeutic dementia product to the market in 2025 through partnership(s) with one or more leading pharma companies and 2) get results from five clinical trials in 2021/2022.

Key big pharma partnership and expected commercialization 2 years ahead of plan

The first partnership with a big pharma company was announced in December 2021, when Brain+ entered a strategic partnership with RoX Health, the digital venture builder of Roche Germany. The partnership led Brain+ to advance the expected launch of its first commercial dementia product “Cognitive Stimulation Therapy – Therapist Companion” on the Danish and German markets to 2023, two years ahead of plan.

The partnership with Roche Germany is very positive, not only due to the 2-year advance of our launch expectations but also because the German market is the most progressive and largest European market for Brain+’ products. Germany has established a centralized process for reimbursement of Digital Therapeutics, a system that is not even in place in the US, which is otherwise the most advanced market for Digital Therapeutics in the world. Roche, like other large pharma companies, is targeting Germany, with a specific focus on dementia, now in partnership with Brain+.

Scientific progress on track

Since the IPO, Brain+ has also progressed its clinical development programs and delivered positive results on its other Digital Therapeutic technologies. In 2021, the R&D organization was strengthened, and in 2022 to date, positive clinical trial results have been announced to support the performance of two of the company’s three core technologies, namely the “Starry Night” memory test and the “Computerized Cognitive Training” technology.

For the rest of 2022, results are expected from five other ongoing clinical studies of “Starry Night”, and “Cognitive Stimulation Therapy” to further support their advancement.

Financial Highlights

• Successful listing on Nasdaq First North Growth Market Denmark in October 2021, which raised the financing needed to accelerate activities and advance the R&D pipeline. The IPO provided Brain+ with proceeds of DKK 17.59 million. In addition, a Pre-IPO round raised another DKK 9.87 million in debt that was converted into equity upon the IPO along with another debt instrument of DKK 0.57 million.
• Net increase (decrease) in cash and cash equivalents in 2021 was DKK 8.6 million compared to DKK 0.7 million in 2020, and on 31 December 2021, the company’s cash and cash equivalents amounted to DKK 10.0 million (31 December 2020: DKK 1.4 million).
• Gross profit was DKK 4.0 million in 2021 compared to DKK 6.7 million in 2020. Gross profit in 2021 is primarily the result of income from innovation-grant funded projects and expenses associated with the public listing of the company.
• Staff expenses were DKK 9.7 million in 2021 compared to DKK 6.5 million in 2020.
• Profit/loss was DKK -7.1 million in 2021 compared to DKK -1.3 million in 2020.

Addressing a very large and growing market for dementia prevention and treatment

Currently, 50 million people are diagnosed with dementia globally (Alzheimer’s disease being the most common cause of dementia), and this number is expected to triple to more than 152 million people by 2050. In the US, one in three seniors die with, or of, dementia, and in the UK, dementia is the leading cause of death for women. In 2030, the global costs of dementia are expected to exceed $2 trillion with an addressable market for digital dementia treatments of approximately $5 billion. In Germany, which is the first target market for Brain+’ products, there are 1.5 million people living with dementia. Of these, around 1 million have mild to moderate dementia, which is the target for the Cognitive Stimulation Therapy dementia product, expected to be launched in 2023. Given reimbursement levels, the present addressable market for this segment in Germany alone is around €400 million.

Comments from the CEO, Kim Baden-Kristensen:

“I am pleased to say that we have progressed better than planned since our IPO, only 6 months ago.

In our IPO Memorandum, we stated that a first commercial launch was likely in 2025. Now, we expect to launch our “Cognitive Stimulation Therapy – Therapist Companion” next year, in 2023 in both Denmark and Germany. This advancement is due to three important new partnerships announced with 1) Rox Health/Roche Germany in December 2021 and with both 2) Biogen/EIT Health and 3) the Danish-German Care Alliance in March 2022. All three are focused on Germany, which is the most valuable European market for Digital Therapeutics. Equally important, we are advancing our science and clinical programs. As an example, we received positive results in February 2022 from the first part of our Oxford study of “Starry Night”. Looking ahead, we expect to receive results from five additional trials from our academic and clinical partners by end of 2022. This will give us data on all three core technologies, Cognitive Stimulation Therapy, Computerized Cognitive Training, and the “Starry Night” memory test, and prepare us for our own in-house studies and additional partner studies.

With this, I remain confident that we can fulfill our vision and bring effective Digital Therapeutics solutions to the market for people with dementia and Alzheimer’s. This converts into increased comfort that we will be able to also reach our commercial goal, which is a significant and leading market share of a billion US dollar market by the end of the decade”.

The Annual Report can be found here: https://www.brain-plus.com/investor/. Please also see the video commentary of the annual report from the CEO and CFO that will be released shortly on the Company’s investor page and Social Media channels.

Contact Information

CEO and Co-founder, Kim Baden-Kristensen
+ 45 31393318
kim@brain-plus.com