Brighter : Annual report 2021 (EN) (0 downloads)

Annual Report 2021

Content.

The year in summary. 3

Financial overview. 4

CEO comment. 5

About Brighter. 7

Revenue models. 8

Market overview. 9

Products and services. 12

Geographical focus. 16

Current commercial position. 17

Brighter share. 18

Corporate governance. 19

Corporate Management. 22

Description of risks and risk management. 29

Board of Directors’ Report. 33

Financial Statements. 40

Notes to financial statements. 48

Certification. 78

The year in summary.

  • • Brighter signs 5-year distribution agreement for Actiste® and Actiste® Mini in Qatar

  • • Brighter signs a reseller agreement with Medico, the leading provider of cloud-based health-care-management systems in Indonesia

  • • Brighter enters a Proof-of-Concept collaboration with Chronos Care (Chronos Labs AB) to verify Brighter’s Actiste® service and evaluate the potential for future commercial collaboration in Sweden

  • • Brighter enters into a commercial collaboration agreement with VivBon AB in Sweden for the Actiste® portfolio

  • • Brighter initiates partnerships and discussions with important stakeholders in the United Arab Emirates

  • • Brighter signs a collaboration agreement for Actiste® Mini with Padjadjaran University in Indonesia

  • • Brighter is notified that its distributors in Nigeria and Ghana wish to renegotiate the distribution agreements – estimated revenues will either be substantially reduced or not materialize

  • • Actiste® and Actiste® Mini receive several different market approvals around the world

  • • Brighter and Nectarine Health receive patents in Brazil and USA

  • • Brighter receives clarification from the United Arab Emirates Ministry of Health and Prevention regarding data storage and processing for the Actiste® Diabetes Management Solution

  • • Compatibility with new insulins opens up new market opportunities for Brighter’s Actiste®

  • • Brighter’s subsidiary Nectarine Health at Home is registered with the FDA

  • • Brighter’s subsidiary Nectarine Health signs an agreement with CK-Caregivers and continues expanding trials in the US

  • • Brighter’s subsidiary Nectarine Health signs an agreement with Peace of Mind Aging to expand trials in the US

  • • Brighter’s subsidiary Nectarine Health gains proof of concept from its US end-user trial for Medicare reimbursement

  • • Brighter’s subsidiary Nectarine Health enters into an agreement and expands its user trials with Solutionology Health payments to its end-user trial

  • • Brighter’s former subsidiary Camanio (divested in December 2021) launches an innovative pilot project with Tomelilla Municipality and wins allocation decisions for stationary security alarms with several municipalities in Sweden

  • • Actiste® receives positive ratings in user-experi-ence research at two health centers in Sweden

  • • Erik Lissner is appointed interim Chief Executive Officer while Christer Trägårdh, former interim CEO, is elected as Chairman of the Board

  • • Emilie Erhard Winiarski resigns as a Brighter Board member

  • • Karin O’Connor and Clas Lindbergson are elected as new Board members

  • • Christopher Robinson is appointed interim Chief Financial Officer

  • • The previous CEO Henrik Norström and the previous chairman Truls Sjöstedt do not receive discharge of liability for their administration in the fiscal year 2020. All other members of the Board receive discharge of liability

  • • Brighter holds an EGM to change the limits of the share capital in the Articles of Association

  • • Brighter terminates its financing arrangement with Unwrap Finance Nordic AB

  • • Brighter commences legal action against Unwrap Finance Nordic AB

  • • Brighter carried out a unit issue which was subscribed to 121percent a contributed SEK 142 million to the Company

  • • Brighter carries out a private placement of 39.7 MSEK

  • • Brighter sells its wholly owned subsidiary Camanio AB for SEK 65 million

  • • Brighter sells its holdings in Blodtrycksdoktorn AB for SEK 5 million

KSEK

Nettoomsättning

12 286

2 398

0

0

Rörelseresultat

-101 604

-35 029

-226 990

-79 810

-48 605

-24 395

Finansnetto

-10 991

502

-13 575

-9 875

-4 475

-2 897

Resultat före skatt

-112 595

-34 527

-240 565

-89 685

-53 080

-27 292

Balansomslutning

342 880

255 664

342 880

255 664

170 616

111 354

Eget kapital per aktie

1,16

1,49

1,25

1,67

2,19

1,54

Soliditet

75%

81%

75%

81%

63%

78%

TSEK

2021

2020

2019

2018

2017

Net turnover

1 266

1 665

2 398

0

0

Operating profit/loss

-185 480

-207 034

-79 809

-48 605

-24 395

Net financial items

-24 400

-13 473

-9 875

-4 475

-2 897

Profit/loss before tax

-209 880

-220 507

-89 685

-53 080

-27 292

Balance sheet total

268 745

338 917

255 664

170 616

111 354

Shareholders’ equity per share

0,59

1,23

1,67

2,19

1,54

Equity ratio

77%

74%

81%

63%

78%

Jan-dec

Jan-dec

Jan-dec

2019

2018

2017

Okt-dec 2020

Financial overview.

Finansiell översikt.

Okt-dec 2019

Jan-dec 2020

5 977

CEO comment.

Firstly I would like to thank each and every one of our shareholders for your support during 2021, and secondly I hope that you are as excited as I am about the future. What has become even clearer now as I have visited some of our target markets, is that our solutions clearly meet the global trends in digital healthcare. My meetings with key stakeholders in the public and private healthcare sector confirm the need to find new innovative digital solutions to initiate behavior change in both diabetic patients and caregivers. And what is even more promising is the positive interest in our solutions. This strengthens my belief that 2022 is the year when Brighter breaks through the market with Actiste® Diabetes Management as a Service.

2 398

Early in the year, Brighter’s Board of Directors and leadership team agreed to sharpen the compa-ny’s geographical focus for the initial commercialization of Actiste® Diabetes Management as a Service. We decided to put a united effort behind bringing the solution to market in Qatar. A country where – according to the International Diabetes Federation – diabetes prevalence among adults is at least 17 percent, which is almost double the global average. Another strong reason for choosing Qatar was the 5-year distribution agreement signed with Al Danah Medical Company, one of the leading distributors of medical and biomedical equipment, pharmaceuticals, OTC products, disposable medical products and dermo-cosmetic products in Qatar. In Q1 2022 we succeeded in bringing the Actiste® Diabetes Management as a Service to market in the area and we are now committed to build-ing “Centers of Excellence” where doctors, hospitals and care facilities will use and prescribe our solution to patients with the aim to create a more efficient care.

Reaching milestones.

During the year, we achieved several important commercial milestones for Actiste® Diabetes Management as a Service, carrying Brighter forward also in other key markets.

Among those were several different market approvals around the world, new market opportunities opened up for the company as Actiste® was evaluated and proved to be compatible with insulin cartridges from BIOTON S.A and Brighter and Nectarine Health received patents in Brazil and USA.

I have also met with most of our partners in the United Arab Emirates and together with our sales team started discussions with new important stakeholders in the area. We were very happy to receive a positive assessment from the Ministry of Health and Prevention (MOHAP) regarding data storage and process-ing in the Actiste® and we are now, through new connections and efforts hoping to soon receive the necessary outstanding regulatory approvals we need to be able to proceed with the commercialization plans in the area. A step toward, is the Memorandum of Understanding we signed with Emirates Health Services in Q1 2022 with the intention to jointly roll out an Actiste® user experience study.

Agreements and collaborations in Indonesia.

I believe Indonesia is a great market match when it comes to digital healthcare solutions. Indonesia, with its 252 million people, is severely affected by diabetes and theproblem is growing from year to year. But at the same time we see a technological development where older systems do not slow down innovation, and where there is great interest in applying smart digital solutions for healthcare. I am equally excited about the reseller agreement we signed with Medico, the leading provider of cloud-based healthcare-management systems in the country as I am about the collab-oration with Padjadjaran University, hospitals and local authorities. All of this together has led up to the start of a user study in West Java in the first part of 2022.

Positive outcome of user tests.

At the end of the year I was very happy to announce the positive feedback from a user-experience in Sweden with Actiste® Diabetes Management as a Service. In Sweden, we also entered into a commercial collaboration agreement with VivBon and a Proof-of-Concept collaboration with Chronos Care (Chronos Labs AB) to verify Brighter’s Actiste® service.

Progress for Nectarine Health in the US.

Brighter’s Subsidiary Nectarine Health entered into several agree-ments and expanded its user trials

in the US. The end-user trial resulted in a proof of concept for medical reimbursement, and the company has conducted its first commercial transaction with a subscription payment method.

Increased attention to cost management and significant capital boost.

Another of our major focus areas during 2021 was to implement the Board of Directors’ updated strategic direction in terms of increased attention to cost management, and a disciplined culture of governance and control. The Board also decided to streamline our operations to fully focus on Brighter’s core business in data-driven and connected diabetes care. As a result, during 2021 we divested all our holdings in Camanio and Accumbo, and we continued to explore alternative ways to finance Nectarine Health.

All of the above will lead to a more agile company with a stronger position. However, it will also reduce our overall capital requirements and establish a more robust position that allows us to put the required resources behind the continuous commercialization of Actiste® Diabetes Management as a Service in key markets. Our capital base received a significant boost in the beginning of 2021 from a unit issue which was subscribed to 121 percent and contributed MSEK 142 to the company. I’m also very pleased with the outcome of the rights issue that we executed in January 2022. The issue was subscribed to 85.4 percent and brought the company MSEK 100 before issue costs. We also have the TO7 and TO8 warrants that, with continued support, can bring in up to MSEK 126,7 in June 2022 and up to MSEK 75 in June 2023 to further support the company’s establishment on the global market.

Increased focus to invest in digital healthcare.

The challenges of the Covid-19 pandemic continued during 2021, however the acceleration of a more digital healthcare sector has also opened new opportunities for companies like Brighter. At the same time diabetes is a rapidly growing problem around the world, expected

  • to increase from 537 million people

  • to 783 million people from 2020

  • to 2045. Besides the suffering for those living with diabetes, it also causes enormous costs for society – estimated to reach 815 billion USD in 2045. Throughout the year we met healthcare providers and stakeholders in different parts of the world who all echoed the same sen-timent: a willingness to invest more in digital-healthcare and connected solutions that bring data insights.

Brighter entered 2022 with a solid strategy, a clear focus, and the financial resources we need to achieve our goal of commercializing Actiste® Diabetes Management as a Service in Qatar and beyond. With long sales cycles and market approval processes we cannot influence, we are humble and grateful towards our shareholders for the ongoing support as we aim to realize the potential of this solution to transform data-driven healthcare.

I look forward to an exciting 2022 and to drive the company forward with all the excellent employees at Brighter.

Erik Lissner

Interim CEO of Brighter AB

About Brighter.

Brighter operates in the med-tech industry and works to meet a number of serious challenges driven by global changes in society, as described below. These challenges are largely based on demographic and social shifts in the population, combined with limited resources in society and increasing costs in healthcare. This all gives rise to an extensive need for increased efficiency and new innovative solutions that meet needs in both the short and long term. The Company is purpose-driven and must therefore ensure that all its solutions contribute towards increased quality of life for the end user, and to a better society. The main part of our business is focused on creating solutions for connected and data-driven diabetes care, as well as digital care and support in the home. The Company believes that our solutions can create new opportunities and value for a broad group of stakeholders: patients and their relatives, healthcare providers, authorities and governments, insurance companies and employers, the pharmaceutical industry, clinical-research organizations, and academic organizations.

Proactive and data-driven healthcare.

Brighter strives to become a leading player in mobile health and data-driven healthcare. Above all, the Company’s products must contribute to a clearer picture of the individual’s health. By handling data from various medical technology tools and applications, the Company aims to deliver reliable and vital data to the user in a smart and easy-to-handle way – data that the individual can then choose to share. Actiste® Diabetes Management as a Service provides an opportunity to connect the user with care through a cloud-based service. This can boost the individual’s motivation and quality of life, while care services receive the information needed for optimizing treatment and counseling.

Digital care and support at home.

Through acquisitions in 2020, Brighter expanded into the ‘age-tech’ and care sector, with a focus on innovative technology and services for care and support in the home.

Brighter’s subsidiary, Nectarine Health, has developed an AI-based monitoring solution that enables people to stay in their homes and live a full and safe life for longer. The original product, which is currently used in nursing homes around Swe-den, was developed for professional use. It aims to detect fall accidents and alert caregivers in nursing homes so that response times and the quality of care can be improved. The second-generation of the solution, which primarily focuses on the consumer market, was launched in the United States during 2021. During the year the company has started a number of user trials and also gained proof of concept from its US end-user trial for Medicare reimbursement and completed its first commercial transaction by introducing subscription payments to its end-user trial.

IP and licensing.

Since its inception, Brighter has had a significant focus on building a strong IP portfolio in digital and con-nected care. Our patent families are related to 1) A combination of func-tions (measurement and injection) in one and the same device; 2) Actual injected dose of medication into the body; 3) Mobile management of connected medical aids; 4) AI-driven management of connected medical aids; and 5) Microneedle technology. The Company considers our IP portfolio and the commercial licensing opportunities it creates as an active business area of its own with significant potential.

The Company’s positioning.

By introducing new methods, services and products that add value, Brighter strives to be a leading Company in the emergence of mobile health and data-driven healthcare. Brighter’s ambition is to drive development towards more efficient and sustainable healthcare by tackling the sector’s biggest challenges: rising costs and limited resources, and the need to change patient behavior. Based on innova-tion and technology, the Company focuses on improving quality of life for people and optimizing the use of available healthcare resources.

Market overview.

Brighter’s solutions enable a wide range of value-creating opportunities for a number of stakeholders, and challenge traditional approaches and boundaries in order to meet the problems that exist.

Building a strong employer brand.

We strongly believe that employer brands are built from both inside and out. We see our company culture as our most sustainable competitive advantage.

We are building our strong employer brand by focusing on personal lead-ership – the number one principle at Brighter is how you lead yourself. By

this we mean how we together lead ourselves in our common context aligned with our values: Smart, Friendly and Reliable.

Taking responsibility and assuming accountability for our behaviors and actions is what shapes our winning company culture. Culture is not in the four walls behind which we work – it is in us and our behaviors.

Revenue models.

Sales of products and services.

In the near future, the largest share of the Company’s revenues are expected to be generated through sales of the Group’s services and products. The diabetes service Actiste® is sold as a subscription model where the pricing strategy is organic and based on the local willingness to pay. The purpose of this type of pricing strategy is to increase awareness and maximize the number of users.

The Company considers Actiste®, with its Benefit Loop, as a solution where the value of the data and the insights that can be generated by many users have the potential to form their own business area that can compensate for a lower price, which means that the service can be priced competitively in certainmarkets with lower purchasing power. The Nectarine service launched in the US in 2021 will also be sold as a subscription service.

Health and treatment data.

In the long term, Brighter also intends to provide both the key to and be the market platform for user-generated health data. The databases that, with the permission of the users, are generated over time in Brighter’s platforms may be used in long-term community planning, national health initiatives, research projects, clinical studies and in the development of medicines. The ambition is to offer the Company’s data banks and insights to community bodies and the pharmaceutical industry for a fee, in order to further improve the quality of life for people with diabetes.

Being a Brighterian means that:

  • • I make active choices and by that I take personal responsibility and ownership for the consequences of my choices

  • • I lead myself as a role model for my colleagues with an open mind and willingness to grow

Licensing of IP.

Since 2007, the Company has applied for and received a large number of patents and design protection for, among other things, integration of sampling, measure-ment of biomarkers and injection of liquid medication in a single device, and Artificial Intelligence-supported monitoring functionality for medical equipment. An early focus on patents forms the basis for the Company’s broad patent portfolio. The Company has a number of patent portfolios, with both approved and pending pat-ent applications. Approved patents are available worldwide, including in Europe, the United States, India, Indo-nesia, Brazil, Japan, South Korea, China and Mexico. The Company is investigating the possibility of licensing parts of its IP portfolio to external players.

Brighter operates in the med-tech and welfare sectors, and focuses on a number of widespread challenges driven by global changes in society, as described below. The challenges are largely based on demographic and social shifts in the population, combined with limited resources in society and rising healthcare costs. This gives rise to a great need for increased efficiency and innovative solutions that can address the situa-tion in both the short and long term. The Company is purpose-driven and focuses on solutions that contribute to an increased quality of life for the end user. The majority of the business today is focused on solutions for connected and data-driven diabetes care, as well as digital care and support in the home. The Company believes that its solutions in the future can create new opportunities and value for a broad group of stakeholders besides patients, such as relatives, healthcare providers, authorities and governments, insurance companies and employers, the pharmaceutical industry, clinical research organizations, and academic bodies.

A growing aging population.

The world’s population continues to grow, albeit at a slower pace than before. The UN estimates that the growth rate is about 80 million people per year, and that the world’s population will increase by abouttwo billion people during the next 30 years. At the same time, rapidly increasing life expectancy is leading to an extensive demographic shift, with the proportion of older people (65+ years) being the fastest growing age group. In 2050, one in six people in the world is estimated to be over 65 (16 percent), compared with one in eleven in 2019 (9 percent). Regions where the proportion of the popu-lation aged 65 or older is estimated to double between 2019 and 2050 include North Africa, Asia and Latin America and the Caribbean. The UN also estimates that one in four people living in Europe and North America will be 65 or older by 2050. In 2018, the number of people aged 65 or older exceeded the number of children under five globally for the first time in history. The number of people aged 80 or older is estimated to triple, from 143 million in 2019 to 426 million in 2050.1 This demo-graphic shift means that a declining proportion of the population needs to support an increasing proportion of the population that generally has a greater need for support and care.

Increased pressure on care and societal functions.

The financial sustainability of healthcare is becoming an increasing concern around the world, as care is largely financed through public funds in most countries. InOECD countries2, healthcare costs have exceeded economic growth for most of the last 50 years, and these costs are expected to continue to exceed GDP growth over the next 15 years, according to the OECD report “Health at a glance 2019”.3 The trend towards growing healthcare costs is global, and is partly due to the demographic shift whereby an increasing share of the population live longer and need more care. It’s also due to the fact that the prevalence of chronic diseases such as diabetes is increasing sharply in society.4, 5 These parameters increase both the economic and the opera-tional burden on societal functions in health and care. Population aging can also impact the labor market and economic development overall, as well as the fiscal pressures that many countries will face in the coming decades as they continue to build and maintain public health, pension and social-welfare systems.

Digitization and data in healthcare.

One of the biggest challenges facing healthcare organizations and decision-makers worldwide is to improve the quality of and access to care while the population is aging and growing, life expectancy is increasing, and public spending on care is under pressure.6 To meet the challenges without sacrificing on the quality of care, modern technology and digital development will play a

  • 1. United Nations Department of Economic and Social Affairs, The World Population Prospects 2019: Highlights, 2019.https://population.un.org/wpp/Publications/Files/WPP2019_Highlights.pdf

  • 2.https://www.oecd.org/countries/

  • 3. OECD (2019), Health at a Glance 2019: OECD Indicators, OECD Publishing, Paris, 2019.https://doi.org/10.1787/4dd50c09-en

  • 4. Forbes, Aging Populations Will Challenge Healthcare Systems All Over The World, april 2018.https://www.forbes.com/sites/williamhaseltine/2018/04/02/aging-populations-will-challenge-healthcare-systems-all-over-the-world/

  • 5. Dieleman JL, Squires E, Bui AL, et al. Factors Associated With Increases in US Health Care Spending, 1996-2013.

    JAMA. 2017;318(17):1668-1678. doi:10.1001/jama.2017.15927, 2017.https://www.researchgate.net/publication/320915030_Factors_Associated_With_Increases_in_US_Health_Care_Spending_1996-2013

  • 6. Deloitte Centre for Health Solutions, Digital transformation Shaping the future of European healthcare, september 2020.https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-shaping-the-future-of-european-healthcare.pdf

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