Company profile - Brighter Actiste feature image - 16092019 - JPG

CE marks for Actiste device received

Brighter 5 September 2019 Update
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Brighter

CE marks for Actiste device received

Earnings update

Healthcare equipment
& services

5 September 2019

Price

SEK13.12

Market cap

SEK1124m

US$0.10/SEK

Net debt (SEKm) at 30 June 2019 + subsequent raises

1.6

Shares in issue

85.7m

Free float

80.8%

Code

BRIG

Primary exchange

NASDAQ First North

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

15.1

30.9

53.1

Rel (local)

14.4

25.7

52.6

52-week high/low

SEK14.67

SEK7.86

Business description

Brighter is a Swedish healthtech company focused on the development and commercialisation of self-monitoring and self-treatment health solutions for diabetes. Its lead product, Actiste, combines three critical components of daily diabetes management, a blood glucose meter, a lancet and an injection apparatus into one device with mobile connectivity to Brighter’s cloud-based service called the Benefit Loop.

Next events

CE mark decision on Actiste

Upcoming

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Brighter is a research client of Edison Investment Research Limited

Brighter recently announced that it has received CE marking for the Actiste device. In fact, it has received two CE marks as Actiste is regulated under both the EU Medical Devices Directive and the In Vitro Diagnostics Directive due to the multiple functions of the device. Initially, the company will focus on establishing service in the Gulf Cooperation Council (GCC), especially the United Arab Emirates (UAE), Sweden and South-East Asia (in particular Thailand and Indonesia).

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/17

1.4

(22.8)

(0.40)

0.0

N/A

N/A

12/18

1.1

(48.8)

(0.74)

0.0

N/A

N/A

12/19e

0.5

(77.4)

(0.96)

0.0

N/A

N/A

12/20e

24.5

(91.4)

(1.11)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Successfully navigating a complex CE mark process

The CE marking for the Actiste device was more complicated than a conventional application as Actiste combines the functionality of multiple other devices: a blood glucose meter, a lancet and an insulin injection apparatus. Because of this it is regulated under both the Medical Devices Directive (MDD) and the In-Vitro Diagnostics directive (IVDD). To further complicate the issue, these regulations are relatively new and are in the process of being rolled out across Europe, increasing the burden on reviewers. These CE marks are a major milestone for the company.

Initial target market is the GCC

Based on International Diabetes Federation (IDF) calculations, the prevalence of adults (aged 20–79 years) with type 2 diabetes (T2D) in the countries of the GCC ranged from 9.9% to 17.6% in 2015. Also, there are a disproportionate number of disease-related complications in the region with an estimated 40–70% of worldwide disease-related foot amputations occurring in GCC countries. Beyond the GCC, Brighter plans to focus on South-East Asia (especially Thailand and Indonesia), as well as Sweden.

A different model for Actiste

Actiste is being commercialised via a different model than other diabetes technologies, where the company is offering the product paired with its Benefit Loop service that includes both delivery of consumables as well as cloud-based health data delivery. The basic plan includes data sharing with relatives and caregivers, while the extensive plan includes physician networks.

Valuation: SEK1,174m or SEK13.69 per basic share

Our valuation has increased to SEK1,174m from SEK1,099m, although it is slightly lower on a per share basis (SEK13.69 from SEK13.85). The increase is driven by lower net debt (SEK1.6m vs SEK21.5m) and rolling forward our NPVs.

Top priority markets: GCC and South-East Asia

Following the CE marking, the company plans to initially launch the product in the countries of the Gulf Cooperation Council (GCC). The rapid economic development seen in the GCC region has fuelled growing rates of diabetes and diabetes-related complications. The region has some of the highest rates of the disease in the world, ranging from 9.9% to 17.6% of the population (Exhibit 1) and affecting millions of people. The disease is also typically more poorly controlled in this region than in other countries, and an estimated 40–70% of worldwide disease-related foot amputations occur in GCC countries. This positions Actiste as an attractive solution to increasing compliance and improving patient engagement with healthcare in these countries.

Exhibit 1: Adults with diabetes aged 20–79 in countries of the GCC

Source: IDF Diabetes Atlas, Seventh Edition

Additionally, the company is interested in targeting a selection of countries in South-East Asia (SEA), in particular Thailand and Indonesia. The epidemiology of the disease in this region is similar to the GCC countries in that a population with historically low rates of type 2 diabetes (T2D) is seeing increased rates of the disease as a result of economic development. According to the 2017 IDF Diabetes Atlas, an estimated 9.6% of the SEA population (on an age-adjusted basis) is living with the disease. This is similar to rates seen in Europe for instance. However, complicating this is that historically the disease was rare and under recognised resulting in a general lack of knowledge and almost half (45.8%) of these individuals in the region going undiagnosed. Approximately 55% of those with the disease in this region die before the age of 60.1 According to one study conducted in SEA, 22% and 36% of patients with T1D and T2D, respectively, have never had HbA1c diagnostic tests.2

  Ramachandran, A. (2012).

  Pathan, F., et al. (2018). Hypoglycaemia among Insulin-Treated Patients with Diabetes: Southeast Asia Cohort of IO HAT Study. Journal of the ASEAN Federation of Endocrine Societies, 33(1), 28-36

Valuation

Our valuation has increased to SEK1,174m from SEK1,099m, although it is slightly lower on a per share basis (SEK13.69 from SEK13.85). The increase is due to lower net debt (SEK1.6m vs SEK21.5m) following the Q219 financial results and subsequent share offerings (totalling SEK15.8m). Additionally, we have rolled forward our NPVs, which has increased our valuation.

Exhibit 2: Valuation of Brighter

Program

Market

Probability of success

Launch year

Upper tier launch pricing ($ per month)

Lower tier launch pricing ($ per month)

Peak revenue ($m)

Valuation (SEKm)

Actiste

Nordic region

30%

2019

131.3

71.6

5.5

21.8

Gulf Cooperation Council countries

30%

2019

112.5

61.4

45.7

178.3

South East Asia

30%

2019

93.8

51.1

54.7

226.7

EU

25%

2019

133.9

73.0

243.1

680.0

US

20%

2021

143.1

78.0

193.1

421.0

Unallocated costs

(152.5)

Total

1,175.2

Net debt (at 30 June 2019 including July capital raises) (SEKm)

(1.6)

Total firm value (SEKm)

1,173.6

Total shares (m)

85.7

Value per basic share (SEK)

13.69

Source: Edison Investment Research

Financials

The company reported a loss of SEK23.7m for Q219. The increase over Q119 (SEK15.8m) is part due to a SEK4.4m write-off that the company recorded because some of its consumables in inventory expired on account of the CE mark delay. Other increased costs include higher external costs (SEK19.1m vs SEK16.6m in Q119), presumably due to CE marking costs and preparations for the commercial launch. We have increased our expected loss for 2019 to SEK77.4m from SEK63.5m to account for these adjustments. The company ended the quarter with SEK23.1m in cash and SEK40.5m in debt following a series of financings during the period. Subsequent to the end of the period, the company raised SEK15.8m in additional capital through direct offerings. We estimate that the company will require SEK20m in additional capital in 2019 in finance operations and SEK70 in capital (up from SEK60m previously) for 2020. We expect these requirements to be met through the company’s financing agreement with Winance, worth up to SEK160m (for more details, please refer to our previous note).

Exhibit 3: Financial summary

SEK000s

2017

2018

2019e

2020e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

 

1,377

1,052

462

24,532

Cost of Sales

0

0

(497)

(4,906)

Gross Profit

1,377

1,052

(35)

19,626

Sales, General and Administrative Expenses

(9,153)

(13,014)

(20,451)

(21,269)

EBITDA

 

 

 

(19,744)

(44,163)

(63,814)

(76,992)

Operating Profit (before amort. and except.)

 

 

 

(19,946)

(44,326)

(63,844)

(77,021)

Intangible Amortisation

0

0

0

0

Other

31,416

24,455

31,274

0

Exceptionals

0

0

0

0

Operating Profit

(19,946)

(44,326)

(63,844)

(77,021)

Net Interest

(2,897)

(4,476)

(13,576)

(14,390)

Other

(4,449)

(4,278)

(583)

0

Profit Before Tax (norm)

 

 

 

(22,843)

(48,802)

(77,420)

(91,412)

Profit Before Tax (FRS 3)

 

 

 

(27,292)

(53,080)

(78,002)

(91,412)

Tax

0

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(22,843)

(48,802)

(77,420)

(91,412)

Profit After Tax (FRS 3)

(27,292)

(53,080)

(78,002)

(91,412)

Average Number of Shares Outstanding (m)

68.2

71.7

81.4

82.2

EPS - normalised (ore)

 

 

 

(40.00)

(74.00)

(95.87)

(111.24)

EPS - FRS 3 (SEK)

 

 

 

(0.40)

(0.74)

(0.96)

(1.11)

Dividend per share (ore)

0.00

0.00

0.00

0.00

BALANCE SHEET

Fixed Assets

 

 

 

84,961

112,430

133,029

152,722

Intangible Assets

76,794

102,929

122,527

142,125

Tangible Assets

4,738

8,537

9,537

9,632

Other

3,429

965

965

965

Current Assets

 

 

 

26,393

58,186

64,240

22,169

Stocks

0

7,070

5,171

5,171

Debtors

15,931

34,308

32,727

4,033

Cash

10,017

9,031

20,182

6,805

Other

445

7,777

6,160

6,160

Current Liabilities

 

 

 

(23,965)

(63,698)

(53,496)

(53,496)

Creditors

(15,528)

(11,805)

(13,022)

(13,022)

Short term borrowings

(8,437)

(51,893)

(40,474)

(40,474)

Long Term Liabilities

 

 

 

0

0

(20,000)

(90,000)

Long term borrowings

0

0

(20,000)

(90,000)

Other long term liabilities

0

0

0

0

Net Assets

 

 

 

87,389

106,918

123,773

31,395

CASH FLOW

Operating Cash Flow

 

 

 

(24,582)

(68,249)

(76,040)

(62,717)

Net Interest

0

0

0

0

Tax

(99)

0

0

0

Capex

(34,852)

(29,986)

(20,619)

(20,660)

Acquisitions/disposals

0

0

0

0

Financing

7,913

34,655

72,444

0

Conversion of convertible debt instruments

43,065

43,065

0

0

Dividends

0

0

(261)

0

Other

(195)

(14,406)

6,804

0

Net Cash Flow

(8,750)

(34,921)

(17,672)

(83,377)

Opening net debt/(cash)

 

 

 

(1,733)

(1,580)

42,862

40,292

HP finance leases initiated

0

0

0

0

Exchange rate movements

0

0

0

0

Other

8,597

(9,521)

20,243

0

Closing net debt/(cash)

 

 

 

(1,580)

42,862

40,292

123,669

Source: Brighter reports, Edison Investment Research.

General disclaimer and copyright

This report has been commissioned by Brighter and prepared and issued by Edison, in consideration of a fee payable by Brighter. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

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Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

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NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Brighter and prepared and issued by Edison, in consideration of a fee payable by Brighter. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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