10
RLS Global AB (publ) Year-end report 2018

RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB (publ) Year-end report 2018

Page 2: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 2

RLS Global AB (publ) Year-end report 2018 Intensified work with ChloraSolv

JANUARY−DECEMBER 2018

• Net sales amounted to SEK 2.6 million (2.3), a revenue growth of 12.1 percent.

• Earnings before interest and taxes (EBIT) amounted to SEK -21.9 million (-19.3).

• Earnings per share after dilution at SEK -0.36 (-0.34).

• Cash flow from operating activities amounted to SEK -21.7 million (-15.9).

• Cash flow from financing activities amounted to SEK +2.5 million (63.0).

• Liquid assets at the end of the period at SEK 22.6 million (44.9).

• Equity ratio was 84 percent (88).

OCTOBER−DECEMBER 2018

• Net sales amounted to SEK 1.1 million (0.5), a revenue growth of 123.5 percent.

• Earnings before interest and taxes (EBIT) amounted to SEK -5.9 million (-6.3).

• Earnings per share after dilution at SEK -0.10 (-0.11).

• Cash flow from operating activities amounted to SEK -5.0 million (-3.8).

NOTABLE EVENTS DURING THE FOURTH QUARTER

• During November, the Swedish Medical Products Agency approved the new expanded clinical study for ChloraSolv on hard to heal foot- and legulcers with around 60 patients and the clinical study was initiated at the first site. The study name is ”ChloraSolv01”.

• Eva Jagenheim, is appointed CFO, starting on 25th of March.

• The wound-care patent, Dermasolv, is registered in the USA.

• The Periimplantit patent is registered in Europe and in Japan.

• The legal process deriving from a claim from a former co-worker, Karin Bergqvist, is ongoing.

Page 3: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 3

IMPORTANT EVENTS AFTER THE PERIOD

• First patients treated in ChloraSolv01.

• Launch preparedness for ChloraSolv continues. We aim to participate at the EWMA event in Gothenburg in beginning of June.

• At the turn of the year, the first commercial batches of Perisolv were produced at Biora AB. Also the new product ChloraSolv is now ready to be produced by our subcontractor.

NOTABLE EVENTS DURING THE YEAR

DURING THE FIRST QUARTER

• An audit of our Quality Management System was performed by Lloyds (LRQA) with good results.

• An audit of the Medical Device Directive was performed by LRQA, also with good results.

• Continous discussions regarding the CE-registration of ChloraSolv were held with the Notified Body and the Competent Authority.

DURING THE SECOND QUARTER

• Karin Fischer was appointed Chief Executive Officer for RLS Global AB.

• Previous employees and current employees together acquired a total of 462 800 shares from RLS 2015-2018 warrants program.

• At the Annual General Meeting on 13th June a new warrants program (the RLS 2018-2021 warrants program) was approved, consisting of of 1,000,000 warrants. Subsequently, all employees have fully subscribed to the program.

• Kenth Hanssen resigns as CEO on June 13 and Anders Husmark takes the role of temporary CEO.

• Europerio9, ”The world’s leading congress in periodontology”, is going on in late June in Amsterdam where REGEDENT presented clinical data for Perisolv.

• RLS signed an exclusive distribution agreement with Straumann, one of the world’s leading dental companies, Straumann, regarding CariSolv for specific markets.

• We submitted a clinical study application to the Ethical Committée as well as to the Swedish Medical Products Agency regarding ChloraSolv.

• A former co-worker, Karin Bergkvist, presented a financial claim for a one-time payment of SEK 8 million, together with legal costs, as payment for transfer of inventive right.

DURING THE THIRD QUARTER

• The wound-care patent, Dermasolv, was registered in Japan.

• On July 6, the Swedish Companies Registration Office registers that 1,000,000 warrants were acquired by the employees in the new RLS 2018-2021 warrants program.

• The share capital was increased by SEK 52,291.96 and 462,800 new shares were registrered when employee and former employees acquired shares through the 2015-2018 warrants program.

• Karin Fischer started as CEO on 20th August.

Page 4: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 4

Intensified work with ChloraSolv The fourth quarter had some distinct common denominators with the fiscal year of 2018. We

focused our work on preparing for the upcoming commercialization of ChloraSolv. RLS now

has a detailed plan with activities for bringing ChloraSolv to the European markets in a

structured manner.

During 2018 revenues in our dental business area increased by 12 percent compared to 2017. CariSolv met expectations in terms of sales while PeriSolv performed below expecta-tions. Earnings before interest and taxes (EBIT) for 2018 was SEK -21.9 million which is SEK 2.6 million lower than in 2017. This was mainly due to increased costs associated with our extensive quality management project, moving manufactur-ing to Biora in Malmö, as well as investing in a new clinical study. During January 2019 we received an additional set of follow up questions from Lloyd’s regarding the ongoing CE-registra-tion process, which we have submitted answers to in Febru-ary. The reason for Lloyd’s delay with providing the ques-tions to us is a direct effect of the Brexit turmoil. It has led to Lloyd’s moving its Notified Body to the Netherlands in order to retain its rights to approve products for the European Un-ion. Lead times has unfortunately grown because of this which has affected RLS as well as many other companies in the industry. However, we are working hard to ensure that ChloraSolv will be CE-approved shortly and remain confident in a positive outcome. After the CE-approval is received and we have commenced the European market launch, we will set the strategy also for the American market. Our clinical study on chronic wounds, ChloraSolv01, is in pro-gress and we have initiated our first patient testing. The study will lay the foundation for a broader label and scope of use for ChloraSolv. Straumann, our partner on the European market, has fo-cused its efforts on the UK, Germany and Italy in 2018. Strau-mann will work on opening up new exiting markets during 2019. The market reception of CariSolv is positive and an in-creased number of dentists and dental hygienists now un-derstands the benefits with offering minimal invasive dental care. Straumann plans to participate at the large Interna-tional Dental Show (IDS) in Köln between March 12 and 16, where it will launch its General Practitioner portfolio to the international market. We are very proud to have CariSolv as a significant component in that portfolio. Straumann is also arranging a panel debate themed ”Next Generation Dental

Care” where RLS will participate. The debate will be rec-orded and available on a number of different digital plat-forms. Regarding the Nordic market there is a good window to strengthen the positioning of our products further and in-crease the awareness among Nordic dentists and dental hy-gienists. We signed a new agreement with Unident in Febru-ary which we are very excited about. Unident is a company with good presence, highly competent and well renowned on the Nordic market. We are all looking forward to an exciting 2019. Mölndal, 28th February 2019

Karin Fischer CEO, RLS Global AB

Page 5: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 5

ESSENTIAL RISKS AND UNCERTAINTY FACTORS Through its activities, RLS Global AB is exposed to risks of varying significance and nature in its operation. These risks can, in general, be divided into one of three categories: marketrelated risks, operational risks and financial risks.

Marketrelated risks Customer’s willingness to buy goods and services is affected, among other things, by the general economic situation and the desire to try new methods as well as the ability of the new methods to increase efficiency. It cannot be guaranteed that current product registrations can be retained if the regulations change. Furthermore, it cannot be guaranteed that new regulatory approvals will be obtained for our products.

Operational risks Failures in R&D projects due to lack of effect, inadequate method selection or assumptions, production disruptions, delays in deliveries and launches, as well as misjudgements of demand and growth rate, patent infringement and non-granted patent applications. There are eight employees in the company and if one or more of these leave the company, this could have a negative impact on its operations, results and financial position.

Financial risks The company has a negative cashflow and will need additional capital to be able to execute the existing business plan. The company's financing takes place in the long term and with respect for the shareholders' desire to see a steady growth in value. An investment in RLS Global AB is a risk, but also an opportunity for good returns.

PROPOSED DIVIDEND The Board of Directors proposes to the Annual General Meeting that no dividend be paid for 2018.

FINANCIAL INFORMATION - FOURTH QUARTER 2018 Net sales for the period October - December amounted to SEK 1,132 thousands (506), a revenue growth of 123.5 percent compared with the same period 2017. The total operating income for the period amounted to SEK 1,493 thousands (680). During the period, an R&D grant from Västra Götalandsregionen (VGR) of SEK 162 thousands and a Medtech4Health grant from Vinnova of SEK 200 thousands

were reported as other income. The total R&D grant from VGR amount to SEK 500 thousands over time. During the period, the existing patent Cariesdetection 1 was written down by SEK 0.3 million. Earnings before interest and taxes (EBIT) of SEK -5.9 million (-6.3) is on the same level as for the same period in 2017. The investments during the period of SEK 0.8 million (1.5) were comprised of: Capitalized R&D costs for ChloraSolv of SEK 0.6 million (1.2), patent costs of SEK 0.2 million (0.2) and laboratory equipment costs of SEK 0.0 million (0.1).

FINANCIAL INFORMATION - 2018 Net sales for January - December amounted to SEK 2,620 thousands (2,337), a revenue growth of 12.1 percent compared with 2017. The total operating income for the year was SEK 3,059 thou-sands (2,569). The earnings before interest and taxes (EBIT) of SEK -21.9 million (-19.3) was lower than for the year 2017 which to the largest extent is due to higher expenses for quality work, the transfer of manufacturing to Biora in Malmö as well as preparations for the new clinical study, ChloraSolv01. During the four quarters, the company wrote off the intangible assets by SEK 746 thousands (510). In addition, existing patent Cariesdetection 1 in Japan and the US was written down by SEK 317 thousands. The investments of SEK 3.1 million (4.1) for the year included: Capitalized R&D costs for ChloraSolv of SEK 2.2 million (3.3), patent costs of SEK 0.7 million (0.7) and laboratory equipment costs of SEK 0.1 million (0.1). In June, the company received option premiums payments from warrants program 2018 - 2021 for 1,000,000 options subscribed by employees for a total receipt of SEK 1,114 thousands and a purchase price of SEK 1,337 thousands for the purchase of 462,800 shares from the warrants program 2015 - 2018. In addition, the company repaid SEK 12 thousands for warrants program 2016 - 2019 concerning 40,000 options to former CEO, Kenth Hanssen.

AUDIT REVIEW This report has not been subject to review by the company’s auditor.

Page 6: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 6

ANNUAL GENERAL MEETING The date of the Annual General Meeting is May 29, 2019 at 1 PM. The annual report will be available on the website at the latest on April 30th, 2019.

NEXT REPORT The next financial report is the interim report for January - March 2019 and will be published on May 15, 2019.

ASSURANCE The Board of Directors and the CEO have, to the best of their abilities, ensured that this year-end report provides a true and fair view of the Company's operations, position and results, and describes significant risks and uncertainties that the company faces.

TRADING PLACE AND CERTIFIED ADVISOR RLS Global's shares have been listed on the Nasdaq First North since 17th May, 2017 and trading takes place under

the short name RLS. Certified Adviser is Erik Penser Bank, telephone +46 (0) 8 463 83 00, Email: [email protected]. During the period 2012 - 2017, the company was listed on Aktietorget.

OTHER INFORMATION For further information on RLS Global AB's operations, please refer to the company's website: www.rls.global

CONTACT INFORMATION Karin Fischer, CEO E-mail: [email protected] Telephone: +46 (0)702-48 46 51 Annelie Skafte Persson, CFO E-mail: [email protected] Telephone: +46 (0)707-90 95 58

RLS Global AB (publ) Corporate Identity number 556726-3495 Gothenburg 28th February, 2019 Peter Hentschel Karin Eliasson Christer Hägglund Steve Krognes Chairman Board member Board member Board member

PUBLICATION This information is such information that RLS Global AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the above contact person, at 8:30 CET on 28th February, 2019.

Page 7: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 7

Financial information in summary

INCOME STATEMENT (SEK thousands)

OCT-DEC 2018 OCT–DEC 2017 JAN–DEC 2018 JAN–DEC 2017

Net sales 1,131 506 2,621 2,337

Other operating income 362 174 438 232

Total operating income 1,493 680 3,059 2,569

Operating expenses -6,662 -6,800 -23,782 -21,266

Depreciation and write-downs -765 -163 -1,167 -594 Earnings before interest and taxes (EBIT) -5,934 -6,283 -21,890 -19,291

Net financial income/ expense 0 1 -2 -41

Profit/ loss after financial intems -5,934 -6,282 -21,892 -19,332

Tax for the period 0 0 0 0

Profit/ loss for the period -5,934 -6,282 -21,892 -19,332

STATEMENT OF FINANCIAL POSITION (SEK thousands)

Note 31 DEC 2018 31 DEC 2017 31 DEC 2018 31 DEC 2017

Non-current assets

Intangible assets 12,400 10,767 12,400 10,767

Tangible assets 210 167 210 167

Financial assets 50 50 50 50

Total non-current assets 12,660 10,984 12,660 10,984

Current assets

Inventories 1,080 793 1,080 793

Current receivables 2,583 2,537 2,583 2,537

Cash and bank 22,621 44,901 22,621 44,901

Total current assets 26,284 48,231 26,284 48,231

Total assets 38,944 59,215 38,944 59,215

Stockholder’s equity 2 32,536 51,963 32,536 51,963 Current non-interest bearing liabilities 6,408 7,252 6,408 7,252

Total equity and liabilities 38,944 59,215 38,944 59,215

Page 8: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 8

KEY RATIOS

OCT–DEC 2018 OCT-DEC 2017 JAN–DEC 2018 JAN–DEC 2017

Number of shares at year end, before dilution 59,197,695 58,734,895 59,197,695 58,734,895

Average number of shares*), before dilution 59,197,695 58,734,895 58,920,015 56,143,755

Equity ration, percent 84 93 84 88

Return on equity, percent -17 -11 -50 -39

Return on total assets, percent -14 -10 -44 -35

Equity per share, before dilution, SEK 0.60 0.99 0.75 0.85

Earnings per share*), before dilution, SEK -0.10 -0.11 -0.37 -0.34

Earnings per share*), after dilution, SEK -0.10 -0.11 -0.37 -0.34

P/E-ratio Neg Neg Neg Neg

*) Average number of shares is calculated as a weighted average during the period.

STATEMENT OF CASH FLOWS (SEK thousands)

OCT-DEC 2018 OCT–DEC 2017 JAN–DEC 2018 JAN–DEC 2017

Cash flow from operating activities -5,049 -3,777 -21,683 -15,862

Cash flow from investment activities -788 -1,460 -3,062 -4,106

Cash flow financing activities**) 0 0 2,465 62,962

Cash flow for the period -5,837 -5,237 -22,280 42,994

Liquid assets at the beginning of the period

28,458 50,138 44,901 1,907

Liquid assets at the end of the period 22,621 44,901 22,621 44,901 **) Net payment of SEK 2,465 thousands during the period 2018 relates to: 1,000,000 warrants for program 2018 - 2021 with SEK +1,140 thousands, 462,800 warrants redeemed for program 2015 - 2018 with SEK +1,337 thousands and RLS repurchase of 40,000 warrants for program 2016 - 2019 with - SEK 12 thousands.

Page 9: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Year-end report 2018 9

NOTE 1. ACCOUNTING PRINCIPLES

RLS Global AB applies the Swedish Annual Accounts Act (1995: 1554) and the Swedish Accounting Standards Board's general advice BFNAR 2016: 1 Annual report and consolidated accounts. The same accounting principles and calculation bases have been applied as in the latest annual report.

The cash flow statement has been prepared in accordance with the indirect method.

NOTE 2. STATEMENT OF CHANGES IN EQUITY (SEK thousands)

31 DEC 2018 31 DEC 2017 31 DEC 2018 31 DEC 2017

Equity at the beginning of the period 38,470 58,245 51,963 3,333 Warrants**) 0 0 2,465 0 New share issue 0 0 0 70,082 Issue costs 0 0 0 -2,120 Profit/ Loss for the period -5,934 -6,282 -21,892 -19,332 Equity at the end of the period 32,536 51,963 32,536 51,963

**) Net payment of SEK 2,465 thousands during the period 2018 relates to:

1,000,000 warrants for program 2018 - 2021 with SEK +1,140 thousands, 462,800 warrants redeemed for program 2015 - 2018 with SEK +1,337 thousands and RLS repurchase of 40,000 warrants for program 2016 - 2019 with - SEK 12 thousands.

NOTE 3. PLEDGED ASSETS

Pledged assets amounted to SEK 0 (0) thousands.

Page 10: RLS Global AB (publ) Year-end report 2018 · RLS Global AB | Year-end report 2018 6 . ANNUAL GENERAL MEETING . The date of the Annual General Meeting is May 29, 2019 at 1 PM. The

RLS Global AB | Neongatan 5 | SE!431 53 Mölndal | Sweden | [email protected] | www.rls.global