Company Release 20.3.2020 at 9:00
BBS- Bioactive Bone Substitutes Plc's Financial Statements Review 1.1.-31.12.2019 (unaudited)
Year 2019 in brief (Reference period 2018)
- Associate Professor Ilkka Kangasniemi was appointed as the new CEO in October 15, 2019. Previous Managing Director, Emeritus professor Pekka Jalovaara continues as an advisor for the company.
- Quality system ISO 13485 was updated in line with the latest requirements.
- Documentation for regulatory handling of CE marking has been updated to reflect new medical device regulation.
- The patent for the manufacture of the protein extract and the final product itself was approved in Canada. An equivalent patent has been in force in Europe and Eurasia for three years.
- Process, end product and quality assurance validations continued. Some yet incomplete validations have no effect on the timetable for the CE marking application process.
- In 2018, an application was submitted to the Notified Body (BSI-UK) in England for the CE marking of ARTEBONE®. Due to the Brexit the cooperation with them ended.
- In the spring of 2019 the submission was suspended due to observed deficiencies in the content of a previously conducted animal experiment. In addition to the GLP formalities, the lack of equivalence between the dose levels of the samples (higher and lower dose in the animal test differed from the dose in the clinical trial) compared to the clinical trial samples, and the lack of adequacy of the control groups with the established regulatory requirements. The authority decision caused the company to carry out an additional animal study to support the application. Samples from the animal test were delivered for histological analysis at the end of the year and first time point results are expected in spring 2020. The rest of results will be available by the end of June 2020.
- The company has begun preparations for the application process with a Dutch Notified Body (BSI-NL).
- BBS had no sales revenue.
- Cash flow from operating activities was EUR -1.444 (-1.701) million.
- BBS's cash and cash equivalents at December 31, 2019 were EUR 0.515 (1.864) million.
- The company carried out a share issue in the Nasdaq First North GM marketplace in Sweden. The issue raised EUR 0.3 million in new assets to strengthen the company's equity ratio and shareholder base in Sweden. The cost of listing during the period was approximately EUR 50 thousand.
Key figures Group
| € 1,000 | 1-12 / 2019 | 1-12 / 2018 |
| Other operating income | 53 | *2262 |
| Personnel expenses | 665 | 669 |
| Depreciation, amortization and impairment | 22 5 | 229 |
| Other operating expenses | 593 | 757 |
| Profit for the period | -1638 | 379 |
| The cash flow of a business | -1 444 | -1 701 |
| Equity ratio% | 31.3 | 39.6 |
| Earnings per share € | - 0.318 | 0,076 |
| Earnings per share, diluted | - 0.308 | 0.073 |
| Number of shares at end of period (BBS) | 5 204 820 | 5 090 520 |
| Average number of shares during the period | 5 146 887 | 4 998 094 |
* Includes a loan agreement of EUR 2.224 million
| € 1,000 | 12/31/2019 | 12/31/2018 |
| Cash and cash equivalents | 515 | 1684 |
| Own capital | 3079 | 4416 |
| Balance sheet total | 9833 | 11,156 |
Equity ratio = Equity / Total assets
Earnings per share = earnings for the period / average number of shares during the period.
Board of Directors outlook for 2020
The company expects to launch its first product in the EU market and thus to start its turnover. Since the launch occurs just at the end of the year or early next year, in 2020 no substantial turnover is expected. The company's medium-term objectives are
- to generate significant revenue growth as a result of a two-year marketing period
- to become profitable after 4 years
- launch also in the US and many other countries
- develop new products
- establish partnership agreements with industry leaders
Board of Directors guidance for 2020
BBS begins its CE marking submission process in March.
Preparation of the FDA approval submission continues. The goal is to conduct an animal test required by the FDA authorities this year.
The company starts its sales and marketing operation preparation, when the first response from Notified Body has been received.
- Preparations for recruiting marketing staff will begin
- Preparations for the Post market clinical follow up study will begin. The mandatory research is required by medical device regulations.
- Building of a network of key clinical opinion leaders is initiated.
The company will start preparation of production when the first response from Notified Body has been received.
- New staff will be recruited and trained
- New production test rounds are performed to meet the needs of animal testing and subsequent clinical work as well as optimization of production.
The company will organize a share issue during 2020 to enable the realization of the above mentioned objectives.
CEO Ilkka Kangasniemi
Year 2019 was operationally challenging for the company. The authorities' requirement to carry out a supplementary animal experiment to amend its CE marking application caused a delay of more than one year in the submission process. However, this does not affect the performance or safety of the product, which can still be said to be at top level.
A share issue in Swedish Nasdaq First North list was carried out bringing company 0.3 M € in assets and 215 new owners. To be able to execute the next issue of shares boosted by positive news, the company saw it necessary to wait for the clinical report completion, the CE-marking submission and completion of the first interim report on animal testing.
Completion and publication of the clinical report released February 19, 2020 significantly strengthened the company's outlook. For the first time, in 2020 the share price exceeded the IPO level.
The company cash assets were supplemented with 200.000 € as a working capital loan granted by Finha Capital Oy, signed in March 17, 2020. The purpose of the loan is to strengthen the company's liquidity. The loan terms and conditions include an option to convert the loan into shares at the next issue.
Despite the prolonged financial situation, at the end of the fiscal year the company has reached a good position in its aim to move to the next stage of its development. With the new animal test results sufficient documentation can be provided to the authorities for decision making.
The goals for 2019 declared a year ago to begin preparation of marketing and sales functions were transferred forward for the same reason as the regulatory submission process. As a result, this year's targets are almost the same as at the beginning of the previous fiscal year: Completing the EU marketing authorization process and submitting the FDA application. Preparations of marketing and sales operations is initiated, when the authorities give their first, positive, response with questions and comments about the application.
The company has also continued evaluation process with major international players, with the aim to open marketing channels, particularly in the USA, but also in other countries, in areas and that are not BBS's neighboring markets. News of the clinical study outcome has been received positively and expectations to reach next level in the evaluation processes are rising.
Submitting an application for marketing authorization for the first product
The company has during 2019 completed almost all of the required documentation changes that were required by Notified Body to amend the marketing authorization application, submitted in 2018, or by the new medical device regulation. The company has planned to initiate a submission process of a new application to Notified Body in March 2020. However, this schedule will be delayed because the chosen Notified Body (BSI Netherlands) has announced a delay until May 2020, generated by the increased workload for them due to the new medical device regulation.
The regulatory approval process takes place by Notified Body and in addition by the Competent Authority (CA, National Agency for Medicines) for the drug component of the product, by the CA from which Notified Body so requests. Notified Body has 90 days from the filing date to submit questions and comments on the content of the application. The Competent Authority has 110 days to respond. During this processing, the two authorities will decide whether to accept the classification of the product as a medical device and whether the material submitted meets the requirements of the Directives and Standards for such a product. Thus, at the latest after these waiting periods, the company will either receive product approval or be made aware of any deficiencies and repairs required by the authorities.
At the same time, Notified Body audits the company operations and quality system during the spring and summer of 2020 and issues a quality certificate if no objections can be found.
Normally the authorities will always find comments on the small details, that need to be dealt with and accounted for, before final approval can be obtained. A realistic timetable for the CE marking of the product and a quality system certification is thus set for the end of 2020 or early 2021. However, from the first replies we can already learn what kind of comments are involved and thus form a strong sense of the realism of the timetable.
FINANCIAL REVIEW 1 JANUARY - 31 DECEMBER 2019
Overview
BBS owns 100% of the subsidiary Bio Bones Oy, which owns a production facility in Reisjärvi. Bio Bones has no other business.
Operating income and development costs
BBS had no net sales in the review period or in the corresponding period of the previous year. The result for the fiscal period 2019 is lower than the previous one because Other Revenue includes a decision taken in 2018 from Tekes (State funding agency) not to collect old R&D loans of EUR 2.224 million.
Financing and investment
At December 31, 2009, the company's cash and cash equivalents were EUR 0.515 (1.685) million. The company estimates that the current funding will be sufficient for approximately three months from the date of this release. The commencement of production and sales activities, and thus the income generating capacity of the intangible assets capitalized on the balance sheet, depends on the success of raising additional financing.
The Group's cash flow from operating activities for the period under review was EUR -1.444 (-1.701) million.
Acquisitions and directed issues
No acquisitions were made during the review period.
BBS organized a directed share issue in Sweden, the issue ended on 30 June 2019. In the issue, the company received capital of approximately EUR 0.3 million before the issue costs, which were estimated to be approximately EUR 0.05 million. More detailed information on the listing can be found on the company's website.
Balance
The consolidated balance sheet total at December 31, 2019 was EUR 9.833 (11.156) million. At the end of the reporting period, the company had loans from financial institutions totaling EUR 6.152 (6.155) million at the end of the review period, of which short-term loans EUR 0.961 (0.522) million. Capital loan was EUR 0.176 (0.176) million. Financial income and expenses totaled EUR -0.102 (-0.097) million. No capitalized product development investments have been made in the balance sheet during the review period.
Own capital
Shareholders' equity at December 31, 2017 was EUR 3.079 million. In the financial statements as at December 31, 2018, shareholders' equity was EUR 4.416 million. During the review period 2019, a directed issue was conducted to Sweden, generating gross income of EUR 0.3 million. Result for the financial year was EUR -1.638 million.
Personnel and administration
The number of personnel at the end of December 31, 2019 was 12. During the period under review, the Board of Directors comprised Jarmo Halonen (Chairman), Auvo Kaikkonen, Tomi Numminen, Ilkka Kangasniemi, Pekka Jalovaara and Hannu Säynäjäkangas. Pekka Jalovaara served as CEO until October 14, 2019 and Ilkka Kangasniemi served as CEO starting on October 15, 2019.
Annual General Meeting 2019
The Annual General Meeting of BBS Corporation was held in Oulu on 5th of April 2019.
The AGM approved the financial statements for 2018 and discharged the members of the Board of Directors and the CEO from liability. The Annual General Meeting decided in accordance with the Board's proposal, that no dividend be distributed for the financial period 1.1.2018-31.12.2018 and that the loss be recognized in the profit / loss account.
The AGM confirmed the remuneration of the Board members at EUR 500 per meeting and the Chairman EUR 750 per meeting.
The Annual General Meeting decided, that the auditor be paid a reasonable fee against invoice approved by the company. Ernst & Young Oy, an auditing firm, was elected as the auditor of BBS.
The Annual General Meeting decided to authorize the Board of Directors to decide on the issue of shares of 1.500.000 (one and half million) which does not exclude the right of the Board of Directors to decide on a directed share issue. The authorization will be valid until the next Annual General Meeting, however, until the 30th June 2020 at the latest.
Share-based incentive plan
The company has a valid stock option plan 2012 approved by the Annual General Meeting on July 18, 2012. The Board of Directors authorized the Annual General Meeting to decide on stock options on 2nd January 2013. Options have been issued to key personnel and each option entitles its holder to subscribe for one share at a price of one EUR by 31 December 2019. On January 9, 2018, the Board of Directors has extended the subscription period until December 31, 2023. The subscriptions of stock options may amount to a maximum of 170000 new shares and have no appreciable effect on earnings per share.
Risks and uncertainties
The company's risks have recently focused on product approval processes and financial operations. On the approval side, the risk is mainly n keeping timelines, due to the ability of the authority to require additions and corrections to the documentation provided. The product classification is subject to regulatory interpretation. The decision-making will depend on the results of the animal experiment which will be available in the near future. On the US side, the 510(k) certification path that allows predicate use carries a principle risk, but the company's current view is that no difficulty is expected in this respect.
On the financial side, the acute risk is the uncertainty in the stock market caused by the Corona virus. So far, the company's share price has not followed the general trend in stock exchanges. This is understandable as BBS is a long-term investment target as a medical device R&D and production company. The development phase is long, followed by a 4-5 years post-launch marketing and sales growth phase, and finally, once the sales turn profitable, the company will typically continue its profitable growth phase for a long time. The risk of a share issue failure can also be seen as a financial risk. The volatility of the global economic and the falling stock prices may scare investors.
Shares and Shareholders
BBS's market capitalization at the end of the reporting period 31.12.2019 was by 10.4 million euros. The closing price on December 31, 2018 was EUR 2.00. The highest quotation during the review period was EUR 3.75 and the lowest EUR 1.85.
BBS had 1097 registered shareholders at the register of shareholders on December 31, 2019.
As at December 31, 2018, BBS's Board of Directors and CEO owned a total of 543.650 (532.850) shares, including shares held through controlled companies, or 10.4 % of the Company's stock. Information on insider trading in the company's shares is published on the company's website.
Events after the reporting period
February 19, 2020 The company announced the results of clinical trials, more details on the website. Investors saw the news as positive as the company's share price rose sharply.
In early 2020, product and development loans have been restructured. After the arrangement, the share of short-term financial loans will be EUR 0.316 M and the loans maturing in more than five years will be EUR 2.995 M.
In March 17, 2020, the Company decided to take out a working capital loan of EUR 200.000 to ensure its liquidity.
Accounting Policies
The financial statements bulletin has been prepared in accordance with the Finnish Accounting Act and the rules of the First North Marketplace. The figures in the financial statements release are unaudited.
Financial information 2020
Half-year report January-June 2020 made available by 31.8.2020 at 9:00 am.
Oulu, March 20, 2020
BBS-Bioactive Bone Substitutes Plc
Board
For more information:
Ilkka Kangasniemi, CEO,
puh. 040 7080307, e-mail: ilkka.kangasniemi@bbs-artebone.fi
Hannu Säynäjäkangas, CFO,
puh. 040 5021092, e-mail: hannu.saynajakangas@bbs-artebone.fi
Certified Advisor:
Stockholm Certified Advisers AB, p. +46 70 5516 729
DISTRIBUTION:
Nasdaq Helsinki Oy
Nasdaq Stockholm AB
Key media
www.bbs-artebone.fi
This is information that BBS-Bioactive Bone Substitutes Plc is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on 20th March 2020 at 9:00 am (UTC).
BBS-Bioactive Bone Substitutes Plc is the health technology company operating since 2003. Before that there was a background of seven years of product development in the University of Oulu. We have developed a new product for healing of difficult bone fractures and for solving the problems in bone healing. Our mission is to offer new generation medicinal products for the orthopedic surgery. The research and development in the field of medicine requires perseverance and courage to develop new things. We have over 20 years of expertise in this. Our operations are characterized by top expertise, innovativeness and dedicated and committed employees. The ARTEBONE ®product is ready and the application process for the CE marking has been initiated. BBS is the company having its headquarters in Oulu. We have our own production plant located in Reisjärvi and it is approved by FIMEA. More information: www.bbs-artebone.fi.
ATTACHMENTS:
Financial Statement December 31, 2019
Cash Flow Statement December 31, 2019
Statement of changes in equity in the year 2019
Distribution: NASDAQ and key media
ANNUAL REPORT AND BALANCE SHEET BOOK 2019
BBS-BIOACTIVE BONE SUBSTITUTES OYJ
ANNUAL REPORT 1 JANUARY - 31 DECEMBER 2019
Business overview
BBS-Bioactive Bone Substitutes Oyj (“BBS”, “Company”) is a biomedical technology company that develops innovative, bioactive medical devices and implants for orthopaedic surgery. The Company has an administration and quality control laboratory in Oulu and an EU-certified production plant in Reisjärvi.
BBS’s product development
The company has during 2019 completed almost all of the required documentation changes that were required by Notified Body to amend the marketing authorization application, submitted in 2018, or by the new medical device regulation. The company has planned to initiate a submission process of a new application to Notified Body in March 2020. However, this schedule will be delayed because the chosen Notified Body (BSI Netherlands) has announced a delay until May 2020, generated by the increased workload by the new medical device regulation.
The regulatory approval process takes place by Notified Body and in addition by the Competent Authority (CA, National Agency for Medicines) for the drug component of the product, by the CA from which Notified Body so requests. Notified Body has 90 days from the filing date to submit questions and comments on the content of the application. The Competent Authority has 110 days to respond. During this processing, the two authorities will decide whether to accept the classification of the product as a medical device and whether the material submitted meets the requirements of the Directives and Standards for such a product. Thus, at the latest after these waiting periods, the company will either receive product approval or be made aware of any deficiencies and repairs required by the authorities.
At the same time, Notified Body audits the company operations and quality system during the spring and summer of 2020 and issues a quality certificate if no objections can be found.
Normally the authorities will always find comments on the small details, that need to be dealt with and accounted for, before final approval can be obtained. A realistic timetable for the CE marking of the product and a quality system certification is thus set for the end of 2020 or early 2021. However, from the first replies we can already learn what kind of comments are involved and thus form a strong sense of the realism of the timetable.
Financial review
Operating result
BBS had no turnover in 2019 or in the corresponding period of the previous year. The result for the review period was M€ -1.638 (2018: M€ 0.380) which consists of product development costs. The one-time chord (debt forgiveness) of € 2.224 M obtained from loans was the main contribution to the good result of the comparison period.
Financing and investments
The Company’s finances at 31 December 2019 were € 515.633 (2018: € 1.684.871). BBS organized a directed share issue in Sweden which ends 30th June 2019 The company received M€ 0,3 new capital from the issue prior the issuance expences of approximately M€ 0,05. In the issue, 114.300 new shares were subscribed. The authorization granted by the Annual General Meeting on 5th April 2019, has 1.385.700 million shares outstanding. More detailed information on share issue is available on the Company’s website.
Working capital
The Company's working capital is not sufficient to complete the approval processes, start production and start commercial operations, if the Company fails to raise equity financing or debt financing a total of approximately EUR 3-5,0 million. Start-up of production and sales activities, and hence the profitability of intangible assets activated in the balance sheet, depends on success in obtaining additional funding.
Up until now, the Company has been in the product development stage, and operating cash flow cannot be generated until it has received the CE mark for its main product. The CE mark is required for selling the Company’s main product. The Company estimates the operating costs are EUR 1.4-1.6 million for the next 12 months. The Company’s estimated repayment for the loans during the corresponding period is EUR 0.219 million, and the Company's planned investments in business activities are EUR 0.3 million.
The Company has negotiated additional payment time for the product development loan repayments in early 2020. The creditors have provisionally agreed to postpone the repayments by one year. The Company’s management estimates that by savings will have sufficient working capital for the next 3 months but is preparing for additional funding. The Company’s management can influence the amount of investments and expenses to be made.
Balance sheet
The balance sheet total at 31 December 2019 was € 9.833 M. The balance sheet total at the end of the previous review period at 31 December 2017 was € 9.669 M. The change is mainly due the decrease in cash reserves and depreciation. At the end of the review period at 31 December 2019, the short-term interest-bearing debts on the balance sheets stood at € 0.961 M (2018: € 0.522 M), long-term interest-bearing debts € 5,191 M (2018: € 5.633 M) and subordinated loans EUR 0,176 (2018: € 0.176 M) million. The financing costs were € 102.2 thousand (2018: € 97.6 thousand). No product development investments have been capitalised in the balance sheet during the review period.
Staff, management and administration
At the end of the 2019 financial period, the staff numbered 12 (2018:13). During the review period, the Board of Directors consisted of Jarmo Halonen, Pekka Jalovaara, Auvo Kaikkonen, Hannu Säynäjäkangas, Ilkka Kangasniemi and Tomi Numminen. BBS’s management team consists of CEO Pekka Jalovaara until 14th Oct 2019 and Ilkka Kangasniemi since 15th Oct 2019, Production Manager Hanna Tölli and CFO Hannu Säynäjäkangas. Ernst&Young Oy acted as auditor, *Juhani Rönkkö has been the principal auditor until the end of august 2019 and from beginning of September 2019 *Jari Karppinen. (*Auditor certified by the Central Chamber of Commrece*)
2019 Annual General Meeting (AGM)
BBS’s AGM was held on 5th March 2019. The AGM approved the financial statements for 2018 and discharged the members of the board of directors and the CEO from liability. In accordance with the proposal by the Board of Directors, the AGM decided that no dividend is paid for the financial year 1 January 2018 - 31 December 2018, and that the loss for the financial year is recognised in the profit/loss account. The AGM confirmed the board member’s remuneration of EUR 500 per meeting and the chairman EUR 750 per meeting. The AGM decided that the auditor will be paid a reasonable fee according to the invoice approved by Company. Ernst&Young Oy, Authorized Public Accountants, was elected as the Company’s auditor.
The Annual General Meeting decided to authorize the Board of Directors to decide on the issue of shares which does not exclude the right of the Board of Directors to decide on a directed share issue. The share issue may be effecyed by an increase in the share capital, a rights issue or a convertible loan in one or more tranches. Under the authorization, the BOD may offer up to 1.500.000 (one million and five hundred thousand) new shares. The authorization will be valid until the next Annual General Meeting, however, until the 30th June 2020 at the latest.
Risks and uncertainties
Significant risks and uncertainties independent of the Company, such as actions by authorities, legislative changes and the desire of the market to receive a new product, are associated with product development and commercialisation. It is not certain that the capitalisations and established losses can be utilised. There are uncertainties which may delay obtaining a sales permit regarding the sufficiency of financing.
Shares and shareholders
BBS had 1097 shareholders, all shares are of the same series and there were 5 204 820 registered shares (2018: 5 090 520) at the balance sheet date on 31 December 2019. Each share is entitled to one vote. The Company’s Board of Directors and the President and CEO owned 31th December 2019 of a total of 543 650 (532 650) shares, including control of shares owned by companies, ie 10,4% of the Company’s share capital. Information on the Company’s insider trading in the Company’s shares is published on the Company’s website. 170 000 stock options have been given to staff, each option entitles to subscribe for one share. The largest shareholders at 31 December 2019 were Finha Capital (860 501 shares), Reisjärvi municipality (702 182 shares), EAKR-aloitusrahasto Oy (596 271 shares), Pekka Jalovaara (532 850 shares), Paananen Ahti (267 879 shares), Irma Halonen (295 421 shares), Panvest Oy (244 142) and Innovestor Kasvurahasto I Ky (229 094 shares).
The Oulu Wellness Fund owned 260.000 shares, the Fund’s term of office came to an end and the company was dissolved. On November 12th 2019 the Fund’s shares were distributed to investors of the fund, the largest owner of which is the City of Oulu 130 081 shares.
The Company’s market capitalization at the end of the review period 31th December 2019 was EUR 10.4 million. The share closed 31th December 2019 at EUR 2.00. The highest price during the review period was EUR 3,75 and the lowest EUR 1.85.
Events after the balance sheet date
In February 19, 2020 the Company announced the results of clinical trials, more details on the website. Investors saw the news as positive as the Company’s share price rose sharply.
In early 2020, product and development loans have been restructured. After the arrangement, the share of short-term financial loans will be EUR 0,316 M and the loans maturing in more than five years will be EUR 2.995 M.
In March 2020, the Company decided to take out a working capital loan of EUR 200.000 to ensure its liquidity.
The Board of Directors’ dividend proposal to the 2018 Annual General Meeting
At the balance sheet date, BBS had no distributable funds, so the Company's Board of Directors proposes that no dividend is distributed for the financial year 1 January - 31 December 2019.
Outlook for 2020
During this year, the Company’s objective is to obtain the CE marking and launch commercial efforts. In order to secure funding, BBS will organize a financing round during 2020. Staff will be added to the sales organisation as resources allow.
Board of Directors
| BBS-Bioactive Bone Substitutes Plc | ||||||
| CONSOLIDATED INCOME STATEMENT | 1.1.-31.12.2019 | 1.1.-31.12.2018 | ||||
| SALES | 0,00 | 0,00 | ||||
| * Other operating income | 52 775,85 | 2 262 011,03 | ||||
| Materials and services | ||||||
| Raw material and consumables | ||||||
| Purchase during the period | -11 047,22 | -58 302,16 | ||||
| External services | -94 641,70 | -69 956,73 | ||||
| Raw materials and services total | -105 688,92 | -128 258,89 | ||||
| Personnel expenses | ||||||
| Wages and salaries | -568 867,89 | -576 744,28 | ||||
| Social security expenses | ||||||
| Pension expenses | -83 042,60 | -84 065,19 | ||||
| Other personnel expenses | -13 101,44 | -9 026,53 | ||||
| Personnel expenses total | -665 011,93 | -669 836,00 | ||||
| Depreciation and amortization | ||||||
| Depreciation according to plan | -225 417,46 | -229 029,43 | ||||
| Impairment of non-current assets | 0,00 | 0,00 | ||||
| Depreciation and amortization total | -225 417,46 | -229 029,43 | ||||
| Other operating expenses | -592 597,71 | -757 410,10 | ||||
| OPERATING PROFIT (LOSS) | -1 535 940,17 | 477 476,61 | ||||
| Financial income and expenses | ||||||
| Other interest income and other financing income | ||||||
| From others | 0,27 | 1,80 | ||||
| Other interest and financial expenses | ||||||
| To others | -102 210,21 | -97 638,60 | ||||
| Financial income and expenses total | -102 210,21 | -97 636,80 | ||||
| PROFIT (LOSS) BEFORE APPROPRIATIONS AND TAXES | -1 638 150,11 | 379 839,81 | ||||
| PROFIT (LOSS) OF THE FINANCIAL PERIOD | -1 638 150,11 | 379 839,81 | ||||
| BBS-Bioactive Bone Substitutes Plc | |||||
| CONSOLIDATED BALANCE SHEET | 31.12.2019 | 31.12.2018 | |||
| ASSETS | |||||
| NON-CURRENT ASSETS | |||||
| Intangible assets | |||||
| Development expenditure | 7 532 827,55 | 7 532 827,55 | |||
| Other Intangible assets | 359 254,72 | 433 289,14 | |||
| Intangible assets total | 7 892 082,27 | 7 966 116,69 | |||
| Tangible assets | |||||
| Land and water areas | |||||
| Owned buildings | 83 719,00 | 83 719,00 | |||
| Buildings and structures | |||||
| Owned buildings and structures | 515 519,24 | 554 321,76 | |||
| Machinery and equipment | 624 977,83 | 773 860,95 | |||
| Tangible assets total | 1 284 216,07 | 1 411 901,71 | |||
| NON-CURRENT ASSETS TOTAL | 9 176 298,34 | 9 378 018,40 | |||
| CURRENT ASSETS | |||||
| Debtors | |||||
| Short term | |||||
| Other debtors | 140 881,37 | 93 416,69 | |||
| Prepayments and accrued income | 0,00 | 0,00 | |||
| Short term debtors total | 140 881,37 | 93 416,69 | |||
| Debtors total | 140 881,37 | 93 416,69 | |||
| Cash and equivalents | 515 633,39 | 1 684 870,70 | |||
| CURRENT ASSETS TOTAL | 656 514,76 | 1 778 287,39 | |||
| ASSETS TOTAL | 9 832 813,10 | 11 156 305,79 | |||
| BBS-Bioactive Bone Substitutes Plc | |||||
| CONSOLIDATED BALANCE SHEET | 31.12.2019 | 31.12.2018 | |||
| EQUITY AND LIABILITIES | |||||
| CAPITAL AND RESERVES | |||||
| Equity | |||||
| Share capital | 80 000,00 | 80 000,00 | |||
| Equity total | 80 000,00 | 80 000,00 | |||
| Share premium account | 1 394 957,01 | 1 394 957,01 | |||
| Other reserves | |||||
| Invested unrestricted equity fund | 11 638 453,75 | 11 337 847,26 | |||
| Other reserves total | 11 638 453,75 | 11 337 847,26 | |||
| Retained earnings (loss) | -8 396 062,95 | -8 775 902,76 | |||
| Profit (loss) of the period | -1 638 150,11 | 379 839,81 | |||
| CAPITAL AND RESERVES TOTAL | 3 079 197,70 | 4 416 741,32 | |||
| CREDITORS | |||||
| Long term | |||||
| Capital loans | 175 825,46 | 175 825,46 | |||
| Loans from credit institutions | 5 191 297,00 | 5 633 425,33 | |||
| Long term loans total | 5 367 122,46 | 5 809 250,79 | |||
| Short term | |||||
| Loans from credit institutions | 961 473,00 | 521 664,67 | |||
| Trade creditors | 31 879,90 | 20 923,70 | |||
| Other creditors | 27 293,22 | 13 485,30 | |||
| Accrual and referred income | 365 846,82 | 374 240,01 | |||
| Short term creditors total | 1 386 492,94 | 930 313,68 | |||
| CREDITORS TOTAL | 6 753 615,40 | 6 739 564,47 | |||
| EQUITY AND LIABILITIES TOTAL | 9 832 813,10 | 11 156 305,79 | |||
| BBS-Bioactive Bone Substitutes Plc | ||||||
| PARENT COMPANY’S INCOME STATEMENT | 1.1.-31.12.2019 | 1.1.-31.12.2018 | ||||
| SALES | 0,00 | 0,00 | ||||
| * Other operating income | 52 775,85 | 2 261 380,31 | ||||
| Materials and services | ||||||
| Raw material and consumables | ||||||
| Purchase during the period | -11 047,22 | -58 302,16 | ||||
| External services | -94 641,70 | -69 956,73 | ||||
| Raw materials and services total | -105 688,92 | -128 258,89 | ||||
| Personnel expenses | ||||||
| Wages and salaries | -568 867,89 | -576 744,28 | ||||
| Social security expenses | ||||||
| Pension expenses | -83 042,60 | -84 065,19 | ||||
| Other personnel expenses | -13 101,44 | -9 026,53 | ||||
| Personnel expenses total | -665 011,93 | -669 836,00 | ||||
| Depreciation and amortization | ||||||
| Depreciation according to plan | -182 968,36 | -182 444,17 | ||||
| Impairment of non-current assets | 0,00 | 0,00 | ||||
| Depreciation and amortization total | -182 968,36 | -182 444,17 | ||||
| Other operating expenses | -620 208,22 | -788 234,64 | ||||
| OPERATING PROFIT (LOSS) | -1 521 101,58 | 492 606,61 | ||||
| Financial income and expenses | ||||||
| Other interest income and other financing income | ||||||
| From others | 0,25 | 1,71 | ||||
| Other interest and financial expenses | ||||||
| To others | -75 876,95 | -75 441,62 | ||||
| Financial income and expenses total | -75 876,95 | -75 441,62 | ||||
| PROFIT (LOSS) BEFORE APPROPRIATIONS AND TAXES | -1 596 978,28 | 417 166,76 | ||||
| PROFIT (LOSS) OF THE FINANCIAL PERIOD | -1 596 978,28 | 417 166,76 | ||||
| BBS-Bioactive Bone Substitutes Plc | |||||
| PARENT COMPANY’S BALANCE SHEET | 31.12.2019 | 31.12.2018 | |||
| ASSETS | |||||
| NON-CURRENT ASSETS | |||||
| Intangible assets | |||||
| Development expenditure | 7 532 827,55 | 7 532 827,55 | |||
| Other Intangible assets | 359 254,72 | 433 289,14 | |||
| Intangible assets total | 7 892 082,27 | 7 966 116,69 | |||
| Tangible assets | |||||
| Machinery and equipment | 674 038,17 | 759 274,71 | |||
| Land and water areas | |||||
| Shares in the same group of companies | 714 499,55 | 714 499,55 | |||
| NON-CURRENT ASSETS TOTAL | 9 280 619,99 | 9 439 890,95 | |||
| CURRENT ASSETS | |||||
| Debtors | |||||
| Short term | |||||
| Other debtors | 140 881,37 | 93 416,69 | |||
| Prepayments and accrued income | 0,00 | 0,00 | |||
| Short term debtors total | 140 881,37 | 93 416,69 | |||
| Debtors total | 140 881,37 | 93 416,69 | |||
| Cash and equivalents | 487 027,18 | 1 664 343,16 | |||
| CURRENT ASSETS TOTAL | 627 908,55 | 1 757 759,85 | |||
| ASSETS TOTAL | 9 908 528,54 | 11 197 650,80 | |||
BBS-Bioactive Bone Substitutes Plc | |||||
| PARENT COMPANY’S BALANCE SHEET | 31.12.2019 | 31.12.2018 | |||
| EQUITY AND LIABILITIES | |||||
| CAPITAL AND RESERVES | |||||
| Equity | |||||
| Share capital | 80 000,00 | 80 000,00 | |||
| Equity total | 80 000,00 | 80 000,00 | |||
| Share premium account | 1 394 957,01 | 1 394 957,01 | |||
| Other reserves | |||||
| Invested unrestricted equity fund | 11 638 453,75 | 11 337 847,26 | |||
| Other reserves total | 11 638 453,75 | 11 337 847,26 | |||
| Retained earnings (loss) | -7 814 126,82 | -8 231 293,58 | |||
| Profit (loss) of the period | -1 596 978,28 | 417 166,76 | |||
| CAPITAL AND RESERVES TOTAL | 3 702 305,21 | 4 998 677,00 | |||
| CREDITORS | |||||
| Long term | |||||
| Capital loans | 175 825,46 | 175 825,46 | |||
| Loans from credit institutions | 4 613 829,00 | 5 312 591,34 | |||
| Long term loans total | 4 789 654,46 | 5 488 416,80 | |||
| Short term | |||||
| Loans from credit institutions | 897 273,00 | 200 830,66 | |||
| Trade creditors | 127 240,45 | 123 558,43 | |||
| Other creditors | 26 274,19 | 13 289,63 | |||
| Accrual and referred income | 365 781,23 | 372 878,28 | |||
| Short term creditors total | 1 416 568,87 | 710 557,00 | |||
| CREDITORS TOTAL | 6 206 223,33 | 6 198 973,80 | |||
| EQUITY AND LIABILITIES TOTAL | 9 908 528,54 | 11 197 650,80 | |||
| BBS-BIOACTIVE BONE SUBSTITUTES OYJ | ||||||||
| Kiviharjunlenkki 6 | ||||||||
| 90220 Oulu | ||||||||
| Y-tunnus 0866451-4 | ||||||||
| Notes to the Financial Statements | ||||||||
| The financial statements have been prepared in accordance with the Small Business Act (SBA) | ||||||||
| Code for the disclosure of small and micro enterprises | ||||||||
| The group owns 100% of its subsidiary Bio Bones Oy. Bio Bones Oy's business area is to own and rent | ||||||||
| production facilities in Reisjärvi | ||||||||
| Notes to the income statement | ||||||||
| An explanation of the reasons for the planned depreciation and its changes | ||||||||
| Machinery and equipment acquired for Native III and IV are amortized over 10 years on a straight-line basis | ||||||||
| Depreciation started in January 2017 | ||||||||
| Other machines and equipment are removed in accordance with EVL-tax maximum depreciation rates | ||||||||
| Cleanroom native project is depreciated by 10 years straight-line depreciation. Started in january 2017 | ||||||||
| The additional investments/renovation cost of Reisjärvi production facilities will be amortized over 5 years | ||||||||
| Planned depreciations | 31.12.2019 | 31.12.2018 | ||||||
| Machinery and equipments | 112 580,52 | 113 271,85 | ||||||
| Buildings and structures | 38 802,52 | 41 723,16 | ||||||
| Other long term expenses | 74 034,42 | 74 034,42 | ||||||
| Other income | ||||||||
| Tekesin hyväksymä lainojen akordi, 2.224.150,54 eur, kirjattu liiketoiminnan muihin tuottoihin vuonna 2018. | ||||||||
| Notes to the Balance Sheet | ||||||||
| Intangible assets | ||||||||
| Development costs, including salaries, for capitalized projects | ||||||||
| Native project | Clinical project | |||||||
| Opening balance 1.1.2019 | 6 369 319,10 | 1 163 508,45 | ||||||
| Balance 31.12.2019 | 6 369 319,10 | 1 163 508,45 | ||||||
| Native project product development completion date was Feb 2015, the project continued as a clinical project, | ||||||||
| which was completed in Dec 2017. Activations have not been depreciated. | ||||||||
| Depreciation will begin when the sale begins. The estimated depreciation period is 5 years. | ||||||||
| Other long term expenses | ||||||||
| Additional investments in Reisjärvi | Clean room Native project | |||||||
| Opening balance 1.1.2019 | 22 712,30 | 410 576,84 | ||||||
| depreciation during the financial year | 22 712,30 | 51 322,12 | ||||||
| Balance 31.12.2019 | 0,00 | 359 254,72 | ||||||
| Intangiblle assets total | 7 892 082,27 | |||||||
| Among non-current assets a total o EUR 7.336.237,49 in equipment development costs and clean room | ||||||||
| premises, including project machinery and equipment and the cost of continuing Clinical project of EUR | ||||||||
| 1.163.508,45 have been capitalized to non-current assets | ||||||||
| The capitalization of the Reisjärvi production facilities and additional investmentsin the process was | ||||||||
| completed during 2019. | ||||||||
| BBS-BIOACTIVE BONE SUBSTITUTES OYJ | ||||||||
| Kiviharjunlenkki 6 | ||||||||
| 90220 Oulu | ||||||||
| Y-tunnus 0866451-4 | ||||||||
| Capital loans | ||||||||
| Tekes/Valtiokonttori | 175 825,46 | |||||||
| Debts, that fall due after more than five years | ||||||||
| Valtiokonttori/Tekes 160/09 | 307 367,00 | |||||||
| Valtiokonttori/Tekes 363/15 | 113 880,00 | |||||||
| Finnvera 1012867 | 138 690,00 | |||||||
| Finnvera 1012865 | 320 668,00 | |||||||
| Debts, events after the financial year | ||||||||
| In early 2020, a change was made to Valtiokonttori/Tekes loans. As a result, short term debt is reduced by | ||||||||
| EUR 644.930,00 and debt maturing later than five years increased by EUR 2.114.701,00 | ||||||||
| After the arrangement, the share of short term financing loans is EUR 316.543,00 | ||||||||
| and liabilities maturing later than five years are total EUR 2.995.306,00 | ||||||||
| In addition, a EUR 200.000 working capital loan has been taken out after the end of the financial year. | ||||||||
| Breakdown of equity | 31.12.2019 | 31.12.2018 | ||||||
| Share capital at the beginning of the financial year | 80 000,00 | 80 000,00 | ||||||
| Share capital at the end of the financial year | 80 000,00 | 80 000,00 | ||||||
| The share premium account | 1 394 957,01 | 1 394 957,01 | ||||||
| Total equity | 1 474 957,01 | 1 474 957,01 | ||||||
| Invested unrestricted equity fund at the beginning of the f.y. | 11 337 847,26 | 7 836 992,76 | ||||||
| Increase in the invested unrestricted equityfund during the f.y. | 300 606,49 | 3 500 854,50 | ||||||
| Invested unrestricted equity fund at the end of the f.y. | 11 638 453,75 | 11 337 847,26 | ||||||
| result for previous financial years | -8 396 062,95 | -8 775 902,76 | ||||||
| Result of the financial year | -1 638 150,11 | 379 839,81 | ||||||
| Total unrestricted equity | 1 604 240,69 | 2 941 784,31 | ||||||
| Total equity | 3 079 197,70 | 4 416 741,32 | ||||||
| Capital loan Tekes/Valtiokonttori | 175 825,46 | 175 825,46 | ||||||
| Equity + capital loans | 3 255 023,16 | 4 592 566,78 | ||||||
| Distributable unrestricted equity | ||||||||
| The invested unrestricted equity fund | 11 638 453,75 | |||||||
| Results of the previous financial years | -8 396 062,95 | |||||||
| Result of the finacial year | -1 638 150,11 | |||||||
| Capitalized development costs in the balance sheet | -7 532 827,55 | |||||||
| Distributable unrestricted equity 31th Dec 2019 | -5 928 586,86 | |||||||
| At the balance sheet date, the parent company has 5.204.820 registered shares and 170.000 registered options | ||||||||
| Each share entitles its holder to one vote at the General Meeting. | ||||||||
| At its meeting on April 27, 2018, the BOD has extended the subscription period until the end of the year 2023 | ||||||||
| Accrued unpaid interest | ||||||||
| Capital loan | ||||||||
| Tekes/Valtiokonttori 9.3.-31.8.2005 | 2 505,51 | |||||||
| Tekes/Valtiokonttori 1.9.2005-31.8.2006 | 5 274,75 | |||||||
| Tekes/Valtiokonttori 1.9.2006-31.8.2007 | 5 348,02 | |||||||
| Tekes/Valtiokonttori 1.9.2007-31.8.2008 | 6 300,40 | |||||||
| Tekes/Valtiokonttori 1.9.2008-31.8.2009 | 6 593,44 | |||||||
| Tekes/Valtiokonttori 1.9.2009-31.8.2010 | 5 274,75 | |||||||
| Tekes/Valtiokonttori 1.9.2010-31.8.2011 | 5 274,76 | |||||||
| BBS-BIOACTIVE BONE SUBSTITUTES OYJ | ||||||||
| Kiviharjunlenkki 6 | ||||||||
| 90220 Oulu | ||||||||
| Y-tunnus 0866451-4 | ||||||||
| Tekes/Valtiokonttori 1.9.2011-31.8.2012 | 5 274,76 | |||||||
| Tekes/Valtiokonttori 1.9.2012-31.12.2013 | 7 033,01 | |||||||
| Tekes/Valtiokonttori 1.1.-31.12.2014 | 5 274,75 | |||||||
| Tekes/Valtiokonttori 1.1.-31.12.2015 | 5 274,75 | |||||||
| Tekes/Valtiokonttori 1.1.-31.12.2016 | 5 274,75 | |||||||
| Tekes/Valtiokonttori 1.1.-31.12.2017 | 5 474,75 | |||||||
| Tekes/Valtiokonttori 1.1.-31.12.2018 | 5 274,76 | |||||||
| Tekes/Valtiokonttori 1.1.-31.12.2019 | 5 274,76 | |||||||
| Due to the loan forgivness by Tekes 2018, the unpaid interest decreased in the same proportion | ||||||||
| Collateral and contingent liabilities in the notes | ||||||||
| Debts secured by a business mortgage | ||||||||
| Corporate mortgages EUR 800.000 related to Finnvera loans totaling EUR 919.358,00 | ||||||||
| Notes on the members and staff of the institutions | ||||||||
| Average number of employeers during the financial year | ||||||||
| 31.12.2019 | 31.12.2018 | |||||||
| Personnel | 12 | 13 | ||||||
| Unrecognized deferred tax assets | ||||||||
| The Group has a tax loss of approximately EUR 7,41 million, of which a hidden tax claim at a current | ||||||||
| rate of 20% is approximately EUR 1,48 million. | ||||||||
| Other notes | ||||||||
| At the balance sheet date, the parent company invested a total of EUR 3.255.023,16 in equity and subordinated debt. | ||||||||
| The subordinated loan includes a subordinated loan of EUR 175.825,46 granted by Tekes. | ||||||||
| Active efforts are still being made to raise both equity and non-equity financing | ||||||||
| The Company's working capital will not be sufficient to complete the approval process, start production and | ||||||||
| commercial operations if the company fails to raise approximately EUR 3-5 million in equity or debt financing. | ||||||||
| The commencement of production and sales activities, and thus the return on intangible assets capitalized | ||||||||
| on the balance sheet, is dependent on success in obtaining additional financing. | ||||||||
| BBS-Bioactive Bone Substitutes Plc Concern Cash Flow Statement | ||||||||
| [1000 euros] | 2019 | 2018 | ||||||
| Cash flow from business operations | ||||||||
| Profit (loss) before extraordinary items | -1638 | 380 | ||||||
| Adjustments | ||||||||
| Scheduled depreciation and amortization | 225 | 229 | ||||||
| Financial income and expenses | 102 | 98 | ||||||
| Other adjustments: Accord of loans | 0 | -2224 | ||||||
| Other adjustments: Write-downs | 0 | 0 | ||||||
| Cash flow before changes in working capital | -1311 | -1517 | ||||||
| Change in working capital | ||||||||
| Changes in short-term non-interest-bearing (+) (-) | -47 | -33 | ||||||
| Changes in inventory Increase(-)/Decrease(+) | 0 | 0 | ||||||
| Changes in short-term non-interest-bearing loans Increase(+)/Decrease(-) | -18 | -45 | ||||||
| Cash flow from business operations before financial items and taxes | -1340 | -992 | ||||||
| Interest paid and other financial expenses from business operations | 104 | 106 | ||||||
| Interest received and other financial income from business operations | 0 | 0 | ||||||
| Cash flow before extraordinary items and taxes | -1444 | -1701 | ||||||
| Cash flow from business operations (A) | -1444 | -1701 | ||||||
| Cash flow from investments | ||||||||
| Investments in tangible and intangible goods | -24 | -34 | ||||||
| Investments in shares in subsidiaries | 0 | 0 | ||||||
| Loans granted | 0 | 0 | ||||||
| Cash flow from investments (B) | -24 | -34 | ||||||
| Cash flow from financing | ||||||||
| Share issue | 301 | 3501 | ||||||
| Raised long-term loans | 0 | 0 | ||||||
| Repayment of long-term loans | 2 | 16 | ||||||
| Raised short-term loans | 0 | 0 | ||||||
| Repayment of short-term loans | 0 | 100 | ||||||
| Cash flow from financing (C) | 299 | 3385 | ||||||
| Changes in funds (A+B+C) Increase (+)/Decrease (-) | -1169 | 1650 | ||||||
| Funds at the beginning of the financial period | 1685 | 35 | ||||||
| Funds at the end of the financial period | 516 | 1685 | ||||||
Equity development
| BBS Group | |||||
| Share Capital | The share premium account | The invested Unresticted equity fund | Retained earnings | Total Equity | |
| Equity 31.12.2018 | 80 000 | 1 395 000 | 11 338 000 | -8 396 000 | 4 417 000 |
| Net profit/loss of f.y. | -1 638 000 | ||||
| Paid share issue | 300 000 | ||||
| Equity 31.12.2019 | 80 000 | 1 395 000 | 11 638 000 | -10 034 000 | 3 079 000 |
| Equity 31.12.2017 | 80 000 | 1 394 957 | 7 836 993 | -8 775 903 | 536 047 |
| Net profit/loss of f.y. | 379 840 | ||||
| Paid share issue | 3 500 855 | ||||
| Equity 31.12.2018 | 80 000 | 1 394 957 | 11 337 847 | -8 396 063 | 4 416 741 |
| Equity 31.12.2016 | 27 984 | 1 394 957 | 6 977 189 | -4 309 588 | 4 090 542 |
| Net profit/loss of f.y. | -4 466 315 | ||||
| Paid share issue | 52 016 | 859 804 | |||
| Equity 31.12.2017 | 80 000 | 1 394 957 | 7 836 993 | -8 775 903 | 536 047 |