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Pixium Vision announces its 2018 annual results and provides business update
- PRIMA clinical performance exceeded initial expectations in advanced dry-AMD;
- Positive feasibility study results to enable the European pivotal trial, the next step to market for PRIMA;
- Significant reduction in 2018 Operating cash consumption;
- 2018 closing cash position: € 15.6 million.
Paris, France, February 8, 2019 – 7.00 AM CET - Pixium Vision (FR0011950641 - PIX), a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced today its 2018 financial results. The board of directors of Pixium Vision approved the annual results at the meeting held on February 7, 2019.
Khalid Ishaque, Chief Executive Officer Pixium Vision stated: “The clinical safety and performance achieved to date with PRIMA in patients with advanced dry-AMD, exceeded the initial expectations. Beyond eliciting light perception in the central area of the retina that had no remaining perception, PRIMA enabled patients to progressively identify letters and sequence of letters. These positive results support the decision to no longer pursue any IRIS® system development, and exclusively focus all our efforts on unlocking PRIMA’s broader potential and value, both for vision loss patients, as well as our shareholders.” Khalid Ishaque added: “2018 was a pivotal year with PRIMA, focused on R&D and clinical efforts, delivering remarkable first clinical results, along with lowering our overall cost base, while maintaining our financial flexibility. The 2019 key goal is to initiate the European pivotal clinical trial with PRIMA. The team is energized to successfully execute this key next development phase for PRIMA on the path to market.”
2018 annual results – Summary
|P&L 2018 – Highlights|
|In thousand euros||2018||2017|
|Revenue / other revenues||1,598.3||2,535.3||2,535.3|
|Cost of Goods Sold||(41.2||)||(1,124.4||)||(1,253.9||)|
|Research and Development||(6,183.6||)||(7,817.4||)||(8,486.2||)|
|Marketing & Communication||(101.8||)||(530.7||)||(530.7||)|
|General and Administrative||(2,797.9||)||(4,125.2||)||(4,930.6||)|
|Adjusted Operating income||(7,526.1||)||(11,062.4||)||-|
|Earnings per share||(0.73||)||(1.02||)||(1.02||)|
(*) Adjusted operating income: The operating income was adjusted for non-cash items related to charge for share-based compensation and loss of value registered in 2018.
|Cash-flow statement summary|
|in thousand euros||2018||2017|
|Opening cash and cash equivalents||10,531.6||14,244.2|
|(Decrease) / Increase in cash position||5,097.8||(3,712.6||)|
|O/W net cash flows from operating activities||(7,450.3||)||(11,480.7||)|
|O/W net cash flows from investing activities||9.0||(402.3||)|
|O/W net cash flows from financing activities||12,539.1||8,170.4|
|Closing cash and cash equivalents||15,629.4||10,531.6|
In 2018, Pixium Vision continued to develop its PRIMA bionic vision system, including the subretinal and wireless photovoltaic implantable microchip, initially for treatment of advanced dry form of Age-related macular degeneration (AMD). In France, all 5 patients planned in the feasibility trial were successfully implanted. In the separate FDA approved Early Feasibility Study, in the United States, recruitment is now fully active. Pixium Vision recently announced 6-month results that exceeded initial expectations for the five patients successfully implanted in France: all implanted patients confirmed light perception with PRIMA from atrophic central retina; with rehabilitation, majority of the patients progress to identify letters and sequences of letters. The adverse events, mainly non-serious, were successfully treated, and the device and procedure preserved the residual natural peripheral visual acuity. The positive interim results enable Pixium Vision to design and implement the multicenter pivotal clinical study in Europe, required for CE mark on the path to market.
The sub-retinal PRIMA Bionic Vision System is intended to address the significant unmet medical need globally for more than 5 million1 people with advanced atrophic dry-AMD and associated loss of central vision, for whom there is no proven or curative therapeutic treatment at this time.
Positive results from PRIMA feasibility study and its potential for value creation, initially being evaluated in the dry form of AMD, also contributed to the company’s decision to no longer pursue further development of its IRIS® system and exclusively focus resources in development of PRIMA with its broader potential. Consequently, the company recorded impairment of tangible and intangible assets as well as inventories related to the IRIS® system.
In 2018, implementation of the restructuring plan enabled Pixium Vision to successfully reduce its operating cash consumption by more than € 4 million, or 35% as compared to 2017. Investments in R&D were preserved and accounted for more than two-thirds of operational expenditures. Pixium Vision also secured additional financing through a capital increase and the use of an equity line. The latter was renewed at the end of 2018. In summary, Pixium Vision maintains financial flexibility to pursue the development of PRIMA.
2019 operational outlook
In 2019, thanks to the positive results of the feasibility study, Pixium Vision will prepare the European pivotal clinical study, expected to begin by the end of the current fiscal year. This trial will be a major milestone in the clinical development plan of PRIMA in advance dry-AMD. Separately for the clinical and regulatory pathway in the USA, recruitment is now fully active for the Early Feasibility Study approved by the FDA and implantations are expected during the first half of the year.
2018 full-year annual results
In 2018, the Company did not generate sales.
Total revenues are mainly composed of the Crédit Impôt Recherche (CIR) research tax credit, which amounted to €1.32 million (€2.06 million in 2017). The CIR is related to a continued R&D effort, notably with the clinical and regulatory expenses on PRIMA. The decrease in CIR in 2018 is due to the cash payment of a refundable advance from “Sight Again”. Excluding this payment, the CIR would have been stable year on year showing unchanged eligible R&D expenses among a significant drop of charges. The Company accounted for a product linked with the refundable advance received in the framework of the “Sight Again” project. In all, total revenues amounted to €1.60 million in 2018 compared with €2.53 million in 2017.
Research & Development (R&D) expenses amounted to €6.18 million in 2018 versus €7.82 million a year earlier. In 2018, Pixium Vision maintained its investments in the development of its bionic vision system PRIMA aiming to pursue both the technical development of PRIMA and running the feasibility clinical studies. The drop in R&D expenses is explained by not renewed regulatory and clinical spending following 2017 milestones achievement.
General & Administrative (G&A) expenses amounted to €2.80 million in 2018 compared with €4.13 million in 2017. The decrease by more than 30% is the consequence of the cost cutting plan and the focus to R&D expenses. Lowered rentals costs, as well as dropped communication and consultancy fees are the main sources of cost savings.
Cost of Goods Sold and Marketing & Communication expenses amounted respectively to €41,172 and €101,829 in 2018 since there is no commercial activities.
The Company has chosen to report its Adjusted Operating Result to improve the readability of the recurring operating items. Non-recurring items with no cash impact are excluded from the Adjusted Operating Result which amounted to a loss of €7.53 million (versus a loss of €11.06 million in 2017). The tight control in operating expenses explained the improvement by 32% of the adjusted Operating Result.
Non-recurring items amounted to €4.77 million of which €5.48 million corresponds to the impairment of tangible and intangible IRIS®-related assets, partially offset by the share-based payment. The non-recurring items are non-cash items.
Net Operating Income amounted to a loss of €12.29 million (vs. a loss of €12.67 million in 2017), and the Net Profit to a loss €13.57 million (vs. a loss of €13.54 million in 2017). In 2018, the Company booked a financial charge of €1.28 million (vs. €0.88 million in 2017) mainly due to interest payment of the venture loan signed with Kreos Capital in September 2016. No Income Tax was recorded in 2018. Net Loss per issued share (weighted average number of shares outstanding over the period) amounted to (€0.73) in 2018 compared to (€1.02) in 2017.
Cash consumption from operating activities dropped by 35% in 2018 to €7.45 million compared with €11.48 million in 2017. Cash consumption was mainly related to the company’s R&D efforts to support the development of the PRIMA bionic vision system. The drop of cash consumption is mainly due to reduced non-R&D expenses.
Net cash flow from financing activities amounted to €12.54 million in 2018. Cash inflow resulted in the capital increase achieved in the first half of 2018, the equity line financing and the receipt of “Sight Again” refundable advance. In parallel, Pixium Vision reimbursed the venture loan signed with Kreos Capital. Pixium Vision closed 2018 with a net cash position of €15.63 million compared with €10.53 million a year earlier.
Didier Laurens, CFO
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ABOUT PIXIUM VISION
Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Pixium Vision is in clinical stage with PRIMA, its sub-retinal miniature photovoltaic wireless implant system, designed for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners spanning across the prestigious Vision research institutions including Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA
The risk factors affecting the Company are presented in Chapter 4 of the Annual Report filed on March 26th, 2018 by the French Financial Markets Authority (AMF) under number D.18-0185.
To the best of the Company’s knowledge, the assessment of risks has not changed since the filing of its Annual Report.
The registration document is available on the company’s website:
During 2018, major developments include:
- On January 4, 2018, Pixium Vision received FDA approval to begin human clinical study of its PRIMA retinal implant in the US.
- On January 25, 2018, Pixium Vision completed world’s first activation in human of PRIMA bionic vision system.
- On February 8, 2018, Pixium Vision announced its 2017 annual results and provides business update.
- On March 13, 2018, Pixium Vision announced successful activations with PRIMA, its breakthrough Bionic Vision System, in the first three patients with atrophic dry-AMD.
- On April 11, 2018, Pixium Vision reported Q1 2018 cash position.
- On April 11, 2018, Pixium Vision launched a €10.6 million right issue to support the advances in clinical development of PRIMA, its breakthrough bionic vision system.
- On May 3, 2018, Pixium Vision announced the significant success of its €10.6 million right issue.
- On June 27, 2018, annual general meeting and board of directors of June 27, 2018.
- On July 10, 2018, Pixium Vision completed implantation of PRIMA in five patients with atrophic dry-amd as expected for the feasibility clinical trial in France.
- On July 26, 2018, Pixium Vision announced H1 2018 financial results and provided an update on its activities.
- On August 1, 2018, Pixium Vision restructured its bond financing facility with Kreos Capital.
- On August 30, 2018, Pixium Vision achieved successful activation of its photovoltaic PRIMA implant in all five study patients with dry age-related macular degeneration.
- On September 18, 2018, Pixium Vision announced the presentation of the first clinical results with PRIMA, its wireless implant, in patients with atrophic dry-AMD.
- On September 24, 2018, Pixium Vision announced positive review of the first results with PRIMA, its wireless subretinal implant, in patients with atrophic dry-AMD.
- On October 25, 2018, Pixium Vision reported cash position as of September 30, 2018.
- On October 30, 2018, Pixium Vision reported positive data with PRIMA, its wireless retinal implant, at the annual meeting of the American Academy of Ophthalmology.
- On December 13, 2018, Pixium Vision awarded Galien prize 2018 for research with prima system for dry-AMD.
- On December 24, 2018 - Pixium Vision established a new equity line financing with Kepler Cheuvreux.
After 31 December 2018 major developments were:
- On January 8, 2019, Pixium Vision announced its wireless PRIMA chip successfully met the interim study endpoints for dry age-related macular degeneration.
Comparison of 2018 and 2017 annual results
|(Amounts in euros)||As at 31st December|
|Research Tax Credit||1,322,986||2,057,327||2,057,327|
|Costs of goods sold||(41,172||)||(1,124,412||)||(1,253,929||)|
|Research and Development||(6,183,557||)||(7,817,392||)||(8,486,206||)|
|Sales and Marketing||(101,829||)||(530,718||)||(530,718||)|
|Adjusted operating income *||(7,526,136||)||(11,062,419||)||–|
|Financial profit / (loss)||(1,276,688||)||(875,776||)||(875,776||)|
|Current profit / (loss) before tax||(13,571,113||)||(13,541,934||)||(13,541,934||)|
|Other non-transferable comprehensive income|
|Actuarial gains / (losses) on pension plans||48,528||7,002||7,002|
|Total profit / (loss) for the half year||(13,522,585||)||(13,534,931||)||(13,534,931||)|
|Weighted average number of shares||18,523,505||13,267,646||13,267,646|
|Net earnings per share||(0.73||)||(1.02||)||(1.02||)|
|Diluted earnings per share||(0.73||)||(1.02||)||(1.02||)|
(*) Adjusted operating income: The operating income was adjusted for non-cash items related to charge for share-based compensation and loss of value registered in 2018.
In 2018, the Company generated no sales.
Other revenues amounted to respectively €1.60 million and €2.53 million, for the years ended 2018 and 2017. These amounts include the Research Tax Credit (CIR) reaching respectively €1.32 million and €2.11 million for the financial years 2018 and 2017. Pixium Vision has also booked in 2018 a product related to refundable advance from “Sight Again” project.
The French tax authorities grant research tax credits to businesses as an incentive to carry out technical and scientific research. Businesses with eligible expenditure (research carried out in France or, since 1 January 2005, within the European Community or any State party to the agreement on the European Economic Area having signed a tax treaty with France containing a mutual administrative assistance clause) benefit from a tax credit, which they may offset against corporation tax due for the financial year in which the expenses have been incurred and the three subsequent financial years. Where applicable, they may request reimbursement of any surplus tax credit amounts. Only research expenses are considered in the calculation of the research tax credit.
The Company has not capitalized R&D expenses in 2018 and 2017. Therefore, research tax credit amounts relating to its research programs have been recorded in full into operating income over the period.
Operating expenses amounted to €9.12 million and €13.60 million respectively for the years ended 2018 and 2017. In 2018, the operating expenses amount mainly correspond to Research and Development activities, which are recorded as expenses, as well as general and administration expenses. Following the halt in IRIS®II program, the "cost of goods sold" as well as “Marketing & Communication” were significantly reduced.
Research and development expenses
Research and development costs notably include:
·personnel costs, incorporating direct and indirect costs for teams involved in research and development activities;
·subcontracting, collaboration and consulting costs. These encompass the costs incurred for preclinical and clinical trials, patent filing and maintenance fees, fees payable to scientific and clinical experts and costs relating to regulatory and quality assurance matters;
·the purchase of research supplies, incorporating consumables and design and production costs;
·amortization and depreciation charges on the patents and equipment used in research and development projects.
Research and development costs break down as follow:
|R&D expenses (Amounts in euros)||31/12/2018||31/12/2017|
|Subcontractors, collaboration and consultants||1,531,793||2,833,885|
|Lease of real property||606,192||988,122|
|Conferences, travel expenses||109,374||157,184|
|Amortization, depreciation and provisions||381,334||291,603|
Research and development expenditure amounted to €6.18 million for the financial year 2018, compared to €7.82 million for the financial year 2017. This decrease is mainly due the drop of subcontractors involved in pre-clinical development of PRIMA as well as the end of IRIS®II clinical trial.
General & Administrative Expenses
G&A are mainly made up of administrative personnel costs, external costs such as legal, audit and consultancy fees and communication, hospitality, rental and travel costs.
The split of G&A costs is as follows:
|General and administrative (Amounts in euros)||31/12/2018||31/12/2017|
|Lease of real property||120,044||238,722|
|Communication, travel and entertainment expenses||390,583||581,534|
|Postal and telecommunication costs||50,632||60,057|
|Administrative supplies and equipment leases||22,634||32,933|
|Amortization, depreciation and provisions||561,811||567,441|
General and administrative expenses totalled €2.80 million and €4.13 in 2018 and 2017 respectively. The drop is due to the implementation of cost-saving plan in early 2018.
Marketing and Communication expenses
Marketing expenses are mainly made up of personnel costs, communication costs and travel costs. The split of “Marketing and Communication” costs is as follows:
|Selling and marketing (Amounts in euros)||31/12/2018||31/12/2017|
|Communication, travel and entertainment expenses||43,439||60,005|
Cost of goods sold
The Company incurred residual expenses in the manufacturing of the bionic vision system IRIS®II. As the Company recorded one sale of IRIS®II in 2017, the whole cost of goods sold was recognized in the P&L. These expenses are broken down as follows:
|Cost of goods sold (Amounts in euros)||31/12/2018||31/12/2017|
|Purchase of raw materials, supplies and other consumables||4,430||643,312|
|Subcontractors, collaboration and consultants||–||35,157|
|Change in inventory||36,742||(596,955||)|
|Amortization, depreciation and provisions||–||103,340|
Adjusted Operating income / loss
Adjusted Operating losses is reduced by 32% to €7.53 million in 2018 compared with a loss of €11.06 million in 2017.
Operating income / loss
The Company posted an operating loss of €12.29 million in 2018 versus an operating loss of €12.67 million in 2017. The operating result is negatively impacted by a non-recurring item of a €5.86 million impairment and exceptional amortization of IRIS® program. This charge is partially offset by a reversal of €1.09 million share-based payment.
Financial result amounted to a loss of €1.28 million in 2018. This loss is related to the interest payment of the venture loan signed with Kreos Capital in September 2016. Other financial expenses consist mainly of foreign exchange losses on dollars and British pounds’ purchases.
Financial income consists mainly of the remuneration of term deposits and other short to mid-term investments.
Having posted a loss, the Company did not record any corporate income tax.
Net profit/loss for the period and net earnings/losses per share
The Company posted net losses of €13.57 million and €13.54 million respectively for 2018 and 2017.
The loss per issued share amounted to (€0.73) and (€1.02) respectively in 2018 and 2017.
Cash Flow Statement
|(Amounts in euros)||As at 31st December|
|Cash flows from operating activities|
|Profit / (loss) for the half year||(13,571,113||)||(13,541,934||)|
|Reconciliation of net profit to cash flows used in operating activities|
|Depreciation, amortization and impairment||6,159,600||935,637|
|Loss of value on disposals||638,297||-|
|Non-cash charge for share-based compensation||(1,090,889||)||1,603,739|
|Retirement benefit obligations||33,492||3,545|
|Cash flows from operating activities||(7,634,385||)||(10,859,743||)|
|(Increase) / Decrease in trade receivables||–||30,060|
|Other current assets||708,719||(75,493||)|
|(Increase) / Decrease in trade payables||(238,463||)||(70,445||)|
|Other current liabilities||(346,023||)||91,921|
|Net cash flows from operating activities||(7,450,339||)||(11,480,655||)|
|Acquisitions of property, plant and equipment||(31,112||)||(191,404||)|
|Acquisitions of Intangible assets||–||–|
|Acquisitions of financial holdings||40,157||(210,873||)|
|Net cash flows from investing activities||9,045||(402,277||)|
|Increase / (Decrease) of refundable advances||879,000||–|
|Increase / (Decrease) of financial debt||(2,408,287||)||7,651,134|
|Share capital Increases||14,033,727||452,233|
|Net cash flows from financing activities||12,539,117||8,170,360|
|Opening cash and cash equivalents||10,531,602||14,244,174|
|Closing cash and cash equivalents||15,629,424||10,531,602|
|(Decrease) / Increase in cash position||5,097,822||(3,712,572||)|
Cash flows from operating activities
Cash flows used in operating activities amounted to €7.45 million and €11.48 million respectively in 2018 and 2017. The significant drop in cash consumption results in the success of the cost-reduction plan implemented as from beginning of 2018.
Cash flows from investing activities
Cash flows used in investing activities is not significant.
Cash flows from financing activities
Net cash flow from financing activities amounted to €12.54 million in 2018 to be compared to €8.17 million in 2017.
This increase is explained by the successful capital increase held in 2018 as well as the used of the Equity Line signed in October 2017 with Kepler Cheuvreux. In 2018, the Company also received €0.88 million as a refundable advance from the “Sight Again” R&D project. The cash-in has been partially offset by the repayment of €2.41 million of the venture loan signed with Kreos Venture.
|(Amounts in euros)||Note|
|Property, plant and equipment||5||706,107||1,567,341|
|Non-current financial assets||6||336,356||402,223|
|Total non-current assets||3,665,799||9,649,139|
|Stocks and work in progress||7||–||909,126|
|Other current assets||8||2,126,120||2,800,553|
|Cash & cash equivalents||9||15,629,424||10,531,602|
|Total current assets||17,755,544||14,241,281|
|Profit / (loss)||(13,571,113||)||(13,541,934||)|
|Total shareholders' equity||11,354,591||11,836,118|
|Total non-current liabilities||8,022,976||9,302,065|
|Trade account payables||15||983,951||1,222,414|
|Other current liabilities||16||1,016,110||1,345,633|
|Total current liabilities||2,043,776||2,752,237|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||21,421,343||23,890,420|
Total assets amounted to €21.42 million as at 31 December 2018 compared with €23.89 million a year earlier.
Net non-current assets stood at €3.67 million, and €9.65 million respectively at 31 December 2018 and 2017.
This includes non-current intangible, tangible and financial assets:
- Intangible assets amounted to €2.62 million and €7.68 million at 31 December 2018 and 2017 respectively mainly consisting of amortization of patents acquired from Intelligent Medical Implant. The decrease corresponds to the amortization of those acquired patents and the booking of an impairment on some of them.
- Tangible assets amounted to €0.71 million and €1.57 million at 31 December 2018 and 2017 respectively, are mainly made up of machinery and laboratory equipment. The drop is due to the accelerated amortization linked with the Company move is new premises.
- Non-current financial assets amounted to €0.34 million and €0.40 million as at 31 December 2018 and 2017. These assets are related to the security deposit paid to the landlord of the Company’s premises as well as deposit linked with the venture loan signed with Kreos Capital.
Net current assets amounted to €17.76 million and €14.24 million at 31 December 2018 and 2017 respectively.
Net current assets comprise:
- Other current assets:
|(Amounts in euros)||31/12/2018||31/12/2017|
|Deposits and advances||76,537||101,140|
|State, Research Tax Credit and CICE||1,323,485||2,133,406|
As at December 31st, 2018, other current assets consist mainly of the research tax credit receivable for €1.32 million and the increase in advances and prepayment related to R&D expenses incurred during the year. Prepaid expenses mainly correspond to expenses related to rents, insurance and travel expenses.
As at December 31st, 2018, the receivable related to the Research Tax Credit was lower than in 2017 since the Company booked a refundable advance of €0.88 million from “Sight Again” R&D project. Excluding this payment, the CIR asset would have been stable as compared with 2017 resulting in a stable R&D eligible expense.
- cash on hand, time deposits and transferable securities, breaking down as follows:
|(Amounts in euros)||31/12/2018||31/12/2017|
|Money market funds (SICAV)||–||–|
Shareholders’ equity stood at €11.35 million and €11.84 million respectively at 31 December 2018 and 2017:
- €85.01 million in share capital and issue premiums as at 31 December 2018 (€70.98 million as at 31 December 2017);
- Reserves, including previous losses of €60.09 million in 2018
- 2018 losses of €13.57 million.
Non-current liabilities are composed of venture loan, refundable advances and retirement benefit liabilities in accordance with IAS 19. Non-current liabilities increased in 2018 dropped following the reimbursement of the venture loan. Non-current liabilities amounted to €8.02 million (vs. €9.30 million in 2017) Refundable advances increased following the payment of the refundable advance received from “Sight Again”. Non-current provisions are composed of pension obligations.
This heading mainly incorporates operating liabilities, i.e.:
- Current provisions: €0.04 million as at 31 December 2018 represents the social charges incurred on free share plans.
- trade payables: €0.98 million as at 31 December 2018 (€1.22 million as at 31 December 2017);
- social security liabilities: €0.98 million as at 31 December 2018 (€1.29 million as at 31 December 2017);
- tax liabilities: €9,611 as at 31 December 2018 (€46,931 as at 31 December 2017);