Årsrapport Lars Terp 2016-05-05 Revisionspåtegning Regnskabsklasse B Beierholm Voergaardvej 2 9200 Aalborg SV 2015-01-01 2015-12-31 21002348 Zymenex Holding A/S Roskildevej 12 C 3400 Hillerød Hillerød 48 25 00 54 KPMG Amerika Plads 38 2100 København Ø Danmark Hillerød 2016-03-22 Paolo Patri CEO Jens Fogh Chairman Paolo Patri Claes Magnus Andersson Natallia Misuna Copenhagen 2016-03-22 KPMG Lau Bent Baun State Authorized Public Accountant 959931 152000 959930 151000 3596891 5383000 48145 725000 3548745 4657000 833955 879000 2714790 3778000 8900000 29774000 -6185210 -25996000 235358077 235358000 74525306 70470000 309883383 305828000 309883383 305828000 0 33827000 0 371000 0 34198000 3473847 380000 3473847 34578000 313357230 340406000 157000000 157000000 145761175 151946000 8900000 29774000 311661175 338720000 0 120000 833955 1482000 862100 84000 1696055 1686000 1696055 1686000 313357230 340406000 3593907 5329000 1 8000 2983 46000 0 715000 45564 5000 2581 5000 48145 725000 833955 879000 833955 879000 235358077 235358000 235358077 235358000 Zymenex A/S Hillerød 100 -64099563 656421 ACE Biosciences A/S Hillerød 100 3830037 414117 156922087 0 146771529 0 77913 0 0 0 31170982 0 0 -25996126 29774400 -31170982 31170982 157000000 0 151946385 29774400 -29774400 -6185210 8900000 157000000 0 145761175 8900000 Shares 157000000 1 Board of Directors and Executive Board have on this day considered and adopted the annual report for the financial year 01.01.15 - 31.12.15 for Zymenex Holding A/S. The annual report is presented in accordance with the Danish Financial Statements Act (Årsregnskabsloven). In our opinion, the financial statements give a true and fair view of the company’s assets, liabilities, financial position and results. We believe that the management’s review gives a true and fair review of the matters dealt with in the review. The annual report is submitted for adoption by the general meeting. To the shareholder of Zymenex Holding A/S We have audited the financial statements of Zymenex Holding A/S for the financial year 01.01.15 - 31.12.15, which comprise the income statement, balance sheet, accounting policies and notes. The financial statements are prepared in accordance with Danish Financial Statements Act. Management is responsible for the preparation of financial statements that give a true and fair view in accordance with the Danish Financial Statements Act. and for such internal control that Management determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error. Our responsibility is to express an opinion on the financial statements based on our audit. We conducted our audit in accordance with International Standards on Auditing and additional requirements under Danish audit regulation. This requires that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance as to financial statements are free from material misstatement. An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgement, including the assessment of the risks of material misstatements of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the company's preparation of financial statements that give a true and fair view in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company's internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by Management, as well as the overall presentation of the financial statements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Our audit has not resulted in any qualifications. In our opinion, the financial statements give a true and fair view of the company's assets, liabilities and financial position at 31.12.15 and of the results of the company's operations for the financial year 01.01.15 - 31.12.15 in accordance with the Danish Financial Statements Act. Pursuant to the Danish Financial Statements Act, we have read the Management’s review. We have not performed any further procedures in addition to the audit of the financial statements. On this basis, it is our opinion that the information provided in the Management’s review is consistent with the financial statements. Main activities Zymenex Holding A/S is a holding company for the Zymenex Group. The Zymenex Group consists of Zymenex Holding A/S, Zymenex A/S and ACE BioSciences A/S and three Swedish affiliates, Zymenex Holding A/S Danmark Filial Sverige, Zymenex A/S Danmark Filial Sverige and ECA-DK Bio, Filial av ACE BioSciences A/S, Danmark. As in previous years the main activity of the group has been the development of enzyme replacement therapy for the treatment of rare genetic diseases. Project status The Zymenex Groups pipeline has been focused on Lamazym (rhLAMAN) for the treatment of the lysosomale disease alpha-Mannosidosis. This disease is caused by a deficiency of the Laman enzyme and affects approximately 500 patients world-wide. The project is in late clinical development. The disease is life threatening and there is no treatment today. Previously Zymenex has been a partner in a number of European research groups under the EU grant "Euraman" for the development of the enzyme and has, together with this scientific group, published proof-of-principle data (Hum. Mol. Gen., vol.13, no.18, July 21, 2004). Zymenex and the research group concluded the EU grant "Hueman" under the 6th framework in October 2009 and has since October 2010, been working together with research groups and clinicians in an EU Framework 7 supported project group "ALPHA-MAN" with the continued development of Lamazym (rhLaman). In 2011 Phase 1 and Phase 2a clinical studies were conducted, and in 2012, Phase 2b was completed with positive results in both biochemical and clinical parameters. The project is now in Phase 3. Lamazym has Orphan Drug designation in both Europe and USA. The Zymenex Group also develops enzyme replacement therapy (ERT) for the lysosomal disease Globoid Cell Leukodystrophy (Krabbe Disease) and for Aspartylglucosaminuria (AGU disease). Both projects are in pre-clinical development. At the end of 2015, employees numbered 15, 8 of which work in the Zymenex A/S Swedish affiliate. Development in the company’s financial activities and affairs The income statement for the period 01.01.15 - 31.12.15 showed a profit of DKK 2,714,790 against DKK 3,778 thousand for the period 01.01.14 - 31.12.14. The balance sheet showed equity of DKK 311,661,175. Pharmaceutical development is in general an area with extensive risk. This includes delays in the development process, lack of effect of the product candidate in clinical trials or lack of approval from authorities in connection with production or marketing of the product candidate. Important events occurring after the end of the financial year No events materially affecting the financial position of the company have occurred after the end of the financial year. The company’s expected development Chiesi Farmaceutici S.p.A. that in August 2013 acquired Zymenex Holding A/S and its subsidiaries, has issued a letter of support stating that they will continue to provide financial support to enable Zymenex Holding A/S, Zymenex A/S and ACE Biosciences A/S to continue their development, trading and investments and to meet all their financial obligations as they fall due for payment for the foreseeable future and at least for the period until 31 December 2016. The annual report has been presented in accordance with the provisions of the Danish Financial Statements Act for reporting class B enterprises. The accounting policies have been applied consistently with previous years. In accordance with Section 110 of the Danish Financial Statements Act, the company has decided not to prepare consolidated financial statements. Income is recognised in the income statement as earned, including value adjustments of financial assets and liabilities. All expenses, including depreciation, amortisation, impairment losses and write-downs, are also recognised in the income statement. Assets are recognised in the balance sheet when it is probable that future economic benefits will flow to the company and the value of such assets can be measured reliably. Liabilities are recognised in the balance sheet when it is probable that future economic benefits will flow from the company and the value of such liabilities can be measured reliably. On initial recognition, assets and liabilities are measured at cost. Subsequently, assets and liabilities are measured as described for each item below. Certain financial assets and liabilities are measured at amortised cost applying a constant effective rate of interest over the term of the assets and liabilities. Amortised cost is determined as original cost less any principal repayments and less/plus accumulated amortisation of the difference between cost and nominal value. On recognition and measurement, account is taken of foreseeable losses and risks arising before the time at which the annual report is presented and proving or disproving matters arising on the balance sheet date. Gross profit comprises administrative expenses and other operating income. . Administrative expenses comprise expenses in connection with administrative employees, management, office premises, office expenses etc., including depreciation, amortisation and wages and salaries. Other operating income comprises items of a secondary nature in relation to the enterprise’s activities, including proceeds from the disposal of intangible assets and property, plant and equipment. Interest income and interest expenses, foreign currency translation adjustments as well as realised and unrealised capital gains and losses on securities are recognised under net financials. Amortisation of capital losses and loan costs relating to financial assets and liabilities is recognised on an ongoing basis as financial expenses and financial income, respectively. Dividend from equity investments recognised at cost is recognised as income in the parent in the financial year in which the dividend is declared. The current and deferred taxes for the year are recognised in the income statement as taxes for the year with the portion attributable to the net profit or loss for the year, and directly in equity with the portion attributable to amounts recognised directly in equity. The company is taxed jointly with the Danish consolidated enterprises. The parent is the administration company for the joint taxation and thus settles all income tax payments with the tax authorities. In connection with the settlement of joint taxation contributions, the current Danish income tax is allocated between the jointly taxed enterprises in proportion to their taxable incomes. This means that enterprises with a tax loss receive joint taxation contributions from enterprises which have been able to use this loss to reduce their own taxable profit. Investments in subsidiaries are measured in the balance sheet at cost less any impairment. Gains or losses on the divestment of subsidiaries are determined as the difference between the consideration and the carrying amount. Investments in subsidiaries are measured in the balance sheet at cost less any impairment. Gains or losses on the divestment of subsidiaries are determined as the difference between the consideration and the carrying amount. The carrying amount of non-current assets which are not measured at fair value is assessed annually for indications of impairment over and above what is reflected in depreciation/amortisation. If there are indications of impairment, an impairment test is conducted of individual assets or groups of assets. The assets or groups of assets are impaired to the lower of recoverable amount and carrying amount. The higher of net selling price and value in use is used as the recoverable amount. The value in use is determined as the present value of expected net cash flows from the use of the asset or group of assets as well as expected net cash flows from the sale of the asset or group of assets after the expiry of their useful lives. Receivables are measured at amortised cost, which usually corresponds to the nominal value, less write-downs for bad debts. Write-downs for bad debts are determined on the basis of an assessment of the individual receivables. Cash consist of bank deposits and cash at bank and in hand. The proposed dividend for the financial year is recognised as a special item under equity. As the administration company, the company assumes liability for the jointly taxed enterprises' income tax payments to the tax authorities in step with the joint taxation contributions being paid by the jointly taxed enterprises. Current tax payable and receivable is recognised in the balance sheet as tax computed on the basis of the taxable income for the year, adjusted for taxes paid on account. Joint taxation contributions payable and receivable are recognised as income tax in the balance sheet under receivables or payables. Deferred tax liabilities and deferred tax assets are computed on the basis of all temporary differences between the carrying amount and tax base of assets and liabilities. However, deferred tax is not recognised on temporary differences relating to goodwill which is non-amortisable for tax purposes and other items where temporary differences, except for acquisitions, have arisen at the date of acquisition without affecting either the net profit or loss for the year or the taxable income. In cases where the tax value can be determined according to different taxation rules, deferred tax is measured on the basis of the management's intended use of the asset or settlement of the liability. Deferred tax assets are recognised, following an assessment, at the expected realisable value through offsetting against deferred tax liabilities or tax on future earnings. Deferred tax is measured on the basis of the tax rules and at the tax rates which, according to the legislation in force at the balance sheet date, will be applicable when the deferred tax is expected to crystallise as current tax. Current liabilities are measured at amortised cost, which usually corresponds to the nominal value of the liability. The company is taxed jointly with the other danish companies in the group, and, as from the 2013 financial year, the company is liable together with the other jointly taxed companies for the total income tax and must comply with any obligations to withhold tax at source on interest, royalties and dividends for the jointly taxed companies. As at the balance sheet date, the total liability amounts to DKK 0. The liability furthermore includes any subsequent corrections to the calculated tax liability as a consequence of changes made to the jointly taxable income etc. Basis of influence Controlling influence: Chiesi Farmaceutici S.p.A. Parent company Zymenex Holding A/S is included in the consolidated financial statements of the parent, Chiesi Farmaceutici S.p.A. 21002348 2015-01-01 2015-12-31 21002348 2014-01-01 2014-12-31 21002348 2015-01-01 2015-12-31 e:ProposedDividendRecognisedInEquityMember 21002348 2014-01-01 2014-12-31 e:ProposedDividendRecognisedInEquityMember 21002348 2015-01-01 2015-12-31 e:RetainedEarningsMember 21002348 2014-01-01 2014-12-31 e:RetainedEarningsMember 21002348 2014-12-31 21002348 2015-12-31 21002348 2015-01-01 e:InvestmentsInGroupEnterprisesMember 21002348 2014-01-01 e:InvestmentsInGroupEnterprisesMember 21002348 2015-12-31 e:InvestmentsInGroupEnterprisesMember 21002348 2014-12-31 e:InvestmentsInGroupEnterprisesMember 21002348 2015-01-01 2015-12-31 1 21002348 2015-01-01 2015-12-31 2 21002348 2015-01-01 2015-12-31 3 21002348 2015-01-01 2015-12-31 4 21002348 2015-01-01 2015-12-31 1 21002348 2015-01-01 e:ContributedCapitalMember 21002348 2015-12-31 e:ContributedCapitalMember 21002348 2015-01-01 e:SharePremiumMember 21002348 2015-12-31 e:SharePremiumMember 21002348 2015-01-01 e:RetainedEarningsMember 21002348 2015-01-01 2015-12-31 e:RetainedEarningsMember 21002348 2015-12-31 e:RetainedEarningsMember 21002348 2015-01-01 e:ProposedDividendRecognisedInEquityMember 21002348 2015-01-01 2015-12-31 e:ProposedDividendRecognisedInEquityMember 21002348 2015-12-31 e:ProposedDividendRecognisedInEquityMember 21002348 2015-12-31 1 21002348 2015-01-01 2015-12-31 e:SubsidiaryMember 1 21002348 2015-12-31 e:SubsidiaryMember 1 21002348 2014-01-01 e:ContributedCapitalMember 21002348 2014-01-01 2014-12-31 e:ContributedCapitalMember 21002348 2014-01-01 e:SharePremiumMember 21002348 2014-01-01 2014-12-31 e:SharePremiumMember 21002348 2014-01-01 e:RetainedEarningsMember 21002348 2014-01-01 2014-12-31 e:RetainedEarningsMember 21002348 2014-01-01 e:ProposedDividendRecognisedInEquityMember 21002348 2014-01-01 2014-12-31 e:ProposedDividendRecognisedInEquityMember 21002348 2015-01-01 2015-12-31 e:SubsidiaryMember 2 21002348 2015-12-31 e:SubsidiaryMember 2 21002348 2015-01-01 2015-12-31 1 xbrli:shares xbrli:pure iso4217:DKK