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Recordati Industria Chimica e Farmaceutica

Annual Report Mar 4, 2019

4056_10-k_2019-03-04_4c150750-d3de-4dd0-8e22-3cd4e641cb5f.pdf

Annual Report

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PROPOSED ANNUAL REPORT AS AT AND FOR THE YEAR- ENDED 31ST DECEMBER 2018

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A.

Company subject to management and co-ordination by Rossini Luxembourg S.àr.l. Registered Office: 1 Via Matteo Civitali, Milan Fully paid up share capital: € 26,140,644.50 Tax identification number and Milan Company Registration No. 00748210150

The Company prepares the consolidated financial statements for the Recordati group

BOARD OF DIRECTORS

FLEMMING ØRNSKOV Chairman

ALFREDO ALTAVILLA Vice Chairman

ANDREA RECORDATI Chief Executive Officer

FRITZ SQUINDO GIAMPIERO MAZZA JAVIER DE JAIME GUIJARRO SØREN VESTERGAARD-POULSEN CATHRIN PETTY JOANNA SUSAN LE COUILLIARD Independent SILVIA CANDINI Independent MICHAELA CASTELLI Independent

BOARD OF STATUTORY AUDITORS

ANTONIO SANTI Chairman

MARCO ROBERTO NAVA LIVIA AMIDANI ALIBERTI Statutory Auditors

PATRIZIA PALEOLOGO ORIUNDI ANDREA BALELLI Alternate Auditors

Review of operations

To our Shareholders,

The Annual Report of the Company for the year ended 31st December 2018, which we submit to you for your approval, reports net income of € 217,330,294.

The review of operations in the consolidated annual report attached to this report may be consulted for information on operations and growth strategies.

The items in the reclassified income statement which shows costs by function are given below with the relative percentage of revenue(1) and the change compared with the previous year:

€ (thousands) 2018 % of
revenue
2017 % of
revenue
Change
2018/2017
%
Revenue (1) 448,842 100.0 371,131 100.0 77,711 20.9
Cost of sales (165,970) (37.0) (149,756) (40.3) (16,214) 10.8
Gross profit 282,872 63.0 221,375 59.7 61,497 27.8
Selling expenses (54,599) (12.2) (56,831) (15.3) 2,232 (3.9)
R&D expenses (41,216) (9.2) (30,167) (8.1) (11,049) 36.6
G&A expenses (33,418) (7.4) (30,304) (8.2) (3,114) 10.3
Other income (expense), net (1,464) (0.3) (2,611) (0.7) 1,147 (43.9)
Operating income 152,175 33.9 101,462 27.4 50,713 50.0
Dividends 135,162 30.1 160,050 43.1 (24,888) (15.6)
Write-down of investments (6,200) (1.4) 0 0 (6,200) n.s.
Financial (expense)/income, net (17,242) (3.8) (11,812) (3.2) (5,430) 46.0
Pretax income 263,895 58.8 249,700 67.3 14,195 5.7
Taxes (46,565) (10.4) (37,194) (10.0) (9,371) 25.2
Net income 217,330 48.4 212,506 57.3 4,824 2.3

(1) The revenue reported in the reclassified income statement includes other income of € 102 thousand (€ 123 thousand in 2017, relating in particular to training grants and rents, which in the statutory balance sheet are classified under Note 4 as Other revenue and income.

Revenue came to € 448.8 million, up € 77.7 million on 2017. Mention is made of the following in particular: the addition to the portfolio from July 2017 of products with a metoprolol base acquired from AstraZeneca (see the section entitled "Other Information" for a description of the acquisition of the rights for "metoprolol"; revenue from the products Transipeg®, Transipeglib®, Colopeg® (trademarks acquired from Bayer in December 2017 for the French market); the launch of Reagila® (cariprazine), a new pharmaceutical for the treatment of schizophrenia.

Good growth was recorded in Italy in sales of the following prescription products: Urorec® (silodosin), a specialty indicated for the treatment of the symptoms of benign prostatic hypertrophy (BPH); and Cardicor® (bisoprolol), a drug belonging to the beta blocker class indicated for the treatment of chronic cardiac insufficiency.

Sales of pharmaceutical chemicals, consisting of the active ingredients produced at the Campoverde di Aprilia plant, amounting to € 40.7 million, were more or less unchanged compared with 2017.

Selling expenses were down 3.9% compared with 2017 and they fell as a percentage of revenue to 12.2%.

R&D costs totalled € 41.2 million accounting for 9.2% of revenue.

General and administrative expenses were up € 3.1 million on 2017 due to the expansion of central management units needed for the integration, monitoring and co-ordination of foreign subsidiaries as the Group implemented its international growth strategy.

Operating income of € 152.2 million was up 50.0% on the year before amounting to 33.9% of revenue.

The write-down of investments, amounting to € 6.2 million, relates to the investment in the subsidiary Recordati Pharmaceuticals Ltd.

Net financial charges amounted to € 17.2 million, up € 5.4 million on the year before, partly as a result of interest due for "tax assessments by mutual agreement" paid in the last quarter.

Net income came to € 217.3 million, up € 4.8 million on the previous year.

A brief summary is given below of the net financial position, while further details are given in note 43 of the notes to the financial statements.

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Cash and cash equivalents and current receivables 140,040 274,111 (134,071)
Current debt (405,731) (337,091) (68,640)
Net current financial position (265,691) (62,980) (202,711)
Loans and receivables due after one year 3,107 10,105 (6,998)
Borrowings –
due after one year(1)
(693,100) (605,820) (87,280)
Net financial position (955,684) (658,695) (296,989)

(1) Including the recognition at fair value of derivative instruments to hedge foreign exchange rate risk (cash flow hedges).

The net financial position as at 31st December 2018 was a debt of € 955.7 million compared with debt of € 658.7 million as at 31st December 2017.

Dividends were distributed during the year totalling € 178.9 million, of which € 87.1 million for the balance on the 2017 dividend and € 91.8 million as an interim dividend relating to 2018 and treasury shares were purchased for a total amount of € 169.8 million. Furthermore, the company Natural Point S.r.l. was purchased in June for a net amount of approximately € 75 million and in December the company Tonipharm S.A.S. was purchased for around € 73 millio, while € 15 million was also paid in relation to the license agreement with Gedeon Richter for the Reagila® rights (cariprazine)."

Expenditure on property, plant and equipment came to € 12.1 million and related to investments made at the Milan headquarters (€ 5.2 million), which included investments in the plant and in pharmaceutical research, as well as in the Campoverde plant (€ 6.9 million).

R&D

In 2018 the Company's research and development activities were concentrated in the field of urology. The arrival of new pharmaceuticals both through internal research programmes and through opportunities to carry out research in collaboration with external research companies and institutions again represented a key factor in 2018 for enriching the pipeline and ensuring future growth for the Group. At the same time huge efforts were made on the regulatory front aimed at obtaining important authorisations to sell Recordati pharmaceuticals on markets in new geographical areas.

The main R&D activities carried out in 2018 are summarised in the paragraphs below.

Urology and Andrology

Research into urology

The company is focusing its research on the identification of new pharmaceuticals for the treatment of urination disorders, which affect the elderly above all, but which are also found in groups of patients affected by conditions often classified as rare, such as spina bifida.

REC 0/0438

Rec 0/0438 is a product for intravesical administration and it is used for patients with neurological hyperactive bladder, who must make daily recourse to self-catheterization to empty the bladder. The objective of this treatment is to reduce hyperactivity of the bladder and episodes of incontinence, which have a substantial impact on the quality of patients' lives.

Once single dose trials on healthy volunteers and on adult patients with post-traumatic lesions of the spine were completed, in 2018 a second programme of multicentre trials was launched at European level in patients with spinal lesions in order to assess the tolerability of repeated intravesical administrations of the pharmaceutical carried out directly by patients in the home. These trials also constitute a "Proof of Concept", because the effectiveness of the pharmaceutical in reducing hyperactive bladder of neurological origin is assessed by carrying out urodynamic tests in specialist neurological centres.

The first trial on cohorts of patients exposed to 1 mg was successfully completed during the year and the start of a second trial on cohorts (2 mg) was authorised by the Drug Safety Monitoring Committee with no manifestations of serious adverse reactions. If positive this trial will open up the way to the development of a pharmaceutical for paediatric spina bifida patients with secondary neurological hyperactive bladder.

Cardiology and metabolic diseases

Seloken® (metoprolol) and Logimax® (metoprolol + felodipine)

Regulatory activities were commenced in 2018 for the transfer to Recordati of authorisations for the sale in Europe of metoprolol and metoprolol + felodipine base AstraZeneca (AZ) products. These products are the result of original research by AZ. Their use is well-established and they strengthen Recordati's presence in the cardiovascular field.

Psychiatry

Reagila® (cariprazine)

Cariprazine is a new antipsychotic pharmaceutical authorised at European level for the treatment of schizophrenia, a mental disease characterised by serious behavioural disorders and disturbances of perception (hallucinations) and cognition (delirium). Delirium and hallucinations are also known as positive or productive symptoms and they are accompanied by negative symptoms such as apathy, with loss of affection and imagination, responsible for the loss of contact with reality by patients and their isolation

within a world that is incomprehensible to others. It is of particular interest here that during the clinical trials cariprazine was found to be effective in improving not only the positive symptoms in the adult population but also the negative symptoms.

As part of an agreement between Recordati and Gedeon Richter an initial pharmacokinetics clinical trial under the plan for paediatric development agreed at European was completed in 2018.

Other areas of treatment

LOMEXIN® (fenticonazol)

Fenticonazole is an antimycotic product for topical use, a product of Recordati research. An in vitro trial was completed in 2018 to test its antimycotic and antibacterial activities on strains of microorganisms isolated from patients. This data confirmed the importance of the pharmaceutical in the treatment not only of mycotic infections but also of mixed vaginal infections. The data is of particular interest because approximately 20-30% of women with bacterial vaginitis are also co-infected with Candida.

Furthermore, a review of the post marketing experience was completed in 2018 in order to assess the safety profile. A process was commenced on the basis of this analysis to update and standardise the literature for the product worldwide. Completion is expected in 2019.

OTHER INFORMATION

An important change took place in 2018 in the majority shareholdings of Recordati S.p.A. More specifically, on 29th June 2018 the members of the Recordati family, in their capacity as shareholders of Company's majority shareholder Fimei S.p.A., announced that they had reached an agreement to sell the entire share capital of Fimei S.p.A to a consortium of investment funds controlled by CVC Capital Partners VII Limited. On that date Fimei S.p.A. held 51.79% of the share capital of the Company. In order to implement that agreement, the sale to Rossini Investimenti S.p.A. (a company designated for that purpose on the basis of the aforementioned agreement) by the shareholders of Fimei S.p.A. of the entire investment held by them in Fimei S.p.A. was completed on 6th December 2018. As a result of that transfer, CVC Capital Partners VII Limited became the controlling shareholder of the Company within the meaning of Art. 2359, paragraph 1, No. 2) of the Italian Civil Code and Art. 93 of the Consolidated Finance Law, as results from a communication received in accordance with Art. 120 of Legislative Decree No. 58/1998.

Following these extraordinary operations involving the life of the Company in relation to the sale of their controlling interest by the Recordati family to a consortium of investment funds controlled by CVC Capital Partners VII Limited, on 28th February 2019 the Board of Directors of the company, appointed by a Shareholders' Meeting held on 5th February 2019, noted the management and co-ordination exercised by Rossini Luxembourg S.àr.l., over Recordati S.p.A. pursuant to articles 2497 and following of the Italian Civil Code. We report that Rossini Luxembourg S.àr.l. was formed on 14th May 2018 and the first financial statements of the company have not yet been approved.

Previously, although controlled by Fimei S.p.A, the Company did not consider itself subject to management and co-ordination by that company, pursuant to articles 2497 and following of the Italian Civil Code.

This was because Fimei S.p.A. was a mere financial holding company with no operations of any kind. No authorisation or reporting procedures existed in the Company in its relations with its parent and therefore the Company set its own strategic and operating policies completely independently.

The Board verified that the Company met the requirements pursuant to Art. 16, paragraph 1, letters b, c and d of the Markets Regulation approved by the Consob (Italian securities market authority) with Resolution No. 20249/2017. As concerns the disclosure obligations under Art. 2497-bis of the Italian Civil Code, pursuant to Art. 16, paragraph 1, letter a) of the aforementioned Regulation, these will be promptly satisfied within the legal time limits.

An agreement was concluded with AstraZeneca in June 2017 for the acquisition of the European marketing rights for the products Seloken®/Seloken® ZOK (metoprolol succinate) and the fixed combination Logimax®

(metoprolol succinate and felodipine). Metoprolol succinate is a beta-blocker indicated mainly for the treatment of various disorders including hypertension, angina pectoris and disturbances of cardiac rhythm and maintenance treatment following myocardiac infarct and functional cardiac disturbances with palpitations. It is a pharmaceutical that is widely used in many European countries which allowed Group companies to expand their product portfolios, especially in Poland, France and Germany.

The Company has considerable experience in marketing pharmaceuticals for cardiovascular diseases and has a large portfolio of pharmaceuticals for the treatment of hypertension and related disorders.

During the transition period, while waiting for the transfer of marketing authorisations in various countries, AstraZeneca has managed the distribution and sale of products on the market on behalf the Company on the basis of a transitional service agreement signed by both parties.

The impact of "metoprolol" on various items in the financial statements is described in the comments and in particular in the following notes to the income statement: No. 3 Revenue, No. 5 Costs for raw materials and goods, No. 7 Depreciation and amortisation and No. 8 Other operating expenses.

Treasury stock consisting of 1,476,000 shares was sold during the year, accounting for 0.71% of the share capital, for consideration of € 20.2 million, following the exercise of stock options as part of the 2010-2013 stock option plans by Group employees and 5,766,309 treasury shares were purchased accounting for 2.75% of the share capital, for consideration of € 169.8 million, at the service of the 2010-2013, 2014-2018 and 2018-2022 stock option plans.

As at 31st December 2018 the Company held 5,153,571 treasury shares with a face value of € 0.125 each accounting for 2.46% of the share capital.

The section "Principal risks and uncertainties" in the review of operations in the consolidated annual report attached to this report may be consulted for an analysis and description of the principal risks and uncertainties to which the Company is exposed pursuant to paragraphs 1 and 2 of article 2428 of the Italian Civil Code.

The information required under paragraph 3, point 6-bis of Art. 2428 of the Italian Civil Code concerning the Company's objectives and policies in respect of financial risk management is fully reported in the notes to the financial statements.

In compliance with the requirements contained in Art. 4, paragraph 7 of the Regulation on related-party transactions adopted with Consob Resolution 17221 of 12th March 2010 and subsequent amendments and also in Art. 2391-bis, paragraph 1 of the Italian Civil Code, the Company reports that it has adopted "Regulations for related-party transactions", the full text of which is available on the Company website at www.recordati.it (in the "Corporate Governance" section).

The Company has a secondary headquarters at 4 Via Mediana Cisterna, Campoverde di Aprilia (Latina).

Shares held by directors, statutory auditors, general managers and other key management personnel are reported in the Remuneration Report published in accordance with Art. 123-ter of the Consolidated Finance Law.

Reference is made to the information given in the Non-Financial Report for details of the principles governing conduct adopted by the Company.

RELATED-PARTY TRANSACTIONS

As at 31st December 2018, intercompany accounts with Group companies and the parent company Fimei S.p.A. showed payables of € 408,168 thousand and receivables of € 138,104 thousand. The most significant items were as follows:

  • receivables of € 9,964 thousand for loans granted to Group companies;
  • payables of € 84,924 thousand for loans received from Group companies;
  • trade receivables of € 53,777 thousand from subsidiaries;
  • trade payables to subsidiaries of € 8,392 thousand;
  • receivables from subsidiaries for the management of the centralised cash pooling treasury system amounting to € 74,339 thousand;
  • payables to subsidiaries for the management of the centralised cash pooling treasury system amounting to € 306,968 thousand;

Sales and services supplied to Group companies in 2018 amounted to € 223,223 thousand.

Dividends were received during the year as follows: € 45,000 thousand from Bouchara Recordati S.a.s., € 80,000 thousand from Recordati Ireland Ltd, € 5,438 thousand from Recordati Orphan Drugs, € 1,373 thousand from Recordati Pharmaceuticals Ltd and € 3,351 thousand from Herbacos Recordati S.r.o.

Tax payables include those to the parent company Fimei S.p.A. amounting to € 7,884 thousand, which relate to the following:

  • receivables for tax refunds requested relating to an application for an IRES (corporate income tax) tax refund because it had not made an expense based deduction from IRAP (regional tax on production) relating to personnel expense for employees for the years 2007 until 2011 in accordance with Art. 2, paragraph 1-quater of Decree Law 201 of 2011;
  • tax liabilities for current taxation relating to taxes for the year calculated on the basis of estimated taxable income. That liability was transferred by the Recordati S.p.A. to the parent company as a consequence of opting for tax consolidation in accordance with articles 117 to 128 of Presidential Decree 917/1986 as amended by Legislative Decree 344/2003.

The following summary is set out in the table below in compliance with Consob Resolution No. 15519 of 27th July 2006:

Percentage of transactions with related parties Related parties
€ (thousands) Total Amount %
Percentage of transactions or positions in the balance sheet
with related parties
Trade receivables and other 96,246 53,801 55.90
Long-term financial assets 3,107 3,000 96.56
Short-term financial assets 81,302 81,302 100.00
Trade payables and other 94,060 16,276 17.30
Long-term financial liabilities 694,819 61,135 8.80
Short-term financial liabilities 398,274 330,757 83.05

Percentage of transactions or positions in the income

statement with related parties
Revenue 450,741 223,296 49.54
Income from investments 135,162 135,162 100.00
Costs of purchases and service provision 201,100 27,010 13.43
Financial income/(expense), net (17,242) (1,915) 11.11

Transactions and positions with related parties as a percentage of cash flows is basically the same as that for the income statement items because the transactions are conducted under normal market conditions. It is underlined that no direct business was conducted during the year with the company that carries out management and co-ordination activities.

NON-EUROPEAN UNION SUBSIDIARIES

In relation to the provisions of articles 15 (former Art. 36) and 18 (former Art. 39) of the Markets Regulations (as amended by Consob Resolution No. 20249 of 28th December 2017) concerning the conditions for the listing of the parent companies of companies formed and regulated under the laws of countries that do not belong to the EU and which are of significant importance for the purposes of consolidated financial statements, since 31st December 2018 the regulatory provisions of Art. 15 (former Art. 36) of the Markets Regulations have applied to the subsidiaries the Recordati Ilaç, Recordati Rare Diseases Inc. And Rusfic LLC and the conditions laid down in the aforementioned Art. 15 (former Art. 36) in relation to which the certification is required from the management body, have been satisfied.

SIGNIFICANT TRANSACTIONS, EXCEPTION TO DISCLOSURE OBLIGATIONS

The Company decided to take advantage, with effect from 20th December 2012, of the right not to comply with obligations to publish the reports required when significant extraordinary operations are performed consisting of mergers, demergers, share capital increases through contributions in kind, acquisitions and disposals, in accordance with Art. 70, paragraph 8 and with Art. 71, paragraph 1-bis of the Issuers' Regulations issued by Consob with Resolution No. 11971/1999 and subsequent amendments.

BUSINESS OUTLOOK

The implementation of company policies, operations at the beginning of the current year, the potential of our products, the financial strength of the company and the managerial capacities of our personnel lead us to forecast a positive result again in 2019.

Milan, 28th February 2019

For the Board of Directors The Chief Executive Officer Andrea Recordati

INCOME STATEMENTS FOR THE YEARS ENDED 31ST DECEMBER 2018 AND 31ST DECEMBER 2017

Income statement

Amounts in euro Notes 2018 2017
Revenue 3 448,740,256 371,007,812
Other income: 4 2,000,889 2,033,524
Total income 450,741,145 373,041,336
Raw materials and goods costs 5 (119,270,855) (105,404,864)
Personnel costs 6 (80,716,836) (79,795,958)
Depreciation and amortisation 7 (22,080,464) (14,590,233)
Other operating expenses 8 (81,829,556) (78,225,666)
Changes in inventories 9 5,331,736 6,437,179
Operating income 152,175,170 101,461,794
Income from investments 10 135,162,189 160,050,000
Write-down of investments 11 (6,200,000) 0
Financial income (expense), net 12 (17,241,615) (11,812,244)
Pre-tax income 263,895,744 249,699,550
Taxes 13 (46,565,450) (37,193,806)
Net income for the year 217,330,294 212,505,744
Earnings per share (in euro)
Basic 1.063 1.026
Diluted 1.039 1.016

Basic earnings per share is calculated on average shares outstanding in the relative periods, consisting of 204,379,165 shares in 2018 and 207,030,319 in 2017. The figures are calculated net of average treasury stock held, which amounted to 4,745,991 shares in 2018 and 2,094,837 shares in 2017.

Diluted earnings per share is calculated taking into account stock options granted to employees.

BALANCE SHEETS as at 31ST DECEMBER 2018 and as at 31ST DECEMBER 2017

Assets
Amounts in euro Notes 31st December
2018
31st December
2017
Non-current assets
Property, plant and equipment 14 51,854,651 46,960,970
Intangible assets 15 242,173,970 239,514,582
Investments 16 928,900,151 774,357,367
Loans and receivables 17 3,106,777 10,104,582
Deferred tax assets 18 27,853,549 27,233,306
Total non-current assets 1,253,889,098 1,098,170,807
Current assets
Inventories 19 66,713,282 61,381,547
Trade receivables 20 89,393,672 82,250,366
Other receivables 21 6,851,845 8,556,027
Other current assets 22 927,018 652,671
Fair value of hedging derivatives (cash flow hedges) 23 6,414,332 3,824,811
Other short-term receivables 24 81,302,003 67,573,180
Short-term financial investments, cash and cash
equivalents 25 58,737,501 206,537,934

Total assets 1,564,228,751 1,528,947,343

BALANCE SHEETS as at 31ST DECEMBER 2018 and as at 31ST DECEMBER 2017

Equity and Liabilities

Amounts in euro Notes 31st December
2018
31st December
2017
Equity
Share capital 26 26,140,645 26,140,645
Additional paid-in capital 26 83,718,523 83,718,523
Treasury stock 26 (145,607,941) (17,029,155)
Statutory reserve 26 5,228,129 5,228,129
Other reserves 26 238,407,302 218,802,826
Revaluation reserve 26 2,602,229 2,602,229
Interim dividend 26 (91,760,954) (87,469,996)
Net income for the year 26 217,330,294 212,505,744
Total shareholders' equity 336,058,227 444,498,945
Non-current liabilities
Loans 27 694,819,367 602,712,138
Personnel leaving indemnities and other benefits 28 9,355,571 10,860,373
Other non-current liabilities 29 3,255,646 2,514,640
Total non-current liabilities 707,430,584 616,087,151
Current liabilities
Trade payables 30 49,372,645 55,763,611
Other current payables 31 25,155,139 20,992,064
Tax liabilities 32 19,532,019 8,416,591
Other current liabilities 33 1,622,727 0
Provisions 34 9,580,054 36,538,425
Fair value of hedging derivatives (cash flow hedges) 35 9,746,339 9,559,347
Loans –
due within one year
36 67,517,681 47,224,432
Bank overdrafts and short-term loans 37 7,457,274 2,384,170
Other short-term borrowings 38 330,756,062 287,482,607
Total current liabilities 520,739,940 468,361,247

Total equity and liabilities 1,564,228,751 1,528,947,343

STATEMENT OF COMPREHENSIVE INCOME FOR THE YEARS ENDED 31ST DECEMBER 2018 AND 31ST DECEMBER 2017

€ (thousands) 2018 2017
Net income for the year 217,330 212,506
Gains/(losses) on cash flow hedges (2,532) 1,553
Valuation of the personnel leaving indemnity fund pursuant to IAS 19 478 (74)
Adjustment to investments in listed companies 1,859 8,593
Income (expense) for the year recognised directly in equity (195) 10,072
Comprehensive income for the year 217,135 222,578
Data per share (in euro)
Basic 1.062 1.075
Diluted 1.038 1.064

STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY FOR THE YEAR ENDED 31ST DECEMBER 2018 AND 31ST DECEMBER 2017

€ (thousands) Share
capital
Additional
paid in
capital
Treasury
stock
Statutory
reserve
Other reserves Revaluatio
n reserves
Interim
dividend
Net
(loss)/Incom
e for the
period
Total
Sundry
reserves
Fair Value
hedging
instrumen
t reserve
IAS
compliance
reserve
Balance as at 31st December 2016 26,141 83,718 (76,761) 5,228 142,842 (7,419) 102,509 2,602 (72,245) 110,102 316,717
Allocation of 2016 net income
as per shareholder's resolution
of 11.04.2017
Dividends to shareholders
to Reserves (34,280) 72,245 (110,102) (37,857)
(34,280)
Merger gain 29,813 29,813
Sales of treasury stock 59,732 (29,465) 30,267
Dividends expired 5 5
Interim dividends (87,470) (87,470)
Total comprehensive income 1,553 8,519 212,506 222,578
IAS compliance as at 31st
December 2017
Stock options 3,961 3,961
Recordati Lux IAS reserve 765 765
Balance as at 31st December 2017 26,141 83,718 (17,029) 5,228 108,915 (5,866) 115,754 2,602 (87,470) 212,506 444,499
Effects of first time adoption of IFRS 15 (1,422) (1,422)
Balance as at 1st January 2018 26,141 83,718 (17,029) 5,228 107,493 (5,866) 115,754 2,602 (87,470) 212,506 443,077
Allocation of 2017 net income
as per shareholder's resolution
of 27.04.2018
Dividends to shareholders 87,470 (174,596) (87,126)
to Reserves 37,910 (37,910) 0
Sales of treasury stock 41,189 (20,972) 20,217
Repurchase of treasury stock (169,768) (169,768)
Dividends expired 5 5
Interim dividends (91,761) (91,761)
Total comprehensive income (2,532) 2,337 217,330 217,135
IAS compliance as at 31st
December 2018
Stock options 5,020 5,020
Acquisition 10% Opalia Pharma (741) (741)
Balance as at 31st December 2018 26,141 83,718 (145,608) 5,228 124,436 (8,398) 122,370 2,602 (91,761) 217,330 336,058

CASH FLOW STATEMENT FOR THE YEARS ENDED 31ST DECEMBER 2018 AND 31ST DECEMBER 2017

€ (thousands) 2018 2017
Operating activities
Net income for the year 217,330 212,506
Income from investments (135,162) (160,050)
Write-down of investments 6,200 0
Depreciation of property, plant and equipment 7,213 6,748
Amortisation of intangible assets 14,867 7,842
(Increase)/decrease in deferred tax liabilities 157 (26,349)
Increase/(decrease) in personnel leaving indemnities (1,505) (377)
Other provisions (26,958) 23,580
Dividends received 135,162 160,050
Trade receivables (7,143) (29,085)
Other receivables and other current assets 1,430 2,078
Inventories (5,332) (6,437)
Trade payables (6,391) 11,202
Other payables and other current liabilities 5,786 769
Tax liabilities 11,115 4,020
Net cash from operating activities 216,769 206,497
Investing activities
Net (investments)/disposals in property, plant and equipment (12,107) (8,858)
Net (investments)/disposals in intangible assets (17,526) (221,840)
Net (increase)/decrease in equity investments (156,233) (943)
Net (increase)/decrease in other non-current assets 6,998 6,292
Net cash used in investing activities (178,868) (225,349)
Financing activities
Loans – due after one year 153,591 389,518
Dividends distributed (178,887) (159,607)
(Purchase)/sale of treasury stock (149,551) 30,267
Effect on shareholders' equity of application of IAS/IFRS 1,451 1,934
Repayment of loans (46,924) (36,457)
Net cash from/(used in) financing activities (220,320) 225,655
Effects of extraordinary operation
Net (increase)/decrease in equity investments 0 (137,445)
Current assets and liabilities 0 445
Shareholders' equity 0 31,165
Net cash from/(used in) financing activities 0 (105,835)
Change in short-term financial position (182,419) 100,968
Short-term financial position at beginning of year * (15,755) (116,723)
Short-term financial position at end-of-year * (198,174) (15,755)

* Includes the total of other short term loans, short-term financial investments and cash and cash equivalents, bank overdrafts and other short-term borrowings excluding the current portion of medium and long-term loans.

RECORDATI S.p.A. NOTES TO THE SEPARATE COMPANY ANNUAL FINANCIAL STATEMENTS FOR THE YEAR ENDED 31ST DECEMBER 2018

1. GENERAL

The separate company annual financial statements comprise the income statement, the balance sheet, the statement of comprehensive income, the statement of changes in shareholders' equity, the cash flow statement and these notes to the financial statements.

The presentation adopted by the Company for the income statement in the separate company annual financial statements classifies revenues and expenses by nature. The distinction between the principle of current and non-current was adopted for the presentation of assets and liabilities in the balance sheet.

These financial statements are presented in euro (€) and all amounts in the notes to the statements are rounded to the nearest thousand euro unless otherwise stated.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

In compliance with Legislative Decree No. 38 of 28th February 2005 (which implements the options provided for by Art. 5 of Regulation (EC) No. 1606/2002 of the European Parliament and Council of 19th July 2002 concerning the application of international accounting standards) the separate company financial statements have been prepared by applying the international financial reporting standards (IFRS) issued or revised by the International Accounting Standards Board (IASB) and endorsed by the European Union and also the regulations issued in implementation of Art. 9 of Legislative Decree No. 38/2005.

These financial statements have been authorized for publication by the Board of Directors of the Company in their meeting of 28 February 2019.

Adoption of new standards

The Company has adopted two new accounting standards with effect from 1st January 2018:

  • IFRS 15, "Revenue from contracts with customers", which replaces IAS 18 "Revenue", IAS 11 "Construction Contracts" and the relative interpretations;
  • IFRS 9 "Financial Instruments", which replaces IAS 39 "Financial Instruments: Recognition and Measurement".

The standard IFRS 15, "Revenue from contracts with customers", introduces a single general model to establish if, when and in what amount revenue is to be recognised. In general, revenue is recognised according to IFRS 15 when the customer obtains control over goods or services and determination of the time at which control is transferred, at a determined point in time, or over time, requires an assessment by company management.

The main area of application for the Company regards accounting for up-front payments resulting from licence and distribution contracts. An analysis of existing contracts led to the conclusion that on the basis of the rules laid down by the new standard, the recognition of milestones recognised by customers as a result of these contracts must in some cases take place over the time of the duration of the agreements themselves.

The Company has applied IFRS 15 retrospectively with cumulative effect from the date of first time adoption. Therefore the information relating to 2017 has not been recalculated, which means that it has been presented according to the standards and interpretations in force at the date of the end of the preceding

financial year. Additionally, in general the disclosure obligations under IFRS 15 have not been applied to the comparative information.

The recalculation of up-front payments received in prior years, which according to the new standard must be recognised as revenue in 2018 and in subsequent years, resulted in a negative impact of € 1.4 million on equity as at 1st January 2018, against an increase in other liabilities amounting to € 2.0 million and an increase of € 0.6 million in deferred tax assets.

The accounting standard IFRS 9, "Financial instruments", introduces new requirements for the recognition and measurement of financial assets and liabilities and new rules for hedge accounting. The main area of application for the Company regards the calculation of write-downs on financial assets. IFRS 9 replaces the incurred loss model with a model based on forecasts of expected credit losses, which therefore takes account out of past events, current conditions and forecasts of future economic conditions. No significant impacts on equity as at 1st January 2018 were found on first time adoption of the new rules.

The new accounting standard IFRS 16 "Leases" will be applicable with effect from 1st January 2019. This eliminates the classification of leases as operating or finance for the purposes of the preparation of financial statements by companies that operate as lessees. Essentially, for all contracts with a lease term of longer than 12 months (unless the underlying asset has a low value), it will be necessary to recognise an asset representing the right-of-use, a liability representing the obligation to make payments in accordance with the contract and the effects in the income statement of the amortisation of the asset and recognition of the interest expenses on the financial liability. The Company intends to apply IFRS 16 from the date of first time adoption (i.e. 1st January 2019) using the modified retrospective method. Therefore, the cumulative effect of the adoption of IFRS 16 will be recognised as an adjustment to the opening balance for retained earnings as at 1st January 2019, with no recalculation of the comparative information. The impacts resulting from the application of the new standard are currently being assessed. On the basis of the currently available information, the Company envisages recognition of additional liabilities amounting between € 2 million and € 3 million as at the date of first time adoption. The effects on final figures resulting from the adoption of the aforementioned standard as at 1st January 2019 could be different because the Company has not yet completed verification and assessment of tests on new IT systems and the new measurement criteria could be subject to modifications up until the presentation of the first financial statements for the year which comprise the date of first time adoption.

Use of estimates

The preparation of financial statements requires estimates and assumptions to be made by Management based on the best possible assessments that have an impact on the values of revenue, expenses, assets and liabilities in the balance sheet and disclosure of contingent assets and liabilities as at the balance sheet date. If in the future those estimates and assumptions should differ from the actual circumstances, they shall be modified appropriately in accordance with the changes in the circumstances.

A brief description is given below of those items in the financial statements which more than others require greater discretion on the part of Directors in making estimates and for which a change in the conditions underlying the assumptions used could have a significant impact on financial data.

  • Investments in subsidiaries: according to the accounting standards applied, investments in subsidiaries are subject to an annual impairment test to ascertain whether a reduction in value has occurred. That test requires the use of discretionary assessments by directors based on the information available within the Group and on the market as well as on past experience. These assessments also depend on factors which may change over time, thereby influencing assessments and estimates made by Management. Furthermore, if it is found that potential impairment may have occurred, the Company proceeds to measure it by using the measurement techniques considered most appropriate.

  • Provisions: in some circumstances the decision as to whether or not a present obligation (legal or constructive) exists is not easy to make. Management assesses these circumstances on a case-bycase basis in combination with an estimate of the funds required to meet the obligation. When Management considers that it is only possible that a liability will arise, then the risks are reported in a special section of the report on commitments and risks without any recognition of a provision.

  • Deferred tax assets: recognition must be supported by a plan to recover these assets based on hypotheses and assumptions that Management considers reasonable.
  • Inventories: stock that may be obsolete or that has a slow turnover is periodically tested for impairment and is written down where the recoverable amount is less than the carrying amount. Write-downs are based on assumptions and estimates resulting from experience and historical results.
  • Financial instruments: trade receivables are adjusted by the relative allowances for bad debts to take account of their actual recoverable amount. Calculation of the amount of write-downs requires Management to make subjective assessments with account therefore taken of past events, current conditions and forecasts of future economic conditions.

Generally methods for measuring the fair value of financial instruments for accounting or disclosure purposes are summarised below with reference made to the main categories of financial instruments to which they apply:

  • derivative instruments: appropriate pricing models are used based on market values for interest rates;
  • loans and borrowings and unlisted financial assets: the discounted cash flow method (based on the present value of expected cash flows in consideration of current interest rates and credit ratings) is used for financial assets with maturities of greater than one year for measurement of the fair value on first time recognition. Subsequent recognition is carried out using the amortised cost method;
  • listed financial instruments: the market price as at the reporting date is used.

IFRS 13 requires the fair value of financial instruments to be measured by classifying them on the basis of a hierarchy of levels laid down by the standard itself, which reflects the degree of observability of the market inputs used in the calculation of the fair value. The following levels are identified:

  • Level 1: unadjusted quotations recorded on active markets for assets or liabilities subject to measurement;
  • Level 2: inputs that are not quoted prices as per level 1, but which are observable on the market, either directly (as in the case of prices) or indirectly (i.e. because they are derived from prices);
  • Level 3: inputs that are not based on observable market data.

Balance sheet

Property, plant and equipment - Property, plant and equipment is stated at historical cost less accumulated depreciation and any recognised impairment loss. Subsequent costs are only capitalised when it is probable that the future economic rewards will flow to the Company. The costs for ordinary maintenance and repairs are recognised through profit or loss at the time at which they are incurred.

The carrying amount of property, plant and equipment is subject to impairment testing to measure any loss in value when events or situations occur which indicate that the carrying amount of the assets can no longer be recovered (see paragraph on impairment).

Depreciation is calculated on a straight-line basis using rates which are held to be representative of the estimated useful life of the assets:

Industrial buildings 2.5%
-
5.5%
Plant & machinery 10% -
17.5%
Other equipment 12% -
40%

The depreciation of an asset begins when it is installed and is ready for use or, in the case of self-constructed assets, when the assets have been completed and are ready for use.

The gain or loss arising on the disposal or retirement of an asset is determined as the difference between the sales proceeds and the carrying amount of the asset and it is recognised through profit or loss for the year.

Intangible assets - An intangible asset is recognised only if it can be identified, if it is probable that it will generate future economic rewards and its cost can be measured reliably. Intangible assets are recognised at purchase cost, net of amortisation calculated on a straight-line basis and on the basis of their estimated useful life which, however, cannot exceed 20 years. Patents, licences and know-how are amortised from the year of the first sale of the relative products. Amortisation of distribution and licence rights is generally calculated over the duration of the contract.

Impairment - At each balance sheet date, the Company reviews the carrying amounts of its tangible and intangible assets to determine whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss. Where it is not possible to estimate the recoverable amount of an individual asset, the Company estimates the recoverable amount of the cash-generating unit to which the asset belongs.

The recoverable amount is the greater of net selling price and value in use. In measuring value in use, the estimated future cash flows are discounted to their present value using a pretax discount rate that reflects current market assessments of the time value of the money and the risks specific to the asset.

If the recoverable amount of an asset (or cash-generating unit) is estimated to be less than its carrying amount, the carrying amount of the asset (or cash-generating unit) is reduced to its recoverable amount. Impairment losses are recognized as an expense immediately.

Where an impairment loss subsequently reverses, the carrying amount of the asset (or cash-generating unit) is increased to the revised estimate of its recoverable amount, but so that the increased carrying amount does not exceed the carrying amount that would have been determined had no impairment loss been recognised. A reversal of an impairment loss is recognised as income immediately.

Investments in subsidiaries – Investments in subsidiaries are recognised at cost of purchase adjusted for impairment. Positive differences arising at the time of purchase between the purchase cost and the quota of the equity at present values held in the subsidiary attributable to the Company are therefore included in the carrying amount of the investment.

Investments in subsidiaries are subject to impairment testing annually or more frequently if necessary in order to test for possible loss of value. Where evidence exists that the value of these investments has been impaired, this is recognised through profit or loss as an impairment loss. Where an impairment loss subsequently reverses or reduces, this is recognised through profit or loss as a reversal of impairment within the limits of the cost of acquisition.

According to IFRS 2, stock option plans for the employees of subsidiaries constitute an increase in the value of the relative investments. That increase in value consists of the fair value of the options on the grant date and it is recognised as an increase in the investments at constant rates over the period between the grant and the vesting date, with the balancing entry recognised directly in equity.

Receivables (non-current assets) - Receivables are stated at their nominal value and reduced for impairment losses.

Inventories - Inventories are measured at the lower of cost or market value, where the market value of raw materials and subsidiaries is their replacement cost while that related to finished goods and work-in-process is their net realisable value.

Inventories of raw materials and supplies are measured at their average weighted purchase cost including costs incurred in bringing the inventories to their location and condition at year-end.

Inventories of work-in-process and finished goods are measured at their average weighted manufacturing cost which includes the cost of raw materials, consumables, direct labour and indirect costs of production, exclusive of general expenses.

Inventories are written-down if the market value is lower than cost as described above or in the case of obsolescence resulting from slow moving stocks.

Trade receivables - Trade receivables are stated at their nominal value as reduced by appropriate allowances for estimated irrecoverable amounts.

Cash and cash equivalents - Cash in banks on demand and highly liquid investments at fair value calculated by using their presumable realization value.

Equity - Equity instruments issued by the Company are recognised at the amount of the proceeds received. Dividends declared by the Company are recognised as a liability at the time of approval of the relevant resolution at the annual shareholders' meeting.

The cost and selling prices of treasury shares are recognised directly in equity and therefore gains and losses on sales are not recognised through profit or loss.

Loans - Interest-bearing loans are recognised at the amount of the proceeds received, net of direct issue costs.

Subsequently, loans are measured using the amortised cost method as required by IFRS 9. The amortised cost is the amount of the liability on initial recognition net of capital repayments and transaction costs amortised using the effective interest rate method.

If the loans are hedged using derivative instruments qualifying as "fair value hedges", in accordance with IFRS 9 these loans are measured at fair value as are their related derivative instruments.

Personnel leaving indemnities - Employee benefits stated in the balance sheet are the result of measurements carried out as required by IAS 19. The liabilities recognised in the balance sheet for postemployment benefit schemes represent the present value of the defined benefit obligation, as adjusted for unrecognised actuarial gains and losses and unrecognised past service cost. More specifically, the "Projected Unit Credit Method" is used. All actuarial gains and losses are shown directly in the statement of other comprehensive income recognised in equity. Until 31st December 2006 the personnel leaving indemnities of Italian companies were considered defined benefit plans. The regulations governing those indemnities were amended by Law 296 of 27th December 2006 (2007 Finance Act) and subsequent amendments made in early 2007. In view of those changes and more specifically for companies with at least 50 employees, those benefits are now to be treated as defined benefit plans only for the amounts that accrued prior to 1st January 2007 (and not yet paid at the balance sheet date), while subsequent to that date they are treated in the same way as a defined contribution plan.

Trade payables - These relate to payables arising from supply agreements and are recognised at their nominal value.

Other payables - These relate to payables arising in the normal course of business (to employees and third parties) and are recognised at their nominal value.

Bank overdrafts and loans - Bank overdrafts and loans are recognised on the basis of the amounts received, net of direct issue costs. Finance charges are accounted for on an accrual basis and are added to the carrying amount of the instrument to the extent that they are not settled in the period in which they arise.

Derivative instruments - The Company uses derivative instruments to hedge its risks associated with interest rate and foreign currency fluctuations. These derivatives are measured at fair value at the end of each reporting period.

Hedging relationships are of two types, "fair value hedge" or "cash flow hedge". A "fair value hedge" is a hedge of the exposure to changes in the fair value of an asset or liability that is already recognised in the balance sheet. A "cash flow hedge" is a hedge of the exposure to changes in cash flows relating to a recognised asset or liability or to a future transaction.

The gains and losses from the change in fair value of a derivative instrument qualifying as a "fair value hedge" are recognised immediately through profit or loss. All gains or losses resulting from movements in the fair value of the item hedged are also recognised through profit or loss.

The gains or losses from the change in fair value of a hedging instrument qualifying as a "cash flow hedge" are recognised directly in equity.

The gain or loss from the change in fair value of a derivative financial instrument which does not qualify as a hedging instrument is recognised immediately through profit or loss.

Provisions - Provisions are recognised when the Company has a present obligation as a result of past events, it is probable that an outflow of resources will be required to settle the obligation and a reliable estimate of the amount can be made.

Foreign currencies - Transactions in currencies other than the euro are initially recorded at the exchange rates prevailing on the dates of the transactions. Monetary assets and liabilities denominated in such currencies are retranslated at the rates prevailing on the balance sheet date. Profits and losses arising on exchange are recognised through profit or loss for the period. Non-monetary assets and liabilities, measured at historical cost in foreign currency are not translated on the balance sheet date.

Income statement

The expenses are stated on an aggregate basis in the income statement "by nature". The choice of this method of presentation is based on the nature of the Company as both a holding and an operating company. The objective is to both optimise and simplify general accounting practices and all the relative compliance activity required by Italian tax regulations.

Revenues - Revenues are recognised when it is probable that the economic rewards associated with a transaction will flow to the Company and that the amount of revenue can be measured reliably.

Revenue arising from the sale of goods is recognised when a customer obtains control of such goods. These are stated net of discounts, rebates and returns.

Revenues include income from royalties due on licensed out products and up-front payments received under licensing agreements.

Research and development expenses - All research costs are charged to the income statement in the year in which they are incurred in accordance with IAS 38. IAS 38 also requires development costs to be capitalised if technical and commercial feasibility of the asset for development or sale have been established. Regulatory and other uncertainties inherent in the development of new products are so high that the guidelines for capitalisation under IAS 38 are not met so that development costs are recognised through profit or loss in the year in which they are incurred.

Research and development costs include amounts due under collaboration agreements with third parties.

Non-reimbursable government grants - Government grants towards investment in plant are recognised as income over the periods necessary to match them with the related costs and are recognised in the balance sheet as deferred income. Non-reimbursable government grants, including those for research, are recognised through profit and loss on an accrual basis within the item "other revenue".

Share based payment transactions – According to IFRS 2, stock option plans for employees constitute a part of the remuneration of the beneficiaries, the cost of which is given by the fair value of the options on the grant date. It is recognised through profit or loss at constant rates over the period between the grant and the vesting date, with the balancing entry recognised directly in equity.

Financial items – These include interest income and expense, foreign exchange gains and losses, both realised and unrealised, and differences arising from the valuation of securities.

Taxation - Taxation for the year constitutes the sum of the tax currently payable and deferred tax.

The tax currently payable is based on taxable profit for the year and tax rates in force at the date of the balance sheet are applied.

Deferred tax is the tax expected to be payable or recoverable on temporary differences between the carrying amount of assets and liabilities in the financial statements and the corresponding tax basis used in the computation of taxable profit. Deferred tax liabilities are generally recognised for all taxable temporary differences and deferred tax assets are recognized to the extent that it is probable that taxable profits will be available against which deductible temporary differences can be utilized. Such assets and liabilities are not recognised if the temporary difference arises from goodwill.

Deferred tax is calculated at the tax rates that are expected to apply to the period when the liability is settled or the asset realised. Deferred tax is recognised directly through profit or loss, except when it relates to items recognised directly in equity, in which case the deferred tax is also recognised in equity.

Deferred tax assets and liabilities are offset when they relate to income taxes levied by the same taxation authority and the Company intends to settle its current tax assets and liabilities on a net basis.

Earnings per share - Earnings per share is the net income for the period attributable to ordinary shareholders divided by the weighted average number of ordinary shares outstanding during the period.

Diluted earnings per share is calculated by adjusting the average weighted number of outstanding shares for the effects of all the potential dilutive ordinary shares.

3. REVENUE

Revenue came to € 448,740 thousand in 2018 (€ 371,008 thousand in 2017) and was composed as follows:

€ (thousands) 2018 2017 Change
2018/2017
Net sales 423,315 359,041 64,274
Royalties and up-front payments 1,174 575 599
Revenue from services 24,251 11,392 12,859
Total revenue 448,740 371,008 77,732

Net sales revenue is as follows:

€ (thousands) 2018 2017
Italy Abroad Italy Abroad
Pharmaceuticals 191,715 189,642 185,242 132,065
Pharmaceutical chemicals 2,724 37,681 2,765 37,944
Others 242 1,311 389 636
Total revenue for net sales 194,681 228,634 188,396 170,645

Revenue from pharmaceuticals in Italy was € 191,715 thousand, up € 6,473 thousand on the previous year. Prescription pharmaceuticals saw growth in sales of Urorec® and Cardicor®.

Sales abroad in the pharmaceutical sector were up € 57.577 thousand compared with the previous year, attributable in particular to: sales of € 27.6 million for metoprolol based products made by the Company in the second half of 2017; sales of €7.1 million for Transipeg®, Transipeglib® and Colopeg® (trademarks acquired from Bayer for the French market in December 2017); sales of €7.6 million from the launch of Reagila®; and also to increased sales of lercanidipine in particular. The review of operations may be consulted for further information on products.

Net sales revenues included € 198,195 thousand (€ 126,327 thousand in 2017) for sales of products to subsidiaries:

€ (thousands) 2018 2017 Change 2018/2017
Recordati Ireland Ltd. 102,402 90,134 12,268
Innova Pharma S.p.A. 22,278 20,959 1,319
Laboratoires Bouchara Recordati S.a.s. 14,299 296 14,003
Casen Recordati S.L. 1,433 413 1,020
Jaba Recordati S.A. 2,792 2,674 118
Recordati Pharma GmbH 28,875 3,257 25,618
Recordati Ilaç 1,644 539 1,105
Orphan Europe S.a.r.l. 3,421 1,437 1,984
Opalia Pharma S.A. 15 21 (6)
Recordati Hellas Pharmaceuticals S.A. 1,065 1,259 (194)
Herbacos Recordati s.r.o. 7,793 4,220 3,573
Recordati Romania S.r.l. 3,300 1,118 2,182
Recordati Polska Sp. z o.o. 4,299 0 4,299
Recordati AG 4,165 0 4,165
Recordati BVBA 141 0 141
Recordati AB 92 0 92
Recordati Pharmaceuticals Ltd. 181 0 181
Total 198,195 126,327 71,868

All commercial transactions with subsidiaries took place under normal market conditions.

Revenues for royalties, up-front payments and services were composed as follows:

€ (thousands) 2018 2017 Change
2018/2017
Services and royalties to subsidiaries:
Orphan Europe Italy S.r.l. 40 40 0
Innova Pharma S.p.A. 823 883 (60)
Recordati Ireland Ltd. 14,239 2,125 12,114
Laboratoires Bouchara Recordati S.a.s. 700 765 (65)
Recordati Pharma GmbH 883 327 556
Casen Recordati S.L. 302 347 (45)
Jaba Recordati S.A. 271 315 (44)
Recordati Ilaç 293 359 (66)
Recordati Hellas Pharmaceuticals S.A. 95 96 (1)
Herbacos Recordati sro 103 19 84
Recordati Romania S.r.l. 76 6 70
Orphan Europe Sarl 1,624 1,238 386
Recordati Rare Diseases Inc. 1,838 1,457 381
Rusfic LLC 44 52 (8)
Recordati Polska Sp zoo 133 22 111
Italchimici S.p.A. 3,373 3,619 (246)
Natural Point S.r.l. 137 0 137
Recordati AG 47 0 47
Recordati BVBA 4 0 4
Recordati AB 1 0 1
Recordati Pharmaceuticals Ltd. 2 0 2
Total services and royalties to subsidiaries
25,028 11,670 13,358
Services and royalties to third parties
Royalties and up-front payments 397 297 100
Total services and royalties to third parties 397 297 100
Total revenue from services and royalties 25,425 11,967 13,458

The revenue from services to subsidiaries related principally to the "Group Service Agreement" for services performed on behalf of subsidiaries during the year.

Revenues from Recordati Ireland Ltd. included € 13,012 million for adjustments to intercompany transfer prices made on the basis of the same criteria defined by the tax authorities for prior years and incorporated in a "Commercial and Management Service Agreement".

Revenues from Orphan Europe Sarl and from Recordati Rare Diseases Inc. were attributable to R&D work carried out on behalf of those subsidiaries

Revenues from Italchimici S.p.A. related above all to the continuation of co-promotion carried out on behalf of the subsidiary as well as to a service contract.

Revenues from Laboratoires Bouchara Recordati S.a.s. included royalties amounting to € 256 thousand.

Services and royalties to third parties, which amounted to € 397 thousand, included € 350 thousand in relation to the adoption of the new accounting standard IFRS 15 for up-front payments resulting from licence and distribution contracts received in prior years.

4. OTHER REVENUE AND INCOME

Other revenue and income came to € 2,001 thousand in 2018, compared with € 2,034 thousand in 2017. It included charges to employees for the use of hired cars, other indemnities, non-recurring income, prior year income and gains on the sale of non-current assets.

We report that the gains included that on the sale of a non-business property located at Bari amounting to € 165 thousand.

There were also the charges passed on to licensees for the "1.83% discount" due on request from AIFA (Italian Medicines Agency) from the holder of the AIC (marketing authorisation).

Steps were taken during the year to recover the VAT incorporated in "pay back" payments made in prior years as permitted by a law dated 27th December 2017.

That recovery generated recognition of prior year income amounting to € 771 thousand.

A government grant towards current expenditure was received during the year amounting to € 17 thousand in relation to the conclusion of a project for the Campoverde headquarters.

Details of grants received for investments recognised in the income statement are given below for the last five years.

€ (thousands)
2014 14
2015 12
2016 6
2017 1
2018 0
Total 33

The item also included € 55 thousand of proceeds from property investments and € 18 thousand for charges made to the Parent company Fimei S.p.A. for service provision.

Income from property investments includes the rent of properties to the subsidiary Fimei S.p.A. amounting to € 8 thousand, the rent of premises at the Milan site to Innova Pharma S.p.A. amounting to € 12 thousand and the rent of part of the offices in via Marostica in Milan to Orphan Europe Italy S.r.l. for € 35 thousand.

5. RAW MATERIALS AND GOODS COSTS

These were composed as follows:

Total 119,271 105,405 13,866
Others and consumables 6,814 5,967 847
Packaging materials 7,500 7,553 (53)
Goods for resale 3,176 1,123 2,053
101,781 90,762 11,020
from other 70,759 52,284 18,475
from licensing-in agreements 31,022 38,478 (7,456)
Raw materials and goods:
€ (thousands) 2018 2017 Change
2018/2017

The change in purchases of raw materials, goods and other materials correlates with the changes in the sales mix for each product.

Other costs include purchases of metoprolol for € 13,439 thousand and those from Recordati Ireland Ltd for € 11,109 thousand, from Innova Pharma S.p.A. for € 6,404 thousand, from Casen Recordati S.L. for € 3,074 thousand and from Italchimici S.p.A. for € 702.

6. PERSONNEL COSTS

Personnel costs were composed as follows:

€ (thousands) 2018 2017 Change
2018/2017
Wages and salaries 56,302 55,926 376
Social security costs 17,790 17,542 248
Salary resulting from stock option plans 2,392 2,003 389
Other costs 4,233 4,325 (92)
Total personnel costs 80,717 79,796 921

The expense for stock option plans is a result of the application of IFRS 2, which requires the valuation of those options as a component of the wages of the beneficiaries and recognition of the cost determined in that manner in the income statement.

Other costs include the portions of the leaving indemnity charges for the year destined to pension funds in accordance with the legislation introduced by Law 296 of 27th December 2006.

Average workforce figures for the Company were as follows:

Total 1,027 1,008 19
Manual workers 378 371 7
Office workers 579 570 9
Executives 70 67 3
2018 2017 Change
2018/2017

7. DEPRECIATION AND AMORTISATION

This is composed as follows:

Amortisation of intangible assets

€ (thousands) 2018 2017 Change
2018/2017
Patent rights and marketing authorisations 10,066 5,074 4,992
Distribution, licence, trademark and similar
rights 4,801 2,768 2,033
Total 14,867 7,842 7,025

The increase in the amortisation of intangible assets compared with the previous year is attributable to the rights on metoprolol and on cariprazine.

Depreciation of property, plant and equipment

€ (thousands) 2018 2017 Change
2018/2017
Industrial buildings 1,232 1,137 95
General plant 552 513 39
Accelerated depreciation machinery 2,607 2,526 81
Normal depreciation machinery 1,314 1,189 125
Miscellaneous laboratory equipment 938 846 92
Office furnishings and machines 59 48 11
Electronic equipment 492 466 26
Vehicles for internal transport 20 23 (3)
Total 7,214 6,748 466

8. OTHER OPERATING EXPENSES

Other operating expenses were composed as follows:

€ (thousands) 2018 2017 Change
2018/2017
Pay back and discount of 1.83% 6,693 8,374 (1,681)
Meetings and scientific publications, market surveys and
expenses for medical and scientific communications and
advertising 9,923 9,609 314
Clinical and pharmacological trials and professional
advice 7,821 5,549 2,272
Commissions on sales paid to agents and logistics
commissions 5,832 6,165 (333)
Recordati Rare Diseases commissions 86 83 3
Transport and storage 2,306 2,266 40
Utilities and similar (motor fuel, gas, water, etc.) 5,209 4,458 751
Destruction of industrial waste and cleaning 1,939 1,842 97
Innova co-promotion service 2,117 1,976 141
Italchimici co-promotion service 289 262 27
Maintenance 3,822 3,923 (101)
Insurance premiums 645 673 (28)
Directors' fees 682 708 (26)
Statutory auditors' fees 127 124 3
Sundry personnel costs 3,298 3,290 8
Legal, judiciary and notary expenses 591 399 192
Sundry services and expenses charged back to
subsidiaries 5,902 5,823 79
Postal and telecommunications expenses 319 398 (79)
External processing 7,565 7,692 (127)
Laboratoires Bouchara external processing 216 291 (75)
Royalties payable 3,960 3,115 845
Recordati Ireland royalties payable 57 0 57
Rent of premises 352 340 12
Car hire expenses 2,370 2,426 (56)
Membership fees 258 210 48
Prior year expenses 69 67 2
Sundry taxation 1,780 1,780 0
Bad debt allowances 96 0 96
Provisions for sundry risks 295 0 295
Provisions for agent customer indemnities 149 133 16
Company and product acquisition costs 1,592 522 1,070
Service expenses and charges made by subsidiaries 2,956 1,458 1,498
Costs of the "Buzzi Hospital renovation" 0 2,000 (2,000)
IT system services 1,605 1,545 60
Other operating expenses 909 725 184
Total 81,830 78,226 3,604

The pay back cost of € 6,693 thousand, in addition to the 1.83%, discount also includes in particular a provision made to cover the risk of reductions in National Health Service spending on pharmaceuticals.

Expenses for sundry services included the auditors' fees.

Details of that remuneration are provided in attachment 6 in compliance with Art. 149-duodecies of the Consob Issuers' Regulations.

Sundry services included, amongst other things, R&D costs incurred on behalf of Orphan Europe Sarl and Recordati Rare Diseases Inc. and then charged back to subsidiaries and also service expenses relating to metoprolol incurred during the transition period.

Expenses for the Innova Pharma S.p.A. and Italchimici S.p.A. co-promotion service related to services carried out by the sales network of those companies on behalf of the Parent Company.

Details are given in the relevant parts of the Remuneration Report (published in accordance with Art. 123-ter of the Consolidated Finance Law) of the following: the remuneration of directors, statutory auditors, general managers and other key management personnel; the shares held in the Company by those persons; the stock option rights granted to them.

No use was made of finance lease assets in 2018.

The increase in royalties paid compared with 2017 relates directly to the sales of metoprolol and Reagila®.

The intercompany services included services received from the subsidiaries Herbacos Recordati s.r.o. (€ 977 thousand), Recordati A.G. (€ 184 thousand) and Recordati Polska Sp. z.o.o. (€ 1,795 thousand), mainly in relation to activities carried out by subsidiaries for metoprolol.

The item "sundry taxation" amounting to € 1,780 thousand (€ 1,780 thousand in 2017) relates to the following:

€ (thousands) 2018 2017 Change
2018/2017
Contribution under Decree Law No.
269/2003 172 242 (70)
Government licence tax 720 632 88
Municipal property and service taxes 311 313 (2)
Stamp duties and similar 16 15 1
Non-deductible taxes 59 81 (22)
Sundry taxes 502 497 5
Total 1,780 1,780 0

In compliance with Decree Law 269 of 30th September 2003 converted into Law 326 of 24th November 2003, a contribution was paid in April amounting to 5% of the expenses incurred in the previous year for advertising activities, self-certified by the Company within the legal time limits. Taxes for government licences were attributable to the maintenance of and changes to registrations for ethical and self-medication products and to the registrations of new products. Sundry taxes include Tari (refuse tax), convention and congress registration taxes and Campoverde duties.

9. CHANGES IN INVENTORIES

Details of changes in inventories are as follows:

€ (thousands) 2018 2017 Change
2018/2017
Raw materials, ancillary materials,
consumables and supplies (1,201) 4,138 (5,339)
Intermediates and work-in-process 481 2,304 (1,823)
Finished products and goods 6,052 (5) 6,057
Total 5,332 6,437 (1,105)

10. INCOME FROM INVESTMENTS

Income from investments came to € 135,162 thousand (€ 160,050 thousand in 2017) and related to subsidiaries.

This income consisted of dividends declared and distributed by Bouchara Recordati S.A.S. (€ 45,000 thousand), Recordati Ireland Ltd. (€ 80,000 thousand), Recordati Orphan Drug (€ 5,438 thousand), Recordati Pharmaceuticals Ltd. (€ 1,373 thousand) and Herbacos Recordati s.r.o. (€ 3,351 thousand).

11. WRITE-DOWN OF INVESTMENTS

The write-down of investments, amounting to € 6,200 thousand (€ 0 thousand in 2017) relates the investment in Recordati Pharmaceuticals Ltd., as commented in note n. 16.

12. FINANCIAL (EXPENSE)/INCOME, NET

Net financial (expense)/income showed net expense of € 17,242 thousand in 2018 (€ 11,812 thousand in 2017). The main items are summarised in the table below.

€ (thousands) 2018 2017 Change
2018/2017
Foreign exchange gains (losses) (139) (3,966) 3,827
Loss on the derecognition of investments 0 (47) 47
Interest income from subsidiaries 734 1,071 (337)
Interest expense payable to subsidiaries (2,648) (2,605) (43)
Interest expense on loans (2,207) (1,325) (882)
Interest expense on bond debt (5,332) (4,290) (1,042)
Net interest on short-term financial positions (6,649) 488 (7,137)
Bank charges (886) (1,014) 128
Interest cost in respect of defined benefit
plans (IAS 19)
(115) (124) 9
Total (17,242) (11,812) (5,430)

Net financial charges amounted to € 17.2 million, up € 5.4 million on the year before, partly as a result of interest due for "tax assessments by mutual agreement" paid in the last quarter relating to the financial years 2009 to 2015.

The balance on foreign exchange differences for transactions in foreign currency represented a loss of € 139 thousand in 2018 compared with a loss of € 3,966 thousand in 2017. More specifically, the loss for the year consisted of € 108 thousand on transactions concluded during the year and a loss of € 31 thousand resulting from the translation as at 31st December 2018 of assets and liabilities in foreign currency. Art. 2426, point 8-bis is therefore applicable to that income, by which, if a net gain arises from the foreign exchange translation performed at the end of the year, that amount is allocated to a special reserve that is not distributable until the gain is actually realised.

Interest income from subsidiaries is as follows:

€ (thousands) 2018 2017 Change
2018/2017
Italchimici S.p.A. 125 141 (16)
Recordati AG 0 2 (2)
Orphan Europe Sarl 0 45 (45)
Fic Médical S.a.r.l. 0 1 (1)
Recordati Polska Sp. z.o.o. 7 7 0
Casen Recordati S.L. 398 578 (180)
Rusfic LLC 9 112 (103)
Opalia Pharma S.A. 44 141 (97)
Recordati Rare Diseases SA de C.V. 10 7 3
Recordati Ireland Ltd. 82 16 66
Laboratoires Bouchara Recordati Sas 38 1 37
Recordati Romania S.r.l. 21 20 1
Total 734 1,071 (337)

Interest income related to loans granted to subsidiaries during the year (€ 480 thousand) and to the centralised cash pooling treasury system in operation at the Parent Company since 2007 on the basis of which monthly interest receivable and payable is recognised at market rates (€ 254 thousand).

Short-term loans were outstanding as at 31st December to Recordati Polska Sp. z.o.o. (PLN 1,500,000) and to Recordati Rare Diseases SA de C.V. (MXN 3,000,000), while a long-term loan was outstanding to Casen Recordati S.L. (€ 9,000 thousand).

Interest expense paid to subsidiaries was as follows:

€ (thousands) 2018 2017 Change
2018/2017
Casen Recordati S.L. 77 50 27
Laboratoires Bouchara Recordati Sas 9 14 (5)
Innova Pharma S.p.A. 51 44 7
Jaba Recordati S.A. 5 6 (1)
Recordati Ireland Ltd. 8 93 (85)
Orphan Europe
Spain S.L.
5 6 (1)
Orphan Europe Sarl 68 60 8
Recordati Pharma GmbH 60 32 28
Recordati Rare Diseases Inc. 2,082 2,055 27
Recordati AG 2 0 2
Recordati Hellas Pharmaceuticals S.A. 6 5 1
Orphan Europe Germany GmbH 11 6 5
Herbacos Recordati s.r.o. 0 1 (1)
Orphan Europe Italy S.r.l. 21 15 6
Orphan Europe Benelux BVBA 3 2 1
Bouchara Recordati s.a.s. 17 48 (31)
Recordati A.B. 2 2 0
Rusfic LLC 132 44 88
Orphan Europe Middle East FZ LLC 15 5 10
Recordati Pharmaceuticals Ltd. 0 54 (54)
Recordati Orphan Drugs 66 63 3
Natural Point S.r.l. 8 0 8
Total 2,648 2,605 43

Interest expense relates to loans granted by subsidiaries during the year (€ 2,108 thousand) and to the centralised cash pooling treasury system amounting to € 540 thousand.

As at 31st December short-term loans were outstanding from the company Orphan Europe Middle East FZ LLC for € 11,600 thousand, from Natural Point S.r.l. for € 10,300 thousand, from Recordati A.G. for CHF 2,000,000 and from Recordati Rare Diseases Japan for JPY 58,000,000, while a long-term loan was outstanding from Recordati Rare Diseases Inc. for USD 70,000,000.

13. TAXES

Taxes recognised in the income statement were composed as follows:

€ (thousands) 2018 2017 Change
2018/2017
Current taxation:
IRES (corporate income tax) 34,272 24,489 9,783
IRAP (regional tax on production) 7,421 4,248 3,173
Substitute tax for relief on goodwill 0 12,640 (12,640)
Provisions for risks resulting from tax
inspections
5,308 22,143 (16,835)
Prior year taxation 3,926 0 3,926
R&D tax credit (4,751) 0 (4,751)
Total current taxation 46,176 63,520 (17,344)
Deferred taxation:
Movement in deferred tax assets/liabilities, net (1,006) (25,287) 24,281
Use of prior years deferred tax assets/liabilities 1,395 (1,039) 2,434
Total deferred tax liabilities 389 (26,326) 26,715
Total 46,565 37,194 9,371

Provisions for taxes were made on the basis of estimated taxable income.

The provision for deferred tax (assets)/liabilities of € 1,006 thousand was composed as follows:

2018 2017
Temporary
differences
Tax Effect Temporary
differences
Tax Effect
DEFERRED TAX ASSETS
-
Relief on goodwill
0 0 (78,997) (22,198)
-
Puretech valuation
0 0 (7,992) (2,317)
-
Provisions
(3,464) (831) (2,246) (539)
-
Costs relating to future years
(728) (175) (756) (181)
-
Write-down of inventories
0 0 (216) (52)
TOTAL (4,192) (1,006) (90,207) (25,287)
DEFERRED TAX ASSETS/LIABILITIES,
NET (1,006) (25,287)

The reconciliation between the current tax rate for income tax levied on the Company and the actual tax rate incurred is as follows:

2018 2017
% %
Tax rate applicable for IRES (corporate income tax) 24 24
Dividends from subsidiaries (11.7) (14.6)
Write-down of
investments
0.6 0
Contributions to congresses 0.2 0.2
Tax rate applicable for IRES (corporate income tax) 13.1 9.6
IRAP (regional tax on production) 2.8 1.7
Provisions for risks resulting from tax inspections 2.0 8.9
R&D tax credit (1.8) 0
Relief on goodwill 0 (3.8)
Adjustment of deferred taxes on equity investments 0 (1.5)
Prior year taxes 1.5 0
Tax rate on pretax income 17.6 14.9

IRAP (regional tax on production) as a percentage of pre-tax profit was 2.8% because the tax is calculated on a different tax basis which includes interest and some extraordinary items.

Provisions for risks resulting from tax inspections amounted to around € 5 million and they related to risks resulting from inspections into two Group companies for the years 2016 and 2017.

14. PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment, net of accumulated depreciation, as at 31st December 2018 and 2017 amounted to €51,855 thousand and € 46,961 thousand respectively. Changes in this item are given below.

€ (thousands) Land and
buildings
Plant and
machinery
Other
fixtures
Construction
in progress
Total
property,
plant and
equipment
Cost of acquisition
Balance as at 31.12.17 39,476 160,806 37,042 6,425 243,749
Additions 197 2,293 831 8,814 12,135
Disposals (9) (11) (606) 0 (626)
Reclassifications 589 1,890 1,009 (3,496) (8)
Balance as at
31.12.18
40,253 164,978 38,276 11,743 255,250
Accumulated depreciation
Balance as at 31.12.17 30,046 135,287 31,455 0 196,788
Depreciation 1,232 4,473 1,508 0 7,213
Disposals (9) (11) (586) 0 (606)
Balance as at 31.12.18 31,269 139,749 32,377 0 203,395
Carrying amount
As at 31st December 2018 8,984 25,229 5,899 11,743 51,855
As at 31st December 2017 9,430 25,519 5,587 6,425 46,961

In 2018 additions amounted to € 12,135 thousand and related to investments of € 5,198 thousand in the Milan plant and headquarters and to work done on the Campoverde di Aprilia plant amounting to € 6,937 thousand.

Depreciation for the period amounted to € 7,213 thousand and was calculated on all depreciable assets using rates which are held to be representative of the estimated useful life of the assets.

15. INTANGIBLE ASSETS

Intangible assets, net of accumulated amortisation, as at 31st December 2018 and 2017 amounted to € 242,174 thousand and € 239.515 thousand respectively. Changes in this item are given below.

€ (thousands) Patent rights
and marketing
authorisations
Distribution,
licence,
trademark
and similar
rights
Other Assets under
construction
and advances
Total
intangible
assets
Cost of acquisition
Balance as at 31.12.17 212,280 42,237 13,234 41,465 309,216
Additions 0 8,771 0 8,748 17,519
Reclassifications 0 39,726 0 (39,718) 8
Balance as at 31.12.18 212,280 90,734 13,234 10,495 326,743
Accumulated amortisation
Balance as at 31.12.17 32,039 24,429 13,234 0 69,702
Amortisation 10,066 4,801 0 0 14,867
Balance as at 31.12.18 42,105 29,230 13,234 0 84,569
Carrying amount
As at 31st December 2018 170,175 61,504 0 10,495 242,174
As at 31st December 2017 180,242 17,808 0 41,465 239,515

The additions to intangible assets amounting to € 17,519 thousand related mainly to the acquisition of the rights on cariprazine from Gedeon Richter.

All intangible assets have a defined useful life and are amortised over a period not exceeding 20 years.

16. INVESTMENTS

Investments amounted to € 928,900 thousand as at 31st December 2018, up € 154,543 thousand compared with 2017, as reported in the table in Attachment 1. The percentage of ownership and the number of shares or quotas possessed are reported in Attachment 2.

A comparison between the carrying amount of investments in subsidiaries and their valuation using the equity method, in accordance with Art. 2426 of the Italian Civil Code, is reported in Attachment 3.

IAS 27 - Separate financial statements - requires recognition of investments in subsidiaries according to the cost method or, as an alternative, using the fair value in accordance with IFRS 9. Recordati S.p.A. has adopted the cost criterion and therefore, where there are indications that part or all of the cost cannot be recovered, the carrying amount must be reduced to the relative recoverable amount, in compliance with IAS 36 (Impairment of assets). Where that impairment subsequently reverses or reduces, the carrying amount is increased to the amount of the new estimate of the recoverable amount which, however, cannot exceed the original cost. For the calculation of reversals for investments in companies that are not listed and that is where no reliable market value (fair value

less costs of disposal) can be determined, the recoverable value is determined by calculating the value in use of the investments. The expected results forecast in the business plans of each investment were taken into consideration in the calculation of the value in use, increased by their "terminal value" appropriately adjusted to take account of risks and uncertainties intrinsic to the assumptions on which the plans were based. Those results and the "terminal value" were discounted to present values by applying the current cost of capital of the companies in compliance with the method recommended in IAS 36.

Furthermore, we report that, where possible, an impairment test was carried out at consolidated level on the Group as the unit both to verify the recoverability of the equity investments recognised in the separate financial statements of Recordati S.p.A. and also to verify the recoverability of the goodwill arising in the consolidated financial statements of the Recordati group. It is therefore considered that the impairment test carried out at consolidated level also provides indications concerning possible impairment at the level of the separate financial statements and therefore for the purposes of testing the carrying amounts of equity investments for impairment.

The table below reports the discount rates used for carrying out impairment tests for each of the investments subject to testing:

Investment Discount rate
Recordati Pharmaceuticals Ltd. 7.28%
Recordati Hellas Pharmaceuticals S.A. 11.74%
RRD Canada Inc. 6.45%
RRD S.A. DE C.V. 14.45%

Reference is made for the other rates used to the same section in the consolidated financial report.

Forecasts of operational cash flows for the specific period (2019-2021) used for the calculation were taken from the 2019 budget approved by the Board of Directors of the Company on 18th December 2018 and, for the years 2020 and 2021, from specific forecasts for the investments subject to impairment tests, approved by the Board of Directors on 28th February 2019.

The value in use, determined according to the procedures described for each of the investments, was examined and approved by the Board of Directors. For the subsidiary Recordati Pharmaceuticals Ltd., the comparison between the value in use of the investment and the carrying amount for the Company resulted in the need to write the value down to the limit of the value in use calculated, which was € 6.2 million.

According to IFRS 2, stock option plans for the employees of subsidiaries constitute an increase in the value of the relative investments. That increase in value consists of the fair value of the options on the grant date and it is recognised as an increase in the investments at constant rates over the period between the grant and the vesting date, with the balancing entry recognised directly in equity. The cost of the stock options granted to employees of foreign companies was recognised as an increase in the value of the relative investments amounting to € 2,629 thousand.

The value of the investments in other undertakings relates to that in the English Company PureTech Health plc, specialised in start-up companies dedicated to innovative therapies, medical devices and new research technologies. The shares of this company have been admitted for listing on the London stock market since 19th June 2015 and the total fair value as at 31st December 2018 of the 9,554,140 shares held was € 18.0 million. The value of the investment was consequently increased by €1.8 million, compared with 31st December 2017, with the balancing entry, net of tax, recognised in other comprehensive income (in equity) in line with the accounting treatment in previous years.

A detailed summary of both directly and indirectly controlled subsidiaries is given in Attachment 4 with the sales revenue and net income for each company.

All the investments reported regard share capital with voting rights.

The relative part of the consolidated report may be consulted for further information on investments.

17. LOANS AND RECEIVABLES (non-current)

Non-current loans and receivables as at 31st December 2018 amounted to € 3,107 thousand (€ 10,105 thousand as at 31st December 2017) and related almost entirely to the long-term loan granted to Casen Recordati S.L. (€ 3,000 thousand due in 2020). That the loan was granted under normal market conditions.

18. DEFERRED TAX ASSETS

These amounted to € 27,854 thousand as at 31st December 2018 (€ 27,233 thousand as at 31st December 2017), up € 621 thousand, of which € 550 thousand resulting from first time adoption of IFRS 15 on 1st January 2018.

The overall movements in deferred tax assets and those in the main types are shown in the following two tables:

Balance as at 31st December 27,854 27,233
Uses (1,735) (3,108)
Increases 1,806 26,619
Balance as at 1st January * 27,783 3,722
€ (thousands) 2018 2017

* An amount of € 550 thousand resulting from the first time adoption of the accounting standard IFRS 15 was classified in this balance as at 1st January 2018 (see note No. 2).

€ (thousands) Balance as at
31/12/2017
Balance as at
01/01/2018
Provision Use Balance as at
31/12/2018
Adoption of IFRS 15 0 550 0 (97) 453
Relief on goodwill 22,198 22,198 0 0 22,198
Valuation of derivatives
instruments 1,853 1,853 799 0 2,652
Provisions for risks 2,642 2,642 831 (1,024) 2,449
Write-down of inventories 106 106 0 (48) 58
Valuation of investment in
the former Lux (30) (30) 0 (23) (53)
Other 464 464 176 (543) 97
Total 27,233 27,783 1,806 (1,735) 27,854

19. INVENTORIES

Inventories as at 31st December 2018 and 2017 amounted to € 66,713 thousand and € 61,382 thousand respectively, as shown in the following table:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Raw materials, ancillary materials,
consumables and supplies 14,426 15,628 (1,202)
Intermediates and work-in-process 14,878 14,397 481
Finished products and goods 37,409 30,097 7,312
AstraZeneca metoprolol stock 0 1,260 (1,260)
Total 66,713 61,382 5,331

Inventories increased by € 5.3 million to meet future expected requirements.

20. TRADE RECEIVABLES

Trade receivables as at 31st December 2018 and 2017 amounted to € 89,394 thousand and € 82,250 thousand respectively, as shown below:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Trade receivables from subsidiaries 53,015 37,004 16,011
Trade receivables from others:
Italy 30,546 28,210 2,336
Abroad 7,006 18,145 (11,139)
90,567 83,359 7,208
less:
Allowance for doubtful accounts (1,173) (1,109) (64)
Total trade receivables 89,394 82,250 7,144

Exposure calculated on receivables from others stood at 62 days outstanding as at 31st December 2018, in line with a year earlier.

The adjustment of receivables in non-euro currencies resulted in the recognition of negative exchange rate differences of € 1 thousand. The receivables are recognised inclusive of those adjustments.

Trade receivables from Group companies arose from the supply of goods and services and are composed as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Innova Pharma S.p.A. 4,363 4,390 (27)
Recordati Ireland Ltd. 28,315 18,029 10,286
Laboratoires Bouchara Recordati S.a.s. 1,834 698 1,136
Jaba Recordati S.A. 832 1,069 (237)
Recordati Pharma GmbH 5,675 474 5,201
Casen Recordati S.L. 435 231 204
Recordati Ilaç 1,431 291 1,140
Orphan Europe Italy S.r.l. 23 23 0
Recordati Hellas Pharmaceuticals S.A 120 597 (477)
Herbacos Recordati S.A. 1,865 2,818 (953)
Orphan Europe Sarl 2,008 1,821 187
Recordati Romania S.r.l. 341 623 (282)
Recordati Polska S.p. z.o.o. 1,149 10 1,139
Recordati Rare Diseases Inc. 0 1,497 (1,497)
Opalia Pharma S.A. 11 263 (252)
Rusfic LLC 54 60 (6)
Italchimici S.p.A. 3,733 4,068 (335)
Bouchara Recordati S.a.s. 0 42 (42)
Recordati AG 652 0 652
Recordati BVBA 26 0 26
Natural Point S.r.l. 148 0 148
Total 53,015 37,004 16,011

The increase in trade receivables from Recordati Ireland Ltd. is attributable to a charge of € 13,012 thousand made on the basis of the "Commercial and Management Service Agreement" (see note 3 Revenue).

The significant increases in trade receivables from Laboratoires Bouchara S.a.s., Recordati Pharma GmbH, Recordati Ilaç, Recordati Polska S.p. z.o.o. and Recordati AG is related to a corresponding increase in sales. Other changes are attributable to the automated netting procedures for outstanding intercompany positions, by which intercompany items are automatically offset against each other each month and the relative balances settled.

Changes in the allowance for doubtful accounts are as follows:

€ (thousands) 2018 2017
Balance as at 1st January 1,109 1,193
Use for losses on receivables (32) (84)
Addition for the year 96 0
Balance as at 31st December 1,173 1,109

The allowance is considered appropriate in relation to potential risks of insolvency.

The composition of the principal receivables in foreign currency is as follows:

31.12.2018 31.12.2017
Currency
€(000)
Currency €(000)
Receivables in US\$ 2,898,904 2,532 15,513,165 13,072

21. OTHER RECEIVABLES

Other receivables amounted to € 6,852 thousand (€ 8,556 thousand as at 31st December 2017). The composition is given in the table below.

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Tax income 2,479 2,175 304
From parent companies 24 0 24
From subsidiaries 762 541 221
Advances to employees and agents 2,089 392 1,697
Others 1,498 5,448 (3,950)
Total other receivables 6,852 8,556 (1,704)

Tax receivables as at 31st December 2018 amounted to € 2,479 thousand (€ 2,175 thousand in 2017). They were composed as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Refund requested from tax authorities 43 43 0
VAT 2,350 1,823 527
Receivables for foreign VAT tax authorities 86 51 35
Tax receivables pursuant to Recordati S.A. 0 258 (258)
Total tax receivables 2,479 2,175 304

The VAT credit consisted of the balance for December 2018 and the VAT refund applied for on 18th October 2007 in relation to VAT on motor vehicles.

Receivables from subsidiaries stood at € 762 thousand (€ 541 thousand in 2017) and related to VAT transferred under Group procedures from the company Innova Pharma S.p.A. (€714 thousand) and to sundry receivables amounting to € 48 thousand from the company Italchimici S.p.A..

Advances to employees and agents as at 31st December 2018 and 2017 came to € 2,089 thousand and € 392 thousand respectively. They consisted of advances to employees, expense accounts for medical representatives and loans granted to employees who exercised stock option rights amounting to € 1,868 thousand for the purchase of 154,500 shares resulting from the options granted on 9th February 2011, 8th May 2012, 29th July 2014 and 13th April 2016.

Receivables from others as at 31st December 2018 amounted to € 1,498 thousand (€ 5,448 thousand as at 31st December 2017) and included advances to suppliers.

22. OTHER CURRENT ASSETS

Other current assets amounted to € 927 thousand (€ 652 thousand as at 31st December 2017) and related mainly to prepaid expenses. These were advance instalments on periodic services covering two financial years.

23. FAIR VALUE OF HEDGING DERIVATIVES (CASH FLOW HEDGES) (current assets)

These amounted to € 6,414 thousand (€ 3,825 thousand as at 31st December 2017).

The market value (fair value) as at 31st December 2018 of the currency swaps entered into by the Company to hedge a bond issued for \$ 75 million on 30th September 2014 totalled € 6,414 thousand. That value represents the potential benefit resulting from a lower value in euro of the future cash flows in United States dollars in terms of principal and interest, due to an appreciation of the foreign currency with respect to the time of finalising the loan and acquiring the hedge instruments. More specifically, the fair value of the derivative to hedge the \$ 50 million tranche of the loan granted by Mediobanca was positive by € 4,407 thousand, while that of the instrument to hedge the \$ 25 million tranche of the loan granted by Unicredit was positive by € 2,007 thousand.

24. OTHER SHORT-TERM RECEIVABLES

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Casen Recordati S.L. 6,011 6,018 (7)
Orphan Europe Sarl 0 27 (27)
Laboratoires Bouchara Recordati S.a.s. 9,461 0 9,461
FIC Médical S.a.s. 0 88 (88)
Recordati Ireland Ltd. 50,546 37,232 13,314
Recordati Polska sp. z.o.o. 351 362 (11)
Rusfic LLC 0 711 (711)
Opalia Pharma S.A. 0 343 (343)
Recordati Romania S.r.l. 0 655 (655)
Recordati Rare Diseases SA de C.V. 141 134 7
Italchimici S.p.A. 14,331 22,003 (7,672)
Recordati Rare Diseases Japan 461 0 461
Total 81,302 67,573 13,729

Other short-term receivables all consist of amounts due from subsidiaries as follows:

These receivables are attributable to a cash pooling treasury system in operation at the Parent Company and to loans granted to Casen Recordati S.L., Recordati Polska sp. z.o.o. and Recordati Rare Diseases SA de C.V.. Interest is paid on these receivables at market rates.

25. SHORT-TERM FINANCIAL INVESTMENTS, CASH AND CASH EQUIVALENTS

These are composed as shown in the following table.

Deposits in bank current accounts 57,924 205,760 2018/2017
(147,836)
Cash on hand
Proceeds from derivative instruments
2
812
3
775
(1)
37
Total 58,738 206,538 (147,800)

Cash and cash equivalents as at 31st December 2018, consisted of current accounts and short-term bank deposits.

26. SHAREHOLDERS' EQUITY

A summary of the changes in the shareholders' equity accounts is reported in the relative statement. Following the entry into force of Legislative Decree 6/2003, which amended the Italian Civil Code, the table contained in Attachment 5 was introduced, which gives the composition of reserves on the basis of availability for use and distribution.

Share capital - The share capital as at 31st December 2018 amounting to € 26,140,645, is fully paid up and consists of 209,125,156 ordinary shares with a par value of € 0.125 each. It remained unchanged in 2018.

As at 31st December 2018 there were three stock option plans were in place in favour certain Group employees: the 2010-2013 plan with options granted on 9th February 2011, 8th May 2012, 17th April 2013 and 30th October 2013, the 2014-2018 plan, with options granted on 29th July 2014 and 13th April 2016 and the 2018-2022 plan with options granted on 3rd August 2018. The exercise price of the options is the average of the Company's listed share price during the 30 days prior to the grant date. The options vest over a period of five years and options not exercised within the eighth year of the date of grant expire. Options cannot be exercised if the employee leaves the Company before they are vested.

outstanding
as at
31.12.2018
73,500
427,500
25,000
15,000
2,171,000
2,961,500
4,818,000
10,491,500

Details of stock options outstanding as at 31st December 2018 are given in the table below.

Additional paid-in capital

Additional paid-in capital as at 31st December 2018 amounted to € 83,718 thousand and was unchanged compared with 31st December 2017.

The adoption of international accounting standards resulted in the elimination of revaluation reserves amounting to € 68,644 thousand. The tax obligation on these (untaxed – taxation suspended) was transferred to the additional paid-in capital reserve.

Treasury stock

As at 31st December 2018 this amounted to € 145,608 thousand, consisting of 5,153,571 shares held in portfolio.

The net decrease during the year was € 128,579 thousand and was due to the sale of 1,476,000 shares for € 41,189 thousand and to the purchase of 5,766,309 shares for € 169,768 thousand for use in the 2010-2013, 2014-2018 and 2018-2022 stock option plans.

Statutory reserve

This amounted to € 5,228 thousand and was unchanged compared with 31st December 2017 because the limit set by Art. 2430 of the Italian Civil Code had been reached.

Other reserves

Other reserves totalled € 238,408 thousand. Details are as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Gain on merger 29,813 29,813 0
Extraordinary reserve 73,184 57,663 15,521
Reserve under Art. 13 Par. 6 of Legislative
Decree 124/1993
99 99 0
Extraordinary VAT concession reserve 517 517 0
Research and investment grants 17,191 17,191 0
Non-distributable reserve for investments in
southern Italy 3,632 3,632 0
International accounting standards reserve 122,370 115,754 6,616
Total 246,806 224,669 22,137
Fair value of derivative instruments (8,398) (5,866) (2,532)
Total other reserves 238,408 218,803 19,605

Gain on merger

This amounted to € 29,813 thousand (unchanged compared with 2017) and it relates to the merger gain generated in 2017 following the merger of the former subsidiary Recordati S.A. Chemical and Pharmaceutical Company into the Company.

Extraordinary reserve

This amounted as at 31st December 2018 and 31st December 2017 to € 73,184 thousand and € 57,663 thousand respectively. The reserve increased by a total of € 15,521 thousand as result of the following:

  • allocation of profit for the year amounting to € 37,910 thousand in accordance with a shareholders' resolution dated 18th April 2018;
  • the allocation of dividends not paid and expired amounting to € 5 thousand;
  • the difference between the amount paid by Group employees who exercised options as part of stock option plans and the carrying amount of the treasury stock recognised in the balance sheet amounting to € 20,972 thousand, which was charged as a decrease to the extraordinary reserve in accordance with international accounting standards;
  • a decrease of € 1,422 thousand following first time adoption of the accounting standard IFRS 15.
  • Reserve under Art. 13, paragraph 6 of Legislative Decree 124/1993 This amounted to € 99 thousand as at 31st December 2018 and remained unchanged compared with the previous year.
  • Extraordinary VAT concession reserve This reserve (Laws 675/1977, 526/1982, 130/1983 and 64/1986), amounting to € 517 thousand, relates to special VAT allowances on investments and is unchanged compared with the previous year.
  • Research and investment grants These amount to € 17,191 thousand and are unchanged compared with the previous year. The grants are subject to taxation if they are used for purposes other than to cover losses, which, however, is not planned by the Company. The assets corresponding to the grants

received from the Ministry of Industry and Commerce (formerly Asmez) have been mainly fully depreciated.

  • Non-distributable reserve for investments in southern Italy This amounted to € 3,632 thousand and is unchanged compared with the previous year.
  • International accounting standards reserve This amounted to € 122,370 thousand (€ 115,754 thousand as at 31st December 2017) and is composed as follows:
€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Reversal of fixed asset revaluations 40,479 40,479 0
Revaluation of investments 43,054 43,054 0
Inventories 463 463 0
Personnel leaving indemnities (276) (754) 478
Stock options 16,855 14,463 2,392
Adjustment to investments for stock options 11,319 8,691 2,628
Reserve to adjust entries for the merged 24 765 (741)
company
Financial instrument adjustment reserve 10,452 8,593 1,859
Total 122,370 115,754 6,616

Changes that occurred in the items in 2018 included the following:

o Personnel leaving indemnities

the valuation of the personnel leaving indemnities provision in accordance with IAS 19 generated a reserve as at 31st December 2018 amounting to € 276 thousand;

o Stock options

the amount of € 16,855 thousand relates to the personnel expense for stock options issued and granted after 7th November 2002 and not yet exercised, valued in accordance with IFRS 2. The amount of € 11,319 thousand relates to the cost for the stock options of employees of subsidiaries, the valuation of which, in agreement with IFRS 2, was recognised as an increase in the value of the investments in the companies in which those employees work;

o Reserve to adjust entries for the merged company

This reserve, amounting to € 24 thousand, originated in 2017 following the merger by acquisition of the former subsidiary Recordati S.A. Chemical and Pharmaceutical Company into the Company.

The balance on this item is the result of the following:

  • an increase in other non-current liabilities, with a consequent decrease in reserves in equity for a total of € 1,328 thousand, in order to take account of the option to purchase the remaining 10% interest held by minority shareholders of the subsidiary Opalia Pharma S.A.;
  • a decrease in interest payable to the merged company Recordati S.A. Chemical and Pharmaceutical Company, following the alignment of the intercompany balances between the two companies, with a consequent increase in equity reserves by € 1,352 thousand.

o Financial instrument adjustment reserve

This reserve, amounting to € 10,452 thousand, is a result almost entirely of the adjustment as at the value date, net of tax, of the value of the investment in PureTech Health p.l.c., recognised in 2017 following the merger by acquisition already mentioned of Recordati S.A. Chemical and Pharmaceutical Company.

Reserve for fair value movements in derivative instruments

In accordance with the provisions of IFRS 9, this reserve is comprised of the following: the balancing entry of the amounts for the assets resulting from measurement at market value of cross currency swaps of a cash flow nature, the balancing entry of the amount recognised through profit or loss to offset movements in the exchange rate at the end of the year relating to a hedged loan in foreign currency and the liabilities resulting from the measurement at the market value of interest rate swap transactions also of a cash flow hedge nature. The amount as at 31st December 2018, net of tax, was negative by € 8,398 thousand.

Revaluation reserve

This amounted to € 2,602 thousand (unchanged compared with 2017) and consisted of revaluation balances within the meaning of Law 413/1991.

Untaxed (suspended taxation) reserves as at 31st December 2018 amounted to € 87,826 thousand and consisted of € 15,964 thousand of reserves for grants received net of the taxed portion, € 517 thousand of the VAT concession reserve and € 99 thousand of the reserve formed pursuant to the law regulating pension funds and € 71,246 thousand of the revaluation reserves net of the substitute taxes. Revaluation reserves amounting to € 68,644 thousand were eliminated in compliance with international accounting standards and the non-taxability was transferred to the additional paid-in capital reserve. No deferred tax provisions were recognised in respect of those reserves, because, in accordance with IAS 12, these deferred tax provisions are recognised in the year in which the distribution is declared.

27. LOANS

The composition of medium to long-term loans as at 31st December 2018 and 2017 is shown below:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Bond subscribed in dollars by the investor Pricoa Capital Group
(Prudential)
65,502 62,536 2,966
Loan granted by Unicredit at a floating interest rate repayable
in semi-annual instalments by 2020
15,000 25,000 (10,000)
Loan granted by Ing Bank at a floating interest rate repayable
in semi-annual instalments by 2020
11,250 18,750 (7,500)
Loan granted by BNL at a floating interest rate repayable in
semi-annual instalments by 2018
0 12,500 (12,500)
Loan granted by Centrobanca (now UBI Banca) at a floating
interest rate repayable in semi-annual instalments by 2022
27,273 34,091 (6,818)
Loan granted by BNL at a floating interest rate repayable in
semi-annual instalments by 2020
25,000 25,000 0
Loan granted by Intesa Sanpaolo at a floating interest rate
repayable in semi-annual instalments by 2021
25,000 25,000 0
Loan granted by Recordati Rare Diseases at a fixed interest
rate repayable in semi-annual instalments by 2025
61,135 58,367 2,768
Bond subscribed in euro by the investor Pricoa Capital Group
(Prudential)
125,000 125,000 0
Loan granted by Mediobanca at a floating interest rate
repayable in annual instalments by 2024
64,500 75,000 (10,500)
Loan granted by UBI Banca at a floating interest rate repayable
in a single instalment in 2022
50,000 50,000 0
Loan granted by Unicredit at a floating interest rate repayable
in a single instalment by 2021
50,000 50,000 0
Loan granted by Intesa Sanpaolo at a floating interest rate
repayable in semi-annual instalments by 2025
75,000 75,000 0
Loan granted by Banca Passadore at a floating interest rate
repayable in annual instalments by 2022
15,000 15,000 0
Loan granted by Banca del Mezzogiorno - Mediocredito
Centrale at a fixed and floating interest rate repayable in semi
annual instalments by 2021.
4,279 0 4,279
Loan granted by Mediobanca at a floating interest rate
repayable in semi-annual instalments by 2023
150,000 0 150,000
Total amortised cost of loans 763,939 651,244 112,695
Portion due within one year (67,518) (47,224) (20,294)
Portion due after one year 694,421 604,020 (24,521)
Expenses relating to loans (1,602) (1,308) (294)
Total 694,819 602,712 (24,315)

As at 31st December 2018 medium to long-term loans, inclusive also of the current portions (see note 36), amounted to € 762,337 thousand. The net increase of € 112,401 thousand compared with 31st December 2017 was the result of new loans for € 153,591 thousand, repayment instalments for the period amounting to € 46,924 thousand and the effect of foreign currency translations (an increase of € 5,734 thousand).

The portions of the medium to long-term debt due after 31st December 2019 will be repaid, on the basis of the repayment schedules, in the following years:

€ (thousands)

2020 85,293
2021 135,834
2022 133,221
2023 74,285
2024 32,091
2025 and after 234,095
Total 694,819

On 30th September 2014 the Company subscribed a bond for a total of \$ 75 million, divided into two tranches: \$ 50 million at a fixed rate of 4.28% per annum, repayable semi-annually from 30th March 2022 and maturing on 30th September 2026; and \$ 25 million at a fixed rate of 4.51% per annum, repayable semi-annually from 30th March 2023 and maturing on 30th September 2029. The conversion of the debt at 31st December 2018 determined an increase in liabilities of € 2,966 thousand compared with 31st December 2017, due to an appreciation of the United States dollar against the consolidation accounting currency. The loan was hedged at the same time by two currency rate swap transactions, which involved transformation of the debt into a total of € 56.0 million, at a fixed interest rate of 2.895% per annum for the tranche maturing in 12 years and at a fixed interest rate of 3.15% per annum for that maturing in 15 years. The measurement of the hedging instruments at fair value as at 31st December 2018, was positive on aggregate by € 6,414 thousand and was recognised directly as an increase in equity and an increase in the asset item "Fair value of hedging derivatives – cash flow hedges" (see note 23). The bond loan is subject to covenants and failure to comply with them may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

In May 2015, the Company signed a loan agreement with Unicredit for € 50 million, granted net of fees and commissions of € 0.4 million. The main terms and conditions of the loan are a floating interest rate equal to the 6-month Euribor plus a spread of 80 basis points and a life of five years with semi-annual repayments of the principal from November 2015 and until May 2020. The remaining debt at as at 31st December 2018 was € 15 million. The loan is partially hedged by an interest rate swap (a cash flow hedge), with which a portion of the debt is transformed to a fixed interest rate of 1.734%. Measurement of the fair value of the derivative instrument as at 31st December 2018 for the hedge of € 12.5 million was negative by € 74 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35). The loan contract with UniCredit contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

In 2015 the Company renegotiated a loan agreement with ING Bank for € 30.0 million, originally signed by the Company on 8th January 2014 with a change made solely to the interest rate.

The new terms and conditions are for a floating interest rate equal to the six-month Euribor plus a spread of 85 basis points (compared with 190 basis points under the previous agreement), while the semi-annual repayments of the principal from July 2016 and until January 2020 remain unchanged. The remaining debt at as at 31st December 2018 was € 11 million. The loan was fully hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to a fixed interest rate of 1.913% after the renegotiation described above. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 150 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

The loan agreement with ING Bank contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 30th September 2013, the Company signed a loan agreement with Banca Nazionale del Lavoro for € 50.0 million, disbursed net of expenses and commissions of € 0.6 million. The main terms and conditions were a floating interest rate equal to the 6-month Euribor plus a spread (which, following a renegotiation between the parties, was reduced from 200 basis points to 70 basis points from 1st April 2015 and to 50 basis points from 29th March 2017) and a life of five years with semi-annual repayments of the principal by September 2018 commencing from March 2015. The loan had been fully extinguished as at 31st December 2018.

On 30th November 2010, the Company signed a loan contract with Centrobanca (now UBI Banca), for a three-year programme of investments in Research & Development. The loan, which Centrobanca (now UBI Banca) funded through a loan from the European Investment Bank, amounted to € 75.0 million of which € 30.0 million, net of expenses of € 0.3 million, was disbursed in 2010 and € 45.0 million in the first quarter of 2011. The main terms and conditions were a floating interest rate and a life of 12 years with repayment in semi-annual instalments of the principal from June 2012 and through December 2022. The remaining debt at as at 31st December 2018 was € 27 million. In June 2012 the loan was hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to an interest rate of 2.575%. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 971 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

The loan agreement with Centrobanca (now UBI Banca) contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated shareholders' equity must be less than 0.75;
  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;

• the ratio of EBITDA to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 23rd December 2016, the Company signed a loan agreement with Banca Nazionale del Lavoro for € 25.0 million, disbursed net of fees and commissions of € 0.1 million. The main terms and conditions were a floating interest rate equal to the 6-month Euribor plus a spread of 40 basis points and a life of four years, with semi-annual repayments of the principal by September 2020 commencing from March 2019. The loan was fully hedged at the same time with an interest rate swap (a cash flow hedge), which transformed the whole debt to a fixed interest rate of 0.41%. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 76 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

The loan agreement with Banca Nazionale del Lavoro contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 23rd December 2016, the Company signed a loan agreement with Intesa Sanpaolo for € 25.0 million, disbursed net of fees and commissions of € 0.1 million. The main terms and conditions are a floating interest rate equal to the 6-month Euribor plus a spread of 60 basis points and a life of five years, with semi-annual repayments of the principal by December 2021 commencing from June 2019.

The loan was fully hedged at the same time with an interest rate swap (a cash flow hedge), which transformed the whole debt to a fixed interest rate of 0.68%. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 100 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

The loan agreement with Intesa Sanpaolo contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 8th November 2016, the Company signed a loan agreement with the subsidiary Recordati Rare Diseases for a total loan of \$ 70.0 million, in order to centralise the cash generated by the subsidiary, divided into two tranches \$ 30 million at a fixed rate of 3.35% per annum, repayable in a single instalment due on 13th June 2023 and \$ 40 million at a fixed rate of 3.50% per annum, repayable in a single instalment due on 13th June 2025. The conversion of the debt at 31st December 2018 determined an increase in liabilities of € 2,768 thousand compared with 31st December 2017, due to an appreciation of the United States dollar against the consolidation accounting currency. The loan was fully hedged with two cross currency swap transactions, which involved transformation of the debt into a total of € 62.9 million, at a fixed interest rate of 1.56% per annum for the tranche maturing in seven years and at a fixed interest rate of 1.76% per annum for that maturing in nine years. The measurement of the fair value of the hedging instruments at 31st December 2018 gave an aggregate negative result of € 4,695 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

In May 2017, the Company issued a bond for a total of € 125,000 thousand, at a fixed rate of 2.07% per annum, repayable annually from 31st May 2025 and maturing on 31st May 2032. The bond loan is subject to covenants and failure to comply with them may result in the immediate call of the loan. The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 28th July 2017, the Company signed a loan agreement with Mediobanca for € 75.0 million. The main terms and conditions of the loan are a floating interest rate equal to the 6-month Euribor plus a spread of 95 basis points and a life of seven years with annual repayments of the principal commencing in July 2018 and continuing until July 2024. The remaining debt at as at 31st December 2018 was € 64.5 million. The loan was hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to an interest rate of 1.29%. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 703 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35). The loan agreement with Mediobanca contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 7th December 2017, the Company signed a loan agreement with UBI Banca for € 50.0 million, disbursed net of up-front fees and commissions of 0.10%. The main terms and conditions of the loan are a floating interest rate equal to the 6-month Euribor plus a spread of 50 basis points, with semi-annual repayments of the interest and repayment of the principal in a single instalment on 7th September 2022. The loan was hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to an interest rate of 0.714%. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 423 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35). The loan contract with UBI Banca contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 29th September 2017, the Company signed a loan agreement with Unicredit for € 50.0 million, disbursed net of up-front fees and commissions of 0.15%. The main terms and conditions of the loan are a floating interest rate equal to the 6-month Euribor plus a spread of 55 basis points, with semi-annual repayments of the interest and repayment of the principal in a single instalment on 29th September 2021. The loan was hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to an interest rate of 0.698%. The measurement of the fair value of the hedging instruments at 31st December 2018 gave an overall negative result of € 401 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

The loan contract with UniCredit contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 18th October 2017 the Company signed a loan agreement with Intesa Sanpaolo for € 75.0 million, disbursed net of fees and commissions of 0.30%. The main terms and conditions of the loan are a floating interest rate equal to the 6-month Euribor plus a spread of 95 basis points and a life of 8 years with semi-annual repayments of the principal by October 2025 commencing from June 2019. The loan was fully hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to a fixed interest rate of 1.305%. Measurement of the fair value of the derivative instrument as at 31st December 2018 was negative by € 516 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35).

The loan agreement with Intesa Sanpaolo contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

On 10th November 2017, the Company signed a loan agreement with Banca Passadore for € 15.0 million, disbursed net of expenses and commissions of 0.05%. The main terms and conditions of the loan are a floating interest rate equal to the 3-month Euribor plus a spread of 65 basis points and a life of 5 years with annual repayments of the principal from November 2020 and until November 2022.

The loan contract with UBI Passadore contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

In July 2018 the company received € 4.3 million from Banca del Mezzogiorno-Mediocredito Centrale to support investments in research, of which € 3.9 million at a subsidised fixed interest rate of 0.50% to be repaid in six semi-annual instalments from 30th June 2019 and by 31st December 2021 and € 0.4 million at a floating interest rate equal to the 6-month Euribor plus a spread of 220 basis points, to be repaid in two instalments on 30th June 2019 and by 31st December 2021.

On 28th November 2018, the Company signed a loan agreement with Mediobanca for € 150.0 million, disbursed net of up-front fees and commissions of 0.45%. The main terms and conditions of the loan are a floating interest rate equal to the 6-month Euribor plus a spread of 130 basis points and a life of five years with semi-annual repayments of the principal from November 2020 and until November 2023. The loan was hedged by an interest rate swap (a cash flow hedge), which transformed the whole debt to an interest rate of 1.619%. Measurement of the fair value of the derivative instrument as at 31st December

2018 was negative by € 1,637 thousand and this was recognised directly as a reduction in equity and an increase in the liability item "Fair value of hedging derivatives – cash flow hedges" (see note 35). The loan agreement with Mediobanca contains financial covenants which, if not complied with, may result in the immediate call of the loan.

The financial covenants are as follows:

  • the ratio of consolidated net debt to consolidated EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
  • the ratio of consolidated EBIT to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

Those conditions were amply fulfilled.

28. PERSONNEL LEAVING INDEMNITIES AND OTHER BENEFITS

The balance as at 31st December 2018 was € 9,356 thousand (€ 10,860 thousand as at 31st December 2017). Changes in the item were as follows:

€ (thousands) 2018 2017
Balance as at 1st January 10.860 11.237
Additions during the year 115 125
Use for the year (769) (547)
Change in fair value of the personnel leaving
indemnity fund (IAS 19) (850) 45
Balance as at 31st December 9.356 10.860

The valuation of the personnel leaving indemnity fund in accordance with IAS 19 generated a liability as at 31st December 2018 of € 9,356 thousand. The calculations made, which used actuarial parameters updated as at 31st December 2018, found a smaller liability and resulted in the recognition of an adjustment of € 850 thousand to the fund compared with the figure as at 31st December 2017 which was stated, net of tax, in the statement of comprehensive income recognised in equity, as required by the relative accounting standard.

29. OTHER NON-CURRENT LIABILITIES

The balance as at 31st December 2018 stood at € 3,256 thousand (€ 2,515 thousand as at 31st December 2017) and relates to the quota of long-term debt for the acquisition of the investment in Opalia Pharma S.A.

30. TRADE PAYABLES

Trade accounts payable, which are entirely of a business nature and include end-of-year provisions for invoices to be received, amounted as at 31st December 2018 and 2017 to € 49,373 thousand and € 55,764 thousand, respectively. Details are as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Suppliers, subsidiaries 8,274 7,544 730
Suppliers, Italy 17,348 17,504 (156)
Suppliers, Italy for
invoices to be received
7,810 10,355 (2,545)
Suppliers, abroad 8,984 8,802 182
Suppliers, abroad for invoices to be
received 6,957 11,559 (4,602)
Total trade payables 49,373 55,764 (6,391)

Details for subsidiaries are as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Recordati Rare Diseases Inc. 1,076 9 1,067
Laboratoires Bouchara Recordati S.a.s. 107 22 85
Innova Pharma S.p.A. 2,421 2,510 (89)
Italchimici S.p.A. 289 262 27
Recordati Ireland Ltd. 2,922 2,832 90
Casen Recordati S.L. 1,056 507 549
Recordati AG (formerly Pro Farma AG) 99 28 71
Herbacos Recordati S.r.o. 217 387 (170)
Recordati Polska Sp. Z.o.o. 0 457 (457)
Recordati Romania S.r.l. 0 530 (530)
Recordati Pharmaceuticals Ltd 52 0 52
Recordati Nordic 35 0 35
Total payables to subsidiaries 8,274 7,544 730

There were no concentrations of large debts to a single or a small number of suppliers.

The adjustment of trade payables in non-euro currencies resulted in the recognition of net positive exchange rate differences of € 138 thousand.

The largest trade payables in foreign currency were as follows:

31.12.2018 31.12.2017
Currency €(000) Currency €(000)
Payables in US\$ 2,806,309 2,583 3,853,821 3,374
Payables in GBP 79,303 101 68,026 88

31. OTHER CURRENT PAYABLES

Other current payables as at 31st December 2018 amounted to € 25,155 thousand (€ 20,992 thousand as at 31st December 2017). They were composed as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Payables to third parties for the acquisition of
Opalia Pharma S.A.
655 655 0
Employees 8,902 9,519 (617)
Social security 6,962 6,902 60
Commissions to agents 717 745 (28)
Payables to AIFA (Italian Medicines Agency) 4,247 1,213 3,034
Others 3,672 1,958 1,714
Total other borrowings and payables 25,155 20,992 4,163

Payables to third parties regard the short-term portion of the debt for the acquisition of the investment in Opalia Pharma S.A. held by the former subsidiary Recordati S.A. Chemical and Pharmaceutical Company, merged by acquisition into Recordati S.p.A. in 2017.

Amounts due to employees include amounts accrued and not paid, vacations not taken and bonuses for presence and for achieving objectives.

Social security payables not only include contribution expenses for those periods but also the amount due to pension institutes for December.

Amounts payable to agents include € 298 thousand in commissions for foreign agents.

Payables to AIFA (Italian Medicines Agency) relate in particular to the quota relating to 2018 for the renewal of the contract agreement signed with AIFA on 29th September 2015 (the "Urorec Agreement"), in addition to the amount due to cover the debt to Regional Governments on the basis of Law No. 122 of 30th July 2010.

Other payables include directors' fees as at 31st December 2018 (€ 482 thousand) and those for credit notes to be issued (€ 1,308 thousand). We also report € 118 thousand of payables to Orphan Europe Italy S.r.l. in relation to VAT transfers within the Group.

32. TAX LIABILITIES

Tax liabilities as at 31st December 2018 amounted to € 19,532 thousand (€ 8,417 thousand as at 31st December 2017).

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Liabilities payable to Fimei S.p.A. for IRES
(corporate income tax)
7,884 2,479 5,405
Liabilities for current taxation 8,328 1,121 7,207
Liabilities for split payment of VAT 634 2,509 (1,875)
Liabilities for employee withholding taxes 2,483 2,040 443
Liabilities for self-employed withholding taxes 202 267 (65)
Other tax liabilities 1 1 0
Total tax liabilities 19,532 8,417 11,115

The payables to the parent company FIMEI S.p.A. are composed as follows:

  • receivables for tax refunds requested relating to an application for an IRES (corporate income tax) tax refund because it had not made an expense based deduction from IRAP (regional tax on production) relating to personnel expense for employees for the years 2007 until 2011 in accordance with Art. 2, paragraph 1-quater of Decree Law 201 of 2011;
  • tax liabilities for current taxation relating to taxes for the year calculated on the basis of estimated taxable income. That liability was transferred by the Recordati S.p.A. to the parent company as a consequence of opting for tax consolidation in accordance with articles 117 to 128 of Presidential Decree 917/1986 as amended by Legislative Decree 344/2003.

Liabilities for current taxation consist of the provision made for taxes due, net of payments made on account.

In advance application of the interpretation IFRIC 23 the item includes the provision of around € 5 million, made as a result of a decision to apply the criteria used already by the tax authorities for determining "tax assessment by consent" relating to the periods 2009 to 2015 to the tax years 2016 and 2017, making them subject to determination in 2019.

33. OTHER CURRENT LIABILITIES

As at 1st January 2018, the date of first time adoption of the accounting standard IFRS 15, € 1,973 thousand was recognised for up-front payments resulting from licence and distribution contracts received in prior years, but relating to the subsequent periods. During the year € 350 thousand was recognised through profit or loss and as a consequence the liability amounted to € 1,623 thousand as at 31st December 2018.

34. PROVISIONS

These consist of tax and other provisions as reported in the table below.

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Tax 0 25,745 (25,745)
For agent customer indemnities 1,630 1,669 (39)
Other risks 7,950 9,124 (1,174)
Total other provisions 9,580 36,538 (26,958)

The decrease during the year is due mainly to the use of provisions for taxes recognised in the previous year.

Movements in other provisions consisted of uses of € 4,638 thousand and additions of € 3,464 thousand.

Uses related mainly to recognition in the accounts of the quota relating to the year of the debt for the renewal of the contract agreement signed with AIFA (Italian Medicines Agency) on 29th September 2015 (the "Urorec Agreement"), to the work carried out for the "Buzzi Project", to the conclusion of employment legal proceedings and to the payment of notice indemnities to employees. Additions to provisions related mainly to the provision to cover reductions in National Health Service spending on pharmaceuticals.

35. FAIR VALUE OF HEDGING DERIVATIVES (CASH FLOW HEDGES) (current assets)

The balance as at 31st December 2018 was € 9,746 thousand (€ 9,559 thousand as at 31st December 2017).

The fair value measurement as at 31st December 2018 of interest rate swaps to hedge medium to long-term loans gave rise to a € 5,051 thousand liability, which represents the foregone benefit of paying currently expected future floating interest rates instead of the agreed interest rates for the duration of the loans. The fair value measurement relates to interest rate swaps entered into by the Company to hedge interest rates on loans granted by Centrobanca (€ 971 thousand), Banca Nazionale del Lavoro (€ 76 thousand), ING Bank (€ 150 thousand), Unicredit (€ 475 thousand), Intesa Sanpaolo ( €616 thousand), Mediobanca (€ 2,340 thousand) and UBI Banca €423 thousand).

The market value (fair value) as at 31st December 2018 of two cross-currency swaps entered into to hedge currency risks on loans to the United States company Recordati Rare Diseases, for a total nominal value of \$ 70,0 million, was negative on aggregate by € 4,695 thousand and was recognised directly as a reduction in equity.

36. LOANS – DUE WITHIN ONE YEAR

The current portions of medium and long-term loans due within one year as at 31st December 2018 and 2017 were composed as follows:

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Loan granted for research by Centrobanca (now UBI Banca)
at a floating interest rate repayable in semi-annual
instalments by 2022. 6,818 6,818 0
Loan granted by BNL at a floating interest rate repayable in
semi-annual instalments by 2018
0 12,406 (12,406)
Loan granted by Unicredit at a floating interest rate
repayable in semi-annual instalments by 2020
9,905 10,000 (95)
Loan granted by Ing Bank at a floating interest rate repayable
in semi-annual instalments by 2020
7,470 7,500 (30)
Loan granted by Mediobanca at a floating interest rate
repayable in annual instalments by 2024
10,500 10,500 0
Loan granted by Intesa Sanpaolo at a floating interest rate
repayable in semi-annual instalments by 2025
19,048 0 19,048
Loan granted by BNL at a floating interest rate repayable in
semi-annual instalments by 2020
12,500 0 12,500
Loan granted by Banca del Mezzogiorno - Mediocredito
Centrale at a fixed and floating interest rate repayable in
semi-annual instalments by 2021. 1,277 0 1,277
Total 67,518 47,224 20,294

37. BANK OVERDRAFTS AND SHORT-TERM LOANS

Bank overdrafts and short-term loans as at 31st December 2018 and 2017 amounted to € 7,457 thousand and € 2,384 thousand, respectively.

€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017
Current account overdrafts 47 21 26
Expenses on derivative instruments 975 961 14
Interest on loans 506 505 1
Interest on bond debt 929 897 32
Very short-term lending 5,000 0 5,000
Total 7,457 2,384 5,073

38. OTHER SHORT-TERM PAYABLES

The balance on other short-term payables consisted entirely of amounts due to subsidiaries and amounted to € 330,756 thousand (€ 287,483 thousand as at 31st December 2017).

Total 330,756 287,483 43,273
Rusfic LLC 758 0 758
Recordati AG 1,777 0 1,777
Natural Point S.r.l. 10,304 0 10,304
Orphan Middle East FZ LLC 11,609 7,003 4,606
Jaba Recordati S.A. 4,575 6,699 (2,124)
Orphan Europe Switzerland GmbH 0 331 (331)
Orphan Europe Nordic A.B. 792 1,392 (600)
Bouchara Recordati Sas 6,418 23,093 (16,675)
Recordati Pharma
Gmbh
55,308 40,362 14,946
Recordati Hellas Pharmaceuticals S.A. 4,262 4,262 0
Orphan Europe Portugal LDA 0 304 (304)
Orphan Europe Benelux BVBA 2,373 1,472 901
FIC Médical S.a.r.l. 489 0 489
Recordati Ireland Ltd. 0 77 (77)
Orphan Europe Italy S.r.l. 18,592 14,096 4,496
Orphan Europe Spain S.L. 3,934 5,431 (1,497)
Recordati Orphan Drugs 49,196 48,428 768
Recordati Rare Diseases Inc. 101 94 7
Orphan Europe Sarl 56,666 42,103 14,563
Orphan Europe Germany GmbH 11,636 6,147 5,489
Casen Recordati S.L. 54,573 42,410 12,163
Laboratoires Bouchara Recordati S.a.s. 0 11,024 (11,024)
Innova Pharma S.p.A. 37,393 32,755 4,638
€ (thousands) 31.12.2018 31.12.2017 Change
2018/2017

The payables consist of € 306,967 thousand for the centralised cash pooling system and of € 23,789 thousand for loans from Orphan Middle East FZ LLC (€ 11,609 thousand), Natural Point S.r.l. (€ 10,304 thousand), Recordati AG (€ 1,777 thousand) and Recordati Rare Diseases (€ 99 thousand).

39. FAIR VALUE OF FINANCIAL INSTRUMENTS

As required by IFRS 7, a comparison of the carrying amounts as at 31st December 2018 and the fair values of financial assets and liabilities is given below.

€ (thousands) Carrying Fair
amount value
Financial assets
Other short-term receivables 81,302 81,302
Financial investments and cash and cash equivalents 61,738 61,804
Trade receivables 89,394 89,394
Other receivables 6,852 6,852
Fair value of hedging derivatives (cash flow hedges) 6,414 6,414
Financial liabilities
Loans
-
at fixed interest rates
124,888 126,884
-
at fixed rate hedged by cross currency swaps (CCS)
126,401 116,952
-
at floating rate hedged with
interest rate swaps (IRS)
511,048 511,048
Trade payables 49,373 49,373
Other payables 46,310 46,310
Fair value of hedging derivatives (cash flow hedges) 9,746 9,746
Bank overdrafts and short-term loans 7,457 7,457
Other short-term
borrowings
330,756 330,756

40. DISCLOSURE OF FINANCIAL RISKS

The company aims to achieve a balanced and prudent financial structure as a fundamental condition for financing internal and external growth, thereby reducing financing costs to a minimum, while maximising returns. Speculative investments in shares, funds or financial assets which might impair the value of companies is not permitted.

The only financial investments admissible are investments in risk free assets and/or funds issued by major financial institutions.

The Company monitors the financial risks to which it is exposed in order to take immediate mitigation action, when necessary, in compliance with the applicable legislation and regulations and it transacts only with banks with a strong credit rating.

On the basis of the above and considering that the related effects would not be significant, no sensitivity analysis has been carried out.

As required by IFRS 7, information is given below on the main financial risks to which the Company is exposed.

Liquidity risk

The liquidity risk to which the Company could be exposed is the inability to raise sufficient funds for its ongoing business and for the development of its industrial and commercial activities.

The two main factors which determine the Company's liquidity are, on the one hand, the resources generated or absorbed by operations and by investments, and on the other, the expiry and renewal terms of debt or the degree of liquidity of financial investments and market conditions.

The terms and conditions of the Company's loans and its financial assets are set out in notes 24, 26, 34 and 35 which address, respectively, short-term financial investments, cash and cash equivalents, medium to long-term loans and the current portions of medium to long-term loans and bank loans and overdrafts.

The Company believes that the funds and credit facilities currently available, in addition to those generated by operations and financing activities, are enough to satisfy investment needs, working capital requirements and the repayment of debts on their natural due dates.

Credit risk

The Company closely controls its credit exposure through the allocation of credit limits to each single customer and an internal reporting system. As at 31st December 2018, the credit exposure was not critical due to the large number of customers, their geographical distribution and the average amount of each account receivable. More specifically as at 31st December 2018 gross trade receivables, inclusive of those receivable from subsidiaries, totalled € 90,567 thousand and the relative allowance for doubtful accounts of € 1,173 thousand recognised is considered to be sufficient in relation to the risk of insolvencies.

Interest rate risk

The Company raises funds using debt and invests excess cash in money market funds and other financial instruments. The fluctuation of market interest rates influences the cost and returns of the debt and investment instruments therefore affecting the Company's net financial charges.

The Company's policy is to limit the risk arising from interest rate fluctuations by establishing fixed interest rate loans or floating interest rate loans. Any floating rate loans are promptly hedged by using derivative instruments (e.g. interest rate swaps – IRS), used solely for hedging and not speculative purposes.

This hedging policy allows the company to minimise the risk attaching to fluctuations in interest rates (as illustrated in note 26).

Foreign currency risk

The Company is exposed to foreign currency fluctuations which can affect its operating results.

In particular, the Company is exposed to foreign currency fluctuations on its international sales and financing denominated in currencies other than the euro.

The company also enters into forward contracts for the purchase and sale of currency in order to hedge amounts at risk. It does this for hedging purposes only and not for speculation.

41. SEGMENT INFORMATION

Reporting by business segment and geographical area, presented in compliance with IFRS 8 – Operating segments – has been performed according to the same accounting policies employed in the presentation of the consolidated financial statements of the Group where, following the acquisition of Orphan Europe, two main segments have been identified: the pharmaceuticals segment and the orphan pharmaceuticals segment, which relates to the whole of Orphan Europe. Consequently the only business segment that exists for Recordati S.p.A. is the pharmaceuticals segment. Furthermore, the pharmaceutical chemicals business is considered an integral part of the pharmaceuticals segment because from an organisational and strategic viewpoint it is involved principally in the production of the active ingredients required to produce pharmaceuticals.

The following table presents net revenues by geographic area:

€ (thousands) 2018 2017 Change
2018/2017
Europe 422,828 347,676 75,152
of which Italy 199,040 192,993 6,047
Australasia 10,419 8,934 1,485
The Americas 13,937 12,516 1,421
Africa 1,556 1,882 (326)
Total 448,740 371,008 77,732

42. LITIGATION AND CONTINGENT LIABILITIES

In December 2015 the Milan Tax Police Unit of the Guardia di Finanza (finance police) served notice that it was commencing a general inspection on indirect taxes for the tax years 2009 to 2014 directly into the Recordati Group companies located in Ireland and Luxembourg, these being Recordati Ireland Ltd. and Recordati S.A. Chemical & Pharmaceutical Company, respectively. The declared objective of these inspections was to assess the operating context of these foreign companies in order to verify whether these companies are in reality only formally located abroad, but in substance managed and administered from Italy. Furthermore, on 28 February 2017, the Guardia di Finanza extended its inspection to cover direct taxes for the tax year 2015. Once the fact-finding stage consisting of the acquisition of documents and analysis of that information was concluded, the Guardia di Finanza made its final report to Recordati Ireland Ltd. on 6th September 2017 of the grounds that led it to consider that the Irish company was liable to pay taxes in Italy on corporate income in the tax years considered, with the consequent determination of claimed taxes due in Italy amounting to € 109.4 million, and those already paid in Ireland, amounting to € 51.8 million. Similarly, on 6th September 2017 the Guardia di Finanza made its final report to Recordati S.A. Chemical and Pharmaceutical Company of the grounds that led it to consider that the Luxembourg company was liable to pay taxes in Italy on corporate income in the tax years considered, with the consequent determination of claimed taxes due in Italy amounting to € 7.2 million. Recordati Ireland Ltd. and Recordati S.p.A. (in its capacity as the survivor of the merger of Recordati S.A. Chemical and Pharmaceutical Company) filed defence documents against the claims made in the aforementioned reports. In 2018 the Regional Department for Lombardy of the tax authorities, with jurisdiction for Recordati S.p.A., reviewed the claims made in the aforementioned "record of findings" and carried out further investigations into the relations between Recordati S.p.A. and its Irish subsidiary in the tax years 2009 to 2015. Following those investigations, the tax authorities concluded (in confirmation of the validity of the Company's arguments) that in the tax years running from 2009 to 2015, the Irish company had not operated as an "offshore dummy company". Nevertheless, according to the tax

authorities, part of the profits earned in those years by the Irish subsidiary should be attributed to Recordati S.p.A., on the basis of an alleged "management support" provided by the Italian Parent to its Irish subsidiary. On that basis the tax authorities made a proposal of "tax assessment by mutual consent", for IRES (corporate income tax) and IRAP (regional tax on production) purposes, for the tax years running from 2009 to 2015, on the basis of which it demanded additional payment of taxes totalling € 21.0 million, in addition to € 4.9 million of interest and € 2.5 million of fines to which, in view of the reduced penalties, Recordati S.p.A. agreed. The Company intention is to apply the same criteria for the subsequent tax years, 2016 to 2017, making them subject to determination in 2019, for which a provision of around € 5 million has been recognised in the income statement. The same criteria agreed with the Italian Revenue Agency for the preceding years and included in a Commercial and Management Service Agreement have been applied to 2018. Following a "record of findings" prepared by the Guardia di Finanza for the tax years running from 2009 to 2015 with regard to Recordati S.A. Chemical & Pharmaceutical Company, a company which was wound up and removed from the Luxembourg Register of Commerce on 21st June 2017 as a consequence of its merger into the Company, the Milan Provincial Department II (Audit Office) of the tax authorities made a proposal for "tax assessment by mutual consent" for the aforementioned tax years, with a demand made for taxes totalling € 4.6 million, in addition to € 1.1 million of interest and € 1.9 million of fines. As a consequence of the substantial reduction in the taxable amounts originally claimed and in view of the reduced penalties, the Company agreed to that proposal. The amounts involved in that agreement were almost entirely attributable to taxes on dividends received by the Luxembourg company, which it had always distributed fully to its parent company. As such they were already subject to taxation in Italy.

43. NET FINANCIAL POSITION

The following summary is set out in the table below in compliance with Consob Resolution No. 15519 of 27th July 2006:

€ (thousands) 31.12.2018 31.12.2017 Change
2017/2016
Deposits in bank current accounts and cash on
hand
58,738 206,538 (147,800)
Short-term loans to Group companies 81,302 67,573 13,729
Cash and cash equivalents and current
receivables
140,040 274,111 (134,071)
Bank overdrafts and short-term loans (7,457) (2,384) (5,073)
Loans –
due within one year
(67,518) (47,224) (20,294)
Short-term borrowings from Group Companies (330,756) (287,483) (43,273)
Short-term borrowings (405,731) (337,091) (68,640)
Net current financial position (265,691) (62,980) (202,711)
Loans and receivables –
due after one year
3,107 10,105 (6,998)
(1)
Borrowings –
due after one year
(693,100) (605,820) (87,280)
Net financial position (955,684) (658,695) (296,989)

(1) Including the recognition at fair value of derivative instruments to hedge foreign exchange rate risk (cash flow hedges).

44. NON-RECURRING SIGNIFICANT EVENTS AND TRANSACTIONS

In compliance with Consob communication of 28th July 2006 a summary is given in the table below of the main events, transactions and actions which are non-recurring and which do not repeat frequently in the usual course of business. The overall net effect of such occurrences on the profit and loss, balance sheet and cash flow of the Company is not significant.

€ (thousands) 2018 2017 Change
2018/2017
Expenses related to the return of expired
pharmaceuticals
0 (163) 163
Company acquisition costs (1,592) 0 (1,592)
Costs for the acquisition of metoprolol rights 0 (522) 522
Costs of the "Buzzi Hospital renovation" 0 (2,000) 2,000
Total non-recurring operating expense (1,592) (2,685) 1,093

45. ATYPICAL AND/OR UNUSUAL TRANSACTIONS

In compliance with CONSOB communication of 28th July 2006, the Company performed no atypical and/or unusual transactions in 2018, as defined in that same communication, according to which atypical and/or unusual transactions are those which because of their significance or importance, the nature of the counterparties, the content of the transaction, the way in which the transfer price is decided and the timing of the event (close to the end of the financial year) might give rise to doubts concerning: the accuracy and completeness of the information in the financial statements, a conflict of interests, the security of the company's assets, the protection of the interests of minority shareholders.

46. RELATED-PARTY TRANSACTIONS

As at 31st December 2018, intercompany accounts with Group companies and the parent company Fimei S.p.A. showed payables of € 408,168 thousand and receivables of € 138,104 thousand. The most significant items were as follows:

  • receivables of € 9,964 thousand for loans granted to Group companies;
  • payables of € 84,924 thousand for loans received from Group companies;
  • trade receivables of € 53,777 thousand from subsidiaries;
  • trade payables to subsidiaries of € 8,392 thousand;
  • receivables from subsidiaries for the management of the centralised cash pooling treasury system amounting to € 74,339 thousand;
  • payables to subsidiaries for the management of the centralised cash pooling treasury system amounting to € 306,968 thousand;

Sales and services supplied to Group companies in 2018 amounted to € 223,223 thousand. Dividends were received during the year as follows: € 45,000 thousand from Bouchara Recordati S.a.s., € 80,000 thousand from Recordati Ireland Ltd, € 5,438 thousand from Recordati Orphan Drugs, € 1,373 thousand from Recordati Pharmaceuticals Ltd and € 3,351 thousand from Herbacos Recordati S.r.o.

Tax payables include those to the parent company Fimei S.p.A. amounting to € 7,884 thousand, which relate to the following:

  • receivables for tax refunds requested relating to an application for an IRES (corporate income tax) tax refund because it had not made an expense based deduction from IRAP (regional tax on production) relating to personnel expense for employees for the years 2007 until 2011 in accordance with Art. 2, paragraph 1-quater of Decree Law 201 of 2011;
  • tax liabilities for current taxation relating to taxes for the year calculated on the basis of estimated taxable income. That liability was transferred by the Recordati S.p.A. to the parent company as a consequence of opting for tax consolidation in accordance with articles 117 to 128 of Presidential Decree 917/1986 as amended by Legislative Decree 344/2003.

The following summary is set out in the table below in compliance with Consob Resolution No. 15519 of 27th July 2006:

Total Amount %
96,246 53,801 55.90
3,107 3,000 96.56
81,302 81,302 100.00
94,060 16,276 17.30
694,819 61,135 8.80
398,274 330,757 83.05
Related parties

Percentage of transactions or positions in the income

statement with related parties
Revenue 450,741 223,296 49.54
Income from investments 135,162 135,162 100.00
Costs of purchases and service provision 201,100 27,010 13.43
Financial income/(expense), net (17,242) (1,915) 11.11

Transactions and positions with related parties as a percentage of cash flows is basically the same as that for the income statement items because the transactions are conducted under normal market conditions.

It is underlined that no direct business was conducted during the year with the company that carries out management and co-ordination activities.

In compliance with the information required by article 38 of legislative decree 127/91, it is hereby specified that the overall compensation of the Directors and Statutory Auditors for the performance of their functions during 2018 amount to € 0.6 million and € 0.1 million respectively.

Following these extraordinary operations involving the life of the Company in relation to the sale of their controlling interest by the Recordati family to a consortium of investment funds controlled by CVC Capital Partners VII Limited, on 28th February 2019 the Board of Directors of the company, appointed by a Shareholders' Meeting held on 5th February 2019, noted the management and coordination exercised by Rossini Luxembourg S.àr.l., over Recordati S.p.A. pursuant to articles 2497 and following of the Italian Civil Code. We report that Rossini Luxembourg S.àr.l. was formed on 14th May 2018 and the first financial statements of the company have not yet been approved.

47. EVENTS AFTER THE REPORTING PERIOD

On 6th December 2018, following the sale of shares reported in the section "Other information" in the "Review of operations", the legal conditions arose for the initiation by Rossini Investimenti S.p.A. of a mandatory public bid, in accordance with articles 102 and 106, paragraph 1-bis of the Consolidated Finance Law for the purchase of a maximum of 97,735,180 ordinary shares of the Company, representing 46.735% of the share capital of Recordati S.p.A. and excluding 5,172,571 treasury shares of the issuer, equal to 2.473%, and including a maximum of 2,091,500 ordinary shares of Recordati S.p.A. if all the stock options resulting from currently valid stock option plans were to be exercised (the "Public Bid"). On 21st December 2018 the Public Bid was authorised by the Consob (Italian securities market authority) and the bid began on 2nd January 2019.

The bid period for the "Public Bid" ended on 1st February 2019 and 59,816 ordinary shares of Recordati S.p.A. were subscribed accounting for approximately 0.061% of the shares on which the bid was made and therefore equal to 0.029% of the share capital of the Company. Therefore, on 8th February 2019, the payment date of the consideration due to holders of the shares that were purchased and of the transfer of the same time of those shares to the bidder, the shares of Recordati S.p.A. held by Fimei S.p.A. (as the actual designated acquirer under the Public Bid) accounted for 51.820% of the share capital.

In consideration of the final results of the Public Bid, the necessary conditions for the exercise of the obligation and of the right to purchase in accordance with Art. 108, paragraphs 1 and 2, and 111 respectively of the Consolidated Finance Law did not arise.

Following the events described above, a Shareholders' Meeting appointed a new Board of Directors on 5th February 2019.

Except for the above, no significant events occurred subsequent to 31 December 2018.

48. PROPOSAL FOR THE ALLOCATION OF PROFIT FOR THE YEAR

A proposal is made for the profit for the year, amounting to € 217,330,294, to be allocated as follows:

  • to distribute to the shareholders a dividend of € 0.47 per share, in full balance of the interim 2018 dividend of € 0.45, to be paid to all shares outstanding at ex-dividend date, excluding those in treasury stock of the Company at that date, with ex-dividend on 23 April 2019. The full 2018 dividend is therefore of € 0.92 per share (€ 0.85 per share in 2017);
  • the remainder to retained earnings.

STATEMENT OF CHANGES IN DIRECT INVESTMENTS

€ (thousands) Balance as at Share capital sales and redemption Mergers Acquisitions subscription (Write-down) Write-ups IFRS valuation IFRS 2 Stock option valuation Balance as at 31st Dec 2017 31st Dec 2018 Investments in subsidiaries Casen Recordati S.L. – Spain 270,271 - - - - 676 270,947 Innova Pharma S.p.A. – Italy 10,564 - - - - - 2 10,566 Bouchara Recordati S.a.s. – France 56,158 - - - - - 532 56,690 Recordati Pharmaceuticals Ltd. – United Kingdom 22,589 - - - (6,200) - 14 16,403 Recordati Hellas Pharmaceuticals S.A. – Greece 4,790 - - - - - 50 4,840 Herbacos Recordati S.r.o. – Czech Republic 19,632 - - - - - 58 19,690 Recordati Polska Sp. z.o.o. – Poland 19,426 - - - - - 160 19,586 Italchimici S.p.A. – Italy 106,294 - - - - - - 106,294 Natural Point s.r.l. - Italy - - - 83,597 - - - 83,597 Recordati AG (formerly Pro Farma AG) - Switzerland 14,496 - 1,668 - - - 92 16,256 Recordati Rare Diseases Canada Inc. - Canada 245 - - - - - - 245 Recordati Rare Diseases Inc. – United States 2,026 - - - - - 280 2,306 Recordati Rare Diseases S.A. DE C.V. – Mexico 823 - - - - - 15 838 Recordati Rare Diseases Comercio Medicamentos Ltda - Brazil 206 - - - - - 9 215 Recordati Ireland LTD - Ireland 808 - - - - - 200 1.008 Recordati SA - Switzerland 1,668 - (1,668) - - - - - Recordati Orphan Drugs S.A.S. - France 52,843 - - - - - 383 53,226 Opalia Pharma S.A. - Tunisia 19,982 - - - - - - 19,982 Recordati Romania Srl - Rumania 1,481 - - - - - 32 1,513 Recordati Pharma GMBH - Germany 87,151 - - - - - 126 87,277 Accent LLC – Russian Federation 66,707 - - - - - - 66,707 Tonipharm S.A.S. – France - - - 72,636 - - - 72,636 758,160 - - 156,233 (6,200) - 2,629 910,822 Investments in other companies: Sifir S.p.A. – Reggio Emilia 0 - - - - - - 0 Consorzio Dafne – Reggello (Florence) 2 - - - - - - 2 Consorzio Nazionale Imballaggi – Rome 0 - - - - - - 0 Consorzio C4T – Pomezia (Rome) 0 - - - - - - 0 DGT - United States 0 - - - - - - 0 Codexis Inc. - United States 37 - - - - 34 - 71 Puretech Health p.l.c. - United States 16,153 - - - - 1,844 - 17,997 Fluidigm Corp. - United States 5 - - - - 3 - 8 16,197 - - - - 1,881 - 18,078

TOTAL 774,357 - - 156,233 (6,200) 1,881 2,629 928,900

SUMMARY STATEMENT OF DIRECT INVESTMENTS

€ (thousands) Balance as at 31st
Dec 2018
Percentage
ownership
Number of shares or quotas
possessed
Investments in subsidiaries
Casen Recordati S.L. – Spain 270,947 100.00 2,389,660
Innova Pharma S.p.A. – Italy 10,566 100.00 960,000
Bouchara – Recordati S.a.s. – France 56,690 100.00 10,000
Recordati Pharmaceuticals Ltd. – United Kingdom 16,403 100.00 15,000,000
Recordati Hellas Pharmaceuticals S.A. – Greece 4,840 100.00 1,005,000
Herbacos Recordati S.r.o. – Czech Republic 19,690 100.00 2,560
Recordati Polska Sp. z.o.o. – Poland 19,586 100.00 90,000
Italchimici S.p.A. – Italy 106,294 100.00 7,646,000
Natural Point s.r.l. - Italy 83,597 100.00 1
Recordati AG (formerly Pro Farma AG) - Switzerland 16,256 100.00 30,000
Recordati Rare Diseases Canada Inc. - Canada 245 100.00 1,000
Recordati Rare Diseases Inc. - United States 2,306 100.00 100
Recordati Rare Diseases Ukraine LLC - Ukraine 0 0.01 1
Recordati Rare Diseases S.A. DE C.V. – Mexico 838 99.998 49,999
Recordati Rare Diseases Comercio Medicamentos Ltda - Brazil 215 99.398 166
Recordati Ireland LTD - Ireland 1,008 100.00 200,000
Recordati Orphan Drugs S.A.S. - France 53,226 90.00 51,300
Opalia Pharma S.A. - Tunisia 19,982 90.00 612,000
Recordati Romania Srl - Rumania 1,513 100.00 500,000
Recordati Pharma GMBH - Germany 87,277 55.00 1
Accent LLC – Russian Federation 66,707 100.00 1
Tonipharm S.A.S. – France 72,636 100.00 2,577
910,822
Investments in other companies:
Sifir S.p.A. – Reggio Emilia 0 0.04 1,304
Consorzio Dafne – Reggello (Florence) 2 1.16 1
Consorzio Nazionale Imballaggi – Rome 0 n.s. 1
DGT - United States 0 n.s. n.s.
Codexis Inc. - United States 71 n.s 5.203
PureTech Health p.l.c. – United Kingdom 17,997 4.02 9,554,140
Fluidigm Corp. - United States 8 n,s 1,019
18,078
TOTAL 928,900

COMPARISON BETWEEN THE CARRYING AMOUNT OF DIRECT INVESTMENTS IN SUBSIDIARIES AND THEIR VALUATION USING THE EQUITY METHOD

358,017 1,139,987 198,058 1,059,379 910,822 1,538,157
Tonipharm S.A.S. - France 258 17,970 3,763 100,00 17,970 72,636 72,636
Accent LLC – Russian Federation* 0 330 18 100,00 330 66,707 28,150
Recordati Pharma GMBH - Germany 600 154,294 13,006 55,00 84,862 87,277 118,035
Recordati Romania Srl - Rumania 1,072 7,213 4,329 100,00 7,213 1,513 6,625
Opalia Pharma S.A. - Tunisia 2,815 11,879 3,043 90,00 10,692 19,982 28,311
Recordati Orphan Drugs S.A.S. - France 57,000 99,870 5,162 90,00 89,883 53,226 205,648
Recordati Ireland LTD - Ireland 200 122,673 56,985 100,00 122,673 1,008 107,520
Recordati Rare Diseases Comercio
Medicamentos Ltda - Brazil
0 341 94 99,398 339 215 339
Recordati Rare Diseases S.A. DE C.V. – Mexico
*
722 95 248 99,998 95 838 (32)
Recordati Rare Diseases Inc. – United States 10,462 161,398 36,803 100,00 161,398 2,306 154,468
Recordati Rare Diseases Canada Inc. –
Canada *
224 (305) (542) 100,00 (305) 245 (1,315)
Recordati AG (former Pro Farma AG) –
Switzerland
2,662 11,055 2,999 100,00 11,055 16,256 19,442
Natural Point S.r.l. – Italy 10 14,807 7,197 100,00 14,807 83,597 86,049
Italchimici S.p.A. – Italy 7,646 58,209 8,880 100,00 58,209 106,294 129,183
Recordati Polska S.p.z.o.o. – Poland * 1,046 2,850 2,227 100,00 2,850 19,586 16,726
Herbacos Recordati s.r.o. - Czech Republic 995 10,584 1,993 100,00 10,584 19,690 25,680
Recordati Hellas Pharmaceuticals S.A. –
Greece *
10,050 4,917 283 100,00 4,917 4,840 4,353
Recordati Pharmaceuticals Ltd. - United
Kingdom*
16,769 15,840 (1,035) 100,00 15,840 16,403 15,529
Bouchara Recordati S.a.s. - France 4,600 35,787 29,185 100,00 35,787 56,690 116,975
Innova Pharma S.p.A. - Italy 1,920 39,256 3,420 100,00 39,256 10,566 39,228
Investments
Casen Recordati S.L. - Spain
238,966 370,924 20,000 100,00 370,924 270,947 364,607
(B) (C)
€ (thousands) Share capital 31.12.2018
Equity
Profit (loss) %
Ownership
Corresponding
pro-rata equity
(A)
Carrying
amount
Valuation
Art. 2426
Difference A-B 148,557
Surplus C-B 627,335

* The carrying amount of the investment has not been adjusted to bring it into line with the amount calculated using the equity method because the results of the annual impairment test showed that the difference was not to be considered an indicator of permanent impairment.

SUMMARY INFORMATION ON SUBSIDIARIES

Subsidiaries Headquarters Currency Share capital Profit (loss)
2018
Equity
as at 31/12/2018
Revenue
2018
INNOVA PHARMA S.p.A.
Marketing and sales of pharmaceuticals
Italy €(000) 1,920 3,420 39,256 48,612
CASEN RECORDATI S.L.
Marketing and sales of pharmaceuticals
Spain €(000) 238,966 20,000 370,924 97,882
BOUCHARA RECORDATI S.A.S.
Research, production and sales of pharmaceuticals
France €(000) 4,600 29,185 35,787 15,838
REC.RARE DISEASES COMERCIO DE MEDICAMENTOS
LTDA.
Dormant, holds pharmaceutical marketing rights in
Brazil
Brazil BRL(000) 0 419 1,515 4,972
RECORDATI RARE DISEASES Inc.
Research, production and sales of pharmaceuticals
U.S.A. USD(000) 11,979 42,140 184,801 121,747
RECORDATI IRELAND LTD
Research, production and sales of pharmaceuticals
Ireland €(000) 200 56,985 122,673 293,073
LABORATOIRES BOUCHARA RECORDATI S.A.S.
Research, production and sales of pharmaceuticals
France €(000) 14,000 12,527 27,963 174,932
RECORDATI PHARMA GmbH
Marketing and sales of pharmaceuticals
Germany €(000) 600 13,006 154,294 121,172
RECORDATI PHARMACEUTICALS LTD.
Marketing and sales of pharmaceuticals
United
Kingdom
GBP(000) 15,000 (926) 14,169 1,763
RECORDATI HELLAS PHARMACEUTICALS S.A.
Marketing and sales of pharmaceuticals
Greece €(000) 10,050 283 4,917 17,499
JABA RECORDATI S.A.
Marketing and sales of pharmaceuticals
Portugal €(000) 2,000 3,878 11,506 40,864
JABAFARMA PRODUTOS FARMACÊUTICOS S.A.
Marketing of pharmaceuticals
Portugal €(000) 50 113 278 810
BONAFARMA PRODUTOS FARMACÊUTICOS S.A.
Marketing of pharmaceuticals
Portugal €(000) 50 475 1,206 2,287
RECORDATI ORPHAN DRUGS S.A.S.
Holding company
France €(000) 57,000 5,162 99,870 2,053
ORPHAN EUROPE SWITZERLAND GmbH
Marketing and sales of pharmaceuticals
Switzerland CHF(000) 20 19 358 137
ORPHAN EUROPE MIDDLE EAST FZ LLC
Marketing and sales of pharmaceuticals
United Arab
Emirates
€(000) 20 4,964 17,230 13,629
RECORDATI A.B.
Marketing and sales of pharmaceuticals
Sweden SEK(000) 100 4,999 9,351 38,521
ORPHAN EUROPE S.A.R.L.
Research, production and sales of pharmaceuticals
France €(000) 320 29,626 92,156 88,696
NATURAL POINT S.r.l.
*
Marketing and sales of pharmaceuticals
Italy €(000) 10 3,533 14,807 7,685
PRO FARMA GmbH
Marketing and sales of pharmaceuticals
Austria €(000) 35 (27) 369 403
TONIPHARM S.A.S *
Marketing and sales of pharmaceuticals
France €(000) 258 0 17.970 0
ORPHAN EUROPE UNITED KINGDOM LTD
Marketing and sales of pharmaceuticals
United
Kingdom
GBP(000) 50 2,080 2,181 5,676
Subsidiaries Headquarters Currency Share capital Profit (loss)
2018
Equity
as at 31/12/2018
Revenue
2018
ORPHAN EUROPE GERMANY GmbH
Marketing and sales of pharmaceuticals
Germany €(000) 26 5,154 9,669 13,526
ORPHAN EUROPE SPAIN S.L.
Marketing and sales of pharmaceuticals
Spain €(000) 1,775 2,614 4,804 7,136
ORPHAN EUROPE ITALY S.R.L.
Marketing and sales of pharmaceuticals
Italy €(000) 40 4,627 19,245 11,107
RECORDATI BVBA
Marketing and sales of pharmaceuticals
Belgium €(000) 19 1,566 2,954 5,985
FIC MEDICAL S.A.R.L.
Marketing of pharmaceuticals
France €(000) 174 8 1,194 2,110
HERBACOS RECORDATI s.r.o.
Research, production and sales of pharmaceuticals
Czech Republic CZK(000) 25,600 51,272 272,262 648,701
RECORDATI SK s.r.o.
Marketing and sales of pharmaceuticals
Slovak
Republic
€(000) 33 48 301 791
RUSFIC LLC
Marketing and sales of pharmaceuticals
Russian
Federation
RUB(000) 3,560 570,941 1,675,647 6,354,993
RECOFARMA ILAÇ Ve Hammaddeleri Sanayi Ve Ticaret L.Ş.
Marketing of pharmaceuticals
Turkey TRY(000) 10 17 236 444
RECORDATI ROMANIA S.R.L.
Marketing and sales of pharmaceuticals
Rumania RON(000) 5,000 20,186 33,640 56,518
RECORDATI İLAÇ Sanayi Ve Ticaret A.Ş.
Research, production and sales of pharmaceuticals
Turkey TRY(000) 180,000 57,098 315,046 403,119
RECORDATI POLSKA Sp. z o.o Marketing and sales of
pharmaceuticals
Poland PLN(000) 4,500 9,578 12,258 103,873
ACCENT LLC
Holds pharmaceutical marketing rights
Russian
Federation
RUB(000) 20 1,429 26,333 3,600
RECORDATI UKRAINE LLC
Marketing of pharmaceuticals
Ukraine UAH(000) 1,032 9,129 35,369 362,964
CASEN RECORDATI Portugal Unipessoal Ltd
Marketing and sales of pharmaceuticals
Portugal €(000) 100 119 487 551
OPALIA PHARMA S.A.
Research, production and sales of pharmaceuticals
Tunisia TND(000) 9,656 10,438 40,749 56,996
OPALIA RECORDATI SARL
Marketing of pharmaceuticals
Tunisia TND(000) 20 911 1,406 3,176
RECORDATI RARE DISEASE S.A. DE CV
Marketing of pharmaceuticals
Mexico MXN(000) 16,250 5,576 2,144 34,241
RECORDATI RARE DISEASE COLOMBIA S.A.S
Marketing of pharmaceuticals
Colombia COP(000) 150,000 5,007,437 9,174,311 19,726,863
RECORDATI RARE DISEASE CANADA INC.
Marketing of pharmaceuticals
Canada CAD(000) 350 (846) (476) 4,246
RECORDATI RARE DISEASE JAPAN K.K. *
Marketing of pharmaceuticals
Japan JPY/000 10,000 57,317 67,317 206,772
RECORDATI RARE DISEASE AUSTRALIA Pty Ltd. *
Marketing of pharmaceuticals
Australia AUD(000) 200 (290) (90) 190
ITALCHIMICI S.p.A.
Marketing and sales of pharmaceuticals
Italy €(000) 7,646 8,880 58,209 42,487
RECORDATI AG
Marketing and sales of pharmaceuticals
Switzerland CHF(000) 3,000 3,380 12,458 22,149

* Acquired in 2018.

DETAILS OF ITEMS IN SHAREHOLDERS' EQUITY

€ (thousands) Amount Possibility of
use
Amount
available
Amount
distributable
without tax
effects
Amount
distributable
with tax effects
Notes
Share capital 26,141
Additional paid-in capital reserve 83,718 A B C 83,718 15,074 68,644 1
Revaluation reserve 2,602 A B C 2,602 0 2,602
Statutory reserve 5,228 B 0 0 0
Treasury stock reserve (145,608) (145,608) (145,608) 0
Other reserves
Gain on merger 29,813 A B C 29,813 29,813 0
Extraordinary reserve 73,184 A B C 73,184 73,184 0
Reserve under Art. 13 Par. 6 of Legislative Decree
124/1993
99 A B C 99 0 99
Research and investment grants 17,191 A B C 17,191 1,227 15,964 2
Extraordinary VAT concession reserve 517 A B C 517 0 517
Southern Italy investment fund 3,632
IAS reserve 113,972 A B C 113,972 113,972 0
Interim dividends (91,761) (91,761) (91,761) 0
Net income (loss) for the period 217,330 A B C 217,330 217,330 0
Total shareholders' equity 336,058 301,057 213,231 87,826

Legend:

A for share capital increase

B to replenish losses

C to distribute to shareholders

Notes:

  • 1 The additional paid-in capital reserve may be distributed when the statutory reserve has reached one fifth of the share capital
  • 2 The research and investment grant reserve has already been subject to taxation of € 1,227 thousand.

DISCLOSURE OF AUDITORS' FEES FOR ACCOUNTING AUDITS AND OTHER SERVICES

Amounts in euro
Type of service Firm providing the service Remuneration
Accounting audit Auditor of the Company 130,200
Certification services Auditor of the Company 44,000
Due diligence Auditor of the Company 223,000
Other services Auditor of the Company 30,000

CERTIFICATION IN RESPECT OF THE FINANCIAL STATEMENTS UNDER ARTICLE 154-BIS OF LEGISLATIVE DECREE 58/98

  1. The undersigned, Andrea Recordati, in his capacity as Chief Executive Officer, and Fritz Squindo, as the Manager responsible for the preparation of the financial statements of Recordati S.p.A., pursuant to the provisions or article 154-bis, clauses 3 and 4, of Legislative Decree No. 58 of 24th February 1998, hereby certify it to

  2. the adequacy with respect to the Company structure and

  3. the effective application,

of the administrative and accounting procedures applied in the preparation of the separate company financial statements for the financial year 2018.

  1. Furthermore, it is certified that:

2.1 The financial statements as at and for the year ended 31st December 2018:

  • have been prepared in accordance with the international accounting standards, recognised by the European Union pursuant to Regulation (EC) 1606/2002 of the European Parliament and Council, dated 19th July 2002;
  • correspond to the amounts shown in the Company's accounts, books and records;
  • provide a fair and correct representation of the financial conditions, results of operations and cash flows of the Company.

2.2 The report on operations includes a reliable operating and financial review of the Company as well as a description of the main risks and uncertainties to which it is exposed.

Milan, 28th February 2019

Chief Executive Officer Manager responsible for preparing the Company's financial reports

Andrea Recordati Fritz Squindo

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