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Recordati Industria Chimica e Farmaceutica

Quarterly Report May 8, 2019

4056_rns_2019-05-08_f2a70a67-6683-49dc-93f3-ec966fefc90c.pdf

Quarterly Report

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INTERIM REPORT FIRST QUARTER 2019

MANAGEMENT REVIEW HIGHLIGHTS

First quarter 2019

REVENUE

€ (thousands) First quarter First quarter Change
2019 % 2018 % 2019/2018 %
Total revenue 382,990 100.0 366,500 100.0 16,490 4.5
Italy 82,223 21.5 78,926 21.5 3,297 4.2
International 300,767 78.5 287,574 78.5 13,193 4.6

KEY CONSOLIDATED P&L DATA

€ (thousands) First quarter
2019
% of
revenue
First quarter
2018
% of
revenue
Change
2019/2018
%
Revenue 382,990 100.0 366,500 100.0 16,490 4.5
EBITDA(1) 143,939 37.6 134,373 36.7 9,566 7.1
Operating income 126,010 32.9 120,531 32.9 5,479 4.5
Net income 92,112 24.1 86,592 23.6 5,520 6.4

(1) Operating income before depreciation, amortization and write down of both tangible and intangible assets.

KEY CONSOLIDATED B/S DATA

€ (thousands) 31 March 31 December Change %
2019 2018 2019/2018
Net financial position(2) (555,716) (588,380) 32,664 (5.6)
Shareholders' equity 1,067,314 963,586 103,728 10.8

(2) Short‐term financial investments, cash and cash equivalents, less bank overdrafts and loans which include the measurement at fair value of hedging derivatives.

The financial results obtained in the first quarter of the year confirm the continued growth of the Group. Consolidated revenue is € 383.0 million, up by 4.5% compared to the same period of the preceding year. International sales grow by 4.6%. EBITDA, at 37.6% of sales, is € 143.9 million, an increase of 7.1% over the first quarter of 2018. Operating income, at 32.9% of sales, is € 126.0 million, an increase of 4.5% over the same period of the preceding year. Net income, at 24.1% of sales, is € 92.1 million, an increase of 6.4% over the first quarter of 2018.

Net financial position at 31 March 2019 records a net debt of € 555.7 million compared to net debt of € 588.4 million at 31 December 2018. Shareholders' equity is € 1,067.3 million.

CORPORATE DEVELOPMENT NEWS

In February, Recordati signed a license agreement with Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics Inc., for the exclusive rights to commercialize Juxtapid®, currently approved for the treatment of homozygous familial hypercholesterolemia (HoFH), in Japan. The agreement includes a right of first negotiation for product commercialization in Japan of any potential new indications that may be developed by Aegerion. Upon signing of the agreement an upfront payment of \$ 25 million is due to Aegerion, in addition to a near term milestone

of \$ 5 million. Commercial milestones and royalty payments are also included as is customary. In 2018 sales of the product in Japan were of \$ 10.8 million. Juxtapid® (lomitapide) is a microsomal triglyceride transfer protein inhibitor. It was approved, and granted orphan market exclusivity, in September 2016 by Japan's Ministry of Health, Labor & Welfare (MHLW) for patients with homozygous familial hypercholesterolemia (HoFH). HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL‐C ("bad" cholesterol) from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries. The addition of Juxtapid® to our portfolio of rare disease products in Japan is very important for the development of our recently established subsidiary in this country, given its potential for significant growth.

REVIEW OF OPERATIONS

Net revenue in the first quarter of 2019 is € 383.0 million, up 4.5% over the same period of the preceding year, and includes sales generated by Natural Point S.r.l., consolidated as from 1 July 2018, of € 4.0 million, sales generated by Tonipharm S.A.S., acquired at the end of 2018 and consolidated as from 1 January 2019, of € 5.8 million and the sales of Juxtapid®, a product acquired under license in February 2019 in Japan, of € 0.7 million, in addition to an estimated negative currency exchange rate effect of € 5.9 million. Excluding these items growth would have been of 3.2%. International sales grow by 4.6% to € 300.8 million, which represent 78.5% of total sales. Pharmaceutical sales are € 371.3 million, up by 4.1% while pharmaceutical chemicals sales are € 11.7 million, up by 18.6%, and represent 3.1% of total revenues.

The Group's pharmaceutical business, which represents 97.0% of total revenue, is carried out in the main European markets, including Central and Eastern Europe, in Russia, Turkey, North Africa, the United States of America, Canada, Mexico, in some South American countries, in Japan and Australia through our own subsidiaries and in the rest of the world through licensing agreements with pharmaceutical companies of high standing.

The performance of products sold directly in more than one country (corporate products) during the first quarter of 2019 is shown in the table below.

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
%
Zanidip® (lercanidipine) 37,413 36,516 897 2.5
Zanipress® (lercanidipine+enalapril) 14,213 17,898 (3,685) (20.6)
Urorec® (silodosin) 27,847 26,712 1,135 4.2
Livazo® (pitavastatin) 13,162 12,361 801 6.5
Seloken®/Seloken® ZOK/Logimax®
(metoprolol/metoprolol+felodipine)
23,040 23,273 (233) (1.0)
Other corporate products* 79,704 78,037 1,667 2.1
Drugs for rare diseases 56,156 54,828 1,328 2.4

* Include the OTC corporate products for an amount of € 31.1 million in 2019 and € 28.5 million in 2018 (+8.9%).

Zanidip® is a specialty containing lercanidipine, Recordati's original calcium channel blocker for the treatment of hypertension. Our lercanidipine based products are sold directly to the market by our own marketing organizations in Europe, including Central and Eastern Europe, in Russia, in Turkey and in North Africa. In the other markets they are sold by licensees, and in some of the above co‐marketing agreements are in place.

Total lercanidipine sales 37,413 36,516 897 2.5
Sales to licensees 18,720 18,388 332 1.8
Direct sales 18,693 18,128 565 3.1
€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
%

Lercanidipine direct sales are up by 3.1% mainly due to the increase of sales in Germany, Poland and Russia as well as to the direct sales by our organizations now operational in the Nordic countries and in Benelux, areas where previously sales were realized by our licensees. Sales to licensees, which represent 50.0% of total lercanidipine sales, are up by 1.8%.

Zanipress® is an original specialty also indicated for the treatment of hypertension developed by Recordati which consists of a fixed combination of lercanidipine with enalapril. This product is successfully marketed directly by Recordati and/or by its licensees in 30 countries.

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
%
Direct sales 12,122 13,692 (1,570) (11.5)
Sales to licensees 2,091 4,206 (2,115) (50.3)
Total lercanidipine+enalapril sales 14,213 17,898 (3,685) (20.6)

Direct sales of Zanipress® in the first quarter of 2019 are down by 11.5% due to competition from generic versions of the product mainly in France and Germany. Sales to licensees represent 14.7% of total Zanipress® sales and are down by 50.3% mainly due to lower sales to licensees in France.

Urorec® (silodosin) is a specialty indicated for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). Currently the product has been successfully launched in 40 countries with sales of € 27.8 million in the first quarter of 2019, up 4.2% due to the good performance of the product in all main markets.

Sales of Livazo® (pitavastatin), a statin indicated for the reduction of elevated total and LDL cholesterol, in Spain, Portugal, Ukraine, Greece, Switzerland, Russia, other C.I.S. countries and Turkey, are € 13.2 million in the first quarter of 2019, up by 6.5% due mainly to the performance of the product in Turkey.

Sales of Seloken®/Seloken® ZOK (metoprolol) and associated Logimax® fixed dose combination (metoprolol and felodipine), metoprolol based products belonging to the beta‐blocker class of drugs widely used in the treatment of various cardiovascular disorders, are of € 23.0 million in the first quarter of 2019, substantially unchanged compared to the same period of the preceding year.

In the first quarter of 2019 sales of other corporate products totaled € 79.7 million, up by 2.1% compared to the same period of the preceding year. Other corporate products comprise both prescription and OTC products and are: Reagila® (cariprazine), Lomexin® (fenticonazole), Urispas® (flavoxate), Kentera® (oxybutynin transdermal patch), TransAct® LAT (flurbiprofen transdermal patch), Rupafin®/Wystamm® (rupatadine), Lopresor® (metoprolol), Procto‐Glyvenol® (tribenoside), Tergynan® (fixed association of anti‐infectives) as well as CitraFleet®, Casenlax®, Fleet enema, Phosphosoda®, Reuflor®/Reuteri® (lactobacillus Reuteri) and Lacdigest® (tilactase), gastroenterological products, Polydexa®, Isofra® and Otofa®, ENT anti‐infective products, the Hexa line of products indicated for seasonal disorders of the upper respiratory tract, Abufene® and Muvagyn® for gynecological use, Virirec® (alprostadil) and Fortacin® (lidocaine+prilocaine) for male sexual disorders.

In the first quarter of 2019, our specialties indicated for the treatment of rare diseases, marketed directly throughout Europe, in the Middle East, in the U.S.A., Canada, Mexico, in some South American countries, in Japan and Australia, and through partners in other parts of the world, generated sales of € 56.2 million, up by 2.4%, despite competition from a generic version of Cosmegen® in the United States of America.

The pharmaceutical sales of the Recordati subsidiaries, which include the abovementioned product sales, are shown in the following table.

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
%
Italy 80,155 76,454 3,701 4.8
France 37,907 34,148 3,759 11.0
Germany 36,101 33,407 2,694 8.1
Russia, other C.I.S. countries and Ukraine 28,344 32,141 (3,797) (11.8)
U.S.A. 26,336 25,571 765 3.0
Spain 22,792 21,220 1,572 7.4
Turkey 22,009 22,824 (815) (3.6)
Portugal 11,011 10,221 790 7.7
Other C.E.E. countries 19,482 16,402 3,080 18.8
Other Western European countries 17,270 13,916 3,354 24.1
North Africa 11,404 10,289 1,115 10.8
Other international sales 58,446 60,016 (1,570) (2.6)
Total pharmaceutical revenue 371,257 356,609 14,648 4.1

Both years include sales as well as other income.

Sales in countries affected by currency exchange oscillations are shown hereunder in their relative local currencies.

Local currency (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
%
Russia (RUB) 1,695,049 1,802,703 (107,654) (6.0)
Turkey (TRY) 128,499 100,083 28,416 28.4
U.S.A. (USD) 31,339 32,394 (1,055) (3.3)

Net revenues in Russia and in Turkey exclude sales of products for rare diseases. Sales in the U.S.A. include the sales in Canada.

Sales of pharmaceuticals in Italy are up by 4.8% compared to those of the same period of the preceding year. Worth mentioning is the good performance of Urorec®, Cardicor® (bisoprolol) and Aircort® (budesonide), as well as the sales of Natural Point S.r.l., the Italian company acquired in June 2018 and consolidated as from July.

Pharmaceutical sales in France are up by 11.0%. Worth mentioning is the good performance of Transipeg® and Colopeg®, the gastrointestinal products acquired from Bayer in December 2017, as well as the addition to the product portfolio of Ginkor® and Alodont®, the main products belonging to Tonipharm S.A.S., the French company acquired in December 2018 and consolidated as from 1 January 2019.

In Germany sales are up by 8.1% mainly thanks to the sales generated by Reagila® (cariprazine), a new drug for the treatment of schizophrenia launched in 2018, and the growth of Ortoton® (methocarbamol).

Revenue generated in Russia, Ukraine and in the countries within the Commonwealth of Independent States (C.I.S.) is € 28.3 million, down by 11.8% compared to the same period of the preceding year and includes estimated currency exchange losses of € 1.3 million. Sales in Russia, in local currency, are RUB 1,695.0 million, down by 6.0% compared to the same period of the preceding year due mainly to the procurement policies of the main wholesalers. Worth mentioning is the significant growth of the corporate products Procto‐Glyvenol®, Urorec®, Livazo®, Zanidip® and Lomexin®. Sales generated in Ukraine and in the C.I.S. countries, mainly Belarus, Georgia and Armenia are growing and have reached € 5.4 million.

The Group's pharmaceutical business in the U.S.A. is dedicated to the marketing of products for the treatment of rare diseases. The main products are Panhematin® (haemin for injection) for the amelioration of recurrent attacks of acute intermittent porphyria, Carbaglu® (carglumic acid), indicated for the treatment of acute hyperammonaemia associated with NAGS deficiency, Cystadane® (betaine anhydrous) indicated in the treatment of homocystinuria and Cosmegen® (dactinomycin for injection) used in the treatment of three rare cancers. Sales in the first quarter of 2019 are € 26.3 million, up by 3.0%. In local currency sales are down by 3.3% due to competition from a generic version of Cosmegen®. Worth mentioning is the significant growth of Carbaglu®.

In Spain sales are € 22.8 million, up by 7.4% mainly due to the performance of Livazo®, Urorec®, Bi‐OralSuero® and Casenlax®. Sales of the treatments for rare diseases are also growing significantly.

Sales in Turkey are down by 3.6% and include a negative currency exchange effect estimated to be of € 6.4 million. In local currency sales of our Turkish subsidiary grow by 28.4% thanks to the good performance of all the corporate products, in particular Urorec®, Zanipress®, Lercadip®, Livazo® and Procto‐Glyvenol®, as well as the local products, Kreval® (butamirate citrate), Mictonorm® (propiverine), Aknetrent® (isotretinoin) and Cabral® (phenyramidol).

Sales in Portugal are up by 7.7% thanks mainly to the good performance of TransAct® LAT and Livazo®.

Sales in other Central and Eastern European countries include the sales of Recordati subsidiaries in Poland, the Czech Republic, Slovakia, Romania, Bulgaria and the Baltic countries, in addition to sales of rare disease treatments in this area as well as in Hungary. In the first quarter of 2019 overall sales are up by 18.8% thanks mainly to the

growth of sales in Poland and the Czech Republic. Sales of the treatments for rare diseases in these countries are up by 29.7%.

Sales in other countries in Western Europe, up by 24.1%, comprise sales of products for the treatment of rare diseases in these countries (+20.1%) and sales of specialty and primary care products generated by the Recordati subsidiaries in the United Kingdom, Ireland, Greece, Switzerland, in the Nordic countries (Finland, Sweden, Denmark, Norway and Iceland) and in BeNeLux. The increase in sales is to be attributed mainly to the direct commercialization by Recordati organizations in the Nordic countries and in BeNeLux where sales were previously made through licensees.

Sales in North Africa are € 11.4 million, up by 10.8%, and comprise both the export sales generated by Laboratoires Bouchara Recordati in these territories, in particular in Algeria, and sales generated by Opalia Pharma, the Group's Tunisian subsidiary. Sales in Tunisia in the first quarter of 2019, in local currency, are up by 38.1%.

Other international sales are down by 2.6% as compared to the same period of the preceding year and comprise the sales to, and other revenues from, our licensees for our corporate products, Laboratoires Bouchara Recordati's and Casen Recordati's export sales, as well as the sales of products for the treatment of rare diseases in the rest of the world. The reduction is to be attributed mainly to the integration in local portfolios of products previously sold through licensing agreements and to lower sales of Zanipress® to licensees following the entry of generic versions of the product.

FINANCIAL REVIEW

INCOME STATEMENT

The following table shows the profit and loss accounts, including their expression as a percent of sales and change versus the first quarter of 2018:

€ (thousands) First quarter
2019
% of
revenue
First quarter
2018
% of
revenue
Change
2019/2018
%
Revenue 382,990 100.0 366,500 100.0 16,490 4.5
Cost of sales (116,466) (30.4) (109,288) (29.8) (7,178) 6.6
Gross profit 266,524 69.6 257,212 70.2 9,312 3.6
Selling expenses (94,563) (24.7) (91,687) (25.0) (2,876) 3.1
R&D expenses (29,152) (7.6) (27,664) (7.5) (1,488) 5.4
G&A expenses (17,254) (4.5) (16,372) (4.5) (882) 5.4
Other income (expense), net 455 0.1 (958) (0.3) 1,413 n.s.
Operating income 126,010 32.9 120,531 32.9 5,479 4.5
Financial income (expense), net (3,991) (1.0) (4,856) (1.3) 865 (17.8)
Pretax income 122,019 31.9 115,675 31.6 6,344 5.5
Provision for income taxes (29,907) (7.8) (29,083) (7.9) (824) 2.8
Net income 92,112 24.1 86,592 23.6 5,520 6.4
Attributable to:
Equity holders of the parent 92,100 24.0 86,580 23.6 5,520 6.4
Non‐controlling interests 12 0.0 12 0.0 0 0.0

Revenue for the period is € 383,0 million, an increase of € 16.5 million compared to the first quarter of 2018. For a detailed analysis please refer to the preceding "Review of Operations".

Gross profit is € 266.5 million with a margin of 69.6% on sales, a slight decrease compared to that of the same period of the preceding year due mainly to price and currency effects.

Selling expenses increase less than sales and are therefore down as a percent of revenue compared to the same period of the preceding year thanks to the increased efficiency of the group's commercial organizations.

R&D expenses are € 29.2 million, up by 5.4% compared to those recorded in the first quarter of 2018 due to the advancement of new development programs and the amortization of the amounts allocated to intangible assets following the acquisition of Natural Point S.r.l. and of Tonipharm S.A.S. during 2018.

G&A expenses are up by 5.4% but remain unchanged as percent of sales.

Net financial charges are € 4.0 million, a reduction of € 0.9 million compared to the same period of the preceding year due to the realization of net currency exchange gains as opposed to net currency exchange losses incurred in the first quarter 2018.

The effective tax rate during the period is 24.5%, lower than that of the same period of the preceding year.

Net income at 24.1% of sales is € 92.1 million, an increase of 6.4% over the same period of the preceding year and benefited from the reduction of financial charges the effective tax rate.

NET FINANCIAL POSITION

The net financial position is set out in the following table:

Net financial position (555,716) (588,380) 32,664 (5.6)
Loans and leases – due after one year (1) (638,714) (634,233) (4,481) 0.7
Net liquid assets 82,998 45,853 37,145 81.0
Loans and leases – due within one year (77,902) (135,278) 57,376 (42.4)
Bank overdrafts and short‐term loans (23,777) (16,905) (6,872) 40.7
Cash and short‐term financial investments 184,677 198,036 (13,359) (6.7)
€ (thousands) 31 March
2019
31 December
2018
Change
2019/2018
%

(1) Includes change in fair value of the relative currency risk hedging instruments (cash flow hedge).

At 31 March 2019 the net financial position shows a net debt of € 555.7 million compared to net debt of € 588.4 million at 31 December 2018. During the period an amount of \$ 25.0 million were paid up‐front at the signing of the license agreement with Aegerion Pharmaceuticals Inc. covering the exclusive rights to Juxtapid® (lomitapide) in Japan and a € 20,0 million milestone was paid to Helsinn as per the license agreement for Ledaga® (chlormethine). Furthermore, the first time application of IFRS 16 gave rise to medium/long term debt of € 25.0 million.

During the period the privately placed notes issued by Recordati Rare Diseases on 13 June 2013 for a total of \$ 70 million were fully repaid. The euro equivalent amount paid was of € 61.3 million.

BUSINESS OUTLOOK

The growth of Group's business continued during April. For the 2019‐2021 three‐year period expectations are as follows:

For 2019, as already announced on 21 December 2018, our targets are to achieve sales ranging from € 1,430 million to € 1,450 million, an EBITDA of between € 520 and € 530 million, EBIT of between € 460 and € 470 million and net income of between € 330 and € 335 million.

For 2021, including the contribution of further acquisitions which may be completed within the period under analysis, we expect to achieve sales of around € 1,700 million, EBITDA of around € 650 million, operating income of around € 560 million and net income of around € 400 million.

Milan, 8 May 2019

on behalf of the Board of Directors the Chief Executive Officer Andrea Recordati

CONSOLIDATED CONDENSED FINANCIAL STATEMENTS AT 31 MARCH 2019

The consolidated condensed financial statements of the Recordati group for the period ended 31 March 2019 have been prepared by Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali 1, Milan, Italy, in condensed form in accordance with the IAS 34 requirements for interim reporting. Details regarding the accounting principles adopted by the Group are set out in Note 2.

The publication of these consolidated condensed financial statements was authorized by the Board of Directorts on 8 May 2019 and is available at the company's headquarters.

RECORDATI S.p.A. AND SUBSIDIARIES

CONSOLIDATED INCOME STATEMENT FOR THE PERIOD ENDED 31 MARCH 2019

INCOME STATEMENT

€ (thousands) First quarter First quarter
2019 2018
Revenue 382,990 366,500
Cost of sales (116,466) (109,288)
Gross profit 266,524 257,212
Selling expenses (94,563) (91,687)
R&D expenses (29,152) (27,664)
G&A expenses (17,254) (16,372)
Other income (expense), net 455 (958)
Operating income 126,010 120,531
Financial income (expense), net (3,991) (4,856)
Pretax income 122,019 115,675
Provision for income taxes (29,907) (29,083)
Net income 92,112 86,592
Attributable to:
Equity holders of the parent 92,100 86,580
Non‐controlling interests 12 12
Earnings per share
Basic € 0.451 € 0.417
Diluted € 0.440 € 0.414

Earnings per share (EPS) are based on average shares outstanding during each year, 204,019,974 in 2019 and 207,417,146 in 2018, net of average treasury stock which amounted to 5,105,182 shares in 2019 and to 1,708,010 shares in 2018. Diluted earnings per share is calculated taking into account stock options granted to employees.

CONSOLIDATED BALANCE SHEET AT 31 MARCH 2019

ASSETS

€ (thousands) 31 March 31 December
2019 2018
Non‐current assets
Property, plant and equipment 125,946 103,582
Intangible assets 688,866 672,462
Goodwill 579,241 579,557
Other investments 21,491 20,773
Other non‐current assets 5,991 5,860
Deferred tax assets 79,404 81,267
Total non‐current assets 1,500,939 1,463,501

Current assets

Inventories 202,987 206,084
Trade receivables 286,743 245,742
Other receivables 29,141 38,462
Other current assets 9,394 5,193
Fair value of hedging derivatives (cash flow hedge) 7,965 6,414
Short‐term financial investments,
cash and cash equivalents 184,677 198,036
Total current assets 720,907 699,931
Total assets 2,221,846 2,163,432

CONSOLIDATED BALANCE SHEET AT 31 MARCH 2019

EQUITY AND LIABILITIES

€ (thousands) 31 March 31 December
2019 2018
Shareholders' equity
Share capital 26,141 26,141
Additional paid‐in capital 83,719 83,719
Treasury stock (134,151) (145,608)
Hedging reserve (cash flow hedge) (8,749) (8,399)
Translation reserve (149,322) (154,146)
Other reserves 45,006 43,081
Retained earnings 1,204,126 897,990
Net income for the year 92,100 312,376
Interim dividend (91,761) (91,761)
Group shareholders' equity 1,067,109 963,393
Non‐controlling interests 205 193
Shareholders' equity 1,067,314 963,586
Non‐current liabilities
Loans – due after one year 646,679 640,647
Staff leaving indemnities 19,433 19,547
Deferred tax liabilities 45,800 45,653
Other non‐current liabilities 3,257 3,257
Total non‐current liabilities 715,169 709,104
Current liabilities
Trade payables 139,234 165,020
Other payables 88,355 85,534
Tax liabilities 61,815 42,149
Other current liabilities 17,995 19,359
Provisions 20,949 21,446
Fair value of hedging derivatives (cash flow hedge) 9,336 9,746
Loans – due within one year 77,902 130,583
Bank overdrafts and short‐term loans 23,777 16,905
Total current liabilities 439,363 490,742
Total equity and liabilities 2,221,846 2,163,432

STATEMENT OF COMPREHENSIVE INCOME FOR THE PERIOD ENDED 31 MARCH 2019

€ (thousands) First quarter
2019
First quarter
2018
Net income for the year 92,112 86,592
Gains/(losses) on cash flow hedges, net of tax (350) (1,410)
Gains/(losses) on translation of foreign financial statements 4,824 (11,389)
Gains/(losses) on investments booked to equity, net of tax 600 243
Income and expense for the year recognized directly in equity 5,074 (12,556)
Comprehensive income for the year 97,186 74,036
Attributable to:
Equity holders of the parent 97,174 74,024
Minority interests 12 12
Per share data
Basic € 0.476 € 0.357

The notes to the financial statements are an integral part of the consolidated condensed financial statements.

RECORDATI S.p.A. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY

€ (thousands) Share
capital
Additional
paid‐in
capital
Treasury
stock
Hedging
reserve
Translation
reserve
Other
reserves
Retained
earnings
Net income
for the
period
Interim
dividend
Non‐con‐
trolling
interests
Total
Balance at 31.12.2017 26,141 83,719 (17,029) (5,867) (124,004) 40,684 822,154 288,762 (87,470) 147 1,027,237
Allocation of 2017 net
income:
‐ Retained earnings 288.762 (288,762) 0
Change in the reserve for
share based payments
608 72 680
Purchase of own shares (169,769) (169,769)
Disposal of own shares 1,931 (1,042) 889
Other changes 3 3
Comprehensive income
for the year (1,410) (11,389) 243 86,580 12 74,036
Balance at 31.3.2018 26,141 83,719 (184,867) (7,277) (135,393) 41,535 1,109,949 86,580 (87,470) 159 933,076
Balance at 31.12.2018 26,141 83,719 (145,608) (8,399) (154,146) 43,081 897,990 312,376 (91,761) 193 963,586
Allocation of 2018 net
income:
‐ Retained earnings 312,376 (312,376) 0
Change in the reserve for
share based payments
1,325 438 1,763
Disposal of own shares 11,457 (6,679) 4,778
Other changes 1 1
Comprehensive income
for the year
(350) 4,824 600 92,100 12 97,186
Balance at 31.3.2019 26,141 83,719 (134,151) (8,749) (149,322) 45,006 1,204,126 92,100 (91,761) 205 1,067,314

CONSOLIDATED CASH FLOW STATEMENT FOR THE PERIOD ENDED 31 MARCH 2019

€ (thousands) First quarter
2019
First quarter
2018
Operating activities
Cash flow
Net Income 92,112 86,592
Depreciation of property, plant and equipment 5,870 3,402
Amortization of intangible assets 12,059 10,440
Total cash flow 110,041 100,434
(Increase)/decrease in deferred tax assets 2,065 (2,120)
Increase/(decrease) in staff leaving indemnities (114) (117)
Increase/(decrease) in other non‐current liabilities (63) 244
111,929 98,441
Changes in working capital
Trade receivables (41,001) (35,190)
Inventories 3,097 (2,216)
Other receivables and other current assets 5,120 11,934
Trade payables (25,786) 78
Tax liabilities 19,666 12,926
Other payables and other current liabilities 1,457 5,965
Provisions (497) (4,575)
Changes in working capital (37,944) (11,078)
Net cash from operating activities 73,985 87,363
Investing activities
Net (investments)/disposals in property, plant and equipment (4,090) (3,444)
Net (investments)/disposals in intangible assets (25,720) (13,984)
Net (increase)/decrease in other non‐current receivables (131) 292
Net cash used in investing activities (29,941) (17,136)
Financing activities
Medium/long term loans granted 659 74
Re‐payment of loans (73,849) (11,837)
Purchase of treasury stock 0 (169,769)
Sale of treasury stock 4,778 889
Effect on shareholders' equity of application of IAS/IFRS 1,763 680
Other changes in shareholders' equity 1 3
Net cash from/(used in) financing activities (66,648) (179,960)
Changes in short‐term financial position (22,604) (109,733)
Short‐term financial position at beginning of year * 181,131 285,500
Change in translation reserve 2,373 (3,549)
Short‐term financial position at end of period * 160,900 172,218

* Includes cash and cash equivalents net of bank overdrafts and short‐term loans.

RECORDATI S.p.A. AND SUBSIDIARIES NOTES TO THE CONSOLIDATED CONDENSED FINANCIAL STATEMENTS FOR THE PERIOD ENDED 31 MARCH 2019

1. GENERAL

The consolidated condensed financial statements at 31 March 2019 comprise Recordati S.p.A. (the Company) and subsidiaries controlled by the Company. The companies included in the consolidated accounts, the consolidation method applied, their percentage of ownership and a description of their activity are set out in attachment 1.

During the first quarter 2019 the consolidation perimeter changed consequent to the establishment of the company Recordati Bulgaria Ltd. The recognition in the accounts of the acquisition in 2018 of Natural Point S.r.l. and of Tonipharm S.a.s. are not yet definite as allowed by IFRS 3.

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

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The first quarter consolidated condensed financial statements were prepared in accordance with the IAS 34 requirements for interim reporting. The statements do not include the full information required for the annual financial statements and must therefore be read together with the annual report for the full year ended 31 December 2018, prepared in accordance with the International Financial Reporting Standards (IFRS), issued by the International Accounting Standards Board (IASB) and adopted by the European Union.

The preparation of the interim financial statements requires management to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements. If in the future such estimates and assumptions, which are based on management's best judgment at the date of the interim financial statements, deviate from the actual circumstances, the original estimates and assumptions will be modified as appropriate in the period in which the circumstances change. Valuation exercises, in particular complex calculations such as those required to identify impairment loss, are carried out in depth only for the preparation of the year‐end consolidated financial statements, except when there is an indication that an asset has suffered an impairment loss which would require an immediate estimate of the loss.

Disclosure of the net financial position and of events subsequent to the end of the period are included under the preceding management review.

Application of new accounting principles

As from 1 January 2019 the Group has applied the new accounting principle IFRS 16 "Leases" which substitutes the accounting principle IAS 17 and its relative interpretations and eliminates the classification of leases as operating or financial in the financial statements of the lessees. In substance, for all leases unless the lease term is 12 months or less or the underlying asset has a low value, the lessee is required to recognize a right‐ of‐use asset and a lease liability representing the obligation of making the payments stipulated in the contract, as well as the effects on profit and loss of the amortization of the asset and the financial expense connected with the financial liability.

The Group applied the new principle at the date of first time application using the modified retrospective approach which provides for the cumulative effect of the adoption of IFRS 16 to be recognized as an adjustment to retained earnings at 1 January 2019 without restating the comparative information. Consequently, right‐of‐use assets and a lease liabilities were recognized at 1 January 2019 for an amount of € 25.0 million.

During the first quarter 2019 further right‐of‐use assets and the corresponding lease liabilities were recognized for an amount of € 0.7 million, while payments were booked for € 2.1 million. In the profit and loss statement the new treatment of lease contracts determined a substantially unchanged operating income with a positive effect on EBITDA of € 2.3 million and an increase in financial charges of € 0.2 million.

Property financial leases at 31 December 2018 were already recognized as prescribed by IFRS 16 in accordance with IAS 17 requirements for financial leases.

3. REVENUE

Net revenue for the first quarter of 2019 is € 383.0 million (€ 366.5 million in the same period of the preceding year) and can be broken down as follows:

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
Net sales 377,352 362,767 14,585
Royalties 1,534 1,780 (246)
Up‐front payments 1,676 35 1,641
Miscellaneous items 2,428 1,918 510
Total revenue 382,990 366,500 16,490

Revenue from up‐front payments refers to the licensing out and distribution of products in the Group's portfolio. In the first quarter 2019 it refers mainly to agreements for the commercialization of the lercanidipine‐enalapril fixed combination (€ 0.4 million), lercanidipine (€ 0.3 million), pitavastatin (€ 0.3 million), silodosin (€ 0.3 million) and Cystadrops® (cysteamine hydrochloride) (€ 0.2 million).

4. OPERATING EXPENSES

Overall operating expenses in the first quarter 2019 are € 257.0 million, an increase as compared to the € 246.0 million in the same period of the preceding year and are analyzed by function as follows:

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
Cost of sales 116,466 109,288 7,178
Selling expenses 94,563 91,687 2,876
Research and development expenses 29,152 27,664 1,488
General and administration expenses 17,254 16,372 882
Other income (expense), net (455) 958 (1,413)
Total operating expenses 256,980 245,969 11,011

Research and development expenses include the amortization of intangible assets, classified as licenses,

brands and patents, referable to acquired products for an overall amount of € 11.9 million.

Other income (expense) comprises non‐recurring events, operations and matters which are not often repeated in the ordinary course of business.

Total operating expenses are analyzed by nature as follows:

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
Raw material consumption 91,776 85,114 6,662
Payroll cost 63,270 59,212 4,058
Other employee costs 9,320 10,683 (1,363)
Variable sales expenses 19,741 17,570 2,171
Depreciation and amortization 17,929 13,842 4,087
Utilities and consumables 8,232 7,303 929
Other expenses 46,712 52,245 (5,533)
Total operating expenses 256,980 245,969 11,011

Personnel remuneration includes a cost for stock options of € 1.8 million in the first quarter of 2019 and € 0.7 million in the same period of the preceding year.

Depreciation charges are € 5.9 million, up by € 2.5 million compared to the first quarter of 2018, due almost entirely to the application of the new accounting principle IFRS 16 (see Note 2). Amortization charges are € 12.0 million, an increase of € 1.6 million over the same period of the preceding year.

5. FINANCIAL INCOME AND EXPENSE

In the first quarter of 2019 and in the same period of 2018 financial items record a net expense of € 4.0 million and € 4.9 million respectively and are comprised as follows:

€ (thousands) First quarter
2019
First quarter
2018
Change
2019/2018
Currency exchange (gains) losses (373) 743 (1,116)
Interest expense on loans 3,224 3,255 (31)
Net interest (income) expense on short‐term
financial position 870 803 67
Interest cost on leases (see Note 2) 221 221
Interest cost in respect of defined benefit plans 49 55 (6)
Total financial income (expense), net 3,991 4,856 (865)

6. PROPERTY, PLANT AND EQUIPMENT

The composition and variation of property, plant and equipment and the effect of the first time application of the new accounting principle IFRS 16 (see Note 2) are shown in the following table:

€ (thousands) Land &
buildings
Plant &
machinery
Other
equipment
Advances/
construction
in progress
Total
Cost
Balance at 31 December 2018 77,204 227,870 68,033 14,751 387,858
First time application IFRS 16 14,214 420 10,383 0 25,017
Balance at 31 January 2019 91,418 228,290 78,416 14,751 412,875
Additions 80 331 1,765 2,383 4,559
Disposals 0 (1) (500) (473) (974)
Other changes (975) 1,211 1,429 (2,587) (922)
Balance at 31 March 2019 90,523 229,831 81,110 14,074 415,538
Accumulated depreciation
Balance at 31 December 2018 43,767 186,365 54,144 0 284,276
Depreciation for the period 1,434 1,966 2,470 0 5,870
Disposals 0 (1) (504) 0 (505)
Other changes (249) (96) 296 0 (49)
Balance at 31 March 2019 44,952 188,234 56,406 0 289,592
Carrying amount at
31 March 2019 45,571 41,597 24,704 14,074 125,946
31 December 2018 33,437 41,505 13,889 14,751 103,582

The additions during the period are € 4.6 million and refer to investments in the Italian plants and in the headquarters building for an amount of € 2.6 million.

The conversion into euros of the tangible assets booked in different currencies gives rise to a net decrease of € 0.9 million as compared to 31 December 2018, almost entirely attributable to the devaluation of the Turkish lira.

7. INTANGIBLE ASSETS

The composition and variation of intangible assets are shown in the following table:

€ (thousands) Patent rights and
marketing
authorizations
Distribution, license,
trademark and similar
rights
Other Advance
payments
Total
Cost
Balance at 31 December 2018 582,461 413,510 18,948 30,567 1,045,486
Additions 0 22,600 2,308 812 25,720
Disposals 0 (265) 0 0 (265)
Other changes 3,782 (1,964) 2,800 (410) 4,208
Balance at 31 March 2019 586,243 433,881 24,056 30,969 1,075,149
Accumulated amortization
Balance at 31 December 2018 187,418 168,918 16,688 0 373,024
Amortization for the period 6,629 5,316 114 0 12,059
Disposals 0 (265) 0 0 (265)
Other changes 1,292 (2,442) 2,615 0 1,465
Balance at 31 March 2019 195,339 171,527 19,417 0 386,283
Carrying amount at
31 March 2019 390,904 262,354 4,639 30,969 688,866
31 December 2018 395,043 244,592 2,260 30,567 672,462

Increases during the period refer mainly to the up‐front payment of \$ 25 million to Aegerion Pharmaceuticals Inc. as per the license agreement for the exclusive commercialization rights in Japan for Juxtapid®, a product indicated for patients with homozygous familial hypercholesterolemia.

The conversion into euros of the intangible assets booked in different currencies gives rise to a net increase of € 2.7 million as compared to 31 December 2018, mainly attributable to the revaluation of the Russian ruble (increase of € 1.7 million) and the U.S. dollar (increase of € 1.3 million).

8. GOODWILL

Net goodwill at 31 March 2019 amounts to € 579.2 million, a decrease of € 0.3 million as compared to that at 31 December 2018, and is attributed to the operational areas, which represent the same number of cash generating units:

  • France: € 45.8 million;
  • Russia: € 27.0 million;
  • Germany: € 48.8 million;
  • Portugal: € 32.8 million;
  • Treatments for rare diseases business: € 110.6 million;
  • Turkey: € 39.2 million;
  • Czech Republic: € 13.7 million;
  • Romania: € 0.2 million;
  • Poland: € 15.3 million;
  • Spain: € 58.1 million;
  • Tunisia: € 16.0 million;

  • Italy: € 133.2 million;
  • Switzerland: € 8.3 million.

Goodwill related to acquisitions made in countries outside the European Monetary Union is calculated in local currency and converted into euros at the period‐end exchange rate. Conversion at 31 March 2019 resulted in an overall net decrease of € 0.3 million, compared to that at 31 December 2018, to be attributed to the acquisitions in Turkey (decrease of € 1.8 million), Czech Republic (decrease of € 0.1 million), Russia (increase of € 1.3 million), Tunisia (decrease of € 0.2 million), and Switzerland (increase of € 0.1 million).

In compliance with IFRS 3 goodwill is not systematically amortized. Instead, it is tested for impairment on an annual basis or more frequently if specific events or circumstances indicate a possible loss of value. During the first quarter of 2019 no events or circumstances arose to indicate possible value loss related to any of the abovementioned items.

9. OTHER INVESTMENTS

At 31 March 2019 other investments amount to € 21.5 million, an increase of € 0.7 million compared to those at 31 December 2018.

The main investment is that made in the U.K. company PureTech Health plc, specialized in investment in start‐ up companies dedicated to innovative therapies, medical devices and new research technologies. Starting 19 June 2015 the shares of the company were admitted to trading on the London Stock Exchange. At 31 March 2019 the overall fair value of the 9.554.140 shares held is of € 18.3 million. The € 0.3 million increase in value compared to that at 31 December 2018 is recognized directly in equity, net of the relative tax effect, and shown on the statement of comprehensive income.

This account also comprises € 3.1 million regarding an investment made during 2012 in Erytech Pharma S.A., a late development stage French biopharmaceutical company focused on orphan oncology and rare diseases. The investment, originally structured as a non‐interest bearing loan, was converted into 431,034 shares of the company in May 2013. As compared to 31 December 2018 the value of the investment was increased by € 0.4 million to bring it in line with its fair value. This amount, net of its tax effect, is recognized directly in equity and shown on the statement of comprehensive income.

10. DEFERRED TAX ASSETS AND LIABILITIES

At 31 March 2019 deferred tax assets are € 79.4 million, a net decrease of € 1.9 million compared to those at 31 December 2018. Deferred tax liabilities are € 45.8 million, substantially unchanged compared to those at 31 December 2018.

11. SHAREHOLDERS' EQUITY

Shareholders' Equity at 31 March 2019 is € 1,067.3 million, an increase of € 103.7 million compared to that at 31 December 2018 for the following reasons:

  • net income for the period (increase of € 92.1 million);
  • cost of stock option plans set‐off directly in equity (increase of € 1.8 million);
  • disposal of 405,500 own shares in treasury stock to service the stock option plans (increase of € 4.8 million);

  • change in the value of cross currency swaps, the underlying loans and interest rate swaps set‐off directly in equity, net of the relative tax effect (decrease of € 0.4 million);
  • application of IAS/IFRS (increase of € 0.6 million), almost entirely due to the change in fair value of the holdings in PureTech Health plc and in Erytech Pharma S.A., net of the tax effect;
  • translation adjustments (increase of € 4.8 million);

The Italian subsidiary of Orphan Europe is 99% owned giving rise to a minority interest of € 205.0 thousand.

As at 31 March 2019 the Company has three stock option plans in favor of certain group employees in place, the 2010‐2013 plan, under which options were granted on 9 February 2011, on 8 May 2012, on 17 April 2013 and on 30 October 2013, the 2014‐2018, plan under which options were granted on 29 July 2014 and on 13 April 2016 and the 2018‐2022 plan, under which options were granted on 3 August 2018. The strike price of the options is the average of the parent company's listed share price during the 30 days prior to the grant date. Stock options are vested over a period of five years and those 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. Stock options outstanding at 31 March 2019 are analyzed in the following table.

Strike price
(€)
Options
outstanding
at 1.1.2019
Options
granted
during 2019
Options
exercised
during 2019
Options
cancelled
or expired
Options
outstanding at
31.3.2019
Date of grant
9 February 2011 6.7505 73,500 (27,500) 46,000
8 May 2012 5.3070 427,500 (105,000) 322,500
17 April 2013 7.1600 25,000 25,000
30 October 2013 8.9300 15,000 15,000
29 July 2014 12.2900 2,171,000 (202,500) 1,968,500
13 April 2016 21.9300 2,961,500 (70,500) (67,500) 2,823,500
3 August 2018 30.7300 4,818,000 4,818,000
Total 10,491,500 (405,500) (67.500) 10,018,500

At 31 March 2019, 4,748,071 own shares are held as treasury stock, a reduction of 405,500 shares as compared to those at 31 December 2018. The change is to be attributed to the disposal of 405,500 shares for an overall value of € 4.8 million to service the exercise of stock options issued under the stock option plans. The overall purchase cost of the shares held in treasury stock is € 134.1 million with an average unit price of € 28.25.

12. LOANS

At 31 March 2019 medium and long‐term loans are € 724.6 million, a net decrease of € 46.6 million compared to those at 31 December 2018.

Loans include the liability, determined by the application of the new accounting principle IFRS 16, that represents the obligation of making the payments provided for in the existing lease contracts (see Note 2). The value of this liability at the date of first time application of the principle is of € 25.0 million, while new contracts entered into during the period account for an additional liability of € 0.7 million.

Reimbursements during the first quarter 2019 amount to € 73.8 million, of which € 61.3 million are due to the early repayment of the privately placed notes issued by Recordati Rare Diseases on 13 June 2013 for a total of \$ 70 million, following the acquisition of FIMEI S.p.A. (shareholder of the Parent) by a Consortium of investment funds controlled by CVC Capital Partners.

The conversion of loans in foreign currency gave rise to an increase of € 1.5 million compared to those at 31 December 2018.

The main long‐term loans outstanding are:

  • a) A loan agreement stipulated with Mediobanca by the Parent in November 2018 for an amount of € 150.0 million. The main terms and conditions provide for variable interest rate fixed at the six months' Euribor plus a spread of 130 basis points with semi‐annual repayments of capital from 23 November 2020 through 22 November 2023. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 1.619%. The measurement at fair value at 31 March 2019 of the swap generated a liability of € 2.3 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

  • b) A loan of € 4.3 million granted to the Parent in July 2018 by the Banca del Mezzogiorno‐Mediocredito Centrale to fund investments in research and development, of which € 3.9 million at a reduced fixed interest rate of 0.50% to be repaid in six semi‐annual installments starting 30 June 2019 through 31 December 2021, and € 0.4 million at a variable interest rate equal to the 6 months' Euribor plus a spread of 220 basis points, to be repaid in two installments on 30 June and 31 December 2021.
  • c) A loan agreement with Banca Passadore undersigned by the Parent in November 2017 for an amount of € 15.0 million, disbursed net of up‐front commissions of 0.05%. The main terms and conditions provide for variable interest rate fixed at the three months' Euribor plus a spread of 65 basis points with quarterly payments of interest and a duration of 5 years with annual repayments of capital from November 2020 through November 2022. The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

d) A loan agreement with Intesa Sanpaolo undersigned by the Parent in October 2017 for an amount of € 75.0 million, disbursed net of up‐front commissions of 0.30%. The main terms and conditions provide for variable interest rate fixed at the six months' Euribor plus a spread of 95 basis points, semi‐annual payments of interest and a duration of 8 years with semi‐annual repayments of capital from June 2019 through October 2025. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 1.305%. The measurement at fair value at 31 March 2019 of the swap generated a liability of € 1.1 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:

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

The above conditions were amply fulfilled during the period.

  • e) A loan agreement with UniCredit undersigned by the Parent in September 2017 for an amount of € 50.0 million, disbursed net of up‐front commissions of 0.15%. The main terms and conditions provide for variable interest rate fixed at the six months Euribor plus a spread of 55 basis points with semi‐annual payments of interest and the repayment of capital on 29 September 2021. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 0.698%. The measurement at fair value at 31 March 2019 of the swap generated a liability of € 0.4 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

  • f) A loan agreement with UBI Banca undersigned by the Parent in September 2017 for an amount of € 50.0 million, disbursed net of up‐front commissions of 0.10%. The main terms and conditions provide for variable interest rate fixed at the six months Euribor plus a spread of 50 basis points with semi‐annual payments of interest and the repayment of capital on 7 September 2022. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 0.714%. The measurement at fair value at 31 March 2019 of the swap generated a liability of € 0.6 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

  • g) A loan agreement with Mediobanca undersigned by the Parent in July 2017 for an amount of € 75.0 million. The main terms and conditions provide for variable interest rate fixed at the six months Euribor plus a spread of 95 basis points and a duration of 7 years with annual repayments of capital from July 2018 through July 2024. The debt outstanding at 31 December 2018 is of € 64.5 million. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 1.29%. The measurement at fair value at 31 March 2019 of the swap generated a liability of € 0.8 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

  • h) Privately placed guaranteed senior notes by the Parent in May 2017 for an overall amount of € 125.0 million at 2.07% fixed interest rate with repayment in annual instalments starting on 31 May 2025 through 31 May 2032. The note purchase agreement covering the notes includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

  • i) A loan agreement with Banca Nazionale del Lavoro undersigned by the Parent company in December 2016 for an amount of € 25.0 million, disbursed net of expenses and commissions of € 0.1 million. The main terms and conditions provide for variable interest rate fixed at the six months Euribor plus a spread of 40 basis points and a duration of 4 years with semi‐annual repayments of capital from March 2019 through September 2020. The debt outstanding at 31 March 2019 is of € 18.7 million. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 0.41%. The measurement at fair value at 31 March 2019 of the swap generated a slight liability which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions are amply fulfilled.

  • j) A loan agreement with Intesa Sanpaolo undersigned by the Parent company in December 2016 for an amount of € 25.0 million, disbursed net of expenses and commissions of € 0.1 million. The main terms and conditions provide for variable interest rate fixed at the six months Euribor plus a spread of 60 basis points and a duration of 5 years with semi‐annual repayments of capital from June 2019 through December 2021. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate of 0.68%. The measurement at fair value at 31 March 2019 of the swap generated a liability of € 0.1 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are:
    • the ratio of consolidated net debt to EBITDA (for a period of twelve consecutive months) must be less than 3.00 to 1.00;
    • the ratio of consolidated operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions are amply fulfilled.

k) A loan agreement with UniCredit undersigned by the Parent company in May 2015 for an amount of € 50.0 million. The main terms and conditions provide for variable interest rate fixed at the six months Euribor plus a spread of 80 basis points and a duration of 5 years with semi‐annual repayments of capital from

November 2015 through May 2020. The debt outstanding at 31 March 2019 is of € 14.9 million. The loan is partly covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges on a portion of the debt from variable to a fixed rate of 1.734%. The measurement at fair value at 31 March 2019 of the swap covering € 8.3 million generated a liability of € 0.1 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are:

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

The above conditions are amply fulfilled.

  • l) A loan agreement with ING Bank for an amount of € 30.0 million, originally undersigned by the Parent company on 8 January 2014, was re‐negotiated on 12 June 2015 with only the interest rate being changed. Main terms are: variable interest rate equivalent to the six months' Euribor plus a spread of 85 basis points (as opposed to the 190 basis points in the previous agreement), and reimbursement of principal at the end of every six months starting July 2016 through January 2020. The debt outstanding at 31 March 2019 is of € 7.5 million. The loan was simultaneously covered with an interest rate swap qualifying as a cash flow hedge transforming the interest payable on the entire debt to a fixed interest rate of 1.913% following the above mentioned re‐negotiation. The fair value measurement of the swap at 31 March 2019 generated a liability of € 0.1 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The ING Bank loan agreement contains covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • 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 operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions are amply fulfilled.

  • m) A loan agreement with IFC‐World Bank undersigned by the subsidiary Recordati Ilaç on 16 October 2014 for an amount of 71.6 million Turkish lira to finance the construction of a new production plant. Main terms are: variable interest rate equivalent to the three months' trlibor plus a spread of 162 basis points, 8‐year duration and reimbursement of principal at the end of every three months starting November 2016 through August 2022. The value in euros of the outstanding loan at 31 March 2019 is of € 6.4 million, resulting in a reduction of the liability by € 0.8 million as compared to that at 31 December 2018, of which € 0.3 million was due to the devaluation of the Turkish lira at the date of consolidation. The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are:
    • 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 consolidated operating income to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled.

n) Privately placed guaranteed senior notes by the Parent company on 30 September 2014 for an amount of \$ 75 million in two tranches: \$ 50 million at a fixed interest rate of 4,28% to be reimbursed bi‐annually as from 30 March 2022 through 30 September 2026, and \$ 25 million at a fixed interest rate of 4.51% to be

reimbursed bi‐annually as from 30 March 2023 through 30 September 2029. The conversion of the loan into euros at 31 March 2019 resulted in an increase of the liability by € 1.3 million as compared to that at 31 December 2018 due to the revaluation of the U.S. dollar. The loan was simultaneously covered with two currency rate swaps transforming the overall debt to € 56.0 million, of which € 37.3 million at a fixed interest rate of 2.895% on the 12‐year tranche and € 18.7 million at a fixed interest rate of 3.15% on the 15‐year tranche. At 31 March 2019 the measurement at fair value of the hedging instruments generated an overall positive amount of € 8.0 million recognized directly to equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current assets (see Note 17).

The note purchase agreement covering the senior guaranteed notes issued by Recordati S.p.A. includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:

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

The above conditions were amply fulfilled during the period.

  • o) A loan agreement with Centrobanca undersigned by the Parent company on 30 November 2010 to fund a three‐year research and investment program. The loan, for which Centrobanca received funding from the European Investment Bank, amounts to € 75.0 million of which € 30.0 million were cashed in during 2010 and € 45.0 million in the first quarter of 2011, net of the € 0.3 million expenses. The main terms and conditions provide for a variable interest rate and a duration of 12 years with semi‐annual repayments of capital from June 2012 through December 2022. At 31 March 2019 the outstanding amount of the loan is € 27.2 million. During the month of June 2012 interest on the whole loan was covered with an interest rate swap qualifying as a cash flow hedge. The current interest rate on the loan is 2.575%. The measurement at fair value of the hedging instrument at 31 March 2019 generated a liability of € 1.0 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 17). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants are the following:
    • the ratio of consolidated net debt to consolidated net 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 consolidated EBITDA to consolidated net interest expense (for a period of twelve consecutive months) must exceed 3.00 to 1.00.

The above conditions were amply fulfilled during the period.

13. STAFF LEAVING INDEMNITIES

The staff leaving indemnity fund at 31 March 2019 is of € 19.4 million and is measured as prescribed by IAS 19.

14. OTHER NON‐CURRENT LIABILITIES

Other non‐current liabilities at 31 March 2019 are € 3.3 million and refer entirely to the debt for the acquisition of a further 10% of the share capital of Opalia Pharma which, in line with the put and call options in the purchase agreement, is expected to be settled not before the next 12 months.

15. CURRENT ASSETS

Inventories are € 203.0 million, a reduction of € 3.1 million compared to those stated at 31 December 2018.

Trade receivables at 31 March 2019 are € 286.7 million, an increase of € 41.0 million compared to that at 31 December 2018 due to the increase in sales. Trade receivables are stated net of a € 13.9 million provision for doubtful accounts, a reduction of € 0.7 million compared to 31 December 2018, which reflects the collection risk connected with certain customers and geographic areas. Days sales outstanding are 65.

Other receivables, at € 29.1 million, decrease by € 9.3 million compared to those at 31 December 2018.

Other current assets are € 9.4 million and refer mainly to prepaid expenses.

16. CURRENT LIABILITIES

Trade payables, which include the accrual for invoices to be received, are € 139.2 million.

Other payables are € 88.4 million, an increase of € 2.8 million compared to those at 31 December 2018, and relate mainly to amounts owed to personnel and social security institutions. This account also includes:

  • € 5.6 million to be paid to the "Krankenkassen" (German health insurance) by Recordati Pharma GmbH;
  • € 6.2 million to be paid to U.S. health insurance institutions by Recordati Rare Diseases;
  • € 7.4 million to be paid to the Italian health authorities resulting from the 1.83% claw‐back applicable on the price to the public before VAT of pharmaceutical products reimbursed by the National Health Service and the pay‐back due in substitution for a 5% price reduction on selected products.

Tax payables are € 61.8 million, an increase of € 19.7 million compared to those at 31 December 2018.

Provisions are € 20.9 million, a reduction of € 0.5 million compared to those at 31 December 2018.

17. FAIR VALUE OF HEDGING DERIVATIVES (CASH FLOW HEDGE)

The cross currency swaps covering the cash flows related to the notes issued and privately placed on 30 September 2014, for an amount of \$ 75 million, measured at fair value at 31 March 2019 give rise to a € 8.0 million asset recognized under current assets as 'Fair value of hedging derivatives (cash flow hedge)'. This amounts represents the potential benefit of a lower value in euros of the future dollar denominated capital and interest flows, in view of the revaluation of the foreign currency subsequent to the moment in which the loan and hedging instrument were negotiated. In particular, the change in fair value of the hedging instrument covering the \$ 50 million tranche of the loan, provided by Mediobanca, was positive for an amount of € 5.5 million, and that covering the \$ 25 million tranche of the loan, provided by UniCredit, yielded a € 2.5 million positive value change.

The measurement at fair value of the interest rate swaps covering the cash flows related to medium and long‐ term loans gave rise to a net € 6.5 million liability at 31 March 2019 recognized under current liabilities as 'Fair value of hedging derivatives (cash flow hedge)'. This amount represents the unrealized opportunity of paying the current expected future rates instead of the rates agreed. The amount refers to the interest rate swaps to cover the interest rate risk associated with the loans granted by Mediobanca (€ 3.1 million), Intesa Sanpaolo (€ 1.2 million), Centrobanca (€ 1.0 million), UBI Banca (€ 0.6 million), UniCredit (€ 0.5 million) and ING Bank (€ 0.1 million).

At 31 March 2019 the fair value of the cross currency swaps provided by Unicredit in November 2016, following two loan agreements undersigned by the U.S. company Recordati Rare Diseases and the Parent for a nominal total of \$ 70 million, determined a liability of € 2.8 million.

18. SHORT‐TERM FINANCIAL INVESTMENTS, CASH AND CASH EQUIVALENTS

Short term financial investments, cash and cash equivalents at 31 March 2019 are € 184.7 million, a reduction of € 13.4 million compared to those at 31 December 2018. They are mostly denominated in euros, U.S. dollars and Pounds Sterling and comprise mainly current accounts and short‐term deposits.

19. BANK OVERDRAFTS AND SHORT‐TERM LOANS

Bank overdrafts and short‐term loans are € 23.8 million at 31 March 2019 and are comprised mainly of temporary use of lines of credit, current account overdrafts and interest accrued on existing loans. The € 6.9 million increase compared to 31 December 2018 is to be attributed mainly to use of lines of credit by foreign Group subsidiaries.

At 31 March 2019 the revolving line of credit obtained in July 2017 by Recordati Ilaç, the subsidiary in Turkey, for a maximum amount of 40 million Turkish lira was not drawn down. This short‐term financing instrument, which has 24 months' maximum duration, provides flexibility by combining the fact that it's non‐revocable with the variability of the draw‐downs based on specific financial needs. The agreement contains financial covenants in line with those already in place for other loans.

20. OPERATING SEGMENTS

The financial information reported by line of business and by geographical area, in compliance with IFRS 8 – Operating segments, is prepared using the same accounting principles and reporting standards used for the preparation and disclosure of the Group consolidated financial statements. Following the acquisition of Orphan Europe two main business segments can be identified, the specialty and primary care segment and the rare diseases segment.

The following table shows financial information for these two business segments as at 31 March 2019 and includes comparative data.

€ (thousands) Specialty &
primary care
segment*
Rare diseases
segment
Non‐allocated Consolidated
accounts
First quarter 2019
Revenues 326,834 56,156 382,990
Expenses (228,061) (28,919) (256,980)
Operating income 98,773 27,237 126,010
EBITDA(1) 114,680 29,259 143,939
First quarter 2018
Revenues 311,672 54,828 366,500
Expenses (216,886) (29,083) (245,969)
Operating income 94,786 25,745 120,531
EBITDA(1) 107,114 27,259 134,373

* Includes the pharmaceutical chemicals operations

(1) Operating income before depreciation, amortization and write down of both tangible and intangible assets.

€ (thousands) Specialty &
primary care
segment*
Rare diseases
segment
Non‐allocated
**
Consolidated
accounts
31 March 2019
Non‐current assets 1,222,615 256,833 21,491 1,500,939
Inventories 180,351 22,636 202,987
Trade receivables 239,972 46,771 286,743
Other current assets 31,969 6,566 7,965 46,500
Short‐term investments, cash and
cash equivalents 184,677 184,677
Total assets 1,674,907 332,806 214,133 2,221,846
Non‐current liabilities 65,511 2,978 646,680 715,169
Current liabilities 280,088 48,261 111,014 439,363
Total liabilities 345,599 51,239 757,694 1,154,532
Net capital employed 1,329,308 281,567
31 December 2018
Non‐current assets 1,216,263 226,466 20,772 1,463,501
Inventories 188,988 17,096 206,084
Trade receivables 206,389 39,353 245,742
Other current assets 38,371 5,284 6,414 50,069
Short‐term investments, cash and
cash equivalents 198,036 198,036
Total assets 1,650,011 288,199 225,222 2,163,432
Non‐current liabilities 65,805 2,652 640,647 709,104
Current liabilities 264,813 68,694 157,235 490,742
Total liabilities 330,618 71,346 797,882 1,199,846
Net capital employed 1,319,393 216,853

* Includes the pharmaceutical chemicals operations.

** Non‐allocated amounts include: other equity investments, short‐term investments, cash and cash equivalents, loans, hedging instruments, bank overdrafts and short‐term loans.

The pharmaceutical chemicals operations are considered part of the Specialty and Primary Care segment as they are prevalently dedicated to the production of active ingredients for this business, both from a strategic and organizational point of view.

21. LITIGATION AND CONTINGENT LIABILITIES

In December 2015, the Italian Tax Police (Guardia di Finanza) notified the Company of their intention to commence a general income tax inspection covering the years 2009 through 2014 involving the Group company in Ireland, Recordati Ireland Ltd. The declared intention of the inspection was to evaluate the operational context of the foreign company in order to verify whether said company is in reality only formally localized abroad but is substantially managed/administered from Italy. On 28th February 2017 the Italian Tax Police (Guardia di Finanza) prescribed the extension of the income tax inspection to include the year 2015. After having analysed the documents and completed the investigation process, the Italian Tax Police finally revealed to Recordati Ireland Ltd., on 6th September 2017, their reasons for considering the Irish company subject to tax in Italy for corporate tax purposes in the reference period, resulting in an assessment of taxes allegedly owed to Italy, in the amount of € 109,4 million, against taxes of € 51,8 million already paid in Ireland. Recordati lreland Ltd. filed its comments and observations on the findings reported in the above mentioned

Tax Audits Reports within the legal deadlines. During 2018, the Lombardy Regional Directorate of the Italian Revenue Agency, in charge of Recordati S.p.A, reviewed the claims raised in the aforementioned audit report and carried out an in‐depth analysis on the relations between Recordati S.p.A and the Irish subsidiary in the tax periods from 2009 to 2015. Following that analysis, the Agency concluded ‐ confirming the soundness of the Company's thesis ‐ that, in the tax periods from 2009 to 2015, the Irish company cannot be deemed a fictitious foreign resident company. However, according to the Agency, part of the profit made by the Irish subsidiary in the aforementioned financial years was attributable to Recordati S.p.A, due to an alleged management support provided by the Italian parent company to the Irish subsidiary. Based on those assumptions, the Agency made a proposal of tax settlement for Ires and Irap purposes with respect to the tax years from 2009 to 2015, wherein it required the payment of further taxes equal to a total of € 21.0 million, over € 4.9 million of interest and € 2.5 million for penalties, which Recordati S.p.A., with a view to avoid litigation, accepted and paid in November 2018. The Company will apply the same criteria to the subsequent years, 2016 and 2017, with the intention to settle the tax claim in 2019 for which the related provision has been recognized in the 2018 income statement for an amount of around € 5 million.

22. RELATED PARTY TRANSACTIONS

Tax liabilities shown in the consolidated balance sheet at 31 March 2019 include those payable to the controlling company FIMEI S.p.A. for an amount of € 14.4 million. This amount refers to tax liabilities computed by the parent Recordati S.p.A. based on estimated taxable income and transferred to the controlling company consequent to the participation in a tax consolidation grouping under tax laws in Italy.

Except for the above, to our knowledge, no transactions or contracts have been entered into with related parties that can be considered significant, in value or conditions, or which could in any way materially affect the accounts.

23. SUBSEQUENT EVENTS

No significant events occurred subsequent to 31 March 2019.

SUBSIDIARIES INCLUDED IN THE CONSOLIDATED ACCOUNTS AT 31 MARCH 2019

ATTACHMENT 1.

Consolidated Companies Head Office Share Capital Currency Consolidation
Method
RECORDATI S.P.A.
Development, production, marketing and sales of pharmaceuticals and
pharmaceutical chemicals
Italy 26,140,644.50 EUR Line‐by‐line
INNOVA PHARMA S.P.A.
Marketing and sales of pharmaceuticals
Italy 1,920,000.00 EUR Line‐by‐line
CASEN RECORDATI S.L.
Development, production, marketing and sales of pharmaceuticals
Spain 238,966,000.00 EUR Line‐by‐line
BOUCHARA RECORDATI S.A.S.
Development, production, marketing and sales of pharmaceuticals
France 4,600,000.00 EUR Line‐by‐line
RECORDATI RARE DISEASES COMERCIO DE MEDICAMENTOS LTDA
Holds pharmaceutical marketing rights in Brazil
Brazil 166.00 BRL Line‐by‐line
RECORDATI RARE DISEASES INC.
Development, production, marketing and sales of pharmaceuticals
U.S.A. 11,979,138.00 USD Line‐by‐line
RECORDATI IRELAND LTD
Development, production, marketing and sales of pharmaceuticals
Ireland 200,000.00 EUR Line‐by‐line
LABORATOIRES BOUCHARA RECORDATI S.A.S.
Development, production, marketing and sales of pharmaceuticals
France 14,000,000.00 EUR Line‐by‐line
RECORDATI PHARMA GmbH
Marketing and sales of pharmaceuticals
Germany 600,000.00 EUR Line‐by‐line
RECORDATI PHARMACEUTICALS LTD
Marketing and sales of pharmaceuticals
United Kingdom 15,000,000.00 GBP Line‐by‐line
RECORDATI HELLAS PHARMACEUTICALS S.A.
Marketing and sales of pharmaceuticals
Greece 10,050,000.00 EUR Line‐by‐line
JABA RECORDATI S.A.
Marketing and sales of pharmaceuticals
Portugal 2,000,000.00 EUR Line‐by‐line
JABAFARMA PRODUTOS FARMACÊUTICOS S.A.
Marketing of pharmaceuticals
Portugal 50,000.00 EUR Line‐by‐line
BONAFARMA PRODUTOS FARMACÊUTICOS S.A.
Marketing of pharmaceuticals
Portugal 50,000.00 EUR Line‐by‐line
RECORDATI ORPHAN DRUGS S.A.S.
Holding company
France 57,000,000.00 EUR Line‐by‐line
ORPHAN EUROPE SWITZERLAND GmbH
Marketing and sales of pharmaceuticals
Switzerland 20,000.00 CHF Line‐by‐line
ORPHAN EUROPE MIDDLE EAST FZ LLC
Marketing and sales of pharmaceuticals
United Arab
Emirates
100,000.00 AED Line‐by‐line
RECORDATI AB
Marketing and sales of pharmaceuticals
Sweden 100,000.00 SEK Line‐by‐line
ORPHAN EUROPE S.à R.L.
Development, production, marketing and sales of pharmaceuticals
France 320,000.00 EUR Line‐by‐line
ORPHAN EUROPE UNITED KINGDOM LTD
Marketing and sales of pharmaceuticals
United Kingdom 50,000.00 GBP Line‐by‐line
ORPHAN EUROPE GERMANY GmbH
Marketing and sales of pharmaceuticals
Germany 25,600.00 EUR Line‐by‐line
ORPHAN EUROPE SPAIN S.L.
Marketing and sales of pharmaceuticals
Spain 1,775,065.49 EUR Line‐by‐line
ORPHAN EUROPE ITALY S.R.L.
Marketing and sales of pharmaceuticals
Italy 40,000.00 EUR Line‐by‐line
RECORDATI BVBA
Marketing and sales of pharmaceuticals
Belgium 18,600.00 EUR Line‐by‐line

Consolidated Companies Head Office Share Capital Currency Consolidation
Method
FIC MEDICAL S.à R.L.
Marketing of pharmaceuticals
France 173,700.00 EUR Line‐by‐line
HERBACOS RECORDATI s.r.o.
Development, production, marketing and sales of pharmaceuticals
Czech Republic 25,600,000.00 CZK Line‐by‐line
RECORDATI SK s.r.o.
Marketing and sales of pharmaceuticals
Slovakia 33,193.92 EUR Line‐by‐line
RUSFIC LLC
Marketing and sales of pharmaceuticals
Russian Federation 3,560,000.00 RUB Line‐by‐line
RECOFARMA ILAÇ Ve Hammaddeleri Sanayi Ve Ticaret L.Ş.
Marketing of pharmaceuticals
Turkey 10,000.00 TRY Line‐by‐line
RECORDATI ROMÂNIA S.R.L.
Marketing and sales of pharmaceuticals
Romania 5,000,000.00 RON Line‐by‐line
RECORDATI İLAÇ Sanayi Ve Ticaret A.Ş.
Development, production, marketing and sales of pharmaceuticals
Turkey 180,000,000.00 TRY Line‐by‐line
RECORDATI POLSKA Sp. z o.o.
Marketing and sales of pharmaceuticals
Poland 4,500,000.00 PLN Line‐by‐line
ACCENT LLC
Holds pharmaceutical marketing rights
Russian Federation 20,000.00 RUB Line‐by‐line
RECORDATI UKRAINE LLC
Marketing of pharmaceuticals
Ukraine 1,031,896.30 UAH Line‐by‐line
CASEN RECORDATI PORTUGAL Unipessoal Lda
Marketing and sales of pharmaceuticals
Portugal 100,000.00 EUR Line‐by‐line
OPALIA PHARMA S.A.
Development, production, marketing and sales of pharmaceuticals
Tunisia 9,656,000.00 TND Line‐by‐line
OPALIA RECORDATI S.à R.L.
Marketing of pharmaceuticals
Tunisia 20,000.00 TND Line‐by‐line
RECORDATI RARE DISEASES S.A. DE C.V.
Marketing of pharmaceuticals
Mexico 16,250,000.00 MXN Line‐by‐line
RECORDATI RARE DISEASES COLOMBIA S.A.S
Marketing of pharmaceuticals
Colombia 150,000,000.00 COP Line‐by‐line
ITALCHIMICI S.p.A.
Marketing of pharmaceuticals
Italy 7,646,000.00 EUR Line‐by‐line
RECORDATI AG
Marketing of pharmaceuticals
Switzerland 3,000,000.00 CHF Line‐by‐line
PRO FARMA GmbH
Marketing of pharmaceuticals
Austria 35,000.00 EUR Line‐by‐line
RECORDATI RARE DISEASES CANADA Inc.
Marketing of pharmaceuticals
Canada 350,000.00 CAD Line‐by‐line
RECORDATI RARE DISEASES JAPAN K.K. (1)
Marketing of pharmaceuticals
Japan 10,000,000.00 JPY Line‐by‐line
NATURAL POINT S.r.l. (2)
Marketing of pharmaceuticals
Italy 10,400.00 EUR Line‐by‐line
RECORDATI RARE DISEASES AUSTRALIA Pty Ltd (1)
Marketing of pharmaceuticals
Australia 200,000.00 AUD Line‐by‐line
TONIPHARM S.A.S. (2)
Marketing of pharmaceuticals
France 257,700.00 EUR Line‐by‐line
RECORDATI BULGARIA Ltd (3)
Marketing of pharmaceuticals
Bulgaria 50,000.00 BGN Line‐by‐line

(1) Established in 2018

(2) Acquired in 2018

(3) Established in 2019

PERCENTAGE OF OWNERSHIP
Consolidated companies Recordati
S.p.A.
(Parent)
Recordati
Pharma
GmbH
Bouchara
Recordati
S.A.S.
Casen
Recordati
S.L.
Recordati
Orphan
Drugs
S.A.S.
Orphan
Europe
S.à R.L.
Herbacos
Recordati
s.r.o.
Recordati
Ilaç A.Ş.
Opalia
Pharma
S.A.
Recordati
AG
Total
INNOVA PHARMA S.P.A. 100.00 100.00
CASEN RECORDATI S.L. 100.00 100.00
BOUCHARA RECORDATI S.A.S. 100.00 100.00
RECORDATI RARE DISEASES
COMERCIO DE MEDICAMENTOS
LTDA
99.398 0.602 100.00
RECORDATI RARE DISEASES INC. 100.00 100.00
RECORDATI IRELAND LTD 100.00 100.00
LABORATOIRES BOUCHARA
RECORDATI S.A.S.
100.00 100.00
RECORDATI PHARMA GmbH 55.00 45.00 100.00
RECORDATI PHARMACEUTICALS
LTD
100.00 100.00
RECORDATI HELLAS
PHARMACEUTICALS S.A.
100.00 100.00
JABA RECORDATI S.A. 100.00 100.00
JABAFARMA PRODUTOS
FARMACÊUTICOS S.A.
100.00 100.00
BONAFARMA PRODUTOS
FARMACÊUTICOS S.A.
100.00 100.00
RECORDATI ORPHAN DRUGS
S.A.S.
90.00 10.00 100.00
ORPHAN EUROPE
SWITZERLAND GmbH
100.00 100.00
ORPHAN EUROPE MIDDLE EAST
FZ LLC
100.00 100.00
RECORDATI AB 100.00 100.00
ORPHAN EUROPE S.à R.L. 100.00 100.00
ORPHAN EUROPE UNITED
KINGDOM LTD
100.00 100.00
ORPHAN EUROPE GERMANY
GmbH
100.00 100.00
ORPHAN EUROPE SPAIN S.L. 100.00 100.00
ORPHAN EUROPE ITALY S.R.L. 99.00 99.00
RECORDATI BVBA 99.46 0.54 100.00
FIC MEDICAL S.à R.L. 100.00 100.00
HERBACOS RECORDATI s.r.o. 100.00 100.00

PERCENTAGE OF OWNERSHIP
Consolidated companies Recordati
S.p.A.
(Parent)
Recordati
Pharma
GmbH
Bouchara
Recordati
S.A.S.
Casen
Recordati
S.L.
Recordati
Orphan
Drugs
S.A.S.
Orphan
Europe
S.à R.L.
Herbacos
Recordati
s.r.o.
Recordati
Ilaç A.Ş.
Opalia
Pharma
S.A.
Recordati
AG
Total
RECORDATI SK s.r.o. 100.00 100.00
RUSFIC LLC 100.00 100.00
RECOFARMA ILAÇ Ve
Hammaddeleri Sanayi Ve
Ticaret L.Ş.
100.00 100.00
RECORDATI ROMÂNIA S.R.L. 100.00 100.00
RECORDATI İLAÇ Sanayi Ve
Ticaret A.Ş.
100.00 100.00
RECORDATI POLSKA
Sp. z o.o
100.00 100.00
ACCENT LLC 100.00 100.00
RECORDATI UKRAINE LLC 0.01 99.99 100.00
CASEN RECORDATI PORTUGAL
Unipessoal Lda
100.00 100.00
OPALIA PHARMA S.A. 90.00 90.00
OPALIA RECORDATI
S.à R.L.
1.00 99.00 100.00
RECORDATI RARE DISEASES S.A.
DE C.V.
99.998 0.002 100.00
RECORDATI RARE DISEASES
COLOMBIA S.A.S.
100.00 100.00
ITALCHIMICI S.p.A. 100.00 100.00
RECORDATI AG 100.00 100.00
PRO FARMA GmbH 100.00 100.00
RECORDATI RARE DISEASES
CANADA Inc.
100.00 100.00
RECORDATI RARE DISEASES
JAPAN K.K.(1)
100.00 100.00
NATURAL POINT S.r.l.(2) 100.00 100.00
RECORDATI RARE DISEASES
AUSTRALIA Pty Ltd (1)
100.00 100.00
TONIPHARM S.A.S.(2) 100.00 100.00
RECORDATI BULGARIA Ltd (3) 100.00 100.00

(1) Established in 2018

(2) Acquired in 2018

(3) Established in 2019

DECLARATION BY THE MANAGER RESPONSIBLE FOR PREPARING THE COMPANY'S FINANCIAL REPORTS

The manager responsible for preparing the company's financial reports Fritz Squindo declares, pursuant to paragraph 2 of Article 154‐bis of the Consolidated Law on Finance, that the accounting information contained in this report corresponds to the document results, books and accounting records.

Milan, 8 May 2019

Signed by Fritz Squindo Manager responsible for preparing the Company's financial reports

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