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Recordati Industria Chimica e Farmaceutica

Quarterly Report Jul 30, 2021

4056_ir_2021-07-30_4f7fa91f-6c45-4923-8e8f-c2c6fdc16ee6.pdf

Quarterly Report

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INTERIM FINANCIAL STATEMENTS

AT 30 JUNE 2021

CONTENTS

Page
MANAGEMENT REVIEW 3
Financial highlights 3
Corporate development news 5
Review of operations 5
Financial review 11
Business outlook 15
CONSOLIDATED CONDENSED FINANCIAL STATEMENTS AT 30 JUNE 2021 16
NOTES 22
CERTIFICATION OF THE CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
PURSUANT TO ART. 154-BIS
OF ITALIAN LGS. DECREE 58/98
49

This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast as a result of a variety of reasons, most of which are beyond the Recordati group's control.

The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the Recordati group's activities, and therefore, as such, it is not intended as medical scientific indications or recommendations, nor as advertising.

MANAGEMENT REVIEW FINANCIAL HIGHLIGHTS - First half 2021

NET REVENUE

€ (thousands) First half First half 0B0 B0BChange
2021 % 2020 % 2021/2020 %
Total net revenue 770,835 100.0 760,192 100.0 10,643 1.4
Italy 140,067 18.2 148,485 19.5 (8,418) (5.7)
International 630,768 81.8 611,707 80.5 19,061 3.1
KEY CONSOLIDATED P&L DATA
€ (thousands) First half % of First half % of 0B0 B0BChange
2021 revenue 2020 revenue 2021/2020 %
Net revenue 770,835 100.0 760,192 100.0 10,643 1.4
EBITDA(1) 300,450 39.0 311,091 40.9 (10,641) (3.4)
Operating income 250,368 32.5 261,510 34.4 (11,142) (4.3)
Net income 207,106 26.9 196,943 25.9 10,163 5.2
Adjusted net income (2) 209,819 27.2 225,568 29.7 (15,749) (7.0)
KEY CONSOLIDATED BALANCE SHEET DATA
30 June 31 December 0B0 B0BChange %
2021 2020 2021/2020
(867,416) (865,824) (1,592) 0.2
1,328,387 1,276,260 52,127 4.1

Second quarter 2021

NET REVENUE

€ (thousands) Second quarter Second quarter 0B0 B0BChange
2021 % 2020 % 2021/2020 %
Total net revenue 385,997 100.0 330,957 100.0 55,040 16.6
Italy 67,274 17.4 66,949 20.2 325 0.5
International 318,723 82.6 264,008 79.8 54,715 20.7

KEY CONSOLIDATED P&L DATA

€ (thousands) Second quarter
2021
% of
revenue
Second quarter
2020
% of
revenue
0B0 B0BChange
2021/2020
%
Net revenue 385,997 100.0 330,957 100.0 55,040 16.6
EBITDA(1) 150,429 39.0 138,219 41.8 12,210 8.8
Operating income 125,481 32.5 113,084 34.2 12,397 11.0
Net income 117,222 30.4 85,748 25.9 31,474 36.7
Adjusted net income (2) 105,386 27.3 100,393 30.3 4,993 5.0

(1) Net income before financial (income) expense, the provision for taxes, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, and non-recurring items.

(2) Net income excluding the amortization and write-downs of intangible assets (except software) and goodwill, and non-recurring items, net of tax effects.

(3) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives.

The second quarter of 2021 was characterized a gradual easing of the restrictive measures introduced during 2020 to deal with the COVID-19 epidemic, driving a partial recovery in the Group's main reference markets and a return to operating conditions that were closer to normal. Combined with the contribution from the new product Eligard®, this led net revenue to increase by 16.6% in the second quarter, offsetting the 10.3% drop recorded in the first three months of the year, with reported growth across the quarters affected by channel movements in 2020.

Consolidated net revenue in the first half of the year was € 770.8 million compared to € 760.2 million in the first half of last year (+1.4%), reflecting adverse currency exchange rate effect of around € 26.8 million and the contribution from Eligard® for 36.8 million (acquired under license from Tolmar International Ltd. in January). Net of these effects, growth for the half was at 0.1%, which, however, reflectsthe loss of exclusivity in 2020 of silodosin and pitavastatin (decrease of € 19.8 million) and the impact of the pandemic, especially on seasonal flu medications. The growth in products for the treatment of rare diseases was significant in the first half of the year, at 18.5%, thanks especially to the increases in Signifor® and Isturisa®, but also to the solid performance of Carbaglu® and Cystadrops® in the United States and in Europe.

EBITDA was € 300.5 million, down by 3.4% compared to the first half of 2020, accounting for 39.0% of revenue. The slight drop is primarily due to the investments to support growth in the rare diseases product portfolio and the costs related to integrating and promoting the new product Eligard®. Margins in the second quarter of 2020 had also benefited from a steep reduction in operations in the field following the introduction of restrictions on movement.

Operating income was € 250.4 million, down by 4.3% over the same period the previous year, at 32.5% of revenue.

Net income equalled € 207.1 million, which, despite the drop in operating income and higher financial expenses, increased by 5.2% compared to the first half of 2020, following the recognition of non-recurring tax benefits for € 26.2 million: € 12.9 million referred to the benefit from the completion of the reverse merger with Rossini Investimenti S.p.A. and Fimei S.p.A. and € 13.3 million from the release of deferred tax liabilities (net ofsubstitute tax due) following the revaluation of the Magnesio Supremo® brand, carried out by the subsidiary Natural Point S.r.l. in application of the 2020 "August Decree" and subsequent amendments and the interpretations by the Italian Tax Authorities. Net income accounted for 26.9% of revenue.

Adjusted net income was € 209.8 million, down by 7.0% over the same period in 2020 due to lower operating income and higher net financial expenses, at 27.2% of revenue.

The net financial position at 30 June 2021 recorded net debt of € 867.4 million compared to net debt of € 865.8 million at 31 December 2020. Over the period, € 35.0 million was paid to Tolmar International Ltd. pursuant to the license agreement for Eligard® and € 14.5 million to Almirall S.A. for the Flatoril® license. Furthermore, treasury shares were purchased for € 40.5 million, net of sales proceeds for the exercise of stock options, and dividends were paid for € 108.7 million. Free cash flow, which is operating cash flow before excluding these effects and financing items, was € 204.5 million in the period, an increase of € 7.7 million compared to the first half of 2020.

Shareholders' equity was € 1,328.4 million.

CORPORATE DEVELOPMENT NEWS

In January 2021, a License and Supply Agreement was finalized with Tolmar International Ltd to market Eligard® (leuprorelin acetate) in Europe, Turkey, Russia and other countries. Eligard® is a medicinal product for the treatment of advanced hormone-dependent prostate cancer and for the treatment of high-risk localized and locally advanced hormone-dependent prostate cancer, in combination with radiotherapy. During the first half of the year, net revenue for € 36.8 million was already recorded on the basis of this agreement. The active ingredient in Eligard®, leuprorelin acetate, presents in powder form, which is solubilized with a solvent and administered as a subcutaneous injection. Eligard® is available in three different doses (for 1 month, 3 months and 6 months of treatment, respectively) in a single kit containing two syringes.

Following a request from the European Medicines Agency (EMA), a new device is currently being developed to make administration of the product easier. The regulatory amendment should be submitted by the fourth quarter of 2021. Tolmar will continue to manufacture the product for Recordati, whereas Astellas will provide Recordati with certain transitory services over an agreed time period.

Recordati has made an upfront payment of € 35 million to Tolmar, with further milestones up to a total of € 105 million payable, plus royalties on sales.

Also in January 2021, the US Food and Drug Administration (FDA) approved a new indication for Carbaglu® (carglumic acid) 200 mg tablets as an adjunctive therapy to the primary treatment of acute hyperammonemia caused by propionic acidemia (PA) or by methylmalonic acidemia (MMA) in pediatric and adult patients. Carbaglu® is the first and only drug approved by the FDA for the treatment of acute hyperammonemia due to PA and MMA.

An agreement with Almirall S.A. was finalized in February 2021, to acquire the marketing rights on the Spanish market for Flatoril®, a medicine containing a combination of clebopride and simethicone, indicated for the treatment of functional gastrointestinal disorders.

In March 2021, in Japan, the Ministry of Health, Labour and Welfare (MHLW) approved Isturisa® (osilodrostat), for the treatment of patients with endogenous Cushing's syndrome for whom pituitary surgery is not an option or has not been curative. Marketing began at the end of June after having obtained the reimbursement price.

REVIEW OF OPERATIONS

The Group's business involves two segments: Specialty and Primary Care medicines and treatments for rare diseases. Business is conducted through our subsidiaries in Europe, Russia, Turkey, North Africa, the United States of America, Canada, Mexico, certain South American countries, Japan and Australia and, in the rest of the world, based on licensing agreements with leading pharmaceutical companies.

Consolidated net revenue in the first half of 2021 was € 770.8 million compared to € 760.2 million in the first half of last year (+1.4% or +4.9% at constant exchange rate), reflecting the growth in the portfolio of products for the treatment of rare diseases (both metabolic and endocrinological), the contribution of € 36.8 million from Eligard® (the new product obtained on license from Tolmar International Ltd. since January 2021), the drop in Specialty and Primary Care products (net of the new product Eligard®) which were affected by the persistent impact of the COVID-19 pandemic (in particular, products related to seasonal flu) and the loss of exclusivity of silodosin and pitavastatin during 2020. Worthy of note in the second quarter, Specialty and Primary Care products showed signs of recovery, growing by 6.8% on the second quarter of 2020 (net of the new product Eligard®). This increase also partially reflects the de-stocking effect recorded in the second quarter of 2020.

* Excluding sales of pharmaceutical chemicals, which were at € 25.6 million, down by 6.5%, representing 3.3% of total revenue.

The performance of products sold directly in more than one market (corporate products) during the first half of 2021 is shown in the table below and already reflects the effects of the pandemic referred to above.

€ (thousands) First half
2021
First half
2020
Change
2021/2020
6B6 B4B%
Zanidip® (lercanidipine) 79,066 82,561 (3,495) (4.2)
Zanipress® (lercanidipine+enalapril) 21,779 26,864 (5,085) (18.9)
Urorec® (silodosin) 31,395 42,328 (10,933) (25.8)
Livazo® (pitavastatin) 21,357 30,204 (8,847) (29.3)
Seloken®/Seloken® ZOK/Logimax®
(metoprolol/metoprolol + felodipine)
49,718 52,448 (2,730) (5.2)
Eligard® (leuprorelin acetate) 36,755 - 36,755 n.s.
Other corporate products* 124,846 136,571 (11,725) (8.6)
Drugs for rare diseases 181,051 152,736 28,315 18.5

* Include corporate OTC products for a total of € 51.4 million in 2021 and € 52.8 million in 2020 (-2.7%).

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 marketing organizations in Europe, including Central -Eastern Europe, Russia, Turkey and North Africa. In the other countries and in some of the countries mentioned above with co-marketing agreements, they are sold by our licensees.

Direct sales of products containing lercanidipine were down by 8.1% in the first half of 2021 due to the currency devaluation in Turkey and effect of the pressure from generic products in Italy. Sales to licensees, representing 52.8% of the total, were essentially in line with the previous year.

Zanipress® is an original pharmaceutical specialty developed be Recordati, indicated for the treatment of hypertension, which consists of a fixed combination of lercanidipine and enalapril. This product is successfully marketed directly by Recordati or by its licensees in 58 countries.

€ (thousands) First half
2021
First half
2020
Change
2021/2020
10B10 B8 B%
Direct sales 18,847 23,888 (5,041) (21.1)
Sales to licensees 2,932 2,976 (44) (1.5)
Total lercanidipine+enalapril sales 21,779 26,864 (5,085) (18.9)

Direct sales of Zanipress® in the first half of 2021 were down by 21.1%, mainly as a result of the price drop in Turkey and France. Sales to licensees, representing 13.5% of the total, came down slightly.

Urorec® (silodosin) is a specialty indicated for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). Currently, the product is marketed in 45 countries, with sales of € 31.4 million in the first half of 2021, down 25.8%, especially in Italy, France, Spain and Turkey and on indirect sales, due to competition from generic versions of the product following the expiry of its marketing exclusivity in February 2020.

Livazo® (pitavastatin), a statin indicated to lower elevated total and LDL cholesterol and sold directly in Spain, Portugal, Ukraine, Greece, Switzerland, Russia, other C.I.S. countries and Turkey, recorded sales for € 21.4 million in the first half of 2021, down by 29.3% due to the loss of exclusivity in August 2020. The number for the first half of 2021 is therefore being compared to the corresponding period in 2020 when Recordati still held exclusive marketing rights.

Sales of Seloken® /Seloken® ZOK (metoprolol) and Logimax® fixed dose combination (metoprolol and felodipine), metoprolol-based specialties belonging to the beta blocker class of drugs widely used in the treatment of various cardiovascular disorders, were at € 49.7 million in the first half of 2021, down by 5.2% compared to the same period the previous year due to the decrease in stocking in some countries.

Revenue for Eligard® was at € 36.8 million in the first half of 2021. This amount includes the direct sales made by Recordati and the gross profit realized by Astellas Pharma Europe S.A. (licensee of the product in Europe, Turkey, Russia and other countries up until 31 December 2020) and transferred to Recordati on the basis of the Transfer Service Agreement (TSA). In countries falling under the license contract with Tolmar International S.A. and where Recordati has not yet obtained transfer of the relevant Marketing Authorization or sales license, Astellas continues to sell the product and retrocede the relative gross profit (net of the expenses agreed in the TSA). The move to a Marketing Authorization or sales license for Recordati should occur during 2021 for most countries, in compliance with the regulations applicable in each country to which the license contract refers. Directsales were made during the first half of the year in Italy, Germany, Spain, Portugal, Poland, Belgium, the Netherlands and Nordic countries.

In the first half of 2021, sales of other corporate products totalled € 124.8 million, down by 8.6% over the same period the previous year, mainly due to the impact on seasonal flu products such as Polydexa®, Isofra®, and OTC Hexa products. Worthy of note is the solid performance of Reagila® (+22.4%) and the resurgence in growth of Procto-Glyvenol® (+18.7%), Citrafleet® (+33.4%), Casenlax® (+21.6%) and Fleet enema (+17.9%). Other corporate products comprise prescription as well as OTC products and include: Reagila® (cariprazine), Lomexin®

(fenticonazole), Urispas® (flavoxate), Kentera® (transdermal oxybutynin), TransAct® LAT (transdermal flurbiprofen), Rupafin®/Wystamm® (rupatadine), Lopresor® (metoprolol), Procto-Glyvenol® (tribenoside), Tergynan® (fixed combination of anti-infectives), in addition to CitraFleet®, Casenlax®, Fleet enema, Fosfosoda®, Reuflor®/Reuteri® (lactobacillus reuteri) and Lacdigest® (tilactase), the gastroenterology products, Polydexa®, Isofra® and Otofa®, othorynolaringological anti-infectives, the Hexa product range for seasonal ailments of the upper respiratory tract, Abufene® and Muvagyn® gynacological disorders, Virirec® (alprostadil) and Fortacin® (lidocaine+prilocaine), for andrological disorders.

In the first half of 2021, our specialties for the treatment of rare diseases, marketed directly in Europe, the Middle East, the U.S.A., Canada, Mexico and some countries in South America, Japan, Australia and through partners in other territories, generated sales of € 181.1 million, up by 18.5%, thanks especially to revenue from Signifor®, Signifor® LAR and Isturisa® for a total of € 56.3 million. Growth of Carbaglu®, Cystadrops® and Cystadane® as well as Ledaga® and Juxtapid® was also positive in the period, while a slight decrease was recorded for Panhematin® in the United States of America due to the entry of a competing drug at the end of the first quarter of 2020.

Sales of pharmaceutical chemicals, which comprise active substances produced in the Campoverde di Aprilia plant in Italy for the international pharmaceutical industry, were at € 25.6 million, down by 6.5%, representing 3.3% of total revenue.

€ (thousands) First half
2021
First half
2020
Change
2021/2020
12B12 B10 B%
Italy 135,715 144,483 (8,768) (6.1)
France 75,067 73,426 1,641 2.2
Germany 74,192 67,441 6,751 10.0
U.S.A. 79,886 60,054 19,832 33.0
Russia, other C.I.S. countries and Ukraine 33,275 46,091 (12,816) (27.8)
Turkey 35,140 44,787 (9,647) (21.5)
Spain 55,860 42,998 12,862 29.9
Portugal 22,300 22,306 (6) 0.0
Other Western European countries 50,300 44,613 5,687 12.7
Other C.E.E. countries 53,820 44,227 9,593 21.7
North Africa 19,089 22,790 (3,701) (16.2)
Other international sales 110,565 119,572 (9,007) (7.5)
Total net pharmaceutical revenue* 745,209 732,788 12,421 1.7

Sales from the Recordati subsidiaries, which include the above-mentioned product sales but exclude sales of pharmaceutical chemicals, are shown in the table below.

*Net revenue includes the sales of products and various revenue and excludes revenue from pharmaceutical chemical products.

Sales in countries affected by currency exchange fluctuations are shown below in their relative local currencies.

Local currency (thousands) First half
2021
First half
2020
Change
2021/2020
13B14 B%
Russia (RUB) 1,963,791 2,722,821 (759,030) (27.9)
Turkey (TRY) 308,208 303,684 4,524 1.5
United States of America (USD) 96,291 66,184 30,107 45.5

Net revenue in Russia and Turkey excludes sales of rare disease products.

Sales of pharmaceutical specialties in Italy were at € 135.7 million, down by 6.1% compared to the same period the previous year. This was mainly due to the decline in seasonal flu-related prescription medication and the decrease in sales of Urorec® due to the loss of exclusivity. Of note is the solid performance of Reagila® and the main OTC products, as well as the growth of sales in products for the treatment of rare diseases, amounting to € 10.0 million, up by 4.8%.

Sales for € 75.1 million were recorded in France, up by 2.2%, mainly due to the significant growth in sales of products for the treatment of rare diseases, amounting to € 16.1 million (+15.8%). The Specialty and Primary Care product portfolio was down, reflecting the persistent impact of the COVID-19 emergency, primarily in the first quarter of 2021 on the Hexa product range for seasonal flu conditions.

Sales for € 74.2 million were recorded in Germany, up by 10.0%, thanks to growth in the Specialty and Primary Care product portfolio (in particular, Ortoton Forte® and lercanidipine), as well as products for the treatment of rare diseases, for € 9.8 million (+18.5%).

Sales generated in Russia, Ukraine and in the countries within the Commonwealth of Independent States (C.I.S.) were at € 33.3 million, down by 27.8% compared to the same period the previous year and include estimated currency exchange losses of € 4.8 million. Revenue realized in Russia was RUB 1,963.8 million in local currency, down by 27.9% over the same period the previous year. The lower volume is due to the product portfolio's exposure to seasonal flu conditions and the policy being implemented by wholesalers in the country to reduce inventories compared to pre-pandemic levels, with an average decrease in inventories. Revenue generated in Ukraine and the other C.I.S. countries, mainly Belarus, Kazakhstan and Armenia, was also down at € 8.9 million. Sales of products for the treatment of rare diseases, amounting to € 2.6 million, increased sharply compared to the same period in 2020.

The Group's pharmaceutical business in the U.S.A. is dedicated to marketing products for the treatment of rare diseases. Sales were at € 79.9 million in the first half of 2021, up by 33.0%. In local currency, sales grew by 45.5%. Growth was mainly due to Signifor®, Signifor® LAR, Isturisa® (osilodrostat), Cystadrops® and Carbaglu®. The other main products in the US portfolio are Panhematin® (hemin for injection), which saw a decrease (even though recovering) over the same period the previous year due to the entry of a competing product at the end of the first quarter of 2020, Carbaglu® (carglumic acid), indicated for the treatment of acute hyperammonemia associated with NAGS deficiency, Cystadane® (anhydrous betaine) and Cosmegen® (dactinomycin for injection) used in the treatment of three rare cancers.

Sales in Turkey were at € 35.1 million, down by 21.5%, and included a negative currency exchange effect estimated at € 10.7 million. The Turkish branch's sales were up by 1.5% in local currency, mainly thanks to the sale of products for the treatment of rare diseases at € 2.8 million (+20.2%), whereas sales in the Specialty and Primary Care segment were impacted by less activity in the country and competition from generic products on the local product portfolio (in particular Cabral® and Kreval®).

Sales for € 55.9 million were recorded in Spain, up by 29.9%, mainly due to the contribution of Eligard® and products for the treatment of rare diseases, amounting to € 6.7 million, which grew by 19.0%. Gastrointestinal products performed well, after being effected by impact of the pandemic in 2020. Following the acquisition from Almirall, the first sales of Flatoril® for € 0.6 million were recorded. After losing exclusivity in 2020, sales of Livazo® and Urorec® came down by 51.9% and 11.4% respectively over the first half of the previous year.

Sales in Portugal were at € 22.3 million and in line with the same period the previous year. Drugs for the treatment of rare diseases, amounting to € 1.0 million, grew by 15.4%. After losing exclusivity in 2020, sales of Livazo® and Urorec® fell by 55.6% and 33.4% respectively compared to the first half of the previous year.

Sales in other Central and Eastern European countries, at € 53.8 million, include the sales from Recordati subsidiaries in Poland, the Czech Republic and 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 half of 2021, sales were up by 21.7% in total, thanks to the contribution of Eligard® and growth in Proctoglyvenol® and metoprolol, coupled with the 34.0% increase in products for the treatment of rare diseases, which reached € 4.8 million.

Sales in other Western European countries totalled € 50.3 million, increasing by 12.7%. They include sales of products for rare diseases and Specialty and Primary Care products from the Recordati subsidiaries in the United Kingdom, Ireland, Greece, Switzerland, Nordic countries (Finland, Sweden, Denmark, Norway and Iceland) and in BeNelux. Sales of products for the treatment of rare diseases in this area, amounting to € 14.1 million, were up by 3.4%.

Sales in North Africa were at € 19.1 million, down by 16.2% compared to the same period of the previous year (due to the failure to renew the importing licence in Algeria), and include the foreign revenue generated by Laboratoires Bouchara Recordati in these territories, and the sales generated by Opalia Pharma, the Group's Tunisian subsidiary. Sales in Tunisia in the first half of 2021 were up by 1.4%.

Other international sales, for € 110.6 million, were down by 7.5% compared to the same period the preceding year and comprise sales and other revenue from our licensees for our corporate products, Laboratoires Bouchara Recordati's and Casen Recordati's export sales, as well as sales of products for the treatment of rare diseases in the rest of the world. The drop is mainly due to the impact on sales to licensees of silodosin and pitavastatinbased products (where the Group lost marketing exclusivity in 2020) and termination of the Kentera distribution contract under license with Teva.

FINANCIAL REVIEW

INCOME STATEMENT

Income statement items are shown in the table below, with the relative percentage of net revenue and changes compared to the first half of 2020:

€ (thousands) First half % of First half % of 0B0 B0BChange
2021 revenue 2020 revenue 2021/2020 %
Net revenue 770,835 100.0 760,192 100.0 10,643 1.4
Cost of sales (205,940) (26.7) (211,754) (27.9) 5,814 (2.7)
Gross profit 564,895 73.3 548,438 72.1 16,457 3.0
Selling expenses (190,099) (24.7) (174,196) (22.9) (15,903) 9.1
Research and development
expenses
(81,129) (10.5) (71,242) (9.4) (9,887) 13.9
General and administrative
expenses
(40,729) (5.3) (36,684) (4.8) (4,045) 11.0
Other income/(expenses), net (2,570) (0.3) (4,806) (0.6) 2,236 (46.5)
Operating income 250,368 32.5 261,510 34.4 (11,142) (4.3)
Financial income/(expenses), net (14,868) (1.9) (7,083) (0.9) (7,785) n.s.
Pre-tax income 235,500 30.6 254,427 33.5 (18,927) (7.4)
Income taxes (28,394) (3.7) (57,484) (7.6) 29,090 (50.6)
Net income 207,106 26.9 196,943 25.9 10,163 5.2
Adjusted net income (1) 209,819 27.2 225,568 29.7 (15,749) (7.0)
EBITDA(2) 300,450 39.0 311,091 40.9 (10,641) (3.4)

(1) Net income excluding the amortization and write-downs of intangible assets (except software) and goodwill, and non-recurring items, net of tax effects.

(2) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, and non-recurring items.

Net revenue amounted to € 770.8 million, up by € 10.6 million compared to the first half of 2020. For a detailed analysis, please refer to the previous chapter "Review of Operations".

Gross profit was € 564.9 million, at 73.3% of sales, an improvement over the same period the previous year, mainly due to the positive effect from the increased impact of products for the treatment of rare diseases.

Selling expenses increased by 9.1% compared to the first half of 2020, due to the royalties paid to Tolmar International Ltd. for the new product Eligard® as well as the administrative charges payable to Astellas for the countries where Recordati's authorization to sell Eligard® has not yet been transferred. Selling expenses for the product portfolio for the treatment of rare diseases were also increased in order to support its growth.

Research and development expenses were at € 81.1 million, increasing by 13.9% over the first half of last year, mainly due to the investments to support endocrinology products and increased amortizations on the rights for Isturisa®, launched in the second quarter of 2020, and for Eligard®, acquired under license from Tolmar International in January 2021.

General and administrative expenses increased by 11.0% to strengthen the general coordination structure to support an increasingly complex portfolio and specifically to support the management of Signifor®, Isturisa® and Eligard® products, which are expected to record sustained growth in 2021 and into the future.

Net income and expenses amounted to € 2.6 million, compared to € 4.8 million in the first half of 2020. In both periods, these refer mainly to non-recurring costs related to the COVID-19 health emergency (at € 1.3 million in 2021 and € 4.0 million in 2020).

EBITDA (net income before income taxes, financial income and expenses, depreciation, amortization and writedowns of property, plant and equipment, intangible assets and goodwill, and non-recurring items) totalled € 300.5 million, down by 3.4% compared to the first half of 2020, at 39.0% of revenue. The amortization items classified above equalled € 48.5 million, of which € 35.9 million related to intangible assets, up by € 3.0 million over the same period the previous year, due to the launch of Isturisa® in the second quarter of 2020, the license contract with Tolmar International for Eligard® in January 2021, and € 12.6 million relating to property, plant and equipment, down by € 0.1 million over the first half of 2020.

The reconciliation of net income and EBITDA is reported below.

€ (thousands) First half
2021
First half
2020
Net income 207,106 196,943
Income taxes 28,394 57,484
Financial income/(expenses), net 14,868 7,083
Depreciation and amortization 48,506 45,622
Non-recurring operating expenses 1,576 3,959
EBITDA* 300,450 311,091

* Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, and non-recurring items.

The breakdown of EBITDA* by business segment is reported below.

€ (thousands)
Specialty and Primary Care segment
First half
2021
213,921
First half
2020
232,482
Change
2021/2020
(18,561)
10B10 B8 B%
(8.0)
Rare diseases segment 86,529 78,609 7,920 10.1
Total EBITDA* 300,450 311,091 (10,641) (3.4)

* Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, and non-recurring items.

The Specialty and Primary Care segment was 36.3% of EBITDA, and the rare disease segment was 47.8%.

Net financial expenses amounted to € 14.9 million, increasing by € 7.8 million over the same period the previous year and include net exchange losses for € 4.1 million and lower income compared to the first half of 2020, when a net benefit of € 2.6 million was recorded from the repayment of the two intercompany loans and the related cross-currency swaps.

The effective tax rate was 12.1%, which was significantly lower than the same period the previous year. Two nonrecurring tax benefits were recorded in the first half of 2021, for a total of € 26.2 million. As envisaged in the merger project, following the incorporation of its subsidiaries, Recordati S.p.A. inherited the ACE (Allowance for Corporate Equity) accrued by Rossini Investimenti S.p.A. for € 12.9 million. Furthermore, the revaluation of the Magnesio Supremo® brand by the subsidiary Natural Point S.r.l., with tax effects from 2021, resulted in the alignment between the accounting and tax amounts, and consequent release of the residual deferred tax liabilities to the income statement, calculated in the scope of the Purchase Price Allocation conducted for accounting purposes in the consolidated financial statements at the time of acquiring the subsidiary, impacting positively on the income statement for € 13.3 million, net of the substitute tax for € 1.6 million.

Net income, equalling € 207.1 million and at 26.9% of revenue, despite the drop in operating income and higher financial expenses, increased by 5.2% compared to the first half of 2020 due to the non-recurring tax benefits for € 26.2 million referred to above.

Adjusted net income was € 209.8 million and excludes amortization and write-downs of intangible assets (except software) and goodwill for an amount of € 27.8 million, non-recurring operating expenses for € 1.1 million, both net of tax effects, as well as the non-recurring tax income for € 26.2 million in the first half of 2021.

€ (thousands) First half First half
2021 2020
Net income 207,106 196,943
Amortization and write-downs of intangible assets
(excluding software)
35,095 32,786
Tax effect (7,311) (7,075)
Non-recurring operating expenses 1,576 3,959
Tax effect (429) (1,045)
Non-recurring tax income (26,218) 0
Adjusted net income* 209,819 225,568

The reconciliation of net income with adjusted net income* is reported below.

* Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, and non-recurring items, net of tax effects.

NET FINANCIAL POSITION

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

€ (thousands) 30 June
2021
31 December
2020
Change
2021/2020
%
Cash and cash equivalents 271,869 188,230 83,639 44.4
Short-term debts to banks and other lenders (29,106) (12,567) (16,539) n.s.
due within one year(1)
Loans -
(214,133) (261,216) 47,083 (18.0)
Leasing liabilities -
due within one year
(8,672) (9,038) 366 (4.0)
Short-term financial position 19,958 (94,591) 114,549 n.s.
due after one year(1)
Loans -
(871,278) (753,582) (117,696) 15.6
Leasing liabilities -
due after one year
(16,096) (17,651) 1,555 (8.8)
Net financial position (867,416) (865,824) (1,592) 0.2

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

The net financial position at 30 June 2021 recorded debt of € 867.4 million compared to debt of € 865.8 million at 31 December 2020. Over the period, € 35.0 million was paid to Tolmar International pursuant to the license agreement for Eligard® and € 14.5 million to Almirall S.A. for the Flatoril® license. Furthermore, treasury shares were purchased for € 40.5 million, net of sales proceeds from exercising stock options, and dividends were paid for € 108.7 million. Free cash flow, which is operating cash flow before excluding these effects and financial items, was € 204.5 million, an increase of € 7.7 million compared to the first half of 2020.

RELATED-PARTY TRANSACTIONS

In April, the merger deed was drafted for the merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. The subsequent filing with the Companies Register has finalized the transaction, with tax and accounting effects from 1 April 2021. The merger, approved by the Shareholders' Meeting on 17 December 2020, did not change the share capital of the incorporating company, nor any balancing cash payment. Furthermore, after the merger, Recordati S.p.A.'s balance sheet and earnings profile remained essentially consistent with prior to the transaction and, in particular, the merger did not alter Recordati's net financial position or, therefore, its investment capacity, or its capital allocation strategy or policy. As provided for in the draft terms of merger, Recordati S.p.A. inherited the ACE base and the ACE surplus of Rossini Investimenti S.p.A., with a non-recurring positive tax effect in 2021 of € 12.9 million and a recurring tax benefit of approximately € 1.2 million per year. ACE (Allowance for Corporate Equity) is tax relief for companies governed by Art. 1 of Italian Decree Law no. 201/2011 and by Italian Ministerial Decree 3/8/2017, and consists of the taxation of part of the taxable income proportional to the increases in equity. The merger also extinguished group taxation between Recordati S.p.A. and FIMEI S.p.A., and established that tax consolidation will continue between Recordati S.p.A. (as the consolidating company) and Italchimici S.p.A.

Following the transaction, the Group's immediate parent is Rossini S.à r.l., with headquarters in Luxembourg, which is owned by a consortium of investment funds controlled by CVC Capital Partners.

BUSINESS OUTLOOK

On 22 February, the Company announced the following financial targets for 2021, which foresaw revenue of between € 1,570 million and € 1,620 million, EBITDA(1) of between € 600 and € 620 million and adjusted net income(2) between € 420 and € 440 million.

Financial results for the first half of the year were in line with expectations and allow us to confirm the guidance for 2021, consistent with the objectives set at the start of the year, although as the pandemic continues to evolve, a level of uncertainty still remains, particularly for products related to seasonal flu.

On 6 May, the 2021-2023 plan was approved, which, including the contribution of additional acquisitions that could be finalized over the period in the plan, foresees revenue for 2023 between € 1,900 and 2,000 million, EBITDA(1) between € 720 and € 760 million and adjusted net income(2) between € 530 and € 560 million.

On 16 July 2021, the Board of Directors approved the new corporate governance structure of Recordati, which envisages the appointment of Rob Koremans as the new Chief Executive Officer (CEO), with effect from 1 December 2021. Andrea Recordati, the current CEO, will be appointed Chairman. The Company confirmed that under the leadership of Rob Koremans, Recordati will continue to consolidate its trajectory as set out in the recent three-year plan, combining volume driven organic growth of the current portfolio with value enhancing BD and M&A. As future Chairman Andrea Recordati will remain involved in the development of the Group's strategy, supporting the new CEO and the senior management team. In light of other important roles entrusted to him by the Italian Government, and having completed the transition process towards a new Governance of the Company, similarly on 16 July 2021, Chairman Alfredo Altavilla has tendered his resignation from his office, effective 1 December 2021.

(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, and non-recurring items.

(2) Net income excluding amortizations and write-downs of intangible assets (except for software) and goodwill, and non-recurring items, net of the tax effects.

Milan, 29 July 2021

for the Board of Directors Chief Executive Officer Andrea Recordati

CONSOLIDATED CONDENSED FINANCIAL STATEMENTS AT 30 JUNE 2021

RECORDATI S.p.A. and SUBSIDIARIES

CONSOLIDATED INCOME STATEMENT

€ (thousands) (1) Note First half
2021
First half
2020
Net revenue 3 770,835 760,192
Cost of sales 4 (205,940) (211,754)
Gross profit 564,895 548,438
Selling expenses 4 (190,099) (174,196)
Research and development expenses 4 (81,129) (71,242)
General and administrative expenses 4 (40,729) (36,684)
Other income/(expenses), net 4 (2,570) (4,806)
Operating income 250,368 261,510
Financial income/(expenses), net 5 (14,868) (7,083)
Pre-tax income 235,500 254,427
Income taxes 6 (28,394) (57,484)
Net income 207,106 196,943
Attributable to:
Equity holders of the Parent 207,084 196,918
Non-controlling interests 22 25
Earnings per share
Basic € 1.006 € 0.959
Diluted € 0.990 € 0.942

(1) Except amounts per share.

Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,792,226 in 2021 and 205,384,957 in 2020. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,332,930 shares in 2021 and 3,740,199 shares in 2020.

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

CONSOLIDATED BALANCE SHEET

ASSETS
€ (thousands) Note 30 June
2021
31 December
2020
Non-current assets
Property, plant and equipment 7 130,900 133,250
Intangible assets 8 1,132,928 1,115,811
Goodwill 9 559,899 562,116
Other equity investments and securities 10 39,672 45,581
Other non-current assets 11 31,388 6,861
Deferred tax assets 12 73,747 75,084
Total non-current assets 1,968,534 1,938,703
Current assets
Inventories
13 257,000 251,252
Trade receivables 13 304,542 268,897
Other receivables 13 52,717 47,291
Other current assets 13 12,187 10,245
Derivative instruments measured at fair value 14 9,067 7,036
Cash and cash equivalents 15 271,869 188,230
Total current assets 907,382 772,951

CONSOLIDATED BALANCE SHEET

SHAREHOLDERS' EQUITY AND LIABILITIES

€ (thousands) Note 30 June
2021
31 December
2020
Shareholders' equity
Share capital 26,141 26,141
Share premium reserve 83,719 83,719
Treasury shares (115,257) (87,516)
Reserve for derivative instruments (1,820) (2,659)
Translation reserve (217,296) (217,303)
Other reserves 64,746 70,707
Profits carried forward 1,280,771 1,151,053
Net income 207,084 354,984
Interim dividend 0 (103,143)
Shareholders' equity attributable to equity holders of the
Parent 1,328,088 1,275,983
Shareholders' equity attributable to non-controlling interests 299 277
Total shareholders' equity 16 1,328,387 1,276,260
Non-current liabilities
Loans -
due after one year
17 895,648 778,238
Provisions for employee benefits 18 21,513 21,174
Deferred tax liabilities 19 27,170 41,219
Other non-current liabilities 20 16,830 16,299
Total non-current liabilities 961,161 856,930
Current liabilities
Trade payables 21 160,355 132,096
Other payables 21 117,331 95,671
Tax liabilities 21 29,788 29,743
Other current liabilities 21 9,236 11,250
Provisions for risks and charges 21 14,059 17,113
Derivative instruments measured at fair value 22 3,688 9,770
Loans -
due within one year
17 222,805 270,254
Short-term debts to banks and other lenders 23 29,106 12,567
Total current liabilities 586,368 578,464
Total shareholders' equity and liabilities 2,875,916 2,711,654

STATEMENT OF CONSOLIDATED COMPREHENSIVE INCOME

€ (thousands) (1) First half First half
2021 2020
Net income 207,106 196,943
Gains/(losses) on cash flow hedges, net of tax effects 839 3,017
Gains/(losses) on translation of foreign financial statements 7 (23,101)
Gains/(losses) on equity-accounted investees, net of tax effects (5,482) (7,437)
Other changes, net of tax effects (42) (225)
Income and expenses recognized in shareholders' equity (4,678) (27,746)
Comprehensive income 202,428 169,197
Attributable to:
Equity holders of the Parent 202,406 169,172
Non-controlling interests 22 25
Per share value
Basic € 0.984 € 0.824
Diluted € 0.968 € 0.809

(1) Except amounts per share.

Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,792,226 in 2021 and 205,384,957 in 2020. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,332,930 shares in 2021 and 3,740,199 shares in 2020.

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

CONSOLIDATED STATEMENT OF CHANGE IN SHAREHOLDERS' EQUITY

Shareholders' equity attributable to equity holders of the Parent
€ (thousands) Share Share Treasury Reserve for Translation Other Profits Net income Interim Non Total
capital premium shares derivative reserve reserves carried dividend controlling
reserve instruments forward interests
Balance at 31 December
2019
26,141 83,719 (93,480) (5,357) (146,866) 64,651 999,708 368,825 (98,764) 234 1,198,811
Allocation of 2019 net
income 368,825 (368,825)
Dividend distribution (205,423) 98,764 (106,659)
Change in share-based
payments
(772) 3,211 2,439
Purchase of treasury shares (47,871) (47,871)
Sale of treasury shares 40,001 (14,639) 25,362
Other changes 726 726
Comprehensive income 3,017 (23,101) (7,662) 196,918 25 169,197
Balance at 30 June 2020 26,141 83,719 (101,350) (2,340) (169,967) 56,217 1,152,408 196,918 0 259 1,242,005
Balance at 31 December
2020
26,141 83,719 (87,516) (2,659) (217,303) 70,707 1,151,053 354,984(103,143) 277 1,276,260
Allocation of 2020 net
income
354,984 (354,984)
Dividend distribution (216,015) 103,143 (112,872)
Change in share-based
payments (829) 2,799 1,970
Purchase of treasury shares (66,891) (66,891)
Sale of treasury shares 39,150 (12,717) 26,433
Other changes 392 667 1,059
Comprehensive income 839 7 (5,524) 207,084 22 202,428
Balance at 30 June 2021 26,141 83,719 (115,257) (1,820) (217,296) 64,746 1,280,771 207,084 0 299 1,328,387

CONSOLIDATED CASH FLOW STATEMENT

€ (thousands) First half First half
2021 2020*
OPERATING ACTIVITIES
Net income 207,106 196,943
Income taxes 28,394 57,484
Net interest 8,954 8,201
Depreciation of property, plant and equipment 12,633 12,681
Amortization of intangible assets 35,873 32,941
Equity-settled share-based payment transactions 1,970 2,439
Other non-monetary components 1,632 1,097
Change in other assets and other liabilities (14,027) (16,350)
Cash flow generated/(used) by operating activities
before change in working capital 282,535 295,436
Change in:
-
inventories
(7,408) (37,542)
-
trade receivables
(34,947) 1,418
-
trade payables
28,774 (14,448)
Change in working capital (13,581) (50,572)
Interest received 103 382
Interest paid (9,147) (8,918)
Income taxes paid (46,563) (32,066)
Cash flow generated/(used) by operating activities 213,347 204,262
INVESTMENT ACTIVITIES
Investments in property, plant and equipment (8,944) (7,546)
Disposals of property, plant and equipment 158 0
Investments in intangible assets (57,774) (81,009)
Disposals of intangible assets 0 25
Cash flow generated/(used) by investment activities (66,560) (88,530)
FINANCING ACTIVITIES
Opening of loans 219,106 110,236
Repayment of loans (148,689) (50,091)
Payment of lease liabilities (4,735) (4,806)
Change in short-term debts to banks and other lenders 16,890 (5,984)
Dividends paid (108,699) (110,380)
Purchase of treasury shares (66,891) (47,871)
Sale of treasury shares 26,433 25,362
Cash flow generated/(used) by financing activities (66,585) (83,534)
Change in cash and cash equivalents 80,202 32,198
Opening cash and cash equivalents 188,230 187,923 **
Currency translation effect 2,958 (1,729)
Effect of merger 479 0
Closing cash and cash equivalents 271,869 218,392 **

* The 2020 figures were restated following the adoption of a new recognition method with the objective of better representing Group cash flow. These changes did not lead to significant changes in cash flow balances in terms of operating, investment, or financing activities as compared to what the cash flow statement showed last year.

** In 2020, the amounts net of short-term debts to banks and other lenders were shown, equal to € 13,392 thousand at 31 December 2019 and € 6,495 thousand at 30 June 2020.

The accompanying notes are an integral part of these statements. sta p accompanyi i statements.ng these ntegral art tements.

RECORDATI S.p.A. and SUBSIDIARIES

NOTES TO THE CONSOLIDATED CONDENSED FINANCIAL STATEMENTS AT 30 JUNE 2021

1. GENERAL INFORMATION

The consolidated condensed financial statements of the Recordati group for the period ended 30 June 2021 were prepared by Recordati Industria Chimica e Farmaceutica S.p.A. (the "Company" or "Parent Company"), with headquarters in Milan, Italy at Via Matteo Civitali 1, in a summarized format in compliance with IAS 34 "Interim Financial Reporting" and were approved by the Board of Directors on 29 July 2021, which authorized its public disclosure.

These consolidated condensed financial statements were prepared on a going concern basis because the Directors verified the non-existence of indicators of a financial, operational or other nature which could signal critical issues regarding the Group's ability to meet its obligations in the foreseeable future and, in particular, in the next 12 months.

Details regarding the accounting standards adopted by the Group are specified in Note 2.

The consolidated condensed financial statements at 30 June 2021 comprise those of the Parent Company and all its subsidiaries. The companies included in the scope of consolidation, their percentage of ownership and a description of their activity are set out in Note 28.

In April, the merger deed was drafted for the merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. The subsequent filing with the Companies Register has finalized the transaction, with tax and accounting effects from 1 April 2021. The merger, approved by the Shareholders' Meeting on 17 December 2020, did not change the share capital of the incorporating company, nor any balancing cash payment. Furthermore, after the merger, Recordati S.p.A.'s balance sheet and earnings profile remained essentially consistent with prior to the transaction and, in particular, the merger did not alter Recordati's net financial position or, therefore, its investment capacity, or its capital allocation strategy or policy. The table below shows the effects of the merger on the Group's equity position at 1 April 2021.

€ (thousands) ASSETS SHAREHOLDERS' EQUITY
AND LIABILITIES
Non-current assets Shareholders' equity
Other equity investments
and securities 3 Merger reserve 392
Other non-current assets 199
Total shareholders'
Total non-current assets 202 equity 392
Current assets Current liabilities
Other receivables 49 Trade payables 175
Provisions for risks and
Other current assets 13 charges 176
Cash and cash equivalents 479
Total current assets 541 Total current liabilities 351
Total shareholders'
Total assets 743 equity and liabilities 743

There were no other changes to the scope of consolidation during the first half of 2021. The Austrian subsidiary Pro Farma GmbH was renamed Recordati Austria GmbH.

These financial statements are presented in euro (€), rounded to thousands of euro, except where indicated otherwise.

2. SUMMARY OF ACCOUNTING STANDARDS

These consolidated condensed financial statements were prepared in a summarized format in compliance with IAS 34 "Interim Financial Reporting". These financial 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 2020, prepared in accordance with the IFRSs issued by the International Accounting Standards Board (IASB) and endorsed by the European Union pursuant to Regulation no. 1606/2002.

The preparation of the interim financial statements requires management to make estimates and assumptions that affect the reported amounts of revenue, expenses, assets, liabilities and the disclosure of contingent assets and liabilities at the date of the interim financial statements. If in the future, these estimates and assumptions, which are based on management's best judgement, should deviate from the actual circumstances, these will be modified in relation to the circumstances. In making the estimates and assumptions related to the preparation of these consolidated condensed financial statements, the impacts, also potential, deriving from the COVID-19 pandemic were taken into account. 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 are impairment loss indicators, which would require an immediate estimate of the loss.

In relation to financial instruments measured at fair value, IFRS 13 requires the classification of these instruments according to the standard's hierarchy levels, which reflect the significance of the inputs used in establishing the fair value. The following levels are used:

  • Level 1: unadjusted assets or liabilities subject to valuation on an active market;
  • Level 2: inputs other than prices listed under the previous point, which are observable directly (prices) or indirectly (derivatives from the prices) on the market;
  • Level 3: input which is not based on observable market data.

Disclosure of the net financial position is included in the section "Management Review" of this Report.

Accounting standards used in the preparation of the consolidated condensed financial statements

The accounting standards used in the preparation of the consolidated condensed financial statements were the same as those used in the preparation of the consolidated financial statements at 31 December 2020, except for the new standards and amendments that were adopted with effect from 1 January 2021. The Group did not adopt any new standard, interpretation or amendment in advance that was issued but not yet in force.

Several amendments and interpretations apply for the first time in 2021 but had no impact on the Group's consolidated condensed financial statements.

Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16: Interest Rate Benchmark Reform - Phase 2

The amendments include the temporary easing of requirements referring to the effects on the financial statements at a time when the interest rate offered on the interbank market (IBOR) is replaced by an alternative rate that is substantially free of risk (Risk Free Rate – RFR).

The amendments include the following practical expedients:

  • A practical expedient that provides for contract changes or changes in cash flow that are directly required by the reform to be treated as changes to a variable interest rate, the equivalent to a change in a market-based interest rate.
  • It provides for the changes required by the IBOR reform to be made in the scope of hedging relationships and hedging documentation without having to discontinue the hedging relationship.
  • It provides temporary relief to entities in having to comply with the requirements of separate identification when an RFR is designated as a hedge for a risk component.

These amendments had no impact on the consolidated financial statements, nor is any future impact for the Group foreseen.

3. NET REVENUE

The Group's operations and main revenue streams are those described in the last annual financial statements. The Group's revenue derives from contracts with customers and is not subject to seasonal fluctuations.

In the first half of 2021, net revenue amounted to € 770.8 million (€ 760.2 million in the same period in 2020) and can be broken down as follows:

€ (thousands) First half First half Change
2021 2020 2021/2020
Net sales 736,932 734,455 2,477
Royalties 2,844 2,920 (76)
Upfront payments 3,024 2,390 634
Various revenue 28,035 20,427 7,608
Total net revenue 770,835 760,192 10,643

Revenue for up-front payments is related to the activity of licensing and distribution of products in the portfolio and is recognized when it accrues along the time horizon of collaboration with customers. Revenue for € 3.0 million recorded in the first half of 2021 refers mainly to marketing agreements for Pitavastatin (€ 0.8 million), for lercanidipine (€ 0.6 million), for the lercanidipine+enalpril combination (€ 0.5 million), Cystadrops® (cysteamine hydrochloride) (€ 0.4 million), and for Silodosin (€ 0.3 million). The remaining balance of amounts already paid up front by customers, which will be recognized as revenue in future periods, recorded under other current liabilities (see Note 21), was € 8.4 million (€ 10.3 million at 31 December 2020).

"Various revenue" includes € 24.8 million, corresponding to the sales margin for Eligard® — a medicinal product for the treatment of prostate cancer — earned by Astellas Pharma Europe Ltd, as the previous licensee, and retroceded to Recordati following the contract finalised in January 2021 between Tolmar International Ltd. and Recordati S.p.A. for the assignment of the new product license. The first half of 2020 included € 19.3 million under this item, relating to the margin on sales of Signifor® and Signifor® LAR® realized by Novartis AG on behalf of Recordati following the transfer of the rights on the products. Subsequent to the transfer of the Marketing Authorization, initially in the United States of America and then gradually also for

Europe and other geographic areas, the recognition of the margin on the sales of Signifor® and Signifor® LAR® was progressively replaced by direct sales, which currently represent almost the entire revenue amount.

In the tables below, net revenue is disaggregated by product or product class and by geographic area by country. The tables also include a reconciliation of the disaggregated revenue with the Group's reportable segments.

Product or product class

€ (thousands) Specialty and
Primary Care
Specialty and
Primary Care
Rare
Diseases
Rare
Diseases
Total Total
2021 2020 2021 2020 2021 2020
Zanidip® 79,066 82,561 - - 79,066 82,561
Zanipress® 21,779 26,864 - - 21,779 26,864
Urorec® 31,395 42,328 - - 31,395 42,328
Livazo® 21,357 30,204 - - 21,357 30,204
Seloken®/Logimax® 49,718 52,448 - - 49,718 52,448
Eligard® 36,755 - - - 36,755 -
Other corporate
products 73,475 83,770 - - 73,475 83,770
Drugs for rare diseases 181,051 152,736 181,051 152,736
OTC 133,166 135,854 - - 133,166 135,854
Local product
portfolios 111,133 121,174 - - 111,133 121,174
Other revenue 6,314 4,849 - - 6,314 4,849
Pharmaceutical
chemicals 25,626 27,404 - - 25,626 27,404
Total net revenue 589,784 607,456 181,051 152,736 770,835 760,192

Geographic area by country

€ (thousands) Specialty and
Primary Care
2021
Specialty and
Primary Care
2020
Rare
Diseases
2021
Rare
Diseases
2020
Total
2021
Total
2020
Net pharmaceutical revenue
Italy 125,689 134,917 10,026 9,566 135,715 144,483
France 58,971 59,521 16,096 13,905 75,067 73,426
Russia, Ukraine, other CIS 30,685 44,767 2,590 1,324 33,275 46,091
Germany 64,348 59,136 9,844 8,305 74,192 67,441
Spain 49,196 37,400 6,664 5,598 55,860 42,998
Turkey 32,366 42,478 2,774 2,309 35,140 44,787
Portugal 21,318 21,455 982 851 22,300 22,306
Other Eastern European
countries 49,058 40,674 4,762 3,553 53,820 44,227
Other Western European
countries 36,177 30,957 14,123 13,656 50,300 44,613
North Africa 17,971 22,067 1,118 723 19,089 22,790
Other international sales 78,379 86,680 32,186 32,892 110,565 119,572
U.S.A. - - 79,886 60,054 79,886 60,054
Total net pharmaceutical
revenue 564,158 580,052 181,051 152,736 745,209 732,788
Net pharmaceutical chemicals
revenue
Italy 3,062 2,516 - - 3,062 2,516
Other European countries 9,607 8,512 - - 9,607 8,512
U.S.A. 2,827 3,241 - - 2,827 3,241
America (U.S.A. excluded) 2,230 2,457 - - 2,230 2,457
Australasia 7,158 9,669 - - 7,158 9,669
Africa 742 1,009 - - 742 1,009
Total net pharmaceutical
chemicals revenue 25,626 27,404 0 0 25,626 27,404
Total net revenue 589,784 607,456 181,051 152,736 770,835 760,192

4. OPERATING EXPENSES

Total operating expenses for the first half of 2021 amounted to € 520.5 million, up compared to the € 498.7 million for the corresponding period the previous year, and are classified by function as follows:

€ (thousands) First half
2021
First half
2020
Change
2021/2020
Cost of sales 205,940 211,754 (5,814)
Selling expenses 190,099 174,196 15,903
Research and development expenses 81,129 71,242 9,887
General and administrative expenses 40,729 36,684 4,045
Other (income)/expenses, net 2,570 4,806 (2,236)
Total operating expenses 520,467 498,682 21,785

The cost of sales was € 205.9 million, down compared to the first half of 2020, due to lower sales volumes. The impact on revenue was 26.7%, lower than the 27.9% in the first half of 2020 due to the positive effect from the increased portion of turnover in products for the treatment of rare diseases.

Selling expenses increased by 9.1% compared to the first half of 2020, mainly due to the royalties paid to Tolmar International Ltd. for the new product Eligard® as well as the administrative charges payable to Astellas for the countries where Recordati's authorization to sell Eligard® has not yet been transferred. Selling expenses for the product portfolio for the treatment of rare diseases were also increased in order to support its growth.

Research and development expenses were at € 81.1 million, increasing by 13.9% over the first half of last year due to the investments to support endocrinology products and increased amortizations on the rights for Isturisa®, launched in the second quarter of 2020, and for Eligard®, acquired under license from Tolmar International in January 2021.

General and administrative expenses increased by 11.0% to strengthen the general coordination structure to support an increasingly complex portfolio and specifically to support the management of Signifor®, Isturisa® and Eligard® products, which are expected to record sustained growth in 2021 and into the future.

The table below summarizes the more significant components of "Other income/(expenses), net".

€ (thousands) First half First half Change
2021 2020 2021/2020
Non-recurring costs for the COVID-19 epidemic 1,335 3,959 (2,624)
Other 1,235 847 388
Other (income)/expenses, net 2,570 4,806 (2,236)

The costs incurred for the COVID-19 epidemic are for donations in favour of hospitals and national health services, making work environments safe and the purchase of personal protective equipment.

Total operating expenses are analyzed by nature as follows:

€ (thousands) First half
2021
First half
2020
Change
2021/2020
Material consumption 153,903 157,453 (3,550)
Payroll costs 138,582 128,959 9,623
Other employee costs 13,659 15,070 (1,411)
Variable sales expenses 51,765 40,910 10,855
Depreciation and amortization 48,506 45,622 2,884
Utilities and consumables 19,008 17,773 1,235
Other expenses 95,044 92,895 2,149
Total operating expenses 520,467 498,682 21,785

The proportion of raw material consumption to net revenue was 20.0%, down by 0.7% compared to the same period in 2020.

The item "Payroll costs" includes stock option plan expenses totalling € 2.0 million in the first half of 2021 and € 2.4 million in the same period the previous year.

During 2019, some Group employees were designated as beneficiaries of an incentive plan, with a 5-year vesting period, under which they acquired, at nominal value, shares of Rossini Luxembourg S.à r.l., an indirect shareholder of Recordati S.p.A., and will benefit from a return at the expiry of the plan term. Recognition

according to the IFRS 2 accounting standard at 30 June 2021 caused an expense in the income statement of € 0.5 million.

Amortization items equalled € 48.5 million, of which, € 35.9 million related to intangible assets, increasing by € 3.0 million over the same period the previous year, due mainly to the launch of Isturisa® in the second quarter of 2020, the license contract with Tolmar International for Eligard® in January 2021, and € 12.6 million relating to property, plant and equipment, down by € 0.1 million on the first half of 2020.

5. NET FINANCIAL INCOME AND EXPENSES

In the first half of 2021 and same period in 2020, the balance of financing items was negative for € 14.9 million and € 7.1 million, respectively. The main balance items are summarized in the table below.

14,868 7,083 7,785
21 39 (18)
405 584 (179)
1,972 (1,858) 3,830
4,099 418 3,681
8,371 7,900 471
First half
2021
First half
2020
Change
2021/2020

Exchange losses were mainly determined by transactions in Russian roubles and U.S. dollars, currencies which were revalued against the euro compared to the end of 2020.

The change to "Net (income)/expense on short-term positions" is mainly attributable to the recognition in the first half of 2020 of the positive effects of the repayment of the two intercompany loans and relative cross-currency swaps for € 2.6 million.

6. INCOME TAXES

Income taxes, at € 28.4 million, include income taxes levied on all consolidated companies as well as the regional tax on production (IRAP) which is levied on all companies domiciled in Italy, and decreased by € 29.1 compared to the first half of 2020, following the recognition of non-recurring tax benefits for € 26.2 million.

After the merger of Recordati Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. was finalized in April, Recordati S.p.A. inherited the ACE base and the ACE surplus of Rossini Investimenti S.p.A., with a nonrecurring positive tax effect in 2021 of € 12.9 million and a recurring tax benefit of approximately € 1.2 million per year. ACE (Allowance for Corporate Equity) is tax relief for companies governed by Art. 1 of Italian Decree Law no. 201/2011 and by Italian Ministerial Decree 3/8/2017, and consists of the taxation of part of the taxable income proportional to the increases in equity. The merger also extinguished group taxation between Recordati S.p.A. and FIMEI S.p.A., and established that tax consolidation will continue between Recordati S.p.A. (as the consolidating company) and Italchimici S.p.A.

Following the approval of the 2020 year-end consolidated financial statements, the Italian subsidiary Natural Point S.r.l. revalued its self-generated figurative mark for Magnesio Supremo®, in application of Article 110 of Italian Decree Law no. 104 of 10 August 2020, converted with amendments by Law no. 126 of 13 October 2020. The subsidiary used the market value criterion to identify the maximum amount for the brand

revaluation, which was determined on the basis of an independent expert's report. In the subsidiary's financial statements at 31 December 2020, the brand was consequently revalued to € 53.6 million, which was lower than the maximum limit identified in the expert's report, and aligns to the net carrying amount recognised in the Recordati Group's consolidated financial statements. As permitted by the aforementioned legislation, the revalued amount in the subsidiary's financial statements was effective for tax purposes as from 1 January 2021, with the payment of substitute tax for € 1.6 million, equalling 3% of the revalued amount.

The higher value for the brand for € 61.2 million (which following amortisations, became € 53.6 million at 31 December 2020) had already been identified in the consolidated financial statements when allocating the surplus on the price paid in June 2018 to acquire the subsidiary, in relation to its carrying amount, and considering that this higher value did not have tax relevance, the corresponding deferred tax liabilities were recognised at that time. The tax applicability of the revaluation by Natural Point S.r.l., which was confirmed in the Circulars issued by the Tax Revenue Agency during 2021, resulted in the alignment of the tax and accounting values, with the consequent release of the residual amount on the deferred tax liabilities recognized in the consolidated financial statements at 31 December 2020 for € 14.9 million. Taking into account the substitute tax for € 1.6 million, the net positive effect for the Group, amounting to € 13.3 million, was recognized in the income statement to reduce the income tax.

Following the advance agreement signed with the Advance Agreement and Disputes Office of the Italian Tax Authorities on 19 December 2019, which allows the Parent Company to benefit from a discount on taxable income connected with the direct use of intangible assets for the tax years 2015 to 2019, as from 2020, the Parent Company opted to subscribe (instead of renewing the agreement) to the new optional reverse charge mechanism provided for by Art. 4 of Italian Legislative Decree no. 34 of 30 April 2019 and therefore directly determine the discount on taxable income provided by the "Patent Box" for the current year, using the same criteria already agreed with the Tax Authorities and providing documentation supporting the calculation. The relevant benefit for the first half of 2021, totalling € 4.1 million, was recognized to reduce the tax amount.

7. PROPERTY, PLANT AND EQUIPMENT

The composition and change to property, plant and equipment, including the valuation of the right to use the assets conveyed under leases, are shown in the table below.

€ (thousands) Land and
buildings
Plant and
machinery
Other
equipment
Investments in
progress
Total
Cost
Balance at 31 December 2020 90,930 241,577 98,712 21,817 453,036
Additions 1,131 1,000 2,948 7,001 12,080
Disposals (929) (1,552) (2,122) (141) (4,744)
Other changes (680) 1,142 269 (2,995) (2,264)
Balance at 30 June 2021 90,452 242,167 99,807 25,682 458,108
Accumulated amortization
Balance at 31 December 2020 51,670 200,268 67,848 0 319,786
Amortization for the period 2,971 4,143 5,519 0 12,633
Disposals (849) (1,546) (2,085) 0 (4,480)
Other changes (88) (509) (134) 0 (731)
Balance at 30 June 2021 53,704 202,356 71,148 0 327,208
Net amount
31 December 2020 39,260 41,309 30,864 21,817 133,250
30 June 2021 36,748 39,811 28,659 25,682 130,900

Increases over the period amounted to € 12.1 million and mainly referred to the Parent Company (€ 7.6 million) and the German subsidiary Recordati Pharma GmbH (€ 0.8 million).

"Other changes" includes the conversion into euro of the property, plant and equipment recognized in different currencies, for a net decrease of € 1.6 million compared to 31 December 2020, primarily due to the devaluation of the Turkish lira.

The following table shows the measurement of the right to use the assets conveyed under leases, determined as prescribed by the accounting standard IFRS 16.

€ (thousands) Land and
Buildings
Plant and
machinery
Other
equipment
Total
Cost
Balance at 31 December 2020 20,619 1,082 19,861 41,562
Additions 1,005 0 2,167 3,172
Disposals (929) (5) (1,611) (2,545)
Other changes 99 0 (188) (89)
Balance at 30 June 2021 20,794 1,077 20,229 42,100
Accumulated amortization
Balance at 31 December 2020 6,684 188 8,255 15,127
Amortization for the period 1,871 105 3,014 4,990
Disposals (848) (5) (1,560) (2,413)
Other changes 11 0 (122) (111)
Balance at 30 June 2021 7,718 288 9,587 17,593
Net amount
31 December 2020 13,935 894 11,606 26,435
30 June 2021 13,076 789 10,642 24,507

Rights of use of leased assets refer mainly to the office premises of several Group companies and to the cars used by medical representatives operating in their territories.

8. INTANGIBLE ASSETS

The composition and change in 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 2020 1,029,335 504,149 20,651 48,436 1,602,571
Additions 846 50,209 113 6,484 57,652
Disposals (1) (17) (3) 0 (21)
Other changes (3,758) 1,654 142 (1,160) (3,122)
Balance at 30 June 2021 1,026,422 555,995 20,903 53,760 1,657,080
Accumulated amortization
Balance at 31 December 2020 253,685 214,572 18,503 0 486,760
Amortization for the period 22,775 12,829 269 0 35,873
Disposals (1) (17) (3) 0 (21)
Other changes 1,313 267 (40) 0 1,540
Balance at 30 June 2021 277,772 227,651 18,729 0 524,152
Net amount
31 December 2020 775,650 289,577 2,148 48,436 1,115,811
30 June 2021 748,650 328,344 2,174 53,760 1,132,928

Increases for the period include:

  • € 35.0 million for the license agreement with Tolmar International Ltd relating to acquiring the licence for the marketing rights of Eligard® (leuprorelin acetate), a medicinal product for the treatment of prostate cancer, in Europe, Turkey, Russia and other countries;
  • € 14.5 million paid to Almirall S.A. for a perpetual license agreement to market Flatoril® (combination of clebopride and simethicone) on the Spanish market. Flatoril® is a product for the treatment of functional gastrointestinal disturbances.

"Other changes" includes the conversion into euro of the value of the intangible assets held and recognized in different currencies, which determined a net decrease of € 5.6 million compared to 31 December 2020 mainly attributable to the devaluation of the Swiss franc for € 8.2 million, and the revaluation of the U.S. dollar for € 2.1 million and of the Russian rouble for € 0.7 million.

9. GOODWILL

Net goodwill at 30 June 2021 amounted to € 559.9 million, a decrease of € 2.2 million compared to 31 December 2020, and is attributed to the operational areas, which represent the same number of cash generating units:

  • France for € 74.2 million;
  • Russia for € 24.6 million;
  • Germany for € 48.8 million;
  • Portugal for € 32.8 million;
  • Treatments for rare diseases: 110.6 million;
  • Turkey for € 24.1 million;
  • Czech Republic for € 13.9 million;
  • Romania for € 0.2 million;
  • Poland for € 14.5 million;
  • Spain for € 58.1 million;
  • Tunisia for € 16.5 million:
  • Italy for € 133.2 million;
  • Switzerland for € 8.4 million.

Goodwill related to acquisitions made in countries outside the European Monetary Union is calculated in local currency and converted into euro at the period-end exchange rate. Compared to 31 December 2020, this determined a total net decrease of € 2.2 million attributable to the acquisitions made in Turkey (decrease of € 3.2 million), Switzerland (decrease of € 0.1 million), Tunisia (decrease of € 0.1 million), Poland (increase of € 0.1 million), Czech Republic (increase of € 0.4 million) and Russia (increase of € 0.7 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.

Despite the COVID-19 health emergency that continued to impact various aspects of the Group's business over the period, the results achieved are in line with expectations. From an outlook perspective, the analysis carried out by comparing data at 30 June 2021 in relation to the expected flows for each cash generating unit (CGU) to see whether these events and their consequences could reveal possible impairment indicators found no critical aspects to report. Even if there were to be a possible decrease in sales, no significant or persistent variances are expected in terms of margins and cash flows compared to what was envisioned in plans. Furthermore, any changes in market interest rates, and consequently the discounting rates should also not produce any significant impacts. It was consequently not deemed necessary to conduct impairment testing on the interim position at 30 June 2021.

10. OTHER EQUITY INVESTMENTS AND SECURITIES

At 30 June 2021, these amounted to € 39.7 million, down by € 5.9 million compared to 31 December 2020.

The main investment refers to the U.K. company PureTech Health plc, specializing in investments in start-up companies dedicated to innovative therapies, medical devices and new research technologies. Starting from 19 June 2015, the shares of the Company were admitted for trading on the London Stock Exchange. At 30 June 2021, the total fair value of the 9,554,140 shares held was € 38.0 million. The value of the investment was consequently adjusted to the stock exchange value and fell by € 4.5 million, compared to 31 December

2020, with a counter-item accounted for, net of the related tax effect, in the statement of gains and losses recognized in shareholders' equity.

This item also includes € 1.7 million regarding an investment made during 2012 in Erytech Pharma S.A., a listed French biopharmaceutical company, focused on developing new therapies for rare oncological pathologies and orphan diseases. The investment, originally structured as a non-interest-bearing loan, was converted into 431,034 company shares in May 2013. The value of the investment was adjusted to the stock exchange value and decreased by € 1.4 million, compared to 31 December 2020, with a counter-item accounted for, net of the related tax effect, in the statement of gains and losses recognized in shareholders' equity.

11. OTHER NON-CURRENT ASSETS

At 30 June 2021, this item came to € 31.4 million, up by € 24.5 million compared to 31 December 2020. The increase is primarily attributable to the recognition of assets for the subsidiary Recordati AG in the scope of the contract agreements with Novartis AG referring to the acquisition of rights on the Signifor® and Signifor® LAR products.

12. DEFERRED TAX ASSETS

At 30 June 2021, deferred tax assets amounted to € 73.7 million, down by a net € 1.3 million compared to 31 December 2020. The effect of deferred tax assets related to components of other comprehensive income is a net decrease of € 0.2 million.

13. CURRENT ASSETS

Inventories amounted to € 257.0 million, up by € 5.7 million compared to 31 December 2020.

Trade receivables amounted to € 304.5 million at 30 June 2021, up by € 35.6 million compared to 31 December 2020. The balance is less the provision for € 14.3 million, a decrease of € 0.8 million compared to 31 December 2020, recognized under selling expenses, which reflects the collection risk connected with certain customers and geographic areas. Average days sales outstanding are 63.

Other receivables amounted to € 52.7 million, up by € 5.4 million compared to 31 December 2020.

Other current assets were at € 12.2 million and refer mainly to prepaid expenses.

14. DERIVATIVE INSTRUMENTS MEASURED AT FAIR VALUE (included in current assets)

The measurement at market (fair value) of cross-currency swaps entered into by the Parent Company to hedge the US\$ 75 million loan issued on 30 September 2014 gave rise to a € 8.3 million asset at 30 June 2021. This amount represents the potential benefit of a lower value in euro of the future dollar denominated principal and interest flows, in view of the revaluation of the foreign currency with respect to the moment in which the loan and hedging instruments were negotiated. In particular, the change in fair value of the derivative hedging the US\$ 50 million tranche of the loan, provided by Mediobanca, was positive for € 5.5 million, and that hedging the US\$ 25 million tranche of the loan, provided by UniCredit, yielded a € 2.8 million positive change.

At 30 June 2021, other hedging transactions were in place on foreign currency positions, the measurement of which was positive for a total of € 0.8 million, recognized to the income statement and offsetting the exchange losses arising from the valuation of the underlying positions at current exchange rates.

The fair value of these hedging derivatives is measured at level 2 of the hierarchy provided for in the IFRS 13 accounting standard. The fair value is equal to the current value of the estimated future cash flows. Estimates of future floating-rate cash flows are based on quoted swap rates futures prices and interbank borrowing rates. Estimated cash flows are discounted using a yield curve which reflects the relevant benchmark interbank rate used by market participants for pricing interest rate swaps.

15. CASH AND CASH EQUIVALENTS

At 30 June 2021, the balance of this item amounted to € 271.9 million, increasing by € 83.6 million on 31 December 2020, and are mainly denominated in euro, US dollars, pounds sterling and comprise current account deposits and short-term time deposits.

16. SHAREHOLDERS' EQUITY

Shareholders' Equity at 30 June 2021 was € 1,328.4 million, an increase of € 52.1 million compared to 31 December 2020 due to the combined effect of the following reasons:

  • increase of € 207.1 million from income for the period;
  • increase of € 2.0 million from cost of stock option plans set-off directly in equity;
  • decrease of € 66.9 million from the purchase of 1,500,000 treasury shares;
  • increase of € 26.4 million from the disposal of 1,113,250 treasury shares to service the stock option plans;
  • increase of € 0.8 million from the recognition of cross-currency swaps, the underlying loans and interest rate swaps, hedged foreign currency loans and interest rate swap transactions, net of the relative tax effect;
  • decrease of € 5.5 million from the application of IFRS 9, almost entirely attributable to the change in fair value of the equity investment in PureTech Health plc and in Erytech Pharma S.A., net of the relative tax effect;
  • increase of € 1.1 million from other changes;
  • decrease of € 112.9 million from the distribution of the dividend balance.

In consideration of the fact that the Italian company Recordati Rare Diseases Italy is 99% owned, this gave rise to a minority interest of € 299.0 thousand. SHOULD WE INCLUDE A NOTE SAYING THAT THE SHARE WAS ACQUIRED IN JULY?

At 30 June 2021, the Company has three existing stock option plans in favour of certain Group employees: the 2014-2018 plan with the grant of 29 July 2014 and 13 April 2016 and the 2018-2022 plan, with the grant of 3 August 2018, and the 2021-2023 plan with the grant of 6 May 2021. The strike price for the options is the average of the Parent Company's listed share price during the 30 days prior to the grant date. The options are vested over a period of five years in the case of the less recent grants, and three years for the 2021 grant. They lapse if they are not exercised within the eighth year after the grant date. Options cannot be exercised if the employee leaves the Company before they are vested.

Strike price Quantity Granted Exercised in Cancelled and Quantity
(€) 1.1.2021 2021 2021 expired 2021 30.6.2021
Grant date
29 July 2014 12.29 778,500 - (228,500) - 550,000
13 April 2016 21.93 1,587,500 - (405,000) (4,500) 1,178,000
3 August 2018 30.73 3,841,000 - (479,750) (58,000) 3,303,250
6 May 2021 45.97 - 3,219,500 - - 3,219,500
Total 6,207,000 3,219,500 (1,113,250) (62,500) 8,250,750

Stock options outstanding at 30 June 2021 are detailed in the following table:

At 30 June 2021, 3,216,052 treasury shares were held in the portfolio, an increase of 386,750 shares compared to 31 December 2020. The change was due to the disposal of 1,113,250 shares for an amount of € 26.4 million to enable the options attributed to employees as part of the stock option plans to be exercised and to the purchase of 1,500,000 shares for an amount of € 66.9 million. The total cost to purchase the treasury shares in the portfolio was € 115.3 million, with an average unit price of € 35.84.

During 2019, some Group employees were designated as beneficiaries of an incentive plan, with a 5-year vesting period, under which they acquired, at nominal value, shares of Rossini Luxembourg S.à r.l., an indirect shareholder of Recordati S.p.A., and will benefit from a return at the expiry of the plan term.

17. LOANS

At 30 June 2021, loans amounted to € 1,118.5 million, increasing by a net € 70.0 million compared to 31 December 2020.

This item includes the liabilities deriving from the application of the IFRS 16 accounting standard, representing the obligation to make the payments provided for in the existing leases for a total amount of € 24.8 million, a net decrease of € 1.9 million compared to 31 December 2020.

In the first half of 2021, new bank loans were taken out for 219.1 million and new lease contracts were signed for € 3.2 million, whereas a total of € 153.4 million was repaid, of which € 4.7 million related to lease liabilities. The € 25.0 million loan with Banca Nazionale del Lavoro was repaid on the expiry of the contract in March, with the payment of the last installment of € 6.3 million. With the aim of improving the management of its overall debt, the Parent Company repaid three loans in advance of their natural maturity. Specifically:

  • the loan from Centrobanca, maturing in December 2022, was extinguished in April with the repayment of the residual debt of € 13.6 million;
  • the debt with Intesa Sanpaolo (formerly UBI Banca) for € 40. 0 million, payable in a single instalment in October 2021, was extinguished in May;
  • the loan from ING Bank for € 22.5 million, maturing in December 2024, was extinguished in June, with the repayment of the entire subscribed amount.

The effect of the translation of loans in foreign currencies and of expenses incurred to place the loans, together with the early termination of a number of leases, determined a total net increase of € 1.1 million compared to 31 December 2020.

The main loans outstanding are:

a) € 180.0 million loan negotiated by the Parent Company in May 2021, provided by a consortium of national and international lenders led by Mediobanca. The main terms include a variable interest rate of the 6 month Euribor (with a zero floor) plus a fixed spread and a 5-year term, and single installment repayment on maturity. Disbursement, net of structuring and upfront fees, took place on 21 May 2021. The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured semi-annually, are the following:

• the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;

• the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

  • b) Loan for € 40.0 million entered into by the Parent Company on 30 March 2021 with Allied Irish Bank at a variable interest rate of the 6-month Euribor (with floor to zero) plus a variable spread based on a step up/step down mechanism on changes in the Leverage Ratio, with six-monthly interest payments and principal repayment, again on a semi-annual basis, starting from March 2022 until December March 2026. The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured semi-annually, are the following:
    • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
    • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.
    • These parameters are being observed.
  • c) Loan for 75.0 million Swiss francs taken out on 17 April 2020 by the subsidiary Recordati AG with UBS Switzerland AG, at a variable interest rate of the 3-months Libor on the Swiss currency (with a zero floor) plus a fixed spread, with quarterly interest payments and semi-annual repayment of principal starting September 2020 through March 2025. The value in euro of the outstanding loan at 30 June 2021 was € 54.6 million.

The loan, guaranteed by the Parent Company, includes covenants which, if not observed, could lead to a request for immediate repayment.

The financial covenants, measured semi-annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

d) Loan for € 400.0 million negotiated by the Parent Company in June 2019 aimed at supporting the Group's growth strategy. The loan, initially agreed with Mediobanca, Natixis and UniCredit was subsequently syndicated involving a pool of Italian and international banks. The terms of the loan provide for a variable interest rate at the 6-month Euribor (with a zero floor) plus a variable spread based on a step up/step down mechanism on changes in the Leverage Ratio, and a duration of 5 years with semi-annual repayment of the principal starting 30 June 2020 through June 2024. The disbursement, net of upfront commissions, took place on 30 July 2019. The debt outstanding recognized at 30 June 2021 amounted to a total of € 317.1 million.

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured semi-annually, are the following:

• the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;

  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3. These parameters are being observed.
  • e) Loan for € 150.0 million taken out by the Parent Company in November 2018 with Mediobanca, at a variable interest rate of the 6-month Euribor plus a variable spread based on a step up mechanism on changes in the Leverage Ratio, with quarterly interest payments and a duration of 5 years with semiannual repayments of principal starting November 2020 through November 2023. The debt outstanding at 30 June 2021 amounted to € 106.8 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 June 2021, the fair value of the derivative was measured at negative € 1.2 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

  • f) Loan for € 4.3 million granted to the Parent Company in July 2018 by Banca del Mezzogiorno-Mediocredito Centrale to fund investments in research, of which € 3.9 million at a reduced fixed interest rate, to be repaid in six semi-annual instalments starting 30 June 2019 through 31 December 2021, and € 0.4 million at a variable interest rate equal to the 6-month Euribor, to be repaid in two installments on 30 June and 31 December 2021. The total debt outstanding at 30 June 2021 amounted to € 0.9 million. The loan agreement does not include financial covenants.
  • g) Loan for € 15.0 million taken out by the Parent Company in November 2017 with Banca Passadore. The main conditions provide for a variable interest rate of the 3-month Euribor plus a fixed spread, quarterly payments of interest and a duration of 5 years with annual repayments of principal from November 2020 through November 2022. The total debt outstanding at 30 June 2021 amounted to € 10.0 million. The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:
    • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
    • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

h) Loan for € 75.0 million taken out by the Parent Company in October 2017 with Intesa Sanpaolo. The main conditions provide for a variable interest rate of the 6-month Euribor plus a fixed spread, semi-annual interest payments and a duration of 8 years with semi-annual repayments of principal from June 2019 through October 2025. The debt outstanding at 30 June 2021 amounted to € 48.1 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 June 2021, the fair value of the derivative was measured at negative € 0.9 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

i) Loan for € 50.0 million taken out by the Parent Company in September 2017 with UniCredit. The main conditions provide for a variable interest rate of the 6-month Euribor plus a fixed spread, semi-annual interest payments and repayment of the principal in a lump sum on 29 September 2021. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 June 2021, the fair value of the derivative was measured at negative € 0.2 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

j) Loan for € 50.0 million taken out by the Parent Company in September 2017 with UBI Banca (now Intesa Sanpaolo).The main conditions provide for a variable interest rate of the 6-month Euribor plus a fixed spread, semi-annual interest payments and repayment of the principal in a lump sum on 07 September 2022. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 June 2021, the fair value of the derivative was measured at negative € 0.5 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3. These parameters are being observed.
  • k) Loan for € 75.0 million taken out by the Parent Company in July 2017 with Mediobanca. The main conditions of the loan provide for a variable interest rate of the 6-month Euribor plus a fixed spread and a duration of 7 years with annual repayments of principal from July 2018 through July 2024. The debt outstanding at 30 June 2021 amounted to € 43.5 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 June 2021, the fair value of the derivative was measured at negative € 0.7 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

l) Privately placed guaranteed senior notes by the Parent Company in May 2017 for an overall amount of € 125.0 million at a fixed interest rate with repayment in annual installments starting on 31 May 2025 through 31 May 2032.

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, measured quarterly, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

m) Loan for € 25.0 million taken out by the Parent Company in December 2016 with Intesa Sanpaolo. The main conditions of the loan provide for a variable interest rate of the 6-month Euribor plus a fixed spread and a duration of 5 years with semi-annual repayments of principal from June 2019 through December 2021. The debt outstanding at 30 June 2021 amounted to € 4.2 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the debt to a fixed interest rate. At 30 June 2021, the fair value measurement of the derivative was slightly negative and was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

n) Loan disbursed on 16 October 2014 to the subsidiary Recordati Ilaç by IFC-World Bank for 71.6 million Turkish lira to finance the construction of a new production plant. The main conditions provide for a variable interest rate of the 3-month Trlibor plus a fixed spread and a duration of 8 years with quarterly repayments of principal from November 2016 through August 2022. The counter-value of the outstanding debt at 30 June 2021 amounted to € 1.4 million, down by € 0.8 million compared to 31 December 2020. This reduction was determined for € 0.2 million by the depreciation of the Turkish lira against the consolidation currency.

The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured quarterly, are the following:

  • the ratio of consolidated net financial position to consolidated shareholders' equity must be less than 0.75;
  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

o) Guaranteed senior notes issued by the Parent Company on 30 September 2014 for a total of US\$ 75 million, divided into two tranches: US\$ 50 million at fixed rate, repayable semi-annually starting 30 March 2022 and with maturity 30 September 2026, and US\$ 25 million again at fixed rate, repayable semi-

annually starting 30 March 2023 and with maturity 30 September 2029. The conversion of the loan at 30 June 2021 resulted in an increased liability for € 2.0 million compared to 31 December 2020, due to the revaluation of the U.S. dollar against the consolidation currency.

The loan was hedged at the same time with two cross-currency swap operations, which provide for the conversion of the debt into a total of € 56.0 million, of which € 37.3 million at a lower fixed rate for the tranche with maturity at 12 years and € 18.7 million again at a lower fixed rate for per that with maturity at 15 years. At 30 June 2021, hedging instruments measured at fair value were positive for a total of € 8.3 million, which was recognized directly as an increase in equity and as an increase in the asset item "Derivative instruments measured at fair value" (see Note 14).

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, measured quarterly, are the following:

  • the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of twelve consecutive months) must be less than 3;
  • the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.

These parameters are being observed.

18. PROVISIONS FOR EMPLOYEE BENEFITS

At 30 June 2021, this item amounted to € 21.5 million and reflects the Group's liability towards its employees determined in accordance with IAS 19.

19. DEFERRED TAX LIABILITIES

At 30 June 2021, deferred tax liabilities amounted to € 27.2 million, down by € 13.9 million compared to 31 December 2020. The decrease is mainly attributable to the release of € 14.9 million to the income statement following the revaluation of the Magnesio Supremo® brand by the Italian company Natural Point S.r.l. (see Note 6).

20. OTHER NON-CURRENT LIABILITIES

At 30 June 2021, other non-current liabilities amounted to € 16.8 million and referred entirely to future payments to Novartis AG for the marketing of Isturisa® on a number of European markets.

21. CURRENT LIABILITIES

Trade payables at € 160.4 million, included the accrual for invoices to be received.

Other liabilities amounted to € 117.3 million, increasing by € 21.7 million compared to 31 December 2020, and mainly include:

  • € 43.2 million due to employees and social security institutions;
  • € 20.6 million for Recordati AG in respect of Novartis AG, on the occurrence of contract conditions in the scope of acquiring the rights for Signifor®, Signifor® LAR and Isturisa®;
  • € 8.1 million which Recordati Rare Diseases Inc. must pay to U.S. health care insurance schemes;
  • € 2.2 million to be paid to the "Krankenkassen" (German health insurance schemes) by Recordati Pharma GmbH;

  • € 4.0 million related to the acquisition of a further 10% of the capital of Opalia Pharma determined on the basis of the put and call options provided for in the contract. The fair value of this purchase option is measured at level 2 as the valuation model considers the present value of the expected payments;
  • € 1.4 million to be paid to the Italian National Health Service resulting from the 1.83% discount applicable to the retail price of reimbursed pharmaceutical products before VAT.

Tax liabilities amounted to € 29.8 million, in line with the amount at 31 December 2020.

Other current liabilities amounted to € 9.2 million, down by € 2.0 million compared to 31 December 2020. An amount of € 8.4 million is attributable to the adoption of the IFRS 15 accounting principle, based on which some deferred revenue is recognized in the income statement in variable installments based on the fulfillment of the conditions for revenue recognition.

The provisions for risks and charges amounted to € 14.1 million, down by € 3.1 million compared to 31 December 2020.

22. DERIVATIVE INSTRUMENTS MEASURED AT FAIR VALUE (included in current liabilities)

The measurement at market (fair) value at 30 June 2021 of the interest rate swaps hedging a number of loans gave rise to a total € 3.5 million liability, which represents the unrealized opportunity of paying in the future, for the duration of the loans, the variable rates currently expected instead of the rates agreed. The amount is related to the interest rate swaps entered into by the Parent Company to hedge the interest rates on loans with Mediobanca (€ 1.9 million), Intesa Sanpaolo (€ 1.4 million) and UniCredit (€ 0.2 million).

In October 2019, Recordati S.p.A. entered into forward exchange contracts to hedge the intercompany loan granted to Recordati AG for an amount of 228.9 million Swiss francs. The measurement of the derivative at 30 June 2021 on the outstanding loan of 182.7 million Swiss francs was a negative € 0.1 million, which was recognized in the income statement, offsetting the exchange gains determined by the valuation of the underlying loan at current exchange rates.

At 30 June 2021, other hedging transactions were in place on foreign currency positions, with the measurement negative for a total of € 0.1 million, recognized in the income statement and offsetting the exchange gains arising from the valuation of the underlying positions at current exchange rates.

The fair value of these hedging derivatives is measured at level 2 of the hierarchy provided for in the IFRS 13 accounting standard. The fair value is equal to the current value of the estimated future cash flows. Estimates of future floating-rate cash flows are based on quoted swap rates futures prices and interbank borrowing rates. Estimated cash flows are discounted using a yield curve which reflects the relevant benchmark interbank rate used by market participants for pricing interest rate swaps.

23. SHORT-TERM DEBTS TO BANKS AND OTHER LENDERS

Debts to banks and other lenders at 30 June 2021 were € 29.1 million and comprise the use of short-term credit lines, overdrafts and interest due on existing loans.

24. OPERATING SEGMENTS

The financial information reported by line of business, in compliance with IFRS 8 – Operating Segments, is prepared using the same accounting principles used for the preparation and disclosure of the Group's consolidated financial statements. Two main business segments can be identified, the Specialty & Primary Care segment and the rare diseases segment.

The tables below show the figures for these segments at 30 June 2021 and include comparative data.

€ (thousands) Specialty and
Primary Care
segment
Rare diseases
segment
Values not
allocated
Consolidated
financial
statements
First half 2021
Net revenue 589,784 181,051 - 770,835
Expenses (409,575) (110,892) - (520,467)
Operating income 180,209 70,159 - 250,368
First half 2020
Net revenue 607,456 152,736 - 760,192
Expenses (411,933) (88,749) - (498,682)
Operating income 195,523 65,987 - 261,510

€ (thousands) Specialty and
Primary Care
Rare diseases
segment
Not allocated* Consolidated
financial
segment statements
30 June 2021
Non-current assets 1,188,661 740,201 39,672 1,968,534
Inventories 206,149 50,851 - 257,000
Trade receivables 231,282 73,260 - 304,542
Other receivables and other current
assets 52,030 12,874 9,067 73,971
Short-term financial investments,
cash and cash equivalents - - 271,869 271,869
Total assets 1,678,122 877,186 320,608 2,875,916
Non-current liabilities 43,117 22,396 895,648 961,161
Current liabilities 223,937 106,832 255,599 586,368
Total liabilities 267,054 129,228 1,151,247 1,547,529
Net capital employed 1,411,068 747,958
31 December 2020
Non-current assets 1,162,636 730,486 45,581 1,938,703
Inventories 210,089 41,163 - 251,252
Trade receivables 200,601 68,296 - 268,897
Other receivables and other current
assets 48,133 9,403 7,036 64,572
Cash and cash equivalents - - 188,230 188,230
Total assets 1,621,459 849,348 240,847 2,711,654
Non-current liabilities 57,621 21,071 778,238 856,930
Current liabilities 192,454 93,419 292,591 578,464
Total liabilities 250,075 114,490 1,070,829 1,435,394
Net capital employed 1,371,384 734,858

* Includes pharmaceutical chemical operations. ** Amounts not allocated refer to the items other equity investments and securities, cash and cash equivalents, loans, derivative instruments and short-term debts to banks and other lenders.

The pharmaceutical chemical business is considered part of the Specialty and Primary Care segment as it is mainly engaged in the production of active ingredients for finished pharmaceutical products, both from a strategic and organizational point of view.

25. LITIGATION AND CONTINGENT LIABILITIES

The Parent Company and some subsidiaries are parties to minor legal actions and disputes, the outcomes of which are not expected to result in any liability. The potential liabilities that can currently be measured are not for significant amounts. Some license agreements require the payment of future milestones as certain conditions occur, in which case their occurrence is as yet uncertain, with the consequence that the contractually required payments, estimated at around € 161 million and referring primarily to the contracts with Tolmar International, Novartis and ARS Pharmaceuticals, are currently merely potential liabilities.

26. RELATED-PARTY TRANSACTIONS

In April, the merger deed was drafted for the merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. The subsequent filing with the Companies Register has finalized the transaction,

with tax and accounting effects from 1 April 2021. The merger, approved by the Shareholders' Meeting on 17 December 2020, did not change the share capital of the incorporating company, nor any balancing cash payment. Furthermore, after the merger, Recordati S.p.A.'s balance sheet and earnings profile remained essentially consistent with prior to the transaction and, in particular, the merger did not alter Recordati's net financial position or, therefore, its investment capacity, or its capital allocation strategy or policy. As provided for in the draft terms of merger, Recordati S.p.A. inherited the ACE base and the ACE surplus of Rossini Investimenti S.p.A., with a non-recurring positive tax effect in 2021 of € 12.9 million and a recurring tax benefit of approximately € 1.2 million per year. ACE (Allowance for Corporate Equity) is tax relief for companies governed by Art. 1 of Italian Decree Law no. 201/2011 and by Italian Ministerial Decree 3/8/2017, and consists of the taxation of part of the taxable income proportional to the increases in equity. The merger also extinguished group taxation between Recordati S.p.A. and FIMEI S.p.A., and established that tax consolidation will continue between Recordati S.p.A. (as the consolidating company) and Italchimici S.p.A. Following the transaction, the Group's immediate parent is Rossini S.à r.l., with headquarters in Luxembourg, which is owned by a consortium of investment funds controlled by CVC Capital Partners.

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

27. SUBSEQUENT EVENTS

At the date of preparation of the financial statements, no significant events had occurred subsequent to the close of the period that would require changes to the values of assets, liabilities or the income statement.

On 16 July 2021, the Board of Directors approved the new corporate governance structure of Recordati, which envisages the appointment of Rob Koremans as the new Chief Executive Officer (CEO), with effect from 1 December 2021. Andrea Recordati, the current CEO, will be appointed Chairman. The Company confirmed that under the leadership of Rob Koremans, Recordati will continue to consolidate its trajectory, as set out in the recent three-year plan, by combining organic growth to the volumes of the current portfolio to create value on the basis of Business Development and M&A. As future Chairman, Andrea Recordati will continue to be involved in formulating the Group strategy, providing support to the new CEO and senior management team. In view of the other important appointments conferred on him by the Italian Government and with the transition process to a new corporate governance completed, similarly on 16 July 2021, Chairman Alfredo Altavilla tendered his resignation, which will also take effect from 1 December 2021.

28. SUBSIDIARIES INCLUDED IN THE CONSOLIDATED ACCOUNTS AT 30 June 2021

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 of pharmaceuticals
Italy 1,920,000.00 EUR Line-by-line
CASEN RECORDATI S.L.
Development, production, and sales of pharmaceuticals
Spain 238,966,000.00 EUR Line-by-line
BOUCHARA RECORDATI S.A.S.
Development, production, 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, and sales of pharmaceuticals
U.S.A. 11,979,138.00 USD Line-by-line
RECORDATI IRELAND LTD
Development, production, and sales of pharmaceuticals
Ireland 200,000.00 EUR Line-by-line
LABORATOIRES BOUCHARA RECORDATI S.A.S.
Development, production, and sales of pharmaceuticals
France 14,000,000.00 EUR Line-by-line
RECORDATI PHARMA GmbH
Marketing of pharmaceuticals
Germany 600,000.00 EUR Line-by-line
RECORDATI PHARMACEUTICALS LTD
Marketing of pharmaceuticals
United Kingdom 15,000,000.00 GBP Line-by-line
RECORDATI HELLAS PHARMACEUTICALS S.A.
Marketing of pharmaceuticals
Greece 10,050,000.00 EUR Line-by-line
JABA RECORDATI S.A.
Marketing of pharmaceuticals
Portugal 2,000,000.00 EUR Line-by-line
JABAFARMA PRODUTOS FARMACÊUTICOS S.A.
Promotion of pharmaceuticals
Portugal 50,000.00 EUR Line-by-line
BONAFARMA PRODUTOS FARMACÊUTICOS S.A.
Promotion 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
RECORDATI RARE DISEASES MIDDLE EAST FZ LLC
Marketing of pharmaceuticals
United Arab
Emirates
100,000.00 AED Line-by-line
RECORDATI AB
Marketing of pharmaceuticals
Sweden 100,000.00 SEK Line-by-line
RECORDATI RARE DISEASES S.à r.l.
Development, production, and sales of pharmaceuticals
France 320,000.00 EUR Line-by-line
RECORDATI RARE DISEASES UK Limited
Marketing of pharmaceuticals
United Kingdom 50,000.00 GBP Line-by-line
RECORDATI RARE DISEASES GERMANY GmbH
Marketing of pharmaceuticals
Germany 25,600.00 EUR Line-by-line
RECORDATI RARE DISEASES SPAIN S.L.
Marketing of pharmaceuticals
Spain 1,775,065.49 EUR Line-by-line
RECORDATI RARE DISEASES ITALY S.R.L.
Marketing of pharmaceuticals
Italy 40,000.00 EUR Line-by-line
RECORDATI BV
Marketing of pharmaceuticals
Belgium 18,600.00 EUR Line-by-line
FIC MEDICAL S.à r.l.
Promotion of pharmaceuticals
France 173,700.00 EUR Line-by-line
HERBACOS RECORDATI s.r.o.
Development, production, and sales of pharmaceuticals
Czech Republic 25,600,000.00 CZK Line-by-line
RECORDATI SK s.r.o.
Marketing of pharmaceuticals
Slovak Republic 33,193.92 EUR Line-by-line

Consolidated companies Head office Share capital Currency Consolidation
method
RUSFIC LLC
Development, promotion, and sales of pharmaceutical products
Russian Federation 3,560,000.00 RUB Line-by-line
RECOFARMA ILAÇ Ve Hammaddeleri Sanayi Ve Ticaret L.Ş.
Promotion of pharmaceutical products
Turkey 10,000.00 TRY Line-by-line
RECORDATI ROMÂNIA S.R.L.
Marketing of pharmaceuticals
Romania 5,000,000.00 RON Line-by-line
RECORDATI İLAÇ Sanayi Ve Ticaret A.Ş.
Development, production, and sales of pharmaceuticals
Turkey 180,000,000.00 TRY Line-by-line
RECORDATI POLSKA Sp. z o.o.
Marketing 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 of pharmaceuticals
Portugal 100,000.00 EUR Line-by-line
OPALIA PHARMA S.A.
Development, production, and sales of pharmaceuticals
Tunisia 9,656,000.00 TND Line-by-line
OPALIA RECORDATI S.à r.l.
Promotion 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 15,000,000.00 CHF Line-by-line
RECORDATI AUSTRIA 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.
Marketing of pharmaceuticals
Japan 10,000,000.00 JPY Line-by-line
NATURAL POINT S.r.l.
Marketing of pharmaceuticals
Italy 10,400.00 EUR Line-by-line
RECORDATI RARE DISEASES AUSTRALIA Pty Ltd
Marketing of pharmaceuticals
Australia 200,000.00 AUD Line-by-line
TONIPHARM S.a.s.
Marketing of pharmaceuticals
France 257,700.00 EUR Line-by-line
RECORDATI BULGARIA Ltd
Marketing of pharmaceuticals
Bulgaria 50,000.00 BGN Line-by-line

PERCENTAGE OF OWNERSHIP
Consolidated companies Recordati
Recordati
S.p.A. Parent
Pharma
Company
GmbH
Bouchara
Recordati
S.a.s.
Casen
Recordati
S.L.
Recordati
Orphan
Drugs
S.a.s.
Recordati
Rare
Diseases
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
100.00 100.00
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
RECORDATI RARE DISEASES
MIDDLE EAST FZ LLC
100.00 100.00
RECORDATI AB 100.00 100.00
RECORDATI RARE DISEASES
S.à r.l.
100.00 100.00
RECORDATI RARE DISEASES UK
Limited
100.00 100.00
RECORDATI RARE DISEASES
GERMANY GmbH
100.00 100.00
RECORDATI RARE DISEASES
SPAIN S.L.
100.00 100.00
RECORDATI RARE DISEASES
ITALY S.R.L.
99.00 99.00
RECORDATI BV 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
RECORDATI SK s.r.o. 100.00 100.00

PERCENTAGE OF OWNERSHIP
Consolidated companies Recordati
Recordati
S.p.A. Parent
Pharma
Company
GmbH
Bouchara
Recordati
S.a.s.
Casen
Recordati
S.L.
Recordati
Orphan
Drugs
S.a.s.
Recordati
Rare
Diseases
S.à r.l.
Herbacos
Recordati
s.r.o.
Recordati
Ilaç A.Ş.
Opalia
Pharma
S.A.
Recordati
AG
Total
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
RECORDATI AUSTRIA GmbH 100.00 100.00
RECORDATI RARE DISEASES
CANADA Inc.
100.00 100.00
RECORDATI RARE DISEASES
JAPAN K.K.
100.00 100.00
NATURAL POINT S.r.l. 100.00 100.00
RECORDATI RARE DISEASES
AUSTRALIA Pty Ltd
100.00 100.00
TONIPHARM S.a.s. 100.00 100.00
RECORDATI BULGARIA Ltd 100.00 100.00

CERTIFICATION OF THE CONSOLIDATED CONDENSED INTERIM FINANCIAL STATEMENTS PURSUANT TO ART. 154-BIS OF ITALIAN LGS. DECREE 58/98

  1. The undersigned, Andrea Recordati, in his capacity as Chief Executive Officer, and Luigi La Corte, as Financial Reporting Manager of Recordati S.p.A., pursuant to the provisions or Article 154-bis, paragraphs 3 and 4, of Italian Legislative Decree no. 58 of 24 February 1998, hereby certify:

  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 consolidated condensed financial statements for the first half of 2021.

  1. The undersigned certify further that:

2.1 the consolidated condensed financial statements at 30 June 2021:

  • have been prepared in accordance with the applicable International Accounting Standards, as endorsed by the European Union under the terms of Regulation (EC) no. 1606/2002 of the European Parliament and of the Council, of 19 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 and its consolidated subsidiaries.

2.2 The Interim Report includes a reliable analysis of the events occurring in the first six months of the year and their impact on the consolidated condensed financial statements, together with a description of the main risks and uncertainties referring to the remaining six months of the year. The Interim Report also includes a reliable analysis of the information on significant related-party transactions.

Milan, 29 July 2021

Chief Executive Officer Financial Reporting Manager

Andrea Recordati Luigi La Corte

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