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Recordati Industria Chimica e Farmaceutica

Quarterly Report Oct 28, 2021

4056_rns_2021-10-28_a1ddfe48-481e-4137-96f1-0dc4e762bd99.pdf

Quarterly Report

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INTERIM REPORT

AT 30 SEPTEMBER 2021

CONTENTS

Page
MANAGEMENT REVIEW 3
Financial highlights 3
Corporate development news and other key events 5
Review of operations 6
Financial review 11
Business outlook 15
CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2021 and NOTES 16
STATEMENT FROM THE MANAGER RESPONSIBLE FOR PREPARING
THE COMPANY'S FINANCIAL REPORTING
48

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 nine months 2021

NET REVENUE
€ (thousands) First nine First nine 0B0B0BChange
months 2021 % months 2020 % 2021/2020 %
Total net revenue 1,156,189 100.0 1,093,818 100.0 62,371 5.7
Italy 201,603 17.4 208,523 19.1 (6,920) (3.3)
International 954,586 82.6 885,295 80.9 69,291 7.8
KEY CONSOLIDATED P&L DATA
€ (thousands) First nine First nine 0B0B0BChange
months 2021% of revenue months 2020 % of revenue 2021/2020 %
Net revenue 1,156,189 100.0 1,093,818 100.0 62,371 5.7
EBITDA(1) 447,886 38.7 438,801 40.1 9,085 2.1
Operating income 372,927 32.3 364,037 33.3 8,890 2.4
Net income 296,386 25.6 274,100 25.1 22,286 8.1
Adjusted net income (2) 313,429 27.1 317,548 29.0 (4,119) (1.3)
KEY CONSOLIDATED BALANCE SHEET DATA
€ (thousands) 30 September 31 December 0B0B0BChange %
2021 2020 2021/2020
Net financial position(3) (714,720) (865,824) 151,104 (17.5)
Shareholders' equity 1,445,068 1,276,260 168,808 13.2
Third quarter 2021
NET REVENUE
€ (thousands) Third quarter Third quarter 0B0B0BChange
2021 % 2020 % 2021/2020 %
Total net revenue 385,354 100.0 333,626 100.0 51,728 15.5
Italy 61,536 16.0 60,038 18.0 1,498 2.5
International 323,818 84.0 273,588 82.0 50,230 18.4
KEY CONSOLIDATED P&L DATA
€ (thousands) Third quarter Third quarter 0B0B0BChange
2021% of revenue 2020 % of revenue 2021/2020 %
Net revenue 385,354 100.0 333,626 100.0 51,728 15.5
EBITDA(1) 147,436 38.3 127,710 38.3 19,726 15.4

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

Operating income 122,559 31.8 102,527 30.7 20,032 19.5 Net income 89,280 23.2 77,157 23.1 12,123 15.7 Adjusted net income (2) 103,610 26.9 91,980 27.6 11,630 12.6

(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 third quarter of 2021 confirmed the trends recorded during the second quarter, with a steady recovery in the Group's main reference markets and with operating conditions returning to near normal, even though limited access to medical personnel in several countries and social distancing measures continue to impact on certain product categories. This, combined with the contribution from the new product Eligard® and the continued growth in endocrinology products, resulted in a net revenue increase of 15.5% (+17% at constant exchange rate) in the third quarter compared to the same period in 2020, which had been more significantly impacted by the COVID 19 restriction measures.

Consolidated net revenue in the first nine months of 2021 was € 1,156.2 million compared to € 1,093.8 million in the same period the previous year (+5.7%), reflecting an adverse currency exchange rate effect of around € 31.7 million and the contribution from Eligard® for € 59.4 million (acquired under license from Tolmar International Ltd. in January). Net of these effects, growth was at 3.2%, which, however, reflects the loss of exclusivity in 2020 of silodosin and pitavastatin based products and the impact of the pandemic, especially on seasonal flu medications in the first part of 2021. The growth of the rare diseases portfolio was significant in the first nine months of 2021, at 20.2%, thanks especially to the increases in Signifor® and Isturisa®, but also to the solid performance of the main products in our portfolio.

EBITDA was € 447.9 million, up by 2.1% compared to the first nine months of 2020, accounting for 38.7% of revenue. Growth was driven by the solid revenue performance, which was partially offset by the increase in investments to support the growth of the rare diseases portfolio, the costs related to integrating and promoting the new product Eligard®, as well as the gradual recovery of activities in the field. It should be reiterated that margins in the first nine months of 2020 benefited from the sharp drop in operations in the territory following the introduction of restrictions on movement measures over most of this period.

Operating income was € 372.9 million, up by 2.4% over the same period of the previous year, at 32.3% of revenue.

Net income, at € 296.4 million, increased by 8.1% compared to the first nine months of 2020, with higher net financial expenses (due to exchange rate losses of € 6.8 million), and non‐recurring tax benefits recorded in the second quarter of € 26.2 million, of which € 12.9 million refer 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 of substitute 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 25.6% of revenue.

Adjusted net income was € 313.4 million, down by 1.3% over the same period in 2020 due primarily to the higher net financial expenses, at 27.1% of revenue.

The net financial position at 30 September 2021 recorded net debt of € 714.7 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 € 29.0 million, net of sales proceeds from exercising stock options, and dividends were paid for € 109.4 million. Free cash flow, which is operating cash flow before excluding these effects and financing items was € 352.9 million for the period, an increase of € 69.6 million compared to the first nine months of 2020, thanks to the increase in operating results and careful management of working capital.

Shareholders' equity was € 1,445.1 million.

CORPORATE DEVELOPMENT NEWS AND OTHER KEY EVENTS

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. Already over the first nine months of the year, net revenue for € 59.4 million was 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 first quarter of 2022. Tolmar will continue to manufacture the product for Recordati, whereas Astellas will provide Recordati with certain transitory services over an agreed time period. At 30 September 2021, the transfer of the Marketing Authorization or sales licence for Recordati was completed in around 30 countries, and the product is marketed directly in 23 countries and via partners in a further 6 countries.

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.

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. The current CEO, Andrea Recordati, will be appointed Chairman and will continue to be involved in formulating the Group strategy, providing support to the new CEO and senior management team. In light of other important appointments 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 tendered his resignation from office, effective 1 December 2021.

In October 2021, Recordati was included in the MIB ESG Index, the first index promoted by Euronext and Borsa Italiana, dedicated to blue‐chip companies demonstrating best ESG practices. The Group's inclusion in the index is further evidence of Recordati' firm commitment to environmental, social and governance issues. The index selects 40 listed Italian companies that stand out for their perfect integration of economic performance and ESG criteria, in line with the United Nations' Global Impact standards. It is work reiterating that Recordati is also included in the FTSE4Good Index series. As a testament to the Company's focus on sustainability, we note a general improvement in the ESG rating, including the CDP Climate Change program, MSCI, ISS and EcoVadis (the latter of which gave us a Gold rating in June 2021).

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 nine months of 2021 was € 1,156.2 million compared to € 1,093.8 million in the first nine months the previous year (+5.7% or +8.6% at constant exchange rate). The revenue trend over the first nine months of 2021 compared to 2020 reflects the growth in the rare diseases portfolio (for metabolic as well as endocrine diseases), the contribution of € 59.4 million from Eligard® (the new product under license from Tolmar International Ltd. since January 2021) and the slight drop in Specialty and Primary Care products (net of the new product Eligard®). The latter is the result of the persistent impact of the COVID‐19 pandemic (in terms of the decreased demand for seasonal flu products and destocking by wholesalers) and the loss of exclusivity of silodosin and pitavastatin products during 2020. Of note, however, during the third quarter (and already in the second), Specialty & Primary Care products showed signs of recovery, increasing by 4.6% (or +6.3% at constant exchange rate) compared to the third quarter of 2020, (net of the new product Eligard®).

* Excluding sales of pharmaceutical chemicals, which were at € 35.4 million, down by 6.6%, representing 3.1% of total revenue.

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

€ (thousands) First nine months
2021
First nine months
2020
Change
2021/2020
6B6B4B%
Zanidip® (lercanidipine) 107,193 106,083 1,110 1.0
Zanipress® (lercanidipine+enalapril) 31,307 38,234 (6,927) (18.1)
Urorec® (silodosin) 45,265 58,488 (13,223) (22.6)
Livazo® (pitavastatin) 31,849 42,450 (10,601) (25.0)
Seloken®/Seloken® ZOK/Logimax®
(metoprolol/metoprolol + felodipine)
72,991 77,699 (4,708) (6.1)
Eligard® (leuprorelin acetate) 59,362 59,362 n.s.
Other corporate products* 198,059 198,689 (630) (0.3)
Drugs for rare diseases 279,386 232,359 47,027 20.2

* Include corporate OTC products for a total of € 79.3 million in 2021 and € 78.4 million in 2020 (+1.2%).

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.

€ (thousands) First nine months
2021
First nine months
2020
Change
2021/2020
8B8B6B%
Direct sales 53,661 57,551 (3,890) (6.8)
Sales to licensees 53,532 48,532 5,000 10.3
Total lercanidipine sales 107,193 106,083 1,100 1.0

Direct sales of lercanidipine were down by 6.8% in the first nine months of 2021, mainly due to the drop in volume in Italy and the effect of the generic product entering the Turkish market, in addition to the adverse currency exchange rate effect due the devaluation of the Turkish lira). Sales to licensees, representing 49.9% of the total, grew primarily due to initial sales to a new licensee in China.

Zanipress® is an original pharmaceutical specialty developed by Recordati, indicated for the treatment of hypertension, consisting of a fixed combination of lercanidipine and enalapril. This product is successfully marketed directly by Recordati or by its licensees in 60 countries.

Total lercanidipine+enalapril sales 31,307 38,234 (6,927) (18.1)
Sales to licensees 3,832 4,117 (285) (6.9)
Direct sales 27,475 34,117 (6,642) (19.5)
€ (thousands) First nine months
2021
First nine months
2020
Change
2021/2020
10B10B8B%

Direct sales of Zanipress® were down by 19.5% in the first nine months of 2021, mainly due to competition from the generic formulations and adverse currency exchange with Turkey. Sales to licensees, representing 12.2% 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 56 countries, with sales of € 45.3 million in the first nine months of 2021, down by 22.6% due to competition from generic versions of the product following the expiry of its marketing exclusivity, in February 2020. Of note are the increased sales in Switzerland and Central‐Eastern European countries compared to the same period in 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 € 31.8 million in the first nine months of 2021, down by 25.0% due to the loss of exclusivity in August 2020. Regardless, there was growth in local currency in Turkey and Russia.

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 € 73.0 million in the first nine months of 2021, down by 6.1% compared to the same period of the previous year, due to the sharp increase in sales in Central‐Eastern European countries in 2020, especially Poland (due to the temporary reduction in the availability of products from the competition) and Germany.

Revenue for Eligard® was at € 59.4 million for the first nine months 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). At 30 September 2021, the transfer of the Marketing Authorization or sales license for Recordati occurred in most countries subject to the licence agreement with Tolmar, except for Russia and Ukraine.

In the first nine months of 2021, sales of other corporate products totalled € 198.1 million, remaining essentially in line with the same period of the previous year, confirming the positive performance in the third quarter of 2021 and which was already evident during the second quarter. In particular, the drop continued for the Hexa and polidexa, which was however counterbalanced by the sound performance of Procto‐Glyvenol (+13.5%), Reagila® (+25.6%), CitraFleet® (+24.5%), Casenlax® (+22.1%) and Fleet enema (+18.2%). 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 nine months 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 South American countries, Japan, Australia and through partners in other territories, generated sales of € 279.4 million, up by 20.2%, thanks especially to growth in revenue from Signifor®, Signifor® LAR and Isturisa® for a total of € 90.5 million compared to € 53.8 million during

the same period in 2020. Cystadrops® and Cystadane® as well as Ledaga® and Juxtapid® also recorded positive growth over the period.

Sales of pharmaceutical chemicals, which comprise active substances produced in the Campoverde di Aprilia plant in Italy for the international pharmaceutical industry, were at € 35.4 million, down by 6.6%, representing 3.1% of total revenue.

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

€ (thousands) First nine months
2021
First nine months
2020
Change
2021/2020
12B12B10B%
Italy 195,817 202,898 (7,081) (3.5)
France 112,204 109,132 3,072 2.8
Germany 111,727 100,595 11,132 11.1
U.S.A. 127,509 89,418 38,091 42.6
Russia, other C.I.S. countries and Ukraine 63,447 69,089 (5,642) (8.2)
Spain 85,855 63,079 22,776 36.1
Turkey 53,508 62,443 (8,935) (14.3)
Portugal 33,480 32,557 923 2.8
Other Western European countries 75,871 66,864 9,007 13.5
Other C.E.E. countries 80,281 67,098 13,183 19.6
North Africa 27,333 33,372 (6,039) (18.1)
Other international sales 153,726 159,341 (5,615) (3.5)
Total net pharmaceutical revenue* 1,120,758 1,055,886 64,872 6.1

*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 nine months
2021
First nine months
2020
Change
2021/2020
13B14B%
Russia (RUB) 4,040,288 4,276,804 (236,516) (5.5)
Turkey (TRY) 478,682 450,265 28,417 6.3
United States of America (USD) 152,529 100,598 51,931 51.6

Net revenue in Russia excludes sales of rare disease products.

Sales of pharmaceutical specialties in Italy were at € 195.8 million, down by 3.5% 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, the positive performance of Eligard®, as well as the growth of sales in the rare diseases portfolio, amounting to € 14.6 million, up by 3.3%.

Sales for € 112.2 million were recorded in France, up by 2.8%, mainly due to the significant growth in sales of products for the treatment of rare diseases, amounting to € 24.6 million (+7.4%). The Specialty and Primary Care product portfolio was down, reflecting the persistent impact of the COVID‐19 emergency, primarily on the Hexa seasonal flu product range and the loss of exclusivity of Urorec® (silodosin), which was partially offset by growth in Eligard®, metadone and the initial sales of Reselip®.

Sales in Germany equalled € 111.7 million and were up by 11.1%, thanks to growth in the Specialty and Primary Care product portfolio (in particular, Ortoton Forte®, Laxbene and Eligard®, which offset the decrease in metoprolol), as well as the rare diseases portfolio, for € 15.0 million (+14.6%).

Sales generated in Russia, Ukraine and in the countries within the Commonwealth of Independent States (C.I.S.) were at € 63.4 million, down by 8.2% compared to the same period the previous year, but recovering in the second and third quarters, and include estimated currency exchange losses of € 6.0 million. Revenue realized in Russia was RUB 4,040.3 million in local currency, down by 5.5% 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 implemented by wholesalers in the first half of 2021 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, grew to € 13.6 million. Sales of products for the treatment of rare diseases, amounting to € 3.7 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 € 127.5 million in the first nine months of 2021, up by 42.6%. In local currency, sales grew by 51.6%. Growth was mainly due to Signifor®, Signifor® LAR, Isturisa® (osilodrostat). Panhematin (hemin for injection) sales also grew over the period, having dropped during the months of the pandemic. The other main products in the US portfolio are Carbaglu®, Cystadrops®, Cystadane® (betaine anhydrous) and Cosmegen® (dactinomycin for injection), used in the treatment of three rare cancers.

Sales in Turkey were at € 53.5 million, down by 14.3%, and included a adverse currency exchange effect estimated at € 13.6 million. Sales in Turkey were up by 6.3% in local currency, mainly due to the growth in sales of products for the treatment of rare diseases, amounting to € 4.3 million (+34.3%). Sales in the Specialty and Primary Care segment were impacted by the decrease in the market for seasonal flu products and competition from local and generic products, which especially affected sales of Zanidip®, Zanipress®, Mictonorm® and Cabral®.

Sales in Spain equalled € 85.9 million, up by 36.1%, mainly due to the contribution of Eligard® and the rare diseases portfolio, amounting to € 10.0 million, which grew by 16.0%. 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 € 2.1 million were recorded. After losing exclusivity in 2020, sales of Livazo® and Urorec® fell by 45.5% and 7.0% respectively over the same period of the previous year.

Sales in Portugal were at € 33.5 million, increasing by 2.8% compared to the same period the previous year. Drugs for the treatment of rare diseases, amounting to € 1.4 million, grew by 14.9%. After losing exclusivity in 2020, sales of Livazo® and Urorec® fell by 53.8% and 32.6% respectively compared to the first nine months of the previous year. These losses were, however, offset by the new product Eligard® and increased sales of Reagila®.

Sales in other Central and Eastern European countries, at € 80.3 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 nine months of 2021, sales were up by 19.6% in total, thanks to the contribution of Eligard® and the growth of Procto‐Glyvenol®, coupled with the 33.3% increase in the rare diseases portfolio, at € 6.8 million.

Sales in other Western European countries totalled € 75.9 million, increasing by 13.5%. 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 Specialty & Primary Care products grew mainly thanks to Eligard®. Sales of products for the treatment of rare diseases in this area, amounting to € 21.2 million, increased by 3.1%.

Sales in North Africa totalled € 27.3 million, down by 18.1% compared to the same period of the previous year, due to the failure to renew the importing licence in Algeria for Hexaspray and vitamin D3. This includes 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 nine months of 2021 were up by 5.9%.

Other international sales, for € 153.7 million, were down by 3.5% 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 pitavastatin‐ based 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 nine months of 2020:

€ (thousands) First nine
months 2021
% of
revenue
First nine
months 2020
% of
revenue
0B0B0BChange
2021/2020
%
Net revenue 1,156,189 100.0 1,093,818 100.0 62,371 5.7
Cost of sales (313,005) (27.1) (308,237) (28.2) (4,768) 1.5
Gross profit 843,184 72.9 785,581 71.8 57,603 7.3
Selling expenses (287,007) (24.8) (256,701) (23.5) (30,306) 11.8
Research and development
expenses
(119,691) (10.4) (106,344) (9.7) (13,347) 12.6
General and administrative
expenses
(60,057) (5.2) (53,644) (4.9) (6,413) 12.0
Other income/(expenses), net (3,502) (0.3) (4,855) (0.4) 1,353 (27.9)
Operating income 372,927 32.3 364,037 33.3 8,890 2.4
Financial income/(expenses), net (22,191) (1.9) (11,192) (1.0) (10,999) 98.3
Pre‐tax income 350,736 30.3 352,845 32.3 (2,109) (0.6)
Income taxes (54,350) (4.7) (78,745) (7.2) 24,395 (31.0)
Net income 296,386 25.6 274,100 25.1 22,286 8.1
Adjusted net income (1) 313,429 27.1 317,548 29.0 (4,119) (1.3)
EBITDA(2) 447,886 38.7 438,801 40.1 9,085 2.1

(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 € 1,156.2 million, up by € 62.4 million compared to the first nine months of 2020. For a detailed analysis, please refer to the previous chapter "Review of Operations".

Gross profit was € 843.2 million, at 72.9% of sales, an improvement over the same period the previous year, mainly due to the positive effect from the increased impact of the rare diseases portfolio and recording the indirect sales margins for the new product Eligard® during the first six months of 2021.

Selling expenses increased by 11.8% compared to the first nine months 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. Marketing expenses also increased, mainly due to the launch of Isturisa®.

Research and development expenses were at € 119.7 million, increasing by 12.6% over the first nine months 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 12.0% 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.

Other net expenses amounted to € 3.5 million, compared to € 4.9 million in the first nine months of 2020. In both periods, these refer mainly to non‐recurring costs related to the COVID‐19 health emergency (at € 1.8 million in

2021 and € 5.2 million in 2020).

EBITDA (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) totalled € 447.9 million, up by 2.1% compared to the same period in 2020, at 38.7% of revenue. The amortization items classified above equalled € 72.9 million, of which € 54.0 million related to intangible assets, up by € 3.4 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 € 18.9 million relating to property, plant and equipment, down by € 0.1 million over the first nine months of 2020.

The reconciliation of net income and EBITDA is reported below.

€ (thousands) First nine months
2021
First nine months
2020
Net income 296,386 274,100
Income taxes 54,350 78,745
Financial income/(expenses), net 22,191 11,192
Depreciation and amortization 72,896 69,582
Non‐recurring operating expenses 2,063 5,182
EBITDA* 447,886 438,801

* 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) First nine months
2021
First nine months
2020
Change
2021/2020
10B10B8B%
Specialty and Primary Care segment 315,536 321,823 (6,287) (2.0)
Rare diseases segment 132,350 116,978 15,372 13.1
Total EBITDA* 447,886 438,801 9,085 2.1

* 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.

The Specialty and Primary Care segment was 36.0% of EBITDA, and the rare disease segment was 47.4%.

Net financial expenses amounted to € 22.2 million, increasing by € 11.0 million over the same period the previous year and include net exchange losses for € 6.8 million and lower income compared to the first nine months 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 15.5%, which was significantly lower than the same period the previous year. Two non‐ recurring tax benefits were recorded in the first nine months 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, at € 296.4 million and 25.6% of revenue, increased by 8.1% compared to the first nine months of 2020 thanks to the contribution of operating income and non‐recurring tax benefits for € 26.2 million referred to above, which were partially offset by higher financial expenses.

Adjusted net income was € 313.4 million and excludes amortization and write‐downs of intangible assets (except software) and goodwill for an amount of € 41.7 million, non‐recurring operating expenses for € 1.5 million, both net of tax effects, as well as the non‐recurring tax income for € 26.2 million in the first half of 2021.

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

€ (thousands) First nine months
2021
First nine months
2020
Net income 296,386 274,100
Amortization and write‐downs of intangible assets
(excluding software)
52,748 50,371
Tax effect (10,996) (10,732)
Non‐recurring operating expenses 2,063 5,182
Tax effect (554) (1,373)
Non‐recurring tax income (26,218) 0
Adjusted net income* 313,429 317,548

* 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 September
2021
31 December
2020
Change
2021/2020
%
Cash and cash equivalents 341,926 188,230 153,696 81.7
Short‐term debts to banks and other lenders (13,478) (12,567) (911) 7.2
Loans ‐ due within one year(1) (219,694) (261,216) 41,522 (15.9)
Leasing liabilities ‐ due within one year (8,474) (9,038) 564 (6.2)
Short‐term financial position 100,280 (94,591) 194,871 n.s.
Loans ‐ due after one year (1) (799,264) (753,582) (45,682) 6.1
Leasing liabilities ‐ due after one year (15,736) (17,651) 1,915 (10.8)
Net financial position (714,720) (865,824) 151,104 (17.5)

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

The net financial position at 30 September 2021 recorded debt of € 714.7 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 € 29.0 million, net of sales proceeds from exercising stock options, and dividends were paid for € 109.4 million. Free cash flow, which is operating cash flow before excluding these effects and financial

items, was € 352.9 million, an increase of € 69.6 million compared to the first nine months of 2020. The ratio of Net Debt/EBITDA (for the last 12 months) was 1.24.

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

Financial results for the first nine months of the year reflect a gradual recovery of our relevant markets in recent months and are in line with expectations set at the beginning of the year, which foresaw for 2021 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. Based on current trends, we expect results for the financial year at the lower end of the range, with the recent recovery in the seasonal flu‐market unlikely to fully offset the adverse impact in the first part of the year, assuming no significant new waves of COVID‐19 restrictions.

(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 amortization and write‐downs of intangible assets (except for software) and goodwill, and non‐recurring items, net of the tax effects.

Milan, 28 October 2021

for the Board of Directors Chief Executive Officer Andrea Recordati

CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2021 AND NOTES

RECORDATI S.p.A. and SUBSIDIARIES

CONSOLIDATED INCOME STATEMENT

€ (thousands) (1) Note First nine months
2021
First nine
months 2020
Net revenue 3 1,156,189 1,093,818
Cost of sales 4 (313,005) (308,237)
Gross profit 843,184 785,581
Selling expenses 4 (287,007) (256,701)
Research and development expenses 4 (119,691) (106,344)
General and administrative expenses 4 (60,057) (53,644)
Other income/(expenses), net 4 (3,502) (4,855)
Operating income 372,927 364,037
Financial income/(expenses), net 5 (22,191) (11,192)
Pre‐tax income 350,736 352,845
Income taxes 6 (54,350) (78,745)
Net income 296,386 274,100
Attributable to:
Equity holders of the Parent 296,386 274,063
Non‐controlling interests 0 37
Earnings per share
Basic € 1.439 € 1.333
Diluted € 1.417 € 1.311

(1) Except amounts per share.

Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,919,516 in 2021 and 205,603,780 in 2020. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,205,640 shares in 2021 and 3,521,376 shares in 2020.

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

CONSOLIDATED BALANCE SHEET

ASSETS
€ (thousands) Note 30 September 31 December
2021 2020
Non‐current assets
Property, plant and equipment 7 132,992 133,250
Intangible assets 8 1,128,036 1,115,811
Goodwill 9 560,309 562,116
Other equity investments and securities 10 41,963 45,581
Other non‐current assets 11 31,927 6,861
Deferred tax assets 12 76,203 75,084
Total non‐current assets 1,971,430 1,938,703
Current assets
Inventories 13 244,501 251,252
Trade receivables 13 300,769 268,897
Other receivables 13 44,880 47,291
Other current assets 13 15,018 10,245
Derivative instruments measured at fair value 14 11,021 7,036
Cash and cash equivalents 15 341,926 188,230
Total current assets 958,115
772,951
Total assets 2,929,545 2,711,654

CONSOLIDATED BALANCE SHEET

SHAREHOLDERS' EQUITY AND LIABILITIES

€ (thousands) Note 30 September
2021
31 December
2020
Shareholders' equity
Share capital 26,141 26,141
Share premium reserve 83,719 83,719
Treasury shares (98,924) (87,516)
Reserve for derivative instruments (1,584) (2,659)
Translation reserve (205,169) (217,303)
Other reserves 67,289 70,707
Profits carried forward 1,277,210 1,151,053
Net income 296,386 354,984
Interim dividend 0 (103,143)
Shareholders' equity attributable to equity holders of the
Parent 1,445,068 1,275,983
Shareholders' equity attributable to non‐controlling interests 0 277
Total shareholders' equity 16 1,445,068 1,276,260
Non‐current liabilities
Loans ‐ due after one year 17 824,701 778,238
Provisions for employee benefits 18 21,351 21,174
Deferred tax liabilities 19 27,787 41,219
Other non‐current liabilities 20 0 16,299
Total non‐current liabilities 873,839 856,930
Current liabilities
Trade payables 21 166,917 132,096
Other payables 21 133,098 95,671
Tax liabilities 21 40,197 29,743
Other current liabilities 21 8,414 11,250
Provisions for risks and charges 21 14,240 17,113
Derivative instruments measured at fair value 22 6,126 9,770
Loans ‐ due within one year 17 228,168 270,254
Short‐term debts to banks and other lenders 23 13,478 12,567
Total current liabilities 610,638 578,464
Total shareholders' equity and liabilities 2,929,545 2,711,654

STATEMENT OF CONSOLIDATED COMPREHENSIVE INCOME

€ (thousands) (1) First nine months First nine months
2021 2020
Net income 296,386 274,100
Gains/(losses) on cash flow hedges, net of tax effects 1,075 2,303
Gains/(losses) on translation of foreign financial statements 12,134 (60,466)
Gains/(losses) on equity‐accounted investees, net of tax effects (3,353) (9,333)
Other changes, net of tax effects (57) (208)
Income and expenses recognized in shareholders' equity 9,799 (67,704)
Comprehensive income 306,185 206,396
Attributable to:
Equity holders of the Parent 306,185 206,359
Non‐controlling interests 0 37
Per share value
Basic € 1.487 € 1.004
Diluted € 1.464 € 0.987

(1) Except amounts per share.

Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,919,516 in 2021 and 205,603,780 in 2020. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,205,640 shares in 2021 and 3,521,376 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
capital
Share
premium
reserve
Treasury
shares
Reserve for
derivative
instruments
Translation
reserve
Other
reserves
Profits
carried
forward
Net
income
Interim
dividend
Non‐
controlling
interests
Total
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
(285) 3,934 3,649
Purchase of treasury shares (47,871) (47,871)
Sale of treasury shares 49,056 (16,817) 32,239
Other changes 1,010 1,010
Comprehensive income 2,303 (60,466) (9,541) 274,063 37 206,396
Balance at 30 September
2020
26,141 83,719 (92,295) (3,054) (207,332) 54,825 1,151,237 274,063 0 271 1,287,575
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 (216,123) 103,143 (112,980)
Change in share‐based
payments
(400) 4,021 3,621
Purchase of treasury shares (66,891) (66,891)
Sale of treasury shares 55,483 (17,620) 37,863
Other changes 392 895 (277) 1,010
Comprehensive income 1,075 12,134 (3,410) 296,386 306,185
Balance at 30 September
2021
26,141 83,719 (98,924) (1,584) (205,169) 67,289 1,277,210 296,386 0 0 1,445,068

CONSOLIDATED CASH FLOW STATEMENT

€ (thousands) First nine First nine
months 2021 months 2020*
OPERATING ACTIVITIES
Net income 296,386 274,100
Income taxes 54,350 78,745
Net interest 13,326 12,710
Depreciation of property, plant and equipment 18,928 18,975
Amortization of intangible assets 53,968 50,607
Equity‐settled share‐based payment transactions 3,621 3,649
Other non‐monetary components 2,211 1,648
Change in other assets and other liabilities (14,632) (18,951)
Cash flow generated/(used) by operating activities
before change in working capital 428,158 421,483
Change in:
-
inventories
7,837 (43,361)
-
trade receivables
(29,721) 7,892
-
trade payables
34,730 (33,294)
Change in working capital 12,846 (68,763)
Interest received 214 440
Interest paid (11,476) (11,653)
Income taxes paid (61,599) (45,012)
Cash flow generated/(used) by operating activities 368,143 296,495
INVESTMENT ACTIVITIES
Investments in property, plant and equipment (15,344) (13,213)
Disposals of property, plant and equipment 158 0
Investments in intangible assets (61,400) (93,164)
Disposals of intangible assets 0 57
Acquisition of holdings in subsidiaries (304) 0
Cash flow generated/(used) by investment activities (76,890) (106,320)
FINANCING ACTIVITIES
Opening of loans 219,065 110,183
Repayment of loans (216,381) (74,237)
Payment of lease liabilities (7,203) (7,246)
Change in short‐term debts to banks and other lenders (762) 1,672
Dividends paid (109,389) (110,541)
Purchase of treasury shares (66,891) (47,871)
Sale of treasury shares 37,863 32,239
Cash flow generated/(used) by financing activities (143,698) (95,801)
Change in cash and cash equivalents 147,555 94,374
Opening cash and cash equivalents 188,230 187,923 **
Currency translation effect 5,662 (4,675)
Effect of merger 479 0
Closing cash and cash equivalents 341,926 277,622 **

* 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 € 14,729 thousand at 30 September 2020.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2021

1. GENERAL INFORMATION

The Interim Report for the Recordati Group for the period ended 30 September 2021 was prepared by Recordati Industria Chimica e Farmaceutica S.p.A. (the "Company" or the "Parent Company"), with headquarters in Milan at Via Matteo Civitali no. 1, was approved by the Board of Directors' meeting of 28 October 2021, which authorized distribution to the public.

The Interim Financial Statements at 30 September 2021 include the economic‐equity position 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

The remaining 1% of Recordati Rare Diseases Italy was acquired during the first nine months of 2021 for € 0.3 million. Furthermore, with the aim of extending the rare diseases sector into new markets, a Chinese company Recordati (Beijing) Pharmaceutical Co. Ltd, was established. Finally, 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 interim consolidated financial statements were prepared in accordance with the recognition and measurement criteria prescribed by the International Financial Reporting Standards (IFRS) adopted by the European Union, but 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 of regulation no. 1606/2002.

The preparation of the interim financial statements requires management to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements. If in the future, 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 interim financial statements, the impacts, even potential ones, 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.

Application of new accounting principles

The accounting policies applied in these interim financial statements are the same as those applied in the last annual financial statements.

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 nine months of 2021, net revenue amounted to € 1,156.2 million (€ 1,093.8 million in the same period in 2020) and can be broken down as follows:

€ (thousands) First nine months
2021
First nine months
2020
Change
2021/2020
Net sales 1,117,605 1,064,960 52,645
Royalties 4,045 4,141 (96)
Upfront payments 4,050 3,521 529
Various revenue 30,489 21,196 9,293
Total net revenue 1,156,189 1,093,818 62,371

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 € 4.1 million recorded in the first nine months of 2021 refers mainly to marketing agreements for pitavastatin (€ 1.1 million), for the lercanidipine+enalpril combination (€ 0.8 million), lercanidipine (€ 0.7 million, Cystadrops® (cysteamine hydrochloride) (€ 0.6 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 € 7.6 million (€ 10.3 million at 31 December 2020).

"Various revenue" includes € 26.1 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 finalized in January 2021 between Tolmar International Ltd. and Recordati S.p.A. for the assignment of the new product license. The first nine months of 2020 included € 19.5 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 these 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® 107,193 106,083 107,193 106,083
Zanipress® 31,307 38,234 31,307 38,234
Urorec® 45,265 58,488 45,265 58,488
Livazo® 31,849 42,450 31,849 42,450
Seloken®/Logimax® 72,991 77,699 72,991 77,699
Eligard® 59,362 59,362
Other corporate
products 118,713 120,303 118,713 120,303
Drugs for rare diseases 279,386 232,359 279,386 232,359
OTC 200,133 198,608 200,133 198,608
Local product
portfolios 166,146 174,345 166,146 174,345
Other revenue 8,413 7,317 8,413 7,317
Pharmaceutical
chemicals 35,431 37,932 35,431 37,932
Total net revenue 876,803 861,459 279,386 232,359 1,156,189 1,093,818

Geographic area by country

€ (thousands) Specialty and Specialty and Rare Rare Total Total
Primary Care Primary Care diseases diseases
2021 2020 2021 2020 2021 2020
Net pharmaceutical revenue
Italy 181,196 188,750 14,621 14,148 195,817 202,898
France 87,609 86,235 24,595 22,897 112,204 109,132
Russia, Ukraine, other CIS 59,752 66,719 3,695 2,370 63,447 69,089
Germany 96,708 87,495 15,019 13,100 111,727 100,595
Spain 75,807 54,414 10,048 8,665 85,855 63,079
Turkey 49,224 59,252 4,284 3,191 53,508 62,443
Portugal 32,050 31,313 1,430 1,244 33,480 32,557
Other Eastern European
countries 73,511 62,018 6,770 5,080 80,281 67,098
Other Western European
countries 54,627 46,268 21,244 20,596 75,871 66,864
North Africa 25,902 31,753 1,431 1,619 27,333 33,372
Other international sales 104,986 109,310 48,740 50,031 153,726 159,341
U.S.A. 127,509 89,418 127,509 89,418
Total net pharmaceutical
revenue 841,372 823,527 279,386 232,359 1,120,758 1,055,886
Net pharmaceutical chemicals
revenue
Italy 4,031 3,302 4,031 3,302
Other European countries 13,119 11,749 13,119 11,749
U.S.A. 4,031 4,225 4,031 4,225
America (U.S.A. excluded) 3,104 3,692 3,104 3,692
Australasia 9,732 13,844 9,732 13,844
Africa 1,414 1,120 1,414 1,120
Total net pharmaceutical
chemicals revenue 35,431 37,932 0 0 35,431 37,932
Total net revenue 876,803 861,459 279,386 232,359 1,156,189 1,093,818

4. OPERATING EXPENSES

Total operating expenses for the first nine months of 2021 amounted to € 783.3 million, up compared to the € 729.8 million for the corresponding period the previous year, and are classified by function as follows:

€ (thousands) First nine months
2021
First nine months
2020
Change
2021/2020
Cost of sales 313,005 308,237 4,768
Selling expenses 287,007 256,701 30,306
Research and development expenses 119,691 106,344 13,347
General and administrative expenses 60,057 53,644 6,413
Other (income)/expenses, net 3,502 4,855 (1,353)
Total operating expenses 783,262 729,781 53,481

The cost of sales was € 313.0 million, slightly up compared to the first nine months of 2020. The impact on revenue was 27.1%, lower than the 28.2% in the first nine months 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 11.8% compared to the first nine months 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. Marketing expenses also increased, mainly due to the launch of Isturisa®.

Research and development expenses were at € 119.7 million, increasing by 12.6% over the first nine months 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 12.0% 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 following table summarizes the more significant components of "Other net (income)/expenses".

€ (thousands) First nine
months 2021
First nine
months 2020
Change
2021/2020
Non‐recurring costs for the COVID‐19 epidemic 1,822 5,182 (3,360)
Other 1,680 (327) 2,007
Other (income)/expenses, net 3,502 4,855 (1,353)

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 nine months
2021
First nine months
2020
Change
2021/2020
Material consumption 238,038 231,297 6,741
Payroll costs 201,494 185,963 15,531
Other employee costs 21,624 21,618 6
Variable sales expenses 80,488 61,767 18,721
Depreciation and amortization 72,896 69,582 3,314
Utilities and consumables 27,181 26,528 653
Other expenses 141,541 133,026 8,515
Total operating expenses 783,262 729,781 53,481

The proportion of raw material consumption to net revenue was 20.6%, down compared to the 21.1% of the same period in 2020.

The item "Payroll costs" includes stock option plan expenses totalling € 3.6 million, in line with the same period the previous year.

As from 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 September 2021 determined an expense in the income statement of € 0.8 million.

Amortization items equalled € 72.9 million, of which, € 54.0 million related to intangible assets, increasing by € 3.4 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 € 18.9 million relating to property, plant and equipment, down by € 0.1 million on the first nine months of 2020.

5. NET FINANCIAL INCOME AND EXPENSES

In the first nine months of 2021 and same period in 2020, the balance of financing items was negative for € 22.2 million and € 11.2 million, respectively. The main balance items are summarized in the table below.

€ (thousands) First nine months First nine months Change
2021 2020 2021/2020
Interest expense on loans 12,605 12,188 417
Net exchange rate (gains)/losses 6,753 (600) 7,353
Net (income)/expense on short‐term positions 2,211 (1,282) 3,493
Expenses on leases 591 828 (237)
Expenses for defined benefit plans 31 58 (27)
Total net financial (income)/expenses 22,191 11,192 10,999

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 nine months 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 € 54.4 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 € 24.4 million compared to the first nine months of 2020, mainly 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 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 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 recognized 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 amortizations, 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 recognized 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 nine months of 2021, totalling € 6.2 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 1,522 2,481 4,695 11,640 20,338
Disposals (1,086) (1,914) (3,803) (135) (6,938)
Other changes (155) 4,484 742 (6,961) (1,890)
Balance at 30 September 2021 91,211 246,628 100,346 26,361 464,546
Accumulated amortization
Balance at 31 December 2020 51,670 200,268 67,848 0 319,786
Amortization for the period 4,470 6,228 8,240 0 18,928
Disposals (1,017) (1,904) (3,759) 0 (6,680)
Other changes (26) (435) (19) 0 (480)
Balance at 30 September 2021 55,087 204,157 72,310 0 331,554
Net amount
31 December 2020 39,260 41,309 30,864 21,817 133,250
30 September 2021 36,124 42,471 28,036 26,361 132,992

Increases over the period, totalling € 20.3 million, refer mainly to the Parent Company (€ 13.5 million) and the subsidiaries Recordati Pharma GmbH (€ 0.8 million), Recordati Ireland (€ 0.7 million), Recordati Polska (€ 0.7 million) and Opalia Pharma (€ 0.7 million).

"Other changes" includes the conversion into euro of the property, plant and equipment recognized in different currencies, for a net decrease of € 1.4 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 1,215 353 3,495 5,063
Disposals (1,086) (5) (3,088) (4,179)
Other changes 136 0 (198) (62)
Balance at 30 September 2021 20,884 1,430 20,070 42,384
Accumulated amortization
Balance at 31 December 2020 6,684 188 8,255 15,127
Amortization for the period 2,816 162 4,486 7,464
Disposals (1,017) (5) (3,053) (4,075)
Other changes 29 0 (103) (74)
Balance at 30 September 2021 8,512 345 9,585 18,442
Net amount
31 December 2020 13,935 894 11,606 26,435
30 September 2021 12,372 1,085 10,485 23,942

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 574 50,287 278 10,136 61,275
Disposals (1) (17) (3) 0 (21)
Other changes 5,946 3,072 226 (785) 8,459
Balance at 30 September
2021 1,035,854 557,491 21,152 57,787 1,672,284
Accumulated amortization
Balance at 31 December 2020 253,685 214,572 18,503 0 486,760
Amortization for the period 34,512 19,041 415 0 53,968
Disposals (1) (17) (3) 0 (21)
Other changes 3,153 423 (35) 0 3,541
Balance at 30 September
2021 291,349 234,019 18,880 0 544,248
Net amount
31 December 2020 775,650 289,577 2,148 48,436 1,115,811
30 September 2021 744,505 323,472 2,272 57,787 1,128,036

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;
  • € 9.0 million referring to clinical studies that comply with the criteria set by the IAS 38 accounting standard on capitalisation.

"Other changes" includes the conversion into euro of the value of the intangible assets held and recognized in different currencies, which was a net increase of € 4.8 million compared to 31 December 2020, mainly attributable to the revaluation of the U.S. dollar for € 3.8 million and the Russian rouble for € 1.1 million.

9. GOODWILL

Net goodwill at 30 September 2021 amounted to € 560.3 million, a decrease of € 1.8 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 € 25.0 million;
  • Germany for € 48.8 million;
  • Portugal for € 32.8 million;
  • Treatments for rare diseases: 110.6 million;
  • Turkey for € 24.2 million;
  • Czech Republic for € 13.9 million;
  • Romania for € 0.2 million;
  • Poland for € 14.2 million;
  • Spain for € 58.1 million;
  • Tunisia for € 16.6 million:
  • Italy for € 133.2 million;
  • Switzerland for € 8.5 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 € 1.8 million attributable to the acquisitions made in Turkey (decrease of € 3.1 million), Poland (decrease of € 0.2 million), Tunisia (increase of € 0.1 million), Czech Republic (increase of € 0.4 million) and Russia (increase of € 1.0 million).

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

10. OTHER EQUITY INVESTMENTS AND SECURITIES

At 30 September 2021, these amounted to € 42.0 million, down by € 3.6 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 September 2021, the total fair value of the 9,554,140 shares held was € 39.7 million. The value of the investment was consequently adjusted to the stock exchange value and fell by € 2.8 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 € 2.2 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 € 0.9 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 September 2021, this item came to € 31.9 million, up by € 25.1 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 September 2021, deferred tax assets amounted to € 76.2 million, recording a net increase of € 1.1 million compared to 31 December 2020.

13. CURRENT ASSETS

Inventories amounted to € 244.5 million, down by € 6.8 million compared to 31 December 2020.

Trade receivables amounted to € 300.8 million at 30 September 2021, up by € 31.9 million compared to 31 December 2020. The balance is less the provision for € 15.0 million, in line with 31 December 2020, recognized under selling expenses, which reflects the collection risk connected with certain customers and geographic areas. Average days sales outstanding are 67.

Other receivables amounted to € 44.9 million, down by € 2.4 million compared to 31 December 2020.

Other current assets were at € 15.0 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 € 9.7 million asset at 30 September 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 € 6.5 million, and that hedging the US\$ 25 million tranche of the loan, provided by UniCredit, yielded a € 3.2 million positive change.

At 30 September 2021, other hedging transactions were in place on foreign currency positions, the measurement of which was positive for a total of € 1.3 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 September 2021, the balance of this item amounted to € 341.9 million, increasing by € 153.7 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 September 2021 was € 1,445.1 million, an increase of € 168.8 million compared to 31 December 2020 due to the combined effect of the following reasons:

  • increase of € 296.4 million from income for the period;
  • increase of € 3.6 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 € 37.9 million from the disposal of 1,569,000 treasury shares to service the stock option plans;
  • increase of € 1.1 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 € 3.4 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 € 12.1 million for foreign currency translation adjustments;
  • increase of € 1.0 million from other changes;
  • decrease of € 113.0 million from the distribution of the dividend balance.

The remaining 1% of the share capital in the Italian subsidiary Recordati Rare Diseases Italy was acquired in July, bringing the shareholding to 100%. Consequently, the portion of shareholders' equity is no longer recognized under non‐controlling interests.

At 30 September 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, over four tranches, starting from the second year in the case of the less recent grants, and three years for the 2021 grant, payable in a single tranche. They expire 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.

Total 6,207,000 3,219,500 (1,569,000) (89,500) 7,768,000
6 May 2021 45.97 3,219,500 3,219,500
3 August 2018 30.73 3,841,000 (712,500) (85,000) 3,043,500
13 April 2016 21.93 1,587,500 (564,500) (4,500) 1,018,500
29 July 2014 12.29 778,500 (292,000) 486,500
Grant date
Strike price
(€)
Quantity
1/1/2021
Granted
2021
Exercised in
2021
Cancelled and
expired 2021
Quantity
30.9.2021

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

At 30 September2021, 2,760,302 treasury shares were held in the portfolio, a decrease of 69,000 shares compared to 31 December 2020. The change was due to the disposal of 1,569,000 shares for an amount of € 37.9 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 € 98.9 million, with an average unit price of € 35.84.

As from 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 September 2021, loans amounted to € 1,052.9 million, increasing by a net € 4.4 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 € 24.2 million, a net decrease of € 2.5 million compared to 31 December 2020.

In the first nine months of 2021, new bank loans were taken out for 219.1 million and new lease contracts were signed for € 5.1 million, whereas a total of € 223.6 million was repaid, of which € 7.2 million related to lease liabilities. The € 25.0 million loan from Banca Nazionale del Lavoro was repaid on the expiry of the contract in March, with the payment of the last instalment of € 6.3 million. In September, the loan for € 50.0 million undertaken in 2017 with UniCredit was extinguished with a single repayment. 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 € 3.8 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 instalment repayment on maturity. Disbursement, net of structuring and up‐front 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 September 2021 was € 48.5 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 September 2021 amounted to a total of € 317.3 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 semi‐ annual repayments of principal starting November 2020 through November 2023. The debt outstanding at 30 September 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 September 2021, the fair value of the derivative was measured at negative € 1.3 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 instalments on 30 June and 31 December 2021. The debt outstanding at 30 September 2021 amounted to a total of € 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 debt outstanding at 30 September 2021 amounted to a total of € 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 September 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 September 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 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 7 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 September 2021, the fair value of the derivative was measured at negative € 0.3 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 € 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 September 2021 amounted to € 33.0 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 September 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) 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 instalments 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.

l) 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 September 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 September 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.

m) 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 September 2021 amounted to € 1.1 million, down by € 1.1 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.

n) 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 September 2021 resulted in an increased liability for € 3.7 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 September 2021, hedging instruments measured at fair value were positive for a total of € 9.7 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 September 2021, this item amounted to € 21.4 million and reflects the Group's liability towards its employees determined in accordance with IAS 19.

19. DEFERRED TAX LIABILITIES

At 30 September 2021, deferred tax liabilities amounted to € 27.8 million, a sharp decrease of € 13.4 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 September 2021, the balance for other liabilities recorded under non‐current liabilities was zero following the reclassification of future payments to Novartis AG under current liabilities, related to the marketing of Isturisa® in certain European markets.

21. CURRENT LIABILITIES

Trade payables at € 166.9 million, included the accrual for invoices to be received.

Other liabilities amounted to € 133.1 million, increasing by € 37.4 million compared to 31 December 2020, and mainly include:

  • € 42.9 million due to employees and social security institutions;
  • € 38.4 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®;
  • € 9.0 million which Recordati Rare Diseases Inc. must pay to U.S. health care insurance schemes;

  • € 2.1 million to be paid to the "Krankenkassen" (German health insurance schemes) by Recordati Pharma GmbH;

  • € 3.4 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;
  • € 3.4 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 € 40.2 million, in line with the amount at 31 December 2020.

Other current liabilities amounted to € 8.4 million, down by € 2.8 million compared to 31 December 2020. An amount of € 7.6 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 instalments based on the fulfilment of the conditions for revenue recognition.

The provisions for risks and charges amounted to € 14.2 million, down by € 2.9 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 September 2021 of the interest rate swaps hedging a number of loans gave rise to a total € 3.0 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 (€ 1.8 million) and Intesa Sanpaolo (€ 1.2 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 September 2021 on the outstanding loan of 182.7 million Swiss francs was a negative € 2.1 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 September 2021, other hedging transactions were in place on foreign currency positions, with the measurement negative for a total of € 1.0 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 September 2021 were € 13.5 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 September 2021 and include comparative data.

€ (thousands) Specialty and
Primary Care
segment
Rare diseases
segment
Values not
allocated
Consolidated
financial
statements
First nine months 2021
Net revenue 876,803 279,386 1,156,189
Expenses (611,308) (171,954) (783,262)
Operating income 265,495 107,432 372,927
First nine months 2020
Net revenue 861,459 232,359 1,093,818
Expenses (594,043) (135,738) (729,781)
Operating income 267,416 96,621 364,037
€ (thousands) Specialty and
Primary Care
Rare diseases
segment
Values not
allocated*
Consolidated
financial
segment statements
30 September 2021
Non‐current assets 1,182,727 746,740 41,963 1,971,430
Inventories 196,344 48,157 244,501
Trade receivables 228,485 72,284 300,769
Other receivables and other current
assets 42,036 17,862 11,021 70,919
Short‐term financial investments,
cash and cash equivalents 341,926 341,926
Total assets 1,649,592 885,043 394,910 2,929,545
Non‐current liabilities 43,446 5,692 824,701 873,839
Current liabilities 226,610 136,256 247,772 610,638
Total liabilities 270,056 141,948 1,072,473 1,484,477
Net capital employed 1,379,536 743,095
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. The market context is gradually improving with the easing of the restrictions introduced to counter the COVID‐19 epidemic.

28. SUBSIDIARIES INCLUDED IN THE CONSOLIDATED ACCOUNTS AT 30 SEPTEMBER 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
RECORDATI (BEIJING) PHARMACEUTICAL CO., Ltd (1)
Marketing of pharmaceuticals
People's Republic
of China
1,000,000.00 EUR Line‐by‐line

(1) Set up in 2021

PERCENTAGE OF OWNERSHIP
Consolidated companies Recordati
S.p.A. Parent
Company
Recordati
Pharma
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.
100.00 100.00
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
S.p.A. Parent
Company
Recordati
Pharma
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
RECORDATI (BEIJING)
PHARMACEUTICAL CO., Ltd (1)
100.00 100.00

(1) Set up in 2021

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

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

Milan, 28 October 2021

Luigi La Corte

Financial Reporting Manager

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