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Recordati Industria Chimica e Farmaceutica

Quarterly Report Nov 9, 2022

4056_rns_2022-11-09_1c005558-7a12-4918-b026-148c1798696b.pdf

Quarterly Report

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INTERIM REPORT

AT 30 SEPTEMBER 2022

CONTENTS

Page
MANAGEMENT REVIEW 3
Financial highlights 3
Corporate development news and other key events 6
Review of operations 8
Financial review 14
Business outlook 19
CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2022 and NOTES 20
DECLARATION BY THE MANAGER RESPONSIBLE FOR PREPARING
THE COMPANY'S FINANCIAL REPORTS
57

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 activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising.

MANAGEMENT REVIEW

FINANCIAL HIGHLIGHTS ‐ First nine months 2022

NET REVENUE

€ (thousands) First nine months
2022
% First nine
months 2021
% 0B0B0BChanges
2022/2021
%
Total net revenue 1,377,542 100.0 1,156,189 100.0 221,353 19.1
Italy 210,054 15.2 201,603 17.4 8,451 4.2
International 1,167,488 84.8 954,586 82.6 212,902 22.3

KEY CONSOLIDATED P&L DATA

€ (thousands) First nine First nine 0B0B0BChanges
months 2022 % of months 2021 % of 2022/2021 %
revenue revenue
Net revenue 1,377,542 100.0 1,156,189 100.0 221,353 19.1
EBITDA(1) 516,154 37.5 447,886 38.7 68,268 15.2
Operating income 355,881 25.8 372,927 32.3 (17,046) (4.6)
Adjusted operating income
(2)
423,741 30.8 374,990 32.4 48,751 13.0
Net income 241,458 17.5 296,386 25.6 (54,928) (18.5)
Adjusted net income (3) 355,870 25.8 313,429 27.1 42,441 13.5

KEY CONSOLIDATED BALANCE SHEET DATA

€ (thousands) 30 September
2022
31 December
2021
0B0B0BChanges
2022/2021
%
Net financial position(4) (1,336,881) (736,539) (600,342) 81.5
Shareholders' equity 1,610,472 1,381,625 228,847 16.6

(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, non‐recurring items and non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(2) Net income before income taxes, financial income and expenses and non‐recurring items, non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(3) Net income excluding the amortization and write‐down of intangible assets (except software) and goodwill, non‐recurring items, non‐ cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory pursuant to IFRS 3, and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.

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

Third quarter 2022

NET REVENUE

€ (thousands) Third quarter Third quarter 0B0B0BChanges
2022 % 2021 % 2022/2021 %
Total net revenue 485,052 100.0 385,354 100.0 99,698 25.9
Italy 63,746 13.1 61,536 16.0 2,210 3.6
International 421,306 86.9 323,818 84.0 97,488 30.1

KEY CONSOLIDATED P&L DATA

€ (thousands) Third quarter
2022
% of
revenue
Third quarter
2021
% of
revenue
0B0B0BChanges
2022/2021
%
Net revenue 485,052 100.0 385,354 100.0 99,698 25.9
EBITDA(1) 181,258 37.4 147,436 38.3 33,822 22.9
Operating income 123,584 25.5 122,559 31.8 1,025 0.8
Adjusted operating income
(2)
148,204 30.6 123,046 31.9 25,158 20.4
Net income 90,053 18.6 89,280 23.2 773 0.9
Adjusted net income (3) 131,104 27.0 103,610 26.9 27,494 26.5

(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, non‐recurring items and non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(2) Net income before income taxes, financial income and expenses and non‐recurring items, non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(3) Net income excluding the amortization and write‐down of intangible assets (except software) and goodwill, non‐recurring items, non‐ cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory pursuant to IFRS 3, and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.

In the first nine months of 2022 the Group achieved very positive financial results, with revenue and operating profits above expectations, thanks to the continued recovery of the pharmaceutical market, but mainly thanks to the robust performance of our main products.

Consolidated net revenue in the first nine months of 2022 was € 1,377.5 million, up by 19.1% compared to € 1,156.2 million in the same period of the previous year and includes € 91.1 million in revenue from the rare and niche oncology product portfolio acquired with EUSA Pharma, consolidated since the second quarter. Net of the new acquisition and the effect of the progressive switch to direct sales of Eligard® in the first half of 2021, organic revenue growth was 10.4%, which reflects broadly neutral FX year on year of ‐0.1% (‐€1.7 million), with the strong devaluation of the Turkish lira being almost entirely offset by the rise in the U.S. dollar and the rouble.

Both sectors of the Group contributed to the growth. With regard to the Specialty and Primary Care business, significant growth was recorded in seasonal flu products, which in the first half of 2021 had also been affected by the general reduction in inventories particularly in Russia, and in gastrointestinal and urology products. The contribution of Eligard®, licensed from Tolmar International Ltd in January 2021, was also greater compared to the same period in 2021. Regarding the rare diseases business, as well as the contribution of the new products acquired with the EUSA Pharma acquisition endocrinology products saw continued growth (Signifor® and Isturisa®), as did metabolic products, in particular in the United States, driven by Panhematin® and Cystadrops®, with resilient sales of Carbaglu®.

As noted in the Half‐yearly Report, in April 2022 the conditions were fulfilled for application of the accounting standard IAS 29 "Financial Reporting in Hyperinflationary Economies" in Turkey. The application of the standard as of 1 January 2022 led to an increase in revenue of € 5.4 million but determined a negative impact on operating income, EBITDA and net income, as described in more detail below. Also from the second quarter of 2022, given the materiality of the non‐monetary adjustments originating from the allocation under standard IFRS3 of the higher price paid for the acquisition of EUSA Pharma, in line with the best practices of the sector and to provide a disclosure that is as thorough as possible on the Group's operating performance (and comparable with the previous period), two new indicators were inserted: Adjusted gross profit and adjusted operating income. Both these indicators are adjusted for the related impacts of applying the standard IFRS 3 as well as, in the case of adjusted operating income, for non‐recurring items.

Gross profit was € 954.7 million, with a ratio to sales of 69.3%, up 13.2% compared to the same period of the previous year. This result reflects the revaluation of the EUSA Pharma inventories acquired according to the provisions of the accounting standard IFRS 3, with an effect on the income statement, calculated on the basis of the units sold in the period, amounting to € 35.6 million. Net of this effect, the adjusted gross profit was € 990.4 million, up by 17.5%, with an increase in revenue partially offset by a dilutive effect due to the gradual shift to the direct sales model of Eligard® in the first half of 2021. To note, impact of the application of IAS 29 at the level of Gross Profit was approximately € 6 million.

Adjusted operating income was € 423.7 million, up 13.0% over the same period of the previous year, with a ratio of 30.8%, with strong revenue growth in part offset by return of activities in the field. Operating income was € 355.9 million, down 4.6% over the same period of the previous year, with a ratio to revenue of 25.8%. In addition to the charges arising from the fair value adjustment of the acquired EUSA Pharma inventory mentioned above, operating income reflects € 32.2 million of planned non‐recurring costs, of which around € 19.2 million mainly related to the acquisition of EUSA Pharma, approximately € 11.1 million for actions to improve the efficiency of the sales force in the Specialty & Primary Care segment, in addition to donations to Ukraine.

EBITDA, at € 516.2 million, increased by 15.2% compared to the first nine months of 2021 and with a ratio to revenue of 37.5%, and reflects the increase in revenue and the benefit of the actions to sustain margins, including the efficiency improvement measures aimed at organizing the Specialty and Primary Care sector sales force, mainly in Germany and Turkey, which began in 2021 and were extended to Italy in 2022. The robust performance of EBITDA also absorbed the negative impact of approximately € 7 million from the application of IAS 29 in Turkey.

Net income at € 241.5 million, was down 18.5% compared with the first nine months of 2021. Despite the extremely positive trend of the Group's operating results, the decrease is due to the material non‐recurring costs and IFRS 3 adjustments mentioned above and the higher incidence of financial charges, which include € 5.6 million of monetary net losses from IAS 29 adjustments and € 18.2 million of FX losses (compared to losses of € 6.8 million in the first nine months of 2021). These losses, mostly unrealised, were mainly determined by the significant revaluation of the Russian rouble and the US dollar against the euro, in particular in the second quarter of 2022.

Adjusted net income was € 355.9 million, up 13.5% compared to the same period in 2021, at 25.8% of revenue.

The net financial position at 30 September 2022 recorded net debt of € 1,336.9 million compared to net debt of € 736.5 million as of 31 December 2021. The significant increase is mainly attributable to the cash‐out of € 707.0 million to acquire EUSA Pharma, which was completed on 16 March 2022, and to the acquired net debt of € 28.4 million. During the period € 35.0 million was paid to Tolmar International Ltd. related to the development of a new device to make administration of Eligard® easier, 24.0 million US dollars to Novartis, of which 14.0 million in the context of the agreements for the transfer of the assets related to Signifor® LAR microparticle production phase and € 5.0 million in the context of the licence agreements with Helsinn for Ledaga®. Furthermore, treasury

shares were purchased for € 30.0 million, net of sales proceeds from exercising stock options, and dividends were paid for € 120.0 million.

Free cash flow in the period was € 346.3 million, down € 6.6 million compared to the first nine months of 2021 due to charges related to the acquisition of EUSA Pharma and the organisational restructuring of the Specialty & Primary Care segment.

Thanks to excellent operating results and strong cash generation, which also absorbed significant non‐recurring costs, the Group's net debt to EBITDA ratio as of 30 September was just below 2.

Shareholders' equity was € 1,610.5 million.

CORPORATE DEVELOPMENT NEWS AND OTHER KEY EVENTS

The acquisition of EUSA Pharma (UK) Limited was completed on March 16th, 2022. This specialist global pharmaceutical company based in the United Kingdom, focuses on niche rare and oncology diseases. The acquisition of EUSA Pharma is an additional and significant step forward in achieving our strategy, which aims to increase our presence in the rare diseases segment and implement our mission: improving patients' lives by delivering innovative treatments that address serious unmet medical needs. The transaction integrates Recordati's global presence with new expertise and a highly efficient and focused commercial infrastructure, adding a product portfolio of four drugs with high growth potential for the treatment of niche rare cancers and providing a platform for possible future expansion. The consolidation of the opening balances of EUSA Pharma in the Recordati group occurred with reference to the date of 31 March 2022, taking into account the fair value adjustments resulting from the Purchase Price Allocation process, with recognition in the item "Goodwill" of the difference between the acquisition cost and the fair value of the assets and liabilities acquired. As permitted by the accounting standard IFRS 3, this valuation process should be considered still provisional, considering the limited period that has passed since the completion of the acquisition operation. Income statement results have been consolidated as from the second quarter of 2022, contributing strongly to the Group's results.

Pursuant to the license and supply agreements signed in January 2021 with Tolmar International Ltd to market Eligard® (leuprorelin acetate) in Europe, Turkey, Russia, and other countries, following a request from the European Medicines Agency (EMA), a new device was developed to make administration of the product easier. The application for approval was submitted in the first quarter of 2022 and subsequently accepted by the authority. 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. The active ingredient in Eligard®, leuprorelin acetate, presents in powder form, which is solubilized with a solvent and administered as a subcutaneous injection. Based on the agreements signed, a milestone of € 35 million was paid to Tolmar International Ltd in second quarter of 2022 on acceptance of the application. On 22 September 2022 the Reference Member State (Germany) approved the variation regarding the new device to administer Eligard®, and the procedures to transpose the approval into national law began as of this date. The payment to Tolmar International Ltd of a milestone of € 70 million is linked to the conclusion of the national registration phase in certain countries and the fulfilment of other contractual conditions.

On 30th September 2022, following the acquisition of the rights for Signifor® LAR completed in October 2019 and the issue of the required authorization by the competent Swiss regulatory authority, our subsidiary Recordati AG finalised the transfer from Novartis Pharma of the assets related to the Signifor® LAR microparticle production phase conducted in Novartis manufacturing plant in Basel, with payment of the residual milestone due. The transfer of control of the assets and of the associated risks to Recordati AG is effective from 1st October 2022.

Our focus and efforts in driving our ESG strategy have been further recognized, by the FTSE4GOOD Index series inclusion reconfirmation and the increase rating from "Gold" to "Platinum" by EcoVadis. Furthermore, the A rating awarded by MSCI was confirmed and, in September 2022, our total ESG coverage was declared "Robust" according to the analysis by Moody's ESG Solutions.

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 2022 was € 1,377.5 million, compared to € 1,156.2 million in the same period of the previous year (+19.1% or +19.3% at constant exchange rate) and included the net revenue of EUSA Pharma, amounting to € 91.1 million. The trend in revenue reflects the effect of the recovery in relevant markets from the effects of the COVID‐19 pandemic (which was particularly significant for seasonal flu products) and the continued growth in the portfolio of products for the treatment of rare diseases.

Breakdown of revenue Revenue by geographic area

* Excluding sales of pharmaceutical chemicals, which were at € 35.9 million, increasing by 1.3%, representing 2.6% of total revenue.

The performance of products sold directly in more than one market (corporate products) during the first nine months of 2022 is shown in the table below.

€ (thousands) First nine months
2022
First nine months
2021
Changes
2022/2021
6B6B4B%
Zanidip® (lercanidipine) 103,410 107,193 (3,783) (3.5)
Zanipress® (lercanidipine+enalapril) 28,526 31,307 (2,781) (8.9)
Urorec® (silodosin) 46,183 45,265 918 2.0
Livazo® (pitavastatin) 35,708 31,849 3,859 12.1
Seloken®/Seloken® ZOK/Logimax®
(metoprolol/metoprolol + felodipine)
72,512 72,991 (479) (0.7)
Eligard® (leuprorelin acetate) 78,640 59,362 19,278 32.5
Other corporate products* 230,667 198,059 32,608 16.5
Drugs for rare diseases 429,791 279,386 150,405 53.8
of which endocrinology
products
126,631 90,509 36,122 39.9
of which "niche oncology" 91,141 91,141 n.s.

* Include corporate OTC products for a total of € 94.3 million in 2022 and € 79.3 million in 2021 (+18.9%).

Zanidip® is a specialty containing lercanidipine, Recordati's original calcium channel blocker for the treatment of hypertension. Our lercanidipine‐based products are sold directly to the market by our 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
2022
First nine months
2021
Changes
2022/2021
8B8B6B%
Direct sales 56,105 53,661 2,444 4.6
Sales to licensees 47,305 53,532 (6,227) (11.6)
Total lercanidipine sales 103,410 107,193 (3,783) (3.5)

Direct sales of lercanidipine products were up compared to the same period of the previous year, mainly thanks to growth in the United Kingdom, Germany and Portugal, and partially offset by the reduction in Turkey due to the exchange rate effect and the reduction in prices due to competition from generic products. Sales to licensees, representing 45.7% of the total, decreased by 11.6% due to the distributor in China losing a tender (whereas the initial sales to the new distributor were recorded during the same period the previous year) and are recovering in the third quarter of 2022 compared to the same period of the previous year.

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 54 countries.

Direct sales of Zanipress® in the first nine months of 2022 were down by 6.5%, mainly due to the effect of the exchange rate in Turkey and lower volumes in Italy, whereas sales to licensees (representing 9.9% of the total), were impacted by the distributor in China's loss of a tender.

Urorec® (silodosin) is a specialty indicated for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). Currently, the product is marketed in 45 countries, and in the first nine months of 2022, sales amounted to € 46.2 million, up by 2.0% owing mainly to the growth in Russia.

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 € 35.7 million in the first nine months of 2022, up by 12.1% due to the increase in volumes, particularly in Russia, Switzerland and higher sales to licensees.

The stabilisation of sales of silodosin and the return to growth of sales of pitavastatin show once again the Group's ability to manage mature products in an effective way after the loss of exclusivity.

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 € 72.5 million in the first nine months of 2022, down by 0.7% compared to the same period of the previous year due to lower volumes in Poland, Germany and Lithuania, not completely offset by growth in Romania and the Czech Republic. However, there was growth in the third quarter compared to the same period of the previous year.

Revenue for Eligard® in the first half of 2022 was € 78.6 million, up by 32.5% compared to the same period of the previous year. This increase was in part due to the different marketing method: while in 2022 revenue was almost all derived from direct sales made by Recordati, in the first half of 2021 it was mainly made up of the transfer to Recordati of gross profit, made by the previous licensee Astellas. On a like for like basis, Eligard® revenue would be up compared to the previous year by € 8.4 million (+11.9%), demonstrating that Recordati's promotional activities have effectively stopped the negative trend in sales over recent years with a return to growth in Spain, France, Portugal and Italy.

In the first nine months of 2022, sales of other corporate products totalled € 230.7 million, up by 16.5% over the same period of the previous year, owing mainly to the strong growth of seasonal flu products, such as Polydexa® and Isofra®, and the OTC products of the Hexa line and of Casen Recordati. 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® gynecological disorders, Virirec® (alprostadil) and Fortacin® (lidocaine+prilocaine), for andrological disorders.

In the first nine months of 2022, sales of our specialties for the treatment of rare diseases, marketed directly in Europe, the Middle East, the U.S.A., Canada, Mexico and some countries in South America, Japan, Australia and through partners in other territories, totalled € 429.8 million, up by 53.8% thanks to the integration of the oncology products acquired with EUSA Pharma and the continued growth of sales of Signifor®, Signifor® LAR and Isturisa® (for a total of € 126.6 million, up by 39.9%), as well as growth in Panhematin®, Cystadrops® and other metabolic portfolio products, in particular in the United States. The net revenue related to the acquisition of EUSA Pharma amounted to € 91.1 million and was consolidated within the Group starting from April 2022, with an increase of 13% (on a pro forma basis) in the first nine months of 2022 compared to the same period of the previous year. Sylvant® and Qarziba® both performed extremely well.

Sales of pharmaceutical chemicals, which comprise active substances produced in the Campoverde di Aprilia plant in Italy for the international pharmaceutical industry, were at € 35.9 million, up by 1.3%, representing 2.6% of total revenue.

Sales of 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
2022
First nine months
2021
Changes
2022/2021
12B12B10B%
Italy 206,837 195,817 11,020 5.6
U.S.A. 190,748 127,509 63,239 49.6
France 126,153 112,204 13,949 12.4
Germany 123,937 111,727 12,210 10.9
Spain 104,545 85,855 18,690 21.8
Russia, other C.I.S. countries and
Ukraine
88,697 63,447 25,250 39.8
Turkey 59,945 53,508 6,437 12.0
Portugal 40,654 33,480 7,174 21.4
Other Western European countries 99,796 75,871 23,925 31.5
Other C.E.E. countries 94,805 80,281 14,524 18.1
North Africa 28,657 27,333 1,324 4.8
Other international sales 176,892 153,726 23,166 15.1
Total net pharmaceutical revenue* 1,341,666 1,120,758 220,908 19.7

*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
2022
First nine months
2021
Changes
2022/2021
13B14B%
United States of America (USD) 202,923 152,529 50,395 33.0
Russia (RUB) 5,210,023 4,040,288 1,169,735 29.0
Turkey (TRY) 906,717 478,682 428,035 89.4

Net revenue in Russia excludes sales of rare disease products.

Sales of pharmaceutical specialties in Italy were at € 206.8 million, increasing by 5.6% compared to the same period of the previous year. This was primarily due to the recovery in prescription seasonal flu and allergy medicines and the continual growth in OTC products, particularly Magnesio Supremo® in addition to growth in sales in products for the treatment of rare diseases, for € 17.9 million, up by 22.6%.

The Group's pharmaceutical business in the U.S.A. is dedicated to marketing products for the treatment of rare diseases. Sales were at € 190.7 million in the first nine months of 2022, up by 49.6%. In local currency sales increased by 33.0%, thanks also to the contribution of EUSA Pharma products for € 19.1 million. Growth was generated by endocrinology products (Signifor®, Signifor® LAR, Isturisa®) and products for metabolic disorders and other conditions (the main ones being Carbaglu®, Panhematin®, and Cystadrops®).

At € 126.2 million, sales in France were up by 12.4%. The country also benefited from the recovery in seasonal flu products and cardiovascular medications, with Reselip® marketed from April 2021, as well as the growth of Eligard®. Sales of products for the treatment of rare diseases amounted to € 26.6 million (+8.1%).

Sales in Germany were € 123.9 million and increased by 10.9% thanks to good growth of the Ortoton® product and to the contribution of Eligard®. Sales of medicines for the treatment of diseases were good, amounting € 26.8 million (+78.6%) thanks to the growth of the endocrinology portfolio and the contribution of the EUSA Pharma products.

Sales for € 104.5 million were recorded in Spain, up by 21.8%, mainly due to the contribution of Eligard®, gastrointestinal products and Flatoril®. Sales of drugs for the treatment of rare diseases amounted to € 16.9 million, up by 68.2% thanks also to the contribution of the EUSA Pharma product portfolio.

Sales generated in Russia, in the countries within the Commonwealth of Independent States (C.I.S.) and in Ukraine were € 88.7 million, up by 39.8% compared to the same period of the previous year, and include an estimated positive exchange rate effect of € 9.1 million. Revenue made in Russia was RUB 5,210.0 million in local currency, up by 29.0% over the same period of the previous year, while sales in Ukraine were UAH 286.1 million, with a 12.0% drop in terms of local currency. The increase of sales in Russia was due to the strong recovery of seasonal flu products and demand in general after the pandemic, but also reflects the trend of the first half of 2021, in which wholesalers, in particular in Russia, had instead implemented a policy of reducing inventory levels owing to the impact of the pandemic. Sales of products for the treatment of rare diseases in this area were at € 6.8 million (+84.1%).

Sales in Turkey were € 59.9 million, stable compared to the same period of the previous year, and included an adverse currency exchange rate effect estimated at € 34.8 million. In local currency sales of the branch in Turkey increased by 89.4% thanks to a significant increase in prices that occurred in March and July owing to the devaluation of the Turkish lira recorded over the last few years. Sales of products for the treatment of rare diseases amounted to € 6.7 million, up by 57.5% thanks to the contribution of the EUSA Pharma products. The effect of applying IAS 29 "Financial Reporting in Hyperinflationary Economies" to activities in Turkey determined a positive effect on sales revenue of € 5.4 million.

Sales in Portugal were at € 40.7 million, up by 21.4%, thanks to Eligard®, products for gastrointestinal conditions, and the growth of lercanidipine. Sales of drugs for the treatment of rare diseases amounted to € 2.4 million.

Sales in other Central and Eastern European countries, at € 94.8 million, include the sales from Recordati subsidiaries in Poland, the Czech Republic and Slovakia, Romania, Bulgaria and the Baltic Countries, in addition to sales of rare disease treatments in this area, as well as in Hungary. In the first nine months of 2022, overall sales increased by 18.1% thanks to the growth of Eligard® and cardiovascular products. Sales of products for the treatment of rare diseases in this area, amounting to € 15.1 million, increased by 123.7% compared to the first nine months of 2021 thanks above all to the strong contribution of sales of products for rare cancers acquired with EUSA Pharma and the growth in endocrinology products.

Sales in other countries in Western Europe were € 99.8 million, up 31.5% thanks to the growth of Eligard® and lercanidipine, as well as EUSA Pharma oncology products. They include the sales from Recordati subsidiaries in United Kingdom, Ireland, Greece, Switzerland, Nordic countries (Finland, Sweden, Denmark, Norway and Iceland) and in BeNelux. Sales of products for the treatment of rare diseases in this area, equal to € 37.5 million, were up by 76.6% thanks to the contribution of the new EUSA Pharma products.

Sales in North Africa were € 28.7 million, up by 4.8% compared to the same period of the previous year, and comprise the export revenue generated by Laboratoires Bouchara Recordati in these territories, in particular in

Algeria, and sales generated by Opalia Pharma, the Group's Tunisian subsidiary, and sales of products for the treatment of rare diseases. Sales growth in the region depends on the increase in sales of the latter. As regards sales in the Specialty & Primary Care segment, there was strong growth in the Opalia Pharma product portfolio, offset by a reduction in Laboratoires Bouchara's sales in Algeria.

Other international sales, for € 176.9 million, were up by 15.1% 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 increase in sales was driven by the growth of the product portfolio for the treatment of rare diseases (including the new EUSA Pharma acquisition).

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 2021:

€ (thousands) First nine
months 2022
% of
revenue
First nine
months 2021
% of
revenue
0B0B0BChange
2022/2021
%
Net revenue 1,377,542 100.0 1,156,189 100.0 221,353 19.1
Cost of sales (422,804) (30.7) (313,005) (27.1) (109,799) 35.1
Gross profit 954,738 69.3 843,184 72.9 111,554 13.2
Selling expenses (331,226) (24.0) (287,007) (24.8) (44,219) 15.4
Research and development
expenses
(155,700) (11.3) (119,691) (10.4) (36,009) 30.1
General and administrative
expenses
(80,542) (5.8) (60,057) (5.2) (20,485) 34.1
Other income/(expenses), net (31,389) (2.3) (3,502) (0.3) (27,887) n.s.
Operating income 355,881 25.8 372,927 32.3 (17,046) (4.6)
Financial income/(expenses), net (46,163) (3.4) (22,191) (1.9) (23,972) n.s.
Pre‐tax income 309,718 22.5 350,736 30.3 (41,018) (11.7)
Income taxes (68,260) (5.0) (54,350) (4.7) (13,910) 25.6
Net income 241,458 17.5 296,386 25.6 (54,928) (18.5)
Adjusted gross profit (1) 990,380 71.9 843,184 72.9 147,196 17.5
Adjusted operating income (2) 423,741 30.8 374,990 32.4 48,751 13.0
Adjusted net income (3) 355,870 25.8 313,429 27.1 42,441 13.5
EBITDA(4) 516,154 37.5 447,886 38.7 68,268 15.2

(1) Gross profit adjusted by the impact of non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(2) Net income before income taxes, financial income and expenses and non‐recurring items, non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(3) Net income excluding the amortization and write‐down of intangible assets (except software) and goodwill, non‐recurring items, non‐ cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory pursuant to IFRS 3, and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.

(4) Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, non‐recurring items and non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

Net revenue amounted to € 1,377.5 million, up by € 221.4 million compared to the first nine months of 2021. For a detailed analysis, please refer to the previous chapter "Review of Operations".

As noted above, given the materiality of the non‐monetary adjustments originating from the application of the standard IFRS 3 for the allocation of the higher price paid for the acquisition of EUSA Pharma, in the second quarter, two new figures were inserted: Adjusted gross profit and adjusted operating income.

Gross profit was € 954.7 million, with a ratio to sales of 69.3%, up 13.2% compared to the same period of the previous year, despite the impact of € 35.6 million from the application of the standard IFRS 3 on the warehouse stocks of EUSA Pharma. Net of this effect, the adjusted gross profit was € 990.4 million, up by 17.5%, with an increase in revenue partially offset by a dilutive effect due to the gradual shift to the direct sales model of Eligard® in the first half of 2021 and a slight increase in the cost of sales owing to the increase in raw material costs. The negative impact of approximately € 6 million from the application of IAS 29 "Financial Reporting in Hyperinflationary Economies" should also be noted.

Selling expenses increased by 15.4% due to the resumption in promotional activities compared to the same period of the previous year (which was still affected by the COVID‐19 pandemic), to the consolidation of the EUSA Pharma activities and to the increased resources needed to support the growth of endocrinology products. This increase was nonetheless partially offset by the benefits of the efficiency measures put in place at the end of 2021 with regard to the organization of the Specialty and Primary Care sector sales force, primarily in Germany and Turkey. Expenses as a percentage of revenue came down compared to the same period of the previous year due to a particularly positive revenue performance.

Research and development expenses were € 155.7 million, an increase of 30.1% compared to those in the first nine months of the previous year owing both to the integration of the EUSA Pharma expenses (including € 12.3 million of amortization of intangible fixed assets) and to the increase in investments in support of products for endocrinology.

General and administrative expenses increased by 34.1% owing to the integration of EUSA Pharma and the strengthening of the general coordination structure to support an increasingly complex portfolio resulting from recent acquisitions.

Net income and expenses amounted to € 31.4 million, compared to € 3.5 million in the first nine months of 2021. The increase was due to non‐recurring costs related to the acquisition of EUSA Pharma of € 19.2 million (including costs related to Tech Transfer for € 6.4 million) and to organisational restructuring for € 11.1 million (mainly right sizing the Specialty and Primary Care segment in Italy) and donations to the people of Ukraine.

Adjusted operating income was € 423.7 million, up 13.0% over the same period of the previous year, with a ratio of 30.8%, with strong revenue growth in part offset by return of activities in the field. Operating income was € 355.9 million, down 4.6% over the same period of the previous year, with a ratio to revenue of 25.8%. In addition to the charges arising from the fair value adjustment of the acquired EUSA Pharma inventory mentioned above, operating income reflects € 32.2 million of planned non‐recurring costs, of which around € 19.2 million mainly related to the acquisition of EUSA Pharma, approximately € 11.1 million for actions to improve the efficiency of the sales force in the Specialty & Primary Care segment, in addition to donations to Ukraine.

EBITDA* was € 516.2 million, up by 15.2% compared to the first nine months of 2021, accounting for 37.5% of revenue. The amortization items classified above amounted to € 90.2 million, of which € 70.5 million related to intangible assets, up by € 16.6 million over the same period of the previous year owing mostly to the acquisition of EUSA Pharma (€ 12.3 million), and € 19.7 million relating to property, plant and equipment, up by € 0.7 million over the first nine months of 2021.

The reconciliation of net income and EBITDA is reported below.

€ (thousands) First nine
months 2022
First nine months
2021
Net income 241,458 296,386
Income taxes 68,260 54,350
Financial income/(expenses), net 46,163 22,191
Non‐recurring operating expenses 32,218 2,063
Non‐cash charges from PPA inventory uplift 35,642
Adjusted operating income 423,741 374,990
Amortization and write‐downs 92,413 72,896
EBITDA* 516,154 447,886

* Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, non‐recurring items and non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

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

€ (thousands) First nine months
2022
First nine months
2021
Changes
2022/2021
10B10B8B%
Specialty and Primary Care segment 328,346 315,536 12,810 4.1
Rare diseases segment 187,808 132,350 55,458 41.9
Total EBITDA* 516,154 447,886 68,268 15.2

* Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, non‐recurring items and non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

The ratio of EBITDA* to revenue for the Specialty and Primary Care segment was 34.6% of EBITDA, while for the rare disease segment it was 43.7%, down compared to the previous periods owing to consolidation of the results of EUSA Pharma starting from the second quarter, which at the moment has lower margins.

Net financial charges were € 46.2 million, up by € 24.0 million compared to the same period of the previous year owing mainly to higher expenses of € 7.1 million on loans, to the new debt contracted for the acquisition of EUSA Pharma, to the higher net exchange losses of € 11.5 million (mostly unrealised, accrued following the revaluation of the Russian rouble and the US dollar, in particular from the end of the second quarter) and to losses arising from the application of IAS 29 in Turkey for € 5.6 million.

The tax rate on pre‐tax income is 22.0%, higher than that of the same period of the previous year which had benefited from a non‐recurring € 26.2 million, for € 12.9 million related to the transfer to the Parent Company of the ACE (Aiuto alla Crescita Economica ‐ Aid for Economic Growth) position of the subsidiary Rossini Investimenti S.p.A. following its incorporation into Recordati S.p.A. and for € 13.3 million to the effects of the revaluation of the Magnesio Supremo® trademark by the subsidiary Natural Point S.r.l. In continuing with the approach adopted in previous years, this result includes the tax benefit pertaining to the first nine months of 2022 relating to the Patent Box in Italy, which reduces tax for an amount of € 5.7 million.

Net income was € 241.5 million, with a ratio to revenue of 17.5%, down by 18.5% compared to the same period the previous year owing to lower operating income due to significant non‐recurring costs, to non‐cash charges mainly arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventories, and to higher net financial expenses.

Adjusted net income was € 355.9 million, up by 13.5%, and excludes amortization and write‐downs of intangible assets (except software) and goodwill for a total amount of € 71.5 million, non‐recurring items of € 32.2 million, non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory of € 35.6 million, and monetary net losses from hyperinflation of € 5.6 million (IAS 29), net of tax effects.

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

€ (thousands) First nine months
2022
First nine months
2021
Net income 241,458 296,386
Amortization and write‐downs of intangible assets
(excluding software)
71,502 52,748
Tax effect (14,238) (10,996)
Non‐recurring operating expenses 32,218 2,063
Tax effect (8,491) (554)
Non‐cash charges from PPA inventory uplift 35,642
Tax effect (6,772)
Monetary net (gains)/losses from hyperinflation 5,619
Tax effect (1,068)
Non‐recurring tax income (26,218)
Adjusted net income* 355,870 313,429

* Net income excluding the amortization and write‐downs of intangible assets (except software) and goodwill, non‐recurring items, non‐ cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory pursuant to IFRS 3, and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.

NET FINANCIAL POSITION

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

€ (thousands) 30 September
2022
31 December
2021
Change
2022/2021
%
Cash and cash equivalents 346,609 244,578 102,031 41.7
Short‐term debts to banks and other lenders (5,656) (8,657) 3,001 (34.7)
Loans ‐ due within one year(1) (277,828) (213,486) (64,342) 30.1
Leasing liabilities ‐ due within one year (9,138) (8,100) (1,038) 12.8
Short‐term financial position 53,987 14,335 39,652 n.s.
Loans ‐ due after one year (1) (1,376,481) (735,783) (640,698) 87.1
Leasing liabilities ‐ due after one year (14,387) (15,091) 704 (4.7)
Net financial position (1,336,881) (736,539) (600,342) 81.5

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

The net financial position at 30 September 2022 recorded debt of € 1,336.9 million compared to debt of € 736.5 million at 31 December 2021. The significant increase is mainly attributable to the disbursement of € 707.0 million to acquire EUSA Pharma, which was completed on 16 March 2022. The net financial position of EUSA Pharma was negative at the time of acquisition for around € 28.4 million, determined by cash and cash equivalents for € 53.2

million and a loan for € 78.2 million, which was fully repaid at the time the transaction was completed, and by leasing liabilities of € 3.4 million. During the period € 35.0 million was paid to Tolmar International Ltd. related to the development of a new device to make administration of Eligard® easier, 24.0 million US dollars to Novartis, of which 14.0 million in the context of the agreements for the transfer of the assets related to Signifor® LAR microparticle production phase and € 5.0 million in the context of the licence agreements with Helsinn for Ledaga®. Furthermore, treasury shares were purchased for € 30.0 million, net of sales proceeds from exercising stock options, and dividends were paid for € 120.0 million.

Free cash flow in the period was € 346.3 million, down € 6.6 million compared to the first nine months of 2021 due to charges related to the acquisition of EUSA Pharma and the organisational restructuring of the Specialty & Primary Care segment.

RELATED‐PARTY TRANSACTIONS

At 30 September 2022, 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 VII Limited.

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.

BUSINESS OUTLOOK

On 24th February 2022, the Company announced the following financial targets for 2022, which include the contribution from the newly acquired EUSA Pharma as from the second quarter of the year: revenue between € 1,720 million and € 1,780 million, EBITDA (1) between € 630 and € 660 million and adjusted net income (2) between € 450 and € 470 million.

Given the strong momentum of the business, the Company has revised upwards its full year 2022 guidance. The new guidance expects overall Revenue of around € 1,860 million, with EBITDA (1) of around € 670 million and Adjusted Net Income(2) of around € 460 million.

These results include slightly dilutive effect of Turkey IAS 29 application (expected impact of +€15 million on Revenue and ‐€8 million on EBITDA).

Non‐recurring costs, which are not included in EBITDA(1) or Adjusted net income(2), are still estimated at approximately € 40 million, with acceleration of right sizing in SPC. Non‐monetary adjustments originating from the application of the standard IFRS 3 for the purchase price allocation of EUSA Pharma, are estimated for 2022 (Q2‐Q4) as approximately €20 million for intangible amortization and approximately €50 million for the revaluation at fair value of the inventories acquired. Financial expenses are now expected at around € 60 million, due to enduring strength of RUB and assuming around € 10 million of net monetary losses from IAS 29.

Milan, 8 November 2022

for the Board of Directors Chief Executive Officer Robert Koremans

(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, non‐recurring items and non‐cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.

(2) Net income excluding the amortization and write‐downs of intangible assets (except software) and goodwill, non‐recurring items, non‐ cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory pursuant to IFRS 3, and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.

CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2022 AND NOTES

RECORDATI S.p.A. and SUBSIDIARIES

CONSOLIDATED INCOME STATEMENT

€ (thousands)(1) Note First nine months
2022
First nine
months 2021
Net revenue 3 1,377,542 1,156,189
Cost of sales 4 (422,804) (313,005)
Gross profit 954,738 843,184
Selling expenses 4 (331,226) (287,007)
Research and development expenses 4 (155,700) (119,691)
General and administrative expenses 4 (80,542) (60,057)
Other income/(expenses), net 4 (31,389) (3,502)
Operating income 355,881 372,927
Financial income/(expenses), net 5 (46,163) (22,191)
Pre‐tax income 309,718 350,736
Income taxes 6 (68,260) (54,350)
Net income 241,458 296,386
Attributable to:
Equity holders of the Parent 241,458 296,386
Non‐controlling interests 0 0
Earnings per share (euro)
Basic 1.174 1.439
Diluted 1.155 1.417

(1) Except amounts per share.

Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,637,085 in 2022 and 205,919,516 in 2021. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,488,071 shares in 2022 and 3,205,640 shares in 2021.

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

CONSOLIDATED BALANCE SHEET

ASSETS

€ (thousands) Note 30
September
2022
31
December
2021
Non‐current assets
Property, plant and equipment 7 147,226 131,120
Intangible assets 8 1,714,511 1,138,786
Goodwill 9 707,709 553,209
Other equity investments and securities 10 26,972 34,124
Other non‐current assets 11 55,526 32,937
Deferred tax assets 12 83,358 75,922
Total non‐current assets 2,735,302 1,966,098
Current assets
Inventories 13 403,981 228,732
Total current assets 1,242,552 850,101
Cash and cash equivalents 15 346,609 244,578
Derivative instruments measured at fair value 14 31,421 11,149
Other current assets 13 17,479 12,984
Other receivables 13 49,625 44,880
Trade receivables 13 393,437 307,778
Total assets 3,977,854 2,816,199

CONSOLIDATED BALANCE SHEET

SHAREHOLDERS' EQUITY AND LIABILITIES

€ (thousands) Note 30 September
2022
31 December
2021
Shareholders' equity
Share capital 26,141 26,141
Share premium reserve 83,719 83,719
Treasury shares (149,782) (126,981)
Reserve for derivative instruments 3,193 (974)
Translation reserve (114,669) (213,086)
Other reserves 90,398 60,207
Profits carried forward 1,430,014 1,275,962
Net income 241,458 385,966
Interim dividend 0 (109,329)
Shareholders' equity attributable to equity holders of the
Parent 1,610,472 1,381,625
Shareholders' equity attributable to non‐controlling interests 0 0
Total shareholders' equity 16 1,610,472 1,381,625
Non‐current liabilities
Loans ‐ due after one year 17 1,404,176 760,473
Provisions for employee benefits 18 21,390 21,010
Deferred tax liabilities 19 163,776 26,675
Total non‐current liabilities 1,589,342 808,158
Current liabilities
Trade payables 20 219,638 177,925
Other payables 20 166,787 145,170
Tax liabilities 20 50,344 29,543
Other current liabilities 20 6,602 6,508
Provisions for risks and charges 20 16,939 21,396
Derivative instruments measured at fair value 21 21,578 14,156
Loans ‐ due within one year 17 290,496 223,061
Short‐term debts to banks and other lenders 22 5,656 8,657
Total current liabilities 778,040 626,416
Total shareholders' equity and liabilities 3,977,854 2,816,199

STATEMENT OF CONSOLIDATED COMPREHENSIVE INCOME

months
2021
2022
Net income
241,458
296,386
4,167
1,075
Gains/(losses) on cash flow hedges, net of tax effects
Gains/(losses) on translation of foreign financial statements
98,417
12,134
Gains/(losses) on equity‐accounted investees, net of tax effects
(6,900)
(3,353)
Other changes, net of tax effects
(367)
(57)
Income and expenses recognized in shareholders' equity
95,317
9,799
Comprehensive income
336,775
306,185
Attributable to:
Equity holders of the Parent
336,775
306,185
Non‐controlling interests
0
0
Per‐share value (euro)
Basic
1.638
1.487
Diluted
1.610
1.464
€ (thousands)(1) First nine First nine months

(1) Except amounts per share.

Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,637,085 in 2022 and 205,919,516 in 2021. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,488,071 shares in 2022 and 3,205,640 shares in 2021.

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

RECORDATI S.p.A. and SUBSIDIARIES

CONSOLIDATED STATEMENT OF CHANGE IN SHAREHOLDERS' EQUITY

Shareholders' equity attributable to equity holders of the Parent
€ (thousands) Share
capital
Share
premiu
m
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
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
Balance at 31 December
2021
26,141 83,719 (126,981) (974) (213,086) 60,207 1,275,962 385,966 (109,329) 0 1,381,625
Allocation of 2021 net
income
385,966 (385,966)
Dividend distribution (226,538) 109,329 (117,209)
Change in share‐based
payments
5,098 938 6,036
Purchase of treasury shares (39,138) (39,138)
Sale of treasury shares 16,337 (7,188) 9,149
Other changes 32,360 874 33,234
Comprehensive income 4,167 98,417 (7,267) 241,458 0 336,775
Balance at 30 September
2022
26,141 83,719 (149,782) 3,193 (114,669) 90,398 1,430,014 241,458 0 0 1,610,472

CONSOLIDATED CASH FLOW STATEMENT

€ (thousands) First nine First nine
months 2022 months 2021
OPERATING ACTIVITIES
Net income 241,458 296,386
Income taxes 68,260 54,350
Net interest 19,583 13,326
Depreciation of property, plant and equipment 19,675 18,928
Amortization of intangible assets 70,563 53,968
Write‐downs 2,175 0
Equity‐settled share‐based payment transactions 6,036 3,621
Other non‐monetary components 49,242 2,211
Change in other assets and other liabilities (5,759) (14,632)
Cash flow generated/(used) by operating activities
before change in working capital 471,233 428,158
Change in:
-
inventories
(30,379) 7,837
-
trade receivables
(30,925) (29,721)
-
trade payables
21,114 34,730
Change in working capital (40,190) 12,846
Interest received 1,026 214
Interest paid (14,385) (11,476)
Income taxes paid (55,992) (61,599)
Cash flow generated/(used) by operating activities 361,692 368,143
INVESTMENT ACTIVITIES
Investments in property, plant and equipment (15,987) (15,344)
Disposals of property, plant and equipment 547 158
Investments in intangible assets (67,697) (61,400)
Disposals of intangible assets 511 0
Acquisition of holdings in subsidiaries (653,759) * (304)
Cash flow generated/(used) by investment activities (736,385) (76,890)
FINANCING ACTIVITIES
Opening of loans 1,357,032 219,065
Repayment of loans (738,467) (216,381)
Payment of lease liabilities (7,355) (7,203)
Change in short‐term debts to banks and other lenders (8,768) (762)
Dividends paid (120,017) (109,389)
Purchase of treasury shares (39,138) (66,891)
Sale of treasury shares 9,149 37,863
Cash flow generated/(used) by financing activities 452,436 (143,698)
Change in cash and cash equivalents 77,743 147,555
Opening cash and cash equivalents 244,578 188,230
Currency translation effect 24,288 5,662
Effect of merger 479
Closing cash and cash equivalents 346,609 341,926
*Acquisition of EUSA Pharma (UK) Limited (653,759): working capital (182,384), fixed assets (534,756), goodwill (150,850), other assets

and liabilities 132,621, loans 81,610.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2022

1. GENERAL INFORMATION

The Interim Report for the Recordati Group for the period ended 30 September 2022 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, and was approved by the Board of Directors' on 8 November 2022, which authorized distribution to the public.

The Interim Financial Statements at 30 September 2022 include the economic‐equity position of the Parent Company and all its subsidiaries.

The scope of consolidation changed in the first quarter of 2022 following the Parent Company's acquisition of EUSA Pharma (UK) Limited ("EUSA Pharma") with its eleven subsidiaries. EUSA Pharma is a leading pharmaceutical company with a portfolio of four products in the niche rare cancer segment, with revenue of over € 150 million in 2021. The acquisition was completed on 16 March 2022, and the income statement was consolidated effective from 1 April 2022, whereas the balance sheet data was consolidated for the first time on 31 March. The accounting for the acquisition is still provisional, as permitted by the accounting standard IFRS 3, considering the short period of time that has passed since it was completed. For more details, see Note 23. The new company Recordati Rare Diseases FZCO was also established in the Middle East during the period.

The companies included in the scope of consolidation, their percentage of ownership and a description of their activity are set out in Note 28.

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

With reference to the direct economic and financial consequences of the ongoing conflict between Russia and Ukraine, it should be noted that the Group operates on the Russian market, in compliance with current regulations, with revenue in the first nine months of 2022 amounting to 5.3% of the Group's total revenue, and on the Ukrainian market, with revenue in the first nine months of 2022 of 0.6% of total revenue. The Group constantly monitors the evolution of the conflict, as well as any geopolitical developments and related consequences on corporate strategies. During the period, and also in light of the strong sales performance in Russia described in Note 9, there were no events or circumstances constituting possible impairment indicators with reference to goodwill (as already evident from the assessments made for the purposes of the consolidated condensed interim financial statements).

In the preparation of these quarterly financial statements, other impacts of the conflict were also considered which, although not significant, are mainly attributable to the recoverability of receivables.

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 2021, 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 impact, albeit potential, deriving from the Russia‐Ukraine crisis and 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 is derived from contracts with customers and is not subject to significant seasonal fluctuations.

In the first nine months of 2022, net revenue amounted to € 1,377.5 million (€ 1,156.2 million in the same period in 2021) and can be broken down as follows:

€ (thousands) First nine months First nine months Changes
2022 2021 2022/2021
Net sales 1,366,904 1,117,605 249,299
Royalties 5,564 4,045 1,519
Upfront payments 1,584 4,050 (2,466)
Various revenue 3,490 30,489 (26,999)
Total net revenue 1,377,542 1,156,189 221,353

The effect of applying IAS 29 "Financial Reporting in Hyperinflationary Economies" to activities in Turkey determined a positive effect on sales revenue of € 5.4 million.

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. Upfront payment revenue for € 1.6 million recognized in the first nine months of 2022 refers mainly to the marketing

agreements for lercanidipine (€ 0.5 million) and Cystadrops® (cysteamine hydrochloride) (€ 0.6 million). The remaining balance of amounts already paid in advance by customers, which will be recognized for accounting purposes as revenue in future periods, is recognized under current liabilities (see Note 20), and amounted to € 4.3 million (€ 5.9 million at 31 December 2021).

In the first nine months of 2021, "Various revenue" included € 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 January 2021 contract between Tolmar International Ltd. and Recordati S.p.A. for the assignment of the new product license. Following the change in the sales approach under which sales are made directly by Group companies, revenue from Eligard® in 2022 was entirely recognized in the item "Net sales".

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

€ (thousands) Specialty and
Primary Care
Specialty and
Primary Care
Rare
diseases
Rare
diseases
Total Total
2022 2021 2022 2021 2022 2021
Zanidip® 103,410 107,193 103,410 107,193
Zanipress® 28,526 31,307 28,526 31,307
Urorec® 46,183 45,265 46,183 45,265
Livazo® 35,708 31,849 35,708 31,849
Seloken®/Logimax® 72,512 72,991 72,512 72,991
Eligard® 78,640 59,362 78,640 59,362
Other corporate
products 136,352 118,713 136,352 118,713
OTC 227,685 200,133 227,685 200,133
Local product
portfolios 177,805 166,146 177,805 166,146
Drugs for rare diseases 429,791 279,386 429,791 279,386
Other revenue 5,054 8,413 5,054 8,413
Pharmaceutical
chemicals 35,876 35,431 35,876 35,431
Total net revenue 947,751 876,803 429,791 279,386 1,377,542 1,156,189

Product or product class

Geographic area by country

€ (thousands) Specialty and
Primary Care
Specialty and
Primary Care
Rare
diseases
Rare
diseases
Total Total
2022 2021 2022 2021 2022 2021
Net pharmaceutical revenue
Italy 188,909 181,196 17,928 14,621 206,837 195,817
France 99,559 87,609 26,594 24,595 126,153 112,204
Russia, Ukraine, other CIS 81,892 59,752 6,805 3,695 88,697 63,447
Germany 97,116 96,708 26,821 15,019 123,937 111,727
Spain 87,646 75,807 16,899 10,048 104,545 85,855
Turkey 53,197 49,224 6,748 4,284 59,945 53,508
Portugal 38,236 32,050 2,418 1,430 40,654 33,480
Other Eastern European
countries 79,662 73,511 15,143 6,770 94,805 80,281
Other Western European
countries 62,285 54,627 37,511 21,244 99,796 75,871
North Africa 26,021 25,902 2,636 1,431 28,657 27,333
Other international sales 97,352 104,986 79,540 48,740 176,892 153,726
U.S.A. 190,748 127,509 190,748 127,509
Total net pharmaceutical
revenue 911,875 841,372 429,791 279,386 1,341,666 1,120,758
Net pharmaceutical chemicals
revenue
Italy 1,847 4,031 1,847 4,031
Other European countries 10,761 13,119 10,761 13,119
U.S.A. 5,802 4,031 5,802 4,031
America (U.S.A. excluded) 3,911 3,104 3,911 3,104
Australasia 11,501 9,732 11,501 9,732
Africa 2,054 1,414 2,054 1,414
Total net pharmaceutical
chemicals revenue 35,876 35,431 0 0 35,876 35,431
Total net revenue 947,751 876,803 429,791 279,386 1,377,542 1,156,189

4. OPERATING EXPENSES

Total operating expenses for the first nine months of 2022 amounted to € 1,021.7 million, up compared to the € 783.3 million for the corresponding period the previous year, also as a result of consolidation of the EUSA Pharma activities starting from the second quarter, and are classified by function as follows:

€ (thousands) First nine
months 2022
First nine months
2021
Changes
2022/2021
Cost of sales 422,804 313,005 109,799
Selling expenses 331,226 287,007 44,219
Research and development expenses 155,700 119,691 36,009
General and administrative expenses 80,542 60,057 20,485
Other (income)/expenses, net 31,389 3,502 27,887
Total operating expenses 1,021,661 783,262 238,399

The cost of sales was € 422.8 million, up compared to the first nine months of 2021. The ratio to revenue was 30.7%, higher than the 27.1% of the first nine months of 2021. The higher ratio was due mainly to the revaluation of the EUSA Pharma inventories acquired according to the provisions of the accounting standard

IFRS 3, the negative effect of which on the income statement calculated on the basis of the units sold in the period amounted to € 35.6 million, the effect of € 11.8 million for the application of IAS 29 "Financial Reporting in Hyperinflationary Economies" to activities in Turkey, and the effect of € 9.9 million for the change in the sales approach for Eligard®, which is now sold directly by Group companies.

Selling expenses increased by 15.4% due to the resumption in promotional activities compared to the same period of the previous year (which was still affected by the COVID‐19 pandemic), to the consolidation of the EUSA Pharma activities and to the increased resources needed to support the growth of endocrinology products. This increase was nonetheless partially offset by the benefits of the efficiency measures put in place at the end of 2021 with regard to the organization of the Specialty and Primary Care sector sales force, primarily in Germany and Turkey. Expenses as a percentage of revenue came down compared to the same period of the previous year due to a particularly positive revenue performance.

Research and development expenses were € 155.7 million, an increase of 30.1% compared to those of the first nine months of the previous year owing both to the integration of the EUSA Pharma expenses (including € 12.3 million of amortization of intangible fixed assets) and to the increase in investments in support of products for endocrinology.

General and administrative expenses increased by 34.1% owing to the integration of EUSA Pharma and the strengthening of the general coordination structure to support an increasingly complex portfolio resulting from recent acquisitions.

€ (thousands) First nine
months 2022
First nine
months 2021
Changes
2022/2021
Non‐recurring costs:
‐ EUSA Pharma acquisition 19,249 19,249
‐ restructuring 11,142 11,142
‐ Ukraine emergency 1,230 1,230
‐ COVID‐19 epidemic 597 1,822 (1,225)
Other (829) 1,680 (2,509)
Other (income)/expenses, net 31,389 3,502 27,887

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

The costs associated with the acquisition of EUSA Pharma mainly relate to Tech Transfer fees, a specific insurance policy to cover potential risks from limitations of warranties provided by previous shareholders and management of the company during the due diligence process, and the registry tax paid on the acquisition. Restructuring costs referred to "severances" relating to "right sizing" the sales area in the Specialty and Primary Care segment and other organizational changes.

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

The table below shows the analysis of the costs by nature, which reflects also the increases deriving from consolidation of the EUSA Pharma activities starting from the second quarter:

€ (thousands) First nine months
2022
First nine months
2021
Changes
2022/2021
Material consumption 304,434 238,038 66,396
Payroll costs 235,499 201,494 34,005
Other employee costs 34,339 21,624 12,715
Variable sales expenses 88,320 80,488 7,832
Depreciation and amortization 90,238 72,896 17,342
Utilities and consumables 30,633 27,181 3,452
Other expenses 238,198 141,541 96,657
Total operating expenses 1,021,661 783,262 238,399

The proportion of raw material consumption to net revenue was 22.1%, up by 1.5% compared to the same period in 2021. This increase was mainly determined by the effect of hyperinflation in Turkey of approximately € 11 million and by the different sales method adopted for Eligard®. While in 2022, revenue was almost all derived from direct sales made by Recordati, in the first half of 2021, it was mainly made up of the transfer to Recordati of gross profit made by the previous licensee Astellas.

The item "Payroll costs" increased as a result of the integration of the EUSA Pharma personnel and the increases awarded in the early months of the year, and includes stock option plan expenses of € 6.0 million in the first nine months of 2022 and € 3.6 million in the same period of the previous year.

Starting in 2019, some Group employees were designated as beneficiaries of an incentive plan with a 5‐year vesting period, granted and entirely funded by 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 if they have met a number of performance conditions. The measurement according to the accounting standard IFRS 2 led to an expense in the first nine months 2022 income statement of € 1.0 million, which also includes the incentive plan granted by Rossini Luxembourg S.à r.l. to the Chief Executive Officer of the Recordati Group.

The amortization items classified above amounted to € 90.2 million, of which € 70.5 million related to intangible assets, up by € 16.6 million over the same period of the previous year owing mostly to the acquisition of EUSA Pharma, and € 19.7 million relating to property, plant and equipment, up by € 0.7 million over the first half of 2021.

The change in "Other expenses" is mainly attributable to higher non‐recurring items and to the non‐cash charges of € 35.6 million arising from the release of the purchase price allocation of EUSA Pharma to the gross margin of acquired inventories pursuant to IFRS 3.

5. NET FINANCIAL INCOME AND EXPENSES

In the first nine months of 2022 and same period in 2021, the balance of financing items was negative for € 46.2 million and € 22.2 million, respectively. The main balance items are summarized in the table below.

€ (thousands) First nine
months
2022
First nine months
2021
Changes
2022/2021
Interest expense on loans 19,718 12,605 7,113
Net exchange rate (gains)/losses 18,231 6,753 11,478
Hyperinflation effects (IAS 29) 5,590 5,590
Net (income)/expense on short‐term positions 1,982 2,211 (229)
Expenses on leases 560 591 (31)
Expenses for defined benefit plans 82 31 51
Total net financial (income)/expenses 46,163 22,191 23,972

The increase in interest expense on loans was mainly due to the opening of new debt by the Parent Company to make the investment in EUSA Pharma. During the first quarter two distinct loans had been taken out for an overall total of € 650.0 million: loan of € 200.0 million with a term of 5 years and a "Bridge Facility" of € 450.0 million with a maximum term of 12 months, extendible at the Company's discretion for a further 6 months, to enable in the meantime to enter into definitive loan instruments. On 28 June 2022 the loan of € 200.0 million was modified increasing the total debt to € 800.0 million with the involvement of other credit institutions and the "Bridge Facility" loan was repaid entirely. The treatment of the operations according to the accounting standard IFRS 9 determined a total expense accruing to the first nine months of 2022 of € 8.5 million.

Note number 17 contains the details of the loan contracts.

Net exchange losses, mostly unrealised, were mainly determined by the significant revaluation of the Russian rouble and the US dollar against the euro, in particular starting from the end of the second quarter of 2022.

6. INCOME TAXES

Income taxes amounted to € 68.3 million and include income taxes levied on all consolidated companies as well as the Italian regional tax on production (IRAP) which is levied on all Italian companies.

In 2019, the Parent Company signed an advance agreement with the Italian Tax Authority to define the calculation methods and criteria for a discount on taxable income connected with the direct use of intangible assets for the 2015 to 2019 tax years. For the 2020 tax year, however, Recordati S.p.A. has subscribed to the reverse charge mechanism with reference to those assets from the previous five years (with the exception of expired patents and the brands excluded in the meantime from the objective scope of the subsidy), exercising, in the tax return for that year, the option until the expiry of the five years of validity of the option (2020‐2024). Subsequently, on 21 October 2021, the Company filed a request for the purposes of activating the advance agreement procedure connected to the use of the intangible assets for the remaining 2021‐2024 period, indicating the same calculation methods and criteria for the discount used in the previous periods. The Company, operating in line with the previous years, determined the tax benefit pertaining to the first nine months of 2022, recognized to reduce the tax amounts, as € 5.7 million.

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 2021 92,394 243,540 99,736 27,155 462,825
Additions 2,428 1,539 4,050 12,387 20,404
Disposals (1,780) (1,291) (4,271) (107) (7,449)
Change to scope of consolidation 2,718 0 2,202 0 4,920
Hyperinflation Turkey 9,866 12,290 2,077 25 24,258
Other changes (122) 330 1,487 (1,972) (277)
Balance at 30 September 2022 105,504 256,408 105,281 37,488 504,681
Accumulated amortization
Balance at 31 December 2021 55,702 203,515 72,488 0 331,705
Amortization for the period 5,157 6,726 7,792 0 19,675
Disposals (1,795) (836) (4,101) 0 (6,732)
Change to scope of consolidation 100 0 1,005 0 1,105
Hyperinflation Turkey 604 9,751 968 0 11,323
Other changes 248 (310) 441 0 379
Balance at 30 September 2022 60,016 218,846 78,593 0 357,455
Net amount
31 December 2021 36,692 40,025 27,248 27,155 131,120
30 September 2022 45,488 37,562 26,688 37,488 147,226

Increases over the period amounted to € 20.4 million and mainly refer to the Parent Company (€ 12.2 million).

"Other changes" includes the conversion into euro of the property, plant and equipment recognized in different currencies, for a net decrease of € 0.7 million compared to 31 December 2021, mainly owing to the double effect of the devaluation of the Turkish lira (€ 1.3 million) and the revaluation of the Russian rouble (€ 0.3 million) and the Swiss franc (€ 0.2 million).

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 2021 20,688 1,433 19,085 41,206
Additions 2,264 0 2,071 4,335
Disposals (1,780) 0 (3,431) (5,211)
Change to scope of consolidation 2,524 0 847 3,371
Other changes 261 0 93 354
Balance at 30 September 2022 23,957 1,433 18,665 44,055
Accumulated amortization
Balance at 31 December 2021 8,816 417 9,189 18,422
Amortization for the period 3,290 214 4,108 7,612
Disposals (1,795) 0 (3,359) (5,154)
Change to scope of consolidation 0 0 0 0
Other changes 173 0 (14) 159
Balance at 30 September 2022 10,484 631 9,924 21,039
Net amount
31 December 2021 11,872 1,016 9,896 22,784
30 September 2022 13,473 802 8,741 23,016

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 2021 1,067,019 561,269 20,478 54,749 1,703,515
Additions 1,745 42,908 220 10,790 55,663
Disposals 0 (605) (67) (368) (1,040)
Change to scope of consolidation 0 528,328 566 4,568 533,462
Write‐downs 0 (2,175) 0 0 (2,175)
Hyperinflation Turkey 0 5,458 1,362 13 6,833
Other changes 74,167 9,354 35 (4,921) 78,635
Balance at 30 September 2022 1,142,931 1,144,537 22,594 64,831 2,374,893
Accumulated amortization
Balance at 31 December 2021 305,705 240,789 18,235 0 564,729
Amortization for the period 36,968 33,112 483 0 70,563
Disposals 0 (605) (67) 0 (672)
Change to scope of consolidation 0 2,088 433 0 2,521
Hyperinflation Turkey 0 3,629 1,060 0 4,689
Other changes 17,096 1,454 2 0 18,552
Balance at 30 September 2022 359,769 280,467 20,146 0 660,382
Net amount
31 December 2021 761,314 320,480 2,243 54,749 1,138,786
30 September 2022 783,162 864,070 2,448 64,831 1,714,511

Increases for the period include:

  • € 35.0 million for the milestone included in the license agreement with Tolmar International Ltd relating to the marketing of Eligard® (leuprorelin acetate), a medicinal product for the treatment of prostate cancer, in Europe, Turkey, Russia and other countries;
  • € 5.0 million for the milestone included in the license agreement with Helsinn Healthcare relating to the marketing of Ledaga®;
  • € 9.4 million referring to clinical studies that comply with the criteria set by the IAS 38 accounting standard on capitalisation;
  • € 2.9 million for investments in software.

Intangible assets deriving from the acquisition of EUSA Pharma were recognized in "Change to scope of consolidation", for a total net amount of € 530.9 million, mainly relating to Qarziba®, Sylvant®, Fotivda® and Caphosol® following the purchase price allocation under IFRS 3. On the basis of the knowledge of the market in which the company acquired operates and considering the trend in sales of specialties, a useful life of 20 years was estimated for these assets. The purchase price allocation for the acquisition of EUSA Pharma is preliminary and can be changed under certain circumstances, as permitted under the relevant accounting standard.

"Other changes" includes the conversion into euro of the value of the intangible assets held and recognized in different currencies, which determined a net increase of € 60.2 million compared to 31 December 2021, mainly attributable to the revaluation of the Swiss franc for € 44.5 million, of the Russian rouble for € 5.5 million and of the U.S. dollar for € 10.2 million.

9. GOODWILL

Goodwill at 30 September 2022 and 31 December 2021 amounted to € 707.7 million and € 553.2 million respectively and changed as follows:

€ (thousands)
Balance at 31 December 2021 553,209
Change to scope of consolidation for EUSA Pharma 150,850
Exchange rate adjustments 3,650
Balance at 30 September 2022 707,709

As required by the accounting standard IFRS 3 and noted in Note 23, a preliminary purchase price allocation for the acquisition of EUSA Pharma and its subsidiaries was made.

As part of the PPA, which is provisional at this time, goodwill amounting to € 150.9 million was recognized and allocated to the treatment of rare diseases segment.

Considering the short period of time that has passed between the acquisition date and 30 September 2022, the allocation made should be considered still provisional, as permitted by the accounting standard IFRS 3.

The exchange rate adjustments are related to the goodwill associated with the acquisitions made in companies with currencies other than the euro. Goodwill calculated in local currency is translated into euro for the preparation of the consolidated financial statements using the year‐end exchange rates. Compared to 31 December 2021, this determined a total net increase of € 3.6 million attributable to the acquisitions made in Russia (increase of € 5.6 million), Switzerland (increase of € 0.7 million), Tunisia (increase of € 0.4 million), the Czech Republic (increase of € 0.2 million), Poland (decrease of € 0.7 million) and Turkey (decrease of € 2.6 million).

Net goodwill at 30 September 2022, amounting to € 707.7 million, is divided among the following operational areas, which represent the same number of cash‐generating units:

  • France for € 74.2 million;
  • Russia for € 30.5 million;
  • Germany for € 48.8 million;
  • Portugal for € 32.8 million;
  • Business dedicated to medication for the treatment of rare diseases: € 261.4 million;
  • Turkey for € 13.8 million;
  • Czech Republic for € 14.4 million;
  • Romania for € 0.2 million;
  • Poland for € 13.5 million;
  • Spain for € 58.1 million;
  • Tunisia for € 17.1 million:
  • Italy for € 133.2 million;
  • Switzerland for € 9.7 million.

In compliance with IFRS 3 goodwill is not systematically amortized. Instead, it is tested for impairment on an annual basis or more frequently if specific events or circumstances indicate a possible loss of value. During the period, and also in light of the strong sales performance and the absence of problems related to collections from customers and intra‐group payments for the supply of products in Russia, there were no events or circumstances constituting possible impairment indicators with reference to the above‐mentioned goodwill (as already evident from the assessments made for the purposes of the consolidated condensed interim financial statements).

It should be noted that EUSA Pharma, which was consolidated into the treatment of rare diseases CGU, performed above expectations in the first nine months of 2022.

10. OTHER EQUITY INVESTMENTS AND SECURITIES

At 30 September 2022, these amounted to € 27.0 million, down by € 7.2 million compared to 31 December 2021.

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 2022, the total fair value of the 9,554,140 shares held was € 26.7 million. The value of the investment was consequently adjusted to the stock exchange value and fell by € 6.5 million, compared to 31 December 2021, 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 € 0.2 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 € 0.7 million, compared to 31 December 2021, 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

As at 30 September 2022, this item came to € 55.5 million, up by € 22.6 million compared to 31 December 2021, and refers mainly to the fees paid as an advance to Novartis Pharma for the transfer of the assets used for microparticle production of Signifor® LAR. It should be noted that, as provided for in the agreement signed on 30 September 2022 following the regulatory approval by the competent Swiss authority, the transfer of control of the assets and the associated risks to Recordati AG is effective from 1 October 2022. The effect of the EUSA Pharma consolidation was € 1.0 million.

12. DEFERRED TAX ASSETS

At 30 September 2022, deferred tax assets amounted to € 83.4 million, recording a net increase of € 7.4 million compared to 31 December 2021. The balance related to EUSA Pharma was € 3.6 million.

13. CURRENT ASSETS

Inventories amounted to € 404.0 million, up by € 175.2 million compared to 31 December 2021. The change is mainly due to the consolidation of EUSA Pharma. As highlighted in Note 23, the value identified on the acquisition date was € 162.7 million, of which € 141.9 referred to the fair value assessment of the acquired assets conducted for the preliminary purchase price allocation. The application of IAS 29 in Turkey determined an increase of € 7.0 million.

Trade receivables amounted to € 393.4 million at 30 September 2022, up by € 85.7 million compared to 31 December 2021. The balance is shown less the provision for doubtful accounts for € 18.2 million, up by € 4.2

million over 31 December 2021, recognized in selling expenses, which reflects the collection risk connected with certain customers and geographic areas. The net effect of EUSA Pharma as of 30 September 2022 was € 48.7 million. Average days sales outstanding are 71.

Other receivables amounted to € 49.6 million, up by € 4.7 million compared to 31 December 2021, mainly due to the figures of EUSA Pharma, at € 9.9 million.

Other current assets amounted to € 17.5 million, of which € 4.5 million related to EUSA Pharma, and refer mainly to prepaid expenses.

No particular impact on the recoverability of receivables is reported in the geographical areas affected by the Russia‐Ukraine conflict.

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

At 30 September 2022, the value of derivative instruments included under this item amounted to € 31.4 million.

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 € 16.8 million asset at 30 September 2022. 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 50 million US dollars tranche of the loan, with a residual debt of 40 million US dollars at 30 September 2022, provided by Mediobanca, was positive for € 10.5 million, and that hedging the 25 million US dollar tranche of the loan, provided by UniCredit, yielded a € 6.3 million positive change.

The measurement at market (fair) value of the interest rate swaps hedging a number of loans gave rise to total assets of € 5.6 million, representing the opportunity of paying in the future, for the term of the loans, the agreed interest rates rather than the variable rates currently expected. The measurement relates to the interest rate swaps entered into by the Parent Company to hedge the interest rates on the syndicated loan finalized in the first half of the year (€ 5.0 million) and the loan with Mediobanca (€ 0.6 million).

At 30 September 2022, other hedging transactions were in place on foreign currency positions, the measurement of which was positive for € 9.0 million against € 0.1 million at 31 December 2021, with the difference 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 2022, the balance of this item amounted to € 346.6 million, increasing by € 102.0 million on 31 December 2021, and are mainly denominated in euro, US dollars, pounds sterling and comprise current account deposits and short‐term time deposits. The amount of cash and cash equivalents of EUSA Pharma at the acquisition date amounted to € 53.2 million.

16. SHAREHOLDERS' EQUITY

Shareholders' Equity at 30 September 2022 was € 1,610.5 million, an increase of € 228.8 million compared to 31 December 2021 due to the effect of the following reasons:

  • increase of € 241.5 million from net income;
  • increase of € 6.0 million from cost of stock option plans set‐off directly in equity;
  • decrease of € 39.1 million from the purchase of 852,898 treasury shares;
  • increase of € 9.1 million from the disposal of 400,750 treasury shares to service the stock option plans;
  • increase of € 4.2 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 € 7.2 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 € 98.4 million for foreign currency translation adjustments;
  • increase of € 33.1 million from other changes, of which € 32.4 million attributable to the effects of application of IAS 29 in Turkey;
  • decrease of € 117.2 million from the distribution of the dividend balance.

At 30 September 2022, the Company has three stock option plans benefiting certain Group employees: the 2014‐2018 plan with the grants of 29 July 2014 and 13 April 2016, the 2018‐2022 plan, with the grant of 3 August 2018, and the 2021‐2023 plan with the grants of 6 May 2021, 1 December 2021 and 24 February 2022. 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 and 2022 grants, 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.

Stock options outstanding at 30 September 2022 are detailed in the following table:

Strike price
(€)
Quantity
1/1/2022
Granted
2022
Exercised in
2022
Cancelled and
expired
Quantity
30/9/2022
Grant date
29 July 2014 12.29 476,500 (159,500) 317,000
13 April 2016 21.93 934,000 (25,500) 908,500
3 August 2018 30.73 2,896,000 (215,750) (21,250) 2,659,000
6 May 2021 45.97 2,925,500 (211,000) 2,714,500
1 December 2021 56.01 130,000 130,000
24 February 2022 47.52 3,553,000 3,553,000
Total 7,362,000 3,553,000 (400,750) (232,250) 10,282,000

At 30 September 2022, 3,666,448 treasury shares were held in the portfolio, an increase of 452,148 shares compared to 31 December 2021. The change was due to the disposal of 400,750 shares for an amount of € 9.1 million to enable the options attributed to employees as part of the stock option plans to be exercised and to the purchase of 852,898 shares for an amount of € 39.1 million. The total cost to purchase the treasury shares in the portfolio was € 149.8 million, with an average unit price of € 40.85.

Starting in 2019, some Group employees were designated as beneficiaries of an incentive plan with a 5‐year vesting period, granted and entirely funded by 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 if they have met a number of performance conditions. The measurement according to the accounting standard IFRS 2 led to an expense in the 2022 income statement of € 1.0 million, which also includes the incentive plan granted by Rossini Luxembourg S.à r.l. to the Chief Executive Officer of the Recordati Group.

17. LOANS

At 30 September 2022, loans amounted to € 1,694.7 million, increasing by a net € 711.1 million compared to 31 December 2021.

This item includes the liabilities deriving from the application of the accounting standard IFRS 16, representing the obligation to make the payments provided for in the existing leases for a total amount of € 23.5 million, a net decrease of € 0.3 million compared to 31 December 2021.

During the first nine months of 2022, loans increased by € 1,443.0 million: € 1,357.1 million for the opening of new bank loans, € 78.2 million included among the acquired liabilities of EUSA Pharma and € 7.7 million related to new leases, of which € 3.4 million deriving from the first consolidation of the new companies acquired. Repayments for a total of € 749.4 million were made in the period, of which € 663.8 million for the repayment of bank loans, € 78.2 million for total repayment of the debt undertaken to acquire EUSA Pharma and € 7.4 million relating to lease liabilities. The values of bank loans reflect the opening and subsequent "take out" with definitive financing of the "Bridge Facility" relating to the acquisition of EUSA Pharma, as illustrated below.

During the period, some loans reached maturity and were extinguished. Specifically:

  • in August, the loan of 71.6 million Turkish lira, disbursed on 16 October 2014 to the subsidiary Recordati Ilaç by IFC‐World Bank, ended with the payment of the final instalment;
  • the 2017 loan with UBI Banca (now Intesa Sanpaolo) ended in September with the single instalment repayment of € 50.0 million;

With the aim of improving the management of its overall debt, the Parent Company ended two loans in advance of their natural maturity. Specifically:

  • the loan from Intesa Sanpaolo, expiring in October 2025, ended in August with the repayment of the outstanding debt of € 37.5 million;
  • the loan from Mediobanca, maturing in July 2024, was extinguished in September with the repayment of the residual debt of € 22.5 million;

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 € 17.5 million compared to 31 December 2021.

The main loans outstanding are:

a) On 12 September 2022, the Parent Company issued a bond for € 75.0 million, privately placed and entirely among companies belonging to the Prudential Group. The main terms provide for a fixed rate with interest payments every six months and a term of 12 years, with repayment of the principal in five annual instalments starting in September 2030 and expiring on 12 September 2034. The transaction, aimed at continuing to raise medium‐ to long‐term funds to further support the Group's growth, has facilitated access to favourable market conditions. It has standard market characteristics typical of the US private placement market and is substantially in line with the bond issued by the Parent Company in 2017. 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 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 a total of € 800,0 million negotiated by Recordati S.p.A. in two different stages.

On 3 February 2022 the Parent Company signed a loan contract for € 200.0 million for the purpose of acquiring EUSA Pharma (UK) Limited, disbursed by a consortium of national and international lenders made up of Mediobanca, JP Morgan, UniCredit and Banca Nazionale del Lavoro. 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 5‐year term with semi‐annual repayment of the principal starting 31 March 2023, with the final instalment on 3 February 2027. Disbursement, net of structuring and up‐front fees, took place on 15 March 2022.

Again on 3 February 2022 the Parent Company agreed a "Bridge Facility" for a total of € 450.0 million again for the purpose of financing the acquisition of EUSA Pharma (UK) Limited. The financial institutions are Mediobanca, which also serves as the agent, and JP Morgan with a portion of € 157.5 million, UniCredit for € 67.5 million, Banca Nazionale del Lavoro for € 54.0 million, and BNP Paribas for € 13.5 million. The maximum term of the loan is 12 months and may be extended, at the Company's discretion, for 6 more months to allow for final financial instruments to be negotiated in the meantime. The terms include a variable interest rate at the Euribor rate at the time of use (with floor to zero) plus a variable spread. The disbursement, net of fees, took place on 15 March 2022.

In the second quarter, Recordati S.p.A. finalized the negotiation of a syndicated loan for the repayment of the bridge loan. The interest shown by both partner banks and by new international credit institutions was significant. It was therefore possible to proceed to the collection of an additional € 150.0 million. This operation was formalised on 28 June 2022 through the signing of an "amendment and restatement" of the € 200.0 million loan negotiated in February 2022. The amendment in question made it possible to

increase the value of the loan to € 600.0 million, of which € 450.0 million deriving from replacement of the "Bridge" plus an additional € 150 million.

The main economic terms of the loan remained substantially in line with the original ones, with 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 5‐year term with semi‐annual repayment of the principal starting 31 March 2023, with the final instalment on 3 February 2027. In July 2022, the loan was partially hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the hedged portion to a fixed interest rate. At 30 September 2022, the fair value of the derivatives was measured as a positive € 5.0 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 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 40.0 million Swiss francs taken out on 16 March 2022 by the subsidiary Recordati AG with UBS Switzerland AG, at a fixed interest rate, with quarterly interest payments and semi‐annual repayment of principal starting September 2022 through March 2025. The value in euro of the outstanding loan at 30 September 2022 was € 34.8 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) € 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 at the 6‐ month Euribor (with a zero floor) plus a fixed spread, and a 5‐year term with a 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.

e) Loan for € 40.0 million taken out by the Parent Company on 30 March 2021 with Allied Irish Bank with a variable interest rate at 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 semi‐annual interest payments and principal repayment, again on a semi‐annual basis, starting from March 2022 until March 2026. The debt outstanding recognized at 30 September 2022 amounted to a total of € 37.9 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.

f) 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 to March 2025. The value in euro of the outstanding loan at 30 September 2022 was € 39.2 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.

g) 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 5‐year term 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 2022 amounted to a total of € 248.0 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.
  • h) 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 5‐year term with semi‐annual repayments of principal starting November 2020 through to November 2023. The debt outstanding at 30 September 2022 amounted to € 64.1 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 2022, the fair value of the derivative was measured as a positive € 0.6 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 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 € 15.0 million taken out by the Parent Company in November 2017 with Banca Passadore. The main conditions provide for a variable interest rate at the 3‐month Euribor plus a fixed spread, quarterly payments of interest and a 5‐year term with annual repayments of principal from November 2020 through to November 2022. The debt outstanding at 30 September 2022 amounted to a total of € 5.0 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.

j) 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 bonded loan 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.
  • k) 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. During the period, 10 million US dollars of the first tranche was repaid, and the outstanding debt at 30 September 2022 amounted to a total of 65 million US dollars, equalling a counter‐value of € 66.7 million.

The loan was hedged at the same time with two cross‐currency swaps which provide for the conversion of the original debt into a total of € 56.0 million (€ 48.5 million at 30 September 2022), of which € 37.3 million (€ 29.8 at the date of this Annual Report) at a lower fixed rate for the tranche with maturity at 12 years and € 18.7 million again at a lower fixed rate for the one maturing at 15 years. At 30 September 2022, hedging instruments measured at fair value were positive for a total of € 16.8 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 bonded loan 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 2022, 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 2022, deferred tax liabilities amounted to € 163.8 million, up by € 137.1 million compared to 31 December 2021, owing mainly to the consolidation of EUSA Pharma. At the first consolidation date, deferred tax liabilities, calculated as part of the preliminary purchase price allocation based on the provisions established by accounting standard IFRS 3, stood at € 141.5 million, as shown in Note 23.

20. CURRENT LIABILITIES

Trade payables, including the provisions at the end of the period for invoices to be received, amounted to € 219.6 million and included the balance related to EUSA Pharma of € 24.1 million.

Other liabilities amounted to € 166.8 million, increasing by € 21.6 million compared to 31 December 2021, and mainly include:

  • € 65.1 million due to employees and social security institutions;
  • € 18.8 million for Recordati AG in respect of Novartis AG, on the occurrence of contract conditions in the scope of acquiring the rights for Isturisa®;
  • € 15.3 million which Recordati Rare Diseases Inc. must pay to U.S. health care insurance schemes;
  • € 3.5 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;
  • € 2.7 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;
  • € 2.2 million to be paid to the Krankenkassen (German health insurance schemes) by Recordati Pharma GmbH;
  • € 16.4 million relative to EUSA Pharma.

Tax liabilities amounted to € 50.3 million, increasing by € 20.8 million compared to 31 December 2021. The balance related to EUSA Pharma amounted to € 6.8 million.

Other current liabilities amounted to € 6.6 million, substantially in line with December 2021. An amount of € 4.3 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 € 16.9 million, down by € 4.5 million compared to 31 December 2021.

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

At 30 September 2022, the value of derivative instruments included under this item amounted to € 21.6 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 2022 on the outstanding loan of 142.7 million Swiss francs was a negative for € 20.4 million compared to the € 9.3 million at 31 December 2021, with the difference recognized in the income statement, offsetting the exchange gains determined by the valuation of the underlying loan at current exchange rates.

At 30 September 2022, other hedging transactions were in place on foreign currency positions, the overall measurement of which was a negative € 1.2 million against € 2.8 million at 31 December 2021, with the difference recognized in the income statement 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 accounting standard IFRS 13 (see note 2). 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.

22. SHORT‐TERM DEBTS TO BANKS AND OTHER LENDERS

Short‐term debts to banks and other lenders at 30 September 2022 were € 5.7 million and comprise temporary use of short‐term credit lines, overdrafts of a number of foreign associates and interest due on existing loans.

On 1 March 2022, the Parent Company took out a revolving credit line with UniCredit, with a maximum term of 12 months and for a maximum amount of € 40 million. This credit line, which had not been used at 30 September 2022, is a short‐term financing instrument providing financial flexibility, combining irrevocability with variability of use based on specific financial requirements. The agreement signed requires compliance with financial and income conditions similar to those for other existing loans.

23. ACQUISITION OF SUBSIDIARIES

On 16 March 2022 the Group acquired 100% of the shares of EUSA Pharma, a leading pharmaceutical company with a portfolio of four products in the niche rare cancer segment, with its eleven subsidiaries. For accounting purposes, the acquisition was consolidated on 31 March 2022.

The fair value of the assets and liabilities of EUSA Pharma was determined on a provisional basis since, as of the date of publication of this report, the assessments are in the process of being finalised.

As permitted under IFRS 3, the fair value of assets, liabilities and contingent liabilities will be determined definitively within twelve months of the acquisition date.

The table below summarises the values of the assets acquired and the liabilities assumed, expressed at their fair value. These values differ from those published in the quarterly report at 31 March 2022, when, given the short period of time that had passed since the acquisition date, the necessary activities had not yet been undertaken for an in‐depth measurement of the values acquired.

€ (thousands) Values at
31 March 2022
(pursuant to IFRS 3)
Non‐current assets
Property, plant and equipment 3,815
Intangible assets 530,941
Other non‐current assets 961
Deferred tax assets 5,161
Current assets
Inventories 162,653
Trade receivables 37,158
Other receivables 7,554
Other current assets 7,300
Cash and cash equivalents 53,235
Non‐current liabilities
Loans ‐ due after one year (2,212)
Deferred tax liabilities (141,483)
Other non‐current liabilities 0
Current liabilities
Trade payables (17,426)
Other payables (11,501)
Tax liabilities (157)
Other current liabilities (182)
Provisions for risks and charges (275)
Loans ‐ due within one year (79,398)
556,144
Goodwill 150,850
Cost of the acquisition 706,994

The preliminary process of identifying the assets and liabilities acquired at the related fair values at the acquisition date led to the identification of a higher value of the intangible assets Qarziba®, Sylvant®, Fotivda® and Caphosol® and of the related inventories. Consequently, the difference between the cost of the business combination and the carrying amount of the assets and liabilities acquired was allocated for € 440.0 million to intangible assets, for € 141.9 million to inventories, for € 141.5 million to the related deferred tax liabilities and for € 150.9 million to the item "Goodwill". Considering the short period of time that has passed between the acquisition date and 30 September 2022, the allocation made should be considered still provisional, as permitted by the accounting standard IFRS 3.

The table below shows the acquisition cash flow breakdown:

Cash flow net of acquisition (653,759)
Amount paid (706,994)
Acquired cash and cash equivalents 53,235
€ (thousands)

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 2022 and include comparative data.

€ (thousands) Specialty and
Primary Care
segment
Rare diseases
segment
Values not
allocated
Consolidated
financial
statements
First nine months 2022
Net revenue 947,751 429,791 1,377,542
Expenses (683,199) (338,462) (1,021,661)
Operating income 264,552 91,329 355,881
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

€ (thousands) Specialty and Rare diseases Not allocated* Consolidated
Primary Care
segment
segment financial
statements
30 September 2022
Non‐current assets 1,200,378 1,507,952 26,972 2,735,302
Inventories 220,069 183,912 403,981
Trade receivables 250,255 143,182 393,437
Other receivables and other current
assets 37,995 29,109 31,421 98,525
Cash and cash equivalents 346,609 346,609
Total assets 1,708,697 1,864,155 405,002 3,977,854
Non‐current liabilities 43,184 141,982 1,404,176 1,589,342
Current liabilities 272,407 187,903 317,730 778,040
Total liabilities 315,591 329,885 1,721,906 2,367,382
Net capital employed 1,393,106 1,534,270
31 December 2021
Non‐current assets 1,162,131 769,843 34,124 1,966,098
Inventories 182,344 46,388 228,732
Trade receivables 228,591 79,187 307,778
Other receivables and other current 45,712 12,152 11,149 69,013
assets
Cash and cash equivalents 244,578 244,578
Total assets 1,618,778 907,570 289,851 2,816,199
Non‐current liabilities 41,440 6,245 760,473 808,158
Current liabilities 249,046 131,496 245,874 626,416
Total liabilities 290,486 137,741 1,006,347 1,434,574
Net capital employed 1,328,292 769,829

* 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—whose fulfillment is as yet uncertain—occur, with the consequence that the contractually required payments, estimated at around € 132 million, are merely potential at the moment.

26. RELATED‐PARTY TRANSACTIONS

At 30 September 2022, 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 VII Limited.

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.

28. SUBSIDIARIES INCLUDED IN THE CONSOLIDATED ACCOUNTS AT 30 SEPTEMBER 2022

Consolidated companies Head office Share capital Currency Consolidation
method
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA 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.
Development, promotion, and sales of pharmaceutical products
Turkey 8,000,000.00 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 90,000,000.00 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
RECORDATI RARE DISEASES FZCO(2)
Marketing of pharmaceuticals
United Arab
Emirates
1,000.00 AED Line‐by‐line
EUSA Pharma (UK) Limited(3)
Research and marketing of pharmaceuticals
United Kingdom 10.00 EUR Line‐by‐line
EUSA Pharma (Italy) S.r.l. (3)
Marketing of pharmaceuticals
Italy 99,000.00 EUR Line‐by‐line
EUSA Pharma (France) S.A.S. (3)
Marketing of pharmaceuticals
France 476,522.00 EUR Line‐by‐line
EUSA Pharma Iberia S.L. (3)
Marketing of pharmaceuticals
Spain 70,000.00 EUR Line‐by‐line

Consolidated companies Head office Share capital Currency Consolidation
method
EUSA Pharma (Germany) GmbH(3)
Marketing of pharmaceuticals
Germany 25,000.00 EUR Line‐by‐line
EUSA Pharma (Netherlands) B.V. (3)
Marketing of pharmaceuticals
Netherlands 1.00 EUR Line‐by‐line
EUSA Pharma (Denmark) ApS(3)
Marketing of pharmaceuticals
Denmark 50,000.00 DKK Line‐by‐line
EUSA Pharma (US) LLC(3)
Marketing of pharmaceuticals
U.S.A. 1.00 USD Line‐by‐line
EUSA Pharma (Australia) Pty Ltd(3)
Non‐operational
Australia 1.00 AUD Line‐by‐line
EUSA Pharma (CH) GmbH(3)
Marketing of pharmaceuticals
Switzerland 20,000.00 CHF Line‐by‐line
EUSA Pharma Korea Ltd(3)
Marketing of pharmaceuticals
South Korea 100,000,000.00 KRW Line‐by‐line
EUSA Pharma Brasil ‐ Marketing e Promoçoes LTDA(3)
Non‐operational
Brazil 5,000.00 BRL Line‐by‐line

(1) Set up in 2021

(2) Set up in 2022

(3) Acquired in 2022

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
EUSA
Pharma
(UK)
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
EUSA
Pharma
(UK)
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
RECORDATI RARE DISEASES
FZCO(2)
100.00 100.00
EUSA Pharma (UK) Limited(3) 100.00 100.00
EUSA Pharma (Italy) S.r.l. (3) 100.00 100.00
EUSA Pharma (France) S.A.S. (3) 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.
Recorda
ti Ilaç
A.Ş.
Opalia
Pharma
S.A.
Recordati
AG
EUSA
Pharma
(UK)
Total
EUSA Pharma Iberia S.L. (3) 100.00 100.00
EUSA Pharma (Germany)
GmbH(3)
100.00 100.00
EUSA Pharma (Netherlands)
B.V.(3)
100.00 100.00
EUSA Pharma (Denmark) ApS(3) 100.00 100.00
EUSA Pharma (US) LLC(3) 100.00 100.00
EUSA Pharma (Australia) Pty
Ltd(3)
100.00 100.00
EUSA Pharma (CH) GmbH(3) 100.00 100.00
EUSA Pharma Korea Ltd(3) 100.00 100.00
EUSA Pharma Brasil ‐ Marketing
e Promoçoes LTDA(3)
100.00 100.00

(1) Set up in 2021 (2) Set up in 2022 (3) Acquired in 2022

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, 8 November 2022

Luigi La Corte

Financial Reporting Manager

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