Quarterly Report • Oct 28, 2021
Quarterly Report
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AT 30 SEPTEMBER 2021
| Page | |
|---|---|
| MANAGEMENT REVIEW | 3 |
| Financial highlights | 3 |
| Corporate development news and other key events | 5 |
| Review of operations | 6 |
| Financial review | 11 |
| Business outlook | 15 |
| CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2021 and NOTES | 16 |
| STATEMENT FROM THE MANAGER RESPONSIBLE FOR PREPARING THE COMPANY'S FINANCIAL REPORTING |
48 |
This document contains forward‐looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward‐looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast as a result of a variety of reasons, most of which are beyond the Recordati group's control.
The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the Recordati group's activities, and therefore, as such, it is not intended as medical scientific indications or recommendations, nor as advertising.
| NET REVENUE | ||||||
|---|---|---|---|---|---|---|
| € (thousands) | First nine | First nine | 0B0B0BChange | |||
| months 2021 | % | months 2020 | % | 2021/2020 | % | |
| Total net revenue | 1,156,189 | 100.0 | 1,093,818 | 100.0 | 62,371 | 5.7 |
| Italy | 201,603 | 17.4 | 208,523 | 19.1 | (6,920) | (3.3) |
| International | 954,586 | 82.6 | 885,295 | 80.9 | 69,291 | 7.8 |
| KEY CONSOLIDATED P&L DATA | ||||||
| € (thousands) | First nine | First nine | 0B0B0BChange | |||
| months 2021% of revenue | months 2020 % of revenue | 2021/2020 | % | |||
| Net revenue | 1,156,189 | 100.0 | 1,093,818 | 100.0 | 62,371 | 5.7 |
| EBITDA(1) | 447,886 | 38.7 | 438,801 | 40.1 | 9,085 | 2.1 |
| Operating income | 372,927 | 32.3 | 364,037 | 33.3 | 8,890 | 2.4 |
| Net income | 296,386 | 25.6 | 274,100 | 25.1 | 22,286 | 8.1 |
| Adjusted net income (2) | 313,429 | 27.1 | 317,548 | 29.0 | (4,119) | (1.3) |
| KEY CONSOLIDATED BALANCE SHEET DATA | ||||||
| € (thousands) | 30 September | 31 December | 0B0B0BChange | % | ||
| 2021 | 2020 | 2021/2020 | ||||
| Net financial position(3) | (714,720) | (865,824) | 151,104 | (17.5) | ||
| Shareholders' equity | 1,445,068 | 1,276,260 | 168,808 | 13.2 | ||
| Third quarter 2021 | ||||||
| NET REVENUE | ||||||
| € (thousands) | Third quarter | Third quarter | 0B0B0BChange | |||
| 2021 | % | 2020 | % | 2021/2020 | % | |
| Total net revenue | 385,354 | 100.0 | 333,626 | 100.0 | 51,728 | 15.5 |
| Italy | 61,536 | 16.0 | 60,038 | 18.0 | 1,498 | 2.5 |
| International | 323,818 | 84.0 | 273,588 | 82.0 | 50,230 | 18.4 |
| KEY CONSOLIDATED P&L DATA | ||||||
| € (thousands) | Third quarter | Third quarter | 0B0B0BChange | |||
| 2021% of revenue | 2020 % of revenue | 2021/2020 | % | |||
| Net revenue | 385,354 | 100.0 | 333,626 | 100.0 | 51,728 | 15.5 |
| EBITDA(1) | 147,436 | 38.3 | 127,710 | 38.3 | 19,726 | 15.4 |
(1) Net income before income taxes, the provision for taxes, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
Operating income 122,559 31.8 102,527 30.7 20,032 19.5 Net income 89,280 23.2 77,157 23.1 12,123 15.7 Adjusted net income (2) 103,610 26.9 91,980 27.6 11,630 12.6
(2) Net income excluding the amortization and write‐downs of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
(3) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives.
The third quarter of 2021 confirmed the trends recorded during the second quarter, with a steady recovery in the Group's main reference markets and with operating conditions returning to near normal, even though limited access to medical personnel in several countries and social distancing measures continue to impact on certain product categories. This, combined with the contribution from the new product Eligard® and the continued growth in endocrinology products, resulted in a net revenue increase of 15.5% (+17% at constant exchange rate) in the third quarter compared to the same period in 2020, which had been more significantly impacted by the COVID 19 restriction measures.
Consolidated net revenue in the first nine months of 2021 was € 1,156.2 million compared to € 1,093.8 million in the same period the previous year (+5.7%), reflecting an adverse currency exchange rate effect of around € 31.7 million and the contribution from Eligard® for € 59.4 million (acquired under license from Tolmar International Ltd. in January). Net of these effects, growth was at 3.2%, which, however, reflects the loss of exclusivity in 2020 of silodosin and pitavastatin based products and the impact of the pandemic, especially on seasonal flu medications in the first part of 2021. The growth of the rare diseases portfolio was significant in the first nine months of 2021, at 20.2%, thanks especially to the increases in Signifor® and Isturisa®, but also to the solid performance of the main products in our portfolio.
EBITDA was € 447.9 million, up by 2.1% compared to the first nine months of 2020, accounting for 38.7% of revenue. Growth was driven by the solid revenue performance, which was partially offset by the increase in investments to support the growth of the rare diseases portfolio, the costs related to integrating and promoting the new product Eligard®, as well as the gradual recovery of activities in the field. It should be reiterated that margins in the first nine months of 2020 benefited from the sharp drop in operations in the territory following the introduction of restrictions on movement measures over most of this period.
Operating income was € 372.9 million, up by 2.4% over the same period of the previous year, at 32.3% of revenue.
Net income, at € 296.4 million, increased by 8.1% compared to the first nine months of 2020, with higher net financial expenses (due to exchange rate losses of € 6.8 million), and non‐recurring tax benefits recorded in the second quarter of € 26.2 million, of which € 12.9 million refer to the benefit from the completion of the reverse merger with Rossini Investimenti S.p.A. and Fimei S.p.A. and € 13.3 million from the release of deferred tax liabilities (net of substitute tax due) following the revaluation of the Magnesio Supremo® brand, carried out by the subsidiary Natural Point S.r.l. in application of the 2020 "August Decree" and subsequent amendments and the interpretations by the Italian Tax Authorities. Net income accounted for 25.6% of revenue.
Adjusted net income was € 313.4 million, down by 1.3% over the same period in 2020 due primarily to the higher net financial expenses, at 27.1% of revenue.
The net financial position at 30 September 2021 recorded net debt of € 714.7 million compared to net debt of € 865.8 million at 31 December 2020. Over the period, € 35.0 million was paid to Tolmar International Ltd. pursuant to the license agreement for Eligard® and € 14.5 million to Almirall S.A. for the Flatoril® license. Furthermore, treasury shares were purchased for € 29.0 million, net of sales proceeds from exercising stock options, and dividends were paid for € 109.4 million. Free cash flow, which is operating cash flow before excluding these effects and financing items was € 352.9 million for the period, an increase of € 69.6 million compared to the first nine months of 2020, thanks to the increase in operating results and careful management of working capital.
Shareholders' equity was € 1,445.1 million.
In January 2021, a License and Supply Agreement was finalized with Tolmar International Ltd to market Eligard® (leuprorelin acetate) in Europe, Turkey, Russia and other countries. Eligard® is a medicinal product for the treatment of advanced hormone‐dependent prostate cancer and for the treatment of high‐risk localized and locally advanced hormone‐dependent prostate cancer, in combination with radiotherapy. Already over the first nine months of the year, net revenue for € 59.4 million was recorded on the basis of this agreement. The active ingredient in Eligard®, leuprorelin acetate, presents in powder form, which is solubilized with a solvent and administered as a subcutaneous injection. Eligard® is available in three different doses (for 1 month, 3 months and 6 months of treatment, respectively) in a single kit containing two syringes.
Following a request from the European Medicines Agency (EMA), a new device is currently being developed to make administration of the product easier. The regulatory amendment should be submitted by the first quarter of 2022. Tolmar will continue to manufacture the product for Recordati, whereas Astellas will provide Recordati with certain transitory services over an agreed time period. At 30 September 2021, the transfer of the Marketing Authorization or sales licence for Recordati was completed in around 30 countries, and the product is marketed directly in 23 countries and via partners in a further 6 countries.
Recordati has made an upfront payment of € 35 million to Tolmar, with further milestones up to a total of € 105 million payable, plus royalties on sales.
Also in January 2021, the US Food and Drug Administration (FDA) approved a new indication for Carbaglu® (carglumic acid) 200 mg tablets as an adjunctive therapy to the primary treatment of acute hyperammonemia caused by propionic acidemia (PA) or by methylmalonic acidemia (MMA) in pediatric and adult patients. Carbaglu® is the first and only drug approved by the FDA for the treatment of acute hyperammonemia due to PA and MMA.
An agreement with Almirall S.A. was finalized in February 2021, to acquire the marketing rights on the Spanish market for Flatoril®, a medicine containing a combination of clebopride and simethicone, indicated for the treatment of functional gastrointestinal disorders.
In March 2021, in Japan, the Ministry of Health, Labour and Welfare (MHLW) approved Isturisa® (osilodrostat), for the treatment of patients with endogenous Cushing's syndrome for whom pituitary surgery is not an option or has not been curative. Marketing began at the end of June after having obtained the reimbursement price.
On 16 July 2021, the Board of Directors approved the new corporate governance structure of Recordati, which envisages the appointment of Rob Koremans as the new Chief Executive Officer (CEO), with effect from 1 December 2021. The current CEO, Andrea Recordati, will be appointed Chairman and will continue to be involved in formulating the Group strategy, providing support to the new CEO and senior management team. In light of other important appointments roles entrusted to him by the Italian Government and having completed the transition process towards a new Governance of the Company, similarly on 16 July 2021, Chairman Alfredo Altavilla tendered his resignation from office, effective 1 December 2021.
In October 2021, Recordati was included in the MIB ESG Index, the first index promoted by Euronext and Borsa Italiana, dedicated to blue‐chip companies demonstrating best ESG practices. The Group's inclusion in the index is further evidence of Recordati' firm commitment to environmental, social and governance issues. The index selects 40 listed Italian companies that stand out for their perfect integration of economic performance and ESG criteria, in line with the United Nations' Global Impact standards. It is work reiterating that Recordati is also included in the FTSE4Good Index series. As a testament to the Company's focus on sustainability, we note a general improvement in the ESG rating, including the CDP Climate Change program, MSCI, ISS and EcoVadis (the latter of which gave us a Gold rating in June 2021).
The Group's business involves two segments: Specialty and Primary Care medicines and treatments for rare diseases. Business is conducted through our subsidiaries in Europe, Russia, Turkey, North Africa, the United States of America, Canada, Mexico, certain South American countries, Japan and Australia and, in the rest of the world, based on licensing agreements with leading pharmaceutical companies.
Consolidated net revenue in the first nine months of 2021 was € 1,156.2 million compared to € 1,093.8 million in the first nine months the previous year (+5.7% or +8.6% at constant exchange rate). The revenue trend over the first nine months of 2021 compared to 2020 reflects the growth in the rare diseases portfolio (for metabolic as well as endocrine diseases), the contribution of € 59.4 million from Eligard® (the new product under license from Tolmar International Ltd. since January 2021) and the slight drop in Specialty and Primary Care products (net of the new product Eligard®). The latter is the result of the persistent impact of the COVID‐19 pandemic (in terms of the decreased demand for seasonal flu products and destocking by wholesalers) and the loss of exclusivity of silodosin and pitavastatin products during 2020. Of note, however, during the third quarter (and already in the second), Specialty & Primary Care products showed signs of recovery, increasing by 4.6% (or +6.3% at constant exchange rate) compared to the third quarter of 2020, (net of the new product Eligard®).
* Excluding sales of pharmaceutical chemicals, which were at € 35.4 million, down by 6.6%, representing 3.1% of total revenue.
The performance of products sold directly in more than one market (corporate products) during the first nine months of 2021 is shown in the table below and already reflects the effects of the pandemic referred to above.
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
6B6B4B% |
|---|---|---|---|---|
| Zanidip® (lercanidipine) | 107,193 | 106,083 | 1,110 | 1.0 |
| Zanipress® (lercanidipine+enalapril) | 31,307 | 38,234 | (6,927) | (18.1) |
| Urorec® (silodosin) | 45,265 | 58,488 | (13,223) | (22.6) |
| Livazo® (pitavastatin) | 31,849 | 42,450 | (10,601) | (25.0) |
| Seloken®/Seloken® ZOK/Logimax® (metoprolol/metoprolol + felodipine) |
72,991 | 77,699 | (4,708) | (6.1) |
| Eligard® (leuprorelin acetate) | 59,362 | ‐ | 59,362 | n.s. |
| Other corporate products* | 198,059 | 198,689 | (630) | (0.3) |
| Drugs for rare diseases | 279,386 | 232,359 | 47,027 | 20.2 |
* Include corporate OTC products for a total of € 79.3 million in 2021 and € 78.4 million in 2020 (+1.2%).
Zanidip® is a specialty containing lercanidipine, Recordati's original calcium channel blocker for the treatment of hypertension. Our lercanidipine‐based products are sold directly to the market by our marketing organizations in Europe, including Central ‐Eastern Europe, Russia, Turkey and North Africa. In the other countries and in some of the countries mentioned above with co‐marketing agreements, they are sold by our licensees.
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
8B8B6B% |
|---|---|---|---|---|
| Direct sales | 53,661 | 57,551 | (3,890) | (6.8) |
| Sales to licensees | 53,532 | 48,532 | 5,000 | 10.3 |
| Total lercanidipine sales | 107,193 | 106,083 | 1,100 | 1.0 |
Direct sales of lercanidipine were down by 6.8% in the first nine months of 2021, mainly due to the drop in volume in Italy and the effect of the generic product entering the Turkish market, in addition to the adverse currency exchange rate effect due the devaluation of the Turkish lira). Sales to licensees, representing 49.9% of the total, grew primarily due to initial sales to a new licensee in China.
Zanipress® is an original pharmaceutical specialty developed by Recordati, indicated for the treatment of hypertension, consisting of a fixed combination of lercanidipine and enalapril. This product is successfully marketed directly by Recordati or by its licensees in 60 countries.
| Total lercanidipine+enalapril sales | 31,307 | 38,234 | (6,927) | (18.1) |
|---|---|---|---|---|
| Sales to licensees | 3,832 | 4,117 | (285) | (6.9) |
| Direct sales | 27,475 | 34,117 | (6,642) | (19.5) |
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
10B10B8B% |
Direct sales of Zanipress® were down by 19.5% in the first nine months of 2021, mainly due to competition from the generic formulations and adverse currency exchange with Turkey. Sales to licensees, representing 12.2% of the total, came down slightly.
Urorec® (silodosin) is a specialty indicated for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). Currently, the product is marketed in 56 countries, with sales of € 45.3 million in the first nine months of 2021, down by 22.6% due to competition from generic versions of the product following the expiry of its marketing exclusivity, in February 2020. Of note are the increased sales in Switzerland and Central‐Eastern European countries compared to the same period in 2020.
Livazo® (pitavastatin), a statin indicated to lower elevated total and LDL cholesterol and sold directly in Spain, Portugal, Ukraine, Greece, Switzerland, Russia, other C.I.S. countries and Turkey, recorded sales for € 31.8 million in the first nine months of 2021, down by 25.0% due to the loss of exclusivity in August 2020. Regardless, there was growth in local currency in Turkey and Russia.
Sales of Seloken® /Seloken® ZOK (metoprolol) and Logimax® fixed dose combination (metoprolol and felodipine), metoprolol‐based specialties belonging to the beta blocker class of drugs widely used in the treatment of various cardiovascular disorders, were at € 73.0 million in the first nine months of 2021, down by 6.1% compared to the same period of the previous year, due to the sharp increase in sales in Central‐Eastern European countries in 2020, especially Poland (due to the temporary reduction in the availability of products from the competition) and Germany.
Revenue for Eligard® was at € 59.4 million for the first nine months of 2021. This amount includes the direct sales made by Recordati and the gross profit realized by Astellas Pharma Europe S.A. (licensee of the product in Europe, Turkey, Russia and other countries up until 31 December 2020) and transferred to Recordati on the basis of the Transfer Service Agreement (TSA). In countries falling under the license contract with Tolmar International S.A. and where Recordati has not yet obtained transfer of the relevant Marketing Authorization or sales license, Astellas continues to sell the product and retrocede the relative gross profit (net of the expenses agreed in the TSA). At 30 September 2021, the transfer of the Marketing Authorization or sales license for Recordati occurred in most countries subject to the licence agreement with Tolmar, except for Russia and Ukraine.
In the first nine months of 2021, sales of other corporate products totalled € 198.1 million, remaining essentially in line with the same period of the previous year, confirming the positive performance in the third quarter of 2021 and which was already evident during the second quarter. In particular, the drop continued for the Hexa and polidexa, which was however counterbalanced by the sound performance of Procto‐Glyvenol (+13.5%), Reagila® (+25.6%), CitraFleet® (+24.5%), Casenlax® (+22.1%) and Fleet enema (+18.2%). Other corporate products comprise prescription as well as OTC products and include: Reagila® (cariprazine), Lomexin® (fenticonazole), Urispas® (flavoxate), Kentera® (transdermal oxybutynin), TransAct® LAT (transdermal flurbiprofen), Rupafin®/Wystamm® (rupatadine), Lopresor® (metoprolol), Procto‐Glyvenol® (tribenoside), Tergynan® (fixed combination of anti‐infectives), in addition to CitraFleet®, Casenlax®, Fleet enema, Fosfosoda®, Reuflor®/Reuteri® (lactobacillus reuteri) and Lacdigest® (tilactase), the gastroenterology products, Polydexa®, Isofra® and Otofa®, othorynolaringological anti‐infectives, the Hexa product range for seasonal ailments of the upper respiratory tract, Abufene® and Muvagyn® gynacological disorders, Virirec® (alprostadil) and Fortacin® (lidocaine+prilocaine), for andrological disorders.
In the first nine months of 2021, our specialties for the treatment of rare diseases, marketed directly in Europe, the Middle East, the U.S.A., Canada, Mexico and some South American countries, Japan, Australia and through partners in other territories, generated sales of € 279.4 million, up by 20.2%, thanks especially to growth in revenue from Signifor®, Signifor® LAR and Isturisa® for a total of € 90.5 million compared to € 53.8 million during
the same period in 2020. Cystadrops® and Cystadane® as well as Ledaga® and Juxtapid® also recorded positive growth over the period.
Sales of pharmaceutical chemicals, which comprise active substances produced in the Campoverde di Aprilia plant in Italy for the international pharmaceutical industry, were at € 35.4 million, down by 6.6%, representing 3.1% of total revenue.
Sales from the Recordati subsidiaries, which include the above‐mentioned product sales but exclude sales of pharmaceutical chemicals, are shown in the table below.
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
12B12B10B% |
|---|---|---|---|---|
| Italy | 195,817 | 202,898 | (7,081) | (3.5) |
| France | 112,204 | 109,132 | 3,072 | 2.8 |
| Germany | 111,727 | 100,595 | 11,132 | 11.1 |
| U.S.A. | 127,509 | 89,418 | 38,091 | 42.6 |
| Russia, other C.I.S. countries and Ukraine | 63,447 | 69,089 | (5,642) | (8.2) |
| Spain | 85,855 | 63,079 | 22,776 | 36.1 |
| Turkey | 53,508 | 62,443 | (8,935) | (14.3) |
| Portugal | 33,480 | 32,557 | 923 | 2.8 |
| Other Western European countries | 75,871 | 66,864 | 9,007 | 13.5 |
| Other C.E.E. countries | 80,281 | 67,098 | 13,183 | 19.6 |
| North Africa | 27,333 | 33,372 | (6,039) | (18.1) |
| Other international sales | 153,726 | 159,341 | (5,615) | (3.5) |
| Total net pharmaceutical revenue* | 1,120,758 | 1,055,886 | 64,872 | 6.1 |
*Net revenue includes the sales of products and various revenue and excludes revenue from pharmaceutical chemical products.
Sales in countries affected by currency exchange fluctuations are shown below in their relative local currencies.
| Local currency (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
13B14B% |
|---|---|---|---|---|
| Russia (RUB) | 4,040,288 | 4,276,804 | (236,516) | (5.5) |
| Turkey (TRY) | 478,682 | 450,265 | 28,417 | 6.3 |
| United States of America (USD) | 152,529 | 100,598 | 51,931 | 51.6 |
Net revenue in Russia excludes sales of rare disease products.
Sales of pharmaceutical specialties in Italy were at € 195.8 million, down by 3.5% compared to the same period the previous year. This was mainly due to the decline in seasonal flu‐related prescription medication and the decrease in sales of Urorec® due to the loss of exclusivity. Of note is the solid performance of Reagila® and the main OTC products, the positive performance of Eligard®, as well as the growth of sales in the rare diseases portfolio, amounting to € 14.6 million, up by 3.3%.
Sales for € 112.2 million were recorded in France, up by 2.8%, mainly due to the significant growth in sales of products for the treatment of rare diseases, amounting to € 24.6 million (+7.4%). The Specialty and Primary Care product portfolio was down, reflecting the persistent impact of the COVID‐19 emergency, primarily on the Hexa seasonal flu product range and the loss of exclusivity of Urorec® (silodosin), which was partially offset by growth in Eligard®, metadone and the initial sales of Reselip®.
Sales in Germany equalled € 111.7 million and were up by 11.1%, thanks to growth in the Specialty and Primary Care product portfolio (in particular, Ortoton Forte®, Laxbene and Eligard®, which offset the decrease in metoprolol), as well as the rare diseases portfolio, for € 15.0 million (+14.6%).
Sales generated in Russia, Ukraine and in the countries within the Commonwealth of Independent States (C.I.S.) were at € 63.4 million, down by 8.2% compared to the same period the previous year, but recovering in the second and third quarters, and include estimated currency exchange losses of € 6.0 million. Revenue realized in Russia was RUB 4,040.3 million in local currency, down by 5.5% over the same period the previous year. The lower volume is due to the product portfolio's exposure to seasonal flu conditions and the policy implemented by wholesalers in the first half of 2021 to reduce inventories compared to pre‐pandemic levels, with an average decrease in inventories. Revenue generated in Ukraine and the other C.I.S. countries, mainly Belarus, Kazakhstan and Armenia, grew to € 13.6 million. Sales of products for the treatment of rare diseases, amounting to € 3.7 million, increased sharply compared to the same period in 2020.
The Group's pharmaceutical business in the U.S.A. is dedicated to marketing products for the treatment of rare diseases. Sales were at € 127.5 million in the first nine months of 2021, up by 42.6%. In local currency, sales grew by 51.6%. Growth was mainly due to Signifor®, Signifor® LAR, Isturisa® (osilodrostat). Panhematin (hemin for injection) sales also grew over the period, having dropped during the months of the pandemic. The other main products in the US portfolio are Carbaglu®, Cystadrops®, Cystadane® (betaine anhydrous) and Cosmegen® (dactinomycin for injection), used in the treatment of three rare cancers.
Sales in Turkey were at € 53.5 million, down by 14.3%, and included a adverse currency exchange effect estimated at € 13.6 million. Sales in Turkey were up by 6.3% in local currency, mainly due to the growth in sales of products for the treatment of rare diseases, amounting to € 4.3 million (+34.3%). Sales in the Specialty and Primary Care segment were impacted by the decrease in the market for seasonal flu products and competition from local and generic products, which especially affected sales of Zanidip®, Zanipress®, Mictonorm® and Cabral®.
Sales in Spain equalled € 85.9 million, up by 36.1%, mainly due to the contribution of Eligard® and the rare diseases portfolio, amounting to € 10.0 million, which grew by 16.0%. Gastrointestinal products performed well, after being effected by impact of the pandemic in 2020. Following the acquisition from Almirall, the first sales of Flatoril® for € 2.1 million were recorded. After losing exclusivity in 2020, sales of Livazo® and Urorec® fell by 45.5% and 7.0% respectively over the same period of the previous year.
Sales in Portugal were at € 33.5 million, increasing by 2.8% compared to the same period the previous year. Drugs for the treatment of rare diseases, amounting to € 1.4 million, grew by 14.9%. After losing exclusivity in 2020, sales of Livazo® and Urorec® fell by 53.8% and 32.6% respectively compared to the first nine months of the previous year. These losses were, however, offset by the new product Eligard® and increased sales of Reagila®.
Sales in other Central and Eastern European countries, at € 80.3 million, include the sales from Recordati subsidiaries in Poland, the Czech Republic and Slovakia, Romania, Bulgaria and the Baltic countries, in addition to sales of rare disease treatments in this area, as well as in Hungary. In the first nine months of 2021, sales were up by 19.6% in total, thanks to the contribution of Eligard® and the growth of Procto‐Glyvenol®, coupled with the 33.3% increase in the rare diseases portfolio, at € 6.8 million.
Sales in other Western European countries totalled € 75.9 million, increasing by 13.5%. They include sales of products for rare diseases and Specialty and Primary Care products from the Recordati subsidiaries in the United Kingdom, Ireland, Greece, Switzerland, Nordic countries (Finland, Sweden, Denmark, Norway and Iceland) and in BeNelux. Sales of Specialty & Primary Care products grew mainly thanks to Eligard®. Sales of products for the treatment of rare diseases in this area, amounting to € 21.2 million, increased by 3.1%.
Sales in North Africa totalled € 27.3 million, down by 18.1% compared to the same period of the previous year, due to the failure to renew the importing licence in Algeria for Hexaspray and vitamin D3. This includes the foreign revenue generated by Laboratoires Bouchara Recordati in these territories and the sales generated by Opalia Pharma, the Group's Tunisian subsidiary. Sales in Tunisia in the first nine months of 2021 were up by 5.9%.
Other international sales, for € 153.7 million, were down by 3.5% compared to the same period the preceding year and comprise sales and other revenue from our licensees for our corporate products, Laboratoires Bouchara Recordati's and Casen Recordati's export sales, as well as sales of products for the treatment of rare diseases in the rest of the world. The drop is mainly due to the impact on sales to licensees of silodosin and pitavastatin‐ based products (where the Group lost marketing exclusivity in 2020) and termination of the Kentera® distribution contract under license with Teva.
Income statement items are shown in the table below, with the relative percentage of net revenue and changes compared to the first nine months of 2020:
| € (thousands) | First nine months 2021 |
% of revenue |
First nine months 2020 |
% of revenue |
0B0B0BChange 2021/2020 |
% |
|---|---|---|---|---|---|---|
| Net revenue | 1,156,189 | 100.0 | 1,093,818 | 100.0 | 62,371 | 5.7 |
| Cost of sales | (313,005) | (27.1) | (308,237) | (28.2) | (4,768) | 1.5 |
| Gross profit | 843,184 | 72.9 | 785,581 | 71.8 | 57,603 | 7.3 |
| Selling expenses | (287,007) | (24.8) | (256,701) | (23.5) | (30,306) | 11.8 |
| Research and development expenses |
(119,691) | (10.4) | (106,344) | (9.7) | (13,347) | 12.6 |
| General and administrative expenses |
(60,057) | (5.2) | (53,644) | (4.9) | (6,413) | 12.0 |
| Other income/(expenses), net | (3,502) | (0.3) | (4,855) | (0.4) | 1,353 | (27.9) |
| Operating income | 372,927 | 32.3 | 364,037 | 33.3 | 8,890 | 2.4 |
| Financial income/(expenses), net | (22,191) | (1.9) | (11,192) | (1.0) | (10,999) | 98.3 |
| Pre‐tax income | 350,736 | 30.3 | 352,845 | 32.3 | (2,109) | (0.6) |
| Income taxes | (54,350) | (4.7) | (78,745) | (7.2) | 24,395 | (31.0) |
| Net income | 296,386 | 25.6 | 274,100 | 25.1 | 22,286 | 8.1 |
| Adjusted net income (1) | 313,429 | 27.1 | 317,548 | 29.0 | (4,119) | (1.3) |
| EBITDA(2) | 447,886 | 38.7 | 438,801 | 40.1 | 9,085 | 2.1 |
(1) Net income excluding the amortization and write‐downs of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
(2) Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
Net revenue amounted to € 1,156.2 million, up by € 62.4 million compared to the first nine months of 2020. For a detailed analysis, please refer to the previous chapter "Review of Operations".
Gross profit was € 843.2 million, at 72.9% of sales, an improvement over the same period the previous year, mainly due to the positive effect from the increased impact of the rare diseases portfolio and recording the indirect sales margins for the new product Eligard® during the first six months of 2021.
Selling expenses increased by 11.8% compared to the first nine months of 2020, mainly due to the royalties paid to Tolmar International Ltd. for the new product Eligard® as well as the administrative charges payable to Astellas for the countries where Recordati's authorization to sell Eligard® has not yet been transferred. Marketing expenses also increased, mainly due to the launch of Isturisa®.
Research and development expenses were at € 119.7 million, increasing by 12.6% over the first nine months of last year, mainly due to the investments to support endocrinology products and increased amortizations on the rights for Isturisa®, launched in the second quarter of 2020, and for Eligard®, acquired under license from Tolmar International in January 2021.
General and administrative expenses increased by 12.0% to strengthen the general coordination structure to support an increasingly complex portfolio and specifically to support the management of Signifor®, Isturisa® and Eligard® products, which are expected to record sustained growth in 2021 and into the future.
Other net expenses amounted to € 3.5 million, compared to € 4.9 million in the first nine months of 2020. In both periods, these refer mainly to non‐recurring costs related to the COVID‐19 health emergency (at € 1.8 million in
2021 and € 5.2 million in 2020).
EBITDA (net income before income taxes, financial income and expenses, depreciation, amortization and write‐ downs of property, plant and equipment, intangible assets and goodwill, and non‐recurring items) totalled € 447.9 million, up by 2.1% compared to the same period in 2020, at 38.7% of revenue. The amortization items classified above equalled € 72.9 million, of which € 54.0 million related to intangible assets, up by € 3.4 million over the same period the previous year, due to the launch of Isturisa® in the second quarter of 2020, the license contract with Tolmar International for Eligard® in January 2021, and € 18.9 million relating to property, plant and equipment, down by € 0.1 million over the first nine months of 2020.
The reconciliation of net income and EBITDA is reported below.
| € (thousands) | First nine months 2021 |
First nine months 2020 |
|---|---|---|
| Net income | 296,386 | 274,100 |
| Income taxes | 54,350 | 78,745 |
| Financial income/(expenses), net | 22,191 | 11,192 |
| Depreciation and amortization | 72,896 | 69,582 |
| Non‐recurring operating expenses | 2,063 | 5,182 |
| EBITDA* | 447,886 | 438,801 |
* Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
10B10B8B% |
|---|---|---|---|---|
| Specialty and Primary Care segment | 315,536 | 321,823 | (6,287) | (2.0) |
| Rare diseases segment | 132,350 | 116,978 | 15,372 | 13.1 |
| Total EBITDA* | 447,886 | 438,801 | 9,085 | 2.1 |
* Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
Net financial expenses amounted to € 22.2 million, increasing by € 11.0 million over the same period the previous year and include net exchange losses for € 6.8 million and lower income compared to the first nine months of 2020, when a net benefit of € 2.6 million was recorded from the repayment of the two intercompany loans and the related cross‐currency swaps.
The effective tax rate was 15.5%, which was significantly lower than the same period the previous year. Two non‐ recurring tax benefits were recorded in the first nine months of 2021, for a total of € 26.2 million. As envisaged in the merger project, following the incorporation of its subsidiaries, Recordati S.p.A. inherited the ACE (Allowance for Corporate Equity) accrued by Rossini Investimenti S.p.A. for € 12.9 million. Furthermore, the revaluation of the Magnesio Supremo® brand by the subsidiary Natural Point S.r.l., with tax effects from 2021, resulted in the alignment between the accounting and tax amounts, and consequent release of the residual deferred tax liabilities to the income statement, calculated in the scope of the Purchase Price Allocation conducted for accounting
purposes in the consolidated financial statements at the time of acquiring the subsidiary, impacting positively on the income statement for € 13.3 million, net of the substitute tax for € 1.6 million.
Net income, at € 296.4 million and 25.6% of revenue, increased by 8.1% compared to the first nine months of 2020 thanks to the contribution of operating income and non‐recurring tax benefits for € 26.2 million referred to above, which were partially offset by higher financial expenses.
Adjusted net income was € 313.4 million and excludes amortization and write‐downs of intangible assets (except software) and goodwill for an amount of € 41.7 million, non‐recurring operating expenses for € 1.5 million, both net of tax effects, as well as the non‐recurring tax income for € 26.2 million in the first half of 2021.
The reconciliation of net income with adjusted net income* is reported below.
| € (thousands) | First nine months 2021 |
First nine months 2020 |
|---|---|---|
| Net income | 296,386 | 274,100 |
| Amortization and write‐downs of intangible assets (excluding software) |
52,748 | 50,371 |
| Tax effect | (10,996) | (10,732) |
| Non‐recurring operating expenses | 2,063 | 5,182 |
| Tax effect | (554) | (1,373) |
| Non‐recurring tax income | (26,218) | 0 |
| Adjusted net income* | 313,429 | 317,548 |
* Net income excluding amortization and write‐downs of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
| € (thousands) | 30 September 2021 |
31 December 2020 |
Change 2021/2020 |
% |
|---|---|---|---|---|
| Cash and cash equivalents | 341,926 | 188,230 | 153,696 | 81.7 |
| Short‐term debts to banks and other lenders | (13,478) | (12,567) | (911) | 7.2 |
| Loans ‐ due within one year(1) | (219,694) | (261,216) | 41,522 | (15.9) |
| Leasing liabilities ‐ due within one year | (8,474) | (9,038) | 564 | (6.2) |
| Short‐term financial position | 100,280 | (94,591) | 194,871 | n.s. |
| Loans ‐ due after one year (1) | (799,264) | (753,582) | (45,682) | 6.1 |
| Leasing liabilities ‐ due after one year | (15,736) | (17,651) | 1,915 | (10.8) |
| Net financial position | (714,720) | (865,824) | 151,104 | (17.5) |
(1) Includes the fair value measurement of the relative currency risk hedging instruments (cash flow hedge)
The net financial position at 30 September 2021 recorded debt of € 714.7 million compared to debt of € 865.8 million at 31 December 2020. Over the period, € 35.0 million was paid to Tolmar International pursuant to the license agreement for Eligard® and € 14.5 million to Almirall S.A. for the Flatoril® license. Furthermore, treasury shares were purchased for € 29.0 million, net of sales proceeds from exercising stock options, and dividends were paid for € 109.4 million. Free cash flow, which is operating cash flow before excluding these effects and financial
items, was € 352.9 million, an increase of € 69.6 million compared to the first nine months of 2020. The ratio of Net Debt/EBITDA (for the last 12 months) was 1.24.
In April, the merger deed was drafted for the merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. The subsequent filing with the Companies Register has finalized the transaction, with tax and accounting effects from 1 April 2021. The merger, approved by the Shareholders' Meeting on 17 December 2020, did not change the share capital of the incorporating company, nor any balancing cash payment. Furthermore, after the merger, Recordati S.p.A.'s balance sheet and earnings profile remained essentially consistent with prior to the transaction and, in particular, the merger did not alter Recordati's net financial position or, therefore, its investment capacity, or its capital allocation strategy or policy. As provided for in the draft terms of merger, Recordati S.p.A. inherited the ACE base and the ACE surplus of Rossini Investimenti S.p.A., with a non‐recurring positive tax effect in 2021 of € 12.9 million and a recurring tax benefit of approximately € 1.2 million per year. ACE (Allowance for Corporate Equity) is tax relief for companies governed by Art. 1 of Italian Decree Law no. 201/2011 and by Italian Ministerial Decree 3/8/2017, and consists of the taxation of part of the taxable income proportional to the increases in equity. The merger also extinguished group taxation between Recordati S.p.A. and FIMEI S.p.A., and established that tax consolidation will continue between Recordati S.p.A. (as the consolidating company) and Italchimici S.p.A.
Following the transaction, the Group's immediate parent is Rossini S.à r.l., with headquarters in Luxembourg, which is owned by a consortium of investment funds controlled by CVC Capital Partners.
Financial results for the first nine months of the year reflect a gradual recovery of our relevant markets in recent months and are in line with expectations set at the beginning of the year, which foresaw for 2021 revenue of between € 1,570 million and € 1,620 million, EBITDA(1) of between € 600 and € 620 million and adjusted net income(2) between € 420 and € 440 million. Based on current trends, we expect results for the financial year at the lower end of the range, with the recent recovery in the seasonal flu‐market unlikely to fully offset the adverse impact in the first part of the year, assuming no significant new waves of COVID‐19 restrictions.
(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write‐downs of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
(2) Net income excluding amortization and write‐downs of intangible assets (except for software) and goodwill, and non‐recurring items, net of the tax effects.
Milan, 28 October 2021
for the Board of Directors Chief Executive Officer Andrea Recordati
CONSOLIDATED INCOME STATEMENT
| € (thousands) (1) | Note | First nine months 2021 |
First nine months 2020 |
|---|---|---|---|
| Net revenue | 3 | 1,156,189 | 1,093,818 |
| Cost of sales | 4 | (313,005) | (308,237) |
| Gross profit | 843,184 | 785,581 | |
| Selling expenses | 4 | (287,007) | (256,701) |
| Research and development expenses | 4 | (119,691) | (106,344) |
| General and administrative expenses | 4 | (60,057) | (53,644) |
| Other income/(expenses), net | 4 | (3,502) | (4,855) |
| Operating income | 372,927 | 364,037 | |
| Financial income/(expenses), net | 5 | (22,191) | (11,192) |
| Pre‐tax income | 350,736 | 352,845 | |
| Income taxes | 6 | (54,350) | (78,745) |
| Net income | 296,386 | 274,100 | |
| Attributable to: | |||
| Equity holders of the Parent | 296,386 | 274,063 | |
| Non‐controlling interests | 0 | 37 | |
| Earnings per share | |||
| Basic | € 1.439 | € 1.333 | |
| Diluted | € 1.417 | € 1.311 |
(1) Except amounts per share.
Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,919,516 in 2021 and 205,603,780 in 2020. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,205,640 shares in 2021 and 3,521,376 shares in 2020.
Diluted earnings per share is calculated taking into account stock options granted to employees.
CONSOLIDATED BALANCE SHEET
| ASSETS | |||
|---|---|---|---|
| € (thousands) | Note | 30 September | 31 December |
| 2021 | 2020 | ||
| Non‐current assets | |||
| Property, plant and equipment | 7 | 132,992 | 133,250 |
| Intangible assets | 8 | 1,128,036 | 1,115,811 |
| Goodwill | 9 | 560,309 | 562,116 |
| Other equity investments and securities | 10 | 41,963 | 45,581 |
| Other non‐current assets | 11 | 31,927 | 6,861 |
| Deferred tax assets | 12 | 76,203 | 75,084 |
| Total non‐current assets | 1,971,430 | 1,938,703 | |
| Current assets | |||
| Inventories | 13 | 244,501 | 251,252 |
| Trade receivables | 13 | 300,769 | 268,897 |
| Other receivables | 13 | 44,880 | 47,291 |
| Other current assets | 13 | 15,018 | 10,245 |
| Derivative instruments measured at fair value | 14 | 11,021 | 7,036 |
| Cash and cash equivalents | 15 | 341,926 | 188,230 |
| Total current assets | 958,115 | ||
| 772,951 | |||
| Total assets | 2,929,545 | 2,711,654 |
CONSOLIDATED BALANCE SHEET
| € (thousands) | Note | 30 September 2021 |
31 December 2020 |
|---|---|---|---|
| Shareholders' equity | |||
| Share capital | 26,141 | 26,141 | |
| Share premium reserve | 83,719 | 83,719 | |
| Treasury shares | (98,924) | (87,516) | |
| Reserve for derivative instruments | (1,584) | (2,659) | |
| Translation reserve | (205,169) | (217,303) | |
| Other reserves | 67,289 | 70,707 | |
| Profits carried forward | 1,277,210 | 1,151,053 | |
| Net income | 296,386 | 354,984 | |
| Interim dividend | 0 | (103,143) | |
| Shareholders' equity attributable to equity holders of the | |||
| Parent | 1,445,068 | 1,275,983 | |
| Shareholders' equity attributable to non‐controlling interests | 0 | 277 | |
| Total shareholders' equity | 16 | 1,445,068 | 1,276,260 |
| Non‐current liabilities | |||
| Loans ‐ due after one year | 17 | 824,701 | 778,238 |
| Provisions for employee benefits | 18 | 21,351 | 21,174 |
| Deferred tax liabilities | 19 | 27,787 | 41,219 |
| Other non‐current liabilities | 20 | 0 | 16,299 |
| Total non‐current liabilities | 873,839 | 856,930 | |
| Current liabilities | |||
| Trade payables | 21 | 166,917 | 132,096 |
| Other payables | 21 | 133,098 | 95,671 |
| Tax liabilities | 21 | 40,197 | 29,743 |
| Other current liabilities | 21 | 8,414 | 11,250 |
| Provisions for risks and charges | 21 | 14,240 | 17,113 |
| Derivative instruments measured at fair value | 22 | 6,126 | 9,770 |
| Loans ‐ due within one year | 17 | 228,168 | 270,254 |
| Short‐term debts to banks and other lenders | 23 | 13,478 | 12,567 |
| Total current liabilities | 610,638 | 578,464 | |
| Total shareholders' equity and liabilities | 2,929,545 | 2,711,654 |
STATEMENT OF CONSOLIDATED COMPREHENSIVE INCOME
| € (thousands) (1) | First nine months | First nine months |
|---|---|---|
| 2021 | 2020 | |
| Net income | 296,386 | 274,100 |
| Gains/(losses) on cash flow hedges, net of tax effects | 1,075 | 2,303 |
| Gains/(losses) on translation of foreign financial statements | 12,134 | (60,466) |
| Gains/(losses) on equity‐accounted investees, net of tax effects | (3,353) | (9,333) |
| Other changes, net of tax effects | (57) | (208) |
| Income and expenses recognized in shareholders' equity | 9,799 | (67,704) |
| Comprehensive income | 306,185 | 206,396 |
| Attributable to: | ||
| Equity holders of the Parent | 306,185 | 206,359 |
| Non‐controlling interests | 0 | 37 |
| Per share value | ||
| Basic | € 1.487 | € 1.004 |
| Diluted | € 1.464 | € 0.987 |
(1) Except amounts per share.
Earnings per share (EPS) are based on average shares outstanding during the respective period, 205,919,516 in 2021 and 205,603,780 in 2020. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,205,640 shares in 2021 and 3,521,376 shares in 2020.
Diluted earnings per share is calculated taking into account stock options granted to employees.
CONSOLIDATED STATEMENT OF CHANGE IN SHAREHOLDERS' EQUITY
| Shareholders' equity attributable to equity holders of the Parent | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| € (thousands) | Share capital |
Share premium reserve |
Treasury shares |
Reserve for derivative instruments |
Translation reserve |
Other reserves |
Profits carried forward |
Net income |
Interim dividend |
Non‐ controlling interests |
Total |
| Balance at 31 December 2019 |
26,141 | 83,719 | (93,480) | (5,357) | (146,866) | 64,651 | 999,708 | 368,825 (98,764) | 234 | 1,198,811 | |
| Allocation of 2019 net | |||||||||||
| income | 368,825 | (368,825) | |||||||||
| Dividend distribution | (205,423) | 98,764 | (106,659) | ||||||||
| Change in share‐based payments |
(285) | 3,934 | 3,649 | ||||||||
| Purchase of treasury shares | (47,871) | (47,871) | |||||||||
| Sale of treasury shares | 49,056 | (16,817) | 32,239 | ||||||||
| Other changes | 1,010 | 1,010 | |||||||||
| Comprehensive income | 2,303 | (60,466) | (9,541) | 274,063 | 37 | 206,396 | |||||
| Balance at 30 September 2020 |
26,141 | 83,719 | (92,295) | (3,054) | (207,332) | 54,825 1,151,237 | 274,063 | 0 | 271 | 1,287,575 | |
| Balance at 31 December 2020 |
26,141 | 83,719 | (87,516) | (2,659) | (217,303) | 70,707 1,151,053 | 354,984 (103,143) | 277 | 1,276,260 | ||
| Allocation of 2020 net income |
354,984 | (354,984) | |||||||||
| Dividend distribution | (216,123) | 103,143 | (112,980) | ||||||||
| Change in share‐based payments |
(400) | 4,021 | 3,621 | ||||||||
| Purchase of treasury shares | (66,891) | (66,891) | |||||||||
| Sale of treasury shares | 55,483 | (17,620) | 37,863 | ||||||||
| Other changes | 392 | 895 | (277) | 1,010 | |||||||
| Comprehensive income | 1,075 | 12,134 | (3,410) | 296,386 | 306,185 | ||||||
| Balance at 30 September 2021 |
26,141 | 83,719 | (98,924) | (1,584) | (205,169) | 67,289 1,277,210 | 296,386 | 0 | 0 | 1,445,068 |
CONSOLIDATED CASH FLOW STATEMENT
| € (thousands) | First nine | First nine |
|---|---|---|
| months 2021 | months 2020* | |
| OPERATING ACTIVITIES | ||
| Net income | 296,386 | 274,100 |
| Income taxes | 54,350 | 78,745 |
| Net interest | 13,326 | 12,710 |
| Depreciation of property, plant and equipment | 18,928 | 18,975 |
| Amortization of intangible assets | 53,968 | 50,607 |
| Equity‐settled share‐based payment transactions | 3,621 | 3,649 |
| Other non‐monetary components | 2,211 | 1,648 |
| Change in other assets and other liabilities | (14,632) | (18,951) |
| Cash flow generated/(used) by operating activities | ||
| before change in working capital | 428,158 | 421,483 |
| Change in: | ||
| - inventories |
7,837 | (43,361) |
| - trade receivables |
(29,721) | 7,892 |
| - trade payables |
34,730 | (33,294) |
| Change in working capital | 12,846 | (68,763) |
| Interest received | 214 | 440 |
| Interest paid | (11,476) | (11,653) |
| Income taxes paid | (61,599) | (45,012) |
| Cash flow generated/(used) by operating activities | 368,143 | 296,495 |
| INVESTMENT ACTIVITIES | ||
| Investments in property, plant and equipment | (15,344) | (13,213) |
| Disposals of property, plant and equipment | 158 | 0 |
| Investments in intangible assets | (61,400) | (93,164) |
| Disposals of intangible assets | 0 | 57 |
| Acquisition of holdings in subsidiaries | (304) | 0 |
| Cash flow generated/(used) by investment activities | (76,890) | (106,320) |
| FINANCING ACTIVITIES | ||
| Opening of loans | 219,065 | 110,183 |
| Repayment of loans | (216,381) | (74,237) |
| Payment of lease liabilities | (7,203) | (7,246) |
| Change in short‐term debts to banks and other lenders | (762) | 1,672 |
| Dividends paid | (109,389) | (110,541) |
| Purchase of treasury shares | (66,891) | (47,871) |
| Sale of treasury shares | 37,863 | 32,239 |
| Cash flow generated/(used) by financing activities | (143,698) | (95,801) |
| Change in cash and cash equivalents | 147,555 | 94,374 |
| Opening cash and cash equivalents | 188,230 | 187,923 ** |
| Currency translation effect | 5,662 | (4,675) |
| Effect of merger | 479 | 0 |
| Closing cash and cash equivalents | 341,926 | 277,622 ** |
* The 2020 figures were restated following the adoption of a new recognition method with the objective of better representing Group cash flow. These changes did not lead to significant changes in cash flow balances in terms of operating, investment, or financing activities as compared to what the cash flow statement showed last year.
** In 2020, the amounts net of short‐term debts to banks and other lenders were shown, equal to € 13,392 thousand at 31 December 2019 and € 14,729 thousand at 30 September 2020.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2021
The Interim Report for the Recordati Group for the period ended 30 September 2021 was prepared by Recordati Industria Chimica e Farmaceutica S.p.A. (the "Company" or the "Parent Company"), with headquarters in Milan at Via Matteo Civitali no. 1, was approved by the Board of Directors' meeting of 28 October 2021, which authorized distribution to the public.
The Interim Financial Statements at 30 September 2021 include the economic‐equity position of the Parent Company and all its subsidiaries. The companies included in the scope of consolidation, their percentage of ownership and a description of their activity are set out in Note 28.
In April, the merger deed was drafted for the merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. The subsequent filing with the Companies Register has finalized the transaction, with tax and accounting effects from 1 April 2021. The merger, approved by the Shareholders' Meeting on 17 December 2020, did not change the share capital of the incorporating company, nor any balancing cash payment. Furthermore, after the merger, Recordati S.p.A.'s balance sheet and earnings profile remained essentially consistent with prior to the transaction and, in particular, the merger did not alter Recordati's net financial position or, therefore, its investment capacity, or its capital allocation strategy or policy. The table below shows the effects of the merger on the Group's equity position at 1 April 2021.
| € (thousands) | ASSETS | SHAREHOLDERS' EQUITY AND LIABILITIES |
|
|---|---|---|---|
| Non‐current assets | Shareholders' equity | ||
| Other equity investments | |||
| and securities | 3 | Merger reserve | 392 |
| Other non‐current assets | 199 | ||
| Total shareholders' | |||
| Total non‐current assets | 202 | equity | 392 |
| Current assets | Current liabilities | ||
| Other receivables | 49 | Trade payables | 175 |
| Provisions for risks and | |||
| Other current assets | 13 | charges | 176 |
| Cash and cash equivalents | 479 | ||
| Total current assets | 541 | Total current liabilities | 351 |
| Total shareholders' | |||
| Total assets | 743 | equity and liabilities | 743 |
The remaining 1% of Recordati Rare Diseases Italy was acquired during the first nine months of 2021 for € 0.3 million. Furthermore, with the aim of extending the rare diseases sector into new markets, a Chinese company Recordati (Beijing) Pharmaceutical Co. Ltd, was established. Finally, the Austrian subsidiary Pro Farma GmbH was renamed Recordati Austria GmbH.
These financial statements are presented in euro (€), rounded to thousands of euro, except where indicated otherwise.
These interim consolidated financial statements were prepared in accordance with the recognition and measurement criteria prescribed by the International Financial Reporting Standards (IFRS) adopted by the European Union, but do not include the full information required for the annual financial statements and must therefore be read together with the annual report for the full year ended 31 December 2020, prepared in accordance with the IFRSs issued by the International Accounting Standards Board (IASB) and endorsed by the European Union pursuant of regulation no. 1606/2002.
The preparation of the interim financial statements requires management to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements. If in the future, these estimates and assumptions, which are based on management's best judgement, should deviate from the actual circumstances, these will be modified in relation to the circumstances. In making the estimates and assumptions related to the preparation of these interim financial statements, the impacts, even potential ones, deriving from the COVID‐19 pandemic were taken into account. Valuation exercises, in particular complex calculations such as those required to identify impairment loss, are carried out in depth only for the preparation of the year‐end consolidated financial statements, except when there are impairment loss indicators, which would require an immediate estimate of the loss.
In relation to financial instruments measured at fair value, IFRS 13 requires the classification of these instruments according to the standard's hierarchy levels, which reflect the significance of the inputs used in establishing the fair value. The following levels are used:
Disclosure of the net financial position is included in the section "Management Review" of this Report.
The accounting policies applied in these interim financial statements are the same as those applied in the last annual financial statements.
The Group's operations and main revenue streams are those described in the last annual financial statements. The Group's revenue derives from contracts with customers and is not subject to seasonal fluctuations.
In the first nine months of 2021, net revenue amounted to € 1,156.2 million (€ 1,093.8 million in the same period in 2020) and can be broken down as follows:
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
|---|---|---|---|
| Net sales | 1,117,605 | 1,064,960 | 52,645 |
| Royalties | 4,045 | 4,141 | (96) |
| Upfront payments | 4,050 | 3,521 | 529 |
| Various revenue | 30,489 | 21,196 | 9,293 |
| Total net revenue | 1,156,189 | 1,093,818 | 62,371 |
Revenue for up‐front payments is related to the activity of licensing and distribution of products in the portfolio and is recognized when it accrues along the time horizon of collaboration with customers. Revenue for € 4.1 million recorded in the first nine months of 2021 refers mainly to marketing agreements for pitavastatin (€ 1.1 million), for the lercanidipine+enalpril combination (€ 0.8 million), lercanidipine (€ 0.7 million, Cystadrops® (cysteamine hydrochloride) (€ 0.6 million), and for silodosin (€ 0.3 million). The remaining balance of amounts already paid up front by customers, which will be recognized as revenue in future periods, recorded under other current liabilities (see Note 21), was € 7.6 million (€ 10.3 million at 31 December 2020).
"Various revenue" includes € 26.1 million, corresponding to the sales margin for Eligard® — a medicinal product for the treatment of prostate cancer — earned by Astellas Pharma Europe Ltd, as the previous licensee, and retroceded to Recordati following the contract finalized in January 2021 between Tolmar International Ltd. and Recordati S.p.A. for the assignment of the new product license. The first nine months of 2020 included € 19.5 million under this item, relating to the margin on sales of Signifor® and Signifor® LAR® realized by Novartis AG on behalf of Recordati following the transfer of the rights on these products. Subsequent to the transfer of the Marketing Authorization, initially in the United States of America and then gradually also for Europe and other geographic areas, the recognition of the margin on the sales of Signifor® and Signifor® LAR® was progressively replaced by direct sales, which currently represent almost the entire revenue amount.
In the tables below, net revenue is disaggregated by product or product class and by geographic area by country. The tables also include a reconciliation of the disaggregated revenue with the Group's reportable segments.
| € (thousands) | Specialty and Primary Care |
Specialty and Primary Care |
Rare diseases |
Rare diseases |
Total | Total |
|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | |
| Zanidip® | 107,193 | 106,083 | ‐ | ‐ | 107,193 | 106,083 |
| Zanipress® | 31,307 | 38,234 | ‐ | ‐ | 31,307 | 38,234 |
| Urorec® | 45,265 | 58,488 | ‐ | ‐ | 45,265 | 58,488 |
| Livazo® | 31,849 | 42,450 | ‐ | ‐ | 31,849 | 42,450 |
| Seloken®/Logimax® | 72,991 | 77,699 | ‐ | ‐ | 72,991 | 77,699 |
| Eligard® | 59,362 | ‐ | ‐ | ‐ | 59,362 | ‐ |
| Other corporate | ||||||
| products | 118,713 | 120,303 | ‐ | ‐ | 118,713 | 120,303 |
| Drugs for rare diseases | 279,386 | 232,359 | 279,386 | 232,359 | ||
| OTC | 200,133 | 198,608 | ‐ | ‐ | 200,133 | 198,608 |
| Local product | ||||||
| portfolios | 166,146 | 174,345 | ‐ | ‐ | 166,146 | 174,345 |
| Other revenue | 8,413 | 7,317 | ‐ | ‐ | 8,413 | 7,317 |
| Pharmaceutical | ||||||
| chemicals | 35,431 | 37,932 | ‐ | ‐ | 35,431 | 37,932 |
| Total net revenue | 876,803 | 861,459 | 279,386 | 232,359 | 1,156,189 | 1,093,818 |
| € (thousands) | Specialty and | Specialty and | Rare | Rare | Total | Total |
|---|---|---|---|---|---|---|
| Primary Care | Primary Care | diseases | diseases | |||
| 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | |
| Net pharmaceutical revenue | ||||||
| Italy | 181,196 | 188,750 | 14,621 | 14,148 | 195,817 | 202,898 |
| France | 87,609 | 86,235 | 24,595 | 22,897 | 112,204 | 109,132 |
| Russia, Ukraine, other CIS | 59,752 | 66,719 | 3,695 | 2,370 | 63,447 | 69,089 |
| Germany | 96,708 | 87,495 | 15,019 | 13,100 | 111,727 | 100,595 |
| Spain | 75,807 | 54,414 | 10,048 | 8,665 | 85,855 | 63,079 |
| Turkey | 49,224 | 59,252 | 4,284 | 3,191 | 53,508 | 62,443 |
| Portugal | 32,050 | 31,313 | 1,430 | 1,244 | 33,480 | 32,557 |
| Other Eastern European | ||||||
| countries | 73,511 | 62,018 | 6,770 | 5,080 | 80,281 | 67,098 |
| Other Western European | ||||||
| countries | 54,627 | 46,268 | 21,244 | 20,596 | 75,871 | 66,864 |
| North Africa | 25,902 | 31,753 | 1,431 | 1,619 | 27,333 | 33,372 |
| Other international sales | 104,986 | 109,310 | 48,740 | 50,031 | 153,726 | 159,341 |
| U.S.A. | ‐ | ‐ | 127,509 | 89,418 | 127,509 | 89,418 |
| Total net pharmaceutical | ||||||
| revenue | 841,372 | 823,527 | 279,386 | 232,359 | 1,120,758 | 1,055,886 |
| Net pharmaceutical chemicals revenue |
||||||
| Italy | 4,031 | 3,302 | ‐ | ‐ | 4,031 | 3,302 |
| Other European countries | 13,119 | 11,749 | ‐ | ‐ | 13,119 | 11,749 |
| U.S.A. | 4,031 | 4,225 | ‐ | ‐ | 4,031 | 4,225 |
| America (U.S.A. excluded) | 3,104 | 3,692 | ‐ | ‐ | 3,104 | 3,692 |
| Australasia | 9,732 | 13,844 | ‐ | ‐ | 9,732 | 13,844 |
| Africa | 1,414 | 1,120 | ‐ | ‐ | 1,414 | 1,120 |
| Total net pharmaceutical | ||||||
| chemicals revenue | 35,431 | 37,932 | 0 | 0 | 35,431 | 37,932 |
| Total net revenue | 876,803 | 861,459 | 279,386 | 232,359 | 1,156,189 | 1,093,818 |
Total operating expenses for the first nine months of 2021 amounted to € 783.3 million, up compared to the € 729.8 million for the corresponding period the previous year, and are classified by function as follows:
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
|---|---|---|---|
| Cost of sales | 313,005 | 308,237 | 4,768 |
| Selling expenses | 287,007 | 256,701 | 30,306 |
| Research and development expenses | 119,691 | 106,344 | 13,347 |
| General and administrative expenses | 60,057 | 53,644 | 6,413 |
| Other (income)/expenses, net | 3,502 | 4,855 | (1,353) |
| Total operating expenses | 783,262 | 729,781 | 53,481 |
The cost of sales was € 313.0 million, slightly up compared to the first nine months of 2020. The impact on revenue was 27.1%, lower than the 28.2% in the first nine months of 2020 due to the positive effect from the increased portion of turnover in products for the treatment of rare diseases.
Selling expenses increased by 11.8% compared to the first nine months of 2020, mainly due to the royalties paid to Tolmar International Ltd. for the new product Eligard® as well as the administrative charges payable to Astellas for the countries where Recordati's authorization to sell Eligard® has not yet been transferred. Marketing expenses also increased, mainly due to the launch of Isturisa®.
Research and development expenses were at € 119.7 million, increasing by 12.6% over the first nine months of last year, mainly due to the investments to support endocrinology products and increased amortizations on the rights for Isturisa®, launched in the second quarter of 2020, and for Eligard®, acquired under license from Tolmar International in January 2021.
General and administrative expenses increased by 12.0% to strengthen the general coordination structure to support an increasingly complex portfolio and specifically to support the management of Signifor®, Isturisa® and Eligard® products, which are expected to record sustained growth in 2021 and into the future.
The following table summarizes the more significant components of "Other net (income)/expenses".
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
|---|---|---|---|
| Non‐recurring costs for the COVID‐19 epidemic | 1,822 | 5,182 | (3,360) |
| Other | 1,680 | (327) | 2,007 |
| Other (income)/expenses, net | 3,502 | 4,855 | (1,353) |
The costs incurred for the COVID‐19 epidemic are for donations in favour of hospitals and national health services, making work environments safe and the purchase of personal protective equipment.
Total operating expenses are analyzed by nature as follows:
| € (thousands) | First nine months 2021 |
First nine months 2020 |
Change 2021/2020 |
|---|---|---|---|
| Material consumption | 238,038 | 231,297 | 6,741 |
| Payroll costs | 201,494 | 185,963 | 15,531 |
| Other employee costs | 21,624 | 21,618 | 6 |
| Variable sales expenses | 80,488 | 61,767 | 18,721 |
| Depreciation and amortization | 72,896 | 69,582 | 3,314 |
| Utilities and consumables | 27,181 | 26,528 | 653 |
| Other expenses | 141,541 | 133,026 | 8,515 |
| Total operating expenses | 783,262 | 729,781 | 53,481 |
The proportion of raw material consumption to net revenue was 20.6%, down compared to the 21.1% of the same period in 2020.
The item "Payroll costs" includes stock option plan expenses totalling € 3.6 million, in line with the same period the previous year.
As from 2019, some Group employees were designated as beneficiaries of an incentive plan, with a 5‐year vesting period, under which they acquired, at nominal value, shares of Rossini Luxembourg S.à r.l., an indirect shareholder of Recordati S.p.A., and will benefit from a return at the expiry of the plan term. Recognition according to the IFRS 2 accounting standard at 30 September 2021 determined an expense in the income statement of € 0.8 million.
Amortization items equalled € 72.9 million, of which, € 54.0 million related to intangible assets, increasing by € 3.4 million over the same period the previous year, due mainly to the launch of Isturisa® in the second quarter of 2020, the license contract with Tolmar International for Eligard® in January 2021, and € 18.9 million relating to property, plant and equipment, down by € 0.1 million on the first nine months of 2020.
In the first nine months of 2021 and same period in 2020, the balance of financing items was negative for € 22.2 million and € 11.2 million, respectively. The main balance items are summarized in the table below.
| € (thousands) | First nine months | First nine months | Change |
|---|---|---|---|
| 2021 | 2020 | 2021/2020 | |
| Interest expense on loans | 12,605 | 12,188 | 417 |
| Net exchange rate (gains)/losses | 6,753 | (600) | 7,353 |
| Net (income)/expense on short‐term positions | 2,211 | (1,282) | 3,493 |
| Expenses on leases | 591 | 828 | (237) |
| Expenses for defined benefit plans | 31 | 58 | (27) |
| Total net financial (income)/expenses | 22,191 | 11,192 | 10,999 |
Exchange losses were mainly determined by transactions in Russian roubles and U.S. dollars, currencies which were revalued against the euro compared to the end of 2020.
The change to "Net (income)/expense on short‐term positions" is mainly attributable to the recognition in the first nine months of 2020 of the positive effects of the repayment of the two intercompany loans and relative cross‐currency swaps for € 2.6 million.
Income taxes, at € 54.4 million, include income taxes levied on all consolidated companies as well as the regional tax on production (IRAP) which is levied on all companies domiciled in Italy, and decreased by € 24.4 million compared to the first nine months of 2020, mainly following the recognition of non‐recurring tax benefits for € 26.2 million.
After the merger of Recordati Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. was finalized in April, Recordati S.p.A. inherited the ACE base and the ACE surplus of Rossini Investimenti S.p.A., with a non‐ recurring positive tax effect in 2021 of € 12.9 million and a recurring tax benefit of approximately € 1.2 million per year. ACE (Allowance for Corporate Equity) is tax relief for companies governed by Art. 1 of Italian Decree Law no. 201/2011 and by Italian Ministerial Decree 3/8/2017, and consists of the taxation of part of the taxable income proportional to the increases in equity. The merger also extinguished group taxation between Recordati S.p.A. and FIMEI S.p.A., and established that tax consolidation will continue between Recordati S.p.A. (as the consolidating company) and Italchimici S.p.A.
Following the approval of the 2020 year‐end consolidated financial statements, the Italian subsidiary Natural Point S.r.l. revalued its self‐generated figurative mark for Magnesio Supremo®, in application of Article 110 of Italian Decree Law no. 104 of 10 August 2020, converted with amendments by Law no. 126 of 13 October 2020. The subsidiary used the market value criterion to identify the maximum amount for the brand revaluation, which was determined on the basis of an independent expert's report. In the subsidiary's financial statements at 31 December 2020, the brand was consequently revalued to € 53.6 million, which was lower than the maximum limit identified in the expert's report, and aligns to the net carrying amount recognized in the Recordati Group's consolidated financial statements. As permitted by the aforementioned legislation, the revalued amount in the subsidiary's financial statements was effective for tax purposes as from 1 January 2021, with the payment of substitute tax for € 1.6 million, equalling 3% of the revalued amount.
The higher value for the brand for € 61.2 million (which following amortizations, became € 53.6 million at 31 December 2020) had already been identified in the consolidated financial statements when allocating the surplus on the price paid in June 2018 to acquire the subsidiary, in relation to its carrying amount, and considering that this higher value did not have tax relevance, the corresponding deferred tax liabilities were recognized at that time. The tax applicability of the revaluation by Natural Point S.r.l., which was confirmed in the Circulars issued by the Tax Revenue Agency during 2021, resulted in the alignment of the tax and accounting values, with the consequent release of the residual amount on the deferred tax liabilities recognized in the consolidated financial statements at 31 December 2020 for € 14.9 million. Taking into account the substitute tax for € 1.6 million, the net positive effect for the Group, amounting to € 13.3 million, was recognized in the income statement to reduce the income tax.
Following the advance agreement signed with the Advance Agreement and Disputes Office of the Italian Tax Authorities on 19 December 2019, which allows the Parent Company to benefit from a discount on taxable income connected with the direct use of intangible assets for the tax years 2015 to 2019, as from 2020, the Parent Company opted to subscribe (instead of renewing the agreement) to the new optional reverse charge mechanism provided for by Art. 4 of Italian Legislative Decree no. 34 of 30 April 2019 and therefore directly determine the discount on taxable income provided by the "Patent Box" for the current year, using the same criteria already agreed with the Tax Authorities and providing documentation supporting the calculation. The relevant benefit for the first nine months of 2021, totalling € 6.2 million, was recognized to reduce the tax amount.
The composition and change to property, plant and equipment, including the valuation of the right to use the assets conveyed under leases, are shown in the table below.
| € (thousands) | Land and buildings |
Plant and machinery |
Other equipment |
Investments in progress |
Total |
|---|---|---|---|---|---|
| Cost | |||||
| Balance at 31 December 2020 | 90,930 | 241,577 | 98,712 | 21,817 | 453,036 |
| Additions | 1,522 | 2,481 | 4,695 | 11,640 | 20,338 |
| Disposals | (1,086) | (1,914) | (3,803) | (135) | (6,938) |
| Other changes | (155) | 4,484 | 742 | (6,961) | (1,890) |
| Balance at 30 September 2021 | 91,211 | 246,628 | 100,346 | 26,361 | 464,546 |
| Accumulated amortization | |||||
| Balance at 31 December 2020 | 51,670 | 200,268 | 67,848 | 0 | 319,786 |
| Amortization for the period | 4,470 | 6,228 | 8,240 | 0 | 18,928 |
| Disposals | (1,017) | (1,904) | (3,759) | 0 | (6,680) |
| Other changes | (26) | (435) | (19) | 0 | (480) |
| Balance at 30 September 2021 | 55,087 | 204,157 | 72,310 | 0 | 331,554 |
| Net amount | |||||
| 31 December 2020 | 39,260 | 41,309 | 30,864 | 21,817 | 133,250 |
| 30 September 2021 | 36,124 | 42,471 | 28,036 | 26,361 | 132,992 |
Increases over the period, totalling € 20.3 million, refer mainly to the Parent Company (€ 13.5 million) and the subsidiaries Recordati Pharma GmbH (€ 0.8 million), Recordati Ireland (€ 0.7 million), Recordati Polska (€ 0.7 million) and Opalia Pharma (€ 0.7 million).
"Other changes" includes the conversion into euro of the property, plant and equipment recognized in different currencies, for a net decrease of € 1.4 million compared to 31 December 2020, primarily due to the devaluation of the Turkish lira.
The following table shows the measurement of the right to use the assets conveyed under leases, determined as prescribed by the accounting standard IFRS 16.
| € (thousands) | Land and Buildings |
Plant and machinery |
Other equipment |
Total |
|---|---|---|---|---|
| Cost | ||||
| Balance at 31 December 2020 | 20,619 | 1,082 | 19,861 | 41,562 |
| Additions | 1,215 | 353 | 3,495 | 5,063 |
| Disposals | (1,086) | (5) | (3,088) | (4,179) |
| Other changes | 136 | 0 | (198) | (62) |
| Balance at 30 September 2021 | 20,884 | 1,430 | 20,070 | 42,384 |
| Accumulated amortization | ||||
| Balance at 31 December 2020 | 6,684 | 188 | 8,255 | 15,127 |
| Amortization for the period | 2,816 | 162 | 4,486 | 7,464 |
| Disposals | (1,017) | (5) | (3,053) | (4,075) |
| Other changes | 29 | 0 | (103) | (74) |
| Balance at 30 September 2021 | 8,512 | 345 | 9,585 | 18,442 |
| Net amount | ||||
| 31 December 2020 | 13,935 | 894 | 11,606 | 26,435 |
| 30 September 2021 | 12,372 | 1,085 | 10,485 | 23,942 |
Rights of use of leased assets refer mainly to the office premises of several Group companies and to the cars used by medical representatives operating in their territories.
The composition and change in intangible assets are shown in the following table.
| € (thousands) | Patent rights and marketing authorizations |
Distribution, license, trademark and similar rights |
Other | Advance payments |
Total |
|---|---|---|---|---|---|
| Cost | |||||
| Balance at 31 December 2020 | 1,029,335 | 504,149 | 20,651 | 48,436 | 1,602,571 |
| Additions | 574 | 50,287 | 278 | 10,136 | 61,275 |
| Disposals | (1) | (17) | (3) | 0 | (21) |
| Other changes | 5,946 | 3,072 | 226 | (785) | 8,459 |
| Balance at 30 September | |||||
| 2021 | 1,035,854 | 557,491 | 21,152 | 57,787 | 1,672,284 |
| Accumulated amortization | |||||
| Balance at 31 December 2020 | 253,685 | 214,572 | 18,503 | 0 | 486,760 |
| Amortization for the period | 34,512 | 19,041 | 415 | 0 | 53,968 |
| Disposals | (1) | (17) | (3) | 0 | (21) |
| Other changes | 3,153 | 423 | (35) | 0 | 3,541 |
| Balance at 30 September | |||||
| 2021 | 291,349 | 234,019 | 18,880 | 0 | 544,248 |
| Net amount | |||||
| 31 December 2020 | 775,650 | 289,577 | 2,148 | 48,436 | 1,115,811 |
| 30 September 2021 | 744,505 | 323,472 | 2,272 | 57,787 | 1,128,036 |
Increases for the period include:
"Other changes" includes the conversion into euro of the value of the intangible assets held and recognized in different currencies, which was a net increase of € 4.8 million compared to 31 December 2020, mainly attributable to the revaluation of the U.S. dollar for € 3.8 million and the Russian rouble for € 1.1 million.
Net goodwill at 30 September 2021 amounted to € 560.3 million, a decrease of € 1.8 million compared to 31 December 2020, and is attributed to the operational areas, which represent the same number of cash generating units:
Goodwill related to acquisitions made in countries outside the European Monetary Union is calculated in local currency and converted into euro at the period‐end exchange rate. Compared to 31 December 2020, this determined a total net decrease of € 1.8 million attributable to the acquisitions made in Turkey (decrease of € 3.1 million), Poland (decrease of € 0.2 million), Tunisia (increase of € 0.1 million), Czech Republic (increase of € 0.4 million) and Russia (increase of € 1.0 million).
In compliance with IFRS 3 goodwill is not systematically amortized. Instead, it is tested for impairment on an annual basis or more frequently if specific events or circumstances indicate a possible loss of value. During the period no events or circumstances arose to indicate possible value loss related to any of the above‐ mentioned items.
At 30 September 2021, these amounted to € 42.0 million, down by € 3.6 million compared to 31 December 2020.
The main investment refers to the U.K. company PureTech Health plc, specializing in investments in start‐up companies dedicated to innovative therapies, medical devices and new research technologies. Starting from 19 June 2015, the shares of the Company were admitted for trading on the London Stock Exchange. At 30 September 2021, the total fair value of the 9,554,140 shares held was € 39.7 million. The value of the investment was consequently adjusted to the stock exchange value and fell by € 2.8 million, compared to 31 December 2020, with a counter‐item accounted for, net of the related tax effect, in the statement of gains and losses recognized in shareholders' equity.
This item also includes € 2.2 million regarding an investment made during 2012 in Erytech Pharma S.A., a listed French biopharmaceutical company, focused on developing new therapies for rare oncological pathologies and orphan diseases. The investment, originally structured as a non‐interest‐bearing loan, was converted into 431,034 company shares in May 2013. The value of the investment was adjusted to the stock exchange value and decreased by € 0.9 million, compared to 31 December 2020, with a counter‐item accounted for, net of the related tax effect, in the statement of gains and losses recognized in shareholders' equity.
At 30 September 2021, this item came to € 31.9 million, up by € 25.1 million compared to 31 December 2020. The increase is primarily attributable to the recognition of assets for the subsidiary Recordati AG in the scope of the contract agreements with Novartis AG referring to the acquisition of rights on the Signifor® and Signifor® LAR products.
At 30 September 2021, deferred tax assets amounted to € 76.2 million, recording a net increase of € 1.1 million compared to 31 December 2020.
Inventories amounted to € 244.5 million, down by € 6.8 million compared to 31 December 2020.
Trade receivables amounted to € 300.8 million at 30 September 2021, up by € 31.9 million compared to 31 December 2020. The balance is less the provision for € 15.0 million, in line with 31 December 2020, recognized under selling expenses, which reflects the collection risk connected with certain customers and geographic areas. Average days sales outstanding are 67.
Other receivables amounted to € 44.9 million, down by € 2.4 million compared to 31 December 2020.
Other current assets were at € 15.0 million and refer mainly to prepaid expenses.
The measurement at market (fair value) of cross currency swaps entered into by the Parent Company to hedge the US\$ 75 million loan issued on 30 September 2014 gave rise to a € 9.7 million asset at 30 September 2021. This amount represents the potential benefit of a lower value in euro of the future dollar denominated principal and interest flows, in view of the revaluation of the foreign currency with respect to the moment in which the loan and hedging instruments were negotiated. In particular, the change in fair value of the
derivative hedging the US\$ 50 million tranche of the loan, provided by Mediobanca, was positive for € 6.5 million, and that hedging the US\$ 25 million tranche of the loan, provided by UniCredit, yielded a € 3.2 million positive change.
At 30 September 2021, other hedging transactions were in place on foreign currency positions, the measurement of which was positive for a total of € 1.3 million, recognized to the income statement and offsetting the exchange losses arising from the valuation of the underlying positions at current exchange rates.
The fair value of these hedging derivatives is measured at level 2 of the hierarchy provided for in the IFRS 13 accounting standard. The fair value is equal to the current value of the estimated future cash flows. Estimates of future floating‐rate cash flows are based on quoted swap rates futures prices and interbank borrowing rates. Estimated cash flows are discounted using a yield curve which reflects the relevant benchmark interbank rate used by market participants for pricing interest rate swaps.
At 30 September 2021, the balance of this item amounted to € 341.9 million, increasing by € 153.7 million on 31 December 2020, and are mainly denominated in euro, US dollars, pounds sterling and comprise current account deposits and short‐term time deposits.
Shareholders' Equity at 30 September 2021 was € 1,445.1 million, an increase of € 168.8 million compared to 31 December 2020 due to the combined effect of the following reasons:
The remaining 1% of the share capital in the Italian subsidiary Recordati Rare Diseases Italy was acquired in July, bringing the shareholding to 100%. Consequently, the portion of shareholders' equity is no longer recognized under non‐controlling interests.
At 30 September 2021, the Company has three existing stock option plans in favour of certain Group employees: the 2014‐2018 plan with the grant of 29 July 2014 and 13 April 2016 and the 2018‐2022 plan, with the grant of 3 August 2018, and the 2021‐2023 plan with the grant of 6 May 2021. The strike price for the options is the average of the Parent Company's listed share price during the 30 days prior to the grant
date. The options are vested over a period of five years, over four tranches, starting from the second year in the case of the less recent grants, and three years for the 2021 grant, payable in a single tranche. They expire if they are not exercised within the eighth year after the grant date. Options cannot be exercised if the employee leaves the Company before they are vested.
| Total | 6,207,000 | 3,219,500 | (1,569,000) | (89,500) | 7,768,000 | |
|---|---|---|---|---|---|---|
| 6 May 2021 | 45.97 | ‐ | 3,219,500 | ‐ | ‐ | 3,219,500 |
| 3 August 2018 | 30.73 | 3,841,000 | ‐ | (712,500) | (85,000) | 3,043,500 |
| 13 April 2016 | 21.93 | 1,587,500 | ‐ | (564,500) | (4,500) | 1,018,500 |
| 29 July 2014 | 12.29 | 778,500 | ‐ | (292,000) | ‐ | 486,500 |
| Grant date | ||||||
| Strike price (€) |
Quantity 1/1/2021 |
Granted 2021 |
Exercised in 2021 |
Cancelled and expired 2021 |
Quantity 30.9.2021 |
Stock options outstanding at 30 September 2021 are detailed in the following table:
At 30 September2021, 2,760,302 treasury shares were held in the portfolio, a decrease of 69,000 shares compared to 31 December 2020. The change was due to the disposal of 1,569,000 shares for an amount of € 37.9 million to enable the options attributed to employees as part of the stock option plans to be exercised and to the purchase of 1,500,000 shares for an amount of € 66.9 million. The total cost to purchase the treasury shares in the portfolio was € 98.9 million, with an average unit price of € 35.84.
As from 2019, some Group employees were designated as beneficiaries of an incentive plan, with a 5‐year vesting period, under which they acquired, at nominal value, shares of Rossini Luxembourg S.à r.l., an indirect shareholder of Recordati S.p.A., and will benefit from a return at the expiry of the plan term.
At 30 September 2021, loans amounted to € 1,052.9 million, increasing by a net € 4.4 million compared to 31 December 2020.
This item includes the liabilities deriving from the application of the IFRS 16 accounting standard, representing the obligation to make the payments provided for in the existing leases for a total amount of € 24.2 million, a net decrease of € 2.5 million compared to 31 December 2020.
In the first nine months of 2021, new bank loans were taken out for 219.1 million and new lease contracts were signed for € 5.1 million, whereas a total of € 223.6 million was repaid, of which € 7.2 million related to lease liabilities. The € 25.0 million loan from Banca Nazionale del Lavoro was repaid on the expiry of the contract in March, with the payment of the last instalment of € 6.3 million. In September, the loan for € 50.0 million undertaken in 2017 with UniCredit was extinguished with a single repayment. With the aim of improving the management of its overall debt, the Parent Company repaid three loans in advance of their natural maturity.
Specifically:
The effect of the translation of loans in foreign currencies and of expenses incurred to place the loans, together with the early termination of a number of leases, determined a total net increase of € 3.8 million compared to 31 December 2020.
The main loans outstanding are:
These parameters are being observed.
These parameters are being observed.
c) Loan for 75.0 million Swiss francs taken out on 17 April 2020 by the subsidiary Recordati AG with UBS Switzerland AG, at a variable interest rate of the 3‐months Libor on the Swiss currency (with a zero floor) plus a fixed spread, with quarterly interest payments and semi‐annual repayment of principal starting September 2020 through March 2025. The value in euro of the outstanding loan at 30 September 2021 was € 48.5 million.
The loan, guaranteed by the Parent Company, includes covenants which, if not observed, could lead to a request for immediate repayment.
The financial covenants, measured semi‐annually, are the following:
These parameters are being observed.
d) Loan for € 400.0 million negotiated by the Parent Company in June 2019 aimed at supporting the Group's growth strategy. The loan, initially agreed with Mediobanca, Natixis and Unicredit was subsequently syndicated involving a pool of Italian and international banks. The terms of the loan provide for a variable interest rate at the 6‐month Euribor (with a zero floor) plus a variable spread based on a step up/step down mechanism on changes in the Leverage Ratio, and a duration of 5 years with semi‐annual repayment of the principal starting 30 June 2020 through June 2024. The disbursement, net of upfront commissions, took place on 30 July 2019. The debt outstanding recognized at 30 September 2021 amounted to a total of € 317.3 million.
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured semi‐annually, are the following:
These parameters are being observed.
e) Loan for € 150.0 million taken out by the Parent Company in November 2018 with Mediobanca, at a variable interest rate of the 6‐month Euribor plus a variable spread based on a step up mechanism on changes in the Leverage Ratio, with quarterly interest payments and a duration of 5 years with semi‐ annual repayments of principal starting November 2020 through November 2023. The debt outstanding at 30 September 2021 amounted to € 106.8 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 September 2021, the fair value of the derivative was measured at negative € 1.3 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:
These parameters are being observed.
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:
• the ratio of consolidated net financial position to consolidated EBITDA (determined for a period of
twelve consecutive months) must be less than 3;
• the ratio of consolidated operating income to consolidated net financial expenses (determined for a period of twelve consecutive months) must be more than 3.
These parameters are being observed.
h) Loan for € 75.0 million taken out by the Parent Company in October 2017 with Intesa Sanpaolo. The main conditions provide for a variable interest rate of the 6‐month Euribor plus a fixed spread, semi‐annual interest payments and a duration of 8 years with semi‐annual repayments of principal from June 2019 through October 2025. The debt outstanding at 30 September 2021 amounted to € 48.1 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 September 2021, the fair value of the derivative was measured at negative € 0.9 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:
These parameters are being observed.
j) Loan for € 75.0 million taken out by the Parent Company in July 2017 with Mediobanca. The main conditions of the loan provide for a variable interest rate of the 6‐month Euribor plus a fixed spread and a duration of 7 years with annual repayments of principal from July 2018 through July 2024. The debt outstanding at 30 September 2021 amounted to € 33.0 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the entire debt to a fixed interest rate. At 30 September 2021, the fair value of the derivative was measured at negative € 0.5 million, which was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:
These parameters are being observed.
k) Privately placed guaranteed senior notes by the Parent Company in May 2017 for an overall amount of € 125.0 million at a fixed interest rate with repayment in annual instalments starting on 31 May 2025 through 31 May 2032.
The note purchase agreement covering the senior guaranteed notes issued by Recordati S.p.A. includes covenants which, if not met, could lead to a request for immediate repayment of the loan.
The financial covenants, measured quarterly, are the following:
These parameters are being observed.
l) Loan for € 25.0 million taken out by the Parent Company in December 2016 with Intesa Sanpaolo. The main conditions of the loan provide for a variable interest rate of the 6‐month Euribor plus a fixed spread and a duration of 5 years with semi‐annual repayments of principal from June 2019 through December 2021. The debt outstanding at 30 September 2021 amounted to € 4.2 million. The loan was hedged with an interest rate swap, qualifying as a cash flow hedge, effectively converting the debt to a fixed interest rate. At 30 September 2021, the fair value measurement of the derivative was slightly negative and was recognized directly as a decrease in equity and as an increase in the liability item "Derivative instruments measured at fair value" (see Note 22).
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured annually, are the following:
These parameters are being observed.
m) Loan disbursed on 16 October 2014 to the subsidiary Recordati Ilaç by IFC‐World Bank for 71.6 million Turkish lira to finance the construction of a new production plant. The main conditions provide for a variable interest rate of the 3‐month Trlibor plus a fixed spread and a duration of 8 years with quarterly repayments of principal from November 2016 through August 2022. The counter‐value of the outstanding debt at 30 September 2021 amounted to € 1.1 million, down by € 1.1 million compared to 31 December 2020. This reduction was determined for € 0.2 million by the depreciation of the Turkish lira against the consolidation currency.
The loan includes covenants which, if not observed, could lead to a request for immediate repayment. The financial covenants, measured quarterly, are the following:
These parameters are being observed.
n) Guaranteed senior notes issued by the Parent Company on 30 September 2014 for a total of US\$ 75 million, divided into two tranches: US\$ 50 million at fixed rate, repayable semi‐annually starting 30 March 2022 and with maturity 30 September 2026, and US\$ 25 million again at fixed rate, repayable semi‐ annually starting 30 March 2023 and with maturity 30 September 2029. The conversion of the loan at 30 September 2021 resulted in an increased liability for € 3.7 million compared to 31 December 2020, due to the revaluation of the U.S. dollar against the consolidation currency.
The loan was hedged at the same time with two cross‐currency swap operations, which provide for the conversion of the debt into a total of € 56.0 million, of which € 37.3 million at a lower fixed rate for the tranche with maturity at 12 years and € 18.7 million again at a lower fixed rate for per that with maturity at 15 years. At 30 September 2021, hedging instruments measured at fair value were positive for a total of € 9.7 million, which was recognized directly as an increase in equity and as an increase in the asset item "Derivative instruments measured at fair value" (see Note 14).
The note purchase agreement covering the senior guaranteed notes issued by Recordati S.p.A. includes covenants which, if not met, could lead to a request for immediate repayment of the loan.
The financial covenants, measured quarterly, are the following:
These parameters are being observed.
At 30 September 2021, this item amounted to € 21.4 million and reflects the Group's liability towards its employees determined in accordance with IAS 19.
At 30 September 2021, deferred tax liabilities amounted to € 27.8 million, a sharp decrease of € 13.4 million compared to 31 December 2020. The decrease is mainly attributable to the release of € 14.9 million to the income statement following the revaluation of the Magnesio Supremo® brand by the Italian company Natural Point S.r.l. (see Note 6).
At 30 September 2021, the balance for other liabilities recorded under non‐current liabilities was zero following the reclassification of future payments to Novartis AG under current liabilities, related to the marketing of Isturisa® in certain European markets.
Trade payables at € 166.9 million, included the accrual for invoices to be received.
Other liabilities amounted to € 133.1 million, increasing by € 37.4 million compared to 31 December 2020, and mainly include:
€ 9.0 million which Recordati Rare Diseases Inc. must pay to U.S. health care insurance schemes;
€ 2.1 million to be paid to the "Krankenkassen" (German health insurance schemes) by Recordati Pharma GmbH;
Tax liabilities amounted to € 40.2 million, in line with the amount at 31 December 2020.
Other current liabilities amounted to € 8.4 million, down by € 2.8 million compared to 31 December 2020. An amount of € 7.6 million is attributable to the adoption of the IFRS 15 accounting principle, based on which some deferred revenue is recognized in the income statement in variable instalments based on the fulfilment of the conditions for revenue recognition.
The provisions for risks and charges amounted to € 14.2 million, down by € 2.9 million compared to 31 December 2020.
The measurement at market (fair) value at 30 September 2021 of the interest rate swaps hedging a number of loans gave rise to a total € 3.0 million liability, which represents the unrealized opportunity of paying in the future, for the duration of the loans, the variable rates currently expected instead of the rates agreed. The amount is related to the interest rate swaps entered into by the Parent Company to hedge the interest rates on loans with Mediobanca (€ 1.8 million) and Intesa Sanpaolo (€ 1.2 million).
In October 2019, Recordati S.p.A. entered into forward exchange contracts to hedge the intercompany loan granted to Recordati AG for an amount of 228.9 million Swiss francs. The measurement of the derivative at 30 September 2021 on the outstanding loan of 182.7 million Swiss francs was a negative € 2.1 million, which was recognized in the income statement, offsetting the exchange gains determined by the valuation of the underlying loan at current exchange rates.
At 30 September 2021, other hedging transactions were in place on foreign currency positions, with the measurement negative for a total of € 1.0 million, recognized in the income statement and offsetting the exchange gains arising from the valuation of the underlying positions at current exchange rates.
The fair value of these hedging derivatives is measured at level 2 of the hierarchy provided for in the IFRS 13 accounting standard. The fair value is equal to the current value of the estimated future cash flows. Estimates of future floating‐rate cash flows are based on quoted swap rates futures prices and interbank borrowing rates. Estimated cash flows are discounted using a yield curve which reflects the relevant benchmark interbank rate used by market participants for pricing interest rate swaps.
Debts to banks and other lenders at 30 September 2021 were € 13.5 million and comprise the use of short‐ term credit lines, overdrafts and interest due on existing loans.
The financial information reported by line of business, in compliance with IFRS 8 – Operating Segments, is prepared using the same accounting principles used for the preparation and disclosure of the Group's consolidated financial statements. Two main business segments can be identified, the Specialty & Primary Care segment and the rare diseases segment.
The tables below show the figures for these segments at 30 September 2021 and include comparative data.
| € (thousands) | Specialty and Primary Care segment |
Rare diseases segment |
Values not allocated |
Consolidated financial statements |
|---|---|---|---|---|
| First nine months 2021 | ||||
| Net revenue | 876,803 | 279,386 | ‐ | 1,156,189 |
| Expenses | (611,308) | (171,954) | ‐ | (783,262) |
| Operating income | 265,495 | 107,432 | ‐ | 372,927 |
| First nine months 2020 | ||||
| Net revenue | 861,459 | 232,359 | ‐ | 1,093,818 |
| Expenses | (594,043) | (135,738) | ‐ | (729,781) |
| Operating income | 267,416 | 96,621 | ‐ | 364,037 |
| € (thousands) | Specialty and Primary Care |
Rare diseases segment |
Values not allocated* |
Consolidated financial |
|---|---|---|---|---|
| segment | statements | |||
| 30 September 2021 | ||||
| Non‐current assets | 1,182,727 | 746,740 | 41,963 | 1,971,430 |
| Inventories | 196,344 | 48,157 | ‐ | 244,501 |
| Trade receivables | 228,485 | 72,284 | ‐ | 300,769 |
| Other receivables and other current | ||||
| assets | 42,036 | 17,862 | 11,021 | 70,919 |
| Short‐term financial investments, | ||||
| cash and cash equivalents | ‐ | ‐ | 341,926 | 341,926 |
| Total assets | 1,649,592 | 885,043 | 394,910 | 2,929,545 |
| Non‐current liabilities | 43,446 | 5,692 | 824,701 | 873,839 |
| Current liabilities | 226,610 | 136,256 | 247,772 | 610,638 |
| Total liabilities | 270,056 | 141,948 | 1,072,473 | 1,484,477 |
| Net capital employed | 1,379,536 | 743,095 | ||
| 31 December 2020 | ||||
| Non‐current assets | 1,162,636 | 730,486 | 45,581 | 1,938,703 |
| Inventories | 210,089 | 41,163 | ‐ | 251,252 |
| Trade receivables | 200,601 | 68,296 | ‐ | 268,897 |
| Other receivables and other current | ||||
| assets | 48,133 | 9,403 | 7,036 | 64,572 |
| Cash and cash equivalents | ‐ | ‐ | 188,230 | 188,230 |
| Total assets | 1,621,459 | 849,348 | 240,847 | 2,711,654 |
| Non‐current liabilities | 57,621 | 21,071 | 778,238 | 856,930 |
| Current liabilities | 192,454 | 93,419 | 292,591 | 578,464 |
| Total liabilities | 250,075 | 114,490 | 1,070,829 | 1,435,394 |
| Net capital employed | 1,371,384 | 734,858 |
* Includes pharmaceutical chemical operations. ** Amounts not allocated refer to the items other equity investments and securities, cash and cash equivalents, loans, derivative instruments and short‐term debts to banks and other lenders.
The pharmaceutical chemical business is considered part of the Specialty and Primary Care segment as it is mainly engaged in the production of active ingredients for finished pharmaceutical products, both from a
strategic and organizational point of view.
The Parent Company and some subsidiaries are parties to minor legal actions and disputes, the outcomes of which are not expected to result in any liability. The potential liabilities that can currently be measured are not for significant amounts. Some license agreements require the payment of future milestones as certain conditions occur, in which case their occurrence is as yet uncertain, with the consequence that the contractually required payments, estimated at around € 161 million and referring primarily to the contracts with Tolmar International, Novartis and ARS Pharmaceuticals, are currently merely potential liabilities.
In April, the merger deed was drafted for the merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. into Recordati S.p.A. The subsequent filing with the Companies Register has finalized the transaction, with tax and accounting effects from 1 April 2021. The merger, approved by the Shareholders' Meeting on 17 December 2020, did not change the share capital of the incorporating company, nor any balancing cash payment. Furthermore, after the merger, Recordati S.p.A.'s balance sheet and earnings profile remained essentially consistent with prior to the transaction and, in particular, the merger did not alter Recordati's net financial position or, therefore, its investment capacity, or its capital allocation strategy or policy. As provided for in the draft terms of merger, Recordati S.p.A. inherited the ACE base and the ACE surplus of Rossini Investimenti S.p.A., with a non‐recurring positive tax effect in 2021 of € 12.9 million and a recurring tax benefit of approximately € 1.2 million per year. ACE (Allowance for Corporate Equity) is tax relief for companies governed by Art. 1 of Italian Decree Law no. 201/2011 and by Italian Ministerial Decree 3/8/2017, and consists of the taxation of part of the taxable income proportional to the increases in equity. The merger also extinguished group taxation between Recordati S.p.A. and FIMEI S.p.A., and established that tax consolidation will continue between Recordati S.p.A. (as the consolidating company) and Italchimici S.p.A. Following the transaction, the Group's immediate parent is Rossini S.à r.l., with headquarters in Luxembourg, which is owned by a consortium of investment funds controlled by CVC Capital Partners.
To our knowledge, no transactions or contracts have been entered into with related parties that can be considered significant in terms of value or conditions, or which could in any way materially affect the accounts.
At the date of preparation of the financial statements, no significant events had occurred subsequent to the close of the period that would require changes to the values of assets, liabilities or the income statement. The market context is gradually improving with the easing of the restrictions introduced to counter the COVID‐19 epidemic.
| Consolidated companies | Head office | Share capital | Currency | Consolidation method |
|---|---|---|---|---|
| RECORDATI S.p.A. Development, production, marketing and sales of pharmaceuticals and pharmaceutical chemicals |
Italy | 26,140,644.50 | EUR | Line‐by‐line |
| INNOVA PHARMA S.p.A. Marketing of pharmaceuticals |
Italy | 1,920,000.00 | EUR | Line‐by‐line |
| CASEN RECORDATI S.L. Development, production, and sales of pharmaceuticals |
Spain | 238,966,000.00 | EUR | Line‐by‐line |
| BOUCHARA RECORDATI S.A.S. Development, production, and sales of pharmaceuticals |
France | 4,600,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES COMERCIO DE MEDICAMENTOS LTDA Holds pharmaceutical marketing rights in Brazil |
Brazil | 166.00 | BRL | Line‐by‐line |
| RECORDATI RARE DISEASES INC. Development, production, and sales of pharmaceuticals |
U.S.A. | 11,979,138.00 | USD | Line‐by‐line |
| RECORDATI IRELAND LTD Development, production, and sales of pharmaceuticals |
Ireland | 200,000.00 | EUR | Line‐by‐line |
| LABORATOIRES BOUCHARA RECORDATI S.A.S. Development, production, and sales of pharmaceuticals |
France | 14,000,000.00 | EUR | Line‐by‐line |
| RECORDATI PHARMA GmbH Marketing of pharmaceuticals |
Germany | 600,000.00 | EUR | Line‐by‐line |
| RECORDATI PHARMACEUTICALS LTD Marketing of pharmaceuticals |
United Kingdom | 15,000,000.00 | GBP | Line‐by‐line |
| RECORDATI HELLAS PHARMACEUTICALS S.A. Marketing of pharmaceuticals |
Greece | 10,050,000.00 | EUR | Line‐by‐line |
| JABA RECORDATI S.A. Marketing of pharmaceuticals |
Portugal | 2,000,000.00 | EUR | Line‐by‐line |
| JABAFARMA PRODUTOS FARMACÊUTICOS S.A. Promotion of pharmaceuticals |
Portugal | 50,000.00 | EUR | Line‐by‐line |
| BONAFARMA PRODUTOS FARMACÊUTICOS S.A. Promotion of pharmaceuticals |
Portugal | 50,000.00 | EUR | Line‐by‐line |
| RECORDATI ORPHAN DRUGS S.A.S. Holding company |
France | 57,000,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES MIDDLE EAST FZ LLC Marketing of pharmaceuticals |
United Arab Emirates |
100,000.00 | AED | Line‐by‐line |
| RECORDATI AB Marketing of pharmaceuticals |
Sweden | 100,000.00 | SEK | Line‐by‐line |
| RECORDATI RARE DISEASES S.à r.l. Development, production, and sales of pharmaceuticals |
France | 320,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES UK Limited Marketing of pharmaceuticals |
United Kingdom | 50,000.00 | GBP | Line‐by‐line |
| RECORDATI RARE DISEASES GERMANY GmbH Marketing of pharmaceuticals |
Germany | 25,600.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES SPAIN S.L. Marketing of pharmaceuticals |
Spain | 1,775,065.49 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES ITALY S.R.L. Marketing of pharmaceuticals |
Italy | 40,000.00 | EUR | Line‐by‐line |
| RECORDATI BV Marketing of pharmaceuticals |
Belgium | 18,600.00 | EUR | Line‐by‐line |
| FIC MEDICAL S.à r.l. Promotion of pharmaceuticals |
France | 173,700.00 | EUR | Line‐by‐line |
| HERBACOS RECORDATI s.r.o. Development, production, and sales of pharmaceuticals |
Czech Republic | 25,600,000.00 | CZK | Line‐by‐line |
| RECORDATI SK s.r.o. Marketing of pharmaceuticals |
Slovak Republic | 33,193.92 | EUR | Line‐by‐line |
| Consolidated companies | Head office | Share capital | Currency | Consolidation method |
|---|---|---|---|---|
| RUSFIC LLC Development, promotion, and sales of pharmaceutical products |
Russian Federation | 3,560,000.00 | RUB | Line‐by‐line |
| RECOFARMA ILAÇ Ve Hammaddeleri Sanayi Ve Ticaret L.Ş. Promotion of pharmaceutical products |
Turkey | 10,000.00 | TRY | Line‐by‐line |
| RECORDATI ROMÂNIA S.R.L. Marketing of pharmaceuticals |
Romania | 5,000,000.00 | RON | Line‐by‐line |
| RECORDATI İLAÇ Sanayi Ve Ticaret A.Ş. Development, production, and sales of pharmaceuticals |
Turkey | 180,000,000.00 | TRY | Line‐by‐line |
| RECORDATI POLSKA Sp. z o.o. Marketing of pharmaceuticals |
Poland | 4,500,000.00 | PLN | Line‐by‐line |
| ACCENT LLC Holds pharmaceutical marketing rights |
Russian Federation | 20,000.00 | RUB | Line‐by‐line |
| RECORDATI UKRAINE LLC Marketing of pharmaceuticals |
Ukraine | 1,031,896.30 | UAH | Line‐by‐line |
| CASEN RECORDATI PORTUGAL Unipessoal Lda Marketing of pharmaceuticals |
Portugal | 100,000.00 | EUR | Line‐by‐line |
| OPALIA PHARMA S.A. Development, production, and sales of pharmaceuticals |
Tunisia | 9,656,000.00 | TND | Line‐by‐line |
| OPALIA RECORDATI S.à r.l. Promotion of pharmaceuticals |
Tunisia | 20,000.00 | TND | Line‐by‐line |
| RECORDATI RARE DISEASES S.A. DE C.V. Marketing of pharmaceuticals |
Mexico | 16,250,000.00 | MXN | Line‐by‐line |
| RECORDATI RARE DISEASES COLOMBIA S.A.S. Marketing of pharmaceuticals |
Colombia | 150,000,000.00 | COP | Line‐by‐line |
| ITALCHIMICI S.p.A. Marketing of pharmaceuticals |
Italy | 7,646,000.00 | EUR | Line‐by‐line |
| RECORDATI AG Marketing of pharmaceuticals |
Switzerland | 15,000,000.00 | CHF | Line‐by‐line |
| RECORDATI AUSTRIA GmbH Marketing of pharmaceuticals |
Austria | 35,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES CANADA Inc. Marketing of pharmaceuticals |
Canada | 350,000.00 | CAD | Line‐by‐line |
| RECORDATI RARE DISEASES JAPAN K.K. Marketing of pharmaceuticals |
Japan | 10,000,000.00 | JPY | Line‐by‐line |
| NATURAL POINT S.r.l. Marketing of pharmaceuticals |
Italy | 10,400.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES AUSTRALIA Pty Ltd Marketing of pharmaceuticals |
Australia | 200,000.00 | AUD | Line‐by‐line |
| TONIPHARM S.a.s. Marketing of pharmaceuticals |
France | 257,700.00 | EUR | Line‐by‐line |
| RECORDATI BULGARIA Ltd Marketing of pharmaceuticals |
Bulgaria | 50,000.00 | BGN | Line‐by‐line |
| RECORDATI (BEIJING) PHARMACEUTICAL CO., Ltd (1) Marketing of pharmaceuticals |
People's Republic of China |
1,000,000.00 | EUR | Line‐by‐line |
(1) Set up in 2021
| PERCENTAGE OF OWNERSHIP | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Consolidated companies | Recordati S.p.A. Parent Company |
Recordati Pharma GmbH |
Bouchara Recordati S.a.s. |
Casen Recordati S.L. |
Recordati Orphan Drugs S.a.s. |
Recordati Rare Diseases S.à r.l. |
Herbacos Recordati s.r.o. |
Recordati Ilaç A.Ş. |
Opalia Pharma S.A. |
Recordati AG |
Total |
| INNOVA PHARMA S.P.A. | 100.00 | 100.00 | |||||||||
| CASEN RECORDATI S.L. | 100.00 | 100.00 | |||||||||
| BOUCHARA RECORDATI S.A.S. | 100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES COMERCIO DE MEDICAMENTOS LTDA |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES INC. | 100.00 | 100.00 | |||||||||
| RECORDATI IRELAND LTD | 100.00 | 100.00 | |||||||||
| LABORATOIRES BOUCHARA RECORDATI S.A.S. |
100.00 | 100.00 | |||||||||
| RECORDATI PHARMA GmbH | 55.00 | 45.00 | 100.00 | ||||||||
| RECORDATI PHARMACEUTICALS LTD |
100.00 | 100.00 | |||||||||
| RECORDATI HELLAS PHARMACEUTICALS S.A. |
100.00 | 100.00 | |||||||||
| JABA RECORDATI S.A. | 100.00 | 100.00 | |||||||||
| JABAFARMA PRODUTOS FARMACÊUTICOS S.A. |
100.00 | 100.00 | |||||||||
| BONAFARMA PRODUTOS FARMACÊUTICOS S.A. |
100.00 | 100.00 | |||||||||
| RECORDATI ORPHAN DRUGS S.A.S. |
90.00 | 10.00 | 100.00 | ||||||||
| RECORDATI RARE DISEASES MIDDLE EAST FZ LLC |
100.00 | 100.00 | |||||||||
| RECORDATI AB | 100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES S.à r.l. |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES UK Limited |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES GERMANY GmbH |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES SPAIN S.L. |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES ITALY S.R.L. |
100.00 | 100.00 | |||||||||
| RECORDATI BV | 99.46 | 0.54 | 100.00 | ||||||||
| FIC MEDICAL S.à r.l. | 100.00 | 100.00 | |||||||||
| HERBACOS RECORDATI s.r.o. | 100.00 | 100.00 | |||||||||
| RECORDATI SK s.r.o. | 100.00 | 100.00 |
| PERCENTAGE OF OWNERSHIP | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Consolidated companies | Recordati S.p.A. Parent Company |
Recordati Pharma GmbH |
Bouchara Recordati S.a.s. |
Casen Recordati S.L. |
Recordati Orphan Drugs S.a.s. |
Recordati Rare Diseases S.à r.l. |
Herbacos Recordati s.r.o. |
Recordati Ilaç A.Ş. |
Opalia Pharma S.A. |
Recordati AG |
Total |
| RUSFIC LLC | 100.00 | 100.00 | |||||||||
| RECOFARMA ILAÇ Ve Hammaddeleri Sanayi Ve Ticaret L.Ş. |
100.00 | 100.00 | |||||||||
| RECORDATI ROMÂNIA S.R.L. | 100.00 | 100.00 | |||||||||
| RECORDATI İLAÇ Sanayi Ve Ticaret A.Ş. |
100.00 | 100.00 | |||||||||
| RECORDATI POLSKA Sp. z o.o |
100.00 | 100.00 | |||||||||
| ACCENT LLC | 100.00 | 100.00 | |||||||||
| RECORDATI UKRAINE LLC | 0.01 | 99.99 | 100.00 | ||||||||
| CASEN RECORDATI PORTUGAL Unipessoal Lda |
100.00 | 100.00 | |||||||||
| OPALIA PHARMA S.A. | 90.00 | 90.00 | |||||||||
| OPALIA RECORDATI S.à R.L. |
1.00 | 99.00 | 100.00 | ||||||||
| RECORDATI RARE DISEASES S.A. DE C.V. |
99.998 | 0.002 | 100.00 | ||||||||
| RECORDATI RARE DISEASES COLOMBIA S.A.S. |
100.00 | 100.00 | |||||||||
| ITALCHIMICI S.p.A. | 100.00 | 100.00 | |||||||||
| RECORDATI AG | 100.00 | 100.00 | |||||||||
| RECORDATI AUSTRIA GmbH | 100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES CANADA Inc. |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES JAPAN K.K. |
100.00 | 100.00 | |||||||||
| NATURAL POINT S.r.l. | 100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES AUSTRALIA Pty Ltd |
100.00 | 100.00 | |||||||||
| TONIPHARM S.a.s. | 100.00 | 100.00 | |||||||||
| RECORDATI BULGARIA Ltd | 100.00 | 100.00 | |||||||||
| RECORDATI (BEIJING) PHARMACEUTICAL CO., Ltd (1) |
100.00 | 100.00 |
(1) Set up in 2021
The manager responsible for preparing the company's financial reports, Luigi La Corte, declares, pursuant to paragraph 2 of Article 154‐bis of the Consolidated Law on Finance, that the accounting information contained in this document corresponds to the documentation, books and accounting records.
Milan, 28 October 2021
Luigi La Corte
Financial Reporting Manager
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