Quarterly Report • Oct 29, 2020
Quarterly Report
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FIRST NINE MONTHS 2020
INDEX
| Page | |
|---|---|
| MANAGEMENT REVIEW | 3 |
| Highlights | 3 |
| Corporate development news | 5 |
| Review of operations | 6 |
| Financial review | 11 |
| Business outlook | 15 |
| CONSOLIDATED FINANCIAL STATEMENTS AT 30 SEPTEMBER 2020 | 16 |
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS | 22 |
| ATTESTATION IN RESPECT OF THE CONSOLIDATED CONDENSED FINANCIAL STATEMENTS UNDER ARTICLE 154‐BIS OF LEGISLATIVE DECREE 58/98 |
48 |
| € (thousands) | First nine | First nine | Change | |||
|---|---|---|---|---|---|---|
| months 2020 | % | months 2019 | % | 2020/2019 | % | |
| Total net revenue | 1,093,818 | 100.0 | 1,100,418 | 100.0 | (6,600) | (0.6) |
| Italy | 208,523 | 19.1 | 220,597 | 20.0 | (12,074) | (5.5) |
| International | 885,295 | 80.9 | 879,821 | 80.0 | 5,474 | 0.6 |
| KEY CONSOLIDATED P&L DATA | ||||||
| € (thousands) | First nine months 2020 |
% of revenue |
First nine months 2019 |
% of revenue |
Change 2020/2019 |
% |
| Net revenue | 1,093,818 | 100.0 | 1,100,418 | 100.0 | (6,600) | (0.6) |
| EBITDA (1) | 438,801 | 40.1 | 409,612 | 37.2 | 29,189 | 7.1 |
| Operating income | 364,037 | 33.3 | 353,500 | 32.1 | 10,537 | 3.0 |
| Net income | 274,100 | 25.1 | 253,674 | 23.1 | 20,426 | 8.1 |
| Adjusted net income (2) | 317,548 | 29.0 | 282,796 | 25.7 | 34,752 | 12.3 |
| KEY CONSOLIDATED | B/S DATA | |||||
| € (thousands) | 30 September 2020 |
31 December 2019 |
Change 2020/2019 |
% | ||
| Net financial position (3) | (845,940) | (902,681) | 56,741 | (6.3) |
| € (thousands) Third quarter |
Third quarter | Change | ||||
|---|---|---|---|---|---|---|
| 2020 | % | 2019 | % | 2020/2019 | % | |
| Total net revenue | 333,626 | 100.0 | 357,165 | 100.0 | (23,539) | (6.6) |
| Italy | 60,038 | 18.0 | 65,500 | 18.3 | (5,462) | (8.3) |
| International | 273,588 | 82.0 | 291,665 | 81.7 | (18,077) | (6.2) |
Shareholders' equity 1,287.575 1,198,811 88,764 7.4
| € (thousands) | Third quarter 2020 |
% of revenue |
Third quarter 2019 |
% of revenue |
Change 2020/2019 |
% |
|---|---|---|---|---|---|---|
| Net revenue | 333,626 | 100.0 | 357,165 | 100.0 | (23,539) | (6.6) |
| EBITDA (1) | 127,710 | 38.3 | 130,299 | 36.5 | (2,589) | (2.0) |
| Operating income | 102,527 | 30.7 | 110,941 | 31.1 | (8,414) | (7.6) |
| Net income | 77,157 | 23.1 | 79,400 | 22.2 | (2,243) | (2.8) |
| Adjusted net income (2) | 91,980 | 27.6 | 89,659 | 25.1 | 2,321 | 2.6 |
(1) Net income before financial (income) expense, provision for taxes, depreciation, amortization and write down of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
(2) Net income excluding amortization and write‐down of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
(3) Short‐term financial investments, cash and cash equivalents, less bank overdrafts and loans which include the measurement at fair value of hedging derivatives.
Business activities in the third quarter of 2020 continued to be affected by the COVID‐19 pandemic due both to the local restrictions imposed to limit contagion in all territories, as well as to a cautious management of stocks by wholesalers. This, together with the further devaluation of most currencies with respect to the euro, negatively affected sales in the main countries in which the Group operates. Consequently, revenue at € 1,093.8 million is slightly down by 0.6% compared to the same period of the preceding year. International sales, conversely, increase by 0.6%, thanks to the contribution of the new products acquired in the second half of 2019. At constant currency exchange rates revenue increases by 1.1% over the same period of 2019.
While complying with all the measures necessary to ensure the health safety of its personnel, Recordati has continued its production and distribution activities without interruption and has adopted measures to guarantee the continued availability on the market of its products. For office personnel, operations not requiring the physical presence of people in the companies' offices continued to be carried out normally in home working mode, while our medical representatives gradually returned to their field activities that had been suspended during the most acute period of the epidemic, while respecting the medical assistance priorities of all healthcare workers, and continuing to supplement their activity through alternative communication means. In March, the Group allocated € 5 million to contribute gratuitously to the support of hospitals and health facilities in their fight against the epidemiologic emergency due to COVID‐19 in the areas most affected.
Despite the impact of the health emergency and the currency devaluations, EBITDA is € 438.8 million, or at 40.1% of sales, an increase of 7.1% over the first nine months of 2019, thanks to an increase in gross margin and the reduction of operating expenses stemming from lower activity in the field due to the health emergency. As previously communicated, to better represent the performance of the business, the definition of EBITDA, as from this year, has been integrated to exclude non‐recurring charges. As in preceding quarters, non‐recurring costs relate to the COVID‐19 epidemiological emergency for an amount of € 5.2 million which include donations already paid, while there were no non‐recurring charges in the first nine months of 2019.
Operating income, at 33.3% of sales, is € 364.0 million, an increase of 3.0% over the same period of the preceding year. Growth is lower than that recorded by EBITDA due to the increase in the amortization associated with the product acquisitions in 2019.
Net income, at 25.1% of sales, is € 274.1 million, an increase of 8.1% over the first nine months of 2019. Growth is due to the increase in operating income and the benefit from lower financial expenses and, thanks to the effect derived from the so‐called patent box, a lower effective tax rate.
As already illustrated in the preceding quarters, given the increased amount of intangible assets on the Group's balance sheet and their amortization, in order to provide information in line with best practice in the sector and to allow comparability with other players, as from this year a new performance indicator has been introduced, adjusted net income, which is net income excluding amortization and write‐down of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects. Adjusted net income is € 317.5 million, up by 12.3% over the same indicator calculated using the first nine months of 2019 results, with a margin of 29.0% of sales.
Net financial position at 30 September 2020 records a net debt of € 845.9 million compared to net debt of € 902.7 million at 31 December 2019. During the period milestones of \$ 90,0 million were paid to Novartis following the European and U.S. approval of Isturisa® and its launch in Germany, own shares were purchased for a total disbursement, net of disposals for the exercise of stock options, of € 15.6 million and dividends were paid for a total of € 110.5 million. Net of these effects cash generation during the period was of around € 267 million. Shareholders' equity is € 1,287.6 million.
In January, the European Commission granted marketing authorisation for the orphan medicinal product Isturisa® (osilodrostat), indicated for the treatment of endogenous Cushing's syndrome (CS) in adults. In March, the FDA approved Isturisa® for the treatment of patients with Cushing's disease, for whom pituitary surgery is not an option or has not been curative, in the U.S.A.. Both the European Commission and the FDA confirmed the orphan drug status of Isturisa®. Also, in March, the Japanese New Drug Application (JNDA) was submitted to the Ministry of Health, Labour and Welfare seeking marketing approval for osilodrostat. Furthermore, the marketing authorizations for Isturisa® were transferred to Recordati Rare Diseases both in the United States and in Europe, in March and April respectively, and the product was launched with initial sales in the second quarter in the U.S., France and Germany.
The active substance of Isturisa® is osilodrostat, a cortisol synthesis inhibitor. Osilodrostat works by inhibiting 11‐ beta‐hydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. The benefits of Isturisa® are its ability to control or normalise cortisol levels in adult CS patients with a manageable safety profile, making this product a valuable treatment option for patients with Cushing's syndrome. The data generated throughout the clinical program show that osilodrostat leads to normalisation of cortisol levels in the majority of patients, as well as improvement in multiple clinical features of the disease and quality of life, thereby providing significant clinical benefit in an area with unmet medical need. Particularly, in the LINC‐3 study a significantly higher proportion of patients in the Isturisa® arm maintained normal mUFC at the end of the 8‐week randomised withdrawal period (week 34) versus placebo (86.1% vs 29.4%). These positive results were confirmed by the LINC‐ 4 study which demonstrates that a significantly higher proportion of patients receiving Isturisa® achieve normal mUFC, the primary treatment goal for Cushing's disease, after 12 weeks of treatment versus placebo (77% vs 8%; P<0.0001). Improvements in mUFC levels are sustained over 36 weeks of treatment (81% of patients).
As per the agreement with Novartis, in the month of February the marketing authorizations for Signifor® and Signifor® LAR in the U.S. were transferred to Recordati Rare Diseases Inc. and direct marketing of these products on this market started. Consolidated revenue generated by Signifor®, Signifor® LAR and Isturisa® in the first nine months of 2020 is € 53.8 million.
In August, the U.S. Food and Drug Administration (FDA) granted approval for the marketing of Cystadrops® (cysteamine ophthalmic solution) 0.37% in the U.S.A and the product was subsequently launched on the market. Cystadrops® is a new, viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis. Cystadrops® demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the first and only FDA‐approved cysteamine drop formulation with four times a day dosing. Cystinosis is a rare genetic condition present from birth that leads to the build‐up of cystine crystals throughout the body, causing widespread tissue and organ damage and significant impact on the eyes.
In September, an exclusive license agreement with ARS Pharmaceuticals, a private U.S. pharmaceutical company, for the commercialization in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia/CIS, Turkey, Middle East and French‐speaking African countries, of ARS‐1, an epinephrine nasal spray in late‐ stage development for the emergency treatment of severe allergic reactions that can lead to anaphylaxis, was signed. The terms of the agreement provide for an upfront payment (€ 10 million paid in October) and further milestone payments linked to the regulatory process and commercial performance. Anaphylaxis is a severe, generalized allergic reaction, characterized by life‐threatening breathing or cardiovascular problems. The trigger is exogenous and can be associated with food, insect bites or other allergenic substances. ARS‐1 is a liquid formulation of epinephrine associated with Intravail®, an absorption enhancer, contained in a disposable, mono‐dose nasal spray device. Compared to existing products this innovative formulation represents a new easy‐to‐use and needle‐
free route of administration. With use at the first signs of allergic response, it could provide patients and their families the preventive solution to anaphylactic progression.
The Group's business is composed of two segments, that dedicated to specialty and primary care and the one dedicated to treatments for rare diseases, and is carried out directly in the main European markets, including Central and Eastern Europe, in Russia, Turkey, North Africa, the United States of America, Canada, Mexico, in some South American countries, in Japan and Australia through our own subsidiaries and in the rest of the world through licensing agreements with pharmaceutical companies of high standing.
Net revenue in the first nine months of 2020 is € 1,093.8 million, down by 0.6% over the same period of the preceding year, and includes revenue of € 53.8 million related to Signifor® and Signifor® LAR, realized starting 24 October 2019, and initial sales of Isturisa®, in addition to an estimated negative currency exchange rate effect of € 18.5 million. Excluding these items revenue would have been down by 3.8%, mainly due to the impact of the COVID‐ 19 pandemic on our reference markets and to the loss of Urorec®'s (silodosin) marketing exclusivity. International sales grow by 0.6% to € 885.3 million, which represent 80.9% of total sales.
* Excluding sales of pharmaceutical chemicals which are € 37.9 million, up by 11.3% and represent 3.5% of total revenue.
As already mentioned, the Group's revenue, mainly in the second and third quarters, suffered from the impact of the COVID‐19 pandemic on its reference markets, affecting mainly the Specialty and Primary Care segment. The more consolidated products for the treatment of chronic diseases continued to perform well, as confirmed by the growth of lercanidipine, pitavastatin and metoprolol. The negative impact was mainly caused by the reduction of procedures conducted in hospitals and clinics, such as endoscopies which have negatively affected Citrafleet® (colonoscopy preparation) in Spain; by the low incidence of some diseases due to the reduced activity of the population, which negatively affected the performance of the anti‐infectives Tergynan®, Polydexa® and Isofra® in Russia and in other Central and Eastern European countries; the reduced use of OTC products such as vitamins, food supplements and probiotics. The segment dedicated to the treatment of rare diseases was less affected, except for the sales of Panhematin® in the U.S.A. due to the lower number of patients visiting infusion centres,
mainly in the second quarter. The negative variances recorded regarding the abovementioned products are expected to be of a temporary nature as they are associated with the contingent COVID‐19 emergency.
The performance of products sold directly in more than one country (corporate products) during the first nine months of 2020 is shown in the table below.
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
% |
|---|---|---|---|---|
| Zanidip® (lercanidipine) | 106,083 | 102,216 | 3,867 | 3.8 |
| Zanipress® (lercanidipine+enalapril) | 38,234 | 44,377 | (6,143) | (13.8) |
| Urorec® (silodosin) | 58,488 | 82,694 | (24,206) | (29.3) |
| Livazo® (pitavastatin) | 42,450 | 40,001 | 2,449 | 6.1 |
| Seloken®/Seloken® ZOK/Logimax® (metoprolol/metoprolol+felodipine) |
77,699 | 72,479 | 5,220 | 7.2 |
| Other corporate products* | 198,689 | 225,496 | (26,807) | (11.9) |
| Drugs for rare diseases | 232,359 | 177,136 | 55,223 | 31.2 |
* Include the OTC corporate products for an amount of € 78.4 million in 2020 and € 84.7 million in 2019 (‐7.5%).
Zanidip® is a specialty containing lercanidipine, Recordati's original calcium channel blocker for the treatment of hypertension. Our lercanidipine based products are sold directly to the market by our own marketing organizations in Europe, including Central and Eastern Europe, in Russia, in Turkey and in North Africa. In the other markets they are sold by licensees, and in some of the above co‐marketing agreements are in place.
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
% |
|---|---|---|---|---|
| Direct sales | 57,551 | 55,462 | 2,089 | 3.8 |
| Sales to licensees | 48,532 | 46,754 | 1,778 | 3.8 |
| Total lercanidipine sales | 106,083 | 102,216 | 3,867 | 3.8 |
Lercanidipine direct sales are up by 3.8% due to growth mainly in Italy, Germany, Poland and Russia as well as to the direct sales by our organizations now operational in the Nordic countries and in BeNeLux, areas where sales were previously realized by our licensees. Sales to licensees, which represent 45.7% of total lercanidipine sales, are up by 3.8%, a lower growth rate than that in preceding quarters, due to the normalization of sales on international markets following higher orders in previous quarters.
Zanipress® is an original specialty also indicated for the treatment of hypertension developed by Recordati which consists of a fixed combination of lercanidipine with enalapril. This product is successfully marketed directly by Recordati and/or by its licensees in 30 countries.
| Total lercanidipine+enalapril sales | 38,234 | 44,377 | (6,143) | (13.8) |
|---|---|---|---|---|
| Sales to licensees | 4,117 | 4,707 | (590) | (12.5) |
| Direct sales | 34,117 | 39,670 | (5,553) | (14.0) |
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
% |
Direct sales of Zanipress® in the first nine months of 2020 are down by 14.0% due to the impact of the new measures introduced in France in favour of the use of generic products. Sales to licensees represent 10.8% of total Zanipress® sales and are down by 12.5% mainly due to the termination of the licenses in France and Belgium.
Urorec® (silodosin) is a specialty indicated for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). Currently the product is marketed in 40 countries with sales of € 58.5 million in the first nine months of 2020, down by 29.3% in line with expectations due to competition from generic versions of the product following the expiry of its marketing exclusivity, mainly in Italy, France, Spain and Germany. Urorec® is performing well in Turkey where generic versions are not present.
Sales of Livazo® (pitavastatin), a statin indicated for the reduction of elevated total and LDL cholesterol, in Spain, Portugal, Ukraine, Greece, Switzerland, Russia, other C.I.S. countries and Turkey, are € 42.5 million in the first nine months of 2020, up by 6.1% due mainly to the performance of the product in Turkey, Greece and Switzerland. In August 2020, the exclusivity covering the use of pitavastatin clinical data expired and consequently generic versions of the product are entering the market, mainly in Spain and Portugal.
Sales of Seloken®/Seloken® ZOK (metoprolol) and associated Logimax® fixed dose combination (metoprolol and felodipine), metoprolol based products belonging to the beta‐blocker class of drugs widely used in the treatment of various cardiovascular disorders, are of € 77.7 million in the first nine months of 2020, up by 7.2% compared to the same period of the preceding year thanks mainly to the growth of sales in the Central and Eastern European countries.
In the first nine months of 2020 sales of other corporate products totaled € 198.7 million, down by 11.9% compared to the same period of the preceding year due to lower sales of Citrafleet® and the other products used in the preparation for colonoscopies, a hospital procedure which was interrupted in recent months due to the COVID‐19 emergency, in addition to the low incidence of some diseases due to the reduced activity of the population, which negatively affected the performance of the anti‐infectives Tergynan®, Polydexa® and Isofra® in Russia and in other Central and Eastern European countries. Furthermore, sales were affected by the negative currency exchange effect in Turkey and Russia and the reduced demand for OTC products and food supplements. Other corporate products comprise both prescription and OTC products and are: Reagila® (cariprazine), Lomexin® (fenticonazole), Urispas® (flavoxate), Kentera® (oxybutynin transdermal patch), TransAct® LAT (flurbiprofen transdermal patch), Rupafin®/Wystamm® (rupatadine), Lopresor® (metoprolol), Procto‐Glyvenol® (tribenoside), Tergynan® (fixed association of anti‐infectives) as well as CitraFleet®, Casenlax®, Fleet enema, Phosphosoda®, Reuflor®/Reuteri® (lactobacillus Reuteri) and Lacdigest® (tilactase), gastroenterological products, Polydexa®, Isofra® and Otofa®, ENT anti‐infective products, the Hexa line of products indicated for seasonal disorders of the upper respiratory tract, Abufene® and Muvagyn® for gynecological use, Virirec® (alprostadil) and Fortacin® (lidocaine+prilocaine) for male sexual disorders.
In the first nine months of 2020, our specialties indicated for the treatment of rare diseases, marketed directly throughout Europe, in the Middle East, in the U.S.A., Canada, Mexico, in some South American countries, in Japan and Australia, and through partners in other parts of the world, generated sales of € 232.4 million, up by 31.2%, and include revenues from Signifor®, Signifor® LAR and Isturisa® for a total of € 53.8 million. Excluding the contribution from these products, acquired at the end of 2019, the growth of the products for the treatment of rare diseases would have been 0.8%. The continued growth of Carbaglu®, Cystadrops®, Cystadane® and Juxtapid® partly compensated for the reduction of the U.S.A. sales of Panhematin® (haemin for injection) which were affected by restricted access to infusion centres on account of the COVID‐19 emergency and to the entry of a competitive product for the amelioration of recurrent attacks of acute intermittent porphyria. The sales of products for the treatment of rare diseases in the rest of the world (ex U.S.A.), excluding revenues generated by Signifor®, Signifor® LAR and Isturisa®, grow by 11.5%.
Sales of pharmaceutical chemicals, which comprise active substances produced in the Campoverde d'Aprilia plant for the international pharmaceutical industry, are € 37.9 million, up by 11.3%, and account for 3.5% of total sales.
The sales of the Recordati subsidiaries, which include the abovementioned product sales but exclude sales of pharmaceutical chemicals, are shown in the following table.
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
% |
|---|---|---|---|---|
| Italy | 202,898 | 215,147 | (12,249) | (5.7) |
| France | 109,132 | 117,028 | (7,896) | (6.7) |
| Germany | 100,595 | 101,465 | (870) | (0.9) |
| U.S.A. | 89,418 | 78,342 | 11,076 | 14.1 |
| Russia, other C.I.S. countries and Ukraine | 69,089 | 83,589 | (14,500) | (17.3) |
| Spain | 63,079 | 69,420 | (6,341) | (9.1) |
| Turkey | 62,443 | 65,314 | (2,871) | (4.4) |
| Portugal | 32,557 | 32,979 | (422) | (1.3) |
| Other C.E.E. countries | 67,098 | 60,017 | 7,081 | 11.8 |
| Other Western European countries | 66,864 | 55,891 | 10,973 | 19.6 |
| North Africa | 33,372 | 30,288 | 3,084 | 10.2 |
| Other international sales | 159,341 | 156,871 | 2,470 | 1.6 |
| Total pharmaceutical revenue* | 1,055,886 | 1,066,351 | (10,465) | (1.0) |
* Both years include sales as well as other income and exclude sales of pharmaceutical chemicals.
Sales in countries affected by currency exchange oscillations are shown hereunder in their relative local currencies.
| Local currency (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
% |
|---|---|---|---|---|
| Russia (RUB) | 4,276,804 | 4,824,138 | (547,334) | (11.4) |
| Turkey (TRY) | 450,265 | 393,024 | 57,241 | 14,6 |
| U.S.A. (USD) | 100,598 | 88,026 | 12,572 | 14.3 |
Net revenues in Russia and in Turkey exclude sales of products for rare diseases.
Sales of pharmaceuticals in Italy are down by 5.7% compared to those of the same period of the preceding year mainly due to competition from generic versions of Urorec®, Peptazol® (pantoprazole) and Lovinacor®/Rextat® (lovastatin) in addition to weak consumption of self‐medication products, except for the eye drops Imidazyl® and Eumill®, during the health emergency. Worth mentioning is the good performance of Reagila®, Cardicor® (bisoprolol), Zanidip®/Lercadip® (lercanidipine) as well as the significant growth of treatments for rare diseases that include the newly acquired endocrinology products Signifor® and Signifor® LAR.
Pharmaceutical sales in France are down by 6.7% mainly due to generic competition for Urorec® and the impact on the lercanidipine based products of the new measures introduced at the beginning of the year which further promote the adoption of generic drugs. Worth noting is the good performance of methadone sales and the significant growth of treatments for rare diseases that include the newly acquired endocrinology products Signifor®, Signifor® LAR and Isturisa®.
Sales in Germany are down by 0.9% compared with those of the same period of the preceding year due to competition from generic versions of Ortoton® (methocarbamol). Worth mentioning is the performance of
Claversal® (mesalazina) and lercanidipine, as well as Mirfulan® and Laxbene®, OTC products. Furthermore, treatments for rare diseases, that include the newly acquired endocrinology products Signifor®, Signifor® LAR and Isturisa®, grow significantly.
The Group's pharmaceutical business in the U.S.A. is dedicated to the marketing of products for the treatment of rare diseases. Sales in the first nine months of 2020 are € 89.4 million, up by 14.1% and by 14.3% in local currency. Growth reflects mainly the contribution from the newly acquired endocrinology products Signifor® and Signifor® LAR (pasireotide) for the treatment of Cushing's disease and acromegaly, and the launch of Isturisa® (osilodrostat) for the treatment of Cushing's disease, together with the continued growth of Carbaglu® (carglumic acid), indicated for the treatment of acute hyperammonaemia associated with NAGS deficiency and Cystadane® (betaine anhydrous) indicated in the treatment of homocystinuria. Sales of Panhematin® (haemin for injection) for the amelioration of recurrent attacks of acute intermittent porphyria, instead, are down following the entry of a competitive product.
Revenue generated in Russia, Ukraine and in the countries within the Commonwealth of Independent States (C.I.S.) is € 69.1 million, down by 17.3% compared to the same period of the preceding year and includes estimated currency exchange losses of € 5.2 million. In addition to the devaluation of the ruble, activities in these areas were particularly affected by the COVID‐19 epidemiological emergency. Sales in Russia, in local currency, are RUB 4,276.8 million, down by 11.4% compared to the same period of the preceding year mainly due to the reduction of products for seasonal infections. Worth mentioning is the significant growth of the corporate products Zanidip®, Livazo® and Urorec® in addition to the self‐medication products Procto‐Glyvenol® and Abufene®. Sales generated in Ukraine and in the C.I.S. countries, mainly Belarus, Kazakhstan and Armenia are € 13.2 million, down by 15.9%.
In Spain sales are € 63.1 million, down by 9.1% mainly due to the reduced sales of products associated with hospital procedures, temporarily suspended because of the COVID‐19 epidemiological emergency (Citrafleet® and Enema Casen) and to the competition from generic versions of Urorec® and Livazo®. Worthy of note is the good performance of Reagila® and the significant growth of the treatments for rare diseases.
Sales in Turkey are € 62.4 million, down by 4.4%, and include a negative currency exchange effect estimated to be of € 11.7 million. In local currency sales of our Turkish subsidiary grow by 14.6% thanks to an overall price increase and to the good performance of all the corporate products, in particular Livazo®, Urorec®, Lercadip®, Zanipress®, and Procto‐Glyvenol®, as well as the local products Mictonorm® (propiverine), Cabral® (phenyramidol), Kreval® (butamirate citrate) and Colchicum® (colchicine).
Sales in Portugal are down by 1.3% mainly due to the competition from generic versions of Urorec® and Zanipress® as well as to the weak sales of self‐medication products. Worthy of note is the good performance of Cloxam® (cloxazolam), Carzap® (candesartan cilexetil), the launch of Reagila® and the significant sales growth of the treatments for rare diseases. During the third quarter generic versions of Livazo® entered the Portuguese market.
Sales in other Central and Eastern European countries include the sales of Recordati subsidiaries in Poland, the Czech Republic, Slovakia, Romania, Bulgaria and the Baltic countries, in addition to sales of rare disease treatments in this area as well as in Hungary. In the first nine months of 2020 overall sales are up by 11.8% thanks mainly to the growth of sales in the Czech Republic, Poland and Romania in addition to the entry into Bulgaria and the Baltic countries. The main products in the portfolios of these subsidiaries are those based on metoprolol. Sales of the treatments for rare diseases in these countries grow by 83.3%.
Sales in other countries in Western Europe, up by 19.6%, comprise sales of products for the treatment of rare diseases in these countries (+37.3%) and sales of specialty and primary care products generated by the Recordati subsidiaries in the United Kingdom, Ireland, Greece, Switzerland, in the Nordic countries (Finland, Sweden, Denmark, Norway and Iceland) and in BeNeLux. Sales are growing in all countries and the strong increase is to be
attributed mainly to the direct commercialization of our corporate products by Recordati organizations in the Nordic countries and in BeNeLux where sales were previously made through licensees.
Sales in North Africa are € 33.4 million, up by 10.2% over the same period of the preceding year, and comprise both the export sales generated by Laboratoires Bouchara Recordati in these territories, in particular in Algeria, and sales generated by Opalia Pharma, the Group's Tunisian subsidiary. Sales in Tunisia in the first nine months of 2020 are up by 10.2%.
Other international sales are up by 1.6% as compared to the same period of the preceding year and comprise the sales to, and other revenues from, our licensees for our corporate products, Laboratoires Bouchara Recordati's and Casen Recordati's export sales, as well as the sales of products for the treatment of rare diseases in the rest of the world. The increase is to be attributed mainly to the good sales performance of the treatments for rare diseases and particularly to the sales in Japan thanks to the contribution from Juxtapid® and the addition of Signifor® and Signifor® LAR to the portfolio.
The following table shows the profit and loss accounts, including their expression as a percent of sales and change versus the first nine months of 2019:
| € (thousands) | First nine months 2020 |
% of revenue |
First nine months 2019 |
% of revenue |
Change 2020/2019 |
% |
|---|---|---|---|---|---|---|
| Revenue | 1,093,818 | 100.0 | 1,100,418 | 100.0 | (6,600) | (0.6) |
| Cost of sales | (308,237) | (28.2) | (329,069) | (29.9) | 20,832 | (6.3) |
| Gross profit | 785,581 | 71.8 | 771,349 | 70.1 | 14,232 | 1.8 |
| Selling expenses | (256,701) | (23.5) | (273,446) | (24.8) | 16,745 | (6.1) |
| Research and development expenses | (106,344) | (9.7) | (91,581) | (8.3) | (14,763) | 16.1 |
| General and administrative expenses | (53,644) | (4.9) | (51,740) | (4.7) | (1,904) | 3.7 |
| Other income (expense), net | (4,855) | (0.4) | (1,082) | (0.1) | (3,773) | n.s. |
| Operating income | 364,037 | 33.3 | 353,500 | 32.1 | 10,537 | 3.0 |
| Financial income (expense), net | (11,192) | (1.0) | (15,980) | (1.5) | 4,788 | (30.0) |
| Pretax income | 352,845 | 32.3 | 337,520 | 30.7 | 15,325 | 4.5 |
| Provision for income taxes | (78,745) | (7.2) | (83,846) | (7.6) | 5,101 | (6.1) |
| Net income | 274,100 | 25.1 | 253,674 | 23.1 | 20,426 | 8.1 |
| Adjusted net income (1) | 317,548 | 29.0 | 282,796 | 25,7 | 34,752 | 12.3 |
| EBITDA (2) | 438,801 | 40.1 | 409,612 | 37,2 | 29,189 | 7.1 |
(1) Net income excluding amortization and write‐down of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
(2) Net income before financial (income) expense, provision for taxes, depreciation, amortization and write down of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
Revenue for the period is € 1,093.8 million, an increase of € 6.6 million compared to the first nine months of 2019. For a detailed analysis please refer to the preceding "Review of Operations".
Gross profit is € 785.6 million with a margin of 71.8% on sales, an improvement compared to that of the same period of the preceding year due mainly to a larger proportion of products with higher margins.
Selling expenses decrease by 6.1% mainly due to the significant reduction of promotional activities as a result of the restrictions introduced in all markets to counter the COVID‐19 epidemiological emergency, with a consequent decrease as a percent of revenue compared to the same period of the preceding year.
Research and development expenses are € 106.3 million, up by 16.1% compared to those recorded in the first nine months of the preceding year due to the advancement of new development programs and the amortization of the rights to the new products Signifor®, Signifor® LAR and, as from the second quarter also Isturisa®, acquired from Novartis in October 2019.
General and administrative expenses are up by 3.7%, due mainly to the reinforcement of the organization in support of the endocrinology business unit but are substantially unchanged as percent of sales.
Other expense, net of other income, is € 4.9 million and includes costs of € 5.2 million related to the COVID‐19 epidemiological emergency, mainly composed of donations to hospitals.
EBITDA (net income before financial (income) expense, provision for taxes, depreciation, amortization and write down of property, plant and equipment, intangible assets and goodwill, and exceptional non‐recurring items), at 40.1% of sales, is € 438.8 million, an increase of 7.1% over the first nine months of 2019. Total depreciation and amortization charges, classified in the lines above, are € 69.6 million, of which amortization charges are € 50.6 million, an increase of € 12.8 million over the same period of the preceding year mainly resulting from the acquisition of the rights to Signifor®, Signifor® LAR and Isturisa® from Novartis in October 2019, and depreciation charges are € 19.0 million, up by € 0.6 million compared to the first nine months of 2019. Costs related to non‐ recurring events are € 5.2 million and are relative to the COVID‐19 epidemiological emergency, mainly donations to hospitals.
The reconciliation of net income with EBITDA* is reported below.
| € (thousands) | First nine months 2020 |
First nine months 2019 |
|---|---|---|
| Net income | 274,100 | 253,674 |
| Financial (income) expenses, net | 78,745 | 83,846 |
| Provision for income taxes | 11,192 | 15,980 |
| Depreciation, amortization and write‐downs | 69,582 | 56,112 |
| Non‐recurring items | 5,182 | 0 |
| EBITDA* | 438,801 | 409,612 |
* Net income before financial (income) expense, provision for taxes, depreciation, amortization and write down of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
| € (migliaia) | First nine months 2020 |
First nine months 2019 |
5B3Change 2020/2019 |
10B8% |
|---|---|---|---|---|
| Specialty and Primary Care segment | 321,823 | 321,832 | (9) | n.s. |
| Rare diseases segment | 116,978 | 87,780 | 29,198 | 33.3 |
| Total EBITDA* | 438,801 | 409,612 | 29,189 | 7.1 |
* Net income before financial (income) expense, provision for taxes, depreciation, amortization and write down of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
The EBITDA margin on sales of Specialty and Primary Care products is 37.4%, while that on sales of treatments for rare diseases is 50.3%, both increased compared to those in the first nine months of 2019.
Net financial charges are € 11.2 million, a decrease of € 4.8 million compared to the same period of the preceding year. Interest charges on loans increased by € 2.6 million, mainly following new loans raised, while short term positions generated net gains of € 1.3 million compared to net charges of € 4.2 million in the first nine months of 2019. During the year the Parent company repaid in advance to the U.S. company Recordati Rare Diseases Inc. two loans stipulated in November 2016 for an overall amount of \$ 70 million (which correspond to the two tranches of the notes privately placed by the US subsidiary in 2013) and extinguished the relative cross‐currency swaps. Following the early reimbursement of the notes in the first half of 2019, the derivative financial instruments no longer qualified as hedging instruments and their change in fair value was recognized to the profit and loss, net of the effect of the conversion of the loans to the current Euro/Dollar exchange rate. The settlement of the cross‐ currency swaps gave rise to a gain, net of the currency exchange loss associated with the reimbursement of the intercompany loans and bank charges, of € 2.6 million.
The effective tax rate during the period is 22.3%, lower than that of the same period of the preceding year due to the tax benefit provided by the so‐called "patent box". Following the agreement reached with 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 period 2015 to 2019, the Parent Company has decided to adhere – instead of renewing the agreement – to the new optional reverse charge mechanism provided for by art. 4 of the 30 April 2019 legislative decree number 34, and therefore determine directly in its tax returns the discount on taxable income provided by the "patent box" for the current year, using the same criteria agreed with the tax authorities for the preceding five‐year period. The accrued benefit for the first half 2020, booked as a reduction in taxes, is € 6.4 million.
Net income is € 274.1 million, or 25.1% of sales, an increase of 8.1% over the same period of the preceding year thanks to the increase in operating income and the benefit from lower financial expenses and the reduction of the effective tax rate.
Adjusted net income* is € 317.5 million and excludes amortization and write‐down of intangible assets (except software) and goodwill for an amount of € 39.6 million, and non‐recurring items for an amount of € 3.8 million, both net of tax effects.
The reconciliation of net income with adjusted net income* is reported below.
| € (thousands) | First nine months 2020 |
First nine months 2019 |
|---|---|---|
| Net income | 274,100 | 253,674 |
| Amortization and write‐down of intangible assets (excluding software) | 50,371 | 37,511 |
| Tax effect | (10,732) | (8,389) |
| Non‐recurring items | 5,182 | 0 |
| Tax effect | (1,373) | 0 |
| Adjusted net income* | 317,548 | 282,796 |
* Net income excluding amortization and write‐down of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
The net financial position is set out in the following table:
| € (thousands) | 30 September 2020 |
31 December 2019 |
52BChange 2019/2018 |
% |
|---|---|---|---|---|
| Cash and short‐term financial investments | 277,622 | 187,923 | 89,699 | 47.7 |
| Bank overdrafts and short‐term loans | (14,729) | (13,392) | (1,337) | 10.0 |
| Loans – due within one year (1) | (211,060) | (140,963) | (70,097) | 49.7 |
| Leasing liabilities – due within one year | (8,889) | (8,854) | (35) | 0.4 |
| Net liquid assets | 42,944 | 24,714 | 18,230 | 73.8 |
| Loans – due after one year (1) | (870,547) | (908,542) | 37,995 | (4.2) |
| Leasing liabilities – due after one year | (18,337) | (18,853) | 516 | (2.7) |
| Net financial position | (845,940) | (902,681) | 56,741 | (6.3) |
(1) Includes change in fair value of the relative currency risk hedging instruments (cash flow hedge).
At 30 September 2020, the net financial position shows a net debt of € 845.9 million compared to net debt of € 902.7 million at 31 December 2019. During the period milestones of \$ 90.0 million (€ 81.6 million) were paid to Novartis following the marketing authorization for Isturisa® in Europe and in the United States and its launch in Germany, and € 2.5 million were paid to Helsinn according to the license agreement covering Ledaga®. Furthermore, own shares were purchased for a total, net of disposals due to the exercising of stock options, of € 15.6 million and dividends were paid for a total of € 110.5 million. The analysis of the financial position net of the abovementioned effects confirms the Group's solid cash generation of around € 267 million during the period.
The Group's direct controlling company is FIMEI S.p.A., headquartered in Milan, via Vecchio Politecnico 9, Italy, which since 2018 is owned by a consortium of investors controlled by CVC Capital Partners.
Tax receivables include an amount of € 14.7 million, computed by Recordati S.p.A. based on estimated taxable income, receivable from the direct controlling company FIMEI S.p.A. consequent to the participation in a tax consolidation grouping under tax laws in Italy. The amount includes the effect of the so‐called "patent box", for the part related to corporate tax, both relative to the years 2015‐2019, as agreed with the Italian tax authorities in December 2019, and to the first half of 2020.
On October 1st, 2020, the Company's Board of Directors approved the reverse merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. in Recordati S.p.A.. The merger aims to achieve a shortening the chain of control with respect to the operating companies, obtaining, for the benefit of the majority shareholders and the entire Group, a simplification of the Group's corporate structure and the reduction of administrative costs associated with maintaining the companies to be incorporated (Rossini Investimenti S.p.A. and FIMEI S.p.A.) and, for the incorporating company (Recordati S.p.A.), lower taxes due to transfer of tax incentives from Rossini Investimenti, subject to Italian tax ruling.
It should be noted that the Merger will not entail any change to the share capital of the incorporating company nor is any balancing cash payment planned. Furthermore, the balance sheet and earnings profile of the entity resulting from the Merger will be substantially in line with that of the incorporating company at present and, in particular, the Merger will not alter the net financial position and, therefore, the investment capacity of Recordati or the strategy or its capital allocation policy. For further information please refer to Note 27 of the Notes to the Consolidated Financial Statements.
As previously described, despite the results of the first nine months having been impacted by the COVID‐19 epidemiological emergency, both operating income and net income continued to grow and are in line with expectations thanks to the positive contribution of the new products and the reduction of expenses. The persistence of the pandemic will continue to affect Group sales also in the fourth quarter with full year 2020 sales expected to be slightly below those recorded in 2019, due also to a negative foreign currency effect. However, thanks to lower expenses and an improvement in margins, EBITDA (1) and adjusted net income (2) are expected to be in line with the targets announced at the beginning of the year.
(1) Net income before financial (income) expense, provision for taxes, depreciation, amortization and write down of property, plant and equipment, intangible assets and goodwill, and non‐recurring items.
(2) Net income excluding amortization and write‐down of intangible assets (except software) and goodwill, and non‐recurring items, net of tax effects.
Milan, 29 October 2020
on behalf of the Board of Directors the Chief Executive Officer Andrea Recordati
CONSOLIDATED INCOME STATEMENT
| € (thousands) (1) | Note | First nine months 2020 |
First nine months 2019 |
|---|---|---|---|
| Revenue | 3 | 1,093,818 | 1,100,418 |
| Cost of sales | 4 | (308,237) | (329,069) |
| Gross profit | 785,581 | 771,349 | |
| Selling expenses | 4 | (256,701) | (273,446) |
| Research and Development expenses | 4 | (106,344) | (91,581) |
| General and Administrative expenses | 4 | (53,644) | (51,740) |
| Other income (expense), net | 4 | (4,855) | (1,082) |
| Operating income | 364,037 | 353,500 | |
| Financial income (expense), net | 5 | (11,192) | (15,980) |
| Pretax income | 352,845 | 337,520 | |
| Provision for income taxes | 6 | (78,745) | (83,846) |
| Net income | 274,100 | 253,674 | |
| Attributable to: | |||
| Equity holders of the parent | 274,063 | 253,642 | |
| Non‐controlling interests | 37 | 32 | |
| Earnings per share | |||
| Basic | € 1.333 | € 1.239 | |
| Diluted | € 1.311 | € 1.213 |
(1) Except for share and per‐share amounts.
Earnings per share (EPS) are based on average shares outstanding during each year, 205,603,780 in 2020 and 204,706,235 in 2019, net of average treasury stock which amounted to 3,521,376 shares in 2020 and to 4,418,921 shares in 2019.
Diluted earnings per share is calculated taking into account stock options granted to employees.
CONSOLIDATED BALANCE SHEET
| ASSETS | |||
|---|---|---|---|
| € (thousands) | Note | 30 September | 31 December |
| 2020 | 2019 | ||
| Non‐current assets | |||
| Property, plant and equipment | 7 | 129,739 | 133,342 |
| Intangible assets | 8 | 1,125,534 | 1,161,760 |
| Goodwill | 9 | 561,960 | 577,973 |
| Other investments | 10 | 28,933 | 38,566 |
| Other non‐current assets | 11 | 6,742 | 16,426 |
| Deferred tax assets | 12 | 78,077 | 71,513 |
| Total non‐current assets | 1,930,985 | 1,999,580 | |
| Current assets | |||
| Inventories | 13 | 250,334 | 226,885 |
| Trade receivables | 13 | 269,982 | 296,961 |
| Other receivables | 13 | 57,138 | 79,949 |
| Other current assets | 13 | 13,620 | 7,683 |
| Fair value of hedging derivatives (cash flow hedge) | 14 | 10,465 | 9,949 |
| Short‐term financial investments, cash and cash equivalents | 15 | 277,622 | 187,923 |
| Total current assets | 879,161 | 809,350 | |
| Total assets | 2,810,146 | 2,808,930 |
CONSOLIDATED BALANCE SHEET
| € (thousands) | Note | 30 September | 31 December |
|---|---|---|---|
| 2020 | 2019 | ||
| Shareholders' equity | |||
| Share capital | 26,141 | 26,141 | |
| Additional paid‐in capital | 83,719 | 83,719 | |
| Treasury stock | (92,295) | (93,480) | |
| Hedging reserve (cash flow hedge) | (3,054) | (5,357) | |
| Translation reserve | (207,332) | (146,866) | |
| Other reserves | 54,825 | 64,651 | |
| Retained earnings | 1,151,237 | 999,708 | |
| Net income for the period | 274,063 | 368,825 | |
| Interim dividend | 0 | (98,764) | |
| Shareholders' equity attributable to the holders of the Parent | 1,287,304 | 1,198,577 | |
| Non‐controlling interests | 271 | 234 | |
| Total shareholders' equity | 16 | 1,287,575 | 1,198,811 |
| Non‐current liabilities | |||
| Loans – due after one year | 17 | 898,967 | 937,344 |
| Staff leaving indemnities | 18 | 20,077 | 20,557 |
| Deferred tax liabilities | 19 | 41,296 | 43,172 |
| Other non‐current liabilities | 20 | 20,338 | 22,292 |
| Total non‐current liabilities | 980,678 | 1,023,365 | |
| Current liabilities | |||
| Trade payables | 21 | 145,204 | 175,481 |
| Other payables | 21 | 87,765 | 185,706 |
| Tax liabilities | 21 | 37,066 | 21,094 |
| Other current liabilities | 21 | 11,298 | 12,543 |
| Provisions | 21 | 16,186 | 17,933 |
| Fair value of hedging derivatives (cash flow hedge) | 22 | 9,696 | 10,788 |
| Loans – due within one year | 17 | 219,949 | 149,817 |
| Bank overdrafts and short‐term loans | 23 | 14,729 | 13,392 |
| Total current liabilities | 541,893 | 586,754 | |
| Total equity and liabilities | 2,810,146 | 2,808,930 | |
STATEMENT OF COMPREHENSIVE INCOME
| € (thousands) | First nine months | First nine months |
|---|---|---|
| 2020 | 2019 | |
| Net income for the period | 274,100 | 253,674 |
| Gains/(losses) on cash flow hedges, net of tax | 2,303 | 318 |
| Gains/(losses) on translation of foreign financial statements | (60,466) | 19,651 |
| Gains/(losses) on equity‐accounted investees, net of tax | (9,333) | 8,596 |
| Other changes, net of tax | (208) | 0 |
| Income and expense for the period recognized directly in equity | (67,704) | 28,565 |
| Comprehensive income for the period | 206,396 | 282,239 |
| Attributable to: | ||
| Equity holders of the parent | 206,359 | 282,207 |
| Non‐controlling interests | 37 | 32 |
| Earnings per share | ||
| Basic | € 1.004 | € 1.379 |
| Diluted | € 0.987 | € 1.350 |
(1) Except for share and per‐share amounts.
Earnings per share (EPS) are based on average shares outstanding during each year, 205,603,780 in 2020 and 204,706.235 in 2019, net of average treasury stock which amounted to 3,521.376 shares in 2020 and to 4,418,921 shares in 2019.
Diluted earnings per share is calculated taking into account stock options granted to employees.
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
| Attributable to equity holders of the Parent | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| € (thousands) | Share | Additional | Treasury | Hedging | Translation | Other | Retained | Net income | Interim | Non‐con‐ | Total |
| capital | paid‐in | stock | reserve | reserve | reserves | earnings | for the | dividend | trolling | ||
| capital | period | interests | |||||||||
| Balance at 31.12.2018* | 26,141 | 83,719 (145,608) | (8,399) | (154,146) | 43,081 | 897,990 | 312,376 (91,761) | 193 | 963,586 | ||
| Allocation of 2018 net income: |
|||||||||||
| ‐ Dividends | 29,486 | (217,330) | 91,761 | (96,083) | |||||||
| ‐ Retained earnings | 95,046 | (95,046) | 0 | ||||||||
| Change in the reserve for share‐based payments |
3,023 | 2,264 | 5,287 | ||||||||
| Disposal of own shares | 47,706 | (23,700) | 24,006 | ||||||||
| Other changes Comprehensive income |
583 | 583 | |||||||||
| for the period | 318 | 19,651 | 8,596 | 253,642 | 32 | 282,239 | |||||
| Balance at 30.9.2019 | 26,141 | 83,719 | (97,902) | (8,081) | (134,495) | 54,700 | 1,001,669 | 253,642 | 0 | 225 | 1,179,618 |
| Balance at 31.12.2019 | 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: |
|||||||||||
| ‐ Dividends | 35,669 | (241,092) | 98,764 | (106,659) | |||||||
| ‐ Retained earnings | 127,733 | (127,733) | 0 | ||||||||
| Change in the reserve for | |||||||||||
| share‐based payments | (285) | 3,934 | 3,649 | ||||||||
| Purchase of own shares | (47,871) | (47,871) | |||||||||
| Disposal of own shares | 49,056 | (16,817) | 32,239 | ||||||||
| Other changes | 1,010 | 1,010 | |||||||||
| Comprehensive income for the period |
2,303 | (60,466) | (9,541) | 274,063 | 37 | 206,396 | |||||
| Balance at 30.9.2020 | 26,141 | 83,719 | (92,295) | (3,054) | (207,332) | 54,825 | 1,151,237 | 274,063 | 0 | 271 | 1,287,575 |
*The Group has initially applied IFRS 16 at 1 January 2019, using the modified retrospective approach. Under this approach, comparative information is not restated and the possible cumulative effect of initially applying IFRS 16, not significant for the Group, is recognised in retained earnings at the date of initial application.
CONSOLIDATED CASH FLOW STATEMENT
| € (thousands) | First nine months 2020 |
First nine months 2019 |
|---|---|---|
| Cash flow from operating activities | ||
| Net Income | 274,100 | 253,674 |
| Depreciation of property, plant and equipment | 18,975 | 18,348 |
| Amortization of intangible assets | 50,607 | 37,764 |
| Equity‐settled share‐based payment transactions | 3,649 | 5,287 |
| Total | 347,331 | 315,073 |
| (Increase)/decrease in deferred tax assets | (6,314) | 7,801 |
| Increase/(decrease) in staff leaving indemnities | (480) | (32) |
| Increase/(decrease) in other non‐current liabilities | (4,503) | (1,325) |
| 336,034 | 321,517 | |
| Changes in working capital | ||
| Trade receivables | 6,822 | (31,629) |
| Inventories | (43,361) | (7,370) |
| Other receivables and other current assets | 26,604 | 2,751 |
| Trade payables | (37,651) | (16,841) |
| Tax liabilities | 15,972 | (4,093) |
| Other payables and other current liabilities | (13,596) | (6,403) |
| Provisions | (1,747) | (4,534) |
| Changes in working capital | (46,957) | (68,119) |
| Net cash and cash equivalents from (used in) operating activities | 289,077 | 253,398 |
| Cash flow from investing activities | ||
| Net (investments)/disposals in property, plant and equipment | (13,213) | (14,102) |
| Net (investments)/disposals in intangible assets | (92,242) | (61,909) |
| Net (increase)/decrease in other non‐current receivables | (46) | (277) |
| Net cash and cash equivalents from (used in) investing activities | (105,501) | (76,288) |
| Cash flow from financing activities | ||
| Loans granted | 110.183 | 418.750 |
| Re‐payment of loans | (73,409) | (111,948) |
| Payment of lease liabilities | (7,246) | (7,311) |
| Purchase of treasury stock | (47,871) | 0 |
| Sale of treasury stock | 32,239 | 24,006 |
| Other changes in equity | 4,257 | 583 |
| Dividends paid | (110,541) | (96,083) |
| Net cash and cash equivalents from/ (used in) financing activities | (92,388) | 227,997 |
| Changes in net cash and cash equivalents | 91,188 | 405,107 |
| Net cash and cash equivalents at beginning of period * | 174,531 | 181,131 |
| Exchange rate effect | (2,826) | 10,244 |
| Net cash and cash equivalents at end of period * | 262,893 | 596,482 |
* Includes cash and cash equivalents net of bank overdrafts and short‐term loans.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE PERIOD ENDED 30 SEPTEMBER 2020
The consolidated financial statements of the Recordati group for the period ended 30 September 2020 have been prepared by Recordati Industria Chimica e Farmaceutica S.p.A. (the "Company" or the "Parent"), with offices at Via Matteo Civitali 1, Milan, Italy, and were approved by the Board of Directors on 29 October 2020 that authorised their public disclosure.
The consolidated financial statements for the period ended 30 September 2020 comprise those of the "Parent" and all its controlled subsidiaries. The companies included in the consolidated accounts, the consolidation method applied, their percentage of ownership and a description of their activity are set out in Note 28. During the first nine months of 2020 the consolidation perimeter remained unchanged.
These financial statements are presented in euro (€) and all amounts are rounded to the nearest thousand euro unless otherwise stated.
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 2019, prepared in accordance with the IFRS, issued by the International Accounting Standards Board (IASB) and adopted by the European Union.
The preparation of the interim financial statements requires management to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements. If in the future such estimates and assumptions, which are based on management's best judgment at the date of the interim financial statements, deviate from the actual circumstances, the original estimates and assumptions will be modified as appropriate in the period in which the circumstances change. The estimates and hypothesis made during the preparation of the consolidated condensed financial statements take into account the impacts, even if potential, determined by the COVID‐19 pandemic. Valuation exercises, in particular complex calculations such as those required to identify impairment loss, are carried out in depth only for the preparation of the year‐end consolidated financial statements, except when there is an indication that an asset has suffered an impairment loss which would require an immediate estimate of the loss.
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 utilized in establishing the fair value. The following levels are used:
Disclosure of the net financial position is included under the preceding management review.
The accounting policies adopted in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the Group's last annual consolidated financial statements.
The Group's operations and main revenue streams are those described in the last annual financial statements. The Group's revenue is derived from contracts with customers and is not subject to seasonal fluctuations.
Net revenue for the first nine months of 2020 is € 1,093.8 million (€ 1,100.4 million in the same period of the preceding year) and can be broken down as follows:
| Total revenue | 1,093,818 | 1,100,418 | (6,600) |
|---|---|---|---|
| Various revenues | 21,196 | 5,115 | 16,081 |
| Up‐front payments | 3,521 | 4,673 | (1,152) |
| Royalties | 4,141 | 5,107 | (966) |
| Net sales | 1,064,960 | 1,085,523 | (20,563) |
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
Up‐front payments relate to the licensing and distribution of the portfolio products and are recognized over the period of the collaboration with the customers. Revenue from up‐front payments of € 3.5 million recorded in the first nine months of 2020 refer mainly to license agreements for pitavastatin (€ 1.1 million), lercanidipine (€ 0.7 million), Cystadrops® (cysteamine hydrochloride) (€ 0.6 million), the lercanidipine‐enalapril combination (€ 0.4 million) and 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 current liabilities (see Note 21), is of € 10.0 million (€ 11.9 million at 31 December 2019).
The increase in the line "Various revenues" is mainly due to the contractual margin on sales realized by Novartis, on behalf of Recordati, of Signifor® and Signifor® LAR for an amount of € 19.5 million, following the acquisition of the rights on 23 October 2019. In addition to these, € 28.9 million, booked to net sales, were recorded following marketing authorisation transfer in the U.S.A and progressively in Europe and other geographic areas. Starting from the second quarter 2020 Recordati launched Isturisa® in the U.S.A., in France and in Germany with combined sales of 5.4 million.
In the following tables, revenue is disaggregated by product or product class and by geographical areas. 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 |
|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | |
| Zanidip® | 106,083 | 102,216 | ‐ | ‐ | 106,083 | 102,216 |
| Zanipress® | 38,234 | 44,377 | ‐ | ‐ | 38,234 | 44,377 |
| Urorec® | 58,488 | 82,694 | ‐ | ‐ | 58,488 | 82,694 |
| Livazo® | 42,450 | 40,001 | ‐ | ‐ | 42,450 | 40,001 |
| Seloken®/Logimax® | 77,699 | 72,479 | ‐ | ‐ | 77,699 | 72,479 |
| Other corporate products | 120,303 | 140,773 | ‐ | ‐ | 120,303 | 140,773 |
| Drugs for rare diseases | 232,359 | 177,136 | 232,359 | 177,136 | ||
| OTC | 198,608 | 203,559 | ‐ | ‐ | 198,608 | 203,559 |
| Local product portfolios | 174,345 | 193,576 | ‐ | ‐ | 174,345 | 193,576 |
| Other revenue | 7,317 | 9,540 | ‐ | ‐ | 7,317 | 9,540 |
| Pharmaceutical chemicals | 37,392 | 34,067 | ‐ | ‐ | 37,392 | 34,067 |
| Total net revenue | 861,459 | 923,282 | 232,359 | 177,136 | 1,093,818 | 1,100,418 |
| € (thousands) | Specialty and Primary Care |
Specialty and Primary Care |
Rare Diseases |
Rare Diseases |
Total | Total |
|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | |
| Pharmaceuticals | ||||||
| Italy | 188,750 | 206,983 | 14,148 | 8,164 | 202,898 | 215,147 |
| France | 86,235 | 104,517 | 22,897 | 12,511 | 109,132 | 117,028 |
| Russia, Ukraine, other CIS | 66,719 | 81,955 | 2,370 | 1,634 | 69,089 | 83,589 |
| Germany | 87,495 | 91,464 | 13,100 | 10,001 | 100,595 | 101,465 |
| Spain | 54,414 | 62,826 | 8,665 | 6,594 | 63,079 | 69,420 |
| Turkey | 59,252 | 62,001 | 3,191 | 3,313 | 62,443 | 65,314 |
| Portugal | 31,313 | 31,999 | 1,244 | 980 | 32,557 | 32,979 |
| Other CEE | 62,018 | 57,246 | 5,080 | 2,771 | 67,098 | 60,017 |
| Other Western Europe | 46,268 | 40,892 | 20,596 | 14,999 | 66,864 | 55,891 |
| North Africa | 31,753 | 29,646 | 1,619 | 642 | 33,372 | 30,288 |
| Other international sales | 109,310 | 119,686 | 50,031 | 37,185 | 159,341 | 156,871 |
| U.S.A | ‐ | ‐ | 89,418 | 78,342 | 89,418 | 78,342 |
| Total pharmaceutical net | ||||||
| revenue | 823,527 | 889,215 | 232,359 | 117,136 | 1,055,886 | 1,066,351 |
| Pharmaceutical chemicals | ||||||
| Italy | 3,302 | 2,310 | ‐ | ‐ | 3,302 | 2,310 |
| Other European countries | 11,749 | 11,296 | ‐ | ‐ | 11,749 | 11,296 |
| U.S.A. | 4,225 | 6,495 | ‐ | ‐ | 4,225 | 6,495 |
| America (exc. U.S.A.) | 3,692 | 3,024 | ‐ | ‐ | 3,692 | 3,024 |
| Australasia | 13,844 | 10,059 | ‐ | ‐ | 13,844 | 10,059 |
| Africa | 1,120 | 883 | ‐ | ‐ | 1,120 | 883 |
| Total chemical | ||||||
| pharmaceuticals net | ||||||
| revenue | 37,932 | 34,067 | 0 | 0 | 37,932 | 34,067 |
| Total net revenue | 861,459 | 923,282 | 232,359 | 117,136 | 1,093,818 | 1,100,418 |
Overall operating expenses in the first nine months of 2020 are € 729.8 million, a decrease compared to the € 746.9 million in the same period of the preceding year and are analyzed by function as follows:
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
|---|---|---|---|
| Cost of sales | 308,237 | 329,069 | (20,832) |
| Selling expenses | 256,701 | 273,446 | (16,745) |
| Research and development expenses | 106,344 | 91,581 | 14,763 |
| General and administrative expenses | 53,644 | 51,740 | 1,904 |
| Other income (expense), net | 4,855 | 1,082 | 3,773 |
| Total operating expenses | 729,781 | 746,918 | (17,137) |
Cost of sales is € 308.2 or 28.2% of sales, a reduction compared to the 29.9% in the first nine months of 2019 due mainly to a larger proportion of products with higher margins.
Selling expenses decrease by 6.1% mainly due to the significant reduction of promotional activities as a result of the restrictions introduced in all markets to counter the COVID‐19 epidemiological emergency, with a consequent decrease as a percent of revenue compared to the same period of the preceding year.
Research and development expenses are € 106.3 million, up by 16.1% compared to those recorded in the first nine months of the preceding year due to the advancement of new development programs and the amortization of the rights to the new products Signifor® and Signifor® LAR and, as from the second quarter also Isturisa®, acquired from Novartis in October 2019. Before amortization charges research and development expenses grow by 3.6%.
General and administrative expenses are up by 3.7% while they remain substantially unchanged as percent of sales.
The main items in other (income) expense are summarized in the table below.
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
|---|---|---|---|
| Non‐recurring expenses | 5,182 | ‐ | 5,182 |
| Other | (327) | 1,082 | (1,409) |
| Total operating expenses | 4,855 | 1,082 | 3,773 |
Non‐recurring expenses are those related to the COVID‐19 epidemiological emergency, mainly donations to hospitals and healthcare services, but also include costs for the safety measures to secure workspaces and for the purchase of personal protective equipment.
Total operating expenses are analyzed by nature as follows:
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
|---|---|---|---|
| Material consumption | 231,297 | 258,032 | (26,735) |
| Payroll costs | 185,963 | 185,631 | 332 |
| Other employees' costs | 21,618 | 26,663 | (5,045) |
| Variable sales expenses | 61,767 | 56,888 | 4,879 |
| Depreciation and amortization | 69,582 | 56,112 | 13,470 |
| Utilities and consumables | 26,528 | 23,885 | 2,643 |
| Other expenses | 133,026 | 139,707 | (6,681) |
| Total operating expenses | 729,781 | 746,918 | (17,137) |
Material consumption as a percentage of sales is 21.1%, down by 2.3% compared to that in the same period of 2019.
Payroll costs include a cost for stock options of € 3.6 million in the first nine months of 2020 and € 5.3 million in the same period of the preceding year.
During the year 2019, some Group employees were designated as beneficiaries of an incentive plan, with a duration of 5 years, 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's duration. At 30 September 2020 recognition under IFRS 2 generated a cost booked to the profit and loss of € 0.8 million.
Total depreciation and amortization charges are € 69.6 million. Amortization charges are € 50.6 million, an increase of € 12.8 million over the same period of the preceding year mainly resulting from the acquisition of the rights to Signifor®, Signifor® LAR and Isturisa® from Novartis in October 2019. Depreciation charges are € 19.0 million, up by € 0.6 million compared to the first nine months of 2019.
In the first nine months of 2020 and in the same period of 2019 financial items record a net expense of € 11.2 million and € 16.0 million respectively and are comprised as follows:
| € (thousands) | First nine months 2020 |
First nine months 2019 |
Change 2020/2019 |
|---|---|---|---|
| Currency exchange (gains) losses | (600) | 893 | (1,493) |
| Interest expense on loans | 12,188 | 9,614 | 2,574 |
| Net interest (income) expense on short‐term | |||
| financial position | (1,282) | 4,221 | (5,503) |
| Interest cost on leases | 828 | 881 | (53) |
| Interest on tax assessments | ‐ | 222 | (222) |
| Interest cost in respect of defined benefit plans | 58 | 149 | (91) |
| Total financial income (expense), net | 11,192 | 15,980 | (4,788) |
The net increase of interest expense on loans is mainly due to the interest on the syndicated loan of € 400.0 million received by the Parent in June 2019 and the new loans granted by UBS Switzerland AG (75.0 million
Swiss francs to the Swiss subsidiary Recordati AG) and by UBI Banca (€ 40.0 million to the Parent), offset by lower interest charges on the \$ 70 million loan privately placed by the US subsidiary Recordati Rare Diseases Inc. in 2013 and reimbursed in advance in the first part of 2019, as well as by more favourable variable interest rates on the IFC‐World Bank loan.
During the period the Parent company repaid in advance to the U.S. company Recordati Rare Diseases Inc. two loans stipulated in November 2016 for an overall amount of \$ 70 million (which correspond to the two tranches of the notes privately placed by the US subsidiary in 2013) and extinguished the relative cross‐currency swaps. Following the early reimbursement of the notes in the first half of 2019, the derivative financial instruments no longer qualified as hedging instruments and their change in fair value was recognized to the profit and loss, net of the effect of the conversion of the loans to the current Euro/Dollar exchange rate. The settlement of the cross‐currency swaps gave rise to a gain, net of the currency exchange loss associated with the reimbursement of the intercompany loans and bank charges, of € 2.6 million, compared to net charges of € 1.1 million in the first nine months of the preceding year.
The provision for taxes amounts to € 78.7 million and includes income taxes levied on all consolidated companies as well as the Italian regional tax on production activities (IRAP) which is levied on all Italian companies.
Following the agreement reached with 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 period 2015 to 2019, the Parent Company decided to adhere – instead of renewing the agreement – to the new optional reverse charge mechanism provided for by art. 4 of the 30 April 2019 legislative decree number 34, and therefore determine directly in its tax returns the discount on taxable income provided by the "patent box" for the current year, using the same criteria agreed with the tax authorities for the preceding five‐year period and providing documentation supporting the calculation. The accrued benefit for the first nine months 2020, booked as a reduction in taxes, is € 6.4 million.
The composition and variation of property, plant and equipment, including the valuation of the right to use the assets conveyed under leases, are shown in the following table:
| € (thousands) | Land & buildings |
Plant & machinery |
Other equipment |
Advances/ construction in progress |
Total |
|---|---|---|---|---|---|
| Cost | |||||
| Balance at 31 December 2019 | 92,762 | 233,176 | 92,182 | 19,596 | 437,716 |
| Additions | 3,776 | 2,354 | 8,743 | 8,447 | 23,320 |
| Disposals | (2,451) | (318) | (3,896) | 0 | (6,665) |
| Other changes | (3,427) | 2,303 | (410) | (7,831) | (9,365) |
| Balance at 30 September 2020 | 90,660 | 237,515 | 96,619 | 20,212 | 445,006 |
| Accumulated depreciation | |||||
| Balance at 31 December 2019 | 48,016 | 193,906 | 62,452 | 0 | 304,374 |
| Depreciation for the period | 4,506 | 6,324 | 8,145 | 0 | 18,975 |
| Disposals | (1,448) | (372) | (2,930) | 0 | (4,750) |
| Other changes | (624) | (1,573) | (1,135) | 0 | (3,332) |
| Balance at 30 September 2020 | 50,450 | 198,285 | 66,532 | 0 | 315,267 |
| Carrying amount at | |||||
| 31 December 2019 | 44,746 | 39,270 | 29,730 | 19,596 | 133,342 |
| 30 September 2020 | 40,210 | 39,230 | 30,087 | 20,212 | 129,739 |
The additions during the period are € 23.3 million, of which € 10.1 million related to the right to use the assets conveyed under leases, and refer mainly to investments by the Parent (€ 8.9 million), the Turkish subsidiary Recordati Ilaç (€ 2.9 million), the Portuguese subsidiary Jaba Recordati (€ 2.2 million) and the Spanish subsidiary Casen Recordati (€ 1.7 million).
Disposals are mainly due to the expiry of the rights of use of land and buildings, plant and machinery and other equipment conveyed under leases.
The line "Other changes" includes the conversion into euros of the tangible assets booked in different currencies, for a net decrease of € 6.0 million compared to that at 31 December 2019, of which € 5.3 million due to the devaluation of the Turkish lira.
The following table shows the valuation of the right to use the assets conveyed under leases, already included in the table above, determined as prescribed by IFRS 16.
| € (thousands) | Land and buildings |
Plant and machinery |
Other equipment |
Total |
|---|---|---|---|---|
| Cost | ||||
| Balance at 31 December 2019 | 20,239 | 496 | 17,263 | 37,998 |
| Additions | 2,962 | 858 | 6,325 | 10,145 |
| Disposals | (1,860) | (289) | (3,421) | (5,570) |
| Other changes | (668) | 17 | (1,450) | (2,101) |
| Balance at 30 September 2020 | 20,673 | 1,082 | 18,717 | 40,472 |
| Accumulated depreciation | ||||
| Balance at 31 December 2019 | 4,196 | 247 | 5,804 | 10,247 |
| Depreciation for the period | 2,837 | 176 | 4,662 | 7,675 |
| Disposals | (879) | (289) | (2,473) | (3,641) |
| Other changes | (205) | 2 | (557) | (760) |
| Balance at 30 September 2020 | 5,949 | 136 | 7,436 | 13,521 |
| Carrying amount at | ||||
| 31 December 2019 | 16,043 | 249 | 11,459 | 27,751 |
| 30 September 2020 | 14,724 | 946 | 11,281 | 26,951 |
Right‐of‐use assets refer mainly to the office premises of several Group subsidiaries and of the cars used by medical representatives operating in their territories.
The composition and variation of intangible assets are shown in the following table:
| € (thousands) | Patent rights and marketing authorizations |
Distribution, license, trademark and similar rights |
Other | Advance payments |
Total |
|---|---|---|---|---|---|
| Cost | |||||
| Balance at 31 December 2019 | 801,402 | 502,530 | 21,764 | 263,559 | 1,589,255 |
| Additions | 164 | 324 | 210 | 19,893 | 20,591 |
| Disposals | 0 | 0 | (14) | (48) | (62) |
| Other changes | 223,433 | (389) | (309) (234,978) | (12,243) | |
| Balance at 30 September 2020 | 1,024,999 | 502,465 | 21,651 | 48,426 | 1,597,541 |
| Accumulated amortization | |||||
| Balance at 31 December 2019 | 217,723 | 190,368 | 19,404 | 0 | 427,495 |
| Amortization for the period | 31,162 | 19,091 | 354 | 0 | 50,607 |
| Disposals | 0 | 0 | (5) | 0 | (5) |
| Other changes | (5,207) | (655) | (228) | 0 | (6,090) |
| Balance at 30 September 2020 | 243,678 | 208,804 | 19,525 | 0 | 472,007 |
| Carrying amount at | |||||
| 31 December 2019 | 583,679 | 312,162 | 2,360 | 263,559 | 1,161,760 |
| 30 September 2020 | 781,321 | 293,661 | 2,126 | 48,426 | 1,125,534 |
Additions during the period are mainly attributable to the recent license agreement with ARS Pharmaceuticals covering the rights to ARS‐1 a nasal spray containing epinephrine in advanced development for the emergency treatment of severe allergic reactions, and to other conditions covered by the agreements with Novartis for
the rights to Signifor®, Signifor® LAR and Isturisa® and with Gedeon Richter for the rights to Reagila®.
The conversion into euros of the intangible assets booked in different currencies, included in the line "Other changes", gives rise to a net decrease of € 6.2 million as compared to 31 December 2019, mainly attributable to the devaluation of the U.S. dollar for an amount of € 3.0 million, the devaluation of the Russian ruble for an amount of € 4.4 million, the devaluation of the Turkish lira for an amount of € 1.0 million and the revaluation of the Swiss franc for an amount of € 2.6 million.
Net goodwill at 30 September 2020 amounts to € 562.0 million, a decrease of € 16.0 million as compared to that at 31 December 2019, 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 euros at the period‐end exchange rate. Conversion at 30 September 2020 resulted in an overall net decrease of € 16.0 million, compared to that at 31 December 2019, to be attributed to the acquisitions in Turkey (decrease of € 9.9 million), Russia (decrease of € 3.7 million), Poland (decrease of € 1.0 million), Czech Republic (decrease of € 1.0 million), Tunisia (decrease of € 0.5 million) and Switzerland (increase of € 0.1 million).
In compliance with IFRS 3 goodwill is not systematically amortized. Instead, it is tested for impairment on an annual basis or more frequently if specific events or circumstances indicate a possible loss of value. During the period, no events or circumstances arose to indicate possible value loss related to any of the abovementioned items.
At 30 September 2020 other investments amount to € 28.9 million, a decrease of € 9.6 million compared to those at 31 December 2019.
The main investment is that made in the U.K. company PureTech Health plc, specialized in investment in start‐ up companies dedicated to innovative therapies, medical devices and new research technologies. Starting 19 June 2015, the shares of the company were admitted to trading on the London Stock Exchange. At 30 September 2020, the overall listed value of the 9.554.140 shares held is of € 26.7 million. The € 8.9 million
decrease in value compared to that at 31 December 2019 is recognized directly in equity, net of the relative tax effect, and shown on the statement of comprehensive income.
This account also comprises € 2.2 million regarding an investment made during 2012 in Erytech Pharma S.A., a listed late development stage French biopharmaceutical company focused on orphan oncology and rare diseases. The investment, originally structured as a non‐interest‐bearing loan, was converted into 431,034 shares of the company in May 2013. As compared to 31 December 2019 the value of the investment was reduced by € 0.7 million to bring it in line with its listed value. This amount, net of its tax effect, is recognized directly in equity and shown on the statement of comprehensive income.
Other non‐current assets at 30 September 2020 are € 6.7 million, a reduction of € 9.7 million compared to those at 31 December 2019 mainly due to the reclassification to other current assets of the tax benefit obtained under the so‐called "patent box" agreed with the Italian tax authorities in December 2019 to be utilized as from 2021.
At 30 September 2020 deferred tax assets are € 78.1 million, a net increase of € 6.6 million compared to those at 31 December 2019. The effect of deferred tax assets related to components of the other comprehensive income is a net decrease of € 0.4 million.
Inventories are € 250.3 million, an increase of € 23.4 million compared to those stated at 31 December 2019 and include, among others, supplies of Signifor®, Signifor® LAR and Isturisa® in view of their direct distribution.
Trade receivables at 30 September 2020 are € 270.0 million, a decrease of € 27.0 million compared to that at 31 December 2019 due to the decrease in sales during the second and third quarters of 2020 because of the COVID‐19 epidemiological emergency. Trade receivables are stated net of a € 14.3 million provision for doubtful accounts, a decrease of € 0.6 million compared to 31 December 2019, booked to the P&L under selling expenses, which reflects the potential collection risk connected with certain customers and geographic areas. Days sales outstanding are 69, higher than the 63 registered at 31 December 2019 but in line with the 67 reported at 30 September 2019.
Other receivables, at € 57.1 million, decrease by € 22.8 million compared to those at 31 December 2019, mainly due to the Parent's lower tax credits following the accrual of tax payable for the period. The so‐called patent box tax credits are accounted for here and include € 9.7 million reclassified from non‐current assets as they can be used in 2021.
Other current assets are € 13.6 million and refer mainly to prepaid expenses.
The cross currency swaps covering the cash flows related to the notes issued and privately placed on 30 September 2014, for an amount of \$ 75 million, measured at fair value at 30 September 2020 give rise to a € 10.1 million asset recognized under current assets as 'Fair value of hedging derivatives (cash flow hedge)'. This amount represents the potential benefit of a lower value in euros of the future dollar denominated capital and
interest flows, in view of the revaluation of the foreign currency subsequent to the moment in which the loan and hedging instrument were negotiated. In particular, the change in fair value of the hedging instrument covering the \$ 50 million tranche of the loan, provided by Mediobanca, was positive for an amount of € 6.6 million, and that covering the \$ 25 million tranche of the loan, provided by UniCredit, yielded a € 3.5 million positive value change.
During the first nine months of 2020 other foreign currency hedging instruments were put in place. Their fair value measurement at 30 September 2020 resulted in a positive change of € 0.4 million, booked to profit and loss to offset the exchange rate losses incurred following the conversion of the underlying instruments at current rates.
The fair value of such hedging derivatives is measured at level 2. The fair value is calculated as the present 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 these purposes when pricing interest rate swaps.
Short term financial investments, cash and cash equivalents at 30 September 2020 are € 277.6 million, an increase of € 89.7 million compared to those at 31 December 2019 and are mostly denominated in euros, U.S. dollars and Pounds Sterling and comprise mainly current accounts and short‐term deposits.
Shareholders' Equity at 30 September 2020 is € 1,287.6 million, an increase of € 88.8 million compared to that at 31 December 2019 for the following combined reasons:
The Italian company Recordati Rare Diseases Italy is 99% owned giving rise to a minority interest of € 271.0 thousand.
As at 30 September 2020 the Company has three stock option plans in favor of certain group employees in place, the 2010‐2013 plan, under which options were granted on 8 May 2012, on 17 April 2013 and on 30 October 2013, the 2014‐2018, plan under which options were granted on 29 July 2014 and on 13 April 2016 and the 2018‐2022 plan, under which options were granted on 3 August 2018. The strike price of the options is the average of the parent company's listed share price during the 30 days prior to the grant date. Stock
options are vested over a period of five years and those not exercised within the eighth year of the date of grant expire. Options cannot be exercised if the employee leaves the company before they are vested. Stock options outstanding at 30 September 2020 are analyzed in the following table.
| Strike price (€) |
Options outstanding at 1.1.2020 |
Options granted during 2020 |
Options exercised during 2020 |
Options cancelled or expired |
Options outstanding at 30.9.2020 |
|
|---|---|---|---|---|---|---|
| Date of grant | ||||||
| 8 May 2012 | 5.3070 | 242,500 | ‐ | (216,000) | ‐ | 26,500 |
| 17 April 2013 | 7.1600 | 25,000 | ‐ | (25,000) | ‐ | ‐ |
| 30 October 2013 | 8.9300 | 5,000 | ‐ | (5,000) | ‐ | ‐ |
| 29 July 2014 | 12.2900 | 1,138,500 | ‐ | (360,000) | ‐ | 778,500 |
| 13 April 2016 | 21.9300 | 2,218,000 | ‐ | (494,000) | (40,500) | 1,683,500 |
| 3 August 2018 | 30.7300 | 4,578,500 | ‐ | (508,000) | (131,000) | 3,939,500 |
| Total | 8,207,500 | ‐ | (1,608,000) | (171,500) | 6,428,000 |
At 30 September 2020, 2,983,802 own shares are held as treasury stock, a decrease of 324,769 shares as compared to those at 31 December 2019. The change is to be attributed to the disposal of 1,608,000 shares, for an overall value of € 32.2 million, to service the exercise of stock options issued under the stock option plans and to the purchase of 1,283,231 shares for an overall value of € 47.9 million. The overall purchase cost of the shares held in treasury stock is € 92.3 million with an average unit price of € 30.93.
During the year 2019, some Group employees were designated as beneficiaries of an incentive plan, for a duration of 5 years, 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's duration.
At 30 September 2020 loans total € 1,118.9 million, a net increase of € 31.8 million compared to those at 31 December 2019.
Loans include the liability, determined by the application of the accounting principle IFRS 16, that represents the obligation of making the payments provided for in the existing lease contracts for an overall value of € 27.2 million, a net decrease of € 0.5 million compared to that at 31 December 2019.
During the first nine months 2020 loans increased by € 120.3 million, € 110.2 million from the raising of new loans and € 10.1 million attributable to new leasing contracts, while a total of € 80.6 million was reimbursed, of which € 7.2 million related to leasing liabilities. The loan from ING Bank for an amount of € 30.0 million, originally undersigned by the Parent company on 8 January 2014 and re‐negotiated on 12 June 2015 with only the interest rate being changed, has been entirely reimbursed following the payment of the last installment in January. The relative interest rate swap was extinguished. The loan stipulated by the Parent with UniCredit in May 2015 for an amount of € 50.0 million was extinguished following the payment of the last installment in May.
The conversion of loans in currencies other than the Euro together with the early termination of various leasing contracts, determined a net decrease of € 7.9 million compared to those at 31 December 2019.
The average effective interest rate at 30 September 2020, applying the rates resulting from the hedging instruments, is 1.51%.
The main loans outstanding are:
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
e) A loan agreement undersigned with Mediobanca by the Parent in November 2018 for an amount of € 150.0 million. The main terms and conditions provide for variable interest rate fixed at the six months' Euribor
plus a variable spread, that may change through a step up/step down mechanism linked to the Leverage Ratio, with semi‐annual repayments of principal from 23 November 2020 through 22 November 2023. The loan is entirely covered with an interest rate swap, qualifying as a cash flow hedge, effectively converting the interest charges from variable to a fixed rate. The measurement at fair value at 30 September 2020 of the swap generated a liability of € 2.2 million which is recognized directly as a decrease in equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current liabilities (see Note 22). The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants, measured annually, are the following:
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
l) Privately placed guaranteed senior notes by the Parent 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 notes includes covenants which, if not met, could lead to a
request for immediate repayment of the loan. The financial covenants, measured quarterly, are the following:
The above conditions were fulfilled during the period.
The above conditions are fulfilled.
The above conditions are fulfilled.
o) A loan agreement with IFC‐World Bank undersigned by the subsidiary Recordati Ilaç on 16 October 2014 for an amount of 71.6 million Turkish lira to finance the construction of a new production plant. Main terms are: variable interest rate equivalent to the 3 months' Trlibor plus a fixed spread, 8‐year duration and reimbursement of principal at the end of every three months starting November 2016 through August 2022. The value in euros of the outstanding loan at 30 September 2020 is of € 2.5 million, resulting in a reduction of the liability by € 2.2 million as compared to that at 31 December 2019, of which € 1.1 million was due to the devaluation of the Turkish lira at the date of consolidation. The loan agreement includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants, measured quarterly, are:
The above conditions were fulfilled.
p) Privately placed guaranteed senior notes by the Parent company on 30 September 2014 for an amount of \$ 75 million in two tranches: \$ 50 million at a fixed interest rate to be reimbursed bi‐annually as from 30 March 2022 through 30 September 2026, and \$ 25 million at a fixed interest rate to be reimbursed bi‐ annually as from 30 March 2023 through 30 September 2029. The conversion of the loan into euros at 30 September 2020 resulted in a decrease of the liability by € 2.7 million as compared to that at 31 December 2019 due to the devaluation of the U.S. dollar. The loan was simultaneously covered with two currency rate swaps transforming the overall debt to € 56.0 million, of which € 37.3 million at a lower fixed interest rate on the 12‐year tranche and € 18.7 million at a lower fixed interest rate on the 15‐year tranche. At 30 September 2020 the measurement at fair value of the hedging instruments generated an overall positive amount of € 10.1 million recognized directly to equity and stated as an increase of the 'Fair value of hedging derivatives (cash flow hedge)' under current assets (see Note 14).
The note purchase agreement covering the senior guaranteed notes issued by Recordati S.p.A. includes covenants which, if not met, could lead to a request for immediate repayment of the loan. The financial covenants, measured quarterly, are the following:
The above conditions were fulfilled during the period.
The above conditions were fulfilled during the period.
The staff leaving indemnity fund at 30 September 2020 is of € 20.1 million and is measured as prescribed by IAS 19.
Deferred tax liabilities at 30 September 2020 are € 41.3 million, a decrease of € 1.9 million as compared to those at 31 December 2019.
Other non‐current liabilities at 30 September 2020 are € 20.3 million. They include € 17.0 million relative to future milestones due to Novartis AG upon the launch of Isturisa® in selected European markets and € 3.3 million relative to the debt for the acquisition of a further 10% of the share capital of Opalia Pharma which, in line with the put and call options in the purchase agreement, is expected to be settled not before the next 12 months. The fair value of such purchase option is measured at level 2 as the valuation model considers the present value of expected payments.
Trade payables, which include the accrual for invoices to be received, are € 145.2 million.
Other payables are € 87.8 million, a decrease of € 97.9 million compared to those at 31 December 2019, and relate mainly to:
the price to the public before VAT of pharmaceutical products reimbursed by the National Health Service. The reduction compared to 31 December 2019 is mainly attributable to the payment of \$ 20.0 million upon the approval, in January 2020, of Isturisa® in Europe, \$ 60 million upon approval, in March 2020, of the product in the U.S.A. and \$ 10 million following the advancement of the launch in Europe.
Tax payables are € 37.1 million, an increase of € 16.0 million compared to those at 31 December 2019.
Other current liabilities are € 11.3 million, a reduction of € 1.2 million as compared to those at 31 December 2019. An amount of € 10.0 million is attributable to the effect of the application of IFRS 15. This liability is released to the profit and loss in variable quotas as revenue recognition conditions are met.
Provisions are € 16.2 million, a reduction of € 1.7 million compared to those at 31 December 2019.
The measurement at fair value of the interest rate swaps covering the cash flows related to loans gave rise to a net € 6.0 million liability at 30 September 2020 recognized under current liabilities as 'Fair value of hedging derivatives (cash flow hedge)'. This amount represents the unrealized opportunity of paying the current
expected future rates instead of the rates agreed. The amount refers to the interest rate swaps to cover the interest rate risk associated with the loans granted by Mediobanca (€ 3.1 million), Intesa Sanpaolo (€ 1.4 million), UBI Banca (€ 0.7 million), Centrobanca (€ 0.5 million) and UniCredit (€ 0.3 million).
In October 2019 Recordati S.p.A. stipulated forward exchange contracts to cover the intercompany loan granted to Recordati AG for an amount of 228.9 million Swiss francs. The fair value of the derivative at 30 September 2020 on the residual loan of 213.5 million Swiss francs was negative by € 3.6 million, which were booked to profit and loss compensating the exchange gains determined by the valuation of the underlying loan at current exchange rates.
During the first nine months 2020 hedging derivatives to cover foreign currency positions were put in place. Their fair value at 30 September 2020 was negative by € 0.1 million, which were booked to profit and loss compensating the exchange gains determined by the valuation of the underlying loan at current exchange rates.
The fair value of such hedging derivatives is measured at level 2. The fair value is calculated as the present 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 constructed from similar sources and which reflects the relevant benchmark interbank rate used by market participants for this purpose when pricing interest rate swaps.
Bank overdrafts and short‐term loans are € 14.7 million at 30 September 2020 and are comprised mainly of temporary use of lines of credit, current account overdrafts and interest accrued 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 and reporting standards used for the preparation and disclosure of the Group consolidated financial statements. Two main business segments can be identified, the specialty and primary care segment and the rare diseases segment.
The following tables show financial information for these two business segments as at 30 September 2020 and includes comparative data.
| € (thousands) | Specialty & primary care segment* |
Rare diseases segment |
Non‐allocated | Consolidated accounts |
|---|---|---|---|---|
| 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 |
| First nine months 2019 | ||||
| Net revenue | 923,282 | 177,136 | ‐ | 1,100,418 |
| Expenses | (650,382) | (96,536) | ‐ | (746,918) |
| Operating income | 272,900 | 80,600 | ‐ | 353,500 |
* Includes the pharmaceutical chemicals operations
| € (thousands) | Specialty & primary care segment* |
Rare diseases segment |
Non‐allocated ** |
Consolidated accounts |
|---|---|---|---|---|
| 30 September 2020 | ||||
| Non‐current assets | 1,160,691 | 741,361 | 28,933 | 1,930,985 |
| Inventories | 211,922 | 38,412 | ‐ | 250,334 |
| Trade receivables | 198,716 | 71,266 | ‐ | 269,982 |
| Other current assets | 56,903 | 13,855 | 10,465 | 81,223 |
| Short‐term investments, cash and | ||||
| cash equivalents | ‐ | ‐ | 277,622 | 277,622 |
| Total assets | 1,628,232 | 864,894 | 317,020 | 2,810,146 |
| Non‐current liabilities | 61,159 | 20,552 | 898,967 | 980,678 |
| Current liabilities | 216,907 | 80,613 | 244,373 | 541,893 |
| Total liabilities | 278,066 | 101,165 | 1,143,340 | 1,522,571 |
| Net capital employed | 1,350,166 | 763,729 | ||
| 31 December 2019 | ||||
| Non‐current assets | 1,213,146 | 747,868 | 38.566 | 1,999,580 |
| Inventories | 200,848 | 26,037 | ‐ | 226,885 |
| Trade receivables | 234,788 | 62,173 | ‐ | 296,961 |
| Other current assets | 76,352 | 11,280 | 9,949 | 97,581 |
| Short‐term investments, cash and | ||||
| cash equivalents | ‐ | ‐ | 187,923 | 187,923 |
| Total assets | 1,725,134 | 847,358 | 236,438 | 2,808,930 |
| Non‐current liabilities | 63,441 | 22,581 | 937,343 | 1,023,365 |
| Current liabilities | 265,343 | 147,414 | 173,997 | 586,754 |
| Total liabilities | 328,784 | 169,995 | 1,111,340 | 1,610,119 |
* Includes the pharmaceutical chemicals operations.
** Non‐allocated amounts include: other equity investments, short‐term investments, cash and cash equivalents, loans, hedging instruments, bank overdrafts and short‐term loans.
The pharmaceutical chemicals operations are considered part of the specialty and primary care segment as they are prevalently dedicated to the production of active ingredients for this business, both from a strategic and organizational point of view.
The parent company and some subsidiaries are party to certain minor legal actions, the outcomes of which are not expected to result in any significant liability. Some license agreements provide for future milestones which to date are not deemed probable and therefore merely potential. Among these the only ones for a potentially material amount are for a total of around € 35 million.
The Group's direct controlling company is FIMEI S.p.A., headquartered in Milan, via Vecchio Politecnico 9, Italy which since 2018 is owned by a consortium of investors controlled by CVC Capital Partners.
Tax credits shown in the consolidated balance sheet at 30 September 2020 include those receivable from the direct controlling company FIMEI S.p.A. for an amount of € 14.7 million. This amount refers to tax liabilities computed by the parent Recordati S.p.A. based on estimated taxable income and transferred to the direct controlling company consequent to the participation in a tax consolidation grouping under tax laws in Italy. The amount includes the effect of the so‐called "patent box" for the part related to corporate tax both for the 2015‐2019 period following the agreement with the Italian tax authorities in December 2019, as well as for the first nine months 2020.
Except for the above, to our knowledge, no transactions or contracts have been entered into with related parties that can be considered significant, in value or conditions, or which could in any way materially affect the accounts.
At the date of preparation of the financial statements no significant events occurred subsequent to the closing of the period that would require changes to the values of assets, liabilities or the profit and loss.
On October 1st, 2020 the Company's Board of Directors approved the reverse merger by incorporation of Rossini Investimenti S.p.A. and FIMEI S.p.A. in Recordati S.p.A. (the "Transaction" or the "Merger") and the documentation preparatory to implementation of the Merger, including the relevant merger plan, which is available on the Company's website (www.recordati.com, under "Investors"/"Shareholders' Meetings/Reverse merger into Recordati S.p.A. 2020‐2021") for further information.
The Merger, that is part of the overall process for the indirect acquisition of Recordati S.p.A. by Rossini Investimenti S.p.A., achieved through the acquisition of the entire share capital of FIMEI S.p.A. (to which it is closely and intrinsically connected), aims to achieve a shortening the chain of control with respect to the operating companies, obtaining, for the benefit of the majority shareholders and the entire Group, a simplification of the Group's corporate structure and the reduction of administrative costs associated with maintaining the companies to be incorporated (Rossini Investimenti S.p.A. and FIMEI S.p.A.) and, for the incorporating company (Recordati S.p.A.), lower taxes due to transfer of tax incentives from Rossini Investimenti, subject to Italian tax ruling.
It should be noted that the Merger will not entail any change to the share capital of the incorporating company nor is any balancing cash payment planned. Furthermore, the balance sheet and earnings profile of the entity resulting from the Merger will be substantially in line with that of the incorporating company at present and, in particular, the Merger will not alter the net financial position and, therefore, the investment capacity of Recordati or the strategy or its capital allocation policy.
The Merger constitutes a "major" related party transaction, in accordance with the regulation adopted by Consob under resolution no. 17221 of 12 March 2010 and subsequent modifications and with the current Procedure governing operations with related parties. As such, the operation, in its entirety, received the favourable opinion of Recordati's Control, Risk and Sustainability Committee acting as the Related Party Transactions Committee (the "Committee"), pursuant to the regulations governing Related Party Transactions.
The Information Document related to major related party transactions, approved by the Board of Directors on the 1st of October 2020 and prepared to illustrate the Operation, together with the Committee's fairness opinion (which includes the fairness opinion on the exchange ratio issued by Prof. Pietro Mazzola as independent financial advisor to the Committee) is also available con the abovementioned Recordati website.
It is envisaged that the Merger shall be completed by the end of the first half of 2021 and in any event following the date of approval of the financial statements of the Companies to be incorporated as at 31 December 2020 and of their closing balance sheets as at 31 March 2021.
Italy and all the main countries in which the Group operates continue to be impacted by restrictions to the circulation of people and provisions to support companies' economic activities have been introduced following the epidemiologic emergency due to the COVID‐19 virus, declared a pandemic by the OMS in March. To face the emergency, in Italy, and subsequently also in other countries the Group has implemented all possible measures and initiatives to guarantee the supply of medicines to its patients and the safety of its employees. The first nine months results show that the impact on the Group's consolidated revenues is more than offset by the positive contribution from new products and the containment of operating expenses resulting from reduced activities, with operating and net income remaining in line with expectations.
| Consolidated Companies | Head Office | Share Capital | Currency | Consolidation Method |
|---|---|---|---|---|
| RECORDATI S.P.A. Development, production, marketing and sales of pharmaceuticals and pharmaceutical chemicals |
Italy | 26,140,644.50 | EUR | Line‐by‐line |
| INNOVA PHARMA S.P.A. Marketing and sales of pharmaceuticals |
Italy | 1,920,000.00 | EUR | Line‐by‐line |
| CASEN RECORDATI S.L. Development, production, marketing and sales of pharmaceuticals |
Spain | 238,966,000.00 | EUR | Line‐by‐line |
| BOUCHARA RECORDATI S.A.S. Development, production, marketing and sales of pharmaceuticals |
France | 4,600,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES COMERCIO DE MEDICAMENTOS LTDA Holds pharmaceutical marketing rights in Brazil |
Brazil | 166.00 | BRL | Line‐by‐line |
| RECORDATI RARE DISEASES INC. Development, production, marketing and sales of pharmaceuticals |
U.S.A. | 11,979,138.00 | USD | Line‐by‐line |
| RECORDATI IRELAND LTD Development, production, marketing and sales of pharmaceuticals |
Ireland | 200,000.00 | EUR | Line‐by‐line |
| LABORATOIRES BOUCHARA RECORDATI S.A.S. Development, production, marketing and sales of pharmaceuticals |
France | 14,000,000.00 | EUR | Line‐by‐line |
| RECORDATI PHARMA GmbH Marketing and sales of pharmaceuticals |
Germany | 600,000.00 | EUR | Line‐by‐line |
| RECORDATI PHARMACEUTICALS LTD Marketing and sales of pharmaceuticals |
United Kingdom | 15,000,000.00 | GBP | Line‐by‐line |
| RECORDATI HELLAS PHARMACEUTICALS S.A. Marketing and sales of pharmaceuticals |
Greece | 10,050,000.00 | EUR | Line‐by‐line |
| JABA RECORDATI S.A. Marketing and sales of pharmaceuticals |
Portugal | 2,000,000.00 | EUR | Line‐by‐line |
| JABAFARMA PRODUTOS FARMACÊUTICOS S.A. Marketing of pharmaceuticals |
Portugal | 50,000.00 | EUR | Line‐by‐line |
| BONAFARMA PRODUTOS FARMACÊUTICOS S.A. Marketing of pharmaceuticals |
Portugal | 50,000.00 | EUR | Line‐by‐line |
| RECORDATI ORPHAN DRUGS S.A.S. Holding company |
France | 57,000,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES MIDDLE EAST FZ LLC Marketing and sales of pharmaceuticals |
United Arab Emirates |
100,000.00 | AED | Line‐by‐line |
| RECORDATI AB Marketing and sales of pharmaceuticals |
Sweden | 100,000.00 | SEK | Line‐by‐line |
| RECORDATI RARE DISEASES S.à r.l. Development, production, marketing and sales of pharmaceuticals |
France | 320,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES UK Limited Marketing and sales of pharmaceuticals |
United Kingdom | 50,000.00 | GBP | Line‐by‐line |
| RECORDATI RARE DISEASES GERMANY GmbH Marketing and sales of pharmaceuticals |
Germany | 25,600.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES SPAIN S.L. Marketing and sales of pharmaceuticals |
Spain | 1,775,065.49 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES ITALY S.R.L. Marketing and sales of pharmaceuticals |
Italy | 40,000.00 | EUR | Line‐by‐line |
| RECORDATI BVBA Marketing and sales of pharmaceuticals |
Belgium | 18,600.00 | EUR | Line‐by‐line |
| FIC MEDICAL S.à r.l. Marketing of pharmaceuticals |
France | 173,700.00 | EUR | Line‐by‐line |
| HERBACOS RECORDATI s.r.o. Development, production, marketing and sales of pharmaceuticals |
Czech Republic | 25,600,000.00 | CZK | Line‐by‐line |
| RECORDATI SK s.r.o. Marketing and sales of pharmaceuticals |
Slovakia | 33,193.92 | EUR | Line‐by‐line |
| Consolidated Companies | Head Office | Share Capital | Currency | Consolidation Method |
|---|---|---|---|---|
| RUSFIC LLC Marketing and sales of pharmaceuticals |
Russian Federation | 3,560,000.00 | RUB | Line‐by‐line |
| RECOFARMA ILAÇ Ve Hammaddeleri Sanayi Ve Ticaret L.Ş. Marketing of pharmaceuticals |
Turkey | 10,000.00 | TRY | Line‐by‐line |
| RECORDATI ROMÂNIA S.R.L. Marketing and sales of pharmaceuticals |
Romania | 5,000,000.00 | RON | Line‐by‐line |
| RECORDATI İLAÇ Sanayi Ve Ticaret A.Ş. Development, production, marketing and sales of pharmaceuticals |
Turkey | 180,000,000.00 | TRY | Line‐by‐line |
| RECORDATI POLSKA Sp. z o.o. Marketing and sales of pharmaceuticals |
Poland | 4,500,000.00 | PLN | Line‐by‐line |
| ACCENT LLC Holds pharmaceutical marketing rights |
Russian Federation | 20,000.00 | RUB | Line‐by‐line |
| RECORDATI UKRAINE LLC Marketing of pharmaceuticals |
Ukraine | 1,031,896.30 | UAH | Line‐by‐line |
| CASEN RECORDATI PORTUGAL Unipessoal Lda Marketing and sales of pharmaceuticals |
Portugal | 100,000.00 | EUR | Line‐by‐line |
| OPALIA PHARMA S.A. Development, production, marketing and sales of pharmaceuticals |
Tunisia | 9,656,000.00 | TND | Line‐by‐line |
| OPALIA RECORDATI S.à r.l. Marketing of pharmaceuticals |
Tunisia | 20,000.00 | TND | Line‐by‐line |
| RECORDATI RARE DISEASES S.A. DE C.V. Marketing of pharmaceuticals |
Mexico | 16,250,000.00 | MXN | Line‐by‐line |
| RECORDATI RARE DISEASES COLOMBIA S.A.S Marketing of pharmaceuticals |
Colombia | 150,000,000.00 | COP | Line‐by‐line |
| ITALCHIMICI S.p.A. Marketing of pharmaceuticals |
Italy | 7,646,000.00 | EUR | Line‐by‐line |
| RECORDATI AG Marketing of pharmaceuticals |
Switzerland | 15,000,000.00 | CHF | Line‐by‐line |
| PRO FARMA GmbH Marketing of pharmaceuticals |
Austria | 35,000.00 | EUR | Line‐by‐line |
| RECORDATI RARE DISEASES CANADA Inc. Marketing of pharmaceuticals |
Canada | 350,000.00 | CAD | Line‐by‐line |
| RECORDATI RARE DISEASES JAPAN K.K. 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 (1) Marketing of pharmaceuticals |
Bulgaria | 50,000.00 | BGN | Line‐by‐line |
(1) Established in 2019
| PERCENTAGE OF OWNERSHIP | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Consolidated companies | Recordati S.p.A. (Parent) |
Recordati Pharma GmbH |
Bouchara Recordati S.A.S. |
Casen Recordati S.L. |
Recordati Orphan Drugs S.A.S. |
Recordati Rare Diseases S.à r.l. |
Herbacos Recordati s.r.o. |
Recordati Ilaç A.Ş. |
Opalia Pharma S.A. |
Recordati AG |
Total |
| INNOVA PHARMA S.P.A. | 100.00 | 100.00 | |||||||||
| CASEN RECORDATI S.L. | 100.00 | 100.00 | |||||||||
| BOUCHARA RECORDATI S.A.S. | 100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES COMERCIO DE MEDICAMENTOS LTDA |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES INC. | 100.00 | 100.00 | |||||||||
| RECORDATI IRELAND LTD | 100.00 | 100.00 | |||||||||
| LABORATOIRES BOUCHARA RECORDATI S.A.S. |
100.00 | 100.00 | |||||||||
| RECORDATI PHARMA GmbH | 55.00 | 45.00 | 100.00 | ||||||||
| RECORDATI PHARMACEUTICALS LTD |
100.00 | 100.00 | |||||||||
| RECORDATI HELLAS PHARMACEUTICALS S.A. |
100.00 | 100.00 | |||||||||
| JABA RECORDATI S.A. | 100.00 | 100.00 | |||||||||
| JABAFARMA PRODUTOS FARMACÊUTICOS S.A. |
100.00 | 100.00 | |||||||||
| BONAFARMA PRODUTOS FARMACÊUTICOS S.A. |
100.00 | 100.00 | |||||||||
| RECORDATI ORPHAN DRUGS S.A.S. |
90.00 | 10.00 | 100.00 | ||||||||
| RECORDATI RARE DISEASES MIDDLE EAST FZ LLC |
100.00 | 100.00 | |||||||||
| RECORDATI AB | 100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES S.à r.l. |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES UK LIMITED |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES GERMANY GmbH |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES SPAIN S.L. |
100.00 | 100.00 | |||||||||
| RECORDATI RARE DISEASES ITALY S.R.L. |
99.00 | 99.00 | |||||||||
| RECORDATI BVBA | 99.46 | 0.54 | 100.00 | ||||||||
| FIC MEDICAL S.à r.l. | 100.00 | 100.00 | |||||||||
| HERBACOS RECORDATI s.r.o. | 100.00 | 100.00 | |||||||||
| RECORDATI SK s.r.o. | 100.00 | 100.00 |
| PERCENTAGE OF OWNERSHIP | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Consolidated companies | Recordati S.p.A. (Parent) |
Recordati Pharma GmbH |
Bouchara Recordati S.A.S. |
Casen Recordati S.L. |
Recordati Orphan Drugs S.A.S. |
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 | |||||||||
| PRO FARMA 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 (1) | 100.00 | 100.00 |
(1) Established in 2019
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 report corresponds to the document results, books and accounting records.
Milan, 29 October 2020
Signed by Luigi La Corte Manager responsible for preparing the Company's financial reports
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