cmyk · , stimulant of the vegetative nervous system. 1953. recordati moves the company to the...

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

1926 Recordati was founded in Correggio (Emilia, Italy) as “Laboratorio Farmacologico Reggiano” by Giovanni Recordati.

1927 Launch of Antispasmina Colica®, gastrointestinal tract antispasmodic.

1930 Launch of Solvobil®, cholagogue and laxative.

1935 Launch of Tefamin®, cardiotonic, diuretic and antihypertensive, followed by its associations.

1938 Launch of Simpamina®, stimulant of the vegetative nervous system.

1953 Recordati moves the company to the current site in Milan, the most important Italian economic centre.

1956 Launch of Recordil® (efloxate), coronary vasodilator.

1961 An exclusive license agreement is signed, later renewed until 2005, with Syntex Corporation (now part of Roche), at that time at the leading edge of research into the study and synthesis of steroidal hormones.

1962 Remeflin® (dimefline), respiratory analeptic, registered and commercialized.

1973 Flavoxate (Genurin®/Urispas® and other brands), a urinary anti-spasmodic still widely used, was launched. It was the first drug synthesized and developed in Italy to receive FDA approval in the USA.

1977 Antoral® (tibezonium iodide), an oral antiseptic, launched in Italy, performs well in a number of countries.

1984 The company is listed on the Italian Stock Exchange (Borsa Italiana, now part of the London Stock Exchange Group).

1986 Launch of Lomexin® (fenticonazole), a dermatological and gynecological anti-mycotic, widely used in many countries worldwide.

1995 Recordati outlines its growth and development strategy embarking on a process of internationalization. A subsidiary was established in Spain, now called Casen Recordati.

1997 First launch of Zanidip® (lercanidipine), a new antihypertensive drug entirely discovered and developed by Recordati.

1999 Recordati acquires the French pharmaceutical company Doms Adrian in France, the second largest pharmaceutical market in Europe.

2000 Expansion in France continues with the acquisition of the Bouchara pharmaceutical group.

2001 The two French companies are merged and the resulting subsidiary becomes Bouchara Recordati.

Conversion of all savings shares into ordinary shares and subsequent 2:1 stock split.

2002 The U.K. Medicines Control Agency granted a Product License (marketing approval) for Zanidip® (lercanidipine) 20 mg tablets.

2003 The 20mg strength of lercanidipine launched in a number of countries worldwide.

2004 The pharmaceutical pipeline is strengthened through the launch of new drugs.

2005 Recordati gains access to the largest pharmaceutical market in Europe and the third largest worldwide with the acquisition of Merckle Recordati in Germany, now Recordati Pharma.Establishment of Recordati Pharmaceuticals in the United Kingdom and of Recordati Hellas Pharmaceuticals in Greece.Recordati opens a new active pharmaceutical ingredients plant in Ireland. 4:1 stock split.

2006 Recordati acquires the Grupo Jaba companies in Portugal, today Jaba Recordati.Zanipress®, a fixed combination of lercanidipine and enalapril was approved for sale by BfArM (the German medicines agency).

2007 The first launch of Zanipress®. Acquisition of Orphan Europe, a European pharmaceutical group dedicated to the development, registration, marketing and distribution of unique drugs for the treatment of rare and orphan diseases.

2008 Acquisition of the French companies FIC and FIC Médical which are dedicated to the registration and the promotion of pharmaceutical products in Russia and other Commonwealth of Independent States (C.I.S.) countries.Acquisition of Yeni Ilaç (today Recordati Ilaç), a well-known pharmaceutical company in Turkey.

2009 Acquisition of Herbacos-Bofarma (today Herbacos Recordati), a pharmaceutical company operating in the Czech and Slovak markets.

2010 European Marketing Authorization obtained for silodosin (Urorec®, Silodyx®), an alpha blocker indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).Carbaglu® (carglumic acid) approved by the Food and Drug Administration (FDA) in the U.S. for the treatment of NAGS deficiency.Acquisition of ArtMed International in Romania, now Recordati Romania. European Marketing Authorization obtained for pitavastatin (Livazo®, Alipza®).

A LONG SUCCESS STORY. MORE THAN 90 YEARS OF ACTIVITY.

A LONG SUCCESS STORY. MORE THAN 90 YEARS OF ACTIVITY.

1926

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020

CMYK

2011 European approval to extend the use of Carbaglu® (carglumic acid) to treat hyperammonaemia due to either of the three main organic acidaemias.Acquisition of Dr. F. Frik Ilaç A.S. in Turkey. Acquisition of Procto-Glyvenol® a product indicated for the treatment of haemorrhoids.Recordati Polska is established in Poland. Launch of Livazo® (pitavastatin) in Spain and in Portugal.

2012 Acquisition of the marketing authorizations, the trademarks and additional assets concerning six OTC pharmaceuticals for Germany, the rights to five well-known product lines in Russia and other C.I.S. countries, and the leading oral care line of products bearing the Dentosan® trademark in Italy.Acquisition of Farma-Projekt a Polish pharmaceutical company.Recordati acquires all rights to a portfolio of products indicated for the treatment of rare and other diseases in the United States of America which is now marketed there by Recordati Rare Diseases.

2013 Acquisition of Opalia Pharma S.A. (now Opalia Recordati) and its cGMP certified production facility in Tunisia to establish a direct presence in North Africa.Acquisition of Laboratorios Casen Fleet S.L.U. (now Casen Recordati), a Spanish pharmaceutical company with headquarters in Madrid and production facilities in Utebo, Zaragoza.

2014 U.S. Food and Drug Administration (FDA) granted orphan drug designation for the use of Carbaglu® (carglumic acid) in the treatment of organic acidemias (OAs).License agreement signed with Apricus Biosciences Inc. for the marketing and sales of Vitaros® (alprostadil), a topical product for the treatment of erectile dysfunction, and with Plethora Solutions for the commercialization of Fortacin™, a topical spray formulation of lidocaine and prilocaine for the treatment of premature ejaculation.

2015 Establishment of subsidiaries in Brazil, Mexico and Colombia for the commercialization of treatments for rare diseases.Carbaglu® (carglumic acid) was authorized for sale by Health Canada for the treatment of acute and chronic hyperammonaemia due to NAGS deficiency.

2016 Acquisition of Italchimici S.p.A., an Italian pharmaceutical company, and Pro Farma AG, now Recordati AG, a Swiss pharmaceutical company that operates also in Austria.Agreement with AP-HP (Assistance Publique – Hopitaux de Paris) for the development and commercialization of a product for the treatment of acute decompensation episodes in patients affected by Maple Syrup Urine Disease (MSUD).

A license agreement with Gedeon Richter was signed to commercialize cariprazine, a novel atypical antipsychotic.

2017 Approval of Cystadrops® the first eye-drop solution containing cysteamine hydrochloride approved in the European Union for the treatment of corneal cystine crystal deposits. Agreement with the Meyer Hospital in Florence (Italy) for the development of a treatment for pre-term babies affected by retinopathy of prematurity. Acquisition from AstraZeneca the European rights to Seloken®/Seloken® ZOK (metoprolol succinate) and Logimax® (metoprolol succinate and felodipine).Agreement with MimeTech for the development and commercialization of a peptidomimetic of human nerve growth factor for the treatment of neurotrophic keratitis.Acquisition of three Bayer Consumer Health brands in France, Transipeg®, TransipegLib® and Colopeg®.

2018 Acquisition from Mylan of the rights to Cystagon® (cysteamine bitartrate), indicated for the treatment of proven nephropathic cystinosis. Acquisition of Natural Point S.r.l., an Italian company active in the food supplements market whose main product is Magnesio Supremo®.A license obtained from Helsinn for the exclusive rights to Ledaga® (chlormethine hydrochloride), a novel gel formulation indicated for the topical treatment of mycosis fungoides, worldwide excluding the United States, China, Hong Kong and Israel. The product has been granted Orphan Drug Designation in Europe and is approved by the European Commission.Acquisition of Tonipharm S.A.S., a French company well known for its brands Ginkor® based on ginko biloba and Alodont®, a line of products used for oral hygiene.Launch of Reagila® (cariprazine), a new atypical antipsychotic for the treatment of schizophrenia, in Europe.

2019 License agreement with Aegerion Pharmaceuticals Inc., for the exclusive rights to commercialize Juxtapid® (lomitapide), indicated for the treatment of homozygous familial hypercholesterolemia (HoFH), in Japan. Recordati Rare Diseases, a worldwide leader in rare diseases and orphan drugs, becomes the global brand of the Recordati’s organization dedicated to treatments for rare diseases. All companies formerly operating under the name of Orphan Europe were renamed Recordati Rare Diseases. Acquisition from Novartis of worldwide rights to Signifor® and Signifor® LAR® (pasireotide) for the treatment of Cushing’s disease and acromegaly. The agreement also covers the acquisition of worldwide rights to Isturisa® (osilodrostat), an innovative drug for the treatment of endogenous Cushing’s syndrome.

IV |

MORE THAN 90 YEARS OF HISTORY

Since 1926, the Recordati group successfully faces the challengesof a market in continuous evolution and identifies fitting

business opportunities as they arise.

2 | RECORDATI

RECORDATI A GROWING RENOWNED INTERNATIONAL PHARMACEUTICAL GROUP

Recordati is based in Milan, Italy and is listed on the Italian Stock Exchange

(London Stock Exchange Group) since 1984.

Recordati produces and promotes a wide range of innovative products in over 150 countries.

Recordati’s portfolio includes both products for primary and specialty care and treatments

for rare diseases.

The Group markets a number of specialties generated by its original research.

The Recordati group is the European partner of leading international pharmaceutical companies.

The Recordati group grows constantly thanks to the quality of its products and to the implementation of an internationalization policy based on a focused strategy of selective acquisitions and license agreements.

2 |

| 3RECORDATI - A GROWING RENOWNED INTERNATIONAL PHARMACEUTICAL GROUP

RECORDATI AND THE MARKET

With operations in all European countries, in Russia and in the CIS countries, in Turkey

and North Africa, in the U.S.A., Canada, Latin America, Japan and Australia, Recordati

continues to strengthen its geographical presence.

Recordati constantly enhances its therapeutic offering through the development

of its product pipeline with a focus on rare diseases.

RECORDATI, A GROWING COMMITMENT TO THE TREATMENT OF RARE DISEASES

The Recordati group works towards improving the quality of life of people suffering from rare

diseases together with patients and their families, with doctors and with the support of a highly

specialized internal team.

Recordati develops, produces and sells drugs for the treatment of rare diseases, and operates

worldwide in a highly specialized market with a significant growth potential.

| 3

4 | RECORDATI

A GROWING PRESENCE IN NEW MARKETS

In the future the Recordati group will continue to focus on the development of its business both

by growing its product portfolio and reinforcing its presence in selected markets.

Recordati will continue to increase its activity in Europe, which is the second largest

pharmaceutical market in the world, and to make its products for the treatment of rare diseases

available worldwide including the U.S.A., the largest market, Canada, Latin America, Japan and

the Asia-Pacific regions.

A RICHER PRODUCT PORTFOLIO

The launch of innovative new products, the enhancement of its product portfolio with specialties

from its own research and development or from targeted license agreements or specific

acquisitions, will boost the group’s growth.

The extensive geographical coverage, an efficient field force of medical representatives and

orphan drug specialists, the significant competence in handling regulatory processes, the

profound know-how in the handling of highly specialized products, all make the Recordati group

an ideal partner for the development and marketing of new products in its markets.

THE RECORDATI GROUP BETWEEN PRESENT AND FUTURE

The proven ability for creating profitable partnerships with important players in the pharmaceutical sector will continue to support the Recordati group in its quest to identify new partners and finalize new license agreements for the development of high value medicinal products.

A WORLDWIDE SUCCESSWE WILL KEEP ON BUILDING

TOGETHER

4 |

| 5THE RECORDATI GROUP BETWEEN PRESENT AND FUTURE

CONSTANT INVESTMENT IN RESEARCH AND INNOVATION

Recordati is committed towards the innovation and marketing

of high value added products and therefore constantly develops

new medicines and believes research and development is a

fundamental basis for its growth.

Dedication and scientific rigor are always behind Recordati’s

specialties and self-medication products which are also produced

with the highest levels of quality and safety.

Recordati’s proven ability to generate profitable alliances with

prominent players in the pharmaceutical industry is the basis

of an increasingly intense activity in executing new license

agreements for the development of innovative products.

A WORLDWIDE SUCCESSWE WILL KEEP ON BUILDING

TOGETHER

R&D EXPENSESMillions of Euro

76.783.7

100.2109.7

129.7

2015 2016 2017 2018 2019

| 5

6 | RECORDATI

TODAY’S NUMBERS

REVENUE 1,481.8 millions of euro

NET INCOME 368.9 millions of euro

NET FINANCIAL POSITION (902.7) millions of euro

SHAREHOLDERS’ EQUITY 1,198.8 millions of euro

DIVIDEND 1.00 euro per share

EMPLOYEES exceed 4,300

2019 was a very favourable year for the groupand a number of initiatives were pursued

for the company’s future development.

6 |

| 7TODAY’S NUMBERS

REVENUEMillions of Euro

1047.71153.9

1288.11352.2

1481.8

2015 2016 2017 2018 2019

EBITDA* Millions of Euro

317.0

371.2

454.7499.0

544.0

2015 2016 2017 2018 2019

EBITDA* AS % OF REVENUE

30.332.2

35.336.9 36.7

2015 2016 2017 2018 2019

NET INCOMEMillions of Euro

198.8

237.4

288.8312.4

368.9

2015 2016 2017 2018 2019

NET INCOME AS % OF REVENUE

19.0

20.6

22.4 23.1

24.9

2015 2016 2017 2018 2019

NET INCOME PER SHARE Euro

0.968

1.152

1.3951.529

1.800

2015 2016 2017 2018 2019

DIVIDEND PER SHARE Euro

0.60

0.70

0.850.92

1.00

2015 2016 2017 2018 2019

* Net income before net interest, provision for taxes, depreciation, amortization and write down of both property, plant and equipment and intangible assets.

INTERNATIONAL BUSINESS GROWTH TREND

79.8%

79.4%

79.9%

79.8%

80.6%

2015 2016 2017 2018 2019

BALANCE SHEET at 31 December 2019

42.68% Shareholder’s Equity

20.89% Current Liabilities

28.81% Current Assets

36.43% Non-current Liabilities

71.19% Non-current Assets

| 7

8 | RECORDATI

GEOGRAPHICAL PRESENCE

SPECIALTY & PRIMARY CARE

nSubsidiaries

n Branches and other forms of territorial presence

n Countries where Recordati products are sold (under license or export)

EXCEEDS

150 COUNTRIES

8 |

| 9GEOGRAPHICAL PRESENCE

TREATMENTS FOR RARE DISEASES

nSubsidiaries and direct presence of orphan drug representatives

nCommercial agreements and direct delivery

GEOGRAPHICAL COMPOSITION OF PHARMACEUTICAL SALES

(First Quarter 2020)EXCEEDS

150 COUNTRIES∙ 18.8% Italy

∙ 9.9% France

∙ 9.4% Germany

∙ 8.5% Russia, Ukraine, other CIS

∙ 7.6% USA

∙ 6.6% Turkey

∙ 6.0% Spain

∙ 3.1% Portugal

∙ 6.7% Other CEE

∙ 5.9% Other Western Europe

∙ 2.9% North Africa

∙ 14.6% Other international sales

| 9

10 | RECORDATI

RECORDATI’S SUCCESSFUL PRODUCTS

The Recordati group:

makes available to healthcare professionals and patients numerous medicines belonging to

various therapeutic areas;

boasts an important presence in the areas of cardiovascular, urological and psychiatric disorders

for which it offers new treatments;

markets products originated by its own research and by specific license agreements

by promoting a wide range of innovative drugs.

A number of innovative high value added specialties comprise a largeand qualified product portfolio.

10 |

| 11RECORDATI’S SUCCESSFUL PRODUCTS

COMPOSITION OF REVENUE BY BUSINESS (2019)

PHARMACEUTICAL SALES BY THERAPEUTIC AREA (2019)

43.5% Corporate Products

18.6% OTC

17.0% Subsidiaries’ Local products

16.9% Treatments for Rare Diseases

0.9% Other Revenue

3.1% Pharmaceutical Chemicals

∙ 30.8% Cardiovascular

∙ 23.8% Alimentary tract & metabolism

∙ 13.8% Genito-urinary system

∙ 7.6% Respiratory system

∙ 6.5% Musculo-skeletal system

∙ 5.3% Blood and blood forming organs

∙ 3.7% Central Nervous System

∙ 2.9% Sensory organs

∙ 1.7% Dermatology

∙ 1.5% Anti-infectives for systemic use

∙ 1.4% Antineoplastic

∙ 1.0% Other international sales

| 11

12 | RECORDATI’S SUCCESSFUL PRODUCTS

CORPORATE PRODUCTSSPECIALTY & PRIMARY CARE

®

Sodio picosolfato - Magnesio ossido leggero - Acido citrico anidro

P 293

COLORI SPECIALI CMYK

C 100 M 57 Y O K 2

C 0 M 0 Y O K 60FONT: Arno Pro Semibold Display

P Cool Gray 10 C

Seloken ZOK®

1 Metoprolol succinate

Seloken®

1 Metoprolol tartrate

Betaloc ZOK®


LogimaxFelodipine/metoprolol succinate ER

®

Seloken ZOK®


Seloken®


Betaloc ZOK®



®

Seloken ZOK®


Seloken®


Betaloc ZOK®



®

Seloken ZOK®


Seloken®


Betaloc ZOK®



®

ZANIDIP®/CORIFEO®/LERCADIP® (lercanidipine) antihypertensive

ZANIPRESS®/ZANEXTRA®/LERCAPREL®/LERCARIL® (lercanidipine + enalapril) antihypertensive

UROREC® (silodosin) benign prostatic hyperplasia

LIVAZO®/ALIPZA® (pitavastatin) hypercholesterolaemia

SELOKEN®/SELOKEN®ZOK/BETALOK®ZOK (metoprolol succinate) angina pectoris, disturbances of cardiac rhythm, hypertension

LOGIMAX® (metoprolol succinate + felodipine) antihypertensive

TERGYNAN® gynecological infections

CITRAFLEET® and FOSFOSODA® bowel evacuants

POLIDEXA®, ISOFRA® and OTOFA® treatment of ear, nose and throat (ENT) infections

REUFLOR®, CASENBIOTIC®, BIORALSUERO®, REUTERI®, GASTRUS® (lactobacillus reuteri protectis) food supplements

REAGILA® (cariprazine) antipsychotic

12 |


OXYBUTYNIN TRANSDERMAL PATCH

Lopresor®

PANTONE: 214 C

Font: DIN BOLD

0 C, 100 M 34 Y, 8K

BEŞERİ TIBBİ ÜRÜNÜN ADI: CASENLAX 4 g oral çözelti hazırlamak için toz içeren saşe ve CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe ETKİN MADDE: CASENLAX 4 g oral çözelti hazırlamak için toz içeren saşe: Her bir saşe 4g Makrogol 4000 ve CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe: Her bir saşe 10 g Makrogol 4000 içerir. ENDİKASYONLARI: CASENLAX 4 g oral çözelti hazırlamak için toz içeren saşe: 6 ay – 8 yaş arası çocuklarda konstipasyonun semptomatik tedavisinde endikedir. Özellikle 2 yaşın altındaki çocuklarda tedaviye başlanmadan önce, herhangi bir organik hastalık varlığı hekim tarafından bertaraf edilmelidir. Konstipasyonun tedavisinde sağlıklı bir diyet ve yaşam tarzı ile birlikte, sadece geçici olarak kullanılmalı. CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe: Yetişkinler ile 8 yaş ve üzeri çocuklarda konstipasyonun semptomatik tedavisinde endikedir. Tüm laksatiflerde olduğu gibi tedaviye başlanmadan önce, herhangi bir organik hastalık olasılığı dışlanmalıdır. Konstipasyonun tedavisinde sağlıklı bir diyet ve yaşam tarzı ile birlikte, sadece geçici olarak kullanılmalıdır. CASENLAX çocuklarda 3 aydan daha uzun süreli kullanılmamalıdır. Sağlıklı yaşam tarzı ve diyet uygulamasına rağmen konstipasyon devam ederse, altta yatan bir sebepten şüphelenilmeli ve bu durum tedavi edilmelidir. POZOLOJİ: CASENLAX 4 g oral çözelti hazırlamak için toz içeren saşe: Pediyatrik popülasyon: 6 ay – 1 yaş arası: günde 1 saşe; 1 yaş – 4 yaş: günde 1 – 2 saşe; 4 yaş – 8 yaş: günde 2 – 4 saşe . Çocuklarda tedavi 3 ayı geçmemelidir. İntestinal geçişte tedavi ile sağlanan düzelme yaşam tarzı ve diyet değişiklikleri ile sürdürülmelidir. Tedavi kademeli olarak sonlandırılmalı ve konstipasyon tekrarlarsa devam edilmelidir. CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe: Tercihen sabahları tek doz olarak uygulanan günde 1-2 saşe. Her uygulamadan sonra 125 ml sıvının (örneğin su) içilmesi önerilir. CASENLAX etkisini uygulamadan sonraki 24 - 48 saat içinde gösterir. Günlük dozaj, elde edilen klinik etkiye göre ayarlanmalıdır. Doz; gün aşırı 1 saşe (özellikle çocuklarda) ile günde maksimum 2 saşe uygulanması arasında değişmektedir. Tedavi kademeli olarak sonlandırılmalı ve konstipasyon tekrarlarsa devam edilmelidir. Uygulama şekli: CASENLAX oral olarak uygulanır. Her bir saşe içeriği kullanılmadan hemen önce bir bardak (yaklaşık 125 ml) suda çözünür. Berrak ve şeffaf bir çözelti meydana gelir. Böbrek/Karaciğer yetmezliği: Veri bulunmamaktadır. Pediyatrik popülasyon: CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe: Tercihen sabahları tek doz olarak, günde 1-2 saşe olarak uygulanır. Her uygulamadan sonra 125 ml sıvının (örneğin su) içilmesi önerilir. Çocuklarda kullanım 3 ayı geçmemelidir. İntestinal geçişte tedavi ile sağlanan düzelme yaşam tarzı ve diyet değişiklikleri ile sürdürülmelidir. Geriyatrik popülasyon: Veri bulunmamaktadır. KONTRENDİKASYONLARI: Etkin maddeye ya da yardımcı maddelerden herhangi birine hipersensitivite, semptomatik stenoz ile ilişkili şiddetli inflamatuvar bağırsak hastalığı (ülseratif kolit, Crohn hastalığı, vs.) veya toksik megacolon, Sindirim sistemi perforasyonu veya perforasyon riski, İleus veya intestinal obstrüksiyon şüphesi, sebebi bilinmeyen ağrılı abdominal sendromlar ÖZEL KULLANIM UYARILARI: Konstipasyonun herhangi bir tıbbi ürün ile tedavisi, aşağıda örneklendirilmekte olan yaşam tarzı ve diyetsel yaklaşımları destekler: Diyette sıvı ve lif alınımının arttırılması, uygun fiziksel aktivite ve bağırsak reflekslerini iyileştirme, diyare durumunda, su ve elektrolit dengesi bozukluğuna yatkın hastalarda (örneğin yaşlı hastalar, karaciğer veya böbrek fonksiyon bozukluğu olan hastalar veya diüretik kullanan hastalar) dikkatli olunmalı ve elektrolit kontrolü düşünülmelidir. Makrogol (polietilen glikol) içeren ürünlerin kullanılması ile hipersensitivite reaksiyonları (kızarıklık, ürtiker, ödem), istisnai anafilaktik şok vakaları bildirilmiştir. Makrogol’ün etki mekanizmasından dolayı CASENLAX ile tedavi sırasında sıvı alınması önerilmektedir. Diğer tıbbi ürünlerin absorbsiyonu, makrogol’ün neden olduğu gastrointestinal geçiş hızındaki artışa bağlı olarak, geçici olarak azalabilir. CASENLAX her bir saşede 0,00064(CASENLAX 4 g) ve 0,0000018 mg (CASENLAX 10 g) sülfür dioksit içermektedir. Bu sülfür dioksit nedeniyle nadir olarak şiddetli aşırı duyarlılık reaksiyonları ve bronkospazma neden olabilir. İLAÇ ETKİLEŞİMLERİ VE DİĞER ETKİLEŞİMLER: Diğer tıbbi ürünlerin absorbsiyonunda geçici azalmalar olabilir. Terapötik indeksi dar olan ilaçların terapötik etkisi değişebilir (ör. antiepileptikler, digoksin ve immünsupresif ilaçlar). GEBELİK VE LAKTASYONDA KULLANIMI Gebelik Kategorisi: C Gebelik dönemi Sistemik maruziyet ihmal edilebilir düzeydedir, dolayısıyla gebelik süresince kullanımında herhangi bir olumsuz tesir beklenmemektedir. Laktasyon dönemi: Emzirme döneminde kullanılabilir. Üreme yeteneği/Fertilite CASENLAX ile herhangi bir fertilite çalışması gerçekleştirilmemiştir. Ancak makrogol 4000 kayda değer bir emilim göstermediğinden, herhangi bir etki beklenmemektedir. Araç ve makine kullanımı üzerindeki etkiler: CASENLAX’ın araç ve makine kullanımı üzerine herhangi bir etkisi yoktur. İSTENMEYEN ETKİLER: Erişkin popülasyon: Yaygın: Abdominal ağrı ve/veya distansiyon, bulantı, diyare Yaygın olmayan: Kusma, acil defekasyon ihtiyacı, fekal inkontinans Çok seyrek: Hipersensitivite reaksiyonları (Kaşıntı, döküntü, yüzde ödem, Quincke ödemi, ürtiker, anafilaktik şok) Bilinmiyor: Eritem, elektrolit bozuklukları (hiponatremi ve hipokalemi) ve/veya dehidratasyon. Pediyatrik popülasyon: Yaygın: Abdominal ağrı, diyare* Yaygın olmayan: Bulantı, kusma, şişkinlik hissi *diyare perianal ağıya neden olabilir. Bilinmiyor: Hipersensitivite reaksiyonları (Anafilaktik şok, anjiyoödem, ürtiker, döküntü, kaşıntı) FARMAKOLOJİK ÖZELLİKLER: ATC kodu: A06AD15 Farmakoterapötik grup: Konstipasyonda kullanılan ilaçlar. Ozmotik laksatifler RUHSAT SAHİBİ: Recordati İlaç San. ve Tic. A.Ş. Ç.O.S.B. Karaağaç Mah. Atatürk Cad. No:36 Kapaklı/TEKİRDAĞ Tel: 0 282 999 16 00 AMBALAJIN NİTELİĞİ VE İÇERİĞİ : Dış tabakası polyester, orta tabakası alüminyum ve iç tabakası polietilen, tek dozluk saşeler. 20 tek-dozlu saşe, hasta Kullanma Talimatı ile birlikte kutu içerisinde ambalajlanır. PERAKENDE SATIŞ FİYATI: CASENLAX 4 g oral çözelti hazırlamak için toz içeren saşe 20 saşe/kutu 29,90 TL KDV dahil (Şubat 2019) ve CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe 20 saşe/kutu 41,46 TL KDV dahil (Şubat 2019) RUHSAT TARİH VE NUMARASI: CASENLAX 4 g oral çözelti hazırlamak için toz içeren saşe: 27.07.2017 ve 2017/542 CASENLAX 10 g oral çözelti hazırlamak için toz içeren saşe: 27.07.2017 ve 2017/543 KÜB’ÜN SON GÜNCELLEME TARİHİ: 11.12.2018 Reçete ile satılır. Ayrıntılı bilgi için lütfen firmamıza başvurunuz.

CA

S/B-

2019

Q4-

02

ÇilekAromalı

ElmaAromalı

KABIZLIĞI

D

URDUR

Casenlax

®10gCasen

lax®10g

ORAL ÇÖZELTİ HAZIRLAMAK İÇİN TOZ İÇEREN SAŞE

SELOKEN®/SELOKEN®ZOK/BETALOK®ZOK (metoprolol succinate) angina pectoris, disturbances of cardiac rhythm, hypertension

PROCTO-GLYVENOL® (tribenoside) haemorrhoids

HEXA LINE OF PRODUCTS (biclotymol) antibacterial for infections of the oral cavity

LOMEXIN® /FALVIN® (fenticonazole) antimycotic

CASENLAX®/LAXBENE® and FLEET ENEMA® constipation and bowel cleansing

TRANSACT® LAT (flurbiprofen transdermal patch) anti-inflammatory

URISPAS® /GENURIN® (flavoxate) urinary tract muscle relaxant

KENTERA® (oxybutynin transdermal patch) hyperactive bladder

RUPAFIN®/WYSTAMM® (rupatadine) antihistamine

LOPRESOR® (metoprolol) antihypertensive

ABUFENE® and MUVAGYN® symptoms of menopause

LACDIGEST (tilactase) Lactose intolerance

VITAROS®/VIRIREC® (alprostadil) erectile dysfunction

FORTACIN® (lidocaine+prilocaine) premature ejaculation

Gyno-Lomexin®

Fentikonazol

Büyük bir etki!

Küçük bir hareketle

| 13


SUBSIDIARIES’ LOCAL PRODUCTS

Some products or product lines marketed locally by Recordati’s subsidiaries detain prominent positions in their markets of reference.

GEOGRAPHICAL COMPOSITION OF PHARMACEUTICAL REVENUE

(2019)

55.2% Western Europe

14.1% Eastern Europe

9.0% Turkey and North Africa

7.6% USA

14.1% Others

COD. 39763012

LOSIPACO DUE AZIONI, UN RIMEDIO.

Per l’uso in gravidanza

consultare il medico

È un medicinale. Leggere attentamente il foglio illustrativo. Autorizzazione del 04/04/2019

pagina ADV.indd 1 15/04/19 09:03

14 |


In addition to its consolidated presence in the cardio-metabolic area, Recordati in Italy offers

innovative treatments in the areas of urology, gastroenterology, psychiatry, analgesia as well as

food supplements, with the successful commercialization of Magnesio Supremo®, a particular

formulation of magnesium is easily assimilated into the body.

Bouchara Recordati is well known in the French market thanks to a number of prescription and

self medication products. It is the exclusive licensee for the production and commercialization of

methadone, a synthetic opioid analgesic. The company has also developed an important international

presence in the Maghreb area and in French-speaking Africa and Asia where a dynamic export and

promotion business distributes its specialties in more than 30 countries.

Recordati Pharma in Germany supplies first class products to orthopaedic specialists and to

gastroenterologists, in particular as related to chronic inflammatory intestinal disorders such as

Crohn’s disease and ulcerative colitis.

COD. 39763012

LOSIPACO DUE AZIONI, UN RIMEDIO.

Per l’uso in gravidanza

consultare il medico

È un medicinale. Leggere attentamente il foglio illustrativo. Autorizzazione del 04/04/2019

pagina ADV.indd 1 15/04/19 09:03

| 15


Rusfic, Recordati Ukraine and FIC Médical, our organizations operating in Russia, Ukraine,

the other CIS markets and the Central Asia successfully markets products indicated for

otorhinolaryngological and vaginal infections which boast a leading position in their markets.

Casen Recordati in Spain counts on an extensive and substantial portfolio of products, well

appreciated in the area of gastroenterology where its products for bowel cleansing and oral

rehydration are undisputed market leaders.

In Turkey Recordati Ilaç markets a diversified product portfolio well appreciated by the practitioner,

in the fields of urology, cardiology, gynecology and in physical medicine and rehabilitation.

Opalia Pharma operates in North Africa and in Tunisia, where it is one of the largest local

pharmaceutical companies marketing branded generic drugs with leading products in dermatology

and in the gastrointestinal and respiratory therapeutic areas.

Recordati has reinforced its presence in Switzerland with the subsidiary Recordati AG, that has

its headquarters in Zug and operates also in Austria, as from 2018 in Sweden, Denmark, Norway,

Finland, Iceland with Recordati AB and in BeNeLux with Recordati BV, as from 2019 with Recordati

Bulgaria LTD in Bulgaria.

16 |

| 17RECORDATI

THE RECORDATI GROUP AND ITS SELF-MEDICATION PRODUCTS

The Recordati group is also present in the self-medication market segment with well-known

brands. It is committed to the improvement of quality of life by offering a choice of successful

products.

Recordati constantly seeks new treatments to offer patients and has further extended its portfolio

of OTC products, food supplements and treatments to improve health and well-being.

All Recordati’s pharmaceutical specialties and self-medication products are characterized

by high levels of quality and safety in all countries.

| 17

RECORDATI AND THE TREATMENT OF RARE DISEASES

Rare diseases bring great suffering to millions of affected people worldwide.

A rare disease is defined as a condition that affects fewer than 5 per 10,000 inhabitants in Europe

or fewer than 200,000 Americans in the U.S.A..

There are more than 7,000 known rare diseases but today approved treatments exist for fewer

than 10% of these.

The acquisition and diffusion of specific scientific knowledgeis fundamental for the identification of a rare disease and is of great importance in the research for new therapies.

18 | RECORDATI18 |

It develops, produces and markets drugs for the treatment of a number of rare diseases.

These are marketed directly in Europe, the Middle East, U.S.A., Canada, Russia, Australia, Japan

and in some Latin American countries, and through selected partners in other parts of the world.

The Recordati group operates in the rare disease segment worldwide through its dedicated company Recordati Rare Diseases.

| 19RECORDATI AND THE TREATMENT OF RARE DISEASES | 19

Highly trained specialists and a scientific support team collaborate constantly with researchers,

medical practitioners and healthcare professionals, with patient groups and families and

with regulators to treat and improve the quality of life of people suffering from these diseases

worldwide.

Thanks to a unique distribution system and to specialists dedicated to the promotion and

distribution of these products, the group is able to reach patients in their home countries.

The Recordati group makes available to doctors and their patients a team of highly trained specialists and a number of specific drugs.

20 | RECORDATI AND THE TREATMENT OF RARE DISEASES20 |

The Recordati group makes available to doctors and their patients a team of highly trained specialists and a number of specific drugs.

OUR DRUGS FOR RARE DISEASES

| 21RECORDATI AND THE TREATMENT OF RARE DISEASES

NAME ACTIVE INGREDIENT INDICATION

CARBAGLU®

carglumic acid Treatment of hyperammonemia due to N-acetylglutamate synthase deficiency (NAGS deficiency) and some organic acidaemias (isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia)

NORMOSANG®

PANHEMATIN®human hemin Treatment of acute attacks of hepatic porphyria

SIGNIFOR® and SIGNIFOR® LAR

pasireotide Treatment of Cushing’s disease and acromegaly

ISTURISA® osilodrostat Treatment of endogenous Cushing’s syndrome/Cushing’s disease

COSMEGEN® dactinomycin injectable Treatment of three rare cancers

CYSTADANE® betaine anhydrous Treatment of homocystinuria

CYSTADROPS® cysteamine chlorhydrate Treatment of the ocular manifestations of cystinosis

PEDEA® NEOPROFEN®

ibuprofene iv Treatment of patent ductus arteriosus (PDA)

CYSTAGON® cysteamine bitartrate Treatment of nephropathic cystinosis

JUXTAPID® lomitapide Treatment of homozygous familial hypercholesterolemia (HoFH)

LEDAGA® chlormethine hydrochloride Treatment of mycosis fungoides, T-cell lymphoma (MF-CTCL)

| 21

Recordati’s commitment to making its products available to patients suffering from rare diseases

was recognized by the National Organization for Rare Disorders (NORD) in the U.S.A. with its

“Corporate Award”. This important award was granted in 2011 in recognition of the introduction into

the United States of Carbaglu®, the first specific treatment approved by the FDA (Food and Drug

Administration) for NAGS deficiency, a very rare inherited metabolic disease.

The important results obtained in improving the diagnosis and management of rare diseases were

recognized by EURORDIS (European Organization for Rare Diseases) with an award presented during

the celebration of the 2014 Rare Disease Day. The award also distinguishes its established track

record in the field of orphan drug development, the establishment of scientific networks, engaging

with patient organizations together with its efforts to reduce the impact of disease on the lives of

patients.

22 | RECORDATI AND THE TREATMENT OF RARE DISEASES22 |

Recordati is committed to supporting families affected by these diseases through the research and development of new therapies and through the diffusion of specific scientific knowledge withinthe medical community.

The Recordati Rare Diseases Fondation d’entreprise targets specialized healthcare professionals

and its aim is to improve and to spread currently available knowledge on rare diseases.

The organization promotes scientific collaboration, the sharing of experiences and knowledge

among sector specialists and the development of new ideas.

Every year the Academy proposes theoretical and practical courses as well as e-learning online

courses which aim to provide physicians, world-wide, with clinically useful and the most

up-to-date information concerning current knowledge and recommendations for care.

| 23RECORDATI AND THE TREATMENT OF RARE DISEASES

THE RECORDATI RARE DISEASES FONDATION D’ENTREPRISE

| 23

24 | RECORDATI

RESEARCH AND INNOVATION AT RECORDATI

The Recordati group constantly develops new specialties originated either internally or acquired

through development agreements with other pharmaceutical companies and research institutes.

Commitment, scientific rigor, capability and highly specialized personnel allow Recordati

to develop new treatments and to count on an innovative product pipeline.

Recordati’s research and development activities are mainly focused on generating innovative

treatments with a focus on rare diseases.

The introduction of new products, both through our discovery programsas well as through alliances with other companies and with research institutes:this is Recordati’s commitment and is a fundamental premise for its growth.

24 |

| 25RESEARCH AND INNOVATION AT RECORDATI

PRODUCT DEVELOPMENT PIPELINE

NAME ORIGINATOR INDICATION DEVELOPMENT STATUS

ISTURISA® Novartis Endogenous Cushing’s syndrome/ Cushing’s disease

Approved in Europe. Approved in the USA.

CYSTADROPS® Recordati Corneal cysteine crystal deposits in patients with cystinosis

Filed in the USA. Development of new formulations in EU and in USA.

REAGILA® Gedeon Richter Schizophrenia Pediatric post-approval development plan.

Metadone Treatment of cancer-related pain in cases of resistance or intolerance to other opioids

Approved in France.

CARBAGLU® Orphan Europe (Recordati)

Hyperammonaemia due to NAGS deficiency and to the main organic acidemias

Development of new formulations in EU and USA. Filed in the USA for the organic acidemias indication.

REC 0438 Recordati/UFPeptides New indications Preclinical development.

REC 0559 Recordati/MimeTech Neurotrophic keratitis Formulation development. Clinical development planning.

REC 0545 Recordati/AP-HP Acute decompensation episodes in MSUD

Formulation development. Retrospective study in France and Germany.

| 25

26 | RECORDATI

Recordati has a strong track record in generating value through partnerships with other

pharmaceutical companies, local or global players.

It is committed to generating further growth through mutually beneficial R&D collaborations,

license agreements, acquisitions.

The Recordati group has commercial operations throughout the European pharmaceutical market

and has a strong and growing interest in new markets.

It has affiliates in Western Europe (Italy, France, Germany, BeNeLux, Portugal, Spain, Switzerland,

United Kingdom and Ireland) and in Sweden, in Central Europe (Greece, Poland, the Czech

Republic, Slovakia, Romania, Bulgaria), in Russia and the other CIS countries, in Ukraine as well

as in Turkey and Tunisia.

It is also present in the Middle East, in the U.S.A., Canada, Japan, Australia and some Latin

American countries with its treatments for rare diseases.

PARTNERING WITH THE RECORDATI GROUP

26 |

| 27PARTNERING WITH THE RECORDATI GROUP

Thanks to its capability in developing successful relationships, Recordati has enacted an intelligent policy of partnering with companies of high standing in the pharmaceutical segment and made targeted acquisitions in markets characterized by high growth potential thus generating value for itself and its partners.

The group disposes of a strong team of experienced sales and marketing professionals.

Recordati has proven R&D experience in developing treatments for cardiovascular, urology

disorders and rare diseases.

Its proven capabilities in the management of regulatory procedures and clinical trials in the EU,

MENA (Middle East and North Africa) and in the USA make Recordati an ideal partner for

the development and commercialization of new products.

The extensive know-how acquired and dedicated industrial resources allow the company to fully

cover the manufacturing chain, from active ingredient to finished product, in its own facilities

in Italy, France, Ireland, Spain, Turkey and Tunisia.

The financial solidity of the group allows it to support targeted R&D investments.

| 27

28 | PARTNERING WITH THE RECORDATI GROUP

SELECTED PARTNERSHIPS

The Group, which covers almost all of the European pharmaceutical market with a direct presence also in the USA, proposes itself as an ideal partner for the development and commercialization of new products in its territories.

LICENSOR TRADEMARK ACTIVE INGREDIENT RIGHTS FOR

Aegerion Pharmaceuticals

Juxtapid® lomitapide Japan

Almirall Cidine® cinitapride Spain

Amdipharm/ Advanz Pharma

TransAct® LAT flurbiprofene Italy, Portugal

Ferring International Center

Vitaros®/Virirec® alprostadil Spain, Ireland, Portugal, Greece, Cyprus, Czech Republic, Poland, Romania, Slovakia, Commonwealth of Independent States, Turkmenistan, Ukraine, Georgia, Turkey and African Portuguese-speaking countries

Gedeon Ritcher Reagila® cariprazine Western Europe, some countries in Africa, Turkey

Helsinn Ledaga® chlormethine hydrochloride

Worldwide, exc. the United States, China, Hong Kong and Israel

Kissei Urorec®/Silodyx™/ Silosin®

silodosin Europe & Others

Kowa Livazo®/Alipza® pitavastatin Europe, exc. UK, Germany

Merck KGaA Cardicor® bisoprolol Italy

Ono-UCB Alprostar® PGE 1 Alpha Italy

Plethora Fortacin™ lidocaine + prilocaine Europe, Russia, Commonwealth of Independent States, Turkey, North Africa

Rottapharm/ Madaus

Dermatrans®/ Epinitril®

nitroglicerine TDS Spain, France

Sandoz Leptoprol leuproreline France

Takeda Peptazol® pantoprazole Italy

Teva Kentera® oxybutynin TDS 29 European countries

Uriach Wystamm®/Rupafin® rupatadine France, Germany, Italy

28 |

| 29SUSTAINABILITY FOR THE RECORDATI GROUP

SUSTAINABILITY FOR THE RECORDATI GROUP

As part of its constant dedication to the discovery, development and sale of innovative value-added products with the aim of improving health and quality of life, the Recordati group is committed to research, innovation and quality while creating value for its stakeholders, all of which are distinctive elements of the Group’s corporate social responsibility.

The Recordati group has initiated a structured and organic sustainability process in line with its

strategic, organizational and operational characteristics.

Recordati operates all over the world in full respect of human rights.

It manages its relationship with employees, collaborators and suppliers in full respect of

the principles and values included in the Group’s Code of Ethics and in accordance with the

Conventions of the International Labour Organization in all of the countries in which it operates.

In addition to ensuring the Group’s development on an international level and focusing on the

treatment of rare diseases, the Group, when defining its strategy and operational policies,

considers the interests of all stakeholders, taking into account not only the economic, but also

the social and environmental impact of its activities.

Recordati ensures that its success benefits not only patients but also all those who collaborate

with the Group: employees, clients, consumers, patients and their associations, investors

and the financial community, suppliers and strategic partners.

| 29

30 | SUSTAINABILITY FOR THE RECORDATI GROUP

CORPORATE SOCIAL RESPONSIBILITY ACTIVITIES

Every year Recordati supports a number of associations dedicated to assisting sickpeople, to the improvement of patients’ quality of life, and to new research projects.Social, cultural and environmental institutions who operate seriously and with passion on a daily basis are generously assisted.

During 2019 the Recordati group donated approximately € 3 million to foundations, associations,

non-profit organizations and medical institutions.

Recordati supports institutions which offer socially useful services and assistance, for example

food and clothing for the homeless in Ireland as well as participating in the «Earth Day Clean Up»,

or in Germany where some services have been sourced out to the handicapped.

THE RECORDATI GROUP’S STAKEHOLDERS

INVESTORS AND THE

FINANCIAL COMMUNITY

EMPLOYEES

GOVERNMENT AGENCIES,

REGULATORS, PA

SUPPLIERS AND

STRATEGIC PARTNERS

PHARMACIES AND

DISTRIBUTORS

LOCAL

COMMUNITIES

PATIENTS AND ASSOCIATION

HEALTHCARE OPERATORS

SCIENTIFIC

ORGANISATIONS AND UNIVERSITIES

CLIENTS

AND CONSUMERS

30 |

| 31SUSTAINABILITY FOR THE RECORDATI GROUP

VITTORE BUZZI CHILDREN’S HOSPITAL IN MILAN

Thanks to works entirely financed and directed by Recordati, in November 2019 the Vittore Buzzi Children’s Hospital in Milan opened a new Paediatric Ward and renovated the Paediatric Neurology Outpatient Clinic area with rooms specially designed to be child-friendly, also in terms of colours and furnishings.The operation, strongly supported by Recordati, involved a disbursement of approximately € 1.9 million and was dedicated to the memory of Giovanni Recordati. Thanks to the new arrangement, the Paediatric and Paediatric Neurology departments have expanded and differentiated the treatment options for children with acute and chronic developmental neurological diseases.Specifically, the Paediatrics Multiple Operating Unit (UOC), with the opening of the new Single Operating Unit (UOS) Paediatric Ward has 18 new beds, bringing the total number of beds for ordinary hospitalisation up to 38. It will be better able to respond to the growing demand for emergency hospitalization and to implement care and treatment pathways, in scheduled hospitalization regime, for children suffering from chronic/complex disorders who need specialized or ultra-specialized and multidisciplinary assistance.The introduction of two Paediatric Neurology inpatient beds at the new Single Operating Unit (UOS) of the Paediatric Ward and a dedicated area set up in this area with state-of-the-art equipment, will make it possible to treat the main acute and chronic neurological, paediatric diseases.

THE COMMITMENT OF RECORDATI TO IMPROVE ACCESS TO TREATMENTS FOR RARE DISEASES AND MEDICAL ASSISTANCE

Recordati shares the principle that every person affected by a rare disease has the right to the best treatment possible and in addition to supporting patient associations and collaborating actively with the medical community to spread the scarce knowledge available, it has developed two separate programmes to provide assistance to patients eligible for financial support for their products in the U.S.A.: the Patient Assistance Program (PAP), valid for all products, and the Co-Pay Assistance Program (CAP).

| 31

SUSTAINABILITY IN FIGURES

MORE THAN € 1.2 BILLION

of economic value generated and distributed by the Group in 2019.

93.5%

of employees hired on permanent contracts.

-11%

reduction in water consumption at production facilities compared to 2018.

APPROXIMATELY € 3 MILLION

disbursed in donations and contributions in 2019*.

APPROXIMATELY 32 GWH**

of electricity purchased is obtained from renewable sources and certified by Guarantees of Origin.

45%

of the Group’s workforce represented by women.

MORE THAN 110.000 HOURS

of total training provided to employees in 2019.

APPROXIMATELY -6%

tons of CO2 emitted (Scope 2 Location based) by the Group’s production plants in 2019.

166 AUDITS

carried out on suppliers to ensure product quality and security.

* In 2019, as well as € 1.64 million disbursed in donations and contributions to foundations, associations, non-profit organisations and medical institutions, the Group also paid out approximately € 1.3 million of the amount allocated in 2017 to the “V. Buzzi” Children’s Hospital in Milan.

** Electricity produced from renewable sources, purchased for the Milan plants and for the Campoverde plant in Aprilia, certified by Guarantees of Origin.

THE RECORDATI GROUP IN THE COVID-19 EMERGENCY

Alongside the community in which it operates, right from the beginning, the Recordati group allocated € 5 million to contribute to the support of hospitals and health facilities in their fight against the epidemiologic emergency due to COVID-19 and promptly responded to requests from the Lombardy Region to counter the shortage of antiviral drugs and medicines for obstructive disorders of the respiratory tract by donating 58,920 packs of its own products.

We believe that to contribute to the well-being of the community and allocate a part of our funds to charitable works is not simply a company formality or a professional duty, but rather a moral imperative. It is an imperative which we feel to be an essential part of a healthy company that is not only able to grow, but also at the same time to support and develop the community in which it operates and to give pride to those who work in it.

Andrea Recordati

SUSTAINABILITY FOR THE RECORDATI GROUP32 |

The Prize is an international award which aims to promote scientific research.

An award of 100,000 euros is granted to a scientist in recognition

for outstanding work in a particular area of research.

The winner is chosen by a Jury composed of experts

with high international standing.

The 2019 Award was dedicated to the promotion

and recognition of excellence in the research

of treatments for rare diseases.

The Arrigo Recordati International Prize for Scientific Research was established in the year 2000 in memory of the Italian pharmaceutical entrepreneur Arrigo Recordati who strongly believed in the power of research to drive the development of the pharmaceutical industry and provide products beneficial to public health.

THE ARRIGO RECORDATI INTERNATIONAL PRIZEFOR SCIENTIFIC RESEARCH

THE 2019 PRIZEThis prestigious prize was awarded to Professor Alberto Auricchio, MD, Coordinator of the Molecular Therapy Program at the Telethon Institute of Genetics and Medicine (TIGEM) and Professor of Medical Genetics at the Department of Advanced Biomedicine, «Federico II» University of Naples, on September 4 during the SSIEM (Society for the Study of Inborn Errors of Metabolism) Congress in Rotterdam. His project was dedicated to research on «Gene therapy of Stargardt disease - the most common inherited macular degeneration in humans - with AAV intein vectors».

SUSTAINABILITY FOR THE RECORDATI GROUP | 33

34 | RECORDATI

PHARMACEUTICAL CHEMICALS

Recordati uses a broad range of technologies to

produce competitively maintaining the highest

quality standards.

RECORDATI’S PHARMACEUTICAL

CHEMICALS BUSINESS FOCUSES ON: satisfying the requirements of the pharmaceuticals business,

striving for maximum product quality,

strengthening its presence in highly regulated markets

(the United States, Europe and Japan),

safety of production processes,

protection of the environment,

health and safety in the workplace.


(Geographical breakdown of 2019 revenues)

38.6% Europe

32.6% Australasia

26.2% America

2.6% Africa

34 |

| 35PRODUCTION SITES


PHARMACEUTICAL CHEMICAL PLANTS

Recordati’s pharmaceutical chemical production sites are equipped with modern plant and their

research laboratories are fitted with the latest equipment.

The Recordati group has a number of production sites: two dedicated to the production of pharmaceutical chemicals, six for pharmaceutical manufacturing and one for the packaging and distribution of treatments for rare diseases.

CAMPOVERDE DI APRILIA (ITALY)

❱ This plant is one of the most important producers in the world of verapamil HCl, phenytoin, papaverine HCl, dimenhydrinate, tribenoside and manidipine.

❱ In addition to supplying the active ingredients for the group’s proprietary specialties, it is also an established independent producer of active ingredients and intermediates for the pharmaceutical industry internationally.

PRODUCTION SITES

❱ The United States is one of the main markets for its production second only to Europe.

❱ The site covers a surface of 335,000 sq. m with a covered area of 35,000 sq.m., it produces approximately 650 MT/year of finished goods, it handles internally approximately 5,000 MT/year of semi-finished goods are handled internally.

❱ A vast range of competencies in the field of organic synthesis allow it to quickly and effectively study

| 35

36 | PRODUCTION SITES

new processes from research right through to final industrialization.

❱ The Research and Development laboratories are fitted with an extremely versatile pilot plant equipped for the small scale production, in accordance with cGMP (current Good Manufacturing Practices), of active ingredients.

❱ Investments have been made to enhance the technological and production capacity of the plant which over the last 7 years has resulted in the installation of more than 20 new reactors, a latest generation three stage distillation unit, 2 thin film evaporators and a new anti-acid filter for the isolation of solid products.

❱ It operates in compliance with current Good Manufacturing Practices (cGMP) and in conformity with the most stringent international environmental regulations. The Plant Environmental Management System is certified according to the UNI EN ISO 14001:2004:2015 by Det Norske Veritas Italia (DNV).

CORK (IRELAND)

❱ A dedicated plant built in Cork in Ireland to guarantee adequate and continuous supplies of the active ingredient lercanidipine, an important original Recordati drug.

❱ Automated process control systems ensure constant high quality production.

❱ It operates in accordance with GMP (Good Manufacturing Practices) and covers a surface area of around 43,000 sq. m, with an installed area of 8,300 sq. m..

❱ It received the 2012 National Energy Efficiency Award which is promoted by the sustainable Energy Authority of Ireland (SEAI) and in 2013 received the European Energy Efficiency Award promoted by the Chemical European Federation Industry Council (CEFIC).

❱ In 2016 the site was extended, the two buildings housing the administration and the quality control laboratories were enlarged.

36 |

| 37PRODUCTION SITES

PHARMACEUTICAL MANUFACTURING PLANTS

Recordati’s six pharmaceutical production facilities all operate in full compliance with environmental

protection regulations and with current Good Manufacturing Practices (cGMP).

ITALY

The Milan site occupies a surface area of around 5,000 sq. m., built vertically over a number of floors for a total of 21,000 sq. m. and produces around 62 million packages per year. It is specialized in the manufacture and packaging of solid oral forms, liquids, injectables and products for topical use.

FRANCE

The plant at Saint Victor (France) covers a surface of 6,750 sq. m. and produces 33 million packs per year.

It is specialized in the production and packaging of liquid, solid oral and spray formulations.

TURKEY

The Turkish site in Çerkezköy, built on 45,000 sq. m. of land, occupies a surface area of approximately 11,300 sq. m. and currently produces 66 million packages per year of solid oral and liquid formulations and products for topical use, of which 20% is dedicated to third party production. The plant has a production capacity of 80 million packs per year.

SPAIN

The Spanish plant is situated near Zaragoza covering a surface area of 7,100 sq. m. and produces around 19 million packs a year. It is specialized in the production

| 37

38 | PRODUCTION SITES

and packaging of solid and liquid oral and topical formulations.

In particular, the plant manufactures a line of gastroenterological products. Recently, a project was approved for the installation of a new line for the packaging of tablets in bottles which will increase the annual volumes by around 7-8 million packs.

TUNISIA

The Tunisian plant is situated in Ariana, near Tunis. It covers an area of around 9,100 sq. m. and produces around 17 million packs a year of liquid, semi-solid and oral solid forms for the local market and for some of the countries in the Arabian Peninsula.

CZECH REPUBLIC

The plant in the Czech Republic, situated in Pardubice, produces creams, gels and ointments for a total of 2 million packages per year, some of which for third parties.

PACKAGING AND DISTRIBUTION CENTRE DEDICATED TO PRODUCTS FOR RARE DISEASES

A new distribution site in Paris exclusively destined to products for the treatment of rare diseases. It occupies a surface area of 1,200 sq. m. and is entirely dedicated to the packaging, storage and shipping of rare disease products. An area of 400 sq.m. is office space. The site delivers, upon short notice, more than 27,000 orders annually to more than 60 countries worldwide thanks to its highly qualified staff and a modern GMP (Good Manufacturing Practices) certified logistics platform.

38 |

| 39RECORDATI

THE RECORDATI SHARE

THE RECORDATI SHARE AT 31 DECEMBER 2019

Listing: Borsa Italiana, Blue Chip segment, healthcare

ISIN Code: IT 0003828271

Ticker: Bloomberg REC IM, Reuters RECI.MI

Index: FTSE MIB FTSE Italia All-Share Pharmaceuticals & Biotechnology Index STOXX Europe 600 Health Care, MSCI ICB Code 4570

Share Capital: n. 209,125,156 common shares

Nominal value: € 0.125 per share

EPS (diluted): € 1.764

Dividend per share: € 1.00

PRINCIPAL SHAREHOLDERS

(2019)

Recordati is listed on the Italian Stock Exchange (London Stock Exchange group) since 1984.

1.6% Treasury Stok

51.8% Consortium of investment funds controlled by CVC Capital Partners

46.6% Free Float

DIVIDEND (per share)

€ 0.27 € 0.30 € 0.30 € 0.33

€ 0.50

€ 0.60

€ 0.70

€ 0.85€ 0.92

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

€ 1.00

| 39

Produced by: Recordati S.p.A.Concept and graphic design: Graphicamente MilanoPhotos: Archivio Recordati, Niccolò Biddau, Riccardo Sarri, David Fisher Creative Service, Shutterstock images

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THE GROUP’S OFFICESITALYRECORDATI S.p.A.INNOVA PHARMA S.p.A.ITALCHIMICI S.p.A.Via M. Civitali, 1 - 20148 Milan Ph. +39 02 48787.1 Fax +39 02 40073747 www.recordati.itChemical pharmaceuticals plant: Via Mediana Cisterna, 4 04011 Campoverde di Aprilia (LT) Ph. +39 06 92900010 Fax +39 06 92904406NATURAL POINT S.r.l. Via Pompeo Mariani, 4 - 20128 Milan Ph (+39) 02 27007247 Fax (+39) 02 26005099 www.naturalpoint.itRECORDATI RARE DISEASES Italy S.r.l. Via M. Civitali, 1 - 20148 Milan Ph. +39 02 4878 7173 Fax +39 02 4878 7174 www.recordatirarediseases.com Email: [email protected] AUSTRALIARECORDATI RARE DISEASES AUSTRALIA PTY Ltd Level 6, 69 Reservoir Street Surry Hills, Sidney New South Wales 2010 Ph. +61 (0) 2 8218 2115 www.recordatirarediseases.com Email: [email protected] BRASILRECORDATI RARE DISEASES COMERCIO DE MEDICAMENTOS LTDA Av. Piraíba, 296 - 9 - Parte B - Centro Comercial Jubran 06460-121 Barueri - São Paulo Ph. +55 11 4414-5851/5852 www.recordatirarediseases.com Email: [email protected] BENELUXRECORDATI BV or SRL Avenue du Bourgmestre Demunter 5, 1090 Jette, Belgium Tel: +32 2 461.01.36 Fax +32 2 461 02 36 www.recordati.com Email: [email protected] BULGARIARECORDATI BULGARIA Ltd 84 “Al. Stamboliiski” Blvd, Floor 8, Office No. 44 - 1303 Sofia Ph. +359 2 829 39 37 Mob. +359 877 784 500 www.recordati.com Email: [email protected] CANADARECORDATI RARE DISEASES CANADA Inc. 3080 Yonge Street, Suite 6080 Totonto, Ontario - Canada M4N 3N1 Ph. +1 647 255 8830 Fax +1 647 255 8801 www.recordatirarediseases.com/ca Email: [email protected] COLOMBIARECORDATI RARE DISEASES COLOMBIA S.A.S. Carrera 7 N° 127 – 48 Oficina 901 Edificio 128 Centro Empresarial Bogotá D.C. Ph. +57 1 6472780 – 57 1 6474316 www.recordatirarediseases.com Email: [email protected]

CZECH REPUBLIC AND SLOVAKIAHERBACOS RECORDATI S.R.O. Kutnohorská 11/57 109 00, Praga 10 - Dolní Mêcholupy Ph. +420 227 200 722 Fax +420 227 200 777 www.recordati.cz Email: [email protected] FRANCEBOUCHARA-RECORDATI S.A.S.LABORATOIRES BOUCHARA RECORDATI S.A.S.TONIPHARM S.A.S.Immeuble “Le Wilson” 70, avenue du Général De Gaulle 92800 Puteaux Ph. +33 1 45191000 Fax +33 1 47560246 www.recordati.comProduction plant: Parc Mécatronic - 03410 Saint Victor Ph. +33 4 70037900 Fax +33 4 70037890RECORDATI RARE DISEASES SARL Immeuble “Le Wilson” 70, avenue du Général De Gaulle 92800 Puteaux Ph. +33 1 47 73 64 58 Fax +33 1 49 00 18 00 www.recordatirarediseases.com Email: [email protected] GERMANYRECORDATI PHARMA GmbH Eberhard-Finckh-Str. 55 - 89075 Ulm Ph. +49 731 7047.0 Fax +49 731 7047.297 www.recordati.deRECORDATI RARE DISEASES GmbH Eberhard-Finckh-Str. 55 89075 Ulm, Germania Ph. +49 731 140 554 0 Fax +49 731 140 554 99 www.recordatirarediseases.com Email: [email protected] JAPANRECORDATI RARE DISEASES JAPAN KK 1-10-2, Ichibancho, Chiyoda-ku, Tokyo, 102-0082 Ph. +81 3 4510 2910 Fax +81 3 4510 2911 www.recordatirarediseases.com Email: [email protected] GRECIARECORDATI HELLAS PHARMACEUTICALS S.A. 7, Zoodochou Pigis str 15231 K. Chalandri, Atene Ph. +30 210 6773822 Fax +30 210 6773874 www.recordati.com IRELANDRECORDATI IRELAND Ltd Raheens East Ringaskiddy Co. Cork Ph. +353 21 437 94 00 Fax +353 21 437 92 64 www.recordati.com

MIDDLE EASTRECORDATI RARE DISEASES MIDDLE EAST FZ-LLC Dubai Healthcare City Building 25, Unit 206, P.O. Box 505075 Dubai, UAE Ph. +971 4 363 5454 Fax +971 4 363 5453 www.recordatirarediseases.com Email: [email protected] MESSICORECORDATI RARE DISEASES S.A. de C.V. Av. Insurgentes Sur #1647 Piso 4, Oficina 421 Colonia San José Insurgentes, Benito Juárez C.P. 03900 Distretto Federale, Messico Ph. +525526140975 www.recordatirarediseases.com Email: [email protected] POLSKARECORDATI POLSKA SP. Z O.O. Ul. Królewska, 16 - 00-103 Varsavia Ph. +48 22 206 84 50 www.recordatipolska.pl PORTUGALJABA RECORDATI S.A.CASEN RECORDATI PORTUGAL UNIPESSOAL LDABONAFARMA - PRODUTOS FARMACÊUTICOS S.A.JABAFARMA - PRODUTOS FARMACÊUTICOS S.A.Av. Jacques Delors Ed. Inovação 1.2, Piso 0 - Taguspark 2740-122 Porto Salvo Ph. +351 21 4329.500 Fax +351 21 9151.930 www.jaba.pt ROMANIARECORDATI ROMANIA S.R.L. 92-96 Izvor street, Forum III Building, Office B, 4th floor, Rooms 2-8, 5th District, Bucarest Ph. +40 21 667 17 41 - 2 Fax +40 31 405 57 42 www.recordati.ro RUSSIA AND C.I.SFIC MEDICAL S.a.r.l. Immeuble “Le Wilson” 70, avenue du Général de Gaulle 92800 Puteaux, Francia Ph. +33 1 45 19 11 00 Fax +33 1 45 19 10 83 RUSFIC LLC Area №IAZH, 6 floor, 7 entrance, WTC Krasnopresnenskaya Naberezhnaya 12 Moscow, Russian Federation, 123610 Ph. +7 495 2258 001 Fax +7 495 2582 007Primary and specialty care: www.rusfic.ru Email: [email protected] Diseases: www.recordatirarediseases.com Email: [email protected]

SPAINCASEN RECORDATI S.L. Vía de las Dos Castillas, 33 3° Ática Edificio 7 28224 Pozuelo de Alarcòn, Madrid Ph. + 34 91 351 88 00 Ph. + 34 91 659 15 50 Fax + 34 91 351 87 99 www.casenrecordati.com

Production plant: Autovía Logroño, km. 13.300 50180 Utebo, Zaragoza Ph. + 34 97 646 26 26 Fax + 34 97 677 15 60 SWEDENRECORDATI AB Jan Stenbecks Torg 17 S - 16440 Kista, Svezia Ph. +46 8 545 80 230 Fax +46 8 660 50 78 SWITZERLANDRECORDATI AG Lindenstrasse, 8 - 6340 Baar Ph. +41 41 769.1000 Fax +41 41 769.1007 Email: [email protected] AG, RARE DISEASES BRANCH Uferstrasse, 90 4057 Basilea Ph. + 41 61 205 61 00 www.recordatirarediseases.com TUNISIAOPALIA PHARMA S.A.OPALIA RECORDATI SARLZ.I. Kalaat El Andalous - 2022 Ariana Ph. +216 70 559 070-064 Fax +216 70 559 184 www.opalia-pharma.com Email: [email protected] TURKEYRECORDATI ÍLAÇ ve Hammaddeleri Sanayi ve Ticaret A.S. Maslak Mahallesi. Sümer Sokak, Maslak Office Building No: 4 Kat: 5-6 34398 Maslak Sarıyer/ Istanbul Ph. +90 212 401 91 00 Fax +90 212 401 91 10 www.recordati.com.trPharmaceutical plant: Çerkezköy Organize Sanayi Bölgesi Karaağaç Mahallesi Atatürk Caddesi No:36 Kapaklı, 59510 Tekirdağ Istambul Ph. +90 282 999 16 00 Fax +90 282 999 16 61 UKRAINERECORDATI UKRAINE LLC 40, Hlybochytska Str. - Kyiv 04050 Ph. +380 44 351 18 63 Fax +380 44 351 18 64 www.recordati.com UNITED KINGDOMRECORDATI PHARMACEUTICALS Ltd Origin, Western Road Bracknell RG12 1US Ph. +44 1 49 1576 336 Email: [email protected] USARECORDATI RARE DISEASES Inc. 100 Corporate Drive, Suite 104 Lebanon, NJ 08833 Ph. +1 908 236 0888 Fax +1 908 236 0028 www.recordatirarediseases.com Email: [email protected]

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