COMPANY PROFILE
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 1/17
Menarini was founded in 1886. In 1915 its headquarters were established in Florence.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 2/17 Milestones
1886 1964 1978 1992 2003
MENARINI INTERNATIONAL RESEARCH & CENTRAL AND MENARINI FOUNDATION PRESENCE DEVELOPMENT EASTERN EUROPE BIOTECH The internationalisation Menarini’s Research & Menarini acquires ex-GDR Opening of Menarini Biotech, of Menarini begins Development department company Berlin-Chemie specialised in the research, with the opening of opened and patents on thanks to which it makes its development and Laboratorios Menarini pharmaceuticals were entry into Germany and manufacturing of biotech in Spain , followed on by introduced. Central and Eastern Europe. pharmaceuticals , Greece, Portugal, Central from the lab to the patient. America and France.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 3/17 Milestones
2011 2013 2016 2020
ASIA SILICON CELLSEARCH U.S.A. PACIFIC BIOSYSTEMS Menarini makes its entry into Acquisition of Acquisition of Cell Search, Menarini makes its entrance into the Asia Pacific thanks to the Silicon Biosystems, an FDA approved technology USA thanks to the acquisition of acquisition of a company a start-up of in the field of circulating Stemline , biopharmaceutical based in Singapore and innovative technologies tumour cells. company publicly listed on NASDAQ, present in 13 countries for liquid biopsies. and their product Elzonris , the only throughout the region, from FDA approved therapy available for China to Australia. BPDCN, thus strengthening Menarini’s presence in oncology.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 4/17 Consolidated turnover Million euro 3,750 4.000 Menarini ranking * 3,527
3.500 32 nd Global position 3,212 3.000 15 th European position 2,620
2.500 1,869 2.000
1,306 1.500
794 1.000
500 1 13
0 1964 1978 1992 2000 2004 2008 2012 2016 2020
Source: internal data. *Source : Iqvia WRMP 12/2020 - Retail Market.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 5/17 Consolidated turnover
Pharmaceutical 92% Abroad 76%
Diagnostic 7% Other 1% Italy 24%
Source: internal data.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 6/17 Menarini in the WORLD Present in 140 countries worldwide (with its affiliates, distributors and franchises).
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 7/17 Western Europe
9,400 employees
Presence Florence - Italy (headquarters) , Austria, Belgium, Cipro, France, Germany, Greece, Ireland, Luxembourg, Portugal, Spain, Sweden**, Switzerland, Netherlands**, Turkey and United Kingdom.
Source: internal data. **Menarini Diagnostics presence.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 8/17 Central & Eastern Europe
3,400 employees
Presence Berlin (headquarters) , Albania, Armenia, Azerbaijan, Belarus, Bosnia&Herzegovina, Bulgaria, Czech Republic, Croatia, Estonia, Finland, Georgia, Hungary, Kazakhstan, Kyrgystan, Kosovo, Latvia, Lithuania, Moldova, Mongolia, Montenegro, North Macedonia, Poland, Romania, Russia, Serbia, Slovak Republic, Slovenia, Turkmenistan, Ukraine, Uzbekistan.
Source: internal data.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 9/17
Asia Pacific
3,600 employees
Presence Singapore (headquarters) , China, India, Australia, South Korea, Taiwan, Thailand, the Philippines, Indonesia, Vietnam, New Zealand, Hong Kong and Malaysia.
Distributors – Japan: Menarini Silicon Biosystems presence. Source: internal data.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 10/17
U.S.A.
acquisition June 2020
ELZONRIS ® For the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), (tagraxofusp) commercially available in the US. In Europe, on January 2021 Elzonris has been approved by the EMA as monotherapy for the first-line treatment of adult patients with BPDCN. Tagraxofusp is also being evaluated in other CD123+ indications, including chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF). Other products in Pipeline
SL-701 Immunotherapy in phase II for patients with glioblastoma multiforme. Felezonexor XPO1 inhibitor in phase I for patients with advanced solid tumors. SL-901 PI3K inhibitor in phase I for patients with solid tumors. SL-1001 RET kinase inhibitor in preclinical development. Location: New York, U.S.A.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 11/17 North America
Menarini Group’s lead company in the high-tech diagnostics area. The main instruments, DEPArray ™, Ampli 1 ™ and CELLSEARCH ® are used in personalized oncological therapies to find possible tumor mutations thoroughly and individually, and to determine the best therapy for the patient. All this from a simple blood sample.
Locations: Philadelphia, U.S.A. Bologna, ITALY
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 12/17 Number of employees
20.000 17,650
18.000
16.000
14.000 12,900
12.000
10.000 7,950
8.000
6.000 3,600 4.000
2.000 188
0 1964 1990 2000 2010 2020
Source: internal data.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 13/17
Employees % of graduates and technicians
91% 100
90
80 72%
70
60
50
40
30
20 10%
10
0 1964 1990 2020
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 14/17 18 production plants In 2020 these sites produced 572 million packs of pharmaceuticals products.
Ireland * Russia* Shannon Kaluga USA ** Spain Turkey * Indonesia* Philadelphia (Huntingdon Valley) Barcelona Istanbul Jakarta
* Italy Central America Germany Pisa (2 plants), Florence (2 plants and 1 plant under construction), Pomezia *** , L'Aquila , Guatemala City Berlin (2 plants), Dresda Lomagna (Lecco), Casaletto Lodigiano (Lodi), Rapolano (Siena) plant nearing completion
* Plants dedicated to production for local markets. ** Diagnostic production. ***Biotech manufacturing with development and production processes also for third parties.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 15/17 10 Research & Development centres 915 employees
Barcelona Florence New York Pisa Rome** Philadelphia Berlin Siena * Bologna Singapore
* Rapolano. **Pomezia.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 16/17
Research & Development Projects ONCOLOGY
COMPOUND DRUG CLASS (TARGET) INDICATION DEVELOPMENT STAGE Tagraxofusp (Elzonris ®) TB (CD123) Blastic plasmacytoid dendritic cell neoplasm EMA and FDA: approved Tagraxofusp TB (CD123) Chronic myelomonocytic leukemia Phase II Tagraxofusp TB (CD123) Myelofibrosis Phase II Elacestrant* SERD(ER) Breastcancer Phase III SL-701 IT (IL-13R α2, EphA2, Survivin) Glioblastoma Multiforme Phase II MEN1703 SME (PIM/FLT3i) Acute myeloid leukaemia Phase II MEN1611 SME(PI3Ki) Breastcancer Phase Ib MEN1611 SME(PI3Ki) Colorectalcancer Phase Ib MEN1112 mAB (Anti-CD157) Acute myeloid leukaemia Phase Ib MEN1309 ADC (Anti-CD205) Solid tumours Phase Ib Felezonexor SME (XPO1i) Solid tumours Phase Ib SL-901 SME (PI3Ki) Solid tumours Phase Ia SL-1001 SME (RETi ) Solid tumours Preclinical
*developed by Radius Health; TB, Targeted Biologic; SERD, Selective Estrogen Receptor Degrader; IT, Immunotherapy; SME, Small Molecule Entity; mAB, Monoclonal Antibody; ADC, Antibody Drug Conjugate.
CORPORATE PRESENTATION - NOT FOR PROMOTION COMPANY PROFILE 17/17
Research & Development Projects ANTI-INFECTIVES
COMPOUND DRUG CLASS INDICATION DEVELOPMENT STAGE
Complicated urinary tract infections, Meropenem + Carbapenem + Complicated Intra abdominal infections, EMA and FDA: approved Vaborbactam β-lactamase inhibitor Hospital acquired pneumonia, Ventilator associated pneumonia and Bacteremia Acute Bacterial Skin and Skin Anionic fluoroquinolone EMA and FDA: approved Delafloxacin Structure - ABSSSI
Community Acquired Anionic fluoroquinolone EMA and FDA: approved Delafloxacin Bacterial Pneumonia - CABP
Acute Bacterial Skin and Skin Semisynthetic glycopeptide EMA and FDA: approved Oritavancin Structure - ABSSSI
Acute Bacterial Skin and Skin Semisynthetic glycopeptide Phase Ib (new formulation) Oritavancin Structure - ABSSSI
*On April 2021, Delafloxacin has been approved in EU for the for the treatment of CABP.
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