COMPANY PROFILE - Menarini Group

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COMPANY PROFILE - Menarini Group
COMPANY PROFILE
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                                             Menarini was
                                             founded in 1886.
                                             In 1915 its headquarters
                                             were established
                                             in Florence.

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                                                                                    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.

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                                                                                        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.

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                                                                                                        Consolidated turnover
                                                                                                                                        Million euro
                                                                                                                                                                               3,750
                                                                      4.000

                                                                                        Menarini ranking*                                                              3,527
                                                                      3.500

                                                                                        32nd Global position                                                   3,212
                                                                      3.000
                                                                                        15th European position                                         2,620

                                                                      2.500

                                                                                                                                          1,869
                                                                      2.000

                                                                                                                                1,306
                                                                      1.500

                                                                      1.000
                                                                                                                         794

                                                                       500
                                                                                              1                     13
                                                                         0

                                                                                          1964                   1978    1992   2000      2004         2008    2012    2016      2020
                                             Source: internal data.     *Source : Iqvia WRMP 12/2020 - Retail Market.

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                                                                                Consolidated turnover
                                                      Pharmaceutical 92%                          Abroad 76%

                                                                      Diagnostic 7%    Other 1%                            Italy 24%
                                             Source: internal data.

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                                                  Menarini in the WORLD
                                             Present in 140   countries worldwide (with its affiliates, distributors and franchises).

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                                             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.

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                                             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.

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                                             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.

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                                             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.

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                                             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

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                                                                             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.

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                                             Employees % of graduates and technicians
                                                    100
                                                                        91%
                                                    90

                                                    80           72%
                                                     70

                                                    60

                                                    50

                                                    40

                                                    30

                                                    20
                                                          10%
                                                     10

                                                     0

                                                          1964   1990   2020

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                                                                                                                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.

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                                             10 Research & Development centres
                                                                                 915 employees

                                                                         Barcelona      Florence
                                                            New York                    Pisa     Rome
                                                                                                   **

                                                          Philadelphia         Berlin   Siena Bologna
                                                                                            *
                                                                                                        Singapore

                                             * Rapolano. **Pomezia.

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                                             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)                                                     Breast cancer                                                           Phase III

                                                           SL-701                                                          IT (IL-13Rα2, EphA2, Survivin)                                Glioblastoma Multiforme                                                 Phase II

                                                           MEN1703                                                         SME (PIM/FLT3i)                                               Acute myeloid leukaemia                                                 Phase II

                                                           MEN1611                                                         SME (PI3Ki)                                                   Breast cancer                                                           Phase Ib

                                                           MEN1611                                                         SME (PI3Ki)                                                   Colorectal cancer                                                       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.

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                                              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
                                                         Delafloxacin                                        Anionic fluoroquinolone
                                                                                                                                         Structure - ABSSSI
                                                                                                                                                                                     EMA and FDA: approved

                                                                                                                                         Community Acquired
                                                         Delafloxacin                                        Anionic fluoroquinolone
                                                                                                                                         Bacterial Pneumonia - CABP
                                                                                                                                                                                     EMA and FDA: approved

                                                                                                                                         Acute Bacterial Skin and Skin
                                                         Oritavancin                                        Semisynthetic glycopeptide
                                                                                                                                         Structure - ABSSSI
                                                                                                                                                                                     EMA and FDA: approved

                                                                                                                                         Acute Bacterial Skin and Skin
                                                         Oritavancin                                        Semisynthetic glycopeptide
                                                                                                                                         Structure - ABSSSI
                                                                                                                                                                                     Phase Ib (new formulation)

                                             *On April 2021, Delafloxacin has been approved in EU for the for the treatment of CABP.

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