A Trusted Partner for Pharmaceutical Industry Leaders Corporate Presentation
An Independent API Company You Can Trust A world-class developer and manufacturer of differentiated Active Pharmaceutical Ingredients Global Presence - More than 250 customers in over 50 countries Customer oriented – We are on the same wavelength , always in tune with the results required to support your needs 32 years of exceptional regulatory track record with leading global regulatory authorities (USFDA, EU-EMA, PMDA, TGA, KFDA, ANVISA and COFEPRIS) Scale – More than 250 metric tons of API produced every year Strong expertise in complex chemistry, innovative process development, crystalline forms and particle design Leading R&D capabilities and strong regulatory expertise – 198 DMFs worldwide API CDMO services from pre-clinical grams to multi ton commercial scale Customized solutions to meet individual customer requirements Creative business models to get to market, including co-development partnerships Long heritage of excellence, and global leadership in select molecules 2
Over 30 Years of Service Acquired by SK Capital Perrigo Renamed Founded 1987 2017 2005 2013 Renamed Wavelength acquires Perrigo API in Israel Pharmaceuticals Agis 3
New Ownership – Renewed Focus A New York based transformational private investment firm with a disciplined focus on the pharmaceuticals and specialty chemicals sectors $4.6B portfolio , 12 companies generating aggregate annual revenues of $9B , employing +10,000 people globally, with 86 plants operating across 24 countries, selling to customers in 115 countries Vast industry and operating experience, augmenting leadership teams with strong talent to transform businesses into higher performing standalone customer-centric organizations Building strong and growing businesses that create substantial long-term value with improved strategic positioning as well as lower operating risk 4
Leadership Team 5
Management Team CEO Iftach Seri Head of BD Head of Operations Marketing & IP Amit Kalimi Ilan Avni CFO Head of R&D Tami Cohen Benzion Dolitzky Head of Quality, Head of HR Regulatory & Liat Mayan Compliance Sarah Isaacs 6
Board of Directors Chairman Aaron Davenport Itzhak Iftach Seri Krinsky Arik Yaari Barry Penney Stephen Meron Mann d ’ Incelli 7
Working with Us is Always an Advantage
Committed to Quality Strict compliance with the most stringent cGMP standards of all key global regulatory bodies Highly experienced team of over 80 quality assurance and quality control personnel Consistent supply of high quality APIs since 1987 Over 100 successful customer and health authorities audits in the past 5 years Israeli MoH audit in Feb 2019 - mutually recognized by the EU as EU GMP (no observations) USFDA audit in Jul 2018 (no 483s) 9
Wavelength Pharmaceuticals - A Partner You Can Trust 10
Global Presence - More than 250 customers in over 50 countries >80% of sales in US, EU & Japan NJ USA NA Sales Office India R&D Wavelength Sites Spain EU Sales Market Presence Office Israel Head Office Production R&D 11
API Contract Development and Manufacturing Services Technology Transfer Process Development Analytical Methods Development Synthesis of Impurities and Standards Potential Genotoxic Impurities Evaluation including High Sensitivity Analytical Methods Suppliers Qualification Solid State / Polymorphism Research Characterization of Physical Properties Particle Design Process Optimization cGMP scale Up Process Validation Stability Studies Full cGMP Documentation & DMF Compilation cGMP Manufacturing - Grams to Multi Ton Scale 12
People Are Key To Our Success G&A 10 Sales and 15 Marketing PhD 23 R&D 70 350 FTE MSc 35 Quality 80 Chemical Operation 175 42 Engineers
Leading R&D Capabilities and Strong Regulatory Expertise 70 R&D scientists and 10 regulatory experts in Israel and India Strong expertise in complex chemistry, innovative process development, crystalline forms and particle design Quality by design and complete regulatory support throughout the product lifecycle Extensive knowhow and experience in filing Drug Master Files with many different agencies, enables us to provide best-in-class regulatory support for our customers in various markets United States 32 USDMF Europe 28 EDMF 13 CEP Japan 11 JDMF Korea 7 KDMF Rest of World 120 Total 198 DMFs 14
World-Class Manufacturing Facility Located in the Neot Hovav Eco Industrial Park in Israel Wide range of multi-purpose production capabilities from grams scale to multi-ton commercial quantities Complex chemical reactions and advanced pharmaceutical technologies Highly potent compounds, steroids and cytotoxics manufacturing capabilities complying with the strictest containment requirements (OEB 4, <1µg/m 3 ) Ability to quickly and efficiently meet our customers ’ production needs translates into lower risk, faster turnaround, and unparalleled quality 15
Environmental and Social Responsibility Committed to the highest Environment Protection, Health and Safety standards Implementing Best Available Technologies across the following field of operations: Waste treatment Gas Emission Reduction Energy Efficiency Participating in multiple voluntary community programs with focus on education and health 16
A Wide Range of Products
A Wide Range of API Products New Products API Therapeutic Use Available DMFs Efinaconazole Onychomycosis of the toenail or fingernail USDMF Fluticasone Furoate Seasonal and perennial allergic rhinitis , COPD USDMF Ibrutinib Mantle cell lymphoma, Chronic lymphocytic leukemia USDMF Rotigotine Parkinson’s disease USDMF Sugammdex Antidote for Vecuronium and Rocuronium USDMF under preparation Tavabarole Onychomycosis of the toenail or fingernail USDMF Tiotropium Bromide Monohydrate COPD USDMF, CEP, CDMF Commercial Products API Therapeutic Use Available DMFs Ammonium Lactate Ichthyosis and Xerosis USDMF Anastrozole Breast cancer CEP, KDMF Cetirizine Dihydrochloride Seasonal and perennial allergic rhinitis USDMF, CEP, JDMF, CADMF Cilostazol Reduction of symptoms of intermittent claudication USDMF, JDMF, KDMF, BRDMF USDMF, CEP, CADMF, BRDMF, Cisatracurium Besylate Neuromuscular blocking agent AUDMF Donepezil Base Alzheimer’s -type dementia USDMF, CEP, KDMF Donepezil Hydrochloride Alzheimer’s -type dementia USDMF, CEP, JDMF 18
A Wide Range of API Products Commercial Products (continued) API Therapeutic Use Available DMFs Fenofibrate Hyperlipidemia; Hypertriglyceridemia USDMF, CEP, CADMF Fexofenadine Hydrochloride Allergy symptoms USDMF Flumazenil Reversal of sedative effects of benzodiazepines USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF Fluticasone Propionate Asthma, COPD USDMF, CEP, JDMF, KDMF, CADMF, BRDMF Fulvestrant Breast Cancer USDMF, CEP Granisetron Base Chemotherapy-induced nausea and vomiting USDMF Granisetron Hydrochloride Chemotherapy-induced nausea and vomiting USDMF, CEP, JDMF, KDMF, CADMF Halobetasol Propionate Topical anti-inflammatory and antipruritic conditions USDMF Imiquimod Actinic keratoses (AK); Superficial basal cell carcinoma; USDMF Genital and perianal warts/condyloma Midazolam Sedation; Amnesia; Anesthesia USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF Modafinil Excessive sleepiness associated with narcolepsy, USDMF, CEP, BRDMF, AUDMF obstructive sleep apnea, and shift work disorder Mometasone Furoate anhydrous Asthma USDMF 19
A Wide Range of API Products Commercial Products (continued) API Therapeutic Use Available DMFs Mometasone Furoate Allergic Rhinitis USDMF, EDMF, CADMF, BRDMF, CDMF monohydrate Moxonidine Hypertension CEP Omeprazole Magnesium Duodenal and gastric ulcer; Gastroesophageal reflux disease USDMF (GERD) Palonosetron Hydrochloride Chemotherapy-induced nausea and vomiting; Post-operative USDMF, EDMF, JDMF nausea and vomiting Permethrin Treatment for scabies USDMF, CEP Pramipexole Base Parkinson’s disease USDMF Pramipexole Dihydrochloride Parkinson’s disease USDMF, BRDMF Rocuronium Bromide Adjunct to general anesthesia USDMF, KDMF, CADMF Temozolomide Glioblastoma multiforme (GBM) USDMF, EDMF, CADMF, BRDMF Terbinafine Hydrochloride Onychomycosis of the toenail or fingernail JDMF, BRDMF Tramadol Hydrochloride Management of moderate to moderately severe pain USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF 20
A Wide Range of API Products Under Development API Therapeutic Use Calscoterone Acne / Alopecia Glycopyronuim Bromide Chronic obstructive pulmonary disease (COPD) Remimazolam Sedation, Anesthesia Sitagliptin Phosphate Type II Diabetes Vilanterol Trifenatate Chronic obstructive pulmonary disease (COPD) Under Evaluation API Therapeutic Use Brexanolone Postpartum Depression Entinostat Breast Cancer Ganaxolone Epilepsy, Postpartum Depression Indacaterol Maleate Chronic obstructive pulmonary disease (COPD) Istradefyline Parkinson’s Disease Lumateperone Schizophrenia Roluperidone Schizophrenia Sarizotan Rett Syndrome Umeclidinium Bromide Chronic obstructive pulmonary disease (COPD) 21
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