a trusted partner for pharmaceutical industry leaders€¦ · over 30 years of service. 3. 1987....
TRANSCRIPT
Corporate Presentation
A Trusted Partner for Pharmaceutical Industry Leaders
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
33 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, process optimization and scale up, 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
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Over 30 Years of Service
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1987 2005 2013 2017Founded in Israel
Perrigo acquires
Agis
Acquired by SK Capital Renamed Wavelength
Pharmaceuticals
Renamed Perrigo API
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
New Ownership – Renewed Focus
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Leadership Team
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Management Team
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CEOIftach Seri
CFOTami Cohen
Head of BDMarketing & IP
Ilan Avni
Head of R&DBenzion Dolitzky
Head of Quality, Regulatory & Compliance
Sarah Isaacs
Head of HRLiat Mayan
Head of OperationsAmit Kalimi
Global VP SalesFrédéric Kahn
Board of Directors
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ChairmanAaron Davenport
Arik Yaari
Meron Mann
Barry Penney
Stephen d’Incelli
Itzhak Krinsky Iftach Seri
Working with Us is Always an Advantage
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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)
Wavelength Pharmaceuticals - A Partner You Can Trust
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Global Presence - More than 250 customers in over 50 countries
Market PresenceWavelength Sites
NJ USANA Sales Office
IndiaR&D
IsraelHead OfficeProductionR&D
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>80% of sales in US, EU & Japan
SpainEU Sales Office
API Custom Development and Manufacturing Services
Technology TransferProcess DevelopmentEnzymatic Process DevelopmentAnalytical Methods DevelopmentSynthesis of Impurities and StandardsPotential Genotoxic Impurities Evaluation including High Sensitivity Analytical MethodsSuppliers Qualification Solid State / Polymorphism ResearchCharacterization of Physical PropertiesParticle Design Spray Drying & Bioavailability Enhancing Process Optimization cGMP scale UpProcess ValidationAnalytical Methods ValidationStability StudiesFull cGMP Documentation & DMF CompilationcGMP Manufacturing - Grams to Multi Ton Scale
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People Are Key To Our Success
350 FTE 175
80
70
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10
Operation
Quality
R&D
Sales andMarketing
G&A
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35
42
PhD
MSc
ChemicalEngineers
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
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32 USDMFUnited States
13 CEP28 EDMFEurope
11 JDMFJapan
7 KDMFKorea
120Rest of World
198 DMFsTotal
R&D Lab Analytical Instruments
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HPLC with various detectors (UV, DAD, RI, CAD, Conductivity, ELSD) 34
HPLC “Rapid” - Pressure up to 800bar 2GC HS - FID detector 12UV/VIS Spectrophotometer 2LCMS/MS (Q-TRAP) 1LCMS/MS equipped with Q-TOF MS detector 1
GCMS 1XRD 1SEM + coater 1DSC 1TGA 1DVS 1FTIR/Raman 2Light microscope 1Malvern Mastersizer 2000 1Malvern Mastersizer 3000 1
Glovebox 2Photostability chamber 2Stability chamber 2Karl Fisher Titrator 2Coulometric Karl Fisher Titrator 1Auto titrator 3Dissolution Chamber 1Mili Q water System 3Analytical Balance 10Halogen Moisture Analyzer 2Drying Oven / Vacuum Drying Oven 6Sympatec 1Sonication bath 2Sonication probe 1Balance 3BD/TD instrument 1Analytical sieving instrument 1
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 (OEL <1µg/m3)
Ability to quickly and efficiently meet our customers’ production needs translates into lower risk, faster turnaround, and unparalleled quality
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Environmental and Social Responsibility
Committed to the highest Environment Protection, Health and Safety standards
Implementing Best Available Technologies across the following field of operations:
Participating in multiple voluntary community programs with focus on education and health
Waste treatment Gas Emission Reduction Energy Efficiency
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A Wide Range of Products
A Wide Range of API Products
New Products
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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
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
Cisatracurium Besylate Neuromuscular blocking agent USDMF, CEP, CADMF, BRDMF, AUDMF
Donepezil Base Alzheimer’s-type dementia USDMF, CEP, KDMF
Donepezil Hydrochloride Alzheimer’s-type dementia USDMF, CEP, JDMF
Commercial Products
A Wide Range of API Products
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; Genital and perianal warts/condyloma
USDMF
Midazolam Sedation; Amnesia; Anesthesia USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF
Modafinil Excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder
USDMF, CEP, BRDMF, AUDMF
Mometasone Furoate anhydrous Asthma USDMF
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Commercial Products (continued)
A Wide Range of API Products
API Therapeutic Use Available DMFs
Mometasone Furoatemonohydrate
Allergic Rhinitis USDMF, EDMF, CADMF, BRDMF, CDMF
Moxonidine Hypertension CEP
Omeprazole Magnesium Duodenal and gastric ulcer; Gastroesophageal reflux disease (GERD)
USDMF
Palonosetron Hydrochloride Chemotherapy-induced nausea and vomiting; Post-operative nausea and vomiting
USDMF, EDMF, JDMF
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
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Commercial Products (continued)
A Wide Range of API Products
Under Development
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API Therapeutic Use
Clascoterone Acne, Alopecia
Remimazolam Sedation, Amnesia, Anesthesia
Cantharidin Molluscum Contagiosum
Sitagliptin HCl Type II Diabetes
Sitagliptin Phosphate Type II Diabetes
Glycopyrronium Bromide Chronic obstructive pulmonary disease (COPD)
Under EvaluationAPI Therapeutic Use
Ganaxolone Epilepsy, Postpartum Depression
Istradefyline Parkinson’s Disease
Indacaterol Maleate Chronic obstructive pulmonary disease (COPD)
Plinabulin Chemotherapy Induced Neutropenia
Relugolix Uterine Fibroids, Prostate Cancer
Umeclidinium Bromide Chronic obstructive pulmonary disease (COPD)
Vilanterol Trifenatate Chronic obstructive pulmonary disease (COPD)
Neot Hovav Site Tour
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Neot Hovav Eco Industrial ParkNeot Hovav Eco Industrial Park – Key Facts
1975Established
Area
Location
Facilities
Exports
Employees
Infrastructure
• 12km from Be’er Sheva• Close to Ben Gurion
University• 1.5hr drive from Tel Aviv
• 5,863 acres• 1,976 acres currently
occupied• 3,887 designated for
future industrial factories 23 factories & industrial facilities on siteTeva, Adama, ICL among tenants
4,000 employees across all factories & facilities
~$3B/ annum
• The park provides municipal services to all facilities and is responsible for infrastructure development and public spaces
• Development projects include shared evaporation ponds and a new visitors center
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Neot Hovav Eco Industrial ParkNeot Hovav Eco Industrial Park – Aerial Photo
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1 – Wavelength Pharmaceuticals2 – New Visitors Center3 – ICL4 – Adama5 – Teva Tech6 – Koffolk7 – Municipality of Neot Hovav8 – Ecosol 9 – Evaporation Ponds
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Wavelength Pharmaceuticals Neot Hovav Site
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14 211 7 3
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12 15 1610
1 – Production Plant 312 – Production Plant 373 – Production Plant 720 + 784 – Production Plant 41 + 455 – Production Plant 756 – Production Plant 76
Pilot Plant and R&D Labs7 – Biological Effluent
Treatment Plant8 – Utility Plant
9 – Raw Materials Warehouse10 – Final Product Warehouse11 – Air Treatment12 – R&D Labs13 – Available for Expansion14 – Scrap Yard / Available for
Expansion15 – QC labs16 – Main Entrance
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Looking Forward To Working With Youwww.wavelengthpharma.com