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Hemmo Pharmaceuticals Private Limited Global Supplier of Quality Peptide Products Hemmo Pharmaceuticals Private Limited Corporate Presentation Privileged & Confidential Privileged & Confidential Corporate Overview Privileged & Confidential 2 Company at a glance • Commenced operations in 1966 as a Key Highlights trading house, focusing on Oxytocin amongst other products Amongst the largest Indian peptide manufacturing company • In 1979, ventured into manufacturing of Oxytocin Competent team of 154 people including 6 PhDs, 60+ chemistry graduates/post graduates and 3 engineers • Privately held family owned company Portfolio – Generic APIs, Custom Peptides for Research and Clinical Development and Peptide • Infrastructure Fragments − State of art manufacturing facility in Developed 21 generic products in-house. Navi Mumbai, 5 more in progress − R&D facilities at Thane and Spain − Corporate office at Worli First and the only independent Indian company to have a US FDA approved peptide manufacturing site Privileged & Confidential 3 Transition from a trading house to a research based manufacturing facility Commenced Commenced Investment in State of the Art Opened R& D Expanded operations manufacturing greenfield project facility at Navi Centre in manufacturing as a trading of peptides intended for Mumbai Girona,Spain capacity House regulated markets commissioned R&D center set up in Infrastructure Mumbai 1966 1979 2005 2007 2008 2010 2011 2012 2014 2015 Oxytocin Oxytocin Desmopressin Buserelin Triptorelin Goserelin Linaclotide Glatiramer amongst Gonadorelin Decapeptide Cetrorelix Bivalirudin Atosiban other Leuprorelin Carbetocin products Calcitonin Somatostatin Products Tetracosactide Terlipressin Octreotide Applications EEC Received Repeat EU Repeat US filed for US approval US FDA GMP audit FDA Audit DMF & CEP from approval cleared Germany Received without any Korean observation Approvals & Approvals 1st CEP FDA Certifications received approval Privileged & Confidential 4 Employee strength Head count by department Head count by qualification Head Count Department PhD 6 Turbhe Thane Spain MSc 76 Research & - 8 6 Development M.Pharm 1 Regulatory Affairs 2 - - Mcom 2 Quality Assurance 10 - - Quality Control 46 5 - MPM 1 Solution Phase BSc 17 21 - - Synthesis B.E. 3 Solution Phase 11 9 - Downstream B.Pharm 2 Solid Phase Synthesis 11 - - B.Tech 1 Solid Phase 17 - - Downstream B.Com 5 Maintenance 15 3 - B.A. 1 Administration 10 3 - Diploma 3 Stores 8 - - ITI PTL 3 - - 13 Canteen - 2 - Worker 59 Total 154 30 6 Privileged & Confidential 5 Product Portfolio Privileged & Confidential 6 Product Portfolio ACTH Tetracosactide Linaclotide Bivalirudin Somatostatin Glatiramer Octreotide Eptifibatide Oxytocin Carbetocin Atosiban Desmopressin Terlipressin Calcitonin Vasopressin Leuprolide Goserelin Gonadorelin Buserelin Triptorelin Cetrorelix Privileged & Confidential 7 Salient features India leadership ~18%+ revenue growth in most US DMF filed for Cater to 3/4th YTD peptides – Oxytocin, of the global Globally Desmopressin, demand for amongst top 5 Leuprolide and Oxytocin Peptide Octreotide Strong export presence manufacturer accounting for ~75% of revenues Hold CEP for Leader in solution Oxytocin, Key clients phase Oxytocin … Desmopressin, Strong foothold in include Pfizer, leading to large Somatostatin, Apotex, Merck quantities and pharmaceutical and vet Leuprolide, and Novartis cost effective industries. Looking at Calcitonin and processes Buserelin penetrating cosmetics and innovator companies “Global Supplier of Quality Peptide Products” Privileged & Confidential 8 Products under patents Active Brand Application Patented Stage of Development Eptifibatide Intergrilin Used in management of Expired in 2015 Completed in Q3 (Millenium) Percutaneous Coronary 2015 Intervention Glatiramer Copaxone (Teva) Used to treat Multiple Expired in May Completed in Q2 Sclerosis 2015 2015 Atosiban Tractocile (Ferring) Used as Tocolytic to halt Expired in 2008 Completed in Q2 premature labour 2015 Exenatide Byetta (Amylin) Used in treatment of Type 2 Yes To be completed Diabetes Patent to expire in Q2 2016 in Dec 2016 Glucagon Glucagen (Novo Used in treatment of Expired in July To be completed Nordisk) Hyperglycemia 2014 in Q2 2016 Degarelix Firmagon (Ferring) Used in treatment of Prostate Yes Completed in Q4 Cancer Patent to expire 2015 in 2020 Privileged & Confidential 9 Infrastructure Overview Privileged & Confidential 10 Infrastructure overview Site Distance Activity Owned / rented Commenced Built up area Head from in count (sq. ft.) airport Turbhe, Navi 30 km Manufacturing all products Owned 2007 50,000 154 Mumbai including Oxytocin for (Additional regulated markets 25,000 Sq. ft. can be constructed) Thane 30 km R&D centre and Owned 1986 10,000 30 manufacturing of Oxytocin for non regulated markets Girona, N/A R&D center Rented 2012 2,000 6 Spain Mahalaxmi, 17 km Corporate office Owned 2003 2,700 16 Mumbai Privileged & Confidential 11 Strong in-house QC capabilities Strong 50+ member team Quality Control – Salient Features In house microbiology lab for water and environment Ability to perform most analyses monitoring in addition to in house, external labs that are product testing used are audited and approved Privileged & Confidential 12 Quality Assurance team 45+ successful Successful customer audits system of self conducted audits Well defined internal as well as external Regulatory and Strong training documentation skills control & program help customers investigation Responsible deftly file their of root cause to release ANDAs of deviation Team batches independent and OOS of QC & production Teams are robust enough to sustain growth in turnover Privileged & Confidential 13 Business Development Initiatives Privileged & Confidential 14 Sales Reach – Direct and Distributors Focus geographies are USA, Canada, Europe, Asian Subcontinent and Latin America which contribute to majority of exports Privileged & Confidential 15 End of Presentation Privileged & Confidential 16 .
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