Alembic Pharmaceuticals Limited Investor Presentation December 2013 BSE: Symbol: ALEMPHARM Code: 533573 NSE: Symbol: APLLTD ISIN: INE901L01018 www.alembic-india.com
Safe Harbour Statement Materials and information provided during this presentation may contain ‘forward-looking statements’. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Risks and uncertainties include general industry and market conditions and general domestic and international economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited, to technological advances and patents attained by competitors, challenges inherent in new product development including completion of clinical trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare reforms; trend towards managed care and healthcare cost containment and governmental laws and regulations affecting domestic and foreign operations. Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited, to inability to build production capacity to meet demand, unavailability of raw materials and failure to gain market acceptance.
Agenda The Alembic Journey Insight - Alembic Overview Insight - Strategic Advantage Growth Drivers Business Strategy and Approach Financials Corporate Social Responsibility
Agenda The Alembic Journey Insight - Alembic Overview Insight - Strategic Advantage Growth Drivers Business Strategy and Approach Financials Corporate Social Responsibility
The Alembic Journey 2003 State-of-the-art 2001 F ormulations facility for Starts R egulatory 1972 manufacturing Markets of "Althrocin"- a C ephalosporin C 1971 brand of E rythromycin E rythromycin launched 1961 manufactured for the first Lal Bahadur time in India 1940 Shastri, the then Started P rime minister 1907 manufacturing inaugurates the cough syrup, P enicillin plant Started vitamins, tonics manufacturing and sculpture tinctures and drugs alcohol at V adodara
The Alembic Journey 2013 - P ara IV filed 2011 - C umulatively 60 ANDAs filed, - ANVISA (31 ANDA/NDA 2010 approvals approved) - Aggressive and 64 DMF s - Azithral sales ANDAs and 2009 R each INR DMF s filing 1000 million Addressed mark 2007 chronic therapies - Demerger AL -APL through Acquisition of multiple 2006 Non-O ncology marketing Business of divisions US F DA M/s Dabur 2004 approvals for Pharma Ltd. API and State-of-the-art F ormulation R esearch Plants C entre established in V adodara
Agenda The Alembic Journey Insight - Alembic Overview Insight - Strategic Advantage Growth Drivers Business Strategy and Approach Financials Corporate Social Responsibility
Insight - Alembic Overview Branded Formulations Revenue of INR 8860 million Ranked 21st in the Ranked 15th in Well equipped Indian Formulations Doctors Prescription Formulations Plant in the India market for market with a market Universe** located at Baddi, the financial year 2012-13 share of 1.76%* Himachal Pradesh Robust product basket Strong presence in Thrust on Cardiology, Dermatology division launched with export sales of anti-infective, Gynecology, GI, INR 440 million in the financial pain management, Diabetes, Orthopedics, year 2012-13 in International cough & cold Rheumatology and Branded Formulations Ophthalmology segments *Source: ORG November, 2013 **Source: ORG Prescription Audit
Insight - Alembic Overview International Division Business size of Sales in Regulatory 1 US FDA World-class R&D and F&D INR 5960 million in the Generics Market of INR 2450 approved Formulations facility financial year 2012-13 million in the financial year Plant 2012-13 Alliances with leading Robust product basket 3 US FDA Approved generic players in USA, with 31 ANDA/NDA approvals approved Bio Equivalence Canada, Europe, Australia, (60 filings) and 64 DMFs. API Plants Centre Brazil and South Africa and Para IV filing
Business Portfolio R&D BRANDED Alliances API Quality FORMULATIONS Business Synergies INTERNATIONAL Manufacturing GENERICS Efficiency
Agenda The Alembic Journey Insight - Alembic Overview Insight - Strategic Advantage Growth Drivers Business Strategy and Approach Financials Corporate Social Responsibility
Strategic Advantage Alembic Research Centre is Well-developed the first in India to be Infrastructure facility - Information Security Certified 4 US FDA approved plants High-end quality / Highly talented pool of RA structure 300 Research Scientists Manufacturing excellence R&D / F&D / Captive with optimal cost benefits Bio-equivalence facility Therapy focused marketing Therapy focused marketing Strong partnership Long term relationship with through 12 marketing arms through over 3,900 field force and alliance on PAN India basis covering over 1 lac doctors in Generic space API customers
Manufacturing Infrastructure Formulations- G enerics A PI B randed Formulations (R egulatory Markets) USFDA, MCC, MHRA, Formulations plant at USFDA, EDQM, TGA, WHO ANVISA, TPD approved Baddi, Himachal Pradesh approved API facility at formulations facility at Panelav Panelav (2 units) and at Karkhadi (1 unit) Current annual production capacity of plus 3 billion tablets/capsules
Manufacturing Infrastructure Certifications
Alembic Research Centre State-of-the-art Analytical & IPR infrastructure R&D F A C ILITY F&D C A P A B ILITIE S B IO E Q UIVA LE NC E C E NTRE R&D Centre has been Expertise in Drug Deliveries State-of-the-art 90-bedded new recognized by DSIR, and Niche Formulations Bio Centre Govt. of India Well-defined Processes 100 Bio Pilot Studies High-end R&D Equipment - and Quality Systems NMR XRD, TGA, DSC, LCMS Capabilities in Solid Oral, 50 Pivotal Studies World-class Infrastructure Liquid Oral Products
Research Capabilities FORMULATIONS API 60 64 60 ANDA Filing ANDAs filed DMFs filed ANDAs filed DMFs filed with DMFs Filing DMFs Filing 31 ANDA / NDA 57 60 approvals 54 45 44 37 32 26 25 18 18 11 18 13 12 11 13 7 7 7 9 6 8 6 Up to 2008-09 2009-10 2010-11 2011-12 2012-13 Up to 2008-09 2009-10 2010-11 2011-12 2012-13 2007-08 2007-08
Effective Marketing PAN India Marketing and Distribution Network ZENOVI OSTEOFIT Orthopedics Gynecology SPECIA Cardiology Diabetes SUMMIT Urology EYECARE INTENSA ENTERON Cardiology Ophthalmology Critical Care Gastroenterology Diabetes MAXIS ALCARE OTC & Rural General Focused SPECIALITY PHARMA MEGACARE MARKETING General Acute General Acute DIVISION Division Division Future Segment: Respiratory therapies New Segment entered: Dermatology
Effective Marketing PAN India Marketing and Distribution Network VETERINARY GENERICS & NSA OTHER PRODUCT PORTFOLIO
Major Product Portfolio Top Therapatic Ranking * Other Therapatic Products Area Products Area Rekool Gastroenterology Azithral Anti Infective 34 Zeet/Bro-Zeet Cough & Cold Althrocin 60 Anti Infective Tellzy Cardiology Wikoryl Cough & Cold 150 Gestofit Gynecology Sharkoferrol T onic Roxid Anti Infective 166 Tetan Cardiology 283 Gestofit Gynecology Livfit Hepaprotectives Zofix Anti Infective Ulgel Antacid and Anti Flatulant Glisen Anti Diabetic Ovygin Gynecology * Source: ORG November, 2013
Agenda The Alembic Journey Insight - Alembic Overview Insight - Strategic Advantage Growth Drivers Business Strategy and Approach Financials Corporate Social Responsibility
Growth Drivers Branded Formulation Business International Generic Business CAGR CAGR INR million INR million 37 % 13% 55% 9 % 8860 2450 2550 7830 6930 1020 2010-11 2011-12 2012-13 2010-11 2011-12 2012-13
Growth Drivers Branded Formulations Enhanced focus on existing branded business Through effective pan-India distribution Expected network and therapy based marketing annual growth and by pushing ahead acute and chronic segments like anti-infectives and cough 15-18% & cold medications Launch 20-25 new products Launch of new products to boost sales momentum and brand build up Enter into new therapeutic segment Future indentified therapy – Respiratory will further expand the company’s spread
Growth Drivers International Generics Superior cost efficiency Position Alembic as a cost efficient dependable quality manufacturer Expanded annual production capacity Annual production to increase from 2.6 billion tablets/capsules to 5 billion tablets/capsules in 2013-14 ANDA filings and approvals for off-patent drugs Over the next five years, products that currently generate more than USD 142 billion In sales are expected to go off-patent. Alembic can tap these opportunities by launching new generic products at appropriate times.
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