Committed to Perform
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Spine 8.5mm GLENMARK PHARMACEUTICALS LIMITED GLENMARK PHARMACEUTICALS Committed to perform Committed to perform ANNUAL REPORT 2015-16 REPORT ANNUAL www.glenmarkpharma.com ([email protected]) concept, content and design at ANNUAL REPORT 2015-16 JSNR_Glenmark AR 2016_Cover.indd 1 7/15/2016 3:31:04 PM Spine 8.5mm CONTENTS A TRIBUTE TO THE FOUNDER Glenmark at a Glance 02 Our Global Assets 04 Our Strategic Priorities 06 Chairman’s Message 08 Board of Directors 12 Committed to Perform 01 - Through Innovation 14 Corporate Overview - Through Global Expertise 20 - Through a Spirit of Excellence 24 Corporate Responsibility 26 Our People 30 Key Financials 32 Corporate Information 33 Management Discussion & Analysis 34 Prole of Directors 52 Board’s Report and Relevant Annexures 53 02 Report on Corporate Governance 90 Statutory Reports Standalone Auditor’s Report 105 Standalone Balance Sheet 110 Standalone Statement of Prot & Loss 111 Standalone Cash Flow Statement 112 Standalone Notes to Financial Statements 114 Founder: Late Mr. Gracias Saldanha Consolidated Auditor’s Report (IFRS) 148 Consolidated Statement of Financial Position (IFRS) 150 Consolidated Statement of Comprehensive Income (IFRS) 151 Consolidated Statement of Changes in Shareholder’s Equity 153 Achievement, Respect and Knowledge are the 03 (IFRS) Financial Statements Consolidated Statement of Cash Flow (IFRS) 154 values on which he built Glenmark. The seed of Notes to Consolidated Financial Statements (IFRS) 155 Consolidated Auditor’s Report (IGAAP) 195 our phenomenal growth story lies in the values Consolidated Balance Sheet (IGAAP) 198 instilled by our founder. And, it is these values Consolidated Statement of Prot & Loss (IGAAP) 199 Consolidated Cash Flow Statement (IGAAP) 200 which continue to guide the Company achieve Consolidated Notes to Financial Statements (IGAAP) 202 greater heights going ahead. Log on to www.glenmarkpharma.com to view this report available online JSNR_Glenmark AR 2016_Cover.indd 2 7/15/2016 3:31:12 PM At Glenmark, our continuous endeavour has been to perform consistently. The world is grappling with uncertainty and volatility. The old order is being challenged. Disruption is commonplace. Crude and commodities have been in a free fall. The geopolitical situation is stressful. Amid all of this, the Indian economy stands tall as a symbol of stability and fortitude. However, has always been one of our key strengths, and we are now in the nal phase of operationalising our formulations plant the global headwinds have not in Monroe, North Carolina. We in-licensed generic Seretide spared many companies that are Accuhaler in Europe, a signicant step towards building a linked to world trade. Our belief strong respiratory franchise in Europe. helped us act with resilience and Our out-licensing deals have helped us build a reputation of an innovation-driven organisation. We are committed to deliver encouraging outcomes, enriching lives by nding cures for unmet medical needs. We despite challenging industry have regularly made investments in R&D and have a strong in-house pipeline of seven novel molecules, both NCEs and scenario. NBEs, in pre-clinical/ clinical development. We now have two clinical candidates targeting oncology indications based on We registered good revenue growth during the year, our proprietary best-in-class BEAT® platform. primarily driven by our strong performance in India and the US. We gained signicant market share with several new With our robust pipeline of products across all markets, product launches as we continued to focus on the areas a strong innovative engine, a well spread and diversied of dermatology, respiratory, cardiovascular and diabetes. manufacturing set-up, a truly global team and robust systems This was an important year as our US business received and process along with our dedication to perform, we are the highest number of approvals till date. Strategic location certain that we will attain new heights in the years to come. Glenmark Pharmaceuticals Limited Annual Report 2015-16 RESEARCH-DRIVEN, GLOBAL AND INTEGRATED We at Glenmark, are relentlessly striving to make the lives of patients better across the globe since 1977. We are a leading, research-driven, integrated, global pharmaceutical organisation. Listed with Indian stock exchanges in 2000, Glenmark has current market capitalisation of USD 3.6 billion*. In the pursuit of enriching lives, Glenmark has evolved into a global organisation and a leading player in the discovery of molecules within a short period of time. Glenmark is actively engaged in the development of New Chemical Entities (NCEs) and New Biological Entities (NBEs), and has 7 novel molecules, 2 NCEs and 5 NBEs, in various stages of pre-clinical and clinical development. Vision TO EMERGE AS A LEADING INTEGRATED RESEARCH-LED GLOBAL Ranks among the top 80 11 nished dosage plants in four Established research capabilities in both novel Commercial presence companies in the world1 countries small molecules and biologics across ve continents Ranks 8th among 5 API plants in India for captive and 7 innovative molecules in advanced clinical and More than 70% companies in Asia2 commercial requirements pre-clinical stages of development of revenue from international markets Ranks 10th among 1 biologics manufacturing site in companies based out of Switzerland emerging markets3 Fastest growing among top 20 pharmaceutical companies in India4 PHARMACEUTICAL COMPANY Glenmark’s business has been GLENMARK primarily structured into Branded and Generic Formulations, Active Pharmaceutical Ingredients (APIs), AT A GLANCE and Drug Discovery & Development. Notes: • 1: SCRIP Rankings 2016 | 2: excludes Japan | 3: includes countries like Brazil, Russia, India, China and South Africa | 4: In terms of retail formulation sales (Source: IMS) • *Exchange rate: USD1 = ` 66 (Market data based on closing pricing on NSE as on 31 May, 2016) 2 CORPORATE OVERVIEW STATUTORY REPORTS FINANCIAL STATEMENTS Formulations API Manufacturing Development & & Marketing NME & Specialty Marketing Branded Generics Captive consumption Small molecules and Formulations Formulations and external sales complex biologics Brand building in Substitution selected therapies model Key geographies Key facilities North America, Europe, Japan, Switzerland India, Latin America Dedicated research and development Key geographies Key geographies centre for biologics (NBEs) India, Russia & CIS, Latin America, North America India Asia, Africa, CEE Western Europe Discovery and development of NCEs and Formulations, and API R&D Revenue generating segments Investing for the future our endeavour to offer high quality and DRUG DISCOVERY to-strength and is focused in the differentiated generic products. With an We believe innovation is the only way emerging markets of India, Russia expected market size of USD 2.4 billion it to build a truly global organisation that and CIS, Africa, Asia, Latam etc. The poses signicant growth opportunity for delivers outstanding results. In line with formulations business focuses on the Company. this belief, Glenmark’s ground-breaking therapeutic areas viz. dermatology, anti- drug discovery efforts are focused in infective, respiratory, cardiac, diabetes, API the therapeutic areas of Inammation, gynaecology, CNS, and oncology. India Glenmark’s API division partners with Pain and Oncology. Glenmark has a is the largest market in terms of revenue leading global generic companies, pipeline of seven rst-in-class molecules, for the organisation. by supporting partnerships through both NCEs and NBEs, in clinical and advanced process chemistry skills and pre-clinical development. Glenmark GENERIC FORMULATIONS innovative intellectual property. has made its mark in this area by out- Our products are primarily marketed We supply APIs for captive consumption licensing its own molecules in various in US and Western Europe. Our US and to leading generics companies stages of clinical development to formulations contributed 32% of net across US, Europe, Japan, India and large global multinationals. Glenmark revenue and Europe formulations other markets. Glenmark is a market has successfully out-licensed seven contributed 9% of net revenue in FY16. leader for many API products in molecules to ve companies and have We are one of the largest dermatology semi-regulated markets and has also received a total of USD 217 million players in the US Generics market established a leadership position with in up-front and milestone payments, and have become the fastest growing its rst-to-le offerings in regulated cumulatively. We are the only company generic company in Germany. Our markets. Some of our products from emerging markets to execute US product portfolio consists of more that enjoy leadership positions are multiple deals on novel molecules. than 110 generic products authorised Amiodarone, Lercanidipine, Adapalene for distribution. In US, we have the and Perindopril. Our API business BRANDED FORMULATIONS largest number of products authorised contributed 9% to the net revenue in In pursuit of our mission of enriching for distribution among the generic FY16. Our two API plants in Ankleshwar lives, Glenmark’s Branded Formulations manufacturers. We aim to launch Sole and Dahej successfully completed US business has grown from strength- FTF – g-Zetia in December 2016, in FDA inspections in FY16. We enjoy market leadership in focused #2 #6 #8 therapy areas in Indian in Derma in Respiratory in Cardiac Pharmaceutical Market: 3 Glenmark Pharmaceuticals Limited Annual