ANNUAL REPORT 2019-20
BRINGING HOPE
6
COMPANY INFORMATION
BOARD OF DIRECTORS SOLICITORS Mr. umayun Dhanrajgir Parinam Law Associates, Chairman Ad ocates & Solicitors Mr. Shree ant Bapat Independent Director BANKERS Mr. Berjis Desai Axis Ban Limited Independent Director Ban of Baroda Mr. Samonnoi Banerjee Director (Nominee of BC Investment IV Ltd) Ban of Maharashtra Mr. Palamadai Jaya umar Export Import Ban of India Additional Director (w.e.f. July 22, 2020) Siemens Finance Mr. Satish Mehta Aditya Birla Finance Limited Managing Director & CEO Tata Capital Financial Ser ices Limited Mr. Sunil Mehta Whole-time Director REGISTERED OFFICE Dr. Mu und Gurjar Whole-time Director Emcure ouse, T-184, M.I.D.C., Bhosari, Pune 411 026. Mrs. Namita Thapar Whole-time Director & CFO Tel: 020-30610000 Fax: 020-30610111
COMPANY SECRETARY Mail us at: Mr. Sanjay Kumar Chowdhary (upto Nov 01, 2019) corporate emcure.co.in Mr. Jayant Pra ash (w.e.f. Dec 07, 2019) Website : https://emcure.com STATUTORY AUDITORS M/s BSR & Co. LLP, Chartered Accountants CORPORATE OFFICE INTERNAL AUDITORS Plot P-2, I T - B T Par , M.I.D.C, M/s Price Waterhouse, Chartered Accountants injawadi, Pune 411 057 Tel: 020-39821300 COST AUDITORS Fax: 020-39821400 M/s B. M. Sharma & Co., Cost Accountants
SECRETARIAL AUDITORS M/s SVD & Associates Practicing Company Secretary
1 OUR VISION
“Emerge as a technology driven global player offering high quality and cost effective healthcare”
OUR CORE VALUES
Quality & Team Work Value Integrity Innovation Patient Focus & Respect Driven
2 CONTENTS
COMPANY OVERVIEW Emcure at a Glance 01
Board of Directors 02
Senior Management Team 03
Consolidated Financial Highlights 04
CEO Speaks 05
Research and Development 07
Manufacturing 11
Human Resources 14
Management Discussion and Analysis 19
Risks 29
Corporate Social Responsibility 32
Board's Report 38
Corporate Governance Report 61
FINANCIAL STATEMENTS Independent Auditor's Report 66
Standalone Financial Statements 72
Independent Auditor's Report-Consolidated 134
Consolidated Financial Statements 137
3 EMCURE AT A GLANCE
EFFECTIVE MEDICINE FOR CURE Emcure’s name embodies company’s purpose and core belief – to make effective medicine accessible to patients, enabling them to lead healthier lives. Since its inception in 1981, Emcure has established a vertically integrated infrastructure for developing and manufacturing a wide range of medicines and marketing them in India and abroad. Emcure is, today, ranked amongst the leading pharmaceutical players in India.
SUCCESS THROUGH INNOVATION Innovation, one of Emcure’s core values, is ingrained in our culture and reflected in all our operations. Our Business Strategy, driven by the entrepreneurial spirit, has led us to adopt different business models across geographies. Emcure’s operations are focused towards building a robust product portfolio including differentiated platforms such as Novel Drug Delivery Systems, Biosimiliars, Chiral chemistry, Injectables etc. Emcure aims at creating strong brand equity by promoting top class products. We are oriented towards serving our customers, consumers and community globally and thus we have the highest regard for quality. In a fast changing global pharmaceutical industry, it has been our constant endeavour to equip ourselves with required resources that would aid our growth.
1 BOARD OF DIRECTORS
NON-EXECUTIVE DIRECTORS
Mr. Humayun Mr. Shreekant Mr. Berjis Dhanrajgir Bapat Desai
Mr. Samonnoi Mr. Palamadai Banerjee Jayakumar
EXECUTIVE DIRECTORS
Mr. Satish Dr. Mukund Mr. Sunil Mrs. Namita Mehta Gurjar Mehta Thapar
ANNUAL REPORT 2019-20 : BOARD OF DIRECTIOS 2 SENIOR MANAGEMENT TEAM
Mr. Satish Mehta Mrs. Namita Thapar Mr. Samit Mehta Mr. Vikas Thapar Managing Director, Whole-time Director, President, President, Group Chief Executive Officer Chief Financial Officer Research & Development Corporate Development & Strategy
Mr. Sanjay Mehta Mr. Sunil Mehta Dr. Mukund Gurjar President - Commercial Whole-time Director Whole-time Director, Chief Scientific Officer
Mr. Pradeep Vaishnav Mr. William Marth Dr. Sanjay Singh President, President and Chief Executive Officer, Whole-time Director, North America & Europe Chief Executive Officer Global Human Resources Gennova Biopharmaceuticals Ltd.
Mr. Prakash Guha Dr. Steven Hagen Mr. Frank Katona Managing Director, Executive Vice President, Global Head, Zuventus Healthcare Ltd. Quality Compliance Operations
3 ANNUAL REPORT 2019-20 : SENIOR MANAGEMENT TEAM CONSOLIDATED FINANCIAL HIGHLIGHTS
Consolidated Re enues INR Mn. EBITDA INR Mn.
52000 14000 50486 11644 50000 12000 48000 47172 10000 8729 8439 8131 7862 46000 8000 44169 44000 6000 42507 42364 42000 4000
40000 2000
38000 0 FY16 FY17 FY18 FY19 FY20 FY 16 FY 17 FY 18 FY 19 FY 20
Geographywise Re enues INR Mn. Net Worth INR Mn.
50000 5713 30000 27831 5481 26021 2404 24550 40000 3015 3787 25000 22511 20000 19445 30000 23689 21386 20472 21212 21854 15000 20000 10000 18076 18106 18105 20478 22918 10000 5000 0 0 FY16 FY17 FY18 FY19 FY20 FY16 FY17 FY18 FY19 FY20
Domestic Regulated R
Profit After Tax (INR Mn.)3 Gross Bloc INR Mn.
7000 40000 6365 33805 6000 35000 33088 30000 28102 5000 25000 24141 4000 3691 20000 18249 3000 2586 15000 2223 2041 2000 10000 1000 5000 0 0 FY 16 FY 17 FY 18 FY 19 FY 20 FY16 FY17 FY18 FY19 FY20
Note 1: Figures mentioned above for FY16, FY17, FY 18, FY19 and Fy20 are as per Ind AS. Note 2: Regulated markets represent Emcure’s presence in US , Canada and Europe markets. Rest of the World represents Emcure’s presence in countries in Africa, Latin America, the Middle East, and South East Asia and in Australia. Note 3: PAT represents PAT before Other Comprehensive Income and excludes the impact of exceptional items i.e. legal settlement fees, USFDA remediation consultancy fees and legal fees on account of DOJ investigation in FY16, FY17, FY18, FY19 and FY20 and sale of property in UK, sale of investment in Konsina in FY18, reversal of SAR provision in FY19 and write-o of insurance claim receivable in FY20. ANNUAL REPORT 2019-20 : CONSOLIDATED FINANCIAL HIGHLIGHTS 4 CEO SPEAKS Our mRNA vaccine Dear Shareholders of Emcure, for COVID-19 I hope you and your loved ones are staying safe and well in these unprecedented times. got approved by Never before has humanity faced such a Department of challenge with far reaching consequences on Biotechnology and life and livelihoods ! we plan to start Being one of the major healthcare companies of our country, we have taken our civic human trials in responsibility very seriously and tried our best October. to address the ongoing challenges. We have distributed over 30 lakh HCQ tablets to all health care professionals, we have distributed PPE kits and masks and also helped with the migrant labourers in our city. Our proudest moment was when our mRNA vaccine got approved by Department of Biotechnology and we plan to start human trials in October. Rest assured we will do our very best for not just our country but globally as well.
I would like to give you an overview of our operations for 19-20. The impact of pandemic was not significant in 19-20 financials and therefore we have shown strong operational performance.
In terms of overall performance, revenue for the year was Rs.5,048 cr, growing at 7% over previous year, EBITDA was Rs. 786 cr (15.6% of sales) and PAT was Rs. 204 cr. We pride ourselves on having a diversified portfolio across key therapeutic areas and geographies and this diversification strategy has helped us and will continue to drive growth year after year.
5 CEO SPEAKS The domestic business posted solid growth have been unwavering in our pursuit with revenues of Rs. 2,292 cr, up 12% from of developing specialty products and previous year, inspite of slower sales in identifying opportunities in the domestic March due to the impact of country wide and global markets. We are proud to lockdown. Emcure continues to strengthen introduce Dynulta (sucro ferric) first time its focus in 17 plus therapeutic areas under in India at 70% cheaper than the innovator. the leadership of Mr. Pratin Vete, Zuventus Our commitment to provide access and continues to grow year over year under the affordability to citizens of India continues! leadership of Mr. Prakash Guha. We remain The HR function under the leadership of highly optimistic about this business line. Mr. Pradeep Vaishnav continues to focus We continue to focus on data analytics on safety and well-being of our employees. and sales force effectiveness to bring in A special mention must be made of HR continued cost and productivity gains year Director Mr Rajesh Nair who ensured over year. uninterrupted production even during While Europe grew by 7.2% to Rs. 607 cr, lock down while at the same time taking Canada posted an impressive 61% growth herculean efforts to ensure safety of our to Rs. 493 cr. The US business continues workers. The production and HR team must to see pricing pressures, new entrants be applauded for this service to the nation and intense competition among existing in the face of paranoia and other unforeseen manufacturers in the generics market constraints. which has led to a decline in US sales. US We are all aware that FY21 will be a has shown degrowth of 13% and ended the challenging year but our team is working year at a revenue of Rs 1,074 cr. extremely hard to ensure that we stay agile, The RoW markets gave an outstanding vigilant so we may adapt and exit the year performance growing at 4% to post with responsible growth. revenues of Rs. 571cr. The growth is largely This is a time to serve our country and we attributable to ARV business. In the Non- are proud to be in healthcare that truly gives ARV segment, LATAM markets showed us an opportunity to make a difference and robust growth, followed by Russia and CIS make an impact ! market. We thank you for your continued support A key component of your Company’s growth over all these years and for helping us strategy has been to act on differentiated deliver value. Thank you for placing your new product opportunities and make the trust and faith in us. best of them. Our efforts in R&D driven by Dr. Mukund Gurjar and Mr. Samit Mehta
ANNUAL REPORT 2019-20 : CEO SPEAKS 6 RESEARCH AND DEVELOPMENT
• Emcure’s R&D efforts are dedicated towards five towards Formulations research and two development of differentiated pharmaceutical towards Biotechnology research. formulations, sophisticated characterization of complex molecules and product and process • In the current year, Emcure invested 4% of improvements to achieve better quality and total sales in R&D activities, in line with our productivity. The company has been growing commitment to focus on R&D and build a strong its in-house Research and Development and robust product pipeline. We are undertaking infrastructure and capability to develop a strong more complex products in our R&D portfolio, that market position through differentiated products. coupled with the increase in regulatory guidelines and requirements has led to an increase in • The Research and Development team at Emcure investment. comprises of more than 450 highly qualified scientists, including 10 post doctorates, 40 PhD’s • Emcure’s in-house regulatory affairs unit has and 352 postgraduates. Emcure’s R&D activities significant expertise in filing product dossiers are spread across its 9 dedicated facilities, with regulators in the United States, the located in Pune (Bhosari, Hinjawadi, Pimpri), European Union, WHO-PQ and other jurisdictions Ahmedabad and New Jersey. Of the 9 R&D and is capable of submitting DMFs, ANDAs and centers, two are focused towards API research, Marketing Authorizations in common technical document (“CTD”) format.
7 ANNUAL REPORT 2019-20 : RESEARCH AND DEVELOPMENT RESEARCH AND DEVELOPMENT
Patents and ANDA Filing updates: this area involves both solid phase and solution phase peptide synthesis chemistry. The most • Emcure has made 2 ANDA product applications critical segment of peptide research is the high (including 1 injectable and 1 solid oral products) end separation of peptides in order to ensure in FY20, taking the total number of ANDA filing their structure, purity and potency. Emcure has st as on March 31 , 2020 to 301 (including 28 Para- perfected the science of separation of peptides IV’s). Total of 5 First to File products have been at manufacturing scale by implementing state- filed till date. of art technology along with the development of high-end skill set. The peptide chemistry has • Of this 184 products are approved and been demonstrated in Atosiban Acetate. It is 06 products are tentatively approved as on used intravenously to halt premature labor. March 31st 2020. • These products, • 4 US DMF applications were made in FY20, taking Complex Generic API’s: owing to their complex structural parameters, the total number of DMF filings to 115 (96 DMFs require unique process maneuvering. Also, the Active. Apart from this Emcure has filed 6 EU characterization and bioequivalence studies, as DMFs, 7 DMFs in Canada & 1 DMF in Australia per the USFDA guidelines, require sophisticated (totally 18). spectroscopic and biochemical analysis. All these • As on 31st March 2020, 402 patent applications requirements are built in- house to ensure safety have been made, including 43 PCT applications. and efficacy of complex generic APIs. We have Total of 153 patents have been granted. already developed and commercialized some of these products, such as iron preparations and API Research low molecular weight heparin, in the Domestic Market. A novel process for Treprostinil containing API research at Emcure focuses on synthesizing 5 chiral centers has been commercialized. The molecules that match the innovator product in novelty resides in asymmetric Posankhand the most robust and cost effective manner. With reaction. a commitment to deliver high quality and cost efficient healthcare to our customers, the API R&D • Onco products: Emcure had always been team strives to develop efficient and robust process a market leader in onco-products for both for generic compounds at a fraction of the available domestic market as well as regulated market. costs. The five pillars that form the base for API Keeping that commitment to the customers we research in Emcure are: have been able to develop extremely complex API’s entailing multi-step transformation and Emcure is recognized as • Chiral Chemistry: concomitant generation of chiral centers. the pioneer in chiral chemistry. Emcure has The onco product Eribulin involving 45 steps effectively developed and marketed 11 chiral synthesis has been successfully commercial in molecules which have demonstrated greater Indian market. Incidentally ‘EMBREMMA’ is 1st effectiveness, safety and require lesser dosage generic developed by Emcure in the world. than their non-chiral counterparts For e.g. S(-) Amlodipine Besilate, S (-)Metoprolol Succinate, • Photo-Chemistry: - Emcure has developed Dexrabeprazole Sodium, S(-) Etodolac, expertise to deliver complex generics via Dexketoprofen Trometamol. phytochemical transformations. Delivery of these products needs customized reactor Emcure has • Polymer Based Chemistry: design which with intricate photochemical commercialized in India API’s like Sevelamer reactor design. These products can only be Hydrochloride and Sevelamer Carbonate that are delivered with mellifluous integration of state- based on Polymer based chemistry. of-art engineering and complex chemistry which • Peptide Chemistry: Our focus of research in Emcure has mastered.
ANNUAL REPORT 2019-20 : RESEARCH AND DEVELOPMENT 8 RESEARCH AND DEVELOPMENT
Formulations Research • Emcure’s formulation research is centered • Conventional Parental preparation including towards developing multiple dosage forms and sterile solutions and suspension; oncology novel drug delivery systems, capable of greater and non-oncology products; efficacy and better patient compliance. • Lyophilized oncology and non-oncology • Ongoing product research is focused on dosage products; forms including: • Novel injectable products (Nano-suspension • Conventional solid dosage forms such and nano-emulsion injectables, liposomal as immediate release tablets/capsules, drug delivery system and Long acting effervescent tablets, soft gelatin capsules, (Microspheres) injection); orally disintegrating tablets/flash tablets; • Oral liquids (solutions, suspensions); • Modified release dosage forms like delayed release tablets/capsules, MUPS, tablet in • Transdermal Drug delivery system (Adhesive tablet, Pulsatile drug delivery system, osmotic matrix, Hydrogels, Reservoir Drug delivery drug delivery system, Extended/Controlled system); Release dosage forms, Time release dosage • Respiratory products (inhalers). forms;
Research and de elopment expense as of sales
2500 6.0
5.0 2000 5.2 5.0 4.9 4.5 4.0 1500 3.8 3.0 1000 2.0 500 1,978 2,092 2,200 2,367 1,922 1.0 - 0.0 FY16 FY17 FY18 FY19 FY20
Series 1 Series 2
9 ANNUAL REPORT 2019-20 : RESEARCH AND DEVELOPMENT
Chart Title DMF filings 350 300 140 250 117 120 100 200 133 115 119 108 114 80 101 150 107 185 97 103 60 100 105 40 84 50 74 79 20 0 0 FY16 FY17 FY18 FY19 FY20 FY16 FY17 FY18 FY19 FY20 RESEARCH AND DEVELOPMENT
Biotechnology Research Biosimilars: • Our research on biosimilars use all three expression platforms, mammalian, yeast and bacterial, and perfusion-based bioreactor systems. We focus on developing recombinant therapeutic innovator products in three main therapy areas - Cardiovascular, Nephrology and Oncology. Some of our biosimilar manufacturing processes are patented in India.
Vaccines and mAbs: • We have various vaccines and mAbs programs in the development phase that are funded by public- private partnerships. Funding for our vaccines and mAbs research has allowed us to collaborate with leading medical institutions on several blood stage and transmission blocking malaria vaccine candidates. These partnerships allow us to build our analytical capabilities as we build our in house mAbs program using perfusion based production system.
ANNUAL REPORT 2019-20 : RESEARCH AND DEVELOPMENT 10 MANUFACTURING
• Emcure’s manufacturing operations are spread management, manufacturing efficiency and new across 11 manufacturing facilities, 10 in India product time to market. (Pune, Sanand, Kurkumbh, Sikkim, Bangalore and Jammu) and 1 in New Jersey, United States. • Your company continues to invest in improvement of manufacturing facilities to keep them up to • Emcure took a number of meaningful steps expectations of various Regulators (including towards developing supply chain processes and USFDA where we are undergoing remediation systems to support high levels of growth and the efforts) and for capacity expansion requirements. increased complexities associated with becoming an exceptional competitor in the global markets. • The Hinjewadi Oral Solid Dose facility completed a Experienced industry professionals responsible robust inspection preparation program designed for Global Supply Chain and Procurement were to assure the facility is ‘inspection ready’ on any added to the management team. With this given day and is very well placed for the next new functional leadership, a disciplined Sales USFDA audit. and Operations Planning process has been • Progress continued at our Sanand facility with implemented and is expected to improve key the installation and commissioning of a new performance indicators across the enterprise higher speed filling line for terminally sterilized including customer service, inventory
11 ANNUAL REPORT 2019-20 : MANUFACTURING MANUFACTURING
products and successful approval for use by o Oncology and Injectables Plants in USFDA. In addition, successful completion of our Hinjewadi were approved by Croatian, aseptic liquid /lyophilized filling line has allowed Korean, Australian and Canadian regulatory us to initiate a robust plan of registration batches authorities. for these products as well. o Hinjewadi Oral solid dosages plant was • The Oncology area embarked upon a very approved by Croatian, Australian and focused output increase/efficiency improvement Canadian regulatory authorities. program that when complete will significantly o Sanand (Injectables plant) was approved by add to our capacity and favorably contribute the Croatian regulatory authorities. to our manufacturing cost targets and supply o Also, during the year, US FDA approved our reliability. Kurkumbh (API) facility.
• The Hinjewadi facility, which is our major campus for supplying products to the regulated markets, Manufacturing capabilities: was placed under import alert by US FDA in July 2015. In response to the event, the company has 1. Solid Orals: implemented series of changes that have systemic • Our solid oral manufacturing capability is spread impact including hiring new mid and senior level across different forms including conventional managers, investing heavily in employee training immediate release dosage forms, modified and automation of manufacturing activities. release dosage forms which include tablet and • Key organizational changes within our capsules, soft-shelled capsules, dissolvable and manufacturing sites and functional areas were chewable tablets and hard and soft-shelled implemented addressing targeted improvement capsules, multi-particulate dosage forms, areas. Among these were the formation of osmotic Drug delivery systems. designated ‘Investigation management’ teams • We have taken various steps to enhance and within all sites to better identify, evaluate and improve our production capabilities: - address manufacturing batch processing failures. In addition, the site leadership organizations o We have enhanced our capacity for and hierarchy across the sites were refined, Immunosuppressants from 2 million tablets eliminating layers and increasing the shop floor to 10 million tablets/capsules per month by supervision and leadership engagement at the overhauling the equipment. appropriate levels. o We have implemented Track & Trace • Significant progress has been made across all systems in the packaging units in line with facilities with improvement in many key quality global compliance requirements. and supply reliability measures o All our manufacturing equipment has been upgraded to 21 CFR Part 11 compliant, in • We remain committed and steadfast on our line with requirements in the regulated focus to maintain high quality standards and markets. streamlining its manufacturing procedures to ensure compliance with increasing regulatory requirements.
• During the year, our facilities were audited by several regulatory authorities and received the below approvals:
ANNUAL REPORT 2019-20 : MANUFACTURING 12 MANUFACTURING
2. Injectables: 3. APIs: • We handle different packaging formats, such as • Having dedicated API manufacturing facilities vials and pre-filled syringes, and forms, such as is an added advantage as it helps in vertically lyophilized and liquid at our injectable facilities. integrating the company’s manufacturing We are also capable of producing high potency operations and helps to control quality and cost. injectable, particularly oncology products through complex processes. • Two of our facilities, Kurkumbh and Pimpri are dedicated towards API manufacturing. • Our Sanand and Hinjewadi facilities are equipped The Kurkumbh plant has separate blocks that to handle commercial scale manufacturing simultaneously manufacture distinct API’s like of most complex injectable dosage forms i.e. intermediates, iron compounds, general purpose nanosuspension, Liposomal and Long acting API’s and Cytotoxic drugs. injectables. We have commissioned state of art fully automated manufacturing SKID for robust An independent Corporate Quality and process and consistent quality. Compliance team, led by Dr. Steven Hagen, monitors and regulates all activities related to quality, health and safety at our manufacturing facilities, through timely reviews and audits.
13 ANNUAL REPORT 2019-20 : MANUFACTURING HUMAN RESOURCE
At Emcure HR is an architect which aligns human leaner organization structure with better role capital with the continuously changing business clarity. and industry landscape and strategy. Our focus for b) Introduction of Role based Job-Description 2019-20 was in creating a healthy, friendly work (JD) across functional layers resulted in environment and being a forward looking tech- well-defined accountability and responsibility driven HR community. factor. c) Cost center optimization with focused Key Initiatives for 2019-20: objective of precise operational cost bought Manufacturing Organization Structure - Role reduction in operational cost. The new Re-alignment and Optimization Process - system also brought in faster processing of approvals. a) A comprehensive role- mapping exercise was undertaken for all designations resulting in a
ANNUAL REPORT 2019-20 : HUMAN RESOURCE 14 HUMAN RESOURCES
Project Shubharambh: leadership/ behavioural skills. These capability building initiatives cover employees across all grades, This project was initiated with an objective of functions and locations to enhance productivity and creating a talent pipeline at entry level. 50 Fresh sustain a healthy work culture. For FY 19-20 over graduates were picked up from colleges and they 30 plus Lead Programs on behavioral/leadership were put through stringent role- based training for 6 and technical competencies were conducted which months before inducting them on to the shop floor. covered over 6000+ employees. Some highlights are as below: Tech Transformation – HRMS a. Creating coaching culture “Performance Based Introduction of HRMS (Darwin Box) has been a crucial step in making HR a technology driven Coaching: i-COACH programs” were conducted function. Some of the key improvements are: - for Sales Managers from India Business covering more than 350 managers. a. Brought all HR processes on a single platform b. Initiated facilitation of Leadership trainings for which is a leap towards going paperless with Marcan at Canada all-time accessibility to employees through c. Continued to support Tillomed for Learning & mobile enabled applications. Development initiative and conducted trainings b. Migrated the Performance Management at Luton, UK for Tillomed team members System (PMS) to an online process from a d. Conducted Assessment/ Development Center traditional paper-based practice, making it covering 500 plus employees from plants faster, leaner and transparent. and various functions under initiative brand c. A Recognition platform was created where “Emcure: i-Develop” employees can recognize their peers, superiors e. Six Sigma Green belt certification as part of or reports for upholding the core values of Operational excellence for Operation and R&D the company or appreciating/recognizing f. Programs like Design Thinking for new age of individuals. Thinking & Business Financial Acumen “How d. Continuous 360 degrees’ feedback as a tool Do We Make Money” were conducted for was introduced for making meaningful impact managers. in performance of supervisors and managers. g. “Leading with Self-Change – Vikasachi Navi e. Recruitment process was upgraded from Dalne: Phase 4” was conducted for permanent manual filing of requisition form and employee operators at all manufacturing plant of Pune, onboarding formalities to an automated online Kurkumbh & Jammu covering more than 400 process this brought about a noticeable change plus employees in the entire Talent Acquisition process. h. Sales force capability building trainings continued for both HO and field levels Learning and Development employees, covering pan India. Our Corporate L&D and Marketing training team continues to facilitate Learning & Development initiatives to build professional capabilities and enhance employee business technical and
15 ANNUAL REPORT 2019-20 : HUMAN RESOURCE HUMAN RESOURCES
L&D Initiatives at Marcan
Tillomed Team L&D session
Visual Factory Management Training for Operational Excellence Team
Training Session at Hinjewadi manufacturing facility
ANNUAL REPORT 2019-20 : HUMAN RESOURCE 16 HUMAN RESOURCES
Prerna Prerna is a platform where concerted efforts International Women’s Day is celebrated with great are taken by the company to groom our women enthusiasm by the Prerna members wherein they colleagues in their professional career as well as get an opportunity to showcase their theatrical personal lives. talent.
Large number of women empowerment initiatives This year Prerna members also had the opportunity are conducted, exclusively for women Emcureans to interact with Ms. Sudha Menon, a well-known which include interactive sessions by prominent writer who spoke about ‘Reinventing Yourself’ and women personalities, wellness sessions, training Ms. Roopa Purshottam who dwelled on ‘Importance programs, lunch sessions with women leaders of the of Managing Finances’. company.
Interactive session with adolescent girls about personal hygiene Emcure Cricket League 2019-20
Women’s Day celebrations Lunch Session with a woman leader, Manisha Sonavadekar
Ongoing Employee Engagement Initiatives: To foster mental and emotional connect of the Celebrating Pharmacist Day, Engineer’s Day, employees with the company, well-orchestrated Women’s Day in addition to all festivals are the employee engagement initiatives are organized popular events on the Employee Engagement annually which are highly participative and well calendar. The Annual Traditional Day is one of the received by employees at all levels. most popular events, which witnesses the largest participation and is celebrated with great pomp and fervor as glimpsed below:
17 ANNUAL REPORT 2019-20 : HUMAN RESOURCE HUMAN RESOURCES
I. Slow Cycling Competition which demanded clear mix of body balance and strategy. Over 200 employees participated. II. Inter-Unit Box Cricket tournament drew huge response was equivalent to a mini IPL for Emcureans.
Spot Awards ceremony R&R program & Spot Awards ceremony at Hinjewadi
Traditional Day Celebrations Trip to Tikona arranged for manufacturing facility employees
Emcure Cricket league
ANNUAL REPORT 2019-20 : HUMAN RESOURCE 18 MANAGEMENT DISCUSSION & ANALYSIS
Global pharma landscape • Most developed and pharmerging markets will • The global pharma market has experienced see slowing rates of growth in the next five years significant growth and is valued at $1.25 trillion compared to the last five, with rates between (2019). 1-4% and 5-8%, respectively. In developed • Global pharma sales increased at a 3% markets, the projected growth is slowing due to compound annual growth rate (CAGR) since effects of pricing controls and loss of exclusivity 2014, slowing from a 4% rate seen in 2009-2014. and are mildly offset by continued emergence of new therapies.
19 ANNUAL REPORT 2019-20 : MANAGEMENT DISCUSSION & ANALYSIS MANAGEMENT DISCUSSION & ANALYSIS
• Most pharmerging market growth was previously • The industry is facing several challenges this year driven by health care access expansions, resulting – political and economic uncertainty with Brexit, in greater use and adoption of novel therapies. US/China Trade war, upcoming US elections and These include specialty medicines, which are the ongoing COVID pandemic. With US elections projected to contribute more to spending than in coming close, US pharmaceutical pricing issue previous periods. However, most of the products and healthcare reform will gain greater focus. used in these countries are generics, which aid in keeping spending low despite expanding volume. As a result, most countries are projected to have slower growth than historical CAGRs.
Pharma Industry Re enue Pharma Industry Re enue 1500 1500 1250.4 1250 1204.8 1135.1 1250.4 1115.7 1204.8 1250 1063.1 1073.1 1135.1 1000 964.4 993.8 1115.7 963.2 1063.1 1073.1 888.2 993.8 1000 830.6 964.4 799 963.2 750 726.4 888.2 830.6 648.7 799 601.2 750 559.9 726.4 500 498 648.7 427.6 601.2 390.2 559.9 500 498 Re enue in billion U.S. dollars U.S. in billion Re enue 427.6 250 390.2
Re enue in billion U.S. dollars U.S. in billion Re enue 250 0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Global Medicine Net Mar et Si e and Growth 2009-2024, Constant US Bn
Global Medicine Net Mar et Si e and Growth 2009-2024, ConstantForecast US Bn 5-year CAGRs Forecast1115-1145 5-year O erall CAGRs 100-130 955 2-5 5-year 5-year O erall 102 CAGRs CAGRs 777 1115-1145315-345 5-year4.2 1-4 O erall 90 244 O erall 628 CAGRs2-6 100-130 4.3 955 2-5 78 5-year 168 O erall 5-8 95 2.8 7.7 102 CAGRs 777 315-345 4.2 1-4 O erall12.2 90 244 665-695 628 2-6 609 1-4 455 4.3 519 3.3 78 2.6 168 5-8 95 2.8 7.7
2009 2014 2019 2024 12.2 609 1-4 665-695 455 519 3.3 2.6
De eloped Pharmerging Rest of World Global 2009 2014 2019 2024
Source: IQVIA Market Prognosis, Sept 2019; IQVIA Institute, Dec 2019 Notes: Net Market Size after estimated offinvoice discounts and rebates, estimated at country level (See Methodology). De eloped Pharmerging Rest of World Global
Source: IQVIA Market Prognosis, Sept 2019; IQVIA Institute, Dec 2019ANNUAL REPORT 2019-20 : MANAGEMENT DISCUSSION & ANALYSIS 20 Notes: Net Market Size after estimated offinvoice discounts and rebates, estimated at country level (See Methodology). MANAGEMENT DISCUSSION & ANALYSIS
Emerging Trends:
Loss of exclusivity
• The expected impact of losses of exclusivity globally is expected to be $139 billion between 2020 and 2024. • In the next five years, this will help improve health outcomes as generics bring greater availability of medicines at lower cost and will expand access across markets.
De eloped Mar ets Lower Brand In oice Spending Due to Loss of Exclusi ely, Constant US Bn
Forecast -0.8 -1.2 -1.6 -3.1 -8.3 -7.4 -7.1 -6.2 -8.7 -10.8 De eloped Mar ets Lower Brand In oice Spending Due to Loss of Exclusi ely, Constant US Bn -13.3 -20.5 -21.5 -22.0 -14.4 -14.4 -14.9 Forecast-23.8 -0.8 -1.2 -1.6 -16.4-3.1 -8.3 -7.4 -7.1 -6.2 -8.7 -15.4-10.8 -21.2 -21.8 -22.0 -30.2 -22.7 -23.6 -22.7 -26.2 -13.3 -20.5 -21.5 -22.0 -30.0 -14.4 -14.4 -14.9 -23.8 -16.4 -15.4 -39.0 -21.2 -21.8 -22.0 -30.2 -22.7 -23.6 -22.7 -26.2 107 billion 139-30.0 billion
-39.0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Biologoc Losses 107 billion Small molecule losses Total Losses Per Year 139 billion Total Losses
Source: IQVIA Market Prognosis, Sept 2019; IQVIA Institute, Jan 2020 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Specialty medicines Biologoc Losses Small molecule losses Total Losses Per Year Total Losses • Specialty medicines spending isSource: projected IQVIA Market to Prognosis, account Sept 2019; for IQVIA 40% Institute, of globalJan 2020 spending in 2024 and is expected to reach 52%Specialty in 2024 In oice in developed Spending bymarkets. Theorapy New Are specialtyin De elopement products Mar ets, are increasingly Constant US Bn in the niche areas, including oncology and autoimmune therapies. Oncology 104 Autoimmune 61 SpecialtyHIV In oice 29Spending by Theorapy Are in De elopement Mar ets, Constant US Bn Immunology 26 OncologyMS 23 104 AutoimmuneHCV 12 61 ematologyHIV 10 29 ImmunologyAMD 6 26 GM-CSFMS 6 23 HCVESA 612 ematology G 310 All othersAMD 6 67 GM-CSF 6 -20 0 20 40 60 80 100 120 140 160 180 ESA 6 G De eloped3 specialty spending 2019: 354Bn Forecast de eloped specialty growth to 2024: 125-155Bn All others Source:67 IQVIA Market Prognosis, Sept 2019; IQVIA Institute, Jan 2020
-20 0 20 40 60 80 100 120 140 160 180
De eloped specialty spending 2019: 354Bn Forecast de eloped specialty growth to 2024: 125-155Bn
Source: IQVIA Market Prognosis, Sept 2019; IQVIA Institute, Jan 2020
21 ANNUAL REPORT 2019-20 : MANAGEMENT DISCUSSION & ANALYSIS MANAGEMENT DISCUSSION & ANALYSIS
Biosimilars Biosimilars are expected to gain traction over the • Supply chain disruption: With COVID 19 next 5 years. Over the next 5 years $40bn of biologics pandemic, supply chain has come to a grinding will lose patents vs $7bn in last 5 years. halt. The rise in input cost, interruption of production schedules and shut down of factories Regulatory approval process is seeing more clarity has resulted in increased prices. allowing for more competition. China accounts for 20% of world’s API output and Local manufacturing Indian pharmaceutical industry imports 85% of those ingredients from China. Over dependence Local manufacturing focus is seeing increased on China exposes it to price volatility and supply political noise across geographies in the wake of disruptions. The crisis has triggered a need for COVID crisis. US and India both have rolled initiatives backward integration. Also, world businesses to encourage local manufacturing. and leaders are looking for alternative low cost nations to source their supplies and India could Vaccines/Injectable demand possibly benefit from this. Post COVID, vaccine manufacturing has become a focus area. While there are multiple vaccine • Demand of Medicines: Increased unemployment candidates under development, the key bottleneck has negatively impacted consumer spending on is likely to be manufacturing capacity. medicines. Also, with the current focus across nations being on managing the COVID crisis, In this scenario, injectable plant demand could there has been a reduction in spending on see a sharp increase as plants are re-purposed for routine healthcare. injectables. In the near term, we could see a fall in treatment initiation for chronic illnesses. But simultaneously this may cause a steep rise in COVID Impact on the Industry repeat prescriptions as patients stock up in anticipation of a lockdown. The coronavirus (COVID-19) pandemic which originated in China has infected almost 20m people • Delays in Innovation: With pharma companies worldwide and has claimed over 800,000 lives. focusing on crisis management, a number of Despite measures taken by various countries to new clinical trials have been delayed. contain the spread of the virus, it has the potential • Change in interactions with healthcare to create devastating social, economic and political professionals: With lockdowns and travel effects. The widespread closures to contain the restrictions, in-person interactions with spread of the virus have altered the economic healthcare professionals have reduced. landscape. Although, efforts have been made to shift to At present, there is no approved treatment or virtual/online support, they have been accepted vaccine for COVID-19. The uncertainty of the with varying degrees of support across therapy duration of the crisis is likely to shrink the global areas. growth dramatically. Below are a few key trends observed in the pharmaceutical industry:
ANNUAL REPORT 2019-20 : MANAGEMENT DISCUSSION & ANALYSIS 22 MANAGEMENT DISCUSSION & ANALYSIS
The Indian Pharmaceutical Market
• Indian pharmaceutical industry supplies over Revenue of Indian Pharmaceutical 50 per cent of global demand for various Sector US Billion vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicine in the UK. 20 16 India accounts for 20% of global exports of 20.03 18.12 12 generics and India’s pharmaceutical exports 17.87 16.41 stood at $13.69b (up to January 2020). 8 15.53 4 • India’s domestic pharmaceutical market 0 turnover reached Rs 1.4 lakh crore (US$ 20.03 2015 2016 2017 2018 2019 billion) in 2019, growing 10 percent year-on- Source: ibef.org year. • Medicine spending in India is projected to grow 9-12 per cent over the next five years, leading India to become one of the top 10 countries in terms of medicine spending. OPHTHAL / OTOLOGICALS 2% VACCINES 2% ORMONES 2 UROLOGY 1 • As per ICRA, the Indian pharmaceutical industry ANTI-NEOPLASTICS 2 is likely to still grow at 4-6% in 2020-21 despite GYNAECOLOGICAL 5
the challenges faced. Over medium term it still ANTI-INFECTIVES expects Indian pharma to growth at 8-11% over 13 FY20-23 NEURO / CNS 6 CARDIAC • Presently, over 80 per cent of the antiretroviral 13 DERMA drugs used globally to combat AIDS (Acquired 7 Immune Deficiency Syndrome) are supplied by GASTRO INTESTINAL PAIN / ANALGESICS Indian pharmaceutical firms. 11 7 • Indian pharmaceutical sector is expected to grow to US$ 100 billion by 2025. RESPIRATORY 8 VITAMINS/ ANTI DIABETIC MINERALS/ 10 • Indian companies are likely to focus on NUTRIENTS development of specialty medicines or complex 8.54 generics to augment their portfolio and increase share in world exports. IPM – Mix by therapeutic segment • The growth will be led by growth in sales of cardiac medications and anti-diabetes medications, an indicator of the growing burden of chronic lifestyle diseases.
23 ANNUAL REPORT 2019-20 : MANAGEMENT DISCUSSION & ANALYSIS MANAGEMENT DISCUSSION & ANALYSIS
Government Initiatives under which rural and urban people will be benefited. Also, 6,400 crore has been allocated to Healthcare sector is seeing increased focus by the health insurance under Ayushman Bharat – Pradhan Government of India. It has over past few years Mantri Jan Arogya Yojana (AB-PMJAY). The National launched multiple schemes to increase health Health mission scheme is the largest government access and promote the manufacturing sector. Some funded healthcare programme, which is expected of the key government initiatives to promote the to benefit 73m poor families in the country by pharmaceutical sector in India are as below: providing a cover of up to 5lakh per family per year on a floater basis in the impaneled hospitals scross Pharma Vision 2020: It is a Government India. With the COVID pandemic, the Govt. also commitment to make India a global leader not only announced that it will provide health cover of 50 lakh in the production of low cost generic medicines per person to front line health workers, sanitization but also to make it a drug discovery and Innovation staff, paramedics, nurses, and doctors. Adoption of powerhouse in end to end drug manufacturing. As health insurance is increasing in the country and part of the vision, the Government plans to set up further penetration would drive the expansion of a nearly 1 lakh crore fund to encourage companies healthcare services and pharmaceutical market. to manufacture pharmaceutical ingredients domestically by 2023. Jan Aushadhi: The Government has set up Jan Aushadhi Kendras across the country to provide Union Budget focus: Under Budget 2020-21, quality medicines at affordable prices. allocation to the Ministry of Health and Family welfare was increased to $9.3b. The Centre recently Overview has committed Rs. 15,000 crore for health related measures to combat COVID-19 outbreak. Emcure Pharma
FDI: The Union Cabinet has given its nod for the • Emcure is an integrated global company, engaged amendment of existing Foreign Direct Investment in developing, manufacturing and marketing (FDI) policy in the pharmaceutical sector in order to broad range of pharmaceutical products across allow FDI up to 100 per cent under the automatic countries. route for manufacturing of medical devices subject to certain conditions. • The Company has a global presence and sells its products in India, the United States, Canada, Pharmaceutical Parks: GoI is planning to set up bulk Europe and emerging markets including drug parks to reduce dependence on raw material countries in Latin America, Asia Pacific region imports. In Oct’19, Telangana government proposed, and Africa. “Hyderabad Pharma City” with financial assistance from the Central Government. The UP Government • We have around 10,000 + employees with close is also to set up six pharma parks with best in-class to 400 located outside India. infrastructure and technology. • Majority of our revenues are from sales of differentiated pharmaceutical products Pharmaceuticals Purchase Policy (PPP): In developed in-house and those in-licensed by November 2019, the Cabinet approved extension/ leveraging our relationships with multi-national renewal of extant Pharmaceuticals Purchase pharmaceutical companies. Most of these Policy (PPP) with the same terms and conditions are commercialized through our marketing while adding one additional product namely, infrastructure across geographies. Alcoholic Hand Disinfectant (AHD) to the existing list of 103 medicines till the final closure/strategic • The consolidated revenue of the Company was disinvestment of Pharma CPSUs. Rs. 50,486 Mn in FY 20, posting a growth of 7% over previous year, primarily driven by growth in The Government has Growing health insurance: the Domestic and Emerging markets along with allocated $4.8b towards National Health Mission Canada and Europe.
ANNUAL REPORT 2019-20 : MANAGEMENT DISCUSSION & ANALYSIS 24 MANAGEMENT DISCUSSION & ANALYSIS
• Through our portfolio of products, we operate in therapy, 9th in Cardiac therapy, 8th in Vitamins/ multiple therapeutic areas primarily gynecology, Minerals/Nutrients. [Source: AIOCD MAT Mar cardiac, dermatology, anti-infectives, anti- 2020]. Emcure’s 8 brands feature in the Top 300 retrovirals, gastrointestinal, respiratory, Brands of the Indian pharma market. oncology, cardiovascular, pain management and vitamins. • Emcure has a strong field force of 5,000+ professionals that engage with doctors across specialties which has lead Emcure to create its Business performance dominance in the Indian market. Domestic business • At the heart we are committed to providing affordable care and that is evident from our • Emcure’s India business continues to be the recent launch of Vylda (Vildagliptin) with an aim most important market for the company, to offer high-quality and proven-cost-effective constituting 45% of the turnover. Domestic treatment for Type II Diabetes. business contributed Rs.22,918 Mn to revenues, a growth of 12%. Emcure has established its • During the year, Emcure launched products presence in all the major therapeutic areas and primarily under the Gynecology, Vitamins, Anti- created a niche position for itself in the domestic infectives, Hormone and Gastro therapies. market. Rest of the World (ROW): • With our focus on building the width of portfolio, • Revenue from RoW markets was Rs. 5,713 Mn we have become one of the market leaders in in FY20 representing 11% of global revenues. many of the therapy areas that we operate in. Revenues have grown 4% over previous year. • In terms of industry comparison, Emcure is • Our key markets in the RoW markets are Russia, ranked 13th in terms of sales in the domestic Brazil and Mexico. market [Source: AIOCD MAT Mar’2020]. • Growth was led by key launches and market • In terms of therapies, we are ranked No.1 in share gains in CIS and South East Asian markets. HIV , No.1 in Gynecology, 2nd in Blood related
Domestic mix by therapy