`
`I Panacea Biotec
`
`Innovation fr. support‘ of life
`
`
`
`
`Expanding Beyond
`
`HORIZON
`
`Annual Report 2016-17
`
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`

`

`Contents
`
`Corporate Information
`
`Vision, Mission & Values
`
`Chairman's Message
`
`Panacea Biotec at a Glance
`
`Financial Highlights
`
`Core Strengths
`
`Management Discussion & Analysis
`
`Directors' Report
`
`Corporate Governance Report
`
`Auditors' Report on Standalone Financial Statements
`
`Standalone Financial Statements
`
`Auditors' Report on Consolidated Financial Statements
`
`Consolidated Financial Statements
`
`01
`
`02
`
`04
`
`06
`
`07
`
`08
`
`10
`
`25
`
`49
`
`66
`
`72
`
`106
`
`110
`
`Safe Harbour Statement
`This report contains forward-looking statements, which may be identied by their use of words like
`‘plans’, ‘expects’, ‘will’, ‘anticipates’, ‘believes’, ‘intends’, ‘projects’, ‘estimates’, or other words of similar
`meaning. All statements that address expectations or projections about the future, including but not
`limited to statements about Company’s future growth drivers, product development, market
`position and expenditures are forward looking statements. Forward looking statements are based
`on certain assumptions and expectations for future events. The company may not guarantee that
`these assumptions and expectations are accurate and will be realised. The Company’s actual results,
`performance or achievements could thus differ materially from those projected in any forward-
`looking statements. The Company assumes no responsibility to publicly amend, modify, revise any
`forward-looking statements, on the basis of any subsequent developments, information and events.
`
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`

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`Corporate Information
`
`Board of Directors
`Executive Directors
` Mr. Soshil Kumar Jain - Chairman
` Mr. Ravinder Jain - Managing Director
` Dr. Rajesh Jain - Joint Managing Director
` Mr. Sandeep Jain - Joint Managing Director
` Mr. Sumit Jain - Director Operations & Projects
` Mr. Ankesh Jain - Director Sales & Marketing
`Non-Executive Independent Directors
` Mr. R. L. Narasimhan
` Mr. N. N. Khamitkar
` Mr. K. M. Lal
` Mr. O. P. Kelkar
` Mrs. Manjula Upadhyay
` Mr. Mukul Gupta
`Company Secretary
`Mr. Vinod Goel - Group CFO and Head Legal &
`Company Secretary
`Chief Financial Officer
`Mr. Devender Gupta - Chief Financial Officer & Head
`Information Technology
`Registered Office
`Ambala-Chandigarh Highway
`Lalru - 140 501, Punjab, India
`Corporate Offices
`B-1 Extn./G-3, Mohan Co-operative Indl. Estate
`Mathura Road, New Delhi - 110 044, India
`B-1 Extn./A-27, Mohan Co-operative Indl. Estate
`Mathura Road, New Delhi - 110 044, India
`Manufacturing Facilities
`Malpur, Baddi, Dist. Solan
`Himachal Pradesh - 173 205, India
`Ambala - Chandigarh Highway
`Lalru - 140 501, Punjab, India
`
`Information as on May 30, 2017
`
`R&D Centres
`GRAND R&D Centre
`Plot No. 72/3, Gen Block, T.T.C. Indl. Area
`Mahape, Navi Mumbai - 400 710, India
`SAMPANN Drug Delivery R&D Centre
`Ambala-Chandigarh Highway
`Lalru – 140 501, Punjab, India
`LAKSH Drug Discovery R&D Centre
`Plot No. E-4, Phase II, Indl. Area
`Mohali – 160 055, Punjab, India
`OneStream Research Centre
`B-1 Extn./A-24-25, Mohan Co-operative Indl. Estate
`Mathura Road, New Delhi -110 044, India
`Sales & Marketing Office
`7th oor, Sagar Tech Plaza, ‘A’ Wing, Saki Naka,
`Andheri (East), Mumbai - 400 072, India
`Statutory Auditors
`M/s. Walker Chandiok & Co. LLP
`Chartered Accountants, Gurugram, India
`Secretarial Auditors
`M/s. R&D Company Secretaries, Delhi, India
`Cost Auditors
`M/s. G.T. & Co., Cost Accountants, New Delhi, India
`Registrar & Transfer Agents
`M/s. Skyline Financial Services Private Limited
`D-153 A, Ist Floor, Okhla Indl. Area, Phase-I
`New Delhi - 110 020, India
`Banks
`Axis Bank Limited
`Bank of India
`Canara Bank
`IDBI Bank Limited
`Indian Overseas Bank
`State Bank of India
`Union Bank of India
`
`www.panaceabiotec.com
`CIN: L33117PB1984PLC022350
`
`Panacea Biotec Ltd.
`
`1
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`

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`Mission
`Innovation in
`Support of Life
`
`Vision
`Leading Health
`Management
`Company
`
`Our Values
`
`A process which transforms business ideas to marketable products
`Bringing together different functions of the organisation like marketing, nance, R&D,
`manufacturing to meet a common goal
`A 'way of life' in every activity, from administration to innovation
`To challenge every process & solution to discover ways to make them better
`Intolerance towards stability, encouraging continuous change
`Thinking about the impossible and discovering ways to execute it
`Deep rooted and sustainable change and supercial efforts
`
`Honesty
`Ethical practices
`Transparent and clear communication
`Always learning & improving
`
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`

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`Goal
`To Meet Every
`Healthcare Need
`with a
`Panacea Biotec
`Brand and
`Service
`
`Objective
`Take Ideas from
`Grey Cell to
`Markets in a
`Proactive Manner
`
`Striving for leadership in every activity and to become the guiding star
`Having a vision of the future and succeed in reaching there before anyone else
`Persevere in owning innovation and be the rst mover in the market
`Empowering people to speed up the organisation growth
`Always embracing new technology and processes
`Condence to stand apart from competitive organisations
`
`Humility to respect all individuals
`Care for individuals and environment
`Placing betterment of people (external and internal) at the core of each activity
`Core of new developments
`
`Pharmaceutical Formulations Facility, Baddi, Himachal Pradesh
`
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`
`
`
`
`demand for making products more affordable and yet
`develop new drugs through investment in R&D.
`
`During the year, your company has achieved net
`revenues of Rs. 5,301 million despite the challenges
`
`faced by the Company on account of increasing
`price competition in sale of pentavalent vaccine
`
`Easyfive-‘l'l' to UNICEF/PAHO, non-availability of IPV
`bulk, increasing price controls by NPPA, banning of
`irrational FDCs by DCGI and applicability of excise duty
`upon expiry of holiday period at Baddi facilities.
`
`During the financial year 2016-17, your Company has
`earned EBITDA of Rs.1 ,209 million and thefinance costs
`
`have reduced to Rs.1,014 million. The Company's loss
`before tax and exceptional items has reduced to Rs.462
`
`million as against Rs.482 million during FY2015-16 etc.
`The Company's long term debts have reduced by
`Rs.205 million during the year. The Company has
`recently divested its entire stake in its subsidiary
`company viz. NewRise Healthcare Private Limited at an
`enterprise value of Rs.1,800 million and the funds
`received from such divestment have been utilized for
`
`meeting working capital requirements and for
`reduction of debts.
`
`During the year, the Company has received USFDA
`
`approval for its 2"d Abbreviated New Drug Application
`(ANDA), viz. Rizatriptan oral dispersible tablets and has
`recently launched the same in US markets through
`collaboration with Bionpharma Inc., USA thereby
`expanding the existing collaboration with them. In
`addition, the approval process for other ANDAs filed
`earlier with the USFDA is in progress. Your Company is
`also developing more than 10 ANDAs with a target of
`filing during the next 2 years. The Company is in
`discussion with various leading pharma companies for
`launching these products in US, Europe, etc. The
`Company is also building a robust pipeline of around
`25 products for filing in several other emerging
`markets which it will be filing in the next 12-15 months
`
`and aims to improve the accessibility and affordability
`of medicines as the Company's contribution to
`Government of lndia's"MAKE IN lNDlA”mission.
`
`Your Company has entered into a long term award with
`UNICEF for supply of 10 million doses of Easyfive-‘l'l' in
`CY2017 and has also received a notification from Pan
`
`American Health Organization (PAHO) for supply of
`around 5.0 million doses of Easyfive-TT through
`December 2019 with overall value of US$ 20.475
`
`million (around Rs.1,400 million). The Company has
`also secured tenders worth around Rs.144 million for
`
`supply of bOPV to Government of India for FY2017-18.
`The production of bOPV at Company's vaccine
`formulation facility at Baddi has also started.
`
`As a part of the long-term growth strategy, the
`Company is now expanding its sales of recently
`
`launched hexavalent vaccine EasySixTM in India and is
`expediting development of other critical vaccines
`including the pneumococcal vaccine and dengue
`vaccine which are expected to be launched during
`FY2019—20.
`
`Panacea Biotec thrives to make a significant difference
`
`in lives of people everywhere. It works closely towards
`the development of society, in line with its philosophy
`of creating happier and healthier society.
`
`Although the future is full of uncertainty and
`challenges but it is also full of opportunities. As an
`organization we have evolved and we have evolved for
`the better. Let's all gear up and prepare for the better
`days ahead which is not very far away.
`
`With these words, I express my sincere thanks to all our
`stakeholders, bankers, employees, partners, and
`associates for their unbroken support, participation
`and guidance which we continue to count on as we
`forge ahead towards ourdestination.
`
`Best wishes
`
`Soshil KumarJain
`
`
`
`Panacea Biotec Ltd. a
`5
`Panacea Biotec Ltd.
`
`
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`Panacea Biotec
`At a Glance
`
`Panacea Biotec is one of India's leading research-
`based health management companies with
`established capabilities in research & development,
`manufacturing and marketing of pharmaceutical
`formulations, vaccines and biopharmaceuticals.
`Panacea Biotec consistently focuses on providing
`novel and innovative products at affordable
`prices by merging the cutting-edge science and
`technology with its unwavering commitment to
`spread good health and healthy living within the
`reach of the millions of families across the world to
`meet the unmet needs of patients.
`The company has collaborations and tie-ups with
`leading national and international research and
`commercial organizations and pharmaceutical
`
`companies to achieve the mutual aim of better-
`quality healthcare. The company's state of the art
`manufacturing facilities for vaccines and
`pharmaceutical formulations comply with the key
`International regulatory bodies like USFDA, BfArM
`Germany and WHO-cGMP standards. The product
`portfolio includes highly innovative prescription
`products in niche therapeutic areas such as
`diabetes & cardiovascular management,
`oncology, nephrology & transplant management,
`osteoporosis management, gastro-intestinal care,
`pain management products and pediatric
`immunization. The Company has established
`sales and marketing set-up in India and also
`exports its products to more than 30 countries.
`
`
`
`
`
`Global Research and Development Centre (GRAND), Mahape, Navi MumbaiGlobal Research and Development Centre (GRAND), Mahape, Navi MumbaiGlobal Research and Development Centre (GRAND), Mahape, Navi Mumbai
`
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`

`

`2015-16
`
`2014-1
`
`13-14
`
`2012-13
`
`2011-12
`
`2010-11
`
`2009-10
`
`08-09 -
`
`2016-17
`
`Shareholders Related Ratios
`
`Note: Figures in brackets are negative numbers
`
`* Per Equity Share of Re.1 each
`*** 1 USD= 64.85
`
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`

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`Core Strengths
`
`th
`
`Rising from when it started the journey in 1984, Panacea Biotec has established a respectable and honorable position in
`the Indian Pharmaceutical Industry. Panacea Biotec is the 5 largest vaccine producer in India and 15 largest
`biotechnology companies in India as per BioSpectrum Ranking Survey, 2016. In the Indian pharmaceutical industry,
`Panacea Biotec is ranked at 11 position in its represented therapeutic segments and is also amongst the top 60
`pharmaceutical Companies of India as per the AIOCD AWACS (MAT March 2017) sales data. This achievement is based
`on the company's epicenter of strengths, which includes:-
`
`th
`
`th
`
`STATE-OF-THE-ART MANUFACTURING FACILITIES
`
`Panacea Biotec has state-of-the-art cGMP compliant integrated facility for
`manufacturing bulk vaccines, antigens & biopharmaceuticals at Lalru in Punjab and
`for manufacturing vaccines and pharmaceutical formulations at Baddi, Himachal
`Pradesh. The manufacturing facilities are approved by Indian National Regulatory
`Authority (Indian-NRA), USFDA, WHO and many other international regulatory
`authorities of the world. The Company's manufacturing expertise lies in various
`solid, semi-solid & liquid oral dosage forms and vaccines
`
`STRONG BRAND PORTFOLIO
`
`Panacea Biotec's focuses on niche therapeutic segments including organ
`transplantation, nephrology, oncology and diabetes management and strong
`presence in pain & fever, gastroenterology, orthopedics therapies and vaccines in
`the Indian pharmaceutical market.
`The Company's leading brands command signicant market share in their respective
`therapeutic segments. As per the AIOCD AWACS (MAT March 2017) sales data, the
`Company's top selling brands viz. Glizid (including its extensions), PanGraf,
`Mycept, Cilamin and Panimun Bioral are ranked number 1 in their respective
`therapy areas and PacliALL, Sitcom, ThankOD, Livoluk and Nimulid are also
`amongst the top 5 brands in their respective therapeutic areas. With 160 rank,
`Glizid (including its extensions) features among the top 200 brands in India, as per
`the AIOCD AWACS (MAT March 2017) sales data.
`
`th
`
`GROWING COLLABORATIONS & ALLIANCES
`Panacea Biotec has played a pivotal role in global polio eradication in collaboration
`with WHO, UNICEF & PAHO by supplying more than 10 billion doses of oral polio
`vaccine. The Company also has a rich history of successful collaborations, ventures
`and business relationships with various bodies including several national/
`international research institutes, academic universities and commercial
`corporations, which is a key competitive strength for the Company. The Company is
`also developing several other critical products including the sabin IPV & dengue
`vaccine and several difficult to develop generics etc. under such collaborations.
`
`8
`
`Annual Report 2016-17
`
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`

`

`Think Medicine
`Think India
`
`ESTABLISHED R&D CAPABILITIES
`
`HIGHLY SKILLED & MOTIVATED TEAM
`
`QUALITY ASSURANCE
`
` Panacea Biotec is amongst leaders in the fast growing research based health
`management companies. The Company has four distinguished state-of-the-art
`multi-disciplinary research & development centers that specialise in the elds of
`new Vaccine Development, Biopharmaceuticals, Proteins, Peptides, Monoclonal
`Antibodies, Novel Drug Delivery Systems, Advanced Drug Delivery System and Drug
`Discovery (small molecules) complying with international regulatory standards
`where around 90 scientists work with enthusiasm, dedication and full devotion
`towards the company's objective of taking ideas from grey cell to the market in a
`proactive manner. All our four R&D centers have been accorded registration by
`Department of Scientic and Industrial Research, Ministry of Science & Technology,
`New Delhi.
`
` At Panacea Biotec employees are the core strength of its continual progress and
`endeavor to excel at its best in every segment and thus extending all possible
`support to its employees to make them achieve their goal in order to achieve the
`Organizational goal while keeping an eye on our set Vision & Mission.
`Organization has a total manpower of around 2500 employees out of which 410 are
`skilled employees including Corporate & Managerial staff, Sales staff and staff
`located at our Manufacturing facilities. There are around 90 scientists engaged in
`R&D Centres, around 543 employees engaged in Production, Quality Control &
`Quality Assurance and around 1146 employees engaged in Logistics, Sales &
`Marketing.
`
`Quality is the way of life at Panacea Biotec. Its state-of-the-art manufacturing
`facilities for vaccines and pharmaceutical formulations comply with various key
`international regulatory standards like WHO cGMP, USFDA, BfArM Germany etc. to
`name a few. Committed to Total Quality Management, quality is in-built in
`products & services and it is integrated in each step of R&D, production,
`packaging, storage, marketing, sales & distribution at the Company. This has led
`the Company to achieve prestigious WHO pre-qualication for its pentavalent
`vaccine Easyve-TT, USFDA approval for its oral solid dosage facility & oncology
`facility and several other major milestones in its journey towards excellence.
`
`Panacea Biotec Ltd.
`
`9
`
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`

`

`Management Discussion & Analysis
`
`Segmentation of the Indian vaccine industry
`
`60%
`
`24%
`
`16%
`
`Domestic Market (Locally produced)
`
`Domestic Market (Imported)
`
`Export Market
`
`Vaccination coverage has received a high level of Indian
`government attention in recent past. The government
`initiative, “Mission Indradhanush”, targets expanding the
`full vaccination coverage from 65% to 90% of children of the
`country by 2020. Global Alliance for Vaccines and
`Immunization (GAVI) has allocated a funding support of upto
`US$ 500 million for immunization program in India for the
`period 2017-2020. This coupled with the sustained growth of
`the Indian economy, a consequent rise in public and private
`healthcare expenditures and increasing awareness of the
`benets of immunization in protection against multiple
`diseases is expected to propel the Indian market to grow at a
`CAGR of over 15% in the coming years.
`Global Pharmaceutical Market
`After remaining stable in the last few years, the Global
`Pharmaceutical Industry is now witnessing a more uniform
`and predictable annual growth of around 6%. According to
`Quintiles IMS Institute, the global medicine spending will
`reach nearly US$ 1.5 trillion by 2021 on an invoice price basis,
`growing at a CAGR of 4-7%, up nearly US$ 370 billion from
`2016 estimated spending level. The moderate growth in the
`Global Pharmaceutical Industry over the next ve years will
`be marked by resurging US pharmaceutical market and
`strong growth from other emerging markets.
`
`Growth Constant US$
`
`10%
`
`8%
`
`6%
`
`4%
`
`2%
`
`0%
`
`Y10 Y11 Y12 Y13 Y14 Y15 Y16 Y17P Y18P Y19P Y20P Y21P
`Growth
`Spending
`Global Market Spending and Growth
`Source: Quintiles IMS Institute
`
`1,600
`1,400
`1,200
`1,000
`800
`600
`400
`200
`-
`
`Spendind US$ billion
`
`Key therapy areas driving spending and growth over the next
`ve years will be led by oncology, reaching US$ 120-135
`billion in spending in major developed and emerging
`markets. Diabetes management will continue to evolve with
`introduction of better innovative & convenient formulations,
`
`INDUSTRY STRUCTURE & DEVELOPMENTS
`Global Vaccine Market
`Vaccines have created an incredible impact on global health
`system resulting in signicant reduction of mortality and
`morbidity caused by numerous diseases. Vaccines have led to
`some of the greatest public health achievements ever,
`including the eradication of naturally occurring smallpox
`from the globe and the near eradication of polio.
`The Global Vaccine Market has been one of the fastest
`growing segments of the global healthcare industry. It was
`estimated at US$ 32 billion in 2016 and is expected to grow to
`US$ 52 billion by 2022 growing at a CAGR of 8.3%.
`The high growth in vaccine industry has been driven by
`several factors including inclusion of several pediatric
`vaccines in the national immunization schedule of various
`countries, growing public awareness, funding and other
`support from both government and non-government
`agencies and increasing availability of vaccines at affordable
`prices.
`The increasing demands in emerging countries, the
`changing business landscape, the development of new
`vaccines and the appearance of new technologies for their
`administration are transforming the world of vaccines. At
`present, North America, with about 49% market share, is the
`largest vaccine market followed by Europe, with 31% share.
`However, the future demand and signicant revenues for
`vaccines is expected to come from India, China and other
`emerging countries with a sizeable birth cohort. As per WHO,
`the demand side of the vaccine market is mainly driven by
`governments of industrialized and developing countries,
`pooled procurement agencies, the private sector, and the
`various regulatory and advisory bodies overseeing vaccine
`quality and safety.
`Indian Vaccine Market
`India has become the Vaccine epicenter of the developing
`world. The Indian Vaccine Industry Exemplies the spirit of
`the 'Make-in-India' Programme and stands on a strong
`pedestal of domestic manufacturing success. Besides being a
`global vaccine manufacturing hub, vaccines is also one of the
`few sectors where India has historically enjoyed domestic
`self-sufficiency. The vaccine industry has time and again,
`broken affordability barriers, addressed technology
`challenges and has earned India the recognition of having
`the largest global capacity for WHO pre-qualied vaccines
`manufacturing.
`The vaccines produced by Indian companies are used for the
`National Immunization and in around 150 countries globally,
`which makes India a major vaccine supplier, with one in three
`vaccines across the world being made by Indian companies.
`
`The Indian vaccine industry is estimated to be around US$ 1
`billion with the following segments:
`
`10
`
`Annual Report 2016-17
`
`Apotex v. Abraxis - IPR2018-00152, Ex. 1029, p.12 of 148
`
`

`

`exports are expected to reach US$ 40 billion by 2020. The
`Indian Pharmaceutical Market is US$ 36.7 billion in 2016 and
`is expected to grow at a CAGR of 15.92% during 2016-2020 to
`reach a size of US$ 55 billion. The future growth will be driven
`by changing lifestyle, increasing consumer spending, faster
`urbanisation and rising healthcare insurance among others.
`
`60
`
`50
`
`40
`
`30
`
`20
`
`10
`0
`
`55
`
`36.6
`
`30
`
`CAGR: 15.92%
`
`12
`
`6
`
`2020E
`2005
`2013
`2016
`2015
`Revenue of Indian pharmaceutical sector (US$ billion)
`Source: IBEF
`
`th
`
`PANACEA BIOTEC BUSINESS SEGMENTS
`PHARMACEUTICAL FORMULATIONS
`Panacea Biotec has continued to maintain its leadership
`position in niche therapeutic segments including organ
`transplantation, nephrology, oncology and diabetes
`management and strong presence in pain & fever,
`gastroenterology and orthopedics therapies in the Indian
`pharmaceutical market.
`Panacea Biotec is ranked at 11 position in its represented
`therapeutic segments and is also amongst the top 60
`pharmaceutical Companies of India as per the AIOCD AWACS
`(MAT March 2017) sales data.
`The Company's leading brands are well recognized and
`respected by the medical fraternity and command signicant
`market share in their respective therapeutic segments. As per
`the AIOCD AWACS (MAT March 2017) sales data, the
`Company's top selling brands viz. Glizid (including its
`extensions), PanGraf, Mycept, Cilamin and Panimun Bioral
`are ranked number 1 and PacliALL, Sitcom, ThankOD,
`Livoluk and Nimulid are amongst the top 5 brands in their
`th
`respective therapeutic areas. With 160 rank, Glizid
`(including its extensions) features among the top 200 brands
`in India, as per the AIOCD AWACS (MAT March 2017) sales data.
`As per the AIOCD AWACS (MAT March 2017) sales data, the
`Company's key brands across therapeutic categories and
`their market ranking in India are as follows:
`
`Therapy
`Brands
`Glizid (incl. extensions)
`Anti-Diabetic
`Anti-Neoplastics*
`PanGraf
`Mycept
`Anti-Neoplastics*
`Anti-Neoplastics*
`Panimun Bioral
`Oncology
`PacliALL
`Pain / Analgesics
`Nimulid
`Varicose Therapy
`Sitcom
`Varicose Therapy
`ThankOD
`Livoluk
`Gastro Intestinal
`*Immuno-suppressant Piles management
`Note: Rank is calculated within its therapeutic category or the immediate
`market (wherever applicable).
`
`#
`
`#
`
`#
`
`Rank
`
`1 1 1 1
`
`2
`3
`
`3 4 4
`
`Panacea Biotec Ltd.
`
`11
`
`with differentiated delivery systems expected in the next ve
`years as well as wider adoption of biosimilar in major
`developed markets.
`The lifestyle related therapies viz. oncology, anti-diabetics
`and pain management medications have continued to be
`amongst the top 5 global therapeutic segments in 2016 with
`US$ 75.3, 66.2 and 67.9 billion, respectively and have
`achieved a CAGR growth of 11%, 16% and 7%, respectively
`for the period 2011-16.
`
`Therapy areas
`
`
`Oncology
`Diabetes
`Autoimmune
`
`Pain
`Cardiovascular
`Respiratory
`Antibiotics
`and Vaccines
`Mental Health
`
`HIV
`Antivirals EX-HIV
`All others
`
`Spending
`2016
`75.3
`66.2
`45.1
`67.9
`70.5
`54.4
`54.4
`
`36.8
`24.6
`33.2
`230.2
`
`2011-16
`CAGR
`10.9%
`16.4%
`18.2%
`7.1%
`-2.5%
`3.4%
`2.5%
`
`-5.0%
`11.5%
`38.1%
`5.5%
`
`Spending
`2021
`120 - 135
`95 - 110
`75 - 90
`75 - 90
`70 - 80
`60 - 70
`60 - 70
`
`35 - 40
`35 - 40
`35 - 40
`360 - 415
`
`2016-2021
`CAGR
`9 - 12%
`8 - 11%
`11 - 14%
`2 - 5%
`0 - 3%
`2 - 5%
`2 - 5%
`
`(-1) - 2%
`6 - 9%
`0 - 3%
`4 - 7%
`
`Outlook of leading therapy areas spending and growth, Constant US$ billion
`Source: Quintiles IMS Institute
`
`rd
`
`Over the last few years, generic and low-cost branded
`generic formulations have been gaining in terms of volume
`as well as market share. The global generic drugs market is
`expected to grow at a CAGR of 10.53% from 2016 through
`2020. In fact, according to market reports, the global generic
`drugs market will benet from the patent expiry of drugs
`worth US$ 150 billion by 2020.
`Indian Pharmaceutical Market
`Indian Pharmaceutical Industry has achieved a key position
`in the global pharmaceutical industry. With largest number
`of USFDA approved facilities outside USA, India continues to
`play a pivotal role in supply of affordable and quality
`pharmaceutical products to the world. The Indian
`Pharmaceutical Market accounts for 2.4% of the global
`pharmaceutical industry in value terms and 10% in volume
`terms as per the India Brand Equity Foundation (IBEF). It is the
`3 largest in terms of volume and 13 largest in terms of
`value. By 2020, India is likely to be among the top three
`th
`pharmaceutical markets by incremental growth and 6
`largest market globally in absolute size.
`Indian manufacturers are among the most important
`suppliers of generic drugs to USA and several other countries
`and key contributors to the WHO Prequalication Program
`(PQP), which ensures the safety and efficacy of medicines by
`setting standards for generic drugs. Indian manufacturers
`supply more than 65-70% of medicines in the WHO
`Prequalied List of Medicinal Products in the segments of
`HIV-AIDS, Tuberculosis, Malaria, Reproductive Health and
`other categories.
`Indian pharmaceutical industry has evolved signicantly in
`the last ten years. India accounts for 20% of global exports in
`the generic medicines (largest provider of generic drugs)
`with US$ 16.89 billion of exports during FY2015-16. The
`
`th
`
`Apotex v. Abraxis - IPR2018-00152, Ex. 1029, p.13 of 148
`
`

`

`The net turnover of pharmaceutical formulations business
`has grown at a CAGR of around 5.5% to Rs.3,490.3 million in
`FY2016-17 from Rs.2,398.9 million in FY2009-10.
`Your Company has increased its footprint in International
`markets and is currently in the process of launching new
`products across different countries such as US, Germany, CIS
`countries, Brazil, Middle-East and other emerging South-East
`Asian Countries.
`Domestic Pharmaceutical Formulations
`The Company’s pharmaceutical formulations business in
`India is managed by six Strategic Business Units (SBUs) - 3
`SBUs for super specialty business viz. Transplantation &
`Immunology, Nephrology and OncoTrust and 3 SBUs for
`acute & chronic care business viz. Diacar Alpha, Procare and
`Growcare.
`The Company also has a dedicated SBU, Capacity Utilisation &
`Business Enhancement (CUBE) for managing the out-
`licensing and contract manufacturing business.
`As per AIOCD AWACS (MAT March 2017) sales data, the
`therapy-wise market share and sales in India is as under:
`
`1151
`
`5
`
`1334
`168
`
`195
`
`229
`
`287
`
`383
`
`ANTI-NEOPLASTICS
`
`ANTI-DIABETIC
`
`PAIN/ANALGESICS
`
`VARICOSE THERAPY
`
`VACCINES
`
`BLOOD RELATED
`
`NUTRIENTS
`
`GASTRO INTESTINAL
`
`ANTI INFECTIVES
`
`893
`
`Therapy-wise sales in Rs. million
`
`33%
`
`24%
`
`10%
`
`ANTI-NEOPLASTICS
`
`ANTI-DIABETIC
`
`PAIN / ANALGESICS
`
`VARICOSE THERAPY
`
`VACCINES
`
`BLOOD RELATED
`
`NUTRIENTS
`
`GASTRO INTESTINAL
`
`3%
`
`ANTI-INFECTIVES
`
`1%
`
`8%
`
`8%
`
`7%
`
`5%
`
`0
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`Therapy wise market share %
`
`Transplant & Immunology SBU
`India has made signicant progress in the eld of solid organ
`transplantation. At present around 9,300 transplants are
`done annually including around 7,300 kidney, 1,950 liver &15
`heart transplants vis-à-vis a requirement of 200,000 kidney,
`50,000 liver and 50,000 heart transplants every year.
`
`Transplant & Immunology SBU has been supporting
`transplant recipients and promoting cadaveric organ
`donation through various initiatives, with a goal to enhance
`
`12
`
`Annual Report 2016-17
`
`awareness for deceased organ donation in the society, thus
`laying a foundation of holistic well-being across the nation.
`The endeavor of Transplant & Immunology SBU has been to
`provide high-quality medicines at an affordable cost thereby
`improving the quality of life of transplant recipients. The SBU
`continues to be the leader in this market since 2008 with a
`market share of over 24% amongst various multinational and
`local players.
`The main brands of the SBU viz. PanGraf, Mycept group and
`Panimun Bioral continue to be at number one position in
`their respective therapeutic category, as per the AIOCD AWACS
`(MAT March 2017) sales data. PanGraf has maintained its
`leadership position in Tacrolimus market in India since more
`than a decade with around 70% market share as per AIOCD
`AWACS (MAT March 2017) sales data.
`The SBU also caters to the critical therapy areas of anti-infective
`(VagaCyte), adjunct immuno-suppressants (Siropan &
`EverGraf ) and anti-metabolites (Imuza) with an aim to
`provide complete and holistic management of all aspects of
`solid organ transplantation.
`Nephrology SBU
`India is the diabetic capital of the world with around 75
`million diabetic population out of which 30% will develop
`Chronic Kidney Disease (CKD) and presently around 17% of
`the Indian population has some form of CKD.
`The Nephrology SBU with its vision to be the 'Most Reliable
`Partner in providing end to end solution in CKD Management
`is catering to the needs of CKD patients right from stage II to
`5D at all stages. The SBU is committed to provide quality
`products in management of renal anemia, CKD-MBD, renal
`nutrition and hyperkalemia. With the recent launch of novel
`phosphate binder FericPan (Ferric Citrate), the Nephrology
`SBU now offers all the phosphate binders for better patient
`compliance.
`The SBU aims to be amongst top 6 players by FY2017-18 in a
`highly competitive market with more than 40 players. It is
`committed in building up a strong equity amongst 1,500
`Nephrologists & Physicians pan India with its dedicated eld
`force through continuous scientic programs & academic
`initiatives.
`OncoTrust SBU
`Cancer has become one of the leading causes of morbidity
`and mortality worldwide. Globally nearly 14 million new
`cancer cases are detected every year with 8.2 million cancer
`related deaths. The number of new cases is expected to rise
`by about 70% over the next 2 decades. The rate is increasing
`as life expectancy has increased and also lifestyle changes
`occur in the developing world. Most common types of cancer
`in males are prostate, lung, colorectal and stomach, and in
`females are breast, colorectal, lung and cervical cancer.
`Panacea Biotec through its OncoTrust SBU has established
`itself as an organization aiming to deliver quality,
`contemporary and affordable medicines to improve the
`quality of life of cancer patients. With its portfolio of products,
`OncoTrust is well positioned to serve the increasing number
`of cancer survivors in the country. With a dedicated eld force
`across the country, it is covering almost 1,800 Oncologist and
`all major Government and Corporate hospitals.
`
`Apotex v. Abraxis - IPR2018-00152, Ex. 1029, p.14 of 148
`
`

`

`Panacea Biotec was the rst Indian company to launch
`PacliALL a brand of nab Paclitaxel, for the management of
`breast cancer. PacliALL, which was awarded with Brand of the
`Year Award 2011 by Bio-Spectrum, has now become No.1
`brand in nab-paclitaxel market and has saved the lives of
`more than 7000 patients till now, and is one of the most
`admired brand for the treatment of breast cancer.
`
`Panacea Biotec had, last year, launched India's rst
`indigenou