As we enter our 50th year, to see this as a milestone only in Lupin’s history would be too limiting – our past, present and our future is entwined with the growth of the Indian Pharma industry. Our footprint on the global market, the leadership that we have shown in each of our key markets and the vision that we have set for the future are big signs telling the world that we matter.
Our understanding of the major forces shaping our world gives us the know-how to respond for the good of our organization and for Society as a whole. Lupin has a deep-rooted commitment to being truly world-class in everything we do.
At the heart of our business commitments, lies our responsibility to you, our key stakeholders. It is this responsibility that drives us to attain a leadership position in this ever-changing world. At Lupin, we intend to lead the way by doing cutting edge research and building world class capabilities, be they in supply chain, manufacturing or commercialization. Our plans are fueled by a consistent focus on execution, people processes and strategy. The global pharmaceutical market is evolving rapidly – I believe we are ready for this new future.
While I am grateful for the past, I look forward with confidence to the future. My confidence stems from the fact that we have a strong and committed Management Team carrying forward my vision for the Company and the high level of passion and resilience to succeed that I see in each one of them. The Lupin Spirit that embodies all Lupinytts has made Lupin great and will continue to be our underlying strength and enable us to achieve still higher levels of performance in the time ahead.
The journey has been exciting – the future is even more glorious. We will use the optimism that we have and the momentum that we have generated along with the memories and lessons of the past to guide us towards new horizons.
Annual Report 2017
WE ARE ONE OF THE PRIVILEGED FEW THAT HAVE THE FUNDAMENTALS IN PLACE TO SHAPE A BETTER FUTURE FOR SOCIETY, TO MAKE THE WORLD HEALTHIER AND HAPPIER. TO BUILD A BETTER TOMORROW. WE EMBRACE THIS NOT AS A RESPONSIBILITY BUT AS AN OBLIGATION.
-Dr. Desh Bandhu Gupta
(Founder & Chairman)
(8.2.1938 – 26.6.2017)
- Dr. Desh Bandhu Gupta, Chairman
- Mrs. Manju. D. Gupta, Executive Director
- Dr. Kamal K. Sharma, Vice Chairman
- Ms. Vinita Gupta, Chief Executive Officer
- Mr. Nilesh Gupta, Managing Director
- Mr. Ramesh Swaminathan, Chief Financial Officer & Executive Director
- Dr. Vijay Kelkar, Independent Director
- Mr. R. A. Shah, Independent Director
- Mr. Richard Zahn, Independent Director
- Dr. K. U. Mada, Independent Director
- Mr. Dileep C. Choksi, Independent Director
- Mr. Jean-Luc Belingard, Independent Director
- Dr. Desh Bandhu Gupta, Chairman
- Dr. Kamal K. Sharma, Vice Chairman
- Ms. Vinita Gupta, Chief Executive Officer
- Mr. Nilesh Gupta, Managing Director
- Mr. Ramesh Swaminathan, Chief Financial Officer & Executive Director
- Dr. Rajender Kamboj, President – Novel Drug Discovery & Development
- Mr. Naresh Gupta, President – API & Global TB
- Mr. Alok Ghosh, President – Technical Operations
- Dr. Cyrus Karkaria, President – Biotechnology
- Mr. Sunil Makharia, President – Finance
- Mr. Yugesh Goutam, President – Global Human Resources
- Mr. Debabrata Chakravorty, President – Global Sourcing & Contract Manufacturing
- Mr. Rajeev Sibal, President – India Region Formulations
- Mr. Paul McGarty, President – Lupin Pharmaceuticals Inc., USA
- Dr. Sofia Mumtaz, Head – Pipeline Management and Legal
- Mr. Martin Mercer, President – Latin America
- Dr. Thierry Volle, President – Europe, Middle-East & Africa
- Dr. Fabrice Egros, President – Asia Pacific & Japan
- Dr. Kurt Nielsen, President – Somerset, USA
- Mr. Noriaki Tsunoda, President – Kyowa Pharmaceutical Industry Co., Ltd., Japan
Mr. R. V. Satam
B S R & Co. LLP
Ernst & Young LLP
Price Waterhouse & Co., Bangalore LLP
Dr. K. U. Mada, Chairman
Dr. Kamal K. Sharma
Mr. Dileep C. Choksi
NOMINATION AND REMUNERATION COMMITTEE
Dr. K. U. Mada, Chairman
Mr. R. A. Shah
Mr. Richard Zahn
STAKEHOLDERS’ RELATIONSHIP COMMITTEE
Dr. Vijay Kelkar, Chairman
Dr. K. U. Mada
CORPORATE SOCIAL RESPONSIBILITY COMMITTEE
Dr. Desh Bandhu Gupta, Chairman
Dr. Kamal K. Sharma
Mr. Nilesh Gupta
Dr. Vijay Kelkar
RISK MANAGEMENT COMMITTEE
Dr. Kamal K. Sharma, Chairman
Ms. Vinita Gupta Mr. Nilesh Gupta
Mr. Ramesh Swaminathan
Mr. Sunil Makharia STRATEGIC ADVISORY BOARD
Mr. Jean-Luc Belingard
Mr. Franceso Granata
Ms. Yvonne Greenstreet
Mr. Paul Edick
Mr. Arvind Bothra Head – Investor Relations and M&A
Mr. Pradeep Bhagwat General Manager – Investors’ Services
- Vinita Gupta and Nilesh Gupta awarded the ‘Entrepreneur of the Year’ at Forbes India Leadership Awards – 2016
- Vinita Gupta awarded ‘Outstanding Woman Business Leader of the Year’ at 11th CNBC India Business Leader Awards – 2016
- Vinita Gupta enters the Hall of Fame – Most Powerful Women in Business by Business Today – 2016
- Ramesh Swaminathan awarded Best CFO for Best Inorganic Growth Strategy at Yes Bank – BW Businessworld Best CFO Awards – 2017
- Outstanding Company of the Year – CNBC TV18 – 2016
- Lupin named in the Forbes Global 2000 – World’s Most Powerful Public Companies – 2017
- Lupin is yet again Great Place to Work certified Company & leads the Biotech and Pharma industry as the Best Place to Work for, India – 2017
- Golden Peacock Award for Excellence in Corporate Governance – 2016
VICE CHAIRMAN's LETTER
Last few years have been particularly challenging for the industry – a period in which there were several changes in the pharmaceutical eco-system and the market as we know it. An influx of new players, consolidation of channel partners and a more rigorous compliance regime imposed by the regulators have necessitated a change in the industry business model. Further, a slowdown in generic market opportunities and rising pressure from governments across the globe to lower drug prices have impacted sentiments for the industry – we clearly stand at an inflection point.
Lupin has always been quick to adapt to market changes as reflected in our tremendous track record. In the past ten years alone, we have seen eight-fold increase in revenues whilst the market cap went up by thirteen times. This growth has been an outcome of meticulous planning, differentiated strategies, complex products and disciplined execution across markets. I am proud to be a part of this talented team which is capable of embracing hard challenges and steering growth.
Moving forward, we will consolidate on our generics portfolio while focusing on complex generics and specialty products. We expect to rise to this challenge with appropriate acquisitions, calibrated investments in R&D, supported by the right skill sets. This would enable us to enhance the quality of our business and transcend from the existing paradigm towards new horizons.
Our competent and motivated teams, their innovation capabilities backed by appropriate financial horsepower give me immense faith and confidence in the future as we look to expand our global footprint and add greater value to all Lupin stakeholders.
As we move towards the new growth trajectory, I commend the team for their undying commitment, dedication and zeal in shaping the future despite the volatility.
CEO & MD's LETTER
FY 2017 was a record year. We accelerated Lupin’s transformational journey and succeeded in maintaining a sharp focus on our core strategy of building and monetizing a healthy product pipeline, consolidating our investments in new acquisitions and aligning our business operations to the rapidly changing market dynamics.
In the year, our efforts were directed towards building internal resilience as our markets got tougher both on the economic and regulatory front while also strengthening our capabilities through investments in research and development. We witnessed an intense regulatory and pricing regime through the year. However, through proactive efforts of bringing the right products to market and building strong compliance and quality, Lupin steered ahead and gained market leadership in all our key geographies. We now are the 2nd largest Indian pharmaceutical company by sales, rank 4th in the US by prescriptions (5.3% market share – IMS Health) and are the 6th largest generic pharmaceutical player in Japan (IMS Health).
FY 2017 recorded the highest-ever investment in research and development with new developments in complex generics like Inhalation, Biosimilars and Complex Injectables. Through the continued focus on R&D, we now have 368 ANDA filings with the US FDA, of which 214 have been approved to date. We also have 45 First-to-File (FTF) filings including 23 exclusive FTF opportunities.
In FY 2017, Lupin’s Net Sales increased by 24% to ₹ 171,198 million; EBITDA stood at ₹ 45,997 million and our Net Profits were ₹ 25,575 million. Lupin is today the 4th largest generics company globally by market capitalization (March 31, 2017, Bloomberg) and the 6th largest generics pharmaceutical company globally by sales (March 31, 2017, Bloomberg).
There were multiple milestones that we hit during the year. An important one was the acquisition of the branded product portfolio from Shionogi in Japan which comprised of 21 long-listed products across therapy areas such as Central Nervous System (CNS), Oncology, Cardiovascular and Anti-Infectives. This acquisition marks Lupin’s strategy of hybridizing our business model into a healthy mix of generics and branded products in Japan. We also made significant headway in integrating some of our recent acquisitions like Gavis, Medquimica and Temmler and remain optimistic on the potential synergies we will achieve from our inorganic efforts across all Lupin entities.
As we move ahead, our strategy is clear – consolidate on the generic position we have created across our key geographies while building a meaningful specialty business. We will do this through building superiority in R&D, ensuring impeccable quality and compliance and commercial excellence while continually striving to be an employer of choice. We are poised to continue to grow our business in the mid to long term while making a difference.
THE PERFORMANCE MATRIX
The Company has transitioned the basis of accounting from Indian generally accepted accounting principles (“IGAAP”) to Ind AS with effect from April 1, 2016. Hence, numbers are not strictly comparable.
The United States remains Lupin’s largest and most important market with 48% share of total revenues. The Company’s US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) delivers high-quality, branded and generic medicines trusted by healthcare professionals and patients across US. Lupin has built strong relationships in the US wholesale and retail channels with a reputation of reliability and high service levels and being a preferred supplier to the customers.
In addition, Lupin has gained a special consideration amongst pediatric specialists, primary care physicians and the OB/GYN women’s health community with a dedicated field force to promote our branded product portfolio. Backed by strong commercial capabilities in the US market for both branded and generic products, Lupin is uniquely positioned to execute its growth strategy built on niche products, world-class research, manufacturing and supply chain capabilities, protected by strong Intellectual Property rights.
In March 2016, the Company completed its acquisition of US-based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). This strategic acquisition enhances Lupin’s scale in both, the US generics and brands market as well as broadens our pipeline in dermatology, controlled substance products and other niche generics. The acquisition brings to Lupin a highly skilled Manufacturing & Research organization in Somerset, New Jersey, which adds to our Coral Springs, Florida based R&D centre for Inhalation. The New Jersey facility, rechristened as Lupin Somerset, is the Company’s first manufacturing site in the US. During FY 2017, the Company completed the integration of its Somerset site into its established business platforms for commercial, supply chain, manufacturing and R&D operations.
FY 2017 marked a new milestone for Lupin, as our US revenues surpassed the USD 1 billion mark, closing at USD 1,207 million, a growth of 37% over FY 2016 revenues of USD 883 million. The revenues from our Brands business were USD 78 million, while the Generics business clocked in revenues of USD 1,129 million.
With a 5.3% market share by prescriptions (IMS NPA Audit), Lupin is the 4th largest generic company in the US, gaining a rank over last year. Lupin’s success in the competitive generics market can be attributed to its focus on sales to gain market share based on reliability and service levels. This is exemplified in the performance as 45 of the 130 generic products marketed by Lupin were ranked No. 1 by market share while 83 of them were in the top 3 by market share (IMS Generics Module, March 2017). To sustain our growth, we maintain a sharp focus on growing the market share of existing products while continuing new product introductions. We leverage our robust supply chain and continuously engage our trade partners and customers to maintain industry-leading response time. This helps Lupin to stay ahead of the curve and be the best in terms of fill ratios in the US market.
The Company filed 37 ANDAs and one 505(b) (2) NDA in the US market during FY 2017 and currently has 154 ANDAs pending approval, addressing a total market size of over USD 74.9 billion. Of these, 28 ANDAs are first-to-file opportunities addressing a market size exceeding USD 13.1 billion. This includes 14 exclusive first-to-file ANDAs targeting a market size of approximately USD 2.6 billion.
An increase in competition in certain exclusive and semi-exclusive products and consolidation among customers resulted in heightened generic pricing pressure. Despite the same, Lupin posted a 34% rise in revenues during FY 2017 to USD 1.1 billion which is an increase of USD 288 million over the previous year. During the year, 18 new products were launched including the successful commercialization of an exclusive generic version of Mibelas® 24 Fe.
US Brands business is one of Lupin’s key differentiators. The Company repositioned the brands business to emerge as a formidable growth driver in the coming years. At the beginning of FY 2017, the Lupin brands team repositioned and began promoting two new products from the GAVIS portfolio – Methergine® and Methylphenidate. In FY 2017, these new brands contributed USD 44 million and drove total brands business revenues to USD 78 million, an 86% increase over FY 2016.
US FORMULATION REVENUES
In order to provide renewed focus on the US brands business and in support of the Methergine® opportunity, we reorganized and “right-sized” the brands business into two segments based on therapeutic focus. Now, the Pharma sales force primarily promotes Antara® and Suprax® capsule brands, while the Specialty Hospital sales force focuses on promotion of Methergine® in the women’s health space. This realignment will help reinforce our presence in the US branded market and build a platform for sustained future growth.
Generic competition to our flagship Suprax OS brand resulted in 33% decline in our Suprax® branded franchise revenues. On the positive side, sales of the exclusive Antara® 90 mg brand witnessed a surge in sales by 36% compared to the previous year.
In the first quarter of FY 2017, Lupin re-introduced Methergine® (methylergonovine maleate) Oral Tablets 0.2 mg for the prevention and management of postpartum hemorrhage (PPH). Methergine® is the sole oral uterotonic approved by the FDA and is the favored oral agent to manage PPH, according to guidelines issued by the American Congress of Obstetricians and Gynaecologist (ACOG). Majority of maternal deaths occur within 24 hours of birth, most commonly from excessive bleeding. Maternal mortality in the US are on the rise, where PPH is a leading cause of pregnancy complications. With Methergine®, Lupin’s Specialty Hospital Division is making a significant investment to help improve the management of PPH, providing professional medical education, leveraging a new specialized sales force to drive better awareness and access to care, and ensuring a more stable supply of this essential medicine.
Dispensed TRx: US Pharmaceutical Industry
Dispensed TRx: Total US Industry, MAT, March 2017 Lupin is ranked 5th in the US industry standings of all pharmaceuticals
As we move into FY 2018 and beyond, the Company endeavors to strengthen its portfolio with the launch of additional products developed and filed with the US FDA from its own pipeline as well as strategic brand acquisitions for the future.
Lupin’s India business has demonstrated robust growth in the current fiscal, featuring as the fastest growing player in the Indian Pharmaceutical Market (IPM). This is quite a commendable feat given the backdrop of a tough business environment, regulatory challenges coupled with frequent changes in drug prices by the National Pharmaceutical Pricing Authority (NPPA), impact of demonetization in the market and an increase in competition.
During the year ended March 2017, Lupin’s India Formulations Revenues reached ₹ 38,157 million, representing growth of 11% over the previous year and 15% CAGR over five-year period. With 3.3% market share, Lupin is the 6th largest player in the Indian Pharmaceutical Market (IPM).
The Company’s Top 5 therapies constitute more than 70% of the business in revenue terms. The endeavour has been to consolidate leadership in existing therapy areas by introducing novel molecules in the marketplace. We continue to strengthen our business by building new and fast growing therapeutic areas such as Gynaecology, Dermatology, Urology and Oncology, which will bolster our growth prospects for future
We improved our ranking by two places and are currently the 6th largest player in the IPM. We have sustained our position in the Anti-TB and Cardiology therapy, where we are ranked No. 1 and No. 2 respectively. We also improved our ranking in Respiratory, Anti-Diabetic and Anti-Infective therapy area. We registered particularly strong growth in Respiratory, Anti-Diabetic, Gastro-Intestinal and Gynaecology therapeutic areas and improved upon our market share during the year.
Domestic Market – LUPIN’s THERAPY
Lupin is well positioned to maintain its leadership in new product introductions with the goal to consolidate and improve its market share across segments. The success in the domestic market is an outcome of the dedication and expertise of our team of over 6,600 front line staff who remain committed to growth through strong customer engagement.
As we embark on our journey next year, we are conscious of the challenges that lie ahead of us. With the imminent launch of GST by the Government of India, the industry dynamics are likely to be impacted resulting in a short term disruption. We expect this to stabilize in the medium term and prove beneficial to the industry over the long term.
We are well prepared to address the challenges posed by this structural change and are gearing up to ensure minimal disruption to our supply chain.
The Company launched the ‘Softovac’ brand under its OTC division in select regions in the second half of FY 2017 and has plans to execute the pan-India launch next fiscal year to start our journey in OTC business.
ASIA PACIFIC (APAC)
The APAC region is home to one of Lupin’s largest markets, Japan. Valued at USD 352 billion, the region accounted for 20% of the global pharmaceutical market. Pharmaceutical sales in the APAC region have risen by 4.3% (constant currency) in 2016 (IMS) and the region is likely to remain one of the fastest growing in terms of healthcare spends. While aging population and concomitant spend on geriatric care, cost pressure particularly affect Japan, other markets are impacted by factors such as rising prevalence of chronic diseases, rapid urbanization, changing lifestyles. This adds to the complexity and intensity of medical needs in the market. Additionally, government initiatives to promote awareness of medicines, improve healthcare access and availability are catalysing pharmaceutical growth in the region.
Lupin’s APAC region revenues grew by 28% during FY 2017. We have built on our leadership credentials in Japan whilst consolidating on our gains in pharma markets in Philippines, Australia and South-East Asia. The Company made inroads into new markets like Vietnam, Myanmar, Malaysia and Taiwan whilst continuing to keep an eye on newer markets to assess further growth opportunities.
Japan is the 3rd largest pharmaceutical market in the world with total sales of approximately USD 80 billion (IMS World Review 2017). According to IMS MIDAS (MAT December 2016), generic segment sales have grown 7.6% in value (constant currency exchange rate) and 13.6% in volume following the government’s strong promotion of generic use to achieve the 80% generic substitution rate by 2020.
Japan is Lupin’s 3rd largest market and contributed 10% to our global revenues during FY 2017. It is also the largest market within the APAC region, representing 79% of the region’s total revenues. Lupin’s subsidiaries in Japan, Kyowa and Kyowa Criticare (collectively Kyowa) generated JPY 28,756 million (` 17,812 million) in revenues reflecting a healthy 15% increase over the previous year.
Kyowa is the 6th largest generic player in Japan and has a strong presence in Neurology and Psychiatry where key products are promoted under the AMEL brand.
During the year, the Company acquired 21 brands from Shionogi which helped to consolidate itself as a major player in the CNS space. Kyowa also entered into an agreement with Astellas to secure the exclusive rights to distribute and promote a new brand – Bipresso XR (extended-release tablets of quetiapine fumarate), prescribed for depressive symptoms associated with bipolar disorder as a CNS specialty product. During the year, the Company introduced 8 new generics (38 SKUs) and 4 neuro-psychiatric products in the market.
In order to address growing demand, the Company expanded its manufacturing operations by commissioning a greenfield facility in Totorri. The Company’s strategy to optimize cost by backending production at its dedicated off-shore facility in Goa gathered momentum during the course of the year with a significant increase in volumes and number of products. Kyowa’s Research Centre at Osaka duly supported by Lupin’s R&D capabilities worldwide are well geared to capitalize on upcoming patent expiration opportunities in Japan. This would help fulfil Kyowa’s goal to become a significant player in the Japanese generic market with meaningful new launches across therapy areas.
The Philippines pharmaceutical market scaled USD 3.5 billion in 2016, growing 5.5% in constant currency terms. The Company’s subsidiary in the Philippines, Multicare Pharmaceuticals Philippines Inc. (Multicare) is ranked 21st and is the fastest growing generic company in the country. Multicare is a premium branded generics company which improved its position to Rank No. 5 among its peers (branded generic), and ranked 18th among the leading pharmaceutical companies in the country with a strong presence in Diabetes, Women’s Health, Pediatrics, Respiratory, Central Nervous System and Oncology.
The Company had a strong year with revenues of PHP 1,969 million (` 2,741 million) growing at 23% compared to the previous year.
The Australian pharmaceutical market is valued at USD 13 billion. Generics constitute more than 30% of the pharmaceutical sales volume in the region. The Company’s Australian subsidiary, Generic Health generated revenues of AUD 34 million (₹ 1,713 million) and reported a growth of 17%. This performance helped the Company surpass market growth rate significantly. Generic Health is a supplier of generic Rx and OTC to pharmacies in Australia. It is the 7th largest company and also 4th fastest growing company in the generic segment in the country.
Europe, Middle-East & Africa
SETTING THE PACE
Lupin’s EMEA business headquartered in Zug, Switzerland includes Europe, Middle-East, Asia and Africa. Lupin EMEA registered revenues of ₹ 10,115 million in FY 2017, accounting for 6% of the Company’s global revenues. Lupin’s strategy is centred building a meaningful presence in the Top 5 European markets with a robust portfolio of niche products and meaningful forays in the specialty space. In addition, the Company is gearing to scale up its presence in emerging markets of South Africa, Russia and other allied markets.
Building on our growth momentum, Lupin’s Europe revenues grew 11%, registering sales of ₹ 4,507 million. In line with its strategy of building a Specialty products portfolio while nurturing its Generics business in the region, the Company is exploring possibilities of additions to its existing portfolio acquired from Temmler Pharma GmbH & Co. in FY 2016. This includes Specialty products for an orphan indication which can be commercialised across Top 5 European markets. Lupin’s partnered business in Europe continued to perform strongly during FY 2017 on the back of niche product launches in the ARV segment.
Lupin’s German subsidiary Hormosan, with a balanced mix of Generics and Specialty products, particularly focussing on Neurology, achieved a strong sales growth of 25% in FY 2017.
The Company filed three marketing authorization applications with European authorities in addition to getting six approvals during the year. Currently, the cumulative filings for Europe stand at 62 with 55 approvals received till date.
The South African pharmaceutical market, with a current market size of USD 2.7 billion is growing at 6.4% in value and 1.6% in volume terms. In FY 2017, Lupin’s South African subsidiary Pharma Dynamics (PD) achieved the milestone of scaling ZAR 1 billion (₹ 4,816 million) in revenues for the first time since its inception with a growth of 21% over the previous fiscal in constant currency terms.
PD ranks among the top 20 pharmaceutical companies in South Africa and is currently the 4th largest generics player as well as the 3rd largest generic company by prescriptions in the country (IMS Health, March 2017). PD is the market leader in the cardiovascular space with sales of ZAR 530 million.
LATIN AMERICA (LATAM)
SPREADING OUR WINGS
As part of its strategic vision, Lupin identified growth opportunities in Latin America and presence in two of the largest markets in the region – Brazil and Mexico. It has been two years since Lupin entered the region through acquisitions of Medquímica Industria Farmaceutica LTDA (Medquimica) in Brazil and Laboratorios Grin S.A. DE C.V. (Grin) in Mexico. The region registered good growth in FY 2017 despite currency devaluations impacting both the Brazilian Real and the Mexican Peso over the last 12 months. Currently, the focus lies on expanding our product portfolio, enhancing footprint and deepening relationship with existing partners. By achieving this, we expect to increase sales and claim a greater share of the Latin American market.
Brazil stands out as a major market for pharmaceuticals in Latin America and accounts for over 35% of the regional sales, ranked as the 6th largest pharmaceutical market in the world. It is valued at USD 23 billion with potential to sustain low double digit growth over the next 5 years. Lupin’s Brazilian subsidiary, Medquimica has gained a reputation as one of Brazil’s fastest growing branded generic companies with a growth of 53% for FY 2017 and sales of BRL 126 million. It improved its ranking by three positions, featuring amongst the Top 15 companies in terms of volumes. It would be our endeavor to expand and strengthen our branded generics portfolio through the organic route complemented by strategic alliances. Apart from this,we will expand our portfolio in niche therapies like Ophthalmology, Respiratory and Dermatology resulting in steady pace of new product launches over the next few years.
Mexico is the world’s 11th largest and LATAM’s 2nd largest pharmaceutical market sizing up to USD 14.5 billion. Grin, Lupin’s subsidiary in Mexico has over its five decades of existence emerged as a specialty pharmaceutical company developing and manufacturing branded ophthalmic products. The Company continues to outshine competition and the industry in the represented segments. Grin reported revenues of MXP 530 million in FY 2017 on the back of a healthy number of product approvals. Today, Grin holds the 4th position amongst the ophthalmic players in Mexico as it looks to build on its strength and gradually expand its therapeutic presence into other areas such as Respiratory, etc.
Global Active Pharmaceutical Ingredients includes Lupin’s Active Pharmaceutical Ingredients (API) peer to peer business as well as the Global Institutional Business (GIB). API are the principal ingredients for pharmaceutical finished products. Over the last three decades, India has established itself as one of the most preferred manufacturer and supplier of API globally, in particular to the US and Europe. FY 2017 saw the Company’s API output significantly increase in volume as well as value with revenues of ₹ 11,383 million accounting for 7% of the Company’s overall revenues.
While India itself is a large market, the Indian API industry is primarily export-driven and the past few years have seen it shift in favor of regulated markets. Outside the US, India holds the proud distinction as the world’s leader in Drug Master Files (DMF) applications.
With a legacy spanning four decades, Lupin is one of the few global Pharmaceutical companies with a meaningful API business. We remain one of the most vertically integrated companies with a sharp focus on building efficiencies in manufacturing quality APIs and achieving significant global scale. Strengthening the product portfolio, ensuring new customer lock-ins in Advanced Markets like US, Europe and Japan and cementing newer partnerships in emerging markets like China, Brazil, Mexico, Korea and Russia have been some of the key highlights of FY 2017.
We are consciously investing in adopting green chemistry and enzymatic technologies with a dual purpose of improving efficiencies and protecting the environment. Fermentation technology based products have been Lupin’s specialty expertise and we are on track to introduce newer products in this field.
The GIB business continues to maintain its prestigious position as one of the few coveted suppliers of Anti-TB products to WHO’s Global Drug facility with the highest market share. Our supplies have contributed largely to India’s Tuberculosis (TB) eradication program as envisioned by the Government of India. Lupin is also the sole Company to have both its API and formulations for TB products pre-qualified by the WHO globally.
TB remains one of the largest menaces faced by mankind and Lupin is at the forefront to combat and eradicate this menace. We are currently developing a range of second line Anti-TB drugs for global supply and also closely working with global health authorities to fight the deadly effects of the disease. Apart from this, we are also developing a variety of children-friendly Anti-TB formulations which would help treat young patients so they can live a healthier, happier life.
RESEARCH & DEVELOPMENT
POWERING THE FUTURE
Technological progress and scientific advancements continue to transform lives and disrupt businesses. Additionally, pharmaceutical business paradigms are also being impacted by factors beyond the conventional forces such as aging populations, spiraling healthcare costs, increase in chronic diseases or change in disease patterns. The industry needs to embrace new advances in digital technology, communications, systems and software. The global pharmaceutical industry is on the cusp of an era of significant transformation. The world of life sciences is converging like never before and the convergence of pharmaceutical, biotechnology and medical technology would improve outcomes that could dramatically alter drug development and delivery.
Lupin’s investments in Research and Development (R&D) have helped us gain a leadership position in differentiated product introductions and become a formidable player in the generics space. It forms the base for further successes as we emerge gradually as a specialty pharmaceutical player. These investments are calibrated for risks and appropriate returns and encompass not merely the developed markets like US, Europe and Japan but also the emerging markets.
With a solid team of 1,700 scientists and technologists employed at our state-of-the art facilities in India and abroad, we are well on track to emerge as an innovation led transnational pharmaceutical powerhouse providing affordable healthcare solutions with uncompromising quality. Lupin’s research scientists have a proven track record of delivering high quality technology intensive products, Active Pharmaceutical Ingredients (APIs), Formulations and newer dispensation forms.
In keeping with our focus on research led financial growth, we have increased investments in Research & Development in the current fiscal to ₹ 23,101 million, which is 13.5% of our global revenues. This continues to drive our efforts in finding novel solutions and ramp up efforts on a range of delivery systems spanning multiple concepts and solutions.
The scientists work closely with the respective business teams to generate innovative concepts and ideas, exploiting both the unmet market and synergies across therapeutic areas. We focus on areas like complex generics, Novel Drug Discovery and Development (NDDD) and Biotechnology.
Novel Drug Discovery & Development (NDDD)
The NDDD team has developed a pipeline of 11 highly differentiated and innovative new chemical entities in focused therapy areas of CNS disorders, Oncology, Immunology, Pain and Metabolic disorders.
Key Targets & Status:
Clinical Phase-I study successfully completed in Europe and two Phase-II studies in Europe are ongoing (Rheumatoid Arthritis and Psoriasis). The targets have the potential to be first-in-class in chosen therapy area.
Clinical Phase-I study successfully completed in Europe and has met the approvable primary end-point. Results for Phase-II will soon be ready and further studies will be conducted in India.
Clinical Phase-I study has been successfully completed in Europe on terminally-ill patients (Lung Cancer, Melanoma & Colon Cancer). Phase-II study will soon commence in India for treating refractory type of Lung cancer.
Biotechnology Development Program
Based out of Pune, Lupin Biotech, our world-class R&D centre was founded in 2008 with advanced capabilities in areas like development, manufacturing and pre-clinical studies to clinical programs in biotechnology products required for approval in both regulated and semi-regulated markets.
The developmental pipeline includes a mix of blockbuster products of both microbial and mammalian origin, across diverse indications such as rheumatoid arthritis, ophthalmology, oncology and osteoporosis indications.
Highlights – FY 2017
• Construction and commissioning of state-of-the-art fill-finish facility within the Biotech premises
• The first two oncology products commercialized in India: Lupifil® and Lupifil-P® (biosimilars for the molecules Filgrastim and Peg-Filgrastim) are steadily gaining traction in the Indian market since its launch in May 2015. Preparations are underway to seek approval and register these products across global markets
• Biosimilar for Etanercept (brand Enbrel) is being developed currently with YL Biologics (the joint venture of Lupin and Yoshindo, Japan) and the global Phase-III clinical trials are nearing completion. Our global trials for biosimilar Etanercept were conducted across Japan, India and markets of Europe on over 500 patients
The coming year has exciting milestones to look forward to, especially with MAA filings slated in Japan and Europe. The manufacturing facility is also gearing up for audits by respective regulatory agencies and paving a path for swift commercialization of the product.
Comprehensive regulatory strategies are being devised to optimize the development timelines. Clinical trial initiation for two more priority projects are planned in the upcoming year, in addition to the ongoing trials for Etanercept.
The pipeline is well positioned to ride the wave of upcoming biosimilars in the short and long term respectively. High throughput methods, automation and future technologies are being put to test for the development and selection of high-yielding Biosimilar clones.
The Company’s efforts during the year resulted in it filing 3 National Phase patents in the global markets accompanied by 2 provisional patents and 1 PCT application.
Lupin Biotech plans to progress across markets with international partners possessing complementary capabilities in product development, IP generation and commercialization. This would help to mitigate risk and achieve higher execution success. The Company hopes to realize our ambition of positioning Lupin Biotech as a global player navigating complex regulatory, IP and socio-economic framework.
Generic Pharmaceutical and API Research
Yet again, Lupin’s Generic Pharmaceutical Research team has demonstrated a stellar performance with a record number of ANDA filings in US and other advanced markets from its global R&D hub in Pune, India. With the commissioning of the new R&D building at Pune, India, Lupin can now boast of one of the most advanced pharmaceutical product development & pilot plant facilities for oral, ophthalmic, dermatology and inhalation product development. This facility will be leading future innovations aimed at creating a highly differentiated global pipeline of complex generics.
The Company’s generic pipeline is focused on identifying and developing high entry barrier products with complexities linked with delivery system, device compatibility and clinical trial requirement. Simultaneously, we continue to bolster our oral solids pipeline in view of upcoming patent expiration as well as market needs thereby providing a balanced mix to the pipeline.
The formulations research is supported by API Process Research Group. This includes 150 scientists assisted by equal number of analytical chemists who specialize in the development of processes for the manufacturing of APIs including intermediates, key starting material, chemicals and biological (fermentation).
Lupin’s process research consists of chemical technologies, including chemical synthesis, semi-synthetic fermentation, enzymatic synthesis and high potent API development. Furthermore, it also champions the advanced research in solid-state particle technology and polymorphism.
Highlights – FY 2017
• Filed 37 ANDAs & 1 NDA (31 oral, 5 dermatology, 1 ophthalmic & 1 metered dose inhaler), including 3 confirmed FTF and 4 potential FTF products with the US FDA. Lupin received 34 ANDA approvals from US FDA during FY 2017. Cumulative ANDA filings with the US FDA now stand at 368 with 214 approvals received to date. Lupin now has total of 45 FTF ANDAs which includes 23 exclusive FTF opportunities
• Filed 23 generic products in other advanced markets including EMEA (Europe, South Africa & Russia), APAC (Japan & Australia), Canada, Latin America & Mexico and also received 16 approvals in these markets
• Filed 15 DMFs, taking the cumulative filings to 187. Additionally, filed 3 PEPFAR DMFs and 2 CEP filings
Intellectual Property Management Group (IPMG)
Lupin’s IPMG has been responsible for creating, cultivating, leveraging and securing an ever growing portfolio of high-value patents, product and research pipeline. Its IPMG has been carrying out patent litigations and challenges successfully.
The Company was first-to-file with respect to the generic versions of Belviq® tablets, Myrbetriq® extended release tablets and Eliquis® tablets. Lupin’s confirmed first-to-file products tally of 45 remains impressive. We successfully launched the generic versions of the following products with first-to-file exclusivity – Minastrin® 24 Fe (Ethinyl Estradiol; Norethindrone acetate, 0.02mg; 1mg, Chewable Tablets), Quartette® (Ethinyl Estradiol; Levonorgestrel, 0.02mg, 0.15mg; 0.025mg, 0.15mg; 0.03mg, 0.15mg; 0.01mg, N/A, Tablets) and Pristiq® (Desvenlafaxine 50mg and 100mg ER Tablets).
In addition, the Company settled twelve pending patent litigations during the fiscal and received favorable decisions on Axiron®, Effient® and Abilify®.
In FY 2017, our research led patent filing grew strong as we filed for 312 applications. Since its inception, Lupin has filed 2,837 patents across a wide global network. The patent applications filed during FY 2017 includes 39 formulation patent applications, 128 API/process patent applications in addition to 42 biotech patent applications and 103 NDDD patent applications. We successfully secured 72 patents including 3 formulation patents, 3 API patents and 66 NDDD patents.
Lupin Bioresearch Centre
The Lupin Bioresearch Centre (LBC) located in Pune, India has continuously maintained its stellar performance on the regulatory compliance front with successful UK MHRA, US FDA, DCGI and NABL inspections in FY 2017 for conducting bioequivalence studies for Lupin’s generic products and branded formulations. LBC has also managed Lupin’s outsourced bioequivalence studies including project management.
LBC has both clinical and bioanalytical capabilities – 2 in-house clinics and bioanalytical labs equipped with 14 high-end LC-MS/MS systems, 2 Ion Chromatography (IC) systems, 1 MSD / ELISA systems for PK/PD and Immunogenicity studies of Biosimilar products. LBC supports global clinical projects for Lupin’s R&D verticals in India, Japan and US. In FY 2017, LBC established the in-vitro BE laboratory to conduct regulatory studies for Lupin’s respiratory product development program and also established efficient Biometrics department for its ANDA program. LBC completed 42 full studies during FY 2017 at its site, taking the cumulative tally to 267 studies and established about 200 validated analytical methods till date.
Global Manufacturing & Supply Chain
Lupin takes pride in its quality-led manufacturing base that keeps the customer at the centre of its business philosophy. A global network of state-of-the-art manufacturing facilities has helped us build scale and enabled us to meet customer needs. Our ability to lead as a global formulations and API powerhouse is an outcome of our unrelenting focus on operational excellence and quality programs. The philosophy is simple – drive continuous improvement and innovation, facilitate teamwork, eliminate efficiencies and encourage lean manufacturing. We are bound by this philosophy across all our 18 manufacturing facilities in India, United States, Japan, Brazil and Mexico.
As per global manufacturing norms, all pharmaceutical facilities are periodically inspected and audited by regulatory authorities like the US FDA, World Health Organization (WHO), MHRA (UK), TGA (Australia), MHLW (Japan), ANVISA (Brazil) and MCC (South Africa), among others. Lupin’s manufacturing facilities are also inspected as a standard practice. Our operations, supply chain and procurement processes are aligned to global commercial plan and protocols. This helps to ensure smooth transfer of inputs into our plants and timely output of products to world-wide customers. Our Global supply chain has been instrumental in making us the preferred suppliers amongst customers. The key metrics of deliverance like OTIF (On Time in Full) has remained above 95% in majority of the markets. This has enabled improvement in metrics like ‘Forecast Accuracy’, ‘Requirement Vs Commitment’ and ‘Adherence to Plan’ in the current financial year. We value our customers deeply and have placed stringent procurement processes in order to be competitive and serve them on-time. In order to minimize supply dependency, de-risking projects are routinely undertaken for seamless supply and cost optimization.
Highlights – FY 2017
• Successfully cleared the US FDA inspection at Dabhasa, Indore, Nagpur and Mandideep facilities as well as at the Lupin Bioresearch Centre in Pune during the year
• Successful inspections by other regulators such as MHRA (UK), ANVISA (Brazil), PMDA (Japan) and WHO during the year
• Quality transformation project was undertaken in collaboration with PricewaterhouseCoopers (PwC) at Tarapur and Goa plant. The learnings from this project are being extended to the other manufacturing facilities as well
• New formulations facility at Sikkim commenced commercial production to support the growing market in India. We also expanded our fermentation capacity at Tarapur to support new products – Capreomycin & Kanamycin into our Global Institutional Business portfolio and commissioned pilot Biotech fill-finish dosage formulations facility in Pune
• Investing in a new sterile formulations facility at Nagpur, a new Oncology API manufacturing facility at Vishakhapatnam and expanding our OSD facilities at Nagpur & Indore
• Expansion of our manufacturing footprint overseas by setting up a green-field Oral Solid Dosage (OSD) facility at Tottori, Japan and expansion of manufacturing capacity at its formulations facility in Somerset, US These investments were made to create sufficient capacities to support future business growth and build new capabilities for complex and specialty generics. ‘DISHA’ – the Company’s initiative for operational excellence completed 5 years. Key highlights:
• Currently 100+ operational excellence projects are in progress
• Lupin retained the prestigious QCI-DL Shah National Award for operational excellence for the 3rd consecutive time. We also bagged the 10th Lean Six Sigma National Level Competition organized by CII
• Lupin continues to live up to high standards set by other global giants like McKinsey & Company on productivity (POBOS- Pharma Operations Benchmarking of Solids)
• Capability development has always been a key area of focus for ‘DISHA’ – the Company’s initiative for operational excellence. As a result, more than 2,000 Lupinytts have undergone training for Lean, Six Sigma, TPM, MOST and ERR
COLLABORATING FOR SUCCESS
At Lupin our endeavor is to create a harmonious and inclusive environment where our people can realize their full potential. Our ambitious strategy of growth in developed and emerging markets need a workforce of talented and motivated individuals who can adopt the Company’s “One Lupin” culture.
Our value-driven culture rooted in innovation and operational excellence offers a great environment to realise professional aspirations. Our highly motivated and experienced team are a competitive advantage. As a testament of our progressive people-centric HR practices, Lupin is featured in the List of Top Employers categorized as ‘Great Places to Work – 2017’. Lupin is recognized in the top 15 Great places to work in Asia 2015 and Aon best employers of India 2016. This recognition is a reflection of the trust our employees have in the Company and is due to the solid foundation of credibility, respect, fairness, pride and camaraderie.
Our organization is built around the “Spirit of Lupin” – a pledge of unyielding integrity, passion for excellence, teamwork, entrepreneurial spirit, respect & care and customer focus as the foundational values that shape our culture. The vision of HR is to guide our people initiatives to “Enable, Build and Grow” talent across the organization to meet business aspirations.
We believe that People play a pivotal role in contributing to organization’s growth and success and are therefore indispensable to the success of our organization. We aim to achieve success through the policies and nurture people skills and capabilities through best-in-class training.
We believe that every Lupinytt is a Partner with us in our journey to Progress. The Partners in Progress – an Employee Stock Option program is performance lead without being driven by organizational hierarchy. This gives every employee, a chance to participate in the growth story of the Company by directly contributing to and reaping the sweet rewards of success.
Being a global company, we strive to create an open mindset to build a common pool of highly skilled executives and professionals. Our endeavor is to develop an integrated system oriented towards institutionalized development of talent management process and offer the resources and training interventions to prepare our teams to win in the market.
Corporate Social Obligation
Decades before Corporate Social Responsibility (CSR) became mandatory, we were amongst the first corporates to take concrete steps towards ensuring that the benefits of economic progress and of scientific and social development reach rural India. The Lupin Human Welfare & Research Foundation (LHWRF) was founded in 1988.
We aim to transform rural India by creating sustainable and replicable programs around economic, social and infrastructure development targeted at uplifting the poorest of the poor residing in remote villages of India. Our Founder & Chairman, Dr. Desh Bandhu Gupta has always believed that an individual is indebted to Society for his or her growth. It was this guiding inner voice that led to the formation of LHWRF. We have chosen to work in the poorest of villages, in the most dire circumstances – and our activities have been backed by human development indicators. Over the years, we have expanded our outreach and added scale to ensure growth and progress for rural communities across the country. The Foundation reaches out to 2.8 million people, living in over 3,463 villages located in 59 blocks, spread across 8 states in India. We operate through 18 hubs in Rajasthan (Alwar, Dholpur and Bharatpur), Maharashtra (Nagpur, Tarapur, Aurangabad, Dhule, Nandurbar, Pune and Sindhudurg), Madhya Pradesh (Bhopal and Dhar), Uttarakhand (Rishikesh), Goa (Dhargal), Gujarat (Dabhasa and Ankleshwar), Jammu and Kashmir (Jammu) and Andhra Pradesh (Vizag).
• Agriculture development
• Promoting livestock development
• Skill development
• Rural Industries promotion
• Women empowerment
• Providing Quality Health Services in remote areas
• Innovative Education interventions
• Infrastructure development and Natural Resource Management
CFO & Executive Director’s Letter – Financial Review
Business Performance & Balance Sheet Highlights
Lupin maintained its upward growth momentum amidst very challenging and dynamic global economic conditions in the year gone by. The Company ended the fiscal on a high note registering significant growth across our key markets. Lupin remains committed to delivering and enhancing shareholder value which is reflected in an increase in market capitalization by over thirteen times in the last decade.
• The Company recorded consolidated sales of ₹ 171,198 million in FY 2017, a growth of 24% over FY 2016
• Earnings before Interest, Tax, Depreciation and Amortization (EBITDA) increased by 19% to ₹ 45,997 million as compared to ₹ 38,705 million in FY 2016
• Profit before tax (PBT) increased by 6% to ₹ 35,349 million as compared to ₹ 33,239 million in FY 2016
• Net profit increased by 13% to ₹ 25,575 million as compared to ₹ 22,607 million in FY 2016
• Our Reserves & Surplus increased to ₹ 134,976 million during FY 2017 • Net Debt-Equity ratio for the Company stands at 0.38:1
Earnings per Share, Dividend & Taxation
The Company recorded Earnings per Share (EPS) of ₹ 56.69 during FY 2017. Lupin’s Board of Directors proposed a dividend of 375%. The Company’s effective tax rate for FY 2017 was 27.6% as compared 31.8% during FY 2016.
Investing for Future
Mergers & Acquisitions (M&A)
The inorganic expansion for the Company which was strategically focused on geographical expansion in order to leverage a robust generic portfolio is now aligned towards Specialty areas and niche technological platforms in the developed markets. Much of Lupin’s M&A activity in FY 2017 was focused on strengthening our positioning in Japan. In this direction, Lupin acquired a portfolio of 21 long-listed products from Shionogi & Co., Ltd. (Japan). The acquired portfolio covers therapy areas such as Central Nervous System (CNS), Oncology, Cardiovascular and Anti-Infectives. These 21 products generated sales of JPY 9,400 million (USD 90 million) collectively on NHI price basis. Consequently, Kyowa’s rank improved to 6th amongst generic companies in Japan.
Lupin also acquired exclusive rights to distribute and promote extended-release tablets of quetiapine fumarate in Japan under the brand name Bipresso XR.
Keeping the long term vision and cost competitiveness in mind, the Company continues to invest in creating new manufacturing facilities as well as augmenting existing manufacturing facilities globally to aid efficiencies as well as build capacities to meet the future demand. It also remains committed to investing in technology, automation and safe-guarding intellectual property. The Company invested ₹ 16,634 million for capital investment during FY 2017.
Research & Development (R&D)
Lupin has been at the forefront of investing in R&D ahead of the curve to operationalize its vision to become an innovation driven pharmaceutical company. During FY 2017, the Company invested ₹ 23,101 million, 13.5% of sales. The Company filed its first ever Inhalation product for the US market during the year. We also made significant progress on the biosimilar front. We are investing to create a differentiated pipeline of complex generics, biosimilars and NDDD.
Internal Control Systems &
Information Technology (IT)
The Company continues to calibrate and update its business process and operations framework to continuously improve efficiencies. These include automated internal business workflow and controls which integrate key functions such as research, technical operations, manufacturing, supply chain, integrating them with key support functions like marketing, sales, finance, regulatory affairs and HR. A well-established and empowered system of internal audits and automated control procedures ensures discipline and compliance. All of this backed up by a strong internal audit framework which monitors and controls all systems and processes and business groups ensuring compliance to financial norms and procedures, building financial control, accountability and integrity within our business ecosystem. We are ably assisted by Ernst and Young who are our internal auditors.
Risks, Concerns & Threat
The year witnessed significant volatility in global commodity price and foreign currencies throughout the year. This was further accentuated by political change in our largest market, the United States and concomitant increased scrutiny over drug pricing. Disruption in the domestic market continued in the form of demonetisation, curbs on fixed dose combinations and unabated expansion of the span of price controls. A formidable financial organization built over the last decade has helped us address the challenging business environment. Bound by a strong compliance ethic, we rely heavily on risk
management and forecasting frameworks to manage competitive, economic, financial, geo-political and social risks.
The Company’s hedging strategy for the short, mid and the long-term through forward exchange contracts helped minimize FOREX volatility risk. The continued investments in creating a global supply chain leveraging real time business intelligence, reporting and forecasting systems has helped ensure business continuity and sustain growth to deliver value.
The Company continues to navigate challenges within the Industry successfully be it price cuts or increased price controls, customer consolidation or increased competition. The Company’s global supply chain, its efforts toward continuously de-risking global procurement, the ability to increase market shares in key markets and the ability to service key customers globally has enabled it to consolidate and build on the leadership credentials and maintain growth momentum.
A Global Pharmaceutical Powerhouse
USD >2.5 BILLION
Our Drugs reach
>100 countries across the world
Quality Manufacturing & Compliance:
12 sites in India; 3 in Japan; 1 in US;
2 in LATAM
2 sites in US; 2 in India; 2 in Japan;
2 in LATAM; 1 in Europe
Marketing & Corporate Development:
Over 25 offices across the globe
This report contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this report.