Vivimed Labs Limited Annual Report 2018-19 Contents
Corporate Overview 1 Committed to perform 6 Statement from the Managing Director 10 About Vivimed 12 About the business 16 2018-19 in a nutshell 17 Financial progress
Statutory Reports 18 Management Discussion and Analysis 32 Corporate information 33 Board’s Report 71 Corporate Governance Report
Financial Statements 99 Standalone Financial Statements 144 Consolidated Financial Statements
Agenda to AGM 187 Notice There are generally two categories of companies in the world. First are the ones who’re knocked down and resign to that fate. The second are those who get back up, repeatedly, despite everything. In other words, the ones who’re committed to perform. Just like us. Annual Report 2018-19 1 Our journey this far has been adventurous at best, each year being more challenging than the previous.
We struggled. We braved. We battled. But, through it all, we also found the will power to rewrite strategies that could make a difference in the long run. We invested our time and focus into making necessary adjustments and changes to strengthen our position, which would help in sustaining our successes. VIVIMED LABS LIMITED 2 In other words, we remained committed to perform, without once giving up on the future we’ve always had in our Annual Report 2018-19 mind! 3 Committed to perform Evolving to the next
Having established our It builds our technology tool box. credentials with global Vivimed can leverage Soneas’ pharmaceutical majors as a high level of competency in reliable supplier of quality APIs, emerging technologies such as we now focused on transitioning metal catalysis and heterocyclic to a higher level – from a supplier chemistry. This acquisition to a developing partner. It broadens our market offering positions This evolution was critical for in the CDMO space. us as it promised to cement a Vivimed as Vivimed can undertake preclinical, lasting bond with our customers. phase I, II and III NCE project an end-to- It provided revenue visibility. It development. end solutions added immense value to our provider in the API business. It made business It adds to our end-usage growth increasingly sustainable. capabilities. global API-CDMO In keeping with this belief, we Vivimed can leverage Soneas’ business. acquired the Hungary-based diverse end-usage capabilities CDMO company, Soneas, in May in neurology, dermatology, VIVIMED LABS LIMITED 2018. This is what it does for us. metathesis catalysts and synthetic hormones. 4 We are establishing a flanking business vertical – asset-light model It enhances our regulated markets namely the Idea is to create a brand manufacturing footprint. US, Europe and Japan. that is a store house of IP Soneas brings with it a cGMP assets using our extensive It increases our customer pilot plant and over 180KL knowledge pool in pharma base. industry - formulations of key starting material that will allow us to (KSM) cGMP capacities to the SONEAS enjoys multi-year relationships with innovator explore new geographies, assetblock. breakthrough in complex companies based in Japan and molecules and also new It allows us to utilise our Europe. dosage forms capacities better. It contributes to our A model in which the Company collaborates Soneas can potentially feed financials right away. with strategic partners into UQUIFA´s existing Soneas has a pipeline of who develop the manufacturing facilities in Spain multiple projects where it is formulations and/or and Mexico. collaborating with customers in manufacture and market Phase 2 and Phase 3 of a new the products in regulated It widens our geographic markets; Vivimed earns drug development. presence. revenue from a profit- sharing model and co-
SONEAS has a significant Annual Report 2018-19 owns the IP asset.. presence in important 5
Statement from the Managing Director “My singular message to my shareholders is that I remain committed to grow this business. Because when commitment to grow is at the heart of any journey, success is a natural corollary.”
Dear shareholders, Vivimed, through UQUIFA, has reach US$116.2 Bn by 2026. established its presence in the Fiscal 2018-19 was an To capitalise effectively of the global CDMO space having important milestone in our growing market opportunities, successfully delivered projects journey from a strategic we needed to widen our to global pharmaceutical perspective. We achieved some technology pool, expand our players. The CDMO business important successes which capability matrix and our grew exponentially over the showcase our commitment to service offering across product last five years. – from <5% of grow our organisation amidst development value chain. This UQUIFAs business in 2012 to economic headwinds and is where Soneas appears as ~25% in 2017. sectoral challenges. Because a best fit to our API business when commitment to growth Interestingly, CDMO business spearheaded by UQUIFA. is at the heart of any journey, opportunities are increasing Hence, Soneas, I am confident, success is a natural corollary. as global players are focused will add considerable value on optimising costs in keeping Our defining step was the to UQUIFA’s operating model. with the clarion call across the acquisition of Soneas, a Moreover, it will bring to global of reducing healthcare dedicated CDMO player, at fruition Vivimed’s vision of costs. According to a report the start of fiscal 2018-19. making UQUIFA an integrated by Credence Research, CDMO is an interesting space global CDMO player and Inc.’ Pharmaceutical CDMO to be in owing to its inherent catapult the combined CDMO Services Market - Growth, characteristics such as piece into a new growth orbit. Future Prospects, Competitive customer stickiness, revenue Analysis, 2018-2026, the The other important move was visibility and superior margins. global Pharmaceutical CDMO the exit from the joint venture But it has its challenges too – Services Market was estimated with Strides Shasun in the extensive research expertise at US$65.6 Bn in 2017; it is Finished Dosage space. It was and a long gestation for Annual Report 2018-19 expected to expand at a CAGR a win-win for both partners. investments to transform into of 6.5% from 2018 to 2026, to For us, it released critical returns. 7 management bandwidth to Our API business is gaining returns in the next 12-18 sharpen our focus on certain healthy traction. I believe that months. markets of our choice. For with team’s efforts in seeding One of the most heartening Strides, it strengthened their multiple markets, we may soon facts is that we have replicated presence in the US market. be faced with a capacity shortfall the CDMO model in our Moreover, we utilised the funds for some of our key products. formulations space, but with received owing to the exit to We would need to debottleneck a difference. We call it the pare down our debt. our infrastructure to release Virtual Pharma segment. This capacity to accommodate Having said that, I must mention is an interesting concept. We additional volumes. that debt management has will create a pool of high value, been foremost on our minds. Our CDMO segment is also high risk molecules using are Between March 2017 and June picking up momentum with extensive knowledge in the 2018, we have reduced our a healthy uptick in orders in pharma industry. On successful debt burden from C1010 crore the first quarter of the current development, we will enter to C837 crore (includes C111 year (2019-20). I am hopeful of into a profit-sharing alliance crore added in 2018-19 owing to sustaining this momentum in with a large pharmaceutical the acquisition of Soneas). We the current year. majors for manufacturing will continue to focus on debt and marketing the product in reduction in the coming years. Our finished dosage business regulated markets of the US, should experience a healthy Europe and Canada. This asset- The road ahead uptick in volumes over starting light operating model would from the current year as the I am particularly optimistic open a new, profitable and team has worked tirelessly in about our prospects over the sustainable revenue stream for expanding their footprint in medium term. the Company. VIVIMED LABS LIMITED new markets. I feel these new markets would start delivering 8 In closing sincere gratitude to my fellow I feel we are well positioned Directors for their commitment on our performance journey. and professionalism in paving But I must admit that during the Company’s long-term path. this journey, there will be ups I would like to thank our and downs. We will be putting esteemed shareholders, ourselves in uncomfortable, partners and other challenging positions. But the stakeholders for believing in point is, regardless of outcome, our story and reposing their it’s the focus on each step and confidence in our capability and each moment of the learning extending their support in our that is critical. long journey of endurance.
Because, these learnings are And most importantly, I place the essentials we will need to on record my gratitude to our rely on to develop, progress management team and staff and perform. Because these for their valuable and ongoing learning will help us challenge dedication in contributing to status quo, push ourselves the Company’s growth outside our comfort zone and take on new challenges and opportunities with a vision of a Warm regards better tomorrow. Santosh Varalwar Acknowledgment
A fellow shareholder Annual Report 2018-19 As we move forward into 2019- 20, I would like to express my 9 About Vivimed Labs
A globally renowned partner that touches the lives of millions through its expertise in chemistry
Over nearly three on quality and compliance decades, Vivimed Labs has reflects in aligning its systems metamorphosed from a and processes with stringent domestic small, entrepreneurial global standard – three of its family-operated business to manufacturing facilities are US- a globally renowned supplier FDA approved; the Company has of niche molecules and also gained PIC/S GMP approval Three of formulations across Healthcare, for the supply of finished Vivimed’s Pharmaceuticals and Specialty pharmaceutical formulations. Chemicals consumers in nearly 50 manufacturing countries.
facilities Vivimed has, over its business are US- FDA journey, established, 12 manufacturing facilities, 6 R&D centres and global support
VIVIMED LABS LIMITED approved offices in India, China, Europe and USA. The Company’s focus 10 Our Presence
Shareholder information India Mexico (as on March 31, 2019)
Kashipur Haridwar Promoters’ stake: 34.39% Cuernavaca Market capitalisation: D1,931.05 million Kolkata Face value per share: D2/- Balarum Bidar Joodimetla (2 Unit) BSE Code: 532660 NSE Code: VIVIMED Spain Hungary Sant Calony Earnings per share: D6.67 (diluted) Llica Do Vall
Budapest
Our reputed global clientele
Our Values and Principles
WE FOCUS ON WE BUILD ON OUR WE EMBRACE CHANGE OPPORTUNITIES CAPABILITIES At Vivimed we consider the only At Vivimed we believe that Capability building is the key to constant to be, is change itself. there is no room for a second our Company’s performance chance. and growth. WE STRIVE FOR CONTINUOUS IMPROVEMENT An opportunity presents itself At both individual and There are others; and there only once, and we usually make organisational level, there is a is Vivimed. We strive for it ours. consistent effort to build up on continuous improvement in our Annual Report 2018-19 our competencies. quality standards, operational efficiency and customer service. 11 About our business
A corporate with three revenue streams VIVIMED LABS LIMITED 12 Active Pharmaceutical Ingredients
UQUIFA, an API franchisee of Headquartered in Barcelona, are Etofenamate, Doxylamine the Vivimed Group, is a leading with state-of-the-art production Succinate, Ranitidine, international supplier of active facilities spread across three Omeprazole, Pantoprazole and pharmaceutical ingredients continents. The Company Quetiapine. (APIs) and intermediates to enjoys a strong market share the Pharmaceutical Industry. some niche molecules which
4 3 70 Manufacturing facilities R&D facilities Global footprint (nations)
150+ 20+ 73 Active DMF’s Approved COS Contribution to revenue (%) Annual Report 2018-19 13 2 Finished Dosage Forms
Vivimed manufactures niche Proprietary products formulations based on multiple Branded – marketed in India delivery platforms at its two manufacturing sites which are Generic - find acceptance widely accepted in pharmerging in India and in multiple markets across the globe. pharmerging markets across Within this vertical the the globe Company has two segments: Custom manufacturing for large formulators in India
6 1 50+ 15 Manufacturing R&D facilities Customers Contribution to facilities revenue (%) VIVIMED LABS LIMITED 14 3 Specialty Chemicals
The Company is a global (Bidar-Karnataka) or with world-class R&D capabilities supplier of active ingredients other partnerships. The in Huddersfield-UK and for home and personal care, current portfolio consists of Hyderabad-India with scientists hair dyes, imaging chemicals 100+ products serving 300 having a combined dye and photochromic. It Maintains + Customers with supply chemistry experience of more leadership position through expertise for any volumes. than 100 years. captive manufacturing The Company maintains
1 1 12 Manufacturing R&D facilities Contribution to revenue (%) facilities Annual Report 2018-19 15 2018-19 in a nutshell
Performance (in FY2018-19) 13,151 2,001 574 Revenue EBITDA Net Profit (` million) (` million) (` million)
Position (as on March 31, 2019) 9,437 13,480 Networth Tangible Assets (` million) (` million)
Key events (in FY2018-19)
May 2018 October 2018 Pharma Science Limited Vivimed Labs Spain S.L, the Vivimed’s API manufacturing and the balance 50% stake parent of UQUIFA S.A, has facility located in CUERNAVACA, in Strides Vivimed Pte Ltd, signed definitive agreements Mexico was recently inspected Singapore to Strides Pharma to facilitate the acquisition by the US FDA in compliance Global Pte, Singapore. of SONEAS, a Budapest with their requirements. The (Hungary) headquartered inspection was successful and CDMO company, focussed on company obtained EIR. the Innovator Pharmaceutical and Fine Chemical sectors. The January 2019 business has been acquired Vivimed’s Board approved to from Lochlomond and sell its stake in 50:50 JV with Euroventures which are both Strides. Consequently, VLL based out of Hungary. SONEAS will Sell balance 50% stake in has for the year 2017, reported Vivimed Life Sciences Private revenues of €12.2mn. Limited, India to Strides VIVIMED LABS LIMITED 16 Financial progress 4,106 11,857 13,564 13,152 14,619 2,429 2,216 2,001 FY 2015-16 FY 2016-17 FY 2017-18 FY 2018-19 FY 2015-16 FY 2016-17 FY 2017-18 FY 2018-19
Revenue EBIDTA (C million) (C million) 12,387 2,217 9,437 7,342 5,852 837 761 574 FY 2015-16 FY 2016-17 FY 2017-18 FY 2018-19 FY 2015-16 FY 2016-17 FY 2017-18 FY 2018-19
Profit for the year Networth
(C million) (C million) Annual Report 2018-19 17 Management Discussion & Analysis
Global economy Indian economy (both Centre and State) on construction of rural roads, One year ago, economic activity Fiscal 2018-19 was a year of highways, and affordable was accelerating in almost all benign growth for the Indian housing. regions of the world and the economy. Growth dropped to global economy was projected 6.8% in FY19. Outlook for FY20 to grow at 3.9% in 2018 and Food Inflation could be So what led to the decline? 2019. And in that one year, a reason for worry for India started on a healthy note a lot has changed which has policymakers in FY20, with an 8% GDP growth in the contributed to a significantly given that it has remained first quarter and a 7% growth in weakened global expansion, subdued for a considerable the second. But in the second especially in the second half period. of 2018. With this weakness half growth slipped to below Fuel Inflation might be under expected to persist into the 6.5%. This was due to the poor control in FY20 given the first half of 2019, the World performance of farm, mining trend in global crude oil Economic Outlook projects a and manufacturing sectors – it prices, which have come off decline in growth in 2019 for led to an overall deceleration in their peak in October’18 with 70% of the global economy. economic progress. low probability of rebounded Global growth, which peaked at During the year private final to those high levels. close to 4% in 2017, softened to consumption expenditure grew 3.6% in 2018, and is projected Current account deficit is 8.1% and capital investment as to decline further to 3.3% in expected to reduce to 2.4% measured by gross fixed capital 2019. of GDP in FY20, compared formation expanded from 9.3% to 2.6% in FY19. The import to 10% in FY19. However, the Changes that derailed the bill is expected to be lower, slowdown in Agriculture and world from becoming better consequent to lower oil Manufacturing has been a The escalation of US–China prices. However, exports will major cause of concern. trade tensions also languish on the back of weak global growth outlook Macroeconomic stress in On the investment front, FY19 and global trade impacted by Argentina and Turkey witnessed a rebound with escalating trade wars. Disruptions to the auto fixed investment growing The Indian rupee will remain sector in Germany 12.2% from 7.6% in FY18. The investment ratio has also volatile and settle at 72/$ Tighter credit policies in seen an uptick from 30-31% by March 2020. Again, the China
VIVIMED LABS LIMITED in FY18 to 32.9% in FY19. The low oil prices and slowing Financial tightening in the impetus has come in the form rate of monetary policy larger advanced economies of huge Government spending normalisation will act as 18 Global Medicine Spending and growth in Selected Regions, 2018-2023
UNITED STATES TOP 5 EUROPE 2018 : $485Bn +5.2% 2018 : $178Bn +3.9% 2014 -18 : 7.2% 5 year CAGR 2014 -18 : 4.7% 5 year CAGR 2019 : $507Bn + 4.6% 2019 : $182Bn + 2.8% 2023 : $625-655Bn+4.7% 2023 : $195-225Bn+1-4% 5-year CAGR 5-year CAGR
WORLDWIDE PHARMERGING JAPAN 2018 : $1,205Bn +4.8% 2018 : $286Bn + 6.9% 2018 : $86Bn + 1.8% 2014 -18 : 6.3% 5 year CAGR 2014 -18 : 9.3% 5-year CAGR 2014 -18 : 1.0% 5 year CAGR 2019 : $1,245Bn +4.5% 2019 : $293Bn+7.0% 2019 : $89Bn + 0.9% 2023 : $1,505-1,535Bn+3-6% 2023 : $355-385Bn+5-8% 2023 : $89-93Bn+ (-)3-0% 5-year CAGR 5-year CAGR 5-year CAGR
a support for the Indian of healthcare and spend owing to the impending slack currency. continues to occupy sizeable economic conditions across Domestic Interest rates mind space of policy makers, the advanced economies which are also expected to head patients, payers and drug will have a spillover impact southward, the dampening manufacturers. on the progress of the Global mood of consumption in Pharmaceuticals Industry. The global market for household sector will be a pharmaceuticals reached key catalyst for rate to hover US$1.2 trillion in 2018, up lower than FY19. US$100 billion from 2017, (Source: Ministry of Finance, according to the Global Use The Economic Times, CRISIL of Medicines report from the Research) IQVIA Institute for Human Data Science. For the US specifically, The Indian economy is the 2018 spending was US$485 expected to grow at 7.0% billion, up 5.2% over the Trends expected to play in FY20 owing to internal previous year. out between 2019 and 2023 challenges such as a weak Uptake of newer brands domestic demand forecast. The growth phase of the and products is expected Global Pharmaceuticals to remain strong market is expected to continue Global Lesser impact of price unabated in the next five year cuts on brand than other pharmaceutical cycle. Driven mainly by higher products sector spending on medicines, it is The global pharmaceutical expected that the market size Generic usage in the industry has remained in the will reach US$1.5 trillion by unprotected markets to spotlight in almost every nation 2023, growing at 3-6% CAGR exceed the target (80%) for its strong correlation with which is comparatively lesser Product mix to continue its shift towards specialty the nation’s economic strength than the growth over the Annual Report 2018-19 and improved standards of last five years (5-6% CAGR). and orphan products healthcare. As a result, quality This subdued demand is 19 Global API sector and specialty APIs, in order to Despite these headwinds, China dominates the global cater to the rising demand for overall export of API space is largely owing these products. pharmaceutical products stood to consistent investment in at an all-time high, crossing the business-critical factors such as Indian US$19 billion mark in 2018- chemistry expertise, technology pharmaceutical 19 against US$17.27 in the and large infrastructure. sector previous fiscal. The global API market The third largest in the world Optimism and outlook: The by dint of volume growth, the witnessed steady growth in Industry is expected to grow Indian Pharmaceutical industry 2018 in terms of volume and at a CAGR of 15% over the supplies around 50% of the value despite disruptions from next few years from the value global demand for various the conventional supplier base. of $38billion in 2019. It has vaccines, 40% of generic The Chinese Government’s played a key role in bringing drugs in the US and 25% of all efforts to curb pollution about better health outcomes medicine demand in UK. impacted certain API and across the world through its intermediate manufacturing India’s domestic cost-effective and superior zones, mandating them to pharmaceutical turnover quality generics drugs. Better shut operations. The resultant reached C129,015 crore (US$ accessibility to reasonably production shortfall impacted 18.12 billion) in 2018-19, priced drugs has been one of the price and supply of growing by 9.4% year-on-year the key enablers for lowering these products across the from C116,389 crore (US$ the disease burden in India. pharmaceutical value chain 17.87 billion) in 2017-18. The India’s per person disease globally. healthy uptick was owing to burden measured as Disability the lower base of the previous Adjusted Life Years (DALYs) Going forward: The market year (2017-18) and the limited dropped by 36 percent size of the Global active impact of the Fixed-Dose between 1990 and 2016 after pharmaceutical ingredients combination ban during the adjusting for changes in the market as of 2018 was valued period under review. population age structure. at US$165.74 billion; this size is expected to grow to US$236.7 Fiscal 2018-19 was challenging The demand in the billion by 2024 growing at a for some of the leading Indian pharmaceutical industry will pharmaceutical companies CAGR of 6.1%. remain high and hence act as a having a sizeable exposure to market driver on account of the The major forces that are the US markets. Regulatory following: driving the market include challenges linked to plant- the increasing prevalence specific issues and/or price The expected spend on of infectious diseases, erosion in the base portfolio medical infrastructure in the cardiovascular conditions, and resulted in a decline in their US next couple of years will be other chronic disorders. Apart business. to the tune of US$200billion. from these diseases, genetic disorders are significantly driving the usage of active I SD
ingredients worldwide. 11-12%