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.