Wockhardt Ltd Management Discussions.
In India, growth has been moderate during the year owing to slower growth in consumptions and investment. Rising interest rates and currency volatility are weighing on activity. By contrast, central banks in China and India maintained policy rates on hold and acted to ease domestic funding conditions. With investors generally lowering exposure to riskier assets, emerging market economies experienced net capital outows in the third quarter of 2018. The Companys US business continues to be impacted because of market/channel consolidation which has put pricing pressure on one hand while more and more generic players continue to be contributor to the competition. However, some of the strategic initiatives of the company undertaken well in advance contributed positively in US & UK market o-setting some of the adversities of the market. FY 2018-19 witnessed certain key events globally, which are the future growth triggers for your company. With an aim to grow and further establish their international presence in pharmaceutical manufacturing, Wockhardt inaugurated a state-of-the-art manufacturing facility for the production and packaging of sterile dry powder injection in Dubai. On approval of the new drug by US FDA, this manufacturing facility will be commissioned for commercial production. This facility reinforces the companys focus on commitment in developing (New Chemical Entities) NCEs. Your Company has been building as a priority area for the US business, portfolio of oncology products in the US and has several pending ANDAs for oncology products. The direct outcome of these eorts translated into approval of Imatinib Mesylate tablets which are a generic version of Gleevec by Novartis. Adding to this list during the year, your Company also received approval for Decitabine which is generic version of Dacogen by Otsuka and Abiraterone acetate tablet i.e generic version of Zytiga by J&J. Further, expansion of businesses in newer horizons continues to be on the radar with top priority to remediation eorts for obtaining US FDA clearance. Companys focus on cost containment and rationalisation continues delivering its intended positive impact on protability in spite of ongoing remedial measures.
During the year, the Companys research & development expenses continued to grow keeping in view its strategic focus in Pharma, Biotechnology & NCE segment and was about 7% of consolidated revenue.
Revenue from Operations during the year was Rs. 4,158 crore compared to Rs. 3,937 crore in the previous year.
Rs. in Crore
|FY 19||FY 18||Change||% Change|
|Revenue from operations||4,158||3,937||221||5.6%|
On a quarterly basis, revenues in the rst three quarters gained momentum and were on the higher side. However Q4 was slightly on lower side as compared to PY.
The revenue split of US operations stood at 19% (compared to 17% as in FY 2018) while European Business contributed 32% (compared to 34% in FY 2018). India and Rest of the World continue to grow and contributed a robust 49% (in line with FY 2018).
The Gross Margins have consistently stayed around
56% in all the quarters which is in line with previous year quarters.
On Y-o-Y basis EBITDA has improved mainly on account of improved top-line across businesses. Remedial costs towards ongoing US FDA issues continue to be in place, oset partially by cost containments & rationalisation measures. However, Companys strategic focus on R&D initiatives that are futuristic in nature, continue to impact the EBITDA as they are being expensed
Material Consumption for FY 2019 stood at 43% of sales compared to 45% in FY 2018.
The Companys emphasis on R&D continued during the year while adopting selective strategy for rationalizing R&D spends which is reected in spends for FY 2019 at 7%. Personnel costs were lower than PY at 20%.
Other expenses for FY 2019 were at 26% of sales compared to 28% in the previous year which is direct outcome of aggressive cost containment measures adopted by the Company. Interest cost was higher compared to previous year. Other Income was lower than the previous year at Rs. 21 Crore. PY had signicant Interest income on surplus funds. Exceptional items in PY includes one time expense of Rs. 358 Crore on account of Teva litigation.
The Companys EBITDA margins are better as compared to previous 2 years which is outcome of better gross margins and aggressive cost containment measures.
DEBT AND LEVERAGE
The Net Debt to Equity ratio stood at 0.97 as on 31st March, 2019.
Rs. in Crore
|FY 19||FY 18||Change||% Change|
Industry R&D Pipeline :
Worldwide pharmaceutical R&D spend totalled $179bn in 2018 representing an increase of +6.5% on the previous year. Going forward, R&D spend is forecast to grow at a CAGR of 3% to 2024. This is lower than the CAGR of 3.6% between 2010 and 2017.
Similarly, the average annual proportion of forecast R&D spend to pharmaceutical revenue is expected to be 18.9%, lower than the 19.5% observable between 2010 and 2017. This reduction signals expectations that proportionally either companies will be improving R&D eciencies or perhaps, that less revenue will be directed towards replenishing pipelines.
Worldwide Total Pharmaceutical R&D Spend in 2010-2024
RESEARCH & DEVELOPMENT : COMPANYS STRATEGIC CORE
The Companys continuous strategic focus in complex research in Pharma, Biosimilars & NCEs for past couple of years have shown encouraging results particularly in the eld of Break through Anti-infective space.
GLOBAL ANTIBIOTIC MARKETS & ANTIMICROBIAL RESISTANCE LEVEL CRISIS
Antimicrobial resistant (AMR) or the ability of infections to resist antibiotics to work against it could negate many of the medical breakthroughs of the last century. Previously curable infectious diseases may become untreatable and spread throughout the world. The report Antimicrobial resistance: Global report on surveillance showed that antimicrobial resistance is prevalent everywhere and has the potential to aect anyone, of any age, in any country. Antimicrobial resistance is putting at risk the ability to treat even common infections both in the community and hospitals and without an urgent and coordinated action the world is heading towards a post-antibiotic era.
Antimicrobial resistance (AMR) is increasingly recognised as a growing global health problem. Without eective antibiotics, infections become more dicult to treat, and medical and surgical procedures can become high-risk interventions. Antimicrobials are losing their eectiveness at an increasing rate, accelerated by their misuse in humans and in the agricultural sector. To slow the rise of resistance, antimicrobials must be used only when needed. Global stewardship strategies are being developed that address how antimicrobials are used in humans and animals, as well as the antimicrobial load in the environment. AMR strategies also focus on developing new antimicrobial medicines to replace those that are becoming less eective.
Burden of resistance to antibacterial drugs
The overall health and economic burden resulting from acquired AMR cannot be fully assessed with the presently available data, however some estimates of the economic eects of AMR have been attempted, and the ndings are disturbing. In a WHO report on Antimicrobial Resistance: Global Report on Surveillance (2014), the yearly cost to the US health system alone has been estimated at US $21 to $34 billion dollars, accompanied by more than 8 million additional days in hospital1 Because AMR has eects far beyond the health sector, it was projected, nearly 10 years ago, to cause a fall in real gross domestic product (GDP) of 0.4% to 1.6%, which translates into many billions of todays dollars globally1.
The evidence obtained shows that AMR has a signicant adverse impact on clinical outcomes and leads to higher costs due to consumption of health-care resources. Infections caused by antimicrobial resistant strains of bacteria are unlikely to respond to standard treatments resulting in prolonged illness and a greater risk to health. For example, MRSA (Methicillin-resistant Staphylococcus aureus) is estimated to cause 64% more deaths than infections caused by a non-resistant strain of the bacteria2 as per a report published in 2015 (The Antibiotic Resistance Crisis- by C.Lee Ventola) Antimicrobial resistant strains of bacteria are also more likely to be passed on to other people because those infected are sick for longer. The ONeill Review (The Review on Antimicrobial Resistance, December 2014) estimated that the global impact of AMR could be 10 million deaths annually by 2050, and cost up to US $100 trillion in cumulative lost economic output3. The nature of this global problem emphasises the challenge that the UK faces when tackling AMR in the food supply chain.
Antimicrobial resistance (AMR) is a widely recognised and growing global public health problem. Though there are no exact gures that capture the true global burden of AMR, let alone in low- and middle-income countries (LMICs), latest estimates from the Antimicrobial Resistance Benchmark 2018, show that AMR causes over 700,000 deaths annually worldwide4. At the same time, millions of people lack access to much needed antimicrobial medicines for curable infections, which is evident by the 445,000 community-acquired pneumonia deaths that occur in children under ve4. The issue of AMR and lack of access must be addressed in tandem. Steps to increase access must include measures to prevent resistance, and steps to curb resistance must include measures to enable appropriate access. Addressing both requires a coordinated eort from various stakeholders, not least in government, but also across the healthcare and farming industries, and the development and global health communities
The global market for Antibiotics, Vaccines & Diagnostics reached USD 108.4 billion in 2015, and is forecast to reach USD 183.2 billion in 20214. The antibiotic market is expected to grow from USD 27.1 billion in 2015 to USD 35.6 billion in 2022, in step with growing demand for generic antibiotics from emerging markets4. Between 2002 and 2010, global consumption of antibiotics increased by 36%, and three quarters of this increase was accounted for by Brazil, Russia, India, China and South Africa (BRICS)4. Growing demand coupled with poor surveillance and stewardship is likely to further drive the emergence of resistant strains, particularly in high-burden areas.
Signicant Decline in Antibacterial Drug Approvals4
There has been a steady decline in the number of the new antibacterial drugs approved and the decline in new antimicrobial agents along with the need to manage an increasingly complex health care environment may require even more robust activity and innovative solutions. In the near future, the next challenge will be to identify newer agents for the treatment of multidrug-resistant Gram-negative pathogens which are emerging at a rapid rate.
It is essential to take appropriate measures to preserve the ecacy of the existing drugs so that common and life-threatening infections can be cured.
Facts about Antibiotic Resistance5 (Antibiotic Resistance Threats in the United States, 2013- by Centers for Disease Control and Prevention -USA)
Antibiotic resistance is one of the most urgent threats to the publics health.
Every time a person takes antibiotics, sensitive bacteria are killed, but resistant ones may be left to grow and multiply.
Overuse of antibiotics is a major cause of increases in drug-resistant bacteria.
Overuse and misuse of antibiotics threatens the usefulness of these important drugs. Decreasing inappropriate antibiotic use is a key strategy to control antibiotic resistance.
Antibiotic resistance in children and older adults is of particular concern because these age groups have the highest rates of antibiotic use.
Antibiotic resistance can cause significant suffering for people who have common infections that once were easily treatable with antibiotics.
When antibiotics do not work, infections often last longer, cause more severe illness, require more doctor visits or longer hospital stays, and involve more expensive and toxic medications. Some resistant infections can even cause death.
AMR is a global health security threat that requires concerted cross-sectional action by governments and society as a whole. The overuse of antibiotics clearly drives the evolution of resistance. Epidemiological studies have demonstrated a direct relationship between antibiotic consumption and the emergence and dissemination of resistant bacteria strains. In emerging economies like Middle East , Latin America, Asia Pacific are important for the future growth drivers and one can expect the rising trend to continue for the next decade amidst unanimous shift in focus to put issues pertaining to AMR and Antibiotic access on the world priority list.
1 Antimicrobial resistance: global report on surveillance 2014
2 The Antibiotic Resistance Crisis PMCID: PMC4378521; PMID: 25859123
3The Review on Antimicrobial Resistance, Chaired by Jim ONeill
4 Anti microbial Resistance Benchmark 2018
5Antibiotic Resistance Threats in the United States, 2013- by Centers for Disease Control and Prevention (USA)
US, UK, Europe, India and other Emerging markets continue to oer a plethora of opportunities because of transition in the form of lifestyle shift & related diseases in these countries. Because of the existing presence of operations in these economies your Company is well poised to capitalise and tap these growth opportunities. Your company is striving in all aspects to establish its brand and ramp up its presence and operations in larger GCC countries, Latam Countries, New markets like Australia, New Zealand, Turkey, Malaysia and not last but signicant partnerships in China, Japan and Korea.
Global crisis of antibiotics availability continues to pose threat and the gap in Anti Infective segment has widened as relatively few drugs have been discovered in the last decade. However your Companys relentless focus for almost two decades in the Anti-Infective space has started showing recognition with consecutive approvals for QIDP in quick successions as well as approval from US FDA by granting abridged clinical trial for Phase III for its Superdrug antibiotic WCK 5222. This was based on the evaluation by US FDA of its preclinical and clinical data of Phase I establishing safety and clinical scope of ecacy for the drug. With the rise in number of new organisms and new strains of old organisms with significant resistance to existing medicines, the Company with its array of under-development drugs in this space aims to counter these unmet needs in both gram positive and gram negative bacterial infections in both regulated and unregulated markets. During the past years (2014) and (2015) approvals were received for 5 novel antibiotics making it the only Company globally to receive QIDP status for 5 drugs from US FDA. Qualified Infectious Disease Product (QIDP) is granted to drugs, identified by Center for Disease Control (CDC), USA that act against Pathogens which have a high degree of unmet needs in their treatment.
Over last 10 years global patents filed for antibacterial have declined by 60%, whereas patents filed by Wockhardt in these 10 years have increased by 315%.
While standard drug classes go o-patent and generics and bio-similars gain steam in time to come, new wave of innovation continues to replenish the pipeline and provide essential therapeutic advances for patients. These innovations are in the orphan disease segment and also long term acquired chronic diseases which aect large population and drives healthcare costs. In addition to novel medicines, platform technologies that may transform care across multiple potential disease targets, like gene editing, regenerative cell therapies, and new approaches to targeting disease through the gut microbiome or replacing blood components with those from healthy individuals are set to evolve.
Technology trends are driving a shift towards patient-centric healthcare, as evidenced by wearable biometric devices and telemedicine. This trend is resulting in more informed patients who are likely to take a more active role in any treatment plan their doctor may prescribe. Patient-centric care can provide challenges and rewards for the pharmaceutical industry. In 2019 and beyond, the direct consumer may become the pharmaceutical companys most strategic partner. The rise of consumerism provides an interesting dynamic for competition in this industry.
Quality compliance, globally, has gained signicant impetus and has emerged as a key success factor for long term sustenance. Global Regulatory management continues to remain key focus area for entire pharmaceutical industry with regulatory agencies continuously enhancing the benchmark at regular intervals. The evolving cGMP regulations have become stringent and the industry is striving unanimously to create world class capabilities to adhere to the mandates. Corrective measures for US FDA clearance are still in process with signicant automation, technology upgrades and rollout of best practices at the manufacturing facilities. Your Company is monitoring the situation closely and is working with best of class consultants for resolution. Risk of regulatory quality compliance shall continue to remain critical for your Company in future. Pricing pressures in India continue to impact several organizations with latest NPPA circulars to include many critical drugs under the scope of price xation / reduction. This has impacted the earnings of many Indian companies including yours. Amidst such challenges the company has put remediation measures in place while ensuring growth and strengthening of its other business which consists of new product portfolio and better brand management.
Last year has witnessed volatility on political front and macro-economic parameters globally. Most importantly the series of events across globe which have occurred, shall determine the course of global economic growth in time to come. Key events which may have impact on the businesses of the Company are Political changes in US, protectionist policies in some of the economies, BREXIT, global crude oil prices, devaluation of major currencies vis--vis dollar.
In 2019, World leaders will face a tough time keeping the global recovery on track, even while wars, terrorism and other threats add to the challenges. Your company is a global player and is not insulated against such external risks despite the best nancial practices and wide range of measures being taken. This has also to some extent impacted the earnings w.r.t. to countries where your Company operates in the home currency of these nations. This inherent risk will continue to pose challenges to a Company like yours that has a signicant share of revenues from cross border operations.
Research Eorts in Novel Drug Delivery Systems and ANDAs Pipeline
During the financial year ended March 31, 2019 the Company has filed 3 new products in UK and has received an approval for 2 new products (ANDAs) in US. Currently for the US business, Companys pipeline includes 58 products pending to be approved by US FDA. The Company has always been a trendsetter in Indian generic pharma industry with its niche NDDS products like Metoprolol ER, Divalproex ER, Tamsulosin ER which were among the first few generics in US market. Pending ANDAs include complex generics and modified release formulations. It has also made advancements in the area of characterisation of complex muco-polysachharides and complex delivery technologies, integrating IT system with generic applications and has successfully developed its own patented REMS (Risk Evaluation and Mitigation Strategy) system for narrow therapeutic index medicines.
New Drug Discovery Programme of Wockhardt
As against most of global innovator companies which have focused on lifestyle segment and oncology, your Company continues to focus on New Drug Discovery Program in unmet needs in Antibacterial infections in both Gram positive and Gram negative terrain where there is dearth of medicine across the world.
Anti-Infectives are the only class of medicines which has a curative therapeutic outcome and hence the merits of drug candidates in this class are decided based on clinical ecacy against resistant, dicult-to-treat organisms.
With the global rise in the prevalence of resistant strains, and the emergence of newer resistance mechanisms as well as new pathogenic organisms, where the existing antibiotics are having little impact, the overall infectious disease scenario is highly concerning. The Company with its array of drugs under development in this space aims to counter these diseases in both regulated and unregulated markets.
Current status of QIDP products : Spurring Clinical development of NCEs in dierent territories:
WCK 5222: During the year, your Company obtained concurrence of EMEA and the Chinese Regulator NMPA (National Medical Products Administration) for WCK 5222 abridged Phase 3 study protocol. NMPA also concurred that WCK 5222 addresses unmet need for China. Moreover, for the first time, a basic manufacturing technology for the sterile Zidebactam and WCK 5222 clinical formulation was established at FDA approved contract manufacturing sites in Europe. Phase 3 cUTI study is expected to begin in Q3 of 2019-20.
WCK 4282: Phase 3 study protocol nalized in consultation with US FDA and EMA, study to commence in Q4 2019-20. Chinese NMPA concurred that product meets unmet medical need.
WCK 4873: Obtained Indian regulator DCGIs approval for initiating Phase 3 study in India for the indication of community acquired pneumonia. Similar approval is being sought from LATAM region. Phase 3 study is schedule to commence in Q3 2019-20.
WCK 771 & WCK 2349: Phase 3 study was completed for both WCK 771 (IV) and WCK 2349 (Oral). The study demonstrated that both the NCEs are comparable to standard of care MRSA drug Linezolid. A New Drug Application (NDA) was filed in January 2019 for both the products which represents the rst ever India discovered antibiotics undergoing successful Phase 3 study. NDA review is at advanced stage with IND committee of DCGI.
All the above NCEs, have distinction of QIDP status by US FDA.
Your Company has strong focus in developing intellectual property and filed 95 patents during the year under review. During the year 66 patents were granted. Thus, year after year a high success rate for the grant of NCE patents is maintained. As on 31st March, 2019, combined pool of Companys patent has reached 3,132 filings and 694 grants.
Biotechnology Research of the Company
Development of Biosimilars and Biobetters is our Biotech R&D teams primary focus area. Biotechnology is viewed by global experts as the pharmaceutical technology of the future, and we have a very strong commitment to this field. Our highly accomplished multidisciplinary team of committed biotechnologists, biochemists, biophysicists, biochemical and chemical engineers as well as protein chemists is poised to develop biological drugs to address unmet clinical needs. Our Biotechnology R&D team has succeeded in developing and commercializing Recombinant Hepatitis-B Vaccine (Biovac-B), Recombinant Human Erythropoietin (WEPOX), Recombinant Human Insulin (Wosulin), Recombinant Insulin Glargine (GLARITUS), which have all been well received in the market.
We also have a robust pipeline of recombinant therapeutic proteins for major healthcare needs. Out of these Recombinant Interferon Alfa 2b and PEGylated G-CSF have already been approved for manufacturing and marketing in India. Other products at different stages of development are: Recombinant Insulin analogues (Insulin Aspart, Insulin Lispro), Recombinant Darbepoetin, a GLP-1 agonist and therapeutic monoclonal antibodies etc.
E. coli based platform technology for Insulins has started displaying its potential, as revealed by the scale up studies in Project E, promising more than 24 Kg/batch in Project C and a capacity of ~3 tons/year in the existing plant and with DSP up-gradation a capacity of >6 tons/annum is achievable. The platform technology offers opportunity with surmountable challenge to replicate the same for other insulin analogues.
Insulin for insulin resistant/higher BMI diabetic patients:
In-house developed Biobetter Recombinant Human Insulin (200IU/mL): Consegna R and Consegna 30/70, have already been launched in India. With 50% volume reduction per dose, Consegna which promises reduced pain and better compliance has been well received in the market.
Biotechnology team is also developing other Biobetter drugs like combination of insulin and insulin analogues; insulin/ insulin analogues and GLP-1 agonist for addressing the patients needs, particularly of insulin resistant/higher BMI diabetic patients.
The Companys long term outlook continues to be promising given the following: a. Overall growth in the global pharmaceutical industry b. Continued focus on R&D in regards to its complex generic, bio technology and NCE programs. c. Companys global reach in regulated market and continued eorts to enhance its reach in emerging markets. d. Increasing pipeline of niche & complex technology generic products
The Company is exclusively into pharmaceutical business segment.
DETAILS OF RATIOS
Significant changes exceeding 25% vis-a-vis immediately preceding financialyear was reported in the following ratios:
|a) Interest coverage ratio||(0.26) to 0.59||- Favourable|
|b) Operating prot margin||(1%) to 3%||- Favourable|
|c) Net prot margin||(15%) to (5%)||- Favourable|
|d) Return on Networth||(4%) to (2%)||- Favourable|
There was a positive increase in the ratios such as Interest coverage, Operating Prot margin and net prot margin due to increase in revenue and operations and signicant improvement in EBITDA. Return on Networth improved due to improvement in operation and one-time exceptional expense in the previous year.
Current Ratio declined from 3.07 to 2.13 due to decrease in cash and bank balance on repayment of debt.
INTERNAL CONTROL SYSTEMS AND ADEQUACY
The Company has internal control procedures commensurate with its size and nature of the business. These business procedures strive to optimum use and protection of the resources and compliance to the policies and procedures. The internal control systems provide for well-dened policies, guidelines and authorizations and approval procedures. Internal audits are performed to test the adequacy and eectiveness of the internal controls laid down by management and to suggest improvements.
Internal Financial Controls laid out by the Company in accordance with the requirement of the Companies Act, 2013, were tested by Management using a self-assessment Tool implemented with the assistance from M/s Ernst and Young.
The Company has adopted a co-sourced model for internal audit. The internal audit team is assisted by M/s. Ernst & Young who carried out internal audit reviews in accordance with the approved internal audit plan. Internal audit team reviews the status of implementation of internal audit recommendations. Summary of Critical observations, if any, and recommendations under implementation are reported at quarterly Audit Committee meetings.
Wockhardts talent base, as on March 31, 2019 stands at 5,840.
Wockhardt recognizes that Associates are the most valuable assets and always encourage them to meet business requirements while meeting their career aspirations. The Human Resource division mainly focus on supporting the business in achieving sustainable and responsible growth by building the right competencies and capabilities in the organization. It continues to emphasize on progressive Human Relations policies and building a high-performance ethos with a progressive mind-set where Associates are Empowered, Engaged, Productive and Ecient.
At Wockhardt, Life Wins is a simple yet profound theme that defines our efforts, reflects our goals, highlights our and characterises our business. Our One Wockhardt motto creates a unique value driven, high performance and business driven work culture. At Wockhardt, HR plays a central role in implementing the organisations vision and strategy by aligning HR to the business. Better HR policies provides more innovative and forward looking HR focus and initiatives. Promoting diversity, learning environment and work-life balance establish a credible and integrated employee performance goal setting. We are very happy to share that Wockhardt has been adjudged as recipient of prestigious GOLDEN PEACOCK HR EXCELLENCE AWARD 2018 as a Winner by Institute of Directors in pharma sector. The Wockhardt Way, our nine core values of Winning, Openness, Courage, Knowledge, Humility, Ambition, Reputation, Depth and Trust are the fundamental principles on which we have built our business. We truly believe that the progress of our Associates and business are interlinked and thus created a work culture that oers a unique combination of our core values and functional prociency. At Wockhardt, we believe that Associates are the key players in business success & sustainable growth. In order to provide meaningful opportunities to our Associates for learning and growth, we have strengthened our internal talent management pool by launching various career programs for our eld associates, Emerge, Surge and Upsurge which provides career visibility to development to our sales force.
In addition, we also launched our premier leadership development initiative called WOCKLEAD which aimed at identifying potential talent pool among business heads in India Business. In this program, the associates are mapped on critical functional and behavioural competencies, with an aim to work on their strengths and areas of development through career conversations and leadership guidance to identify current job role t and potential job role t.
Your Company introduced several interventions for creating a culture of discipline and compliance, such as revamping our existing learning systems, rewards and recognition framework aligned to desired performance and business outcomes, enhancing Associate connect through Town halls, PACE Nite, On the spot recognition, Learning initiatives, Internal newsletters and communication.
The Companies Whistle Blower Policy which encourages the Whistle Blower to report genuine concerns or grievances of illegal, unethical or inappropriate events (behaviour or practices) that aect Companys interest / image. It also provides adequate safeguard to the Whistle Blower against victimization. The policy is available on the companys website at www.wockhardt.com