Wockhardt Ltd Management Discussions.

Global Arena

Globally, growth has been muted owing to slowdown in consumptions, trade & investment and probably was the lowest since the global financial crisis. This weakness was widespread, a_ecting both advanced economies—particularly the Euro Zone and also emerging market and developing economies. In particular, global trade in goods was in contraction for a significant part of 2019, and manufacturing activity slowed markedly over the course of the year. Most of the year was dominated by heightened policy uncertainty and trade disputes between the two largest economies which weighed on international trade, investments and con_dence. Concerns about growth prospects triggered widespread monetary policy easing by major central banks last year, as well as _ight to safety flows into advanced-economy bond markets. The subdued outlook also led to declines in most of the commodity prices. In the near term, monetary policy across the world is generally expected to remain accommodative. The first quarter of 2020 saw an unprecedented outbreak of COVID-19 pandemic which caused an all-round disruption of economies around the world and dampened the already bleak economic prospects. It has proved to be one of the most damaging event of human history and believed to have deep and cascading impact across the entire economic chain. To add to the global woes the crude oil prices sunk to its lowest level ever which has been known in decades indicating slow down across the industries and economies. The intense and deep rooted damage caused by the above two events is reflected in the IMF outlook of 2020 (Fig below) which sees most of the major economies ending this year with negative output.

Economies 2019 2020 2021
World Output 2.9 (3.0) 5.8
Advanced/Developed 1.7 (6.1) 4.5
o/w US 2.3 (5.9) 4.7
o/w EU 1.2 (7.5) 4.7
o/w UK 1.4 (6.5) 4.0
EM,s/Developing 3.7 (1.0) 6.6
o/w China 6.1 1.2 9.2
o/w India 4.2 1.9 7.4

 

Source : IMF, World Economic Outlook, April 2020

Company Performance

(In below entire Management Discussion & Analysis, figures, ratios and percentage are inclusive of continuing and discontinued operations of Consolidated financials)

The Companys International businesses continues to be under pressure because of channel consolidation which has put pricing pressure on one hand while more and more generic players continue to be contributor to the competition. On the Domestic business front there was de-growth but mostly within the low margin generics segment and secondly as result of outcome of portfolio re-shuffling within the branded formulations business. Striking an appropriate balance within debt servicing obligations and ensuring that flow of working capital continued in the businesses remained the key challenge during most of the year which was another factor responsible for de-growth of businesses. Another important step amidst the above challenges were to rationalize the overall business portfolio and move towards ensuring robust operational cost optimization which is reflected positively in the financials. With the tightening of monetary condition across the globe and amidst industry and Business slowdown, managing liquidity has been the key priority during the year and your company has e_ectively managed its liquidity position and continued with its sustainable business model without compromising on the overall long term vision of the organization.

FY 2019-20 witnessed one of the most strategic event executed on the India Branded Business front in the form of part divestment of its Domestic Branded Business to Dr Reddys laboratories comprising of 62 Brands and related Business assets, liabilities along with the manufacturing plant at Baddi, Himachal Pradesh, India. The intended sale of Business portfolio is in line with the Companys strategic plan to shift from acute therapeutic areas to more chronic business like anti-diabetes, CNS etc. and also to its niche antibiotic portfolio of NCEs. The divestment will also ensure adequate liquidity to bring in robust growth in the chronic domestic branded business, international operations, investments in Biosimilars for the US market apart from the Companys Global clinical trials of Break-through Anti-Infectives. Also, during the year, in another major path breaking development and aligning with the companys vision to strengthen its NCE presence amongst extremely limited world players, the Indian drug regulator, DCGI has approved Wockhardts 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).

Further, expansion of businesses in newer horizons continues to be on the radar with top priority to remediation efforts for obtaining US FDA clearance. Companys focus on cost containment and rationalisation continues delivering its intended positive impact on Profitability 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 6.3% of consolidated revenue.

REVENUES

Revenue from Operations during the year was Rs. 3,325 crore compared to Rs. 4,158 crore in the previous year with a decrease of 20%.

The revenue split of US operations stood at 22% (compared to 19% as in FY 2019) while European Business contributed 35% (compared to 32% in FY 2019). India and Rest of the World De-grew YoY but still contributed a robust 43% (compared to 49% in FY 2019).

PROFITABILITY

The Gross Margins have improved in all the quarters ranging from 59% in Q1 to 60% in Q2/Q3 and then 62% in Q4. This is significantly higher than all the previous year quarters wherein the GC% were in the range of ~55 – 56%. This is mainly the outcome of re-alignment and shift of Businesses in favour of high margin portfolios.

On Y-o-Y basis EBITDA has improved mainly on account of re-alignment of top-line across businesses in favour of high margin portfolios along with significant cost rationalisation and cost containment measures to improve the overall e_ciency. Remedial costs towards ongoing US FDA issues continues to be in place. The 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 2020 stood at 40% of sales compared to 43% in FY 2019. This is a significant improvement vis a vis all the previous year quarters which reflect the strength of the overall portfolio mix.

The companys emphasis on R&D continued during the year while adopting selective strategy for rationalizing R&D spends which is reflected in spends for FY 2020 at ~ 6.3%. Personnel costs as % to sales were higher than PY at ~23.3%. However in absolute terms the cost de-grew by 7.4%.

Other expenses for FY 2020 were at 23% of sales compared to 26% in the previous year which is direct outcome of aggressive cost containment measures adopted by the company. Interest cost both in % and absolute terms was higher compared to previous year. Other Income was slightly higher than the previous year at INR 39 Crores. Profits after Non-Controlling interest (NCI) improved from (-5%) in PY to (-2%) in FY 2020.

Particulars FY19 FY20 Change %
Material Consumption 43.4% 39.7% 3.7%
Personnel Cost 20.1% 23.3% -3.2%
R&D 7.0% 6.3% 0.7%
Other Expenditure 26.3% 23.4% 2.9%
Interest 6.4% 8.3% -1.9%
Depreciation 4.0% 6.8% -2.8%
Exchange loss/Gain 0.6% -0.6% 1.2%
Other Income -0.5% -1.2% 0.7%
Tax -2.0% -4.6% 2.6%
Profits (Before NCI) -5.2% -1.3% 3.9%
NCI -0.5% 0.8% -1.3%
Profits (After NCI) -4.7% -2.1% 2.6%

The Companys EBITDA margins (both in absolute and % terms) are the best as compared to previous 3 years which is an outcome of high margin portfolio and aggressive cost containment/ cost rationalisation measures which reflect the operational hygiene across geographies.

DEBT POSITION

Rs. in Crores

FY 20 FY 19 Change % Change
Secured 2,610 3,027 -417 -14%
Unsecured 237 5 231 +4388%
Preference Capital 350 330 20 6%
Total 3,196 3,362 -166 -5%

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 e_ciencies or perhaps, that less revenue will be directed towards replenishing pipelines.

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 a_ect 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 a major threat to human development as it a_ects our ability to treat a range of infections caused by bacteria, parasites, viruses and fungi. Treatments for a growing list of infections, including urinary tract infections, tuberculosis (TB), sepsis, gonorrhoea and food borne diseases, have become less e_ective in many parts of the world because of resistance. In the absence of an e_ective antibiotics modern medical procedures, such as major surgery, organ transplantation, diabetes management and cancer chemotherapy will become a very high risk 1, 2.

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 effects of AMR have been attempted, and the findings 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 hospital. Because AMR has effects 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 globally3.

The evidence obtained shows that AMR has a significant 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 bacteria4 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 output5. The nature of this global problem emphasises the challenge that the UK faces when tackling AMR in the food supply chain.

The cost of health care for patients with resistant infections is higher than care for patients with non-resistant infections because of longer duration of illness, additional tests and the need for more expensive medicines. The rise in resistance not only impedes our ability to treat infections, but has broader societal and economic effects, and endangers the achievement of the Sustainable Development Goals1,8. The direct and indirect impact of AMR will mostly fall on low and middle-income countries, which often lack the infrastructure, and human and financial resources to adequately counter drug resistance epidemics 8. The consequences of AMR are aggravated in volatile situations such as civil unrest, violence, famine and natural disasters, as well as in settings with poor health care services or without access to health care 2,9.

Antimicrobial resistance (AMR) is a widely recognised and growing global public health problem. Though there are no exact figures 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 _ve6. 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 e_ort from various stakeholders, not least in government, but also across the healthcare and farming industries, and the development and global health communities

The worst-case scenario in the coming would be, world might be left without any potent antimicrobial agent to treat bacterial infections. The global economic burden would be about US $120 trillion (US $3 trillion per annum), which is approximately equal to the total existing annual budget of the US health care. In general, the world population would be hugely a_ected as of the year 2050, and birth rates would rapidly decline in this scenario.9, 10

Growing Demand!

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.

Significant 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 effcacy of the existing drugs so that common and life-threatening infections can be cured.

Facts about Antibiotic Resistance7 (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 – Paci_c 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.

Reference:

1. WHO. Antimicrobial resistance (WHO Fact sheet). Geneva: World Health Organization; February 2018 (http:// www.who.int/ en/news-room/fact-sheets/detail/antimicrobial-resistance, accessed 25 September 2018).

2. Laxminarayan R, Duse A, Wattal C, Zaidi AK, Wertheim HF, Sumpradit N, et al. Antibiotic resistance-the need for global solutions. Lancet Infect Dis. 2013;13:1057– 98. doi:10.1016/S1473-3099(13)70318-9

3. Antimicrobial resistance: global report on surveillance.2014

4. The Antibiotic Resistance Crisis PMCID: PMC4378521; PMID: 25859123

5. The Review on Antimicrobial Resistance, Chaired by Jim ONeill

6. Anti-microbial – Resistance – Benchmark 2018

7. Antibiotic Resistance Threats in the United States, 2013- by Centers for Disease Control and Prevention (USA)

8. Ayukekbong JA, Ntemgwa M, Atabe AN. The threat of antimicrobial resistance in developing countries: causes and control strategies. Antimicrob Resist Infect Control. 2017;6:47. doi:10.1186/ s13756-017-0208-x

9. Gould IM, Bal AM. New antibiotic agents in the pipeline and how they can help overcome microbial resistance. Virulence. 2013;4(2):185–191. [PMC free article] [PubMed] [Google Scholar]

10. Bartlett JG, Gilbert DN, Spellberg B. Seven ways to preserve the miracle of antibiotics. Clin Infect Dis. 2013;56(10): 1445–1450. [PubMed] [Google Scholar]

OPPORTUNITIES

US, UK, Europe, India and other Emerging markets continue to o_er 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 significant 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 e_cacy for the drug.

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.

RISK & CONCERNS – Way Ahead

Last year has witnessed volatility on macro-economic parameters globally.

As the new financial year commences, the Novel Coronavirus (COVID-19) has infected more than millions of people in more than 150 countries - a scourge confronting all of humanity, impacting lifestyles, businesses, economies, and the assumption of common well- being.

Even before the onset of this pandemic, the global economy was confronting turbulence on account of disruptions in trade flows and attenuated growth. The situation has now been aggravated by the demand, supply and liquidity shocks that COVID-19 has in_icted. Once the pandemic is controlled, the shape and speed of the recovery in the US and China will be key factors determining the nature and traction of global economic recovery.

However it is expected that the course of economic recovery in India will be smoother and faster than that of many other advanced countries. Indeed, the UNCTAD in its latest report ‘The COVID-19 shock to Developing Countries has predicted that major economies least exposed to recession would be China and India.

While we are now focusing in India on securing the population from health hazards and on providing relief, especially to the poor, we also need to think long-term - to secure the health of the economy, the viability of businesses, and the livelihoods of people. Apart from providing robust safety nets for the vulnerable, ensuring job continuity and job creation is key. And there is an urgent need to mobilise resources to stimulate the economy.

Given the halt and lockdowns in almost every activity across the globe has created shock both on demand side and Supply side and led to imbalances in almost each and every corner which has a huge cost associated with it. There are seven ways in which the business landscape will shift, not only in India, but the world around. Leveraging these will certainly help navigate the economically and socially viable path to the next normal:

1) Shift towards localization

2) Push of Digital wave

3) Cash being new king for Businesses.

4) Shift towards variable cost models.

5) Supply Chain resilience

6) Building agility.

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 significant 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. Your company is a global player and is not insulated against such external risks despite 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 or where it is exposed to international transactions. This inherent risk will continue to pose challenges to a Company like yours that has a significant share of revenues from cross border operations.

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 e_cacy against resistant, diffcult-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 different territories:

WCK 5222:

An abridged Phase 3 global study protocol _nalized in consultation with US FDA , EMA and Chinese FDA (NMPA). The study is estimated to commence in second half of 2020. Investigational product manufactured for phase III trials at FDA approved contract manufacturing sites in Europe.

WCK 4282:

Protocol for Global Phase III complicated urinary tract infection (cUTI) study has been discussed and approved by FDA and EMA. Chinese NMPA concurred that product meets unmet medical need and agreed with the clinical development plan and clinical study protocol. The study is estimated to commence by Q1 2021.

WCK 4873:

Obtained Indian regulator DCGI‘s approval for initiating Phase 3 study in India for the indication of community acquired pneumonia. Discussion with ANVISA completed on the study protocol. Similar approval is being sought from Mexico. Phase III study in India and LATAM is estimated to commence in second half of 2020.

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. DCGI approvals have been received for manufacturing and marketing in India for both WCK 771 & WCK 2349 which represents the first ever India discovered antibiotics receiving approval. Both the drugs have been approved for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including diabetic foot infections and concurrent bacteraemia.

WCK 6777:

US IND has been _led in US and phase I studies scheduled to commence by end of 2020 in US. All the above NCEs, have distinction of QIDP status by US FDA.

Your Company has strong focus in developing intellectual property and _led 93 patents during the year under review. 66 patents out of 93 patents pertain to NCEs. During the year 60 patents were granted of which 58 patents were for NCEs. Thus, year after year a high success rate for the grant of NCE patents is maintained. As on 31st March, 2020, combined pool of Companys patent has reached 3,165 _lings and 722 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 _eld. 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. Biotechnology R&D team of the Company 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.

Your Company has 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. Pharmacokinetic and Pharmacodynamic (PK/PD) study for Insulin Aspart is estimated to commence in Q3, 2020. Your Company, during the year, has received approval from RCGM, Department of Biotechnology, Govt. of India for preclinical study report of Recombinant Darbepoetin and PK/PD study is expected to be initiated in 2021.

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 o_ers opportunity with surmountable challenge to replicate the same for other insulin analogues.

Biobetters:

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. Preclinical study for one of the Insulin/Insulin Analogue biobetter drug product is planned to be initiated in 2020.

COMPANY OUTLOOK

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 efforts to enhance its reach in emerging markets.

d. Increasing pipeline of niche & complex technology generic products

SEGMENT-WISE PERFORMANCE

The Company is exclusively into pharmaceutical business segment.

DETAILS OF RATIOS

a) Interest coverage ratio : 0.59 to 0.99 - Favourable
b) Operating Profit margin : 3% to 7% - Favourable
c) Net Profit margin : (5%) to (1%) - Favourable
d) Return on Networth : (7%) to (1%) - Favourable
e) Debtors turnover ratio : 3.3% to 2.3% - Favourable
f) Inventory Turnover ratio : 2.1% to 1.7% - Adverse
g) Current Ratio : 2.13 to 1.41 - Adverse

There was a positive increase in the ratios such as Interest coverage, Operating Profit margin and net Profit margin and significant improvement in EBITDA. Return on Networth has improved mainly on account of re-alignment of top-line across businesses in favour of high margin portfolios along with significant cost rationalisation and cost containment measures to improve the overall e_ciency and operational hygiene.

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-de_ned policies, guidelines and authorizations and approval procedures. Internal audits are performed to test the adequacy and effectiveness 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.

HUMAN RESOURCES

Wockhardts talent base, as on March 31, 2020 stands at 5,106.

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 Efficient.

At Wockhardt, ‘Life Wins is a simple yet profound theme that defines our efforts, reflect our goals, highlights our aspirations 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 BEST ONBOARDING AWARD 2019 as a Winner by People Matters in across Industries.

‘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 o_ers a unique combination of our core values and functional proficiency.

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 held associates, ‘Emerge, ‘Surge and ‘Upsurge which provides career visibility to development to our sales force.

Using PI has helped companys understanding of employees, potential strengths and particular characteristics. In this program, the associates are mapped 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.

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 affect 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