Cadila Healthcare : Annual Report (2020-2021)

Cadila Healthcare Ltd.

I N N O V AT I O N T H AT S A V E S L I V E S

AnnualReport2020-21

CORPORATE INFORMATION

Founder

Late Ramanbhai B. Patel

Board of Directors

Pankaj R. Patel

Chairman

Dr. Sharvil P. Patel

Managing Director

Ganesh N. Nayak

Executive Director

Mukesh M. Patel

Non-Executive Director

Bhadresh K. Shah

Independent Director

Nitin R. Desai

Independent Director

Dharmishtaben N. Raval

Independent Woman Director

Apurva S. Diwanji

Independent Director

Nitin D. Parekh

Chief Financial Officer

Dhaval N. Soni

Company Secretary

COMMITTEES OF THE BOARD AND THEIR CONSTITUTION:

Audit Committee:

Mr. Nitin R. Desai, Chairperson

Mr. Apurva S. Diwanji

Ms. Dharmishtaben N. Raval Mr. Bhadresh K. Shah

Mr. Mukesh M. Patel

Nomination and Remuneration Committee:

Mr. Nitin R. Desai,

Chairperson

Mr. Pankaj R. Patel

Mr. Apurva S. Diwanji

Ms. Dharmishtaben N. Raval

Mr. Bhadresh K. Shah

Mr. Mukesh M. Patel

Corporate Social Responsibility Committee:

Mr. Pankaj R. Patel,

Chairperson

Dr. Sharvil P. Patel

Ms. Dharmishtaben N. Raval

Risk Management

Committee:

Mr. Pankaj R. Patel,

Chairperson

Dr. Sharvil P. Patel

Mr. Apurva S. Diwanji

Mr. Mukesh M. Patel

Mr. Nitin D. Parekh

Stakeholders' / Investors' Relationship Committee:

Mr. Mukesh M. Patel,

Chairperson

Mr. Pankaj R. Patel

Dr. Sharvil P. Patel

Mr. Bhadresh K. Shah

Share Transfer Committee:

Mr. Pankaj R. Patel,

Chairperson

Dr. Sharvil P. Patel

Mr. Mukesh M. Patel

Finance and Administration Committee:

Mr. Pankaj R. Patel,

Chairperson

Dr. Sharvil P. Patel

Mr. Ganesh N. Nayak

Statutory Auditors

Deloitte Haskins and Sells LLP

Chartered Accountants

Ahmedabad

Zydus Research Centre

Survey No. 396/403,

Sarkhej-Bavla N.H. No. 8A,

Moraiya, Ahmedabad - 382 213

Pharmaceutical Technology Centre (PTC):

Plot No. A-106, 107, Road Number

21, Nehru Nagar,

Wagle Industrial Estate,

Thane West, Thane-400604

Maharashtra

Registrar and

Share Transfer Agents

Link Intime India Private Limited,

506-508, Amarnath Business

Centre-1(ABC-1),

Besides Gala Business Centre,

Off. C G Road, Ellisbridge,

Ahmedabad - 380 006

Formulation Units

Plot No. 1, 1A, 1B and 2,

'PHARMEZ' (Special Economic Zone),

Matoda, Sarkhej-Bavla N.H. No. 8A,

Taluka: Sanand,

District: Ahmedabad - 382 213

Survey No. 417, 419 & 420,

Sarkhej-Bavla N.H. No. 8A,

Village: Moraiya,

Taluka: Sanand,

District: Ahmedabad - 382 210

Survey No. 434/6/B and 434/1/K,

Village Jarol, Taluka: Waghodia,

Vadodara - 391510

Plot No. 254-255,

S.G. Highway N.H. No. 8A,

Changodar, Taluka: Sanand,

Ahmedabad - 382210

Plot No. 203-213,

Kundaim Industrial Estate,

Ponda, Goa - 403 115

Village: Swaraj Majra, Baddi

District: Solan

Himachal Pradesh - 173 205

API Units

Block No. 265/266,

Village: Changodar,

Sarkhej-Bavla, N.H. No. 8A,

Ahmedabad - 382 210

GIDC Estate,

Ankleshwar 393 002, Gujarat

Dabhasa, Taluka: Padra 391 440

District: Vadodara

Block No. 162,

Ekalbara Umraya Road,

Village: Dabhasa,

Taluka: Padra 391 440

District: Vadodara

Biologics Unit

Survey No. 40P, 23, 25P, 42, 37,

Opp. Ramdev Masala,

Sarkhej-Bavla N.H. No. 8A,

Changodar,

District: Ahmedabad - 382 213

Registered and

Corporate Office

Zydus Corporate Park,

Scheme No. 63, Survey No. 536,

Near Vaishnodevi Circle,

Khoraj (Gandhinagar), S.G. Highway,

Ahmedabad - 382481

Forward-looking statement: In this Annual Report, we have disclosed forward- looking information to enable investors to comprehend our prospects and take informed investment decisions. This report and other statements - written and oral - that we periodically make, contain forward- looking statements that set out anticipated results based on the management's plans and assumptions. We have tried wherever possible to identify such statements by using words such as 'anticipates', 'estimates', 'expects', 'projects', 'intends', 'plans', 'believes' and words of similar substance in connection with any discussion on future performance. We cannot guarantee that these forward-looking statements will be realised, although we believe we have been prudent in assumptions. The achievement of results is subject to risks, uncertainties and even inaccurate assumptions. Should known or unknown risks or uncertainties

materialise, or should underlying assumptions prove inaccurate, actual results could vary materially from those anticipated, estimated or projected. We undertake no obligation to publicly update any forward- looking statements, whether as a result of new information, future events or otherwise.

2 | Annual Report 2020-21

Mr. Ramanbhai Patel

Founder Chairman

August 19, 1925 - September 19, 2001

"The world continues to battle one of the worst healthcare challenges seen in the recent decades. COVID-19 is still posing a threat to people's lives in India and across the world. As the healthcare fraternity continues to battle this scourge, we at Zydus have brought hope with our therapies and innovations. In March 2020, we resolved to fight this pandemic in every way that we can, with therapeutics, vaccines and diagnostics. We stood united in this mission with the medical professionals, nurses and other frontline warriors bringing greater purpose to our efforts and ensuring that we live upto our credo of creating healthier communities. A year on, we continue to tread on this path, bridging the unmet medical needs and doing all that we can to alleviate suffering and nurturing good health."

Our Founder Chairman, a seeker, an explorer and innovator, continues to inspire us and forms the founding pillar of the innovation journey at Zydus as we live our mission of creating healthier, happier communities by bridging unmet healthcare needs.

C O N T E N T S

Company Overview	Statutory Reports	Financial Statements
	Management Discussion
Fighting the Pandemic 02	and Analysis 12	Standalone 94
Business Responsibility
Chairman's Message 06	Consolidated 155
Report 47
Highlights of the year 08	Board's Report 53	Notice 225
	Corporate Governance Report 76

Annual Report 2020-21 | 1

LEADING THE FIGHT AGAINST COVID-19

World's first Plasmid DNA vaccine, indigenously developed by Zydus for COVID-19 is awaiting approvals for Emergency Use Authorisation by the DCGI

ZyCoV-D, World's first Plasmid DNA vaccine, to combat the COVID-19 pandemic is awaiting approvals for Emergency Use Authorisation by the DCGI. Fully committed to the 'Atma Nirbhar Bharat' mission, and the largest COVID vaccine trial in India, this vaccine is a tribute to Indian innovation.

The dosing for the Phase III clinical trials was done in over 28,000 healthy volunteers as part of the multicentric, randomised, double- blind, placebo controlled, study. ZyCoV-D has also been tested for the 12-18 years. The vaccine was found to be safe, well tolerated and immunogenic in the Adaptive Phase I/II clinical trials. ZyCoV-D is stable at room temperature & has a long shelf life from 2 to 8 degrees which is ideal for Indian weather condition. This vaccine is a

DNA platform which allows generating new construct quickly to deal with mutations in the virus. It also provides ease of manufacturing with minimal biosafety requirements. The vaccine is intradermal and painless as it is used with a needle-free applicator, Tropis® from the PharmaJet®.

The trial was reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.

Zydus explores monoclonal antibodies cocktail to neutralise COVID infection

Zydus seeks DCGI approval to undertake clinical trials for ZRC-3308 (Covimabs), a cocktail of two anti-SARS-CoV-2 monoclonal antibodies to combat COVID-19.ZRC-3308 can emerge as one of the main treatments for mild COVID-19.SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody based treatments have received emergency use authorization in mild COVID-19 in the US, Europe and in India because they significantly reduced viral load in mild patients and their rate of hospitalization.

Two of these products are cocktail based products comprising of two mAbs binding to two different epitopes on the spike protein of SARS-CoV-2 virus. Cocktail of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants. Zydus is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of COVID-19.

2 | Annual Report 2020-21

COMPANY OVERVIEW		STATUTORY REPORTS	FINANCIAL STATEMENTS

Zydus launches 'Virafin' for Treating

Moderate Covid Patients

Zydus launched Virafin (Pegylated Interferon alpha- 2b) for treating moderate COVID infection in adults. A single dose of the antiviral Virafin administered subcutaneously early on shows significant clinical and virological improvement in moderate COVID-19 adult patients. 91.5% of patients treated with Peg IFN were RT PCR negative by day 7. The treatment significantly reduces the hours of supplemental oxygen in the patients.

In the multicentric trial conducted in 20-25 centers across India, Virafin had shown lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19. The drug has also shown efficacy against other viral infections.

Zydus markets Liposomal Amphotericin B, A Critical Drug to Treat Black Fungus Or Mucormycosis In India

Zydus and TLC of Taiwan, signed a license, supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) in India. AmphoTLC™ is a critical drug to treat Mucormycosis or Black Fungus in India.

The Central Drugs Standard Control Organization (CDSCO) of India has approved the New Drug Application (NDA) of TLC for Amphotericin

B Liposome for Injection 50mg or AmphoTLC™ for immediate importation as per approved usage and indication. AmphoTLC™ is the first and only complex generic drug to have achieved bioequivalence to Gilead's AmBisome, proving its sameness to the safest form of amphotericin B in the world.

Zydus Launched Viroshield

Mouth Spray

Zydus launched Viroshield mouth spray. Viroshield is a unique scientifically tested enzyme based formulation. It provides protection and safety against the coronavirus. The spray is an easy to use mouth spray wherein one needs to puff it twice in the throat area, which forms a protective layer on the mucous membrane in the throat to prevent the viruses from infecting the cells in the throat which reduces the viral load. This mouth spray can be used by children who are above four years of age.

Remdac is the most affordable Remdesivir at Rs. 899

Zydus makes Remdac, its brand of Remdesivir more affordable at Rs. 899 for a 100 mg lyophilized injection. The critical drug even at the time of its launch was the most economical brand of Remdesivir. The price cut made it further affordable for the patients.

Annual Report 2020-21 | 3