Panacea Biotec Ltd Management Discussions.

INDUSTRY STRUCTURE & DEVELOPMENTS

Global Vaccine Market

Vaccination is one of the most important health interventions introduced globally, providing a cost-e ective way of Profitecting infants, children and the population at large from a range of serious illnesses and debilitating complications associated with vaccine-preventable diseases. According to UNICEF, immunization programs have helped in saving more than ove lives every minute preventing up to 3 million deaths a year. Immunization has largely reduced the incidence of diseases like measles, polio, small pox etc. Global vaccine market is estimated to be around US$ 30 billion in 2020 of which self-procuring high-income countries (HIC), middle-income countries (MIC) and private market vaccines account for US$ 25 billion (85% of the market) and vaccine supply for public immunization contributes to US$ 5 billion (WHO Global Vaccine Market Report 2019). While HICs and few MICs are able to meet their domestic demand of vaccines, a large number of low and middle income countries (LMICs) rely on a ordable vaccines supplied by United Nations Children Fund (UNICEF) and Pan American Health Organization (PAHO).

Indian Vaccine Market

India is the vaccine manufacturing epicenter of the world with more than 80% of the volume demand for domestic and international markets being served by few Indian manufacturers. The Indian vaccine industry has been instrumental not only in facilitating cost-e ective vaccination in India, but also supplying vaccines to majority of the developing and underdeveloped world. The size of the Indian vaccine industry is approximately US$ 1.45 billion in 2020, projected to grow to US$ 2.9 billion by 2025 at a CAGR of approximately 15%. The Indian vaccine market has registered signiocant growth in recent years due to several factors including technical advancements, improved storage facilities with cold chain maintenance, increased production capacity, increased government support in research and development through different agencies and increasing awareness among the consumers.

The vaccine industry has a high entry barrier owing to high research intricacy, sophisticated scientioc know-how and capital-intensive manufacturing capacity creation.

Private vaccine market in India is valued at US$ 300 million. Private vaccination currently has a small coverage, accounting for only 10-15% of the total volume but substantially higher price realization in the private market make it an attractive segment for vaccine companies. Private vaccination coverage is also growing in line with rising disposable income of the middle-class and awareness on preventive health measures. Vaccine exports from India was around US$ 760 million in 2020. Indian vaccine companies export vaccines to more than 150 countries. According to GAVI data, India accounted for a dominant 60% of their vaccine volume supply in 2020.

Global Pharmaceutical Market

The global pharmaceutical market scaled US$ 1,265 billion in 2020 and is expected to touch US$ 1,600 billion by 2025 (Source: IQVIA (2021), Global Medicine Spending and Usage Trends). The overall market is expected to grow at a pace of 3-6% through 2025 with the relatively mature North American and European markets growing at 0-3% and 3-5% respectively and emerging markets at 7-10%. North America contributed nearly 50% to the total market and Europe 23.9%. The industry contributed US$ 532 billion directly to global GDP in 2017. It has created 5.5 million jobs directly and supported additional 45 million jobs along the supply chain, in the same year (Source: WifOR (2020), The Global Economic Impact of Pharmaceutical Industry).

WHO reported a continuous rise of global spending on health during time period 2000 and 2018, with spending in 2018 touching US$ 8.3 trillion, nearly 10% of global GDP (WHO: Global Spending on Health: Weathering the storm, 2020). Despite Covid-19 led subdued growth in 2020 and 2021, it is expected that in 2021, the global medicine spending will touch US$ 1,331 billion. The mid-term outlook outlines optimism with global spending expected to soon revert to pre-Covid levels. Rising Pharmaceutical R&D Expenditure Potential to Drive Growth of Market: Past decade has witnessed multifold increase in pharma R&D expenditure globally. In 2019, total pharmaceutical R&D expenditure was estimated to exceed US$ 83 billion in US (Source: Congressional Budget O ce, 2021) and EUR 37 billion in Europe. The expanding capital pool for R&D investment in US has also led to 60% increase in number of new drugs approvals from 2010 to 2019, with a record number of 59 approvals in 2018.

Indian Pharmaceutical Market

Indian pharmaceutical industry is estimated to account for 3% to 3.5% of the global pharmaceutical industry in terms of value at US$ 44.6 billion. India is self-su cient in drug formulations; and the industry is spurred by both - a high growth domestic market as well as dominant presence in global pharmaceutical exports. As of year ended March 2021, Indian industrys pharmaceutical exports scaled to US$ 24.4 billion. During the same period, the domestic pharmaceutical market breached US$ 20.2 billion. Globally, the industry is ranked third in terms of volume share and fourteenth in terms of value share. Being a heavily generics oriented industry, the volume share is higher compared to value share. Drug formulations and biologicals make the highest contribution (77%) in the pharmaceutical exports from India and has also registered the highest YoY growth amongst all categories. Growth of the segment has been driven by Indias strong foothold in the global generics and vaccines supply - India is the largest supplier of generic medicines globally (20 to 22% of the global export volume) and also the largest supplier of vaccines for global public health supply. Geographically, North America is a major export market for India, with USA contributing to 95% of export business. India

India, with USA contributing to 95% contributes to 40% of the demand of generic medicines in the USA. Tailing North America, Africa is the second largest region for pharmaceutical exports, with South Africa contributing 17% to the regions demand. In FY21, exports to Africa grew by 13.4% as against 2.2% growth during previous scal year FY20. Exports to Europe also grew by 11% as compared to 4.56% during the previous scal year. Non-traditional markets such as Latin America, Middle East etc. have also emerged as important export destinations and Indian suppliers have been able to increase their foothold in these geographies. Indian export business outpaces global pharma growth: Indian pharmaceutical companies exhibited great resilience during the pandemic year and contributed towards record export gur es, despite headwinds during the pandemic in the form of lockdowns and supply chain disruptions. Overall, Indian pharma industrys outlook for sustained growth in exports stays strong due to fundamental drivers including R&D strength, quality consciousness and cost competitiveness.

Production Linked Incentive Scheme: In a bid to counter the persistent business threat of low priced Chinese imports, the Government has introduced the Production Linked Incentive Scheme (PLI) for domestic manufacture of several active pharmaceutical ingredients (APIs) where import dependence is a threat to access to essential drugs as well as certain Key Starting Material (KSMs) and Drug Intermediates (DIs). With an overall outlay of US$ 920 million, the scheme hopes to provide production linked incentives of 5% to 20% on revenue for the stipulated drugs including vaccines.

On account of Covid-19 pandemic, the Indian Pharmaceutical Market (IPM) saw a modest growth rate of only 2% between March 2020 and March 2021. However, the overall mid-term outlook remains buoyant driven by several drivers for market expansion. The IPM will continue beneoting from combination of factors such as rising income levels with steady economic growth, shift in disease proles and increasing burden of chronic diseases, improvements in healthcare infrastructure, improving access of healthcare in the hinterlands of the country, new launches by innovator companies and rapid healthcare digitalization across the country.

Impact of Covid-19 pandemic

Globally, Covid-19 led to an economic slowdown impacting most industries. Direct short-term impact of Covid-19 was seen in pharmaceutical supply chains globally which were affected due to travel restrictions. Delays and temporary halts were observed in clinical development pipeline of pharma majors globally and subsequent delay in regulatory approvals as the agencies were preoccupied with regulatory review of Covid-related medications and vaccines. Nation-wide lockdowns impacted the movement of people to hospitals and access to clinical services and the spill-over effect was seen in the dip in sales of hospital-administered medications and acute medicines. However, with most countries returning to normalcy now, the sector has bounced back, new regulatory approvals have picked-up pace. Illustratively, new drug approvals by the US FDA from January to June 2021 were at an all-time high of 30 vs 25 approvals for the same period in 2020 and 13 in 2019 for the same period. On the Indian front, pharmaceutical exports were not affected by Covid-19 and increased by 18.07% in FY 2020-21 from previous scal year. In the domestic pharmaceutical market, growth was modest at only 2% YoY compared to previous years growth of 6%, however, long-term outlook remains positive as multiple growth drivers propel the segment. Immediate impact of Covid-19 and other geopolitical factors has been the governments and industrys focus on attaining self-su ciency in API production and making the supply chains more resilient by reducing dependence on imports. Overall, the industry is poised for growth led by improving access to healthcare and more focus on preventive healthcare.

PANACEA BIOTEC BUSINESS SEGMENTS

VACCINES BUSINESS

Panacea Biotec continues its focus on vaccines as a core therapy segment and believes in its purpose of rendering long term Profitection from preventable diseases. The Company has pioneered in the development of wholecell pertussis ("wP") based fully liquid combination vaccines and has launched worlds first fully liquid wP-IPV based hexavalent vaccine TM

EasySix (Diphtheria, Tetanus, Wholecell Pertussis,

Hepatitis B, Hib and IPV) in India in March 2017.

The Companys product portfolio includes key proprietary vaccines that include, the worlds first fully-liquid wP based hexavalent vaccine (DTwP-HepB-Hib-IPV) branded as

TM

EasySix , fully liquid tetravalent vaccine (DTwP-Hib) branded as EasyfourR-TT and WHO prequalioed fully-liquid pentavalent vaccine (DTwP-HepB-Hib) branded as Easyv e-TTR and Bivalent Poliomyelitis Vaccine (Type 1 & 3), Live (Oral) branded as Bi-OPVR etc.

Panacea Biotec is a leading manufacturer of pediatric vaccines and has played a pivotal role in eradication of polio disease from India and many other countries, being one of the largest suppliers of oral polio vaccines to UNICEF, the Government of India and other developing countries. In the last two decades, the Company has supplied vaccines for more than 10 billion polio immunizations in developing countries and supplied vaccines for more than 150 million immunizations by fully liquid wP based combination vaccines.

During the year, the revenues from vaccines business has increased to Rs.2,278.34 million from Rs.1,404.15 million in financial year 2019-20, registering a growth of over 60%.

As a part of the long-term growth strategy, the Company is now TM expanding its sales of hexavalent vaccine EasySix in India and has initiated registrations thereof in international markets with having received marketing authorization in two countries. Panacea Biotec is in the process of developing new generation vaccines like Pneumococcal Conjugate Vaccine - NucoVacR, Recombinant Tetravalent Dengue Candidate Vaccine - DengiALLR and Typhoid Conjugate Vaccine. Other vaccines which are in the pipeline include Sabin Inactivated Polio vaccine (sIPV), Tetanus and Diphtheria vaccine, Varicella vaccine and fully indigenous wP based pentavalent vaccine. During the year under review, the Company has successfully completed the Phase I/II study to evaluate the safety and immunogenicity of DengiALLR, a single-dose live-attenuated tetravalent dengue vaccine candidate, which aims to reduce the impact of dengue fever, especially in the endemic regions. The Company has also successfully completed Phase I study to evaluate the safety and immunogenicity of its Pneumococcal Conjugate Vaccine candidate, NucoVacR and has applied for Phase II/III clinical trials.

Domestic Vaccines Business

The Companys domestic vaccine business is managed by Panacea Vaccines SBU. It has registered a strong YoY growth of 25% and has consistently consolidated its position in Vaccine therapeutic category since last three years.

Panacea Biotec continues to Profitect thousands of infants across India from diseases that could otherwise be life threatening. The SBU regularly reaches to nearly 10,000 pediatricians across India with a eld force strength of around 150. Panacea Vaccines SBU rose up to the challenge of

Covid-19 lockdowns and adapted to digital platforms through its innovative customer connect programs like web-Pedagogy which is an online CME platform conducted on Microsoft Teams and preserved in Facebook. Since its launch, the program has become well known, for the in-depth scientic discussion by leading experts, among pediatricians across country. The Panacea Vaccines SBU also brought the top pediatricians on its digital advisory platform where its future roadmap was discussed. The SBU also launched digital / social media outreach to parents via its Facebook page "Vaccine-Immunity". These innovations have helped Vaccines business to outperform in the therapeutic category. The Companys TM innovative vaccine brand EasySix is one of the most consistent successes for Panacea Biotec in the Indian Vaccine Industry.

The other key brands in the SBUs brand portfolio are Easyv e-TTR and EasyfourR-TT. Panacea Vaccines SBU is the only vaccine SBU which has the wP based fully liquid tetravalent, pentavalent & hexavalent vaccines in India and with its wide customer reach and close ties, it is well poised to introduce new vaccines in primary series.

International Vaccines Business

Panacea Biotec supplies its vaccines to UNICEF, PAHO & other governments of several countries and also plans to sell its vaccines in the private market through tie-ups with established industry players in various countries. The Company has registered its vaccines in around 12 countries with further registrations in around 9 countries expected in the near future. The Company is targeting to enter emerging markets with sizeable birth cohort (3-5 mn) to expand its vaccine business.

Panacea Biotec is supporting global cause of providing a ordable vaccines to the children across the globe. The Company is a member of Developing Countries Vaccine Manufacturers Network (DCVMN), a public health driven international alliance of manufacturers and shares common vision and mission of combating infectious diseases and accelerating access to a ordable high-quality vaccines.

PHARMACEUTICAL FORMULATIONS BUSINESS

Panacea Biotec has an established business of pharmaceutical formulations in India and exports its products to over 30 countries worldwide including the United States, Germany, Russian Federation, Turkey, Bosnia, Tanzania, Kenya, Serbia, Vietnam, Philippines, Sri Lanka, Panama, Ecuador, Trinidad & Tobago, etc.

During the onancial year 2019-20, the Company has transferred its pharmaceutical formulations business including pharmaceutical formulations facility at Baddi and related research & development and natural products extraction activities at Lalru, to its wholly owned subsidiary viz. Panacea Biotec Pharma Limited ("Panacea Biotec Pharma" or "PBPL") by way of slump sale on going concern basis with effect from February 1, 2020. The process of getting the product registration / marketing authorisation with respect to the international business transferred to Panacea Biotec Pharma has largely been completed.

Domestic Pharmaceutical Business

Panacea Biotec Pharma has leading brands in a number of therapeutic areas such as Organ Transplantation, Diabetes Management, Pain, Cough & Cold Management and Gastroenterology and has a signiocant presence in Osteoporosis and Oncology therapies in Indian Pharmaceutical Market.

Panacea Biotec Pharma has attained 10 position in its represented Therapeutic Market and is also amongst the Top 65 Pharmaceutical Companies catering Indian Pharmaceutical Market as per the AIOCD AWACS (MAT March 2021) sales data.

During the year, performance was boosted by continued product supply and high performance of key brands. For the coming year, Panacea Biotec Pharma has taken more strategic initiatives for all SBUs and expects further improved performance in the business.

The pharmaceutical formulations business in India has been structured among 4 Strategic Business Units (SBUs) - 2 SBUs for Super-Specialty Business as Transplantation & Immunology and OncoTrust whereas other 2 SBUs for Acute & Chronic Care Business namely Diacar Alpha and Procare. As per AIOCD AWACS (MAT March 2021) sales data, therapeutic category wise market share in respective represented market and sales in Indian market including vaccines is graphically represented below:

Panacea Biotec Pharmas leading brands are well recognized and respected by the medical fraternity and command signiocant market share in their respective represented market. As per the AIOCD AWACS (MAT March 2021) Sales Data, the Companys top selling brands viz., PanGrafR, AlphadolR, CilaminR and LivolukR Fibre were ranked number 1 whereas GlizidR, Glizid-MR, Glizid-MVR, MyceptR, Mycept-SR, SitcomR, KONDROR and NimulidR were amongst the top 5 brands in their respective markets.

As per the AIOCD AWACS (MAT March 2021) sales data, Panacea Biotec Pharmas rank in respective therapeutic category represented markets in India is as follows:

Therapeutic Category Rank in CVM
PBPL Rank in RPM 10
Transplant 1
Anti-Diabetic 15
Gastro Intestinal 14
Pain / Analgesics 13
Oncology 12

The revenues were well balanced between acute and chronic therapies. Key brands across these therapies continued to perform in the market and many of the brands maintained leading position in their respective markets. The Brands rank in respective therapeutic category in the covered market is as follows:

Brand Covered Market (CVM) Brand Rank in CVM
PanGrafR Tacrolimus 1
AlphadolR Alfacalcidol 1
CilaminR Penicillamine 1
LivolukR Fibre Lactulose + Ispaghula 1
MyceptR Mycophenolate Mofetil 2
SitcomR Tab Varicose Therapy, Systemic (Haemorrhoids/ Piles management) 2
SitcomR LD Topical Anti-Haemorrhoidals 2
Cream Without Corticosteroids (Haemorrhoids/ Piles management)
NimulidR-MD Nimesulide 3
Glizid-MR Gliclazide + Metformin 3
Mycept-SR Mycophenolate Mofetil 3
Glizid-MVR Voglibose + Metformin + 3
Gliclazide
NimulidR Nimesulide 4
GlizidR Gliclazide 5
KONDROR Glucosamine 5

Transplant & Immunology SBU

Worldwide, India is second only to United States in terms of number of transplant surgeries being performed every year, however it still lags far behind the western nations like Spain (46.9 per million population (pmp)) and United States (31.96 pmp) in national donation with a donation rate of only 0.86 pmp (2020) of its huge population. According to the World Health Organization, only around 0.01 percent of people in India donate their organs after death. It is estimated that there is a need of approx. 200,000 kidneys, 50,000 livers and 50,000 hearts for transplantation per year whereas only 7,000 people undergo kidney transplant, 1,100 undergo a liver transplant and only 100 undergo heart transplant (Pre-Covid-19 scenario in 2019), which has further reduced signicantly in 2020 due to Covid-19 situation.

Transplant & Immunology SBU has been supporting Transplant Recipients with a goal to enhance awareness for deceased organ donation in the society. The product portfolio comprises immune-suppressive products that help improve the quality of life of patients who have undergone organ transplantation, primarily kidney, liver or heart transplants. The Transplant SBU has been supporting the clinicians and the patients from last 28 years and over 35,000 patients are successfully consuming the Companys high quality brands. In view of the Covid-19 pandemic situation, where patients are increasingly found it di cult to access the essential lifesaving medicines, Transplant SBU took a number of initiatives in 2020-21 as under:

Launch of 24X7 helpline number with multi-lingual capabilities to support the patients with doorstep delivery of essential medicines. Helpline number was extensively promoted through newspaper advertisements and electronic media.

Doctor connect activities through Live Webinars in collaboration with leading associations.

Patient connect activities, digital marketing initiatives on social media through dedicated facebook page

Transplant Care Helpline.

Increase in retail availability by creating a dedicated network of ~700 channel partners.

Putting the patients interest rst, MyceptR, Mycept-SR &

TM

VagaCyte were made more a ordable and accessible to the patients.

The key brands under this SBU are PanGrafR (tacrolimus), Panimun BioralR (cyclosporine), MyceptR (mycophenolate mofetil), Mycept-SR (mycophenolate sodium), AlphadolR (alfacalcidol). The main brands of the SBU viz. PanGrafR & AlphadolR continue to maintain leadership position in their respective covered markets, as per the AIOCD AWACS (MAT March 2021) sales data. PanGrafR has maintained its leadership position in Tacrolimus market in India since more than a decade with around 66% market share as per AIOCD AWACS (MAT March 2021) sales data, while in the Mycophenolate market, MyceptR & Mycept-SR have been ranked as number-2 and number-3 brand respectively. AlphadolR is the leading brand in the Alfacalcidol market with 92% market share as per AIOCD AWACS (MAT March 2021) sales data. Transplant SBU has launched MyceptR Suspension (mycophenolate mofetil oral suspension) in August, 2019 which has further strengthened the immuno-suppressant portfolio.

The transplant and immunology SBU is the highest contributor to revenues from domestic pharmaceutical formulations business, with 35% of net domestic pharmaceutical formulations revenues being generated by this SBU in scal 2021.

OncoTrust SBU

This SBU is dedicated towards cancer related pharmaceutical products and through this SBU, Panacea Biotec seeks to provide products that provide cancer patients with a ordable and quality chemotherapy and cancer management. As on March 31, 2021, this SBU has 15 products for lung, breast and colorectal cancers, as well as gliomas, haematomas and for supportive care. Panacea Biotec was the orst Indian Company to launch PacliALLR a brand of Nab-Paclitaxel, for the management of Breast Cancer. Breast cancer is the leading cause of cancer-associated mortality in women worldwide. It has grown disproportionately in incidence within the developing world, especially in countries with low socio-demographic index. Breast cancer has become the top ranked cancer in India with age-adjusted incidence rate of 25.8 per 100,000 women. PacliALLR (nab-paclitaxel) is a novel drug delivery system that also circumvents the need of premedication with steroids to prevent hypersensitivity reactions. Treatment with PacliALLR (nab-paclitaxel) during clinical trials has resulted in excellent outcomes among patients with MBC, and in signiocant e cacy in heavily pretreated, taxane-refractory MBC patients. PacliALLR, the oagship brand of the Company, which was awarded with Brand of the Year Award 2011 by Bio-Spectrum (Now Clarivate Analytics), continues to be No.1 brand in nab-paclitaxel market and has saved the lives of more than 14,000 patients till now, and is one of the most admired brands for the treatment of breast cancer.

During the current year i.e. FY 2021-22, PacliALLR has completed a decade of Evidence, Excellence and Experience in passing benets to patients.

The other major brands of the SBU include AZAFABR (azacitidine), BorteTrustR (bortezomib), DoceTrustR (docetaxel trihydrate), PexeTrustR (pemetrexed disodium), GemTrustR (gemcitabine hydrochloride) and other cytotoxic injections. During the year under review, Panacea Biotec has launched,

Dasatinib, a chemotherapy drug sold under the brand name

TM

Dasapan which is a targeted therapy used to treat certain cases of chronic myelogenous leukemia & acute lymphoblastic leukemia and Sunitinib, sold under brand name TunibR, an oral, small molecule, multi-targeted Receptor Tyrosine Kinase. With the launch of TunibR, for the first time, the Company has entered into a new therapy area of Renal Cell Carcinoma, with a vision to become the most preferred partner for accessible & better care for the patients.

Diacar Alpha SBU

The Indian Diabetes Market is valued at around Rs.149.3 billion as per AIOCD AWACS MAT March 2021. India is home to an estimated 77 million diabetics, making it the second most affected country in the world after China. International Diabetes Federation (IDF) estimates Indian diabetics population to increase to 134 million over the next 25 years. The growing burden of Diabetes makes it one of the most common risk factor for all-cause morbidity & mortality. Diabetes related complications affect the most common vital organs like Heart, Brain, Kidneys, Eyes and Nerves. The Diacar Alpha SBU with a dedicated marketing and sales team of more than 330 people, has been focusing on improving the awareness, screening and detection for diabetes & related complications. During the year, Diacar Alpha SBU has conducted more than 450 A1C camps, 9,000 DDC camps & 16,000 OPD camps by touching over 1,00,000 patients through its "SURAKSHA" initiative. This continuous service orientation has given your Company a strong foothold in the er cely competitive anti-diabetic market. Diacar Alpha SBU focuses on key specialties such as endocrinologists, diabetologists, cardiologists and physicians, to address the high incidence rates of diabetes and hypertension in India and is the second highest revenue contributing SBU, with 33% of net domestic pharmaceutical formulations revenues in Fiscal 2021 being generated by this SBU.

Product range of Diacar Alpha SBU ranges from catering to first line therapy in diabetes management with its brand

TM

Metlong (metformin) to a second line treatment option of a Sulphonyl Urea - GlizidR (gliclazide) and DPP4 - inhibitors - ViLACT (vildagliptin), TENEPAN (teneligliptin) along with supportive therapies in management of Diabetic Neuropathy with its MyelogenR range. The Diacar Alpha SBU stands strong and committed to provide quality life years to the diabetic population. SBU recently launched DapaBestR(dapaglio zine) in this space.

The agship brands of Diacar Alpha SBU, viz. Glizid-MR, GlizidR and Glizid-MVR are amongst top 5 brands in its respective market segment. Recently launched brands ViLACT (vildagliptin) and ViLACT-MR (vildagliptin and metformin) are gaining momentum in the er ce generic market.

Procare SBU

Procare SBU caters to the orthopedic and gastroenterology related chronic care therapies, through focus on specioc disease management. Within orthopaedics, the focus is on osteoporosis, osteoarthritis and rheumatoid arthritis management and within gastroenterology, the focus is on constipation, anorectal disorders, acid-peptic disorders and liver disease management through its established brands and engagement with consulting physicians, orthopedic, gastroenterologists and general surgeons.

The Procare SBU has established its agship brands SitcomR, LivolukR and KONDROR amongst the top 5 brands in their respective represented market as per the AIOCD AWACS (MAT March 2021) sales data.

Apart from agship brand of SitcomR (euphorbia prostrata), SitcomR Forte (euphorbia prostrata and calcium dobesilate), LivolukR (lactulose) and SitcomR-LD Cream, the SBU has anti-inoammatory and muscle relaxant products including WillgoRCR (aceclofenac 200mg SR), WillgoRP (aceclofenac 100mg, paracetamol 325mg), WillgoRTH4 & WillgoRTH8 (aceclofenac and thiocolchicoside) and WillgoRSP (aceclofenac 100mg, serratiopeptidase 15mg as enteric coated granules and paracetamol 325mg) and osteoarthritis range with KONDROROD (glucosamine 1500mg), KONDRORACUTE (glucosamine 1500mg and diacerin 15mg) and KONDRORFLEX (glucosamine 1500mg, collagen peptides 10gm and vitamin c 35mg) intended for pain management in patients su ering with Rheumatoid Arthritis and Arthritis.

International Pharmaceutical Business

Panacea Biotec Pharma exports its pharmaceutical formulations in around 30 countries including the United States, Germany, Russian Federation, Turkey, Bosnia, Tanzania, Kenya, Serbia, Vietnam, Philippines, Sri Lanka, Panama, Ecuador, Trinidad & Tobago etc. It continuously takes steps to strengthen and grow its exports in the coming years including building a strong portfolio, strengthening marketing team, entering into newer markets, identifying strong distributor and marketing partners into newer regions and registering products in more countries as well as strengthening existing relationships with the partners. It has further continued its focus on development, registration and marketing of products portfolio catering to chronic therapies in private markets in several countries. Simultaneously, Panacea Biotec Pharma has consolidated its international pharmaceutical business by eliminating loss making products, markets etc. During the year, the export revenues have grown by 17% to Rs.1,305.92 million from Rs.1,117.14 million during previous financial year, on account of increase in export sales primarily to ICH markets which has grown by 54% as compared to previous financial year.

The Company has entered into a tripartite agreement with Natco Pharma Ltd. and Breckenridge Pharmaceutical Inc., USA for manufacturing and supply of Azacitidine Injection for the US market under Breckenridges already-approved ANDA (the generic equivalent of VidazaR marketed by Celgene Corp, US). The supplemental abbreviated new drug application (sANDA) submitted by Natco as "Prior Approval Supplement" has been approved by the USFDA on May 06, 2019. The Company has received USFDA approval for this product and has launched the same in USA during onancial year 2019-20 through Breckenridge.

The Companys Abbreviated New Drug Application (ANDA) submitted under section 505(j) of the Federal Food, Drug & Cosmetics Act (FD&C Act) for Paclitaxel Profitein bound particles for Injectable Suspension 100mg/vial had been accepted for ling by the USFDA and the approval is in process. In addition, the approval process for other ANDAs led earlier with the USFDA is in progress. Panacea Biotec Pharma plans to launch these products in US, Europe, etc. through strategic collaborations with leading pharmaceutical companies.

Panacea Biotec Pharma continues to focus on building a robust pipeline of several products for ling in several other emerging markets which it will be ling in the next 1-2 years to further strengthen its export portfolio and grow export sales.

Supply Chain Management & Logistics Network

Panacea Biotec has a well-established Supply Chain Management (SCM) system designed for creating end-to-end visibility and controls right from sourcing of materials till collection of receivables for both the pharmaceuticals and vaccines products.

The Company has a strong logistics network comprising of one Central Warehouse and 14 Sales Depots / Carrying & Forwarding Agents (CFAs) (comprising of Vaccine AVDs). Vaccine availability across India is ensured through vast distributor network of around 550 distributors as on March 31, 2021, which enable us to have a pan-India presence and access to a wide market base.

Panacea Biotec Pharma also has a strong logistics network comprising of one Central Warehouse and 23 Sales Depots / CFAs. Product availability across India is ensured through vast distributor network of around 2,200 distributors as on March 31, 2021, which enable us to have a pan-India presence and access to a wide market base.

The Company has got expertise in cold chain management for storage and distribution of vaccines under controlled conditions using a system of Vaccine Vial Monitors (VVMs), data loggers, ice boxes, coolant, cold rooms, refrigerated vehicles and Tyvek sheet for sending temperature controlled products overseas and across India directly from its Vaccine Formulation Facility at Baddi, H.P. This ensures that the Vaccines remain safe and effective against changes in the variant temperature conditions during transit. The SCM team is committed to ensure timely availability of Companys products to its business partners and patients.

Panacea Biotec has a well-established Track and Trace system and documentation quality to ensure that goods reach destination timely and to avoid demurrage and detention charges. Panacea Biotec has optimized raw material, packaging material, onished good inventory to achieve maximum inventory turn and to minimize expiry. The Company collaborated & appointed world class logistics providers with proven record of timely delivery of goods in important markets.

MANUFACTURING FACILITIES

Vaccines Formulation Facility at Baddi

The Companys state-of-the-art manufacturing facilities for vaccine drug substances and drug products, comply with the cGMP practices of the key International regulatory bodies like WHO cGMP standards.

The Vaccine Formulation Facility which started its operations in the year 2008 is comprised of two blocks. The production block is spread over approx. 2,800 M2 construction areas at each floor . The warehouse cum cold storage block measures approx. 3 x 2500 M2.

The facility has two independent formulation suites and three olling lines for manufacturing of bacterial, viral and recombinant Vaccines including live attenuated vaccines in pre-lled syringe (PFS) and multi-dose and single dose vial presentations. The facility also has large lyophilization capacity for lyophilized vaccines in vials. This facility is approved by Indian NRA and is also pre-qualied by WHO for the pentavalent vaccine Easyv e-TTR & Bi-OPVR. There is an additional vial lling line for manufacture of live, attenuated vaccines including oral polio, measles, dengue vaccines, Covid-19 vaccine etc.

The warehouse facility is equipped with cold storage and deep freezer for cold chain maintenance and dispatch management of vaccines.

Quality control laboratories of the facility are equipped with assortment of latest sophisticated analytical equipment for testing of vaccines and input materials to assure quality of the product at each stage of manufacturing.

Drug Substance & Biosimilar facilities at Lalru

The Company has drug substance manufacturing facility which started its operations in the year 2002 with separate blocks for manufacture of recombinant, bacterial and viral vaccine drug substance. An integrated block for vaccines and bio pharmaceuticals is also established which comprises of three independent suites dedicated for manufacture of: a) bacterial vaccines, b) viral vaccines, and c) recombinant e.g. biosimilar molecules on cell culture in both conventional as well as disposable formats.

Recombinant Hepatitis B surface antigen, Haemophilus inouenza type B conjugate (Hib-TT), Diphtheria, Tetanus Toxoids and whole cell Pertussis drug substance are manufactured at these facilities. The facility is also approved by WHO for producing bulk antigen of hepatitis B and Hib used for the manufacture of pentavalent vaccine Easyv e-TTR.

Pharmaceutical Formulations Facility at Baddi

Panacea Biotec Pharmas state-of-the-art pharmaceutical formulations facility at Baddi, Himachal Pradesh became operational in year 2006. The facility is quipped for bilayer tablets, mini-tablets, complex sustained release coatings and delayed release coatings. The facility has received several certiocations and accreditations from international regulatory authorities including USFDA, Agency for Medicinal Products and Medical Devices of Croatia, Federal Service for Surveillance in Healthcare (Russian Federation), Ministry of Health Ukraine, ANVISA (Brazil), SAHPRA (South Africa) etc. Quality is a core guiding factor behind Panacea Biotecs decisions and actions. Panacea Biotec Pharma maintains a harmonized Pharmaceutical Quality System (PQS) that caters to all markets. Some of its pharmaceutical formulation products are routinely supplied to low-income countries under access programs through international agencies such as PAHO.

Panacea Biotec Pharma has dedicated and independent Quality Control facilities in the manufacturing plants comprising of sample preparation with isolator containment, wet lab, lab for atomic absorption spectroscopy, dissolution testing and stability testing as per ICH Guidelines, a packaging-material testing laboratory and a fully self-contained microbiology lab to carry out tests for microbial counts, microbiological assays and assessing environment controls.

Panacea Biotec Pharmas pharmaceutical manufacturing expertise lies in various solid, semi-solid & liquid oral dosage forms and vaccines such as: Oral-solids - conventional tablets / capsules, controlled / delayed release / enteric coated tablets and capsules, tablet in tablet, tablet in capsule, multi layered capsules, hard gelatin / soft gelatin capsules, mouth dissolving / chewable tablets, beads encapsulation, coating (olm, sugar & functional), taste masking and fast-dissolving tablets; Semi-solids - ointments / creams / gels, transdermal drug delivery system; Liquids - suspensions / syrups / solutions.

Oncology Facility at Baddi

Panacea Biotec Pharmas cytotoxic injectable formulation facility at Baddi, Himachal Pradesh, has two lines dedicated for liquid & lyophilized vials as well as pilot scale up batches complying with USFDA, EU and ROW cGMP norms. Cytotoxic facility is equipped for manufacturing conventional and technology based injections e.g. nano-particle and liposomal lyophilized products. This facility has been approved by Indian NRA, USFDA and other regulatory agencies.

RESEARCH & DEVELOPMENT

Panacea Biotec is a progressive, Innovative biotech company with high focus on research & development, manufacturing, marketing operations across pharmaceuticals, vaccines and natural or herbal products. The Company is guided by its vision of "Innovation in Support of Life". Panacea Biotec specialises in complex generics, vaccines, and novel drug delivery platforms to offer higher value and better health outcomes for the patients, governments and overall society.

Panacea Biotecs research and development efforts have been its greatest strength. The areas of research are New Chemical Entities (NCE), New Biological Entities (NBE), Novel Drug Delivery System (NDDS), Novel peptides, human monoclonal antibodies and Vaccines. Its ambitions are backed by distinguished, ultra-modern, state-of-art R&D centres with over 60 scientists with deep roots within the academic community in important clusters in India, USA and Germany among other countries.

Vaccine R&D Center has an excellent portfolio of innovative pediatric vaccines which Profitect children against dreadful diseases. Further to broaden the presence of Panacea Biotec in the market, the Vaccine R&D is developing the new generation vaccines like typhoid conjugate, pneumococcal conjugate and tetravalent dengue vaccine. Other vaccines which are in the pipeline include Sabin Inactivated Polio vaccine (sIPV), Tetanus and Diphtheria vaccine, Varicella vaccine and fully indigenous wP based pentavalent vaccine.

The R&D activities to carry out research in vaccines use advanced genetic engineering, molecular biology, genomics tools, animal cell culture, fermentation, puriocation, serological, thermal stabilization and analytical techniques. The Company believes in its innovative vaccine program that will consistently deliver Next Generation Vaccines to safeguard the future of children and help alleviate poverty across the world.

Panacea Biotecs R&D efforts have resulted in ling over 485 patent applications in over 65 countries including India, which include patent applications pending grant and patent applications which were prosecuted. As of March 31, 2021, the Company has been granted over 460 patents globally (out of which 34 are active) some of which have been transferred to Panacea Biotec Pharma and one of which is oled in the name of Panacea Biotec Pharma. Some of the countries where patents have been granted are USA, Germany, Mexico, Brazil, Australia, South Africa, Japan, Russia, Canada, Ukraine, Korea, etc.

Panacea Biotec continues to focus on Research & Development in various therapeutic areas with a constant focus on developing di cult-to-develop formulations focused on chronic and super specialty therapeutic areas. Panacea Biotec has deep experience in developing innovative drug delivery based products such as NimulidR-MD, NimulidR Transgel, PacliALLR, LivolukR Fibre, ODPEP , WillgoRCR and many other such products that enjoy considerable brand equity amongst physicians.

Panacea Biotecs nanotechnology-based product PacliALLR (Paclitaxel bound in human albumin particles) was launched in 2011. At the time, it was the worlds orst generic for Abraxane, manufactured by Celgene, USA. As a First-to-le product in the USA, PacliALLR demonstrates the Companys ability to handle the most complex generics and deliver a high-quality product in constrained and challenging timelines.

Panacea Biotec has been amongst the first companies to have introduced its own New Chemical Entity in India under the trademark of SitcomR tab and SitcomR cream in the year 2008 and is today amongst the leader brands in India for the treatment of Hemorrhoids.

In the eld of Pharmaceutical research, Panacea Biotec has developed different innovative technologies such as hydro gel based topical drug delivery system of peptides and herbal drugs, solid-solid dispersion for highly variable drugs, Self-emulsifying drug delivery system (SEDDS) and controlled release drug delivery systems in different therapeutic areas.

Clinical Research

Clinical research is a critical function that guides clinical decisions based on facts and scientic data through clinical studies on drugs that can affect the health and well-being of millions of people.

Panacea Biotec continuously undertakes clinical trials (Phase I, Phase II and Phase III) for all its investigational new drug applications as well as bioequivalence studies (as per New Drugs and Clinical Trials Rules 2019) for its innovative and generic product portfolios across both vaccines and pharmaceutical products.

Panacea Biotec has conducted over 150 Pre-clinical trials, over 10 Phase I trials, around 8 Phase II trials, around 103 Phase III trials and BA / BE studies across its novel pharmaceutical and vaccine portfolio. As part of its commitment to patient well-being, the Company regularly conducts Post Marketing Surveillance studies. In vaccine business clinical trials, DengiALLR Phase I/II Studies & 11 Valent Pneumococcal Vaccine (NucoVacR) Phase I Studies have been successfully completed.

Intellectual Property

Panacea Biotec has a strong portfolio of intellectual property in the form of patents, trademarks and copyrights in both vaccines and pharmaceutical formulations business. As of March 31, 2021, Panacea Biotec has led over 485 patent applications in over 65 countries including India, which include patent applications pending grant and patent applications which were prosecuted. As of March 31, 2021, the Company has been granted over 460 patents globally (out of which 34 are active) some of which have been transferred to Panacea Biotec Pharma and one of which is led in the name of Panacea Biotec Pharma. Some of the countries where patents have been granted are USA, Germany, Mexico, Brazil, Australia, South Africa, Japan, Russia, Canada, Ukraine, Korea, etc.

Panacea Biotec Group has led 880 trademark applications for registrations, out of which 283 have been registered in India and 253 have been registered outside India as on March 31, 2021, some of which have been transferred to Panacea Biotec Pharma. Further, Panacea Biotec Group has 167 registered copyrights as on March 31, 2021.

As on March 31, 2021, Panacea Biotec Pharma has led 160 trademark applications for registrations, out of which 100 have been registered in India (13 are pending for registration in India) and 42 have been registered outside India (5 are pending for registration in international markets) as on that date. Further, Panacea Biotec Pharma has 49 registered copyrights as on March 31, 2021.

Human Resources

The Company thrives to provide a long and rewarding career to its talented and diverse workforce and focuses on their all-round development and growth. At Panacea Biotec, employees are the core strength of its continuous growth in all the segments. The Company believes that its employees are pivotal to all the initiatives that drive the growth of the business. The Company continues to invest in creation of a work culture representing a unique mix of its values and functional expertise and employees are partner to achieve Vision of the Company. As on March 31, 2021, Panacea Biotec and PBPL has a total manpower of around 2,895 employees (including around 422 through contractors), of which over 2,256 are skilled employees including corporate and managerial sta , sales sta and sta located at its manufacturing facilities. There are over 80 R&D professionals including over 60 scientists engaged in R&D centers, around 793 employees are engaged in production, quality control and quality assurance and around 1,000 employees engaged in sales & marketing and logistics and around 618 in other functions. Further, out of the total employees, around 1,698 employees (including around 238 through contractors) are the employees of Panacea Biotec Pharma.

Panacea Biotec provides meaningful opportunities for learning and growth and continuously encourage its employees to widen the horizon for professional growth. Panacea Biotec provides opportunities for employees to multi-skill and multi-task. Panacea Biotec strongly believes in developing and grooming leaders from within the organization. Panacea Biotecs endeavour has been to create a culture of high performance where people continue to push boundaries of growth and self-development.

Panacea Biotecs Human Resources team aims to become progressive and employee centric and continues to proactively drive and implement various initiatives such as vertical and horizontal promotional opportunities, internal talent development and management, investing in key talent and helping them pursue additional learnings in an attempt to make them more rounded individuals, corporate ethics training across all the functions and many other such initiatives. The Human Resources team continuously utilizes data analytics to develop internal talent, undertake proactive approach towards hiring talented people in selective critical functional areas aligned with Panacea Biotecs growth ambitions.

Strategic partnerships and collaborations

Panacea Biotec has established relationships with various key business associates, including institutional customers for its products, strategic partners for entry into new international markets and domestic & international distributors who distribute its products across the world. Panacea Biotec has a long-standing relationship with the UNICEF and the Government of India, which has helped in participating in immunization programs in India and globally. Panacea Biotecs collaborations has enabled it in developing innovative, cost effective and quality vaccines and helped in achieving its goal of providing cost-e ective vaccines to the global population. Panacea Biotecs collaborations include its collaboration with Limited Liability Company "Human Vaccine" ("HV") (an indirect subsidiary of the Joint Stock Company, Management Company of Russian Direct Investment Fund ("RDIF") for manufacturing of Sputnik-V Vaccine against the Covid-19 pandemic; its partnership with Intravacc, the Netherlands for transfer of technology for the Sabin Inactivated Polio Vaccine (sIPV) and related quality control testing for commercialization in India and other international markets; partnership with the National Institutes of Health, USA for development and commercialization in Asian and African countries of its licensed tetravalent dengue vaccine candidate and its partnership with Serum Institute and its subsidiary for supply of one of the key constituents for the EasySix vaccine and for introduction of hexavalent vaccine in national immunization programs in developing countries.

Panacea Biotec has entered into key partnerships with global pharmaceutical companies such as Apotex, Bionpharma, Natco and Breckenridge for marketing of pharmaceutical formulations in USA and other international markets, which has helped Panacea Biotec in expanding its reach and access to new regulated markets. In collaborations with Apotex, Panacea Biotec has launched Prasugrel tablets in the United States and further collaborated for R&D, license and supply of Paclitaxel Profitein bound particles for injectable suspension in the United States, Canada, Australia and New Zealand and several other countries. In collaboration with Bionpharma, Panacea Biotec has launched Tacrolimus and Rizatriptan Benzoate tablets in the United States and has four ANDAs led with USFDA which are under approval. Panacea Biotecs collaboration with Natco and Breckenridge is for manufacturing and supply of Azacitidine injection in the United States.

Internal Audit & Internal Financial Control System

Panacea Biotec has a comprehensive internal control system that commensurate with its size and nature of operations. This system spans across the organization including all the manufacturing and research & development facilities, warehouses & sales o ces besides corporate o ce.

The internal financial controls have been developed and implemented at each business process across Panacea Biotec. The user level responsibilities are constantly shared with key users for their implementation and compliance. Checks & balances and control systems have been established to ensure that assets are safeguarded, utilized with proper authorization and recorded in the books of account. There is a proper deonition of roles and responsibilities across the organization to ensure information o w and monitoring. Further, internal audits are conducted periodically by PriceWaterhouseCoopers LLP (PWC), the internal auditors of Panacea Biotec, an internationally renowned independent rm of Internal Auditors. The Audit Committee of Panacea Biotec actively reviews the adequacy and effectiveness of internal controls, internal audit systems and advises improvements as may be required. Post audit follow-ups are carried out to ensure identioed risks are addressed and recommendations of the Audit Committee are implemented. Panacea Biotec has established and maintained adequate and effective internal financial controls over financial reporting (IFCoFR) in accordance with the framework. Panacea Biotec with the help of the independent Internal Audit rm has performed an overall design assessment of the business processes as part of the Internal Financial control reviews. This includes review of policies and procedures adopted by Panacea Biotec for ensuring the orderly and efficient conduct of its business and xing responsibility against all the controls. The design assessment was followed up by the management testing of the controls across processes.

FINANCIAL PERFORMANCE

Summarized Consolidated Balance Sheet

(Rs. in million)

Particulars As at March 31, 2021 As at March 31, 2020
Assets:
Fixed assets 6,431.16 6,813.93
Financial assets 68.98 18.71
Other non-current assets 178.31 237.65
Current assets 4,742.26 3,594.97
Asset classied as held f or sale and discontinued operations 367.45 3,237.74
Total Assets 11,788.16 13,903.00
Equity & Liabilities:
Total Equity (2,316.93) 1,957.49
Non-current liabilities 9,848.46 7,426.03
Current liabilities 4,256.63 4,135.12
Liabilities directly associated with discontinued operations - 384.36
Total Liabilities 11,788.16 13,903.00

Fixed Assets: The net oxed assets have decreased to Rs.6,431.16 million as against Rs.6,813.93 million as at the end of previous year mainly on account of depreciation during the year under review.

Non-current Financial Assets: Non-current financial assets include long-term investments, loans and other long-term financial assets. The non-current financial assets as at March 31, 2021 have increased to Rs.68.98 million from Rs.18.71 million as at the end of previous year.

Other Non-Current Assets: Other non-current assets include deferred tax asset (net of MAT credit) and other non-current assets. The non-current assets as at March 31, 2021 have decreased to Rs.178.31 million as against Rs.237.65 million as at March 31, 2020 mainly due to realization of the investment in joint venture upon its liquidation.

Current Assets: Current assets include inventories, trade receivables, cash & cash equivalents, other bank balances, short term loans and other current assets. Total current assets have increased to Rs.4,742.26 million from Rs.3,594.97 million as at the end of scal 2020 mainly due to increase in the inventories, trade receivables and other current assets. Total Equity: The Total Equity turned negative at Rs.2,316.93 million as at March 31, 2021 as compared to Rs.1,927.49 million as at March 31, 2020, mainly on account of the demerger of real estate business.

Non-Current Liabilities: Non-current liabilities include long term borrowings (excluding current maturities), provisions and other non-current liabilities. The non-current liabilities as at March 31, 2021 have increased to Rs.9,848.46 million as compared to Rs.7,426.03 million as at March 31, 2020. The increase is mainly on account of increase in the accrued interest on non-convertibles debentures issued by PBPL. Current Liabilities: Current liabilities include short-term borrowings, trade payables and other current onancial liabilities (including current maturities of long term borrowings). The current liabilities as at March 31, 2021 have increased to Rs.4,256.63 million as compared to Rs.4,135.12 million as at the end of previous year, mainly due to increase in trade payables.

Liabilities directly associated with discontinued operations: This represents liabilities directly pertaining to the Companys real estate business (demerged into Ravinder Heights Ltd.) which were considered as discontinued operations as per the Ind-AS. Total liabilities associated with discontinued operations as at March 31, 2021 has reduced to Nil as compared to Rs.384.36 million upon completion of demerger of real estate business.

Summarized Consolidated Statement of Profit & Loss Continuing Operations Income from Operations

Revenue from Operations: The consolidated revenue from operations increased by 14.84% from Rs.5,440.62 million for Fiscal 2020 to Rs.6,248.05 million for Fiscal 2021, primarily due to increase in revenue from vaccine business driven by

(Rs. in million)
For the year ended
Particulars March 31, 20201 March 31, 2020
Continuing operations:
Revenue from operations 6,248.05 5,440.62
Materials & Finished Goods Purchases 2,046.31 1,567.95
Employee benets expense 1,561.73 1,423.21
Other expenses 1,873.72 2,135.87
Finance Costs 1,853.35 1,739.80
Depreciation and amortization expense 455.94 432.19
Other Income 99.77 296.87
Profit/ (L oss) before tax and exceptional items (1,443.23) (1,561.53)
Share of Profit of joint v enture 0.77 3.30
Exceptional items - (153.97)
Profit/ (L oss) Before Tax (1,442.46) (1,712.20)
Provision for Taxes (including deferred tax) 19.57 166.40
Profit/(L oss) after Tax from continuing operations (1,462.03) (1,878.60)
Profit/(L oss) after Tax from discontinued operations (14.55) (64.36)
Other comprehensive income 8.20 27.54
(net of tax)
Total comprehensive income (1,468.38) (1,915.42)
Basic & Diluted EPS* from continuing operations (23.87) (30.67)
Basic & Diluted EPS* from discontinued operations (0.24) (1.05)
Total Basic and Diluted EPS* (24.11) (31.72)

*Earnings Per Share in Rs. per Equity Share of Re.1. increase in sales of hexavalent vaccine in private market in India, higher sales of pentavalent vaccines to institutions and higher export sales in the pharmaceutical business, primarily in ICH markets.

Other Income: Other income has decreased by 66.39% from Rs.296.87 million for Fiscal 2020 to Rs.99.77 million for Fiscal 2021, primarily due to higher write back of excess provisions during Fiscal 2020.

Expenditures

Materials & Finished Goods purchases: The raw & packing materials and finished goods purchases have increased to Rs.2,046.31 million as against Rs.1,567.95 million during previous financial year, mainly on account of higher revenue from operations. Employee beneots expenses: The employee beneots expenses have increased by 9.73% from Rs.1,423.21 million for Fiscal 2020 to Rs.1,561.73 million for Fiscal 2021, primarily on account of increase in manpower and annual increment in salaries and wages.

Other Expenses: The other expenses have decreased by 12.27% from Rs.2,135.87 million for Fiscal 2020 to Rs.1,873.72 million for Fiscal 2021, primarily due to decrease in allowance for expected credit loss and doubtful advances, decrease in loss on sale of property and decrease in travelling & conveyance and meeting & conference expenses. Finance costs: Finance costs comprising of interest and bank charges has increased by 6.53% from Rs.1,739.80 million for Fiscal 2020 to Rs.1,853.35 million for Fiscal 2021. This increase was primarily on account of increase in accrued interest on existing debts as per the terms of debts.

Depreciation and amortization expenses: Depreciation and amortization expenses have increased by 5.50% from Rs.432.19 million for Fiscal 2020 to Rs.455.94 million for Fiscal 2021, primarily due to additional equipment purchased in Fiscal 2021 forming part of the recurring capital expenditure. Loss Before Tax: The loss before tax from continuing operations decreased by 15.75% from Rs.1,712.20 million for Fiscal 2020, to loss of Rs.1,442.46 million for Fiscal 2021, as a result of the factors discussed above and absence of any exceptional items during Fiscal 2021.

Loss After Tax: The total loss for the year from continuing operations decreased by 22.17% from Rs.1,878.60 million for Fiscal 2020, to loss of Rs.1,462.03 million for Fiscal 2021, as a result of the factors discussed above.

Loss after tax from discontinued operations

The net loss after tax from discontinued operations decreased by 77.39% from Rs.64.36 million in Fiscal 2020 to Rs.14.55 million for Fiscal 2021.

Earnings per Share

The basic and diluted EPS from continuing operations was negative Rs.23.87 per share for Fiscal 2021 as against negative EPS of Rs.30.67 per share for Fiscal 2020. The basic and diluted EPS from discontinued operations was negative Rs.0.24 per share for Fiscal 2021 as against negative EPS of Rs.1.05 per share for Fiscal 2020. Overall basic and diluted EPS from continuing and discontinued operations was negative Rs.24.11 per share for Fiscal 2021 as against negative EPS of Rs.31.72 per share for Fiscal 2020.

Summarized Consolidated Cash Flow statement

(Continuing and Discontinued Operations)

(Rs. in million)

Particulars For the year ended
March 31, 2021 March 31, 2020
Cash Flows from:
Operating Activities 1,067.64 (304.70)
Investing Activities (476.79) (347.60)
Financing Activities (471.10) 907.39
Cash & Cash Equivalent 520.79 402.18
at the end

Cash Flow from Operating Activities: Net cash generated from operating activities was Rs.1,067.64 million for Fiscal 2021 as compared to Rs.304.70 million net cash used for Fiscal 2020, primarily on account of increase in operating proot and positive working capital changes during Fiscal 2021.

Cash Flow from Investing Activities: Net cash used in investing activities was Rs.476.79 million for Fiscal 2021, primarily on account of payment towards purchase of xed assets and increase in bank deposits. Net cash used in investing activities was Rs.347.60 million for Fiscal 2020.

Cash Flow from Financing Activities: Net cash used in onancing activities was Rs.471.10 million for Fiscal 2021, primarily on account of payment of interest. Net cash generated by financing activities was Rs.907.39 million for Fiscal 2020, primarily on account raising of non-current borrowings.

Details of Ratios

Signicant changes vis-a-vis immediately preceding financial year were reported in the following ratios:

Consolidated
Ratio FY21 FY20 Reasons of Variance
Interest Coverage Ratio 0.49 0.62 Declined due to increase in interest cost
Current Ratio 1.11 0.87 Improved due to increase in current assets
Debtors Turnover Ratio 8.16 6.92 Improved due to higher sales without corresponding increase in debtors
Inventory Turnover 1.27 1.37 Declined due to increase in inventory
Ratio Debt Equity Ratio -4.53 4.37 Declined due to erosion in equity on account of demerger of real estate business and losses
Operating Profit 12.85% 14.19% Declined due to increase in operating cost
Margin %
Net Profit Margin %
- before exceptional items -23.40% -31.70% Improved due to reduction in losses
- after exceptional items -23.40% -34.53%
Return on Net worth %
- before exceptional items NM -86.8% Not measurable (NM) due to erosion in equity on account of demerger of real estate business and losses
- after exceptional items NM -94.5%

Opportunities and Outlook

The Company operates in a highly regulated and competitive environment across multiple geographies. Panacea Biotec is engaged in research, development, manufacturing and marketing of a wide range of branded and generic pharmaceutical formulations and novel vaccines. The Management continues to be committed to grow the Companys business building on its strong foundation and executing its pipeline of products.

SWOT Analysis

Strengths

Leading biotechnology company with over 30 years experience in development, manufacturing and commercialization of vaccines and pharmaceutical formulations

One of the leading domestic formulations player - Strong brands in niche segments with signicant market share in respective therapeutic segment Global footprint with signicant focus on exports State-of-the-art manufacturing facilities - cGMP compliant and USFDA approved Established research & development and clinical research capabilities with multi-disciplinary R&D Centers Robust product pipeline of promising niche products to fuel long-term growth Extensive sales and distribution network Growing Strategic partnerships and collaborations Strong promoter group supported by experienced and qualied management team

Weaknesses

Long Gestation Period on R&D Projects: R&D projects involve longer development time and medium to high investment as is the norm in the vaccine and pharmaceutical industry. As a result of this, the present Profitability is affected whereas the output may come in medium to long term future periods.

High Dependence on Institutional Business in Vaccine Segment: A signiocant part of the vaccine business revenues comes from tender driven institutional business. Panacea Biotec has decided to focus on expanding into private markets in India as well as in ROW countries through strategic tie-ups to have a diverse sales base and reduce its dependence on institutional business.

Revenue Concentration on Few Products: In vaccine segment, the revenue generation is mainly dependent on two products i.e. pentavalent and hexavalent vaccine. Any future disruption in any of these products may impact the future financial performance.

Higher level of Debt nancing: Currently, there is a higher level of debt in Panacea Biotec Pharma in the form of Non- convertible debentures. However, Panacea Biotec is in the process of raising funds for partial reduction of debt.

Opportunities

To improve Capacity Utilization

New products in pipeline for Commercial Launch

Use of in-house drug substance in place of the imported drug substance thereby reducing dependence on third party suppliers

Threats

Dependence on few imported suppliers in drug substance. However, Panacea Biotec is focusing on reducing its dependence on foreign suppliers by developing in-house drug substances at Lalru.

Price Control by Government: Pharmaceutical industry per-se is facing price control risk from the Government and the Government has been frequently oxing the ceiling prices and bringing more and more products under the price control mechanism.

Increasing Regulatory Compliances and Costs: International regulatory agencies like USFDA have started exercising greater controls and compliances. As a result of this, the cost of compliance has also started increasing. Many Indian companies have been disqualied by USFDA due to non-compliance with cGMP guidelines. However, the Company has been following the guidelines prescribed by USFDA and other regulatory agencies and save and except, recent observations / warning letter from USFDA which has been suitably responded / acted upon, Panacea Biotec has successfully passed USFDA audit thrice in last 4 years.

Pricing pressure amid intense competition in the

Pharmaceutical industry across the globe.

High volatility in currency exchange rates may affect the

Industry adversely.

Risk of all R&D initiatives not leading to commercially

viable and successful products.

Future Growth Strategy

Vaccine Business

Short to Medium Term:

TM

Scaling up EasySix vaccine sales in Private Market in India.

Increasing participation in institutional business for

Easyv e-TTR vaccine.

Commercialization of Covid-19 vaccine in collaboration with RDIF

Continuing development of tetravalent Dengue vaccine DengiALLR, Pneumococcal Conjugate Vaccine NucoVacR and other vaccines.

Launch of Pneumococcal Conjugate Vaccine NucoVacR in India.

TM

Introduction of EasySix vaccine in UNICEF / PAHO Program, private markets and National Program of developing countries.

Launch of tetravalent Dengue Vaccine DengiALLR in India. Launch of other vaccines which are currently under development.

Long Term:

Scale up of sales of DengiALLR vaccine and NucoVacR vaccine in Private Market in India.

Launching these vaccines in Developing Countries

National Program etc.

Launch of Vaccines which are currently under advanced stage of pre-clinical studies in India and developing countries.

Pharma Business

Short to Medium Term:

Growth in domestic Pharmaceutical Formulations business through introduction of new products and increasing sales force productivity.

Growth in exports of Pharmaceutical Formulations to emerging markets.

Scaling up of existing niche generic business in USA. Increase Patient connect for sustainable growth. Launch of Paclitaxel Profitein bound particles for injectable suspension, Cyclosporine and other products which are currently under approval in USA.

Filing more ANDAs / dossiers in USA and European markets.

Launch of new products in domestic and international emerging markets.

Long Term:

Launch of more products in US, EU and other ICH markets. Launch of new products in domestic market, emerging and developing countries.

Safety, Health and Environment Profitection

The Company undertakes all its operations with a high concern and sincerity for environment and its surrounding as well as the safety and health of people. The Company has dedicated Environment, Occupational Health and Safety (EOHS) department and also engages the services of consultant for independent evaluation of EOHS activities.

Corporate Social Responsibility

Panacea Biotec recognizes Corporate Social Responsibility as one of its core values by making continuous efforts on spreading awareness on critical health issues impacting the quality of life. Panacea Biotec has been over the years, pursuing Corporate Social Responsibility by putting continuous efforts in the areas of health, education and patient awareness / assistance programs towards the development of a happier and healthier society. Panacea Biotec has been actively engaged in conducting patient camps such as diabetes detection, HbA1C and diabetic neuropathy camps to help patients better manage diabetes and co-morbid conditions, cancer survivor meets to help patients manage life post chemotherapy, organ donation awareness campaigns to spread awareness and positive impact of organ donation, osteoporosis camps to help patients identify risk of osteoporosis ahead of time and piles camps for detection, management and awareness of piles. These camps are conducted across the country with an objective to provide free diagnostic services to the patients and spread awareness on lifestyle management with such chronic diseases to help improve their quality of life. During Covid-19 pandemic in FY 2020-21, the Company organized multiple sanitization camps and awareness camps across Doctors clinics.