panacea biotec ltd share price Management discussions


GLOBAL VACCINE MARKET

There has been significant progress in the global vaccine industry over the last few decades. Vaccines immunization programs run across the countries, have saved millions of lives every year. The number of vaccine manufacturers are increasing and so is the capacity to produce vaccines, with more than 90 manufacturers supplying vaccines to World Health Organization (WHO) member states in 2021.

Covid-19 pandemic gave a strong push to the vaccine industry globally by creating awareness about the importance of vaccines as a life-saving tool. As per WHOs Global Vaccine Market Report 2022, the global vaccine portfolio has been expanding over the past decades, with the development of new vaccines against diseases that primarily affect lower-income countries (such as meningococcal meningitis A, hepatitis E, dengue fever, ebola, malaria) in addition to those targeted at more a uent countries. As per industry estimates, the global vaccine market is expected to reach RsUS$ 43 billion in 2023 and is further expected to grow to RsUS$ 80 billion by2033, growing at a CAGR of Rs6.6%.

Future growth in the global vaccine market is expected to be driven by increased availability of a ordable vaccines, growing awareness on immunization and vaccination benets in emerging markets supported by government led immunization programs. WHO continues to take initiatives to increase awareness of immunization through Global Vaccine Action Plan (GVAP) and Global Immunization Vision and Strategy (GIVS). Growth in the Asia-Pacic markets is driven by large population base, rising prevalence of infectious diseases, increasing vaccination awareness & acceptance and high expenditure by governments.

Dynamics of Global Vaccine Market

Driver: Increasing focus on immunization programs: The focus on immunization has increased considerably with rising healthcare awareness, and a number of government organizations are undertaking initiatives to meet this goal. National Governments fund National Immunization Programmes (NIP) through public market tenders or procurement through UN Agencies like United Nations Childrens Fund (UNICEF), Pan American Health Organization (PAHO), etc. There are vaccines over 16 diseases, including measles, diphtheria and whooping cough (pertussis) as well as the more recently developed vaccines, such as the human papilloma virus (HPV) and meningococcal quadrivalent (ACWY) vaccines that are covered by NIPs. Global Alliance for Vaccine Initiatives (GAVI) and other donor agencies are routinely providing support including technical expertise and funds to national Governments to adopt new vaccines.

Over Rs100 million children born in the Rest of the World (ROW) countries receive vaccines through UN Agencies or through their national Governments. These purchases have ramped up the growth in the vaccine market since early 2000, wherein GAVI has helped adopt more than 16 vaccines in global immunisation program through market and non-market activities including providing funding to different manufacturers for development of vaccines.

Restraints: Low purchasing power in developing countries: The traditional six vaccines under the Expanded Programme on Immunization (EPI), viz. measles, diphtheria, pertussis, tetanus, oral polio, and bacille calmette-guerin (BCG - vaccine for tuberculosis disease) are mature products. High x ed costs and a steep learning curve make new vaccines relatively more expensive, as the investments in R&D and production facilities need to be recovered and production techniques need to be optimized and perfected to bring down variable production costs. New vaccines that involve recombinant DNA (rDNA) or messenger RNA (mRNA) technology are newer age technologies that have been proven during the Covid-19 pandemic and pose new threats to replace traditional vaccines. However, cost considerations, ease of use and high acceptance rates of traditional vaccines will continue to remain barriers in adoption of newer vaccine technologies.

Non-market activities undertaken by international organisations without competitive process may discourage private investments in development of vaccines as it creates unreal pricing pressures for manufacturers trying to enter the market without such extramural funding (like grants, etc.), creates barriers to entry, and uncertainty regarding viability. These market and non-market factors together continue to threaten the business case of developing novel vaccines that are or could potentially be included in the priority pathogen list.

Opportunities: Focus on newer technologies, therapeutic vaccines and pandemic preparedness: Therapeutic vaccines enable corrective treatment, as opposed to preventive vaccines. An improved understanding of immunology has resulted in the opportunity to develop these therapeutic vaccines for the treatment of cancer, allergies, physiological disorders, and infectious diseases. Such diseases have a large patient base that desperately seeks alternative safer treatments. Scientists have attempted to develop novel therapeutic vaccines against hypertension, dyslipidaemia, alzheimers disease, cancer and in ammatory diseases by targeting self-antigens. If the e cacy and safety of vaccines can achieve an effect equivalent to that of medication, vaccines may be an alternative to daily medication for the treatment of lifestyle diseases.

Market generation activities undertaken by international organisations continue to increase the number of vaccines being covered by the National Immunization Programs and the number of countries are rolling out the WHOs recommended schedule for vaccination either through self-funded or donor funded programs. Vaccines targeting priority pathogens continue to provide large-scale opportunities for expansion as each such vaccine chosen can immediately reach more than 100 million babies born every year.

Such efforts by agencies like GAVI will continue to benet Panacea Biotecs pipeline candidates. Under GAVI 4.0, GAVI Boards "in principle" support decision in 2018 was a strong signal that incentivised multiple manufacturers to pursue their hexavalent vaccine development plans which will help create a healthier and more competitive market in the medium and long term. Additional engagement by Alliance partners has improved several market attributes to ensure a successful launch of hexavalent vaccine, especially at a price that was optimized in the latest UNICEF tender owing to a cross-alliance e ort. As part of the Alliances Vaccine Investment Strategy (VIS 2018), the wP-hexavalent vaccine (rst launched by Panacea Biotec in March 2017 under the TM brand name, EasySix ) was prioritized. In June 2023, GAVI conormed the adoption of the wP-hexavalent vaccine creating a market for over 250 million doses annually by 2030 in GAVI countries.

With GAVI 5.0 (2021-2025), there is renewed interest in the public market adoption of dengue vaccine. Panacea Biotec will soon be undertaking Phase III clinical trial of its candidate tetravalent dengue vaccine, DengiAllR, in India. The Alliances proposal to encourage large-scale immunization programs will create a sustainable market for such vaccine beyond India.

Challenges: Vaccine misinformation: Misconception about vaccines often arises when there are information gaps or unsettled science, as human nature seeks to reason, better understand, and ll in the gaps . In the first 3 months of 2020, nearly 6,000 people around the globe were hospitalized because of coronavirus misinformation. During this period, researchers say atleast 800 people may have died due to misinformation related to Covid-19. Vaccine misconceptions and misinformation are a major concern among governments, funding agencies, vaccine manufacturers and suppliers, and other stakeholders alike. Low acceptance rates due to vaccine misinformation result in the lower market penetration of effective and safe vaccines, which could adversely affect the market.

INDIAN VACCINE MARKET

India is one of the largest vaccine producing countries and is a global leader in the supply of DPT, BCG, and Measles vaccines. India continues to be one of the biggest suppliers of a ordable vaccines in the world. India accounts for Rs60% of global vaccine production, contributing Rs40 to 70% of the WHO demand for diphtheria, tetanus and pertussis (DPT) and bacillus calmette guerin (BCG) vaccines, and Rs90% of the WHO demand for the measles vaccine.

Universal Immunization Programme (UIP) run by the Government of India is one of the largest public health programmes in the world, covering Rs30 million pregnant women and Rs27 million newborn babies annually. Under UIP, the Government of India is providing vaccination free of cost against 12 vaccine preventable diseases. NucoVacR11 competes in this market with major entrants being Pz er, GSK, Serum Institute of India, Biological E, Aurobindo / Tergene, etc.

The Indian vaccine market is estimated at Rs 130 billion in 2022. The market is further expected to reach Rs 350 billion by 2028, growing at a CAGR of Rs18%.

The future growth in the Indian vaccine industry will be driven by several factors like government led immunization programs, investment support in research & development (R&D) by government funding agencies, increased awareness and income levels allowing people to vaccinate their families against deadly diseases. In addition, technological advancements, higher manufacturing capacities and cold chain storage facilities are also expected to support the future growth of the Indian Vaccine Industry.

Panacea Biotec is committed towards growth of the Indian private market vaccine franchise with additional launches TM scheduled in the next 18 to 24 months. EasySix (the worlds first fully-liquid wP-based Hexavalent vaccine) continues to be the market leader. We hope to introduce NucoVacR11 and DengiAllR among other products to meet unmet medical needs.

GLOBAL PHARMACEUTICAL MARKET

The global pharmaceutical market witnessed marginal growth during the year 2022 growing to RsUS$ 1.48 trillion from RsUS$ 1.42 trillion in 2021. The global pharmaceutical industry is expected to grow to RsUS$ 1.9 trillion by 2027 growing at 3-6% annually. The growth will mainly be driven by launch of new drugs, increased use of recently launched products and the availability of low cost products. The future growth will mainly be driven by critical therapeutic areas like oncology, immunology, cardiology and neurology which are the fastest-growing therapeutic areas at present and will continue in future. An ageing population in many developed markets will also create higher demand for medicines. In particular, demand for chronic disease medicines will grow in the mid and long-term. Pharmaceuticals demand in emerging markets is set to increase due to improvements in healthcare systems and growing disposable household incomes.

INDIAN PHARMACEUTICAL MARKET

India holds a key position in the global pharmaceutical rd industry and continues to be the 3 largest pharmaceutical th producer by volume and 14 by value worldwide. India is the worlds largest supplier of generics, accounting for Rs20% of global generic exports and supplies over 40% of the demand for generic products in the USA. The pharmaceutical exports from India reach more than 200 nations around the world, including highly regulated markets of the USA, Europe, Japan, and Australia.

The country has an established domestic pharmaceutical industry, with a strong network of Rs3,000 pharmaceutical companies and Rs10,500 manufacturing units. The pharma sector currently contributes to around 1.72% of the countrys GDP. As per the Government data, the overall size of the Indian pharmaceutical industry is estimated at RsUS$ 50 billion out of which the Indian pharmaceutical exports were to the tune of RsUS$ 25.39 billion in onancial year 2022-23. The Indian pharmaceutical industry has seen a signicant expansion over the last few years and is expected to reach about 13% of the size of the global pharma market while enhancing its quality, a ordability, and innovation. The Indian pharmaceutical industry is expected to reach RsUS$ 65 billion by 2024, and RsUS$ 130 billion by 2030.

NUTRITION MARKET IN INDIA

The Health Food Drink (HFD) Nutrition category comprises of regular, adult, children & maternal sub-sets with an estimated size of over 50 billion. The market category for nutrition products for children is estimated to be Rs 5.3 billion with East India at highest saliency of 42%, followed by South at 27%, North at 18% and West at 13%.

PANACEA BIOTEC BUSINESS AND STRATEGY

Most of our revenues come from the manufacture and sale of biopharmaceutical products. With the divestment of India focused pharmaceutical formulation brands portfolio during FY2021-22, Panacea Biotec is now more focused on vaccines and international pharma business with science-based innovative medicines and vaccines. Panacea Biotec has also identied nutrition segment as a new business area to enter and focus for its future growth.

We believe that we have a strong pipeline and are well positioned for future growth. Research & Development is at the heart of fulolling our purpose to deliver a ordable innovations that enable people to live well and live longer. Our R&D efforts seek to add value to our existing products by improving their effectiveness, ease of dosing and reducing cost of manufacturing. We seek to leverage a strong pipeline, organize around expected operational growth drivers and capitalize on trends creating long-term growth opportunities.

We are committed to strategically capitalizing on growth opportunities, primarily by advancing our own product pipeline and maximizing the value of our existing products, but also through various business development activities. We view our business development activity as an enabler of our strategies and seek to generate growth by pursuing opportunities and transactions that have the potential to strengthen our business and our capabilities. We assess our business, assets and scientic capabilities / portfolio as part of our regular, ongoing portfolio review process and also continue to consider business development activities that will help advance our business strategy.

VACCINES BUSINESS

Panacea Biotec has established brand equity in research, development, manufacturing and marketing of innovative vaccines supported by experience of over four decades in the vaccine industry. Our innovations have helped increase paediatric immunization coverage, provided signiocant savings in the overall cost of immunization and saved the lives of millions of children in developing countries. We have a strong legacy as a global vaccine player with a track record to bring rst-t o-market innovative products like:

Worlds first fully liquid wP -IPV based hexavalent vaccine,

TM

EasySix (DTwP-HepB-Hib-IPV)

Worlds first fully liquid wP based pentavalent vaccine, Easyv e-TTR (DTwP-HepB-Hib)

Worlds first mono valent oral polio vaccines (mOPVs) and bivalent oral polio vaccine (bOPV with Poliovirus Type 1 and Type 3), Bi-OPVR.

Panacea Biotec is one of the leading manufacturers of paediatric vaccines and has played a pivotal role in eradication of Poliomyelitis 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 more than 10 billion doses of polio vaccine in India and developing countries and supplied vaccines for more than 150 million immunizations by supplying fully liquid wP based combination vaccines.

During the year, total revenues from vaccines business has increased to 2,569.87 million from 2,347.71 million in financial year 2021-22, registering a growth of Rs9.5%. The revenue from export of vaccines was to the tune of 2,102.25 million as against 1,253.99 million during previous year, registering a growth of 67.6%.

The existing commercialized product portfolio of the Company includes key proprietary vaccines, hexavalent vaccine EasySix , fully liquid tetravalent vaccine (DTwP-Hib) Easyfour-TTR, WHO prequalioed fully-liquid pentavalent vaccine Easyv e-TTR, and bivalent poliomyelitis vaccine Bi-OPVR. The Company is in process of launching the worlds first fully-liquid wP-IPV based Pentavalent vaccine (DTwP-Hib-IPV) Easyfour-PolR during the current financial year to further augment its position in the segment - complete protection with ease of administration.

Easyove-TTR is the worlds orst fully liquid wP-based Pentavalent vaccine that was launched in India in 2005. After receiving WHO pre-qualiocation in 2008, more than 150 million doses have been supplied to over 75 countries globally. It is a ready-to-use combination vaccine that does not require preparation by healthcare workers at the clinic, reduces the number of visits to vaccination centers, and reduces the overall cost of immunisation for all stakeholders.

The Company has pioneered in the development of vaccines ranging from recombinant, polysaccharide conjugate and viral vaccines. The Company has a strong pipeline of vaccines under development to boost its future growth including DengiAllR a single dose live-attenuated tetravalent vaccine against Dengue fever, NuCoVacR11 a pneumococcal polysaccharide conjugate vaccine (11-valent), Td (Tetanus and Diphtheria reduced) Vaccine, Hepatitis A vaccine and a multi-epitope nanoparticle based broadly protective Betacoronavirus candidate vaccine.

The Phase III clinical trial for Td vaccine is in progress and is expected to be completed in due course. The Phase III clinical trial for DengiAllR and Phase II / III clinical trial for NucoVacR11 vaccines are expected to commence in India during current financial year. The Company has collaborated with Indian Council of Medical Research (ICMR) for the Phase III clinical trial of DengiAllR vaccine.

The Company has a eld force of around 150 persons spread across the country to regularly reach out to nearly 10,000 pediatricians across India.

Panacea Biotec has been one of the largest suppliers of vaccines to multilateral agencies like UNICEF, PAHO, etc. and has been supplying vaccines to institutional customers and national Governments for over two decades. As part of the Companys strategy to enter into international private vaccine market, the Company has already registered its vaccines in around 12 countries. The product registration in 30 additional countries is in progress and is expected to be approved in due course.

Panacea Biotec is the innovator and intellectual property holder of EasySix , the worlds first fully-liquid Hexavalent vaccine. The WHOs Strategic Advisory Group of Experts on Immunization (SAGE) has supported the global rollout of wP based hexavalent vaccine in the global immunization schedule creating an opportunity for more than 250 million doses of hexavalent vaccine annually. Panacea Biotec is in the process of expanding its manufacturing capacities in order to meet the growing demand of vaccines in future by public health agencies.

Besides supplying pentavalent vaccine Easyv e-TTR and Bi-OPVR, the Company will also be seeking WHO prequalication of its pipeline products for supply to UN agencies and other national Governments.

Panacea Biotec is supporting global cause of providing a ordable vaccines to the children across the globe and it works closely with global organizations like WHO, GAVI, UNICEF, PAHO, CEPI, Bill & Melinda Gates Foundation (BMGF) and Clinton Health Access Initiative (CHAI), etc. 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 through its wholly-owned subsidiary Panacea Biotec Pharma Limited ("PBPL" or "Panacea Biotec Pharma") had an established business of pharmaceutical formulations in India and exports its products to Rs36 countries worldwide including the United States, Germany, Russian Federation, Serbia, Bosnia, Tanzania, Kenya, Jordan, Vietnam, Philippines, Sri Lanka, Panama, Ecuador, Trinidad & Tobago, Uganda etc. During the year, PBPLs revenue from exports of pharmaceutical products were 1,387.77 million as against 1,632.24 million during previous financial year. During the current onancial year, PBPL has also started export of Paclitaxel generic product for launch thereof in Canada.

The international pharmaceutical formulation product portfolio includes innovative prescription products in niche therapeutic areas such as transplantation, renal disease, oncology, respiratory, pain management, diabetes and gastro-intestinal care.

PBPL has continued its focus on development, registration and marketing of products portfolio catering to chronic therapies in private markets in several countries.

PBPL is continuously ling new product registration dossiers in existing as well as new markets to further strengthen and grow its exports in the future. The Abbreviated New Drug Applications (ANDA) submitted under section 505(j) of the Federal Food, Drug & Cosmetics Act are in process of approval by the U.S. Food and Drug Administration ("USFDA"). PBPL plans to launch these products in US, Europe, etc. through strategic collaborations with leading pharma companies. It has key partnerships with global pharmaceutical companies for marketing of pharmaceutical formulations in USA, Canada and other international markets, which has helped in expanding its reach and access to new regulated markets.

PBPL has taken more initiative on brand building & customer connect through various mass promotion programs through online media, in-clinic discussions through digital mobile platform, scientioc education initiatives (CMEs), product specioc medical trainings, country specioc strategies & scientic promotions and medical training programs.

PBPL 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 is developing a portfolio of products for European markets, GCC countries and other emerging markets.

NUTRITION BUSINESS

Panacea Biotec Pharma has recently entered into a new business of research, development, manufacturing and marketing of nutrition products. It has developed its own product portfolio for the nutrition segment at its Sampann R&D Center and has set-up a manufacturing facility to manufacture these products at Baddi, Himachal Pradesh.

To start with, in June 2023, PBPL has launched pediatric

TM nutrition products under the brand name, ChilRunfull ,

ChilRunR7+, ChilRunRNo Sucrose in Rs100 territories across India covering almost 4,000 doctors. It plans to add more products going forward to expand the product portfolio and markets including other specialties like gynecology and adult nutrition.

Supply Chain Management

Panacea Biotec is committed to ensure timely availability of its products to its business partners and patients. It 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 the vaccines, pharmaceuticals and nutrition products.

The Company has a strong logistics network comprising of 2 Central Warehouses and 23 Sales Depots / Carrying & Forwarding Agents (CFAs) / Super stockiests (comprising of vaccine and nutrition business). Vaccine and nutrition products availability across India is ensured through vast distributor network of around 1,000 distributors (including 400 new stockiests added in FY2022-23 to cater nutrition business) as on March 31, 2023, which enable us to have a pan-India presence and access to a wide market base. Separate trade team has been set-up for regular coordination with stockiests to address supply challenges, if any. The Company has plan to add another 600 stockiests in the next 2 years to increase the reach to the customers.

The Company has collaborated and appointed world class logistics providers, clearing agents and airlines with proven record of timely delivery of goods in export markets in Asia, Europe, Africa, North & South America.

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.

Panacea Biotec has a well-established Track and Trace system and documentation quality to ensure timely delivery of goods at the destination and 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.

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 at Baddi, Himachal Pradesh, which started its operations in the year 2008, comprises of two blocks. The production block is spread over approx. 2,800 M2 constructed 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 lling lines for manufacturing of bacterial, viral and recombinant vaccines including live attenuated vaccines in pre-lled syringe (PFS) and in single dose and multi-dose vial presentations. The facility also has large lyophilization capacity for manufacturing 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 and 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 Quality control laboratories of the facility are equipped with an assortment of sophisticated analytical equipment for testing of vaccines and input materials to assure quality of the product at each stage of manufacturing. The warehouse facility is equipped with cold storage and deep freezers for cold chain maintenance and dispatch management of vaccines.

Drug Substance & Biosimilar facilities at Lalru

The Company has drug substance manufacturing facilities at Lalru, Punjab which started operations in the year 2002 with separate blocks for manufacture of recombinant, bacterial and viral vaccine drug substances. 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 vaccines

Recombinant hepatitis B surface antigen, haemophilus inouenza type b conjugate (Hib-TT), diphtheria, tetanus toxoids and inactivated whole cell pertussis drug substances 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 WHO prequalioed pentavalent vaccine Easyv e-TTR.

The Company is undertaking expansion of its drug substance manufacturing capacities to be able to meet the future growing demand of its vaccines by UN agencies and national Governments in various countries. The expansion project is expected to be completed during the current financial year after which the Company will seek the approval of expanded facilities from the Indian NRA and WHO.

Pharmaceutical Formulations Facility at Baddi

Panacea Biotec Pharma has a state-of-the-art pharmaceutical formulations facility at Baddi, Himachal Pradesh which became operational in year 2006. The facility is equipped for bilayer tablets, complex sustained release coatings and delayed release coatings. The facility has received several certiocations and accreditations from international regulatory authorities including USFDA, The National Institute of Pharmacy and Nutrition OGYEI Hungary (EU), Federal Service for Surveillance in Healthcare (Russian Federation), Ministry of Health Ukraine, National Agency for Drug and Food Control, (Indonesia), Turkish Medicine and Medical Devices Agency, 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 Oral-solid, semi-solids and liquid oral dosage forms such as:

u 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, and functional), taste masking and fast-dissolving tablets;

u Semi-solids - ointments / creams / gels, transdermal drug delivery system; and

u Liquids- suspensions / syrups / solutions.

Cytotoxic / Oncology Facility at Baddi

Panacea Biotec Pharmas cytotoxic injectable formulation facility at Baddi, Himachal Pradesh, has dedicated lling lines for liquid & lyophilized injectables 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, The National Institute of Pharmacy and Nutrition OGYEI Hungary (EU) and other regulatory agencies.

Panacea Biotec Pharmas above facilities continues to be under the warning letter issued by the USFDA. It has undertaken several corrective and preventive measures to comply with the observations raised by USFDA. Panacea Biotec Pharma has also engaged international consultants as part of its corrective and preventive action plan to ensure that the manufacturing facilities meet the required standards. It is regularly updating USFDA of the progress made on these plans and following up with them for early inspection of the facilities.

Nutrition Product Manufacturing Facility at Baddi

Panacea Biotec Pharma has set up a manufacturing facility to manufacture nutrition products at Baddi, Himachal Pradesh which became operational in April, 2023. This manufacturing facility currently has installed capacity of Rs6 tons per day. It also plans to set up facilities for new dosage forms of nutrition products in future.

RESEARCH & DEVELOPMENT

Panacea Biotec is a progressive & innovative biotechnology company with high focus on research & development, manufacturing and marketing operations across pharmaceuticals, vaccines and natural or herbal products. The Company is guided by its vision of "Innovation in Support of Life" and strongly believes that innovation is important to the long-term success of the Company. Panacea Biotec specializes 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. Its ambitions are backed by distinguished, ultra-modern, state-of-the-art R&D Centers with around 72 scientists with deep roots within the academic community in important clusters in India, USA and Germany among other countries.

One-Stream R&D Center at New Delhi

Panacea Biotecs One-Stream Research and Development (R&D) Centre ("ORC") is a state-of-art facility to carter to all the modern aspects of vaccine development. This Centre has the capability of carrying out research activities for developing vaccines using various advanced genetic engineering technologies, molecular biology, bacterial culture, animal cell culture, small scale and pilot scale fermentation, puriocation and analytical characterization and formulation development. It is equipped with all the necessary infrastructure and manpower to carry out innovative research in the area of antigen design, expression of antigen and its purica tion in suitable host, upstream and downstream operation for drug substance production. This is followed by formulation with suitable adjuvant and immunological evaluation in animal model.

The Company has pioneered in the development of viral vaccine, recombinant vaccine, sub-unit vaccine and polysaccharide conjugate vaccines using both mammalian and bacterial expression platforms. In last one year, ORC has done signicant progress in these major areas of research including development of DengiAllR, NucoVacR11, Hepatitis A and a multi epitope nano-particle based vaccine for broadly protective beta coronavirus. Each of this program will signicantly addr ess the healthcare burden that the diseases pose and build a sustainable future based on innovation.

The R&D center has established a strong team to take care of the conjugation aspect of many polysaccharide based vaccines such as for typhoid, meningitis and many more in near future. The ORC team is also engaged in carrying out research for development of Hepatitis A, Varicella, RSV and Inuenza vaccine which are in our future product pipeline.

In R&D Centre we are trying to develop a multi epitope nano-particle based broadly protective beta coronavirus candidate vaccine wherein the focus is to select a lead antigen through pre-clinical testing, and initial clinical development. This research activity is supported by The Coalition for Epidemic Preparedness Innovations (CEPI) and is in collaboration with the Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India.

We are also continuously exploring to have collaborative research activities with various national laboratories and universities. We have recently signed Memorandum of Understanding with Department of Microbiology, Punjab University on collaborative research on novel vaccines.

OneStream Research Centre

SAMPANN R&D Center at Lalru

SAMPANN R&D Center of Panacea Biotec Pharma at Lalru, Punjab 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 speciality therapeutic areas. Panacea Biotec has deep experience in developing innovative drug delivery based 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. This demonstrates the Companys ability to handle the most complex generics and deliver a high-quality product in constrained and challenging timelines.

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. SAMPANN is in advanced stage of development of new products for domestic & ROW markets in the therapeutic segments of immuno-suppressant, diabetes and pain management, etc.

SAMPANN R&D Center has also successfully developed nutrition products in the pediatric segment and is developing new dosage forms and products to expand the product portfolio in other specialties like gynecology and adult nutrition.

Clinical Research

Clinical research is a critical function that guides clinical decisions based on facts and scientic data through clinical studies on vaccines and 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 vaccines and drugs 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.

Phase III clinical trial for Dengue vaccine in adults, in collaboration with ICMR, and Phase II/III Clinical trial for 11-valent Pneumococcal Conjugate Vaccine (NucoVacR11) are slated to be initiated in near future. Phase III Clinical trial for Tetanus and Diphtheria reduced (Td) Vaccine in Adolescents is already in process and is expected to be completed in due course. Further, the WHO has selected Panacea Biotec for initiating follow on fIPV (fractional IPV) study, which shall begin in due course.

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, 2023, Panacea Biotec Group 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, 2023, the Group has been granted over 464 patents globally out of which 38 are active. Some of the countries where patents have been granted are India, USA, Germany, Mexico, Brazil, ARIPO (14 African countries), Japan, Russia, Canada, Ukraine, Korea, Nigeria, Indonesia and Vietnam etc.

Panacea Biotec Group has led 289 trademark applications for registrations, out of which 165 have been registered in India, 113 have been registered outside India and 11 applications are pending registration as on March 31, 2023. Further, the

Group has 95 registered copyrights as on March 31, 2023.

HUMAN RESOURCES

At Panacea Biotec, employees are the core strength of its continuous growth in all the segments. We continue to strengthen our talent processes through cadre and capability building interventions. Panacea Biotec strongly believes in developing and grooming leaders from within the organization. The Company continues to invest in creation of a work culture representing a unique mix of its values and functional expertise and the employees are partner to achieve Vision of the Company.

Diversity and inclusion are an important organizational agenda. Taking our agenda of increasing diversity representation in the organization we have undertaken a target to increase women representation to upto 16% of our total manpower, over the next three years.

As on March 31, 2023, Panacea Biotec Group had a total manpower of Rs2,113 employees (including Rs391 through contractors) of which over 1,409 are skilled employees including corporate and managerial sta , sales sta , and sta located at its manufacturing facilities. There are Rs125 R&D professionals including Rs72 scientists engaged in R&D centers, Rs922 employees are engaged in production, quality control and quality assurance, Rs171 employees are engaged in sales & marketing and logistics and Rs 895 in other functions. Out of total employees, Rs818 employees (including Rs189 through contractors) are the employees of Panacea Biotec Pharma Limited.

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 re-skill, up-skill, multi-skill and multi-task. Panacea Biotecs endeavour has been to create a culture of high and differentiated performance where people continue to push boundaries of growth and self-development.

During the financial y ear, Panacea Biotecs focus has been on improving people productivity across the organization for which we leveraged digitalization of processes leading to reduced human intervention. We are closely tracking productivity metrics across business units to ensure better delivery of business.

We have sought to unlock sales productivity by leveraging our own internally developed tool NIKHAR- our digital capability to monitor sales productivity.

To embed the Panacea Biotecs way of execution excellence we initiated "Jaan Pehchan Ho, Kaam Aasan Ho - Face to Face Meeting" among employees at manufacturing facilities, across functional areas and across different levels and are continuing with it. We also conducted "Quality is Present" campaign across our manufacturing facilities wherein all the employees signed the pledge by undertaking that "Iss Pal Mein, Har Pal Mein Shi Se Karna, Likhna and Bolna hi Quality Hai".

Arising out of this initiative, autonomous team were formed with self-nomination amongst the functional and cross functional team members by one of the members to work as a

CAPTAIN, i.e. someone who is "Caring, Approachable, Playful, Tactful, Attentive, Inclusive, Nearest" and undertake a Topics with tasks and sub-tasks to be performed to keep the plant all time audit ready and ensure quality of the products manufactured by Panacea Biotec with clear objective of "Patient Safety".

Currently, there are 76 Captains working in different areas with a team of Rs500 employees. These team members are now shaping the new behaviour needed to succeed in all aspects of life including the Quality at Panacea Biotec.

We have established Manufacturing Sciences Group (MSG) in all 3 business segments, Vaccines, Pharmaceuticals and Nutrition to look into all aspects of operational challenges to be discussed and resolved with proper due diligence, regulatory science, data and proper analysis.

Birthday celebrations once a month for all the employees born in the month are conducted across the organization with participation across the hierarchy. Festivals are also celebrated across locations.

Recognition of good work is done through simple framework of recognition by issuance of Appreciation certicat e with a citation.

During the recent oood situation faced at Lalru, the Company saw the birth of AgniVeer comprising of a team of Rs100 people who were "Self-motivated, brave hearts roaring with emotion of Panacea FIRST". They were named as AgniVeer because of their exemplary ghting s p i r i t s h o w n d u r i n g t h e unprecedented situation and were awarded with the Recognition Certicates and T-shirts with name AgniVeer printed on it.

To facilitate growth opportunities for employees, we introduced job rotation opportunity for those who desire to be moved around or add / modify areas to their work

prole . Also, Self-led learning opportunity was oat ed at the manufacturing facilities wherein the employees were asked to indicate what they want to learn, from whom or where, company support needed, how it will help or support doing current job better etc.

To look at internal talent and give them the orst opportunity for the vacant positions or new positions created due to any reasons the positions are first adv ertised through Internal Job Posting across the organization. To ring fence key talent, additional job responsibilities are given to them through market bench marking structured communication and engagement with employees.

We analyzed the job descriptions of senior leadership teams and redeoned it to focus on role and responsibilities to manufacture quality products with Patient Safety. Arising out of redeonition of job descriptions we also organized development and coaching program which will be a continuous process.

To have certioed operators across the organization, the certiocation is conducted through Life Sciences Sector Skill Development Council, a not for proot, non-statutory certiocation body under mandate of Ministry of Skill Development and Entrepreneurship, Government of India.

We have launched implementation of Darwin Box, our new Human Resource Management System (HRMS) in the month of February 2023, in line with organizations objective of making HR operations One Click. This HRMS will engage and empower employees across the HR modules with a smarter, simpler & mobile-orst HR Tech powered by Artiocial Intelligence (AI) and Machine Learning (ML).

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 partners who market / distribute its products across several countries in the world. Panacea Biotec has a long-standing relationship with the UNICEF, PAHO 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 partnership with the National Institutes of Health, USA for development and commercialization in Asia and African countries of its licensed tetravalent dengue vaccine candidate, DengiAllR and its partnership with Serum Institute and its subsidiary for supply of one of the key constituents for the

TM EasySix vaccine and for introduction of hexavalent vaccine in national immunization programs in developing countries. The Company has also collaborated with Indian Council of Medical Research (ICMR), Government of India for Phase - III clinical trails of DengiAllR.

Panacea Biotec has entered into key partnerships with global pharmaceutical companies for marketing of pharmaceutical formulations in USA, Canada, EU and other international markets, which has helped Panacea Biotec in expanding its reach and access to new regulated markets.

Panacea Biotec will continue to strengthen its business development team and leverage its strengths in product development and navigating the regulatory landscape to capitalize on opportunities across new-age technologies that will strengthen and reposition its portfolio in the coming years.

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.

The internal audits are conducted periodically by an internationally renowned independent audit orm PriceWaterhouseCoopers Services LLP (PWC), the internal auditors of Panacea Biotec. 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 viz. PWC 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, 2023 As at March 31, 2022

Assets:

Fixed assets (net) 6,422.76 6,393.29
Financial assets 52.56 848.80
Other non-current assets 553.14 441.10
Current assets 5,623.20 9,505.55
Asset classied as held f or sale 60.00 399.95
Total Assets 12,711.66 17,588.69

Equity & Liabilities:

Total Equity* 8,436.03 8,766.36
Minority Interest (34.89) (29.81)
Non-current liabilities 992.21 1,088.47
Current liabilities 3,297.31 7,737.67
Liabilities associated with 21.00 26.00
Assets classied as held f or sale
Total Liabilities 12,711.66 17,588.69

*Excluding minority interest

Fixed Assets: The net oxed assets have increased to 6,422.76 million from 6,393.29 million as at the end of previous year.

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 of March 31, 2023 have decreased to 52.56 million from 848.80 million as at the end of previous year, mainly due to decrease in bank deposits.

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 of March 31, 2023 have increased to 553.14 million as against 441.10 million as at March 31, 2022, mainly due to classiocation of balances receivable from statutory authorities as non-current assets.

Current Assets: Current assets include inventories, trade receivables, cash & cash equivalents, other bank balances, short term loans and other current assets. Total current assets as of March 31, 2023 have decreased to million to 5,623.20 million as compared to 9,505.55 as at the end of scal 2022, mainly due to decrease in the cash & bank balances, trade receivables and inventories.

Assets held for sale: The Companys x ed assets held for sale as of March 31, 2023 were 60.00 million as compared to 399.95 million as of March 31, 2022. The decrease was mainly on account of completion of sale of an immovable property during the financial year under review.

Total Equity: Total Equity represents Equity Share Capital and other Equity. Total Equity decreased to 8,436.03 million as at March 31, 2023 as compared to 8,766.36 million as at March 31, 2022, mainly on account of losses during the financial year under review.

Non-Current Liabilities: Non-current liabilities include long term borrowings (excluding current maturities), provisions and other non-current liabilities. The non-current liabilities as of March 31, 2023 have decreased to 992.21 million as compared to 1,088.47 million as of March 31, 2022, mainly on account of reduction in borrowings.

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, 2023 have decreased to 3,297.31 million as compared to 7,737.67 million as at the end of previous year, mainly due to payment of statutory dues (pertaining to previous year) within the stipulated period and recognition of income against advance received from customers in previous year.

Liabilities associated with Assets held for sale: The liabilities directly associated with Assets held for sale as of March 31, 2023 were 21.00 million as compared to 26.00 million as of March 31, 2022.

Summarized Consolidated Statement of ProPt & Loss

(Rs in million)

For the year ended

Particulars

March 31, 2023 March 31, 2022

Revenue from operations

4,599.46 6,612.32
Materials & Finished Goods Purchases 2,526.60 2,622.05
Employee benets expense 1,264.84 1,829.73
Other expenses 1,787.61 2,292.57

Earning before Interest, tax, depreciation and amortizations (EBITDA)

(979.59) (132.03)
Finance Costs 44.37 1,808.39

Depreciation and amortization expense

391.23 437.77
Other Income 516.63 109.69

Prot/ (L oss) before tax and exceptional items

(898.56) (2,268.50)
Exceptional items 1,026.61 16,762.06

ProPt/ (Loss) Before Tax

128.05 14,493.56

Provision for Taxes (including deferred tax)

465.50 3,710.22

ProPt/(Loss) after Tax

(337.45) 10,783.34

Other comprehensive income (net of tax)

2.04 (3.99)
Total comprehensive income (335.41) 10,779.35

Basic and Diluted EPS*

(5.43) 176.05

*Earnings Per Share in per Equity Share of 1.

Revenue from Operations: The consolidated revenue from operations declined to 4,599.46 million for oscal year 2023 from 6,612.32 million for scal year 2022, primarily due to absence of revenue from sale of pharmaceutical brands in India and Nepal as the said brands have been sold during March 2022.

Other Income: Other income has increased to 516.63 million from 109.69 million for scal year 2022, mainly due to increase in interest income on deposits and write back of excess provisions.

Materials & Finished Goods purchases: The raw & packing materials and finished goods purchases have decreased to 2,526.60 million as against 2,622.05 million during previous onancial year, mainly on account of lower revenues as explained above.

Employee beneots expenses: The employee beneots expenses have decreased to 1,264.84 for scal year 2023 from 1,829.73 million for oscal year 2022, primarily on account of decrease in manpower relating to domestic pharmaceutical business in India.

Other Expenses: Other expenses have decreased to 1,787.61 million for scal 2023 as compared to 2,292.57 million for oscal 2022, primarily due to absence of the domestic pharmaceutical business during scal 2023.

Finance costs: Finance costs comprising of interest and bank charges have signiocantly declined from 1,808.39 during oscal year 2022 to 44.37 million for scal year 2023 following repayment of the non-convertible debentures and other debts.

Depreciation and amortization expenses: Depreciation and amortization expenses were 391.23 million for scal 2023 as against 437.77 million for scal 2022.

Exceptional items: Exceptional items include deferred revenue of 1,026.61 million recognized during scal year 2023 in relation to the transaction of sale of pharmaceutical formulations brands in India and Nepal as against 16,762.06 million recognised during Fiscal 2022.

Prot/(L oss) before Tax: The prot before tax was 128.05 million for scal year 2023 as against 14,493.56 million for scal year 2022, as a result of the factors discussed above.

Proot/(loss)after Tax: The total loss after tax was 337.45 million for scal 2023 as compared to prot of 10,783.34 million for scal 2021, as a result of factors discussed above.

The total basic and diluted loss per share was 5.43 for oscal year

2023 as against earning per share of 176.05 for oscal year 2022.

Summarized Consolidated Cash Flow Statement

(Rs in million)

For the year ended

Particulars

March 31, 2023 March 31, 2022
Cash & Cash Equivalent at the beginning 503.50 520.79
Net Cash o ws from Operating Activities (4,224.52) (1,084.48)
Net Cash o ws from Investing Activities 4,303.31 12,825.73
Net Cash o ws from Financing Activities (183.73) (11,758.54)
E ect of Exchange rate changes (0.04) (0.13)
Cash & Cash Equivalent at the end 398.52 503.50

Cash Flow from Operating Activities: Net cash used in operating activities was 4,224.52 million in scal year 2023 as compared to 1,084.48 million in Fiscal 2022. The increase was primarily on account of payment of current liabilities and other working capital changes during scal year 2023.

Cash Flow from Investing activities: Net cash generated from investing activities was 4,303.31 million for Fiscal 2023 as compared to 12,825.73 million for scal year 2022. During scal 2022, the net cash generation from investing activities was higher due to receipt of funds from sale of the pharmaceutical formulations brands in India and Nepal.

Cash Flow from Financing Activities: Net cash used in financing activities decreased to 183.73 million in Fiscal 2023 as compared to 11,758.54 million in Fiscal 2022. During Fiscal 2022, the usage was high primarily due to payment of interest and redemption of NCDs by PBPL.

Financial Ratios

The onancial ratios for onancial year 2022-23 and their comparison with previous year including the reasons for variance wherever applicable, are given in Note 54 to the Standalone Financial Statements forming part of the Annual Report and hence not repeated here for the sake of brevity.

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 remain committed to grow the Companys business building on its strong foundation and executing its pipeline of products.

SWOT Analysis

Strengths

u Leading biotechnology company with over 30 years experience in development, manufacturing and

commercialization of vaccines and pharmaceutical

formulations

u Signicant focus on exports

u State-of-the-art cGMP compliant manufacturing facilities u Proven research & development and clinical research capabilities with multi-disciplinary R&D Centers

u Robust product pipeline of promising niche products to fuel long-term growth

u Extensive sales and distribution network u Strategic partnerships and collaborations

u Strong promoter group supported by experienced and qualied management team

Weaknesses

u 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 protabilit y is affected whereas the output may come in medium to long term future periods.

u 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.

u 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. The Company has expedited development of new products to expand the product portfolio and drive future growth.

Opportunities

u To improve capacity utilization: The Company is working on entering into manufacturing collaborations with

third parties to increase capacity utilization of its

manufacturing facilities.

u New products in pipeline for commercial launch: The Company has several products under late stage of

development in vaccines as well as pharmaceuticals.

u Addressing unmet need: PBPLs entry in nutrition segment will help in future growth.

Threats

u 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.

u 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. The Company has been following the guidelines prescribed by WHO, 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 several regulatory audits over the years.

u Pricing pressure amid intense competition in the pharmaceutical industry across the globe. The Company

remains focused on complex generic and vaccines having

lesser competition threat.

u Risk of all R&D initiatives not leading to commercially viable and successful products.

FUTURE GROWTH STRATEGY

Vaccine Business

u Scaling up vaccine sales in private market in India including through launch of new vaccines.

u Increasing participation in institutional vaccine business with UNICEF, PAHO etc.

u Expediting development of tetravalent Dengue vaccine DengiAllR, Pneumococcal Polysaccharide Conjugate

Vaccine NucoVacR11 and other vaccines and launch

thereof in India and Institutional markets.

u Expanding manufacturing capacities to meet the future growing demand of vaccines.

u Supply of hexavalent vaccine to UNICEF, PAHO and other international markets.

Pharma and Nutrition Business

u Growth in exports of pharmaceutical formulations to ICH market, emerging markets in LATAM and Middle East.

u Launch of Paclitaxel protein bound particles for injectable suspension, Cyclosporine and other products, which are

currently under approval, in USA.

u Filing more ANDAs / dossiers in USA, Europe and other emerging markets.

u Scaling up the nutrition business by launching new dosage forms and new customer segments

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. During the scal 2023, PBPL has donated to charitable hospitals and Rotary international to support their efforts for providing medical facilities to poor and needy patients.

The Company had, on humanitarian grounds, donated 125,000 doses of its WHO Prequalied Pentavalent vaccine, Easyv e-TT, to the Ministry of Health of Republic of Cuba for use in Cuba National Health System speciocally in the expanded immunization program due to then ongoing shortage of the wP based Pentavalent Vaccine in Cuba. The donation is a small step in the Companys continuous strive for Indian science and capabilities for the benet of all.

Panacea Biotec has, in the memory of Late Shri Soshil Kumar Jain, the founder promoter and former Chairman of the Company, has announced Soshil Kumar Jain, Chairman Panacea Biotec Gold Medal Award which will be given every year to the student of Delhi Pharmaceutical Sciences and

st

Research University (DPSRU) who secures 1 Position in M.Pharm (Biotechnology).

Safety, Health and Environment Protection

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.

We are committed to business practices that promote socially and environmentally responsible economic growth. The EHS policy advocates the provision of safe working environment to all the employees, contractors, sub-contractors, visitors and the neighbouring communities. We continued to make signicant progress on our multi-year plan to move closer to our long-term environment, health and safety ("EHS") vision of Target Zero: zero incidents, zero injuries and zero releases.

Panacea Biotec has also initiated implementation of

Integrated Management Systems across manufacturing facilities at Lalru & Baddi, comprising of ISO 14001: 2015 (Environmental Management System); and ISO 45001: 2018 (Occupational Health & Safety Management System).

Among other things, Panacea Biotec has:

u continued the implementation of EHS management system, which promotes proactive compliance with applicable environment, health and safety requirements, establishes minimum expectations throughout its operations and helps drive continuous improvement in EHS performance;

u provided EHS regulatory surveillance tools for all countries where it has signicant operations;

u proactively evaluated EHS compliance through self- evaluation and an internal audit program, addressing non-conformities through appropriate corrective and preventative action whose progress is tracked; and

u established targets to reduce the environmental impact of its operations, through energy and water conservation, recycling and reuse of waste products;

As part of the auditing procedure, Panacea Biotec recognises and take appropriate steps in the critical areas requiring immediate corrective action, and endeavours to prevent negative health impact on the employees through various health awareness sessions, provision of medical facilities and medical insurance benets .

Note: As a result of rounding o adjustments, the ogures/ percentages in a column in various sections in the Annual Report may not add up to the total for such columns.