Panacea Biotec Ltd Management Discussions

GLOBAL VACCINE MARKET

Vaccines Market Overview

There has been significant progress in the global vaccine industry over the last few decades. Vaccine immunization programs that are run across various countries have saved millions of lives every year. With increased awareness, resounding success of current vaccination programs, and successful model developed by Gavi, the Vaccine Alliance ("Gavi") for adoption and funding, the number of vaccines being targeted are increasing as per the WHO Immunization Agenda 2030 (IAD 2030), Gavi 6.0 and Gavis Vaccine Innovation Prioritisation Strategy (VIPS).

This market encompasses a wide range of vaccines, including those for infectious diseases, chronic conditions, and emerging threats. From childhood immunizations to adult booster shots, vaccines play a crucial role in disease prevention and public health initiatives worldwide. Successful vaccination campaigns globally have driven stronger public trust and reinforced the role of vaccines as essential preventive healthcare tools. Regulatory agencies have prioritized faster review pathways and emergency use authorizations for high-impact vaccines, creating an environment of expedited development and commercialization.

The year 2024 marked the 50 anniversary of the Expanded Programme on Immunization. Over 150 million lives have been saved over these past 50 years and 40% of the reduction in infant deaths globally has been due to vaccination. The global vaccines market was estimated at US$ 86.35 billion in 2024 and is predicted to increase to US$ 91.97 billion in 2025. The market is further expected to increase to approximately US$ 161.40 billion by 2034, expanding at a CAGR of 6.69% from 2025 to 2034.

Top three vaccines by volume were Oral Polio Vaccine (OPV), COVID-19, and seasonal inouenza vaccine. Big volume increases were observed in Human Papillomavirus (HPV) and smallpox / Mpox vaccines.

Vaccines Market Dynamics

Concentration of vaccine manufacturing remains, with 10

manufacturers alone providing ~75% of vaccine doses

(excluding COVID-19 vaccines) and capturing ~85% of the global value of vaccines, with more than 80 manufacturers serving the remaining market. The supply of vaccines for countries in the African and the Eastern Mediterranean regions continues to come from outside the respective regions. Important investments in local production capacity by the regional and international community are ongoing to align with regional goals. Gavis African Vaccine Markets Accelerator (AVMA) being funded with US$1.1 billion is committed to provide funding to build and sustain vaccine manufacturing capacity in Africa. The fund is expected to help procure more than 800 million doses that are partially made in Africa until 2035. The fund will incentivize manufacturers to manufacture Gavis priority antigens either through drug substance or drug product (that include wP-IPV based hexavalent vaccine, measles-rubella vaccine, pneumococcal conjugate vaccine (PCV>13), etc.) through per dose incentives and milestone incentives (on achieving WHO Pre-qualication). Higher milestone incentives are offered for drug substance manufacture on the continent including for pandemic preparedness through platform approaches like viral vector, mRNA, etc. The impact of AVMA is yet to be seen as there are over 29 vaccine manufacturers who have already announced programs in the run up to AVMA launch while only 4 manufacturers have successfully built manufacturing facilities. African manufacturing continues to drive global political agenda and importance, given the vaccine inequalities during COVID-19 pandemic.

In terms of geographical volume share of demand, the SouthEast Asia Region continued to consume ~30% of vaccines globally. The African Region consumed an increasing share (12%) of total volumes in 2022 compared to 2021 (8%). From a value perspective, the Region of the Americas expands the most, driven by high prices and volumes in the USA, followed by the Western Pacic Region where demand is driven by Chinas large volumes. When segmenting the market by income group, vaccines purchased by middle-income countries (MICs) account for 60% of the global volumes and ~34% of the value. High-income countries (HICs) represent 29% of the global volume and 63% of value, driven by vaccines that are higher-priced than those procured by other groups.

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.

Key features of the global vaccine market:

Aggregate global vaccine market volumes in 2023 stabilized at a level similar to pre-COVID, due to reduced procurement of COVID-19 vaccines. The global vaccine markets financial value experienced a larger growth of ~15% CAGR over the past v e years.

The global vaccine market remains highly concentrated between a limited number of manufacturers, with the largest 10 manufacturers accounting for ~75% of vaccine dose volumes and capturing ~85% of global financial value. Manufacturers a liated with the Developing Country Vaccine Manufacturers Network (DCVMN) sold more than 50% of vaccine doses procured globally, representing ~11% of the global financial value.

National stock-outs have remained a problem for many countries, with 68 countries reporting at least one stockout at the national level in 2023.

Countries in the African and Eastern Mediterranean regions continued to procure vaccines manufactured almost entirely outside their respective regions. The South-East Asia region and the Western Pacic region look highly self-su cient, with the former self-supplying ~87% of vaccines procured, and the latter self-supplying ~66% of vaccine procured.

Self-procuring middle-income countries (MICs) represented ~40% of market volumes, followed by pooled procurement initiatives (UNICEF and PAHO), which represented ~36% of globally procured volumes in 2023 with self-procuring high-income countries (HICs) accounting for the remaining ~24% of the volumes.

Globally, vaccine prices have remained relatively stable in the last years.

North America led the market with the largest revenue share of ~43% in 2024. It continues to dominate the global vaccine market due to high healthcare expenditure, robust infrastructure, and extensive vaccination programs. Asia Pacic is projected to expand at the fastest rate during the forecast period of 2025-2034. Factors such as a large population base, rising awareness about preventive healthcare, and improving healthcare infrastructure are

driving the growth of the market in this region.

The recombinant / conjugate / sub-unit segment dominated the vaccines market with the largest share in 2024. Conjugate vaccines are highly effective against bacterial infections, particularly in infants and young children, by coupling a weak antigen with a strong one to enhance immune response. Recombinant vaccines utilize genetic engineering techniques to produce antigens, which are safer and easier to manufacture compared to traditional methods.

The parenteral segment dominated the vaccines market in 2024. The oral segment also has a signicant share of the vaccines market in 2024. Oral vaccines offer several advantages, including ease of administration, non- invasiveness, and enhanced patient compliance, especially in paediatric and resource-limited settings. · The viral disease segment has dominated the vaccine market with the largest revenue share of ~64% in 2024. Inouenza vaccines remained vital in mitigating the annual burden of seasonal ou. With the co-circulation of inouenza viruses alongside the SARS-CoV-2 virus, vaccination against inouenza became even more critical to alleviate strain on healthcare systems and reduce the risk of concurrent COVID-19 and ou infections.

The paediatric segment dominated the vaccines market with the largest share in 2024. In the paediatric vaccine segment, advancements in immunization technology and increased awareness about the importance of childhood vaccinations have led to a surge in demand. The adults segment is expected to show the fastest growth in the vaccines market. Over ~100 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 programs through market and non-market activities including providing funding to different manufacturers for development of vaccines.

By 2017, the global supply of wP-Pentavalent vaccine exceeded 300 million doses annually with total supply estimated at 650 million doses annually. By end 2022, more than 705 million children had been immunised with three doses of Gavi-funded pentavalent vaccine with total procurement of over 2.1 billion doses since its orst introduction.

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 and offered as combination vaccines. High x ed costs and a steep learning curve make new vaccines relatively 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.

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.), creating barriers to entry, and uncertainty regarding commercial 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

Growing Global Demand: Increased awareness of the importance of vaccination can expand market opportunities.

Technological Advancements: Innovations like mRNA technology can lead to development of more effective vaccines.

Combination vaccines: Potential value of a combination vaccine versus co-administration of separate antigens.

Partnership and Collaborations: Collaborating with governments, NGOs and other pharma companies to enhance reach and resources.

Public Health Initiatives: Leveraging global health campaigns to promote vaccination programs.

Value of Combination Vaccines

Panacea Biotec has focussed on development of fully-liquid combination vaccines like Pentavalent and Hexavalent. In this endeavour, the Company had the opportunity to change the global paediatric immunization program twice with launch of EasyFive-TTR in 2005 and EasySixR in 2017.

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-IPV based hexavalent vaccine (rst launched by Panacea Biotec in March 2017 under the brand name, EasySixR) 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.

Stockouts of existing Vaccines

The market continued to witness more than 68 stockouts of essential vaccines across the year in 2023. These were majorly due to procurement, funding, shortage or quality issues. Such shortages continue to incentivize manufacturers to maintain high levels of inventory of vaccines and raw materials to cater to such stockouts to ensure that paediatric immunization programs are not impacted anywhere. Due to COVID-19 related delays, more than 100 million doses of Pentavalent vaccines are now required in 2024 and 2025 to nish catchup immunization programs. Gavi has decided to fully fund these catchup immunizations but with exit of a manufacturer from the market, existing manufacturers are going to be under pressure to meet the tight timelines for vaccine supply.

Opportunities in the Indian Vaccine Market

The Government of India is the single largest buyer of vaccines with procurement being undertaken for more than 25 million babies annually.

Higher local content requirements in Indian tenders continue to offer opportunities for Indian manufacturers to develop and commercialise EPI vaccines for the Indian high-volume but low-value Indian market.

Gavi 5.0/6.0s push for inclusion of more vaccines in the global EPI schedules and Government of Indias new commitments to reduce infant mortality and boost maternal health will continue to provide more opportunities for sustainable market development leveraging existing vaccine platforms.

With Gavi 5.0 (2021-2025), there is a renewed interest in the public market adoption of dengue vaccine. Phase III clinical trials of the Companys candidate tetravalent dengue vaccine, DengiAllR, are ongoing in India. The Gavis proposal to encourage large-scale immunization programs will create a sustainable market for such vaccines 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 oll in the gaps. 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.

Regulatory Hurdles: Stringent and varying regulations across countries can delay market entry.

Competition: Increasing competition from other pharmaceutical companies developing similar vaccines.

Supply Chain Disruptions: Natural disasters, pandemics, or geopolitical issues can disrupt the supply chain.

Adverse Events and Safety Concerns: Reports of adverse events can lead to loss of trust and legal liabilities.

Intellectual Property Disputes: Legal challenges over patents and proprietary technologies.

Indian Vaccine Market

As per industry estimates, the Indian vaccine market was valued at ~ 113.70 billion in 2024 and is estimated to reach 247.00 billion by 2033, exhibiting a CAGR of 8.8% from 2025-2033. Indian vaccine market is driven by the increasing emphasis on preventive healthcare, improved healthcare access, rising public awareness and government immunization programs. Growing demand for a ordable vaccines and advancements in technology are also encouraging innovation and production, enhancing overall vaccine demand across various population segments. Indias biotechnology sector has increased 13-fold over the past decade, from US$ 10 billion (~ 850 billion) in 2014 to over US$ 130 billion (~ 11,100 billion) in 2024 and is expected to reach US$ 300 billion (~ 25,600 billion) by 2030.

A key driver in the Indian vaccine market is the growing focus on preventive healthcare and government of Indias push on Project Indradhanush. With increasing awareness about disease outbreaks and the long-term beneots of immunization, both government and private stakeholders are prioritizing vaccination as a cost-e ective public health tool. The expansion of awareness campaigns, school-based programs, and healthcare worker outreach in rural areas is bolstering the Indian vaccine market growth. Additionally, the rise in lifestyle and infectious diseases has shifted consumer preference towards preventive measures. This change, together with strong government support and improved healthcare infrastructure, is signicantly accelerating vaccine demand across various age groups and socio-economic segments in India.

With one of the worlds largest paediatric populations, routine childhood immunizations remain a cornerstone of healthcare priorities. Simultaneously, an ageing demographic is increasingly vulnerable to diseases like inouenza, pneumococcal infections, and shingles, prompting rising adult and geriatric vaccination needs. Government and private healthcare providers are introducing targeted immunization schedules to address these segments, backed by improved healthcare access and urbanization. This demographic-driven demand ensures consistent consumption across age groups, creating long-term market stability and encouraging new product development tailored to age-specic immunity requirements.

PANACEA BIOTECS BUSINESS AND STRATEGY

Panacea Biotec group continues to focus on its vaccines, pharmaceutical and nutrition business. Vaccines business contributes the largest share in the groups revenues with the remaining coming from pharmaceutical formulations and nutrition products. We believe that we have a strong pipeline and are well positioned for future growth in all the segments. At the heart of Panacea Biotecs strategy lies a deep commitment to Research & Development. Our focus is not only on advancing science but also on making it a ordable, practical, and impactful for families worldwide. By improving e cacy, simplifying dosing regimens, and / or reducing the cost of manufacturing, our R&D efforts ensure that our innovations translate into better access, better outcomes, and healthier lives. We seek to leverage a strong pipeline, organized around expected operational growth drivers to creating long-term growth opportunities.

Building on this foundation, we are now consciously shaping our portfolio around the complete journey of a child. From the earliest stage of life where vaccines safeguard against life-threatening diseases, to early-age nutrition that supports growth and development, and into ongoing healthcare and wellness solutions, Panacea Biotec is creating a continuum of care. This child-centric approach ensures that we remain trusted, and indispensable across multiple stages of a familys health journey.

A critical enabler of this strategy is the trust and equity among

paediatricians, earned over decades through our vaccines and pharmaceutical offerings. This unique positioning allows us to introduce new portfolios seamlessly, with credibility and conodence, reinforcing our role as a partner to both healthcare professionals and parents. By leveraging this strong foundation, Panacea Biotec is well placed to extend into adjacent categories and create a ho listic ecosystem of solutions that strengthens our engagement with consumers over time.

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 initiatives. 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 continue to consider business development activities that will help advance our business strategy.

Panacea Biotecs Vaccine Business

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 more than 200 million immunizations by supplying fully liquid wP based combination vaccines. 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 believe that the following are our key strengths:

Advanced Research and Development Capabilities: Strong R&D teams and state-of-the-art laboratories enable the development of innovative vaccines.

Strong Regulatory Knowledge: Expertise in navigating complex regulatory environments to secure approvals.

Robust Supply Chain: E cient manufacturing and distribution networks ensure timely delivery of vaccines.

Established Brand and Reputation: Trusted by healthcare providers and the public, leading to higher acceptance rates.

Intellectual Property: Patents and proprietary technologies provide a competitive edge.

Journey marked by Polio eradication leading to bigger

impact across infectious diseases

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, NuCoVacR-11 a pneumococcal polysaccharide conjugate vaccine (11-valent), a multi-epitope nanoparticle based broadly protective Betacoronavirus candidate vaccine and several other vaccines at various stages of development.

Our paediatric vaccine franchise focuses on providing newborns protection against deadly diseases like diphtheria, tetanus toxoid, B. pertussis, hepatitis B, haemophilus inuenza Type b (Hib), and polio. 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, EasySixR (DTwP-HepB-Hib-IPV)

Worlds first fully liquid wP-IPV based pentavalent vaccine, EasyFourPolR (DTwP-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.

During the onancial year 2024-25, total consolidated revenues from vaccines business was 3,098.43 million as against 3,595.90 million in the previous financial year. The revenue from export of vaccines was 2,169.37 million (~70%) as against 3,158.21 million during previous year.

The existing commercialized product portfolio of the Company includes key proprietary vaccines, hexavalent vaccine EasySixR, fully-liquid pentavalent vaccine, EasyFourPolR, fully-liquid tetravalent vaccine, Easyfour-TTR, WHO prequalioed fully-liquid pentavalent vaccine Easyv e-TTR, and bivalent poliomyelitis vaccine Bi-OPVR.

About Easy ve-TTR

Easyove-TTR is the worlds orst fully liquid wP-based Pentavalent vaccine that was launched in India in 2005. After receiving WHO pre-qualication in 2008, more than 200 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 centres, and

reduces the overall cost of immunization for all stakeholders.

About EasySixR and EasyFourPolR

Panacea Biotec is the innovator and intellectual property holder of EasySixR, the worlds first fully-liquid hexavalent vaccine. The WHOs Strategic Advisory Group of Experts on Immunization (SAGE) has supported the global rollout of wP-IPV 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.

In India, the Company has a eld force of around 150 persons spread across the country to regularly reach out to nearly 10,000 paediatricians across India. Over 400,000 children are vaccinated in the private market in India. EasySixR is the brand leader in India with the largest market share in its segment (IQVIA March 2024). The wP-IPV based hexavalent vaccines also competes with aP-IPV based vaccines in the private market in India.

During financial year 2023-24, Panacea Biotec also launched the worlds first fully-liquid wP-IPV based pentavalent vaccine under brand name of EasyFourPolR which provides protection against diphtheria, tetanus toxoid, B. pertussis, Hib, and polio. It is the only vaccine in its segment of wP-IPV based vaccine and that aids healthcare practitioners who prefer to give hepatitis B as a standalone vaccine or in mixed schedules due to high-risk births.

Our combination vaccines led by EasySixR, EasyFourPolR, and Easyove-TTR also set the precedent of promoting environmental sustainability. Adoption of EasySixR in the immunization program leads to reduction of over 60% carbon emissions, helps make a single immunisation program (3 vs. 1), over 50% reduction in supply chain costs and storage beneots, and also more than 50% reduction in biological waste.

CO emissions for 30 million doses (in kg)	Current immunisation schedule	EasySixR
	(3 Penta and 3 IPV)
Paper	7,988,775	3,195,510
Glass	225,721	90,288
Steel	4,625	1,850
Transportation	8,707,455	3,482,982
Total for 30 million doses	16,926,576	6,770,630

Apart from lower number of injections and less pain for children, EasySixR provides additional benets to parents and governments. As parents are able to get all the vaccinations completed in fewer visits, they are more likely to get their children vaccinated. With higher vaccination rates, governments have to spend less money to create healthcare infrastructure and doctors / nurses spend less time on treating avoidable diseases among children; families also get benet ed as they truly spend their income to improve their quality of life. Hence, overall society benets from critical combination vaccines like EasySixR.

Considering the benets that EasySixR offers, WHO SAGE in October 2021 approved adoption of hexavalent vaccine in the global immunization program. This led to PAHOs adoption in May 2023 and Gavis adoption in June 2023. Further, UNICEF has already updated its forecast for hexavalent vaccines as stated below:

(No. in million doses)

UNICEF forecast	2024	2025	2026	2027	2028	2029	2030	Total
Gavi-73	3	19	44	71	97	105	107	446
Gavi-64	3	19	41	60	83	90	90	385

Giving further impetus to hexavalent vaccine adoption, Gavi has also given its preference to introduce a fourth dose for every child in the second year of life - this will replace the ongoing commitment for adoption of a DTP based booster in the second year of life.

Pipeline vaccines

The Company is in the process of launching TedShotR (Tetanus and Diphtheria reduced) vaccine in India after having received marketing authorisation in India. We expect it to compete in the annual 250 million private market in India and the public market procurement.

The Phase III clinical trial for Indias first dengue vaccine, DengiAllR and Phase II / III clinical trial for NuCoVacR11 vaccines are ongoing in India. The Company has collaborated with Indian Council of Medical Research (ICMR) for the Phase III clinical trial of DengiAllR vaccine.

The Company is also developing a multi-epitope recombinant

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Mpox vaccine, VaxiPox designed against highly conserved antigens across Mpox clades, jointly with BRIC-THSTI. A recombinant, nanoparticle broadly protective betacoronavirus candidate vaccine is being developed in collaboration with BRIC-THSTI.

About DengiAllR

Panacea Biotecs tetravalent dengue vaccine candidate, DengiAllR has been developed to provide balanced protection across all four dengue virus serotypes while ensuring a superior safety proole compared to existing options. One of the major challenges in dengue vaccine development has been the risk of antibody-dependent enhancement (ADE), which can lead to more severe disease in individuals without prior dengue exposure. This has been a recurring safety concern with earlier and some current vaccines, where e cacy against certain serotypes was inconsistent.

In fact, long-term analyses of competing products (Daniels et al (Nat Med 31)) have shown that while protection was achieved for DENV1 and DENV2, there was little to no e cacy against DENV3 and DENV4 in seronegative individuals. Moreover, imbalances were observed in hospitalization rates for DENV3, with the vaccine arm showing more cases than placebo, and regulatory reviews have highlighted the risk of hospitalization and severe dengue-including dengue haemorrhagic fever - linked to DENV3 and DENV4 in dengue-naive recipients.

DengiAllR has been designed to overcome these limitations by avoiding structural imbalances that contribute to serotype-specic risks. Its safety advantage is reinforced by both human challenge and non-human primate studies, where DengiAllRs strains have demonstrated robust protection. In controlled human infection models, vaccinated volunteers resisted wild-type dengue challenge, showing prevention of both viremia and symptomatic illness across all four serotypes without evidence of breakthrough severe cases. Similarly, monkey challenge studies conrmed that vaccinated animals mounted strong neutralizing antibody responses, were protected from clinical illness, and did not experience ADE-associated complications.

Together, these findings position DengiAllR as a safer and more programmatically deployable dengue vaccine candidate, with the potential to eliminate the need for pre-vaccination screening. By combining a broad tetravalent response with early evidence of durable safety from challenge studies, DengiAllR stands out as a next-generation solution capable of addressing the global unmet need for a reliable dengue vaccine.

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About Mpox candidate vaccine VaxiPox

Mpox, caused by the Monkeypox virus (MPXV), has re-emerged as a signiocant global health concern with multiple clades in circulation. Clade I (Central African, further divided into Ia and Ib) is associated with more severe disease and higher fatality rates, while Clade II (West African, with subclades IIa and IIb) has been responsible for the widespread outbreaks since 2022. The ongoing circulation of both severe and milder clades highlights the unpredictable nature of the disease and the potential for further international spread. A major clinical challenge lies in the waning immunity resulting from the cessation of smallpox vaccination programs after eradication in 1980. While older populations may retain partial cross-protection, younger generations are largely susceptible, leaving a growing global immunological gap. This has been compounded by new epidemiological patterns of transmission, including household spread, nosocomial infections, and sexual networks, which have accelerated the diseases reach across continents.

Against this backdrop, Panacea Biotec, in collaboration with

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BRIC-THSTI, is developing VaxiPox , a novel multi-epitope

subunit vaccine designed to target conserved antigens across

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circulating clades. Unlike live-virus vaccines, VaxiPox offers a safer proole suitable for wider populations, including immunocompromised individuals and children, while eliciting both strong T-cell and neutralizing antibody responses. With global Mpox cases surpassing 142,000 conrmed infections across more than 120 countries by April 2025, the demand for effective, broadly protective vaccines has never been more pressing. The global Mpox vaccine market, valued at approximately US$ 1.2 billion in 2024, is

projected to reach nearly US$ 2.5 billion by 2033, growing at a

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CAGR of over 8%. VaxiPox is well-positioned to address this unmet need, combining scientic innovation with scalable production to ensure accessibility in both developed and resource-limited regions.

About Broadly protective Betacoronavirus candidate

vaccine

A recombinant nanoparticle candidate vaccine, being collaboratively developed with BRIC-THSTI, has potential to offer protection against SARS-CoV-1, SARS-CoV-2 and MERS to drive broad neutralization. This candidate vaccine is formulated with Panaceas EmulsiPan adjuvant. The program is co-funded by CEPI (US$12.5 million) and is advancing towards Phase I human safety studies.

Betacoronaviruses have emerged repeatedly in recent decades, underlining the urgent need for broadly protective vaccines. The SARS-CoV-1 outbreak in 2001 (commonly referred to as the 2002 2003 SARS pandemic) demonstrated how a novel coronavirus could spread rapidly across continents, resulting in over 8,000 cases with nearly 10% fatality. This was followed by the SARS-CoV-2 pandemic in 2019, which escalated into the most disruptive global health crisis in recent history, infecting hundreds of millions, causing millions of deaths, and leaving long-lasting socio-economic impacts worldwide. Parallel to these, Middle East Respiratory Syndrome (MERS) - first identied in 2012 - has continued to pose a persistent threat, especially in Saudi Arabia. By May 2025, there have been 2,626 conrmed cases globally, of which more than 2,217 were reported in Saudi Arabia alone, with a case fatality rate close to 39%. These repeated incursions underscore the unpredictability and high lethality of betacoronaviruses.

India, like several other countries, faces a heightened vulnerability due to animal reservoirs and environmental interfaces. Dromedary camels are recognized carriers of MERS-CoV, and multiple coronavirus strains have also been identied in Indian bat populations. The close human animal proximity that characterizes large parts of India - driven by livestock dependence, expanding urban encroachment, and ecological disruption - further elevates the risk of zoonotic spillovers. In conic t-prone or resource-constrained regions, surveillance and containment are even more di cult, compounding the risk of localized outbreaks escalating into wider epidemics.

Together, these initiatives highlight how Indias scientioc partnerships are producing globally relevant vaccine solutions. With rising risks from coronaviruses, poxviruses, and other zoonoses, platforms that combine antigenic breadth, rapid manufacturability, and a ordability are poised to become cornerstones of global pandemic security.

Global Institutional business for Vaccines

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. During the year under review, the Companys vaccines were exported to ~30 countries in Africa, Asia and Latin America. As part of the Companys strategy to enter into the international private vaccine market, the Company has already registered its vaccines in 16 countries (including African Medicines Regulatory Harmonization (AMRH) which will inter-alia enable launch of product in ~29 countries in African region who have ratied the African Medicines Agreement (AMA)).

The product registration in 17 countries is in progress and is

expected to be approved in due course.

The Companys EasySixR vaccine has been listed as the first product under the Continental Listing of Human Medicinal Products by the AMA as part of the AMRH initiative. This continental listing is designed to facilitate accelerated registration of listed products across AMRH member countries.

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

Panaceas marketed / market-ready vaccines viz. pentavalent, pneumococcal conjugate and tetanus and diphtheria reduced etc. are expected to cover over 46% of the Gavis demand (in doses) until 2030. Overall, over 131 countries use DTwP-based combination vaccines (Easyv e-TTR and EasySixR compete in this segment), over 179 countries use the tetanus containing vaccines (TedShotR will compete in this segment), 130 countries use oral polio vaccines, and over 179 countries are using the pneumococcal conjugate vaccine (NuCoVacR11 vaccine will compete in this segment) in their immunisation schedule.

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, Gates Foundation 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.

Our Role in Polio Eradication

The Company has delivered over 10.5 billion doses of polio vaccines across the world. We started this journey in India in 1990 and then subsequently touched more than 1 billion doses supplied in 2007 - the largest in the world at the time. Worlds first monovalent oral polio vaccines (mOPVs) and bivalent oral polio vaccine (bOPV with Poliovirus Type 1 and Type 3), Bi-OPVR: Anticipating stagnancy in the number of polio cases in 2005, Panacea Biotec launched monovalent OPV vaccines to help arrest the number of polio cases and nally , reach 0 cases in 2011 that we celebrate even today.

GLOBAL PHARMACEUTICAL MARKET

The global pharmaceutical market is poised for robust growth, with projections showing worldwide prescription drug sales exceeding US$ 1.75 trillion by 2030. This represents a CAGR of over 7%, demonstrating signiocant resilience against headwinds such as volatile global tari s, US regulatory uncertainty, and potential pressure on US drug pricing.

The increase in sedentary jobs, busy lifestyles, and evolving consumer preferences is impacting the global disease landscape, particularly the prevalence of non-communicable diseases such as cancer, diabetes and cardiovascular conditions. Factors such as prolonged working hours, reduced physical activity and unhealthy dietary habits contribute signicantly to chronic diseases such as diabetes. Geographically, the market continues to be dominated by North America, which commands over 40% of the global share, largely due to the United States high healthcare expenditure and robust R&D ecosystem. However, the primary engine of future growth is unequivocally the Asia-Pacic region. Fuelled by demographic tailwinds, expanding healthcare access, and a burgeoning local innovation landscape, this region is projected to exhibit the fastest growth, fundamentally altering the global strategic map.

The most critical dynamic within the industry is a fundamental shift in the nature of therapeutic intervention. The market is moving from a traditional small-molecule, one-size-ts-all model towards an era of High-Science, High-Speciocity Medicine. This is dened by 3 interconnected trends: the ascendancy of biologics and advanced modalities like cell and gene therapy; the rise of personalized medicine, enabled by a booming companion diagnostics market; and the strategic focus on orphan drugs for rare diseases. These high-value segments are now the principal drivers of innovation and growth.

This therapeutic evolution is enabled and accelerated by a concurrent technological revolution. The pervasive integration of Articial Intelligence (AI) and machine learning is revolutionizing R&D, from de novo drug design to the optimization of clinical trials. Economically, the industry continues to operate within a powerful cycle of innovation, patent exclusivity, and generic / biosimilar competition. The patent cli remains a formidable strategic challenge, creating a relentless imperative for pipeline replenishment that fuels a dynamic merger & amalgamation landscape. The strategic focus of this activity has shifted towards acquiring innovative, long-term platform technologies rather than immediate revenue streams. In conclusion, the pharmaceutical industry is evolving into a more complex, technologically advanced, and economically nuanced ecosystem. Success in this new era will demand more than scientic excellence alone; it will require mastery of data, global operational agility, and the ability to orchestrate complex partnerships across the healthcare and technology sectors.

Indian Pharmaceutical Market

The pharmaceutical industry in India is a signicant part of the nations foreign trade and offers lucrative potential for investors. Millions of people around the world receive a ordable and inexpensive generic medications from India, which also runs a sizable number of plants that adhere to Good Manufacturing Practices (GMP) standards set by the World Health Organization (WHO) and the United States Food and Drug Administration (USFDA).

The Indian pharmaceutical market, valued at approximately US$61 billion (~ 5,200 billion) in 2024, is projected to reach US$174.31 billion(~ 14,900 billion) by 2033, growing at a CAGR of 11.32% from 2025 to 2033. India is the largest global provider of generic medicines, supplying 20% by volume, and a leader in vaccine production, accounting for 60% of global output. Key segments of the Indian pharmaceutical industry are OTC medicines, generics, active pharmaceutical ingredients (APIs), vaccines, biosimilar and custom research manufacturing (CRM). Ranking third globally in drug and pharmaceutical production by volume, India exports to approximately 200 countries and territories.The top ove destinations for these exports are the USA, Europe, South Africa, Brazil and CIS countries.

The country has an established domestic pharmaceutical

industry, with a strong network of ~3,000 pharmaceutical