Gland Pharma Ltd Management Discussions

Management Discussion and Analysis

Economic Overview Global economic review

The global economy experienced moderate growth of 3.3% in 2024, indicating a period of relative stability with ongoing growth constraints. In 2025, nations are adjusting policies due to increasing geopolitical tensions and economic pressures. The United States introduction of new tariff measures triggered immediate and forceful responses from several nations, culminating in the establishment of near-universal tariffs on April 2, 2025, which consequently escalated to unprecedented levels, exerting significant pressure on global GDP. As the situation continues to evolve, the broader economic impact remains uncertain and is likely to persist as an overhang on the global growth outlook.

These situations have significantly amplified economic uncertainty and rendered the short-term outlook highly volatile. The trustworthiness of conventional forecasting models has been compromised, making it increasingly difficult to anchor estimates to previously reliable assumptions. In this environment of heightened instability, global headline inflation is projected to moderate more slowly than previously anticipated, with expectations now indicating a decline to 4.3% in 2025 and further easing to 3.6% in 2026. The revision largely reflects upward adjustments in inflation projections for advanced economies*, somewhat offset by marginal downward revisions for emerging markets and developing nations.

Despite the uncertainties, the current landscape presents a crucial opportunity to strengthen resilience and steer the global economy towards a more sustainable and inclusive future. Many economies have also shown remarkable adaptability, underscoring that recovery is attainable through proactive reforms, robust institutions, and coordinated policy initiatives. Achieving a fairer and more balanced global recovery will require a collective commitment to fostering transparent trade practices, enabling timely debt resolution, and addressing structural imbalances

Looking ahead, international collaboration will be pivotal Through aligned strategies, visionary leadership, and a shared resolve to navigate complex challenges, the global economy can regain its momentum, rebuild critical buffers, and unlock new avenues forsustained and inclusive growth.

Source: International Monetary Fund, April 2025

*The International Monetary Fund (IMF) defines advanced economies as those with high per capita income, a high degree of industrialisation, diversified exports, and a well-integrated financial sector.

Indias economic landscape

Projected to expand by 6.5% in FY 2024-25, Indias economy reflects the countrys resilience amid an increasingly volatile global environment. This outlook is anchored by strong domestic fundamentals, sustained structural reforms, accelerating digital transformation, and a continued focus on infrastructure development. Agriculture and services sectors have remained key contributors, supported by steady private consumption and enduring macroeconomic stability.

Manufacturing sector growth is expected to moderate to 6.2% in FY 2024-25, easing from 9.5% in the previous year, largely due to a mix of factors including the softening of manufacturing exports amid sluggish overseas demand and rising protectionism. Despite these challenges, Indias macroeconomic fundamentals remain resilient, underpinned by fiscal discipline, a strong external balance, a surplus in services trade, and healthy remittance inflows.

Indias external sector continues to demonstrate resilience. Notably, in the April-December 2024 period, overall exports grew by 6.0% year-on-year, led by a robust surge in services exports. India has now emerged as the seventh-largest contributor to global services trade, reflecting its growing competitiveness and strategic positioning. The positive contribution of net exports to real GDP growth highlights the effectiveness of coordinated macroeconomic measures encompassing inflation management, fiscal prudence, and timely monetary interventions.

The rise of Artificial Intelligence (Al) is reshaping Indias business environment, offering both opportunities and challenges. Subsequently, Al-driven transformation across industries is enhancing productivity and redefining workforce capabilities. Indias young, adaptable labour force is well-positioned to capitalise on this shift, provided that skilling efforts keep pace with technological advancements Government initiatives focused on skilling, digital literacy, and job generation are aligning well with the demands of an Al-led economy.

The Reserve Bank of Indias Monetary Policy Committee cut the repo rate for the first time in two years to boost job creation and growth, a move facilitated by lower retail inflation. Amid global tariff pressures and rupee volatility, the MPC maintained a neutral stance, balancing inflation control and economic momentum.

As India moves into FY 2025-26, the economic outlook remains broadly balanced, although external risks such as geopolitical tensions, trade disruptions, and commodity price volatility persist. Domestically, sustaining private investment, bolstering consumer confidence, and accelerating wage growth will be critical to maintaining momentum. Rural demand is expected to strengthen, supported by an agricultural recovery, easing food inflation, and continued macroeconomic stability. To reinforce medium-term growth prospects, India must deepen structural reforms, rationalise grassroots regulations, and create a more business-friendly ecosystem. These efforts will be vital in enhancing competitiveness, building resilience against external shocks, and sustaining long-term economic progress.

Source: Economic Survey

Industry review

Global pharmaceutical industry

The global pharmaceutical industry continues to experience steady growth, supported by rising healthcare demands across populations. A key driver of this expansion is the aging global population, which increasingly requires longterm medical care for age-related health conditions. This demographic shift is reshaping the industry landscape, spurring continuous innovation, intensified R&D efforts, and increased capital investment across the value chain.

According to IQVIA, the pharmaceutical market is projected to grow at a compound annual growth rate (CAGR) of 6-9%, reaching between US$2.23 trillion and US$2.25 trillion by 2028. This upward momentum is largely driven by the launch of innovative therapeutics and biologies. However, growth is expected to moderate over the next few years as a wave of major patent expirations and the rapid adoption of biosimilars and generics begin to influence market dynamics. Traditionally, new medicine revenues peaked shortly after launch, but today, there is a growing trend of sustained value generation from older therapies. Moreover, the shift toward higher-cost treatments reflects expanded patient access and the rising demand for clinically advanced healthcare solutions.

Therapy area concentration is also intensifying, with oncology, immunology, and obesity treatments together contributing 42% to global sales. Notably, anti-obesity medications are rapidly gaining momentum as a major growth category. Growth in 2024 has been particularly fueled by specialty biologies, which are becoming increasingly central to treatment paradigms. Geographically, the United States and the European Union dominate the industry landscape, together accounting for 67% of global pharmaceutical sales.

Regional spending patterns reflect significant differences based on economic capacity and healthcare policy frameworks. Developed markets continue to spend heavily on patented and branded drugs, underpinned by strong intellectual property protections and robust healthcare budgets. Meanwhile, emerging and lower- income economies largely rely on cost-effective solutions such as generics and branded generics. Following patent expirations, developed economies typically pivoted toward greater generic uptake to control drug expenditures, while emerging markets maintain a strong dependence on generics and non-originator brands to ensure affordable and widespread access to essential medicines.

Global pharmaceutical market growth

		(US$ billion)
Region	2028	2024-2028 CAGR
Developed	1,775-1,805	5-8%
Pharmerging	400-430	10-13%
Lower income	33-37	3-6%
countries Global	2,225-2,255	6-9%

Source IQVIA Market Prognosis, September 2023, IQVIA Institute, December 2023

*Pharmerging refers to fast-growing pharmaceutical markets in developing countries, driven by economic growth, evolving healthcare needs, and better healthcare infrastructure.

Geography-wise market review

Spending growth globally and in 9 regions, total market excluding COVID-19 vaccines and therapeutics, constant US$ 2019-2028

Evolving dynamics in global pharmaceutical spending: In North America, pharmaceutical spending is projected to grow by 6-9% through 2028, driven by a steady influx of new product launches and the continued resilience of established brands. However, this momentum will be partially offset by the impact of upcoming patent expirations.

In the U.S., medicine spending is projected to rise 2-5%, primarily driven by increased spending on branded therapies. The Inflation Reduction Act (IRA) is expected to further increase off-invoice discounts and rebates, with actual spending estimated to be 37% below invoice levels in 2023 and potentially declining to 47% by 2028. Oncology, immunology, diabetes, and obesity treatments continue to show strong growth, though the upcoming loss of exclusivity in immunology may moderate spending. Overall, the outlook will be shaped by new therapy launches and increased competition from generics and biosimilars.

Medicine use grew notably in 2024, reflecting broader treatment access for chronic conditions and new therapies. Total prescription usage increased by 1.7%, reaching 215 billion days of therapy, with record-high Medicare beneficiary use. This growth highlights progress in care access but also persistent challenges, as high out-of-pocket costs and restrictive insurance designs still prevent many patients from filling prescriptions, especially for newer therapies.

Early IRA phases have eased this burden, with fewer Medicare patients paying over US$3,500 annually out-of-pocket and insulin expenses falling due to the US$35 monthly cap. However, over half of new prescriptions for innovative medicines remain unfilled due to affordability. Spending trends reflect these dynamics: net market spending rose 11.4% in 2024, up from 4.9% the prior year, primarily due to greater use of high-impact therapies in diabetes and obesity, rather than price inflation. Consequently, these treatments wider adoption is reshaping pharmaceutical care economics. This report presents a revised five-year outlook, capturing the evolving balance of innovation, access, and affordability in the U.S. medicine landscape

In Western Europe, pharmaceutical spending grew 8% until 2023. However, growth is projected to slow to 4-7% through 2028 due to payer pressures and patent expirations, though innovative therapies may partially offset this.

Eastern Europe is projected to lead global growth with a CAGR of 7.5-10.5%, remaining a strong performer despite potentially easing momentum.

In Latin America, spending spiked during the early pandemic years, driven by heightened demand for generic and established therapies to manage COVID-19 symptoms. Following a subdued 2024, the region is expected to return to a healthy growth trajectory, with an average CAGR of 7-10%, led by key markets such as Brazil, Mexico, Argentina, and Colombia.

In Japan, growth is expected to remain flat to slightly negative, ranging between -2% and 1% annually. Despite the increased uptake of innovative branded therapies, the shift from biennial to annual price revisions is exerting downward pressure on spending, contributing to market stability.

The China pharmaceutical market is projected to stabilise over the next few years, following significant fluctuations during the pandemic amid stringent public health measures.

Pharmaceutical spending is expected to grow at a moderate pace of 2-5% through 2028, reflecting gradual policy normalisation and evolving market dynamics.

Market trends across key therapeutic segments

Oncology

The global oncology market reached approximately US$244 billion in 2024. Growth in haematology, particularly blood cancers, outpaced that of solid tumors during the year, partly driven by the diminishing impact of the lenalidomide patent expiry. Despite this, solid tumors continue to dominate in absolute market value. Breast cancer and non-small cell lung cancer lead overall sales and are expected to accelerate further in the coming years. Biologies accounted for 51% of the total global oncology market value in 2024, with innovative molecules driving much of the 2023-2024 value growth. Notably, checkpoint inhibitors contributed 54% of the innovative biologics growth during this period, underscoring their critical role in advancing oncology therapeutics

Immunology

The global immunology market stood at around US$200 billion in 2024. It is generally segmented into allergic inflammation and autoimmune conditions, with allergic inflammation exhibiting faster growth momentum. Within the autoimmune segment, IL-23 inhibitors are leading the treatment landscape for psoriasis, while new IL-17 therapies, oral treatments, and topical formulations are entering the market. Simultaneously, the arrival of major biosimilars such as Adalimumab and Ustekinumab is poised to gradually erode the value of originator biologies, intensifying competition and reshaping the market dynamics

Obesity

Obesity has emerged as a major global health crisis, with projections indicating that nearly 2 billion people could be affected by 2035, representing about 25% of the worlds population. Anti-obesity medications have gained significant traction, demonstrating weight loss outcomes comparable to those achieved through bariatric surgery. The obesity treatment market is expected to grow significantly through 2028, fueled by increasing complexity and competition as more players enter the field. Despite this momentum, the market remains in its early stages of development, presenting opportunities for innovation and expansion.

Biosimilars

Biosimilar adoption typically follows a steady upward curve in European markets, with notable uptake within the first couple of years. While the U.S. market tends to adopt more gradually, it has shown the capacity to accelerate, as evidenced by recent biosimilar launches. In the small- molecule generics space, key therapeutic areas include pain management, antibacterials, and antihypertensives. Generic utilisation continues to grow across major markets, with further headroom for expansion, especially in Europe, where supportive policy measures could unlock broader access.

Loss of Exclusivity (LOE) and market opportunities

LOE marks the expiry of patent protection for branded drugs, thus enabling generic and biosimilar competition Between 2025 and 2035, around 75 high-value molecules with combined U.S. sales exceeding US$300 billion are set to lose exclusivity, unlocking significant market opportunities

The impact is concentrated in high-growth therapy areas such as diabetes, oncology, HIV, psoriasis, and obesity. Of the 74 molecules identified, 30 are biologies, including major blockbusters like Semaglutide and Pembrolizumab Over 56 of these products fall into the US$l-5 billion sales range, offering strong potential for generic and biosimilar makers

Regional LOE timelines across the U.S., EU5 (France, Germany, Italy, Spain, and the United Kingdom), Japan, and China enable phased market entries. Injectables account for 45% of LOE value, highlighting scope for formulation-led innovation in vials, pre-filled syringes, and biosimilars

The LOE cycle presents a structural growth lever for companies with strengths in complex generics, biosimilars, and regulatory execution. Timely readiness across manufacturing, compliance, and market access is crucial to unlocking this multi-billion-dollar opportunity

Global injectables industry

The global injectable drug delivery devices market is projected to grow from US$565 billion in 2025 to approximately US$1,217 billion by 2034, at a CAGR of 8.9%. This growth is driven by factors such as the increasing prevalence of chronic diseases, rising demand for selfadministration devices, and technological advancements in drug delivery systems. North America held the largest market share of 40.5% in 2024, while the Asia-Pacific region is expected to experience the fastest growth during the forecast period.

Key trends include the dominance of large-molecule biologies, rapid expansion of biosimilars post-patent expires, and rising adoption of specialty injectables for complex conditions. Challenges such as stringent regulatory compliance, supply chain vulnerabilities, pricing pressures, and the need for advanced cold chain logistics persist. However, opportunities in emerging markets, technological advancements in delivery devices, and growing demand for at-home and self-administered treatments are expected to further accelerate industry growth over the next five years. Source: GlobeNewswire

Key growth drivers in the injectable drug delivery market

Rising prevalence of chronic diseases: The global surge in chronic illnesses such as diabetes, cancer, and autoimmune disorders is significantly boosting the demand for injectable therapies, which are often central to effective disease management.

Aging population fueling demand: The worlds aging population is a major contributor to the growing use of injectable therapies. Older adults are more prone to chronic and degenerative conditions requiring consistent and effective treatment regimens, many of which are administered through injectables

Expanding role of biologies:

The pharmaceutical landscape is witnessing robust growth in biologies, particularly injectable formats like prefilled syringes, which offer improved safety, precision, and ease of use. With patents for several blockbuster biologies nearing expiry, the demand for injectable delivery devices tailored to biosimilars is poised to surge, creating significant opportunities for manufacturers.

Technological advancements in drug delivery:

Innovations such as finer needles, needle-free injectors, and smart delivery systems are enhancing patient adherence, minimising discomfort, and improving therapeutic outcomes. These advancements are accelerating market adoption by making injectable treatments more patientcentric and accessible.

Patent expirations creating generic opportunities:

The expiration of patents for several high-value injectable drugs is paving the way for generics and biosimilars. This shift is intensifying competition, improving affordability, and expanding access, particularly in emerging markets with rising healthcare needs.

Advancements in New Drug Delivery Systems (NDDS):

The development of next-generation injectable devices such as autoinjectors, pen injectors, and prefilled syringes has transformed self-administration practices.

Emerging therapeutic opportunities: Pharmaceutical companies are actively investing in complex injectable therapies targeting conditions such as rheumatoid arthritis, multiple sclerosis, various cancers, and other autoimmune diseases.

Global generic injectables industry

The global generic injectable market is experiencing robust growth, with projections indicating a rise from US$ 135.4 billion in 2025 to US$ 401.8 billion by 2035, reflecting a compound annual growth rate (CAGR) of 11.5%. Key growth drivers include patent expirations, rising demand for affordable treatments, and the increasing prevalence of chronic diseases. North America leads the market, while Asia-Pacific is the fastest-growing region. Oncology remains the largest therapeutic area, supported by the broader adoption of generic cancer treatments. Technological advancements like prefilled syringes and supportive regulatory environments are boosting market expansion.

Source: GlobeNewswire

Contract Development and Manufacturing (CDMO) services for biologies

Biologies Contract Development and Manufacturing Organizations (CDMOs) have become indispensable partners in the biopharmaceutical industry, providing integrated, end-to-end solutions that span early-stage development to commercial-scale manufacturing. These organisations provide critical services such as regulatory support, analytical testing, formulation development, and packaging enabling pharmaceutical companies to accelerate the development and market launch of biologic therapies.

The surge in R&D investments, coupled with an increased focus on rapid drug commercialisation by leading pharmaceutical players, has significantly amplified the demand for biologies CDMOs. By offering specialised expertise and operational flexibility, CDMOs allow biopharma companies to navigate complex regulatory frameworks and scale production efficiently, while minimising risk and optimising time-to-market.

With deepening technical capabilities and fully integrated service models, CDMOs are no longer just vendors but strategic partners across the biopharma value chain. Their offerings now encompass the entire spectrum from drug discovery and clinical development to commercial manufacturing addressing the industrys evolving needs for speed, scalability, and specialisation. Reflecting this growing strategic importance, the global biologies CDMO market is experiencing strong momentum. Market revenues are projected to rise from US$ 17.1 billion in 2024 to US$ 38.1 billion by 2030, representing a robust CAGR of 11.0% over the forecast period.

About Gland

Established in 1978 in Hyderabad, India, Gland Pharma Limited (Gland) has evolved into a prominent entity in the global generic injectables market, with operations extending to over 60 countries including the United States, Europe, Canada, Australia, and India. Primarily functioning under a B2B model, the company provides comprehensive services such as contract development, dossier compilation, technology transfer, and manufacturing across various delivery systems.

Over the past four decades, Gland has built a strong reputation for excellence in R&D, manufacturing, and marketing of generic injectables. The company continues to evolve, now expanding into complex injectables and biologics/biosimilar contract development and manufacturing (CDMO). Guided by a commitment to quality and affordability, Gland strives to meet diverse global needs through a wide portfolio of high-quality injectable products.

Leveraging its R&D capabilities in synthesising complex molecules, the company has successfully developed niche products across a broad range of therapeutic areas. It is particularly recognised for its expertise in sterile injectables, oncology, and ophthalmic products, offering delivery formats such as liquid vials, lyophilised vials, pre-filled syringes, ampoules, bags, and Eye Drops.

A key strategic milestone was the seamless integration of its first overseas acquisition Cenexi through its wholly owned subsidiary, Gland Pharma International Pte Ltd Cenexi, a well-recognised European CDMO, brings significant expertise in sterile liquid and lyophilised fill-finish formulations, including complex oncology products. This acquisition aligns with Glands longterm strategy to establish a manufacturing footprint in Europe and expand its CDMO offerings in the branded CDMO segment.

By leveraging Cenexis technological capabilities such as needleless injectors, oncology pre-filled syringes, hormonal and controlled substances, ophthalmic gels, Gland Pharma is strengthening its product offerings and expanding its reach, including the drug product fill-finish services for biologies, vaccines, and biosimilars.

Gland Pharma is actively focusing its efforts and investments on revitalising Cenexi, with the strategic objective of transforming it into a globally recognised CDMO leader. The Company is strategically allocating financial, technological, and human resources to upgrading Cenexis infrastructure, enhancing its operational efficiencies, and fostering a culture of quality

Pipeline dashboards

Complex injectables portfolio by therapeutic area

Therapeutic area	No. of products	As % of Total	TAM (US$ mn)	as % of TAM
Oncology	4	21%	1,203	18%
Immunology	2	11%	262	4%
Diabetes management	3	16%	1,069	16%
Reproductive Health	2	11%	113	2%
Cardiology	3	16%	70	1%
CNS Health	2	11%	3,095	47%
Chemo-adjuvants	1	5%	174	3%
Bone Health	1	5%	76	1%
Addiction management	1	5%	511	8%
	19	100%	6,573

Total Addressable Market (TAM)  All values in US$, TAM as of March 2025, as analysed by the Company

Current TAM of complex injectables and estimated launches

							(TAM US$ mn)
Therapeutic area	CY23A	CY24A	CY25E	CY26E	CY27E	CY28Eand beyond	Total
CNS Health	-	-	-	-	-	3,095	3,095
Oncology	14	88	73	-	-	1,027	1,203
Diabetes management	31	-	-	-	-	1,038	1,069
Addiction management	-	-	-	-	-	511	511
Immunology	-	-	-	87	-	175	262
Chemo-adjuvants	-	-	-	-	-	174	174
Reproductive Health	-	113	-	-	-	-	113
Bone Health	-	-	-	76	-	-	76
Cardiology	-	65	-	-	3	2	70
Total	45	265	73	163	3	6,022	6,573

All values in US$, TAM as of March 2025, as analysed by the Company

Complex injectables portfolio by technology

Technology	No. of products	As % of Total	TAM US$ mn	as % of TAM
Hormone	7	42%	363	6%
Peptide	4	19%	2,080	32%
Suspension	3	14%	262	4%
Microsphere	2	10%	716	11%
Nano Suspension	1	5%	2,890	43%
Complex API	1	5%	88	1%
Emulsion	1	5%	174	3%
	19	100%	6,573

All Values in US$, TAM as of March 2025, as analysed by the Company

Current TAM of complex injectables and estimated launches

							(TAM US$ mn)
Category	CY23A	CY24A	CY25E	CY26E	CY27E	CY28Eand beyond	Total
Nano Suspension	-	-	-	-	-	2,890	2,890
Peptide	14	-	-	-	-	2,066	2,080
Microsphere	-	-	-	-	-	716	716
Hormone	31	177	73	76	3	2	363
Suspension	-	-	-	87	-	175	262
Emulsion	-	-	-	-	-	174	174
Complex API	-	88	-	-	-	-	88
Total	45	265	73	163	3	6,022	6,573

All Values in US$, TAM as of March 2025, as analysed by the Company.

Small molecules pipeline as per AN DA - patent certification

AN DA - patent certification	No. of ANDAs	TAM US$ mn (March, 2025)
NCE-1	4	532
PI	31	960
Pll	6	105
Pill	3	107
PIV	27	3,544
TOTAL	71	5,248

All Values in US$, TAM as of March 2025, as analysed by the Company.

Pipeline products and Innovators Year off-patent

(TAM US$ mn)

Therapeutic area	Genericised			CY25		CY26		CY27	CY28and beyond			Total
	TAM	ANDAs	TAM	ANDAs	TAM	ANDAs	TAM	ANDAs	TAM	ANDAs	TAM	ANDAs
Ophthalmology	461	9	-	-	-	-	695	1	1,154	8	2,310	18
CNS Health	40	1	-	-	1,327	1	-	-	-	-	1,367	2
Cardiology	227	5	44	1	-	-	-	-	384	6	655	12
General Health	18	5	-	-	-	-	-	-	142	1	160	6
Mineral Supplements	95	2					-	-	49	1	145	3
Hematology	107	5	-	-	-	-	-	-	-	-	107	5
Oncology	48	2	33	1	-	-	-	-	26	2	107	5
Pain Management	89	3	-	-	-	-	5	1	-	-	94	4
AntiHnfectives	12	2	-	-	-	-	-	-	79	3	92	5
Chemo-adjuvants	20	1	-	-	-	-	-	-	54	1	74	2
Opioid Antagonists	-	-	-	-	-	-	-	-	51	2	51	2
Nephrology	8	1	-	-	-	-	-	-	27	1	35	2

TAM values are in US$ mn, and ANDAs are in number

Our strengths take us forward

We have established a strong and sustainable position in the global injectable market by staying true to our core strategic pillars. A relentless focus on quality and compliance, a carefully curated differentiated portfolio, disciplined cost management, sustained R&D investments, world- class manufacturing capabilities, and a well-structured B2B model have been the cornerstones of our growth. Together, these strengths enable us to navigate industry complexities, capitalise on emerging opportunities, and deliver consistent value to all stakeholders.

Quality and compliance

We view quality and compliance not merely as regulatory necessities but as integral elements of our philosophy. Our robust track record, marked by zero USFDA warning letters across all facilities since inception, reflects this unwavering commitment. Approximately 37% of our workforce is dedicated to quality control and assurance, demonstrating the scale of our investment in upholding global standards.

We reinforce our operations through over 40 audits annually, comprising internal checks and external inspections by regulatory authorities and partners. Our facilities are accredited by leading agencies including USFDA, MHRA (UK), ANVISA (Brazil), TGA (Australia), and BGV Flamburg (Germany), validating our ability to meet diverse compliance requirements. With advanced Quality Management Systems, high digitalisation focus including Laboratory Information Management Systems (LIMS), and quarterly internal audits, we adopt a proactive and preventive approach to quality assurance.

Differentiated portfolio

Our specialisation in the high-growth injectables segment enables us to leverage deep domain expertise and address evolving market needs effectively. The global injectables market, growing at a double-digit CAGR, presents a significant opportunity driven by the rising prevalence of chronic diseases, greater adoption of biologies, and the advantages of injectable delivery systems.

Our portfolio covers key therapeutic areas such as oncology, ophthalmology, blood-related treatments, neurology, and pain management. We emphasise the development of complex injectables, including New Chemical Entity- ls (NCE-ls), first-to-file generics, and 505(b)(2) filings. Additionally, we are expanding into emerging segments such as peptides, long-acting injectables, suspensions, and hormonal products, ensuring that our pipeline remains aligned with future demand drivers

Cost efficiency

Cost leadership remains a critical pillar of our competitive strategy, strengthening both our profitability and market agility. We consistently achieve superior gross margins compared to peers by focusing on operational efficiencies, backward integration, and efficient supply chain management

Our backward-integrated manufacturing capabilities provide greater control over API costs and supply stability, while continuous process improvements enhance our manufacturing productivity. Through optimised supply chain management, we minimise costs and ensure timely delivery, enabling us to offer high-quality products at competitive prices while reinvesting in strategic growth initiatives.

Research and Development

Research and development form the cornerstone of our growth strategy. We maintain consistent R&D investment levels and have built a dedicated team comprising scientists, including PhDs, pharmacy postgraduates, and chemistry specialists, to drive our innovation agenda.

Our R&D efforts focus on developing complex injectables, enhancing existing formulations, exploring novel drug delivery technologies, and collaborating with specialty pharma partners to co-develop targeted products. We place strong emphasis on product lifecycle management, ensuring continuous improvement and competitiveness across our portfolio.

Manufacturing excellence

Our world-class manufacturing capabilities serve as critical enablers of our global ambitions. We operate seven state- of-the-art manufacturing facilities including four finished formulation plants and three API plants designed to deliver scalability, flexibility, and efficiency.

With 32 production lines capable of producing multiple injectable formats such as vials, lyophilised vials, ampoules, pre-filled syringes, bags, and ophthalmics, we are well positioned to cater to diverse global markets. Our specialised facilities for oncology and biotech products, supported by in-house API production, enhance supply chain security, improve cost structures, and ensure quality at every stage of production.

Diversified B2B business model

Our focus on a diversified B2B model has given us a resilient and scalable growth engine. Through strategic partnerships with leading global pharmaceutical companies, we secure predictable cash flows via long-term supply contracts, achieve economies of scale, and maintain low working capital requirements

Our strong partner relationships, built on a foundation of quality and reliability, have translated into greater market share and recurring business. While B2B remains our core focus, we also selectively participate in Indias B2C market, leveraging our manufacturing strengths to enhance market presence without diluting our core strategy.

Cenexi: Transforming and integrating for a stronger tomorrow

In 2023, we completed the strategic acquisition of Cenexi, a leading European Contract Development and Manufacturing Organization (CDMO) with a strong footprint in sterile injectables and complex formulations Fleadquartered in France, Cenexi operates four specialised manufacturing sites across Fontenay, Herouville, Osny (France), and Braine-lAlleud (Belgium). These facilities, originally spun off from global pharmaceutical majors such as Roche, Merck, and NextPharma, bring a legacy of regulatory rigor, technological sophistication, and deep formulation expertise. All sites are approved by major global health authorities including US FDA, EMA, and ANVISA, reflecting a strong compliance foundation.

Our acquisition strategy prioritises global expansion, service portfolio enhancement, and strengthening our position as a leading CDMO. Cenexi facilitated immediate entry into the established European market and broadened our product portfolio with specialised capabilities in high- value segments like hormones and controlled substances.

To improve Cenexis financial performance, a focused turnaround strategy was initiated to stabilise operations, improve cost structures, and unlock the platforms full potential. Key initiatives underway included:

• Streamlined operations through identification of production bottlenecks and overall Equipment Effectiveness (OEE) tracking

• Strengthened technical transfers and process optimisation for improved throughputand consistency

• Renegotiated legacy contracts and enhanced pricing strategy to improve profitability

Performance in FY 2024-25

In FY25, Gland reported consolidated revenues of Rs. 56,165 million, broadly in line with the previous year. Consolidated EBITDA stood at Rs. 12,689 million, translating to a margin of 23%. Excluding Cenexis performance, the base business recorded revenues of Rs. 41,248 million and a stronger EBITDA margin of 35% (Rs. 14,451 million).

Within the base business, overall volume growth-driven by new launches-stood at 4%, led by a 9% increase in the US market. New product introductions in US market contributed 6% to the full-year revenue. R&D investments totaled Rs. 1,922 million, accounting for 4.7% of base business revenue. On the compliance front. Gland received Establishment Inspection Reports (EIRs) from the USFDA

• Enhanced business development and customer service functions to drive deeper engagement and responsiveness

In the near term, efforts are concentrated on restoring operational efficiencies, ramping up utilisation, and delivering margin improvements through a combination of cost optimisation, capacity unlocking, and improved mix Site-specific upgrades, such as investing in automation and enhancing quality infrastructure (e g, visual inspection machines), are expected to drive visible performance gains.

Looking to the medium term, Cenexi is poised to play a pivotal role in Glands global CDMO journey. A multi-year program has been planned to modernise manufacturing infrastructure, introduce new lines (particularly for prefilled syringes, vials, and cartridges), and expand capabilities in high-potency and lyophilised formulations. In parallel, cross-leveraging the combined Gland-Cenexi customer base is expected to unlock new business opportunities and enhance overall competitiveness

With a clear roadmap and aligned strategic priorities, Cenexi is well-positioned to contribute meaningfully to Gland Pharmas growth, profitability, and global reputation as a high-quality, integrated pharmaceutical solutions provider

for its Dundigal and Pashamylaram facilities, confirming successful completion of inspections.

Profit After Tax (PAT) for the full year was Rs. 6,985 million, with a margin of 12%. Other income rose to Rs. 2,136 million, largely driven by higher interest income. As on March 31, 2025, the company maintained a robust financial position, with cash and cash equivalents of Rs. 25,562 million and a net cash position of Rs. 22,870 million after accounting for Cenexis debt. Operating cash flow stood at Rs. 9,147 million, and the average cash conversion cycle improved marginally to 172 days. Capital expenditure for the year amounted to Rs. 3,938 million, directed towards expanding production lines and enhancing packaging capabilities across both Indian operations and Cenexi

Revenue from operations

By Customer Location:							(Rs. in mn)
	YoY	FY2024-25		FY2023-24		FY2022-23
	Change(%)	Revenue	Rev. (%)	Revenue	Rev. (%)	Revenue	Rev. (%)
USA	2%	27,403	49%	26,878	47%	20,910	58%
India	(19)%	4,765	8%	5,880	10%	5,548	15%
Europe	(3)%	10,225	18%	10,528	19%	1,871	5%
Canada	77%	1,574	3%	890	2%	795	2%
Australia	19%	743	1%	626	1%	218	1%
New Zealand	174%	77	0%	28	0%	11	0%
Rest of World (ROW)	(4)%	11,378	21%	11,817	21%	6,893	19%
Total	(1)%	56,165	100%	56,647	100%	36,246	100%

 

							(Rs. in mn)
	YoY	FY2024-25		FY2023-24		FY2022-23
	Change [%)	Revenue	Rev. (%)	Revenue	Rev. (%)	Revenue	Rev. (%)
USA	0%	30,387	54%	30,375	54%	23,956	66%
India	(11)%	2,487	4%	2,810	5%	2,501	7%
Europe	(2)%	10,470	19%	10,648	19%	1,870	5%
Canada	36%	1,203	2%	885	2%	796	2%
Australia	19%	743	2%	622	1%	218	1%
New Zealand	12%	75	0%	68	0%	11	0%
Rest of World (ROW)	(4)%	10,800	19%	11,239	20%	6,894	19%
Total	(1)%	56,165	100%	56,647	100%	36,246	100%

 

							(Rs. in mn)
	YoY	FY 2024-25		FY 2023-24		FY 2022-23
Business model	% Change	Revenue	Rev.(%)	Revenue	Rev.(%)	Revenue	Rev.(%)
B2B - IP led - Own ANDA	(5)%	18,446	33%	19,432	34%	11,957	33%
B2B - IP led - Partner ANDA	(1)%	13,896	25%	14,013	25%	17,059	47%
B2B - Tech Transfer	3%	22,768	41%	22,030	39%	5,999	17%
B2C - India	(16)%	794	1%	942	2%	904	2%
Export Incentives - India	14%	261	0%	230	0%	327	1%
Total	(1)%	56,165	100%	56,647	100%	36,246	100%

Key Financial Ratios

Particulars	YoY% Change	FY2024-25	FY2023-24	FY2022-23
Debtors turnover	(22%)	3 65	4.66	3.72
Inventory turnover	10%	2 64	2.41	1.53
Current ratio	7%	4.33	4.04	9.46
Interest coverage ratio	(9%)	82.59	90.71	163.00
Debt equity ratio	(25%)1	0.03	0.04	0.00
EBITDA margin (%)	(4%)	22.59	23.53	28.27
Net profit margin (%)	(9%)	12.44	13.64	21.55
Return on net worth (%)	(16%)	7.82	9.26	10.89
Return on Capital Employed (ROCE)(%)	(18%)	9.42	11.42	11.48

(1) Decrease in borrowings

Human resources

With over 4,300 professionals, the Company prioritises its people, recognising that empowered employees drive performance. Its people strategy focuses on attracting talent, enabling continuous learning, and developing future leaders.

This year, the Company intensified capability building, emphasising employee competency development across functions. Through upskilling and leadership programs, the Company equips its workforce to excel in a dynamic environment.

The Companys talent management is committed to diversity, equity, and inclusion. By fostering meritocracy and collaboration, the Company ensures individual opportunity for meaningful contribution and professional growth. Extensive training strengthens technical proficiency, interpersonal skills, cultural awareness, and behavioral development.

The Company has expanded its workforce and cultivated a vibrant, purpose-driven culture. Employees are encouraged to engage, share ideas, and innovate confidently. By building a diverse, engaged, and future-ready workforce, the Company creates an ecosystem where individuals thrive and contribute to organisational success

Risk management

At the heart of the Companys governance philosophy lies a forward-looking and integrated approach to risk management. Operating across multiple geographies and complex regulatory environments, the Company is exposed to a wide range of dynamic risks, economic volatility, geopolitical shifts, legal and compliance issues, environmental factors, operational disruptions, and foreign exchange fluctuations.

Recognising that effective risk management is not merely a defensive mechanism but a strategic enabler, the

Company has embedded risk awareness into its decisionmaking processes at all levels. The Risk Management Committee, empowered by the Board and supported by the Executive Management Team, steers a comprehensive and agile risk management framework. This framework is continuously reviewed and refined to remain aligned with the Companys long-term strategic priorities and the evolving external environment.

To further elevate its risk intelligence capabilities, the Company has engaged a global risk advisory partner. This collaboration brings the best international practices and deep sectoral insights to proactively identify emerging risks, benchmark risk tolerance thresholds, and enhance mitigation strategies across the enterprise.

Risks are systematically categorised across internal and external dimensions, with structured risk registers, early warning indicators, and scenario-planning tools deployed to anticipate and respond to potential disruptions. This structured approach fosters a culture of ownership, responsiveness, and resilience, with clear accountabilities across functional and leadership teams.

Moreover, the Companys risk governance is tightly integrated with its business continuity planning and sustainability agenda. This ensures that risk considerations extend beyond financial impacts to encompass ESG factors, reputational risk, and stakeholder trust.

By institutionalising a culture of intelligent risk-taking and rigorous oversight, the Company is not only safeguarding value but also enabling sustained growth and innovation in a rapidly evolving global landscape.

Risk management committee

Ms. Naina Lai Kidwai

(Chairperson & Independent Director)

Mr. Srinivas Sadu (Executive Chairman)

Dr. Jia Ai Zhang*

(Non-Executive Director)

Mr. Ravi Shekhar Mitra

(CFO)

*Dr Jia Ai Zhang has been appointed as a member of the Committee, effective November4, 2024, succeeding Mr. Yao Fang following his retirement

Future growth strategy

Gland Pharmas future growth strategy will be anchored on four key pillars: geographic expansion, portfolio diversification, strategic collaborations, and seamless global integration.

In the United States, our focus remains on developing complex, high-value pharmaceuticals. We are actively pursuing in-licensing opportunities and forging strategic partnerships to drive innovation. Our collaboration with Cenexi provides a strong platform to unlock growth potential across Europe, further enhancing our international reach.

Beyond the US and Europe, we are targeting select high- potential markets where US-approved products can be effectively leveraged to accelerate growth and expand market share.

To efficiently broaden our product base and market access, we are pursuing licensing opportunities for differentiated products and novel technologies. With a deep focus on complex pharmaceuticals, we aim to address unmet clinical needs and create clear market differentiation.

Collaboration continues to be a cornerstone of our approach. By partnering with leading companies, research institutions, and innovation hubs, we are working to streamline development timelines and bring advanced therapies to market more swiftly.

A major initiative in our pipeline is the establishment of a biosimilar-focused Contract Development and Manufacturing Organisation (CDMO), with capabilities extending well beyond biosimilars. This includes a strategic emphasis on biologies, complex fill-finish processes, and emerging dosage formats, positioning us to serve the growing demand for next-generation biopharmaceuticals and strengthen our footprint in the rapidly advancing biologies space.

Internal controls

The Company has implemented rigorous procedures for internal controls, overseen by the Board of Directors and the Executive Committee. A comprehensive internal control system has been established and continuously improved over the years through investments in enhancing the control framework and processes. This is in addition to the existing embedded controls, standards, and monitoring controls already in place.

Disclaimer

The Management Discussion and Analysis (MDA) section may contain statements anticipating prospects. These statements may involve known and unknown risks and uncertainties that could result in significant differences between the actual results and the forward-looking statements. The estimates presented in the report are based on certain assumptions made by the Company, considering internal and external information currently available. However, the underlying factors of these assumptions are subject to change over time, which may cause corresponding changes in the estimates. It is important to note that forward-looking statements reflect the Companys intentions, beliefs, or expectations as of the date they are made. The Company is not obligated to revise or update forward-looking statements based on new information, future events, or other factors.