The Next Shape of Growth
Across Markets. Across Modalities.
FY 2025-26 marked another year of strategic transformation for the Company, as Alkem continued to strengthen its position across core pharmaceutical businesses while accelerating investments into future growth platforms.
The Company recorded:
x Sustained growth in the India business, supported by strong performance in chronic therapies x A more stable performance in the United States, reflecting a calibrated approach to portfolio expansion x Continued growth in international markets, driven by branded generics During the year, Alkem also advanced multiple long-term growth engines including biosimilars, Bio-CDMO, MedTech and consumer healthcare — expanding its presence beyond traditional generics into differentiated and technology-driven healthcare segments.
These investments are aligned with the Companys long-term strategy of building a diversified, innovation-led healthcare platform with multiple scalable growth drivers.
Global Pharmaceutical/ Healthcare Industry
The global pharmaceutical industry grew by 9.3% in 2025 to an estimated US$ 1,939 Billion from US$ 1,764
Billion in 2024. The steady growth was driven by ageing population, rising incidences of chronic diseases, growing government investments, advancements in biologics, steady rise in demand for complex generics, spurt in personalised medicine, and digital health applications in pharmaceuticals. The market is estimated to grow at 5-8% CAGR to reach US$ 2,630-2,660 Billion by 2030, primarily led by the growing contribution of new products and the impact of patent expiries, including the growing impact of biosimilars and complex generics. Increasing regulatory pressures, including U.S. IRA pricing reforms and EU HTA frameworks, are reshaping pricing dynamics across the global pharmaceutical industry.
The healthcare industry covers a plethora of items related to peoples wellbeing and prosperity including drugs, clinical gadgets, indicative hardware, services, and healthcare benefits, each pointed toward forestalling, diagnosing, treating, and overseeing different ailments. The sector continues to witness strong growth driven by factors like ageing population, rising rates of chronic diseases, and extending healthcare access in rising economies. Apart from these, telemedicine, AI, digital medicine, cloud-based health information systems, precision medicine, wearable devices and customised medication, are reshaping the healthcare industry with fast paced innovation. Healthcare industry is becoming increasingly patient-centric and data-driven with rapidly growing awareness and access to care.
Strategic shifts in pharma manufacturing are increasingly focused on the adoption of continuous manufacturing and automation to enhance supply chain resilience and reduce operational overhead. Leading biopharma companies are aggressively investing in R&D to transition from traditional chemical synthesis toward complex large-molecule biologics.›
In 2025, the pharmaceutical the market reached ~US$ 1.7 Trillion, at list prices, up 10% driven by established medicines and a continued flow of innovation-led drugs. An estimated 73 novel active substances were launched globally in 2025, exceeding the average of the past decade.›There is a distinct spike in demand for high-margin speciality pharmaceutical products given rapid advancements in biologics, personalised medicine, and RNAi-based therapeutics for complex therapies. Due to their cost effectiveness with comparable efficacy, biosimilars are gaining significant traction. Expansion of telehealth services is facilitating greater access to healthcare.
In terms of region, the US continued to dominate with ~53% of the market share, followed by Europe at 24%, led by Germany and France. APACs share of sales was 11%, with China continuing as the worlds second largest pharmaceutical market. Middle East and Africa (ME&A) saw robust growth during the year, led by countries such as Saudi Arabia, reflecting improved access and policy reforms alongside rising demand. In Asia, while China continues to be the largest pharmaceutical market, MNCs are hesitating to invest in China, marked by regulatory tightening, geopolitical risks, and aggressive local competition. China+1 strategy has largely benefitted the Indian pharmaceutical market.
In 2025, ~43% of global pharmaceutical value was constituted by oncology, immunology, and diabetes. There has been a rapid ascent of obesity, which entered the top five therapy areas globally, emerging as the second largest contributor to growth.
The global biotechnology market was estimated at US$ 1.77 Trillion in 2025 and is likely to increase to US$ 2.02 Trillion in 2026 being transformed by"AI which aids in speed, precision and lowers the cost in areas like drug discovery, clinical research, data analysis, personalized treatment plans, early disease detection etc.
x Key high-growth areas include biopharmaceuticals, bioinformatics, and regenerative medicine. x North America accounted for the highest revenue share of 37.4% in 2025. x Developing countries like China, Japan, and India, are witnessing high growth supported by government efforts to simplify regulations, speed-up product approvals, improve reimbursement policies, and accelerate the approval process. x By application, the bio-pharmacy segment captured the biggest market share of 42% in 2025. x By technology, the tissue engineering and regeneration segment held the highest market share of 19.17% in 2025. The biotechnology market is expected to grow at 13.6% CAGR from 2026 to 2035 to US$ 6.34 Trillion by 2035, driven by increasing rates of chronic diseases, technological advances such as gene editing, AI-driven drug discovery, and rising demand for precision medicine. The biotechnology market benefits from rising government focus on healthcare spending, the demand for personalised medicine and sustainable bioprocesses.
Source: Precedence Research
Patient care is changing with wearables health devices, smarter diagnostic tools, and virtual platforms. There is a growing demand for tools and technology that enable more effective diagnosis, treatment and disease management. The global medtech is witnessing robust growth driven by the increasing demand for better medical solutions and innovations in healthcare technology. The global medtech market was valued at US$ 572 Billion in 2026 driven by increasing demand for digital health solutions, telemedicine adoption and increase in usage of wearable device. The North American MedTech market is a global leader, particularly in the United States led by advanced healthcare infrastructure, high investment in R&D, and a growing demand for innovative medical technologies. The market is estimated to grow to US$ 808 Billion by 2035 at 4.4% CAGR. New markets in Asia and the Middle East provide ample growth opportunities for expansion of healthcare technology in turn resulting in growing demand for better medical tools and equipment. There is a growing demand for digital health tools and robotic surgery systems supported by the rise in the number of ageing population and chronic diseases, and rising government healthcare expenditure.
Source: https://www.businessresearchinsights.com/market-reports/med-tech-medical-technology-market-117917
The pharmaceutical market is on the cusp of major digital transformation with AI-driven drug discovery, real-world evidence generation, and digital QA/QC systems. These digital technologies are leading to marked improvement in efficiency across R&D and commercialisation processes. Rapid advancements in biotechnology, precision medicine, and novel drug delivery platforms are reshaping treatment paradigms and strengthening the competitive landscape. There is increased focus on research to develop targeted therapies offering higher efficacy and improved safety profiles. Expansion of biologics, cell-based therapies, and monoclonal antibodies has diversified product portfolios and enhanced therapeutic specificity. Digital integration within clinical trials has improved patient recruitment, monitoring accuracy, and data analysis efficiency. Artificial intelligence-driven drug discovery tools are accelerating compound identification and reducing development timelines.
Strict regulatory guidelines govern drug approval, safety, marketing, and pricing under compliance check by various authorities such as the FDA, EMA, and CDSCO. These regulatory bodies ensure product quality and post-marketing surveillance, but lead to lengthy development timelines and increased operational cost burden. Changes in regulatory guidelines impact operations of players and may lead to delay while players comply with new/modified norms. Regulatory complexity favours established companies with experience, brand equity and resources to navigate compliance and forms a hinderance for new entrants.™
The increasing number of patients suffering from acute and chronic diseases, including diabetes, cancer, and others, coupled with growing awareness regarding treatment options, is resulting in a growing number of patients undergoing diagnostic and surgical procedures. The rise in inpatient admissions and the increasing number of surgical and diagnostic procedures, is leading to a surge in demand for products, including capital equipment and consumables, across developed and emerging countries. With cardiovascular diseases being the leading cause of death in the US, the devices market for cardiovascular treatment is witnessing strong traction. Heart or coronary artery stents are among the most essential cardiovascular devices.™
Overall, the™pharmaceutical industry outlook 2026™reflects a market transitioning toward integrated ecosystems that combine innovation, manufacturing excellence, and regulatory alignment. Large molecules are expected to contribute the majority of incremental revenue growth, supported by strong adoption of biologics and advanced therapies. Pricing reforms, biosimilar competition and supply chain disruptions due to ongoing geopolitical conflicts remain key considerations.
IQVIA Early Bird: 2025 Revealed - The Trends Shaping Pharmas Future IQVIA
Global Medicine Use Trends 2026 IQVIA
Market Overview
3.1 India
The Indian pharmaceutical market has had strong growth of 9.0% in FY 2025-26.
Indias pharmaceutical industry (IPM) is often referred to as ‘Pharmacy of the World being the largest provider of generic medicines globally. India holds nearly 20% of global supply share in terms of volume with exports to 190+ countries. The IPM ranks third in production by volume and 14th by value. India is the worlds leading vaccine exporter, supplying 65-70% of the World Health Organizations (WHO) vaccine requirements, particularly for DPT, BCG, and measles. IPM plays a significant role in affordable HIV treatment. Led by the China +1 strategy among large pharmaceutical markets, India is solidifying its position as a key global pharmaceutical supplier. Indias API industry ranks third largest in the world, with 57% of APIs on the WHO.
Indian Pharma Market (IPM) - Key Therapy Areas (FY 2025–26)
| Therapy Area | Sales (3 Cr) | Contribution (in %) | Y-o-Y Growth FY 2025–26 (in%) |
| Cardiac | 30,287 | 14.1 | 13.8 |
| Gastrointestinal | 23,397 | 10.9 | 5.7 |
| Anti-infectives | 21,466 | 10.0 | 4.0 |
| Anti-diabetic | 20,884 | 9.7 | 11.5 |
| Vitamins/Minerals/Nutrients | 17,300 | 8.1 | 9.2 |
| Respiratory | 18,287 | 8.5 | 11.3 |
| Pain/Analgesics | 16,786 | 7.8 | 7.2 |
| Neuro/CNS | 13,418 | 6.3 | 9.8 |
| Dermatology | 15,005 | 7.0 | 6.1 |
| Gynecology | 9,617 | 4.5 | 7.8 |
Source: IQVIA SSA Data March 2026
India boasts of having the highest number of US-FDA compliant pharmaceutical plants outside of USA. The IPM includes approximately 3,000+ drug companies and 10,500+ manufacturing units offering over 60,000 generic brands across 60 therapeutic categories. The IPM is currently valued at USD 60 Billion is expected to reach USD 130 Billion by 2030, as per the Indian Ministry of Commerce. The primary growth drivers include rising incidence of chronic diseases, ageing population, growing life expectancy, increased health awareness, expanded access to healthcare services, and a stable regulatory environment encouraging innovation.
India ranks 11th (in terms of value) in global pharmaceutical exports, with 3% share. More than half of the Indian pharmaceutical exports are directed to highly regulated markets such as the United States (34% of total Indian pharmaceutical exports) and Europe (19% of total Indian pharmaceutical exports). The export of medical devices has grown from USD 2.5 Billion in FY 2020-21 to USD 4.1 Billion in FY 2024-25. The industry is constantly striving to shift from a volume-driven to a value-driven model, by increasing focus and R&D investment in complex generics, biosimilars, and integrated therapies. Focus is also high on reducing import dependency through the adoption of advanced manufacturing technologies such as AI and 3D Printing, along with streamlining global certification processes to strengthen international market access.
The IPM is a crucial focus point of the government. With the vision of transforming India into a leading global biopharma industry and capturing 5% of the global biopharmaceutical market share, the government laid strong focus on biopharma and biologic medicines in healthcare and manufacturing strategy in the Union Budget 2026-27. Several other policies were also announced to promote the pharmaceutical sector including PLI scheme for Bulk
Drugs, Revamped Pharmaceuticals Technology Upgradation Scheme, scheme for Promotion of Bulk Drug Parks, PLI for Medical Devices etc. Biopharma SHAKTI, was launched with an outlay of ™ 10,000 Crore over the next five years, with an aim to develop India as a global manufacturing pharma hub. This is to strengthen end-to-end ecosystem for biologics and biosimilars, support domestic development and manufacturing of high-value biopharmaceutical products and medicines, reduce import dependence, and enhance Indias competitiveness in global biologics supply chains.
While the IPM has been dominating the formulations market globally, there is increased structural focus to move up the value chain with backward integration in Active Pharmaceutical Ingredients and Key Starting Materials and strong focus on differentiated and complex-value offerings like complex generics, speciality APIs and advanced therapeutic forms. India is slowly emerging as a resilient and integrated pharmaceutical manufacturing hub led by a substantial capital expenditure cycle, policy support through Production Linked Incentive schemes, and robust supply chains.
Source: Investing in Indias Pharmaceutical Industry: Key Growth Prospects
Alkem with continued focus on strengthening presence in chronic therapies like oncology, enhancing doctor engagement, expanding reach across markets, building a widespread distribution network and establishing a strong presence in future growth categories like medical devices, trade generics and complex therapies is well-positioned to ride the growth opportunity in the IPM. With a diversified manufacturing base, strong regulatory track record and expanding differentiated product portfolio, the Company is well-positioned to benefit from the global diversification of pharmaceutical supply chains.
3.2 United States
The growth in the US pharmaceutical market is driven by growing prevalence of chronic diseases, rising healthcare expenditure, advancements in therapeutics, increasing geriatric population and growth in personalised medicine. Net medicine spending in the US market increased by USD 58 Billion (10.6%) in aggregate, rising from USD 548 Billion in 2024 to USD 606 Billion in 2025, with most growth driven by protected brands outside GIP/GLP-1 agonists and COVID-19 vaccines and therapeutics. GIP/GLP-1 agonists across diabetes and obesity contributed USD 14 Billion in growth, with USD 9.6 Billion concentrated in products approved for obesity and related comorbidities. Market growth is attributable to technological advancements, led by AI advancements and machine learning, which are expected to provide significant boost to R&D and drug discovery.
Total net spending on medicines in 2030 is expected to increase by USD 200 Billion compared to 2025, as volume growth and adoption of innovation are partly offset by lowerprice drivers such as patent expiries and policy effects. Growth will be driven by the adoption of newly launched innovative products, with an average of 50–55 new medicines expected to launch annually over the next five years, including therapies in oncology, immunology, and other speciality areas, as well as more traditional treatments in diabetes, obesity, and neurology. The US generic drug market remained resilient, and poised to embark significant patent expiry cycles between 2025 and 2035, with nearly 200 blockbuster drugs to lose patent protection, unlocking meaningful opportunities for generic and biosimilar players.
Source: U.S. Medicine Use Trends 2026 IQVIA
The Company continued to adopt a calibrated strategy in the US market with increasing focus on differentiated and complex product opportunities aimed at improving profitability and reducing exposure to commoditized segments.
Strategic priorities include injectables, oral oncology products, speciality opportunities and biosimilars, supported by selective portfolio expansion via organic & inorganic pathways and investments in manufacturing and development capabilities.
3.3 International Markets
Almost 14 larger growth high GDP countries (excluding the U.S.) are projected to grow by USD 155.1 Billion through 2030, with 83% of the growth from the top eight of these countries. The drivers of spending growth in developed markets are predominately the adoption of novel drugs, with most global launches reaching these markets within a year. Spending in Pharmerging countries is expected to grow by USD 120.8 Billion through 2030, with the top eight of these countries also driving 83% of growth.
Most therapy areas are expected to grow more slowly in the next five years. The biggest contributors to the growth in the next five years are oncology, immunology, diabetes, and obesity drugs. The growth is a result of a continuous influx of innovative products and in some cases offset by exclusivity losses. Lipid regulators are expected to witness growth both from volume-driven growth of older generics and newer therapies.
The Gulf States, particularly Saudi Arabia and the United Arab Emirates (UAE), are emerging as growth markets, supported by national health transformation programmes and an expanding willingness to invest in access to innovative therapies. In China, volume growth is moderating due to governments stringent pricing policy.
The policy landscape in the international pharmaceutical market is becoming increasingly complex, as the industry navigates Inflation Reduction Act (IRA) implementation, Most Favoured Nation pricing frameworks, executive programmes affecting drug pricing, and pharmacy benefit manager (PBM) reform.†
The Companys International business continued to grow steadily, supported by robust demand for branded generics and expansion in select geographies. The focus remains on scaling presence in key markets and strengthening distribution. The Company also continued to optimize its product portfolio and geographic mix, leveraging selected US products across other regulated and semi-regulated international markets to improve portfolio monetization and reduce concentration risk.
3.4 Biotech (Biologics and Biosimilars)
Biologics, having completely revolutionized diagnosis, treatment, and prevention of autoimmune conditions, cancers, and other diseases, are increasingly gaining traction owing to huge potential to offer reduced side-effects and targeted therapies. Biosimilars, which are cost-effective alternatives for high cost of biologics, offer and improved treatment option and expand access, due to lower cost. With sharp rise in burden of various chronic and life-threatening diseases, the demand, for both biologics and biosimilars, is witnessing substantial growth. The global biologics and biosimilars market is estimated at USD 244.7 Billion in 2026. The market is projected to reach USD 389.5 Billion by 2035, at 5.3% CAGR.
(Source: https://www.businessresearchinsights.com/market-reports/biologics-and-biosimilars-market-100693)
Biosimilars or generics pose significant threat to certain drugs. In 2027, a number of backbone therapies will face generic and biosimilar competition. Small molecules, palbociclib in breast cancer, enzalutamide in prostate cancer, and olaparib in a range of solid tumours, will all lose exclusivity in 2027. The PD-1 inhibitors pembrolizumab and nivolumab, are expected to face biosimilar competition starting 2028, with majority of impact on growth in 2029. This lower growth as the result of losses of exclusivity will be offset by continued uptake of novel modalities, including ADCs, bispecific antibodies, and cell and gene therapies.
Enzene represents the Companys strategic biologics platform, combining biosimilars, Bio-CDMO and advanced continuous manufacturing capabilities. The business is positioned to participate in the growing global demand for cost-efficient biologics development and manufacturing solutions while also building a differentiated biosimilars portfolio across regulated and emerging markets.
3.5 MedTech:
The MedTech sector is witnessing steady growth, supported by rising demand for diagnostics and medical devices, increased focus on preventive healthcare and expanding healthcare infrastructure. The sector is also benefiting from technological advancements and greater integration of digital solutions.
The global MedTech industry continues to expand on the back of demographic aging, rising chronic disease burden, technology-led innovation in implants, devices and digital health, and a structural shift toward elective and minimally invasive procedures. The global medical devices market is currently estimated at approximately USD 680 Billion, with orthopedic and cardiovascular together representing a meaningful share of the overall opportunity.
Indias MedTech market, valued at approximately USD 16 Billion, remains amongst the fastest-growing market globally. Growth is being supported by
x Expansion of insurance coverage: The government initiative PM-JAY covers all senior citizens aged 70+ regardless of income, alongside continued growth in private insurance penetration; x Production-Linked Incentive (PLI) schemes for medical devices and the National Medical Devices Policy 2023 strengthening domestic manufacturing; x Rising per capita healthcare spend and a younger urban population driving early adoption of elective procedures. MedTech in India has significant headroom for growth being an underpenetrated market with per capita consumption at USD 7 when compared to USD 50 for China, and USD 40 for Brazil. Substantial technology advances are leading to proliferation of in-use cases across disease areas. With low competitive intensity, the market presents significant growth opportunity to players with technological know-how. India holds the potential to become a giant global supplier with cost effective localized manufacturing.
The Orthopedic implants market in India is currently estimated at approximately ? 4,000 Crore within a global opportunity of ? 4,40,000 Crore. The Indian Cardiovascular devices market is approximately ? 7,000 Crore within a global opportunity of ? 8,10,300 Crore. Interventional cardiology and structural heart segments are among the most dynamic sub-segments globally.
Alkem MedTech represents a strategic adjacency with the potential to create a differentiated, high-entry-barrier healthcare platform spanning musculoskeletal and cardiovascular segments. The proposed Occlutech acquisition significantly accelerates this ambition by providing access to global regulatory approvals, clinical credibility, advanced structural heart technologies and established international distribution infrastructure.
Source: Internal estimate.
4. Business Performance
Sales by Key Markets (FY 2025–26)
| Business Segment | Sales (Rs Million) | Contribution to Total Sales (%) | Y-o-Y Growth (%) |
| Domestic Business | 398,514 | 67.8% | 9.7% |
| US Business | 329,845 | 20.5% | 20.3% |
| Other International Markets | 316.964 | 11.7% | 26.7% |
India Business
The India business remained the largest contributor to revenues. The Indian pharmaceutical market (IPM) registered strong growth of 9% in FY 2025-26. The Company grew marginally faster at 9.2% in the same period, with domestic sales of 3 8,832 Crore (IQVIA SSA MAT March 2026).
Key Highlights: x 3 98,514 Million Crore sales from domestic business x 9.7% Y-o-Y growth x 17 brands in the IPM Top 300 x #1 in anti-infectives in India for 15+ consecutive years x #2 in Vitamins/Minerals/Nutrients (VMN) x #3 in Pain and Analgesics x #4 in Gastrointestinal therapies x #3 most-prescribed company in the IPM (SMSRC MAT Feb26) In India, Alkem has established strong foothold in several acute therapy areas. The Company is among IPMs top six players, with an overall market share of 4.1%. It continues to demonstrate leadership and outperform in its top four therapy areas. The Company continues to outperform the market in its key focus therapies such as anti-diabetic, respiratory, dermatology, urology, and ophthalmology.
Power Brands Driving Growth x 17 brands crossed 3 100 Crore in annual sales x These brands contributed 52% of total domestic revenue x Collectively, they grew at 7.8% Y-o-Y, outpacing the IPM average Building market-leading brands remains central to the Companys India strategy. During FY 2025-26, several mega brands have seen robust performance with 35 brands featured among the top three ranks in their covered markets. Alkem is a leading player in the trade generics segment. The Companys three largest brands now feature among the top 12 in the IPM.
Notable brand performances include: x PAN: Remained in the top five brands in the IPM, growing 14.6% Y-o-Y x PAN-D: Ranked 12th x Clavam: Rose two ranks to rank 9, growing 12.3% Beyond legacy brands, new launches remain a critical driver of the Companys growth. Alkem is ranked among the top four companies in terms of sales contribution from new introductions. The Company has effectively capitalized on recent loss of exclusivity (LoE) opportunities in the anti-diabetic segment, including Empagliflozin—where it ranks among the top four post LoE generics with revenues exceeding 3 25 Crore. Additionally, the Company launched Semaglutide injectables on Day-1 across both indications including diabetes and obesity management.
The Company further continues to focus on chronic therapies—including anti-diabetes, dermatology, urology and inhaled chronic respiratory, where it is outpacing market growth and gaining market share. This year, the Company continued to build on past momentum by adding manpower for better geo-penetration and launching differentiated products in our portfolios.
The overall strength of the brands is underpinned by the prescriber confidence in safety, efficacy and quality. Performance was supported by a sustained focus on execution excellence, a field force of over 14,000+ marketing representatives and science-led engagement that deepens relationships with healthcare professionals.
Supported by continued investments in R&D, operational excellence, disciplined supply-chain management and an experienced leadership team, the Company is well placed to deepen its domestic franchise and pursue the next phase of growth in Indias pharmaceutical market.
Alkem commands leadership position (#5 in value terms) in the Indian Pharmaceutical Market (IPM). This growth has been driven by strong growth in chronic therapies, continued traction in key brands and improvement in field force productivity. The Company remains committed to further strengthen its position in high-growth therapy areas, leveraging its strong brand equity and physician trust.
Performance of New Product Launches
| BRAND | MOLECULE | LAUNCH | MAT VALUE MARCH 2026 |
| PAN RFT | ALGINIC ACID SODIUM | 202410 | 15.4 |
| CLAVAM | AMOXICILLIN+CLAVULANIC ACID (New Brand Ext) | 202407 | 11.7 |
| ALSITA-E / EMPANORM DUO | EMPAGLIFLOZIN+SITAGLIPTIN | 202503 | 10.1 |
| VONZAI | VONOPRAZAN | 202410 | 9.3 |
| PENTANERV GRDS | GABAPENTIN | 202411 | 8.7 |
| A TO Z CV | COQ10+UBIQUINOL+IDEBENONE | 202504 | 8.2 |
| KOJIGLO SERUM | DEMELANIZING AGENTS | 202502 | 7.6 |
| EMPANORM L | EMPAGLIFLOZIN+LINAGLIPTIN | 202503 | 7.0 |
| PULMOSMART G | BUDES. + FORMOT.+ GLYCOP | 202410 | 6.5 |
| XONE ES | CEFTRIAXONE+SULBACTAM+DISODIUM EDETATE | 202501 | 5.1 |
| FAMELIAL-F / FAMELIAL-M | SUPPLEMENTS FOR MALE & FEMALE HEALTH | 202411 | 4.7 |
| EMPANORM | EMPAGLIFLOZIN | 202503 | 4.2 |
| TAXIM-OFZ | OFLOXACIN+ORNIDAZOL.SOL | 202506 | 4.2 |
| NERVMAX-XT | PALMITOYLETHANOLAMIDE COMB. | 202411 | 4.0 |
| ENDOGOLIX | ELAGOLIX | 202501 | 2.9 |
Source: IQVIA SSA Data March 2026
Alkems performance in key therapeutic segments
| Therapy Area | Company Rank | Contribution (%)• | Market share (%) | Company growth (% Y-o-Y) | Industry growth (% Y-o-Y) |
| Anti-Infectives | 1 | 32 | 13.2 | 4.4 | 4.0 |
| Gastro Intestinal | 4 | 21 | 7.9 | 8.3 | 5.7 |
| Pain / Analgesics | 3 | 10 | 5.4 | 11.6 | 7.2 |
| Vitamins/Minerals/Nutrients | 2 | 13 | 6.7 | 18.4 | 9.2 |
| Anti Diabetic | 15 | 5 | 2.2 | 14.2 | 11.5 |
| Neuro / CNS | 8 | 4 | 2.4 | 8.6 | 9.8 |
| Gynaecology | 8 | 4 | 3.6 | 5.7 | 7.8 |
| Respiratory | 15 | 3 | 1.6 | 16.2 | 11.3 |
| Derma | 18 | 3 | 1.5 | 11.2 | 6.1 |
| Cardiac | 28 | 2 | 0.7 | 10.3 | 13.8 |
| Source: IQVIA SSA Data March 2026 |
Performance of Alkems Top 10 Brands
| Brand Molecule | Rank in molecule category | Brand sales ‡ Crore in FY 2025-26 | Market share (in %) |
| PAN Pantaprazole | 1 | 733.3 | 41.7 |
| PAN-D Domperidone+Pantoprazole | 1 | 599.7 | 35.5 |
| CLAVAM Amoxicillin+Clavulanic Acid | 2 | 649.2 | 17.1 |
| TAXIM-O Cefixime | 1 (+1) | 316.7 | 26.0 |
| A TO Z NS Ascorbic | 1 (+1) | 353.9 | 16.9 |
| Acid+Copper+Manganese+Nicotinamide+Pantothenic Acid+Pyridoxine+Retinol+Riboflavin+Vitamin E+Zinc XONE Ceftriaxone | 2 | 224.6 | 15.5 |
| UPRISE-D3 Colecalciferol | 1 | 274.4 | 24.1 |
| PIPZO Piperacillin+Tazobactam | 1 | 218.58 | 30.5 |
| TAXIM Cefotaxime | 1 | 155.4 | 83.8 |
| GEMCAL Calcitriol+Calcium & Combination | 1 | 171.9 | 19.6 |
Source: IQVIA SSA Data March 2026
United States Business
During the year, the US business, a strategic growth pillar, exhibited improved stability. In FY 2025–26, the Company generated ‰ 29,845 Million (Includes revenue from Enzene CDMO business) in sales from the US market, up 20.3% Y-o-Y. The strong growth was mainly on account of continued growth traction in new launches and volume increase.
Key Highlights: x ‰ 29,845 Million sales from the US business x 20.5% share of total Company revenue x 20.3% Y-o-Y growth x 194 cumulative ANDAs filed (192 ANDAs + 2 NDAs approved) x 167 cumulative ANDAs approved, including tentative approvals, of these; x 148 final ANDAs approvals x 19 tentative approvals x 01 BLA filed During the year, the Company launched Sacubitril/Valsartan. The Company revamped US portfolio targeting complex generics in injectables and oncology segments to tackle intense competitive pressure. In addition, the Company is looking to leverage existing US portfolio to other geographies like ROW, LATAM & Canada markets. The Company remains committed to expanding markets access to Middle east via JVs & Partnerships. During the year, the Company signed a deal with a partner for GLP-1 project for the global markets.
The Company aims to strengthen its US, AU, and Chile portfolio via in-licensing & leveraging its US portfolio. Also, it is exploring newer geographies via out-licensing model. The Company is expanding in-house capabilities via strategic capital investment.
As of 31 March, 2026 total of 192 Abbreviated New Drug Applications (ANDAs), 2 New Drug Applications (NDAs) and 01 BLA has been filed with USFDA; alongside 11 ANDSs filed with Health Canada.
As of 31 March, 2026 167 ANDAs; 02 NDAs were approved for USFDA and 05 ANDSs were approved for Health Canada.
The robust nature of the business is reflected in steady growth amidst continued geopolitical situation causing tremendous pressure on supply chain and product supply. To ease this pressure, the Company undertook proactive agile management of vendors, and CMO partners to remove any obstacles upfront before they become bottlenecks for commercial supply. The year also witnessed pricing pressure on generics, tariffs, complex geopolitical situation disrupting supply chain and MFN (Most Favoured National) pricing structure impacting business margins. The retail business for generics continued downward spiral due to increased competition and uncertain supply logistics.
During the year, US FDA streamlined regulatory & clinical pathway for biosimilars development, which will significantly alter the strategy by eliminating phase 3 requirement subject to satisfactory analytical characterization studied thereby reducing overall cost & development timelines for biosimilars. This presents a Multi-Billion-Dollar opportunity for biosimilar players in the coming decade eventually turning into Golden decade of biosimilars.
Alkems US ANDAs Filings and Approvals
| Year | Total filed (cumulative) * | Total approved (cumulative)*# |
| 2013-14 | 49 | 15 |
| 2014-15 | 63 | 19 |
| 2015-16 | 77 | 31 |
| 2016-17 | 91 | 39 |
| 2017-18 | 108 | 50 |
| 2018-19 | 127 | 70 |
| 2019-20 | 144 | 89 |
| 2020-21 | 152 | 110 |
| 2021-22 | 163 | 123 |
| 2022-23 | 175 | 134 |
| 2023-24 | 178 | 147 |
| 2024-25 | 185 | 156 |
| 2025-26 | 194 | 169# |
*includes NDA
#includes tentative approvals
The US market is gradually shifting to innovation / speciality products. Keeping pace with the evolving trends, the Company is scouting for opportunities that aligns with Alkems strategic priorities for US market. Future strategic priorities include focus on innovative products like complex generics including oral oncology and injectable products. Additional focus areas include biosimilars.
Update on US FDA Inspections
| Facility | Capability | Inspection Date | Regulatory Status |
| Baddi (India) | Formulations | Mar-24 | EIR Received in June 2024 |
| Daman (India) | Formulations | Apr-26 | Response submitted – EIR awaited |
| Taloja R&D (India) | Bioequivalence Centre | Apr-26 | EIR Awaited - No observation received. |
| Ankleshwar (India) | API | Apr-23 | EIR Received in July 2023 |
| Mandva (India) | API | Dec-23 | EIR Received in Mar 2024 |
| California (USA) | API | Sep-25 | EIR Awaited - No observation received. |
In FY FY2025-26, the Company underwent USFDA inspections at its Daman and Taloja R&D manufacturing facilities.
Other International Business
The Company international footprint spans across 40 international markets, apart from India and the US. Its key markets include LatAm, Australia, Europe (UK, Germany) and RoW markets (Philippines, Kazakhstan, South Africa, East Africa, etc.). The International business delivered consistent growth, driven by branded generics and strategic geographic expansion. This segment continues to offer long-term growth potential.
Alkems International Markets ANDAs Filings and Approvals
| Markets | FY 2025 | FY 2026 | ||
| Filed | Approved | Filed | Approved | |
| Australia | 83 | 77 | 82 | 79 |
| Europe | 54 | 37 | 51 | 37 |
| UK | 44 | 34 | 48 | 41 |
| New Zealand | 12 | 6 | ||
| Chile* | 227 | 224 | 235 | 222 |
| China | 10 | 2 | 7 | 5 |
| South Africa | 196 | 144 | 206 | 165 |
| Kazakhstan | 33 | 33 | 101 | 46 |
| Philippines | 28 | 28 | 137 | 97 |
| Brazil | 2 | 2 | 2 | 2 |
| Mexico | 48 | 16 | 51 | 17 |
| *2 products are discontinued |
Key highlights: x Sales grew by 26.7% Y-o-Y to ? 16,964 Million x Sales contribution stood at 11.7% to total sales
The emerging markets continued to be a key contributor to the Companys international portfolio in FY 2025–26, spanning Africa, CIS, Southeast Asia, the Middle East, and select other emerging markets. These regions offer long term growth opportunities in branded generics, supported by favourable demographics, improving healthcare infrastructure, and sustained demand for affordable, quality medicines. Emerging markets continued to operate in a dynamic environment influenced by currency volatility, pricing controls, tender driven demand, and varying regulatory timelines. Demand for branded generics remained resilient across most markets particularly in acute, hospital and high-volume segments while regulatory expectations continued to intensify across several geographies.
Regulatory & Portfolio Pipeline
Strengthening the regulatory and portfolio foundation remained a strategic priority during the year. Approximately
200+ dossiers were filed in FY 2025–26, enabling near term launches across priority emerging markets. To support sustained multi-year growth, around 1,675 in-house product dossiers have been shortlisted for filing during FY 2025-26 to FY 2027-28, providing strong visibility for future portfolio expansion.
In parallel, the Company plans to expand operations across ~29 new countries, including selective entry into B2C (direct to consumer) branded generics businesses in identified markets. This initiative is aimed at enhancing market reach, brand visibility, and margin profile. Presence will also be strengthened in 12 existing markets through increased portfolio depth and improved execution capabilities.
Challenges and Mitigation
Key challenges that emerged included regulatory approval delays in select markets, pricing pressure, currency fluctuations, and heightened competitive intensity in parts of South-east Asia. These were addressed through portfolio prioritization, calibrated pricing actions, disciplined working capital management, improved regulatory planning, and closer engagement with local partners and regulatory authorities.
Strategic Priorities and Outlook
Going forward, the strategy remains focused on profitable and sustainable growth. Key priorities include: x Replicating successful execution models from CIS and the Middle East across scalable markets x Strengthening growth momentum in Africa x Restoring performance in Southeast Asia through improved regulatory sequencing and focused launches x Expanding selectively into B2C businesses across new geographies x Continuing investments in regulatory, quality, and operational capabilities With a diversified geographic footprint, a robust regulatory pipeline, expanding B2C opportunities, and strong local partnerships, the Company is well positioned to build a resilient and scalable Emerging Markets platform over the medium term.
The Company continues to invest in areas that are at a relatively early stage but are expected to contribute to growth over the medium to long term.
Enzene Biosciences
Enzene Biosciences Limited, a subsidiary of Alkem, operates across the complete biologics value chain, research, development, and Good Manufacturing Practice (GMP) manufacturing. Its integrated ‘clone-to-vial capability covers cell line development, upstream and downstream processing, advanced analytical and bioanalytical characterization, and drug product development.
Enzene operates two business platforms in parallel: (i) a commercial biosimilars business serving the Indian market, with select pipeline assets out-licensed to global partners; and (ii) a CDMO business, serving domestic and international clients through its India facilities and its US subsidiary Enzene Inc. FY 2025-26 marked the year in which both platforms moved decisively from investment into execution, with the commissioning of US commercial operations, the launch of Pertuzumab in India, and the receipt of the first European regulatory approval for Denosumab.
Key Milestones
FY 2025-26 was a year of significant operational, regulatory, and commercial achievement across both Enzenes biosimilars and CDMO businesses:
x US biomanufacturing facility commissioned: Enzene Inc.s 80,000 sq ft facility in Hopewell, New Jersey — representing a $50 Million investment — was officially inaugurated in September 2025, establishing Enzenes first commercial manufacturing presence in the United
States and significantly strengthening the companys ability to serve North American clients.
EnzeneX™ 2.0 deployed at US facility: the next-generation EnzeneX™ 2.0 platform — the worlds first fully-connected continuous manufacturing (FCCM™) technology validated for commercial biologics supply — was deployed at the Hopewell site. The platform achieves up to 10 times the yield of conventional biomanufacturing methods, at a significantly lower cost of goods and carbon footprint.
Industry recognition for manufacturing innovation: Enzenes EnzeneX™ 2.0 platform was awarded the CPHI Pharma Award for Manufacturing Excellence (October 2025), recognised by an independent panel of pharmaceutical industry experts as the most advanced biologics manufacturing technology, acknowledging its role in advancing bioprocessing and driving down the cost of biologic medicines.
Pertuzumab commercially launched in India: Enzenes biosimilar for HER2-positive metastatic breast cancer was brought to market in India, expanding the oncology biosimilar portfolio to eight commercialised products and broadening patient access to HER2-targeted therapy.
Denosumab receives EMA Marketing Authorisation: Enzene received regulatory approval from the European Medicines Agency (EMA) for its Denosumab biosimilar
a treatment for osteoporosis and bone health indications. This marks Enzenes first approval in a major regulated international market, enabling commercial supply to European patients and validating the quality and regulatory capability of the Chakan (Pune) manufacturing facility.
Out-licensing agreements expanded: Enzene executed development and manufacturing out-licensing arrangements for select biosimilar pipeline assets in international markets, with the company responsible for development and supply while partners manage in-country registration and commercialisation. This model generates milestone and royalty revenue streams without requiring direct commercial investment in each geography.
CDMO pipeline continued to grow: Enzene expanded its portfolio of CDMO contracts across both the India and US facilities, with clients spanning a range of therapeutic areas and geographies. The Hopewell facility began reserving capacity for North American clients under both continuous and fed-batch manufacturing arrangements. x Enzene stands out through a combination of strong technical capabilities and a rapidly growing global clientele spanning human and animal health, with pharma partnerships across the US, Europe, and India, also positioning the company to address rising global demand for advanced animal health solutions.
As of 31 March, 2026, Enzenes total R&D headcount stood at 196.
Manufacturing capabilities
Enzene operates a dual-continent, integrated biomanufacturing network designed to serve global clients across clinical and commercial biologics needs. Both facilities are built to international GMP standards and are subject to regular audits by global clients and regulatory bodies.
| Parameter | India — Chakan, Pune | USA — Hopewell, New Jersey (Enzene Inc.) |
| Operating Entity | Enzene Biosciences Limited | Enzene Inc. |
| Facility Type | Commercial-scale biologics manufacturing; R&D hub | Clinical and commercial biologics CDMO; EnzeneX™ 2.0 continuous manufacturing flagship |
| Facility Size | Multi-unit bioreactor suite (20L–2,000L); fill-finish line | 80,000 sq ft; drug substance manufacturing suites, laboratories, storage, dispensing, and warehousing |
| Technology Platform | EnzeneX™ continuous manufacturing + traditional fed-batch | EnzeneX™ 2.0 (FCCM™) + fed-batch; |
| Key Capabilities | mAb manufacturing; upstream and downstream processing; advanced analytics and bioanalytical characterisation; fill-finish | Locally compliant US biologics manufacturing; North American CDMO; continuous and fed-batch drug substance production |
| Regulatory Certifications | EU GMP certified (both Pune facilities); EMA-approved supply of Denosumab to Europe; audited by multiple global clients and regulatory bodies | GMP operational; facility inaugurated September 2025; |
| FY 2025-26 Key Development | Pertuzumab commercially launched; Denosumab EMA approval received; CDMO contract base expanded; European supply initiated | 80,000 sq ft facility inaugurated; EnzeneX™ 2.0 deployed; CDMO capacity reservation commenced |
Product portfolio
Enzene has built a robust commercial presence in the Indian biosimilars market, with eight products now available across oncology, immunology, and chronic disease management.
The addition of Pertuzumab during FY 2025-26 brought the total commercialized portfolio to eight products, all developed, manufactured, and launched within a period of approximately four years.
| Product / Category | Therapy Area | Market | Status |
| Seven biosimilars (previously commercialised) | Oncology, immunology, and chronic care | India | Commercially available |
| Pertuzumab biosimilar | Oncology — HER2-positive metastatic breast cancer | India | Commercially launched — FY 2025-26 |
| Denosumab biosimilar | Bone health / osteoporosis | Europe (Global) | EMA Marketing Authorisation received; European commercial supply initiated |
| Select pipeline biosimilars (out-licensed) | Bone health and other indications | International markets | Development and manufacturing by Enzene; registration and commercialisation by regional partners |
| Early-stage pipeline candidates | Oncology and immunology | India and global | Under development; evaluation of near- term patent expiry opportunities ongoing |
Enzene has made substantial progress in building its international biosimilars business through regulatory submissions and a structured out-licensing model. The EMA Marketing Authorisation received for Denosumab during FY 2025-26 is a landmark milestone — Enzenes first approval in a major regulated international market — and validates the companys end-to-end regulatory capability from development through to GMP manufacturing.
In parallel, out-licensing arrangements have been executed for select biosimilar pipeline assets in international markets. These agreements structure Enzene as development and manufacturing partner, with commercial partners managing in-country registration and distribution. This capital-efficient model generates milestone and royalty revenue streams while extending Enzenes commercial reach across regulated and semi-regulated geographies without requiring direct market infrastructure.
EnzeneX™ 2.0 — Fully-Connected Continuous Manufacturing Platform
Enzenes patented EnzeneX™ platform is the worlds first fully-connected continuous manufacturing (FCCM) technology validated for commercial biologics supply. During FY 2025-26, the next-generation EnzeneX 2.0 was deployed at the Hopewell, New Jersey facility, and the platform received the CPHI Pharma Award for Manufacturing Excellence — recognition from an independent industry panel of its contribution to advancing bioprocessing and reducing the cost of biologic medicines globally.
The platform harnesses intensified perfusion using alternate tangential flow (ATF) and automated multi-column chromatography to achieve continuous, uninterrupted biologics production. Its modular and scalable design enables clients to adapt production volumes without changing core equipment, reducing both capital requirements and time-to-scale.
| Feature | Continuous Manufacturing (EnzeneX™ 2.0) | Fed-Batch Manufacturing (Traditional) |
| Input / Output | Continuous feed; continuous product harvest; steady- state 24/7 operation | Intermittent feed at intervals; discrete batch |
| Productivity | 10x higher upstream productivity; 25–50% improvement in downstream processing | Moderate — constrained by batch cycle time and turnaround intervals |
| Cost of Goods | Target: below $40 per gram for mAbs | Typically significantly higher cost per gram |
| Capital Expenditure | Lower — smaller footprint achieves equivalent or superior output | Higher — larger, more capital-intensive facility required |
| Environmental Footprint | 50–60% lower carbon footprint than conventional biomanufacturing | Higher energy and material consumption per production cycle |
| Scalability | Modular scale-on and scale-out; output adjusted by varying flow rates within existing equipment | Scaled by increasing bioreactor number or size; requires additional capital investment |
The EnzeneX platform is a core differentiator in Enzenes CDMO and biosimilar offering. Its deployment at both the Chakan (Pune) and Hopewell (New Jersey) facilities provides clients in India, North America, and Europe with access to manufacturing technology that delivers superior yield, lower cost of goods, and a materially reduced environmental footprint compared to conventional approaches. The CPHI Manufacturing Excellence Award received in FY 2025-26 provides independent third-party validation of the platforms industry-leading capabilities.
Plant Locations
| Entity | Location | Capability | Regulatory Status |
| Enzene Biosciences Limited | Chakan Industrial Area, Pune, Maharashtra, India | 20L to 200L capacity Drug substance and drug product manufacturing; CDMO; R&D | EU GMP certified (both Pune facilities); EMA-approved supply; global client and regulatory body audits completed |
| Enzene Inc. | Princeton West Innovation Campus, Hopewell, New Jersey, USA | Clinical and commercial biologics CDMO; EnzeneX™ 2.0 continuous manufacturing; | 80,000 sq ft facility inaugurated September 2025; GMP operational; |
R&D capabilities
Enzenes R&D capabilities are integrated within its Chakan (Pune) manufacturing campus and aligned with Alkems broader R&D ecosystem. The R&D function covers the full spectrum of biologics development, including: x Cell line development and clone selection. x Upstream and downstream bioprocess development and optimisation. x Advanced analytical and bioanalytical characterisation of drug substance and drug product. x Drug product formulation development and fill-finish process development. x Clinical and regulatory documentation to support multi-market dossier submissions (India CDSCO, European EMA, and other regulated markets).
Medtech
FY 2025-26 marked a defining year for Alkem MedTech Pvt Ltd, a wholly owned subsidiary of Alkem Laboratories, as the Company transitioned from a developmental-stage entity into an integrated, multi-segment medical devices platform. Business reach is spread across both India and global reach. The Company executed a series of decisive strategic moves including: x Completing the integration and merger of Bombay Ortho into Alkem MedTech x Announcing the proposed acquisition of a controlling stake in Occlutech (Germany) to enter the structural heart cardiovascular segment x Launching new orthopedic products, and initiating its Rest-of-World (RoW) regulatory and commercial strategy. These strategies are aimed at achieving the ambition of becoming a leading Indian-origin medical devices company in two priority segments, namely, musculoskeletal and cardiovascular, anchored on the pillars of ‘Innovative, Affordable, Accessible.
Key Strategic Actions in FY 2025-26
1. Integration and Merger of Bombay Ortho into Alkem MedTech
During the year, the Company completed the operational integration and statutory merger of Bombay Ortho, a Rajkot-based orthopedic implants manufacturing entity, acquired in FY 2024-25, into Alkem MedTech Pvt Ltd. The merger consolidates manufacturing, product development, regulatory ownership, intellectual property and commercial operations under a single entity, simplifying governance and unlocking operational synergies.
2. Foray into Cardiovascular: Proposed Acquisition of a Majority Stake in Occlutech
Alkem MedTech announced the proposed acquisition of a 55% controlling stake in Occlutech, a Germany-headquartered structural heart implants company, founded in 2003 and present across 20+ developed markets. Occlutech is the #2 player in Europe in the Atrial Septal Defect (ASD) and Patent Foramen Ovale (PFO) Occluder categories, with CE and US FDA approvals on flagship products and a clinical legacy of over 200,000 implants. The transaction provides Alkem MedTech with an immediate, credible entry into the global cardiovascular segment, specifically structural heart, a category characterized by long approval timelines, deep clinical evidence requirements and a high entry barrier. Occlutech has direct presence and approvals in the United States, European Union, Japan, Canada and broader RoW markets where greenfield entry would otherwise take 7–10 years and significant clinical investment. The brand has established a strong equity among global KOLs with two decades of clinical evidence, peer-reviewed publications and surgeon advocacy.
Structural heart is a high-growth, underpenetrated sub-segment. The global structural heart closure devices market is currently estimated at approximately USD 2.2 Billion with Occluders accounting for around 30%. Occlutechs manufacturing, regulatory and clinical infrastructure forms a launch pad for adjacent structural heart and interventional cardiology categories, including TAVI, IVL and stents, either through internal R&D, licensing or further M&A.
Occlutechs portfolio (ASD, PFO, AFR) is currently not available in India. The transaction provides Alkem MedTech with a defined path to introduce these products into India through CDSCO registration and to optimize global landed cost via partial India-localization of manufacturing.
3. New Product Launches in the Orthopedic Portfolio
In line with the FY 2024-25 commitment to evolve from foundational build to active market participation, the Company launched the several new products during FY 2025-26, including: x Modular Tibial Base Plate (MTBP): A modular knee platform offering enhanced intra-operative flexibility for surgeons in revision and complex primary cases. x TiNiBn-coated Knee System: A total knee implant featuring a Titanium-Niobium-Nitride surface coating, intended to address clinical needs in younger and metal-sensitive patient cohorts and to expand the Companys product range across the knee category.
x Primary Uncemented Hip System: Adding to the Companys primary Knee portfolio, the primary uncemented hip system aligns with global usage trends where uncemented constructs already account for the majority of primary total hip replacements.
4. Initiation of the RoW Strategy for Ortho
During the year, the Company initiated a structured Rest-of-World (RoW) regulatory and commercial entry strategy, with prioritized selected markets including the key approval like EU-MDR registration applications for the Knee and Hip implant systems are in process, alongside dossier preparation. USFDA establishment registrations have already been completed for the Continuum-of-Care surgical products SafeLavage and SafeTrion. The RoW pathway has been chosen to balance time-to-revenue with regulatory complexity.
5. Quality, Compliance and Manufacturing Excellence
FY 2025-26 was a year of significant uplift in the Companys quality, compliance and manufacturing architecture
Awarded ISO 13485:2016 certification for medical devices Quality Management System, validating end-to-end design, manufacturing and post-market processes against the global benchmark.
Strengthened QMS at the Rajkot manufacturing plant with reinforced design history file (DHF) discipline, CAPA closure rigor, supplier qualification protocols, and audit readiness for CDSCO, EU MDR and other key regulatory bodies.
Enhanced supplier ecosystem with onboarding of additional indigenous and international suppliers across instrumentation, raw materials and sterile packaging — reducing single-source risk, improving lead times.
Commissioning of high-end CNC machines from Germany and Japan, enabling tighter tolerances and improved throughput on complex implant geometries;
Induction of ultrasonic cleaning systems for surgical-grade finishing, supporting compliance with EU MDR and USFDA expectations on bioburden and particulate control;
Progression of automation across robotic grinding, polishing and finishing lines, reducing manual intervention and improving consistency;
Completed implementation of SAP across core manufacturing and quality processes at Rajkot plant. x Installed capacity remains aligned with the projected demand for Knee and Hip implants over the medium term, with modular blueprints in place to scale capacity meaningfully as Indian and global volumes ramp.
6. Medical Education and Launch of the Alkem MedTech Learning Lab
Recognizing that safe and effective use of medical devices is enabled through structured, science-led professional education, the Company launched the ‘Alkem MedTech Learning Lab during the year as a dedicated medical education platform. The Learning Lab is built on three pillars:
x Skill development for safe and effective device use: Structured cadaveric workshops, hands-on simulation modules and procedural training programmes for orthopedic specialists, focused on appropriate technique, patient selection and complication management.
Training of allied healthcare professionals: Certificate-led modules for operating-room nurses, biomedical and bio-engineering staff and technicians, supporting the broader continuum of safe device handling, instrument processing and post-operative care. x Physician education on disease management: Clinical evidence updates, disease awareness sessions and CME-style scientific exchange covering osteoarthritis, joint preservation strategies and emerging treatment pathways.
During the year, the Alkem MedTech maintained an active scientific presence across all major orthopedic conferences in India, including national and regional academic congresses and speciality associations. The participation focused on scientific exchange, sponsored academic sessions and showcasing the launched portfolio comprising MTBP, the TiNiBn Knee and the Primary Uncemented Hip. The Company also progressed clinical collaboration discussions with leading multi-specialty hospitals for Real-World Evidence (RWE) and Post-Market Clinical Follow-up (PMS) studies on its implant portfolio.
FY 2025-26 was a year of strategic compounding for Alkem MedTech with the Bombay Ortho integration consolidating the Indian Orthopedic platform, the proposed Occlutech transaction opening a credible global cardiovascular trajectory, new product launches strengthening the clinical bag, and quality, regulatory and manufacturing systems reaching global benchmark standards. The Company is now well-positioned to scale into its next phase, from a foundational MedTech entrant to a globally relevant, India-anchored medical devices platform across musculoskeletal and cardiovascular. The Company remains committed to its purpose of ‘Advancing Medical Technology Solutions for a better Tomorrow.
GLP-1 Injectable
The Company launched semaglutide injection in India under the brand names "Semasize", Obesema" and "Hepaglide". Semaglutide pre-filled disposable injection pen with price starting • 1,800 for monthly dosage provides affordable pricing. This is likely to lower barriers to initiation and expand access to this therapy in India. Apart from disposable pen, Alkem is offering reusable injection pen for semaglutide administration for higher maintenance doses. The reusable pen enables patients to replace only the medication cartridge rather than purchasing a new disposable pen each time, thereby reducing cost and helping better patient adherence to treatment. Alkem has received approval from the Drug Controller General of India (DCGI) for manufacturing and marketing semaglutide for type 2 diabetes mellitus and chronic weight management as an adjunct to diet and exercise, subsequent to a review of its Phase 3 clinical trials conducted in India.
Alkem ActivLife
Alkem ActivLife represents the Companys strategic entry into the rapidly expanding consumer health and wellness segment, with a clear ambition to build a scaled, future-ready preventive healthcare business. Anchored in the strong equity of the ‘A to Z franchise, the division is focused on addressing the rising consumer need for daily health management, energy, immunity, and lifestyle-led wellness solutions. As India witnesses a structural shift towards preventive and self-care health, Active Life is uniquely positioned to leverage Alkems medical credibility, distribution strength, and brand trust to build a differentiated play in this high-growth category.
The division is guided by a clear ambition to significantly scale the business over the next 3–5 years, with a focus on building leadership in the wellness segment.
Key strategic pillars include:
Building a scaled wellness franchise: Strengthening the core multivitamin business while expanding into high-growth adjacencies such as cardiovascular health, womens wellness, and vitality solutions. Premiumization & innovation: Introducing
advanced formulations with targeted delivery and differentiated delivery formats to drive category upgrade and consumer preference.
Doctor to consumer continuum: Leveraging strong prescription equity to drive consumer adoption, and bridging Rx credibility with OTC scale.
Omnichannel expansion: Expanding presence across modern trade, e-commerce, and general trade, supported by focused trade marketing initiatives.
Brand modernization: Repositioning legacy brands to connect with younger, health-conscious consumers while retaining trust among existing users.
Brand portfolio: The Active Life portfolio comprises a diversified range of science-backed nutritional supplements, catering to multiple health needs:
x A to Z Tablets: Flagship multivitamin brand with strong prescription heritage.
A to Z Syrup & Drops: Leading pediatric nutrition solutions with strong growth momentum.
A to Z Gold: Focused on early diagnosed diabetes and cardiovascular health.
A to Z CV: Focused on advanced cardiovascular nutrition.
A to Z Woman: Targeted solution addressing womens health and nutritional needs.
A to Z Amino: Positioned in the energy and recovery space, witnessing strong traction.
Key developments during FY 2025-26 include:
The A to Z portfolio surpassed the leading competitor in IQVIA, marking a significant milestone in market leadership. x Achieved #1 position in the Syrup & Drop segment.
Secured top position in prescription generation (SMSRC) across 3 SKUs, reflecting strong doctor endorsement.
Strengthened portfolio with new launches and upgraded formulations, including A to Z CV and reformulated Drops.
Expanded trade marketing footprint across key metros and emerging towns.
Set-up e-commerce channel across marketplace, Q-comm, and social media presence.
Launched A to Z Daily and developed an hinglish rap film that mirrors everyday hustle through an AI-led visual narrative. The film garnered 10 Million impressions in its launch stage.
A host of new products are set to be launched under A to Z Expert range for precision nutrition like Smart Sprinkle for Kids and Adults, Omega Triple Strength, Triple complex Magnesium, Vit D+B12, Iron Chewables, A to Z Sure, etc. The ActivLife division is well-positioned to capitalize on the strong tailwinds in Indias wellness market, driven by increasing consumer awareness, lifestyle changes and a shift towards preventive healthcare. The division aspires to scale significantly over the next 3–5 years, with a long-term ambition to build a leading wellness franchise of meaningful size and market leadership. This growth will be driven by expansion into new categories and formats, strengthening both Rx & OTC acquisition funnel, increased investments in brand building and digital engagement and continued focus on innovation and differentiated offerings.
With a strong foundation and clear strategic direction, Alkem ActivLife is poised to become a key growth driver for the Company and a leading player in Indias evolving wellness landscape.
API – Alkem Activa
Alkem Activa is the API Division of Alkem, representing a pivotal step in strengthening Alkems global API presence. Rooted in a legacy of pharmaceutical excellence, Alkem Activa focuses on delivering innovative, reliable, and sustainable healthcare solutions through high-quality APIs backed by green chemistry and continuous manufacturing to drive next-gen healthcare solution. Alkem Activa maintains a diverse portfolio of APIs, categorized by their market potential and regulatory acceptance. Key products and categories include controlled substance and psychostimulants which are the primary contributors to sales value.
With 3 USFDA-approved sites, a talent pool of 70+ scientists, and a manufacturing capacity of 500KL reaction volume, Alkem Activa stands as a trusted partner for pharmaceutical companies worldwide. Alkem Activas expanding portfolio includes a diverse range of APIs across multiple therapeutic categories—including cardiovascular, CNS, gastrointestinal, and more.
Alkem Activas growth strategy centers on several key pillars: x Backward integration for captive formulation: Leveraging its strong R&D and API manufacturing capabilities for captive requirements, to strengthen new formulation launches and acts as a risk mitigation strategy. x Global regulatory compliance: A primary focus is the simultaneous development of all APIs for global regulatory standards, specifically targeting USDMF, ASMF, CEP, CADIFA filings x International footprint: There is a strong emphasis on driving third-party sales momentum by acquiring new customers and expanding market presence in regulated market such as USA, Europe, Latin America and more. x Manufacturing capability in USA for schedule I and II API provide an advantage to Alkem Activas growth strategy in the USA market x Initial steps have been to build CDMO pipeline, including engaging with customers and aligning internal teams across R&D and manufacturing
Key Developments: x Total API sales including captive reached — 100 Crore in FY26, up 26% Y-o-Y x Third-party sales grew from — 23.67 Crore to — 32 Crore x Regulatory filing: Received CEP approvals for 4 APIs and filed 2 USDMFs x Customer Acquisition: Added 74 customers. Drug Master Files (DMFs) provided to 39 customers and samples seeded to 35 customers globally. Key customers added in Brazil, Europe, India, South Korea and more.
Outlook
The growth outlook for Alkem Activa is highly positive, with several priorities set for the upcoming fiscal years through product expansion, increased regulatory filing, and deeper engagement with global customer. Alkem Activa has partnered with key global pharmaceutical companies for their upcoming launches. The R&D roadmap includes the development of complex molecules and also support development of New Chemical Entities under CDMO model, slated for launch over the next several years. Alkem Activa has set ambitious goals including achieving process optimization, strengthening execution across manufacturing, regulatory, supply chain & logistics function in order to achieve steady future growth. With clear strategic direction and strong foundational capabilities, Alkem Activa aims to be a major player and trusted partner in APIs globally.
5. Research and Development:
Clinical Research
The Companys state-of-the-art clinical research facility not only focuses on bioequivalence and bioavailability studies but is also licensed to conduct first-in-human and early-phase (Phase I) studies. Leading regulatory agencies, including the USFDA, UK MHRA, EMA, ANVISA, NPRA-Malaysia and CDSCO have inspected the facility. In March 2025, the facility successfully cleared the Bioresearch Monitoring (BIMO) inspection conducted by the USFDA, with no Form 483 issued, underscoring Alkems commitment to global compliance and data integrity.
Advancing Global Clinical Development Capabilities
The Company has a proven track record in conducting scientifically robust clinical trials across all phases (Phase 1 to Phase 4) and in a variety of therapeutic areas including infectious disease, oncology, endocrinology, neurology, cardiology, hematology, rheumatology, ophthalmology and gastroenterology. The team possesses deep expertise in conducting clinical studies involving both small and large molecules, including stem cell-based products, supporting regulatory submission to domestic as well as major regulated markets such as the US and EU.?
These studies are executed in strict compliance with ICH-GCP and international guidelines and regulations, with a core focus on addressing unmet healthcare needs and generating high-quality data to support the development of safe and effective novel therapies.
The team has an ability to integrate scientific excellence with operational agility while adhering to robust regulatory standard, adoption of innovative trial design which enhance efficiency and improve patient access and generate high-quality data. Patient centricity and innovation driven approach remains at the core during clinical development, incorporating patient insights in to study design, improving diversity, reducing patient burden and enhancing trial participation.
Driving Global Innovation & Research Partnerships
In addition to these collaborations, Alkem is also driving innovation internally across a range of therapeutic areas. Many of these development programmes have successfully advanced to Phase I and Phase II clinical trials. Alkem has established strong and robust intellectual property (IP) around these innovations, further strengthening its position as a leader in novel and differentiated drug development.
Alkems innovation journey started by strategically collaborating with leading academic institutions in the US and India. Globally, the Company collaborates with esteemed organizations such as Harvard University, Johns Hopkins University, National Institutes of Health (NIH), USA and Karolinska Institute (Sweden). In India, Alkem partners with top-tier institutes, including IIT Bombay, IIT Kanpur, IISc Bangalore and Tata Memorial Hospital.
The objective is to foster innovation by supporting cutting-edge research through strategic partnership in areas of significant clinical unmet need. Eventually, these strategic R&D partnerships lead to the identification of novel therapeutics targeting cancer, peripheral diabetic neuropathy, vascular ischemia and others.
Alixer Nexgen Therapeutics Ltd, a wholly owned subsidiary of Alkem, is focused to develop these novel assets through global regulatory development, with the goal of advancing them to IND submissions and early human proof-of-concept studies. The product pipeline includes novel biologics currently undergoing IND-enabling studies, with various regulatory interactions being initiated with the US FDA. We have also progressed a novel, globally patented product developed indigenously, into the mid-clinical stage for the treatment of allergic rhinitis.
This innovation portfolio is protected by a robust intellectual property strategy, comprising 6 granted patents and 55 pending patent applications globally.
Innovation Pipeline
| Program | Modality | Therapeutic Indication | Development Stage |
| ALDP001 | Novel Small Molecule | Seasonal & Perennial allergic rhinitis | Phase-2 |
| ALDP021 | Novel Small Molecule | Seasonal & Perennial allergic rhinitis | Preclinical (IND Studies) |
| ALK-201 | Novel Biologics | Colorectal Cancer | Preclinical (IND Studies) |
| ALK-202 | Novel Biologics | Vascular Ischemia of lower extremity in diabetic patients | Preclinical (IND Studies |
Ensuring Patient Safety & Risk Management
The Company has a robust and well-established pharmacovigilance system to continuously monitor, assess, and review the safety profile of its medicines throughout their entire lifecycle, including both clinical development and post-marketing phases. This framework supports the timely detection, evaluation, understanding, and prevention of adverse events and other product-related risks, ensuring that patient safety remains a core priority at all times.
The Company continuously evaluates the benefit-risk profile of its marketed products to confirm that the therapeutic benefits outweigh any potential risks. It is also committed to maintaining transparency in communicating relevant safety information, benefits, and risks to patients, healthcare professionals, and regulatory authorities, reflecting its dedication to responsible healthcare practices and regulatory compliance.
Bridging Science, Evidence & Growth
The Companys science-led growth is driven on evidence-based product adoption, advancing medical education, and strengthening stakeholder engagement. During the year, key product introductions, included semaglutide, pertuzumab, and other advanced therapies across metabolic and priority disease areas, through robust scientific positioning, targeted educational initiatives, and post-launch evidence generation through the Companys scientific pillar, medical affairs.
All activities are executed in strict alignment with applicable regulatory requirements and the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), ensuring ethical, transparent, and compliant scientific exchange across the product lifecycle.
6. Operations
Operational initiatives during the year supported cost control and consistent product supply.
Manufacturing efficiency
The Company operates 20 state-of-the-art manufacturing facilities across India and the United States of which 5 are USFDA approved. All facilities are regularly audited and approved by global regulatory bodies including the US FDA, WHO, MHRA (UK), TGA (Australia), ANVISA (Brazil) and SAHPRA (South Africa). The Company has: x Filed 192 ANDAs, 2 NDAs and 1 BLA with the US FDA x Received approvals for 167 ANDAs (including 19 tentative approvals) and 2 NDAs x Registered 1,100+ products across various international markets
The Company has three advanced R&D centers with 595+ scientists focused on differentiated, first-to-market products. To support its manufacturing capabilities, the Company has built a strong supply and distribution network comprising 11 central warehouses, 73 sales depots and CFAs and 8,800+ stockists.
Quality focus
The organization successfully underwent multiple regulatory inspections and audits during the reporting period. Two EU regulatory audits were conducted, and clearance certificates were received, confirming compliance with EU GMP requirements. These outcomes reflect a robust quality management system, sustained inspection readiness, and strong cross functional collaboration. In addition, internal and external audits were executed as per plan, with observations addressed through timely and effective CAPA implementation.
Quality function focused on strengthening compliance, enhancing operational excellence, and embedding a culture of continuous improvement across manufacturing and quality systems. Key initiatives included reinforcement of investigation quality, risk-based decision making, and enhanced oversight of critical quality events such as deviations, OOS, CAPA, and market complaints.
Significant improvements were implemented across quality systems and processes to enhance efficiency, control, and data reliability. Procedures related to deviation management, OOS investigations, CAPA effectiveness checks, change management, and document control were reviewed and strengthened. Digital tools and structured trackers were leveraged to improve real time monitoring of quality metrics, reduce turnaround times, and increase transparency and accountability.
To further strengthen quality performance and regulatory compliance, the following key initiatives were implemented during the year:
x Quality Improvement Plan (QIP): A structured QIP was rolled out to reduce recurring deviations and OOS events and to improve CAPA effectiveness. Key risk areas were identified through trend analysis, and targeted action plans were implemented with defined timelines, owners, and governance.
Process and System Strengthening: Investigation practices, change management, and document control were enhanced to improve right first-time performance, strengthen compliance, and reduce cycle times.
Digitalization and Process Simplification: Progress continued toward digitization of quality systems to strengthen data integrity, traceability, and real time tracking of quality events, including:
Digitalization of in process checks: Extended for imprinting, coating, and laser drilling stages to improve process accuracy and traceability.
x Validation lifecycle management: Extended for facility qualification, server qualification, and QC instrument qualification modules to improve traceability and digitization.
Backup solution: Image based backup system implemented to support business continuity and data security.
People centric initiatives such as the Buddy Programme supported smooth onboarding and capability building for new joiners, while the Idea Bank and Kaizen initiatives encouraged innovation and employee participation. These programmes contributed to waste reduction, improved efficiency, and sustained regulatory compliance.
Training and Capability Building: Focused training programmes on regulatory expectations, enhanced cGMP practices, and data integrity were conducted to strengthen employee competency and compliance awareness. A new Learning Management System (LMS) was implemented to strengthen training governance and improve training compliance.
These initiatives have contributed to improved compliance status, enhanced inspection outcomes, reduced quality risks, and strengthened confidence of regulatory authorities and stakeholders. The organization remains committed to continuous quality improvement and sustaining global regulatory standards.
Regulatory compliance
All manufacturing facilities are in accordance with a broad spectrum of international Good Manufacturing Practices (GMP), including but not limited to:
x Schedule M (India) x 21 CFR (United States) x Eudralex Volumes (European Union) x WHO-GMP (World Health Organisation) x Orange Book (UK MHRA) x TGA GMP guidance (Australia)
All developed, manufactured, and distributed products strictly adhere to the legal and quality requirements of target markets in accordance to the QMS framework.
Supply chain reliability
Global geopolitical instability has led to significant supply chain disruptions with high volatility in oil pricing, increased cross border shipping lead times and increased transportation costs etc. The Company is undertaking appropriate measures, on ongoing basis, to ensure market relevance and competitiveness.
Advance planning: To ensure uninterrupted supply of goods or services the Company ensure advance strategic planning. Planning plays a crucial role especially amidst global uncertainty leading to shortage of goods. The Company is striving tirelessly to forecast, plan in advance and work in close association with its partners to secure adequate manufacturing slots.
Inventory: Basis the potential market price movements inventory levels are handled across the value chain at one of the following:
x Raw Material level inventory x Finished goods level inventory x Inventory by Suppliers
Strategic purchase: The Company has adopted a strategic approach in securing supplies rather than undertaking tactical purchases. Strategic Supplier Relationship Management (SRM) programme is adopted on an ongoing basis.
Risk Mitigation: A well-established formal process of quarterly material risk mitigation programme is in place. In addition, the Company has also adopted supplier risk mitigation programme with a help of an established external agency to be able to predict potential risks at supplier end.
Digitalisation: The Company has robust ERP tools and bidding tools such as SAP HANA and SAP Ariba. In addition, the Company has also introduced a bidding tool for Direct materials, during the year. This AI enabled tool is user friendly for partners, further enabling their decision making process.
IT & Digitization
The IT function supported Alkems growth and operational priorities by strengthening the enterprise digital foundation, standardizing core platforms, enhancing cybersecurity and compliance, and expanding data-led decision-making across functions and geographies.
Key milestones included
2The successful completion and stabilization of Project EKAM, which migrated all field and non-field users onto a single Microsoft 365 environment to create a unified, secure and scalable digital workplace.
Project EKAM also continued the progress towards a unified SAP HANA platform to enhance end-to-end visibility, strengthen controls and standardize processes across the value chain in both domestic and international operations.
Project Aspire strengthened enterprise visualisation and analytics capabilities, supporting faster and more consistent decision-making across functions.
Strengthened its digital manufacturing landscape through targeted Level-2 (L2) system integration initiatives, aligned to compliance, data integrity, patient safety and smart manufacturing principles.
Digital manufacturing, analytics and employee enablement agenda were further advanced through compliance-driven integrations, smart-factory capabilities and early AI-led initiatives, reinforcing long-term resilience and scalability.
Key outcomes from project EKAM included:
Onboarded ~22,000 employees (field and office) onto a common platform, enabling a consistent sign-in experience across enterprise applications.
Enabled secure mobile access to corporate applications through Intune Mobile Application Management (MAM), strengthening mobility with appropriate security and compliance controls.
Centralized access to enterprise applications via MyApps, supporting single sign-on and uninterrupted cross-system usage.
Standardized identity and access management to improve governance, enhance security posture and simplify IT operations.
With a unified digital workplace in place, Alkem is better positioned to scale collaboration and productivity, and to adopt future capabilities such as Microsoft Copilot, enterprise automation and modern digital workflows.
Key milestones of unified SAP HANA platform include:
Onboarded Pharmacor Australia, Ascend Chile, and Ascend USA and Norac USA entities onto a unified SAP instance, enabling consistent processes and reporting structures.
Harmonized master data, workflows and control frameworks to improve efficiency and governance.
Improved transparency across finance, supply chain operations and compliance reporting to support timely decision-making.
This initiative is an important step towards a scalable, globally integrated ERP landscape.
Key developments in Project Aspire include:
Additional dashboards were enabled for the subsidiaries such as Alkem Wellness and Adroit
Dashboards and automated mailers with key insights for actions Collectively, these capabilities enhanced cross-functional visibility, improved sales planning and review and drove a data-driven culture.
Key focus areas of targeted Level-2 (L2) system integration initiatives include:
Strengthened compliance aligned with 21 CFR Part 11 and ERES, including access controls, data security, backups and periodic GAP assessments.
Integrated manufacturing systems with enterprise platforms to enable centralized monitoring, L2-to-L3 data flow and audit-ready data integrity. x Enabled IoT-based predictive maintenance and energy optimization, along with AI-enabled QMS and R&D workflows.
x Upgraded infrastructure and operating systems, improved network performance and backup capabilities, and deployed smart racks to strengthen reliability and safety.
These initiatives enhanced compliance readiness, improved operational visibility and strengthened manufacturing resilience.
AI initiatives: Building foundations for quality excellence
Alkem initiated select AI-led use cases focused on quality excellence and continuous improvement. The intent is to identify patterns, enable proactive monitoring and build a scalable foundation for advanced analytics-led insights aligned with regulatory expectations.
GCC enablement: Strengthening onboarding and employee experience
Alkem advanced Global Capability Center (GCC) enablement with a focus on employee onboarding and lifecycle readiness. Process improvements, targeted automation and system integration helped accelerate onboarding, enhance employee experience and strengthen governance across the employee lifecycle.
Priorities ahead
Looking ahead, Alkem will continue to strengthen core technology platforms while scaling digital capabilities that support security, compliance, productivity and operational excellence.
x Ensure the benefits of the technology investments are fully realized and user adoption is further enhanced x Focus on reskilling and making our employees AI ready x Centralized ERP and supply chain optimization: Build on the unified ERP foundation to enhance supply chain planning, improve processes and support planned technology upgrades. x Expansion of AI-led initiatives: Scale AI initiatives across quality, manufacturing and supply chain to enable predictive insights, automation and faster decision-making. x Cybersecurity and OT security: Continue to enhance enterprise cybersecurity, with emphasis on Operational Technology (OT) security across manufacturing environments through governance, monitoring and awareness programmes.
7. Financial Performance:
The financial performance for the year reflects: x Growth in revenues across key segments x Improvement in margins, supported by product mix and cost measures x Stable cash flow generation The Company continues to focus on maintaining financial discipline and improving capital efficiency.
Key Profit and Loss Statement Highlights
| Particulars | FY 2025-26 | FY 2024-25 | YoY Change | Comments |
| Revenue from operations | 147,123 | 129,645 | 13.5% | Domestic business grew by 9.7%. The US business grew by 20.3% YoY. The strong growth was mainly on account of continued growth traction in new launches and volume increase and also including revenue from Enzene CDMO business. |
| Other International Markets registered strong growth of 26.7% led by key markets of Europe, Australia and LATAM. | ||||
| Gross Profit | 96,195 | 82,003 | 17.3% | |
| Gross Profit % | 65.4% | 63.3% | Gross margin was improved mainly due to lower API prices and better product mix across geographies. | |
| EBITDA | 30,052 | 25,122 | 19.6% | |
| EBITDA % | 20.4% | 19.4% | ||
| PBT before exceptional item | 30,457 | 25,270 | 20.5% | |
| Exceptional Item | (1,748) | - | - | There was an exceptional item of › 1,748 million mainly due to amendment in the labour laws. |
| PBT after exceptional item | 28,708.9 | 25,270.3 | 13.6% | |
| PBT margin | 19.5% | 19.5% | ||
| PAT (After Minority Interest) | 23,018 | 21,655 | 6.3% | |
| PAT margin | 15.6% | 16.7% |
| Key Ratios | |||
| Ratio | Formula used | FY 2025-26 | FY 2024-25 |
| Debtors Turnover Ratio | Sale of products/Trade receivables | 4.88 | 5.19 |
| Inventory Turnover Ratio | COGS/Inventory | 1.53 | 1.63 |
| Interest Coverage Ratio | EBIT/Finance Cost | 16.32 | 17.71 |
| Current Ratio | Current Assets/Current Liabilities | 2.55 | 2.73 |
| Debt to Equity Ratio | Net Debt/Total Equity | 0.10 | 0.06 |
| Operating Profit Margin (EBITDA Margin) | EBITDA/Revenue from Operations | 20.4% | 19.4% |
| Net Profit Margin | PAT/Revenue from Operations | 15.6% | 16.7% |
Adherence to Accounting Standards:
The Company continues to adhere to standard accounting policies under the Indian Accounting Standards ("Ind AS"), applicable since 01 April, 2016. IND AS 116 pertaining to Leases was the sole addition under Section 133 of the Companies Act, 2013. These policies are to be read along with the relevant applicable rules and accounting principles. Changes in policies, if any, are approved by the Audit Committee.
8. Risks and Concerns
The Companys robust Enterprise Risk Management (ERM) framework is equipped to successfully identify, assess, and mitigate both internal and external risks arising due to diversified operations across geographies. Timely and proactive risk management enables to the Company take appropriate decisions and thus preserve long-term value for stakeholders.
The Risk Management Committee, constituted by the Board of Directors, is responsible for strategic oversight and governance of risk management activities. This Committee ensures that key business, financial, operational, strategic, regulatory, and cyber-related risks are systematically identified and mitigated through structured response plans.
With a view to foster a risk-aware culture, the ERM function collaborates closely with business and functional leaders. Emerging threats are attempted to be recognized by closely monitoring internal and external developments continuously.
Key elements of Alkems risk management approach include: x Regular risk assessments and reviews x Integration of risk considerations into strategic planning and operations x Real-time monitoring of key risk indicators (KRIs) x Periodic reporting to the Risk Management Committee and the Board The table below summarizes key risk categories along with corresponding mitigation strategies:
| Risk Category | Potential Impact | Mitigation Strategy |
| India Pricing and DPCO Risk | Expansion of price-controlled medicines under DPCO could impact revenue and margins across parts of the domestic portfolio. | Diversification towards chronic, specialty and OTC products, stronger branded positioning, and active engagement with industry associations to address regulatory developments. |
| US Generic Pricing Pressure | Sustained pricing erosion in the US generics market may compress margins on established products. | Focus on complex and differentiated generics, niche molecules, and first-to-file/first-to-market opportunities to improve product competitiveness. |
| Regulatory and cGMP Compliance | Non-compliance with global regulatory standards could result in import alerts, warning letters, product recalls, or restricted market access. | Robust quality systems, regular self-inspections, digital quality management platforms, and sustained compliance across manufacturing facilities. |
| Occlutech M&A Integration | Integration challenges relating to operations, governance, culture, and regulations could affect value realisation from the acquisition. | Dedicated integration leadership, Board oversight, milestone-based integration plan, management continuity, and prudent capital structure. |
| Climate Change and Environmental Risk | Climate events, evolving regulations, and sustainability expectations could disrupt operations, increase compliance costs, and affect market access | Enterprise-wide EHSS framework, renewable energy adoption, resource efficiency initiatives, emissions tracking, and strengthened sustainability disclosures. |
| Biosimilar Regulatory Timeline | Regulatory approvals, technology transfer, and client execution timelines could impact commercialisation of biosimilars and CDMO projects. | Early regulatory preparedness, diversified development pipeline, flexible out-licensing strategy, and investments in biologics manufacturing capabilities. |
| Supply Chain Concentration and Seismic Risk | Operational disruptions at key manufacturing sites due to natural disasters or supply chain interruptions could affect business continuity. | Inventory buffers, alternate manufacturing arrangements, emergency response systems, infrastructure resilience, and business continuity planning. |
| Risk Category | Potential Impact | Mitigation Strategy |
| Cyber Security and Data Integrity | Cyberattacks or IT system failures could disrupt operations, compromise regulatory submissions, and impact business continuity. | 24/7 security monitoring, network protection, access controls, employee awareness programmes, ISO 27001 implementation, and periodic security assessments. |
| Geo-political and Trade Policy Risk | Trade restrictions, tariffs, sanctions, and changing geopolitical conditions could increase costs and disrupt global supply chains. | Diversified manufacturing footprint, backward integration for critical APIs, active monitoring of trade developments, and multi-market registration strategy. |
9. Outlook:
According to IQVIA data, the Company outperformed IPM in seven therapies, which is anti-infective by 1.1X, Gastro-intestinal by 1.5x, Vitamins and minerals by 2x, pain/analgesics by 1.6x, antidiabetic by 1.2x, respiratory by 1.4x and derma by 1.8x. This outperformance underscores the Companys strong market position in the IPM. The Company remains well placed to leverage its strong fundamentals to tap the opportunities ahead, supported by expanding portfolio, upcoming launches and investments in the new growth areas. The Company continues to navigate the evolving operating environment with agility and resilience.
In the international market, the Company is strengthening its grip by expanding into newer geographies and gradually expanding product portfolio. The Company is continuously monitoring the US business and remains committed to improve performance. Enzene is steadily gathering global relevance, and Alkem MedTech presents a solid platform to compete globally.
The Company remains dedicated to steadily building future growth engines across MedTech, biologics, injectables and specialized healthcare platforms. Alkem will continue to invest selectively in growth areas, undertake prudent cost management and remain agile amidst challenging macro environment. The Company is closely monitoring the fluctuations in raw material and freight costs, and is undertaking appropriate and timely action to manage costs prudently. The overall outlook remains stable, supported by a diversified business model and continued focus on execution.
Cautionary Statement
This document contains certain statements that are or may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and regulations. These statements include, but are not limited to, projections, estimates, expectations, plans, objectives, and assumptions regarding the Companys future performance, business strategies, operational initiatives, and industry conditions.
Such forward-looking statements are based on current assumptions, anticipated developments, and other factors that are subject to known and unknown risks, uncertainties, and other factors beyond the Companys control. These may cause actual results, performance, or achievements to differ materially from those expressed or implied in the statements.
Key factors that could affect performance include, but are not limited to: global and domestic macroeconomic conditions, regulatory changes, evolving competitive landscapes, technological advancements, successful execution of business strategies and growth plans, R&D outcomes, changes in customer and supplier dynamics, and developments in the pharmaceutical and MedTech industries.
The Company undertakes no obligation to update, revise, or amend any forward-looking statements to reflect events or circumstances arising after the date of this report, except as required under applicable law.
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