Slides
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Neuland Laboratories Limited Investor Presentation Q2FY27 & H1FY27
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Except for the historical information contained herein, statements in this presentation and the subsequent discussions, which include words or phrases such as "will", "aim", "will likely result", "would", "believe", "may", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", seek to", "future", "objective", "goal", "likely", "project", "should", "potential", "will pursue", and similar expressions of such expressions may constitute "forward-looking statements“. These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include but are not limited to our ability to successfully implement our strategy, our growth and expansion plans, obtain regulatory approvals, our provisioning policies, technological changes, investment and business income, cash flow projections, our exposure to market risks as well as other risks. The Company does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof. SAFE HARBOUR 2
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3 Table of Contents Q2FY27 Highlights Q2FY27 Highlights Company Overview Company Overview Shareholder Information Shareholder Information Business Strategy Business Strategy Our Businesses Our Businesses Annexure Annexure
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4 Q2FY27 & H1FY27 Highlights
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5 SAHARSH DAVULURI, CEO & MD “While we have experienced a dip in performance this quarter, H1 FY27 was largely in line with plan and our growth expectations remain intact for FY27 and the following year. Commercial CMS molecules continue to drive near-term growth, while strong RFP activity along with progress on traction with Big Pharma support customer diversification and the longer-term pipeline. The investments in peptides, R&D and land acquisition strengthen our capabilities while enabling us to expand with agility.” Management Commentary
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CMS CMS revenues driven by commercial molecules. Growth in new projects orders which will be delivered over the course of this and next financial years. Traction from Innovators with peptides molecules in pipeline. GDS In Prime segment, Ezetimibe and Mirtazapine were the key molecules. Ezetimibe likely to drive growth of the Prime segment. Specialty business driven by Deferasirox, Apixaban and Donepezil. 2 DMFs filed for Fezolinetant and Ivacaftor Financial Highlights Standalone revenue decreased 11.4% YoY to ₹457.2 Cr; commercial CMS projects contributed the majority share of revenue. EBITDA for the quarter stood at ₹104.6 Cr, with EBITDA margin reducing to 22.9% (down 754 bps YoY) due to operating deleverage. Profit After Tax for the quarter stood at ₹51.1 Cr, down from ₹96.5 Cr in Q2FY26, with PAT margin at 11.2% (down 751 bps YoY). Diluted EPS for the quarter was ₹39.9, compared to ₹75.2 in Q2FY26. Working capital efficiency improved meaningfully, with working capital days reducing to 104 days in H1FY27 from 155 days at H1FY26, driven largely by decrease in inventory days and receivable days. Capex investment cash outflow of Rs. 261 Cr is largely driven by New R&D and Peptide Block. 6 Q2FY27 Business Overview
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7 Q2FY27 Financial Highlights Total Income (Rs. Cr) EBITDA (Rs. Cr) PAT (Rs. Cr) EPS (Rs.) Financial Highlights • Total Income for Q2FY27 at Rs. 457.2 crore (-11.4% YoY) • EBITDA for Q2FY27 at Rs. 104.6 crore (-33.4% YoY) • EBITDA Margin for Q2FY27 at 22.9% (decreased by 754 bps YoY) • PAT for Q2FY27 at Rs. 51.1 crore (-47.0% YoY) • Net Debt stood at Rs. (208.0) crore as at Q2FY27 end compared to Rs. (6.6) crore as at Q2FY26 end and Rs (308.5) crore as at Q1FY27 end 516.1 447.8 788.7 650.1 457.2 Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 156.9 85 319.4 231.1 104.6 30.4% 19.0% 40.5% 35.5% 22.9% Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 EBITDA EBITDA Margin 96.5 40.1 212.5 147.4 51.13 18.7% 9.0% 26.9% 22.7% 11.2% Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 PAT PAT Margin 75.2 31.5 165.6 114.9 39.9 Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27
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8 H1FY27 Financial Highlights Financial Highlights 816.7 1107.2 H1FY26 H1FY27 Total Income (Rs. Cr) 199.1 335.6 24.4% 30.3% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 0.0 50.0 100.0 150.0 200.0 250.0 300.0 350.0 400.0 H1FY26 H1FY27 EBITDA (Rs. Cr) 85.9 154.7 H1FY26 H1FY27 EPS (Rs.) 110.2 198.5 13.5% 17.9% 0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0% 16.0% 18.0% 20.0% 0.0 50.0 100.0 150.0 200.0 H1FY26 H1FY27 PAT* (Rs. Cr) • Total Income for H1FY27 at Rs. 1107.2 crore (35.6% YoY) • EBITDA for H1FY27 at Rs. 335.6 crore (68.6% YoY) • EBITDA Margin for H1FY27 at 30.3% (increased by 594 bps YoY) • PAT for H1FY27 at Rs. 198.5 crore (80.2% YoY) • Net Debt stood at Rs. (208.0) crore as at H1FY27 end compared to Rs. (6.6) crore as at H1FY26 end
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Particulars (Rs Cr) Mar-23 Mar-24 Mar-25 Mar-26 Sept-26 Shareholder’s Funds 988.4 1267.5 1,517.8 1,865.9 2,020.5 Net Debt* 63.0 -32.6 -228.7 -156.8 -208.0 Tangible Assets (including CWIP)** 511.2 575.4 698.2 1,002.9 1185.9 Working Capital 463.0 525.4 440.6 773.0 628.5 9 Key Balance Sheet Metrics *Net debt includes investment in Mutual Fund in previous years. **Tangible assets includes investment property in previous years. 1.7 2.1 2.4 2.1 2.2 FY23 FY24 FY25 FY26 H1FY27 Current Ratio 0.10 0.10 0.10 0.10 0.12 FY23 FY24 FY25 FY26 H1FY27 Debt to Equity 21.3 32.8 17.9 26.1 24.3 FY23 FY24 FY25 FY26 H1FY27 ROCE% 2.7 3.1 2.3 2.6 2.4 FY23 FY24 FY25 FY26 H1FY27 Fixed Asset Turnover Ratio
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10 • CMS business caters to Innovator customers on an exclusive basis, developing and manufacturing APIs/Intermediates in line with rigorous customer expectations hence is highly concentrated in terms of customers • Specialty segment works on complex products and technologies, hence has a focused approach towards select customers Key Operating Metrics Q2FY27 Segment revenue Top 10 & Top 5 Products Top 10 & Top 5 Customers 26% 22% 18% 18% 30% 11% 11% 8% 8% 10% 60% 61% 68% 67% 53% 4% 6% 6% 6% 8% Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 Prime Specialty CMS Others 93% 92% 99% 71% 71% 61% 94% 57% Prime Specialty CMS Company Top 10% Top 5% 98% 81% 99% 82% 83% 62% 96% 68% Prime Specialty CMS Company Top 10 Top 5
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• Pre-clinical to P-3: Neuland generates revenue by process research & development as well manufacturing quantities for clinical trials • *Pre-Reg/Reg: Phase-3 complete; Molecules filed but not yet commercial (Earlier labelled as ‘Development’) or where customer working towards adding Neuland as a second source for a commercial molecule • Commercial: Neuland generates revenues by manufacturing APIs for commercial novel molecules for innovators Q2 FY27 Pre-Clinical P-1 P-2 P-3 Pre-Reg/Reg Commercial Grand Total API 15 13 13 5 4 9 59 Intermediate 2 10 7 8 3 10 40 Grand Total 17 23 20 13 7 19 99 Q2 FY26 Pre-Clinical P-1 P-2 P-3 Pre-Reg/Reg Commercial Grand Total API 16 14 13 3 4 8 58 Intermediate 5 10 6 5 4 10 40 Grand Total 21 24 19 8 8 18 98 Q2 FY25 Pre-Clinical P-1 P-2 P-3 Pre-Reg/Reg Commercial Grand Total API 10 10 11 3 7 9 50 Intermediate 10 7 10 4 6 10 47 Grand Total 20 17 21 7 13 19 97 Q2 FY24 Pre-Clinical P-1 P-2 P-3 Pre-Reg/Reg Commercial Grand Total API 12 6 12 3 9 8 50 Intermediate 6 4 8 4 6 11 39 Grand Total 18 10 20 7 15 19 89 11 No. of active CMS projects CMS – Revenue Split & Number of Active Projects Rs. Cr 32 41 411 639 H1FY26 H1FY27 YoY Movement Development Commercial 19 23 43 20 32 291 247 488 418 214 Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 QoQ Movement Development Commercial Rs. Cr
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12 Company Overview
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13 Company Overview Established in 1984 40 years in API manufacturing and development Contract development and manufacturing of NCE API Manufacturing of generic non-exclusive APIs CDMO Services Generic APIs Business verticals Total reactor volume of 12,32,000 Liters ~2362 Employees, 479 in R&D Expertise in manufacture of Deuterated molecules, Cyanation, Solution and Solid phase peptides. Cyclic peptides and PEGylated peptides, Hydrogenation, Bromination, Chiral molecules manufacture, Cryogenic reactions, Enzymatic reactions, Synthetic portion of fermented molecules, Micronization (D90 <5 micron) Facilities Inspected by USFDA, EDQM, EMA, PMDA, Rx- 360, TGA, KFDA, ANVISA, WHO Supported 4 NDA filings and 27 IND filings by supplying APIs and CMC documentation Commercially Manufactured novel APIs and Intermediates for brands 3 cGMP Manufacturing facilities Chemical R&D Labs Peptide Labs Analytical R&D Labs Process Safety Labs Hydrogenation Lab
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40+ Years of experience 80+ Countries Served 1016+ DMFs Filed worldwide 77 Active US DMFs 100+ API across 10 diverse therapeutic areas 1232 KL API Manufacturing Capacity 92% Revenue from exports 2362 Employees 14 Key Facts
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15 Board Of Directors Dr. Davuluri Rama Mohan Rao Executive Chairman D. Sucheth Rao Executive Vice Chairman D. Saharsh Rao Chief Executive Officer & Managing Director Ms. Pallavi Joshi Bhakru Independent Director Mr. Prasad Raghavan Menon Independent Director Mr. Sugata Sircar Independent Director Mr. Homi Rustam Khusrokhan Independent Director Dr. Ravi Shankar Gopinath Independent Director Dr. Mauricio Futran Non-Executive Director
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16 Key Milestones Multiple audits passed with Zero observations Successfully cleared 18 USFDA inspections Our Journey Among India’s first 3 API facilities audited by CFDA – Unit I EDQM-audited API facility – Unit II Sole supplier of the first USFDA- approved deuterated molecule 2017 Crossed INR 10 bn revenue US FDA audit of Unit-III EDQM audit of Unit-I 2023 $100 M+ revenue over 75 live CMS projects US FDA audit of Unit-II 2020 Increased flow of projects from CMS Japan Active emphasis on supply chain de-risking 2019 Japan subsidiary2007 USA operation 2004 First US FDA audit 1997 Neuland goes public 1994 First API sale of Salbutamol Sulphate / Albuterol Sulphate 1986 Incorporated 1984 Unit – III Commercialization 320 kL reaction volume 2021 Acquisition of advanced intermediates & API facility (Unit III) 2018 R&D center established; EDQM audit of Unit-I 2008 PMDA Japan approval, First NCE approval 2009 Strategic alignment of business towards niche API & Custom Manufacturing Solutions 2013 R&D facility approved by US FDA 2016 Laying Strong Foundation 1984 - 2003 Deepening Our Capabilities 2004 - 2012 Increased Sustainable Growth 2013 - Today US FDA audit of Unit-I with Zero 483 2024 US FDA audit of Unit-II Capex investment of 511 crore 2025 2026 New Peptide Facility operational Planned Inauguration and Relocation to the new CMC Center for Process Research USFDA Audit of Unit-III
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17 Our Global Presence* 31% BD office in Princeton, New Jersey Since 2004 Manufacturing and Development partner to customers in over 80 Countries globally 1% LATAM 1% MENA 1% Headquarters in Hyderabad, India 3 Manufacturing Units INDIA 1% BD office in Tokyo, Japan Since 2007 JAPAN 63% EUROPE 2% APAC NORTH AMERICA * - Based on End-Market revenues – FY26
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18 Manufacturing Facilities Overview UNIT - I Bonthapally, Hyderabad 262 kL UNIT - II Pashamylaram, Hyderabad 389 kL UNIT - III Gaddapotharam, Hyderabad 581 kL 1986Year of Establishment 1994 2017 Block - 1, 2, 3, 4, H, kL & SBlocks Block-1, 2, 3, FC, NMSM, Mini plant(A&B) Block - 1, 2, 4, 5, 6, 7 & 8 7.5 kLHydrogenation Reaction Volume 6 kL 5 kL 100 kL/DSolvent Recovery System 20 kL/D 50 kL/D 25 kLCryogenic Reaction Volume 17 kL 15 kL USFDA, EDQM, CFDA, PMDA, Et al.Regulatory USFDA, EDQM, PMDA, ANVISA, Et al. Desktop Inspection by USFDA in 2020; USFDA May 2023, ANVISA (Brazil) 2022, USFDA August 2026 Peptide Module 1 – 6.3kL
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19 State-of-the-art R&D Centre Neuland’s R&D facility had been inspected by USFDA in February 2016 with zero observations Infrastructure • 15 Development Labs with space for expansion • 70 Fume hoods • Analytical Labs • Dedicated kilo Lab for Scale up • Dedicated Labs for Peptides • Approvals for DSIR, Govt. of India and USFDA • R&D Team of 479 People • 600 MHz NMR Significant R&D achievements • Several NCE APIs added in NDA or commercial stage drugs • Support for multiple APIs each year in Phase 2 and Phase 3 clinical candidates Generic API business • 1016+ DMFs filed • 300+ API processes developed • 204+ patents filed Neuland is set to open its new state-of-the-art research and development center, spanning across 140,000 square feet, in Hyderabad’s Genome Valley
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20 Regulatory Filings 77 DMFs with USFDA 33 Filings with Health Canada 10 Japanese DMF filed 17 China DMF filed 26 Filings with KFDA Korea 28 Filings with TGA 293 ROW filings including Turkey, Mexico, Brazil etc. ~500 EUDMF filings across Germany, France, Poland, Italy etc. 32 CEPs received for different products 1016+ Filings till date ** The numbers on this slide reflect the number of filings, the number of active filings could vary as geographic filings are merged and changes in product portfolio
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21 • FY26 revenues showed a significant increase due to the scale up in key molecules in the CMS business. The increase in revenues impacted other financial metrics as a result of operating leverage. • Revenue was impacted in FY2018 as a result of mismatch in capacity vs orders. EBITDA margins in FY19 & FY20 were impacted as a result of spike in RM prices, which led Neuland to actively work towards Supply chain de-risking before the COVID19 pandemic • ROCE was impacted due to acquisition of unit III in FY2018 which was commercialized in FY2021. Unit 3 utilisation levels have recently started ramping up and momentum is expected to continue FY2017 FY2018 FY2019 FY2020 FY2021 FY2022 FY2023 FY2024 FY2025 FY2026 Total Income 588.9 533.7 670.3 766.6 953.0 953.2 1,200.9 1,571.1 1,497.3 2,053.1 EBITDA 106.9 54.6 61.4 105.3 162.5 144.3 281.1 474.5 342.8 603.4 EBITDA Margin 18.1% 10.2% 9.2% 13.7% 17.1% 15.1% 23.4% 30.2% 22.9% 29.4% PAT 46.4 11.8 16.1 15.9 80.3 63.5 163.1 299.6 259.4 363.1 PAT Margin 7.9% 2.2% 2.4% 2.1% 8.4% 6.7% 13.6% 19.1% 17.3% 17.7% EPS 41.6 10.6 12.8 12.4 62.6 49.5 127.1 233.5 202.2 283.0 Current Ratio (x) 1.3 1.2 1.4 1.4 1.5 1.6 1.7 2.1 2.4 2.1 ROCE (%) 15.9% 5.0% 4.7% 8.9% 13.5% 9.7% 21.3% 32.8% 17.9% 26.1% Fixed Asset Turnover (x) 3.8 3.2 2.9 2.3 2.4 2.1 2.7 3.1 2.3 2.6 Debt to Equity (x) 0.7 0.5 0.3 0.3 0.1 0.2 0.1 0.1 0.1 0.1 Rs. Cr Financial Highlights FY2017-2026
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22 Business Strategy
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24 Our Businesses
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25 Generic APIs (GDS) 100 APIs across 10 diverse areas GDS • We are a preferred service provider in the manufacturing of Active Pharmaceutical Ingredients (APIs) • Have developed processes for over 100 APIs with a strong portfolio of complex molecules • Process Investigation Department (PID) majorly helps our customers to meet their price pressures by way of cutting their total cost of ownership in developing an API thereby achieving excellence in Process development • API manufacturing heritage of over 40 years • Flexible 100g to hundreds of tons capacity • Non-competitive advantage (does not compete in finished formulation) • Worldwide customer base in 80+ countries • Proven project management systems • Impeccable EHS record Three US FDA and cGMP compliant manufacturing facilities Total capacity of the reactor volume 12,32,000 liters Facilities & Capacity 100 APIs across 10 diverse areas
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26 CDMO Services (CMS) Three US FDA and cGMP compliant manufacturing facilities Total capacity of the reactor volume 12,32,000 liters Facilities & Capacity cGMP manufacturing of RSMs/KSMs/Intermediates and APIs for clinical trials and commercial supply IND/NDA filing support Process optimization Designing and developing manufacturing processes Solid state & pre- formulation technologies CMS Services Chemistry & manufacturing capabilities Synthetic portion of fermented molecules Deuterated molecules Peptides in solid, solution phase & hybrid technology Steroidal bile acids & vitamin D derivatives Cyanation, hydrogenation, bromination, cryogenic Carbohydrate chemistry Cyclic and PEGylated peptides Organometallic carbon- carbon bond formation Chiral compounds manufacturing Heterocyclic compounds
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27 Shareholder Information
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28 Promoters 32% DII 16% FII 22% Others 30% Shareholding Details Share Information (as on 30th September 2026) NSE Ticker NEULANDLAB BSE Ticker 524558 Market Cap (Rs. In Cr) 27,446.53 % free float 67.74 Free Float Market Cap (Rs. In Cr) 18,592.28 Shares Outstanding 12,829,889 3M Average Daily Traded Volume (ADTV) (Shares) 63,317 3M Average Daily Traded Value (ADTV) 137.31 Industry Pharmaceuticals * Source: BSE & NSE
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29 Annexure
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30 Profit & Loss Snapshot (Standalone) Particulars (Rs Cr) Q2 FY 27 Q2 FY 26 YoY% Q1 FY 27 QoQ% H1 FY 27 H1 FY 26 YoY% Total Income 457.15 516.07 -11.4% 650.07 -29.7% 1,107.22 816.68 35.6% EBITDA 104.55 156.92 -33.4% 231.07 -54.8% 335.62 199.07 68.6% EBITDA Margin 22.9% 30.4% -754 BPS 35.5% -1267 BPS 30.3% 24.4% 594 BPS Profit Before Tax 68.48 129.04 -46.9% 197.54 -65.3% 266.02 146.42 81.7% PBT Margin 15.0% 25.0% -1002 BPS 30.4% -1541 BPS 24.0% 17.9% 610 BPS Profit After Tax 51.13 96.46 -47.0% 147.36 -65.3% 198.49 110.17 80.2% PAT Margin 11.2% 18.7% -751 BPS 22.7% -1148 BPS 17.9% 13.5% 444 BPS EPS (Rs.) 39.85 75.18 -47.0% 114.86 -65.3% 154.71 85.87 80.2%
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31 Revenue & PBT trend Rs Cr * Q1FY25 and Q3FY25 includes exceptional item of profit on investment property of Rs. 20.6 crores and Rs. 55.8 crores respectively 294 270 415 365 421 395 390 444 315 402 336 301 516 448 789 650 457 Q2FY23 Q3FY23 Q4FY23 Q1FY24 Q2FY24 Q3FY24 Q4FY24 Q1FY25 Q2FY25 Q3FY25 Q4FY25 Q1FY26 Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 Revenue 53 39 110 84 121 104 92 130 49 128 39 17 129 54 287 198 68 Q2FY23 Q3FY23 Q4FY23 Q1FY24 Q2FY24 Q3FY24 Q4FY24 Q1FY25 Q2FY25 Q3FY25 Q4FY25 Q1FY26 Q2FY26 Q3FY26 Q4FY26 Q1FY27 Q2FY27 PBT* Rs Cr
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33 Sustainability Framework: ESG commitment & Goals (1/3) Environment Focus area Our commitments Key ESG goals (included in Balance Scorecard) Emissions and climate change • Reduce both direct (Scope 1 & 2) and indirect (Scope 3) emissions. • Adopt cleaner technologies and improve energy efficiency. • FY 2033-34: 58.8%* reduction in Scope 1 & 2 emissions (FY 2023-24 baseline) • FY 2049-50: Achieve Net Zero in absolute emissions (subject to residual ~10%) • FY 2033-34: 63.8% *GHG emission reductions in indirect Scope 3 emissions (FY 2023-24 baseline) • FY 2049-50: Achieve net-zero emissions across operations and value chain (subject to residual ~10%) Water management • Improve water use efficiency and move toward water neutrality. • FY 2034-35: Achieve 25% water neutrality • FY 2049-50: Achieve 100% water neutrality Effluent and waste • Maintain Zero Liquid Discharge (ZLD) status for our manufacturing operations, reduce solid waste, and ensure 100% co-processing • Maintain Zero Waste to Landfill • 100% co-processing of hazardous waste • Maintain ZLD status of effluents R&D and innovation • Drive sustainable R&D and technology innovation to reduce environmental impact. • Adoption of Green Chemistry and aim to achieve Zero solvent carbon footprint
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34 Sustainability Framework: ESG commitment & Goals (2/3) Focus area Our commitments Key ESG goals (included in Balance Scorecard) Occupational health and Safety • Strive for zero harm environment across all operations • Maintain Zero Fatality • Maintain Nil Long-term Injury • Frequency Rate (LTIFR) Diversity and Inclusion • Promote equal opportunity and build a more inclusive workplace • Promote well being and a safe place to work • FY 2029-30: 10% women in management • FY 2029-30: 16% of all hirings will be women Community well-being • Support health, education, and livelihood initiatives for underserved communities. • Ensure Planned social impact investments on well-being of neighboring communities is maintained, while expanding the reach of CSR to larger population Social
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35 Sustainability Framework: ESG commitment & Goals (3/3) Governance Focus area Our commitments Key ESG goals (included in Balance Scorecard) Product Quality and Regulatory compliance • Strong Quality Culture • Maintain 100% compliance across GMP operations Business Continuity & Risk Management • Build resilience through enterprise-wide risk management, crisis readiness, and business continuity plans • Strengthen crisis management and business continuity capability Digitalisation • Leverage digital tools for transparency, efficiency, and data driven decision-making • >90% of business process digitised across key functions by FY29-30 Sustainable Supply Chain • Build a responsible and transparent supply chain that supports sustainability goals • Sustainable Supply Chain roadmap with clearly-defined milestones
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36 Term Description Active Pharmaceutical Ingredient (API) Any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body Biologic Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Commercial molecules Molecules where Neuland is manufacturing for commercial use after the product has been approved Custom Manufacturing Solutions (CMS)/ Contract Development and Manufacturing Organization (CDMO) Develop and manufacture pharmaceutical ingredients and intermediates in line with customer expectations. Development Molecules Projects where Phase-3 is over, and molecules have been filed but not yet commercial. DMF A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs GDS Generic Drug Substance (GDS) segment which includes Prime products and Specialty products International Council for Harmonisation (ICH) Guidelines Harmonisation project involving regulatory authorities and pharmaceutical industry to improve efficiency of new drug development and registration processes New Chemical Entity (NCE) NCE is granted to “a drug that contains no active moiety that has been approved by FDA in any other application” Peptides Peptides are sequences of molecules called amino acids. Peptides of precise sequences may occur naturally in the body, but they may also be produced synthetically or using recombinant DNA technology in bacteria and other living systems. These molecules are used to treat a variety of diseases Term Description Pipeline drugs Drugs (small or large molecule) under development by a manufacturer Prime APIs The prime products which typically include mature APIs with relatively higher competition in API space have historically contributed more than 70% of the total business. Specialty/ Niche APIs Molecules in the API space which are complex in nature and are in the nature of ‘high value’ added products and Neuland’s focus has been to develop these molecules from laboratory scale to large commercial quantities Preclinical study Preclinical studies take place in animals before any testing in humans is done. Phase I clinical trial Researchers test an experimental drug or treatment in a small group of people for the first time. Phase II clinical trial The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III clinical trial The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. Small molecule products A drug that can enter cells easily because it has a low molecular weight. Once inside the cells, it can affect other molecules, such as proteins, and may cause cancer cells to die. This is different from drugs that have a large molecular weight, which keeps them from getting inside cells easily. Many targeted therapies are small-molecule drugs USFDA The US Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices Source: FDA.gov, Neuland Glossary
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Thank you For further information contact IR Desk Neuland Labs Contact: +91 40 6761 1600 Email: ir@Neulandlabs.com Runjhun Jain / Minakshi Machutre EY IR Contact: +91 22 6192 2000 Email: Runjhun.Jain1@in.ey.com / Minakshi.Machutre@in.ey.com