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Sai Life Sciences Limited Investor Presentation November 07, 2025
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Safe Harbour 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. 2
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The CRDMO industry is a Service Business with value drivers different from generic pharma companies As a CRDMO, our value doesn’t hinge on drug approvals - we’re not in the business of binary outcomes. We generate consistent, scalable value through scientific depth, execution reliability, and long term client partnerships. - Krishna Kanumuri, MD & CEO • R&D investments in drug discovery / development program translate to revenue opportunities for CRDMOs – irrespective of whether it receives approval or not • Stage-gating decisions rest with the innovator (clients) • Given the multitude of factors involved, the success or failure of a molecule is never directly attributed to the CRDMO. • CRDMOs are purely judged by the quality of work they render within the scope of the defined project “ “ 3
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Executive Summary
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5 Message from Managing Director & CEO Mr. Krishna Kanumuri MD & CEO We are pleased to report another strong quarter, supported by healthy demand across our discovery, development, and manufacturing services. The performance was driven by consistent execution, growing client relationships, and continued traction in late-stage and commercial programs. As the industry evolves toward more complex and diversified science, we continue to invest in new modalities, advanced technologies, and capacity expansion to strengthen our long-term competitiveness. These investments are enabling us to address a broader range of client needs, enhance efficiency across the value chain, and build deeper scientific capabilities for the future. Looking ahead, our priorities remain centered on scaling responsibly, advancing technology-led innovation, and deepening client collaborations. With a strong foundation, expanding infrastructure, and scientific excellence at the core of our strategy, Sai Life Sciences is well positioned to deliver sustainable growth and long-term value. “ “
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6 Message from Whole-time Director and Chief Financial Officer Mr. Siva Chittor Whole-time Director & CFO We sustained our positive momentum this quarter, maintaining growth across our business and keeping Sai Life Sciences firmly on track toward its long-term aspirations. Total revenue for Q2FY26 stood at ₹537 Cr, up 36% year-on-year, driven by healthy performance across both the CRO and CDMO services. EBITDA for the quarter was ₹156 Cr, with margins at 29%, supported by improved operating leverage, better utilization and continued cost discipline. We incurred capex of ₹248 Cr during H1, primarily directed toward expanding our R&D capacity, and advancing our offerings in new modalities and technologies. These investments are aligned with our strategy to enhance scientific depth and build scalable capacity to support future growth. We remain focused on maintaining financial discipline, driving margin improvement, and deploying capital effectively to sustain long-term, profitable growth. “ “
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Business Highlights 7 Deepening Capabilities In New Technologies and Modalities • “Following-the-molecule” in peptides, the company is complementing existing discovery capability with development and scale-up capability. • Successfully completed photo-flow chemistry scale-up at plant scale for a large pharma client • Working on a large pharma collaboration on ADC chemistry & have completed bioconjugation at the discovery stage for a large pharma client; building OEB-6 labs for Discovery and CMC to strengthen ADC capabilities. • Validating a phosphoramidite process for a commercial oligonucleotide molecule Quality and Compliance Excellence • Successfully completed 35 customer and 3 regulatory audits across manufacturing and R&D units in the past 12 months, with zero data integrity deviations and zero critical observations Building R&D Capacity • Completed phase 2 expansion of Vivarium, Hyderabad R&D Centre - added 12,000 sq. ft. (total 27,000 sq. ft.) with expanded preclinical and assay capabilities Integrated CMC Partnership • Partnered with Agility Life Sciences (UK) and Centrix Pharma (UK) to provide end-to-end CMC services from API development to drug product manufacturing and first-in-human trials Sustainability & Inclusion Commitments • Near-term GHG reduction targets were validated by SBTi reinforcing climate-aligned growth • Signed UN Women’s Empowerment Principles (WEPs) - strengthens focus on gender equality and inclusive workplace practices
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Consolidated Financial Highlights (Quarterly) 8 Revenue (₹ Cr) Material Margin (₹ Cr) and Margin (%) 396 537 Q2FY25 Q2FY26 291 397 73.7% 73.9% Q2FY25 Q2FY26 EBITDA (₹ Cr) and Margin (%) PAT (₹ Cr) and Margin (%) 109 156 27.5% 29.0% Q2FY25 Q2FY26 Q2FY26 Revenue Contribution 66% 34% • Revenue for Q2FY26 was ₹537 crore, a 36% increase over ₹396 crore in Q2FY25, driven by strong growth both in CRO and CDMO services • CDMO recorded revenues of ₹352 Cr in Q2FY26, up 37% from ₹240 Cr in Q2FY25 • CRO recorded revenues of ₹185 Cr in Q2FY26, up 19% from ₹156 Cr in Q2FY25 • EBITDA for Q2FY26 stood at ₹156 Cr compared to ₹109 Cr in Q2FY25, an increase of 43% • EBITDA margin improved by 150 bps to 29% in Q2FY26 • PAT for Q2FY26 stood at ₹84 crore. CDMO CRO 42 84 10.5% 15.6% Q2FY25 Q2FY26 36% YoY 36% YoY 43% YoY 102% YoY
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Consolidated Financial Highlights (Half Yearly) 9 Revenue (₹ Cr) Material Margin (₹ Cr) and Margin (%) 675 1,034 H1FY25 H1FY26 498 753 73.8% 72.8% H1FY25 H1FY26 EBITDA (₹ Cr) and Margin (%) PAT (₹ Cr) and Margin (%) 28 144 4.1% 14.0% H1FY25 H1FY26 140 28120.7% 27.2% H1FY25 H1FY26 H1FY26 Revenue Contribution 64% 36% • Revenue for H1FY26 was ₹1,034 crore, a 53% increase over ₹675 crore in H1FY25 • CDMO recorded revenues of ₹667 Cr in H1FY26, up 72% from ₹387 Cr in H1FY25 • CRO recorded revenues of ₹367 Cr in H1FY26, up 28% from ₹288 Cr in H1FY25 • EBITDA for H1FY26 stood at ₹281 Cr compared to ₹140 Cr in H1FY25, an increase of 101% • EBITDA margin expanded by 652 bps YoY to 27.2% in H1FY26 • PAT for H1FY26 stood at ₹144 crore. • Invested ₹248 crore in capital expenditure, against a plan of ₹700 Cr for FY26 CDMO CRO 53% YoY 51% YoY 101% YoY 415% YoY
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Sustained Growth Momentum with Expanding Profitability 870 1,217 1,465 1,695 15% 15% 20% 25% FY22 FY23 FY24 FY25 IPO Positioned to achieve 15-20% revenue CAGR over 3-5 years & 28 - 30% EBITDA margins in the next 2-3 years Delivered consistent revenue growth and expanding profitability, with EBITDA margins rising from 15% in FY22 to 25% by FY25 and maintaining positive momentum in H1FY26, keeping Sai on track towards its longer-term growth aspirations 675 1,034 21% 27% H1FY25 H1FY26 Revenue (₹ Cr) EBITDA Margin (%) (Consolidated) 10
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Company Overview
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Sai Life Sciences: At a Glance 25+ Years of Expertise Founded in 1999, Sai Life Sciences has transformed into an integrated CRDMO, delivering value across the pharma lifecycle from early discovery to commercial manufacturing Global Partner of Choice Trusted by 300+ global clients, including 18 of the top 25 global pharma companies across the US, UK, EU, and Japan Expansive Infrastructure World-class R&D and manufacturing facilities across Hyderabad, Bidar, Manchester, and Boston, with ~700 KL of installed capacity Innovation-Led Growth Focused investments in next- gen modalities like Peptides, ADCs, Oligos and TPDs; empowered by digital transformation, automation, and AI/ML to accelerate delivery and differentiation 12
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Key Highlights 3,400+ Total employees USFDA, PMDA 100% successful track record of regulatory inspections across our R&D and manufacturing facilities. 300+ Active customers across US, UK, EU, Japan Diverse therapy areas Oncology, CNS, Inflammation, Antivirals, Rare diseases and more 10+ Years: Enduring customer relationships 18/25 of the largest pharmaceutical companies are customers 30 Commercial molecules >65% Integrated Drug Discovery Services 18 months Demonstrated time from Hit to IND 25+ Years of experience (Incorporated in 1999) One-stop platform for discovery, development and manufacturing 40+ Programs advanced to IND or Phase I/II/III 5 Molecules from discovery to market 6 Phase III/ pre-registration 13
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Global Presence 14 Strategically located to combine innovation access, client proximity, and cost efficiency Research laboratories for discovery and development located near overseas innovation hubs in Greater Boston, US and Manchester, UK, complemented by large-scale research laboratories and manufacturing facilities in cost competitive locations in India Sai Facilities Presence Exploratory Biology Lab in the Cambridge-Boston Life Sciences ecosystem Boston Manchester Process R&D Lab in Alderley Park Bidar Hyderabad 700 KL GMP Manufacturing 13-acre Integrated R&D Campus in Genome Valley Global Delivery Model
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Our Growth Journey • Incorporated in 1999; began as a medicinal chemistry partner to US biotech firms • Expanded into Process R&D and small-scale manufacturing aligned with the needs of Biotechs clients • First USFDA approval of Unit IV • Expanded R&D (Unit II) to enable large-scale pharma CDMO services • Added 100 KL capacity at Unit IV • Animal facility received AAALAC accreditation • Cleared USFDA & PMDA audits at multiple sites • Integrated Biology services; becoming end-to-end Discovery partner • Added >120 KL (PB-07) and >170 KL (PB-08) blocks at Unit IV • Entered global markets: labs in Manchester & Boston • Commissioned Clean Room, Amidites, and HPAPI blocks at Unit IV • Strategic partnership with Schrödinger to enhance discovery science • Continued regulatory track record and expansion of global footprint • Listed on NSE & BSE • Construction underway for new MedChem block with 200 fume hood capacity • Broke ground for a new Process R&D Block at Unit 2 Hyderabad, nearly doubling PRD capacity and adding capabilities in early phase peptide development and clinical formulations • Commenced work on building additional 200kL production capacity at Unit IV, Bidar 1999 - 2008 2009 – 2013 2014 – 2018 2019 – 2023 2024 – Present Founding & Early Biotech Foray CDMO Pivot CDMO Consolidation, Biology Foray Globalization, Scaled-up Integrated CRDMO Increasing Capacity & Strengthening New-Age Modalities 15
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A leading CRDMO with scaled operations across both verticals 16 Sai Life Sciences operates as both a CRO and a CDMO, offering an end-to-end platform for global pharmaceutical and biotech companies • Medicinal Chemistry & Computational Drug Discovery • Biology & Pharmacology Research • DMPK & Toxicology Studies • Preclinical Research & IND Filing • Process Development & Optimization • Analytical Development & Validation • Formulation Development & Stability Studies • Clinical Trial Supplies (Phase I-III) • Regulatory Compliance & Quality Assurance • API (Active Pharmaceutical Ingredient) Manufacturing • Technology Transfer & Scale-Up • Commercial Production & Global Supply Chain • Regulatory-Compliant Manufacturing (US FDA, PMDA, COFEPRIS) Phase 1 DISCOVERY (CRO) Phase 2 DEVELOPMENT (CRO & CDMO) Phase 3 MANUFACTURING (CDMO) Seamless Integration – One-stop solution from research to commercial production Regulatory Excellence – Compliant with global standards (US FDA, PMDA, COFEPRIS) Scalable & Flexible – Supporting emerging biotech & leading pharma companies
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Discovery Services (CRO) 17 Notes: (1) Last 5 years (2) Discovery services (including chemistry, biology and/or DMPK services) Consistent Revenue Growth (₹ Cr) 189 274 467 497 626 FY21 FY22 FY23 FY24 FY25 Client Stickiness >65% Revenues from customers in FY23-25 who availed more than one Discovery services(2) Dedicated Facility Among the few CROs with a dedicated facility for a global innovator, now scaled up by 30% to support growing demand and deeper integration. Modalities Expansion Expanding capabilities in ADCs, TPDs, Peptides, CGTs, Oligos, and more. 33% 38% 67% 62% FY24 FY25 Pharma Biotech Customer Split %
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Discovery Services: Scaling Innovation, Driving Impact 18 >65% of Discovery programs are now integrated, with active use of next-gen biology, automation, and AI to accelerate development and improve outcomes Technology advancements are transforming Sai’s Discovery platform into a scalable, high-value growth engine Expanded Core Capabilities Scaled Chemistry, Biology, DMPK, and In Vivo labs delivering faster, parallelized research Colocalized & Global Teams Hyderabad campus and Boston Biology Lab enable seamless collaboration and rapid tech transfer Tech-Enabled Drug Discovery AI-enabled retrosynthesis tools High-throughput Experimentation DMPK automation CADD in silico tools Specialized Modalities Peptides, ADC payloads, Oligos, TPDs and driving high-value Discovery growth Next-Gen Preclinical Models Organoids and spheroids enable predictive, FDA- aligned efficacy and toxicity testing
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CMC Services (CDMO) • End-to-End capabilities from IND through to commercialization • Focus on Complex Chemistry, ADC Payloads & Linkers • Modern, GMP-compliant facilities across UK and India • Flexibility to support both small-scale clinical supplies and large-scale commercial production. • Proven track record of commercializing NCEs • Robust regulatory record with USFDA and PMDA • 160 Programs in the pipeline across multiple therapy areas • Clear Regulatory Record: USFDA, PMDA • At the forefront of digitalization, automation and sustainability Business Mix Revenue Contribution – By Therapy (%) 571 596 760 968 1,068 FY21 FY22 FY23 FY24 FY25 Note: Therapy area contribution varies year-to-year based on client portfolio mix and project timelines. Not indicative of overall market trends Consistent Revenue Growth (₹ Cr) 11% 11% 8% 14% 22% 7% 3% 4% 4% 17% 21% 18% 12% 10% 10% 9% 4% 3% 3% 10% CNS Infectious Diseases Cardiovascular Anti Histamine Oncology Metabolic Disorders Genetic Disorders Dermatology Immunology Others FY24 FY25 79% 91% 21% 9% FY24 FY25 Pharma Biotech Customer Split % 19
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New Modalities: Fortifying foundation to build scale 20 4% 3% 3% 7% FY22 FY23 FY24 FY25 New Modalities Revenue Contribution (%) Peptides Complement peptide discovery with process and scale-up facilities for clinical supplies; focus on commercial supply of fragments before evolving to full-scale peptide manufacturing. Antibody-Drug Conjugates Enhancing conjugation in Discovery; upgrading to class 6 containment for end-to-end support. Evaluating clinical conjugation and fill-finish for clinical supply Oligonucleotides Involved in multiple projects with Pharma from development to commercial; to focus only on making amidites. Lipids Involved in supplying lipids for last few years; looking to expand capacity
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Our Strengths
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Strategic Growth Levers & Competitive Edge Deeper Customer Engagement Expanding Capacity & Capabilities Global Footprint, Local Advantage Quality & Sustainability Leadership Technology-Driven Efficiency Talent & Innovation Culture 22
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Information Technology - Driven Excellence: Digitization & Beyond Digitization 2017 onwards Digitalization 2022 onwards Digital Transformation 2023 onwards Converting data, documents and processes from paper/ analog to digital integration of digital technologies into all aspects of business operations Use of digitized data for effective monitoring through visual interactive dashboards. • GMP Pro and ELN implementation • QR Code & Label Management • Learning Management System • Audit Management System • Laboratory Information Management System • Validation Life Cycle Management System • Batch Quality, Yield, Experiments, Equipment Occupancy, Staffing status, QMS, etc. • Digital Transformation Initiatives • AI/ML - Manufacturing Process Prediction Model R&D and Mfg processes progressively digitized to current levels of 85% digitization Interactive Business Intelligence dashboards created using real-time data across functions and use cases. Leveraging large data sets with AIML models to create prediction models. Looking Ahead • Digitization process expected to be complete by 2027 • Continued adoption of BI models to aid faster decision-making • AI/ML model proof-of-concept outcome to emerge in 2026. • Based on results, further integration into operations will be undertaken. 23
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Global-Standard Operations, End-to-End Quality Assurance • 285+ QA/QC professionals across sites • Integrated e-systems: LIMS, e- QMS • QA independent; reports to CEO • Audited by USFDA, EMA, PMDA, Indian regulators • Focus on data integrity & global compliance Sustainability Leadership • 89% renewable energy at Bidar site • Zero Liquid Discharge: water- neutral ops • Carbon roadmap approved by SBTi • Low-emission logistics via DHL Safety & EHS Leadership • Embedded Process Safety from quote to execution phase; rigorous lifecycle safety assessments. • Plant Intermediates areas & lab fume cupboards validated down to 1 µcg/ m3 containment • First Indian company to join the PSCI membership; >30 PSCI Audits over the past 7 years • Silver rating by EcoVadis 24
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Key Drivers for Growth Scaling Capacity & Infrastructure • The company continue to make strategic capital investments in line with its annual capex plan of ~ ₹700 Cr for FY26 to enhance manufacturing and R&D infrastructure, including development of a second manufacturing site in Hyderabad. • These strategic investments will nearly double Sai’s overall manufacturing capacity by FY27, while diversifying its footprint and reducing concentration risk Diversifying Portfolio • 36 active molecules* –30 commercial, with 6 Phase III / pre registration • 160 in early phase development • Established model for a dedicated partnerships • Average tenure of large pharma relationships is ~10 years • 200+ clients, 60+ integrated collaboration under discovery Scientific & Talent Leadership • Driving global program transfers to India across discovery, development & manufacturing • Rapidly expanding leadership bench with experts from top CDMOs and global pharma • Strengthening capabilities in new modalities, enabling pipeline expansion and stickier client relationships • Building future-ready teams aligned to Sai’s scale-up and innovation roadmap * Excluding molecules under destocking and low value molecules with limited potential 25
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Expansion Plans
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Capacity Expansion Underway: Scaling from 700 KL to 1,150 KL by 2026 27 16 40 105 230 450 475 700 1,150 0 200 400 600 800 1,000 1,200 1,400 2009 2011 2013 2017 2021 2023 2025 2026 Reactor capacity in KL Unit 3 & Unit 4 Blocks 1-6 PB07 Intermediate Block PB08 Intermediate PB09 clean room blocks PB 10 high potency & PB 12 amidite blocks PB 11 Intermediate block & unit 06 animal health API block PB 14 & 15 Intermediate Block in 5.9 Acre U4 ext
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CMC Process R&D Block 28 Sai Life Sciences has commenced construction of a new CMC Process R&D Center at its Hyderabad campus, targeted for completion by September 2026. The facility will double Process R&D capacity. Designed to support both FTE and DPC engagement models, it will offer flexible collaboration for global innovators across early to late-stage CMC programs. ▪ Specialized labs for peptides and Amidites ▪ Kilo Lab for early clinical supplies ▪ NCE Formulation Development & Early Phase Clinical Supplies ▪ Designed to meet OEL 4 (1 µg/m3) band ▪ Process R&D lab and Scale up Lab ▪ ~140 process chemistry fume hoods with satellite analytical lab ▪ Buildup area ~100K Sq.Ft across 5 floors with Green building Certification ▪ 25,000 sft of Analytical Lab under a single roof Note: FTE- Full Time Equivalent. DPC- Discovery Process Chemistry
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Industry Overview
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Global CRDMO Industry Set to Cross USD 300 Bn by 2028 30 Global CRDMO Market (USD Bn) 127 196 303 2018 2023 2028E Global CRDMO Market by Modality (USD Bn) 106 153 22521 44 77 2018 2023 2028E Large molecule Small molecule • Global CRDMO market projected to reach USD 303 Bn by 2028 (9% CAGR 2023-2028) • 50%+ of pharma R&D budgets outsourced to CRDMOs, driving structural growth • Biologics, peptides, and oligonucleotides expected to drive ~40% of total growth by 2028 • Large molecule CRDMO segment growing fastest (12% CAGR 2023 - 28), supported by biologics demand • Asia-Pacific market projected to grow at 12% CAGR (2023–28) - the fastest among all regions, outpacing Europe (10%) and North America (5%) With growing investments in Peptides, Oligos & ADCs, Sai Life Sciences is positioned to capture growth in the fastest- expanding CRDMO segments globally Source: Frost & Sullivan
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India Rising as a Strategic CRDMO Hub 31 Indian CRDMO Market (USD Bn) 4 7 14 2018 2023 2028E Global CRDMO Market by Modality (USD Bn) 4 7 13 0 1 1 2018 2023 2028E Large molecule Small molecule • Indian CRDMO industry is among the fastest-growing worldwide, projected to grow at 14% CAGR (2023–28) • By 2028, CDMO is expected to contribute ~75% of India’s USD 14 Bn CRDMO market, growing to USD 11 Bn, while CRO expands to USD 3 Bn • Cost efficiency (30–40%) with global-standard quality is making India the preferred outsourcing destination for pharma sponsors Sai Life Sciences is scaling capacity, innovation, and specialty modalities to leverage India’s rising global CRDMO share and China- to-India outsourcing shift. Source: Frost & Sullivan
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Annexure
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Consolidated Statement of Profit and Loss 33 Particulars (₹ Cr) Q2FY26 Q1FY26 Q2FY25 H1FY26 H1FY25 FY25 Revenue from operations 537 496 396 1,034 675 1695 Other income 5 6 4 11 7 18 Total income 543 502 399 1045 682 1712 Expenses Cost of materials consumed and changes in inventories 140 141 104 281 177 466 Employee benefits expense 163 161 135 323 265 549 Other expenses 89 74 55 162 105 274 Forex (gain)/loss (10) (4) (6) (14) (11) (19) EBITDA 156 125 109 281 140 425 EBITDA Margin 29% 25% 27% 27% 21% 25% Finance costs 9 12 21 22 42 76 Depreciation and amortisation expense 40 38 36 77 67 139 Profit before tax 112 81 55 193 37 228 Tax expense 28 20 14 49 9 58 Profit after tax 84 60 42 144 28 170
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Consolidated Balance Sheet 34 Assets (₹ Cr) Mar 25 Sept 25 Non Current Assets Property, Plant, and Equipment 1,185 1,337 Right of Use of Assets 292 276 Capital Work in Progress 124 115 Intangible Assets 11 9 Financial assets - Investments 2 2 - Other Financial Assets 5 25 Deferred Tax Assets 14 14 Non Current Tax Assets (Net) 8 2 Other Non-current Assets 13 61 Total Non-current Assets 1,655 1,842 Current Assets Inventories 119 122 Financial Assets - Trade Receivables 355 492 - Cash and Bank Balances 464 306 - Other Financial Assets 80 60 Other Current Assets 487 509 Total Current Assets 1,505 1,489 TOTAL Assets 3,160 3,331 Equity and Liabilities (₹ Cr) Mar 25 Sept 25 Equity Equity Share Capital 21 21 Reserves and Surplus 2,108 2,249 Total Equity 2,128 2,270 Non Current Liabilities Financial Liabilities - Lease Liabilities 165 `146 Provisions 23 30 Deferred Tax Liabilities (Net) 111 110 Total Non-current Liabilities 299 286 Current Liabilities Financial Liabilities - Borrowings 129 215 - Lease Liabilities 59 56 - Trade Payables 323 245 - Other Current Financial Liabilities 75 90 Other Current Liabilities 128 133 Provisions 11 19 Current Tax Liabilities (Net) 8 17 Total Current Liabilities 732 775 TOTAL Equity and Liabilities 3,160 3,331
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Awards Certificates & Accreditations 35 ISO 14001:2015, ISO 45001:2018 & ISO 50001:2018 certification Certificate of Registration: Information Security Management System – ISO/IEC 27001:2013 Affiliations with Leading Industry organizations: Signatory of United Nations Global Compact (UNGC) Eco Vadis Silver Medal for Sustainability CII-SR EHS Excellence Award for 5 Years GSK’s Environmental Sustainability Supplier award 2021 in ‘Primary Manufacturing’ category
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Glossary 36 APIs Active pharmaceutical ingredients Biotechs Biotechnology companies, often referred to as biotech companies, are largely startups in the pharmaceutical sector which typically focus on developing innovative drugs and drug development technologies to address unmet medical needs Blockbuster End Molecules Blockbusters are drug products with annual sales of over US$1 billion in the Financial Year 2023 CDSCO Central Drug Standards Control Organization, India CMC / CDMO Chemistry, Manufacturing and Control / Contract Development and Manufacturing Organization CMO Contract Manufacturing Organization COFEPRIS Mexico Federal Commission for the Protection against Sanitary Risk of Mexico CRDMO Contract Research, Development, And Manufacturing Organization CRO Contract Research Organization DMPK Drug metabolism and pharmacokinetics GATT General Agreement on Tariffs and Trade Generic drugs Refer to pharmaceutical drugs that have the same chemical composition as the original innovator drug and can be sold by companies after the patent on the original drug expires Innovation Clusters/Hubs Nine regions identified by Frost and Sullivan including Boston/Cambridge in Massachusetts, Manchester/London/Cambridge in UK, Chicago in Illinois, New Jersey, New York, Paris in France, Switzerland and Japan. In 2022, approximately 57% of global R&D spending were in these nine pharma hubs Innovator Drugs Refer to first drugs created containing specific active ingredients and undergo approval or patent process for use Large Molecule Have a large molecular weight and made of proteins that are complex in structure compared to small molecule drugs. Costly to manufacture and, at this time, in most cases can only be administered by injection or infusion. Typically manufactured biologically, i.e. extracted from living organisms, but often include certain synthetic chemistry processes Large Pharma Companies Pharma companies with revenues > USD 10 billion Mid Pharma Companies Pharma companies with revenues in range of USD 500 million to USD 10 billion NCE New chemical entities PMDA Pharmaceuticals and Medical Devices Agency, Japan Small Molecule Organic compound with low molecular weight, small molecule drugs are known for their affordability, ease of administration (largely orally), and broad therapeutic coverage. Typically manufactured using synthetic chemistry processes Small Pharma Companies Pharma companies with revenues lower than USD 500 million TRIPS Trade-Related Aspects of Intellectual Property Rights UNIT IV Manufacturing facility at Bidar USFDA United States Food and Drug Administration
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© Sai Life Sciences Limited. L4, SLN Terminus, Gachibowli, Hyderabad 500032, Telangana, India. For more details please contact: Investorrelation@sailife.com Thank You