Gland B2B Business Model and Growth Strategy

Made public by

sourced by PitchSend

5 of 39

Category

Healthcare

Published

March 31, 2021

Slides

Transcriptions

#1GLAND GLAND PHARMA LIMITED Gland Pharma Limited Financial Results Q4'FY21 & FY21 17th May 2021 Gemcitabl Injection Gemcitabi Injection Gemcitab Injection#2Safe Harbor Statement 2 The Presentation is to provide the general background information about the Company's activities as at the date of the Presentation. The information contained herein is for general information purposes only and based on estimates and should not be considered as a recommendation that any investor should subscribe / purchase the company shares. This presentation may include certain "forward looking statements". These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India and any other country, ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global pharmaceuticals industries, increasing competition, changes in political conditions in India or any other country and changes in the foreign exchange control regulations in India. Neither the company, nor its directors and any of the affiliates or employee have any obligation to update or otherwise revise any forward-looking statements. The readers may use their own judgment and are advised to make their own calculations before deciding on any matter based on the information given herein. No part of this presentation may be reproduced, quoted or circulated without prior written approval from Gland Pharma Limited. GLAND#33 Financial Highlights (1/3) Sustainable growth with optimal investments for the future Revenue from Operations (INR Mn) 40% 8,877 6,352 26,332 32% 34,629 EBITDA (1) / EBITDA Margin (2) (INR Mn / %) 31% 3,749 2,861 31% 14,370 10,946 42% 40% 39% 40% Q4 FY20 Q4 FY21 FY20 FY21 Q4 FY20 Q4 FY21 FY20 FY21 PBT/PAT / PAT Margin (3) (INR Mn / %) 2,615 1,948 29% 34% 3,489 2,604 9,929 7,729 28% 28% Q4 FY20 Q4 FY21 FY20 Profit Before Tax Profit After Tax R&D Expenses / R&D (% of Revenue) (INR Mn / %) 29% 13,348 9,970 75% 32% 1,220 304 922 173 28% 2.7% 3.4% 3.5% 3.5% FY21 Q4 FY20 Q4 FY21 FY20 Note: (1) EBITDA stands for earnings before interest, taxes, depreciation and amortisation which has been arrived at by adding finance expense, depreciation expense and total tax expense to the profit for the year. (2) EBITDA margin = EBITDA / Total Income; (3) PAT margin = Profit for the year / Total Income FY21 GLAND#4Financial Highlights (2/3) Balance sheet strength to support future growth Net Worth (1) (INR Mn) 59,032 Cash and Bank Balances / Net Cash (2) (INR Mn) 12,250 36,462 46,782 13,252 13,202 Mar'20 Mar'21 ■Networth ■Fresh issue of equity Net Working Capital (3) (INR Mn) 11,621 Mar'20 30,058 30,017 Mar'20 Mar'21 ■Total Cash ■Net Cash Capital Expenditure (INR Mn) 16,054 1,947 Mar'21 FY20 2,288 FY21 4 Note: (1) Net Worth refers to sum of equity share capital and other equity. (2) Net Cash refers to Cash and Bank Balances less Non-current borrowings (including current maturities). (3) Net Working Capital refers to Current assets (excluding cash and bank balances) less Current liabilities. GLAND#5Financial Highlights (3/3) Focus on Capital efficiency and healthy return ratios Asset Turnover Ratio (1)(2) 0.7 0.6 2.8 2.4 Total asset turnover Fixed asset turnover ■Mar'20 Mar'21 Cash Flow from Operations (INR Mn) 7,009 FY20 6,049 FY21 ROCE (3) / RONW (4) (%) 32% 21% 21% 33% 17% 17% Mar'20 Mar'21 *ROCE (Ex-Cash) ROCE RONW Cash Conversion Cycle (CCC) (5)(6) (# of Days) 90 83 71 262 231 174 128 73 57 224 229 200 Receivable days Inventory days Payable days Cash conversion cycle FY19 FY20 ■FY21 5 Note: (1) Asset Turnover is calculated as Total Income for the year divided by total assets on the last day of the year; (2) Fixed Asset Turnover is calculated as Total Income for the year divided by total fixed assets (Property, plant and equipment on the last day of the year + Right-of-use assets + Capital work in progress on the last day of the year; (3) Return on Capital Employed (ROCE) Profit for the year / Capital Employed on the last day of the year. Capital Employed represents Total Assets - Current Liabilities; (4) Return on Net Worth (RONW) = Profit for the year / Net Worth on the last day of the year. Net Worth represents sum of equity share capital and other equity; (5) COGS means cost of goods sold includes cost of materials consumed, purchases of traded goods, change in inventories of finished goods, traded goods and work-in-progress and manufacturing overheads (6) Receivable days calculated as current trade receivables as on balance sheet date divided by revenue from operations * over 365 days, inventory days calculated as inventory as on balance sheet date divided by COGS* over 365 days, & payable days calculated as trade payable as on balance sheet date divided by COGS* over 365 days. CCC calculated as Receivable days + Inventory days - Payable days GLAND#6P&L Highlights YOY YOY Amount in INR Q4 FY21 Q4 FY20 FY21 FY20 Q3 FY21 growth growth Revenue From operations 8,877 6,352 40% 34,629 26,332 32% 8,594 Other Income 473 462 2% 1,348 1,392 -3% 351 Total income 9,350 6,814 37% 35,977 27,724 30% 8,945 Gross Margin (1) 4,962 3,797 31% 19,710 15,312 29% 4,526 % margin 56% 60% 57% 58% 53% EBITDA (2) 3,749 2,861 31% 14,370 10,946 31% 2,994 % margin (3) 40% 42% 40% 39% 33% PBT 3,489 2,615 33% 13,348 9,929 34% 2,732 % margin 37% 38% 37% 36% 31% PAT 2,604 1,948 34% 9,970 7,729(4) 29% 2,041 % margin 28% 29% 28% 28% 23% 6 Note: (1) Gross Margin = Revenue from Operations - Materials consumed; (2) EBITDA stands for earnings before interest, taxes, depreciation and amortisation which has been arrived at by adding finance expense, depreciation expense and total tax expense to the profit for the year; (3) EBITDA margin = EBITDA / Total Income; (4) In Sep 2019, Government of India announced the new Income tax rate. In Q2 FY20 the income tax rate of the company was changed from 34.94% to 25.17% and due to that there was one time impact in Deferred Tax amounting to INR 324 Mn in FY20 GLAND#7USA, Europe, Canada and Australia (Core Markets) 7 Revenue: Continuing on our strategy to strengthen product portfolio, we launched key products like Micafungin, Bivalirudin and Ziprasidone in core markets which has helped maintain strong growth. We have also seen strong volume based growth for our core portfolio of products. ■ New launches: Q4 FY21: 16 Product SKUS (10 molecules) FY21:47 Product SKUS (28 molecules) ■ US filings update: As of March 31, 2021, we along with our partners had 284 ANDA filings in the United States, of which 234 were approved and 50 pending approval. FY21: Rs. 23,610 Mn YoY Growth: 22% Q4 FY21: Rs. 6,193 Mn YoY Growth: 29% Core Markets (1) Revenue Contribution Q4 FY21 12M FY21 ANDA Filed ANDA Approved DMFS Filed 2 8(2) 21 LO 32(3) 5 FY20 FY21 61% 6% 67% 7% USA Europe, Canada and Australia Note: ANDA count includes technology transfer ANDAS (1) Core markets includes USA, Europe, Canada and Australia (2) Received first Penem approval for the US market - Ertapenem (3) Includes 5 tentative approvals GLAND#8Rest of the World Markets 8 ■ Rest of the world markets sales has been driven by new partnerships and increased penetration geographically ■ We are seeing repeat demand from new partnerships entered in to during the year, on account of our ability to respond to the changing market demand during COVID ■ The strength of our portfolio coupled with our constant life cycle management of product helps us stay highly competitive in these growth markets Growth momentum continues in Asia and LatAm, our focus remains on building partnerships in the region sustainable. sustainable business FY21: Rs. 5,455 Mn YoY Growth: 136% Q4 FY21: Rs. 1,436 Mn YoY Growth: 196% Rest of the World Markets FY20 Revenue Contribution 9% 16% FY21 GLAND#9Domestic Market 9 Domestic market sales remain steady and have shown 19% growth in FY21 ■ The new capacities being made available for the domestic market has helped ramp up volume growth in the core portfolio of products ■ We ramped up Remdesivir supply for the domestic market considering the requirement for Indian patients ■ New launches: FY21: 10 Product SKUs (6 molecules) FY21: Rs. 5,564 Mn YoY Growth: 19% Q4 FY21: Rs. 1,248 Mn YoY Growth: 15% Domestic Indian Market FY20 Revenue Contribution 18% 16% FY21 GLAND#10Near Term Focus Areas Focus on achieving a diverse product mix offering products at various stages of their lifecycle as well as a robust product pipeline Operational integration of biologics facility into Gland and additional capability building on vaccine drug substance manufacturing. We also look to continuing investments towards creating robust infrastructure for the vaccine and bio-similar space 10 10 Expanding development and manufacturing capabilities in new delivery systems such as pens and cartridges Expanding development and manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products Geographic expansion in to emerging markets to diversify revenue base while maintaining healthy profitability GLAND#1111 Responding to COVID-19 Safety First Put in adequate safeguards to ensure health and safety of employees and their family by taking precautionary measures; social distancing, workplace fumigation and sanitization across all plants Continuity of operations Efficient production planning, resource allocation through regulatory efforts, accelerated replenishment and logistic preparedness ensured our operations were uninterrupted Efforts to guarantee ramping up supply of life saving drugs like Remdesevir Helping the society Address medical infrastructure shortages, contributing ventilators/PPE Kits Distributed food, grocery kits, masks and sanitizers to the needy and poor families Contributed towards sanitization of government schools Distributed cooked meals and happiness boxes during the lockdown GLAND#12GLAND GLAND PHARMA LIMITED Investor Presentation Gemcitabl Injection Gemcitabi Injection Gemcitab Injection#13Snapshot 13 * Extensive and Vertically Integrated Injectables Manufacturing Capabilities 7 Manufacturing Facilities - 4 Finished Formulation and 3 API Greater Control Over Manufacturing Processes Consistent Compliance Track Record with Range of Regulatory Regimes No Warning Letters from USFDA Since Inception of Each Facility 284 ANDA Filings in the US (1) (2): 234 Approved; 50 Pending Approval Diversified B2B-led Model Across Markets Complemented by a Targeted B2C Model in India Wide Portfolio of Complex Products Supported by Internal R&D Successful Track Record of Operating B2B Model with Leading Pharma Companies Portfolio of Injectable Products Across Therapeutic Areas and Delivery Systems Exports to Over 60 Countries(1) Centralized R&D Laboratory with Team of ~268 Personnel Track Record of Growth and Profitability from a Diversified Revenue Base FY18-21 (3): Revenue CAGR: 29% PAT CAGR:46% EBITDA margin (4)(5) FY20 (3): 39% | FY21: 40% PAT margin (5) FY20: 28% | FY21: 28% Note: (1) As of March 31, 2021. (2) Filed by Gland Pharma, along with partners. (3) Based on Financial Information prepared in accordance with Ind AS (4) EBITDA stands for earnings before interest, taxes, depreciation and amortization which has been arrived at by adding finance expense, depreciation expense, exceptional items and total tax expense to the profit for the year. (5) EBITDA margin = EBITDA / Total Income; PAT margin = PAT / Total Income. GLAND#14Journey Launch of Enoxaparin Sodium Injection (Cutenox) in India and Rest of the world markets Incorporation by P.V.N. Raju Received USFDA approval for the facility at Dundigal manufacturing Launched Heparin Sodium Injection in the US BGV Hamburg (Germany) approval for Dundigal facility Received ANDA approval for Enoxaparin Sodium Injection USP Received ANDA approval for first Ophthalmic product USFDA and EU approval for Oncology plant, Vishakhapatnam SEZ Filed first ANDA from Penems facility USFDA approval for facilities at Visakhapatnam, Visakhapatnam SEZ and the manufacturing facility at Pashamylaram Commenced commercial sales in the US from Pashamylaram facility First OTC launch in US market for Olopatadine ophthalmic solution Listed on Indian stock exchanges, NSE & BSE 14 1978 2000 2003 2004-05 2007 2010 2012 2014 2016 2018 2017 2020 2021 2019 Set up In-house R&D facility at Dundigal, Hyderabad Capital infusion of ~1,000 million pursuant to PE investment Commissioned Pashamylaram unit Land leased at Vishakhapatnam SEZ on which Oncology facility and API facilities situated PE investment of US$ 200mn from KKR Fosun Singapore acquired 74% stake Commission of Asset First filing with National Medical Products Administration, China, and received clinical waiver for Dexrazoxane Investor/Capital Infusion Purchased assets of Vitane Biologics, Hyderabad based biopharmaceutical company Entered agreement with RDIF to supply upto 252 million doses of Sputnik V COVID-19 vaccine Launch/Filings GLAND#15Business Overview 15 Extensive and Vertically Integrated Manufacturing Capabilities With Consistent Compliance Track Record 4 Finished 7 Facilities Formulation Facilities & 767 million units 3 API Facilities 11,000 kg/year and R&D Pilot Plant 3 API facilities provide in-house manufacturing capabilities for critical APIs, thereby Dundigal, Hyderabad Sterile Injectables Facility (Flagship) API Facility Pashamylaram, Hyderabad Sterile Injectables Facility Penems Facility Consistent Compliance Track Record ⚫ No USFDA warnings letters since inception of each facility ⚫ Certified as GMP compliant at all manufacturing facilities by the USFDA ⚫ Certain facilities certified by the MHRA (UK), ANVISA (Brazil), AGES (Austria), TGA (Australia) and BGV Hamburg (Germany) Note: (1) As of March 31, 2021. Vishakhapatnam Oncology Facility 2 API Facilities ° Controlling costs and quality, and • Mitigating supply chain related risks around key product Quality Assurance and Quality Control • • • Team of 1,191 full-time employees, 30.07% of total employees (1) Regular quality management reviews 35+ audits per year on average, including customer audits and regulatory agency audits GMP certifications for facilities GLAND#16Business Overview (Cont'd) 16 Diversified B2B-led Model Across Markets Complemented by B2C Model in India • Operating in 60+ countries as of March 31, 2021 • One of the fastest growing generic injectables-focused companies by revenue in the US from 2014 to 2019 (1) ° Successful track record of operating B2B model with leading companies, complemented by a B2C model in home market of India leveraging brand strength and sales network B2B - IP Led Own Filing Partner Filing Out-license to Marketing partners Long term product supply contracts Overview B2B (Global) B2B Tech Transfer • • Co-development with Partner Manufacturing by Gland B2B CMO Fill and finish service Loan and license agreements B2C (India) B2C Direct marketing of products • License and milestone payments ⚫ Tech transfer fee Fixed per unit price • Direct sale of products Revenue Model ° Selling price per unit dose + Profit Share • Selling price per unit dose + Royalty ANDA Ownership(2) IP Ownership(2) Advantages of B2B models Co-owned * * Grow market share while reducing the marketing investments Leverage reputation of marketing partners Note: (1) As per IQVIA Report. (2) Reflects typical features of such business models in regulated markets. × × Build reputation as a complex injectables manufacturer with compliance record Drive profitability with higher capacity utilization GLAND#17Business Overview (Cont'd) 17 Extensive Portfolio of Complex Products Internal R&D & Regulatory Capabilities Present in sterile injectables, oncology and ophthalmics, and focus on complex injectables, NCE-1s, First-to-File products and 505(b)(2) filings • Delivery Systems: Liquid vials Lyophilized vials • Ampoules Bags • Pre-filled syringes • Drops Centralized R&D Laboratory located at Dundigal, Hyderabad facility, with supporting personnel at each manufacturing facility ~268 personnel team including PhDs, pharmacy post graduates and chemists Plan to set up a new R&D building at Pashamylaram, Hyderabad R&D expertise supports regulatory filings globally ° Anti-diabetic • Anti-infectives Anti-malarials Therapeutic Areas: • Neurological and Central Nervous System Ophthalmics and Otologicals Pain, neuro-muscular analgesics Anti-neoplastics (Oncology) blocking agents • 0 Blood-related Respiratory • Vitamins, minerals & • Cardiac nutrients Gastro-intestinal • Hormones Note: (1) As of March 31, 2021; refer to ANDA filings by Gland Pharma, along with partners. • . Regulatory Track Record 284 ANDA Filings in US - 234 approved; 50 pending (1) Of 284, 114 owned by Gland Pharma out of which 84 are approved and 30 are pending for approval 204 for sterile injectables, 53 for oncology and 27 for ophthalmics related products 1,501 product registrations globally, of which 389 in United States, Europe, Canada and Australia, 69 in India and 1043 in Rest of the world (1) GLAND#18Key Strengths 18 6 Experienced and Qualified Management Team 5 Track Record of Growth and Profitability from a Diversified Revenue Base with Healthy Cash Flows 4 Extensive Portfolio of Complex Products Supported by Internal R&D and Regulatory Capabilities GLAND GLAND PHARMA LIMITED Note: (1) 3 API facilities provide in-house manufacturing capabilities for critical APIs. 32 ANDAs covering key products are supported by in-house APIs Injectables: One of the Fastest Growing and Largest Segment 1 Extensive and Vertically Integrated Injectables Manufacturing Capabilities (1) Diversified B2B-led Model Across Markets, Complemented by Targeted B2C Model in India 3 2 GLAND#19Injectables: One of the Largest and Fastest Growing Segment 19 1 Injectable formulations is the fastest growing segment in global pharmaceuticals, recording a 2014-2019 CAGR of 10.1% vs overall pharma market at 5.8% Growth Opportunity Global generic injectables market is estimated at c.US$131bn growing at a 2014-19 CAGR of c. 8% US the largest market (i.e. c. 33-34% of market) is expected to grow at a c.16% CAGR from 2019-2024E c.US$61.3bn in injectable brand sales expected to lose patent protection between 2020-24 (vs c. US$33bn in sales which lost patent protection lost between 2014-19) 2 Growth Drivers for Injectables Rising prevalence of chronic diseases Convenience and benefits of New Drug Delivery Systems ("NDDS") New market opportunities Drug shortages in the US – from 2014 to 2019 c. 40-60% of the shortages have been in injectables space 3 Market Entry Barriers High capital investments Manufacturing complexities to meet stringent quality standards High level of compliance and regulatory requirements Consolidation trend expected to favour established players Source: IQVIA Report. GLAND#20Generic Injectables: Growth Opportunity US$131bn Market with Multiple Growth Levers Driven by LoEs, Opportunity from Shortages and Ease of Use Sizeable Injectable Market ... Injectable is a >US$400bn market Growing Faster than Broader Market with Robust Growth in Generics Injectable recorded CAGR of 10.1% vs broader market at 5.8% Global Injectable Market Global Pharma - Drug Delivery Mix 14-19 Key injectable markets like US, Europe and India demonstrated double digit/high single digit growth Geographic Mix- Generic Injectable 14-19 Global Pharma 826 1,096 CAGR CAGR Market Size (US$bn) 131 (US$bn) 1,096 (US$bn) 6% 8% 32% 39% 826 174 3% 89 c.10% CAGR 432 147 1 432 267 10% 30 267 14 412 490 4% 18 2224 34 9% 20 3% 29 6% 10% 46 25 13% 2014 2019 2014 2014 2019 Oral Solids ■Injectable Others ■North America 2019 Europe China India LOE Offering Significant Opportunity Significant increase in value of injectable brand sales scheduled to lose exclusivity Loss of Exclusivity - Injectables (US$bn) 33 61 2014-19 2019-24 Demand Driven by Drug Shortages c.40-60% of US drug shortages are in injectables Accessibility and Ease of Use Convenience and benefits of New Drug Delivery Systems driving growth across delivery formats Global Injectable Market 14-19 (US$bn) CAGR (% Injectables Share) 45% 45% 63% 58% 55% 39% 432 10% 66 10% 267 97 (#) 5% 42 84 102 57 61 101 77 131 78 15% 67 83 97 64 85 102 65 138 11% 81 2014 2015 2016 2017 2018 2019 2014 2019 20 20 ■Injectables ■Non-Injectables Source: IQVIA Report. Note: MAT September 2014-2019. (1) Generic Injectable market share as a percentage of overall injectable market in the respective country. Infusions Pre-filled Syringes Vials Others GLAND#21Generic Injectables: Growth Drivers 21 Injectables Segment has Demonstrated the Fastest Growth among Delivery Formats Increase in the prevalence of diabetes and other chronic diseases where treatment is primarily administered through injectables Drug Shortages in the United States: c.40% of the overall drug shortages between 2014- 18 in the US are in injectables 1 Injectables LO 4 Source: IQVIA Report, American Society of Health-System Pharmacists (ASHP) website. 2 Convenience and benefits of New Drug Delivery Systems ("NDDS") like auto injectors, pre-filled syringes etc. 3 New Market Opportunities: Heavy investments in the development of new complex molecules to target new ailments which are increasingly being treated via injectables GLAND#22Generic Injectables: Market Entry Barriers 2 Manufacturing Complexities to Meet Stringent Quality Standards Complexities involving sterilisation, packaging, sterile fill/finish, with stability assessment at each stage, among others 3 High Level of Compliance and Regulatory Requirements High level of regulatory enforcement of cGMP standards 1 Significant Capital Investments Injectable plants require 1.3x - 1.5x more capex vs oral solids plants due to requirements of sterilisation and/or aseptic manufacturing 22 22 GLAND 4 Stringent Quality Requirements c.62% of drugs in shortage are associated with manufacturing or product quality problems For the US Generic Injectables Market, c.70% of the Market by Value has Less than Half the Number of Manufacturers Compared to the Oral Solids Segment Source: IQVIA Report. GLAND#23Extensive & Vertically Integrated Manufacturing Capabilities Overview Manufacturing Footprint 23 00000 7 Facilities Dundigal, Hyderabad Sterile Injectables Facility (Flagship) Liquid Vials, Lyophilizers, Ampoules, Pre-filled syringes, Bags and Ophthalmics API Facility USFDA (US), MHRA (UK), ANVISA (Brazil), TGA (Aus), BGV (Germany) 4 Finished Formulation Facilities 3 API Facilities • R&D pilot plant Dundigal, Hyderabad 11,000 kg/year 767 million units & R&D Pilot Plant 23 production lines with flexibility to accommodate different product requirements In process of commissioning additional capacity Plan to set up a new R&D building at Pashamylaram, Hyderabad Greater control over costs and quality and mitigate supply chain related risks Pashamylaram, Hyderabad Pashamylaram, Hyderabad Sterile Injectables Facility • Liquid Vials, Lyophilizers, Ampoules and Pre-filled syringes Penems Facility Vials (2 Lyophilizers), Dry Powder USFDA (US), GUB Munich (Germany) Vishakhapatnam Oncology Facility • Liquid Vials, Lyophilizers 2 API Facilities Visakhapatnam Cumulative capacity of 11,000 kg/year USFDA (US), AGES (Austria), TGA (Australia), ANVISA (Brazil), DMA (Denmark) GLAND#2424 Consistent Regulatory Compliance Track Record Highlights H No warning letters from USFDA (whether as a result of facility inspection or otherwise) since inception of each facility All facilities Certified GMP compliant by USFDA, and certain facilities by MHRA (UK), ANVISA (Brazil), AGES (Austria), TGA (Australia) and BGV Hamburg (Germany) WHO GMP certifications from the Drugs Control Administration (Governments of Telangana and Andhra Pradesh, India) (DCA) Focus on Quality Control ISO certifications as of March 31, 2021 (1) eiie 1,191 fulltime employees in Quality Control and Quality Assurance (2) 30.07% of the workforce in Quality Control and Quality Assurance (2) 35+ audits on average per year, including customer audit and regulatory agency audit Quality Standards throughout the business units Quality Improvement Laboratory Information Management System software for quality control at all manufacturing locations and facilities Corporate Quality Establishment Corporate reporting structure for identifying and developing standard operating procedures Quality Audits Conduct internal audits across all facilities on a quarterly basis Note: (1) 3 ISO certifications as of March 31, 2021 for quality management, environment management and occupational health and safety management systems applicable to design, development and production of pharmaceuticals and contract manufacture of small volume parenterals. (2) As of March 31, 2021 GLAND#25Diversified Business Model with Focus on Growth & Stability Diversified B2B-led Model Across Markets, Complemented by a Targeted B2C Model in India B2B - IP Led B2B (c.96% of FY21 Revenue) B2C (c.4% of FY21 Revenue) B2B Tech Transfer B2B CMO B2C Own Filing Partner Filing • Out-license to marketing partners • Co-development with Partner • Fill and finish service ⚫ Direct marketing of products Overview Long term product supply contracts • Manufacturing by Gland • Loan and license agreements Revenue Model • License and milestone payments . Tech transfer fee . Fixed per unit price • Direct sale of products Selling price per unit dose + Profit Share . Selling price per unit dose + Royalties × х (2) * ANDA Ownership (1) Development (1) IP Ownership (1) Marketing Rights (1) Royalty / Profit Sharing (1) Key Markets Select Clients / Partners Co-owned Global Pharma Companies ४ × × Not Applicable Indian Pharma Companies c.2,000 corporate hospitals, nursing homes & govt. facilities Note: (1). Information reflects typical features of the respective business models in regulated markets. (2). Exhibit batches and stability studies are performed by Gland. 25 GLAND#26Gland's B2B Model: Salient Features Advantages Include Stable Cash Flows, Better Profitability Profile, Margin Stability from Natural Hedge Against Raw Material Pricing and End-formulation Pricing Fluctuations 1 Steady/Predictable Cash Flow Long-term supply contracts with marketing partners ranging from 3-5 years Stronger partnerships due to lack of injectables manufacturers with good regulatory track record Products licensed to marketing partners strong in particular therapeutic areas resulting in higher market share 6 Lower R&D Litigation Risks Reduce risk by partnering with a marketing partner to cover R&D litigation expenses Revenue Growth: 2014-19 Gross Margins: 2019 2 Better Operating Profits Efficient cost profile due to relatively lower SG&A vs B2C players 15.4% 58.1% 40.1% 3.4% Gland B2C Players Gland B2C Players 3 5 Lower RM1 / Formulation Pricing Risk IP-led model helps generate revenue from transfer pricing and profit sharing Revenues and profits through transfer pricing are immune to raw material price fluctuations Transfer pricing also helps regulate any adverse impact from price erosion in end-formulations, as it gets restricted to the profit share component 4 Lower Working Capital Requirement Lower requirements due to better inventory management, planned payables and better visibility on receivables Economies of Scale Due to differentiated B2B Model, Gland can derive scale benefit at a product as well as formulation level 26 26 Gland has Demonstrated Faster Revenue Growth in Last 5 Years While Generating Superior Margins vs B2C and B2B Players Source: IQVIA Report. Note: (1) RM- Raw Material. GLAND#27Complex Product Portfolio Supported by Strong R&D... Expertise in synthesis of complex drug molecules: Low Molecular Weight Heparins ■ Steroids 27 27 Cytotoxics Present in: • Right Capability Matrix in Products and Delivery Systems Focused on: ■ Complex injectables Oncology Ophthalmics and Otologicals Blood-related Neurological and Central Nervous NCE-1s Expanding capabilities in: Peptides " Long-acting First-to-File products injectables · Suspensions System 505(b)(2) filings Hormonal products • Pain, neuro-muscular agents and " Biosimilar Expanding in new delivery systems: ☐ Pens Cartridges Key products include: Cis-Atracurium Besylate Enoxaparin Sodium Heparin Sodium ■ Rocuronium Bromide analgesics Significant R&D Investment Translating into Revenue From New Launches Centralized R&D team of c.268 members including PhDs, pharmacy post graduates and chemists Track record of coming up with new complex products 3.8% 4.7% 3.5% 3.5% 22% 13% 9% 11% 1,220 966 922 45 51 57 615 3,493 3,660 2,717 2,292 FY18 FY19 FY20 ■Total R&D expenditure (mn) R&D expenditure as % of revenue from operations FY21 FY18 FY19 FY20 FY21 ■Revenue from new product launch (mn) As % of revenue from operations #products launched GLAND#28...Supported by Proven Regulatory Capabilities Product Development Capabilities Supported by Regulatory Expertise and Track Record in Filing and Approval of Large Number of Product Registrations 28 Established Expertise Broad Range of Filings Successful track record and pipeline Constantly engaged with regulators including the USFDA Geographic Breakdown (FY21) Total 284 ANDAS (1) Different jurisdictions ☐ Diverse dosage forms ■ ANDA filings for sterile injectables (204), oncology (53), ophthalmics (27) 50 284 20 234 30 170 150 60% 64% 84 36% 40% 114 RoW 16% Approved Pending Total Australia 0.5% Owned Partner Owned Canada 2% Revenue Supportive filings to drive sustainability ■ Undertaking CBE filings for site and line changes ■Timely filing of applications like CBE/PAS for alternate APIs and components Global Platform of Approved and Filed Registrations Extensive experience in regulatory requirements of key markets to facilitate new product registrations Total 1,478 Product Registrations Globally1 1043 Europe 4% from operations India 16% *34bn US 61% 389 US, Canada, Europe, Australia Note: (1) Information in relation to the product filings and registration is as on March 31, 2021 69 India RoW GLAND#29Focus on Lifecycle Management of Products Focus on Lifecycle Management of Products Across Manufacturing, R&D and Supply Chain Processes to Maintain Competitive Advantage Over Peers Vertical Integration as Differentiator ■ Ability to vertically integrate and manufacture critical API which are: Difficult to source Have risk of uncertainty of API supply ■ Cost implication Supply Chain Efficiencies Efficient supply chain management with focus on: ■ Curtailing supply chain costs through optimal inventory levels; Economic order quantities ■Timely filing of applications for alternate APIs and components 29 29 GLAND Operational Efficiencies Ability to maintain cost competitiveness via efficient management of production costs including the following among others: Qualifying additional manufacturing lines/sites Batch Size Increase R&D Continuously work on developing better and economical analytical methods and efficient manufacturing processes like Lyo parameters, increased hold times etc. GLAND#3030 30 Corporate Governance Framework Based on Independent Board Name Board of Directors Yiu Kwan Stanley Lau Profile • Bachelor's degree in pharmacy from The School of Pharmacy, University of London Chairman and Independent Director . Director on the board of Solasia Pharma K. K. and TaiLai Bioscience Ltd . Master's degree in science (pharmaceutics) from Long Island University, New York • Master's degree in business administration from University of Baltimore; Srinivas Sadu MD and CEO Qiyu Chen Non Executive Director Yifang Wu Non Executive Director Dongming Li Non Executive Director • • • • • Post graduate certificate in finance & management from London School of Business & Finance Bachelor's degree in genetics from Fudan University Master's degree in business administration from China Europe International Business School Global partner of the Fosun Group Masters of administration in communication from Saint Joseph's University (Philadelphia) Chairman and CEO of Shanghai Fosun Pharmaceutical (Group) Co. Ltd • Bachelor's degree in science from Fudan University Xiaohui Guan Non Executive Director . . Co-president of Shanghai Fosun Pharmaceutical (Group) Co Ltd Master's degree in professional accountancy from the Chinese University of Hong Kong Member of the Association of Chartered Certified Accountants and a non-practising member of the Shanghai Institute of Certified Public Accountants Senior vice president and CFO of Shanghai Fosun Pharmaceutical (Group) Co. Ltd Udo Johannes Vetter • Bachelor's degree in science (pharmacy) from the University of Washington Non Executive Director Essaji Goolam Vahanvati Independent Director Satyanarayana Murthy Chavali Independent Director • . Associated with Vetter / Vetter Pharma group of companies since 1987 and currently, chairman on board of Vetter Pharma (Corporation) • Bachelor's degree in law from Government Law College, Mumbai Working as independent legal practitioner, practicing in the Supreme Court of India and Delhi High Court Bachelor's degree in technology from Indian Institute of Technology, Madras Post graduate diploma in management from Indian Institute of Management, Bangalore Bachelors degree in Economics from Delhi University and Masters of business administration from Harvard Business School Naina Lal Kidwai Independent Director • Former President of the Federation of Indian Chambers of Commerce and Industry Dr. Jia Ai Zhang • Bachelor Degree in Pharmacy from Fudan University and PhD in Pharmaceutics from Oregon State University Non Executive Director • Executive President at the Global R&D center of Fosun Pharma GLAND#31Professional and Experienced Management Team Qualification 31 Name Management Team Srinivas Sadu Managing Director and Chief Executive Officer Ravi Shekhar Mitra Chief Financial Officer KV G K Raju Chief Technology Officer Master's degree in science (pharmaceutics) from Long Island University, New York Master's degree in business administration from University of Baltimore; Post graduate certificate in finance & management from London School of Business & Finance • Bachelor's degree in commerce from University of Calcutta • Associate member of the Institute of Chartered Accountants of India • Associate member of the Institute of Company Secretaries of India . Bachelor's degree in science from Andhra University CS Venkatesan Senior Vice President - R&D Surapanini Sridevi Senior Vice President - R&D Prakash Baliga Vice President - Strategic Sourcing, Procurement & Commercial Ashish Adhikari • • Master's degree in science in organic chemistry from Annamalai University Doctor of philosophy degree from the Indian Institute of Science, Bangalore • Master's degree in pharmacy from Banaras Hindu University Doctor of philosophy degree in pharmaceutical science from Osmania University Master's degree in pharmacy from Bangalore University • Master's degree in engineering from Lamar University, Texas Vice President - Operations Shilpi Sahay • Executive general management programme from the Indian Institute of Management, Bangalore • Bachelor's degree in science from the Fergusson College, University of Pune Deputy General Manager of Human Resources • Executive diploma in human resource management from XLRI, Jamshedpur Susheel Ogra Senior General Manager of Sales and Marketing Sampath Kumar Pallerlamudi Company Secretary and Compliance Officer • Bachelor's degree in science from Maulana Azad Memorial College, University of Jammu Bachelor's degree in law from Andhra University Faculty of Law Post graduate diploma in business management from Institute of Public Enterprise Associate member of the Institute of Company Secretaries of India GLAND#32Promoted by Shanghai Fosun Pharma Shanghai Fosun Pharma is Global Pharmaceutical Major with Extensive Pharmaceutical Manufacturing, Distribution and R&D Expertise Globally FOSUN PHARMA 复星医药 Fosun Pharma is a Global pharmaceutical major, whose shares are listed on the Shanghai Stock Exchange and the Stock Exchange of Hong Kong Limited (1) Relationship with Shanghai Fosun Pharma provides widened market access opportunities arising from its own continuing internationalization Benefitted from Shanghai Fosun Pharma's established presence in China and Africa, both of which we consider to be key growth markets for injectables Continue Strategic Alignment with Shanghai Fosun Pharma to Increase Market Reach Leverage existing infrastructure and global presence to access new markets, including China and Africa Benefit from regulatory know-how to navigate the rapidly evolving healthcare landscape in China 32 32 (1) Market cap of US$ 15.0 bn as of March 31, 2021. Benefit from bargaining power and scale to procure raw materials & equipment from China Access extensive sales, logistics and distribution network to enable market penetration in China Leverage ability to access key markets to provide coverage for a portfolio of products GLAND#3333 33 Building Blocks to Implement Future Strategy Increase Current Market Presence and Enter New Markets Align with Shanghai Fosun Pharma to Increase Market Share Pursue Strategic Acquisitions and Partnerships Continued Focus on Cost Management ااس 6 Expand Product Portfolio and Delivery Systems 1 Continue to Invest in Manufacturing and Technological Capabilities * 2 3 4 5 GLAND#3434 Proven Track Record of Financial Performance Revenue from Operations (INR Mn) FY 18-21 Growth and Profitability from a Diversified Revenue Base CAGR: 29% 20,442 16,229 FY18 FY19 EBITDA (1) / EBITDA Margin (2) (INR Mn / %) FY 18-21 CAGR: 35% 34,629 40% 40% 26,332 37% 14,370 35% 10,946 7921 5841 FY20 FY21 Increase in Export Sales, Driven by 57 and 51 New Product Launches in FY21 and FY20 respectively FY18 FY19 FY20 FY21 EBITDA has Grown at 35% CAGR from FY18 to FY21 PBT/PAT / PAT Margin (3) (INR Mn / %) FY 18-21 CAGR: 46% 28% R&D Expenses / R&D (% of Revenue) (INR Mn / %) 28% 21% 13,348 19% 6,863 5,015 4,519 3,211 9,929 9,970 7,729 3.5% 4.7% 3.5% 1,220 3.8% 966 922 615 FY18 FY19 FY20 FY21 ■Profit Before Tax Profit After Tax FY18 FY19 FY20 FY21 Increasing PAT Margin Given No Significant Borrowings and Adoption of New Concessional Tax Rate (FY20) In-house Centralized R&D Lab with Nearly 268 Scientists Note: (1) EBITDA stands for earnings before interest, taxes, depreciation and amortization which has been arrived at by adding finance expense, depreciation expense, exceptional items and total tax expense to the profit for the year (2) EBITDA margin = EBITDA / Total Income; (3); PAT margin = Profit for the year / Total Income Margin GLAND#35Proven Track Record of Financial Performance (Cont'd) Net Worth (1) (INR Mn) Strives to be a Capital Efficient Business. Company has no Significant Borrowings Cash and Bank Balances / Net Cash (2) (INR Mn) 35% CAGR 59,032 36,462 28,620 24,104 FY18 FY19 FY20 Strong Profitability Driving Growth in the Capital Base FY21 13,252 13,202 6,708 6,649 7,533 7,479 30,058 30,017 FY18 FY19 ■Cash and cash equivalents FY20 FY21 Net Cash Maintained a Significant Net Cash Position over the Last 3 Years Asset Turnover Ratio (3)(4) ROCE (5)/RONW (6) 2.8 (%) 2.4 0.7 2.0 0.6 0.6 0.6 1.6 Asset Turnover FY18 ■FY19 ■FY20 FY21 Fixed Asset Turnover Consistent Improvement in Asset Utilization to Generate Revenue 33% 32% 20% 21% 17% 17% 15% 21% 13% 17% 16% 13% FY18 FY19 ROCE (ex-cash) FY20 FY21 ROCE RONW Consistent Improvement in Profitability 35 Note: (1) Net Worth refers to sum of equity share capital and other equity. (2) Net Cash refers to Cash and Bank Balances less Non-current borrowings (including current maturities). (3) Asset Turnover is calculated as Total Income for the year divided by total assets on the last day of the fiscal year. (4) Fixed Asset Turnover is calculated as Total Income for the year divided by total fixed assets (Property, plant and equipment on the last day of the fiscal year + Right-of-use assets + Capital work in progress on the last day of the fiscal year). (5) Return on Capital Employed (ROCE) = Profit for the year / Capital Employed on the last day of the fiscal year. Capital Employed represents Total Assets - Current Liabilities. (6) Return on Net Worth (RONW) Profit for the year / Net Worth on the last day of the fiscal year. Net Worth represents sum of equity share capital and other equity; GLAND#36GLAND Registered Office Gland Pharma Limited Survey No. 143-148, 150 & 151 Near Gandimaisamma 'X' Roads D.P. Pally, Dundigal Gandimaisamma Mandal Medchal-Malkajgiri District Hyderabad 500043, Telangana, India BSE 543245 ONSE GLAND Bloomberg GLAND:IN

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare