Strategic Vision: A Global Pharma Company

Made public by

sourced by PitchSend

15 of 23

Category

Healthcare

Published

FY22

Slides

Transcriptions

#1Atorvastatin Calcium blets USP LUPIN Investor Presentation FY 2021-22 19th May 2022#2Safe Harbor Statement LUPIN Materials and information provided during this presentation may contain 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. Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents obtained by competitors. Challenges inherent in new product development, including completion of clinical trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting domestic and foreign operations. Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. The Company does not undertake any obligation to update forward-looking statements to reflect new information, future events, or otherwise after the date thereof. 2#3Strategic Vision: A Global Pharma Company Focused on our Core Growth Platforms India Region Achieving substantially above market growth Organic and in-organic growth, in our therapeutic areas and beyond, positioning us as the partner of choice for innovative pharmacos Complex Gx Platforms Substantial and scaled product platforms Purposefully scaling our Inhalation, Injectables and Biosimilars across our footprint of Global businesses Global Developed Gx market footprint Operational efficiency from Global presence Building operating leverage in CAPEX and R&D across markets with similar regulator regimes (i.e., US, UK, Europe, Canada and Australia) Top-decile Delivery of On-time Launches Continuous Improvement Culture Best in Class Global Quality LUPIN 3#4Industry trends Price erosion has become business as usual for US Gx Global Inflationary Head Winds Need for low competition launches India growth to remain strong LUPIN FDA resumes world-wide site inspections $ • Pressure has increased from both competition and purchasing groups YoY price decline of 7% in January, accelerated to 16% in February Risk of high input prices to API/KSM pricing and utility costs • FY23 margins likely challenged across industry from higher input costs • Discontinuations likely high due to compressed industry margins Excellence in R&D more important than ever to driving top-line ⚫ Due to erosion, the only proven path to growth is exclusive or otherwise low competition launches . Growth likely to revert to historical range of 10-12% High growth potential, but substantial hurdle to grow beyond market • Industry M&A and diversification seen increasing in FY23 Pipeline products stuck due to WLs With resumption of inspections by the US FDA, pipeline from Indian sites stuck due to warning letters could become available 4#5Lupin Today Financial Metrics Market Cap (3) US$ 4.0 bn Revenue (FY22)(4) US$ 2.2 bn EBITDA (FY22) (4) US$ 311 mn. FY22 Revenues split Globally 10th Largest Generic company (by sales¹) US 6th Largest Indian Pharma (by global sales¹) Major Markets 3rd Largest in the US (by prescriptions²) 6th India Pharma Market Rank² Netherlands 1 India 38% ΑΡΙ 6% Mexico 1 1 North America Brazil 36% 1 1 Growth ROW 2% EMEA 9% Markets 9% India 12 2 ◆ Manufacturing Research LUPIN 15 7 ■20,500+ Global employees ■Products sold in 100 countries ■30 bn+ extended unit capacity ■ API, Generics, Biologics, Specialty, NCE Mfg R&D sites sites ■ OSD, Injectables, Inhalation, Ophthalmic, Derm, LARCS 1. LTM sales as of 31st Mar 2022 2. IQVIA MAT Mar-22 3. As of May 18, 2022 4. Exchange rate used US$ 1 = INR 74.24 (Average for FY22) 5#6Q4 FY2022 Snapshot Sales (INR mn, YoY Growth) India, 13,511 Total 38,645, 2.8% North America, 14,162 Important developments Commercial Lupin Completes Acquisition of Brands from Anglo-French Completed Southern Cross acquisition in Australia Lupin and Yabao Announce Strategic Partnership in China Lupin and Axantia Enter into a License, Supply and Technology Sharing Agreement for Pegfilgrastim in the Middle East and North. Africa API, 2,203 ROW, 887 EMEA, Growth Markets, Pipeline 3,810 4,072 Received US FDA approval for : EBITDA R&D INR 2,823 mn INR 3,442 mn 7.3% % of Sales 8.9% % of Sales ➤ Sildenafil for Oral Suspension Vigabatrin for Oral Solution USP Arformoterol Tartrate Inhalation Solution Regulatory US FDA inspected Tarapur facility LUPIN 6#7North America US Generics: An established leader¹ 44 22.6% Number of products Market leader Albuterol Gx Market share 113 Q4FY22 36.6% YOY QoQ % of Sales -5.3% -10.2% LUPIN Managing our transition to Complex Generics US quarterly sales ($ mn) 202 Number of Products Top 3 by Market Share 195 184 181 172 3rd 160 196 Largest in the US Filings pending approval DMF filings (cumulative) Q4 FY21 Q1 FY22 Q2 FY22 Q3 FY22 Q4 FY22 (by prescriptions¹) (cumulative) Launched 2 products in Q4 in US (gTaytulla and gRenagel) bringing the total marketed generic products to 166 Current pipeline includes 53 FTFs incl. 21 exclusive FTF awaiting USFDA approval 1. IQVIA Mar-22 7#8India Business Update Q4FY22 35.0% YOY QoQ % of Sales 5.0% -8.3% LUPIN Q4 growth at 5% YoY; domestic formulations grew 13.3% YoY with contribution from key therapy areas India Quarterly Sales (INR mn) Lupin continues to outpace industry growth in Chronic 16,362 12,866 CAGR MAT Mar'18 - '22 15,435 Lupin Rank¹ 14,733 13,511 Therapy Market Lupin MAT Mar'18 MAT Mar'22 Acute Chronic 11% 6% 12 15 12% 14% 4 4 Cardiac 12% 14% 3 3 Anti-diabetics 11% Q4 FY21 Q1 FY22 Q2 FY22 Q3 FY22 Q4 FY22 16% 4 3 Respiratory 14% 15% 3 2 Strong Portfolio BRANDS RANK (MAT MAR'22) · GLUCONORM-G 44 3 in Top 100 HUMINSULIN 85 • BUDAMATE 96 ONDERO 215 • 8 in Top 300 IVABRAD 229 GIBTULIO 231 TONACT 265 AJADUO 269 6th Rank in IPM; 65% Chronic contribution For Lupin Respiratory & Gynae registered a double-digit growth in Q4 FY22 Two therapies- Cardiac & Anti Diabetics are above INR 1,000 Crore sales New divisions launched: Mind Next (CNS), Lupin Inspire (Diabetes) Maxter Neo (Anti-infective) 8#9Other Markets EU5 Australia South Africa Germany: EUR 8.4 mn sales in Q4 FY22 Tempil ® & Mens Health Portfolio have contributed to double-digit YoY growth 4th largest generics player¹ Growth of 30% against industry growth of 7.5%¹ 4th largest Rx generics player2; Market leader in CVS space Emerging markets Developed • ZAR 426 mn sales in Q4 FY22 Brazil Mexico BRL 64 mn sales in Q4 FY22 (up 8% YoY); In our reference market, MedQuimica ranks #6 in units and #14 in Values MXN 183 mn sales in Q4 FY22; (growth of 19% YoY) Market Leader in Ophthalmology (#2 in units and #5 in values) with a national footprint API + Global Institutional 1. IQVIA Midas Sales Audit MAT Dec-21 API revenues declined 14% YoY in Q4 FY22 Continued leadership in anti-TB Institutional business 2. IQVIA Feb-22 9 LUPIN#10P&L Highlights- Q4 FY 2022 LUPIN Amount in INR mn Q4FY22 Q3FY22 Sales Other operating income Total revenue 38,645 185 38,830 % of Sales 100.0% 40,875 100.0% 0.5% 734 1.8% 100.5% 41,609 101.8% % of QoQ Sales Growth % of YOY Q4FY21 Sales Growth -5.5% 37,593 100.0% 2.8% -74.8% 238 0.6% -22.3% -6.7% 37,831 100.6% 2.6% Gross Profit 22,323 57.8% 23,929 58.5% -6.7% 24,417 65.0% -8.6% (excl. other operating income) EBITDA¹ 2,823 PBT before exceptional item 1/2 -864 7.3% -2.2% 4,039 9.9% 1,671 4.1% -30.1% 7,657 20.4% -63.1% 5,182 13.8% Exceptional item -12 0.0% 0 PBT after exceptional item -852 -2.2% 1,671 0.0% 4.1% 0.0% 0.0% 5,182 13.8% Profit after Tax -5,119 -13.2% 5,491 13.4% 4,642 12.3% Profit/(Loss) for the period -5,180 -13.4% 5,455 13.3% 4,604 12.2% 1. In Q3 FY22, other expenses include the impact of one-time expenses of INR 1,932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years. 2. Depreciation & Amortization & impairment expense of Q4 FY22 includes INR 1,267 mn on account of impairment of Gavis IPs. 10#11P&L Highlights - FY22 LUPIN YOY Amount in INR mn FY2022 % of Sales FY2021 % of Sales Growth Sales 161,928 Other operating income 2,127 Total revenue 164,055 100.0% 1.3% 101.3% 149,270 100.0% 8.5% 2,360 1.6% -9.9% 151,630 101.6% 8.2% Gross Profit 97,116 60.0% 95,648 64.1% 1.5% (excl. other operating income) EBITDA¹ 23,073 14.2% 27,032 18.1% -14.6% PBT before exceptional item¹ 12,135 7.5% 16,751 11.2% Exceptional item 2/3 25,861 16.0% 0 0.0% PBT after exceptional item -13,726 -8.5% 16,751 11.2% Profit after Tax -15,097 -9.3% 12,266 8.2% Profit/(Loss) for the period -15,280 -9.4% 12,165 8.1% 1. 2. In Q3 FY22, other expenses include the impact of one-time expenses of INR 1,932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years. In Q2 FY2022 we had created a provision of INR 18,795 mn [including INR 375 mn towards litigation and settlement related expenses] under Glumetza class actions. The amounts due to the two plantiffs group was settled in Q3. We had a small reversal on account of litigation expense in Q4 of INR 12 mn. 3. Q2 FY2022 includes impairment expense of INR 7,077 mn for Solosec® IP. 11#12Key Financial Metrics 3,737 R&D (INR mn) 3,427 3,300 Capex (INR mn) 3,546 3,442 1,396 1,451 1,057 2,787 1,577 Q4FY21 Q1FY22 Q2FY22 Q3FY22 Q4FY22 Q4FY21 Q1FY22 Q2FY22 Q3FY22 Q4FY22 9.1% 8.8% R&D (% of Sales) 8.2% 8.9% 8.7% 0.05 Net debt/Equity 0.18 0.16 (0.02) (0.01) Q4FY21 Q1FY22 Q2FY22 Q3FY22 Q4FY22 Q4FY21 Q1FY22 Q2FY22 Q3FY22 Q4FY22 12#13Complex Generics and Biosimilars Opportunity Opportunities exist in products with barriers to entry Generics market offers opportunities in First to market / first to file opportunities Complex dosage forms like injectables, inhalation Complex categories market size (Brand + Generics) US$ bn¹ With several biologics going off-patent, biosimilars have a long way to go with new launches and incremental penetration in US and EU Top Biologics Global Sales US$ Bn² 882823220 10 90 83 70 65 60 50 Adalimumab Pembrolizumab Ustekinumab Insulin Glargine 18.5 14.1 13.9 Etanercept 10.6 Insulin Aspart 9.8 40 28 24 13 9 10 11 10 Nivolumab 8.8 Infliximab 7.7 Insulin Lispro 7.5 8 Dupilumab 7.1 Daratumumab 6.3 Injectables Inhalation Dermatology Ophthalmics Others Secukinumab 6.2 Bevacizumab 6.1 2017 2021 1. IQVIA MIDAS MAT Dec 2017 and Dec 2021 2. IQVIA MIDAS MAT Dec 2021 34.6 LUPIN 13#14Complex Generics and Biosimilars Opportunity R&D investments focused toward complex generics and biosimilars Products in development target US$ 70.7 bn of which complex categories account for ~85% Launches in key categories like Inhalation and biosimilars Several filings in each of the key categories underway Pipeline under development - Market Size Split¹ LUPIN First biosimilar filed in the US with several others under development Depot Injectibles 6% IUD / Implant 1% Complex injectables including depot injectables 1. Sales: IQVIA MAT Mar 2022/ Company reported sales Ophtal/Others 1% Multiple Complex orals with barriers to entry under development Orals 15% Biosimilars 30% $70 bn+ market Inhalation 25% Injectables 22% Inhalation pipeline delivery to accelerate in near term 14#15Evolving our Generic Portfolio and Pipeline by timing of material contribution 告 Injectables Robust suite of depot, liposomal, peptide and iron injectable products in development LUPIN Inhalation Scaling our early yet meaningful launches while advancing our robust pipeline of MDIs, DPIs, and SMIS Biosimilars ® Commercial momentum ex-US and evolving commercial capabilities in the US backed by exceptional R&D capabilities Women's Health Evolving internal LARC platforms and portfolio 15#16Progress on US Inhalation Pipeline Product (Market Size¹) Albuterol MDI Brovana AG Tiotropium DPI MDI 1 MDI 2 Formulation PK Study PD Study Filing Launched Launched in US Launched in US Tiotropium DPI is filed and under review PK Studies to commence shortly MDI 1 is filed MDI 3 MDI 4 PK Studies to commence shortly PK Studies to commence shortly MDI 5 DPI 1 DPI 2 1. IQVIA MAT Mar 2022 PK Studies to commence shortly PK Studies to commence shortly PK Studies to commence shortly Total Inhalation target market size of ~US$ 22.4 bn LUPIN 16#17Progress on US Injectables Pipeline Nanomi Pipeline Product (Market Size)¹ Risperdal Consta Depot 2 Formulation Clinical Phase Depot 3 LRP Complex injectables Pipeline Product Name (Market Size)¹ Product 1 Product 2 Product 3 Product 4 Filing LUPIN Risperidone is at end of clinical phase Depot 2 and Depot 3 are at end of formulation development stage API/RM/PM sourcing Q1/Q2 status Formulation and characterization Validation Registration batches Clinical Submission Product 1 has been filed Product 2,3 & 4 are at clinical stage Complex Injectables market size US$ 4.8 bn in depot; >US$ 17.5 bn in other complex injectables 1. IQVIA MAT Mar 2022 17#18Progress on Biosimilar Pipeline LUPIN Molecule Reference Product Clone & Process Development Pre- Clinical Phase I Phase III Filing in US/EU/JP US/EU/JP Approval Etanercept EnbrelⓇ Neulasta® (PFS & Pegfilgrastim Onpro) Ranibizumab LucentisⓇ Aflibercept Eylea® Denosumab Xgeva®, Prolia® Pertuzumab PerjetaⓇ Lupin0019 & Launch Launched in JP/EU/India/Thailand Filed: Canada/Australia and several other Emerging Markets US BLA Under review by FDA and several other markets. Launched in India. On-body-injector clinical trial ongoing. Global Phase III (US/EU/India) ongoing. India MAA received and Launch preparation ongoing Toxicology studies complete. IND in preparation. Phase III to be initiated shortly Toxicology studies complete. Toxicology studies complete. Clone Ready and Process finalization ongoing. 1. IQVIA MAT Mar 2022 Total Biosimilar target market size of ~US$ 36 bn¹ 18#19Improvement initiatives Optimization plan Idle Time Plant Work Force Optimization Write-offs Returns Air Freight Low Margin SKUS Key initiatives LUPIN Network Optimization Optimizing R&D investment FTS Integrated Business Planning 19#20Optimizing R&D investment Invested INR 14 bn or 8.7% of sales on R&D in FY22at 7 R&D sites globally R&D spend Generics filings Pipeline IR&D Cost (INR bn) R&D as % of Sales 25.0 13.5% 14% 457 cumulative filings 11.9% 20.0 10.5% 12% 10.3% 9.6% 8.7% 10% 15.0 160 pending 8% 23.1 approval 10.0 6% 18.5 15.0 15.5 14.3 14.0 4% 5.0 2% 53 First to files 0.0 0% (21 excl. FTFs) FY 17 FY 18 FY 19 FY 20 FY 21 FY 22 Optimizing R&D spend Targeting >US$ 188 bn brand + generics sales, of which • O Filed products target US$ 117.2 bn Products in development target US$ 70.7 bn of which complex categories account for ~85% 53 First-to-Files (FTF) filings including 21 exclusive FTF opportunities targeting US$ 5.9 bn IQVIA MAT Mar 2022/ Company reported sales LUPIN 20 20#21Lupin - Awards and Accolades • Vinita Gupta ranks among 50 Most Powerful Women in Business - by Fortune India Vinita Gupta, named among India's 20 Most Influential Women in Healthcare by BW Healthcare World Lupin wins two awards at the prestigious India Pharma Awards 2021 "BEST Award" from Association of Talent Development - 2022 • Lupin awarded 'Masters of Risk in Pharma & Healthcare' at India Risk Management Awards 7th Edition by CNBC-TV18 • Lupin named ‘Best Researcher of the Year' at the ETHealthworld.com India Pharmaworld Awards • Lupin Biotech wins 'Bioprocessing Excellence in South Asia' Award at the prestigious Asia Pacific Bioprocessing Excellence Awards 2022 • 3 sites rated 7 by ISRS (International Sustainability Rating System), the highest score in the pharma sector globally . ⚫ LupinLife's Be One wins the best packaging design, graphics and brand value add award at the India Packaging Awards 2021 • • Taxation Team for wins FOUR awards at the ITR Asia-Pacific Tax Awards 2021 by the International Tax Review Sreeji Gopinathan, Chief Information Officer, Lupin makes it to the coveted Futuristic 100 CIOs list Greentech Energy Conservation Awards 2021 for Outstanding Achievement in Energy Conservation. FORTUNE INDIA MCKESSON QASQ 2022 AMERICAN SOCIETY FOR QUALITY BE ST Award Winner Quality Circle Forum of India • Lupin's Mandideep and Pithampur Facility Wins Gold At The National Awards for Manufacturing Competitiveness (NAMC) ⚫ Lupin wins Silver at the prestigious India Health and Wellness Summit & Awards for Non-Communicable Disease (NCD) prevention campaign 'Shakti' for promoting awareness about heart diseases in women. • Lupin's Team Synox has been recognized for "Best Marketing Campaign of the Year" at the ETHealthworld India Pharma World Awards, twice in a row. BW Healthcare Healthworld.com INDIA PHARMA WORLD WORLD.com INDIA ISK MANAGEMENT AWARDS RISK MASTERCLASS India Packaging AWARDS Awards ITR Ⓡ ASIA-PACIFIC TAX AWARDS 2021 ⚫ Lupin's Ankleshwar facility won the Platinum Award for 7ACCA yield improvement project at 15th CII Six Sigma National Competition India Pharma Awards 2021 21#22THANK YOU LUPIN Registered Office Lupin Limited, 3rd Floor, Kalpataru Inspire, Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India. Phone: +91 22 6640 2323 | Fax: +91 22 6640 2051 | www.lupin.com in lupin LupinGlobal Lupin Global Lupin World Lupin Global

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