Lupin Limited · NSE:LUPIN
Lupin — Investor Presentation (May 2019)
36 slides from Lupin's investor presentation, May 15, 2019
Slide 1: Covering letter to BSE and NSE
May 15,2019 BSE limited Deportment of Corporate Services. P. J. Towers. Dalal Street. MU BAI - 400 001 . ational Stock Exchange of India limited Exchange Plaza. Sondra Kurio Complex. Sondra (East). Mumbai - 400 051. Dear Sirs, Sub: Annual Investors Communication. Pursuant to Regulation 30(2) read wi
Slide 2: Lupin Limited Annual Investor Meet
LUPIN LIMITED Annual Investor Meet May 15, 2019
Slide 3: Safe Harbor Statement
Safe Harbor Statement 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 diffe
Slide 4: Agenda
Agenda • Industry Trends • Progress on Strategic Growth Drivers • Business Performance • Cost Optimization Roadmap • Regulatory Update • Priorities for FY20 3
Slide 5: Industry Trends
BGHi. 4 LUPIN Industry Trends
Slide 6: US generics: Emerging Signs of Stabilization
US generics Emerging Signs of Stabilization Slowing ANDA submissions1 Discontinuations by generic majors2 Stabilizing pricing environment3 No of Drug Discontinuations (US) Price change (%) YoY in US 64 generics 15% 28 27 (5%) 1,128 1,042 1,019 13 676 10 3 2 3 (12%) Jul-16 May-17 Mar-18 Oct-17 Nov-14
Slide 7: US generics: Emerging Signs of Stabilization
US generics Emerging Signs of Stabilization US generic market stabilizing Substantial opportunities exist Indian companies gain TRx share3 US Generics Market Size1 (US$ bn) US Small molecule brand LOE2 (US$ bn) ~45% 28 79 83 86 77 71 73 69 19 18 13 12 2016 2017 2018E 2019E 2020E 2021E 2022E 2019E 20
Slide 8: India Pharma Market (IPM)
India Pharma Market (IPM) Structural growth story intact IPM growth components1 Chronic therapies outpacing acute1 IPM to Sustain growth of 10% 15% 3 yr. CAGR India Pharma Market2 (INR bn) Anti Diabetic 15% 4% Respiratory 13% 1,617 Chronic 11% 1,472 10% Cardiac 9% 1,337 6% 3% Neuro / CNS 8% 1,212 5%
Slide 9: Other pharma market trends
Other pharma market trends Japan Pharma Market – by Value1 (US$ bn) Modest growth seen across other key pharma markets 79 73 80 76 76 1% 0% 0% -2% 0% 5% 5% 4% 3% 6% 7% 2% 5% 6% 92% 91% 90% 89% 93% Pharma market size1 (US$ bn) 10% CAGR: 2014-2018 7% 8% 9% 11% CAGR*: 2018-2023E3 2014 2015 2016 2017 20
Slide 10: Complex generics: Sizeable opportunities in the US
Complex generics Sizeable opportunities in the US Dollar share1 of Non Oral Solids increasing Lower pricing pressures seen in complex generics2 US$ bn 335 476 30% Generic Y/Y Pricing Change 36 37 20% 9 14 30 10 11 20 10% 97 178 0% 167 201 (10%) (20%) Oct-14 Apr-15 Oct-15 Apr-16 Oct-16 Apr-17 Oct-17
Slide 11: Biosimilars: Market opening up
Biosimilars Market opening up Biologics Represents a US$230 bn Global market1 with 8 …and will continue to be the Fastest Growing Segment out of the Top 10 Best-selling Drugs being Biologics… (US$bn) 19% 26% 31% CAGR1 20.5 Top 10 Best-selling Drugs (US$ bn) 1,500 1,249 2012-18 2018-24E 1,000 757 868
Slide 12: Specialty: Women's Health and CNS
Specialty Women’s Health and CNS Women’s Health represents large market with areas of unmet needs US Women’s Health market by therapies2 Commentary 12 13 13 13 13 14 15 11 11 11 12 12 Large market worldwide and growing steadily – US market estimated at about ~US$ 12 bn – Global market at US$ 31- 35
Slide 13: Progress on Strategic Growth Drivers
Progress on Strategic Growth Drivers
Slide 14: Strategic Vision
Strategic Vision Well Diversified Pharma Business Strong Complex Specialty Foundation Generics Focus Focus Amongst the Top 10 Focus on delivering high Committed to building a generic companies in the barrier products strong specialty business World Sustain and Grow Portfolio Execution Build • Major
Slide 15: Lupin Today
Lupin Today Leading global pharmaceutical player Leadership in Global Generics with a diversified geographical footprint and manufacturing base Globally Major Markets Key Metrics Market Cap (3) INR 365 bn 8th 3rd 3rd 5th 6th Revenue (FY19) INR 164 bn Largest generic Largest Indian Largest in the Ind
Slide 16: Complex Generics & Biosimilars Pipeline Progress
Complex Generics & Biosimilars Pipeline Progress Target Market Product No. of Pipeline Progress Size1 (US$ bn) segment Products o First MDI & DPI filed with more under development o Albuterol MDI (gProAir) filing under FDA review – H2 FY20 launch 18 Inhalation 13 o Tiotropium DPI (gSpiriva) filed, F
Slide 17: U.S. Specialty: Building a Leading Women Health business
U.S. Specialty Building a Leading Women Health business Single Dose 93% 133 Total Payor Coverage Dedicated WH reps Treatment for BV Focus to add more WH assets 10 Years 70% 7 years Unrestricted Coverage Average WH exp Data exclusivity Managed Care Specialized Sales Unique Positioning access force Bu
Slide 18: Specialty update (Ex-US)
Specialty update (Ex-US) CNS focus Orphan Drug +181% YoY FY19 sales 66 MR’s Launched Co-promotion Directly engaged Via own front end Partnering agreement with Yoshitomi discussions ongoing (170+ MRs) 17
Slide 19: Business Performance
Seiten + LUPIN Business Performance
Slide 20: Q4 FY19 Snapshot
Q4 FY19 Snapshot Sales (INR mn, YoY growth) Important developments India, Commercial 10,525 , 9% North America, • 8 new product launches incl. exclusive gRanexa, gSolodyn launches 17,406 , 16% Total • Higher gTamiflu sales due to seasonality 43,259, 9% • Monetization of Complex Generics underway wit
Slide 21: FY19 Snapshot
FY19 Snapshot Sales (INR mn, YoY growth) Important developments Commercial India, North America, 46,382 , 12% 55,924 , (5%) • Monetization of Complex Generics underway Total • Successfully launched Solosec on the Specialty front 163,694, 5% • Expanded partnership with BI and Lilly for 3 anti-diabeti
Slide 22: North America
North America 34% YoY Q4FY19 QoQ Back to Growth 16.1% 22.8% US revenues getting back on growth mode Solosec monthly TRx ramp up 7,189 5,626 33% average 5,114 5,354 market share1 3,993 2,739 2,577 2,954 1,807 Lupin consolidating its position in US1 629 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18 Nov-18 Dec-18
Slide 23: India
Q4FY19 India 29% YoY QoQ Consistently outperforming market 9.1% 11.6% Healthy YoY growth Continue to outpace industry growth India quarterly Sales (INR bn) YoY Growth (%) CAGR FY15-191 Lupin Rank1 11.9 12.0 11.9 12.4 MAT MAT Therapy Market Lupin 10.5 10.5 Dec-15 Dec-19 Acute 9% 8% 14 12 Chronic 12%
Slide 24: Japan
Q4FY19 Japan 13% YoY 8.6% QoQ 4.0% Pricing regulation changes hurt Japan pharma growth Japan sales evolution (INR bn) Japan Generics Market1 (US$ bn) 7.7 8.3 7.2 5.4 5.9 5 5.0 5.1 5.7 5.5 2013 2014 2015 2016 2017 2018 Q1 FY19 Q2 FY19 Q3 FY19 Q4 FY19 Japan Generics Market Update Performance highlight
Slide 25: Other markets
Other markets • Germany: EUR 7.1 mn sales in Q4FY19; EUR 28.7 mn sales in FY19 Developed EU5 • ARV’s, Women´s Health and CNS are the key focus therapeutic segments • NaMusclaTM - Launched with Orphan drug designation in UK, Germany and France Australia • 5th largest Gx player1; FY19 revenues up 7.4%
Slide 26: R&D spend optimized
R&D spend optimized Higher focus on complex products and FTFs Invested INR 15.7 bn or 9.6% of sales on R&D in FY19 at 9 R&D sites globally Optimizing R&D spend (INR bn) Filings and Approvals (US) US Pipeline 11.9% 9.6% 5.0 9.9% 20.0 12 422 cumulative filings 9.7% 9.7% 10.0% 11 4.5 9.2%18.0 4.0 16.0
Slide 27: P&L Highlights – Q4 FY19
P&L Highlights – Q4 FY19 QoQ QoQ QoQ YoY Amount in INR mn Q1 FY19 Q2 FY19 Q3 FY19 Q4 FY19 Q4 FY18 Growth Growth Growth Growth Net sales 37,746 38,909 3.1% 43,779 12.5% 43,259 (1.2%) 39,785 8.7% Other operating income 814 601 1,269 804 553 Total revenue 38,560 39,510 45,048 44,063 40,338 9.2% Gross P
Slide 28: P&L Highlights – FY19
P&L Highlights – FY19 Amount in INR mn FY19 % of sales FY18 % of sales YoY growth Net sales 163,694 100.0% 155,598 100.0% 5.2% Other operating income 3,488 2,443 Total revenue 167,182 158,041 5.8% Gross Profit 105,236 64.3% 102,854 66.1% 2.3% (excl. other operating income) EBITDA 32,462 19.8% 32,979
Slide 29: EBITDA evolution
EBITDA evolution INR mn Q4 FY19 Q3 FY19 Q2 FY19 22% 9,588 Q1 FY19 18% 7,960 20% 7,803 18% 7,112 Gross R&D Other EBITDA Gross R&D Other EBITDA Gross R&D Other EBITDA Gross R&D Other EBITDA Profit Exp* Profit Exp* Profit Exp* Profit Exp* Note: * - Other exp. is net of other income 28
Slide 30: Cost Optimization Roadmap
Cost Optimization Roadmap
Slide 31: Focus on Cost Optimization
Focus on Cost Optimization Key execution tracks to improve profitability Align organization structure to future Organization strategic direction ▪ Sharp focus on US and India ▪ Improve R&D productivity Strategic ▪ Build agility in supply ▪ Procurement efficiencies chain ▪ Throughput Operational impr
Slide 32: Regulatory Update
BGHi. 4 LUPIN Regulatory Update
Slide 33: US Regulatory update
US Regulatory update WL issued to Goa and Pithampur (Unit 2) Mandideep Unit 1 received 18 ‘483’s; Unit 2 issued 4 ‘483’s post inspection Nov Monthly WL updates to Nagpur facility Somerset facility issued 6 ‘483’s Pithampur (Unit 2) retained OAI status 2017 USFDA through Jul 2018 inspected with 0 ‘48
Slide 34: Priorities for FY20
BGHi. 4 LUPIN Priorities for FY20
Slide 35: Near term priorities
Near term priorities • Focus on productivity • Ensure regulatory compliance – • Deliver on identified cost Warning letter & OAI saving measures Strong resolution Cost • Sharp focus on resource Generics • Execute on Levothyroxine and Optimization Foundation 20+ planned launches in the US allocation •
Slide 36: Thank You
. YEARS OF LUPIN a LUPIN THANK YOU