Slide 1: Seqirus Presentation to Investors/Analysts
For personal use only 14 March 2016 Australian Securities Exchange Seqirus Presentation to Investors/Analysts Please see attached presentation to investors/analysts given by: • Gordon Naylor, President, Seqirus • Russell Basser, SVP R&D, Seqirus • Brent MacGregor, SVP Commercial Operations, Seqirus
Slide 2: Investor / Analyst Site Tour, Liverpool
For personal use only INVESTOR / ANALYST SITE TOUR 11th March 2016 LIVERPOOL
Slide 3: Legal Notice
Legal Notice For personal use only Forward looking statements The materials in this presentation speak only as of the date of these materials, and include forward looking statements about CSL Limited and its related bodies corporate including Seqirus (CSL) financial results and estimates, business p
Slide 4: Introduction
For personal use only INTRODUCTION Gordon Naylor, President
Slide 5: The global burden of seasonal influenza remains high
The global burden of seasonal influenza remains high Each year, influenza related For personal use only illness: Northern • Attacks 5%–10% of adults and hemisphere 20-30% of children globally1 Influenza peak: • Causes 3 million – 5 million November–March cases of severe illness1 • Causes up to 500,0
Slide 6: Industry Overview
Industry Overview • ~$6b global market including pre- For personal use only pandemic Commodity Seasonal • Seasonal market growing at low (~$4b) single-digits pa Premium • Distinct but related segments, with different competitive and growth characteristics Reservation fees Pre- Pandemic (<$2b) Pre-pa
Slide 7: Seqirus Today
Seqirus Today CORPORATE FUNCTION OPERATIONAL BUSINESSES GLOBAL For personal use only • Influenza CSL R&D AUSTRALIA/NZ • In-licensing • Contract logistics • Immunohaematology • Products of national significance: Q-fever vaccine and anti-venoms 6
Slide 8: Seqirus Manufacturing Sites & Commercial presence
Seqirus Manufacturing Sites & Commercial presence Highlights ~1900 employees World’s no. 2 influenza vaccine For personal use only Capacity Northern Hemisphere ~130mds*(projected QIV) provider in sales with operations in *Assumption is QIV, ~34 weeks of NH campaign (@ 7 day / week operation) mor
Slide 9: Leadership Team
Leadership Team For personal use only President GORDON NAYLOR SVP Commercial Operations SVP Business VP Human BRENT Services SVP Operations Resources MACGREGOR KEN LIM STEVE MARLOW TANYA KENNEDY SVP R&D VP Quality VP Finance Global Head Legal RUSSELL BASSER VAS MAVROGENIS HELEN GEARING JOHN MINARDO
Slide 10: Integration & Turnaround Update
Integration & Turnaround Update For personal use only • Acquisition was a carve out from a carve out • Integration progressing well: Novartis - Transaction closed on 31 July 2015 (NVS) NVS Vaccines (sold to GSK) - Combined leadership team and organisation re-design NVS Flu - New global headquarters
Slide 11: Success Plan
Success Plan For personal use only • Remaining elements of organisational design Complete integration • IT Improved focus / • COGS, speed to market, quality, customers, efficiency Government • Reduction in spend as complete clinical Step down in R&D development programs • Bring pipeline to market La
Slide 12: Seqirus Research & Development
For personal use only SEQIRUS RESEARCH & DEVELOPMENT Russell Basser, SVP R&D
Slide 13: Seqirus Influenza Vaccine Platform
Seqirus Influenza Vaccine Platform For personal use only High-risk Standard risk populations Seasonal Adjuvanted Seasonal Pandemic Egg based Cell culture Influenza Science 12
Slide 14: The difference between epidemic vs pandemic influenza
The difference between epidemic vs pandemic influenza For personal use only ANTIGENIC DRIFT ANTIGENIC SHIFT Small mutations New strain Epidemic Pandemic (yearly) (occasionally) May vary season to season SH vs NH 13
Slide 15: Identification and preparation of seasonal influenza vaccine strains (1)
Identification and preparation of seasonal influenza vaccine strains (1) For personal use only Flu surveillance WHO Collaborating Seqirus WHO Strain isolated Centre & typed Antigenic & WHO National genetic New Influenza Centres analysis Strain WHO Reassort virus Collaborating → seed Centre Strain se
Slide 16: Identification and preparation of seasonal influenza vaccine strains (2)
Identification and preparation of seasonal influenza vaccine strains (2) Adaptation of virus for growth in eggs (reassortment) For personal use only Seasonal strain Selection based on seasonal HA and NA high growth properties High growth donor strain 15
Slide 17: The difference between Trivalent (TIV) & Quadrivalent (QIV) Influenza Vaccine
The difference between Trivalent (TIV) & Quadrivalent (QIV) Influenza Vaccine For personal use only Trivalent vaccine = two A strains + “dominant” B strain Quadrivalent vaccine = two A strains + two B strains WHO Influenza Collaborating Centres • select strains for vaccine twice per year – SH (Sept)
Slide 18: Egg vs cell culture manufacturing of influenza vaccine
Egg vs cell culture manufacturing of influenza vaccine For personal use only EGG-DERIVED • Process well established & understood Virus Filling, • Long track record of safety & Seed Virus harvested, Further strains propagation in concentrated purification final efficacy embryonated testing and select
Slide 19: Benefits of MF59 Adjuvant in seasonal and pandemic influenza vaccines
Benefits of MF59 Adjuvant in seasonal and pandemic influenza vaccines For personal use only FLUAD™ MF59 Improved efficacy Antigen Sparing Cross-reactivity Pediatrics - efficacy 86% vs 43% non-adj.1 Improved breadth of immune Especially pandemic vaccine Elderly - ↓ hospitalization by 25%2 response Ex
Slide 20: Key R&D Influenza Vaccine Programs
Key R&D Influenza Vaccine Programs Currently approved for 18+ yrs in US TIV Paediatric (4+yrs) under review For personal use only 4+ under review in US Link to QIV program Cell culture QIV Under review in US Target 4+ years Long standing approval in EU TIV Approved Approved 6M-2 yrs, 65+ yrs Canada
Slide 21: Why Adjuvanted Vaccines
Why Adjuvanted Vaccines Targeting age groups at high risk For personal use only Age-related hospitalizations and TIV efficacy rates 100 Vaccine (TIV) efficacy1-3 Hospitalization rate4 70 60 80 Influenza-related hospitalization rate 50 (events per 100,000) Vaccine efficacy (%) 60 40 30 40 20 20 10 0
Slide 22: Future directions for influenza vaccine innovation
Future directions for influenza vaccine innovation For personal use only Alternate routes of delivery Novel sources of antigens Universal vaccine 21
Slide 23: Universal flu vaccine - target conserved parts of virus
Universal flu vaccine - target conserved parts of virus Goal to find ‘Achilles heel/s’ present in all flu viruses For personal use only Hemagglutinin Broadly Neutralizing Antibodies (main vaccine component) To Conserved Regions Variable RAISE Seasonal Epitopes BROADLY NEUTRALISING Conserved ANTIBODI
Slide 24: Seqirus Commercial
For personal use only SEQIRUS COMMERCIAL Brent MacGregor, SVP Commercial Operations
Slide 25: Influenza causes significant hospitalizations each year
Influenza causes significant hospitalizations each year For personal use only 24
Slide 26: In the US there has been modest growth of vaccination rates
In the US there has been modest growth of vaccination rates despite 2010 universal recommendation For personal use only 100 90 80 70 60 50 46.2 46.2 47.1 45 43 41.8 40 30 20 10 0 2009-10 2010-11 2011-12 2012-13 2013-14 2014-15 Source: National Immunization Survey-Flu (NIS-Flu) and Behavioral Risk Fa
Slide 27: Our commercial focus around five key drivers of growth
Our commercial focus for the coming years will be around five key drivers of growth For personal use only 1 Launch Fluad 65+ in the US market in the elderly segment first, followed by the pediatric segment 2 Maintain our TIV offer in the near-term while launching our QIV offer 3 Grow our Rapivab bus
Slide 28: Seqirus provides a differentiated portfolio of vaccines and treatment for influenza
Seqirus provides a differentiated portfolio of vaccines and treatment for influenza that we will continue to improve Age Indication Planned Future For personal use only Brand Target Offer Today Age Indication 6 mths-6 years 65+ years QIV 65+years 18+ years 4+ years QIV 18+ years 6mths+ QIV 18+ years
Slide 29: Our product strategy: adjuvanted QIV and egg or cell-based QIV
Our product strategy: adjuvanted QIV product in Pediatric and Elderly and egg or cell-based QIV for the general population For personal use only Fluad Pediatric (aQIV) Expected greater efficacy in vulnerable 6m - 6y populations compared to non-adjuvanted influenza vaccines Fluad (aQIV) 65y+ Afluria
Slide 30: US and European markets transitioning to QIV more slowly than expected
While the US and European markets are transitioning to QIV, this transition has taken longer than originally expected For personal use only 80% 2013 Seqirus projections of 70% TIV market decline versus actual decline for the US 60% 50% 40% 30% 20% 10% 0% 2013-14 2014-15 2015-16 Projections TIV Actua
Slide 31: Rapivab is an effective complement to our Flu vaccines portfolio
Rapivab™ (peramivir injection) is an effective complement to our Flu vaccines portfolio For personal use only • Approved in the US Dec 2014 • Niche indication for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 48 hrs • Single,
Slide 32: In pandemic preparedness, Seqirus is a leading global player
In pandemic preparedness, Seqirus is a leading global player with a strong track record Leading pandemic assets and capabilities For personal use only Production capabilities with global manufacturing network with different technologies. Holly Springs specifically designed for rapid scale-up of prod
Slide 33: In Australia and NZ, Seqirus augments its core flu vaccine with in-licensed portfolio
In Australia and NZ, Seqirus augments its core flu vaccine with a comprehensive In-Licensed Vaccine & Pharmaceutical Portfolio For personal use only Vaccine Partners Products Pharma Partners Products Gardasil, RotaTeq, Palexia Varivax, Vaqta, Tramal Pain Pneumovax23, Caldolor Zostavax, MMRII, Versat
Slide 34: In Summary
For personal use only IN SUMMARY Gordon Naylor
Slide 35: On track to meet our growth targets over the next few years
On track to meet our growth targets over the next few years For personal use only • Integration is going well • Fluad will drive a material increase in defensible value in our primary market • Migration to QIV in key markets will increase value per dose across much of the sales volume Holly Springs