Oxford Immunotec Company Overview

Transcription

1 Oxfrd Immuntec Cmpany Overview J.P. Mrgan Healthcare Cnference 2019 Oxfrd Immuntec Glbal PLC 94C Innvatin Drive Miltn Park, Abingdn Oxfrdshire, OX14 4RZ, United Kingdm Cmpany Number

2 Frward-Lking Statements Certain infrmatin cntained in this presentatin cnstitutes frward-lking statements, including thse related t anticipated plans and bjectives, future perfrmance and revenues, financial cnditin, prspects, grwth, strategies, expectatins and bjectives f management. Frward-lking statements can be identified by the fact that they d nt relate strictly t histrical r current facts. The financial results and frward-lking statements cntained in this presentatin reflect ur current expectatins and are subject t risks and uncertainties. Actual results may differ materially frm thse prjected r implied by frward-lking statements. Please review ur SEC filings fr mre infrmatin regarding thse factrs that culd cause actual results and events t differ materially frm thse indicated in the frward-lking statements. Our filings are available fr free by visiting the investr sectin f ur website, r the SEC's website, Investrs shuld give careful cnsideratin t these risks and uncertainties. Frward-lking statements cntained herein are based n current expectatins and assumptins and currently available data and are neither predictins nr guarantees f future events r perfrmance. Yu shuld nt place undue reliance n frward-lking statements cntained herein, which speak nly as f the date f this release. We d nt undertake t update r revise any frwardlking statements after they are made, whether as a result f new infrmatin, future events, r therwise, except as required by applicable law. T-SPOT, T-Cell Select, T-Cell Xtend, and the Oxfrd Immuntec lg are trademarks f Oxfrd Immuntec Ltd. 2

3 Glbal, High-Grwth Diagnstics Cmpany Fcused n prprietary assays fr immunlgy and infectius disease Bstn, MA US headquarters US cmmercial peratins US supply chain peratins Oxfrd, UK OUS headquarters OUS cmmercial peratins Manufacturing Prduct develpment UK ODL lab 3 Shanghai, China China market develpment ffice Medical educatin, marketing, technical supprt Ykhama, Japan Japan headquarters Japan cmmercial peratins

4 A Fundamentally Transfrmed Cmpany Divestiture f US service business t Quest Diagnstics fr $170M repsitins cmpany Grwth Fcus Prfitability Optinality Explit the large, grwing and underserved market fr Tuberculsis (TB) screening Dramatically simplified peratins as a pure-play prducts cmpany fcused n TB Materially imprved tp- and bttm- line prfitability Markedly strnger balance sheet 4

5 Tuberculsis: The Wrld s Deadliest Infectin 10,000,000 new cases 1,600,000 deaths Tp 10 cause f death glbally Leading cause f death wrldwide frm a single infectius agent Surce: Glbal Tuberculsis Reprt Geneva: Wrld Health Organizatin (WHO);

6 Reactivatin Tuberculsis Cntrl Relies n Screening fr Latent TB Ending the tuberculsis epidemic will require the eliminatin f this [reservir] f infectin - Wrld Health Organizatin, The End TB Strategy 1.7 billin peple are estimated t have a latent TB infectin Individuals with Latent TB infectin are at risk f develping active TB disease during their lifetime Reinfectin Screening fr TB infectin is a critical element f TB cntrl Prevents future cases prevents future transmissin Surces: Glbal Tuberculsis Reprt Geneva: WHO; The End TB Strategy. Geneva: WHO;

7 TB Screening: A Majr Glbal Market Opprtunity 50M+ Latent TB Infectin (LTBI) screening tests perfrmed each year UN set aggressive gal fr rapid scale up f testing, t get >30 millin peple n preventative treatment by 2022 Surces: Diagnstics fr Tuberculsis: Glbal Demand and Market Ptential. Geneva: WHO; General Assembly reslutin 73/3, Plitical declaratin f the high-level meeting f the General Assembly n the fight against tuberculsis, A/RES/73/3 (10 Octber 2018), available frm undcs.rg/a/res/73/3. 7

8 The Current Screening Test fr TB Tuberculin Skin Test ( TST ) This methd has been in clinical use fr mre than 90 years. Unfrtunately, its applicatin is prblematic due t the frequency f false-psitive and false-negative skin reactins. - Wrld Health Organizatin, Diagnstics fr Tuberculsis Main Limitatins Lw sensitivity, especially in immunsuppressed, newbrns, and elderly Pr specificity due t: Prir BCG vaccinatin Envirnmental mycbacteria Requires a return visit fr reading Inculatin and reading are technique-dependent and require specially-trained peratrs Recurrent supply shrtages f purified prtein derivative (PPD), the test substance used Cllectively these issues result in inefficient use f healthcare resurces Surce: Diagnstics fr Tuberculsis: Glbal Demand and Market Ptential. Geneva: WHO;

9 Market Replacing TST with IGRA Bld Tests Our slutin: T-SPOT.TB Bld test based n immunlgy; generically referred t as an interfern-gamma release assay One f tw recmmended alternatives t TST Superir sensitivity cited in recent guideline updates and publicatins IGRAs have several advantages ver the TST Higher specificity (fewer false psitives) N need fr specifically trained healthcare wrkers N need fr return visit Surces: Glbal Tuberculsis Reprt Geneva: Wrld Health Organizatin (WHO); Lewinshn DM, Lenard MK, LBue PA, Chn DL, Daley CL, et al. Official American Thracic Sciety/Infectius Diseases Sciety f America/Centers fr Disease Cntrl and Preventin Clinical Practice Guidelines: Diagnsis f Tuberculsis in Adults and Children. Clinical Infectius Diseases

10 Significant Cmmercial T-SPOT.TB Adptin CE mark (EU apprval), 1 st EU guideline, US FDA apprval 2010 CDC guidelines issued in US; Chinese SFDA apprval 2011 CPT cde & US Medicare reimbursement established Japanese MHLW apprval & reimbursement established SWITCH health ecnmic study published in US T-SPOT.TB apprved fr sale in >50 cuntries Revised Japanese guidelines 2014 Opened market develpment ffice in China; hired salesfrce in Japan 2015 Exceeded 300m cvered lives in the US UK NHS Tender fr new entrant screening USPTF Grade B recmmendatin & revised ATS/IDSA/CDC guidelines New screening guidelines in Suth Krea & expanded guidelines in China French reimbursement CDC decisin requiring use f IGRA & new WHO latent TB guidelines IGRAs included in first-ever WHO Essential Diagnstics List AAP recmmends use f IGRAs in children as yung as tw years ld 2019 CMS expands reimbursement premium ver cmpetitive IGRA further Surce: Oxfrd Immuntec cmpany reprts 10

11 Yet, Adptin is Still Early Ptential market pprtunity exceeds: TST ~75-80% Market Share IGRAs ~20-25% Market Share Surce: Oxfrd Immuntec analysis 50M+ tests annually Guidelines becming ever mre supprtive f cnversin 11 AAP guidelines n LTBI screening, June 2018 IGRAs t be used even in children as yung as 2 years ld WHO Essential Diagnstics List, May 2018 WHO latent TB guidelines, February 2018 Remve prir recmmendatin against IGRA use in lw and middle incme cuntries CDC instructin t civil surgens, February 2018 TST is n lnger acceptable, must perfrm an IGRA CDC/ATS/IDSA guidelines, December 2016 IGRAs preferred ver TST T-SPOT.TB has superir sensitivity

12 US: The Largest Single Market fr LTBI Screening Principal Screened Ppulatins US Market by Segment Market Segment by Testing Lcatin Segment Size (Tests/Year) Hspitals 7.0M Public & Student Health 1.5M Physicians Offices/Clinics 7.3M Other 1 6.0M TOTAL ~22M Surce: Oxfrd Immuntec analysis 1 Military, Crrectinal Facilities, Chrnic Care Hmes, and Other 12

13 Quest Deal Bradens US Market Access fr T-SPOT.TB By leveraging Quest s reach and capabilities, US market access t T-SPOT.TB will be immediately bradened: Enables unparalleled access t the large physician ffice market segment Helps remve barriers t adptin Gaining an additinal vice in the market 13

14 Outside the US: Grwing Demand fr TB Screening Already strng uptake f IGRAs in develped markets We have a strng business in Eurpe and in Japan where we are the market leader Grwing market as cuntries expand TB screening Significant new prgrams ver past years in UK, Krea, China 2018 WHO latent TB guidelines: prvides mre ptins fr the testing and evaluatin f at-risk ppulatins UN declaratin t get >30 millin peple n TB preventative treatment by 2022 Expand gegraphical channel t meet the demand Grwing presence in Asia, evaluating additinal cuntries & partnerships Surces: WHO; Oxfrd Immuntec estimates Surces: Latent Tuberculsis Infectin: Updated and Cnslidated Guidelines fr Prgrammatic Management. Geneva: WHO; General Assembly reslutin 73/3, Plitical declaratin f the high-level meeting f the General Assembly n the fight against tuberculsis, A/RES/73/3 (10 Octber 2018), available frm undcs.rg/a/res/73/3. 14

15 T-Cell Select: Fully Autmated Slutin & 54-Hur Strage T-Cell Select enables full autmatin f T-SPOT.TB, prviding unrivaled sample stability and simplicity f bld cllectin 54-hur strage at rm temperature Sample Stability Benefits: Lngest sample stability Mst flexible lgistics Expands labratry reach Enables sample batching Autmatin Benefits: Simplifies wrkflw Reduced hands-n time Decreases labr csts Imprves thrughput 15 Surce: Oxfrd Immuntec

16 Our Lnger-Term Strategic Optinality TB Acquire prducts/cmpanies in the TB space t leverage and expand ur cmpetitive psitin Immunlgy Explit ur immunlgy knwhw and inventins in ther markets, acquire cmpanies with cmplementary prducts & channel OXFD tday Channel Leverage ur glbal manufacturing, regulatry and cmmercial channel thrugh acquisitin f entities that can benefit frm this 16

17 Financial Prfile Strng mmentum in TB business Recurring revenue allws us t fcus sales teams primarily n driving grwth Recrd vlumes in Q Brad-based grwth acrss US, Asia, and Eurpe & ROW Significantly enhanced grss margin prfile ~70% grss margins Imprved bttm-line prfitability prfile Reduced OPEX spend as a pure-play prducts cmpany, cmbined with expanded grss margins 1 Pre-Transactin: ttal cmpany grss margins, as reprted fr the year ended Dec 31, 2017 Pst-Transactin: expectatins fr ttal cmpany grss margins fllwing the clse f transactin, as cmmunicated n the 3Q18 earnings call Strng balance sheet ~$200M in cash and n debt, fllwing clse f Quest transactin in Nvember

18 Key Pririties fr 2019 Grwth & Fcus Prfitability Accelerate revenue grwth thrugh strategic cllabratin with Quest Diagnstics, which significantly increases the reach and cmpetitiveness f T-SPOT.TB in the largest market fr TB screening (the US) Grw cmmercial channels utside the US as mre cuntries cmmence and expand TB screening prgrams and t meet rising demand Imprve ur custmer experience thrugh cntinued investment t pull thrugh the benefits f T-Cell Select Cntinued investment in autmatin f ur TB kit manufacturing t reduce COGS Drive perating leverage thrugh dramatically simplified peratins as a pure-play prducts cmpany with ~70% grss margins Optinality Return cash t sharehlders via a $100 millin share purchase prgram 1 1 The share purchase prgram apprved by the Bard f Directrs is subject t sharehlder apprval and will be presented fr sharehlder apprval n r befre the cmpany's annual general meeting f sharehlders n Tuesday, June 18,

19 Summary & Key Investment Highlights Leadership psitin in new class f testing fr wrld s deadliest infectius disease Very large, grwing, underserved market Differentiated, industry-leading immunlgy technlgy Diversified, recurring revenue streams Strng revenue grwth Strng grss margins Pathway t prfitability thrugh expense leverage Strng balance sheet Brad pprtunities t build value in the business 19