Oxfrd Immuntec Cmpany Overview Nvember, 2015 Dr. Peter Wrightn-Smith, Chief Executive Officer Rick Altieri, Chief Financial Officer Oxfrd Immuntec Glbal PLC 94C Innvatin Drive Miltn Park, Abingdn Oxfrdshire, OX14 4RZ, United Kingdm Cmpany Number 08654254 www.xfrdimmuntec.cm 1
Frward-lking Statements Certain infrmatin cntained in this presentatin cnstitutes frward-lking statements, including thse related t 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 preliminary financial results and frward-lking statements cntained in this presentatin reflect ur current expectatin 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 EDGAR n the SEC Web site at www.sec.gv. Frward-lking statements 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, which speak nly as f the date f this presentatin. We d nt undertake t update r revise any frward-lking statements after they are made, whether as a result f new infrmatin, future events, r therwise, except as required by applicable law. 2
Cmpany Prfile We are a glbal cmmercial-stage diagnstics cmpany Memphis, TN ODL CLIA lab LDT develpment Manufacturing Marlbrugh, MA US Headquarters US cmmercial peratins Oxfrd, UK OUS Headquarters OUS cmmercial peratins Manufacturing Prduct develpment 3 UK ODL Lab Shanghai, China China market develpment ffice Medical Educatin, Marketing, Technical supprt Ykahama, Japan Japan Headquarters Japan cmmercial peratins
Cmpany Visin T becme a leading diagnstics cmpany, fcused n develping and cmmercializing prprietary tests fr the management f immune-regulated cnditins 4
Immune-regulated Cnditins Chrnic infectins Transplantatin Autimmune / inflammatry Immune nclgy Diagnstic unmet needs: Diagnstic unmet needs: Diagnstic unmet needs: Diagnstic unmet needs: Tls t better diagnse, r indicate risk f disease frm chrnic infectins Tls t guide immunsuppressive therapy selectin Tls t predict rejectin Tls t aid mre accurate diagnsis Tls t guide therapy selectin Tls t guide disease prgnsis Standardised tls t measure treatment efficacy and/r immune status preand pst- therapy 5
Prducts & Pipeline Prduct Name T-SPOT.TB TB Indicatin Cncept Feasibility Analytical Validatin Clinical Validatin T-SPOT.CMV T-SPOT.PRT SpirFind GutiFind T-SPOT.ICA B cell assay Stratkine I-O mnitring CMV Organ rejectin Lyme disease Gut Immune cmpetence Organ rejectin Autimmune disease Immune nclgy Cmmercial Launch 6
Tuberculsis Glbal Emergency T treat TB, we have t catch it early, ideally befre infectin turns t disease (TB screening) ~2 billin peple infected wrldwide, each with a 10% chance f develping active TB ~9 millin peple gt active TB in 2013 and ~1.5 millin died N cuntry has been able t eliminate TB Cnstant effrts are required t cntrl it There is n effective vaccine fr TB, therefre, we have t diagnse and treat It is a leading cause f preventable infectius disease death Reactivatin Reinfectin Surce: WHO, CDC, US Institute f Medicine 7
TB Diagnstic Markets TB Screening Detect asymptmatic (latent) TB infectin in high risk grups Give infected individuals prphylactic treatment t cure the infectin, thereby reducing their chance f develping TB and transmitting it t thers TB Diagnsis Cnfirm active TB disease in symptmatic patients Respnse t TB Outbreak in Suth Carlina Raises Questins Wrker in Maternity Ward f Manhattan Hspital Tests Psitive fr TB Wrker s TB Investigated at Hspital Tuberculsis deaths at Las Vegas hspital's NICU spur health alert 700 infants expsed, 8 test psitive fr TB at Texas hspital July 2013 Oct. 2013 Oct. 2013 Oct. 2013 Sept. 2014 Surce: Centers fr Disease Cntrl and Preventin. Targeted tuberculin testing and treatment f latent tuberculsis infectin. MMWR 2000;49(N. RR-6) 8
Detecting TB Infectin A majr glbal market pprtunity ~50M Latent TB Infectin (LTBI) screening tests perfrmed each year 1 >$1BN estimated market pprtunity 2 Increased emphasis n LTBI testing by WHO 3 1 Diagnstics fr Tuberculsis: Glbal Demand and Market Ptential. WHO 2006 2 Cmpany estimates based n current ASP and business mdel 3 Guidelines n the management f latent tuberculsis infectin. WHO 2015 9
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 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 Cllectively these issues result in inefficient use f healthcare resurces Surce: WHO. Diagnstics fr Tuberculsis 2006 10
Market Replacing TST with IGRA Bld Tests Market adpting bld tests called interfern-gamma release assays (IGRAs) Measure increased IFN-secretin by T cells previusly expsed t M. tuberculsis Use purified M. tuberculsis-specific antigens, such as ESAT-6 & CFP10 IGRAs have several advantages ver the TST Higher specificity (fewer false psitives) N need fr specifically trained healthcare wrkers N need fr return visit IGRAs nw included in clinical guidelines fr TB screening frm multiple cuntries, including the US, Eurpe and Japan 11
IGRA Players QuantiFERON TB Gld In-Tube Nte: Qiagen acquired this prduct thrugh the acquisitin f Cellestis fr $374M in 2011 QuantiFERON is a registered trademark f Qiagen NV 12
Glbal Regulatry Apprvals T-SPOT.TB apprved in >50 cuntries 2004: Eurpean apprval (CE mark) 2005: Canadian apprval 2009: Taiwan apprval 2010: Chinese SFDA apprval 2006: Krean apprval 2008: US FDA (PMA) apprval 2012: Russian apprval 2012: Japanese apprval 13
Well Validated Test Perfrmance ~400 published studies n T-SPOT.TB test 14 Surce: PUBMED. Accessed July 23rd 2013, updated Feb 24th 2014, 2nd Jan 2015
Reimbursement Established Strng health ecnmic case Inclusin in frmal clinical lab fee schedules, e.g. US: Unique CPT cde 86481, CMS $102/test Germany: 68.40 ($83.14/test 1 ) Japan: 6,300 ($52.52/test 1 ) Strng health ecnmic case Multiple peer-reviewed publicatins SWITCH study with Jhns Hpkins Systematic analysis f true cst f running a TB screening prgram with the TST fr healthcare wrker screening in a large US urban hspital TST-based screening csts $73.20 per wrker An IGRA saves mney at a test cst $54.83 per test and results in higher cmpliance rates 1.Currency cnversins using Fx rates n 31 st December 2014 15
Cumulative Test Vlumes Cumulative test vlumes Eurpean Apprval First Eurpean guideline (UK) Secnd Eurpean guideline (DE) US Apprval ODL pens (CLIA certified) German reimbursement established (Jan) Revised UK guidelines (Mar) Revised German guidelines (May) CDC guidelines Chinese Apprval Chinese MOH listing Revised Japanese LTBI guidelines Japan MHLW Apprval (Oct.) and reimbursement listing (Nv.) SWITCH study published CPT cde and reimbursement established fr T-SPOT Perid / Year 16
Financial Prfile Strng revenue grwth CAGR ver last 18 quarters * f 58% Recurring revenue allws us t fcus sales teams primarily n driving grwth Multiple revenue grwth drivers US, China, Japan Quarter-t-quarter revenue vlatility Seasnality in US & Japan Vlatility in rder patterns t distributrs Grss margins expanding 33% in 2011 t 55% Q3 2015 Service margins cnverging with prduct margins T-SPOT.TB next generatin prvides additinal bst t service margins Sund financial fting ~$88M in cash * Up t, and including, Q3 2015 17
Key Investments Sales & Marketing investments Expansin f US institutinal segment sales team Expansin f US marketing and medical educatin Penetratin f new US segments Expansin f Japan sales team Market develpment activity in China Prduct pipeline investments Transplant pipeline 4 prducts s far Autimmune pipeline 3 prducts s far Immune-nclgy TBD 18
US Cmmercialisatin US market by segment Market segment by testing lcatin Segment size (tests/year) Indicative average pricing 1 Segment size ($ ptential) OXFD sales infrastructure Hspitals 7.0M ~$50/test ~$350M Direct Public & Student Health 1.5M ~$50/test ~$75M institutinal sales frce Physicians ffices / clinics 7.3M $75-95/test 2 ~$620M Direct physicians ffice sales frce Other * 6.0M Unknwn Unknwn Nt a fcus area currently TOTAL 22M tests >$1bn Surce: Cmpany analysis * Military, Crrectinal Facilities, Chrnic Care Hmes, Other 1. Based n revenue recgnised by testing labratry 2.CMS reimbursement fr CPT86481 is $102/test. Net cllectins will vary by payr 19
OUS Cmmercialisatin OUS 28M tests Split int tw regins Asia Eurpe & ROW Direct sales frce in Eurpe & Japan Distributin partners used elsewhere Primarily selling ur kit ffering Key fcus n China & Japan China pened market develpment ffice t supprt partner Japan building direct sales team 20
Prduct Pipeline Summary Prduct Name Indicatin Call pint 1 Market size 2 Cncept Feasibility Analytical Validatin Clinical Validatin T-SPOT.TB TB Hspital/ Phys. ffice >$1bn T-SPOT.CMV CMV Hspital $150M 2016 T-SPOT.PRT SpirFind GutiFind T-SPOT.ICA Organ rejectin Lyme disease Gut Immune cmpetence Hspital Physicians ffice Physicians ffice Hspital $300M $750M $400M $250M Cmmercial Launch 2017 2017+ 2017+ 2018+ B cell assay Organ rejectin Hspital TBD Stratkine I-O mnitring Autimmune disease Immune Onclgy Physicians ffice Hspital/ Phys. Office $500M TBD 1. US call pint. OUS call pints will vary slightly 2. Estimated glbal market pprtunity. Mid-pint f ranges used (runded) 21
T-SPOT.CMV Unmet Need Market Opprtunity Develpment Status Cytmegalvirus (CMV) is a cmmn viral pathgen: Usually cntrlled by T cells, causes disease when T cell functin is depressed Majr threat in transplants: One f mst cmmn infectins pst-transplant CMV threatens the transplant patient and the transplanted rgan Plays acrss all transplant types: Slid Organ transplants (SOT) Stem cell transplants (HCT) Repeat testing: Prphylaxis mnitring Prgnsis Viral expansin treatment decisins Market size $100-200m 1: Apprx. 1m tests per year Uses same platfrm as T-SPOT.TB Design verificatin cmplete: Early clinical evidence LDT & CE marked kit nw available Merit f measuring CMVspecific T cells is well accepted: Academic publicatins Guidelines 1. Surce: Cmpany estimates 22
T-SPOT.CMV Timeline Analytical Validatin Clinical Validatin Cmmercializatin 2015 2016 2017 H1 H2 H1 H2 H1 H2 Clinical Studies Initiate studies REACT HCT trial PROTECT slid rgan transplant Enrllment cmplete REACT HCT trial PROTECT slid rgan transplant Abstract REACT HCT trial PROTECT slid rgan transplant Publicatin REACT HCT Publicatin PROTECT slid rgan transplant Regulatry LDT (USA) CE marked kit (EU) Cmmercial Cmmercial launch (USA and EU) 23
T-SPOT.PRT Unmet Need Market Opprtunity Develpment Status The Panel Reactive T cells (PRT) assay addresses rgan rejectin Rejectin can be bth antibdy and T cell mediated Reducing rejectin is critical t transplant utcmes: Rejectin events shrten graft life & significantly increase csts Well validated analgue: PRA testing is standard f care and used repeatedly Repeat testing: Pre-transplant (waiting list) Pst-transplant Market size $250-400m 1: Apprx. 2.1m tests per year Uses same platfrm as T-SPOT.TB Design verificatin nging: Equivalence shwn t academic assay LDT available H2 15 Merit f measuring T cells is well accepted: Academic publicatins Understanding f rejectin mechanisms 1. Surce: Cmpany estimates 24
T-SPOT.PRT Timeline Analytical Validatin Clinical Validatin Cmmercializatin 2015 2016 2017 H1 H2 H1 H2 H1 H2 Clinical Studies Initiate study PROTECT slid rgan transplant Enrllment cmplete PROTECT slid rgan transplant Abstract PROTECT slid rgan transplant Publicatin PROTECT slid rgan transplant Regulatry LDT (USA) CE mark (EU) Cmmercial Cmmercial launch (US and EU) 25
Summary & Key Investment Highlights 1. Unique immune measuring tlbx Fcussed n the functinal measurement f immune cells at a single cell level Brad cverage f immune system: T cells, B cells and innate immunity Brings unique capability t develp nvel, prprietary tests fr immune diseases 2. First test, T-SPOT.TB t diagnse latent TB infectin, experiencing rapid cmmercial grwth Underserved market >$1BN market pprtunity Glbal regulatry clearances, scientific validatin, supprtive guidelines and validated cmmercial mdel 3. Extensive pipeline: Initially Transplantatin and Autimmune disease >$2BN market pprtunity First cmmercial launch in 2016 4. Strengthening financials Rapid revenue grwth Imprving grss margin Multiple revenue grwth drivers in near and lnger-term Sufficient cash t get the cmpany t prfitability 26
Appendices Oxfrd Immuntec Glbal PLC 94C Innvatin Drive Miltn Park, Abingdn Oxfrdshire, OX14 4RZ, United Kingdm Cmpany Number 08654254 www.xfrdimmuntec.cm 27
T-SPOT Technlgy Over 12 years f develpment, the T-SPOT technlgy has been ptimised t deliver an extremely rbust and reliable prcess Many key design imprvements have been achieved: Sample lgistics Bld stability / preserving T cell functin Standardizatin Autmatin Glbal regulatry apprval Oxfrd Immuntec has pineered an exceptinally sensitive technlgy that has wide ranging use fr the functinal measurement f immune cells 28
Unique Attributes f the T-SPOT Platfrm The T-SPOT platfrm is exquisitely sensitive, measuring immune cell respnses at a single-cell level Measures functinal respnses Measures multiple cell types Sample nrmalisatin allws valid lngitudinal mnitring Significant advantages ver ther techniques such as ELISA 29
A Unique Immunlgy Tlbx Fcused n functinal measurement f the immune system at a cellular level Adaptive Immunity Humral (B cell Immunity) Cellular (T cell Immunity) Innate Immunity T cell B cell Basphil Macrphage Mast cell γδ T cell Antibdies CD4+ T cell CD8+ T cell Natural Killer T cell Granulcytes Esinphil Neutrphil Natural Killer cell Dendritic Cell Cmplement Prtein 30
Oxfrd Immuntec Glbal PLC 94C Innvatin Drive Miltn Park, Abingdn Oxfrdshire, OX14 4RZ, United Kingdm Cmpany Number 08654254 www.xfrdimmuntec.cm 31