Oxfrd Immuntec Cmpany Overview Nvember 2017 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 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 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 high-grwth, glbal diagnstics cmpany Memphis, TN ODL CLIA lab LDT develpment Manufacturing Bstn, MA US Headquarters US cmmercial peratins Tick-brne disease lab and R&D Secnd ODL CLIA lab T-SPOT, ODL and the Oxfrd Immuntec and Imugen lgs are trademarks f Oxfrd Immuntec Ltd. Immunetics is a trademark f Immunetics, Inc. 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 Ykhama, Japan Japan Headquarters Japan cmmercial peratins
Cmpany Fcus T develp and cmmercialize prprietary assays fr underserved immune-regulated cnditins 4
Immune-regulated Cnditins Our target markets Infectius disease Particularly thse that can becme chrnic depending n immune cntrl (e.g. TB, Lyme) Or thse that afflict thse with weakened immune systems (e.g. TB, CMV, Babesisis) Transplantatin Relies n balancing the immune system Suppress enugh t prevent rejectin withut making the patient t weak t fight infectins Autimmune / inflammatry Caused by an inapprpriate immune respnse against self Immune nclgy Cancer is an immunlgical disease, as the immune system is unable t sufficiently recgnize and/r fight the tumr 5
Cmmercial Prducts and Late-Stage Pipeline Brand Market Indicatin Market size 1 Cncept Feasibility Analytical Validatin Clinical Validatin Infectius disease Tuberculsis screening >$1bn Infectius disease Infectius disease Transplant / Infectius disease Lyme and ther tick-brne diseases Babesia bld screening $450m 2 TBD Cytmegalvirus $150m Cmmercial Launch 1 Estimated glbal market pprtunity; mid-pint f ranges used (runded). Market size fr T- SPOT.TB based n full cnversin f LTBI screening tests perfrmed each year at current ASP 2 US nly. OUS market nt yet sized. 6
TB Screening A majr glbal market pprtunity ~50M Latent TB Infectin (LTBI) screening tests perfrmed each year 1 >$1BN estimated market pprtunity 2 1 Diagnstics fr Tuberculsis: Glbal Demand and Market Ptential. WHO 2006 2 Cmpany estimate; market size based n full cnversin f LTBI screening tests perfrmed each year at current ASP 7
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 8
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 9
Key Fundatins fr T-SPOT.TB Grwth Established Regulatry apprval T-SPOT.TB apprved in >50 cuntries wrldwide, including US (FDA), Eurpe (CE mark), Japan (MHLW) and China (SFDA) Significant bdy f clinical evidence Almst 500 publicatins in the peer-reviewed literature Widespread guidelines recmmendatins IGRAs recmmended in at least 34 cuntries wrldwide including in US, Eurpe, Japan, and China Widespread reimbursement Demnstrated cst-effectiveness Unique CPT 1 cde in US (Medicare at $102/test) >300m cvered lives in the US Explicit reimbursement cverage in many ther cuntries such as Japan, China, France and Germany 1. CPT is a registered trademark f the American Medical Assciatin 10
Significant Cmmercial Adptin With substantial headrm fr further grwth 2004-8 2010 CE mark (Eurpean apprval), 1 st Eurpean guideline, US FDA apprval CDC guidelines issued in US Chinese SFDA apprval 2011 CPT cde & US Medicare reimbursement established 2012 2013 2014 2015 2016 2017 Japanese MHLW apprval & reimbursement established SWITCH health ecnmic study published in US T-SPOT.TB apprved fr sale in >50 cuntries Revised Japanese guidelines Opened market develpment ffice in China Hired salesfrce in Japan Entered int US physicians ffice market segment Exceeded 300m cvered lives in the US USPTF Grade B recmmendatin UK NHS Tender fr new entrant screening Revised US guidelines (ATS/IDSA/CDC) Suth Krea new screening guidelines French reimbursement Expanded guidelines in China 11
Glbal Cmmercial Channel Established Kit and service mdel United States Direct sales frce in US Principal call pints: hspitals, public health, physicians ffices Primarily selling ur service ffering Eurpe & ROW Direct sales frce in Eurpe Principal call pints: hspitals, public health, private labs Distributin partners used in ROW Primarily selling ur kit ffering Service in the UK Asia Direct sales frce in Japan Principal call pints: hspitals, private labs, rheumatlgy Presence in China & S. Krea Market develpment ffice Selling ur kit ffering 12
Tick-brne Disease Franchise Diagnstic lab specializing in tick-brne diseases Full range f assays, utilizing differentiated techniques CLIA certified and CAP accredited labratry in the Bstn area Prducts supprted by numerus peerreviewed publicatins R&D cmpany specializing in infectius disease Principal prduct is C6 ELISA fr the diagnsis f Lyme disease FDA cleared and CE marked Prduct supprted by numerus peer-reviewed publicatins 13
Tick-brne Pathgens Pse a Significant Health Risk Adverse health cnsequences Lyme Disease Chrnic jint inflammatin (Lyme arthritis) Facial palsy and neurpathy Cgnitive defects Heart rhythm irregularities Anaplasmsis Difficulty breathing Hemrrhage Renal failure, neurlgical prblems Death (in rare cases) Ehrlichisis Difficulty breathing Hemrrhage and bleeding disrders Death (in rare cases) Ticks, especially at the nymph stage, are abut the size f a pppy seed, making them exceedingly difficult t detect Babesisis Lw and unstable bld pressure Severe hemlytic anemia Malfunctin f vital rgans Death (in rare cases) Surces: CDC, University f Rhde Island 14
The Spread f Lyme Disease Reprted cases f Lyme Disease t the CDC, 2001 and 2015 There were ~5m specimens tested fr Lyme disease in 2015 Large and grwing market. Estimated US TAM: $400-$500m Surces: CDC, Oxfrd Immuntec analysis 15
Imprtance f Other Tick-brne Infectins Lyme disease Anaplasmsis Ehrlichisis Babesisis Other cmmn tick-brne diseases are prevalent and are expanding Other tick-brne diseases can masquerade as Lyme disease, since symptms are similar C-infectins in endemic regins are cmmn It is imprtant t test fr mre than just Lyme disease Surce: CDC 16
Tick-brne Disease Market Segments Acute presentatin Unmet Needs / Opprtunities Mre sensitive tests required in early detectin Need t test fr cinfectins as well as Lyme Our Slutins Imugen has differentiated assays whse purpse is t increase sensitivity in early Lyme infectin Imugen cvers the majr tick-brne diseases, and has cinfectin data t educate market Late presentatin Need fr mre sensitive, specific and cst-effective testing t replace r streamline tw-step testing Tests needed that can indicate therapy respnse and/r cure Immunetics test can replace ne r bth f the current generic tw-step tests with better perfrmance Imugen s tests, as well as ur pipeline, aim t address this need 17
Key Fundatins fr Grwth Established Regulatry apprval Imugen s lab is CLIA-certified and CAP-accredited Immunetics has FDA & CE clearance fr its C6 ELISA test Differentiated, better perfrming tests Imugen and Immunetics have differentiated tests, bradly addressing the unmet market needs Widespread reimbursement Tests are cvered under existing cdes Strng cmmercial channel Tick-brne diseases verlap well with ur current TB call pints, enabling us t leverage ur current sales frce in the US and OUS We can bring a strng vice t markets that are underserved and undereducated 18
Babesia as a Risk t the US Bld Supply = incidence prir t implementatin f screening = prir generatins f screening = incidence with current screening Hepatitis B HIV Hepatitis C HTLV 1/2 West Nile Virus Babesia 1:10,000 1:100,000 1:1,000,000 Increasing risk Incidence rate Decreasing risk Surces: FDA Bld Prducts Advisry Cmmittee Meeting May 2015, Cmpany analysis 19
Our Slutins Test Develper Serlgical Assay AFIA Lab service (under FDA review) Nucleic Acid Test (NAT) PCR Lab service (under FDA review) ELISA Kit (under FDA review) N.A. Screening fr Babesia micrti in the U.S. Bld Supply New England Jurnal f Medicine 2016;275:2236-45 20
Ptential Market fr Babesia Screening f Dnr Bld After the FDA clears a bld screening assay, it typically issues guidance fr its utilizatin with the dnr bld screening industry. In May 2015, FDA s Bld Prducts Advisry Cmmittee (BPAC) cnvened and prpsed the fllwing recmmendatins fr Babesia testing in dnr bld. All States (Endemic and nn-endemic): The cmmittee vted t recmmend year-rund serlgical testing in all 50 states = ~13m tests Endemic States: The cmmittee vted t recmmend year-rund NAT testing (cupled with serlgical testing) in the 9 mst endemic states = ~2m tests Nine endemic states = NY, MA, ME, CT, RI, NJ, MN, WI, NH Surce: FDA BPAC meeting May 2015 21 Nte: FDA guidance, if issued, may vary frm the May 2015 BPAC Cmmittee s vte
Transplantatin Cmpany Spnsred Trials Transplant Type Enrllment T-SPOT.CMV measures the strength f the T cell respnse against Cytmegalvirus (CMV) 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 the mst cmmn infectins pst-transplant CMV threatens the transplant patient and the transplanted rgan Interim data presented in Q1 2017 Additinal data t be presented in early-t-mid 2018 PROTECT: A PRspective Observatinal Trial t Evaluate the Crrelatin f T-SPOT Respnse t CMV Infectin and T cellmediated Acute Graft Rejectin REACT: A Prspective Observatinal Trial t Evaluate Hematpietic Stem Cell Transplantatin CMV Reactivatin Events Assessed by a CMV specific T-SPOT Assay 22 Investigatr-Led Studies Investigatin f test utility in using baseline respnse t stratify patients regarding preemptive vs. prphylactic therapy Investigatin f test utility fr the management f HCT patients with lw viral lads Investigatin f predictive value f the test in SOT as cmpared t ther CMV IGRAs SOT (Kidney) ~600 HCT ~250 Transplant Type SOT (Kidney) Enrllment ~180 HCT ~50 SOT (Kidney & Liver) 50
Financial Prfile Strng revenue grwth >20% annual CC revenue grwth fr 12 straight years Recurring revenue allws us t fcus sales teams primarily n driving grwth FY 17 guidance f $103.5-$104.5m (+21%-22% YY CC) Multiple current and future grwth drivers Prducts: TB, Tick-brne disease, Bld banking, Transplant Gegraphies: US, Eurpe, China, Japan, Suth Krea Quarter-t-quarter revenue vlatility Seasnality in US and Japan Vlatility in rder patterns t distributrs Grss margins expanding 33% in 2011 t 54% in 2016 Sund financial fting ~$68m in cash as f September 30, 2017 23
Key Pririties Cntinue ur strng revenue grwth Cntinued penetratin f T-SPOT.TB int the >$1bn TB screening market IGRAs nly 15-20% penetrated Drive penetratin f the Imugen and Immunetics tests int the $450m tick-brne disease market Leverage ur cmmercial resurces t expand the awareness f ur differentiated ffering Cntinue t add additinal prducts t ur sales frce and CLIA lab infrastructure Launch f bld banking tests fr Babesia and transplant test Cntinue t add prducts thrugh R&D and M&A Mve cmpany twards prfitability Increase grss margins Drive leverage thrugh perating expense lines 24
Summary & Key Investment Highlights Playing in large, grwing, underserved markets Prprietary, industry-leading prducts Well develped, glbal cmmercial infrastructure Diversified, recurring revenue streams Strng revenue grwth Pathway t prfitability 25
Appendix Oxfrd Immuntec Glbal PLC 94C Innvatin Drive Miltn Park, Abingdn Oxfrdshire, OX14 4RZ, United Kingdm Cmpany Number 08654254 www.xfrdimmuntec.cm 26
Q3 Earnings Call - Screcard Revenues Q3 2017: $30.4m +17% YY (as reprted and CC) US $18.8m +16% YY Eurpe & ROW $2.2m +26% YY (+22% CC) Asia $9.4m +15% YY (+18% CC) TiBD cntinues t grw strngly and ahead f initial expectatins. US TB vlumes impacted by decline in immigratin numbers and recent hurricanes. Grss Margins Q3 2017 56.7% grss margin (up 450 bps sequentially and 80 bps YY) TB grss margins cntinue t expand, but were ffset by a higher percentage f tickbrne disease revenue which currently carries lwer margins than TB. Making prgress n expanding TiBD margins t crprate average. Pipeline As we near the end f ur pipeline review and R&D re-priritizatin, fur fcus areas within ur pipeline have emerged: T-SPOT.TB enhancements, building a market leadership psitin in TiBD, Babesia bld screening, and T-SPOT.CMV. BLAs cntinue t prgress with FDA licensure expected in early 2018. Other FY revenue guidance updated t $103.5-$104.5m (+20-21% YY; +21-22% YY CC) 27
A Unique Immunlgy Tlbx Fcused n functinal measurement f the immune system at a cellular level Adaptive Immunity Humral (B cell Immunity) Cellular (T cell Immunity) Innate Immunity T cell B cell Basphil Macrphage Mast cell γδ T cell Antibdies CD4+ T cell CD8+ T cell Natural Killer T cell Granulcytes Esinphil Neutrphil Natural Killer cell Dendritic Cell Cmplement Prtein 28
T-SPOT Technlgy Over 12 years f develpment, the T-SPOT technlgy has been ptimised t deliver an extremely rbust and reliable prcess Many key design imprvements have been achieved: Sample lgistics Bld stability / preserving T cell functin Standardizatin Autmatin Glbal regulatry apprval Oxfrd Immuntec has pineered an exceptinally sensitive technlgy that has wide ranging use fr the functinal measurement f immune cells 29
US TB Screening Market & Segments Principal screened ppulatins US market by segment Market segment by testing lcatin Segment size (tests/year) Indicative average revenue/test 2 Segment size ($ ptential) OXFD sales infrastructure Hspitals 7.0M ~$50/test ~$350M Public & Student Health 1.5M ~$50/test ~$75M Cvered by direct sales frce Physicians ffices / clinics 7.3M $75-$95/test 3 ~$620M Cvered by direct sales frce Other 1 6.0M Unknwn Unknwn Nt a fcus area currently TOTAL 22M tests >$1bn Surce: Cmpany analysis; market sizes based n full cnversin f LTBI screening tests perfrmed each year at current ASP 1. Military, Crrectinal Facilities, Chrnic Care Hmes, and Other 2. Based n revenue recgnised by testing labratry 3. CMS reimbursement fr CPT 86481 is $102/test. Net cllectins will vary by payr 30