oxford immunotec · 2020. 11. 9. · 1 oxford immunotec global plc 94c innovation drive milton...
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Oxford Immunotec Global PLC94C Innovation Drive
Milton Park, Abingdon
Oxfordshire, OX14 4RZ, United Kingdom
Company Number 08654254
www.oxfordimmunotec.com
Oxford Immunotec Company Overview
3rd November 2020
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Forward-Looking Statements
Certain information contained in this presentation constitutes forward-looking statements, including those related to
anticipated plans and objectives, future performance and revenues, financial condition, prospects, growth, strategies,
expectations and objectives of management, as well as beliefs and expectations regarding the impact of COVID-19.
Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. The
financial results and forward-looking statements contained in this presentation reflect our current expectations and are
subject to risks and uncertainties. Actual results may differ materially from those projected or implied by forward-looking
statements. Please review our SEC filings for more information regarding those factors that could cause actual results
and events to differ materially from those indicated in the forward-looking statements. Our filings are available for free by
visiting the investor section of our website, www.oxfordimmunotec.com, or the SEC's website, www.sec.gov.
Investors should give careful consideration to these risks and uncertainties. Forward-looking statements contained
herein are based on current expectations and assumptions and currently available data and are neither predictions nor
guarantees of future events or performance. You should not place undue reliance on forward-looking statements
contained herein, which speak only as of the date of this presentation. We do not undertake to update or revise any
forward-looking statements after they are made, whether as a result of new information, future events, or otherwise,
except as required by applicable law.
T-SPOT®, T-Cell Select™, T-Cell Xtend®, “Oxford Diagnostic Laboratories®,” “ODL®,” “Immunetics®,” our laboratory logo
and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
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Global Specialty Diagnostics Company
Experts in T cell immunology with an established global presence in infectious disease
Boston, MA
• US headquarters
• US commercial operations
• Product development
Oxford, UK
• Main headquarters
• Europe & ROW commercial operations
• Manufacturing
• Product development
• UK ODL lab
Singapore
• APAC headquarters
• Regional commercial offices in
Shanghai, China, Yokohama, Japan
and Seoul, S. Korea
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COVID-19
Financial
• Revenues reduced as TB testing
volumes have reduced due to
COVID-19 restrictions.
o Q3 revenues down 8% vs PY
o Asia-Pacific region returned to growth
in Q3 and set new quarterly sales
record for the region
o Expect full company to return to
growth in Q4
• ~$160m in cash and no debt. No
financing concerns.
These statements represent our beliefs and/or facts at the time of writing. Please also see our materials and
filings with the SEC for more information, including the impacts of, and risks related to, COVID-19 on our
business. The T-SPOT Discovery SARS-CoV-2 test is for research use only. We may chose to pursue an IVD
in due course. Q4 revenue guidance of $19-20m
Operational
• No material disruption to our supply chain
and we have continued to supply customers
without constraints.
• Continue to invest in strategically important
projects, and we continue to hire.
• Continued progress on R&D and other
corporate projects.
o T-SPOT Discovery SARS-CoV-2 test launched.
o Measures T cell responses to SARS-CoV-2,
which may play a future role in our control of
the pandemic.
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Tuberculosis: The World’s Deadliest Infectious Disease
Source: Global Tuberculosis Report 2018. Geneva: World Health Organization (WHO); 2018.
10,000,000
1,600,000
new cases
deaths
Top 10 cause of death globally
Leading cause of death worldwide
from a single infectious agent
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Tuberculosis Control Relies on Screening for Latent TB
“Ending the tuberculosis epidemic will require the elimination of this [reservoir] of infection”
- World Health Organization, The End TB Strategy
Rein
fectio
n
Re
ac
tiva
tio
n• 1.7 billion people are estimated to have a latent
TB infection
• Individuals with latent TB infection are at risk of
developing active TB disease during their lifetime
• Screening for TB infection is a critical element of
TB control
o Prevents future cases – prevents future
transmission
Sources:
Global Tuberculosis Report 2018. Geneva: WHO; 2018.
The End TB Strategy. Geneva: WHO; 2018.
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TB Screening: A Major Global Market Opportunity
Sources: Koncept Analytics, WHO
>70M Latent TB Infection
(LTBI) screening tests
performed each year
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The Current Screening Test for TBTuberculin Skin Test (‘TST’)
“This method has been in clinical use for more than 90
years. Unfortunately, its application is problematic due to
the frequency of false-positive and false-negative skin
reactions.”
- World Health Organization, Diagnostics for Tuberculosis
Main Limitations
• Low sensitivity, especially in immunosuppressed, newborns, and elderly
• Poor specificity due to:
o Prior BCG vaccination
o Environmental mycobacteria
• Requires a return visit for reading
• Inoculation and reading are technique-dependent and require specially-trained operators
• Recurrent supply shortages of purified protein derivative (PPD), the test substance used
• Collectively these issues result in inefficient use of healthcare resources
Source:
Diagnostics for Tuberculosis: Global Demand and Market Potential. Geneva: WHO; 2006.
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Market Replacing TST with IGRA Blood Tests
• Our solution: the T-SPOT.TB testo Blood test based on immunology; generically referred to as
an interferon-gamma release assay
o One of two recommended alternatives to TST
• IGRAs have several advantages over the TSTo Higher specificity (fewer false positives)
o No need for specifically trained healthcare workers
o No need for return visit
• However, different technology to other IGRAso Higher sensitivity, performance in immunosuppressed
o Simple phlebotomy, blood logistics
Note: Guidelines and Package insert claims vary by geography. Please consult local package inserts
for label claims, and local guidance documents for your country
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Significant Commercial T-SPOT.TB Adoption
2004-8 CE mark (EU approval), 1st EU guideline, US FDA approval
2010-
2012
CDC guidelines issued in US; Chinese SFDA approval
CPT code & US Medicare reimbursement established
Japanese MHLW approval & reimbursement established
SWITCH health economic study published in US
2013-
2015
T-SPOT.TB approved for sale in >50 countries
Revised Japanese guidelines; hired salesforce in Japan
2016-
2017
UK NHS Tender for new entrant screening
USPTF Grade “B” recommendation & revised ATS/IDSA/CDC guidelines
New screening guidelines in South Korea & expanded guidelines in China
French reimbursement
2018-
2019
CDC decision requiring use of IGRA
New WHO latent TB guidelines
IGRAs included in first-ever WHO Essential Diagnostics List
AAP recommends use of IGRAs in children as young as two years old
Launched T-Cell Select and automation in Europe
2020Completed transition to direct commercial model in China
Long-term supply agreement with Global Drug Facility
Source: Oxford Immunotec company reports
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Well positioned for growth along 3 Growth Vectors
• T-SPOT.TB currently ~25% of IGRA market overall, but
has become leading brand in several countries on basis of
differentiated performance & pre-analytical workflow
• NEW: Automation, Improved economics
• Market only ~20% converted to IGRAs from TST
• Guidelines becoming more favourable to IGRAsOverall Market Growth
Conversion from TST
Take Share
Source: Company Reports, Koncept Analytics
• Market growth forecast at 5% CAGR (2018-2023)
• Overall market growth driven by expanded role for LTBI testing & treatment
+
+
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To maximise our growth, we need to focus on 4 things
Overall Market Growth
Conversion from TST
Take Share
+
+
4 Key Initiatives
• Expand our commercial channel
• Improve economics for our
customers
• Differentiate and extend our market-
leading test performance
• Deliver automation to our customers
globally
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T-SPOT.TB Automation
T-Cell Select has not been approved or cleared for use in all jurisdictions
with the T-SPOT.TB test.
New T-Cell Select accessory kit enables automation of T-SPOT.TB,
providing unrivaled sample stability and simplicity of blood collection
• Most flexible logistics
• Expands laboratory reach
• Enables sample batching
• Reduced hands-on time
• Improved throughput
• Improved economics
+ =
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Asia Expansion
• No. 1 IGRA brand in Japan
o Used by all the major lab groups in Japan
o Focussed on continued test volume expansion
through market development and on
automation
• No. 1 IGRA brand in China
o Market projected to grow strongly
o Going more direct improves revenue and
profits, whilst also giving us the ability to grow
our brand more strongly
o Transition to direct model complete; partnering
with Shanghai Pharmaceuticals on reach into
the market
• Opened APAC hub in Singapore
o Expanding presence in SE Asia
2.6
5.9
2018 2025
China IGRA market (tests ‘Ms)
Source: IQVIA, Company Estimates
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US: The Largest Single Market for LTBI Screening
Source: Oxford Immunotec analysis1 Military, Correctional Facilities, Chronic Care Homes, and Other
Market Segment by
Testing Location
Segment Size
(Tests/Year)
Hospitals 2.5M
Public & Student Health 1.5M
Physicians’ Offices/Clinics 7.3M
Other1 6.0M
TOTAL ~17M
US Market by Segment
Principal Screened Populations
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Quest Diagnostics: A Key Channel for T-SPOT.TB
Phlebotomy access
Electronic test ordering and results provision
Established customer base & relationships
Quest salesforce
Achievements to date
All 2,200+ PSCs being brought online
National Test Code live mid 2019
All 3 Quest JVs live + Chantilly lab. First of
Quest regions close to full integration
>20,000 new ordering providers in 2019
By leveraging Quest’s reach and capabilities, US market access
for T-SPOT.TB is being significantly increased
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New Russia Channel
• No. 1 IGRA brand in Russia
• Significant market opportunity
o High TB burden, established screening
programs
• Recent commercial partnership
unlocks new opportunities
o Collaboration with local companies for
local manufacturing & promotion of
T-SPOT.TB tests
o Local version approved mid 2019,
unlocks new opportunities 2017 2018 2019
Russia revenue growth
3x growth
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Global Drug Facility (GDF)
• Long-term supply agreement signed to provide
T-SPOT.TB to the GDF at preferential pricing for high-
burden TB countries.
• The Stop TB Partnership’s GDF is the largest global
provider of TB diagnostics, medicines, and laboratory
supplies to eligible national TB control programs.
• The organization works to ensure an uninterrupted
supply of affordable diagnostics and anti-TB
medications to patient populations in the greatest need.
• Centralised procurement mechanism for Quality
assured, WHO recommended products for high burden
countries.
Sources: StopTB Website and Product Catalogue
http://www.stoptb.org/assets/documents/gdf/drugsupply/GDFProductCatalog.pdf
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Leveraging Our T Cell Measurement Platform (T-SPOT) in COVID-19
Adapted from “COVID-19 response: The role of diagnostics”. WHO.int and
Channappanavar R, Zhao J, Perlman S et al. T cell-mediated immune response to respiratory coronaviruses. Immunol Res. 2014. 59:118-128
• T-SPOT is a technology platform for measuring T
cells
o Launched RUO product T-SPOT Discovery SARS-
CoV-2 to measure T cell responses in COVID-19
• Selected by UK government to provide T cell
testing in support of COVID-19 vaccine candidates
o T cells likely to provide important information on prior
exposure, cross-reactive T cell memory, and on
immunity
• Positioning ourselves to move quickly if a use case
for routine clinical testing of T cells emerges
o Pursuing FDA EUA clearance and CE mark
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Financial Profile
• Strong pre-COVID19 momentum in TB businesso Recurring revenue allows us to focus sales teams
primarily on driving growth
o Broad-based growth across US, Asia, and Europe
& ROW
• Strong gross margin profileo 73.8% gross margin2
o Investing in manufacturing automation to further
drive down COGS
• Improving bottom-line profitability profileo H2 ‘19 Adjusted EBITDA positive
• Strong balance sheeto ~$160M in cash and no debt3
1 Pro forma revenues and gross margin shown for 2017 and 2018 excluding blood donor
screening revenues
2 FY 2019 gross margin of 73.8%3 $160.6M as of Sep 30th 2020
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Key Priorities for 2020
Revenue
Growth
• Sales & marketing investments
• Leverage channel partnerships
• Extend geographical coverage
• Expand approvals for Automation worldwide, build installed base of users
Profitability • Continue to expand gross margins
Uses of
Cash
• Investing for sustainable long-term growth of the business
• Additional products: R&D, Corporate Development
• Capacity expansion: facilities, automation, systems
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Summary & Key Investment Highlights
• Leadership position in new class of testing for world’s deadliest infectious disease
• Very large, growing, underserved market
• Differentiated, industry-leading immunology technology
• Diversified, recurring revenue streams
• Multiple drivers of long-term revenue growth
• Strong gross margins
• Significantly improving profitability
• Strong balance sheet
• Broad opportunities to build value in the business