Oxford Immunotec
Company Overview
4th August 2020
Oxford Immunotec Global PLC
94C Innovation Drive
Milton Park, Abingdon
Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 www.oxfordimmunotec.com
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-CellSelect™, T-CellXtend®, "Oxford Diagnostic Laboratories®," "ODL®," "Immunetics®," our laboratory logo and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
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Global Specialised Diagnostics Company
Focused on proprietary assays for immunology and infectious disease
Boston, MA | Oxford, UK | |||
• US headquarters | • Main headquarters | |||
• US commercial operations | • Europe & ROW commercial operations | |||
• Product development | • Manufacturing | |||
• Product development | 3 | |||
• UK ODL lab |
Singapore
- APAC headquarters
- Regional commercial offices in Shanghai, China, Yokohama, Japan and Seoul, S. Korea
COVID-19
Financial
- Revenues reduced as TB testing volumes have reduced due to COVID-19 restrictions.
- Q2 was low point
- Consumption rebounding in all regions
- Expect to return to prior revenue run-rate starting in Q3
- ~$165m in cash and no debt. No financing concerns.
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.
- T-SPOTDiscovery SARS-CoV-2 test launched.
- Measures T cell responses to SARS-CoV-2, which may play a future role in our control of the pandemic.
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 | 4 |
business. The T-SPOT Discovery SARS-CoV-2 test is for research use only. We may chose to pursue an IVD |
in due course. Q3 revenue guidance $18-19m.
Tuberculosis: The World's Deadliest Infectious Disease
10,000,000 | Top 10 cause of death globally |
new cases | from a single infectious agent |
1,600,000 | |
Leading cause of death worldwide | |
deaths |
Source: Global Tuberculosis Report 2018. Geneva: World Health Organization (WHO); 2018. | 5 |
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
- 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
- Prevents future cases - prevents future transmission
Sources: | |
Global Tuberculosis Report 2018. Geneva: WHO; 2018. | 6 |
The End TB Strategy. Geneva: WHO; 2018. |
Reactivation
Reinfection
TB Screening: A Major Global Market Opportunity
>70M Latent TB Infection
(LTBI) screening tests performed each year
Sources: Koncept Analytics, WHO | 7 |
The Current Screening Test for TB
Tuberculin 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:
- Prior BCG vaccination
- 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: | 8 |
Diagnostics for Tuberculosis: Global Demand and Market Potential. Geneva: WHO; 2006. |
Market Replacing TST with IGRA Blood Tests
- Our solution: the T-SPOT.TB test
- Blood test based on immunology; generically referred to as
an interferon-gamma release assay
- One of two recommended alternatives to TST
- IGRAs have several advantages over the TST
- Higher specificity (fewer false positives)
- No need for specifically trained healthcare workers
- No need for return visit
- However, different technology to other IGRAs
- Higher sensitivity, performance in immunosuppressed
- Simple phlebotomy, blood logistics
Note: Guidelines and Package insert claims vary by geography. Please consult local package inserts | 9 |
for label claims, and local guidance documents for your country | |
Significant Commercial T-SPOT.TB Adoption
2004-8 | CE mark (EU approval), 1st EU guideline, US FDA approval |
2010- | CDC guidelines issued in US; Chinese SFDA approval |
CPT code & US Medicare reimbursement established | |
2012 | Japanese MHLW approval & reimbursement established |
SWITCH health economic study published in US | |
2013- | T-SPOT.TB approved for sale in >50 countries |
2015 | Revised Japanese guidelines; hired salesforce in Japan |
2016- | UK NHS Tender for new entrant screening |
USPTF Grade "B" recommendation & revised ATS/IDSA/CDC guidelines | |
2017 | New screening guidelines in South Korea & expanded guidelines in China |
French reimbursement | |
CDC decision requiring use of IGRA | |
2018- | New WHO latent TB guidelines |
2019 | IGRAs included in first-ever WHO Essential Diagnostics List |
AAP recommends use of IGRAs in children as young as two years old | |
Launched T-CellSelect and automation in Europe | |
2020 | Completed transition to direct commercial model in China |
Long-term supply agreement with Global Drug Facility | |
Source: Oxford Immunotec company reports | 10 |
Well Positioned for Growth
Overall Market Growth
• | Market growth forecast at 5% CAGR (2018-2023) | |
Conversion from TST | • | Overall market growth driven by expanded role for LTBI testing & |
treatment | ||
Take Share | • | Market only ~20% converted to IGRAs from TST |
• | Guidelines becoming more favourable to IGRAs |
- 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
11 | Source: Company Reports, Koncept Analytics |
Well Positioned for Growth
Overall Market Growth
Conversion from TST
Take Share
Key Initiatives
- Deliver automation to our customers globally
- Improve economics for our customers
- Expand Sales & Marketing teams
- Execute commercial partnerships to expand reach
- Expand our geographical coverage
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T-SPOT.TB Automation
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
T-CellSelect has not been approved or cleared for use in all jurisdictions | 13 |
with the T-SPOT.TB test. |
Asia Expansion
- No. 1 IGRA brand in Japan
- Used by all the major lab groups in Japan
- Focussed on continued test volume expansion through market development and on automation
- No. 1 IGRA brand in China
- Market projected to grow strongly
- Going more direct improves revenue and profits, whilst also giving us the ability to grow our brand more strongly
- Transition to direct model complete; partnering with Shanghai Pharmaceuticals on reach into the market
- Opened APAC hub in Singapore
- Expanding presence in SE Asia
China IGRA market
(tests 'Ms)
5.9
2.6
2018 2025
14 | Source: IQVIA, Company Estimates |
US: The Largest Single Market for LTBI Screening
Principal Screened Populations
US Market by Segment
Market Segment by | Segment Size |
Testing Location | (Tests/Year) |
Hospitals | 2.5M |
Public & Student Health | 1.5M |
Physicians' Offices/Clinics | 7.3M |
Other1 | 6.0M |
TOTAL | ~17M |
Source: Oxford Immunotec analysis | 15 |
1 Military, Correctional Facilities, Chronic Care Homes, and Other |
Quest Diagnostics: A Key Channel for T-SPOT.TB
By leveraging Quest's reach and capabilities, US market access for T-SPOT.TB is being significantly increased
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
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New Russia Channel
- No. 1 IGRA brand in Russia
- Significant market opportunity
- High TB burden, established screening programs
- Recent commercial partnership unlocks new opportunities
- Collaboration with local companies for local manufacturing & promotion of T-SPOT.TB tests
- Local version approved mid 2019, unlocks new opportunities
Russia revenue growth
3x growth
2017 2018 2019
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Global Drug Facility (GDF)
- Long-termsupply 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 | 18 |
http://www.stoptb.org/assets/documents/gdf/drugsupply/GDFProductCatalog.pdf |
Leveraging Our T Cell Measurement Platform (T-SPOT) in COVID19
- T-SPOTis a technology platform for measuring T cells
- Applying what we've learnt in TB to SARS- CoV-2
- Launched RUO product to measure T cell responses in COVID19
- T-SPOTDiscovery SARS-CoV-2
- Participating in studies to show role of T cells and how T cell responses could complement PCR/antigen testing and serology
- Positioning ourselves to move quickly if a use case for routine clinical testing of T cells emerges
Adapted from "COVID-19 response: The role of diagnostics". WHO.int and | 19 |
Channappanavar R, Zhao J, Perlman S et al. T cell-mediated immune response to respiratory coronaviruses. Immunol Res. 2014. 59:118-128
Financial Profile
-
Strong pre-COVID19 momentum in TB business o 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 profile
o 73.8% gross margin2
o Investing in manufacturing automation to further drive down COGS
- Improving bottom-lineprofitability profile o H2 '19 Adjusted EBITDA positive
- Strong balance sheet
o ~$165M in cash and no debt3
1 Pro forma revenues and gross margin shown for 2017 and 2018 excluding blood donor | 20 | 2 | FY 2019 gross margin of 73.8% |
screening revenues | 3 | $165.5M as of June 30th 2020 |
Key Priorities for 2020
• Sales & marketing investments to maximize profitable growth | ||
Revenue | • | Leverage channel partnerships |
Growth | • | Extend geographical coverage |
• Expand approvals for Automation worldwide, build installed base of users | ||
Profitability | • Continue to expand gross margins | |
• Maintaining business at/around Adjusted EBITDA breakeven | ||
Uses of | • Investing for sustainable long-term growth of the business | |
• Additional products: R&D, Corporate Development | ||
Cash | ||
• 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
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Oxford Immunotec Global plc published this content on 04 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 August 2020 12:56:10 UTC