Oxford Immunotec Company Overview 35th Annual J.P. Morgan Healthcare Conference January 2017
Dr. Peter Wrighton-Smith, Chief Executive Officer
Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 www.oxfordimmunotec.com
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Forward-looking Statements Certain information contained in this presentation constitutes forward-looking statements, including those related to future performance and revenues, financial condition, prospects, growth, strategies, expectations and objectives of management. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. The preliminary 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 EDGAR on the SEC Web site at www.sec.gov. Forward-looking statements 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, 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.
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Company Profile We are a high-growth, global diagnostics company
Memphis, TN • ODL CLIA lab • LDT development • Manufacturing
Boston, MA • US Headquarters • US commercial operations • Imugen and future ODL CLIA lab • Immunetics business • Tick-borne disease R&D
T-SPOT, ODL and the Oxford Immunotec and Imugen logos are trademarks of Oxford Immunotec Ltd. Immunetics is a trademark of Immunetics, Inc.
Oxford, UK • OUS Headquarters • OUS commercial operations • Manufacturing • Product development 3 • UK ODL lab
Shanghai, China • China market development office • Medical education, marketing, technical support
Yokohama, Japan • Japan Headquarters • Japan commercial operations
Company Focus
To develop and commercialise proprietary assays for underserved immune-regulated conditions
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Immune-regulated Conditions Our target markets Infectious disease • Particularly those that can become chronic depending on immune control (e.g. TB, Lyme) • Or those that afflict those with weakened immune systems (e.g. TB, CMV, Babesia)
Transplantation • Relies on balancing the immune system • Suppress enough to prevent rejection without making the patient too weak to fight infections
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Autoimmune / inflammatory
Immune oncology
• Caused by an inappropriate immune response against self
• Cancer is an immunological disease, as the immune system is unable to sufficiently recognise and/or fight the tumour
Products and Pipeline
1. 2.
Market
Indication
Market size1
Infectious disease
Tuberculosis screening
>$1bn
Infectious disease
Lyme and other tick-borne diseases
$450m2
Infectious disease
Babesia blood screening
TBD
Transplant / Infectious disease
Cytomegalovirus
$150m
Transplant
Organ rejection
$300m
Multiple development programs in infectious disease, transplant, autoimmune & immune oncology
>$1bn
Estimated global market opportunity. Mid-point of ranges used (rounded) US only. OUS market not yet sized.
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Concept
Feasibility
Analytical Validation
Clinical Validation
Commercial Launch
Brand
TB Screening A major global market opportunity
• ~50M Latent TB Infection (LTBI) screening tests performed each year1 • >$1BN estimated market opportunity2
1 Diagnostics for Tuberculosis: Global Demand and Market Potential. WHO 2006 2 Company estimates based on current ASP and business model
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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
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 • Collectively these issues result in inefficient use of healthcare resources 8 Source: WHO. “Diagnostics for Tuberculosis” 2006
Market Replacing TST with IGRA Blood Tests •
Market adopting blood tests called interferon-gamma release assays (IGRAs) o o
•
Measure increased IFN-secretion by T cells previously exposed to M. tuberculosis Use purified M. tuberculosis-specific antigens, such as ESAT-6 & CFP10
IGRAs have several advantages over the TST o o o
Higher specificity (fewer false positives) No need for specifically trained healthcare workers No need for return visit
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Key Foundations for T-SPOT.TB Growth Established
Regulatory approval
Significant body of clinical evidence
Widespread guidelines recommendations
Widespread reimbursement
o o
o
o
o o o o
T-SPOT.TB approved in >50 countries worldwide, including US (FDA), Europe (CE mark), Japan (MHLW) and China (SFDA)
>450 publications in the peer-reviewed literature
IGRAs recommended in at least 34 countries worldwide including in US, Europe and Japan
Demonstrated cost-effectiveness Unique CPT1 code in US (Medicare at $103/test) >300m covered lives in the US Explicit reimbursement coverage in many other countries such as Japan, China and Germany
1. CPT is a registered trademark of the American Medical Association
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Significant Commercial Adoption With substantial headroom for further growth
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2004
CE mark (European approval)
2006
1st European guideline
2008
US FDA approval
2010
CDC guidelines issued in US Chinese SFDA approval
2011
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 Revised Japanese guidelines
2014
Opened market development office in China Hired salesforce in Japan
2015
Entered into US physicians office market segment Exceeded 300m covered lives in the US
2016
USPTF Grade “B” recommendation UK NHS Tender for new entrant screening Revised US guidelines (ATS/IDSA/CDC)
Global Commercial Channel Established Kit and service model
United States • Direct sales force in US o Principal call points: hospitals, public health, physicians offices
• Primarily selling our service offering
Europe & ROW
Asia
• Direct sales force in Europe o Principal call points: hospitals, public health, private labs o Distribution partners used in ROW
• Primarily selling our kit offering o
• Direct sales force in Japan o Principal call points: hospitals, private labs, rheumatology
• Direct presence in China o Market development office
• Selling our kit offering
Service in the UK
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Tick-borne Disease Franchise
•
Leading diagnostic lab specializing in tick-borne diseases
•
R&D company specializing in infectious disease
•
Principal product is proprietary C6 ELISA for the diagnosis of Lyme disease
•
Assays utilize proprietary techniques
•
Products supported by ~30 peer-reviewed publications
•
FDA cleared and CE marked, and product supported by >20 peer-reviewed publications
•
CLIA licensed and CAP accredited laboratory in the Boston area
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FDA inspected manufacturing space in the Boston area
•
~$11m revenues in 2015
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~$2m diagnostic revenues in 2015
•
Profitable
•
Profitable
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Tick-borne Pathogens Pose a Significant Health Risk Adverse health consequences
Ticks, especially at the nymph stage, are about the size of a poppy seed, making them exceedingly difficult to detect
Source: CDC, University of Rhode Island
Lyme Disease
• • • •
Chronic joint inflammation (Lyme arthritis) Facial palsy and neuropathy Cognitive defects Heart rhythm irregularities
Anaplasmosis
• • • •
Difficulty breathing Hemorrhage Renal failure, neurological problems Death (in rare cases)
Ehrlichiosis
• • •
Difficulty breathing Hemorrhage and bleeding disorders Death (in rare cases)
Babesiosis
• • • •
Low and unstable blood pressure Severe hemolytic anemia Malfunction of vital organs Death (in rare cases)
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The Spread of Lyme Disease Reported cases of Lyme Disease to the CDC, 2001 and 2014
•
There were ~5m specimens tested for Lyme disease in 2015
•
Large and growing market. Estimated US TAM: $400-$500m
Source: CDC, Oxford Immunotec analysis
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Importance of Other Tick-borne Infections Lyme disease
Anaplasmosis
Ehrlichiosis
Babesiosis
• Other common tick-borne pathogens are prevalent and are expanding • Other tick-borne pathogens can masquerade as Lyme disease, since symptoms are similar • Coinfection in endemic regions is common • It is important to test for more than just Lyme disease
Source: CDC
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Tick-Borne Disease Market Segments
Late presentation
Acute presentation
Unmet Needs / Opportunities
Our Solutions
More sensitive tests required in early detection
Imugen has proprietary immunological techniques to increase sensitivity in acute disease
Need to test for coinfections as well as Lyme
Imugen covers the major tick-borne diseases, and has coinfection data to educate market
Need for more sensitive, specific and cost-effective testing to replace or streamline two-step testing
Immunetics’ test can replace one or both of the current generic two-step tests with better performance
Tests needed that can indicate therapy response and/or cure
Imugen has proprietary tests and algorithm to stage disease; in addition, our pipeline is seeking to further augment our solution 17
Key Foundations for Growth Established
Regulatory approval
Differentiated, better performing tests
o o
o o
Imugen has multiple LDTs accredited by CLIA and CAP Immunetics has FDA & CE clearance for its C6 ELISA test
Both Imugen and Immunetics have differentiated tests with clear clinical advantages over current generic tests With both companies, we have broad coverage of market needs
Widespread reimbursement
Strong commercial channel
o
o o
Tests are covered under existing codes
Tick-borne diseases overlap well with our current TB call points and will leverage our current sales force in the US and OUS We can bring a strong voice to markets that are underserved and undereducated 18
Babesia as a Risk to the US Blood Supply = incidence prior to implementation of screening
= prior generations of screening
= incidence with current screening
Hepatitis B HIV Hepatitis C HTLV 1/2 West Nile Virus Babesia 1:10,000
1:100,000
Increasing risk Sources: FDA Blood Products Advisory Committee Meeting May 2015, Company analysis
1:1,000,000
Incidence rate
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Decreasing risk
Current Players in Screening Blood for Babesia Company
Serological Assay
Nucleic Acid Test (NAT)
AFIA – Lab service (under FDA review)
PCR – Lab service (under FDA review)
N.A.
ELISA – Kit (under FDA review)
“Screening for Babesia microti in the U.S. Blood Supply” New England Journal of Medicine 2016;275:2236-45
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Potential Market for Babesia Screening of Donor Blood After the FDA clears a blood screening assay, it typically issues guidance for its utilization with the donor blood screening industry. In May 2015, FDA’s Blood Products Advisory Committee (BPAC) convened and proposed the following recommendations for Babesia testing in donor blood. Endemic States: The committee voted to recommend year-round NAT testing (coupled with serological testing) in the 9 most endemic states = ~2m tests
All States (Endemic and non-Endemic): The committee voted to recommend year-round serological testing in all 50 states = ~13m tests
Note: Nine endemic states = NY, MA, ME, CT, RI, NJ, MN, WI, NH Sources: FDA BPAC meeting May 2015
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Transplant
• The Panel of Reactive T cells (PRT) test addresses T cell mediated organ rejection
• T-SPOT.CMV measures the strength of the T cell response against Cytomegalovirus (CMV) • CMV is a common viral pathogen: o
o o
Usually controlled by T cells, causes disease when T cell function is depressed
• Reducing rejection is critical to transplant outcomes:
• Major threat in transplants: o o
o
One of most common infections post-transplant CMV threatens the transplant patient and the transplanted organ
Rejection events shorten graft life & significantly increase costs
• Market size $300m1 • Expected launch Q3 2017
• Market size $150m1 • Expected launch Q1 2017
1. Estimated global market opportunity. Mid-point of ranges used (rounded)
Complements PRA test for antibody rejection Rejection can be both antibody and T cell mediated
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Financial Profile •
Strong revenue growth o o o
•
Multiple revenue growth drivers o o
•
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Seasonality in US and Japan Volatility in order patterns to distributors
Gross margins expanding o
•
Products: TB, Tick-borne disease, Blood banking, Transplant Geographies: US, China, Japan
Quarter-to-quarter revenue volatility o o
•
>20% annual CC revenue growth for 11 straight years Recurring revenue allows us to focus sales teams primarily on driving growth FY’16 guidance of $85.0-$85.8m (+35%-37% YoY)
33% in 2011 to 53% in 2015
Sound financial footing o
>$50m in cash at end of 2016
Key Priorities •
Continue our strong revenue growth o Continued penetration of T-SPOT.TB into the >$1bn TB screening market IGRAs only 15-20% penetrated
o Drive penetration of Imugen & Immunetics into the $450m tick-borne diseases market Use our commercial resources to expand the awareness of our differentiated offering
o Continue to add additional products to our sales force and CLIA lab infrastructure 2017 launch of blood banking tests for Babesia, and transplant tests Continue to add further products through R&D and M&A
•
Move company towards profitability o Increase gross margins o Drive leverage through operating expense
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Summary & Key Investment Highlights • Playing in large, growing, underserved markets • Proprietary, industry-leading products • Well developed, global commercial infrastructure • Diversified, recurring revenue streams • Strong revenue growth • Pathway to profitability
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