oxford immunotec · 2020. 11. 9. · 1 oxford immunotec global plc 94c innovation drive milton...

22
1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 www.oxfordimmunotec.com Oxford Immunotec Company Overview 3 rd November 2020

Upload: others

Post on 11-Jul-2021

9 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

1

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

Page 2: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

2

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.

Page 3: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

3

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

Page 4: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

4

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.

Page 5: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

5

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

Page 6: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

6

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.

Page 7: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

7

TB Screening: A Major Global Market Opportunity

Sources: Koncept Analytics, WHO

>70M Latent TB Infection

(LTBI) screening tests

performed each year

Page 8: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

8

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.

Page 9: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

9

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

Page 10: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

10

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

Page 11: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

11

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

+

+

Page 12: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

12

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

Page 13: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

13

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

+ =

Page 14: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

14

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

Page 15: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

15

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

Page 16: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

16

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

Page 17: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

17

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

Page 18: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

18

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

Page 19: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

19

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

Page 20: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

20

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

Page 21: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

21

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

Page 22: Oxford Immunotec · 2020. 11. 9. · 1 Oxford Immunotec Global PLC 94C Innovation Drive Milton Park, Abingdon Oxfordshire, OX14 4RZ, United Kingdom Company Number 08654254 Oxford

22

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