Annual Report and Accounts

For the year ended December 2019

Contents3

Contents

01

Business Overview

04

Who are we?

05

Our strategy

06

Our market

07

Highlights

08

Group figures

12

02

Strategic Report

14

Chairman's statement

14

Chief Executive Officer's review

16

Post-period: Development of new coronavirus (COVID-19) test

20

Our divisions

22

Financial review

24

03

Governance

28

The Board of Directors

28

Executive Team

33

Directors' report

34

An introduction from the Chairman

38

QCA Principles

39

Nomination Committee report

49

Directors' Remuneration Report

50

Audit Committee Report

56

Principal Risks and Risk Management

60

04

Financial Statements

68

Statement of Directors' responsibilities in respect of the annual

68

report and financial statements

Statutory auditor's report on the consolidated financial statements

70

05

Accounts and Notes

72

Consolidated income statement

73

Consolidated statement of comprehensive income

73

Statement of financial position

74

Statement of changes in equity

75

Statement of cash flows

76

Notes to the annual accounts

77

06

Company Information

128

01

Business Overview

Novacyt is a rapidly growing, international diagnostics group, generating revenues from the sale of diagnostic and pathogen testing kits based on molecular and protein testing technologies and sold into human clinical, life science, food and industrial markets.

Business Overview5

Who are we?

Novacyt is focused on developing, manufacturing and commercialising niche clinical diagnostic products to serve the infectious disease market representing the largest segment of the clinical diagnostics market.

Novacyt has a broad product range which is accredited and registered in over 100 countries and has two main product technology platforms which underpin its product portfolio and niche market focus. The two technology platforms are molecular-based products (the fastest growing technology sector) and protein-based diagnostic products (the largest and most established technology sector).

The Company's customers and end-users include universities, hospitals, clinics and testing laboratories

(both with healthcare and industrial focus). In markets such as the UK, the Company sells to end-users through its direct sales workforce, whilst in the majority of markets they are reached through an extensive overseas distributor and OEM partner network.

01Business Overview

Our strategy

Our market

The business is focused on three strategic pillars of growth:

  • 1. Organic Growth

  • 2. Innovative R&D

  • 3. Acquisition

Academic research is the first step in the life sciences continuum where significant new research is taking place tounderstand the genetic nature of disease. Novacyt, through its innovative molecular product range, generates revenues from supporting academic researchers with its ability toquickly develop and supply specific DNA and RNA kits forresearch use. This market requires products developed as Research Use Only (RUO) and does not require the extensive clinical validation necessary for clinical markets. This is a large and important market for Novacyt and currently underpins the core growth of the molecular productrange, notwithstanding the effect of COVID-19 on sales experienced in the first half of 2020.

The Company's largest target market is clinical diagnostics where its tests are developed and validated to the standards required for human clinical use. Where appropriate, we also look to utilise the same technologies and products for application in veterinary diagnostics. A critical component of improved clinical care in food and veterinary diagnostics is the accurate diagnosis not only of the disease, but the genetic diagnosis underlying the disease state.

The regulatory accreditations required for these products provide high barriers to entry and include the CE-Mark for many European and international markets, the CFDA for China and the FDA for the US market. Examples of the segments Novacyt's products are usedin include syphilis, MRSA, C-Diff and, most recently,coronavirus (COVID-19).

Another key market for some of Novacyt's products is food testing, which is an increasingly stringent market as food safety becomes more important. Novacyt has some market-leading products used in food testing such as Listeria, Salmonella, Campylobacter, E-coli and other bacterial and fungal pathogens.

We have identified specific growth opportunities in thelarge, fast-growing but fragmented diagnostics market, particularly for the molecular products of Primerdesign, whilst also seeking to strengthen demand for the established protein products of Lab21.

Molecular diagnostics market

The Company estimate that Primerdesign's core target molecular markets for RUO, IVD clinical and food pathogen testing are worth approximately €14.7bn per annum, with an estimated growth of over 4.3% per annum. The RUO market, alone, is estimated to be worth €1.3bn with the clinical market estimated at over €6.0bn.

Protein diagnostics market

Lab21 operates in an estimated €11.7bn total addressablemarket with a specific focus in microbiology, serology andhaematology diagnostic markets.

Novacyt competes in these established markets by offeringgood quality, high performing reagent products with long recognisable brands.

Primerdesign's core target molecular markets for RUO, IVD clinical and food pathogen testing are worth approximately

€14.7bn

€11.7bn

Estimated total addressable market Lab21 operates in witha specific focus in microbiology,serology and haematology diagnostic markets

01Business Overview

Highlights

COVID-19

The rapid execution of our emergency product process in response to the outbreak in Wuhan meant

Primerdesign was able to release one of the world's first qPCR detection assays, and be the first for causing the specific SARS-CoV2 the SARS-Cov2 virus responsiblefor causing COVID-19. The subsequent CE approvalmade it the first product in the world (outside of China) to be fit for clinical use in the diagnosis of disease.

Launch of multiple Infectious Disease parameters in Microgen Bioproducts with PathFlow™

As part of Novacyt's ongoing efforts to develop cost-effective and accurate diagnostic productsthat will deliver the fastest and most reliable results possible, Microgen Bioproducts expanded its rangeof PathFlow™ lateral flow assays with the launch ofsix additional infectious disease parameters including

Clostridium difficile, Helicobacter pylori and a rapid alternative for Influenza testing.

New molecular respiratory panel ready for the US market

The introduction of a Primerdesign-developed respiratory panel for use in the US represents one of our biggest B2B business transactions to date, and highlights the capacity ofour scientific and production teams in offering fit-for-purposesolutions to any qPCR market demand.

Next Gen QPCR Instrument Q32

The q32 was the evolution in Primerdesign's instrumentationoffering to users of real-time amplification technology.

Boasting higher throughput and potentially shorter run times,it offers a powerful solution to new users and customerswishing to upgrade capacity from the original q16.

Immunexpress partnership

Our longstanding relationship with Immunexpress has led to our Primerdesign business providing research and development activities for seven separate projects.

These projects have delivered significant benefits to the development of Immunexpress product offerings.

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Novacyt SA published this content on 29 June 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 June 2020 07:43:01 UTC