RE2021POL RTANN PLCUA ORPHAN N OP E
Open Orphan plc
ANNUAL REPORT
FOR THE YEAR ENDED 31 DECEMBER 2021
Our Vision
World leader in testing
infectious & respiratory disease products using human challenge studies addressing the growing infectious disease market
Open Orphan Plc
STRATEGIC REPORT | CORPORATE GOVERNANCE | FINANCIAL STATEMENTS | 1 |
Contents
Executive Chairman's Statement | 2 |
Chief Executive Officer's Statement | 4 |
The Board | 8 |
Strategic Report | 10 |
Report of the Directors | 12 |
Corporate Governance Statement | 16 |
Report of the Remuneration Committee | 19 |
Independent Auditor's Report | 20 |
Consolidated Statement of Comprehensive | |
Income Statement | 31 |
Consolidated and Company's Statement of | |
Financial Position | 32 |
Consolidated and Company's Statement of | |
Changes in Shareholders' Equity | 33 |
Consolidated and Company's Statement of | |
Cash Flows | 34 |
Notes to the Financial Statements | 35 |
Company Information | ibc |
Group subsidiaries and associates:
Annual Report and Accounts / 31 December 2021
2
Executive Chairman's Statement
For the year ended 31 December 2021
Introduction
I am pleased to report on trading for the year ended 31 December 2021, a period in which we continued our strong momentum. The Group reported substantial revenue growth of 76%, with total revenue (incl. other income) of £39.0m (2020: £22.2m), and more importantly a transition to positive EBITDA of £2.9m (2020: £(6.1)m). 2021 was also a year of considerable operational progress; the Group conducted a record number of human challenge trials and successfully completed the spinoff of Poolbeg Pharma plc, which listed on the London Stock Exchange in July 2021, giving our shareholders a stake in Poolbeg Pharma plc through the distribution in specie shares.
In the two years since we acquired hVIVO, we have transformed the way that it runs human challenge trials by both reducing the time taken to complete a study, from 18 months to six months, and substantially increasing the Company's capacity and
capability to run more studies; increasing our total quarantine capacity to 62 beds. In addition, we have focused on expanding the Company's human challenge trials to include nonviral disease indications such as asthma, and by making new challenge models available to our clients, including COVID19 and malaria.
Furthermore, as a result of the pandemic, hVIVO and the UK received worldwide recognition as a world centre for conducting human challenge trials. This was a direct result of successfully completing the world's first COVID19 human challenge trial midpandemic. The pandemic also highlighted the significant value of human challenge trials which provide human efficacy data in a fraction of the time and cost it would take to complete a normal field trial. As a result of these initiatives, the global market for human challenge trials has increased significantly and as the world leader in the provision of these studies, we expect the business to deliver an increasing number of challenge trials year on year going forward.
Strategic delivery 2021
Below is an outline of the Group's achievements in 2021 across key business revenue streams and market trends.
Human challenge / clinical services
2021 was a record year for hVIVO's core human challenge trial business, with the Company delivering a strong and growing pipeline of challenge study contract wins across our world leading portfolio of human challenge models. The Company is benefitting from a significantly expanded market for infectious and respiratory disease products, with four of the top 10 global biopharma companies working with us in 2021.
In 2021 we successfully collaborated with a client who funded the rapid and costefficient conversion of the unoccupied Whitechapel Hotel located
immediately beside our existing QMB facility, into the Whitechapel Clinic, a 19bedroom quarantine clinic. Following the successful delivery of this trial to the client, we continue to operate the Whitechapel Clinic for challenge trials. This expanded our existing quarantine bedroom capacity to 43 (which was subsequently increased postperiod end, providing us with access to 62 beds).
We also converted a vacant lot adjacent to the existing QMB facility into a new FluCamp volunteer recruitment screening centre. Similarly, we expanded our FluCamp screening facilities with the opening of new facilities in Manchester. These projects were completed at minimal cost and the expansion enabled us to screen 84,000 volunteers for human challenge studies in 2021.
COVID19
2021 was a pivotal year for the UK and its attempt to emerge from the COVID 19 pandemic, and I was proud of the significant contribution that our team made to this. As a commitment to help the UK government to fight the pandemic, the team at hVIVO worked tirelessly under difficult conditions in the midst of a pandemic, to deliver a COVID19 characterisation study to provide unique insights into COVID19. The results of the study were published in the peer reviewed scientific journal 'Nature Medicine' in February 2022. It is a testament to the hVIVO team and their knowledge and commitment that this study was completed safely and in a timely manner. The study was conducted in partnership with the UK Government's Vaccine Taskforce and Department of Health and Social Care (DHSC), Imperial College London and the Royal Free London NHS Foundation
Open Orphan Plc
STRATEGIC REPORT | CORPORATE GOVERNANCE | FINANCIAL STATEMENTS | 3 |
Trust. Additionally, we were contracted to manufacture a SARSCoV2 Delta variant challenge agent with Imperial College London, as part of a Wellcome Trustfunded initiative.
The extensive worldwide coverage we received as part of this work raised Open Orphan's profile as the world leader in conducting human challenge trials and highlighted the significant benefit of these studies to deliver critical human efficacy data.
While effective vaccines and antiviral treatments have lessened the impact of COVID19 infection in human populations, the lasting legacy of the pandemic is a significantly enlarged infectious and respiratory disease market, which is expected to grow to in excess of $250bn by 2025. The Group is leveraging this significant market growth. With extensive relationships across the industry, a world class reputation, and an ability to continue enhancing and diversifying its offering, the Group is well placed to secure further work as a result of this renewed investment and focus on respiratory diseases.
Board changes
We strengthened our Board with the appointment of Yamin 'Mo' Khan, initially as NonExecutive Director on 13 October 2021 before he was subsequently appointed CEO, post period end, on 24 February 2022. Mo brings 25 years of CRO experience to his role, and I have thoroughly enjoyed working with him since he joined the Group. Mo has had a significant impact on the business, and we were delighted that he since accepted the position of CEO. Mo brings extensive industry specific insights that we will leverage to deliver on our expanding pipeline of opportunities, and I am confident Mo
will continue to drive the Group's upward trajectory.
In July 2021, Professor Brendan Buckley, NonExecutive Director, and myself collectively purchased a further 1,320,754 ordinary shares at 26.5 pence per ordinary share, which increased my shareholding to 7.0% and Brendan's shareholding to 1.2% of the Company's issued ordinary share capital. I hope this demonstrates to our shareholders the Board's commitment to the business and our desire to drive shareholder value to match our considerable financial and operational growth and momentum.
In April 2022, we appointed Liberum Capital Limited as our Nominated Adviser and Joint Broker. We are delighted to be working with Liberum which is ideally placed to introduce Open Orphan's fast growing, profitable and sustainable business to new investors.
Summary
In a pandemichit 2021, the Group achieved record revenues, transitioned to making an EBITDA profit, and made significant operational progress. The business conducted a record number of human challenge trials, and has established itself as the worldleading provider of human challenge trials in the rapidly expanding infectious and respiratory disease market. Our work in COVID19 enabled us to demonstrate our unparalleled expertise to a wider audience, and the market is now clearly recognising the value that human challenge trials can offer.
The business is firmly profitable and remains well capitalised with a cash balance of £15.7m to help drive the business forward and to realise further value for our shareholders. I would like to thank all of our employees for their
incredible efforts this year, and our shareholders for their continued support.
Cathal Friel
Executive Chairman
6 June 2022
Annual Report and Accounts / 31 December 2021
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Open Orphan plc published this content on 08 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 June 2022 09:11:10 UTC.