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Open Orphan #ORPH – Major year-on-year revenue growth and profitable H1 2021 performance following a year of turnaround and transition in 2020

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its unaudited interim results for the six months ended 30 June 2021. These results show a continued pattern of profitability from Q4 2020 to a firmly profitable position delivering a positive EBITDA profit of £2.1 million compared to an EBITDA loss of £4.1 million in H1 2020. We look forward to achieving record revenues in 2021 in our first full year of EBITDA profitability with recent contract wins and exceptional pipeline growth fueling revenues into 2022.

In the past 12 months, the Company has received international recognition and media attention for its excellence in delivering human challenge studies as a partner in the world’s first COVID-19 human challenge characterisation study. The Company now has a broad range of human challenge study models, focusing on leveraging the major growth opportunities presenting in infectious and respiratory disease markets, including RSV, Influenza, Asthma, hRV, COPD and Malaria.

Profitable Financial Performance in H1 2021:

  • Continuing from a profitable Q4 2020, the Company has moved the business to a firmly profitable position with losses consigned to the past
    • 242% reported revenue growth in H1 2021 (£21.9m) versus H1 2020 (£6.4m). Other income grew to £1.2m in H1 2021 from £0.7m in H1 2020
    • EBITDA profit of £2.1m (2020: EBITDA loss of £4.1m)
    • Revenue has more than tripled reflecting six active challenge studies in H1 2021 vs two active challenge studies in H1 2020 and a solid performance in Early Clinical / Biometry Services
    • In H1 2021, non-COVID-19 related work accounted for 75% of revenues
    • Gross margin has grown from 6% to 28% of revenue, reflecting that the Company is driving substantial operating leverage through cross selling, restructuring, functional integration and operational productivity
  • Cash and cash equivalents were £14.9m at 30 June 2021, primarily reflecting the operating cashflow cycle of the business with new contract prepayments expected in H2 2021
  • The Company has executed a share capital re-organisation as an important enabler to progress the monetisation of non-core assets via distribution of dividend in specie. In June, it completed the first distribution in specie back to the shareholders worth £26.2m at 16 September 2021, in relation to the demerging of certain non-core assets into Poolbeg Pharma Limited (“Poolbeg Pharma”)

 

Open Orphan Plc Group

(Results as Reported)

   
Unaudited

6 months ended

30 June 2021

Unaudited

6 months ended

30 June 2020

     
Income Statement £’000 £’000
Revenue (incl. other income) 23,166 7,078
Gross Profit 6,041 390
Operating Profit (Loss) after exceptional items 1,629 (6,340)
EBITDA before exceptional items 2,073 (4,145)

Operational highlights

  • Delivered a strong and growing pipeline of new challenge study contract wins across a broadening range of challenge studies including influenza, RSV, hRV, Asthma, etc. Strong growth from Big Pharma clients which will deliver revenues across H2 2021 and into FY 2022
  • Continued to diversify services offering and associated activities such as virus manufacturing and lab services enabled by CAP and UKAS accreditations which are progressing, as well as the development of new challenge study models (Malaria, COVID-19) as part of its broadening portfolio of challenge models
  • Leveraged its state-of-the-art facilities, including the new 19-bedroom quarantine facility (Whitechapel Clinic) beside the existing 24-bedroom Queen Mary’s BioEnterprises Centre facilities also in Whitechapel (QMB). All COVID-19 characterisation study activities conducted in the 19-bedroom quarantine facility in Royal Free Hospital in London. We have delivered a record volume of quarantine studies on an increasingly cost-efficient basis with ample capacity to further grow the business
  • Increased volunteer recruitment capacity through the opening of a new volunteer screening centre in Manchester and also a new dedicated street level screening facility in QMB increasing screening capacity to 520 visits per week
  • Disease in Motion® launched as a first step towards its spin off as a standalone company, with the intention that the value will be delivered to our shareholders via dividend in specie in the same format as was successfully completed with Poolbeg Pharma plc. This unique data-focused platform has multiple infectious disease applications for a wide variety of end users including big tech, wearables, pharma and biotech companies

Post-period end

  • Multiple high value human challenge study contracts signed – £5.7m Influenza study (September 2021), £8.1m asthma study (August 2021), significant hRV & Influenza study (July 2021)
  • Successful Phase 2a RSV human challenge studies completed for a top tier pharma company and for Bavarian Nordic highlight the value of human challenge studies, their role in mainstream clinical trial design, and hVIVO’s industry leading position
  • Successfully monetised the first non-core asset via spin-out and AIM IPO of Poolbeg Pharma plc through a dividend in specie to Open Orphan shareholders, which was non-dilutive to existing shareholdings in the Company
    • As of 16 September 2021, the Open Orphan shareholders’ value in Poolbeg Pharma plc is £26.2
    • Poolbeg Pharma raised £25m in fresh funds from new investors in an IPO in July 2021
    • Created substantial value for Open Orphan shareholders who received these dividend shares in Poolbeg Pharma with no income tax due as part of a HMRC approved statutory demerger
  • Additional 1.3m shares in Open Orphan, valued at £350,000, purchased by Company Directors (Cathal Friel and Prof. Brendan Buckley)

Outlook

  • Post-pandemic, the infectious and respiratory disease market is seeing exponential growth, with an expected global market value of $250bn by 2025. This is resulting in a vastly increased market for Open Orphan to test a new range of infectious and respiratory disease products as the world leader in the provision of human challenge studies
  • The Company is experiencing a major increase in negotiations, contract wins, and repeat contract wins with Big Pharma, while also seeing increased wins from biotech companies with major deals expected to now sign in Q4 2021 driving revenue in 2022
  • Open Orphan is expanding its focus and service offering in providing infectious and respiratory disease challenge studies
  • Full year guidance of c. £40m revenue (incl. other income) with full year EBITDA profitability for FY 2021, with non-COVID-19 work expected to represent c. 70% of FY 2021 revenue mix. While 2021 will represent record revenues for the Company and a return to full year EBITDA profitability, it is somewhat behind analyst expectations as the anticipated COVID-19 challenge studies will now likely commence in 2022 on foot of the successfully completed quarantine phase of the Human Challenge Programme characterisation study
  • Year-end cash balances expected to close in line with the half year position of £14.9m
  • Targeting revenues in the region of £50m for 2022 in non-COVID-19 work, reflecting signed contracts and contracts in advanced negotiations, ongoing momentum in the core business and ongoing market growth. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies
  • The Company continues to work towards the monetisation of all remaining non-core assets and to hand these back to Open Orphan shareholders via dividend in specie allowing the Company to focus on its core offering
    • These spin-offs / demergers offer an excellent opportunity for shareholders to maximise value in separate shareholdings in both exciting pharma product commercialisation companies, in addition to a profitable and world leading CRO
    • Opportunity to complete spin-off of Disease in Motion® platform along with plans to monetise the other non-core assets, namely the Company’s 62.6% stake in PrEP Biopharm, and 49% stake in Imutex Limited

Cathal Friel, Executive Chairman of Open Orphan plc commented:

Open Orphan has delivered very strong progress both operationally and financially. The Company’s H1 2021 revenues grew by 242% versus H1 2020, which continues a pattern of profitability from Q4 2020 and transitions the business to a firmly profitable position, having delivered a positive EBITDA profit of £2.1 million in H1 2021. The business is now well positioned to capitalise on the significant growth in the infectious disease market, which is expected to grow to in excess of $250bn by 2025 and we have seen our business development pipeline grow accordingly.

“I am delighted and hugely satisfied with the fantastic turnaround and team effort by everyone in the Open Orphan organisation; they have completely transformed the business following the acquisition of both hVIVO and Venn in the past two years. These two companies are now fully integrated and, in the process, we have created the world leader in the testing of vaccines, antivirals and other infectious and respiratory disease products using human challenge studies. With a broadening portfolio of human challenge studies, we are well placed to continue working with Big Pharma and biotechs alike to move their products through the clinic as the infectious disease market experiences one of the largest pharmaceutical growth cycles ever, with the market expected to grow significantly by 2025.  We look forward to further progress and a profitable H2 as the business continues to attract additional clients.

“Additionally, we will look to provide further shareholder value through the monetisation of our non-core assets, as we did post-year end with the successful spin-out, listing and distribution in specie of Poolbeg Pharma plc.”

Analyst Briefing

An online briefing for Analysts will be hosted by Cathal Friel, Executive Chairman, and Leo Toole, Group Chief Financial Officer, at 9.30am (BST) on 20 September 2021 to review the results and prospects. Analysts wishing to attend should contact Walbrook PR on openorphan@walbrookpr.com or on 020 7933 8780.

Investor presentation

OPEN ORPHAN PLC is pleased to announce that Cathal Friel and Leo Toole will also provide a live presentation relating to H1 2021 Interim Results via the Investor Meet Company platform on 20 September 2021 at 6:00pm (BST).

The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and add to meet OPEN ORPHAN PLC via:

https://www.investormeetcompany.com/open-orphan-plc/register-investor

Investors who already follow OPEN ORPHAN PLC on the Investor Meet Company platform will automatically be invited.

For further information please contact:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson/ Richard Chambers
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Louis Ashe-Jepson / Sam Allen +44 (0)7980 541 893 / 07747 515 393 / 07502 558 258

 

Notes to Editors 

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

LINK HERE FOR FULL FINANCIAL STATEMENTS

Open Orphan plc (ORPH) Demerger Update

Demerger Update

Further to Open Orphan’s announcement on 14 June 2021 in relation to the distribution in specie, the boards of Open Orphan and Poolbeg Pharma are pleased to announce Poolbeg’s intention to seek admission of its shares to trading on AIM, a market of the London Stock Exchange (“Admission”). Funds raised as part of Admission will be used primarily to fund the clinical trial costs associated with the development of the Company’s POLB 001 asset as a treatment for severe influenza and to acquire and develop new portfolio assets.

 

Wide asset portfolio

  • Attractive lead asset  POLB 001:
    • First-in-class, Phase II ready small molecule immunomodulator for severe influenza.
    • Addresses unmet need for effective treatments against severe influenza (c. $800m addressable market)
    • Applications beyond influenza are possible with label extensions (and the Company holds worldwide rights for all uses)
  • Vaccine Discovery Platform harnessing data from the human challenge model to potentially discover new vaccines which the Directors believe could generate significant shareholder value
  • PredictViral™ Biomarker platform for predicting severe disease – potential to transform the way infectious diseases are treated
  • Licensed access to one of the largest infectious disease progression data and bio banks i.e. Open Orphan’s data and biobank, with the potential to interrogate the data with an AI data analysis platform (advanced discussions underway) to accelerate the identification of drug targets / products
  • Pipeline of further assets for acquisition post-IPO

 

Infectious Disease Market

  • Market expected to exceed $250bn by 2025
  • Cumulative costs of the COVID-19 pandemic in terms of lost output & health reduction is equivalent to 90% of US GDP ($16tn)
  • Significant recent M&A and licensing activity in the infectious disease space

 

Capital light business model

  • Enables the Company to develop assets to Phase II quickly with relatively modest investment where they can potentially be monetised / licensed to big pharmaceutical companies
  • Platform for growth with a proven, streamlined method of identifying drugs to acquire / license, access to key data to drive that platform and well protected intellectual property
  • Faster and more cost-effective development model than traditional biotech’s giving potential for multiple value inflection points as each asset is advanced through the pipeline with a view to ultimate monetisation / licensing to big pharmaceutical companies
  • Intend to use contingent payments to fund asset acquisitions therefore minimising / eliminating potential equity dilution

 

Track Record

  • Strong heritage – initial assets from Open Orphan, a well-established, revenue generating business with over 20 years’ experience in infectious diseases and human challenge trials
  • Track record of delivery and creating value for shareholders – management team has completed three IPOs, built revenue generating businesses and achieved significant exits

 

Poolbeg IPO

  • Signal of quality to prospective partners and customers, raising the profile of the business
  • Provides a supportive platform on which to accelerate existing assets through development
  • Funds raised will allow the Company to acquire / license additional assets and technologies as appropriate
  • A portion of the Placing is expected to qualify for EIS and VCT related tax relief in addition to an expected retail offering via PrimaryBid
  • Cathal Friel, Non-Executive Chairman of Poolbeg has committed to participate in the IPO alongside incoming investors on the same terms

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

“The COVID-19 pandemic has placed the issue of infectious diseases firmly in the public eye; Governments and international organisations are now investing heavily to ensure they are better prepared.

“Poolbeg Pharma is aiming to carve out a leading position in this rapidly evolving and expanding sector. We have an excellent heritage in infectious diseases and a management team with a track record of delivering value creation.

“Our capital light business model is an important differentiator. Through deep biological analysis of disease progression, we believe that it should enable us to reposition existing drug candidates and develop assets to Phase II stage quickly with relatively modest investment where they can then potentially be acquired / licensed to big pharmaceutical companies. We aim to be customer-led and will use our extensive network to become a ‘one stop shop’ for big pharma, developing the assets that they need.”

 

Cathal Friel, Executive Chairman of Open Orphan and Non-Executive Chairman of Poolbeg Pharma commented:

“Poolbeg Pharma is a great opportunity to maximise the potential of some of Open Orphan’s pharma assets which are non-core to our successful human challenge clinical trial business in a focused and capital efficient way.

“Poolbeg’s approach to asset development should result in good licensing opportunities and excellent returns in a relatively short period of time with substantially less risk than the traditional biotech model and allow for regular investor newsflow. In addition, in Poolbeg we have assembled a leading management team, generated an exciting pipeline of potential acquisitions and entered advanced discussions with leading AI data analysis platforms to increase the attractiveness of the Company and its offering. Thus, I am confident and excited in the Company’s prospects going forward and will be personally investing alongside incoming investors as part of the potential IPO.

“We are extremely proud that this is now the third life science IPO from the Raglan Capital stable after Amryt Pharma plc and Open Orphan plc, and we are excited to have Jeremy Skillington joining as CEO, bringing his valuable experience and  successful track record with Inflazome to the team.”

– Ends –

 

Open Orphan plc

Cathal Friel, Executive Chairman

 

+353 (0) 1 644 0007

Arden Partners PLC (Nominated Adviser & Joint Broker)

John Llewellyn-Lloyd, Richard Johnson, Oscair McGrath

 

+44 (0) 207 614 5900

finnCap Ltd (Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson 

 

+44 (0) 20 7220 0500

Davy (Euronext Growth Adviser and Joint Broker)

Anthony Farrell

 

+353 (0) 1 679 6363

Walbrook PR (Financial PR & IR)

Paul McManus / Louis Ashe-Jepson / Sam Allen

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 

Open Orphan (ORPH) Final Results to 31 December 2020

Final Results to 31 December 2020

Important year of transition following the various merger and acquisition activities in 2019 and January 2020

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its audited results for the 12 months to 31 December 2020. Following the acquisition of hVIVO in January of last year, 2020 was a year of transition for the Company with management integrating both businesses and driving improvements in revenue, gross margin and efficient overheads.

This culminated in Q4 2020 proving to be an inflection point for the Company as it successfully generated both an operating profit and positive cashflow. In addition, the Company ended the year with a strong order book of contracted revenue which has been the foundation for the Company’s very strong start to 2021. In the context of the rapidly evolving COVID-19 pandemic and broader growth of the global infectious disease market, this should translate into very strong growth opportunities for the Company going forward.

Operational highlights:

  • Integration of hVIVO and Venn Life Sciences completed with pharmaceutical services business now profitable and poised for strong revenue and EBITDA growth in 2021; growing working capital balance on hand
  • Clearly established as the world leader in the testing of vaccines and antivirals through the use of human challenge study clinical trials
  • Strategy in place to maximise shareholder value via the demerger of non-core assets with first spin-out Poolbeg Pharma Ltd well under way
  • In the last 12 months substantially increased the number of quarantine beds available to Open Orphan:
    • Original 24 quarantine beds in Queen Mary’s BioEnterprises Centre (QMB) in Whitechapel
    • 19 bed additional beds through the conversion of the Whitechapel Hotel
  • Open Orphan has the capacity to screen in >500 volunteers per week to support a growing pipeline of human challenge studies.
    • New state-of-the-art volunteer recruitment screening centre on the ground floor of QMB
    • New standalone regional volunteer recruitment screening centre in Manchester
  • Strategic decision In March 2020 to develop a COVID-19 challenge model:
    • hVIVO was uniquely placed to contribute to a world-first initiative led by the UK government to work as part of the Vaccine Task Force’s Human Challenge project to manufacture a COVID-19 virus, and to collaborate on the design and delivery of a characterization study to understand how to use this virus for vaccine and anti-viral challenge trials, which is ongoing.
    • Collaboration is ongoing with significant progress achieved to enable the Group to test vaccines and therapeutics against COVID-19 in the near future.

Financial highlights

Open Orphan plc Group

(Results as Reported)

hVIVO Ltd

(Proforma results on a stand-alone basis for a full year)

 

Open Orphan plc

(formerly Venn Life Sciences Holdings plc – Proforma results on a stand-alone basis for a full year)

Open Orphan DAC

(Proforma results on a stand-alone basis for a full year)

Open Orphan plc Group

(Proforma results on a combined basis for a full year)

2020

2019

2020

2019

2020

2019

2020

2019

2020

2019

Income Statement

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

Revenue (Incl. other income)

21,995

3,543

14,515

15,092

7,844

8,643

22,359

23,735

Operating (Loss)

(10,442)

(5,130)

(4,854)

(5,893)

(5,604)

(6,385)

(435)

(669)

(10,893)

(12,948)

EBITDA before exceptional items

(6,265)

(3,792)

(2,925)

(3,785)

(3,313)

(4,432)

(431)

(668)

(6,669)

(8,885)

Loss for period

(10,791)

(5,739)

(4,927)

(6,973)

(5,776)

(6,622)

(548)

(899)

(11,251)

(14,494)

 

  • An important year of transition to reverse the proforma losses in 2019 by strengthening business development, restructuring underperforming businesses, driving cross group synergies, eliminating unnecessary layers of management, and integrating support functions across the Group.
  • Significantly improved track record of major contract wins in 2020 (versus 2019) setting the scene for strong revenue growth in 2021
  • Turnaround on track evidenced by an operating profit delivered for Q4 2020 and targeting full year profitability in 2021
  • Cashflow positive in Q4 2020 driven by advanced cash payments on major agreements.
  • Pharmaceutical services business (the combined business of Venn and hVIVO) is operationally profitable and moving into cash generation.
  • Well capitalized following two placings raising a combined total of £17.9m (before expenses)
  • Cash and cash equivalents of £15.1m as at 31 May 2021
  • Proforma revenues of £22.4m (2019: £23.7m), with losses reduced to £11.3m (2019: £14.5m)
  • Reported revenues of £22.0m (2019: £3.5m), with a reported loss for the period of £10.8m (2019: £5.7m)

Outlook:

  • Clinical Science Teams and Laboratory Development Teams continue to address ground-breaking research projects with major pharmaceutical players – strong demand for services expected.
  • Planned demerger strategy is progressing well with further update provided today on Poolbeg Pharma
  • Demergers offer an excellent opportunity for shareholders to maximise value through separate shareholdings in a profitable pharma services company as well as exciting pharma products commercialisation companies.
  • Opportunity to progress Disease in Motion® platform.
  • Targeting delivery of full year profit in 2021 – focusing on enhancing profits and earnings

Cathal Friel, Executive Chairman of Open Orphan plc commented: “The Group is not simply satisfied to have returned to a positive operating position at the end of 2020 and to be targeting to deliver a full year profit in 2021, it is now focused to further enhance the quality of profits and earnings of the Group going forward. Therefore, notwithstanding the strategic investments we are making in new challenge models and the Disease in Motion® platform, we will relentlessly focus on cross selling our services across our broad client base, leveraging technology to drive improved efficiencies, and stripping away unnecessary cost in our operations.”

“It has been a remarkable year and I am grateful to our team for their hard work and loyalty. I am also grateful to you, our shareholders for the faith you have placed in the Group. The new financial year has started well and is already very well advanced. We are confident that the actions we are taking now to drive our core CRO business and monetise non-core assets should create significant value for all our stakeholders.”

The Company’s Annual Report and Accounts for the year ended 31 December 2020 will be posted to shareholders in due course together with the notice of the 2021 Annual General Meeting], and will be available on the Company’s website,  https://www.openorphan.com/

Analyst Briefing

An online briefing for Analysts will be hosted by Cathal Friel, Executive Chairman, and Leo Toole, Group Financial Officer, at 11.00am on Thursday 17 June 2021 to review the results and prospects. Analysts wishing to attend should contact Walbrook PR on openorphan@walbrookpr.com or on 020 7933 8780.

Investor presentation

OPEN ORPHAN PLC is pleased to announce that Cathal Friel and Leo Toole will also provide a live presentation relating to Final Results 2020 via the Investor Meet Company platform on 17th Jun 2021 at 6:00pm BST.

The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and add to meet OPEN ORPHAN PLC via:

https://www.investormeetcompany.com/open-orphan-plc/register-investor

Investors who already follow OPEN ORPHAN PLC on the Investor Meet Company platform will automatically be invited.

For further information please contact:

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus Louis Ashe-Jepson / Sam Allen

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258  

Open Orphan (ORPH) Investor Presentation June 2021

Open Orphan (ORPH) Investor Presentation June 2021.

Open Orphan PLC #ORPH – Result of General Meeting

Result of General Meeting

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials , announces that all resolutions proposed at the General Meeting held earlier today were duly passed.

Further announcements regarding the proposed Distribution in Specie will be made in due course.

For further information, please contact:

Open Orphan plc

www.openorphan.com

Cathal Friel, Executive Chairman

+353 (0) 1 644 0007 

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Nick Wright

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus / Sam Allen /

Lianne Cawthorne

+44 (0)7980 541 893 / +44 (0)7748 651 727 /

+44 (0)7584 391 303

Open Orphan PLC #ORPH – Venn Life Sciences contract wins

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce its subsidiary Venn Life Sciences (“Venn”) has been awarded two new contracts.

The first contract, which will commence immediately, is a COVID-19 study for a European pharmaceutical company which involves 200 patients in 50 sites across 5 countries around the world. Venn’s Paris team will manage the randomisation and supply management for this randomised, double-blind, placebo-controlled Phase 2 Clinical Trial to evaluate the safety and efficacy of a combination treatment of two drugs, and the best supportive care for patients with moderate and severe COVID-19 in a hospitalised setting.

Venn’s team based in the Breda office, in the Netherlands has also signed a contract with a European pharmaceutical company. The contract will see Venn assist with project management, design and implementation of new processes related to clinical development and use its expertise to deliver process improvement. The contract, which starts immediately, will run until December 2021 delivering significant revenues for Venn.

This contract builds on Venn’s existing relationship with this European pharmaceutical company whom Venn currently provides a variety of services to including IMPD writing, regulatory briefing book writing, preclinical and clinical consultancy.

Cathal Friel, Executive Chairman, Open Orphan, said:

“As we come towards the end of 2020, it’s wonderful to see all the elements of the Open Orphan business are delivering substantial revenues and both new contract wins and renewal of existing long-term customer contracts. The merger and integration of Open Orphan, Venn and hVIVO is very much now complete, and having become profitable in Q4 2020, we now have a very valuable, fast growing and secure business on our hands. Both Venn and hVIVO are converting their substantial pipeline of work whilst providing a high-quality service to their customers. The Paris team’s contract is a further demonstration of our work in the fight against COVID-19 and the contract win by our Dutch Breda team shows how we continue to generate repeat business through our expertise.

I am very excited by the momentum in the business and look forward to providing further updates in the weeks and months ahead of what is going to be a very exciting 2021″.

 

ENDS

Interested in becoming a volunteer?

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at  www.UKCovidChallenge.com .

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

 Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com.

For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

 

LinkedIn/Facebook:

#ORPH @OpenOrphanplc subsidiary @VennLifeSciences contract wins

~ The first contract is a #COVID19 Phase 2 Clinical trial involving 200 patients in 50 sites across 5 countries.

~ The second contract will see #Venn assist a project related to clinical development, delivering significant revenues and running until Dec 2021.

~ Cathal Friel “I am very excited by the momentum in the business and look forward to providing further updates”

#pharma #testing #placebo

Open Orphan PLC #ORPH – Venn Life Sciences contract wins (branduk.net)

Twitter:

#ORPH @OpenOrphan @VennLifeScience contract wins:
 
~ #COVID19 Phase 2 #Clinicaltrial involving 200 patients
 
~ #Venn to assist clinical development project, delivering significant revenue
 
#lifesciences
 
Open Orphan PLC #ORPH – Venn Life Sciences contract wins (branduk.net)
Vox:
#ORPH Open Orphan plc subsidiary Venn Life Science contract wins:
~ COVID19 Phase 2 Clinical trial involving 200 patients
~ Venn to assist clinical development project, delivering significant revenue

Open Orphan #ORPH – Major New Contract Win for Venn Life Sciences

Open Orphan plc (ORPH) a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models, is pleased to announce that it has signed a major contract with a leading vaccine developer and one of the top pharmaceutical companies in the world.

The contract with Venn Life Sciences, which is part of Open Orphan, builds on earlier successful contracts between the companies and is to obtain and support market access of newly developed vaccines into the EU and US markets until the end of 2020.

The contact demonstrates Venn Life Sciences’ ability to service leading vaccine developers which in turn benefits hVIVO, also part of Open Orphan, as cross-selling opportunities arise. The contract demonstrates Venn Life Sciences’ unique combination of drug development expertise, clinical trial design and execution services.

This fits with Open Orphan’s strategic aim of becoming a leading pharma services provider globally with particular expertise across the Company in providing services to the rapidly growing vaccines industry.

Cathal Friel, Executive Chairman of Open Orphan, commented:

“We are delighted to have signed this contract with a leading vaccine developer and one of the top pharmaceutical companies in the world. This contract reinforces Open Orphan’s position as one of the leading service providers to the vaccine industry globally. As a result of the Covid-19 pandemic, the vaccine industry is now an increasingly important and rapidly growing sector with many large pharmaceutical companies now directing huge amounts of resources towards their vaccine divisions to progress both Covid-19 and non-Covid-19 vaccines. Open Orphan is ideally positioned to capitalise upon this trend as we build the Company into a growing, profitable pharmaceutical services business.”

For further information please contact

Open Orphan plc

Cathal Friel, Executive Chairman

+353 (0)1 644 0007

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

finnCap Ltd (Joint Broker)

+44 (0)20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. Which offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.

Open Orphan comprises of two commercial specialist CRO services businesses (hVIVO and Venn) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

Alan Green CEO of Brand Communications talks about: i3 Energy #I3E Cranswick #CWK Tertiary Minerals #TYM Open Orphan #ORPH

(Interview starts at 12 minutes 20 seconds)

Open Orphan (ORPH) – CRUX Asset Management Ltd increase Holding(s) in Company

TR-1: Standard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

Open Orphan PLC

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligationiv

Name

CRUX Asset Management Ltd

City and country of registered office (if applicable)

London, UK

4. Full name of shareholder(s) (if different from 3.)v

Name

FP CRUX UXITS OEIC

City and country of registered office (if applicable)

London, UK

5. Date on which the threshold was crossed or reachedvi:

30/09/2019

6. Date on which issuer notified (DD/MM/YYYY):

01/10/2019

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights of issuervii

Resulting situation on the date on which threshold was crossed or reached

4.10%

0%

4.10%

10,428,571

Position of previous notification (if

applicable)

3.52%

N/A

3.52%

8,928,571

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

GB00B9275X97

10,428,571

4.10%

SUBTOTAL 8. A

10,428,571

4.10%

 

 

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

 

 

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period 
xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii

X

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity
xiv (please add additional rows as necessary)

Namexv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional informationxvi

Place of completion

London, UK

Date of completion

01/10/2019

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

END

Alan Green CEO of Brand Communications talks about: Thomas Cook CVS Group #CVS Open Orphan #ORPH Bidstack #BIDS IMC Exploration #IMCP

Alan Green CEO of Brand Communications talks about: Thomas Cook CVS Group #CVS Open Orphan #ORPH Bidstack #BIDS IMC Exploration #IMCP
(Interview starts at 14 minutes 27 seconds)
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