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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.

Open Orphan #ORPH – Interim Results for 6 months ended 30 June 2019

Open Orphan, a European-focused, rare and orphan drug consulting services platform, announces its interim results for the six months ended 30 June 2019. Financial Highlights below (and in note 3 of the reported financial statements) reflect the interim results of Venn Life Sciences (“Venn”) prior to the reverse takeover by Open Orphan on the 28 June 2019.

Reported results, based on IFRS accounting rules, reflect those of Open Orphan DAC while the Balance Sheet as of end June 2019 reflects that of the combined group with share capital reflecting the position of the ultimate parent Company Open Orphan Plc.

Financial Highlights:

·      Placing of GBP £4.5 m in June 2019 to recapitalise the business and fund the growth strategy

·      Revenue of €5.8m (Venn HY18: €7.8m)

·      EBITDA Loss of -€1.5m (Venn HY18 EBITDA profit: €0.2m)

·      Operating Loss of -€1.8m (Venn HY18 Operating Loss: -€0.6m)

·        Cash and cash equivalents of €5.1m at period end following successful placing

·      Post completion of reverse takeover, continued reduction in overheads delivering cost efficiencies

o  Increased staff utilisation

o  Strong pipeline of potential work

o  Targeting profitable growth and a return to profitability in 2020

Operational Highlights:

·      Transformational reverse takeover of Venn Life Sciences Holdings Plc by Open Orphan DAC

o  The Enlarged Group intends to target the fragmented orphan drug services market in Europe

o  Identified an extensive pipeline of target acquisitions primarily in the regulatory approval, reimbursement and product launch

·      Venn being successfully right-sized with reductions in overheads and in the cash burn rate

·      Open Orphan Services continues to develop a pipeline of acquisitions to complement our current offering and has an ambition to complete an acquisition before the year end

·      Development of the Open Orphan Genomic Health Data platform targeting patient advocacy groups to help source rare disease patient genomic data – companies approached, and early adopters expected to be announced in the second half of the year.

·      Open Orphan’s second digital data platform is advancing and building a platform for growth

Cathal Friel, CEO of Open Orphan, said:

“The combination of Venn and Open Orphan has given us a strong platform to build a full-service, high margin consultancy to offer services to the fast-growing orphan drug market right across Europe. We have a strong management team with a proven track record and an experienced board which will work closely alongside us.

We are well positioned for future growth and there a number of reasons for the team and shareholders to be excited as we look into the future.” 

Conference call for sell-side analysts and investors

The Company will hold a conference call for sell-side analysts and investors at 10am today hosted by: Cathal Friel, CEO and Maurice Treacy, CCO.

Participant dial-in numbers

Dial in number

Access PIN

United Kingdom Toll-Free: 08003589473

35437628#

United Kingdom Toll: +44 3333000804

35437628#

Republic of Ireland Toll: +353 14311252

35437628#

Republic of Ireland Toll-Free: 1800948241

35437628#

URL for international dial in numbers: http://events.arkadin.com/ev/docs/NE_W2_TF_Events_International_Access_List.pdf

 

Enquiries:

Open Orphan Plc Tel: +353 (0)1 644 0007

Cathal Friel, Chief Executive Officer

Arden Partners (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7614 5900

John Llewellyn-Lloyd / Ruari McGirr / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker) Tel: +353 (0)1 679 6363

Anthony Farrell (Corporate Finance)

Camarco (Financial PR) Tel: +44 (0)20 3757 4980

Tom Huddart / Billy Clegg / Daniel Sherwen

 

Notes to Editors:

Open Orphan plc is a European-focused, rare and orphan drug consulting services platform. The Company intends to roll up a number of orphan drug services business. Open Orphan has two data driven digital platforms, a Genomic Health Data Platform, which is establishing a rare disease database and a Virtual Rep platform enabling pharmaceutical companies to engage key opinion leaders and physicians. The Company is targeting rapid growth in one of the fastest growing sectors in the global pharmaceutical industry targeting under-supplied treatment for life threatening or very serious diseases and rare disorders.

Chairman’s Statement

Introduction

The first half of 2019 saw the transformational reverse takeover of Venn Life Sciences Holdings Plc by Open Orphan DAC to target the fragmented orphan drug services market in Europe. As part of the reverse takeover Open Orphan successfully completed a placing, raising GBP£4.5 million to recapitalise the business and fund our growth strategy.

Financial Results

The reported interim results reflect the six months of Open Orphan DAC following its reverse takeover of Venn Life Sciences Holdings Plc prior to its reverse takeover by Open Orphan on the 28th June 2019.

The results of Open Orphan Plc (on a stand-alone basis and excluding any impact of the 28 June 2019 combination per notes 1 & 3 below) reflect service fee income for the first six months of 2019 of €5.8m (H1 2018: €7.8m). EBITDA for the period was -€1.5m (H1 2018: €0.2m).

On a reported basis reflecting IFRS accounting rules for reverse acquisitions, service fee income for the first six months of 2019 was €0.0m (H1 2018: €0.0m). EBITDA for the period was -€0.2m (H12018: -€0.5m). Cash and cash equivalents at the end of the period were €5.1m (H12018: €0.6m).

In June, Open Orphan successfully completed a placing, raising GBP£4.5 million. The placing positions the Company to take full advantage of the platform created from the combination of Venn Life Sciences and Open Orphan. The Company has continued to carefully manage its cash reserves and the placing allows the management team, who have a strong track record, to realise the full potential of the enlarged group.

Operational Review

Open Orphan was founded in July 2017 with a strategy and product offering to develop a market leading services platform for pharmaceutical and biotechnology companies seeking to commercialise their products across Europe with a particular focus on drugs treating rare diseases.

The reverse takeover of Venn by Open Orphan was the first step in Open Orphan Services strategy of consolidating the European orphan pharma services business. The orphan drug consulting space in Europe is highly fragmented and consists of many small players scattered across Europe. It is Open Orphan’s plan to acquire a number of these smaller players, consolidating them into the leading orphan drug consultancy services company in Europe. Open Orphan continues to have a pipeline of potential acquisitions and has an ambition to complete an acquisition before the year end.

Venn has historically been loss-making due to its under-utilisation of staff. Post-completion of the reverse takeover on the 28th of June, the Directors have undertaken initiatives to resolve staff under-utilisation and increase operational efficiency. In addition, overheads, including the excessive office space and office facilities, are being  significantly reduced through the leasing of surplus office space through sublets to third parties. Furthermore, the cash burn rate has been significantly reduced through a clear strategic focus on operational efficiencies. The action taken to make Venn more efficient is expected to result in growth and return to profitability in 2020.

Since the reverse takeover, Open Orphan has created two digital data access platforms. The aim of Open Orphan’s digital platforms is to develop, in a low-cost manner, one of Europe’s largest databases of rare disease patients. The first platform compiles details of over 4,000 physicians and KOLs across Europe with a focus on orphan drugs.

The Genomic Health Data Platform has identified and begun establishing a patient health data platform, with a focus on orphan diseases. This is intended to be established in partnership with a number of patient advocacy groups on a revenue share basis to encourage patients with rare and orphan conditions to share their health data. In the second half of the year, it is the ambition of Open Orphan to bring onboard early adopter pharmaceutical companies and early adopter patient advocacy groups to the platform to help the Company source patient genomic data with the Company encouraged by early feedback.

The Open Orphan Virtual Rep platform enables pharmaceutical companies to engage over 4,000 key opinion leaders and physicians across Europe with a focus on orphan drugs. In due course, the platform will enable Open Orphan to promote client services to its extensive list of key opinion leaders and physicians/

In June, we were pleased to appoint Maurice Treacy as an Executive Director of the Company and subsequently Chief Commercial Officer. Maurice was most recently a founder of HiberGen and one of the founders of Genomics Medicine Ireland, which was recently acquired by WuXI NextCODE. Post period end, David Kelly was appointed as an Independent Non-Executive Director. David has extensive orphan drug company experience both in Europe and in the USA. He was Executive Vice President and Managing Director of Ireland at Horizon Therapeutics plc, a biopharmaceutical company listed on Nasdaq and headquartered in Dublin.

As noted in the Admission Document the Company is undertaking an active search for a CFO to join the Board. Post the period end the Company has appointed Leo Toole as Interim CFO. Leo will lead the finance function. The Board expects to make an appointment of a permanent CFO to the Board by the end of the year.

Outlook

We have a clear growth strategy targeting the fast-growing market for orphan drugs. The management team and Board have a strong track record and we are confident in our abilities to generate significant shareholder returns. We look forward to updating our shareholders on the exciting acquisition pipeline, the signing up of early adopter pharmaceutical companies and early adopter patient advocacy groups to the Genomic Health Data platform and our growth in the fragmented orphan drug services market in Europe.

Brendan Buckley

Chairman

25 September 2019

  

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2019

 

Unaudited

Unaudited

Audited

6 months ended

6 months ended

18 July 2017 to

30 June

30 June

31 December

2019

2018

2018

€’000

€’000

€’000

Continuing operations

Revenue

Administrative expenses

(179)

(451)

(1,611)

Operating (loss)/profit

(179)

(451)

(1,611)

  Depreciation and amortisation

EBITDA before exceptional items

(179)

(451)

(1,611)

Reverse Acquisition Cost

(796)

Finance income

Finance costs

(250)

(12)

(45)

Loss before income tax

(1,225)

(463)

(1,656)

Income tax credit

Loss for the period

(1,225)

(463)

(1,656)

Loss attributable

Owners of the parent

(1,225)

(463)

(1,656)

Loss for the period

(1,225)

(463)

(1,656)

Currency translation differences

Total comprehensive loss for the period

(1,225)

(463)

(1,656)

 

 

 

 

 

 

Earnings per share from continuing operations attributable to the owners of the parent during the period (see note 2)

 

Basic and diluted (loss) per ordinary share

€ Cent

€ Cent

€ Cent

From continuing operations

(1.65)

(219.73)

(785.29)

From (loss) for the year

(1.65)

(219.73)

(785.29)

Consolidated Statement of Financial Position

As at 30 June 2019

 

Unaudited

Unaudited

Audited

As at

As at

As at

30 June

30 June

31 December

2019

2018

2018

€’000

€’000

€’000

Assets

Non-current assets

Property, plant and equipment

266

1

Intangible assets

3,758

Right-of-use leased assets

1,808

Investments

31

Total non-current assets

5,863

1

Current assets

Trade and other receivables

5,669

46

36

Income tax recoverable

10

Assets held for sale

702

Cash and cash equivalents

5,070

583

165

Total current assets

11,451

629

201

Total assets

17,314

629

202

Equity attributable to owners

Share capital

371

Share premium account

18,973

Group re-organisation reserve

(541)

Reverse acquisition reserve

(7,621)

Share Option and Warrant Reserve

238

Other reserve

(34)

Foreign currency reserves

(44)

Retained earnings

(2,881)

(765)

(1,656)

Total equity

8,461

(765)

(1,656)

Liabilities

Non-current liabilities

Lease Liabilities

1,408

Borrowings

1,748

1,215

Total non-current liabilities

3,156

1,215

Current liabilities

Trade and other payables

4,755

179

498

Lease Liabilities

534

Deferred taxation

201

Borrowings

207

1,360

Total current liabilities

5,697

179

1,858

Total liabilities

8,853

1,394

1,858

Total equity and liabilities

17,314

629

202

Consolidated Statement of Cash Flows

For the 6 months ended 30 June 2019

Unaudited

Unaudited

Audited

6 months ended

6 months ended

17 July 2017

 to

30 June

30 June

31 December

2019

2018

2018

€’000

€’000

€’000

Cash Flow from operations

Loss before income tax – continuing operations

(1,225)

(463)

(1,656)

Adjustments:

– Depreciation & Amortisation

– Net finance costs

250

12

45

Changes in working capital

– Trade and other receivables

(22)

(17)

(36)

– Trade and other payables

552

24

497

Cash used in operations

(445)

(444)

(1,150)

Interest paid

(38)

(12)

(45)

Income tax received/(paid)

Net cash (used) in operating activities

(483)

(456)

(1,195)

Cash flow from investing activities

Investment in subsidiary

42

Purchase of property, plant and equipment (PPE)

Interest received

Net cash used in investing activities

42

Cash flow from financing activities

Proceeds from public placing on 28 June 2019

5,025

Issuance of ordinary shares

1,543

Convertible Debentures Issued or converted

(1,010)

1,360

Conversion premium on Convertible Debentures

(212)

Short Term Loan Repaid

(200)

(200)

Short Term Loan received

915

200

Net cash flow from financing activities

5,346

715

1,360

Net increase in cash and cash equivalents

4,905

259

165

Cash and cash equivalents at beginning of period

165

324

Cash and cash equivalents at end of period

5,070

583

165

 

Consolidated Statement of Changes in Shareholders’ Equity

 

 

 

 

Share

capital

 

Share

premium

Re-organisation & reverse acquisition and other

reserves

Foreign Currency reserve

 

Retained

earnings

 

 

Total

€’000

€’000

€’000

€’000

€’000

€’000

At 18 July 2017

Changes in equity for period

ended 31 December 2017

Total loss for the period

(301)

(301)

Total comprehensive loss for

the period

(301)

(301)

Transactions with the owners

Shares /Options issued

At 1 January 2018

(301)

(301)

Changes in equity for 6 months

ended 30 June 2018

Total loss for the period

(463)

(463)

Total comprehensive loss for

the period

(463)

(463)

Transactions with the owners

Shares /Options issued

At 30 June 2018

(764)

(764)

Changes in equity for 6 months

ended 31 December 2018

Total loss for the period

(892)

(892)

Total comprehensive loss for

the period

(892)

(892)

Transactions with the owners

Shares issued

At 31 December 2018

(1,656)

(1,656)

Changes in equity for 6 months

ended 30 June 2019

Total loss for the period

(1,225)

(1,225)

Total comprehensive loss for

the period

(1,225)

(1,225)

Transactions with the owners

Shares issued to Public

90

4,247

4,337

Investment In subsidiary

281

14,726

(7,958)

(44)

7,005

At 30 June 2019

371

18,973

(7,958)

(44)

(2,881)

8,461

 

NOTES FORMING PART OF THE INTERIM FINANCIAL STATEMENTS

1.              General information and basis of presentation

 

Open Orphan Plc (formerly Venn Life Sciences Holdings Plc) is a company incorporated in England and Wales. The Company is a public limited company, listed on the AIM market of the London Stock Exchange. The address of the registered office is 2nd floor, Berkeley Square House, Mayfair, W1J 6BD.

The Group’s principal activity is as a European-focused, rare and orphan drug consulting services platform.

Open Orphan Plc (formerly Venn Life Sciences Holdings Plc) completed an IPO on the London AIM Exchange and the Dublin Euronext exchange on 28 June 2019 through a reverse merger of Open Orphan DAC, an Irish Company, into Venn Life Sciences holdings Plc, a UK company.

Based on the accounting standards under IFRS 3 and IFRS 10, the Group has determined that the entity with control of the combined group after the combination is Open Orphan DAC. It was therefore determined that reverse acquisition accounting is to be applied for presentation of the financial statements of the Company. This means that results reported for the period and comparable periods reflect those of Open Orphan DAC while the Balance Sheet reported for the period and comparable periods reflect those of the combined group with share capital reflecting the position of the ultimate parent Company Open Orphan Plc.

For information purposes, a pro forma statement of Comprehensive Income for the period and comparable periods for Open Orphan Plc on a stand-alone basis and excluding any impact of the combination is presented in note 3 to allow a normalized presentation of Comprehensive Income for the existing Group during the period.

The accounting policies applied by the Group in this financial information are the same as those applied by the Group in its financial statements for the year ended 31 December 2018 and which will form the basis of the 2019 financial statements except for a number of new and amended standards which have become effective since the beginning of the previous financial year. In particular, IFRS 16 has been adopted as at 1 January 2019 in accordance with the modified retrospective approach. Right-of-Use assets and lease liabilities have been reflected in the Consolidated Statement of Financial Position.

The financial information presented herein does not constitute full statutory accounts under Section 434 of the Companies Act 2006 and was not subject to a formal review by the auditors. The financial information in respect of the year ended 31 December 2018 has been extracted from the statutory accounts which have been delivered to the Registrar of Companies. The Group’s Independent Auditor’s report on those accounts was unqualified, did not include references to any matters to which the auditor drew attention by way of emphasis without qualifying their report and did not contain a statement under section 498(2) or 498(3) of the Companies Act 2006. The financial information for the half years ended 30 June 2019 and 30 June 2018 is unaudited and the twelve months to 31 December 2018 is audited.

2.                            Earnings per share

 

(a)  Basic                                    

Basic earnings per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of ordinary shares in issue during the period.

 

Unaudited

Unaudited

Audited

6 months ended

6 months

ended

17 July 2017 to

30 June

30 June

31 December

2019

€’000

2018

€’000

2018

€’000

 

Loss from continuing operations attributable to equity holders of the Company (€’000)

(1,225)

(463)

(1,656)

Total

(1,225)

(463)

(1,656)

Weighted-average Ordinary Shares in issue

74,413,349

210,902

210,902

Basic and diluted loss per ordinary share (€ cent)

(1.65)

(219.73)

(785.29)

            

(b)  Diluted

 

Due to the losses in the periods the effect of the share options and warrants noted below were considered to be anti-dilutive.

Unaudited

Unaudited

Audited

6 months

ended

6 months ended

17 July 2017 to

30 June

2019

30 June

2018

31 December

2018

Potential dilutive ordinary shares:

Weighted Options

5,324,569

Weighted Warrants

6,234,278

Total

11,558,847

3.         Proforma Statement of Comprehensive Income – Open Orphan Plc (on a stand-alone basis and excluding any impact of the 28 June 2019 combination)

Per note 1, the schedule below reflected normalised Comprehensive Income for Open Orphan Plc (formerly Venn Life Sciences Holdings Plc) as if it were presented on a stand-alone basis and excluded any impact of the 28 June 2019 combination.

Unaudited

Unaudited

Audited

6 months ended

6 months ended

Year ended

30 June

30 June

31 December

2019

2018

2018

€’000

€’000

€’000

Continuing operations

Revenue

5,814

7,780

14,291

Administrative expenses

(8,020)

(8,045)

(16,658)

Operating (loss)

(2,206)

(265)

(2,367)

  Depreciation and amortisation

(702)

(473)

(935)

EBITDA before exceptional items

(1,504)

208

(1,432)

Finance income

10

Finance costs

(167)

Gain/Impairment of Financial Asset Investments

444

(360)

(421)

Share Options and Warrants Reserve

(238)

Impairment of Intangible Assets

(2,232)

Loss before income tax

(2,167)

(625)

(5,010)

Income tax credit

378

33

235

Loss for the period

(1,789)

(592)

(4,775)

Loss attributable

Owners of the parent

(1,789)

(592)

(4,775)

Loss for the period

(1,789)

(592)

(4,775)

Currency translation differences

(3)

(46)

85

Total comprehensive loss for the period

(1,792)

(638)

(4,690)

4.            Dividends

There were no dividends provided or paid during the six months.

5.            Press

A copy of this announcement is available from the Company’s website, being www.openorphan.com.  If you would like to receive a hard copy of the interim report, please contact the Open Orphan Plc offices on +353 1 644 0007 to request a copy.

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