Half Yearly Report

RNS Number : 0299A
hVIVO plc
24 September 2015
 



For immediate release 7.00am: 24 September 2015

 

HVIVO PLC

("hVIVO" or the "Company")

 

HALF-YEAR FINANCIAL REPORT

FOR THE SIX MONTHS ENDED 30 JUNE 2015

 

hVIVO plc (AIM: HVO), the pioneer of human challenge models of disease, is pleased to announce its half-year financial report for the six months ended 30 June 2015.

Financial Highlights

§ Revenue was £2.9 million (H1'14: £15.0 million) due to the effects of Ebola continuing into the first half of 2015 and the Company seeing lower than expected demand in 2015 for early phase human challenge clinical trials in influenza

§ Gross profit was £0.9 million and gross profit margin 29.9% (H1'14: gross profit £4.8 million and gross profit margin 32.1%), indicating the efficiency and utilisation of hVIVO's resources despite the lower client engagement revenues

§ Loss before tax of £12.0 million (H1'14: £5.4 million) as significant investment in discovery research and product validation capabilities continues

§ Loss for the period of £9.8 million (H1'14: £3.4 million)

§ Strong financial position with short-term deposits, cash and cash equivalents at 30 June 2015 of £42.5 million (30 June 2014: £31.6 million), reflecting the Company's management of its resources in line with lower than expected demand for its product validation services in the first half of 2015

Operational Highlights

§ Expanded the Company's global marketing and sales capabilities to broaden customer activities and to capitalise on the reinvigoration of influenza programmes in the second half of 2015 and beyond

§ Diversified the platform's repertoire of human disease models with the release of a qualified and reproducible asthma model of disease exacerbation while gaining unique insights into the biological triggers behind asthma exacerbations

§ Accelerated Company's discovery programme ('pathomics') in flu and RSV

Constructed  the first map of the human host response to influenza

Collected RSV 'disease in motion' samples ahead of timelines

§ Advanced the Company's readiness to enter into its own drug and diagnostic development programmes by establishing commercial and intellectual property (IP) strategies and governance practices to support emerging assets

§ Achieved the milestone of having inoculated our 2,000th volunteer in August '15, having inoculated our 1,000th volunteer in December '12

§ Launched the  Company's new name, hVIVO plc

 

Kym Denny, Chief Executive Officer, commented;

 

"The first half of 2015 saw tough trading conditions continue for hVIVO due to the diversion of industry resources to fight Ebola in late 2014 and the stalling of flu drug development programmes. In response, hVIVO exploited the diversity inherent in our 'disease in motion' capability and advanced our plans to leverage the hVIVO platform as an effective drug and diagnostic discovery tool. In less than a year, this decision resulted in the production of the first known map of the human host response to influenza, revealing unique insights into our bodies' reaction to flu infection. We are now in a strong position to qualify relevant biomarkers, heralding in an era of rationally selected drug targets to aim flu treatments and prophylactics.

 

In addition to the advances in our flu R&D programme, we officially released our new asthma model of disease exacerbation for commercial use, diversifying the therapeutic reach of our platform and its pipeline, while also gaining early insights into the mechanics of asthma attacks for our own IP.

 

I am delighted to announce that we achieved in August '15 the significant milestone of having inoculated our 2,000th volunteer, highlighting hVIVO's unsurpassed experience with human disease models.

 

I am heartened by how quickly the Ebola outbreak was contained due to the extraordinary response across the scientific and pharmaceutical communities, and I look forward to leveraging our newly acquired insight into flu as influenza clinical trial programmes regain their momentum within global pharmaceutical and biotech companies."

 

For further information please contact:

hVIVO plc                                                                                          +44 207 756 1300

 

Kym Denny (Chief Executive Officer)

Graham Yeatman (Chief Financial & Business Officer)

 

Media Enquiries                                                      +44 203 021 3933 / +44 7854 979 420

 

Colin Paterson (Director of Marketing, Communication and Public Relations)

 

              

Numis Securities Limited                                                                      +44 207 260 1000

 

Michael Meade / Freddie Barnfield (Nominated Adviser)

James Black / Michael Burke (Corporate Broking)

 

 

Notes to Editors:

hVIVO plc ("hVIVO") is a life sciences company pioneering a technology platform of human disease models to accelerate drug development and discovery in respiratory and infectious diseases. Based in the UK, hVIVO has conducted over 40 clinical studies, involving more than 2,000 volunteers for a range of leading industry, governmental and academic clients.

 

hVIVO plc

Statement from Chief Executive Officer

Introduction

Background

As market leader, hVIVO has conducted over 40 product validation studies with over 2,000 subjects, for a wide range of industry, government, and academia clients and collaborators.

Overview

A First in Flu

Following the acceleration of our flu sample collection protocol in late 2014, hVIVO set its sights on mining the platform for biological insights into the flu disease process while simultaneously developing the analysis methodology for the Company's wider pathomics discovery approach. By Q3 2015, we established our first pathomics map outlining key biological pathways involved in the host response to flu infection. Based on this, we have begun the exciting task of identifying the biological 'tipping point' when flu becomes severe in order to rationally select drug targets and predictive biomarkers. Work in this area is ongoing in 2015 and is progressing to plan.

 

RSV: Preparing to Map

In early 2015 we returned to the clinic with the objective of harvesting proprietary samples in RSV infection. RSV is a prevalent upper respiratory tract disease that afflicts children and the elderly and frequently can cause hospitalisations in children.  There is no effective treatment for the disease today and our RSV human disease model has become the gold standard in early phase RSV drug development. Collection of our own samples allows us to construct a map of the healthy host response to RSV, a critical first step in building a meaningful map of disease pathways in children and the elderly. The study was an enormous success and work is ongoing in 2015 to construct the RSV map development plan and the first set of analysis for biomarker identification.

 

Asthma Model On Line

Another significant milestone was reached in the first half of 2015, with the official release of our human model of viral induced asthma exacerbation. Our initial 'calibration' studies allowed us to develop the model's product specifications (i.e., endpoints, recruitment rates, trial design) and be ready for commercialization. Following confirmation from the independent safety data board that we had successfully and safely induced exacerbations in our asthmatic subjects, we implemented our sales and marketing plans to drive demand and actively pursue client opportunities. We anticipate our first investigational drug product validation study in this model by early 2016.

 

In addition, broadening our platform's therapeutic reach and pipeline potential, our work in asthma revealed previously unrecognised patterns of association that may predict if an asthmatic suffering from a cold will experience an exacerbation of their disease. Such insight offers a compelling opportunity to connect biology and digital data to design powerful disease algorithms, and work is ongoing in 2015 in this area.

 

Becoming 'Product Ready'

Having moved ahead significantly with our R&D efforts in a short span of time, a priority for the first half of 2015 was to put into place a robust commercial infrastructure for safeguarding our growing list of Intellectual Property (IP) and emerging proprietary know how. From this we evolved our strategy to develop two product types: those that the hVIVO platform "enhances" (drug development tools and drugs that are repurposed, repositioned and rescued (DRPx)) and those "derived" from the platform's insights (de novo compounds, digital health solutions and clinical assessment tests).

Platform enhancements, on the whole, are likely to have the quickest route to market, and present an ideal opportunity to realize fully the value that the platform brings to an existing product by decreasing product risk failure, aligning development plans with qualified biology and shortening the time, costs and risks spent in clinical trials.

 

Strengthening and Evolving: Clients and Collaborators

To support the increasing commercial demands of the Company, the first half of 2015 saw us expand our sales force and base it from the US, enabling a more global reach, while also evolving our marketing capabilities to grow and support partnering opportunities. The goal of these investments is to broaden our customer activities and cultivate platform enhancement opportunities with existing and new pharmaceutical and biotechnology clients. Because the hVIVO platform addresses two of the key pain points in our industry - reliable pre-discovery and fast and efficient clinical trials - we are uniquely positioned to add value in a collaborative fashion, conducting targeted, more informed clinical trials for better decision making, re-invigorating existing assets with reprofiling and repositioning, and supporting rational selection of future assets through 'disease in motion' derived targets and biomarkers.

Financial Review

Condensed Consolidated Statement of Comprehensive Income

Loss before taxation was £12.0 million (H1'14 - £5.4 million; 2014 - £22.7 million).

Condensed Consolidated Statements of Financial Position and Cash Flows

Outlook

In the first half of 2015 we launched our new company name, hVIVO plc, to reflect our expanded vision and to recognise the importance of leveraging human biology in motion to resolve pressing unmet medical needs in diseases that are uniquely human. The name change coincided with our first forays into harnessing the platform to obtain biological insights that have alluded us via traditional discovery means, and the platform did not disappoint.  We produced the first known human host response map for flu, launched a new asthma model, and gained unprecedented insight into the biology of asthma exacerbations, heralding in a new era for the Company.

 

Work to build value from these advancements continues in 2015. At the same time, we see demand returning for our clinical services, with a newly emerging asthma model pipeline, pivotal studies in flu and RSV, and a study programme that leverages multiple models against a single drug. At the same time, we are making good strides in the advancement of a more collaborative proposition to offer our clients that enhances the value that together we can achieve from a uniquely positioned drug discovery and development platform. To ensure we maintain momentum in the coming years we continue to diversify our repertoire of disease models, augmenting existing ones to meet the development needs of new product classes and pressing ahead with another respiratory model in COPD for calibration in 2016. As a result, we remain well placed to achieve our 2015 business objectives.

 

I am delighted with the rapid pace of progress and the ensuing opportunities arising out of 2015 as a result of our broad vision and powerful platform. I would like to thank our hVIVO staff for their innovation, dedication and commitment through such an evolving and fast paced year, while also extending my deep gratitude to our investors for their continuing support. I look forward to bringing you further updates on our progress in the months to come.

 

 

 

Kym Denny

Chief Executive Officer

23 September 2015

 

 

hVIVO plc

Condensed Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2015



6 months ended

6 months ended

Year ended



30 June

30 June

31 December



2015

2014

2014



Unaudited

Unaudited

Audited


Note

£'000

£'000

£'000

Revenue


2,888

15,028

18,472

Cost of sales


(2,025)

(10,201)

(12,999)

Gross profit


863

4,827

5,473

Other Income

3

1,002

-

-

Research and development expense (excluding provision against virus inventory)


(7,392)

(3,063)

(10,733)

Research and development expense - provision against virus inventory


(3)

-

(58)

Administrative expense


(6,625)

(7,278)

(17,730)

Loss from operations


(12,155)

(5,514)

(23,048)

Finance income


200

149

358

Finance costs


(9)

(9)

(15)

Loss before taxation


(11,964)

(5,374)

(22,705)

Taxation

3

2,181

1,961

4,269

Loss for the period


(9,783)

(3,413)

(18,436)

Total comprehensive loss for the period attributable to owners of the parent

(9,783)

(3,413)

(18,436)

Loss per share - basic (pence)

4

(14.4p)

(6.3p)

(31.3p)

Loss per share - diluted (pence)

4

(14.4p)

(6.3p)

(31.3p)






All results derive from continuing operations.





The Group has no recognised gains or losses other than the loss for the period.





The accompanying notes are an integral part of the Condensed Consolidated Statement of Comprehensive Income.


 

hVIVO plc

Condensed Consolidated Statement of Financial Position

As at 30 June 2015



30 June

30 June

31 December



2015

2014

2014



Unaudited

Unaudited

Audited


Note

£'000

£'000

£'000

Assets





Non-current assets





Goodwill


1,722

1,402

1,722

Intangible assets


3,075

3,505

3,333

Property, plant and equipment


2,894

3,665

3,153



7,691

8,572

8,208

Current assets





Inventories


3,902

3,570

3,731

Trade and other receivables


3,073

6,576

2,904

Research and development tax credit receivable


2,379

1,818

3,806

Short-term deposits

5

18,020

22,500

28,007

Cash and cash equivalents

5

24,507

9,149

22,826



51,881

43,613

61,274

Total assets


59,572

52,185

69,482

Equity and liabilities





Equity





Share capital


3,447

2,736

3,383

Share premium account


73,591

40,350

72,498

Other reserve


211

922

921

Share-based payment reserve


87

244

249

Merger reserve


4,199

4,199

4,199

Retained deficit


(29,849)

(5,043)

(20,066)

Total equity


51,686

43,408

61,184

Non-current liabilities





Other payables


513

587

550

Provisions


2,521

110

3,130



3,034

697

3,680

Current liabilities





Trade and other payables


4,852

8,080

4,618



4,852

8,080

4,618

Total liabilities


7,886

8,777

8,298

Total liabilities and equity


59,572

52,185

69,482

 

 

The accompanying notes are an integral part of the Condensed Consolidated Statement of Financial Position.

The Interim Condensed Consolidated Financial Statements of hVIVO plc (registered company number 08008725) were approved by the Board of Directors and authorised for issue on 23 September 2015 and signed on its behalf by:

 

 

Graham E Yeatman

Chief Financial and Business Officer

 

hVIVO plc

Condensed Consolidated Statement of Changes in Equity

As at 30 June 2015









Share-












Share

based











Share

premium

payment

Merger

Other

Retained

Total







capital

account

reserve

reserve

reserve

deficit

equity







£'000

£'000

£'000

£'000

£'000

£'000

£'000






As at 1 January 2014

2,686

37,363

239

4,199

-

(1,630)

42,857



















Proceeds from shares issued:













Acquisition of subsidiary

50

2,987

-

-

921

-

3,958






Issue of new shares

-

15

-

-

-

-

15






Placing net of related expense

647

32,133

-

-

-

-

32,780






Total transactions with owners in their capacity as owners

697

35,135

-

-

921

-

36,753






Loss for the period

-

-

-

-

-

(18,436)

(18,436)






Share-based payment expense

-

-

10

-

-

-

10






As at 31 December 2014

3,383

72,498

249

4,199

921

(20,066)

61,184



















Acquisition of subsidiary - deferred consideration

11

699

-

-

(710)

-

-






Exercise of warrant and share options

52

360

(184)

-

-

-

228






Loss for the period

-

-

-

-

-

(9,783)

(9,783)






Issue of new shares

1

34

-

-

-

-

35






Share-based payment expense

-

-

22

-

-

-

22






As at 30 June 2015

3,447

73,591

87

4,199

211

(29,849)

51,686
































As at 1 January 2014

2,686

37,363

239

4,199

-

(1,630)

42,857



















Issued to acquire subsidiary company

50

2,987

-

-

-

-

3,037






Acquisition of subsidiary company - deferred consideration

-

-

-

-

922

-

922






Loss for the period

-

-

-

-

-

(3,413)

(3,413)






Share-based payment expense

-

-

5

-

-

-

5






As at 30 June 2014

2,736

40,350

244

4,199

922

(5,043)

43,408












The accompanying notes are an integral part of the Condensed Consolidated Statement of Changes in Equity.

 

hVIVO plc

Condensed Consolidated Statement of Cash Flows

For the six months ended 30 June 2015



6 months ended

6 months ended

Year ended



30 June

30 June

31 December



2015

2014

2014



Unaudited

Unaudited

Audited



£'000

£'000

£'000

Cash flow from operating activities





Loss before taxation


(11,964)

(5,374)

(22,705)

Adjustments for:





Depreciation of property, plant and equipment


658

580

1,221

Impairment of property, plant and equipment


-

-

672

Amortisation of intangible assets


273

174

435

Share-based payment expense


22

5

10

Payment of Non-Executive Director fees by issue of shares


35

-

15

Finance costs


9

9

15

Finance income


(200)

(149)

(358)

Loss on foreign exchange


-

27

8

(Decrease)/increase in provisions


(609)

-

3,020

Changes in working capital:





Increase in inventories


(171)

(454)

(615)

(Increase)/decrease in trade and other receivables


(281)

(709)

2,965

Increase/(decrease) in trade and other payables


235

(276)

(3,835)

Cash used in operations


(11,993)

(6,167)

(19,152)

Finance costs


(9)

(9)

(15)

Income tax refund


3,775

2,568

2,568

Net cash used in operating activities


(8,227)

(3,608)

(16,599)

Cash flows from investing activities





Acquisition of intangible assets


(15)

(59)

(148)

Acquisition of property, plant and equipment


(400)

(578)

(1,355)

Decrease/(increase) in balances on short-term deposit


9,987

-

(5,507)

Acquisition of subsidiary


-

-

67

Finance income


146

149

361

Net cash generated from/(used in) investing activities


9,718

(488)

(6,582)

Cash flows from financing activities





Net proceeds from issue of shares


228

-

32,780

Other payables repaid


(38)

(38)

(75)

Net cash generated from/(used in) financing activities


190

(38)

32,705






Net increase/(decrease) in cash and cash equivalents


1,681

(4,134)

9,524

Exchange loss on cash and cash equivalents


-

(27)

(8)

Cash and cash equivalents at the start of financial period


22,826

13,310

13,310

Cash and cash equivalents at the end of financial period


24,507

9,149

22,826

               

 

The accompanying notes are an integral part of the Condensed Consolidated Statement of Cash Flows.

 

hVIVO plc

Notes to the Condensed Consolidated Interim Financial Statements

 

1.             Accounting policies

 

Basis of preparation and approval of the Interim Financial Statements

 

The accounting policies adopted in the preparation of the Interim Financial Statements are consistent with those set out in the Group's Annual Report and Financial Statements 2014, which were prepared in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union and as issued by the International Accounting Standards Board ("IASB"), and are expected to be consistent with the accounting policies that will be applied in the Group's Annual Report and Financial Statements 2015.

 

The Interim Financial Statements for the six months to 30 June 2015 do not include all of the information required for full Annual Financial Statements and should be read in conjunction with the Consolidated Financial Statements for the year ended 31 December 2014. The financial information for the six months ended 30 June 2015 and for the six months ended 30 June 2014 is unaudited.

 

The Interim Financial Statements do not comprise statutory accounts within the meaning of Section 434 of the Companies Act 2006.  Statutory accounts for the year ended 31 December 2014 were approved by the Board on 15 April 2015 and delivered to the Registrar of Companies.  The report of the auditors on those accounts was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under Section 498(2) or Section 498(3) of the Companies Act 2006.

 

The Interim Financial Statements have been prepared on a going concern basis which the Directors believe is appropriate for the following reason:

 

The Directors have prepared cash flow forecasts which show the Group expects to meet its liabilities as they fall due for a period in excess of twelve months from the date of the Interim Financial Statements. Management prepares detailed working capital forecasts which are reviewed by the Board on a regular basis. The forecasts include assumptions regarding the status of client engagements and sales pipeline, future revenues and costs together with various scenarios which reflect growth plans, opportunities, risks and mitigating actions. The forecasts also include assumptions regarding the timing and quantum of investment in the Group's research and development programme. Whilst there are inherent uncertainties regarding the cash flows associated with the development of the hVIVO platform, together with the timing of signature and delivery of client engagements, the Directors are satisfied that there is sufficient discretion and control as to the timing and quantum of cash outflows to ensure that the Group is able to meet its liabilities as they fall due for the foreseeable future. At 30 June 2015, the Group had cash and short-term deposits of £42.5m.

 

The Company is a limited liability company incorporated and domiciled in England & Wales and whose shares are quoted on AIM, a market operated by The London Stock Exchange.  The Group Financial Statements are presented in pounds Sterling (£), which is the Group's presentational currency, and all values are rounded to the nearest thousand (£'000) except where indicated otherwise.

 

The Interim Financial Statements were approved by the Board of Directors on 23 September 2015.

 

2.             Segmental information

 

The Group's Chief Operating Decision Maker, the Chief Executive Officer, is responsible for resource allocation and the assessment of performance. In the performance of this role, the Chief Executive Officer reviews the Group's activities in aggregate. The Group has therefore determined that it has only one reportable segment under IFRS 8 Operating Segments, which is "medical and scientific research services".

 

The Group carries out its main activities from the United Kingdom. The Group conducts sales activity in the US and in Europe which is carried out through hVIVO Inc and hVIVO Services Limited respectively. All revenue is derived from activities undertaken in the UK.

 

3.             Taxation


6 Months ended

30 Jun 2015

Unaudited

£'000

6 Months ended

30 Jun 2014 Unaudited

£'000

Year

ended

31 Dec 2014

Audited

£'000





Tax Benefit:




R&D tax credit

(2,212)

(1,818)

(3,806)

Adjustments in respect of prior periods

31

(143)

(143)

Origination and reversal of temporary timing differences

-

-

(320)


(2,181)

(1,961)

(4,269)

 

                The Group continues to account for its recurring annual SME R&D tax credit as an income tax benefit due to the requirement to surrender tax losses in exchange for recoverable R&D credits.  Additionally, the Group's loss from operations before taxation includes Other Income of £1.0m, of which £0.8m relates to amounts receivable following submission to HM Revenue & Customs of an R&D Expenditure Credit (RDEC) claim for 2014 and £0.2m accrued for the first half of 2015.  The Group classifies such RDEC claims as a government grant. No such claims for RDEC have been submitted in prior periods.

 

                The Group has not recognised deferred tax assets relating to carried forward losses and other temporary differences. These deferred tax assets have not been recognised as the Group's management considers that there is insufficient taxable income, taxable temporary differences and feasible tax planning strategies to utilise all of the cumulative losses and it is probable that the deferred tax assets will not be realised in full.

 

4.             Loss per share (LPS)

 

The calculation of the basic and diluted LPS is based on the following data:

 


6 Months ended

30 Jun 2015

Unaudited

£'000

6 Months ended

30 Jun 2014 Unaudited

£'000

Year

ended

31 Dec 2014

Audited

£'000





Loss:




Loss for the period

(9,783)

(3,413)

(18,436)





Number of shares:




Weighted average number of ordinary shares for the purpose of basic LPS

68,106,047

54,384,217

58,839,405

Effect of dilutive potential ordinary shares:




-     share options

-

-

-

-     warrants

-

-

-

Weighted average number of ordinary shares for the purpose of diluted LPS

68,106,047

54,384,217

58,839,405

 

In the six months ended 30 June 2015 and in the comparative periods presented, the potential ordinary shares were not treated as dilutive as the Group is loss making, therefore the weighted average number of ordinary shares for the purposes of the basic and diluted loss per share were the same.

 

5.             Financial assets and liabilities

 

Carrying value of financial assets:

 


30 June

30 June

31 December


2015

2014

2014


Unaudited

Unaudited

Audited


£'000

£'000

£'000

Cash and cash equivalents

24,507

9,149

22,826

Short-term deposits

18,020

22,500

28,007

Trade receivables

948

3,484

446

Other receivables

663

486

667

Accrued income

233

824

162

Total financial assets

44,371

36,443

52,108

 

Carrying value of financial liabilities:

 


30 June

30 June

31 December


2015

2014

2014


Unaudited

Unaudited

Audited


£'000

£'000

£'000

Trade payables

1,941

2,881

2,754

Accruals

1,223

2,256

903

Repayable lease incentive from related parties

588

663

625

Other payables

80

163

177

Total financial liabilities

3,832

5,963

4,459

 

 

Independent review report to hVIVO plc

 

Directors' responsibilities

Our responsibility

Scope of review

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the condensed set of Financial Statements in the interim financial report for the six months ended 30 June 2015 is not prepared, in all material respects, in accordance with International Accounting Standard 34 as adopted by the European Union and the AIM Rules of the London Stock Exchange.

Deloitte LLP


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The company news service from the London Stock Exchange
 
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