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REG - hVIVO PLC - Interim results

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RNS Number : 0789M  hVIVO PLC  12 September 2023

hVIVO plc

("hVIVO" or the "Group")

 

Interim results

Strong first half performance and record forward visibility

 Upgrade of Full Year Revenue and EBITDA Guidance

 

hVIVO plc (AIM & Euronext: HVO), the world leader in testing infectious
and respiratory disease products using human challenge clinical trials,
announces its unaudited interim results for the six-month period ended 30 June
2023.

 

Financial highlights

 

·    First half revenue growth of 52% to £27.3 million* (H1 2022: £18.0
million)

·    EBITDA more than doubled to £5.2 million (H1 2022: £2.3 million)

·    EBITDA margin increased to 19.1% (H1 2022: 12.6%)

·    Net cash of £31.3 million as at 30 June 2023 (H1 2022: £15.9
million)

·    Weighted contracted orderbook of £78 million as at 30 June 2023 (30
June 2022: c.£70 million)

 

*The Group will now report revenue excluding other income, such as R&D tax
credits. Other income in H1 2023 was £1.4 million (H1 2022: £0.9 million).

 

Operational highlights

 

·    Human metapneumovirus (hMPV) challenge model under development,
funded by an end-to-end human challenge service contract with North American
biopharmaceutical company

·    Completed the manufacturing of Influenza H1N1 and Omicron human
challenge viruses

·    Asia-Pacific (APAC) region identified as a key long term growth area,
underscored by the signing of first challenge trial contract signed with APAC
client in over a decade

·    The Group's fast growing drug development consultancy arm, Venn Life
Sciences, awarded a €3.2 million contract with a major pharmaceutical client

·    Value proposition for human challenge trials reinforced by positive
outcomes from hVIVO challenge trials

o  Pfizer's ABRYSVO™ became one of the first RSV vaccines to receive FDA
approval in May 2023 having received Breakthrough designation

o  Cidara received FDA Fast Track designation for its influenza antiviral
candidate in June 2023

o  SAB Biotherapeutics received FDA Breakthrough and Fast Track designation
for its influenza antiviral candidate in April 2023

 

Post-period end highlights

 

·    New state-of-the-art facility, largely funded by a number of hVIVO
clients and which only involves a nominal cash contribution by the Group, is
due to open in H1 2024. This facility will have 50 quarantine bedrooms, with
potential to expand to 70 beds, enlarged cutting-edge laboratories, an
outpatient unit, and corporate office

·    Flu B challenge model under development, funded by £13.1 million
bespoke manufacturing and characterisation contract with existing top five
global pharmaceutical client

 

Current trading and outlook

 

As at 30 June 2023, the Group's weighted contracted orderbook increased to
£78 million (H1 2022: £70 million), an increase of 11%. The orderbook is
diversified across multiple clients, challenge agents and geographies,
allowing the management team to effectively optimise its resources and enhance
its adaptability and flexibility in managing its revenue pipeline. Coupled
with its track record of excellent operational delivery, this provides a
strong foundation for future growth.

 

The Group recently announced its plan to move to a new state-of-the-art
facility which is due to open in H1 2024. The move will enable the Group to
increase its revenue potential by increasing its number of quarantine beds,
improving its ability to conduct larger studies faster, enable multiple
concurrent trials improving utilisation levels and support the development of
new CRO service revenue streams. Additionally, consolidating hVIVO's clinical
and laboratory operations into a single location will lead to improved
operational efficiencies, further enhancing long term margins. Its current
quarantine facilities will remain open until the new facility is fully
operational, however by availing of break clauses in its current leases, the
Group has ensured an orderly transition to its new and improved facility and
as such, will not incur lease costs on any of its legacy quarantine facilities
beyond Q3 2024.

 

The Group has minimised the impact from delays in UK clinical trial approvals
by the Medicines and Healthcare products Regulatory Authority (MHRA) by
working closely with its clients and the MHRA in recent months and has
received all outstanding approvals. hVIVO continues to monitor the situation
closely, working with its clients to ensure the timely delivery of its
studies.

 

hVIVO increases its revenue guidance to £55 million (excluding other income)
for 2023 and increases its EBITDA margin guidance for 2023 to c.19%.

 

Dividend

 

The Company intends to pay a nominal annual dividend going forward, details of
which will be announced alongside publication of the Group's audited results
for FY23.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "The first half of
2023 has delivered another period of excellent growth and progress towards our
goal of establishing a long-term sustainable growth model. The increasing
number of trials, as well as the growing volunteer cohorts and expanding use
cases, highlights that the human challenge market is experiencing a strong
growth trend that we strongly believe will continue over the long term. The
outlook for the business is extremely positive, as our new state-of-the-art
facility sets us up to accelerate our growth over the long term. We are
delighted to increase our revenue guidance and EBITDA margin guidance for
2023. Finally, I would like to thank our staff for their continued dedication
and boundless enthusiasm as we progress towards our vision to transform global
healthcare."

 

Investor presentation

 

Yamin 'Mo' Khan, Chief Executive Officer, and Stephen Pinkerton, Chief
Financial Officer, will provide a live presentation via the Investor Meet
Company platform on 12 September 2023 at 18:00 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 hVIVO here
(https://www.investormeetcompany.com/open-orphan-plc/register-investor) .

 

 

For further information please contact:

 

 hVIVO plc                                       +44 (0) 20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Liberum Capital (Nominated Adviser and Joint Broker)                       +44 (0) 20 3100 2000
 Ben Cryer, Edward Mansfield, Phil Walker, Will King

 Cavendish Capital Markets Ltd (Joint Broker)                              +44 (0) 20 7220 0500
 Geoff Nash, Charlie Beeson (Corporate Finance)

 Nigel Birks, Harriet Ward (ECM)

 Davy (Euronext Growth Adviser and Joint Broker)                           +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0) 20 7933 8780 or hvivo@walbrookpr.com

 Stephanie Cuthbert / Phillip Marriage /         +44 (0) 7796 794 663 / +44 (0) 7867 984 082 /

Louis Ashe-Jepson
+44 (0) 7747 515 393

 

Notes to Editors

 

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing
specialist contract research organisation (CRO) and the world leader in
testing infectious and respiratory disease vaccines and therapeutics using
human challenge clinical trials. The Group provides end-to-end early clinical
development services to its large, established and growing repeat client base,
which includes four of the top 10 largest global biopharma companies.

 

The Group's fast-growing services business includes a unique portfolio of 11
human challenge models, with a number of new models under development, to test
a broad range of infectious and respiratory disease products. The Group has
world class challenge agent manufacturing capabilities, specialist drug
development and clinical consultancy services via its Venn Life Sciences
brand, and a lab offering via its hLAB brand, which includes virology,
immunology biomarker and molecular testing. The Group offers additional
clinical field trial services such as patient recruitment and clinical trial
site services.

 

hVIVO runs challenge studies in London from its Whitechapel quarantine clinic,
its state-of-the-art QMB clinic with its highly specialised on-site virology
and immunology laboratory, and its clinic in Plumbers Row. To recruit
volunteers / patients for its studies, the Group leverages its unique clinical
trial recruitment capability via its FluCamp (http://www.flucamp.com)
volunteer screening facilities in London and Manchester.

 

CEO Statement

For the six months ended 30 June 2023

 

Establishing a long-term sustainable growth model

 

The first half of 2023 has seen further excellent progress towards our goal of
establishing a long-term sustainable growth model. I strongly believe that
human challenge trials (HCTs) remain an underutilised means of developing
vaccines and antivirals, and over the past 18 months we have seen a
significant increase in both the number and size of trials as a greater number
of big pharma and biotech companies realise the time and cost savings of HCTs
over traditional field trials. The rise in demand for HCTs was reflected in
the substantial growth in first half revenues, driven by the delivery of a
higher number of challenge trials and the continued growth in our orderbook,
which is diversified across clients, challenge agents and geographies. The
robust orderbook underpins the sustainable growth trajectory of the Group
providing revenue visibility into late 2024. This has enabled management to
effectively plan and strategise into the long term.

 

We continued to deliver improved profit margins in the period which translated
to robust cash generation. The efficiency initiatives implemented to maximise
quarantine bed occupancy and improve volunteer conversion rates are now
beginning to deliver sustainable improvements in performance. This is the
result of conducting multiple challenge model trials concurrently, with
volunteers delivered by our revamped FluCamp volunteer recruitment platform.

 

I believe there are still greater opportunities to drive efficiencies across
the Group, and our recently announced move to a larger state-of-the-art
facility is a clear indicator that we are committed to further improvement in
this regard over the long term. I am very proud of what the team has achieved
in H1 2023 and I am inspired by their continued drive and commitment to
achieve our shared mission of delivering today's healthcare by empowering
tomorrow's innovation.

 

Optimised business model delivers record financial performance

 

hVIVO delivered record revenue of £27.3 million in H1 2023 (H1 2022: £18.0
million), a 52% increase on H1 2022. The Group recorded exceptional EBITDA
growth of 129% to £5.2 million (H1 2022: £2.3 million), with EBITDA margin
increasing to 19.1% (H1 2022: 12.6%). This is the result of our continued
focus on optimising hVIVO's business model, driving operational improvements
and efficiencies combined with disciplined capital allocation to deliver
improved profitability.

 

The focus on operational excellence has enhanced cash generation with net cash
of £31.3 million as at 30 June 2023 (H1 2022: £15.9 million). The Group is
debt free, has a robust net working capital, and has structured its contracts
to be cash flow positive for hVIVO. All of our challenge trial contracts
include a non-refundable quarantine booking fee, with milestone payments that
are set to forward fund the next phase of the challenge trial.

 

Seeing the benefits of human challenge trials ("HCTs")

 

The significant uptake in the use of HCTs over the past 18 months has been
fuelled by increasing real-world examples of their benefits over traditional
field trials. These include expedited development and regulatory review
timelines, and early proof of concept data with the potential to increase the
valuation of biotech companies and their assets. A few recent examples that
have underlined the value proposition of HCTs include:

 

·    Pfizer's ABRYSVO™, one of the first RSV vaccines to receive FDA
approval in May 2023 having received Breakthrough designation

·    Cidara received FDA Fast Track designation for its influenza
antiviral candidate in June 2023

·    SAB Biotherapeutics received FDA Breakthrough and Fast Track
designation for its influenza antiviral candidate in April 2023

 

The growth in demand for HCTs is reflected in the increasing scope of the
contracts we have signed. Our clients want to collect more information than
just whether the drug is effective or not; this additional information may
include determining the optimal dose, exploring various primary and secondary
endpoints, defining timepoints for late-stage trials and/or comparing products
developed through different technologies. A case in point is the head-to-head
comparison of a vaccine manufactured using different technologies in a single
trial, the goal being the identification of the best candidate to progress to
late-stage clinical development. Consequently, a larger number of volunteers
are required to obtain statistically significant data.

 

New state-of-the-art facility

 

The goal to establish a long-term sustainable growth model has been reinforced
by plans to move to a bigger state-of-the-art facility. Our goal has always
been to increase our capacity in the future, but we have shown great agility
to take full advantage of an opportune moment to expedite our expansion. The
availability of the right facility at the right price, the high orderbook, the
demand for standalone laboratory work, the timing of the break clauses in
current quarantine facility leases, and the economic support from our
customers all make it an ideal time for this move. This move has been largely
funded by a number of hVIVO clients (with a nominal cash contribution by the
Group), underscoring the crucial role that HCTs are increasingly playing in
the development of new vaccines and antivirals. The move is a central piece of
our long-term plan and will increase our number of quarantine beds to 50 with
the potential to expand to 70 beds. It will also allow us to significantly
enhance our lab offering and capacity with cutting-edge virology and
immunology laboratories.

 

Ultimately, consolidating our operations into a single location will result in
further operational efficiencies, further enhancing long term margins. The
move is expected to be a seamless transition, completed over two phases to
ensure uninterrupted service delivery for our clients as well as ensuring that
the Group will not incur lease costs on any legacy quarantine facilities
beyond Q3 2024. The Group's volunteer screening facilities and outpatient unit
in Manchester and in East London will remain in place.

 

World leading diversified offering

 

A key cornerstone of our growth strategy has been to leverage the sustained
growth in demand for challenge studies to diversify our service offering
beyond challenge studies by establishing new revenue streams and increasing
utilisation across our existing resources to further increase profit margins.

 

A main driver of this has been to develop new challenge models, paid for by
our clients, in indications where they have expressed concrete interest in
completing a challenge study. We have expanded our library of challenge
models, having completed the manufacturing of our Omicron and H1N1 influenza
challenge agents in H1 2023. We have also signed a new end-to-end human
challenge service contract to develop a human metapneumovirus (hMPV) as well
as a bespoke influenza B challenge model contract. Challenge agent manufacture
has developed into a strong revenue source with healthy year-on-year growth.
This is a service unique to hVIVO who are the only global provider with the
capabilities to manufacture and characterise a new virus and subsequently
conduct a full challenge trial, positioning us as the clear leader in this
growing market.

 

Venn Life Sciences, our drug development consulting subsidiary, reported
strong revenue growth of 20% in the first half of 2023. We believe there are
further growth opportunities at Venn and have identified ATMP (advanced
therapy medicinal products) and drug device consulting as key areas for
investment. We are also seeing an increase in consultancy services at hVIVO in
clinical development, regulatory affairs, and quality assurance.

 

In addition, we signed our first contract with a large global CRO in 2023 for
volunteer repurposing. This involves redirecting FluCamp volunteers that did
not meet the eligibility criteria for challenge studies to our global CRO
partner for inclusion in one of their studies. Finally, we are particularly
excited about the opportunity for our lab services. The new lab facilities at
Canary Wharf will significantly increase our sample throughput and enhance
hLAB, the Group's highly specialised virology and immunology laboratory
service offering, to deliver industry leading lab services to HCT and other
biopharma clients.

 

Increasing global demand for human challenge trials

 

The Group's weighted orderbook of signed contracts continued its long-term
growth trend by increasing to £78 million as at 30 June 2023 (H1 2022: £70
million). hVIVO continued to add to its contracted orderbook in the first half
of 2023, signing a bespoke human challenge model contract as well as an
end-to-end human challenge service contract (influenza B and hMPV) in addition
to signing its first human challenge trial contract with a client in the APAC
region in over a decade. This represents an important milestone, underlining
the global demand for HCTs. North America and Europe continue to be the main
sources of revenue for the Group, but we have identified APAC as a key growth
region and anticipate further demand from APAC-based companies going forward.

 

hVIVO's potential pipeline of HCTs is continuing to increase, with the number
of phase I and II clinical trials in disease indications for which hVIVO has
developed a challenge model growing annually. This is also reflected in the
long-term upward trend in the number of vaccine studies conducted each year.
As the funding environment for biotechnology companies remains challenging, we
are seeing an increasing interest in challenge trials from prospective biotech
clients as they look to minimise risk, reduce costs and development timelines,
and obtain crucial human efficacy data.

 

Positive outlook

 

The first half of 2023 has delivered another period of excellent growth and
demonstrates further progress towards our goal of establishing a long-term
sustainable growth model. The increasing number of HCTs, as well as the
growing volunteer cohorts and expanding use cases, highlights that the market
is experiencing a strong growth trend that we firmly believe will continue
over the long term. The Group is well capitalised and in a robust financial
position to develop new revenue streams and increase profitability through
both organic and inorganic opportunities. This, combined with the new models
under development and the Group's track record of excellent operational
delivery gives the Board confidence that hVIVO will maintain its strong upward
growth trend.

 

The Group has minimised the impact from delays in UK clinical trial approvals
by the Medicines and Healthcare products Regulatory Authority (MHRA) by
working closely with its clients and the MHRA in recent months and has
received all outstanding approvals. hVIVO continues to monitor the situation
closely, working with its clients to ensure the timely delivery of our
studies.

 

The outlook for the business remains extremely positive, with revenue for 2023
fully contracted and our orderbook providing excellent visibility over revenue
into late 2024, as well as a new state-of-the-art facility equipped to
accelerate our growth over the long term. The Board has increased its revenue
guidance to £55 million for 2023 as well as increasing its EBITDA margin
guidance to c.19% for 2023. Furthermore, it is the Board's intention to pay a
nominal annual dividend following the publication of the full year results for
2023.

 

Finally, I would like to thank our staff for their continued dedication and
boundless enthusiasm as we progress towards our vision to transform global
healthcare.

 

Yamin 'Mo' Khan

CEO

11 September 2023

 

 

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2023

 

                                                                            6 months ended             6 months ended  Year ended
                                                                            30 June 2023               30 June 2022    31 December 2022
                                                                            Unaudited                  Unaudited       Audited
                                                 Note                       £'000                      £'000           £'000
 Operations
 Revenue, from contracts with customers                                     27,297                     18,010          48,477
 Other operating income                                                     1,352                      861             2,220
 Direct project and administrative costs                                    (23,439)                   (16,599)        (41,625)
 EBITDA before exceptional items                                            5,210                      2,272           9,072
 Depreciation & amortisation                                                (1,340)                    (1,436)         (2,930)
 Exceptional items                                                          (219)                      (186)           (119)
 Operating profit                                                           3,651                      650             6,023
 Net finance income/(expense)                                               530                        (172)           617
 Impairment of investment in associate                                      -                          -               (6,957)
 Share of loss of associate using equity method                             -                          (25)            (48)
 Profit/(loss) before income tax                                            4,181                      453             (365)
 Income tax charge                                                          (253)                      (176)           (411)
 Profit/(loss) for the year                                                 3,928                      277             (776)
 Profit/(loss) for the year is attributable to:
 Shareholders                                                               3,928                      277             (776)
 Other comprehensive income
 Currency translation differences                                            (106)                      (173)           27
 Total comprehensive income/(loss) for the year                             3,822                      104             (749)

 Earnings per share attributable to shareholders during the year:
 Basic earnings per share                        3                          0.58p                      0.04p           (0.12p)
 Diluted earnings per share                      3                          0.58p                      0.04p           (0.12p)

 Adjusted earnings per share attributable to shareholders during the year:
 Basic adjusted earnings per share               3                          0.58p                      0.04p           0.90p
 Diluted adjusted earnings per share             3                          0.58p                      0.04p           0.90p

 

 

 

 

 

 

 

Consolidated Statement of Financial Position

As at 30 June 2023

                                        30 June 2023  30 June 2022  31 December 2022
                                        Unaudited     Unaudited     Audited
                                  Note  £'000         £'000         £'000
 Assets
 Non‐current assets
 Intangible assets                      5,967         6,200         6,023
 Property, plant and equipment          1,482         1,496         1,513
 Investment in associates               -             6,980         -
 Right of use asset                     2,393         2,178         1,610
 Total non‐current assets               9,842         16,854        9,146
 Current assets
 Inventories                            443           687           499
 Trade and other receivables      4     9,947         13,371        13,291
 Cash and cash equivalents              31,346        15,932        28,444
 Total current assets                   41,736        29,990        42,234
 Total assets                           51,578        46,844        51,380
 Equity attributable to owners
 Share capital                          679           671           671
 Share premium account                  428           1             4
 Merger reserves                        (6,856)       (6,856)       (6,856)
 Foreign currency reserves              1,252         1,158         1,358
 Share based payment reserve            590           345           578
 Retained earnings                      25,552        25,483        24,463
 Total equity                           21,645        20,802        20,218
 Liabilities
 Non‐current liabilities
 Lease liabilities                      700           752           737
 Leasehold provision                    660           40            660
 Total non‐current liabilities          1,360         792           1,397
 Current liabilities
 Trade and other payables         5     27,075        23,729        28,869
 Lease liabilities                      1,428         1,425         826
 Leasehold provision                    70            10            70
 Borrowings                             -             86            -
 Total current liabilities              28,573        25,250        29,765
 Total liabilities                      29,933        26,042        31,162
 Total equity and liabilities           51,578        46,844        51,380

 

 

 

 

Consolidated Statement of Changes in Shareholders' Equity

                                                        Share capital  Share premium  Merger reserve  Foreign currency reserve  Share option reserve  Retained earnings  Total
                                                        £'000          £'000          £'000           £'000                     £'000                 £'000              £'000
 At 1 January 2022                                      671            1              (6,856)         1,331                     327                   25,206             20,680
 Changes in equity for the 6 months ended 30 June 2022
 Profit for the period                                  -              -              -               -                         -                     277                277
 Currency differences                                   -              -              -               (173)                     -                     -                  (173)
 Total comprehensive income for the period              -              -              -               (173)                     -                     277                104
 Transactions with the owners
 Share based payment res.                               -              -              -               -                         18                    -                  18
 Total contributions by and distributions to owners     -              -              -               -                         18                    -                  18
 At 30 June 2022                                        671            1              (6,856)         1,158                     345                   25,483             20,802
 Changes in equity for the 6 months ended 30 June 2022
 (Loss) for the period                                  -              -              -               -                         -                     (1,053)            (1,053)
 Currency differences                                   -              -              -               200                       -                     -                  200
 Total comprehensive (loss) for the period              -              -              -               200                       -                     (1,053)            (853)
 Transactions with the owners
 Share based payment res.                               -              -              -               -                         233                   33                 266
 Shares issued                                          -              3              -               -                         -                     -                  3
 Total contributions by and distributions to owners     -              3              -               -                         233                   33                 269
 At 31 December 2022                                    671            4              (6,856)         1,358                     578                   24,463             20,218
 Changes in equity for the 6 months ended 30 Jun 2023
 Profit for the period                                  -              -              -               -                         -                     3,928              3,928
 Currency differences                                   -              -              -               (106)                     -                     -                  (106)
 Total comprehensive income for the period              -              -              -               (106)                     -                     3,928              3,822
 Transactions with the owners
 Share based payment res.                               -              -              -               -                         12                    215                227
 Shares issued                                          8              424            -               -                         -                     -                  432
 Dividends paid                                         -              -              -               -                         -                     (3,054)            (3,054)
 Total contributions by and distributions to owners     8              424            -               -                         12                    (2,839)            (2,395)
 At 30 June 2023                                        679            428            (6,856)         1,252                     590                   25,552             21,645

 

 

 

 

Consolidated Statement of Cash Flows

For the 6 months ended 30 June 2023

                                                                                    6 months ended  6 months ended  Year ended
                                                                                    30 June 2023    30 June 2022    31 December 2022
                                                                                    Unaudited       Unaudited       Audited
                                                                                    £'000           £'000           £'000
 Cash used in operations
 Profit/(loss) before income tax                                                    4,181           453             (365)
 Adjustments for:
 - Depreciation & amortisation                                                      1,340           1,436           2,930
 - Exceptional items                                                                219             186             119
 - Net gain on disposals of fixed assets & leases                                   -               (19)            -
 - Impairment of associate                                                          -               -               6,957
 - Net gain on disposals of PPE                                                     -               -               (12)
 - Net finance (income)/expense                                                     (530)           172             (617)
 - Share based payment charge                                                       227             18              284
 - R & D Credit Incl. in other income                                               (1,343)         (724)           (1,851)
 - Share of Imutex loss                                                             -               25              48
 Changes in working capital:
 - Decrease/(increase) in trade and other receivables                               3,207           (4,389)         (4,309)
 - Decreased/(increase) in inventories                                              56              (28)            172
 - (Decrease)/increase in trade and other payables                                  (768)           5,333           11,152
 Net cash generated in operations                                                   6,589           2,463           14,508
 Income tax (R & D Credit) received                                                 75              -               1,473
 Net cash generated in operating activities                                         6,664           2,463           15,981

 Cash flow from investing activities
 Purchase of property, plant and equipment                                          (386)           (858)           (1,275)
 Purchase of intangible assets                                                      -               (79)            (87)
 Net cash used in investing activities                                              (386)           (937)           (1,362)

 Cash flow from financing activities
 Lease payments                                                                     (1,152)         (1,163)         (2,178)
 Dividends paid                                                                     (3,054)         -               -
 Proceeds from issue of shares                                                      432             -               3
 Exceptional items (paid)                                                           -               (85)
 Interest & FX gains received /(paid)                                               382             (6)             635
 Repayment of convertible debenture security                                        -               (208)           (294)
 Net cash used in financing activities                                              (3,392)         (1,462)         (1,834)

 Net increase in cash and cash equivalents                                          2,886           64              12,785
 Cash and cash equivalents at beginning of period                                   28,444          15,694          15,694
 FX translation                                                                     16              174             (35)
 Cash and cash equivalents at end of period                                         31,346          15,932          28,444

 

 

NOTES FORMING PART OF THE INTERIM FINANCIAL STATEMENTS

 

 

1.    General information

hVIVO plc is a company incorporated in England and Wales. The Company is a
public limited company, limited by shares, listed on the AIM market of the
London Stock Exchange and on Euronext Growth in Dublin. The address of the
registered office is Queen Mary Bio Enterprises, Innovation Centre, 42 New
Road, London, E1 2AX, UK.

 

The principal activity of the Group is that of a growing specialist CRO
pharmaceutical services company which is the world leader in the testing of
vaccines and antivirals using human challenge clinical trials. The Group has a
presence in the UK, Ireland, France and Netherlands.

 

The financial statements are presented in thousands of GBP ("£'000s"), except
where otherwise indicated. The Group comprises hVIVO plc and its subsidiary
companies.

 

The registered number of the Company is 07514939.

 

2.    Basis of preparation and accounting policies

The consolidated financial statements of hVIVO plc have been prepared in
accordance with UK adopted international accounting standards (IFRSs), IFRIC
interpretations and the Companies Act 2006 applicable to companies reporting
under IFRS.

 

The consolidated financial statements have been prepared under the historical
cost convention.

 

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 2022 and which will form the basis of the 2023
financial statements.

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 2022 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 2023 and 30 June 2022 is
unaudited and the twelve months to 31 December 2022 is audited.

The Interim Financial Statements were approved by the Board of Directors on 11
September 2023.

 

 

3.    Earnings per share

                                                                  6 months ended  6 months ended  Year ended
                                                                  30 June 2023    30 June 2022    31 December 2022
                                                                  Unaudited       Unaudited       Audited

 Basic earnings/(loss) per share (p)                              0.58p           0.04p           (0.12)p
 Basic adjusted earnings/(loss) per share (p)                     0.58p           0.04p           0.92p
 Diluted earnings/(loss) per share (p)                            0.58p           0.04p           (0.12)p
 Diluted adjusted earnings/(loss) per share (p)                   0.58p           0.04p           0.90p

 

 

Basic earnings per share has been calculated by dividing the profit
attributable to shareholders by the weighted average number of shares in issue
during the period.

 

Diluted earnings per share has been calculated after adjusting the weighted
average number of shares used in the basic calculation to assume the
conversion of all potentially dilutive shares. A potentially dilutive share is
a warrant or option where its exercise price is below the average market price
of hVIVO shares during the period and any performance conditions attaching to
the scheme have been met at the balance sheet date.

 

The adjusted profit is used in the calculation of adjusted earnings per share
as reconciled below:

 

                                                      6 months ended  6 months ended  Year ended
                                                      30 June 2023    30 June 2022    31 December 2022
                                                      Unaudited       Unaudited       Audited
                                                      £'000           £'000           £'000

 Profit/(loss) for the period                         3,928           277             (776)
 Impairment of investment in associate                -               -               6,957
 Adjusted profit for the period                       3,928           277             6,181

 

The numbers of shares used in calculating basic and diluted earnings per share
are reconciled below.  Where there is a loss in the period, the share
options are deemed to be antidilutive and therefore not included in the
calculation.

 

                                             6 months ended   6 months ended  Year ended
                                             30 June 2023     30 June 2022    31 December 2022
                                             Unaudited        Unaudited       Audited
 Weighted average number of shares in issue

 Basic                                       675,075,857      670,929,314     670,943,918
 Dilution for share options and warrants     4,409,547        6,967,997       -
 Diluted                                     679,485,403      677,897,311     670,943,918

 

 

 

4.    Trade and other receivables

                                                      30 June 2023  30 June 2022  31 December 2022
                                                      Unaudited     Unaudited     Audited
                                                      £'000         £'000         £'000
 Trade receivables                                    4,354         8,658         8,276
 Prepayments                                          948           916           992
 Accrued income                                       1,495         1,119         1,505
 Other receivables (incl. R&D tax credits)            3,150         2,678         2,518
 Total non‐current assets                             9,947         13,371        13,291

 

 

5.    Trade and other payables

                                    30 June 2023  30 June 2022  31 December 2022
                                    Unaudited     Unaudited     Audited
                                    £'000         £'000         £'000
 Trade payables                     1,318         2,781         2,701
 Social security and other taxes    585           797           738
 Other payables                     215           458           718
 Accrued expenses                   5,554         2,486         3,946
 Deferred income                    19,403        17,207        20,766
 Total non‐current assets           27,075        23,729        28,869

 

 

6.    Share based payments

There was a share-based payment charge in the period of £227,000 (H1 2022:
£18,000).

 

7.    Dividend

A special, one off dividend of 0.45 pence per share was paid to shareholders
on 9 June 2023.  The total amount paid by the Company was £3,054,000.

 

8.    Non-adjusting events after the reporting period

In August 2023, the Group agreed to enter into a lease for a state-of-the-art
facility in Canary Wharf, London.  The facility will serve as a comprehensive
site, housing quarantine bedrooms, advanced laboratories, an outpatient unit,
and corporate offices.

 

On 6 September 2023, the Company issued 1,607,142 shares at price of 5.6 pence
per share as a result of warrants being exercised by a former nomad and
corporate finance adviser.

 

9.    Press

A copy of this announcement is available from the Company's website, being
www.hvivo.com (http://www.hvivo.com/) .  If you would like to receive a hard
copy of the interim report, please contact the hVIVO plc offices at
ir@hvivo.com to request a copy.

 

 

 

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.   END  IR FLFITADILLIV

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