Eurobench.com

voda 18 augustus 2021 08:41

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Half Year Update
Investor meeting at 13:00 BST / 14:00 CEST

Paris, France and Camberley, UK – 18 August 2021 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces a half year update in advance of its investor meeting today.

Unaudited revenue for the first half of 2021 increased over 50% to £94.7 million, compared to £63.3 million for the first half of 2020. Of this total revenue, £54 million came from a mixture of overseas sales and a growing UK private testing market, leading to nonDHSC revenue growing 20% year-on-year.

As announced on 21 May 2021, the DHSC sales of £40.8 million are in dispute.

Business update
Contract award with DHSC under PHE framework
Primerdesign, a wholly owned subsidiary of Novacyt, has been awarded a new contract under the PHE National Microbiology Framework, effective immediately, for the supply of PROmate® COVID-19 tests to the NHS. The PROmate® COVID-19 tests have been developed to run on the Company’s q16 and q32 PCR instrument platforms. The q16 and
q32 near patient PCR instrument platforms using the PROmate® COVID-19 test have been validated and can be used at select NHS hospitals. The contract is valued at up to £4.7m and will last until 31 March 2022. There are no minimum purchase levels as part of this contract.

Separately, there is no further update to the announcement on 22 June 2021 in relation
to the Company’s second supply contract with the DHSC which is in dispute.

Non-governmental organisation long-term agreements
Novacyt has entered into a two-year Long-Term Agreement (LTA) with the World Health Organization (WHO) for the supply of its genesig® COVID-19 tests. In addition, the Company has received confirmation from UNICEF that its existing LTA with the organisation has been extended by 12 months to July 2022. To date, Novacyt has shipped orders to a total of eight countries under the UNICEF LTA since September 2020.

Private sector testing
Overall, UK private market sales, which currently includes COVID-19 testing in film, media, travel and corporate industries, increased significantly in Q2 2021 compared to Q1 2021.
The Company believes it is well placed to continue to support this growth during the second half of the year.
As part of its expansion in private testing, the Company has also signed a supply contract initially for genesig® COVID-19 products with Excalibur Healthcare Services, who have invested in new laboratory services in Cambridge, UK, to support COVID-19 testing of private clients.

A key product expected to support second half growth in private testing will be the Company’s PROmate® COVID-19 2G (2 gene) test. As announced on 23 April 2021, the Company’s CE-IVD PROmate® COVID-19 (1 gene) test identifies the SARS-CoV-2 ORF1ab gene. Due to an emerging need in some countries, the Company launched a second CEIVD PROmate® COVID-19 test to identify both the SARS-CoV-2 ORF1ab gene and nsp16 gene.

Outlook
The Company expects continued strong growth in private testing as markets and travel re-open and, as the Northern Hemisphere heads into winter, the potential for higher infection rates will increase the need for COVID-19 testing. Since the start of 2020, the Company has launched 16 new CE-IVD products, and expects to launch a further 10 by the end of 2022.

The Company therefore reiterates revenue guidance of £100 million for the full year, excluding DHSC revenues, as announced on 22 June 2021.

Investor meeting
As announced on 5 August 2021, certain members of the Executive Management Team will present the Company’s strategy alongside an operational update, followed by a live Q&A at 13:00 BST / 14:00 CEST today. This is being hosted through the digital online platform, Investor Meet Company, with dial-in details also available for attendees once registered.

Investors already registered to the platform and added to meet the Company will automatically be invited. If new to the platform, investors and analysts can sign up to Investor Meet Company for free and add to meet Novacyt via the following link:
www.investormeetcompany.com/novacyt-s...

Graham Mullis, Group CEO of Novacyt, commented:
“Novacyt is continuing to address COVID-19 testing for both current and future demand.
We continue to ensure that innovation is at the centre of our strategy and that our growing
portfolio of COVID-19 tests are available to customers in both private and public health
settings to expand existing, and support new, partnerships. Throughout the pandemic,
NHS testing demand has remained a key priority for the Company and the contract award
under the PHE National Microbiology Framework is a testament to our continued
commitment.

“We believe our long-term strategy also supports the growth of Novacyt post-COVID-19.
In particular, our progress and growth potential in the private sector will not only help us
maximize the COVID-19 testing opportunity but also ensure we are well placed, with both
technologies and partners, for sustainable growth beyond COVID-19. We therefore believe
Novacyt is well positioned to continue to build on its business transformation.”

This announcement contains inside information for the purposes of Article 7 of Regulation
(EU) 596/2014.

Bijlage:

voda 16 september 2021 08:51

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Proposed accounting treatment of ongoing DHSC
dispute in 2021 interim results

Paris, France and Camberley, UK – 16 September 2021 – Novacyt (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces the proposed accounting treatment of the ongoing DHSC dispute on its
unaudited H1 2021 interim results for the six months ended 30 June 2021. The interim
results are expected to be announced on 27 September 2021.

There has been no further update to the announcement made at the time of the Company’s
full year results on 22 June 2021, and subsequent half year update on 18 August 2021, in
relation to the DHSC dispute. The accounting treatment of the DHSC revenue and costs in
H1 2021, detailed below, does not change the Company’s legal position or rights in relation
to the dispute. The Company continues to work with its legal advisers to progress the
dispute and believes it has strong grounds to assert its contractual rights.

The Company reiterates revenue guidance, excluding the disputed DHSC revenue, for the
full year of approximately £100 million and underlying EBITDA margin of approximately
40%, as announced on 22 June 2021. However, the full year Group EBITDA margin could
be materially affected by the outcome of the ongoing dispute with the DHSC and the write
down of inventory as detailed below.

At the time of the Company’s half year update on 18 August 2021, it was noted that £40.8
million of revenue in H1 2021 was in dispute with the DHSC. For the purposes of the
interim results, the Company is required to apply the applicable accounting standards to
the disputed revenues. The Board has therefore taken a conservative approach and
decided that while the dispute with the DHSC remains unresolved the Company will not
recognise the H1 2021 revenue of £40.8 million from the DHSC, in line with IFRS 15
accounting standard on revenue from contracts with customers. The remaining H1 2021
revenue of £54.0 million from non-DHSC sales remains unchanged.

In addition to not recognising the £40.8 million of DHSC sales in its interim results, the
Company has prudently decided to recognise manufacturing costs of £6.9 million relating
to these disputed sales.

The Company is also taking an exceptional one-off cost of £28.9m to write down inventory
that the Company had built in anticipation of further DHSC demand and to terminate
supply commitments with third parties in respect of this supply that are no longer required.
This inventory build was Novacyt’s direct response to support the UK Government’s call
for UK manufacturers to build manufacturing capacity and supply chain flexibility in
response to the COVID-19 pandemic and was based on likely demand indicated by DHSC.
The Company will continue to look for ways to use this inventory.

As announced on 18 August 2021, Novacyt continues to supply PROmate® COVID-19 tests
to the NHS under the terms of a new contract awarded by the DHSC under the Public
Health England National Microbiology Framework.

£'000 H1 2021
Underlying
H1 2021
DHSC
dispute
impact
H1 2021
Total Group

Total Group Revenue 53,950 53,950

Gross Profit 38,044 (35,770) 2,274
GP % 71% 4%

EBITDA
EBITDA %

23,169
43%

(35,770)

(12,601) -23%

Consistent with the announcement on 22 June 2021, the underlying business will generate
gross profit of approximately 71% of sales and EBITDA of approximately 43% of sales for
the half year, excluding the impact of the DHSC dispute. The Company’s cash position as
at 30 June 2021 was £77.2 million.

This announcement contains inside information for the purposes of Article 7 of Regulation

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voda 27 september 2021 08:21

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Novacyt S.A. ("Novacyt", the "Company" or the "Group")
Half year 2021 results

Solid underlying financial performance and well-positioned for continued growth Paris, France and Camberley, UK – 27 September 2021 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces its unaudited results for the half year ended 30 June 2021.

Graham Mullis, Group CEO of Novacyt, commented:
“During 2021, Novacyt has remained at the forefront in its response to the constantly changing global COVID-19 pandemic. We have launched 18 new COVID-19 products since the beginning of 2021 and we expect Novacyt to continue to play a major role in COVID19 testing well into 2022. We also remain focused on strengthening our long-term position and executing against our strategy by building our product and instrument platforms and expanding our commercial infrastructure for growth beyond COVID-19. “As my last results as CEO of Novacyt, I would like to take this opportunity to say it has been a privilege and an honour to lead the Company and to work alongside so many talented people who have worked tirelessly in the face of the unprecedented pandemic. I believe Novacyt is better positioned today than it has ever been, based on the capabilities it has developed over the last few years. I am immensely proud of what we have achieved, and I am confident the Company will continue to grow and cement its place as a leading global diagnostics player.”

Financial highlights
- Group consolidated unaudited revenue of £54.0m (H1 2020: £63.3m) excluding £40.8m of H1 DHSC revenues whilst the contract dispute continues
- Non-DHSC revenue increased by 20% to £54.0m (H1 2020: £44.8m) supported by growing UK private testing market
- The Group has booked exceptional cost of sales of £35.8m in connection with the DHSC contract dispute to write down inventory and terminate supply agreements that the Company had built in anticipation of further DHSC demand and to book the cost of products supplied to the DHSC in 2021 that have not been paid for
- Group gross margin before exceptional items was 71%, delivering a gross profit of £38.0m. After the exceptional DHSC related cost of sales, gross margin drops to 4%, delivering a gross profit of £2.3m
- Group adjusted EBITDA of £23.2m before exceptionals (H1 2020: £43.1m)
- Operating loss of £13.6m compared to a profit of £42.2m in H1 2020, driven by the one-time exceptional cost of sales and stock write-dow
- Loss after tax of £12.7m compared to a profit of £35.1m in H1 2020
- Cash at 30 June 2021 of £77.2m with zero debt

Voor veel meer, zie link

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voda 29 september 2021 09:15

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Novacyt S.A.

("Novacyt" , the "Company" or the “Group” )

Notice of r e s cheduled AGM

Paris, France and Camberley, UK – 29 September 20 2 1 – Novacyt ( EURONEXT
GROWTH: ALNOV; AIM: NCYT ), an international specialist in clinical diagnostics,
announces that it will re schedule i ts A nnual G eneral M eeting (AGM) due to be held today
at 2 pm CEST / 1 pm BST to a later date . As usual, and in accordance with French corporate
law, the AGM comprises both ordinary and extraordinary general meetings.
To function as a procedural meeting, the AGM requires a sufficient number of shareholders
to constitute a quorum to ensure the AGM is validly held in accordance with French
corporate law . This threshold has not been met and, in accordance with Article 19 of
Novacyt articles of association, the AGM will be rescheduled. A new date for the AGM and
voting instructions will be communicated separately.

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voda 30 september 2021 07:20

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Novacyt S.A.

("Novacyt" , the "Company" or the “Group”)

Notice of AGM

Paris, France and Camberley , UK – 29 September 20 2 1 – Novacyt ( EURONEXT
GROWTH: ALNOV; AIM: NCYT ), an international specialist in clinical diagnostics,
announces that following the announcement earlier today the Company’s re scheduled
A nnual G eneral M eeting (AGM) will be held on Monday, 18 October 2021 at 2pm CEST/1pm
BST .

The rescheduled AGM will be an open meeting exclusively held through video conference
and as usual, and in accordance with French corporate law, the AGM comprises both
ordinary and extraordinary general meetings.

Shareholders can register for the AGM and access the online meeting platform by visiting
novacytagm.eventitdept.com.

Voting will re - open from 1 October 2021. Forms of Proxy already completed and submitted
and votes cast by electronic means for the first AGM remain valid for all meetings
subsequently convened with the same agenda (art. R. 225 - 77 of the French commercial
code).

As this AGM is an open meeting there will be a facility to vote on - line at the start of the
meeting for those shareholders who have not already voted. However, we would
encourage all shareholders to submit their votes well in advance of the meeting
date , by choosing one of the following options:

- Shareholders can download a copy of the Proxy voting form from
www.novacyt.com./general - meetings for completion and return to
investor.relations@novacyt.com until midnight on Thursday, 14 October 2021. All
submissions must include an electronic signature and be accompanied by evidence
of shareholding, for example a share certificate or statement of holding.

- Shareholders can vote on - line until 3pm CEST on Sunday , 17 October 2021 using
the Votaccess portal www.actionnaire.cic - marketsolutions.eu/fr/identification if
securities held on Euronext Growth are registered with any of the following banks:

CIC, Natixis, Société Générale, Ca ceis, Crédit Agricole, BP2S, BNP Retail, Bourse
Direct, ODDO, Rothschild Martin Maurel, Procapital, Citibank or Deutsche Bank .
The Second Convening Notice of AGM will be published in the Bulletin des Annonces
Légales Obligatoires (BALO) and posted to nominative shareholders on Friday , 1 October
2021 .

- End -

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voda 30 september 2021 08:20

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Novacyt S.A.

("Novacyt", the "Company" or the “Group”)

R&D update

Including launch of two new tests to differentiate between COVID-19
and common winter viruses, and between COVID-19 variants

Paris, France and Camberley, UK – 30 September 2021 – Novacyt (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces an R&D update.

Highlights
- Launch of a new CE Mark Winterplex™ PCR test to diagnose COVID-19, respiratory
syncytial virus (RSV) and types of influenza
- Launch of a new CE Mark Escapeplex™ PCR test to diagnose four key COVID-19
variants
- Development of CO-Prep™ to further automate and streamline the workflow
process of the Company’s near-patient PROmate® test
- Update on PathFLOW® lateral flow test (LFT) portfolio
genesig® SARS-CoV-2 Winterplex™

As the Northern hemisphere approaches the 2021-2022 flu season, Novacyt has carried
out an analysis of recent influenza genome sequences using its specialist bioinformatics
surveillance expertise to determine how significant the genetic drift was in the virus from
the previous year. Through this analysis, Novacyt detected significant mutations in
published sequences of the influenza B (flu B) virus and developed a new Winterplex™
test to address the new flu B strain for the 2021-2022 winter flu season. The new
Winterplex™ test combines flu B, three-gene COVID-19, flu A and RSV assays in a single
kit to provide clinicians and laboratories with a comprehensive testing solution. The test
is designed for use in central laboratories with open PCR platforms.

SNPsig® SARS-CoV-2 Escapeplex™
Following the successful launch of Escapeplex™ as a research-use-only (RUO) test in April
2021, Novacyt has launched a CE Mark version of the test to meet demand for clinical use.
Escapeplex™ includes gene targets for four key mutations or Variants of Concern (VoC) of
SARS-CoV-2, enabling clinicians and laboratories to detect the most significant virus
variants in a single kit. The test identifies four escape mutations known to be associated
with the most significant VoCs. Escapeplex™ has been designed to be used in central
laboratories with open PCR platforms.

Development of CO-Prep™
In line with the Company’s strategy to build on its capabilities in near-patient testing
through improved workflow solutions, Novacyt has codeveloped CO-Prep™, an instrument
for sample handling automation. CO-Prep™ has been designed to automate the liquid
handling steps of the Company’s near-patient PROmate® test. The efficient CO-Prep™
workflow includes a small footprint for use on benchtops or in containment hoods. As a
result, CO-Prep™ offers laboratories increased capacity, automation of repetitive manual
pipetting, increased accuracy, reduction in intra-sample contamination risk, and time for
technicians to concentrate on other work.

The new CO-Prep™ instrument has received significant interest from customers in advance
of the launch next month. PROmate™ and Co-Prep™ have currently been designed for
testing of COVID-19, but both testing and instrument technologies can be used to target
additional diseases in the future.

PathFLOW® update
Further to the announcement on 29 June 2021, the Company’s confirms there is a delay
in the launch of PathFlow® COVID-19 Rapid Antigen, a self-LFT to detect SARS-CoV-2
antigens, previously expected in Q3 2021. This delay is due to increased demand for selftest approvals causing a backlog of tests currently under review by the Company’s Notified Body. The Notified Body has communicated a delay of up to six months, therefore, the Company is also evaluating other approved options for a COVID-19 self-LFT.

Further to the announcement on 23 April 2021, Novacyt’s PathFlow® SARS-CoV-2 SMART
IgG LFT, expected to launch in Q3 2021, is also delayed. This is due to the Company’s
partner being unable to secure sufficient supplies for Novacyt to launch the test. Novacyt
is, therefore, evaluating additional LFT options to detect and differentiate between SARSCoV-2 IgG antibodies.

Novacyt remains focused on expanding its COVID-19 LFT portfolio, following the launch of
its PathFLOW® SARS-CoV-2 antigen and antibody LFTs for professional use earlier this
year, to complement the Company’s growing polymerase chain reaction (PCR) portfolio.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“The launch of two new CE Mark tests, Winterplex™ and Escapeplex™, to address the
approaching winter flu season in the Northern hemisphere and key mutations of COVID19 in a single kit, respectively, reinforces Novacyt’s ability to address evolving needs in the diagnostics market. Novacyt’s continued focus on innovation is demonstrated by the development of CO-Prep™ to provide further workflow solutions for clinicians and
laboratories testing for COVID-19. This automated instrument technology can also be leveraged for future disease areas to support the Company’s growth beyond COVID-19.
We remain committed to identifying patient needs and overcoming healthcare challenges
today and in the years ahead as we continue to strengthen our position as a leading global
diagnostic company.”

- End -

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voda 20 oktober 2021 06:58

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Novacyt S.A.
("Novacyt" or the "Company")
RESULTS OF ANNUAL GENERAL MEETING

Paris, France and Cam berley , UK – 19 October 2021 – Novacyt (EURONEXT GROWTH: ALNOV;
AIM: NCYT), an international specialist in clinical diagnostics, announces that its Annual General
Meeting (AGM) , comprising ordinary and extraordinary general meeting , was held yesterday
afternoon .

The Company is pleased to report that all resolutions proposed to the shareholders were duly passed .
The results of the AGM voting will be available on the Company's website shortly.
In addition, as previously announced on 29 July 2021, David Allmond became Chief Executive Officer
and a member of the Board of Directors of Novacyt on 18 October 2021.
- End –

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voda 2 november 2021 08:51

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Novacyt S.A.

("Novacyt" or the "Company")

Validation of COVID - 19 tests in the UK under CTDA legislation

Paris, France and Camberley, UK – 2 November 2021 – Novacyt (EURONEXT GROWTH:

ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an update
on the availability of its COVID - 19 tests in the UK following implementation of the UK Health
Security Agency’s Medical Devic s (Coronavirus Test Device Approvals) (Amendment)
Regulations 2021 (“CTDA”).

The mandatory CTDA guidelines require all suppliers of COVID - 19 tests ( polymerase chain
reaction and antigen / lateral flow tests ) to submit data on their tests for a desk top validation
if they wish to continue to sell them in the UK . This legislation does not apply or affect any
sales outside the UK.

On 20 October 20 21, the UK Health Security Agency issued a list of productson the CTDA
register that had so far successfully completed CTDA desktop review and been approved. A
second list , the temporary protocol, was also issued detailing products which can remain on
the market whilst validation is being processed with an extended deadline from 1 November
2021 to 28 February 2022. Only validated products , or products on the temporary protocol,
can be sold in the UK after 31 October 2021. The UK Health Security Agency has committed
to continuing its review of submitted tests and updating the CTDA register accordingly.

Novacyt submitted 11 products for review on time to meet the original CTDA submission
deadline of 1 September 2021. To date, Novacyt’s Primerdesign Ltd PROmate® COVID - 19
test has been namedon the temporary protocol ( this encompasses both the PROmate® 1Gene q16 and q32 products) . The CTDA has not yet communicated the status of any of the remaining nine products .

As a result, from 1 November 2021, the Company will only be sellingthe PROmate® COVID -
19 test in the UK until such time the UK Health Security Agency completes its review of the
additional nine products submitted. If no further products are added to the CTDA register,
the impact on full year revenues for 2021 will be circa £3 million.
- End –

For further information, please refer to www.novacyt.com or contact:
Novacyt SA
David Allmond, Chief Executive Officer
James McCarthy, Chief Financial Officer
+44 (0)1276 600081

SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Matthew Johnson / Charlie Bouverat (Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
+44 (0)20 3470 0470

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voda 2 november 2021 08:51

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quote:
voda schreef op 2 november 2021 08:51:
Novacyt S.A.

("Novacyt" or the "Company")

Validation of COVID - 19 tests in the UK under CTDA legislation

Paris, France and Camberley, UK – 2 November 2021 – Novacyt (EURONEXT GROWTH:

ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an update
on the availability of its COVID - 19 tests in the UK following implementation of the UK Health
Security Agency’s Medical Devic s (Coronavirus Test Device Approvals) (Amendment)
Regulations 2021 (“CTDA”).

The mandatory CTDA guidelines require all suppliers of COVID - 19 tests ( polymerase chain
reaction and antigen / lateral flow tests ) to submit data on their tests for a desk top validation
if they wish to continue to sell them in the UK . This legislation does not apply or affect any
sales outside the UK.

On 20 October 20 21, the UK Health Security Agency issued a list of productson the CTDA
register that had so far successfully completed CTDA desktop review and been approved. A
second list , the temporary protocol, was also issued detailing products which can remain on
the market whilst validation is being processed with an extended deadline from 1 November
2021 to 28 February 2022. Only validated products , or products on the temporary protocol,
can be sold in the UK after 31 October 2021. The UK Health Security Agency has committed
to continuing its review of submitted tests and updating the CTDA register accordingly.

Novacyt submitted 11 products for review on time to meet the original CTDA submission
deadline of 1 September 2021. To date, Novacyt’s Primerdesign Ltd PROmate® COVID - 19
test has been namedon the temporary protocol ( this encompasses both the PROmate® 1Gene q16 and q32 products) . The CTDA has not yet communicated the status of any of the remaining nine products .

As a result, from 1 November 2021, the Company will only be sellingthe PROmate® COVID -
19 test in the UK until such time the UK Health Security Agency completes its review of the
additional nine products submitted. If no further products are added to the CTDA register,
the impact on full year revenues for 2021 will be circa £3 million.
- End –

For further information, please refer to www.novacyt.com or contact:
Novacyt SA
David Allmond, Chief Executive Officer
James McCarthy, Chief Financial Officer
+44 (0)1276 600081

SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Matthew Johnson / Charlie Bouverat (Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
+44 (0)20 3470 0470

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voda 26 november 2021 08:18

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Novacyt S.A.
("Novacyt", the "Company" or the "Group")
Approval of COVID-19 test in the UK under CTDA
legislation

Paris, France and Camberley, UK – 26 November 2021 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that, further to the announcement on 2 November 2021, the Company’s genesig® COVID-19 Real-Time PCR test has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA”). The genesig® COVID-19 test is Novacyt’s first test to be added to the CTDA register and the Company will now work to resume the sale of the product in the UK.

Novacyt’s genesig® COVID-19 assay was launched on 31 January 2020 and was one of the world’s first commercially available tests for COVID-19. To date, the genesig®COVID19 test, which targets the ORF1ab gene, continues to be able to detect all known variants and mutations of COVID 19, with over 4.5 million sequences analysed, as documented in
Novacyt’s latest weekly bioinformatic surveillance report.

As announced on 2 November 2021, the Company submitted 11 products for review under the CTDA to meet the original submission deadline of 1 September 2021. Further to the validation of its genesig® COVID-19 test, Novacyt's Primerdesign Ltd PROmate® COVID19 test (encompassing both the PROmate® 1 Gene q16 and q32 products) remains on the temporary protocol and continues to be supplied to the NHS under the PHE National Microbiology Framework. The Company awaits updates on the additional eight products submitted to the CTDA across its COVID-19 testing portfolio. To note, only validated products, or products on the temporary protocol, can be sold in the UK after 31 October 2021.

On 2 November 2021, Novacyt also stated that if no further products were added to the CTDA register, the impact on full year revenues for 2021 would be circa £3 million. With this approval, the financial impact on 2021 will be significantly lower as the genesig® COVID-19 test accounts for approximately 30% of the circa £3 million revenue shortfall.

David Allmond, Group CEO of Novacyt, commented:
“I am delighted to announce that our genesig® COVID-19 test has become the seventh product to be approved and added to the CTDA register. With the associated resumption of the sale of this product in the UK, we look forward to ensuring our customers continue to have access to this market leading test during the winter season. Our genesig® COVID19 test was launched in late January 2020 and is recognised globally by leading public health bodies, including the US FDA1 , alongside long term agreements with both UNICEF and the World Health Organization. We continue to engage with the UK Health Security Agency and look forward to further updates on our tests still under review.”

End

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voda 15 december 2021 16:49

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Update over Omicron. De pdf is nu beveiligd tegen kopieren!

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voda 25 januari 2022 08:16

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Novacyt S.A.
("Novacyt", the "Company" or the "Group")

Strategy and Full Year 2021 Trading Update

Full year revenue and EBITDA in line with expectations

Committed to becoming a leading, global clinical diagnostics company

Paris, France and Camberley, UK - 25 January 2022 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an unaudited trading update for the year ended 31 December 2021, together with a strategy update following Chief Executive Officer David Allmond's first 100 days with the Company. Reported revenues and EBITDA for the period are both expected to be in line with expectations. The Company intends to announce its 2021 audited full year results in the week commencing 25 April 2022.

David Allmond, Group Chief Executive Officer of Novacyt, commented:

"In 2021, we delivered a financial performance in line with expectations, excluding our ongoing dispute with the DHSC. This highlighted the agility of the Company to rapidly respond to the changing marketplace for our products, with a noticeable increase in demand from the private market for COVID-19 testing in travel, sport, film, media, and workplace settings.

"During my first 100 days as Chief Executive Officer of Novacyt I have undertaken a holistic review of the business and I am pleased to deliver my preliminary findings. We remain committed to becoming a leading, global clinical diagnostics company in the fight against infectious diseases, which will be enabled by strengthening the team, our core business and enhancing our position as a "global first responder" to outbreaks of novel pathogens. We will also endeavour to streamline our R&D programme to ensure we are keenly focused on commercially attractive opportunities and bringing the right solutions, to the right customers at the right time. We will also re-evaluate how we leverage our products in each of our target global markets as we continue on our path of international expansion.

"I am convinced, as I was when I joined Novacyt in October 2021, that the Company has the key ingredients in place to build towards the next phase of growth and will continue making a significant contribution to global health while delivering value to our shareholders. As we invest in non-COVID-19 product development to tackle high unmet needs and bolster our business development efforts, I am excited about the future for Novacyt as a strengthened organisation with a clear strategic focus."

Financial highlights

· Underlying revenue for FY2021 was £95.8m, compared to £277.2m for FY2020, excluding £40.8m of DHSC revenues under contractual dispute, as previously announced, in line with management guidance of approximately £100m

· Revenue derived from COVID-19 products accounted for 86% in FY2021, compared to 95% in FY2020

· As announced in August 2021, the year saw a significant shift away from large, centralised contracts towards independent testing, focused on private laboratories and non-governmental organisations (NGOs)

o Private laboratory revenues increased by 98% year-on-year from £28.3m to £55.9m, which includes £10.5m of revenue from NGOs

o Private testing accounted for 58% of FY2021 revenue at £55.9m, compared to 10% in FY2020 at £28.2m

o The UK represented 45% of total revenue in FY2021 at £42.7m versus 79% in FY2020 at £219.4m

· Group gross margin before exceptional items is expected to be in the region of 70%

· FY2021 EBITDA before exceptional items is expected to be above £36.0m (FY2020: £176.1m), i.e. a margin greater than 37%, in line with management guidance of approximately 40%

· The Company's cash position at 31 December 2021 was £101.8m, compared to £91.8m at 31 December 2020 and £77.2m at 30 June 2021

Operational highlights

· Rapid development and launch of 15 new assays to support laboratories, clinicians, and private testing of COVID-19 since the beginning of 2021

· Launch of VersaLab™ mobile processing laboratories and VersaLab™ Portable to expand near-patient testing opportunities in private sector testing

· Inclusion in National Framework Agreement, resulting in a new £4.7m contract with the DHSC for the supply of PROmate® COVID-19 tests to the NHS

· Secured new contracts with WHO and UNICEF for the supply of COVID-19 products

· Growth of new markets for private testing, including travel, sport, film, media, and workplace settings

· Focus on surveillance programme ensuring, to date, the Company's PCR product portfolio remains able to detect all published strains of SARS-CoV-2 with the same high level of accuracy

o This includes the most recent variant of concern, Omicron, which is fast becoming the global dominant strain

· David Allmond appointed as Chief Executive Officer and strengthened executive team and commercial operations to support future growth

Initial findings and conclusions from strategic review

Since joining on 18 October 2021, David Allmond has conducted an initial strategic review of the business during his first 100 days as Chief Executive Officer and provides the following key findings. Novacyt has already begun implementing several of the findings from this initial review and intends to expand further on the strategy at the time of its 2021 full year results.

The Company's refined vision is to become a leading, global clinical diagnostics company in the fight against infectious diseases through the three previously announced pillars of product portfolio expansion, geographic expansion and business development. The Company aims to achieve this vision by:

· Strengthening the team and Company's core business to become a sustainable foundation for growth and continuing to drive innovation

o The core business will consist of COVID-19 and non-COVID-19 in-vitro diagnostics (IVDs), life sciences/research-use-only (RUO) products, and instrumentation

· Maintaining Novacyt's position as a "global first responder" to rapidly address significant disease outbreaks through testing and market surveillance

o Novacyt has a track record of speed and agility to deliver critical products, as demonstrated in its response to the COVID-19 pandemic, and previous outbreaks including Zika, H1N1 (swine flu), and Ebola

voda 25 januari 2022 08:17

0

Deel 2:

The Company will continue to invest in R&D to deliver new products in respiratory and other areas of high unmet need, which has been a core pillar of its ongoing strategy development since the start of the COVID-19 pandemic. However, it will shift from being a "development led" to a "market led" business, changing how success is measured at the Company from the number of products developed to building a greater understanding of its customers' needs and developing solutions to best meet them. As a consequence, plans have been put in place to conduct more comprehensive upfront market opportunity assessments prior to determining how best to invest to deliver value.

In addition, an international scientific advisory board, and in-country and therapeutic area advisory boards, are being established to assist with market surveillance and direction of future innovation. This is crucial as clinical development, regulatory hurdles, associated costs, and timelines have increased meaning it is important the Company is confident in future value creation before embarking on significant investment in development programmes. In the interim, Novacyt continues to build a strong pipeline of business development opportunities for partnership, licensing, and M&A to strengthen the business and accelerate growth.

Another key pillar of Novacyt's strategic development to date has been geographic expansion, with a focus on building direct sales, marketing, and distribution channels. This focus remains, with the Company now leveraging adjacent markets across Europe with CE marked products, and obtaining targeted registrations to enable sales in additional territories. Beyond its key target markets, the Company will also continue to strengthen and work with its international distributor network to support growth and ensure enhanced global reach for its IVD, RUO and instrumentation portfolios.

As the strategic review of the business continues, the Company is also reviewing the Lab21 and Microgen businesses and considering the merits of maintaining multiple company entities/names under the Novacyt Group umbrella versus a simplified business model and brand, which the Directors believe could be more impactful.

Changes to the Executive Leadership Team to support next phase of growth

Paul Oladimeji has assumed the newly created position of Group Head of Research and Development (R&D), effective from 1 January 2022. Paul is a specialist in nucleic-acid amplification technologies and a neuroscientist by training.

Bryan Close has been appointed Chief Operations Officer, effective from 17 January 2022. Bryan is a Chartered Engineer and brings significant experience within operations, supply chain, and project management gained over a 35-year long career.

Paul Eros, Chief Business Officer, retired at the end of 2021 after four years with the Company. Paul will continue to work with Novacyt on a consultancy basis, focused on business development.

Ongoing dispute with the DHSC

As previously disclosed, the business remains in dispute with the DHSC in relation to a supply contract entered into in Q4 2020. During the course of 2021, the Company endeavoured to show the underlying performance of the business by excluding any financial impact of the disputed revenue. At this time, the Company continues to engage with the DHSC to resolve the dispute and continues to believe it has strong grounds to assert its contractual rights.

2022 outlook

As observed over the last two years, and highlighted in the last two months, the course of this pandemic is unpredictable and so, therefore, is the predictability of testing demand. Currently, the Board expects COVID-19 reported sales could be reduced by around 50% in 2022, versus 2021, which will be partially offset by new non-COVID-19 products which will start to come onstream in Q4 2022.

In the UK, additional uncertainty around product availability has been caused by the implementation of the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA"), as previously announced. Whilst Novacyt has so far been successful in receiving approval for one product and having two added to the temporary protocol, eight products remain under review. The Company continues to engage with the UK Health Security Agency and will provide further updates on its tests still under review as appropriate.

The Board believes the Company is well positioned to accelerate investing in non-COVID-19 product development to tackle high unmet needs, expand international reach and bolster its business development efforts.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

www.voxmarkets.co.uk/rns/announcement...

voda 4 februari 2022 09:04

0

Novacyt S.A.

("Novacyt" or the "Company")

Long Term Incentive Plan

202 2 Performance Share Awards

Paris, France and Camberley, UK – 4 February 202 2 – Novacyt S.A. (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces that it is launching a new Performance Share Awards programme for executive
management as part of its new Long Term Incentive Plan (“LTIP”). This new LTIP replaces
the previous phantom share award scheme which ended in November 2020.The Board
has taken external advice to construct an LTIP which is in- line with peer group companies
and also competitive to attract and retain the best talent for the Company.

Shareholders approved the issue of options over new ordinary shares of €1/15 each in the
Company to employees at the Company’s combined general meeting held on 18 October
2021 . Under the terms of the LTIP , the Board will determine the percentage award for
each qualifying executive each year . The Board may, at its absolute discretion, decide to
reduce the total number of shares held under ana ward and/or seek to recover from a
p articipant s hares and/or cash that has already vested, been paid and/or been acquired
on the exercise of an option .

Voor meer, zie link.

novacyt.com/2022/02/04/long-term-ince...

voda 4 februari 2022 09:05

0

Hier nog de pdf.

Bijlage:

voda 15 februari 2022 17:19

0

Paris, France and Camberley, UK - 15 February 2022 - Novacyt S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that it was notified by Biosynex SA ("Biosynex") on 14 February 2022 that, as at 10 February 2022, Biosynex's holding in the Company on a voting and capital basis is 3.0012% (2,119,627 shares).

www.londonstockexchange.com/news-arti...

voda 17 februari 2022 08:40

0

Mailtje van Mandy:

Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Approval of the first d irect - to - PCR COVID - 19 test in the UK under CTDA legislation

Paris, France and Camberley, UK – 1 7 February 2022 – Novacyt (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces that the Company’s PROmate ® COVID - 19 2G Real - Time PCR test has been
approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus
Test Device Approvals) (Amendment) Regulations 2021 (“ CTDA ”).

The PROmate® COVID - 19 2G test is the first direct - to - PCR product to be added to the
CTDA register of approved products and is designed to detect two SARS - CoV - 2 targets
within ORF1ab in response to an increasing shif t from single - gene to multi - gene testing
solutions . Direct - to - PCR products remove the need for complex, manual or automated
extraction solutions and are designed to significantly improve laboratory workflow and
reduce costs. It also allow s testing to take place away from traditional, laboratory - based
settings due to simplicity and ease of use . Therefore, the PROmate ® COVID - 19 2G PCR
test is well suited for industries such as travel, sport, film, media, and workplace settings .
Th e validation of the PROmate® COVID - 19 2 G test follows the UK approval of the
Company’s COVID - 19 genesig ® Real - Time PCR test under the CTDA , as announced on 26
November 2021 . In addition, as previously announced, Novacyt’s PR Omate® COVID - 19
1G Real - Time PCR test , currently being supplied to the NHS under a National Microbiology
Framework, remains on the temporary protocol list ( due to expire on 28 February 2022 )
and t he Company awaits further updates on an additional seven products submitted to the
CTDA across its COVID - 19 testing portfolio.

David Allmond, Group CEO of Novacyt, commented:
“ Our PROmate ® COVID - 19 range offer s a unique combination of workflow efficiency ,
result s in as little as 80 minutes and exceptional clinical performance, optimised for both
our genesig ® q16 and q32 instruments. It provides total viral inactivation, with a ready -
prepared m ix containing internal control for run validity , meaning there is no need for a
category 2 laboratory to handle the live virus, thereby removing handling risk and bringing
the test nearer to patients . With this approval from the CTDA , we can continue to meet
the demand for high quality COVID - 19 testing in the U K. ”
– End

novacyt.com/wp-content/uploads/2022/0...

voda 18 februari 2022 17:14

0

Novacyt S.A.

("Novacyt" or the "Company")

Holdings in Company

Paris, France and Camberley, UK – 18 February 202 2 – Novacyt S.A. (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces that it was notified by Biosynex SA (“Biosynex”) on 1 8 February 2022 that, as
at 1 4 February 2022, Biosynex's holding in the Company on a voting and capital basis is
4.04 % ( 2,855 ,959 shares).

For further information, please refer to www.novacyt.com or contact:
Contacts
Novacyt SA
David Allmond, Chief Executive Officer
James McCarthy, Chief Financial Officer
+44 (0)1276 600081

novacyt.com/wp-content/uploads/2022/0...

voda 11 maart 2022 15:53

0

www.voxmarkets.co.uk/rns/announcement...

Paris, France and Camberley, UK - 11 March 2022 - Novacyt S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that it was notified by Biosynex SA ("Biosynex") on 10 March 2022 that, as at 7 march 2022, Biosynex's holding in the Company on a voting and capital basis is 5.54% (3,915,350 shares).

voda 15 maart 2022 16:01

0

Met dank aan poster Frietvet:

Rns! Director purchase!

www.voxmarkets.co.uk/rns/announcement...

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