nieuws Novacyt

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

Trading Update

Paris, France and Camberley, UK – 9 April 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an
update on its supply contract with the UK Department of Health and Social Care (DHSC)
and provides an unaudited trading update for the three months ended 31 March 2021.

DHSC contract

On 29 September 2020, Novacyt announced a second supply contract with the DHSC for
exsig® COVID-19 Direct kits and other products. In the full year trading update
announced on 29 January 2021, Novacyt explained it was in active discussions with the
DHSC regarding an extension of the supply contract. Unfortunately, an extension has not
been agreed, although the Company supplied PROmate™ in Q1 2021 in accordance with
DHSC demand. Regrettably, the parties are now in dispute regarding the contract, which
may have a material impact on Q4 2020 revenues. However, the Company has taken legal
advice and believes it has strong grounds to assert its contractual rights.

Q1 trading update and 2021 outlook

Novacyt delivered revenue for Q1 2021 of €83.0 million (£72.6 million). Approximately
50% of Q1 revenue was driven by sales to the DHSC, predominately PROmate™. The
remaining c.50% of Q1 revenue was driven by continued growth of international sales and
expansion of the Company’s private sector testing operations.

Given the ever-changing nature of the COVID-19 pandemic and diagnostic testing
demands, the Company continues to have limited visibility over future sales. Whilst the
Directors are confident new contract wins will continue as Novacyt expands international
sales and into private sector testing, they believe revenue and profit for 2021 may be
lower than current market expectations due to the absence of the DHSC contract
extension.

Novacyt expects PROmate™ to continue to be rolled out in hospitals, private sector
settings and international markets for the foreseeable future, although the Company
believes that Q1 PROmate™ sales may be sufficient to support the NHS current roll out
plans for the remainder of 2021.

The Company is encouraged by demand for its mobile processing laboratories and SNPsig®
portfolio, both launched in Q1 2021, for private sector testing and detection of COVID-19
variants, respectively. New COVID-19 lateral flow products are also under development,
to expand the Company’s ability to meet evolving COVID-19 testing demands.

The Directors believe the Company remains well-positioned to capitalise on future growth
opportunities as it continues to expand its product portfolio and service offering.

The information contained within this Announcement is deemed by the Company to
constitute inside information as stipulated under Article 7 of the Market Abuse Regulation
(EU) No. 596/2014 (as amended) as it forms part of the domestic law of the United
Kingdom by virtue of the European Union (Withdrawal) Act 2018 (as amended). Upon the
publication of this Announcement via the Regulatory Information Service, this inside
information is now considered to be in the public domain.
- End -

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Thu, 22nd Apr 2021 07:00

RNS Number : 2784W
Novacyt S.A.
22 April 2021

Novacyt S.A.

("Novacyt" or the "Company")

Update on Notice of 2020 Full Year Results

Paris, France and Camberley, UK - 22 April 2021 - Novacyt S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that following the announcement on 9 April 2021, the Company now intends to report its audited financial results for the year ended 31 December 2020 on 29 June 2021.
- End -

Novacyt SA

Graham Mullis, 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

Numis Securities Limited (Joint Broker)

Freddie Barnfield / James Black

+44 (0)20 7260 1000

Allegra Finance (French Listing Sponsor)

Rémi Durgetto / Yannick Petit

+33 (1) 42 22 10 10

r.durgetto@allegrafinance.com; y.petit@allegrafinance.com

FTI Consulting (International)

Victoria Foster Mitchell / Alex Shaw / Mary Whittow

+44 (0)20 3727 1000

victoria.fostermitchell@fticonsulting.com / alex.shaw@fticonsulting.com / mary.whittow@fticonsulting.com

FTI Consulting (France)

Arnaud de Cheffontaines

+33 (0)147 03 69 48

arnaud.decheffontaines@fticonsulting.com

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Met dank aan poster Opstapelen:

R&D update, nice

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Paris, France and Camberley, UK – 23 April 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an
update on the progress of its near-term COVID-19 research and development (R&D)
programmes to address rapidly evolving testing demands, particularly as SARS-CoV-2
continues to mutate around the world. Novacyt also provides an update on its UK
operations.
R&D highlights
• Expansion of PathFlow® lateral flow test (LFT) portfolio with COVID-19 tests
o Launch of LFT to detect SARS-CoV-2 IgG antibodies
o Development of LFT to detect and differentiate between SARS-CoV-2 IgG
antibodies, launch expected Q3 2021
o Development of LFT to detect antigens for SARS-CoV-2, launch expected by
end of Q2 2021
• Expansion of genesig® COVID-19 polymerase chain reaction (PCR) portfolio
o Launch of CE Mark three-gene target PCR test
• Expansion of PROmate™ COVID-19 PCR portfolio for workflow efficiency in a nearto-patient setting
o Development of two-gene target test, launch expected May 2021
o Launch of test to identify a key mutation, E484K, found in all current
variants of concern (VOC)
• Expansion of SNPsig® COVID-19 PCR genotyping portfolio to detect SARS-CoV-2
variants
o Launch of CE Mark VariPLEX™ assay panel to detect multiple variants
o Development of test to detect a variant originally identified in India, launch
expected week commencing 26 April 2021
UK operational highlights
• Expansion of UK commercial infrastructure
• Inclusion in Public Health England (PHE) National Framework Agreement
Graham Mullis, Chief Executive Officer of Novacyt, commented:
“The continued development and expansion of our COVID-19 portfolio demonstrates
Novacyt’s ability to match the rapid evolution of SARS-CoV-2 with real-time bioinformatics
surveillance and accelerated product development. 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 innovator in diagnostic testing.
“We are also pleased to be included in the PHE national framework, which allows PHE and
NHS hospitals to purchase our accredited products without the need for direct contract
awards. We look forward to the opportunity to expand our support of diagnostic testing in
the UK through our established infrastructure and building a long-term future in this
important market, as well as in international markets as we continue to invest in our direct
commercial operations.”
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Novacyt S.A.
("Novacyt", the "Company" or the "Group")
Novacyt to support UNICEF with donation of one million COVID-19 tests

Donation supports testing efforts to help ensure continued access to essential services for children and their families
Paris, France and Camberley, UK – 4 May 2021 – Novacyt S.A. (EURONEXT GROWTH:

ALNOV; AIM: NCYT; “Novacyt”), an international clinical diagnostics company, will donate one million COVID-19 polymerase chain reaction (PCR) tests to UNICEF to help contain the spread of the virus through testing.

All over the world, the COVID-19 pandemic has upended the lives of children and their families. During this time, UNICEF has provided support to the most vulnerable children, working to safeguard their access to education, nutrition and essential health services. At the same time, UNICEF acts as a key partner and lead procurer for the Access to COVID19 Tools Accelerator (ACT-A), a global collaboration to speed up the development, production and equitable access to COVID-19 tests, treatments and vaccines.

By supporting ACT-A, UNICEF aims to help combat the COVID-19 pandemic, potentially save the lives of frontline workers and high-risk populations, make health systems more resilient and ultimately, help ensure that children in low- and middle-income countries survive and thrive.

As the world accelerates vaccination efforts against COVID-19, testing remains an important part of global efforts to contain the virus. Novacyt’s donation will help UNICEF work with governments to fill gaps in COVID-19 testing capacities. This, in turn, will help to ensure children and their families continue to have access to essential services and
care.

Novacyt will send the test kits to countries where there is both the need and infrastructure to perform PCR testing. The first four countries whose Ministries of Health have expressed interest and capacity to receive the test kits are Nigeria, Palestine, Maldives, and South Sudan.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“We are proud to support UNICEF and the incredible initiatives it has in place to protect children around the world during the pandemic. There remains a need to contain the spread of COVID-19, not just in high-income countries but on a global scale. Novacyt is committed to playing our part in fighting the pandemic by delivering reliable testing for
the virus where it is most needed. We are delighted to be working with UNICEF to support low- and middle-income countries in their response to COVID-19, which will in turn enable access to vital services for children affected by one of the largest ever humanitarian crises.
Finally, I am proud of the Novacyt team, as without their dedication and focus the Company would not be in the position it is today, allowing us to support global organisations like UNICEF.”

Clarence Jaccard-Briat, General Director at UNICEF France, added:

“We are grateful for the contribution Novacyt is providing to UNICEF’s role in COVID-19 testing. Our efforts to fight the pandemic won’t stop until every child and every family is safe and in good health. Through ACT-A and the COVAX Facility, UNICEF, along with partners, is on a historic mission to vaccinate the world. We invite other partners to join us and support us in this race to end COVID-19. Because no one is safe until everyone is safe.”
- End -

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

Inclusion of SNPsig® SARS-CoV-2 PCR genotyping
portfolio in the NHS England Framework and expansion of SNPsig® product range

Paris, France and Camberley, UK – 17 May 2021 – Novacyt (EURONEXT GROWTH:

ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that the
Company’s SNPsig® SARS-CoV-2 polymerase chain reaction (PCR) genotyping portfolio
has been included in the NHS England Framework for detecting Variants of Concern (VoC).
Novacyt also announces the launch of two new PCR assays to detect SARS-CoV-2 VoC.

• Detecting known VoC Framework, announced by NHS England on 14 May 2021,
includes the Company’s SNPsig® SARS-CoV-2 PCR genotyping portfolio as one of
the four companies selected by NHS England. This national framework is for testing
of all positive SARS-CoV-2 samples from NHS (pillar 1) and high throughput
Lighthouse (pillar 2) laboratories in England.

• SNPsig® COVID-19 (20I/501Y.V1 + E484K) is a CE Marked assay to detect
20I/501Y.V1, the VoC originally identified in the UK, VOC-21FEB-02 and all SARSCoV-2 variants carrying the E484K escape mutation.

• SNPsig® SARS-CoV-2 (E484K) Easy is a research-use-only, streamlined
workflow solution for the detection of SARS-CoV-2 variants carrying the E484K
escape mutation for use with the Company’s q32 rapid-PCR instrument. This assay
comes with pre-filled cassettes and includes only one pipetting step to decrease
operator complexity and improve cycle times.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“We are very pleased to be included in NHS England’s VoC Framework, which allows our
SNPsig® range of products to be used at any NHS and Lighthouse laboratories, subject to
local verification, as we continue to support diagnostic testing across the UK, and globally,
through our extensive portfolio. We remain committed to developing new tests to match
the rapid evolution of the SARS-CoV-2 virus with our real-time bioinformatics surveillance
programme and accelerated product development. Our SNPsig® portfolio for detecting
Variants of Interest and Variants of Concern now includes 12 individual assays to support
scientists and clinicians in the ongoing fight against COVID-19.”


About the E484K mutation
The E484K mutation has appeared independently in several VoC, indicating an
evolutionary advantage for SARS-CoV-2
1
. Multiple studies have shown an association with
reduced antibody neutralisation in both natural and vaccine-elicited human sera2
-
4
. Early
detection of the E484K mutation is critical to ensure a rapid public health response.
About SNPsig® COVID-19 (20I/501Y.V1 + E484K)
The subpopulation of 20I/501Y.V1 carrying the E484K mutation was first detected in the
Southwest of England and was first known as the Bristol Variant. This VoC, now named as
VOC-21FEB-02, has been detected predominantly in the UK. In addition to the observed
increase in transmissibility detected for 20I/501Y.V1, the E484K mutation provides this
VoC with potential for antibody escape. SNPsig® COVID-19 (20I/501Y.V1 + E484K) is a
product that combines the detection of both the VoC 20I/501Y.V1 and the clinically
significant mutation E484K, allowing the identification of not only 20I/501Y.V1 and VOC21FEB-02 positive cases, but also the presence of E484K in one assay.

About SNPsig® SARS-CoV-2 (E484K) Easy
SNPsig® SARS-CoV-2 (E484K) Easy is a rapid direct solution based on the Company’s
simplified PROmate workflow, to detect the E484K mutation in SARS-CoV-2 variants in
less than 90 minutes using the Company’s q32 instrument.

About the SNPsig® portfolio
Novacyt's bioinformatics surveillance group remains highly vigilant and, as new biologically
significant mutations are identified, these will continue to be added to the SNPsig®
portfolio. A recent study reported in the medRxiv5
, the preprint server for health sciences, demonstrates the high potential of the SNPsig® portfolio to detect the most significant mutations, VoCs and variants. The portfolio is described below:

Voor meer, zie link:

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

DHSC Dispute Update

Paris, France and Camberley, UK – 21 May 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an
update to its ongoing dispute with the Department of Health and Social Care ("DHSC").

On 9 April 2021, Novacyt announced that it was in dispute with the DHSC in relation to its
second supply contract and that this may have a material impact on Q4 2020 revenues.
In the same announcement it was also noted that approximately 50% of Q1 2021 revenue
was driven by sales to the DHSC. The dispute may now have a material impact on these
Q1 2021 revenues from the DHSC.

The Company has taken legal advice in relation to the dispute and believes it has strong
grounds to assert its contractual rights.

The information contained within this Announcement is deemed by the Company to
constitute inside information as stipulated under Article 7 of the Market Abuse Regulation
(EU) No. 596/2014 (as amended) as it forms part of the domestic law of the United
Kingdom by virtue of the European Union (Withdrawal) Act 2018 (as amended). Upon the
publication of this Announcement via the Regulatory Information Service, this inside
information is now considered to be in the public domain.

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

Launch of VersaLab™ Portable

Paris, France and Camberley, UK – 26 May 2021 – Novacyt (EURONEXT GROWTH:

ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the
expansion of its VersaLab™ portfolio with the launch of VersaLab™ Portable to provide an
additional level of support in near-patient testing environments.

VersaLab™ was launched in December 2020 to support private sector testing of infectious
diseases, initially focused on COVID-19. Novacyt added to the VersaLab™ portfolio in
March 2021 with the launch of VersaLab™ mobile processing laboratories.

Novacyt believes that VersaLab™ Portable is an important addition to its commercial
strategy as the Company looks to expand its reach in private sector testing, especially in
overseas markets. The product is a “PCR lab in a box” and as such comes with all the
equipment required to provide near-patient PCR testing using Novacyt’s PROmate™
workflow in non-clinical settings, such as offices and workplaces.

VersaLab™ Portable has been designed specifically with a focus on small to medium
organisations, which represent a growing market opportunity for Novacyt. Other potential
applications include sport events and facilities, education facilities, the leisure industry,
humanitarian bases and retail.

PROmate™ is the only rapid direct-to-PCR COVID-19 assay approved by the Department
of Health and Social Care’s Technology Validation Group. PROmate’s™ unique workflow
allows Novacyt to provide rapid results to patients in under 80 minutes, saving time and
minimising the risk of infection spreading.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“When we launched VersaLab™ our aim was to bring PCR technology closer to patients.
The initial market response to the portfolio is encouraging and the Company looks to
increase its promotion during the second half of 2021. With VersaLab™ Portable we can
broaden access to affordable testing in areas that lack the infrastructure of laboratorybased testing whilst still providing optimum results from gold standard PCR reagents. We believe that VersaLab™ Portable can support organisations, including small to medium businesses, offer onsite testing as lockdowns begin to ease internationally.”

End

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

Launch of two new PCR COVID-19 assays

Paris, France and Camberley, UK – 3 June 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the
launch of two new polymerase chain reaction (PCR) assays, expanding its genesig®
COVID-19 and SNPsig® SARS-CoV-2 variant detection portfolios.

• genesig® COVID-19 3G is a CE-Marked three-gene assay to detect the ORF1ab,
M gene, and S gene targets of SARS-CoV-2, enabling fulfilment of certain
international testing requirements, including Fit to Fly Certificate, Test to Release
and US Food and Drug Administration regulations.

• SNPsig® EscapePLEX SARS-CoV-2 is a first-to-market assay panel in a single kit
able to detect the four most critical SARS-CoV-2 mutations currently recognised,
combined with a confirmatory two-gene assay for COVID-19. The research-useonly kit detects the biologically significant ‘escape’ mutations E484K, K417N, K417T and P681R, present in the Alpha, Beta, Gamma and Delta Variants1 of Concern
(VoC), and also incorporates the two gene (ORF1ab and M) assay to provide a confirmatory detection of SARS-CoV-2.

Novacyt’s genesig® portfolio is a well-established range of PCR kits for pathogen detection.
The new three-gene assay for COVID-19 has been developed in recognition of rapidly
changing testing needs dictated by SARS-CoV-2 mutations and complements the
Company’s existing one-gene, two-gene, and high-throughput tests. The Company aims
to capture a wider share of the growing global travel market for COVID-19 testing with
the three-gene test.

The SNPsig® portfolio is initially focused on detecting the most significant mutations, VoC
and variants of SARS-CoV-2 and currently includes 13 assays. The Company believes the
SNPsig® EscapePLEX SARS-CoV-2 will be crucial in helping clinicians and public healthcare
centres globally identify SARS-CoV-2 mutations which can impact transmissibility,
immunity, and infection severity2
.
Graham Mullis, Chief Executive Officer of Novacyt, commented:
“The success of our COVID-19 PCR assays has been built around robust design principles
and our real-time bioinformatics surveillance programme to monitor new SARS-CoV-2
genome sequences. As a result, our genesig® COVID-19 portfolio is highly accurate despite
mutations, and we believe our SNPsig® portfolio is the world’s largest for detecting SARSCoV-2 variants. The addition of both of these new assays ensures that Novacyt’s COVID

1 www.who.int/en/activities/tracking-SA...
2 www.ecdc.europa.eu/en/covid-19/varian...

19 solutions remain robust and that pragmatic options are available to support both public
health and private sector testing alike.”
End

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(er is nog meer, zie link)
Popina
0
quote:

voda schreef op 3 juni 2021 08:36:


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

Launch of two new PCR COVID-19 assays

Paris, France and Camberley, UK – 3 June 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the
launch of two new polymerase chain reaction (PCR) assays, expanding its genesig®
COVID-19 and SNPsig® SARS-CoV-2 variant detection portfolios.

• genesig® COVID-19 3G is a CE-Marked three-gene assay to detect the ORF1ab,
M gene, and S gene targets of SARS-CoV-2, enabling fulfilment of certain
international testing requirements, including Fit to Fly Certificate, Test to Release
and US Food and Drug Administration regulations.

• SNPsig® EscapePLEX SARS-CoV-2 is a first-to-market assay panel in a single kit
able to detect the four most critical SARS-CoV-2 mutations currently recognised,
combined with a confirmatory two-gene assay for COVID-19. The research-useonly kit detects the biologically significant ‘escape’ mutations E484K, K417N, K417T and P681R, present in the Alpha, Beta, Gamma and Delta Variants1 of Concern
(VoC), and also incorporates the two gene (ORF1ab and M) assay to provide a confirmatory detection of SARS-CoV-2.

Novacyt’s genesig® portfolio is a well-established range of PCR kits for pathogen detection.
The new three-gene assay for COVID-19 has been developed in recognition of rapidly
changing testing needs dictated by SARS-CoV-2 mutations and complements the
Company’s existing one-gene, two-gene, and high-throughput tests. The Company aims
to capture a wider share of the growing global travel market for COVID-19 testing with
the three-gene test.

The SNPsig® portfolio is initially focused on detecting the most significant mutations, VoC
and variants of SARS-CoV-2 and currently includes 13 assays. The Company believes the
SNPsig® EscapePLEX SARS-CoV-2 will be crucial in helping clinicians and public healthcare
centres globally identify SARS-CoV-2 mutations which can impact transmissibility,
immunity, and infection severity2
.
Graham Mullis, Chief Executive Officer of Novacyt, commented:
“The success of our COVID-19 PCR assays has been built around robust design principles
and our real-time bioinformatics surveillance programme to monitor new SARS-CoV-2
genome sequences. As a result, our genesig® COVID-19 portfolio is highly accurate despite
mutations, and we believe our SNPsig® portfolio is the world’s largest for detecting SARSCoV-2 variants. The addition of both of these new assays ensures that Novacyt’s COVID

1 www.who.int/en/activities/tracking-SA...
2 www.ecdc.europa.eu/en/covid-19/varian...

19 solutions remain robust and that pragmatic options are available to support both public
health and private sector testing alike.”
End

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(er is nog meer, zie link)


Dag Voda, mag ik jou eens mailen? Heb je mailadres voor me? Dank alvast
voda
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Novacyt S.A.

("Novacyt" or the "Company")

Update on Notice of 2020 Full Year Results

Paris, France and Camberley, UK – 18 June 2021 – Novacyt S.A. (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces that it will report its audited financial results for the year ended 31 December
2020 on Tuesday 22 June 2021.

The Company has changed its reporting currency from Euro to Great British Pounds (GBP)
for these results, and will report in GBP going forward, as the cost base of the business is
now mainly located in the UK and GBP is the largest invoicing currency for sales. The
results for the year ended 31 December 2019 will be restated to GBP to provide the same
currency comparison.
- End -

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voda
0
quote:

Popina schreef op 15 juni 2021 14:28:


[...]

Dag Voda, mag ik jou eens mailen? Heb je mailadres voor me? Dank alvast

Natuurlijk kan dat, zie het nu pas.
Mijn mail adres is (alles aan elkaar) voda30001 @gmail.com
voda
0
Novacyt S.A.

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

Full year 2020 results and update on growth strategy

Transformational performance in 2020

Continued strong demand for COVID-19 testing in 2021

Strategy to deliver long-term growth through test, instrument, and
geographic expansion in key areas, supplemented by M&A

Paris, France and Camberley, UK – 22 June 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces its
audited results for the year ended 31 December 2020 and provides an update on its growth
strategy.

Graham Mullis, Group CEO of Novacyt, commented:
“2020 was a year of transformation for Novacyt as we responded to the worldwide spread
of COVID-19. Historically, we have built a reputation for the innovation and high
performance of our diagnostic technologies, which allowed us to rapidly respond to the
pandemic through the development of a reliable COVID-19 PCR testing portfolio. As a
result of supporting an urgent global demand for PCR testing, the future of Novacyt has
been secured, having repaid all long-term debt, significantly strengthened the balance
sheet, and delivered on a number of strategic objectives to support future growth.
“As the COVID-19 testing market has continued to evolve in 2021, we have continued to
strengthen our core capabilities and apply our bioinformatics and design expertise to
expand our product offering. We therefore expect to see Novacyt continue to play a major
role in COVID-19 testing and, specifically, we expect to see strong revenue growth in
private testing as markets and international travel re-opens.
“As we look to build on our solid foundations, and develop Novacyt into a major diagnostics
player, we have updated our strategy for delivering long-term growth with a refined focus
in key areas of test, instrument, and geographic expansion. We will also continue to
supplement these growth initiatives through our M&A strategy. The Board believes that
Novacyt is well positioned to create sustainable, long-term value.
“I would like to extend my sincere gratitude to all of our employees for their ongoing hard
work and dedication, as well as our partners and suppliers for their loyalty throughout
2020 and so far in 2021 as we continue the fight against COVID-19. Finally, I would like
to thank our shareholders, long-standing and new, who continue to support Novacyt.”

Voor veel meer, zie link:

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Post balance sheet event / DHSC Dispute

On 9 April 2021, Novacyt announced it was in dispute with the DHSC in relation to its
second supply contract and made a further update on 21 May 2021. The dispute primarily
relates to Q4 2020 revenue totalling £129.1m in respect of a specific product supplied to
the NHS. The Company has taken independent legal advice and a provision has been made
in the financial statements with the Board’s estimate at this time in respect of this claim
with DHSC.

The Board has formed a judgment that, in accordance with the contractual terms, and if
required, it should be possible to replace the product in dispute and a product warranty
provision has been made accordingly. The Board’s best estimate of the cost to replace is
up to a maximum of £19.8m, the timing of any outflow is dependent on settlement of the
dispute. If no settlement is achieved and legal action is required, the timing of any possible
outflow will be extended.

It is possible, but not probable, that the DHSC’s claim for a refund under the limited
assurance warranty will be successful. The timing of any cash outflow is dependent upon
the success of the claim and the terms negotiated for repayment. If the resolution of the
claim is materially different from the Board’s determination of replacing the product, the
financial statements with regard to revenue and the provision for product warranty could
be significantly impacted.

Of the Q4 2020 revenue, invoices amounting to £24.0m in respect of product delivered to
the DHSC remain outstanding at the date of signing the financial statements and recovery
of this amount is also dependent on the outcome of the dispute. In addition, after the
year-end, a further £49.0m of product delivered and invoiced to the DHSC in 2021 remains
unpaid and is now also part of the dispute. The unpaid invoices total £73.0m and include
VAT.

At this time, the Company is unable to provide further clarification on the dispute or the
timing of resolution due to the confidential nature of discussions underway. However, the
Company has taken legal advice in relation to the dispute and believes it has strong
grounds to assert its contractual rights.
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Trading update and outlook for the remainder of 2021

For the five months ended 31 May 2021, the Company had unaudited sales of £88.4m
compared to £40.8m for the same period in 2020. This £88.4m includes £40.7m of sales
to the DHSC, which are part of the dispute. Excluding the DHSC, the Company saw a runrate of over £10m in sales per month in Q1 2021, which has declined to approximately £7m per month in April and May as infection rates eased and testing has dropped sharply.
This is a repeat of the trend seen in 2020 as countries moved into the summer period and
the spread of COVID-19 declined.

Looking forward, the Company expects strong growth in private testing as markets and
travel re-open, which could lead to higher infection rates, and an increase in testing to
return in Q4 2021, in line with Q4 2020, during the winter period. The Company also
expects to see significant new growth from the launch of new products during the second
half of 2021, including an expansion of its lateral flow antigen testing portfolio for both
professional and home use. If demand picks up in line with expectations, the Company
expects to see full year sales of approximately £100m, excluding the sales to the DHSC
which are in dispute.

In the first five months of 2021, Novacyt has delivered a gross margin of over 70% and
an EBITDA margin of over 40%, excluding the impact of sales to the DHSC, and the
Directors are confident the Company can maintain these levels of underlying profitability
for the balance of the year if volumes are in-line with its current expectations. This
assumes no further sales to the DHSC for the balance of the year and no further provisions
or adjustments relating to the current dispute.

By combining a broad technology base with agile and innovative product development and
a clinical trial functionality, the Board believes the Company is well positioned to rapidly
address new areas of unmet need with market leading products. The R&D outlook for 2021
is strong, with a number of new products in development that will continue to meet the
rapidly changing requirements of COVID-19 testing and address the broader non-COVID19 respiratory, transplant and infectious disease markets. This is underpinned by a strengthened cash position and the business will continue to invest in innovation, organic expansion, and external business development, in line with its growth strategy. The
Company also continues to evaluate M&A opportunities and will consider additional bolton acquisitions to add strategic assets and expand its geographic footprint.
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Novacyt S.A.
("Novacyt", the "Company" or the "Group")
Expansion of PathFlow® COVID-19
lateral flow test portfolio

Paris, France and Camberley, UK – 29 June 2021 – Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is to launch two
PathFlow® COVID-19 antigen lateral flow tests (LFTs) to strengthen the Company’s COVID19 portfolio and to pursue significant new market opportunities, especially in point-of-care
(POC) settings. The Company will initially target private market opportunities for these
LFTs via its existing distribution network.

Novacyt’s two new PathFlow® COVID-19 antigen tests are small, instrument-free and
contain all the components required for safe sample collection, preparation, testing,
interpretation of results, and disposal for convenient use by healthcare professionals or
patients in home settings. The use of point-of-care testing is a first line rapid screening
option and, therefore, Novacyt’s PathFlow® antigen LFTs complement the Company’s
existing polymerase chain reaction (PCR) portfolio for SARS-CoV-2 diagnosis.

PathFlow® COVID-19 Rapid Antigen Pro is a CE Marked LFT for professional
use detecting SARS-CoV-2 antigens using either anterior nasal samples or
nasopharyngeal samples to provide results in approximately 15 minutes. When
using nasal swab specimens, the test demonstrated a sensitivity of 93.5% and
specificity of 99.3% and when using nasopharyngeal swab specimens, it
demonstrated sensitivity of 93.4% and specificity of 99.4%. Both sampling
methods were tested against 316 samples. This product is available immediately.

PathFlow® COVID-19 Rapid Antigen is a self-test LFT to detect SARS-CoV-2
antigens using oral fluid samples and provides results in approximately 15 minutes.
This test demonstrated a sensitivity of 90.1% and specificity of 99.3% from 303
clinical samples. The test offers mass screening for home, travel, events, and
workplace markets. Novacyt expects to make this LFT available as a CE Marked
product shortly.

PathFlow® COVID-19 Rapid Antigen Pro and PathFlow® COVID-19 Rapid Antigen have been
developed with a partner through an OEM agreement in conjunction with Novacyt’s
Microgen Bioproducts division.

Graham Mullis, Chief Executive Officer of Novacyt, commented:
“Throughout the pandemic we have continued to launch new products to ensure our
COVID-19 portfolio remains at the forefront of our industry. These two antigen LFTs will
support our customers as the market continues to evolve towards private testing and we
believe they will become a useful entry point to our existing range of PCR COVID-19 tests.
With the potential for a flu season starting in the northern hemisphere in a few months it
will be important to know whether a person has flu or SARS-CoV-2 and having access to
quick results are critical to patient treatment and containing the spread of the COVID-19
virus. These LFTs add to our existing PathFlow® range, which is a portfolio for the rapid
diagnosis of a number of infectious diseases, and we will continue to evaluate other
COVID-19 POC tests to meet the changing demands of the market.”

novacyt.com/wp-content/uploads/2021/0...
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David Allmond announced as CEO following decision by Graham Mullis to retire

Paris, France and Camberley, UK – 29 July 2021 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), a leading international specialist in clinical diagnostics, announces the appointment of David Allmond as CEO and a member of the Board of Directors effective from 18 October 2021. At that time Graham Mullis, having informed the Board that he wishes to retire after 13 years with the expanded Group, will stand down as CEO and board member.

Voor meer, zie pdf.

novacyt.com/2021/07/29/david-allmond-...

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