Resultados finales
impulsor genético plc
("genedrive" o "la Compañía" o "el Grupo")
Resultados finales auditados
genedrive plc (AIM: GDR), la empresa de diagnóstico molecular cercano al paciente, anuncia sus resultados finales auditados para el año que finalizó el 30 de junio de 2023.
Aspectos financieros más destacados
· Pérdida para el año de 5.2 millones de libras esterlinas (2022: pérdida de 4.7 millones de libras esterlinas)
· Gasto en I+D de 3.9 millones de libras esterlinas (2022: 3.9 millones de libras esterlinas)
· Efectivo en el banco de 2.6 millones de libras esterlinas (2022: 4.6 millones de libras esterlinas)
Aspectos operacionales destacados
· Genedrive® MT-RNR1 ID Test receives positive final recommendation in NICE's Early Value Assessment programme
· Genedrive® MT-RNR1 commenced rollout in Greater Manchester hospitals
· Commercial distribution agreements for Antibiotic Induced Hearing Loss (AIHL) test in place covering Spain, France, Austria, Greece, Saudi Arabia, Kuwait, Turkey and the Netherlands
· UKCA marking achieved for new Genedrive® CYP2C19 pharmacogenetic test
· Benefiting from £1.2m multi-partner grant awarded for the validation of Genedrive® CYP2C19 ID Kit in time critical NHS settings. The Company is expected to receive c£0.2m directly
· The draft NICE guidance recommends CYP2C19 genotyping for clopidogrel treatment and Genedrive® CYP2C19 ID test modelled to be a clinically and cost-effective option. Final NICE recommendations pending
· Investor Placing Agreement of up to £5m secured with £2.3m drawn down during the year and a further £0.6m drawdown post year end
· Pre-submission process ongoing with the Food and Drug Administration ("FDA") to determine regulatory process and requirements to place AIHL into the American market
James Cheek, CEO of genedrive plc, said: "I'm excited to be part of a Company that is innovating pharmacogenetic testing by bringing the test closer to the patient thereby making a real difference in patients' lives and helping clinicians make quick insightful decisions that improve patient safety. We continue to develop and create solutions that challenge what is possible and improve patient outcomes."
Para más detalles contacte a:
impulsor genético plc | 44 0 161 989 0245 |
James Cheek: director ejecutivo / Russ Shaw: director financiero | |
Peel Hunt LLP (Asesor designado y asesor conjunto Broker) | 44 0 20 7418 8900 |
James Steel/Patrick Birkholm | |
Walbrook PR Ltd (Relaciones con inversores y medios) | +44 (0) 20 7933 8780 o GME@dhr-rgv.com |
ana dunphy | 44 0 7876 741 001 |
Acerca de genedrive plc (http://www.genedriveplc.com)
genedrive plc es una empresa de pruebas farmacogenéticas que desarrolla y comercializa una plataforma farmacogenética de bajo costo, rápida, versátil, fácil de usar y sólida en el punto de necesidad para el diagnóstico de variaciones genéticas. Esto ayuda a los médicos a acceder rápidamente a información genética clave que les ayudará a tomar las decisiones correctas sobre el medicamento o la dosis adecuados para un tratamiento eficaz. Con sede en el Reino Unido, la empresa está a la vanguardia del trabajo sobre farmacogenética en el punto de atención. La farmacogenética analiza cómo su genética afecta la capacidad de un medicamento para funcionar para usted. Por lo tanto, mediante el uso de la farmacogenética, los medicamentos pueden ser más seguros y eficaces. La compañía lanzó su producto estrella, el kit de identificación Genedrive® MT-RNR1, que es un cartucho desechable de un solo uso que evita el requisito de la logística de la cadena de frío al proporcionar kits de prueba de reactivos con temperatura estable para usar en su plataforma de prueba patentada. Esta prueba permite a los médicos tomar una decisión sobre el uso de antibióticos en 26 minutos, lo que garantiza que se brinde atención vital sin impacto negativo en la trayectoria del paciente.
La Compañía tiene una estrategia comercial clara centrada en acelerar el crecimiento mediante la maximización de las ventas en el mercado, la expansión geográfica y de cartera y las fusiones y adquisiciones estratégicas, y opera desde sus instalaciones en Manchester.
Declaración del presidente
Innovation for better health outcomes
This year has been both challenging and rewarding, the road to commercialisation of groundbreaking innovative products is long and challenging, due to the collection of data required and the sheer size of the NHS and funding complexities of Integrated Care Systems (ICS).
I am very pleased to see our Antibiotic Induced Hearing Loss (AIHL) test in routine use at multiple sites, although initially on a small scale, the Company is well positioned for geographical expansion and I am immensely proud that we have contributed to the prevention of hearing loss in infants, which when considered with the NICE EVA recommendation and the potential to generate significant savings for the NHS, sees us well poised to gain growing commercial traction in the coming year.
Our people have worked relentlessly on the successful development of the Genedrive® CYP2C19 ID test, which is our most complicated assay developed to date and was delivered in the shortest time frame. It was welcoming to see the draft guidance from NICE recommending that CYP2C19 genotyping should be used before clopidogrel administration in the management of ischemic stroke patients and our inclusion in their Diagnostics Assessment Programme is a remarkable achievement. The final NICE recommendation, which had previously been expected in December 2023, has recently been delayed with further details not yet available.
The DEVOTE programme, led by the University of Manchester (UoM), builds on the model of the previous successful UoM/genedrive partnership with the PALOH programme, which supported the development and evaluation of the NICE recommended Genedrive® MT-RNR1 ID Kit. The DEVOTE grant funding will see us benefit from access to the Acute Medicine Unit and reduce clinical validation costs that otherwise would have been fully borne by the Group.
During the year we have consistently advanced our efforts towards transforming the way in which certain personalised medicine can be delivered aiming to enhance health outcomes and bring about health economic benefits.
Gobernanza y personas
I was delighted to welcome James Cheek and Gino Miele to the Board both with effect from 11 September 2023. James brings extensive commercial and operational experience at a senior level through a successful career with established diagnostic companies and joined as Chief Executive Officer, replacing David Budd. I would like to thank David for his dedication and leadership over the past seven years and wish him every success for the future. Gino joined the Board as Chief Scientific Officer and has considerable experience in the development of molecular diagnostic technologies and systems and has been the R&D Director at genedrive since 2015 and its predecessor Epistem since 2011.
The Board continues its commitment to maintaining its own efficiency and competence, with an unwavering dedication to ensuring that our governance framework, internal controls, values, and culture are all in harmony with our strategic goals and the Company's objectives.
Our people are the lifeblood of the Company, and I want to express my gratitude to each and every one of them for their unwavering resilience, innovative spirit, and unyielding determination in both the development and delivery of our products.
Oportunidades
The Board continuously assesses the Group's requirements and funding options that would bridge the gap before revenue generation allows us to be self-sufficient. The Investor Placing Agreement entered into on 31 March 2023 provided a committed facility of up to £5m and to date the Group has received £2.9m (£2m initial payment and further payments of £0.3m in June, July and November 2023). Further drawdowns are conditional on meeting certain share trading criteria, which are set out in note 6 and were also set out in the Company's circular issued on 24 April 2023 and therefore further drawdowns cannot be considered as guaranteed. The Board is planning for an equity or debt raise in early 2024 to support the growth and development plans of the business and allow the Group to continue to operate as a going concern. The Group does expect to receive an R&D tax credit of c£0.8m in Q1 of 2024 which, if received, would extend the cash runway (absent any further funding received) towards the end of Q1 2024 and provide a longer window for our planned financing activities. The Group's current cash runway is limited; unaudited cash as at 23 November 2023 was £1m and further funding will be required in early 2024 in order to continue as a going concern. The further payment of £0.3m pursuant to the Investor Placing Agreement announced on 29 November 2023 is due to be received shortly.
We also remain active in our pursuit of non-dilutive funding, such as the DEVOTE programme and we have pushed ahead with commercial opportunities outside of the UK, appointing eight international distributors and achieving six product registrations. We are continuing to work closely with the NHS to secure specialist commissioning funding for our MT-RNR1 product, as well as finalising our 2024 sales strategy and distribution channel for our new CYP2C19 product. With our commercialisation strategy including the US, we have recently completed a pre-submission exercise with the FDA which has, with no predicate device, clarified what would be expected to fulfil for release in the US of our novel MT-RNR1 test. We are now looking at funding options to take us forward for FDA approval for the MT-RNR1 product, with substantially all of the exploratory groundwork completed we are ready to proceed to the next step. Future funding would also be required to support the ongoing development of the instrumentation allowing us to capitalise on our pharmacogenetic positioning in emergency care and add further tests to our existing menu.
Outlook
Our mission is to leverage our technology to facilitate the improvement of health outcomes and it is encouraging that we are now beginning to bear the fruits of our labour. The Group will need to raise further funds in early 2024 to allow us to continue to operate as a going concern and fulfil our mission.
The Company will remain focused on its strengths, with a strong research and development capability at the core of our company, we will continually strive to grow our innovative product offering by leveraging our extensive knowledge in developing novel in-vitro pharmacogenetic assays.
Our Genedrive® platform is at the forefront, offering efficient and speedy genetic testing solutions and has the capability to address molecular pharmacogenetics in critical care settings. By harnessing our extensive expertise in developing in-vitro molecular diagnostic assays for use in time-critical healthcare settings, coupled with the advantages of our evolving Genedrive® platform, our company is establishing itself as a pioneer in the implementation of pharmacogenetics within emergency care.
We continue to make progress for FDA approval of our MT-RNR1 product, the US represents a very important market opportunity. As there is no predicate product in the US, there is no defined pathway for us to follow. The FDA have been very supportive of our efforts throughout the process to date to bring this test to the US market.
Finally, I want to express my appreciation to you, our valued shareholders, as well as our staff and collaboration partners for your ongoing support.
Dr. Ian Gilham
Presidente
Revisión del director ejecutivo
Innovation in Point-of-Care pharmacogenetic diagnostics in Emergency Medicine
General
This year has marked significant progress in our efforts to revolutionise the delivery of pharmacogenetic testing and personalised medicine. We continue to seek out and address unmet clinical requirements, capitalising on our proficiency in developing in-vitro pharmacogenetic diagnostic assays.
The UKCA marking of the Genedrive® CYP2C19 test is testimony to this and the use of our point-of-care test will allow patients to be put on an optimised treatment plan much quicker than is currently possible. I would like to take this opportunity to whole heartedly thank the efforts of the entire team here at genedrive for turning this ambitious and challenging vision into a reality in an incredibly short time which is a real testament to the quality, ability and dedication that we have in the organisation.
It is a privilege for the Group to once again collaborate with our esteemed colleagues at the University of Manchester (UoM) and Manchester University NHS Foundation Trust (MFT) in developing time-critical genetic test solutions. The DEVOTE program is an amazing opportunity to engage with the NHS to demonstrate the effectiveness of a new diagnostic approach. Real time access to the Acute Medicine Unit has considerable value to the Group and the grant funding to genedrive and its partners allows us to expediate the ongoing product development and support the pathway to clinical validation of our Genedrive® CYP2C19 ID Kit. This level of clinical input and evaluation is increasingly required by regulatory authorities prior to marketing product especially in the EU.
Our AIHL test is the world's first pharmacogenetic test in an urgent neonatal point-of-care setting. It helps avoid lifelong deafness in infants that are genetically predisposed to the unintended toxic effects in the inner ear from certain antibiotics. The test delivers a diagnostic result in under 30 minutes and allows for alternative treatment selections depending on the genetic variant of the patient.
Last year the Company took the strategic decision of transferring instrument manufacturing operations to the UK and some assay manufacturing in-house, with a view to increase visibility and control of its processes. This cost beneficial action has resulted in elevated transparency and oversight, whilst enhancing the speed and flexibility in transportation and delivery, reducing the time-to-market and improving sustainability. Bringing our supply chain closer together, improves the Group's agility and resiliency, with both economic and environmental advantages. This was highlighted no better than in our ability to bring the CYP2C19 assay to market so quickly.
Rendimiento
Both genedrive and our UK distributor have made significant in-roads across both the Academic Health Science Networks and individual Trusts, we truly believe that the clinical argument has been won. The next step on our journey is to secure interim funding until the date that the specialist commissioning kicks in to support the adoption UK wide. In the meantime, we are not sitting still and continue to establish distributors outside of the UK. We are also funding several Key Opinion Leader presentation and discussions across Europe and beyond. Our commercial team has made solid progress in thirteen countries internationally as we find wider interest in our products and our company worldwide.
Outlook
Using genetic and genomic testing for diagnosis and treatment optimisation has seen a considerable upsurge in recent years. This surge is propelled by rapid advancements in scientific knowledge and technological innovation. I take great pride in witnessing genedrive as a front runner in this field.
Our developments have facilitated remarkable advancements in personalised medicine, making it possible to customise treatment strategies for patients.
We are pioneers in what we do, so there is no well-trodden path between our technological advances and the commercial benefits. The NICE recommendation for our AIHL test demonstrates the beneficial impact of the test to both patients and wider society, whilst simultaneous providing potential and substantial cost savings to the NHS and we see that as instrumental to our UK roll out and expansion into international market.
Our focus remains on pharmacogenetic testing as we continue to invest in product development focusing on maximising the benefits of our continually advancing Genedrive® platform, characterised by its compactness, user-friendliness, rapid results, precision, and cost-effectiveness, qualities that makes it well-suited for extensive adoption. We believe our products are uniquely positioned for time-critical pre-emptive pharmacogenetic testing in emergency care and we will continue to explore opportunities outside of MT-RNR1 and CYP2C19.
james la mejilla
Director General
Financial Review,en
Revenue for the year was £0.06m (2022: £0.05m) and continues to reflect the time required for our products to gain commercial traction. The MT-RNR1 test is in routine use in Greater Manchester, paving the way for other early adopters in the UK, whereas international revenues are dependent on product registration and language translation, which has been achieved post year end in six countries. Research and development costs were £3.9m (2022: £3.9m) as we prepared for the regulatory approval of our second molecular point of care assay effectively expanding our range of assays and developing a pipeline for future innovative products. Administration costs have been tightly managed reducing by £0.4m from the prior year to £1.4m (2022: £1.8m). The operating loss for the year was £5.2m (2022: £5.6m).
Costos e ingresos de financiamiento
Financing costs were £0.8m (2022: £0.02m) including a non-cash fair value adjustment in respect of the derivative financial instrument of £0.7m (2022: £nil) and financing income was £0.03m (2022: £nil)
Taxation
The tax credit for the year was £0.8m (2022: £1.0m). The Group investment in R&D falls within the UK Government's R&D tax relief scheme for small and medium sized companies where it meets the qualifying criteria and as the Group did not make a profit in the year it is collected in cash following submission of tax returns. The £0.8m is a receivable on the balance sheet at the year end and is lower than in the previous year due to reductions in the enhanced relief available from April 2023.
Recursos en efectivo
Net cash outflow from operating activities before taxation was £4.8m (2022: £5.8m). The operating loss cashflows were £4.9m (2022: £5.3m) with a working capital inflow of £0.1m (2022: outflow £0.4m) mainly due to the reduction in inventory.
El crédito fiscal recibido fue de 1.0 millones de libras esterlinas (2022: 1.2 millones de libras esterlinas) y se relaciona con el efectivo recibido en virtud del plan de desgravación fiscal de I + D del gobierno del Reino Unido.
Capital expenditure in the period was £0.05m (2022: £0.06m) and the proceeds from investment funding, net of transaction costs were £2.0m (2022: £6.7m). The decrease in cash for the year was £2.0m (2022: £2.0m increase) meaning a closing cash position of £2.6m (2022: £4.6m).
Our unaudited cash balance as at the 23 November 2023 was £1.0m, reflecting a monthly burn rate of £0.4m since the year end. The further payment of £0.3m pursuant to the Investor Placing Agreement announced on 29 November 2023 is due to be received shortly.
Oportunidades
Requiring additional funding to finance the development of the CYP2C19 project and commercialisation of AIHL, the Company entered into an Investor Placing Agreement of up to £5m on 31 March 2023, of which £2.3m was drawn down in the year to 30 June 2023 and a further £0.6m since then. Further details can be found in note 6.
The Company also continues to actively seek non-dilutive funding and participation in the DEVOTE programme will see the Company receive c£0.2m and avoid a further c£1.0m of costs that would otherwise have been absorbed by the Company for the validation and verification of our CYP2C19 product.
Hoja de balance
Los activos netos del balance al 30 de junio de 2023 eran de 2.0 millones de libras esterlinas (2022: 5.6 millones de libras esterlinas). Los activos fijos fueron de 0.4 millones de libras esterlinas (2022: 0.2 millones de libras esterlinas) e incluyen el derecho a usar activos de arrendamiento de 0.2 millones de libras esterlinas (2022: 0.02 millones de libras esterlinas).
Los activos corrientes de £4.1 millones (2022: £6.4 millones) incluyeron efectivo de £2.6 millones (2022: £4.6 millones). Los inventarios de 0.5 millones de libras esterlinas (2022: 0.7 millones de libras esterlinas) consistían principalmente en materias primas utilizadas en la fabricación y la I+D. El resto de los valores actuales de los activos estaban en cuentas por cobrar de £0.2 millones (2022: £0.1 millones) e impuestos. El impuesto a cobrar era de 0.8 millones de libras (2022: 1.0 millones de libras esterlinas) para la reclamación fiscal de investigación y desarrollo del impuesto de sociedades del año en curso.
Current liabilities were £2.4m (2022: £1.0m) and include a derivative financial instrument £1.3m (2022: £nil) resulting from the Investor Placing Agreement, as set out in note 6.
The shares to be issued reserve of £0.5m (2022: £nil) relates to the warrants issued as part of the Investor Placing Agreement.
Los activos netos cerraron en £2.0 millones (2022: £5.6 millones). La pérdida integral del año fue de 5.2 millones de libras esterlinas (2022: 4.7 millones de libras esterlinas).
Preocupación continua
As outlined in the Chairman's statement, the Group and Company needs to bridge the funding gap before revenue generation allows us to be self-sufficient. The Board is actively considering financing options. This short-term funding requirement is partly as a result of the uncertainty of further drawdowns from the Investor Placing Agreement which are conditional on certain factors including the Company's share price. The Company remains in close dialogue with the investors, further drawdowns would extend the cash runway and therefore the timeline for our planned financing activities. The Group does also expect to receive an R&D tax credit of c£0.8m in Q1 of 2024 which, if received, would extend the cash runway (absent any further funding received) towards the end of Q1 2024 and provide a longer window for our planned financing activities. As well as equity or debt financing we are also actively seeking non-dilutive funding such as grants, funding partners for the FDA approval and charitable organisations willing to support the adoption of our quality-of-life enhancing innovations.
We are beginning to gain commercial traction, RNR1 is in routine use at a small number of hospitals and with the appointment of international distributors, language packs and registrations complete, we are confident that significant revenues will follow. NHS specialist commissioning would expediate this, but as we are not in control of the process, there is uncertainty as to the timing.
The NICE EVA (Early Value Assessment) recommendation supports our belief that our RNR1 test quickly and accurately identifies babies, who may be at risk of hearing loss if given aminoglycoside antibiotics, allowing equally effective alternative antibiotics to be used instead and that the long-term savings to the NHS associated with hearing loss and fitting cochlear implants could be substantial.
As described in the accounting policies, we continue to adopt a going concern basis for the preparation of the accounts, but the combination of the above factors represent a material uncertainty that may cast significant doubt on the Group and Company's ability to continue as a going concern.
Russ Shaw
Director Financiero
Declaración consolidada de ingreso comprensivo
para el año terminado el 30 de junio de 2023
Note | Año terminado 30 junio 2023 000 £ | Año terminado 30 junio 2022 000 £ | |
Operaciones continuas |
| ||
Ingresos | 2 | 55 | 49 |
Costos de investigación y desarrollo. | (3,924) | (3,871) | |
Costes administrativos | (1,355) | (1,793) | |
Pérdida operativa | (5,224) | (5,615) | |
Costos financieros | 3 | (757) | (16) |
Pérdida de actividades ordinarias antes de impuestos | (5,981) | (5,631) | |
Taxation | 4 | 831 | 956 |
Pérdida del ejercicio | (5,150) | (4,675) | |
Pérdida / gasto integral total del ejercicio | (5,150) | (4,675) | |
Pérdida por acción (peniques) |
| ||
- Básico y diluido | 5 | (5.5p) | (5.5p) |
Hoja de balance consolidado
al 30 de junio de 2023
Note | 30 junio 2023 000 £ | 30 junio 2022 000 £ | |
Activos | |||
Activos no corrientes | |||
Propiedad, planta y equipo. | 392 | 206 | |
392 | 206 | ||
Activos circulantes |
| ||
Los inventarios | 525 | 748 | |
Cuentas comerciales y otras cuentas por cobrar | 158 | 107 | |
Contraprestación contingente por cobrar | - | 15 | |
Activo por impuesto corriente | 831 | 956 | |
Efectivo y equivalentes de efectivo | 2,601 | 4,589 | |
4,115 | 6,415 | ||
| |||
los activos totales | 4,507 | 6,621 | |
| |||
Pasivos |
| ||
Pasivo circulante |
| ||
Comerciales y otras cuentas a pagar | (935) | (994) | |
Pasivos por arrendamiento | (222) | (16) | |
Instrumentos financieros derivados | 6 | (1,290) | - |
(2,447) | (1,010) | ||
Pasivos no corrientes |
| ||
Pasivos por arrendamiento | (19) | - | |
Pasivos totales | (2,466) | (1,010) | |
Activos netos | 2,041 | 5,611 | |
Equidad |
| ||
Capital social solicitado | 7 | 1,485 | 1,388 |
Otras reservas | 8 | 52,777 | 51,294 |
Perdidas acumuladas | (52,221) | (47,071) | |
Equidad total | 2,041 | 5,611 |
Estado de cambios en el patrimonio neto consolidado
para el año terminado el 30 de junio de 2023
Compartir 000 £ | Otro 000 £ | Acumulado pérdidas 000 £ | Total 000 £ | |
Saldo al 30 de junio de 2021 | 950 | 45,000 | (42,358) | 3,592 |
Transacciones con propietarios en su calidad de propietarios: | ||||
Compartir asunto | 426 | 6,186 | - | 6,612 |
Emisión de acciones - consideración diferida | 8 | (8) | - | - |
Pagos basados en acciones liquidados mediante acciones | 4 | 116 | (38) | 82 |
Transacciones liquidadas directamente en patrimonio | 438 | 6,294 | (38) | 6,694 |
Pérdida integral total del año | - | - | (4,675) | (4,675) |
Saldo al 30 de junio de 2022 | 1,388 | 51,294 | (47,071) | 5,611 |
Transacciones con propietarios en su calidad de propietarios: | ||||
Compartir asunto | - | 2 | - | 2 |
Acuerdo de financiación de inversiones, neto de costos de transacción | 97 | 1,385 | - | 1,482 |
Pagos basados en acciones liquidados mediante acciones | - | 96 | - | 96 |
Transacciones liquidadas directamente en patrimonio | 97 | 1,483 | - | 1,580 |
Pérdida integral total del año | - | - | (5,150) | (5,150) |
Saldo al 30 de junio de 2023 | 1,485 | 52,777 | (52,221) | 2,041 |
Estado de flujo de efectivo consolidado
para el año terminado el 30 de junio de 2023
Note | Año terminado 30 junio 2023 000 £ | Año terminado 30 junio 2022 000 £ | |
flujos de efectivo por actividades operacionales | |||
Pérdida operativa del año | (5,224) | (5,615) | |
Depreciación, amortización y deterioro | 61 | 63 | |
Depreciación, activos por derecho de uso | 193 | 187 | |
Pagos basados en acciones | 96 | 38 | |
Pérdida operativa antes de cambios en el capital de trabajo | (4,874) | (5,327) | |
Disminución / (aumento) de inventarios | 223 | (192) | |
(Aumento) / disminución de cuentas por cobrar comerciales y otras | (51) | 51 | |
Disminución de cuentas por pagar comerciales y otras | (59) | (292) | |
Salida neta de efectivo de las actividades operativas antes de impuestos | (4,761) | (5,760) | |
Impuesto recibido | 956 | 1,166 | |
Salida neta de efectivo de las actividades operativas | (3,805) | (4,594) | |
Flujos de efectivo de actividades de inversión | |||
Ingresos financieros | 29 | - | |
Costos financieros | - | (16) | |
Adquisición de planta y equipo | (52) | (62) | |
Ingresos por enajenación de operaciones discontinuadas | 15 | 107 | |
Efectivo neto (salida) / entrada de actividades de inversión | (8) | 29 | |
Flujos de efectivo de actividades de financiación | |||
Producto del acuerdo de colocación de inversiones | 6 | 2,300 | - |
Costos de transacción relacionados con el acuerdo de colocación de inversiones | (283) | - | |
Ingresos de la emisión de acciones | - | 7,200 | |
Transaction costs relating to share issue | - | (506) | |
Reembolso de los pasivos por arrendamiento | (193) | (119) | |
Entrada neta por actividades de financiación | 1,824 | 6,575 | |
Neto (disminución) / aumento de equivalentes de efectivo | (1,989) | 2,010 | |
Efectos de los cambios en el tipo de cambio en efectivo y equivalentes de efectivo | 1 | 5 | |
Efectivo y equivalentes de efectivo al inicio del año | 4,589 | 2,574 | |
Efectivo y equivalentes de efectivo al final del año | 2,601 | 4,589 | |
Análisis de fondos netos | |||
Efectivo en banco y en mano | 2,601 | 4,589 | |
El efectivo neto | 2,601 | 4,589 |
Notas a la información financiera
para el año terminado el 30 de junio de 2023
Información general
genedrive plc ('la Compañía') es una compañía constituida y domiciliada en el Reino Unido. La oficina central registrada es The CTF Building, Grafton Street, Manchester M13 9XX, Reino Unido.
genedrive plc y sus subsidiarias (en conjunto, 'el Grupo') es una empresa de diagnóstico molecular que desarrolla y comercializa una plataforma de diagnóstico de punto de necesidad o de atención de bajo costo, rápida, versátil, fácil de usar y sólida para el diagnóstico de enfermedades infecciosas y para su uso en la estratificación de pacientes (genotipado), detección de patógenos y otras indicaciones.
genedrive plc es una sociedad anónima cuyas acciones cotizan en el Mercado de Inversiones Alternativas de la Bolsa de Valores de Londres.
1. Políticas contables importantes
La información financiera del ejercicio finalizado el 30 de junio de 2022 se ha extraído de los estados financieros estatutarios auditados del Grupo que fueron aprobados por el Consejo de Administración el 18 de noviembre de 2022 y que se han entregado al Registro de Sociedades de Inglaterra y Gales. El informe del auditor sobre estos estados financieros no tenía salvedades, no contenía una declaración en virtud de la Sección 498(2) o la Sección 498(3) de la Ley de Sociedades de 2006.
El informe del auditor sobre los estados financieros legales del 30 de junio de 2023 no tenía salvedades, no contenía una declaración en virtud de la Sección 498(2) o la Sección 498(3) de la Ley de Sociedades de 2006, pero llamó la atención sobre la capacidad del Grupo para continuar como un negocio en marcha a través de un párrafo de incertidumbre material.
La información incluida en este anuncio ha sido preparada sobre la base de empresa en marcha bajo la convención de costo histórico modificada por la revaluación de activos financieros y pasivos financieros (incluidos los instrumentos derivados) a valor razonable a través de ganancias o pérdidas, y de acuerdo con las normas adoptadas por el Reino Unido. Estándares de Contaduría Internacional.
La información de este anuncio ha sido extraída de los estados financieros legales auditados para el año que finalizó el 30 de junio de 2023 y, como tal, no constituye estados financieros legales en el sentido de la sección 435 de la Ley de Sociedades de 2006, ya que no contiene toda la información. deben ser revelados en los estados financieros preparados de acuerdo con Adoptado por el Reino Unido Estándares de Contaduría Internacional.
This announcement was approved by the board of directors on 29 November 2023 and authorised for issue via RNS.
Preocupación continua
The Group's business activities, market conditions, principal risks and uncertainties along with the Group's financial position are described in the full annual accounts. The Group funds its day-to-day cash requirements from existing cash reserves and drawdowns from the Investor Placing Agreement, which are subject to certain conditions as described in note 6. These matters have been considered by the Directors in forming their assessment of going concern.
The Directors have concluded that it is necessary to draw attention to the revenue and cost forecasts in the business plans during the period to June 2025. The Group and Company does not currently have sufficient cash resources to continue as a going concern during the forecast period due to the time expected to be needed to gain commercial traction in its revenues. Therefore, the Company will need to raise further equity, or other funding, in early 2024 in order to continue as a going concern. The forecasts prepared by the Directors include a plan to raise additional funds from equity investors or debt providers in early 2024 to allow the Company to continue as a going concern.
The Company is confident that given the health benefits and economics that RNR1 will be a commercial success. The NICE EVA (Early Value Assessment) recommendation is testimony to it. Our CYP2C19 product is now at validation and verification stage and has a much larger potential market than RNR1 with a far less complex route to market. The Company recognises the uncertainty regarding the timing of the associated revenues, given we are first to market for RNR1 and the funding complexities within the NHS. NICE recommendations and Specialist Commissioning will bring significant upside to our sales forecasts, but they are outside of our control and are therefore uncertain. The Directors have reasonable confidence in their ability to raise additional funds given the progress described above and having made enquiries, have a reasonable expectation that the Group has access to adequate resources to continue in operational existence for the foreseeable future.
Si bien la Junta tiene un historial exitoso en la recaudación de fondos, sigue existiendo incertidumbre en cuanto a la cantidad de financiamiento que podría recaudarse de los accionistas o proveedores de deuda. La combinación de los factores anteriores representa una incertidumbre material que puede generar dudas significativas sobre la capacidad del Grupo y la Compañía para continuar como una empresa en funcionamiento.
En consecuencia, los Directores han concluido que es apropiado continuar adoptando la base contable de negocio en marcha en la preparación de estos estados financieros. Estos estados financieros no incluyen los ajustes que resultarían si el Grupo y la Compañía no pudieran continuar como un negocio en marcha.
2. Segmentos operativos
Para la elaboración de informes internos y la toma de decisiones, el Grupo está organizado en un segmento, Diagnóstico. Diagnostics comercializa Genedrive® plataforma de pruebas moleculares en el punto de necesidad. En períodos futuros, y a medida que crezcan los ingresos, el Grupo puede revisar la información de la cuenta de gestión por tipo de ensayo y, por lo tanto, dividir los Diagnósticos en segmentos; sin embargo, por ahora, el segmento único es apropiado.
El máximo responsable de la toma de decisiones operativas se basa principalmente en la facturación y la pérdida operativa para evaluar el desempeño del Grupo y tomar decisiones sobre los recursos que se asignarán a cada segmento. Los factores geográficos son revisados por el responsable de la toma de decisiones operativas, pero dado que prácticamente todas las actividades operativas se llevan a cabo en el Reino Unido, la geografía no es un factor significativo para el Grupo. En consecuencia, solo las ventas se han analizado en declaraciones geográficas.
Los resultados de la división operativa del Grupo se detallan a continuación.
Segmentos de negocio | Diagnóstico segmento 000 £ | Sector empresarial costos 000 £ | Total 000 £ |
Año terminado el 30 de junio de 2023 | |||
Ingresos | 55 | - | 55 |
Pérdida operativa | (3,869) | (1,355) | (5,224) |
Costos financieros netos | (757) | ||
Pérdida de actividades ordinarias antes de impuestos | (5,981) | ||
Taxation | 831 | ||
Pérdida del ejercicio | (5,150) | ||
Gasto integral total del año | (5,150) |
Segmentos de negocio | Diagnóstico segmento 000 £ | Sector empresarial costos 000 £ | Total 000 £ |
Año terminado el 30 de junio de 2022 | |||
Ingresos | 49 | - | 49 |
Pérdida operativa | (3,822) | (1,793) | (5,615) |
Costos financieros netos | (16) | ||
Pérdida de actividades ordinarias antes de impuestos | (5,631) | ||
Taxation | 956 | ||
Pérdida del ejercicio | (4,675) | ||
Gasto integral total del año | (4,675) |
Diagnóstico segmento 000 £ | Sector empresarial costos 000 £ | Total 000 £ | |
Año terminado el 30 de junio de 2023 | |||
Activos del segmento | 960 | 3,547 | 4,507 |
Pasivos por segmento | (877) | (1,589) | (2,466) |
Año terminado el 30 de junio de 2022 | |||
Activos del segmento | 1,003 | 5,618 | 6,621 |
Pasivos por segmento | (905) | (105) | (1,010) |
Adiciones a activos no corrientes: segmento de diagnóstico £ 353 mil (2022: £ 124 mil) y costos corporativos £ 88 mil (2022: £ 31 mil).
Segmentos geográficos
Las operaciones del Grupo están ubicadas en el Reino Unido. La siguiente tabla proporciona un análisis de los ingresos del Grupo por ubicación del cliente:
Todo sobre operaciones continuas | Año terminado 000 £ | Año terminado 000 £ |
Reino Unido | 35 | 37 |
Europa | 16 | 10 |
Estados Unidos de América | 4 | 2 |
Resto del mundo | - | - |
55 | 49 |
Revenues from three customers accounted for more than 10% of total revenue in the current year (2022: two).
3. Ingresos / (costos) financieros - neto
Año terminado 000 £ | Año terminado 000 £ | |
Ingresos por intereses de depósitos bancarios | 30 | - |
Transaction costs relating to investment placing agreement (note 6) | (81) | - |
Movement in fair value of derivative financial instrument (note 6) | (675) | - |
Costos de arrendamiento financiero | (31) | (16) |
(757) | (16) |
4. Impuestos
(a) Reconocido en el estado de resultados
Impuesto corriente: | ||
Año terminado 000 £ | Año terminado 000 £ | |
Créditos fiscales para investigación y desarrollo | (831) | (956) |
Crédito fiscal total del año | (831) | (956) |
(b) Conciliación del crédito fiscal total
The tax credit assessed on the loss for the year is lower (2022: lower) than the weighted average applicable tax rate for the year ended 30 June 2023 of 20.5% (2022: 19.0%). The differences are explained below:
Año terminado 000 £ | Año terminado 000 £ | |
Pérdida antes de impuestos sobre operaciones continuadas | (5,981) | (5,631) |
Impuesto utilizando la tasa del impuesto de sociedades del Reino Unido del 20.5 % (2022: 19.0 %) | (1,226) | (1,070) |
Ajuste con respecto al crédito fiscal por I + D reclamado | (295) | (412) |
Partidas (imponibles) para efectos fiscales - permanentes | 140 | (7) |
Partidas no deducibles a efectos fiscales: temporal | (2) | (3) |
Impuesto diferido no reconocido | 686 | 703 |
Diferencias de tarifas | (134) | (167) |
Crédito fiscal total del año | (831) | (956) |
No se reconocen activos por impuestos diferidos al 30 de junio de 2023 (2022: £ cero). Habiendo revisado la rentabilidad futura en el contexto de las pérdidas comerciales acumuladas, no es probable que haya suficientes ganancias disponibles para compensar las pérdidas anticipadas.
El Grupo tuvo pérdidas comerciales, calculadas a efectos fiscales, de aproximadamente 21,676 miles de libras esterlinas (2022: 19,032 miles de libras esterlinas) disponibles para traspasar a períodos futuros; esto excluye los gastos de gestión.
5. Beneficio por acción
2023 000 £ | 2022 000 £ | ||
Pérdida del año después de impuestos | (5,150) | (4,675) |
Grupo procesos | 2023 Número | 2022 Número |
Número medio ponderado de acciones ordinarias en emisión | 94,165,295 | 84,860,240 |
Acciones ordinarias potencialmente dilutivas | - | - |
Promedio ponderado ajustado de acciones ordinarias en emisión | 94,165,295 | 84,860,240 |
Pérdida por acción en operaciones continuas | ||
- Básico | (5.5) p | (5.5) p |
- Diluido | (5.5) p | (5.5) p |
La utilidad básica por acción se calcula dividiendo la utilidad atribuible a los accionistas ordinarios del año por el número promedio ponderado de acciones ordinarias emitidas durante el año.
Como la Compañía tiene pérdidas, no se han agregado opciones potencialmente dilutivas al cálculo de EPS. Si la Compañía hubiera obtenido ganancias en el período:
Grupo procesos | 2023 | 2022 |
Potentially dilutive shares from share options and warrants | 1,163,817 | 971,238 |
Acciones potencialmente dilutivas dentro del SIP | 339,967 | 208,703 |
Acciones ordinarias potencialmente dilutivas | 1,503,784 | 1,179,941 |
6. Derivative Financial Instruments
On 31 March 2023, the Company entered into an Investor Placing Agreement for up to £5m with RiverFort Global Opportunities PCC Limited ("Noteholders"). The instrument was entered by way of an initial drawdown in the amount of £2m and related issuance of 6,250,000 shares priced at nominal value of 1.5 pence to be used to facilitate the settlement of amounts advanced under the investment agreement. A further drawdown was made in June 2023 of £0.3m and the remaining balance as at the balance sheet date of £2.7m under the Facility is available for the Company to drawdown, at its discretion, but subject to there being no trading Material Adverse Change:
(a) the Share Price falling below 16 pence
(b) the 3 day average volumes traded being less than £100,000
(c) the 10 day average trading volumes being less than £100,000 and
(d) the amount outstanding under the Facility being no more than £700,000;
Any outstanding liability after the disposal by the Noteholder of the shares issued in exchange for each drawdown can be settled at the discretion of the Noteholder by further subscription to the Company's shares. The Company can also elect to settle the outstanding liability with a 10% premium on the balance. As the value of the outstanding amount is expected to move with the Company's share price, the instrument met the definition of a derivative and is initially recognised at fair value with changes in fair value recognised in profit and loss.
Pursuant to the facility, the Noteholders were granted warrants exercisable at 41.6p to subscribe for 2,500,000 ordinary shares and were granted warrants exercisable at 24.607p to subscribe for 682,731 ordinary shares. All warrants remain outstanding at 30 June 2023 and can be exercised at any time from the date of issue for a period of four years.
The warrants are initially valued using a model which utilised observable market factors such as the share price at the date of the grant, the term of the award, the share price volatility and the risk-free interest rate (Level 2 inputs).
The Company made drawdowns of £2.3m during the financial year which can be summarised as follows:
Pasivo financiero derivado 000 £ | Finanzas costos 000 £ | Equidad 000 £ | Warrants 000 £ | Total 000 £ | |
Producto | 615 | - | 1,117 | 568 | 2,300 |
Los costos de transacción | - | (81) | (191) | (91) | (363) |
615 | (81) | 926 | 477 | 1,937 | |
Movimiento de valor razonable | 675 | ||||
Al 30 de junio de 2023 | 1,290 |
Transaction costs include fees of £80,000 payable to the Noteholders that were settled by issue of shares and included in share premium (note 8).
7. Capital social
Asignado, emitido y pagado en su totalidad:
Número | 000 £ | |
Saldo al 30 de junio de 2021 | 63,320,048 | 950 |
Emisión de acciones: pagos basados en acciones liquidados con instrumentos de patrimonio | 271,546 | 4 |
Emisión de acciones - consideración diferida | 500,000 | 8 |
Compartir asunto | 28,450,852 | 426 |
Saldo al 30 de junio de 2022 | 92,542,446 | 1,388 |
Emisión de acciones: pagos basados en acciones liquidados con instrumentos de patrimonio | 7,500 | - |
Compartir asunto | 6,500,000 | 97 |
Saldo al 30 de junio de 2023 | 99,049,946 | 1,485 |
El 1 de octubre de 2021, la Compañía emitió 28,450,852 6.6 XNUMX acciones como parte de una oferta abierta y de colocación a los accionistas por ingresos netos de £XNUMX millones.
El 10 de diciembre de 2021, la Compañía emitió 500,000 acciones en genedrive plc al antiguo propietario de Visible Genomics como parte de una Escritura de Modificación acordada en diciembre de 2018 al Acuerdo de Compraventa de Visible Genomics.
On 3 April 2023 the Company issued 6,500,000 shares with a nominal value of £97,000 as part of the Investor Placing Agreement detailed in note 6.
8. Otras reservas
Compartir cuenta premium 000 £ | Acciones a emitir 000 £ | Plan de incentivos de acciones para empleados 000 £ | Compartir 000 £ | Reserva de adquisición inversa 000 £ | Equidad total 000 £ | |
Saldo al 30 de junio de 2021 | 46,055 | 115 | (196) | 1,522 | (2,496) | 45,000 |
Emisión de acciones - consideración diferida | 107 | (115) | - | - | - | (8) |
Compartir asunto | 6,264 | - | - | - | - | 6,264 |
Pagos basados en acciones liquidados mediante acciones | - | - | - | 38 | - | 38 |
Transacciones liquidadas directamente en patrimonio | 6,371 | (115) | - | 38 | - | 6,294 |
Saldo al 30 de junio de 2022 | 52,426 | - | (196) | 1,560 | (2,496) | 51,294 |
Investment funding arrangement (note 6) | 910 | 477 | - | - | - | 1,387 |
Pagos basados en acciones liquidados mediante acciones | - | - | - | 96 | - | 96 |
Transacciones liquidadas directamente en patrimonio | 910 | 477 | - | 96 | - | 1,483 |
Saldo al 30 de junio de 2023 | 53,336 | 477 | (196) | 1,656 | (2,496) | 52,777 |
Shares to be issued relates to the warrants issued; full details are contained in note 6.
The employee share incentive plan reserve is the historic cost of shares purchased to satisfy share rights under the Share Investment Plan ("SIP") of £196k. The Company no longer buys shares to satisfy the SIP.
The reverse acquisition reserve arises as a difference on consolidation under merger accounting principles and is solely in respect of the merger of the Company and Epistem Ltd, during the year ended 30 June 2007.
9. Contabilizar eventos relacionados con el balance
The Company made two £0.3m drawdowns under the Investor Placing Agreement (note 6) and issued 724,997 and 1,614,669 warrants to the Noteholders in July 2023 and November 2023 respectively.
The Company signed the DEVOTE funding grant post year end.
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