Informe de medio año
impulsor genético plc
("genedrive" o la "Compañía")
Resultados intermedios a 31 de diciembre de 2023
genedrive plc (LSE: GDR), the point of care pharmacogenetic testing company, announces unaudited interim results for the six months to 31 December 2023.
PUNTOS DESTACADOS OPERATIVOS (incluido el período posterior)
· Food and Drug Administration ("FDA") progress for the Genedrive® MT-RNR1 pharmacogenetic test (Antibiotic Induced Hearing Loss). The Company is in advanced stages of negotiating a collaboration with a USA-based Medical Group to support a highly cost-effective pathway for the necessary clinical trials
· Distributor agreement in place to support the FDA study and support future sales in the United States
· NIHR i4i & OLS Real World Evidence Programme funding application to address NICE EVA evidence generation requirements for the Genedrive® MT-RNR1 kit, in partnership with lead partners at Manchester University NHS Foundation Trust and 14 hospitals throughout the UK
· Strategic decision to sell Genedrive® MT-RNR1 kit direct in the UK and Ireland in 2024 following addition of increased internal sales capability
· Royal Sussex County Hospital, Brighton adopts the Genedrive® MT-RNR1 ID Kit for routine use and ongoing discussions with other hospitals in the UK and Ireland with further near-term adoption anticipated
· Initial international sales of the Genedrive® MT-RNR1 ID Kit received from France, Austria, Greece, Saudi Arabia, Turkey and the Netherlands
· UK Conformity Assessed ("UKCA") marking achieved for new Genedrive® CYP2C19 pharmacogenetic test (stroke treatment selection)
· £1.2m (of which the Company is expected to receive c£0.2m directly) multi-partner grant awarded and in progress for the validation of Genedrive® CYP2C19 ID Kit in time critical NHS settings
· The draft NICE guidance recommends CYP2C19 genotyping for clopidogrel treatment and Genedrive® CYP2C19 ID test modelled to be a clinically and most dominant cost-effective option. The second consultation on the draft guidance is scheduled to commence on 3 April 2024 and the final NICE recommendations are expected to be published in July 2024
ASPECTOS FINANCIEROS MÁS DESTACADOS
· Revenue and other income of £0.24m (H1 2022/3: £0.02m)
· R&D spend of £1.9m (H1 2022/3: £2.0m)
· Operating loss of £2.4m (H1 2022/3: £2.7m)
· Cash of £1.2m as at 31 December 2023 (30 June 2023: £2.6m)
· Cash of £1.2m as at 20 March 2024 following recent receipt of R&D tax credit of £0.8m
James Cheek, CEO of genedrive plc, commented: "Following my arrival in September I have seen the organisation really move forward with our commercial enterprises and it has been encouraging to see how we have been able to generate Genedrive® MT-RNR1 kit sales both inside and outside the UK in such a short space of time. As well as our commercial focus, I have also been keen to ensure we have the right strategy for our business overall, leading to tighter controls over costs. I said in November, that for MT-RNR1, we would have a new UK site on board soon, sales coming in from overseas and a distributor in place to help us move forward with our desire to sell into the much larger USA market (subject to FDA approval). This has all been achieved and my focus going forward is on continuing with our MT-RNR1 sales, especially outside of the UK, as well as building our marketing and sales for CYP2C19 in the UK. Finally, we will seek to raise further equity funding in the coming weeks in order to provide a longer-term financing solution for the Company's exciting growth plans. On behalf of myself and the Board, I would like to thank our shareholders for their support and I look forward to what I hope will be a prosperous year."
impulsor genético plc | 44 0 161 989 0245 |
James Cheek: director ejecutivo / Russ Shaw: director financiero | |
Peel Hunt LLP (Asesor designado y 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 |
About genedrive
genedrive plc is a pharmacogenetic testing company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need pharmacogenetic platform for the diagnosis of genetic variations. This helps clinicians to quickly access key genetic information that will help them make the right choices over the right medicine or dosage to use for an effective treatment. Based in the UK, the Company is at the forefront of work on Point of Care pharmacogenetics. Pharmacogenetics looks at how your genetics impacts a medicines ability to work for you. Therefore, by using pharmacogenetics, medicines can be made safer and more effective. The Company has launched its flagship product, the Genedrive® MT-RNR1 ID Kit, which is a single-use disposable cartridge that circumvents the requirement for cold chain logistics by providing temperature stable reagent test kits for use on their proprietary test platform. This test allows clinicians to make a decision on antibiotic use within 26 minutes; ensuring vital care is delivered with no negative impact on the patient pathway.
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.
CHIEF EXECUTIVE OFFICER'S AND CHAIRMAN'S REPORT
The Company continues to make significant steps in revolutionising the delivery of personalised medicine, enhancing health outcomes and generating health economic benefits. There has been a renewed focus on our commercial team leading to changes in personnel and structure. This has allowed us to go direct in the UK and Ireland, enhance our digital marketing offering and increase our distributor network worldwide.
Pérdida auditiva inducida por antibióticos (AIHL) - Kit Genedrive® MT-RNR1-ID
Our MT-RNR1 ID kit is the world's first point-of-care genetic test to reduce the risk of antibiotic induced hearing loss ("AIHL"). Following detection of the MT-RNR1 variant an alternative antibiotic treatment can be prescribed. Our test has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to global healthcare systems.
In March 2023, the Genedrive® MT-RNR1-ID Kit received a recommendation for use in the UK by the National Institute for Health and Care Excellence ("NICE") under its Early Value Assessment Programme ("EVA"). The EVA was introduced to allow rapid assessment of digital products, devices and diagnostics for clinical effectiveness and value for money, so that the NHS and patients can benefit from these promising technologies sooner. The recommendation is conditional on further evidence being generated and the Company is a partner with clinical colleagues at Manchester University NHS Foundation Trust ("MFT") who have recently applied for funding to address the NICE EVA evidence generation recommendations, which are required for progressing the NICE conditional recommendation into a full recommendation at the earliest opportunity. The NIHR i4i & OLS Real World Evidence Programme is intended to address each eligible EVA, is being led by Office for Life Sciences ("OLS") as part of the UK Government's Life Sciences Vision and is backed by £10m of government funding and is expected to commence in October 2024.
Royal Sussex County Hospital, Brighton has adopted the Genedrive® MT-RNR1 ID Kit for routine use. This was a significant milestone, as it's the first adopter outside of Greater Manchester and plans are being put into place to roll out the test in the wider Kent, Surrey and Sussex region.
We continue to pursue all avenues to ensure we achieve specialist commissioning before the current timescale of April 2025. In line with specialist commissioning being devolved to the Integrated Care Boards ("ICBs"), our initial discussions have been with the Manchester ICB to obtain funding from April 2024 for the live sites across the Greater Manchester region.
In December 2023, following product registration and language translations, the first international sales of the Genedrive® MT-RNR1 ID Kit were achieved in France, Austria, Greece, Saudi Arabia, Turkey and the Netherlands and we have recently signed new distributors in Italy and the UAE.
The Company is at advanced stages in agreeing a partnership with a key strategic USA-based Medical Group with broad coverage of neonatal intensive care units nationally to progress our aim of introduction of our MT-RNR1 point of care pharmacogenetic test to the USA (subject to regulatory approval). If the partnership is secured it would provide the Company with a highly cost-effective pathway for the required regulatory studies for potentially attaining approval in the USA which would be a key element of the use of proceeds for the Company's proposed equity financing.
The USA is a particularly attractive market for this unique test, given its high birth rates, use of diagnostic testing and reimbursement structure and therefore has the potential to save many children from life-long deafness. In 2021, 3.7m babies were born in the USA, with approximately 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1m per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage and reduce potential litigation costs.
A distributor agreement is in place with International Biomedical, Ltd. to support the FDA study and future sales in the United States. International Biomedical has over 45 years' experience in the design, manufacture and distribution of neonatal and perinatal products and solutions, covering the entire USA.
Genedrive® CYP2C19 ID Kit
Genedrive® CYP2C19 ID Kit achieved UKCA marking registration in September 2023. It is a point of care pharmacogenomic test that can differentiate between patients that could respond to clopidogrel treatment and those that will not, allowing more effective drug treatment to be prescribed on a personalised basis. The test can be performed at the bedside or in a ward and can deliver a clinically actionable result in just over one hour.
Suboptimal response to clopidogrel following stroke is common, as reported by the NHS it is affecting up to 30% of patients in the general population, which increases to approximately 50%-60% in certain ethnic groups. In the UK, the National Institute for Health and Care Excellence ("NICE") recommended in May 2023 draft guidance that people who have had an ischaemic stroke or transient ischaemic attack ("TIA") should have a CYP2C19 genetic test prior to treatment. According to the World Stroke Organization, globally there are over 77 million people currently living who have experienced ischaemic stroke. It's estimated by the Stoke Association that there are 100,000 strokes in the UK each year.
The Genedrive® CYP2C19 test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, which are instrumental in the loss of metabolism function and poor activation of clopidogrel in a patient. The Genedrive® system automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. Like all genedrive products, the tests are presented in a room-temperature stable, freeze-dried format, allowing testing to be performed by healthcare workers, away from laboratory locations. In its performance evaluations, the test achieved 100% accuracy in detecting the variants that underpin loss of metabolism function.
The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") grant is providing acute care patient access and supporting infrastructure for the Company to assess the real-world clinical performance of time-critical clinical tests in an NHS setting. The 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 Genedrive® MT-RNR1 ID Kit. The Company is expected to receive circa £0.2m directly with the £1m balance funding the costs of a clinical trial that would otherwise have been incurred in full.
Our participation in the DEVOTE programme is well underway and is generating additional performance data in an acute care setting. This expanded dataset is required to drive our CE-IVD submission, which will allow for subsequent commercialisation in the EU. Submission is achievable in the second half of 2024 once genedrive's engagement with DEVOTE has completed. With an approximate seven-month regulatory review process, we anticipate CE-IVD certification in early 2025. Whilst already UKCA marked, our commercialisation efforts in the UK will commence following successful completion of the DEVOTE clinical performance study at end of May 2024.
In the UK, the Company will be selling the product through its direct sales team, and momentum for adoption is expected to be influenced by positive final NICE recommendations for CYP2C19 testing. The draft NICE guidance recommends CYP2C19 genotyping for clopidogrel treatment and Genedrive® CYP2C19 ID test modelled to be a clinically and most dominant cost-effective option. The second consultation on the draft guidance is scheduled to commence on 3 April 2024 and the final NICE recommendations are expected to be published in July 2024.
Antiplatelet therapies such as Clopidogrel are recommended by NICE to prevent occlusive vascular events for people who have had an ischaemic stroke, who have peripheral arterial disease or multivesicular disease, or for people who have had a myocardial infarction only if aspirin is contraindicated or not tolerated. Other antiplatelet drugs can be used where clopidogrel is contraindicated or not tolerated. Other antiplatelet therapies have a higher risk of bleeding, although equivalent efficiency if preceded by CYP2C19 genotype guided therapy, and so in ischaemic stroke, current draft guidance from NICE states that CYP2C19 genotyping should be conducted in advance of Clopidogrel administration within 24 hours for ischaemic stroke. It is likely that this pathway will be adopted for other indications requiring clopidogrel, for example, in cardiovascular indications.
RESULTADOS FINANCIEROS
Revenue and other income in the period was 0.24m (H1 2022/3: 0.02m).
Research and development costs continued at similar levels, being £1.9m (H1 2022/3: £2.0m) as the Company focused on near-commercialisation product development. Administration costs continue to be controlled at £721k (H1 2022/3: £713k). The trading loss for the period was £2.4m (H1 2022/3: £2.7m). Finance costs in the period of £30k (H1 2022/3: £11k).
After financing costs, the loss before taxation was £2.4m (H1 2022/3: £2.7m loss before taxations). The loss after taxation decreases to £2.0m (H1 2022/3: £2.2m loss after taxation) after estimating the six-month taxation credit as £0.35m (H1 2022/3: £0.5m). The basic loss per share was 2.0p (H1 2022/3: 2.4p basic loss per share).
Recursos en efectivo
The operating loss for the period was £2.4m (H1 2022/3: £2.7m) and working capital reduced by £0.2m (H1 2022/3: £0.1m). Net cash out-flow from operations was £2.4m (H1 2022.3: £2.4m) and as the R&D tax credit was not received in the period the net cash flow from operating activities was also £2.4m.
Cash flows from financing activities consisted of lease liability repayments of £112k (H1 2022/3: £81k) and there was £1.2m of proceeds from the Investor Placing Agreement (H1 2022/3: £nil).
Closing cash was £1.2m (31 December 2022: £2.21m). The cash balance on 21 March 2024 was £1.2m with £0.8m received from the R&D tax credit post period end; the current burn rate without any material revenues and assuming current levels of expenditure is circa £0.4m per month.
Balance
Balance sheet net assets at 31 December 2023 were £1.5m (30 June 2023: £2m; 31 December 2022: £3.5m) and the consolidated loss of the period was £2m (H1 2022/3: £2.2m). As at 31 December 2023 the amount outstanding from the investor placing agreement was £1m (30 Junio 2023: £1.3m) and £0.1m on 21 March 2024.
PRINCIPALES RIESGOS E INCERTIDUMBRES
Hay una serie de riesgos e incertidumbres potenciales que podrían tener un impacto material en el desempeño de la Compañía durante los seis meses restantes del año fiscal y podrían causar que los resultados reales difieran materialmente de los resultados esperados e históricos. Los Directores no consideran que estos principales riesgos e incertidumbres hayan cambiado sustancialmente desde la publicación del informe anual para el año que finalizó el 30 de junio de 2023; una explicación más detallada de los riesgos para la Compañía se encuentra en la página 20 del informe anual.
Preocupación continua
At the current burn rate, the Company has a cash runway through May 2024. We are confident that we will continue to gain commercial traction and securing significant revenues, but due to the time required to achieve this, as we have already stated, we will require additional funding. As described in the accounting policies, we continue to adopt a going concern basis for the preparation of the accounts, but the above condition represents a material uncertainty that may cast significant doubt on the Group and Company's ability to continue as a going concern. As set out above, the Company is actively pursuing further equity funding to provide the necessary resources to execute the Company's growth strategy.
PANORAMA
The Board is pleased with the tangible progress the Group is generating, with a clear focus on pharmacogenetic testing and the commercialisation of our two innovative products. This fuels the Board's optimism for future success, as we strive to generate value for our shareholders while positively impacting individuals' lives.
The news that funding is to be made available from the government's Office for Life Sciences via NIHR for the real world evidence generation required by NICE for our Genedrive® MT-RNR1 ID Kit is very welcome, affording the potential for it to move from a conditional recommendation to a full recommendation with NICE which would accelerate the adoption of the test in the NHS. Genedrive is a technical partner in an application from a consortia of 14 hospitals throughout the UK regions, led by our clinical partners at MFT.
Our equity funding plans are being advanced and the intention will be to raise sufficient funding to complete the clinical trials and regulatory approval process in the USA for the AIHL test whilst also providing sufficient funding to cover the Company's operating costs for an appropriate period of time. The Board intends to provide a mechanism for retail shareholders to participate in any equity financing and a further announcement will be made in due course.
Securing further funding is key to the execution of our strategy as is finalising our partnership in the USA for MT-RNR1 studies required for future novo submission route for FDA approval. As a direct result of our collaboration with clinical colleagues under the DEVOTE programme for CYP2C19, we should also achieve IVDR approval for CYP2C19 by the end of 2024/early 2025 allowing us to sell the product into Europe and further afield. With both these products, with strong unmet need, clear market potential and defined NICE recommendations, genedrive has significant potential but we will also pursue new developments, partnerships and opportunities for Pharmacogenetic testing. We believe we are in the right place at the right time, with the right products, with little competition in the field of point of care pharmacogenetic testing.
james la mejilla
Director Ejecutivo
Dr. Ian Gilham
Presidente
28 de marzo de 2024
ESTADO DE RESULTADOS INTEGRALES CONSOLIDADOS NO AUDITADOS
Por los seis meses terminados el 31 de diciembre de 2023
Seis meses terminaron | Seis meses terminaron | Año terminado | ||
31 de diciembre 2023
| 31 de diciembre 2022
| 30 de junio de 2023 | ||
Sin auditar | Sin auditar | auditado
| ||
Note | £000 | £000 | £000 | |
Ingresos y otros ingresos | (4) | 238 | 21 | 55 |
Costos de investigación y desarrollo. | (1,876) | (1,988) | (3,924) | |
Costes administrativos | (721) | (713) | (1,355) | |
Pérdida operativa | (4) | (2,359) | (2,680) | (5,224) |
Costos financieros | (5) | (30) | (11) | (757) |
Pérdida de actividades ordinarias antes de impuestos | (2,389) | (2,691) | (5,981) | |
Taxation | 350 | 500 | 831 | |
Pérdida del ejercicio económico | (2,039) | (2,191) | (5,150) | |
Gasto integral total del período | (2,039) | (2,191) | (5,150) | |
Pérdida por acción (peniques) | ||||
-Básico | (2.0) p | (2.4) p | (5.5) p | |
-Diluido | (2.0) p | (2.4) p | (5.5) p | |
ESTADO DE CAMBIOS EN PATRIMONIO NETO CONSOLIDADO NO AUDITADO
Por los seis meses terminados el 31 de diciembre de 2023
Capital social (No auditado) £000 | Otras reservas (No auditado) £000 | Acumulado Pérdidas (No auditado) £000 | Total (No auditado) £000 | |
Al 30 de junio de 2022 | 1,388 | 51,294 | (47,071) | 5,611 |
Pagos basados en acciones liquidados con capital | - | 34 | - | 34 |
Transacciones liquidadas directamente en patrimonio | - | 34 | - | 34 |
Pérdida integral total del período | - | - | (2,191) | (2,191) |
Al 31 de diciembre de 2022 | 1,388 | 51,328 | (49,262) | 3,454 |
Compartir asunto | - | 2 | - | 2 |
Investment funding arrangement, net of costs | 97 | 1,385 | - | 1,482 |
Pagos basados en acciones liquidados con capital | - | 62 | - | 62 |
Transacciones liquidadas directamente en patrimonio | 97 | 1,449 | - | 1,546 |
Pérdida integral total del período | - | - | (2,959) | (2,959) |
Al 30 de junio de 2023 | 1,485 | 52,777 | (52,221) | 2,041 |
Investment funding arrangement, net of costs | 351 | 1,113 | - | 1,464 |
Pagos basados en acciones liquidados con capital | - | 40 | - | 40 |
Transacciones liquidadas directamente en patrimonio | 351 | 1,153 | - | 1,504 |
Pérdida integral total del período | - | - | (2,039) | (2,039) |
Al 31 de diciembre de 2023 | 1,836 | 53,930 | (54,260) | 1,506 |
BALANCE DE SITUACIÓN CONSOLIDADO NO AUDITADO
Al 31 de diciembre de 2023
31 diciembre | 31 diciembre | 30 junio | |
2023 | 2022 | 2023 | |
(No auditado) | (No auditado) | (auditado) | |
Note | £000 | £000 | £000 |
Activos no corrientes | |||
Activos intangibles | - | - | - |
Planta y equipo | 279 | 503 | 392 |
279 | 503 | 392 | |
Activos circulantes | |||
Los inventarios | 539 | 665 | 525 |
Cuentas comerciales y otras cuentas por cobrar | 214 | 126 | 158 |
Activo por impuesto corriente (6) | 1,181 | 1,456 | 831 |
Efectivo y equivalentes de efectivo | 1,226 | 2,083 | 2,601 |
3,160 | 4,330 | 4,115 | |
Pasivos | |||
Pasivo circulante | |||
Comerciales y otras cuentas a pagar | (788) | (1,066) | (935) |
Pasivos por arrendamiento | (129) | (221) | (222) |
Instrumentos financieros derivados | (1,016) | - | (1,290) |
(1,933) | (1,287) | (2,447) | |
Pasivos no corrientes | |||
Pasivos por arrendamiento | - | (92) | (19) |
Pasivos totales | (1,933)
| (92) | (2,466) |
Activos netos | 1,506 | 3,454 | 2,041 |
Capital y reservas | |||
Capital social exigido (8) | 1,836 | 1,388 | 1,485 |
Otras reservas (9) | 53,930 | 51,328 | 52,777 |
Perdidas acumuladas | (54,260) | (49,262) | (52,221) |
Capital social total | 1,506 | 3,454 | 2,041 |
ESTADO DE FLUJOS DE EFECTIVO CONSOLIDADO NO AUDITADO
Por los seis meses terminados el 31 de diciembre de 2023
31 de diciembre 2023 (No auditado) | 31 de diciembre 2022 (No auditado) | 30 junio 2023 (auditado) | |
000 £ | 000 £ | 000 £ | |
flujos de efectivo por actividades operacionales | |||
Pérdida operativa del período | (2,359) | (2,680) | (5,224) |
Depreciación y amortización de activos no arrendados | 28 | 32 | 61 |
Depreciación de activos por derecho de uso | 90 | 81 | 193 |
Pagos basados en acciones | 40 | 34 | 96 |
Pérdida operativa antes de cambios en el capital de trabajo y provisiones | (2,201) | (2,533) | (4,874) |
Increase/ (decrease) in inventories | (14) | 83 | 223 |
(Aumento) / disminución de cuentas por cobrar comerciales y otras | (56) | (19) | (51) |
Decrease/ (increase) in trade and other payables | (147) | 62 | (59) |
Salida neta de efectivo de las operaciones | (2,418) | (2,407) | (4,761) |
Impuesto recibido | - | - | 956 |
Salida neta de efectivo de las actividades operativas | (2,418) | (2,407) | (3,805) |
Flujos de efectivo de actividades de inversión | |||
Ingresos financieros | 18 | 5 | 29 |
Costos financieros | (10) | (16) | - |
Ingresos por enajenación de operaciones discontinuadas | - | 14 | 15 |
Adquisición de planta y equipo y activos intangibles | (5) | (21) | (52) |
Net cash inflow/ (outflow) from investing activities | 3 | (18) | (8) |
Flujos de efectivo de actividades de financiación | |||
Proceeds from the investment placing agreement | 1,200 | - | 2,300 |
Transaction costs relating to investment placing agreement | (48) | (283) | |
Reembolso de los pasivos por arrendamiento | (112) | (81) | (193) |
Net inflow/ (outflow) from financing activities | 1,040 | (81) | 1,824 |
Disminución neta de equivalentes de efectivo | (1,375) | (2,506) | (1,989) |
Efectos de los cambios en el tipo de cambio en efectivo y equivalentes de efectivo | - | - | 1 |
Efectivo y equivalentes de efectivo al comienzo del período | 2,601 | 4,589 | 4,589 |
Efectivo y equivalentes de efectivo al final del período | 1,226 | 2,083 | 2,601 |
Análisis de fondos netos | |||
Efectivo en banco y en mano | 1,226 | 2,083 | 2,601 |
NOTAS A LOS ESTADOS FINANCIEROS INTERMEDIOS NO AUDITADOS
1. Información general
genedrive plc ('the Company') and its subsidiaries (together 'the Group') is a pharmacogenetic testing company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need pharmacogenetic platform for the diagnosis of genetic variations. The Company is a limited liability company incorporated and domiciled in the UK. The address of its registered office is 48 Grafton Street, Manchester, M13 9XX. The Company has its listing on AIM.
La información financiera del período finalizado el 31 de diciembre de 2023 y, de manera similar, el período finalizado el 31 de diciembre de 2022 no ha sido auditada ni revisada por el auditor. La información financiera para el año terminado el 30 de junio de 2023 se ha basado en la información de los estados financieros auditados para ese período. Los estados financieros intermedios para el período finalizado el 31 de diciembre de 2023 no constituyen cuentas legales según se define en la sección 434 de la Ley de Sociedades de 2006. Se ha entregado una copia de las cuentas legales para el año finalizado el 30 de junio de 2023 al Registrador de Empresas, el Las cuentas tenían una opinión de auditoría sin salvedades y no contenían una declaración en virtud de la sección 498(2) o (3) de la Ley de Sociedades de 2006, pero incluían una referencia a una incertidumbre material que podría generar dudas significativas sobre la capacidad del Grupo para continuar como empresa en marcha. preocupación, sobre la que el auditor llamó la atención a modo de énfasis.
Estos estados financieros intermedios fueron aprobados por el Consejo de Administración el 28 de marzo de 2024.
Las políticas contables que se establecen a continuación, a menos que se indique lo contrario, se han aplicado uniformemente a todos los períodos representados en estos estados financieros consolidados.
2. Políticas contables importantes
Bases de contabilidad
Los estados financieros intermedios consolidados consolidan los de la Compañía y sus subsidiarias (en conjunto, el "Grupo"). Se presentan en libras esterlinas y todos los valores se redondean a las mil libras (£k) más próximas, salvo que se indique lo contrario.
Las subsidiarias son entidades controladas por el Grupo. Los estados financieros de las subsidiarias se incluyen en los estados financieros consolidados desde la fecha en que comienza el control hasta la fecha en que cesa el control. Las transacciones entre empresas del Grupo se eliminan en la consolidación.
Las políticas contables utilizadas en la preparación de la información financiera para el semestre terminado el 31 de diciembre de 2023 están de acuerdo con los criterios de reconocimiento y medición de las normas contables internacionales adoptadas en el Reino Unido y son consistentes con las que se adoptarán en los estados financieros anuales para el año que finaliza el 30 de junio de 2024. Si bien la información financiera incluida ha sido preparada de acuerdo con los criterios de reconocimiento y medición de las normas contables internacionales, la información financiera no contiene información suficiente para cumplir con las normas contables internacionales. El Grupo no ha aplicado la NIC 34, Información financiera intermedia, que no es obligatoria para los grupos que cotizan en AIM del Reino Unido, en la preparación de este informe financiero intermedio.
Preocupación continua
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 the near term 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 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 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.
While the Board has a successful track record in raising funds, there remains uncertainty as to the amount of funding that could be raised from shareholders or debt providers. The combination of the above factors represents a material uncertainty that may cast significant doubt on the Group and Company's ability to continue as a going concern.
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.
Nuevas normas contables adoptadas en el período
No se han adoptado nuevas normas contables en el período que hayan tenido un impacto significativo en los estados financieros.
Estimaciones
La preparación de estados financieros intermedios requiere que la administración haga juicios, estimaciones y supuestos que afectan la aplicación de las políticas contables y los montos reportados de activos y pasivos, ingresos y gastos. Los resultados reales pueden diferir de estas estimaciones.
En la preparación de estos estados financieros intermedios, los juicios significativos realizados por la administración al aplicar las políticas contables del Grupo y las fuentes clave de estimación fueron los mismos que se aplicaron a los estados financieros consolidados para el año terminado el 30 de junio de 2023, con la excepción de cambios en estimaciones que se requieren en:
- determinar la provisión para impuestos; y
- determinar el valor en libros del inventario
Reconocimiento de ingresos
a. Venta de productos
Las ventas de bienes se reconocen cuando se han cumplido todas las obligaciones de desempeño y cuando la entidad del Grupo no tiene una participación gerencial continua ni un control efectivo sobre los bienes. La transferencia de control de los bienes puede pasar en varios puntos dependiendo de los términos de envío del contrato con el cliente, pueden ser en el momento de la recogida en las instalaciones o la entrega en el puerto correspondiente o en las instalaciones designadas por el cliente. Cuando los artículos se venden con derecho a devolución, la experiencia acumulada se utiliza para estimar y prever dichas devoluciones en el momento de la venta.
b. Ingresos por licencias y colaboración
Los pagos por adelantado acordados contractualmente y los pagos no reembolsables similares con respecto a los acuerdos de colaboración o licencia que no están directamente relacionados con la actividad de investigación en curso se registran como ingresos diferidos y se reconocen como ingresos durante la duración prevista del acuerdo. Cuando se modifica la duración prevista del acuerdo, también se modifica el período durante el cual se reconocen los ingresos.
Los hitos no reembolsables y otros pagos que están vinculados al logro de obstáculos tecnológicos o normativos significativos y sustantivos en el proceso de investigación y desarrollo se reconocen como ingresos al alcanzar los hitos especificados.
Los ingresos que están relacionados con la actividad de investigación en curso se reconocen a medida que se lleva a cabo la actividad de investigación, de acuerdo con el contrato. La actividad se mide en función del progreso y los hitos y no del costo.
C. Otros ingresos: financiación de subvenciones para el desarrollo
Los ingresos por cobrar en forma de subvenciones gubernamentales para financiar el desarrollo de productos se reconocen como financiación de subvenciones para el desarrollo durante los períodos en los que el Grupo reconoce, como gastos, los costos elegibles relacionados que las subvenciones pretenden compensar y cuando existe una seguridad razonable de que el Grupo cumplirá con las condiciones a ellas vinculadas y que se percibirán los ingresos. Las subvenciones del gobierno cuya condición principal es que el Grupo compre o adquiera activos no corrientes se reconocen como ingresos diferidos en el Balance de Situación Consolidado y se transfieren al Estado de Resultados Integrales Consolidado de forma sistemática y racional durante la vida útil de los correspondientes. activos.
Investigación y desarrollo
Los gastos de investigación se amortizan a medida que se incurren. Los gastos de desarrollo se amortizan a medida que se incurren hasta el punto de validación técnica y comercial. Posteriormente, los costos que son medibles y atribuibles al proyecto se transfieren como activos intangibles, sujeto a haber cumplido con los siguientes criterios:
· demostración de que el producto generará beneficios económicos futuros rentables y de la intención y capacidad de vender el producto;
· evaluación de la viabilidad técnica;
· confirmación de la disponibilidad de recursos técnicos, financieros y otros para completar el desarrollo;
· la gerencia tiene la intención de completar el desarrollo para que el producto esté disponible para su uso; y
· el gasto atribuible al desarrollo puede medirse de forma fiable.
Activos por derecho de uso (ROU)
At inception of a contract, the Group assesses whether a contract is, or contains, a lease. A contract is, or contains, a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases are recognised as an ROU asset and a corresponding lease liability at the date at which the leased asset is available for use by the Group. At the lease commencement date, a ROU asset is measured at cost comprising the following: the amount of the initial measurement of the lease liability; any lease payments made at or before the commencement date less any lease incentives received; any initial direct costs; and restoration costs to return the asset to its original condition. The ROU asset is depreciated over the shorter of the asset's useful life and the lease term on a straight-line basis. If ownership of the ROU asset transfers to the Group at the end of the lease term or the cost reflects the exercise of a purchase option, depreciation is calculated using the estimated useful life of the asset.
Monedas extranjeras
(a) Moneda funcional y de presentación
Las partidas incluidas en los estados financieros de cada una de las entidades del Grupo se valoran utilizando la moneda del entorno económico principal en el que opera la entidad ('moneda funcional'). Los estados financieros consolidados se presentan en libras esterlinas, que es la moneda de presentación del Grupo.
(b) Transacciones y saldos
Las transacciones en moneda extranjera se convierten a la moneda funcional utilizando los tipos de cambio vigentes en las fechas de las transacciones. Las ganancias y pérdidas cambiarias resultantes de la liquidación de dichas transacciones y de la conversión al final del año de los tipos de cambio de los activos y pasivos monetarios denominados en moneda extranjera se reconocen en el estado de resultados, excepto cuando se difieren en el patrimonio como coberturas de inversión neta calificada. Las partidas no monetarias valoradas a valor razonable y denominadas en moneda extranjera se reconvierten a los tipos de cambio vigentes en la fecha en que se determina el valor razonable.
3. Ingresos
Los ingresos se miden al valor razonable de la contraprestación recibida o por recibir y neto de descuentos e impuestos relacionados con las ventas.
4. Segmentos operativos
Segmento de diagnóstico | Administrativo Precio | Total | |||
Seis meses finalizados el 31 de diciembre de 2023 | 000 £ | 000 £ | 000 £ | ||
Ingresos y otros ingresos | 238 | - | 238 | ||
Pérdida operativa | (1,638) | (721) | (2,359) | ||
Costos financieros netos | (30) | ||||
Pérdida de actividades ordinarias antes de impuestos | (2,389) | ||||
Taxation Pérdida para la financiera | 350 | ||||
Pérdida del ejercicio económico | (2,039) | ||||
| |||||
| Segmento de diagnóstico | Administrativo Precio | Total | ||
Seis meses finalizados el 31 de diciembre de 2022 | 000 £ | 000 £ | 000 £ | ||
Ingresos y otros ingresos | 21 | - | 21 | ||
Pérdida operativa | (1,967) | (713) | (2,680) | ||
Costos financieros netos | (11) | ||||
Pérdida de actividades ordinarias antes de impuestos | (2,691) | ||||
Taxation Pérdida para la financiera | 500 | ||||
Pérdida del ejercicio económico | (2,191) | ||||
| |||||
Segmento de diagnóstico | Administrativo Precio | Total | |||
Doce meses terminados el 30 de junio de 2023 | 000 £ | 000 £ | 000 £ | ||
Ingresos y otros 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 Pérdida para la financiera | 831 | ||||
Pérdida del ejercicio económico | (5,150) |
5. Gastos financieros netos
31 diciembre diciembre | 31 diciembre diciembre | 30 junio | |
2023 | 2022 | 2023 | |
£000 | £000 | £000 | |
Ingresos netos por intereses de depósitos bancarios | 18 | 5 | 30 |
Transaction costs relating to investment placing agreement | (40) | - | (81) |
Movement in fair value of derivative financial instrument | - | - | (675) |
Costos de intereses de arrendamiento financiero | (8) | (16) | (31) |
(30) | (11) | (757) |
6. Activo por impuesto corriente
The current tax asset relates to tax owing under the R&D tax credit scheme of £1.2m (H1 2022/3: £1.5m). A payment of £0.8m was received in March 2024. The remaining £0.4m is an estimate of the tax credit for the interim period to December 2023 and this will be received following submission of the tax returns for the 12 months to June 2024, with receipt expected to be in the first quarter of 2025.
7. Beneficio por acción
The basic earnings per share is calculated by dividing the earnings attributable to ordinary shareholders for the year by the weighted average number of ordinary shares in issue during the period. The weighted average number of shares in issue during the period was 103,900,492 (H1 2022/3: 92,542,446). Potentially dilutive options, after proceeds from conversion, add no shares to basic weighted average number of shares in issue (H1 2022/3: 40,342).
8. Compartir capital
Asignado, emitido y pagado en su totalidad: | No |
000 £ | |
Saldo al 30 de junio de 2022 y al 31 de diciembre 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 | |
Compartir asunto | 23,390,000 | 351 | |
Saldo al 31 de diciembre de 2023 | 122,439,946 | 1,836 | |
During the financial period the Company issued 23,390,000 shares in genedrive plc as part of the Investor Placing Agreement entered into on 31 March 2023.
9. Otras Reservas
Cuenta Premium Share £000 | Acciones a emitir £000 | Reserva del plan de incentivos de acciones para empleados £000 | Reserva de opciones sobre acciones £000 | Reserva de adquisiciones inversas £000 | Total £000 | |||||
Al 30 de junio de 2022 | 52,426 | - | (196) | 1,560 | (2,496) | 51,294 | ||||
Pagos basados en acciones liquidados mediante acciones | - | - | - | 34 | - | 34 | ||||
Al 31 de diciembre de 2022 | 52,426 | - | (196) | 1,594 | (2,496) | 51,328 | ||||
Acuerdo de financiación de inversiones | 910 | 477 | - | - | - | 1,387 | ||||
Compartir asunto | - | - | - | - | - | - | ||||
Pagos basados en acciones liquidados mediante acciones | - | - | - | 62 | - | 62 | ||||
Al 30 de junio de 2023 | 53,336 | 477 | (196) | 1,656 | (2,496) | 52,777 | ||||
Acuerdo de financiación de inversiones | 916 | 197 | - | - | - | 1,113 | ||||
Compartir asunto | - | - | - | - | - | - | ||||
Pagos basados en acciones liquidados mediante acciones | - | - | - | 40 | - | 40 | ||||
Al 31 de diciembre de 2023 | 54,252 | 674 | (196) | 1,696 | (2,496) | 53,390 | ||||
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