반기 보고서
유전자 드라이브 PLC
("genedrive" 또는 "회사")
31년 2023월 XNUMX일까지의 중간 결과
genedrive plc (LSE: GDR), the point of care pharmacogenetic testing company, announces unaudited interim results for the six months to 31 December 2023.
운영 하이라이트(포스트 기간 포함)
· Food and Drug Administration ("FDA") progress for the 진드라이브® 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 진드라이브® 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 The second consultation on the draft guidance is scheduled to commence on 3 April 2024 and the final NICE recommendations are expected to be published in July 2024
재무 하이라이트
· 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 진드라이브® 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."
유전자 드라이브 PLC | +44 (0)161 989 0245 |
제임스 뺨: CEO / 러스 쇼: CFO | |
Peel Hunt LLP(지명 고문 및 Broker) | +44 (0)20 7418 8900 |
제임스 스틸 / 패트릭 버크홀름 | |
Walbrook PR Ltd(미디어 및 투자자 관계) | +44 (0)20 7933 8780 또는 [이메일 보호] |
안나 던피 | +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.
회사는 시장 내 판매 극대화, 지리적 및 포트폴리오 확장, 전략적 M&A를 통해 성장을 가속화하는 데 초점을 맞춘 명확한 상업 전략을 갖고 있으며 맨체스터에 있는 시설에서 운영됩니다.
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.
항생제 유도 청력 손실(AIHL) - Genedrive® MT-RNR1-ID 키트
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.
진드라이브® 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.
재무 결과
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).
현금 자원
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.
대차 대조표
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 June 2023 : £1.3m) and £0.1m on 21 March 2024.
주요 위험 및 불확실성
회계연도의 남은 30개월 동안 회사의 성과에 중대한 영향을 미칠 수 있고 실제 결과가 예상 및 과거 결과와 크게 다를 수 있는 잠재적인 위험과 불확실성이 많이 있습니다. 이사들은 이러한 주요 위험과 불확실성이 2023년 20월 XNUMX일 마감 연차 보고서 발행 이후 실질적으로 변경되었다고 생각하지 않습니다. 회사의 위험에 대한 자세한 설명은 연례 보고서의 XNUMX페이지에서 확인할 수 있습니다.
관심가는
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.
시야
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 드 노보 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.
제임스 치크
최고 경영자(CEO)
이안 길햄 박사
의장
월 28 2024
포괄손익계산서 미감사 연결 재무제표
31년 2023월 XNUMX일로 종료되는 XNUMX개월 동안
XNUMX 개월은 끝났다 | XNUMX 개월은 끝났다 | 연말 | ||
31 12월 2023
| 31 12월 2022
| 30 6월 2023 | ||
감사되지 않음 | 감사되지 않음 | 감사
| ||
주의 사항 | £000 | £000 | £000 | |
수익 및 기타 소득 | (4) | 238 | 21 | 55 |
연구 및 개발 비용 | (1,876) | (1,988) | (3,924) | |
관리 비용 | (721) | (713) | (1,355) | |
운영 손실 | (4) | (2,359) | (2,680) | (5,224) |
금융 비용 | (5) | (30) | (11) | (757) |
과세 전 일반 활동 손실 | (2,389) | (2,691) | (5,981) | |
과세 | 350 | 500 | 831 | |
재무 기간 동안의 손실 | (2,039) | (2,191) | (5,150) | |
해당 기간의 총포괄비용 | (2,039) | (2,191) | (5,150) | |
주당 손실(펜스) | ||||
-기본 | (2.0:XNUMX)p | (2.4:XNUMX)p | (5.5:XNUMX)p | |
-희석 | (2.0:XNUMX)p | (2.4:XNUMX)p | (5.5:XNUMX)p | |
자본 변동에 대한 감사되지 않은 연결 재무제표
31년 2023월 XNUMX일로 종료되는 XNUMX개월 동안
주식 자본 (감사하지 않음) £000 | 기타 준비금 (감사하지 않음) £000 | 누적 된 손실 (감사하지 않음) £000 | 금액 (감사하지 않음) £000 | |
30년 2022월 XNUMX일 | 1,388 | 51,294 | (47,071) | 5,611 |
주식결제형 주식기준보상 | - | 34 | - | 34 |
지분으로 직접 결제되는 거래 | - | 34 | - | 34 |
해당 기간의 총포괄손실 | - | - | (2,191) | (2,191) |
31년 2022월 XNUMX일 | 1,388 | 51,328 | (49,262) | 3,454 |
이슈 공유 | - | 2 | - | 2 |
Investment funding arrangement, net of costs | 97 | 1,385 | - | 1,482 |
주식결제형 주식기준보상 | - | 62 | - | 62 |
지분으로 직접 결제되는 거래 | 97 | 1,449 | - | 1,546 |
해당 기간의 총포괄손실 | - | - | (2,959) | (2,959) |
30년 2023월 XNUMX일 | 1,485 | 52,777 | (52,221) | 2,041 |
Investment funding arrangement, net of costs | 351 | 1,113 | - | 1,464 |
주식결제형 주식기준보상 | - | 40 | - | 40 |
지분으로 직접 결제되는 거래 | 351 | 1,153 | - | 1,504 |
해당 기간의 총포괄손실 | - | - | (2,039) | (2,039) |
31년 2023월 XNUMX일 | 1,836 | 53,930 | (54,260) | 1,506 |
미감사 연결 대차대조표
31 년 2023 월 XNUMX 일 기준
31 12월 | 31 12월 | 6월 30 | |
2023 | 2022 | 2023 | |
(감사하지 않음) | (감사하지 않음) | (감사) | |
주의 사항 | £000 | £000 | £000 |
비유동 자산 | |||
무형 자산 | - | - | - |
공장 및 장비 | 279 | 503 | 392 |
279 | 503 | 392 | |
유동 자산 | |||
재고 | 539 | 665 | 525 |
매출 채권 및 기타 채권 | 214 | 126 | 158 |
당기법인세자산 (6) | 1,181 | 1,456 | 831 |
현금 및 현금성 자산 | 1,226 | 2,083 | 2,601 |
3,160 | 4,330 | 4,115 | |
부채 | |||
유동 부채 | |||
매입 채무 및 기타 채무 | (788) | (1,066) | (935) |
리스 부채 | (129) | (221) | (222) |
파생 금융 상품 | (1,016) | - | (1,290) |
(1,933) | (1,287) | (2,447) | |
비유동 부채 | |||
리스 부채 | - | (92) | (19) |
총 부채 | (1,933)
| (92) | (2,466) |
순자산 | 1,506 | 3,454 | 2,041 |
자본 및 준비금 | |||
자기자본상환(8) | 1,836 | 1,388 | 1,485 |
기타 매장량 (9) | 53,930 | 51,328 | 52,777 |
누적 손실 | (54,260) | (49,262) | (52,221) |
총 주주 자본 | 1,506 | 3,454 | 2,041 |
감사되지 않은 연결 현금 흐름 명세서
31년 2023월 XNUMX일로 종료되는 XNUMX개월 동안
31 12월 2023 (감사하지 않음) | 31 12월 2022 (감사하지 않음) | 6월 30 2023 (감사) | |
£'000 | £'000 | £'000 | |
영업 활동으로 인한 현금 흐름 | |||
해당기간 영업손실 | (2,359) | (2,680) | (5,224) |
비리스 자산의 감가 상각 | 28 | 32 | 61 |
사용권 자산의 감가상각 | 90 | 81 | 193 |
공유 기준 지불 | 40 | 34 | 96 |
운전자본 및 충당부채 변경 전 영업손실 | (2,201) | (2,533) | (4,874) |
Increase/ (decrease) in inventories | (14) | 83 | 223 |
매출채권 및 기타수취채권의 (증가)/감소 | (56) | (19) | (51) |
Decrease/ (increase) in trade and other payables | (147) | 62 | (59) |
영업 순 현금 유출 | (2,418) | (2,407) | (4,761) |
받은 세금 | - | - | 956 |
영업활동으로 인한 순현금유출 | (2,418) | (2,407) | (3,805) |
투자 활동으로 인한 현금 흐름 | |||
금융 수입 | 18 | 5 | 29 |
금융 비용 | (10) | (16) | - |
중단영업 처분으로 인한 이익 | - | 14 | 15 |
플랜트 및 장비 및 무형 자산의 취득 | (5) | (21) | (52) |
투자 활동으로 인한 순현금 유입/(유출) | 3 | (18) | (8) |
금융 활동으로 인한 현금 흐름 | |||
Proceeds from the investment placing agreement | 1,200 | - | 2,300 |
Transaction costs relating to investment placing agreement | (48) | (283) | |
리스 부채 상환 | (112) | (81) | (193) |
Net inflow/ (outflow) from financing activities | 1,040 | (81) | 1,824 |
현금성자산의 순감소 | (1,375) | (2,506) | (1,989) |
현금 및 현금성 자산에 대한 환율 변화의 영향 | - | - | 1 |
기간 초기 현금 및 현금성 자산 | 2,601 | 4,589 | 4,589 |
기말의 현금 및 현금성 자산 | 1,226 | 2,083 | 2,601 |
순자금 분석 | |||
은행 및 수중에 현금 | 1,226 | 2,083 | 2,601 |
감사를 받지 않은 중간재무제표에 대한 주석
1. 일반 정보
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.
31년 2023월 31일 종료된 기간 및 마찬가지로 2022년 30월 2023일 종료된 기간의 재무 정보는 감사인이 감사하거나 검토하지 않았습니다. 31년 2023월 434일에 종료되는 연도의 재무 정보는 해당 기간 동안 감사된 재무제표의 정보를 기반으로 합니다. 2006년 30월 2023일 종료된 기간의 중간 재무제표는 498년 회사법 2조에 정의된 법정 계정을 구성하지 않습니다. 3년 2006월 XNUMX일 종료된 연도의 법정 계정 사본이 회사 등록관인 계정에 부적격한 감사 의견이 있고 XNUMX년 회사법 XNUMX(XNUMX) 또는 (XNUMX)조에 따른 진술이 포함되지 않았지만 계속해서 그룹의 지속 능력에 상당한 의문을 제기할 수 있는 중요한 불확실성에 대한 언급이 포함되었습니다. 감사인이 강조하여 주의를 환기시킨 우려 사항.
이 중간재무제표는 28년 2024월 XNUMX일 이사회에서 승인되었습니다.
아래에 제시된 회계정책은 별도의 언급이 없는 한 이 연결재무제표의 모든 기간에 일관되게 적용되었습니다.
2. 중요한 회계정책
회계의 기초
연결 중간재무제표는 당사와 그 종속기업(이하 "연결회사"라 함)의 연결재무제표를 연결한 것입니다. 그들은 파운드화로 표시되며 모든 값은 달리 표시된 경우를 제외하고 가장 가까운 XNUMX파운드(£k) 단위로 반올림됩니다.
자회사는 그룹이 지배하는 기업입니다. 종속기업의 재무제표는 통제가 시작된 날부터 통제가 중단된 날까지 연결재무제표에 포함됩니다. 그룹 회사 간의 거래는 연결 시 제거됩니다.
31년 2023월 30일로 종료되는 2024개월 동안의 재무 정보 작성에 사용된 회계 정책은 영국이 채택한 국제 회계 기준의 인식 및 측정 기준을 따르며, 연간 재무제표에서 채택될 회계 정책과 일치합니다. 포함된 재무정보는 국제회계기준의 인식 및 측정기준에 따라 작성되었으나 국제회계기준을 준수하기에는 충분한 정보가 포함되어 있지 않습니다. 연결실체는 본 중간재무보고서 작성 시 영국 AIM 상장 그룹의 의무사항이 아닌 IAS 34, 중간재무보고를 적용하지 않았습니다.
관심가는
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.
Accordingly, the Directors have concluded that it is appropriate to continue to adopt the going concern basis of accounting in preparing these financial statements. These financial statements do not include the adjustments that would result if the Group and Company were unable to continue as a going concern.
해당 기간에 채택된 새로운 회계 기준
당기 중 재무제표에 중대한 영향을 미친 새로운 회계기준은 없습니다.
견적
중간재무제표를 작성하려면 경영진이 회계정책의 적용과 보고된 자산과 부채, 수익과 비용의 금액에 영향을 미치는 판단, 추정 및 가정을 해야 합니다. 실제 결과는 이러한 추정치와 다를 수 있습니다.
중간재무제표를 작성함에 있어 연결실체의 회계정책을 적용함에 있어서 경영진이 내린 유의적 판단과 주요 추정자료는 변경된 사항을 제외하고는 30년 2023월 XNUMX일로 종료하는 회계연도의 연결재무제표에 적용된 것과 동일합니다. 다음에서 필요한 견적:
- 과세 조항 결정 그리고
- 재고자산의 장부가액 결정
수익 인식
ㅏ. 제품 판매
재화의 판매는 모든 수행의무가 완료되고 연결기업이 재화에 대한 지속적인 관리 관여나 효과적인 통제가 없을 때 인식됩니다. 상품 관리 이전은 고객과의 계약 운송 조건에 따라 다양한 지점에서 이루어질 수 있으며, 구내에서 수거하거나 관련 항구 또는 고객이 지정한 구내로 배송될 수 있습니다. 품목이 반품 권리와 함께 판매되는 경우 축적된 경험을 사용하여 판매 시점에 그러한 반품을 추정하고 제공합니다.
비. 협업 및 라이선스 수익
진행 중인 연구 활동과 직접적인 관련이 없는 협업 또는 라이선스 계약과 관련하여 계약상 합의된 선불금 및 이와 유사한 환불 불가능한 지불금은 이연 소득으로 기록되고 예상 계약 기간 동안 수익으로 인식됩니다. 약정의 예상기간이 변경되면 수익을 인식하는 기간도 변경됩니다.
연구 개발 과정에서 중요하고 실질적인 기술적 또는 규제 장애물의 달성과 관련된 환불 불가능한 마일스톤 및 기타 지불금은 특정 마일스톤의 달성 시 수익으로 인식됩니다.
진행 중인 연구 활동과 관련된 소득은 계약에 따라 연구 활동이 수행됨에 따라 인식됩니다. 활동은 비용이 아닌 진행 상황과 이정표를 기준으로 측정됩니다.
씨. 기타 소득 - 개발 보조금
제품 개발 자금을 지원하기 위한 정부보조금의 형태로 수취할 수 있는 수입은 보조금이 보상하고자 하는 관련 적격 비용을 비용으로 인식하는 기간 동안 그리고 연결실체가 다음을 합리적으로 확신할 수 있는 기간 동안 개발보조금으로 인식합니다. 그들에게 첨부된 조건을 준수하고 수입을 받을 것입니다. 연결실체가 비유동자산을 매입 또는 취득하는 것을 주된 조건으로 하는 정부보조금은 관련 자산의 내용연수에 걸쳐 체계적이고 합리적으로 연결대차대조표에 이연수익으로 인식하고 연결포괄손익계산서로 이전하고 있습니다. 자산.
연구 개발
연구비는 발생시 즉시 제각됩니다. 개발비는 기술적, 상업적으로 확인되는 시점까지 발생한 비용으로 처리됩니다. 그 후 측정 가능하고 프로젝트에 귀속되는 비용은 다음 기준을 충족하는 경우 무형 자산으로 이월됩니다.
· 제품이 수익성 있는 미래 경제적 이익을 창출하고 제품을 판매할 의도와 능력을 입증합니다.
· 기술 타당성 평가;
· 개발을 완료하기 위한 기술, 재정 및 기타 자원의 가용성 확인;
· 경영진이 제품을 사용할 수 있도록 개발을 완료하려고 합니다. 그리고
· 개발에 귀속되는 지출을 신뢰성 있게 측정할 수 있습니다.
사용권 자산(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.
외화
(a) 기능통화 및 표시통화
각 연결실체의 재무제표에 포함되는 항목은 그 실체가 영업하는 주된 경제환경의 통화('기능통화')를 사용하여 측정됩니다. 연결 재무제표는 그룹의 표시 통화인 스털링으로 표시됩니다.
(b) 거래 및 잔액
외화거래는 거래일의 환율을 적용하여 기능통화로 환산하고 있습니다. 그러한 거래의 결제 및 외화로 표시된 화폐성 자산 및 부채의 연말 환율 환산으로 인한 외환 손익은 적격 순투자위험회피로 자본에 이연된 경우를 제외하고는 손익계산서에 인식됩니다. 공정가치로 장부금액이 높고 외화로 표시된 비화폐성 항목은 공정가치가 결정된 날의 환율로 재환산하고 있습니다.
3. 수익
수익은 받았거나 받을 대가의 공정가치에서 할인 및 판매관련 세금을 차감한 순액으로 측정하고 있습니다.
4. 영업부문
진단 세그먼트 | 행정 비용 | 금액 | |||
31년 2023월 XNUMX일 종료된 XNUMX개월 | £'000 | £'000 | £'000 | ||
수익 및 기타 소득 | 238 | - | 238 | ||
운영 손실 | (1,638) | (721) | (2,359) | ||
순 금융 비용 | (30) | ||||
과세 전 일반 활동 손실 | (2,389) | ||||
과세 재정적 손실 | 350 | ||||
재무 기간 동안의 손실 | (2,039) | ||||
| |||||
| 진단 세그먼트 | 행정 비용 | 금액 | ||
31년 2022월 XNUMX일 종료된 XNUMX개월 | £'000 | £'000 | £'000 | ||
수익 및 기타 소득 | 21 | - | 21 | ||
운영 손실 | (1,967) | (713) | (2,680) | ||
순 금융 비용 | (11) | ||||
과세 전 일반 활동 손실 | (2,691) | ||||
과세 재정적 손실 | 500 | ||||
재무 기간 동안의 손실 | (2,191) | ||||
| |||||
진단 세그먼트 | 행정 비용 | 금액 | |||
30년 2023월 XNUMX일에 종료된 XNUMX개월 | £'000 | £'000 | £'000 | ||
수익 및 기타 소득 | 55 | - | 55 | ||
운영 손실 | (3,869) | (1,355) | (5,224) | ||
순 금융 비용 | (757) | ||||
과세 전 일반 활동 손실 | (5,981) | ||||
과세 재정적 손실 | 831 | ||||
재무 기간 동안의 손실 | (5,150) |
5. 순금융비용
31월 XNUMX일 XNUMX월 | 31월 XNUMX일 XNUMX월 | 6월 30 | |
2023 | 2022 | 2023 | |
£000 | £000 | £000 | |
은행예금 순이자수익 | 18 | 5 | 30 |
Transaction costs relating to investment placing agreement | (40) | - | (81) |
Movement in fair value of derivative financial instrument | - | - | (675) |
금융리스 이자비용 | (8) | (16) | (31) |
(30) | (11) | (757) |
6. 당기법인세자산
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. 주당순이익
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. 몫 자본
할당, 발행 및 전액 지불: | 아니 |
£'000 | |
30년 2022월 31일 및 2022년 XNUMX월 XNUMX일 잔액 | 92,542,446 | 1,388 | |
주식발행 - 주식결제형 주식기준보상 | 7,500 | - | |
이슈 공유 | 6,500,000 | 97 | |
30 년 2023 월 XNUMX 일 잔액 | 99,049,946 | 1,485 | |
이슈 공유 | 23,390,000 | 351 | |
31 년 2023 월 XNUMX 일 잔액 | 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. 기타 준비금
프리미엄 계정 공유 £000 | 발행주식 £000 | 직원 공유 인센티브 계획 준비금 £000 | 공유 옵션 준비금 £000 | 역취득 준비금 £000 | 금액 £000 | |||||
30년 2022월 XNUMX일 | 52,426 | - | (196) | 1,560 | (2,496) | 51,294 | ||||
주식결제형 주식기준보상 | - | - | - | 34 | - | 34 | ||||
31년 2022월 XNUMX일 | 52,426 | - | (196) | 1,594 | (2,496) | 51,328 | ||||
투자 자금 조달 | 910 | 477 | - | - | - | 1,387 | ||||
이슈 공유 | - | - | - | - | - | - | ||||
주식결제형 주식기준보상 | - | - | - | 62 | - | 62 | ||||
30년 2023월 XNUMX일 | 53,336 | 477 | (196) | 1,656 | (2,496) | 52,777 | ||||
투자 자금 조달 | 916 | 197 | - | - | - | 1,113 | ||||
이슈 공유 | - | - | - | - | - | - | ||||
주식결제형 주식기준보상 | - | - | - | 40 | - | 40 | ||||
31년 2023월 XNUMX일 | 54,252 | 674 | (196) | 1,696 | (2,496) | 53,390 | ||||
RNS는 귀하의 IP 주소를 사용하여 약관 준수 여부를 확인하고, 귀하가 이 커뮤니케이션에 포함된 정보를 사용하는 방식을 분석하고, 그러한 분석을 익명으로 다른 사람과 상용 서비스의 일부로 공유할 수 있습니다. RNS와 런던 증권 거래소가 귀하가 제공한 개인 데이터를 사용하는 방법에 대한 자세한 내용은 개인 정보 보호 정책을 참조하십시오.