Angle PLC: Preliminary Results
GUILDFORD, UNITED KINGDOM--(Marketwired - Jul 27, 2017) -ANGLE PLC (
For Immediate Release 27 July 2017
OTCQX: ANPCY
ANGLE plc
("ANGLE" or "the Company")
Preliminary Results for the year ended 30 April 2017
FIRST LARGE SCALE PATIENT STUDIES WITH PARSORTIX COMPLETED
CLINICALLY SIGNIFICANT RESULTS IN OVARIAN CANCER
ANNOUNCED POST PERIOD END
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world leading liquid biopsy company, today announces unaudited results for the year ended 30 April 2017.
Operational Highlights
- Successfully completed US and European studies evaluating over 400 patients for detection of ovarian cancer in women with a high risk pelvic mass
- Reported positive results post period end: preliminary analyses indicated the potential for a Parsortix-based test to significantly out-perform current standard of care in discriminating between benign and malignant pelvic masses
- University of Texas MD Anderson Cancer Center selected to lead 400 subject study focused in metastatic breast cancer (MBC) to support FDA clearance of Parsortix system; results expected in H1 2018
- Barts Cancer Institute's prostate cancer studies showed rare cells harvested using the Parsortix system were linked to cancer metastasis and patient survival
- Increase in research use of Parsortix system by a wide range of leading cancer centres:
- Installed base of over 145 Parsortix instruments deployed worldwide (2016: 85) with over 30,000 blood separations completed (2016: 15,000)
- Cancer Research UK Manchester Institute selected Parsortix for routine use in clinical studies
- Parsortix accepted into the European CANCER ID programme
- Growing body of published evidence from internationally-recognised cancer centres help to validate the potential for Parsortix as a leading liquid biopsy solution
Financial Highlights
- Revenues increased to ?0.5 million (2016: ?0.4 million)
- Loss for the year ?6.4 million (2016: loss ?5.1 million) reflecting planned investment to advance clinical evidence through patient studies, FDA regulatory clearance and investment in marketing to drive adoption of Parsortix in research institutions
- Successful fundraising from major institutional investors raising ?10.2 million ( ?9.6 million net of expenses)
- Cash balance at 30 April 2017 of ?5.5 million (30 April 2016: ?3.8 million)
Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:
"ANGLE has made significant progress in its strategy towards commercialisation of Parsortix. Importantly, it recently announced positive results from two independent studies (c. 200 patients each) that highlighted the potential of the Parsortix system to facilitate the detection of ovarian cancer pre-surgery in women with high risk pelvic masses. Following optimisation of the Parsortix-based pelvic mass assay, the Company will validate the assay in a further, appropriately powered clinical validation study, with the goal of achieving regulatory clearance and subsequent commercialisation of this assay in Europe and the US.
Work on the pivotal clinical study in metastatic breast cancer is ongoing, with study results expected in H1 2018. The primary goal is to generate data that will support an FDA submission for use of the Parsortix system in harvesting cancer cells from metastatic breast cancer patients for subsequent evaluation.
With its differentiated competitive position, the growing body of clinical evidence and increasing research use, ANGLE is consolidating its position as a leading player in liquid biopsy; a potential multi-billion dollar market that is expected to revolutionise cancer care."
Details of webcast
Please see http://www.angleplc.com/investor-information/investor-centre/ for details.
For further information:
| ANGLE plc | 01483 343434 | |
| Andrew Newland, Chief Executive Ian Griffiths, Finance Director |
||
| Cenkos Securities Stephen Keys (Nominated adviser), Steve Cox Russell Kerr (Sales) |
020 7397 8900 | |
| WG Partners David Wilson Claes Sp??ng |
020 3705 9330 | |
| FTI Consulting Simon Conway, Mo Noonan, Stephanie Cuthbert Kimberley Ha (US) |
020 3727 1000 001 212 850 5612 |
For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/
This announcement contains inside information.
These Preliminary Results may contain forward-looking statements. These statements reflect the Board's current view, are subject to a number of material risks and uncertainties and could change in the future. Factors that could cause or contribute to such changes include, but are not limited to, the general economic climate and market conditions, as well as specific factors including the success of the Group's research and development and commercialisation strategies, the uncertainties related to regulatory clearance and the acceptance of the Group's products by customers.
CHAIRMAN'S STATEMENT
Introduction
The Company recently successfully completed its first two large scale studies, focused in the area of ovarian cancer. This has enabled ANGLE to move into the next significant stage of Parsortix's commercial development with the optimisation and validation of this first clinical application of the system.
Further progress has also been made with the metastatic breast cancer (MBC) studies, and MD Anderson has agreed to lead the 400 patient pivotal clinical study. The data generated will be used to support submission for FDA clearance for the proposed MBC intended use. Good progress has also been made on the analytical studies and headline results of both the analytical and clinical studies are expected in H1 2018.
Our key opinion leaders and research use customers are continuing to develop important new findings through their pilot studies, including areas of research that ANGLE has not itself previously considered, further strengthening the body of supportive evidence in new areas of cancer diagnosis and treatment.
Overview of Financial Results
Revenue of ?0.5 million (2016: ?0.4 million) came from sales of the Parsortix system for research use. Planned investment in studies to develop and validate the clinical application and commercial use of Parsortix increased, resulting in operating costs of ?7.8 million (2016: ?5.7 million). Thus, the loss for the year correspondingly increased to ?6.4 million (2016: ?5.1 million).
The cash balance was ?5.5 million at 30 April 2017 (30 April 2016: ?3.8 million). The financial position was strengthened during the year with a successful placing of shares with major institutional investors, which raised ?10.2 million gross ( ?9.6 million net of expenses).
Ovarian cancer clinical application: triaging abnormal pelvic mass
During the year, ANGLE undertook two investigational clinical studies in ovarian cancer, each involving the enrolment of c. 200 patients, conducted at leading cancer centres. The European study (ANG-001) was led by Dr Robert Zeillinger at the Medical University of Vienna and the US study (ANG-003) was led by Dr Richard Moore at the University of Rochester Medical Center, Wilmot Cancer Institute (New York State). These two studies were designed to evaluate the molecular interrogation of cells harvested from blood using the Parsortix system to detect ovarian cancer in women having surgery for an abnormal pelvic mass. The molecular interrogation of the cells harvested from the blood by the Parsortix system was undertaken with a variety of techniques, including those already widely available in hospital laboratories.
The results of these studies demonstrated the potential for a Parsortix based blood test to discriminate between benign and malignant pelvic masses with a high degree of accuracy, which would significantly out-perform current standard of care and address a significant unmet medical need.
An abnormal pelvic mass is a common condition in women, particularly older women. In the United States, around 750,000 women per annum are diagnosed and of these some 200,000 women per annum will have surgery on their pelvic mass. It is estimated that 5 to 10% of all women in developed countries will have surgery for an abnormal pelvic mass at some time in their lives. Most of these women, approximately 80 to 90%, will have a benign tumour, which could easily be treated by a general surgeon in the local hospital. However, approximately 10 to 20% will have a malignant tumour. Surgery for an ovarian cancer is highly complex, with the goal of achieving maximal tumour removal, and it should be performed by a specialist cancer surgeon to achieve optimal outcomes. A Parsortix-based test has the potential to allow women with a benign pelvic mass to be treated cost effectively in their local hospital, whilst ensuring patients whose masses are malignant are treated by a cancer specialist.
The preliminary results from these two studies indicate that the highest degree of discrimination can be achieved when combining selected gene information analysed from the Parsortix harvest with serum tumour markers in a multivariate algorithm. Optimisation of this proprietary algorithm is ongoing. Once finalised, it will be validated in an appropriately powered validation study. It is expected that it will be possible to apply for patent protection on the details of the algorithm, further strengthening ANGLE's competitive position.
The new test incorporates evaluation of the Parsortix harvested cells using an RNA-based assay to provide molecular information from nucleic acids obtained from intact cells, something which cannot be undertaken with ctDNA based techniques.
These successful results allow ANGLE to move forward into the next phase of product development, with the goal of commercialising a blood test addressing an estimated market size of ?300 million per annum. Firstly, additional work will be undertaken over an estimated six month period to optimise the algorithm for maximisation of performance. Some critical aspects of the downstream analysis techniques have been identified that ANGLE believes can be enhanced to improve the performance of the assay and provide an even stronger competitive advantage. The performance of the optimised test will be confirmed utilising a second blood sample that has been banked from each of the ANG-003 study patients and further patient and control blood samples.
Following optimisation, the performance of the final assay configuration and algorithm will be validated in a further, appropriately powered clinical validation study (or studies) designed to meet European in vitro device regulations and US FDA regulatory requirements over a 12 to 18 month period. The cancer centres involved will aim to publish the full results of the studies in leading peer-reviewed publications.
Successful data and publications from the validation will then allow for the commercialisation of the Parsortix based pelvic mass test in the United States and Europe, and eventually worldwide.
Opportunities will also be explored for the early accelerated commercialisation of the ovarian application via commercial partnerships.
FDA clearance in metastatic breast cancer
The Parsortix system must gain regulatory authorisations before it can be sold for use in clinical markets (for use in the diagnosis or management of patients). ANGLE already has a CE Mark for the indicated clinical use of the Parsortix system in Europe as a platform for harvesting cancer cells for analysis. Significant efforts are being made to secure a United States FDA clearance for use of the platform in the enrichment and harvesting of cancer cells from metastatic breast cancer patients for use in subsequent analyses. FDA clearance would not only allow sale of the product for clinical use in the United States, but would also validate the analytical performance of the system, thereby potentially influencing system adoption across both research and future clinical applications, worldwide.
During the year, the Company has completed several fundamental evaluations of the analytical performance of the Parsortix system. The University of Texas MD Anderson Cancer Center has been selected as the lead cancer centre for analysis of the pivotal clinical study covering the primary endpoint and one of the secondary endpoints for the study.
The pivotal clinical study is designed to collect blood samples from 200 metastatic breast cancer patients and 200 healthy volunteers of similar age and demographics. The blood samples will be processed using the Parsortix system to capture and harvest circulating tumour cells (CTCs). The harvested cells will be evaluated using several different downstream analysis techniques, with the results designed to support the following "Intended Use Statement" for the Parsortix?,,? PC1 system:
"The Parsortix?,,? PC1 instrument is an in vitro diagnostic device intended to harvest circulating tumor cells (CTCs) from the peripheral blood of patients diagnosed with metastatic breast cancer. The CTCs can be harvested from the instrument for subsequent analysis."
The clinical study will be initiated at each site once the participating centre has obtained Scientific Review Committee and ethics approvals and contractual arrangements are completed. All aspects of the pivotal clinical study, including the downstream analyses, will be undertaken by the independent cancer centres from blinded samples.
The speed of patient accrual is a key variable in the overall timing of the pivotal FDA clinical study. ANGLE is currently engaged with six different leading cancer centres across the United States to finalise contractual agreements and get IRB (institutional review board) approvals in place to enable these centres to enrol patients for the study. The aim is to complete the necessary analytical and clinical studies so that results are available in H1 2018. These will then form the basis of an FDA submission for clearance in metastatic breast cancer.
Once the breast cancer FDA clearance has been obtained, it is envisioned that additional studies will be conducted to allow for extension of the intended use to other cancer types, including ovarian and prostate cancer.
Breast cancer: blood test alternative to invasive metastatic biopsy
During the year, the University of Southern California (USC) Norris Comprehensive Cancer Center presented further work with Parsortix at the San Antonio Breast Cancer Symposium (SABCS 2016). Their findings continue to support the potential for the use of Parsortix as a liquid biopsy for metastatic breast cancer. Having assessed how best to progress this potential clinical application from the perspective of cost and speed to market, ANGLE has now included this form of gene expression analysis as an element of the pivotal FDA clinical study described above.
Prostate cancer: blood test alternative to prostate biopsy
During the year, Barts Cancer Institute presented further work with the Parsortix system as a poster at the National Cancer Research Institute (NCRI 2016). In a study of around 80 samples from men with prostate cancer, Barts reported that the mesenchymal CTCs captured by Parsortix, which are missed by antibody-based CTC systems and cannot be addressed by ctDNA-based assays, may have particular relevance in assessing the status of the disease.
Post period end, Barts reported in the peer-reviewed journal, Clinical Cancer Research, their findings using ANGLE's Parsortix system of a particularly interesting rare cell, identified by the researchers as megakaryocytes, in the blood of prostate cancer patients together with their discovery that the number of these cells in the blood correlates closely with increased patient survival. This is the first time that the presence of these cells in the blood has been shown to correlate with cancer prognosis.
The consequence of these findings is that, from a simple blood test, the Parsortix system has been shown to be capable of harvesting for analysis not only mesenchymal CTCs, which are linked to a poor outcome, but also cells, which are linked to a favourable patient outcome. Barts researchers showed in their 40 patient study that combining these two factors enabled the identification of patients 10 times more likely to die of their disease in the short term. This knowledge may point to more aggressive treatment earlier amongst this subset of patients, potentially improving outcomes.
Investigation of the presence and clinical potential of megakaryocytes in patient blood opens up a whole new area for cancer research and ANGLE's patented Parsortix system is the only system that has been demonstrated to be capable of harvesting these cells.
ANGLE is now working on plans to develop the commercial diagnostic potential of Barts' findings both in relation to earlier work on the detection of prostate cancer and the more recent work on detecting those with aggressive diseases. A clinical study of the use of Parsortix as an alternative, or pre-cursor, to solid prostate biopsy is also under consideration. Successful results from such a study would potentially mean that men without cancer could avoid unnecessary and potentially harmful solid biopsy and surgical intervention, whereas men with an aggressive form of disease could be fast-tracked for further investigation and treatment.
We believe a simple blood test to assess whether a solid prostate biopsy is warranted would improve patient care and help to reduce healthcare costs.
Research use sales
Following first research use sales of the Parsortix system in December 2015, good progress has been made during the period in building a sales pipeline in this market, which is estimated to be ?250 million per annum.
The installed base of Parsortix instruments is continuing to grow, standing at over 145 at 30 April 2017, up from c. 85 at 30 April 2016. Over 30,000 blood separations have now taken place with Parsortix, up from c. 15,000 at 30 April 2016.
Adoption of Parsortix into the customers' routine laboratory practice is evident from a substantial increase in revenues from cassette sales, which are up over 400% from last year. Overall research use Parsortix sales have increased over 40%.
Our sales team continue to focus on supporting our customers as they evaluate Parsortix in their current laboratory procedures, and we have seen a cumulative conversion rate for evaluations to sales of over 75%. However, evaluations are often complicated because of limitations in the analytical techniques being used downstream of the Parsortix system and the experimental nature of the research work being undertaken. At the year end, there were a further 20 prospective customers evaluating Parsortix systems with a view to purchase.
We are aware of research being undertaken with the Parsortix system that is funded and developed by third parties in 14 different cancer types, including:
| Breast cancer | Cervical cancer | |
| Colorectal cancer | Endometrial cancer | |
| Head and neck cancer | Hepatocellular cancer (liver) | |
| Melanoma | Neuroendocrine cancer | |
| Non-small cell lung cancer (NSCLC) | Ovarian cancer | |
| Pancreatic cancer | Prostate cancer | |
| Renal cancer (kidney) | Small cell lung cancer (SCLC) |
Half of the top ten breast cancer CTC researchers worldwide (as measured by the number of publications they have published on CTCs) have now adopted the Parsortix system for CTC harvest and analysis.
In the United States, over half of the 27 National Comprehensive Cancer Centres have either purchased the Parsortix system or are currently evaluating it for purchase.
In Europe, Parsortix has been selected for CANCER-ID, the European consortium comprising 38 partners from 13 countries funded by the Innovative Medicines Initiative to establish standard protocols and clinical validation of liquid biopsies.
Growing body of published evidence
The Parsortix system is now being adopted widely amongst leading researchers in the field, and as a result there is a growing body of published evidence from third party cancer centres in support of the Parsortix system.
There are now five publications in peer-reviewed journals (30 April 2016: 3). There are also 13 posters presented at international cancer conferences, which are publicly available. In addition, there have been numerous other posters presented, which have not yet been made publicly available as they are being prepared for peer-reviewed publications.
During the year, third parties presented research using Parsortix at a wide range of leading cancer conferences, including:
- EACR - European Association for Cancer Research
- AACR - American Association for Cancer Research
- AACC - American Association for Clinical Chemistry
- ASCO - American Society of Clinical Oncology
- NCRI - National Cancer Research Institute conference
- SABCS - San Antonio Breast Cancer Symposium
The rate of publication of third-party evidence is accelerating as research use customers publish their results. Peer reviewed published scientific data and Level 1 clinical evidence are fundamental to the Company's overall strategy aimed at the routine adoption of Parsortix as the system of choice for the harvesting of cancer cells from patient blood for analysis.
As a product-based company, ANGLE's ability to obtain wide adoption in the research field with consequent rapidly growing third party published evidence provides a strong advantage compared to the vast majority of competitors who have service laboratory-based offerings and have only their own work to rely on for published evidence.
Intellectual property further strengthened
Intellectual property protection around the Parsortix system continued to be strengthened during the year and the Parsortix system is now covered by granted patents in the United States, Europe, Australia, Canada, China and Japan. The increased patent protection extended the breadth and duration of patent coverage for the Parsortix system out to 2034. Additional patents are being pursued worldwide.
Importantly, this intellectual property position enables the Company to sell the Parsortix system as a product (comprising an instrument and consumable). Most of ANGLE's competitors in the liquid biopsy market have IP which relates only to the provision of a service. As such the competitors are dependent on a reference laboratory-based business model with all of the associated limitations to cost and scalability. ANGLE's Directors believe that the clinical customer base will prefer a product which enables them to conduct assays without the inconvenience of having to send samples to an external laboratory.
Outlook
ANGLE has made significant progress in its strategy towards commercialisation of Parsortix. Importantly, it recently announced positive results from two independent studies (c. 200 patients each) that highlighted the potential of the Parsortix system to facilitate the detection of ovarian cancer pre-surgery in women with high risk pelvic masses. Following optimisation of the Parsortix-based pelvic mass assay, the Company will validate the assay in a further, appropriately powered clinical validation study, with the goal of achieving regulatory clearance and subsequent commercialisation of this assay in Europe and the US.
Work on the pivotal clinical study in metastatic breast cancer is ongoing, with study results expected in H1 2018. The primary goal is to generate data that will support an FDA submission for use of the Parsortix system in harvesting cancer cells from metastatic breast cancer patients for subsequent evaluation.
With its differentiated competitive position, the growing body of clinical evidence and increasing research use, ANGLE is consolidating its position as a leading player in liquid biopsy; a potential multi-billion dollar market that is expected to revolutionise cancer care.
Garth Selvey
Chairman
26 July 2017
| ANGLE PLC | ||||
| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME | ||||
| FOR THE YEAR ENDED 30 APRIL 2017 | ||||
| 2017 | 2016 | |||
| (Unaudited) | (Audited) | |||
| Note | ?'000 | ?'000 | ||
| Revenue | 498 | 361 | ||
| Cost of sales | (123) | (107) | ||
| Gross profit | 375 | 254 | ||
| Operating costs | (7,810) | (5,703) | ||
| Operating profit/(loss) from continuing operations | (7,435) | (5,449) | ||
| Net finance income/(costs) | 25 | 22 | ||
| Profit/(loss) before tax from continuing operations | (7,410) | (5,427) | ||
| Tax (charge)/credit | 5 | 1,018 | 309 | |
| Profit/(loss) for the year from continuing operations | (6,392) | (5,118) | ||
| Profit/(loss) from discontinued operations | - | 32 | ||
| Profit/(loss) for the year | (6,392) | (5,086) | ||
| Other comprehensive income/(loss) | ||||
| Items that may be subsequently reclassified to profit or loss | ||||
| Exchange differences on translating foreign operations | 139 | (7) | ||
| Other comprehensive income/(loss) | 139 | (7) | ||
| Total comprehensive income/(loss) for the year | (6,253) | (5,093) | ||
| Profit/(loss) for the year attributable to: | ||||
| Owners of the parent | ||||
| From continuing operations | (6,147) | (4,924) | ||
| From discontinued operations | - | 31 | ||
| Non-controlling interests | ||||
| From continuing operations | (245) | (194) | ||
| From discontinued operations | - | 1 | ||
| Profit/(loss) for the year | (6,392) | (5,086) | ||
| Total comprehensive income/(loss) for the year attributable to: | ||||
| Owners of the parent | ||||
| From continuing operations | (5,994) | (4,978) | ||
| From discontinued operations | - | 31 | ||
| Non-controlling interests | ||||
| From continuing operations | (259) | (147) | ||
| From discontinued operations | - | 1 | ||
| Total comprehensive income/(loss) for the year | (6,253) | (5,093) | ||
| Earnings/(loss) per share | ||||
| Basic and Diluted (pence per share) | ||||
| From continuing operations | (8.71) | (8.69) | ||
| From discontinued operations | - | 0.05 | ||
| From continuing and discontinued operations | 6 | (8.71) | (8.64) | |
| ANGLE PLC | |||||
| CONSOLIDATED STATEMENT OF FINANCIAL POSITION | |||||
| AS AT 30 APRIL 2017 | |||||
| Note | 2017 | 2016 | |||
| (Unaudited) | (Audited) | ||||
| ?'000 | ?'000 | ||||
| ASSETS | |||||
| Non-current assets | |||||
| Property, plant and equipment | 824 | 455 | |||
| Intangible assets | 7 | 1,918 | 1,346 | ||
| Total non-current assets | 2,742 | 1,801 | |||
| Current assets | |||||
| Inventories | 665 | 376 | |||
| Trade and other receivables | 714 | 489 | |||
| Taxation | 1,261 | 309 | |||
| Cash and cash equivalents | 5,536 | 3,764 | |||
| Total current assets | 8,176 | 4,938 | |||
| Total assets | 10,918 | 6,739 | |||
| EQUITY AND LIABILITIES | |||||
| Equity | |||||
| Share capital | 9 | 7,482 | 5,898 | ||
| Share premium | 33,285 | 25,299 | |||
| Share-based payments reserve | 822 | 629 | |||
| Other reserve | 2,553 | 2,553 | |||
| Translation reserve | 132 | (21) | |||
| Retained earnings | (34,227) | (28,141) | |||
| ESOT shares | (102) | (102) | |||
| Equity attributable to owners of the parent | 9,945 | 6,115 | |||
| Non-controlling interests | (1,139) | (880) | |||
| Total equity | 8,806 | 5,235 | |||
| Liabilities | |||||
| Current liabilities | |||||
| Trade and other payables | 8 | 2,112 | 1,504 | ||
| Total current liabilities | 2,112 | 1,504 | |||
| Total liabilities | 2,112 | 1,504 | |||
| Total equity and liabilities | 10,918 | 6,739 | |||
| ANGLE PLC | |||||
| CONSOLIDATED STATEMENT OF CASH FLOWS | |||||
| FOR THE YEAR ENDED 30 APRIL 2017 | |||||
| 2017 | 2016 | ||||
| (Unaudited) | (Audited) | ||||
| ?'000 | ?'000 | ||||
| Operating activities | |||||
| Profit/(loss) before tax from continuing operations | (7,410) | (5,427) | |||
| Adjustments for: | |||||
| Depreciation of property, plant and equipment | 267 | 198 | |||
| (Profit)/loss on disposal of property, plant and equipment | 5 | - | |||
| Amortisation and impairment of intangible assets | 245 | 187 | |||
| Exchange differences | (50) | (65) | |||
| Net finance (income)/costs | (25) | (22) | |||
| Share-based payments | 254 | 238 | |||
| Operating cash flows before movements in working capital: | (6,714) | (4,891) | |||
| (Increase)/decrease in inventories | (575) | (238) | |||
| (Increase)/decrease in trade and other receivables | (290) | (107) | |||
| Increase/(decrease) in trade and other payables | 131 | 474 | |||
| Operating cash flows | (7,448) | (4,762) | |||
| Research and development tax credits received | 65 | - | |||
| Net cash from/(used in) operating activities | (7,383) | (4,762) | |||
| Investing activities | |||||
| Purchase of property, plant and equipment | (70) | (186) | |||
| Purchase of intangible assets | (374) | (332) | |||
| Interest received | 26 | 21 | |||
| Net cash from/(used in) investing activities | (418) | (497) | |||
| Financing activities | |||||
| Net proceeds from issue of share capital | 9,570 | 1 | |||
| Net cash from/(used in) financing activities | 9,570 | 1 | |||
| Net increase/(decrease) in cash and cash equivalents from continuing operations | 1,769 | (5,258) | |||
| Discontinued operations | |||||
| Net cash from/(used in) operating activities | (5) | (34) | |||
| Net cash from/(used in) investing activities | - | 611 | |||
| Net increase/(decrease) in cash and cash equivalents from discontinued operations | (5) | 577 | |||
| Net increase/(decrease) in cash and cash equivalents | 1,764 | (4,681) | |||
| Cash and cash equivalents at start of year | 3,764 | 8,443 | |||
| Effect of exchange rate fluctuations | 8 | 2 | |||
| Cash and cash equivalents at end of year | 5,536 | 3,764 | |||
| ANGLE PLC | ||||||||||||
| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | ||||||||||||
| FOR THE YEAR ENDED 30 APRIL 2017 | ||||||||||||
| Equity attributable to owners of the parent | ||||||||||||
| Share-based | ||||||||||||
| Share | Share | payments | Other | Translation | ||||||||
| capital | premium | reserve | reserve | reserve | ||||||||
| ?'000 | ?'000 | ?'000 | ?'000 | ?'000 | ||||||||
| At 1 May 2015 (Audited) | 5,897 | 25,299 | 432 | 2,553 | 33 | |||||||
| For the year to 30 April 2016 | ||||||||||||
| Consolidated profit/(loss) | ||||||||||||
| Other comprehensive income/(loss) | ||||||||||||
| Exchange differences on translating foreign operations | (54) | |||||||||||
| Total comprehensive income/(loss) | (54) | |||||||||||
| Issue of shares | 1 | - | ||||||||||
| Share-based payments | 238 | |||||||||||
| Released on deemed disposal | (41) | |||||||||||
| Deemed disposal of controlling interest in investment | ||||||||||||
| At 30 April 2016 (Audited) | 5,898 | 25,299 | 629 | 2,553 | (21) | |||||||
| For the year to 30 April 2017 | ||||||||||||
| Consolidated profit/(loss) | ||||||||||||
| Other comprehensive income/(loss) | ||||||||||||
| Exchange differences on translating foreign operations | 153 | |||||||||||
| Total comprehensive income/(loss) | 153 | |||||||||||
| Issue of shares | 1,584 | 7,986 | ||||||||||
| Share-based payments | 254 | |||||||||||
| Released on exercise | (1) | |||||||||||
| Released on forfeiture | (60) | |||||||||||
| At 30 April 2017 (Unaudited) | 7,482 | 33,285 | 822 | 2,553 | 132 | |||||||
| Equity attributable to owners of the parent | ||||||||||||
| Total | Non- | |||||||||||
| Retained | ESOT | Shareholders' | controlling | Total | ||||||||
| earnings | shares | equity | interests | equity | ||||||||
| ?'000 | ?'000 | ?'000 | ?'000 | ?'000 | ||||||||
| At 1 May 2015 (Audited) | (23,260) | (102) | 10,852 | (763) | 10,089 | |||||||
| For the year to 30 April 2016 | ||||||||||||
| Consolidated profit/(loss) | (4,893) | (4,893) | (193) | (5,086) | ||||||||
| Other comprehensive income/(loss) | ||||||||||||
| Exchange differences on translating foreign operations | (54) | 47 | (7) | |||||||||
| Total comprehensive income/(loss) | (4,893) | (4,947) | (146) | (5,093) | ||||||||
| Issue of shares | 1 | 1 | ||||||||||
| Share-based payments | 238 | 238 | ||||||||||
| Released on deemed disposal | 41 | - | - | |||||||||
| Deemed disposal of controlling interest in investment | (29) | (29) | 29 | - | ||||||||
| At 30 April 2016 (Audited) | (28,141) | (102) | 6,115 | (880) | 5,235 | |||||||
| For the year to 30 April 2017 | ||||||||||||
| Consolidated profit/(loss) | (6,147) | (6,147) | (245) | (6,392) | ||||||||
| Other comprehensive income/(loss) | ||||||||||||
| Exchange differences on translating foreign operations | 153 | (14) | 139 | |||||||||
| Total comprehensive income/(loss) | (6,147) | (5,994) | (259) | (6,253) | ||||||||
| Issue of shares | 9,570 | 9,570 | ||||||||||
| Share-based payments | 254 | 254 | ||||||||||
| Released on exercise | 1 | - | - | |||||||||
| Released on forfeiture | 60 | - | - | |||||||||
| At 30 April 2017 (Unaudited) | (34,227) | (102) | 9,945 | (1,139) | 8,806 | |||||||
ANGLE PLC
NOTES TO THE PRELIMINARY ANNOUNCEMENT
FOR THE YEAR ENDED 30 APRIL 2017
1 Preliminary announcement
The preliminary announcement set out above does not constitute ANGLE plc's statutory Financial Statements for the years ended 30 April 2017 or 2016 within the meaning of section 434 of the Companies Act 2006.
The financial information for the year ended 30 April 2017 is unaudited and an auditor's report has not yet been issued. Statutory audited financial statements for the year will be finalised on the basis of the financial information presented by the directors in this preliminary announcement.
The financial information for the year ended 30 April 2016 is derived from the audited financial statements for that year and the auditor's report on the consolidated Financial Statements for the year ended 30 April 2016 is unqualified and does not contain statements under s498(2) or (3) of the Companies Act 2006.
The accounting policies used for the year ended 30 April 2017 are unchanged from those used for the statutory Financial Statements for the year ended 30 April 2016, except as referred to in Note 2. The 2017 statutory accounts will be delivered to the Registrar of Companies following the Company's Annual General Meeting.
2 Compliance with accounting standards
While the financial information included in this preliminary announcement has been computed in accordance with IFRS, this announcement does not itself contain sufficient information to comply with IFRS.
Accounting standards adopted in the year
No new accounting standards that have become effective and adopted in the year have had a significant effect on the Group's Financial Statements.
Accounting standards issued but not yet effective
At the date of authorisation of the Financial Statements, there were a number of other Standards and Interpretations (International Financial Reporting Interpretation Committee - IFRIC) which were in issue but not yet effective, and therefore have not been applied in these Financial Statements. The Directors have not yet assessed the impact of the adoption of these standards and interpretations for future periods.
A number of other accounting policies have been slightly amended and updated for readability.
3 Going concern
The Financial Statements have been prepared on a going concern basis which assumes that the Group will be able to continue its operations for the foreseeable future.
The Group's business activities, together with the factors likely to affect its future development, performance and financial position are set out in the Chairman's Statement.
The Directors have prepared and reviewed the financial projections for the 12 month period from the date of signing of these Financial Statements. Based on the level of existing cash, the projected income and expenditure (the timing of some of which is at the Group's discretion) and other potential sources of funding, the Directors have a reasonable expectation that the Company and Group have adequate resources to continue in business for the foreseeable future. Accordingly the going concern basis has been used in preparing the Financial Statements.
4 Critical accounting estimates and judgements
The preparation of the Financial Statements requires the use of estimates, assumptions and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates, assumptions and judgements are based on management's best knowledge of the amounts, events or actions, and are believed to be reasonable, actual results ultimately may differ from those estimates.
The estimates, assumptions and judgements that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities are described below.
Valuation, amortisation and impairment of intangible assets (Note 7)
IAS 38 Intangible Assets contains specific criteria that if met mean development expenditure must be capitalised as an internally generated intangible asset. Judgements are required in both assessing whether the criteria are met and then in applying the rules. Intangible assets are amortised over their useful lives. Useful lives are assessed by reference to observable data (e.g. remaining patent life) and taking into consideration specific product (e.g. product life cycle) and market characteristics (e.g. estimates of the period that the assets will generate revenue). Each of these factors is periodically reviewed for appropriateness. Changes to estimates in useful lives may result in significant variations in the amortisation charge.
The Group is required to review, at least annually, whether there are indications (events or changes in circumstances) that intangible assets have suffered impairment and that the carrying amount may exceed the recoverable amount. If there are indications of impairment then an impairment review is undertaken. The recoverable amount is the higher of the asset's fair value less costs to sell and its value-in-use. The value-in-use method requires the estimation of future cash flows and the selection of a suitable discount rate in order to calculate the present value of these cash flows. When reviewing intangible assets for impairment the Group has had to make various assumptions and estimates of individual components and their potential value and potential impairment impact. The Group considers that for each of these variables there is a range of reasonably possible alternative values, which results in a range of fair value estimates. None of these estimates of fair value is considered more appropriate or relevant than any other and therefore determining a fair value requires considerable judgement.
Share-based payments
In calculating the fair value of equity-settled share-based payments the Group uses an options pricing model. The Directors are required to exercise their judgement in choosing an appropriate options pricing model and determining input parameters that may have a material effect on the fair value calculated. These input parameters include, among others, expected volatility, expected life of the options taking into account exercise restrictions and behavioural considerations of employees, the number of options expected to vest and liquidity discounts.
Research and development tax credit (Note 5)
Management makes its best estimate of qualifying R&D expenditure to calculate the R&D tax credit. The interpretation of qualifying expenditure requires judgement.
Deferred tax assets
The Group has unused tax losses. Management judgement is required to determine the amount of deferred tax assets that can be recognised, based upon the likely timing and level of future taxable profits together with an assessment of the effect of future tax planning strategies. Changes in these judgements and assumptions could have a material impact on the Group's reported tax charge.
5 Tax
The Group undertakes research and development activities. In the UK these activities qualify for tax relief resulting in tax credits.
6 Earnings/(loss) per share
The basic and diluted earnings/(loss) per share is calculated on the loss for the year from continuing and discontinued operations of ?6.4 million (2016: ?5.1 million).
In accordance with IAS 33 Earnings per share 1) the "basic" weighted average number of ordinary shares calculation excludes shares held by the Employee Share Ownership Trust (ESOT) as these are treated as treasury shares and 2) the "diluted" weighted average number of ordinary shares calculation considers potentially dilutive ordinary shares from instruments that could be converted. Share options are potentially dilutive where the exercise price is less than the average market price during the period. Due to the losses in 2017 and 2016, share options are non-dilutive for those years as adding them would have the effect of reducing the loss per share and therefore the diluted loss per share is equal to the basic loss per share.
The basic and diluted earnings/(loss) per share are based on a weighted average of 73,350,486 ordinary 10p shares (2016: 58,863,713).
7 Intangible assets
| Intellectual | Computer | Product | Total | |||||
| property | software | development | ||||||
| ?'000 | ?'000 | ?'000 | ?'000 | |||||
| Cost | ||||||||
| At 1 May 2015 | 286 | 12 | 1,191 | 1,489 | ||||
| Additions | 241 | 1 | 90 | 332 | ||||
| Disposals | (94) | (7) | - | (101) | ||||
| Exchange movements | 9 | - | 58 | 67 | ||||
| At 30 April 2016 | 442 | 6 | 1,339 | 1,787 | ||||
| Additions | 209 | 1 | 462 | 672 | ||||
| Disposals | - | (5) | - | (5) | ||||
| Exchange movements | 26 | - | 168 | 194 | ||||
| At 30 April 2017 | 677 | 2 | 1,969 | 2,648 | ||||
| Amortisation and impairment | ||||||||
| At 1 May 2015 | 94 | 10 | 236 | 340 | ||||
| Charge for the year | 2 | 1 | 124 | 127 | ||||
| Disposals | (94) | (7) | - | (101) | ||||
| Impairment | 60 | - | - | 60 | ||||
| Exchange movements | - | - | 15 | 15 | ||||
| At 30 April 2016 | 62 | 4 | 375 | 441 | ||||
| Charge for the year | 13 | 1 | 142 | 156 | ||||
| Disposals | - | (5) | - | (5) | ||||
| Impairment | 89 | - | - | 89 | ||||
| Exchange movements | - | - | 49 | 49 | ||||
| At 30 April 2017 | 164 | - | 566 | 730 | ||||
| Net book value | ||||||||
| At 30 April 2017 | 513 | 2 | 1,403 | 1,918 | ||||
| At 30 April 2016 | 380 | 2 | 964 | 1,346 | ||||
The carrying value of intangible assets is reviewed for indications of impairment whenever events or changes in circumstances indicate that the carrying value may exceed the recoverable amount. The recoverable amount is the higher of the asset's fair value less costs to sell and its "value-in-use". The key assumptions to assess value-in-use are the estimated useful economic life, future revenues, cash flows and the discount rate to determine the net present value of these cash flows. Where value-in-use exceeds the carrying value then no impairment is made. Where value-in-use is less than the carrying value then an impairment charge is made.
During the period the Group decided to abandon a particular patent application which resulted in an impairment charge.
Amortisation and impairment charges are charged to operating costs in the Consolidated Statement of Comprehensive Income.
"Product development" relates to internally generated assets that were capitalised in accordance with IAS 38 Intangible Assets. Capitalised product development costs are directly attributable costs comprising cost of materials, specialist contractor costs, labour and overheads. Product development costs are amortised over their estimated useful lives commencing when the related new product is in commercial production. Development costs not meeting the IAS 38 criteria for capitalisation continue to be expensed through the Statement of Comprehensive Income as incurred.
8 Trade and other payables
| 2017 | 2016 | |||
| (Unaudited) | (Audited) | |||
| ?'000 | ?'000 | |||
| Current liabilities: | ||||
| Trade payables | 980 | 417 | ||
| Other taxes and social security costs | 71 | 57 | ||
| Other payables | 1 | 41 | ||
| Accruals and deferred income | 1,060 | 989 | ||
| 2,112 | 1,504 |
Accruals include amounts for professional fees, vacation, salary and bonuses. Deferred income includes amounts for pre-billed revenues.
9 Share capital
The Company has one class of ordinary shares which carry no right to fixed income and at 30 April 2017 had 74,815,774 ordinary shares of 10p each allotted, called up and fully paid (2016: 58,978,338).
The Company issued 15,815,436 new ordinary shares with a nominal value of ?0.10 at an issue price of ?0.645 per share in a placing. Shares were admitted to trading on AIM in May 2016.
The Company issued 22,000 new ordinary shares with a nominal value of ?0.10 at an exercise price of ?0.2575 per share as a result of the exercise of share options by an employee. Shares were admitted to trading on AIM in September 2016.
10 Shareholder communications
Copies of this announcement are posted on the Company's website www.ANGLEplc.com.
The Annual General Meeting of the Company will be held at 2:00pm on Tuesday 31 October 2017 at ANGLE plc, 10 Nugent Road, the Surrey Research Park, Guildford, GU2 7AF. Notice of the meeting will be enclosed with the audited Statutory Financial Statements.
The audited Statutory Financial Statements for the year ended 30 April 2017 are expected to be distributed to shareholders by 6 October 2017 and will subsequently be available on the Company's website or from the registered office, 10 Nugent Road, Surrey Research Park, Guildford, GU2 7AF.
This preliminary announcement was approved by the Board on 26 July 2017.
ANGLE plc
Andrew Newland
Chief Executive
Ian Griffiths
Finance Director
01483 343434
Cenkos Securities
Stephen Keys (Nominated adviser)
Steve Cox
Russell Kerr (Sales)
020 7397 8900
WG Partners
David Wilson
Claes Sp??ng
020 3705 9330
FTI Consulting
Simon Conway
Mo Noonan
Stephanie Cuthbert
020 3727 1000
Kimberley Ha (US)
001 212 850 5612