Regis Annual Report 2019

Plain-text annual report

Annual Report 2019 Regeneus Ltd ABN 13 127 035 358 Contents Letter from the Chairman and the CEO Directors’ report Auditor’s independence declaration Consolidated statement of profit or loss and other comprehensive income Consolidated statement of financial position Consolidated statement of changes in equity Consolidated statement of cash flows Notes to the consolidated financial statements Directors’ declaration Independent auditor’s report Additional Shareholder Information Corporate Directory i 3 14 15 16 17 18 19 45 46 49 51 WHO WE ARE Regeneus Ltd (ASX: RGS) is a Sydney-based clinical-stage regenerative medicine company using stem cell technologies to develop a portfolio of novel cell-based therapies to address significant unmet medical needs in the human health markets with a focus on osteoarthritis and other musculoskeletal disorders, neuropathic pain and dermatology. Consolidated Financial Statements for the Year Ended 30 June 2019 Letter from the Chairman and the CEO Dear fellow shareholders On behalf of the Board of Directors we are pleased to present Regeneus’ annual report for the 2019 financial year. 2019 was a productive year with a number of important milestones. In particular, we announced the appointment of a new Chief Executive Officer, Leo Lee, who announced a new vision and refreshed strategy for Regeneus. We are pleased to report the team has already taken steps to execute this strategy over the last few months. As we move into the 2020 fiscal year, we are focused on continuing this momentum. We believe Regeneus is now in a strong position to execute our new strategy: to develop and commercialise therapies that treat pain and modify the underlying diseases which cause pain. Operational changes to support revised Company strategy In January 2019, we appointed Leo Lee as CEO. Leo has strong experience in the global pharmaceutical industry, being the former president of Japan for both Merck and Allergan, and has already made significant contributions to Regeneus in his role by establishing our new strategic direction. Leo’s appointment was followed by the appointment of two new Non-Executive Directors, Dr John Chiplin and Dr Alan W. Dunton, who joined Regeneus in April. Both John and Alan are industry leaders and bring significant experience in leading large-scale and biotechnology companies internationally. Their appointments were in conjunction with Barry Sechos being appointed as Non-Executive Chairman. sciences life Since Leo’s appointment, the Company has outlined its new strategy focused on addressing the large and growing pain market currently worth US$69 billion. This is a significant market opportunity and we platform believe Regeneus’ an technologies important role in helping meet an unmet clinical need. play can Japan is a well-developed market for osteoarthritis and other musculoskeletal diseases and we look forward to updating shareholders on progress on this front. To help optimise the commercial potential for Regeneus’ technologies, in parallel to the Japan commercialisation deal, the Company is also aiming to secure a commercial partner in the EU and US to advance clinical developments in these important markets. At the same time, we will seek to explore Regeneus is targeting a product launch in Japan for Progenza for the treatment of osteoarthritis in 2023 and is focused on securing a Japanese commercialisation deal in the near term to support this. A key priority to begin capturing this market, and executing on our strategy, is the completion of a Phase 2 trial and the commercialisation of Progenza for the treatment of osteoarthritis. This is our immediate focus in the 2020 financial year. Regeneus is targeting a product launch in Japan in 2023 and is focused on securing a Japanese commercialisation partnership in the near term. additional therapies in pain using the Progenza and Sygenus platform. Pre- clinical animal studies for both technologies have demonstrated positive outcomes in the treatment of pain and disease modification, and we intend to pursue a scientific partnership model to develop a second indication for Progenza, and a first indication for Sygenus for commercialisation Regeneus is now in a strong position to execute our new strategy: to develop and commercialise therapies that treat pain and modify the underlying diseases which cause pain. Consolidated Financial Statements for the Year Ended 30 June 2019 i Clinical and regulatory milestones support platform technology commercialisation During the year, we secured a number of clinical milestones for our platform technologies. trial results In particular, the Company announced positive preclinical for Progenza for the treatment of allodynia, a condition in pain occurs from what is normally non-painful stimulation of the skin, such as a light touch. These early- stage results are encouraging and support the opportunity for the Progenza platform technology to treat pain as well as modify the underlying diseases which cause pain. We are pleased to have also secured a range of patents in China and Europe for the use of mesenchymal stem cells (MSCs), which help support our MSCs therapies in these important markets. Worthy of note is that Regeneus received a notice of intent from the European Patent Office to grant a European patent for Progenza across multiple countries, laying the development of this platform in the region. foundations the for for our Phase Aside from our progress in Progenza and Sygenus, we also announced positive results I safety and tolerability ACTIVATE trials, the first trial tumour for RGSH4K, our autologous vaccine product for solid tumours. These results are encouraging and enhance the value of this asset as we explore the potential to divest it under our revised corporate strategy. Financial highlights Our financial results for the 2019 financial year demonstrate our commitment to deliver on our restructure and revised strategy. Outlook Looking ahead into the 2020 financial year, the Company is now more robust with our restructure and we look forward to advancing our platform technologies, particularly Progenza. We look forward to continuing the rollout of our revised Company strategy and meeting the milestones for the year ahead. to target $3.8 million The Board and management had already reduce outlined a clear borrowings. The in borrowings, as at 30 June 2019, was reduced to $1.1 million in October 2019, following the recent receipt of the R&D Tax Incentive rebate. During the first quarter of 2020, the company completed a $5.5 million capital raise. This capital raise was well- supported by new and existing investors and directors. This important validation of our revised strategic direction and overall vision for Regeneus. is an While lying outside the financial year, we recently announced a series of cost- containment initiatives that align with our strategic priorities. This includes reducing our operating costs to $250,000 a month, representing a 50 per cent reduction year- on-year. We believe these activities will strengthen the Company’s cash position while we focus on commercialising Progenza for osteoarthritis in Japan. The adoption of a scientific partnership model, where Regeneus partners with leading university and research bodies, will support the funding and clinical activities required to develop therapies using Progenza and Sygenus to target new indications. In the new financial year, we are focused on completing Phase 2 trial and the commercialisation of Progenza for the treatment of osteoarthritis, with the aim of a product launch in Japan in 2023. In parallel, we expect our new - scientific partnership model which sees us partnering with leading university and research bodies - will allow us to develop both the Progenza and Sygenus platforms and generate long term shareholder value. like thank our We would fellow to directors, the team and our clinical and research partners for their ongoing efforts and the important contributions business over the past financial year. to Finally, we thank our shareholders for continuing to support Regeneus as we continue to execute our new strategic the global pain direction market. As we roll out these initiatives, we appreciate your patience and look forward to updating you on our progress. to address Barry Sechos Chairman Leo Lee Chief Executive Officer Consolidated Financial Statements for the Year Ended 30 June 2019 ii Directors’ Report Chairman Barry Sechos has served on the Board since 2012 and has over 30 years experience as a director, business executive and corporate lawyer with particular experience in investment and asset management. Barry is Executive Director of the Sherman Group (an early- stage investor in the Company) and sits on the board of many Sherman Group of companies and investee companies. Other current directorships Concentrated Leaders Fund Ltd Previous directorships (last 3 years) None Interests in shares 200,000 Interests in options Nil Interests in options Nil CEO - Executive Director Leo Lee joined the Board on 11 December 2017. Leo brings more than 20 years of experience in pharmaceutical innovation, commercialisation, regulation and policy development and has worked extensively in North America and Asia. Most recently, Mr. Lee served as President, Japan, for Merck KGaA. Prior to this role, he served as President, Japan, for Allergan plc, a global pharmaceutical company. Leo has held sales and commercial roles in Merck & Co., IQVIA and Accelrys, Inc Leo received a Bachelor of Science in Molecular Genetics and Microbiology from the University of California. Other current directorships None Previous directorships (last 3 years) None Interests in shares 1,011,000 Interests in options 5,000,000 Your Directors present their report for Regeneus Ltd and its controlled entities (the Group) for the ﬁnancial year ended 30 June 2019. Directors The names of the Directors in ofﬁce at any time during or since the end of the year are: Barry Sechos Non-executive Chairman Leo Lee CEO and Executive Director Professor Graham Vesey CSO and Executive Director Dr. Glen Richards Non-executive Director Dr Alan Dunton Non-executive Director Appointed 28 April 2019 Dr John Chiplin Non-executive Director Appointed 28 April 2019 Dr. Roger Aston Non-executive Director Resigned 28 April 2019 John Martin Executive Director Resigned 28 April 2019 Directors have been in ofﬁce since the start of the ﬁnancial year to the date of this report unless otherwise stated. Consolidated Financial Statements for the Year Ended 30 June 2019 3 CSO - Executive Director Professor Graham Vesey is a co- founder and founding CEO of the Company and has served on the Board since incorporation. He was appointed Chief Scientific Ofﬁcer in November 2014. Graham is a successful biotechnology entrepreneur, technology innovator and inventor and a highly regarded scientist. Graham was a co- founder and Executive Director of the successful biotech company, BTF, which was sold to bioMerieux in 2007. Graham is an Adjunct Professor at Macquarie University. Other current directorships None Non-executive Directors Dr. Glen Richards has served on the Board since April 2015. Glen practised companion animal medicine and surgery in Brisbane, Townsville and London before establishing Greencross Vets in 1994. As Managing Director of Greencross Ltd (ASX:GXL) he created Australia’s largest veterinary healthcare group with over 120 veterinary practices and 200 pet specialty stores. He resigned as MD in December 2014 and continues as a Non-executive Director. Other current directorships Greencross Ltd 1300Smiles Ltd People Infrastructure Ltd Previous directorships (last 3 years) None Previous directorships (last 3 years) None Interests in shares 15,879,968 Interests in options Nil Interests in shares 2,333,333 Interests in options Nil Dr. Alan Dunton joined the Board in April 2019. Dr Dunton is a senior pharmaceutical and biotechnology industry leader with over 35 years of experience in senior company leadership roles. Dr Dunton has served as a director of 18 companies and is based in Florida, USA. He is the founder and principal of Danerius, LLC a consultancy that provides specialised advisory services to pharmaceutical and biotechnology organisations both in the private and public sectors. Over the last few years, Dr Dunton has also served as an independent board director for a variety of publicly-listed biopharmaceutical and drug development companies such as Palatin Technologies, Oragenics and CorMedix and the private company Cytogel Pharma. Other current directorships None Previous directorships (last 3 years) None Interests in shares Nil Interests in options Nil Dr. John Chiplin joined the Board in April 2019. Dr. Chiplin is Managing Director of Newstar Ventures Ltd and has significant operational, investment and transactions experience in the international life science and technology industries. Between 1995 and 2014, Dr Chiplin served as CEO at three leading publicly-listed software, biotechnology and cancer immunotherapy companies. Based in London, UK, Dr. Chiplin currently serves on the boards of Adalta (ASX: 1AD), Batu Biologics, Scancell Holdings plc (LSE: SCLP, Chairman) and ScienceMedia. Other current directorships Adalta Ltd Previous directorships (last 3 years) Cynata Therapeutics Ltd Interests in shares Nil Interests in options Nil Company Secretary Sandra McIntosh is the Company Secretary and Investor Relations Manager. Sandra has been with the Company since 2009, and has 20 years management experience in HR, customer service and ﬁnance. Consolidated Financial Statements for the Year Ended 30 June 2019 4 Principal activities Revenue from operating activities Regeneus Ltd (ASX: RGS) is a Sydney-based clinical-stage regenerative medicine company using stem cell technologies to develop a portfolio of novel cell-based therapies to address significant unmet medical needs in the human health markets with a focus on osteoarthritis and other musculoskeletal disorders, neuropathic pain and dermatology. Operating and ﬁnancial review Review of operations The 2019 year was one of consolidation of activities and development of licence opportunities. During the year, R&D was focussed on Progenza and Sygenus. Highlights of the year in review include: Operating activities Licence fee income Income from sale of goods Interest received Other income Total revenue 2019 $’000 2018 $’000 Movement $’000 - - 19 6 25 576 - 35 - 611 (576) - (16) 6 (586) The FY18 results included residual technology licence fees. It is anticipated that licence fees will increase in FY20 resulting from the appointment of a clinical partner in Japan. Appointed Leo Lee as CEO (previously non-executive Director) and appointed two new Non-executive Directors; Dr John Chiplin and Dr Alan W. Dunton Expenses • • • • • • • Received $2.4m by way of R&D Tax Incentive Directors provided $2.5m loan funding and the Paddington St Finance debt instrument of $1.3m was extended until the early of September 2019 or the receipt of 2019 R&D Tax Incentive Chinese patent for Biomarkers to monitor disease progression for mesenchymal stem cell (MSC) therapy for inflammatory conditions Received European Patent office notice of intent to grant European Patent for Progenza Cash utilised in operating activities before receipt of the R&D tax incentive is less than $500k per month (FY18: $571k) Strategic review commenced in Q4 2019. Implemented cost containment activities in Q1 2020. Financial review Operating results The Group's operating results for the year was a loss of $6.0 million (FY18: $5.2 million). The increased current year loss is reflective of additional Corporate and Finance costs partially offset by reductions in Research and Development expenditure and the associated impact of a reduced R&D Tax Incentive. Research and development Occupancy Corporate Finance costs Expenses from operations Other expenses Share of loss on investment 2019 $’000 2,433 512 3,922 403 7,270 180 41 2018 $’000 3,957 475 3,462 26 7,920 - 40 Total expenses 7,491 7,960 Movement $’000 (1,524) 37 460 377 (650) 180 1 (469) Research and development expenses Research and development activities include staff and other costs associated with product research, preliminary manufacture and the conduct of clinical trials for the Company’s products. Expenditure for the year was $2.4m (FY18 $4.0m). The continuing reduction in R&D expenditure is a reflection of R&D being predominantly internal and is associated with finalising testing and related activities for Progenza and Sygenus. The costs incurred will enable the Group to capitalise on Progenza’s successful phase 1 clinical trial and initiate phase 2 clinical trials. In line with the Group’s policy and to comply with the accounting standards, all costs associated with research and development are fully expensed in the period in which they Consolidated Financial Statements for the Year Ended 30 June 2019 5 are incurred. The Directors do not consider the Group can demonstrate all the requirements of the accounting standards to capitalise development expenditure. Occupancy costs Occupancy costs of $512k are the direct lease costs of the Pymble corporate ofﬁce and the associated utility costs. They are slightly higher than the prior year which is reflective of the lease expiring and the premises now being leased on a monthly term at a higher rate. Corporate expenses This category of expenditure includes: corporate office employees, Directors, IP, compliance, depreciation and business development costs. In 2019 the expenditure was $3.92 million (FY:18 $3.46 million). The increase in expenditure was driven by a number of one-off expenses including: options expense $100k, provision of $300k against the shareholder loans (pursuant to AASB9 expected credit loss model) and an increase in estimate to costs associated with vacating the premises of $155k. Financial Liabilities of $3.6 million reflects the adoption of AASB 15 and the recognition of the AGC having the opportunity to use US$2.5 million, previously paid to the Company as milestone payments, to subscribe for shares in Regeneus in certain circumstances. This arrangement is more fully detailed in the notes to the Financial Statements. Cash ﬂows The net cash inflows for the period were: Net cash provided by (used in) operating activities Net cash provided by (used in) investing activities Net cash provided by (used in) financing activities Net change in cash and cash equivalents held 2019 $’000 (3,608) (8) 2,780 (836) 2018 $’000 (4,247) (151) 1,354 (3,044) Finance costs Operating activities Finance costs includes Interest expense on the Paddington St Finance Loan and the Directors Loans. Other expenses This expense is the Unrealised foreign exchange loss on financial liability associated with AGC Inc. of Japan US$2.5 million financial liability. Financial Position Significant changes in the Consolidated Statement of Financial Position gave rise to negative net assets. This was particularly the result of increased current liabilities. Other Current Liabilities at $3.8million (FY18: $1.0 million) are the loans provided by Paddington St Finance of $1.3 million and the Directors loans of $2.5 million. Paddington St Finance agreed to extend the repayment of both principal and accrued interest on its R&D loan to the earlier of the end of September 2019 and receipt of the Company’s 2019 R&D Tax Incentive. The drawn down loan of $1.3 million and associated interest should be primarily covered by the tax incentive which is expected to be received Q1 2020. The Directors’ Loans of $2.5 million advanced to the Company in February 2019 is repayable in March 2020 if not converted earlier as part of an equity raising. In August 2019 as part of the equity raising $1.4 million of the Directors Loans was converted to capital in the Company. Cash continued to be managed tightly with the full year cash used in operating activities being $3.6 million (FY18: $4.3 million). Excluding the R&D Tax incentive receipt, the full year cash used in operating activities was $6.0 million (FY18: $6.9 million) reflecting a monthly cash expenditure of less than $500k compared to the prior year’s monthly cash expenditure of in excess of $570k. Investing activities This amount reflects the minor investment in capital equipment required to support the business. Financing activities Cash provided by financing activities includes further net draw-downs from Paddington St Finance of $0.28 million and Directors’ loans provided in February 2019 of $2.50 million. Signiﬁcant changes in state of affairs There were no signiﬁcant changes in the state of affairs of the Group during the reporting period. Changes in accounting policy There were no changes in accounting policy during the reporting period other than the adoption of AASB 9 and AASB 15. Consolidated Financial Statements for the Year Ended 30 June 2019 6 Events subsequent to the reporting period In the period from 30 June 2019 through to the signing of the ﬁnancial report a number of important events have occurred: On 31 July 2019, AGC and Regeneus signed a variation to the joint venture agreements previously entered into, under which the parties acknowledge AGC has the right to terminate the joint venture arrangements and related agreements on the earlier of 31 December 2019 or such other date as may be agreed between the parties. Further, within 120 days of such termination AGC may elect to use US$2,500,000 of upfront and milestone payments previously paid to Regeneus to subscribe for shares in Regeneus at a fixed subscription price of AUD$0.16 per share. Upon such termination, RGS will acquire all of AGC’s shares in the joint venture at a price equal to 50% of the Company’s value as at 31 December 2018. Likely developments, business strategies and prospects FY20 success will be measured by the appointment of a clinical partner in Japan and the implementation of a definitive timetable to commence Phase 2 clinical trials. Activities including ongoing clinical trials of Sygenus and the further development of ‘pain’ applications will continue throughout the year. Corporate Governance Statement The Board is committed to achieving and demonstrating the highest standards of corporate governance. As such, Regeneus Ltd and its controlled entities (the Group) have adopted the third edition of the Corporate Governance Principles and Recommendations which was released by the ASX Corporate Governance Council on 27 March 2014 and became effective for financial years beginning on or after 1 July 2014. On August 1 the Company made a private placement of 29,250,000 shares at 8 cents per share, which raised new capital of $2.34 million. The Company also announced a 1 for 6 rights issue which was partly underwritten by the conversion of $1.4 million of the Directors’ loans and Directors’ subscribing for a further $0.4 million of shares. The Group’s corporate governance statement for the financial year ending 30 June 2019 is dated as at 30 June 2019 and was approved by the Board on 25 September 2019. The corporate governance statement is available on Regeneus’ website at: regeneus.com.au/about/corporate-governance On August 30 the Company announced the results of the non renounceable rights issue. 7,751,973 new shares were issued at 8 cents per share raising a further $620k. Additionally, as part of the underwriting arrangements entered into between the Company and some of its Directors in respect of this rights issue: 1 $1.4 million, previously loaned to the Company by these Directors in February 2019 (and which was repayable in March 2020), has been converted to 17.5 million ordinary shares, to be issued to these participating Directors (or related parties) at 8 cents per share; and an additional $400k has been contributed by some Directors in cash, with 5 million ordinary shares to be issued to these Directors (or related parties) under the rights issue at 8 cents per share. 2 The shortfall following the underwriting is 9,437,872 New Shares (Shortfall Shares). The directors of Regeneus reserve the right, subject to the requirements of the Corporations Act and the ASX Listing Rules, to place any Shortfall Shares within 3 months of the closing date at the Directors’ discretion and at a price not less than the Offer Price. Costs associated with these capital raising are not expected to exceed $300k. On August 13 the Company announced the implementation of strategic focus and cost containment activities. The outcome of these activities is the reduction in recurring operating costs to $250k per month. Further one off cash costs of implementation are expected to be less than $800k. Apart from the above, there are no other matters or circumstances that have arisen since the end of the year that have signiﬁcantly affected or may signiﬁcantly affect either the entity’s operations in future ﬁnancial years, the results of those operations in future ﬁnancial years or the entity’s state of affairs in future ﬁnancial years. Directors’ meetings The number of meetings of Directors (including committees of Directors) held during the year and the number of meetings attended by each Director were as follows: Directors’ name Board meetings Audit and risk committee Remunerations and nominations charter Barry Sechos Leo Lee Graham Vesey Glen Richards John Chiplin1 Alan Dunton2 John Martin3 Roger Aston4 A 11 11 11 11 1 1 10 10 B 11 10 11 10 1 1 9 10 A 2 - - - - - 1 2 B 2 - - - - - 1 2 A - - - - - - - - B - - - - - - - - Column A is the number of meetings the director was entitled to attend Column B is the number of meetings the director did attend. Where a Director joined the Board during the year or resigned their position during the year then the number of meeting entitled to attend is for the relevant period. John Chiplin joined the Board 29 April 2019. 1. Alan Dunton joined the Board 29 April 2019 2. 3. John Martin resigned from the Board 29 April 2019 4. Roger Aston resigned from the Board 29 April 2019 Consolidated Financial Statements for the Year Ended 30 June 2019 7 Dividends paid or recommended No dividends have been paid or declared since the start of the ﬁnancial year (2018: Nil). Unissued shares under option Remuneration report (audited) The Directors of the Group present the Remuneration Report for Executive Directors, Non- executive Directors and other key management personnel prepared in accordance with the Corporations Act 2001 and the Corporations Regulations 2001. Unissued ordinary shares of Regeneus Ltd under option at the date of this report are: The Remuneration Report is set out under the following main headings: Date of granting Expiry date 01/07/2010 21/02/2011 21/10/2014 31/01/2019 31/01/2019 30/06/2020 20/02/2021 20/10/2019 30/01/2024 30/01/2024 Exercise price of option $ 0.136 0.136 0.160 0.200 0.250 Number under option 770,100 1,001,674 900,000 2,500,000 2,500,000 During 2019, 5 million options over ordinary shares were issued subject to shareholder approval (2018: nil). All unexercised, vested options expire on the earlier of their expiry date or within a period set out in the plans. These options were issued under the Employee Share Option Plan and Option Trust Share plans, and have been allotted to individuals on condition that they meet the agreed milestones before the options vest. As part of the IPO, 12,740,252 employee options, that had an exercise price of less than 20 cents, were exercised prior to the listing on 19 September 2013. These were ﬁnanced by a full recourse loan provided by the Company to the option holders. Shares issued during or since the end of the year as a result of exercise of options During or since the end of the year, no shares were issued by the Company as a result of the exercise of options (2018: nil). a. b. c. d. e. f. Principles used to determine the nature and amount of remuneration Details of remuneration Service agreements Share-based remuneration Bonuses and Other information a. Principles used to determine the nature and amount of remuneration The principles of the Group’s executive strategy and supporting incentive programs and frameworks are to: • Align rewards to business outcomes that deliver value to shareholders, • Drive a high performance culture by setting challenging objectives and rewarding high performing individuals, • Ensure remuneration is competitive in the relevant employment market place to support the attraction, motivation and retention of executive talent. Regeneus has structured a remuneration framework that is market competitive and complementary to the reward strategy of the Group. The Board has established a Remuneration and Nominations Committee which operates in accordance with its charter as approved by the Board and is responsible for making recommendations to the Board for reviewing and approving compensation arrangements for the Directors and the Executive team. The remuneration structure that has been adopted by the Group consists of the following components: • • Short and long term incentives, being employee bonuses and options. Fixed remuneration being annual salary, The Remuneration and Nominations Committee assesses the appropriateness of the nature and amount of remuneration on a periodic basis by reference to recent employment market conditions with the overall objective of ensuring maximum stakeholder beneﬁt from the retention of a high quality Board and Executive team. All bonuses, options and incentives are linked to predetermined performance criteria. Consolidated Financial Statements for the Year Ended 30 June 2019 8 Short term incentive (STI) Regeneus performance measures involve the use of annual performance objectives, metrics, and performance appraisals. b. Details of remuneration Details of the nature and amount of each element of key management personnel (KMP) remuneration are shown in the table below: The performance measures are set annually after consultation with the Directors and Executives and are speciﬁcally tailored to the areas where each executive has a level of control. The measures target areas the Board believes hold the greatest potential for expansion and proﬁt and cover ﬁnancial and non-ﬁnancial measures. The KPIs for the Executive team are summarised as follows: Financial - operating results Performance area: • • Non-ﬁnancial - strategic goals set for each individual The Board may, at its discretion, award bonuses for exceptional performance in relation to each person’s pre-agreed KPIs and extraordinary achievements. Voting and comments made at the Company’s last Annual General Meeting Regeneus received 40,474,751 – 93.7% ‘For’ votes on its Remuneration Report for the ﬁnancial year ending 30 June 2018 (2017: 43,796,282 – 98.9% %). The Company received no speciﬁc feedback on its Remuneration Report at the Annual General Meeting. Consequences of performance on shareholder wealth In considering the Group’s performance and beneﬁts for shareholder wealth, the Board has regard to the following indices in respect of the current ﬁnancial year and the previous five (5) ﬁnancial years: Item EPS (cents) Dividends (per share) Net profit (loss) ($000) Share price ($) 2019 2018 2017 2016 2015 (0.029) (0.025) 0.016 (0.017) (0.032) $0 (6,025) $0.085 $0 (5,185) $0.12 $0 3,271 $0.12 $0 $0 (3,574) (6,607) $0.14 $0.15 Executive Directors Short term Incentive $ Other benefits $ Cash salary & fees $ Leo Lee 1 Graham Vesey John Martin 3 2019 174,000 2018 27,500 2019 212,000 2018 212,000 2019 345,011 - - - - - 2018 325,000 250,000 - - 10,396 5,659 (45,275) 7,015 Non-executive Directors Post employ Super- annuation $ - - 20,140 20,140 20,583 30,875 2019 2018 2019 2018 2019 2018 2019 2018 2019 2018 60,000 54,167 55,000 54,167 9,166 - 9,166 - 70,833 84,166 2019 886,512 - - - - - - - - - - - Barry Sechos Glen Richards John Chiplin 2 Alan Dunton 2 Roger Aston 3 Total Total - - - - - - - - - - - - - - - - - - - - Share based payments Total $ Perform- ance related 100,490 274,490 44% - - - - - - - - - - - - - - - 27,500 242,536 237,799 320,319 612,890 60,000 54,167 55,000 54,167 9,166 - 9,166 - 70,833 84,166 0% 0% 0% 0% 41% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 2018 757,000 250,000 12,674 51,015 1,070,689 (34,879) 40,723 100,490 1,041,510 1. 2. 3. Leo Lee joined the Board as a non-executive Director in December 2017 and appointed CEO and executive Director 23 January 2019 John Chiplin and Alan Dunton were appointed as non-executive Directors 29 April 2019 John Martin resigned from the role of CEO 23 January 2019 providing 3 months’ notice and both he and Roger Aston resigned from the Board 29 April 2019 Other beneﬁts include the movement in the annual leave provision and long service leave provision in accordance with AASB 119 Employee Beneﬁts. Where the provision is reduced due to leave taken exceeding leave accrued the movement is negative The share based payment of $100,490 is share based remuneration in the form of options (refer following notes). Consolidated Financial Statements for the Year Ended 30 June 2019 9 The relative proportions of remuneration that are linked to performance and those that are fixed are as follows: Fixed remuneration At risk – STI At risk – options c. Service agreements Remuneration and other terms of employment for the Executive Directors and other key management personnel are formalised in a service agreement. The major provisions of the agreements relating to remuneration are set out below: Name Leo Lee Graham Vesey Barry Sechos Glen Richards John Chiplin Alan Dunton John Martin Roger Aston 56% 100% 100% 100% 100% 100% 100% 100% - - - - - - - - 44% - - - - - - - Name Leo Lee Graham Vesey Barry Sechos Glen Richards John Chiplin Alan Dunton Base salary $ 325,000 212,000 85,000 55,000 55,000 55,000 Term of agreement Notice period Unspecified Unspecified Unspecified Unspecified Unspecified Unspecified 3 months 3 months Nil Nil Nil Nil There are no termination payments provided for in these agreements, other than those required by statute. d. Share-based remuneration Options granted over unissued shares. All options are for ordinary shares in the Company and are exercisable on a one-for-one basis. The options were provided at no cost to the recipients. All options expire on the earlier of their expiry date or within the time period set out in the plan, from termination of the individual’s employment. Details of options over ordinary shares in the Company that were granted as remuneration to each key management personnel are set out below. Name Leo Lee Leo Lee Number granted Grant date 2,500,000 2,500,000 31/01/2019 31/01/2019 Value per option at grant date $ 0.0673 0.0583 Number vested - - Exercise price $ 0.20 0.25 First exercise date Last exercise date 31/01/2020 31/12/2021 31/01/2024 31/01/2024 Options tor Leo Lee require shareholder approval at the AGM. During 2019 4,823,210 (average exercise price $0.25) management personnel options were forfeited (2018: nil) Consolidated Financial Statements for the Year Ended 30 June 2019 10 e. Short term incentives included in remuneration Details of the short-term incentive awarded as remuneration to each key management personnel, the percentage of the available incentive that was paid in the ﬁnancial year, and the percentage that was forfeited because the person did not meet the service and performance criteria is set out below. No part of the incentive is payable in future years. Name Leo Lee Graham Vesey Barry Sechos Glen Richards John Chiplin Alan Dunton John Martin Roger Aston Included in remuneration $ Percentage vested in year Percentage forfeited in year - - - - - - - - - - - - - - - - f. Other information Options held by key management personnel The number of options to acquire shares in the Company held during the 2019 reporting period by each of the key management personnel of the Group, including their related parties are set out below. The 5,000,000 options issued to Leo Lee require shareholder approval at the AGM. Both Graham Vesey and John Martin's options lapsed or expired during the year. Shares held by key management personnel The number of ordinary shares in the Company during the 2019 reporting period held by each of the Group’s key management personnel, including their related parties, are set out below: Name Held at 1 July 2018 Granted as remuneration Purchased Other movement Held at 30 June 2019 - - - - - - - - Leo Lee 1,011,000 Graham Vesey 15,879,968 Barry Sechos 200,000 Glen Richards 2,333,333 John Chiplin Alan Dunton John Martin Roger Aston Totals - - 7,253,908 51,179 26,729,388 - - - - - - - - - - - - - - - - - - - - - - - - (7,253,908) (51,179) 1,011,000 15,879,968 200,000 2,333,333 - - - - (7,253,908) 19,475,480 John Martin resigned as a Director 29 April 2019. Loans to key management personnel These loans relate to the shareholder loan, the terms of which are disclosed in Note 13. Name Balance at 1 July 2018 Granted Other changes Balance at end of year Leo Lee Graham Vesey Barry Sechos Glen Richards John Chiplin Alan Dunton 2,142,855 - - - - John Martin 2,680,355 Roger Aston - - 5,000,000 - 5,000,000 - - - - - - - (2,142,855) - - - - (2,680,355) - - - - - - - - Totals 4,823,210 5,000,000 176,790 5,000,000 Vested and exercisabl e at 30 June 2019 - Vested, un- exercisabl e at 30 June 2019 5,000,000 Name John Martin Graham Vesey Totals Loan at 1 July 2018 295,925 150,552 446,477 Loans repaid - - - Loans Advanced - Other movement (295,925) Loan at 30 June 2019 - - - - (295,925) 150,552 150,552 John Martin resigned as a Director 29 April 2019. The loan to John Martin of $295,925 remains payable as at 30 June 2019. - - - - - - - - - - - - - - - 5,000,000 Consolidated Financial Statements for the Year Ended 30 June 2019 11 Loans by key management personnel These loans are either the R&D loan facility provided by Paddington St Finance Pty Ltd or the loans provided by the Directors in February 2019. These loans are further detailed in note 28. Name Loan at 1 July 2018 Loans Advanced Loans Repaid Others Repaid Loan at 30 June 2019 Barry Sechos (Paddington St Finance) Barry Sechos (Other) Leo Lee Glen Richards John Martin 1,000,000 2,160,000 1,880,000 - - - - 250,000 2,100,000 100,000 50,000 - - - - - - - - 1,280,000 250,000 2,100,000 100,000 (50,000) - Totals 1,000,000 4,660,000 1,880,000 (50,000) 3,730,000 John Martin resigned as a Director 29 April 2019. This loan from John Martin of $50,000 remains outstanding at 30 June 2019 and is subject to the original loan agreement. End of audited remuneration report. Consolidated Financial Statements for the Year Ended 30 June 2019 12 Environmental legislation Regeneus’ operations are not subject to any particular or signiﬁcant environmental regulation under a law of the Commonwealth or of a State or Territory in Australia. Indemnities given to auditors and officers and insurance premiums paid During the year, Regeneus paid a premium to insure ofﬁcers of the Group. The ofﬁcers of the Group covered by the insurance policy include all Directors. The liabilities insured are legal costs that may be incurred in defending civil or criminal proceedings that may be brought against the ofﬁcers in their capacity as ofﬁcers of the Group, and any other payments arising from liabilities incurred by the ofﬁcers in connection with such proceedings, other than where such liabilities arise out of conduct involving a wilful breach of duty by the ofﬁcers or the improper use by the ofﬁcers of their position or of information to gain advantage for themselves or someone else to cause detriment to the Group. Details of the amount of the premium paid in respect of the insurance policies is not disclosed as such disclosure is prohibited under the terms of the contract. The Group has not otherwise, during or since the end of the ﬁnancial year, except to the extent permitted by law, indemniﬁed or agreed to indemnify any current or former ofﬁcer or auditor of the Group against a liability incurred as such by an ofﬁcer or auditor. Non-audit services From time to time, Grant Thornton, the Group’s auditors, perform certain other services in addition to their statutory audit duties. The Board considers any non-audit services provided during the year by the auditor and satisﬁes itself that the provision of these non- audit services during the year is compatible with, and does not compromise, the auditor independence requirements of the Corporations Act 2001. Details of the amounts paid to the auditors of the Group, Grant Thornton Audit Pty Ltd, and its related practices for audit and non-audit services provided during the year are set out in Note 25 to the Financial Statements. Proceedings on behalf of the Group No person has applied to the Court under section 237 of the Corporations Act 2001 for leave to bring proceedings on behalf of the Group, or to intervene in any proceedings to which the Group is a party, for the purpose of taking responsibility on behalf of the Group for all or part of those proceedings. Auditor’s independence declaration A copy of the Auditor’s independence declaration as required under section 307C of the Corporations Act 2001 is set out on page 14 and forms part of this Directors’ report. Signed in accordance with a resolution of the Board of Directors: Leo Lee CEO and Executive Director Dated this day 25th September 2019 Consolidated Financial Statements for the Year Ended 30 June 2019 13 Auditor’s independence declaration 14 Consolidated statement of profit or loss and other comprehensive income For the year ended 30 June Revenue Other income Research and development expenses Occupancy expenses Corporate expenses Finance costs Share of loss on investments accounted for using equity method Unrealised foreign exchange loss on contract liability Profit/(loss) before income tax Income tax (expense) / benefit Profit/(loss) for the year Other comprehensive (expense) / income Note 6 6 7b 15 24 2019 $ 2018 $ 25,077 610,511 1,441,782 2,164,595 (2,432,564) (3,956,639) (512,311) (474,939) (3,922,731) (3,462,416) (402,800) (40,903) (180,150) (25,862) (39,850) - (6,024,600) (5,184,600) - - (6,024,600) (5,184,600) - - Total comprehensive profit/(loss) for the year (6,024,600) (5,184,600) Earnings per share Basic earnings per share Earnings per share from continuing operations Diluted earnings per share Earnings per share from continuing operations 26 26 (0.029) (0.025) (0.029) (0.025) Consolidated Financial Statements for the Year Ended 30 June 2019 15 Consolidated statement of financial position As at 30 June Current Assets Cash and cash equivalents Inventories R&D incentive receivable Other current assets Financial assets at amortised cost Total current assets Non-current assets Property, plant and equipment Intangible assets Investments accounted for using the equity method Other non-current assets Total non-current assets Total assets Current liabilities Trade and other payables Provisions Borrowings Financial liabilities Total current liabilities Non-current liabilities Provisions Total non-current liabilities Total liabilities Net assets Equity Issued capital Accumulated losses Reserves Total equity Note 2019 $ 2018 $ 8 9 10 11 12 13 14 15 16 17 18 19 20 18 255,463 8,615 1,249,440 257,016 596,157 1,091,579 15,336 2,164,595 145,307 896,157 2,384,691 4,312,974 153,448 - 3,675 - 157,123 2,541,814 1,055,946 352,677 3,780,000 3,564,300 8,752,923 175,386 175,386 8,928,309 (6,386,495) 417,248 1,644 41,263 210,000 670,155 4,983,129 707,209 111,398 1,000,000 - 1,818,607 242,757 242,757 2,061,364 2,921,765 21.1 31,076,819 31,076,819 (37,875,379) (29,774,504) 21.2 412,065 (6,386,495) 1,619,450 2,921,765 Consolidated Financial Statements for the Year Ended 30 June 2019 16 Consolidated statement of changes in equity For the year ended 30 June Balance at 1 July 2017 Reported loss for the year Reported other comprehensive income (expense) Employee share-based payment option expense Transfer from reserves to retained earnings for options forfeited Share capital $ Share option reserve $ Retained earnings $ Total attributable to parent owners $ Total equity $ 31,076,819 1,652,773 (24,629,684) 8,099,908 8,099,908 - - - - - - 6,457 (5,184,600) (5,184,600) (5,184,600) - - - - 6,457 6,457 (39,780) 39,780 - - Balance at 30 June 2018 Balance at 1 July 2018 31,076,819 1,619,450 (29,774,504) 2,921,765 2,921,765 31,076,819 1,619,450 (29,774,504) 2,921,765 2,921,765 Restatement for adoption of accounting standard AASB 15 - - (3,384,150) (3,384,150) (3,384,150) Restated balance at 1 July 2018 31,076,819 1,619,450 (33,158,654) (462,385) (462,385) Reported loss for the year Reported other comprehensive income (expense) Employee share-based payment option expense Transfer from reserves to retained earnings for options forfeited - - - - - - 100,490 (6,024,600) (6,024,600) (6,024,600) - - - - 100,490 100,490 (1,307,875) 1,307,875 - - Balance at 30 June 2019 31,076,819 412,065 (37,875,379) (6,386,495) (6,386,495) Consolidated Financial Statements for the Year Ended 30 June 2019 17 Consolidated statement of cash flows For the year ended 30 June Operating activities Receipts from customers Note 2019 $ 2018 $ - 616,216 Payments to suppliers and employees (5,866,152) (7,458,867) Interest received Grant Received R&D incentive refund Finance costs 19,077 6,000 13,250 - 2,356,937 2,608,223 (124,358) (25,862) Net cash provided by / (used in) operating activities 27 (3,608,496) (4,247,040) Investing activities Purchase of property, plant and equipment Net cash (used in) by investing activities Financing activities Proceeds from related party loan Repayment of related party loan Receipts from shareholder loan Net cash provided by financing activities Net change in cash and cash equivalents held (7,620) (150,966) (7,620) (150,966) 4,660,000 1,000,000 (1,880,000) - - 354,449 2,780,000 1,354,449 (836,116) (3,043,557) Cash and cash equivalents at beginning of financial year 1,091,579 4,135,136 Cash and cash equivalents at end of financial year 9 255,463 1,091,579 Note: This statement should be read in conjunction with the notes to the financial statements. Consolidated Financial Statements for the Year Ended 30 June 2019 18 Notes to the consolidated financial statements 1. Nature of operations Regeneus is a Sydney based ASX listed clinical stage regenerative medicine company that develops innovative cell- based therapies for human and animal health markets, with a focus on osteoarthritis and musculoskeletal disorders as well as oncology and dermatology diseases. The portfolio of therapeutic products is being developed using the Company’s proprietary stem cell and immuno-oncology technology platforms. Regenerative medicine is a rapidly growing multidisciplinary specialty that is focused on the repair or regeneration of cells, tissues and organs. The primary goal is to enhance the body’s natural ability to replace tissue damaged or destroyed by injury or disease. Where commercial opportunities are identiﬁed, the Group seeks to license appropriate parties. 2. General information and statement of compliance The ﬁnancial report is a general purpose ﬁnancial report that has been prepared in accordance with Australian Accounting Standards (including Australian Accounting Interpretations), other authoritative pronouncements of the Australian Accounting Standards Board and the Corporations Act 2001. Regeneus is a for-proﬁt entity for the purpose of preparing the ﬁnancial statements. The ﬁnancial statements cover Regeneus and its controlled entities as a consolidated entity (the Group). As at 30 June 2019, Regeneus is a Public Group, incorporated and domiciled in Australia. The address of its registered ofﬁce and its principal place of business is 25 Bridge St., Pymble, NSW 2073, Australia. Statement of compliance Compliance with Australian Accounting Standards ensures that the ﬁnancial statements and notes of Regeneus comply with International Financial Reporting Standards (IFRS) as issued by the IASB. The consolidated ﬁnancial statements for the year ended 30 June 2019 were approved and authorised for issue by the Board of Directors on 25 September 2019. Basis of preparation The ﬁnancial statements have been prepared on an accruals basis and are based on historical costs modiﬁed by the revaluation of selected non-current assets and ﬁnancial instruments for which the fair value basis of accounting has been applied. New and revised standards that are effective for these ﬁnancial statements A number of new and revised standards became effective for the first time to annual periods beginning on or after 1 July 2018. Information on the more significant standard(s) is presented below: AASB 9: Financial instruments This standard replaces AASB 139 Financial Instruments: Recognition and Measurement. AASB 9 includes revised guidance on the classification and measurement of financial instruments, including a new expected credit loss model for calculation of impairment on financial assets, and new general hedge accounting requirements. It also carries forward guidance on recognition and derecognition of financial instruments from AASB 139. When adopting AASB 9, the Group has applied transitional relief and elected not to restate prior periods. Rather, differences arising from the adoption of AASB 9 in relation to classification, measurement, and impairment are recognised in opening retained earnings as at 1 July 2018. Consolidated Financial Statements for the Year Ended 30 June 2019 19 On adoption of AASB 9, the Group has changed the accounting for impairment losses for financial assets and contract assets by replacing AASB 139’s incurred loss approach with a forward- looking expected credit loss (ECL) approach, and has calculated ECLs based on the Group’s historical credit loss experience, adjusted for forward- looking factors specific to the debtors and the economic environment. No adjustment was raised upon initial adoption. In addition, the adoption of AASB 9 has affected the classification of financial assets including the loans to shareholders of $936,956 being reclassified on 1 July 2018 from other current assets into financial assets held at amortised cost. There is no change to the underlying accounting as ‘amortised cost’ applied under AASB 139 continue to apply under AASB 9. Reconciliation of financial instruments on adoption of AASB 9 On the date of initial application, 1 July 2018, the financial instruments of the Group were reclassified as follows: Measurement Category Carrying Amounts Original AASB 139 category New AASB 9 category Notes Closing balance 30 June 2018 AASB 139 $ Adoption of AASB 9 $ Opening Balance 1 July 2018 AASB 9 $ Loans and receivables Loans and receivables Held to maturity Amortised cost Amortised cost Amortised cost Amortised cost Amortised cost Amortised cost Amortised cost 8 12 17 19 - 1,091,579 896,157 1,987,736 638,235 1,000,000 1,638,235 - - - - - - - 1,091,579 896,157 1,987,736 638,235 1,000,000 1,638,235 Current financial assets Trade and other receivables Cash and cash equivalents Shareholder loan Total financial assets Current financial liabilities Trade and other payables Related party loans Total financial liabilities Consolidated Financial Statements for the Year Ended 30 June 2019 20 Financial assets are measured at amortised cost if the assets meet the following conditions (and are not designated as FVPL): • • they are held within a business model whose objective is to hold the financial assets and collect its contractual cash flows the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is omitted where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most other receivables fall into this category of financial instruments as well as loans to shareholders that were previously classified as held to-maturity under AASB 139. AASB 15: Revenue from Contracts with Customers AASB 15 establishes a comprehensive framework for determining whether, how much, and when revenue is recognised. It replaced AASB 118 Revenue and AASB 111 Construction Contracts and related interpretations. The Group has adopted AASB 15 from 1 July 2018 which resulted in changes in accounting policies, and an adjustment recognised in the half-year consolidated financial statements. In accordance with the transition provisions of AASB 15, the Group has adopted the modified retrospective transition approach, where any adjustment to historical revenue transactions (that impacts net profit) would be recorded against opening retained earnings as at 1 July 2018 and comparatives are not restated. The Group undertook a detailed review of its revenue contracts that were entered into during the transition period and concluded that an adjustment relating to the AGC Manufacturing Licence of $3,384,150 (representing US$2.5m translated at the spot rate on the date of transition) was required to the opening balances as a result of AASB 15 having a higher threshold in respect of constrained revenue than AASB 118. For licence revenue, and in order to determine whether to recognise revenue, the Group follows a 5-step process: 1. 2. Identifying the contract with a customer, Identifying the performance obligations, 3. Determining the transaction price, 4. Allocating the transaction price to the performance obligations, 5. Recognising revenue when/as performance obligation(s) are satisfied. The Group will enter into licence transactions and receive upfront and milestone payments as part of research and development collaborations or out- licensing agreements. The total transaction price for a contract is allocated amongst the various performance obligations based on their relative stand-alone selling prices using the residual method and cost method. Revenue is recognised either at a point in time or over time, when (or as) the Group satisfies performance obligations by transferring the promised goods or services to its customers. The Group recognises contract liabilities for consideration received in respect of unsatisfied performance obligations or where revenue is constrained and reports these amounts as contract liabilities in the statement of financial position. Similarly, if the Group satisfies a performance obligation before it receives the consideration, the Group recognises either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due. Licence revenue is determined with reference to performance obligations to provide either patents or IP. Licence revenues are considered a right to use and recognised at a point in time, net of any revenue constraints. All revenue is licence revenue. The assessment of the criteria for income recognition and the determination of the appropriate period during which income is recognised are subject to judgement where variable consideration that is constrained and revenue is recognised only when it is highly probable that there will not be a significant reversal of revenue. The adjustment resulted in an increase in contract liability on initial recognition as follows: Impact Area Current liabilities Other equity $ Retained earnings $ - 3,384,150 Total equity $ 3,384,150 The tables below highlight the impact of AASB 15 on the Group’s statement of financial position for the year ending 30 June 2019. The adoption of AASB 15 did not have a material impact on the Group’s statement of profit or loss and other comprehensive income and the statement of cash flows. Statement of financial position (extract) Current liabilities Contract liabilities Equity Amounts under AASB 118 & 111 $ Adjustments $ Amounts under AASB 15 $ (3,384,150) (3,384,150) Retained earnings (29,774,504) (3,384,150) (33,158,654) Consolidated Financial Statements for the Year Ended 30 June 2019 21 Accounting standards issued but not yet effective and not adopted early by the Group At the date of authorisation of these ﬁnancial statements, certain new standards, amendments and interpretations to existing standards have been published but are not yet effective, and have not been adopted early by the Group. Management anticipates that all of the relevant pronouncements will be adopted in the Group’s accounting policies for the ﬁrst period beginning after the effective date of the pronouncement. Information on new standards, amendments and interpretations that are expected to be relevant to the Group’s ﬁnancial statements is provided below. Certain other new standards and interpretations have been issued but are not expected to have a material impact on the Group’s ﬁnancial statements. AASB 16 Leases AASB 16: • Replaces AASB 117 Leases and some lease-related interpretations • Requires all leases to be accounted for ‘on-balance sheet’ be lessees, other than short-term and low value asset leases • Provides new guidance on the application of the deﬁnition of lease and on sale and lease back accounting • Largely retains the existing lessor accounting requirements in AASB 117 • Requires new and different disclosures about leases. Based on the Groups assessment and that the Group currently has no material leases, it is expected that the first-time adoption of AASB 16 for the year ending 30 June 2020 will not have a material impact on the transactions and balances recognised in the financial statements. 3. Summary of accounting policies Overall considerations The signiﬁcant accounting policies that have been used in the preparation of these consolidated ﬁnancial statements are summarised below. The consolidated ﬁnancial statements have been prepared using the measurement bases speciﬁed by the Australian Accounting Standards for each type of asset, liability, income and expense. The measurement bases are more fully described in the following accounting policies. a. Basis of consolidation Controlled entities The Group financial statements consolidate those of the Parent Company and all of its subsidiaries as of 30 June 2019. The parent controls a subsidiary if it is exposed, or has rights, to variable returns from its involvement with the subsidiary and has the ability to affect those returns through its power over the subsidiary. All subsidiaries have a reporting date of 30 June. All transactions and balances between Group companies are eliminated on consolidation, including unrealised gains and losses on transactions between Group companies. Where unrealised losses on intra-group asset sales are reversed on consolidation, the underlying asset is also tested for impairment from a group perspective. Amounts reported in the financial statements of subsidiaries have been adjusted where necessary to ensure consistency with the accounting policies adopted by the Group. Profit or loss and other comprehensive income of subsidiaries acquired or disposed of during the year are recognised from the effective date of acquisition, or up to the effective date of disposal, as applicable. Non-controlling interests, presented as part of equity, represent the portion of a subsidiary’s profit or loss and net assets that is not held by the Group. The Group attributes total comprehensive income or loss of subsidiaries between the owners of the parent and the non-controlling interests based on their respective ownership interests. Investments in associates and joint arrangements Associates are those entities over which the Group is able to exert significant influence but which are not subsidiaries. A joint venture is an arrangement that the Group controls jointly with one or more other investors, and over which the Group has rights to a share of the arrangement’s net assets rather than direct rights to underlying assets and obligations for underlying liabilities. A joint arrangement in which the Group has direct rights to underlying assets and obligations for underlying liabilities is classified as a joint operation. Investments in all joint ventures are accounted for using the equity method. Interests in joint operations are accounted for by recognising the Group’s assets (including its share of any assets held jointly), its liabilities (including its share of any liabilities incurred jointly), its revenue (including its share of the revenue from the sale of output by the joint operation), and its expenses (including its share of any expenses incurred jointly). These are incorporated in the financial statements under the appropriate headings. Any goodwill or fair value adjustment attributable to the Group’s share in the associate or joint venture is not recognised separately and is included in the amount recognised as investment. The carrying amount of the investment in associates and joint ventures is increased or decreased to recognize the Group’s share of the profit or loss and other comprehensive income of the associate and joint venture, adjusted where necessary to ensure consistency with the accounting policies of the Group. Consolidated Financial Statements for the Year Ended 30 June 2019 22 Unrealised gains and losses on transactions between the Group and its associates and joint ventures are eliminated to the extent of the Group’s interest in those entities. Where unrealised losses are eliminated, the underlying asset is also tested for impairment. If an entity’s share of losses of an associate or a joint venture equals or exceeds its interest in the associate or joint venture, the entity discontinues recognising its share of further losses The interest in an associate or a joint venture is the carrying amount of the investment in the associate or joint venture determined using the equity method together with any long-term interests that, in substance, form part of the entity’s net investment in the associate or joint venture. For example, an item for which settlement is neither planned nor likely to occur in the foreseeable future is, in substance, an extension of the entity’s investment in that associate or joint venture. Such items may include preference shares and long-term receivables or loans, but do not include trade receivables, trade payables or any long-term receivable for which adequate collateral exists, such as secured loans. Losses recognised using the equity method in excess of the entity’s investment in ordinary shares are applied to the other components of the entity’s interest in an associate or a joint venture in the reverse order of their seniority (ie priority in liquidation). After the entity’s interest is reduced to zero, additional losses are provided for, and a liability is recognised, only to the extent that the entity has incurred legal or constructive obligations or made payments on behalf of the associate or joint venture. If the associate or joint venture subsequently reports profits, the entity resumes recognising its share of those profits only after its share of the profits equals the share of losses not recognised. b. Segment reporting Operating segments are presented using the ‘management approach’, where the information presented is on the same basis as the internal reports provided to the Chief Operating Decision Makers (CODM). The CODM is responsible for the allocation of resources to operating segments and assessing their performance. The Group’s operating segment is based on the internal reports that are reviewed and used by the Board of Directors (being the CODM) in assessing performance and determining the allocation of resources. Reports provided to the CODM reference the Group operating in one segment, being the development of innovative cell-based therapies to address signiﬁcant unmet medical needs in human and veterinary health. Initial focus is osteoarthritis and other musculoskeletal disease as well as oncology and dermatology. The information reported to the CODM, on a monthly basis, is proﬁt or loss before tax, assets and liabilities and cash flow. c. Going concern basis of accounting The Group incurred a loss after income tax of $6,024,600 for the year ended 30 June 2019 (2018: $5,184,600), had net cash outflows from operating activities of $3,608,496 (2018: $4,247,040) and as at 30 June 2018 has accumulated losses of $37,875,379 (2018: $29,774,504). The cash balance at 30 June was $255,463. The Directors have prepared the ﬁnancial statements on a going concern basis which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As at 30 June 2019 Regeneus had net liabilities of $6,386,495 (2018: $2,921,765 positive net assets). During August 2019, as referred to in the subsequent event (Note 35) $3.36 million was raised through the issue of equity. This was through a private placement of $2.34 million, including $1.4m of converted Director Loans, a rights issue of $0.62 million, and an additional Directors subscription of $0.40 million. Costs associated with the capital raisings are expected to be approximately $0.3 million. The funds raised have been used to pay creditors, accruals and restructuring costs. The restructuring completed subsequent to year end cost $0.8 million and has reduced cash burn to approximately $250k per month. The Group will need to find additional sources of funding in order to continue as a going concern. The Company continues to engage with brokers and other third parties to seek to place the rights issue shortfall of circa $750k before costs. The Directors are continuing to engage in discussions to enter into a clinical development and commercialisation licence with a Japanese partner. The discussions are positive and the Directors are expecting that formal agreement of terms will be achieved before the end of the calendar year 2019. If signed, it is expected that the licence arrangement will provide upfront funding and future payments contributing to the Group’s funding requirements for the next 18 months. In addition to this, the Directors continue to have a number of additional strategies available to maintain the Group in a positive cash flow position. These strategies include the availability of loan funding including the potential extension or replacement of the R&D loan, further product licensing or raising additional capital, including issuance of securities or further cost reduction strategies. Should the above transactions or funding options not materialise, there is material uncertainty whether the consolidated entity will continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in these ﬁnancial statements. Consolidated Financial Statements for the Year Ended 30 June 2019 23 d. Comparative ﬁgures When required by accounting standards, comparative ﬁgures have been adjusted to conform to changes in the presentation for the current ﬁnancial year. e. Cash and cash equivalents Cash comprises cash on hand and demand deposits. Cash equivalents are short-term, highly liquid investments that are readily convertible to known amounts of cash and which are subject to an insigniﬁcant risk of changes in value. f. Income tax The income tax expense (revenue) for the year comprises current income tax expense (income) and deferred tax expense (income). Current and deferred income tax expense (income) is charged or credited directly to other comprehensive income instead of the proﬁt or loss when the tax relates to items that are credited or charged directly to other comprehensive income. Tax expense recognised in proﬁt or loss comprises the sum of deferred tax and current tax not recognised in other comprehensive income or directly in equity. Current income tax assets and/or liabilities comprise those obligations to, or claims from, the Australian Taxation Ofﬁce (ATO) and other ﬁscal authorities relating to the current or prior reporting periods, that are unpaid at the reporting date. Calculation of current tax is based on tax rates and tax laws that have been enacted or substantively enacted by the end of the reporting period. Deferred income taxes are calculated using the liability method on temporary differences between the carrying amounts of assets and liabilities and their tax bases. However, deferred tax is not provided on the initial recognition of goodwill or on the initial recognition of an asset or liability unless the related transaction is a business combination or affects tax or accounting proﬁt. Deferred tax on temporary differences associated with investments in subsidiaries and joint ventures is not provided if reversal of these temporary differences can be controlled by the Group and it is probable that reversal will not occur in the foreseeable future. Deferred tax assets and liabilities are calculated, without discounting, at tax rates that are expected to apply to their respective period of realisation, provided they are enacted or substantively enacted by the end of the reporting period. Deferred tax assets are recognised to the extent that it is probable that they will be able to be utilised against future taxable income, based on the Group’s forecast of future operating results which is adjusted for signiﬁcant non-taxable income and expenses and speciﬁc limits to the use of any unused tax loss or credit. Deferred tax liabilities are always provided for in full. Deferred tax assets and liabilities are offset only when the Group has a right and intention to set off current tax assets and liabilities from the same taxation authority. Changes in deferred tax assets or liabilities are recognised as a component of tax income or expense in proﬁt or loss, except where they relate to items that are recognised in other comprehensive income (such as the revaluation of land) or directly in equity, in which case the related deferred tax is also recognised in other comprehensive income or equity, respectively. g. Inventories Inventories are measured at the lower of cost and net realisable value. The average cost method has been used to value inventory. Net realisable value represents the estimated selling price for inventories less all estimated costs of completion and costs necessary to make the sale. h. Plant and equipment Each class of property, plant and equipment is carried at cost less, where applicable, any accumulated depreciation and impairment losses. Subsequent costs are included in the asset’s carrying amount or recognised as a separate asset, as appropriate, only when it is probable that future economic beneﬁts associated with the item will flow to the Group and the cost of the item can be measured reliably. All other repairs and maintenance are charged to the statement of proﬁt or loss and other comprehensive income during the ﬁnancial period in which they are incurred. i. Depreciation The depreciable amount of ﬁxed assets are depreciated on a straight line over their useful lives to the Consolidated entity commencing from the time the asset is held ready for use. Leased assets are depreciated over the shorter of either the unexpired period of the lease or the estimated useful lives of the assets. The depreciation rates generally used for each class of depreciable assets are: Class of fixed asset Office equipment straight line Laboratory equipment straight line Office fit-out straight line Leasehold improvements straight line Depreciation rate (%) 25%-50% 20%-30% Life of lease 20% The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each reporting period date. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount. Gains and losses on disposals are determined by comparing proceeds with the carrying amount. These gains or losses are included in the statement of proﬁt or loss and other comprehensive income. j. Intangibles Intangible assets include acquired software. Intangible assets are accounted for using the cost model whereby capitalised costs are amortised on a reducing balance basis over their estimated useful lives, as these assets are considered ﬁnite. Amortisation commences from the date the asset is brought into use. Acquired computer software licences are capitalised on the basis of the costs incurred to acquire Consolidated Financial Statements for the Year Ended 30 June 2019 24 and install the speciﬁc software. Subsequent expenditure is expensed as incurred. Costs associated with maintaining intangibles are expensed as incurred. The amortisation rate used for acquired software is 25% straight line. The Group has reviewed its policy not to capitalise development costs unless they meet the criteria as set in AASB 138. All development costs not meeting the recognition criteria of AASB 138 are expensed. k. Impairment of non-ﬁnancial assets At each reporting date, the Group reviews the carrying amounts of its tangible and intangible assets to determine whether there is any indication that the assets may be impaired. If any such indication exists, or when annual impairment testing for an asset is required (i.e. intangible assets with indeﬁnite useful lives and intangible assets not yet available for use), the Group makes an estimate of the asset’s recoverable amount. An asset’s recoverable amount is the higher of its fair value less costs to sell and its value in use and is determined for an individual asset, unless the asset does not generate cash inflows that are largely independent of those from other assets or groups of assets and the asset’s value in use cannot be estimated to be close to its fair value. In such cases the asset is tested for impairment as part of the cash generating unit to which it belongs. When the carrying amount of an asset or cash-generating unit exceeds its recoverable amount, the asset or cash- generating unit is considered impaired and is written down to its recoverable amount. To determine the value-in-use, management estimates expected future cash flows from each asset or cash- generating unit and determines a suitable interest rate in order to calculate the present value of those cash flows. The data used for impairment testing procedures are directly linked to the Group’s latest approved budget, adjusted as necessary to exclude the effects of future reorganisations and asset enhancements. Discount factors are determined individually for each asset or cash-generating unit and reflect management’s assessment of respective risk proﬁles, such as market and asset- speciﬁc risks factors. Impairment losses relating to continuing operations are recognised in those expense categories consistent with the function of the impaired asset unless the asset is carried at revalued amount (in which case the impairment loss is treated as a revaluation decrease). l. Leases Leases of ﬁxed assets where substantially all the risks and beneﬁts incidental to the ownership of the asset, but not the legal ownership, are transferred to entities in the Group are classiﬁed as ﬁnance leases. Finance leases are capitalised by recording an asset and a liability at the lower of the amounts equal to the fair value of the leased property or the present value of the minimum lease payments, including any guaranteed residual values. Lease payments are allocated between the reduction of the lease liability and the lease interest expense for the period. Leased assets are depreciated on a straight-line basis over the shorter of their estimated useful lives or the lease term. Lease payments for operating leases, where substantially all the risks and beneﬁts remain with the lessor, are charged as expenses in the periods in which they are incurred. Lease incentives under operating leases are recognised as a liability and amortised on a straight-line basis over the life of the lease term. m. Foreign currency transactions and balances Functional and presentation currency The functional currency of each entity is measured using the currency of the primary economic environment in which that entity operates. The consolidated ﬁnancial statements are presented in Australian dollars which is the consolidated entity’s functional and presentation currency. Transaction and balances Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the year end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non- monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined. Exchange differences arising on the translation of monetary items are recognised in the statement of proﬁt or loss and other comprehensive income. n. Financial instruments Financial assets and ﬁnancial liabilities are recognised when the Group becomes a party to the contractual provisions of the ﬁnancial instrument, and are measured initially at fair value adjusted by transactions costs, except for those carried at fair value through profit or loss, which are measured initially at fair value. Subsequent measurement of financial assets and financial liabilities are described below. Financial assets are de-recognised when the contractual rights to the cash flows from the ﬁnancial asset expire, or when the ﬁnancial asset and all substantial risks and rewards are transferred. A ﬁnancial liability is de-recognised when it is extinguished, discharged, cancelled or expires. Classification and subsequent measurement of financial assets Except for those trade receivables that do not contain a significant financing component and are measured at the transaction price in accordance with AASB 15, all financial assets are initially measured at fair value adjusted for transaction costs (where applicable). For the purpose of subsequent measurement, financial assets other than those designated and effective as hedging instruments are classified into Consolidated Financial Statements for the Year Ended 30 June 2019 25 the following categories upon initial recognition: • amortised cost • fair value through profit or loss (FVPL) • equity instruments at fair value through other comprehensive income (FVOCI) • debt instruments at fair value through other comprehensive income (FVOCI) All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs, finance income or other financial items, except for impairment of trade receivables which is presented within other expenses. Classifications are determined by both: • The entities business model for managing the financial asset • The contractual cash flow characteristics of the financial assets All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs, finance income or other financial items, except for impairment of trade receivables, which is presented within other expenses. Subsequent measurement financial assets Financial assets at amortised cost Financial assets are measured at amortised cost if the assets meet the following conditions (and are not designated as FVPL): • they are held within a business model whose objective is to hold the • financial assets and collect its contractual cash flows the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is omitted where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most other receivables fall into this category of financial instruments as well as government bonds that were previously classified as held-to-maturity under AASB 139. Financial assets at fair value through profit or loss (FVPL) Financial assets that are held within a different business model other than ‘hold to collect’ or ‘hold to collect and sell’ are categorised at fair value through profit and loss. Further, irrespective of business model financial assets whose contractual cash flows are not solely payments of principal and interest are accounted for at FVPL. All derivative financial instruments fall into this category, except for those designated and effective as hedging instruments, for which the hedge accounting requirements apply (see below). Equity instruments at fair value through other comprehensive income (Equity FVOCI) Investments in equity instruments that are not held for trading are eligible for an irrevocable election at inception to be measured at FVOCI. Under Equity FVOCI, subsequent movements in fair value are recognised in other comprehensive income and are never reclassified to profit or loss. Dividend from these investments continue to be recorded as other income within the profit or loss unless the dividend clearly represents return of capital. Debt instruments at fair value through other comprehensive income (Debt FVOCI) Financial assets with contractual cash flows representing solely payments of principal and interest and held within a business model of collecting the contractual cash flows and selling the assets are accounted for at debt FVOCI. Any gains or losses recognised in OCI will be reclassified to profit or loss upon derecognition of the asset. Impairment of Financial assets AASB 9’s impairment requirements use more forward looking information to recognize expected credit losses – the ‘expected credit losses (ECL) model’. Instruments within the scope of the new requirements included loans and other debt-type financial assets measured at amortised cost and FVOCI, trade receivables, contract assets recognised and measured under AASB 15 and loan commitments and some financial guarantee contracts (for the issuer) that are not measured at fair value through profit or loss. The Group considers a broader range of information when assessing credit risk and measuring expected credit losses, including past events, current conditions, reasonable and supportable forecasts that affect the expected collectability of the future cash flows of the instrument. In applying this forward-looking approach, a distinction is made between: • financial instruments that have not deteriorated significantly in credit quality since initial recognition or that have low credit risk (‘Stage 1’) and • financial instruments that have deteriorated significantly in credit quality since initial recognition and whose credit risk is not low (‘Stage 2’). ‘Stage 3’ would cover financial assets that have objective evidence of impairment at the reporting date. ‘12-month expected credit losses’ are recognised for the first category while ‘lifetime expected credit losses’ are recognised for the second category. Measurement of the expected credit losses is determined by a probability- weighted estimate of credit losses over the expected life of the financial instrument. Trade and other receivables and contract assets The Group makes use of a simplified approach in accounting for trade and other receivables as well as contract assets and records the loss allowance at the amount equal to the expected lifetime credit losses. In using this practical expedient, the Group uses its historical experience, external indicators and forward-looking information to calculate the expected credit losses using a provision matrix. The Group assess impairment of trade receivables on a collective basis as they possess Consolidated Financial Statements for the Year Ended 30 June 2019 26 credit risk characteristics based on the days past due. The Group makes no allowance for amounts less than 90 days past due and writes off fully any amounts that are more than 90 days past due. Classification and measurement of financial liabilities As the accounting for financial liabilities remains largely unchanged from AASB 139, the Group’s financial liabilities were not impacted by the adoption of AASB 9. However, for completeness, the accounting policy is disclosed below. The Group’s financial liabilities include borrowings, and trade and other payables. Financial liabilities are initially measured at fair value, and, where applicable, adjusted for transaction costs unless the Group designated a financial liability at fair value through profit or loss. Subsequently, financial liabilities are measured at amortised cost using the effective interest method except for derivatives and financial liabilities designated at FVPL, which are carried subsequently at fair value with gains or losses recognised in profit or loss (other than derivative financial instruments that are designated and effective as hedging instruments). All interest-related charges and, if applicable, changes in an instrument’s fair value that are reported in profit or loss are included within finance costs or finance income. Accounting policies applicable to comparative period (30 June 2018) where the effect of discounting is immaterial. market transactions or using a valuation technique where no active market exists. Classification and subsequent measurement of financial assets Until 30 June 2018, the Group classified its financial assets in the following categories: • • loans and receivables financial assets at fair value through profit or loss (FVPL) • Held-to-maturity (HTM) investments; or • Available-for-sale (AFS) financial assets All financial assets except for those at fair value through profit or loss (FVPL) are subject to review for impairment at least at each reporting date to identify whether there is any objective evidence that a financial asset or a group of financial assets is impaired. Different criteria to determine impairment are applied for each category of financial assets, which are described below. All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs, finance income or other financial items, except for impairment of trade receivables which is presented within other expenses. Loans and receivables Loans and receivables are non- derivative financial assets with fixed or determinable payments that are not quoted in an active market. After initial recognition, these are measured at amortised cost using the effective interest method, less provision for impairment. Discounting is omitted The Group’s trade and most other receivables fall into this category of financial instruments. Individually significant receivables are considered for impairment when they are past due or when other objective evidence is received that a specific counterparty will default. Receivables that are not considered to be individually impaired are reviewed for impairment in groups, which are determined by reference to the industry and region of a counterparty and other shared credit risk characteristics. The impairment loss estimate is then based on recent historical counterparty default rates for each identified group. Financial assets at fair value through profit or loss (FVPL) Financial assets at fair value through profit or loss (FVPL) include financial assets that are either classified as held for trading or that meet certain conditions and are designated at FVPL upon initial recognition. All derivative financial instruments fall into this category, except for those designated and effective as hedging instruments, for which the hedge accounting requirements apply (see below). Assets in this category are measured at fair value with gains or losses recognised in profit or loss. The fair values of financial assets in this category are determined by reference to active Held-to-maturity (HTM) investments Held-to-maturity (HTM) investments are non-derivative financial assets with fixed or determinable payments and fixed maturity other than loans and receivables. Investments are classified as HTM if the Group has the intention and ability to hold them until maturity. The Group currently does not hold items designated into this category. Held-to-maturity (HTM) investments are measured subsequently at amortised cost using the effective interest method. If there is objective evidence that the investment is impaired, determined by reference to external credit ratings, the financial asset is measured at the present value of estimated future cash flows. Any changes to the carrying amount of the investment, including impairment losses, are recognised in profit or loss. Available-for-sale (AFS) financial assets Available-for-sale (AFS) financial assets are non-derivative financial assets that are either designated to this category or do not qualify for inclusion in any of the other categories of financial assets. The Group’s currently has no AFS financial assets. Equity investments are measured at cost less any impairment charges. Where its fair value cannot be estimated reliably. Impairment charges are recognised in profit or loss. All other Available-for-sale (AFS) financial assets are measured at fair value. Consolidated Financial Statements for the Year Ended 30 June 2019 27 Gains and losses are recognised in other comprehensive income and reported within the AFS reserve within equity, except for impairment losses and foreign exchange differences on monetary assets, which are recognised in profit or loss. When the asset is disposed of or is determined to be impaired the cumulative gain or loss recognised in other comprehensive income is reclassified from the equity reserve to profit or loss and presented as a reclassification adjustment within other comprehensive income. Interest calculated using the effective interest method and dividends are recognised in profit or loss within ‘finance income’. Reversals of impairment losses for AFS debt securities are recognised in profit or loss if the reversal can be objectively related to an event occurring after the impairment loss was recognised. For AFS equity investments impairment reversals are not recognised in profit loss and any subsequent increase in fair value is recognised in other comprehensive income. Classification and subsequent measurement of financial liabilities The Group’s financial liabilities include borrowings, trade and other payables and derivative financial instruments. Financial liabilities are measured subsequently at amortised cost using the effective interest method, except for financial liabilities held for trading or designated at FVPL, that are carried subsequently at fair value with gains or losses recognised in profit or loss. undiscounted amounts expected to be paid when the liabilities are settled. an expense in the period that relevant employee services are received. All derivative financial instruments that are not designated and effective as hedging instruments are accounted for at FVPL. All interest-related charges and, if applicable, changes in an instrument’s fair value that are reported in profit or loss are included within finance costs or finance income. o. Equity and reserves Share capital represents the fair value of shares that have been issued. Any transaction costs associated with the issuing of shares are deducted from share capital, net of any related income tax beneﬁts. Other components of equity include the following: • Option reserve. Comprises equity settled share-based remuneration plans for the Group’s employees • Retained earnings/(Accumulated losses) include all current and prior period retained proﬁts/(losses) p. Employee beneﬁts Short-term employee beneﬁts Short-term employee beneﬁts are beneﬁts, other than termination beneﬁts, that are expected to be settled wholly within twelve (12) months after the end of the period in which the employees render the related service. Examples of such beneﬁts include wages and salaries, non-monetary beneﬁts and accumulating sick leave. Short-term employee beneﬁts are measured at the Other long-term employee beneﬁts The Group’s liabilities for long service leave are included in other long term beneﬁts as they are not expected to be settled wholly within twelve (12) months after the end of the period in which the employees render the related service. They are measured at the present value of the expected future payments to be made to employees. The expected future payments incorporate anticipated future wage and salary levels, experience of employee departures and periods of service, and are discounted at rates determined by reference to market yields at the end of the reporting period on high quality corporate bonds that have maturity dates that approximate the timing of the estimated future cash outflows. Any re-measurements arising from experience adjustments and changes in assumptions are recognised in proﬁt or loss in the periods in which the changes occur. The Group presents employee beneﬁt obligations as current liabilities in the statement of ﬁnancial position if the Group does not have an unconditional right to defer settlement for at least twelve (12) months after the reporting period, irrespective of when the actual settlement is expected to take place. Deﬁned contribution plans The Group pays ﬁxed contributions into independent entities in relation to several state plans and insurance for individual employees. The Group has no legal or constructive obligations to pay contributions in addition to its ﬁxed contributions, which are recognised as q. Provisions, contingent liabilities and contingent assets Provisions for product warranties, legal disputes, make good obligations, onerous contracts or other claims are recognised when the Group has a present legal or constructive obligation as a result of a past event, it is probable that an outflow of economic resources will be required from the Group and amounts can be estimated reliably. Timing or amount of the outflow may still be uncertain. Provisions are measured at the estimated expenditure required to settle the present obligation, based on the most reliable evidence available at the reporting date, including the risks and uncertainties associated with the present obligation. Where there are a number of similar obligations, the likelihood that an outflow will be required in settlement is determined by considering the class of obligations as a whole. Provisions are discounted to their present values, where the time value of money is material. Any reimbursement that the Group can be virtually certain to collect from a third party with respect to the obligation is recognised as a separate asset. However, this asset may not exceed the amount of the related provision. No liability is recognised if an outflow of economic resources as a result of present obligation is not probable. Such situations are disclosed as contingent liabilities, unless the outflow of resources Consolidated Financial Statements for the Year Ended 30 June 2019 28 is remote in which case no liability is recognised. r. Share-based employee remuneration The Group operates equity settled share-based remuneration plans for its employees. This fair value is appraised at the grant date and excludes the impact of non- market vesting conditions (for example proﬁtability and sales growth targets and performance conditions). All share-based remuneration is ultimately recognised as an expense in proﬁt or loss with a corresponding credit to share option reserve. If vesting periods or other vesting conditions apply, the expense is allocated over the vesting period, based on the best available estimate of the number of share options expected to vest. Non-market vesting conditions are included in assumptions about the number of options that are expected to become exercisable. Estimates are subsequently revised if there is any indication that the number of share options expected to vest differs from previous estimates. Any cumulative adjustment prior to vesting is recognised in the current period. No adjustment is made to any expense recognised in prior periods if share options ultimately exercised are different to that estimated on vesting. Upon exercise of share options, the proceeds received net of any directly attributable transaction costs are allocated to share capital. s. Revenue For licence revenue, and in order to determine whether to recognise revenue, the Group follows a 5-step process: position, depending on whether something other than the passage of time is required before the consideration is due. 1. 2. Identifying the contract with a customer, Identifying the performance obligations, 3. Determining the transaction price, 4. Allocating the transaction price to the performance obligations, 5. Recognising revenue when/as performance obligation(s) are satisfied. The Group will enter into licence transactions and receive upfront and milestone payments as part of research and development collaborations or out- licensing agreements. The total transaction price for a contract is allocated amongst the various performance obligations based on their relative stand-alone selling prices using the residual method and cost method. Revenue is recognised either at a point in time or over time, when (or as) the Group satisfies performance obligations by transferring the promised goods or services to its customers. The Group recognises contract liabilities for consideration received in respect of unsatisfied performance obligations or where revenue is constrained and reports these amounts as contract liabilities in the statement of financial position. Similarly, if the Group satisfies a performance obligation before it receives the consideration, the Group recognises either a contract asset or a receivable in its statement of financial Licence revenue is determined with reference to performance obligations to provide either patents or IP. Licence revenues are considered a right to use and recognised at a point in time, net of any revenue constraints. Revenue from the sale of goods is recognised at the point of delivery as this corresponds to the transfer of signiﬁcant risks and rewards of ownership of the goods and the cessation of all involvement in those goods. Revenue relating to the provision of services is recognised when the services are provided. Interest revenue is recognised using the effective interest rate method. All revenue is stated net of the amount of goods and services tax (GST). The assessment of the criteria for income recognition and the determination of the appropriate period during which income is recognised are subject to judgement where variable consideration that is constrained and revenue is recognised only when it is highly probable that there will not be a significant reversal of revenue. t. Goods and services tax (GST) Revenues, expenses and assets are recognised net of the amount of GST, except where the amount of GST incurred is not recoverable from the Australian Taxation Ofﬁce. In these circumstances, the GST is recognised as part of the cost of acquisition of the asset or as part of an item of the expense. Receivables and payables in the statement of ﬁnancial position are shown inclusive of GST. Cash flows are presented in the statement of cash flows on a gross basis, except for the GST component of investing and ﬁnancing activities, which are disclosed as operating cash flows. u. Research and development Expenditure during the research phase of a project is recognised as an expense when incurred. The research and development incentive is calculated and accrued at year end and is recognised in accordance with ‘AASB 120 Accounting for Government Grants’. The amount is credited to other income and the receivable is included in the Consolidated Statement of Financial Position as a current R&D incentive receivable. v. Operating expenses Operating expenses are recognised in proﬁt or loss upon utilisation of the service or at the date of their origin. Expenditure for warranties is recognised and charged against the associated provision when the related revenue is recognised. w. Signiﬁcant management judgments and estimates in applying accounting policies The Directors evaluate estimates and judgments incorporated into the ﬁnancial report based on historical knowledge and best available current information. Consolidated Financial Statements for the Year Ended 30 June 2019 29 Estimates assume a reasonable expectation of future events and are based on current trends and economic data. When preparing the ﬁnancial statements, management undertakes a number of judgments, estimates and assumptions about the recognition and measurement of assets, liabilities, income and expenses. Estimation uncertainty Information about estimates and assumptions that have the most signiﬁcant effect on recognition and measurement of assets, liabilities, income and expense is provided below. Actual results may be substantially different. Share options and performance rights Share options were valued using a variation of the binomial option pricing model. Historical volatility has been the basis for determining expected share price volatility as it is assumed that this is indicative of future movements. For purposes of the valuation the assumed life of the options was based on the historical exercise patterns, which may not eventuate in the future. No special features inherent to the options granted were incorporated into measurement of fair value. Where approval is required at the AGM and the service period has commenced the expense is measured from the service period start date and is re-measured at grant date (being AGM). Any true up/adjustment is reflected in future periods. Research and development claim In calculating the R&D incentive, the Group has treated certain research and development activities as eligible expenditure under the Australian Government tax incentive. Management has assessed these activities and expenditures undertaken in Australia and overseas to determine which are likely to be eligible under the incentive scheme. At each period end, management estimates the refundable R&D incentive available to the Group based on current information. This estimate is also reviewed by external tax advisors. For the years ended 30 June 2019 and 2018, the Group has recognised income of $1.44 million and $2.16 million respectively. Refer note 6. Uncertainties in the estimate relate to expenditure that can be claimed under the scheme including in some cases the claimable percentages applied to certain expenditure. Joint venture assessment In respect of Regeneus Japan Inc. management has determined that the Group does not have control in accordance with the criteria outlined in AASB 10. Management has made an assessment that the joint arrangement represents a joint venture rather than a joint operation in accordance with the requirements of AASB 11 and has therefore accounted for the investment using the equity method. Licence revenue In December 2016 the Company entered into a Manufacturing Licence Agreement and Shareholders Agreement with AGC. As part of these arrangements and in satisfaction of performance obligations the Company received an upfront payment and milestone payments totalling US$6.5million. The Shareholders Agreement anticipated that AGC and Regeneus would work together to secure a marketing partner for the clinical development and commercialisation of Progenza in Japan. Furthermore, if securing such a partner was not achieved by 31 December 2018 then AGC had the opportunity to use US$2.5 million, paid as upfront and milestone payments, to subscribe for shares in Regeneus and to also cancel the arrangements. Throughout the intervening period from signing the agreements to 31 December 2018 both parties worked diligently to appoint a marketing partner and expected that it would be finalised within the period. As set out in the 30 June 2018 annual report, Management determined that the Group had met the revenue criteria outlined in AASB 118 in respect of the milestone payments received during the prior year under the AGC Manufacturing Licence Agreement. As part of this assessment management made judgements relating to the probability of obtaining future milestone payments and the probability that any of the payments received to date may be subject to repayment or claw back provisions. On adoption of AASB 15 Management determined that an adjustment of $3,384,150 (representing US$2.5m translated at the spot rate on the date of transition) was required to the opening balances as a result of AASB 15 having a higher threshold in respect of constrained revenue than AASB 118. As at 30 June 2019, a marketing partner has not been appointed. AGC has not taken the requisite steps to invoke the necessary termination clauses in the agreements. Should AGC invoke the relevant clauses in the Agreements, the financial liability would be settled in shares. As at 30 June 2019 the potential share issuance was equivalent to 41,932,941 shares at $0.085 totalling $3,564,300 (representing US$2.5m translated at the spot rate at 30 June 2019). These shares remain unissued at the date of this report. Loans to Shareholder The Group holds full recourse loans to shareholders totalling $896,157 that were provided at the time of the 2013 IPO. As outlined above, the Group has made an adjustment for expected credit losses. The Group assesses expected credit losses with reference to the history of losses and considering the value of shares held by the shareholders to determine future expected credit losses. The provision for expected credit losses has been raised against the loans to shareholders, reflecting the reduction in the share price to $0.085 at balance date and the expected credit loss on realising these loans. Consolidated Financial Statements for the Year Ended 30 June 2019 30 6. Revenue and other income Operating activities Licence fee income Grants received Interest received Total revenue Other income R&D incentive Total other income 2019 $ - 6,000 19,077 25,077 2018 $ 575,406 - 35,105 610,511 1,441,782 1,441,782 2,164,595 2,164,595 4. Controlled entities Set out below are details of the subsidiaries held directly by the Group. Name of the subsidiary Regeneus Animal Health Pty Ltd Cell Ideas Pty Ltd Country of incorporation & principal place of business Australia 25 Bridge Street, Pymble NSW 2073 Australia 25 Bridge Street, Pymble NSW 2073 Principal activity Group proportion of ownership interests 30 June 2019 30 June 2018 Non-trading 100% 100% Non-trading owns various IP 100% 100% 5. Segment reporting Identiﬁcation of reportable income segments The Group’s operating segment is based on the internal reports that are reviewed and used by the Board of Directors (being the Chief Operating Decision Makers (CODM)) in assessing performance and in determining the allocation of resources. Following an assessment of the information provided to the CODM, it has been concluded that the Group operates in only one segment, being the development of innovative cell- based therapies to address signiﬁcant unmet medical needs in human and veterinary health. The segment result is as shown in the statement of proﬁt or loss and other comprehensive income. Refer to statement of ﬁnancial position for assets and liabilities. Consolidated Financial Statements for the Year Ended 30 June 2019 31 7. Results for the year The results for the year have been arrived at after charging the following items: 9. Inventories Inventories consist of the following: a. Expense Rental expense on operating leases minimum lease payment Amortisation of intangible assets Depreciation Loss on disposal of assets 2019 $ 436,562 1,644 269,136 2,284 2018 $ 382,826 4,115 Raw materials and consumables at cost Less: Provisions Total inventories 2019 $ 13,014 (4,399) 8,615 2018 $ 31,733 (16,397) 15,336 343,845 Inventories are utilised in R&D projects and other operational activities. - Employment expenses (excludes share-based payment) 2,743,048 2,974,821 10. R&D incentive receivable Superannuation expense Share-based payments b. Finance costs - Interest expense - Bank and finance charges Total finance costs 8. Cash and cash equivalents Cash and cash equivalents include the following components: Cash on hand Cash at bank (AUD account) Cash at bank (USD account) Total cash and cash equivalents 247,302 100,490 320,926 81,874 402,800 2019 $ 11 255,310 142 255,463 253,577 6,457 2,350 23,512 25,862 2018 $ 11 1,011,077 80,491 Current R&D incentive receivable Total R&D incentive receivable 11. Other current assets Prepayments Security deposits GST receivable Security deposit on leased premises 1,091,579 Other current assets 2019 $ 2018 $ 1,249,440 1,249,440 2,164,595 2,164,595 2019 $ 14,609 - 50,407 210,000 275,016 2018 $ 44,044 38,743 62,520 - 145,307 Consolidated Financial Statements for the Year Ended 30 June 2019 32 12. Financial assets at amortised cost 13. Plant and equipment Shareholder loan Expected credit loss allowance Shareholder loan 2019 $ 896,157 (300,000) 596,157 2018 $ 896,157 - 896,157 The shareholder loan is a full recourse, interest-free loan for 4 years initially maturing September 2017. Having extended the maturity to the 15 June 2018 the Directors considered that it was in all shareholders interest if the loan repayment was extended a further 12 months to 15 June 2019. These loans are currently repayable. While the loan is full recourse, in accordance with AASB 9 the ECL (expected credit loss) model credit risk has increased as the amounts are overdue and the share price has reduced. Accordingly, an expected credit loss allowance has been made. Details of the Group’s property, plant and equipment and their carrying amounts are as follows: Office equipment $ Lab equipment $ Equipment in clinics $ Office fit-out $ Total $ Gross carrying amount Balance 1 July 2018 146,810 611,362 52,116 1,168,665 1,978,953 Additions Disposals 5,666 1,954 7,620 12,585 - - - 12,585 Balance 30 June 2019 139,891 613,316 52,116 1,168,665 1,973,988 Depreciation and impairment Balance 1 July 2018 (85,900) (412,304) (52,116) (1,011,385) (1,561,705) At the date of this report the share price was $0.07, if this was the share price at reporting date an additional impairment of $84k would have been recorded in respect of the shareholder loans receivable. Disposals Depreciation 10,301 - (29,632) (82,224) - - - 10,301 (157,280) (269,136) Included within the shareholder loan are balances owing by the Directors of the financial year as follows: Balance 30 June 2019 (105,231) (494,528) (52,116) (1,168,665) (1,820,540) Carrying amount 30 June 2019 34,660 118,788 - - 153,448 John Martin Graham Vesey 2019 $ - 150,552 2018 $ 295,925 150,552 John Martin resigned as a Director 29 March 2019. The loan to John Martin of $295,925 remains payable at 30 June 2019. Gross carrying amount Balance 1 July 2017 119,613 487,593 52,116 1,168,665 1,827,987 Additions Disposals 27,197 123,769 - - - - - - 150,966 - Balance 30 June 2018 146,810 611,362 52,116 1,168,665 1,978,953 Depreciation and impairment Balance 1 July 2017 (56,644) (346,941) (49,820) (764,455) (1,217,860) Disposals Depreciation - - - - - (29,256) (65,363) (2,296) (246,930) (343,845) Balance 30 June 2018 (85,900) (412,304) (52,116) (1,011,385) (1,561,705) Carrying amount 30 June 2018 60,910 199,058 - 157,280 417,248 Consolidated Financial Statements for the Year Ended 30 June 2019 33 14. Intangible assets Details of the Group’s intangible assets and their carrying amounts are as follows: Acquired software licenses $ Gross carrying amount Balance at 1 July 2018 Balance at 30 June 2019 Amortisation and impairment Balance at 1 July 2018 Amortisation Balance at 30 June 2019 Carrying amount 30 June 2019 Gross carrying amount Balance at 1 July 2017 Balance at 30 June 2018 Amortisation and impairment Balance at 1 July 2017 Amortisation Balance at 30 June 2018 Carrying amount 30 June 2018 82,561 82,561 (80,917) (1,644) (82,564) - 82,561 82,561 (76,802) (4,115) (80,917) 1,644 Total $ 82,561 82,561 (80,917) (1,644) (82,561) - 82,561 82,561 (76,802) (4,115) (80,917) 1,644 15. Investments accounted for using the equity method The Group has one material joint venture - Regeneus Japan Inc, an entity incorporated in Japan with its principal place of business in Shibuya-ku, Tokyo. The company is owned 50% by Regeneus Ltd and 50% by AGC and its purpose is the ‘Management of Domestic (ie Japanese) licences (Development and Marketing) and all business incidental to this purpose’. The investment is accounted for using the equity method in accordance with AASB 128. Summarised financial information for Regeneus Japan Inc. is set out below: Total assets (a) Total liabilities Net assets (a) Includes cash and cash equivalents Revenue Expenses Total comprehensive loss for the year Share of comprehensive loss for the year Exchange gain / (loss) on investment 2019 $ 7,350 - 7,350 7,350 - (81,806) (81,806) (40,903) 3,315 Loss on investment accounted for using equity method (37,588) 2018 $ 82,526 - 82,526 82,526 - (79,700) (79,700) (39,850) 3,113 (36,737) A reconciliation of the above summarised financial information to the carrying amount of the investment in Regeneus Japan Inc. is set out below: Total net assets of Regeneus Japan Inc Proportion of ownership interests held by the Group Carrying amount of the investment in Regeneus Japan inc. 7,350 50% 3,675 82,526 50% 41,263 The joint venture has no commitments or contingent liabilities other than those incurred in the normal course of business as at 30 June 2019 (2018:nil) Consolidated Financial Statements for the Year Ended 30 June 2019 34 16. Other non-current assets 18. Provisions Non-current Security deposit Total other non-current assets 17. Trade and other payables Trade and other payables consists of the following: Current Trade payables Accruals PAYG Payable Total trade and other payables 2019 $ - - 2019 $ 391,306 607,982 56,658 1,055,946 2018 $ 210,000 210,000 2018 $ 372,157 266,078 68,974 707,209 All amounts are short term and the carrying values are considered to be a reasonable approximation of fair value. 17.1 Foreign currency risk The carrying amount of trade and other payables denominated in foreign currencies is: US dollar Japanese Yen 2019 $/ ¥ 12,078 350,000 2018 $ 111,150 - Current: Annual leave Opening balance 1 July Benefits accrued / (expensed) Balance as at 30 June Current: Long service leave Opening balance 1 July Benefits transferred from non-current Balance as at 30 June Current: Make good Opening balance 1 July Provision accrued Balance as at 30 June Total current provisions Non-current: Long service leave Opening balance 1 July Benefits accrued Benefits transferred to current Balance as at 30 June Non-current: Make good Opening balance 1 July Provision accrued Balance as at 30 June 2019 $ 111,398 (8,917) 102,481 - 40,196 40,196 53,700 156,300 210,000 352,677 189,057 26,525 (40,196) 175,386 - - - Total non-current provisions 175,386 2018 $ 115,484 (4,086) 111,398 - - - - - - 111,398 136,707 52,350 - 189,057 52,000 1,700 53,700 242,757 The provision for Make good is estimated future cost of the make good of the operating lease and is based on management’s best estimate of the cost to restore the leased premises to their agreed pre-fit-out state at the expiration of the lease agreement. Consolidated Financial Statements for the Year Ended 30 June 2019 35 As set out in the 30 June 2018 annual report, Management determined that the Group had met the revenue criteria outlined in AASB 118 in respect of the milestone payments received during the prior year under the AGC Manufacturing Licence Agreement. As part of this assessment management made judgements relating to the probability of obtaining future milestone payments and the probability that any of the payments received to date may be subject to repayment or claw back provisions. On adoption of AASB 15 Management determined that an adjustment of $3,384,150 to recognise a contract liability (representing US$2.5m translated at the spot rate on the date of transition) was required to the opening balances as a result of AASB 15 having a higher threshold in respect of constrained revenue than AASB 118. At 31 December 2018, the milestone was not met, and management determined that constrained revenue would not be recognised as revenue. Instead it was expected that there would be an obligation to issue a variable number of shares. Accordingly, the contract liability has been transferred to a financial liability on 1 January 2019. As at 30 June 2019, a marketing partner has not been appointed. AGC has not taken the requisite steps to invoke the necessary clauses in the agreements. Should AGC invoke the relevant clauses in the Agreements, the contract liability would be settled in shares. As at 30 June 2019 the potential share issuance was equivalent to 41,932,941 shares at $0.085 totalling $3,564,300. These shares remain unissued at the date of this report. 19. Other current liabilities Current Related party loan Directors loan Total other current liabilities 2019 $ 1,280,000 2,500,000 3,780,000 2018 $ 1,000,000 - 1,000,000 The Related party loan is the R&D loan facility provided by Paddington St Finance Pty Ltd. The Directors Loan relates to commercial loans provided by a number of Directors in February 2019, refer to note 28 for additional disclosure in relation to these balances. 20. Financial liabilities Current Financial liabilities Total financial liabilities 2019 $ 3,564,300 3,564,300 2018 $ - - In December 2016 the Company entered into a Manufacturing Licence Agreement and Shareholders Agreement with AGC. As part of these arrangements and in satisfaction of performance obligations the Company received an upfront payment and milestone payments totalling US$6.5million. The Shareholders Agreement anticipated that AGC and Regeneus would work together to secure a marketing partner for the clinical development and commercialisation of Progenza in Japan. Furthermore, if securing such a partner was not achieved by 31 December 2018 then AGC had the opportunity to use US$2.5million, paid as upfront and milestone payments, to subscribe for shares in Regeneus and to also terminate the arrangements. Throughout the intervening period from signing the agreements to 31 December 2018 both parties worked diligently to appoint a marketing partner and expected that it would be finalised within the requisite period. Consolidated Financial Statements for the Year Ended 30 June 2019 36 21. Equity 22. Employee remuneration 21.1 Share capital The share capital of Regeneus Ltd consists only of fully paid ordinary shares which do not have a par value. All shares are equally eligible to receive dividends and the repayment of capital, and represent one vote at the shareholders’ meeting of Regeneus Ltd. 2019 shares 2018 shares 2019 $ 2018 $ Shares issued and fully paid Beginning of the year 208,885,143 208,885,143 31,076,819 31,076,819 Shares issued - - - - Closing balance at the end of the year 208,885,143 208,885,143 31,076,819 31,076,819 During 2019, no shares or options were issued. (2019: nil). 21.2 Reserves The details of reserves are as follows: Balance at 30 June 2017 Share options expense Options exercised Share option reserve $ Total reserves $ 1,652,773 1,652,773 6,457 6,457 - - Transfer from reserves to retained earnings for options forfeited (39,780) (39,780) Balance at 30 June 2018 Share options expense Options exercised 1,619,450 1,619,450 100,490 100,490 - - Transfer from reserves to retained earnings for options forfeited (1,307,875) (1,307,875) Balance at 30 June 2019 412,065 412,065 22.1 Share-based employee remuneration As at 30 June 2019 the Group maintained share-based option plans as part of employee remuneration. 5 million options were awarded in January 2019. Share options and weighted average exercise prices are as follows for the reporting periods presented. Share options Employee share option plan Option share trust Total share options Number Weight avg exercise price $ Number Weight avg exercise price $ Number Weight avg exercise price $ 2,733,834 0.16 6,888,210 0.24 9,622,044 0.22 - - (462,060) 0.14 - - - - - - - - - - (462,060) 0.14 - 2,271,774 0.17 6,888,210 0.24 9,159,984 - - 5,000,000 0.23 5,000,000 (500,000) 0.28 (5,988,210) 0.25 (5,988,210) - - - - - 1,771,774 0.14 5,900,000 0.22 7,671,774 - 0.22 0.23 0.25 - 0.20 1,771,774 0.14 900,000 0.16 2,671,774 0.15 1,771,774 0.14 3,400,000 0.19 5,171,774 0.17 Outstanding at 1 July 2017 Granted Forfeited Exercised Outstanding at 30 June 2018 Granted Forfeited Exercised Outstanding at 30 June 2019 Exercisable at 30 June 2019 Exercisable at 30 June 2020 Other details of options currently outstanding: • • • The range of exercise prices is $0.136 to $0.250 The weighted average remaining contractual life is approximately 3 years The 5 million options awarded in January 2019 are subject to approval at the AGM Consolidated Financial Statements for the Year Ended 30 June 2019 37 The share options were valued using a variation of the binomial option pricing model. The following principal assumptions were used in the valuation: 23. Leasing 23.1 Operating leases as lessee In November 2013 the Group entered a 5 year 4 month operating lease for its office and production facilities. The lease payments are secured by a deposit of $210,000. The future minimum lease payments are as follows: 30 June 2019 30 June 2018 Minimum lease payments due Within 1 year $ - 225,165 1-5 years $ - - After 5 years $ - - Total $ - 225,165 During the current financial year the Group waived its right to exercise a 5 year option on its current premises and the lease expired 31 March 2019. The Group continues to rent the premises on a monthly basis. As part of a strategic review, premises requirements are being determined and will be resolved during FY2020. Further details are highlighted in the Subsequent events disclosure. Valuation assumptions Grant date 1 Jul 2010 21 Feb 2011 21 Oct 2014 Share price at date of grant Volatility Option life Dividend yield Risk free investment rate Fair value at grant date Exercise price at date of grant $0.136 45% $0.136 45% 10 years 10 years 0% 5.10% $0.085 $0.136 0% 5.60% $0.085 $0.136 $0.160 244% 5 years 0% 2.80% $0.179 $0.160 Grant date 31 Jan 2019 31 Jan 2019 Share price at date of grant Volatility Option life Dividend yield Risk free investment rate Fair value at grant date Exercise price at date of grant $0.155 57% 5 years 0% 1.9% $0.067 $0.20 $0.155 57% 5 years 0% 1.9% $0.058 $0.25 In total, $100,490 (2018: $6,457), of employee remuneration expense (all of which related to equity settled share-based payment transactions) has been included in profit or loss and credited to share option reserve. Volatility has been determined based on the historic share price volatility as it is assumed that this is indicative of future movements. Option life is based on the nominated expiry date of the option and historical exercise patterns, which may not eventuate. Consolidated Financial Statements for the Year Ended 30 June 2019 38 24. Income tax expense 25. Auditor’s remuneration The major components of tax expense and the reconciliation of the expected tax expense based on the domestic effective tax rate of Regeneus Ltd at 27.5% (2018: 27.5%) and the reported tax expense in profit or loss are as follows: The prima facie tax on (loss) / profit before income tax is reconciled to the income tax as follows Prima facie tax receivable on (loss) / profit before income tax at 27.5% Less: Tax effect of: 2019 $ 2018 $ (1,656,765) (1,425,765) - Research and development incentive (396,490) (595,264) - Tax losses applied / (not brought to account) - - Add: Tax effect of: - Non-deductible expenses - Timing differences - Tax losses not brought to account Income tax benefit The applicable weighted average effective tax rates are as follows: Deferred tax losses not recognised Tax losses not recognised Capital losses not recognised Other deferred tax assets not recognised Total Potential tax benefit 1,008,459 1,978,301 227,328 42,728 817,468 - 0% 2019 $ - - 0% 2018 $ 8,460,797 2,610,199 833,534 833,534 3,425,339 1,676,068 12,719,670 5,119,801 3,497,909 1,407,945 Audit and review of financial statements - Auditors of Regeneus Ltd – Grant Thornton 115,000 95,000 Remuneration for audit and review of financial statements 115,000 95,000 2019 $ 2018 $ Other services Other services Total other services remuneration Total auditor’s remuneration - - - - 115,000 90,000 26. Earnings per share Both the basic and diluted earnings per share have been calculated using the loss attributable to shareholders of the Parent Company as the numerator (i.e. no adjustments to the loss were necessary in 2019 or 2018). The reconciliation of the weighted average number of shares for the purposes of diluted earnings per share to the weighted average number of ordinary shares used in the calculation of basic earnings per share is as follows: 2019 $ 2018 $ Earnings per share Basic earnings per share from continuing operations (0.029) (0.025) The weighted average number of ordinary shares used as the denominator on calculating the EPS 208,885,143 208,885,143 Diluted earnings per share Diluted earnings per share from continuing operations (0.029) (0.025) The weighted average number of ordinary shares used as the denominator on calculating the DEPS 208,885,143 208,885,143 Share options have not been included in the diluted EPS calculation because they are anti-dilutive. Consolidated Financial Statements for the Year Ended 30 June 2019 39 27. Reconciliation of cash flows from operating activities 28. Related party transactions and loans 2019 $ 2018 $ On 29 June 2018 the Group entered into an R&D loan facility agreement with Paddington St Finance Pty Ltd, a related party. The facility forward funded, via a loan, the lesser of 80% of the expected claim or $2m. Cash flows from operating activities (Loss) / Profit for the period Non cash adjustments for: • Depreciation • Amortisation • Loss on disposal of plant and equipment (6,024,600) (5,184,600) 269,136 343,845 1,644 2,284 4,115 - • Equity settled share-based transactions 100,490 6,457 • Interest - unwinding of shareholder loan • Provision for shareholder loan • Unrealised foreign exchange gain / (loss) • Share of loss of on investments accounted for using the equity method Net changes in working capital: • Change in inventories • Change in trade and other receivables • Change in other assets • Change in trade and other payables • Change in other employee obligations • Change in tax assets • Change in other liabilities • Change in provisions - (21,855) 300,000 - 176,835 (3,113) 40,903 39,850 6,721 6,612 - 770 80,291 120,791 361,053 (43,266) (12,316) 7,266 915,155 443,627 - (17,502) 173,908 49,964 Net cash inflow / (outflow) from operating activities (3,608,496) (4,247,040) The loan was finalised after Regeneus received a waiver from the ASX listing rule 10.1 necessitated as Mr Barry Sechos, a Director of Regeneus is also a Director of Paddington St Finance a commercial R&D financier. The waiver permitted Regeneus to grant security by way of a first ranking fixed and floating charge over all of its assets and undertakings in favour of Paddington St Finance. Regeneus had considered funding from other sources and determined that Paddington St Finance was the most attractive commercial arrangement and entered into the necessary arrangements on arm’s length terms that the Directors (with Mr Sechos abstaining) consider to be fair and reasonable from the perspective of the Regeneus security holder. Interest is charged at a rate typical for this type of funding. On 27 August 2018, the Board of Directors renegotiated the payment terms of the loan to Paddington St Finance Pty Ltd. Paddington St Finance agreed to defer the repayment of the loan to the earlier of receipt of the next milestone payment under the manufacturing licence with AGC; the receipt of the FY19 R&D Tax Incentive; and 30 September 2019. In February 2019 the terms were further amended such that all interest from 1 October 2018 is accrued. The accrued interest and principal will be repayable from the Group’s R&D tax incentive receipts for 2019 unless the Group has raised more than $6 million from either a capital raise or the sale, licensing or other disposal of any of the Group’s assets. Where $6 million has not been raised and the R&D tax incentive receipts for 2019 are insufficient to repay the principal and capitalised interest, the Group will enter into a new loan deed, on substantially the same terms, in respect of the balance of principal and accrued interest remaining, which will be repayable from the Group’s R&D tax incentive receipts for 2020. The initial drawdown in FY18 was for $1.00 million. During the reporting period a number of further drawdowns were undertaken increasing the loan to $1.88 million. Subsequent repayments and redraws over the year have given rise to a principal loan balance at 30 June 2019 of $1.28 million. Full repayment of the loan is anticipated to be completed by the end of September 2019. On the 28 February 2019, the Company received loans from the Directors totalling $2,500,000. Regeneus had previously considered funding from other sources and determined these Director loans were the most attractive commercial arrangement and entered into the necessary arrangement on arm’s length terms. The loans are unsecured and repayable on the earlier of 2 March 2020 or 10 days after a capital raise sufficient to fund repayment of the loans of the Company and support the working capital requirements of the Company for the following 12 months, as reasonably determined by the Board of Directors. Consolidated Financial Statements for the Year Ended 30 June 2019 40 Related party transactions Paddington St Finance Pty Ltd Balance at beginning of the year Loan received Loan repaid Balance at year end Interest charged Net received from Paddington St Finance Directors Loans Received Leo Lee Barry Sechos Glen Richards John Martin Balance at year end Interest charged Total received from Directors Total received from related parties 2019 $ 2018 $ 29. Transactions with key management personnel Key management personnel remuneration includes the following expenses: 1,000,000 2,160,000 (1,880,000) 1,280,000 (194,627) 85,373 2,100,000 250,000 100,000 50,000 2,500,000 (125,000) 2,375,000 2,460,373 2019 $ 886,512 - 886,512 40,723 (34,879) 100,490 992,846 2018 $ 757,000 250,000 1,007,000 51,015 12,674 - 1,070,689 - 1,000,000 - Salaries & Fees Short term incentive 1,000,000 Total short-term employee benefits - Defined contribution pension plans 1,000,000 Other long-term benefits Share-based payments Total remuneration - - - - - - - During the year, no options were exercised. Disclosures relating to key management personnel are set out in this note and the remuneration report in the Directors’ report. 30. Contingent liabilities 1,000,000 The Group has no contingent liabilities as at 30 June 2019 (30 June 2018: $nil). In addition, a balance of $152,143 (2018: $nil) due to Paddington Street Finance and interest accrued of $125,000 due on the director’s loans is included in trade payables. 31. Capital expenditure commitments There were no capital commitments as at the 30 June 2019 (30 June 2018: $nil). Loans receivable relate to the shareholder loan, terms of which are disclosed in Note 13 Related party loan receivable John Martin Graham Vesey Total related party loans 2019 $ - 150,552 150,552 2018 $ 295,925 150,552 446,477 John Martin resigned as a Director 29 April 2019. The loan to John Martin of $295,925 remains payable at 30 June 2019. Consolidated Financial Statements for the Year Ended 30 June 2019 41 32. Financial instruments a. Capital risk management The Group’s financial instruments consist mainly of deposits with banks, accounts receivable, deposits, shareholder loans, accounts payable and financial liabilities. b. Categories of financial instruments The total for each category of financial instrument, measured in accordance with AASB 9 as detailed in the accounting policies to these financial statements, are as follows: Financial assets at amortised cost Trade and other receivables Cash and cash equivalents Shareholder loan Total financial assets at amortised cost Financial liabilities at amortised cost Trade and other payables Related party loan Directors’ loans Financial liabilities Total financial liabilities at amortised cost 2019 $ - 255,463 596,157 851,620 2019 $ 999,288 1,280,000 2,500,000 3,564,300 8,343,588 d. Foreign exchange risk Foreign exchange risk is the risk of an adverse impact on the Group’s financial performance as a result of exchange rate volatility. Foreign exchange risk arises when future commercial transactions and recognised assets and liabilities are denominated in a currency that is not the entity’s functional currency. The Group is exposed to foreign exchange risk arising primarily from transactions with foreign suppliers and the effect of foreign exchange rate volatility on a US denominated bank account, balance at 30 June 2019 US$100 (30 June 2018: US$59,462) and US$2.5m financial liability. Other exposure to currency risk arises from foreign currency transactions and is limited to trade payables. The Group does not frequently transact with foreign suppliers and the total AUD balance of trade payables denominated in a foreign currency (USD & JPY) at 30 June 2019 is $24,300 (2018: $111,150), therefore the Group’s net exposure is minimal. Management have assessed the risk of movement in interest rates, and foreign exchange, and do not believe the impact would be material to the accounts. The following table illustrates the sensitivity of profit in regards to the Group’s financial assets and financial liabilities and the USD / AUD and JPY / AUD exchange rate ‘all other things equal’. It assumes a +/- 10% change of the AUD / USD and the AUD / JPY exchange rate for the year ended at 30 June 2019 (2018: 10%). This percentage has been determined based on the average market volatility in exchange rates in the previous twelve (12) months. The sensitivity analysis is based on the Group’s foreign currency financial instruments held at each reporting date. 2018 $ - 1,091,579 896,157 1,987,736 2018 $ 638,235 1,000,000 Movements in the AUD / USD and the AUD / JPY would have the following impact: - - 1,638,235 Profit / (loss) impact of exchange rate sensitivity 2019 $ If AUD had strengthened against USD & JPY by 10% (2018: 10%) (177,188) 2018 $ 6,358 If AUD had weakened against USD & JPY by 10% (2018: 10%) 177,694 (7,770) c. Financial risk management objective The Group is exposed to various risks in relation to financial instruments. The main types of risks are foreign currency risk, credit risk and liquidity risk. The Group’s risk management is coordinated in close operation with the Board of Directors, and focuses on actively securing the Group’s short to medium term cash flows by minimising the exposure to financial markets. The Group does not actively engage in the trading of financial assets for speculative purposes. The most significant financial risks to which the Group is exposed are described below. Exposure to foreign exchange rates vary during the year depending on the volume of overseas transactions. Nonetheless the analysis above is considered to be representative of the Group’s exposure to currency risk. e. Liquidity risk analysis Liquidity risk is risk that the Group might be unable to meet its obligations. The Group manages its liquidity needs by monitoring forecast cash inflows and outflows due in day-to- day business. The data used for analysing these cash flows consistent with that used in the contractual maturity analysis below. Liquidity needs are monitored in a rolling 365 day projection. Consolidated Financial Statements for the Year Ended 30 June 2019 42 The Group’s objective is to maintain cash and deposits to meet its liquidity requirements for 180 day periods at a minimum. This objective relies on the Groups Capital Management Policies and in conjunction with these was met for the reporting periods. The Group considers expected cash flows from financial assets in assessing and managing liquidity risk in particular its cash resources and trade receivables. As at 30 June 2019 the Group’s non-derivative financial liabilities have contractual maturities as summarised below: 2019 Current within 6 months $ 2019 Current within 6 to12 months $ 2018 Current within 6 months $ 2018 Current within 6 to 12 months $ Trade and other payables 874,288 Related party loan 1,280,000 - - 638,235 1,000,000 Directors’ loans - 2,500,000 1,000,000 Financial Liabilities 3,564,300 - - Total financial liabilities 5,718,588 2,500,000 1,638,235 - - - - - f. Credit risk Credit risk refers to the risk that a counter party will default on its contractual obligations resulting in a financial loss to the Group. Credit risk arises from cash and cash equivalents, deposits with banks and financial institutions, as well as credit exposure to customers, including outstanding receivables and committed transactions. The Group has adopted a policy of only dealing with creditworthy counter parties as a means of mitigating the risk of financial loss from defaults. There are no significant concentrations of credit risk within the Group. Other financial assets at amortised cost include loans to shareholders. The Group applies the AASB 9 simplified model of recognising lifetime expected credit losses for loans to shareholders as these items do not have a significant financing component. In measuring the expected credit losses, loans to shareholders have been assessed on a collective basis as they possess shared credit risk characteristics. They have been grouped based on the days past due and also according to the geographical location of customers. The expected loss rates are based on the repayment profile over the past 48 months before 30 June 2019 as well as the corresponding historical credit losses during that period. The historical rates are adjusted to reflect current and forwarding looking factors affecting the customer’s ability to settle the amount outstanding. The group has identified liquidity in the Company’s shares to be the most relevant factor and adjusts loss rates for expected changes in these factors. However given the short period exposed to credit risk, the impact of these factors has not been considered significant within the reporting period. Loans to shareholders are written off (ie derecognised) when there is significant change in the share price of the Company and a likely change in the expectation of recovery. The reduction in the Company share price at 30 June 2019 and the failure to make payments at the loan due date and to engage with the Group on alternative payment arrangement amongst other is considered indicative of a reduced expectation of recovery. On the above basis the expected credit loss for the shareholder loan as at 30 June 2019 was determined as follows: Expected credit loss rate 0% 33% 100% Stage 1 $ Stage 2 $ Stage 3 $ Total $ - Gross carrying amount Lifetime expected credit loss - - 896,157 (300,000) - - 896,157 (300,000) g. Capital management policies and procedures The Group’s capital management objectives are: • To ensure the Group’s ability to continue as a going concern • To provide an adequate return to shareholders The Group monitors capital on the basis of the carrying amount of equity less cash and cash equivalents as presented on the face of the statement of financial position and cash flow. Management assesses the Group’s capital requirements in order to maintain an efficient overall financing structure while avoiding excessive leakage. The Group manages the capital structure and makes adjustments to it in the light of changes in economic conditions and the risk characteristics of the underlying assets. Consolidated Financial Statements for the Year Ended 30 June 2019 43 33. Fair value measurement 35. Subsequent events Fair value hierarchy The Group’s assets and liabilities measured or disclosed at fair value are valued using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurements date Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly Level 3: Unobservable inputs for the asset or liability There were no assets or liabilities held at fair value and no transfers between levels during the financial year. 34. Parent entity information Set out below is the supplementary information about Regeneus Ltd, the parent entity. Statement of financial position Current assets Total assets Current liabilities Total liabilities Net assets Issued capital Retained earnings Option reserve Total equity 2019 $ 2018 $ 2,384,591 2,541,714 8,752,923 8,928,309 (6,386,595) 31,076,819 4,312,874 4,983,029 1,818,607 2,061,364 2,921,665 31,076,819 (37,766,736) (29,774,604) 412,065 (6,386,595) 1,619,450 2,921,665 Statement of profit or loss and other comprehensive income Profit / (Loss) for the year Other comprehensive income (6,024,600) (5,184,600) - - Total comprehensive profit or (loss) (6,024,600) (5,184,600) In the period from 30 June 2019 through to the signing of the ﬁnancial report a number of important events have occurred: On 31 July 2019, AGC and Regeneus signed a variation to the joint venture agreements previously entered into, under which the parties acknowledge AGC has the right to terminate the joint venture arrangements and related agreements on the earlier of 31 December 2019 or such other date as may be agreed between the parties. Further, within 120 days of such termination AGC may elect to use US$2,500,000 of upfront and milestone payments previously paid to Regeneus to subscribe for shares in Regeneus at a fixed subscription price of AUD$0.16 per share. Upon such termination, RGS will acquire all of AGC’s shares in the joint venture at a price equal to 50% of the Company’s value as at 31 December 2018. On August 1 the Company made a private placement of 29,250,000 shares at 8 cents per share, which raised new capital of $2.34 million. The Company also announced a 1 for 6 rights issue which was partly underwritten by the conversion of $1.4 million of the Directors’ loans and Directors’ subscribing for a further $0.4 million of shares. On August 30 the Company announced the results of the non renounceable rights issue. 7,751,973 new shares were issues at 8 cents per share raising a further $620k. Additionally, as part of the underwriting arrangements entered into between the Company and some of its Directors in respect of this rights issue: 1 $1.4 million, previously loaned to the Company by these Directors in February 2019 (and which was repayable in March 2020), has been converted to 17.5 million ordinary shares, to be issued to these participating Directors (or related parties) at 8 cents per share; and an additional $400k has been contributed by some Directors in cash, with 5 million ordinary shares to be issued to these Directors (or related parties) under the rights issue at 8 cents per share. 2 The shortfall following the underwriting is 9,437,872 New Shares (Shortfall Shares). The directors of Regeneus reserve the right, subject to the requirements of the Corporations Act and the ASX Listing Rules, to place any Shortfall Shares within 3 months of the closing date at the Directors’ discretion and at a price not less than the Offer Price. Costs associated with these capital raising are not expected to exceed $300k. On August 13 the Company announced the implementation of strategic focus and cost containment activities. The outcome of these activities is the reduction in recurring operating costs to $250k per month. Further one off cash costs of implementation are expected to be less than $800k. Apart from the above, there are no other matters or circumstances that have arisen since the end of the year that have significantly affected or may significantly affect either the entity’s operations in future financial years, the results of those operations in future financial years or the entity’s state of affairs in future financial years. Consolidated Financial Statements for the Year Ended 30 June 2019 44 Directors’ declaration 1. In the opinion of the Directors of the Group: a. The consolidated financial statements and notes are in accordance with the Corporations Act 2001, including: i. Giving a true and fair view of its financial position as at 30 June 2019 and of its performance for the financial year ended on that date; and ii. Complying with Accounting Standards (including the Australian Accounting Interpretations) and the Corporations Regulations 2001; and b. There are reasonable grounds to believe that the Group will be able to pay its debts as and when they become due and payable. 2. The Directors have been given the declarations required by Section 295A of the Corporations Act 2001 from the chief executive officer and the chief financial officer for the financial year ended 30 June 2019. 3. Note 2 confirms that the consolidated financial statements also comply with International Financial Reporting Standards. Signed in accordance with a resolution of the Board of Directors: CEO and Executive Director Leo Lee Dated the 25th day of September 2019. Consolidated Financial Statements for the Year Ended 30 June 2019 45 Auditor’s Report 46 47 48 Additional shareholder information Additional information required by the ASX Limited Listing Rules and not disclosed elsewhere in this report is set out below. The information is effective 25 October 2019. Corporate governance statement In accordance with the ASX principles and recommendations, Regeneus Ltd’s corporate governance statements can be reviewed on the Company website at: regeneus.com.au/about-us/corporate- governance Buy back of shares There is no buy back of shares on offer Substantial shareholders The number of substantial shareholders and their associates are set out below: Shareholder Vesey Investments Mr Yao Lee Number of shares 14,399,642 13,511,000 Voting rights Buy back of shares There is no buy back of shares on offer Unissued equity securities Options issued under the options plans total 2,671,774 Ordinary shares On a show of hands, every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote. Options No voting rights Distribution of equity security holders Holding Shares Options 100,001 and over 10,001 to 100,000 5,001 to 10,000 1,001 to 5,000 1 to 1,000 235,803,410 2,671,774 29,744,702 2,040,221 788,461 10,322 - - - - 268,387,116 2,671,774 Unmarketable parcels 1,134,913 Consolidated Financial Statements for the Year Ended 30 June 2019 49 Ordinary shares Securities exchange Twenty largest shareholders Number held % of issued shares The Company was listed on the Australian Securities Exchange on 19 September 2013. Electronic communications Regeneus encourages shareholders to receive information electronically. Shareholders who currently receive information by post can log in at www.linkmarketservices.com.au to provide their email address and elect to receive electronic communications Electronic communications allows Regeneus to communicate with shareholders faster and reduce its use of paper. Cash usage Since listing on the ASX on 19 September 2013, the Group has used its cash and assets in a form readily converted to cash that it had at the time of admission to the official list of ASX in a manner consistent with its business objectives HSBC Custody Nominees Vesey Investments Pty Ltd Mr Yao Lee J P Morgan Nominees Australia Limited Mr Thomas Mechtersheimer SMC Capital Pty Ltd John Martin Mrs Julia Caroline Hughes MLB Holdings Pty Ltd Kensington Trust Singapore Ltd Shaun Sundberg Maximum (NQ) Pty Ltd Dr Marc Ronald Wilkins Citicorp Nominees Pty Limited Bubbling Wells Pty Ltd Mr Pierre Frederic Malou McGuire Family Holdings Pty Ltd Dr Benjamin Ross Herbert KBRoss Pty Ltd Bacau Pty Ltd Rose Martin Total Balance of register Grand total 18,346,500 14,399,642 13,511,000 11,226,673 6,133.433 5,216,726 4,384,682 3,748,942 3,500,000 3,125,000 3,125,000 3,041,666 2,985,161 2,513,456 2,500,000 2,376,538 2,050,000 2,013,973 2,000,000 1,940,732 1,863,642 6.84 5.37 5.03 4.18 2.29 1.94 1.63 1.40 1.30 1.16 1.16 1.13 1.11 0.94 0.93 0.89 0.76 0.75 0.75 0.72 0.69 110,002.,766 158,384,350 268,387,116 40.99 59.01 100.00 Consolidated Financial Statements for the Year Ended 30 June 2019 50 Registered Office and Principal Place of Business 2 Paddington St Paddington, NSW 2021 Board of Directors Barry Sechos (Non-executive Chairman) Leo Lee (Executive Director) Professor Graham Vesey (Executive Director) Dr. Glen Richards (Non-executive Director) Dr John Chiplin (Non-executive Director) Dr Alan Dunton (Non-executive Director) Company Secretary Sandra McIntosh Website regeneus.com.au Lawyers Dentons Australia Pty Ltd 77 Castlereagh Street Sydney NSW 2000 Auditors Grant Thornton Audit Pty Ltd Level 17, 383 Kent Street Sydney NSW 2000 Patent Attorneys Spruson & Ferguson Level 35, 31 Market Street Sydney, NSW 2000 Share Registry Link Market Services Limited Level 12, 680 George Street Sydney, NSW 2000 Stock Exchange Listing Australian Stock Exchange ASX Code: RGS Consolidated Financial Statements for the Year Ended 30 June 2019 51

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