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Immuron Ltd — Interim / Quarterly Report 2019
Feb 27, 2019
35121_rns_2019-02-27_7bb26a1f-59fc-4add-9414-4ba1159376ca.pdf
Interim / Quarterly Report
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Immuron Limited Appendix 4D Half-year 31 December 2018
| Immuron Limited Appendix 4D Half-year 31 December 2018 |
||||
|---|---|---|---|---|
| Name of entity: | Immuron Limited | |||
| ABN: | 80 063 114 045 | |||
| Half-year ended: | 31 December 2018 | |||
| Previous period: | 31 December 2017 | |||
| Results for announcement to the market | ||||
| $ | ||||
| Revenue for ordinary activities | Up | 6.4% | to | 978,233 |
| Net loss after tax (from ordinary activities) for the period attributable | ||||
| to members | Down | 16.4% | to | (1,581,899) |
| Net loss after tax for the period attributable to members | Down | 16.4% | to | (1,581,899) |
Net tangible assets per security
| Net tangible assets per security | ||||
|---|---|---|---|---|
| 31 | December | 31 | December | |
| 2018 | 2017 | |||
| Cents | Cents | |||
| Net tangible asset backing (per share) | 5.01 | 3.85 |
Explanation of results
An explanation of the key financial elements contributing to the revenue and result above can be found in the review of operations included within the directors' report.
Distributions
No dividends have been paid or declared by the Company for the current financial period. No dividends were paid for the previous financial period.
Changes in controlled entities
There have been no changes in controlled entities during the half-year 31 December 2018.
Other information required by Listing Rule 4.2A
| Other information required by Listing Rule 4.2A | |
|---|---|
| a. Details of individual and total dividends or distributions and dividend or distribution payments: | N/A |
| b. Details of any dividend or distribution reinvestment plans: | N/A |
| c. Details of associates and joint venture entities: | N/A |
| d. Other information | N/A |
Interim review
The financial statements have been reviewed by the Company's independent auditor without any modified opinion, disclaimer or emphasis of matters.
Immuron Limited ABN 80 063 114 045
Interim financial report for the half-year 31 December 2018
Immuron Limited ABN 80 063 114 045 Interim financial report - 31 December 2018
Contents
| Contents | |
|---|---|
| Page | |
| Corporate directory | 1 |
| Financial statements | |
| Directors' report | 3 |
| Directors | 3 |
| Review of operations | 3 |
| Auditor's independence declaration | 6 |
| Condensed consolidated statement of comprehensive income | 8 |
| Condensed consolidated balance sheet | 9 |
| Condensed consolidated statement of changes in equity | 10 |
| Condensed consolidated statement of cash flows | 11 |
| Notes to the condensed consolidated financial statements | 12 |
| Directors' declaration | 20 |
| Independent auditor's report to the members | 21 |
This interim financial report does not include all the notes of the type normally included in an annual financial report. Accordingly, this report is to be read in conjunction with the annual report for the year ended 30 June 2018 and any public announcements made by Immuron Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001 .
Immuron Limited Corporate directory
Directors
Secretary
Chief Executive Officer Registered Office
Principal Place of Business
Share Registry - United States
Share Registry - Australia
Auditor - Australia and United States
Solicitors - Australia
Dr. Roger Aston Independent Non-executive chairman Mr. Peter Anastasiou Executive vice chairman Mr. Daniel Pollock Independent non-executive director Mr. Stephen Anastasiou Independent non-executive director Prof. Ravi Savarirayan Independent non-executive director Mr. Richard Berman (appointed 1 July 2018) Independent non-executive director Mr. Phillip Hains Dr. Gary S Jacob (appointed 16 November 2018) Level 3, 62 Lygon Street Carlton VIC 3053 Australia Telephone: +61(0)3 9824 5254 Facsimile: +61(0)3 9824 5254 Unit 10, 25 - 37 Chapman Street Blackburn North VIC 3130 Australia Telephone: +61 (0)3 9824 5254 Facsimile: +61 (0)3 9822 7735 Bank of New York 225 Liberty Street New York, NY 102286 United States of America Telephone: +1 212 495 1784 Security Transfer Registrars Pty Ltd 770 Canning Highway Applecross WA 6153 Australia Telephone: +61 (0)8 9315 2333 Facsimile: +61 (08) 9315 2233 Grant Thornton Audit Pty Ltd Collins Square, Tower 5 727 Collins Street Melbourne VIC 3008 Australia Telephone: +61 (0)3 8320 2222 Francis Abourizk Lightowlers (FAL) Level 14, 114 William Street Melbourne VIC 3000 Australia Telephone: +61 (0)3 9642 2252
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Immuron Limited
Immuron Limited Corporate directory (continued)
Solicitors - United States
Bankers
Securities exchange listings
Websites
Carter Ledyard and Milburn LLP 2 Wall Street New York NY 10005 United States of America Telephone: +1 212 238 8605
Sheppard Mullin 30 Rockefeller Plaza New York NY 10112-0015 United States of America Telephone: +1 212 653 8700 National Australia Bank (NAB) 330 Collins Street Melbourne VIC 3000 Australia Australian Securities Exchange (Code: IMC) NASDAQ Exchange (Code: IMRN) www.immuron.com.au www.travelan.com.au
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Immuron Limited
Immuron Limited Directors' report 31 December 2018
Your Directors present their report on the consolidated entity consisting of Immuron Limited and the entities it controlled at the end of, or during, the half-year ended 31 December 2018.
Directors
The following persons held office as Directors of Immuron Limited during the financial period:
Dr. Roger Aston Mr. Peter Anastasiou Mr. Daniel Pollock Mr. Stephen Anastasiou Prof. Ravi Savarirayan
Mr. Richard Berman (appointed 1 July 2018)
Review of operations
Key highlights
-
Immuron announces two key senior appointments
-
Global Immuron Limited gross sales achieved a 7% year on year growth for the first half of FY19.
-
Immuron Canada Limited was successfully incorporated, and a Distribution and Sales agreement executed for the Canadian Market.
-
NASH Phase II Clinical Study Results presented at the American Association for the study of Liver Disease.
-
Severe Alcoholic Hepatitis Phase II trial closed, 56 patients recruited into the study and top line results anticipated to be reported Q2 2019.
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Paediatric NAFLD Phase II trial passes 50% recruitment milestone with recruitment of 23rd of targeted 40 patients
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Clostridium difficile infection trial - second clinical site at Sheba Medical Center in Israel open and screening patients. Feasibility and Australian site identification initiated to assist recruitment.
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US Department of Defence completes pre-clinical shigellosis challenge study in non-human primates and Reports Travelan® prevented clinical shigellosis (bacillary dysentery).
New York New York – New Board Member and New Chief Executive Officer
New York based Mr. Richard Jay Berman joined the Immuron Board in July 2018. Richard brings with him over 35 years of venture capital, senior management and merger & acquisition experience. Dr. Gary Jacob also New York based was appointed Chief Executive Officer in November 2018. Dr. Jacob’s is the former Co-founder, Chairman, President and Chief Executive Officer of Synergy Pharmaceuticals Inc. a Nasdaq-listed public biopharmaceutical company.
Travelan® enjoys continued sales growth
Immuron’s flag-ship product Travelan®, an over-the-counter travelers’ diarrhoea supplement, experienced steady sales growth in both Australian and U.S. markets throughout the first half of FY2019, with global gross sales reaching AU$1.083 million during the 6-month period. In the US, Travelan® sales grew by 10% to AU$369,000 in FY19 1H, as the brand continued to prosper via USA’s largest travel medicine provider, Passport Health. Growth of online sales on Amazon USA also contributed to this increase following a successful promotional campaign in December.
In Australia, Immuron sales reached AU$714,000 for 1H FY2019, with a 6% YoY growth rate. Travelan® continues to experience strong sales within Australia’s pharmacy network. A concerted marketing push to educate GPs and consumers about Travelan® will continue into 2H FY2019, including a program to improve the brand’s online footprint through a new global website and increased collaborations with the travel blogger community.
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Immuron Limited
Immuron Limited Directors' report 31 December 2018
(continued)
Review of operations (continued)
Travelan® enjoys continued sales growth (continued)
Immuron Canada Ltd was incorporated under the Canadian Business Corporations Act in April 2018. The associated Natural Product Number for Travelan® was officially transferred from former distributor Paladin Labs to Immuron Canada Limited in June 2018. A Distribution and Sales Agreement was executed with ANB Canada Inc in October 2018. The company this year announced that Health Canada has approved the product licence for Travelan®, paving the way to re-launch the product within Canada in April 2019. ANB Canada will manage the distribution and marketing of Travelan® within the Retail Pharmacy sector, whilst Passport Health will sell the product through their Canadian Travel Medicine Clinic network.
Travelan studies by US Department of Defense
Immuron provided an update on its cooperative research and development agreements with the US Department of Defense (US DoD) in July, which included three studies on Travelan®, the company’s commercially available flagship over-the-counter gastrointestinal and digestive health supplement. The studies aim to determine Travelan’s effectiveness in neutralizing pathogenic gastrointestinal bacterial infections as a preventative treatment for US military personnel stationed in locations where such infections may be debilitating.
The work completed at the US Armed Forces Research Institute of Medical Sciences, US Naval Medical Research Center and the Walter Reed Army Institute of Research (WRAIR) found Travelan® was effective across all strains and species of enteropathogenic bacteria tested. The specificity of antibodies incorporated into Travelan cross-react with multiple Campylobacter, ETEC and Shigella strains. The product is truly cross-reactive indicating a substantially broader spectrum of antimicrobial action than previously reported.
A preventative treatment that protects against enteric diseases, specifically Shigella, is a high priority objective for the US Army. Shigella is estimated to cause 80 -165 million cases of disease worldwide, resulting in 600,000 deaths annually and is particularly prevalent in both sub-Saharan Africa and South Asia.
In September 2018 we reported the findings of a study conducted by The US Armed Forces Research Institute of Medical Sciences (AFRIMS), an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR), located in Bangkok, Thailand. The study evaluated the therapeutic potential of TravelanÒ in a non-human primate (NHP) preclinical Shigella challenge model that closely mimics the disease seen in humans. The study was performed in collaboration with the Department of Enteric Diseases and the Department of Veterinary Medicine, AFRIMS, and the Department of Enteric Infections, Bacterial Diseases Branch, WRAIR.
As reported in September, Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated NHPs compared to placebo. A placebo-controlled study was carried out in 12 NHPs segregated into two groups: a Travelan® treatment cohort of 8 and a placebo cohort of 4, which were treated with either Travelan® or placebo respectively twice daily for a total of 12 doses over a 6-day period. The animals received treatment for 3-days prior to oral challenge with ~3 x 109 viable Shigella flexneri strain 2a organisms. All (4 of 4 - 100%) placebo-treated animals displayed acute dysentery symptoms within 24 - 36 hours of Shigella flexneri 2a challenge. A single (1 of 8 - 12.5%) of the Travelan®-treated cohort displayed dysentery symptoms at this time point. The remaining individuals (7 of 8 - 87.5%) in the Travelan® treatment cohort remained symptom-free to 4-days post Shigella flexneri 2a challenge. Once the treatment period concluded, a second individual in the Travelan treatment group developed symptoms (2 of 8 - 25%). The remainder (6 of 8 - 75%) of the Travelan® treated cohort remained symptom-free to the conclusion of the study 11-days post Shigella flexneri 2a challenge.
Immuron Limited
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Immuron Limited Directors' report 31 December 2018 (continued)
Review of operations (continued)
Shigella specific therapeutics
In July, Immuron announced it had once again engaged the services and facilities of the Commonwealth Scientific & Industrial Research Organisation (CSIRO) to produce three Shigella specific therapeutic products utilizing vaccines developed by the Walter Reed Army Institute of Research (WRAIR). Immuron received approval from Biosecurity Australia earlier last year to import the Shigella specific vaccines developed and produced by the WRAIR which were used to manufacture the products. The vaccination program was initiated in August last year and was completed in November. The hyperimmune colostrum from the study was harvested in December and the freeze-dried finished products should be available in Q1 CY2019 for shipment to the WRAIR for preclinical assessment. Under the current terms of the Cooperative Research Agreement, the WRAIR will fund the evaluation of the anti-Shigella therapeutics and assess their protective capacity in a head to head comparison with Travelan in established small animal models.
Fatty Liver Clinical Update
Topline results of our IMM-124E phase II Non-Alcoholic Steatohepatitis (NASH) clinical trial were reported in March 2018. Trial data demonstrated a significant reduction in serum lipopolysaccharide (LPS), as well as reductions in other biomarkers associated with liver damage. The company is presently focused on completing the final clinical study report, and is currently working with our contract research organization partners to complete final analysis of data generated, and any additional tests performed. The final clinical study report is expected to be completed early this year.
Clinical trial findings from the NASH trial were presented by Professor Arun Sanyal at the American Association for the study of Liver Disease which was held in San Francisco, California during the 9th - 13th of November 2018. The presentation entitled “IMM-124E Improves Metabolic Endotoxemia and Markers of Liver Injury in Non-Alcoholic Steatohepatitis” was presented during the Novel Therapeutics for NASH session. A copy of the final presentation is available on the company website.
Dr. Arun Sanyal is also lead Principal Investigator of our alcoholic steatohepatitis (“ASH”) clinical trial at Virginia Commonwealth University. The overall trial, funded by the NIH, has successfully recruited a total of 56 patients which have been randomized into the study. The trial is now closed to recruitment and the last patient last visit was completed in December 2018. Top-line results are expected to be reported in Q2 2019.
A second NIH-funded Phase II double-blind, placebo-controlled, randomized clinical trial of IMM-124E in paediatric non-alcholic fatty liver disease (NAFLD) patients is presently underway at Emory University, led by Dr. Miriam Vos, who specializes in the treatment of gastrointestinal disease in children, including NAFLD and obesity. The trial has presently randomized 23 of the targeted 40 patients into the study. The top-line results for this study are anticipated to be reported late this year.
NASH patents granted by European Patent Office
In July, the European Patent Office (EPO) granted Immuron a patent for the use of a composition for the treatment of Non-alcoholic steatohepatitis (NASH). This patent (EPO Grant No. 2424890) is entitled “Anti-LPS enriched immunoglobulin preparations for the treatment and/or prophylaxis of a pathologic disorder”. The patent comprises a total of five claims and is principally directed to a composition for use in the treatment of NASH with the composition comprising an enriched immunoglobulin preparation derived from colostrum and as developed by Immuron.
C. difficile infection update
A second clinical site at Sheba Medical Center in Israel was opened last year and is actively screening patients. The demographic for C. difficile infection in Israel seems mainly to be elderly patients with multiple co morbidities and dementia. To date, only 7 out of 60 patients have been randomized into the study, with the major issue facing enrollment at the two study sites continuing to be obtaining informed consent from patients. A formal feasibility and Australian site identification process has been initiated to assess new potential clinical investigators and sites to improve current recruitment rates.
Immuron Limited
5
Immuron Limited Directors' report 31 December 2018
(continued)
Review of operations (continued)
Pre-clinical program in Irritable Bowel Disease
In May we announced completion of the IMM-124 colitis preclinical program at the University of Zurich. The latest results were generated in the T cell transfer model which utilizes immunodeficient mice deficient in functional B and T lymphocytes. Chronic colitis is induced immunologically not chemically in this model. Macroscopically inflamed colons were confirmed in animals by colonoscopy prior to the initiation of treatment. IMM-124E was administered orally after the onset of colitis symptoms. The results revealed significant reductions in weight loss, disease activity scores, shortening of the colon, and macroscopically detectable colitis. These results mirror our NASH clinical study, which showed significant reductions in serum lipopolysaccharide (LPS) levels. LPS endotoxins are implicated as chief drivers of inflammation associated with colitis, inflammatory bowel disease and other autoimmune diseases. This research was presentation at the annual United European Gastroenterology Week conference held on the 20th - 24th of October 2018 in Vienna, Austria, and published in the European Journal of Crohn’s & Colitis a copy of which can be found on the company website.
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 7.
This report is made in accordance with a resolution of Directors.
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Dr. Roger Aston Independent Non-executive chairman
Melbourne 27 February 2019
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Immuron Limited
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Collins Square, Tower 5 727 Collins Street Melbourne Victoria 3008
Correspondence to: GPO Box 4736 Melbourne Victoria 3001
T +61 3 8320 2222 F +61 3 8320 2200 E [email protected] W www.grantthornton.com.au
Auditor’s Independence Declaration
To the Directors of Immuron Limited
In accordance with the requirements of section 307C of the Corporations Act 2001, as lead auditor for the review of Immuron Limited for the half year ended 31 December 2018, I declare that, to the best of my knowledge and belief, there have been:
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a no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and
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b no contraventions of any applicable code of professional conduct in relation to the audit.
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Grant Thornton Audit Pty Ltd Chartered Accountants
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M A Cunningham Partner – Audit & Assurance
Melbourne, 27 February 2019
Grant Thornton Audit Pty Ltd ACN 130 913 594 a subsidiary or related entity of Grant Thornton Australia Ltd ABN 41 127 556 389
www.grantthornton.com.au
‘Grant Thornton’ refers to the brand under which the Grant Thornton member firms provide assurance, tax and advisory services to their clients and/or refers to one or more member firms, as the context requires. Grant Thornton Australia Ltd is a member firm of Grant Thornton International Ltd (GTIL). GTIL and the member firms are not a worldwide partnership. GTIL and each member firm is a separate legal entity. Services are delivered by the member firms. GTIL does not provide services to clients. GTIL and its member firms are not agents of, and do not obligate one another and are not liable for one another’s acts or omissions. In the Australian context only, the use of the term ‘Grant Thornton’ may refer to Grant Thornton Australia Limited ABN 41 127 556 389 and its Australian subsidiaries and related entities. GTIL is not an Australian related entity to Grant Thornton Australia Limited.
Liability limited by a scheme approved under Professional Standards Legislation.
Immuron Limited Condensed consolidated statement of comprehensive income For the half-year 31 December 2018
| Notes Revenue from continuing operations Sales of goods 7 Total operating revenue Cost of goods sold Gross profit Direct selling costs Sales and marketing costs Freight costs Other income 7 Expenses Research and development Marketing and promotion Consulting, employee and director Other corporate administrative Travel and entertainment expenses Depreciation Finance fee costs Impairment of inventory Loss before income tax Income tax expense Loss from continuing operations Other comprehensive income Item that may be reclassified to profit or loss Exchange differences on translation of foreign operations 2(b) Total comprehensive loss for the period Blank Total comprehensive income for the period is attributable to: Owners of Immuron Limited Earnings per share for profit attributable to the ordinary equity holders of the Company: Basic loss per share 9 Diluted loss per share 9 |
Consolidated entity 31 December 2018 $ 31 December 2017 $ 978,233 919,138 |
|---|---|
| 978,233 919,138 (231,479) (195,356) |
|
| 746,754 723,782 (198,652) (145,150) (133,659) (89,125) |
|
| 414,443 489,507 |
|
| 310,436 1,387,039 (514,388) (1,540,436) (246,520) (238,192) (1,068,378) (815,232) (385,455) (829,999) (89,391) (174,987) (2,646) (2,277) - (3,767) - (163,600) |
|
| (1,581,899) (1,891,944) - - |
|
| (1,581,899) (1,891,944) |
|
| (112,270) 28,281 |
|
| (112,270) 28,281 |
|
| (1,694,169) (1,863,663) Cents Cents (1.2) (1.5) (1.2) (1.5) |
The above condensed consolidated statement of comprehensive income should be read in conjunction with the accompanying notes.
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Immuron Limited
Immuron Limited Condensed consolidated balance sheet As at 31 December 2018
| Notes ASSETS Current assets Cash and cash equivalents Trade and other receivables Inventories 8 Other current assets Total current assets Non-current assets Property, plant and equipment Inventories 8 Total non-current assets Total assets LIABILITIES Current liabilities Trade and other payables Employee benefit obligations Total current liabilities Total liabilities Net assets EQUITY Issued capital 2(a) Reserves 2(b) Accumulated losses Total equity |
Consolidated entity 31 December 2018 $ 30 June 2018 $ 4,190,259 4,727,430 643,206 1,683,305 530,495 497,902 239,695 141,800 |
|---|---|
| 5,603,655 7,050,437 |
|
| 17,737 20,384 2,075,683 2,171,867 |
|
| 2,093,420 2,192,251 |
|
| 7,697,075 9,242,688 |
|
| 403,521 689,326 117,713 114,012 |
|
| 521,234 803,338 |
|
| 521,234 803,338 |
|
| 7,175,841 8,439,350 |
|
| 58,442,043 58,372,043 2,756,727 2,606,722 (54,022,929) (52,539,415) |
|
| 7,175,841 8,439,350 |
The above condensed consolidated balance sheet should be read in conjunction with the accompanying notes. Immuron Limited 9
Immuron Limited Condensed consolidated statement of changes in equity For the half-year 31 December 2018
| Attributable to owners of | Attributable to owners of | |||
|---|---|---|---|---|
| Immuron Limited | ||||
| Accumulated | Total | |||
| Issued capital | Reserves | losses | equity | |
| Consolidated entity | $ | $ | $ | $ |
| Balance at 1 July 2017 | 53,632,995 | 2,470,417 | (49,528,486) | 6,574,926 |
| Loss for the period | - | - | (1,891,944) | (1,891,944) |
| Other comprehensive income | - | 28,281 | - | 28,281 |
| Total comprehensive income for the | ||||
| half-year | - | 28,281 | (1,891,944) | (1,863,663) |
| Transactions with owners in their capacity | ||||
| as owners: | ||||
| Contributions of equity, net of transaction costs | 213,396 | - | - | 213,396 |
| Options and warrants issued/expensed | - | 59,512 | - | 59,512 |
| 213,396 | 59,512 | - | 272,908 | |
| Balance at 31 December 2017 | 53,846,391 | 2,558,210 | (51,420,430) | 4,984,171 |
| Balance at 1 July 2018 as originally | ||||
| presented | 58,372,043 | 2,606,722 | (52,539,415) | 8,439,350 |
| Loss for the period | - | - | (1,581,899) | (1,581,899) |
| Other comprehensive income | - | (112,270) | - | (112,270) |
| Total comprehensive income for the | ||||
| half-year | - | (112,270) | (1,581,899) | (1,694,169) |
| Transactions with owners in their capacity | ||||
| as owners: | ||||
| Contributions of equity, net of transaction costs | 70,000 | - | - | 70,000 |
| Options and warrants issued/expensed | - | 360,660 | - | 360,660 |
| Lapse of unexercised options | - | (98,385) | 98,385 | - |
| 70,000 | 262,275 | 98,385 | 430,660 | |
| Balance at 31 December 2018 | 58,442,043 | 2,756,727 | (54,022,929) | 7,175,841 |
The above condensed consolidated statement of changes in equity should be read in conjunction with the accompanying notes.
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Immuron Limited
Immuron Limited Condensed consolidated statement of cash flows For the half-year 31 December 2018
Condensed consolidated statement of cash flows
| Notes Cash flows from operating activities Receipts from customers (inclusive of GST) Payments to suppliers and employees (inclusive of GST) Interest received Other - R&D tax concession refund and other government grants Interest and other costs of finance paid Net cash outflow from operating activities Cash flows from investing activities Payments for property, plant and equipment Net cash outflow from investing activities Cash flows from financing activities Repayment of borrowings Capital raising costs Net cash outflow from financing activities Net (decrease) in cash and cash equivalents Cash and cash equivalents at the beginning of the financial year Effects of exchange rate changes on cash and cash equivalents Cash and cash equivalents at end of the half-year |
Consolidated entity 31 December 2018 $ 31 December 2017 $ 1,138,524 1,184,856 (2,753,669) (4,367,410) 39 43 1,190,205 - - (3,767) |
|---|---|
| (424,901) (3,186,278) |
|
| - (2,180) |
|
| - (2,180) |
|
| - (243,950) - (1,934) |
|
| - (245,884) |
|
| (424,901) (3,434,342) 4,727,430 3,994,924 (112,270) 28,281 |
|
| 4,190,259 588,863 |
The above condensed consolidated statement of cash flows should be read in conjunction with the accompanying notes.
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Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018
1 Segment and revenue information
(a) Description of segments
The entity has identified its operating segments based on the internal reports that are reviewed and used by the executive management team in assessing performance and determining the allocation of resources.
The executive management team considers the business from both a product and a geographic perspective and has identified three reportable segments.
Research and Income and expenses directly attributable to the Company’s research and development Development (R&D) projects performed in Australia, Israel and United States.
HyperImmune Income and expenses directly attributable to Travelan activities which occur in Australia, Products New Zealand, US and Canada. In 2018, the Company earned 67%, 1% and 32% of its revenues from customers located in Australia, Canada and US, respectively. In 2017, the Company earned 66%, 0% and 34% of its revenues from customers located in Australia, Canada and US, respectively.
(b) Segment results
| Consolidated entity 31 December 2018 Segment revenue and other income Revenue from external customers R&D tax concession refund Interest income Segment revenue and other income Segment expenses Depreciation and amortisation Share-based payments Other operating expenses Segment expenses Income tax expense (Loss)/Profit for the period Segment assets Total assets Segment liabilities Total liabilities |
Research & Development HyperImmune Products Unallocated Corporate Total $ $ $ $ - 978,233 - 978,233 310,166 - - 310,166 - - 270 270 |
|---|---|
| 310,166 978,233 270 1,288,669 |
|
| - - (5,047) (5,047) - - (360,660) (360,660) (403,521) (563,790) (1,537,550) (2,504,861) |
|
| (403,521) (563,790) (1,903,257) (2,870,568) |
|
| - - - - |
|
| (93,355) 414,443 (1,902,987) (1,581,899) 310,990 2,718,889 4,667,196 7,697,075 |
|
| 310,990 2,718,889 4,667,196 7,697,075 |
|
| (71,903) (11,974) (437,357) (521,234) |
|
| (71,903) (11,974) (437,357) (521,234) |
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Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018 (continued)
1 Segment and revenue information (continued)
(b) Segment results (continued)
| (b) Segment results (continued) | ||
|---|---|---|
| Consolidated entity 31 December 2017 Segment revenue and other income Revenue from external customers R&D tax concession refund Interest income Other income Total segment revenue and other income Segment expenses Depreciation and amortisation Finance costs Share-based payments Other operating expenses Total segment expenses Income tax expense (Loss)/Profit for the period Segment assets Total assets Segment liabilities Total liabilities 2 Equity securities issued (a) Issued capital Fully paid (i) Movements in ordinary shares: Details Opening balance 1 July 2018 Shares issued during the year Balance 31 December 2018 |
Research & Development HyperImmune Products Unallocated Corporate Total $ $ $ $ - 919,138 - 919,138 1,386,790 - - 1,386,790 - - 43 43 - 206 - 206 |
|
| 1,386,790 919,344 43 2,306,177 |
||
| - - (2,277) (2,277) - - (3,767) (3,767) - - (59,512) (59,512) (1,540,436) (429,631) (2,162,498) (4,132,565) |
||
| (1,540,436) (429,631) (2,228,054) (4,198,121) |
||
| - - - - |
||
| (153,646) 489,713 (2,228,011) (1,891,944) 2,884,901 2,536,093 736,997 6,157,991 |
||
| 2,884,901 2,536,093 736,997 6,157,991 |
||
| (481,023) (154,886) (537,911) (1,173,820) |
||
| (481,023) (154,886) (537,911) (1,173,820) |
||
| -$2,250,232 -$2,870,920 $2,028,925 -$3,092,227 31 December 2018 No. 31 December 2018 $ 30 June 2018 No. 30 June 2018 $ 143,215,706 58,442,043 142,778,206 58,372,043 Note Number of shares Total $ 142,778,206 58,372,043 437,500 70,000 143,215,706 58,442,043 |
||
| 143,215,706 58,442,043 |
(ii) Rights of each type of share
Ordinary shares entitle the holder to participate in dividends and the proceeds on winding up of the company in proportion to the number of shares held. On a show of hands every holder of ordinary shares present at a meeting or by proxy, is entitled to one vote. upon a poll every holder is entitled to one vote per share held. The ordinary shares have no par value.
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Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018
(continued)
2 Equity securities issued (continued)
(b) Reserves
The following table shows a breakdown of the balance sheet line item ‘other reserves’ and the movements in these reserves during the period. A description of the nature and purpose of each reserve is provided below the table.
| Consolidated entity At 1 July 2018 Options/warrants issued during the year Lapse of unexcercised options Other comprehensive loss for the period At 31 December 2018 |
No. of Options Qty Amount $ Foreign currency translation $ Total other reserves $ 71,349,180 2,650,039 (43,317) 2,606,722 3,300,000 360,660 - 360,660 (50,000) (98,385) - (98,385) - - (112,270) (112,270) |
|---|---|
| 74,599,180 2,912,314 (155,587) 2,756,727 |
3 Share-based payments
The following share-based payment arrangements were entered into during the half-year 31 December 2018 due to new options granted and vested:
| Grant date | Expiry date Balance at start | Expiry date Balance at start | Exercise | Balance at | |||
|---|---|---|---|---|---|---|---|
| of year | price ($) | Granted | Exercised | Vested | end of year | ||
| . | |||||||
| 02-Jul-2018 | 01-Jul-2021 | - | 0.50 | 1,300,000 | - | 1,300,000 | 1,300,000 |
| 19-Nov-2018 | 30-Jun-2020 | - | 0.50 | 2,000,000 | - | 2,000,000 | 2,000,000 |
For the options granted during the half-year 31 December 2018, the valuation model inputs used to determine the fair value at the grant date are outlined below:
| Grant date | Expiry date | Share price at | Exercise | Expected | Dividend | Risk-free | Fair value at |
|---|---|---|---|---|---|---|---|
| grant date ($) | price ($) | volatility | yield | interest rate | grant date ($) | ||
| . | |||||||
| 02-Jul-2018 | 01-Jul-2021 | 0.32 | 0.50 | 92% | 0% | 2.09% | 204,100 |
| 19-Nov-2018 | 30-Jun-2020 | 0.28 | 0.50 | 92% | 0% | 2.02% | 164,400 |
4 Contingencies
The Company had no contingent liabilities and at 31 December 2018 (2017: nil).
5 Events occurring after the reporting period
No other matter or circumstances has arisen since 31 December 2018 that has significantly affected, or may significantly affect the Group's operations, the results of those operations, or the Group's state of affairs in future financial years.
14
Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018 (continued)
6 Related party transactions
(a) Transactions with other related parties
The following transactions occurred with related parties:
| The following transactions occurred with related parties: | ||
|---|---|---|
| Premises rental services received from Wattle Laboratories Pty Ltd to Immuron Limited: |
31 December 2018 |
31 December 2017 |
| Wattle Laboratories Pty Ltd (Wattle) is an entity part-owned and operated by Immuron Directors Peter and Stephen Anastasiou. Commencing on 1 January 2016, Immuron executed a Lease Agreement with Wattle whereby Immuron will lease part of their Blackburn office facilities for Immuron's operations at an arms-length commercial rental rate of $38,940 per annum, payable in monthly instalments. The rental agreement is subject to annual rental increases, and effective 1 January 2017, the annual rent was increased to $39,525. The lease is for a 3 year term with an additional 3 year option period. The lease is cancellable by either party upon 6 months written notice of termination of the agreement. |
||
| Rental fees paid to Wattle Laboratories Pty Ltd during the year through the issue of equity: |
$Nil | $Nil |
| Total paid by the Company to Wattle Laboratories Pty Ltd during the year: |
$22,151 | $9,881 |
| At the period end the Company owed Wattle Laboratories Pty Ltd: | $17,374 | $Nil |
15
Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018
(continued)
6 Related party transactions (continued)
(a) Transactions with other related parties (continued)
| (a) Transactions with other related parties (continued) | ||
|---|---|---|
| Service rendered by Grandlodge Capital Pty Ltd to Immuron Ltd: | 31 December 2018 |
31 December 2017 |
| Grandlodge Capital Pty Ltd (Grandlodge) is an entity part-owned and operated by Immuron Directors Peter and Stephen Anastasiou. Mr David Plush is also an owner of Grandlodge, and its associated entities. Grandlodge, and its associated entities, are marketing, warehousing and distribution logistics companies. Commencing on 1 June 2013, Grandlodge was contracted on commercial market arms-length terms to provide warehousing, distribution and invoicing services for Immuron’s products for $70,000 per annum. These fees will be payable in new fully paid ordinary shares in Immuron Limited at a set price of $0.16 per share representing Immuron Limited’s share price at the commencement of the agreement. The shares to be issued to Grandlodge, or its associated entities, as compensation in lieu of cash payment for the services rendered under this agreement have been subject to the approval of Immuron shareholders at Company shareholder meetings held over the past 18 months. Grandlodge will also be reimbursed in cash for all reasonable costs and expenses incurred in accordance with their scope of works under the agreement, unless both parties agree to an alternative method of payment. The agreement is cancellable by either party upon providing the other partywith 30 days written notice of the termination of the agreement. |
||
| Service fees paid to Grandlodge Pty Ltd during the year through the issue of equity: |
$70,000 | $140,000 |
| Totalpaid by the Company to Grandlodge Pty Ltd during theyear: | $70,000 | $Nil |
| At the period end the Company owed Grandlodge Pty Ltd: | $Nil | $Nil |
7 Revenue
The Company derives the following types of revenue:
| Revenue from operating activities Sales of good Less: discounts and rebates Total revenue from operating activities Other income Interest on financial assets held as investments Other items R&D tax concession refund Total other income |
Consolidated entity 31 December 2018 $ 31 December 2017 $ 1,083,805 1,010,919 (105,572) (91,781) |
|---|---|
| 978,233 919,138 |
|
| 39 43 231 207 310,166 1,386,789 |
|
| 310,436 1,387,039 |
16
Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018 (continued)
8 Inventories
| 8 Inventories |
|
|---|---|
| Raw materials - Colostrum Work in progress Finished goods - Travelan and Protectyn Total of inventories classified under current asset Colostrum Inventory - Non Current Total of inventories classified under non-current asset |
Consolidated entity 31 December 2018 $ 30 June 2018 $ 294,769 198,585 - 33,625 235,726 265,692 |
| 530,495 497,902 |
|
| Consolidated entity 31 December 2018 $ 30 June 2018 $ 2,075,683 2,171,867 |
|
| 2,075,683 2,171,867 |
There was no impairment of inventories recognised during financial year 2018 (2017: $163,600 for stock obsolescence in the Statement of Profit or Loss and Other Comprehensive Income.
During the current financial period, management have performed an assessment on its raw materials and its utilisation within 12 months from reporting date and have determined $294,769 of raw materials relating to Colostrum will be consumed within 12 months and remaining balance of $2,075,683 will be consumed after 12 months from reporting date.
9 Loss per share
(a) Basic/diluted loss per share
| (a) Basic/diluted loss per share | |
|---|---|
| From continuing operations attributable to the ordinary equity holders of the company (b) Reconciliation of earnings used in calculating earnings per share Basic/diluted loss per share Loss attributable to the ordinary equity holders of the Company used in calculating basic/diluted earnings per share: From continuing operations |
Consolidated entity 31 December 2018 Cents 31 December 2017 Cents (1.2) (1.5) |
| Consolidated entity 31 December 2018 $ 31 December 2017 $ (1,581,899) (1,891,944) |
17
Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018
(continued)
9 Loss per share (continued)
(c) Weighted average number of shares used as denominator
| Consolidated | entity |
|---|---|
| 2018 | 2017 |
| Number | Number |
Weighted average number of ordinary shares used as the denominator in calculating basic/diluted loss per share 136,365,586 130,086,505
The Company is currently in a loss making position and thus the impact of any potential shares is concluded as anti-dilutive which includes the Company's options and Convertible Note payable and warrants. Treasury shares are excluded from the calculation of weighted average number of ordinary shares.
10 Basis of preparation of half-year report
This condensed consolidated interim financial report for the half-year reporting period ended 31 December 2018 have been prepared in accordance with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Act 2001 .
These interim report does not include all the notes of the type normally included in an annual financial report. Accordingly, this report is to be read in conjunction with the annual report for the year ended 30 June 2018 and any public announcements made by Immuron Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001 .
The accounting policies adopted are consistent with those of the previous financial year and corresponding interim reporting period and the adoption of the new and amended standards as set out below. The Interim Financial Statements have been approved and authorised for issue by the board on 27 February 2019.
(a) New and amended standards adopted by the Company
A number of new or amended standards became applicable for the current reporting period and the Company had to change its accounting policies and applying the modified retrospective method where required as a result of adopting the following standards:
-
AASB 9 Financial Instruments , and
-
AASB 15 Revenue from Contracts with Customers .
The impact of the adoption of these standards and the new accounting policies are disclosed in note below. The other standards did not have any impact on the Company's accounting policies and did not require retrospective adjustments.
(b) Impact of new and amended standards adopted by the Company
(i) AASB 9 Financial Instruments
AASB 9 Financial Instruments replaces AASB 139 Financial Instruments: recognition and measurement requirements. It makes major changes to the previous guidance on the classification and measurement of financial assets and introduces an 'expected credit loss' model for impairment of financial assets.
While this represents significant new guidance, the implementation of the new guidance did not have a material impact on trade receivables. As such, the Company has elected not to restate prior periods and have not recognised differences in opening retained earnings as at 1 July 2018.
(ii) AASB 15 Revenue from Contracts with Customers
The Company has adopted AASB 15 Revenue from Contracts with Customers from 1 July 2018 which did not result in changes in the accounting policies and adjustments to the amounts recognised in the financial statements.
18
Immuron Limited
Immuron Limited Notes to the condensed consolidated financial statements 31 December 2018
(continued)
10 Basis of preparation of half-year report (continued)
(c) Impact of standards issued but not yet applied by the entity
(i) AASB 16 Leases
AASB 16 was issued in February 2016. It will result in almost all leases being recognised on the balance sheet, as the distinction between operating and finance leases is removed. Under the new standard, an asset (the right to use the leased item) and a financial liability to pay rentals are recognised. The only exceptions are short-term and low-value leases.
The standard will affect primarily the accounting for the group’s operating leases. As at the reporting date, the group has non-cancellable operating lease commitments of $39,525. However, the group has not yet determined to what extent these commitments will result in the recognition of an asset and a liability for future payments and how this will affect the group’s profit and classification of cash flows.
The standard is mandatory for first interim periods within annual reporting periods beginning on or after 1 January 2019. The Company does not intend to adopt the standard before its effective date.
(d) Changes in accounting policies
(I) AASB 9 Financial Instruments – Accounting policies applied from 1 January 2018 Impairment of financial assets
For trade receivables under AASB 9 the Company applies a simplified approach of recognising lifetime expected credit losses as these items do not have a significant financing component.
(II) AASB 15 Revenue from Contracts with Customers – Accounting policies applied from 1 January 2018 Revenue is earned from the sale of Travelan and Protectyn.
The Company ’s revenue from contracts with customers arise from the sale of goods within Australia, USA and other world markets, through a variety of avenues including pharmacies, clinics and the internet.
Based on the Company’s revenue recognition process and the nature of the Company’s revenue stream from contracts with customers, the Company recognises revenue at a point in time when the performance obligation is satisfied upon the delivery of goods to customers.
11 Summary of significant accounting policies
(a) Going concern
Some of the risks inherent in the development of pharmaceutical products include the uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development or may infringe intellectual property rights of other parties, and obtaining the necessary drug clinical regulatory authority approvals. Furthermore, a particular project may fail the research and the clinical development process through lack of efficacy or safety, or may be stopped or abandoned due to strategic imperatives including an assessment that the projects will not deliver a sufficient return on investment or have been superseded by newer competitive products or technologies. There is a risk that the Company will be unable to find suitable development or commercial partners for its projects, and that these arrangements may not generate a material return for the Company.
Based on current budget forecast assumptions, the Company is in a position to meet future commitments in the current business cycle and pay its debts as and when they fall due. Furthermore, the Company is able to progress its research and development programs for at least the next 12 months.
The interim financial report has been prepared on a going concern basis. Accordingly, the interim financial report does not include adjustments relating to the recoverability and classification of recorded asset amounts, or the amounts and classification of liabilities that might be necessary should the Company not continue as a going concern.
19
Immuron Limited
Immuron Limited Directors' declaration 31 December 2018
In the Directors' opinion:
-
(a) the financial statements and notes set out on pages 8 to 19 are in accordance with the Corporations Act 2001 , including:
-
(i) complying with Accounting Standards AASB 134 Interim Financial Reporting, the Corporations Regulations 2001 and other mandatory professional reporting requirements, and
-
(ii) giving a true and fair view of the consolidated entity's financial position as at 31 December 2018 and of its performance for the half-year ended on that date, and
-
(b) there are reasonable grounds to believe that the Immuron Limited will be able to pay its debts as and when they become due and payable.
This declaration is made in accordance with a resolution of Directors.
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Dr. Roger Aston Director
Melbourne 27 February 2019
20
Immuron Limited
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Collins Square, Tower 5 727 Collins Street Melbourne Victoria 3008
Correspondence to: GPO Box 4736 Melbourne Victoria 3001
T +61 3 8320 2222 F +61 3 8320 2200 E [email protected] W www.grantthornton.com.au
Independent Auditor’s Review Report
To the Members of Immuron Limited
Report on the review of the half year financial report
Conclusion
We have reviewed the accompanying half year financial report of Immuron Limited (the Company) and its subsidiaries (the Group), which comprises the consolidated statement of financial position as at 31 December 2018, and the consolidated statement of comprehensive income, consolidated statement of changes in equity and consolidated statement of cash flows for the half year ended on that date, a description of accounting policies, other selected explanatory notes, and the directors’ declaration.
Based on our review, which is not an audit, nothing has come to our attention that causes us to believe that the half year financial report of Immuron Limited does not give a true and fair view of the financial position of the Group as at 31 December 2018, and of its financial performance and its cash flows for the half year ended on that date, in accordance with the Corporations Act 2001 , including complying with Accounting Standard AASB 134 Interim Financial Reporting .
Directors’ responsibility for the half year financial report
The Directors of the Company are responsible for the preparation of the half year financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the Directors determine is necessary to enable the preparation of the half year financial report that gives a true and fair view and is free from material misstatement, whether due to fraud or error.
Auditor’s responsibility
Our responsibility is to express a conclusion on the half year financial report based on our review. We conducted our review in accordance with Auditing Standard on Review Engagements ASRE 2410 Review of a Financial Report Performed by the Independent Auditor of the Entity , in order to state whether, on the basis of the procedures described, we have become aware of any matter that makes us believe that the half year financial report is not in accordance with the Corporations Act 2001 including giving a true and fair view of the Group’s financial position as at 31 December 2018 and its performance for the half year ended on that date, and complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001 . As the auditor of Immuron Limited, ASRE 2410 requires that we comply with the ethical requirements relevant to the audit of the annual financial report.
Grant Thornton Audit Pty Ltd ACN 130 913 594 a subsidiary or related entity of Grant Thornton Australia Ltd ABN 41 127 556 389
www.grantthornton.com.au
‘Grant Thornton’ refers to the brand under which the Grant Thornton member firms provide assurance, tax and advisory services to their clients and/or refers to one or more member firms, as the context requires. Grant Thornton Australia Ltd is a member firm of Grant Thornton International Ltd (GTIL). GTIL and the member firms are not a worldwide partnership. GTIL and each member firm is a separate legal entity. Services are delivered by the member firms. GTIL does not provide services to clients. GTIL and its member firms are not agents of, and do not obligate one another and are not liable for one another’s acts or omissions. In the Australian context only, the use of the term ‘Grant Thornton’ may refer to Grant Thornton Australia Limited ABN 41 127 556 389 and its Australian subsidiaries and related entities. GTIL is not an Australian related entity to Grant Thornton Australia Limited.
Liability limited by a scheme approved under Professional Standards Legislation.
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A review of a half year financial report consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Independence
In conducting our review, we have complied with the independence requirements of the Corporations Act 2001.
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Grant Thornton Audit Pty Ltd Chartered Accountants
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M A Cunningham Partner – Audit & Assurance
Melbourne, 27 February 2019