AI assistant
Immuron Ltd — Interim / Quarterly Report 2017
Feb 27, 2017
35121_rns_2017-02-27_28f8ebe0-0777-404f-aa80-458a94e1b4a7.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
==> picture [298 x 83] intentionally omitted <==
Appendix 4D For the Half Year Ended 31 December 2016
Current Reporting Period – Half Year Ended 31 December 2016
Previous Reporting Period – Half Year Ended 31 December 2015
This report is to be read in conjunction with the 30 June 2016 Annual Report and is given in compliance with Listing Rule 4.2A.
| 31 Dec 2016 31 Dec 2015 |
31 Dec 2016 31 Dec 2015 |
31 Dec 2016 31 Dec 2015 |
|
|---|---|---|---|
| Revenues Up 41% to 703,099 from 497,220 Loss after tax attributable to members UP 45% to (3,409,349) from (2,354,743) Net loss for the period attributable to members UP 45% to (3,409,349) from (2,354,743) |
|||
| Net Tangible Asset per Security (cents per security) As at 31 December 2016 3.363 As at 31 December 2015 2.540 |
|||
| Dividends (distribution) | Amount per Security | Franked Amount per Security |
|
| Current period | n/a | n/a | |
| Previous corresponding period | n/a | n/a | |
| Record date for determining entitlements to dividend n/a Details of dividend reinvestment plans in operation None Details of entities over which control has been gained or lost during the period None Details of Associates and Joint Ventures None These accounts have been subject to review and there has been no qualification or dispute. Explanation of the above information: Refer to the Directors' Report - Review of Operations. Approved Date: Tuesday, 28thFebruary 2017 |
==> picture [298 x 83] intentionally omitted <==
Appendix 4D Interim Financial Report
For the Half Year Ended 31 December 2016
==> picture [355 x 341] intentionally omitted <==
To be read in conjunction with the 30 June 2016 Annual Report. In compliance with Listing Rule 4.2A
These financial statements have not been reviewed under US Public Company Accounting Oversight Board (PCAOB) audit standards
==> picture [90 x 16] intentionally omitted <==
Page 2 of 24
ASX:IMC
Contents
| Directors’ Report | 4 |
|---|---|
| Auditor’s Independence Declaration | 9 |
| Consolidated Statement of Profit or Loss and Other Comprehensive Income | 10 |
| Consolidated Statement of Financial Position | 11 |
| Consolidated Statement of Changes in Equity | 12 |
| Consolidated Statement of Cash Flows | 13 |
| Notes to the Financial Statements | 14 |
| Directors’ Declaration | 21 |
| Independent Auditors’ Review Report | 22 |
| Company Directory | 24 |
This Half Year Financial Report does not include all notes of the type normal included in an Annual Financial Report. Accordingly, this report is to be read in conjunction with the Annual Financial Report for the year ended 30 June 2016 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 and the ASX Listing Rules.
Directors’ Report
Your Directors present their report on Immuron Limited for the half year ended 31 December 2016.
Directors
The following persons were directors of Immuron Limited and its entity it controls during the whole of the halfyear and up to the date of this report, unless otherwise stated:
Dr. Roger Aston Non-Executive Chairman Mr. Peter Anastasiou Deputy Executive Vice Chairman Mr. Stephen Anastasiou Non-Executive Director Mr. Daniel Pollock Non-Executive Director
Key Highlights
-
Completion of the NASH Phase II Trial Recruitment – 120 Patients Randomized
-
New NIH Grant, Studies, and NASH LM&A Activity Further Validate Potential of the NASH Program
-
Travelan and Protectyn Continue to Grow – 42% Growth in Global Net Sales
-
Immuron Signs Significant Development and Collaboration Agreements with US Army and US Navy
-
Immuron Preparing for IMM-529 Phase 1/2 Clinical Trials in Clostridium difficile
-
Partnership Formed with Australian Research Institutes on Autism Studies
-
Oversubscribed $6.32M Rights Issue & $1.6M FY2016 R&D Refund
-
Immuron files F1 with the US Securities and Exchange Commission ahead of NASDAQ listing
Completion of the NASH Phase II Clinical Trial Recruitment – 120 Patients Randomized
Changes to the clinical trial protocol has allowed Immuron to significantly accelerate the recruitment of the NASH Phase II clinical trial. We were pleased to announce on 20[th] February that the NASH Phase II clinical trial has now been fully recruited with 120 patients successfully randomized.
The Company expects to have interim results in CY2Q 2017 and the top line results of the trial by the CY4Q2017.
New NIH Grant, Studies, and NASH LM&A Activity Further Validate Potential of the NASH Program
The potential of Immuron’s non-alcoholic steatohepatitis (NASH) candidate, IMM-124E, was further highlighted by:
-
the success in securing another NIH grant for a Phase II study in Pediatric NAFLD/NASH patients,
-
the start of additional Mechanism of Action (MOA) studies of IMM-124E in NASH; and
-
the continued robustness of the NASH LM&A (Licensing Merger & Acquisition) market.
1. Pediatric NAFLD/NASH Trial
In August 2016, the US National Institutes of Health (NIH), America’s foremost medical research agency, awarded Atlanta’s prestigious Emory University with a grant to conduct a Phase II clinical study of IMM124E in pediatric NAFLD/NASH patients.
==> picture [90 x 16] intentionally omitted <==
Page 4 of 24
ASX:IMC
Directors’ Report (Continued…)
This is the second NIH grant supporting an Immuron IMM-124E study in fatty-liver disease, with the first study being the ongoing Phase II ASH (Alcoholic SteatoHepatitis) study conducted by the University of Virginia.
The Pediatric NAFLD/NASH grant was classified in the top one percent of all NIH grant requests in one of the most fiercely contested funding environments in the world. The awarding of this grant highlights the importance that the NIH is placing on the unmet needs of pediatric patients in NASH and on IMM-124E’s Mechanism of Action (MOA) study, as well as the potential for another blockbuster indication for Immuron.
Pediatric NASH is believed to affect between three (3) to five (5) percent of the US pediatric population. A landmark autopsy study also showed that of 742 youths aged 15 to 19 who had died in accidents, 17.3 percent had NAFLD (non-alcoholic fatty liver disease).
With no approved treatments available, the pediatric NASH indication for IMM-124E is a $billion+ potential market opportunity for Immuron.
2. New IMM-124E MOA NASH Studies
In early 2017, we initiated MOA studies which are designed to add to the growing body of evidence supporting the unique multifactorial MOA of IMM-124E in NASH. These studies are being conducted in partnership with SanyalBio and Duke University in the United States.
We expect the results of these studies to be available by the end of CY2017, which will also coincide with the release of the top line results from the Company’s Phase II NASH clinical trial. These studies will help support our business development efforts.
3. LM&A NASH Market
In October 2016, we saw the $US1.7 billion takeover proposal of Tobira Pharmaceuticals by Allergan. The acquisition was structured with a ~US$311M upfront payment, which was 3.5x Tobira’s market cap at the time of the announcement. This is despite the fact that Tobira’s Phase II did not reach its primary endpoint. The bid skyrocketed Tobira’s market capitalization from US$89.2 million to US$725 million in a day.
On November 1, 2016, Allergan closed its acquisition of Tobira for US$538M which equate to a 500% premium over Tobira’s market cap at the time of the announcement of the acquisition.
Travelan and Protectyn Sales Experience 42% Growth
Travelan Net Sales for the first 6 months of FY2017 increased by 40% compared to the same period last year. This performance was predominantly driven by a 157% increase in United States Sales, a 4% increase in Australian sales.
In the United States, the strong relationship we have developed with Passport Health Corporate is powering our sales growth. Our partnership with Passport Health Corporate meant that Travelan has been available at more than 80 clinics throughout the US and a successful promotional campaign during the August 2016 – December 2016 period resulted in several thousand packets of Travelan being sold to Passport Health customers. The key behind this success was the training of Passport Health’s nurses who carried Travelan’s differentiation message to their customers. This performance was particularly impressive given that this was the non-travel season.
==> picture [90 x 16] intentionally omitted <==
Page 5 of 24
ASX:IMC
Directors’ Report (Continued…)
Based on the success of this promotion, Passport Health Corporate and Immuron will again combine to run another promotional campaign for the March 2017 – August 2017 peak US travel period. Immuron will also seek to partner with several Passport Health independent clinics to drive our performance further.
Immuron also entered into an agreement with Medique Products, one of the largest distributors of medical supplies in the US, including OTCs, for workplace health. Medique targets occupational health nurses, industrial supply, occupational health doctors, corporate safety directors, correctional health, school health and sports medicine. Medique has over 40 years’ experience distributing medical and OTCS through a network of more than 1,000 business partners across the US.
In June 2016, Magellan’s added Travelan to it monthly US travel products catalogue and placed its first purchase order. With 1.5 million subscribers, mostly affluent international travelers, the profile of this distributor is ideal for Travelan. Magellan is also part of the Potpourri Group, one of North America’s largest multi-brand, multichannel retailers.
In Australia, the first 6 months of the 2017 financial year continued to maintain the increasing trend in sales growth we recorded last year. We have planned additional trade and promotional activities in the second half of this financial year to further accelerate our growth in Australia.
In Canada, Immuron is currently in negotiation with Paladin to terminate the current marketing and distribution agreement with a goal of taking back the regulatory, marketing and distribution rights for Canada and other territories, including Central and Latin America.
- Immuron Preparing for IMM 529 Phase 1/2 Clinical Trials in Clostridium difficile
Following IMM-529’s exciting results in pre-clinical studies, Immuron has been preparing for the start of the safety/efficacy clinical trials in humans. Immuron is currently finalizing the manufacturing of IMM-529’s clinical supplies and has finalized a protocol for 60 patients that will be conducted at a major center. We estimate that the trial should commence in CY2Q2017, and will take approximately 12 months to recruit.
We are excited by the progress we are making and we look forward to continue pushing forward the development IMM-529 in Clostrium difficile infections (CDI), a blockbuster orphan indication that kills nearly 30,000 people each year in the US and is a growing problem around the world.
Immuron Signs Significant Development and Collaboration Agreements with US Army and US Navy
The US military has executed two research and development collaboration agreements with Immuron which further highlights the growing respect the US military has for Immuron’s anti-infective platform.
The first agreement, signed in June 2016, is for the development of a Shigella vaccine with the Walter Reed Army Institute of Research (WRAIR). Shigella bacteria causes Shigellosis, or bacillary dysentery, affecting around 165 million people a year and causing a million deaths annually, mostly children in developing countries. Shigella currently has no approved vaccines.
Now in its 125[th] year, WRAIR is the oldest, largest, and most diverse military biomedical research institute in the US Department of Defense. This research program will explore the anti- Shigella activity of antibodies in Travelan, and look to create a Shigella -specific bovine immunoglobulin product using WRAIR antigens utilizing Immuron’s oral immunotherapy platform.
==> picture [90 x 16] intentionally omitted <==
Page 6 of 24
ASX:IMC
Directors’ Report (Continued…)
The second agreement was executed in August 2016 with the US Navy’s Navy Medical Research Center. This research program will test Travelan in cell lines of Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
Campylobacter and ETEC are the bacteria behind most cases of traveler’s diarrhea around the world. Conservative estimates claim ETEC alone causes approximately 157,000 deaths a year, mainly in children. No vaccines exist to counter either strain of bacteria. If we are successful, this could potentially open a new and lucrative opportunity for Immuron with resulting products produced to meet both military and civilian needs.
Partnership Formed with Australian Research Institutes on Autism Studies
In July 2016, Immuron announced a cutting edge collaboration partnership with three leading Australian research institutes. The research will explore connections between gastrointestinal (GI) microbiota and people with Autism Spectrum Disorder (ASD).
The partnering research institutes include the University of Melbourne, La Trobe University, and the Murdoch Children’s Research Institute.
This research program will initially concentrate on microbiota in mouse models, which is similar to humans, but will allow for more control over environmental factors which can be difficult in human testing.
Data from the study will be an industry first and could eventually lead to human studies. These would support the increasingly convincing research that links the microbiome to certain Central Nervous System (CNS) conditions.
Oversubscribed $6.32M Rights Issue & $1.6M FY2016 R&D Refund
Immuron’s July 2016 Rights Issue closed in Sept 2016, and was oversubscribed raising $6.32 million (before costs).
As a result, the Company was able to inform shareholders that it would repay all future Convertible Note repayments to US Investment Fund Sea Otter in cash, benefiting shareholders through no further dilution of their holdings via share issue repayments.
Immuron also received a $1.6 million cash refund from its $3.6m of eligible research and development (R&D) expenditure in financial year 2016 under the Australian Federal Government’s Research and Development Income Tax Concession incentive program.
Immuron Files F-1 with the US Securities and Exchange Commission ahead of NASDAQ Listing
In December 2016, the Company filed its Registration Statement Form F-1 with the US Securities and Exchange Commission (SEC). The registration is the first step towards an initial public offering (IPO) in the United States of Immuron’s American Depository Shares (ADS) on the US NASDAQ exchange. Following the endorsement of shareholders in Nov 2016 for the US NASDAQ listing, the Company has continued to progress the listing as quickly as practicable.
In February 2017, the Company submitted two rounds of responses to queries it has received from the SEC. The Company will continue to work with the SEC to satisfy all requests for clarification to ensure the Form F1 is finalized as soon as possible.
==> picture [90 x 16] intentionally omitted <==
Page 7 of 24
ASX:IMC
Directors’ Report (Continued…)
On the horizon
Looking forward for the remainder of fiscal year 2017, there are a number significant milestones on the horizon:
-
Completion of Registration with the US SEC;
-
US listing on NASDAQ via IPO and associated capital raising;
-
Progression of NASH, Pediatric NAFLD/NASH and ASH programs;
-
Top Line results of the NASH Phase II clinical trial interim analysis;
-
Commencement of the Phase I/II C. difficile clinical trial program; and
-
Acceleration of the colitis pre-clinical program;
All of these developments underpin the careful planning and strategic thinking that continues to guide Immuron’s advance towards global significance as a pharmaceutical force, and a NASH-centric LM&A transaction post NASH Phase II results to ensuring the Company is maximizing the potential value from its portfolio platform for shareholders.
For and on behalf of the Company
==> picture [114 x 48] intentionally omitted <==
Thomas Liquard Chief Executive Officer Immuron Limited
Dated: This the 28[th] day of February 2017
==> picture [90 x 16] intentionally omitted <==
Page 8 of 24
ASX:IMC
Auditors’ Independence Declaration
==> picture [470 x 666] intentionally omitted <==
==> picture [90 x 15] intentionally omitted <==
Page 9 of 24
ASX:IMC
Consolidated Statement of Profit or Loss and Other
Comprehensive Income
For the Half Year Ended 31 December 2016
| 31 December 2016 31 December 2015 |
|
|---|---|
| Notes $ (Restated) $ |
|
| Revenue Total Operating Revenue 703,099 497,220 |
|
| Total Operating Revenue 703,099 497,220 Cost of Goods Sold (223,394) (153,640) |
|
| Gross Profit 479,705 343,580 Direct Selling Costs Sales and Marketing Costs (93,520) (242,150) Freight Costs (62,590) (61,299) |
|
| Total Gross Revenue 323,595 40,131 Other Income 816,932 1,476,906 Expenses Consulting, Employee and Director (907,390) (1,113,214) Corporate Administration (790,103) (708,625) Depreciation (1,975) (1,944) Finance Fee Costs (13,183) - Impairment of Inventory (135,170) (169) Marketing and Promotion (471,735) (12,233) Research and Development (2,117,867) (1,839,990) Travel and Entertainment (112,453) (195,605) |
|
| Loss Before Income Tax (3,409,349) (2,354,743) |
|
| Income Tax Expense - - |
|
| Loss after income tax for the period (3,409,349) (2,354,743) |
|
| Other comprehensive income: Items that will not be reclassified to profit or loss Exchange differences on translatingforeign operations (41,425) (4,781) |
|
| Total Comprehensive Loss for the period (3,450,774) (2,359,524) |
|
| Basic/Diluted Loss per Share (cents per share) 7 (3.318) (3.120) |
The above Consolidated Statement of Profit or Loss and Other Comprehensive Income should be read in conjunction with the accompanying notes.
==> picture [90 x 15] intentionally omitted <==
Page 10 of 24
ASX:IMC
Consolidated Statement of Financial Position
For the Half Year Ended 31 December 2016
| 31 December 2016 30 June 2016 |
|
|---|---|
| Notes $ (Restated) $ |
|
| ASSETS Current Assets Cash and cash equivalents 3,103,683 2,290,639 Trade and other receivables 900,347 4,387,772 Inventories 1,751,871 2,056,067 Other 81,933 74,943 |
|
| Total Current Assets 5,837,834 8,809,421 |
|
| Non-Current Assets Property, plant and equipment 17,967 18,063 |
|
| Total Non-Current Assets 17,967 18,063 |
|
| TOTAL ASSETS 5,855,801 8,827,484 |
|
| LIABILITIES Current liabilities Trade and other payables 1,624,621 1,986,407 Borrowings - 772,397 Other financial liabilities 678,000 1,128,117 |
|
| Total Current Liabilities 2,302,621 3,886,921 |
|
| TOTAL LIABILITIES 2,302,621 3,886,921 |
|
| NET ASSETS 3,553,180 4,940,563 |
|
| EQUITY Issued capital 5 47,485,700 45,633,354 Reserves 2,243,061 2,128,566 Retained earnings (46,175,581) (42,821,357) |
|
| TOTAL EQUITY 3,553,180 4,940,563 |
The above Consolidated Statement of Financial Position should be read in conjunction with the accompanying notes.
==> picture [90 x 15] intentionally omitted <==
Page 11 of 24
ASX:IMC
Consolidated Statement of Changes in Equity
For the Half Year Ended 31 December 2016
| Share Capital Option Reserves Foreign Currency Translation Reserve Accumulated Losses Total |
|
|---|---|
| $ $ $ $ $ |
|
| Balance as at 30 June 2015 40,335,347 560,646 (12,581) (37,542,572) 3,340,840 |
|
| Loss after income tax expense for the year - - - (2,359,524) (2,359,524) Other comprehensive loss for theperiod - - (4,781) - (4,781) |
|
| Total comprehensive loss for the period - - (4,781) (2,359,524) (2,364,305) |
|
| Employee and consultant share options - 537,309 - - 537,309 Lapse or exercise of share options - (58,615) - - (58,615) Transactions with owners in their capacity as owners Shares issued,net of costs 480,879 - - - 480,879 |
|
| Balance as at 31 December 2015 (Restated) 40,816,226 1,039,340 (17,362) (39,902,096) 1,936,108 |
|
| Balance as at 30 June 2016 (Restated) 45,633,354 2,132,302 (3,736) (42,821,357) 4,940,563 |
|
| Loss after income tax expense for the year - - - (3,409,349) (3,409,349) Other comprehensive loss for theperiod - - (41,425) - (41,425) |
|
| Total comprehensive loss for the period - - (41,425) (3,409,349) (3,450,774) |
|
| Options issued/expensed - 282,920 - - 282,920 Lapse or exercise of share options 71,875 (127,000) - 55,125 - Transactions with owners in their capacity as owners Shares issued,net of costs 1,780,471 - - - 1,780,471 |
|
| Balance as at 31 December 2016 47,485,700 2,288,222 (45,161) (46,175,581) 3,553,180 |
The above Consolidated Statement of Changes in Equity should be read in conjunction with the accompanying notes.
==> picture [90 x 16] intentionally omitted <==
Page 12 of 24
ASX:IMC
Consolidated Statement of Cash Flows
For the Half Year Ended 31 December 2016
| 31 December 2016 31 December 2015 |
|
|---|---|
| Note $ $ |
|
| Cash flows Related to Operating Activities Receipts from customers 664,900 613,528 Payments to suppliers and employees (4,423,797) (4,074,918) Interest received 6,791 7,143 Interest and other costs of finance paid (54,555) - Other - R&D Tax Concession Refund 1,590,043 - |
|
| Net Cash Flows Used In Operating Activities (2,216,618) (3,454,247) |
|
| Cash Flows Related to Investing Activities Payment for purchases of plant and equipment (1,879) (2,441) |
|
| Net Cash Flows Used In Investing Activities (1,879) (2,441) |
|
| Cash Flows Related to Financing Activities Proceeds from issues of securities 4,423,234 342,223 Capital raising costs (120,285) (7,458) Proceeds from borrowings - 1,000,000 Repayment of borrowings 8 (1,271,555) - |
|
| Net Cash Flows Used In Financing Activities 3,031,394 1,334,765 |
|
| Net increase/(decrease) in cash and cash equivalents 812,897 (2,121,923) Cash and cash equivalents at the beginning of the period 2,290,639 3,116,074 Effects of exchange rate changes on cash and cash equivalents 147 - |
|
| Cash and Cash Equivalents at the End of the Period 3,103,683 994,151 |
The above Consolidated Statement of Cash Flows should be read in conjunction with the accompanying notes.
==> picture [90 x 15] intentionally omitted <==
Page 13 of 24
ASX:IMC
Notes to the Financial Statements
Note 1. Basis of Preparation
(a) Basis of Preparation
The general purpose financial report for the interim half year reporting period ended 31 December 2016 has been prepared in accordance with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Act 2001.
This half year financial report does not include all 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 2016 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 and the ASX Listing Rules.
Compliance with AASB 134 "Interim Financial Report" ensures that the financial statements and notes of the entity comply with International Financial Reporting Standards equivalent IAS 34 "Interim Financial Reporting."
(b) Accounting Policies
All accounting policies adopted are consistent with the most recent Annual Financial Report for the year ended 30 June 2016. The consolidated entity has adopted all of the new, revised or amending Accounting Standards and Interpretation issued by the Australian Accounting Standards Board (‘AASB’) that are mandatory for the current reporting period. The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the consolidated entity.
(c) Fair value measurement
Due to the nature of the Group’s operating profile, the Directors and management do not consider that the fair values of the Group’s financial assets and liabilities are materially different from their carrying amounts at 31 December 2016.
(d) Going Concern
At 31 Dec 2016 the Company’s cash and cash equivalents amounted to $3,103,683 (2015: $994,151).
For the half year ended 31 December 2016 the Company experienced a net cash outflow of $2,216,618 (2015: $3,454,247) from operating activities. This included $2,117,867 of expenditures associated with research, development and commercialisation programs predominantly surrounding the Non- Alcoholic Steatohepatitis (NASH) Clinical Trial.
The Company has achieved a number of key successes in the past 6 months including:
-
successfully completion of an oversubscribed $6.32M Right Issue Capital Raising (before costs);
-
Repayment of convertible note in cash so as to remove downward pressure on share price from the selloff of conversion shares;
-
completion and Filing of the Form F1 with SEC in preparation of a US NASDAQ listing;
-
commencement of HIN fully-funded IMM-124E Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD) Phase II trial; and
-
completion of patient recruitment in the Company’s (NASH) IMM-124E Phase II clinical trial.
Whilst the Company is projecting further net losses and a net cash outflow from operations for the remainder of the 2017 financial year, the Board is confident of strong support from US investors ahead of the highly anticipated US NASDAQ listing.
==> picture [90 x 15] intentionally omitted <==
Page 14 of 24
ASX:IMC
Notes to the Financial Statements (Continued…)
The Directors have considered feedback from advisors as well as the considerable recent US market activity surrounding NASH clinical assets, which when combined with the forthcoming NASH clinical trial results pending for release in Q4 of 2017, the Company is very well positioned to ensure a successful fund raising can be achieved.
In the unlikely event that the Company is not successful with the US NASDAQ IPO raise, the Company may seek to raise further funds through more conventional means via the ASX. The likelihood of the Company not being able to raise further funding to secure it future as a going concern is extremely minimal, but should this occur the Company would amend its current business plans and targets in the interim.
Accordingly, the Directors have prepared the financial statements on a going concern basis. As such, the financial statements do not include any adjustments as to the recoverability and classification of recorded asset amounts or to the amounts and classification of liabilities that might be necessary should the entity not continue as a going concern.
Note 2. Dividends
The company has not declared any dividends in the period ended 31 December 2016. (2015: $Nil)
Note 3. Segment Information
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.
Segments
Research and Development (R&D) – Income and expenses directly attributable to the company’s research and development projects performed in Australia and Israel.
HyperImmune Products – Income and expenses directly attributable to Travelan activities which occur in Australia, New Zealand and United States.
Corporate – Other items of income and expenses not directly attributable to R&D or HyperImmune Products segment are disclosed as corporate costs. Corporate activities primarily occur within Australia. This segment includes interest expenses from financing activities and depreciation.
The Board assesses the performance of the operating segments at a number of operating levels including adjusted EBITDA.
==> picture [90 x 15] intentionally omitted <==
Page 15 of 24
ASX:IMC
Notes to the Financial Statements (Continued…)
| Research & HyperImmune Corporate |
|||
|---|---|---|---|
| 31 December 2016 | Development Products |
Total | |
| $ $ $ |
$ | ||
| Segment Revenue Revenue from external customers R&D tax concession refund Interest revenue Other revenue |
- 703,099 - 779,826 - - - - 6,791 25,007 - 5,308 |
703,099 779,826 6,791 30,315 |
|
| Total Segment Revenues | 804,833 703,099 12,099 |
1,520,031 | |
| Segment Expenses Segment Expenses |
(2,117,867) (379,504) (2,432,009) |
(4,929,380) | |
| Total Segment Expenses | (2,117,867) (379,504) (2,432,009) |
(4,929,380) | |
| Income Tax Expenses | - - - |
- | |
| Net Result | (1,313,034) 323,595 (2,419,910) |
(3,409,349) | |
| Assets Segment assets |
702,623 1,949,595 3,203,583 |
5,855,801 | |
| Total Assets | 702,623 1,949,595 3,203,583 |
5,855,801 | |
| Liabilities Segment liabilities |
(708,474) (131,630) (1,462,517) |
(2,302,621) | |
| Total Liabilities | (708,474) (131,630) (1,462,517) |
(2,302,621) | |
| Research & HyperImmune Corporate |
|||
| 31 December 2015 | Development Products |
Total | |
| $ $ $ |
$ | ||
| Segment Revenue Revenue from external customers R&D tax concession refund Interest revenue |
- 497,220 - 1,469,763 - - - - 7,143 |
497,220 1,469,763 7,143 |
|
| Total Segment Revenues | 1,469,763 497,220 7,143 |
1,974,126 | |
| Segment Expenses Segment Expenses |
(1,839,990) (457,089) (2,031,790) |
(4,328,869) | |
| Total Segment Expenses (Restated) | (1,839,990) (457,089) (2,031,790) |
(4,328,869) | |
| Income Tax Expenses | - - - |
- | |
| Net Result (Restated) | (370,227) 40,131 (2,024,647) |
(2,354,743) | |
| Assets Segment assets |
1,469,763 1,597,215 1,078,817 |
4,145,795 | |
| Total Assets | 1,469,763 1,597,215 1,078,817 |
4,145,795 | |
| Liabilities Segment liabilities |
(642,521) (52,486) (1,509,901) |
(2,204,908) | |
| Total Liabilities | (642,521) (52,486) (1,509,901) |
(2,204,908) |
==> picture [90 x 15] intentionally omitted <==
Page 16 of 24
ASX:IMC
Notes to the Financial Statements (Continued…)
Note 4. Contingent Liabilities and Assets
There has been no change in contingent liabilities and assets since the last annual reporting date.
Note 5. Contributed Equity
| 31 December 2016 30 June 2016 |
|
|---|---|
| No. $ No. $ |
|
| Fully Paid Ordinary Shares Balance at beginning of year 80,099,646 45,633,354 74,964,232 40,335,347 Shares issued during the year 25,541,771 1,841,951 5,135,414 1,721,789 Shares to be issued - - - 4,511,378 Movement to Retained Earnings - 71,875 - - Treasury Shares - - - (800,000) Transactions costs - (61,480) - (135,160) |
|
| Total Contributed Equity 105,641,417 47,485,700 80,099,646 45,633,354 |
During the Half Year ended 31 December 2016 the Company issued the following Ordinary Shares:
| Date | Details | Issue Price | Total Value | |
|---|---|---|---|---|
| No. | $ | $ | ||
| 7 Jul 2016 | Right Issue | 25,289,894 | 0.072 |
1,811,096 |
| 2 Dec 2016 | Shares under ESOP - for 6 month service (vesting | 251,877 |
0.123 |
30,855 |
| monthly) | ||||
| Total 2016 Movement | 25,541,771 | 1,841,951 |
Note 6. Option Reserves
| 31 December 2016 30 June 2016 |
|
|---|---|
| No. $ No. $ |
|
| Options over Fully Paid Ordinary Shares Balance at beginning of year 8,937,629 2,132,302 6,188,676 560,646 Options issued during the year 26,489,894 70,520 1,425,532 285,600 Options exercised during the year - - (1,060,166) (71,875) Expense of vested options - 212,400 6,000,000 1,606,275 Lapse of unexercised options (1,250,000) (127,000) (3,616,413) (248,344) |
|
| Total Reserves 34,177,523 2,288,222 8,937,629 2,132,302 |
During the Half Year ended 31 December 2016 the Company issued the following Options:
| Date | Issue Price | Total Value | ||
|---|---|---|---|---|
| No. | $ | $ | ||
| 2 Dec 2016 | Right Issue | 25,289,894 | - |
- |
| 9 Dec 2016 | Unlisted Option in lieu of services | 1,000,000 | 0.042 |
41,900 |
| 9 Dec 2016 | Unlisted Option in lieu of services | 200,000 | 0.143 |
28,620 |
| Total 2016 Movement | 26,489,894 | 70,520 |
==> picture [90 x 15] intentionally omitted <==
Page 17 of 24
ASX:IMC
Notes to the Financial Statements (Continued…)
Note 7. Loss Per Share
| 31 December 2016 | 31 December 2015 |
||
|---|---|---|---|
| (Restated) | |||
| $ | $ | ||
| Basic/Diluted loss per share (cents) | (3.318) | (3.120) |
|
| a) | Net loss used in the calculation of basic and diluted loss per share |
(3,409,349) |
(2,354,743) |
| Weighted average number of ordinary shares outstanding | 102,756,793 |
75,470,006 |
|
| b) | during the period used in the calculation of basic and diluted | ||
| loss per share |
Note 8. Related Party Transactions
Short-Term Loan
Grandlodge Capital Pty Ltd (Grandlodge) is an entity part-owned and operated by Immuron Directors Peter and Stephen Anastasiou. On 6[th] June 2016, Immuron executed a short-term funding agreement with Grandlodge for a principle amount of $750,000, plus associated arms-length commerical establishment and interest charges.
The short-term funding is a cash advance against the anticipated refund Immuron will receive from the Australian Taxation Office under the Research and Development Income Tax Concession Incentive for the Company's eligible R&D expenditure incurred for financial year of 2016.
Loan has been repaid to Grandlodge on 2[nd] December 2016.
Service rendered by Grandlodge Pty Ltd to Immuron Ltd
Grandlodge, and its associated entities, are marketing, warehousing and distribution logistics companies which is part-owned and operated by Immuron Limited’s Executive Vice Chairman Peter Anastasiou and Non-Executive Director Stephen Anastasiou. Mr David Plush is also an owner of Grandlodge, and its associated entities, and owns a top 20 shareholding in Immuron Limited.
Commencing on 1[st] 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 party with 30 days written notice of the termination of the agreement.
==> picture [90 x 15] intentionally omitted <==
Page 18 of 24
ASX:IMC
Notes to the Financial Statements (Continued…)
Premises Rental services received from Wattle Laboratories Pty Ltd to Immuron Ltd:
Wattle Laboratories Pty Ltd (Wattle) is an entity part-owned and operated by Immuron Directors Peter and Stephen Anastasiou. Commencing on 1[st] 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 lease is for a 3 year term with an additional 1 year option period.
The lease is cancellable by either party upon 6 months written notice of termination of the agreement.
Note 9. Events Occurring after the Reporting Date
There have not been any matters or circumstances in the financial statements or notes thereto, that have arisen since the end of the financial half year, which significantly affected, or may significantly affect, the operations of Immuron Limited, the results of those operations or the state of affairs of Immuron Limited in future financial years.
Note 10. Adjustment to previously lodged financial statements.
Unlisted Options Adjustment:
Subsequent to the issue of the financial statements for the period ended 30 June 2016, for the purpose of the US NASDAQ filing process, management reviewed and re-assessed it’s estimates surrounding the accounting treatment applied to the valuation of Unlisted Options issued in lieu of cash payment during the FY2016 financial year for additional services as per Resolution 5A-5D of the AGM held on 25 Nov 2015.
The financial statements for the 30 June 2016 valued the Options using the recommended and accepted Black‐ Scholes methodology for determining the fair value of the options in accordance with AASB 2– Share Based Payments. The Company re-assessed the underlying assumptions and estimates surrounding the original Black and Scholes inputs and it was determined that the original volatility input of 42%, was too low. Accordingly, the Company has recalculated the value of the Unlisted Options using the Black and Scholes model including a volatility input of 100% which has effectively increased the share based payment expense associated with the Unlisted Options. This difference in this valuation pertaining to the FY2016 portion of the Unlisted Option expense has been subsequently recorded in the FY2016 financial period effectively restating the original FY2016 presented numbers.
The impact on the Consolidated Statement of Comprehensive Income and Consolidated Balance Sheet were accordingly restated, as follows:
| Amounts Reported | Amounts reported | ||
|---|---|---|---|
| on ASX | Adjustment | in these financial | |
| 31 December 2015 | Recognised |
statements | |
| $ | $ | $ | |
| Consolidated Statement of Profit and Loss | |||
| and Other Comprehensive Income | |||
| Consulting,Employee and Director | (675,139) | (438,075) | (1,113,214) |
| Loss after income tax for theperiod | (1,916,668) | (438,075) | (2,354,743) |
| Consolidated Statement of Financial | |||
| Position | |||
| Reserves | 583,902 | 438,076 |
1,021,978 |
| Retained Earning | (39,459,241) | (438,076) |
(39,897,317) |
==> picture [90 x 15] intentionally omitted <==
Page 19 of 24
ASX:IMC
Notes to the Financial Statements (Continued…)
| Amounts Reported | Amounts reported | ||
|---|---|---|---|
| on ASX | Adjustment | in these financial | |
| 30 June 2016 | Recognised | statements | |
| $ | $ | $ | |
| Consolidated Statement of Profit and Loss | |||
| and Other Comprehensive Income | |||
| Consulting, Employee and Director | (1,630,700) | (1,209,337) |
(2,840,037) |
| Loss after income tax for the period | (4,389,667) | (1,209,337) |
(5,599,004) |
| Consolidated Statement of Financial | |||
| Position | |||
| Issued Capital* | 46,505,229 | 871,875 |
45,633,354 |
| Reserves | 847,353 | (1,281,213) |
2,128,566 |
| Retained Earning | (41,612,019) | 1,209,338 |
(42,821,357) |
*A re-classification of Escrowed Treasury Shares previously recorded as an Asset has resulted in a $800,000 reduction in the Company’s Assets and a corresponding increase in Company’s equity reserves.
| EPS | EPS | ||
|---|---|---|---|
| 31 December | 2015 | 30 June 2016 | |
| $ | $ | ||
| Earnings per share | |||
| EPS as reported on ASX | 2.540 | 5.705 |
|
| EPS reported in these financial statements | 3.120 | 7.277 |
==> picture [90 x 15] intentionally omitted <==
Page 20 of 24
ASX:IMC
Directors’ Declaration
The directors of the company declare that:
-
The financial statements and notes, as set out on pages 10 to 20, are in accordance with the Corporations Act 2001 and other mandatory professional reporting requirements including:
-
(a) complying with Accounting Standard AASB 134: Interim Financial Reporting and the Corporations Regulations; and
-
(b) giving a true and fair view of the consolidated entity's financial position as at 31 December 2016 and of its performance for the half-year ended on that date
-
In the Directors' opinion there are reasonable grounds to believe that the company 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 the Board of Directors.
==> picture [92 x 28] intentionally omitted <==
Dr. Roger Aston Non-Executive Chairman Immuron Limited
This the 28[th] Day of February 2017
==> picture [90 x 15] intentionally omitted <==
Page 21 of 24
ASX:IMC
Independent Auditor’s Review Report
==> picture [470 x 670] intentionally omitted <==
==> picture [90 x 15] intentionally omitted <==
Page 22 of 24
ASX:IMC
Independent Auditor’s Review Report (Continued…)
==> picture [470 x 669] intentionally omitted <==
==> picture [90 x 15] intentionally omitted <==
Page 23 of 24
ASX:IMC
Company Directory
Australian Company Number (ACN) 063 114 045
Immuron Limited is a Public Company Limited by shares and is domiciled in Australia.
Directors
Dr. Roger Aston Mr. Peter Anastasiou Mr. Stephen Anastasiou Mr. Daniel Pollock
Chief Executive Officer (CEO)
Mr. Thomas Liquard
Principal Place of Business
Unit 10, 25-37 Chapman Street, Blackburn North, Victoria, 3130 Australia Telephone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735 Share Registry Security Transfer Registrars 770 Canning Highway Applecross WA 6153 Telephone: +61 (0)8 9315 2333 Facsimile: +61 (0)8 9315 2233
Auditors
William Buck Level 20, 181 William Street Melbourne, Victoria, 3000 Australia Telephone: + 61 (0)3 9824 8555 Facsimile: + 61 (0)3 9824 8580
Non-Executive Chairman Deputy Executive Vice Chairman Non-Executive Director Non-Executive Director
Company Secretaries
Mr. Phillip Hains Mr. Peter Vaughan
Registered Office
Suite 1, 1233 High Street Armadale, Victoria, 3143 Australia Telephone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735
Solicitors
Francis Abourizk Lightowlers Level 16, 356 Collins Street Melbourne, Victoria, 3000 Australia
Bankers
National Australia Bank (NAB) 330 Collins Street, Melbourne, Victoria, 3000 Australia
Websites
www.immuron.com www.travelan.com.au
Securities Quoted
Australian Securities Exchange
- Ordinary Fully Paid Shares (Code: IMC)
==> picture [90 x 15] intentionally omitted <==
Page 24 of 24
ASX:IMC