Full Press Release Details
Interim Financial Report
For the Half-Year Ended
(previous corresponding period: half-year ended 31 December 2011)
To be read in conjunction with the 30 June 2012 Annual Report.
In compliance with Listing Rule 4.2A
ASX/Media Release (ASX: PRR)
Appendix 4D Interim Financial Report
Results for Announcement to the Market
Current Reporting Period
Half-year Ended 31 December 2012
Previous Reporting Period Half-year Ended 31 December 2011
| Revenues | Down | 100 | % | to | Nil | |||||||||||
| Loss after tax attributable to members | Down | 13.78 | % | to | ($ | 8,030,406 | ) | |||||||||
| Net loss for the period attributable to members | Down | 13.78 | % | to | ($ | 8,030,406 | ) |
| Dividends (Distribution) | Amount per Security | Franked Amount per Security | ||||||
| Final dividend | n/a | n/a | ||||||
| Previous corresponding period | n/a | n/a | ||||||
| Record date for determining entitlements to the dividend, (in the case of a trust, distribution) | n/a |
| Net Tangible Assets per Share (cents) | ||||
| As at 31 December 2012 | 2.74 | |||
| As at 31 December 2011 | 4.47 |
Explanation of the above information:
Refer to the Directors Report - Review of Operations.
| Directors Report | 2 | |||
| Auditor s Independence Declaration | 4 | |||
| Consolidated Statement of Comprehensive Income | 5 | |||
| Consolidated Balance Sheet | 6 | |||
| Consolidated Statement of Changes in Equity | 7 | |||
| Consolidated Statement of Cash Flows | 8 | |||
| Notes to the Financial Statements | 9 | |||
| Directors Declaration | 17 | |||
| Independent Auditor s Review Report to the Members | 18 |
Your directors are pleased to provide the
following half-year report on Prima Biomed Ltd and its subsidiaries (referred to hereafter as the Group or Prima or the Company) for the half-year ended 31 December 2012.
The following persons were directors of Prima during the whole of the half-year
and up to the date of this report unless otherwise stated:
Ms Lucy Turnbull, AO (Non-executive Chairman)
Mr Albert Wong (Non-executive Deputy Chairman and Chair of Audit Committee)
Dr Richard Hammel (Non-executive Director and Chair of Remuneration Committee)
Mr Martin Rogers (CEO and Executive Director until 31 August 2012; Non-executive Director from 01 September 2012)
Mr Matthew Lehman (COO and Executive Director until 31 August 2012; CEO and Executive Director from 01 September 2012)
Review of Operations
pleased to report continued strong progress in the development of CVac for epithelial ovarian cancer. In the six months to December 31, 2012, the Company incurred a net loss of $8,030,406; the majority of these funds have been invested into the
manufacturing and clinical development of CVac.
During the past half-year, Prima has refined its strategy to capitalize on its leadership position in developing personalized immunocellular therapeutics for cancer. Key to the clinical and commercial
success of products such as CVac, and what we consider the long-term driver of value in Prima, is the establishment of a robust global supply, logistics, and manufacturing platform. This platform, combined with robust clinical data from ongoing
trials, would put Prima in a strong position to negotiate potential partnerships for commercializing CVac in the future. It also provides us multiple opportunities for value creation, including the ability to look at other immunocellular therapies
to bring into our development pipeline.
Prima s past investment in our technology, operational platform, and product development has
given us a significant competitive advantage in our field. Moving forward, Prima looks to monetize our assets (such as our products and technology) through commercial partnerships or licenses and we plan for continued investment to remain a leader
in immunocellular therapeutics for cancer.
Clinical development
In October and November, 2012, Prima reported positive interim data from its ongoing CAN-003 clinical trial of CVac in ovarian cancer. There are encouraging trends of increased progression free survival
for patients receiving CVac versus the control group in that study. Based on the analysis of seven patients from CAN-003, CVac demonstrates an ability to induce a mucin 1 specific T cell response in patients.
During calendar year 2013, we expect two important data points from the CAN-003 trial. In the third quarter of calendar year 2013, we plan to release the
full immune monitoring profile of all 63 patients over multiple time points during the trial. In the fourth quarter of calendar year 2013, we will have the final protocol analysis of progression free survival and the first evaluation of overall
Prima also continued a controlled rollout of the CAN-004 (also called CANVAS ) clinical trial. As of 01 February
2013, the status of this trial is as follows:
Directors Report (continued)
We expect a significant increase in the number of patients on the CANVAS trial as Prima authorizes the commencement of the trial at additional hospitals throughout the upcoming year.
The CANVAS trial represents a significant investment from Prima and we are highly committed to assuring quality, safety, and data integrity throughout
the project. Our goals from the CANVAS trial include:
Based on current CVac data which demonstrate the immune activity of CVac, Prima believes that CVac may have beneficial applications for cancer targets in addition to ovarian cancer. We may consider the
initiation of pilot (phase 2) clinical trials of CVac for additional mucin 1 overexpressing cancer targets pending the appropriate resources to do so.
Manufacturing development
Through the 31st of December 2012, Prima has achieved some very important
manufacturing milestones that confirm our leadership position in our field and support our ongoing development of CVac, including:
Looking forward with our manufacturing development activities, Prima will be scaling up our platform to support hundreds of patients on the CANVAS trial,
to potentially support additional CVac trials, with the longer term goal of bringing a high quality and cost effective product to the market.
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 4. This report is
made in accordance with a resolution of directors.
| Mr Matthew Lehman |
| CEO and Executive Director |
| Dated: 22 nd Day of February 2013 |
Auditor s Independence Declaration
As lead auditor for the review of Prima BioMed
Ltd for the half-year ended 31 December 2011, I declare that, to the best of my knowledge and belief, there have been:
This declaration is in respect of Prima BioMed Ltd and the entities it controlled during the period.
| Manoj Santiago | ||
| Partner | Sydney | |
| PWC | Dated: 22 nd Day of February 2013 |
Consolidated Statement of Comprehensive Income
For the Half Year Ended 31 December 2012
| Note | 31 December 2012 | 31 December 2011 | ||||||||
| $ | $ | |||||||||
| OTHER INCOME | ||||||||||
| Medical services revenue | 13,139 | |||||||||
| Grant income | 1,488,767 | 1,477,576 | ||||||||
| Interest income | 590,453 | 1,540,764 | ||||||||
| Total other income | 2,079,220 | 3,031,479 | ||||||||
| EXPENSES | ||||||||||
| Depreciation and amortisation | (118,138 | ) | (78,922 | ) | ||||||
| Research and development and intellectual property | (7,279,338 | ) | (7,515,131 | ) | ||||||
| Corporate administrative expenses | (2,607,964 | ) | (3,281,424 | ) | ||||||
| Changes in fair value of derivative financial instruments | 7 | (37,190 | ) | (1,470,049 | ) | |||||
| Loss before income tax | (7,963,410 | ) | (9,314,047 | ) | ||||||
| Income tax expense | 9 | (66,996 | ) | |||||||
| Loss for the half-year | (8,030,406 | ) | (9,314,047 | ) | ||||||
| Other Comprehensive Income (Loss) | ||||||||||
| Exchange differences on the translation of foreign operations | 160,658 | (77,523 | ) | |||||||
| Other comprehensive income (loss) for the half-year, net of income tax | 160,658 | (77,523 | ) | |||||||
| Total comprehensive loss for the half-year | (7,869,748 | ) | (9,391,570 | ) | ||||||
| Loss is attributable to: | ||||||||||
| Owners of Prima BioMed Ltd | (8,030,406 | ) | (9,314,047 | ) | ||||||
| Total comprehensive loss is attributable to: | ||||||||||
| Owners of Prima BioMed Ltd | (7,869,748 | ) | (9,391,570 | ) | ||||||
| Loss per share for loss attributable to the ordinary equity holders of the company: | ||||||||||
| Basic and diluted loss per share (cents) | (0.75 | ) | (0.92 | ) |
The above consolidated statement of comprehensive income should be read in conjunction with the accompanying notes.
Consolidated Balance Sheet
As at 31 December 2012
| Note | 31 December 2012 | 30 June 2012 | ||||||||
| $ | $ | |||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 11,024,073 | 16,991,716 | ||||||||
| Current receivables | 4 | 1,602,110 | 280,384 | |||||||
| Held-to-maturity investments | 5 | 17,045,423 | 21,045,423 | |||||||
| Inventories | 191,727 | |||||||||
| Other current assets | 8 | 2,019,431 | 2,393,734 | |||||||
| Total current assets | 31,691,037 | 40,902,984 | ||||||||
| Non-current assets | ||||||||||
| Plant and equipment | 6 | 453,475 | 483,928 | |||||||
| Intangible assets | 198,539 | 225,759 | ||||||||
| Total non-current assets | 652,014 | 709,687 | ||||||||
| Total assets | 32,343,051 | 41,612,671 | ||||||||
| LIABILITIES | ||||||||||
| Current liabilities | ||||||||||
| Trade and other payables | 2,139,957 | 2,840,583 | ||||||||
| Current tax payable | 9 | 66,996 | ||||||||
| Derivative financial instrument | 7 | 751,529 | 1,488,744 | |||||||
| Employee benefits | 20,692 | 115,145 | ||||||||
| Total current liabilities | 2,979,174 | 4,444,472 | ||||||||
| Non-current liabilities | ||||||||||
| Employee benefits | 3,122 | 10,328 | ||||||||
| Total non-current liabilities | 3,122 | 10,328 | ||||||||
| Total liabilities | 2,982,296 | 4,454,800 | ||||||||
| Net Assets | 29,360,755 | 37,157,871 | ||||||||
| EQUITY | ||||||||||
| Issued capital | 10 | 136,712,525 | 136,712,525 | |||||||
| Reserves | 414,310 | 181,020 | ||||||||
| Accumulated losses | (107,766,080 | ) | (99,735,674 | ) | ||||||
| Equity attributable to the owners of Prima BioMed Ltd | 29,360,755 | 37,157,871 | ||||||||
| Total Equity | 29,360,755 | 37,157,871 |
The above consolidated balance sheet should be read in conjunction with the accompanying notes.
Consolidated Statement of Changes in Equity
For the Half Year Ended 31 December 2012
| Issued Capital | Reserves | Accumulated Losses | Total | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Balance at 1 July 2011 | 134,895,001 | (1,157 | ) | (79,794,714 | ) | 55,099,130 | ||||||||||
| Loss for the half-year | (9,314,047 | ) | (9,314,047 | ) | ||||||||||||
| Other comprehensive loss | (77,523 | ) | (77,523 | ) | ||||||||||||
| Total comprehensive income for the half-year | (77,523 | ) | (9,314,047 | ) | (9,391,570 | ) | ||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||
| Contribution of equity, net of transaction cost | 1,369,921 | 1,369,921 | ||||||||||||||
| Employee options scheme | 262,147 | 262,147 | ||||||||||||||
| Balance at 31 December 2011 | 136,264,922 | 183,467 | (89,108,761 | ) | 47,339,628 | |||||||||||
| Loss for the half-year | (10,626,913 | ) | (10,626,913 | ) | ||||||||||||
| Other comprehensive income for the year, net of tax | (39,712 | ) | (39,712 | ) | ||||||||||||
| Total comprehensive income for the half-year | (39,712 | ) | (10,626,913 | ) | (10,666,625 | ) | ||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||
| Contribution of equity, net of transaction cost | 447,603 | 447,603 | ||||||||||||||
| Employee options scheme | 37,265 | 37,265 | ||||||||||||||
| Balance at 30 June 2012 | 136,712,525 | 181,020 | (99,735,674 | ) | 37,157,871 | |||||||||||
| Loss for the half-year | (8,030,406 | ) | (8,030,406 | ) | ||||||||||||
| Other comprehensive loss | 160,658 | 160,658 | ||||||||||||||
| Total comprehensive income for the half-year | 160,658 | (8,030,406 | ) | (7,869,748 | ) | |||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||
| Employee options scheme | 72,632 | 72,632 | ||||||||||||||
| Balance at 31 December 2012 | 136,712,525 | 414,310 | (107,766,080 | ) | 29,360,755 |
The above consolidated statement of changes in equity should be read in conjunction with the accompanying notes.
Consolidated Statement of Cash Flows
For the Half Year Ended 31 December 2012
| 31 December 2012 | 31 December 2011 | |||||||
| $ | $ | |||||||
| CASH FLOWS RELATED TO OPERATING ACTIVITIES | ||||||||
| Payments to suppliers and employees (inclusive of Goods and Service Tax) | (10,646,482 | ) | (10,778,837 | ) | ||||
| Interest received | 683,318 | 774,092 | ||||||
| Grant received | 46,647 | 747,754 | ||||||
| NET CASH FLOWS (USED) IN OPERATING ACTIVITIES | (9,916,517 | ) | (9,256,991 | ) | ||||
| CASH FLOWS RELATED TO INVESTING ACTIVITIES | ||||||||
| Payment for purchases of plant and equipment | (51,126 | ) | (564,094 | ) | ||||
| Funds invested in term deposits | (17,045,423 | ) | (36,957,404 | ) | ||||
| Funds from maturity of investment on term deposits | 21,045,423 | 10,000,000 | ||||||
| NET CASH FLOWS PROVIDED (USED) IN INVESTING ACTIVITIES | 3,948,874 | (27,521,498 | ) | |||||
| CASH FLOWS RELATED TO FINANCING ACTIVITIES | ||||||||
| Proceeds from issues of securities | 1,367,990 | |||||||
| Share issue transaction costs | (2,069 | ) | ||||||
| NET CASH FLOWS PROVIDED BY FINANCING ACTIVITIES | 1,365,921 | |||||||
| NET (DECREASE) IN CASH AND CASH EQUIVALENTS | (5,967,643 | ) | (35,412,568 | ) | ||||
| Cash and cash equivalents at the beginning of the half year | 16,991,716 | 45,918,552 | ||||||
| CASH AND CASH EQUIVALENTS AT THE END OF THE HALF YEAR | 11,024,073 | 10,505,984 |
The above consolidated statement of cash flows should be read in conjunction with the accompanying notes.
Notes to the Financial Statements
1. Summary of Significant Accounting Policies
a) Basis of Preparation
consolidated financial statements are a general purpose financial report prepared in accordance with the requirements of the Corporations Act 2001, Australian Accounting Standard AASB 134: Interim Financial Reporting, Australian Accounting
Interpretations and other authoritative pronouncements of the Australian Accounting Standards Board.
The half-year report does not include
full disclosures of the type normally included in an annual report and therefore cannot be expected to provide as full an understanding of the financial performance, financial position and financing and investing activities of the consolidated
entity as the annual report.
It is recommended that this financial report be read in conjunction with the annual financial report for the
year ended 30 June 2012 and any public announcements made by Prima BioMed Ltd and its controlled entities during the half-year in accordance with continuous disclosure requirements arising under the Corporations Act 2001.
International Financial Reporting Standards form the basis of Australian Accounting Standards adopted by the AASB. The half-year financial report
complies with International Accounting Standards ( IAS ) 34 Interim Financial Reporting as issued by the International Accounting Standards Board ( IASB ).
The accounting policies adopted are consistent with those of the previous financial year and corresponding half-year reporting period.
b) New accounting standards and interpretations
AASB 9 (IFRS 9) Financial
Instruments, AASB 2009-11 Amendments to Australian Accounting Standards arising from AASB 9 and AASB 2010-7 Amendments to Australian Accounting Standards arising from AASB 9 (December 2010)
(effective for annual reporting periods beginning on or after 1 January 2015)
AASB 9 Financial Instruments addresses the
classification, measurement and derecognition of financial assets and financial liabilities. The standard is not applicable until 1 January 2015 but is available for early adoption. When adopted, the standard will affect in particular the
group s accounting for available-for-sale financial assets, since AASB 9 only permits the recognition of fair value gains and losses in other comprehensive income if they relate to equity investments that are not held for trading. Fair value
gains and losses on available-for-sale debt investments, for example, will therefore have to be recognised directly in profit or loss. The group is yet to assess the full impact and intends to adopt it no later than the accounting period beginning