Full Press Release Details
For the Half-Year Ended
corresponding period: half-year ended 31 December 2012)
To be read in conjunction with the 30 June 2013 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 2013
Previous Reporting Period Half-year Ended 31 December 2012
| Revenues | Unchanged | to | ||||
| Loss after tax attributable to members | Down | 25.83% to ($5,956,531) | ||||
| Net loss for the period attributable to members | Down | 25.83% to ($5,956,531) |
| 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 2013 | 2.43 | |
| As at 31 December 2012 | 2.74 |
Explanation of the above information:
Refer to the Directors Report Review of Operations.
| Directors Report | 2 | |||
| Auditor s Independence Declaration | 5 | |||
| Consolidated Statement of Comprehensive Income | 6 | |||
| Consolidated Balance Sheet | 7 | |||
| Consolidated Statement of Changes in Equity | 8 | |||
| Consolidated Statement of Cash Flows | 9 | |||
| Notes to the Financial Statements | 10 | |||
| Directors Declaration | 18 | |||
| Independent Auditor s Review Report to the Members | 19 |
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 2013.
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 Director and Chairman)
Mr Matthew Lehman (CEO and Executive Director)
Mr Albert Wong (Non-executive Deputy Chairman and Chair of Audit Committee)
Dr Richard Hammel (Non-executive Director until 12 February 2014)
Dr Russell J. Howard (Non-executive Director)
Mr Martin Rogers (Non-executive Director until 15 November 2013)
Mr Pete A. Meyers (Non-executive Director appointed on 12 February 2014)
Review of Operations
CVac, Prima s lead product candidate, is a personalized immunocellular therapy in clinical trials for the treatment of epithelial ovarian cancer.
Based on top-line Progression-Free Survival (PFS) results from our 63-patient CAN-003 trial presented in September 2013, the Company has made significant
updates to the clinical development strategy for CVac.
The directors are encouraged by the CAN-003 data released to date. CVac demonstrated a clinically
significant improvement in median PFS as compared to standard of care for epithelial ovarian cancer patients in remission after second-line treatment. The magnitude of the increase in PFS, as well as the extended duration of the PFS intervals, in
the second line patient group are very compelling signals. During the first half of calendar year 2014, Prima expects that all final CAN-003 PFS and immune monitoring data will have been analysed and we look forward to presentation and/or
publication in a scientific forum. We also expect to release updated Overall Survival (OS) data from the CAN-003 trial in the fourth quarter of calendar year 2014.
Based on the compelling signals from CAN-003, Prima is now moving forward with a 210-patient randomized phase 2 trial of CVac versus standard of care in
epithelial ovarian cancer patients who are in remission after second line therapy. This is to be conducted as an amendment to the ongoing CAN-004 trial1. As of the date of this report, recruitment
into the 210-patient cohort will begin on schedule.
CVac has received orphan designation for ovarian cancer in both the U.S. and Europe. On approval,
CVac would receive seven years (in the US) and ten years (in Europe) market exclusivity, as well as other benefits such as reduced regulatory fees. If Prima is able to confirm an OS benefit in second remission ovarian cancer patients in CAN-004, we
believe that FDA breakthrough and/or fast track designation is a possible regulatory pathway given the limited number of approved drugs to treat ovarian cancer.
We also expect to release data from the CAN-003X trial in the second calendar quarter of 2014. This extension protocol included 9 patients who had enrolled on
the CAN-003 and chose to continue CVac treatment after completing the CAN-003 protocol.
Directors Report (continued)
Prima will also soon be starting a pilot trial of CVac for the treatment of pancreatic cancer; the CAN-301
protocol is a 40-patient pilot, multicenter, single-arm trial of CVac for the maintenance treatment of resected pancreatic cancer patients. This trial will assess OS, PFS, adverse events, and immune and biomarker monitoring. Prima believes that CVac
would have potential applications in additional cancer types that over express mucin 1. If CAN-301 shows promise in pancreatic cancer, this will broaden the potential clinical applications for CVac and enhance the potential commercial value of the
Looking forward, there are a number of operational milestones and data catalysts expected from the CVac clinical development programs as
summarized in the following table.*
Manufacturing Operations
prepare for CAN-004, Prima has accomplished a number of unique and valuable milestones in its ability to transfer manufacturing technology, to reliably produce a comparable product in 3 different facilities, to automate global logistics, standardize
its cell collection processes, and meet manufacturing regulatory standards in a large number of potential markets including the US, Europe, and Asia-pacific. For personalized cell-based products such as CVac, the scalability and cost of
manufacturing are critical components of a commercially successful product.
In conjunction with our revised CVac development strategy, we have
consolidated most of our manufacturing operations in Leipzig, Germany. Prima currently employs 17 manufacturing related professionals in Leipzig who, along with our colleagues at the Fraunhofer Institute of Cell Therapy and Immunology, are
continuously optimizing our manufacturing processes. The Fraunhofer and Prima teams in Leipzig will be providing CVac for our ongoing clinical trials. Longer term, Prima s manufacturing group in Germany will lead preparations for future phase 3
trials and cost-effective commercial scale up.
Corporate Development
Prima announced that it entered into a binding term sheet for the license of CVac rights to Neopharm Group in Israel and Palestine. The final agreement is
expected to be executed in the first calendar quarter of 2014. This is the first commercial partnership for CVac.
Directors Report (continued)
In the first half of financial year 2014 we remained in a good financial position with over A$28,580,431 in cash and term deposits. We raised A$6,845,000 in
the share purchase plan shortfall placement in July and August 2013. We have benefited from substantial foreign exchange gains due to our significant Euro and USD cash holdings. Our foreign exchange gain for the first half of financial year 2014 was
approximately A$719,424 which compares favourably to the same period last year where we reported a loss on foreign exchange of A$236,884. We also benefited from cash grants from the Australian R&D tax incentive program and two separate grants
from the Saxony Development Bank in Germany. Overall the total other income was A$782,499 higher than in the corresponding period last year and reached A$2,861,719.
Our most significant expenses are our R&D expenses arising from contracts with Contract Research Organisations (CROs), Contract Manufacturing
Organisations (CMOs) and clinical investigators. Due to our revised clinical program and consolidation of manufacturing into Germany we have lowered our R&D expenses by A$1,158,901 compared to the same period last year. Total R&D and
intellectual property expenses in first half of financial year 2014 was A$6,120,437. Our total corporate and administrative expenses in the first half of financial year 2014 was A$2,210,386, which was also less compared to the corresponding period.
The reduction in our expenses reflect our ongoing commitment to actively manage our costs.
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 5. This report is made in
accordance with a resolution of directors.
| Mr Matthew Lehman |
| CEO and Executive Director |
| Dated: 18 th Day of February 2014 |
Auditor s Independence Declaration
As lead auditor for the review of Prima BioMed Ltd for the half-year ended 31 December 2013, I declare that to the best of my knowledge and belief, there
is in respect of Prima BioMed Ltd. And the entities it controlled during the period.
| Rod Dring | Sydney | |||
| Partner | 18 February 2014 | |||
| PricewaterhouseCoopers |
PricewaterhouseCoopers, ABN 52 780 433 757
Darling Park Tower 2, 201 Sussex Street, GPO BOX 2650, SYDNEY NSW 1171
T: +61 2 8266 0000, F: +61 2 8266 9999, www.pwc.com.au
Liability limited by a scheme approved under Professional Standards Legislation.
Consolidated Statement of Comprehensive Income
For the Half Year Ended 31 December 2013
| Note | 31 December 2013 | 31 December 2012 | ||||||||||
| $ | $ | |||||||||||
| OTHER INCOME | ||||||||||||
| Grant income | 1,743,803 | 1,488,767 | ||||||||||
| Gain on foreign exchange | 719,424 | |||||||||||
| Interest income | 398,492 | 590,453 | ||||||||||
| Total other income | 2,861,719 | 2,079,220 | ||||||||||
| EXPENSES | ||||||||||||
| Depreciation and amortisation | (219,362 | ) | (118,138 | ) | ||||||||
| Research and development and intellectual property | (6,120,437 | ) | (7,279,338 | ) | ||||||||
| Corporate administrative expenses | (2,210,386 | ) | (2,371,080 | ) | ||||||||
| Loss on foreign exchange | (236,884 | ) | ||||||||||
| Changes in fair value of derivative financial instruments | 7 | (232,290 | ) | (37,190 | ) | |||||||
| Loss before income tax | (5,920,756 | ) | (7,963,410 | ) | ||||||||
| Income tax expense | 9 | (35,775 | ) | (66,996 | ) | |||||||
| Loss for the half-year | (5,956,531 | ) | (8,030,406 | ) | ||||||||
| Other Comprehensive Income | ||||||||||||
| Exchange differences on the translation of foreign operations | 168,491 | 160,658 | ||||||||||
| Other comprehensive income for the half-year, net of income tax | 168,491 | 160,658 | ||||||||||
| Total comprehensive loss for the half-year | (5,788,040 | ) | (7,869,748 | ) | ||||||||
| Loss is attributable to: | ||||||||||||
| Owners of Prima BioMed Ltd | (5,956,531 | ) | (8,030,406 | ) | ||||||||
| Total comprehensive loss is attributable to: | ||||||||||||
| Owners of Prima BioMed Ltd | (5,788,040 | ) | (7,869,748 | ) | ||||||||
| Loss per share for loss attributable to the ordinary equity holders of the company: | ||||||||||||
| Basic and diluted loss per share (cents) | (0.49 | ) | (0.75 | ) |
The above consolidated statement of comprehensive income should be read in conjunction with the accompanying notes.
Consolidated Balance Sheet
As at 31 December 2013
| Note | 31 December 2013 | 30 June 2013 | ||||||||||
| $ | $ | |||||||||||
| ASSETS | ||||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 17,267,401 | 22,023,143 | ||||||||||
| Current receivables | 4 | 1,756,193 | 200,477 | |||||||||
| Held-to-maturity investments | 5 | 11,313,030 | 8,000,000 | |||||||||
| Other assets | 8 | 1,080,231 | 1,584,679 | |||||||||
| Total current assets | 31,416,855 | 31,808,299 | ||||||||||
| Non-current assets | ||||||||||||
| Plant and equipment | 6 | 760,873 | 834,678 | |||||||||
| Intangible assets | 144,101 | 171,321 | ||||||||||
| Other assets | 8 | 490,000 | ||||||||||
| Total non-current assets | 1,394,974 | 1,005,999 | ||||||||||
| Total assets | 32,811,829 | 32,814,298 | ||||||||||
| LIABILITIES | ||||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 2,351,223 | 3,468,553 | ||||||||||
| Current tax payable | 9 | 40,798 | 27,065 | |||||||||
| Derivative financial instrument | 7 | 275,273 | 33,714 | |||||||||
| Employee benefits | 129,206 | 30,800 | ||||||||||
| Total current liabilities | 2,796,500 | 3,560,132 | ||||||||||
| Non-current liabilities | ||||||||||||
| Employee benefits | 9,972 | 5,748 | ||||||||||
| Total non-current liabilities | 9,972 | 5,748 | ||||||||||
| Total liabilities | 2,806,472 | 3,565,880 | ||||||||||
| Net assets | 30,005,357 | 29,248,418 | ||||||||||
| EQUITY | ||||||||||||
| Issued capital | 10 | 148,837,200 | 142,326,977 | |||||||||
| Reserves | 2,086,033 | 1,882,786 | ||||||||||
| Accumulated losses | (120,917,876 | ) | (114,961,345 | ) | ||||||||
| Equity attributable to the owners of Prima BioMed Ltd | 30,005,357 | 29,248,418 | ||||||||||
| Total equity | 30,005,357 | 29,248,418 |
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 2013
| Issued | Accumulated | |||||||||||||||
| Capital | Reserves | Losses | Total | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Balance at 1 July 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 income | 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 | |||||||||||
| Balance at 1 July 2013 | 142,326,977 | 1,882,786 | (114,961,345 | ) | 29,248,418 | |||||||||||
| Loss for the half-year | (5,956,531 | ) | (5,956,531 | ) | ||||||||||||
| Other comprehensive loss | 168,491 | 168,491 | ||||||||||||||
| Total comprehensive income for the half-year | 168,491 | (5,956,531 | ) | (5,788,040 | ) | |||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||
| Contribution of equity, net of transaction cost | 6,510,223 | 6,510,223 | ||||||||||||||
| Employee options scheme | 34,756 | 34,756 | ||||||||||||||
| Balance at 31 December 2013 | 148,837,200 | 2,086,033 | (120,917,876 | ) | 30,005,357 |
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 2013
| 31 December 2013 | 31 December 2012 | |||||||
| $ | $ | |||||||
| CASH FLOWS RELATED TO OPERATING ACTIVITIES | ||||||||
| Payments to suppliers and employees (inclusive of Goods and Service Tax) | (8,818,227 | ) | (10,866,427 | ) | ||||
| Interest received | 393,889 | 683,318 | ||||||
| Tax paid | (22,042 | ) | ||||||
| Grant received | 145,084 | 46,647 | ||||||
| NET CASH FLOWS (USED) IN OPERATING ACTIVITIES | (8,301,296 | ) | (10,136,462 | ) | ||||
| CASH FLOWS RELATED TO INVESTING ACTIVITIES | ||||||||
| Payment for purchases of plant and equipment | (52,505 | ) | (51,126 | ) | ||||
| Funds invested in term deposits | (11,313,030 | ) | (17,045,423 | ) | ||||
| Funds from maturity of term deposits | 8,000,000 | 21,045,423 | ||||||
| NET CASH FLOWS (USED) PROVIDED IN INVESTING ACTIVITIES | (3,365,535 | ) | 3,948,874 | |||||
| CASH FLOWS RELATED TO FINANCING ACTIVITIES | ||||||||
| Proceeds from issues of securities | 6,845,000 | |||||||
| Share issue transaction costs | (334,777 | ) | ||||||
| NET CASH FLOWS PROVIDED BY FINANCING ACTIVITIES | 6,510,223 | |||||||
| NET (DECREASE) IN CASH AND CASH EQUIVALENTS | (5,156,608 | ) | (6,187,588 | ) | ||||
| Effect on exchange rate on cash and cash equivalent | 400,866 | 219,945 | ||||||
| Cash and cash equivalents at the beginning of the half year | 22,023,143 | 16,991,716 | ||||||
| CASH AND CASH EQUIVALENTS AT THE END OF THE HALF YEAR | 17,267,401 | 11,024,073 |
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
The half-year 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