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Company Announcements
Announcement of Results Year ended 30 June 2012
Please find attached the
Appendix 4E and annual financial report for the year ended 30 June 2012.
In the interest of saving trees please send all invoices to accounts@primabiomed.com.au
Preliminary final report
PRELIMINARY FINAL REPORT
| Name of entity: | Prima BioMed Ltd | |||
| ABN: | 90 009 237 889 | |||
| Reporting period: | Year ended 30 June 2012 | |||
| Previous corresponding period: | Year ended 30 June 2011 |
2. Results for announcement to the market
| Revenue from ordinary activities | up | 294% | to | $ | 3,136,371 | |||||
| Loss from ordinary activities after tax attributable to the owners of Prima BioMed Ltd | down | 5.41% | to | $ | (19,940,960 | ) | ||||
| Loss for the period attributable to the owners of Prima BioMed Ltd | down | 5.41% | to | $ | (19,940,960 | ) | ||||
| Dividends There were no dividends paid or declared during the current financial period Comments The loss of the consolidated entity after providing for income tax and non-controlling interest amounted to $19,940,960 (30 June 2011: $21,081,167) |
| Net tangible asset backing per ordinary security | Reporting period | Previous corresponding period | ||
| 3.46 cents | 5.57 cents |
There were no dividends paid or declared during the current financial
Previous corresponding period
There were no dividends paid or declared during the previous financial period.
Preliminary final report
The financial statements have been audited and an unqualified opinion issued.
Details of attachments (if any):
The annual report for the year ended 30 June 2012 is attached.
| Corporate Directory | 03 | |||
| Chairman s Letter | 04 | |||
| Report from Chief Executive Officer | 05 | |||
| Review of Operations from COO and CEO Designate | 06 | |||
| Directors Report | 10 | |||
| Management directory | 15 | |||
| Corporate Governance Report | 25 | |||
| Auditors Independence Declaration | 31 | |||
| Statement of Comprehensive Income | 33 | |||
| Statement of Financial Position | 34 | |||
| Statement of Changes in Equity | 35 | |||
| Statement of Cash Flows | 36 | |||
| Notes to the Financial Statements | 37 | |||
| Directors Declaration | 78 | |||
| Independent Auditor s Report to the Members | 79 | |||
| Shareholder Information. | 81 |
| Directors | Ms Lucy Turnbull, AO (Non Executive Chairman) Mr Albert Wong (Non Executive Deputy Chairman) Mr Martin Rogers (Managing Director & Chief Executive Officer) Mr Matthew Lehman (Chief Operating Officer & Chief Executive Officer designate) Dr Richard Hammel (Non Executive Director) | . | ||
| Company secretary | Mr Ian Bangs | |||
| Registered office & principal place of business | Level 7 151 Macquarie Street Sydney NSW 2000 | |||
| Share register | Boardroom Pty Ltd Level 7, 207 Kent Street Sydney, NSW 2000 | |||
| Auditor | PricewaterhouseCoopers 201 Sussex Street Sydney, NSW 1171 | |||
| Solicitors | McCabes Level 14, 130 Elizabeth Street Sydney, NSW 2000 | |||
| Cooley LLP 101 California 5 th Floor San Francisco, CA, USA | ||||
| Banker | National Australia Bank Ltd Kew Branch Melbourne, Victoria 3000 | |||
| Stock exchange listing | Prima BioMed Ltd shares are listed on the: Australian Securities Exchange (ASX code: PRR), NASDAQ (NASDAQ code: PBMD), and Deutsche B rse | |||
| Website address | www.primabiomed.com.au |
I am pleased to report on what has been another year of good progress for Prima
BioMed and the continued development of our core program, CVac , the autologous dendritic cell product currently in clinical trials for ovarian cancer. Ovarian cancer is one of the most challenging types of cancer to diagnose and to treat, and
we believe that CVac has the potential to make a real difference to the lives of women and their loved ones who are affected by this terrible disease.
During the last financial year, the Company continued to advance clinical trials of CVac. Enrolment for the 63 patient CAN-003 trial was completed in September 2011, and we now look forward to releasing
interim trial data at the International Gynecologic Cancer Society (IGCS) meeting in October 2012. Also, patient enrolment into the pivotal CANVAS trial commenced, and the Company will provide periodic updates on recruitment in to this study in the
Significantly, in the past 12 months, the Company has established a global manufacturing and logistics platform to support its
clinical trials. It was awarded manufacturing licenses to produce CVac in Germany and Australia, and CVac is also being manufactured in the U.S. These are important milestones, and provide for CVac to be available for patients in our clinical trials
in sites across the globe. We believe that this global platform for the manufacturing and logistics for cellular based therapies is a real comparative advantage and strength for the Company. As far as we are aware, we are among the world leaders in
The Company listed American Depository Receipts on the NASDAQ market and the Deutsche B rse (German Stock Exchange) in April
and June this year. This step is consistent with Prima s operational growth and increases the visibility of Prima globally.
the year, the Company implemented a number of changes to its Board and senior management team. These changes were designed to facilitate CVac s continued clinical and regulatory development and best position the Company for its next phase of
Matthew Lehman, who was the Company s Chief Operating Officer for a period of two and a half years, is our new CEO. Matt has
extensive experience in product development and research and the execution of clinical trials, which will be pivotal to the Company moving forward. I would also like to acknowledge the hard work of our previous CEO, Martin Rogers. Martin worked
energetically to grow the Company and will continue to serve shareholders as a non-executive director. He assembled a world-class management team, and leaves the Company in a sound financial position, with significant opportunity for growth.
I would like to finish by taking the opportunity to thank all shareholders for their ongoing support, in what has been a difficult period in
investment markets. The Company values this loyal support, and on behalf of the Board and all the Prima team, I look forward to sharing news on the progress of your Company in the year ahead.
REPORT FROM CHIEF EXECUTIVE OFFICER
I am pleased to report that, over the past year, Prima has transformed into a world class company and a leader in the development of personalized bio-therapeutics. We have accelerated our momentum in the
development of CVac, having completed recruitment for our 63-patient CAN-003 study and commenced recruitment into the 800-patient CANVA trial. And we remain in a solid financial position with more than $38 million in available funds (in cash and
The funds invested by our shareholders have been deployed judiciously to build a strong foundation from which to support
CVac s development and grow the Company in the future. While our share price has slumped in the past year, we have added significant tangible value to the company in terms of advancing CVac through development and consolidating our technology
platform. I am confident that we will see the sustainable benefits of our investment as we move forward.
I am especially excited by the
appointment of Matthew Lehman as the Company s next Chief Executive Officer and the promotions of key senior managers Dr. Sharron Gargosky and Mr. Marc Voigt. Along with Dr. Neil Frazer and Mr. Ian Bangs, the executive team
has the right skills and experience to fully exploit Prima s technology and business opportunities.
In parting, I would like to thank
all of the patients, doctors, scientists, the board, the Prima team, and our investors for the enormous support of CVac and the Company in the past year. I look forward to continuing in my role as a no-executive director to support the very bright
future that lies ahead.
Managing Director & Chief Executive Officer (CEO)
REVIEW OF OPERATIONS FROM COO AND CEO DESIGNATE
On behalf of the directors and management team of Prima BioMed, I am delighted to report on our progress. The past year has been one of operational
consolidation and team building. We have built a strong foundation to support our CVac development program for ovarian cancer. Our global platform to produce personalized bio-therapeutics such as CVac is a major accomplishment and a unique asset to
We are in a position of financial strength. Prima ends the year with more than $38 million (in cash and term deposits) to continue
development of CVac and further capitalize on our technological advantages in personalized bio-therapeutics. We have no debt and the Company stands to benefit from non-dilutive cash resources from the Australian R&D tax incentive program and the
German State of Saxony s Development Bank grant to support CANVAS in Europe.
To date, we have successfully completed two human clinical
trials of CVac (CAN-001 and CAN-002), we achieved full recruitment of 63 patients in the CAN-003 trial, and commenced recruitment for our major 800-patient CAN-004 ( CANVAS ) trial for ovarian cancer patients in remission. Our growing body
of data continues to demonstrate the safety of CVac administration and we look forward to further biological and clinical efficacy data from our ongoing trials that would support future regulatory approvals in major commercial markets worldwide.
Major accomplishments for the past business year:
Strengthening the Management Team
In May 2012, the Prima restructured its senior
management and board of directors after a carefully considered process which involved the entire board. The changes are designed to best position Prima for its next stage of growth and facilitate a strong focus on product and technology development.
Martin Rogers will step down as Chief Executive Officer, effective 31 August 2012, and be replaced by the Company s Chief Operating
Officer Matthew Lehman. Mr. Rogers will remain on the Company s board as a non-executive director. Mr. Lehman joined the board as an executive director, replacing the Company s Chief Medical Officer Dr. Neil Frazer (in line
with Corporate Governance Principles and ASX recommendations that non-executive directors maintain a majority on the Company s board). Dr. Frazer continues in his senior management role as Chief Medical Officer.
Dr. Sharron Gargosky was promoted to Chief Technical Officer. In this role she is responsible for leading the scientific and technical development
of CVac globally. Marc Voigt was promoted to the position of Chief Business Officer and General Manager of Prima s German subsidiary. He is in charge of investor relations and driving Prima s business development.
Prima is focused on the
development of CVac and the technology platform underpinning CVac. In the past year, the Company has made significant progress in establishing its global manufacturing, distribution, technology, and research platform to support CVac development. We
are among the world leaders in terms of the global breadth of our capacity and we are determined to bring our technology platform to its full potential both to support CVac and the potential to develop other personalized bio-therapeutic
The promotions of Dr. Gargosky and Mr. Voigt are intended to support our strategy with a focus on further technology
development and business development activities.
During the past year, Prima ended its pilot commercial program in Dubai and stopped
pre-clinical development of a Cripto-1 antibody. This allows the Company to fully direct its resources toward development of CVac and its technology platform.
REVIEW OF OPERATIONS FROM COO AND CEO DESIGNATE
Prima has continued funding early stage research into the use of super critical fluid technology for its application to reformulate oral vaccines such as
the HPV vaccine. The research is led by Dr. Neil Foster and the University of New South Wales and testing of formulations has been performed at Dr. Ian Frazer s laboratory at the University of Queensland.
Grant from the Saxony Development Bank
In August 2011, the Saxony Development Bank of the German State of Saxony, or SAB, awarded a grant of EUR 4.1 million to support clinical trials of
CVac in Europe. Part of this grant is paid directly to Prima BioMed GmbH as reimbursement for eligible development costs. The majority of the grant (3.5 million Euro) is paid to the Fraunhofer-Gesellschaft zur F rderung der angewandten
Forschung e.V., or Fraunhofer Institute, as reimbursement for Cvac manufacturing costs to support clinical trials in Europe. The amounts paid to the Fraunhofer Institute reduce the costs incurred by Prima BioMed for manufacturing CVac in Europe for
clinical trials. In the event SAB does not reimburse the Fraunhofer Institute for their eligible manufacturing costs, Prima BioMed GmbH is obligated to pay the Fraunhofer for contract manufacturing costs.
CVac product development
pleased to report major advances in CVac product development over the past year. The manufacturing quality of our product is of the highest importance to regulators globally and is a key component to assuring patient safety and consistent product
efficacy in the future.
Prima has hired key personnel to manage our overall manufacturing needs and our supply chain. Marta Schilling was
appointed as our Vice President of Manufacturing to oversee our global needs in this respect. We have also hired and trained a number of technical staff to support CVac manufacturing and product development. Prima successfully transferred the CVac
technology to our third global facility at the Fraunhofer Institute of Cell Therapy and Immunology in Leipzig, Germany and this facility obtained the required manufacturing authorization to produce CVac for clinical trials.
In the last year, Prima has qualified and secured a supply chain for the starting materials and equipment necessary of making CVac. Our Leipzig facility
has been prepared as our global storage and logistics center to handle our materials under GMP conditions. Of note, we have scaled up manufacturing of the CVac antigen (Mannosylated Fusion Protein or M-FP) at our contract manufacturer Pharmasynth
Pty Ltd in Brisbane, Australia. The M-FP is a critical component to CVac as it is contains the antigen necessary for the dendritic cells to illicit an immune response against tumor cells.
Besides M-FP, the other critical component to CVac is the autologous mononuclear cells collected from each patient. These cells are collected by blood centers around the globe that have been qualified and
trained by Prima on our exact specifications. The contracts with these centers and the cells they collect represent an integral part of consistently manufacturing a quality product.
Personalized bio-therapeutics such as CVac can present certain challenges in terms of consistency of manufacturing quality, logistics coordination, and production costs; however, Prima has developed
important tools to meet these challenges.
On the quality side, we have implemented a battery of in-process and finished product quality