Full Press Release Details
Preliminary final report
PRELIMINARY FINAL REPORT
| Name of entity: | Prima BioMed Ltd | |
| ABN: | 90 009 237 889 | |
| Reporting period: | Year ended 30 June 2015 | |
| Previous corresponding period: | Year ended 30 June 2014 |
| Revenue from ordinary activities | Down | 33.3% | to | $2,092,867 | ||||
| Loss from ordinary activities after tax attributable to the owners of Prima BioMed Ltd | Up | 141% | to | $(32,151,696) | ||||
| Loss for the period attributable to the owners of Prima BioMed Ltd | Up | 141% | to | $(32,151,696) | ||||
| 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 $32,151,696 (30 June 2014: $13,343,381) |
| Net tangible asset backing per ordinary security | Reporting period | Previous corresponding period | ||||||
| 0.12 cents | 1.83 cents |
There were no dividends paid or declared during the current financial period
Previous corresponding period
There were no dividends paid or declared during the previous financial period.
Preliminary final report
report is based on financial statements which have been audited.
Details of attachments (if any):
The annual report for the year ended 30 June 2015 is attached.
| Date: Friday, 28 th August 2015 | ||||||
| Company Secretary |
| Corporate Directory | 3 | |||
| Chairman s Letter | 4 | |||
| Review of Operations | 6 | |||
| Directors Report | 11 | |||
| Management Directory | 16 | |||
| Corporate Governance Report | 30 | |||
| Auditor s Independence Declaration | 36 | |||
| Consolidated Statement of Comprehensive Income | 38 | |||
| Consolidated Balance Sheet | 39 | |||
| Consolidated Statement of Changes in Equity | 40 | |||
| Consolidated Statement of Cash Flows | 41 | |||
| Notes to the Consolidated Financial Statements | 42 | |||
| Directors Declaration | 86 | |||
| Independent Auditor s Report to the Members | 87 | |||
| Shareholder Information | 89 |
| Directors | Ms Lucy Turnbull, AO (Non Executive Chairman) | |
| Mr Marc Voigt (Executive Director & Chief Executive Officer from 9 July 2014) | ||
| Mr Albert Wong (Non Executive Deputy Chairman) | ||
| Dr Russell Howard (Non Executive Director) | ||
| Mr Pete Meyers (Non Executive Director) | ||
| Mr Matthew Lehman (Executive Director & Chief Executive Officer until 9 July 2014) | ||
| Company Secretary | Ms Deanne Miller | |
| Registered office & | Level 7 | |
| principal place of business | 151 Macquarie Street | |
| Sydney NSW 2000 | ||
| Share Registry | Boardroom Pty Ltd | |
| Level 7, 207 Kent Street | ||
| Sydney, NSW 2000 | ||
| Auditor | PricewaterhouseCoopers | |
| 201 Sussex Street | ||
| Sydney, NSW 2000 | ||
| Solicitors | K&L Gates | |
| Level 31, 1 O Connell Street | ||
| Sydney NSW 2000 | ||
| Australia | ||
| Banker | National Australia Bank Ltd | |
| Kew Branch | ||
| Melbourne, Victoria 3000 | ||
| Stock exchange listings | Prima BioMed Ltd shares are listed on the: | |
| Australian Securities Exchange (ASX code: PRR), and | ||
| NASDAQ (NASDAQ code: PBMD) | ||
| Website address | www.primabiomed.com.au |
On behalf of the Board of Prima BioMed I am pleased to present the Annual Report for 2014/2015. We believe the past year has been the
most significant in our company s history and has laid the foundation for significant growth in shareholder value for the years ahead.
most significant events were the acquisition of Immutep SA, which completed in December 2014, and the A$15m investment by Ridgeback Capital Investments, announced in May 2015 and approved by shareholders in July 2015. Both your Board and management
regard these two events as transformative for Prima.
The acquisition of Immutep has provided us with a strong portfolio of LAG-3 assets, taking us
from being a single product company to a multi-product company. This is an important step in de-risking a small biotech company such as Prima.
investment by Ridgeback allows us to move our LAG-3 programs towards meaningful clinical and commercial outcomes which we believe will benefit all shareholders. Having such a reputable cornerstone investor on our share register will also help to
enhance Prima s visibility and reputation in the Life Sciences sector, especially in the US.
Since May 2015, approximately 30% of our shares
have been held by shareholders based in the US via our NASDAQ listed ADRs. We believe that the growth in our NASDAQ listed ADR holdings, reflects a positive re-rating of the Company following acquisition of Immutep and investment by Ridgeback.
Another important component of securing our near term financial security was the Share Purchase Plan, through which we successfully raised A$10 million.
We were delighted with the strong level of demand for shares in the SPP, which was over-subscribed. I would like to thank shareholders for their overwhelming support. This additional funding will help to offset any impact of the weakening Australian
dollar, with the majority of our research and development activities taking place in Europe.
One of the advantages of our dedicated research
laboratory being based outside Paris is that we benefit from significant R&D rebates from the French Government. The potential development of a continuing pipeline of LAG-3 related technologies from pre-clinical work undertaken in France could
provide considerable longer term value. Further value growth could be generated as we reach additional milestones from our existing development partners Novartis and GlaxoSmithKline.
Prima is now funded through to late calendar 2016, during which time we aim to have advanced development of our lead product, IMP321. We expect clinical
work by Prima on IMP321 to commence during the current financial year in two initial studies: a Phase IIb chemo-immunotherapy trial in metastatic breast cancer and a Phase I study in combination with an immune-checkpoint inhibitor.
Since year end we received positive Scientific Advice from the EMA, the agency responsible for the scientific evaluation of medicines developed by
pharmaceutical companies for use in the European Union, on the development path for IMP321 in metastatic breast cancer.
We are pleased that the two
pharmaceutical companies who have licensed two of our LAG-3 products, GlaxoSmithKline and Novartis, have now commenced clinical trials.
decision in February to consolidate our CVac program and to seek a partner for this asset was not taken lightly. We believe it was the responsible decision to make given the timelines we were facing, the cash available, and the need to
prioritise our programs. We appreciate that some shareholders were initially unsure of how to interpret this decision, but we believe they are now beginning to realise the value of the LAG-3 programs.
CHAIRMAN S LETTER CONTINUED
The merger and integration of Immutep and Prima has taken place quite seamlessly
this year with staff from both sides working well together. We of course welcomed Prof. Fr d ric Triebel and his Paris team to Prima and thank him for his dedicated service in the short time he has been with us.
Much of the transformation of Prima over the course of 2014/15 can be attributed to Marc Voigt, who we named as our CEO in July 2014. It was Marc who,
with the support of our General Counsel & Company Secretary, Deanne Miller, negotiated Immutep s acquisition at what we consider a very reasonable price. Marc has worked very hard to secure the Ridgeback investment, and carefully
plan a new direction for our Company that aligns with current trends in the immuno-oncology field. He has also brought together the team which is now taking Prima forward.
I would also like to thank the rest of the management team and my fellow directors for their hard work and dedication during this very busy past year.
Finally, I would like to express appreciation to all shareholders for their ongoing support. Many long-term shareholders have expressed to us their
view that the Immutep programs represent a worthwhile expenditure of shareholder funds, and I thank them for this confidence in the Prima Board and management team.
REVIEW OF OPERATIONS
On behalf of the Directors and Management team of Prima BioMed, I am pleased to report on our operations for the past financial year.
Operating and Financial Review
The fiscal year 2015 was
characterised by a number of significant milestones and changes. The most fundamental of these were the acquisition of Immutep, the commencement of the GlaxoSmithKline (GSK) Phase I clinical trial for its LAG-3 depleting antibody, the consolidation
of the CVac clinical trial program and the positive final overall survival data for the CAN-003 clinical trial of CVac.
I firmly believe that the
strategic changes we have been implementing in our Company this year have contributed towards a positive long-term outlook. The Ridgeback deal together with the Share Purchase Plan (SPP) announced on 7 July 2015 has secured sufficient funding
for the Company until at least late 2016. Future potential milestone payments from our development partners might also help to support the cash flows of the Company in future years. The strategic changes which have taken place have positioned the
company for future growth and the outlook for us going forward is encouraging.
Acquisition of Immutep SA
In December 2014 Prima finalized the acquisition of the French privately owned and venture capital backed company Immutep SA, a biopharmaceutical
company in the rapidly growing field of Immuno-Oncology. The completion followed shareholder approval at the Company s AGM on 14 November. The acquisition significantly expands Prima s clinical development product portfolio to other
categories of immunotherapies. It has also provided Prima with partnerships with several of the world s largest pharmaceutical companies.
acquisition, which was announced in October 2014, followed a due diligence process conducted by Prima team members and external advisors.
has three products candidates in development. They are based on a specific target called lymphocyte activation gene 3 or LAG-3, which is involved in the regulation of T cells in immune responses. Two of those products are fully partnered with
Novartis and GSK. Their most advanced product candidate, IMP321, will be developed by the Prima group for commercialisation in the world s major markets.
IMP321 is a recombinant protein that could be used in conjunction with chemotherapy to amplify a patient s immune response. The development and
manufacturing of IMP321 is being conducted in conjunction with Eddingpharm, which has licenced the rights for IMP321 for China and Taiwan.
Immutep s other products include IMP701, an antagonist antibody that acts to stimulate T cell proliferation in cancer patients, licensed to CoStim
(Novartis) and IMP731, a depleting antibody that removes T cells involved in autoimmunity, licensed to GSK.
In addition to these products Immutep
also has a dedicated R&D laboratory outside Paris with other research candidates in development.
The fair value of the total consideration paid
by Prima for the acquisition of Immutep is $26,253,103. The primary assets acquired in the acquisition of Immutep are Intellectual Property R&D assets of $23m. These assets will be amortised over the patent life of the assets acquired.
REVIEW OF OPERATIONS CONTINUED
We finished the financial year 2015 with approximately $6.76 million in cash and term deposits. Our grant funding from the Saxony Development Bank in
Germany ceased in December 2014, however we received other non-dilutive cash resources of $777,000 from the Australian R&D tax incentive program and approximately $320,000 in a similar scheme operated by the French Government called
Cr dit d Imp t Recherche for the LAG-3 program.
During FY 15 we raised a total of US$4m through a convertible security and an
equity funding line from the New York-based Bergen Asset Management. The original US$37.4m facility was vital to our success in negotiating the Immutep acquisition and was mutually terminated after the Ridgeback financing was completed on
Prima BioMed announced on 14 May 2015 that Ridgeback Capital Investments, a US-based specialist healthcare investor, would
be investing $15m in Prima. Ridgeback took an immediate placement of approximately 72 million Prima shares at 1.73 cents per share, worth $1.25m, and committed to investing the remainder of its $15m commitment via 3% convertible notes which
convert, at Ridgeback s election, into Prima ordinary shares at 2.00 cents per share. Shareholders approved this investment after the reporting period at an Extraordinary General Meeting on 31 July 2015, resulting in Prima receiving
approximately $14m subsequent to year-end. Concurrent with the Ridgeback investment Prima BioMed announced a Share Purchase Plan at 5 cents per share in July 2015 that raised an additional $10m subsequent to 30 June 2015.
As a result of the Ridgeback investment and the SPP, Prima has now received approximately $24m in cash which funds the company until late 2016.
Financial Performance
Total other income for FY15 was
$2,092,867 which was comparably lower than the $3,140,066 in FY14. The decrease is primarily attributable to grant income of $1,167,190 in FY15 compared to $2,004,198 in FY14 as a result of lower research and development expenditure. This decrease
is also impacted by a decrease in interest income being earned during FY15 ($219,107 compared to $713,311 in FY14).
Total corporate administrative
expense for FY15 was $5,723,106 ($4,092,623 in FY14). Expenses increased during the financial year primarily as a result of corporate advisory and administrative expenditure relating to the acquisition of Immutep and the implementation and
maintenance of the convertible note and equity funding line agreement with Bergen Global Opportunity Fund (Bergen Agreement).
product portfolio lead also to changes in our staff structure. We reduced our headcount during FY 15 by approximately 30%. During the year, we have managed to attract new talent which will certainly contribute to a successful future for our Company.
The vast majority of the R&D expenses in FY2015 were driven by our CVac clinical trial program. Our most significant expenses were, as in the
previous year, our contracts with the Contract Research Organisations (CRO) and Contract Manufacturing Organisations (CMO) who we engaged for our CVac clinical trial program. The R&D expenses amounted to $8,952,447 in the FY2015 compared to
$11,930,857 in the previous period. Our R&D costs are expected to increase over the next financial year as IMP321 clinical trials commence.
loss before income tax for FY2015 was $32,293,852 ($13,329,774 in FY2014). The loss was attributed to (non-cash) finance costs incurred during the year of $18.3m. Finance costs primarily relate to the Bergen Agreement as described above. A breakdown
of these expenses is detailed in note 18.
REVIEW OF OPERATIONS CONTINUED
Immutep s lead candidate IMP321 has successfully completed early phase II trials in metastatic breast cancer when used as a chemo-immunotherapy.
Prima intends to pursue development of IMP321 internally in a range of programs. The funds raised after the end of the FY2015 will collectively contribute towards working capital for the Company as well as the running of two new clinical trials: