THIRD QUARTER REPORT 2011 (UNAUDITED)

Transcription

1 THIRD QUARTER REPORT 2011 (UNAUDITED) Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 1

2 THIRD QUARTER REPORT 2011 HIGHLIGHTS On the 25th August Bionor Pharma announced that the company had entered into a research agreement to combine Revlimid, one of the world s leading cancer drugs, with Vacc-4x in a new co-financed clinical trial on HIV patients. The trial aims to investigate if the effect of Vacc-4x can be enhanced when immunising a patient group with low CD4 counts that has special need for improved treatment. The main results from the Vacc-4x phase IIB trial were presented at the International AIDS Society conference in Rome, at AIDS Vaccine 2011 in Bangkok and the Norwegian Research Council s GLOBVAC programme meeting in Oslo. The clinical and immunological data presented showed a statistically significant reduction in viral load in HIV patients treated with Vacc-4x due to improved immune responses. A new board of directors was elected on the 25th July with Lars Høie (chairman), Inga Kaasen, Bjørn Fuglaas, Marianne Furru and Erik Danielsen. On 15th September Steen Krøyer started as interim CEO in the company. Steen Krøyer will serve as CEO until a permanent CEO is hired. After this the intention is that Steen Krøyer will join the board of directors. EBITDA in Q was MNOK compared to MNOK in Q2. The operating expenses were higher than the previous quarters mainly due to accrued costs for the analyses of phase IIB trial and preparation for new clinical trials. An application to SkatteFUNN regarding Vacc-C5 was granted. Expected tax reduction for the three year period is approximately 3 MNOK. Cash at end of Q3 was MNOK compared to MNOK at the end of Q2. FINANCIAL STATEMENT The consolidated financial figures are: Q Q (In NOK 1000) 9M M 2010 FY Revenue Other operating expenses (net) EBITDA Depreciation Write-down of intangible assets EBIT * Note that 2010-figures include consolidated figures for Bionor Immuno AS from date of purchase, 18 th February Revenues in Q3 were mainly sales of Nutri5 and NutriPro to Nikken of MNOK 1.1. Other operating expenses in Q3 were MNOK 15.5, compared to MNOK 11.0 in Q2. Other operating expenses were higher than in the past quarters due to accrued costs for analyses in the phase IIB trial and preparation for new clinical trials. The clinical costs including peptide costs in Q3 were MNOK 4.1 and pre-clinical costs were MNOK 5.3. Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 2

3 EBITDA in Q was MNOK -14.2, compared to MNOK i Q2. EBIT in Q3 was MNOK 17.1 after reduction of depreciation of MNOK 2.8. Net financial income in Q3 was MNOK 0.8 compared to MNOK 0.5 in Q2. Cash at end of Q3 was MNOK and shows a reduction of MNOK 11.0 from MNOK at end of Q2. VACCINES - OVERVIEW AND STATUS The operating expenses for the vaccine segment consist of clinical and preclinical costs in addition to running the organisation. The workload and costs in Q3 have mainly been allocated to the following projects: Vacc-4x phase IIB trial. Further analyses of clinical and immunological results. The costs of the analyses and evaluating the results were MNOK 3.3 in Q3. Vacc-C5. The finalisation of tox testing and preclinical analyses was according to plan with costs of MNOK 0.6 in Q3. Further laboratory analyses have been done to further support the patent applications regarding the company s platform technologies. This work will continue throughout Presentation of clinical and immunological data from Vacc-4x phase IIB trial Bionor Pharma presented during Q3, data from the phase IIB trial at the International AIDS Society conference in Rome July, at the AIDS Vaccine 2011 meeting September in Bangkok and at the Norwegian Research Council s GLOBVAC programme meeting in Oslo September. The clinical data show as previously announced, a statistically significant reduction in viral load of 70% for immunised patients compared to the level they had before starting conventional HIVmedication. The study shows also a statistically significant reduction in viral load during the study period between the Vacc-4x and placebo groups. The clinical results are supported by the immunological data announced earlier. ELISPOT, as the benchmark -method for measuring immune stimulation in individual patients, showed that among patients with positive responses against the region in the HIV virus that the vaccine is targeting (p24), that the immunized group had significantly larger reduction in viral load compared to the placebo group. This confirms even further that Vacc-4x can improve the patient s immune responses towards the HIV virus. At AIDS Vaccine 2011 in Bangkok Bionor Pharma was, as the only company within therapeutic vaccines, specially invited by Global HIV Vaccine Enterprise (GHVE) to present the phase IIB data at their press conference. GHVE is a unique alliance of more than thirty independent research organisations, NGO s, public institutions and private companies, cooperating to accelerate the development of more effective vaccines. The invitation from GHVE is regarded as confirmation of Bionor Pharma s strong position internationally within the HIV vaccine field. Vacc-4x Revlimid study As announced on the 25th August Bionor Pharma has entered into an agreement with Celgene to use Revlimid, in combination with Vacc-4x in a new co-financed clinical trial. Revlimid is one of the world s leading cancer drugs with a sale of approximately USD 3 billion per year and with a 35% annual growth rate. Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 3

4 Revlimid has previously showed an ability to generally stimulate the immune system, and the purpose of the trial is to test whether the effect of Vacc-4x can be further strengthened when the combination is used in an HIV immune compromised patient group who have failed to regain immune competence on conventional HIV medicine (ART). The Revlimid trial aims to give information important for evaluating the future development program for Vacc-4x, and is one of several options for the development of a concept of continuous viral control ( functional cure ). SOYA-PRODUCTS - OVERVIEW AND STATUS The revenues in Q3 were MNOK 1.1, mainly from sale of Nutri5 to Nikken for the European market and sale of NutriPro to Nikken in Russia. In comparison the sale in Q2 was MNOK 0.6 and only related to NutriPro. The sale of Nutri5 is the first since Nikken s launch in The Nikken s stock of goods purchased at the launch is now sold out. EBITDA for Soya-products in Q3 was MNOK EVENTS AFTER Q3 Presentation at the Influenza Congress USA 2011 The conference, held November, had invited Bionor Pharma to present its peptide-based universal influenza vaccine. This vaccine is designed, but is still at the preclinical stage of development. Based on encouraging preclinical data and positive feedback at the conference, Bionor Pharma has decided to look at the possibility of entering into a license agreement with a partner that can fund the further development of Bionor Pharma s influenza vaccine candidate. Initiation of Vacc-4x trial using nasal administration This trial, is being carried out at Oslo University Hospital and is co-financed by the Norwegian Research Council. The first patient was vaccinated on the 3 rd November Vacc-HCV The product Vacc-HCV is defined and is ready for production and toxicological analyses. VACCINES OUTLOOK Immunological analyses from the Vacc-4x phase IIB trial are ongoing and are expected to give further insight into the immunological mechanisms behind the statistically significant reduction in viral load and provide Bionor with better insight into which patient groups can be expected to have greatest benefit from Vacc-4x. A report with the main conclusions from the phase IIB trial is expected in the Q and will provide information important for preparing for a phase III clinical programme. In the first half of 2012 Bionor Pharma will start an extensive clinical research programme that includes: Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 4

5 o o o o Vacc-4x and Revlimid in combination Vacc-4x reimmunisation Completion of the Vacc-4x trial involving nasal administration Vacc-C5 first time in man phase I/II trial Vacc-4x is developed to stimulate the body s own immune system. A reimmunisation with Vacc- 4x planned in Q aims to reduce viral load even further providing support for a Functional cure. This is a regularly treatment that controls the infection without side effects normally associated with today s management of HIV infection. Vacc-C5 is developed to control immune hyperactivation associated with HIV infection. Vacc-C5 planned to enter into the clinic in Q aims to induce antibodies to HIV that can reduce immune hyperactivation. It is previously been shown that patients with antibodies to the C5 region on HIV, have little virus in their blood and slow disease progression. Vacc-4x in combination with Vacc-C5 can potentially revolutionise the management of HIV infection and could form the basis for a preventative vaccine. Further development of vaccine candidates for HCV, influenza and potentially virus associated cancer (HPV, CMV) will most likely be carried out in collaboration with a partner. Bionor Pharma aims to enter into a commercial agreement with a global pharmaceutical company in the course of expenses are expected to increase somewhat due to the initiation of new clinical trials on Vacc-4x and Vacc-C5 as well as preclinical development of Vacc-HCV and Vacc-Flu. SOYA-PRODUCTS Sales revenues Nikken Bionor Pharma expects a moderate growth of NutriPro in Russia over the next quarters. Since May 2009 Nutri5 has been distributed in the majority of Europe via Nikken with limited success so far. However, Bionor expects sale of Nutri5 to increase because Nikken s stock since the launch is now sold out. The first delivery was in Q3 and further deliveries are expected in Business development The activity of appointing several new international distribution partners for the weight reduction products (NutriPro) continues. Bionor has entered into a Letter of Intent with a potential partner for distribution of NutriPro in China. FOR FURTHER INFORMATION: Steen Krøyer, CEO Gunnar Flåten, SVP Finance & Administration / Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 5

6 The figures in all tables are unaudited. Consolidated income statement For the period ended 30 September CONSOLIDATED FINANCIAL STATEMENT Q Q In NOK thousands 9M M 2010 FY Operating revenue (823) (366) Cost of goods (1 535) (383) (762) (7 018) (4 476) Employee benefits expense (15 929) (11 857) (18 945) (2 834) (2 413) Depreciation and amortisation (8 466) (7 386) (9 224) (7 617) (3 985) Other operating expenses (19 818) (22 527) (28 131) (17 056) (8 113) Operating profit (loss) (33 518) (44 471) Finance income (436) (606) Finance costs (1 532) (1 568) (4 644) (16 301) (8 413) Profit (loss) before tax (34 451) (47 452) - (84 658) Write-down of intangible assets (84 658) (3) - - Income tax (charge) / credit - (1) Profit/loss from discontinued operations (16 301) (93 071) Profit (loss) for the year ( ) (47 455) - - Attributable to: (16 301) (93 071) Equity holders of the parent (47 455) Earnings (loss) per share (NOK) for continued and discontinued operations: (0,09) (0,77) - Basic 0,37 (0,99) (0,28) (0,09) (0,77) - Diluted 0,37 (0,99) (0,28) Earnings (loss) per share (NOK) for continued operations: (0,09) (0,07) - Basic 0,37 (0,29) (0,26) (0,09) (0,07) - Diluted 0,37 (0,29) (0,26) Consolidated statement of comprehensive income For the period ended 30 September Q Q In NOK thousands 9M M 2010 FY 2010 (16 301) (93 071) Profit for the year ( ) (47 455) Other comprehensive income: - - Currency translation effect (105) Other comprehensive income - (105) - (16 301) (93 071) Total comprehensive income ( ) (47 455) Attributable to: (16 301) (93 071) Equity holders of the parent ( ) (47 455) Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 6

7 Consolidated statement of financial position For the period ended 30 September In NOK thousands 30 September 30 September ASSETS Non-current assets Goodwill Intangible assets Property, plant and equipment Loans and receivables 478 Total non-current assets Current assets Trade and other receivables Cash and cash equivalents Total current assets TOTAL ASSETS EQUITY AND LIABILITIES Equity Paid in capital Own shares - - Translation adjustment - (105) Retained earnings ( ) Total equity Non-current liabilities Deferred tax liability - Interest-bearing loans and borrowings Total non-current liabilities Current liabilities Trade and other payables Total current liabilities Total liabilities TOTAL EQUITY AND LIABILITIES Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 7

8 Consolidated cash flow statement For the period ended 30 September Net cash flows (used in)/from operating activities (30 954) ( ) Investing activities Cash from business combinations Sales of financial assets (24) Write-down of intangible assets Purchase of property, plant and equipment (678) Sales of intangible assets Net cash flows (used in)/from investing activities Financing activities Proceeds from issue of share capital Loan instalments (3 000) (5 000) Net cash flows (used in)/from financing activities (3 000) Net cash from discontinued operations Net increase/(decrease) in cash and cash equivalents Effect of exchange rate changes on cash and cash equivalents Cash and cash equivalents at 1 January Cash and cash equivalents at 30 September Consolidated statement of changes in equity For the period ended 30 September In NOK thousands Share capital Share premium Other paidin capital Own shares Translation adjustment Retained earnings Total equity Equity at 1 January Share-based payment Total comprehensive income for the year Issue of share capital - Exercise of options and warrants - Equity at 30 September Paid in capital Share capital Share premium Other paidin capital Own shares Translation adjustment Retained earnings Total equity Equity at 1 January (24 376) Share-based payment Total comprehensive income for the year (105) ( ) ( ) Issue of share capital Exercise of options and warrants (9 373) (9 373) Equity at 30 September (105) ( ) Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 8

9 Notes to the consolidated financial statement 1. Basis for preparation The financial statements have been prepared in accordance with International Accounting Standard 34 Interim Financial Reporting. The financial statements have been prepared under the historical cost convention. The same accounting policies, presentation, methods of computation have been followed in these condensed financial statements as were applied in the preparation of the group s financial statement for the year ended The Annual report for 2010 can be obtained upon request to the company s head office, or from its website: 2. Segment information Going forward, Bionor Pharma reports on two business segments; vaccine development and soy-based products. These business segments are organized in three separate companies, and the wholly owned subsidiaries Bionor Immuno AS and Nutri Pharma AS. Transfer prices between business segments are set on an arm's length basis in a manner similar to transactions with third parties. Segment revenue, segment expense, segment result, segment assets and liabilities include transfers between business segments. Those transfers are eliminated in consolidation. Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 9

10 Segment information The (NOK primary 1000) reporting format is dtermined to be business segments as the Grou Operating revenue by segment 9M M 2010 FY 2010 Soy based product Vaccines Total operating revenue EBITDA by segment 9M M 2010 FY 2010 Soy based product Vaccines Non-allocated corporate cost Total EBITDA Depreciation per segment: Soy based product Vaccines Total depreciation Net finance income/cost per segment: Soy based product Vaccines Non allocated and intercompany Total finance results Results before tax S egment assets 9M M 2010 FY 2010 Soy based product Vaccines Eliminations Total assets S egment liabilities 9M M 2010 FY 2010 Soy based product Vaccines Eliminations Total liabilities Please note that the 2010 figures include consolidated figures from Bionor Immuno AS from the acquisition date, which was 18 February Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 10

11 Sale of soy based products in different markets Revenue by category Norway Scandianvia Europe + Russia 9M M M M M M 2010 Royalty Product sales Sale of Nutrilett Total Kronprinsesse Märthas pl. 1, Vika, 0166 Oslo, Norway. Tel: , Page 11