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Vivesto — Interim / Quarterly Report 2011
Aug 27, 2012
3124_10-q_2012-08-27_f98041a8-e664-4e20-bc63-50b8766709e6.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2011 €
Pages 1-9 is a service to shareholders in the euro zone. It is not the official report in the functional currency of Oasmia, which is SEK, but the first nine pages of that report converted to EUR. The full official report will be found on pages 10-23. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as of July 31, 2011 which was 9.0913 SEK per one EUR. The text in page 5 include a few figures in SEK because they are very firmly denominated in SEK.
POSITIVE PHASE III RESULTS FOR PACLICAL®
FIRST QUARTER May 1 – July 31, 2011
- Consolidated net sales amounted to € 98 thousands (5) 1
- Operating income amounted to € -1,690 thousands (-1,234)
- Net income after tax amounted to € -1,679 thousands (-1,330)
- Earnings per share was € -0.03 (-0.03)
- Comprehensive income amounted to € -1,679 thousands (-1,330)
- Positive results from an interim analysis of Paclical®
- Licence agreement signed for Paclical® in Israel and Turkey
EVENTS AFTER CLOSING DAY
• Oasmia and Orion terminates collaboration for Paclical® in the Nordic region
1 The numbers in parentheses concerns results for the corresponding period previous year
BUSINESS ACTIVTIES IN THE PERIOD
HUMAN HEALTH
Oasmia has three product candidates for the human market under development.
Paclical®
In May 2011, a license agreement was closed with Medison Pharma for Paclical® in Israel and Turkey.
The international Phase III study on ovarian cancer commenced in February 2009 has continued in the period. In the study, the company's pharmaceutical candidate Paclical® is compared to the well-known pharmaceutical Taxol®. The study currently comprises approximately 80 clinics in 16 European countries and includes 650 patients. Oasmia performed an interim analysis in the period which comprised 400 patients. The result fulfilled the placed clinical requirement, that Paclical® should be at least as effective as Taxol®.
Important differences between treatments with these two preparations are as follows:
- Extensive premedication is necessary for Taxol® in order to avoid hypersensitivity reactions due to the solvent Cremophor® EL. This is not necessary for Paclical®.
- The infusion time for Paclical® is one hour and for Taxol® three hours.
- Paclical® can be administered in a higher dose (250 mg/m2 ) compared to Taxol® (175 mg/m2 )
The results from the interim analysis will constitute the grounds for application of market registration in the EU, Israel and Turkey as well as growth markets such as Russia and some Asian countries. Oasmia aims to submit such applications in the coming six months.
The on-going Phase III study continues to gather further clinical information such as progression free survival and overall survival. All 650 patients will be enrolled in September 2011.
Paclical® is previously designated as an Orphan Drug by the EMA (EU) and FDA (USA) for the indication ovarian cancer. Orphan Drug designation is granted for small indications and entails seven years' market exclusivity for the indication when a market approval is obtained.
Doxophos®
Doxophos® is a novel patented formulation of doxorubicin, one of the most effective and used substances for treatment of cancer. Currently, doxorubicin is used for treatment of 20 different types of cancer. Pre-clinical studies have been completed and based on this, the company will start a clinical Phase I study in 2011.
Docecal®
Docecal® is a new patented formulation of docetaxel (Taxotere®) with improved chemical properties compared to Taxotere®. Oasmia intends to focus on the same indications as Taxotere®, i.e. breast cancer, prostate cancer and non-small cell lung cancer. Preparations are underway to begin a Phase I study with the product candidate commencing in nine months.
ANIMAL HEALTH
Oasmia has two product candidates in development for the veterinary market.
Paccal® Vet
In August 2010, Oasmia submitted an application of registration for Paccal® Vet in the EU and the USA for treatment of mastocytoma in dogs. The time of review was estimated by the EMA to be about one year and Oasmia is expecting information of a market approval from the EMA before the end of 2011.
The registration file states that the product will be manufactured in the in-house facility in Uppsala. There has not been any previous commercial manufacturing in this facility (only for clinical trials) which has led to a situation where FDA review is taking considerably more time than anticipated. We are now expecting to make a statement about the probable time for market approval from the FDA in the autumn of 2011.
In June 2011, Paccal® Vet was granted a MUMS-designation (minor use/minor species) by the FDA for squamous cell carcinoma. The product candidate also holds this designation for mastocytoma. MUMS is granted by the FDA for either a minor use within a numerous species (such as dogs) or for treatment of a minor species. The most interesting aspect of this designation is the possibility of seven years of market exclusivity as of the approval time of the product.
Doxophos® Vet
Doxophos® Vet is intended for treatment of lymphoma in dogs. In June 2011, Oasmia received approval from the regulatory authorities in Germany and Austria to start a Phase I study. The study started in the summer of 2011.
EVENTS AFTER THE CLOSING DAY
Oasmia and Orion concludes collaboration for Paclical®
In August 2011, Oasmia and Orion decided to terminate the collaboration for Paclical®. The license agreement signed by the parties in 2007 concerned the Nordic countries. The distribution rights have returned to Oasmia, who now have greater freedom of action in the European market.
FINANCIAL PROSPECTS
Crucial for Oasmia's financial prospects are the registration dates for the products that the company develops. After submission of the application for registration, Oasmia is dependent on the pharmaceutical authorities' management of the case. The company cannot expedite the process in any other way than to submit answers to the authorities' questions, which may be asked at various times in the registration process, as quickly as possible.
The company now aims to launch the first product for the human market, Paclical® and the first product for the veterinary market, Paccal® Vet, in one or more regions in 2012. For the latter, the previous aim was to launch in 2011, but registration has not been obtained in time for that.
One part of Oasmia's business model is to license sales rights to companies which have the right resources for marketing and sales. In addition to already closed license agreements, Oasmia estimates that there are very good conditions for further licensing for interesting regions.
The company has set a goal that the debt/equity ratio shall not exceed 50 %. At the end of the fiscal year (July 31), the debt/equity ratio was 0%.
BUSINESS ACTIVITIES
Oasmia develops a new generation of pharmaceuticals within human and veterinary oncology. The product development aims to manufacture novel formulations of well-established cytostatics which, compared to current alternatives, have improved properties, a reduced side-effect profile, and a wider therapeutic spectrum. The product development is based on in-house research within nanotechnology and company patents. The company's most essential patents are global and expire in 2023. Further patent applications have been submitted to protect Oasmia's technology and new formulations which could extend the patent protection to the year 2028. Oasmia has now started to receive such approvals.
One part of Oasmia's business model is taking responsibility for the supply chain – from product idea to final product and licensing of sales rights, to companies who have the right resources for marketing and sales.
The product candidates undergo clinical trials controlled by Oasmia personnel who commit clinics and contract research organizations (CRO). Thereafter, an application for registration of the product for sales on the market follows. In such an application, the product and its manufacturing process are included.
Oasmia's in-house production facility is used for production of pharmaceuticals for clinical trials. It may also be used for small scale commercial production of pharmaceuticals. The application submitted in the USA and the EU for registration of Paccal® Vet is based on manufacturing of the product in the facility in Uppsala. To provide the
market with larger volumes in the future, Oasmia has closed an agreement with a contract manufacturer, Baxter Oncology, who has a much greater production capacity compared to the in-house facility. This kind of change in manufacturing unit requires a specific approval from pharmaceutical authorities.
For upcoming products, such as Paclical®, the intention is to apply for approval with a contract manufacturer as producer of the pharmaceutical from the beginning.
Final labelling, packing and distribution will be made from the in-house facility in Uppsala in order to ensure that all markets are continuously supplied with products.
FINANCAL INFORMATION
Consolidated Income Statement in brief
| 2011 | 2010 | 2010/11 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Net sales | 98 | 5 | 12 |
| Capitalized development cost | 2,209 | 2,202 | 9,465 |
| Operating income | -1,690 | -1,234 | -7,079 |
| Net income after tax | -1,679 | -1,330 | -7,255 |
| Earnings per share (€), before and after dilution* | -0.03 | -0.03 | -0.16 |
| Comprehensive income for the period | -1,679 | -1,330 | -7,255 |
* Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2010/2011.
Net sales
Net sales for the fiscal year amounted to € 98 thousands (5) and consisted of license revenue in connection to closing an agreement with Medison Pharma.
Capitalized development cost
Capitalized development cost consists of the company's investments in clinical Phase III trials. They amounted to € 2,209 thousands (2,202) for the period and concerned Paclical® only.
Capitalization of Paccal® Vet was concluded at the end of the last fiscal year, since an application of registration of Paccal® Vet was submitted in August 2010 and any development work contributing further economic value to the product candidate is no longer performed.
Operating expenses
The total operating expenses excluding depreciation and impairment amounted to € 3,863 thousands (3,326). The increase in expenses is attributable to an increased intensity in the Phase III study for Paclical®. Of these operating expenses, 57 % (66) were capitalized as Capitalized development cost. The share of capitalized operating expenses has decreased successively since Paccal® Vet was submitted for registration. The number of employees was 70 (69) at the end of the quarter.
Income for the period
Net income for the quarter was € -1,679 thousands (-1,330). The increase in loss is attributable to the reduction in capitalized development cost.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Financial position
The consolidated liquid assets at the end of the quarter amounted to € 2,212 thousands (12). Equity at the same time amounted to € 30,679 thousands (14,268). At the end of the quarter, the equity/assets ratio was 91 % (67) and the debt/equity ratio 0 % (32). The company has unutilized credits amounting to TSEK 45 000 and an unutilized SEDA-agreement (standby equity distribution agreement) amounting to TSEK 75 000.
Cash flow and Capital expenditures
Cash flow from operating activities in the quarter amounted to € -1,203 thousands (-998). The change compared to the previous year consisted of increased operational expenditures.
Capital expenditures amounted to € 2,391 thousands (2,517) where investments in intangible assets amounted to € 2,226 thousands (2,202) and investments in property, plant and equipment amounted to € 165 thousands (315). Investments in intangible assets consisted of capitalized development costs € 2,209 thousands and patents € 17 thousands. Investments in property, plant and equipment mainly concerned production equipment. Starting in the past quarter, Oasmia also invests in production equipment in Baxter Oncology in addition to Uppsala.
Financing in the quarter was performed by use of liquid assets.
The parent company
The parent company net sales in the quarter amounted to € 98 thousands (5) and net income after tax amounted to € -1,671 thousands (-1,332). The parent company liquid assets at the end of the period amounted to € 2,210 thousands (3).
Key ratios and other information
| 2011 | 2010 | 2010/11 | |
|---|---|---|---|
| May-July | May-July | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* | 52,079 | 38,403 | 52,079 |
| Average number of shares (in thousands) before and after dilution* | 52,079 | 38,403 | 44,061 |
| Earnings per share in €, before and after dilution* | -0.03 | -0.03 | -0.16 |
| Equity per share, €* | 0.59 | 0.37 | 0.62 |
| Equity/Assets ratio, % | 91 | 67 | 92 |
| Net liability, € thousands | -2,212 | 4,557 | -5,708 |
| Debt/Equity ratio, % | - | 32 | - |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 70 | 69 | 68 |
* Recalculation of historical values has been made with respect to capitalization issue elements in the preferential rights share issue carried out in the second quarter 2009/10 and third quarter 2010/11.
Definitions
Earnings per share, before and after dilution: The income for the period attributable to the equity holders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity in comparison with the number of shares at the end of the period
Equity/assets ratio: Equity pertaining to the balance sheet total. Net liability: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deductions for liquid funds
Debt/Equity ratio: Net liability with respect to equity.
Return on total equity: Income for interest expenses pertaining to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2011 | 2010 | 2010/11 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Net sales | 98 | 5 | 12 |
| Capitalized development cost | 2,209 | 2,202 | 9,465 |
| Other operating income | 5 | 3 | 30 |
| Raw materials, consumables and goods for resale | -402 | -293 | -1,773 |
| Other external expenses | -2,359 | -1,995 | -10,172 |
| Employee benefit expenses | -1,103 | -1,039 | -4,111 |
| Depreciation/amortization and impairment | -139 | -117 | -514 |
| Other operating expenses | - | - | -15 |
| Operating income | -1,690 | -1,234 | -7,079 |
| Financial income | 14 | 2 | 53 |
| Financial expenses | -3 | -98 | -231 |
| Financial items, net | 12 | -96 | -177 |
| Income before taxes | -1,679 | -1,330 | -7,256 |
| Taxes | - | 0 | 1 |
| Income for the period | -1,679 | -1,330 | -7,255 |
| Income for the period attributable to: | |||
| Equity holders of the Parent company | -1,679 | -1,330 | -7,255 |
| Non-controlling interest | - | 0 | - |
| Earnings per share | |||
| Before dilution, € | -0.03 | -0.03 | -0.16 |
| After dilution, € | -0.03 | -0.03 | -0.16 |
Consolidated Statement of Comprehensive income
| 2011 | 2010 | 2010/11 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Income for the period | -1,679 | -1,330 | -7,255 |
| Comprehensive income for the period | -1,679 | -1,330 | -7,255 |
| Income for the period attributable to: | |||
| Equity holders of the Parent company | -1,679 | -1,330 | -7,255 |
| Non-controlling interest | - | 0 | - |
| Comprehensive Earnings per share | |||
| Before dilution, € | -0.03 | -0.03 | -0.16 |
| After dilution, € | -0.03 | -0.03 | -0.16 |
Consolidated statement of financial position
| € thousands | 2011-07-31 | 2010-07-31 | 2011-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 3,048 | 2,495 | 2,997 |
| Capitalized development cost | 27,168 | 17,696 | 24,959 |
| Other intangible assets | 1,012 | 861 | 1,020 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 31,228 | 21,053 | 28,976 |
| Current assets | |||
| Inventories | - | 10 | - |
| Trade receivables | 142 | 146 | 235 |
| Prepaid expenses and accrued income | 269 | 133 | 314 |
| Liquid assets | 2,212 | 12 | 5,708 |
| Total Current assets | 2,623 | 301 | 6,258 |
| TOTAL ASSETS | 33,851 | 21,354 | 35,234 |
| EQUITY | |||
| Equity attributed to equity holders in the Parent Company | |||
| Share capital | 573 | 414 | 573 |
| Other capital provided | 45,469 | 21,613 | 45,469 |
| Retained earnings | -15,363 | -7,765 | -13,685 |
| Total | 30,679 | 14,262 | 32,357 |
| Non-controlling interest | - | 6 | - |
| Total equity | 30,679 | 14,268 | 32,357 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 1,789 | 1,694 | 1,691 |
| Deferred tax liabilities | - | 1 | - |
| Total Non-current liabilities | 1,789 | 1,694 | 1,691 |
| Current liabilities | |||
| Liabilities to credit institutions | - | 548 | - |
| Short-term borrowings | - | 4,020 | - |
| Trade payables | 555 | 67 | 421 |
| Other current liabilities | 146 | 159 | 154 |
| Accrued expenses and prepaid income | 683 | 596 | 610 |
| Total Current liabilities | 1,383 | 5,391 | 1,185 |
| Total Liabilities | 3,172 | 7,086 | 2,876 |
| TOTAL EQUITY AND LIABILITIES | 33,851 | 21,354 | 35,234 |
Consolidated statement of changes in equity
| Attributable to equity holders in Parent com | |||||
|---|---|---|---|---|---|
| pany | |||||
| Other | |||||
| paid-up | Non-controlling | ||||
| € thousands | Share capital | capital Retained earnings | interest | Total equity | |
| Opening balance as of May 1 2010 | 414 | 21,613 | -6,436 | 6 | 15,598 |
| Comprehensive income for the period | - | - | -1,330 | 0 | -1,330 |
| Closing balance as of July 31, 2010 | 414 | 21,613 | -7,765 | 6 | 14,268 |
| Opening balance as of May 1, 2010 | 414 | 21,613 | -6,436 | 6 | 15,598 |
| Comprehensive income for the period | - | - | -7,255 | - | -7,255 |
| Acquired non-controlling interest | - | - | 6 | -6 | 0 |
| New share issue | 159 | 26,096 | - | - | 26,256 |
| Issue expenses | - | -2,240 | - | - | -2,240 |
| Closing balance as of April 30, 2011 | 573 | 45,469 | -13,685 | 0 | 32,357 |
| Opening balance as of May 1, 2011 | 573 | 45,469 | -13,685 | 0 | 32,357 |
| Comprehensive income for the period | - | - | -1,679 | - | -1,679 |
| Closing balance as of July 31, 2011 | 573 | 45,469 | -15,363 | 0 | 30,679 |
| Consolidated Cash flow statement | |||||
| 2011 | 2010 | 2010/11 | |||
| € thousands | May-July | May-July | May-April | ||
| Operating activities | |||||
| Operating income before financial items | -1,690 | -1,234 | -7,079 | ||
| Depreciation/amortization | 139 | 117 | 511 | ||
| Impairment of inventory | - | - | 10 | ||
| Disposals of intangible assets | - | - | 15 | ||
| Interest received | 14 | 2 | 53 | ||
| Interest paid | -3 | -98 | -153 | ||
| Cash flow from operating activities before work ing capital changes |
-1,540 | -1,213 | -6,642 | ||
| Change in working capital | |||||
| Change in trade receivables | - | 7 | 7 | ||
| Change in other current receivables | 138 | 221 | -49 | ||
| Change in trade payables | 133 | -161 | 193 | ||
| Change in other current liabilities | 65 | 147 | 156 | ||
| Cash flow from operating activities | -1,203 | -998 | -6,336 | ||
| Investing activities | |||||
| Investments in intangible fixed assets | -2,226 | -2,202 | -9,717 | ||
| Investments in property, plant and equipment | -165 | -315 | -1,135 | ||
| Cash flow from investing activities | -2,391 | -2,517 | -10,852 | ||
| Financing activities | |||||
| Increase in liabilities to credit institutions | - | 77 | - | ||
| Decrease in liabilities to credit institutions | - | - | -472 | ||
| Increase in long-term liabilities | 98 | - | - | ||
| New share issue | - | - | 18,556 | ||
| Issue expenses | - | - | -2,240 | ||
| New loans | - | 2,860 | 6,462 | ||
| Cash flow from financing activities | 98 | 2,936 | 22,305 | ||
| Cash flow for the period Cash and cash equivalents at the beginning of |
-3,496 | -579 | 5,117 |
the period 5,708 591 591
period 2,212 12 5,708
Cash and cash equivalents at the end of the
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2011
POSITIVE PHASE III RESULTS FOR PACLICAL®
FIRST QUARTER May 1 – July 31, 2011
- Consolidated net sales amounted to TSEK 891 (42) 2
- Operating income amounted to TSEK -15 368 (-11 216)
- Net income after tax amounted to TSEK -15 260 (-12 090)
- Earnings per share was SEK -0,29 (-0,31)
- Comprehensive income amounted to TSEK -15 260 (-12 090)
- Positive results from an interim analysis of Paclical®
- Licence agreement signed for Paclical® in Israel and Turkey
EVENTS AFTER CLOSING DAY
• Oasmia and Orion terminates collaboration for Paclical® in the Nordic region
2 The numbers in parentheses concerns results for the corresponding period previous year
BUSINESS ACTIVTIES IN THE PERIOD
HUMAN HEALTH
Oasmia has three product candidates in development for the human market
Paclical®
In May 2011, a license agreement was closed with Medison Pharma for Paclical® in Israel and Turkey.
The international Phase III study on ovarian cancer commenced in February 2009 has continued in the period. In the study, the company's pharmaceutical candidate Paclical® is compared to the well-known pharmaceutical Taxol®®. The study currently comprises approximately 80 clinics in 16 European countries and includes 650 patients. Oasmia performed an interim analysis in the period which comprised 400 patients. The result fulfilled the placed clinical requirement, that Paclical® should be at least as effective as Taxol®.
Important differences between treatments with these two preparations are as follows:
- Extensive premedication is necessary for Taxol® in order to avoid hypersensitivity reactions due to the solvent Cremophor® EL. This is not necessary for Paclical®.
- The infusion time for Paclical® is one hour and for Taxol® three hours.
- Paclical® can be administered in a higher dose (250 mg/m2 ) compared to Taxol® (175 mg/m2 )
The results from the interim analysis will constitute the grounds for application of market registration in the EU, Israel and Turkey as well as growth markets such as Russia and some Asian countries. Oasmia aims to submit such applications in the coming six months.
The on-going Phase III study continues to gather further clinical information such as progression free survival and overall survival. All 650 patients will be enrolled in September 2011.
Paclical® is previously designated as an Orphan Drug by the EMA (EU) and FDA (USA) for the indication ovarian cancer. Orphan Drug designation is granted for small indications and entails seven years' market exclusivity for the indication when a market approval is obtained.
Doxophos®
Doxophos® is a novel patented formulation of doxorubicin, one of the most effective and used substances for treatment of cancer. Currently, doxorubicin is used for treatment of 20 different types of cancer. Pre-clinical studies have been completed and based on this, the company will start a clinical Phase I study in 2011.
Docecal®
Docecal® is a new patented formulation of docetaxel (Taxotere®) with improved chemical properties compared to Taxotere®. Oasmia intends to focus on the same indications as Taxotere®, i.e. breast cancer, prostate cancer and non-small cell lung cancer. Preparations are underway to begin a Phase I study with the product candidate commencing in nine months.
ANIMAL HEALTH
Oasmia has two product candidates in development for the veterinary market.
Paccal® Vet
In August 2010, Oasmia submitted an application of registration for Paccal® Vet in the EU and the USA for treatment of mastocytoma in dogs. The time of review was estimated by the EMA to be about one year and Oasmia is expecting information of a market approval from the EMA before the end of 2011.
The registration file states that the product will be manufactured in the in-house facility in Uppsala. There has not been any previous commercial manufacturing in this facility (only for clinical trials) which has led to a situation where FDA review is taking considerably more time than anticipated. We are now expecting to make a statement about the probable time for market approval from the FDA in the autumn of 2011.
In June 2011, Paccal® Vet was granted a MUMS-designation (minor use/minor species) by the FDA for squamous cell carcinoma. The product candidate also holds this designation for mastocytoma. MUMS is granted by the FDA for either a minor use within a numerous species (such as dogs) or for treatment of a minor species. The most interesting aspect of this designation is the possibility of seven years of market exclusivity as of the approval time of the product.
Doxophos® Vet
Doxophos® ® Vet is intended for treatment of lymphoma in dogs. In June 2011, Oasmia received approval from the regulatory authorities in Germany and Austria to start a Phase I study. The study started in the summer of 2011.
EVENTS AFTER THE CLOSING DAY
Oasmia and Orion concludes collaboration for Paclical®
In August 2011, Oasmia and Orion decided to terminate the collaboration for Paclical®. The license agreement signed by the parties in 2007 concerned the Nordic countries. The distribution rights have returned to Oasmia, who now have greater freedom of action in the European market.
FINANCIAL PROSPECTS
Crucial for Oasmia's financial prospects are the registration dates for the products that the company develops. After submission of the application for registration, Oasmia is dependent on the pharmaceutical authorities' management of the case. The company cannot expedite the process in any other way than to submit answers to the authorities' questions, which may be asked at various times in the registration process, as quickly as possible.
The company now aims to launch the first product for the human market, Paclical® and the first product for the veterinary market, Paccal® Vet, in one or more regions in 2012. For the latter, the previous aim was to launch in 2011, but registration has not been obtained in time for that.
One part of Oasmia's business model is to license sales rights to companies which have the right resources for marketing and sales. In addition to already closed license agreements, Oasmia estimates that there are very good conditions for further licensing for interesting regions.
The company has set a goal that the debt/equity ratio shall not exceed 50 %. At the end of the fiscal year (July 31), the debt/equity ratio was 0%.
BUSINESS ACTIVITIES
Oasmia develops a new generation of pharmaceuticals within human and veterinary oncology. The product development aims to manufacture novel formulations of well-established cytostatics which, compared to current alternatives, have improved properties, a reduced side-effect profile, and a wider therapeutic spectrum. The product development is based on in-house research within nanotechnology and company patents. The company's most essential patents are global and expire in 2023. Further patent applications have been submitted to protect Oasmia's technology and new formulations which could extend the patent protection to the year 2028. Oasmia has now started to receive such approvals.
One part of Oasmia's business model is taking responsibility for the supply chain – from product idea to final product and licensing of sales rights, to companies who have the right resources for marketing and sales.
The product candidates undergo clinical trials controlled by Oasmia personnel who commit clinics and contract research organizations (CRO). Thereafter, an application for registration of the product for sales on the market follows. In such an application, the product and its manufacturing process are included.
Oasmia's in-house production facility is used for production of pharmaceuticals for clinical trials. It may also be used for small scale commercial production of pharmaceuticals. The application submitted in the USA and the EU
for registration of Paccal® Vet is based on manufacturing of the product in the facility in Uppsala. To provide the market with larger volumes in the future, Oasmia has closed an agreement with a contract manufacturer, Baxter Oncology, who has a much greater production capacity compared to the in-house facility. This kind of change in manufacturing unit requires a specific approval from pharmaceutical authorities.
For upcoming products, such as Paclical®, the intention is to apply for approval with a contract manufacturer as producer of the pharmaceutical from the beginning.
Final labelling, packing and distribution will be made from the in-house facility in Uppsala in order to ensure that all markets are continuously supplied with products.
FINANCAL INFORMATION
Consolidated Income Statement in brief
| 2011 | 2010 | 2010/11 | |
|---|---|---|---|
| TSEK | May-July | May-July | May-April |
| Net sales | 891 | 42 | 106 |
| Capitalized development cost | 20 084 | 20 017 | 86 049 |
| Operating income | -15 368 | -11 216 | -64 353 |
| Net income after tax | -15 260 | -12 090 | -65 960 |
| Earnings per share (SEK), before and after dilution* | -0,29 | -0,31 | -1,50 |
| Comprehensive income for the period | -15 260 | -12 090 | -65 960 |
* Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2010/2011.
Net sales
Net sales for the fiscal year amounted to TSEK 891 (42) and consisted of license revenue in connection to closing an agreement with Medison Pharma.
Capitalized development cost
Capitalized development cost consists of the company's investments in clinical Phase III trials. They amounted to TSEK 20 084 (20 017) for the period and concerned Paclical® only.
Capitalization of Paccal® Vet was concluded at the end of the last fiscal year, since an application of registration of Paccal® Vet was submitted in August 2010 and any development work contributing further economic value to the product candidate is no longer performed.
Operating expenses
The total operating expenses excluding depreciation and impairment amounted to TSEK 35 123 (30 238). The increase in expenses is attributable to an increased intensity in the Phase III study for Paclical®. Of these operating expenses, 57 % (66) were capitalized as Capitalized development cost. The share of capitalized operating expenses has decreased successively since Paccal® Vet was submitted for registration. The number of employees was 70 (69) at the end of the quarter.
Income for the period
Net income for the quarter was TSEK -15 260 (-12 090). The increase in loss is attributable to the reduction in capitalized development cost.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Financial position
The consolidated liquid assets at the end of the quarter amounted to TSEK 20 112 (107). Equity at the same time amounted to TSEK 278 911 (129 713). At the end of the quarter, the equity/assets ratio was 91 % (67) and the debt/equity ratio 0 % (32). The company has unutilized credits amounting to TSEK 45 000 and an unutilized SEDA-agreement (standby equity distribution agreement) amounting to TSEK 75 000.
Cash flow and Capital expenditures
Cash flow from operating activities in the quarter amounted to TSEK -10 940 (-9 076). The change compared to the previous year consisted of increased operational expenditures.
Capital expenditures amounted to TSEK 21 735 (22 884) where investments in intangible assets amounted to TSEK 20 239 (20 017) and investments in property, plant and equipment amounted to TSEK 1 496 (2 868). Investments in intangible assets consisted of capitalized development costs TSEK 20 084 and patents TSEK 155. Investments in property, plant and equipment mainly concerned production equipment. Starting in the past quarter, Oasmia also invests in production equipment in Baxter Oncology in addition to Uppsala.
Financing in the quarter was performed by use of liquid assets.
The parent company
The parent company net sales in the quarter amounted to TSEK 891 (42) and net income after tax amounted to TSEK -15 196 (-12 113). The parent company liquid assets at the end of the period amounted to TSEK 20 096 (32).
Key ratios and other information
| 2011 | 2010 | 2010/11 | |
|---|---|---|---|
| May-July | May-July | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* |
52 079 | 38 403 | 52 079 |
| Average number of shares (in thousands) before and after dilution* | 52 079 | 38 403 | 44 061 |
| Earnings per share in SEK, before and after dilution* | -0,29 | -0,31 | -1,50 |
| Equity per share, SEK* | 5,36 | 3,38 | 5,65 |
| Equity/Assets ratio, % | 91 | 67 | 92 |
| Net liability, TSEK | -20 112 | 41 428 | -51 895 |
| Debt/Equity ratio, % | - | 32 | - |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 70 | 69 | 68 |
* Recalculation of historical values has been made with respect to capitalization issue elements in the preferential rights share issue carried out in the second quarter 2009/10 and third quarter 2010/11.
Definitions
Earnings per share, before and after dilution: The income for the period attributable to the equity holders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity in comparison with the number of shares at the end of the period
Equity/assets ratio: Equity pertaining to the balance sheet total.
Net liability: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deductions for liquid funds
Debt/Equity ratio: Net liability with respect to equity.
Return on total equity: Income for interest expenses pertaining to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Net sales | 891 | 42 | 106 | |
| Capitalized development cost | 20 084 | 20 017 | 86 049 | |
| Other operating income | 42 | 27 | 269 | |
| Raw materials, consumables and goods for resale | -3 652 | -2 662 | -16 120 | |
| Other external expenses | -21 442 | -18 133 | -92 479 | |
| Employee benefit expenses | -10 028 | -9 443 | -37 370 | |
| Depreciation/amortization and impairment | -1 262 | -1 064 | -4 674 | |
| Other operating expenses | - | - | -133 | |
| Operating income | -15 368 | -11 216 | -64 353 | |
| Financial income | 132 | 19 | 484 | |
| Financial expenses | -24 | -893 | -2 097 | |
| Financial items, net | 107 | -874 | -1 613 | |
| Income before taxes | -15 260 | -12 090 | -65 967 | |
| Taxes | 2 | - | 0 | 7 |
| Income for the period | -15 260 | -12 090 | -65 960 | |
| Income for the period attributable to: | ||||
| Equity holders of the Parent company | -15 260 | -12 089 | -65 960 | |
| Non-controlling interest | - | -1 | - | |
| Earnings per share | ||||
| Before dilution, SEK | -0,29 | -0,31 | -1,50 | |
| After dilution, SEK | -0,29 | -0,31 | -1,50 |
Consolidated Statement of Comprehensive income
| 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Income for the period | -15 260 | -12 090 | -65 960 | |
| Comprehensive income for the period | -15 260 | -12 090 | -65 960 | |
| Comprehensive income for the period attributable to: |
||||
| Equity holders of the Parent company | -15 260 | -12 089 | -65 960 | |
| Non-controlling interest | - | -1 | - | |
| Comprehensive Earnings per share | ||||
| Before dilution, SEK | -0,29 | -0,31 | -1,50 | |
| After dilution, SEK | -0,29 | -0,31 | -1,50 |
Consolidated statement of financial position
Pledged assets 6
| TSEK | Note | 2011-07-31 | 2010-07-31 | 2011-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 27 706 | 22 687 | 27 243 | |
| Capitalized development cost | 3 | 246 993 | 160 877 | 226 909 |
| Other intangible assets | 9 201 | 7 829 | 9 276 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 283 903 | 191 395 | 263 430 | |
| Current assets | ||||
| Inventories | - | 94 | - | |
| Trade receivables | 1 289 | 1 326 | 2 141 | |
| Prepaid expenses and accrued income | 2 448 | 1 211 | 2 853 | |
| Liquid assets | 20 112 | 107 | 51 895 | |
| Total Current assets | 23 849 | 2 737 | 56 889 | |
| TOTAL ASSETS | 307 751 | 194 132 | 320 319 | |
| EQUITY | ||||
| Equity attributed to equity holders in the Parent Company | ||||
| Share capital | 5 208 | 3 761 | 5 208 | |
| Other capital provided | 413 375 | 196 493 | 413 375 | |
| Retained earnings | -139 672 | -70 597 | -124 411 | |
| Total | 278 911 | 129 657 | 294 171 | |
| Non-controlling interest | - | 56 | - | |
| Total equity | 278 911 | 129 713 | 294 171 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 4 | 16 264 | 15 397 | 15 373 |
| Deferred tax liabilities | - | 7 | - | |
| Total Non-current liabilities | 16 264 | 15 404 | 15 373 | |
| Current liabilities | ||||
| Liabilities to credit institutions | - | 4 985 | - | |
| Short-term borrowings | 5 | - | 36 550 | - |
| Trade payables | 5 044 | 612 | 3 831 | |
| Other current liabilities | 1 325 | 1 449 | 1 399 | |
| Accrued expenses and prepaid income | 6 207 | 5 419 | 5 545 | |
| Total Current liabilities | 12 576 | 49 015 | 10 775 | |
| Total Liabilities | 28 841 | 64 419 | 26 148 | |
| TOTAL EQUITY AND LIABILITIES | 307 751 | 194 132 | 320 319 | |
| Contingent liabilities | 6 |
Consolidated statement of changes in equity
| Attributable to equity holders in Parent company | |||||
|---|---|---|---|---|---|
| Other | Non | ||||
| paid-up | Retained | controlling | |||
| TSEK | Share capital | capital | earnings | interest | Total equity |
| Opening balance as of May 1 2010 | 3 761 | 196 493 | -58 509 | 57 | 141 803 |
| Comprehensive income for the period | - | - | -12 089 | -1 | -12 090 |
| Closing balance as of July 31, 2010 | 3 761 | 196 493 | -70 597 | 56 | 129 713 |
| Opening balance as of May 1, 2010 | 3 761 | 196 493 | -58 509 | 57 | 141 803 |
| Comprehensive income for the period | - | - | -65 960 | - | -65 960 |
| Acquired non-controlling interest | - | - | 57 | -57 | 0 |
| New share issue | 1 447 | 237 250 | - | - | 238 697 |
| Issue expenses | - | -20 369 | - | - | -20 369 |
| Closing balance as of April 30, 2011 | 5 208 | 413 375 | -124 411 | 0 | 294 171 |
| Opening balance as of May 1, 2011 | 5 208 | 413 375 | -124 411 | 0 | 294 171 |
| Comprehensive income for the period | - | - | -15 260 | - | -15 260 |
| Closing balance as of July 31, 2011 | 5 208 | 413 375 | -139 672 | 0 | 278 911 |
Consolidated Cash flow statement
| 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Operating activities | ||||
| Operating income before financial items | -15 368 | -11 216 | -64 353 | |
| Depreciation/amortization | 1 262 | 1 064 | 4 650 | |
| Impairment of inventory | - | - | 94 | |
| Disposals of intangible assets | - | - | 133 | |
| Interest received | 132 | 19 | 484 | |
| Interest paid | -24 | -893 | -1 392 | |
| Cash flow from operating activities before work | ||||
| ing capital changes | -13 998 | -11 026 | -60 385 | |
| Change in working capital | ||||
| Change in trade receivables | - | 60 | 60 | |
| Change in other current receivables | 1 257 | 2 013 | -445 | |
| Change in trade payables | 1 213 | -1 463 | 1 756 | |
| Change in other current liabilities | 589 | 1 339 | 1 415 | |
| Cash flow from operating activities | -10 940 | -9 076 | -57 598 | |
| Investing activities | ||||
| Investments in intangible fixed assets | -20 239 | -20 017 | -88 342 | |
| Investments in property, plant and equipment | -1 496 | -2 868 | -10 321 | |
| Cash flow from investing activities | -21 735 | -22 884 | -98 663 | |
| Financing activities | ||||
| Increase in liabilities to credit institutions | - | 696 | - | |
| Decrease in liabilities to credit institutions | - | - | -4 289 | |
| Increase in long-term liabilities | 4 | 891 | - | - |
| New share issue | - | - | 168 697 | |
| Issue expenses | - | - | -20 369 | |
| New loans | - | 26 000 | 58 745 | |
| Cash flow from financing activities | 891 | 26 696 | 202 784 | |
| Cash flow for the period | -31 784 | -5 265 | 46 523 | |
| Cash and cash equivalents at the beginning of | ||||
| the period | 51 895 | 5 372 | 5 372 | |
| Cash and cash equivalents at the end of the | ||||
| period | 20 112 | 107 | 51 895 |
Parent Company Income statement
| 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Net sales | 891 | 42 | 106 | |
| Capitalized development cost | 20 084 | 20 017 | 86 049 | |
| Other operating income | 42 | 27 | 245 | |
| Raw materials, consumables and goods for resale | -3 652 | -2 633 | -16 080 | |
| Other external expenses | -21 406 | -18 081 | -92 271 | |
| Employee benefit expenses | -10 028 | -9 443 | -37 370 | |
| Depreciation/amortization and impairment of property, plant, equipment and intangible assets |
-1 234 | -1 018 | -4 486 | |
| Operating income | -15 303 | -11 089 | -63 806 | |
| Result from participations in Group companies | - | -150 | -578 | |
| Other interest revenues and similar revenues | 131 | 19 | 483 | |
| Interest cost and similar costs | -24 | -893 | -2 097 | |
| Financial items, net | 107 | -1 024 | -2 192 | |
| Income after financial items | -15 196 | -12 113 | -65 998 | |
| Taxes | 2 | - | - | - |
| Income for the period | -15 196 | -12 113 | -65 998 |
Parent Company Balance Sheet
| TSEK | Note | 2011-07-31 | 2010-07-31 | 2011-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost | 3 | 246 993 | 160 877 | 226 909 |
| Concessions, patents, licenses, trademarks and similar rights |
9 134 | 7 458 | 9 180 | |
| Property, plant and equipment | ||||
| Equipment, tools, fixtures and fittings | 26 352 | 22 687 | 27 243 | |
| Advance payments for property, plant and equipment Financial assets |
1 355 | - | - | |
| Participations in group companies | 110 | 298 | 110 | |
| Receivables from group companies | 5 | 4 | 5 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 283 949 | 191 324 | 263 448 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | - | 94 | - | |
| Current receivables | 0 | 94 | 0 | |
| Receivables from group companies | 5 | 102 | 220 | 89 |
| Other current receivables | 1 288 | 1 318 | 2 140 | |
| Prepaid expenses and accrued income | 2 385 | 1 131 | 2 748 | |
| 3 775 | 2 669 | 4 977 | ||
| Cash and bank balances | 20 096 | 32 | 51 884 | |
| Total current assets | 23 870 | 2 794 | 56 861 | |
| TOTAL ASSETS | 307 820 | 194 118 | 320 309 | |
| EQUITY AND LIABILITIES Equity Restricted equity |
||||
| Share capital | 5 208 | 3 761 | 5 208 | |
| Statutory reserve | 4 620 | 4 620 | 4 620 | |
| 9 828 | 8 381 | 9 828 | ||
| Non-restricted equity | ||||
| Share premium reserve | 413 375 | 196 493 | 413 375 | |
| Retained earnings | -129 028 | -63 030 | -63 030 | |
| Income for the period | -15 196 | -12 113 | -65 998 | |
| 269 151 | 121 351 | 284 347 | ||
| Total equity | 278 979 | 129 732 | 294 175 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 4 | 16 264 | 15 373 | 15 373 |
| Total non-current liabilities | 16 264 | 15 373 | 15 373 | |
| Current liabilities | ||||
| Short term borrowings | 5 | - | 36 550 | - |
| Trade payables | 5 044 | 611 | 3 818 | |
| Liabilities to Credit institutions | - | 4 985 | - | |
| Other current liabilities | 1 325 | 1 449 | 1 399 | |
| Accrued expenses and prepaid income | 6 207 | 5 419 | 5 545 | |
| Total Current liabilities | 12 576 | 49 013 | 10 761 | |
| TOTAL EQUITY AND LIABILITIES | 307 820 | 194 118 | 320 309 | |
| Contingent liabilities and pledged assets | ||||
| Contingent liabilities | 6 | - | - | - |
| Pledged assets | 6 | 8 000 | 5 000 | 8 000 |
Parent Company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| Statutory | Non-restricted | |||
| TSEK | Share capital | reserve | equity | Total equity |
| Opening balance as of May 1, 2010 | 3 761 | 4 620 | 133 464 | 141 845 |
| Income for the period | - | - | -12 113 | -12 113 |
| Closing balance as of July 31, 2010 | 3 761 | 4 620 | 121 351 | 129 732 |
| Opening balance as of May 1, 2010 | 3 761 | 4 620 | 133 464 | 141 845 |
| New share issue | 1 447 | - | 237 250 | 238 697 |
| Issue expenses | - | - | -20 369 | -20 369 |
| Income for the period | - | - | -65 998 | -65 998 |
| Closing balance as of April 30, 2011 | 5 208 | 4 620 | 284 347 | 294 175 |
| Opening balance as of May 1, 2011 | 5 208 | 4 620 | 284 347 | 294 175 |
| Income for the period | - | - | -15 196 | -15 196 |
| Closing balance as of July 31, 2011 | 5 208 | 4 620 | 269 151 | 278 979 |
Note 1 Accounting policies
This interim report is established in accordance with IAS 34, Interim Reporting and the Securities market Act. The consolidated accounts have been established in accordance with the International Financial Reporting Standards (IFRS) such as they have been adopted by the EU and interpretations by the International Financial Reporting Interpretation Committee (IFRIC) RFR 1, Complementary accounting regulations for Groups and the Annual Accounts Act. The Parent Company accounts are established in accordance with RFR 2, Accounting for legal entities and the Annual Accounts Act. The Group and Parent company accounting policies and calculation methods are unchanged compared to the ones described in the Annual Report for the fiscal year May 1 2010 – April 30 2011. The new and revised accounting policies applied by Oasma since May 1, 2011, has not had any effect on Oasmia's financial reports.
Note 2 Taxes
The Group has accumulated losses carried forward amounting to TSEK 178 054 (109 061) and the Parent Company has similar amounting to TSEK 168 791 (100 276). Of the total losses carried forward for the Group, TSEK 17 881 (17 881) are restricted for use through group contributions. This limitation will end by the 2014 tax assessment. The future tax effect of these losses carried forward has not been marked with a value and no deferred tax asset has been considered in the Balance Sheet.
Note 3 Capitalized development cost
| TSEK | 2011-07-31 | 2010-07-31 | 2011-04-30 |
|---|---|---|---|
| Paclical® | 165 942 | 91 409 | 145 858 |
| Paccal® Vet | 81 051 | 69 468 | 81 051 |
| Summa | 246 993 | 160 877 | 226 909 |
Note 4 Other long-term liabilities
Other long-term liabilities amounting to TSEK16 264 (15 371) consist of prepaid income from two license and distribution agreements. In May 2011, Oasmia closed an agreement with Medison Pharma. According to the agreement, 0.1 MEUR, corresponding to TSEK 891, of the 0.2 MEUR received in a first milestone payment, will be repaid if Oasmia has not obtained a market approval for Paclical® in the EU before the end of 2015. TSEK 15 373 consists of prepaid income attributable to the license and distribution agreement closed with Abbott Laboratories in July 2009. According to the agreement, 2 MUSD of the 5 MUSD received in a first milestone payment in 2009, will be repaid if Oasmia has not obtained market approval for Paccal® Vet before May 1, 2014. The company evaluates every license and distribution agreement separately with regards to accounting and revenues and prepaid income. Especially terms associated with milestone payments, but also other terms within the frame of such an agreement are evaluated.
Note 5 Transactions with related parties
Essential transactions with related parties are disclosed below.
The principal owner Alceco International S.A has provided Oasmia with a credit facility amounting to MSEK 40. The credit facility is valid until August 2011 and is automatically extended with 12 months of the credit is not cancelled by either party 3 months before the term expiration date at the latest. The contract interest amounts to 6 %. As of July 31 2011, the company had no liabilities to Alceco International S.A. (As of July 31 2010, the company used credit facilities amounting to TSEK 36 550 of provided credit from Alceco International S.A.)
Oasmias claim in the subsidiary Qdoxx Pharma AB amounted as of closing day to TSEK 102 (220).
Note 6 Contingent liabilities and Pledged assets
The parent company has made a floating charge of MSEK 8 to a bank as security for a MSEK 5 bank overdraft and limit for a MSEK 3 exchange derivative.
Note 7 Risk factors
The Group is subjected to a number of different risks through its business. By creating awareness of the risks involved in the activities these risks can be limited, controlled and managed and at the same time as business opportunities can be utilized to increase earnings. The risks to Oasmia's business activities are described in the Annual report for the fiscal year May 1 2010 – April 30 2011. No additional risks beyond those described therein have been judged significant.
The Board of Directors and CEO of Oasmia Pharmaceutical AB ensures that this Interim report gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group faces.
Uppsala, September 8, 2011
Bjƒrn Bjƒrnsson, Chairman Claes Piehl,Member
Peter Strƒm,Member Bo Cederstrand, Member
Julian Aleksov,Member and Chief Executive Officer
The information in this Interim report is such that Oasmia Pharmaceutical (publ) must publish according to the code of tradein financial instruments. The information was d elivered for publication on September 8 , 2011 at 09.00.
This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.
This Interim report has not been reviewed by the company auditors.
COMPANY INFORMATION Oasmia Pharmaceutical AB (publ) VAT-number: SE556332-667601 Seat:Stockholm
Address and telephone number to the Main Office Vallongatan 1 75228 UPPSALA, SWEDEN +46 18 50 54 40 www.oasmia.com [email protected]
Questions concerning the report are answered by: Weine Nejdemo, CFO +46 18 50 54 40
UPCOMING REPORT DATES
| Interim report May – October 2011 | 2011-12-08 |
|---|---|
| Interim report May 2010 – January 2012 | 2012-03-08 |
| Year-end report May 2011 - April 2012 | 2012-06-14 |
| Annual report May 2011 – April 2012 | 2012-08-23 |
| Interim report May – July 2012 | 2012-09-06 |