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Vivesto — Interim / Quarterly Report 2013
Jun 7, 2013
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Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Year-end report for the fiscal year May 2012 - April 2013 €
Page 1-10 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 ten pages of that report converted to EUR. The full official report will be found on pages 11-24. 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 per April 30, 2013 which was 8.5753 SEK per one EUR. Some figures are in SEK because these are very firmly denominated in SEK.
CONTINUED EXPANSION OF THE PRODUCT CANDIDATE PORTFOLIO AND STRATEGIC AGREEMENTS IN THE FISCAL YEAR
FOURTH QUARTER February 1 – April 30, 2013
- Consolidated Net sales amounted to € 0 thousand (0)1
- Operating income amounted to € -2,556 thousand (-2,265)
- Net income after tax amounted to € -2,677 thousand (-2,302)
- Earnings per share amounted to € -0.03 (-0.04)
- Comprehensive income amounted to € -2,677 thousand (-2,302)
- Oasmia and Pharmasyntez entered into a distribution agreement for Paclical® in Russia and CIS
THE FISCAL YEAR May 1, 2012 – April 30, 2013
- Consolidated Net sales amounted to € 0 thousand (104)
- Operating income amounted to € -7,881 thousand (-7,642)
- Net income after tax amounted to € -8,441 thousand (-7,658)
- Earnings per share amounted to € -0.12 (-0.14)
- Comprehensive income amounted to € -8,441 thousand (- 7,658)
EVENTS AFTER CLOSING DAY
- Oasmia has developed the first pharmaceutical with two active cytostatics in one infusion, based on its patent protected XR-17 technology.
- Oasmia has initiated a clinical program for treatment of breast cancer with Paclical®
The numbers in parentheses concern results from the corresponding period of the previous year
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
CEO COMMENTS ON THE FISCAL YEAR:
"In the last year, we have advanced our positions regarding our product candidate portfolio and by signing strategic agreements with partners for future launches. We now have a stable foundation which, in line with our business strategy, creates good conditions to build a pharmaceutical company with innovative, patented products on the market", says CEO Julian Aleksov.
HUMAN HEALTH
Paclical®
Paclical® is a patented formulation of the well-known substance paclitaxel which is frequently used within treatment of cancer. Paclical® is designated as an orphan drug (see below) in EU and USA for the indication ovarian cancer.
Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer, an indication with 225 000 annual new cases globally. The total number of patients in the study is 790, and the final patient was treated in the fourth quarter of the fiscal year. All patients are being followed-up regarding time to progression. When the time to progression data has been evaluated, Oasmia will submit a marketing authorization application for Paclical in the EU and in USA, for the treatment of ovarian cancer.
In February 2013, Oasmia and Pharmasyntez, a pharmaceutical company in Russia, entered into a distribution agreement for Paclical in Russia and the CIS. Net sales of current products in the Russian market segment comprising Paclical, is estimated to amount to more than \$600 million and growing steadily. Pharmasyntez was founded in 1997 and is now one of the ten largest pharmaceutical companies in Russia. Pharmasyntez collaborates with a number of leading institutes and universities in Russia.
In September 2012, Oasmia submitted an application of market authorization for Paclical in Russia; which is currently being processed by the pharmaceutical authorities in the country.
In September 2012, Oasmia initiated a collaboration concerning joint product development with Pharmasyntez in Russia.
Doxophos®
Doxophos® is a patented formulation of doxorubicin, one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation for this product candidate, in order to take it into a clinical program.
Docecal®
Docecal® is a patented formulation of the well-known substance docetaxel. Oasmia has initiated the validation process for manufacture of Docecal and are preparing a clinical program for the product candidate.
Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (USA) years on the indication, when the drug is approved for market.
ANIMAL HEALTH
Product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs. Oasmia is focusing on the two most common indications, mastocytoma and lymphoma, which comprise about
half of all cancer in dogs. Product development has made it possible to expand the range to encompass in addition the indications mammary carcinoma and squamous cell carcinoma.
In January 2013, Oasmia and Abbott expanded their collaboration to encompass a large portion of the world and to include both product candidates Paccal® Vet and Doxophos® Vet. The geographic exceptions from the agreement with Abbott are Russia and the CIS, and furthermore Paccal® Vet for Japan which is licensed to Nippon Zenyaku Kogyo.
Paccal® Vet
Paccal® Vet is a patented formulation of the well-known substance paclitaxel.
Oasmia has submitted an application of market authorization of Paccal® Vet for treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma to the FDA. The process is proceeding in a positive way.
All three indications have previously been granted MUMS designation (see below) by the FDA.
After consultation with EMA, Oasmia initiated a new study comprising 50 dogs, which is currently enrolling patents. One parameter in the study is time to progression. As soon as these data have been collected and processed, a new application for market approval for Paccal Vet will be submitted to EMA.
Doxophos® Vet
Doxophos® Vet is a patented formulation of doxorubicin, which Oasmia is developing for treatment of lymphoma (lymph node cancer), which is the most common cancer indication in dogs. Oasmia is currently conducting a Phase I study for Doxophos® Vet which will comprise around 15 dogs.
In July 2012, Doxophos® Vet was granted MUMS designation by the FDA for the indication lymphoma.
MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
Nexttobe AB increases its ownership in Oasmia
In January 2013, Nexttobe AB, the second largest owner in the company, increased its stake in Oasmia from 17.4 % to 21.6 % of the total number of shares and votes in Oasmia. The shares were acquired from the largest owner Alceco International S.A who thereby decreased its stake from 46.9 % to 42.7 %.
Preferential rights share issue completed
In November 2012, Oasmia completed a preferential share issue comprising MSEK 123 before issue expenses and MSEK 118 after such expenses. The issue price was SEK 5 per share. The share issue was fully underwritten by subscription and guarantee commitments from Oasmia's two principal owners, Alceco International S.A. and Nexttobe AB. The share issue had the consequence that Alceco International S.A. increased its ownership from 46.8 % to 46.9 % and Nexttobe AB from 10.1 % to 17.4 %.
Nexttobe AB increases its commitment in Oasmia through further financing
In May 2012, Nexttobe AB increased its commitment in Oasmia through an additional loan of MSEK 65, and in October 2012 by another MSEK 15. The total amount lent from Nexttobe to Oasmia is thus MSEK 105.
EVENTS AFTER THE CLOSING DAY
Oasmia has developed the first pharmaceutical with two active cytostatics in one infusion In May 2013 Oasmia announced that a novel unique combination therapy for treatment of cancer has been developed using the patented XR-17 technology. In a combination therapy, which is the standard treatment for
many different cancer diseases, such as breast cancer, prostate cancer and lung cancer, a patient receives several active cytostatics through separate infusions. Oasmia has successfully developed the product candidate OAS-19, a unique combination of two of the most infused cytostatics. The market for combination therapies exceeds \$8 billion.
Oasmia has initiated a clinical program for treatment of breast cancer with Paclical®
The company announced in May 2013 that it intends to expand the future indication area for Paclical and has therefore started a clinical program for the treatment of breast cancer. The market amounted to \$8.6 billion in 2011. The program will comprise three clinical studies: one Dose finding-study, one Phase II-study and one Phase III-study. The two first studies have been started in May 2013. The number of patients in the Phase II-study will be determined by the Dose Limiting Toxicity (DLT) which will be established during the first study.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | - | 104 |
| Capitalized development cost | 1,262 | 1,671 | 5,672 | 7,380 |
| Operating income | -2,556 | -2,265 | -7,881 | -7,642 |
| Net income after tax | -2,677 | -2,302 | -8,441 | -7,658 |
| Earnings per share (€), before and after dilution* | -0.03 | -0.04 | -0.12 | -0.14 |
| Comprehensive income for the period | -2,677 | -2,302 | -8,441 | -7,658 |
*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 2012/13.
FOURTH QUARTER
February 1 – April 30, 2013
Net sales Oasmia had no net sales in the quarter (-).
Capitalized development cost
Capitalized development cost amounted to € 1,262 thousand (1,671) and concerned mainly Paclical®; Paccal® Vet was included with € 237 thousand. The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials in Phase III for Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to € 3,675 thousand (3,793). The decrease compared to the same quarter previous year is attributable to decreased expenses for Paclical® clinical trials.
The number of employees at the end of the quarter was 75 (77).
Income for the quarter Net income was € -2,677 thousand (-2,302). The decrease is attributable to decreased capitalized development costs and increased interest costs.
THE FISCAL YEAR May 1, 2012 – April 30, 2013
Net sales Oasmia had no net sales in the fiscal year (104).
Capitalized development cost
Capitalized development cost amounted to € 5,672 thousand (7,380). The majority concerned mainly Paclical®; with Paccal® Vet also included amounting to € 385 thousand due to the study to complement the EMA filing which is currently being carried out. The decrease in capitalization is due to the near completion of the Paclical® Phase III study for the treatment of ovarian cancer.
Other operating income
Other operating income amounted to € 294 thousand (12) and consisted mainly of a capital gain in connection to closing of a new agreement with Abbott and an insurance compensation.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to € 13,254 thousand (14,548). This is a 9 % decrease compared to the same period previous year and attributable to lower expenses for Paclical® clinical trials. Of these operating expenses about 43 % (51), were accounted for as Capitalized development cost.
Income for the year
Net income was € -8,441 thousand (-7,658). The decrease is attributable to interest expenses and decreased capitalization of development costs.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Cash flow and Capital expenditures Cash flow from operating activities amounted to € -8,109 thousand (-6,115).
Cash flow from investing activities amounted to € -6,973 thousand (-8,873).
Of these, investments in intangible assets amounted to € 6,950 thousand (8,533), consisting of capitalized development costs € 5,672 thousand (7,380) and patents and other intangible assets € 1,279 thousand (1,154). Disposals of intangible assets provided the company with € 494 thousand (-).
The remainder of investments were in property, plant and equipment amounting to € 516 thousand (340) which in general concerned acquisition of production equipment placed at Baxter in Germany.
Financing
Financing during the period May to November 2012 was performed by borrowing from Nexttobe AB and to a lesser extent utilization of a bank credit. The borrowing from Nexttobe has increased in the fiscal year from € 2,915 thousand to € 12,244 thousand. In October 2012, the entire amount of € 12,244 thousand was rewritten as one loan due for payment on December 31, 2013. The interest rate is still 5 % and will be paid in its entirety when due.
Financing in the period starting November 2012 to the end of April 2013 was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012. When the issue payment was received a utilized bank credit of € 542 thousand was repaid to reduce interest expense.
Financial position
The consolidated liquid assets at the end of the fiscal year amounted to € 7,342 thousand (236). The interestbearing liabilities were € 12,244 thousand (3,825).
At the end of the period, unutilized credits with bank and the principal owner Alceco International S.A amounted to € 583 thousand (210) and € 4,665 thousand (2,379) respectively.
Furthermore, Oasmia holds a SEDA agreement (Standby Equity Distribution Agreement) amounting to € 8,746 thousand, which was completely unutilized on April 30. This agreement ends on July 21, 2013.
Equity at the end of the period amounted to € 37,218 thousand (31,891), the equity/assets ratio was 72 % (78 %) and the net debt/equity ratio was 13 % (11 %).
The parent company
The parent company´s net sales amounted to € 0 thousand (104) and net income before tax amounted to € -8,443 thousand (-7,676). The parent company's liquid assets at the end of the fiscal year amounted to € 7,341 thousand (236).
Key ratios and other information
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| Feb-April | Feb-April | May-April | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* | 81,772 | 58,214 | 81,772 | 58,214 |
| Weighted average number of shares (in thousands) before and after dilution* | 81,772 | 58,214 | 68,605 | 55,589 |
| Earnings per share in €, before and after dilution* | -0.03 | -0.04 | -0.12 | -0.14 |
| Equity per share, €* | 0.46 | 0.55 | 0.46 | 0.55 |
| Equity/Assets ratio, % | 72 | 78 | 72 | 78 |
| Net debt, € thousand | 4,903 | 3,588 | 4,903 | 3,588 |
| Net debt/Equity ratio, % | 13 | 11 | 13 | 11 |
| Return on total assets, % | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg |
| Number of employees at the end of the period | 75 | 77 | 75 | 77 |
*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 2012/13.
Definitions
Earnings per share: The income for the period attributable to the shareholders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity divided by the number of shares at the end of the period
Equity/assets ratio: Equity as a percentage of the balance sheet total.
Net debt: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deduction for liquid funds
Net debt/Equity ratio: Net debt in relation to equity.
Return on total assets: Income before deduction of interest expenses in relation to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | - | 104 |
| Capitalized development cost | 1,262 | 1,671 | 5,672 | 7,380 |
| Other operating income | 4 | 5 | 294 | 12 |
| Raw materials, consumables and goods for resale | -147 | -266 | -716 | -1,181 |
| Other external expenses | -2,190 | -2,202 | -7,583 | -8,569 |
| Employee benefit expenses | -1,328 | -1,324 | -4,945 | -4,798 |
| Depreciation/amortization and impairment | -148 | -148 | -594 | -590 |
| Other operating cost | -10 | - | -10 | - |
| Operating income | -2,556 | -2,265 | -7,881 | -7,642 |
| Financial income | 32 | 3 | 68 | 42 |
| Financial expenses | -153 | -40 | -628 | -58 |
| Financial items, net | -121 | -37 | -559 | -16 |
| Income before taxes | -2,677 | -2,302 | -8,441 | -7,658 |
| Taxes | - | - | - | - |
| Income for the period | -2,677 | -2,302 | -8,441 | -7,658 |
| Income for the period attributable to: | ||||
| Shareholders of the Parent company | -2,677 | -2,302 | -8,441 | -7,658 |
| Earnings per share, before and after dilution, € | -0.03 | -0.04 | -0.12 | -0.14 |
Consolidated Statement of comprehensive income
| € thousands | 2013 Feb-April |
2012 Feb-April |
2012/13 May-April |
2011/12 May-April |
|---|---|---|---|---|
| Income for the period | -2,677 | -2,302 | -8,441 | -7,658 |
| Comprehensive income for the period | -2,677 | -2,302 | -8,441 | -7,658 |
| Comprehensive income for the period attributable to: Shareholders of the Parent company |
-2,677 | -2,302 | -8,441 | -7,658 |
| Comprehensive Earnings per share, before and after dilution, € | -0.03 | -0.04 | -0.12 | -0.14 |
Consolidated statement of financial position
| € thousands | 2013-04-30 | 2012-04-30 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Property, plant and equipment | 3,051 | 3,031 |
| Capitalized development cost | 39,512 | 33,840 |
| Other intangible assets | 1,200 | 3,195 |
| Financial assets | 0 | 0 |
| Total Non-current assets | 43,763 | 40,066 |
| Current assets | ||
| Inventories | 103 | 34 |
| Other current receivables | 270 | 204 |
| Prepaid expenses and accrued income | 436 | 252 |
| Liquid assets | 7,342 | 236 |
| Total Current assets | 8,151 | 726 |
| TOTAL ASSETS | 51,914 | 40,792 |
| EQUITY | ||
| Capital and provisions attributable to shareholders of the Parent Company | ||
| Share capital | 954 | 668 |
| Other capital provided | 66,871 | 53,390 |
| Retained earnings | -30,607 | -22,166 |
| Total Equity | 37,218 | 31,891 |
| LIABILITIES | ||
| Non-current liabilities | ||
| Other non-current liabilities | 104 | 1,897 |
| Total non-current liabilities | 104 | 1,897 |
| Current liabilities | ||
| Liabilities to credit institutions | - | 373 |
| Short-term borrowings | 12,244 | 3,452 |
| Trade payables | 826 | 1,199 |
| Other current liabilities | 183 | 1,261 |
| Accrued expenses and prepaid income | 1,339 | 721 |
| Total Current liabilities | 14,592 | 7,005 |
| Total liabilities | 14,696 | 8,902 |
| TOTAL EQUITY AND LIABILITIES | 51,914 | 40,792 |
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | |||||
|---|---|---|---|---|---|
| Other | |||||
| € thousands | Share capital | capital provided | Retained earnings | Total equity | |
| Opening balance as of May 1, 2011 | 607 | 48,205 | -14,508 | 34,304 | |
| Comprehensive income for the year | - | - | -7,658 | -7,658 | |
| New share issue | 60 | 5,537 | - | 5,597 | |
| Issue expenses | - | -353 | - | -353 | |
| Closing balance as of April 30, 2012 | 668 | 53,390 | -22,166 | 31,891 | |
| Opening balance as of May 1, 2012 | 668 | 53,390 | -22,166 | 31,891 | |
| Comprehensive income for the year | - | - | -8,441 | -8,441 | |
| New share issue | 286 | 14,018 | - | 14,304 | |
| Issue expenses | - | -536 | - | -536 | |
| Closing balance as of April 30, 2013 | 954 | 66,871 | -30,607 | 37,218 |
Consolidated Cash flow statement
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Operating activities | ||||
| Operating income before financial items | -2,556 | -2,265 | -7,881 | -7,642 |
| Depreciation/amortization | 148 | 148 | 594 | 590 |
| Disposals of tangible assets | 10 | - | 10 | - |
| Adjustments for income from divestiture of intangible assets | 0 | - | -184 | - |
| Interest received | 32 | 3 | 68 | 42 |
| Interest paid | -3 | -40 | -71 | -58 |
| Cash flow from operating activities before working capital changes | -2,370 | -2,153 | -7,464 | -7,068 |
| Change in working capital | ||||
| Change in inventories | - | - | -70 | -34 |
| Change in other current receivables | -189 | -23 | -250 | 127 |
| Change in trade payables | 309 | 554 | -373 | 752 |
| Change in other current liabilities | 99 | 132 | 48 | 108 |
| Cash flow from operating activities | -2,150 | -1,491 | -8,109 | -6,115 |
| Investing activities | ||||
| Investments in intangible fixed assets | -1,262 | -2,555 | -6,950 | -8,533 |
| Divestiture of intangible fixed assets | - | - | 494 | - |
| Investments in property, plant and equipment | -9 | -118 | -516 | -340 |
| Cash flow from investing activities | -1,272 | -2,672 | -6,973 | -8,873 |
| Financing activities | ||||
| Increase in liabilities to credit institutions | - | 373 | - | 373 |
| Decrease in liabilities to credit institutions | - | - | -373 | - |
| Increase in long-term liabilities | - | - | - | 104 |
| New share issue | - | - | 14,304 | 5,597 |
| Issue expenses | -4 | - | -536 | -353 |
| New loans | - | 3,452 | 9,329 | 3,452 |
| Repayment of loans | - | - | -536 | - |
| Cash flow from financing activities | -4 | 3,825 | 22,187 | 9,173 |
| Cash flow for the period | -3,426 | -338 | 7,105 | -5,815 |
| Cash and cash equivalents at the beginning of the period | 10,768 | 575 | 236 | 6,052 |
| Cash and cash equivalents at the end of the period | 7,342 | 236 | 7,342 | 236 |
Oasmia Pharmaceutical AB (publ)
Year-end report for the fiscal year May 2012 - April 2013
CONTINUED EXPANSION OF THE PRODUCT CANDIDATE PORTFOLIO AND STRATEGIC AGREEMENTS IN THE FISCAL YEAR
FOURTH QUARTER February 1 – April 30, 2013
- Consolidated Net sales amounted to TSEK 0 (0) 2
- Operating income amounted to TSEK –21 920 (-19 419)
- Net income after tax amounted to TSEK –22 953 (-19 737)
- Earnings per share amounted to SEK 0,28 (-0,34)
- Comprehensive income amounted to TSEK -22 953 (-19 737)
- Oasmia and Pharmasyntez entered into a distribution agreement for Paclical® in Russia and CIS
THE FISCAL YEAR May 1, 2012 – April 30, 2013
- Consolidated Net sales amounted to TSEK 0 (891)
- Operating income amounted to TSEK –67 583 (-65 536)
- Net income after tax amounted to TSEK –72 381 (-65 670)
- Earnings per share amounted to SEK -1,06 (-1,18)
- Comprehensive income amounted to TSEK -72 381 (-65 670)
EVENTS AFTER CLOSING DAY
- Oasmia has developed the first pharmaceutical with two active cytostatics in one infusion, based on its patent protected XR-17 technology.
- Oasmia has initiated a clinical program for treatment of breast cancer with Paclical®
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at the Frankfurt Stock Exchange.
2 The numbers in parentheses concern results from the corresponding period of the previous year
BUSINESS ACTIVITIES
CEO COMMENTS ON THE FISCAL YEAR:
"In the last year, we have advanced our positions regarding our product candidate portfolio and by signing strategic agreements with partners for future launches. We now have a stable foundation which, in line with our business strategy, creates good conditions to build a pharmaceutical company with innovative, patented products on the market", says CEO Julian Aleksov.
HUMAN HEALTH
Paclical®
Paclical® is a patented formulation of the well-known substance paclitaxel which is frequently used within treatment of cancer. Paclical® is designated as an orphan drug (see below) in EU) and USA for the indication ovarian cancer.
Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer, an indication with 225 000 annual new cases globally. The number of patients in the study is 790, and the final patient was treated in the fourth quarter of the fiscal year. All patients are being followed-up regarding time to progression. When the time to progression data has been evaluated, Oasmia will submit a marketing authorization application for Paclical in the EU and in USA, for the treatment of ovarian cancer.
In February 2013, Oasmia and Pharmasyntez, a pharmaceutical company in Russia, entered into a distribution agreement for Paclical in Russia and the CIS. Net sales of current products in the Russian market segment comprising Paclical, is estimated to amount to more than \$600 million and growing steadily. Pharmasyntez was founded in 1997 and is now one of the ten largest pharmaceutical companies in Russia. Pharmasyntez collaborates with a number of leading institutes and universities in Russia.
In September 2012, Oasmia submitted an application of market authorization for Paclical in Russia; which is currently being processed by the pharmaceutical authorities in the country.
In September 2012, Oasmia initiated a collaboration concerning joint product development with Pharmasyntez in Russia.
Doxophos®
Doxophos® is a patented formulation of doxorubicin, one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation for this product candidate, in order to take it into a clinical program.
Docecal®
Docecal® is a patented formulation of the well-known substance docetaxel. Oasmia has initiated the validation process for manufacture of Docecal and are preparing a clinical program for the product candidate.
Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (USA) years on the indication, when the drug is approved for market.
ANIMAL HEALTH
Product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs. The company is focusing on the two most common indications, mastocytoma and lymphoma, which comprise about half of all cancer in dogs. Product development has made it possible to expand the range to encompass in addition the indications mammary carcinoma and squamous cell carcinoma.
In January 2013, Oasmia and Abbott expanded their collaboration to encompass a large portion of the world and to include both product candidates Paccal® Vet and Doxophos® Vet. The geographic exceptions from the agreement with Abbott are Russia and the CIS, and furthermore Paccal® Vet for Japan which is licensed to Nippon Zenyaku Kogyo.
Paccal® Vet
Paccal® Vet is a patented formulation of the well-known substance paclitaxel.
Oasmia has submitted an application of market authorization of Paccal® Vet for treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma to the FDA. The process is proceeding in a positive way.
All three indications have previously been granted MUMS designation (see below) by the FDA.
After consultation with EMA, Oasmia initiated a new study comprising 50 dogs, which is currently enrolling patents. One parameter in the study is time to progression. As soon as these data data have been collected and processed, a new application for market approval for Paccal Vet will be submitted to the EMA.
Doxophos® Vet
Doxophos® Vet is a patented formulation of doxorubicin, which Oasmia is developing for treatment of lymphoma (lymph node cancer), which is the most common cancer indication in dogs. Oasmia is currently conducting a Phase I study for Doxophos® Vet which will comprise around 15 dogs.
In July 2012, Doxophos® Vet was granted MUMS designation by the FDA for the indication lymphoma.
MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
Nexttobe AB increases its ownership in Oasmia
In January 2013, Nexttobe AB, the second largest owner in the company, increased its stake in Oasmia from 17.4 % to 21.6 % of the total number of shares and votes in Oasmia. The shares were acquired from the largest owner Alceco International S.A who thereby decreased its stake from 46.9 % to 42.7 %.
Preferential rights share issue completed
In November 2012, Oasmia completed a preferential share issue comprising MSEK 123 before issue expenses and MSEK 118 after such expenses. The issue price was SEK 5 per share. The share issue was fully underwritten by subscription and guarantee commitments from Oasmia's two principal owners, Alceco International S.A. and Nexttobe AB. The share issue had the consequence that Alceco International S.A. increased its ownership from 46.8 % to 46.9 % and Nexttobe AB from 10.1 % to 17.4 %.
Nexttobe AB increases its commitment in Oasmia through further financing In May 2012, Nexttobe AB increased its commitment in Oasmia through an additional loan of MSEK 65, and in October 2012 by another MSEK 15. The total amount lent from Nexttobe to Oasmia is thus MSEK 105.
EVENTS AFTER THE CLOSING DAY
Oasmia has developed the first pharmaceutical with two active cytostatics in one infusion
In May 2013 Oasmia announced that a novel unique combination therapy for treatment of cancer has been developed using the patented XR-17 technology. In a combination therapy, which is the standard treatment for many different cancer diseases, such as breast cancer, prostate cancer and lung cancer, a patient receives several active cytostatics through separate infusions. Oasmia has successfully developed the product candidate OAS-19, a unique combination of two of the most infused cytostatics. The market for combination therapies exceeds \$8 billion.
Oasmia has initiated a clinical program for treatment of breast cancer with Paclical®
The company announced in May 2013 that it intends to expand the future indication area for Paclical and has therefore started a clinical program for the treatment of breast cancer. The market amounted to \$8.6 billion in 2011. The program will comprise three clinical studies: one Dose finding-study, one Phase II-study and one Phase III-study. The two first studies have been started in May 2013. The number of patients in the Phase II-study will be determined by the Dose Limiting Toxicity (DLT) which will be established during the first study.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| TSEK | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | - | 891 |
| Capitalized development cost | 10 826 | 14 332 | 48 635 | 63 282 |
| Operating income | -21 920 | -19 419 | -67 583 | -65 536 |
| Net income after tax | -22 953 | -19 737 | -72 381 | -65 670 |
| Earnings per share (SEK), before and after dilution* | -0,28 | -0,34 | -1,06 | -1,18 |
| Comprehensive income for the period | -22 953 | -19 737 | -72 381 | -65 670 |
*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 2012/13.
FOURTH QUARTER February 1 – April 30, 2013
Net sales Oasmia had no net sales in the quarter (-).
Capitalized development cost
Capitalized development cost amounted to TSEK 10 826 (14 332) and concerned mainly Paclical®; Paccal® Vet was included with TSEK 2 036. The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials in Phase III for Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to TSEK 31 514 (32 525). The decrease compared to the same quarter previous year is attributable to decreased expenses for Paclical® clinical trials.
The number of employees at the end of the quarter was 75 (77).
Income for the quarter Net income was TSEK -22 953 (-19 737). The decrease is attributable to decreased capitalized development costs and increased interest costs.
THE FISCAL YEAR May 1, 2012 – April 30, 2013
Net sales Oasmia had no net sales in the fiscal year (891).
Capitalized development cost
Capitalized development cost amounted to TSEK 48 635 (63 282). The majority concerned mainly Paclical®; with Paccal® Vet also included amounting to TSEK 3 299 due to the study to complement the EMA filing which is currently being carried out. The decrease in capitalization is due to the near completion of the Paclical® Phase III study for the treatment of ovarian cancer.
Other operating income
Other operating income amounted to TSEK 2 524 (104) and consisted mainly of a capital gain in connection to closing of a new agreement with Abbott and an insurance compensation.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to TSEK 113 654 (124 751). This is a 9 % decrease compared to the same period previous year and attributable to lower expenses for Paclical® clinical trials. Of these operating expenses about 43 % (51), were accounted for as Capitalized development cost.
Income for the year
Net income was TSEK -72 381 (-65 670). The decrease is attributable to interest expenses and decreased capitalization of development costs.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Cash flow and Capital expenditures Cash flow from operating activities amounted to TSEK -69 539 (-52 439).
Cash flow from investing activities amounted to TSEK -59 795 (-76 090).
Of these, investments in intangible assets amounted to TSEK 59 603 (73 176), consisting of capitalized development costs TSEK 48 635 (63 282) and patents and other intangible assets TSEK 10 967 (9 894). Disposals of intangible assets provided the company with TSEK 4 235 (-).
The remainder of investments were in property, plant and equipment amounting to TSEK 4 428 (2 914) which in general concerned acquisition of production equipment placed at Baxter in Germany.
Financing
Financing during the period May to November 2012 was performed by borrowing from Nexttobe AB and to a lesser extent utilization of a bank credit. The borrowing from Nexttobe has increased in the fiscal year from TSEK 25 000 to TSEK 105 000. In October 2012, the entire amount of TSEK 105 000 was rewritten as one loan due for payment on December 31, 2013. The interest rate is still 5 % and will be paid in its entirety when due.
Financing in the period starting November 2012 to the end of April 2013 was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012. When the issue payment was received a utilized bank credit of TSEK 4 651 was repaid in order to reduce interest expense.
Financial position
The consolidated liquid assets at the end of the fiscal year amounted to TSEK 62 956 (2 028). The interestbearing liabilities were TSEK 105 000 (32 797).
At the end of the period, unutilized credits with bank and the principal owner Alceco International S.A amounted to TSEK 5 000 (1 803) and TSEK 40 000 (20 400) respectively.
Furthermore, Oasmia holds a SEDA agreement (Standby Equity Distribution Agreement) amounting to TSEK 75 000, which was completely unutilized on April 30. This agreement ends on July 21, 2013.
Equity at the end of the fiscal year amounted to TSEK 319 153 (273 474), the equity/assets ratio was 72 % (78 %) and the net debt/equity ratio was 13 % (11 %).
The parent company
The parent company´s net sales amounted to TSEK 0 (891) and net income before tax amounted to TSEK -72 404 (-65 823). The parent company's liquid assets at the end of the fiscal year amounted to TSEK 62 947 (2 020).
Key ratios and other information
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| Feb-April | Feb-April | May-April | May-April | |
| Number of shares at the close of the period (in thousands), before and after | ||||
| dilution * | 81 772 | 58 214 | 81 772 | 58 214 |
| Weighted average number of shares (in thousands) before and after dilution* | 81 772 | 58 214 | 68 605 | 55 589 |
| Earnings per share in SEK, before and after dilution* | -0,28 | -0,34 | -1,06 | -1,18 |
| Equity per share, SEK* | 3,90 | 4,70 | 3,90 | 4,70 |
| Equity/Assets ratio, % | 72 | 78 | 72 | 78 |
| Net debt, TSEK | 42 044 | 30 769 | 42 044 | 30 769 |
| Net debt/Equity ratio, % | 13 | 11 | 13 | 11 |
| Return on total assets, % | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg |
| Number of employees at the end of the period | 75 | 77 | 75 | 77 |
*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 2012/13.
Definitions
Earnings per share: The income for the period attributable to the shareholders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity divided by the number of shares at the end of the period
Equity/assets ratio: Equity as a percentage of the balance sheet total.
Net debt: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deduction for liquid funds
Net debt/Equity ratio: Net debt in relation to equity.
Return on total assets: Income before deduction of interest expenses in relation to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2013 | 2012 | 2012/13 | 2011/12 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | - | 891 | |
| Capitalized development cost | 10 826 | 14 332 | 48 635 | 63 282 | |
| Other operating income | 34 | 46 | 2 524 | 104 | |
| Raw materials, consumables and goods for resale | -1 260 | -2 281 | -6 137 | -10 127 | |
| Other external expenses | -18 778 | -18 887 | -65 022 | -73 481 | |
| Employee benefit expenses | -11 389 | -11 357 | -42 408 | -41 144 | |
| Depreciation/amortization and impairment | -1 265 | -1 273 | -5 089 | -5 062 | |
| Other operating expenses | -86 | - | -86 | - | |
| Operating income | -21 920 | -19 419 | -67 583 | -65 536 | |
| Financial income | 274 | 23 | 587 | 363 | |
| Financial expenses | -1 308 | -341 | -5 384 | -497 | |
| Financial items, net | -1 034 | -318 | -4 798 | -135 | |
| Income before taxes | -22 953 | -19 737 | -72 381 | -65 670 | |
| Taxes | 2 | - | - | - | - |
| Income for the period | -22 953 | -19 737 | -72 381 | -65 670 | |
| Income for the period attributable to: | |||||
| Shareholders of the Parent company | -22 953 | -19 737 | -72 381 | -65 670 | |
| Earnings per share before and after dilution, SEK | -0,28 | -0,34 | -1,06 | -1,18 | |
Consolidated Statement of Comprehensive income
| 2013 | 2012 | 2012/13 | 2011/12 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Income for the period | -22 953 | -19 737 | -72 381 | -65 670 | |
| Comprehensive income for the period | -22 953 | -19 737 | -72 381 | -65 670 | |
| Comprehensive income for the period attributable to: | |||||
| Shareholders of the Parent company | -22 953 | -19 737 | -72 381 | -65 670 | |
| Comprehensive Earnings per share before and after dilution, SEK |
-0,28 | -0,34 | -1,06 | -1,18 |
Consolidated statement of financial position
| TSEK | Note | 2013-04-30 | 2012-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 26 161 | 25 988 | |
| Capitalized development cost | 3 | 338 826 | 290 191 |
| Other intangible assets | 10 294 | 27 400 | |
| Financial assets | 2 | 2 | |
| Total Non-current assets | 375 283 | 343 581 | |
| Current assets | |||
| Inventories | 887 | 290 | |
| Other current receivables | 2 314 | 1 747 | |
| Prepaid expenses and accrued income | 3 737 | 2 161 | |
| Liquid assets | 62 956 | 2 028 | |
| Total Current assets | 69 895 | 6 227 | |
| TOTAL ASSETS | 445 178 | 349 807 | |
| EQUITY | |||
| Capital and provisions attributable to shareholders of the Parent Company | |||
| Share capital | 8 177 | 5 724 | |
| Other capital provided | 573 439 | 457 832 | |
| Retained earnings | -262 463 | -190 082 | |
| Total equity | 319 153 | 273 474 | |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 891 | 16 264 | |
| Total Non-current liabilities | 891 | 16 264 | |
| Current liabilities Liabilities to credit institutions |
- | 3 197 | |
| Short-term borrowings | 4 | 105 000 | 29 600 |
| Trade payables | 7 084 | 10 281 | |
| Other current liabilities | 1 566 | 10 811 | |
| Accrued expenses and prepaid income | 4 | 11 484 | 6 180 |
| Total Current liabilities | 125 134 | 60 069 | |
| Total Liabilities | 126 025 | 76 334 | |
| TOTAL EQUITY AND LIABILITIES | 445 178 | 349 807 | |
| Contingent liabilities | 5 | ||
| Pledged assets | 5 |
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | ||||
|---|---|---|---|---|
| TSEK | Share capital | Other capital provided |
Retained earnings |
Total equity |
| Opening balance as of May 1, 2011 | 5 208 | 413 375 | -124 411 | 294 171 |
| Comprehensive income for the year | - | - | -65 670 | -65 670 |
| New share issue | 516 | 47 484 | - | 48 000 |
| Issue expenses | - | -3 027 | - | -3 027 |
| Closing balance as of April 30, 2012 | 5 724 | 457 832 | -190 082 | 273 474 |
| Opening balance as of May 1, 2012 | 5 724 | 457 832 | -190 082 | 273 474 |
| Comprehensive income for the year | - | - | -72 381 | -72 381 |
| New share issue | 2 453 | 120 205 | - | 122 658 |
| Issue expenses | - | -4 598 | - | -4 598 |
| Closing balance as of April 30, 2013 | 8 177 | 573 439 | -262 463 | 319 153 |
Consolidated Cash flow statement
| 2013 | 2012 | 2012/13 | 2011/12 | |
|---|---|---|---|---|
| TSEK | Feb-April | Feb-April | May-April | May-April |
| Operating activities | ||||
| Operating income before financial items | -21 920 | -19 419 | -67 583 | -65 536 |
| Depreciation/amortization | 1 265 | 1 273 | 5 089 | 5 062 |
| Disposals of tangible assets | 86 | - | 86 | - |
| Adjustments for income from divestiture of intangible assets | - | - | -1 579 | - |
| Interest received | 274 | 23 | 587 | 363 |
| Interest paid | -28 | -341 | -611 | -497 |
| Cash flow from operating activities before | ||||
| working capital changes | -20 322 | -18 464 | -64 010 | -60 609 |
| Change in working capital | ||||
| Change in inventories | - | - | -597 | -290 |
| Change in other current receivables | -1 618 | -195 | -2 142 | 1 085 |
| Change in trade payables | 2 652 | 4 748 | -3 197 | 6 450 |
| Change in other current liabilities | 849 | 1 129 | 408 | 924 |
| Cash flow from operating activities | -18 439 | -12 782 | -69 539 | -52 439 |
| Investing activities | ||||
| Investments in intangible fixed assets | -10 826 | -21 906 | -59 603 | -73 176 |
| Divestiture of intangible fixed assets | - | - | 4 235 | - |
| Investments in property, plant and equipment | -80 | -1 011 | -4 428 | -2 914 |
| Cash flow from investing activities | -10 906 | -22 917 | -59 795 | -76 090 |
| Financing activities | ||||
| Increase in liabilities to credit institutions | - | 3 197 | - | 3 197 |
| Decrease in liabilities to credit institutions | - | - | -3 197 | - |
| Increase in long-term liabilities | - | - | - | 891 |
| New share issue | - | - | 122 658 | 48 000 |
| Issue expenses | -37 | - | -4 598 | -3 027 |
| New loans | 4 - |
29 600 | 80 000 | 29 600 |
| Repayment of loans | 4 - |
- | -4 600 | - |
| Cash flow from financing activities | -37 | 32 797 | 190 263 | 78 662 |
| Cash flow for the period | -29 382 | -2 902 | 60 928 | -49 867 |
| Cash and cash equivalents at the beginning of the period | 92 338 | 4 930 | 2 028 | 51 895 |
| Cash and cash equivalents at the end of the period | 62 956 | 2 028 | 62 956 | 2 028 |
Parent Company Income statement
| 2013 | 2012 | 2012/13 | 2011/12 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | - | 891 | |
| Capitalized development cost | 10 826 | 14 332 | 48 635 | 63 282 | |
| Other operating income | 34 | 46 | 2 524 | 104 | |
| Raw materials, consumables and goods for resale | -1 260 | -2 281 | -6 137 | -10 124 | |
| Other external expenses | -18 765 | -18 845 | -64 916 | -73 323 | |
| Employee benefit expenses | -11 389 | -11 357 | -42 408 | -41 144 | |
| Depreciation/amortization and impairment of property, | |||||
| plant, equipment and intangible assets | -1 261 | -1 265 | -5 074 | -4 987 | |
| Other operating expenses | -86 | - | -86 | - | |
| Operating income | -21 902 | -19 370 | -67 461 | -65 300 | |
| Result from participations in Group companies | 4 | -30 | -105 | -145 | -390 |
| Other interest revenues and similar revenues | 274 | 23 | 587 | 362 | |
| Interest cost and similar costs | -1 308 | -340 | -5 384 | -495 | |
| Financial items, net | -1 064 | -422 | -4 942 | -523 | |
| Income after financial items | -22 966 | -19 791 | -72 404 | -65 823 | |
| Taxes | 2 | - | - | - | - |
| Income for the period | -22 966 | -19 791 | -72 404 | -65 823 |
Parent Company Balance Sheet
| TSEK | Note | 2013-04-30 | 2012-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible fixed assets | |||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 338 826 | 290 191 |
| similar rights | 10 288 | 27 378 | |
| Property, plant and equipment Equipment, tools, fixtures and fittings |
20 355 | 24 149 | |
| Construction in progress and advance payments for property, plant and equipment |
5 805 | 1 839 | |
| Financial assets | |||
| Participations in group companies | 110 | 110 | |
| Other securities held as non-current assets | 1 | 1 | |
| Total Non-current assets | 375 386 | 343 668 | |
| Current assets | |||
| Inventories | |||
| Raw materials and consumables | 887 | 290 | |
| 887 | 290 | ||
| Current receivables | |||
| Receivables from group companies | 4 | - | 55 |
| Other current receivables | 2 312 | 1 746 | |
| Prepaid expenses and accrued income | 3 721 | 2 084 | |
| 6 033 | 3 885 | ||
| Cash and bank balances | 62 947 | 2 020 | |
| Total current assets | 69 867 | 6 195 | |
| TOTAL ASSETS | 445 253 | 349 863 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 8 177 | 5 724 | |
| Statutory reserve | 4 620 | 4 620 | |
| 12 797 | 10 344 | ||
| Non-restricted equity | |||
| Share premium reserve | 573 439 | 457 832 | |
| Retained earnings | -194 851 | -129 028 | |
| Income for the period | -72 404 | -65 823 | |
| 306 184 | 262 981 | ||
| Total equity | 318 981 | 273 325 | |
| Non-current liabilities | |||
| Other non-current liabilities | 891 | 16 264 | |
| Total non-current liabilities | 891 | 16 264 | |
| Current liabilities | |||
| Short term borrowings | 4 | 105 000 | 29 600 |
| Trade payables | 7 084 | 10 281 | |
| Liabilities to Credit institutions | - | 3 197 | |
| Liabilities to group companies | 4 | 247 | 205 |
| Other current liabilities | 1 566 | 10 811 | |
| Accrued expenses and prepaid income | 4 | 11 484 | 6 180 |
| Total Current liabilities | 125 381 | 60 274 | |
| TOTAL EQUITY AND LIABILITIES | 445 253 | 349 863 | |
| Contingent liabilities and pledged assets | |||
| Contingent liabilities | 5 | - | - |
| Pledged assets | 5 | 8 000 | 8 000 |
Parent Company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| TSEK | Share capital | Statutory reserve |
Non-restricted equity |
Total equity |
| Opening balance as of May 1, 2011 | 5 208 | 4 620 | 284 347 | 294 175 |
| New share issue | 516 | - | 47 484 | 48 000 |
| Issue expenses | - | - | -3 027 | -3 027 |
| Income for the period | - | - | -65 823 | -65 823 |
| Closing balance as of April 30, 2012 | 5 724 | 4 620 | 262 981 | 273 325 |
| Opening balance as of May 1, 2012 | 5 724 | 4 620 | 262 981 | 273 325 |
| New share issue | 2 453 | - | 120 205 | 122 658 |
| Issue expenses | - | - | -4 598 | -4 598 |
| Income for the period | - | - | -72 404 | -72 404 |
| Closing balance as of April 30, 2013 | 8 177 | 4 620 | 306 184 | 318 981 |
Note 1 Accounting policies
This report is established in accordance with IAS 34, Interim Financial 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 Interpretations 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 2011 – April 30 2012. The new and revised accounting policies applied by Oasmia since May 1, 2012, has not had any effect on Oasmia's financial reports. The Group currently only has one operating segment and does therefore not disclose any segment information.
Note 2 Taxes
The Group has accumulated losses carried forward amounting to TSEK 300 546 (228 336) and the Parent Company has similar amounting to TSEK 290 988 (218 900). 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
Capitalized development cost consists of the company's investments in clinical Phase III trials. The capitalization means that such costs are capitalized as an intangible asset. The accumulated assets per product candidate are disclosed below.
| TSEK | 2013-04-30 | 2012-04-30 |
|---|---|---|
| Paclical® | 254 475 | 209 140 |
| Paccal® Vet | 84 351 | 81 051 |
| Total | 338 826 | 290 191 |
Note 4 Transactions with related parties
As of April 30, 2013 Oasmia had a credit facility of TSEK 40 000 (25 000) provided by the principal owner of the company, Alceco International SA. The interest rate on utilized credits is 5 %. As of April 30, 2013, this credit was completely unutilized (as of April 30, 2012, TSEK 4 600 had been utilized).
The borrowing from Nexttobe AB has increased in the fiscal year from TSEK 25 000 to TSEK 105 000. In October 2012, the entire amount of TSEK 105 000 was rewritten as one loan due for payment on December 31, 2013. The interest rate is 5 % and will be paid in its entirety when due. As of April 30, 2013, the accrued interest cost for the borrowing was TSEK 5 053 (279).
Guarantee provisions in connection with the preferential rights share issue that was made in November 2012 has been paid to Alceco International S.A. with TSEK 668 and to Nexttobe AB with TSEK 629.
Oasmia has made a TSEK 145 (175) group contribution to the subsidiary Qdoxx Pharma AB (previously Oasmia Global Supplies AB) in the fiscal year where TSEK 30 (-) were provided in the fourth quarter. Impairment of shares in Qdoxx amounting to TSEK 145 (175) have been made in the fiscal year corresponding to the group contributions, as the purpose of the group contributions was to cover losses in the subsidiary. No group contribution has been made to the subsidiary Oasmia Animal Health AB in the fiscal year (a group contribution amounting to TSEK 215 with a corresponding impairment of participation in group companies was made in the previous fiscal year). The impairment of Participations in group companies is accounted for in the Parent company income statement on the line Result from participations in group companies.
Note 5 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 6 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 2011 – April 30 2012. No additional risks beyond those described therein have been judged significant.
The Board of Directors and CEOof Oasmia Pharmaceuti cal AB ensures that this Year -end 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 face.
UppsaladenJune7, 2013
Joel Citron, Chairman Martin Nicklasson, Member
Jan Lundberg, Member Prof. Dr. Horst Domdey, Member
Bo Cederstrand, Member Julian Aleksov, Member and Chief Executive Officer
The information in this Year -end report is such that Oasmia Pharmaceutical (publ) must publish according to the code of trade in financial instruments. The information was delivered for publication on June 7, 2013 at 9.00
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 report has not been reviewed by the company auditors.
Dividends
The Board of Directors does not intend to propos e any dividends for the fiscal year May 1, 2012 €April 30, 2013.
Annual Report
The Annual Report will be published on August 22, 2013 and will be available on the company website www.oasmia.com. The Annual Report may also be requested from Oasmia Pharmceutical AB by phone +46 18 50 54 40 or by e-mail [email protected]m
Annual General Meeting
The Annual General Meeting will be held on September 30, 2013 in the company offices in Uppsala. A notice for the Meeting is distributed four weeks before the Meeting at the latest. For more information, see the company website www.oasmia.com
COMPANY INFORMATION Oasmia Pharmaceutical AB (publ) Corp. Reg. No: 556332-667601 Domicile: Stockholm
Address and telephone number to the Main Office Vallongatan 1 752 28UPPSALA, SWEDEN +46 18 50 54 40 www.oasmia.com [email protected]
Questions concerning the report are answered by: Johan Edin, acting Head of PR & Communications +46 18 50 54 40
UPCOMING REPORT DATES
| Annual Report May 2012 – April 2013 | 2013-08-22 |
|---|---|
| Interim report May 2013 – July 2013 | 2013-09-06 |
| Interim report May 2013 – October 2013 | 2013-12-05 |
| Interim report May 2013 – January 2014 | 2014-03-06 |
| Year-end report May 2013 – April 2014 | 2014-06-05 |