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Vivesto — Interim / Quarterly Report 2011
Mar 9, 2011
3124_10-q_2011-03-09_eba5cd6e-1865-4e2b-a284-36ba80404ed0.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB
Interim report for the period May 2010 – January 2011 €
Pages 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 11-25. 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 January 31, 2011 which was 8.8980 SEK per one EUR. The text in pages 2-3 include a few figures in SEK because these are very firmly denominated in SEK
STOCK LISTING IN FRANKFURT
THE PERIOD May 1 2010 – January 31 2011
- Consolidated net sales amounted to € 12 thousands (2,836) 1
- Operating income amounted to € -4,786 thousands (-1,098)
- Net income after tax amounted to € -4,995 thousands (-1,311)
- Earnings per share was € -0.12 (-0.04)
- Comprehensive income amounted to € -4,995 thousands (-1,311)
THIRD QUARTER November 1 2010 – January 31 2011
- Consolidated net sales amounted to € 7 thousands (37)
- Operating income amounted to € -1,747 thousands (-1,313)
- Net income after tax amounted to € -1,756 thousands (-1,314)
- Earnings per share was € -0.04 (-0.03)
- Comprehensive income amounted to € -1,756 thousands (-1,314)
- The share was listed at Frankfurt Stock Exchange
- The new share issue with preferential rights carried out
- Debt/Equity ratio at 0%
EVENTS AFTER CLOSING DAY
- Oasmia has closed an agreement with Baxter Oncology for future commercial production
- Björn Björnsson new Chairman of the Board
1 The numbers in parentheses concerns results for the corresponding period previous year
KEY EVENTS DURING THE PERIOD
OASMIA HUMAN HEALTH
Paclical®
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 87 clinics in 16 European countries. The number of patients will amount to 650 and the majority is now included in the study.
Docecal®
Preparations are being made to bring Oasmia's product candidate Docecal® into the clinical phase. Docecal® is a novel patented formulation of docetaxel (Taxotere®) with improved chemical properties intended for treatment of prostate cancer and breast cancer
OASMIA ANIMAL HEALTH
Paccal® Vet
In August 2010, Oasmia submitted a complete application for registration of Paccal® Vet in the USA and EU for treatment of dogs with mastocytoma. It is stated in the registration file that the product will be manufactured in the in-house plant in Uppsala. The audit by the authorities is still on-going, but none of these approvals had been obtained at the end of the period. The goal is to launch the product in 2011
Doxophos® Vet
A study in dogs carried out by Oasmia in Canada to investigate the safety and pharmacokinetics showed that the proposed doses of Doxophos® Vet were very well tolerated.
THE COMPANY
The share now listed at Frankfurt Stock Exchange
On January 24, 2011, the Oasmia share was listed on Frankfurt Stock Exchange, General Standard, as the first Swedish company on the regular stock list in Frankfurt. The share is previously listed on NASDAQ OMX Stockholm and Oasmia is now listed on two stock markets, a dual listing. Co-applicant in Frankfurt was Silvia Quandt & Cie. AG together with biw Bank für Investments und Wertpapiere AG.
Share issue with preferential rights performed
In the end of 2010, the company carried out a fully committed new share issue with preferential rights amounting to SEK 239 million. The share issue concerned 14.5 million shares and the subscription price was SEK 16.50 per share. The number of share before the new share issue was 37,612,858 and after 52,079,341.
Debt/Equity ratio 0 %
The company has paid all loans carrying interest after the recent share issue and the debt/equity ratio is 0 %.
At the Annual General Meeting in September 2010, Björn Björnsson was elected as a new Member of the Board and the Board was expanded to five members.
In September, the company announced that it had appointed Carnegie Investment Bank AB as advisor to determine the possibilities of providing the company with capital for continued product development and to ensure future production.
In September, it was announced that the principal owner Oasmia S.A had placed another credit facility amounting to SEK 40 million at Oasmia Pharmaceutical AB's disposal, increasing the available credit to SEK 100 million.
In July, the company signed a Standby Equity Distribution Agreement (SEDA-agreement) with YA Global Master SPV Ltd (YA Global) which is controlled by the USA-based Yorkville Advisors LLC. The agreement means that YA Global will provide up to SEK 75 million through subscription of newly issued Oasmia shares for a period of 36 months after the closing of the agreement. As of January 31, no such share issue had been made.
In June, the Oasmia share was listed on NASDAQ OMX Stockholm and Remium was appointed as liquidity provider for the Oasmia share.
EVENTS AFTER CLOSING DAY
Oasmia has closed an agreement with Baxter Oncology for future commercial production
Oasmia has signed an agreement with Baxter Oncology to ensure future large-scale production of the company products. The agreement primarily concerns commercial manufacture of the product candidates Paccal® Vet and Paclical® for the global market. Initially, Paccal® Vet will be manufactured in the Oasmia facility in Uppsala, while technology and processes are transferred to the Baxter facility in Halle, Westfalen, Germany. The cooperation with Baxter is a very important step in Oasmia's growth strategy and is a requirement for the company's success. The cooperation may be expanded to include other product candidates from Oasmia's product portfolio and is an important step to accelerate their launch.
Björn Björnsson new Chairman of the Board
Björn Björnsson, who was elected into the company board in 2010, has been appointed as new chairman after Bo Cederstrand announced that he wished to resign as chairman. Bo Cederstrand is still a Member of the Board. Peter Ström, who has been a member of the board since 2006, has been appointed as deputy chairman.
OTHER INFORMATION
In February, 2011, Deutsche Börse announced that it will acquire NYSE Euronext (NYSE is short for New York Stock Exchange). Deutche Börse manages Frankfurt Stock Exchange, among others. Oasmia is convinced that the dual listing in Stockholm and Frankfurt has put the company in a comfortable position on a stock market that is becoming more international.
PRESS RELEASE FROM OASMIA S.A.
The Board of Directors notes that Oasmia S.A. has made a number of clarifications concerning for instance the ownership in Oasmia S.A. and thereby indirectly in Oasmia Pharmaceutical AB. The Board apologizes for the errors concerning the ownership in previous prospectus and annual report, but has the view that these do not hold any material significance for the image of Oasmia Pharmaceutical AB.
FINANCIAL PROSPECTS
A deciding factor for Oasmia's financial prospects is the launch dates for the products we develop. Launch means that the company starts to generate revenues through milestone payments and royalties.
The phase closest to launch is registration. After submission of an application for registration, Oasmia is dependent on the pharmaceutical authorities' process of the application. The company cannot affect the processing time in other ways than providing rapid answers to possible questions.
The company aims to launch its first product for the veterinary market, Paccal® Vet, in 2011. License and distribution agreements are in place for the main world markets.
The company aims to launch its first product for the human market, Paclical®, in 2012. The Board of Directors makes the assessment that there are very good possibilities for licensing in the human market.
The Board has set a goal that the debt/equity ratio shall not exceed 50 %. At the end of the third quarter (January 31), the debt/equity ratio was 0 %.
The business is financed by equity, credits and licensing. The management continuously works with these instruments. The recently carried out new share issue means that the company is financed by equity for some time and is independent of credits and licensing for this period.
BUSINESS ACTIVITES
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 expires 2023. Furthermore, additional patent applications have been submitted which could extend the patent protection to the year 2028.
The business model requires Oasmia to take responsibility for the supply chain – from product idea to final product and licensing to companies who have the right resources for marketing and sales.
The product candidates undergo clinical trials and the pharmaceuticals used in these are made by Oasmia in the in-house production facility in Uppsala. The clinical trials are controlled by Oasmia personnel who commit clinics and contract research organizations (CRO). Thereafter, an application of registration of the product for sales on the market follows. In such an application, the product and its manufacturing process are included.
Oasmias in-house production facility may also be used for production of pharmaceuticals for market sales but only in a small scale. The application submitted in the USA and EU for registration of Paccal® Vet is based on manufacture of the product in the facility in Uppsala. To provide the market with larger volumes, Oasmia has closed an agreement with a contract manufacturer which can provide a much larger capacity than the in-house facility. Such a change in producing unit requires a specific approval of pharmaceutical authorities. Oasmia has not applied for such an approval yet.
For upcoming products in the portfolio, including Paclical®, the intention is to apply for approval with a contract manufacturer as producer of the pharmaceutical already from the start.
Final labelling, packing and distribution will be made from the in-house facility in Uppsala.
FINANCAL INFORMATION
Consolidated Income Statement in brief
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 7 | 37 | 12 | 2,836 | 3,455 |
| Capitalized development cost | 3,017 | 1,671 | 7,390 | 6,702 | 9,063 |
| Operating income | -1,747 | -1,313 | -4,786 | -1,098 | -1,681 |
| Net income after tax | -1,756 | -1,314 | -4,995 | -1,311 | -1,917 |
| Earnings per share (€), before and after dilution | -0.04 | -0.03 | -0.12 | -0.04 | -0.05 |
| Comprehensive income for the period | -1,756 | -1,314 | -4,995 | -1,311 | -1,917 |
Net sales
Net sales for the period amounted to € 12 thousands (2,836) and only consisted of compassionate sales of pharmaceuticals. Unlike the corresponding period previous year, the group had no license revenues.
Capitalized development cost
Capitalized development cost consists of the company's investments in clinical Phase III trials. They amounted for the period to € 7,390 thousands (6,702). The increase is due to the fact that the clinical study for Paclical® is in a more intense stage compared to the previous year.
Operating expenses
The total operating expenses, excluding depreciations and impairments, amounted to € 11,818 thousands (10,338). The increase is attributable to a higher intensity in the clinical studies, production development at the Uppsala facility and an expanded workforce. The number of employees at the end of the period was 72 (58).
Of the operating expenses, 63 % (65) were capitalized as Capitalized development costs.
Net profit for the period
The net profit for the period was € -4,995 thousands (-1,311). The difference in profit is attributable to the fact that there were no license revenues in the period (previous year € 2,592 thousands) and to the expansion which resulted in increased operating expenses.
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 period amounted to € 10,231 thousands (2,000). Equity at the same time amounted to € 35,478 thousands (16,542). At the end of the period, the equity/assets ratio was 93 % (87) and the debt/equity ratio 0 % (0).
Cash flow and Capital expenditures
Cash flow from operating activities in the period amounted to € -4,555 thousands (-953). The change compared to the previous year consisted mainly of license revenues in the previous year and of increased operating expenses.
Capital expenditures amounted to € 8,607 thousands (6,917) where investments in intangible assets amounted to € 7,593 thousands (6,795) and investments in property, plant and equipment amounted to € 1,015 thousands (122). Investments in intangible assets consisted of capitalized development costs € 7,390 thousands and patents € 202 thousands. Investments in property, plant and equipment mainly concerned the production facility in Uppsala. In the current fiscal year, an extensive upscaling of the production facility is currently being made.
The financing in the period was made by an increase in loans until the end of November when a new share issue with preferential rights was carried out. The cash quantity of the share issue amounted to € 16,670 thousands
after issue expenses. The remaining quantity of the share issue, € 7,867 thousands was paid by Oasmia S.A, the principal owner of Oasmia, by offset of a claim by the corresponding amount.
The parent company
The parent company net sales in the quarter amounted to € 12 thousands (2,620) and net income after tax amounted to € -4,992 thousands (-1,278). The parent company liquid assets at the end of the quarter amounted to € 10,231 thousands (1,973).
Key ratios and other information
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* |
52,079 | 38,403 | 52,079 | 38,403 | 38,403 |
| Average number of shares (in thousands) before and after dilution* | 47,620 | 37,830 | 41,475 | 35,953 | 36,550 |
| Earnings per share in €, before and after dilution* | -0.04 | -0.03 | -0.12 | -0.04 | -0.05 |
| Equity per share, €* | 0.68 | 0.43 | 0.68 | 0.43 | 0.41 |
| Equity/Assets ratio, % | 93 | 87 | 93 | 87 | 79 |
| Net liability, € thousands | -10,232 | -1,917 | -10,232 | -1,917 | 1,064 |
| Debt/Equity ratio, % | 0 | 0 | 0 | 0 | 7 |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 72 | 58 | 72 | 58 | 64 |
* 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
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 7 | 37 | 12 | 2,836 | 3,455 |
| Capitalized development cost | 3,017 | 1,671 | 7,390 | 6,702 | 9,063 |
| Other operating income | 3 | - | 14 | - | - |
| Raw materials, consumables and goods for resale | -204 | -746 | -1,065 | -1,528 | -2,118 |
| Other external expenses | -3,379 | -1,343 | -7,681 | -6,423 | -8,363 |
| Employee benefit expenses | -1,056 | -830 | -3,072 | -2,387 | -3,306 |
| Depreciation/amortization and impairment | -134 | -101 | -384 | -298 | -406 |
| Other operating expenses | - | - | 0 | - | -8 |
| Operating income | -1,747 | -1,313 | -4,786 | -1,098 | -1,681 |
| Financial income | 24 | 10 | 26 | 47 | 46 |
| Financial expenses | -33 | -11 | -235 | -259 | -282 |
| Financial items, net | -10 | -1 | -209 | -213 | -235 |
| Income before taxes | -1,756 | -1,314 | -4,995 | -1,311 | -1,917 |
| Taxes | 0 | 0 | 0 | 0 | 0 |
| Income for the period | -1,756 | -1,314 | -4,995 | -1,311 | -1,917 |
| Income for the period attributable to: | |||||
| Equity holders of the Parent company | -1,756 | -1,313 | -4,995 | -1,310 | -1,912 |
| Minority shareholding | 0 | 0 | -1 | -1 | -4 |
| Earnings per share: | |||||
| Before dilution, € | -0.04 | -0.03 | -0.12 | -0.04 | -0.05 |
| After dilution, € | -0.04 | -0.03 | -0.12 | -0.04 | -0.05 |
Consolidated Statement of Comprehensive income
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Income for the period | -1,756 | -1,314 | -4,995 | -1,311 | -1,917 |
| Comprehensive income for the period | -1,756 | -1,314 | -4,995 | -1,311 | -1,917 |
| Comprehensive income for the period attributable to: | |||||
| Equity holders of the Parent company | -1,756 | -1,313 | -4,995 | -1,310 | -1,912 |
| Minority shareholding | 0 | 0 | -1 | -1 | -4 |
| Comprehensive Earnings per share: | |||||
| Before dilution, € | -0.04 | -0.03 | -0.12 | -0.04 | -0.05 |
| After dilution, € | -0.04 | -0.03 | -0.12 | -0.04 | -0.05 |
Consolidated statement of financial position
| € thousands | 2011-01-31 | 2010-01-31 | 2010-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 3,029 | 2,129 | 2,322 |
| Capitalized development cost | 23,221 | 13,469 | 15,831 |
| Other intangible assets | 1,031 | 904 | 904 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 27,281 | 16,502 | 19,058 |
| Current assets | |||
| Inventories | 11 | 11 | 11 |
| Trade receivables | - | 1 | 7 |
| Other current receivables | 346 | 190 | 235 |
| Prepaid expenses and accrued income | 455 | 258 | 276 |
| Liquid assets | 10,232 | 2,000 | 604 |
| Total Current assets | 11,043 | 2,460 | 1,132 |
| TOTAL ASSETS | 38,324 | 18,961 | 20,190 |
| EQUITY | |||
| Equity attributed to equity holders in the Parent Company | |||
| Share capital | 585 | 423 | 423 |
| Other capital provided | 46,457 | 22,083 | 22,083 |
| Retained earnings | -11,570 | -5,973 | -6,575 |
| Total | 35,472 | 16,532 | 15,930 |
| Minority shareholding | 6 | 9 | 6 |
| Total equity | 35,478 | 16,542 | 15,936 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 1,730 | 1,730 | 1,730 |
| Deferred tax liabilities | 1 | 1 | 1 |
| Total Non-current liabilities | 1,731 | 1,731 | 1,731 |
| Current liabilities | |||
| Liabilities to credit institutions | - | - | 482 |
| Short-term borrowings | - | 84 | 1,186 |
| Trade payables | 438 | 90 | 233 |
| Other current liabilities | 164 | 115 | 135 |
| Accrued expenses and prepaid income | 513 | 399 | 487 |
| Total Current liabilities | 1,114 | 688 | 2,522 |
| Total Liabilities | 2,845 | 2,419 | 4,253 |
| TOTAL EQUITY AND LIABILITIES | 38,324 | 18,961 | 20,190 |
Contingent liabilities Pledged assets
Consolidated statement of changes in equity
| Attributable to equity holders in Parent company | |||||
|---|---|---|---|---|---|
| € thousands | Share capital | Other paid-up capital |
Retained earnings |
Minority shareholding |
Total equity |
| Opening balance as of May 1, 2009 | 376 | 11,155 | -4,663 | 11 | 6,879 |
| Comprehensive income for the period | - | - | -1,310 | -1 | -1,311 |
| New share issues | 46 | 11,509 | - | - | 11,556 |
| Issue expenses | - | -581 | - | - | -581 |
| Closing balance as of January 31, 2010 | 423 | 22,083 | -5,973 | 9 | 16,542 |
| Opening balance as of May 1, 2009 | 376 | 11,155 | -4,663 | 11 | 6,879 |
| Comprehensive income for the year | - | - | -1,912 | -4 | -1,917 |
| New share issues | 46 | 11,509 | - | - | 11,556 |
| Issue expenses | - | -581 | - | - | -581 |
| Closing balance as of April 30, 2010 | 423 | 22,083 | -6,575 | 6 | 15,936 |
| Opening balance as of May 1, 2010 | 423 | 22,083 | -6,575 | 6 | 15,936 |
| Comprehensive income for the period | - | - | -4,995 | -1 | -4,995 |
| New share issues | 163 | 26,663 | - | - | 26,826 |
| Issue expenses | - | -2,289 | - | - | -2,289 |
| Closing balance as of January 31, 2011 | 585 | 46,457 | -11,570 | 6 | 35,478 |
Consolidated Cash flow statement
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Operating activities | |||||
| Operating income before financial items | -1,747 | -1,313 | -4,786 | -1,098 | -1,681 |
| Depreciation/amortization | 134 | 101 | 384 | 298 | 406 |
| Impairment of inventory | - | 7 | - | 34 | 34 |
| Disposals of intangible assets | - | - | 0 | - | 8 |
| Interest received | 24 | 10 | 26 | 47 | 46 |
| Interest paid | 46 | -11 | -156 | -223 | -245 |
| Cash flow from operating activities before working capital changes |
-1,543 | -1,206 | -4,532 | -942 | -1,433 |
| Change in working capital | |||||
| Change in inventories | - | 110 | - | 268 | 268 |
| Change in trade receivables | - | 0 | 7 | 262 | 256 |
| Change in other current receivables | -429 | -123 | -289 | -130 | -193 |
| Change in trade payables | -512 | -91 | 205 | -250 | -107 |
| Change in other current liabilities | -121 | 9 | 55 | -160 | -53 |
| Cash flow from current operations | -2,605 | -1,302 | -4,555 | -953 | -1,263 |
| Investing activities | |||||
| Investments in intangible fixed assets | -3,017 | -1,738 | -7,593 | -6,795 | -9,190 |
| Investments in property, plant and equipment | -264 | -55 | -1,015 | -122 | -398 |
| Cash flow from investing activities | -3,281 | -1,793 | -8,607 | -6,917 | -9,588 |
| Financing activities | |||||
| Decrease in liabilities to credit institutions | -557 | -288 | -482 | -827 | -345 |
| Increase in long-term liabilities | - | - | - | 1,728 | 1,728 |
| New share issues | 18,959 | 4,833 | 18,959 | 8,326 | 8,326 |
| Issue expenses | -2,289 | -242 | -2,289 | -581 | -581 |
| New loans | - | - | 6,602 | 1,625 | 2,810 |
| Amortization of loans | - | -83 | - | -511 | -595 |
| Cash flow from financing activities | 16,113 | 4,220 | 22,790 | 9,759 | 11,343 |
| Cash flow for the period Cash and cash equivalents at the beginning of |
10,227 | 1,126 | 9,628 | 1,889 | 493 |
| the period | 5 | 874 | 604 | 111 | 111 |
| Cash and cash equivalents at the end of the period |
10,232 | 2,000 | 10,232 | 2,000 | 604 |
Oasmia Pharmaceutical AB (publ)
Interim report for the period May 2010 – January 2011
STOCK LISTING IN FRANKFURT
THE PERIOD May 1 2010 – January 31 2011
- Consolidated net sales amounted to TSEK 106 (25 236) 2
- Operating income amounted to TSEK -42 589 (-9 774)
- Net income after tax amounted to TSEK -44 447 (-11 667)
- Earnings per share was SEK -1,07 (-0,32)
- Comprehensive income amounted to TSEK -44 447 (-11 667)
THIRD QUARTER November 1 2010 – January 31 2011
- Consolidated net sales amounted to TSEK 64 (326)
- Operating income amounted to TSEK -15 542 (-11 679)
- Net income after tax amounted to TSEK -15 628 (-11 688)
- Earnings per share was SEK -0,33 (-0,31)
- Comprehensive income amounted to TSEK -15 628 (-11 688)
- The share was listed at Frankfurt Stock Exchange
- The new share issue with preferential rights carried out
- Debt/Equity ratio at 0%
EVENTS AFTER CLOSING DAY
- Oasmia has closed an agreement with Baxter Oncology for future commercial production
- Björn Björnsson new Chairman of the Board
2 The numbers in parentheses concerns results for the corresponding period previous year
KEY EVENTS DURING THE PERIOD
OASMIA HUMAN HEALTH
Paclical®
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 87 clinics in 16 European countries. The number of patients will amount to 650 and the majority is now included in the study.
Docecal®
Preparations are being made to bring Oasmia's product candidate Docecal® into the clinical phase. Docecal® is a novel patented formulation of docetaxel (Taxotere®) with improved chemical properties intended for treatment of prostate cancer and breast cancer.
OASMIA ANIMAL HEALTH
Paccal® Vet
In August 2010, Oasmia submitted a complete application for registration of Paccal® Vet in the USA and EU for treatment of dogs with mastocytoma. It is stated in the registration file that the product will be manufactured in the in-house plant in Uppsala. The audit by the authorities is still on-going, but none of these approvals had been obtained at the end of the period. The goal is still to launch the product in 2011.
Doxophos® Vet
A study in dogs carried out by Oasmia in Canada to investigate the safety and pharmacokinetics showed that the proposed doses of Doxophos® Vet were very well tolerated.
THE COMPANY
The share now listed at Frankfurt Stock Exchange
On January 24, 2011, the Oasmia share was listed on Frankfurt Stock Exchange, General Standard, as the first Swedish company on the regular stock list in Frankfurt. The share is previously listed on NASDAQ OMX Stockholm and Oasmia is now listed on two stock markets, a dual listing. Co-applicant in Frankfurt was Silvia Quandt & Cie. AG together with biw Bank für Investments und Wertpapiere AG.
Share issue with preferential rights performed
In the end of 2010, the company carried out a fully committed new share issue with preferential rights amounting to SEK 239 million. The share issue concerned 14.5 million shares and the subscription price was SEK 16.50 per share. The number of share before the new share issue was 37 612 858 and after 52 079 341.
Debt/Equity ratio 0 %
The company has paid all loans carrying interest after the recent share issue and the debt/equity ratio is 0 %.
At the Annual General Meeting in September 2010, Björn Björnsson was elected as a new Member of the Board and the Board was expanded to five members.
In September, the company announced that it had appointed Carnegie Investment Bank AB as advisor to determine the possibilities of providing the company with capital for continued product development and to ensure future production.
In September, it was announced that the principal owner Oasmia S.A had placed another credit facility amounting to SEK 40 million at Oasmia Pharmaceutical AB's disposal, increasing the available credit to SEK 100 million.
In July, the company signed a Standby Equity Distribution Agreement (SEDA-agreement) with YA Global Master SPV Ltd (YA Global) which is controlled by the USA-based Yorkville Advisors LLC. The agreement means that YA Global will provide up to SEK 75 million through subscription of newly issued Oasmia shares for a period of 36 months after the closing of the agreement. As of January 31, no such share issue had been made.
In June, the Oasmia share was listed on NASDAQ OMX Stockholm and Remium was appointed as liquidity provider for the Oasmia share.
EVENTS AFTER CLOSING DAY
Oasmia has closed an agreement with Baxter Oncology for future commercial production
Oasmia has signed an agreement with Baxter Oncology to ensure future large-scale production of the company products. The agreement primarily concerns commercial manufacture of the product candidates Paccal® Vet and Paclical® for the global market. Initially, Paccal® Vet will be manufactured in the Oasmia facility in Uppsala, while technology and processes are transferred to the Baxter facility in Halle, Westfalen, Germany. The cooperation with Baxter is a very important step in Oasmia's growth strategy and is a requirement for the company's success. The cooperation may be expanded to include other product candidates from Oasmia's product portfolio and is an important step to accelerate their launch.
Björn Björnsson new Chairman of the Board
Björn Björnsson, who was elected into the company board in 2010, has been appointed as new chairman after Bo Cederstrand announced that he wished to resign as chairman. Bo Cederstrand is still a Member of the Board. Peter Ström, who has been a Member of the Board since 2006, has been appointed as deputy chairman.
OTHER INFORMATION
In February, 2011, Deutsche Börse announced that it will acquire NYSE Euronext (NYSE is short for New York Stock Exchange). Deutche Börse manages Frankfurt Stock Exchange, among others. Oasmia is convinced that the dual listing in Stockholm and Frankfurt has put the company in a comfortable position on a stock market that is becoming more international.
PRESS RELEASE FROM OASMIA S.A.
The Board of Directors notes that Oasmia S.A. has made a number of clarifications concerning for instance the ownership in Oasmia S.A. and thereby indirectly in Oasmia Pharmaceutical AB. The Board apologizes for the errors concerning the ownership in previous prospectus and annual report, but has the view that these do not hold any material significance for the image of Oasmia Pharmaceutical AB.
FINANCIAL PROSPECTS
A deciding factor for Oasmia's financial prospects is the launch dates for the products we develop. The launch of a product means that the company starts to generate revenues through milestone payments and royalties.
The phase closest to launch is registration. After submission of an application for registration, Oasmia is dependent on the pharmaceutical authorities' process of the application. The company cannot affect the processing time in other ways than providing rapid answers to possible questions.
The company aims to launch its first product for the veterinary market, Paccal® Vet, in 2011. License and distribution agreements are in place for the main world markets.
The company aims to launch its first product for the human market, Paclical®, in 2012. The Board of Directors makes the assessment that there are very good possibilities for licensing in the human market.
The Board has set a goal that the debt/equity ratio shall not exceed 50 %. At the end of the third quarter (January 31), the debt/equity ratio was 0 %.
The business is financed by equity, credits and licensing. The management continuously works with these instruments. The recently carried out new share issue means that the company is financed by equity for some time and is independent of credits and licensing for this period.
BUSINESS ACTIVITES
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 expires 2023. Furthermore, additional patent applications have been submitted which could extend the patent protection to the year 2028.
The business model requires Oasmia to take responsibility for the whole supply chain – from product idea to final product and licensing to companies who have the right resources for marketing and sales.
The product candidates undergo clinical trials and the pharmaceuticals used in these are made by Oasmia in the in-house production facility in Uppsala. The clinical trials are controlled by Oasmia personnel who commit clinics and contract research organizations (CRO). Thereafter, an application of 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 may also be used for production of pharmaceuticals for market sales but only in a small scale. The application submitted in the USA and EU for registration of Paccal® Vet is based on manufacture of the product in the facility in Uppsala. To provide the market with greater volumes, Oasmia has closed an agreement with a contract manufacturer which can provide a much larger capacity than the in-house facility. Such a change in producing unit requires a specific approval of pharmaceutical authorities. Oasmia has not applied for such an approval.
For upcoming products in the portfolio, including Paclical®, the intention is to apply for approval with a contract manufacturer as producer of the pharmaceutical already from the start.
Final labelling, packing and distribution will be made from the in-house facility in Uppsala.
FINANCAL INFORMATION
Consolidated Income Statement in brief
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| TSEK | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 64 | 326 | 106 | 25 236 | 30 741 |
| Capitalized development cost | 26 846 | 14 864 | 65 759 | 59 633 | 80 643 |
| Operating income | -15 542 | -11 679 | -42 589 | -9 774 | -14 961 |
| Net income after tax | -15 628 | -11 688 | -44 447 | -11 667 | -17 054 |
| Earnings per share (SEK), before and after dilution | -0,33 | -0,31 | -1,07 | -0,32 | -0,47 |
| Comprehensive income for the period | -15 628 | -11 688 | -44 447 | -11 667 | -17 054 |
Net sales
Net sales for the period amounted to TSEK 106 (25 236) and only consisted of compassionate sales of pharmaceuticals. Unlike the corresponding period previous year, the group had no license revenues.
Capitalized development cost
Capitalized development cost consists of the company's investments in clinical Phase III trials. They amounted for the period to TSEK 65 759 (59 633). The increase is due to the fact that the clinical study for Paclical® is in a more intense stage compared to the previous year. Capitalized development costs per product candidate are displayed in note 3.
Operating expenses
The total operating expenses, excluding depreciations and impairments, amounted to TSEK 105 160 (91 988). The increase is attributable to a higher intensity in the clinical studies, production development at the Uppsala facility and an expanded workforce. The number of employees at the end of the period was 72 (58).
Of the operating expenses, 63 % (65) were capitalized as Capitalized development costs.
The Oasmia share has been admitted for trade at two stock markets in the fiscal year. Fees for both stock markets are found in Note 8.
Net profit for the period
The net profit for the period was TSEK -44 447 (-11 667). The difference in profit is attributable to the fact that there were no license revenues in the period (previous year TSEK 23 065) and to the expansion which resulted in increased operating expenses.
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 period amounted to TSEK 91 041 (17 799). Equity at the same time amounted to TSEK 315 684 (147 190). At the end of the period, the equity/assets ratio was 93 % (87) and the debt/equity ratio 0 % (0).
Cash flow and Capital expenditures
Cash flow from operating activities in the period amounted to TSEK -40 527 (-8 481). The change compared to the previous year consisted mainly of license revenues in the previous year and of increased operating expenses.
Capital expenditures amounted to TSEK 76 589 (61 548) where investments in intangible assets amounted to TSEK 67 559 (60 462) and investments in property, plant and equipment amounted to TSEK 9 030 (1 086). Investments in intangible assets consisted of capitalized development costs TSEK 65 759 and patents TSEK 1 800. Investments in property, plant and equipment mainly concerned the production facility in Uppssala. In the current fiscal year, an extensive upscaling of the production facility is currently being made.
The financing in the period was made by an increase in loans until the end of November when a new share issue with preferential rights was carried out. The cash quantity of the share issue amounted to TSEK 148 328 after
issue expenses. The remaining quantity of the share issue, TSEK 70 000, was paid by Oasmia S.A, the principal owner of Oasmia, by offset of a claim by the corresponding amount.
The parent company
The parent company net sales in the period amounted to TSEK 106 (23 312) and net income after tax amounted to TSEK -44 416 (-11 376). The parent company liquid assets at the end of the period amounted to TSEK 91 032 (17 558).
Key ratios and other information
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | |
|---|---|---|---|---|---|
| Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* |
52 079 | 38 403 | 52 079 | 38 403 | 38 403 |
| Average number of shares (in thousands) before and after dilution* | 47 620 | 37 830 | 41 475 | 35 953 | 36 550 |
| Earnings per share in SEK, before and after dilution* | -0,33 | -0,31 | -1,07 | -0,32 | -0,47 |
| Equity per share, SEK* | 6,06 | 3,83 | 6,06 | 3,83 | 3,69 |
| Equity/Assets ratio, % | 93 | 87 | 93 | 87 | 79 |
| Net liability, TSEK | -91 041 | -17 054 | -91 041 | -17 054 | 9 467 |
| Debt/Equity ratio, % | 0 | 0 | 0 | 0 | 7 |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 72 | 58 | 72 | 58 | 64 |
* 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
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 64 | 326 | 106 | 25 236 | 30 741 | |
| Capitalized development cost | 26 846 | 14 864 | 65 759 | 59 633 | 80 643 | |
| Other operating income | 24 | - | 123 | - | - | |
| Raw materials, consumables and goods for resale | -1 815 | -6 636 | -9 474 | -13 597 | -18 842 | |
| Other external expenses | -30 070 | -11 952 | -68 348 | -57 148 | -74 412 | |
| Employee benefit expenses | -9 400 | -7 386 | -27 338 | -21 243 | -29 413 | |
| Depreciation/amortization and impairment | -1 192 | -896 | -3 416 | -2 656 | -3 612 | |
| Other operating expenses | - | - | -1 | - | -68 | |
| Operating income | -15 542 | -11 679 | -42 589 | -9 774 | -14 961 | |
| Financial income | 211 | 91 | 231 | 415 | 411 | |
| Financial expenses | -297 | -100 | -2 089 | -2 308 | -2 505 | |
| Financial items, net | -86 | -9 | -1 858 | -1 893 | -2 094 | |
| Income before taxes | -15 628 | -11 688 | -44 447 | -11 667 | -17 055 | |
| Taxes | 2 | 0 | 0 | 0 | 0 | 0 |
| Income for the period | -15 628 | -11 688 | -44 447 | -11 667 | -17 054 | |
| Income for the period attributable to: | ||||||
| Equity holders of the Parent company | -15 626 | -11 685 | -44 442 | -11 656 | -17 016 | |
| Minority shareholding | -2 | -3 | -5 | -11 | -38 | |
| Earnings per share | ||||||
| Before dilution, SEK | -0,33 | -0,31 | -1,07 | -0,32 | -0,47 | |
| After dilution, SEK | -0,33 | -0,31 | -1,07 | -0,32 | -0,47 | |
| Consolidated Statement of Comprehensive | ||||||
| income | ||||||
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | ||
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Income for the period | -15 628 | -11 688 | -44 447 | -11 667 | -17 054 | |
| Comprehensive income for the period | -15 628 | -11 688 | -44 447 | -11 667 | -17 054 | |
| Comprehensive income for the period attributable to: |
||||||
| Equity holders of the Parent company | -15 626 | -11 685 | -44 442 | -11 656 | -17 016 | |
| Minority shareholding | -2 | -3 | -5 | -11 | -38 | |
| Comprehensive Earnings per share | ||||||
| Before dilution, SEK | -0,33 | -0,31 | -1,07 | -0,32 | -0,47 | |
| After dilution, SEK | -0,33 | -0,31 | -1,07 | -0,32 | -0,47 |
Consolidated statement of financial position
| TSEK | Note | 2011-01-31 | 2010-01-31 | 2010-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 26 954 | 18 940 | 20 665 | |
| Capitalized development cost | 3 | 206 619 | 119 849 | 140 860 |
| Other intangible assets | 9 171 | 8 039 | 8 047 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 242 745 | 146 831 | 169 574 | |
| Current assets | ||||
| Inventories | 94 | 94 | 94 | |
| Trade receivables | - | 9 | 60 | |
| Other current receivables | 3 075 | 1 693 | 2 090 | |
| Prepaid expenses and accrued income | 4 047 | 2 294 | 2 460 | |
| Liquid assets | 91 041 | 17 799 | 5 372 | |
| Total Current assets | 98 257 | 21 888 | 10 076 | |
| TOTAL ASSETS | 341 003 | 168 719 | 179 650 | |
| EQUITY | ||||
| Equity attributed to equity holders in the Parent Company | ||||
| Share capital | 5 208 | 3 761 | 3 761 | |
| Other capital provided | 413 375 | 196 493 | 196 493 | |
| Retained earnings | -102 951 | -53 148 | -58 509 | |
| Total | 315 632 | 147 106 | 141 746 | |
| Minority shareholding | 52 | 84 | 57 | |
| Total equity | 315 684 | 147 190 | 141 803 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 15 397 | 15 397 | 15 397 | |
| Deferred tax liabilities | 7 | 7 | 7 | |
| Total Non-current liabilities | 15 404 | 15 404 | 15 404 | |
| Current liabilities | ||||
| Liabilities to credit institutions | - | - | 4 289 | |
| Short-term borrowings | 4 | - | 745 | 10 550 |
| Trade payables | 3 896 | 803 | 2 076 | |
| Other current liabilities | 1 457 | 1 028 | 1 197 | |
| Accrued expenses and prepaid income | 4 562 | 3 550 | 4 332 | |
| Total Current liabilities | 9 915 | 6 125 | 22 443 | |
| Total Liabilities | 25 318 | 21 529 | 37 847 | |
| TOTAL EQUITY AND LIABILITIES | 341 003 | 168 719 | 179 650 | |
| Contingent liabilities | 5 | |||
Pledged assets 5
Consolidated statement of changes in equity
| Attributable to equity holders in Parent com | |||||||
|---|---|---|---|---|---|---|---|
| pany | |||||||
| paid-up | Retained | Minority | |||||
| TSEK | Share capital | capital | earnings | shareholding | Total equity | ||
| Opening balance as of May 1, 2009 | 3 350 | 99 254 | -41 493 | 95 | 61 207 | ||
| Comprehensive income for the period | - | - | -11 656 | -11 | -11 667 | ||
| New share issues | 411 | 102 410 | - | - | 102 821 | ||
| Issue expenses | - | -5 171 | - | - | -5 171 | ||
| Closing balance as of January 31, 2010 | 3 761 | 196 493 | -53 148 | 84 | 147 190 | ||
| Opening balance as of May 1, 2009 | 3 350 | 99 254 | -41 493 | 95 | 61 207 | ||
| Comprehensive income for the year | - | - | -17 016 | -38 | -17 054 | ||
| New share issues | 411 | 102 410 | - | - | 102 821 | ||
| Issue expenses | - | -5 171 | - | - | -5 171 | ||
| Closing balance as of April 30, 2010 | 3 761 | 196 493 | -58 509 | 57 | 141 803 | ||
| Opening balance as of May 1, 2010 | 3 761 | 196 493 | -58 509 | 57 | 141 803 | ||
| Comprehensive income for the period | - | - | -44 442 | -5 | -44 447 | ||
| New share issues | 1 447 | 237 250 | - | - | 238 697 | ||
| Issue expenses | - | -20 369 | - | - | -20 369 | ||
| Closing balance as of January 31, 2011 | 5 208 | 413 375 | -102 951 | 52 | 315 684 |
Consolidated Cash flow statement
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Operating activities | ||||||
| Operating income before financial items | -15 542 | -11 679 | -42 589 | -9 774 | -14 961 | |
| Depreciation/amortization | 1 192 | 896 | 3 416 | 2 656 | 3 612 | |
| Impairment of inventory | - | 62 | - | 300 | 300 | |
| Disposals of intangible assets | - | - | 1 | - | 68 | |
| Interest received | 211 | 91 | 231 | 415 | 411 | |
| Interest paid | 408 | -100 | -1 384 | -1 981 | -2 178 | |
| Cash flow from operating activities before work | ||||||
| ing capital changes | -13 731 | -10 730 | -40 325 | -8 385 | -12 748 | |
| Change in working capital | ||||||
| Change in inventories | - | 975 | - | 2 383 | 2 383 | |
| Change in trade receivables | - | -3 | 60 | 2 328 | 2 277 | |
| Change in other current receivables | -3 817 | -1 096 | -2 573 | -1 158 | -1 722 | |
| Change in trade payables | -4 559 | -811 | 1 821 | -2 223 | -950 | |
| Change in other current liabilities | -1 073 | 83 | 490 | -1 426 | -475 | |
| Cash flow from operating activities | -23 181 | -11 582 | -40 527 | -8 481 | -11 235 | |
| Investing activities | ||||||
| Investments in intangible fixed assets | -26 846 | -15 463 | -67 559 | -60 462 | -81 773 | |
| Investments in property, plant and equipment | -2 346 | -487 | -9 030 | -1 086 | -3 541 | |
| Cash flow from investing activities | -29 192 | -15 950 | -76 589 | -61 548 | -85 315 | |
| Financing activities | ||||||
| Decrease in liabilities to credit institutions | -4 956 | -2 561 | -4 289 | -7 356 | -3 067 | |
| Increase in long-term liabilities | - | - | - | 15 373 | 15 373 | |
| New share issues | 168 697 | 43 000 | 168 697 | 74 083 | 74 083 | |
| Issue expenses | -20 369 | -2 150 | -20 369 | -5 171 | -5 171 | |
| New loans | 4 | - | - | 58 745 | 14 457 | 25 007 |
| Amortization of loans | - | -737 | - | -4 546 | -5 290 | |
| Cash flow from financing activities | 143 372 | 37 552 | 202 784 | 86 840 | 100 934 | |
| Cash flow for the period | 90 999 | 10 019 | 85 669 | 16 811 | 4 384 | |
| Cash and cash equivalents at the beginning of | ||||||
| the period | 42 | 7 780 | 5 372 | 988 | 988 | |
| Cash and cash equivalents at the end of the period |
91 041 | 17 799 | 91 041 | 17 799 | 5 372 |
Parent Company Income statement
| 2010/11 | 2009/10 | 2010/11 | 2009/10 | 2009/10 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 64 | -21 | 106 | 23 312 | 28 817 | |
| Capitalized development cost | 26 846 | 14 864 | 65 759 | 59 633 | 80 643 | |
| Other operating income | 24 | - | 123 | 125 | 125 | |
| Raw materials, consumables and goods for resale | -1 814 | -5 532 | -9 434 | -10 688 | -15 869 | |
| Other external expenses | -30 023 | -11 883 | -68 198 | -56 884 | -74 051 | |
| Employee benefit expenses | -9 400 | -7 386 | -27 338 | -21 243 | -29 413 | |
| Depreciation/amortization and impairment of | ||||||
| property, plant, equipment and intangible assets | -1 151 | -839 | -3 287 | -2 483 | -3 385 | |
| Operating income | -15 454 | -10 797 | -42 268 | -8 228 | -13 133 | |
| Result from participations in Group companies | 6 | -80 | -1 000 | -290 | -1 650 | -3 570 |
| Other interest revenues and similar revenues | 210 | 91 | 231 | 415 | 411 | |
| Interest cost and similar costs | -297 | -84 | -2 089 | -1 912 | -2 109 | |
| Financial items, net | -167 | -993 | -2 148 | -3 148 | -5 268 | |
| Income after financial items | -15 620 | -11 789 | -44 416 | -11 376 | -18 401 | |
| Taxes | 2 | - | - | - | - | - |
| Income for the period | -15 620 | -11 789 | -44 416 | -11 376 | -18 401 |
Parent Company Balance Sheet
| TSEK | Note | 2011-01-31 | 2010-01-31 | 2010-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost | 3 | 206 619 | 119 849 | 140 860 |
| Concessions, patents, licenses, trademarks and | ||||
| similar rights | 8 884 | 7 500 | 7 630 | |
| Property, plant and equipment | ||||
| Equipment, tools, fixtures and fittings | 26 954 | 18 940 | 20 665 | |
| Financial assets Participations in group companies |
6 | 298 | 2 118 | 298 |
| Receivables from group companies | 5 | 4 | 4 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 242 761 | 148 412 | 169 458 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 94 | 94 | 94 | |
| 94 | 94 | 94 | ||
| Current receivables | ||||
| Trade receivables | - | -53 | 60 | |
| Receivables from group companies | 4 | 37 | 405 | 370 |
| Other current receivables | 3 074 | 1 658 | 2 019 | |
| Prepaid expenses and accrued income | 4 047 | 2 278 | 2 332 | |
| 7 158 | 4 287 | 4 782 | ||
| Cash and bank balances | 91 032 | 17 558 | 5 320 | |
| Total current assets | 98 284 | 21 939 | 10 196 | |
| TOTAL ASSETS | 341 045 | 170 351 | 179 653 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 5 208 | 3 761 | 3 761 | |
| Statutory reserve | 4 620 | 4 620 | 4 620 | |
| 9 828 | 8 381 | 8 381 | ||
| Non-restricted equity | ||||
| Share premium reserve | 413 375 | 196 493 | 196 493 | |
| Retained earnings | -63 030 | -44 628 | -44 628 | |
| Income for the period | -44 416 | -11 376 | -18 401 | |
| 305 929 | 140 489 | 133 464 | ||
| Total equity | 315 757 | 148 870 | 141 845 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 15 373 | 15 373 | 15 373 | |
| Total non-current liabilities | 15 373 | 15 373 | 15 373 | |
| Current liabilities | ||||
| Short term borrowings | 4 | - | 745 | 10 550 |
| Trade payables | 3 896 | 795 | 2 068 | |
| Liabilities to Credit institutions | - | - | 4 289 | |
| Other current liabilities | 1 457 | 1 019 | 1 197 | |
| Accrued expenses and prepaid income | 4 562 | 3 550 | 4 332 | |
| Total Current liabilities | 9 915 | 6 108 | 22 435 | |
| TOTAL EQUITY AND LIABILITIES | 341 045 | 170 351 | 179 653 | |
| Contingent liabilities and pledged assets Contingent liabilities |
- | - | - | |
| Pledged assets | 5 | 8 000 | 5 000 | 5 000 |
Parent Company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| Statutory | Non-restricted | |||
| TSEK | Share capital | reserve | equity | Total equity |
| Opening balance as of May 1, 2009 | 3 350 | 4 620 | 54 626 | 62 596 |
| New share issue | 411 | - | 102 410 | 102 821 |
| Issue expenses | - | - | -5 171 | -5 171 |
| Income for the period | - | - | -11 376 | -11 376 |
| Closing balance as of January 31, 2010 | 3 761 | 4 620 | 140 489 | 148 870 |
| Opening balance as of May 1, 2009 | 3 350 | 4 620 | 54 626 | 62 596 |
| New share issues | 411 | - | 102 410 | 102 821 |
| Issue expenses | - | - | -5 171 | -5 171 |
| Income for the period | - | - | -18 401 | -18 401 |
| Closing balance as of April 30, 2010 | 3 761 | 4 620 | 133 464 | 141 845 |
| 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 | - | - | -44 416 | -44 416 |
| Closing balance as of January 31, 2011 | 5 208 | 4 620 | 305 929 | 315 757 |
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 2009 – April 30 2010. The new and revised accounting standards applied by Oasmia as of May 1 2010 have not had any effect on the Oasmia financial statements.
Note 2 Taxes
The Group has accumulated losses carried forward amounting to TSEK 141 302 (91 600) and the Parent Company has similar amounting to TSEK 132 337 (83 226). 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.
| TSEK | 2011-01-31 | 2010-01-31 | 2010-04-30 |
|---|---|---|---|
| Paclical® | 127 363 | 60 559 | 76 227 |
| Paccal® Vet | 79 255 | 59 291 | 64 633 |
| Total | 206 619 | 119 849 | 140 860 |
Note 4 Transactions with related parties
Essential transactions with related parties are disclosed below.
The principal owner Oasmia S.A has provided Oasmia with a credit facility amounting to MSEK 100. Of this credit, MSEK 60 is valid until March 2011 and MSEK 40 is valid until August 2011 and is automatically renewed with 12 months if the credit is not cancelled by either party at the latest 3 months before the term expiry date. The contract interest is 6 %. In the period March – October, the company utilized parts of this credit facility continuously. Oasmia S.A used outstanding loans receivables and interest as payment for subscribed shares in the preferential rights new share issue carried out in November 2010. As of January 31, 2011 the company had no liabilities to Oasmia S.A. This was also the case as of January 31, 2010.
Oasmia's claim in the subsidiary Qdoxx Pharma AB amounted as of closing day to TSEK 37 (TSEK 405). Oasmia has in the period made a group contribution to Qdoxx Pharma AB of TSEK 290 (1 650), where TSEK 80 (1 000) in the third quarter. See also note 6.
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 Participations in group companies
Impairments of participations in the wholly owned subsidiary Qdoxx Pharma AB has been made in the period corresponding to group contributions amounting to TSEK 290 (1 650) as the reason for the group contribution was to cover losses in the subsidiary. The impairments are accounted for in the Parent company Income statement in the item Result from participations in group companies.
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 2009 – April 30 2010. No additional risks beyond those described therein have been judged significant.
Note 8 Fees to stock markets
In Stockholm, the listing fee including a one-year follow-up amounted to SEK 750 000 and the annual fee is SEK 180 000. In Frankfurt, the listing fee was EUR 3 000 and the annual fee is EUR 7 500. There is no chargeable one-year follow-up in Frankfurt.
The Board of Directors and CEO of Oasmia Pharmaceutical AB ensures that this Interim rep ort 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, March 9, 2011
Bj•rn Bj•rnsson,Chairman Claes Piehl,Member
Peter Str•m,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 trade in financial instruments. The information was deliv ered for publication on March9, 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 versio n 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 1 752 28UPPSALA, SWEDEN +46 18 50 54 40 www.oasmia.com [email protected]
Questions concerning the report are answered by: Julian Aleksov,CEO +46 18 50 54 40
UPCOMING REPORT DATES
| Year-end Report May 2010 – April 2011 | 2011-06-10 |
|---|---|
| Annual Report May 2010 – April 2011 | 2011-08-25 |
| Interim report May – July 2011 | 2011-09-08 |
| Interim report May – October 2011 | 2011-12-08 |