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Vivesto Interim / Quarterly Report 2012

Dec 6, 2012

3124_ir_2012-12-06_6d403d0d-b93c-4ded-8c86-7a8a307a6045.pdf

Interim / Quarterly Report

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Oasmia Pharmaceutical AB (publ)

Interim report for the period May - October 2012 €

THE MARKET AUTHORIZATION PROCESS FOR PACLICAL® HAS BEGUN

Page 1-8 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 eight pages of that report converted to EUR. The full official report will be found on pages 9-21. 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 October 31, 2012 which was 8.6192 SEK per one EUR. Some figures are in SEK because these are very firmly denominated in SEK.

THE PERIOD May 1 – October 31, 2012

  • Consolidated Net sales amounted to € 0 thousand (103) 1
  • Operating income amounted to € -3,627 thousand (-3,336)
  • Net income after tax amounted to € -3,932 thousand (-3,329)
  • Earnings per share amounted to € -0.07 (-0.06)
  • Comprehensive income amounted to € -3,932 thousand (-3,329)

SECOND QUARTER August 1 – October 31, 2012

  • Consolidated Net sales amounted to € 0 thousand (0)
  • Operating income amounted to € -1,501 thousand (-1,553)
  • Net income after tax amounted to € -1,690 thousand (-1,559)
  • Earnings per share amounted to € -0.03 (-0.03)
  • Comprehensive income amounted to € -1,690 thousand (-1,559)
  • Oasmia has initiated the market authorization process for Paclical® with Russia as the first country of submission.
  • Oasmia initiates collaboration with Pharmasyntez in Russia
  • The company announces fully underwritten preferential rights share issue of SEK 123 million

EVENTS AFTER CLOSING DAY

• The rights issue is completed

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 Frankfurt Stock Exchange.

BUSINESS ACTIVITIES IN THE PERIOD

HUMAN HEALTH

Paclical®

Paclical® is a novel patented formulation of the well-known substance paclitaxel which is frequently used within treatment of cancer.

Paclical® is designated as an orphan drug by EMA (EU) and FDA (USA) for the indication ovarian cancer. This status is granted for minor indications and entails seven (EU) and ten (USA) years market exclusivity respectively on the indication, when a market approval is granted.

Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer. The patient enrolment is now completed and Oasmia has initiated the application process for market authorization. The first submission was in Russia and the application was filed in September 2012.

In September 2012, Oasmia also initiated a collaboration concerning joint product development with Pharmasyntez in Russia. The company was founded in 1997 and is now one of the ten largest pharmaceutical companies in Russia. Pharmasyntez cooperates with a number of leading institutes and universities in Russia.

ANIMAL HEALTH

The product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs, especially the two major indications, mastocytoma and lymphoma which together comprises about half of all cancers in dogs.

Paccal® Vet

Paccal® Vet is a novel patented formulation of the well-known substance paclitaxel.

In June 2012, Oasmia announced that the collaboration with Orion concerning Paccal® Vet had been terminated and that Oasmia has re-acquired all rights.

Oasmia has already partners in USA, Canada and Japan for Paccal® Vet. The company is now in negotiations with licensees for all other territories, including both products Paccal® Vet and Doxophos® Vet.

Oasmia intends to complement its application to EMA (EU) for market authorization of Paccal® Vet for treatment of mastocytoma based on the concern EMA had regarding the risk/benefit-ratio. Oasmia has requested and received scientific advice from EMA concerning the design of a new study comprising 50 dogs.

Oasmia's application to the FDA (USA) for market approval of Paccal® Vet for treatment of mastocytoma in dogs is currently being processed and Oasmia is now awaiting information from the authority.

Oasmia has filed conditional market authorization applications for Paccal® Vet for treatment of both mammary tumors and squamous cell carcinoma in dogs.

All three indications have previously been granted MUMS designation by the FDA.

Doxophos® Vet

Doxophos® Vet is a novel 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 comprising 15 dogs. Initial dose have been well tolerated.

In July 2012, Doxophos® Vet was granted MUMS designation for the indication lymphoma by the FDA.

MUMS (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 has been obtained. However, safety data must prove that the product is safe.

THE COMPANY

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 and the interest rate is 5 %.

Preferential rights issue

In October 2012, the company announced a new share issue with preferential rights of MSEK 123. The share issue is completely underwritten by subscription and guarantee commitments from the two principal owners of Oasmia, Alceco International S.A. and Nexttobe AB. The issue share price was SEK 5 per new share.

EVENTS AFTER THE CLOSING DAY

Preferential rights share issue completed

In November 2012, the fully underwritten preferential rights issue was completed. It provided MSEK 123 before issue expenses. The share capital increased with SEK 2 453 170 to SEK 8 177 233. The number of shares increased with 24 531 699 to 81 772 330. The share issue lead to that Oasmia's second largest owner Nexttobe AB increased its ownership from 10.1 % to 17.4 % and that the principal owner Alceco International S.A. increased its ownership from 46.8 % to 46.9 %.

FINANCIAL INFORMATION

Consolidated Income Statement in brief

2012 2011 2012 2011 2011/12
€ thousands Aug-Oct Aug-Oct May-Oct May-Oct May-April
Net sales - - - 103 103
Capitalized development cost 2,018 1,663 3,154 3,993 7,342
Operating income -1,501 -1,553 -3,627 -3,336 -7,603
Net income after tax -1,690 -1,559 -3,932 -3,329 -7,619
Earnings per share (€), before and after dilution* -0.03 -0.03 -0.07 -0.06 -0.14
Comprehensive income for the period -1,690 -1,559 -3,932 -3,329 -7,619

*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.

The period May 1 – October 31, 2012

Net sales

Net sales amounted to € 0 thousand (103).

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. This amounted to € 3,154 thousand (3,993). The majority concerned Paclical®. However, a capitalization of Paccal® Vet amounting to € 26 thousand was also included since a study to complement the EMA filing is currently being carried out. The drop in capitalization is due to the near completion of the Paclical® Phase III study in ovarian cancer.

Operating expenses

Operating expenses excluding depreciation and impairment amounted to € 6,497 thousand (7,144). This 9 % decrease compared to the same period previous year is attributable to lower expenses for Paclical® clinical trials.

Of these operating expenses about 49 % (56), were recorded as Capitalized development cost.

The number of employees was 73 (78) at the end of the period.

Income for the period

Net income was € -3,932 thousand (-3,329). The decrease is due to zero net sales for the period, and that capitalization of operating expenses decreased more than the reduction in operating expenses and finally due to interest expenses attributable to borrowing in the current fiscal year.

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 € 234 thousand (4,838). The interest-bearing liabilities were € 12,722 thousand (0). These liabilities consisted of a € 12,182 thousand loan from Nexttobe and an unutilized bank credit of € 540 thousand.

At the end of the period, unutilized credits with bank and the principal owner Alceco International S.A amounted to TSEK 349 and TSEK 40 000 respectively. The latter credit facility was increased in October 2012 from TSEK 25 000 to TSEK 40 000.

Furthermore, Oasmia holds a SEDA agreement (Standby Equity Distribution agreement) amounting to TSEK 75 000, which was completely unutilized on October 31, 2012.

Equity at the end of the period amounted to € 27,797 thousand (36,055), the equity/assets ratio was 63 % (91) and the net debt/equity ratio was 45 % (0).

Cash flow and Capital expenditures

Cash flow from operating activities amounted to € -4,038 thousand (-2,653).

Cash flow from investing activities amounted to € -4,880 thousand (-4,202).

Investments in intangible assets amounted to € 4,383 thousand (4,011), consisting of capitalized development costs € 3,154 thousand and patents and other intangible assets € 1,229 thousand.

Investments in property, plant and equipment amounted to € 497 thousand (191) and in general concerned acquisition of production equipment placed at Baxter in Germany.

Financing

Financing during the period was performed by borrowing from Nexttobe AB. During the period, Oasmia has increased borrowing from TSEK 25 000 to TSEK 105 000. In October 2012, the entire amount of TSEK 105 000 was rewritten as one loan with a tenor ending December 31, 2013. The interest rate is still 5 % and is paid when due.

The parent company

The parent company net sales in the period amounted to € 0 thousand (103) and net income before tax amounted to € -3,934 thousand (-3,326). The parent company liquid assets at the end of the period amounted to € 233 thousand (4,836).

Second quarter August 1 – October 31, 2012

Net sales

Net sales amounted to € 0 thousand (0).

Capitalized development cost

Capitalized development cost amounted to € 2,018 thousand (1,663) and mainly concerned Paclical®, although Paccal® Vet was included with € 26 thousand. The increase compared to the same quarter previous year is attributable to increased costs for clinical trials in Phase III.

Operating expenses

Operating expenses excluding depreciation and impairment amounted to € 3,379 thousand (3,069). This increase compared to the same quarter previous year is attributable to increased expenses for Paclical® clinical trials.

Income for the quarter

Net income was € -1,690 thousand (-1,559). The decrease is attributable to interest expenses.

Key ratios and other information

2012 2011 2012 2011 2011/12
Aug-Oct Aug-Oct May-Oct May-Oct May-April
Number of shares at the close of the period (in thousands),
before and after dilution* 58,214 58,214 58,214 58,214 58,214
Weighted average number of shares (in thousands) before and after dilution* 58,214 53,022 58,214 52,993 55,589
Earnings per share in €, before and after dilution* -0.03 -0.03 -0.07 -0.06 -0.14
Equity per share, €* 0.48 0.62 0.48 0.62 0.55
Equity/Assets ratio, % 63 91 63 91 78
Net debt, € thousand 12,488 -4,838 12,488 -4,838 3,570
Net debt/Equity ratio, % 45 0 45 0 11
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 73 78 73 78 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

2012 2011 2012 2011 2011/12
€ thousands Aug-Oct Aug-Oct May-Oct May-Oct May-April
Net sales - - - 103 103
Capitalized development cost 2,018 1,663 3,154 3,993 7,342
Other operating income 8 - 11 5 12
Raw materials, consumables and goods for resale -236 -233 -448 -657 -1,175
Other external expenses -2,151 -1,859 -3,780 -4,347 -8,525
Employee benefit expenses -992 -977 -2,269 -2,140 -4,773
Depreciation/amortization and impairment -147 -147 -296 -293 -587
Other operating cost - - - - -
Operating income -1,501 -1,553 -3,627 -3,336 -7,603
Financial income 0 0 0 15 42
Financial expenses -189 -6 -305 -9 -58
Financial items, net -189 -6 -305 6 -16
Income before taxes -1,690 -1,559 -3,932 -3,329 -7,619
Taxes - - - - -
Income for the period -1,690 -1,559 -3,932 -3,329 -7,619
Income for the period attributable to:
Shareholders of the Parent company -1,690 -1,559 -3,932 -3,329 -7,619
Earnings per share
Before dilution, € -0.03 -0.03 -0.07 -0.06 -0.14
After dilution, € -0.03 -0.03 -0.07 -0.06 -0.14

Consolidated Statement of Comprehensive income

€ thousands 2012
Aug-Oct
2011
Aug-Oct
2012
May-Oct
2011
May-Oct
2011/12
May-April
Income for the period -1,690 -1,559 -3,932 -3,329 -7,619
Comprehensive income for the period -1,690 -1,559 -3,932 -3,329 -7,619
Comprehensive income for the period attributable to:
Shareholders of the Parent company -1,690 -1,559 -3,932 -3,329 -7,619
Comprehensive earnings per share
Before dilution, € -0.03 -0.03 -0.07 -0.06 -0.14
After dilution, € -0.03 -0.03 -0.07 -0.06 -0.14

Consolidated statement of financial position

€ thousands 2012-10-31 2011-10-31 2012-04-30
ASSETS
Non-current assets
Property, plant and equipment 3,268 3,111 3,015
Capitalized development cost 36,822 30,319 33,668
Other intangible assets 3,299 1,042 3,179
Financial assets 0 0 0
Total Non-current assets 43,388 34,472 39,862
Current assets
Inventories 103 34 34
Other current receivables 268 166 203
Prepaid expenses and accrued income 241 278 251
Liquid assets 234 4,838 235
Total Current assets 846 5,316 722
TOTAL ASSETS 44,235 39,788 40,585
EQUITY
Equity attributed to shareholders of the Parent Company
Share capital 664 664 664
Other capital provided 53,118 53,154 53,118
Retained earnings -25,985 -17,763 -22,053
Total Equity 27,797 36,055 31,728
LIABILITIES
Non-current liabilities
Long-term borrowings 12,182 - -
Other non-current liabilities 2,171 1,887 1,887
Total non-current liabilities 14,354 1,887 1,887
Current liabilities
Liabilities to credit institutions 540 - 371
Short-term borrowings - - 3,434
Trade payables 811 832 1,193
Other current liabilities 175 175 1,254
Accrued expenses and prepaid income 559 839 717
Total Current liabilities 2,084 1,847 6,969
Total liabilities 16,438 3,733 8,856
TOTAL EQUITY AND LIABILITIES 44,235 39,788 40,585

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 604 47,960 -14,434 34,130
Comprehensive income for the period - - -3,329 -3,329
New share issue 60 5,509 - 5,569
Issue expenses - -315 - -315
Closing balance as of October 31, 2011 664 53,154 -17,763 36,055
Opening balance as of May 1, 2011 604 47,960 -14,434 34,130
Comprehensive income for the period - - -7,619 -7,619
New share issue 60 5,509 - 5,569
Issue expenses - -351 - -351
Closing balance as of April 30, 2012 664 53,118 -22,053 31,728
Opening balance as of May 1, 2012 664 53,118 -22,053 31,728
Comprehensive income for the period - - -3,932 -3,932
Closing balance as of October 31, 2012 664 53,118 -25,985 27,797

Consolidated Cash flow statement

2012 2011 2012 2011 2011/12
€ thousands Aug-Oct Aug-Oct May-Oct May-Oct May-April
Operating activities
Operating income before financial items -1,501 -1,553 -3,627 -3,336 -7,603
Depreciation/amortization 147 147 296 293 587
Interest received 0 0 0 15 42
Interest paid -48 -6 -53 -9 -58
Cash flow from operating activities before
working capital changes -1,401 -1,412 -3,384 -3,036 -7,032
Change in working capital
Change in inventories 0 -34 -69 -34 -34
Change in other current receivables -9 -11 -56 135 126
Change in trade payables 447 247 -382 387 748
Change in other current liabilities -192 -174 -147 -106 107
Cash flow from operating activities -1,155 -1,384 -4,038 -2,653 -6,084
Investing activities
Investments in intangible fixed assets -2,148 -1,663 -4,383 -4,011 -8,490
Investments in property, plant and equipment -292 -17 -497 -191 -338
Cash flow from investing activities -2,440 -1,681 -4,880 -4,202 -8,828
Financing activities
Increase in liabilities to credit institutions 540 - 169 - 371
Increase in long-term liabilities - - - 103 103
New share issue - 5,569 - 5,569 5,569
Issue expenses - - - - -351
New loans 1,740 - 9,282 - 3,434
Repayment of loans - - -534 - -
Cash flow from financing activities 2,280 5,569 8,917 5,672 9,126
Cash flow for the period -1,316 2,504 -1 -1,183 -5,786
Cash and cash equivalents at the beginning of the period 1,550 2,333 235 6,021 6,021
Cash and cash equivalents at the end of the period 234 4,838 234 4,838 235

Oasmia Pharmaceutical AB (publ)

Interim report for the period May - October 2012

THE MARKET AUTHORIZATION PROCESS FOR PACLICAL® HAS BEGUN

THE PERIOD May 1 – October 31, 2012

  • Consolidated Net sales amounted to TSEK 0 (891) 2
  • Operating income amounted to TSEK –31 263 (-28 752)
  • Net income after tax amounted to TSEK –33 887 (-28 696)
  • Earnings per share amounted to SEK -0,58 (-0,54)
  • Comprehensive income amounted to TSEK -33 887 (-28 696)

SECOND QUARTER August 1 – October 31, 2012

  • Consolidated Net sales amounted to TSEK 0 (0)
  • Operating income amounted to TSEK –12 934 (-13 384)
  • Net income after tax amounted to TSEK –14 564 (-13 435)
  • Earnings per share amounted to SEK -0,25 (-0,25)
  • Comprehensive income amounted to TSEK -14 564 (-13 435)
  • Oasmia has initiated the market authorization process for Paclical® with Russia as the first country of submission.
  • Oasmia initiates collaboration with Pharmasyntez in Russia
  • The company announces fully underwritten preferential rights share issue of SEK 123 million

EVENTS AFTER CLOSING DAY

• The rights issue is completed

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 Frankfurt Stock Exchange.

BUSINESS ACTIVITIES IN THE PERIOD

HUMAN HEALTH

Paclical®

Paclical® is a novel patented formulation of the well-known substance paclitaxel which is frequently used within treatment of cancer.

Paclical® is designated as an orphan drug by EMA (EU) and FDA (USA) for the indication ovarian cancer. This status is granted for minor indications and entails seven (EU) and ten (USA) years market exclusivity respectively on the indication, when a market approval is granted.

Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer. The patient enrolment is now completed and Oasmia has initiated the application process for market authorization. The first submission was in Russia in September 2012.

In September 2012, Oasmia also initiated a collaboration concerning joint product development with Pharmasyntez in Russia. The company was founded in 1997 and is now one of the ten largest pharmaceutical companies in Russia. Pharmasyntez cooperates with a number of leading institutes and universities in Russia.

ANIMAL HEALTH

The product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs, especially the two major indications and mastocytoma and lymphoma which together comprises about half of all cancers in dogs.

Paccal® Vet

Paccal® Vet is a novel patented formulation of the well-known substance paclitaxel.

In June 2012, Oasmia announced that the collaboration with Orion concerning Paccal® Vet had been terminated and that Oasmia has re-acquired all rights.

Oasmia has already partners in USA, Canada and Japan for Paccal® Vet. The company is now in negotiations with licensees for all other territories, including both products Paccal® Vet and Doxophos® Vet.

Oasmia intends to complement its application to EMA (EU) for market authorization of Paccal® Vet for treatment of mastocytoma based on the concern EMA had regarding the risk/benefit-ratio. Oasmia has requested and received scientific advice from EMA concerning the design of a new study comprising 50 dogs.

Oasmia's application to the FDA (USA) for market approval of Paccal® Vet for treatment of mastocytoma in dogs is currently being processed and Oasmia is now awaiting information from the authority.

Oasmia has filed conditional market authorization applications for Paccal® Vet for treatment of both mammary tumors and squamous cell carcinoma in dogs.

All three indications have previously been granted MUMS designation by the FDA.

Doxophos® Vet

Doxophos® Vet is a novel 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 comprising 15 dogs. Initial dose have been well tolerated.

In July 2012, Doxophos® Vet was granted MUMS designation for the indication lymphoma by the FDA.

MUMS (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 has been obtained. However, safety data must prove that the product is safe.

THE COMPANY

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 and the interest rate is 5 %.

Preferential rights issue

In October 2012, the company announced a new share issue with preferential rights of MSEK 123. The share issue is completely underwritten by subscription and guarantee commitments from the two principal owners of Oasmia, Alceco International S.A. and Nexttobe AB. The issue share price was SEK 5 per new share.

EVENTS AFTER THE CLOSING DAY

Preferential rights share issue completed

In November 2012, the fully underwritten preferential rights issue was completed. It provided MSEK 123 before issue expenses. The share capital increased with SEK 2 453 170 to SEK 8 177 233. The number of shares increased with 24 531 699 to 81 772 330. The share issue lead to that Oasmia's second largest owner Nexttobe AB increased its ownership from 10.1 % to 17.4 % and that the principal owner Alceco International S.A. increased its ownership from 46.8 % to 46.9 %.

FINANCIAL INFORMATION

Consolidated Income Statement in brief

2012 2011 2012 2011 2011/12
TSEK Aug-Oct Aug-Oct May-Oct May-Oct May-April
Net sales - - - 891 891
Capitalized development cost 17 395 14 336 27 184 34 420 63 282
Operating income -12 934 -13 384 -31 263 -28 752 -65 536
Net income after tax -14 564 -13 435 -33 887 -28 696 -65 670
Earnings per share (SEK), before and after dilution * -0,25 -0,25 -0,58 -0,54 -1,18
Comprehensive income for the period -14 564 -13 435 -33 887 -28 696 -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.

The period May 1 – October 31, 2012

Net sales Net sales amounted to TSEK 0 (891).

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. This amounted to TSEK 27 184 (34 420). The majority concerned Paclical®. However, a capitalization of Paccal® Vet amounting to TSEK 226 was also included since a study to complement the EMA filing is currently being carried out. The drop in capitalization is due to the near completion of the Paclical® Phase III study in ovarian cancer.

Operating expenses

Operating expenses excluding depreciation and impairment amounted to TSEK 55 996 (61 578). This 9 % decrease compared to the same period previous year is attributable to lower expenses for Paclical® clinical trials.

Of these operating expenses about 49 % (56), were recorded as Capitalized development cost.

The number of employees was 73 (78) at the end of the period.

Income for the period

Net income was TSEK -33 887 (-28 696). The decrease is due to zero net sales for the period, and that capitalization of operating expenses decreased more than the reduction in operating expenses and finally due to interest expenses attributable to borrowing in the current fiscal year.

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 2 017 (41 696). The interest-bearing liabilities were TSEK 109 651 (0). These liabilities consisted of a TSEK 105 000 loan from Nexttobe and an unutilized bank credit of TSEK 4 651.

At the end of the period, unutilized credits with bank and the principal owner Alceco International S.A amounted to TSEK 349 and TSEK 40 000 respectively. The latter credit facility was increased in October 2012 from TSEK 25 000 to TSEK 40 000.

Furthermore, Oasmia holds a SEDA agreement (Standby Equity Distribution agreement) amounting to TSEK 75 000, which was completely unutilized on October 31, 2012.

Equity at the end of the period amounted to TSEK 239 586 (310 761), the equity/assets ratio was 63 % (91) and the net debt/equity ratio was 45 % (0).

Cash flow and Capital expenditures

Cash flow from operating activities amounted to TSEK -34 804 (-22 869).

Cash flow from investing activities amounted to TSEK -42 061 (-36 221).

Investments in intangible assets amounted to TSEK 37 780 (34 575), consisting of capitalized development costs TSEK 27 184 and patents and other intangible assets TSEK 10 597.

Investments in property, plant and equipment amounted to TSEK 4 281 (1 646) and in general concerned acquisition of production equipment placed at Baxter in Germany.

Financing

Financing during the period was performed by borrowing from Nexttobe AB. During the period, Oasmia has increased borrowing from TSEK 25 000 to TSEK 105 000. In October 2012, the entire amount of TSEK 105 000 was rewritten as one loan with a tenor ending December 31, 2013. The interest rate is still 5 % and is paid when due.

The parent company

The parent company net sales in the period amounted to TSEK 0 (891) and net income before tax amounted to TSEK -33 906 (-28 670). The parent company liquid assets at the end of the period amounted to TSEK 2 009 (41 682).

Second quarter August 1 – October 31, 2012

Net sales Net sales amounted to TSEK 0 (0).

Capitalized development cost

Capitalized development cost amounted to TSEK 17 395 (14 336) and mainly concerned Paclical®, although Paccal® Vet was included with TSEK 226. The increase compared to the same quarter previous year is attributable to increased costs for clinical trials in Phase III.

Operating expenses

Operating expenses excluding depreciation and impairment amounted to TSEK 29 124 (26 455). This increase compared to the same quarter previous year is attributable to increased expenses for Paclical® clinical trials.

Income for the quarter

Net income was TSEK -14 564 (-13 435). The decrease is attributable to interest expenses.

Key ratios and other information

2012 2011 2012 2011 2011/12
Aug-Oct Aug-Oct May-Oct May-Oct May-April
Number of shares at the close of the period (in thousands), before and after
dilution * 58 214 58 214 58 214 58 214 58 214
Weighted average number of shares (in thousands) before and after dilution* 58 214 53 022 58 214 52 993 55 589
Earnings per share in SEK, before and after dilution* -0,25 -0,25 -0,58 -0,54 -1,18
Equity per share, SEK* 4,12 5,34 4,12 5,34 4,70
Equity/Assets ratio, % 63 91 63 91 78
Net debt, TSEK 107 634 -41 696 107 634 -41 696 30 769
Net debt/Equity ratio, % 45 0 45 0 11
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 73 78 73 78 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

2012 2011 2012 2011 2011/12
TSEK Note Aug-Oct Aug-Oct May-Oct May-Oct May-April
Net sales - - - 891 891
Capitalized development cost 17 395 14 336 27 184 34 420 63 282
Other operating income 65 - 96 42 104
Raw materials, consumables and goods for resale -2 035 -2 012 -3 858 -5 663 -10 127
Other external expenses -18 542 -16 027 -32 577 -37 469 -73 481
Employee benefit expenses -8 546 -8 417 -19 560 -18 445 -41 144
Depreciation/amortization and impairment -1 270 -1 265 -2 547 -2 527 -5 062
Other operating expenses - - - - -
Operating income -12 934 -13 384 -31 263 -28 752 -65 536
Financial income 1 1 4 133 363
Financial expenses -1 631 -53 -2 628 -77 -497
Financial items, net -1 630 -51 -2 625 56 -135
Income before taxes -14 564 -13 435 -33 887 -28 696 -65 670
Taxes 2 - - - - -
Income for the period -14 564 -13 435 -33 887 -28 696 -65 670
Income for the period attributable to:
Shareholders of the Parent company -14 564 -13 435 -33 887 -28 696 -65 670
Earnings per share
Before dilution, SEK -0,25 -0,25 -0,58 -0,54 -1,18
After dilution, SEK -0,25 -0,25 -0,58 -0,54 -1,18

Consolidated Statement of Comprehensive income

2012 2011 2012 2011 2011/12
TSEK Note Aug-Oct Aug-Oct May-Oct May-Oct May-April
Income for the period -14 564 -13 435 -33 887 -28 696 -65 670
Comprehensive income for the period -14 564 -13 435 -33 887 -28 696 -65 670
Comprehensive income for the period attributable
to:
Shareholders of the Parent company -14 564 -13 435 -33 887 -28 696 -65 670
Comprehensive Earnings per share
Before dilution, SEK -0,25 -0,25 -0,58 -0,54 -1,18
After dilution, SEK -0,25 -0,25 -0,58 -0,54 -1,18

Consolidated statement of financial position

TSEK Note 2012-10-31 2011-10-31 2012-04-30
ASSETS
Non-current assets
Property, plant and equipment 28 165 26 814 25 988
Capitalized development cost 3 317 375 261 330 290 191
Other intangible assets 28 431 8 977 27 400
Financial assets 2 2 2
Total Non-current assets 373 972 297 123 343 581
Current assets
Inventories 887 290 290
Other current receivables 2 311 1 432 1 747
Prepaid expenses and accrued income 2 080 2 400 2 161
Liquid assets 2 017 41 696 2 028
Total Current assets 7 295 45 818 6 227
TOTAL ASSETS 381 267 342 941 349 807
EQUITY
Equity attributed to shareholders of the Parent Company
Share capital 5 724 5 724 5 724
Other capital provided 457 832 458 144 457 832
Retained earnings -223 969 -153 107 -190 082
Total equity 239 586 310 761 273 474
LIABILITIES
Non-current liabilities
Long-term borrowings 105 000 - -
Other non-current liabilities 18 716 16 264 16 264
Total Non-current liabilities 123 716 16 264 16 264
Current liabilities
Liabilities to credit institutions 4 651 - 3 197
Short-term borrowings 4 - - 29 600
Trade payables 6 991 7 170 10 281
Other current liabilities 1 506 1 511 10 811
Accrued expenses and prepaid income 4 817 7 234 6 180
Total Current liabilities 17 964 15 916 60 069
Total Liabilities 141 680 32 180 76 334
TOTAL EQUITY AND LIABILITIES 381 267 342 941 349 807
Contingent liabilities 5

Pledged assets 5

Consolidated statement of changes in equity

Attributable to shareholders of the Parent company
Other Retained earn
TSEK Share capital capital provided ings Total equity
Opening balance as of May 1, 2011 5 208 413 375 -124 411 294 171
Comprehensive income for the period - - -28 696 -28 696
New share issue 516 47 484 - 48 000
Issue expenses
Closing balance as of October 31, 2011
-
5 724
-2 714
458 144
-
-153 107
-2 714
310 761
Opening balance as of May 1, 2011 5 208 413 375 -124 411 294 171
Comprehensive income for the period
New share issue
-
516
-
47 484
-65 670
-
-65 670
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 period - - -33 887 -33 887
Closing balance as of October 31, 2012 5 724 457 832 -223 969 239 586
Consolidated Cash flow statement
2012 2011 2012 2011 2011/12
TSEK Aug-Oct Aug-Oct May-Oct May-Oct May-April
Operating activities
Operating income before financial items -12 934 -13 384 -31 263 -28 752 -65 536
Depreciation/amortization 1 270 1 265 2 547 2 527 5 062
Interest received 1 1 4 133 363
Interest paid -412 -53 -456 -77 -497
Cash flow from operating activities before
working capital changes
-12 075 -12 170 -29 167 -26 168 -60 609
Change in working capital
Change in inventories - -290 -597 -290 -290
Change in other current receivables -77 -95 -482 1 162 1 085
Change in trade payables 3 853 2 126 -3 291 3 339 6 450
Change in other current liabilities -1 658 -1 501 -1 266 -912 924
Cash flow from operating activities -9 957 -11 930 -34 804 -22 869 -52 439
Investing activities
Investments in intangible fixed assets -18 517 -14 336 -37 780 -34 575 -73 176
Investments in property, plant and equipment
Cash flow from investing activities
-2 516
-21 034
-149
-14 486
-4 281
-42 061
-1 646
-36 221
-2 914
-76 090
Financing activities
Increase in liabilities to credit institutions 4 651 - 1 454 - 3 197
Increase in long-term liabilities - - - 891 891
New share issue - 48 000 - 48 000 48 000
Issue expenses - - - - -3 027
New loans 15 000 - 80 000 - 29 600
Repayment of loans - - -4 600 - -
Cash flow from financing activities 19 651 48 000 76 854 48 891 78 662
Cash flow for the period
Cash and cash equivalents at the beginning of
-11 339 21 585 -11 -10 199 -49 867
the period
Cash and cash equivalents at the end of the
13 356 20 112 2 028 51 895 51 895
period 2 017 41 696 2 017 41 696 2 028

Parent Company Income statement

2012 2011 2012 2011 2011/12
TSEK Note Aug-Oct Aug-Oct May-Oct May-Oct May-April
Net sales - - - 891 891
Capitalized development cost 17 395 14 336 27 184 34 420 63 282
Other operating income 65 - 96 42 104
Raw materials, consumables and goods for resale -2 035 -2 012 -3 858 -5 663 -10 124
Other external expenses -18 513 -15 987 -32 519 -37 393 -73 323
Employee benefit expenses -8 546 -8 417 -19 560 -18 445 -41 144
Depreciation/amortization and impairment of
property, plant, equipment and intangible assets -1 266 -1 244 -2 540 -2 478 -4 987
Operating income -12 901 -13 323 -31 197 -28 626 -65 300
Result from participations in Group companies 4 -30 -100 -85 -100 -390
Other interest revenues and similar revenues 1 1 3 133 362
Interest cost and similar costs -1 631 -53 -2 628 -77 -495
Financial items, net -1 660 -151 -2 709 -44 -523
Income after financial items -14 561 -13 474 -33 906 -28 670 -65 823
Taxes 2 - - - - -
Income for the period -14 561 -13 474 -33 906 -28 670 -65 823

Parent Company Balance Sheet

TSEK Note 2012-10-31 2011-10-31 2012-04-30
ASSETS
Non-current assets
Intangible fixed assets
Capitalized development cost
Concessions, patents, licenses, trademarks and
3 317 375 261 330 290 191
similar rights 28 417 8 931 27 378
Property, plant and equipment
Equipment, tools, fixtures and fittings
22 082 25 460 24 149
Construction in progress and advance payments
for property, plant and equipment
6 082 1 355 1 839
Financial assets
Participations in group companies
110 110 110
Receivables from group companies - 6 -
Other securities held as non-current assets 1 1 1
Total Non-current assets 374 067 297 192 343 668
Current assets
Inventories
Raw materials and consumables
887 290 290
887 290 290
Current receivables
Receivables from group companies 4 - 2 55
Other current receivables 2 309 1 431 1 746
Prepaid expenses and accrued income 2 061 2 375 2 084
4 370 3 807 3 885
Cash and bank balances 2 009 41 682 2 020
Total current assets 7 267 45 779 6 195
TOTAL ASSETS 381 334 342 971 349 863
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 5 724 5 724 5 724
Statutory reserve 4 620 4 620 4 620
10 344 10 344 10 344
Non-restricted equity
Share premium reserve 457 832 458 144 457 832
Retained earnings -194 851 -129 028 -129 028
Income for the period -33 906 -28 670 -65 823
229 075 300 447 262 981
Total equity 239 419 310 791 273 325
Non-current liabilities
Long-term borrowings 105 000 - -
Other non-current liabilities 18 716 16 264 16 264
Total non-current liabilities
Current liabilities
123 716 16 264 16 264
Short term borrowings 4 - - 29 600
Trade payables 6 991 7 170 10 281
Liabilities to Credit institutions 4 651 - 3 197
Liabilities to group companies 4 235 - 205
Other current liabilities 1 506 1 511 10 811
Accrued expenses and prepaid income 4 817 7 234 6 180
Total Current liabilities 18 199 15 916 60 274
TOTAL EQUITY AND LIABILITIES 381 334 342 971 349 863
Contingent liabilities and pledged assets
Contingent liabilities 5 - - -
Pledged assets 5 8 000 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 - - -2 714 -2 714
Income for the period - - -28 670 -28 670
Closing balance as of October 31, 2011 5 724 4 620 300 447 310 791
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
Income for the period - - -33 906 -33 906
Closing balance as of October 31, 2012 5 724 4 620 229 075 239 419

Note 1 Accounting policies

This interim 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 262 155 (191 471) and the Parent Company has similar amounting to TSEK 252 653 (182 147). Of the total losses carried forward for the Group, TSEK 17 881 (17 881) are restricted for use through group contributions. This limitation will end by the 2014 tax assessment. The future tax effect of these losses carried forward has not been marked with a value and no deferred tax asset has been considered in the Balance Sheet.

Note 3 Capitalized development cost

TSEK 2012-10-31 2011-10-31 2012-04-30
Paclical® 236 098 180 278 209 140
Paccal® Vet 81 277 81 051 81 051
Total 317 375 261 330 290 191

Note 4 Transactions with related parties

On October 31, a credit facility of MSEK 40 was provided to Oasmia by the principal owner of the company, Alceco International SA. The interest rate on utilized credits is 5 %. As of October 31, 2012, this credit was completely unutilized (also as of October 31, 2011). Oasmia has made a TSEK 85 (100) group contribution to Oasmia Global Supplies AB in the period where TSEK 30 (100) were provided in the second quarter. Impairment of shares in the subsidiary amounting to TSEK 85 (100) have been made in the period corresponding to the group contributions, as the purpose of the group contributions was to cover losses in the subsidiary. The impairment is accounted for in the Parent company income statement in the item Result from participation 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 CEO of Oasmia Pharmaceutical AB ensures that this Interim report gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group face.

Uppsala, December 6, 2012

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 Interim 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 December 6, 2012 at 08.30.

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.

Review Report

To the Board of Directors of Oasmia Pharmaceutical AB, corp id 556332-6676

Introduction

We reviewed the accompanying condensed balance sheet of Oasmia Pharmaceutical AB as of October 31, 2012 and the related condensed summary of income, changes in equity and cash-flows for the six-month period then ended. The Board of Directors and the Managing Director are responsible for the preparation and fair presentation of this condensed interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this condensed interim financial information based on our review.

Scope of Review

We conducted our review in accordance with the Standard on Review Engagements, SÖG 2410, "Review of Interim Financial Statements Performed by the Independent Auditor of the Entity", issued by the Swedish Federation of Authorized Public Accountants. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the accompanying condensed interim financial information does not give a true and fair view of the financial position of the entity as at October 31, 2012, and its financial performance and its cash flows for the six-month period then ended, for the group in accordance with IAS 34 and the Swedish Annual Accounts Act and for the parent company in accordance with the Swedish Annual Accounts Act.

Uppsala December 6, 2012

Ernst & Young AB

Björn Ohlsson Authorized Public Accountant

COMPANY INFORMATION

Oasmia Pharmaceutical AB (publ) VAT number:SE556332-667601 Domicile: Stockholm

Address and telephone number to the Main Office Vallongatan 1 752 28 UPPSALA, 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

Interim report May 2012 – January 2013 2013-03-01
Year-end report May 2012 – April 2013 2013-06-07
Annual Report May 2012 – April 2013 2013-08-22
Interim report May 2013 – July 2013 2013-09-06