AI assistant
Vivesto — Interim / Quarterly Report 2012
Sep 6, 2012
3124_10-q_2012-09-06_befc21bb-ca4c-4d57-a365-2a6fc7206424.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2012 €
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 9-20. 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 July 31, 2012 which was 8.346 SEK per one EUR. Some figures are in SEK because these are very firmly denominated in SEK.
MUMS DESIGNATION FOR DOXOPHOS® VET
FIRST QUARTER May 1 – July 31, 2012
- Consolidated Net sales amounted to € 0 thousand (107) 1
- Operating income amounted to € -2,196 thousand (-1,841)
- Net income after tax amounted to € -2,315 thousand (-1,828)
- Earnings per share amounted to € -0.04 (-0.04)
- Comprehensive income amounted to € -2,315 thousand (-1,828)
- FDA grants MUMS designation for Doxophos® Vet
- Oasmia submits application to the FDA for conditional approval of Paccal® Vet for treatment of mammary tumors in dogs.
- Oasmia submits application to the FDA for conditional approval of Paccal® Vet for treatment of squamous cell carcinoma in dogs
- Oasmia and Orion terminate the collaboration for Paccal® Vet.
- Nexttobe AB extends its commitment in Oasmia through a MSEK 65 loan
EVENTS AFTER CLOSING DAY
• Oasmia has initiated the application process for market approval of Paclical®
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at Frankfurt Stock Exchange.
1 The numbers in parentheses concerns results for the corresponding period previous year
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.
The Phase III study with Paclical® for the treatment of ovarian cancer reached an enrolment of 650 patients in September 2011. Based on this, Oasmia has since then compiled applications of market authorizations to pharmaceutical authorities.
Paclical® is designated as an orphan drug EMA (EU) and FDA (USA) for the indication ovarian cancer. Such 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.
ANIMAL HEALTH
The company product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs and especially the two major indications lymphoma and mastocytoma 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. In connection to this, Oasmia paid Orion EUR 2 million as a re-purchase of all rights.
Oasmia has partners in USA, Canada and Japan for Paccal® Vet. The company is now in negotiations with licensees for all other territories. These include both products Paccal® Vet and Doxophos® Vet.
In March 2012, Oasmia reported that the company intends to complement its EU application of Paccal® Vet for treatment of mastocytoma in dogs. Oasmia considers the concern EMA had regarding the risk/benefit-ratio and has consequently requested and received scientific advice from EMA for clarification of certain points.
Oasmia's application to the FDA 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.
The Phase III study that was made with Paccal® Vet for the treatment of mastocytoma has enabled progress within other indications.
Oasmia has in the quarter submitted an application to the FDA for conditional approval of Paccal® Vet for treatment of mammary carcinoma in dogs.
Oasmia has in the quarter submitted an application to the FDA for conditional approval of Paccal® Vet for treatment of squamous cell carcinoma in dogs.
All three indications, for which an application has been submitted, 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 expands its commitment to Oasmia through a MSEK 65 loan.
In May 2012 Nexttobe AB expanded its commitment in Oasmia through an additional loan of MSEK 65. The interest rate is 5 %. Nexttobe is the second largest shareholder and Oasmia had a previous loan of MSEK 25 which makes the total borrowing from Nexttobe to Oasmia MSEK 90.
EVENTS AFTER THE CLOSING DAY
Oasmia has initiated the application process for market approval of Paclical® On September 5, the day before this report, Oasmia initiated the application process for market approval of Paclical®. The first country is Russia.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2012 | 2011 | 2011/12 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Net sales | - | 107 | 107 |
| Capitalized development cost | 1,173 | 2,406 | 7,582 |
| Operating income | -2,196 | -1,841 | -7,852 |
| Net income after tax | -2,315 | -1,828 | -7,868 |
| Earnings per share (€), before and after dilution | -0.04 | -0.04 | -0.14 |
| Comprehensive income for the period | -2,315 | -1,828 | -7,868 |
Net sales
Net sales amounted to € 0 thousand (107).
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 € 1,173 thousand (2,406) and concerned Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to € 3,220 thousand (4,208). This 23 % decrease is attributable to lower expenses for Paclical® clinical trials.
Of these operating expenses about 36 % (57), concerned the product candidates in Phase III which were capitalized as Capitalized development cost. The share of capitalized operating expenses is decreasing successively, which has a negative effect on the company income.
The number of employees was 76 (70) at the end of the quarter.
Income for the period
Net income was € -2,315 thousand (-1,828). The decrease is due to zero net sales for the quarter and that capitalization of operating expenses decreased more than the reduction in 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 quarter amounted to € 1,600 thousand (2,410). Equity at the same time amounted to € 30,452 thousand (33,418), the equity/assets ratio was 68 % (91) and the debt/equity ratio 30 % (0).
Oasmia has raised loans from Nexttobe amounting to TSEK 90 000. Additionally the company had available credits amounting to TSEK 30 000, where nothing had been utilized as per July 31. Furthermore, Oasmia has an unutilized SEDA-agreement (standby equity distribution agreement) amounting to TSEK 75 000, which was completely unutilized on July 31.
Cash flow and Capital expenditures
Cash flow from operating activities amounted to € -2,977 thousand (-1,311).
Cash flow from investing activities amounted to € -2,520 thousand (-2,604).
Investments in intangible assets amounted to € 2,308 thousand (2,425), consisting of capitalized development costs € 1,173 thousand and patents and other intangible assets € 1,135 thousand.
Investments in property, plant and equipment amounted to € 211 thousand (179) and concerned production equipment.
Financing
Financing in the period was performed by a new loan from Nexttobe amounting to TSEK 65 000.
The parent company
The parent company net sales in the period amounted to € 0 thousand (107) and net income before tax amounted to € -2,318 thousand (-1,821). The parent company liquid assets at the end of the quarter amounted to € 1,599 thousand (2,408).
Key ratios and other information
| 2012 | 2011 | 2011/12 | |
|---|---|---|---|
| May-July | May-July | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution | 57,241 | 52,079 | 57,241 |
| Weighted average number of shares (in thousands) before and after dilution | 57,241 | 52,079 | 54,660 |
| Earnings per share in €, before and after dilution | -0.04 | -0.04 | -0.14 |
| Equity per share, € | 0.53 | 0.64 | 0.57 |
| Equity/Assets ratio, % | 68 | 91 | 78 |
| Net debt, € thousand | 9,183 | -2,410 | 3,687 |
| Net debt/Equity ratio, % | 30 | - | 11 |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 76 | 70 | 77 |
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 | 2011/12 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Net sales | - | 107 | 107 |
| Capitalized development cost | 1,173 | 2,406 | 7,582 |
| Other operating income | 4 | 5 | 12 |
| Raw materials, consumables and goods for resale | -218 | -438 | -1,213 |
| Other external expenses | -1,682 | -2,569 | -8,804 |
| Employee benefit expenses | -1,320 | -1,202 | -4,930 |
| Depreciation/amortization and impairment | -153 | -151 | -606 |
| Operating income | -2,196 | -1,841 | -7,852 |
| Financial income | 0 | 16 | 43 |
| Financial expenses | -119 | -3 | -60 |
| Financial items, net | -119 | 13 | -16 |
| Income before taxes | -2,315 | -1,828 | -7,868 |
| Taxes | - | - | - |
| Income for the period | -2,315 | -1,828 | -7,868 |
| Income for the period attributable to: | |||
| Shareholders of the Parent company | -2,315 | -1,828 | -7,868 |
| Earnings per share | |||
| Before dilution, € | -0.04 | -0.04 | -0.14 |
| After dilution, € | -0.04 | -0.04 | -0.14 |
Consolidated Statement of Comprehensive income
| 2012 | 2011 | 2011/12 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Income for the period | -2,315 | -1,828 | -7,868 |
| Comprehensive income for the period | -2,315 | -1,828 | -7,868 |
| Comprehensive income for the period attributable to: | |||
| Shareholders of the Parent company | -2,315 | -1,828 | -7,868 |
| Comprehensive Earnings per share | |||
| Before dilution, € | -0.04 | -0.04 | -0.14 |
| After dilution, € | -0.04 | -0.04 | -0.14 |
Consolidated statement of financial position
| € thousands | 2012-07-31 | 2011-07-31 | 2012-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 3,198 | 3,320 | 3,114 |
| Capitalized development cost | 35,943 | 29,594 | 34,770 |
| Other intangible assets | 3,299 | 1,102 | 3,283 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 42,440 | 34,017 | 41,167 |
| Current assets | |||
| Inventories | 106 | - | 35 |
| Other current receivables | 200 | 154 | 209 |
| Prepaid expenses and accrued income | 317 | 293 | 259 |
| Liquid assets | 1,600 | 2,410 | 243 |
| Total Current assets | 2,223 | 2,857 | 746 |
| TOTAL ASSETS | 44,664 | 36,874 | 41,913 |
| EQUITY | |||
| Equity attributed to shareholders of the Parent Company | |||
| Share capital | 686 | 624 | 686 |
| Other capital provided | 54,856 | 49,530 | 54,856 |
| Retained earnings | -25,090 | -16,735 | -22,775 |
| Total equity | 30,452 | 33,418 | 32,767 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 1,949 | 1,949 | 1,949 |
| Total Non-current liabilities | 1,949 | 1,949 | 1,949 |
| Current liabilities | |||
| Liabilities to credit institutions | - | - | 383 |
| Short-term borrowings | 10,784 | - | 3,547 |
| Trade payables | 376 | 604 | 1,232 |
| Other current liabilities | 187 | 159 | 1,295 |
| Accrued expenses and prepaid income | 917 | 744 | 740 |
| Total Current liabilities | 12,263 | 1,507 | 7,197 |
| Total Liabilities | 14,212 | 3,456 | 9,146 |
| TOTAL EQUITY AND LIABILITIES | 44,664 | 36,874 | 41,913 |
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 | 624 | 49,530 | -14,907 | 35,247 |
| Comprehensive income for the period | - | - | -1,828 | -1,828 |
| Closing balance as of July 31, 2011 | 624 | 49,530 | -16,735 | 33,418 |
| Opening balance as of May 1, 2011 | 624 | 49,530 | -14,907 | 35,247 |
| Comprehensive income for the period | - | - | -7,868 | -7,868 |
| New share issue | 62 | 5,689 | - | 5,751 |
| Issue expenses | - | -363 | - | -363 |
| Closing balance as of April 30, 2012 | 686 | 54,856 | -22,775 | 32,767 |
| Opening balance as of May 1, 2012 | 686 | 54,856 | -22,775 | 32,767 |
| Comprehensive income for the period | - | - | -2,315 | -2,315 |
| Closing balance as of July 31, 2012 | 686 | 54,856 | -25,090 | 30,452 |
Consolidated Cash flow statement
| 2012 | 2011 | 2011/12 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Operating activities | |||
| Operating income before financial items | -2,196 | -1,841 | -7,852 |
| Depreciation/amortization | 153 | 151 | 606 |
| Interest received | 0 | 16 | 43 |
| Interest paid | -119 | -3 | -60 |
| Cash flow from operating activities before | |||
| working capital changes | -2,162 | -1,677 | -7,262 |
| Change in working capital | |||
| Change in inventories | -72 | - | -35 |
| Change in other current receivables | -49 | 151 | 130 |
| Change in trade payables | -856 | 145 | 773 |
| Change in other current liabilities | 161 | 71 | 111 |
| Cash flow from operating activities | -2,977 | -1,311 | -6,283 |
| Investing activities | |||
| Investments in intangible fixed assets | -2,308 | -2,425 | -8,768 |
| Investments in property, plant and equipment | -211 | -179 | -349 |
| Cash flow from investing activities | -2,520 | -2,604 | -9,117 |
| Financing activities | |||
| Increase in liabilities to credit institutions | - | - | 383 |
| Decrease in liabilities to credit institutions | -383 | - | - |
| Increase in long-term liabilities | - | 107 | 107 |
| New share issue | - | - | 5,751 |
| Issue expenses | - | - | -363 |
| New loans | 7,788 | - | 3,547 |
| Repayment of loans | -551 | - | - |
| Cash flow from financing activities | 6,854 | 107 | 9,425 |
| Cash flow for the period | 1,357 | -3,808 | -5,975 |
| Cash and cash equivalents at the beginning of the period | 243 | 6,218 | 6,218 |
| Cash and cash equivalents at the end of the period | 1,600 | 2,410 | 243 |
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2012
MUMS DESIGNATION FOR DOXOPHOS® VET
FIRST QUARTER May 1 – July 31, 2012
- Consolidated Net sales amounted to TSEK 0 (891) 2
- Operating income amounted to TSEK 18 329 (-15 368)
- Net income after tax amounted to TSEK 19 323 (-15 260)
- Earnings per share amounted to SEK -0,34 (-0,29)
- Comprehensive income amounted to TSEK -19 323 (-15 260)
- FDA grants MUMS designation for Doxophos® Vet
- Oasmia submits application to the FDA for conditional approval of Paccal® Vet for treatment of mammary tumors in dogs.
- Oasmia submits application to the FDA for conditional approval of Paccal® Vet for treatment of squamous cell carcinoma in dogs
- Oasmia and Orion terminate the collaboration for Paccal® Vet.
- Nexttobe AB extends its commitment in Oasmia through a MSEK 65 loan
EVENTS AFTER CLOSING DAY
• Oasmia has initiated the application process for market approval of Paclical®
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at Frankfurt Stock Exchange.
2 The numbers in parentheses concerns results for the corresponding period previous year
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.
The Phase III study with Paclical® for the treatment of ovarian cancer reached an enrolment of 650 patients in September 2011. Based on this, Oasmia has since then compiled applications of market authorizations to pharmaceutical authorities.
Paclical® is designated as an orphan drug by EMA (EU) and FDA (USA) for the indication ovarian cancer. Such 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.
ANIMAL HEALTH
The company product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs and especially the two major indications lymphoma and mastocytoma 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. In connection to this, Oasmia paid Orion EUR 2 million as a re-purchase of all rights.
Oasmia has partners in USA, Canada and Japan for Paccal® Vet. The company is now in negotiations with licensees for all other territories. These include both products Paccal® Vet and Doxophos® Vet.
In March 2012, Oasmia reported that the company intends to complement its EU application of Paccal® Vet for treatment of mastocytoma in dogs. Oasmia considers the concern EMA had regarding the risk/benefit-ratio and has consequently requested and received scientific advice from EMA for clarification of certain points.
Oasmia's application to the FDA 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.
The Phase III study that was made with Paccal® Vet for the treatment of mastocytoma has enabled progress within other indications.
Oasmia has in the quarter submitted an application to the FDA for conditional approval of Paccal® Vet for treatment of mammary carcinoma in dogs.
Oasmia has in the quarter submitted an application to the FDA for conditional approval of Paccal® Vet for treatment of squamous cell carcinoma in dogs.
All three indications, for which an application has been submitted, 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 expands its commitment to Oasmia through a MSEK 65 loan.
In May 2012 Nexttobe AB expanded its commitment in Oasmia through an additional loan of MSEK 65. The interest rate is 5 %. Nexttobe is the second largest shareholder and Oasmia had a previous loan of MSEK 25 which makes the total borrowing from Nexttobe to Oasmia MSEK 90.
EVENTS AFTER THE CLOSING DAY
Oasmia has initiated the application process for market approval of Paclical® On September 5, the day before this report, Oasmia initiated the application process for market approval of Paclical®. The first country is Russia.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2012 | 2011 | 2011/12 | |
|---|---|---|---|
| TSEK | May-July | May-July | May-April |
| Net sales | - | 891 | 891 |
| Capitalized development cost | 9 789 | 20 084 | 63 282 |
| Operating income | -18 329 | -15 368 | -65 536 |
| Net income after tax | -19 323 | -15 260 | -65 670 |
| Earnings per share (SEK), before and after dilution | -0,34 | -0,29 | -1,20 |
| Comprehensive income for the period | -19 323 | -15 260 | -65 670 |
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 9 789 (20 084) and concerned Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to TSEK 26 872 (35 123). This 23 % decrease is attributable to lower expenses for Paclical® clinical trials.
Of these operating expenses about 36 % (57), concerned the product candidates in Phase III which were capitalized as Capitalized development cost. The share of capitalized operating expenses is decreasing successively, which has a negative effect on the company income.
The number of employees was 76 (70) at the end of the quarter.
Income for the period
Net income was TSEK -19 323 (-15 260). The decrease is due to zero net sales for the quarter and that capitalization of operating expenses decreased more than the reduction in 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 quarter amounted to TSEK 13 356 (20 112). Equity at the same time amounted to TSEK 254 150 (278 911), the equity/assets ratio was 68 % (91) and the debt/equity ratio 30 % (0).
Oasmia has raised loans from Nexttobe amounting to TSEK 90 000. Additionally the company had available credits amounting to TSEK 30 000, where nothing had been utilized as per July 31. Furthermore, Oasmia has an unutilized SEDA-agreement (standby equity distribution agreement) amounting to TSEK 75 000, which was completely unutilized on July 31.
Cash flow and Capital expenditures Cash flow from operating activities amounted to TSEK -24 847 (-10 940).
Cash flow from investing activities amounted to TSEK -21 028 (-21 735).
Investments in intangible assets amounted to TSEK 19 263 (20 239), consisting of capitalized development costs TSEK 9 789 and patents and other intangible assets TSEK 9 474.
Investments in property, plant and equipment amounted to TSEK 1 765 (1 496) and concerned production equipment.
Financing
Financing in the period was performed by a new loan from Nexttobe amounting to TSEK 65 000.
The parent company
The parent company net sales in the period amounted to TSEK 0 (891) and net income before tax amounted to TSEK -19 345 (-15 196). The parent company liquid assets at the end of the quarter amounted to TSEK 13 348 (20 096).
Key ratios and other information
| 2012 | 2011 | 2011/12 | |
|---|---|---|---|
| May-July | May-July | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution | 57 241 | 52 079 | 57 241 |
| Weighted average number of shares (in thousands) before and after dilution | 57 241 | 52 079 | 54 660 |
| Earnings per share in SEK, before and after dilution | -0,34 | -0,29 | -1,20 |
| Equity per share, SEK | 4,44 | 5,36 | 4,78 |
| Equity/Assets ratio, % | 68 | 91 | 78 |
| Net debt, TSEK | 76 644 | -20 112 | 30 769 |
| Net debt/Equity ratio, % | 30 | - | 11 |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 76 | 70 | 77 |
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 | 2011/12 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Net sales | - | 891 | 891 | |
| Capitalized development cost | 9 789 | 20 084 | 63 282 | |
| Other operating income | 31 | 42 | 104 | |
| Raw materials, consumables and goods for resale | -1 823 | -3 652 | -10 127 | |
| Other external expenses | -14 035 | -21 442 | -73 481 | |
| Employee benefit expenses | -11 014 | -10 028 | -41 144 | |
| Depreciation/amortization and impairment | -1 278 | -1 262 | -5 062 | |
| Operating income | -18 329 | -15 368 | -65 536 | |
| Financial income | 2 | 132 | 363 | |
| Financial expenses | -997 | -24 | -497 | |
| Financial items, net | -995 | 107 | -135 | |
| Income before taxes | -19 323 | -15 260 | -65 670 | |
| Taxes | 2 | - | - | - |
| Income for the period | -19 323 | -15 260 | -65 670 | |
| Income for the period attributable to: | ||||
| Shareholders of the Parent company | -19 323 | -15 260 | -65 670 | |
| Earnings per share | ||||
| Before dilution, SEK | -0,34 | -0,29 | -1,20 | |
| After dilution, SEK | -0,34 | -0,29 | -1,20 |
Consolidated Statement of Comprehensive income
| 2012 | 2011 | 2011/12 | ||
|---|---|---|---|---|
| TSEK | Note | Mat-July | May-July | May-April |
| Income for the period | -19 323 | -15 260 | -65 670 | |
| Comprehensive income for the period | -19 323 | -15 260 | -65 670 | |
| Comprehensive income for the period attributable to: | ||||
| Shareholders of the Parent company | -19 323 | -15 260 | -65 670 | |
| Comprehensive Earnings per share | ||||
| Before dilution, SEK | -0,34 | -0,29 | -1,20 | |
| After dilution, SEK | -0,34 | -0,29 | -1,20 |
Consolidated statement of financial position
| TSEK | Note | 2012-07-31 | 2011-07-31 | 2012-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 26 694 | 27 706 | 25 988 | |
| Capitalized development cost | 3 | 299 980 | 246 993 | 290 191 |
| Other intangible assets | 27 533 | 9 201 | 27 400 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 354 208 | 283 903 | 343 581 | |
| Current assets | ||||
| Inventories | 887 | - | 290 | |
| Other current receivables | 1 666 | 1 289 | 1 747 | |
| Prepaid expenses and accrued income | 2 648 | 2 448 | 2 161 | |
| Liquid assets | 13 356 | 20 112 | 2 028 | |
| Total Current assets | 18 557 | 23 849 | 6 227 | |
| TOTAL ASSETS | 372 765 | 307 751 | 349 807 | |
| EQUITY | ||||
| Equity attributed to shareholders of the Parent Company | ||||
| Share capital | 5 724 | 5 208 | 5 724 | |
| Other capital provided | 457 832 | 413 375 | 457 832 | |
| Retained earnings | -209 405 | -139 672 | -190 082 | |
| Total equity | 254 150 | 278 911 | 273 474 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 16 264 | 16 264 | 16 264 | |
| Total Non-current liabilities | 16 264 | 16 264 | 16 264 | |
| Current liabilities | ||||
| Liabilities to credit institutions | - | - | 3 197 | |
| Short-term borrowings | 90 000 | - | 29 600 | |
| Trade payables | 3 138 | 5 044 | 10 281 | |
| Other current liabilities | 1 559 | 1 325 | 10 811 | |
| Accrued expenses and prepaid income | 7 654 | 6 207 | 6 180 | |
| Total Current liabilities | 102 351 | 12 576 | 60 069 | |
| Total Liabilities | 118 615 | 28 841 | 76 334 | |
| TOTAL EQUITY AND LIABILITIES | 372 765 | 307 751 | 349 807 | |
| Contingent liabilities | 5 | |||
| Pledged assets | 5 |
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | ||||
|---|---|---|---|---|
| Other | ||||
| TSEK | Share capital | capital provided | Retained earnings | Total equity |
| Opening balance as of May 1, 2011 | 5 208 | 413 375 | -124 411 | 294 171 |
| Comprehensive income for the period | - | - | -15 260 | -15 260 |
| Closing balance as of July 31, 2011 | 5 208 | 413 375 | -139 672 | 278 911 |
| Opening balance as of May 1, 2011 | 5 208 | 413 375 | -124 411 | 294 171 |
| Comprehensive income for the period | - | - | -65 670 | -65 670 |
| New share issue | 516 | 47 484 | - | 48 000 |
| Issue expenses | - | -3 027 | - | -3 027 |
| Closing balance as of April 30, 2012 | 5 724 | 457 832 | -190 082 | 273 474 |
| Opening balance as of May 1, 2012 | 5 724 | 457 832 | -190 082 | 273 474 |
| Comprehensive income for the period | - | - | -19 323 | -19 323 |
| Closing balance as of July 31, 2012 | 5 724 | 457 832 | -209 405 | 254 150 |
Consolidated Cash flow statement
| 2012 | 2011 | 2011/12 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Operating activities | ||||
| Operating income before financial items | -18 329 | -15 368 | -65 536 | |
| Depreciation/amortization | 1 278 | 1 262 | 5 062 | |
| Interest received | 2 | 132 | 363 | |
| Interest paid | -997 | -24 | -497 | |
| Cash flow from operating activities before | ||||
| working capital changes | -18 046 | -13 998 | -60 609 | |
| Change in working capital | ||||
| Change in inventories | -597 | - | -290 | |
| Change in other current receivables | -405 | 1 257 | 1 085 | |
| Change in trade payables | -7 144 | 1 213 | 6 450 | |
| Change in other current liabilities | 1 345 | 589 | 924 | |
| Cash flow from operating activities | -24 847 | -10 940 | -52 439 | |
| Investing activities | ||||
| Investments in intangible fixed assets | -19 263 | -20 239 | -73 176 | |
| Investments in property, plant and equipment | -1 765 | -1 496 | -2 914 | |
| Cash flow from investing activities | -21 028 | -21 735 | -76 090 | |
| Financing activities | ||||
| Increase in liabilities to credit institutions | - | - | 3 197 | |
| Decrease in liabilities to credit institutions | -3 197 | - | - | |
| Increase in long-term liabilities | - | 891 | 891 | |
| New share issue | - | - | 48 000 | |
| Issue expenses | - | - | -3 027 | |
| New loans | 65 000 | - | 29 600 | |
| Repayment of loans | 4 | -4 600 | - | - |
| Cash flow from financing activities | 57 203 | 891 | 78 662 | |
| Cash flow for the period | 11 328 | -31 784 | -49 867 | |
| Cash and cash equivalents at the beginning of the period | 2 028 | 51 895 | 51 895 | |
| Cash and cash equivalents at the end of the period | 13 356 | 20 112 | 2 028 |
Parent Company Income statement
| 2012 | 2011 | 2011/12 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Net sales | - | 891 | 891 | |
| Capitalized development cost | 9 789 | 20 084 | 63 282 | |
| Other operating income | 31 | 42 | 104 | |
| Raw materials, consumables and goods for resale | -1 823 | -3 652 | -10 124 | |
| Other external expenses | -14 006 | -21 406 | -73 323 | |
| Employee benefit expenses | -11 014 | -10 028 | -41 144 | |
| Depreciation/amortization and impairment of property, plant, | ||||
| equipment and intangible assets | -1 274 | -1 234 | -4 987 | |
| Operating income | -18 296 | -15 303 | -65 300 | |
| Result from participations in Group companies | 4 | -55 | - | -390 |
| Other interest revenues and similar revenues | 2 | 131 | 362 | |
| Interest cost and similar costs | -997 | -24 | -495 | |
| Financial items, net | -1 049 | 107 | -523 | |
| Income after financial items | -19 345 | -15 196 | -65 823 | |
| Taxes | 2 | - | - | - |
| Income for the period | -19 345 | -15 196 | -65 823 |
Parent Company Balance Sheet
| TSEK | Note | 2012-07-31 | 2011-07-31 | 2012-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 299 980 | 246 993 | 290 191 |
| similar rights Property, plant and equipment |
27 515 | 9 134 | 27 378 | |
| Equipment, tools, fixtures and fittings Construction in progress and advance payments |
23 100 | 26 352 | 24 149 | |
| for property, plant and equipment | 3 594 | 1 355 | 1 839 | |
| Financial assets Participations in group companies |
110 | 110 | 110 | |
| Receivables from group companies | - | 5 | - | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 354 299 | 283 949 | 343 668 | |
| Current assets Inventories |
||||
| Raw materials and consumables | 887 | - | 290 | |
| 887 | 0 | 290 | ||
| Current receivables | ||||
| Receivables from group companies | 4 | - | 102 | 55 |
| Other current receivables | 1 665 | 1 288 | 1 746 | |
| Prepaid expenses and accrued income | 2 600 | 2 385 | 2 084 | |
| 4 265 | 3 775 | 3 885 | ||
| Cash and bank balances | 13 348 | 20 096 | 2 020 | |
| Total current assets | 18 500 | 23 870 | 6 195 | |
| TOTAL ASSETS | 372 800 | 307 820 | 349 863 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 5 724 | 5 208 | 5 724 | |
| Statutory reserve | 4 620 | 4 620 | 4 620 | |
| 10 344 | 9 828 | 10 344 | ||
| Non-restricted equity | ||||
| Share premium reserve | 457 832 | 413 375 | 457 832 | |
| Retained earnings | -194 851 | -129 028 | -129 028 | |
| Income for the period | -19 345 | -15 196 | -65 823 | |
| 243 636 | 269 151 | 262 981 | ||
| Total equity | 253 980 | 278 979 | 273 325 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 16 264 | 16 264 | 16 264 | |
| Total non-current liabilities | 16 264 | 16 264 | 16 264 | |
| Current liabilities | ||||
| Short term borrowings | 90 000 | - | 29 600 | |
| Trade payables | 3 138 | 5 044 | 10 281 | |
| Liabilities to Credit institutions | - | - | 3 197 | |
| Liabilities to group companies | 4 | 205 | - | 205 |
| Other current liabilities | 1 559 | 1 325 | 10 811 | |
| Accrued expenses and prepaid income | 7 654 | 6 207 | 6 180 | |
| Total Current liabilities | 102 555 | 12 576 | 60 274 | |
| TOTAL EQUITY AND LIABILITIES | 372 800 | 307 820 | 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 | ||||
|---|---|---|---|---|
| Statutory | Non-restricted | |||
| TSEK | Share capital | reserve | equity | Total equity |
| Opening balance as of May 1, 2011 | 5 208 | 4 620 | 284 347 | 294 175 |
| Income for the period | - | - | -15 196 | -15 196 |
| Closing balance as of July 31, 2011 | 5 208 | 4 620 | 269 151 | 278 979 |
| 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 | - | - | -19 345 | -19 345 |
| Closing balance as of July 31, 2012 | 5 724 | 4 620 | 243 636 | 253 980 |
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 247 623 (178 054) and the Parent Company has similar amounting to TSEK 238 154 (168 791). 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 | 2012-07-31 | 2011-07-31 | 2012-04-30 | |
|---|---|---|---|---|
| Paclical® | 218 929 | 165 942 | 209 140 | |
| Paccal® Vet | 81 051 | 81 051 | 81 051 | |
| Total | 299 980 | 246 993 | 290 191 |
Note 3 Capitalized development cost
Note 4 Transactions with related parties
On July 31, a credit facility of MSEK 25 was provided to Oasmia by the principal owner of the company, Alceco International SA. The interest rate on utilized credits is 5 %. As of July 31, 2012, this credit was completely unutilized (also as of July 31, 2011).
Oasmia has made a TSEK 55 (-) group contribution to Oasmia Global Supplies AB in the period. Impairment of shares in the subsidiary amounting to TSEK 55 (-) have been made in the period corresponding to the group contributions, as the purpose of the group contributions was to cover losses in the subsidiaries. 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 Comp any and the companies that are part of the Group face.
Uppsala,September 6,2012
Joel Citron, Chairman Martin Nicklasson,Member
Jan Lundberg,Member Prof. Dr.Horst Domdey,Member
Bo Cederstrand, Member Julian Aleksov,Memberand Chief ExecutiveOfficer
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 September 6, 2012 at 09.00.
This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.
This report has not been reviewed by the company auditors.
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: Weine Nejdemo,CFO +46 18 50 54 40
UPCOMING REPORT DATES
| Interim report May – October 2012 | 2012-12-06 |
|---|---|
| Interim report May 2012 – January 2013 | 2013-03-07 |
| Year-end report May 2012 – April 2013 | 2013-06-11 |
| Annual report May 2012 – April 2013 | 2013-08-22 |