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Vivesto — Interim / Quarterly Report 2012
Jun 14, 2012
3124_10-k_2012-06-14_a301b6d7-3486-4f06-94de-d6ab4971f274.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Year-end report
for the fiscal year May 2011- April 2012 €
Page 1-9 is a service to shareholders in the euro zone. It is not the official report in the functional currency of Oasmia, which is SEK, but the first nine pages of that report converted to EUR. The full official report will be found on pages 10-23. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per April 30, 2012 which was 8.9004 SEK per one EUR. Some figures are in SEK because these are very firmly denominated in SEK.
THE FISCAL YEAR May 1, 2011 – April 30, 2012
- Consolidated Net sales amounted to € 100 thousand (12) 1
- Operating income amounted to € -7,363 thousand (-7,230)
- Net income after tax amounted to € -7,378 thousand (-7,411)
- Earnings per share amounted to € -0,13 (-0,17)
- Comprehensive income amounted to € -7,378 thousand (-7,411)
THE FOURTH QUARTER February 1 – April 30, 2012
- Consolidated Net sales amounted to € 0 thousand (0)
- Operating income amounted to € -2,182 thousand (-2,445)
- Net income after tax amounted to € -2,218 thousand (-2,417)
- Earnings per share amounted to € -0,04 (-0,05)
- Comprehensive income amounted to € -2,218 thousand (-2,417)
- Oasmia intends to complement the application for market approval with the EMA by performing a new smaller study.
EVENTS AFTER CLOSING DAY
- Oasmia and Orion jointly end Paccal® Vet agreement. Oasmia is finalizing an agreement with another party
- Nexttobe AB expands commitment to Oasmia through a MSEK 65 loan.
1 The numbers in parentheses concerns results for the corresponding period previous year
BUSINESS ACTIVITIES IN THE YEAR
PRODUCT DEVELOPMENT
Oasmia's product candidates are in varying stages of pre-clinical and clinical development. Two of them are in late final clinical phase and Oasmia is proceeding with utmost diligence in order to launch these in their respective markets as soon as practically possible.
HUMAN HEALTH
Within Human Health, Oasmia has three product candidates in development all of which are novel formulations of current cytostatics for treatment of cancer, with an improved safety and/or effect, which leads to an improved quality of life for the patient.
Paclical®
Paclical® is a novel formulation of the well-known substance paclitaxel which is frequently used within treatment of cancer.
The Phase III study with Paclical® reached an enrolment of 650 patients in September 2011. Based on this has Oasmia since then worked on compiling the documentation for applications of market authorizations to authorities in Russia, EU, Israel and Turkey.
In August 2011, Oasmia announced the results of an interim analysis comprising 400 patients in the Phase III study with Paclical® for treatment of ovarian cancer. The results met the clinical criteria stated by the EMA for submitting an application for market approval for Paclical®.
In August 2011, Oasmia and Orion terminated the collaboration for Paclical® and all rights returned to Oasmia.
In May 2011, a license- and distribution agreement was signed with Medison Pharma for Paclical® in Israel and Turkey.
Paclical® is designated as an orphan drug by the pharmaceutical authorities EMA (EU) and FDA (USA) for the indication ovarian cancer. Orphan drug status is granted for minor indications and entails seven (USA) and ten (EU) years market exclusivity respectively on the indication, when a market approval is granted.
Doxophos®
Doxophos® is a novel patented formulation of doxorubicin, one of the most effective and used substances for treatment of cancer. Currently, doxorubicin is used for treatment of about 20 different types of cancer. Oasmia has performed pre-clinical studies with Doxophos® and preparations are being made to start a clinical Phase I study.
Docecal®
Docecal® is a new patented formulation of docetaxel (Taxotere®). Oasmia intends to focus on the same indications as Taxotere®, i.e. breast cancer, prostate cancer and non-small cell lung cancer. Oasmia has performed preclinical studies with Docecal® and preparations are underway to begin a clinical Phase I study.
ANIMAL HEALTH
Oasmia has two product candidates in development within Animal Health for treatment of the two most common cancers in dogs.
Paccal® Vet
Paccal® Vet is a novel formulation of the well-known substance paclitaxel.
In March 2012, Oasmia reported that the company intends to complement its application of registration with the EMA of Paccal® Vet for treatment of mastocytoma (a type of skin cancer) in dogs. Oasmia will consider the concern EMA had regarding the risk/benefit-ratio. Formal procedure demands that the previous filing is withdrawn, and resubmitted with further complementary data. Oasmia is currently undertaking a smaller study to provide this data, and have also requested scientific counsel from the EMA to support the study design.
Oasmia's application of market approval for Paccal® Vet for treatment of mastocytoma, squamous cell carcinoma (conditional approval) and mammary tumors (conditional approval) in dogs is currently being processed by the FDA and Oasmia is now awaiting information from the authority.
It has been Oasmia's ambition to increase the indications for Paccal® Vet in the USA to more than just mastocytoma and this has been successful:
- In January 2012, Paccal® Vet was granted MUMS-designation (see below) by the FDA for the indication mammary carcinoma.
- In June 2011, Paccal® Vet was granted MUMS-designation by the FDA for the indication squamous cell carcinoma, a type of skin cancer.
- Paccal® Vet has previously been granted MUMS-designation by the FDA for the indication mastocytoma.
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 approval with seven years market exclusivity.
Doxophos® Vet
Doxophos® Vet is intended for treatment of lymphoma, the most common cancer indication in dogs. Oasmia is currently conducting a Phase I study for this product candidate comprising 15 dogs.
THE COMPANY
Chief Executive Officer in Oasmia There is no on-going process to find a replacement for CEO Julian Aleksov.
Change of subsidiary names
In March, the names of two dormant subsidiaries were changed into Oasmia Animal Health AB and Oasmia Global Supplies AB.
Ongoing extension of patent protection
In March 2012, Oasmia reported that the patent protection for the company technology, which comprises all important world markets, has been extended to the end of 2028 by submission and approval of new patent applications made by Oasmia.
New loans
In February 2012, Oasmia raised a MSEK 25 loan from Nexttobe AB, the second largest shareholder in the company. The interest rate is 5 %. At the same time, a reduction of the credit facility from Alceco, the largest shareholder in the company, was made from MSEK 40 to MSEK 25. When used, the interest rate is 5 %.
Private placement
In October 2011, a private placement was made to a limited number of investors. The share issue provided the company with MSEK 48 before issue expenses. The largest block, MSEK 30, was subscribed by the company Nexttobe AB. In connection to the share issue, Nexttobe AB also acquired shares from Oasmia's largest owner Alceco and thereby became the second largest shareholder in Oasmia with about 10 % of the shares and votes. Alceco held about 46 % of the shares and votes after the share issue and sales.
EVENTS AFTER THE CLOSING DAY
Oasmia and Orion jointly end Paccal® Vet agreement. Oasmia is finalizing an agreement with another party Oasmia Pharmaceutical AB and Orion Corporation jointly agreed to end the agreement regarding distribution of Paccal® Vet. The territory included most countries in Europe. In connection to this, Oasmia pays Orion EUR 2 million as a re-purchase of all rights.
Oasmia is finalizing an agreement with a major international pharmaceutical company regarding distribution rights for the territories in the world where Oasmia does not already have a partner, including all countries in Europe. Existing partners, and their respective licensed territories, are Abbott Laboratories in USA/Canada and Nippon Zenyaku in Japan. This agreement has an expanded scope including the product candidates Paccal Vet and Doxophos® Vet.
Nexttobe AB expands its commitment to Oasmia through a MSEK 65 loan.
In May 2012 Nexttobe AB expanded its commitment in Oasmia, this time by an additional loan of MSEK 65. The interest rate is 5 %. Nexttobe is the second largest shareholder and Oasmia had previously raised a MSEK 25 loan from them which makes the total borrowing from Nexttobe to Oasmia MSEK 90.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | 100 | 12 |
| Capitalized development cost | 1,610 | 2,280 | 7,110 | 9,668 |
| Operating income | -2,182 | -2,445 | -7,363 | -7,230 |
| Net income after tax | -2,218 | -2,417 | -7,378 | -7,411 |
| Earnings per share (€), before and after dilution* | -0.04 | -0.05 | -0.13 | -0.17 |
| Comprehensive income for the period | -2,218 | -2,417 | -7,378 | -7,411 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2010/2011.
Net sales
Net sales for the fiscal year amounted to € 100 thousand (12) and consisted of license revenue in connection to closing an agreement with Medison Pharma.
In the fourth quarter, the company had no revenues (-).
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. They amounted to € 7,110 thousand (9,668) for the year and concerned Paclical® only. The reduction compared to the same period previous year is due to that no capitalization is made for Paccal® Vet this year and that the costs for Paclical® was reduced compared to the previous year.
During the fourth quarter, capitalization amounted to € 1,610 thousand (2,280).
Operating expenses
The total operating expenses excluding depreciation and impairment amounted to € 14,016 thousand (16,400). This is a decrease with 15 % and is attributable to expenses for Paccal® Vet in Phase III had all but ended at the start of the year and that expenses for Paclical® in Phase III are no longer increasing.
Of these operating expenses about half, 51 % (59), concerned the company 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.
Operating expenses during the fourth quarter amounted to € 3,654 thousand (4,585).
The number of employees was 77 (68) at the end of the year. During the fourth quarter, the number of employees decreased from 80 to 77.
Income for the year
Net income for the year was € -7,378 thousand (-7,411). In the fourth quarter, the corresponding income amounted to € -2,218 thousand (-2,417).
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 year amounted to € 228 thousand (5,831). Equity at the same time amounted to € 30,726 thousand (33,051). At the end of the year, the equity/assets ratio was 78 % (92) and the debt/equity ratio 11 % (0).
On April 30, the company had available credits amounting to TSEK 30 000, where TSEK 7 797 had been utilized. In addition, the company had raised a TSEK 25 000 loan from Nexttobe and has an unutilized SEDA-agreement (standby equity distribution agreement) amounting to TSEK 75 000.
Cash flow and Capital expenditures
Cash flow from operating activities in the year amounted to € -5,892 thousand (-6,471).
Capital expenditures for the year amounted to € 8,549 thousand (11,085).
Investments in intangible assets amounted to € 8,222 thousand (9,926), consisting of capitalized development costs € 7,110 thousand and patents and other intangible assets € 1,112 thousand.
Investments in property, plant and equipment amounted to € 327 thousand (1,160) and concerned production equipment. The reason that investments were considerably higher previous year was that the production facility in Uppsala was then subject to a large upgrade.
Financing
Financing in the period was performed by use of liquid assets at the beginning of the year. In October, a private placement provided the company with € 5,053 thousand after issue expenses and in the final quarter the business activities were financed by loans and utilization of credits.
The parent company
The parent company net sales in the year amounted to € 100 thousand (12) and net income before tax amounted to € -7,396 thousand (-7,415). The parent company liquid assets at the end of the year amounted to € 227 thousand (5,829).
Key ratios and other information
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| Feb-April | Feb-April | May-April | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* | 57,241 | 52,079 | 57,241 | 52,079 |
| Weighted average number of shares (in thousands) before and after dilution* | 57,241 | 52,079 | 54,660 | 44,061 |
| Earnings per share in €, before and after dilution* | -0.04 | -0.05 | -0.13 | -0.17 |
| Equity per share, €* | 0.54 | 0.63 | 0.54 | 0.63 |
| Equity/Assets ratio, % | 78 | 92 | 78 | 92 |
| Net liability, € thousand | 3,457 | -5,831 | 3,457 | -5,831 |
| Debt/Equity ratio, % | 11 | 0 | 11 | 0 |
| Return on total assets, % | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg |
| Number of employees at the end of the period | 77 | 68 | 77 | 68 |
*Recalculation of historical values has been made with respect to capitalization issue elements in the preferential rights share issue carried out in the third quarter 2010/11.
Definitions
Earnings per share: 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 assets: 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
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | 100 | 12 |
| Capitalized development cost | 1,610 | 2,280 | 7,110 | 9,668 |
| Other operating income | 5 | 16 | 12 | 30 |
| Raw materials, consumables and goods for resale | -256 | -747 | -1,138 | -1,811 |
| Other external expenses | -2,122 | -2,711 | -8,256 | -10,390 |
| Employee benefit expenses | -1,276 | -1,127 | -4,623 | -4,199 |
| Depreciation/amortization and impairment | -143 | -141 | -569 | -525 |
| Other operating expenses | - | -15 | - | -15 |
| Operating income | -2,182 | -2,445 | -7,363 | -7,230 |
| Financial income | 3 | 28 | 41 | 54 |
| Financial expenses | -38 | -1 | -56 | -236 |
| Financial items, net | -36 | 27 | -15 | -181 |
| Income before taxes | -2,218 | -2,418 | -7,378 | -7,412 |
| Taxes | - | 1 | - | 1 |
| Income for the period | -2,218 | -2,417 | -7,378 | -7,411 |
| Income for the period attributable to: | ||||
| Equity holders of the Parent company | -2,218 | -2,417 | -7,378 | -7,411 |
| Non-controlling interest | - | - | - | - |
| Earnings per share | ||||
| Before dilution, € | -0.04 | -0.05 | -0.13 | -0.17 |
| After dilution, € | -0.04 | -0.05 | -0.13 | -0.17 |
Consolidated Statement of Comprehensive income
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Income for the period | -2,218 | -2,417 | -7,378 | -7,411 |
| Comprehensive income for the period | -2,218 | -2,417 | -7,378 | -7,411 |
| Comprehensive income for the period attributable to: | ||||
| Equity holders of the Parent company | -2,218 | -2,417 | -7,378 | -7,411 |
| Non-controlling interest | - | - | - | - |
| Comprehensive Earnings per share | ||||
| Before dilution, € | -0.04 | -0.05 | -0.13 | -0.17 |
| After dilution, € | -0.04 | -0.05 | -0.13 | -0.17 |
Consolidated statement of financial position
| € thousands | 2012-04-30 | 2011-04-30 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Property, plant and equipment | 2,920 | 3,061 |
| Capitalized development cost | 32,604 | 25,494 |
| Other intangible assets | 3,079 | 1,042 |
| Financial assets | 0 | 0 |
| Total Non-current assets | 38,603 | 29,597 |
| Current assets | ||
| Inventories | 33 | - |
| Other current receivables | 196 | 241 |
| Prepaid expenses and accrued income | 243 | 321 |
| Liquid assets | 228 | 5,831 |
| Total Current assets | 700 | 6,392 |
| TOTAL ASSETS | 39,302 | 35,989 |
| EQUITY | ||
| Equity attributed to equity holders in the Parent Company | ||
| Share capital | 643 | 585 |
| Other capital provided | 51,439 | 46,444 |
| Retained earnings | -21,357 | -13,978 |
| Total | 30,726 | 33,051 |
| Non-controlling interest | - | - |
| Total equity | 30,726 | 33,051 |
| LIABILITIES | ||
| Non-current liabilities | ||
| Other non-current liabilities | 1,827 | 1,727 |
| Total Non-current liabilities | 1,827 | 1,727 |
| Current liabilities | ||
| Liabilities to credit institutions | 359 | - |
| Short-term borrowings | 3,326 | - |
| Trade payables | 1,155 | 430 |
| Other current liabilities | 1,215 | 157 |
| Accrued expenses and prepaid income | 694 | 623 |
| Total Current liabilities | 6,749 | 1,211 |
| Total Liabilities | 8,576 | 2,938 |
| TOTAL EQUITY AND LIABILITIES | 39,302 | 35,989 |
Consolidated statement of changes in equity
| Attributable to equity holders in Parent company | ||||||
|---|---|---|---|---|---|---|
| Other | Non | |||||
| capital | controlling | |||||
| € thousands | Share capital | provided | Retained earnings | interest | Total equity | |
| Opening balance as of May 1, 2010 | 423 | 22,077 | -6,574 | 6 | 15,932 | |
| Comprehensive income for the period | - | - | -7,411 | - | -7,411 | |
| Acquired non-controlling interest | - | - | 6 | -6 | 0 | |
| New share issue | 163 | 26,656 | - | - | 26,819 | |
| Issue expenses | - | -2,289 | - | - | -2,289 | |
| Closing balance as of April 30, 2011 | 585 | 46,444 | -13,978 | 0 | 33,051 | |
| Opening balance as of May 1, 2011 | 585 | 46,444 | -13,978 | 0 | 33,051 | |
| Comprehensive income for the period | - | - | -7,378 | - | -7,378 | |
| New share issue | 58 | 5,335 | - | - | 5,393 | |
| Issue expenses | - | -340 | - | - | -340 | |
| Closing balance as of April 30, 2012 | 643 | 51,439 | -21,357 | 0 | 30,726 |
Consolidated Cash flow statement
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Operating activities | ||||
| Operating income before financial items | -2,182 | -2,445 | -7,363 | -7,230 |
| Depreciation/amortization | 143 | 139 | 569 | 522 |
| Impairment of inventory | - | 11 | - | 11 |
| Disposals of intangible assets | - | 15 | - | 15 |
| Interest received | 3 | 28 | 41 | 54 |
| Interest paid | -38 | -1 | -56 | -156 |
| Cash flow from operating activities before | ||||
| working capital changes | -2,075 | -2,254 | -6,810 | -6,784 |
| Change in working capital | ||||
| Change in inventories | - | - | -33 | - |
| Change in trade receivables | - | - | - | 7 |
| Change in other current receivables | -22 | 239 | 122 | -50 |
| Change in trade payables | 533 | -7 | 725 | 197 |
| Change in other current liabilities | 127 | 104 | 104 | 159 |
| Cash flow from operating activities | -1,436 | -1,918 | -5,892 | -6,471 |
| Investing activities | ||||
| Investments in intangible fixed assets | -2,461 | -2,335 | -8,222 | -9,926 |
| Investments in property, plant and equipment | -114 | -145 | -327 | -1,160 |
| Cash flow from investing activities | -2,575 | -2,480 | -8,549 | -11,085 |
| Financing activities | ||||
| Increase in liabilities to credit institutions | 359 | - | 359 | - |
| Decrease in liabilities to credit institutions | - | - | - | -482 |
| Increase in long-term liabilities | - | - | 100 | - |
| New share issue | - | - | 5,393 | 18,954 |
| Issue expenses | - | - | -340 | -2,289 |
| New loans | 3,326 | - | 3,326 | 6,600 |
| Cash flow from financing activities | 3,685 | 0 | 8,838 | 22,784 |
| Cash flow for the period Cash and cash equivalents at the beginning of the period |
-326 554 |
-4,398 10,229 |
-5,603 5,831 |
5,227 604 |
| Cash and cash equivalents at the end of the period | 228 | 5,831 | 228 | 5,831 |
Oasmia Pharmaceutical AB (publ)
Year-end report
for the fiscal year May 2011- April 2012
THE FISCAL YEAR May 1, 2011 – April 30, 2012
- Consolidated Net sales amounted to TSEK 891 (106) 2
- Operating income amounted to TSEK 65 536 (-64 353)
- Net income after tax amounted to TSEK 65 670 (-65 960)
- Earnings per share amounted to SEK -1,20 (-1,50)
- Comprehensive income amounted to TSEK -65 670 (-65 960)
THE FOURTH QUARTER February 1 – April 30, 2012
- Consolidated Net sales amounted to TSEK 0 (0)
- Operating income amounted to TSEK 19 419 (-21 764)
- Net income after tax amounted to TSEK 19 737 (-21 513)
- Earnings per share amounted to SEK -0,34 (-0,41)
- Comprehensive income amounted to TSEK 19 737 (-21 513)
- Oasmia intends to complement the application for market approval with the EMA by performing a new smaller study.
EVENTS AFTER CLOSING DAY
- Oasmia and Orion jointly end Paccal® Vet agreement. Oasmia is finalizing an agreement with another party.
- Nexttobe AB expands commitment to Oasmia through a MSEK 65 loan.
BUSINESS ACTIVITIES IN THE YEAR
2 The numbers in parentheses concerns results for the corresponding period previous year
PRODUCT DEVELOPMENT
Oasmia's product candidates are in varying stages of pre-clinical and clinical development. Two of them are in late final clinical phase and Oasmia is proceeding with utmost diligence in order to launch these in their respective markets as soon as practically possible.
HUMAN HEALTH
Within Human Health, Oasmia has three product candidates in development all of which are novel formulations of current cytostatics for treatment of cancer, with an improved safety and/or effect, which leads to an improved quality of life for the patient.
Paclical®
Paclical® is a novel formulation of the well-known substance paclitaxel which is frequently used within treatment of cancer.
The Phase III study with Paclical® reached an enrolment of 650 patients in September 2011. Based on this has Oasmia since then worked on compiling the documentation for applications of market authorizations to authorities in Russia, EU, Israel and Turkey.
In August 2011, Oasmia announced the results of an interim analysis comprising 400 patients in the Phase III study with Paclical® for treatment of ovarian cancer. The results met the clinical criteria stated by the EMA for submitting an application for market approval for Paclical®.
In August 2011, Oasmia and Orion terminated the collaboration for Paclical® and all rights returned to Oasmia.
In May 2011, a license- and distribution agreement was signed with Medison Pharma for Paclical® in Israel and Turkey.
Paclical® is designated as an orphan drug by the pharmaceutical authorities EMA (EU) and FDA (USA) for the indication ovarian cancer. Orphan drug status is granted for minor indications and entails seven (USA) and ten (EU) years market exclusivity respectively on the indication, when a market approval is granted.
Doxophos®
Doxophos® is a novel patented formulation of doxorubicin, one of the most effective and used substances for treatment of cancer. Currently, doxorubicin is used for treatment of about 20 different types of cancer. Oasmia has performed pre-clinical studies with Doxophos® and preparations are being made to start a clinical Phase I study.
Docecal®
Docecal® is a new patented formulation of docetaxel (Taxotere®). Oasmia intends to focus on the same indications as Taxotere®, i.e. breast cancer, prostate cancer and non-small cell lung cancer. Oasmia has performed preclinical studies with Docecal® and preparations are underway to begin a clinical Phase I study.
ANIMAL HEALTH
Oasmia has two product candidates in development within Animal Health for treatment of the two most common cancers in dogs.
Paccal® Vet
Paccal® Vet is a novel formulation of the well-known substance paclitaxel.
In March 2012, Oasmia reported that the company intends to complement its application of registration with the EMA of Paccal® Vet for treatment of mastocytoma (a type of skin cancer) in dogs. Oasmia will consider the concern EMA had regarding the risk/benefit-ratio. Formal procedure demands that the previous filing is withdrawn, and resubmitted with further complementary data. Oasmia is currently undertaking a smaller study to provide this data, and have also requested scientific counsel from the EMA to support the study design.
Oasmia's application of market approval for Paccal® Vet for treatment of mastocytoma, squamous cell carcinoma (conditional approval) and mammary tumors (conditional approval) in dogs is currently being processed by the FDA and Oasmia is now awaiting information from the authority.
It has been Oasmia's ambition to increase the indications for Paccal® Vet in the USA to more than just mastocytoma and this has been successful:
- In January 2012, Paccal® Vet was granted MUMS-designation (see below) by the FDA for the indication mammary carcinoma.
- In June 2011, Paccal® Vet was granted MUMS-designation by the FDA for the indication squamous cell carcinoma, a type of skin cancer.
- Paccal® Vet has previously been granted MUMS-designation by the FDA for the indication mastocytoma.
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 approval with seven years market exclusivity.
Doxophos® Vet
Doxophos® Vet is intended for treatment of lymphoma, the most common cancer indication in dogs. Oasmia is currently conducting a Phase I study for this product candidate comprising 15 dogs.
THE COMPANY
Chief Executive Officer in Oasmia There is no on-going process to find a replacement for CEO Julian Aleksov.
Change of subsidiary names
In March, the names of two dormant subsidiaries were changed into Oasmia Animal Health AB and Oasmia Global Supplies AB.
Ongoing extension of patent protection
In March 2012, Oasmia reported that the patent protection for the company technology, which comprises all important world markets, has been extended to the end of 2028 by submission and approval of new patent applications made by Oasmia.
New loans
In February 2012, Oasmia raised a MSEK 25 loan from Nexttobe AB, the second largest shareholder in the company. The interest rate is 5 %. At the same time, a reduction of the credit facility from Alceco, the largest shareholder in the company, was made from MSEK 40 to MSEK 25. When used, the interest rate is 5 %.
Private placement
In October 2011, a private placement was made to a limited number of investors. The share issue provided the company with MSEK 48 before issue expenses. The largest block, MSEK 30, was subscribed by the company Nexttobe AB. In connection to the share issue, Nexttobe AB also acquired shares from Oasmia's largest owner Alceco and thereby became the second largest shareholder in Oasmia with about 10 % of the shares and votes. Alceco held about 46 % of the shares and votes after the share issue and sales.
EVENTS AFTER THE CLOSING DAY
Oasmia and Orion jointly end Paccal® Vet agreement. Oasmia is finalizing an agreement with another party Oasmia Pharmaceutical AB and Orion Corporation jointly agreed to end the agreement regarding distribution of Paccal® Vet. The territory included most countries in Europe. In connection to this, Oasmia pays Orion EUR 2 million as a re-purchase of all rights.
Oasmia is finalizing an agreement with a major international pharmaceutical company regarding distribution rights for the territories in the world where Oasmia does not already have a partner, including all countries in Europe. Existing partners, and their respective licensed territories, are Abbott Laboratories in USA/Canada and Nippon Zenyaku in Japan. This agreement has an expanded scope including the product candidates Paccal Vet and Doxophos® Vet.
Nexttobe AB expands its commitment to Oasmia through a MSEK 65 loan.
In May 2012 Nexttobe AB expanded its commitment in Oasmia, this time by an additional loan of MSEK 65. The interest rate is 5 %. Nexttobe is the second largest shareholder and Oasmia had previously raised a MSEK 25 loan from them which makes the total borrowing from Nexttobe to Oasmia MSEK 90.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| TSEK | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | 891 | 106 |
| Capitalized development cost | 14 332 | 20 291 | 63 282 | 86 049 |
| Operating income | -19 419 | -21 764 | -65 536 | -64 353 |
| Net income after tax | -19 737 | -21 513 | -65 670 | -65 960 |
| Earnings per share (SEK), before and after dilution* | -0,34 | -0,41 | -1,20 | -1,50 |
| Comprehensive income for the period | -19 737 | -21 513 | -65 670 | -65 960 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2010/2011.
Net sales
Net sales for the fiscal year amounted to TSEK 891 (106) and consisted of license revenue in connection to closing an agreement with Medison Pharma.
In the fourth quarter, the company had no revenues (-).
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. They amounted to TSEK 63 282 (86 049) for the year and concerned Paclical® only. The reduction compared to the same period previous year is due to that no capitalization is made for Paccal® Vet this year and that the costs for Paclical® was reduced compared to the previous year.
During the fourth quarter, capitalization amounted to TSEK 14 332 (20 291).
Operating expenses
The total operating expenses excluding depreciation and impairment amounted to TSEK 124 751 (145 970). This is a decrease with 15 % and is attributable to expenses for Paccal® Vet in Phase III had all but ended at the start of the year and that expenses for Paclical® in Phase III are no longer increasing.
Of these operating expenses about half, 51 % (59), concerned the product candidates in Phase III and were capitalized as Capitalized development cost. The share of capitalized operating expenses is decreasing successively, which has a negative effect on the company income.
Operating expenses during the fourth quarter amounted to TSEK 32 525 (40 810).
The number of employees was 77 (68) at the end of the year. During the fourth quarter, the number of employees decreased from 80 to 77.
Income for the year Net income for the year was TSEK -65 670 (-65 960). In the fourth quarter, the corresponding income amounted to TSEK -19 737 (-21 513).
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 year amounted to TSEK 2 028 (51 895). Equity at the same time amounted to TSEK 273 474 (294 171). At the end of the year, the equity/assets ratio was 78 % (92) and the debt/equity ratio 11 % (0).
On April 30, the company had available credits amounting to TSEK 30 000, where TSEK 7 797 had been utilized. In addition, the company had raised a TSEK 25 000 loan from Nexttobe and has an unutilized SEDA-agreement (standby equity distribution agreement) amounting to TSEK 75 000.
Cash flow and Capital expenditures
Cash flow from operating activities in the year amounted to TSEK -52 439 (-57 598).
Capital expenditures for the year amounted to TSEK 76 090 (98 663).
Investments in intangible assets amounted to TSEK 73 176 (88 342), consisting of capitalized development costs TSEK 63 282 and patents and other intangible assets TSEK 9 894.
Investments in property, plant and equipment amounted to TSEK 2 914 (10 321) and concerned production equipment. The reason that investments were considerably higher previous year was that the production facility in Uppsala was then subject to a large upgrade.
Financing
Financing in the period was performed by use of liquid assets at the beginning of the year. In October, a private placement provided the company with TSEK 44 973 after issue expenses and in the final quarter the business activities were financed by loans and utilization of credits.
The parent company
The parent company net sales in the year amounted to TSEK 891 (106) and net income before tax amounted to TSEK -65 823 (-65 998). The parent company liquid assets at the end of the year amounted to TSEK 2 020 (51 884).
Key ratios and other information
| 2012 | 2011 | 2011/12 | 2010/11 | |
|---|---|---|---|---|
| Feb-April | Feb-April | May-April | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* Weighted average number of shares (in thousands) before and after dilu |
57 241 | 52 079 | 57 241 | 52 079 |
| tion* | 57 241 | 52 079 | 54 660 | 44 061 |
| Earnings per share in SEK, before and after dilution* | -0,34 | -0,41 | -1,20 | -1,50 |
| Equity per share, SEK* | 4,78 | 5,65 | 4,78 | 5,65 |
| Equity/Assets ratio, % | 78 | 92 | 78 | 92 |
| Net liability, TSEK | 30 769 | -51 895 | 30 769 | -51 895 |
| Debt/Equity ratio, % | 11 | 0 | 11 | 0 |
| Return on total assets, % | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg |
| Number of employees at the end of the period | 77 | 68 | 77 | 68 |
*Recalculation of historical values has been made with respect to capitalization issue elements in the preferential rights share issue carried out in the third quarter 2010/11.
Definitions
Earnings per share: 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 assets: 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
| 2012 | 2011 | 2011/12 | 2010/11 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | 891 | 106 | |
| Capitalized development cost | 14 332 | 20 291 | 63 282 | 86 049 | |
| Other operating income | 46 | 145 | 104 | 269 | |
| Raw materials, consumables and goods for resale | -2 281 | -6 646 | -10 127 | -16 120 | |
| Other external expenses | -18 887 | -24 131 | -73 481 | -92 479 | |
| Employee benefit expenses | -11 357 | -10 033 | -41 144 | -37 370 | |
| Depreciation/amortization and impairment | -1 273 | -1 257 | -5 062 | -4 674 | |
| Other operating expenses | - | -133 | - | -133 | |
| Operating income | -19 419 | -21 764 | -65 536 | -64 353 | |
| Financial income | 23 | 253 | 363 | 484 | |
| Financial expenses | -341 | -8 | -497 | -2 097 | |
| Financial items, net | -318 | 245 | -135 | -1 613 | |
| Income before taxes | -19 737 | -21 520 | -65 670 | -65 967 | |
| Taxes | 2 | - | 7 | - | 7 |
| Income for the period | -19 737 | -21 513 | -65 670 | -65 960 | |
| Income for the period attributable to: | |||||
| Equity holders of the Parent company | -19 737 | -21 513 | -65 670 | -65 960 | |
| Non-controlling interest | - | - | - | - | |
| Earnings per share | |||||
| Before dilution, SEK | -0,34 | -0,41 | -1,20 | -1,50 | |
| After dilution, SEK | -0,34 | -0,41 | -1,20 | -1,50 | |
Consolidated Statement of Comprehensive income
| 2012 | 2011 | 2011/12 | 2010/11 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Income for the period | -19 737 | -21 513 | -65 670 | -65 960 | |
| Comprehensive income for the period | -19 737 | -21 513 | -65 670 | -65 960 | |
| Comprehensive income for the period attributable to: |
|||||
| Equity holders of the Parent company | -19 737 | -21 513 | -65 670 | -65 960 | |
| Non-controlling interest | - | - | - | - | |
| Comprehensive Earnings per share | |||||
| Before dilution, SEK | -0,34 | -0,41 | -1,20 | -1,50 | |
| After dilution, SEK | -0,34 | -0,41 | -1,20 | -1,50 |
Consolidated statement of financial position
| TSEK | Note | 2012-04-30 | 2011-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 25 988 | 27 243 | |
| Capitalized development cost | 3 | 290 191 | 226 909 |
| Other intangible assets | 27 400 | 9 276 | |
| Financial assets | 2 | 2 | |
| Total Non-current assets | 343 581 | 263 430 | |
| Current assets | |||
| Inventories | 290 | - | |
| Other current receivables | 1 747 | 2 141 | |
| Prepaid expenses and accrued income | 2 161 | 2 853 | |
| Liquid assets | 2 028 | 51 895 | |
| Total Current assets | 6 227 | 56 889 | |
| TOTAL ASSETS | 349 807 | 320 319 | |
| EQUITY | |||
| Equity attributed to equity holders in the Parent Company | |||
| Share capital | 5 724 | 5 208 | |
| Other capital provided | 457 832 | 413 375 | |
| Retained earnings | -190 082 | -124 411 | |
| Total | 273 474 | 294 171 | |
| Non-controlling interest | - | - | |
| Total equity | 273 474 | 294 171 | |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 16 264 | 15 373 | |
| Total Non-current liabilities | 16 264 | 15 373 | |
| Current liabilities | |||
| Liabilities to credit institutions | 3 197 | - | |
| Short-term borrowings | 4 | 29 600 | - |
| Trade payables | 10 281 | 3 831 | |
| Other current liabilities | 10 811 | 1 399 | |
| Accrued expenses and prepaid income | 6 180 | 5 545 | |
| Total Current liabilities | 60 069 | 10 775 | |
| Total Liabilities | 76 334 | 26 148 | |
| TOTAL EQUITY AND LIABILITIES | 349 807 | 320 319 | |
| Contingent liabilities | 5 | ||
| Pledged assets | 5 |
Consolidated statement of changes in equity
| Attributable to equity holders in Parent company | |||||
|---|---|---|---|---|---|
| Other | Non | ||||
| capital | controlling | ||||
| TSEK | Share capital | provided | Retained earnings | interest | Total equity |
| Opening balance as of May 1, 2010 | 3 761 | 196 493 | -58 509 | 57 | 141 803 |
| Comprehensive income for the period | - | - | -65 960 | - | -65 960 |
| Acquired non-controlling interest | - | - | 57 | -57 | 0 |
| New share issue | 1 447 | 237 250 | - | - | 238 697 |
| Issue expenses | - | -20 369 | - | - | -20 369 |
| Closing balance as of April 30, 2011 | 5 208 | 413 375 | -124 411 | 0 | 294 171 |
| Opening balance as of May 1, 2011 | 5 208 | 413 375 | -124 411 | 0 | 294 171 |
| Comprehensive income for the period | - | - | -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 | 0 | 273 474 |
Consolidated Cash flow statement
| 2012 | 2011 | 2011/12 | 2010/11 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Operating activities | |||||
| Operating income before financial items | -19 419 | -21 764 | -65 536 | -64 353 | |
| Depreciation/amortization | 1 273 | 1 233 | 5 062 | 4 650 | |
| Impairment of inventory | - | 94 | - | 94 | |
| Disposals of intangible assets | - | 133 | - | 133 | |
| Interest received | 23 | 253 | 363 | 484 | |
| Interest paid | -341 | -8 | -497 | -1 392 | |
| Cash flow from operating activities before | |||||
| working capital changes | -18 464 | -20 060 | -60 609 | -60 385 | |
| Change in working capital | |||||
| Change in inventories | - | - | -290 | - | |
| Change in trade receivables | - | - | - | 60 | |
| Change in other current receivables | -195 | 2 128 | 1 085 | -445 | |
| Change in trade payables | 4 748 | -65 | 6 450 | 1 756 | |
| Change in other current liabilities | 1 129 | 925 | 924 | 1 415 | |
| Cash flow from operating activities | -12 782 | -17 072 | -52 439 | -57 598 | |
| Investing activities | |||||
| Investments in intangible fixed assets | -21 906 | -20 783 | -73 176 | -88 342 | |
| Investments in property, plant and equipment | -1 011 | -1 291 | -2 914 | -10 321 | |
| Cash flow from investing activities | -22 917 | -22 074 | -76 090 | -98 663 | |
| Financing activities | |||||
| Increase in liabilities to credit institutions | 3 197 | - | 3 197 | - | |
| Decrease in liabilities to credit institutions | - | - | - | -4 289 | |
| Increase in long-term liabilities | - | - | 891 | - | |
| New share issue | - | - | 48 000 | 168 697 | |
| Issue expenses | - | - | -3 027 | -20 369 | |
| New loans | 4 | 29 600 | - | 29 600 | 58 745 |
| Cash flow from financing activities | 32 797 | 0 | 78 662 | 202 784 | |
| Cash flow for the period | -2 902 | -39 146 | -49 867 | 46 523 | |
| Cash and cash equivalents at the beginning of the period | 4 930 | 91 041 | 51 895 | 5 372 | |
| Cash and cash equivalents at the end of the period | 2 028 | 51 895 | 2 028 | 51 895 |
Parent Company Income statement
| 2012 | 2011 | 2011/12 | 2010/11 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | - | - | 891 | 106 | |
| Capitalized development cost | 14 332 | 20 291 | 63 282 | 86 049 | |
| Other operating income | 46 | 121 | 104 | 245 | |
| Raw materials, consumables and goods for resale | -2 281 | -6 646 | -10 124 | -16 080 | |
| Other external expenses | -18 845 | -24 072 | -73 323 | -92 271 | |
| Employee benefit expenses | -11 357 | -10 033 | -41 144 | -37 370 | |
| Depreciation/amortization and impairment of | |||||
| property, plant, equipment and intangible assets | -1 265 | -1 199 | -4 987 | -4 486 | |
| Operating income | -19 370 | -21 538 | -65 300 | -63 806 | |
| Result from participations in Group companies | 4 | -105 | -288 | -390 | -578 |
| Other interest revenues and similar revenues | 23 | 253 | 362 | 483 | |
| Interest cost and similar costs | -340 | -8 | -495 | -2 097 | |
| Financial items, net | -422 | -43 | -523 | -2 192 | |
| Income after financial items | -19 791 | -21 582 | -65 823 | -65 998 | |
| Taxes | 2 | - | - | - | - |
| Income for the period | -19 791 | -21 582 | -65 823 | -65 998 |
Parent Company Balance Sheet
| TSEK | Note | 2012-04-30 | 2011-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible fixed assets | |||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 290 191 | 226 909 |
| similar rights | 27 378 | 9 180 | |
| Property, plant and equipment | |||
| Equipment, tools, fixtures and fittings | 24 149 | 27 243 | |
| Advance payments for property, plant and equipment | 1 839 | - | |
| Financial assets | |||
| Participations in group companies | 110 | 110 | |
| Receivables from group companies | - | 5 | |
| Other securities held as non-current assets | 1 | 1 | |
| Total Non-current assets | 343 668 | 263 448 | |
| Current assets | |||
| Inventories | |||
| Raw materials and consumables | 290 | - | |
| 290 | 0 | ||
| Current receivables | |||
| Receivables from group companies | 4 | 55 | 89 |
| Other current receivables | 1 746 | 2 140 | |
| Prepaid expenses and accrued income | 2 084 | 2 748 | |
| 3 885 | 4 977 | ||
| Cash and bank balances | 2 020 | 51 884 | |
| Total current assets | 6 195 | 56 861 | |
| TOTAL ASSETS | 349 863 | 320 309 | |
| EQUITY AND LIABILITIES | |||
| Equity Restricted equity |
|||
| Share capital | 5 724 | 5 208 | |
| Statutory reserve | 4 620 | 4 620 | |
| 10 344 | 9 828 | ||
| Non-restricted equity | |||
| Share premium reserve | 457 832 | 413 375 | |
| Retained earnings | -129 028 | -63 030 | |
| Income for the period | -65 823 | -65 998 | |
| 262 981 | 284 347 | ||
| Total equity | 273 325 | 294 175 | |
| Non-current liabilities | |||
| Other non-current liabilities | 16 264 | 15 373 | |
| Total non-current liabilities | 16 264 | 15 373 | |
| Current liabilities | |||
| Short term borrowings | 4 | 29 600 | - |
| Trade payables | 10 281 | 3 818 | |
| Liabilities to Credit institutions | 3 197 | - | |
| Liabilities to group companies | 205 | - | |
| Other current liabilities | 10 811 | 1 399 | |
| Accrued expenses and prepaid income | 6 180 | 5 545 | |
| Total Current liabilities | 60 274 | 10 761 | |
| TOTAL EQUITY AND LIABILITIES | 349 863 | 320 309 | |
| Contingent liabilities and pledged assets | |||
| Contingent liabilities | 5 | - | - |
| Pledged assets | 5 | 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, 2010 | 3 761 | 4 620 | 133 464 | 141 845 |
| New share issue | 1 447 | - | 237 250 | 238 697 |
| Issue expenses | - | - | -20 369 | -20 369 |
| Income for the period | - | - | -65 998 | -65 998 |
| Closing balance as of April 30, 2011 | 5 208 | 4 620 | 284 347 | 294 175 |
| Opening balance as of May 1, 2011 | 5 208 | 4 620 | 284 347 | 294 175 |
| 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 |
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 2010 – April 30 2011. The new and revised accounting policies applied by Oasmia since May 1, 2011, 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 228 336 (162 806) and the Parent Company has similar amounting to TSEK 218 900 (153 607). 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 | 2012-04-30 | 2011-04-30 |
|---|---|---|
| Paclical® | 209 140 | 145 858 |
| Paccal® Vet | 81 051 | 81 051 |
| Total | 290 191 | 226 909 |
Note 4 Transactions with related parties
On April 30, 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 April 30, 2012, the company had utilized TSEK 4 600 (-) of this credit facility.
Oasmia has made a TSEK 175 (390) group contribution to Oasmia Global Supplies AB (previously Qdoxx Pharma AB) in the year, of which TSEK 0 (100) in the fourth quarter. In the year, Oasmia has made a TSEK 215 (-) group contribution to Oasmia Animal Health AB (previously Gluco-Gene Pharma AB), of which TSEK 105 (-) in the fourth quarter. Impairments of shares in the subsidiaries amounting to TSEK 390 (578) have been made in the year corresponding to the group contributions, as the purpose of the group contributions was to cover losses in the subsidiaries. The impairments are 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 2010 – April 30 2011. No additional risks beyond those described therein have been judged significant.
The Board of Directors and CEOof 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.
UppsalaJune14,2012
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 June 14, 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.
Dividends
The Board of Directors does not intend to pro pose any dividends for the fiscal year May 1, 2011 €April 30, 2012.
Annual Report
The Annual Report will be published on August 23, 2012 and will be available on the company website www.oasmia.com. The Annual Report may also be requested from Oasmia Phar maceutical AB by phone +46 18 50 54 40 or by e-mail [email protected]m
Annual General Meeting
The Annual General Meeting will be held on September 24, 2012 in the company offices in Uppsala. A notice for the Meeting is distributed four weeks before the Meeti ng at the latest. For more information, see the company website www.oasmia.com
COMPANY INFORMATION
Oasmia Pharmaceutical AB (publ) VAT number: SE556332-667601 Domicile: Stockholm
Address and telephone number to the Main Office Vallongatan 1 752 28UPPSALA, SWEDEN +46 18 50 54 40 www.oasmia.com [email protected]
Questions concerning the report are answered by: Weine Nejdemo, CFO +46 18 50 54 40
UPCOMING REPORT DATES
| Annual report May 2011 – April 2012 | 2012-08-23 |
|---|---|
| Interim report May – July 2012 | 2012-09-06 |
| 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 |
About Oasmia Pharmaceutical AB
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.