AI assistant
Vivesto — Interim / Quarterly Report 2011
Aug 27, 2012
3124_ir_2012-08-27_8bbf4f19-3a0a-44c8-a179-03909c6f7c2f.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - October 2011 €
Pages 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 10-22. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per October 31, 2011 which was 9.0241 SEK per one EUR. Some figures are in SEK because these are very firmly denominated in SEK.
THE PERIOD May 1– October 31, 2011
- Consolidated net sales amounted to € 99 thousand (5) 1
- Operating income amounted to € -3,186 thousand (-2,997)
- Net income after tax amounted to € -3,180 thousand (-3,194)
- Earnings per share was € -0.06 (-0.08)
- Comprehensive income amounted to € -3,180 thousand (-3,194)
SECOND QUARTER August 1– October 31, 2011
- Consolidated net sales amounted to € 0 thousand (0)
- Operating income amounted to € -1,483 thousand (-1,754)
- Net income after tax amounted to € -1,489 thousand (-1,854)
- Earnings per share was € -0.03 (-0.05)
- Comprehensive income amounted to € -1,489 thousand (-1,854)
- Oasmia carries out a SEK 48 million private placement with a new strategic owner
- Enrolment of 650 patients complete in Phase III study with Paclical®
- The Annual General Meeting elected Joel Citron, Martin Nicklasson, Jan Lundberg and Prof. Dr Horst Domdey as Members of the Board
- The Annual General Meeting made a resolution of authorization corresponding to 15 million shares
- Oasmia and Orion concluded Paclical® collaboration in the Nordic countries
1 The numbers in parentheses concerns results for the corresponding period previous year
BUSINESS ACTIVTIES IN THE PERIOD
HUMAN HEALTH
Paclical®
The enrolment of 650 patients in the Phase III study with Paclical® on ovarian cancer was completed in September 2011.
In August 2011, the result was reported from an interim analysis which comprised of about 400 of the 650 patients. The result fulfilled the placed clinical requirement, that Paclical® should be at least as effective as Taxol®.
Important differences between treatments with these two drugs are as follows:
- Extensive premedication is necessary for Taxol® in order to avoid hypersensitivity reactions due to the solvent Cremophor® EL. This is not necessary for Paclical®.
- The infusion time for Paclical® is one hour and three hours for Taxol®.
- Paclical® can be administered in a higher dose (250 mg/m2 ) compared to Taxol® (175 mg/m2 )
The work with the interim analysis has continued in the period concerning other variables which will be included in the application for market authorization.
Oasmia plans to submit applications for market approval for Paclical® in EU, Russia, Israel, Turkey and a few countries in Asia in the beginning of 2012.
The next step for the company after enrolment and treatment of the 650 patients which comprise the study is to evaluate when survival data, an important factor in oncology studies, can be analyzed. The process to determine the number of patients required to obtain such data in a reasonable time is ongoing.
In August 2011, Oasmia and Orion concluded the collaboration for Paclical® and all rights were returned to Oasmia.
In May 2011, a license agreement was closed with Medison Pharma for Paclical® in Israel and Turkey.
Paclical® is previously designated as an orphan drug by the EMA (EU) and the FDA (USA) on the indication ovarian cancer. Orphan Drug designation is granted for minor indications and entails market exclusivity for seven years in the USA and for ten years in the EU on the indication when a market approval has been obtained.
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 20 different types of cancer. Pre-clinical studies have been completed with Doxophos®, and based on this, Oasmia previously planned to start a clinical Phase I study in 2011. The start of the study has been postponed to the first quarter 2012 in order to focus on Paclical® concerning interim analysis and application for market approval.
Docecal®
Docecal® is a new patented formulation of docetaxel (Taxotere®) with improved chemical properties compared to Taxotere®. Oasmia intends to focus on the same indications as Taxotere®, i.e. breast cancer, prostate cancer and non-small cell lung cancer. Preparations are underway to begin a Phase I study with the product candidate.
ANIMAL HEALTH
Paccal® Vet
In August 2010, Oasmia submitted an application of registration for Paccal® Vet in the EU and the USA for treatment of mastocytoma in dogs. Oasmia is expecting information about a market approval from the EMA in the near future and from the FDA in the spring of 2012.
In June 2011, Paccal® Vet was granted a MUMS-designation (minor use/minor species) by the FDA for squamous cell carcinoma. The product candidate also holds this designation for mastocytoma. MUMS is granted by the FDA for either a minor use within a numerous species (such as dogs) or for treatment of a minor species. The most interesting aspect of this designation is the possibility of conditional approval with seven years of market exclusivity post-approval.
Doxophos® Vet
Doxophos® Vet is intended for treatment of lymphoma in dogs. In June 2011, Oasmia received approval from the regulatory authorities in Germany and Austria to start a Phase I study. The study started in the summer of 2011.
THE COMPANY
Oasmia carries out private placement
In October 2011, a private placement was carried out to a limited number of investors, most of which were new shareholders in the company. The number of issued shares was 5,161,290, the subscription price was SEK 9.30 and the issue provided SEK 48 million before issue expenses.
The share issue was carried out without shareholders' preferential rights supported by the authorization made by the Annual General Meeting on September 30, 2011. The new share issue increased the number of shares from 52,079,341 to 57,240,631.
The largest block, comprising 30 million, was subscribed by the company nxt2b with the principal owner Bengt Ågerup. In connection to the share issue, nxt2b acquired 2,555,500 shares from the principal owner Alceco International S.A and thereby became the second largest shareholder in Oasmia with 10.1 % of the shares and votes. Alceco International S.A held 46.2 % of the shares and votes after the share issue and sales. Nxt2b is a strategic long-term owner who shares the same vision as the principal owner and management of Oasmia.
Annual General Meeting
At the Annual General Meeting on September 30, 2011, the Board members Bo Cederstrand and Julian Aleksov were re-elected. Joel Citron, Martin Nicklasson, Jan Lundberg and Prof. Dr. Horst Domdey were elected as new members. The Board was thus expanded from five to six members. Joel Citron was elected as Chairman of the Board. The Annual General Meeting made a resolution that a Member of the Board not employed by the company shall receive remuneration of SEK 250 thousand.
The Annual General Meeting authorized the Board to, at one or more occasions until the next Annual General Meeting, decide on issues of new shares and convertibles. The total number of shares and convertibles issued may not exceed 15 million shares or entitle to conversion to more than 15 million shares. The new share issues may or may not be carried out with shareholders' preferential rights.
FINANCIAL PROSPECTS
Crucial for Oasmia's financial prospects are the registration dates for the products that the company develops. After submission of the application for registration, Oasmia is dependent on the pharmaceutical authorities' handling of the case. Oasmia tries to always have an estimation of the time of registration but cannot expedite the process in any other way than to submit answers to the authorities' questions as quickly as possible, which may be asked at various times during the registration process.
One part of Oasmia's business model is to sign license- and distribution agreements with companies which have the right resources for marketing and sales. In addition to already closed license agreements, Oasmia estimates that there are very good conditions for further licensing for interesting regions.
The company aims to launch its first product for human use, Paclical® and the first product for the veterinary market, Paccal® Vet in 2012 in one or more regions using licensees or distributors.
The company has set a goal that the debt/equity ratio shall not exceed 50 %. At the end of the period on October 31, the debt/equity ratio was 0%.
FINANCAL INFORMATION
Consolidated Income Statement in brief
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-Apr |
| Net sales | - | - | 99 | 5 | 12 |
| Capitalized development cost | 1,589 | 2,094 | 3,814 | 4,312 | 9,536 |
| Operating income | -1,483 | -1,754 | -3,186 | -2,997 | -7,131 |
| Net income after tax | -1,489 | -1,854 | -3,180 | -3,194 | -7,309 |
| Earnings per share (€), before and after dilution* | -0.03 | -0.05 | -0.06 | -0.08 | -0.17 |
| Comprehensive income for the period | -1,489 | -1,854 | -3,180 | -3,194 | -7,309 |
* 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 period amounted to € 99 thousand (5) and consisted of license revenue in connection to closing an agreement with Medison Pharma.
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 € 3,814 thousand (4,312) for the period 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.
Operating expenses
The total operating expenses excluding depreciation and impairment amounted to € 6,824 thousand (7,078). The decrease in expenses is attributable to expenses for Paccal® Vet in Phase III had all but ended at the start of the period and that expenses for Paclical® in Phase III are no longer increasing.
Of these operating expenses, 56 % (61) were capitalized as Capitalized development cost. The share of capitalized operating expenses has decreased successively since Paccal® Vet was submitted for registration in August 2010.
The number of employees was 78 (70) at the end of the period.
Income for the period
Net income for the period was € -3,180 thousand (-3,194), virtually no change compared to previous year.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Financial position
The consolidated liquid assets at the end of the period amounted to € 4,621 thousand (5). Equity at the same time amounted to € 34,437 thousand (12,520). At the end of the period, the equity/assets ratio was 91 % (52) and the debt/equity ratio 0 % (66). The company has unutilized credits amounting to SEK 45 million and an unutilized SEDA-agreement (standby equity distribution agreement) amounting to SEK 75 million.
Cash flow and Capital expenditures
Cash flow from operating activities in the period amounted to € -2,534 thousand (-1,922). The change compared to the previous year is a result of that the increase in operating liabilities was lower compared to the previous year.
Capital expenditures for the period amounted to € 4,014 thousand (5,252).
Investments in intangible assets amounted to € 3,831 thousand (4,512), consisting of capitalized development costs € 3,814 thousand and patents € 17 thousand.
Investments in property, plant and equipment amounted to € 182 thousand (741) concerning production equipment. The reason to the large decrease compared to previous year, is that the production facility in Uppsala was subject to a large upgrade in the previous year.
Financing
Financing in the period was performed by use of liquid assets. On October 31, a private placement of SEK 48 million before issue expenses was carried out.
The parent company
The parent company net sales in the period amounted to € 99 thousand (5) and net income before tax amounted to € -3,177 thousand (-3,191). The parent company liquid assets at the end of the period amounted to € 4,619 thousand (3)
Key ratios and other information
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-Apr | |
| 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 |
57,241 | 38,403 | 57,241 | 38,403 | 52,079 |
| dilution* | 52,135 | 38,403 | 52,107 | 38,403 | 44,061 |
| Earnings per share in €, before and after dilution* | -0.03 | -0.05 | -0.06 | -0.08 | -0.17 |
| Equity per share, €* | 0.60 | 0.33 | 0.60 | 0.33 | 0.63 |
| Equity/Assets ratio, % | 91 | 52 | 91 | 52 | 92 |
| Net liability, € thousand | -4,621 | 8,223 | -4,621 | 8,223 | -5,751 |
| Debt/Equity ratio, % | - | 66 | - | 66 | - |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 78 | 70 | 78 | 70 | 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
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-Apr |
| Net sales | 0 | 0 | 99 | 5 | 12 |
| Capitalized development cost | 1,589 | 2,094 | 3,814 | 4,312 | 9,536 |
| Other operating income | 0 | 8 | 5 | 11 | 30 |
| Raw materials, consumables and goods for resale | -223 | -554 | -628 | -849 | -1,786 |
| Other external expenses | -1,776 | -2,232 | -4,152 | -4,242 | -10,248 |
| Employee benefit expenses | -933 | -941 | -2,044 | -1,988 | -4,141 |
| Depreciation/amortization and impairment | -140 | -129 | -280 | -246 | -518 |
| Other operating expenses | - | 0 | - | 0 | -15 |
| Operating income | -1,483 | -1,754 | -3,186 | -2,997 | -7,131 |
| Financial income | 0 | 0 | 15 | 2 | 54 |
| Financial expenses | -6 | -100 | -9 | -199 | -232 |
| Financial items, net | -6 | -99 | 6 | -196 | -179 |
| Income before taxes | -1,489 | -1,854 | -3,180 | -3,194 | -7,310 |
| Taxes | - | 0 | - | 0 | 1 |
| Income for the period | -1,489 | -1,854 | -3,180 | -3,194 | -7,309 |
| Income for the period attributable to: | |||||
| Equity holders of the Parent company | -1,489 | -1,854 | -3,180 | -3,193 | -7,309 |
| Non-controlling interest | - | 0 | - | 0 | - |
| Earnings per share | |||||
| Before dilution, € | -0.03 | -0.05 | -0.06 | -0.08 | -0.17 |
| After dilution, € | -0.03 | -0.05 | -0.06 | -0.08 | -0.17 |
Consolidated Statement of Comprehensive income
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-Apr |
| Income for the period | -1,489 | -1,854 | -3,180 | -3,194 | -7,309 |
| Comprehensive income for the period | -1,489 | -1,854 | -3,180 | -3,194 | -7,309 |
| Comprehensive income for the period attributable to: | |||||
| Equity holders of the Parent company | -1,489 | -1,854 | -3,180 | -3,193 | -7,309 |
| Non-controlling interest | - | 0 | - | 0 | - |
| Comprehensive Earnings per share | |||||
| Before dilution, € | -0.03 | -0.05 | -0.06 | -0.08 | -0.17 |
| After dilution, € | -0.03 | -0.05 | -0.06 | -0.08 | -0.17 |
Consolidated statement of financial position
| € thousands | 2011-10-31 | 2010-10-31 | 2011-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 2,971 | 2,833 | 3,019 |
| Capitalized development cost | 28,959 | 19,921 | 25,145 |
| Other intangible assets | 995 | 1,042 | 1,028 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 32,926 | 23,797 | 29,192 |
| Current assets | |||
| Inventories | 32 | 10 | - |
| Other current receivables | 159 | 215 | 237 |
| Prepaid expenses and accrued income | 266 | 151 | 316 |
| Liquid assets | 4,621 | 5 | 5,751 |
| Total Current assets | 5,077 | 381 | 6,304 |
| TOTAL ASSETS | 38,003 | 24,178 | 35,496 |
| EQUITY | |||
| Equity attributed to equity holders in the Parent Company | |||
| Share capital | 634 | 417 | 577 |
| Other capital provided | 50,769 | 21,774 | 45,808 |
| Retained earnings | -16,966 | -9,677 | -13,787 |
| Total | 34,437 | 12,514 | 32,598 |
| Non-controlling interest | - | 6 | - |
| Total equity | 34,437 | 12,520 | 32,598 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 1,802 | 1,706 | 1,704 |
| Deferred tax liabilities | - | 1 | - |
| Total Non-current liabilities | 1,802 | 1,707 | 1,704 |
| Current liabilities | |||
| Liabilities to credit institutions | - | 549 | - |
| Short-term borrowings | - | 7,679 | - |
| Trade payables | 795 | 937 | 425 |
| Other current liabilities | 167 | 145 | 155 |
| Accrued expenses and prepaid income | 802 | 640 | 614 |
| Total Current liabilities | 1,764 | 9,951 | 1,194 |
| Total Liabilities | 3,566 | 11,658 | 2,898 |
| TOTAL EQUITY AND LIABILITIES | 38,003 | 24,178 | 35,496 |
Consolidated statement of changes in equity
| Attributable to equity holders in Parent company | ||||||||
|---|---|---|---|---|---|---|---|---|
| Other | Retained | Non-controlling | ||||||
| € thousands | Share capital | capital provided | earnings | interest | Total equity | |||
| Opening balance as of May 1, 2010 | 417 | 21,774 | -6,484 | 6 | 15,714 | |||
| Comprehensive income for the period | - | - | -3,193 | 0 | -3,194 | |||
| Closing balance as of October 31, 2010 | 417 | 21,774 | -9,677 | 6 | 12,520 | |||
| Opening balance as of May 1, 2010 | 417 | 21,774 | -6,484 | 6 | 15,714 | |||
| Comprehensive income for the period | - | - | -7,309 | - | -7,309 | |||
| Acquired non-controlling interest | - | - | 6 | -6 | 0 | |||
| New share issue | 160 | 26,291 | - | - | 26,451 | |||
| Issue expenses | - | -2,257 | - | - | -2,257 | |||
| Closing balance as of April 30, 2011 | 577 | 45,808 | -13,787 | 0 | 32,598 | |||
| Opening balance as of May 1, 2011 | 577 | 45,808 | -13,787 | 0 | 32,598 | |||
| Comprehensive income for the period | - | - | -3,180 | - | -3,180 | |||
| New share issue | 57 | 5,262 | - | - | 5,319 | |||
| Issue expenses | - | -301 | - | - | -301 | |||
| Closing balance as of October 31, 2011 | 634 | 50,769 | -16,966 | 0 | 34,437 |
Consolidated Cash flow statement
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-Apr |
| Operating activities | |||||
| Operating income before financial items | -1,483 | -1,754 | -3,186 | -2,997 | -7,131 |
| Depreciation/amortization | 140 | 129 | 280 | 246 | 515 |
| Impairment of inventory | - | - | - | - | 10 |
| Disposals of intangible assets | - | 0 | - | 0 | 15 |
| Interest received | 0 | 0 | 15 | 2 | 54 |
| Interest paid | -6 | -100 | -9 | -199 | -154 |
| Cash flow from operating activities before working | |||||
| capital changes | -1,349 | -1,725 | -2,900 | -2,947 | -6,691 |
| Change in working capital | |||||
| Change in inventories | -32 | - | -32 | - | - |
| Change in trade receivables | - | - | - | 7 | 7 |
| Change in other current receivables | -11 | -85 | 129 | 138 | -49 |
| Change in trade payables | 236 | 869 | 370 | 707 | 195 |
| Change in other current liabilities | -166 | 25 | -101 | 173 | 157 |
| Cash flow from operating activities | -1,322 | -916 | -2,534 | -1,922 | -6,383 |
| Investing activities | |||||
| Investments in intangible fixed assets | -1,589 | -2,293 | -3,831 | -4,512 | -9,790 |
| Investments in property, plant and equipment | -17 | -423 | -182 | -741 | -1,144 |
| Cash flow from investing activities | -1,605 | -2,716 | -4,014 | -5,252 | -10,933 |
| Financing activities | |||||
| Increase in liabilities to credit institutions | - | - | - | 74 | - |
| Decrease in liabilities to credit institutions | - | -3 | - | - | -475 |
| Increase in long-term liabilities | - | - | 99 | - | - |
| New share issue | 5,319 | - | 5,319 | - | 18,694 |
| Issue expenses | - | - | - | - | -2,257 |
| New loans | - | 3,629 | - | 6,510 | 6,510 |
| Cash flow from financing activities | 5,319 | 3,625 | 5,418 | 6,584 | 22,471 |
| Cash flow for the period | 2,392 | -7 | -1,130 | -591 | 5,155 |
| Cash and cash equivalents at the beginning of the period | 2,229 | 12 | 5,751 | 595 | 595 |
| Cash and cash equivalents at the end of the period | 4,621 | 5 | 4,621 | 5 | 5,751 |
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - October 2011
THE PERIOD May 1– October 31, 2011
- Consolidated net sales amounted to TSEK 891 (42)2
- Operating income amounted to TSEK -28 752 (-27 047)
- Net income after tax amounted to TSEK -28 696 (-28 819)
- Earnings per share was SEK -0,55 (-0,75)
- Comprehensive income amounted to TSEK -28 696 (-28 819)
SECOND QUARTER August 1– October 31, 2011
- Consolidated net sales amounted to TSEK 0 (0) 3
- Operating income amounted to TSEK -13 384 (-15 832)
- Net income after tax amounted to TSEK -13 435 (-16 729)
- Earnings per share was SEK -0,26 (-0,44)
- Comprehensive income amounted to TSEK -13 435 (-16 729)
- Oasmia carries out a SEK 48 million private placement with a new strategic owner
- Enrolment of 650 patients complete in Phase III study with Paclical®
- The Annual General Meeting elected Joel Citron, Martin Nicklasson, Jan Lundberg and Prof. Dr Horst Domdey as Members of the Board
- The Annual General Meeting made a resolution of authorization corresponding to 15 million shares
- Oasmia and Orion concluded Paclical® collaboration in the Nordics
2 The numbers in parentheses concerns results for the corresponding period previous year
3 The numbers in parentheses concerns results for the corresponding period previous year
BUSINESS ACTIVTIES IN THE PERIOD
HUMAN HEALTH
Paclical®
The enrolment of 650 patients in the Phase III study with Paclical® on ovarian cancer was completed in September 2011.
In August 2011, the result was reported from an interim analysis which comprised of about 400 of the 650 patients. The result fulfilled the placed clinical requirement, that Paclical® should be at least as effective as Taxol®.
Important differences between treatments with these two drugs are as follows:
- Extensive premedication is necessary for Taxol® in order to avoid hypersensitivity reactions due to the solvent Cremophor® EL. This is not necessary for Paclical®.
- The infusion time for Paclical® is one hour and three hours for Taxol®.
- Paclical® can be administered in a higher dose (250 mg/m2 ) compared to Taxol® (175 mg/m2 )
The work with the interim analysis has continued in the period concerning other variables which will be included in the application for market authorization.
Oasmia plans to submit applications for market approval for Paclical® in EU, Russia, Israel, Turkey and a few countries in Asia in the beginning of 2012.
The next step for the company after enrolment and treatment of the 650 patients which comprise the study is to evaluate when survival data, an important factor in oncology studies, can be analyzed. The process to determine the number of patients required to obtain such data in a reasonable time is ongoing.
In August 2011, Oasmia and Orion concluded the collaboration for Paclical® and all rights were returned to Oasmia.
In May 2011, a license agreement was closed with Medison Pharma for Paclical® in Israel and Turkey.
Paclical® is previously designated as an orphan drug by the EMA (EU) and the FDA (USA) on the indication ovarian cancer. Orphan Drug designation is granted for minor indications and entails market exclusivity for seven years in the USA and for ten years in the EU on the indication when a market approval has been obtained.
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 20 different types of cancer. Pre-clinical studies have been completed with Doxophos®, and based on this, Oasmia previously planned to start a clinical Phase I study in 2011. The start of the study has been postponed to the first quarter 2012 in order to focus on Paclical® concerning interim analysis and application for market approval.
Docecal®
Docecal® is a new patented formulation of docetaxel (Taxotere®) with improved chemical properties compared to Taxotere®. Oasmia intends to focus on the same indications as Taxotere®, i.e. breast cancer, prostate cancer and non-small cell lung cancer. Preparations are underway to begin a Phase I study with the product candidate.
ANIMAL HEALTH
Paccal® Vet
In August 2010, Oasmia submitted an application of registration for Paccal® Vet in the EU and the USA for treatment of mastocytoma in dogs. Oasmia is expecting information about a market approval from the EMA in the near future and from the FDA in the spring of 2012.
In June 2011, Paccal® Vet was granted a MUMS-designation (minor use/minor species) by the FDA for squamous cell carcinoma. The product candidate also holds this designation for mastocytoma. MUMS is granted by the FDA for either a minor use within a numerous species (such as dogs) or for treatment of a minor species. The most interesting aspect of this designation is the possibility of conditional approval with seven years of market exclusivity post-approval.
Doxophos® Vet
Doxophos® Vet is intended for treatment of lymphoma in dogs. In June 2011, Oasmia received approval from the regulatory authorities in Germany and Austria to start a Phase I study. The study started in the summer of 2011.
THE COMPANY
Oasmia carries out private placement
In October 2011, a private placement was carried out to a limited number of investors, most of which were new shareholders in the company. The number of issued shares was 5,161,290, the subscription price was SEK 9.30 and the issue provided SEK 48 million before issue expenses.
The share issue was carried out without shareholders' preferential rights supported by the authorization made by the Annual General Meeting on September 30, 2011. The new share issue increased the number of shares from 52,079,341 to 57,240,631.
The largest block, comprising 30 million, was subscribed by the company nxt2b with the principal owner Bengt Ågerup. In connection to the share issue, nxt2b acquired 2,555,500 shares from the principal owner Alceco International S.A and thereby became the second largest shareholder in Oasmia with 10.1 % of the shares and votes. Alceco International S.A held 46.2 % of the shares and votes after the share issue and sales. Nxt2b is a strategic long-term owner who shares the same vision as the principal owner and management of Oasmia.
Annual General Meeting
At the Annual General Meeting on September 30, 2011, the Board members Bo Cederstrand and Julian Aleksov were re-elected. Joel Citron, Martin Nicklasson, Jan Lundberg and Prof. Dr. Horst Domdey were elected as new members. The Board was thus expanded from five to six members. Joel Citron was elected as Chairman of the Board. The Annual General Meeting made a resolution that a Member of the Board not employed by the company shall receive remuneration of SEK 250 thousand.
The Annual General Meeting authorized the Board to, at one or more occasions until the next Annual General Meeting, decide on issues of new shares and convertibles. The total number of shares and convertibles issued may not exceed 15 million shares or entitle to conversion to more than 15 million shares. The new share issues may or may not be carried out with shareholders' preferential rights.
FINANCIAL PROSPECTS
Crucial for Oasmia's financial prospects are the registration dates for the products that the company develops. After submission of the application for registration, Oasmia is dependent on the pharmaceutical authorities' handling of the case. Oasmia tries to always have an estimation of the time of registration but cannot expedite the process in any other way than to submit answers to the authorities' questions as quickly as possible, which may be asked at various times during the registration process.
One part of Oasmia's business model is to sign license- and distribution agreements with companies which have the right resources for marketing and sales. In addition to already closed license agreements, Oasmia estimates that there are very good conditions for further licensing for interesting regions.
The company aims to launch its first product for human use, Paclical® and the first product for the veterinary market, Paccal® Vet in 2012 in one or more regions using licensees or distributors.
The company has set a goal that the debt/equity ratio shall not exceed 50 %. At the end of the period on October 31, the debt/equity ratio was 0%.
FINANCAL INFORMATION
Consolidated Income Statement in brief
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | - | - | 891 | 42 | 106 |
| Capitalized development cost | 14 336 | 18 896 | 34 420 | 38 913 | 86 049 |
| Operating income | -13 384 | -15 832 | -28 752 | -27 047 | -64 353 |
| Net income after tax | -13 435 | -16 729 | -28 696 | -28 819 | -65 960 |
| Earnings per share (SEK), before and after dilution* | -0,26 | -0,44 | -0,55 | -0,75 | -1,50 |
| Comprehensive income for the period | -13 435 | -16 729 | -28 696 | -28 819 | -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 period amounted to TSEK 891 (42) and consisted of license revenue in connection to closing an agreement with Medison Pharma.
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 34 420 (38 913) for the period 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.
Operating expenses
The total operating expenses excluding depreciation and impairment amounted to TSEK 61 578 (63 876). The decrease in expenses is attributable to expenses for Paccal® Vet in Phase III had all but ended at the start of the period and that expenses for Paclical® in Phase III are no longer increasing.
Of these operating expenses, 56 % (61) were capitalized as Capitalized development cost. The share of capitalized operating expenses has decreased successively since Paccal® Vet was submitted for registration in August 2010.
The number of employees was 78 (70) at the end of the period.
Income for the period
Net income for the period was TSEK -28 696 (-28 819), virtually no change compared to previous year.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Financial position
The consolidated liquid assets at the end of the period amounted to TSEK 41 696 (42). Equity at the same time amounted to TSEK 310 761 (112 984). At the end of the period, the equity/assets ratio was 91 % (52) and the debt/equity ratio 0 % (66). The company has unutilized credits amounting to TSEK 45 000 and 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 period amounted to TSEK -22 869 (-17 346). The change compared to the previous year is a result of that the increase in operating liabilities was lower compared to the previous year.
Capital expenditures for the period amounted to TSEK 36 221 (47 396).
Investments in intangible assets amounted to TSEK 34 575 (40 713), consisting of capitalized development costs TSEK 34 420 and patents TSEK 155.
Investments in property, plant and equipment amounted to TSEK 1 646 (6 684) concerning production equipment. The reason to the large decrease compared to previous year, is that the production facility in Uppsala was subject to a large upgrade in the previous year.
Financing
Financing in the period was performed by use of liquid assets. On October 31, a private placement of SEK 48 million before issue expenses was carried out.
The parent company
The parent company net sales in the period amounted to TSEK 891 (42) and net income before tax amounted to TSEK -28 670 (-28 796). The parent company liquid assets at the end of the period amounted to TSEK 41 682 (31).
Key ratios and other information
| 2011 | 2010 | 2011 | 2010 | 2010/11 | |
|---|---|---|---|---|---|
| Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April | |
| Number of shares at the close of the period (in thousands), before and | |||||
| after dilution* | 57 241 | 38 403 | 57 241 | 38 403 | 52 079 |
| Weighted average number of shares (in thousands) before and after | |||||
| dilution* | 52 135 | 38 403 | 52 107 | 38 403 | 44 061 |
| Earnings per share in SEK, before and after dilution* | -0,26 | -0,44 | -0,55 | -0,75 | -1,50 |
| Equity per share, SEK* | 5,43 | 2,94 | 5,43 | 2,94 | 5,65 |
| Equity/Assets ratio, % | 91 | 52 | 91 | 52 | 92 |
| Net liability, TSEK | -41 696 | 74 209 | -41 696 | 74 209 | -51 895 |
| Debt/Equity ratio, % | - | 66 | - | 66 | - |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 78 | 70 | 78 | 70 | 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
| 2011 | 2010 | 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | - | - | 891 | 42 | 106 | |
| Capitalized development cost | 14 336 | 18 896 | 34 420 | 38 913 | 86 049 | |
| Other operating income | - | 72 | 42 | 99 | 269 | |
| Raw materials, consumables and goods for resale | -2 012 | -4 998 | -5 663 | -7 660 | -16 120 | |
| Other external expenses | -16 027 | -20 146 | -37 469 | -38 279 | -92 479 | |
| Employee benefit expenses | -8 417 | -8 495 | -18 445 | -17 938 | -37 370 | |
| Depreciation/amortization and impairment | -1 265 | -1 161 | -2 527 | -2 224 | -4 674 | |
| Other operating expenses | - | -1 | - | -1 | -133 | |
| Operating income | -13 384 | -15 832 | -28 752 | -27 047 | -64 353 | |
| Financial income | 1 | 2 | 133 | 21 | 484 | |
| Financial expenses | -53 | -899 | -77 | -1 792 | -2 097 | |
| Financial items, net | -51 | -897 | 56 | -1 772 | -1 613 | |
| Income before taxes | -13 435 | -16 729 | -28 696 | -28 819 | -65 967 | |
| Taxes | 2 | - | 0 | - | 0 | 7 |
| Income for the period | -13 435 | -16 729 | -28 696 | -28 819 | -65 960 | |
| Income for the period attributable to: | ||||||
| Equity holders of the Parent company | -13 435 | -16 728 | -28 696 | -28 816 | -65 960 | |
| Non-controlling interest | - | -1 | - | -2 | - | |
| Earnings per share | ||||||
| Before dilution, SEK | -0,26 | -0,44 | -0,55 | -0,75 | -1,50 | |
| After dilution, SEK | -0,26 | -0,44 | -0,55 | -0,75 | -1,50 | |
| Consolidated Statement of Comprehensive |
income
| 2011 | 2010 | 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Income for the period | -13 435 | -16 729 | -28 696 | -28 819 | -65 960 | |
| Comprehensive income for the period | -13 435 | -16 729 | -28 696 | -28 819 | -65 960 | |
| Comprehensive income for the period attributable to: | ||||||
| Equity holders of the Parent company | -13 435 | -16 728 | -28 696 | -28 816 | -65 960 | |
| Non-controlling interest | - | -1 | - | -2 | - | |
| Comprehensive Earnings per share | ||||||
| Before dilution, SEK | -0,26 | -0,44 | -0,55 | -0,75 | -1,50 | |
| After dilution, SEK | -0,26 | -0,44 | -0,55 | -0,75 | -1,50 |
Consolidated statement of financial position
| TSEK | Note | 2011-10-31 | 2010-10-31 | 2011-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 26 814 | 25 565 | 27 243 | |
| Capitalized development cost | 3 | 261 330 | 179 773 | 226 909 |
| Other intangible assets | 8 977 | 9 406 | 9 276 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 297 123 | 214 745 | 263 430 | |
| Current assets | ||||
| Inventories | 290 | 94 | - | |
| Other current receivables | 1 432 | 1 938 | 2 141 | |
| Prepaid expenses and accrued income | 2 400 | 1 366 | 2 853 | |
| Liquid assets | 41 696 | 42 | 51 895 | |
| Total Current assets | 45 818 | 3 441 | 56 889 | |
| TOTAL ASSETS | 342 941 | 218 186 | 320 319 | |
| EQUITY | ||||
| Equity attributed to equity holders in the Parent Company | ||||
| Share capital | 5 724 | 3 761 | 5 208 | |
| Other capital provided | 458 144 | 196 493 | 413 375 | |
| Retained earnings | -153 107 | -87 325 | -124 411 | |
| Total | 310 761 | 112 930 | 294 171 | |
| Non-controlling interest | - | 55 | - | |
| Total equity | 310 761 | 112 984 | 294 171 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 16 264 | 15 397 | 15 373 | |
| Deferred tax liabilities | - | 7 | - | |
| Total Non-current liabilities | 16 264 | 15 404 | 15 373 | |
| Current liabilities | ||||
| Liabilities to credit institutions | - | 4 956 | - | |
| Short-term borrowings | 4 | - | 69 295 | - |
| Trade payables | 7 170 | 8 455 | 3 831 | |
| Other current liabilities | 1 511 | 1 312 | 1 399 | |
| Accrued expenses and prepaid income | 7 234 | 5 780 | 5 545 | |
| Total Current liabilities | 15 916 | 89 798 | 10 775 | |
| Total Liabilities | 32 180 | 105 202 | 26 148 | |
| TOTAL EQUITY AND LIABILITIES | 342 941 | 218 186 | 320 319 | |
| Contingent liabilities | 5 | |||
| Pledged assets | 5 |
Consolidated statement of changes in equity
| Attributable to equity holders in Parent company |
||||||
|---|---|---|---|---|---|---|
| TSEK | Share capital | Other capital provided |
Retained earnings |
Non controlling interest |
Total equity | |
| Opening balance as of May 1, 2010 | 3 761 | 196 493 | -58 509 | 57 | 141 803 | |
| Comprehensive income for the period Closing balance as of October 31, 2010 |
- 3 761 |
- 196 493 |
-28 816 -87 325 |
-2 55 |
-28 819 112 984 |
|
| 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 Closing balance as of April 30, 2011 |
- 5 208 |
-20 369 413 375 |
- -124 411 |
- 0 |
-20 369 294 171 |
|
| Opening balance as of May 1, 2011 | 5 208 | 413 375 | -124 411 | 0 | 294 171 | |
| Comprehensive income for the period | - | - | -28 696 | - | -28 696 | |
| New share issue | 516 | 47 484 | - | - | 48 000 | |
| Issue expenses | - | -2 714 | - | - | -2 714 | |
| Closing balance as of October 31, 2011 | 5 724 | 458 144 | -153 107 | 0 | 310 761 | |
| Consolidated Cash flow statement | ||||||
| 2011 | 2010 | 2011 | 2010 | 2010/11 | ||
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Operating activities | ||||||
| Operating income before financial items | -13 384 | -15 832 | -28 752 | -27 047 | -64 353 | |
| Depreciation/amortization | 1 265 | 1 161 | 2 527 | 2 224 | 4 650 | |
| Impairment of inventory | - | - | - | - | 94 | |
| Disposals of intangible assets | - | 1 | - | 1 | 133 | |
| Interest received | 1 | 2 | 133 | 21 | 484 | |
| Interest paid | -53 | -899 | -77 | -1 792 | -1 392 | |
| Cash flow from operating activities before working capital changes |
-12 170 | -15 567 | -26 168 | -26 594 | -60 385 | |
| Change in working capital | ||||||
| Change in inventories | -290 | - | -290 | - | - | |
| Change in trade receivables | - | - | - | 60 | 60 | |
| Change in other current receivables | -95 | -769 | 1 162 | 1 245 | -445 | |
| Change in trade payables | 2 126 | 7 843 | 3 339 | 6 379 | 1 756 | |
| Change in other current liabilities | -1 501 | 224 | -912 | 1 563 | 1 415 | |
| Cash flow from operating activities | -11 930 | -8 269 | -22 869 | -17 346 | -57 598 | |
| Investing activities | ||||||
| Investments in intangible fixed assets | -14 336 | -20 696 | -34 575 | -40 713 | -88 342 | |
| Investments in property, plant and equipment | -149 | -3 816 | -1 646 | -6 684 | -10 321 | |
| Cash flow from investing activities | -14 486 | -24 512 | -36 221 | -47 396 | -98 663 | |
| Financing activities | ||||||
| Increase in liabilities to credit institutions | - | - | - | 667 | - | |
| Decrease in liabilities to credit institutions | - | -29 | - | - | -4 289 | |
| Increase in long-term liabilities | - | - | 891 | - | - | |
| New share issue | 48 000 | - | 48 000 | - | 168 697 | |
| Issue expenses | - | - | - | - | -20 369 | |
| New loans | 4 | - | 32 745 | - | 58 745 | 58 745 |
| Cash flow from financing activities | 48 000 | 32 716 | 48 891 | 59 412 | 202 784 | |
| Cash flow for the period Cash and cash equivalents at the beginning of |
21 585 | -65 | -10 199 | -5 330 | 46 523 | |
| the period | 20 112 | 107 | 51 895 | 5 372 | 5 372 | |
| Cash and cash equivalents at the end of the period |
41 696 | 42 | 41 696 | 42 | 51 895 |
Parent Company Income statement
| 2011 | 2010 | 2011 | 2010 | 2010/11 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | - | - | 891 | 42 | 106 | |
| Capitalized development cost | 14 336 | 18 896 | 34 420 | 38 913 | 86 049 | |
| Other operating income | - | 72 | 42 | 99 | 245 | |
| Raw materials, consumables and goods for resale | -2 012 | -4 987 | -5 663 | -7 620 | -16 080 | |
| Other external expenses | -15 987 | -20 094 | -37 393 | -38 175 | -92 271 | |
| Employee benefit expenses | -8 417 | -8 495 | -18 445 | -17 938 | -37 370 | |
| Depreciation/amortization and impairment of property, plant, equipment and intangible assets |
-1 244 | -1 118 | -2 478 | -2 135 | -4 486 | |
| Operating income | -13 323 | -15 725 | -28 626 | -26 814 | -63 806 | |
| Result from participations in Group companies | 4 | -100 | -60 | -100 | -210 | -578 |
| Other interest revenues and similar revenues | 1 | 1 | 133 | 20 | 483 | |
| Interest cost and similar costs | -53 | -899 | -77 | -1 792 | -2 097 | |
| Financial items, net | -151 | -957 | -44 | -1 981 | -2 192 | |
| Income after financial items | -13 474 | -16 683 | -28 670 | -28 796 | -65 998 | |
| Taxes | 2 | - | - | - | - | - |
| Income for the period | -13 474 | -16 683 | -28 670 | -28 796 | -65 998 |
Parent Company Balance Sheet
| TSEK | Note | 2011-10-31 | 2010-10-31 | 2011-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost | 3 | 261 330 | 179 773 | 226 909 |
| Concessions, patents, licenses, trademarks and | ||||
| similar rights | 8 931 | 9 079 | 9 180 | |
| Property, plant and equipment | ||||
| Equipment, tools, fixtures and fittings | 25 460 | 25 565 | 27 243 | |
| Advance payments for property, plant and equipment | 1 355 | - | - | |
| Financial assets Participations in group companies |
110 | 298 | 110 | |
| Receivables from group companies | 6 | 4 | 5 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 297 192 | 214 719 | 263 448 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 290 | 94 | - | |
| 290 | 94 | 0 | ||
| Current receivables | ||||
| Receivables from group companies | 4 | 2 | 99 | 89 |
| Other current receivables | 1 431 | 1 936 | 2 140 | |
| Prepaid expenses and accrued income | 2 375 | 1 335 | 2 748 | |
| 3 807 | 3 369 | 4 977 | ||
| Cash and bank balances | 41 682 | 31 | 51 884 | |
| Total current assets | 45 779 | 3 494 | 56 861 | |
| TOTAL ASSETS | 342 971 | 218 212 | 320 309 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 5 724 | 3 761 | 5 208 | |
| Statutory reserve | 4 620 | 4 620 | 4 620 | |
| 10 344 | 8 381 | 9 828 | ||
| Non-restricted equity | ||||
| Share premium reserve | 458 144 | 196 493 | 413 375 | |
| Retained earnings | -129 028 | -63 030 | -63 030 | |
| Income for the period | -28 670 | -28 796 | -65 998 | |
| 300 447 | 104 668 | 284 347 | ||
| Total equity | 310 791 | 113 049 | 294 175 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 16 264 | 15 373 | 15 373 | |
| Total non-current liabilities | 16 264 | 15 373 | 15 373 | |
| Current liabilities | ||||
| Short term borrowings | 4 | - | 69 295 | - |
| Trade payables | 7 170 | 8 447 | 3 818 | |
| Liabilities to Credit institutions | - | 4 956 | - | |
| Other current liabilities | 1 511 | 1 312 | 1 399 | |
| Accrued expenses and prepaid income | 7 234 | 5 780 | 5 545 | |
| Total Current liabilities | 15 916 | 89 790 | 10 761 | |
| TOTAL EQUITY AND LIABILITIES | 342 971 | 218 212 | 320 309 | |
| Contingent liabilities and pledged assets | ||||
| Contingent liabilities | 5 | - | - | - |
| Pledged assets | 5 | 8 000 | 5 000 | 8 000 |
Parent Company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| TSEK | Share capital | Statutory reserve |
Non restricted equity |
Total equity |
| Opening balance as of May 1, 2010 | 3 761 | 4 620 | 133 464 | 141 845 |
| Income for the period | - | - | -28 796 | -28 796 |
| Closing balance as of October 31, 2010 | 3 761 | 4 620 | 104 668 | 113 049 |
| 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 | - | - | -2 714 | -2 714 |
| Income for the period | - | - | -28 670 | -28 670 |
| Closing balance as of October 31, 2011 | 5 724 | 4 620 | 300 447 | 310 791 |
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 191 471 (125 773) and the Parent Company has similar amounting to TSEK 182 147 (116 882). 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 | 2011-10-31 | 2010-10-31 | 2011-04-30 |
|---|---|---|---|
| Paclical® | 180 278 | 108 707 | 145 858 |
| Paccal® Vet | 81 051 | 71 066 | 81 051 |
| Total | 261 330 | 179 773 | 226 909 |
Note 4 Transactions with related parties
The principal owner Alceco International S.A has provided Oasmia with a credit facility amounting to MSEK 40. The credit facility is valid until August 2012 and is automatically extended with 12 months if the credit is not cancelled by either party 3 months before the term expiration date at the latest. The interest rate on utilized credits amounts to 6 %. As of October 31, 2011, the company had no liabilities to Alceco International S.A. (As of October 31, 2010, the company used credit facilities amounting to TSEK 69 295 of provided credit from Alceco International S.A.)
Oasmias claim in the subsidiary Qdoxx Pharma AB amounted as of closing day to TSEK 2 (99). Oasmia has made a group contribution to Qdoxx Pharma amounting to TSEK 100 (210) in the period, where TSEK 100 (60) was contributed in the second quarter. Impairments of shares in Qdoxx Pharma AB has been made in the period corresponding to the group contribution, as the purpose of the group contributions was to cover losses in the subsidiary. 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 CEO of Oasmia Pharmaceutical AB ensures that this Interim report gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group faces.
Uppsala, December 8, 2011
| Joel Citron, Chairman | Martin Nicklasson, Member |
|---|---|
| Jan Lundberg, Member | Prof. Dr. Horst Domdey, Member |
| Bo Cederstrand, Member | Julian Aleksov, Member and Chief Executive Officer |
The information in this Interim report is such that Oasmia Pharmaceutical (publ) must publish according to the code of trade in financial instruments. The information was delivered for publication on December 8, 2011 at 09.00.
This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.
Review Report
To the Board of Directors of Oasmia Pharmaceutical AB, corp id 556332-6676
Introduction
We reviewed the accompanying condensed balance sheet of Oasmia Pharmaceutical AB as of October 31, 2011 and the related condensed summary of income, changes in equity and cash-flows for the six-month period then ended. The Board of Directors and the Managing Director are responsible for the preparation and fair presentation of this condensed interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this condensed interim financial information based on our review.
Scope of Review
We conducted our review in accordance with the Standard on Review Engagements, SÖG 2410, "Review of Interim Financial Statements Performed by the Independent Auditor of the Entity", issued by the Swedish Federation of Authorized Public Accountants. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the accompanying condensed interim financial information does not give a true and fair view of the financial position of the entity as at October 31, 2011, and its financial performance and its cash flows for the six-month period then ended, for the group in accordance with IAS 34 and the Swedish Annual Accounts Act and for the parent company in accordance with the Swedish Annual Accounts Act.
Uppsala December 8, 2011
Ernst & Young AB Björn Ohlsson
Authorized Public Accountant
COMPANY INFORMATION
Oasmia Pharmaceutical AB (publ) VAT-number: SE556332-667601 Seat: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
KOMMANDE RAPPORTTILLFˆLLEN
| Interim Report May 2011 – January 2012 | 2012-03-08 |
|---|---|
| Year-end report May 2011 – April 2012 | 2012-06-14 |
| Annual Report May 2011 – April 2012 | 2012-08-23 |
| Interim report May – July 2012 | 2012-09-06 |
About Oasmia Pharmaceutical AB
OasmiaPharmaceutical 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 p roperties, 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 Exchan ge.