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Vivesto — Interim / Quarterly Report 2014
Dec 5, 2013
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Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for the period May - October 2013 €
Page 1-10 is a service to shareholders in the euro zone. It is not the official report in the functional currency of Oasmia, which is SEK, but the first ten pages of that report converted to EUR. The full official report will be found on pages 11-26. 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, 2013 which was 8.8025 SEK per one EUR. When occasional figures are in SEK or USD it is because the amount is very firmly denominated in that currency.
THE PRE-CLINICAL AND CLINICAL PROGRAMS FOR THE DEVELOPMENT OF NEW PHARMACEUTICALS CONTINUE
SECOND QUARTER August 1 – October 31, 2013
- Consolidated Net sales amounted to € 3 thousand (0)1
- Operating income amounted to € -1,974 thousand (-1,469)
- Net income after tax amounted to € -2,120 thousand (-1,655)
- Earnings per share amounted to € -0.03 (-0.03)
- Comprehensive income amounted to € -2,120 thousand (-1,655)
THE PERIOD May 1 – October 31, 2013
- Consolidated Net sales amounted to € 3 thousand (0)
- Operating income amounted to € -3,903 thousand (-3,552)
- Net income after tax amounted to € -4,190 thousand (-3,850)
- Earnings per share amounted to € -0.05 (-0.07)
- Comprehensive income amounted to € -4,190 thousand (-3,850)
- Oasmia initiated a clinical program for Paclical for treatment of breast cancer
- Oasmia initiated pre-clinical studies with OAS-19, the first pharmaceutical project with a combination of two active cytostatics in one infusion
The numbers in brackets concern results from the corresponding period of the previous year
EVENTS AFTER CLOSING DAY
- Increased funding through extension of MSEK 105 loan from Nexttobe and a new MSEK 40 bank loan
- Oasmia Announces Successful FDA Pre-Approval Inspection of Its Manufacturing Facility
CEO COMMENTS:
"During the second quarter we continued to work with both pre-clinical and clinical studies of our prioritized projects. Also, we have noted a continued interest for our patented technology platform XR-17 among other pharmaceutical companies looking for an excipient for their projects with insoluble pharmaceuticals", says CEO Julian Aleksov.
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 the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
HUMAN HEALTH
Oasmia's research and development in human health is mainly focused on the indications ovarian cancer and breast cancer.
Paclical®
Paclical® is a patented formulation of the commonly used cytostatic paclitaxel in combination with Oasmia's patented technology XR-17. Paclical® is designated as an orphan drug (see below) in EU and USA for the indication ovarian cancer.
Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer, an indication with 225,000 annual new cases globally. The total number of patients in the study is 789, and the final patient was treated in the beginning of 2013. All patients are now being followed up regarding time to progression. Oasmia is now closing the study in order to evaluate the results. The results will be used for submission of marketing authorization applications for Paclical® in the EU, the US and RoW for the treatment of ovarian cancer.
Oasmia initiated in the summer of 2013 a clinical dose-finding study with Paclical for weekly treatment of breast cancer.
In September 2012, Oasmia submitted an application for market authorization for Paclical® in Russia, which is currently being processed by the Russian pharmaceutical authority.
Doxophos®
Doxophos® is a patented formulation of doxorubicin in combination with XR-17. Doxorubicin is one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation for this product candidate and is now planning the clinical program.
Docecal®
Docecal® is a patented formulation of the cytostatic docetaxel in combination with XR-17. Oasmia has initiated the validation process for manufacture of Docecal® , and is preparing a clinical program for the product candidate.
OAS-19
OAS-19 is the first oncology product candidate to apply a dual cytostatic agent encapsulation and release mechanism in one infusion. It is the unique properties in XR-17 that make this combination possible. This concept
provides Oasmia with one more dimension for pharmaceutical development of multiple active substances in one micelle where also substances with different solubility can be combined. Recent pre-clinical studies have shown promising results, and the company plans to start clinical studies with OAS-19 in 2014.
Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (USA) years on the indication, when the drug is approved for market.
ANIMAL HEALTH
Product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs. The company is focusing on two common indications, mastocytoma and lymphoma, which comprise about half of all cancers in dogs. Product development has made it possible to expand the range of indications to include also mammary carcinoma and squamous cell carcinoma.
Paccal® Vet
Paccal® Vet is a patented formulation of paclitaxel, in combination with XR-17.
Oasmia has submitted an application to the American Food and Drug Administration (FDA) for market authorization of Paccal® Vet for treatment of mammary carcinoma and squamous cell carcinoma. Oasmia is expecting response from the FDA.
The indications for which an application has been submitted to the FDA have previously been granted MUMS designation (see below) by the FDA.
Oasmia has an ongoing study with Paccal® Vet for treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs who has been treated four times with three-week intervals. When data have been collected and analysed, Oasmia intends to file an application for market approval for Paccal® Vet to the European authority EMA.
Doxophos® Vet
Doxophos® Vet is a patented formulation of doxorubicin in combination with XR-17. Oasmia is developing Doxophos® Vet for treatment of lymphoma (lymph node cancer), which is one of the most common cancer indications in dogs. Doxophos® Vet has been granted a MUMS designation (see below) in the USA for the indication lymphoma.
Oasmia conducts a Phase I study for Doxophos® Vet in order to establish the dose for the clinical program.
BOLAGET MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
Annual General Meeting 2013
At the Annual General Meeting in September 2013, the Board of Directors was re-elected and Alexander Kotsinas was elected as a new Member of the Board. Alexander Kotsinas is a member of the management of the investment company Nexttobe, the second largest shareholder in Oasmia.
Warrants
At the Annual General Meeting in September it was decided that the Board of Directors and management should have the right to purchase warrants in Oasmia Pharmaceutical AB. In October, the maximum number of warrants 1 050 000, was issued from the parent company to the subsidiary Oasmia Animal Health AB. The subsidiary has the right and the obligation to sell the warrants to the Board of Directors and to management. For further details about conditions, see communiqué from the AGM on Oasmia´s website. As per October 31, no purchases of warrants had been executed.
Share price development during 2013 (SEK)
EVENTS AFTER CLOSING DAY
Increased funding through extension of MSEK 105 loan from Nexttobe and a new MSEK 40 bank loan The existing loan from Nexttobe was extended by one year, from December 31, 2013 to December 31, 2014. The current interest of 5 % will be 8.5 % in 2014. The interest will be paid in full on December 31, 2014. Furthermore, Oasmia was granted a new MSEK 40 bank loan with a term from December 1, 2013 to March 31, 2014.
Oasmia successfully passed an FDA Pre-Approval Inspection of Its Manufacturing Facility The Swedish pharmaceutical company Oasmia Pharmaceutical AB (publ), listed on Nasdaq OMX in Stockholm and the Frankfurt Stock Exchange, announced on December 3, that its manufacturing facility in Uppsala, Sweden, has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA). With this inspection, the FDA confirmed that Oasmia's manufacturing facility with respect to Paccal® Vet (paclitaxel) meets the requirements of Current Good Manufacturing Practice (cGMP).
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
|---|---|---|---|---|---|
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 3 | - | 3 | - | - |
| Capitalized development cost | 816 | 1,976 | 1,591 | 3,088 | 5,525 |
| Operating income | -1,974 | -1,469 | -3,903 | -3,552 | -7,678 |
| Net income after tax | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Earnings per share (€), before and after dilution* | -0.03 | -0.03 | -0.05 | -0.07 | -0.12 |
| Comprehensive income for the period | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
SECOND QUARTER
August 1 – October 31, 2013
Net sales
Net sales amounted to € 3 thousand (-).
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to € 816 thousand (1,976). The larger part concerned Paclical® which was capitalized with € 466 thousand (1,950) and a smaller part concerning Paccal® Vet which contributed with € 350 thousand (26). The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials for Paclical® .
Operating expenses
Operating expenses excluding depreciation and impairment were significantly lower compared to the previous year and amounted to € 2,658 thousand (3,309). The decrease was due to that the clinical trial with Paclical for treatment of ovarian cancer was near completion.
Income for the quarter
Net income was € -2,120 thousand (-1,655). The decrease was attributable to a lower capitalization of development costs compared to the corresponding quarter the previous year.
THE PERIOD May 1 – October 31, 2013
Net sales Net sales amounted to € 3 thousand (-).
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to € 1,591 thousand (3,088). The larger part concerned Paclical® which was capitalized with € 984 thousand (3,063) and a smaller part concerning Paccal® Vet which contributed with € 607 thousand (26). The decrease compared to the same period in the previous year is attributable to decreased costs for clinical trials for Paclical® .
Other operating income
Other operating income amounted to € 494 thousand (11) and mainly concerned an insurance compensation for a production disruption amounting to € 483 thousand.
Operating expenses
Operating expenses excluding depreciation and impairment were significantly lower compared to the previous year and amounted to € 5,710 thousand (6,361). The decrease was due to that the clinical trial with Paclical for treatment of ovarian cancer was near completion.
The number of employees at the end of the period was 79 (73).
Income for the period
Net income was € -4,190 thousand (-3,850). The decrease was attributable to a lower capitalization of development costs compared to the corresponding period in the previous year.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Cash flow and Capital expenditures
Cash flow from operating activities amounted to € -4,048 thousand (3,954).
Cash flow from investing activities amounted to € -1,871 thousand (-4,778). The decreased level of investments concerned capitalized development costs and other intangible assets and property, plant and equipment.
Of these, investments in intangible assets amounted to € 1,864 thousand (4,292), consisting of capitalized development costs € 1,591 thousand (3,088) and patents and other intangible assets € 273 thousand (1,204).
Of these, only € 7 thousand (486) were investments in property, plant and equipment.
Financing
Financing in the period was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012. The liquid assets were strengthened by an insurance compensation.
Financial position
The consolidated liquid assets at the end of the period amounted to € 1,233 thousand (229). The interest-bearing liabilities were € 11,928 thousand (12,457).
At the end of the period, unutilized credits with bank amounted to € 568 thousand (40) and with the principal owner Alceco International S.A € 4,544 thousand (4,544).
Equity at the end of the period amounted to € 32,067 thousand (27,218), the equity/assets ratio was 69 % (63 %) and the net debt/equity ratio was 33 % (45 %).
The parent company
The parent company´s net sales amounted to € 3 thousand (0), and net income before tax amounted to € -4,190 thousand (-3,852). The parent company's liquid assets at the end of the period amounted to € 1,232 thousand (228).
Future financing
Oasmia is currently in a product development phase and has as yet no cash flow that finances its business activities. The company is thus dependent on other financing alternatives. For this reason Oasmia continuously work with various financing activities to generate funding for its business. These activities include new credit lines, new equity, licence revenues and now also potential commercial revenues is anticipated. Available consolidated cash and cash equivalent as well as unutilized credit facilities are not sufficient to fund the operations during the next 12 months. However, in light of the presented alternatives and the recent developments in the company,
the Board of Directors asses that the prospects are good for the financing of the Company´s operations during next year.
Key ratios and other information
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
|---|---|---|---|---|---|
| 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* Weighted average number of shares (in thousands), before and after |
81,772 | 58,214 | 81,772 | 58,214 | 81,772 |
| dilution* | 81,772 | 58,214 | 81,772 | 58,214 | 68,605 |
| Earnings per share in €, before and after dilution* | -0.03 | -0.03 | -0.05 | -0.07 | -0.12 |
| Equity per share, €* | 0.39 | 0.47 | 0.39 | 0.47 | 0.44 |
| Equity/Assets ratio, % | 69 | 63 | 69 | 63 | 72 |
| Net debt, € thousand | 10,696 | 12,228 | 10,696 | 12,228 | 4,776 |
| Net debt/Equity ratio, % | 33 | 45 | 33 | 45 | 13 |
| 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 | 79 | 73 | 79 | 73 | 75 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
Definitions
Earnings per share: The income for the period attributable to the shareholders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity divided by the number of shares at the end of the period
Equity/assets ratio: Equity as a percentage of the balance sheet total.
Net debt: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deduction for liquid funds
Net debt/Equity ratio: Net debt in relation to equity.
Return on total assets: Income before deduction of interest expenses in relation to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
|---|---|---|---|---|---|
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 3 | - | 3 | - | - |
| Capitalized development cost | 816 | 1,976 | 1,591 | 3,088 | 5,525 |
| Other operating income | 6 | 7 | 494 | 11 | 287 |
| Raw materials, consumables and goods for resale | -137 | -231 | -260 | -438 | -697 |
| Other external expenses | -1,382 | -2,106 | -2,971 | -3,701 | -7,387 |
| Employee benefit expenses | -1,139 | -971 | -2,480 | -2,222 | -4,818 |
| Depreciation/amortization and impairment | -140 | -144 | -282 | -289 | -578 |
| Other operating expenses | - | - | - | - | -10 |
| Operating income | -1,974 | -1,469 | -3,903 | -3,552 | -7,678 |
| Financial income | 6 | 0 | 16 | 0 | 67 |
| Financial expenses | -152 | -185 | -303 | -299 | -612 |
| Financial items, net | -146 | -185 | -287 | -298 | -545 |
| Income before taxes | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Taxes | - | - | - | - | - |
| Income for the period | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Income for the period attributable to: | |||||
| Shareholders of the Parent company | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Earnings per share, before and after dilution, € | -0.03 | -0.03 | -0.05 | -0.07 | -0.12 |
Consolidated Statement of comprehensive income
| € thousands | 2013 Aug-Oct |
2012 Aug-Oct |
2013 May-Oct |
2012 May-Oct |
2012/13 May-April |
|---|---|---|---|---|---|
| Income for the period | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Comprehensive income for the period | -2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Comprehensive income for the period attributable to: Shareholders of the Parent company |
-2,120 | -1,655 | -4,190 | -3,850 | -8,223 |
| Comprehensive Earnings per share, before and after dilution, € | -0.03 | -0.03 | -0.05 | -0.07 | -0.12 |
Consolidated statement of financial position
| € thousands | 2013-10-31 | 2012-10-31 | 2013-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 2,754 | 3,200 | 2,972 |
| Capitalized development cost | 40,083 | 36,055 | 38,492 |
| Other intangible assets | 1,386 | 3,230 | 1,169 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 44,223 | 42,485 | 42,634 |
| Current assets | |||
| Inventories | 211 | 101 | 101 |
| Trade receivables | 3 | - | - |
| Other current receivables | 310 | 263 | 263 |
| Prepaid expenses and accrued income | 317 | 236 | 425 |
| Liquid assets | 1,233 | 229 | 7,152 |
| Total Current assets | 2,073 | 829 | 7,940 |
| TOTAL ASSETS | 46,297 | 43,313 | 50,574 |
| EQUITY | |||
| Capital and provisions attributable to shareholders of the Parent Company | |||
| Share capital | 929 | 650 | 929 |
| Other capital provided | 65,145 | 52,012 | 65,145 |
| Retained earnings | -34,007 | -25,444 | -29,817 |
| Total Equity | 32,067 | 27,218 | 36,257 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Long-term borrowing | - | 11,928 | - |
| Other non-current liabilities | 101 | 2,126 | 101 |
| Total Non-current liabilities | 101 | 14,055 | 101 |
| Current liabilities | |||
| Liabilities to credit institutions | - | 528 | - |
| Short-term borrowings | 11,928 | - | 11,928 |
| Trade payables | 460 | 794 | 805 |
| Other current liabilities | 192 | 171 | 178 |
| Accrued expenses and prepaid income | 1,548 | 547 | 1,305 |
| Total Current liabilities | 14,129 | 2,041 | 14,216 |
| Total Liabilities | 14,230 | 16,095 | 14,317 |
| TOTAL EQUITY AND LIABILITIES | 46,297 | 43,313 | 50,574 |
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | |||||
|---|---|---|---|---|---|
| Other capital | Retained | ||||
| € thousands | Share capital | provided | earnings | Total equity | |
| Opening balance as of May 1, 2012 | 650 | 52,012 | -21,594 | 31,068 | |
| Comprehensive income for the period | - | - | -3,850 | -3,850 | |
| Closing balance as of October 31, 2012 | 650 | 52,012 | -25,444 | 27,218 | |
| Opening balance as of May 1, 2012 | 650 | 52,012 | -21,594 | 31,068 | |
| Comprehensive income for the period | - | - | -8,223 | -8,223 | |
| New share issue | 279 | 13,656 | - | 13,935 | |
| Issue expenses | - | -522 | - | -522 | |
| Closing balance as of April 30, 2013 | 929 | 65,145 | -29,817 | 36,257 | |
| Opening balance as of May 1, 2013 | 929 | 65,145 | -29,817 | 36,257 | |
| Comprehensive income for the period | - | - | -4,190 | -4,190 | |
| Closing balance as of October 31, 2013 | 929 | 65,145 | -34,007 | 32,067 | |
| Consolidated Cash flow statement | |||||
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
| € thousands | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Operating activities | |||||
| Operating income before financial items | -1,974 | -1,469 | -3,903 | -3,552 | -7,678 |
| Depreciation/amortization | 140 | 144 | 282 | 289 | 578 |
| Disposals of tangible assets | - | - | - | - | 10 |
| Adjustments for income from divestiture of intangible assets | - | - | - | - | -179 |
| Interest received | 6 | 0 | 16 | 0 | 67 |
| Interest paid | -2 | -47 | -2 | -52 | -69 |
| Cash flow from operating activities before working capital changes | -1,830 | -1,372 | -3,608 | -3,314 | -7,272 |
| Change in working capital | |||||
| Change in inventories | -110 | - | -110 | -68 | -68 |
| Change in trade receivables | -3 | - | -3 | - | - |
| Change in other current receivables | -134 | -9 | 61 | -55 | -243 |
| Change in trade payables | 26 | 438 | -345 | -374 | -363 |
| Change in other current liabilities | -161 | -188 | -43 | -144 | 46 |
| Cash flow from operating activities | -2,212 | -1,131 | -4,048 | -3,954 | -7,900 |
| Investing activities | |||||
| Investments in intangible fixed assets | -962 | -2,104 | -1,864 | -4,292 | -6,771 |
| Divestiture of intangible fixed assets | - | - | - | - | 481 |
| Investments in property, plant and equipment | -4 | -286 | -7 | -486 | -503 |
| Cash flow from investing activities | -966 | -2,389 | -1,871 | -4,778 | -6,793 |
| Financing activities | |||||
| Increase in liabilities to credit institutions | - | 528 | - | 165 | - |
| Decrease in liabilities to credit institutions | - | - | - | - | -363 |
| New share issue | - | - | - | - | 13,935 |
| Issue expenses | - | - | - | - | -522 |
| New loans | - | 1,704 | - | 9,088 | 9,088 |
| Repayment of loans | - | - | - | -523 | -523 |
| Cash flow from financing activities | 0 | 2,232 | 0 | 8,731 | 21,615 |
| Cash flow for the period | -3,178 | -1,288 | -5,919 | -1 | 6,922 |
| Cash and cash equivalents at the beginning of the period | 4,411 | 1,517 | 7,152 | 230 | 230 |
| Cash and cash equivalents at the end of the period | 1,233 | 229 | 1,233 | 229 | 7,152 |
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - October 2013
THE PRE-CLINICAL AND CLINICAL PROGRAMS FOR THE DEVELOPMENT OF NEW PHARMACEUTICALS CONTINUE
SECOND QUARTER August 1 – October 31, 2013
- Consolidated Net sales amounted to TSEK 24 (0) 2
- Operating income amounted to TSEK 17 374 (-12 934)
- Net income after tax amounted to TSEK -18 661 (-14 564)
- Earnings per share amounted to SEK -0,23 (-0,25)
- Comprehensive income amounted to TSEK -18 661 (-14 564)
THE PERIOD May 1 – October 31, 2013
- Consolidated Net sales amounted to 24 (0)
- Operating income amounted to TSEK -34 359 (-31 263)
- Net income after tax amounted to TSEK -36 885 (-33 887)
- Earnings per share amounted to SEK -0,45 (-0,58)
- Comprehensive income amounted to TSEK -36 885 (-33 887)
- Oasmia initiated a clinical program for Paclical for treatment of breast cancer
- Oasmia initiated pre-clinical studies with OAS-19, the first pharmaceutical project with a combination of two active cytostatics in one infusion
EVENTS AFTER CLOSING DAY
- Increased funding through extension of MSEK 105 loan from Nexttobe and a new MSEK 40 bank loan
- Oasmia Announces Successful FDA Pre-Approval Inspection of Its Manufacturing Facility
CEO COMMENTS:
"During the second quarter we continued to work with both pre-clinical and clinical studies of our prioritized projects. Also, we have noted a continued interest for our patented technology platform XR-17 among other pharmaceutical companies looking for an excipient for their projects with insoluble pharmaceuticals", says CEO Julian Aleksov.
The numbers in brackets concern results from the corresponding period of the previous year
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
HUMAN HEALTH
Oasmia's research and development in human health is mainly focused on the common indications ovarian cancer and breast cancer.
Paclical®
Paclical® is a patented formulation of the commonly used cytostatic paclitaxel in combination with Oasmia's patented technology XR-17. Paclical® is designated as an orphan drug (see below) in EU and USA for the indication ovarian cancer.
Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer, an indication with 225,000 annual new cases globally. The total number of patients in the study is 789, and the final patient was treated in the beginning of 2013. All patients are now being followed up regarding time to progression. Oasmia is now closing the study in order to evaluate the results. The results will be used for submission of marketing authorization applications for Paclical® in the EU, the US and RoW for the treatment of ovarian cancer.
Oasmia initiated in the summer of 2013 a clinical dose-finding study with Paclical for weekly treatment of breast cancer.
In September 2012, Oasmia submitted an application for market authorization for Paclical® in Russia, which is currently being processed by the Russian pharmaceutical authority.
Doxophos®
Doxophos® is a patented formulation of doxorubicin in combination with XR-17. Doxorubicin is one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation for this product candidate and is now planning the clinical program.
Docecal®
Docecal® is a patented formulation of the cytostatic docetaxel in combination with XR-17. Oasmia has initiated the validation process for manufacture of Docecal®, and is preparing a clinical program for the product candidate.
OAS-19
OAS-19 is the first oncology product candidate to apply a dual cytostatic agent encapsulation and release mechanism in one infusion. It is the unique properties in XR-17 that make this combination possible. This concept provides Oasmia with one more dimension for pharmaceutical development of multiple active substances in one micelle where also substances with different solubility can be combined. Recent pre-clinical studies have shown promising results, and the company plans to start clinical studies with OAS-19 in 2014.
Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (USA) years on the indication, when the drug is approved for market.
ANIMAL HEALTH
Product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs. The company is focusing on two common indications, mastocytoma and lymphoma, which comprise about half of all cancers in dogs. Product development has made it possible to expand the range of indications to include also mammary carcinoma and squamous cell carcinoma.
Paccal® Vet
Paccal® Vet is a patented formulation of paclitaxel, in combination with XR-17.
Oasmia has submitted an application to the American Food and Drug Administration (FDA) for market authorization of Paccal® Vet for treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma. Oasmia is expecting response from the FDA.
All indications, for which an application has been submitted to the FDA, have previously been granted MUMS designation (see below) by the FDA.
Oasmia has an ongoing study with Paccal Vet for treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs who has been treated 4 times with three week intervals. When data have been collected and analysed, Oasmia intends to file an application for market approval for Paccal® Vet to the European authority EMA.
Doxophos® Vet
Doxophos® Vet is a patented formulation of doxorubicin in combination with XR-17. Oasmia is developing Doxophos® Vet for treatment of lymphoma (lymph node cancer), which is one of the most common cancer indications in dogs. Doxophos® Vet has been granted a MUMS designation (see below) in the USA for the indication lymphoma.
Oasmia conducts a Phase I study for Doxophos® Vet in order to establish the dose for the clinical program.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE1 | PHASE II | PHASE III | REG. APPROVAL |
|---|---|---|---|---|---|---|
| Paccal ® Vet (paclitaxel) |
Mastocytoma /mammary/ squamous cell |
In Registration | ||||
| Doxophos® Vet (doxorubicin) |
Lymphoma | Ongoing |
BOLAGET MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
Annual General Meeting 2013
At the Annual General Meeting in September 2013, the Board of Directors was re-elected and Alexander Kotsinas was elected as a new Member of the Board. Alexander Kotsinas is a member of the management of the investment company Nexttobe, the second largest shareholder in Oasmia.
Warrants
At the Annual General Meeting in September it was decided that the Board of Directors and management should have the right to purchase warrants in Oasmia Pharmaceutical AB. In October, the maximum number of warrants 1 050 000, was issued from the parent company to the subsidiary Oasmia Animal Health AB. The subsidiary has the right and the obligation to sell the warrants to the Board of Directors and to management. For further details about conditions, see communiqué from the AGM on Oasmia´s website. As per October 31, no purchases of warrants had been executed.
Share price development during 2013 (SEK)
EVENTS AFTER CLOSING DAY
Increased funding through extension of MSEK 105 loan from Nexttobe and a new MSEK 40 bank loan The existing loan from Nexttobe was extended by one year, from December 31, 2013 to December 31, 2014. The current interest of 5 % will be 8.5 % in 2014. The interest will be paid in full on December 31, 2014. Furthermore, Oasmia was granted a new MSEK 40 bank loan with a term from December 1, 2013 to March 31, 2014.
Oasmia successfully passed an FDA Pre-Approval Inspection of Its Manufacturing Facility The Swedish pharmaceutical company Oasmia Pharmaceutical AB (publ), listed on Nasdaq OMX in Stockholm and the Frankfurt Stock Exchange, announced on December 3, that its manufacturing facility in Uppsala, Sweden, has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA). With this inspection, the FDA confirmed that Oasmia's manufacturing facility with respect to Paccal® Vet (paclitaxel) meets the requirements of Current Good Manufacturing Practice (cGMP).
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
|---|---|---|---|---|---|
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 24 | - | 24 | - | - |
| Capitalized development cost | 7 181 | 17 395 | 14 006 | 27 184 | 48 635 |
| Operating income | -17 374 | -12 934 | -34 359 | -31 263 | -67 583 |
| Net income after tax | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 |
| Earnings per share (SEK), before and after dilution* | -0,23 | -0,25 | -0,45 | -0,58 | -1,06 |
| Comprehensive income for the period | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
SECOND QUARTER August 1 – October 31, 2013
Net sales Net sales amounted to TSEK 24 (-).
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to TSEK 7 818 (17 395). The larger part concerned Paclical which was capitalized with TSEK 4 103 (17 169) and a smaller part concerning Paccal Vet which contributed with TSEK 3 078 (226). The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials for Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment were significantly lower compared to the previous year and amounted to TSEK 23 400 (29 124). The decrease was due to that the clinical trial with Paclical for treatment of ovarian cancer was near completion.
Income for the quarter Net income was TSEK -18 661 (-14 564). The decrease was attributable to lower capitalization of development costs compared to the corresponding quarter the previous year.
THE PERIOD May 1 – October 31, 2013
Net sales
Net sales amounted to TSEK 24 (-)
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to TSEK 14 006 (27 184). The larger part concerned Paclical which was capitalized with TSEK 8 661 (26 958) and a smaller part concerning Paccal Vet which contributed with TSEK 5 344 (226). The decrease compared to the same period in the previous year is attributable to decreased costs for clinical trials for Paclical®.
Other operating income
Other operating income amounted to TSEK 4 353 (96) and mainly concerned an insurance compensation for a production disruption amounting to TSEK 4 250.
Operating expenses
Operating expenses excluding depreciation and impairment were significantly lower compared to the previous year and amounted to TSEK 50 262 (55 996). The decrease was due to that the clinical trial with Paclical for treatment of ovarian cancer was near completion.
The number of employees at the end of the period was 79 (73).
Income for the period
Net income was TSEK -36 885 (-33 887). The decrease was attributable to lower capitalization of development costs compared to the corresponding period the previous year.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Cash flow and Capital expenditures
Cash flow from operating activities amounted to TSEK -35 635 (-34 804).
Cash flow from investing activities amounted to TSEK -16 471 (-42 061). The decreased level of investments concerned capitalized development costs and other intangible assets and property, plant and equipment.
Of these, investments in intangible assets amounted to TSEK 16 408 (37 780), consisting of capitalized development costs TSEK 14 006 (27 184) and patents and other intangible assets TSEK 2 402 (10 597).
Of these, only TSEK 62 (4 281) were investments in property, plant and equipment.
Financing
Financing in the period was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012. The liquid assets were strengthened by an insurance compensation.
Financial position
The consolidated liquid assets at the end of the period amounted to TSEK 10 851 (2 017). The interest-bearing liabilities were TSEK 105 000 (109 651).
At the end of the period, unutilized credits with bank amounted to TSEK 5 000 (349) and with the principal owner Alceco International S.A TSEK 40 000 (40 000).
Equity at the end of the period amounted to TSEK 282 268 (239 586), the equity/assets ratio was 69 % (63 %) and the net debt/equity ratio was 33 % (45 %).
The parent company
The parent company´s net sales amounted to TSEK 24 (0) and net income before tax amounted to TSEK -36 887 (-33 906). The parent company's liquid assets at the end of the period amounted to TSEK 10 842 (2 009).
Future financing
Oasmia is currently in a product development phase and has as yet no cash flow that finances its business activities. The company is thus dependent on other financing alternatives. For this reason Oasmia continuously work with various financing activities to generate funding for its business. These activities include new credit lines, new equity, license revenues and now also potential commercial revenues is anticipated. Available consolidated cash and cash equivalent as well as unutilized credit facilities are not sufficient to fund the operations during the
next 12 months. However, in light of the presented alternatives and the recent developments in the company , the Board of Directors asses that the prospects are good for the financing of the Company´s operations during next year.
Key ratios and other information
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
|---|---|---|---|---|---|
| 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 * | 81 772 | 58 214 | 81 772 | 58 214 | 81 772 |
| Weighted average number of shares (in thousands) before and after | |||||
| dilution* | 81 772 | 58 214 | 81 772 | 58 214 | 68 605 |
| Earnings per share in SEK, before and after dilution* | -0,23 | -0,25 | -0,45 | -0,58 | -1,06 |
| Equity per share, SEK* | 3,45 | 4,12 | 3,45 | 4,12 | 3,90 |
| Equity/Assets ratio, % | 69 | 63 | 69 | 63 | 72 |
| Net debt, TSEK | 94 149 | 107 634 | 94 149 | 107 634 | 42 044 |
| Net debt/Equity ratio, % | 33 | 45 | 33 | 45 | 13 |
| 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 | 79 | 73 | 79 | 73 | 75 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
Definitions
Earnings per share: The income for the period attributable to the shareholders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity divided by the number of shares at the end of the period
Equity/assets ratio: Equity as a percentage of the balance sheet total.
Net debt: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deduction for liquid funds
Net debt/Equity ratio: Net debt in relation to equity.
Return on total assets: Income before deduction of interest expenses in relation to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2013 | 2012 | 2013 | 2012 | 2012/13 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 24 | - | 24 | - | - | |
| Capitalized development cost | 7 181 | 17 395 | 14 006 | 27 184 | 48 635 | |
| Other operating income | 53 | 65 | 4 353 | 96 | 2 524 | |
| Raw materials, consumables and goods for resale | -1 203 | -2 035 | -2 286 | -3 858 | -6 137 | |
| Other external expenses | -12 166 | -18 542 | -26 148 | -32 577 | -65 022 | |
| Employee benefit expenses | -10 030 | -8 546 | -21 827 | -19 560 | -42 408 | |
| Depreciation/amortization and impairment | -1 233 | -1 270 | -2 479 | -2 547 | -5 089 | |
| Other operating expenses | - | - | - | - | -86 | |
| Operating income | -17 374 | -12 934 | -34 359 | -31 263 | -67 583 | |
| Financial income | 55 | 1 | 140 | 4 | 587 | |
| Financial expenses | -1 342 | -1 631 | -2 666 | -2 628 | -5 384 | |
| Financial items, net | -1 287 | -1 630 | -2 526 | -2 625 | -4 798 | |
| Income before taxes | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 | |
| Taxes | 2 | - | - | - | - | - |
| Income for the period | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 | |
| Income for the period attributable to: | ||||||
| Shareholders of the Parent company | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 | |
| Earnings per share before and after dilution, SEK | -0,23 | -0,25 | -0,45 | -0,58 | -1,06 |
Consolidated Statement of Comprehensive income
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
|---|---|---|---|---|---|
| TSEK | Note Aug-Oct |
Aug-Oct | May-Oct | May-Oct | May-April |
| Income for the period | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 |
| Comprehensive income for the period | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 |
| Comprehensive income for the period attributable to: |
|||||
| Shareholders of the Parent company | -18 661 | -14 564 | -36 885 | -33 887 | -72 381 |
| Comprehensive Earnings per share before and after dilution, SEK |
-0,23 | -0,25 | -0,45 | -0,58 | -1,06 |
Consolidated statement of financial position
| TSEK | Note | 2013-10-31 | 2012-10-31 | 2013-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 24 243 | 28 165 | 26 161 | |
| Capitalized development cost | 3 | 352 832 | 317 375 | 338 826 |
| Other intangible assets | 12 198 | 28 431 | 10 294 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 389 274 | 373 972 | 375 283 | |
| Current assets | ||||
| Inventories | 1 853 | 887 | 887 | |
| Trade receivables | 30 | - | - | |
| Other current receivables | 2 726 | 2 311 | 2 314 | |
| Prepaid expenses and accrued income | 2 792 | 2 080 | 3 737 | |
| Liquid assets | 10 851 | 2 017 | 62 956 | |
| Total Current assets | 18 252 | 7 295 | 69 895 | |
| TOTAL ASSETS | 407 526 | 381 267 | 445 178 | |
| EQUITY | ||||
| Capital and provisions attributable to shareholders of the Parent Company | ||||
| Share capital | 8 177 | 5 724 | 8 177 | |
| Other capital provided | 573 439 | 457 832 | 573 439 | |
| Retained earnings | -299 348 | -223 969 | -262 463 | |
| Total equity | 282 268 | 239 586 | 319 153 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Long-term borrowing | - | 105 000 | - | |
| Other non-current liabilities | 891 | 18 716 | 891 | |
| Total Non-current liabilities | 891 | 123 716 | 891 | |
| Current liabilities | ||||
| Liabilities to credit institutions | - | 4 651 | - | |
| Short-term borrowings | 4 | 105 000 | - | 105 000 |
| Trade payables | 4 052 | 6 991 | 7 084 | |
| Other current liabilities | 1 692 | 1 506 | 1 566 | |
| Accrued expenses and prepaid income | 13 624 | 4 817 | 11 484 | |
| Total Current liabilities | 124 367 | 17 964 | 125 134 | |
| Total Liabilities | 125 258 | 141 680 | 126 025 | |
| TOTAL EQUITY AND LIABILITIES | 407 526 | 381 267 | 445 178 | |
| Contingent liabilities | 5 |
Pledged assets 5
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | |||||
|---|---|---|---|---|---|
| Other | |||||
| capital provid | Retained earn | ||||
| TSEK | Share capital | ed | ings | Total equity | |
| Opening balance as of May 1, 2012 | 5 724 | 457 832 | -190 082 | 273 474 | |
| Comprehensive income for the period | - | - | -33 887 | -33 887 | |
| Closing balance as of October 31, 2012 | 5 724 | 457 832 | -223 969 | 239 586 | |
| Opening balance as of May 1, 2012 | 5 724 | 457 832 | -190 082 | 273 474 | |
| Comprehensive income for the period | - | - | -72 381 | -72 381 | |
| New share issue | 2 453 | 120 205 | - | 122 658 | |
| Issue expenses | - | -4 598 | - | -4 598 | |
| Closing balance as of April 30, 2013 | 8 177 | 573 439 | -262 463 | 319 153 | |
| Opening balance as of May 1, 2013 | 8 177 | 573 439 | -262 463 | 319 153 | |
| Comprehensive income for the period | - | - | -36 885 | -36 885 | |
| Closing balance as of October 31, 2013 | 8 177 | 573 439 | -299 348 | 282 268 | |
| Consolidated Cash flow statement | |||||
| 2013 | 2012 | 2013 | 2012 | 2012/13 | |
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Operating activities | |||||
| Operating income before financial items | -17 374 | -12 934 | -34 359 | -31 263 | -67 583 |
| Depreciation/amortization | 1 233 | 1 270 | 2 479 | 2 547 | 5 089 |
| Disposals of tangible assets | - | - | - | - | 86 |
| Adjustments for income from divestiture of intangible assets | - | - | - | - | -1 579 |
| Interest received | 55 | 1 | 140 | 4 | 587 |
| Interest paid | -19 | -412 | -20 | -456 | -611 |
| Cash flow from operating activities before working | |||||
| capital changes | -16 105 | -12 075 | -31 759 | -29 167 | -64 010 |
| Change in working capital | |||||
| Change in inventories | -966 | - | -966 | -597 | -597 |
| Change in trade receivables | -30 | - | -30 | - | - |
| Change in other current receivables | -1 182 | -77 | 533 | -482 | -2 142 |
| Change in trade payables | 228 | 3 853 | -3 033 | -3 291 | -3 197 |
| Change in other current liabilities | -1 419 | -1 658 | -380 | -1 266 | 408 |
| Cash flow from operating activities | -19 474 | -9 957 | -35 635 | -34 804 | -69 539 |
| Investing activities | |||||
| Investments in intangible fixed assets | -8 470 | -18 517 | -16 408 | -37 780 | -59 603 |
| Divestiture of intangible fixed assets | - | - | - | - | 4 235 |
| Investments in property, plant and equipment | -34 | -2 516 | -62 | -4 281 | -4 428 |
| Cash flow from investing activities | -8 504 | -21 034 | -16 471 | -42 061 | -59 795 |
| Financing activities | |||||
| Increase in liabilities to credit institutions | - | 4 651 | - | 1 454 | - |
| Decrease in liabilities to credit institutions | - | - | - | - | -3 197 |
| New share issue | - | - | - | - | 122 658 |
| Issue expenses | - | - | - | - | -4 598 |
| New loans 4 |
- | 15 000 | - | 80 000 | 80 000 |
| Repayment of loans | - | - | - | -4 600 | -4 600 |
| Cash flow from financing activities | 0 | 19 651 | 0 | 76 854 | 190 263 |
| Cash flow for the period | -27 978 | -11 339 | -52 106 | -11 | 60 928 |
| Cash and cash equivalents at the beginning of the | |||||
| period | 38 829 | 13 356 | 62 956 | 2 028 | 2 028 |
| Cash and cash equivalents at the end of the period | 10 851 | 2 017 | 10 851 | 2 017 | 62 956 |
Parent Company Income statement
| 2013 | 2012 | 2013 | 2012 | 2012/13 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 24 | - | 24 | - | - | |
| Capitalized development cost | 7 181 | 17 395 | 14 006 | 27 184 | 48 635 | |
| Other operating income | 53 | 65 | 4 353 | 96 | 2 524 | |
| Raw materials, consumables and goods for resale | -1 203 | -2 035 | -2 286 | -3 858 | -6 137 | |
| Other external expenses | -12 156 | -18 513 | -26 123 | -32 519 | -64 916 | |
| Employee benefit expenses | -10 030 | -8 546 | -21 827 | -19 560 | -42 408 | |
| Depreciation/amortization and impairment of prop erty, plant, equipment and intangible assets |
-1 231 | -1 266 | -2 476 | -2 540 | -5 074 | |
| Other operating expenses | - | - | - | - | -86 | |
| Operating income | -17 362 | -12 901 | -34 330 | -31 197 | -67 461 | |
| Result from participations in Group companies | 4 | -30 | -30 | -30 | -85 | -145 |
| Other interest revenues and similar revenues | 55 | 1 | 140 | 3 | 587 | |
| Interest cost and similar costs | -1 342 | -1 631 | -2 666 | -2 628 | -5 384 | |
| Financial items, net | -1 317 | -1 660 | -2 556 | -2 709 | -4 942 | |
| Income after financial items | -18 679 | -14 561 | -36 887 | -33 906 | -72 404 | |
| Taxes | 2 | - | - | - | - | - |
| Income for the period | -18 679 | -14 561 | -36 887 | -33 906 | -72 404 |
Parent Company Balance Sheet
| TSEK | Note | 2013-10-31 | 2012-10-31 | 2013-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 352 832 | 317 375 | 338 826 |
| similar rights Property, plant and equipment |
12 194 | 28 417 | 10 288 | |
| Equipment, tools, fixtures and fittings Construction in progress and advance payments |
18 417 | 22 082 | 20 355 | |
| for property, plant and equipment Financial assets |
5 826 | 6 082 | 5 805 | |
| Participations in group companies | 110 | 110 | 110 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 389 380 | 374 067 | 375 386 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 1 656 | 887 | 887 | |
| Advance payments to suppliers | 197 | - | - | |
| 1 853 | 887 | 887 | ||
| Current receivables | ||||
| Trade receivables | 30 | - | - | |
| Other current receivables | 2 724 | 2 309 | 2 312 | |
| Prepaid expenses and accrued income | 2 785 | 2 061 | 3 721 | |
| 5 540 | 4 370 | 6 033 | ||
| Cash and bank balances | 10 842 | 2 009 | 62 947 | |
| Total current assets | 18 235 | 7 267 | 69 867 | |
| TOTAL ASSETS | 407 615 | 381 334 | 445 253 | |
| EQUITY AND LIABILITIES Equity Restricted equity |
||||
| Share capital | 8 177 | 5 724 | 8 177 | |
| Statutory reserve | 4 620 | 4 620 | 4 620 | |
| 12 797 | 10 344 | 12 797 | ||
| Non-restricted equity | ||||
| Share premium reserve | 573 439 | 457 832 | 573 439 | |
| Retained earnings | -267 255 | -194 851 | -194 851 | |
| Income for the period | -36 887 | -33 906 | -72 404 | |
| 269 297 | 229 075 | 306 184 | ||
| Total equity | 282 095 | 239 419 | 318 981 | |
| Non-current liabilities | ||||
| Long term borrowings | - | 105 000 | - | |
| Other non-current liabilities | 891 | 18 716 | 891 | |
| Total non-current liabilities | 891 | 123 716 | 891 | |
| Current liabilities | ||||
| Short term borrowings | 4 | 105 000 | - | 105 000 |
| Trade payables | 4 052 | 6 991 | 7 084 | |
| Liabilities to Credit institutions | - | 4 651 | - | |
| Liabilities to group companies | 262 | 235 | 247 | |
| Other current liabilities | 1 692 | 1 506 | 1 566 | |
| Accrued expenses and prepaid income | 13 624 | 4 817 | 11 484 | |
| Total Current liabilities | 124 630 | 18 199 | 125 381 | |
| TOTAL EQUITY AND LIABILITIES | 407 615 | 381 334 | 445 253 | |
| Contingent liabilities and pledged assets | ||||
| Contingent liabilities | 5 | - | - | - |
| Pledged assets | 5 | 8 000 | 8 000 | 8 000 |
Parent Company changes in equity
| Restricted equity | |||||
|---|---|---|---|---|---|
| TSEK | Share capital | Statutory reserve |
Non-restricted equity |
Total equity | |
| Opening balance as of May 1, 2012 | 5 724 | 4 620 | 262 981 | 273 325 | |
| Income for the period | - | - | -33 906 | -33 906 | |
| Closing balance as of October 31, 2012 | 5 724 | 4 620 | 229 075 | 239 419 | |
| Opening balance as of May 1, 2012 | 5 724 | 4 620 | 262 981 | 273 325 | |
| New share issue | 2 453 | - | 120 205 | 122 658 | |
| Issue expenses | - | - | -4 598 | -4 598 | |
| Income for the period | - | - | -72 404 | -72 404 | |
| Closing balance as of April 30, 2013 | 8 177 | 4 620 | 306 184 | 318 981 | |
| Opening balance as of May 1, 2013 | 8 177 | 4 620 | 306 184 | 318 981 | |
| Income for the period | - | - | -36 887 | -36 887 | |
| Closing balance as of October 31, 2013 | 8 177 | 4 620 | 269 297 | 282 095 |
Note 1 Accounting policies
This 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 2012 – April 30 2013. The new and revised accounting policies applied by Oasmia since May 1, 2013, has not had any effect on Oasmia's financial reports. New or revised IFRS-standards or interpretations of IFRIC which have been adopted since May 1, 2013, have, beyond additional information regarding financial instruments as a result of the new IFRS 13, not had any effect on Oasmia's financial reports. Scope and character of financial assets and liabilities are in essence the same as of April 30, 2013. Similar to what was the case at the end of the previous fiscal year, carried amounts are the same as actual values. 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 336 605 (262 155) and the Parent Company has similar amounting to TSEK 327 019 (252 653). 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
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. The accumulated assets per product candidate are disclosed below.
| TSEK | 2013-10-31 | 2012-10-31 | 2013-04-30 |
|---|---|---|---|
| Paclical® | 263 137 | 236 098 | 254 475 |
| Paccal® Vet | 89 695 | 81 277 | 84 351 |
| Total | 352 832 | 317 375 | 338 826 |
Note 4 Transactions with related parties
No significant transactions with related parties have been performed in the period.
As of October 31, 2013 Oasmia had a credit facility of TSEK 40 000 (40 000) provided by the principal owner of the company, Alceco International SA. The interest rate on utilized credits is 5 %. As of October 31, 2013, this credit was completely unutilized (also as of October 31, 2012).
On October 31, 2013, Oasmia carried a loan from its second largest owner Nexttobe AB amounting to TSEK 105,000 (105 000). As of October 31, 2013, the accrued interest cost for the borrowing was TSEK 7 699 (2 452). Until December 31, the interest rate is 5 % and will be paid when the loan is due. In November 2013, the loan was extended with one year and is now due on December 31, 2014, see Events after closing day.
Oasmia has made a TSEK 30 (85) group contribution to the subsidiary Qdoxx Pharma AB, where TSEK 30 (30) was provided in the second quarter. Impairment of shares in Qdoxx amounting to TSEK 30 (85) have been made, corresponding to the group contributions, as the purpose of the group contributions was to cover losses in the subsidiary. The impairment of Participations in group companies is accounted for in the Parent company income statement on the line Result from participations 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 2012 – April 30 2013. No additional risks beyond those described therein have been judged significant.
The Board of Directors and CEO of Oasmia Pharmaceutical AB ensures that this Interim report gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group face.
| Uppsala, December 5, 2013 | ||
|---|---|---|
| Joel Citron, Chairman | ||
| Bo Cederstrand, Member | Prof. Dr. Horst Domdey, Member | Alexander Kotsinas, Member |
| Jan Lundberg, Member | Martin Nicklasson, Member | Julian Aleksov, Member and CEO |
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 5, 2013 at 9.00.
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, 2013 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, 2013, 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.
Emphasis of Matter
Without qualifying our opinion, we draw attention to the information in the interim financial statements which describes that the company is dependend on revenue, capital contribution or other financing to be able to continue as going concern. If the company not obtains financing as the board of directors expect there is a risk for the companys abiltity to continue as going concern .
Uppsala December 5, 2013
Ernst & Young AB
Björn Ohlsson Authorized Public Accountant
COMPANY INFORMATION Oasmia Pharmaceutical AB (publ) Corp. Reg. No: 556332 -667601 Domicile: Stockholm
Address and telephone number to the Main Office Vallongatan 1 752 28 UPPSALA, SWEDEN +46 18 50 54 40 www.oasmia.com [email protected]
Questions concerning the report are answered by: Mikael Widell, Vice President Communications Phone +46 70 311 99 60 E-mail: Mika[email protected]om
UPCOMING REPORT DATES
| Interim report May 2013 – January 2014 | 2014-03-06 |
|---|---|
| Year-end report May 2013 – April 2014 | 2014-06-05 |
| Annual report May 2013 – April 2014 | 2014-08-21 |
| Interim report May – July 2014 | 2014-09-05 |
| Interim report May – October 2014 | 2014-12-04 |