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Vivesto — Interim / Quarterly Report 2013
Sep 6, 2013
3124_10-q_2013-09-06_e91d7641-0b1f-46a7-a1d5-ef4bb0a564e0.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2013 €
Page 1-8 is a service to shareholders in the euro zone. It is not the official report in the functional currency of Oasmia, which is SEK, but the first eight pages of that report converted to EUR. The full official report will be found on pages 9-20. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per July 31, 2013 which was 8.7106 SEK per one EUR. When occasional figures are in SEK or USD it is because the amount is very firmly denominated in that currency.
MORE PROJECTS INITIATED WITH THE XR-17 TECHNOLOGY
FIRST QUARTER May 1 – July 31, 2013
- Consolidated Net sales amounted to € 0 thousand (0)1
- Operating income amounted to € -1,950 thousand (-2,104)
- Net income after tax amounted to € -2,092 thousand (-2,218)
- Earnings per share amounted to € -0.03 (-0.04)
- Comprehensive income amounted to € -2,092 thousand (-2,218)
- Oasmia initiated pre-clinical studies with OAS-19 which is the first pharmaceutical project containing two active cytostatics in one infusion based on the company's unique technology XR-17
- Oasmia started a clinical program with Paclical® for treatment of breast cancer
- The SEDA agreement with YA Global Master SPV Ltd expired on July 21, 2013 and was not extended
CEO COMMENTS:
"The patented technology XR-17 is the heart of our R&D and during the period, we were able to continue the clinical program with Paclical®, as well as initiate development of OAS-19, which is a new and unique product candidate for combination therapies with two cytostatics in one infusion, for treatment of the most common cancer indications. We also saw a growing interest for our technology among prominent pharmaceutical companies", says Julian Aleksov, CEO of Oasmia.
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 cancer indications ovarian, breast and prostate.
Paclical®
Paclical® is a patented formulation of the commonly used substance 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 790, and the final patient was treated in the beginning of 2013. All patients are now being followed up regarding time to progression. When these data has been evaluated, Oasmia aims to submit marketing authorization applications for Paclical®, for the treatment of ovarian cancer, in the EU, the US and ROW.
In September 2012, Oasmia submitted an application for market authorization for Paclical® in Russia, which is currently being processed by the pharmaceutical authorities in the country.
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 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. Oasmia's unique micellar drug delivery system XR-17 allows the combination of agents with unequal solubility properties or low solubility. This concept provides Oasmia with a new platform for further pharmaceutical development of multiple active substances in one micelle. Recent preclinical studies have shown promising results, and the company plans to start clinical studies with OAS-19 in 2014.
| HUIIIIII HEAIUI | ||||||
|---|---|---|---|---|---|---|
| PRODUCT CANDIDATE |
INDICATION | PRE-CLINICAL | PHASE I | PHASE II | PHASE III | REGISTRATION |
| Paclical ® | Ovarian cancer | |||||
| Doxophos® | Breast cancer | |||||
| Docecal ® | Breast/prostate cancer |
|||||
| OAS-19 | Various cancers |
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 the two most 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 a response from the FDA.
All three 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 comprising 50 dogs. One parameter in the study is time to progression. When such data have been collected and analyzed, 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 the most common cancer indication in dogs. Doxophos® Vet has been granted a MUMS designation (see below) in the USA for the indication lymphoma.
Oasmia is currently finalizing a Phase I study for Doxophos® Vet which will comprise around 15 dogs.
| Animal Health | ||||||
|---|---|---|---|---|---|---|
| PRODUCT CANDIDATE |
INDICATION | PRE-CLINICAL | PHASE I | PHASE II | PHASE III | REGISTRATION |
| Paccal ® Vet | Mastocytoma | |||||
| Doxophos® Vet | Lymphoma |
THE COMPANY 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
The SEDA agreement was not extended
Oasmia has had a SEDA agreement (standby equity distribution agreement) with YA Global Master SPV Ltd which expired on July 21, 2013. The agreement was never utilized and no extension was made.
Share price development during 2013 (SEK)
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013 | 2012 | 2012/13 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Net sales | - | - | - |
| Capitalized development cost | 783 | 1,124 | 5,583 |
| Operating income | -1,950 | -2,104 | -7,759 |
| Net income after tax | -2,092 | -2,218 | -8,310 |
| Earnings per share (€), before and after dilution* | -0.03 | -0.04 | -0.12 |
| Comprehensive income for the period | -2,092 | -2,218 | -8,310 |
*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.
FIRST QUARTER
May 1 – July 31, 2013
Net sales
Oasmia had no net sales in the quarter (-).
Capitalized development cost
Capitalized development cost amounted to € 783 thousand (1,124) and concerned mainly Paclical®. Paccal® Vet was also included with € 260 thousand (-). The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials in Phase III for Paclical®.
Other operating income
Other operating income amounted to € 494 thousand (4) and consisted mainly of an insurance compensation amounting to € 488 thousand.
Operating expenses
Operating expenses excluding depreciation and impairment were by and large unchanged compared to the previous year and amounted to € 3,084 thousand (3,085).
The number of employees at the end of the quarter was 76, which was unchanged compared to same period in the previous year.
Income for the quarter
Net income was € -2,092 thousand (-2,218). The increase is attributable to an insurance compensation.
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 € -1,855 thousand (-2,852). The improvement consisted of an insurance compensation and a lowered level of payments to suppliers compared to the previous year.
Cash flow from investing activities amounted to € -915 thousand (-2,414). 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 € 911 thousand (2,211), consisting of capitalized development costs € 783 thousand (1,124) and patents and other intangible assets € 128 thousand (1,088).
Of these, only € 3 thousand (203) were investments in property, plant and equipment.
Financing
Financing in the quarter 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 quarter amounted to € 4,458 thousand (1,533). The interestbearing liabilities were € 12,054 thousand (10,332).
At the end of the quarter, unutilized credits with bank and the principal owner Alceco International S.A. amounted to € 574 thousand (574) and € 4,592 thousand (2,870) respectively.
Equity at the end of the quarter amounted to € 34,547 thousand (29,177), the equity/assets ratio was 71 % (68 %) and the net debt/equity ratio was 22 % (30 %).
The parent company
The parent company´s net sales amounted to € 0 (0) and net income before tax amounted to € -2,090 thousand (-2,221). The parent company's liquid assets at the end of the quarter amounted to € 4,457 thousand (1,532).
Key ratios and other information
| 2013 | 2012 | 2012/13 | |
|---|---|---|---|
| May-July | May-July | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* | 81,772 | 58,214 | 81,772 |
| Weighted average number of shares (in thousands) before and after dilution* | 81,772 | 58,214 | 68,605 |
| Earnings per share in €, before and after dilution* | -0.03 | -0.04 | -0.12 |
| Equity per share, €* | 0.42 | 0.50 | 0.45 |
| Equity/Assets ratio, % | 71 | 68 | 72 |
| Net debt, € thousand | 7,597 | 8,799 | 4,827 |
| Net debt/Equity ratio, % | 22 | 30 | 13 |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 76 | 76 | 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 | 2012/13 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Net sales | - | - | - |
| Capitalized development cost | 783 | 1,124 | 5,583 |
| Other operating income | 494 | 4 | 290 |
| Raw materials, consumables and goods for resale | -124 | -209 | -705 |
| Other external expenses | -1,605 | -1,611 | -7,465 |
| Employee benefit expenses | -1,354 | -1,264 | -4,869 |
| Depreciation/amortization and impairment | -143 | -147 | -584 |
| Other operating expenses | - | - | -10 |
| Operating income | -1,950 | -2,104 | -7,759 |
| Financial income | 10 | 0 | 67 |
| Financial expenses | -152 | -114 | -618 |
| Financial items, net | -142 | -114 | -551 |
| Income before taxes | -2,092 | -2,218 | -8,310 |
| Taxes | - | - | - |
| Income for the period | -2,092 | -2,218 | -8,310 |
| Income for the period attributable to: | |||
| Shareholders of the Parent company | -2,092 | -2,218 | -8,310 |
| Earnings per share, before and after dilution, € | -0.03 | -0.04 | -0.12 |
Consolidated Statement of comprehensive income
| 2013 | 2012 | 2012/13 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Income for the period | -2,092 | -2,218 | -8,310 |
| Comprehensive income for the period | -2,092 | -2,218 | -8,310 |
| Comprehensive income for the period attributable to: | |||
| Shareholders of the Parent company | -2,092 | -2,218 | -8,310 |
| Comprehensive Earnings per share, before and after dilution, € | -0.03 | -0.04 | -0.12 |
Consolidated statement of financial position
| € thousands | 2013-07-31 | 2012-07-31 | 2013-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 2,891 | 3,064 | 3,003 |
| Capitalized development cost | 39,682 | 34,439 | 38,898 |
| Other intangible assets | 1,282 | 3,161 | 1,182 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 43,855 | 40,664 | 43,084 |
| Current assets | |||
| Inventories | 102 | 102 | 102 |
| Other current receivables | 223 | 191 | 266 |
| Prepaid expenses and accrued income | 274 | 304 | 429 |
| Liquid assets | 4,458 | 1,533 | 7,228 |
| Total Current assets | 5,057 | 2,130 | 8,024 |
| TOTAL ASSETS | 48,912 | 42,794 | 51,108 |
| EQUITY | |||
| Capital and provisions attributable to shareholders of the Parent Company | |||
| Share capital | 939 | 657 | 939 |
| Other capital provided | 65,832 | 52,560 | 65,832 |
| Retained earnings | -32,224 | -24,040 | -30,131 |
| Total Equity | 34,547 | 29,177 | 36,640 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 102 | 1,867 | 102 |
| Total Non-current liabilities | 102 | 1,867 | 102 |
| Current liabilities | |||
| Short-term borrowings | 12,054 | 10,332 | 12,054 |
| Trade payables | 439 | 360 | 813 |
| Other current liabilities | 185 | 179 | 180 |
| Accrued expenses and prepaid income | 1,584 | 879 | 1,318 |
| Total Current liabilities | 14,262 | 11,750 | 14,366 |
| Total Liabilities | 14,365 | 13,617 | 14,468 |
| TOTAL EQUITY AND LIABILITIES | 48,912 | 42,794 | 51,108 |
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | |||||
|---|---|---|---|---|---|
| Other | |||||
| € thousands | Share capital | capital provided | Retained earnings | Total equity | |
| Opening balance as of May 1, 2012 | 657 | 52,560 | -21,822 | 31,396 | |
| Comprehensive income for the period | - | - | -2,218 | -2,218 | |
| Closing balance as of July 31, 2012 | 657 | 52,560 | -24,040 | 29,177 | |
| Opening balance as of May 1, 2012 | 657 | 52,560 | -21,822 | 31,396 | |
| Comprehensive income for the period | - | - | -8,310 | -8,310 | |
| New share issue | 282 | 13,800 | - | 14,082 | |
| Issue expenses | - | -528 | - | -528 | |
| Closing balance as of April 30, 2013 | 939 | 65,832 | -30,131 | 36,640 | |
| Opening balance as of May 1, 2013 | 939 | 65,832 | -30,131 | 36,640 | |
| Comprehensive income for the period | - | - | -2,092 | -2,092 | |
| Closing balance as of July 31, 2013 | 939 | 65,832 | -32,224 | 34,547 |
Consolidated Cash flow statement
| 2013 | 2012 | 2012/13 | |
|---|---|---|---|
| € thousands | May-July | May-July | May-April |
| Operating activities | |||
| Operating income before financial items | -1,950 | -2,104 | -7,759 |
| Depreciation/amortization | 143 | 147 | 584 |
| Disposals of tangible assets | - | - | 10 |
| Adjustments for income from divestiture of intangible assets | - | - | -181 |
| Interest received | 10 | 0 | 67 |
| Interest paid | 0 | -5 | -70 |
| Cash flow from operating activities before working capital changes | -1,797 | -1,962 | -7,349 |
| Change in working capital | |||
| Change in inventories | - | -69 | -69 |
| Change in other current receivables | 197 | -47 | -246 |
| Change in trade payables | -374 | -820 | -367 |
| Change in other current liabilities | 119 | 45 | 47 |
| Cash flow from operating activities | -1,855 | -2,852 | -7,983 |
| Investing activities | |||
| Investments in intangible fixed assets | -911 | -2,211 | -6,843 |
| Divestiture of intangible fixed assets | - | - | 486 |
| Investments in property, plant and equipment | -3 | -203 | -508 |
| Cash flow from investing activities | -915 | -2,414 | -6,865 |
| Financing activities | |||
| Decrease in liabilities to credit institutions | - | -367 | -367 |
| New share issue | - | - | 14,082 |
| Issue expenses | - | - | -528 |
| New loans | - | 7,462 | 9,184 |
| Repayment of loans | - | -528 | -528 |
| Cash flow from financing activities | 0 | 6,567 | 21,843 |
| Cash flow for the period | -2,770 | 1,300 | 6,995 |
| Cash and cash equivalents at the beginning of the period | 7,228 | 233 | 233 |
| Cash and cash equivalents at the end of the period | 4,458 | 1,533 | 7,228 |
Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2013
MORE PROJECTS INITIATED WITH THE XR-17 TECHNOLOGY
FIRST QUARTER May 1 – July 31, 2013
- Consolidated Net sales amounted to TSEK 0 (0) 2
- Operating income amounted to TSEK -16,985 (-18,329)
- Net income after tax amounted to TSEK -18,224 (-19,323)
- Earnings per share amounted to SEK -0.22 (-0.33)
- Comprehensive income amounted to TSEK -18,224 (-19,323)
- Oasmia initiated pre-clinical studies with OAS-19 which is the first pharmaceutical project containing two active cytostatics in one infusion based on the company's unique technology platform XR-17
- Oasmia started a clinical program Paclical® for treatment of breast cancer
- The SEDA agreement with YA Global Master SPV Ltd expired on July 21, 2013 and was not extended
CEO COMMENTS:
"The patented technology XR-17 is the heart of our R&D and during the period, we were able to continue the clinical program with Paclical® as well as initiate development of OAS-19, which is a new and unique product candidate for combination therapies with two cytostatics in one infusion, for treatment of the most common cancer indications. We also saw a growing interest for our technology among prominent pharmaceutical companies", says Julian Aleksov, CEO of Oasmia.
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.
The numbers in brackets concern results from the corresponding period of the previous year
BUSINESS ACTIVITIES
HUMAN HEALTH
Oasmia's research and development in human health is mainly focused on the common cancer indications ovarian, breast and prostate.
Paclical®
Paclical® is a patented formulation of the commonly used substance 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 790, and the final patient was treated in the beginning of 2013. All patients are now being followed up regarding time to progression. When these data has been evaluated, Oasmia aims to submit marketing authorization applications for Paclical®, for the treatment of ovarian cancer, in the EU, the US and ROW.
In September 2012, Oasmia submitted an application for market authorization for Paclical® in Russia, which is currently being processed by the pharmaceutical authorities in the country.
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 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. Oasmia's unique micellar drug delivery system XR-17 allows the combination of agents with unequal solubility properties or low solubility. This concept provides Oasmia with a new platform for further pharmaceutical development of multiple active substances in one micelle. Recent preclinical studies have shown promising results, and the company plans to start clinical studies with OAS-19 in 2014.
| PRODUCT CANDIDATE |
INDICATION | PRE-CLINICAL | PHASE I | PHASE II | PHASE III | REGISTRATION |
|---|---|---|---|---|---|---|
| Paclical® | Ovarian cancer | |||||
| Doxophos® | Breast cancer | |||||
| Docecal ® | Breast/prostate cancer |
|||||
| OAS-19 | Various cancers |
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 the two most 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 three 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 comprising 50 dogs. One parameter in the study is time to progression. When such data have been collected and analyzed, 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 the most common cancer indication in dogs. Doxophos® Vet has been granted a MUMS designation (see below) in the USA for the indication lymphoma.
Oasmia is currently finalizing a Phase I study for Doxophos® Vet which will comprise around 15 dogs.
| PRODUCT CANDIDATE |
INDICATION | PRE-CLINICAL | PHASE I | PHASE II | PHASE III | REGISTRATION |
|---|---|---|---|---|---|---|
| Paccal® Vet | Mastocytoma | |||||
| Doxophos® Vet | Lymphoma |
THE COMPANY 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
The SEDA agreement was not extended
Oasmia has had a SEDA agreement (standby equity distribution agreement) with YA Global Master SPV Ltd which expired on July 21, 2013. The agreement was never utilized and no extension was made.
Share price development during 2013 (SEK)
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013 | 2012 | 2012/13 | |
|---|---|---|---|
| TSEK | May-July | May-July | May-April |
| Net sales | - | - | - |
| Capitalized development cost | 6,824 | 9,789 | 48,635 |
| Operating income | -16,985 | -18,329 | -67,583 |
| Net income after tax | -18,224 | -19,323 | -72,381 |
| Earnings per share (SEK), before and after dilution* | -0.22 | -0.33 | -1.06 |
| Comprehensive income for the period | -18,224 | -19,323 | -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.
FIRST QUARTER May 1 – July 31, 2013
Net sales Oasmia had no net sales in the quarter (-).
Capitalized development cost
Capitalized development cost amounted to TSEK 6,824 (9,789) and concerned mainly Paclical®. Paccal® Vet was also included with TSEK 2,266 (-). The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials in Phase III for Paclical®.
Other operating income
Other operating income amounted to TSEK 4,299 (31) and consisted mainly of an insurance compensation amounting to TSEK 4,250.
Operating expenses
Operating expenses excluding depreciation and impairment were by and large unchanged compared to the previous year and amounted to TSEK 26,862 (26,872).
The number of employees at the end of the quarter was 76, which was unchanged compared to the same period in the previous year.
Income for the quarter Net income was TSEK -18,224 (-19,323). The increase is attributable to an insurance compensation.
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 -16,161 (-24,847). The improvement consisted of an insurance compensation and a lowered level of payments to suppliers compared to the previous year.
Cash flow from investing activities amounted to TSEK -7,967 (-21,028). The decreases 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 7,938 (19,263), consisting of capitalized development costs TSEK 6,824 (9,789) and patents and other intangible assets TSEK 1,114 (9,474).
Of these, only TSEK 28 (1,765) were investments in property, plant and equipment.
Financing
Financing in the quarter 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 quarter amounted to TSEK 38,829 (13,356). The interest-bearing liabilities were TSEK 105,000 (90,000).
At the end of the quarter, unutilized credits with bank and the principal owner Alceco International S.A amounted to TSEK 5,000 (5,000) and TSEK 40,000 (25,000) respectively.
Equity at the end of the quarter amounted to TSEK 300,929 (254,150), the equity/assets ratio was 71 % (68 %) and the net debt/equity ratio was 22 % (30 %).
The parent company
The parent company´s net sales amounted to TSEK 0 (0) and net income before tax amounted to TSEK -18,207 (-19,345). The parent company's liquid assets at the end of the quarter amounted to TSEK 38,819 (13,348).
| 2013 | 2012 | 2012/13 | |
|---|---|---|---|
| May-July | May-July | May-April | |
| Number of shares at the close of the period (in thousands), before and after | |||
| dilution * | 81,772 | 58,214 | 81,772 |
| Weighted average number of shares (in thousands) before and after dilution* | 81,772 | 58,214 | 68,605 |
| Earnings per share in SEK, before and after dilution* | -0.22 | -0.33 | -1.06 |
| Equity per share, SEK* | 3.68 | 4.37 | 3.90 |
| Equity/Assets ratio, % | 71 | 68 | 72 |
| Net debt, TSEK | 66,171 | 76,644 | 42,044 |
| Net debt/Equity ratio, % | 22 | 30 | 13 |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 76 | 76 | 75 |
Key ratios and other information
*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 | 2012/13 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Net sales | - | - | - | |
| Capitalized development cost | 6,824 | 9,789 | 48,635 | |
| Other operating income | 4,299 | 31 | 2,524 | |
| Raw materials, consumables and goods for resale | -1,083 | -1,823 | -6,137 | |
| Other external expenses | -13,982 | -14,035 | -65,022 | |
| Employee benefit expenses | -11,797 | -11,014 | -42,408 | |
| Depreciation/amortization and impairment | -1,247 | -1,278 | -5,089 | |
| Other operating expenses | - | - | -86 | |
| Operating income | -16,985 | -18,329 | -67,583 | |
| Financial income | 85 | 2 | 587 | |
| Financial expenses | -1,324 | -997 | -5,384 | |
| Financial items, net | -1,239 | -995 | -4,798 | |
| Income before taxes | -18,224 | -19,323 | -72,381 | |
| Taxes | 2 | - | - | - |
| Income for the period | -18,224 | -19,323 | -72,381 | |
| Income for the period attributable to: | ||||
| Shareholders of the Parent company | -18,224 | -19,323 | -72,381 | |
| Earnings per share before and after dilution, SEK | -0.22 | -0.33 | -1.06 |
Consolidated Statement of Comprehensive income
| 2013 | 2012 | 2012/13 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Income for the period | -18,224 | -19,323 | -72,381 | |
| Comprehensive income for the period | -18,224 | -19,323 | -72,381 | |
| Comprehensive income for the period attributable to: Shareholders of the Parent company |
-18,224 | -19,323 | -72,381 | |
| Comprehensive Earnings per share before and after dilution, SEK | -0.22 | -0.33 | -1.06 |
Consolidated statement of financial position
| TSEK | Not | 2013-07-31 | 2012-07-31 | 2013-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 25,182 | 26,694 | 26,161 | |
| Capitalized development cost | 3 | 345,651 | 299,980 | 338,826 |
| Other intangible assets | 11,168 | 27,533 | 1,294 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 382,003 | 354,208 | 375,283 | |
| Current assets | ||||
| Inventories | 887 | 887 | 887 | |
| Other current receivables | 1,946 | 1,666 | 2,314 | |
| Prepaid expenses and accrued income | 2,390 | 2,648 | 3,737 | |
| Liquid assets | 38,829 | 13,356 | 62,956 | |
| Total Current assets | 44,052 | 18,557 | 69,895 | |
| TOTAL ASSETS | 426,055 | 372,765 | 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 | -280,687 | -209,405 | -262,463 | |
| Total equity | 300,929 | 254,150 | 319,153 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 891 | 16,264 | 891 | |
| Total Non-current liabilities | 891 | 16,264 | 891 | |
| Current liabilities | ||||
| Short-term borrowings | 4 | 105,000 | 90,000 | 105,000 |
| Trade payables | 3,823 | 3,138 | 7,084 | |
| Other current liabilities | 1,615 | 1,559 | 1,566 | |
| Accrued expenses and prepaid income | 13,797 | 7,654 | 11,484 | |
| Total Current liabilities | 124,235 | 102,351 | 125,134 | |
| Total Liabilities | 125,126 | 118,615 | 126,025 | |
| TOTAL EQUITY AND LIABILITIES | 426 055 | 372,765 | 445,178 | |
| Contingent liabilities Pledged assets |
5 5 |
|||
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | ||||
|---|---|---|---|---|
| TSEK | Share capital | Other capital provided |
Retained earnings |
Total equity |
| Opening balance as of May 1, 2012 | 5,724 | 457,832 | -190,082 | 273,474 |
| Comprehensive income for the period | - | - | -19,323 | -19,323 |
| Closing balance as of July 31, 2012 | 5,724 | 457,832 | -209,405 | 254,150 |
| 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 | - | - | -18,224 | -18,224 |
| Closing balance as of July 31, 2013 | 8,177 | 573,439 | -280,687 | 300,929 |
Consolidated Cash flow statement
| 2013 | 2012 | 2012/13 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Operating activities | ||||
| Operating income before financial items | -16,985 | -18,329 | -67,583 | |
| Depreciation/amortization | 1,247 | 1,278 | 5,089 | |
| Disposals of tangible assets | - | - | 86 | |
| Adjustments for income from divestiture of intangible assets | - | - | -1,579 | |
| Interest received | 85 | 2 | 587 | |
| Interest paid | -1 | -43 | -611 | |
| Cash flow from operating activities before working capital changes | -15,654 | -17,092 | -64,010 | |
| Change in working capital | ||||
| Change in inventories | - | -597 | -597 | |
| Change in other current receivables | 1,715 | -405 | -2,142 | |
| Change in trade payables | -3,261 | -7,144 | -3,197 | |
| Change in other current liabilities | 1,039 | 392 | 408 | |
| Cash flow from operating activities | -16,161 | -24,847 | -69,539 | |
| Investing activities | ||||
| Investments in intangible fixed assets | -7,938 | -19,263 | -59,603 | |
| Divestiture of intangible fixed assets | - | - | 4,235 | |
| Investments in property, plant and equipment | -28 | -1,765 | -4,428 | |
| Cash flow from investing activities | -7,967 | -21,028 | -59,795 | |
| Financing activities | ||||
| Decrease in liabilities to credit institutions | - | -3,197 | -3,197 | |
| New share issue | - | - | 122,658 | |
| Issue expenses | - | - | -4,598 | |
| New loans | 4 | - | 65,000 | 80,000 |
| Repayment of loans | - | -4,600 | -4,600 | |
| Cash flow from financing activities | 0 | 57,203 | 190,263 | |
| Cash flow for the period | -24,128 | 11,328 | 60,928 | |
| Cash and cash equivalents at the beginning of the period | 62,956 | 2,028 | 2,028 | |
| Cash and cash equivalents at the end of the period | 38,829 | 13,356 | 62,956 |
Parent Company Income statement
| 2013 | 2012 | 2012/13 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-April |
| Net sales | - | - | - | |
| Capitalized development cost | 6,824 | 9,789 | 48,635 | |
| Other operating income | 4,299 | 31 | 2,524 | |
| Raw materials, consumables and goods for resale | -1,083 | -1,823 | -6,137 | |
| Other external expenses | -13,967 | -14,006 | -64,916 | |
| Employee benefit expenses | -11,797 | -11,014 | -42,408 | |
| Depreciation/amortization and impairment of property, plant, equipment and intangible assets |
-1,245 | -1,274 | -5,074 | |
| Other operating expenses | - | - | -86 | |
| Operating income | -16,968 | -18,296 | -67,461 | |
| Result from participations in Group companies | - | -55 | -145 | |
| Other interest revenues and similar revenues | 85 | 2 | 587 | |
| Interest cost and similar costs | -1,324 | -997 | -5,384 | |
| Financial items, net | -1,239 | -1,049 | -4,942 | |
| Income after financial items | -18,207 | -19,345 | -72,404 | |
| Taxes | 2 | - | - | - |
| Income for the period | -18,207 | -19,345 | -72,404 |
Parent Company Balance Sheet
| TSEK | Note | 2013-07-31 | 2012-07-31 | 2013-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 345,651 | 299,980 | 338,826 |
| similar rights Property, plant and equipment |
11,164 | 27,515 | 10,288 | |
| Equipment, tools, fixtures and fittings | 19,377 | 23,100 | 20,355 | |
| Construction in progress and advance payments for property, plant and equipment |
5,805 | 3,594 | 5,805 | |
| Financial assets | ||||
| Participations in group companies | 110 | 110 | 110 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 382,107 | 354,299 | 375,386 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 887 | 887 | 887 | |
| 887 | 887 | 887 | ||
| Current receivables Other current receivables |
1,945 | 1,665 | 2,312 | |
| Prepaid expenses and accrued income | 2,374 | 2,600 | 3,721 | |
| 4,319 | 4,265 | 6,033 | ||
| Cash and bank balances | 38,819 | 13,348 | 62,947 | |
| Total current assets | 44,025 | 18,500 | 69,867 | |
| TOTAL ASSETS | 426,132 | 372,800 | 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 | -18,207 | -19,345 | -72,404 | |
| 287,977 | 243,636 | 306,184 | ||
| Total equity | 300,774 | 253,980 | 318,981 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 891 | 16,264 | 891 | |
| Total non-current liabilities | 891 | 16,264 | 891 | |
| Current liabilities | ||||
| Short term borrowings | 4 | 105,000 | 90,000 | 105,000 |
| Trade payables | 3,823 | 3,138 | 7,084 | |
| Liabilities to group companies | 232 | 205 | 247 | |
| Other current liabilities | 1,615 | 1,559 | 1,566 | |
| Accrued expenses and prepaid income | 13,797 | 7,654 | 11,484 | |
| Total Current liabilities | 124,467 | 102,555 | 125,381 | |
| TOTAL EQUITY AND LIABILITIES | 426,132 | 372,800 | 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 | - | - | -19,345 | -19,345 |
| Closing balance as of July 31, 2012 | 5,724 | 4,620 | 243,636 | 253,980 |
| 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 | - | - | -18,207 | -18,207 |
| Closing balance as of July 31, 2013 | 8,177 | 4,620 | 287,977 | 300,774 |
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. 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 317,975 (247,623) and the Parent Company has similar amounting to TSEK 308,400 (238,154). 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 | 2013-07-31 | 2012-07-31 | 2013-04-30 |
|---|---|---|---|
| Paclical® | 259,034 | 218,929 | 254,475 |
| Paccal® Vet | 86,617 | 81,051 | 84,351 |
| Total | 345,651 | 299,980 | 338,826 |
Note 4 Transactions with related parties
No significant transactions with related parties have been performed in the period.
As of July 31, 2013 Oasmia had a credit facility of TSEK 40,000 (25,000) provided by the principal owner of the company, Alceco International SA. The interest rate on utilized credits is 5 %. As of July 31, 2013, this credit was completely unutilized (also as of July 31, 2012).
On July 31, 2013, Oasmia carried a loan from its second largest owner Nexttobe AB amounting to TSEK 105,000 (90,000). The interest rate is 5 % and will be paid in its entirety when the loan is due for repayment on December 31, 2013. As of July 31, 2013, the accrued interest cost for the borrowing was TSEK 6,376 (1,253).
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 Interimreport gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Comp any and the companies that are part of the Group face.
Uppsala, September 6, 2013
Joel Citron,Chairman Martin Nicklasson,Member
Jan Lundberg,Member Prof. Dr.Horst Domdey,Member
Bo Cederstrand, Member Julian Aleksov,Member and Chief ExecutiveOfficer
The information in this interim report is such that Oasmia Pharmaceutical (publ) must publish according to the code of trade in financial instruments. The information was delivered for publication on September 6, 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.
This report has not been reviewed by the company auditors.
COMPANY INFORMATION OasmiaPharmaceutical 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: Mikae[email protected]
UPCOMING REPORT DATES
| Interim report May – October 2013 | 2013-12-05 |
|---|---|
| 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 |