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Vivesto — Interim / Quarterly Report 2014
Jun 5, 2014
3124_10-k_2014-06-05_b69b322b-0719-46fe-bebb-cd6795c21406.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Year-end report for the fiscal year May 2013 - April 2014 €
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 11-25. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per April 30, 2014 which was 9.0674 SEK per one EUR. When occasional figures are in SEK or USD it is because the amount is very firmly denominated in that currency.
CONDITIONAL APPROVAL FOR OASMIA'S FIRST PHARMA-CEUTICAL PRODUCT PACCAL® VET-CA1
FOURTH QUARTER February 1 – April 30, 2014
- Consolidated Net sales amounted to € 2 thousand (-) 1
- Operating income amounted to € -3,886 thousand (-2,417)
- Net income after tax amounted to € -4,168 thousand (-2,531)
- Earnings per share amounted to € -0.05 (-0.03)
- Comprehensive income amounted to € -4,168 thousand (-2,531)
- Conditional FDA approval for Paccal® Vet
- MSEK 72 private placement completed
- MSEK 40 bank loan received
THE FISCAL YEAR May 1, 2013 – April 30, 2014
- Consolidated Net sales amounted to € 7 thousand (-)
- Operating income amounted to € -10,818 thousand (-7,453)
- Net income after tax amounted to € -11,592 thousand (-7,983)
- Earnings per share amounted to € -0.14 (-0.12)
- Comprehensive income amounted to € -11,592 thousand (-7,983)
- Increased funding of loans
- FDA approved Oasmia's production facility
- Oasmia initiated a clinical program for treatment of breast cancer with Paclical®
- Oasmia initiated pre-clinical studies with OAS-19, which is the first pharmaceutical project with a combination of two active cytostatics in one infusion.
The numbers in parentheses show the results from the corresponding period of the previous year
• The Board does not propose a dividend for the past fiscal year
EVENTS AFTER THE CLOSING DAY
- The Swedish Medical Products Agency approved Oasmia's production facility
- First shipment of Paccal Vet-CA1 to Abbott Animal Health was accomplished
- Paccal Vet-CA1 and XR-17 is presented at ACVIM Forum in Nashville
CEO COMMENTS:
"The conditional approval of Paccal Vet-CA1 in the USA was a milestone for Oasmia and, together with our US American partner Abbott Animal Health, we are now working on the market preparations, with the first shipment to Abbott already made. There will be oral abstracts and symposia related to Paccal Vet-CA1 and to our technology XR-17 at the ACVIM Forum, which is arranged by the American College of Veterinary Internal Medicine and is being held July 4-7 in Nashville, Tennessee. Beyond that we have also successfully continued the development of our other pharmaceutical candidates", 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.
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 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, and all patients have then been followed up regarding time to progression. Oasmia is now evaluating the results, which will be used for submission of marketing authorization applications for Paclical in the EU, the US and the rest of the world.
In September 2012, Oasmia submitted an application for market authorization for Paclical in Russia, which is currently being processed by the local pharmaceutical authorities.
Oasmia started a dose finding study with Paclical for weekly treatment of breast cancer in the summer of 2013.
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 a clinical Phase I study.
Docecal®
Docecal is a patented formulation of the cytostatic docetaxel in combination with XR-17. Oasmia is preparing the 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 another 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. The company still intends to start validation of the production of OAS-19 in 2014.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASEI | PHASE II | PHASE III | REG./ | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paciical® (paclitaxel) |
Ovarian cancer | Ongoing | Global (ex RUS/CIS) |
oasmia | ||||
| In Registration | RUS/CIS | PHARMASYNTEZ | ||||||
| Metastatic breast cancer |
Ongoing | Global | oasmia | |||||
| Doxophos ® (doxorubicin) |
Breast cancer | Ongoing | Global | oasmia | ||||
| Docecal® (docetaxel) |
Breast cancer | Ongoing | Global | oasmia | ||||
| OAS-19 (combination) |
Various cancers | Ongoing | Global | oasmia |
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 has two pharmaceutical candidates in this area.
Paccal Vet-CA1
Paccal Vet-CA1 is a patented formulation of paclitaxel, in combination with XR-17. We are anticipating that Paccal Vet-CA1 will be the first injectable chemotherapeutic product marketed for treatment of solid tumours in dogs.
Oasmia has been granted MUMS designation (see below) by the American Food and Drug Administration (FDA) in the USA for Paccal Vet-CA1 in treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma.
Oasmia was granted conditional approval of Paccal Vet-CA1 for treatment of mammary carcinoma and squamous cell carcinoma in February 2014.
The company is conducting a complementary study on Paccal Vet-CA1 for treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs which have been treated 4 times with three week intervals. All 50 randomized dogs were treated in the quarter which ended in April 2014. If the result corresponds to the expectations, Oasmia will submit an application for market approval for Paccal Vet-CA1 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, which is one of the most common cancers 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. 12 dogs have been treated in May 2014 and Oasmia aims to publish a study report in the autumn of 2014.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE1 | PHASE II | PHASE III | REG. | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paccal ® Vet (paclitaxel) |
Mammary/ squareous cell |
Approved (Feb 2014) |
Global (ex-RUS/JAP) |
Abbott Arimal Health |
||||
| Mast cell | Ongoing | Global (ex-RUS/JAP) |
Abbott Animal Health |
|||||
| Doxophos 3 Vet (doxorubicin) |
Lymphoma. | Ongoing | Planned | Global | Abbott Animal Health |
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
MSEK 72 private placement completed
In March 2014 Oasmia carried out a MSEK 72 private placement which provided the company with MSEK 68 after issue expenses. The placement was directed at a number of international institutional investors and investors in Sweden. In total 3,800,000 shares were issued to a price of SEK 19 per share. After the placement, the number of shares and votes amounted to 85,572,330. The increase in shares was 4.65 %.
MSEK 40 bank loan received
In March 2014, Oasmia was granted a new MSEK 40 bank loan with a term April 1 – August 31, 2014. The loan replaced a previous MSEK 40 bank loan which was due on March 31, 2014.
Increased funding of loans
In December 2013, the existing loan from Nexttobe AB was extended by one year from December 31, 2013 to December 31, 2014. The interest in 2014 is 8.5 % and it shall be paid in full on December 31, 2014. In addition, Oasmia was in November 2013 granted a new MSEK 40 bank loan which had a term of December 1, to March 31, 2014.
FDA approved Oasmia's production facility
In December 2013, Oasmia announced that the company's production facility in Uppsala has successfully passed a Pre-Approval Inspection by the FDA. The FDA has thus confirmed that Oasmia's manufacturing of Paccal Vet-CA1 meets the requirements of cGMP (current Good Manufacturing Practice).
Warrants
At the Annual General Meeting in September 2013, a resolution was made to offer the company Board of Directors and management the right to acquire warrants in Oasmia Pharmaceutical AB. Subscription of shares supported by warrants must be performed between January 1 and August 15, 2014. As of April 30 2014 no acquisitions of warrants were made.
EVENTS AFTER CLOSING DAY
The Swedish Medicinal Products Agency approved Oasmia's production facility In May 2014, the Swedish Medicinal Products Agency approved Oasmia's production facility in Uppsala concerning manufacture and sales in the EU. Oasmia now has a fully approved production facility for manufacture of their products for the European market.
First shipment of Paccal Vet-CA1 to Abbott Animal Health was accomplished In May 2014, Oasmia made its first shipment of Paccal Vet-CA1 to Abbott Animal Health in the USA.
Paccal Vet-CA1 and XR-17 is presented at ACVIM Forum in Nashville
American College of Veterinary Internal Medicine arranges the ACVIM Forum in Nashville, Tennesse, June 4-7. There will be oral abstracts and symposiums related to Paccal Vet-CA1 and Oasmia´s patented excipient XR-17.
Share price development during the year (SEK)
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| € thousands | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | 2 | - | 7 | - | |
| Capitalized development cost | 2 | 923 | 965 | 3,249 | 5,098 |
| Operating income | -3,886 | -2,417 | -10,818 | -7,453 | |
| Net income after tax | -4,168 | -2,531 | -11,592 | -7,983 | |
| Earnings per share (€), before and after dilution* | -0.05 | -0.03 | -0.14 | -0.12 | |
| Comprehensive income for the period | -4,168 | -2,531 | -11,592 | -7,983 |
*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.
FOURTH QUARTER February 1 – April 30 2014
Net sales Net sales amounted to € 2 thousand (-).
Capitalized development cost
Capitalized development costs, which concerns Phase III clinical trials, amounted to € 923 thousand (965). Of the capitalization, Paclical comprised € 540 thousand (720) and Paccal Vet-CA1 comprised € 383 thousand (245).
Operating expenses
Operating expenses excluding depreciation and impairment were significantly higher compared to the corresponding quarter of the previous year and amounted to € 4,685 thousand (3,246). The nature of the operating expenses has changed. The costs for clinical trials have decreased to some degree, but costs related to preparations for the commercial phase Oasmia is planning for has increased significantly more. The latter refers to among other things method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
Income for the quarter
Net income was € -4,168 thousand (-2,531). The decrease between these two quarters was attributable to significantly increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III.
THE FISCAL YEAR May 1, 2013 – April 30, 2014
Net sales
Net sales amounted to € 7 thousand (-) and concerned sales of supplies.
Capitalized development cost
Capitalized development costs, which concerns Phase III clinical trials, amounted to € 3,249 thousand (5,098). The larger part concerned Paclical which was capitalized with € 2,170 thousand (4,589) and a smaller part concerning Paccal Vet-CA1 which contributed with € 1,079 thousand (509). The decrease compared to the previous year can be attributed to decreased costs for clinical trials for Paclical.
Other operating income
Other operating income amounted to € 491 thousand (278) and mainly resulted from an insurance compensation for a production disruption amounting to € 469 thousand.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to € 14,020 thousand (12,269). The nature of the operating expenses has changed. The costs for clinical trials have decreased, but costs related to preparations for the commercial phase Oasmia is planning for has increased more. The latter refers to, among others, method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
The number of employees at the end of the year was 78 (75).
Income for the year
Net income was € -11,592 thousand (-7,983). The decrease was to a smaller extent attributable to increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III 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 € -9,584 thousand (-7,935).
Cash flow from investing activities amounted to € -3,935 thousand (-6,329). 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 € 3,699 thousand (6,308), consisting of capitalized development costs € 3,249 thousand (5,098) and patents and other intangible assets € 450 thousand (1,210).
Of these, € 236 thousand (488) were investments in property, plant and equipment, mostly production equipment.
Financing
Financing in the period May – December 2013 was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012 and a € 469 thousand insurance compensation. During the period December 2013 – March 2014 financing was performed by a € 4,411 thousand bank loan. During the period March – April 2014, financing was performed by liquid assets provided to the company by the private placement which was completed in March 2014.
Financial position
The consolidated liquid assets at the end of the year amounted to € 5,320 thousand (6,943). The interest-bearing liabilities were € 15,991 thousand (11,580).
At the end of the year, unutilized credits with banks amounted to € 551 thousand (551) and with the principal owner Alceco International S.A. € 4,411 thousand (4,411).
Equity at the end of the year amounted to € 31,090 thousand (35,198), the equity/assets ratio was 60 % (70 %) and the net debt/equity ratio was 34 % (13 %).
The parent company
The parent company´s net sales amounted to € 7 thousand (-) and net income before tax amounted to € -11,594 thousand (-7,985). The parent company's liquid assets at the end of the period amounted to € 5,320 thousand (6,942).
Future financing
Oasmia now has one product approved but not a sufficient cash flow from operations. For this reason Oasmia continuously work with various financing alternatives. Available consolidated cash and cash equivalent as well and unutilized credit facilities are, as of April 30, are not sufficient to fund the operations during the next 12 months. In light of available financing 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 the next 12 months.
Key ratios and other information
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| Note | Feb-April | Feb-April | May-April | May-April | |
| Number of shares at the close of the period (in thousands), before and | |||||
| after dilution* | 85,572 | 81,772 | 85,572 | 81,772 | |
| Weighted average number of shares (in thousands) before and after dilution* | 83,822 | 81,772 | 82,272 | 68,605 | |
| Earnings per share in €, before and after dilution* | -0.05 | -0.03 | -0.14 | -0.12 | |
| Equity per share, €* | 0.36 | 0.43 | 0.36 | 0.43 | |
| Equity/Assets ratio, % | 2 | 60 | 70 | 60 | 70 |
| Net debt, € thousand | 10,671 | 4,637 | 10,671 | 4,637 | |
| Net debt/Equity ratio, % | 34 | 13 | 34 | 13 | |
| Return on total assets, % | neg | neg | neg | neg | |
| Return on equity, % | neg | neg | neg | neg | |
| Number of employees at the end of the period | 78 | 75 | 78 | 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
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| € thousands | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | 2 | - | 7 | - | |
| Capitalized development cost | 2 | 923 | 965 | 3,249 | 5,098 |
| Other operating income | 4 | 4 | 491 | 278 | |
| Raw materials, consumables and goods for resale | -344 | -139 | -754 | -677 | |
| Other external expenses | 2 | -3,090 | -1,842 | -8,292 | -6,906 |
| Employee benefit expenses | -1,251 | -1,256 | -4,974 | -4,677 | |
| Depreciation/amortization and impairment | -131 | -140 | -545 | -561 | |
| Other operating expenses | 0 | -10 | 0 | -10 | |
| Operating income | -3,886 | -2,417 | -10,818 | -7,453 | |
| Financial income | 5 | 30 | 21 | 65 | |
| Financial expenses | -286 | -144 | -795 | -594 | |
| Financial items, net | -281 | -114 | -774 | -529 | |
| Income before taxes | -4,168 | -2,531 | -11,592 | -7,983 | |
| Taxes | 3 | - | - | - | - |
| Income for the period | -4,168 | -2,531 | -11,592 | -7,983 | |
| Income for the period attributable to: | |||||
| Shareholders of the Parent company | -4,168 | -2,531 | -11,592 | -7,983 | |
| Earnings per share, before and after dilution, € | -0.05 | -0.03 | -0.14 | -0.12 |
Consolidated Statement of comprehensive income
| 2014 | 2013 | 2013/14 | 2012/13 | |
|---|---|---|---|---|
| € thousands | Feb-April | Feb-April | May-April | May-April |
| Income for the period | -4,168 | -2,531 | -11,592 | -7,983 |
| Comprehensive income for the period | -4,168 | -2,531 | -11,592 | -7,983 |
| Comprehensive income for the period attributable to: | ||||
| Shareholders of the Parent company | -4,168 | -2,531 | -11,592 | -7,983 |
| Comprehensive Earnings per share, before and after dilution, € | -0.05 | -0.03 | -0.14 | -0.12 |
Consolidated statement of financial position
| € thousands | Note | 2014-04-30 | 2013-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 2,691 | 2,885 | |
| Capitalized development cost | 2,4 | 41,509 | 38,259 |
| Other intangible assets | 1,470 | 1,135 | |
| Financial assets | 0 | 0 | |
| Total Non-current assets | 45,670 | 42,280 | |
| Current assets | |||
| Inventories | 183 | 98 | |
| Trade receivables | 5 | - | |
| Other current receivables | 301 | 255 | |
| Prepaid expenses and accrued income | 177 | 412 | |
| Liquid assets | 5,320 | 6,943 | |
| Total Current assets | 5,986 | 7,708 | |
| TOTAL ASSETS | 51,656 | 49,988 | |
| EQUITY | |||
| Capital and provisions attributable to shareholders of the Parent Company | |||
| Share capital | 944 | 902 | |
| Other capital provided | 70,684 | 63,242 | |
| Retained earnings | -40,538 | -28,946 | |
| Total Equity | 31,090 | 35,198 | |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 98 | 98 | |
| Total Non-current liabilities | 98 | 98 | |
| Current liabilities | |||
| Liabilities to credit institutions | 4,411 | - | |
| Short-term borrowings | 5 | 11,580 | 11,580 |
| Trade payables | 1,930 | 781 | |
| Other current liabilities | 176 | 173 | |
| Accrued expenses and prepaid income | 2 | 2,370 | 2,158 |
| Total Current liabilities | 20,467 | 14,692 | |
| Total Liabilities | 20,565 | 14,790 | |
| TOTAL EQUITY AND LIABILITIES | 51,656 | 49,988 |
Contingent liabilities and Pledged assets are presented in note 6.
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | ||||||||
|---|---|---|---|---|---|---|---|---|
| € thousands | Share capital | Other capital provided |
Retained earnings |
Total equity | ||||
| Opening balance as of May 1, 2012 | 631 | 50,492 | -20,963 | 30,160 | ||||
| Comprehensive income for the period | - | - | -7,983 | -7,983 | ||||
| New share issue | 271 | 13,257 | - | 13,527 | ||||
| Issue expenses | - | -507 | - | -507 | ||||
| Closing balance as of April 30, 2013 | 902 | 63,242 | -28,946 | 35,198 | ||||
| Opening balance as of May 1, 2013 | 902 | 63,242 | -28,946 | 35,198 | ||||
| Comprehensive income for the period | - | - | -11,592 | -11,592 | ||||
| New share issue | 42 | 7,921 | - | 7,963 | ||||
| Issue expenses | - | -478 | - | -478 | ||||
| Closing balance as of April 30, 2014 | 944 | 70,684 | -40,538 | 31,090 |
Consolidated Cash flow statement
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| € thousands | Note | Feb-April | Feb-April | May-April | May-April |
| Operating activities | |||||
| Operating income before financial items | -3,886 | -2,417 | -10,818 | -7,453 | |
| Depreciation/amortization | 131 | 140 | 545 | 561 | |
| Disposals of tangible and intangible assets | 0 | 10 | 0 | 10 | |
| Adjustments for income from divestiture of intangible assets | - | - | - | -174 | |
| Interest received | 5 | 30 | 21 | 65 | |
| Interest paid | -61 | -3 | -68 | -67 | |
| Cash flow from operating activities before working capital changes | -3,812 | -2,241 | -10,319 | -7,059 | |
| Change in working capital | |||||
| Change in inventories | - | - | -85 | -66 | |
| Change in trade receivables | 1 | - | -5 | - | |
| Change in other current receivables | 190 | -178 | 190 | -236 | |
| Change in trade payables | 1,135 | 292 | 1,149 | -353 | |
| Change in other current liabilities | 2 | -435 | -136 | -513 | -220 |
| Cash flow from operating activities | -2,920 | -2,263 | -9,584 | -7,935 | |
| Investing activities | |||||
| Investments in intangible fixed assets | 2 | -1,062 | -965 | -3,699 | -6,308 |
| Divestiture of intangible fixed assets | - | - | - | 467 | |
| Investments in property, plant and equipment | -207 | -9 | -236 | -488 | |
| Cash flow from investing activities | -1,270 | -974 | -3,935 | -6,329 | |
| Financing activities | |||||
| Increase in liabilities to credit institutions | 4,411 | - | 8,823 | - | |
| Decrease in liabilities to credit institutions | -4,411 | - | -4,411 | -353 | |
| New share issue | 7,963 | - | 7,963 | 13,527 | |
| Issue expenses | -478 | -4 | -478 | -507 | |
| New loans | - | - | - | 8,823 | |
| Repayment of loans | - | - | - | -507 | |
| Cash flow from financing activities | 7,485 | -4 | 11,896 | 20,983 | |
| Cash flow for the period | 3,295 | -3,240 | -1,623 | 6,720 | |
| Cash and cash equivalents at the beginning of the period | 2,026 | 10,184 | 6,943 | 224 | |
| Cash and cash equivalents at the end of the period | 5,321 | 6,943 | 5,320 | 6,943 |
Oasmia Pharmaceutical AB (publ)
Year-end report for the fiscal year May 2013 - April 2014
CONDITIONAL APPROVAL FOR OASMIA'S FIRST PHARMA-CEUTICAL PRODUCT PACCAL VET-CA1
FOURTH QUARTER February 1 – April 30, 2014
- Consolidated Net sales amounted to TSEK 20 (0) 2
- Operating income amounted to TSEK -35 239 (-21 920)
- Net income after tax amounted to TSEK -37 790 (-22 953)
- Earnings per share amounted to SEK -0,45 (-0,28)
- Comprehensive income amounted to TSEK -37 790 (-22 953)
- Conditional FDA approval for Paccal® Vet-CA1
- MSEK 72private placement completed
- MSEK 40bank loan received
THE FISCAL YEAR May 1, 2013 – April 30, 2014
- Consolidated Net sales amounted to TSEK 60 (0)
- Operating income amounted to TSEK -98 091 (-67 583)
- Net income after tax amounted to TSEK -105 112 (-72 381)
- Earnings per share amounted to SEK -1,28 (-1,06)
- Comprehensive income amounted to TSEK -105 112 (-72 381)
- Increased funding of loans
- FDA approved Oasmia's production facility
- Oasmia initiated a clinical program for treatment of breast cancer with Paclical
- Oasmia initiated pre-clinical studies with OAS-19, which is the first pharmaceutical project with a combination of two active cytostatics in one infusion.
- The Board does not propose a dividend for the past fiscal year
The numbers in parentheses show the results from the corresponding period of the previous year
EVENTS AFTER THE CLOSING DAY
- The Swedish Medical Products Agency approved Oasmia's production facility
- First shipment of Paccal Vet-CA1 to Abbott Animal Health was accomplished
- Paccal Vet-CA1 and XR-17 is presented at ACVIM Forum in Nashville
CEO COMMENTS:
"The conditional approval of Paccal Vet-CA1 in the USA was a milestone for Oasmia and, together with our US American partner Abbott Animal Health, we are now working on the market preparations, with the first shipment to Abbott already made. There will be oral abstracts and symposia related to Paccal Vet-CA1 and to our technology XR-17 at the ACVIM Forum, which is arranged by the American College of Veterinary Internal Medicine and is being held July 4-7 in Nashville, Tennessee. Beyond that we have also successfully continued the development of our other pharmaceutical candidates", 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.
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 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, and all patients have then been followed up regarding time to progression. Oasmia is now evaluating the results, which will be used for submission of marketing authorization applications for Paclical in the EU, the US and the rest of the world.
In September 2012, Oasmia submitted an application for market authorization for Paclical in Russia, which is currently being processed by the local pharmaceutical authorities.
Oasmia started a dose finding study with Paclical for weekly treatment of breast cancer in the summer of 2013.
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 a clinical Phase I study.
Docecal®
Docecal is a patented formulation of the cytostatic docetaxel in combination with XR-17. Oasmia is preparing the 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 another 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. The company still intends to start validation of the production of OAS-19 in 2014.
| Human Health | |
|---|---|
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASEI | PHASE II | PHASE III | REG./ | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paciical® (paclitaxel) |
Ovarian cancer | Ongoing | Global (ex RUS/CIS) |
oasmia | ||||
| In Registration | RUS/CIS | SPHARMASYNTEZ | ||||||
| Metastatic breast cancer |
Ongoing | Global | oasmia | |||||
| Doxophos ® (doxorubicin) |
Breast cancer | Ongoing | Global | oasmia | ||||
| Docecal® (docetaxel) |
Breast cancer | Ongoing | Global | oasmia | ||||
| OAS-19 (combination) |
Various cancers | Ongoing | Global | oasmia |
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 has two pharmaceutical candidates in this area.
Paccal Vet-CA1
Paccal Vet-CA1 is a patented formulation of paclitaxel, in combination with XR-17. We are anticipating on that Paccal Vet-CA1 will be the first injectable chemotherapeutic product marketed for treatment of solid tumours in dogs.
Oasmia has been granted MUMS designation (see below) by the American Food and Drug Administration (FDA) in the USA for Paccal Vet-CA1 in treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma.
Oasmia was granted conditional approval of Paccal Vet-CA1 for treatment of mammary carcinoma and squamous cell carcinoma in February 2014.
The company is conducting a complementary study on Paccal Vet-CA1 for treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs which have been treated 4 times with three week intervals. All 50 randomized dogs were treated in the quarter which ended in April 2014. If the result corresponds to the expectations, Oasmia will submit 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, which is one of the most common cancers 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. 12 dogs have been treated in May 2014 and Oasmia aims to publish a study report in the autumn of 2014.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE1 | PHASE II | PHASE III | REG. | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paccal ® Vet (paclitaxel) |
Mammary/ squareous cell |
Approved (Feb 2014) |
Global (ex-RUS/JAP) |
Abbott Arimal Health |
||||
| Mast cell | Ongoing | Global (ex-RUS/JAP) |
Abbott | |||||
| Doxophos 3 Vet (doxorubicin) |
Lymphoma. | Ongoing | Planned | Global | Abbott Animal Health |
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
MSEK 72 private placement completed
In March 2014 Oasmia carried out a MSEK 72 private placement which provided the company with MSEK 68 after issue expenses. The placement was directed at a number of international institutional investors and investors in Sweden. In total 3 800 000 shares were issued to a price of SEK 19 per share. After the placement, the number of shares and votes amounted to 85 572 330. The increase in shares was 4.65 %.
MSEK 40 bank loan received
In March 2014, Oasmia was granted a new MSEK 40 bank loan with a term April 1 – August 31 2014. The loan replaced a previous MSEK 40 bank loan which was due on March 31, 2014.
Increased funding of loans
In December 2013, the existing loan from Nexttobe AB was extended by one year from December 31, 2013 to December 31, 2014. The interest in 2014 is 8.5 % and it shall be paid in full on December 31, 2014. In addition, Oasmia was in November 2013 granted a new MSEK 40 bank loan which had a term of December 1, to March 31, 2014.
FDA approved Oasmia's production facility
In December 2013, Oasmia announced that the company's production facility in Uppsala has successfully passed a Pre-Approval Inspection by the FDA. The FDA has thus confirmed that Oasmia's manufacturing of Paccal Vet-CA1 meets the requirements of cGMP (current Good Manufacturing Practice).
Warrants
At the Annual General Meeting in September 2013, a resolution was made to offer the company Board of Directors and management the right to acquire warrants in Oasmia Pharmaceutical AB. Subscription of shares supported by warrants must be performed between January 1 and August 15, 2014. As of April 30 2014 no acquisitions of warrants were made.
EVENTS AFTER CLOSING DAY
The Swedish Medicinal Products Agency approved Oasmia's production facility In May 2014, the Swedish Medicinal Products Agency approved Oasmia's production facility in Uppsala concerning manufacture and sales in the EU. Oasmia now has a fully approved production facility for manufacture of their products for the European market.
First shipment of Paccal Vet-CA1 to Abbott Animal Health was accomplished At May 2014, Oasmia made its first shipment of Paccal Vet-CA1 to Abbott Animal Health in the USA.
Paccal Vet-CA1 and XR-17 is presented at ACVIM Forum in Nashville
American College of Veterinary Internal Medicine arranges the ACVIM Forum in Nashville, Tennesse, June 4-7. There will be oral abstracts and symposiums related to Paccal Vet-CA1 and Oasmia´s patented excipient XR-17.
Share price development during the year (SEK)
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | 20 | - | 60 | - | |
| Capitalized development cost | 2 | 8 367 | 8 748 | 29 464 | 46 229 |
| Operating income | -35 239 | -21 920 | -98 091 | -67 583 | |
| Net income after tax | -37 790 | -22 953 | -105 112 | -72 381 | |
| Earnings per share (€), before and after dilution* | -0,45 | -0,28 | -1,28 | -1,06 | |
| Comprehensive income for the period | -37 790 | -22 953 | -105 112 | -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.
FOURTH QUARTER February 1 – April 30 2014
Net sales Net sales amounted to TSEK 20 (-).
Capitalized development cost
Capitalized development costs, which concerns Phase III clinical trials, amounted to TSEK 8 367 (8 748). Of the capitalization, Paclical comprised TSEK 4 897 (6 528) and Paccal Vet-CA1 comprised TSEK 3 471 (2 220).
Operating expenses
Operating expenses excluding depreciation and impairment were significantly higher compared to the corresponding quarter of the previous year and amounted to TSEK 42 477 (29 436). The nature of the operating expenses has changed. The costs for clinical trials have decreased some degree, but costs related to preparations for the commercial phase Oasmia is planning for has increased significantly more. The latter refers to among other things method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
Income for the quarter
Net income was TSEK -37 790 (-22 953). The decrease between these two quarters was attributable to significantly increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III.
THE FISCAL YEAR May 1, 2013 – April 30, 2014
Net sales Net sales amounted to TSEK 60 (-) and concerned sales of supplies.
Capitalized development cost
Capitalized development costs, which concerns Phase III clinical trials, amounted to TSEK 29 464 (46 229). The larger part concerned Paclical which was capitalized with TSEK 19 677 (41 611) and a smaller part concerning Paccal Vet-CA1 which contributed with TSEK 9 788 (4 618). The decrease compared to the previous year can be attributed to decreased costs for clinical trials for Paclical.
Other operating income
Other operating income amounted to TSEK 4 454 (2 524) and mainly resulted from an insurance compensation for a production disruption amounting to TSEK 4 250.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to TSEK 127 128(111 247). The nature of the operating expenses has changed. The costs for clinical trials have decreased, but costs related to preparations for the commercial phase Oasmia is planning for has increased more. The latter refers to, among others, method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
The number of employees at the end of the year was 78 (75).
Income for the year
Net income was TSEK -105 112 (-72 381). The decrease was to a smaller extent attributable to increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III 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 -86 899 (-71 946).
Cash flow from investing activities amounted to TSEK -35 682 (-57 388). 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 33 545 (57 196), consisting of capitalized development costs TSEK 29 464 (46 229) and patents and other intangible assets TSEK 4 080 (10 967).
Of these, TSEK 2 138 (4 428) were investments in property, plant and equipment, mostly production equipment.
Financing
Financing in the period May – December 2013 was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012 and a TSEK 4 250 insurance compensation.
During the period December 2013 – March 2014 financing was performed by a TSEK 40 000 bank loan. During the period March – April 2014, financing was performed by liquid assets provided to the company by the private placement which was completed in March 2014.
Financial position
The consolidated liquid assets at the end of the year amounted to TSEK 48 241 (62 956). The interest-bearing liabilities were TSEK 145 000 (105 000).
At the end of the year, unutilized credits with banks amounted to TSEK 5 000 (5 000) and with the principal owner Alceco International S.A TSEK 40 000 (40 000).
Equity at the end of the year amounted to TSEK 281 907 (319 153), the equity/assets ratio was 60 % (70 %) and the net debt/equity ratio was 34 % (13 %).
The parent company
The parent company´s net sales amounted to TSEK 60 (-) and net income before tax amounted to TSEK -105 126 (-72 404). The parent company's liquid assets at the end of the fiscal year amounted to TSEK 48 238 (62 947).
Future financing
Oasmia now has one product approved but not a sufficient cash flow from operations. For this reason Oasmia continuously work with various financing alternatives. Available consolidated cash and cash equivalent as well and unutilized credit facilities are, as of April 30, are not sufficient to fund the operations during the next 12 months. In light of available financing 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 the next 12 months.
2014 2013 2013/14 2012/13 Note Feb-April Feb-April May-April May-April Number of shares at the close of the period (in thousands), before and after dilution * 85 572 81 772 85 572 81 772 Weighted average number of shares (in thousands) before and after
Key ratios and other information
| Weighted average number of shares (in thousands) before and after dilution* |
83 822 | 81 772 | 82 272 | 68 605 | |
|---|---|---|---|---|---|
| Earnings per share in SEK, before and after dilution* | -0,45 | -0,28 | -1,28 | -1,06 | |
| Equity per share, SEK* | 3,29 | 3,90 | 3,29 | 3,90 | |
| Equity/Assets ratio, % | 2 | 60 | 70 | 60 | 70 |
| Net debt, TSEK | 96 759 | 42 044 | 96 759 | 42 044 | |
| Net debt/Equity ratio, % | 34 | 13 | 34 | 13 | |
| Return on total assets, % | neg | neg | neg | neg | |
| Return on equity, % | neg | neg | neg | neg | |
| Number of employees at the end of the period | 78 | 75 | 78 | 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
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | 20 | - | 60 | - | |
| Capitalized development cost | 2 | 8 367 | 8 748 | 29 464 | 46 229 |
| Other operating income | 34 | 34 | 4 454 | 2 524 | |
| Raw materials, consumables and goods for resale | -3 120 | -1 260 | -6 835 | -6 137 | |
| Other external expenses | 2 | -28 015 | -16 700 | -75 189 | -62 616 |
| Employee benefit expenses | -11 343 | -11 389 | -45 101 | -42 408 | |
| Depreciation/amortization and impairment | -1 184 | -1 265 | -4 941 | -5 089 | |
| Other operating expenses | 0 | -86 | -3 | -86 | |
| Operating income | -35 239 | -21 920 | -98 091 | -67 583 | |
| Financial income | 41 | 274 | 192 | 587 | |
| Financial expenses | -2 592 | -1 308 | -7 213 | -5 384 | |
| Financial items, net | -2 551 | -1 034 | -7 021 | -4 798 | |
| Income before taxes | -37 790 | -22 953 | -105 112 | -72 381 | |
| Taxes | 3 | - | - | - | - |
| Income for the period | -37 790 | -22 953 | -105 112 | -72 381 | |
| Income for the period attributable to: | |||||
| Shareholders of the Parent company | -37 790 | -22 953 | -105 112 | -72 381 | |
| Earnings per share before and after dilution, SEK | -0,45 | -0,28 | -1,28 | -1,06 |
Consolidated Statement of Comprehensive income
| 2014 | 2013 | 2013/14 | 2012/13 | |
|---|---|---|---|---|
| TSEK | Feb-April | Feb-April | May-April | May-April |
| Income for the period | -37 790 | -22 953 | -105 112 | -72 381 |
| Comprehensive income for the period | -37 790 | -22 953 | -105 112 | -72 381 |
| Comprehensive income for the period attributable to: | ||||
| Shareholders of the Parent company | -37 790 | -22 953 | -105 112 | -72 381 |
| Comprehensive Earnings per share before and after dilution, SEK | -0,45 | -0,28 | -1,28 | -1,06 |
Consolidated statement of financial position
| TSEK | Note | 2014-04-30 | 2013-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 24 401 | 26 161 | |
| Capitalized development cost | 2,4 | 376 376 | 346 911 |
| Other intangible assets | 13 328 | 10 294 | |
| Financial assets | 2 | 2 | |
| Total Non-current assets | 414 106 | 383 368 | |
| Current assets | |||
| Inventories | 1 656 | 887 | |
| Trade receivables | 49 | - | |
| Other current receivables | 2 729 | 2 314 | |
| Prepaid expenses and accrued income | 1 601 | 3 737 | |
| Liquid assets | 48 241 | 62 956 | |
| Total Current assets | 54 276 | 69 895 | |
| TOTAL ASSETS | 468 383 | 453 263 | |
| EQUITY | |||
| Capital and provisions attributable to shareholders of the Parent Company | |||
| Share capital | 8 557 | 8 177 | |
| Other capital provided | 640 924 | 573 439 | |
| Retained earnings | -367 574 | -262 463 | |
| Total equity | 281 907 | 319 153 | |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 891 | 891 | |
| Total Non-current liabilities | 891 | 891 | |
| Current liabilities | |||
| Liabilities to credit institutions | 40 000 | - | |
| Short-term borrowings | 5 | 105 000 | 105 000 |
| Trade payables | 17 503 | 7 084 | |
| Other current liabilities | 1 594 | 1 566 | |
| Accrued expenses and prepaid income | 2 | 21 488 | 19 569 |
| Total Current liabilities | 185 584 | 133 219 | |
| Total Liabilities | 186 476 | 134 110 | |
| TOTAL EQUITY AND LIABILITIES | 468 383 | 453 263 |
Contingent liabilities and Pledged assets are presented in note 6.
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 | - | - | -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 | - | - | -105 112 | -105 112 |
| New share issue | 380 | 71 820 | - | 72 200 |
| Issue expenses | - | -4 335 | - | -4 335 |
| Closing balance as of April 30, 2014 | 8 557 | 640 924 | -367 574 | 281 907 |
Consolidated Cash flow statement
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Operating activities | |||||
| Operating income before financial items | -35 239 | -21 920 | -98 091 | -67 583 | |
| Depreciation/amortization | 1 184 | 1 265 | 4 941 | 5 089 | |
| Disposals of tangible and intangible assets | 0 | 86 | 3 | 86 | |
| Adjustments for income from divestiture of intangible assets | - | - | - | -1 579 | |
| Interest received | 41 | 274 | 192 | 587 | |
| Interest paid | -549 | -28 | -617 | -611 | |
| Cash flow from operating activities before working capital changes | -34 564 | -20 322 | -93 571 | -64 010 | |
| Change in working capital | |||||
| Change in inventories | 0 | - | -769 | -597 | |
| Change in trade receivables | 10 | - | -49 | - | |
| Change in other current receivables | 1 720 | -1 618 | 1 721 | -2 142 | |
| Change in trade payables | 10 294 | 2 652 | 10 419 | -3 197 | |
| Change in other current liabilities | 2 | -3 941 | -1 230 | -4 650 | -1 999 |
| Cash flow from operating activities | -26 481 | -20 518 | -86 899 | -71 946 | |
| Investing activities | |||||
| Investments in intangible fixed assets | 2 | -9 633 | -8 748 | -33 545 | -57 196 |
| Divestiture of intangible fixed assets | - | - | - | 4 235 | |
| Investments in property, plant and equipment | -1 878 | -80 | -2 138 | -4 428 | |
| Cash flow from investing activities | -11 511 | -8 828 | -35 682 | -57 388 | |
| Financing activities | |||||
| Increase in liabilities to credit institutions | 40 000 | - | 80 000 | - | |
| Decrease in liabilities to credit institutions | -40 000 | - | -40 000 | -3 197 | |
| New share issue | 72 200 | - | 72 200 | 122 658 | |
| Issue expenses | -4 335 | -37 | -4 335 | -4 598 | |
| New loans | - | - | - | 80 000 | |
| Repayment of loans | - | - | - | -4 600 | |
| Cash flow from financing activities | 67 865 | -37 | 107 865 | 190 263 | |
| Cash flow for the period | 29 873 | -29 382 | -14 716 | 60 928 | |
| Cash and cash equivalents at the beginning of the period | 18 368 | 92 338 | 62 956 | 2 028 | |
| Cash and cash equivalents at the end of the period | 48 241 | 62 956 | 48 241 | 62 956 |
Parent Company Income statement
| 2014 | 2013 | 2013/14 | 2012/13 | ||
|---|---|---|---|---|---|
| TSEK | Note | Feb-April | Feb-April | May-April | May-April |
| Net sales | 20 | - | 60 | - | |
| Capitalized development cost | 2 | 8 367 | 8 748 | 29 464 | 46 229 |
| Other operating income | 34 | 34 | 4 454 | 2 524 | |
| Raw materials, consumables and goods for resale | -3 120 | -1 260 | -6 835 | -6 137 | |
| Other external expenses | 2 | -28 001 | -16 686 | -75 129 | -62 509 |
| Employee benefit expenses | -11 343 | -11 389 | -45 101 | -42 408 | |
| Depreciation/amortization and impairment of | |||||
| property, plant, equipment and intangible assets | -1 184 | -1 261 | -4 938 | -5 074 | |
| Other operating expenses | 0 | -86 | 0 | -86 | |
| Operating income | -35 226 | -21 902 | -98 025 | -67 461 | |
| Result from participations in Group companies | 5 | -50 | -30 | -80 | -145 |
| Other interest revenues and similar revenues | 41 | 274 | 192 | 587 | |
| Interest cost and similar costs | -2 592 | -1 308 | -7 213 | -5 384 | |
| Financial items, net | -2 601 | -1 064 | -7 101 | -4 942 | |
| Income after financial items | -37 826 | -22 966 | -105 126 | -72 404 | |
| Taxes | 3 | - | - | - | - |
| Income for the period | -37 826 | -22 966 | -105 126 | -72 404 | |
Parent Company Balance Sheet
| TSEK | Note | 2014-04-30 | 2013-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible fixed assets | |||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
2,4 | 376 376 | 346 911 |
| similar rights Property, plant and equipment |
13 328 | 10 288 | |
| Equipment, tools, fixtures and fittings Construction in progress and advance payments |
22 988 | 20 355 | |
| for property, plant and equipment Financial assets |
1 413 | 5 805 | |
| Participations in group companies | 110 | 110 | |
| Other securities held as non-current assets | 1 | 1 | |
| Total Non-current assets | 414 215 | 383 471 | |
| Current assets | |||
| Inventories | |||
| Raw materials and consumables | 1 656 | 887 | |
| Current receivables | 1 656 | 887 | |
| Trade receivables | 49 | - | |
| Other current receivables | 2 727 | 2 312 | |
| Prepaid expenses and accrued income | 1 592 | 3 721 | |
| 4 368 | 6 033 | ||
| Cash and bank balances | 48 238 | 62 947 | |
| Total current assets | 54 263 | 69 867 | |
| TOTAL ASSETS | 468 478 | 453 339 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 8 557 | 8 177 | |
| Statutory reserve | 4 620 | 4 620 | |
| 13 177 | 12 797 | ||
| Non-restricted equity | |||
| Share premium reserve | 640 924 | 573 439 | |
| Retained earnings | -267 255 | -194 851 | |
| Income for the period | -105 126 | -72 404 | |
| 268 544 | 306 184 | ||
| Total equity | 281 721 | 318 981 | |
| Non-current liabilities | |||
| Other non-current liabilities | 891 | 891 | |
| Total non-current liabilities | 891 | 891 | |
| Current liabilities | |||
| Short term borrowings | 5 | 105 000 | 105 000 |
| Trade payables | 17 500 | 7 084 | |
| Liabilities to Credit institutions | 40 000 | - | |
| Liabilities to group companies | 285 | 247 | |
| Other current liabilities | 1 594 | 1 566 | |
| Accrued expenses and prepaid income | 2 | 21 488 | 19 569 |
| Total Current liabilities | 185 866 | 133 466 | |
| TOTAL EQUITY AND LIABILITIES | 468 478 | 453 339 | |
| Contingent liabilities and pledged assets | |||
| Contingent liabilities | 6 | - | - |
| Pledged assets | 6 | 8 000 | 8 000 |
Parent Company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| Statutory | Non-restricted | |||
| TSEK | Share capital | reserve | equity | Total equity |
| Opening balance as of May 1, 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 |
| New share issue | 380 | - | 71 820 | 72 200 |
| Issue expenses | - | - | -4 335 | -4 335 |
| Income for the period | - | - | -105 126 | -105 126 |
| Closing balance as of April 30, 2014 | 8 557 | 4 620 | 268 544 | 281 721 |
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.
Not 2 Restatements
Oasmia has in the last quarter improved the method for the determination of accrued costs for clinical trials when preparing the financial statement. This has led to restatements of historical figures of the costs for clinical trials which have been capitalized. The changes have no effect on the company net income or equity. The effects of the restatements are disclosed below.
| 2013 | 2013 | 2012/13 | 2012/13 | |||
|---|---|---|---|---|---|---|
| TSEK | Feb-April | Feb-April | May-April | May-April | ||
| According to | According to the | According to | According to the | |||
| previous reporting | Restatements | Income Statement | previous reporting | Restatements | Income Statement | |
| Capitalized development cost | 10 826 | -2 078 | 8 748 | 48 635 | -2 407 | 46 229 |
| Other external expenses | -18 778 | 2 078 | -16 700 | -65 022 | 2 407 | -62 616 |
Consolidated statement of financial position
| TSEK | 2013-04-30 | 2013-04-30 | 2012-05-01 | 2012-05-01 | ||
|---|---|---|---|---|---|---|
| According to the | According to the | |||||
| According to | Statement of | According to | Statement of | |||
| previous reporting | Restatements | financial position | previous reporting | Restatements | financial position | |
| Assets | ||||||
| Non-current assets | ||||||
| Capitalized development cost | 338 826 | 8 085 | 346 911 | 290 191 | 10 492 | 300 683 |
| Total non-current assets | 375 283 | 8 085 | 383 368 | 343 581 | 10 492 | 354 073 |
| Total assets | 445 178 | 8 085 | 453 263 | 349 807 | 10 492 | 360 299 |
| Current liabilities | ||||||
| Accrued expenses and prepaid income | 11 484 | 8 085 | 19 569 | 6 180 | 10 492 | 16 671 |
| Total current liabilities | 125 134 | 8 085 | 133 219 | 60 069 | 10 492 | 70 561 |
| Total liabilities | 126 025 | 8 085 | 134 110 | 76 334 | 10 492 | 86 825 |
| Total equity and liabilities | 445 178 | 8 085 | 453 263 | 349 807 | 10 492 | 360 299 |
| Consolidated Cash flow statement | ||||||
| 2013 | 2013 | 2012/13 | 2012/13 | |||
| TSEK | Feb-April | Feb-April | May-April | May-April | ||
| According to | According to the | According to | According to the | |||
| previous reporting | Restatements | Cash flow statement | previous reporting | Restatements | Cash flow statement |
| Change in working capital | ||||||
|---|---|---|---|---|---|---|
| Change in other current liabilities | 849 | -2 078 | -1 230 | 408 | -2 407 | -1 999 |
| Cash flow from operating activities | -18 439 | -2 078 | -20 518 | -69 539 | -2 407 | -71 946 |
| Investing activities | ||||||
| Investments in intangible fixed assets | -10 826 | 2 078 | -8 748 | -59 603 | 2 407 | -57 196 |
| Cash flow from investing activities | -10 906 | 2 078 | -8 828 | -59 795 | 2 407 | -57 388 |
| Parent company income statement |
| 2013 | 2013 | 2012/13 | 2012/13 | |||
|---|---|---|---|---|---|---|
| TSEK | Feb-April | Feb-April | May-April | May-April | ||
| According to | According to the | According to | According to the | |||
| previous reporting | Restatements | Income statement | previous reporting | Restatements | Income statement | |
| Capitalized development cost | 10 826 | -2 078 | 8 748 | 48 635 | -2 407 | 46 229 |
| Other external expenses | -18 765 | 2 078 | -16 686 | -64 916 | 2 407 | -62 509 |
Parent company balance sheet
| TSEK | 2013-04-30 | 2013-04-30 | 2012-05-01 | 2012-05-01 | ||
|---|---|---|---|---|---|---|
| According to | According to the | According to | According to the | |||
| previous reporting | Restatements | Balance sheet | previous reporting | Restatements | Balance sheet | |
| Assets | ||||||
| Non-current assets | ||||||
| Capitalized development cost | 338 826 | 8 085 | 346 911 | 290 191 | 10 492 | 300 683 |
| Total non-current assets | 375 386 | 8 085 | 383 471 | 343 668 | 10 492 | 354 160 |
| Total assets | 445 253 | 8 085 | 453 339 | 349 863 | 10 492 | 360 355 |
| Current liabilities | ||||||
| Accrued expenses and prepaid income | 11 484 | 8 085 | 19 569 | 6 180 | 10 492 | 16 671 |
| Total current liabilities | 125 381 | 8 085 | 133 466 | 60 274 | 10 492 | 70 766 |
| Total equity and liabilities | 445 253 | 8 085 | 453 339 | 349 863 | 10 492 | 360 355 |
Not 3 Taxes
The Group has accumulated losses carried forward amounting to TSEK 404 260 (300 546) and the Parent Company has similar amounting to TSEK 395 061 (290 988). 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 4 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 | 2014-04-30 | 2013-04-30 |
|---|---|---|
| Paclical | 280 919 | 261 242 |
| Paccal Vet-CA1 | 95 457 | 85 669 |
| Total | 376 376 | 346 911 |
Note 5 Transactions with related parties
No significant transactions with related parties have been performed in the fiscal year, other than remunerations to employees..
As of April 30, 2014 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 April 30, 2014, this credit was completely unutilized (also as of April 30, 2013).
On April 30, 2014, Oasmia carried a loan from its second largest owner Nexttobe AB amounting to TSEK 105,000 (105 000). In November 2013 the loan was extended with one year and it is now due on December 31, 2014. In 2014, the loan carries an interest of 8.5 % which previously was 5 % interest. The interest will be paid when the loan is due. As of April 30, 2014 the accrued interest cost for the loan amounted to TSEK 11 511 (5 053).
Oasmia has in the fiscal year made a TSEK 80 (145) group contribution to the subsidiary Qdoxx Pharma AB, where TSEK 50 (30) was provided in the fourth quarter. Impairment of shares in Qdoxx amounting to TSEK 80 (145) 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 6 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 7 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 Pharmaceuti cal AB ensures that this Year -end 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, June 5,2014
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 June 5, 2014 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.
Dividends
The Board of Directors does not intend to propose any dividends for the fiscal year May 1, 2013 ' April 30, 2014.
Annual Report
The Annual Repor t will be published on August 21, 2013 and will be available on the company website www.oasmia.com. The Annual Report may also be requested from Oasmia Pharmaceutical AB by phone +46 18 50 54 40 or by e-mail [email protected]
Annual General Meeting
The Annual General Meeting will be held on September 29, 2014 in the company offices in Uppsala. A notice for the Meeting is distributed four weeks before the Meeting at the latest. For more information, see the company website www.oasmia.com
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
| 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 |
| Interim report May 2014 – January 2015 | 2015-03-05 |
| Year-end report May 2014 – April 2015 | 2015-06-04 |