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Vivesto — Interim / Quarterly Report 2014
Dec 4, 2014
3124_ir_2014-12-04_72c1512c-3f4e-4404-a848-16a212a2d1ae.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for the period May – October 2014
POSITIVE RISK/BENEFIT PROFILE IN PACLICAL STUDY
SECOND QUARTER August 1 – October 31, 2014
- Consolidated Net sales amounted to TSEK 558 (24) 1
- Operating income amounted to TSEK -24,145 (-17,374)
- Net income after tax amounted to TSEK -26,715 (-18,661)
- Earnings per share amounted to SEK -0.30 (-0.23)
- Comprehensive income amounted to TSEK -26,715 (-18,661)
THE PERIOD May 1 – October 31, 2014
- Consolidated Net sales amounted to TSEK 1,552 (24)
- Operating income amounted to TSEK -54,496 (-34,359)
- Net income after tax amounted to TSEK -59,704 (-36,885)
- Earnings per share amounted to SEK -0.69 (-0.45)
- Comprehensive income amounted to TSEK -59,704 (-36,885)
- The full report from the clinical trial with Oasmia's product Paclical for treatment of ovarian cancer shows that Paclical has a positive risk/benefit profile compared to standard treatment.
- Anders Blom was appointed Executive Vice President in Oasmia, succeeding Hans Sundin who was elected as a new member of the Board.
EVENTS AFTER THE CLOSING DAY
- On November 11, Oasmia announced a fully committed and underwritten rights issue of approximately SEK 176 million.
- On November 17, Oasmia published the prospectus for the rights issue.
1 The numbers in parentheses show the results from the corresponding period of the previous year
CEO COMMENTS:
"Oasmia has had a very successful year so far, and we have achieved a number of important milestones, including the launch in the US of our first veterinary product Paccal Vet-CA1® . This quarter, we were able to announce the full results from our pivotal Phase III clinical study of Paclical, for the treatment of ovarian cancer. The results showed, among other things, that Paclical has a positive risk/benefit profile compared to the standard treatment, and that the benefits exceed the risks. The results will provide a basis for a Marketing Authorisation Application in Europe to the European Medicines Agency (EMA) in 2015.", commented Julian Aleksov, CEO and President 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 Stockholm and at the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
In July 2014, Paccal Vet CA-1 was launched on the US market. The product is manufactured at Oasmia's facility in Uppsala and delivered to Oasmias partner Abbott Animal Health. Oasmia's revenues from the product consist of an invoiced price per vial upon delivery and a royalty calculated on Abbott's net sales of the product. Altogether, these revenues amounted to TSEK 542 (-) in the second quarter and TSEK 1,524 (-) during the period.
PRODUCT DEVELOPMENT
HUMAN HEALTH
Paclical
Paclical is a patented formulation of paclitaxel in combination with Oasmia's patented technology XR-17. Paclical has received orphan drug designation (see below) in the EU and the US 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 cases globally. The total number of patients in the study was 789, and all patients have been followed up regarding progression free survival. In June 2014, Oasmia announced that the primary endpoint for the study had been met. The endpoint was to demonstrate that Paclical and Taxol, both in combination with carboplatin, have the same progression free survival. In October 2014, the company announced the results from the study which shows that Paclical has a positive risk/benefit profile compared to standard treatment. A final report for the clinical study is estimated to be completed in the fourth quarter of 2014. This data will constitute the foundation for a submission of a Marketing Authorization Application to the EMA in 2015.
In September 2012, Oasmia submitted an application for market authorization for Paclical in Russia, which is currently being processed by the Russian pharmaceutical authorities. Oasmia expects a notice in the first calendar quarter of 2015.
Doxophos
Doxophos is a patented formulation of the cytostatic doxorubicin in combination with XR-17 for treatment of breast cancer. 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 for treatment of breast cancer. 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 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. Pre-clinical studies performed in 2013 have shown promising results. The company still intends to start validation of the production of OAS-19 during the current fiscal year.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE! | PHASE II | PHASE III | REG./ | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paclical (paclitaxel) |
Ovarian cancer | Ongoing | Global Tex-RUS/CIS) |
oasmia | ||||
| Ovarian cancer | In Registration | RUS/CIS | IPHARMASYNTEZ | |||||
| Metastatic breast cancer |
Ongoing | Global | oasmia | |||||
| Doxophos doxorubicin) |
Breast cancer | Planning | 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
Paccal Vet®
Paccal Vet is a patented formulation of paclitaxel in combination with XR-17. In July 2014, Paccal Vet-CA1 was launched in the US by Oasmia's American partner Abbott Animal Health as the first injectable chemotherapeutic product for treatment of solid tumours in dogs.
Oasmia has been granted MUMS designation (see below) by the American Food and Drug Administration (FDA) for Paccal Vet in treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma.
In February 2014, Oasmia was granted conditional approval in the US by the FDA of Paccal Vet-CA1 for treatment of mammary carcinoma and squamous cell carcinoma in dogs. In order to apply for a full approval for these indications, Oasmia is planning a Phase III study for each indication.
The company is conducting a complementary study on Paccal Vet for the treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs that have been treated four times with three-week intervals. All 50 dogs were treated in the quarter that ended in April 2014. If the result is in in line with the expectations, Oasmia intends to submit an application for market approval to the European Medicines Agency (EMA) in the first half of 2015. Oasmia will also consider submitting an application of market approval to the FDA.
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 upcoming clinical program and 12 dogs have been treated in May 2014. Oasmia aims to finalize a study report in the first half of 2015, which is a delay from the previous estimation autumn 2014. The cause for the delay is that it has taken somewhat longer time to collect data from the study.
| CANDIDATE | PRE-CLINICAL INDICATION |
PHASE! | PHASE II | PHASE III | REG./ | RIGHTS | ||
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paccal Vet e - CA1 (pacitaxel) |
Mammary/ squamous cell |
Planned for full approval |
Conditionally approved |
Global (ex-RUS/JAP) |
Abbott ÷ Arimal Health |
|||
| candidate and control of the state | Mast cell | Ongoing | Global (ex-BLIS/IAP) |
Abbott − |
||||
| Doxophos Vet doxorubicin) |
52.BHF Lymphoma 부장과 보고 오려 있다 |
Ongoing | Planned | Global 1009 PG |
Abbott - Animal Health |
MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
Annual General Meeting 2014
In September, the Annual General Meeting made a resolution that the Board shall consist of six regular members without deputies. The Annual General Meeting re-elected the Board members Joel Citron, Horst Domdey, Alexander Kotsinas, Bo Cederstrand, and Julian Aleksov. The meeting also elected Hans Sundin as a new regular Member of the Board until the next Annual General Meeting. Joel Citron was elected as Chairman of the Board.
Oasmia considers secondary listing on NASDAQ USA
Oasmia consider a secondary listing of ADR's (American Depositary Receipts) on the United States NASDAQ stock market. The company has initiated the application process, as well as filed a registration statement with the United States Securities and Exchange Commission under the JOBS Act. The company's shares are currently listed on NASDAQ Stockholm and the Frankfurt Stock Exchange.
Oasmia receives a new MSEK 40 bank loan
Oasmia has received a new MSEK 40 bank loan, with a term from October 1 to December 30, 2014. The loan replaced a previous bank loan which was due on September 30, 2014.
Anders Blom appointed Executive Vice President
Anders Blom was appointed Executive Vice President, succeeding Hans Sundin. Anders Blom will continue as CEO of Nexttobe AB.
Share price development during the period (SEK)
EVENTS AFTER CLOSING DAY
Oasmia announced a fully committed and underwritten rights issue of approximately SEK 176 million on November 11.
The rights issue is fully committed and underwritten by a combination of subscription and guarantee commitments. Certain larger shareholders, including Alceco International S.A. and Nexttobe AB, have undertaken to subscribe for their pro rata shares in the rights issue. Additionally, certain larger shareholders, including Alceco International S.A., have committed to subscribe and pay for any remaining part of the rights issue not subscribed for through subscription with or without preferential rights. The subscription price is SEK 18.0 per new share.
Oasmia published a prospectus, containing new financial information, for the company's preferential rights issue on November 17.
The Board of Directors in Oasmia has prepared a prospectus regarding the preferential rights issue that was announced on November 11, 2014. The prospectus has been approved and registered by the Swedish Finance Inspection Agency (FI). The company has published liabilities, equity, and net debt in the prospectus as of September 30, 2014.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2014 | 2013 | 2014 | 2013 | 2013/14 | |
|---|---|---|---|---|---|
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 558 | 24 | 1,552 | 24 | 60 |
| Capitalized development cost | 5,427 | 8,198 | 9,928 | 15,484 | 29,464 |
| Other operating income | 61 | 53 | 153 | 4,353 | 4,454 |
| Operating expenses | -30,192 | -25,649 | -66,129 | -54,219 | -132,069 |
| Operating income | -24,145 | -17,374 | -54,496 | -34,359 | -98,091 |
| Net income after tax | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 |
| Earnings per share (SEK), before and after dilution | -0.30 | -0.23 | -0.69 | -0.45 | -1.28 |
| Comprehensive income for the period | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 |
SECOND QUARTER
August 1 – October 31, 2014
Net sales
Net sales amounted to TSEK 558 (24) and consisted almost entirely of Paccal Vet-CA1 sales revenue.
Capitalized development cost
Capitalized development costs, which refers to Phase III clinical trials for the product candidates Paclical and Paccal Vet, amounted to TSEK 5,427 (8,198). Of the capitalization, Paclical comprised TSEK 2,403 (5,956) and Paccal Vet comprised TSEK 3,025 (2,242).
Other operating income
Other operating income amounted to TSEK 61 (53).
Operating expenses
Operating expenses including depreciation, amortization and impairments was significantly higher compared to the corresponding quarter previous year and amounted to TSEK 30,192 (25,649). The increased operating expenses were mainly attributable to method development in the production at Oasmia and its contract manufacturers, increased administration expenses and consumable equipment costs.
The number of employees at the end of the quarter was 75 (79).
Net income for the quarter
Net income after tax amounted to TSEK -26,715 (-18,661). The decrease in net income between these two quarters was attributable to significantly increased operating expenses, increased interest expenses and a decreased capitalization of development costs.
The Group's operations have not been impacted by seasonal variations or cyclical effects.
THE PERIOD May 1 – October 31, 2014
Net sales
Net sales amounted to TSEK 1,552 (24) and consisted mainly of Paccal Vet-CA1 sales revenue.
Capitalized development cost
Capitalized development costs, which concerns Phase III clinical trials for the product candidates Paclical and Paccal Vet, amounted to TSEK 9,928 (15,484). Of the capitalization, Paclical comprised TSEK 5,362 (10,412) and Paccal Vet comprised TSEK 4,566 (5,072).
Other operating income
Other operating income amounted to TSEK 153 (4,353). During the corresponding period previous year, an insurance compensation amounting to TSEK 4,250 was received.
Operating expenses
Operating expenses including depreciation, amortization and impairments was significantly higher compared to the corresponding period previous year and amounted to TSEK 66,129 (54,219). The costs for clinical trials have decreased somewhat, but costs related to the commercial phase Oasmia has entered have increased significantly more. The latter costs refer to, among other things, method development in production at Oasmia and its contract manufacturers, increased purchases of raw materials and supplies for production as well as increased personnel and administration expenses.
The number of employees at the end of the period was 75 (79).
Net Income for the period
Net income after tax was TSEK -59,704 (-36,885). The decrease in net income compared to the corresponding period previous year was attributable to significantly increased operating expenses, a decreased capitalization of development costs, decreased other operating income and increased interest expenses for loans.
The Group's operations have not been impacted by seasonal variations or cyclical effects.
Cash flow and Capital expenditures
Cash flow from operating activities amounted to TSEK -55,695 (-34,157). The decrease compared to the corresponding period previous year is attributable to a significant decrease in operating income.
Cash flow from investing activities amounted to TSEK -12,243 (-17,949). Of these, investments in intangible assets amounted to TSEK 10,230 (17,887), consisting of capitalized development costs TSEK 9,928 (15,484) and of patents TSEK 301 (2,403). Of these, TSEK 2,014 (62) was investments in property, plant and equipment, mainly production equipment.
Financing
During the period May – October 2014, financing was covered by liquid assets provided to the company in the directed share issues which were completed in March 2014 and July 2014 respectively. In the period Oasmia received a MSEK 40 bank loan, with a term from October 1 – December 30, 2014. The loan replaced a previous bank loan which was due on September 30, 2014.
Financial position
The consolidated liquid assets at the end of the period amounted to TSEK 27,135 (10,851). The interest-bearing liabilities were TSEK 145,000 (105,000).
At the end of the period, 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 period was TSEK 269,035 (282,268), the equity/assets ratio was 59 % (68 %), and the net debt/equity ratio was 44 % (33 %).
The parent company
The parent company´s net sales amounted to TSEK 1,552 (24) and net income before tax amounted to TSEK -59,695 (-36,887). The parent company's liquid assets at the end of the period amounted to TSEK 27,132 (10,842).
Future financing
Oasmia has one product approved in one country, but this does not create a sufficient cash flow from its own business. For this reason, Oasmia continuously work with various financing alternatives. Available consolidated cash and cash equivalents as well and unutilized credit facilities, as of October 31, are not sufficient to fund the planned activities during the next 12 months. In light of available financing alternatives and the recent developments in the company, the Board of Directors assesses that the prospects are good for the financing of the Company´s operations in the coming year.
Key ratios and other information
| 2014 | 2013 | 2014 | 2013 | 2013/14 | |
|---|---|---|---|---|---|
| Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution Weighted average number of shares (in thousands) before and after |
88,072 | 81,772 | 88,072 | 81,772 | 85,572 |
| dilution | 88,072 | 81,772 | 87,135 | 81,772 | 82,272 |
| Earnings per share in SEK, before and after dilution | -0.30 | -0.23 | -0.69 | -0.45 | -1.28 |
| Equity per share, SEK | 3.05 | 3.45 | 3.05 | 3.45 | 3.29 |
| Equity/Assets ratio, % | 59 | 68 | 59 | 68 | 60 |
| Net debt, TSEK | 117,865 | 94,149 | 117,865 | 94,149 | 96,759 |
| Net debt/Equity ratio, % | 44 | 33 | 44 | 33 | 34 |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 75 | 79 | 75 | 79 | 78 |
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 assets.
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 | 2014 | 2013 | 2013/14 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 558 | 24 | 1,552 | 24 | 60 | |
| Capitalized development cost | 2 | 5,427 | 8,198 | 9,928 | 15,484 | 29,464 |
| Other operating income | 61 | 53 | 153 | 4,353 | 4,454 | |
| Raw materials, consumables and goods for resale | -1,318 | -1,203 | -5,567 | -2,286 | -6,835 | |
| Other external expenses | 2 | -17,582 | -13,183 | -34,767 | -27,627 | -75,189 |
| Employee benefit expenses | -10,162 | -10,030 | -23,335 | -21,827 | -45,101 | |
| Depreciation, amortization and impairment | -1,129 | -1,233 | -2,461 | -2,479 | -4,941 | |
| Other operating expenses | - | - | - | - | -3 | |
| Operating income | -24,145 | -17,374 | -54,496 | -34,359 | -98,091 | |
| Financial income | 8 | 55 | 16 | 140 | 192 | |
| Financial expenses | -2,577 | -1,342 | -5,224 | -2,666 | -7,213 | |
| Financial items, net | -2,569 | -1,287 | -5,208 | -2,526 | -7,021 | |
| Income before taxes | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 | |
| Taxes | 3 | - | - | - | - | - |
| Income for the period | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 | |
| Income for the period attributable to: | ||||||
| Shareholders of the Parent company | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 | |
| Earnings per share before and after dilution, SEK | -0.30 | -0.23 | -0.69 | -0.45 | -1.28 |
Consolidated Statement of Comprehensive income
| TSEK | Note | 2014 Aug-Oct |
2013 Aug-Oct |
2014 May-Oct |
2013 May-Oct |
2013/14 May-April |
|---|---|---|---|---|---|---|
| Income for the period | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 | |
| Comprehensive income for the period | -26,715 | -18,661 | -59,704 | -36,885 | -105,112 | |
| Comprehensive income for the period attributable to: Shareholders of the Parent company |
-26,715 | -18,661 | -59,704 | -36,885 | -105,112 | |
| Comprehensive Earnings per share before and after dilution, SEK | -0.30 | -0.23 | -0.69 | -0.45 | -1.28 |
Consolidated statement of financial position
| TSEK | Note | 2014-10-31 | 2013-10-31 | 2014-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 24,282 | 24,243 | 24,401 | |
| Capitalized development cost | 2,4 | 386,304 | 362,395 | 376,376 |
| Other intangible assets | 12,101 | 12,198 | 13,328 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 422,689 | 398,838 | 414,106 | |
| Current assets | ||||
| Inventories | 2,768 | 1,853 | 1,656 | |
| Trade receivables | 550 | 30 | 49 | |
| Other current receivables | 3,732 | 2,726 | 2,729 | |
| Accrued expenses and prepaid income | 1,550 | 2,792 | 1,601 | |
| Liquid assets | 27,135 | 10,851 | 48,241 | |
| Total Current assets | 35,735 | 18,252 | 54,276 | |
| TOTAL ASSETS | 458,424 | 417,090 | 468,383 | |
| EQUITY | ||||
| Capital and provisions attributable to shareholders of the Parent Company | ||||
| Share capital | 8,807 | 8,177 | 8,557 | |
| Other capital provided | 687,506 | 573,439 | 640,924 | |
| Retained earnings | -427,278 | -299,348 | -367,574 | |
| Total Equity | 269,035 | 282,268 | 281,907 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 891 | 891 | 891 | |
| Total Non-current liabilities | 891 | 891 | 891 | |
| Current liabilities | ||||
| Liabilities to credit institutions | 40,000 | - | 40,000 | |
| Short-term borrowings | 5 | 105,000 | 105,000 | 105,000 |
| Trade payables | 16,367 | 4,052 | 17,503 | |
| Other current liabilities | 1,645 | 1,692 | 1,594 | |
| Accrued expenses and prepaid income | 2,5 | 25,486 | 23,187 | 21,488 |
| Total Current liabilities | 188,498 | 133,931 | 185,584 | |
| Total Liabilities | 189,389 | 134,822 | 186,476 | |
| TOTAL EQUITY AND LIABILITIES | 458,424 | 417,090 | 468,383 |
Contingent liabilities and Pledged assets are presented in note 6
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | ||||
|---|---|---|---|---|
| Other | ||||
| TSEK | Share capital | capital provided | Retained earnings | Total equity |
| Opening balance as of May 1, 2013 | 8,177 | 573,439 | -262,463 | 319,153 |
| Comprehensive income for the period | - | - | -36,885 | -36,885 |
| Closing balance as of October 31, 2013 | 8,177 | 573,439 | -299,348 | 282,268 |
| 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 |
| Opening balance as of May 1, 2014 | 8,557 | 640,924 | -367,574 | 281,907 |
| Comprehensive income for the period | - | - | -59,704 | -59,704 |
| New share issue | 250 | 49,750 | - | 50,000 |
| Issue expenses | - | -3,168 | - | -3,168 |
| Closing balance as of October 31, 2014 | 8,807 | 687,506 | -427,278 | 269,035 |
Consolidated Cash flow statement
| 2014 | 2013 | 2014 | 2013 | 2013/14 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Operating activities | ||||||
| Operating income before financial items | -24,145 | -17,374 | -54,496 | -34,359 | -98,091 | |
| Depreciation, amortization | 1,129 | 1,233 | 2,461 | 2,479 | 4,941 | |
| Disposals of tangible and intangible assets | - | - | - | - | 3 | |
| Interest received | 8 | 55 | 16 | 140 | 192 | |
| Interest paid | -479 | -19 | -612 | -20 | -617 | |
| Cash flow from operating activities before | ||||||
| working capital changes | -23,488 | -16,105 | -52,631 | -31,759 | -93,571 | |
| Change in working capital | ||||||
| Change in inventories | -51 | -966 | -1,111 | -966 | -769 | |
| Change in trade receivables | 487 | -30 | -501 | -30 | -49 | |
| Change in other current receivables | 387 | -1,182 | 247 | 533 | 1,721 | |
| Change in trade payables | -758 | 228 | -1,136 | -3,033 | 10,419 | |
| Change in other current liabilities | 2 | -1,213 | -402 | -562 | 1,098 | -4,650 |
| Cash flow from operating activities | -24,637 | -18,457 | -55,695 | -34,157 | -86,899 | |
| Investing activities | ||||||
| Investments in intangible assets | 2 | -5,729 | -9,487 | -10,230 | -17,887 | -33,545 |
| Investments in property, plant and equipment | -587 | -34 | -2,014 | -62 | -2,138 | |
| Cash flow from investing activities | -6,316 | -9,521 | -12,243 | -17,949 | -35,682 | |
| Financing activities | ||||||
| Increase in liabilities to credit institutions Decrease in liabilities to credit institutions |
- - |
- - |
- - |
- - |
80,000 -40,000 |
|
| New share issue | - | - | 50,000 | - | 72,200 | |
| Issue expenses | - | - | -3,168 | - | -4,335 | |
| Cash flow from financing activities | 0 | 0 | 46,832 | 0 | 107,865 | |
| Cash flow for the period | -30,954 | -27,978 | -21,106 | -52,106 | -14,716 | |
| Cash and cash equivalents at the beginning of the period | 58,088 | 38,829 | 48,241 | 62,956 | 62,956 | |
| Cash and cash equivalents at the end of the period | 27,135 | 10,851 | 27,135 | 10,851 | 48,241 |
Parent Company Income statement
| 2014 | 2013 | 2014 | 2013 | 2013/14 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Net sales | 558 | 24 | 1,552 | 24 | 60 | |
| Capitalized development cost | 2 | 5,427 | 8,198 | 9,928 | 15,484 | 29,464 |
| Other operating income | 61 | 53 | 153 | 4,353 | 4,454 | |
| Raw materials, consumables and goods for resale | -1,318 | -1,203 | -5,567 | -2,286 | -6,835 | |
| Other external expenses | 2 | -17,578 | -13,173 | -34,758 | -27,601 | -75,129 |
| Employee benefit expenses | -10,162 | -10,030 | -23,335 | -21,827 | -45,101 | |
| Depreciation, amortization and impairment of property, plant, equipment and intangible assets |
-1,129 | -1,231 | -2,461 | -2,476 | -4,938 | |
| Other operating expenses | - | - | - | - | 0 | |
| Operating income | -24,140 | -17,362 | -54,487 | -34,330 | -98,025 | |
| Result from participations in Group companies | - | -30 | - | -30 | -80 | |
| Other interest revenues and similar revenues | 8 | 55 | 16 | 140 | 192 | |
| Interest cost and similar costs | -2,577 | -1,342 | -5,224 | -2,666 | -7,213 | |
| Financial items, net | -2,569 | -1,317 | -5,208 | -2,556 | -7,101 | |
| Income after financial items | -26,710 | -18,679 | -59,695 | -36,887 | -105,126 | |
| Taxes | 3 | - | - | - | - | - |
| Income for the period | -26,710 | -18,679 | -59,695 | -36,887 | -105,126 |
Parent Company Balance Sheet
| TSEK | Note | 2014-10-31 | 2013-10-31 | 2014-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
2,4 | 386,304 | 362,395 | 376,376 |
| similar rights | 12,101 | 12,194 | 13,328 | |
| Property, plant and equipment | ||||
| Equipment, tools, fixtures and fittings Construction in progress and advance payments |
22,684 | 18,417 | 22,988 | |
| for property, plant and equipment | 1,598 | 5,826 | 1,413 | |
| Financial assets | ||||
| Participations in group companies | 110 | 110 | 110 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 422,798 | 398,944 | 414,215 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 2,768 | 1,656 | 1,656 | |
| Advance payments to suppliers | - | 197 | - | |
| 2,768 | 1,853 | 1,656 | ||
| Current receivables | ||||
| Trade receivables | 550 | 30 | 49 | |
| Other current receivables | 3,731 | 2,724 | 2,727 | |
| Prepaid expenses and accrued income | 1,548 | 2,785 | 1,592 | |
| 5,829 | 5,540 | 4,368 | ||
| Cash and bank balances | 27,132 | 10,842 | 48,238 | |
| Total current assets | 35,729 | 18,235 | 54,263 | |
| TOTAL ASSETS | 458,527 | 417,179 | 468,478 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 8,807 | 8,177 | 8,557 | |
| Statutory reserve | 4,620 | 4,620 | 4,620 | |
| 13,427 | 12,797 | 13,177 | ||
| Non-restricted equity | ||||
| Share premium reserve | 687,506 | 573,439 | 640,924 | |
| Retained earnings | -372,380 | -267,255 | -267,255 | |
| Income for the period | -59,695 | -36,887 | -105,126 | |
| 255,431 | 269,297 | 268,544 | ||
| Total equity | 268,858 | 282,095 | 281,721 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 891 | 891 | 891 | |
| Total non-current liabilities | 891 | 891 | 891 | |
| Current liabilities | ||||
| Short term borrowings | 5 | 105,000 | 105,000 | 105,000 |
| Trade payables | 16,367 | 4,052 | 17,500 | |
| Liabilities to Credit institutions | 40,000 | - | 40,000 | |
| Liabilities to group companies | 280 | 262 | 285 | |
| Other current liabilities | 1,645 | 1,692 | 1,594 | |
| Accrued expenses and prepaid income | 2,5 | 25,486 | 23,187 | 21,488 |
| Total Current liabilities | 188,778 | 134,193 | 185,866 | |
| TOTAL EQUITY AND LIABILITIES | 458,527 | 417,179 | 468,478 | |
| Contingent liabilities and pledged assets | ||||
| Contingent liabilities | 6 | - | - | - |
| Pledged assets | 6 | 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, 2013 | 8,177 | 4,620 | 306,184 | 318,981 |
| Income for the period | - | - | -36,887 | -36,887 |
| Closing balance as of October 31, 2013 | 8,177 | 4,620 | 269,297 | 282,095 |
| 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 |
| Opening balance as of May 1, 2014 | 8,557 | 4,620 | 268,544 | 281,721 |
| New share issue | 250 | - | 49,750 | 50,000 |
| Issue expenses | - | - | -3,168 | -3,168 |
| Income for the period | - | - | -59,695 | -59,695 |
| Closing balance as of October 31, 2014 | 8,807 | 4,620 | 255,431 | 268,858 |
Note 1 Accounting policies
This report is established in accordance with IAS 34, Interim Financial Reporting and the Swedish 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 Swedish Annual Accounts Act. The Parent Company accounts are established in accordance with RFR 2, Accounting for legal entities and the Swedish 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 2013 – April 30 2014. The new and revised accounting policies applied by Oasmia since May 1, 2014, has 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, 2014. Similar to what was the case at the end of the previous fiscal year, carrying amounts are the same as fair values. The Group currently only has one operating segment and does therefore not disclose any segment information.
Note 2 Restatements
In the fiscal year 2013/14, Oasmia improved the method for the determination of accrued costs for clinical trials. This has led to restatements of historical figures of the costs for clinical trials which have been capitalized. The changes are called Restatements in accordance with IAS 8. The changes have no effect on the company net income or equity. The effects of the restatements are disclosed below.
Consolidated Income Statement
| 2013 | 2013 | 2013 | 2013 | |||
|---|---|---|---|---|---|---|
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | ||
| According to | According to | According to | According to | |||
| previous | the Income | Previous | the Income | |||
| reporting | Restatements | Statement | reporting | Restatements | Statement | |
| Capitalized development cost | 7,181 | 1,017 | 8,198 | 14,006 | 1,478 | 15,484 |
| Other external expenses | -12,166 | -1,017 | -13,183 | -26,148 | -1,478 | -27,627 |
Consolidated statement of financial position
| TSEK | 2013-10-31 | 2013-10-31 | |
|---|---|---|---|
| According to | According to the | ||
| previous | Statement of | ||
| reporting | Restatements | financial position | |
| Assets | |||
| Non-current assets | |||
| Capitalized development cost | 352,832 | 9,564 | 362,395 |
| Total non-current assets | 389,274 | 9,564 | 398,838 |
| Total assets | 407,526 | 9,564 | 417,090 |
| Current liabilities | |||
| Accrued expenses and prepaid income | 13,624 | 9,564 | 23,187 |
| Total current liabilities | 124,367 | 9,564 | 133,931 |
| Total liabilities | 125,258 | 9,564 | 134,822 |
| Total equity and liabilities | 407,526 | 9,564 | 417,090 |
Consolidated Cash flow statement
| 2013 | 2013 | 2013 | 2013 | |||
|---|---|---|---|---|---|---|
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | ||
| According to | According to the | According to | According to the | |||
| previous | Cash flow | previous | Cash flow | |||
| reporting | Restatements | statement | reporting | Restatements | statement | |
| Change in working capital | ||||||
| Change in other current liabilities | -1,419 | 1,017 | -402 | -380 | 1,478 | 1,098 |
| Cash flow from operating activities | -19,474 | 1,017 | -18,457 | -35,635 | 1,478 | -34,157 |
| Investing activities | ||||||
| Investments in intangible fixed assets | -8,470 | -1,017 | -9,487 | -16,408 | -1,478 | -17,887 |
| Cash flow from investing activities | -8,504 | -1,017 | -9,521 | -16,471 | -1,478 | -17,949 |
| Parent company income statement | ||||||
| 2013 | 2013 | 2013 | 2013 | |||
| TSEK | Aug-Oct | Aug-Oct | May-Oct | May-Oct | ||
| According to | According to | According to | According to | |||
| previous | the Income | previous | the Income | |||
| reporting | Restatements | statement | reporting | Restatements | statement | |
| Capitalized development cost | 7,181 | 1,017 | 8,198 | 14,006 | 1,478 | 15,484 |
| Other external expenses | -12,156 | -1,017 | -13,173 | -26,123 | -1,478 | -27,601 |
Parent company balance sheet
| TSEK | 2013-10-31 | 2013-10-31 | |
|---|---|---|---|
| According to | According | ||
| previous | to the | ||
| reporting | Restatements | Balance sheet | |
| Assets | |||
| Non-current assets | |||
| Capitalized development cost | 352,832 | 9,564 | 362,395 |
| Total non-current assets | 389,380 | 9,564 | 398,944 |
| Total assets | 407,615 | 9,564 | 417,179 |
| Current liabilities | |||
| Accrued expenses and prepaid income | 13,624 | 9,564 | 23,187 |
| Total current liabilities | 124,630 | 9,564 | 134,193 |
| Total equity and liabilities | 407,615 | 9,564 | 417,179 |
Note 3 Taxes
The Group has accumulated losses carried forward, related to previous years and the period, amounting to TSEK 463,864 (336,605) and the Parent Company has similar amounting to TSEK 454,656 (327,019). 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 for the product candidates Paclical and Paccal Vet. The capitalization means that such costs are capitalized as an intangible asset. Amortization is carried out on a straight-line basis over the period that the expected benefits are expected to generate earnings for the Company, which is from the date that commercial sale to final customers is commenced. This point in time occurs in most cases after receiving full approval for the indication (eg, a cancer-type) of a product candidate in a specific market. The accumulated assets per product candidate are disclosed below.
| TSEK | 2014-10-31 | 2013-10-31 | 2014-04-30 |
|---|---|---|---|
| Paclical | 286,281 | 271,654 | 280,919 |
| Paccal Vet | 100,023 | 90,741 | 95,457 |
| Total | 386,304 | 362,395 | 376,376 |
Note 5 Transactions with related parties
No significant transactions with related parties have been performed during the period, other than remunerations to employees.
As of October 31, 2014 Oasmia had a credit facility of TSEK 40,000 (40,000) provided by the principal shareholder of the company, Alceco International S.A. The interest rate on utilized credits is 5 %. As of October 31, 2014, this credit was completely unutilized (also as of October 31, 2013).
On October 31, 2014, Oasmia carried a loan from its second largest shareholder Nexttobe AB amounting to TSEK 105,000 (105,000). During 2014, the loan carries an 8.5 % interest, from a previous 5 % interest. The interest will be paid when the loan is due on December 31, 2014. As of October 31, 2014 the accrued interest cost for the loan amounted to TSEK 16,010 (7,699).
Note 6 Contingent liabilities and Pledged assets
The parent company has made a floating charge of TSEK 8,000 to a bank as security for a TSEK 5,000 bank overdraft and limit for a TSEK 3,000 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 2013 – April 30 2014. No additional risks beyond those described therein have been judged significant.
The Board of Directors and CEO of Oasmia Pharmaceutical AB ensures that this interim report gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group face.
Uppsala, December 3, 2014
| Joel Citron, Chairman | Bo Cederstrand, Member | Prof. Dr. Horst Domdey, Member | ||
|---|---|---|---|---|
| Alexander Kotsinas, Member | Hans Sundin, Member | Julian Aleksov, Member and CEO |
The information in this interim report is such that Oasmia Pharmaceutical (publ) must publish according to the Swedish Securities Markets Act. The information was delivered for publication on December 4, 2014 at 8.15.
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 IS A TRANSLATION FROM THE SWEDISH ORIGINAL
Review report
Oasmia Pharmaceutical AB, corporate identity number 556332-6676
Introduction
We have reviewed the condensed interim report for Oasmia Pharmaceutical AB as at October 31, 2014 and for the six months period then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
Scope of review
We conducted our review in accordance with the International Standard on Review Engagements, ISRE 2410 Review of Interim Financial Statements Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act regarding the Group, and in accordance with the Swedish Annual Accounts Act regarding the Parent Company.
Uppsala the 4th of December 2014
Ernst & Young AB
Björn Ohlsson Authorized Public Accountant
COMPANY INFORMATION Oasmia Pharmaceutical AB (publ) Corp. Reg. No: 556332-6676 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: Anders Lundin, CFO Tel: +46 70 209 63 00 E-post: [email protected]
UPCOMING REPORT DATES
| Interim report May 2014 – January 2015 | 2015-03-05 |
|---|---|
| Year-end report May 2014 – April 2015 | 2015-06-04 |
| Interim report May – July 2015 | 2015-09-03 |
| Interim report May – October 2015 | 2015-12-03 |
Key figures in EUR (additional information)
Key figures are translated into EUR as additional information as a service to shareholders in the euro zone. It is not the official report in the functional currency of Oasmia, which is SEK. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per October 31, 2014 which was 9.2364 SEK per one EUR (source: Swedish Central Bank).
| 2014 | 2013 | 2014 | 2013 | 2013/14 | |
|---|---|---|---|---|---|
| € thousand if nothing else is stated | Aug-Oct | Aug-Oct | May-Oct | May-Oct | May-April |
| Key ratios and other information | |||||
| Number of shares at the close of the period (in thousands), | |||||
| before and after dilution | 88,072 | 81,772 | 88,072 | 81,772 | 85,572 |
| Weighted average number of shares (in thousands), | |||||
| before and after dilution | 88,072 | 81,772 | 87,135 | 81,772 | 82,272 |
| Earnings per share in € , before and after dilution | -0.03 | -0.02 | -0.07 | -0.05 | -0.14 |
| Equity per share, € | 0.33 | 0.37 | 0.33 | 0.37 | 0.36 |
| Equity/Assets ratio, % | 59 | 68 | 59 | 68 | 60 |
| Net debt, € thousand | 12,761 | 10,193 | 12,761 | 10,193 | 10,476 |
| Net debt/Equity ratio, % | 44 | 33 | 44 | 33 | 34 |
| Number of employees at the end of the period | 75 | 79 | 75 | 79 | 78 |
| Consolidated income statement in brief | |||||
| Net sales | 60 | 3 | 168 | 3 | 6 |
| Capitalized development cost | 588 | 888 | 1,075 | 1,676 | 3,190 |
| Operating income | -2,614 | -1,881 | -5,900 | -3,720 | -10,620 |
| Financial items, net | -278 | -139 | -564 | -274 | -760 |
| Income before taxes | -2,892 | -2,020 | -6,464 | -3,993 | -11,380 |
| Income for the period | -2,892 | -2,020 | -6,464 | -3,993 | -11,380 |
| Consolidated statement of financial position in brief | |||||
| Total non-current assets | 45,763 | 43,181 | 45,763 | 43,181 | 44,834 |
| Total current assets | 3,869 | 1,976 | 3,869 | 1,976 | 5,876 |
| Total assets | 49,632 | 45,157 | 49,632 | 45,157 | 50,711 |
| Total equity | 29,128 | 30,560 | 29,128 | 30,560 | 30,521 |
| Total non-current liabilities | 96 | 96 | 96 | 96 | 96 |
| Total current liabilities | 20,408 | 14,500 | 20,408 | 14,500 | 20,093 |
| Total liabilities | 20,505 | 14,597 | 20,505 | 14,597 | 20,189 |
| Total equity and liabilities | 49,632 | 45,157 | 49,632 | 45,157 | 50,711 |
| Consolidated cash flow statement in brief | |||||
| Operating income before financial items | -2,614 | -1,881 | -5,900 | -3,720 | -10,620 |
| Cash flow from operating activities before working capital | |||||
| changes | -2,543 | -1,744 | -5,698 | -3,438 | -10,131 |
| Cash flow from operating activities | -2,667 | -1,998 | -6,030 | -3,698 | -9,408 |
| Cash flow from investing activities | -684 | -1,031 | -1,326 | -1,943 | -3,863 |
| Cash flow from financing activities | - | - | 5,070 | - | 11,678 |
| Cash flow for the period | -3,351 | -3,029 | -2,285 | -5,641 | -1,593 |
| Cash and cash equivalents at the end of the period | 2,938 | 1,175 | 2,938 | 1,175 | 5,223 |