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Vivesto — Interim / Quarterly Report 2015
Sep 3, 2015
3124_10-q_2015-09-03_441a1902-ab40-412a-a84a-b5fb3ca83577.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for the period May - July 2015
Oasmia has reclaimed the global distribution and sales rights for Paccal Vet and Doxophos Vet
FIRST QUARTER May 1 – July 31, 2015
- Consolidated Net sales amounted to TSEK 219 (994) 1
- Operating income was TSEK -37,819 (-30 351)
- Net income after tax amounted to TSEK -39,819 (-32 989)
- Earnings per share was SEK -0.41 (-0.38)
- Comprehensive income was TSEK -39,804 (-32 989)
- Oasmia filed a registration statement on listing at NASDAQ USA.
- Oasmia regained the global rights to Paccal Vet and Doxophos Vet and established a sales company in the USA.
EVENTS AFTER THE CLOSING DAY
Oasmia published positive results for Paclical in a head-to-head comparative study with Abraxane.
1 The numbers in parentheses show the results from the corresponding period of the previous year
CEO COMMENTS:
"We took a number of important steps for the future development of the company during the first quarter. We reclaimed the global distribution and sales rights for Paccal Vet and Doxophos Vet. This was facilitated by an official restructuring within Zoetis, Oasmia's previous distributor. Oasmia will not have any direct costs related to the reclaim. Due to this, we have established a subsidiary in the USA which will be responsible for sales and marketing of our product on the American market as of October 1. We are currently working intensively to build our own sales organization and expand the portfolio by acquiring further products. We are looking forward to a close collaboration with American veterinaries to provide them with a new treatment option which can extend the lives of their patients.
To further strengthen our presence in the USA, we have registered an application of listing on NASDAQ USA.
After the closing date of the quarter, we were pleased to present results from a study which showed that Paclical and Abraxane had an almost identical pharmacokinetic profile for women with metastatic breast cancer. This is a strong indication that both pharmaceuticals have a similar effect, although Paclical does not contain any human albumin. In the light of this, we are looking forward to a new exciting phase in Oasmia's development. Abraxane, marketed by Celgene, is the only similar product currently on the market and sales is estimated to exceed one billion USD in 2015", comments Mikael Asp, 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 Stockholm and at the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
Since the April 2015 market authorization of Paclical by the Russian Ministry of Health, work is now in progress with the planned launch in Russia during the second half of 2015. Paclical, is the first completely water soluble cancer drug containing paclitaxel that received market approval. It will be marketed by Oasmia's Russian distributor, Pharmasyntez, both in Russia and the CIS countries.
In July 2014, Paccal Vet-CA1 was launched on the US market by Abbott Animal Health. In February 2015, Zoetis announced that they had completed the acquisition of Abbott Animal Health. In July 2015, Oasmia announced that Zoetis had terminated the collaboration agreement between the companies and that Oasmia has regained the exclusive global rights to Paccal Vet and Doxophos Vet. At the same time Oasmia announced that the company will take responsibility for marketing and sales of Paccal Vet-CA1 and has established its own sales company in the USA, Oasmia Pharmaceutical, Inc. The transfer process is estimated to be completed in September 2015 and the official launch will be carried out during the VCS (Veterinary Cancer Society) annual conference in October.
PRODUCT DEVELOPMENT
HUMAN HEALTH
Paclical
In April 2015, Oasmia´s cancer product Paclical received market authorization in Russia by the Russian Ministry of Health. Paclical is the first completely water soluble cancer drug containing paclitaxel approved for sale. Paclical is planned for launch in Russia in the second half of 2015.
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 new annual cases globally. The total number of patients in the study was 789, and all patients have been followed up regarding progression free survival (PFS). 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 combinations with carboplatin, have similar progression free survival. In October 2014, the company announced the results from the study that shows that Paclical has a positive risk/benefit profile compared to standard treatment.
The final study report for the clinical study is still on-going and the study report will constitute the foundation for a submission of a Marketing Authorization Application to the EMA (European Medicines Agency) in 2015.
Doxophos
Doxophos is a patented formulation of the cytostatic doxorubicin in combination with XR-17. Doxorubicin is one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation and is now planning a clinical Phase I study on the indication metastatic breast cancer.
Docecal
Docecal is a patented formulation of the cytostatic docetaxel in combination with XR-17 for treatment of metastatic breast cancer. Docecal is now entering a clinical phase and the company is planning for a clinical phase I study and a safety and tolerance study.
OAS-19
OAS-19 is the first cancer product 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 water solubility can be combined. Pre-clinical studies performed in 2013 with OAS-19 have shown promising results.
| REG./ PHASE! PHASE II PHASE III |
RIGHTS | |||||||
|---|---|---|---|---|---|---|---|---|
| CANDIDATE | INDICATION | PRE-CLINICAL | APPROVAL | GEOGRAPHY | PARTNER | |||
| Paclical (paclitaxel) |
Ovarian cancer | Ongoing | Global [ex-RUS/CIS] |
oasmia | ||||
| Ovarian cancer | Approved | RUS/CIS | EPHARMASYNTEZ | |||||
| Metastatic breast cancer |
Ongoing | Global | oasmia | |||||
| Doxophos (doxorubicin) |
Breast cancer | Planning | Global | oasmia | ||||
| Docecal (docetaxel) |
Breast cancer | Ongoing | Planning | Global | oasmia | |||
| OAS-19 (combination) |
Various cancers | Ongoing | Global | oasmia | ||||
| Additional partners: Paclical partnered with Medison Phorma in Turkey & Israel. |
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 and intended for use 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 the indication squamous cell carcinoma and the first dog in the mammary cancer study was treated in the quarter.
Oasmia 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 included in the study have been treated. If the result is in line with the expectations, the company will submit an application for market approval to the European pharmaceutical authority EMA. 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.
In February 2015, a Phase II study was initiated and whose primary goal is to assess response rate in the treated dogs. The study will continue throughout 2016. The Phase II study will form the basis for a conditional approval application in the US for the treatment of lymphoma in dogs. In a follow-up study, the dogs will be followed to progression.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE! | PHASE!I | PHASE III | REG./ APPROVAL |
GEOGRAPHY | RIGHTS PARTNER |
|---|---|---|---|---|---|---|---|---|
| Paccal Ver e - CA1 (pacifiaxel) |
Mammary | Ongoing | Conditionally approved |
Global $ ax-IAP $ |
oasmia | |||
| Souamous cnl | Planned for full approval |
Conditionally approved |
Global Lex-LAPI |
oasmia | ||||
| Mast cell | Ongoing | Global Tex-LAP |
oasmia | |||||
| Doxophos Vet (doxorubicin) |
Lymphoma | Ongoing | Global | oasmia |
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
Oasmia has applied to be listed on NASDAQ in the USA, and has carried out a roadshow for American investors
In July, 2015 the company submitted an application to be listed on the NASDAQ Stock Exchange, "Registration Statement Form F-1/A", to USA's Securities and Exchange Commission. This application was updated and registered in the final version on August 14. Ladenburg Thalmann are financial advisors in connection with the application. An Investor Roadshow was performed in August, 2015.
Oasmia has established a sales company in the USA
Paccal Vet-CA1 was formerly distributed in the USA by Zoetis, a veterinary pharmaceutical company that was spun off from Pfizer in 2013. Due to an officially ongoing rationalization programme at Zoetis, amongst other things, Oasmia decided to create a sales organization of its own and to be responsible for marketing and sales. The company reclaimed the exclusive global rights to Paccal Vet and Doxophos Vet, and started a company named Oasmia Pharmaceutical Inc, with the purpose to market products in the USA and promote Oasmia's future growth. During the transfer process between the parties, business is proceeding as previously and the process is estimated to be completed in September 2015.
Changes in Oasmia's Board of Directors and Management
At the extraordinary general meeting held on May 28, 2015, Hans Liljeblad and Lars Bergkvist were elected as new Members of the Board. A resolution was also made that Julian Aleksov succeeds Joel Citron as Executive Chairman of the Board. The Board appointed Mikael Asp as new CEO for Oasmia. Bo Cederstrand, Horst Domdey, Alexander Kotsinas and Hans Sundin remain members of the board.
The extraordinary general meeting authorized the Board to make decisions on issue of new shares and convertible debt instruments
The extraordinary general meeting resolved, in accordance with the board proposal, to authorize the board, on one or more occasions until the next annual general meeting, to resolve on an issue of shares, warrants and/or convertible instruments. The board should not take decisions that the share capital would be increased by more than 1,500,000 SEK in addition to the share capital increase that may occur as a result of previous authorization also applies until the next annual general meeting.
Oasmia obtained extension of bank loan of SEK 20 million
Oasmia received extension of its bank loan of 20 million with an earlier maturity date of June 30, 2015. Now, the loan is due for payment on December 30, 2015.
Share price development during the period (SEK)
EVENTS AFTER CLOSING DAY
Oasmia published positive results for Paclical in a head-to-head comparative study with Abraxane
In August, 2015, Oasmia announced positive results from a head-to-head comparison study of its lead human cancer product Paclical and Celgene's Abraxane, which show similar pharmacokinetic (PK) profiles. The study was conducted in women with metastatic breast cancer.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2015 | 2014 | 2014/15 | |
|---|---|---|---|
| TSEK | May-July | May-July | May-Apr |
| Net sales | 219 | 994 | 2,070 |
| Capitalized development cost | 5,539 | 4,501 | 16,797 |
| Other operating income | 1 | 92 | 221 |
| Operating expenses | -43,578 | -35,937 | -127,313 |
| Operating income | -37,819 | -30,351 | -108,225 |
| Net income after tax | -39,819 | -32,989 | -117,497 |
| Earnings per share, before and after dilution, in SEK* | -0.41 | -0.38 | -1.28 |
| Comprehensive income for the period | -39,804 | -32,989 | -117,497 |
* Recalculation of historical values has been made taking into account capitalization issue elements in the rights issue carried out in the third quarter of 2014/15
FIRST QUARTER
May 1 – July 31, 2015
Net sales
Net sales amounted to TSEK 219 (994) and consisted principally of revenues from performed research assignments. During the corresponding period previous year, net sales mainly consisted of revenues from Paccal Vet-CA1. Oasmia's revenues from Paccal Vet-CA1 consist of an invoiced price per vial upon delivery and a royalty calculated on Zoetis net sales of the product. Altogether, these revenues amounted to TSEK 11 (982) during the first quarter.
Capitalized development costs
Capitalized development costs, which refer to Phase III clinical trials for the product candidates Paclical and Paccal Vet, amounted to TSEK 5,539 (4,501). Of the capitalization, Paclical comprised TSEK 3,265 (2,959) and Paccal Vet comprised TSEK 2,275 (1,542).
Operating expenses
Operating expenses including depreciation, amortization and impairments were higher compared to the corresponding period previous year and amounted to TSEK 43,578 (35,937).
The increase is primarily due to increased costs for clinical trials and regulatory expenses. This was primarily due to that the company is in the starting phase of the Docecal clinical program and an explorative study with XR-17. In addition, employee benefit expenses have increased due to increased number of employees and raised qualification level and thus increased salary levels.
Costs for raw materials, and supplies for manufacturing and supply expenses have decreased in the quarter.
The number of employees at the end of the quarter was 80 (75).
Net income for the period
Net income after tax was TSEK -39,819 (-32,989). The decrease in net income compared to the corresponding period previous year was mainly attributable to increased operating expenses, see above. This was partly offset by decreased interest expenses, attributable to lower debt this quarter.
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 -24,338 (-31,058). Operating income was significantly lower than the corresponding period previous year, but was offset by positive changes in working capital.
Cash flow from investing activities amounted to TSEK -22,415 (-5,927). Disposals of short term investments in an interest fund provided TSEK 29,500 (-) in liquid assets. Of the investments in the period, net investments in intangible assets amounted to TSEK 5,811 (4,501) and consisted of capital-
ized development costs TSEK 5,539 (4,501) and of patents TSEK 271 (-). Net investments in property, plant and equipment amounted to TSEK 1,274 (1,426) and mainly consisted of production equipment.
Financing
In May 2015, Oasmia received an extension of bank loan of TSEK 20,000 with an earlier maturity date of June 30, 2015. Now, the loan is due for payment on December 30, 2015.
The company carries a loan from Nexttobe AB amounting to TSEK 87,000 (105,000) which carries an interest of 8.5 % until December 30, 2015.
Financial position
The consolidated cash and cash equivalents at the end of the period amounted to TSEK 24,929 (58,088). The company has TSEK 20,627 (-) invested in short-term interest fund, whereof TSEK 20,000 is restricted as security for a bank loan. The interest-bearing liabilities were TSEK 107,000 (145,000) and consist of a loan from Nexttobe and a bank loan.
At the end of the period, unutilized credit facilities 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 335,906 (295,750), the Equity/Assets ratio was 69 % (61 %), and the Net debt/Equity ratio was 18 % (29 %).
Future financing
Oasmia has two products approved, but this does not yet create a sufficient cash flow from its own business. For this reason, Oasmia continuously works with various financing alternatives. Available consolidated liquid assets and unutilized credit facilities, as of July 31, 2015, are not sufficient to provide the required capital to pursue 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.
The parent company
The parent company net sales for the period amounted to TSEK 219 (994) and net income before tax amounted to TSEK -39,740 (-32,985). The parent company's cash and bank balances at the end of the period amounted to TSEK 23,834 (58,085) and short-term investments amounted to TSEK 20,627 (-).
Key ratios and other information
| 2015 | 2014 | 2014/15 | |
|---|---|---|---|
| May-July | May-July | May-Apr | |
| Number of shares at the end of the period, before and after dilution, in thousands* | 97,858 | 88,689 | 97,858 |
| Weighted average number of shares, before and after dilution, in thousands* | 97,858 | 86,801 | 91,655 |
| Earnings per share, before and after dilution, in SEK* | -0.41 | -0.38 | -1.28 |
| Equity per share, SEK* | 3.43 | 3.33 | 3.84 |
| Equity/Assets ratio, % | 69 | 61 | 73 |
| Net debt, TSEK | 61,444 | 86,912 | 30,010 |
| Net debt/Equity ratio, % | 18 | 29 | 8 |
| Return on total assets, % | neg | neg | neg |
| Return on equity, % | neg | neg | neg |
| Number of employees at the end of the period | 80 | 75 | 79 |
*Recalculation of historical values has been made taking into account capitalization issue elements in the rights issue carried out in the third quarter of 2014/15.
Definitions
Earnings per share: Income for the period attributable to parent company shareholders divided by the weighted average number of shares, before and after dilution, in the period.
Equity per share: Equity as a ratio of the number of shares at the end of the period.
Equity/assets ratio: Equity as a ratio of total assets.
Net debt: Total borrowing (comprising the balance sheet items short-term and long-term borrowings and liabilities to credit institutions) with deduction of cash, cash equivalents and short-term investments.
Net debt/Equity ratio: Net debt as a ratio of equity.
Return on total assets: Income before interest expenses as a percentage of the average balance sheet total.
Return on equity: Income after financial items as a ratio of average equity.
Consolidated income statement
| 2015 | 2014 | 2014/15 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-Apr |
| Net sales | 219 | 994 | 2,070 | |
| Capitalized development cost | 5,539 | 4,501 | 16,797 | |
| Other operating income | 1 | 92 | 221 | |
| Raw materials, consumables and goods for resale | -1,444 | -4,249 | -10,062 | |
| Other external expenses | -26,246 | -17,185 | -60,740 | |
| Employee benefit expenses | -14,594 | -13,173 | -50,530 | |
| Depreciation, amortization and impairment | -1,295 | -1,331 | -5,190 | |
| Other operating expenses | - | - | -792 | |
| Operating income | -37,819 | -30,351 | -108,225 | |
| Financial income | 8 | 8 | 210 | |
| Financial expenses | -2,008 | -2,647 | -9,482 | |
| Financial income and expenses - net | -2,000 | -2,638 | -9,272 | |
| Income before taxes | -39,819 | -32,989 | -117,497 | |
| Income taxes | 2 | - | - | - |
| Income for the period | -39,819 | -32,989 | -117,497 | |
| Income for the period attributable to: | ||||
| Parent company shareholders | -39,819 | -32,989 | -117,497 | |
| Earnings per share before and after dilution, SEK | -0.41 | -0.38 | -1.28 |
Consolidated statement of comprehensive income
| 2015 | 2014 | 2014/15 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-Apr |
| Income for the period | -39,819 | -32,989 | -117,497 | |
| Other comprehensive income | ||||
| Items that may be reclassified subsequently to the income statement: | ||||
| Translation differences | 15 | - | - | |
| Total other comprehensive income | 15 | 0 | 0 | |
| Comprehensive income for the period | -39,804 | -32,989 | -117,497 | |
| Comprehensive income for the period attributable to: | ||||
| Parent company shareholders | -39,804 | -32,989 | -117,497 | |
| Comprehensive earnings per share before and after dilution, SEK | -0.41 | -0.38 | -1.28 |
Consolidated statement of financial position
| TSEK | Note | 2015-07-31 | 2014-07-31 | 2015-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 23,112 | 24,783 | 22,852 | |
| Capitalized development cost | 3 | 398,713 | 380,876 | 393,173 |
| Other intangible assets | 11,843 | 13,041 | 11,852 | |
| Financial non-current assets | 2 | 2 | 2 | |
| Total non-current assets | 433,670 | 418,702 | 427,879 | |
| Current assets | ||||
| Inventories | 6,326 | 2,717 | 5,341 | |
| Accounts receivable | 200 | 1,036 | 105 | |
| Other current receivables | 2,579 | 3,183 | 2,566 | |
| Prepaid expenses and accrued income | 1,783 | 1,287 | 1,687 | |
| Short-term investments | 4 | 20,627 | - | 50,153 |
| Cash and cash equivalents | 24,929 | 58,088 | 26,837 | |
| Total current assets | 56,444 | 66,310 | 86,690 | |
| TOTAL ASSETS | 490,114 | 485,013 | 514,569 | |
| EQUITY | ||||
| Equity attributable to parent company shareholders | ||||
| Share capital | 9,786 | 8,807 | 9,786 | |
| Other capital provided | 850,996 | 687,506 | 850,996 | |
| Reserves | 15 | - | - | |
| Retained earnings including income for the period | -524,890 | -400,564 | -485,071 | |
| Total equity | 335,906 | 295,750 | 375,710 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | - | 891 | - | |
| Total non-current liabilities | 0 | 891 | 0 | |
| Current liabilities | ||||
| Liabilities to credit institutions | 20,000 | 40,000 | 20,000 | |
| Short-term borrowings | 5 | 87,000 | 105,000 | 87,000 |
| Accounts payable | 23,032 | 17,125 | 14,017 | |
| Other current liabilities | 1,890 | 1,621 | 1,796 | |
| Accrued expenses and deferred income | 22,286 | 24,625 | 16,045 | |
| Total current liabilities | 154,208 | 188,372 | 138,858 | |
| Total liabilities | 154,208 | 189,263 | 138,858 | |
| TOTAL EQUITY AND LIABILITIES | 490,114 | 485,013 | 514,569 |
Any contingent liabilities and pledged assets are reported in note 6.
Consolidated statement of changes in equity
| Attributable to parent company shareholders | |||||
|---|---|---|---|---|---|
| Other | Retained | ||||
| TSEK | Share capital | capital provided | Reserves | earnings | Total equity |
| Opening balance as of May 1, 2014 | 8,557 | 640,924 | 0 | -367,574 | 281,907 |
| Comprehensive income for the period | - | - | - | -32,989 | -32,989 |
| New share issue | 250 | 49,750 | - | - | 50,000 |
| Issue expenses | - | -3,168 | - | - | -3,168 |
| Closing balance as of July 31, 2014 | 8,807 | 687,506 | 0 | -400,564 | 295,750 |
| Opening balance as of May 1, 2014 | 8,557 | 640,924 | 0 | -367,574 | 281,907 |
| Comprehensive income for the year | - | - | - | -117,497 | -117,497 |
| New share issues | 1,229 | 224,916 | - | - | 226,145 |
| Issue expenses | - | -14,844 | - | - | -14,844 |
| Closing balance as of April 30, 2015 | 9,786 | 850,996 | 0 | -485,071 | 375,710 |
| Opening balance as of May 1, 2015 | 9,786 | 850,996 | 0 | -485,071 | 375,710 |
| Income for the period | - | - | - | -39,819 | -39,819 |
| Other comprehensive income | - | - | 15 | - | 15 |
| Comprehensive income for the period | 0 | 0 | 15 | -39,819 | -39,804 |
| Closing balance as of July 31, 2015 | 9,786 | 850,996 | 15 | -524,890 | 335,906 |
| Consolidated cash flow statement | |||||
| 2015 | 2014 | 2014/15 | |||
| TSEK | Note | May-July | May-July | May-Apr |
| Operating activities | ||||
|---|---|---|---|---|
| Operating income before financial items | -37,819 | -30,351 | -108,225 | |
| Adjustments for non-cash items | 1,295 | 1,331 | 5,982 | |
| Interest received | 8 | 8 | 56 | |
| Interest paid | -98 | -132 | -1,384 | |
| Cash flow from operating activities before | ||||
| changes in working capital | -36,615 | -29,143 | -103,570 | |
| Change in working capital | ||||
| Change in inventories | -985 | -1,060 | -3,684 | |
| Change in accounts receivable | -95 | -988 | -56 | |
| Change in other current receivables | -108 | -139 | 77 | |
| Change in accounts payable | 9,014 | -378 | -3,486 | |
| Change in other current liabilities | 4,451 | 651 | 3,055 | |
| Cash flow from operating activities | -24,338 | -31,058 | -107,665 | |
| Investing activities | ||||
| Investments in intangible assets | -5,811 | -4,501 | -17,406 | |
| Disposal of intangible assets | - | - | 1,200 | |
| Investments in property, plant and equipment | -1,274 | -1,426 | -3,621 | |
| Disposal of property, plant and equipment | - | - | 72 | |
| Investments in short-term investments | - | - | -80,000 | |
| Disposal of short-term investments | 4 | 29,500 | - | 30,000 |
| Cash flow from investing activities | 22,415 | -5,927 | -69,755 | |
| Financing activities | ||||
| Decrease in liabilities to credit institutions | - | - | -20,000 | |
| New share issue | - | 50,000 | 190,861 | |
| Issue expenses | - | -3,168 | -14,844 | |
| Cash flow from financing activities | 0 | 46,832 | 156,017 | |
| Cash flow for the period | -1,923 | 9,847 | -21,404 | |
| Exchange rate differences in cash and cash equivalents | 15 | - | - | |
| Cash and cash equivalents at beginning of the period | 26,837 | 48,241 | 48,241 | |
| Cash and cash equivalents at end of the period | 24,929 | 58,088 | 26,837 |
Parent company income statement
| 2015 | 2014 | 2014/15 | ||
|---|---|---|---|---|
| TSEK | Note | May-July | May-July | May-Apr |
| Net sales | 219 | 994 | 2,070 | |
| Capitalized development cost | 5,539 | 4,501 | 16,797 | |
| Other operating income | 1 | 92 | 221 | |
| Raw materials and consumables | -1,444 | -4,249 | -10,062 | |
| Other external expenses | -26,221 | -17,181 | -60,709 | |
| Employee benefit expenses | -14,540 | -13,173 | -50,530 | |
| Depreciation, amortization and impairment of tangible and intangible assets | -1,295 | -1,331 | -5,190 | |
| Other operating expenses | - | - | -792 | |
| Operating income | -37,739 | -30,347 | -108,194 | |
| Result from participations in Group companies | - | - | -75 | |
| Other interest income and similar income | 8 | 8 | 210 | |
| Interest expenses and similar expenses | -2,008 | -2,647 | -9,482 | |
| Financial items, net | -2,000 | -2,638 | -9,347 | |
| Income before tax | -39,740 | -32,985 | -117,541 | |
| Income taxes | 2 | - | - | - |
| Income for the period | -39,740 | -32,985 | -117,541 |
Parent company balance sheet
| TSEK | Note | 2015-07-31 | 2014-07-31 | 2015-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible non-current assets | ||||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 398,713 | 380,876 | 393,173 |
| similar rights | 11,843 | 13,041 | 11,852 | |
| Tangible non-current assets Equipment, tools, fixtures and fittings |
22,744 | 22,350 | 21,611 | |
| Construction in progress and advance payments for tangible non-current assets |
368 | 2,433 | 1,241 | |
| Financial non-current assets | ||||
| Participations in group companies | 5 | 1,258 | 110 | 110 |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 434,927 | 418,811 | 427,988 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 6,326 | 2,717 | 5,341 | |
| 6,326 | 2,717 | 5,341 | ||
| Current receivables | ||||
| Accounts receivable | 200 | 1,036 | 105 | |
| Other current receivables | 2,578 | 3,181 | 2,565 | |
| Prepaid expenses and accrued income | 1,777 | 1,281 | 1,678 | |
| 4,555 | 5,498 | 4,348 | ||
| Short-term investments | 4 | 20,627 | - | 50,153 |
| Cash and bank balances | 23,834 | 58,085 | 26,833 | |
| Total current assets | 55,342 | 66,300 | 86,675 | |
| TOTAL ASSETS | 490,268 | 485,111 | 514,663 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 9,786 | 8,807 | 9,786 | |
| Statutory reserve | 4,620 | 4,620 | 4,620 | |
| 14,406 | 13,427 | 14,406 | ||
| Non-restricted equity | ||||
| Share premium reserve | 850,996 | 687,506 | 850,996 | |
| Retained earnings | -489,921 | -372,380 | -372,380 | |
| Income for the period | -39,740 | -32,985 | -117,541 | |
| 321,335 | 282,141 | 361,075 | ||
| Total equity | 335,741 | 295,568 | 375,480 | |
| Non-current liabilities | ||||
| Other non-current liabilities | - | 891 | - | |
| Total non-current liabilities | 0 | 891 | 0 | |
| Current liabilities | ||||
| Liabilities to credit institutions | 20,000 | 40,000 | 20,000 | |
| Short-term borrowings | 5 | 87,000 | 105,000 | 87,000 |
| Accounts payable | 23,027 | 17,125 | 14,017 | |
| Liabilities to group companies | 324 | 281 | 324 | |
| Other current liabilities | 1,890 | 1,621 | 1,796 | |
| Accrued expenses and deferred income | 22,286 | 24,625 | 16,045 | |
| Total Current liabilities | 154,528 | 188,653 | 139,183 | |
| TOTAL EQUITY AND LIABILITIES | 490,268 | 485,111 | 514,663 | |
| Contingent liabilities and pledged assets | ||||
| Contingent liabilities | 6 | - | - | - |
| Pledged assets | 6 | 28,000 | 8,000 | 28,000 |
Parent company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| Statutory | Non-restricted | |||
| TSEK | Share capital | reserve | equity | Total equity |
| 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 | - | - | -32,985 | -32,985 |
| Closing balance as of July 31, 2014 | 8,807 | 4,620 | 282,141 | 295,568 |
| Opening balance as of May 1, 2014 | 8,557 | 4,620 | 268,544 | 281,721 |
| New share issues | 1,229 | - | 224,916 | 226,145 |
| Issue expenses | - | - | -14,844 | -14,844 |
| Income for the year | - | - | -117,541 | -117,541 |
| Closing balance as of April 30, 2015 | 9,786 | 4,620 | 361,075 | 375,480 |
| Opening balance as of May 1, 2015 | 9,786 | 4,620 | 361,075 | 375,480 |
| Income for the period | - | - | -39,740 | -39,740 |
| Closing balance as of July 31, 2015 | 9,786 | 4,620 | 321,335 | 335,741 |
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, 2014 – April 30, 2015. New or revised IFRS standards or interpretations by IFRIC that became effective since May 1, 2015, has not had any effect on Oasmia's financial reports. Similar to what was the case at the end of the previous fiscal year, financial instruments 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 Taxes
The group has accumulated losses carried forward, related to previous fiscal years and the period, amounting to TSEK 561,059 (437,205) and the parent company has such amounting to TSEK 551,825 (428,002). There are currently no firm indications of when tax losses carried forward can be utilized against future profits and therefore no deferred tax asset has been considered in the Balance Sheet.
Note 3 Capitalized development cost
Oasmia capitalizes development cost consisting of the company's investments in clinical phase III trials for the product candidates Paclical and Paccal Vet. The accumulated assets per product candidate are disclosed below.
| TSEK | 2015-07-31 | 2014-07-31 | 2015-04-30 |
|---|---|---|---|
| Paclical | 293,373 | 283,878 | 290,108 |
| Paccal Vet | 105,340 | 96,998 | 103,065 |
| Total | 398,713 | 380,876 | 393,173 |
Note 4 Short-term investments
Liquid assets not utilized in the daily operation have been invested in interest funds that invest in safe interest bearing securities and other interest instruments. As most securities included in these funds have a remaining maturity exceeding 3 months, these have been valued to fair value and disclosed as Short-term investments in the Balance Sheet.
Note 5 Transactions with related parties
On July 31, 2015 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 July 31, 2015, this credit was completely unutilized, also as of July 31, 2014.
On July 31, 2015, Oasmia carried a loan from Nexttobe AB amounting to TSEK 87,000 (105,000). During 2015 the loan carries an interest of 8.5 % that will be paid when the loan is due on December 30, 2015. As of July 31, 2015, accrued interest expense for the loan amounted to TSEK 4,295 (13,761).
In the period, Oasmia Pharmaceutical AB established a wholly owned subsidiary in Nevada, USA, Oasmia Pharmaceutical, Inc. In addition to a capital contribution amounting to TSEK 1,148 to finance the subsidiary's initial activities, no transactions between Oasmia Pharmaceutical AB and the subsidiary have taken place.
No significant further transactions with related parties have been made in the period apart from remuneration to employees.
Note 6 Contingent liabilities and Pledged assets
The parent company has TSEK 20,000 placed in a restricted interest fund account as a pledge for a bank loan of the corresponding amount. 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, 2014 – April 30, 2015. No additional risks beyond those described therein have been judged significant.
The Board of Directors and the CEO of Oasmia Pharmaceutical AB ensures that this interim report gives a fair view 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, September 2, 2015 | ||
|---|---|---|
| Julian Aleksov, Chairman | Bo Cederstrand, Member | Prof. Dr. Horst Domdey, Member |
| Hans Sundin, Member | Alexander Kotsinas, Member | Hans Liljeblad, Member |
| Lars Bergkvist, Member | Mikael Asp, CEO |
The information in this interim report is such that Oasmia Pharmaceutical AB (publ) must publish according to the Swedish Securities Markets Act. The information was delivered for publication on September 3, 2015 at 8.15 am.
This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.
_________________________________________________________________________________
This report has not been reviewed by the company auditors.
COMPANY INFORMATION 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, E-mail: [email protected]
Questions concerning the report are answered by: Anders Lundin, CFO Tel: +46 70 209 63 00 E-mail: [email protected]
UPCOMING REPORT DATES
| Interim report May – October 2015 | 2015-12-03 |
|---|---|
| Interim report May 2015 – January 2016 | 2016-03-03 |
| Year-end report May 2015 – April 2016 | 2016-06-03 |
| Interim report May – July 2016 | 2016-09-02 |
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 July 31, 2015 which was 9.4338 SEK per one EUR (source: Swedish Central Bank).
| 2015 | 2014 | 2014/15 | |
|---|---|---|---|
| € thousand if nothing else is stated | May-July | May-July | May-Apr |
| Key ratios and other information | |||
| Number of shares at the end of the period, before and after dilution, in thousands* | 97,858 | 88,689 | 97,858 |
| Weighted average number of shares, before and after dilution, in thousands* | 97,858 | 86,801 | 91,655 |
| Earnings per share, before and after dilution, in €* | -0.04 | -0.04 | -0.14 |
| Equity per share, €* | 0.36 | 0.35 | 0.41 |
| Equity/Assets ratio, % | 69 | 61 | 73 |
| Net debt, € thousand | 6,513 | 9,213 | 3,181 |
| Net debt/Equity ratio, % | 18 | 29 | 8 |
| Number of employees at the end of the period | 80 | 75 | 79 |
| Consolidated income statement in brief | |||
| Net sales | 23 | 105 | 219 |
| Capitalized development cost | 587 | 477 | 1,781 |
| Operating income | -4,009 | -3,217 | -11,472 |
| Financial income and expenses - net | -212 | -280 | -983 |
| Income before taxes | -4,221 | -3,497 | -12,455 |
| Income for the period | -4,221 | -3,497 | -12,455 |
| Comprehensive income for the period | -4,219 | -3,497 | -12,455 |
| Consolidated statement of financial position in brief | |||
| Total non-current assets | 45,970 | 44,383 | 45,356 |
| Total current assets | 5,983 | 7,029 | 9,189 |
| Total assets | 51,953 | 51,412 | 54,545 |
| Total equity | 35,607 | 31,350 | 39,826 |
| Total non-current liabilities | 0 | 94 | 0 |
| Total current liabilities | 16,346 | 19,968 | 14,719 |
| Total liabilities | 16,346 | 20,062 | 14,719 |
| Total equity and liabilities | 51,953 | 51,412 | 54,545 |
| Consolidated cash flow statement in brief | |||
| Operating income before financial items | -4,009 | -3,217 | -11,472 |
| Cash flow from operating activities before changes in working capital | -3,881 | -3,089 | -10,979 |
| Cash flow from operating activities | -2,580 | -3,292 | -11,413 |
| Cash flow from investing activities | 2,376 | -628 | -7,394 |
| Cash flow from financing activities | 0 | 4,964 | 16,538 |
| Cash flow for the period | -204 | 1,044 | -2,269 |
| Cash and cash equivalents at end of the period | 2,643 | 6,157 | 2,845 |
* Recalculation of historical values has been made taking into account capitalization issue elements in the rights issue carried out in the third quarter of 2014/15