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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