Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Vivesto Interim / Quarterly Report 2017

Sep 1, 2017

3124_10-q_2017-09-01_6db8cac4-e057-44a2-b293-da271029010c.pdf

Interim / Quarterly Report

Open in viewer

Opens in your device viewer

Oasmia Pharmaceutical AB (publ)

Interim report for the period May – July 2017

Doxophos approved in Russia

FIRST QUARTER May 1 – July 31, 2017

EVENTS AFTER CLOSING DAY

Market approval received for Doxophos in Russia

COMMENTS FROM THE CEO:

Dear Shareholders,

The company took several important steps forward during the first quarter of this financial year (May 1, 2017 to July 31, 2017), even though these were the summer months.

We eagerly await EMA's decision regarding Apealea. Many activities are ongoing in parallel with this, not least the two studies on Docecal are continuing according to plan and we are currently working on compiling the study which will form the basis of our filing for conditional approval for Doxophos Vet in the US pursuant to MUMS designation.

During the quarter the Board made the decision to transfer the company's veterinary assets to our American subsidiary. The transaction is being carried out with a view to giving the company a stable financial foundation with external financing, which enables further development and commercialization on the American market, the most important market for this type of treatment.

During the quarter Oasmia also strengthened its cash balances through a new share issue of just over MSEK 160, before issue-related expenses. This financing will stabilize the company and further strengthen our focus on commercialization of our products.

During the quarter the company entered into an exclusive agreement with Hetero Group for sales and distribution of our products in Russia and the CIS countries. Furthermore, a letter of intent was entered into for India and Latin America, which will be negotiated separately. Hetero Group is an international pharmaceutical company with more than 15,000 employees in over 100 countries. Hetero is expanding in Russia and will continue to intensify marketing of Paclical. They have worked quickly and we are delighted to have seen the first order for Paclical come during August.

We held a capital markets day in Stockholm on June 15, when we met and discussed matters with many of our shareholders. The presentations from, amongst others, our advisor Ulf Jungnelius and our Chief Medical Officer (Vet) Henrik Rönnberg were much appreciated. The management team also described the company in general and business strategies in particular. We thank everyone who attended and everyone who has looked at the presentations on our website.

After the end of the quarter the company received market approval for Doxophos in Russia. Our partner Hetero Group will thus be marketing and distributing two Oasmia products. Doxophos is based on doxorubicin, which is used for several of the largest cancer indications. The doxorubicin formulations on the market are expected to sell for approximately USD 1.4 billion in 2024.

We are all looking forward to an exciting autumn.

Kind regards,

CEO Mikael Asp

Oasmia Pharmaceutical AB develops, manufactures, markets and sells a new generation of drugs within human and veterinary oncology. Product development aims to produce novel formulations based on well-established cytostatics which, in comparison with current alternatives, display improved properties, a reduced side-effect profile and expanded therapeutic areas. Product development is based on inhouse research within nanotechnology and company patents. The company share is listed on NASDAQ Stockholm, the NASDAQ Capital Market in the US and the Frankfurt Stock Exchange.

BUSINESS ACTIVITIES

In the middle of August the company submitted answers to questions from EMA (European Medicines Agency) regarding Apealea. The application is being processed and notification from EMA is expected shortly. Preparations for a pre-submission meeting and filing with the U.S. Food and Drug Administration (FDA) are ongoing in parallel. In April 2016, Paclical/Apealea reported that all endpoints of the phase III study on ovarian cancer had been achieved with positive results, which serves as a basis for submissions to authorities.

In Russia the company's new partner Hetero Group has begun to work actively on the marketing of Paclical, which is the only water-soluble formulation of paclitaxel that can be administered at a higher dose and which is reimbursed by the Russian health insurance system. Substantial efforts have already been made at oncology congresses as well as directly to inform and educate cancer clinicians regarding the product. These efforts will be intensified with Hetero. The company is working on a new long-term major strategic and structural solution together with Hetero to enable distribution and marketing of Paclical to take off and the first order has already come in during August. Hetero also has the rights to Doxophos, which received market approval in August. Management stands by its conviction concerning the great market potential for Paclical in Russia and the CIS.

Oasmia has made a decision to transfer all assets in the veterinary medicine area to its currently whollyowned subsidiary in the US. In order to do this, this part of the business has been separately valued by an external party, who set the value of the products Paccal Vet and Doxophos Vet in the range of MSEK 660 to 720. At the same time the company has engaged an American investment bank in the work of externally financing the veterinary part. The principal market for this kind of treatment is in the US and it is also in the US that potential collaboration partners are to be found.

PRODUCT DEVELOPMENT

HUMAN HEALTH

Paclical / Apealea

Paclical is a patented formulation of paclitaxel in combination with Oasmia's patented XR17 technology. 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 the treatment of ovarian cancer, an indication with slightly less than 250,000 new annual cases globally. The final phase III study report, which was completed during the third calendar quarter of 2015, was included as part of the marketing authorization application for the EU that was submitted to EMA in February 2016. In April 2016, the company presented primary positive overall survival data (OS data) from the study. This data will form the basis of the application to the FDA in the US for market approval.

Doxophos

Doxophos is a patented formulation of the cytostatic doxorubicin in combination with XR17. Doxorubicin is one of the most effective and widely used substances for the treatment of cancer. The company has received market approval for Doxophos in Russia as a hybrid pharmaceutical (improved generic pharmaceutical). Approval was received for many forms of cancer, amongst other things cancer of the blood, the skeleton, the breast, the prostate and the lungs.

Docecal is a patented formulation of the cytostatic docetaxel in combination with XR17 for the treatment of metastatic breast cancer. A clinical phase I study and a safety and tolerance study are currently in progress.

The clinical phase I study with Docecal is being performed in three countries. Patient recruitment began in September 2016 after approval by regulatory authorities and ethics committees. The safety and tolerance study began patient recruitment in March 2016.

XR17

XR17 is Oasmia's patented excipient, which can make insoluble molecules water soluble by forming nanoparticles, which are immediately dissolved in the bloodstream without using solvents. This results, amongst other things, in shorter infusion times and no need for premedication of patients, which are positive properties compared with existing drugs based on the same active ingredient.

In 2016, Oasmia completed a study to investigate the safety and tolerance of XR17 in healthy volunteers. The study confirms that the side effects of the excipient are mild and that safety is good.

OAS-19

OAS-19 is the first cancer drug to apply two active cytostatics in one infusion. It is the unique properties of XR17 that make this combination possible. This concept provides Oasmia with yet another dimension for drug development with multiple active substances in one micelle, where substances with different water solubility can also be combined. Previous pre-clinical studies have shown promising results.

KB9520

KB9520 is a substance acquired from Karo Pharma in November 2016. In pre-clinical studies, the substance has shown that it contributes to reduced side effects of treatment with cytostatics when intake of KB9520 and cytostatic treatment are combined. KB9520 has also demonstrated good efficacy for several types of cancer in pre-clinical models. In these disease models, treatment has shown a significant reduction in tumour size by stimulating apoptosis (programmed cell death) and inhibiting cell growth. The company has created an internal project group for the continued development of this substance. In parallel, the company is also looking for a partner with whom Oasmia can drive this forward.

Human Health
REG./ RIGHTS
CANDIDATE INDICATION PRE-CLINICAL PHASE I PHASE II PHASE III APPROVAL GEOGRAPHY PARTNER
Ovarian cancer Prep submission USA oasmia
Apealea/ Ovarian cancer Application
submitted*
EU oasmia
Paclical
(paclitaxel)
Ovarian cancer Approved** RUS
HETERO
Metastatic breast
cancer
Global oasmia
Doxophos
(doxorubicin)
All doxorubicin
indications
Hybrid Approved*** RUS $\frac{1}{\sqrt{11}}$ HETERO
Docecal
(docetaxel)
Breast cancer On-going Global oasmia
OAS-19
(combination)
Various cancers On-going Global oasmia
KB9520
(new chemical
entity)
Various cancers On-going Global oasmia
Additional nartners: Paclical nartnered with Medison Pharma in Turkey & Israel

Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (US) years for the indication, when market approval has been obtained.

ANIMAL HEALTH

Paccal Vet is a patented formulation of paclitaxel in combination with XR17 and is intended for use in dogs. In February 2014, Paccal Vet was granted conditional approval by the U.S. Food and Drug Administration, FDA, for treatment of mammary carcinoma and squamous cell carcinoma in dogs. Oasmia has been granted MUMS designation (see below) by the FDA for Paccal Vet in the treatment of mast cell tumours, mammary carcinoma and squamous cell carcinoma.

The company's main objective is to successfully expand product distribution and to reach out to a larger number of veterinary clinics. Paccal Vet has previously been available to a limited number of specialists in veterinary oncology. Oasmia expects that a change in therapy through changed dosage to reduce side effects and thereby increase quality of life for pets will make the product more attractive to veterinarians and pet owners. To achieve this objective, the company has withdrawn its conditional approval to allow the start of a new study to confirm a new treatment regimen.

Doxophos Vet

Doxophos Vet is a patented formulation of doxorubicin in combination with XR17. Oasmia is developing Doxophos Vet for the treatment of lymphoma, which is one of the most common cancers in dogs. Doxophos Vet has been granted MUMS designation (see below) in the US for the indication lymphoma.

In February 2015, a phase II study was initiated whose primary endpoint is response rate in the treated dogs. All dogs enrolled in the study have been treated and the dogs enrolled in a follow-up study have been monitored until progression. This study will form the basis of the application for approval to the FDA. We expect the results of the study to be reported in the autumn of 2017.

CANDIDATE INDICATION PRE-CLINICAL PHASE I PHASE II PHASE III REG./
APPROVAL
GEOGRAPHY RIGHTS
PARTNER
Paccal Vet ® Planned Global
(ex-JAP)
oasmia
(paclitaxel) Mast cell On-going Global
(ex-JAP)
oasmia
Doxophos Vet
(doxorubicin)
Lymphoma On-going 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

The company has entered into a new exclusive marketing and distribution agreement

Oasmia has entered into a new exclusive marketing and distribution agreement with Hetero Group regarding Russia and the rest of the CIS. Hetero is an international pharmaceutical Group with over 15,000 employees and a presence in over 100 countries that focuses on research, development, manufacturing and commercialization of a wide range of pharmaceuticals.

Decision taken to transfer the company's veterinary assets

The Board has made a decision to transfer the company's veterinary assets to its American subsidiary and appointed a New York-based investment bank to assist in the evaluation of financial and strategic alternatives for these. An independent valuation, carried out by one of the four large global audit firms, has assessed that the market value of the company's intellectual property rights regarding Oasmia's cancer products for animals, Paccal Vet and Doxophos Vet, is in the range of MSEK 660 to 720.

Capital markets day held on June 15

The company held a well-attended capital markets day in Stockholm on June 15 where we discussed the market and the strategy for the company's human and veterinary products.

Oasmia has carried out a rights issue of MSEK 163.9

The proceeds from the rights issue totalled approximately MSEK 163.9 (minus issue-related expenses). The rights issue will increase Oasmia's share capital by SEK 5,043,926.60 to SEK 17,653,743.20 when it is complete. The number of shares will increase by 50,439,266 to 176,537,432 shares. At the end of the quarter the entire issue had not yet been completely paid for or registered at the Swedish Companies Registration Office.

Previous convertible debt instruments replaced with new debt

The convertible programme that matured on June 9, 2017 has been replaced by debt in the form of nonnegotiable promissory notes. The total amount of the new debt corresponds to the previous convertible instruments' nominal amount, that is SEK 42 million in total. Of these promissory notes, TSEK 9,500 was repaid later on in the quarter at the same time as a new promissory note of TSEK 1,000 arose. At July 31 there were non-negotiable promissory notes totalling TSEK 33,500. The term of the new debt is up to one (1) year, but the debt may be pre-paid by Oasmia before it falls due. Interest on the debt accrues from June 9, 2017 at a rate of 8.5% annually and thus corresponds to the interest rate for the convertible instruments.

New warrants issued in accordance with the resolution adopted at an Extraordinary General Meeting

A total of 4,418,182 warrants have been acquired by the company's employees, 2,168,182 by the management team and other key persons and 2,250,000 by the Board (except for the Board members connected with the issuer, Alceco International S.A). If the warrants are fully exercised, the share capital will increase by SEK 441,818. Oasmia Incentive AB still holds 2,331,818 warrants. These warrants are intended to be held by the subsidiary so that they can be offered to new company employees and Board members, as previously communicated.

Update of the OAS-12DOC-BIO study given

Due to reporting in the EU Clinical Trials register, the company clarified that work at one of the participating clinics in the study has been terminated. This does not affect the ongoing study, which is proceeding as planned.

Share price performance during the quarter (SEK)

NASDAQ Stockholm

EVENTS AFTER CLOSING DAY

New market approval

Oasmia has received market approval for Doxophos in Russia, an important milestone after having recently changed marketing and distribution partner to Hetero Group. Doxophos is approved as a hybrid and is a unique nanoparticulate formulation of doxorubicin, one of the most commonly used anticancer substances in the world. Use of Doxorubicin includes treatment of large indications such as lung, breast and prostate cancer. Doxorubicin is the active substance in a family of oncology products including Adriamycin® and Doxil®, amongst others, sales of which are estimated to have amounted to MUSD 800 in 2015 and are expected to increase to USD 1.4 billion in 2024. As with Oasmia's first cancer drug, Paclical, Hetero Group is responsible for marketing and distribution of Doxophos in Russia.

FINANCIAL INFORMATION1

Consolidated income statement in brief

2017 2016 2016/17
TSEK May-Jul May-Jul May-Apr
Net sales 20 36 172
Change in inventories of products in progress and finished
goods (8) 378 (1,405)
Capitalized development costs 2,204 1,680 7,023
Other operating income 34 209 420
Operating expenses (30,670) (34,647) (146,691)
Operating income (loss) (28,421) (32,343) (140,481)
Net income (loss) for the period (31,713) (36,921) (160,243)
Earnings (loss) per share, before and after dilution in SEK* (0.23) (0.33) (1.39)
Comprehensive income (loss) for the period (31,715) (36,912) (160,230)

* Recalculation of historical values has been made taking into account capitalization issue elements in the rights issue carried out in July 2017.

FIRST QUARTER

May 1 – July 31, 2017

Net sales

Net sales amounted to TSEK 20 compared to TSEK 36 in the first quarter previous year and consisted of revenues from sales of supplies.

Change in inventories of products in progress and finished goods

The change in inventories of products in progress and finished goods amounted to TSEK (8) during the quarter compared to TSEK 378 in the first quarter previous year. The outcome the previous year derived from production of goods that were planned to be sold on the Russian market.

Capitalized development costs

Capitalized development costs, which refer to phase III clinical trials for the product candidates Paclical and Paccal Vet, amounted to TSEK 2,204 compared to TSEK 1,608 in the first quarter previous year. The capitalized development costs during the quarter are attributable in their entirety to Paclical. The Paccal Vet studies did not have any activity during the quarter. The corresponding quarter the previous year Paclical accounted for TSEK 1,550 of the capitalization and Paccal Vet for TSEK 130.

Other operating income

Other operating income amounted to TSEK 34 compared to TSEK 209 in the first quarter previous year.

Operating expenses

Operating expenses, including depreciation, amortization and impairments, were lower than for the corresponding quarter the previous year and amounted to TSEK 30,670 compared to TSEK 34,647 in the first quarter previous year. The decrease is mainly attributable to lower personnel costs, which in turn are attributable to the company's rationalization programme.

The number of employees at the end of the quarter was 61 compared to 77 in the first quarter previous year. The decrease in the number of employees is primarily due to the company's rationalization programme.

Net loss for the quarter

The net loss after tax was TSEK 31,713 compared to TSEK 36,921 in the first quarter previous year. The improvement in the net loss was primarily attributable to lower personnel costs. Furthermore, net financial items for the quarter involved an improvement, TSEK (3,292) compared to TSEK (4,579) in the first quarter previous year, which is attributable to the lower interest-bearing liabilities this year, see "Financial position" below.

The activities of the Oasmia Group were not affected by seasonal variation or cyclical effects.

1 Figures within parentheses represent negative amounts.

Cash flow and capital expenditure

The cash outflow from operating activities was TSEK 39,950 compared to TSEK 38,586 in the first quarter previous year. The difference compared to last year is primarily explained by higher interest paid, which was compensated to some extent, however, by lower personnel costs, see above.

The cash outflow from investing activities was TSEK 2,651 compared to TSEK 1,972 in the first quarter previous year. Investments in the quarter comprised investments in intangible assets of TSEK 2,521 compared to TSEK 1,680 in the first quarter previous year and consisted of capitalized development costs of TSEK 2,204 compared to TSEK 1,680 in the first quarter previous year and of patents of TSEK 317 compared to TSEK 0 in the first quarter previous year. Investments in property plant and equipment were TSEK 130 compared to TSEK 292 in the first quarter previous year.

Cash inflow from financing activities amounted to TSEK 143,005 compared to TSEK 37,327 in the first quarter previous year. Of the new share issue carried out in July, TSEK 152,045 had been received at July 31 and of the issue expenses that arose TSEK 539 had been paid. Convertible debt instruments of TSEK 42,000 matured during the quarter and were replaced at maturity by non-negotiable promissory notes. Of these TSEK 9,500 were repaid during the quarter. One further new loan of TSEK 1,000 was taken, see below.

Financing

Oasmia has a loan of TSEK 102,419 from Nexttobe AB, which up until October 31, 2016 was Oasmia's second largest shareholder. This loan carries interest of 3.5 percent and matures on September 30, 2017. The company is in the process of renewing or replacing this loan and estimates that this, apart from any interest, will not be charged to the company's cash flow over the next 12 months.

In April 2017, 26 convertible debt instruments were issued at a price of SEK 1,000,000 each, in total TSEK 26,000. These convertible debt instruments mature on April 18, 2018, unless there is prior conversion, and carry interest of 8.5 percent. These convertibles can be converted at a price of SEK 8.00 per share. Full conversion would entail the issue of 3,250,000 new shares.

Relative to a bond loan, convertible debt instruments provide both the right to receive interest and the opportunity to receive a certain number of shares instead of repayment of the loan. This additional benefit means that the interest rate of the convertible debt instruments is lower than the market interest rate for an equivalent bond loan. The fair value of the benefit Oasmia received due to the lower interest rate is recorded, after a deduction for issue expenses, directly against equity. The debt component of the convertibles, i.e. excluding the equity component indicated above, is recorded after a deduction for issue expenses at its fair value as a liability in the balance sheet the first time it is recorded. The interest expense is calculated thereafter according to the effective interest method and is charged to the income statement.

In June 2017 convertible debt instruments of TSEK 42,000 matured, and upon maturity were replaced by non-negotiable promissory notes. Of these promissory notes, TSEK 9,500 was repaid later on in the quarter at the same time as a new promissory note of TSEK 1,000 was issued. At July 31, there were non-negotiable promissory notes of TSEK 33,500 in total carrying 8.5 percent interest and maturing on June 30, 2018.

In July 2017 a rights issue was carried out, whereby 50,439,266 shares were issued at a price of SEK 3.25 kronor per share, which generated new equity of TSEK 163,928, minus issue expenses. Of the new shares 46,782,942 had been paid for at July 31, in total TSEK 152,045. Issue expenses of TSEK 15,665 arose in connection with the new share issue.

During the quarter 4,418,812 warrants were issued to the Board and management team at SEK 0.22 per warrant, which generated increased equity of TSEK 972 for Oasmia.

Outstanding warrants

As of July 31, 2017, the number of outstanding instruments was as follows:

Number of war
rants and con
vertibles
Maximum num
ber of shares
Warrants which can be converted to three shares
Warrants which can be converted to one share, Board
1,280,750 3,842,250
and management 4,418,182 4,418,182
Warrants which can be converted to one share, others 140,352 140,352
Convertibles 26 3,250,000
Maximum number of shares 11,650,784

These instruments do not entail any dilution effect as of July 31, 2017, but may do so in the future.

Financial position

The consolidated liquid assets at the end of the quarter totalled TSEK 128,406 compared to TSEK 22,987 in the first quarter previous year. The company has TSEK 0 invested in short-term interest funds compared to TSEK 20,029 in the first quarter previous year, of which TSEK 0 is frozen as security for a bank loan compared to TSEK 20,000 in the first quarter previous year. Interest-bearing liabilities were TSEK 160,806 and consist of a loan from Nexttobe, convertible debt instruments and non-negotiable promissory notes. The corresponding amount the previous year was TSEK 176,829 and consisted of a loan from Nexttobe, bank loans and convertible debt instruments.

Unutilized bank credit facilities at the end of the quarter amounted to TSEK 5,000 with a bank compared to TSEK 5,000 in the first quarter previous year and TSEK 40,000 with the principal owner Alceco International S.A. compared to TSEK 40,000 in the first quarter previous year

At the end of the quarter equity amounted to TSEK 406,007 compared to TSEK 289,584 in the first quarter previous year, the equity/assets ratio was 65% compared to 56% in the first quarter previous year and the net debt/equity ratio was 8% compared to 46 % in the first quarter previous year.

Future financing

Oasmia has two products approved, but this does not allow the company's business operations to generate sufficient cash flow. Work is therefore continuously conducted on finding other financing alternatives. This works includes the company engaging in discussions with potential collaboration partners about the licensing of distribution and sales rights, negotiations with new and existing investors, financiers and lenders, and the company securing resources so that future forecast revenue flows materialize in regions where the company's products are registered.

The Group's available cash and cash equivalents and unutilized credit facilities at July 31, 2017 do not provide the liquidity necessary to run the planned business operations in the coming 12 months. In the light of the ongoing work on possible financing alternatives and the recent development of the company, it is the Board's assessment that the outlook is good for financing the company's business operations during the coming year. If sufficient financing is not obtained, there is a risk that it may not be possible to continue operations.

Parent Company

The Parent Company's net sales for the quarter amounted to TSEK 20 compared to TSEK 36 in the first quarter previous year and the net loss before tax was TSEK 31,424 compared to TSEK 36,870 in the first quarter previous year. The Parent Company's cash and bank balances at the end of the quarter amounted to TSEK 127,285 compared to TSEK 22,868 in the first quarter previous year and short-term investments amounted to TSEK 0 compared to TSEK 20,029 in the first quarter previous year.

Key ratios and other information

2017 2016 2016/17
May-Jul May-Jul May-Apr
Number of shares at the end of the period, before and after dilution, in
thousands*
Weighted average number of shares, before and after dilution, in
172,881 109,353 128,620
thousands* 136,675 109,353 115,254
Earnings (loss) per share, before and after dilution, SEK* (0.23) (0.33) (1.39)
Equity per share, SEK* 2.35 2.65 2.33
Equity/assets ratio, % 65 56 58
Net liability, TSEK 32,400 133,813 140,724
Net debt/equity ratio, % 8 46 47
Return on total assets, % neg neg neg
Return on equity, % neg neg neg
Number of employees at the end of the quarter 61 77 66

* Recalculation of historical values has been made taking into account capitalization issue elements in the rights issue carried out in July 2017.

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 borrowings (comprising the balance sheet items liabilities to credit institutions, convertible debt instruments and other borrowings) 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 before taxes as a ratio of average equity.

The key ratios found above are generic key ratios often used in analyses and comparisons between different companies. They are therefore given to enable the reader to rapidly and summarily evaluate Oasmia's financial situation and possibly compare with other companies.

Consolidated income statement

2017 2016 2016/17
Note May-Jul May-Jul May-Apr
20 36 172
(8) 378 (1,405)
2,204 1,680 7,023
34 209 420
(327) (266) (2,984)
(16,543) (17,925) (79,904)
(12,684) (15,315) (59,295)
(1,116) (1,141) (4,508)
(28,421) (32,343) (140,481)
28 26 85
(3,320) (4,604) (19,847)
(3,292) (4,579) (19,762)
(31,713) (36,921) (160,243)
2 - - -
(31,713) (36,921) (160,243)
(160,243)
(1.39)
(31,713)
(0.23)
(36,921)
(0.33)

Consolidated statement of comprehensive income

2017 2016 2016/17
TSEK Note May-Jul May-Jul May-Apr
Income (loss) for the period (31,713) (36,921) (160,243)
Other comprehensive income (loss)
Items that may be subsequently reclassified to the income statement:
Translation differences (2) 9 13
Total other comprehensive income (loss) (2) 9 13
Comprehensive income (loss) for the period (31,715) (36,912) (160,230)
Comprehensive income (loss) attributable to:
Parent Company shareholders (31,715) (36,912) (160,230)
Comprehensive earnings (loss) per share, before and after dilution,
SEK *
(0.23) (0.33) (1.39)

* Recalculation of historical values has been made taking into account capitalization issue elements in the rights issue carried out in July 2017.

Consolidated statement of financial position

TSEK Note Jul 31, 2017 Jul 31, 2016 Apr 30, 2017
ASSETS
Non-current assets
Property, plant and equipment 17,685 20,619 18,368
Capitalized development costs 3 419,126 411,580 416,922
Other intangible assets 36,185 11,641 36,171
Financial non-current assets 2 2 2
Total non-current assets 472,998 443,842 471,464
Current assets
Inventories 4 13,450 16,918 13,685
Accounts receivable - 5,078 35
Other current receivables 1,859 2,794 1,390
Prepaid expenses and accrued income 6,212 5,226 7,008
Short-term investments 5 - 20,029 -
Cash and cash equivalents 128,406 22,987 28,001
Total current assets 149,927 73,031 50,119
TOTAL ASSETS 622,925 516,872 521,583
EQUITY
Capital and reserves attributable to Parent Company shareholders
Share capital 17,288 10,721 11,904
Non-registered share capital 366 - 706
Other capital provided 1,206,927 942,403 1,074,619
Reserves (7) (9) (6)
Retained earnings including income (loss) for the period (818,566) (663,531) (786,853)
Total equity 406,007 289,584 300,371
LIABILITIES
Current liabilities
Liabilities to credit institutions - 20,000 -
Convertible debt instruments 24,887 62 ,434 66,307
Other short-term borrowings 135,919 94,395 102,419
Accounts payable 19,147 22,855 20,837
Other current liabilities 16,154 2,571 5,356
Accrued expenses and deferred income 20,812 25,034 26,294
Total current liabilities 216,918 227,288 221,212
Total liabilities 216,918 227,288 221,212
TOTAL EQUITY AND LIABILITIES 622,925 516,872 521,583

Any contingent liabilities and pledged assets are reported in note 7

Consolidated statement of changes in equity

Attributable to Parent Company shareholders
TSEK Share capital Non-regis
tered share
capital
Other capital
provided
Reserves Retained earn
ings incl. in
come (loss) for
the period
Total equity
Opening balance as of May 1, 2016 10,721 0 941,961 (19) (626,610) 326,052
Income (loss) for the period - - - - (36,921) (36,921)
Other comprehensive income (loss) - - - 9 - 9
Comprehensive income (loss) for the pe
riod 0 0 0 9 (36,921) (36,912)
Equity component in issue of convertible debt
instruments - - 442 - - 442
Closing balance as of July 31, 2016 10,721 0 942,403 (9) (663,531) 289,584
Opening balance as of May 1, 2016 10,721 0 941,961 (19) (626,610) 326,052
Income (loss) for the year - - - - (160,243) (160,243)
Other comprehensive income (loss) - - - 13 - 13
Comprehensive income (loss) for the year
Equity component in issue of convertible debt
0 0 0 13 (160,243) (160,230)
instruments - - 1,152 - - 1,152
New share issues 1,183 706 135,111 - - 137,000
Issue expenses - - (3,605) - - (3,605)
Closing balance as of April 30, 2017 11,904 706 1,074,619 (6) (786,853) 300,371
Opening balance as of May 1, 2017 11,904 706 1,074,619 (6) (786,853) 300,371
Income (loss) for the period - - - - (31,713) (31,713)
Other comprehensive income (loss) - - - (2) - (2)
Comprehensive income (loss) for the pe
riod 0 0 0 (2) (31,713) (31,715)
Warrants - - 972 - - 972
New share issues 5,384 (340) 147,001 - - 152,045
Issue expenses - - (15,665) - - (15,665)
Closing balance as of July 31, 2017 17,288 366 1,206,927 (8) (818,566) 406,007

Consolidated cash flow statement

2017 2016 2016/17
TSEK Note May-Jul May-Jul May-Apr
Operating activities
Operating income (loss) before financial items (28,421) (32,343) (140,481)
Adjustments for non-cash items 1,116 1,141 15,310
Interest received 28 3 92
Interest paid (4,026) (138) (2,515)
Cash flow from operating activities before working
capital changes (31,302) (31,337) (127,595)
Change in working capital
Change in inventories 235 (280) (2,783)
Change in accounts receivable 35 (175) (198)
Change in other current receivables 328 (3,205) (3,584)
Change in accounts payable (2,385) (4,381) (6,616)
Change in other current liabilities (6,860) 792 7,764
Cash flow from operating activities (39,950) (38,586) (133,011)
Investing activities
Investments in intangible assets (2,521) (1,680) (7,445)
Investments in property, plant and equipment (130) (292) (516)
Disposal of short-term investments 5 - - 20,000
Cash flow from investing activities (2,651) (1,972) 12,038
Financing activities
Reduction of liabilities to credit institutions - - (20,000)
Borrowings 1,000 - -
Repayments of loans (9,500) - -
Convertible debt instruments - 42,000 84,000
Repayment of convertible debt instruments - - (2,000)
New share issues 152,045 - 70,000
Issue expenses (539) (4,673) (9,245)
Cash flow from financing activities 143,005 37,327 122,755
Cash flow for the period 100,405 (3,231) 1,782
Exchange rate differences in cash & cash equiva
lents 0 10 10
Cash and cash equivalents at beginning of the pe
riod
28,001 26,208 26,208
Cash and cash equivalents at end of the period 128,406 22,987 28,001

Parent Company income statement

2017 2016 2016/17
TSEK Note May-Jul May-Jul May-Apr
Net sales 20 36 172
Change in inventories of products in progress and fin
ished goods (8) 378 (1,405)
Capitalized development costs 2,204 1,680 7,023
Other operating income 34 209 420
Raw materials and consumables (327) (266) (2,984)
Other external expenses (15,997) (17,873) (79,669)
Employee benefit expenses (12,684) (15,314) (59,295)
Depreciation/amortization and impairment of property,
plant, equipment and intangible assets (1,116) (1,141) (4,508)
Operating income (loss) (27,874) (32,291) (140,246)
Result from participations in Group companies (257) - (65)
Other interest income and similar income 28 25 85
Interest expenses and similar expenses (3,320) (4,604) (19,847)
Financial items, net (3,549) (4,579) (19,827)
Income (loss) before taxes (31,424) (36,870) (160,073)
Income taxes 2 - - -
Income (loss) for the period (31,424) (36,870) (160,073

Parent Company balance sheet

TSEK Note Jul 31, 2017 Jul 31, 2016 Apr 30, 2017
ASSETS
Subscribed capital unpaid 11,883 - -
Non-current assets
Intangible non-current assets
Capitalized development costs 3 419,126 411,580 416,922
Concessions, patents, licences, trademarks
and similar rights
36,185 11,640 36,171
Property, plant and equipment
Equipment, tools, fixtures and fittings 17,539 20,519 18,222
Construction in progress and advance payments
for property, plant and equipment
146 100 146
Financial non-current assets
Participations in Group companies 1,481 110 110
Other securities held as non-current assets 1 1 1
Total non-current assets 474,478 443,950 471,573
Current assets
Inventories etc 4
Raw materials and consumables 5,354 7,031 5,581
Products in progress 8,096 4,515 8,104
Finished products - 5,372 -
13,450 16,918 13,685
Current receivables
Accounts receivable - 5,078 35
Receivables from Group companies 163 - -
Other current receivables 1,830 2,792 1,388
Prepaid expenses and accrued income 6,497 5,220 7,008
8,490 13,090 8,431
Short-term investments 5 - 20,029 -
Cash and bank balances 127,285 22,868 26,312
Total current assets 149,226 72,905 48,428
TOTAL ASSETS 635,587 516,855 520,001
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 17,288 10,721 11,904
Non-registered share capital 366 - 706
Statutory reserve 4,620 4,620 4,620
Reserve for development costs 9,986 1,680 7,783
32,260 17,021 25,013
Non-restricted equity
Share premium reserve 1,219,323 942,403 1,074,619
Retained earnings (801,654) (633,274) (639,378)
Net income (loss) for the period (31,424) (36,870) (160,073)
386,245 272,259 275,168
Total equity 418,505 289,280 300,181
Current liabilities
Liabilities to credit institutions - 20,000 -
Convertible debt instruments 24,887 62,434 66,307
Other short-term borrowings 135,919 94,395 102,419
Accounts payable 19,147 22,854 20,837
Liabilities to Group companies 1 644 287 1,664
Other current liabilities 14,674 2,571 2,303
Accrued expenses and deferred income 20,811 25,034 26,290
Total current liabilities 217,082 227,575 219,820
TOTAL EQUITY AND LIABILITIES 635,587 516,855 520,001

Any contingent liabilities and pledged assets are reported in note 7

Parent Company changes in equity

Restricted equity
Non-restricted equity
TSEK Share capi
tal
Non-registered
share capital
Statutory
reserve
Reserve for
development
costs
Share pre
mium reserve
Retained
earnings
Total equity
Opening balance as of May 1, 2016 10,721 - 4,620 - 941,961 (631,594) 325,707
Equity component in issue of convertible
debt instruments
Adjustment of non-restricted and re
- - - - 442 - 442
stricted equity - - - 1,680 - (1,680) 0
Income (loss) for the period - - - - - (36,870) (36,870)
Closing balance as of July 31, 2016 10,721 - 4,620 1,680 942,403 (670,144) 289,280
Opening balance as of May 1, 2016
Equity component in issue of convertible
10,721 - 4,620 - 941,961 (631,594) 325,707
debt instruments
Adjustment of non-restricted and re
- - - - 1,152 - 1,152
stricted equity - - - 7,783 - (7,783) 0
New share issue 1,183 706 - - 135,111 - 137,000
Issue expenses - - - - (3,605) - (3,605)
Income (loss) for the year - - - - - (160,073) (160,073)
Closing balance as of April 30, 2017 11,904 706 4,620 7,783 1,074,619 (799,450) 300,181
Opening balance as of May 1, 2017
Warrants
11,904
-
706
-
4,620
-
7,783
-
1,074,619
1,485
(799,450)
-
300,181
1,485
Adjustment of non-restricted and re
stricted equity
- - - 2,203 - (2,203) 0
New share issues 5,384 (340) - - 158,885 - 163,929
Issue expenses - - - - (15,665) - (15,665)
Income (loss) for the period - - - - - (31,424) (31,424)
Closing balance as of July 31, 2017 17,288 366 4,620 9,986 1,219,323 (833,078) 418,505

Note 1 Accounting policies etc

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 accounting policies and calculation methods are unchanged compared to those described in the Annual Report for the financial year May 1, 2016 – April 30, 2017.

The Parent Company accounts are established in accordance with RFR 2, Accounting for legal entities and the Swedish Annual Accounts Act.

New or revised IFRS standards or interpretations by IFRIC that have become effective since May 1, 2017 have not had any effect on Oasmia's financial reports. Similar to what was the case at the end of the previous financial year, financial instruments' carrying amounts are the same as fair values with the exception of the loan from Nexttobe and the convertible debt instruments. The fair values for these amount to TSEK 103,372 and TSEK 26,327 respectively. The Group currently has only one operating segment and therefore does not disclose any segment information.

Note 2 Taxes

The Group has accumulated losses carried forward, related to previous financial years and this financial year, amounting to TSEK 925,092 compared to TSEK 760,273 in the first quarter previous year and the Parent Company has TSEK 914,400 compared to TSEK 750,053 in the first quarter previous year. There are currently no sufficiently convincing reasons to assume that 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 costs

Oasmia capitalizes development costs 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.

Jul 31, Jul 31, Apr 30,
TSEK 2017 2016 2016
Paclical 309,851 301,637 307,647
Paccal Vet 109,275 109,943 109,275
Total 419,126 411,580 416,922

Note 4 Inventories

TSEK Jul 31,
2017
Jul 31,
2016
Apr 30,
2016
Acquisition value
Raw materials and consuma
bles 5,354 7,031 5,581
Products in progress 8,096 4,515 8,104
Finished products - 5,372 -
Total 13,450 16,918 13,685

Goods have been expensed or written down as follows:

2017 2016 2016/17
TSEK May-Jul May-Jul May-Apr
Goods expensed - - -
Goods written down - - 5,736

Note 5 Short-term investments

Liquid assets not utilized in daily operations have been invested in interest funds that invest in safe interest bearing securities and other fixed income instruments. As most securities included in these funds have a remaining maturity exceeding 3 months, these have been recorded as Short(term investments in the balance sheet and have been valued at fair value.

As of July 31, 2017, no short-term investments existed.

Note 6 Transactions with related parties

At July 31, 2017, Oasmia had a credit facility of TSEK 40,000, compared to TSEK 40,000 in the first quarter previous year, provided by one of the company's largest shareholders, Alceco International S.A. The interest rate on utilized credit is 5 percent. As of July 31, 2017, it was completely unutilized, which was also the case as of July 31, 2016.

Ardenia Investment Ltd, which is equally controlled by Oasmia's founders Bo Cederstrand and Julian Aleksov, is registered as the applicant for and the holder of the underlying patents for Oasmia's business. Pursuant to an agreement between Ardenia and Oasmia, the rights to these patents have been transferred to Oasmia. Ardenia re-charged Oasmia for administrative expenses for these patents during the quarter. The amount invoiced was TSEK 166 compared to TSEK 0 in the first quarter previous year.

During the quarter a shareholders' contribution was provided to the wholly owned subsidiary Oasmia Incentive AB (formerly Oasmia Animal Health AB). This comprised 4,418,182 warrants with a total carrying amount of TSEK 972. These warrants have been sold by Oasmia Incentive AB to Oasmia Pharmaceutical AB's Board and management in accordance with the resolution adopted at an Extraordinary General Meeting on June 2, 2017 regarding the issue of warrants.

No other material transactions with related parties occurred during the quarter beyond remuneration provided to members of the Board and employees.

Note 7 Contingent liabilities and pledged assets

The Parent Company has made a floating charge of TSEK 8,000 to a bank as security for an overdraft facility of TSEK 5,000, and as the limit for a foreign currency derivative of TSEK 3,000.

During the financial year 2016/17 warrants were issued in programmes for the Board and management. As these were invalid, however, an Extraordinary General Meeting on June 2, 2017 adopted a resolution whereby these programmes were cancelled. A possible consequence of the programmes being invalid and cancelled could be that the company's income statement is negatively impacted. However, it is difficult to estimate or determine the sum total of this eventuality. This disclosure is therefore made without specifying any impact on the income statement.

The Parent Company has given a guarantee to a former employee regarding any costs stemming from employment at Oasmia that might later affect the employee.

A claim has been filed against Oasmia by one of its suppliers which the company has contested in its entirety. It is difficult to evaluate a likely outcome or cost as a result of the claim. The best assessment of the Board and management is that the company might be impacted by a cost amounting to approximately MSEK 10 in the event of a negative outcome of a potential legal dispute.

Note 8 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 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 financial year May 1, 2016 – April 30, 2017. No further risks have occurred during the period.

Note 9 Future financing

Oasmia has two products approved, but this does not allow the company's business operations to generate sufficient cash flow. Work is therefore continuously conducted on finding other financing alternatives. This works includes the company engaging in discussions with potential collaboration partners about the licensing of distribution and sales rights, negotiations with new and existing investors, financiers and lenders, and the company securing resources so that future forecast revenue flows materialize in regions where the company's products are registered.

The Group's available cash and cash equivalents and unutilized credit facilities at July 31, 2017 do not provide the liquidity necessary to run the planned business operations in the coming 12 months. In the light of the ongoing work on possible financing alternatives and the recent development of the company, it is the Board's assessment that the outlook is good for financing the company's business operations during the coming year. If sufficient financing is not obtained, there is a risk that it may not be possible to continue operations.

The Board of Directors and the CEO of Oasmia Pharmaceutical AB certify that this interim report gives a fair view of the Parent Company's and Group's activities, position and results and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group face.

Uppsala, September 1, 2017

Julian Aleksov, Executive Chairman Bo Cederstrand, Member of the Board

Alexander Kotsinas, Member of the Board Lars Bergkvist, Member of the Board

Mikael Asp, CEO

This information is information that Oasmia Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Market Act. The information was submitted for publication, through the agency of the contact person set out below, at 08:15 CET on September 1, 2017.

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 the subject of review by the company's auditors.

Annual General Meeting

The Annual General Meeting will be held on September 25, 2017 in the company offices in Uppsala. A notice for the Meeting was distributed on Friday August 25th , which was within four weeks before the Meeting. For more information, see the company website www.oasmia.com

_________________________________________________________________________________

COMPANY INFORMATION

Oasmia Pharmaceutical AB (publ) Corp. reg. no. 556332-6676 Domicile: Stockholm

Address and telephone number of the main office Vallongatan 1, 752 28 UPPSALA, SWEDEN Phone: +46 18-50 54 40, www.oasmia.com, E-mail: [email protected]

Questions concerning this report should be addressed to: Mikael Asp, CEO, Phone: +46 18-50 54 40, E-mail: [email protected]

FUTURE REPORT DATES

Interim report May – October 2017 December 1, 2017 Interim report May 2017 – January 2018 March 2, 2018 Year-end report May 2017 – April 2018 June 8, 2018 Interim report May – July 2018 August 31, 2018 Interim report May – October 2018 November 30, 2018

Key figures in USD (additional information)

Solely for the convenience of the reader, some key figures have been translated into USD as additional information for shareholders in the U.S. It is not the official report in the functional currency of Oasmia, which is SEK. Swedish krona have been translated into U.S. dollars at the closing rate as per July 31, 2017 which was 8.0752 SEK per one USD (source: Federal Reserve Bank of New York). This rate has been used for conversion of currency for all figures including those from previous periods.

2017 2016 2016/17
\$ 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 di
lution, in thousands 172,881 109,353 128,620
Weighted average number of shares, before and after dilution,
in thousands
136,675 109,353 115,254
Earnings (loss) per share, before and after dilution, in \$ (0.03) (0.04) (0.17)
Equity per share, \$ 0.29 0.33 0.29
Equity/Assets ratio, % 65 56 58
Net debt 4,012 16,571 17,427
Net debt/Equity ratio, % 8 46 47
Number of employees at the end of the period 61 77 66
Consolidated income statement in brief
Net sales 2 4 21
Capitalized development cost 273 208 870
Operating income (loss) (3,519) (4,005) (17,397)
Financial income and expenses - net (408) (567) (2,447)
Income (loss) before taxes (3,927) (4,572) (19,844)
Income (loss) for the period (3,927) (4,572) (19,844)
Comprehensive income (loss) for the period (3,927) (4,571) (19,842)
Consolidated statement of financial position in brief
Total non-current assets 58,574 54,964 58,384
Total current assets 18,566 9,044 6,207
Total assets 77,141 64,007 64,591
Total equity 50,278 35,861 37,197
Total current liabilities 26,862 28,146 27,394
Total liabilities 26,862 28,146 27,394
Total equity and liabilities 77,141 64,007 64,591
Consolidated cash flow statement in brief
Operating income (loss) before financial items (3,519) (4,005) (17,397)
Cash flow from operating activities before changes in working
capital
(3,876) (3,881) (15,801)
Cash flow from operating activities (4,947) (4,778) (16,472)
Cash flow from investing activities (328) (244) 1,491
Cash flow from financing activities 17,709 4,622 15,202
Cash flow for the period 12,434 (400) 221
Cash and cash equivalents at end of the period 15,901 2,847 3,468

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, 2017 which was 9.5408 SEK per one EUR. (source: Swedish Central Bank).

2017 2016 2016/17
€ 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
172,881 109,353 128,620
Weighted average number of shares, before and after dilu
tion, in thousands 136,675 109,353 115,254
Earnings (loss) per share, before and after dilution, in € (0.02) (0.03) (0.15)
Equity per share, € 0.25 0.28 0.24
Equity/Assets ratio, % 65 56 58
Net debt 3,396 14,025 14,750
Net debt/Equity ratio, % 8 46 47
Number of employees at the end of the period 61 77 66
Consolidated income statement in brief
Net sales 2 4 18
Capitalized development cost 231 176 736
Operating income (loss) (2,979) (3,390) (14,724)
Financial income and expenses - net (345) (480) (2,071)
Income (loss) before taxes (3,324) (3,870) (16,796)
Income (loss) for the period (3,324) (3,870) (16,796)
Comprehensive income (loss) for the period (3,324) (3,869) (16,794)
Consolidated statement of financial position in brief
Total non-current assets 49,576 46,520 49,416
Total current assets 15,714 7,655 5,253
Total assets 65,291 54,175 54,669
Total equity 42,555 30,352 31,483
Total current liabilities 22,736 23,823 23,186
Total liabilities 22,736 23,823 23,186
Total equity and liabilities 65,291 54,175 54,669
Consolidated cash flow statement in brief
Operating income (loss) before financial items (2,979) (3,390) (14,724)
Cash flow from operating activities before changes in working
capital
(3,281) (3,285) (13,374)
Cash flow from operating activities (4,187) (4,044) (13,941)
Cash flow from investing activities (278) (207) 1,262
Cash flow from financing activities 14,989 3,912 12,866
Cash flow for the period 10,524 (339) 187
Cash and cash equivalents at end of the period 13,459 2,409 2,935