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Vivesto — Interim / Quarterly Report 2014
Mar 6, 2014
3124_10-q_2014-03-06_3330844a-75c0-4691-9471-d9d338af76a4.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for the period May 2013 - January 2014 €
Page 1-10 is a service to shareholders in the euro zone. It is not the official report in the functional currency of Oasmia, which is SEK, but the first ten pages of that report converted to EUR. The full official report will be found on pages 11-24. 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 January 31, 2014 which was 8.8466 SEK per one EUR. When occasional figures are in SEK or USD it is because the amount is very firmly denominated in that currency.
CONTINUED DEVELOPMENT OF THE PRE-CLINICAL AND CLINICAL RESEARCH PROGRAM
THIRD QUARTER November 1, 2013 – January 31, 2014
- Consolidated Net sales amounted to € 2 thousand (0) 1
- Operating income amounted to € 3,221 thousand (-1,628)
- Net income after tax amounted to € 3,440 thousand (-1,757)
- Earnings per share amounted to € 0.04 (-0.02)
- Comprehensive income amounted to € 3,440 thousand (-1,757)
- FDA approved Oasmia's production facility in Uppsala
- Increased financing by extension of the MSEK 105 loan from Nexttobe AB and a new MSEK 40 bank loan.
THE PERIOD May 1, 2013 – January 31, 2014
- Consolidated Net sales amounted to € 5 thousand (0)
- Operating income amounted to € -7,105 thousand (-5,162)
- Net income after tax amounted to € -7,610 thousand (-5,587)
- Earnings per share amounted to € -0.09 (-0.09)
- Comprehensive income amounted to € -7,610 thousand (-5,587)
- Oasmia initiated a clinical program for Paclical for treatment of breast cancer
- Oasmia initiated pre-clinical studies with OAS-19, the first pharmaceutical project with a combination of two active cytostatics in one infusion
The numbers in brackets concern results from the corresponding period of the previous year
EVENTS AFTER CLOSING DAY
• Oasmia is granted conditional FDA approval for Paccal Vet
CEO COMMENTS:
"We have continued the planning of new clinical programs in the period, among others a Phase I study with Doxophos for treatment of breast cancer and a Phase II study with Doxophos Vet for treatment of lymphoma in dogs. Simultaneously, the preparations for the launch of Paccal Vet and Paclical have continued. The approval of our production facility was a large step forward for Oasmia", says Oasmia's CEO Julian Aleksov.
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
HUMAN HEALTH
Oasmia's research and development in human health is mainly focused on the common indications ovarian cancer and breast cancer.
Paclical®
Paclical® is a patented formulation of paclitaxel, in combination with Oasmia's patented technology XR-17. Paclical® is designated as an orphan drug (see below) in EU and USA for the indication ovarian cancer.
Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer, an indication with 225,000 annual new cases globally. The total number of patients in the study is 789, and the final patient was treated in the beginning of 2013. All patients have been followed up regarding time to progression. Oasmia is now evaluating the results, which will be used for submission of marketing authorization applications for Paclical® in the EU, the US and the rest of the world.
In September 2012, Oasmia submitted an application for market authorization for Paclical® in Russia, which is currently being processed by the Russian pharmaceutical authorities.
Oasmia started a dose finding study with Paclical for weekly treatment of breast cancer in the summer of 2013.
Doxophos®
Doxophos® is a patented formulation of doxorubicin in combination with XR-17. Doxorubicin is one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation for this product candidate and is now planning a clinical Phase I study.
Docecal®
Docecal® is a patented formulation of the cytostatic docetaxel in combination with XR-17. Oasmia has initiated the validation process for manufacture of Docecal®, and is preparing a clinical Phase I study for treatment of breast cancer.
OAS-19
OAS-19 is the first oncology product candidate to apply a dual cytostatic agent encapsulation and release mechanism in one infusion. It is the unique properties in XR-17 that make this combination possible. This concept provides Oasmia with another dimension for pharmaceutical development of multiple active substances in one
micelle where also substances with different solubility can be combined. Recent pre-clinical studies have shown promising results, and the company plans to start clinical studies with OAS-19 in 2014.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE1 | PHASE II | PHASE III | REG./ | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paclical® (paclitaxel) |
Ovarian cancer | Ongoing | MAA and NDA filings planned |
Global (ex-RUS/CIS) |
oasmia | |||
| In Registration | RUS/CIS | SPHARMASYNTEZ | ||||||
| Metastatic breast cancer |
Ongoing | Global | oasmia | |||||
| Doxophos® (doxorubicin) |
Breast cancer | Planned | Global | oasmia | ||||
| Docecal® (docetaxel) |
Breast cancer | Ongoing | Global | oasmia | ||||
| OAS-19 (combination) |
Various cancers | Ongoing | Global | oasmia |
Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (USA) years on the indication, when the drug is approved for market.
ANIMAL HEALTH
Product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs. The company has two pharmaceutical candidates here.
Paccal® Vet
Paccal® Vet is a patented formulation of paclitaxel, in combination with XR-17. We are counting on that Paccal Vet will be the first injectable chemotherapeutic product marketed for treatment of solid tumours in dogs.
Oasmia has been granted MUMS designation (see below) by the American Food and Drug Administration (FDA) in the USA for Paccal Vet in treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma.
After the closing day, Oasmia was granted conditional approval of Paccal Vet for treatment of mammary carcinoma and squamous cell carcinoma.
The company is conducting a complementary study on Paccal Vet for treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs which has been treated 4 times with three week intervals. When data have been collected and analysed, Oasmia intends to file an application for market approval for Paccal® Vet to the European authority EMA. We are also considering an expansion of this study to apply for full approval in the USA.
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 cancer indications in dogs. Doxophos® Vet has been granted a MUMS designation (see below) in the USA for the indication lymphoma.
Oasmia conducts a Phase I study for Doxophos® Vet in order to establish the dose for the clinical program.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE I | PHASE II | PHASE III | REG./ | RIGHTS | |
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paccal ® Vet (paclitaxel) |
Mammary / squarrious cell |
Approved* | Global [ex-RUS/IAP] |
Abbott Animal Health |
||||
| Must cell | Ongoing | Global (ex-RUS/JAP) |
Abbott Animal Health |
|||||
| Doxophos® Vet (doxorubican) |
Lymphoma | Ongoing | Planned | Global | Abbott Animal Health |
|||
| *Conditionally by the FDA approved on 2014-02-28 |
BOLAGET MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
FDA approved Oasmia's production facility in Uppsala
In December 2013, Oasmia announced that the company's production facility in Uppsala had undergone a Pre-Approval Inspection by the FDA with a satisfactory result. FDA has thereby confirmed that Oasmia's manufacture of Paccal Vet meets the requirements for current Good Manufacturing Practice, cGMP.
Increased financing
In December 2013, the existing loan from Nexttobe AB amounting to MSEK 105 was extended by one year, from 2013-12-31 to 2014-12-31. The interest in 2014 is 8.5 % and it will be paid in its entirety on 2014-12-31. In addition, Oasmia was granted a new MSEK 40 bank loan in November 2013, which is due on 2014-03-31.
Warrants
A resolution was made at the Annual General Meeting 2013 to offer the company Board of Directors and management the right to subscribe for warrants in Oasmia Pharmaceutical AB. In October 2013, the maximum number of warrants were issued, 1 050 000, free from consideration, from the parent company to the subsidiary Oasmia Animal Health AB. The subsidiary has the right and obligation to transfer the warrants to the Board and management. For further details about terms, see the communiqué from the Annual General Meeting on the company website. As of January 2014, no acquisitions of warrants had been made.
Share price development during the period May 2013 – January 2014 (SEK)
EVENTS AFTER CLOSING DAY
Oasmia is granted FDA approval for Paccal Vet
On February 28, 2014, Oasmia announced that the American Food and Drug Administration (FDA) granted a conditional approval for the company's first pharmaceutical, Paccal Vet-CA1 and thereby provided veterinary oncologists with a new treatment option for squamous cell carcinoma and mammary carcinoma in dogs.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 2 | - | 5 | - | - |
| Capitalized development cost | 912 | 1,201 | 2,496 | 4,274 | 5,498 |
| Operating income | -3,221 | -1,628 | -7,105 | -5,162 | -7,639 |
| Net income after tax | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Earnings per share (€), before and after dilution* | -0.04 | -0.02 | -0.09 | -0.09 | -0.12 |
| Comprehensive income for the period | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
THIRD QUARTER November 1, 2013 – January 31, 2014
Net sales Net sales amounted to € 2 thousand (-).
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to € 912 thousand (1,201). The larger part concerned Paclical which was capitalized with € 654 thousand (1,084) and a smaller part concerning
Paccal Vet which contributed with € 259 thousand (117). The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials for Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment were significantly higher compared to the previous year and amounted to € 3,998 thousand (2,955). The nature of the operating expenses has changed. The costs for clinical trials have decreased somewhat, but costs related to preparations for the commercial phase Oasmia is planning for has increased more than the decrease in development costs. The latter refers to among other things method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
Income for the quarter
Net income was € -3,440 thousand (-1,757). The decrease between these two quarters was attributable to significantly increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III.
THE PERIOD May 1, 2013 – January 31, 2014
Net sales
Net sales amounted to € 5 thousand (-) and concerned sales of supplies.
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to € 2,496 thousand (4,274). The larger part concerned Paclical which was capitalized with € 1,633 thousand (4,131) and a smaller part concerning Paccal Vet which contributed with € 863 thousand (143). The decrease compared to the previous year is attributable to decreased costs for clinical trials for Paclical®.
Other operating income
Other operating income amounted to € 500 thousand (282) and mainly concerned an insurance compensation for a production disruption amounting to € 480 thousand.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to € 9,680 thousand (9,285). The nature of the operating expenses has changed. The costs for clinical trials have decreased, but costs related to preparations for the commercial phase Oasmia is planning for has increased more than the decrease in development costs. The latter refers to among other things method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
The number of employees at the end of the period was 78 (77).
Income for the period
Net income was € -7,610 thousand (-5,587). The decrease was to a lesser extent attributable to increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III compared to the corresponding period the previous year.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Cash flow and Capital expenditures
Cash flow from operating activities amounted to € -6,719 thousand (-5,776).
Cash flow from investing activities amounted to € -2,843 thousand (-5,526). The decreased level of investments concerned capitalized development costs and other intangible assets and property, plant and equipment.
Of these, investments in intangible assets amounted to € 2,814 thousand (5,514), consisting of capitalized development costs € 2,496 thousand (4,274) and patents and other intangible assets € 318 thousand (1,240).
Of these, only € 29 thousand (491) were investments in property, plant and equipment.
Financing
Financing in the period May – December 2013 was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012 and a € 480 thousand insurance compensation. Thereafter, the financing has been performed by a € 4,522 thousand bank loan.
Financial position
The consolidated liquid assets at the end of the period amounted to € 2,076 thousand (10,438). The interestbearing liabilities were € 16,390 thousand (11,868).
At the end of the period, unutilized credits with bank amounted to € 565 thousand (565) and with the principal owner Alceco International S.A € 4,522 thousand (4,522).
Equity at the end of the period amounted to € 28,466 thousand (38,675), the equity/assets ratio was 60 % (74 %) and the net debt/equity ratio was 50 % (4 %).
The parent company
The parent company´s net sales amounted to € 5 thousand (0) and net income before tax amounted to € -7,607 thousand (-5,588). The parent company's liquid assets at the end of the period amounted to € 2,076 thousand (10,437).
Key ratios and other information
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | |
|---|---|---|---|---|---|
| Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution* Weighted average number of shares (in thousands) before |
81,772 | 81,772 | 81,772 | 81,772 | 81,772 |
| and after dilution* | 81,772 | 76,651 | 81,772 | 64,359 | 68,605 |
| Earnings per share in €, before and after dilution* | -0.04 | -0.02 | -0.09 | -0.09 | -0.12 |
| Equity per share, €* | 0.35 | 0.47 | 0.35 | 0.47 | 0.44 |
| Equity/Assets ratio, % | 60 | 74 | 60 | 74 | 72 |
| Net debt, € thousand | 14,314 | 1,431 | 14,314 | 1,431 | 4,753 |
| Net debt/Equity ratio, % | 50 | 4 | 50 | 4 | 13 |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 78 | 77 | 78 | 77 | 75 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
Definitions
Earnings per share: The income for the period attributable to the shareholders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity divided by the number of shares at the end of the period
Equity/assets ratio: Equity as a percentage of the balance sheet total.
Net debt: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deduction for liquid funds
Net debt/Equity ratio: Net debt in relation to equity.
Return on total assets: Income before deduction of interest expenses in relation to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 2 | - | 5 | - | - |
| Capitalized development cost | 912 | 1,201 | 2,496 | 4,274 | 5,498 |
| Other operating income | 8 | 271 | 500 | 282 | 285 |
| Raw materials, consumables and goods for resale | -162 | -115 | -420 | -551 | -694 |
| Other external expenses | -2,488 | -1,545 | -5,443 | -5,227 | -7,350 |
| Employee benefit expenses | -1,349 | -1,295 | -3,816 | -3,506 | -4,794 |
| Depreciation/amortization and impairment | -145 | -144 | -425 | -432 | -575 |
| Other operating expenses | 0 | - | 0 | - | -10 |
| Operating income | -3,221 | -1,628 | -7,105 | -5,162 | -7,639 |
| Financial income | 1 | 35 | 17 | 35 | 66 |
| Financial expenses | -221 | -164 | -522 | -461 | -609 |
| Financial items, net | -220 | -129 | -505 | -425 | -542 |
| Income before taxes | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Taxes | - | - | - | - | - |
| Income for the period | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Income for the period attributable to: | |||||
| Shareholders of the Parent company | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Earnings per share, before and after dilution, € | -0.04 | -0.02 | -0.09 | -0.09 | -0.12 |
Consolidated Statement of comprehensive income
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | |
|---|---|---|---|---|---|
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Income for the period | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Comprehensive income for the period | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Comprehensive income for the period attributable to: | |||||
| Shareholders of the Parent company | -3,440 | -1,757 | -7,610 | -5,587 | -8,182 |
| Comprehensive Earnings per share, before and after dilution, € | -0.04 | -0.02 | -0.09 | -0.09 | -0.12 |
Consolidated statement of financial position
| € thousands | 2014-01-31 | 2013-01-31 | 2013-04-30 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 2,648 | 3,074 | 2,957 |
| Capitalized development cost | 40,796 | 37,076 | 38,300 |
| Other intangible assets | 1,395 | 1,191 | 1,164 |
| Financial assets | 0 | 0 | 0 |
| Total Non-current assets | 44,839 | 41,341 | 42,421 |
| Current assets | |||
| Inventories | 187 | 100 | 100 |
| Trade receivables | 7 | - | - |
| Other current receivables | 357 | 281 | 262 |
| Prepaid expenses and accrued income | 327 | 220 | 422 |
| Liquid assets | 2,076 | 10,438 | 7,116 |
| Total Current assets | 2,954 | 11,039 | 7,901 |
| TOTAL ASSETS | 47,793 | 52,380 | 50,322 |
| EQUITY | |||
| Capital and provisions attributable to shareholders of the Parent Company | |||
| Share capital | 924 | 924 | 924 |
| Other capital provided | 64,820 | 64,824 | 64,820 |
| Retained earnings | -37,278 | -27,074 | -29,668 |
| Total Equity | 28,466 | 38,675 | 36,076 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other non-current liabilities | 101 | 101 | 101 |
| Total Non-current liabilities | 101 | 101 | 101 |
| Current liabilities | |||
| Liabilities to credit institutions | 4,522 | - | - |
| Short-term borrowings | 11,869 | 11,869 | 11,869 |
| Trade payables | 815 | 501 | 801 |
| Other current liabilities | 164 | 178 | 177 |
| Accrued expenses and prepaid income | 1,857 | 1,057 | 1,298 |
| Total Current liabilities | 19,226 | 13,604 | 14,145 |
| Total Liabilities | 19,327 | 13,705 | 14,246 |
| TOTAL EQUITY AND LIABILITIES | 47,793 | 52,380 | 50,322 |
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company | ||||||||
|---|---|---|---|---|---|---|---|---|
| € thousands | Share capital | Other capital provided | Retained earnings | Total equity | ||||
| Opening balance as of May 1, 2012 | 647 | 51,752 | -21,486 | 30,913 | ||||
| Comprehensive income for the period | - | - | -5,587 | -5,587 | ||||
| New share issue | 277 | 13,588 | - | 13,865 | ||||
| Issue expenses | - | -516 | - | -516 | ||||
| Closing balance as of January 31, 2013 | 924 | 64,824 | -27,074 | 38,675 | ||||
| Opening balance as of May 1, 2012 | 647 | 51,752 | -21,486 | 30,913 | ||||
| Comprehensive income for the period | - | - | -8,182 | -8,182 | ||||
| New share issue | 277 | 13,588 | - | 13,865 | ||||
| Issue expenses | - | -520 | - | -520 | ||||
| Closing balance as of April 30, 2013 | 924 | 64,820 | -29,668 | 36,076 | ||||
| Opening balance as of May 1, 2013 | 924 | 64,820 | -29,668 | 36,076 | ||||
| Issue expenses | - | - | -7,610 | -7,610 | ||||
| Closing balance as of January 31, 2014 | 924 | 64,820 | -37,278 | 28,466 | ||||
| Consolidated Cash flow statement | ||||||||
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | ||||
| € thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April | |||
| Operating activities | ||||||||
| Operating income before financial items | -3,221 | -1,628 | -7,105 | -5,162 | -7,639 | |||
| Depreciation/amortization | 145 | 144 | 425 | 432 | 575 | |||
| Disposals of tangible and intangible assets | 0 | - | 0 | - | 10 | |||
| Adjustments for income from divestiture of intangible assets | - | -178 | - | -178 | -178 | |||
| Interest received | 1 | 35 | 17 | 35 | 66 | |||
| Interest paid | -5 | -14 | -8 | -66 | -69 | |||
| Cash flow from operating activities before working capital changes | -3,080 | -1,641 | -6,670 | -4,938 | -7,236 | |||
| Change in working capital | ||||||||
| Change in inventories | 22 | - | -87 | -68 | -68 | |||
| Change in trade receivables | -3 | - | -7 | - | - | |||
| Change in other current receivables | -60 | -5 | 0 | -59 | -242 | |||
| Change in trade payables | 357 | -289 | 14 | -661 | -361 | |||
| Change in other current liabilities | 74 | 93 | 31 | -50 | 46 | |||
| Cash flow from operating activities | -2,691 | -1,842 | -6,719 | -5,776 | -7,861 | |||
| Investing activities | ||||||||
| Investments in intangible fixed assets | -959 | -1,243 | -2,814 | -5,514 | -6,737 | |||
| Divestiture of intangible fixed assets | - | 479 | - | 479 | 479 | |||
| Investments in property, plant and equipment | -22 | -8 | -29 | -491 | -501 | |||
| Cash flow from investing activities | -981 | -772 | -2,843 | -5,526 | -6,759 | |||
| Financing activities | ||||||||
| Increase in liabilities to credit institutions | 4,522 | - | 4,522 | - | - | |||
| Decrease in liabilities to credit institutions | - | -526 | - | -361 | -361 | |||
| New share issue | - | 13,865 | - | 13,865 | 13,865 | |||
| Issue expenses | - | -516 | - | -516 | -520 | |||
| New loans | - | - | - | 9,043 | 9,043 | |||
| Repayment of loans | - | - | - | -520 | -520 | |||
| Cash flow from financing activities | 4,522 | 12,824 | 4,522 | 21,511 | 21,507 | |||
| Cash flow for the period | 850 | 10,210 | -5,040 | 10,208 | 6,887 | |||
| Cash and cash equivalents at the beginning of the period | 1,227 | 228 | 7,116 | 229 | 229 | |||
| Cash and cash equivalents at the end of the period | 2,076 | 10,438 | 2,076 | 10,438 | 7,116 |
Oasmia Pharmaceutical AB (publ)
Interim report for the period May 2013 - January 2014
CONTINUED DEVELOPMENT OF THE PRE-CLINICAL AND CLINICAL RESEARCH PROGRAM
THIRD QUARTER November 1, 2013 – January 31, 2014
- Consolidated Net sales amounted to TSEK 16 (0) 2
- Operating income amounted to TSEK -28 492 (-14 401)
- Net income after tax amounted to -30 436 (-15 540)
- Earnings per share amounted to SEK -0,37 (-0,20)
- Comprehensive income amounted to TSEK -30 436 (-15 540)
- FDA approved Oasmia's production facility in Uppsala
- Increased financing by extension of the MSEK 105 loan from Nexttobe AB and a new MSEK 40 bank loan.
THE PERIOD May 1, 2013 – January 31, 2014
- Consolidated Net sales amounted to TSEK 40 (0)
- Operating income amounted to TSEK -62 851 (-45 664)
- Net income after tax amounted to TSEK -67 321 (-49 428)
- Earnings per share amounted to SEK -0,82 (-0,77)
- Comprehensive income amounted to -67 321 (-49 428)
- Oasmia initiated a clinical program for Paclical for treatment of breast cancer
- Oasmia initiated pre-clinical studies with OAS-19, the first pharmaceutical project with a combination of two active cytostatics in one infusion
EVENTS AFTER CLOSING DAY
• Oasmia is granted conditional FDA approval for Paccal Vet
The numbers in brackets concern results from the corresponding period of the previous year
CEO COMMENTS:
"We have continued the planning of new clinical programs in the period, among others a Phase I study with Doxophos for treatment of breast cancer and a Phase II study with Doxophos Vet for treatment of lymphoma in dogs. Simultaneously, the preparations for the launch of Paccal Vet and Paclical have continued. The approval of our production facility was a large step forward for Oasmia", says Oasmia's CEO Julian Aleksov.
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company share is listed at NASDAQ OMX in Stockholm and at the Frankfurt Stock Exchange.
BUSINESS ACTIVITIES
HUMAN HEALTH
Oasmia's research and development in human health is mainly focused on the common indications ovarian cancer and breast cancer.
Paclical®
Paclical® is a patented formulation of paclitaxel, in combination with Oasmia's patented technology XR-17. Paclical® is designated as an orphan drug (see below) in EU and USA for the indication ovarian cancer.
Oasmia has performed a Phase III study with Paclical® for treatment of ovarian cancer, an indication with 225,000 annual new cases globally. The total number of patients in the study is 789, and the final patient was treated in the beginning of 2013. All patients have been followed up regarding time to progression. Oasmia is now evaluating the results, which will be used for submission of marketing authorization applications for Paclical® in the EU, the US and the rest of the world.
In September 2012, Oasmia submitted an application for market authorization for Paclical® in Russia, which is currently being processed by the Russian pharmaceutical authorities.
Oasmia started a dose finding study with Paclical for weekly treatment of breast cancer in the summer of 2013.
Doxophos®
Doxophos® is a patented formulation of doxorubicin in combination with XR-17. Doxorubicin is one of the most efficient and used substances for treatment of cancer. Oasmia has compiled documentation for this product candidate and is now planning a clinical Phase I study.
Docecal®
Docecal® is a patented formulation of the cytostatic docetaxel in combination with XR-17. Oasmia has initiated the validation process for manufacture of Docecal®, and is preparing a clinical Phase I study for treatment of breast cancer.
OAS-19
OAS-19 is the first oncology product candidate to apply a dual cytostatic agent encapsulation and release mechanism in one infusion. It is the unique properties in XR-17 that make this combination possible. This concept provides Oasmia with another dimension for pharmaceutical development of multiple active substances in one micelle where also substances with different solubility can be combined. Recent pre-clinical studies have shown promising results, and the company plans to start clinical studies with OAS-19 in 2014.
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE1 PHASE II PHASE III |
REG./ | RIGHTS | |||
|---|---|---|---|---|---|---|---|---|
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paclical® (paclitaxel) |
Ovarian cancer | Ongoing | MAA and NDA filings planned |
Global (ex-RUS/CIS) |
oasmia | |||
| In Registration | RUS/CIS | SPHARMASYNTEZ | ||||||
| Metastatic breast cancer |
Ongoing | Global | oasmia | |||||
| Doxophos® (doxorubicin) |
Breast cancer | Planned | Global | oasmia | ||||
| Docecal ® (docetaxel) |
Breast cancer | Ongoing | Global | oasmia | ||||
| OAS-19 (combination) |
Various cancers | Ongoing | Global | oasmia |
Orphan drug designation is granted for minor indications and entails market exclusivity for seven (EU) and ten (USA) years on the indication, when the drug is approved for market.
ANIMAL HEALTH
Product development within Animal Health is aimed at pharmaceuticals for the treatment of cancer in dogs. The company has two pharmaceutical candidates here.
Paccal® Vet
Paccal® Vet is a patented formulation of paclitaxel, in combination with XR-17. We are counting on that Paccal Vet will be the first injectable chemotherapeutic product marketed for treatment of solid tumours in dogs.
Oasmia has been granted MUMS designation (see below) by the American Food and Drug Administration (FDA) in the USA for Paccal Vet in treatment of mastocytoma, mammary carcinoma and squamous cell carcinoma.
After the closing day, Oasmia was granted conditional approval of Paccal Vet for treatment of mammary carcinoma and squamous cell carcinoma.
The company is conducting a complementary study on Paccal Vet for treatment of mastocytoma. The purpose of the study is to measure time to progression for dogs which has been treated 4 times with three week intervals. When data have been collected and analysed, Oasmia intends to file an application for market approval for Paccal® Vet to the European authority EMA. We are also considering an expansion of this study to apply for full approval in the USA.
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 cancer indications in dogs. Doxophos® Vet has been granted a MUMS designation (see below) in the USA for the indication lymphoma.
Oasmia conducts a Phase I study for Doxophos® Vet in order to establish the dose for the clinical program.
| Anımal Health | ||||||||
|---|---|---|---|---|---|---|---|---|
| CANDIDATE | INDICATION | PRE-CLINICAL | PHASE I | PHASE II | PHASE III | REG. | RIGHTS | |
| APPROVAL | GEOGRAPHY | PARTNER | ||||||
| Paccal ® Vet (paclitaxel) |
Mammary/ squarrious cell |
Approved* | Global $(ex-RUS/IAP)$ |
Abbott Animal Health |
||||
| Musicell | Ongoing | Global (ex-RUS/JAP) |
Abbott Animal Health |
|||||
| Doxophos® Vet (doxorubican) |
Lymphorna | Ongoing | Planned | Global | Abbott Animal Health |
BOLAGET MUMS designation (minor use/minor species) is granted by the FDA either for a small area of use within a common species such as dogs, or for treatment of a less common species. The most interesting aspect of MUMS is the eligibility to apply for conditional market approval with seven years market exclusivity. Conditional market approval enables the manufacturer to make the product available before all necessary efficacy data have been obtained. However, safety data must prove that the product is safe.
THE COMPANY
FDA approved Oasmia's production facility in Uppsala
In December 2013, Oasmia announced that the company's production facility in Uppsala had undergone a Pre-Approval Inspection by the FDA with a satisfactory result. FDA has thereby confirmed that Oasmia's manufacture of Paccal Vet meets the requirements for current Good Manufacturing Practice, cGMP.
Increased financing
In December 2013, the existing loan from Nexttobe AB amounting to MSEK 105 was extended by one year, from 2013-12-31 to 2014-12-31. The interest in 2014 is 8.5 % and it will be paid in its entirety on 2014-12-31. In addition, Oasmia was granted a new MSEK 40 bank loan in November 2013, which is due on 2014-03-31.
Warrants
A resolution was made at the Annual General Meeting 2013 to offer the company Board of Directors and management the right to subscribe for warrants in Oasmia Pharmaceutical AB. In October 2013, the maximum number of warrants were issued, 1 050 000, free from consideration, from the parent company to the subsidiary Oasmia Animal Health AB. The subsidiary has the right and obligation to transfer the warrants to the Board and management. For further details about terms, see the communiqué from the Annual General Meeting on the company website. As of January 2014, no acquisitions of warrants had been made.
Share price development during the period May 2013 – January 2014 (SEK)
EVENTS AFTER CLOSING DAY
Oasmia is granted FDA approval for Paccal Vet
On February 28, 2014, Oasmia announced that the American Food and Drug Administration (FDA) granted a conditional approval for the company's first pharmaceutical, Paccal Vet-CA1 and thereby provided veterinary oncologists with a new treatment option for squamous cell carcinoma and mammary carcinoma in dogs.
FINANCIAL INFORMATION
Consolidated Income Statement in brief
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | |
|---|---|---|---|---|---|
| TSEK | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 16 | - | 40 | - | - |
| Capitalized development cost | 8 072 | 10 626 | 22 078 | 37 810 | 48 635 |
| Operating income | -28 492 | -14 401 | -62 851 | -45 664 | -67 583 |
| Net income after tax | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 |
| Earnings per share (SEK), before and after dilution* | -0,37 | -0,20 | -0,82 | -0,77 | -1,06 |
| Comprehensive income for the period | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
THIRD QUARTER November 1, 2013 – January 31, 2014
Net sales Net sales amounted to TSEK 16 (-).
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to TSEK 8 072 (10 626). The larger part concerned Paclical which was capitalized with TSEK 5 781 (9 588) and a smaller part concerning Paccal Vet which contributed with TSEK 2 291 (1 038). The decrease compared to the same quarter in the previous year is attributable to decreased costs for clinical trials for Paclical®.
Operating expenses
Operating expenses excluding depreciation and impairment were significantly higher compared to the previous year and amounted to TSEK 35 370 (26 144). The nature of the operating expenses has changed. The costs for clinical trials have decreased somewhat, but costs related to preparations for the commercial phase Oasmia is planning for has increased more than the decrease in development costs. The latter refers to among other things method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
Income for the quarter
Net income was TSEK -30 436 (-15 540). The decrease between these two quarters was attributable to significantly increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III.
THE PERIOD May 1, 2013 – January 31, 2014
Net sales Net sales amounted to TSEK 40 (-) and concerned sales of supplies.
Capitalized development cost
Capitalized development cost, which concerns Phase III clinical trials, amounted to TSEK 22 078 (37 810). The larger part concerned Paclical which was capitalized with TSEK 14 443 (36 546) and a smaller part concerning
Paccal Vet which contributed with TSEK 7 635 (1 263). The decrease compared to the previous year is attributable to decreased costs for clinical trials for Paclical®.
Other operating income
Other operating income amounted to TSEK 4 420 (2 491) and mainly concerned an insurance compensation for a production disruption amounting to TSEK 4 250.
Operating expenses
Operating expenses excluding depreciation and impairment amounted to TSEK 85 631(82 139). The nature of the operating expenses has changed. The costs for clinical trials have decreased, but costs related to preparations for the commercial phase Oasmia is planning for has increased more than the decrease in development costs. The latter refers to among other things method development in production at Oasmia and its contract manufacturers and increased personnel and administration expenses.
The number of employees at the end of the period was 78 (77).
Income for the period
Net income was TSEK -67 321 (-49 428). The decrease was to a lesser extent attributable to increased operating expenses and a significantly decreased degree of capitalization of development costs in Phase III compared to the corresponding period the previous year.
The business activities of the Group have not been affected by seasonal variations or cyclic effects.
Cash flow and Capital expenditures
Cash flow from operating activities amounted to TSEK -59 437 (-51 100).
Cash flow from investing activities amounted to TSEK -25 152 (-48 889). The decreased level of investments concerned capitalized development costs and other intangible assets and property, plant and equipment.
Of these, investments in intangible assets amounted to TSEK 24 893 (48 777), consisting of capitalized development costs TSEK 22 078 (37 810) and patents and other intangible assets TSEK 2 815 (10 967).
Of these, only TSEK 259 (4 348) were investments in property, plant and equipment.
Financing
Financing in the period May – December 2013 was performed by liquid assets provided to the company in the preferential rights issue which was completed in November 2012 and a TSEK 4 250 insurance compensation. Thereafter, the financing has been performed by a TSEK 40 000 bank loan.
Financial position
The consolidated liquid assets at the end of the period amounted to TSEK 18 368 (92 338). The interest-bearing liabilities were TSEK 145 000 (105 000).
At the end of the period, unutilized credits with bank 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 amounted to TSEK 251 832 (342 143), the equity/assets ratio was 60 % (74 %) and the net debt/equity ratio was 50 % (4 %).
The parent company
The parent company´s net sales amounted to TSEK 40 (0) and net income before tax amounted to TSEK -67 299 (-49 438). The parent company's liquid assets at the end of the period amounted to TSEK 18 366 (92 329).
Key ratios and other information
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | |
|---|---|---|---|---|---|
| Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April | |
| Number of shares at the close of the period (in thousands), before and after dilution * |
81 772 | 81 772 | 81 772 | 81 772 | 81 772 |
| Weighted average number of shares (in thousands) before and after dilution* |
81 772 | 76 651 | 81 772 | 64 359 | 68 605 |
| Earnings per share in SEK, before and after dilution* | -0,37 | -0,20 | -0,82 | -0,77 | -1,06 |
| Equity per share, SEK* | 3,08 | 4,18 | 3,08 | 4,18 | 3,90 |
| Equity/Assets ratio, % | 60 | 74 | 60 | 74 | 72 |
| Net debt, TSEK | 126 632 | 12 662 | 126 632 | 12 662 | 42 044 |
| Net debt/Equity ratio, % | 50 | 4 | 50 | 4 | 13 |
| Return on total assets, % | neg | neg | neg | neg | neg |
| Return on equity, % | neg | neg | neg | neg | neg |
| Number of employees at the end of the period | 78 | 77 | 78 | 77 | 75 |
*Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the third quarter 2012/13.
Definitions
Earnings per share: The income for the period attributable to the shareholders of the parent company divided by a weighted average number of shares, before and after dilution.
Equity per share: Equity divided by the number of shares at the end of the period
Equity/assets ratio: Equity as a percentage of the balance sheet total.
Net debt: Total borrowing (containing the balance sheet items Short-term and Long-term borrowings and liabilities to credit institutions) with deduction for liquid funds
Net debt/Equity ratio: Net debt in relation to equity.
Return on total assets: Income before deduction of interest expenses in relation to the average balance sheet total.
Return on equity: Income after financial items in relation to the average equity.
Consolidated Income statement
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 16 | - | 40 | - | - | |
| Capitalized development cost | 8 072 | 10 626 | 22 078 | 37 810 | 48 635 | |
| Other operating income | 68 | 2 394 | 4 420 | 2 491 | 2 524 | |
| Raw materials, consumables and goods for resale | -1 429 | -1 018 | -3 715 | -4 876 | -6 137 | |
| Other external expenses | -22 007 | -13 667 | -48 155 | -46 244 | -65 022 | |
| Employee benefit expenses | -11 932 | -11 459 | -33 759 | -31 019 | -42 408 | |
| Depreciation/amortization and impairment | -1 279 | -1 277 | -3 758 | -3 824 | -5 089 | |
| Other operating expenses | -3 | - | -3 | - | -86 | |
| Operating income | -28 492 | -14 401 | -62 851 | -45 664 | -67 583 | |
| Financial income | 11 | 309 | 150 | 313 | 587 | |
| Financial expenses | -1 955 | -1 448 | -4 621 | -4 077 | -5 384 | |
| Financial items, net | -1 944 | -1 139 | -4 470 | -3 764 | -4 798 | |
| Income before taxes | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 | |
| Taxes | 2 | - | - | - | - | - |
| Income for the period | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 | |
| Income for the period attributable to: | ||||||
| Shareholders of the Parent company | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 | |
| Earnings per share before and after dilution, SEK | -0,37 | -0,20 | -0,82 | -0,77 | -1,06 | |
Consolidated Statement of Comprehensive income
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Income for the period | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 | |
| Comprehensive income for the period | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 | |
| Comprehensive income for the period attributable to: |
||||||
| Shareholders of the Parent company | -30 436 | -15 540 | -67 321 | -49 428 | -72 381 | |
| Comprehensive Earnings per share before and after dilu tion, SEK |
-0,37 | -0,20 | -0,82 | -0,77 | -1,06 |
Consolidated statement of financial position
| TSEK | Note | 2014-01-31 | 2013-01-31 | 2013-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 23 430 | 27 192 | 26 161 | |
| Capitalized development cost | 3 | 360 904 | 328 000 | 338 826 |
| Other intangible assets | 12 339 | 10 534 | 10 294 | |
| Financial assets | 2 | 2 | 2 | |
| Total Non-current assets | 396 675 | 365 729 | 375 283 | |
| Current assets | ||||
| Inventories | 1 656 | 887 | 887 | |
| Trade receivables | 59 | - | - | |
| Other current receivables | 3 159 | 2 490 | 2 314 | |
| Prepaid expenses and accrued income | 2 892 | 1 943 | 3 737 | |
| Liquid assets | 18 368 | 92 338 | 62 956 | |
| Total Current assets | 26 133 | 97 659 | 69 895 | |
| TOTAL ASSETS | 422 808 | 463 387 | 445 178 | |
| EQUITY | ||||
| Capital and provisions attributable to shareholders of the Parent Company | ||||
| Share capital | 8 177 | 8 177 | 8 177 | |
| Other capital provided | 573 439 | 573 475 | 573 439 | |
| Retained earnings | -329 784 | -239 510 | -262 463 | |
| Total equity | 251 832 | 342 143 | 319 153 | |
| LIABILITIES | ||||
| Non-current liabilities | ||||
| Other non-current liabilities | 891 | 891 | 891 | |
| Total Non-current liabilities | 891 | 891 | 891 | |
| Current liabilities | ||||
| Liabilities to credit institutions | 40 000 | - | - | |
| Short-term borrowings | 4 | 105 000 | 105 000 | 105 000 |
| Trade payables | 7 209 | 4 433 | 7 084 | |
| Other current liabilities | 1 449 | 1 570 | 1 566 | |
| Accrued expenses and prepaid income | 16 426 | 9 350 | 11 484 | |
| Total Current liabilities | 170 085 | 120 353 | 125 134 | |
| Total Liabilities | 170 976 | 121 244 | 126 025 | |
| TOTAL EQUITY AND LIABILITIES | 422 808 | 463 387 | 445 178 | |
| Contingent liabilities | 5 |
Pledged assets 5
Consolidated statement of changes in equity
| Attributable to shareholders of the Parent company |
||||||
|---|---|---|---|---|---|---|
| capital pro | Other | Retained | ||||
| TSEK | Share capital | vided | earnings | Total equity | ||
| Opening balance as of May 1, 2012 | 5 724 | 457 832 | -190 082 | 273 474 | ||
| Comprehensive income for the period | - | - | -49 428 | -49 428 | ||
| New share issue | 2 453 | 120 205 | - | 122 658 | ||
| Issue expenses | - | -4 562 | - | -4 562 | ||
| Closing balance as of January 31, 2013 | 8 177 | 573 475 | -239 510 | 342 143 | ||
| Opening balance as of May 1, 2012 | 5 724 | 457 832 | -190 082 | 273 474 | ||
| Comprehensive income for the period | - | - | -72 381 | -72 381 | ||
| New share issue | 2 453 | 120 205 | - | 122 658 | ||
| Issue expenses | - | -4 598 | - | -4 598 | ||
| Closing balance as of April 30, 2013 | 8 177 | 573 439 | -262 463 | 319 153 | ||
| Opening balance as of May 1, 2013 | 8 177 | 573 439 | -262 463 | 319 153 | ||
| Comprehensive income for the period | - | - | -67 321 | -67 321 | ||
| Closing balance as of January 31, 2014 | 8 177 | 573 439 | -329 784 | 251 832 | ||
| Consolidated Cash flow statement | ||||||
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | ||
| TSEK | Not | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Operating activities | ||||||
| Operating income before financial items | -28 492 | -14 401 | -62 851 | -45 664 | -67 583 | |
| Depreciation/amortization | 1 279 | 1 277 | 3 758 | 3 824 | 5 089 | |
| Disposals of tangible and intangible assets | 3 | - | 3 | - 86 |
||
| Adjustments for income from divestiture of intangible assets | - | -1 579 | - -1 579 |
-1 579 | ||
| Interest received | 11 | 309 | 150 | 313 | 587 | |
| Interest paid | -48 | -127 | -67 | -583 | -611 | |
| Cash flow from operating activities before working capital | ||||||
| changes | -27 248 | -14 521 | -59 007 | -43 688 | -64 010 | |
| Change in working capital | ||||||
| Change in inventories | 197 | - | -769 | -597 | -597 | |
| Change in trade receivables | -29 | - | -59 | - - |
||
| Change in other current receivables | -533 | -42 | 1 -524 |
-2 142 | ||
| Change in trade payables | 3 158 | -2 558 | 125 | -5 849 | -3 197 | |
| Change in other current liabilities | 653 | 825 | 273 | -441 | 408 | |
| Cash flow from operating activities | -23 802 | -16 296 | -59 437 | -51 100 | -69 539 | |
| Investing activities | ||||||
| Investments in intangible fixed assets | -8 484 | -10 996 | -24 893 | -48 777 | -59 603 | |
| Divestiture of intangible fixed assets | - | 4 235 | - 4 235 |
4 235 | ||
| Investments in property, plant and equipment | -197 | -67 | -259 | -4 348 | -4 428 | |
| Cash flow from investing activities | -8 681 | -6 828 | -25 152 | -48 889 | -59 795 | |
| Financing activities | ||||||
| Increase in liabilities to credit institutions | 40 000 | - | 40 000 | - - |
||
| Decrease in liabilities to credit institutions | - | -4 651 | - -3 197 |
-3 197 | ||
| New share issue | - | 122 658 | - 122 658 |
122 658 | ||
| Issue expenses | - | -4 562 | - -4 562 |
-4 598 | ||
| New loans | 4 | - | - | - 80 000 |
80 000 | |
| Repayment of loans | - | - | - -4 600 |
-4 600 | ||
| Cash flow from financing activities | 40 000 | 113 446 | 40 000 | 190 299 | 190 263 | |
| Cash flow for the period | 7 517 | 90 322 | -44 589 | 90 310 | 60 928 | |
| Cash and cash equivalents at the beginning of the period | 10 851 | 2 017 | 62 956 | 2 028 | 2 028 | |
| Cash and cash equivalents at the end of the period | 18 368 | 92 338 | 18 368 | 92 338 | 62 956 |
Parent Company Income statement
| 2013/14 | 2012/13 | 2013/14 | 2012/13 | 2012/13 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 16 | - | 40 | - | - | |
| Capitalized development cost | 8 072 | 10 626 | 22 078 | 37 810 | 48 635 | |
| Other operating income | 68 | 2 394 | 4 420 | 2 491 | 2 524 | |
| Raw materials, consumables and goods for resale | -1 429 | -1 018 | -3 715 | -4 876 | -6 137 | |
| Other external expenses | -21 986 | -13 632 | -48 109 | -46 151 | -64 916 | |
| Employee benefit expenses | -11 932 | -11 459 | -33 759 | -31 019 | -42 408 | |
| Depreciation/amortization and impairment of prop erty, plant, equipment and intangible assets |
-1 278 | -1 273 | -3 754 | -3 813 | -5 074 | |
| Other operating expenses | - | - | - | - | -86 | |
| Operating income | -28 469 | -14 363 | -62 799 | -45 559 | -67 461 | |
| Result from participations in Group companies | 4 | - | -30 | -30 | -115 | -145 |
| Other interest revenues and similar revenues | 11 | 309 | 150 | 312 | 587 | |
| Interest cost and similar costs | -1 955 | -1 448 | -4 621 | -4 076 | -5 384 | |
| Financial items, net | -1 944 | -1 169 | -4 500 | -3 879 | -4 942 | |
| Income after financial items | -30 413 | -15 532 | -67 299 | -49 438 | -72 404 | |
| Taxes | 2 | - | - | - | - | - |
| Income for the period | -30 413 | -15 532 | -67 299 | -49 438 | -72 404 |
Parent Company Balance Sheet
| TSEK | Note | 2014-01-31 | 2013-01-31 | 2013-04-30 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible fixed assets | ||||
| Capitalized development cost Concessions, patents, licenses, trademarks and |
3 | 360 904 | 328 000 | 338 826 |
| similar rights Property, plant and equipment |
12 339 | 10 524 | 10 288 | |
| Equipment, tools, fixtures and fittings Construction in progress and advance payments |
23 232 | 21 387 | 20 355 | |
| for property, plant and equipment | 197 | 5 805 | 5 805 | |
| Financial assets | ||||
| Participations in group companies | 110 | 110 | 110 | |
| Other securities held as non-current assets | 1 | 1 | 1 | |
| Total Non-current assets | 396 784 | 365 828 | 375 386 | |
| Current assets | ||||
| Inventories | ||||
| Raw materials and consumables | 1 656 | 887 | 887 | |
| 1 656 | 887 | 887 | ||
| Current receivables | ||||
| Trade receivables | 59 | - | - | |
| Other current receivables | 3 157 | 2 488 | 2 312 | |
| Prepaid expenses and accrued income | 2 892 | 1 943 | 3 721 | |
| 6 107 | 4 431 | 6 033 | ||
| Cash and bank balances | 18 366 | 92 329 | 62 947 | |
| Total current assets | 26 130 | 97 647 | 69 867 | |
| TOTAL ASSETS | 422 913 | 463 475 | 445 253 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 8 177 | 8 177 | 8 177 | |
| Statutory reserve | 4 620 | 4 620 | 4 620 | |
| 12 797 | 12 797 | 12 797 | ||
| Non-restricted equity | ||||
| Share premium reserve | 573 439 | 573 475 | 573 439 | |
| Retained earnings | -267 255 | -194 851 | -194 851 | |
| Income for the period | -67 299 | -49 438 | -72 404 | |
| 238 885 | 329 186 | 306 184 | ||
| Total equity | 251 682 | 341 984 | 318 981 | |
| Non-current liabilities | ||||
| Other non-current liabilities | 891 | 891 | 891 | |
| Total non-current liabilities | 891 | 891 | 891 | |
| Current liabilities | ||||
| Short term borrowings | 4 | 105 000 | 105 000 | 105 000 |
| Trade payables | 7 208 | 4 433 | 7 084 | |
| Liabilities to Credit institutions | 40 000 | - | - | |
| Liabilities to group companies | 257 | 247 | 247 | |
| Other current liabilities | 1 449 | 1 570 | 1 566 | |
| Accrued expenses and prepaid income | 16 426 | 9 350 | 11 484 | |
| Total Current liabilities | 170 340 | 120 600 | 125 381 | |
| TOTAL EQUITY AND LIABILITIES | 422 913 | 463 475 | 445 253 | |
| Contingent liabilities and pledged assets | ||||
| Contingent liabilities | 5 | - | - | - |
| Pledged assets | 5 | 8 000 | 8 000 | 8 000 |
Parent Company changes in equity
| Restricted equity | ||||
|---|---|---|---|---|
| TSEK | Share capital | Statutory reserve |
Non-restricted equity |
Total equity |
| Opening balance as of May 1, 2012 | 5 724 | 4 620 | 262 981 | 273 325 |
| New share issue | 2 453 | - | 120 205 | 122 658 |
| Issue expenses | - | - | -4 562 | -4 562 |
| Income for the period | - | - | -49 438 | -49 438 |
| Closing balance as of January 31, 2013 | 8 177 | 4 620 | 329 186 | 341 984 |
| Opening balance as of May 1, 2012 | 5 724 | 4 620 | 262 981 | 273 325 |
| New share issue | 2 453 | - | 120 205 | 122 658 |
| Issue expenses | - | - | -4 598 | -4 598 |
| Income for the period | - | - | -72 404 | -72 404 |
| Closing balance as of April 30, 2013 | 8 177 | 4 620 | 306 184 | 318 981 |
| Opening balance as of May 1, 2013 | 8 177 | 4 620 | 306 184 | 318 981 |
| Income for the period | - | - | -67 299 | -67 299 |
| Closing balance as of January 31, 2014 | 8 177 | 4 620 | 238 885 | 251 682 |
Note 1 Accounting policies
This report is established in accordance with IAS 34, Interim Financial Reporting and the Securities market Act. The consolidated accounts have been established in accordance with the International Financial Reporting Standards (IFRS) such as they have been adopted by the EU and interpretations by the International Financial Reporting Interpretations Committee (IFRIC), RFR 1, Complementary accounting regulations for Groups and the Annual Accounts Act. The Parent Company accounts are established in accordance with RFR 2, Accounting for legal entities and the Annual Accounts Act. The Group and Parent company accounting policies and calculation methods are unchanged compared to the ones described in the Annual Report for the fiscal year May 1 2012 – April 30 2013. The new and revised accounting policies applied by Oasmia since May 1, 2013, has not had any effect on Oasmia's financial reports. New or revised IFRS-standards or interpretations of IFRIC which have been adopted since May 1, 2013, have, beyond additional information regarding financial instruments as a result of the new IFRS 13, not had any effect on Oasmia's financial reports. Scope and character of financial assets and liabilities are in essence the same as of April 30, 2013. Similar to what was the case at the end of the previous fiscal year, carried amounts are the same as actual values. The Group currently only has one operating segment and does therefore not disclose any segment information.
Note 2 Taxes
The Group has accumulated losses carried forward amounting to TSEK 366 953 (277 622) and the Parent Company has similar amounting to TSEK 357 342 (268 082). Of the total losses carried forward for the Group, TSEK 17 881 (17 881) are restricted for use through group contributions. This limitation will end by the 2014 tax assessment. The future tax effect of these losses carried forward has not been marked with a value and no deferred tax asset has been considered in the Balance Sheet.
Note 3 Capitalized development cost
Capitalized development cost consists of the company's investments in clinical Phase III trials. The capitalization means that such costs are capitalized as an intangible asset. The accumulated assets per product candidate are disclosed below.
| TSEK | 2014-01-31 | 2013-01-31 | 2013-04-30 |
|---|---|---|---|
| Paclical® | 268 918 | 245 686 | 254 475 |
| Paccal® Vet | 91 986 | 82 315 | 84 351 |
| Total | 360 904 | 328 000 | 338 826 |
Note 4 Transactions with related parties
No significant transactions with related parties have been performed in the period.
As of January 31, 2014 Oasmia had a credit facility of TSEK 40 000 (40 000) provided by the principal owner of the company, Alceco International SA. The interest rate on utilized credits is 5 %. As of January 31, 2014, this credit was completely unutilized (also as of January 31, 2013).
On January 31, 2014, Oasmia carried a loan from its second largest owner Nexttobe AB amounting to TSEK 105,000 (105 000). In November 2013 the loan was extended with one year and it is now due on December 31, 2014. In 2014, the loan carries an interest of 8.5 % which previously was 5 % int. The interest will be paid when the loan is due. As of January 31, 2014 the accrued interest cost for the loan amounted to TSEK 9 335 (3 773).
Oasmia has made a TSEK 30 (115) group contribution to the subsidiary Qdoxx Pharma AB, where TSEK 0 (30) was provided in the third quarter. Impairment of shares in Qdoxx amounting to TSEK 30 (115) have been made, corresponding to the group contributions, as the purpose of the group contributions was to cover losses in the subsidiary. The impairment of Participations in group companies is accounted for in the Parent company income statement on the line Result from participations in group companies.
Note 5 Contingent liabilities and Pledged assets
The parent company has made a floating charge of MSEK 8 to a bank as security for a MSEK 5 bank overdraft and limit for a MSEK 3 exchange derivative.
Note 6 Risk factors
The Group is subjected to a number of different risks through its business. By creating awareness of the risks involved in the activities these risks can be limited, controlled and managed and at the same time as business opportunities can be utilized to increase earnings. The risks to Oasmia's business activities are described in the Annual report for the fiscal year May 1 2012 – April 30 2013. No additional risks beyond those described therein have been judged significant.
The Board of Directors and CEO of Oasmia Pharmaceutical AB ensures that this Interim report gives a correct overview of the Parent Company and Group activities, position and result and describes essential risks and uncertainty factors that the Parent Comp any and the companies that are part of the Group face.
UppsalaMarch6, 2014
Joel Citron,Chairman
| Bo Cederstrand, Member | Prof. Dr. Horst Domdey, Member | Alexander Kotsinas, Member |
|---|---|---|
| Jan Lundberg, Member | Martin Nicklasson, Member | Julian Aleksov, Member and CEO |
The information in this interim report is such that Oasmia Pharmaceutical (publ) must publish according to the code of trade in financial instruments. The information was delivered for publication on March 6, 2014 at 9.00.
This report hasbeen 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 OasmiaPharmaceutical AB (publ) Corp. Reg. No: 556332 -667601 Domicile: Stockholm
Address and telephone number to the Main Office Vallongatan 1 752 28 UPPSALA, SWEDEN +46 18 50 54 40 www.oasmia.com [email protected]
Questions concerning the report are answered by : Mikael Widell, Vice President Communications Phone +46 70 311 99 60 E-mail: Mika[email protected]om
UPCOMING REPORT DATES
| Year-end report May 2013 – April 2014 | 2014-06-05 |
|---|---|
| Annual report May 2013 – April 2014 | 2014-08-21 |
| Interim report May – July 2014 | 2014-09-05 |
| Interim report May – October 2014 | 2014-12-04 |
| Interim report May 2014 – January 2015 | 2015-03-05 |