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Vivesto — Interim / Quarterly Report 2008
Aug 28, 2009
3124_10-q_2009-08-28_d5621281-dfa8-4362-bd26-bff039e976e3.pdf
Interim / Quarterly Report
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Oasmia Pharmaceutical AB (publ)
Interim report for nine months, May 2007-January 2008
Promising results pushes Oasmia to next level
The period in brief
- Net sales for the group amounted to 53 224 SEK, thousands, (9 863 SEK, thousands)
- Operating profit/loss amounted to -4 822 SEK, thousands (-7 966 SEK, thousands)
- Profit after tax amounted to –4 937 SEK, thousands (- 8 430 SEK, thousands)
- Earnings per share amounted to –0,15 SEK (- 0,27 SEK)
Third quarter, Nov 2007-Jan 2008
- Net sales for the group amounted to 31 718 SEK, thousands (6 210 SEK, thousands)
- Operating profit/loss amounted to 11 632 SEK, thousands (-2 900 SEK, thousands)
- The profit after tax amounted to 11 866 SEK, thousands (-3 040 SEK, thousands)
- Earnings per share amounted to 0,36 SEK (-0,10 SEK)
Key events during the third quarter
In November Oasmia and Orion Corporation, Finland, entered a license- and distribution agreement with exclusive rights for marketing and sales of the pharmaceutical Paclical® for human use in the Nordic region (Sweden, Denmark, Norway, Finland and Iceland). Orion also obtained first right of refusal for the same region for an upcoming candidate from the Oasmia product portfolio. Oasmia received 2 million Euros during the third quarter. The company will receive another 2 million Euro when a registration of the pharmaceutical is obtained. Furthermore, the agreement also entitles Oasmia royalties on all sales. Oasmia will be responsible for clinical development, registration and production of Paclical®.
More negotiations were in progress with international partners regarding licensing of Paclical® and Paclial® Vet and Oasmia is expecting to close further agreements during 2008.
In November the results of the clinical Phase I/II study were presented at the annual Veterinary Cancer Society Congress in Florida.
In January Oasmia received final advice from the European Medicines Agency EMEA for the Phase III clinical development program for Paclical® on the indication ovarian cancer.
The company has recruited new competence and strengthened it's organization, mostly in clinical trials and production but also in the department of Regulatory Affairs. The number of employees increased during the period May 2007 – Jan 2008 with 12 people to a total of 41 people.
Key events after the close of the period
In the end of February Oasmia presented interim results from a Phase III study with the pharmaceutical candidate Paclical® Vet at a veterinary congress in Copenhagen. The congress was the first joint congress for the organizations ESVONC (European Society of Veterinary Oncology) in Europe and VCS (Veterinary Cancer Society) in the US. The results presented at the congress showed that 58 % of the 24 included dogs in the study treated with Oasmia's pharmaceutical candidate Paclical® Vet responded. Sixteen of these dogs underwent full treatment of three cycles and 62 % responded.
Future development
Focus is currently on an international Phase III study for Paclical® Vet in the EU and USA. This study is expected to fish in 2008 and will form the foundation for a global registration. Several negotiations are in progress globally concerning the licensing of the pharmaceutical candidate. The company also intends to launch a large international Phase III study with the product for human use, Paclical®. Far reaching negotiations concerning licensing are continued. Oasmia continues to develop the existing product portfolio and prepares several new products for clinical trials.
Business activities
The main business activity in the parent company Oasmia Pharmaceutical AB (publ) consists of research, development and production of in-house pharmaceuticals with an emphasis on oncology. Focus lies on human and veterinary oncology where the company has a solid product portfolio. The company office, research and production facility is situated in Uppsala, Sweden.
Oasmia owns 100 % of the subsidiary Qdoxx Pharma AB. The company's main business activity consists of parallel import of pharmaceuticals. The business idea of Qdoxx Pharma is to import and provide qualitative and price worthy pharmaceuticals on the Swedish market. Qdoxx Pharma has had a positive development trend during the period. Net sales has increased to 34 519 SEK, thousands (9 328 SEK, thousands). Oasmia also holds a 51 % share of the company GlucoGene Pharma AB. GlucoGene is a research company that has developed a novel type of xyloside. The aim is future treatment of brain tumours. The xylosides are currently in pre-clinical phase.
Research and Development
The Oasmia Pharmaceutical AB research and development activity is mainly directed towards human and veterinary oncology. The company research on the natural ageing and death of the cell has formed the platform for the development of the company's solid product portfolio, containing among others the unique pharmaceutical Paclical® and Paclical® Vet. The basis for the Oasmia product portfolio is a group of novel, unique and patented substances. One of these, XR-17, is specifically designed with the property to form micelles around the active part of the pharmaceutical. Oasmia's XR-17 can be used together with a variety of different substances in order to improve their profile and effect, especially substances that are sparsely water-soluble. The pharmaceuticals in the company product portfolio are all based on the excipient XR-17.
Product portfolio
The company product portfolio consists of Paclical® for human use and Paclical® Vet for veterinary use as well as the products Docecal®, Doxophos® and Carbomexx®. Oasmia sees its main task to implement the progression of the clinical Phase III programme for Paclical® and Paclical® Vet. Docecal®, Doxophos® and Carbomexx® are on the verge of entering clinical phase I/II- studies. These products covers theoretically 80 % of the standard treatments used today for the most common forms of cancer. Oasmia holds world-wide patents for all products.
Market
Of the total market for cytostatics, Paclical® is part of the group taxanes to which pharmaceuticals such as Taxol®, Taxotere® and Abraxane® belongs. The market size for this goup is about 2.5 billion USD in 2007 with an estimated annual growth of about 5 %. The prognosis for nanoparticle taxanes to which Paclical® belongs, are estimated reach 40 % of the total taxane market the coming five years.
FINANCIAL INFORMATION
Group income statement in brief
| 2007/08 | 2006/07 | 2007/08 | 2006/07 | 2006/07 | |
|---|---|---|---|---|---|
| SEK, thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-Apr |
| Net sales | 31 718 | 6 210 | 53 224 | 9 863 | 22 387 |
| Profit after tax | 11 866 | -3 040 | -4 937 | -8 430 | -11 752 |
| Basic and diluted earnings per share, SEK | 0,36 | -0,10 | -0,15 | -0,27 | -0,37 |
Net sales
Group net sales for the period May 1 2007 - Jan 31 2008 amounted to 53 224 SEK, thousands (9 863 SEK, thousands) where net sales for the third quarter amounted to 31 718 SEK, thousands (6 210 SEK, thousands) The increase compared to the corresponding period previous year are partly attributable to the revenue of 18 667 SEK, thousands that were acquired in accordance with the license- and distribution agreement that was closed with Orion Corporation and partly to an increase in sales of parallel imported pharmaceuticals in the subsidiary Qdoxx Pharma AB.
Work performed by the company for its own use and capitalilzed
During the period expenses amounting to 6 311 SEK, thousands (10 107 SEK, thousands) have been capitalized regarding Phase III studies for the products Paclical® and Paclical® Vet. For the third quarter the capitalized expenses amounted to 2 660 SEK, thousands (3 513 SEK, thousands)
Purchase of raw materials, consumables and goods for resale
These costs are mostly attributable to the business activity parallel import. At the end of the period the number of approved parallel imported products was 54 (28). With increased sales the costs have increased significantly. They amounted to -35 036 SEK, thousands (-10 228 SEK, thousands) for the period. For the third quarter the costs amounted to -12 428 SEK, thousands (-6 329 SEK, thousands).
Other external costs
Other external costs for the period amounted to -14 842 SEK, thousands (-8 537 SEK, thousands). For the third quarter the costs amounted to -4 705 SEK, thousands (-2 792 SEK, thousands). The costs are attributable in most part to products in development, that currently are in pre-clinical phase or Phase I/II. Costs during the period are also attributed to material and labour costs for the construction of a new clean room and auditing and consulting costs in connection to change in accounting policies.
Personnel costs
Personnel costs for the period amounted to -12 551 SEK, thousands (-7 305 SEK, thousands). For the third quarter the personnel costs amounted to -5 010 SEK, thousands (-2 866 SEK, thousands). During the period May 1 2007 – Jan 31 2008 the number of employees has increased with 12 persons to 41 at the end of the period.
Financial position
Liquid resources for the group amounted to 11 313 SEK, thousands (1 416 SEK, thousands) at Jan 31 2008.
Cash flow from operating activities amounted to -4 236 SEK, thousands (-13 007 SEK, thousands) for the period and for the third quarter to 11 927 SEK, thousands (-7 681 SEK, thousands). The cash flow for the period was –10 856 SEK, thousands (-2 220 SEK, thousands) and the cash flow for the third quarter was 7 140 SEK thousands (-252 SEK, thousands).
Equity amounted to 64 942 SEK, thousands (36 744 SEK, thousands). Equity/assets ratio as of Jan 31 2008 was 76 % (66 %).
Group Income statement
| 2007/08 | 2006/07 | 2007/08 | 2006/07 | 2006/07 | ||
|---|---|---|---|---|---|---|
| SEK, thousands | Note | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 2 | 31 718 | 6 210 | 53 224 | 9 863 | 22 387 |
| Work performed by the company for its | ||||||
| own use and capitalized | 2 660 | 3 513 | 6 311 | 10 107 | 14 484 | |
| Other operating income | 82 | 0 | 82 | 0 | 0 | |
| Raw material, consumables and goods | ||||||
| for resale | -12 428 | -6 329 | -35 036 | -10 228 | -22 621 | |
| Other external costs | -4 705 | -2 792 | -14 842 | -8 537 | -12 154 | |
| Employee benefit expenses | -5 010 | -2 866 | -12 551 | -7 305 | -10 559 | |
| Depreciation/amortization and impair | ||||||
| ment | -685 | -636 | -2 010 | -1 866 | -2 521 | |
| Operating profit/loss | 11 632 | -2 900 | -4 822 | -7 966 | -10 986 | |
| Financial income | 414 | 12 | 416 | 20 | 21 | |
| Financial expenses | -180 | -152 | -532 | -485 | -787 | |
| Financial items profit/loss | 234 | -140 | -116 | -464 | -766 | |
| Profit before tax | 11 866 | -3 040 | -4 937 | -8 430 | -11 752 | |
| Income tax | 0 | 0 | 0 | 0 | 0 | |
| Profit/loss for the period | 11 866 | -3 040 | -4 937 | -8 430 | -11 752 | |
| Attributable to: | ||||||
| Parent company owners | 11 869 | -3 038 | -4 929 | -8 425 | -11 748 | |
| Minority share holding | -4 | -2 | -8 | -4 | -4 | |
| Basic and diluted earnings per share, | ||||||
| calculated on the profit attributable to | ||||||
| Parent company share holders during the period | ||||||
| (SEK per share) | 0,36 | -0,10 | -0,15 | -0,27 | -0,37 | |
| Group Balance Sheet | |||
|---|---|---|---|
| 2008 | 2007 | 2007 | |
| SEK, thousands | Jan 31 | Jan 31 | April 30 |
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 19 091 | 19 699 | 19 416 |
| Capitalized expenditure for development | 20 795 | 10 161 | 14 484 |
| Other intangible assets | 8 459 | 7 890 | 7 849 |
| Current assets | |||
| Inventories | 18 142 | 8 722 | 18 318 |
| Accounts receivable - trade | 4 712 | 5 631 | 4 386 |
| Other current receivables | 823 | 733 | 833 |
| Prepaid expenses and accrued income | 1 736 | 1 418 | 1 373 |
| Liquid assets | 11 313 | 1 416 | 22 170 |
| Total assets | 85 072 | 55 670 | 88 830 |
| EQUITY | |||
| Equity and reserves attributed to parent company share holders | |||
| Share capital | 3 338 | 3 185 | 3 185 |
| Other paid-up capital | 95 767 | 59 419 | 95 919 |
| Profit/loss brought forward | -34 261 | -25 929 | -29 331 |
| Minority shareholding | 98 | 68 | 106 |
| Total equity | 64 942 | 36 744 | 69 879 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Borrowing | 7 499 | 6 170 | 5 513 |
| Deferred tax liabilities | 8 | 8 | 8 |
| Current liabilities | |||
| Liabilities to credit institutions | 4 595 | 2 204 | 2 461 |
| Borrowing | 2 933 | 2 933 | 2 933 |
| Accounts payable - trade | 1 096 | 2 224 | 4 564 |
| Other current liabilities | 2 164 | 4 308 | 1 966 |
| Accrued expenses and deferred income | 1 835 | 1 078 | 1 506 |
| Total equity and liabilities | 85 072 | 55 670 | 88 830 |
Change in group equity
| 2007/08 May-Jan |
2006/07 May-Jan |
2006/07 May-April |
|
|---|---|---|---|
| Bal. b/f according to the balance sheet | 69 879 | 20 582 | 20 582 |
| Profit/loss for the period | -4 937 | -8 430 | -11 752 |
| Translation difference | 0 | -8 | -51 |
| Refunded share holder contribution | -61 100 | -34 904 | -34 904 |
| Issue of new shares | 61 100 | 34 904 | 34 904 |
| Share holder contribution received | 0 | 24 600 | 61 100 |
| Amount at the end of the period | 64 942 | 36 744 | 69 879 |
Cash flow statement for the Group
| 2007/08 | 2006/07 | 2007/08 | 2006/07 | 2006/07 | |
|---|---|---|---|---|---|
| SEK, thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Operating activities | |||||
| Operating profit/loss before financial items | 11 632 | -2 902 | -4 822 | -7 966 | -10 986 |
| Depreciations | 685 | 637 | 2 010 | 1 866 | 2 521 |
| Interest received | 414 | 12 | 416 | 20 | 21 |
| Interest paid | -180 | -152 | -532 | -485 | -787 |
| Cash flow from operating activities before work | |||||
| ing capital changes | 12 551 | -2 404 | -2 927 | -6 564 | -9 231 |
| Working capital change | |||||
| Inventory change | 265 | -4 434 | 176 | -6 048 | -15 645 |
| Change in accounts receivables -trade | 3 455 | -4 017 | -325 | -5 332 | -4 087 |
| Change in other current receivables | -100 | -262 | -352 | 44 | -12 |
| Change in accounts payable -trade | -4 387 | -514 | -3 468 | 1 598 | 3 937 |
| Change in other current operating liabilities | 144 | 3 950 | 2 661 | 3 297 | 1 715 |
| Cash flow from operating activities | 11 927 | -7 681 | -4 236 | -13 007 | -23 322 |
| Investing activities | |||||
| Investments in intangible fixed assets | -3 893 | -4 063 | -7 505 | -10 914 | -15 519 |
| Investments in property, plant and equipment | -216 | -358 | -1 102 | -968 | -1 136 |
| Cash flow from investing activities | -4 109 | -4 421 | -8 606 | -11 881 | -16 655 |
| Financing activities | |||||
| Share holder contribution received | 0 | 12 500 | 0 | 24 600 | 61 100 |
| Borrowings | 0 | 0 | 4 000 | 0 | 0 |
| Repayment of loans | -678 | -651 | -2 014 | -1 932 | -2 589 |
| Cash flow from financing activities | -678 | 11 849 | 1 986 | 22 668 | 58 511 |
| Cash flow for the period | 7 140 | -252 | -10 856 | -2 220 | 18 534 |
| Cash and cash equivalents at the beginning of | |||||
| the period | 4 173 | 1 668 | 22 170 | 3 635 | 3 635 |
| Cash and cash equivalents at the end of the | |||||
| period | 11 313 | 1 416 | 11 313 | 1 416 | 22 170 |
Key ratios and other information
| 2007/08 Nov-Jan |
2006/07 Nov-Jan |
2007/08 May-Jan |
2006/07 May-Jan |
2006/07 May-Apr |
|
|---|---|---|---|---|---|
| Basic and diluted number of shares at the close of the period, in thousands |
33 375 | 31 851 | 33 375 | 31 851 | 31 851 |
| Weighted basic and diluted average number of shares, in thousands |
33 375 | 31 851 | 32 365 | 31 287 | 31 429 |
| Basis and diluted earnings per share, SEK | 0,36 | -0,10 | -0,15 | -0,27 | -0,37 |
| Equity per share, SEK | 1,94 | 1,15 | 1,94 | 1,15 | 2,19 |
| Equity/assets ratio, % | 76 | 66 | 76 | 66 | 79 |
| Return on total assets, % | 15 | -6 | -5 | -18 | -18 |
| Return on equity, % | 20 | -9 | -7 | -28 | -26 |
| Number of employees at the end of the period | 41 | 25 | 41 | 25 | 29 |
| Number of outstanding shares at the end of the period |
0 | 0 | 0 | 0 | 0 |
Definitions
Basic and diluted earnings per share: Earnings after tax divided by the basic and diluted average number of shares
Equity per share: Equity corresponding to number of shares at the end of the period
Equty/assets ratio: Equity as a percentage of the balance sheet total
Return on total assets: The operating profit/loss plus financial income as a percentage of average balance sheet total
Return on equity: Net profit/loss in percent of average equity
Parent company income statement
| 2007/08 | 2006/07 | 2007/08 | 2006/07 | 2006/07 | |
|---|---|---|---|---|---|
| SEK, thousands | Nov-Jan | Nov-Jan | May-Jan | May-Jan | May-April |
| Net sales | 18 667 | 248 | 18 706 | 534 | 973 |
| Work performed by the company for its own | |||||
| use and capitalized | 2 660 | 3 513 | 6 311 | 10 107 | 14 484 |
| Other operating income | 48 | 0 | 48 | 0 | 0 |
| Raw material, consumables and goods for | |||||
| resale | -224 | -404 | -938 | -1 125 | -1 516 |
| Other external costs | -4 458 | -2 547 | -14 109 | -8 086 | -11 431 |
| Employee benefit expenses | -5 010 | -2 806 | -12 532 | -7 119 | -10 373 |
| Depreciation/amortization and impairment | -631 | -594 | -1 843 | -1 706 | -2 312 |
| Operating profit/loss | 11 052 | -2 590 | -4 357 | -7 394 | -10 175 |
| Other interest income and similar income | 412 | 12 | 414 | 20 | 21 |
| Interest expense and similar expense | -75 | -133 | -244 | -355 | -486 |
| Financial items profit/loss | 338 | -121 | 170 | -335 | -465 |
| Profit before tax | 11 390 | -2 711 | -4 187 | -7 730 | -10 640 |
| Tax on profits for the period | 0 | 0 | 0 | 0 | 0 |
| Profit/loss for the period | 11 390 | -2 711 | -4 187 | -7 730 | -10 640 |
Parent Company Balance Sheet
| 2008 | 2007 | 2007 | |
|---|---|---|---|
| SEK, thousands | Jan 31 | Jan 31 | April 30 |
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 19 091 | 19 696 | 19 413 |
| Capitalized expenditure for development | 20 795 | 10 161 | 14 484 |
| Other intangible assets | 7 539 | 7 011 | 6 737 |
| Financial assets | 2 118 | 2 024 | 2 100 |
| Current assets | |||
| Inventories | 33 | 86 | 37 |
| Accounts receivable - trade | 0 | 292 | 93 |
| Receivables from group companies | 17 658 | 11 067 | 17 676 |
| Other receivables | 769 | 681 | 763 |
| Prepaid expenses and accrued income | 1 262 | 1 081 | 1 117 |
| Cash and bank balances | 11 282 | 1 235 | 20 280 |
| Total assets | 80 548 | 53 334 | 82 701 |
| EQUITY | |||
| Restricted equity | |||
| Share capital | 3 338 | 3 185 | 3 185 |
| Statutory reserve | 4 620 | 4 620 | 4 620 |
| Non-restricted equity | |||
| Share premium reserve | 95 767 | 34 819 | 34 819 |
| Profit/Loss brought forward | -32 139 | 4 420 | 39 601 |
| Loss for the Period | -4 187 | -7 730 | -10 640 |
| Total equity | 67 399 | 39 315 | 71 585 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Borrowing | 7 499 | 6 170 | 5 513 |
| Current liabilities | |||
| Borrowing | 2 933 | 2 933 | 2 933 |
| Accounts payable | 195 | 431 | 656 |
| Other current liabilities | 687 | 3 437 | 508 |
| Accrued expenses and deferred income | 1 835 | 1 048 | 1 506 |
| Total equity and liabilities | 80 548 | 53 334 | 82 701 |
| Contingent liabilities | 8 473 | 3 473 | 8 473 |
Change in Parent Company equity
| 2007/08 May-Jan |
2006/07 May-Jan |
2006/07 May-April |
|---|---|---|
| 71 585 | 22 444 | 22 444 |
| -119 | ||
| -61 100 | -34 904 | -34 904 |
| 61 100 | 34 904 | 34 904 |
| 0 | 24 600 | 61 100 |
| 0 | 0 | -1 200 |
| -4 187 | -7 730 | -10 640 |
| 67 399 | 39 315 | 71 585 |
| 0 | 0 |
NOTES
Note 1 Accountant policies
This interim report is established in accordance with IAS 34 Interim reporting. The group accounts and the parent company accounts has been established in accordance with the Annual Accounts act, RR 30:05, complementary accounts regulations for groups and International Financial Reporting Standards (IFRS), in accordance with the EU regulations. The group accounts has been established according to the cost method. The accounting principles are described more in detail in the company Listing Prospectus on September 18, 2007.
Note 2 Segment reporting
The interim period May 1 2007 – January 31 2008
| SEK, thousands | Research and Development |
Parallel import |
|---|---|---|
| Net sales | 18 706 | 34 519 |
| Work performed by the company for its | ||
| own use and capitalized Other operating income |
6 311 48 |
0 34 |
| Operating profit/loss | -4 372 | -450 |
Note 3 Essential risks and uncertainty factors
An account is given below of a number of risk factors that can affect the development of the company. There has been no attempt to rank these; nor should they be taken to be all inclusive. Risk factors that, in the current situation, have not been identified, or have not been deemed to be important, can affect the company's future development.
Products
Because of the high development costs that are associated with the main business area of the company, there is a risk that the company can be affected if test results of a product turn out to be unsatisfactory.
Side-effects
Since the company's main area of business is in the development of pharmaceuticals, there is a risk that patients that either participate in clinical studies of the company's products, or in some other way, come into contact with the company's products will develop serious side-effects. Side-effects can have a negative effect on the company.
Relations with government agencies
The business operations of Oasmia Pharmaceuticals depend on permits granted by various government agencies, international as well as Swedish. There is a risk that a necessary permit can not be obtained without extensive investigations or an expensive modification of business operations. Oasmia strives for cost efficiency in all aspects of its operations.
Competition
There is keen competition in the field of oncology with many available products. Development is on-going and there is a risk that competitors on the market can affect the company's results.
Financing and collaboration
Oasmia is financed primarily by capital from shareholders and banks. It can not be ruled out that in the future the company will need to acquire additional capital or face worsened interest terms. Nor can the company guarantee that additional capital can be obtained. Moreover, to a certain extent, Oasmia's growth is dependent on establishing collaborative ventures with external partners in the form of industrial contracts and collaborative agreements with international pharmaceutical companies. If important collaborative ventures can not be entered into, are terminated, or do not work satisfactorily, this can have a negative effect on the company. The company's goal is to create firm agreements with its partners and long-term financial growth.
Patents
Oasmia has patents for all steps of product development the world over. There is a risk that competitors will violate these patents and that a dispute might arise. This can have a negative effect on the company.
Key persons
Oasmia depends on a highly qualified workforce in order to conduct first-class research. Further, the company depends on being able to continue to recruit competent workers even in the future. There is a risk that there might be a lack of such workers. This can have a negative effect on the company.
Share trading
The company is listed on NGM Equity. If trading liquidity does not develop or become lasting, this can make it difficult for shareholders to sell their shares. There is also a risk that the market price may differ significantly from today's share price.
DATES FOR FINANCIAL INFORMATION
Year-end report 2008-06-16
This interim report has not been subjected to auditing of the company auditors.
The Board and CEO of Oasmia Pharmaceutical ascertains that the interim report gives a just overview of the parent company and the group business activities, position and results as well as describes essential risks and uncertainty factors that the parent company and the companies that are part of the group faces.
Uppsala March 14, 2008
Bo Cederstrand, Chairman Claes Pihl, member of the board Peter Ström, member of the board Julian Aleksov, Chief Executive Officer