AroCell AB (publ) Year-End report 2014
Reporting Period January 1 – December 31 2014
- Net sales resulted in 0 (0) KSEK
- Profit before tax declined to -6 369 (-3 733) KSEK
- Earnings per share declined to-0,32 (-0,24) SEK
- Cash conversion from operating activities amounted to -5 726 (-4 055) KSEK
Reporting Period 1 October – 31 December 2014
• Net sales resulted in 0 (0) KSEK
• Profit before tax declined to -4 167 (-1 531) KSEK
• Cash conversion from operating activities amounted to -2 442 (-1 973) KSEK
• Resource and knowledge reinforcement within clinical research and quality systems and regulatory matters was achieved through recruitment of Lotta Nordin and Alf Malmberg
• Initial testing of TK 210 ELISA in RUO-kit version indicates results according to plan
• The AroCell share issue in October was fully subscribed, bringing 18 149 KSEK to the company after associated new issue expenses.
Key activities during the report period
- The development phase for TK 210 ELISA is finalized and a transfer to production initialized
- A preliminary market research has been conducted in key European markets. The results have provided a good overview of the conditions for introduction of TK 210 ELISA to market.
- Lotta Nordin has been recruited with responsibility for planning, coordinating and execution of clinical studies.
- Alf Malmberg has been recruited to insure CE-mark status of TK 210 ELISA as well as responsibility for corporate quality assurance system.
- A new share issue with preferential rights was issued under October 2014 with a subscription level of approximately 129 procent. A total of 4 265 628 new shares were issued. The share capital increased with 426 562,80 kronor to 2 346 096 kronor. Approximately 18 149 KSEK was brought to AroCell after associated new issue expenses.
Key events after the reporting period
- During the course scaling-up the production process for TK 210 ELISA, unforeseen issues have arisen causing a delay of approximately 6 months.
- The production related issues are identified and are being addressed accordingly. The revised schedule means that the company will introduce a CE-marked product during third quarter of 2015.
Comments from CEO Jan Stålemark, AroCell: It is with confidence that we will now initiate our preparations for launch of our TK 210 ELISA test. We have been working with special focus on product performance and reproducibility in the production process. We are pleased with the evidence that the performance of the product meets the specification requirements.
We have encountered some challenges in the process of gearing up to large scale production. This is not unusual when gearing up to large scale production of in vitro diagnostic products. We have identified certain issues and taken actions which we determine will secure both a reproducible and robust end-product. Our revised expectation is to have a product with CE-mark status available during the third quarter of this year.
We have conducted a number of clinical studies to form a foundation of clinical evidence at the introduction of our CE-marked version of the TK 210 ELISA test during autumn 2015.
Additionally, more comprehensive clinical studies are planned for the remainder of this year.
We are entering a very intensive period, where we are establishing collaboration with distributors, clinicians and other interested parties within the health care sector regarding the application and utilization of our product. This collaboration will form the basis of our business models and marketing and sales strategies. Our highest priority is and always will be a close collaboration with our customers.
Financial risk management
AroCells operations are based on external financing. The company has succeeded well with financing up to the current time, however there are no future guarantees to corporate shareholders regarding beneficial aspects in this respect. An unsuccessful endeavour in regard to future financing can affect the corporate development and market value.
Product development and production risk management
There are always risks associated with product development and transfer to the production process. There is no assurance that a product from full-scale production process has the same characteristics and qualities as a product produced on a research scale level. The development of future products may also be more complex and take longer time than originally estimated.
Commercialisation risk management
There is always a risk that the products developed by AroCell are not positively received in the market place according to expectations and acceptance time can be prolonged. The quality of sold products can in this respect, with special regard to the initial introduction phase,, be lower and the time for product establishment on the market can be longer than what the corporation has estimated in sales calculations. In addition to this, there are risks associated with patents, market evaluation of clinical studies, approvals and certifications. By taking consideration to risk factors in the decision processes, and during the development of routines and documentation, risk evaluation and their effects may be minimized or avoided.
This year-end report has been prepared in accordance with the Swedish Annual Accounts Act and Accounting Council general policy BFNAR 2012:1 Årsredovisning och Koncernredovisning (K3)
The transfer to K3 has not influenced the comparison year figures, which means that the presented comparisons coincide with the information presented in the annual report for 2013.
The total amount of shares in AroCell amounted to 23 460 960 shares as per the 31 December 2014 (value 0,10 kr).
Key individual shareholdings
|Staffan Eriksson and relatives||946 581||1 057 862||+111 281|
|Håkan Englund and relatives||240 437||311 558||+71 121|
|Jan Mellberg||142 470||193 473||+51 003|
|Bengt Norvik||32 626||56 077||+23 451|
|Erik Walldén, relatives *||0||50 000||+50 000|
|Jan Stålemark *||0||30 000||+30 000|
|Filip Fogdestam *||0||14 815||+14 815|
* Registered in May 2014
About AroCell AB
AroCell AB is a Swedish company in Uppsala, Sweden. AroCells technology is based on an innovative method to measure the speed of cell division in the human body, which can provide a measurement of how aggressive a cancer tumor may be. This is done by means of a simple blood test and a laboratory test, called TK 210 ELISA, which provides valuable clinical information for prognosis, monitoring and optimizing cancer treatment. The test may also be used for follow-up and in treatment of potential disease relapse. AroCell is listed on the Swedish AktieTorget and has approximately 1 365 shareholders. For more information, please see www.arocell.com