A new Australian study, using the Swedish instrument Nevisense, showed it is possible to reduce the number of cases that require digital dermoscopy follow-up by almost half. In addition Nevisense detected most melanoma three months earlier than traditional methods. Nevisense thereby constitutes a valuable complement to a visual exam with a dermatoscope. The study consisted of 118 patients with 160 lesions, and the results will be presented for the first time at the World Congress on Cancers of the Skin in Vienna on September 1.
Malignant melanoma is often difficult to detect, and early detection is of crucial importance. Lesions suspected of being malignant melanoma, but which cannot be clearly determined during the initial examination, are followed up in many cases with the help of what is known as short term digital dermoscopy imaging (SDDI), which means that the lesion is photographed and compared over time.
The use of SDDI is increasing – especially in difficult-to-diagnose cases – but it is resource-intensive and can take three months or more for a final diagnosis. In addition, it can be challenging to get patients to return for follow-up visits.
In the new Australian study, conducted by Dr Lilian Rocha, Associate Prof. Pascale Guitera, Prof. Scott W. Menzies et. al. at the Melanoma Institute of Australia and Royal Prince Alfred Hospital in Sydney, SDDI was combined with Nevisense’s electrical impedance spectroscopy (EIS) measurement with the following results:
19% of all examined lesions showed a Nevisense EIS value of seven or more and were surgically removed immediately. 83.1% of the malignant melanoma in the study was discovered by Nevisense three months earlier than what SDDI would have allowed.
28% showed a Nevisense EIS value of three or less, which would have made the need for a patient follow-up visit unnecessary.
The combination of SDDI and Nevisense detected 100% of all malignant melanoma in the study.
In total, the use of Nevisense showed the potential to reduce the number of cases that needed to undergo SDDI by 47%. This could simplify diagnostics and lead to significant cost savings for health care while shortening patients’ waiting time for a diagnosis.
“The cases in the study involve difficult-to-diagnose lesions, and the current diagnostic process is time consuming for both clinicians and patients. This study result is very important because it shows the potential for Nevisense to improve the process - saving both time and resources in the healthcare sector” says Simon Grant, CEO at SciBase.
For more information, please contact: Simon Grant, CEO Phone: +46 72 887 43 99 Email: [email protected]
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 10.00 CET on August 26, 2016.
About Skin Cancer Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to the age of 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
With its new instrument, Nevisense View, SciBase combines its patented electrical impedance spectroscopy (EIS) for early detection of malignant melanoma with visual information from digital dermascopy, creating a complete instrument that can both improve and simplify the diagnostic process.
Malignant melanoma is the most threatening form of skin cancer and is behind 75 percent of all skin cancer deaths. The key to successful treatment of malignant melanoma is early discovery, since this aggressive form of cancer can quickly spread throughout the body. The cancer is often difficult to detect, and digital dermascopy is one of the methods used for detection. This method is based on visual evaluations of skin lesions using a dermascope, while hard-to-diagnose cases often make use of short term digital dermoscopy imaging (SDDI) to compare pictures of lesions that have changed over time.
SciBase is now integrating the digital dermascopy method into its new product and combining it with EIS technology, which uses electrical impulses to detect abnormal cell structures that could be a sign of malignant melanoma. Furthermore, SciBase’s new instrument also simplifies the process for performing skin examinations since all information from the exam is saved in the same instrument. The ability to track the changes of a suspicious lesion, both using EIS values and images, helps prevent both the unnecessary removal of benign tissue and helps avoid malignant melanoma going undetected during an examination.
“According to a new study, conducted by researchers from Melanoma Institute of Australia and Royal Prince Alfred Hospital in Sydney, the use of EIS can reduce the number of cases that need to be followed up using SDDI by almost half, and may also allow for early detection of malignant melanoma three months earlier than traditional methods,” says Simon Grant, CEO of SciBase.
“Being able to combine these two methods into one product and present it in conjunction with a study that supports our method at the World Congress on Cancers of the Skin in Vienna on August 31 is of course a milestone in the company’s history,” says Simon.
Nevisense View simplifies caregivers’ work by offering the following functions:
Wireless transfer of images to Nevisense
Combination of EIS, image and patient information as a PDF report for full documentation of the examination.
Easy-to-use follow-up functions, such as a shared screen for being able to compare lesions over time.
Nevisense View will be available in Sweden and in SciBase’s other markets in November. More information about the study can be found here:Swedish Nevisense can reduce follow up visits by half for difficult-to-diagnose skin changes in melanoma detection
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on August 31, 2016.
About Skin Cancer Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to the age of 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
In June SciBase took over production of single-use electrodes from Ginolis, and as a result the company has chosen to strengthen its management team with Marko Päivärinne. Päivärinne is the company’s Production and Logistics Manager and has worked at SciBase since August 2015.
Aside from the fact that SciBase will have full control over production and thereby better conditions for making it more cost-efficient in the future, the integration of electrode manufacturing means that product development will be easier. Marko Päivärinne will be a part of the management team to help bring additional focus to these aspects of manufacturing.
“Electrode production is strategically our most important process, and it will continue to be of great value to us. Therefore, it is very natural for Marko to be a part of the management team. An important part of our work right now is about increasing the volume of electrodes that are being produced using the semi-automated process that Ginolis developed for us,” says Simon Grant, CEO at SciBase.
During the past year, Marko has worked to streamline the supply chain, and has focused on reducing purchasing costs for the components included in electrode manufacturing in order to improve margins – work that he will continue.
Marko has twelve years of experience from the medical technology company Arthrocare Medical Corporation, where he worked with supply chain management and demand planning in addition to implementing business systems. He has also been responsible for managing a number of international acquisitions.
SciBase’s product Nevisense requires a new electrode for every patient examined. SciBase’s business model is based on selling instruments, but the major potential lies in the continuous use of the instruments, which generates revenues from the sale of the single-use electrodes. During the second quarter of 2016 SciBase increased sales of the electrodes by 212 percent in Germany, the company’s primary market.
For more information, please contact: Simon Grant, CEO Phone: +46 72 887 43 99 Email: [email protected]
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CEST on September 7, 2016.
About Skin Cancer Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to the age of 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
The loss after tax amounted to TSEK 11,600 (9,179).
The loss per share amounted to SEK 1.40 (1.84).
The cash flow from current operations was negative in the amount of TSEK 11,247 (9,197).
Significant margin improvement with gross margin increasing to 26.3% in Q1 (2.6% Q1 15).
Important events during the quarter
SciBase’s PMA application was accepted on January 14th as complete starting the formal evaluation process by the FDA. There has been a high level of interaction between SciBase and the FDA during and continuing after the first quarter.
Continued good growth in key market Germany with total sales up 20% and electrode sales volume up 49%.
SciBase has signed a distribution agreement for Switzerland with CDP SWISS AG. The sales and marketing effort of SciBase’s melanoma detection product Nevisense will initially focus on the nearly 400 dermatologists that work in private clinics in Switzerland.
A change in the Company’s board of directors was communicated as Viktor Dvrota, as a result of his appointment as Head of Investment at Karolinska Development, has resigned from SciBase’s Board of Directors. Alternate director Andreas Pennervall will take his place.
Important events after the end of the period
On April 25th, the Annual Report for 2015 was published.
Apr 1 2015 -
Jan 1 - Mar 31
Mar 31 2016
Jan 1 - Dec 31
THE GROUP
2016
2015
Rolling-12
2015
Net sales, SEK ths
1 066
1 057
4 160
4 151
Gross margin, %
26,3%
2,6%
8,5%
2,5%
Equity/Asset ratio, %
94,4%
73,0%
94,4%
95,1%
Net indebtness, multiple
0,06
0,37
0,06
0,05
Cash equivalents, SEK ths
122 241
17 313
122 241
133 736
Cashflow from operating activities, SEK ths
-11 247
-9 197
-48 638
-46 588
Earnings per share (before and after dilution), SEK*
-1,40
-1,84
-5,68
-6,01
Shareholder's equity per share, SEK*
16,19
4,71
17,34
21,09
Average number of shares, 000'*
8 285
4 985
7 735
6 910
Number of shares at closing of period, 000'*
8 285
4 985
8 285
8 285
Share price at end of period, SEK
23,50
-
23,50
31,00
Average number of employees
18
14
15
14
*Adjusted for in May 2015 performed reversed split, 40:1
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
SciBase Holding AB is required to disclose the information provided herein pursuant to the Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 8 am on May 13, 2016.
At the annual general meeting of SciBase Holding AB (publ) on 16 May 2016 in Stockholm the shareholders adopted the below resolutions.
Resolution regarding adoption of the profit and loss account and balance sheet for the company and the group as well as resolutions in respect of appropriation of profits and discharge from liability
The meeting resolved to adopt the profit and loss account and balance sheet for the group and the Company included in the annual report.
The meeting resolved to allocate the profit for the year in accordance with the board of directors’ proposal, i.e. SEK 242,298,179 was carried forward.
The meeting resolved to discharge the board members and managing director from liability for their management of the Company's affairs during the preceding financial year.
Resolution regarding the number of members of the board of directors and deputies
The meeting resolved that the Company's board of directors shall consist of six ordinary members and two deputies.
Resolution regarding the remuneration for the board of directors and the auditor
The meeting resolved that fees to the board of directors for the financial year 2016 shall be paid with SEK 150,000 to the chairman of the board and SEK 100,000 to external members of the board of directors who do not own shares, are founders or represent a larger shareholder in the Company. Board members shall, provided that the circumstances so allow from a tax perspective and that no additional costs will be incurred by the Company, be allowed to invoice the fee.
It was resolved that fees to the Company's auditor shall be paid in accordance with approved current account.
Resolution on guidelines for determination of salary and other remuneration to senior management
The meeting resolved to adopt guidelines for determination of salary and other remuneration to senior management in accordance the board’s proposal.
Resolution regarding members of the board of directors and auditor
For the time until the end of the next annual general meeting, the meeting resolved to elect Andreas Pennervall (new election) Tord Lendau (re-election), Carsten Browall (re-election), Stig 0llmar (re-election), Per Aniansson (re-election) and Renee Aguiar-Lucander (re-election) as ordinary members of the board of directors. Anna Gustafsson (new election) and Victoria Torell (new election) were elected as deputy members of the board of directors for the time until the end of the next annual general meeting. Ernst & Young AB was re-elected as auditor with Björn Ohlsson as responsible auditor for the time until the end of the next annual general meeting.
Resolution regarding appointment of nominating committee
The meeting resolved to adopt principles for the appointment the nominating committee for the annual general meeting 2017 in accordance with the nominating committee’s proposal.
Resolution regarding authorization of the board of directors to issue new shares, issuance of warrants and/or convertibles
The meeting resolved unanimously to authorize the board of directors to, during the time until the next annual general meeting, decide upon issuances of new shares, issuance of warrants and/or convertibles. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company and payment may be used for strategic acquisitions, and may be made either in cash and/or by way of set-off or contribution in kind or otherwise on specific terms. The number of shares issued, or number of shares created in connection with exercise of warrants or conversion of convertibles, shall not exceed 820,000.
SciBase Holding AB is required to disclose the information provided herein pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 08:00 am on May 17, 2016.
About Skin Cancer
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
The production of disposable electrodes for SciBase’s device Nevisense, which is of high strategic importance, will be brought in-house. The companies have mutually agreed to transfer the manufacturing to SciBase when the current manufacturer Ginolis has completed the next milestone in the stepwise automation of the production process.
- The production of the electrodes is our most strategic and important process, which is why we want to handle it internally. We believe that by fully controlling the production process it is easier for us to drive the development of a more cost effective production forward. We would like to take the opportunity to thank Ginolis for their professional services and the high quality of the electrodes produced, says Simon Grant, CEO at SciBase.
As a preparatory step two former Ginolis employees, who have been involved in the production of the electrodes, are now employed by SciBase. The production itself will continue from Ginolis’ current premises in Uppsala.
By integrating the manufacturing of the electrodes into SciBase’s operations, product development including improvements of the design and the technology itself of the electrodes is facilitated.
- In addition to a more efficient R&D process, we also get a deeper understanding of the production process, which enables SciBase to better evaluate the production from a strategic perspective in the future, says Anna Danström, Manager Electrode Development at SciBase.
When using Nevisense, a new electrode is required for every patient examined. SciBase’s business model is based on selling instruments, but the major potential lies in the continuous use as it generates revenues from the sale of the single-use electrodes. During the first quarter of 2016 SciBase increased sales of the electrodes with 34 percent. The company does not expect the margin, which improved strongly in 2016, to be affected notably short-term.
For more information, please contact: Simon Grant, CEO Phone: +46 72 887 43 99 Email: [email protected]
The information in this press release is disclosed by SciBase Holding AB (publ) in accordance with the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 08.00 a.m. CET, on 23 June 2016.
About Skin Cancer Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to the age of 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
The interest in and acceptance of SciBase’s method for early detection of malignant melanoma is increasing, which is demonstrated by the fact that the 100th clinic in Germany installed SciBase’s device Nevisense in June. Sales of electrodes; an effect of the adoption of Nevisense, are steadily increasing and rose by 208 percent in Germany during 2015.
SciBase founded its German subsidiary in the first quarter of 2015 and the company has since successfully built up its own local sales organization. Germany is SciBase’s most important market and accounted for more than 80 percent of SciBase’s turnover during 2015. The installation of the device in the 100thclinic in Germany marks an important milestone for SciBase.
- Germany is, and will be for some time, our largest and most important market. We’re very pleased with the positive trend we are seeing there. The fact that there are now 100 clinics that have adopted Nevisense to improve and make their diagnosis of malignant melanoma more efficient, is a sign of the increasing acceptance of our method in Germany, says Simon Grant, CEO at SciBase.
SciBase’s business model is based on customers initially purchasing a Nevisense device and then buying new tests (electrodes) on an on-going basis. Sales of electrodes increased by more than 200 percent in the German market during 2015, which is a sign that both physicians and patients appreciate the Nevisense device and the value it adds.
The 100thGerman clinic that offers skin checks with Nevisense is Dermatologie Euskirchen in the federal state of North Rhine-Westphalia
- We are doing about 350 skin checks each month, which is about 50 percent of our patients in total. We want to offer modern and science-based diagnostics. Nevisense increases the safety for both physicians and patients as it makes evaluating suspicious lesions easier, which in the end decreases the amount of unnecessary excisions. If the examination is done only with the help of dermoscopy, the diagnosis is based only on the physician’s knowledge and experience. However by using Nevisense, we add an objective value to the diagnosis, which also is easy to understand for the patients, says Dr. med. Christina Huerkamp and Andrea Schuster, dermatologist at Dermatologie Euskirchen.
For more information, please contact: Simon Grant, CEO Phone: +46 72 887 43 99 Email: [email protected]
About Skin Cancer Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to the age of 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
Total net sales amounted to TSEK 1 181 (460), +157%.
The loss after tax amounted to TSEK 11,154 (10,256).
The loss per share amounted to SEK 1.35 (2.06).
The cash flow from current operations was negative in the amount of TSEK 13,864 (9,290).
The full year in figures
Total net sales amounted to TSEK 4,151 (1,600), +159%.
The loss after tax amounted to TSEK 41,532 (38,755).
The loss per share amounted to SEK 6.01 (7.78).
The cash flow from current operations was negative in the amount of TSEK 46,588 (37,077).
Important events during the quarter
In the period, SciBase submitted the premarket approval (PMA) application for Nevisense to the FDA (US Food and Drug Administration). FDA has now accepted the application (according to press-release in January 2016) and is now moving on to the evaluation phase. The PMA is the FDA’s most rigorous process for approval of new medical devices for the US market and is required for most class III devices. Class III devices are usually based on a new method that has not been approved by the FDA yet. Due to the complex and resource-intensive process only about 30 companies per year apply for a PMA. If successful, SciBase will be one of only a handful Swedish companies that have completed the PMA process.
Important events after the end of the period
After the end of the period a change in the Company’s board of directors was communicated. Viktor Dvrota, as a result of his appointment as Head of Investment at Karolinska Development, has resigned from SciBase’s Board of Directors. Alternate director Andreas Pennervall will take his place.
Financial overview
Oct 1 - Dec 31
Jan 1 - Dec 31
THE GROUP
2015
2014
2015
2014
Net sales, SEK ths
1 181
460
4 151
1 600
Gross margin, %
18,4%
-41,5%
2,5%
-36,0%
Equity/Asset ratio, %
95,1%
78,5%
95,1%
78,5%
Net indebtness, multiple
0,05
0,27
0,05
0,27
Cash equivalents, SEK ths
133 736
27 566
133 736
27 566
Cashflow from operating activities, SEK ths
-9 669
-9 290
-46 588
-37 077
Earnings per share (before and after dilution), SEK*
-1,35
-2,06
-6,01
-7,78
Shareholder's equity per share, SEK*
17,59
6,55
21,09
6,55
Average number of shares, 000'*
8 285
4 985
6 910
4 984
Number of shares at closing of period, 000'*
8 285
4 985
8 285
4 985
Average number of employees
15
11
14
12
*Adjusted for in May 2015 performed reversed split, 40:1
SciBase has signed a distribution agreement for Switzerland with CDP SWISS AG. The sales and marketing effort of SciBase’s melanoma detection product Nevisense will initially be focused on the nearly 400 dermatologists that work in private clinics in Switzerland.
Switzerland is the country in Europe with the highest prevalence of malignant melanoma. Each year approximately 2,500 new cases of the disease are diagnosed, which makes the market potentially very interesting for SciBase. Approximately 70 percent of the 500 dermatologists in Switzerland operate full time at private clinics.
- Switzerland is one of Europe’s smaller markets, but we believe that there is good potential there. A high proportion of skin cancer screenings take place in private clinics – clinics that are usually more open to new methods. With CDP SWISS AG we have a distributor with well-established contacts right into our target customer and they have a good track record of similar products, says Simon Grant, CEO of SciBase.
By signing an agreement with one of the premier distributors of medical devices for dermatologists, SciBase will firmly establish Nevisense on the Swiss market. While the focus of CDP SWISS AG will be private dermatologists, they will also address the nine hospital-based public clinics as these clinics often evaluate products and publish results – and this can in turn influence the private clinics.
- We are very pleased to be able to represent SciBase and Nevisense in Switzerland. With Nevisense, the health care system gains access to an objective tool which helps to identify early stage malignant melanoma that in the end might save lives. There is a great interest in methods to improve diagnosis and many Swiss Doctors have heard of Nevisense from their German colleagues, says Falk Dörstling, CEO of CDP SWISS AG.
CDP SWISS AG specialize on medical technology products for dermatologists, with a focus on laser-based products. They offer a complete coverage of Switzerland. The Company has been active for 10 years and has shown strong growth from the start, thanks to their strong customer relationships.
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
The shareholders of SciBase Holding AB, reg. no. 556773-4768, (hereinafter the “Company”) are hereby invited to the annual general meeting to be held on 16 May 2016, at 5 PM at Setterwalls Advokatbyrå’s offices with address at Sturegatan 10 in Stockholm.
Registration
Shareholders who wish to attend the AGM must be recorded in the share register held by Euroclear Sweden AB on Tuesday May 10, 2016 and notify the company of their intention to attend by no later than Tuesday May 10, 2016, preferably before 3.00 p.m. CET. Notice of attendance is made in writing to SciBase Holding AB, P.O. Box 3337, 103 67 Stockholm, Sweden, or by e-mail [email protected] or by phone +46-8-410 620 00. The notice of attendance shall include name, personal or corporate ID number, address and phone number. The same dates, addresses, etc. apply for notifying the company of any accompanying advisors. Powers of attorneys, certificates of incorporation and other documents of authorization must be presented at the AGM, but can preferably be sent to the company in connection with the notice of attendance.
Shareholders whose shares are registered in the names of nominees must temporarily register the shares in their own name in order to be entitled to attend the annual general meeting (so called voting registration). In order for such voting registration to be completed on May 10, 2016 the shareholders must inform their nominees well before this date.
A shareholder's rights at the meeting may be exercised by a proxy empowered by a power of attorney. The power of attorney shall be in writing, dated and signed and must not be older than five years. The original power of attorney must be presented at the meeting. Those representing a legal person must also present a certificate of registration or the similar showing the authorized signatories. A proxy form is available on the company’s website, www.scibase.com.
Proposed agenda
1. Opening of the meeting 2. Election of chairman of the meeting 3. Drawing up and approval of the voting list 4. Approval of the agenda 5. Election of one or two persons to adjust the minutes 6. Resolution regarding whether the meeting has been duly convened 7. Presentation of the annual report and the auditor's report 8. Resolutions regarding:
i. adoption of the profit and loss account and balance sheet; ii. allocation of the Company's result according to the adopted balance sheet; and iii. adischarge from liability for members of the board of directors and the managing director 9. Resolution regarding the number of members and deputies of the board of directors 10. Resolution regarding the remuneration for the board of directors and the auditor 11. Resolution on guidelines for determination of salary and other remuneration to senior management 12. Resolution regarding members of the board of directors and auditor 13. Resolution regarding appointment of nominating committee 14. Resolution regarding authorisation for the board of directors to resolve upon issues of shares, warrants and convertibles 15. Closing of the meeting
Proposals
Election of chairman of the meeting – item 2
Attorney-at-law Mattias Detterfelt is proposed to act as chairman of the meeting.
Allocation of the Company's result – item 8 (ii)
The board of directors and the managing director proposes that the profit of the year is allocated so that SEK 242 298 179 is carried forward. No dividend to the shareholders is thus proposed.
Resolution regarding the number of members and deputies of the board of directors – item9
Shareholders representing approximately 60 percent of the Company's total votes and capital propose that the Company's board of directors shall consist of six ordinary members and two deputies.
Resolution regarding the remuneration for the board of directors and the auditor - item 10
Shareholders representing approximately 60 percent of the Company's total votes and capital propose that a fee of SEK 150,000 shall be paid to the chairman of the board and SEK 100,000 to external members of the board of directors who does not own shares, are founders or represent a larger shareholder in the Company.
Board members shall, provided that the circumstance so allow from a tax perspective and that no additional costs will be incurred by the Company, be allowed to invoice the fee.
Fees to the Company's auditor shall be paid in accordance with approved current account.
Resolution on guidelines for determination of salary and other remuneration to senior management – item 11
The Board of Directors proposes that the Annual General Meeting resolve to adopt the following guidelines for the remuneration of senior management members for the period extending until the 2017 Annual General Meeting.
The remuneration of the senior management members shall comprise fixed salary, variable salary, pension and other benefits. The total remuneration package should be based on market terms, be competitive and reflect the individual’s performance and responsibilities as well as the Group’s earnings trend.
The variable salary may comprise annual incentives in cash and long-term incentives in cash, shares and /or share-based instruments in the Company. Variable salary in cash is conditional upon the fulfillment of defined and measurable goals and should be maximized in relation to the fixed salary. Long-term incentives in the form of shares and /or share-based instruments in the Company may be provided through participation in long-term incentive programs approved by the General Meeting. Terms and conditions for variable salary should be designed so that the Board of Directors, if exceptional economic circumstances prevail, has the option of limiting or refraining from payment of variable salary if such a measure is considered reasonable.
In specific cases, agreements may be reached regarding one-off remuneration amounts provided that such remuneration does not exceed an amount corresponding to the individual’s annual fixed salary and maximum variable salary in cash, and is not paid more than once per year and individual.
Pension benefits should either be defined benefit or defined contribution, or a combination there of. The retirement age for the President is a minimum of 60 and for other senior management members the retirement age is a minimum of 62.
Members of the senior management generally have a period of notice of not more than 12 months. The Board is to have the right to depart from the guidelines resolved on by the Annual General Meeting if, in an individual case, there are special reasons for this.
The sphere of senior executives encompassed by the guidelines comprises the President and other members of senior management.
Val av styrelse och revisor - punkt 12 / Resolution regarding members of the board of directors and auditor – item 12
Aktieägare representerande cirka 60 procent av Bolagets totala röster och kapital föreslår val av styrelseledamöter, suppleanter och revisor för tiden intill slutet av nästa årsstämma, i enlighet med följande:
Shareholders representing approximately 60 percent of the Company's total votes and capital propose election of members and deputies of the board of directors and auditor for the period until the end of the next annual general meeting, as follows:
Board members:
1. Tord Lendau (re-election) 2. Carsten Browall (re-election) 3. Stig Ollmar (re-election) 4. Per Aniansson (re-election) 5. Renee Lucander (re-election) 6. Andreas Pennervall (new election)
Deputies:
1. Victoria Torell (new election) 2. Anna Gustafsson (new election)
Auditor:
Ernst & Young AB, with Björn Ohlsson as responible auditor (re-election)
Resolution regarding appointment of nominating committee – item 13
Shareholders representing approximately 60 percent of the total votes and capital in the Company propose the following decision for election of a nominating committee for the annual general meeting 2017:
The nominating committee for the annual general meeting 2017, which shall comprise of four members, shall be appointed by way of that the chairman of the board of directors will consult with the three largest shareholders of the Company at the end of the third quarter of 2016. These shareholders will be requested to each appoint one representative who, together with the chairman of the board of directors, will form the nominating committee. The composition of the nominating committee shall be publicly announced no later than six months prior to the annual general meeting. The nominating committee, whose mandate period applies until the end of the annual general meeting 2017, shall appoint a chairman among its members. The nominating committee shall prior to the annual general meeting 2017 prepare and submit proposals regarding the election of the chairman of the meeting, the number of board members and deputy members, the election of board members, deputy members and auditor, remuneration for the board of directors and the auditor, as well as guidelines for the appointment of the nominating committee for the following annual general meeting. The nominating committee’s proposals shall be presented in the notice to a general meeting where election of board members and auditor shall take place and on the Company’s website. Should a member of the nominating committee resign from its assignment, a replacement shall be sought from the shareholder that appointed the departing member. Should a shareholder that has appointed a representative in the nominating committee substantially decrease its ownership in the Company, the next shareholder in size order shall, if the nominating committee so resolves, be requested to appoint a representative to the nominating committee.
Resolution regarding authorisation for the board of directors to resolve upon issues of shares, warrants and convertibles - item 14
The board of directors proposes that the annual general meeting resolves to authorise the board of directors to, until the next annual general meeting, on one or more occasions, decide upon issuances of new shares, issuance of warrants and/or convertibles. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company and payment may be used for strategic acquisitions, and may be made either in cash and/or by way of set-off or contribution in kind or otherwise on specific terms. The number of shares issued, or number of shares created in connection with exercise of warrants or conversion of convertibles, shall not exceed 820,000.
Information at the annual general meeting
Upon request by any shareholder and where the Board of Directors believes that such may take place without significant harm to the Company, the Board of Directors and the President should provide information at the Annual General Meeting in respect of any circumstances which may affect the assessment of a matter on the agenda, and any circumstances which may affect the assessment of the Company’s or a subsidiary’s financial position and as regards the Company’s relationship to other group companies.
Majority Requirements
For resolution in accordance with items 14 on the agenda, it is required that the general meeting’s resolution is supported by shareholders representing at least two thirds of the shares represented the votes cast at the general meeting.
Documents
The financial statements and auditor's report will be available in the Company's offices and at the Company’s website www.scibase.com as of 25 April 2016. Copies of the aforementioned documents will also be sent by post to shareholders who so request and provide their postal addresses. The proposals of the board of directors and the nominating committee are set out in full in the notice.
