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.
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 April 25, 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 loss after tax amounted to TSEK 10,260 (7,935).
The loss per share amounted to SEK 1.24 (1.59).
The cash flow from current operations was negative in the amount of TSEK 9,669 (9,578).
The 9-months in figures
Total net sales amounted to TSEK 2,970 (1,140).
The loss after tax amounted to TSEK 30,378 (28,499).
The loss per share amounted to SEK 4.71 (5.72).
The cash flow from current operations was negative in the amount of TSEK 32,724 (27,787).
Important events during the quarter
During the period the high level results from the “Reader-study” in the US were published. The results from the study show that the addition of Nevisense significantly improved the ability of US dermatologists to accurately detect melanoma. The Reader Study is an important requirement of the application process to the US Food and Drug Administration (FDA). With the results from the study, SciBase can now finalize and file its PMA application with the FDA.
Pareto Securities has during the period exercised the possibility to, in connection with the initial public offering of SciBase Holding AB (publ) (“SciBase”), carry out stabilization-like transactions. All stabilization-like transactions were carried out between June 2, 2015 and June 10, 2015 and no further stabilization-like transactions will be carried out.
Important events after the end of the period
No significant events after the period have been reported.
Financial overview
Oct 1 2014 -
July 1 - Sep 30
Jan 1 - Sep 30
Sep 30 2015
Jan 1 - Dec 31
THE GROUP
2015
2014
2015
2014
Rolling-12
2014
Net sales, SEK ths
995
818
2 970
1 140
3 430
1 600
Gross margin, %
17,6%
-42,8%
-3,8%
-33,9%
-8,9%
-36,0%
Equity/Asset ratio, %
94,2%
84,4%
94,2%
84,4%
94,2%
78,5%
Net indebtness, multiple
0,06
0,19
0,06
0,19
0,06
0,27
Cash equivalents, SEK ths
147 661
37 176
147 661
37 176
147 661
27 566
Cashflow from operating activities, SEK ths
-9 669
-9 578
-32 724
-27 787
-42 014
-37 077
Earnings per share (before and after dilution), SEK*
-1,24
-1,59
-4,71
-5,72
-6,68
-7,78
Shareholder's equity per share, SEK*
18,93
8,61
24,31
8,61
25,78
6,55
Average number of shares, 000'*
8 285
4 985
6 451
4 984
6 085
4 984
Number of shares at closing of period, 000'*
8 285
4 985
8 285
4 985
8 285
4 985
Average number of employees
15
12
14
12
14
12
Definitions and a glossary are provided on page 15.
The U.S. Food and Drug Administration (FDA) has confirmed that the organization has received SciBase’s application for a pre-market approval (PMA) of the Nevisense device for the US market.
“We have been working with the clinical studies and documentation that the FDA requires for several years. It has been a long process that culminated in the completion of the application during this quarter. The US market is the world’s largest and represents a significant opportunity for SciBase. Even a limited penetration of our method and Nevisense has the possibility to transform our business”, says Simon Grant, CEO of SciBase.
The PMA is the FDA’s most rigorous process for approval of new medical devices for the US market and is required for most so-called class III devices. Class III devices are usually based on a new method that has not yet been approved by the FDA. Due to the complex and resource-intensive process only about 30 companies apply for a PMA each year. If successful, SciBase will be one of only a handful of Swedish companies to complete a PMA process.
A PMA application contains detailed information covering the device’s development, manufacturing as well as the clinical trials that confirm the device’s safety and effectiveness in use. In dialogue with the FDA, SciBase has developed and conducted the world’s largest clinical study on detection of malignant melanoma. In addition, SciBase presented the results from a so-called Reader study during the third quarter. The Reader study was the final piece needed in order to complete the application.
The FDA is now starting the review of SciBase’s PMA application. The company estimates that a decision from the FDA will be reached by the end of 2016, a more exact date is however hard to estimate.
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. The key to management is early detection, which is a challenge due to lack of objective tools for diagnosis, a problem that Nevisense addresses.
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 December 2015 SciBase submitted its application for pre-market approval of its Nevisense device to the U.S. Food and Drug Administration (FDA). Scibase has now received confirmation that FDA considers that the application is complete and contains all necessary information to move on to the evaluation phase and start to review the application.
The PMA is the FDA’s most rigorous process for approval of new medical devices for the US market and is required for most so-called 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.
“I have been through the PMA process before and know what it entails. Every step, such as the confirmation that our application is considered complete, takes us one step closer to our final goal of an approval. The FDA is now going to start the actual review of our application, which comprises several thousand pages”, says Simon Grant, CEO of SciBase.
A PMA application contains detailed device information and demonstrates its safety and effectiveness in use. The application consists of the following components:
Description of the device and the method
Detailed history of development as well as manufacturing processes
Detailed results of all conducted clinical studies, including among others SciBase’s pivotal study, the largest study of its kind, as well as the Reader study conducted in 2015
Information on documentation which is available to clients
Summary of all evidence that shows that the product meets the FDA’s requirements
Since the FDA confirmed that they received the application, SciBase has provided limited complementary information. The FDA now starts to review SciBase’s PMA application and the company estimates that a decision from the FDA will be reached by the end of 2016. A more exact date is however difficult to estimate.
SciBase’s device Nevisense is a tool to help doctors detect malignant melanoma. 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. The key to management is early detection, which is a challenge due to lack of objective tools for diagnosis, a problem that Nevisense addresses.
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.
As a result of his appointment as Head of Investment at Karolinska Development, Viktor Drvota has resigned from SciBase’s Board of Directors. Alternate director Andreas Pennervall will take his place.
Viktor Drvota moves on to Karolinska Development having been Head of Life Science Venture at SEB Venture Capital. Viktor has been a member of SciBase’s board since 2005. Andreas Pennervall has been an alternate director in SciBase’s board since 2013.
Information on Viktor Drvota’s withdrawal has been submitted to the Swedish Companies Registration Office on January 29th.
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 February 2, 2016.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL.
Pareto Securities has exercised the possibility to, in connection with the initial public offering of SciBase Holding AB (publ) (“SciBase”), carry out stabilization-like transactions.
All stabilization-like transactions were carried out between June 2, 2015 and June 10, 2015 in the price interval of SEK 44.6 to SEK 50.0. The period for stabilization-like transactions has now ended and no further stabilization-like transactions will be carried out.
Interval per day
Date
Interval
June 2, 2015
SEK 47.5–50.0
June 3, 2015
SEK 48.4–49.3
June 4, 2015
SEK 47.3–49.5
June 5, 2015
SEK 47.5–48.5
June 8, 2015
SEK 47.1–47.8
June 9, 2015
SEK 44.8–46.8
June 10, 2015
SEK 44.6–46.2
A total of 495,000 shares in SciBase that Pareto Securities borrowed from SEB Venture Capital, SEB Pensionsstiftelse and Fouriertransform Aktiebolag have been returned.
For further information please visit www.scibase.com or contact:
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 Certified Adviser. Further information is available on www.scibase.com.
IMPORTANT NOTICE
This announcement is not and does not form a part of any offer for sale of securities.
Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Switzerland, South Africa or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.
Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.
In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.
Matters discussed in this announcement may constitute forward-looking statements. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
The loss after tax amounted to TSEK 10,939 (11,552).
The loss per share amounted to SEK 1.80 (2.32).
The cash flow from current operations was negative in the amount of TSEK 13,858 (7,959).
The half-year in figures
Total net sales amounted to TSEK 1,975 (322).
The loss after tax amounted to TSEK 20,118 (20,564).
The loss per share amounted to SEK 3.63 (4.13).
The cash flow from current operations was negative in the amount of TSEK 23,055(18,209).
Important events during the quarter
In April, SciBase announced its intention to launch an Initial Public Offering and listing on Nasdaq First North.
At an Extraordinary General Meeting on April 28, resolutions were taken to:
- introduce a share-based incentive program,
- consolidate shares and reduce the share capital,
- authorize the Board to make decisions regarding new share issues
The Company completed a rights issue that raised MSEK 165 before issue costs. The Offering was significantly oversubscribed, resulting in a substantially broadened shareholder base consisting of both institutions and private shareholders. .
The Company’s shares were listed on Nasdaq First North on June 2nd.
Vinnova granted MSEK 3.9 for the development of the next generation device to SciBase and KTH.
In April, an exclusive distributor agreement for the Austrian market was signed with Intramed Handels GesmbH.
The Company expanded its sales resources in Germany.
In April, SciBase established a Scientific Advisory Board consisting of international experts in the field of skin cancer
The Company received an additional US patent approval.
Important events after the end of the period
The Company announced that Pareto Securities has exercised the possibility to, in connection with the initial public offering of SciBase Holding AB (publ) (“SciBase”), carry out stabilization-like transactions.
Financial overview
July 1 2014 -
Apr 1 - Jun 30
Jan 1 - Jun 30
Jun 30 2015
Jan 1 - Dec 31
THE GROUP
2015
2014
2015
2014
Rolling-12
2014
Net sales, SEK ths
918
258
1 975
322
3 253
1 600
Gross margin, %
-34,5%
-10,1%
-14,6%
-11,2%
-25,5%
-36,0%
Equity/Asset ratio, %
91,4%
84,8%
91,4%
84,8%
91,4%
78,5%
Net indebtness, multiple
0,09
0,18
0,09
0,18
0,09
0,27
Cash equivalents, SEK ths
165 595
46 903
165 595
46 903
165 595
27 566
Cashflow from operating activities, SEK ths
-13 858
-7 959
-23 055
-18 209
-41 923
-37 077
Earnings per share (before and after dilution), SEK*
-1,80
-2,32
-3,63
-4,13
-7,26
-7,78
Shaeholder's equity per share, SEK*
27,41
10,20
30,13
10,20
31,71
6,55
Average number of shares, 000'*
6 085
4 985
5 535
4 983
5 260
4 984
Number of shares at closing of period, 000'*
8 285
4 985
8 285
4 985
8 285
4 985
Average number of employees
13
11
14
11
13
12
*Adjusted for in May 2015 performed reversed split, 40:1
SciBase today announces the results from their Reader Study in the US. The results from the study show that the addition of Nevisense significantly improved the ability of US dermatologists to accurately detect melanoma. The Reader Study is an important requirement of the application process to the US Food and Drug Administration (FDA). With the results from the study, SciBase can now compile their complete application.
“We are very pleased with the result of the study. This was the last requirement from the US FDA for our Pre-Market Approval (PMA) application for Nevisense on the US market. Now that the Reader study is successfully completed, we can finalize and submit our application”, says Simon Grant, CEO of SciBase.
41 US dermatologists reviewed online 141 randomly selected potential melanoma lesions; first with an image of each lesion together with patient information, and then with Nevisense information added.
The results showed that the use of Nevisense significantly improves physicians’ ability to detect melanoma, whilst also satisfying the goal set for accuracy. This meant the study met both primary endpoints agreed with the FDA.
“The study results are in addition to the results from the SciBase pivotal study published last year, but with a different approach and with a broad group of US dermatologists. This shows that Nevisense has the potential to provide additional valuable information to clinicians in the difficult task of accurately detecting malignant melanomas”, says Simon Grant, CEO of SciBase.
Approval from the FDA is required for SciBase to be able to market and sell Nevisense in the US, the world’s largest medical device market. By meeting the FDA’s requirements for the study, SciBase can now finalize its pre-market approval (PMA) application, which is scheduled for submission before the end of 2015.
SciBase’s point-of-care device 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 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.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL.
SciBase Holding AB (publ) (“SciBase” or the “Company”) today announces the outcome of its offering to subscribe for new shares in SciBase (the “Offering”) in connection with the planned listing on Nasdaq First North.
The interest for the Offering has been strong, both among the general public in Sweden and among institutional investors in Sweden and abroad, and the Offering was significantly oversubscribed.
The Offering in brief
As previously announced, the price in the Offering is SEK 50 per share, implying a pre-money market capitalization of SEK 249 million, based on SciBase’s 4,984,768 shares outstanding prior to the Offering.
The Offering originally comprised 3,000,000 new shares, but has, in accordance with the terms of the Offering, been increased by 300,000 additional new shares to comprise a total of 3,300,000 new shares, corresponding to approximately 40% of the shares and votes in SciBase after completion of the Offering (excluding the Over-allotment option).
SciBase has granted an over-allotment option to Pareto Securities of up to 495,000 additional new shares, corresponding to up to 15% of the total number of shares in the Offering (the “Over-allotment option”). If the Over-allotment option is fully exercised, the Offering comprises in total 3,795,000 new shares, corresponding to approximately 43% of the shares and votes in SciBase after completion of the Offering.
The Over-allotment option can, according to the terms of the Offering, be exercised, at one or more occasions, whole or in parts, by Pareto Securities up until and including July 1, 2015.
The total value of, and gross proceeds from, the Offering is SEK 165 million (excluding the Over-allotment option).
If the Over-allotment option is fully exercised, the total value of, and gross proceeds from, the Offering is SEK 190 million.
The existing shareholders SEB Venture Capital, SEB Pensionsstiftelse, Fouriertransform and Omega Fund IV, L. P. (the “Cornerstone Investors”) participated in the Offering with SEK 19.4 million, SEK 13.5 million, SEK 12.6 million and SEK 4.5 million, respectively – in aggregate SEK 50 million. The Cornerstone Investors will jointly hold approximately 57% of the shares and votes in SciBase if the Over-allotment option is fully exercised.
Existing investors other than the Cornerstone Investors participated in the IPO with an aggregate amount of approximately SEK 14 million.
As a result of the Offering, around 4,000 new investors have been allocated shares in SciBase.
The new investors include both specialist and generalist institutional investors from Sweden and abroad, as well as Swedish retail investors.
Trading in SciBase’s shares on Nasdaq First North is planned to commence on Tuesday, June 2, 2015, under the ticker “SCIB”.
Simon Grant, CEO, comments:
We are very pleased to see such a high level of interest from such a varied group of investors. The high demand has allowed us to fully increase the size of the offering, bringing the company additional capital to further increase sales efforts in new and existing markets. This is an important step for SciBase and I would like to welcome the new investors in our fight against skin cancer.
Tord Lendau, Chairman, comments:
We welcome our new shareholders and look forward to take the next step in the company’s development together with you. With the world’s best objective detection device for malignant melanoma, a strong management team, and backing from new capital, we will continue on-track towards profitability.
Viktor Drvota, board member by the mandate of SEB Venture Capital and SEB Pensionsstiftelse, comments:
As one of SciBase’s first and largest shareholders, it means a lot to see this considerable interest from both new institutional investors and private individuals. We participated significantly in the offering and as long-term shareholders we look forward to working with you to support the company in its commercial expansion.
Advisors
Pareto Securities is Sole Manager and Bookrunner in connection with the Offering. Hamilton Advokatbyrå is legal advisor to SciBase and Gernandt & Danielsson is legal advisor to Pareto Securities. Avanza is Selling Agent and Certified Adviser.
For further information please visit www.scibase.com or contact:
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 is a Swedish medical technology company founded in 1998 that has developed Nevisense, a point-of-care device for the accurate detection of malignant melanoma. Nevisense has emerged from more than 20 years of research at The Karolinska Institute in Stockholm and at SciBase. The device is designed to provide additional information when evaluating lesions with a suspicion of melanoma. Nevisense is based on a technology called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. The CE-marked system consists of an electrode on a hand-held probe connected to a small portable device performing the analysis and displaying the result.
A video describing the Nevisense method is available on: http://scibase.se/en/the-nevisense-product and further information is also available on www.scibase.com.
IMPORTANT NOTICE
This announcement is not and does not form a part of any offer for sale of securities.
Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Switzerland, South Africa or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.
Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.
In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.
Matters discussed in this announcement may constitute forward-looking statements. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
