2022-05-18 14:15

Today, the annual general meeting of 2022 was held in SciBase Holding AB (publ) (the “Company” or “SciBase”). Below follows a summary of the resolutions passed at the annual general meeting.

The annual general meeting resolved:

  • to adopt the profit and loss statement and the balance sheet and the group profit and loss statement and the group balance sheet for the financial year 2021;
  • that SEK 202,229,730 shall be carried forward in new account and that no dividend shall be paid;
  • to grant the board members and the CEO discharge from liability for the financial year 2021;
  • that the board of directors shall consist of five ordinary members without deputy members and that a registered accounting firm shall be elected as auditor;
  • that the fees payable to the board of directors for the period until the end of the next annual general meeting shall be SEK 200,000 for the chairman of the board and SEK 150,000 to each of the other ordinary board members (who are not employed by a larger shareholder in the Company) and that fees payable to the auditor is to be paid in accordance with approved invoices;
  • for the period until the end of the next annual general meeting, to re-elect Jvalini Dwarkasing, Diana Ferro, Matt Leavitt, Thomas Taapken and Tord Lendau as board members, to re-elect Tord Lendau as chairman of the board of directors and to re-elect the auditing firm PricewaterhouseCoopers AB (PwC) as auditor for the Company, with Magnus Lagerberg as auditor-in-charge;
  • to adopt principles for the appointment of a nomination committee (same principles as previous year); and
  • to authorize the board of directors to increase the share capital through issuance of new shares, warrants and/or convertible debentures. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company and may be made either in cash and/or by way of set-off or contribution in kind or otherwise be conditional. Through issuances resolved upon with support from the authorization – with deviation from the shareholders’ preferential rights – the number of shares issued, or number of shares created in connection with exercise of warrants or conversion of convertibles, shall correspond to not more than a 20 per cent dilution of the share capital and the number of shares and votes in the Company after such issue(s).  

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

The information was submitted, through the agency of the contact person set out above, for publication at the time stated by SciBase’s news distributor Cision upon publication of this press release.

About SciBase and Nevisense
SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.

Downloads

The aim of the study was to investigate the impact Electrical Impedance Spectroscopy (EIS) has on clinical decision-making for atypical pigmented skin lesions (PSLs) when compared to other diagnostic tools such as dermoscopy. Dermatologists, dermatology residents, and medical students completed an online survey eliciting their biopsy decisions for 24 atypical PSLs of varying histopathological diagnosis. Half of the lesions from each diagnosis group were presented as a clinical image with associated dermoscopic image and the other half as a clinical image with the corresponding EIS (Nevisense) score. The study showed a significant increase in diagnostic accuracy with Nevisense, especially for respondents who reported rarely using dermoscopy. This group showed the greatest improvement in sensitivity and specificity when using EIS compared to dermoscopy.  

The study results showed that EIS may complement dermoscopy by helping a broader range of providers make improved PSL diagnostic decisions. This will ultimately improve patient care and reduce the morbidity and mortality associated with melanoma.” says Dr Ungar at Icahn School of Medicine at Mount Sinai.

"The study further demonstrates the positive impact Nevisense has in the diagnostic process for clinicians when evaluating atypical pigmented skin lesions. The study showed that the addition of the Nevisense EIS data significantly increased the accuracy of clinicians. Clinician sensitivity increased from 66% to 75% and specificity from 40% to 70% which is a significant improvement. This further supports our market development efforts for the Nevisense EIS technology in the US”, says Simon Grant CEO SciBase.

The full article can be found here: https://www.jofskin.org/index.php/skin/article/view/1568/pdf

For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: simon.grant@scibase.com Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: ca@vatorsec.se About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.

2022-02-23 08:00

January 1 – December 31, 2021

The fourth quarter in figures

  • Net sales amounted to TSEK 3,925 (3,055).
  • The loss after tax amounted to TSEK 13,852 (9,839).
  • The loss per share amounted to SEK 0.20 (0.20).
  • The cash flow from current operations was negative in the amount of TSEK 11,709 (10,290).
  • The gross margin reached 52.8% (49.4%).
  • Electrode sales volume increased by 7% and reached 8,024 (7,492) units. Repeat sales of electrodes to existing customers increased by 12%.

The full year in figures

  • Net sales amounted to TSEK 11,727 (9,521).
  • The loss after tax amounted to TSEK 41,778 (34,989).
  • The loss per share amounted to SEK 0.67 (1.12).
  • The cash flow from current operations was negative in the amount of TSEK 39,501 (33,861).
  • The gross margin reached 56.1% (52.5%).
  • Electrode sales volume increased by 16% and reached 29,792 (25,686) units. Repeat sales of electrodes to existing customers increased by 12%.

Important events during the quarter

  • Overall sales increased by 28% (+34%, before currency effects). Covid-19 continues to affect sales and the market situation remains difficult to predict going forward, due to ongoing lockdowns and reduced marketing activities. The sales in the important US market increased within the area of skin cancer by 395% (in local currency by 415%).  Sales in Germany decreased by 18% (-14% in local currency).
  • A request for a Medicare payment assignment for the Nevisense procedure was submitted to National Government Services (NGS), the Medicare Administrative Contractor with carrier jurisdiction responsibility for New York and several other states.
  • SciBase received an order of ten additional Nevisense systems and electrodes valued at approximately KUSD 100 from Advanced Dermatology, P.C. (AdvDermPC) in New York City.
  • A nominating committee for the AGM 2022 was appointed.

Important events after the end of the period

  • A new study from the US supporting the use of Nevisense in diagnosing melanoma was published in “SKIN – The journal of cutaneous medicine”. The study shows that Nevisense provides valuable diagnostic guidance when evaluating atypical pigmented skin lesions.
  • SciBase announced a change in the Management team and a new head of Quality and Regulatory Affairs.

Financial overview   

Oct 1 – Dec 31Jan 1 – Dec 31
THE GROUP2021202020212020
Net sales, SEK ths3 9253 05511 7279 521
Gross margin, %52,8%49,4%56,1%52,5%
Equity/Asset ratio, %82,8%79,1%82,8%79,1%
Net indebtness, multiple0,210,260,210,26
Cash equivalents, SEK ths65 60741 42765 60741 427
Cashflow from operating activities, SEK ths-11 709-10 290-39 501-33 861
Earnings per share (before and after dilution), SEK-0,20-0,20-0,67-1,12
Shareholder’s equity per share, SEK1,030,961,161,50
Average number of shares, 000′68 47548 70760 82731 287
Number of shares at closing of period, 000′68 47554 78068 47554 780
Share price at end of period, SEK5,524,625,524,62
Number of sold electrodes, pieces8 0247 49229 79225 686
Average number of employees18171716

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 below, at 08.00 CET on February 23, 2022.

Contact person: Michael Colérus, CFO. +46 70 341 34 72

For more information, please contact: 
Simon Grant, CEO SciBase 
Phone: +46 72 887 43 99 
Email: simon.grant@scibase.com

Certified Advisor:
Vator Securities
Tel: +46 8 580 065 99
Email: ca@vatorsec.se  

About SciBase and Nevisense
SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.

Downloads

Listen to the DermaLive webinar (in German), presenting “INNOVATIVE DIAGNOSTIC TOOLS IN DERMATOLOGY” (and receive CME credits). On line on June 10th at 6 PM (CET), or afterwards as a video-on-demand. Presenters are Prof Julia Welzel, Dr Martina Ulrich, Prof Uwe Reinhold and Prof Cezmi Akdis, and morderator is Prof Thomas Dirschka.

Access through Streamed-up.com

I trust and hope that you are all well in these trying times. I’m very thankful that the team at SciBase has come through this unscathed so far. At the same time the landscape of our family life and our work life has undergone real changes in the recent months and I expect some of these changes are here to stay.

I, perhaps foolishly, thought that the activity levels would come down somewhat due to Covid-19. How wrong I was! We have been, and continue to be, very busy with a number of exciting projects.

But first a bit about our customers. Our two focus markets are Germany and the US – and in the US we have been until now concentrated in the Northeast and especially the New York area. Both have been significantly affected by the pandemic, and New York especially so. Many practices are opening now, but with reduced hours and reduced patient numbers. Aesthetic procedures such as botox are for the most part halted, but medical procedures such as skin cancer checks are returning.  It will take some time to return to a new normal, but the process to restart business is underway.

So what has kept us so busy? I’d like to run through some of the recent milestones and key projects we are working on.

Germany

Even though Covid-19 significantly affected the Q1 sales in Germany, we were extremely close to breakeven in Germany in Q1. This is due to a continuation of increased electrode use and sales we saw in 2019 and customer support cost savings. Nevisense 3.0 has dramatically improved usability for customers so that the test is easier to integrate into their patient workflow and this has driven test usage. On the other hand, Nevisense 3.0 requires much less training and support which has resulted in reduced staff costs. Breaking even in Germany is important because it means we can concentrate our investments on the other two parts of our strategy – the US and our new applications.

Progress in the US (finally!)

Within medtech there is a saying that `if you haven’t made it in the US, you haven’t made it’. It is a fantastic market once a product is established, but it is a notoriously tough market to penetrate and the reimbursement system is by far the most important and complex I have encountered. It has taken much longer than we had hoped, but we have reached a few key milestones.

Firstly, after an intensive 11 month process, the FDA has approved Nevisense 3.0. That it takes so long is to do with the fact that melanoma is considered a high -risk application and therefore the controls are stringent. So stringent in fact that we are the only device approved on the US market for melanoma detection. We think that Nevisense 3.0 is essential for our success in the US where patient throughput and efficiency are even more critical than Europe.

We were also very pleased to announce our collaboration partnership with the Advanced Dermatology and Cosmetic Surgery group (ADCS) last week. As the largest US network with over 150 clinics across the US, ADCS is a great partner and this is a significant opportunity for both companies. The driver for ADCS was best expressed by Matt Leavitt the CEO when he said `I want to bring more science into Dermatology’. They also have a company-wide focus on the early detection of skin cancer, so the fit with SciBase is excellent. More news will follow as we roll out the pilot phase in the coming weeks and months.

Otherwise, we saw sales traction and a good increase in usage from our US customers in Q4 and the beginning of Q1. With the effect of Covid, sales activities are reduced, so we have taken the opportunity to focus on our reimbursement process which continues to move forward, albeit more slowly than we would want.

Same technology, new products

The core of our products is combination of Electrical Impedance spectroscopy (EIS) and Artificial Intelligence (AI). Many companies talk about AI, but we are the first company within Dermatology and one of only a handful of companies globally to actually launch an AI-driven medical product into the market.  Around 100,000 patients have been successfully tested with our EIS and AI combination.

Development-wise we are working on two new product areas. Firstly, we are taking the same core electrode technology and EIS methodology and developing new AI algorithms that support new and exciting clinical applications. In other words, we are reusing the same basic measurement technology we have developed over the last 15 years and building new software analyses that provide clinical value in new clinical areas. Those two areas are non-melanoma skin cancer and skin barrier assessment. Both these applications have potential at least as large as melanoma and I see the skin barrier application especially as an exciting product. If you are interested in learning more about these areas I recommend that you visit our website or take a look at the following link from our AI partner Peltarion [https://peltarion.com/blog/applied-ai/scibase].

Secondly, we are very nearly complete with a revolutionary new product called Nevisense Go. Nevisense Go is a miniaturized, handheld version of Nevisense. The product provides completely self-contained measurement of EIS and AI-based evaluation of those measurements. The first application for Nevisense Go is the measurement of skin barrier function, but eventually all applications can be supported. The possibilities for this product are many. Being smaller, much less expensive and easier to use, Nevisense Go has real potential outside the dermatology clinic. We have a promising level of interest from industry for this product, and that will be our initial focus. I look forward to sharing more news on this as we near product completion.

So as you can see, there is a lot going on. Our goal is to do as much as we can now so that when the market comes back we are `firing on all cylinders’. We have a good team and I am really proud of what they continue to achieve under difficult circumstances.  Stay safe and I look forward to seeing you virtually or otherwise during the upcoming presentations of the company to support our new financing round. More information is available at [http://investors.scibase.se/en] if you are interested in becoming a shareholder.

Best Regards

Simon Grant, CEO

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: corp@avanza.se

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. 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 an FDA approval (PMA) 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 and abnormalities. SciBase is listed on First North Growth Market (“SCIB”). Further information is available at www.scibase.com.

SPECIAL PROCEDURE DUE TO THE SPREAD OF CORONAVIRUS

In light of the spread of the coronavirus, the board of directors has decided to implement certain precautionary measures for the extraordinary general meeting on 29 April 2020 in order to ascertain the well-being of the company’s shareholders’ as well as the opportunity for them to exercise their rights at the general meeting.

The Public Health Agency of Sweden has made the assessment that the risk for spread of the virus is very high and recommend avoidance of large gatherings and crowds. If one cannot avoid large gatherings, any time spent in such a situation should be kept at a minimum. For this reason, the timeframe for the general meeting will be kept a minimum, without restricting the shareholders’ rights. No food or beverage will be served in connection with the general meeting and representatives of the board of directors and the senior management of the company will not attend physically, but only through telephone.

Voting by proxy

Considering the current situation, the shareholders are asked to consider the possibility not to attend the meeting in person and instead attend by proxy. The Swedish Parliament has adopted a temporary legislation, which from 15 April 2020 provides Swedish limited companies increased possibilities to collect proxies to facilitate general meetings. With support of this temporary legislation, the board of directors of SciBase Holding AB (publ) has resolved to provide the shareholders with a special proxy form for exercise of voting rights. Instead of attending the general meeting in person, a shareholder may use the proxy form to authorize representatives of SciBase Holding AB (publ) and Setterwalls Advokatbyrå AB to vote for their shares at the general meeting in accordance with the shareholder’s instructions. The proxy form can be downloaded http://investors.scibase.se/en/extra-general-meeting-april-29-2020.