Interim Report January 1 – December 31, 2016
All-time high Sales for a quarter and the first shipment of our new product Nevisense View
The fourth quarter in figures
- Net sales amounted to TSEK 1,935 (1,181).
- The loss after tax amounted to TSEK 14,623 (11,154).
- The loss per share amounted to SEK 1.77 (1.35).
- The cash flow from current operations was negative in the amount of TSEK 13,032 (13,864).
- Significant margin improvement with gross margin increasing to 35.0% in Q4 (18.4%).
The full year in figures
- Net sales amounted to TSEK 6,436 (4,151).
- The loss after tax amounted to TSEK 53,086 (41,532).
- The loss per share amounted to SEK 6,41 (6.01).
- The cash flow from current operations was negative in the amount of TSEK 47,850 (46,588).
- Significant margin improvement with gross margin increasing to 34.5% (2.5%).
Important events during the quarter
- Our primary market Germany continues to show good growth with sales in value up by 54% and electrode sales volume up by 93% in the quarter.
- Significant resources invested in the PMA process, with continued progress. Ongoing work to provide replies to feedback from the FDA within several areas.
- A nominating committee has been appointed for the AGM 2017.
- In the period the management team was strengthened with Niklas Jakobsson, responsible for QA and regulatory issues and with Anna Danström head of manufacturing and logistics.
- The semi-automated electrode production process now validated.
- First delivery of Nevisense View in the period.
Important events after the end of the period
- DermoScan and SciBase agree to co-promote an integrated solution for digital dermoscopy and Nevisense.
|Oct 1 - Dec 31||Jan 1 - Dec 31|
|Net sales, SEK ths||1 935||1 181||6 436||4 151|
|Gross margin, %||35,0%||18,4%||34,5%||2,5%|
|Equity/Asset ratio, %||90,8%||95,1%||90,8%||95,1%|
|Net indebtness, multiple||0,10||0,05||0,10||0,05|
|Cash equivalents, SEK ths||84 955||133 736||84 955||133 736|
|Cashflow from operating activities, SEK ths||-13 032||-13 864||-47 850||-46 588|
|Earnings per share (before and after dilution), SEK*||-1,77||-1,35||-6,41||-6,01|
|Shareholder's equity per share, SEK*||11,19||17,59||11,19||21,09|
|Average number of shares, 000'*||8 285||8 285||8 285||6 910|
|Number of shares at closing of period, 000'*||8 285||8 285||8 285||8 285|
|Share price at end of period, SEK||19,00||31,00||19,00||31,00|
|Average number of employees||23||15||21||14|
|*Adjusted for in May 2015 performed reversed split, 40:1|
Comment by CEO Simon Grant
In the last quarter we were happy to see continued sales growth, driven by increased Nevisense usage. Compared to the same period 2015 our sales increased by 64 percent and reached MSEK 1.9, which is a new all-time high. We also sold 5,600 electrodes, an increase of 106 percent. The sales for the full year 2016 amounted to over MSEK 6.4, which is an increase with 55 percent compared to 2015. The volume of sold electrodes (tests) increased by 87 percent to 15,200. Germany continues to be our growth engine and it is encouraging to see that we have a growing number of high-volume users there. As you know, our business model requires an initial device sale but the potential lies in the sale of single-patient electrodes when the device is used.
The first Nevisense View delivered
In December Nevisense View, a new device combining our EIS-method with the documentation of clinical images, became commercially available. With Nevisense View it is possible to import clinical and dermoscopic images of lesions and store them together with patient data and the EIS test results. For clinicians, this can have significant benefits. It can improve workflow, facilitate full documentation of suspicious lesions and help monitor difficult to diagnose lesions. In December we delivered the first Nevisense View to Belgium. Since then we have also sold units in Sweden and we see an increasing interest from these as well as from other markets, including Germany.
As part of the release of Nevisense View, we also released a major update of Nevisense itself. This included both an update in the Nevisense hardware but also significant improvements in the system software. We have, for example, added inbuilt network connectivity (Wi-Fi and Ethernet), improved patient data management and the body map, and added follow-up functionality.
Germany is the engine but there are other interesting markets
Germany is, as you know, our largest and most important market and we continue to grow at a rapid pace there. During the quarter sales increased by 54 percent and the volume of sold electrodes by 93 percent compared to the same period 2015. We see now over one thousand patients tested each month in Germany. We also see a growing number of clinics with more than one system, which is positive as it is a sign that they see the benefits of Nevisense. In total we now have fifteen customers in Germany with two, three or even four Nevisense systems. The German market success is driven by market conditions and our direct sales presence. There are many private dermatology clinics, there is reimbursement coverage for EIS-measurements and good acceptance for the method.
In January 2017 we entered into a co-promotion agreement with DermoScan GmbH. This co-operation provides an opportunity to reach Dermoscan’s customer base of several hundred clinics. We will be able to offer an integrated solution for each other’s products and that will both improve workflow and save time for clinics. DermoScan will market Nevisense towards both their existing as well as new customers with Germany as the initial focus.
With Nevisense View we see improved opportunities for our offer on the Belgian and Swiss markets and we will subsequently increase our efforts there. We also see and increased interest in Nevisense View in Sweden.
In the USA the process to achieve a PMA approval continues to move forward. During the period we have provided additional complementary information, as is the normal process. We receive on-going feedback and we stand by our hope that we will receive an FDA approval by the end of the second quarter 2017.
Moving forward in electrode production
In the period we finalized the validation of the semi-automated production process, which now is ready for implementation. We now have a short-term focus on increasing production capacity and yield.
We’re now looking forward to a spring where sales and the on-going PMA process will continue to be our main priorities. We will work to support the sales channels as they introduce Nevisense View and we are also looking forward to our cooperation with DermoScan. We believe that the cooperation offers good opportunities for us to reach new groups of customers and increase the knowledge of SciBase, Nevisense and the EIS-method.
Simon Grant, CEO
The Year-end report 2016 is found in its entirety below
For further information please visit www.scibase.com or contact:
Simon Grant, CEO
Tel: +46 72 887 43 99
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on February 17, 2017.
Michael Colérus, CFO
Tel: +46 70 341 34 72
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.