“The second quarter of the year saw an improvement in EBIT compared with recent quarters, continued high gross margins, strong growth and an exclusive collaboration and distribution agreement with US-based Thermo Fisher Scientific. Two new oncology products and one new transplant product were launched during the quarter. Our CLIA-certified laboratory in Atlanta was inaugurated and the first patient test was carried out in this laboratory.”

Fredrik Alpsten, CEO, Devyser

The quarter from April to June 2023

• Net sales amounted to SEK 37.7 million (30.9), corresponding to a 22.3% increase. Adjusted for exchange rate fluctuations, net sales increased by 12.6%.
• Gross profit totaled SEK 31.5 million (24.7), corresponding to a gross margin of 83.4% (79.9).
• Operating profit (EBIT) amounted to SEK -13.5 million (-12.6).
• Profit after tax totaled SEK -14.6 million (-14.3).
• Earnings per share before and after dilution amounted to SEK -0.90 (-0.90).
• Cash flow from operating activities stood at SEK -22.8 million (-7.9).

The period from January to June 2023

• Net sales amounted to SEK 77.2 million (61.3), corresponding to a 26.1% increase. Adjusted for exchange rate fluctuations, net sales increased by 17.3%.
• Gross profit totaled SEK 65.1 million (49.9), corresponding to a gross margin of 84.3% (81.4).
• Operating profit (EBIT) amounted to SEK -32.6 million (-17.9).
• Profit after tax totaled SEK -34.5 million (-20.4).
• Earnings per share before and after dilution amounted to SEK -2.14 (-1.29).
• Cash flow from operating activities stood at SEK -42.1 million (-15.3).

Important events during the quarter

Devyser launches first IVDR-certified product
In March, Devyser launched Compact, the company’s first IVDR-certified product. This is a rapid genetic test for the diagnosis of fetal chromosomal abnormalities, and is the first in its field to be approved in accordance with the IVDR, the new, more comprehensive, European regulatory framework that came into force in May 2022. The product was launched back in 2006 and is now the leading standard for prenatal diagnosis in several European countries.

Agreement with Thermo Fisher Scientific
Devyser signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific in April. The agreement gives Thermo Fisher exclusive rights to market Devyser’s NGS products for post-transplant follow-up in North America and Europe.

Winner of the Swecare Export Award 2023
Devyser received the Swecare Export Award 2023 in April. This prize is awarded to companies that “with creativity, commitment and scope put Swedish innovation in health and healthcare on the world map”. The award was presented by Minister for Social Affairs Jacob Forssmed.

CLIA certification of Devyser’s clinical laboratory
Devyser’s clinical testing laboratory in Atlanta was CLIA certified in May and inaugurated on June 30. The laboratory offers clinical testing services for hereditary diseases, oncology and post-transplant follow-up. The first commercial test was carried out at the end of June.

Annual General Meeting
At the Annual General Meeting in May, Mia Arnhult, Lars Höckenström, Fredrik Dahl, Pia Gideon and Fredrik Mattsson were re-elected as Board members. Mia Arnhult was re-elected as Chair of the Board.

Approval of Devyser’s RHD product in Canada
In June, Devyser was granted regulatory approval in Canada for non-invasive fetal RHD testing.

Devyser’s Deputy CEO and founder Ulf Klangby moves to an advisory role
In June, Devyser announced that Ulf Klangby would leave his position on July 1 and move to an advisory role as a consultant. From July 1, Devyser’s senior management will therefore consist of CEO Fredrik Alpsten, CFO Sabina Berlin, CCO Theis Kipling, COO Göran Rydin and CHRO Camilla Wiberg.

Launching of two new genetic tests for hereditary cancers
At the end of June, Devyser launched two new products, Devyser LynchFAP and Devyser BRCA PALB2. The products offer efficient, targeted and safe analysis of genes associated with an increased cancer risk, such as the genes implicated in Lynch syndrome and in breast and ovarian cancer.

Important events after the end of the quarter

IVDR approval of Devyser’s transplant products
Devyser’s new test for the detection of donor-derived cell-free DNA in blood samples from kidney transplant patients, and the company’s product for the screening and follow-up of stem cell transplant patients, were given IVDR approval in July.

Presentation

The report will be presented at an audiocast at 09:00 CET today. More information and links are available on https://ir.financialhearings.com/devyser-diagnostics-q2-2023.

This report and previous financial reports are available on the company’s webpage https://investors.devyser.com/en/reports-presentations.   

This information is information that Devyser Diagnostics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact persons below, on August 23, 2023, at 07:30 CET.

For more information, please contact:

Fredrik Alpsten, CEO
E-mail: fredrik.alpsten@devyser.com
Tel: +46 706 673 106

Sabina Berlin, CFO
E-mail: sabina.berlin@devyser.com
Tel: +46 739 519 502

About Devyser Diagnostics AB (publ)

Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 50 countries. Our products are used for complex genetic testing in the hereditary disease, oncology and transplant fields, to enable targeted cancer treatment, the diagnosis of a large number of genetic diseases, and transplant patient follow-up. Devyser’s products, and unique, patented solution requiring only one test tube, simplify genetic testing processes, improve sample throughput, minimize hands-on time and deliver rapid results. Our goal is for every patient to receive a correct diagnosis in the shortest possible time.

Devyser was founded in 2004 and is based in Stockholm, Sweden. The company has eight in-house sales offices in Europe and the US, and a CLIA laboratory in Atlanta, Georgia. In August 2022, Devyser's quality management system was certified according to the IVDR.

Devyser’s shares are listed on the Nasdaq First North Premier Growth Market Stockholm (ticker: DVYSR). The company’s Certified Adviser is Redeye AB.

For more information, visit www.devyser.com