Recent Insider Transactions • May 25
Chief Executive Officer recently bought kr290k worth of stock On the 22nd of May, Jan Wahlstrom bought around 3k shares on-market at roughly kr95.23 per share. This transaction amounted to 69% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Jan's only on-market trade for the last 12 months. Reported Earnings • Apr 28
First quarter 2026 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2026 results: EPS: kr0.17 (up from kr1.24 loss in 1Q 2025). Revenue: kr61.8m (up 13% from 1Q 2025). Net income: kr2.90m (up kr23.4m from 1Q 2025). Profit margin: 4.7% (up from net loss in 1Q 2025). The move to profitability was primarily driven by lower expenses. Revenue missed analyst estimates by 2.8%. Earnings per share (EPS) exceeded analyst estimates by 13%. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 37% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. New Risk • Apr 10
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr62m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company. 공시 • Apr 03
Devyser Diagnostics AB (publ), Annual General Meeting, May 06, 2026 Devyser Diagnostics AB (publ), Annual General Meeting, May 06, 2026, at 11:00 W. Europe Standard Time. Location: branningevagen 12, 120 54 arsta, Sweden Reported Earnings • Mar 30
Full year 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2025 results: kr0.51 loss per share (improved from kr3.75 loss in FY 2024). Revenue: kr250.5m (up 16% from FY 2024). Net loss: kr8.40m (loss narrowed 86% from FY 2024). Revenue missed analyst estimates by 1.7%. Earnings per share (EPS) exceeded analyst estimates by 36%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 9.9% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has only increased by 2% per year, which means it is significantly lagging earnings growth. Recent Insider Transactions • Mar 23
Chairman recently bought kr118k worth of stock On the 20th of March, Mia Arnhult bought around 2k shares on-market at roughly kr78.66 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Mia has been a buyer over the last 12 months, purchasing a net total of kr1.7m worth in shares. Reported Earnings • Feb 13
Full year 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2025 results: kr0.51 loss per share (improved from kr3.75 loss in FY 2024). Revenue: kr250.5m (up 16% from FY 2024). Net loss: kr8.40m (loss narrowed 86% from FY 2024). Revenue missed analyst estimates by 1.7%. Earnings per share (EPS) exceeded analyst estimates by 36%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 17% per year whereas the company’s share price has increased by 13% per year. Recent Insider Transactions • Nov 13
Chairman recently bought kr1.6m worth of stock On the 7th of November, Mia Arnhult bought around 14k shares on-market at roughly kr110 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Mia has been a buyer over the last 12 months, purchasing a net total of kr2.3m worth in shares. Reported Earnings • Nov 06
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: kr0.17 loss per share (improved from kr1.41 loss in 3Q 2024). Revenue: kr56.4m (up 16% from 3Q 2024). Net loss: kr2.80m (loss narrowed 88% from 3Q 2024). Revenue missed analyst estimates by 9.5%. Earnings per share (EPS) were also behind analyst expectations. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 22% per year, which means it is tracking significantly ahead of earnings growth. Buy Or Sell Opportunity • Nov 03
Now 21% undervalued after recent price drop Over the last 90 days, the stock has fallen 20% to kr123. The fair value is estimated to be kr156, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 25% over the last 3 years. Earnings per share has declined by 8.6%. Reported Earnings • Jul 22
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: EPS: kr0.079 (up from kr1.41 loss in 2Q 2024). Revenue: kr67.4m (up 27% from 2Q 2024). Net income: kr1.30m (up kr24.2m from 2Q 2024). Profit margin: 1.9% (up from net loss in 2Q 2024). The move to profitability was primarily driven by higher revenue. Revenue exceeded analyst estimates by 8.8%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has increased by 29% per year, which means it is well ahead of earnings. 공시 • Jun 30
Devyser Launches Genomic Blood Typing Assay Devyser announced the global launch of, a next-Devyser Genomic Blood Typing generation sequencing (NGS)-based solution that redefines molecular blood group research. Developed exclusively, this all-in-one assay enables comprehensive genetic blood typing-covering red blood cell (RBC), human platelet antigen (HPA), and human neutrophil antigen (HNA) systems-in a single, streamlined test. Designed to address the complexities of blood group analysis in transfusion and transplantation research, Devyser Genomic Blood Typed offers high-resolution results with unprecedented workflow simplicity and software-guided interpretation. Simplifying complexity in blood group research. Traditional serological methods often struggle with weak antigen expression, rare variants, or ambiguous results-particularly across diverse ethnic backgrounds. Devyser Genomic Blood typing fills these gaps by delivering clear and accurate insights into blood antigen profiles at the genetic level. Advancing molecular blood typing in research settings. Devyser Genomic blood typing empowers research laboratories, transfusion centers, and transplant programs to move beyond the limitations of serology. Whether identifying rare blood types or studying immune compatibility, the solution offers precision and reproducibility that elevate scientific confidence. Reported Earnings • Apr 07
Full year 2024 earnings: EPS misses analyst expectations Full year 2024 results: kr3.75 loss per share (further deteriorated from kr3.31 loss in FY 2023). Revenue: kr216.9m (up 28% from FY 2023). Net loss: kr61.5m (loss widened 15% from FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 6.8%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has increased by 7% per year, which means it is well ahead of earnings. Reported Earnings • Feb 14
Full year 2024 earnings: EPS misses analyst expectations Full year 2024 results: kr3.75 loss per share (further deteriorated from kr3.31 loss in FY 2023). Revenue: kr216.9m (up 28% from FY 2023). Net loss: kr61.5m (loss widened 15% from FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 4.2%. Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has increased by 18% per year, which means it is well ahead of earnings. 공시 • Feb 04
Devyser Launches A New Updated NGS Assay to Simplify Thalassemia Testing Devyser has launched Devyser Thalassemia v2, a next-generation sequencing (NGS) solution designed to further simplify genetic testing. The improved technology, will help broader screening for thalassemia with greater precision in detecting structural variants, saving time and ensuring better results for researchers worldwide. This product will allow laboratories to achieve rapid, comprehensive results, reducing workflow complexity and enabling efficient genetic profiling through a single assay. Devyser Thalassemia v2 offers a streamlined protocol with minimal hands-on time, empowering labs to deliver reliable and reproducible results consistently. Devyser Thalassemia v2 is currently available globally as a Research Use Only (RUO) product. Board Change • Jan 17
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Thomas Eklund was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 공시 • Jan 16
Devyser Diagnostics Announces CEO Changes Devyser Diagnostics announced Fredrik Alpsten and the Board of Directors have now reached an agreement that he will leave his position as CEO of Devyser. Devyser's Board of Directors has initiated the recruitment of a new CEO. Fredrik Dahl, PhD in Molecular Medicine, currently a board member and well acquainted with the company, has been appointed acting CEO. Fredrik Dahl holds a PhD in Molecular Medicine from Uppsala University and has done research at Stanford University in DNA technology. After his studies at Stanford, Fredrik worked in California at a pioneering research company in DNA sequencing. Thereafter he moved back to Sweden and co-founded Halo Genomics, which was sold to the American Agilent Technologies, and co-founded Vanadis Diagnostics, which was sold to the American diagnostics company PerkinElmer (now Revvity). Fredrik Dahl thus has extensive international experience in various management roles from global research and diagnostics companies. Fredrik Dahl will remain as a member of Devyser's Board of Directors. 공시 • Dec 02
Devyser Achieves Class D IVDR Approval for its RHD Product Devyser has received IVDR approval for its non-invasive fetal RHD screening product. This marks the first approval of a Class D product, the highest risk class under the new, comprehensive European regulation that came into force in May 2022. This approval confirms that Devyser's RHD product meets the stringent safety, efficacy, and quality requirements. Devyser RHD is a highly sensitive CE-IVD labelled QPCR test to conduct accurate non-invasive screening for fetal RHD that helps clinicians avoid untargeted and unnecessary treatment. 공시 • Nov 02
Devyser Diagnostics AB (publ), Annual General Meeting, May 14, 2025 Devyser Diagnostics AB (publ), Annual General Meeting, May 14, 2025. Reported Earnings • Nov 01
Third quarter 2024 earnings: EPS and revenues miss analyst expectations Third quarter 2024 results: kr1.41 loss per share (further deteriorated from kr0.37 loss in 3Q 2023). Revenue: kr48.7m (up 4.3% from 3Q 2023). Net loss: kr23.2m (loss widened 287% from 3Q 2023). Revenue missed analyst estimates by 12%. Earnings per share (EPS) also missed analyst estimates by 10.0%. Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Sweden. New Risk • Oct 22
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.2% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Major Estimate Revision • Sep 23
Consensus EPS estimates fall by 18% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -kr2.65 to -kr3.13 per share. Revenue forecast of kr230.9m unchanged since last update. Biotechs industry in Sweden expected to see average net income growth of 9.2% next year. Consensus price target up from kr128 to kr150. Share price rose 5.5% to kr125 over the past week. Recent Insider Transactions • Jul 26
Chief Executive Officer recently bought kr324k worth of stock On the 23rd of July, Fredrik Alpsten bought around 3k shares on-market at roughly kr108 per share. This transaction amounted to 1.5% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth kr11m. Despite this recent buy, Fredrik has been a net seller over the last 12 months, reducing personal holdings by kr4.3m. Reported Earnings • Jul 24
Second quarter 2024 earnings released: kr1.41 loss per share (vs kr0.90 loss in 2Q 2023) Second quarter 2024 results: kr1.41 loss per share (further deteriorated from kr0.90 loss in 2Q 2023). Revenue: kr53.2m (up 41% from 2Q 2023). Net loss: kr22.9m (loss widened 57% from 2Q 2023). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Sweden. New Risk • Jul 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Recent Insider Transactions • Jun 22
Chief Executive Officer recently sold kr5.5m worth of stock On the 19th of June, Fredrik Alpsten sold around 51k shares on-market at roughly kr109 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Fredrik has been a net seller over the last 12 months, reducing personal holdings by kr181k. 공시 • May 15
Devyser Diagnostics AB (publ) Appoints Thomas Eklund as Member of the Board of Directors Devyser Diagnostics AB (publ) announced that at the Annual General Meeting held on 14 May 2024 Thomas Eklund was elected as new member of the Board of Directors for the same period. Recent Insider Transactions • May 10
Chief Executive Officer recently bought kr299k worth of stock On the 8th of May, Fredrik Alpsten bought around 3k shares on-market at roughly kr99.63 per share. This transaction amounted to 1.5% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Fredrik has been a buyer over the last 12 months, purchasing a net total of kr685k worth in shares. Reported Earnings • May 08
First quarter 2024 earnings released: kr0.75 loss per share (vs kr1.23 loss in 1Q 2023) First quarter 2024 results: kr0.75 loss per share (improved from kr1.23 loss in 1Q 2023). Revenue: kr50.7m (up 28% from 1Q 2023). Net loss: kr12.2m (loss narrowed 39% from 1Q 2023). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Sweden. 공시 • Apr 26
Devyser Receives IVDR Approval for Post-Transplant Monitoring Software Devyser has received IVDR approval for Advyser Solid organs, its software for the post-transplant product One Lambda Devyser Accept cfDNA. This is Devyser's first European approval for post-transplant monitoring software under the new, more comprehensive IVD regulation that came into force in May 2022, and it confirms Devyser software meets the established safety, efficacy, and quality requirements. Advyser Solid organs is an IVD software for monitoring donor-derived cell-free DNA (dd-cfDNA) in patients following kidney transplantation. The software is intended for use with One Lambda Devyser accept cfDNA, a novel NGS test for detecting dd-cfDNA in blood samples from kidney transplant patients. The assay received IVDR approval in 2023. The product mentioned is CE-IVD marketed but not FDA-cleared. Availability in each country depends on local regulatory marketing authorization status. Reported Earnings • Apr 14
Full year 2023 earnings: EPS misses analyst expectations Full year 2023 results: kr3.31 loss per share (further deteriorated from kr2.89 loss in FY 2022). Revenue: kr169.3m (up 34% from FY 2022). Net loss: kr53.6m (loss widened 17% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 27%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Sweden. Major Estimate Revision • Mar 10
Consensus estimates of losses per share improve by 66% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from kr223.8m to kr245.2m. EPS estimate increased from -kr1.50 per share to -kr0.517 per share. Biotechs industry in Sweden expected to see average net income growth of 14% next year. Consensus price target broadly unchanged at kr115. Share price was steady at kr90.20 over the past week. 공시 • Feb 29
Devyser Diagnostics AB (publ) Announces Study Publication Demonstrating dd-cfDNA Detection in Dual Donor Kidney Transplant Patient Devyser Diagnostics AB (publ) announced an article titled "Detection of donor- derived cell-free DNA (dd-cfDNA) in the setting of multiple kidney transplantations" was published in the journal, Frontiers in Immunology. This study was done in collaboration with the Departments of Immunology and Nephrology at the University of Zurich, including Dr. Jakob Nilsson using the One Lambda Devyser Accept cfDNA assay. This is the first report on the use of an NGS assay to detect dd-cfDNA from multiple kidney transplants to monitor organ damage following transplantation. dd-cfDNA is used as a marker for monitoring organ damage and rejection following transplantation. Successfully differentiating dd-cfDNA in patients who have received a dual donor kidney transplant, or a sequential transplant, is a significant challenge in the accurate monitoring of such patients. This study showed that transplant patients had detectable cfDNA from multiple donor grafts and One Lambda Devyser Accept cfDNA was able to maintain a high sensitivity. The authors concluded that the results have the potential to influence clinical decision-making. Reported Earnings • Feb 22
Full year 2023 earnings: EPS misses analyst expectations Full year 2023 results: kr3.31 loss per share (further deteriorated from kr2.89 loss in FY 2022). Revenue: kr169.3m (up 34% from FY 2022). Net loss: kr53.6m (loss widened 17% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 27%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Sweden. New Risk • Feb 11
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: kr1.2m This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. This is currently the only risk that has been identified for the company. 공시 • Jan 29
Devyser Diagnostics AB (Publ) Announces Michael Uhlin, CSO Joins Management Team as of February 1, 2024 Devyser Diagnostics AB (publ) announcing the strengthening and expanding of its management team as of February 1, 2024. Michael Uhlin, who has been Devyser’s CSO since the fall of 2023, will join the management team, with responsibility for development/innovation, including bioinformatics, clinical affairs and Devyser Genomic Laboratories, Devyser’s CLIA-certified laboratory. He will report to Devyser’s CEO, Fredrik Alpsten. Michael Uhlin, who also holds a professorship at Karolinska Institutet, has solid experience in the global life sciences sector, in both academia and industry, where he has held various senior positions. He has long been engaged in translational research and development in areas relevant to Devyser’s activities. 공시 • Jan 12
Devyser Diagnostics AB (publ) to Report Fiscal Year 2023 Final Results on Apr 11, 2024 Devyser Diagnostics AB (publ) announced that they will report fiscal year 2023 final results at 9:00 AM, Central European Standard Time on Apr 11, 2024 Recent Insider Transactions • Nov 16
Chief Executive Officer recently bought kr1.5m worth of stock On the 10th of November, Fredrik Alpsten bought around 25k shares on-market at roughly kr60.40 per share. This transaction amounted to 15% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Fredrik has been a buyer over the last 12 months, purchasing a net total of kr386k worth in shares. Reported Earnings • Nov 10
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: kr0.37 loss per share (improved from kr0.55 loss in 3Q 2022). Revenue: kr46.7m (up 50% from 3Q 2022). Net loss: kr6.00m (loss narrowed 32% from 3Q 2022). Revenue exceeded analyst estimates by 13%. Earnings per share (EPS) also surpassed analyst estimates by 42%. Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Sweden. 공시 • Nov 09
Devyser Diagnostics AB (publ), Annual General Meeting, May 14, 2024 Devyser Diagnostics AB (publ), Annual General Meeting, May 14, 2024. Major Estimate Revision • Sep 04
Consensus estimates of losses per share improve by 29% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has improved. 2023 revenue forecast increased from kr160.8m to kr170.7m. EPS estimate increased from -kr4.60 per share to -kr3.26 per share. Biotechs industry in Sweden expected to see average net income growth of 6.4% next year. Consensus price target down from kr121 to kr117. Share price was steady at kr73.00 over the past week. Recent Insider Transactions • Sep 03
Independent Director recently bought kr1.1m worth of stock On the 31st of August, Fredrik Dahl bought around 15k shares on-market at roughly kr72.90 per share. This transaction amounted to 78% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought kr1.2m more in shares than they have sold in the last 12 months. Major Estimate Revision • Aug 30
Consensus revenue estimates fall by 11% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from kr180.1m to kr160.8m. Forecast losses increased from -kr3.44 to -kr4.60 per share. Biotechs industry in Sweden expected to see average net income growth of 3.6% next year. Consensus price target down from kr128 to kr122. Share price fell 3.7% to kr73.00 over the past week. New Risk • Aug 25
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr60m Forecast net loss in 2 years: kr1.7m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. Reported Earnings • Aug 23
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: kr0.90 loss per share (further deteriorated from kr0.90 loss in 2Q 2022). Revenue: kr37.7m (up 22% from 2Q 2022). Net loss: kr14.6m (loss widened 2.1% from 2Q 2022). Revenue missed analyst estimates by 11%. Earnings per share (EPS) exceeded analyst estimates by 26%. Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 24% growth forecast for the Biotechs industry in Sweden. 공시 • Jul 18
Devyser's Ngs Products for Monitoring of Kidney and Stem Cell Transplanted Patients Receive IVDR Approvals Devyser's novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplanted patients fulfill IVDR requirements in Europe. These tests are the first post-transplant monitoring NGS products to be approved under the new, more comprehensive regulation that came into force in May 2022 and confirm Devyser's two NGS products meet the established safety, efficacy, and quality requirements. Thermo Fisher Scientific, Devyser's commercialization partner for these products, can now market and sell the regulatory-approved products in all European markets, in accordance with their launch plans. The IVDR approved products are One Lambda Devyser Chimerism, for early detection of mixed chimerism in stem cell transplanted patients, and One Lambda Devyser Accept cfDNA, a novel test for the detection of donor-derived cell-free DNA in blood samples from kidney transplant patients. From May 26, 2022, all new medical devices to be sold in Europe must comply with the new IVD Regulation (IVDR) to ensure the highest level of public health protection. The transplantation market is growing rapidly due to a larger aging population and higher incidence of chronic diseases. However, there is a shortage of organs globally, and many patients are currently on waiting lists for new organs. Kidney transplantation is the most common organ transplantation. End-stage renal disease (ESRD) affects 2 million people globally, and the most common causes of kidney disease are type 1 diabetes, high blood pressure, and kidney inflammation. In 2021 approximately 92,000 kidney transplantations were performed globally. Compared to dialysis, kidney transplantation provides higher patient survival and superior quality of life. From a health economic perspective, it is also more favourable. 공시 • Jun 29
Devyser Launches Two New Genetic Testing Solutions for Hereditary Cancer Devyser announced the launch of two new products, Devyser LynchFAP and Devyser BRCA PALB2. These kits offer efficient, targeted, and confident analysis of genes associated with increased cancer risk, such as those involved in Lynch syndrome, and in breast and ovarian cancers. Devyser LynchFAP provides a comprehensive solution to analyze PMS2 and 9 other genes associated with hereditary colorectal cancer syndromes. Devyser LynchFAP is designed to overcome one of the greatest challenges for Lynch syndrome genetic testing - the localization of genetic variants to PMS2 and its pseudogene PMS2CL. Devyser LynchFAP is the first commercial library prep kit to allow this specific analysis of the PMS2 gene. With a simple next-generation sequencing (NGS) workflow, this test and dedicated software enable users to disentangle complex genetics with an intuitive and easy-to-use solution. Devyser is proud to add Devyser LynchFAP to its expanding oncology offering. Colorectal cancer is the third most common cancer worldwide. 10-20% of cases are due to hereditary cancer syndromes such as Lynch syndrome. Having a hereditary cancer syndrome significantly increases an individual's risk of developing colorectal cancer, among multiple other cancer types. It is estimated that 1 in 300 individuals carry mutations in DNA mismatch repair genes, such as those associated with Lynch syndrome. The challenge is that many people, up to 95% in certain regions, do not know that they carry these mutations. Devyser BRCA PALB2 provides a targeted solution with the simplest commercially available workflow for crucial genetic information related to breast and ovarian cancer. This kit allows for the sequencing of genetic variants in BRCA1, BRCA2, and PALB2, the three most significant genes increasing breast cancer risk. The simplified workflow of Devyser BRCA PALB2 enables fast laboratory implementation and streamlines two applications in one solution – the analysis of genetic variants in DNA from human blood and tumor tissue. Devyser is committed to advancing genetic testing technologies to improve patient outcomes and contribute to the field of personalized medicine. With the launch of Devyser LynchFAP and Devyser BRCA PALB2, the company is taking a significant step towards achieving its mission of enabling early detection and targeted interventions for individuals at risk of hereditary cancer syndromes. 공시 • Jun 06
Devyser Announces its Deputy CEO and Founder Ulf Klangby Moves to Advisory Role Devyser announced that its Deputy CEO and founder Ulf Klangby will leave his position within the company for an advisory role as a consultant as of July 1, 2023. Ulf Klangby will leave his operational role as part of the group management team and instead support the company as a consultant. In his consulting role, Ulf will support the company in areas including business development, patent-related issues and the evaluation of future products and technologies. Ulf Klangby founded Devyser in 2004 together with Anders Hedrum and Dan Hauzenberger, and was the company's CEO from 2004 to 2020 and a member of the company's Board of Directors from 2004 to 2021. As of July 1, 2023, the company's group management team will comprise Fredrik Alpsten, CEO, Sabina Berlin, CFO, Theis Kipling, CCO, Göran Rydin, COO, and Camilla Wiberg, CHRO. Recent Insider Transactions • May 21
Chief Executive Officer recently bought kr105k worth of stock On the 17th of May, Fredrik Alpsten bought around 1k shares on-market at roughly kr78.40 per share. This transaction amounted to 1.0% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Fredrik's only on-market trade for the last 12 months. 공시 • May 12
Devyser Diagnostics AB Announces Approval of Devyser's RHD Product in Canada Devyser Diagnostics AB announced that its product for non-invasive fetal RHD testing has been granted regulatory approval in Canada. Devyser already has a contract with Canada's Héma-Québec to deliver RHD tests. The product approval by Health Canada means that it meets the established safety, efficacy and quality requirements for products marketed and sold in Canada. Devyser has had MDSAP approval for the quality management system since 2020, which is a requirement for product registration in Canada. The RHD test is Devyser's first approved Class III IVD product in Canada. The regulatory approval application was submitted as part of the procurement process connected with the company's 2022 contract with Héma-Québec, an exclusive supplier of blood products in the Quebec region. The contract will initially run for three years, and may potentially be extended for another two years. The total potential order value amounts to just over SEK 16 million. Devyser's RHD product is used by diagnostic laboratories for the non-invasive determination of the RHD status of fetuses from maternal blood samples. It is important to determine the RHD status of fetuses for pregnant women who are RHD negative to avoid hemolytic disease, a condition that can be life-threatening for newborns. Hemolytic disease can be prevented through the early determination of fetal RHD status and prophylactic treatment during pregnancy. Reported Earnings • May 10
First quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2023 results: kr1.23 loss per share (further deteriorated from kr0.39 loss in 1Q 2022). Revenue: kr39.5m (up 30% from 1Q 2022). Net loss: kr19.9m (loss widened 226% from 1Q 2022). Revenue exceeded analyst estimates by 1.2%. Earnings per share (EPS) missed analyst estimates by 68%. Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 24% growth forecast for the Biotechs industry in Sweden. Major Estimate Revision • Mar 04
Consensus EPS estimates upgraded to kr1.89 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -kr3.33 to -kr1.89 per share. Revenue forecast steady at kr177.1m. Biotechs industry in Sweden expected to see average net income decline 11% next year. Consensus price target broadly unchanged at kr115. Share price rose 3.0% to kr78.80 over the past week. Reported Earnings • Feb 22
Full year 2022 earnings: EPS misses analyst expectations Full year 2022 results: kr2.89 loss per share (further deteriorated from kr1.85 loss in FY 2021). Revenue: kr126.6m (up 35% from FY 2021). Net loss: kr46.0m (loss widened 122% from FY 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 15%. Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Sweden. Major Estimate Revision • Feb 21
Consensus EPS estimates fall by 1,989% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from kr185.6m to kr176.1m. Losses expected to increase from kr0.014 per share to kr0.29. Biotechs industry in Sweden expected to see average net income decline 23% next year. Consensus price target down from kr119 to kr114. Share price was steady at kr74.00 over the past week. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Pia Magrhild Gideon was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 11
Third quarter 2022 earnings released: kr0.55 loss per share (vs kr0.87 loss in 3Q 2021) Third quarter 2022 results: kr0.55 loss per share (improved from kr0.87 loss in 3Q 2021). Revenue: kr31.2m (up 27% from 3Q 2021). Net loss: kr8.80m (loss narrowed 17% from 3Q 2021). Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 26% growth forecast for the Biotechs industry in Sweden. 공시 • Nov 11
Devyser Diagnostics AB (publ) to Report Fiscal Year 2023 Results on Feb 20, 2024 Devyser Diagnostics AB (publ) announced that they will report fiscal year 2023 results on Feb 20, 2024 공시 • Nov 02
Devyser Diagnostics AB (publ) Appoints John Murad as Vice President and General Manager in the US Devyser Diagnostics AB (publ) announces the appointment of John Murad as Vice President and General Manager for Devyser US. He will be responsible for all Devyser operations in North America. John Murad is joining Devyser on November 1 and reports to Devyser's CCO Theis Kipling. John Murad has over 20 years' experience from senior management positions in health care, including National Sales Director at Veracyte and Marketing Director at the Abbott point of care lab diagnostics division. John has an accomplished profile with solid experience across pharma and diagnostics as well as across marketing, sales and leadership from similar growth focused roles as the one he will now take up at Devyser making him ideal for the role. Major Estimate Revision • Aug 31
Consensus EPS estimates fall by 66% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from kr135.2m to kr131.6m. Losses expected to increase from kr1.33 per share to kr2.21. Biotechs industry in Sweden expected to see average net income growth of 8.6% next year. Consensus price target broadly unchanged at kr129. Share price fell 3.2% to kr67.75 over the past week. Reported Earnings • Aug 26
Second quarter 2022 earnings released: kr0.90 loss per share (vs kr0.94 loss in 2Q 2021) Second quarter 2022 results: kr0.90 loss per share. Revenue: kr30.9m (up 75% from 2Q 2021). Net loss: kr14.3m (loss widened 74% from 2Q 2021). Over the next year, revenue is forecast to grow 47%, compared to a 208% growth forecast for the Biotechs industry in Sweden. 공시 • Aug 19
Devyser Diagnostics AB (Publ) Appoints Camilla Wiberg as Chief HR Officer Devyser Diagnostics AB (publ) announced on September 1, Camilla Wiberg will take up the newly established position as Chief HR Officer (CHRO) and become a member of the company group management. In the company's current growth phase, HR is an important, central function needed to support and develop the organization. Camilla will lead this work in her new role. Camilla Wiberg has nearly 20 years' experience working in strategic and operational HR in a number of industries. For the past five years she has run her own company, where she has held various positions including interim HR Manager and organization development roles. She previously worked in HR at companies such as Orkla Care AB and Avanade. Following Camilla Wiberg's appointment, the company's group management team will comprise Fredrik Alpsten, CEO, Sabina Berlin, CFO, Theis Kipling, CCO, Göran Rydin, COO, Ulf Klangby, Deputy CEO, and Camilla Wiberg, CHRO. Board Change • May 19
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Pia Magrhild Gideon was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 공시 • May 12
Devyser Diagnostics AB (publ), Annual General Meeting, May 11, 2022 Devyser Diagnostics AB (publ), Annual General Meeting, May 11, 2022.