Major Estimate Revision • May 29
Consensus revenue estimates increase by 19% The consensus outlook for revenues in fiscal year 2026 has improved. 2026 revenue forecast increased from €3.36m to €4.00m. Forecast losses expected to reduce from -€0.363 to -€0.32 per share. Medical Equipment industry in Sweden expected to see average net income growth of 43% next year. Consensus price target broadly unchanged at kr72.72. Share price rose 4.5% to kr60.10 over the past week. New Risk • May 25
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.0% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 4.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€25m net loss in 2 years). Share price has been volatile over the past 3 months (9.0% average weekly change). Revenue is less than US$5m (€2.2m revenue, or US$2.5m). Announcement • May 23
Implantica AG, Annual General Meeting, Jun 10, 2026 Implantica AG, Annual General Meeting, Jun 10, 2026, at 14:00 W. Europe Standard Time. Location: hotel kommod, industriering 14, 9491 ruggell, liechtenstein, Liechtenstein Reported Earnings • May 22
First quarter 2026 earnings: EPS and revenues exceed analyst expectations First quarter 2026 results: €0.06 loss per share (further deteriorated from €0.01 loss in 1Q 2025). Net loss: €4.26m (loss widened 57% from 1Q 2025). Revenue exceeded analyst estimates by 45%. Earnings per share (EPS) also surpassed analyst estimates by 26%. Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has increased by 52% per year, which means it is tracking significantly ahead of earnings growth. Announcement • May 21
Implantica AG Submits Final Response To FDA In The PMA Application For RefluxStop For U.S. Market Approval Implantica AG (publ.) announced that it has submitted its final response to the U.S. Food and Drug Administration (FDA) feedback regarding Module 3 of the Premarket Approval (PMA) application for RefluxStop. The submission includes Implantica's responses to FDA's remaining questions and requests, including the completion of additional testing requested by the Agency following the previously announced 100-Day Meeting, review of all three PMA modules, and multiple pre-approval inspections conducted by FDA. The six preapproval inspections, including manufactoring sites, Quality System, and BIMO (clinical trial inspections), were all successfully concluded as reported in the closing meetings. RefluxStop is a unique surgical treatment for gastroesophageal reflux disease (GERD) designed to restore the natural anatomy of the body without compressing the food passageway. The PMA application is supported by extensive long-term clinical data, including the company's pivotal clinical study with the 5-year follow-up requested by FDA, the results of which have been published in two peer-reviewed scientific papers demonstrating excellent long-term safety and efficacy outcomes for RefluxStop. RefluxStop is a treatment for GERD designed to address the root cause of acid reflux without compressing the food passageway. Unlike conventional anti-reflux surgical procedures, which typically rely on encircling the esophagus and are often associated with side effects such as swallowing difficulties, inability to belch or vomit, and gas bloating, RefluxStop restores and maintains the lower esophageal sphincter in its natural anatomical position. The unique mechanism of action of RefluxStop is designed to reconstruct the body's natural anti-reflux barrier while preserving normal physiological function, offering the potential for effective reflux control with reduced side effects compared to traditional surgical approaches. Announcement • May 20
Implantica Ag Announces Breakthrough Long-Term Refluxstop Data on Severe Sufferers Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the innovative RefluxStop device for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces breakthrough long-term data from Inselspital in Bern, the largest university hospital in Switzerland, demonstrating excellent safety and efficacy in complex patients, including aperistalsis and lung transplant recipients. The data presented included 82 RefluxStop patients followed for up to 7.25 years (September 2018 to February 2025), with 50% of patients reaching four years of follow-up. The long-term outcomes demonstrated excellent safety and clinical efficacy, with minimal side effects and results broadly consistent with previously reported excellent RefluxStop clinical data. Importantly, this study also included patients with severe and complex conditions, such as lung transplant patients and patients with aperistalsis in which the esophagus fails to contract, major unmet medical needs that have historically had limited or poor treatment options. According to the data presented, all 6% of the patients with aperistalsis and long-term follow-up experienced substantial improvement or complete symptom resolution following treatment with RefluxStop. This has larger implications, since patients with long-term acid reflux often develop a damaged esophagus, which may lead to reduced food transportation ability. Among the patients treated, an additional 57% had reduced food transportation indicating that the esophagus had been weakened by long-term acid exposure and severe disease. The study also included lung transplant recipients, estimated to be a few thousand per year in the U.S., representing a particularly vulnerable population because acid reflux can critically affect lung function and transplant outcomes. Dr. Borbély reported successful treatment of the first three lung transplant patients, including one prior to the RefluxStop procedure. These findings may have much broader implications for significantly larger patient populations suffering from pulmonary diseases where acid reflux can contribute to ongoing lung damage. In the U.S. alone, approximately 3 million people suffer from emphysema and approximately 14 million from chronic obstructive pulmonary disease (COPD) in the U.S., patient groups that may potentially benefit from improved reflux management. Implantica's lead product, RefluxStop, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. RefluxStop is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It's unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GORD involve encircling the food passageway to support the lower oesophageal sphincter's closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit. In contrast, the RefluxStop device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower oesophageal sphincter in its original, natural position. The RefluxStop mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux. Live News • May 20
Implantica Advances Toward FDA Decision After Completing Final RefluxStop Submission Implantica has submitted its final response to the FDA addressing all remaining questions on Module 3 of the Premarket Approval application for its RefluxStop device.
The filing includes completion of additional testing and review of all PMA modules, indicating that the company has finished the required technical and regulatory work for this stage.
Implantica reports that six pre-approval inspections tied to the PMA process have been successfully concluded, which the company describes as a major milestone toward potential FDA approval and U.S. market entry for RefluxStop.
This milestone moves the RefluxStop PMA process into a more advanced regulatory phase, where the key remaining variable is how the FDA responds to the completed submission.
Investors may want to pay close attention to future FDA communications or timelines, as regulatory feedback could influence expectations around commercialization plans and related funding or partnership needs. Announcement • May 19
Implantica AG to Report Q1, 2026 Results on May 22, 2026 Implantica AG announced that they will report Q1, 2026 results at 8:00 AM, Central European Standard Time on May 22, 2026 Announcement • Apr 22
Implantica Ag Announces Landmark Refluxstop Study of 602 Patients Across 22 European Centers with Up to 6.75-Year Follow-Up Published in Nature's Scientific Reports Implantica AG announced the publication of the largest and first-of-its-kind real-world safety outcomes study of RefluxStop. The study, 'Safety outcomes in 602 GERD patients treated by RefluxStop: a multi-center real-world study from 22 centers across six European countries,' represents the most comprehensive assessment of RefluxStop's long-term safety to date. Key findings from the real-world study revalidate and reconfirm the excellent, best-in-class safety profile of the RefluxStop procedure: >98% of patients had no serious safety issues requiring reoperation; all events were resolved satisfactorily in all patients; the primary reason for reoperation (1.33%, accounting for two-thirds of re-operations) was recurrence of the repaired hiatal hernia - a part of the procedure common to all anti-reflux surgeries; in standard of care surgical procedures, recurrence rates of hiatal hernia are approximately tenfold higher than observed in this RefluxStop study; all other serious events occurred only in 1 out of 602 patients and were mainly associated with the learning curve of a new surgical procedure. The RefluxStop mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux. Buy Or Sell Opportunity • Feb 26
Now 22% undervalued after recent price drop Over the last 90 days, the stock has fallen 14% to kr46.00. The fair value is estimated to be kr58.84, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 27% over the last 3 years. Earnings per share has declined by 30%. For the next 3 years, revenue is forecast to grow by 61% per annum. Earnings are forecast to decline by 4.3% per annum over the same time period. Reported Earnings • Feb 26
Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2025 results: €0.28 loss per share. Net loss: €19.6m (loss narrowed 16% from FY 2024). Revenue exceeded analyst estimates by 1.4%. Earnings per share (EPS) missed analyst estimates by 8.3%. Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Medical Equipment industry in Sweden. Announcement • Feb 18
Implantica AG to Report Q4, 2025 Results on Feb 25, 2026 Implantica AG announced that they will report Q4, 2025 results at 8:00 AM, Central European Standard Time on Feb 25, 2026 Buy Or Sell Opportunity • Feb 06
Now 22% undervalued after recent price drop Over the last 90 days, the stock has fallen 16% to kr46.20. The fair value is estimated to be kr59.56, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 33% over the last 3 years, while earnings per share has been flat. Revenue is forecast to grow by 301% in 2 years. Earnings are forecast to decline by 34% in the next 2 years. Buy Or Sell Opportunity • Jan 19
Now 20% undervalued after recent price drop Over the last 90 days, the stock has fallen 17% to kr48.00. The fair value is estimated to be kr60.24, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 33% over the last 3 years, while earnings per share has been flat. Revenue is forecast to grow by 301% in 2 years. Earnings are forecast to decline by 34% in the next 2 years. Announcement • Nov 26
Implantica AG (publ) Announces its Innovative Device, RefluxStop® Implantica AG (publ) announced that its innovative device, RefluxStop®, was a central highlight of the recent Japan Foregut Conference. The exclusive event, organized by Dr. Yasuhiro Fujiwara of the Department of Gastroenterology at Osaka Municipal University, brought together approximately 120 top surgeons and GI experts focusing on cutting-edge foregut disease treatments. The conference provided a key platform for the presentation of compelling long-term clinical evidence for the RefluxStop® procedure. Key Data Presentations: Leading data was presented on the excellent 5-year outcomes of the RefluxStop® device, highlighting its long-term effectiveness in treating gastroesophageal reflux disease (GERD). Published data from the landmark study shows 97.9% of patients were free from daily PPI medication use at 5 years. Safety data from a 602 combined patient cohort was shared by Dr. Moustafa Elshafei, a distinguished expert in the field. This extensive data further reinforced the device's favorable safety profile, which is designed to avoid common side effects like difficulty swallowing or gas-bloating associated with traditional anti-reflux surgery. While GERD prevalence and preferences for treatment in Japan have historically differ from Western populations, the prevalence of GERD in Japan has been steadily increasing since the 1990's1. Today, GERD impacts an estimated 17.9% of Japanese adults2. There is thus a clear, increasing interest in innovative, side-effect-free solutions like RefluxStop®. The high interest in the clinical results from these 120 surgeons underscores the global need for effective, long-term GERD solutions in Japan. Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, Reflux stop®, is a CE-marked implant for the prevention of gastroesophageal refux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based primarily on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Major Estimate Revision • Nov 07
Consensus EPS estimates upgraded to €0.26 loss, revenue downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from €2.12m to €2.04m. 2025 losses expected to reduce from -€0.294 to -€0.259 per share. Medical Equipment industry in Sweden expected to see average net income growth of 52% next year. Consensus price target of kr73.08 unchanged from last update. Share price rose 6.8% to kr55.00 over the past week. Reported Earnings • Nov 02
Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2025 results: €0.06 loss per share. Net loss: €4.34m (loss narrowed 31% from 3Q 2024). Revenue missed analyst estimates by 12%. Earnings per share (EPS) exceeded analyst estimates by 23%. Revenue is forecast to grow 71% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Medical Equipment industry in Sweden. Major Estimate Revision • Oct 16
Consensus revenue estimates decrease by 64%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from €5.85m to €2.10m. EPS estimate increased from -€0.401 to -€0.29 per share. Medical Equipment industry in Sweden expected to see average net income growth of 40% next year. Consensus price target of kr73.08 unchanged from last update. Share price fell 12% to kr57.80 over the past week. Breakeven Date Change • Oct 15
No longer forecast to breakeven The analyst covering Implantica no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of €14.0m in 2027. New forecast suggests the company will make a loss of €14.1m in 2027. Announcement • Oct 13
Implantica Completes FDA 100-Day Meeting for RefluxStop PMA Application Implantica AG (publ.) announced the successful completion of its 100-Day meeting with the U.S. Food and Drug Administration (FDA) regarding the Premarket Approval (PMA) application for RefluxStop®?. The 100-Day meeting represents a key milestone in the FDA's PMA review process, providing an opportunity for the company and the FDA review team to discuss preliminary findings of the submission, clarify outstanding questions, and confirm the pathway forward. Announcement • Sep 27
Implantica Ag Steps Up to Close the Treatment Gap with Refluxstop®? as Main Device Competitor Enters Europe and the Uk Implantica AG (publ.) announced its commitment to expand the availability of RefluxStop and training of new centers across Europe and the UK in view of the recent announcement to withdraw the LINX™? Reflux Management Systemfrom the European market effective March 31, 2026, as reported across many media outlets. Announcement • Sep 24
ImImplantica AG (publ.) Announces U.S. FDA Provides Feedback on the Final RefluxStop®? PMA Submission, Module 3 Implantica AG (publ.) announced that the U.S. Food and Drug Administration (FDA) has supplied its review of the final PMA Module 3 submission for RefluxStop and provided favorable feedback, as assessed by the company. Announcement • Sep 17
Implantica Ag's Refluxstop®? Spines Strong Exciting Strong Exciting At the American Foregut Society Meeting, Ahead of Pending US FDA Approval Implantica AG (publ.) announced RefluxStop®? was met with great enthusiasm and positive feedback among 600+ attendees at the 2025 American Foregut Society (AFS) Annual Meeting, further accelerating US pre-launch readiness. Anticipation for RefluxStop®? in the US reached a fever pitch last week as the nation's top foregut surgeons and gastroenterologists gathered in Dallas for the AFS Annual Meeting. Even though the US launch is yet to come, RefluxStop®? was the topic of much sought-after independent presentations by the most esteemed surgeons. In addition, the dynamic RefluxStop®? educational panel discussion attracted nearly 120 top surgeons and GI experts, well above the planned capacity, packing the room with great excitement to learn more about RefluxStop®?. Dr. John Lipham, USC Chief of the Division of Upper GI and General Surgery and Associate Professor of Surgery at the Keck School of Medicine and Past President of AFS moderated the well-attended RefluxStop®? panel discussion where the excitement was palpable. The panel featured a lively discussion of the long-term data outcomes and the unique mechanism of action of the RefluxStop®? procedure for treatment of acid reflux/GERD with an implant that does not encircle the esophagus. Reported Earnings • Aug 14
Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2025 results: €0.08 loss per share. Net loss: €5.43m (loss narrowed 15% from 2Q 2024). Revenue missed analyst estimates by 57%. Earnings per share (EPS) exceeded analyst estimates by 31%. Revenue is forecast to grow 105% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Medical Equipment industry in Sweden. Announcement • Aug 13
Implantica Completes New Multi-Cavity Production Tool for RefluxStop to Support Manufacturing Ramp-Up in the U.S. Pending FDA Approval Implantica AG (publ.) announced completion and initial validation of a new RefluxStop®? U.S. production tool as Implantica prepares for quickly increasing demand from the U.S. and markets worldwide, pending FDA approval. To ensure patients and surgeons across the globe will be able to access RefluxStop®? quickly in the future, Implantica has developed and successfully completed initial testing on two new multi-cavity production tools for manufacturing of larger quantities of the RefluxStop®? device. One tool will help support manufacturing ramp-up in Europe and one tool will be used to setup a new manufacturing site in the U.S. Announcement • Aug 08
Implantica Announces Second Publication of Groundbreaking 5-Year Results from the Landmark Refluxstop Clinical Study Implantica AG (publ) announced the second peer-reviewed publication of the remarkable 5-year outcomes from its CE mark clinical study of RefluxStop®?, a revolutionary device for the treatment of acid reflux-a condition affecting over 1 billion people worldwide. The newly released publication focuses on long-term safety and effectiveness outcomes and complements the earlier 5-year report on food passageway-related outcomes. Both studies were published in the prestigious journal Surgical Endoscopy, jointly produced by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES). The second publication, titled "Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: A prospective multicenter trial of safety and effectiveness," provides the ultimate validation of RefluxStop®?'s consistent and outstanding clinical performance. Key highlights include: 97.9% of patients were free from proton pump inhibitor (PPI) medication use at 5 years, compared to 100% of patients taking PPIs pre-RefluxStop®? surgery. No device-related adverse events reported over the entire 5-year study period. Quality of life (GERD-HRQL scores) improved by a median of 90% (IQR), p. Implantica is a MedTech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop®?, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Announcement • Jul 02
Implantica AG Announces Publication of the RefluxStop®? 5-Year Clinical Study Results Demonstratingexcellent Long-Term Success Implantica AG (publ.) announced the publication of RefluxStop's extraordinary 5-year clinical data for food passageway-related outcomes in the prestigious journal, Surgical Endoscopy, an official journal of SAGES (American Gastrointestinal and Endoscopic Surgeons) and EAES (European Association For Endoscopic Surgery). The 5-year study results, where the first published article is about food passageway sequelae, show remarkable outcomes in relation to standard of care, supporting a paradigm shift in treatment of acid reflux sufferers. The 5 year and end of study results show: 97.9% of patients without any Adverse Event Dysphagia (diff difficulty swallowing); 97.9% of patients with gas-bloating eliminated, improved or equivalent; 100% of the study patients maintained the ability to belch or vomiting. Nissen fundoplication at 5 years presented with: Dysphagia in 28.9%, gas bloating in 52.7%, and inability to belch and vomiting in 39.8%. The difference in outcomes are of such magnitude that they support an edict to a paradigm shift in acid reflux treatment. Publication of this study marks the dawn of a new era in the surgical treatment of GERD, one in which patients will have an innovative surgical treatment available that can restore the natural function of their body with minimal food passageway-related sequelae. Announcement • Jun 24
Implantica AG Submits the Last and Final Module 3 of the FDA PMA Application for RefluxStop® for US Market Approval Implantica AG (publ.) announced the submission of the third and final module of the RefluxStop® pre-market approval (PMA) application with the US Food and Drug Administration (FDA), along with responses to the second module. Implantica submitted the last and final Module 3 of the RefluxStop® PMA application together with the response to Module 2 review findings to FDA yesterday. Module 2, the clinical module, primarily addressed what we believed were minor findings. Module 3 is focused on tests of the product such as bench testing and biocompatibility testing for the RefluxStop® device. In line with the positive feedback in the FDA PMA application process so far, the latest RefluxStop® data submitted as part of the Module 2 response, as well as in the final Module 3, is quite robust and conclusive in Implantica's opinion. We hope the newly submitted data and responses will not only continue to meet the stringent requirements for the PMA approval process but also exceed them. The continued process relies to a large extent now on FDA, which will guide Implantica in the coming steps. FDA's feedback on Module 3 is expected sometime in the autumn. Announcement • Jun 12
Implantica AG Announces New Real-World Swiss Study on 99 Refluxstop™ Patients Comparing Small and Large Hiatal Hernia, Confirming Equally Excellent Long-Term Results Implantica AG (publ.) announced the publication of a new independent real-world study from Switzerland demonstrating RefluxStop™'s consistent long-term outcomes irrespective of large or small hiatal hernia size before surgery, proving it to be a favorable option for patients also with large hernia. The study entitled, "A safety and effectiveness evaluation of RefluxStop in the treatment of acid reflux comparing large and small hiatal hernia groups: Results from 99 patients in Switzerland with up to 4-year follow-up," was jointly conducted by Dr. med. Yves Borbély of Inselspital University Hospital in Bern, Switzerland, and Dr. med. Joerg Zehetner of Hirslanden Clinic Beau-Site, Bern, Switzerland. This is the first independent study in large hernia patients treated with RefluxStop™ procedure that was published in the acclaimed journal The World Journal of Hernia and Abdominal Wall Surgery.Patients with large hernia, where the stomach protrudes through the opening of the diaphragm, have so far been difficult to treat with existing methods. The key finding from this paper shows RefluxStop™ is safe and effective in both large and small hernia size patient groups, with no significant difference in adverse events. Furthermore, all patients reported a significant improvement in their GERD-HRQL scores after the RefluxStop™ procedure, including those with large hiatal hernia (4-10 cm).Large hiatal hernia is very common and a well-known predictor of treatment failure after traditional anti-reflux surgery and RefluxStop™ seems to serve this difficult-to-treat population very well with its unique mechanism in which the implant acts as a mechanical stop against upward movement of abdominal structures and hernia recurrence. Announcement • Jun 05
Implantica AG Announces UK NICE Has Published Positive Interventional Procedures Guidance (IPG) Recommendations on the RefluxStop™ Procedure Implantica AG (publ.) announced that the world-renowned National Institute for Healthcare Excellence (NICE) payer advisory agency for NHS public hospitals in the UK has published positive Interventional Procedures Guidance (IPG) recommendations on the RefluxStop™ procedure, wherein GORD/GERD patients with Ineffective Oesophageal Motility (IOM/IEM) are allowed to be operated with RefluxStop procedure in the public healthcare system, following its guidelines and special arrangements. In the treatment field of acid reflux up to 40%-50% of the 1 billion sufferers have IOM/IEM. Therefore, NICE IPG recommendations could transform the lives of millions of patients in the UK and worldwide, given NICE's global influence on health policy development. The IOM/IEM condition is largely untreatable with traditional standard of care. Announcement • May 27
Implantica AG (publ.) Reports Successful Pre-Launch Activities in the U.S Implantica AG (publ.) reported successful pre-launch activities in the U.S., pending FDA approval, with European real-world clinical evidence generating much interest from U.S. surgeons. Several presentations on RefluxStop were held at DDW, an impressive hub for discussing the latest innovations and clinical data in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Over 13,000 leading surgeons, gastroenterologists (GIs), academics, and researchers recently gathered in San Diego, California for the 2025 conference. Performing resurgery using RefluxStop on failed standard of care procedures was a topic of a study on the combined results from. The conclusion was that RefluxStop provides successful outcomes when used for reoperations on the most common standard surgical methods. RefluxStop was favorably discussed during the "Technologies and Procedural Innovation" session presentation by Dr. Reginald Bell, the leading US surgeon and past President of the American Foregut Society (AFS). All sessions boasted high attendance driven by high interest in the unique approach and the impressive European clinical data outcomes of the RefluxStop procedure. The RefluxStop procedure's unique mechanism of action eliminates many of the uncomfortable post-surgical side effects typically associated with anti-reflux procedures. The RefluxStop procedure's unique mechanism of actions eliminates many of the uncomfortable post the uncomfortable post-surgicalside effects typically associated with anti- Reflux procedures. The Reflux stop procedure's unique mechanism the company's unique mechanism of action eliminates Many of the uncomfortable post-s surgical side effects typically associated withanti-reflux procedures. The company strongly believe RefluxStop is uniquely positioned to have a lasting impact on the anti-reflux surgery landscape for decades to come. New Risk • May 17
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€13m net loss in 2 years). Share price has been volatile over the past 3 months (10% average weekly change). Revenue is less than US$5m (€2.1m revenue, or US$2.3m). Announcement • May 16
Implantica AG Appoints Tomas Puusepp as Member of the Nomination and Remuneration Committee Implantica AG at its AGM held on May 15, 2025, approved to elect Tomas Puusepp as member of the nomination and remuneration committee until completion of the next AGM. New Risk • May 09
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: €23m Forecast net loss in 2 years: €13m 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. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€13m net loss in 2 years). Revenue is less than US$5m (€2.1m revenue, or US$2.3m). Announcement • May 02
Implantica AG to Report Q1, 2025 Results on May 09, 2025 Implantica AG announced that they will report Q1, 2025 results at 8:00 AM, Central European Standard Time on May 09, 2025 Announcement • Apr 26
Implantica AG, Annual General Meeting, May 15, 2025 Implantica AG, Annual General Meeting, May 15, 2025, at 14:00 W. Europe Standard Time. Location: at hotel kommod, industriering 14, 9491 ruggell, liechtenstein Sweden Reported Earnings • Apr 17
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: €0.082 loss per share (improved from €0.084 loss in FY 2023). Net loss: €23.3m (loss narrowed 1.7% from FY 2023). Revenue missed analyst estimates by 5.3%. Earnings per share (EPS) exceeded analyst estimates by 8.5%. Revenue is forecast to grow 87% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 10% per year whereas the company’s share price has fallen by 13% per year. Announcement • Mar 19
Implantica Announces Further Expansion of Refluxstop Centers of Excellence and Patient Access in Spain Implantica AG (publ.) announced that the RefluxStop™? procedure is now being performed at the Hospital Vithas 9 de Octubre, in Valencia, Spain. Breakeven Date Change • Feb 15
Forecast to breakeven in 2027 The analyst covering Implantica expects the company to break even for the first time. New forecast suggests the company will make a profit of €14.1m in 2027. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Reported Earnings • Feb 15
Full year 2024 earnings released: €0.34 loss per share (vs €0.084 loss in FY 2023) Full year 2024 results: €0.34 loss per share. Net loss: €23.3m (loss narrowed 1.7% from FY 2023). Revenue is forecast to grow 87% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Medical Equipment industry in Sweden. Announcement • Feb 15
Implantica Announces Positive Feedback Received from U.S. FDA of the Refluxstop PMA Module 2 Submission Implantica AG (publ.)announced that U.S. FDA has completed its review of the PMA Module 2 submission and provided its feedback, in which the company sees no barrier for responding. FDA has completed its review of the company's second modular submission of its PMA, which contained the Clinical Data, Usability Testing, and Labeling information supporting RefluxStop™.FDA has provided Implantica with its written feedback on the content submitted, all of which the company considers to be minor. A response strategy has been identified for the questions raised, and the company sees no impediment to the overall PMA approval process based on FDA's Module 2 feedback. Responses to the Module 2 feedback will be submitted in conjunction with the final Module 3 submission in the near term. Announcement • Feb 12
Implantica Announces Module 1 Accepted and Closed by FDA in the PMA Application for RefluxStop Implantica AG (publ.) announced that the FDA has accepted Module 1 of the company's premarket approval (PMA) application, and that this module is now considered closed. Module 1 contained the quality systems and manufacturing information for RefluxStop, including the production and packaging information. FDA's review has been completed in full and the quality systems/manufacturing module is now considered closed by FDA. Prior to formal PMA approval of RefluxStop, FDA will perform a pre-approval inspection of the production sites to ensure the RefluxStop manufacturing facilities, methods, and controls are in compliance with the applicable requirements of the Quality System regulation (21 CFR part 820). Breakeven Date Change • Jan 01
Forecast to breakeven in 2027 The analyst covering Implantica expects the company to break even for the first time. New forecast suggests the company will make a profit of €14.1m in 2027. Average annual earnings growth of 43% is required to achieve expected profit on schedule. Announcement • Dec 17
Implantica Deepens Market Penetration in Italy with the Addition of the Ninth Refluxstop Center of Excellence Implantica AG (publ.) announced the first RefluxStop procedures were completed this month by Dr Günther Sitzmann, head of General Surgery Department at Ospedale di Brunico, part of Azienda Sanitaria dell'Alto Adige, Brunico, Italy. Dr. Sitzmann at Ospedale di Brunico performed the procedure on two patients, and both have recovered well. He was supported by Prof. Dr. med. Moustafa Elshafei of Nordwest Hospital Frankfurt, Germany. Based on this success, two more cases are already planned for January 2025. The demand for RefluxStop continues with Ospedale di Brunico the ninth leading anti-reflux hospital in Italy to offer the RefluxStop procedure. Several new centers are lined up to get started in the coming months. RefluxStop has been performed in over 1000 patients across Europe, as top foregut surgeons turn to this innovative technology to help their chronic GERD patients. The RefluxStop procedure addresses the root cause of GERD by restoring the natural anatomy and physiology of the body. The unique mechanism of action of RefluxStop allows the surgeon to restore the anti-reflux barrier without encircling the food passageway, thus making a surgical solution for GERD available to countless patients who may not have been candidates for traditional surgical GERD procedures. Major Estimate Revision • Nov 22
Consensus revenue estimates decrease by 33%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from €3.00m to €2.00m. EPS estimate increased from -€0.386 to -€0.37 per share. Medical Equipment industry in Sweden expected to see average net income growth of 43% next year. Consensus price target down from kr56.88 to kr53.87. Share price fell 13% to kr37.35 over the past week. Reported Earnings • Nov 17
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2024 results: €0.09 loss per share (further deteriorated from €0.019 loss in 3Q 2023). Net loss: €6.33m (loss widened 16% from 3Q 2023). Revenue missed analyst estimates by 59%. Earnings per share (EPS) exceeded analyst estimates by 16%. Revenue is forecast to grow 110% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 14% per year whereas the company’s share price has fallen by 15% per year. Announcement • Nov 15
Implantica AG to Report Q4, 2024 Results on Feb 14, 2025 Implantica AG announced that they will report Q4, 2024 results on Feb 14, 2025 Announcement • Nov 14
Implantica AG (publ.) Submits FDA PMA Application Clinical Module 2 for RefluxStop for U.S. Market Approval Implantica AG (publ.) announced the submission of the second clinical module of the Premarket Approval (PMA) application to the US FDA for RefluxStop along with responses to the FDA's findings from the first module. The second module submitted earlier this week for the RefluxStop PMA is the most crucial module of the three-module process for FDA approval. The outcome of the company's clinical study submitted to FDA shows fantastic positive results, which has echoed around the surgical community, fueling a vibrating interest in RefluxStop among surgeons and GIs all around the world and especially in the U.S. Together with Module 2, responses to the FDA's findings from Module 1 were also submitted, which the company believes are minor findings. In addition, the finalization of Module 3 is ongoing. The US FDA has agreed to a modular submission process for the RefluxStop PMA application, which allows for ongoing review and feedback from the FDA as each module is submitted. Announcement • Nov 08
Implantica AG to Report Q3, 2024 Results on Nov 15, 2024 Implantica AG announced that they will report Q3, 2024 results at 8:00 AM, Central European Standard Time on Nov 15, 2024 Announcement • Oct 10
Implantica Ag (Publ.) Announces Highly Successful 2024 American Foregut Society Meeting Where Refluxstop Received Remarkable Pre- Launch Market Feedback Implantica AG (publ.) reported an impressive level of support from a large number of U.S. doctors who are interested to start with RefluxStop®? after launch, pending FDA approval, driven by the very solid clinical results from the 5-year CE-study and real world outcomes from multiple centers that mirror these excellent results. Over 600 of the world's top anti-reflux surgeons, gastroenterologists, and other experts met to discuss treatment innovations in foregut diseases at the American Foregut Society (AFS) Annual Meeting in Colorado, where RefluxStop®? dominated the discussions. Implantica is actively working on the FDA approval process to bring RefluxStop®? to the US market with the PMA filing of the second module (of three) expected in the near-term. The RefluxStop®? procedure was at the forefront of the new innovation discussions at the AFS meeting. The meeting was revved up with a power-packed panel about RefluxStop including the leading US Surgeons and Gastroenterologists, moderated by Dr. John Lipham, Chief of the Division of Upper GI and General Surgery and Professor at the Keck School of Medicine of the University of Southern California and AFS Past President. Dr. Lipham opened the meeting by announcing the 5-year long-term outcomes data from the CE mark study that further reinforces the already published 1-year and 4-year results that are largely consistent with the published real-world data from Europe, including the latest safety and quality-of-life outcomes from over 200 patients in Switzerland and Germany, presented at the AFS meeting. Announcement • Sep 25
Implantica AG announces finalization of remarkable 5-year pivotal CE mark study results and gears up for the Module 2 submission of PMA application to FDA for RefluxStop Implantica AG (publ.) announced finalization of the 5-year CE mark study results as part of the upcoming Module 2 submission (of 3 modules) of the RefluxStop premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA). Implantica has prepared responses to FDA's feedback from Module 1 to be submitted together with Module 2 of the RefluxStop PMA application. Module 2 is planned to be submitted in the near-term (during autumn) as agreed with the FDA. The Implantica team has worked very hard to ensure that this study is thoroughly completed and analyzed as per the rigorous FDA requirements. Module 2 is the most important of the three modules included in the PMA filing and will contain the clinical and usability data, including the results of the CE-mark clinical investigation and the results from Human Factors Validation Study performed earlier this year with 16 US foregut/reflux surgeons in Chicago. A summary of the objective and exceptional 5-year clinical results from the CE mark study shows: Contrast swallow x-rays at year 5 show the devices in place and well functioning with no device dislocations, no device migration, and no re-herniation. 24-hour pH monitoring, measuring the acidity in the lower esophagus over 24-hours, also provides excellent results. Only one subject is dissatisfied and has a failed/pathologic 24-hour pH monitoring test. In comparison, main device competitor at their FDA trial reported 42% pH test failures at year 1. Announcement • Sep 18
Implantica AG Announces Excellent Data from an Independent Study of 158 RefluxStop Patients from Two Centers in Germany - Presented at the AUGIS Meeting in UK Implantica AG reported that the study Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis, shows over 90% improvement in GERD quality-of-life scores in patients 2 years after the procedure. The study was recently presented at the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS) 2024 Conference. AUGIS promotes high-quality training programs, such as this Scientific Meeting, for the surgical treatment of gastrointestinal disorders in the UK. This German study included 158 patients and reported impressive two-year follow-up effectiveness and safety outcomes with patients achieving significant improvement in their symptoms, and as a result, 96.4% of patients discontinued their regular PPI medication. An impressive 90.9% improvement in GERD-HRQL quality of life score was achieved although many of the patients had difficult-to-treat conditions, such as 22% had large hiatal hernia (over 3 cm), 44% active esophagitis and 10% precancerous changes (Barrett's esophagus). Data for the study came from top German anti-reflux surgeons; Dr. med. Moustafa Elshafei, study lead at Krankenhaus Nordwest, Frankfurt and Dr. med. Thorsten Lehmann, study lead at Klinikum Friedrichshafen, Friedrichshafen. Announcement • Sep 12
Implantica Announces Demise of Board Member Prof. Dr. Klaus Neftel Implantica AG (publ.) announced with regret that Prof. Dr. Klaus Neftel, a member of the Implantica Board of Directors, has passed away. Prof. Dr. Neftel was appointed as a director of the Implantica Group in January 2018. He was the former Chief of Internal Medicine at the Ziegler Hospital in Bern as well as a Professor at the University of Bern. He was also the Editor of the Swiss Medical Forum and previously developed and lead an internet portal for a nationwide CME (Continued Medical Education) program. Major Estimate Revision • Aug 28
Consensus revenue estimates decrease by 17%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from €3.60m to €3.00m. EPS estimate increased from -€0.631 to -€0.39 per share. Medical Equipment industry in Sweden expected to see average net income growth of 32% next year. Consensus price target up from kr42.94 to kr56.12. Share price was steady at kr47.00 over the past week. Reported Earnings • Aug 22
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: €0.09 loss per share (further deteriorated from €0.018 loss in 2Q 2023). Net loss: €6.38m (loss widened 23% from 2Q 2023). Revenue missed analyst estimates by 38%. Earnings per share (EPS) exceeded analyst estimates by 42%. Revenue is forecast to grow 101% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 19% per year whereas the company’s share price has fallen by 24% per year. Announcement • Aug 20
Implantica AG Announces Refluxstop Pivotal 4-Year Study Results Published in the Prestigious Journal Surgical Endoscopy Implantica AG (publ.) announced excellent long-term safety and clinical 4-year outcomes with the RefluxStop device (in the prospective multi-center CE study), which have recently been published in the prestigious journal, Surgical Endoscopy, an official journal of SAGES (American Gastrointestinal and Endoscopic Surgeons) and EAES (European Association For Endoscopic Surgery), entitled"Treating acid reflux without compressing the food passageway". Results from the study confirm that 4-year outcomes mirror the excellent 1- and 3-year outcomes reported previously. These results further validate and reinforce the consistency and long-term safety and efficacy of RefluxStop(TM) in treating gastroesophageal reflux disease (GERD). The study represents continued reporting on the cohort of 50 patients who were part of the CE Mark study. At 4-year follow-up, patients experienced 90% improvement in GERD Health-Related Quality of Life (GERD-HRQL questionnaire) score, with no patients requiring daily medical therapy for acid reflux. 46/47 patients had no swallowing problems (dysphagia) at follow-up compared to 11 cases of mixed severity of dysphagia before surgery, which is one of the most common complications with standard of care procedures usually reaching about 30% at 5-year follow-up. No patient was dissatisfied because of acid reflux, as verified by normal 24-hour pH monitoring in the lower esophagus. Furthermore, the complications have been very limited with no device-related adverse events, no device deficiencies, no device explants, no device migrations/erosion, or no esophageal dilatations during the entire study. Announcement • Jul 25
Implantica Announces Continuing Progress in Modular PMA Application to FDA for Refluxstop Implantica AG (publ.) announced that the Module 1 review of the company's FDA premarket approval application (PMA) submission is progressing as expected. Upon completion of its review of Module 1, the first of three modules to be submitted in PMA, FDA provided Implantica a list of deficiencies, all of which the company considers to be minor. No major issues have been identified by FDA thus far, and Implantica is in the process of addressing these comments. Based on FDA's response, the company has decided to submit Module 2 of the company's PMA application once response to FDA's findings on Module 1 has been finalized. Based on this approach, the company does not anticipate any significant impact on the overall timeline. Implantica will provide an update within the next 1-2 months. Announcement • Jul 11
Implantica Announces New Health-economics Data Publication Showing RefluxStop's Superior Cost-Effectiveness for the Swiss Healthcare System Implantica AG announced new health-economics data publication showing RefluxStop's superior cost-effectiveness for the Swiss healthcare system. The company reports the study, Analysis of Cost-Effectiveness in Switzerland for a New Implantable Device to Treat Chronic Gastroesophageal Reflux Disease, was published recently by the Journal of Medical Economics. The comprehensive health economic analysis published in this study found that RefluxStop™ is highly likely to be a cost-effective treatment for GERD in Switzerland against Nissen fundoplication, Magnetic Sphincter Augmentation (LINX System) and PPI-based medical management. Higher improvement of patient’s quality of life (Quality Adjusted Year Life (QALY)) scores and lower costs were achieved by RefluxStop™ compared to Nissen fundoplication and the LINX system. The data was published in The Journal of Medical Economics, which serves an international audience and publishes rigorously peer-reviewed economic assessments of novel therapeutic and device interventions. The study authors represent a partnership between the York Health Economics Consortium, UK and leading reflux centers of excellence in Switzerland, including Dr. med. Yves Borbély, Department of Visceral Surgery and Medicine, Inselspital Bern University Hospital, Switzerland, and Prof. Dr. med. Joerg Zehetner, Department of Visceral Surgery, Swiss1Chirurgie, Hirslanden Klinik Beau-Site Switzerland. Reported Earnings • May 17
First quarter 2024 earnings: EPS and revenues exceed analyst expectations First quarter 2024 results: €0.05 loss per share. Net loss: €3.36m (loss narrowed 26% from 1Q 2023). Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) also surpassed analyst estimates by 69%. Revenue is forecast to grow 90% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Medical Equipment industry in Sweden. Announcement • Mar 27
Implantica Submits U.S. FDA Premarket Approval (PMA) Application for RefluxStop® (first module) Implantica AG (publ.) announces the submission of the first module of the PMA application to the U.S. FDA for RefluxStop®, an innovative device for the treatment of Gastroesophageal Reflux Disease (GERD). The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application. This process provides for ongoing review and feedback from the FDA as the modules are submitted. The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year. An estimated 27% of the adult population in the U.S. struggle with GERD1 and 40% of GERD patients don't respond to PPIs, the most common medication to treat the disease.2 This leaves tens of millions of patients with limited options to treat the relentless, painful symptoms of GERD. Even worse, in the U.S. and EU, around 48,000 people die annually from esophageal adenocarcinoma, with strong indications in the literature to be caused by acid reflux. Announcement • Mar 26
Implantica Completes Human Factors Validation Study for RefluxStop as Part of the US FDA Premarket Approval Process Implantica AG (publ.) announced completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™. In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop™ procedure at Northwestern University's Simulation Lab in Chicago. RefluxStop™ is an innovative new surgical procedure for the treatment of gastroesophageal reflux disease (GERD). The goal of the study is to demonstrate how surgeons at varying levels of surgical experience from academic, community, and private clinics in the US, carry out the RefluxStop procedure. In the next step of the study, an independent third party is evaluating the data collected during testing in Chicago. Findings are included in Implantica's application for an FDA PMA for RefluxStop. The completion of this Human Factors study marks a critical milestone, which Implantica hopes will significantly help advance the US market approval process and ultimately result in the widespread availability of RefluxStop in the US. Reported Earnings • Feb 18
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: €0.34 loss per share (further deteriorated from €0.074 loss in FY 2022). Net loss: €23.7m (loss widened 14% from FY 2022). Revenue exceeded analyst estimates by 11%. Earnings per share (EPS) also surpassed analyst estimates by 7.3%. Revenue is forecast to grow 96% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 62% per year but the company’s share price has only fallen by 39% per year, which means it has not declined as severely as earnings. Announcement • Feb 06
Implantica Ag Announces the First RefluxStop Procedures Completed At MIC Hospital in Berlin Implantica AG (publ.) announced the first RefluxStop procedures completed at MIC Hospital in Berlin. Dr. Bjorn Siemssen, Head of the Reflux Center at MIC Kinik Berlin, has performed two successful RefluxStop procedures, a cutting edge treatment that addresses the root cause of GERD by restoring the body's natural physiology. Both patients returned to eating normally quickly after recovering from the laparoscopic procedure. New Risk • Jan 24
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€29m net loss in 3 years). Share price has been volatile over the past 3 months (9.5% average weekly change). Revenue is less than US$5m (€1.1m revenue, or US$1.2m). Recent Insider Transactions • Jan 22
Chief Corporate Affairs Officer recently bought kr1.2m worth of stock On the 17th of January, Nicole Pehrsson bought around 43k shares on-market at roughly kr28.60 per share. This transaction amounted to 8.9% 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 the only on-market transaction from insiders over the last 12 months. Major Estimate Revision • Dec 07
Consensus revenue estimates increase by 27% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from €1.00m to €1.27m. EPS estimate unchanged at -€0.367. Medical Equipment industry in Sweden expected to see average net income growth of 66% next year. Consensus price target of kr45.07 unchanged from last update. Share price rose 11% to kr19.92 over the past week. Major Estimate Revision • Nov 29
Consensus revenue estimates fall by 27% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from €1.37m to €1.00m. Forecast losses increased from -€0.341 to -€0.37 per share. Medical Equipment industry in Sweden expected to see average net income growth of 66% next year. Consensus price target down from kr55.79 to kr45.07. Share price was steady at kr17.98 over the past week. Reported Earnings • Nov 24
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: €0.08 loss per share. Net loss: €5.44m (loss narrowed 3.9% from 3Q 2022). Revenue missed analyst estimates by 28%. Earnings per share (EPS) exceeded analyst estimates by 4.5%. Revenue is forecast to grow 117% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Medical Equipment industry in Sweden. Announcement • Nov 21
Implantica AG (publ.)'s RefluxStop Offers for the First Time in the NHS in UK Implantica AG (publ.) announced that the first RefluxStop™ procedures have been successfully performed by the NHS at Imperial College Healthcare NHS Trust. Four patients with GORD underwent the RefluxStop(TM) procedure in early September at St Mary's hospital, part of Imperial College Healthcare NHS Trust. All had minimally invasive, keyhole surgery, were quickly discharged from hospital and have made an excellent recovery. All patients have been able to eat normally and have stopped taking medication to control their symptoms. Approximately 20% of the adult UK population have problems with severe acid reflux or GORD. For some, GORD is chronic and can cause severe pain, regurgitation, swallowing difficulties, cough, asthma, insomnia, voice loss, teeth and gum damage, nutritional problems and depression. Three of the four GORD patients treated with RefluxStop(TM) at St Mary's Hospital in Paddington, London, also had poor oesophageal motility, which means that their ability to push food down to the stomach is impaired and other surgical options were likely to be ineffective. Board Change • Sep 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. No highly experienced directors. Independent Board Member Tomas Puusepp was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Aug 18
Implantica AG to Report Q2, 2023 Results on Aug 24, 2023 Implantica AG announced that they will report Q2, 2023 results at 8:00 AM, Central European Standard Time on Aug 24, 2023 New Risk • Aug 13
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.2% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 4.0% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€33m net loss in 3 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Revenue is less than US$5m (€951k revenue, or US$1.0m). Major Estimate Revision • May 19
Consensus revenue estimates decrease by 21%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from €1.83m to €1.44m. EPS estimate increased from -€0.414 to -€0.356 per share. Medical Equipment industry in Sweden expected to see average net income growth of 63% next year. Consensus price target down from kr65.64 to kr57.96. Share price fell 6.5% to kr17.70 over the past week. Announcement • May 17
Implantica AG Announces RefluxStop Results Were Presented At the DDW Conference in Chicago Implantica AG (publ) announces that Dr. med. Zehetner, Prof. (USC) from Switzerland, presented Klinik Beau-Site’s RefluxStop results at Digestive Disease Week (DDW) 6-9 May, in Chicago, U.S., the world’s premier meeting for gastrointestinal professionals. Dr. med. Jörg Zehetner, Prof. (USC), surgeon at the Hirslanden Klinik Beau-Site Bern, Switzerland, highlighted the unique advantages of the RefluxStop™ therapy in the reflux patient population that have Ineffective Esophageal Motility (IEM), a disorder that often causes swallowing difficulties and pain, a patient group which does not have any optimal treatment options today. Encircling the food passageway as in existing treatments often worsen these patients’ swallowing difficulties and Dr. Zehetner sees RefluxStop™ as a potential major breakthrough for these patients. Despite the IEM condition in this group of 20 patients, all patients are showing complete resolution or significant improvement of reflux symptoms. Announcement • May 06
Implantica AG to Report Q1, 2023 Results on May 12, 2023 Implantica AG announced that they will report Q1, 2023 results at 8:00 AM, Central European Standard Time on May 12, 2023 Reported Earnings • Apr 21
Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2022 results: €0.074 loss per share (further deteriorated from €0.055 loss in FY 2021). Net loss: €20.8m (loss widened 36% from FY 2021). Revenue missed analyst estimates by 9.7%. Earnings per share (EPS) exceeded analyst estimates by 19%. Revenue is forecast to grow 98% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Medical Equipment industry in Sweden. Major Estimate Revision • Feb 27
Consensus revenue estimates decrease by 35%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from €3.03m to €1.96m. EPS estimate increased from -€0.535 to -€0.414 per share. Medical Equipment industry in Sweden expected to see average net income growth of 82% next year. Consensus price target down from kr81.64 to kr65.24. Share price fell 11% to kr33.50 over the past week. Reported Earnings • Feb 19
Full year 2022 earnings released: €0.30 loss per share (vs €0.055 loss in FY 2021) Full year 2022 results: €0.30 loss per share (further deteriorated from €0.055 loss in FY 2021). Net loss: €20.8m (loss widened 36% from FY 2021). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Medical Equipment industry in Sweden. Major Estimate Revision • Nov 22
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from €1.87m to €930.0k. EPS estimate increased from -€0.41 to -€0.37 per share. Medical Equipment industry in Sweden expected to see average net income growth of 24% next year. Consensus price target down from kr107 to kr80.42. Share price fell 12% to kr42.00 over the past week. Reported Earnings • Nov 19
Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2022 results: €0.08 loss per share (further deteriorated from €0.015 loss in 3Q 2021). Net loss: €5.66m (loss widened 33% from 3Q 2021). Revenue missed analyst estimates by 2.5%. Earnings per share (EPS) exceeded analyst estimates by 27%. Revenue is forecast to grow 140% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Medical Equipment industry in Sweden. Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 5 experienced directors. No highly experienced directors. Chief Strategy Officer & Board Member Stephan Siegenthaler is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Aug 23
Second quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2022 results: €0.08 loss per share (down from €0.042 loss in 2Q 2021). Net loss: €5.76m (loss widened 100% from 2Q 2021). Revenue missed analyst estimates by 17%. Earnings per share (EPS) exceeded analyst estimates by 12%. Over the next year, revenue is forecast to grow 1,177%, compared to a 103% growth forecast for the Medical Equipment industry in Sweden. Reported Earnings • May 12
First quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2022 results: €0.07 loss per share (down from €0.03 loss in 1Q 2021). Net loss: €4.78m (loss widened 143% from 1Q 2021). Revenue missed analyst estimates by 21%. Earnings per share (EPS) exceeded analyst estimates by 11%. Over the next year, revenue is forecast to grow 838%, compared to a 96% growth forecast for the industry in Sweden. Announcement • May 12
Implantica AG to Report Q4, 2022 Results on Feb 17, 2023 Implantica AG announced that they will report Q4, 2022 results on Feb 17, 2023 
