View Future GrowthAdvicenne 과거 순이익 실적과거 기준 점검 0/6Advicenne은 연평균 10.2%의 비율로 수입이 증가해 온 반면, Pharmaceuticals 산업은 연평균 8.8%의 비율로 증가했습니다. 매출은 연평균 14.3%의 비율로 증가했습니다.핵심 정보10.24%순이익 성장률22.72%주당순이익(EPS) 성장률Pharmaceuticals 산업 성장률7.33%매출 성장률14.26%자기자본이익률n/a순이익률-148.84%다음 순이익 업데이트17 Sep 2026최근 과거 실적 업데이트공시 • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026공시 • Nov 29Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025Reported Earnings • Apr 10Full year 2023 earnings released: €0.67 loss per share (vs €1.16 loss in FY 2022)Full year 2023 results: €0.67 loss per share (improved from €1.16 loss in FY 2022). Revenue: €3.48m (up 18% from FY 2022). Net loss: €7.03m (loss narrowed 39% from FY 2022). Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.공시 • Dec 29+ 2 more updatesAdvicenne S.A. to Report First Half, 2024 Results on Sep 18, 2024Advicenne S.A. announced that they will report first half, 2024 results on Sep 18, 2024공시 • Nov 30+ 2 more updatesAdvicenne S.A. to Report Fiscal Year 2022 Results on Mar 30, 2023Advicenne S.A. announced that they will report fiscal year 2022 results After-Market on Mar 30, 2023Reported Earnings • Oct 01First half 2021 earnings released: €0.93 loss per share (vs €0.92 loss in 1H 2020)The company reported a poor first half result with increased losses, weaker revenues and weaker control over costs. First half 2021 results: Revenue: €1.36m (down 16% from 1H 2020). Net loss: €7.99m (loss widened 3.8% from 1H 2020).모든 업데이트 보기Recent updates공시 • May 23Advicenne S.A. Announces Board ChangesAdvicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco).Board Change • May 20Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.공시 • Apr 16Advicenne S.A., Annual General Meeting, May 21, 2026Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris France공시 • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026공시 • Jan 19Advicenne S.A. Accepts for Review the New Drug Application for Sibnayal, A Fixed Combination of Potassium Citrate and Potassium Bicarbonate for the Treatment of Distal Renal Tubular AcidosisAdvicenne announced that the FDA (Food and Drug Administration) has accepted for review the New Drug Application (NDA) for Sibnayal®? (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal Renal Tubular Acidosis (dRTA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026. Following the submission of the New Drug Application (N DA) dossier on November 2, 2025, the U.S. FDA completed its standard 60-day filing review. During this period, Advicenne satisfactorily addressed several questions raised by the Agency. As agreed with the FDA, the 505(b)(2) application incorporates the European clinical studies that also underpin the recently renewed Marketing Authorization dossier in Europe.공시 • Jan 12Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European UnionAdvicenne obtains the renewal of its Marketing Authorization (MA) for Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the European Union. The European Medicines Agency (EMA) has renewed the marketing authorization for Sibnayal™ starting in January 2026. This renewal, which is mandatory five years after the initial issuance, definitively validates the marketing authorization. It marks a major milestone for the continued commercial development of Sibnayal®® in Europe. It is part of a busy regulatory program, with marketing authorization obtained in the Kingdom of Saudi Arabia in July 2025 and, more recently, the filing of a registration application with the US Food & Drug Administration.Board Change • Dec 30Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.공시 • Nov 05Advicenne Submitted to US FDA the Registration Application for Sibnayal® in dRTA TreatmentAdvicenne announced the submission of the registration application for Sibnayal® (fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) to the US Food and Drug Administration (US FDA). Sibnayal®® has been designated orphan drug in dRTA in the USA. The evaluation of the dossier should take approximately 12 months. The company will communicate on the main stages of the evaluation process as well as on the expected date of the US authorities' decision, which should be known within a few weeks.공시 • Jul 29Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal®? in Saudi ArabiaAdvicenne obtains marketing authorization (MA) and reimbursement status for Sibnayal®? (a fixed combination of potassium citrate and potassium bicarbonate) in the Kingdom of Saudi Arabia (KSA). Marketing authorization for Sibnayal™? (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. Furthermore, Saudi authorities have agreed a reimbursement rate in line with the best European pricing. This achievement results of a close collaboration between Advicenne and its local partner, Taiba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taiba Healthcare will manage local marketing activities. The incidence of dRTA is higher in Gulf countries than in Europe or the United States, and prevalence in KSA could be estimated around 600 to 800 patients. Sibnayal®®? is already prescribed through early access programs in several Gulf countries outside Saudi Arabia. This milestone paves the way for registrations in GCC countries where the application is filed.공시 • Apr 08Advicenne S.A., Annual General Meeting, May 15, 2025Advicenne S.A., Annual General Meeting, May 15, 2025. Location: 2 rue de la chaussee d antin, paris France공시 • Jan 29Advicenne Reaches A Significant Milestone with the Us FDA in the Development of Adv7103 in CystinuriaAdvicenne provided an update on recent exchanges with the U.S. FDA about the development of ADV7103 in cystinuria, and announces that it has reached an important milestone. As previously stated, the company has engaged in a new round of discussions with the US FDA to finalize the development plan for ADV7103 in cystinuria in the United States. During the latest meeting, Advicenne has presented a set of data, with the active presence of American opinion leaders, and the “International Cystinuria Foundation”, the main cystinuria patient group, specifically: The preliminary clinical results obtained in Europe in cystinuria patients, The European and American expert opinions on medical needs in this rare kidney disease, A proposed clinical development plan with a biological endpoint. Following this meeting, the FDA accepted Advicenne’s proposition of a biological primary endpoint for the evaluation of ADV7103 in cystinuria; a significant step in preparing for a clinical trial of limited duration and number of patients. Advicenne is now preparing the submission of the final draft of the pivotal trial in cystinuria to the FDA. The choice of the biological primary endpoint should enable the company to enroll patients both in the United States and Europe, and to consider filing simultaneously registration applications in both territories. ADV7103 has orphan drug status in the cystinuria indication in both Europe and the USA. Cystinuria affects around 30,000 patients in the US and 40,000 in Europe and represents a significant potential market for ADV7103.공시 • Nov 29Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025Board Change • Oct 03Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.공시 • Oct 01Advicenne Achieves Major Milestones in the US Due to Several Positive FDA Opinion on ADV7103Advicenne announced the achievement of major milestones in the development program of its ADV7103 drug in the U.S, and the search for commercial partners. ADV7103 in dRTA (Distal Renal Tubular Acidosis): European data deemed satisfactory by the FDA for filing without additional clinical studies in the US. After numerous exchanges with experts from the US Food & Drug Administration (FDA), the Agency has concluded that European clinical data can be used to support an application for registration in dTRA. As a result, Advicenne will not conduct a specific clinical study in the U.S., significantly reducing the time and cost required to file a marketing authorization application in the U.S. for this indication. The FDA's positive opinion was based on consideration of all the clinical data available from the European clinical program. Specifically, the pivotal phase III study (B21CS) and the long-term safety extension study (B22CS), which provide Advicenne with clinical data on efficacy and safety for patients followed over a period of more than 6 years. These studies, presented to the European Renal Association(ERA) and the European Society of Pediatric Nephrology (ESPN), are supplemented by data from real-life cohorts (Real World Evidence - RWE), and extensive European pharmacovigilance data. Following an initial phase of discussions, the FDA considered that the drug's safety data met its requirements in terms of long-term tolerability. This first phase opened the path to a discussion on the relevance of efficacy data from these same studies. This was the purpose of the second phase of exchanges with complementary analysis data from the studies. ADV7103 has orphan drug status in the dRTA indication in the US. The results of the above studies will be reported at an analysts' meeting to be scheduled shortly. ADV7103 in cystinuria: preparation for clinical development in consultation with the FDA. ADV7103 has been granted orphan drug designation (ODD) for the treatment of cystinuria in March 2024, adding to the existing orphan drug status for this indication in Europe. This validated Advicenne's regulatory and clinical strategy with the FDA. The ODD application was supported by preliminary clinical results in European patients with cystinuria and extensive data on the population size and expert opinion on the unmet need in this indication. Following this success, the Company wishes to discuss the proposed clinical development plan that will serve as the basis for a marketing authorization in this indication. A round of discussions will be launched before the end of the year. This clinical program proposed has strong support from experts in this condition from both Europe and the United States, as well as from the International Cystinuria Foundation, representing the patient population. There is broad agreement that alkalinization is a cornerstone of treatment and that there is no satisfactory alkalinizing treatment that provides well tolerated, 24-hour pH control, indicated by recent data from the European Cystinuria Registry showing only on fourth of cystinuria patients followed in Europe have a urinary pH above 7.5, the therapeutic target set by international recommendations. Pending the conclusion of discussions with the FDA and agreement on the clinical program, Advicenne plans to initiate a clinical trial in cystinuria. This study would recruit patients simultaneously in the United States and Europe and enable a registration application to be filed in both markets. In Europe, ADV7103 also has orphan drug status in this indication. The recent news flow is expected to generate further interest, which the Company intends to pursue actively, particularly from the end of 2024.Reported Earnings • Apr 10Full year 2023 earnings released: €0.67 loss per share (vs €1.16 loss in FY 2022)Full year 2023 results: €0.67 loss per share (improved from €1.16 loss in FY 2022). Revenue: €3.48m (up 18% from FY 2022). Net loss: €7.03m (loss narrowed 39% from FY 2022). Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.New Risk • Mar 29New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-€14m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (24% increase in shares outstanding). Revenue is less than US$5m (€2.7m revenue, or US$3.0m). Market cap is less than US$100m (€25.6m market cap, or US$27.7m).Board Change • Mar 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Board Change • Jan 24Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.공시 • Dec 29+ 2 more updatesAdvicenne S.A. to Report First Half, 2024 Results on Sep 18, 2024Advicenne S.A. announced that they will report first half, 2024 results on Sep 18, 2024공시 • Nov 30+ 2 more updatesAdvicenne S.A. to Report Fiscal Year 2022 Results on Mar 30, 2023Advicenne S.A. announced that they will report fiscal year 2022 results After-Market on Mar 30, 2023공시 • Jun 30Advicenne Announces Commercial Launch of Sibnayal in Great BritainAdvicenne S.A. announced that Sibnayal, combination of potassium citrate and potassium bicarbonate, has been made available to patients suffering from distal Renal Tubular Acidosis (dRTA) in Great Britain. Sibnayal has been approved in Great Britain since July 2021. Sibnayal has been added on the Department of Health list of drugs and is immediately available for doctors and patients in its indication. Advicenne has obtained, from the National Health Service (NHS) the selling price of Sibnayal® in Great-Britain and is now actively working to provide the National Institute for Health and Care Excellence (NICE) with additional information allowing positive opinion on the prescription’s guidance of Sibnayal. The next session with NICE is planned on August 4.공시 • Jun 10Advicenne S.A. Announces Executive ChangesAdvicenne S.A. announced that Mr. André Ulmann as a non-voting director, for a three-year term. The Board of Directors meeting held after this Meeting appointed as Chairman of the Board of Directors Mr. Philippe Boucheron, who will continue to serve as Chairman of the Remuneration Committee. The Board also noted the change in the permanent representative of Bpifrance Investissement, in the person of Mr. Thibaut Roulon who will also be member of the Audit Committee chaired by Mrs. Catherine Dunand. The Board of Directors of Advicenne is now composed of the following members: Philippe Boucheron, Director, Chairman of the Board; Mr. Didier Laurens, director, Chief Executive Officer; Cemag Invest, represented by Catherine Dunand, Director; Bpifrance Investissement, represented by Mr. Thibaut Roulon, Director; Irdi Soridec Gestion, represented by Mr. Jean-Michel Petit, director; Mrs. Charlotte Sibley, independent director; Mrs. Hege Hellstrom, independent director; Mr. André Ulmann, observer. The Combined General Meeting was an opportunity to present the progress of the Company's various programs and strategy.공시 • Apr 22Advicenne Appoints Philippe Boucheron as Chairman of Its Board of DirectorsAdvicenne announced the appointment of Philippe BOUCHERON as Chairman of the Board of Directors following the next Annual General Meeting to be held on June 9, 2022. This appointment follows David Horn SOLOMON’s decision not to seek the renewal of his term as director, entailing therefore the termination of his duties as Chairman of the Board of Directors from that same date.공시 • Mar 31Advicenne Announces the Release of Results of a Study Showing Improved Quality of Life in Patients Living With DRTa and Treated by ADV7103Advicenne announced the publication, in the peer-reviewed journal Orphanet Journal of Rare Disease, results of a study showing improvement in the long-term quality of life in patients with distal Renal Tubular Acidosis (dRTA) and treated with ADV7103. The patients' quality of life was assessed through interviews and conducted as part of the clinical development of ADV7103 after more than 5 years of treatment on average (62 +/- 6 months). The level of treatment satisfaction was 9 on a scale of 10 and the treatment met or exceeded expectations in 74% of patients (14 patients out of 17). These results confirm the interest of ADV7103 in the treatment of dRTA and the advantage of a bi-daily dosing compared to the usual management of this disease.공시 • Jan 25Advicenne Ordinary Shareholders' Meeting Approves Delisting from Regulated Market of Euronext BrusselsThe ordinary shareholders' meeting of Advicenne S.A. held on January 24, 2022, approved the proposed transfer of the listing of the Company's shares from the regulated market of Euronext Paris (Compartment C) to the multilateral trading facility of Euronext Growth Paris ('Euronext Growth Paris'), the proposed delisting of its shares from the regulated market of Euronext Brussels, and empowered the board of directors to carry out these transfer and concomitant delisting.Breakeven Date Change • Jan 14Forecast to breakeven in 2023The analyst covering Advicenne expects the company to break even for the first time. New forecast suggests losses will reduce by 61% per year to 2022. The company is expected to make a profit of €7.21m in 2023. Average annual earnings growth of 103% is required to achieve expected profit on schedule.공시 • Dec 20Advicenne Announces Positive Opinion from the French Transparency Commission (HAS) for Its Drug Sibnayal™ in dRTAAdvicenne announced is has received a positive opinion from the French Transparency Commission (HAS) with its lead asset, Sibnayal™ eligible for reimbursement with a Moderate Level SMR (Medical Rendered Service) and a Level IV ASMR (Medical Rendered Service Improvement), in the treatment of distal Renal Tubular Acidosis (dRTA) in adults, adolescents and children over the age of 1. This decision makes Sibnayal™ the only specialty pharmaceutical product reimbursed in the treatment of dRTA in France, which will significantly ease access to treatment of the disease for both patients and their doctors. The French Transparency Commission (HAS " Haute Autorité de Santé), in its opinion, acknowledges thecontribution of the twice-daily dosing formulation of Sibnayal™ which significantly improves the quality of life of patients as well as compliance to long-term treatment plans. These factors contribute to the continuous improvement of disease indicators, particularly bone mineral density, as shown by the clinical development of Sibnayal™ over a period of at least 4 years.Reported Earnings • Oct 01First half 2021 earnings released: €0.93 loss per share (vs €0.92 loss in 1H 2020)The company reported a poor first half result with increased losses, weaker revenues and weaker control over costs. First half 2021 results: Revenue: €1.36m (down 16% from 1H 2020). Net loss: €7.99m (loss widened 3.8% from 1H 2020).공시 • Jul 03Advicenne Receives Medicines and Healthcare products Regulatory Agency Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTAAdvicenne announced that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sibnayal™ (ADV7103) in the UK, for the treatment of distal renal tubular acidosis (dRTA). With this authorization, and following the recent approval by the European Commission to market Sibnayal™ for the treatment of dRTA in the European Union, Advicenne is now able to bring to market in the EU and the UK the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. Advicenne now has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition in Europe. Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.공시 • Jun 24Advicenne S.A. announced that it has received €9.42128 million in fundingAdvicenne S.A. (ENXTPA:ADVIC) announced a private placement of 1,319,507 new ordinary shares at a price of €7.14 per share for gross proceeds of approximately €9,421,280 on June 23, 2021. The transaction included participation from certain investors.Executive Departure • May 12Chief Executive Officer Peter Meeus has left the companyOn the 3rd of May, Peter Meeus' tenure as Chief Executive Officer of the company ended after less than a year in the role. We don't have any record of a personal shareholding under Peter's name. Peter is the only executive to leave the company over the last 12 months. Under Peter's leadership, the company delivered a total shareholder return of -22%.공시 • May 04Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal™) and announces Leadership Changes to support CommercialisationAdvicenne announced that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal™), for the treatment of distal renal tubular acidosis (dRTA). This approval makes ADV7103 the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. With the approval, Advicenne has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition affecting no more than 1 to 2 individuals per 10,000 people in Europe. The EC marketing authorisation will be valid in all EU Member States, in the United Kingdom as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway). ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages. About dRTA: Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure. Whether genetic or acquired as a consequence of an immune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States. About the Phase III European program in dRTA (B21CS pivotal study & B22CS extension study): B21CS was a multicenter pivotal study that enrolled 37 patients suffering from dRTA, including adults, adolescents, children and infants and aimed to assess the efficacy of ADV7103 compared to Standard of Care (SoC) on blood and urine biomarkers of metabolic acidosis. Patients took the SoC treatment for five consecutive days followed by five days of two daily doses of ADV7103, an innovative prolonged-release granule combination of potassium citrate and potassium bicarbonate. Based on the blood and urine parameters, the study results demonstrated the effectiveness and suggested clinical benefit of ADV7103 in dRTA patients in comparison with the SoC. The B22CS extension study was an open-label clinical study that confirmed the efficacy and safety of ADV7103 after 24 months of treatment. ADV7103 has successfully met the primary and secondary endpoints of the study and demonstrated its ability to treat biological disorders caused by dRTA.공시 • Mar 21Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal™) for dRTA in EuropeAdvicenne announced that it anticipates imminent European Marketing Authorization for its lead product, ADV7103 (Sibnayal™). Concurrently, and in order to prevent any delays to the potential patient availability of the product, the Company has decided to withdraw its application for the Orphan Drug Designation (ODD), as it was informed by EMA that additional data would be needed to grant /confirm ODD status. As such, Advicenne will be able to make ADV7103 available to patients suffering from dRTA in Europe in the shortest possible timeframe. In Europe, dRTA is classified as an orphan condition affecting less than 2.1 per 10,000 people. The approval will make ADV7103 the first and only label-approved drug for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older. Given the debilitating consequences of the condition, the Company is convinced that with ADV7103 it has the opportunity to make a significant difference to patients sufferering from dRTA. ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages.공시 • Feb 19+ 1 more updateAdvicenne S.A. Provides an Update as its Operations EvolveAdvicenne provides an update on the overall progress of the Company. In Europe, with the recent positive CHMP Opinion for its lead medicine ADV7103-Sibnayal™, Advicenne should receive the EMA Marketing Authorization (MAA) for Sibnayal™ soon. The company is currently pursuing discussions with several partners for its commercialization in most countries of the European Community. Meanwhile the clinical program in cystinuria in the EU is progressing. In spite of the hurdles encountered due to the ongoing COVID-19 crisis, the submission for Marketing Authorization is expected by late 2022. Advicenne has been able to maintain a satisfactory level of activity, and the team has been doing a great job in all the aspects of the Sibnayal pre-launch, from market access to manufacturing and securement of the supply chain. In the US, Advicenne Inc, Advicenne’s US affiliate, has made significant progress in building a team of highly qualified professionals. The pivotal Phase III ARENA trial of ADV7103 for distal Renal Tubular Acidosis (dRTA) is resuming. The submission for Marketing Authorization is expected in late 2022. Meanwhile the launch of Ozalin™ by Primex under an exclusive license is progressing. Advicenne is confident in the continuous positive execution of the €40 million licensing deal signed in 2016. Focus and streamlining, as well as effective cost management are practices put in place by the Company during these difficult times. The Company was able to secure €4.3 million of non-dilutive financing through a PGE (French state guaranteed loan) at the end of 2020. Thanks to the positive evolution of the company a number of financing options are now open to secure the development of the Company in the mid term.Is New 90 Day High Low • Feb 06New 90-day high: €12.10The company is up 90% from its price of €6.36 on 06 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €74.48 per share.Is New 90 Day High Low • Jan 20New 90-day high: €11.70The company is up 96% from its price of €5.96 on 21 October 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €71.72 per share.공시 • Jan 08+ 1 more updateAdvicenne Appoints Peter Meeus as Chief Executive Officer, Effective February 15, 2021Advicenne announced the appointment of Peter Meeus as Chief Executive Officer of Advicenne, effective February 15, 2021 . Peter Meeus brings over 25 years of experience in the life sciences industry to Advicenne. Prior to joining Advicenne, Peter Meeus served as Senior Vice-President and Head of Product & Portfolio Strategy at Biocon Biologics, based in Singapore. Earlier, he was Head of Region Europe at Shire, before its acquisition by Takeda, and had a long career at Novartis and Novo Nordisk A/S, culminating in his role as Vice-President and Head of their UK and Irish Business.공시 • Dec 11Advicenne Receives Positive CHMP Opinion Recommending Approval of ADV7103 (sibnayal) for the Treatment of Distal Renal Tubular Acidosis (dRTA)Advicenne announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of its lead product ADV7103 (Sibnayal) as therapy for distal renal tubular acidosis (dRTA). The European Commission (EC) will now review the CHMP recommendation and a final decision on the Marketing Authorisation of ADV7103 in the European Union is expected in the coming weeks/months. This CHMP positive opinion is based on results of a pivotal Phase III trial (B21CS) and its twenty-four-month extension study (B22CS) conducted in adult and pediatric patients with dRTA demonstrating the clinically relevant therapeutic effect of ADV7103. While the standard of care (SoC) medicine requires three to six daily intakes including during night, ADV7103 treatment consists of only two doses per day and provides complete night-time coverage for patients. In addition, gastrointestinal tolerability was improved. Plasma potassium and urinary calcium was normalized. In order to make ADV7103 quickly and broadly available in all EU countries, Advicenne has decided to set up partnerships with specialized distributors. This approach will allow Advicenne to allocate its resources on the clinical development of ADV7103 in the United States and to develop its second indication for the medicine in cystinuria.Is New 90 Day High Low • Dec 04New 90-day high: €8.46The company is up 18% from its price of €7.18 on 04 September 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €60.80 per share.Is New 90 Day High Low • Nov 19New 90-day high: €7.58The company is up 5.0% from its price of €7.24 on 20 August 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €56.73 per share.Is New 90 Day High Low • Oct 19New 90-day low: €5.96The company is down 18% from its price of €7.26 on 21 July 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.43 per share.Is New 90 Day High Low • Sep 30New 90-day low: €6.46The company is down 12% from its price of €7.32 on 02 July 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €35.89 per share.Reported Earnings • Sep 29First half earnings releasedOver the last 12 months the company has reported total losses of €14.6m, with losses widening by 81% from the prior year. Total revenue was €2.55m over the last 12 months, down 64% from the prior year.매출 및 비용 세부 내역Advicenne가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이DB:3MM 매출, 비용 및 순이익 (EUR Millions)날짜매출순이익일반관리비연구개발비31 Dec 256-103030 Sep 256-102030 Jun 256-102031 Mar 256-102031 Dec 245-103030 Sep 246-93-130 Jun 246-93-231 Mar 246-83-131 Dec 235-83030 Sep 235-82-430 Jun 233-104631 Mar 233-115731 Dec 224-103030 Sep 223-105730 Jun 224-95731 Mar 224-116831 Dec 214-126930 Sep 214-145630 Jun 214-158831 Mar 214-159831 Dec 203-159830 Sep 203-15111130 Jun 203-154131 Mar 202-144031 Dec 193-148930 Sep 192-116530 Jun 192-85131 Mar 191-64131 Dec 181-53030 Sep 182-63330 Jun 182-74631 Mar 182-74531 Dec 173-63530 Sep 172-53430 Jun 172-42431 Mar 172-42431 Dec 162-42331 Dec 153-210양질의 수익: 3MM 은(는) 현재 수익성이 없습니다.이익 마진 증가: 3MM는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: 3MM는 수익성이 없지만 지난 5년 동안 연평균 10.2%의 속도로 손실을 줄였습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 3MM의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: 3MM은 수익성이 없어 지난 해 수익 성장률을 Pharmaceuticals 업계(16.1%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: 3MM의 부채가 자산을 초과하여 자본 수익률을 계산하기 어렵습니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/25 06:46종가2026/05/25 00:00수익2025/12/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Advicenne S.A.는 3명의 분석가가 다루고 있습니다. 이 중 1명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Stephanie LefebvreGilbert DupontJean-Pierre LozaIn Extenso Financement & MarchéJean-Pierre TabartTPICAP Midcap
공시 • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026
공시 • Nov 29Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025
Reported Earnings • Apr 10Full year 2023 earnings released: €0.67 loss per share (vs €1.16 loss in FY 2022)Full year 2023 results: €0.67 loss per share (improved from €1.16 loss in FY 2022). Revenue: €3.48m (up 18% from FY 2022). Net loss: €7.03m (loss narrowed 39% from FY 2022). Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.
공시 • Dec 29+ 2 more updatesAdvicenne S.A. to Report First Half, 2024 Results on Sep 18, 2024Advicenne S.A. announced that they will report first half, 2024 results on Sep 18, 2024
공시 • Nov 30+ 2 more updatesAdvicenne S.A. to Report Fiscal Year 2022 Results on Mar 30, 2023Advicenne S.A. announced that they will report fiscal year 2022 results After-Market on Mar 30, 2023
Reported Earnings • Oct 01First half 2021 earnings released: €0.93 loss per share (vs €0.92 loss in 1H 2020)The company reported a poor first half result with increased losses, weaker revenues and weaker control over costs. First half 2021 results: Revenue: €1.36m (down 16% from 1H 2020). Net loss: €7.99m (loss widened 3.8% from 1H 2020).
공시 • May 23Advicenne S.A. Announces Board ChangesAdvicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco).
Board Change • May 20Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
공시 • Apr 16Advicenne S.A., Annual General Meeting, May 21, 2026Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris France
공시 • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026
공시 • Jan 19Advicenne S.A. Accepts for Review the New Drug Application for Sibnayal, A Fixed Combination of Potassium Citrate and Potassium Bicarbonate for the Treatment of Distal Renal Tubular AcidosisAdvicenne announced that the FDA (Food and Drug Administration) has accepted for review the New Drug Application (NDA) for Sibnayal®? (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal Renal Tubular Acidosis (dRTA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026. Following the submission of the New Drug Application (N DA) dossier on November 2, 2025, the U.S. FDA completed its standard 60-day filing review. During this period, Advicenne satisfactorily addressed several questions raised by the Agency. As agreed with the FDA, the 505(b)(2) application incorporates the European clinical studies that also underpin the recently renewed Marketing Authorization dossier in Europe.
공시 • Jan 12Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European UnionAdvicenne obtains the renewal of its Marketing Authorization (MA) for Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the European Union. The European Medicines Agency (EMA) has renewed the marketing authorization for Sibnayal™ starting in January 2026. This renewal, which is mandatory five years after the initial issuance, definitively validates the marketing authorization. It marks a major milestone for the continued commercial development of Sibnayal®® in Europe. It is part of a busy regulatory program, with marketing authorization obtained in the Kingdom of Saudi Arabia in July 2025 and, more recently, the filing of a registration application with the US Food & Drug Administration.
Board Change • Dec 30Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
공시 • Nov 05Advicenne Submitted to US FDA the Registration Application for Sibnayal® in dRTA TreatmentAdvicenne announced the submission of the registration application for Sibnayal® (fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) to the US Food and Drug Administration (US FDA). Sibnayal®® has been designated orphan drug in dRTA in the USA. The evaluation of the dossier should take approximately 12 months. The company will communicate on the main stages of the evaluation process as well as on the expected date of the US authorities' decision, which should be known within a few weeks.
공시 • Jul 29Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal®? in Saudi ArabiaAdvicenne obtains marketing authorization (MA) and reimbursement status for Sibnayal®? (a fixed combination of potassium citrate and potassium bicarbonate) in the Kingdom of Saudi Arabia (KSA). Marketing authorization for Sibnayal™? (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. Furthermore, Saudi authorities have agreed a reimbursement rate in line with the best European pricing. This achievement results of a close collaboration between Advicenne and its local partner, Taiba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taiba Healthcare will manage local marketing activities. The incidence of dRTA is higher in Gulf countries than in Europe or the United States, and prevalence in KSA could be estimated around 600 to 800 patients. Sibnayal®®? is already prescribed through early access programs in several Gulf countries outside Saudi Arabia. This milestone paves the way for registrations in GCC countries where the application is filed.
공시 • Apr 08Advicenne S.A., Annual General Meeting, May 15, 2025Advicenne S.A., Annual General Meeting, May 15, 2025. Location: 2 rue de la chaussee d antin, paris France
공시 • Jan 29Advicenne Reaches A Significant Milestone with the Us FDA in the Development of Adv7103 in CystinuriaAdvicenne provided an update on recent exchanges with the U.S. FDA about the development of ADV7103 in cystinuria, and announces that it has reached an important milestone. As previously stated, the company has engaged in a new round of discussions with the US FDA to finalize the development plan for ADV7103 in cystinuria in the United States. During the latest meeting, Advicenne has presented a set of data, with the active presence of American opinion leaders, and the “International Cystinuria Foundation”, the main cystinuria patient group, specifically: The preliminary clinical results obtained in Europe in cystinuria patients, The European and American expert opinions on medical needs in this rare kidney disease, A proposed clinical development plan with a biological endpoint. Following this meeting, the FDA accepted Advicenne’s proposition of a biological primary endpoint for the evaluation of ADV7103 in cystinuria; a significant step in preparing for a clinical trial of limited duration and number of patients. Advicenne is now preparing the submission of the final draft of the pivotal trial in cystinuria to the FDA. The choice of the biological primary endpoint should enable the company to enroll patients both in the United States and Europe, and to consider filing simultaneously registration applications in both territories. ADV7103 has orphan drug status in the cystinuria indication in both Europe and the USA. Cystinuria affects around 30,000 patients in the US and 40,000 in Europe and represents a significant potential market for ADV7103.
공시 • Nov 29Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025
Board Change • Oct 03Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
공시 • Oct 01Advicenne Achieves Major Milestones in the US Due to Several Positive FDA Opinion on ADV7103Advicenne announced the achievement of major milestones in the development program of its ADV7103 drug in the U.S, and the search for commercial partners. ADV7103 in dRTA (Distal Renal Tubular Acidosis): European data deemed satisfactory by the FDA for filing without additional clinical studies in the US. After numerous exchanges with experts from the US Food & Drug Administration (FDA), the Agency has concluded that European clinical data can be used to support an application for registration in dTRA. As a result, Advicenne will not conduct a specific clinical study in the U.S., significantly reducing the time and cost required to file a marketing authorization application in the U.S. for this indication. The FDA's positive opinion was based on consideration of all the clinical data available from the European clinical program. Specifically, the pivotal phase III study (B21CS) and the long-term safety extension study (B22CS), which provide Advicenne with clinical data on efficacy and safety for patients followed over a period of more than 6 years. These studies, presented to the European Renal Association(ERA) and the European Society of Pediatric Nephrology (ESPN), are supplemented by data from real-life cohorts (Real World Evidence - RWE), and extensive European pharmacovigilance data. Following an initial phase of discussions, the FDA considered that the drug's safety data met its requirements in terms of long-term tolerability. This first phase opened the path to a discussion on the relevance of efficacy data from these same studies. This was the purpose of the second phase of exchanges with complementary analysis data from the studies. ADV7103 has orphan drug status in the dRTA indication in the US. The results of the above studies will be reported at an analysts' meeting to be scheduled shortly. ADV7103 in cystinuria: preparation for clinical development in consultation with the FDA. ADV7103 has been granted orphan drug designation (ODD) for the treatment of cystinuria in March 2024, adding to the existing orphan drug status for this indication in Europe. This validated Advicenne's regulatory and clinical strategy with the FDA. The ODD application was supported by preliminary clinical results in European patients with cystinuria and extensive data on the population size and expert opinion on the unmet need in this indication. Following this success, the Company wishes to discuss the proposed clinical development plan that will serve as the basis for a marketing authorization in this indication. A round of discussions will be launched before the end of the year. This clinical program proposed has strong support from experts in this condition from both Europe and the United States, as well as from the International Cystinuria Foundation, representing the patient population. There is broad agreement that alkalinization is a cornerstone of treatment and that there is no satisfactory alkalinizing treatment that provides well tolerated, 24-hour pH control, indicated by recent data from the European Cystinuria Registry showing only on fourth of cystinuria patients followed in Europe have a urinary pH above 7.5, the therapeutic target set by international recommendations. Pending the conclusion of discussions with the FDA and agreement on the clinical program, Advicenne plans to initiate a clinical trial in cystinuria. This study would recruit patients simultaneously in the United States and Europe and enable a registration application to be filed in both markets. In Europe, ADV7103 also has orphan drug status in this indication. The recent news flow is expected to generate further interest, which the Company intends to pursue actively, particularly from the end of 2024.
Reported Earnings • Apr 10Full year 2023 earnings released: €0.67 loss per share (vs €1.16 loss in FY 2022)Full year 2023 results: €0.67 loss per share (improved from €1.16 loss in FY 2022). Revenue: €3.48m (up 18% from FY 2022). Net loss: €7.03m (loss narrowed 39% from FY 2022). Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.
New Risk • Mar 29New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-€14m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (24% increase in shares outstanding). Revenue is less than US$5m (€2.7m revenue, or US$3.0m). Market cap is less than US$100m (€25.6m market cap, or US$27.7m).
Board Change • Mar 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Board Change • Jan 24Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
공시 • Dec 29+ 2 more updatesAdvicenne S.A. to Report First Half, 2024 Results on Sep 18, 2024Advicenne S.A. announced that they will report first half, 2024 results on Sep 18, 2024
공시 • Nov 30+ 2 more updatesAdvicenne S.A. to Report Fiscal Year 2022 Results on Mar 30, 2023Advicenne S.A. announced that they will report fiscal year 2022 results After-Market on Mar 30, 2023
공시 • Jun 30Advicenne Announces Commercial Launch of Sibnayal in Great BritainAdvicenne S.A. announced that Sibnayal, combination of potassium citrate and potassium bicarbonate, has been made available to patients suffering from distal Renal Tubular Acidosis (dRTA) in Great Britain. Sibnayal has been approved in Great Britain since July 2021. Sibnayal has been added on the Department of Health list of drugs and is immediately available for doctors and patients in its indication. Advicenne has obtained, from the National Health Service (NHS) the selling price of Sibnayal® in Great-Britain and is now actively working to provide the National Institute for Health and Care Excellence (NICE) with additional information allowing positive opinion on the prescription’s guidance of Sibnayal. The next session with NICE is planned on August 4.
공시 • Jun 10Advicenne S.A. Announces Executive ChangesAdvicenne S.A. announced that Mr. André Ulmann as a non-voting director, for a three-year term. The Board of Directors meeting held after this Meeting appointed as Chairman of the Board of Directors Mr. Philippe Boucheron, who will continue to serve as Chairman of the Remuneration Committee. The Board also noted the change in the permanent representative of Bpifrance Investissement, in the person of Mr. Thibaut Roulon who will also be member of the Audit Committee chaired by Mrs. Catherine Dunand. The Board of Directors of Advicenne is now composed of the following members: Philippe Boucheron, Director, Chairman of the Board; Mr. Didier Laurens, director, Chief Executive Officer; Cemag Invest, represented by Catherine Dunand, Director; Bpifrance Investissement, represented by Mr. Thibaut Roulon, Director; Irdi Soridec Gestion, represented by Mr. Jean-Michel Petit, director; Mrs. Charlotte Sibley, independent director; Mrs. Hege Hellstrom, independent director; Mr. André Ulmann, observer. The Combined General Meeting was an opportunity to present the progress of the Company's various programs and strategy.
공시 • Apr 22Advicenne Appoints Philippe Boucheron as Chairman of Its Board of DirectorsAdvicenne announced the appointment of Philippe BOUCHERON as Chairman of the Board of Directors following the next Annual General Meeting to be held on June 9, 2022. This appointment follows David Horn SOLOMON’s decision not to seek the renewal of his term as director, entailing therefore the termination of his duties as Chairman of the Board of Directors from that same date.
공시 • Mar 31Advicenne Announces the Release of Results of a Study Showing Improved Quality of Life in Patients Living With DRTa and Treated by ADV7103Advicenne announced the publication, in the peer-reviewed journal Orphanet Journal of Rare Disease, results of a study showing improvement in the long-term quality of life in patients with distal Renal Tubular Acidosis (dRTA) and treated with ADV7103. The patients' quality of life was assessed through interviews and conducted as part of the clinical development of ADV7103 after more than 5 years of treatment on average (62 +/- 6 months). The level of treatment satisfaction was 9 on a scale of 10 and the treatment met or exceeded expectations in 74% of patients (14 patients out of 17). These results confirm the interest of ADV7103 in the treatment of dRTA and the advantage of a bi-daily dosing compared to the usual management of this disease.
공시 • Jan 25Advicenne Ordinary Shareholders' Meeting Approves Delisting from Regulated Market of Euronext BrusselsThe ordinary shareholders' meeting of Advicenne S.A. held on January 24, 2022, approved the proposed transfer of the listing of the Company's shares from the regulated market of Euronext Paris (Compartment C) to the multilateral trading facility of Euronext Growth Paris ('Euronext Growth Paris'), the proposed delisting of its shares from the regulated market of Euronext Brussels, and empowered the board of directors to carry out these transfer and concomitant delisting.
Breakeven Date Change • Jan 14Forecast to breakeven in 2023The analyst covering Advicenne expects the company to break even for the first time. New forecast suggests losses will reduce by 61% per year to 2022. The company is expected to make a profit of €7.21m in 2023. Average annual earnings growth of 103% is required to achieve expected profit on schedule.
공시 • Dec 20Advicenne Announces Positive Opinion from the French Transparency Commission (HAS) for Its Drug Sibnayal™ in dRTAAdvicenne announced is has received a positive opinion from the French Transparency Commission (HAS) with its lead asset, Sibnayal™ eligible for reimbursement with a Moderate Level SMR (Medical Rendered Service) and a Level IV ASMR (Medical Rendered Service Improvement), in the treatment of distal Renal Tubular Acidosis (dRTA) in adults, adolescents and children over the age of 1. This decision makes Sibnayal™ the only specialty pharmaceutical product reimbursed in the treatment of dRTA in France, which will significantly ease access to treatment of the disease for both patients and their doctors. The French Transparency Commission (HAS " Haute Autorité de Santé), in its opinion, acknowledges thecontribution of the twice-daily dosing formulation of Sibnayal™ which significantly improves the quality of life of patients as well as compliance to long-term treatment plans. These factors contribute to the continuous improvement of disease indicators, particularly bone mineral density, as shown by the clinical development of Sibnayal™ over a period of at least 4 years.
Reported Earnings • Oct 01First half 2021 earnings released: €0.93 loss per share (vs €0.92 loss in 1H 2020)The company reported a poor first half result with increased losses, weaker revenues and weaker control over costs. First half 2021 results: Revenue: €1.36m (down 16% from 1H 2020). Net loss: €7.99m (loss widened 3.8% from 1H 2020).
공시 • Jul 03Advicenne Receives Medicines and Healthcare products Regulatory Agency Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTAAdvicenne announced that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sibnayal™ (ADV7103) in the UK, for the treatment of distal renal tubular acidosis (dRTA). With this authorization, and following the recent approval by the European Commission to market Sibnayal™ for the treatment of dRTA in the European Union, Advicenne is now able to bring to market in the EU and the UK the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. Advicenne now has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition in Europe. Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.
공시 • Jun 24Advicenne S.A. announced that it has received €9.42128 million in fundingAdvicenne S.A. (ENXTPA:ADVIC) announced a private placement of 1,319,507 new ordinary shares at a price of €7.14 per share for gross proceeds of approximately €9,421,280 on June 23, 2021. The transaction included participation from certain investors.
Executive Departure • May 12Chief Executive Officer Peter Meeus has left the companyOn the 3rd of May, Peter Meeus' tenure as Chief Executive Officer of the company ended after less than a year in the role. We don't have any record of a personal shareholding under Peter's name. Peter is the only executive to leave the company over the last 12 months. Under Peter's leadership, the company delivered a total shareholder return of -22%.
공시 • May 04Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal™) and announces Leadership Changes to support CommercialisationAdvicenne announced that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal™), for the treatment of distal renal tubular acidosis (dRTA). This approval makes ADV7103 the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. With the approval, Advicenne has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition affecting no more than 1 to 2 individuals per 10,000 people in Europe. The EC marketing authorisation will be valid in all EU Member States, in the United Kingdom as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway). ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages. About dRTA: Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure. Whether genetic or acquired as a consequence of an immune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States. About the Phase III European program in dRTA (B21CS pivotal study & B22CS extension study): B21CS was a multicenter pivotal study that enrolled 37 patients suffering from dRTA, including adults, adolescents, children and infants and aimed to assess the efficacy of ADV7103 compared to Standard of Care (SoC) on blood and urine biomarkers of metabolic acidosis. Patients took the SoC treatment for five consecutive days followed by five days of two daily doses of ADV7103, an innovative prolonged-release granule combination of potassium citrate and potassium bicarbonate. Based on the blood and urine parameters, the study results demonstrated the effectiveness and suggested clinical benefit of ADV7103 in dRTA patients in comparison with the SoC. The B22CS extension study was an open-label clinical study that confirmed the efficacy and safety of ADV7103 after 24 months of treatment. ADV7103 has successfully met the primary and secondary endpoints of the study and demonstrated its ability to treat biological disorders caused by dRTA.
공시 • Mar 21Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal™) for dRTA in EuropeAdvicenne announced that it anticipates imminent European Marketing Authorization for its lead product, ADV7103 (Sibnayal™). Concurrently, and in order to prevent any delays to the potential patient availability of the product, the Company has decided to withdraw its application for the Orphan Drug Designation (ODD), as it was informed by EMA that additional data would be needed to grant /confirm ODD status. As such, Advicenne will be able to make ADV7103 available to patients suffering from dRTA in Europe in the shortest possible timeframe. In Europe, dRTA is classified as an orphan condition affecting less than 2.1 per 10,000 people. The approval will make ADV7103 the first and only label-approved drug for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older. Given the debilitating consequences of the condition, the Company is convinced that with ADV7103 it has the opportunity to make a significant difference to patients sufferering from dRTA. ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages.
공시 • Feb 19+ 1 more updateAdvicenne S.A. Provides an Update as its Operations EvolveAdvicenne provides an update on the overall progress of the Company. In Europe, with the recent positive CHMP Opinion for its lead medicine ADV7103-Sibnayal™, Advicenne should receive the EMA Marketing Authorization (MAA) for Sibnayal™ soon. The company is currently pursuing discussions with several partners for its commercialization in most countries of the European Community. Meanwhile the clinical program in cystinuria in the EU is progressing. In spite of the hurdles encountered due to the ongoing COVID-19 crisis, the submission for Marketing Authorization is expected by late 2022. Advicenne has been able to maintain a satisfactory level of activity, and the team has been doing a great job in all the aspects of the Sibnayal pre-launch, from market access to manufacturing and securement of the supply chain. In the US, Advicenne Inc, Advicenne’s US affiliate, has made significant progress in building a team of highly qualified professionals. The pivotal Phase III ARENA trial of ADV7103 for distal Renal Tubular Acidosis (dRTA) is resuming. The submission for Marketing Authorization is expected in late 2022. Meanwhile the launch of Ozalin™ by Primex under an exclusive license is progressing. Advicenne is confident in the continuous positive execution of the €40 million licensing deal signed in 2016. Focus and streamlining, as well as effective cost management are practices put in place by the Company during these difficult times. The Company was able to secure €4.3 million of non-dilutive financing through a PGE (French state guaranteed loan) at the end of 2020. Thanks to the positive evolution of the company a number of financing options are now open to secure the development of the Company in the mid term.
Is New 90 Day High Low • Feb 06New 90-day high: €12.10The company is up 90% from its price of €6.36 on 06 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €74.48 per share.
Is New 90 Day High Low • Jan 20New 90-day high: €11.70The company is up 96% from its price of €5.96 on 21 October 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €71.72 per share.
공시 • Jan 08+ 1 more updateAdvicenne Appoints Peter Meeus as Chief Executive Officer, Effective February 15, 2021Advicenne announced the appointment of Peter Meeus as Chief Executive Officer of Advicenne, effective February 15, 2021 . Peter Meeus brings over 25 years of experience in the life sciences industry to Advicenne. Prior to joining Advicenne, Peter Meeus served as Senior Vice-President and Head of Product & Portfolio Strategy at Biocon Biologics, based in Singapore. Earlier, he was Head of Region Europe at Shire, before its acquisition by Takeda, and had a long career at Novartis and Novo Nordisk A/S, culminating in his role as Vice-President and Head of their UK and Irish Business.
공시 • Dec 11Advicenne Receives Positive CHMP Opinion Recommending Approval of ADV7103 (sibnayal) for the Treatment of Distal Renal Tubular Acidosis (dRTA)Advicenne announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of its lead product ADV7103 (Sibnayal) as therapy for distal renal tubular acidosis (dRTA). The European Commission (EC) will now review the CHMP recommendation and a final decision on the Marketing Authorisation of ADV7103 in the European Union is expected in the coming weeks/months. This CHMP positive opinion is based on results of a pivotal Phase III trial (B21CS) and its twenty-four-month extension study (B22CS) conducted in adult and pediatric patients with dRTA demonstrating the clinically relevant therapeutic effect of ADV7103. While the standard of care (SoC) medicine requires three to six daily intakes including during night, ADV7103 treatment consists of only two doses per day and provides complete night-time coverage for patients. In addition, gastrointestinal tolerability was improved. Plasma potassium and urinary calcium was normalized. In order to make ADV7103 quickly and broadly available in all EU countries, Advicenne has decided to set up partnerships with specialized distributors. This approach will allow Advicenne to allocate its resources on the clinical development of ADV7103 in the United States and to develop its second indication for the medicine in cystinuria.
Is New 90 Day High Low • Dec 04New 90-day high: €8.46The company is up 18% from its price of €7.18 on 04 September 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €60.80 per share.
Is New 90 Day High Low • Nov 19New 90-day high: €7.58The company is up 5.0% from its price of €7.24 on 20 August 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €56.73 per share.
Is New 90 Day High Low • Oct 19New 90-day low: €5.96The company is down 18% from its price of €7.26 on 21 July 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.43 per share.
Is New 90 Day High Low • Sep 30New 90-day low: €6.46The company is down 12% from its price of €7.32 on 02 July 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €35.89 per share.
Reported Earnings • Sep 29First half earnings releasedOver the last 12 months the company has reported total losses of €14.6m, with losses widening by 81% from the prior year. Total revenue was €2.55m over the last 12 months, down 64% from the prior year.