Annuncio • May 23
Advicenne S.A. Announces Board Changes Advicenne 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). New Risk • May 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€4.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€4.1m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€26m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€2.4m net loss in 2 years). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (€12.3m market cap, or US$14.5m). Breakeven Date Change • May 11
No longer forecast to breakeven The 2 analysts covering Advicenne no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €650.0k in 2027. New consensus forecast suggests the company will make a loss of €2.40m in 2027. Major Estimate Revision • May 07
Consensus EPS estimates increase from loss to €0.10 profit, revenue downgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from €8.05m to €7.75m. EPS estimate of -€0.055 up from expected loss of €0.10 per share previously. Pharmaceuticals industry in France expected to see average net income growth of 39% next year. Consensus price target of €3.50 unchanged from last update. Share price fell 32% to €0.86 over the past week. New Risk • May 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 13% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€26m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-€4.1m). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (€11.4m market cap, or US$13.4m). Annuncio • Apr 16
Advicenne S.A., Annual General Meeting, May 21, 2026 Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris France Annuncio • Jan 19
Advicenne 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 Acidosis Advicenne 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. Annuncio • Jan 12
Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European Union Advicenne 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. Annuncio • Nov 05
Advicenne Submitted to US FDA the Registration Application for Sibnayal® in dRTA Treatment Advicenne 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. Breakeven Date Change • Sep 25
Forecast to breakeven in 2027 The 2 analysts covering Advicenne expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 39% per year to 2026. The company is expected to make a profit of €673.3k in 2027. Average annual earnings growth of 76% is required to achieve expected profit on schedule. New Risk • Sep 24
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: €10.0m Forecast net loss in 2 years: €1.5m 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: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Negative equity (-€19m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€1.5m net loss in 2 years). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (€25.7m market cap, or US$30.2m). New Risk • Sep 23
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 11% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€19m). Minor Risks Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (€22.5m market cap, or US$26.6m). Breakeven Date Change • Sep 23
Forecast to breakeven in 2027 The 2 analysts covering Advicenne expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 39% per year to 2026. The company is expected to make a profit of €673.3k in 2027. Average annual earnings growth of 66% is required to achieve expected profit on schedule. New Risk • Jul 29
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 15% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Negative equity (-€19m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€100k net loss in 3 years). Share price has been volatile over the past 3 months (8.4% average weekly change). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (€19.8m market cap, or US$23.0m). Annuncio • Jul 29
Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal®? in Saudi Arabia Advicenne 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. Major Estimate Revision • Jul 01
Consensus revenue estimates increase by 32%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from €4.00m to €5.30m. EPS estimate fell from -€0.315 to -€0.36 per share. Pharmaceuticals industry in France expected to see average net income growth of 45% next year. Consensus price target of €4.00 unchanged from last update. Share price fell 12% to €1.37 over the past week. New Risk • Jun 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 French stocks, typically moving 7.1% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-€853k free cash flow). Negative equity (-€19m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€3.0m net loss in 2 years). Share price has been volatile over the past 3 months (7.1% average weekly change). Market cap is less than US$100m (€20.1m market cap, or US$23.2m). Reported Earnings • May 05
Full year 2024 earnings released Full year 2024 results: Revenue: €5.73m (up 75% from FY 2023). Net loss: €9.95m (loss widened 42% from FY 2023). Revenue is forecast to grow 16% p.a. on average during the next 2 years, compared to a 4.8% growth forecast for the Pharmaceuticals industry in France. Annuncio • Apr 08
Advicenne S.A., Annual General Meeting, May 15, 2025 Advicenne S.A., Annual General Meeting, May 15, 2025. Location: 2 rue de la chaussee d antin, paris France New Risk • Apr 06
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. 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 Risk Negative equity (-€17m). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (€4.0m net loss in 2 years). Revenue is less than US$5m (€3.3m revenue, or US$3.7m). Market cap is less than US$100m (€19.0m market cap, or US$20.9m). Annuncio • Jan 29
Advicenne Reaches A Significant Milestone with the Us FDA in the Development of Adv7103 in Cystinuria Advicenne 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. Major Estimate Revision • Dec 22
Consensus revenue estimates decrease by 18%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from €4.45m to €3.66m. EPS estimate increased from -€0.585 to -€0.505 per share. Pharmaceuticals industry in France expected to see average net income growth of 13% next year. Consensus price target down from €5.25 to €4.00. Share price rose 8.4% to €1.84 over the past week. Breakeven Date Change • Dec 20
No longer forecast to breakeven The 2 analysts covering Advicenne no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €9.08m in 2025. New consensus forecast suggests the company will make a loss of €3.95m in 2026. Annuncio • Nov 29
Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025 Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025 Annuncio • Oct 01
Advicenne Achieves Major Milestones in the US Due to Several Positive FDA Opinion on ADV7103 Advicenne 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. Major Estimate Revision • Jul 10
Consensus revenue estimates increase by 12% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from €4.20m to €4.72m. EPS estimate unchanged from -€0.64 at last update. Pharmaceuticals industry in France expected to see average net income growth of 20% next year. Consensus price target of €6.90 unchanged from last update. Share price was steady at €2.02 over the past week. Reported Earnings • Apr 09
Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind 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 missed analyst estimates by 20%. Earnings per share (EPS) exceeded analyst estimates by 9.4%. Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 4.6% growth forecast for the Pharmaceuticals industry in France. 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 47% per year, which means it is significantly lagging earnings. New Risk • Mar 29
New minor risk - Financial data availability The 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 (19% 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). New Risk • Jan 25
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 11% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€14m). Minor Risks 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 (€25.0m market cap, or US$27.2m). Board Change • Jan 24
Less than half of directors are independent Following 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. Price Target Changed • Jan 14
Price target decreased to €16.90 Down from €21.50, the current price target is provided by 1 analyst. New target price is 98% above last closing price of €8.55. Stock is down 19% over the past year. The company is forecast to post a net loss per share of €0.23 next year compared to a net loss per share of €1.73 last year. Breakeven Date Change • Jan 14
Forecast to breakeven in 2023 The 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. Reported Earnings • Oct 01
First 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). Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has only fallen by 19% per year, which means it has not declined as severely as earnings. Major Estimate Revision • Jun 25
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 losses forecast to reduce from -€2.30 to -€2.01 per share. Revenue forecast unchanged from €2.10m at last update. Pharmaceuticals industry in France expected to see average net income decline 18% next year. Consensus price target of €21.50 unchanged from last update. Share price fell 20% to €7.12 over the past week. Executive Departure • May 12
Chief Executive Officer Peter Meeus has left the company On 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 -21%. Is New 90 Day High Low • Feb 06
New 90-day high: €12.95 The company is up 117% from its price of €5.96 on 06 November 2020. The French market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €73.52 per share. Is New 90 Day High Low • Jan 19
New 90-day high: €12.20 The company is up 103% from its price of €6.00 on 21 October 2020. The French market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €73.52 per share. Is New 90 Day High Low • Dec 03
New 90-day high: €8.54 The company is up 21% from its price of €7.04 on 04 September 2020. The French market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €60.30 per share. Is New 90 Day High Low • Nov 17
New 90-day high: €7.62 The company is up 4.0% from its price of €7.36 on 18 August 2020. The French market is up 9.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Pharmaceuticals industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €60.30 per share. Is New 90 Day High Low • Oct 16
New 90-day low: €6.20 The company is down 13% from its price of €7.10 on 17 July 2020. The French market is down 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.93 per share. Is New 90 Day High Low • Sep 30
New 90-day low: €6.48 The company is down 12% from its price of €7.34 on 02 July 2020. The French market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €35.43 per share. Reported Earnings • Sep 29
First half earnings released Over 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. Major Estimate Revision • Sep 26
Analysts lower revenue estimates to €3.31m The 2020 consensus revenue estimate decreased from €13.3m. Earnings per share (EPS) also decreased, with analysts lowering their estimates from -€0.53 to -€2.91 for the same period. The Pharmaceuticals industry in France is expected to see an average net income growth of 5.3% next year. The consensus price target of €24.93 was unchanged from the last update. Share price is down by 3.9% to €6.82 over the past week.