View ValuationHyloris Pharmaceuticals 향후 성장Future 기준 점검 6/6Hyloris Pharmaceuticals (는) 각각 연간 98% 및 73.6% 수익과 수익이 증가할 것으로 예상됩니다. EPS는 연간 98% 만큼 성장할 것으로 예상됩니다. 자기자본이익률은 3년 후 60.5% 로 예상됩니다.핵심 정보98.0%이익 성장률97.96%EPS 성장률Pharmaceuticals 이익 성장24.5%매출 성장률73.6%향후 자기자본이익률60.53%애널리스트 커버리지Low마지막 업데이트15 Jul 2026최근 향후 성장 업데이트Breakeven Date Change • Sep 16No longer forecast to breakevenThe 2 analysts covering Hyloris Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €1.20m in 2026. New consensus forecast suggests the company will make a loss of €16.2m in 2026.Breakeven Date Change • Oct 25Forecast breakeven date moved forward to 2024The 2 analysts covering Hyloris Pharmaceuticals previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 13% to 2023. The company is expected to make a profit of €1.05m in 2024. Average annual earnings growth of 116% is required to achieve expected profit on schedule.Breakeven Date Change • Jul 26Forecast breakeven date pushed back to 2025The analyst covering Hyloris Pharmaceuticals previously expected the company to break even in 2024. New forecast suggests losses will reduce by 9.6% per year to 2024. The company is expected to make a profit of €8.00m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule.Breakeven Date Change • May 04Forecast to breakeven in 2024The 2 analysts covering Hyloris Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €7.00m in 2024. Average annual earnings growth of 72% is required to achieve expected profit on schedule.모든 업데이트 보기Recent updates공고 • Jul 23Hyloris Pharmaceuticals SA to Report Fiscal Year 2026 Results on Apr 30, 2027Hyloris Pharmaceuticals SA announced that they will report fiscal year 2026 results on Apr 30, 2027Board Change • May 20Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Melanie Mestdagt was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.공고 • May 11Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time.공고 • Apr 23Hyloris Pharmaceuticals SA to Report Fiscal Year 2026 Results on Mar 25, 2027Hyloris Pharmaceuticals SA announced that they will report fiscal year 2026 results on Mar 25, 2027New Risk • Jan 03New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-€7.4m free cash flow). Minor Risk Share price has been volatile over the past 3 months (7.9% average weekly change).Board Change • Dec 30Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Melanie Mestdagt was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.공고 • Sep 25+ 1 more updateHyloris Pharmaceuticals SA to Report Fiscal Year 2025 Final Results on Apr 30, 2026Hyloris Pharmaceuticals SA announced that they will report fiscal year 2025 final results on Apr 30, 2026공고 • May 13Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 10, 2025Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 10, 2025, at 14:00 Romance Standard Time.Board Change • Dec 30Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Vincent Dessel was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Reported Earnings • Oct 22First half 2024 earnings released: €0.12 loss per share (vs €0.20 loss in 1H 2023)First half 2024 results: €0.12 loss per share (improved from €0.20 loss in 1H 2023). Revenue: €4.64m (up 143% from 1H 2023). Net loss: €3.49m (loss narrowed 38% from 1H 2023). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany.공고 • Oct 07Hyloris Pharmaceuticals SA to Report Fiscal Year 2024 Results on Mar 20, 2025Hyloris Pharmaceuticals SA announced that they will report fiscal year 2024 results on Mar 20, 2025공고 • Oct 05Hyloris Pharmaceuticals SA to Report Fiscal Year 2024 Final Results on Apr 30, 2025Hyloris Pharmaceuticals SA announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Apr 30, 2025Breakeven Date Change • Sep 16No longer forecast to breakevenThe 2 analysts covering Hyloris Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €1.20m in 2026. New consensus forecast suggests the company will make a loss of €16.2m in 2026.New Risk • Sep 16New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 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 Risk Shares are highly illiquid. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Revenue is less than US$5m (€4.2m revenue, or US$4.7m).Board Change • Aug 21Less 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. 8 experienced directors. No highly experienced directors. 3 independent directors (5 non-independent directors). Independent Director Chris Buyse was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.공고 • Mar 21Hyloris Pharmaceuticals SA to Report First Half, 2024 Results on Sep 05, 2024Hyloris Pharmaceuticals SA announced that they will report first half, 2024 results on Sep 05, 2024Reported Earnings • Mar 14Full year 2023 earnings releasedFull year 2023 results: Net loss: €15.8m (loss widened 46% from FY 2022). Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany.공고 • Feb 15Hyloris Pharmaceuticals SA Enrolls First Patient in Phase 3 Clinical Trial for Its Proprietary Mouth Rinse to Control Incidences of Bleeding Related to Dental ProceduresHyloris Pharmaceuticals SA announced that the first patient has been enrolled in a pivotal Phase 3 clinical trial for Tranexamic Acid Oral Rinse. Hyloris' product candidate is a new treatment for use in patients on anti-coagulant therapies (blood thinners) undergoing dental procedures with a risk of excessive bleeding. It is an oral solution containing the locally-acting antifibrinolytic agent tranexamic acid. Positive data in a Phase 1 pharmacokinetic (PK) trial in healthy subjects suggested the treatment was well tolerated under varied conditions with no serious adverse events following tooth extraction, while effectively controlling procedural bleeding without delaying clot formation. Hyloris' proprietary reformulated oral rinse was developed for use in minor surgical procedures with complications/bleedings. The formulation can be used by dental care professionals for patients on anti-coagULant therapies who benefit from the opportunity to continue their anti-coagulant treatments when scheduled for dental procedures. By addressing the unique challenges faced by individuals on blood thinners, this oral care solution seeks to enhance the overall dental experience and improve the oral health of these patients. Tranexamic acid is an antifibrinolytic agents that has been used for decades to reduce or prevent postoperative bleeding in patients with bleeding problems. The drug is currently approved for intravenous administration (CYKLOKAPRON®? IV) in the U.S. for reduction or prevention of bleeding in patients having a high risk of intra and post-operative haemorrhage (during general and oral surgery, such as tooth extractions) due to a bleeding disorder such as haemophilia (as indicated). The drug is also approved in the U.S. as an oral tablet (LYSTEDA®?) for cyclic heavy menstrual bleeding.공고 • Jan 30Hyloris Pharmaceuticals SA Announces Positive Results for the Phase 2 Trial of Miconazole Domiphen-Bromide (MCZ-DB) in Patients with Acute Vulvovaginal CandidiasisHyloris Pharmaceuticals SA announced positive results for the phase 2 trial of Miconazole Domiphen-Bromide (MCZ-DB) in patients with acute vulvovaginal candidiasis. The phase 2 trial of MCZ-DB was a 12-week, randomized, double-blind, active-controlled, dose finding trial evaluating the safety and efficacy of two doses of MCZ-DB (MCZ 2% combined with 0.14% or 0.29% of DB) administered once per day for 7 days in patients with acute vulvovaginal candidiasis. The study has been conducted in Belgium with a total of 102 patients enrolled. Efficacy was evaluated by assessing the clinical outcome and mycological outcome to the treatment. A positive clinical outcome is a resolution of VVC signs and symptoms whereas the mycological outcome is determined by a vaginal swab indicating the absence of Candida species yeast. Top line results are summarized: At day 29, day 57 and day 85, the low dose (MCZ and 0.14% of DB) demonstrated superior efficacy compared to the active control (MCZ). At day 15, both doses administered demonstrated positive safety and tolerability without significant superiority over the active control. MCZ-DB was well tolerated in both dose cohorts, with no reported serious adverse events. Following the treatments, there was no indication of systemic exposure to Domiphen Bromide.Breakeven Date Change • Oct 25Forecast breakeven date moved forward to 2024The 2 analysts covering Hyloris Pharmaceuticals previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 13% to 2023. The company is expected to make a profit of €1.05m in 2024. Average annual earnings growth of 116% is required to achieve expected profit on schedule.공고 • Oct 18Hyloris Pharmaceuticals SA Announces U.S. FDA Approval of Maxigesic® IVHyloris Pharmaceuticals SA announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary. The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates. An exclusive license and distribution agreement for the U.S., was already signed between Hyloris’ partner AFT Pharmaceuticals (“AFT”) and Hikma Pharmaceuticals (“Hikma”). Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties and milestone payments, received by AFT. Distribution of Maxigesic® IV in U.S. hospitals should start in early 2024. Following first U.S. sales, Hyloris will be entitled to a milestone payment of USD 2,1 million. In addition, the payment of USD 1,5 million (approximately EUR 1,4 million) relating to existing trade receivables is expected. development of chronic opioid use after surgery is one of the most common post-operative complications2 with particularly devastating consequences. In the U.S., prevalence of new chronic opioid use after surgical procedures was estimated close to 6%3. In the past 2 decades, prescription opioid usage in the U.S. contributed to over 600,000 deaths related to opioid overdoses, with the annual death toll rising tenfold between 1999 and 2021 (80,000 deaths in 2021). Nearly 17,000 deaths involved prescription opioids in 20214.Patients requiring medical attention related to opioid abuse account for around $11 billion of added costs to the U.S. healthcare system annually, or 1% of all hospital costs5.공고 • Sep 07+ 2 more updatesHyloris Pharmaceuticals SA, Annual General Meeting, Jun 04, 2024Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 04, 2024.Breakeven Date Change • Jul 26Forecast breakeven date pushed back to 2025The analyst covering Hyloris Pharmaceuticals previously expected the company to break even in 2024. New forecast suggests losses will reduce by 9.6% per year to 2024. The company is expected to make a profit of €8.00m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule.Reported Earnings • Mar 17Full year 2022 earnings releasedFull year 2022 results: Net loss: €10.8m (loss narrowed 7.0% from FY 2021). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany.공고 • Jan 20Hyloris Pharmaceuticals SA Expands Its Pipeline with A Product Candidate for A Mineral Deficiency in the Blood (Hypophosphatemia)Hyloris Pharmaceuticals SA announced it has in-licensed a product candidate targeting hypophosphatemia. This serious condition causes patients to have a low level of phosphorous in the blood. While mild hypophosphatemia is common and many patients are asymptomatic, severe hypophosphatemia can be life-threatening and requires medical treatment. The condition can result in different health challenges, including muscle and bone weakness, respiratory or heart failure, seizures or coma. Deficiency of this vital mineral is always linked to an underlying condition, such as diabetes, anorexia, use of diuretics or alcohol abuse. About Hypophosphatemia: Treatment protocols for patients deficient in phosphate are well-established and have proven useful in other situations of bone mineral imbalance. Oral administration is the preferred way of treating hypophosphatemia, although in most countries no approved drugs exist. Currently, physicians mostly rely on compounded drugs which have, by definition, not been submitted for regulatory scrutiny regarding safety, efficacy, and quality. The company will seek advice and approval from regulators by making use of the rich body of clinical data that has emerged from established clinical practice. With a primary on safety of the product, the company intends to conduct a streamlined development program to achieve market access in Europe, targeting regulatory approval in European countries as from 2026. Global rights of the ongoing development have been licensed-in from Dutch company, QliniQ, who maintains the rights to commercialize the product candidate in its home country, and a selected number of Middle Eastern and developing countries.공고 • Sep 16+ 1 more updateHyloris Pharmaceuticals SA to Report Fiscal Year 2022 Results on Apr 28, 2023Hyloris Pharmaceuticals SA announced that they will report fiscal year 2022 results on Apr 28, 2023공고 • Sep 01Hyloris Pharmaceuticals SA to Report Fiscal Year 2022 Results on Mar 16, 2023Hyloris Pharmaceuticals SA announced that they will report fiscal year 2022 results on Mar 16, 2023Breakeven Date Change • May 04Forecast to breakeven in 2024The 2 analysts covering Hyloris Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €7.00m in 2024. Average annual earnings growth of 72% is required to achieve expected profit on schedule.이익 및 매출 성장 예측DB:52U - 애널리스트 향후 추정치 및 과거 재무 데이터 (EUR Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/202812856N/A115312/31/20275720N/A49312/31/202622-3N/A1312/31/20258-6-8-7N/A9/30/20258-6-8-7N/A6/30/20258-6-7-7N/A3/31/20259-6-7-7N/A12/31/202410-6-7-7N/A9/30/20248-10-10-10N/A6/30/20246-13-13-12N/A3/31/20245-14-13-12N/A12/31/20234-15-14-13N/A9/30/20234-14-13-12N/A6/30/20233-13-12-11N/A3/31/20233-12-13-12N/A12/31/20222-12-14-13N/A9/30/20223-10-12-11N/A6/30/20223-8-9-8N/A3/31/20223-10-11-10N/A12/31/20213-12-12-11N/A9/30/20212-12-13-13N/A6/30/20211-12-14-14N/A3/31/20211-10-7-7N/A12/31/20200-7-5-5N/A9/30/20200-8-5-4N/A6/30/20200-8-5-4N/A3/31/20200-6-8-6N/A12/31/20190-5-6-5N/A12/31/20180-6N/A-5N/A12/31/20170-4N/A-2N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: 52U 은 향후 3년 동안 수익을 낼 것으로 예상되며, 이는 절약률(2.1%)보다 빠른 성장으로 간주됩니다.수익 vs 시장: 52U (는) 향후 3년 동안 평균 시장 성장보다 높은 수익을 올릴 것으로 예상됩니다.고성장 수익: 52U 향후 3년 내에 수익을 낼 것으로 예상됩니다.수익 대 시장: 52U 의 수익(연간 73.6%)이 German 시장(연간 6.6%)보다 빠르게 성장할 것으로 예상됩니다.고성장 매출: 52U 의 수익(연간 73.6%)은 연간 20%보다 빠르게 증가할 것으로 예상됩니다.주당순이익 성장 예측향후 자기자본이익률미래 ROE: 52U의 자본 수익률은 3년 후 60.5%로 매우 높을 것으로 예상됩니다.성장 기업 찾아보기7D1Y7D1Y7D1YPharmaceuticals-biotech 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/08/13 23:06종가2026/08/13 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 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.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 소스Hyloris Pharmaceuticals SA는 4명의 분석가가 다루고 있습니다. 이 중 3명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Beatrice AllenBerenbergDavid SeynnaeveDegroof PetercamJacob MekhaelKBC Securities NV1명의 분석가 더 보기
Breakeven Date Change • Sep 16No longer forecast to breakevenThe 2 analysts covering Hyloris Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €1.20m in 2026. New consensus forecast suggests the company will make a loss of €16.2m in 2026.
Breakeven Date Change • Oct 25Forecast breakeven date moved forward to 2024The 2 analysts covering Hyloris Pharmaceuticals previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 13% to 2023. The company is expected to make a profit of €1.05m in 2024. Average annual earnings growth of 116% is required to achieve expected profit on schedule.
Breakeven Date Change • Jul 26Forecast breakeven date pushed back to 2025The analyst covering Hyloris Pharmaceuticals previously expected the company to break even in 2024. New forecast suggests losses will reduce by 9.6% per year to 2024. The company is expected to make a profit of €8.00m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule.
Breakeven Date Change • May 04Forecast to breakeven in 2024The 2 analysts covering Hyloris Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €7.00m in 2024. Average annual earnings growth of 72% is required to achieve expected profit on schedule.
공고 • Jul 23Hyloris Pharmaceuticals SA to Report Fiscal Year 2026 Results on Apr 30, 2027Hyloris Pharmaceuticals SA announced that they will report fiscal year 2026 results on Apr 30, 2027
Board Change • May 20Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Melanie Mestdagt was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
공고 • May 11Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time.
공고 • Apr 23Hyloris Pharmaceuticals SA to Report Fiscal Year 2026 Results on Mar 25, 2027Hyloris Pharmaceuticals SA announced that they will report fiscal year 2026 results on Mar 25, 2027
New Risk • Jan 03New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-€7.4m free cash flow). Minor Risk Share price has been volatile over the past 3 months (7.9% average weekly change).
Board Change • Dec 30Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Melanie Mestdagt was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
공고 • Sep 25+ 1 more updateHyloris Pharmaceuticals SA to Report Fiscal Year 2025 Final Results on Apr 30, 2026Hyloris Pharmaceuticals SA announced that they will report fiscal year 2025 final results on Apr 30, 2026
공고 • May 13Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 10, 2025Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 10, 2025, at 14:00 Romance Standard Time.
Board Change • Dec 30Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Vincent Dessel was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Reported Earnings • Oct 22First half 2024 earnings released: €0.12 loss per share (vs €0.20 loss in 1H 2023)First half 2024 results: €0.12 loss per share (improved from €0.20 loss in 1H 2023). Revenue: €4.64m (up 143% from 1H 2023). Net loss: €3.49m (loss narrowed 38% from 1H 2023). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany.
공고 • Oct 07Hyloris Pharmaceuticals SA to Report Fiscal Year 2024 Results on Mar 20, 2025Hyloris Pharmaceuticals SA announced that they will report fiscal year 2024 results on Mar 20, 2025
공고 • Oct 05Hyloris Pharmaceuticals SA to Report Fiscal Year 2024 Final Results on Apr 30, 2025Hyloris Pharmaceuticals SA announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Apr 30, 2025
Breakeven Date Change • Sep 16No longer forecast to breakevenThe 2 analysts covering Hyloris Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €1.20m in 2026. New consensus forecast suggests the company will make a loss of €16.2m in 2026.
New Risk • Sep 16New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 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 Risk Shares are highly illiquid. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Revenue is less than US$5m (€4.2m revenue, or US$4.7m).
Board Change • Aug 21Less 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. 8 experienced directors. No highly experienced directors. 3 independent directors (5 non-independent directors). Independent Director Chris Buyse was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
공고 • Mar 21Hyloris Pharmaceuticals SA to Report First Half, 2024 Results on Sep 05, 2024Hyloris Pharmaceuticals SA announced that they will report first half, 2024 results on Sep 05, 2024
Reported Earnings • Mar 14Full year 2023 earnings releasedFull year 2023 results: Net loss: €15.8m (loss widened 46% from FY 2022). Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany.
공고 • Feb 15Hyloris Pharmaceuticals SA Enrolls First Patient in Phase 3 Clinical Trial for Its Proprietary Mouth Rinse to Control Incidences of Bleeding Related to Dental ProceduresHyloris Pharmaceuticals SA announced that the first patient has been enrolled in a pivotal Phase 3 clinical trial for Tranexamic Acid Oral Rinse. Hyloris' product candidate is a new treatment for use in patients on anti-coagulant therapies (blood thinners) undergoing dental procedures with a risk of excessive bleeding. It is an oral solution containing the locally-acting antifibrinolytic agent tranexamic acid. Positive data in a Phase 1 pharmacokinetic (PK) trial in healthy subjects suggested the treatment was well tolerated under varied conditions with no serious adverse events following tooth extraction, while effectively controlling procedural bleeding without delaying clot formation. Hyloris' proprietary reformulated oral rinse was developed for use in minor surgical procedures with complications/bleedings. The formulation can be used by dental care professionals for patients on anti-coagULant therapies who benefit from the opportunity to continue their anti-coagulant treatments when scheduled for dental procedures. By addressing the unique challenges faced by individuals on blood thinners, this oral care solution seeks to enhance the overall dental experience and improve the oral health of these patients. Tranexamic acid is an antifibrinolytic agents that has been used for decades to reduce or prevent postoperative bleeding in patients with bleeding problems. The drug is currently approved for intravenous administration (CYKLOKAPRON®? IV) in the U.S. for reduction or prevention of bleeding in patients having a high risk of intra and post-operative haemorrhage (during general and oral surgery, such as tooth extractions) due to a bleeding disorder such as haemophilia (as indicated). The drug is also approved in the U.S. as an oral tablet (LYSTEDA®?) for cyclic heavy menstrual bleeding.
공고 • Jan 30Hyloris Pharmaceuticals SA Announces Positive Results for the Phase 2 Trial of Miconazole Domiphen-Bromide (MCZ-DB) in Patients with Acute Vulvovaginal CandidiasisHyloris Pharmaceuticals SA announced positive results for the phase 2 trial of Miconazole Domiphen-Bromide (MCZ-DB) in patients with acute vulvovaginal candidiasis. The phase 2 trial of MCZ-DB was a 12-week, randomized, double-blind, active-controlled, dose finding trial evaluating the safety and efficacy of two doses of MCZ-DB (MCZ 2% combined with 0.14% or 0.29% of DB) administered once per day for 7 days in patients with acute vulvovaginal candidiasis. The study has been conducted in Belgium with a total of 102 patients enrolled. Efficacy was evaluated by assessing the clinical outcome and mycological outcome to the treatment. A positive clinical outcome is a resolution of VVC signs and symptoms whereas the mycological outcome is determined by a vaginal swab indicating the absence of Candida species yeast. Top line results are summarized: At day 29, day 57 and day 85, the low dose (MCZ and 0.14% of DB) demonstrated superior efficacy compared to the active control (MCZ). At day 15, both doses administered demonstrated positive safety and tolerability without significant superiority over the active control. MCZ-DB was well tolerated in both dose cohorts, with no reported serious adverse events. Following the treatments, there was no indication of systemic exposure to Domiphen Bromide.
Breakeven Date Change • Oct 25Forecast breakeven date moved forward to 2024The 2 analysts covering Hyloris Pharmaceuticals previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 13% to 2023. The company is expected to make a profit of €1.05m in 2024. Average annual earnings growth of 116% is required to achieve expected profit on schedule.
공고 • Oct 18Hyloris Pharmaceuticals SA Announces U.S. FDA Approval of Maxigesic® IVHyloris Pharmaceuticals SA announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary. The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates. An exclusive license and distribution agreement for the U.S., was already signed between Hyloris’ partner AFT Pharmaceuticals (“AFT”) and Hikma Pharmaceuticals (“Hikma”). Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties and milestone payments, received by AFT. Distribution of Maxigesic® IV in U.S. hospitals should start in early 2024. Following first U.S. sales, Hyloris will be entitled to a milestone payment of USD 2,1 million. In addition, the payment of USD 1,5 million (approximately EUR 1,4 million) relating to existing trade receivables is expected. development of chronic opioid use after surgery is one of the most common post-operative complications2 with particularly devastating consequences. In the U.S., prevalence of new chronic opioid use after surgical procedures was estimated close to 6%3. In the past 2 decades, prescription opioid usage in the U.S. contributed to over 600,000 deaths related to opioid overdoses, with the annual death toll rising tenfold between 1999 and 2021 (80,000 deaths in 2021). Nearly 17,000 deaths involved prescription opioids in 20214.Patients requiring medical attention related to opioid abuse account for around $11 billion of added costs to the U.S. healthcare system annually, or 1% of all hospital costs5.
공고 • Sep 07+ 2 more updatesHyloris Pharmaceuticals SA, Annual General Meeting, Jun 04, 2024Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 04, 2024.
Breakeven Date Change • Jul 26Forecast breakeven date pushed back to 2025The analyst covering Hyloris Pharmaceuticals previously expected the company to break even in 2024. New forecast suggests losses will reduce by 9.6% per year to 2024. The company is expected to make a profit of €8.00m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule.
Reported Earnings • Mar 17Full year 2022 earnings releasedFull year 2022 results: Net loss: €10.8m (loss narrowed 7.0% from FY 2021). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany.
공고 • Jan 20Hyloris Pharmaceuticals SA Expands Its Pipeline with A Product Candidate for A Mineral Deficiency in the Blood (Hypophosphatemia)Hyloris Pharmaceuticals SA announced it has in-licensed a product candidate targeting hypophosphatemia. This serious condition causes patients to have a low level of phosphorous in the blood. While mild hypophosphatemia is common and many patients are asymptomatic, severe hypophosphatemia can be life-threatening and requires medical treatment. The condition can result in different health challenges, including muscle and bone weakness, respiratory or heart failure, seizures or coma. Deficiency of this vital mineral is always linked to an underlying condition, such as diabetes, anorexia, use of diuretics or alcohol abuse. About Hypophosphatemia: Treatment protocols for patients deficient in phosphate are well-established and have proven useful in other situations of bone mineral imbalance. Oral administration is the preferred way of treating hypophosphatemia, although in most countries no approved drugs exist. Currently, physicians mostly rely on compounded drugs which have, by definition, not been submitted for regulatory scrutiny regarding safety, efficacy, and quality. The company will seek advice and approval from regulators by making use of the rich body of clinical data that has emerged from established clinical practice. With a primary on safety of the product, the company intends to conduct a streamlined development program to achieve market access in Europe, targeting regulatory approval in European countries as from 2026. Global rights of the ongoing development have been licensed-in from Dutch company, QliniQ, who maintains the rights to commercialize the product candidate in its home country, and a selected number of Middle Eastern and developing countries.
공고 • Sep 16+ 1 more updateHyloris Pharmaceuticals SA to Report Fiscal Year 2022 Results on Apr 28, 2023Hyloris Pharmaceuticals SA announced that they will report fiscal year 2022 results on Apr 28, 2023
공고 • Sep 01Hyloris Pharmaceuticals SA to Report Fiscal Year 2022 Results on Mar 16, 2023Hyloris Pharmaceuticals SA announced that they will report fiscal year 2022 results on Mar 16, 2023
Breakeven Date Change • May 04Forecast to breakeven in 2024The 2 analysts covering Hyloris Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €7.00m in 2024. Average annual earnings growth of 72% is required to achieve expected profit on schedule.