Hyloris Pharmaceuticals（52U）株式概要ハイロリス・ファーマシューティカルズSAは、医療ニーズに対応する医薬品の研究、開発、製造に従事している。 詳細52U ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長6/6過去の実績0/6財務の健全性6/6配当金0/6報酬収益は年間98.04%増加すると予測されています 過去5年間の収益は年間5.4%増加しました。 リスク分析リスクチェックの結果、52U 、リスクは検出されなかった。すべてのリスクチェックを見る52U Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW479,394 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINRODA479,394 investors already sharing narrativesYour Fair Value€Current Price€4.3654.1% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-15m125m2016201920222025202620282031Revenue €125.1mEarnings €18.5mAdvancedSet Fair ValueView all narrativesHyloris Pharmaceuticals SA 競合他社Cantourage GroupSymbol: XTRA:HIGHMarket cap: €74.1mMPH Health CareSymbol: DB:93M1Market cap: €101.0mTFF PharmaceuticalsSymbol: MUN:0K30Market cap: €9.7mDermapharm HoldingSymbol: XTRA:DMPMarket cap: €2.0b価格と性能株価の高値、安値、推移の概要Hyloris Pharmaceuticals過去の株価現在の株価€4.3652週高値€8.1452週安値€4.25ベータ0.651ヶ月の変化-4.60%3ヶ月変化-14.17%1年変化-31.45%3年間の変化-62.25%5年間の変化n/aIPOからの変化-72.95%最新ニュースお知らせ • 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.お知らせ • May 11Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time.お知らせ • 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.最新情報をもっと見るRecent updatesお知らせ • 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.お知らせ • May 11Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time.お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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お知らせ • 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.株主還元52UDE PharmaceuticalsDE 市場7D-1.8%-4.6%0.2%1Y-31.4%40.0%3.6%株主還元を見る業界別リターン: 52U過去 1 年間で40 % の収益を上げたGerman Pharmaceuticals業界を下回りました。リターン対市場: 52Uは、過去 1 年間で3.6 % のリターンを上げたGerman市場を下回りました。価格変動Is 52U's price volatile compared to industry and market?52U volatility52U Average Weekly Movement5.6%Pharmaceuticals Industry Average Movement5.4%Market Average Movement5.2%10% most volatile stocks in DE Market13.0%10% least volatile stocks in DE Market2.7%安定した株価: 52U 、 German市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: 52Uの 週次ボラティリティ ( 6% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト201255Stijn Van Rompayhyloris.comHyloris Pharmaceuticals SA社は、医療ニーズに対応する医薬品の研究、開発、製造に従事している。同社は、術後疼痛、オピオイド危機、急性疼痛に使用されるパラセタモールとイブプロフェンの配合剤であるマキシゲシック静注、様々なタイプのヒト乳頭腫ウイルスに起因する外性器および肛門周囲イボの治療に使用される抗真菌剤であるポドフィロックスゲル、心房細動の治療に使用されるソタロール静注を提供している。また、心筋梗塞や脳卒中などの緊急心疾患に伴う罹患率や死亡率のリスクを低減するアスピリン点滴静注用やHY-074点滴静注用、左室デバイスによる右心不全治療薬ミルリノンER、心房細動治療薬ドフェチリド点滴静注用、うっ血性心不全や腎疾患に伴う浮腫などの塩分・水分貯留治療薬メトラゾン点滴静注用、心血管系疾患の予防・治療薬HY-075点滴静注用なども開発している。さらに、歯科治療中の血液希釈剤服用患者の過剰出血を予防・治療するTranexamic Acid Oral Rinse、間質性膀胱炎／膀胱痛症候群に伴う疼痛を治療するAllenura、バイオフィルムを含むカンジダ酵母および／または細菌による膣感染症を治療するMiconazole/Domiphen Bromide cream、急性骨髄性白血病を治療するPTX-252などの付加価値製品も提供している；注意欠陥多動性障害治療薬アトモキセチン経口液、特発性鼻炎治療薬HY-083、低リン血症治療薬HY-088、口内灼熱症候群治療薬HY-090、外陰部苔癬性硬化症治療薬HY-091、馬胃潰瘍治療薬HY-095、胃酸過多、潰瘍およびびらん性食道炎治療薬パントプラゾール静注、悪心・嘔吐治療薬オンダンセトロン、鉄欠乏症治療薬HY-094。FHP社、Pleco Therapeutics社、Vaneltix Pharma社、AFT社と共同研究を行っている。同社は2012年に設立され、ベルギーのリエージュに本社を置いている。もっと見るHyloris Pharmaceuticals SA 基礎のまとめHyloris Pharmaceuticals の収益と売上を時価総額と比較するとどうか。52U 基礎統計学時価総額€125.72m収益（TTM）-€6.33m売上高(TTM)€7.94m15.8xP/Sレシオ-19.8xPER（株価収益率52U は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計52U 損益計算書（TTM）収益€7.94m売上原価€379.00k売上総利益€7.56mその他の費用€13.89m収益-€6.33m直近の収益報告Dec 31, 2025次回決算日Sep 24, 2026一株当たり利益（EPS）-0.23グロス・マージン95.23%純利益率-79.78%有利子負債／自己資本比率0.2%52U の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/08/17 01:39終値2026/08/17 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Hyloris Pharmaceuticals SA 3 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。4 アナリスト機関Beatrice AllenBerenbergDavid SeynnaeveDegroof PetercamJacob MekhaelKBC Securities NV1 その他のアナリストを表示
お知らせ • 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.
お知らせ • May 11Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time.
お知らせ • 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.
お知らせ • 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.
お知らせ • May 11Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026Hyloris Pharmaceuticals SA, Annual General Meeting, Jun 09, 2026, at 14:00 Romance Standard Time.
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
