This company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsFormycon (FYBD) 주식 개요A biotechnology company, develops biosimilar drugs in Germany and Switzerland. 자세히 보기FYBD 펀더멘털 분석스노우플레이크 점수가치 평가4/6미래 성장5/6과거 실적0/6재무 건전성5/6배당0/6강점공정 가치 추정치보다 낮은 88.7% 에서 거래수익은 매년 80.76% 증가할 것으로 예상됩니다.위험 분석주식은 유동성이 매우 낮습니다지난 1년 동안 주주가 희석되었습니다.모든 위험 점검 보기FYBD Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€63.30405.6% 고평가 내재 할인율Growth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-42m198m2016201920222025202620282031Revenue €197.9mEarnings €36.9mAdvancedSet Fair ValueView all narrativesFormycon AG 경쟁사Oxford BiomedicaSymbol: LSE:OXBMarket cap: UK£757.0mGenusSymbol: LSE:GNSMarket cap: UK£1.6bScancell HoldingsSymbol: AIM:SCLPMarket cap: UK£238.7mBioventixSymbol: AIM:BVXPMarket cap: UK£88.8m가격 이력 및 성과Formycon 주가의 최고가, 최저가 및 변동 요약과거 주가현재 주가€63.3052주 최고가€76.3052주 최저가€63.30베타0.921개월 변동0%3개월 변동n/a1년 변동-11.10%3년 변동113.13%5년 변동105.85%IPO 이후 변동97.81%최근 뉴스 및 업데이트공시 • Dec 30+ 3 more updatesFormycon AG to Report Fiscal Year 2025 Results on Mar 26, 2026Formycon AG announced that they will report fiscal year 2025 results on Mar 26, 2026공시 • Jul 11Formycon AG Completes Patient Enrollment for the Clinical Development of Its Keytruda®? Biosimilar Candidate FYB206Formycon AG announced that the patient enrollment for the clinical PK study Dahlia has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®?2. At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 With the reference drug Keytruda®? based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda®? outside the trial. With streamlined clinical development program for FYB206, have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The first patients in the Dahlia trial have already completed all 17 treatment cycles. therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.공시 • Jun 20Formycon Ag Elects Graham Keith Dixon as A New Member of the Supervisory BoardFormycon AG announced that Graham Keith Dixon elected as a new member of the Supervisory Board.공시 • May 13Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. The company expects Revenue to be €55.0 million to €65.0 million.공시 • May 09Formycon AG, Annual General Meeting, Jun 18, 2025Formycon AG, Annual General Meeting, Jun 18, 2025, at 11:00 W. Europe Standard Time.공시 • Mar 28Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. For the year, the company expected revenue to be EUR 55.0 million to EUR 65.0 million.더 많은 업데이트 보기Recent updates공시 • Dec 30+ 3 more updatesFormycon AG to Report Fiscal Year 2025 Results on Mar 26, 2026Formycon AG announced that they will report fiscal year 2025 results on Mar 26, 2026공시 • Jul 11Formycon AG Completes Patient Enrollment for the Clinical Development of Its Keytruda®? Biosimilar Candidate FYB206Formycon AG announced that the patient enrollment for the clinical PK study Dahlia has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®?2. At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 With the reference drug Keytruda®? based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda®? outside the trial. With streamlined clinical development program for FYB206, have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The first patients in the Dahlia trial have already completed all 17 treatment cycles. therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.공시 • Jun 20Formycon Ag Elects Graham Keith Dixon as A New Member of the Supervisory BoardFormycon AG announced that Graham Keith Dixon elected as a new member of the Supervisory Board.공시 • May 13Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. The company expects Revenue to be €55.0 million to €65.0 million.공시 • May 09Formycon AG, Annual General Meeting, Jun 18, 2025Formycon AG, Annual General Meeting, Jun 18, 2025, at 11:00 W. Europe Standard Time.공시 • Mar 28Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. For the year, the company expected revenue to be EUR 55.0 million to EUR 65.0 million.공시 • Mar 04Fresenius Kabi Continues Growth of Biosimilars Portfolio with the U.S. Availability of Otulfi®? (Ustekinumab-Aauz)Fresenius Kabi and Formycon AG announced that the ustekinumab biosimilarOtulfi®? (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. The development and commercialization of the ustekinumib biosimilar is the first biosimilar product launched in the U.S. from the partnership between Fresenius and Formycon AG. The drug received FDA approval in September 2024. Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA approval in the first half of 2025. The FDA approval of Otulfi (ustekinumab -aauz) was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with Otulfi in the U.S. Otulfi (ustek in the U.S. is the fourth Fresenius biosimilar commercialized in the U.S., following the approvals and launches of Idacio®? (adalimumab-aacf), Tyenne®? (tocilizumab-aazg) and Stimufend®? (pegfilgrastim-fpgk). Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections; Malignancies were reported among subjects who received ustekinumab in clinical trials. Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status - notably as the only corporation offering both product groups. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders - shaping the future of health care. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; Future results could differ materially from those described in the U.S.공시 • Feb 17Formycon AG Announces Decision on Phase III Trial with FYB206 and Provides Update on Potential Need to Adjust the Valuation of FYB202 and FYB201Formycon AG has decided to prematurely terminate the Phase III trial (‘Lotus’) for its biosimilar candidate Fiscal Year B206. Based on an intensive scientific dialogue with the U.S. Food and Drug Administration (FDA), the Executive Board, after careful consideration, has concluded that the continuation of the study is no longer necessary for the development and approval of Fiscal Year B206 in the U.S. The therapeutic comparability of Fiscal Year B206 with the reference drug Keytruda3 can be sufficiently demonstrated using data from the ongoing parallel study in the melanoma indication (‘Dahlia’), combined with a comprehensive analytical program. According to preliminary estimates, discontinuing the Phase III trial could lead to investment savings in the high double-digit million range over the next few years, positively impacting the Company’s cash flow statement and liquidity. In coordination with commercialization partner Fresenius Kabi AG, as part of the imminent market launch of Fiscal Year B202/Otulfi in the U.S., Formycon anticipates that the valuation model and balance sheet measurement for Fiscal Year B202 will need to be reviewed and adjusted due to an emerging, significantly higher-than-expected price discount for biosimilars. Based on preliminary calculations, Formycon currently expects a non-cash impairment requirement in the high double-digit to low triple-digit million range. Due to the increasing price discounts among ranibizumab providers in the U.S., Bioeq AG, the exclusive license holder of Fiscal Year B201/CIMERLI, is currently in discussions with its commercialization partner Sandoz AG regarding the future commercialization strategy for Fiscal Year B201/CIMERLI in the U.S. Based on the status of these discussions, Formycon currently expects that the commercialization of Fiscal Year B201/CIMERLI will likely be temporarily paused. This would result in an extraordinary adjustment to the valuation model and the balance sheet measurement for Fiscal Year B201, as well as the stake in Bioeq AG, amounting to a high single-digit to low double-digit non-cash million figure for the 2024 financial year. In this context, Bioeq AG is exploring alternative commercialization strategies for the U.S. Formycon will provide updates on further developments in due course.공시 • Jan 21Formycon Receives EU Approval for FYB203 (Aflibercept), A Biosimilar to Eylea, Under the Brand Names Ahzantive and BaiamaFormycon AG received EU approval for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE and Baiama and Baiama. In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was already approved by the U.S. Food and Drug Administration (FDA) in June 2024. Eylea is a registered trademark of Regeneron Pharmaceuticals Inc. AHZANTIVE is a registered trademark the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees.공시 • Jan 16Formycon AG and Fresenius Kabi Announce MHRA Approval for FYB202/Otulfi (Ustekinumab), Biosimilar to StelaraFormycon AG and its commercialization partner Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi (ustekinumab), a biosimilar to Stelara, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The U.S. Food and Drug Administration (FDA) as well as the European Commission had already granted marketing authorization for FYB202 in September 2024, followed by Health Canada’s approval end of December 2024. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the UK. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).공시 • Jan 02+ 2 more updatesFormycon AG to Report Q1, 2025 Results on May 15, 2025Formycon AG announced that they will report Q1, 2025 results on May 15, 2025공시 • Nov 15Formycon AG Appoints Colin Bond as DirectorIn accordance with paragraph 6.4.9 R of the UK Listing Rules, BioPharma Credit PLC, has been informed that Colin Bond, Non-executive Director of the Company, has been appointed as a director of Formycon AG with effect from 1 October 2024.공시 • Oct 01Fresenius Kabi and Formycon Receives U.S. FDA Approval for Biosimilar Otulfi (ustekinumab-aauz)Fresenius Kabi and Formycon AG announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara(ustekinumab). Otulfi is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma platform, which is a substantial cornerstone of #FutureFresenius. In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The FDA approval of Otulfi (ustekinumab-aauz) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). Otulfi was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Otulfi™ is contraindicated in patients with significant hypersensitivity to ustekinumab or to any of the excipients. Otulfi (ustekinumab-aauz) is Fresenius Kabi’s fourth biosimilar granted a marketing authorization in the U.S., following previous approvals of its commercially available biosimilars Idacio (adalimumab-aacf), Tyenne (tocilizumab-aazg) and Stimufend (pegfilgrastim-fpgk). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.공시 • Aug 06Formycon AG to Report First Half, 2024 Results on Aug 13, 2024Formycon AG announced that they will report first half, 2024 results on Aug 13, 2024공시 • May 03Formycon AG to Report Q1, 2024 Results on May 08, 2024Formycon AG announced that they will report Q1, 2024 results on May 08, 2024공시 • Apr 13Formycon AG to Report Fiscal Year 2023 Final Results on Apr 25, 2024Formycon AG announced that they will report fiscal year 2023 final results on Apr 25, 2024공시 • Aug 24Formycon AG to Report First Half, 2023 Results on Aug 30, 2023Formycon AG announced that they will report first half, 2023 results on Aug 30, 2023공시 • Jun 29Formycon Announces Submission of the Biologics License Application (Bla) for Fyb203, an Aflibercept Biosimilar Candidate to the U.S. Food and Drug Administration (Fda)Formycon AG nd its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule. Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA (“file acceptance”). Eylea® is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. With global sales of around USD 9.6 billion[i] Eylea® is currently the top-selling drug in this therapeutic area.Reported Earnings • Apr 29Full year 2022 earnings released: EPS: €2.62 (vs €1.22 loss in FY 2021)Full year 2022 results: EPS: €2.62 (up from €1.22 loss in FY 2021). Revenue: €42.5m (up 15% from FY 2021). Net income: €36.0m (up €49.5m from FY 2021). Profit margin: 85% (up from net loss in FY 2021). The move to profitability was primarily driven by lower expenses. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has increased by 93% per year but the company’s share price has only increased by 43% per year, which means it is significantly lagging earnings growth.공시 • Feb 03Formycon AG has completed a Follow-on Equity Offering in the amount of €70.07 million.Formycon AG has completed a Follow-on Equity Offering in the amount of €70.07 million. Security Name: Shares Security Type: Common Stock Securities Offered: 910,000 Price\Range: €77 Transaction Features: Rule 144A; Subsequent Direct ListingBreakeven Date Change • May 24Forecast breakeven date pushed back to 2023The 3 analysts covering Formycon previously expected the company to break even in 2022. New consensus forecast suggests the company will make a profit of €16.6m in 2023. Average annual earnings growth of 66% is required to achieve expected profit on schedule.Is New 90 Day High Low • Dec 10New 90-day high: €47.00The company is up 74% from its price of €27.00 on 10 September 2020. The British market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €216 per share.주주 수익률FYBDGB BiotechsGB 시장7D0%3.5%1.8%1Y-11.1%24.7%19.0%전체 주주 수익률 보기수익률 대 산업: FYBD은 지난 1년 동안 24.7%의 수익을 기록한 UK Biotechs 산업보다 더 좋은 성과를 냈습니다.수익률 대 시장: FYBD은 지난 1년 동안 19%를 기록한 UK 시장보다 저조한 성과를 냈습니다.주가 변동성Is FYBD's price volatile compared to industry and market?FYBD volatilityFYBD Average Weekly Movementn/aBiotechs Industry Average Movement9.3%Market Average Movement5.8%10% most volatile stocks in GB Market12.1%10% least volatile stocks in GB Market3.1%안정적인 주가: FYBD는 지난 3개월 동안 UK 시장에 비해 주가 변동성이 크지 않았습니다.시간에 따른 변동성: Insufficient data to determine FYBD의 변동성 변화를 판단할 수 없습니다.회사 소개설립직원 수CEO웹사이트1999224Stefan Glombitzawww.formycon.com더 보기Formycon AG 기초 지표 요약Formycon의 순이익과 매출은 시가총액과 어떻게 비교됩니까?FYBD 기초 통계시가총액€911.00m순이익 (TTM)-€42.23m매출 (TTM)€68.64m13.3x주가매출비율(P/S)-21.6x주가수익비율(P/E)FYBD는 고평가되어 있습니까?공정 가치 및 평가 분석 보기순이익 및 매출최근 실적 보고서(TTM)의 주요 수익성 지표FYBD 손익계산서 (TTM)매출€68.64m매출원가€44.26m총이익€24.38m기타 비용€66.62m순이익-€42.23m최근 보고된 실적Jun 30, 2023다음 실적 발표일해당 없음주당순이익(EPS)-2.63총이익률35.52%순이익률-61.53%부채/자본 비율0%FYBD의 장기 실적은 어땠습니까?과거 실적 및 비교 보기View Valuation기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2023/09/27 04:40종가2023/06/30 00:00수익2023/06/30연간 수익2022/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Formycon AG는 12명의 분석가가 다루고 있습니다. 이 중 5명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Gerhard OrgonasBerenbergBenjamin ThielmannBerenbergSimon ScholesFirst Berlin Equity Research GmbH9명의 분석가 더 보기
공시 • Dec 30+ 3 more updatesFormycon AG to Report Fiscal Year 2025 Results on Mar 26, 2026Formycon AG announced that they will report fiscal year 2025 results on Mar 26, 2026
공시 • Jul 11Formycon AG Completes Patient Enrollment for the Clinical Development of Its Keytruda®? Biosimilar Candidate FYB206Formycon AG announced that the patient enrollment for the clinical PK study Dahlia has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®?2. At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 With the reference drug Keytruda®? based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda®? outside the trial. With streamlined clinical development program for FYB206, have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The first patients in the Dahlia trial have already completed all 17 treatment cycles. therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.
공시 • Jun 20Formycon Ag Elects Graham Keith Dixon as A New Member of the Supervisory BoardFormycon AG announced that Graham Keith Dixon elected as a new member of the Supervisory Board.
공시 • May 13Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. The company expects Revenue to be €55.0 million to €65.0 million.
공시 • May 09Formycon AG, Annual General Meeting, Jun 18, 2025Formycon AG, Annual General Meeting, Jun 18, 2025, at 11:00 W. Europe Standard Time.
공시 • Mar 28Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. For the year, the company expected revenue to be EUR 55.0 million to EUR 65.0 million.
공시 • Dec 30+ 3 more updatesFormycon AG to Report Fiscal Year 2025 Results on Mar 26, 2026Formycon AG announced that they will report fiscal year 2025 results on Mar 26, 2026
공시 • Jul 11Formycon AG Completes Patient Enrollment for the Clinical Development of Its Keytruda®? Biosimilar Candidate FYB206Formycon AG announced that the patient enrollment for the clinical PK study Dahlia has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®?2. At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 With the reference drug Keytruda®? based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda®? outside the trial. With streamlined clinical development program for FYB206, have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The first patients in the Dahlia trial have already completed all 17 treatment cycles. therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.
공시 • Jun 20Formycon Ag Elects Graham Keith Dixon as A New Member of the Supervisory BoardFormycon AG announced that Graham Keith Dixon elected as a new member of the Supervisory Board.
공시 • May 13Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. The company expects Revenue to be €55.0 million to €65.0 million.
공시 • May 09Formycon AG, Annual General Meeting, Jun 18, 2025Formycon AG, Annual General Meeting, Jun 18, 2025, at 11:00 W. Europe Standard Time.
공시 • Mar 28Formycon AG Provides Earnings Guidance for the Year 2025Formycon AG provided earnings guidance for the year 2025. For the year, the company expected revenue to be EUR 55.0 million to EUR 65.0 million.
공시 • Mar 04Fresenius Kabi Continues Growth of Biosimilars Portfolio with the U.S. Availability of Otulfi®? (Ustekinumab-Aauz)Fresenius Kabi and Formycon AG announced that the ustekinumab biosimilarOtulfi®? (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. The development and commercialization of the ustekinumib biosimilar is the first biosimilar product launched in the U.S. from the partnership between Fresenius and Formycon AG. The drug received FDA approval in September 2024. Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA approval in the first half of 2025. The FDA approval of Otulfi (ustekinumab -aauz) was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with Otulfi in the U.S. Otulfi (ustek in the U.S. is the fourth Fresenius biosimilar commercialized in the U.S., following the approvals and launches of Idacio®? (adalimumab-aacf), Tyenne®? (tocilizumab-aazg) and Stimufend®? (pegfilgrastim-fpgk). Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections; Malignancies were reported among subjects who received ustekinumab in clinical trials. Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status - notably as the only corporation offering both product groups. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders - shaping the future of health care. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; Future results could differ materially from those described in the U.S.
공시 • Feb 17Formycon AG Announces Decision on Phase III Trial with FYB206 and Provides Update on Potential Need to Adjust the Valuation of FYB202 and FYB201Formycon AG has decided to prematurely terminate the Phase III trial (‘Lotus’) for its biosimilar candidate Fiscal Year B206. Based on an intensive scientific dialogue with the U.S. Food and Drug Administration (FDA), the Executive Board, after careful consideration, has concluded that the continuation of the study is no longer necessary for the development and approval of Fiscal Year B206 in the U.S. The therapeutic comparability of Fiscal Year B206 with the reference drug Keytruda3 can be sufficiently demonstrated using data from the ongoing parallel study in the melanoma indication (‘Dahlia’), combined with a comprehensive analytical program. According to preliminary estimates, discontinuing the Phase III trial could lead to investment savings in the high double-digit million range over the next few years, positively impacting the Company’s cash flow statement and liquidity. In coordination with commercialization partner Fresenius Kabi AG, as part of the imminent market launch of Fiscal Year B202/Otulfi in the U.S., Formycon anticipates that the valuation model and balance sheet measurement for Fiscal Year B202 will need to be reviewed and adjusted due to an emerging, significantly higher-than-expected price discount for biosimilars. Based on preliminary calculations, Formycon currently expects a non-cash impairment requirement in the high double-digit to low triple-digit million range. Due to the increasing price discounts among ranibizumab providers in the U.S., Bioeq AG, the exclusive license holder of Fiscal Year B201/CIMERLI, is currently in discussions with its commercialization partner Sandoz AG regarding the future commercialization strategy for Fiscal Year B201/CIMERLI in the U.S. Based on the status of these discussions, Formycon currently expects that the commercialization of Fiscal Year B201/CIMERLI will likely be temporarily paused. This would result in an extraordinary adjustment to the valuation model and the balance sheet measurement for Fiscal Year B201, as well as the stake in Bioeq AG, amounting to a high single-digit to low double-digit non-cash million figure for the 2024 financial year. In this context, Bioeq AG is exploring alternative commercialization strategies for the U.S. Formycon will provide updates on further developments in due course.
공시 • Jan 21Formycon Receives EU Approval for FYB203 (Aflibercept), A Biosimilar to Eylea, Under the Brand Names Ahzantive and BaiamaFormycon AG received EU approval for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE and Baiama and Baiama. In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was already approved by the U.S. Food and Drug Administration (FDA) in June 2024. Eylea is a registered trademark of Regeneron Pharmaceuticals Inc. AHZANTIVE is a registered trademark the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees.
공시 • Jan 16Formycon AG and Fresenius Kabi Announce MHRA Approval for FYB202/Otulfi (Ustekinumab), Biosimilar to StelaraFormycon AG and its commercialization partner Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi (ustekinumab), a biosimilar to Stelara, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The U.S. Food and Drug Administration (FDA) as well as the European Commission had already granted marketing authorization for FYB202 in September 2024, followed by Health Canada’s approval end of December 2024. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the UK. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
공시 • Jan 02+ 2 more updatesFormycon AG to Report Q1, 2025 Results on May 15, 2025Formycon AG announced that they will report Q1, 2025 results on May 15, 2025
공시 • Nov 15Formycon AG Appoints Colin Bond as DirectorIn accordance with paragraph 6.4.9 R of the UK Listing Rules, BioPharma Credit PLC, has been informed that Colin Bond, Non-executive Director of the Company, has been appointed as a director of Formycon AG with effect from 1 October 2024.
공시 • Oct 01Fresenius Kabi and Formycon Receives U.S. FDA Approval for Biosimilar Otulfi (ustekinumab-aauz)Fresenius Kabi and Formycon AG announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara(ustekinumab). Otulfi is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma platform, which is a substantial cornerstone of #FutureFresenius. In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The FDA approval of Otulfi (ustekinumab-aauz) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). Otulfi was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Otulfi™ is contraindicated in patients with significant hypersensitivity to ustekinumab or to any of the excipients. Otulfi (ustekinumab-aauz) is Fresenius Kabi’s fourth biosimilar granted a marketing authorization in the U.S., following previous approvals of its commercially available biosimilars Idacio (adalimumab-aacf), Tyenne (tocilizumab-aazg) and Stimufend (pegfilgrastim-fpgk). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.
공시 • Aug 06Formycon AG to Report First Half, 2024 Results on Aug 13, 2024Formycon AG announced that they will report first half, 2024 results on Aug 13, 2024
공시 • May 03Formycon AG to Report Q1, 2024 Results on May 08, 2024Formycon AG announced that they will report Q1, 2024 results on May 08, 2024
공시 • Apr 13Formycon AG to Report Fiscal Year 2023 Final Results on Apr 25, 2024Formycon AG announced that they will report fiscal year 2023 final results on Apr 25, 2024
공시 • Aug 24Formycon AG to Report First Half, 2023 Results on Aug 30, 2023Formycon AG announced that they will report first half, 2023 results on Aug 30, 2023
공시 • Jun 29Formycon Announces Submission of the Biologics License Application (Bla) for Fyb203, an Aflibercept Biosimilar Candidate to the U.S. Food and Drug Administration (Fda)Formycon AG nd its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule. Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA (“file acceptance”). Eylea® is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. With global sales of around USD 9.6 billion[i] Eylea® is currently the top-selling drug in this therapeutic area.
Reported Earnings • Apr 29Full year 2022 earnings released: EPS: €2.62 (vs €1.22 loss in FY 2021)Full year 2022 results: EPS: €2.62 (up from €1.22 loss in FY 2021). Revenue: €42.5m (up 15% from FY 2021). Net income: €36.0m (up €49.5m from FY 2021). Profit margin: 85% (up from net loss in FY 2021). The move to profitability was primarily driven by lower expenses. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has increased by 93% per year but the company’s share price has only increased by 43% per year, which means it is significantly lagging earnings growth.
공시 • Feb 03Formycon AG has completed a Follow-on Equity Offering in the amount of €70.07 million.Formycon AG has completed a Follow-on Equity Offering in the amount of €70.07 million. Security Name: Shares Security Type: Common Stock Securities Offered: 910,000 Price\Range: €77 Transaction Features: Rule 144A; Subsequent Direct Listing
Breakeven Date Change • May 24Forecast breakeven date pushed back to 2023The 3 analysts covering Formycon previously expected the company to break even in 2022. New consensus forecast suggests the company will make a profit of €16.6m in 2023. Average annual earnings growth of 66% is required to achieve expected profit on schedule.
Is New 90 Day High Low • Dec 10New 90-day high: €47.00The company is up 74% from its price of €27.00 on 10 September 2020. The British market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €216 per share.
