Formycon（FYB）株式概要フォーミコン社はバイオテクノロジー企業で、ドイツとスイスでバイオシミラー医薬品の開発を行っている。 詳細FYB ファンダメンタル分析スノーフレーク・スコア評価4/6将来の成長5/6過去の実績0/6財務の健全性4/6配当金0/6報酬当社が推定した公正価値より80.4%で取引されている 収益は年間105.86%増加すると予測されています リスク分析リスクチェックの結果、FYB 、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FYB 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€19.6656.1% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-126m212m2016201920222025202620282031Revenue €211.7mEarnings €38.5mAdvancedSet Fair ValueView all narrativesFormycon AG 競合他社Biotest GmbH KGaASymbol: HMSE:BIO0Market cap: €1.5bDextech MedicalSymbol: DB:LQ0Market cap: €184.9mBiotestSymbol: XTRA:BIO3Market cap: €1.4bGenetic AnalysisSymbol: DB:8V8Market cap: €42.7m価格と性能株価の高値、安値、推移の概要Formycon過去の株価現在の株価€19.6652週高値€31.0552週安値€16.52ベータ0.651ヶ月の変化6.39%3ヶ月変化-14.15%1年変化-10.43%3年間の変化-74.20%5年間の変化-68.74%IPOからの変化116.04%最新ニュースお知らせ • May 05Formycon AG, Annual General Meeting, Jun 10, 2026Formycon AG, Annual General Meeting, Jun 10, 2026, at 10:00 W. Europe Standard Time.お知らせ • Apr 16Formycon AG to Report Fiscal Year 2025 Results on Apr 22, 2026Formycon AG announced that they will report fiscal year 2025 results at 9:00 AM, Central European Standard Time on Apr 22, 2026お知らせ • 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, 2026New Risk • Aug 20New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.Reported Earnings • Aug 19First half 2025 earnings released: €3.07 loss per share (vs €0.58 loss in 1H 2024)First half 2025 results: €3.07 loss per share (further deteriorated from €0.58 loss in 1H 2024). Revenue: €9.00m (down 67% from 1H 2024). Net loss: €54.2m (loss widened 437% from 1H 2024). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 61 percentage points per year, which is a significant difference in performance.お知らせ • 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.最新情報をもっと見るRecent updatesお知らせ • May 05Formycon AG, Annual General Meeting, Jun 10, 2026Formycon AG, Annual General Meeting, Jun 10, 2026, at 10:00 W. Europe Standard Time.お知らせ • Apr 16Formycon AG to Report Fiscal Year 2025 Results on Apr 22, 2026Formycon AG announced that they will report fiscal year 2025 results at 9:00 AM, Central European Standard Time on Apr 22, 2026お知らせ • 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, 2026New Risk • Aug 20New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.Reported Earnings • Aug 19First half 2025 earnings released: €3.07 loss per share (vs €0.58 loss in 1H 2024)First half 2025 results: €3.07 loss per share (further deteriorated from €0.58 loss in 1H 2024). Revenue: €9.00m (down 67% from 1H 2024). Net loss: €54.2m (loss widened 437% from 1H 2024). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 61 percentage points per year, which is a significant difference in performance.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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).お知らせ • 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お知らせ • 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.お知らせ • 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.Valuation Update With 7 Day Price Move • Sep 30Investor sentiment improves as stock rises 17%After last week's 17% share price gain to €55.40, the stock trades at a trailing P/E ratio of 14.7x. Average trailing P/E is 26x in the Biotechs industry in Europe. Total returns to shareholders of 8.6% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €75.49 per share.Reported Earnings • Aug 18First half 2024 earnings released: €0.58 loss per share (vs €0.11 profit in 1H 2023)First half 2024 results: €0.58 loss per share (down from €0.11 profit in 1H 2023). Revenue: €26.9m (down 39% from 1H 2023). Net loss: €10.1m (down €11.9m from profit in 1H 2023). Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 42% per year but the company’s share price has remained flat, which means it is significantly lagging earnings.お知らせ • 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, 2024Valuation Update With 7 Day Price Move • Jun 06Investor sentiment improves as stock rises 15%After last week's 15% share price gain to €49.55, the stock trades at a trailing P/E ratio of 11.4x. Average trailing P/E is 26x in the Biotechs industry in Europe. Total loss to shareholders of 19% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €27.46 per share.Price Target Changed • May 12Price target decreased by 8.7% to €87.00Down from €95.25, the current price target is an average from 6 analysts. New target price is 102% above last closing price of €43.05. Stock is down 44% over the past year. The company is forecast to post a net loss per share of €1.05 compared to earnings per share of €4.76 last year.お知らせ • May 03Formycon AG to Report Q1, 2024 Results on May 08, 2024Formycon AG announced that they will report Q1, 2024 results on May 08, 2024Reported Earnings • Apr 25Full year 2023 earnings released: EPS: €4.76 (vs €2.62 in FY 2022)Full year 2023 results: EPS: €4.76 (up from €2.62 in FY 2022). Revenue: €77.7m (up 83% from FY 2022). Net income: €75.8m (up 111% from FY 2022). Profit margin: 98% (up from 85% in FY 2022). The increase in margin was primarily driven by higher revenue. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 16% per year, which means it is significantly lagging earnings.お知らせ • 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, 2024Price Target Changed • Apr 11Price target decreased by 12% to €96.25Down from €109, the current price target is an average from 4 analysts. New target price is 109% above last closing price of €46.00. Stock is down 31% over the past year. The company is forecast to post earnings per share of €3.38 for next year compared to €2.62 last year.New Risk • Apr 01New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 10% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company.Price Target Changed • Jan 30Price target decreased by 8.9% to €105Down from €115, the current price target is an average from 5 analysts. New target price is 110% above last closing price of €50.10. Stock is down 40% over the past year. The company is forecast to post earnings per share of €0.023 for next year compared to €2.62 last year.New Risk • Oct 14New 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 6.1% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (6.1% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding).Price Target Changed • Sep 20Price target decreased by 7.5% to €107Down from €115, the current price target is an average from 5 analysts. New target price is 83% above last closing price of €58.30. Stock is down 19% over the past year. The company is forecast to post a net loss per share of €1.76 compared to earnings per share of €2.62 last year.Reported Earnings • Sep 08First half 2023 earnings released: EPS: €0.11 (vs €6.51 in 1H 2022)First half 2023 results: EPS: €0.11 (down from €6.51 in 1H 2022). Revenue: €43.8m (up 148% from 1H 2022). Net income: €1.80m (down 98% from 1H 2022). Profit margin: 4.1% (down from 454% in 1H 2022). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has only increased by 30% per year, which means it is significantly lagging earnings growth.お知らせ • 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, 2023Price Target Changed • Aug 22Price target decreased by 8.8% to €115Down from €126, the current price target is an average from 3 analysts. New target price is 95% above last closing price of €59.00. Stock is down 30% over the past year. The company is forecast to post a net loss per share of €1.64 compared to earnings per share of €2.62 last year.New Risk • Jul 07New 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 6.7% 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 High level of non-cash earnings (39% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (6.7% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding).お知らせ • 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.Valuation Update With 7 Day Price Move • May 18Investor sentiment improves as stock rises 16%After last week's 16% share price gain to €77.40, the stock trades at a trailing P/E ratio of 34.6x. Average forward P/E is 32x in the Biotechs industry in Europe. Total returns to shareholders of 216% over the past three years.Reported Earnings • Apr 29Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behindFull 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 missed analyst estimates by 1.2%. Earnings per share (EPS) exceeded analyst estimates by 114%. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. 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 44% per year, which means it is significantly lagging earnings growth.お知らせ • 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 ListingPrice Target Changed • Nov 16Price target increased to €126Up from €97.67, the current price target is an average from 3 analysts. New target price is 76% above last closing price of €71.80. Stock is up 45% over the past year. The company is forecast to post earnings per share of €3.19 next year compared to a net loss per share of €1.22 last year.Reported Earnings • Nov 01First half 2022 earnings released: EPS: €6.51 (vs €0.92 loss in 1H 2021)First half 2022 results: EPS: €6.51 (up from €0.92 loss in 1H 2021). Revenue: €17.6m (down 13% from 1H 2021). Net income: €80.0m (up €90.2m from 1H 2021). Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 78% per year but the company’s share price has only increased by 31% per year, which means it is significantly lagging earnings growth.Price Target Changed • Sep 19Price target increased to €107Up from €95.67, the current price target is an average from 3 analysts. New target price is 52% above last closing price of €70.60. Stock is up 37% over the past year. The company is forecast to post earnings per share of €3.05 next year compared to a net loss per share of €1.22 last year.Reported Earnings • May 22Full year 2021 earnings: EPS and revenues miss analyst expectationsFull year 2021 results: €1.22 loss per share (down from €0.54 loss in FY 2020). Revenue: €37.0m (up 8.0% from FY 2020). Net loss: €13.5m (loss widened 127% from FY 2020). Products in clinical trials Phase III: 2 Revenue missed analyst estimates by 9.5%. Earnings per share (EPS) also missed analyst estimates by 2.6%. Over the next year, revenue is forecast to grow 6.6%, compared to a 29% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 132 percentage points per year, which is a significant difference in performance.Price Target Changed • Apr 28Price target increased to €87.00Up from €72.25, the current price target is an average from 4 analysts. New target price is 35% above last closing price of €64.30. Stock is down 3.0% over the past year. The company is forecast to post a net loss per share of €1.49 next year compared to a net loss per share of €0.54 last year.Price Target Changed • Apr 14Price target increased to €75.00Up from €70.00, the current price target is an average from 4 analysts. New target price is 12% above last closing price of €67.10. Stock is up 9.8% over the past year. The company is forecast to post a net loss per share of €1.56 next year compared to a net loss per share of €0.54 last year.Price Target Changed • Sep 29Price target decreased to €70.00Down from €82.00, the current price target is an average from 4 analysts. New target price is 42% above last closing price of €49.15. Stock is up 67% over the past year.Reported Earnings • Sep 24First half 2021 earnings released: €0.92 loss per share (vs €0.14 loss in 1H 2020)The company reported a soft first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: €20.3m (up 23% from 1H 2020). Net loss: €10.2m (loss widened €8.79m from 1H 2020). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 138 percentage points per year, which is a significant difference in performance.Reported Earnings • May 19Full year 2020 earnings releasedThe company reported a soft full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: €34.6m (up 4.5% from FY 2019). Net loss: €5.93m (loss widened 158% from FY 2019).Is New 90 Day High Low • Feb 12New 90-day high: €75.40The company is up 118% from its price of €34.60 on 13 November 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €386 per share.Price Target Changed • Dec 11Price target raised to €46.45Up from €38.45, the current price target is an average from 5 analysts. The new target price is 15% below the current share price of €54.40. As of last close, the stock is up 78% over the past year.Is New 90 Day High Low • Dec 10New 90-day high: €51.00The company is up 88% from its price of €27.10 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €245 per share.お知らせ • Nov 09Formycon AG and Bioeq GmbH Announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R) (Ustekinumab)Formycon AG and Bioeq GmbH announced the dosage of the first patient in the Phase III clinical trial (first-patient-in). The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris. This is the most common form of psoriasis, accounting for 80% to 90% of its occurrence, and is also known as plaque psoriasis. Due to this systemic disease affecting the entire body or organism, affected patients also have an increased risk of developing psoriatic arthritis and chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis. The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara(R) has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were expanded to treat Crohn's disease and in 2019 it was also approved for the treatment of ulcerative colitis. Both of these conditions are chronic inflammatory bowel diseases. The drug is also used to treat psoriatic arthritis. In 2019, the reference market for Stelara(R) was over USD 6 billion worldwide. FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).お知らせ • Nov 08Formycon AG and Bioeq AG Announce Biologics License Application Resubmission Strategy for Fyb201 Has Been AdjustedFormycon AG and its licensing partner Bioeq AG announced that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted. The approval for FYB201 will be requested directly for a large commercial scale. Formycon and Bioeq are in close coordination with the U.S. Food and Drug Administration (FDA). Through the revised submission strategy, Formycon and Bioeq expect a simplification of the approval procedure. The modified submission dossier is expected to be filed with the FDA in the first half of 2021. The adjustment of the regulatory strategy in the course of optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and European Union countries.Is New 90 Day High Low • Oct 24New 90-day high: €37.50The company is up 62% from its price of €23.10 on 24 July 2020. The German market is down 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 12% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €204 per share.Is New 90 Day High Low • Oct 05New 90-day high: €30.70The company is up 33% from its price of €23.10 on 07 July 2020. The German market is flat over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €199 per share.Reported Earnings • Sep 25First half earnings releasedOver the last 12 months the company has reported total losses of €2.98m, with losses widening by 150% from the prior year. Total revenue was €32.4m over the last 12 months, down 8.9% from the prior year.Price Target Changed • Sep 23Price target raised to €36.28Up from €32.50, the current price target is an average from 4 analysts. The new target price is 23% above the current share price of €29.60. As of last close, the stock is down 2.6% over the past year.お知らせ • Jul 17Formycon AG to Report Q1, 2020 Results on Jun 22, 2020Formycon AG announced that they will report Q1, 2020 results on Jun 22, 2020株主還元FYBDE BiotechsDE 市場7D6.2%0.9%3.2%1Y-10.4%-12.2%2.5%株主還元を見る業界別リターン: FYB過去 1 年間で-12.2 % の収益を上げたGerman Biotechs業界を上回りました。リターン対市場: FYBは、過去 1 年間で2.5 % のリターンを上げたGerman市場を下回りました。価格変動Is FYB's price volatile compared to industry and market?FYB volatilityFYB Average Weekly Movement8.0%Biotechs Industry Average Movement8.7%Market Average Movement6.1%10% most volatile stocks in DE Market13.6%10% least volatile stocks in DE Market2.7%安定した株価: FYB 、 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: FYBの 週次ボラティリティ ( 8% ) 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1999203Stefan Glombitzawww.formycon.comバイオテクノロジー企業であるFormycon AGは、ドイツとスイスでバイオシミラー医薬品の開発を行っている。新生血管加齢黄斑変性、糖尿病黄斑浮腫、脈絡膜新生血管、増殖糖尿病網膜症、黄斑浮腫の治療に使用されるラニビズマブとアフリベルセプトをRanivisio、Ongavia、Cimerli、Ranopto、Uptera、Ravegzaのブランド名で、またAHZANTIVE、Baiama、Fovlyaのブランド名で提供している。同社のパイプラインには、クローン病、潰瘍性大腸炎、尋常性乾癬、乾癬性関節炎の治療に使用されるウステキヌマブがあり、Otulf、Fymskina、Sitovabのブランド名で販売されている。また、進行性黒色腫、非小細胞気管支がん、ホジキンリンパ腫、尿路上皮がん、頭頸部腫瘍、その他の腫瘍性疾患などの免疫腫瘍性疾患の治療薬としてペムブロリズマブを、免疫領域を適応症とするFYB208およびFYB209を開発している。同社は以前はNanohale AGとして知られていたが、2012年に社名をFormycon AGに変更した。フォーミコンAGは1999年に設立され、ドイツのプラネッグに本社を置いている。もっと見るFormycon AG 基礎のまとめFormycon の収益と売上を時価総額と比較するとどうか。FYB 基礎統計学時価総額€354.34m収益（TTM）-€64.70m売上高(TTM)€44.48m8.0xP/Sレシオ-5.5xPER（株価収益率FYB 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FYB 損益計算書（TTM）収益€44.48m売上原価€40.90m売上総利益€3.58mその他の費用€68.27m収益-€64.70m直近の収益報告Dec 31, 2025次回決算日May 28, 2026一株当たり利益（EPS）-3.66グロス・マージン8.04%純利益率-145.46%有利子負債／自己資本比率0%FYB 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2026/05/23 12:21終値2026/05/22 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本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、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。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Formycon AG 6 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。12 アナリスト機関Gerhard OrgonasBerenbergBenjamin ThielmannBerenbergSimon ScholesFirst Berlin Equity Research GmbH9 その他のアナリストを表示
お知らせ • May 05Formycon AG, Annual General Meeting, Jun 10, 2026Formycon AG, Annual General Meeting, Jun 10, 2026, at 10:00 W. Europe Standard Time.
お知らせ • Apr 16Formycon AG to Report Fiscal Year 2025 Results on Apr 22, 2026Formycon AG announced that they will report fiscal year 2025 results at 9:00 AM, Central European Standard Time on Apr 22, 2026
お知らせ • 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
New Risk • Aug 20New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.
Reported Earnings • Aug 19First half 2025 earnings released: €3.07 loss per share (vs €0.58 loss in 1H 2024)First half 2025 results: €3.07 loss per share (further deteriorated from €0.58 loss in 1H 2024). Revenue: €9.00m (down 67% from 1H 2024). Net loss: €54.2m (loss widened 437% from 1H 2024). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 61 percentage points per year, which is a significant difference in performance.
お知らせ • 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.
お知らせ • May 05Formycon AG, Annual General Meeting, Jun 10, 2026Formycon AG, Annual General Meeting, Jun 10, 2026, at 10:00 W. Europe Standard Time.
お知らせ • Apr 16Formycon AG to Report Fiscal Year 2025 Results on Apr 22, 2026Formycon AG announced that they will report fiscal year 2025 results at 9:00 AM, Central European Standard Time on Apr 22, 2026
お知らせ • 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
New Risk • Aug 20New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.
Reported Earnings • Aug 19First half 2025 earnings released: €3.07 loss per share (vs €0.58 loss in 1H 2024)First half 2025 results: €3.07 loss per share (further deteriorated from €0.58 loss in 1H 2024). Revenue: €9.00m (down 67% from 1H 2024). Net loss: €54.2m (loss widened 437% from 1H 2024). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 61 percentage points per year, which is a significant difference in performance.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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).
お知らせ • 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
お知らせ • 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.
お知らせ • 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.
Valuation Update With 7 Day Price Move • Sep 30Investor sentiment improves as stock rises 17%After last week's 17% share price gain to €55.40, the stock trades at a trailing P/E ratio of 14.7x. Average trailing P/E is 26x in the Biotechs industry in Europe. Total returns to shareholders of 8.6% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €75.49 per share.
Reported Earnings • Aug 18First half 2024 earnings released: €0.58 loss per share (vs €0.11 profit in 1H 2023)First half 2024 results: €0.58 loss per share (down from €0.11 profit in 1H 2023). Revenue: €26.9m (down 39% from 1H 2023). Net loss: €10.1m (down €11.9m from profit in 1H 2023). Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 42% per year but the company’s share price has remained flat, which means it is significantly lagging earnings.
お知らせ • 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
Valuation Update With 7 Day Price Move • Jun 06Investor sentiment improves as stock rises 15%After last week's 15% share price gain to €49.55, the stock trades at a trailing P/E ratio of 11.4x. Average trailing P/E is 26x in the Biotechs industry in Europe. Total loss to shareholders of 19% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €27.46 per share.
Price Target Changed • May 12Price target decreased by 8.7% to €87.00Down from €95.25, the current price target is an average from 6 analysts. New target price is 102% above last closing price of €43.05. Stock is down 44% over the past year. The company is forecast to post a net loss per share of €1.05 compared to earnings per share of €4.76 last year.
お知らせ • 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
Reported Earnings • Apr 25Full year 2023 earnings released: EPS: €4.76 (vs €2.62 in FY 2022)Full year 2023 results: EPS: €4.76 (up from €2.62 in FY 2022). Revenue: €77.7m (up 83% from FY 2022). Net income: €75.8m (up 111% from FY 2022). Profit margin: 98% (up from 85% in FY 2022). The increase in margin was primarily driven by higher revenue. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 16% per year, which means it is significantly lagging earnings.
お知らせ • 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
Price Target Changed • Apr 11Price target decreased by 12% to €96.25Down from €109, the current price target is an average from 4 analysts. New target price is 109% above last closing price of €46.00. Stock is down 31% over the past year. The company is forecast to post earnings per share of €3.38 for next year compared to €2.62 last year.
New Risk • Apr 01New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 10% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company.
Price Target Changed • Jan 30Price target decreased by 8.9% to €105Down from €115, the current price target is an average from 5 analysts. New target price is 110% above last closing price of €50.10. Stock is down 40% over the past year. The company is forecast to post earnings per share of €0.023 for next year compared to €2.62 last year.
New Risk • Oct 14New 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 6.1% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (6.1% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding).
Price Target Changed • Sep 20Price target decreased by 7.5% to €107Down from €115, the current price target is an average from 5 analysts. New target price is 83% above last closing price of €58.30. Stock is down 19% over the past year. The company is forecast to post a net loss per share of €1.76 compared to earnings per share of €2.62 last year.
Reported Earnings • Sep 08First half 2023 earnings released: EPS: €0.11 (vs €6.51 in 1H 2022)First half 2023 results: EPS: €0.11 (down from €6.51 in 1H 2022). Revenue: €43.8m (up 148% from 1H 2022). Net income: €1.80m (down 98% from 1H 2022). Profit margin: 4.1% (down from 454% in 1H 2022). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has only increased by 30% per year, which means it is significantly lagging earnings growth.
お知らせ • 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
Price Target Changed • Aug 22Price target decreased by 8.8% to €115Down from €126, the current price target is an average from 3 analysts. New target price is 95% above last closing price of €59.00. Stock is down 30% over the past year. The company is forecast to post a net loss per share of €1.64 compared to earnings per share of €2.62 last year.
New Risk • Jul 07New 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 6.7% 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 High level of non-cash earnings (39% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (6.7% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding).
お知らせ • 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.
Valuation Update With 7 Day Price Move • May 18Investor sentiment improves as stock rises 16%After last week's 16% share price gain to €77.40, the stock trades at a trailing P/E ratio of 34.6x. Average forward P/E is 32x in the Biotechs industry in Europe. Total returns to shareholders of 216% over the past three years.
Reported Earnings • Apr 29Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behindFull 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 missed analyst estimates by 1.2%. Earnings per share (EPS) exceeded analyst estimates by 114%. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. 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 44% per year, which means it is significantly lagging earnings growth.
お知らせ • 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
Price Target Changed • Nov 16Price target increased to €126Up from €97.67, the current price target is an average from 3 analysts. New target price is 76% above last closing price of €71.80. Stock is up 45% over the past year. The company is forecast to post earnings per share of €3.19 next year compared to a net loss per share of €1.22 last year.
Reported Earnings • Nov 01First half 2022 earnings released: EPS: €6.51 (vs €0.92 loss in 1H 2021)First half 2022 results: EPS: €6.51 (up from €0.92 loss in 1H 2021). Revenue: €17.6m (down 13% from 1H 2021). Net income: €80.0m (up €90.2m from 1H 2021). Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 78% per year but the company’s share price has only increased by 31% per year, which means it is significantly lagging earnings growth.
Price Target Changed • Sep 19Price target increased to €107Up from €95.67, the current price target is an average from 3 analysts. New target price is 52% above last closing price of €70.60. Stock is up 37% over the past year. The company is forecast to post earnings per share of €3.05 next year compared to a net loss per share of €1.22 last year.
Reported Earnings • May 22Full year 2021 earnings: EPS and revenues miss analyst expectationsFull year 2021 results: €1.22 loss per share (down from €0.54 loss in FY 2020). Revenue: €37.0m (up 8.0% from FY 2020). Net loss: €13.5m (loss widened 127% from FY 2020). Products in clinical trials Phase III: 2 Revenue missed analyst estimates by 9.5%. Earnings per share (EPS) also missed analyst estimates by 2.6%. Over the next year, revenue is forecast to grow 6.6%, compared to a 29% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 132 percentage points per year, which is a significant difference in performance.
Price Target Changed • Apr 28Price target increased to €87.00Up from €72.25, the current price target is an average from 4 analysts. New target price is 35% above last closing price of €64.30. Stock is down 3.0% over the past year. The company is forecast to post a net loss per share of €1.49 next year compared to a net loss per share of €0.54 last year.
Price Target Changed • Apr 14Price target increased to €75.00Up from €70.00, the current price target is an average from 4 analysts. New target price is 12% above last closing price of €67.10. Stock is up 9.8% over the past year. The company is forecast to post a net loss per share of €1.56 next year compared to a net loss per share of €0.54 last year.
Price Target Changed • Sep 29Price target decreased to €70.00Down from €82.00, the current price target is an average from 4 analysts. New target price is 42% above last closing price of €49.15. Stock is up 67% over the past year.
Reported Earnings • Sep 24First half 2021 earnings released: €0.92 loss per share (vs €0.14 loss in 1H 2020)The company reported a soft first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: €20.3m (up 23% from 1H 2020). Net loss: €10.2m (loss widened €8.79m from 1H 2020). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 138 percentage points per year, which is a significant difference in performance.
Reported Earnings • May 19Full year 2020 earnings releasedThe company reported a soft full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: €34.6m (up 4.5% from FY 2019). Net loss: €5.93m (loss widened 158% from FY 2019).
Is New 90 Day High Low • Feb 12New 90-day high: €75.40The company is up 118% from its price of €34.60 on 13 November 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €386 per share.
Price Target Changed • Dec 11Price target raised to €46.45Up from €38.45, the current price target is an average from 5 analysts. The new target price is 15% below the current share price of €54.40. As of last close, the stock is up 78% over the past year.
Is New 90 Day High Low • Dec 10New 90-day high: €51.00The company is up 88% from its price of €27.10 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €245 per share.
お知らせ • Nov 09Formycon AG and Bioeq GmbH Announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R) (Ustekinumab)Formycon AG and Bioeq GmbH announced the dosage of the first patient in the Phase III clinical trial (first-patient-in). The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris. This is the most common form of psoriasis, accounting for 80% to 90% of its occurrence, and is also known as plaque psoriasis. Due to this systemic disease affecting the entire body or organism, affected patients also have an increased risk of developing psoriatic arthritis and chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis. The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara(R) has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were expanded to treat Crohn's disease and in 2019 it was also approved for the treatment of ulcerative colitis. Both of these conditions are chronic inflammatory bowel diseases. The drug is also used to treat psoriatic arthritis. In 2019, the reference market for Stelara(R) was over USD 6 billion worldwide. FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).
お知らせ • Nov 08Formycon AG and Bioeq AG Announce Biologics License Application Resubmission Strategy for Fyb201 Has Been AdjustedFormycon AG and its licensing partner Bioeq AG announced that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted. The approval for FYB201 will be requested directly for a large commercial scale. Formycon and Bioeq are in close coordination with the U.S. Food and Drug Administration (FDA). Through the revised submission strategy, Formycon and Bioeq expect a simplification of the approval procedure. The modified submission dossier is expected to be filed with the FDA in the first half of 2021. The adjustment of the regulatory strategy in the course of optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and European Union countries.
Is New 90 Day High Low • Oct 24New 90-day high: €37.50The company is up 62% from its price of €23.10 on 24 July 2020. The German market is down 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 12% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €204 per share.
Is New 90 Day High Low • Oct 05New 90-day high: €30.70The company is up 33% from its price of €23.10 on 07 July 2020. The German market is flat over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €199 per share.
Reported Earnings • Sep 25First half earnings releasedOver the last 12 months the company has reported total losses of €2.98m, with losses widening by 150% from the prior year. Total revenue was €32.4m over the last 12 months, down 8.9% from the prior year.
Price Target Changed • Sep 23Price target raised to €36.28Up from €32.50, the current price target is an average from 4 analysts. The new target price is 23% above the current share price of €29.60. As of last close, the stock is down 2.6% over the past year.
お知らせ • Jul 17Formycon AG to Report Q1, 2020 Results on Jun 22, 2020Formycon AG announced that they will report Q1, 2020 results on Jun 22, 2020
