Aankondiging • May 30
Formycon Ag Confirms Earnings Guidance for the Fiscal Year 2026 Formycon AG confirmed earnings guidance for the fiscal year 2026. For the financial year 2026, the Formycon Group expects revenue to increase to a range of €60.0 million and €70.0 million. Reported Earnings • May 29
First quarter 2026 earnings released: €0.85 loss per share (vs €1.53 loss in 1Q 2025) First quarter 2026 results: €0.85 loss per share (improved from €1.53 loss in 1Q 2025). Revenue: €13.1m (up 191% from 1Q 2025). Net loss: €15.0m (loss narrowed 45% from 1Q 2025). Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 62% per year but the company’s share price has only fallen by 32% per year, which means it has not declined as severely as earnings. Aankondiging • May 05
Formycon AG, Annual General Meeting, Jun 10, 2026 Formycon AG, Annual General Meeting, Jun 10, 2026, at 10:00 W. Europe Standard Time. Reported Earnings • Apr 24
Full year 2025 earnings: EPS and revenues miss analyst expectations Full year 2025 results: €3.66 loss per share (improved from €7.19 loss in FY 2024). Revenue: €44.5m (down 36% from FY 2024). Net loss: €64.7m (loss narrowed 49% from FY 2024). Revenue missed analyst estimates by 8.2%. Earnings per share (EPS) also missed analyst estimates by 81%. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 14% 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 42 percentage points per year, which is a significant difference in performance. Aankondiging • Apr 16
Formycon AG to Report Fiscal Year 2025 Results on Apr 22, 2026 Formycon AG announced that they will report fiscal year 2025 results at 9:00 AM, Central European Standard Time on Apr 22, 2026 New Risk • Apr 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.3% 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. This is currently the only risk that has been identified for the company. Major Estimate Revision • Mar 08
Consensus EPS estimates fall by 15% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -€1.81 to -€2.09 per share. Revenue forecast of €55.2m unchanged since last update. Biotechs industry in Germany expected to see average net income growth of 16% next year. Consensus price target down from €41.86 to €40.71. Share price fell 14% to €19.74 over the past week. Buy Or Sell Opportunity • Jan 15
Now 21% undervalued Over the last 90 days, the stock has risen 3.9% to €24.20. The fair value is estimated to be €30.70, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 3.0% over the last 3 years. Meanwhile, the company became loss making. Revenue is forecast to grow by 61% in a year. Earnings are forecast to grow by 91% in the next year. New Risk • Dec 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.7% 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. This is currently the only risk that has been identified for the company. New Risk • Nov 20
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: €170m Forecast net loss in 2 years: €560k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. Major Estimate Revision • Nov 15
Consensus estimates of losses per share improve by 11% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has improved. 2025 revenue forecast increased from €54.2m to €54.9m. EPS estimate increased from -€2.16 per share to -€1.91 per share. Biotechs industry in Germany expected to see average net income growth of 22% next year. Consensus price target of €43.63 unchanged from last update. Share price rose 7.5% to €20.75 over the past week. Major Estimate Revision • Aug 31
Consensus EPS estimates fall by 12% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -€1.88 to -€2.11 per share. Revenue forecast unchanged at €54.9m. Biotechs industry in Germany expected to see average net income growth of 15% next year. Consensus price target of €43.75 unchanged from last update. Share price was steady at €24.15 over the past week. Major Estimate Revision • Aug 20
Consensus EPS estimates fall by 12% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from €56.4m to €54.9m. Losses expected to increase from €1.69 per share to €1.90. Biotechs industry in Germany expected to see average net income growth of 16% next year. Consensus price target broadly unchanged at €43.75. Share price was steady at €24.60 over the past week. Reported Earnings • Aug 19
First 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. Major Estimate Revision • Aug 05
Consensus EPS estimates fall by 21% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -€1.40 to -€1.69 per share. Revenue forecast unchanged at €56.4m. Biotechs industry in Germany expected to see average net income growth of 16% next year. Consensus price target broadly unchanged at €44.25. Share price fell 14% to €25.40 over the past week. Aankondiging • Jul 11
Formycon AG Completes Patient Enrollment for the Clinical Development of Its Keytruda®? Biosimilar Candidate FYB206 Formycon 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. Price Target Changed • Jul 01
Price target decreased by 11% to €44.13 Down from €49.33, the current price target is an average from 8 analysts. New target price is 60% above last closing price of €27.55. Stock is down 50% over the past year. The company is forecast to post a net loss per share of €1.37 next year compared to a net loss per share of €7.18 last year. Aankondiging • Jun 20
Formycon Ag Elects Graham Keith Dixon as A New Member of the Supervisory Board Formycon AG announced that Graham Keith Dixon elected as a new member of the Supervisory Board. Aankondiging • May 13
Formycon AG Provides Earnings Guidance for the Year 2025 Formycon AG provided earnings guidance for the year 2025. The company expects Revenue to be €55.0 million to €65.0 million. Price Target Changed • Mar 31
Price target decreased by 8.4% to €49.56 Down from €54.11, the current price target is an average from 9 analysts. New target price is 116% above last closing price of €22.90. Stock is down 51% over the past year. The company is forecast to post a net loss per share of €1.25 next year compared to a net loss per share of €7.18 last year. Reported Earnings • Mar 30
Full year 2024 earnings released: €7.19 loss per share (vs €4.76 profit in FY 2023) Full year 2024 results: €7.19 loss per share (down from €4.76 profit in FY 2023). Revenue: €69.7m (down 10% from FY 2023). Net loss: €125.7m (down 266% from profit in FY 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 43% per year but the company’s share price has only fallen by 27% per year, which means it has not declined as severely as earnings. Aankondiging • Mar 28
Formycon AG Provides Earnings Guidance for the Year 2025 Formycon 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. Major Estimate Revision • Mar 16
Consensus EPS estimates upgraded to €2.88 loss, revenue downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from €60.5m to €59.5m. 2024 losses expected to reduce from -€3.22 to -€2.88 per share. Biotechs industry in Germany expected to see average net income growth of 11% next year. Consensus price target down from €60.44 to €54.11. Share price rose 6.8% to €27.60 over the past week. Price Target Changed • Mar 10
Price target decreased by 10% to €54.11 Down from €60.44, the current price target is an average from 9 analysts. New target price is 115% above last closing price of €25.15. Stock is down 48% over the past year. The company is forecast to post a net loss per share of €3.21 compared to earnings per share of €4.76 last year. Major Estimate Revision • Mar 05
Consensus EPS estimates upgraded to €2.87 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -€3.22 to -€2.87 per share. Revenue forecast unchanged from €59.8m at last update. Biotechs industry in Germany expected to see average net income growth of 16% next year. Consensus price target down from €60.44 to €58.67. Share price fell 4.3% to €26.50 over the past week. Aankondiging • Mar 04
Fresenius 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. Major Estimate Revision • Feb 19
Consensus EPS estimates fall by 252% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -€0.483 to -€1.70 per share. Revenue forecast unchanged at €60.5m. Biotechs industry in Germany expected to see average net income growth of 16% next year. Consensus price target down from €87.22 to €72.89. Share price fell 41% to €29.90 over the past week. Price Target Changed • Feb 18
Price target decreased by 15% to €74.25 Down from €87.00, the current price target is an average from 8 analysts. New target price is 124% above last closing price of €33.20. Stock is down 38% over the past year. The company is forecast to post a net loss per share of €0.89 compared to earnings per share of €4.76 last year. New Risk • Feb 17
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 5.7% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (5.7% average weekly change). High level of non-cash earnings (27% accrual ratio). Valuation Update With 7 Day Price Move • Feb 17
Investor sentiment deteriorates as stock falls 38% After last week's 38% share price decline to €32.60, the stock trades at a forward P/E ratio of 781x. Average trailing P/E is 26x in the Biotechs industry in Europe. Total loss to shareholders of 32% over the past three years. Aankondiging • Feb 17
Formycon AG Announces Decision on Phase III Trial with FYB206 and Provides Update on Potential Need to Adjust the Valuation of FYB202 and FYB201 Formycon 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. Aankondiging • Jan 21
Formycon Receives EU Approval for FYB203 (Aflibercept), A Biosimilar to Eylea, Under the Brand Names Ahzantive and Baiama Formycon 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. Aankondiging • Jan 16
Formycon AG and Fresenius Kabi Announce MHRA Approval for FYB202/Otulfi (Ustekinumab), Biosimilar to Stelara Formycon 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). Valuation Update With 7 Day Price Move • Jan 10
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to €62.70, the stock trades at a forward P/E ratio of 1503x. Average trailing P/E is 28x in the Biotechs industry in Europe. Total returns to shareholders of 29% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €45.24 per share. Buy Or Sell Opportunity • Jan 07
Now 32% overvalued after recent price rise Over the last 90 days, the stock has risen 16% to €59.50. The fair value is estimated to be €45.04, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 28% over the last 3 years. Meanwhile, the company has become profitable. For the next 3 years, revenue is forecast to grow by 25% per annum. Earnings are also forecast to grow by 23% per annum over the same time period. Major Estimate Revision • Dec 12
Consensus EPS estimates upgraded to €0.48 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -€0.545 to -€0.483 per share. Revenue forecast steady at €60.4m. Biotechs industry in Germany expected to see average net income growth of 26% next year. Consensus price target of €86.56 unchanged from last update. Share price rose 4.1% to €53.20 over the past week. Major Estimate Revision • Nov 29
Consensus EPS estimates upgraded to €0.56 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -€0.664 to -€0.555 per share. Revenue forecast steady at €60.3m. Biotechs industry in Germany expected to see average net income growth of 28% next year. Consensus price target of €86.56 unchanged from last update. Share price rose 6.6% to €49.95 over the past week. Aankondiging • Nov 15
Formycon AG Appoints Colin Bond as Director In 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. Aankondiging • Oct 01
Fresenius 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. Major Estimate Revision • Aug 29
Consensus EPS estimates upgraded to €0.70 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -€0.958 to -€0.698 per share. Revenue forecast steady at €60.5m. Biotechs industry in Germany expected to see average net income growth of 6.3% next year. Consensus price target broadly unchanged at €84.78. Share price was steady at €51.70 over the past week. Major Estimate Revision • Aug 21
Consensus EPS estimates upgraded to €0.96 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -€1.08 to -€0.958 per share. Revenue forecast steady at €60.0m. Biotechs industry in Germany expected to see average net income growth of 6.8% next year. Consensus price target broadly unchanged at €86.33. Share price fell 2.9% to €49.40 over the past week. Reported Earnings • Aug 18
First 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 fallen by 1% per year, which means it is significantly lagging earnings. Buy Or Sell Opportunity • Aug 17
Now 21% undervalued Over the last 90 days, the stock has risen 11% to €49.20. The fair value is estimated to be €61.92, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 28% over the last 3 years. Meanwhile, the company has become profitable. For the next 3 years, revenue is forecast to grow by 33% per annum. Earnings are also forecast to grow by 31% per annum over the same time period. Aankondiging • Aug 06
Formycon AG to Report First Half, 2024 Results on Aug 13, 2024 Formycon AG announced that they will report first half, 2024 results on Aug 13, 2024 New Risk • Aug 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.8% 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 (24% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (6.8% average weekly change). Shareholders have been diluted in the past year (10% increase in shares outstanding). Valuation Update With 7 Day Price Move • Jun 26
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to €55.80, the stock trades at a trailing P/E ratio of 13x. Average trailing P/E is 28x in the Biotechs industry in Europe. Total loss to shareholders of 12% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €55.29 per share. Valuation Update With 7 Day Price Move • Jun 06
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to €49.85, the stock trades at a trailing P/E ratio of 11.6x. Average trailing P/E is 26x in the Biotechs industry in Europe. Total loss to shareholders of 18% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €26.93 per share. Price Target Changed • May 13
Price target decreased by 8.7% to €87.00 Down from €95.25, the current price target is an average from 6 analysts. New target price is 104% above last closing price of €42.75. Stock is down 46% 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. Aankondiging • May 03
Formycon AG to Report Q1, 2024 Results on May 08, 2024 Formycon AG announced that they will report Q1, 2024 results on May 08, 2024 Reported Earnings • Apr 25
Full 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. Aankondiging • Apr 13
Formycon AG to Report Fiscal Year 2023 Final Results on Apr 25, 2024 Formycon AG announced that they will report fiscal year 2023 final results on Apr 25, 2024 Price Target Changed • Apr 11
Price target decreased by 12% to €96.25 Down from €109, the current price target is an average from 4 analysts. New target price is 109% above last closing price of €45.95. 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 01
New minor risk - Shareholder dilution The 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 31
Price target decreased by 7.9% to €103 Down from €112, the current price target is an average from 5 analysts. New target price is 101% above last closing price of €51.30. Stock is down 38% 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. Aankondiging • Jan 30
Formycon AG has completed a Follow-on Equity Offering in the amount of €82.840247 million. Formycon AG has completed a Follow-on Equity Offering in the amount of €82.840247 million.
Security Name: Bearer Shares
Security Type: Common Stock
Securities Offered: 1,603,877
Price\Range: €51.65
Transaction Features: Subsequent Direct Listing New Risk • Oct 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of 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). Reported Earnings • Sep 08
First 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 29% per year, which means it is significantly lagging earnings growth. Aankondiging • Aug 24
Formycon AG to Report First Half, 2023 Results on Aug 30, 2023 Formycon AG announced that they will report first half, 2023 results on Aug 30, 2023 Major Estimate Revision • Aug 09
Consensus EPS estimates fall by 146% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from €81.3m to €78.3m. Losses expected to increase from €0.51 per share to €1.26. Biotechs industry in Germany expected to see average net income growth of 6.1% next year. Consensus price target of €116 unchanged from last update. Share price was steady at €67.10 over the past week. Price Target Changed • Jul 24
Price target decreased by 8.6% to €116 Down from €126, the current price target is an average from 2 analysts. New target price is 82% above last closing price of €63.50. Stock is down 18% over the past year. The company is forecast to post a net loss per share of €0.49 compared to earnings per share of €2.62 last year. Aankondiging • Jun 29
Formycon 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 18
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to €77.60, 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 209% over the past three years. Reported Earnings • Apr 30
Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind 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 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 46% per year, which means it is significantly lagging earnings growth. Aankondiging • Feb 03
Formycon 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 16
Price target increased to €126 Up from €97.67, the current price target is an average from 3 analysts. New target price is 70% above last closing price of €74.30. Stock is up 50% 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 • Oct 31
First 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 19% 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 32% per year, which means it is significantly lagging earnings growth. Aankondiging • Sep 20
Formycon AG Publishes Details of A Previously Undisclosed Pipeline Project – Fyb206 Is A Biosimilar Candidate for Keytruda (Pembrolizumab) Formycon AG announced details of a previously undisclosed project in its development pipeline. FYB206 is a biosimilar candidate for Keytruda® (pembrolizumab) and the development is at an advanced preclinical stage. In addition to biosimilars in the field of ophthalmology (FYB201/FYB203), immunology (FYB202) and two further yet unpublished biosimilar candidates (FYB208/FYB209), Formycon is expanding its therapeutic range with FYB206 to the rapidly growing field of immuno-oncology. The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is established in the treatment of a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system activate the body's own cellular anti-tumor immune response and kill e.g. melanoma cells. Since 2015, Keytruda® has been established for the treatment of advanced melanoma, lung and other types of carcinoma. In 2021, the reference market for Keytruda® was reported at a size of more than USD 17 billion worldwide.[i] Expert analyses predict that Keytruda® will become the world's top-selling drug in 2023, with annual revenue potential expected to be well over USD 20 billion as early as 2025. The development and commercialization rights for FYB206 are fully owned by Formycon. Important IP has already been created and patent applications have been filed, with data from the development of alternative formulations. Following convincing results from the extensive analytical protein characterization as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely align further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Adjusting the manufacturing process to commercial scale is planned for the end of 2022. For this purpose, Formycon has already secured GMP manufacturing capacities at a renowned contract manufacturer. Price Target Changed • Sep 19
Price target increased to €107 Up from €95.67, the current price target is an average from 3 analysts. New target price is 53% above last closing price of €70.30. Stock is up 36% 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. Major Estimate Revision • Sep 07
Consensus forecasts updated The consensus outlook for 2022 has been updated. Forecast profits in 2022 with EPS up from -€1.09 to €3.05 per share. Revenue forecast unchanged from last update at €41.9m. Biotechs industry in Germany expected to see average net income growth of 8.6% next year. Consensus price target of €97.67 unchanged from last update. Share price fell 4.4% to €72.20 over the past week. Aankondiging • Aug 29
Formycon AG, Polpharma Biologics Group BV and Bioeq AG Announce European Commission Approval for FYB201/Ranivisio1 (Ranivisio - Ranibizumab), a Biosimilar to Lucentis2 (News with Additional Features) Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce that the European Commission (“EC”) has granted marketing authorization (“MA”) for Ranivisio (Ranivisio - Ranibizumab), a biosimilar to Lucentis (ranibizumab-injection), for the treatment for several serious retinal diseases in the European Union. EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Ranivisio is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). FYB201/Ranivisio was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and selected other countries. Commercial launches across Europe are planned over the coming year, and the treatment is already available in the UK under the tradename Ongavia3, following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022. The EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio is highly similar to the reference product Lucentis in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration. AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries AMD is the most common cause of severe visual impairment or blindness and it is estimated that up to 77 million Europeans will be affected by 2050. The consequences of AMD carry a significant burden for healthcare systems and societies as the increasing incidence of the condition is expected to absorb considerable amounts of healthcare resources and funds across the EU. Aankondiging • Aug 27
Formycon Ag Announces EU-Approval of FYB201/Ranivisio A Biosimilar to Lucentis Formycon AG announced that the European Commission (EC) has granted marketing authorization (MA) for Ranivisio®, a biosimilar to Lucentis® (ranibizumab-injection) for medical use in the European Union (EU). FYB201/Ranivisio® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (Teva) entered into a strategic partnership for the exclusive commercialization of FYB201 under the brand name Ranivisio® in the EU. The commercial launch of Ranivisio® in the EU is planned as soon as possible. The European Commission now followed the positive opinion issued by the Committee for Medicinal Products for Human Use ("CHMP") in June 2022 and approved Ranivisio® for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). The EU-approval is based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio® is highly similar to the reference product Lucentis® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration. Aankondiging • Aug 16
Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara in Phase III Study Formycon AG reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara-(Ustekinumab). The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara- in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). This is the most common form of psoriasis, accounting for 80% to 90% of all cases. The primary endpoint of the comparative global Phase III study measures the % improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline. The values obtained for FYB202 and reference product are within the relevant equivalence limits. In addition, to date, no clinically meaningful differences in safety and immunogenicity have been observed. The extended Phase I pharmacokinetics study has commenced. Recruitment is evolving according to plan and a substantial number of subjects has already been enrolled in the study. The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara- has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn's disease (2016) and ulcerative colitis (2019). Stelara- achieved a global sales volume of over USD 9 billion in 2021. As a result of the transaction with ATHOS KG, which was successfully concluded in the first half of 2022, the global commercialization rights to FYB202 are held in full by Formycon AG (prior to the transaction 24.9% co-ownership share). Aankondiging • Aug 04
Formycon Announces FDA Approval of Fyb201/Cimerlitm1 (Ranibizumab-EQRN) as A Biosimilar Interchangeable with Lucentis®2 Formycon AG announced that the U.S. Food and Drug Administration ("FDA") has approved CIMERLIT (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis- (ranibizumab injection). FYB201 was developed by Bioeq AG, a Joint Venture between Formycon AG and Polpharma Biologics Group BV. End of the year 2019, Coherus BioSciences Inc. ("Coherus") entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLIT in the United States of America ("U.S."). The commercial launch of CIMERLIT, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October 2022. CIMERLIT obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLIT is the first and only interchangeable biosimilar with an exclusivity for 12 month after market launch, that is indicated for the treatment of all five Lucentis- indications and as such is a new medical option for patients with serious retinal diseases. FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLIT were found to be comparable to the reference drug Lucentis- in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). Major Estimate Revision • Jul 12
Consensus revenue estimates increase by 13% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from €32.9m to €37.1m. Forecast losses expected to reduce from -€1.44 to -€1.09 per share. Biotechs industry in Germany expected to see average net income growth of 11% next year. Consensus price target up from €93.00 to €95.67. Share price fell 3.0% to €74.00 over the past week. Aankondiging • Jul 02
Formycon AG Announces Supervisory Board and Executive Changes Formycon AG at it's AGM elected Dr. Thomas Strüngmann to the Supervisory Board and Dr. Andreas Seidl, the future Chief Scientific Officer (CSO), who was appointed to the Management Board by the Supervisory Board effective July 01, 2022. Aankondiging • Jun 25
Formycon's Biosimilar for Lucentis (Ranibizumab), Receives CHMP Recommendation from EMA Formycon AG and its licensing partner Bioeq AG announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") issued a positive opinion for FYB201, a biosimilar to Lucentis. FYB201 has thus been recommended for approval in the European Union (EU) for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious ocular diseases such as diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), macular edema due to retinal vein occlusion (branch RVO or central RVO) and choroidal neovascularization (CNV). The CHMP recommendation is based on an in-depth evaluation of a comprehensive set of data for comparative analytical characterization and commercial-scale manufacturing. In a randomized, double-blind, multicenter, parallel-group Phase III study, FYB201 also demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Lucentis- (ranibizumab) in patients with age-related neovascular (wet) macular degeneration.Within the approval process, the CHMP's favorable opinion represents an important regulatory step towards the approval of FYB201 in the European Union. The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant a central marketing authorization, which is expected at the end of August. 
