- Formycon terminates Phase III study (“Lotus”) for FYB206 following positive feedback from the U.S. Food and Drug Administration (FDA)
- Anticipated price reductions for Stelara®1 biosimilars in the U.S. likely to require an adjustment in the valuation of FYB202
- Discussions initiated with commercialization partner Sandoz AG on the future U.S. commercialization strategy for FYB201/CIMERLI®2 due to increasing price discounts
PLANEGG-MARTINSRIED I Germany I February 17, 2025 I The Executive Board of Formycon AG (FSE: FYB, Prime Standard) (“Company”) has decided today to prematurely terminate the Phase III trial (“Lotus”) for its biosimilar candidate FYB206. 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 FYB206 in the U.S. The therapeutic comparability of FYB206 with the reference drug Keytruda®3 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 FYB202/Otulfi™4 in the U.S., Formycon anticipates that the valuation model and balance sheet measurement for FYB202 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 FYB201/CIMERLI®, is currently in discussions with its commercialization partner Sandoz AG regarding the future commercialization strategy for FYB201/CIMERLI® in the U.S. Based on the status of these discussions, Formycon currently expects that the commercialization of FYB201/CIMERLI® will likely be temporarily paused. This would result in an extraordinary adjustment to the valuation model and the balance sheet measurement for FYB201, 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.
Further details regarding the aforementioned matters and their specific financial implications for the company, including the forecast for the 2025 financial year, are currently being reviewed by the company and are expected to be communicated no later than with the publication of the final financial results for the 2024 financial year on March 27, 2025.
Formycon currently assumes that the key financial forecast figures for the 2024 financial year will not be affected by these adjustments. The company’s net result, however, is expected to be negatively impacted by the impairment related to FYB202 and FYB201.
1) Stelara® is a registered trademark of Johnson & Johnson
2) CIMERLI® is a registered trademark of Coherus BioSciences, Inc
3) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
4) OtulfiTM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Important Notice:
This announcement and the information contained herein are for informational purposes only and do not constitute a prospectus or an offer to sell or a solicitation of an offer to buy any securities of the Company in the United States of America (including its territories and possessions, the states of the United States of America and the District of Columbia) (“United States”) or any other jurisdiction. This publication may not be distributed, published or circulated in the United States, Australia, Canada, Japan and other countries where such distribution or publication may be unlawful.
The Company’s securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act, or in a transaction not subject to the registration requirements of the Securities Act. or the applicable securities laws of Australia, Canada or Japan. There will be no public offering of shares of the Company.
The distribution of this announcement may be restricted by law in certain jurisdictions and persons in possession this announcement or the information referred to herein should inform themselves about and observe any such restrictions. Failure to comply with such restrictions may constitute a violation of the securities laws of such jurisdictions.
About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market (“Scale”) of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).
About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than USD 15 billion. By 2030, analysts estimate that this figure could rise to over USD 74 billion.
SOURCE: Formycon
Post Views: 583
- Formycon terminates Phase III study (“Lotus”) for FYB206 following positive feedback from the U.S. Food and Drug Administration (FDA)
- Anticipated price reductions for Stelara®1 biosimilars in the U.S. likely to require an adjustment in the valuation of FYB202
- Discussions initiated with commercialization partner Sandoz AG on the future U.S. commercialization strategy for FYB201/CIMERLI®2 due to increasing price discounts
PLANEGG-MARTINSRIED I Germany I February 17, 2025 I The Executive Board of Formycon AG (FSE: FYB, Prime Standard) (“Company”) has decided today to prematurely terminate the Phase III trial (“Lotus”) for its biosimilar candidate FYB206. 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 FYB206 in the U.S. The therapeutic comparability of FYB206 with the reference drug Keytruda®3 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 FYB202/Otulfi™4 in the U.S., Formycon anticipates that the valuation model and balance sheet measurement for FYB202 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 FYB201/CIMERLI®, is currently in discussions with its commercialization partner Sandoz AG regarding the future commercialization strategy for FYB201/CIMERLI® in the U.S. Based on the status of these discussions, Formycon currently expects that the commercialization of FYB201/CIMERLI® will likely be temporarily paused. This would result in an extraordinary adjustment to the valuation model and the balance sheet measurement for FYB201, 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.
Further details regarding the aforementioned matters and their specific financial implications for the company, including the forecast for the 2025 financial year, are currently being reviewed by the company and are expected to be communicated no later than with the publication of the final financial results for the 2024 financial year on March 27, 2025.
Formycon currently assumes that the key financial forecast figures for the 2024 financial year will not be affected by these adjustments. The company’s net result, however, is expected to be negatively impacted by the impairment related to FYB202 and FYB201.
1) Stelara® is a registered trademark of Johnson & Johnson
2) CIMERLI® is a registered trademark of Coherus BioSciences, Inc
3) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
4) OtulfiTM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Important Notice:
This announcement and the information contained herein are for informational purposes only and do not constitute a prospectus or an offer to sell or a solicitation of an offer to buy any securities of the Company in the United States of America (including its territories and possessions, the states of the United States of America and the District of Columbia) (“United States”) or any other jurisdiction. This publication may not be distributed, published or circulated in the United States, Australia, Canada, Japan and other countries where such distribution or publication may be unlawful.
The Company’s securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act, or in a transaction not subject to the registration requirements of the Securities Act. or the applicable securities laws of Australia, Canada or Japan. There will be no public offering of shares of the Company.
The distribution of this announcement may be restricted by law in certain jurisdictions and persons in possession this announcement or the information referred to herein should inform themselves about and observe any such restrictions. Failure to comply with such restrictions may constitute a violation of the securities laws of such jurisdictions.
About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market (“Scale”) of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).
About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than USD 15 billion. By 2030, analysts estimate that this figure could rise to over USD 74 billion.
SOURCE: Formycon
Post Views: 583
