Europe Revokes Approvals for Generics of Biogen’s MS Drug Tecfidera

December 20, 2023

🌥️Trending News

Biogen Inc ($NASDAQ:BIIB). is a biotechnology company based in Cambridge, Massachusetts. The company focuses on the discovery, development, and delivery of innovative therapies for the treatment of neurological, autoimmune, and neurodegenerative diseases. Recently, the European Commission has withdrawn its authorization of generic versions of Biogen’s multiple sclerosis medication Tecfidera. Biogen had requested that the European Medicines Agency (EMA) review the authorization of generic versions of Tecfidera. The EMA found that the generics had not been tested against the original drug and could not be considered as therapeutic equivalents.

As a result, the European Commission has revoked all authorizations for generic versions of Tecfidera. This decision is a major blow to the company as it means that generic versions of Tecfidera can no longer be sold in the EU. It also puts pressure on Biogen’s pricing strategy in Europe, as there will be no competition from generic drugs. While Biogen will still have exclusive rights to sell Tecfidera in the EU for the time being, it is likely that the company will face increased pressure from health authorities to lower prices.

Price History

On Tuesday, BIOGEN INC experienced a minor uptick in their stock prices, with the opening price of $250.3 and a closing price of $251.7, representing an increase of 0.5% from the prior closing price. This increase comes despite the news that Europe has revoked approvals for generics of BIOGEN INC’s multiple sclerosis drug, Tecfidera. The revocation applies to generics developed by both Mylan and Accord Healthcare as well as other, unnamed companies. This will likely lead to a decrease in competition for BIOGEN INC’s Tecfidera, which may result in more sustained stock prices in the near future. Live Quote…

About the Company

  • Industry Classification
  • Key Executives
  • Ownership (Institutional/ Fund Holdings)
  • News Feed
  • Income Snapshot

    Below shows the total revenue, net income and net margin for Biogen Inc. More…

    Total Revenues Net Income Net Margin
    9.99k 1.46k 18.0%
  • Income Statement Reports (Yearly/ Quarterly/ LTM)
  • Income Supplement
  • Growth Performance
  • Cash Flow Snapshot

    Below shows the cash from operations, investing and financing for Biogen Inc. More…

    Operations Investing Financing
    1.36k -3.59k 788
  • Cash Flow Statement (Yearly/ Quarterly/ LTM)
  • Cash Flow Supplement
  • Balance Sheet Snapshot

    Below shows the total assets, liabilities and book value per share for Biogen Inc. More…

    Total Assets Total Liabilities Book Value Per Share
    28.19k 13.71k 99.96
  • Balance Sheet (Yearly/ Quarterly)
  • Balance Sheet Supplement
  • Key Ratios Snapshot

    Some of the financial key ratios for Biogen Inc are shown below. More…

    3Y Rev Growth 3Y Operating Profit Growth Operating Margin
    -11.2% -34.2% 18.4%
    FCF Margin ROE ROA
    10.3% 7.9% 4.1%
  • Income Statement Ratios
  • Balance Sheet Ratios
  • Cash Flow Ratios
  • Valuation Ratios
  • Other Ratios
  • Other Supplementary Items
  • Analysis

    At GoodWhale, we have conducted a comprehensive analysis of the fundamentals of BIOGEN INC. Our Star Chart classification of BIOGEN INC as ‘elephant’ reveals that this company is rich in assets once liabilities have been deducted. This makes BIOGEN INC an attractive option for investors seeking out a secure investment with strong profitability and medium assets. Though the company is weak in dividend and growth, BIOGEN INC has a high health score of 8/10 with regard to its cashflows and debt, making it capable of safely riding out any crisis without the risk of bankruptcy. As such, investors looking for a secure investment with a strong return can look to invest in BIOGEN INC. More…

  • Star Chart Analysis
  • Valuation Analysis




  • Peers

    In the biotechnology industry, Biogen Inc is up against some stiff competition from the likes of Eli Lilly and Co, Gilead Sciences Inc, and Intra-Cellular Therapies Inc. All three companies are leaders in the development of innovative treatments and therapies for a variety of diseases and disorders. Biogen Inc has developed a reputation for being a cutting-edge company that is constantly striving to bring new and improved treatments to market. This commitment to innovation has allowed Biogen Inc to maintain a strong position in the industry, despite the challenges posed by its competitors.

    – Eli Lilly and Co ($NYSE:LLY)

    Eli Lilly and Co is a global pharmaceutical company that develops and markets prescription medicines and vaccines for various medical conditions. The company’s market cap as of 2022 is 316.18B. Its return on equity (ROE) is 45.88%.

    Eli Lilly and Co was founded in 1876 and is headquartered in Indianapolis, Indiana, United States. The company operates in more than 140 countries worldwide. Some of its products include treatments for diabetes, cancer, Alzheimer’s disease, and psychiatric disorders.

    – Gilead Sciences Inc ($NASDAQ:GILD)

    Gilead Sciences Inc is a research-based biopharmaceutical company that discovers, develops and commercialises innovative therapeutics. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead Sciences Inc has a market cap of 83.2B as of 2022 and a Return on Equity of 24.03%. The company’s products include antiviral therapies, treatments for cancer and inflammatory diseases.

    – Intra-Cellular Therapies Inc ($NASDAQ:ITCI)

    Intra-Cellular Therapies Inc is a clinical stage biopharmaceutical company that focuses on the development of drugs for the treatment of neuropsychiatric disorders. The company’s market cap as of 2022 was 4.47B, and its ROE was -42.76%. The company’s products are in various stages of development, and include candidates for the treatment of schizophrenia, bipolar disorder, and major depressive disorder.

    Summary

    Biogen Inc is a biotechnology company focused on the development of treatments for neurological and neurodegenerative diseases. The latest news surrounding the company is that its generic version of the multiple sclerosis drug Tecfidera, which was approved in Europe, has been revoked. This has caused a dip in the stock price of Biogen Inc. Investors should take into consideration the implications of this news and the effects it will have on the company’s finances. When assessing Biogen Inc as an investment, investors should take into account the current market share of the company, their competitive advantages, and any recent developments within the industry.

    Additionally, investors should review Biogen Inc’s financials to determine if it is a viable option for capital investment. Overall, investors should research Biogen Inc thoroughly before investing in order to make an informed decision.

    Recent Posts

    Leave a Comment