Congressional Inquiry Accuses FDA and Biogen of Improper Collaboration on 2021 Approval of Aduhelm Alzheimer’s Treatment
December 30, 2022
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Biogen Inc ($NASDAQ:BIIB). is an American biotechnology company based in Cambridge, Massachusetts. It is a global leader in the development of treatments and cures for neurological diseases such as Alzheimer’s, multiple sclerosis, and Parkinson’s disease. It has a long-standing history of innovation and collaboration with regulatory agencies such as the U.S. Food and Drug Administration (FDA). Recently, however, a congressional inquiry has accused the FDA and Biogen of improper collaboration on the approval of Aduhelm, the first U.S.-sanctioned Alzheimer’s treatment in nearly two decades, in 2021. The inquiry follows reports of Biotin’s alleged “off-label” use of its own products in clinical trials and data manipulation. Biogen has denied any wrongdoing in connection with the Aduhelm approval process.
The FDA has also come under fire for its rushed decision to approve Aduhelm without sufficient evidence of its effectiveness. The agency has defended its decision and cited a “compelling need” for an Alzheimer’s treatment, given the limited number of disease-modifying therapies available. The congressional inquiry is intended to shed light on whether the agency granted preferential treatment to Biogen due to its ties to the company. The inquiry could potentially lead to changes in the way drug approvals are regulated, as well as sanctions against Biogen or the FDA if any wrongdoing is found.
Stock Price
The accusations have been met with mostly positive sentiments, as investors believe it could lead to an increase in Biogen Inc.’s stock value. On Thursday, BIOGEN INC stock opened at $274.8 and closed at $276.0, up by 0.7% from last closing price of 274.0. Analyst predictions suggest that Biogen Inc. is likely to see more growth in the near future due to the FDA approval for Aduhelm and the news surrounding this congressional inquiry. As the inquiry continues, it will be important to keep an eye on Biogen Inc.’s stock performance to determine how this will affect the company’s overall value.
Additionally, if the inquiry finds that there was indeed improper collaboration between the FDA and Biogen Inc., this could have serious repercussions for both parties involved. For now, investors are optimistic that the news will only lead to continued growth for Biogen Inc., but only time will tell how the inquiry will ultimately affect the company. Live Quote…
About the Company
Income Snapshot
Below shows the total revenue, net income and net margin for Biogen Inc. More…
| Total Revenues | Net Income | Net Margin |
| 10.36k | 2.86k | 23.1% |
Cash Flow Snapshot
Below shows the cash from operations, investing and financing for Biogen Inc. More…
| Operations | Investing | Financing |
| 2.4k | 1.6k | -1.73k |
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 |
| 24.85k | 12.09k | 88.72 |
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 |
| -10.0% | -24.3% | 35.2% |
| FCF Margin | ROE | ROA |
| 21.0% | 18.5% | 9.2% |
VI Analysis
Company fundamentals are essential when evaluating a company’s long term potential. The Visual Intelligence (VI) app makes the analysis of a company’s fundamentals easy by providing a simple overview. The VI Star Chart for BIOGEN INC shows that the company is strong in profitability and medium in asset quality, but weak in dividend and growth. BIOGEN INC is classified as an ‘elephant’, meaning it has a high asset-to-liability ratio. This type of company may be of interest to investors looking for a reliable, long-term investment. Furthermore, BIOGEN INC has a high health score of 10/10, indicating that its cashflow and debt are healthy and that the company is capable of riding out any crisis without fear of bankruptcy. Overall, BIOGEN INC is a strong contender for investors looking for a long-term, reliable investment. Its strong fundamentals, high health score, and classification as an ‘elephant’ make it an attractive option for those interested in making a safe and secure investment. More…
VI 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 that specializes in treatments for neurological diseases, primarily Alzheimer’s. Investors should consider the company’s stock as an attractive investment opportunity due to its 2021 approval of Aduhelm, a new Alzheimer’s treatment, by the Food and Drug Administration (FDA). Recent congressional inquiries have raised questions about the FDA’s collaboration with Biogen on the drug’s approval, but investor sentiment has remained mostly positive. Biogen also has a strong pipeline of potential new treatments and has seen success in its current therapies.
The company boasts a strong balance sheet and has a reliable dividend pay-out policy. With its focus on neurological diseases, strong financials, and promising new therapies, Biogen looks like a good long-term investment for investors.
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