Biogen Inc is one of the world’s first global biotechnology companies specializing in discovering, developing, and delivering innovative therapies to their international patients to treat various neurological and neurodegenerative diseases.
Biogen has a strong desire to focus on medical breakthroughs for neuroscience. With their scientific expertise, they are risk-takers and leaders in researching and developing medicines for neuroscience, which benefits society.
About Biogen
Biogen was founded in 1978 in Geneva and is now based in Cambridge, Massachusetts. They merged with IDEC Pharmaceuticals in 2003, which made them become the third-largest biotechnology company globally. Their mission is clear – they are pioneers in neuroscience.
Biogen has the following portfolio in the biotech industry:
- A leading portfolio of medications to treat multiple sclerosis (MS)
- Commercializes biosimilars of advanced biologics
- Has presented the first approved treatment for spinal muscular atrophy
The company has a focus on advancing research programs in the following:
- MS and neuroimmunology
- Neuromuscular disorders
- Alzheimer’s disease and dementia
- Ophthalmology
- Movement disorders
- Neuropathic pain
- Immunology
- Neuropsychiatry
- Neurology
Biogen and Eisai joined forces in 2014 to develop two of their Alzheimer’s disease candidates together. Each one had the potential to reduce Aβ plaques formed in the brain. They also slow down new plaques from forming, with the possibility to improve symptoms amongst their patients and curb the progression of the disease.
Biogen Acquisitions Timeline
2006
- Biogen acquired Conforma Therapeutics, a cancer specialist, for $250 million. After that, they acquired Fumapharm AG and consolidated Fumaderm and BG-12, which is currently being studied to treat psoriasis and multiple sclerosis.
2007
- Biogen acquired Syntonix Pharmaceuticals for up to $120 million. The acquisition allowed them to get Syntonix’s technology for inhalation treatments and their main product for hemophilia B.
- Biogen bought the rights of the Alzheimer’s disease drug Aducanumab for $200 billion.
2013
- Biogen paid $3.25 billion to Elan for the full rights to Tysabri, which gets used in the treatment of multiple sclerosis.
2015
- Biogen acquired Convergence Pharmaceuticals for about $675 million. The acquisition was to accelerate the development of CNV1014802, a small molecule sodium channel blocking candidate in its second phase.
2019
- Biogen acquired Nightstar Therapeutics for $800 million, at $25.50 per share. Nightstar Therapeutics focuses on inherited retinal disorders.
2020
- Biogen acquired a $650 million stake in Sage Therapeutics with an upfront payment of $875 million to jointly develop treatments for depression.
Aducanumab – Alzheimer’s Disease Drug
Biogen first stopped its Phase 3 trials for Aducanumab, an Alzheimer’s disease drug, due to analysis showing they won’t reach their endpoint. Biogen then changed their minds and announced they would apply for US FDA approval for the drug.
In 2020, the FDA voted against approving the drug, but in June 2021, it got approved. It is the first time since 2003 that the FDA has approved a drug for treating Alzheimer’s disease. Due to the accelerated approval, Biogen will need to conduct a post-approval phase 4 clinical trial to get its clinical benefit verified for continued approval. It has been revealed that the drug will get marketed under the name Aduhelm.
In a statement released by CEO Michel Vounatsos, he said:
“This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.“
Vounatsos announced they would not increase the medication’s price for the next four years and are satisfied with the $56,000 annual list price. Vounatsos further declared Biogen would work closely with private insurers and Medicare. However, this could cost Medicare around $100 billion a year to cover treatment. Vounatsos has also stated that Alzheimer’s disease and other forms of dementia are already costing the US over $600 million a year and annually costs patients $500,000.
Vounatsos had said that Biogen would continue gathering data and been given nine years by the FDA to prove Aduhelm’s efficacy.
The Institute of Clinical and Economic Review (ICER) thinks the drug is worth $8,000 a year. They believe the announced pricing of $56,000 is better merited to a drug that would entirely halt dementia, and Aducanumab is not that effective.
The government is now looking for a way to satisfy patients who need the help, even though scientists believe the drug doesn’t have sufficient evidence for its effectiveness. Policy experts also have warned that it will become a financial issue for Medicare in the future.
It is still unknown what out-of-pocket costs patients will have to pay for treatment, but it will depend on their health coverage.
Aducanumab is expected to generate billions of dollars in revenue for Biogen, offering a new sense of hope for affected patients and their families. Biogen will get to sell its approved drug over several years, with potential annual sales forecasted to reach between $10 billion to $50 billion, until they can complete the required clinical study.
Along with the Alzheimer’s disease drug, Vounatsos said Biogen has three additional compounds in development that could potentially get used in various diseases.
About Alzheimer’s Disease
Alzheimer’s disease is a developing neurodegenerative disorder that destroys thinking skills and memory slowly. According to the Alzheimer’s Association, more than 6 million Americans live with the disease, and the overall number is expected to rise to nearly 13 million by 2050. Alzheimer’s disease is also the 6th leading cause of death in the United States.
Experts Resign from the FDA Advisory Committee
There have been three resignations from the FDA’s advisory committee since the FDA approved Aduhelm against nearly every panel member’s wishes. One of the resignees, Dr. Aaron Kesselheim, a professor at Harvard, had been on the advisory committee since 2015. He stated that the FDA had given the committee members different criteria to consider than the cited ones used by the FDA in its decision.
He stated that “some of the questions FDA asked the Committee to answer were worded in a way that seemed slanted to yield responses that would favor the drug’s approval.“
The FDA has acknowledged the controversial attention the drug’s approval has gained and feels the benefits of Aduhelm far outweigh the therapy risks.
Due to the three resignations, the advisory committee has lost a third of its members who are not part of the government.
What the FDA Approval Means for Other Biotech Companies
Other biotech companies, such as Cassava Sciences, believe the FDA approval could push others to continue working on Alzheimer’s drugs. Cassava’s CEO, Remi Barbier, strongly believes “a Biogen approval is a win for the entire industry.“
The approval of Aducanumab can also be influential for Biogen’s late-stage Alzheimer’s drug, BAN2401), which is developing in collaboration with Japan’s Eisai.
Biogen Annual Financial Report – 2020
Biogen released its annual financial report for 2020, with the following reported:
- Full-year GAAP diluted earnings per share were $24.80
- Non-GAAP diluted earnings per share were $33.70
- Revenue generated was $13.4 billion, a 6% decrease from 2019
- Multiple sclerosis (MS) produced product revenue of $2.86 billion in the US in the first half of 2020
- MS product revenue in the US in the second half of 2020 was $2.25 billion
- Net cash flow of $4.2 billion was generated from operations, and free cash flow of $3.8 billion
- $6.7 billion returned to stockholders through repurchases throughout the year
- Ended 2020 with $3.4 billion in cash equivalents, cash, and marketable securities
Biogen (NASDAQ: BIIB) Stock
Biogen stock is a component of multiple stock indices, including:
- S&P 500
- S&P 100
- S&P 1500
- NASDAQ-100
Biogen is listed on the NASDAQ stock exchange and does not pay a dividend, therefore not offering a DRIP. As of June 11, 2021, Biogen stock was trading at $396.64.
Biogen Stock After the FDA Approval of Aducanumab
Before the FDA’s announcement, trading in the biotech stock got halted. However, Biogen’s shares surged by more than 60% after trading got reinstated before giving up some of the gains.
Goldman Sachs is projecting sales of $12 billion for the sales of Aduhelm, while others are less optimistic but still bullish. The sales of Aduhelm will rely primarily on how physicians are accepting of the drug.
For doctors to prescribe Aduhelm, patients will need to get a spinal tap or brain image scan to determine the presence of amyloid plaque. Patients will possibly need to cover these expenses as not all insurance companies cover them.
Some doctors are refusing to prescribe the drug to their patients due to Biogen’s clinical results. But, to determine if doctors are accepting, shareholders will need to keep track of these first quarters.
Some analysts predict Biogen stock prices to improve over the foreseeable future, as there will be a demand for Aduhelm, and it will get used, no matter what.
The Way Forward for Alzheimer’s Disease Drugs
Biogen is at the forefront of neuroscience. While still at an early stage of the trial phase, Biogen has results that can possibly change the lives of millions.
Defending its decision, the FDA believes that Biogen has submitted strong evidence that Aduhelm removed beta-amyloid from Alzheimer’s disease sufferers’ brains. The FDA’s Center for Drug Evaluation and Research director, Dr. Patrizia Cavazzoni, said they couldn’t tell what the path is like for other Alzheimer’s drugs or other neurodegenerative diseases.
However, patient advocates have welcomed the FDA’s decision, as it will revive research in the field and ignite further investment by several companies in disease-modifying therapies and treatments.