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New words:
AbbVie, Acorda, adapt, Argentinian, bankruptcy, BioPharma, BPCR, budgetary, built, cemdomespib, chemotherapy, climate, CODM, composition, cybersecurity, demonstrated, Denmark, Department, diabetic, dictate, diffuse, DOJ, elating, energy, entrance, extortion, fiscal, formulation, FUJIFILM, gas, GemOx, greenhouse, landscape, learning, LP, machine, maintenance, Master, monthly, neuropathic, newly, notified, pain, Partnership, Peso, PLC, prejudice, presidential, procedural, provisional, PRV, rapidly, recommending, reconcile, reconsidered, regain, repayment, rescheduled, role, rule, sizeable, stable, statistically, subpoena, Supreme, threat, title, understanding, VA, voluntarily, weighted, worsen, York
Removed:
aducanumab, Africa, amendment, Angelman, anniversary, annulled, arrangement, Asian, brain, CLE, closed, CMS, consisted, contusion, decided, declaration, developmental, discontinued, discontinuing, dose, DPN, duty, elimination, entirety, ERISA, establishing, expanding, exploring, favor, FDIC, filling, glibenclamide, glofitamab, hacking, hearing, House, incentivize, indirectly, inhibitor, initiation, insolvent, investigated, Korean, length, light, litifilimab, loading, modestly, mosunetuzumab, moving, NCD, negotiate, neurofilament, neuropsychiatry, observed, offsetting, pandemic, pausing, penalize, plasma, point, posed, prefer, prioritization, qualifying, realizable, rebuilding, receivership, redesign, redesigning, reflecting, reimbursing, reliant, remeasurement, remote, removing, represented, restriction, revalue, secondary, securing, shortage, Signature, spinocerebellar, split, strain, SVB, syndrome, terminating, TGN, threatened, transferring, translation, unit, verification, Veteran, vixotrigine, won
Financial report summary
?Competition
Spectrum Pharmaceuticals • Sarepta Therapeutics • Alexion Pharmaceuticals • Sangamo Therapeutics • X.T.L. Biopharmaceuticals • Seagen • Cytokinetics • Cassava Sciences • PTC Therapeutics • Alterity TherapeuticsRisks
- We are substantially dependent on revenue from our products.
- Our long-term success depends upon the successful development of new products and additional indications for our existing products.
- If we fail to compete effectively, our business and market position would suffer.
- Our business may be adversely affected if we do not successfully execute or realize the anticipated benefits of our strategic and growth initiatives.
- We depend on relationships with collaborators and other third-parties for revenue, and for the development, regulatory approval, commercialization and marketing of certain of our products and product candidates, which are outside of our full control.
- Our results of operations may be adversely affected by current and potential future healthcare reforms.
- Our success in commercializing biosimilars is subject to risks and uncertainties inherent in the development, manufacture and commercialization of biosimilars. If we are unsuccessful in such activities, our business may be adversely affected.
- If we are unable to obtain and maintain adequate protection for our data, intellectual property and other proprietary rights, our business may be harmed.
- Successful preclinical work or early stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product.
- Clinical trials and the development of biopharmaceutical products is a lengthy and complex process. If we fail to adequately manage our clinical activities, our clinical trials or potential regulatory approvals may be delayed or denied.
- Adverse safety events or restrictions on use and safety warnings for our products can negatively affect our business, product sales and stock price.
- A breakdown or breach of our information systems could subject us to liability or interrupt the operation of our business.
- Manufacturing issues could substantially increase our costs, limit supply of our products and/or reduce our revenue.
- Management, personnel and other organizational changes may disrupt our operations, and we may have difficulty retaining personnel or attracting and retaining qualified replacements on a timely basis for the management and other personnel who may leave the Company.
- If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business.
- Our sales and operations are subject to the risks of doing business internationally.
- We built a large-scale biologics manufacturing facility and are building a gene therapy manufacturing facility, which will result in the incurrence of significant investment with no assurance that such investment will be recouped.
- The illegal distribution and sale by third-parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.
- The increasing use of social media platforms and artificial intelligence based software presents new risks and challenges.
- Our operating results are subject to significant fluctuations.
- Our investments in properties may not be fully realized.
- We may not be able to access the capital and credit markets on terms that are favorable to us.
- Our indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business.
- Our investment portfolio is subject to market, interest and credit risk that may reduce its value.
- There can be no assurance that we will continue to repurchase shares or that we will repurchase shares at favorable prices.
- Some of our collaboration agreements contain change in control provisions that may discourage a third-party from attempting to acquire us.
- Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
- Our business involves environmental risks, which include the cost of compliance and the risk of contamination or injury.
Management Discussion
- •discontinuation of BIIB135 for the treatment of MS.
- •development of BIIB080 for the treatment of Alzheimer's disease.