United states securities and exchange commission

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Table of Contents
Item  1A.  
Risk Factors
We are substantially dependent on revenues from our principal products. 
Our current revenues depend upon continued sales of our principal products, and, unless we develop or acquire 
rights to new products and technologies, we will be substantially dependent on sales from our principal products for 
many years. Further, following the completion of the spin-off of our hemophilia business, our revenues are further 
reliant and concentrated on sales of our MS products in an increasingly competitive market, and revenues from 
sales of our product for SMA. Any of the following negative developments relating to any of our principal products 
may adversely affect our revenues and results of operations or could cause a decline in our stock price: 
•  safety or efficacy issues; 
•  the introduction or greater acceptance of competing products, including lower-priced competing products
•  constraints and additional pressures on product pricing or price increases, including those resulting from 
governmental or regulatory requirements, increased competition or changes in, or implementation of, 
reimbursement policies and practices of payors and other third parties; or 
•  adverse legal, administrative, regulatory or legislative developments.
SPINRAZA has been approved by, among others, the FDA, the EC and the Japanese Ministry of Health, Labor 
and Welfare, and is in the early stages of commercial launch in these and other markets. In addition to risks 
associated with new product launches and the other factors described in these “Risk Factors,” our ability to 
successfully commercialize SPINRAZA may be adversely affected due to:
•  our limited marketing experience within the SMA market, which may impact our ability to develop relationships 
with the associated medical and scientific community
•  the lack of readiness of healthcare providers to treat patients with SMA;
•  the effectiveness of our commercial strategy for marketing SPINRAZA; and
•  our ability to maintain a positive reputation among patients, healthcare providers and others in the SMA 
community, which may be impacted by pricing and reimbursement decisions relating to SPINRAZA. 
If we fail to compete effectively, our business and market position would suffer.
The biopharmaceutical industry and the markets in which we operate are intensely competitive. We compete in 
the marketing and sale of our products, the development of new products and processes, the acquisition of rights to 
new products with commercial potential and the hiring and retention of personnel. We compete with biotechnology 
and pharmaceutical companies that have a greater number of products on the market and in the product pipeline, 
greater financial and other resources and other technological or competitive advantages. One or more of our 
competitors may benefit from significantly greater sales and marketing capabilities, may develop products that are 
accepted more widely than ours or may receive patent protection that dominates, blocks or adversely affects our 
product development or business.
Our products are also susceptible to increasing competition from generics and biosimilars in many 
markets. Generic versions of drugs and biosimilars are likely to be sold at substantially lower prices than branded 
products. Accordingly, the introduction of generic or biosimilar versions of our marketed products, as well as lower-
priced competing products, likely would significantly reduce both the price that we receive for such marketed 
products and the volume of products that we sell, which may have an adverse impact on our results of operations.
In the MS market, we face intense competition as the number of products and competitors continues to 
expand. Due to our significant reliance on sales of our MS products, our business may be harmed if we are unable 
to successfully compete in the MS market. More specifically, our ability to compete, maintain and grow our share in 
the MS market may be adversely affected due to a number of factors, including:
•  the introduction of more efficacious, safer, less expensive or more convenient alternatives to our MS products, 
including our own products and products of our collaborators; 
•  the introduction of lower-cost biosimilars, follow-on products or generic versions of branded MS products sold 
by our competitors, and the possibility of future competition from generic versions or prodrugs of existing 
therapeutics or from off-label use by physicians of therapies indicated for other conditions to treat MS patients; 

Table of Contents
•  patient dynamics, including the size of the patient population and our ability to attract new patients to our 
•  damage to physician and patient confidence in any of our MS products or to our sales and reputation as a 
result of label changes or adverse experiences or events that may occur with patients treated with our MS 
•  inability to obtain appropriate pricing and reimbursement for our MS products compared to our competitors in 
key international markets; or 
•  our ability to obtain and maintain patent, data or market exclusivity for our MS products.
Sales of our products depend, to a significant extent, on adequate coverage, pricing and reimbursement from third-
party payors, which are subject to increasing and intense pressure from political, social, competitive and other sources. 
Our inability to maintain adequate coverage, or a reduction in pricing or reimbursement, could have an adverse effect 
on our business, revenues and results of operations and could cause a decline in our stock price.
Sales of our products are dependent, in large part, on the availability and extent of coverage, pricing and 
reimbursement from government health administration authorities, private health insurers and other organizations. 
When a new pharmaceutical product is approved, the availability of government and private reimbursement for that 
product may be uncertain, as is the pricing and amount for which that product will be reimbursed. 
Pricing and reimbursement for our products may be adversely affected by a number of factors, including: 
•  changes in, and implementation of, federal, state or foreign government regulations or private third-party 
payors’ reimbursement policies; 
•  pressure by employers on private health insurance plans to reduce costs;
•  consolidation and increasing assertiveness of payors, including managed care organizations, health insurers, 
pharmacy benefit managers, government health administration authorities, private health insurers and other 
organizations, seeking price discounts or rebates in connection with the placement of our products on their 
formularies and, in some cases, the imposition of restrictions on access or coverage of particular drugs or 
pricing determined based on perceived value; and
•  our value-based contracting pilot program pursuant to which we aim to tie the pricing of our products to their 
clinical values by either aligning price to patient outcomes or adjusting price for patients who discontinue 
therapy for any reason, including efficacy or tolerability concerns.
Our ability to set the price for our products varies significantly from country to country and as a result so can 
the price of our products. Certain countries set prices by reference to the prices in other countries where our 
products are marketed. Thus, our inability to secure favorable prices in a particular country may not only limit the 
revenues from our products within that country, but may also adversely affect our ability to obtain acceptable prices 
in other markets. This may create the opportunity for third-party cross-border trade or influence our decision to sell 
or not to sell a product, thus adversely affecting our geographic expansion plans and revenues.
Our failure to maintain adequate coverage, pricing or reimbursement for our products would have an adverse 
effect on our business, revenues and results of operations, could curtail or eliminate our ability to adequately fund 
research and development programs for the discovery and commercialization of new products and could cause a 
decline in our stock price.
Drug prices are under significant scrutiny in the markets in which our products are prescribed. We expect drug 
pricing and other health care costs to continue to be subject to intense political and societal pressures on a global 
basis. In addition, competition from current and future competitors may negatively impact our ability to maintain 
pricing and our market share. New products or treatments brought to market by our competitors could cause 
revenues for our products to decrease due to potential price reductions and lower sales volumes. As a result, our 
business and reputation may be harmed, our stock price may be adversely impacted and experience periods of 
volatility, and our results of operations may be adversely impacted.  

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