United states securities and exchange commission

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Table of Contents
Adverse safety events or restrictions on use and safety warnings for our products can negatively affect our business, 
product sales and stock price.
Adverse safety events involving our marketed products may have a negative impact on our business. Discovery 
of safety issues with our products could create product liability and could cause additional regulatory scrutiny and 
requirements for additional labeling or safety monitoring, withdrawal of products from the market and the imposition 
of fines or criminal penalties. Adverse safety events may also damage physician, patient and/or investor confidence 
in our products and our reputation. Any of these could result in liabilities, loss of revenues, material write-offs of 
inventory, material impairments of intangible assets, goodwill and fixed assets, material restructuring charges and 
other adverse impacts on our results of operations. 
Regulatory authorities are making greater amounts of stand-alone safety information directly available to the 
public through periodic safety update reports, patient registries and other reporting requirements. The reporting of 
adverse safety events involving our products or products similar to ours and public rumors about such events may 
increase claims against us and may also cause our product sales or stock price to decline or experience periods of 
Restrictions on use or significant safety warnings that may be required to be included in the label of our 
products, such as the risk of developing progressive multifocal leukoencephalopathy, a serious brain infection, or 
liver injury in the label for certain of our products, may significantly reduce expected revenues for those products and 
require significant expense and management time. 
If we are unable to obtain and maintain adequate protection for our data, intellectual property and other proprietary 
rights, our business may be harmed. 
Our success depends in part on our ability to obtain and defend patent and other intellectual property rights 
that are important to the commercialization of our products and product candidates. The degree of patent protection 
that will be afforded to our products and processes in the U.S. and in other important markets remains uncertain 
and is dependent upon the scope of protection decided upon by the patent offices, courts, administrative bodies and 
lawmakers in these countries. We can provide no assurance that we will successfully obtain or preserve patent 
protection for the technologies incorporated into our products and processes, or that the protection obtained will be 
of sufficient breadth and degree to protect our commercial interests in all countries where we conduct business. If 
we cannot prevent others from exploiting our inventions, we will not derive the benefit from them that we currently 
expect. Furthermore, we can provide no assurance that our products will not infringe patents or other intellectual 
property rights held by third parties.
We also rely on regulatory exclusivity for protection of our products. Implementation and enforcement of 
regulatory exclusivity, which may consist of regulatory data protection and market protection, varies widely from 
country to country. Failure to qualify for regulatory exclusivity, or failure to obtain or maintain the extent or duration of 
such protections that we expect in each of the markets for our products due to challenges, changes or 
interpretations in the law or otherwise, could affect our revenues for our products or our decision on whether to 
market our products in a particular country or countries or could otherwise have an adverse impact on our results of 
Litigation, interferences, oppositions, inter partes reviews, administrative challenges or other similar types of 
proceedings are, have been and may in the future be necessary in some instances to determine the validity and 
scope of certain of our proprietary rights, and in other instances to determine the validity, scope or non-infringement 
of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. We 
may also face challenges to our patent and regulatory protections covering our products by third parties, including 
manufacturers of generics and biosimilars that may choose to launch or attempt to launch their products before the 
expiration of our patent or regulatory exclusivity. Litigation, interference, oppositions, inter partes reviews, 
administrative challenges or other similar types of proceedings are unpredictable and may be protracted, expensive 
and distracting to management. The outcome of such proceedings could adversely affect the validity and scope of 
our patent or other proprietary rights, hinder our ability to manufacture and market our products, require us to seek a 
license for the infringed product or technology or result in the assessment of significant monetary damages against 
us that may exceed amounts, if any, accrued in our financial statements. An adverse determination in a judicial or 
administrative proceeding or a failure to obtain necessary licenses could prevent us from manufacturing or selling 
our products. Furthermore, payments under any licenses that we are able to obtain would reduce our profits derived 
from the covered products and services.

Table of Contents
Our long-term success depends upon the successful development of new products and additional indications for 
existing products. 
Our long-term viability and growth will depend upon successful development of additional indications for our 
existing products as well as successful development of new products and technologies from our research and 
development activities, our biosimilars joint venture with Samsung Biologics or licenses or acquisitions from third 
Product development is very expensive and involves a high degree of risk. Only a small number of research and 
development programs result in the commercialization of a product. Clinical trials may indicate that our product 
candidates lack efficacy, have harmful side effects, result in unexpected adverse events or raise other concerns that 
may significantly reduce the likelihood of regulatory approval. This may result in terminated programs, significant 
restrictions on use and safety warnings in an approved label, adverse placement within the treatment paradigm or 
significant reduction in the commercial potential of the product candidate.
Successful preclinical work or early stage clinical trials does not ensure success in later stage trials, regulatory 
approval or commercial viability of a product.
Positive results in a trial may not be replicated in subsequent or confirmatory trials. Additionally, success in 
preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be 
successful or that regulatory approval will be obtained. In addition, even if later stage clinical trials are successful, 
regulatory authorities may delay or decline approval of our product candidates. Regulatory authorities may disagree 
with our view of the data, require additional studies or disagree with our trial design or endpoints. Regulatory 
authorities may also fail to approve the facilities or the processes used to manufacture a product candidate, our 
dosing or delivery methods or companion devices. Regulatory authorities may grant marketing approval that is more 
restricted than anticipated. These restrictions may include limiting indications to narrow patient populations and the 
imposition of safety monitoring, educational requirements and risk evaluation and mitigation strategies. The 
occurrence of any of these events could result in significant costs and expenses, have an adverse effect on our 
business, financial condition and results of operations and cause our stock price to decline or experience periods of 
Even if we are able to successfully develop new products or indications, sales of new products or products with 
additional indications may not meet investor expectations. We may also make a strategic decision to discontinue 
development of a product or indication if, for example, we believe commercialization will be difficult relative to the 
standard of care or other opportunities in our pipeline.
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. 
Conducting clinical trials is a complex, time-consuming and expensive process. Our ability to complete clinical 
trials in a timely fashion depends in large part on a number of key factors. These factors include protocol design, 
regulatory and institutional review board approval, patient enrollment rates and compliance with cGCP. If we or our 
third-party clinical trial providers or third-party CROs do not successfully carry out these clinical activities, our clinical 
trials or the potential regulatory approval of a product candidate may be delayed or be unsuccessful.
We have opened clinical sites and are enrolling patients in a number of countries where our experience is 
limited. In most cases, we use the services of third parties to carry out our clinical trial related activities and rely on 
such parties to accurately report their results. Our reliance on third parties for these activities may impact our ability 
to control the timing, conduct, expense and quality of our clinical trials. One CRO has responsibility for a substantial 
portion of our clinical trial related activities and reporting. If this CRO does not adequately perform, many of our trials 
may be affected. We may need to replace our CROs. Although we believe there are a number of other CROs we could 
engage to continue these activities, the replacement of an existing CRO may result in the delay of the affected trials 
or otherwise adversely affect our efforts to obtain regulatory approvals and commercialize our product candidates.
Our results of operations may be adversely affected by current and potential future healthcare reforms.
In the U.S., federal and state legislatures, health agencies and third-party payors continue to focus on 
containing the cost of health care. Legislative and regulatory proposals, enactments to reform health care insurance 
programs and increasing pressure from social sources could significantly influence the manner in which our products 
are prescribed and purchased. For example, provisions of the PPACA have resulted in changes in the way health care 
is paid for by both governmental and private insurers, including increased rebates owed by manufacturers under the 
Medicaid Drug Rebate Program, annual fees and taxes on manufacturers of certain branded prescription drugs, the 
requirement that manufacturers participate in a discount program for certain outpatient drugs under Medicare Part D 

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