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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
volatility.
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
operations.
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.
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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
parties.
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
volatility.
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