United states securities and exchange commission

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Violations of governmental regulation may be punishable by criminal and civil sanctions against us, including 
fines and civil monetary penalties and exclusion from participation in government programs, including Medicare and 
Medicaid, as well as against executives overseeing our business. In addition to penalties for violation of laws and 
regulations, we could be required to repay amounts we received from government payors, or pay additional rebates 
and interest if we are found to have miscalculated the pricing information we have submitted to the government. We 
cannot ensure you that our compliance controls, policies and procedures will in every instance protect us from acts 
committed by our employees, collaborators, partners or third-party providers that would violate the laws or 
regulations of the jurisdictions in which we operate. Whether or not we have complied with the law, an investigation 
into alleged unlawful conduct could increase our expenses, damage our reputation, divert management time and 
attention and/or adversely affect our business.
Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
As a global biopharmaceutical company, we are subject to taxation in numerous countries, states and other 
jurisdictions.  As a result, our effective tax rate is derived from a combination of applicable tax rates in the various 
places that we operate. In preparing our financial statements, we estimate the amount of tax that will become 
payable in each of such places. Our effective tax rate, however, may be different than experienced in the past due to 
numerous factors, including changes in the mix of our profitability from country to country, the results of 
examinations and audits of our tax filings, adjustments to the value of our uncertain tax positions, changes in 
accounting for income taxes and changes in tax laws, including the 2017 Tax Act. Any of these factors could cause 
us to experience an effective tax rate significantly different from previous periods or our current expectations.
In addition, our inability to secure or sustain acceptable arrangements with tax authorities and future changes 
in the tax laws, among other things, may result in tax obligations in excess of amounts accrued in our financial 
statements.
The 2017 Tax Act has resulted in significant changes to the U.S. corporate income tax system. These changes 
include a federal statutory rate reduction from 35% to 21%, the elimination or reduction of certain domestic 
deductions and credits and limitations on the deductibility of interest expense and executive compensation. The 
2017 Tax Act also transitions international taxation from a worldwide system to a modified territorial system and 
includes base erosion prevention measures on non-U.S. earnings, which has the effect of subjecting certain earnings 
of our foreign subsidiaries to U.S. taxation as GILTI. These changes are effective beginning in 2018.
The 2017 Tax Act also includes the Transition Toll Tax, which is a one-time mandatory deemed repatriation tax 
on accumulated foreign subsidiaries' previously untaxed foreign earnings. The Transition Toll Tax will be paid over an 
eight-year period, starting in 2018, and will not accrue interest. 
Our preliminary estimate of the Transition Toll Tax and the remeasurement of our deferred tax assets and 
liabilities is subject to the finalization of management's analysis related to certain matters, such as developing 
interpretations of the provisions of the 2017 Tax Act, changes to certain estimates and amounts related to the 
earnings and profits of certain subsidiaries and the filing of our tax returns. U.S. Treasury regulations, administrative 
interpretations or court decisions interpreting the 2017 Tax Act may require further adjustments and changes in our 
estimates, which could have a material adverse effect on our business, results of operations or financial conditions. 
The final determination of the Transition Toll Tax and the remeasurement of our deferred tax assets and liabilities will 
be completed as additional information becomes available, but no later than one year from the enactment of the 
2017 Tax Act.
In addition, the adoption of some or all of the recommendations set forth in the Organization for Economic Co-
operation and Development’s project on “Base Erosion and Profit Shifting” (BEPS) by tax authorities in the countries 
in which we operate, could negatively impact our effective tax rate. These recommendations focus on payments from 
affiliates in high tax jurisdictions to affiliates in lower tax jurisdictions and the activities that give rise to a taxable 
presence in a particular country.
Our sales and operations are subject to the risks of doing business internationally.
We are increasing our presence in international markets, particularly emerging markets, subjecting us to many 
risks that could adversely affect our business and revenues, such as:
•  the inability to obtain necessary foreign regulatory or pricing approvals of products in a timely manner; 
•  uncertainties regarding the collectability of accounts receivable; 
•  fluctuations in foreign currency exchange rates that may adversely impact our revenues and net income; 

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•  difficulties in staffing and managing international operations; 
•  the imposition of governmental controls; 
•  less favorable intellectual property or other applicable laws; 
•  increasingly complex standards for complying with foreign laws and regulations that may differ substantially 
from country to country and may conflict with corresponding U.S. laws and regulations; 
•  the far-reaching anti-bribery and anti-corruption legislation in the U.K., including the Bribery Act, and elsewhere 
and escalation of investigations and prosecutions pursuant to such laws; 
•  the effects of the implementation of the U.K.’s decision to voluntarily depart from the E.U., known as Brexit;
•  compliance with complex import and export control laws;
•  restrictions on direct investments by foreign entities and trade restrictions; 
•  greater political or economic instability; and 
•  changes in tax laws and tariffs.
In addition, our international operations are subject to regulation under U.S. law. For example, the FCPA 
prohibits U.S. companies and their representatives from paying, offering to pay, promising to pay or authorizing the 
payment of anything of value to any foreign government official, government staff member, political party or political 
candidate for the purpose of obtaining or retaining business or to otherwise obtain favorable treatment or influence a 
person working in an official capacity. In many countries, the health care professionals we regularly interact with may 
meet the FCPA's definition of a foreign government official. Failure to comply with domestic or foreign laws could 
result in various adverse consequences, including: possible delay in approval or refusal to approve a product; recalls, 
seizures or withdrawal of an approved product from the market; disruption in the supply or availability of our products 
or suspension of export or import privileges; the imposition of civil or criminal sanctions; the prosecution of 
executives overseeing our international operations; and damage to our reputation. Any significant impairment of our 
ability to sell products outside of the U.S. could adversely impact our business and financial results.
Our operating results are subject to significant fluctuations.
Our quarterly revenues, expenses and net income (loss) have fluctuated in the past and are likely to fluctuate 
significantly in the future due to the risks described in these “Risk Factors” as well as the timing of charges and 
expenses that we may take. We have recorded, or may be required to record, charges that include:
•  the cost of restructurings or other initiatives to streamline our operations and reallocate resources; 
•  impairments with respect to investments, fixed assets and long-lived assets, including in-process R&D and 
other intangible assets; 
•  inventory write-downs for failed quality specifications, charges for excess or obsolete inventory and charges for 
inventory write downs relating to product suspensions, expirations or recalls; 
•  changes in the fair value of contingent consideration;
•  bad debt expenses and increased bad debt reserves; 
•  outcomes of litigation and other legal or administrative proceedings, regulatory matters and tax matters;
•  milestone payments under license and collaboration agreements; and 
•  payments in connection with acquisitions and other business development activities.

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