United states securities and exchange commission

Table of Contents
90
annual interest expense by approximately 
$6.8 million. 
Pricing Pressure
Governments in some international markets in 
which we operate have implemented measures aimed 
at reducing healthcare costs to limit the overall level 
of government expenditures. These measures vary by 
country and may include, among other things, patient 
access restrictions, suspensions on price increases, 
prospective and possibly retroactive price reductions 
and other recoupments and increased mandatory 
discounts or rebates, recoveries of past price 
increases and greater importation of drugs from 
lower-cost countries. 
In addition, 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 impair our 
ability to obtain acceptable prices in existing and 
potential new markets, which may limit market growth. 
The continued implementation of pricing actions 
throughout Europe may also lead to higher levels of 
parallel trade.
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. It is possible that additional federal health 
care reform measures will be adopted in the future, 
which could result in increased pricing pressure and 
reduced reimbursement for our products and 
otherwise have an adverse impact on our 
consolidated financial position or results of 
operations.
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 consolidated results of operations.
There is also significant economic pressure on 
state budgets that results in states increasingly 
seeking to achieve budget savings through 
mechanisms that limit coverage or payment for our 
drugs. Managed care organizations are also 
continuing to seek price discounts and, in some 
cases, to impose restrictions on the coverage of 
particular drugs.
Credit Risk
We are subject to credit risk from our accounts 
receivable related to our product sales. The majority 
of our accounts receivable arise from product sales in 
the U.S. and Europe with concentrations of credit risk 
limited due to the wide variety of customers and 
markets using our products, as well as their 
dispersion across many different geographic areas. 
Our accounts receivable are primarily due from 
wholesale distributors, public hospitals and other 
government entities. We monitor the financial 
performance and creditworthiness of our customers 
so that we can properly assess and respond to 
changes in their credit profile. We operate in certain 
countries where weakness in economic conditions 
can result in extended collection periods. We continue 
to monitor these conditions, including the volatility 
associated with international economies and the 
relevant financial markets, and assess their possible 
impact on our business. To date, we have not 
experienced any significant losses with respect to the 
collection of our accounts receivable. 
Credit and economic conditions in the E.U. 
continue to remain uncertain, which has, from time to 
time, led to long collection periods for our accounts 
receivable and greater collection risk in certain 
countries. 
We believe that our allowance for doubtful 
accounts was adequate as of December 31, 2017 
and 2016. However, if significant changes occur in the 
availability of government funding or the 
reimbursement practices of these or other 
governments, we may not be able to collect on 
amounts due to us from customers in such countries 
and our results of operations could be adversely 
affected.
Item 8.     
Financial Statements and 
Supplementary Data
The information required by this Item 8 is 
contained on pages F-1 through F-78 of this report 
and is incorporated herein by reference.
Item 9.     
Changes in and Disagreements 
with Accountants on Accounting and 
Financial Disclosure
None.

---

Table of Contents
91
Item 9A.      Controls and Procedures
Disclosure Controls and Procedures and 
Internal Control over Financial Reporting
Controls and Procedures
We have carried out an evaluation, under the 
supervision and with the participation of our 
management, including our principal executive officer 
and principal financial officer, of the effectiveness of 
the design and operation of our disclosure controls 
and procedures (as defined in Rules 13a-15(e) and 
15d-15(e) under the Securities Exchange Act of 1934, 
as amended), as of December 31, 2017. Based upon 
that evaluation, our principal executive officer and 
principal financial officer concluded that, as of the end 
of the period covered by this report, our disclosure 
controls and procedures are effective in ensuring that 
(a) the information required to be disclosed by us in 
the reports that we file or submit under the Securities 
Exchange Act is recorded, processed, summarized 
and reported within the time periods specified in the 
SEC’s rules and forms and (b) such information is 
accumulated and communicated to our management, 
including our principal executive officer and principal 
financial officer, as appropriate to allow timely 
decisions regarding required disclosure. In designing 
and evaluating our disclosure controls and 
procedures, our management recognized that any 
controls and procedures, no matter how well designed 
and operated, can provide only reasonable assurance 
of achieving the desired control objectives, and our 
management necessarily was required to apply its 
judgment in evaluating the cost-benefit relationship of 
possible controls and procedures.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control 
over financial reporting during the quarter ended 
December 31, 2017, that have materially affected, or 
are reasonably likely to materially affect, our internal 
control over financial reporting.
Management’s Annual Report on Internal Control 
over Financial Reporting
Our management is responsible for establishing 
and maintaining adequate internal control over our 
financial reporting. Internal control over financial 
reporting is defined in Rules 13a-15(f) and 15d-15(f) 
under the Securities Exchange Act as a process 
designed by, or under the supervision of, a company’s 
principal executive and principal financial officers and 
effected by a company’s board of directors, 
management and other personnel to provide 
reasonable assurance regarding the reliability of 
financial reporting and the preparation of financial 
statements for external purposes in accordance with 
U.S. GAAP. Our internal control over financial reporting 
includes those policies and procedures that:
•  pertain to the maintenance of records that, in 
reasonable detail, accurately and fairly reflect 
our transactions and dispositions of our assets;
•  provide reasonable assurance that transactions 
are recorded as necessary to permit preparation 
of financial statements in accordance with 
U.S. GAAP, and that our receipts and 
expenditures are being made only in accordance 
with authorizations of our management and 
directors; and
•  provide reasonable assurance regarding 
prevention or timely detection of unauthorized 
acquisition, use or disposition of our assets that 
could have a material effect on our financial 
statements.
Because of its inherent limitations, internal 
control over financial reporting may not prevent or 
detect misstatements. Projections of any evaluation 
of effectiveness to future periods are subject to the 
risk that controls may become inadequate because of 
changes in conditions, or that the degree of 
compliance with the policies or procedures may 
deteriorate.
Our management assessed the effectiveness of 
our internal control over financial reporting as of 
December 31, 2017. In making this assessment, 
management used the criteria set forth by the 
Committee of Sponsoring Organizations of the 
Treadway Commission (COSO) in its 2013 Internal 
Control — Integrated Framework.
Based on our assessment, our management has 
concluded that, as of December 31, 2017, our 
internal control over financial reporting is effective 
based on those criteria.
The effectiveness of our internal control over 
financial reporting as of December 31, 2017, has 
been audited by PricewaterhouseCoopers LLP, an 
independent registered public accounting firm, as 
stated in their attestation report, which is included 
herein.
Item 9B.      Other Information
None.

---