United states securities and exchange commission

Table of Contents
39
•  the interests of our collaborators or third parties may not always be aligned with our interests, and such parties 
may not pursue regulatory approvals or market a product in the same manner or to the same extent that we 
would, which could adversely affect our revenues; 
•  third-party relationships and collaborations often require the parties to cooperate, and failure to do so 
effectively could adversely affect product sales, or the clinical development or regulatory approvals of products 
under joint control or could result in termination of the research, development or commercialization of product 
candidates or result in litigation or arbitration; and
•  any failure on the part of our collaborators or other third parties to comply with applicable laws and regulatory 
requirements in the marketing, sale and maintenance of the marketing authorization of our products or to fulfill 
any responsibilities our collaborators or other third parties may have to protect and enforce any intellectual 
property rights underlying our products could have an adverse effect on our revenues as well as involve us in 
possible legal proceedings.
Given these risks, there is considerable uncertainty regarding the success of our current and future 
collaborative efforts. If these efforts fail, our product development or commercialization of new products could be 
delayed or revenues from products could decline.
Our business may be adversely affected if we do not successfully execute our growth initiatives.
We anticipate growth through internal development projects, commercial initiatives and external opportunities, 
which may include the acquisition, partnering and in-licensing of products, technologies and companies or the entry 
into strategic alliances and collaborations. While we believe we have a number of promising programs in our pipeline, 
failure of internal development projects to advance or difficulties in executing on our commercial initiatives could 
impact our current and future growth, resulting in additional reliance on external development opportunities for 
growth. The availability of high quality, cost-effective development opportunities is limited and competitive, and we 
are not certain that we will be able to identify candidates that we and our shareholders consider suitable or 
complete transactions on terms that are acceptable to us and our shareholders. We may fail to complete 
transactions for other reasons, including if we are unable to obtain desired financing on favorable terms, if at all. 
Even if we are able to successfully identify and complete acquisitions and other strategic alliances and 
collaborations, we may face unanticipated costs or liabilities in connection with the transaction or we may not be 
able to integrate them or take full advantage of them or otherwise realize the benefits that we expect.
Supporting our growth initiatives and the further development of our existing products and potential new 
products in our pipeline will require significant capital expenditures and management resources, including 
investments in research and development, sales and marketing, manufacturing capabilities and other areas of our 
business. If we do not successfully execute our growth initiatives, then our business and financial results may be 
adversely affected and we may incur asset impairment or restructuring charges.
Management and key personnel changes may disrupt our operations, and we may have difficulty retaining key 
personnel or attracting and retaining qualified replacements on a timely basis for management and other key 
personnel who may leave the Company.
We have experienced changes in management and other key personnel in critical functions across our 
organization, including our chief executive officer and our chief financial officer. Changes in management and other 
key personnel have the potential to disrupt our business, and any such disruption could adversely affect our 
operations, programs, growth, financial condition and results of operations. Further, new members of management 
may have different perspectives on programs and opportunities for our business, which may cause us to focus on 
new business opportunities or reduce or change emphasis on our existing business programs.
Our success is dependent upon our ability to attract and retain qualified management and key personnel in a 
highly competitive environment. Qualified individuals are in high demand, and we may incur significant costs to 
attract them, particularly at the executive level. We may face difficulty in attracting and retaining key talent for a 
number of reasons, such as management changes, the underperformance or discontinuation of one or more late 
stage programs or recruitment by competitors. We cannot assure you that we will be able to hire or retain the 
personnel necessary for our operations or that the loss of any such personnel will not have a material impact on our 
financial condition and results of operations.

---

Table of Contents
40
We are pursuing opportunities to expand our manufacturing capacity for future clinical and commercial 
requirements for product candidates, which will result in the incurrence of significant investment with no assurance 
that such investment will be recouped.
While we believe we currently have sufficient large scale manufacturing capacity to meet our near-term 
manufacturing requirements, it is probable that we would need additional large scale manufacturing capacity to 
support future clinical and commercial manufacturing requirements for product candidates in our pipeline, if such 
candidates are successful and approved. We are building a large-scale biologics manufacturing facility in Solothurn, 
Switzerland. Due to the long lead times necessary for the expansion of manufacturing capacity, we expect to make 
significant investments to build or obtain third-party contract manufacturers with no assurance that such investment 
will be recouped. If we are unable to adequately and timely manufacture and supply our products and product 
candidates or if we do not fully utilize our manufacturing facilities, our business may be harmed.
If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could 
face increased costs, penalties and a loss of business.
Our activities, and the activities of our collaborators, distributors and other third-party providers, are subject to 
extensive government regulation and oversight both in the U.S. and in foreign jurisdictions. The FDA and comparable 
agencies in other jurisdictions directly regulate many of our most critical business activities, including the conduct of 
preclinical and clinical studies, product manufacturing, advertising and promotion, product distribution, adverse event 
reporting and product risk management. Our interactions in the U.S. or abroad with physicians and other health care 
providers that prescribe or purchase our products are also subject to government regulation designed to prevent 
fraud and abuse in the sale and use of the products and place significant restrictions on the marketing practices of 
health care companies. Health care companies such as ours are facing heightened scrutiny of their relationships 
with health care providers from anti-corruption enforcement officials. In addition, health care companies such as 
ours have been the target of lawsuits and investigations alleging violations of government regulation, including 
claims asserting submission of incorrect pricing information, impermissible off-label promotion of pharmaceutical 
products, payments intended to influence the referral of health care business, submission of false claims for 
government reimbursement, antitrust violations or violations related to environmental matters. There is also 
enhanced scrutiny of company-sponsored patient assistance programs, including insurance premium and co-pay 
assistance programs and donations to third party charities that provide such assistance. If we, or our vendors or 
donation recipients, are deemed to fail to comply with relevant laws, regulations or government guidance in the 
operation of these programs, we could be subject to significant fines or penalties. Risks relating to compliance with 
laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic 
areas with different patient populations, which may have different product distribution methods, marketing programs 
or patient assistance programs from those we currently utilize or support. 
Regulations governing the health care industry are subject to change, with possibly retroactive effect, including:
•  new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or judicial 
decisions, related to health care availability, pricing or marketing practices, compliance with wage and hour laws 
and other employment practices, method of delivery, payment for health care products and services, compliance 
with health information and data privacy and security laws and regulations, tracking and reporting payments and 
other transfers of value made to physicians and teaching hospitals, extensive anti-bribery and anti-corruption 
prohibitions, product serialization and labeling requirements and used product take-back requirements; 
•  changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new 
products and result in lost market opportunity; 
•  the hiring freeze implemented by the federal government in 2017, including at the FDA, could impact the review 
and potential approval of new products, which may adversely affect our business and financial condition;
•  requirements that provide for increased transparency of clinical trial results and quality data, such as the EMA’s 
clinical transparency policy, which could impact our ability to protect trade secrets and competitively-sensitive 
information contained in approval applications or could be misinterpreted leading to reputational damage, 
misperception or legal action which could harm our business; and
•  changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, 
restrictions on product distribution or use, or other measures after the introduction of our products to market, 
which could increase our costs of doing business, adversely affect the future permitted uses of approved 
products or otherwise adversely affect the market for our products.

---