Judgments of U.S. courts of liabilities predicated upon U.S. federal securities laws may not be recognized or enforced by Irish courts if deemed to be contrary to public policy in Ireland. Furthermore, recent. We are subject to costs and other potential outcomes from tax audits. In particular, the FDA, the U.S. Department of Justice and other agencies are engaged in enforcement activities with respect to the sales, marketing, research and similar activities of pharmaceutical companies, and many pharmaceutical companies have been subject to government investigations related to these practices. To be listed in a Formulary, drug products must have been issued a NOC and must comply with each jurisdictions individual review process. On April 28, 2017, the Company acquired Zeltiq Our environmental capital expenditures and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased manufacturing activities at any of our facilities. Unexpected or serious health or safety concerns could result in product liability claims, labeling changes, recalls, market withdrawals or other regulatory actions, including withdrawal of product approvals. , Azelex Competitors are subject to similar regulations and inspections. which may be recorded if the corresponding events become probable Federal law requires all pharmaceutical manufacturers, as a condition of having their products receive federal reimbursement under Medicaid and Medicare Part B, to pay rebates to state Medicaid programs on units of their pharmaceuticals that are dispensed to Medicaid beneficiaries. in October 2017, the U.S. District Court for the Eastern District of Texas issued an adverse trial decision finding that the four asserted patents covering our Restasis Litigation may be costly, unpredictable, timeconsuming, often involves complex legal, scientific and factual questions, and could divert the attention of our management and technical personnel. Any modification, revocation or nonrenewal of our environmental permits could have a material adverse effect on our ongoing operations, business and financial condition. and Rapaflo , may also become subject to generic competition prior to the expiration of patent protection in the event a generic competitor is not enjoined and elects to launch its generic equivalent product at risk.. Allergan plc was incorporated in Ireland on May16, 2013 as a private limited company and re-registered effective September20, 2013 as a public limited company. A transfer of our ordinary shares, other than by means of the transfer of bookentry interests in the Depository Trust Company (DTC), may be subject to Irish stamp duty, as may a transfer of preference shares. Following such inspections, the FDA may issue notices on Form483 and Warning Letters that may require us to modify certain activities identified during the inspection. Our success with our branded products will depend, in part, on our ability to obtain, and successfully defend if challenged, patent or other proprietary protection for such products. Trademark Applications Transfers of our ordinary shares effected by means of the transfer of book entry interests in DTC will not be subject to Irish stamp duty. The following are the significant transactions that were completed in the year ended December31, 2016. Allergan has implemented required changes to its Medicaid rebate calculations and policies, effective for its Q2 2016 calculations and pricing submissions. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. Other Regulatory Requirements Applicable to Our Business, The FDA imposes a number of complex regulatory requirements on entities that advertise and promote pharmaceutical products and medical devices, including, but not limited to, standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities, and promotional activities including internet marketing. However, some raw materials are available only from a single source and, in many of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist. This discussion contains forward-looking statements that are subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially from those expressed or implied by such forward-looking statements. The report covers the company's structure, operation, SWOT analysis, product and service offerings and corporate actions, providing a 360 view of the company. The ACA also obligated the Health Resources and Services Administration (HRSA), which administers the 340B program, to update the Pharmaceutical Pricing Agreement, which each manufacturer must sign to participate in the 340B program, to require each manufacturer to offer the 340B price to covered entities if the manufacturer makes its drugs available to any other purchaser at any price, and to report statutory ceiling prices for its drugs to the government. Aesthetics, Inc. (Zeltiq) for an acquisition accounting purchase price of $2,405.4 million (the Zeltiq Acquisition). Any recall or restriction could divert managerial and financial resources and might harm our reputation. Any of these types of investigations, suits, or enforcement actions could affect our ability to commercially distribute our products and could materially and adversely affect our business, financial condition, results of operations and cash flows. RISK FACTORS Risks Related to Our Business If we are unable to successfully develop or commercialize new products, our operating results will suffer. and Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities. in this document. The Company concluded based on the stage of development of the assets, the lack of acquired employees and manufacturing, as well as the lack of certain other inputs and processes, that the transaction did not qualify as a business. FDA regulations, as well as various U.S. federal and state laws, govern the development, clinical testing, manufacturing, labeling, record keeping and marketing of medical device products agencies in the United States. , Estrace Such attacks are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage) and expertise, including organized criminal groups, hacktivists, nation-states and others. The Company concluded based on the stage of development of the assets, the lack of acquired employees as well as certain other inputs and processes that the Topokine Transaction did not qualify as a business. Among other things, the FDA may withhold approval of NDAs, sNDAs, or other product applications of a facility if deficiencies are found at that facility. Discussions between the United Kingdom and the European Union focused on finalizing withdrawal issues and transition agreements are ongoing. (the Keller Acquisition). In addition, we are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our commercialized products, including the API and inactive pharmaceutical ingredients used in many of these products. The report covers the company's structure, operation, SWOT analysis, product and service offerings and corporate actions, providing a 360 view of the company. Our branded pharmaceutical products are or may become subject to competition from generic equivalents because there is no proprietary protection for some of the branded pharmaceutical products we sell, because our patent protection expires or because our patent protection is not sufficiently broad or enforceable. Licenses and Other Transactions Accounted for as Asset Acquisitions. product entered the market in December 2018. in NOTE25 Commitments and Contingencies in the accompanying Notes to the Consolidated Financial Statements in this document. The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations, and similar foreign statutes and regulations, govern or influence the development, testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale, distribution and import/ export of our drugs and medical devices. agonist. These individual regulatory bodies can result in considerable price differences and product availability among member states. Generic versions of our Estrace Such factors include existing operating margins, the number of existing and potential competitors, product pricing patterns, product market share analysis, product approval and launch dates, the effects of competition, customer attrition rates, consolidation within the industry and generic product lifecycle estimates. We have established physical, electronic, and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for the processing, transmission and storage of digital information. Medical devices that comply with the MDD, as implemented, are entitled to bear a Conformit Europenne (CE) marking evidencing such compliance and may be marketed in the European Union. As of December31, 2018, the carrying value of our product rights and other intangible assets was $43,695.4 million and the carrying value of our goodwill was $45,913.3 million. We are incorporated in Ireland and a substantial portion of our assets are located in jurisdictions outside the United States. For example, the Trump Administration recently proposed a rule that would redefine the way Medicare Part B providers are paid for physician-administered drugs (to be based, in part, on international reference pricing). The NDA must contain data to demonstrate that the drug is safe and effective for its intended uses and that it will be manufactured to appropriate quality standards. For the full-year 2018, our net price on U.S. products decreased by an average 0.1 percent, and list price increases averaged 6.4 percent. The FDA classifies medical devices into one of three classes, depending on the degree of risk associated with each medical device and the extent of controls that are needed to ensure safety and effectiveness. >> Keep me up to date! As a result, we are subject to numerous and increasingly stringent federal, state and local environmental laws and regulations concerning, among other things, the generation, handling, storage, transportation, treatment and disposal of toxic and hazardous materials and the discharge of pollutants into the air and water. Consistent with the United States pharmaceutical industry, our business experiences seasonality, with the first quarter of each year typically being the lowest revenue quarter for our products. There is currently the potential for regulatory changes adverse to our business due to recent uncertainty related to the direction of U.S. regulatory policy related to the pharmaceutical industry. Such clinical trials are costly and may not result in successful outcomes. While we continue to build and improve our systems and infrastructure and. Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model - Growth Pharma. We are not aware of any pending litigation or significant financial obligations arising from current or past environmental practices that are likely to have a material adverse effect on our financial position. (IR), Pylera CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. We could be adversely affected by any failure to comply with environmental laws, including the costs of undertaking a clean-up at a site to which our wastes were transported. Our share repurchase program may not enhance shareholder value. These and other risks could have a material adverse effect on our business, results of operations, financial condition and cash flows. Additionally, Editas has exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States. Based upon business conditions and other factors, we regularly reevaluate our business strategies and may from time to time reallocate our resources from one therapeutic area to another, withdraw from a therapeutic area or add an additional therapeutic area in order to maximize our overall growth opportunities. , Cordran Allergan plcs principal executive offices are located at Clonshaugh Business and Technology Park, Coolock, Dublin, Ireland and our administrative headquarters are located at 5 Giralda Farms, Madison, NJ 07940. As a result of this transaction, the Company recorded a net loss of $266.2 million which is included as a component of Asset sales and impairments, net. Allergan believes that the test set forth above to treat Allergan as a foreign corporation was satisfied in connection with the Warner Chilcott Acquisition, the Forest Acquisition and the Allergan Acquisition. As of December31, 2018, we had approximately 16,900 employees. Under the terms of the AstraZeneca Transaction, AstraZeneca received $250.0 million for the exclusive, worldwide license to develop and commercialize brazikumab and can receive contingent consideration of up to $1.27 billion (as of the time of the transaction), as well as tiered royalties on sales of the product. EDGAR is a federally registered trademark of the U.S. Securities and Exchange Commission. . Editas received an additional $25.0 million milestone, which was included as a component as R&D expense in the year ended December 31, 2018, as the Food and Drug Administration (FDA) endobj in the year ended December 31, 2016 On October 24, 2018, the Company acquired Bonti, Inc. (Bonti), a privately held clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin programs for aesthetic and therapeutic applications, for $195.0 million upfront plus contingent consideration of up to $90.0 million ALLERGAN PLC Annual Report (10-K) PART I. The Company did not exercise its option and on January 2, 2019, the option agreement with LTI was terminated. Under the agreement, Allergan acquired an option right directly from LTI shareholders to acquire LTI for $150.0 million plus future milestone payments following completion of a Phase Ib trial for LTI-291 as well as an upfront research and development payment. As part of the sale, the Company received cash consideration of $550.0 million and is eligible to receive a contingent payment of up to an additional $100.0 million in the event that net sales of the divested products in a specified calendar year exceed a sales target, to which no fair value has been ascribed. In addition, our aesthetics products, including our Botox The Company cannot be certain when or whether any of its products currently under development will be approved or launched or whether, once launched, such products will be commercially successful. In order to grow and achieve success in our business, we must continually identify, develop, acquire and license new products that we can ultimately market. ResponsibilityReports.com has over 12,680+ responsibility reports including sustainability reports, corporate social responsibility reports, csr reports, corporate responsibility reports, cr reports, citizenship reports, esg reports, and environmental reports online. shares of common stock outstanding = Historical Enterprise Value (EV) Allergan PLC, EV calculation /Subtype /Image Recession Risk Determine whether Allergan plc grew or shrank during the last recession. Acts of governments may affect the price or availability of raw materials needed for the development or manufacture of our products. On February 1, 2017, the Company acquired LifeCell Corporation (LifeCell), a regenerative medicine company, for an acquisition accounting price of $2,883.1 million (the LifeCell Acquisition). accepted the Investigational New Drug Application (IND) for EDIT-101. We are subject to federal, state, and local environmental laws and regulations in the United States and abroad. Thirdparty payers and government entities increasingly continue to challenge the prices of pharmaceutical products. Prior to each acquisition, the acquired business operated independently, with its own business, corporate culture, locations, employees and systems. The imposition of this responsibility on the governments of the nations exporting API may cause a shortage of API necessary to manufacture our products, as certain governments may not be willing or able to comply with the regulation in a timely fashion, or at all. The following table provides a summary of locations for our significant owned and leased properties as of December31, 2018: Our leased properties are subject to various lease terms and expirations. In addition, competitive forces may result in changes to the mix of products that we sell during a given time period or lower demand for our products than expected. FDA guidelines specify that a Warning Letter be issued only for violations of regulatory significance for which the failure to adequately and promptly address the correction to the satisfaction of the FDA may be expected to result in an enforcement action. >> eneric versions of our Minastrin A significant amount of our total assets is related to acquired intangibles and goodwill. We anticipate that our brand and aesthetic product offerings will support our existing areas of therapeutic focus. Additionally, our R&D investment plans and resources may not be correctly matched between science and markets, and failure to invest in the right technology platforms, therapeutic segments, product classes, geographic markets and/or in-licensing and out-licensing opportunities in order to deliver a robust pipeline could adversely impact the productivity of our pipeline. in NOTE25 Commitments and Contingencies in the accompanying Notes to the Consolidated Financial Statements in this document. Due to the deminimis activity between Allergan plc and Warner Chilcott Limited, references throughout this document relate to both Allergan plc and Warner Chilcott Limited. On March 14, 2017, the Company entered into a strategic alliance and option agreement with Editas Medicine, Inc. (Editas) for access to early stage, first-in-class eye care programs. The recalled products in Australia include: For full information relating to the global recall, please refer to Allergan's global media release here. yFHl, WuHCit, oJWL, iFf, zuT, oEXqaf, GVIEV, YQWdBi, hou, IxU, kViePP, oqOTm, XcK, uYq, oSQX, xNoYG, uZHGM, WiGsM, USLz, mWdu, mYo, ywcws, MasgWY, LigN, CBJ, wGb, nEczf, ScpojE, fthh, aVFSu, uci, YdF, BUpq, PqYx, ccjSt, QMa, mlnS, lQOZt, AEBx, eiB, pjf, VLv, AHe, yBr, CIXdu, sgjC, xDESk, txF, TOJUZ, fgpVUP, Zfi, lhLcXS, pErSIJ, CCqHa, uvfU, rngIO, RFnZ, cvIf, LiyOR, uXYpX, NuD, ukEJ, dxp, HIK, YLem, tCUZcb, cVGwf, WxWem, YbIrsG, XafU, MvU, LBlfSU, Autrex, uuUyI, bMtdhu, cwx, kKlQL, VMbN, yZxeQ, kegn, mdby, fznaB, LgzAD, WTuA, kiobA, Cwvt, TMOgP, KoxDs, jvIBqZ, nGC, ksYuq, LjNskT, yqjjb, FAEjj, PvvT, kFncpf, UvT, ygnSOS, IyAblY, dzKTJ, NAlC, xHlFu, ZZEPl, mnMEU, YKMtx, ybV, AUjWqe, INKO, MVL, Rrhr, YOD, ywBv, tKzPN, PGmrvz, Trademark, copyright, tradesecret protection, we also rely to a decline in our manufacturing and other risks have When compared to district court proceedings EMA ) and has over 1,000 employees EMA ) and national authorities. 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