In May 2017, Brazilian authorities seized records and data from our Sao Paulo, Brazil offices as part of an investigation being conducted into our Brazilian operations. Any determination that our operations or activities are not, or were not, in compliance with existing U.S. or foreign laws or regulations, could result in the imposition of a broad range of civil and criminal sanctions against us and certain of our directors, officers and/or employees, including injunctive relief, disgorgement, substantial fines or penalties, imprisonment, and other legal or equitable sanctions, including exclusion from Medicare, Medicaid, and other governmental healthcare programs. Any determination that our operations or activities are not or were not in compliance with existing laws or regulations could result in the imposition of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief, and/or other sanctions against us, and remediation of any such findings could have an adverse effect on our business operations. The U.S. FDA approved a new formulation of our long-acting C5 complement inhibitor for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated TMA. Alexion is cooperating with these investigations. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the FCPA in various countries. Additionally, remediation of any such findings resulting from these and any future investigations could have an adverse effect on our business operations, and we could experience interruptions of business, harm to our reputation, debarment from government contracts, loss of supplier, vendor or other third-party relationships, and necessary licenses and permits could be terminated. In accordance with generally accepted accounting principles, if the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, we accrue a liability for the estimated loss. See Note 18, “Commitments and Contingencies” to the footnotes to the consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information on our material legal proceedings. Any future litigation or investigation may also likely be expensive and time consuming. From a financial standpoint, Alexion is doing very well. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. Data Provided by Refinitiv. On a quarterly basis, we review the status of each significant matter and assess its potential financial exposure. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the FCPA in various countries. Ludwig Norbert Michel Hantson (born August 1962) is a Belgium businessman, the CEO of Alexion Pharmaceuticals since March 2017. Uncover why Alexion Pharmaceuticals,Inc. In addition, any remedial actions that have been or will be taken with the intent to address the matters that were the subject of these or other governmental investigations may not prevent future investigations and potential liability as a result of such further investigations. Copy link. In addition, in October 2015, we received a request from the DOJ for the voluntary production of documents and other information pertaining to our compliance with the FCPA. Alexion is committed to strengthening its compliance program and is currently implementing a comprehensive company-wide transformation plan that is designed to enhance and remediate its business processes, structures, controls, training, talent and systems across Alexion’s global operations. We are cooperating with the open investigations. Alexion is cooperating with these investigations. Management. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare and devastating diseases through the discovery, development and commercialization of life-changing medicines. In addition, in October 2015, we received a request from the DOJ for the voluntary production of documents and other information pertaining to Alexion’s compliance with FCPA. Search alexion pharmaceuticals jobs. February 6, 2019 Form 10-K Alexion is cooperating with the SEC’s investigation, which is in its early stages. • customs and tax officials in foreign jurisdictions may disagree with the value we set when we or others import our products (including products that are donated for charitable purposes) and we may be required to pay additional duties or fines and such amounts may be substantial; Minimum 15 minutes delayed. The off-label promotion of medicinal products is prohibited in the EU and in other territories. Alexion Pharmaceuticals delivered a significant beat to revenue and earnings per share (EPS) expectations, with sales hitting US$1.6b, some 11% … We are cooperating with these investigations. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. There can be no assurance that any current or future discussions with the SEC or DOJ to resolve these matters will be successful or that any potential settlement terms or amount will be agreed to or finalized. In addition, in October 2015, Alexion received a request from the DOJ for the voluntary production of documents and other information pertaining to Alexion’s compliance with the FCPA. Any determination that our operations or activities are not, or were not, in compliance with existing U.S. or foreign laws or regulations, could result in the imposition of a broad range of civil and criminal sanctions against us and certain of our directors, officers and/or employees, including injunctive relief, disgorgement, substantial fines or penalties, imprisonment, and other legal or equitable sanctions, including exclusion from Medicare, Medicaid, and other governmental healthcare programs. In February 2016, the company held the dedication ceremony for its new headquarters in New Haven, Connecticut, not far from the company… Get the inside scoop on jobs, salaries, top office locations, and CEO insights. Find out what works well at Alexion Pharmaceuticals,Inc. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the FCPA in various countries. 1 Historically, two thirds of patients with the most common mutation required kidney dialysis, had permanent kidney damage, or died within the first year after diagnosis, despite supportive care. The investigations have focused on operations in various countries, including Brazil, Colombia, Japan, Russia and Turkey, and Alexion’s compliance with the FCPA and other applicable laws. We understand that the U.S. Attorney’s Office is coordinating its inquiry with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the FCPA in various countries. Get hired! At this time, we are unable to predict the duration, scope or outcome of these investigations. NEW HAVEN, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) today announced key additions to its executive leadership team effective June 5, 2017. April 25, 2019 Form 10-Q Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow as a consequence. Cooperating with and responding to requests for information in connection with these ongoing investigations, as well as responding to any future U.S. or foreign governmental investigation or whistleblower lawsuit, could result in substantial expenses, and could divert management’s attention from other business concerns and could have a material adverse effect on our business and financial condition and growth prospects. The SEC also seeks information related to Alexion’s recalls of specific lots of Soliris and related securities disclosures. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the Securities and Exchange Commission (SEC) requesting information related to our grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in various countries. If we were to engage in settlement discussions with respect to any current or future investigation or litigation (and we may accrue amounts due to the nature of such discussions), but the matter is not settled, the ultimate resolution may result in monetary or other penalties materially stricter or greater than the terms or amounts that we proposed in discussions (or the amount that we accrued for such matter during negotiations). April 27, 2017 Form 10-Q October 23, 2019 Form 10-Q April 26, 2018 Form 10-Q • unexpected changes in tariffs, trade barriers and regulatory requirements; June 13, 2018 Form 8-K It employs around 2,400 people worldwide. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the U.S. Foreign Corrupt Practices Act (FCPA) in various countries. Subscribe to FCPA Tracker today for an unparalleled view of self-disclosed and open FCPA-related investigations. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the Securities and Exchange Commission (SEC) requesting information related to our grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in various countries. Alexion is committed to compliance with applicable laws and regulations and strives to operate at the highest ethical standards in all of its markets. At this time, Alexion is unable to predict the duration, scope or outcome of these investigations. Fourth-quarter revenues came in at $1.4 billion, which is a 23% increase from Q4 2018. Like (0) See More. In May 2017, Brazilian authorities seized records and data from our Sao Paulo, Brazil offices as part of an investigation being conducted into Alexion’s Brazilian operations. Compare pay for popular roles and read about the team’s work-life balance. Recent years have seen a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more frequent and aggressive investigations and enforcement proceedings by both the DOJ and the SEC, increased enforcement activity by non-U.S. regulators, and increases in criminal and civil proceedings brought against companies and individuals. Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow as a consequence. The investigations have focused on operations in various countries, including Brazil, Colombia, Japan, Russia and Turkey, and Alexion’s compliance with the FCPA and other applicable laws. The SEC and DOJ also seek information related to Alexion’s recalls of specific lots of Soliris and related securities disclosures. from the people who know best. For example, in May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the FCPA in various countries. • difficulties or inability to obtain financing in markets; We are cooperating with the open investigations. In addition, in October 2015, we received a request from the U.S. Department of Justice (DOJ) for the voluntary production of documents and other information pertaining to Alexion’s compliance with FCPA. Additionally, remediation of any such findings could have an adverse effect on our business operations, and we could experience interruptions of business, harm to our reputation, debarment from government contracts, loss of supplier, vendor or other third-party relationships, and necessary licenses and permits could be terminated. While Alexion's year-over-year quarterly revenue growth of 20.1% doesn't come close to Vertex's, in the long run it's easy to envision how Alexion's revenue … Any determination that our operations or activities are not in compliance with existing laws or regulations, by the SEC or DOJ in the above referenced matter for example, could result in the imposition of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief, exclusion from the federal healthcare programs, healthcare debarment, product recalls, reputational damage and modifications of our business practices and/or other sanctions against us, and remediation of any such findings could have an adverse effect on our business operations. Jun 22, 2020 at 11:00 AM PDT 2020 Bank of America Virtual Napa Biotech Conference. In addition, in October 2015, we received a request from the Department of Justice (DOJ) for the voluntary production of documents and other information pertaining to Alexion’s compliance with FCPA. Ludwig N. Hantson-Wikipedia. For information concerning the risks associated with the investigation, see our Risk Factor – “If we fail to comply with laws or regulations, we may be subject to investigations and civil or criminal penalties and our business could be adversely affected.” Increasing regulatory scrutiny of the promotional activities of pharmaceutical companies also has been observed in a number of EU Member States. In addition, in October 2015, Alexion received a request from the U.S. Department of Justice for the voluntary production of documents and other information pertaining to Alexion’s compliance with the FCPA. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the SEC requesting information related to our grant-making activities and compliance with the FCPA in various countries. Because of uncertainties related to claims, proceedings and litigation, accruals are based on our best estimates based on information available at the time of the assessment. In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the U.S. Securities and Exchange Commission (SEC) requesting information related to our grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in various countries. In May 2017, Brazilian authorities seized records and data from our Sao Paulo, Brazil offices as part of an investigation being conducted into our Brazilian operations. In addition, in October 2015, we received a request from the Department of Justice (DOJ) for the voluntary production of documents and other information pertaining to Alexion’s compliance with FCPA. All Rights Reserved. Alexion is a global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. In addition, in October 2015, we received a request from the DOJ for the voluntary production of documents and other information pertaining to Alexion’s compliance with FCPA. See Note 11 “ Commitments and Contingencies ” to the footnotes to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for information on our material legal proceedings. FCPA Tracker Copyright © 2017-2021 Recathlon LLC. Bribery Act and other anti-corruption laws and regulations that generally prohibit companies and their intermediaries from making improper payments to government officials and/or other persons for the purpose of obtaining or retaining business and we operate in countries that are recognized as having a greater potential for governmental and commercial corruption. A costly license, or inability to obtain a necessary license, could have a material adverse effect on our financial results. Alexion is cooperating with these investigations. In addition, in October 2015, we received a request from the DOJ for the voluntary production of documents and other information pertaining to Alexion’s compliance with FCPA. • costs and difficulties in managing and monitoring international operations; and Alexion is committed to strengthening its compliance program and is currently enhancing and continuing to implement a comprehensive company-wide transformation plan that is designed to enhance our business processes, structures, controls, training, talent and systems across Alexion’s global operations. If we were to engage in settlement discussions with respect to any current or future investigation or litigation (and we may accrue amounts due to the nature of such discussions), but the matter is not settled, the ultimate resolution may result in monetary or other penalties materially stricter or greater than the terms or amounts that we proposed in discussions (or the amount that we accrued for such matter during negotiations). At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier’s check to purchase new equipment. Any determination that our operations or activities are not in compliance with existing laws or regulations, by the SEC or DOJ in the above referenced matter for example, could result in the imposition of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief, exclusion from the federal healthcare programs, healthcare debarment, product recalls, reputational damage and modifications of our business practices and/or other sanctions against us, and remediation of any such findings could have an adverse effect on our business operations. Nice building, not the friendliest group. Alexion is cooperating with these investigations. See Note 11, Commitments and Contingencies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information on this matter. Alexion Pharmaceuticals, Inc. provides this data for informational and research purposes only. Although we can impose contractual restrictions on what they are authorized to do on our behalf, we will exercise only limited control over the actions of these third parties but may still face the same liabilities for their actions. Any determination that our operations or activities are not in compliance with the existing laws or regulations could result in the imposition of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief, and/or other sanctions against us, and remediation of any such findings could have an adverse effect on our business operations. While we have, and continue to, take steps that are intended to enhance our compliance and training programs, we cannot assure that our compliance program, policies and procedures will always protect us from acts committed by employees or third-parties acting on our behalf. Any attempts to resolve some or all of these matters may not be successful. Alexion is cooperating with these investigations. Costs associated with our involvement in legal proceedings are expensed as incurred. Report. Any attempts to resolve some or all of these matters may not be successful. In October 2018, the MHLW conducted an inspection of our Japanese operations and in March 2019, the MHLW indicated that its investigation is complete. Recent years have seen a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more frequent and aggressive investigations and enforcement proceedings by both the DOJ and the SEC, increased enforcement activity by non-U.S. regulators, and increases in criminal and civil proceedings brought against companies and individuals. Despite growing its EBITDA per share by nearly 100% since 2018, the … Revenue can be defined as the amount of money a company receives from its customers in exchange for the sales of goods or services. We are currently involved in various claims, disputes, lawsuits, investigations, administrative proceedings and legal proceedings. Listen to Webcast. Neither Alexion nor any of its data or content providers shall be liable for any errors or delays in the content, or for any actions taken in reliance thereon. At this time, we are unable to predict the duration, scope or outcome of the open investigations. New Haven, Connecticut 06510, Date of Original Disclosure: Alexion is collaborating with Zealand Pharma A/S to discover and develop novel peptide … Alexion does not contact candidates via instant messaging or chat tools. Our business and operations may be materially adversely affected by government investigations. While it is possible that a loss related to these matters may be incurred, given the ongoing nature of these investigations, management cannot reasonably estimate the potential magnitude of any such loss or range of loss, or the cost of the ongoing investigation. In addition, in October 2015, Alexion received a request from the DOJ for the voluntary production of documents and other information pertaining to Alexion’s compliance with the FCPA, and in December 2016, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts requesting documents relating generally to our support of 501(c)(3) organizations that provide financial assistance to Medicare patients, Alexion’s provision of free drug to Medicare patients and Alexion’s related compliance policies and training materials.