The Commission asserted jurisdiction to review the acquisition under Article 22 of the EU Merger Regulation on April 19, 2021, seven months after the deal was announced. On 23 September 2023, Illumina appealed the EU General Court's judgment before the. In a landmark decision, the European Commission (Commission) has prohibited Illumina's $7.1 billion completed acquisition of GRAIL, following an Article 22 EU Merger Regulation (EUMR) referral. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, such as statements about the effects of the consummation of the transaction and the anticipated benefits thereof. The Illumina-Grail kibosh is just the 10th deal the bloc has rejected . In a landmark decision announced on September 6, 2022 ("Decision"), the European Commission ("EC") prohibited the acquisition by Illumina, a U.S. company specialising in genomic sequencing, of GRAIL, a U.S.-based start-up developing early cancer-detection tests ("Transaction"). Products, DRAGEN v4.0 release enables machine learning by default, providing increased accuracy out of the box, Fast, high-quality, sample-to-data services such as RNA and whole-genome sequencing, Whole-exome sequencing kit with library prep, hybridization reagents, exome probe panel, size selection beads, and indexes, See what is possible through the latest advances in high-throughput sequencing technology, View the unveiling of our newest technologies and products on-demand, recorded live at the Illumina Genomics Forum, Get instructions for using Illumina DRAGEN Bio-IT Platform v4.0, A campus lab sequences dust from vacuum bags to understand the variants and viral load of SARS-CoV-2 and other viruses, Mapping genetic diversity to identify where confiscated gorillas come from and boost survival rates, Explore the advantages of NGS for analysis of gene expression, gene regulation, and methylation, The NovaSeq 6000Dx is our first IVD-compliant high-throughput sequencing instrument for the clinical lab. Software Suite, BaseSpace Illumina has already announced that it will appeal the Decision to the General Court, following its appeal to the Court of Justice of the General Courts July 2022 judgment finding the EC had jurisdiction under Article 22 EUMR. Retailer Reg: 2019--2018 | The acquisition will allow Illumina to bring GRAILs lifesaving testing to more patients, more quickly and at a lower cost.. Tax Reg: 105-87-87282 | SAN DIEGO, Sept. 6, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ:ILMN), today received a decision from the European Commission prohibiting the company's acquisition of GRAIL. The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL. Dr. Karen Birmingham Apps, DRAGEN Illumina is the only provider of DNA sequencing that . On Aug. 18, Illumina announced it had completed the $8 billion purchase of Grail, despite regulatory action in the US and Europe, but intends to hold the companies separate until those proceedings are resolved, one way or the other. Sep 6, 2022 08:03AM EDT (RTTNews) - Illumina Inc. (ILMN) said Tuesday that it intends to appeal the European Commission's decision that prohibited the company's proposed $7.1 billion. Greenwood Genetic Center: Answering the Unanswered, Rarebase Is on the Hunt for Therapeutic Opportunities, Empowering the Disability Community at Illumina, BaseSpace [1] In addition, Galleri can identify the tissue in which a cancer has developed. Important risk factors that may cause such a difference include, but are not limited to: (i) the terms and conditions of any required divestiture of GRAIL, and the timing of and the risks, costs and business disruptions (including the diversion of management's attention) associated with any such divestiture, the announcement, pendency or implementation thereof or any associated legal or regulatory proceedings or obligations, and other uncertainties related to Illumina's compliance (or ability to comply) with a divestment order, which may adversely affect Illumina and its business, including current plans and operations; (ii) the possibility of other adverse consequences to, among other things, Illumina's reputation, its relationships with governmental or regulatory authorities or its ability to successfully complete future acquisitions and/or divestitures as a result of the acquisition, the prohibition decision or a divestment order; (iii) the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, dis-synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of Illumina's business following or in connection with any divestiture of GRAIL; (iv) potential adverse reactions or changes to business relationships or our ability to attract and retain employees resulting from the announcement, pendency or implementation of the prohibition decision and/or legal, regulatory and other proceedings related thereto; (v) any negative effects of the announcement, pendency or implementation of the prohibition decision or a divestment order and/or of any divestiture of GRAIL on the market price of Illumina's common stock and on Illumina's operating results; (vi) risks associated with third-party contracts or other agreements containing provisions that might be implicated by any divestiture of GRAIL, including Illumina's obligations with respect to certain GRAIL contingent value rights and the risk that Illumina will be unable to fully discharge such obligations in connection with a divestiture of GRAIL; (vii) the risk that Illumina will be unable to recover the costs and/or realize the economic benefits associated with its efforts to develop and commercialize GRAIL's products, including Galleri, the cancer screening test developed by GRAIL; (viii) the risk that Illumina's appeals of the prohibition decision or a divestment order and the EU General Court's ruling on the European Commission's jurisdiction to review the Acquisition and impose any decisions with respect thereto are unsuccessful and of other negative outcomes of legal, regulatory and other proceedings related thereto; (ix) the risk of adverse effects resulting from additional potential litigation associated with the acquisition; (x) the other risks described in Illumina's most recent annual reports on Form 10-K and quarterly reports on Form 10-Q and (xi) management's response to any of the aforementioned factors. will appeal a fresh decision from the European Commission that prohibits the gene-sequencing company from acquiring biotechnology company Grail. Illumina filed a Form 8-K with the SEC on August 18, 2021 admitting that "As a result of Illumina's decision to proceed with the completion of the Acquisition during the pendency of the European Commission's review, the European Commission will likely seek to impose a fine on Illumina pursuant to Article 14(2)(b) of the EU Merger . Compliance with the order is monitored by an independent monitoring trustee. Both are U.S. biotechnology companies, with Illumina manufacturing systems for genetic analysis, while Grail develops cancer screening tests. Second, the Decision confirms the ECs increasing scrutiny of vertical mergers and its skepticism of non-divestiture-like remedies. For the need of its activity, the latter needs genomic sequences to develop its tests. On 13 July 2022, the EU's General Court rejected a request to annul the European Commission's (the "Commission") decision to review the $7.1 billion acquisition of biotech company GRAIL by Illumina. This case involved many "firsts": It is the first time that the EC prohibited the acquisition of a U.S. startup with no revenues in the European Union; it is the first time . On the substance of the case, Illumina challenged the Commission's Decisions on three points, essentially alleging: 1) a lack of competence on the part of the Commission, 2) that the referral request of France was late and 3) that the Decisions violated the principle of protection of legitimate expectations. Bio-IT Platform, TruSight This whole thing becomes a moot point if the FTC decides to disband the Illumina-GRAIL merger. Illumina notified the Transaction to the EC in June 2021 and closed the Transaction in August 2021 before the EC had completed its investigation. Vice-President Margrethe Vestager, in charge of competition policy, commented that she intended to suggest a separate decision ordering Illumina and GRAIL to dissolve the transaction and restore GRAIL's independence. EU institutions; European Union; About the Commission's new web presence; Language policy; Second, the EC found that Illumina would have an incentive to foreclose GRAILs putative rivals in light of the lucrative and expanding early cancer detection market, expected to be worth 40 billion per annum globally by 2035. In addition, to prepare for the anticipated divestment order from the European Commission in the coming months, the company will begin reviewing strategic alternatives for GRAIL in the event the divestiture is not stayed pending Illumina's appeal. The Commissions actions will stifle innovation, fail patients and increase healthcare costs by needlessly delaying this transaction. EC Press Release IP/22/343, Mergers: Commission prohibits proposed acquisition of Daewoo Shipbuilding & Marine Engineering by Hyundai Heavy Industries Holdings, January 13, 2022. [6] See Cleary Gottlieb Alert Memo, Illumina/Grail: General Court Upholds ECs Merger Referral Policy, Expanding EC Jurisdiction Over Non-reportable Transactions, July 18, 2022. September 20, 2022 Following a Phase II investigation, the European Commission (the " Commission ") on 6 September 2022 prohibited the acquisition of Grail by Illumina, on the basis that the merger would allegedly stifle innovation in the emerging market for early cancer detection tests based on sequencing technologies. The EC based its Decision on input foreclosure: that the Transaction would have enabled and incentivised Illumina to foreclose GRAILs putative rivals that depend on Illuminas NGS technology from accessing an essential input they would need to develop and market blood-based early cancer detection tests. Downstream, Illumina offered a comprehensive remedy package including a commitment to supply GRAILs rivals under standard conditions until 2033. This increased scrutiny includes placing greater emphasis on the impact of putative foreclosure on potential competition concerns. Illuminas principal business is next-generation sequencing (NGS) instruments and consumables. Last week the Chief Judge of the US Federal Trade Commission issued a decision supporting Illumina acquiring GRAIL.". [17] EC SPEECH/22/5371, Remarks by Executive Vice-President Vestager on the Commission decision to prohibit the acquisition of GRAIL by Illumina, September 6, 2022. [3] Illumina formed GRAIL but spun it off in 2016 and retained a 14.5% shareholding. "Illumina and Grail completed their merger while our investigation is still ongoing. The deal between Illumina and Grail would have stifled innovation and reduced choice in the emerging market for blood-based early cancer detection tests, the European Commission said in a news release Tuesday. This morning the European Commission (EC) moved to unwind and block Illumina's $7.1 billion acquisition of Grail. On September 6, 2022, almost two years after its announcement, the EC prohibited the Transaction. The merger of Illumina and GRAIL would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the life-saving early cancer detection Galleri test. On September 6, 2022, the European Commission (Commission) announced that it had prohibited the acquisition by Illumina Inc., a U.S company supplying sequencing- and array-based solutions for genetic and genomic analysis, of Grail LLC, another U.S. company that develops blood tests for the early detection of cancers, under the EU Merger Regulation (EUMR). For specific trademark information, see www.illumina.com/company/legal.html. & Pipeline Setup, Sequencing Data Highlights, press releases and speeches An official website of the European Union An official EU website . The company said the "merger of Illumina and GRAIL would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the life-saving early cancer detection . The European Commissions unprecedented and untimely decision to review this procompetitive acquisition without proper engagement with the parties leaves businesses uncertain as to how the EU Merger Regulation will be applied, said Charles Dadswell, Senior Vice President and General Counsel for Illumina. [15] Reuters, U.S. judge backs Illumina deal for Grail in blow to FTC, September 2, 2022. 23. The European Commission has prohibited Illumina Inc's (NASDAQ: ILMN) acquisition of GRAIL. ir@illumina.com, Media: The EC considered that GRAILs rivals, which require high-throughput NGS systems with a reliable support network and a solid track record, could only source NGS systems from Illumina in the short- to medium-term in a market that would be characterized by high barriers to entry and long and costly switching. Macfarlanes LLP. In this context, forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "see," "will," "would," "may," "target," similar expressions and variations or negatives of these words. "The European Commission has renewed and adjusted, under the EU Merger Regulation, the interim measures that ensure that Illumina and GRAIL remain separate following the Commission's. Informations sur votre appareil et sur votre connexion Internet, y compris votre adresseIP, Navigation et recherche lors de lutilisation des sites Web et applications Yahoo. SAN DIEGO, Sept. 6, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ:ILMN), today received a decision from the European Commission prohibiting the company's acquisition of GRAIL. Upstream, Illumina committed to license NGS patents to NGS suppliers, and to stop patent litigation in the US and Europe against its competitor BGI for three years. September 12, 2022. The French NCA referred the Transaction in March 2021, and was then joined by the NCAs of Belgium, Greece, Iceland, the Netherlands, and Norway. kbirmingham@illumina.com. [5] Commission Guidance on the application of the referral mechanism set out in Article 22 of the Merger Regulation to certain categories of cases, March 26, 2021. Among the important factors to which our business is subject that could cause actual results to differ materially from expectations or guidance contained in any forward-looking statements are: (i) changes in the rate of growth in the markets we serve; (ii) the volume, timing and mix of customer orders among our products and services; (iii) the outcome of the pending acquisition of GRAIL, Inc.; (iv) challenges inherent in developing, manufacturing, and launching new products and services; (v) our ability to obtain regulatory clearance for our products from government agencies, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL. Illumina innovative sequencing and array technologies are fueling groundbreaking advancements in life science research, translational and consumer genomics, and molecular diagnostics. Tax Reg: 105-87-87282 | Illumina is separately appealing a July 2022 decision by the General Court of the European Union regarding the European Commission's jurisdiction to challenge the GRAIL deal. (a) See the tables included in "Results of Operations - Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures. In a landmark decision announced on September 6, 2022 (Decision), the European Commission (EC) prohibited the acquisition by Illumina, a U.S. company specialising in genomic sequencing, of GRAIL, a U.S.-based start-up developing early cancer-detection tests (Transaction). As a reminder, pending the outcome of the European Commission's investigation into Illumina's acquisition of GRAIL, the commission has adopted an order requiring Illumina and GRAIL to be held and operated as distinct and separate entities for an interim period. SAN DIEGO, Sept. 6, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ:ILMN), today received a decision from the EuropeanCommission prohibiting the company's acquisition of GRAIL. Not for use in diagnostic procedures (except as specifically noted). In September 2020, Illumina announced its acquisition of Grail. The Federal Trade Commission SAN DIEGO--(BUSINESS WIRE)-- Galleri is unique as a multicancer early detection test suitable for general population screening. In September, the European Commission moved to block the deal, issuing a prohibition order. On September 6, the European Commission (EC) moved to unwind and block Illumina's $7.1 billion acquisition of Grail. [4] Illumina Press Release, Illumina to Acquire GRAIL to Launch New Era of Cancer Detection, September 21, 2020. Illumina officials noted that the firm is taking a $3.91 billion "goodwill impairment" related to Grail, which it acquired for approximately $8 billion just over a year ago. Illumina is appealing this as well as the regulator's jurisdiction to review the deal, and expects a . [1] EC Press Release IP/22/5364, Mergers: Commission prohibits acquisition of GRAIL by Illumina, September 6, 2022 (EC Press Release). Grail is a company specialized in cancer tests. On 6 September 2022, the European Commission (EC or the Commission) prohibited Illumina's acquisition of Grail, bringing to an end the administrative stage of a legal saga that has attracted interest beyond competition law specialists.The Commission's decision follows the recent ruling by an Administrative Law Judge rejecting the U.S. Federal Trade Commission (FTC)'s challenge to the . Illumina announced Tuesday it plans to appeal the European Commission's decision to prohibit the company's acquisition of cancer detection company GRAIL. The company is . In October 2021, the EC adopted hold-separate and interim measures. This copy is for your personal, non-commercial use only. Illumina does not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws. On 6 September 2022, the European Commission (the "Commission") prohibited the acquisition of Grail, a biotech start-up, by Illumina, a large US biotech company (together the "Parties"). Sequence Hub, BaseSpace The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL. Grail has no sales within the European Union (and in fact within any country outside of the U.S.) which resulted in the transaction falling below notification thresholds in the EUboth at . Illumina announced that it intends to appeal the decision. 91 (Illumina vs. EC). Continue reading To order presentation-ready copies for distribution to your colleagues, clients or customers visit http://www.djreprints.com. & Pipeline Setup, Sequencing Data View source version on businesswire.com: "Illumina can make GRAIL's life-saving multi-cancer early detection test more available, more affordable, and more accessible saving lives and lowering healthcare costs. Variant Interpreter, MyIllumina The company is reviewing the Commission's order and intends to appeal the decision. Not for import or sale to the Australian general public. [2] The EC has previously blocked transactions referred to it by Member States before the adoption of their respective merger control regimes: RTL/Veronica/Endemol, Case IV/M.553, Commission decision of September 20, 1995; Kesko/Tuko, Case IV/M.784, Commission decision of November 20, 1996; and Blokker/Toys R Us (II), Case IV/M.890, Commission decision of June 26, 1997. The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL. First, the Decision confirms the uncertainty created by the ECs March 2021 Guidance Paper in respect of transactions involving targets that have no activities or turnover in the EU. SAN DIEGO, Sept. 6, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN ), today received a decision from the European Commission prohibiting the company's acquisition of GRAIL. [16] FTC, Complaint Counsels Notice of Appeal, September 2, 2022. Yet, days later, the European Commission ruled against the merger, contravening the FTC's decision and jeopardizing this advancement of lifesaving cancer-detection technology. 15 See Case T-227/21, Illumina vs. European Commission (13 July 2022) at para. In Illumina v Commission, the General Court has confirmed the authority of the European Commission (EC) under Article 22 EU Merger Regulation (EUMR) to examine a transaction that does not have a European dimension, but which is the subject of a referral request made by a Member State - even if the transaction is not notifiable in that Member State. Illumina shares gained as much as 6.6%, the most intraday since Aug. 24, after the EU decision. "The European Commission has renewed and adjusted, under the EU Merger Regulation, the interim measures that ensure that Illumina and GRAIL. | The European Commission's (EC) decision to block Illumina's acquisition of Grail marks the dawn of a new era for acquisitions of startups with innovation potential. To learn more, visit www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube. Address of host server location: 5200 Illumina Way, San Diego, CA 92122 U.S.A. All trademarks are the property of Illumina, Inc. or their respective owners. The company is reviewing the Commission's order and intends to appeal the decision. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on Illumina's financial condition, results of operations, credit rating or liquidity. At the same time, Illumina has challenged the jurisdiction of the EC in the General Court of the European Union and expects a decision by early 2022. San Diego-based Illumina said it is reviewing the. Follow the European Commission. [7] Illuminas[8] and GRAILs[9] appeals against the ECs interim measures are pending before the General Court. Illumina announced that it would hold GRAIL as a separate company during the ECs ongoing regulatory review. 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