Jazz Pharmaceuticals plc

Current report

We may not realize the anticipated benefits from our acquisitions, including the Actio Acquisition.

Current report

Our ability to realize the anticipated benefits from our acquisitions, including the Actio Acquisition, is subject to numerous risks and uncertainties. The success of any acquisition will depend in part, on our ability to successfully integrate the acquired businesses, assets, products, product candidates, technologies and operations into our existing business and to achieve the anticipated strategic, operational and financial benefits of such acquisitions. The anticipated benefits of our acquisitions are based on assumptions and expectations that may prove to be inaccurate or incomplete. In addition, difficulties may arise during the process of combining the operations of acquired businesses that could result in the failure to achieve anticipated revenue, delays or failures in the development, regulatory approval or commercialization of product candidates, the loss of key employees that may be difficult to replace in the very competitive pharmaceutical field, the failure to harmonize the companies’ corporate cultures, the disruption of ongoing businesses or inconsistencies in standards, controls, procedures and policies that adversely affect our ability to maintain relationships with suppliers, collaboration partners, clinical trial investigators or managers of our clinical trials. Acquisitions may also involve unexpected costs, liabilities, regulatory or legal risks, intellectual property disputes, or the need for additional investments and resources beyond those originally anticipated. As a result, the anticipated benefits of any acquisition may not be realized within the expected timeframe, or at all, and the costs associated with an acquisition may exceed our expectations, any of which could materially adversely affect our business, financial conditions, results of operations and growth prospects.

Current report

On September 15, 2026, we completed the Actio Acquisition for an upfront payment of $820.0 million, net of cash acquired, with the potential for additional payments of up to $500.0 million upon the achievement of certain regulatory and commercial milestones, for a total potential consideration of $1.3 billion. As a result, Actio became our wholly owned subsidiary. Our ability to realize the anticipated benefits of the Actio Acquisition will depend, in large part, on the successful development, receipt of regulatory approvals for and potential commercialization of ABS-1230 (JZP6979), which we acquired in the Actio Acquisition. ABS-1230 (JZP6979) may not be successfully developed, receive regulatory approval or be commercialized, may not achieve its anticipated commercial potential, or may require significantly greater resources and investments than originally anticipated.

Current report

In connection with the Actio Acquisition, we assumed a trade secret and breach of contract lawsuit brought by Praxis against Actio and its co-founder and Former CEO, Dr. Goldstein, in the U.S. District Court for the District of Delaware relating to certain KCNT1 inhibitor compounds. The complaint alleges, among other things, that Dr. Goldstein breached a Master Advisory Agreement with Praxis and that Actio and Dr. Goldstein misappropriated Praxis’ trade secrets relating to certain KCNT1 inhibitor compounds. Praxis seeks declaratory relief, injunctive relief, assignment of intellectual property allegedly derived from Praxis’ confidential and trade secret information, unspecified compensatory and exemplary damages, attorneys’ fees and costs, and an accounting and disgorgement of defendants’ alleged unjust enrichment. Although we intend to vigorously defend against these claims, intellectual property and trade secret disputes are inherently unpredictable and costly. An unfavorable ruling or settlement could result in substantial financial liabilities, require licensing arrangements on unfavorable terms, or result in an injunction or assignment of intellectual property that limits or precludes our ability to develop and commercialize ABS-1230 (JZP6979) or other acquired KCNT1 inhibitor assets, which would severely impair the expected value of the Actio Acquisition. For additional information regarding this litigation, see Note 10, Commitments and Contingencies—Legal Proceedings of the Notes to Condensed Consolidated Financial Statements, included in Part I of this Quarterly Report on Form 10-Q.

Current report

We have incurred, and may in the future incur, substantial costs as a result of litigation or other proceedings relating to patents, other intellectual property rights and related matters, and we may be unable to protect our rights to, or commercialize, our products.

Current report

Our ability, and that of our partners, to successfully commercialize any approved products will depend, in part, on our ability to obtain patents, enforce those patents and operate without infringing the proprietary rights of third parties. If we choose to go to court to stop a third party from infringing our patents, our licensed patents or our partners’ patents, that third party has the right to ask the court or an administrative agency to rule that these patents are invalid and/or should not be enforced. For example, we are pursuing patent infringement proceedings in Germany initiated by Chimerix against a supplier in contravention of certain patents acquired in connection with the Chimerix Acquisition. These lawsuits and administrative proceedings are expensive and consume time and other resources, and we may not be successful in these proceedings or in stopping infringement. In addition, the IPR or a post-grant review process under the Leahy-Smith America Invents Act permits any person, whether they are accused of infringing the patent at issue or not, to challenge the validity of certain patents through a proceeding before the PTAB.

Current report

There is a risk that a court could decide that our patents or certain claims in our patents are not valid or infringed, and that we do not have the right to stop a third party from using the inventions covered by those claims. In addition, the PTAB may invalidate a patent, as happened with six of our patents covering the Xywav and Xyrem REMS that were invalidated through the IPR process. In addition, even if we prevail in establishing that another product infringes a valid claim of one of our patents, a court may determine that we can be compensated for the infringement in damages, and refuse to issue an injunction. As a result, we may not be entitled to stop another party from infringing our patents for their full term.

Current report

Litigation involving patent matters is frequently settled between the parties, rather than continuing to a court ruling. The FTC has publicly stated that, in its view, certain types of agreements between branded and generic pharmaceutical companies related to the settlement of patent litigation or the manufacture, marketing and sale of generic versions of branded drugs violate the antitrust laws and has commenced investigations and brought actions against some companies that have entered into such agreements. In particular, the FTC has expressed its intention to take aggressive action to challenge settlements that include an alleged transfer of value from the brand company to the generic company (so-called “pay for delay” patent litigation settlements). The U.S. Congress and state legislatures have also identified pharmaceutical patent litigation settlements as potential impediments to generic competition and have introduced, and in states like California passed, legislation to regulate them. Third party payors have also challenged such settlements on the grounds that they increase drug prices. Because there is currently no precise legal standard with respect to the lawfulness of such settlements, many pharmaceutical companies, including us, have faced extensive litigation over whether patent litigation settlements they have entered into are reasonable and lawful. From June 2020 to May 2022, several lawsuits were filed on behalf of purported direct and indirect Xyrem purchasers, alleging that the patent litigation settlement agreements we entered with Hikma and other ANDA filers violate state and federal antitrust and consumer protection laws. As of October 2025, we have resolved the entirety of these antitrust lawsuits. It is possible that additional lawsuits will be filed against us making similar or related allegations. We cannot predict the outcome of any potential additional lawsuits; however, if the plaintiffs were to be successful in their claims, they may be entitled to injunctive relief or we may be required to pay significant monetary damages, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Current report

Parties to such settlement agreements in the U.S. are required by law to file the agreements with the FTC and the DOJ for review. Accordingly, we have submitted our patent litigation settlement agreements to the FTC and the DOJ for review. We may receive formal or informal requests from the FTC regarding our ANDA litigation settlements, and there is a risk that the FTC may commence a formal investigation or action against us, which could divert the attention of management and cause us to incur significant costs, regardless of the outcome. Any claim or finding that we or our business partners have failed to comply with applicable laws and regulations could be costly to us and have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Current report

A third party may claim that we or our manufacturing or commercialization partners are using inventions covered by the third party’s patent rights, or that we or such partners are infringing, misappropriating or otherwise violating other intellectual property rights, and may go to court to stop us from engaging in our normal operations and activities, including making or selling our products. For example, on October 14, 2025, Praxis filed a lawsuit in the U.S. District Court for the District of Delaware against Actio and David B. Goldstein, Ph.D., Actio's co-founder and former CEO. The complaint alleges, among other things, that Dr. Goldstein breached a Master Advisory Agreement with Praxis and that Actio and Dr. Goldstein misappropriated Praxis’ trade secrets relating to certain KCNT1 inhibitor compounds. Praxis seeks declaratory relief, injunctive relief, assignment of intellectual property allegedly derived from Praxis’ confidential and trade secret information, unspecified compensatory and exemplary damages, attorneys’ fees and costs, and an accounting and disgorgement of defendants’ alleged unjust enrichment.

Current report

On December 5, 2025, defendants filed a joint motion to dismiss the complaint, which the U.S. District Court for the District of Delaware denied on September 3, 2026. On September 15, 2026, in connection with the Actio Acquisition, we assumed Actio’s position as a defendant in this action, together with other rights and liabilities related to the acquired assets. On September 24, 2026, we filed our answer to the complaint and affirmative defenses. Trial in this matter is scheduled to begin July 31, 2028. Lawsuits such as these are costly and could affect our results of operations and divert the attention of management and development personnel. There is a risk that a court could decide that we or our partners are infringing, misappropriating or otherwise violating third party patent or other intellectual property rights, which could be very costly to us and have a material adverse effect on our business. If we are sued for patent infringement, we would need to demonstrate that our products or methods do not infringe the patent claims of the relevant patent and/or that the patent claims are invalid or unenforceable, which we may not be able to do.

Current report

If we were found to infringe upon a patent or other intellectual property right, if we failed to obtain or renew a license under a patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. In addition, if we have declined or failed to enter into a valid assignment agreement for any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected.

Current report

Litigation, whether filed by us or against us, can be expensive and time consuming to defend and divert management’s attention and resources. Our competitive position could suffer as a result.

Current report

The following table summarizes purchases of our ordinary shares made by or on behalf of us or any of our “affiliated purchasers” as defined in Rule 10b-18(a)(3) under the Securities Exchange Act of 1934, as amended, during each fiscal month during the three-month period ended September 30, 2026:

Current report

This table does not include ordinary shares that we withheld in order to satisfy tax withholding requirements in connection with the vesting and release of restricted stock units. All the ordinary shares reported in this column were purchased pursuant to our publicly announced share Repurchase Program.

Current report

Average price paid per ordinary share includes brokerage commissions.

Current report

The dollar amount shown represents, as of the end of each period, the approximate dollar value, in millions, of ordinary shares that may yet be purchased under the Repurchase Program, exclusive of any brokerage commissions.

Previous report

Item 1A. Risk Factors

Previous report

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Current report — wording carried from elsewhere

In October 2026, our board of directors approved a new share repurchase program to repurchase ordinary shares having an aggregate purchase price of $500.0 million, exclusive of any brokerage commissions.

Previous report — wording carried elsewhere

The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under our outstanding credit agreement and the indenture for our Secured Notes, corporate and regulatory requirements, and market conditions. The Repurchase Program may be modified, suspended or discontinued at any time without our prior notice.