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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Ireland
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98-1032470
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of each class
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Name of each exchange on which registered
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Ordinary shares, nominal value $0.0001 per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
x
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Accelerated filer
¨
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Non-accelerated filer
¨
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Smaller reporting company
¨
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(Do not check if a smaller reporting company)
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Page
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PART I
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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PART II
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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PART III
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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PART IV
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Item 15.
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Item 16.
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Item 1.
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Business
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•
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Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, and currently marketed for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
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Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
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Defitelio
®
(defibrotide sodium)
, a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, or SOS, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio
®
(defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy.
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•
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Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;
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Acquiring or licensing rights to clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
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Pursuing targeted development of post-discovery differentiated product candidates.
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JZP-110.
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Xyrem
.
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JZP-507.
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JZP-258.
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Vyxeos (CPX-351).
Through the acquisition of Celator Pharmaceuticals, Inc., or Celator, in July 2016, or the Celator Acquisition, we acquired worldwide development and commercialization rights to Vyxeos, an investigational
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Defibrotide.
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Asparaginase Programs.
We are pursuing activities related to the development of improved products for patients with ALL, including an effective, well-tolerated and long-acting recombinant crisantaspase that could offer clinically meaningful benefits compared to Erwinaze. In addition, in July 2016, we entered into an agreement with Pfenex Inc., or Pfenex, under which Pfenex granted us worldwide rights to develop and commercialize multiple early-stage hematology product candidates. The agreement includes an option for us to negotiate a license for a recombinant pegaspargase product candidate with Pfenex.
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Xyrem
. Xyrem is the only product approved by the FDA and currently marketed in the U.S. for the treatment of both cataplexy and EDS in patients with narcolepsy. On January 17, 2017, the FDA announced approval of Roxane’s ANDA for a generic version of Xyrem. The FDA’s letter approving Roxane’s ANDA notes that Roxane was the first ANDA applicant and is eligible for 180 days of generic drug exclusivity for its generic product. Roxane’s approval also includes a waiver that permits Roxane to use a separate REMS program from Xyrem, on the condition that Roxane’s waiver-granted REMS system be open to all future sponsors of ANDAs or NDAs for sodium oxybate products. On January 19, 2017, the FDA tentatively approved two additional ANDAs for generic versions of Xyrem, one for Amneal and one for Ranbaxy, and we believe that it is likely that the FDA will approve or tentatively approve additional ANDAs. However, the timing of any potential commercial launch of a generic version of Xyrem is uncertain. We do not believe a launch by an ANDA filer is likely to occur prior to either a date agreed in a settlement agreement between us and such ANDA filer or a District Court, or potentially an appellate court, decision in our ongoing patent litigation. For further discussion of ongoing patent litigation and related proceedings, see “Legal Proceedings” in Part I, Item 3 of this Annual Report on Form 10-K and the risk factor under the heading “
The approval and launch of a generic version of Xyrem or other sodium oxybate products that compete with Xyrem would adversely affect sales of Xyrem
” in Part I, Item 1A of this Annual Report on Form 10‑K. For further discussion regarding the risks associated with FDA approval of the Roxane ANDA, tentative approval of the Amneal and Ranbaxy ANDAs, potential approval or tentative approval of additional ANDAs and the potential launch of a generic version of Xyrem, or the approval and launch of other sodium oxybate products that compete with Xyrem, as well as other risks and challenges we face with respect to Xyrem, see “Business-Government Regulation-
The Hatch-Waxman Act
” in this Part I, Item 1 and the risk factors under the headings “Risks Related to Xyrem and the Significant Impact of Xyrem Sales” and
“Risks Related to Our Intellectual Property” in Part I, Item 1A of this Annual Report on Form 10-K.
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•
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As alternatives to Xyrem, cataplexy is often treated with tricyclic antidepressants and selective serotonin reuptake inhibitors, or SSRIs, or selective norepinephrine reuptake inhibitors, or SNRIs, even though these products are not approved by the FDA for the treatment of cataplexy. Tricyclic antidepressants are a class of antidepressant drugs first
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Erwinaze
. Erwinaze is a biologic product used in conjunction with chemotherapy and is indicated for patients with ALL who have developed hypersensitivity to
E. coli
-derived asparaginase. While there is currently no direct competition to Erwinaze to treat ALL patients with hypersensitivity to
E. coli
-derived asparaginase, other companies have developed or are developing new treatments for ALL, including new asparaginase treatments that could reduce the rate of hypersensitivity in patients with ALL, and new treatment protocols are being developed for ALL that may not include asparaginase-containing regimens. For example, a number of companies are developing new immunotherapy treatments for relapsed or refractory ALL patients, including one treatment that was recently approved. Any potential new treatment could reduce the market for Erwinaze. As a biologic product, Erwinaze also faces potential competition from biosimilar products.
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Defitelio
.
Defitelio is the only approved treatment in the U.S. for the treatment of adult and pediatric patients with VOD, also known as SOS, with renal or pulmonary dysfunction following HSCT and the only approved treatment in the EU for severe VOD in adults and children undergoing HSCT. Various anti-clotting strategies have been tried by researchers in patients with VOD with mixed results, including Activase (alteplase), a recombinant tissue plasminogen activator marketed by Genentech, Inc., generic heparin sodium injection and Thrombate III (antithrombin III (human)), marketed by Grifols Therapeutics, Inc. While there is currently no direct competition to Defitelio to treat severe VOD, changes in the types of conditioning regimens used as part of HSCT may affect the incidence rate of VOD and demand for Defitelio.
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Vyxeos
. AML, a cancer indication for which we intend to commercialize Vyxeos, has established therapies. A key consideration in the treatment of AML patients is the patient’s suitability for chemotherapy. The patient population studied in the Vyxeos Phase 3 clinical trial included AML patients deemed able to tolerate chemotherapy. There are existing options for the treatment of newly-diagnosed AML patients who can tolerate chemotherapy, such as cytarabine in combination with an anthracycline (i.e., daunorubicin), known as 7+3. In addition, we are aware of several other products in development for use as treatment options for AML patients, such as targeted agents (FLT-3, IDH-1, IDH-2, CD-33, CAR T-cell). Some of the patient populations being studied for these products in development overlap with the patient population studied in the Vyxeos Phase 3 clinical trial.
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the existence of competing or alternative products in the marketplace, including generic competition, and the relative price of those products;
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the efficacy, safety and reliability of our products and product candidates compared to competing or alternative products;
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product acceptance by physicians, other health care providers and patients;
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our ability to comply with applicable laws, regulations and regulatory requirements with respect to the commercialization of our products, including any changes to, or uncertainties around, regulatory restrictions;
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protection of our proprietary rights;
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obtaining reimbursement for our products in approved indications;
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our ability to complete clinical development and obtain regulatory approvals for our product candidates, and the timing and scope of regulatory approvals;
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our ability to provide a reliable supply of commercial quantities of a product to the market; and
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our ability to recruit, retain and develop skilled employees, including sales and marketing and clinical development employees.
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Xyrem.
We have 22 patents relating to Xyrem that expire at various times from December 2019 to March 2033, of which 18 are listed in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” or Orange Book. These patents relate to Xyrem’s stable and microbially resistant formulation, its manufacturing process, its method of use, including its restricted distribution system, and its method of administration. Of the patents listed in the Orange Book, five are formulation patents expiring between December 2019 and July 2020; seven are REMS patents, expiring between December 2022 and June 2024; three are method of use patents covering Xyrem’s use in narcolepsy, which expire in December 2019; and three are method of administration patents relating to a drug-drug interaction, or DDI, between Xyrem and divalproex sodium expiring in March 2033. Four patents are not listed in the Orange Book but also relate to Xyrem: two for methods for making the formulation expiring December 2019, one for a distribution system expiring June 2024 and one for method of administration expiring March 2033. We have received a pediatric written request from the FDA, and we intend to submit the results of a pediatric clinical study in response to this request. If the FDA determines that the submission meets the terms and conditions of the written request, then six months of pediatric exclusivity will be added to the term of each patent listed for Xyrem in the Orange Book. A Xyrem formulation patent has issued in multiple non-U.S. countries and will expire in December 2019. In addition to our issued patents, we have patent applications relating to Xyrem pending in the U.S. and other countries.
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Defitelio
. The unique process of deriving defibrotide from porcine DNA is extensive and uses both chemical and biological processes that rely on complex characterization methods. We have a portfolio of U.S. and non-U.S. patents and patent applications relating to various compositions, methods of use and methods of characterization, which will expire at various times between April 2017 and June 2035. None of these patents are listed in the Orange Book.
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Erwinaze
. Erwinaze has no patent protection. It was awarded orphan drug exclusivity for the treatment of ALL in the U.S. until November 2018, and we believe that it is protected by exclusivity that prevents approval of a biosimilar in the U.S. through late 2023 under the BPCIA. For more details, see “Business—Government Regulation—Orphan Drug and Other Exclusivities” in this Part I, Item 1.
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Vyxeos.
Vyxeos and its related technologies are claimed in multiple U.S. and non-U.S. patents. We acquired rights to Vyxeos, the CombiPlex technology platform and related technologies in the Celator Acquisition. We have a portfolio of U.S. and non-U.S. patents and patent applications relating to Vyxeos, including three U.S. formulation patents expiring between September 2027 and April 2029 and two U.S. patents covering the CombiPlex technology platform expiring in January 2027, subject to any patent term extensions.
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JZP-110
. JZP-110 and its associated uses are claimed in multiple U.S. and non-U.S. patents and patent applications. We acquired rights to JZP-110 from Aerial in January 2014, including Aerial’s patent rights relating to JZP-110, other than in certain jurisdictions in Asia where SK retains rights. One of the U.S. composition of matter patents expired in September 2015. Two U.S. method of use patents covering treatment of sleep-related conditions will expire in June 2026 and August 2027, subject to any patent term extension.
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JZP-507 and JZP-258.
Certain patents and patent applications relating to Xyrem cover JZP-507 and JZP-258. In addition, JZP-507 and JZP-258 are claimed in formulation patents that will expire in January 2033.
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Item 1A.
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Risk Factors
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the potential commercialization of a generic version of Xyrem, including in connection with the recent approval by the U.S. Food and Drug Administration, or FDA, of an abbreviated new drug application, or ANDA, for a generic version of Xyrem, as well as tentative approval of two additional ANDAs;
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the potential U.S. introduction of an alternative product to Xyrem for treating cataplexy and/or excessive daytime sleepiness, or EDS, in narcolepsy;
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changes to, increases of or uncertainties around regulatory restrictions, including changes to our Xyrem risk evaluation and mitigation strategy, or REMS, particularly in light of the FDA’s waiver of the single shared system REMS requirement for sodium oxybate and approval of a separate generic sodium oxybate REMS;
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any increase in pricing pressure from, or restrictions on reimbursement imposed by, third party payors;
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changes in healthcare laws and policy, including changes in requirements for patient assistance programs, rebates, reimbursement and coverage by federal healthcare programs, and changes resulting from increased scrutiny on pharmaceutical pricing by government entities;
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operational disruptions at the Xyrem central pharmacy or any failure to comply with our REMS obligations to the satisfaction of the FDA;
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any supply or manufacturing problems, including any problems with our sole source Xyrem API provider;
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continued acceptance of Xyrem by physicians and patients, even in the face of negative publicity that surfaces from time to time;
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changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem; and
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our U.S.-based sodium oxybate and Xyrem suppliers’ ability to obtain sufficient quotas from the U.S. Drug Enforcement Administration, or DEA, to satisfy our needs for Xyrem.
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the continued acceptance of Defitelio in the U.S. by hospital pharmacy and therapeutics committees and the continued availability of adequate coverage and reimbursement by government programs and third party payors;
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the lack of experience of U.S. physicians in diagnosing and treating VOD, particularly in adults, and the possibility that physicians may delay initiation of treatment or terminate treatment before the end of the recommended dosing schedule;
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our ability to successfully maintain or grow sales of Defitelio in Europe;
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delays or problems in the supply or manufacture of the product;
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the limited size of the population of VOD patients who are indicated for treatment with Defitelio (particularly if changes in HSCT treatment protocols reduce the incidence of VOD diagnosis);
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our ability to meet the post-marketing commitments and requirements imposed by the FDA in connection with its approval of our NDA for Defitelio; and
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our ability to obtain marketing approval in other countries and to develop the product for additional indications.
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our ability to differentiate Vyxeos from other liposomal chemotherapies and generically available chemotherapy combinations with which physicians and treatment centers are more familiar;
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the need to establish pricing and reimbursement support for Vyxeos in the event we are able to obtain marketing approval for Vyxeos in the U.S. or in other countries;
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the acceptance of Vyxeos in the U.S. and other countries by hospital pharmacy and therapeutics committees and the availability of adequate coverage and reimbursement by government programs and third party payors;
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delays or problems in the supply or manufacture of the product, including with respect to the requirement of the third parties upon which we rely to manufacture Vyxeos and its active pharmaceutical ingredients, or APIs, obtain the approval of the FDA and/or other regulatory authorities to manufacture Vyxeos and to manufacture sufficient quantities of Vyxeos in accordance with applicable specifications; and
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the limited size of the population of high-risk AML patients who may potentially be indicated for treatment with Vyxeos, particularly given the ongoing clinical trials by other companies with the same patient population.
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the increased complexity and costs inherent in managing international operations;
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diverse regulatory, financial and legal requirements, and any future changes to such requirements, in one or more countries where we are located or do business;
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country-specific tax, labor and employment laws and regulations;
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applicable trade laws, tariffs, export quotas, custom duties or other trade restrictions and any changes to them;
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challenges inherent in efficiently managing employees in diverse geographies, including the need to adapt systems, policies, benefits and compliance programs to differing labor and other regulations, as well as maintaining positive interactions with unionized employees in one of our international locations;
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liabilities for activities of, or related to, our international operations, products or product candidates;
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changes in currency rates; and
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regulations relating to data security and the unauthorized use of, or access to, commercial and personal information.
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the clinical indications for which a product is approved, including any restrictions placed upon the product in connection with its approval, such as a REMS, patient registry or labeling restrictions;
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the prevalence of the disease or condition for which the product is approved and its diagnosis, and the severity of side effects;
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acceptance by physicians and patients of each product as a safe and effective treatment;
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availability of sufficient product inventory to meet demand, particularly with respect to Erwinaze;
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physicians’ decisions relating to treatment practices based on availability of product inventory;
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perceived advantages over alternative treatments;
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relative convenience and ease of administration;
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physician and patient assessment of the burdens associated with obtaining or maintaining the certifications required under the Xyrem REMS;
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the cost of treatment in relation to alternative treatments, including generic products;
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the extent to which the product is approved for inclusion on formularies of hospitals and managed care organizations;
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the conditions for reimbursement required by, and appropriate pricing and availability of reimbursement from, third party payors; and
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the availability of financial or other assistance for patients who are uninsured or underinsured.
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we are unable to obtain and maintain adequate funding to complete the development of, obtain regulatory approval for and commercialize an acquired product candidate;
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a product candidate proves not to be safe or effective in later clinical trials;
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a product fails to reach its forecasted commercial potential as a result of pricing pressures;
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we experience negative publicity regarding actual or potential future price increases for that product or otherwise; or
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the integration of a product or product candidate gives rise to unforeseen difficulties and expenditures.
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high acquisition costs;
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the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions;
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the potential disruption of our historical core business;
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the strain on, and need to continue to expand, our existing operational, technical, financial and administrative infrastructure;
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the difficulties in assimilating employees and corporate cultures;
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the failure to retain key managers and other personnel;
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the challenges in controlling additional costs and expenses in connection with and as a result of any acquisition;
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the need to write down assets or recognize impairment charges;
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the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and
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any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates.
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delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;
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delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;
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delays or failures in reaching agreement on acceptable terms with prospective study sites;
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delays or failures in obtaining approval of our clinical trial protocol from an institutional review board, also known as Ethics Committees in Europe, to conduct a clinical trial at a prospective study site;
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delays or failures in recruiting patients to participate in a clinical trial;
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failure of our clinical trials and clinical investigators to be in compliance with the FDA and other regulatory agencies’ good clinical practice guidelines;
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unforeseen safety issues, including negative results from ongoing preclinical studies and clinical trials and adverse events associated with product candidates;
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inability to monitor patients adequately during or after treatment;
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difficulty monitoring multiple study sites;
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difficulty identifying or enrolling eligible patients, in some cases based on the number of clinical trials with enrollment criteria targeting the same patient population;
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failure of our third party clinical trial managers to satisfactorily perform their contractual duties, comply with regulations or meet expected deadlines; or
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insufficient funds to complete the trials.
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others may independently develop similar or alternative products without infringing our intellectual property rights, such as products that are not covered by the claims of our patents, or for which we do not have adequate exclusive rights under our license agreements;
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we or our licensors or partners might not have been the first to invent or file, as appropriate, subject matters covered by our issued patents or pending patent applications or the pending patent applications or issued patents of our licensors or partners;
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our pending patent applications may not result in issued patents;
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our issued patents and the issued patents of our licensors or partners may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
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our issued patents and the issued patents of our licensors or partners may be vulnerable to legal challenges as a result of changes in applicable law;
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we may not develop additional proprietary products that are patentable; or
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the patents of others may have an adverse effect on our business.
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limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;
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limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;
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require us to use a substantial portion of our cash flow from operations to make debt service payments;
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limit our flexibility to plan for, or react to, changes in our business and industry;
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result in dilution to our existing shareholders in the event exchanges of our 2021 Notes are settled in our ordinary shares;
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place us at a competitive disadvantage compared to our less leveraged competitors; and
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increase our vulnerability to the impact of adverse economic and industry conditions.
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incur or assume liens or additional debt or provide guarantees in respect of obligations of other persons;
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issue redeemable preferred stock;
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pay dividends or distributions or redeem or repurchase capital stock;
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prepay, redeem or repurchase certain debt;
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make loans, investments, acquisitions (including acquisitions of exclusive licenses) and capital expenditures;
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enter into agreements that restrict distributions from our subsidiaries;
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sell assets and capital stock of our subsidiaries;
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enter into certain transactions with affiliates; and
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consolidate or merge with or into, or sell substantially all of our assets to, another person.
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the revenues from our commercial products, which may be affected by many factors, including the extent of generic or other competition for Xyrem or our other products;
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the costs of our commercial operations;
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the costs of integration activities related to any future strategic transactions we may engage in;
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the cost of acquiring and/or in-licensing any new products and product candidates;
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the scope, rate of progress, results and costs of our development and clinical activities;
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the cost and timing of obtaining regulatory approvals and of compliance with laws and regulations;
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the cost of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
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the cost of investigations, litigation and/or settlements related to regulatory oversight and third party claims; and
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changes in laws and regulations, including, for example, healthcare reform legislation.
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impose advance notice requirements for shareholder proposals and nominations of directors to be considered at shareholder meetings;
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stagger the terms of our board of directors into three classes;
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require the approval of a supermajority of the voting power of the shares of our share capital entitled to vote generally at a meeting of shareholders to amend or repeal our articles of association; and
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permit our board of directors to issue one or more series of preferred shares with rights and preferences, as our shareholders may determine by ordinary resolution.
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Item 1B.
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Unresolved Staff Comments
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Item 2.
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Properties
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Item 3.
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Legal Proceedings
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Item 4.
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Mine Safety Disclosures.
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Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
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High
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Low
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Calendar Quarter—2015
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First Quarter
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$
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190.17
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$
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155.06
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Second Quarter
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$
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191.01
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$
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165.00
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Third Quarter
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$
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194.73
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$
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121.12
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Fourth Quarter
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$
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151.28
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$
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117.26
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Calendar Quarter—2016
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First Quarter
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$
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139.55
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$
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108.50
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Second Quarter
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$
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160.00
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$
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129.00
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Third Quarter
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$
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153.98
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$
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117.34
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Fourth Quarter
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$
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126.36
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$
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95.80
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(1)
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This section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by reference into any of our filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, or Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
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(2)
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Information used in the graph was obtained from Research Data Group, Inc.
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Total Number of Shares Purchased (1)
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Average Price Paid per Share (2)
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Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (3)
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Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs (4)
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October 1 - October 31, 2016
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
November 1 - November 30, 2016
|
22,500
|
|
|
$
|
110.40
|
|
|
22,500
|
|
|
$
|
297,516,445
|
|
December 1 - December 31, 2016
|
152,300
|
|
|
$
|
105.02
|
|
|
152,300
|
|
|
$
|
281,524,820
|
|
Total
|
174,800
|
|
|
$
|
105.71
|
|
|
174,800
|
|
|
|
(1)
|
This table does not include ordinary shares that we withheld in order to satisfy minimum tax withholding requirements in connection with the vesting of restricted stock units.
|
(2)
|
Average price paid per share includes brokerage commissions.
|
(3)
|
The ordinary shares reported in the table above were purchased pursuant to our publicly announced share repurchase program. In November 2016, we announced that our board of directors authorized the use of up to $300 million to repurchase our ordinary shares. This authorization has no expiration date.
|
(4)
|
The dollar amount shown represents, as of the end of each period, the approximate dollar value of ordinary shares that may yet be purchased under our publicly announced share repurchase program, exclusive of any brokerage commissions. 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 credit agreement, corporate and regulatory requirements and market conditions, and may be modified, suspended or otherwise discontinued at any time without prior notice.
|
Item 6.
|
Selected Financial Data
|
|
As of December 31,
|
||||||||||||||||||
|
2016(1)
|
|
2015
|
|
2014(2)
|
|
2013
|
|
2012(3)
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and investments
|
$
|
425,963
|
|
|
$
|
988,785
|
|
|
$
|
684,042
|
|
|
$
|
636,504
|
|
|
$
|
387,196
|
|
Working capital
|
490,663
|
|
|
1,031,025
|
|
|
799,044
|
|
|
660,589
|
|
|
360,034
|
|
|||||
Total assets
(4)(5)
|
4,800,227
|
|
|
3,332,612
|
|
|
3,308,617
|
|
|
2,225,900
|
|
|
1,952,014
|
|
|||||
Long-term debt, current and non-current
(4)
|
2,029,625
|
|
|
1,188,444
|
|
|
1,313,161
|
|
|
539,436
|
|
|
443,298
|
|
|||||
Retained earnings (accumulated deficit)
|
528,907
|
|
|
302,686
|
|
|
34,704
|
|
|
18,532
|
|
|
(61,296
|
)
|
|||||
Total Jazz Pharmaceuticals plc shareholders’ equity
|
1,877,339
|
|
|
1,598,646
|
|
|
1,371,144
|
|
|
1,295,534
|
|
|
1,121,292
|
|
(1)
|
On May 27, 2016, we entered into a definitive merger agreement with Celator Pharmaceuticals, Inc., or Celator, pursuant to which we made a cash tender offer of
$30.25
per share for all of the outstanding shares of Celator’s common stock. On July 12, 2016, we completed the acquisition of Celator, which acquisition we refer to in this report as the Celator Acquisition, under the terms of the merger agreement. Celator became an indirect wholly-owned subsidiary of Jazz Pharmaceuticals plc, and each share of Celator common stock then outstanding (other than shares owned by us or Celator) was converted into the right to receive
$30.25
, the same price per share offered in the tender offer. The aggregate cash consideration for the Celator Acquisition was
$1.5 billion
. The results of operations of the acquired Celator business, along with the estimated fair values of the assets acquired and liabilities assumed in the Celator Acquisition, have been included in our consolidated financial statements since the closing of the Celator Acquisition on July 12, 2016. On July 12, 2016, we entered into an amendment to our 2015 credit agreement, which amended agreement we refer to in this report as our amended credit agreement, that provides for a revolving credit facility of
$1.25 billion
, which replaced our prior revolving credit facility of
$750.0 million
, and a
$750.0 million
term loan facility. We used the proceeds of
$1.0 billion
of loans under the revolving credit facility, together with cash on hand, to fund the Celator Acquisition. The maturity date of both our revolving credit facility and term loan facility was extended from June 2020 to July 2021 pursuant to the amended credit facility.
|
(2)
|
On January 23, 2014, pursuant to a tender offer, we became the indirect majority shareholder of Gentium S.r.l., or Gentium, acquiring control of Gentium on that date. In February 2014, we completed a subsequent offering period of the tender offer, resulting in total purchases pursuant to the tender offer of approximately
98%
of the fully diluted voting securities of Gentium. As of December 31, 2015, we had acquired the remaining
2%
interest in Gentium for cash consideration of
$17.9 million
, resulting in an aggregate acquisition cost to us of
$994.1 million
, comprising cash payments of
$1,011.2 million
offset by proceeds from the exercise of Gentium share options of
$17.1 million
. The results of operations of the acquired Gentium business, along with the estimated fair values of the assets acquired and liabilities assumed in the transaction, have been included in our consolidated financial statements since the completion of the acquisition of Gentium on January 23, 2014, which is referred to in this report as the Gentium Acquisition. In connection with the Gentium Acquisition, on January 23, 2014, we entered into a second amendment to the credit agreement we entered into in June 2012, or the previous credit agreement. We used the proceeds from incremental term loans of $350.0 million and $300.0 million of loans under the revolving credit facility provided for under the previous credit agreement, together with cash on hand, to finance the Gentium Acquisition. In August 2014, we completed a private placement of $575.0 million aggregate principal amount of 1.875% exchangeable senior notes due 2021, or the 2021 Notes, resulting in net proceeds to us, after debt issuance costs, of $558.9 million. We used a portion of the net proceeds from the issuance of the 2021 Notes to repay all then outstanding borrowings under the revolving credit facility provided for under the previous credit agreement.
|
(3)
|
On January 18, 2012, the businesses of Jazz Pharmaceuticals, Inc. and Azur Pharma were combined in the Azur Merger pursuant to which all outstanding shares of Jazz Pharmaceuticals, Inc.’s common stock were canceled and converted into the right to receive, on a one-for-one basis, our ordinary shares. Jazz Pharmaceuticals, Inc. was treated as the acquiring company in the Azur Merger for accounting purposes, and as a result, the historical consolidated financial statements of Jazz Pharmaceuticals, Inc. became our consolidated financial statements. On June 12, 2012, we completed our acquisition of EUSA Pharma Inc., or EUSA Pharma, which we refer to as the EUSA Acquisition. At the closing of the EUSA Acquisition, we paid
$678.4 million
in cash, and agreed to make an additional contingent payment of
$50.0 million
in cash if Erwinaze achieved net sales in the U.S. of
$124.5 million
or more in 2013. In 2013, net sales of Erwinaze in the U.S. exceeded
$124.5 million
and as a result, we made this payment in 2014. The results of operations of the acquired Azur Pharma and EUSA Pharma businesses, along with the estimated fair values of the assets acquired and liabilities assumed in each transaction, are included in our consolidated financial statements since the effective dates of the Azur Merger and the
|
(4)
|
Effective January 1, 2016, we adopted Accounting Standards Update, or ASU, No. 2015-03 “Interest - Imputation of Interest” which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the debt liability instead of as an asset. The standard requires retrospective application. Prior period amounts for all years presented above were reclassified to conform to the current period presentation. Total assets and total long-term debt, current and non-current at December 31, 2015, 2014, 2013 and 2012 have been reduced by
$16.1 million
,
$29.3 million
,
$10.5 million
and
$13.5 million
, respectively, to reflect the adoption of ASU No. 2015-03.
|
(5)
|
The indirect effects of certain unrecognized tax benefits, previously classified within other non-current assets for all years presented above, have been reclassified to deferred tax assets, net, non-current and deferred tax liability, net, non-current to conform to current period presentation.
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, and marketed in the U.S. for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
|
•
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
|
•
|
Defitelio
®
(defibrotide sodium)
, a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, or SOS, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio
®
(defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy.
|
•
|
Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;
|
•
|
Acquiring or licensing rights to clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
|
•
|
Pursuing targeted development of post-discovery differentiated product candidates.
|
•
|
the potential commercialization of a generic version of Xyrem, including in connection with the recent approval by the FDA of ANDA for a generic version of Xyrem, as well as tentative approval of two additional ANDAs, as further described below;
|
•
|
the potential U.S. introduction of an alternative product to Xyrem for treating cataplexy and/or EDS in narcolepsy;
|
•
|
changes to, increases of or uncertainties around regulatory restrictions, including changes to our Xyrem REMS, particularly in light of the FDA’s waiver of the single shared systems REMS requirement for sodium oxybate and approval of a separate generic sodium oxybate REMS, as further described below;
|
•
|
any increase in pricing pressure from, or restrictions on reimbursement imposed by, third party payors;
|
•
|
changes in healthcare laws and policy, including changes in requirements for patient assistance programs, rebates, reimbursement and coverage by federal healthcare programs, and changes resulting from increased scrutiny on pharmaceutical pricing by government entities;
|
•
|
operational disruptions at the Xyrem central pharmacy or any failure to comply with our REMS obligations to the satisfaction of the FDA;
|
•
|
any supply or manufacturing problems, including any problems with our sole source Xyrem API provider;
|
•
|
continued acceptance of Xyrem by physicians and patients, even in the face of negative publicity that surfaces from time to time;
|
•
|
changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem; and
|
•
|
our U.S.-based sodium oxybate and Xyrem suppliers’ ability to obtain sufficient quotas from the U.S. Drug Enforcement Administration, or DEA, to satisfy our needs for Xyrem.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
the challenges of achieving and maintaining commercial success of our products;
|
•
|
delays or problems in the supply or manufacture of our products and product candidates, particularly with respect to certain products as to which we maintain limited inventories, our dependence on single source suppliers for most of our products, product candidates and APIs, and the requirement that we and our product suppliers be qualified by the FDA to manufacture product and comply with applicable manufacturing regulations;
|
•
|
the need to obtain and maintain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to healthcare cost containment and other austerity measures and pharmaceutical pricing in the U.S. and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the U.S. in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by government programs and third party payors;
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business;
|
•
|
the challenges of compliance with the requirements of the FDA, the DEA and comparable non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, patient assistance programs, adverse event reporting and product recalls or withdrawals;
|
•
|
the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates;
|
•
|
the inherent uncertainty associated with the regulatory approval process, especially as we continue to increase investment in our product pipeline development projects and undertake multiple planned NDA submissions for our product candidates;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, including risks associated with the Celator Acquisition, such as the challenges inherent in the integration of acquired businesses with our historical business, the increase in geographic dispersion among our centers of operation and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such transactions; and
|
•
|
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations, as a result of, among other things, the Celator Acquisition.
|
|
2016 (1)
|
|
Change
|
|
2015
|
|
Change
|
|
2014 (2)
|
||||||||
Product sales, net
|
$
|
1,477,261
|
|
|
12
|
%
|
|
$
|
1,316,819
|
|
|
13
|
%
|
|
$
|
1,162,716
|
|
Royalties and contract revenues
|
10,712
|
|
|
34
|
%
|
|
7,984
|
|
|
(21
|
)%
|
|
10,159
|
|
|||
Cost of product sales (excluding amortization and impairment of intangible assets)
|
105,386
|
|
|
3
|
%
|
|
102,526
|
|
|
(13
|
)%
|
|
117,418
|
|
|||
Selling, general and administrative
|
502,892
|
|
|
12
|
%
|
|
449,119
|
|
|
11
|
%
|
|
406,114
|
|
|||
Research and development
|
162,297
|
|
|
20
|
%
|
|
135,253
|
|
|
59
|
%
|
|
85,181
|
|
|||
Acquired in-process research and development
|
23,750
|
|
|
N/A(3)
|
|
|
—
|
|
|
N/A(3)
|
|
|
202,626
|
|
|||
Intangible asset amortization
|
101,994
|
|
|
4
|
%
|
|
98,162
|
|
|
(22
|
)%
|
|
126,584
|
|
|||
Impairment charges
|
—
|
|
|
N/A(3)
|
|
|
31,523
|
|
|
(20
|
)%
|
|
39,365
|
|
|||
Interest expense, net
|
61,942
|
|
|
9
|
%
|
|
56,917
|
|
|
8
|
%
|
|
52,713
|
|
|||
Foreign currency gain
|
(3,372
|
)
|
|
133
|
%
|
|
(1,445
|
)
|
|
(83
|
)%
|
|
(8,683
|
)
|
|||
Loss on extinguishment and modification of debt
|
638
|
|
|
(96
|
)%
|
|
16,815
|
|
|
N/A(3)
|
|
|
—
|
|
|||
Income tax provision
|
135,236
|
|
|
27
|
%
|
|
106,399
|
|
|
13
|
%
|
|
94,231
|
|
|||
Equity in net loss of investee
|
379
|
|
|
N/A(3)
|
|
|
—
|
|
|
N/A(3)
|
|
|
—
|
|
|||
Net loss attributable to noncontrolling interests
|
—
|
|
|
N/A(3)
|
|
|
(1
|
)
|
|
N/A(3)
|
|
|
(1,061
|
)
|
(1)
|
Our financial results include the financial results of the historical Celator business since the closing of the Celator Acquisition on July 12, 2016.
|
(2)
|
Our financial results include the financial results of the historical Gentium business since the closing of the Gentium Acquisition on January 23, 2014.
|
(3)
|
Comparison to prior period is not meaningful.
|
|
2016
|
|
Change
|
|
2015
|
|
Change
|
|
2014
|
||||||||
Xyrem
|
$
|
1,107,616
|
|
|
16
|
%
|
|
$
|
955,187
|
|
|
23
|
%
|
|
$
|
778,584
|
|
Erwinaze/Erwinase
|
200,678
|
|
|
(1
|
)%
|
|
203,261
|
|
|
2
|
%
|
|
199,665
|
|
|||
Defitelio/defibrotide
|
108,952
|
|
|
54
|
%
|
|
70,731
|
|
|
—
|
%
|
|
70,537
|
|
|||
Prialt® (ziconotide) intrathecal infusion
|
29,120
|
|
|
10
|
%
|
|
26,440
|
|
|
—
|
%
|
|
26,421
|
|
|||
Psychiatry
|
17,653
|
|
|
(52
|
)%
|
|
37,135
|
|
|
(9
|
)%
|
|
40,879
|
|
|||
Other
|
13,242
|
|
|
(45
|
)%
|
|
24,065
|
|
|
(48
|
)%
|
|
46,630
|
|
|||
Product sales, net
|
1,477,261
|
|
|
12
|
%
|
|
1,316,819
|
|
|
13
|
%
|
|
1,162,716
|
|
|||
Royalties and contract revenues
|
10,712
|
|
|
34
|
%
|
|
7,984
|
|
|
(21
|
)%
|
|
10,159
|
|
|||
Total revenues
|
$
|
1,487,973
|
|
|
12
|
%
|
|
$
|
1,324,803
|
|
|
13
|
%
|
|
$
|
1,172,875
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Clinical studies and outside services
|
$
|
100,165
|
|
|
$
|
63,079
|
|
|
41,769
|
|
|
Personnel expenses
|
47,969
|
|
|
39,515
|
|
|
38,228
|
|
|||
Milestone
|
750
|
|
|
25,000
|
|
|
—
|
|
|||
Other
|
13,413
|
|
|
7,659
|
|
|
5,184
|
|
|||
Total
|
$
|
162,297
|
|
|
$
|
135,253
|
|
|
$
|
85,181
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net cash provided by operating activities
|
$
|
590,536
|
|
|
$
|
531,943
|
|
|
$
|
407,606
|
|
Net cash used in investing activities
|
(1,749,300
|
)
|
|
(2,255
|
)
|
|
(1,067,649
|
)
|
|||
Net cash provided by (used in) financing activities
|
540,987
|
|
|
(214,323
|
)
|
|
711,034
|
|
|||
Effect of exchange rates on cash and cash equivalents
|
(5,045
|
)
|
|
(10,622
|
)
|
|
(3,453
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
$
|
(622,822
|
)
|
|
$
|
304,743
|
|
|
$
|
47,538
|
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations (1)
|
Total
|
|
Less than
1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than
5 years
|
||||||||||
Term loan - principal
|
$
|
712,852
|
|
|
$
|
36,094
|
|
|
$
|
99,258
|
|
|
$
|
577,500
|
|
|
$
|
—
|
|
Term loan - interest (2)
|
78,274
|
|
|
19,638
|
|
|
35,916
|
|
|
22,720
|
|
|
—
|
|
|||||
2021 Notes - principal
|
575,000
|
|
|
—
|
|
|
—
|
|
|
575,000
|
|
|
—
|
|
|||||
2021 Notes - interest (3)
|
53,906
|
|
|
10,780
|
|
|
21,563
|
|
|
21,563
|
|
|
—
|
|
|||||
Revolving credit facility - principal
|
850,000
|
|
|
—
|
|
|
—
|
|
|
850,000
|
|
|
—
|
|
|||||
Revolving credit facility - interest (2)
|
106,381
|
|
|
24,432
|
|
|
46,446
|
|
|
35,503
|
|
|
—
|
|
|||||
Revolving credit facility - commitment fee (4)
|
6,420
|
|
|
1,418
|
|
|
2,835
|
|
|
2,167
|
|
|
—
|
|
|||||
Commitment to investee (5)
|
20,000
|
|
|
5,000
|
|
|
10,000
|
|
|
5,000
|
|
|
—
|
|
|||||
Purchase obligations (6)
|
28,434
|
|
|
27,074
|
|
|
410
|
|
|
452
|
|
|
498
|
|
|||||
Operating and facility lease obligations (7)
|
125,872
|
|
|
15,442
|
|
|
23,136
|
|
|
19,380
|
|
|
67,914
|
|
|||||
Total
|
$
|
2,557,139
|
|
|
$
|
139,878
|
|
|
$
|
239,564
|
|
|
$
|
2,109,285
|
|
|
$
|
68,412
|
|
(1)
|
This table does not include potential future milestone payment or royalty obligations to third parties under asset purchase, product development, license and other agreements as the timing and likelihood of such milestone payments are not known, and, in the case of royalty obligations, as the amount of such obligations are not estimable. In 2014, we signed a definitive agreement with Aerial under which we acquired worldwide development, manufacturing and commercial rights to JZP-110 (other than in certain jurisdictions in Asia where SK retains rights). Aerial and SK are currently eligible to receive milestone payments up to an aggregate of $270 million based on development, regulatory and sales milestones and tiered royalties from high single digits to mid-teens based on potential future sales of JZP-110. In July 2016, we entered into an agreement with Pfenex under which Pfenex granted us worldwide rights to develop and commercialize multiple early-stage hematology product candidates. The agreement also includes an option for us to negotiate a license for a recombinant pegaspargase product candidate with Pfenex. Under the agreement, Pfenex received upfront, option and development milestone payments totaling $15.8 million and may be eligible to receive additional payments of up to $165 million based on the achievement of development, regulatory and sales milestones. Potential future milestone payments to other third parties under other agreements could be up to an aggregate of $256 million, of which up to $120 million will become due and payable to Perrigo Company plc (formerly Elan Pharmaceuticals, Inc.) in tiered contingent payments, with the first such payment becoming due if net sales of Prialt of at least $75 million are achieved in a calendar year. The remainder would become due and payable to other third parties upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones, the timing and likelihood of which are not known. We are also obligated under these agreements to pay royalties on net sales of certain products at specified rates, which royalties are dependent on future product sales and are not provided for in the table above as they are not estimable.
|
(2)
|
Estimated interest was calculated based on the interest rates in effect as of
December 31, 2016
. The interest rates for our term loan and revolving credit facility borrowings were
2.77%
and
2.69%
, respectively, at
December 31, 2016
.
|
(3)
|
We used the fixed interest rate of
1.875%
to estimate interest owed on the 2021 Notes as of
December 31, 2016
until the final maturity date in August 2021.
|
(4)
|
Our revolving credit facility has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.35% per annum based upon our secured leverage ratio. In the table above, we used a rate of 0.35% and assumed undrawn amounts of
$399.5 million
as of
December 31, 2016
to estimate commitment fees owed. Undrawn borrowing capacity as of
December 31, 2016
does not include an amount of
$0.5 million
committed under an outstanding letter of credit.
|
(5)
|
We committed to invest $25.0 million in Arrivo Bioventures, LLC which can be called on an annual basis over a five-year period. The first capital call of $5.0 million was made during the second quarter of 2016. Our equity method investment is included within other non-current assets on the consolidated balance sheet as of
December 31, 2016
.
|
(6)
|
Consists primarily of non-cancelable commitments to third party manufacturers.
|
(7)
|
Consists primarily of the minimum lease payments for our office buildings and automobile lease payments for our sales force, including a lease agreement we entered into in January 2015 to lease office space located in Palo Alto, California. We expect to occupy this office space by the end of 2017. We are obligated to make lease payments totaling approximately
$88 million
over the initial term of the lease. Not included in the table above are our estimated costs of approximately $20 million associated with the design, development and construction of tenant improvements under this lease agreement, which estimate does not include a tenant improvement allowance to be provided by the landlord. Operating expenses associated with our leased office buildings are also not included in table above.
|
|
Rebates Payable
|
|
Sales Returns Reserve
|
|
Chargebacks
|
|
Discounts and Distributor Fees
|
|
Total
|
||||||||||
Balance at December 31, 2013 (1)
|
$
|
31,558
|
|
|
$
|
21,110
|
|
|
$
|
4,410
|
|
|
$
|
5,890
|
|
|
$
|
62,968
|
|
Provision, net
|
88,729
|
|
|
3,148
|
|
|
28,722
|
|
|
71,864
|
|
|
192,463
|
|
|||||
Payments/credits
|
(75,854
|
)
|
|
(10,219
|
)
|
|
(28,588
|
)
|
|
(71,879
|
)
|
|
(186,540
|
)
|
|||||
Balance at December 31, 2014 (1)
|
44,433
|
|
|
14,039
|
|
|
4,544
|
|
|
5,875
|
|
|
68,891
|
|
|||||
Provision, net
|
124,618
|
|
|
(4,444
|
)
|
|
39,124
|
|
|
46,533
|
|
|
205,831
|
|
|||||
Payments/credits
|
(107,013
|
)
|
|
(3,485
|
)
|
|
(38,772
|
)
|
|
(48,684
|
)
|
|
(197,954
|
)
|
|||||
Balance at December 31, 2015
|
62,038
|
|
|
6,110
|
|
|
4,896
|
|
|
3,724
|
|
|
76,768
|
|
|||||
Provision, net
|
129,608
|
|
|
(537
|
)
|
|
40,430
|
|
|
40,057
|
|
|
209,558
|
|
|||||
Payments/credits
|
(123,383
|
)
|
|
(1,207
|
)
|
|
(40,577
|
)
|
|
(39,582
|
)
|
|
(204,749
|
)
|
|||||
Balance at December 31, 2016
|
$
|
68,263
|
|
|
$
|
4,366
|
|
|
$
|
4,749
|
|
|
$
|
4,199
|
|
|
$
|
81,577
|
|
•
|
estimating the timing of and expected costs to complete the in-process projects;
|
•
|
projecting regulatory approvals;
|
•
|
estimating future cash flows from product sales resulting from completed products and in-process projects; and
|
•
|
developing appropriate discount rates and probability rates by project.
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 8.
|
Financial Statements and Supplementary Data
|
Item 9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
Item 9A.
|
Controls and Procedures
|
1.
|
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
|
2.
|
Our management used the Committee of Sponsoring Organizations of the Treadway Commission Internal Control - Integrated Framework (2013), or the COSO framework, to evaluate the effectiveness of internal control over financial reporting. Management believes that the COSO framework is a suitable framework for its evaluation of financial reporting because it is free from bias, permits reasonably consistent qualitative and quantitative measurements of our internal control over financial reporting, is sufficiently complete so that those relevant factors that would alter a conclusion about the effectiveness of our internal control over financial reporting are not omitted and is relevant to an evaluation of internal control over financial reporting.
|
3.
|
Management has assessed the effectiveness of our internal control over financial reporting as of
December 31, 2016
and has concluded that such internal control over financial reporting was effective. There were no material weaknesses in internal control over financial reporting identified by management.
|
4.
|
KPMG, our independent registered public accounting firm, has audited the consolidated financial statements of Jazz Pharmaceuticals plc as of and for the year ended
December 31, 2016
, included herein, and has issued an audit report on our internal control over financial reporting, which is included below.
|
Item 9B.
|
Other Information
|
Item 10.
|
Directors, Executive Officers and Corporate Governance
|
•
|
The information relating to our directors and nominees for director is to be included in the section entitled “Proposal 1—Election of Directors;”
|
•
|
The information relating to our executive officers is to be included in the section entitled “Executive Officers;”
|
•
|
The information relating to our audit committee, audit committee financial expert and procedures by which shareholders may recommend nominees to our board of directors is to be included in the section entitled “Corporate Governance and Board Matters;” and
|
•
|
The information regarding compliance with Section 16(a) of the Exchange Act is to be included in the section entitled “Section 16(a) Beneficial Ownership Reporting Compliance.”
|
Item 11.
|
Executive Compensation
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence
|
Item 14.
|
Principal Accountant Fees and Services
|
Item 15.
|
Exhibits and Financial Statement Schedules
|
1.
|
Index to Financial Statements:
|
2.
|
Financial Statement Schedules:
|
Exhibit
Number
|
|
Description of Document
|
|
2.1
|
|
Agreement and Plan of Merger and Reorganization, dated as of September 19, 2011, by and among Azur Pharma Limited (now Jazz Pharmaceuticals plc), Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500) filed with the SEC on September 19, 2011).
|
|
2.2
|
|
Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
2.3
|
|
Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on April 27, 2012).
|
|
2.4
|
|
Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 12, 2012).
|
|
2.5
|
|
Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l. and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K/A (File No. 001-33500), as filed with the SEC on December 20, 2013).
|
|
2.6†
|
|
Asset Purchase Agreement, dated January 13, 2014, by and among Jazz Pharmaceuticals International III Limited, Aerial BioPharma, LLC and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 13, 2014).
|
|
2.7†
|
|
Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 5, 2014).
|
|
2.8
|
|
Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on March 23, 2015).
|
|
2.9
|
|
Agreement and Plan of Merger, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc., and Celator Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on May 31, 2016).
|
|
3.1
|
|
Amended and Restated Memorandum and Articles of Association of Jazz Pharmaceuticals plc, as amended on August 4, 2016 (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
4.1
|
|
Reference is made to Exhibit 3.1.
|
|
4.2A
|
|
Investor Rights Agreement, dated July 7, 2009 by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 10.88 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on July 7, 2009).
|
|
4.2B
|
|
Assignment, Assumption and Amendment Agreement, dated as of January 18, 2012, by and among Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and the other parties named therein (incorporated herein by reference to Exhibit 4.7B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
4.2C
|
|
Indenture, dated as of August 13, 2014, by and among Jazz Pharmaceuticals plc, Jazz Investments I Limited and U.S. Bank National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
4.2D
|
|
Form of 1.875% Exchangeable Senior Note due 2021 (incorporated herein by reference to Exhibit 4.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
10.1†
|
|
Supply Agreement, dated as of April 1, 2010, by and between Jazz Pharmaceuticals, Inc. and Siegfried (USA) Inc. (incorporated herein by reference to Exhibit 10.54 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2010, as filed with the SEC on May 6, 2010).
|
|
10.2†
|
|
Master Services Agreement, dated April 15, 2011, by and between Jazz Pharmaceuticals, Inc., CuraScript, Inc. and Express Scripts Specialty Distribution Services, Inc. (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2011, as filed with the SEC on May 9, 2011).
|
|
10.3†
|
|
Royalty Bearing Licence Agreement and Supply Agreement Re Erwinia-Derived Asparaginase, dated July 22, 2005, between Public Health England (formerly Health Protection Agency) and EUSA Pharma SAS (formerly OPi, S.A.), as amended on each of December 22, 2009, March 23, 2012 and August 8, 2012 (incorporated herein by reference to Exhibit 10.11 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q/A (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 9, 2012).
|
|
10.4
|
|
Novation Agreement relating to Royalty Bearing Licence Agreement and Supply Agreement re Erwinia-Derived Asparaginase, dated as of May 13, 2015, by and among EUSA Pharma SAS, the Secretary of State for Health acting through Public Health England and Porton Biopharma Limited (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.5†
|
|
Master Manufacturing Services Agreement, dated as of October 1, 2015, by and between Jazz Pharmaceuticals Ireland Limited and Patheon Pharmaceuticals Inc. (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.6A
|
|
Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc's Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 18, 2015).
|
|
10.6B
|
|
Amendment No. 1, dated as of July 12, 2016, to Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.7A
|
|
Commercial Lease, dated as of June 2, 2004, by and between Jazz Pharmaceuticals, Inc. and The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.52 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on March 27, 2007).
|
|
10.7B
|
|
First Amendment of Lease, dated June 1, 2009, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.86 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 4, 2009).
|
|
10.7C
|
|
Second Amendment of Lease, dated February 28, 2012, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.31 in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
10.8
|
|
Lease, dated May 8, 2012, by and between John Ronan and Castle Cove Property Developments Limited and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.9
|
|
Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.10+
|
|
Form of Indemnification Agreement between Jazz Pharmaceuticals plc and its officers and directors (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
10.11+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Suzanne Sawochka Hooper (incorporated herein by reference to Exhibit 10.19 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012).
|
|
10.12+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Matthew Young (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2014, as filed with the SEC on May 8, 2014).
|
|
10.13A+
|
|
Employment Agreement by and between EUSA Pharma Inc. and Iain McGill (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.13B+
|
|
Amendment to Employment Agreement by and between Iain McGill and EUSA Pharma (Europe) Limited (incorporated herein by reference to Exhibit 10.15B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.13C+
|
|
Amended and Restated Schedule 3 to Employment Agreement by and between Jazz Pharmaceuticals UK Ltd and Iain McGill (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.13D+
|
|
Change in Control Stock Award Acceleration Agreement by and between Jazz Pharmaceuticals plc and Iain McGill (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.14+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Michael Miller (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15A+
|
|
Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15B+
|
|
Amendment to Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.17B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.15C+
|
|
Amended and Restated Schedule 3 to Employment Agreement by and between Jazz Pharmaceuticals Ireland Ltd. and Paul Treacy (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.15D+
|
|
Change in Control Stock Award Acceleration Agreement by and between Jazz Pharmaceuticals plc and Paul Treacy (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.16+
|
|
Amended and Restated Offer Letter, dated as of July 29, 2015, from Jazz Pharmaceuticals, Inc. to Karen Smith, M.D., Ph.D. ((incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2015, as filed with the SEC on November 9, 2015).
|
|
10.17A+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.3 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.17B+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.3B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.17C+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27C in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17D+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (Irish) under Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17E+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27F in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17G+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.17H+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18A+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.18B+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.39B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.18C+
|
|
Form of Option Grant Notice and Form of Stock Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18D+
|
|
Form of Stock Option Grant Notice and Form of Option Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18E+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18G+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18H+
|
|
Form of Non-U.S. Restricted Stock Unit Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28H in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18I+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Option Grant Notice and Form of U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18J+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18K+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18L+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18M+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2016, as filed with the SEC on May 10, 2016).
|
|
10.18N+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2016, as filed with the SEC on May 10, 2016).
|
|
10.18O+
|
|
Amended and Restated 2011 Equity Incentive Plan (approved August 4, 2016) (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.18P+
|
|
Amended and Restated 2011 Equity Incentive Plan (approved November 3, 2016) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.18Q+
|
|
Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.18R+
|
|
Form of U.S. Option Grant Notice and Form of U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.18S+
|
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.19+
|
|
Jazz Pharmaceuticals plc Amended and Restated Directors Deferred Compensation Plan (incorporated herein by reference to Exhibit 99.6 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20A+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 99.4 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20B+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 10.30B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.20C+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved August 1, 2013) (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.20D+
|
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan (approved August 4, 2016) (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.20E+
|
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan (approved November 3, 2016) (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.20F+
|
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.20G+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated Non-Employee Directors 2007 Stock Award Plan (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.21A+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan, as amended and restated (incorporated herein by reference to Exhibit 10.31A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.21B+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan Sub-Plan Governing Purchase Rights to Participants in the Republic of Ireland (incorporated by reference herein to Exhibit 10.14C in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012 ).
|
|
10.22A+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (approved November 4, 2015) (incorporated herein by reference to Exhibit 10.22B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.22B+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (approved November 3, 2016).
|
|
10.22C+
|
|
Jazz Pharmaceuticals Cash Bonus Plan for International Affiliates (2014) (incorporated herein by reference to Exhibit 10.24D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2013, as filed with the SEC on February 25, 2014).
|
|
10.22D+
|
|
Jazz Pharmaceuticals Cash Bonus Plan (Ireland and Other Specified Affiliates) (Calendar Year 2016) (incorporated herein by reference to Exhibit 10.22D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.22E+
|
|
Jazz Pharmaceuticals Cash Bonus Plan (Ireland and Other Specified Affiliates) (Calendar Year 2017).
|
|
10.23+
|
|
Jazz Pharmaceuticals plc Amended and Restated Executive Change in Control and Severance Benefit Plan (approved February 10, 2016) (incorporated herein by reference to Exhibit 10.23 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.24+
|
|
Jazz Pharmaceuticals plc 2015 Executive Officer Compensation Arrangements (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2015, as filed with the SEC on May 7, 2015).
|
|
10.25A+
|
|
Jazz Pharmaceuticals plc Non-Employee Director Compensation Policy (approved April 30, 2015) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.25B+
|
|
Amended and Restated Non-Employee Director Compensation Policy (approved May 5, 2016) (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.27
|
|
Tender and Support Agreement, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc. and each of the persons set forth on Schedule A attached thereto (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on May 31, 2016).
|
|
21.1
|
|
Subsidiaries of Jazz Pharmaceuticals plc.
|
|
23.1
|
|
Consent of KPMG, Independent Registered Public Accounting Firm.
|
|
24.1
|
|
Power of Attorney (included on the signature page hereto).
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
32.1*
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
+
|
Indicates management contract or compensatory plan.
|
†
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
*
|
The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
Item 16.
|
Form 10-K Summary
|
Date: February 28, 2017
|
Jazz Pharmaceuticals public limited company
|
|
(Registrant)
|
|
/s/ B
RUCE
C. C
OZADD
|
|
Bruce C. Cozadd
Chairman and Chief Executive Officer and Director
(Principal Executive Officer)
|
|
|
|
/s/ M
ATTHEW
P. Y
OUNG
|
|
Matthew P. Young
Executive Vice President and Chief Financial Officer (Principal Financial Officer)
|
|
|
|
/s/ K
AREN
J. W
ILSON
|
|
Karen J. Wilson
Senior Vice President, Finance
(Principal Accounting Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ B
RUCE
C. C
OZADD
|
|
Chairman, Chief Executive Officer and Director
(Principal Executive Officer)
|
|
February 28, 2017
|
Bruce C. Cozadd
|
|
|
||
/s/ M
ATTHEW
P. Y
OUNG
|
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|
|
February 28, 2017
|
Matthew P. Young
|
|
|
||
/s/ K
AREN
J. W
ILSON
|
|
Senior Vice President, Finance
(Principal Accounting Officer)
|
|
February 28, 2017
|
Karen J. Wilson
|
|
|
||
/s/ P
AUL
L. B
ERNS
|
|
Director
|
|
February 28, 2017
|
Paul L. Berns
|
|
|
||
/s/ P
ATRICK
G. E
NRIGHT
|
|
Director
|
|
February 28, 2017
|
Patrick G. Enright
|
|
|
||
/s/ P
ETER
G
RAY
|
|
Director
|
|
February 28, 2017
|
Peter Gray
|
|
|
||
/s/ H
EATHER
A
NN
M
CSHARRY
|
|
Director
|
|
February 28, 2017
|
Heather Ann McSharry
|
|
|
||
/s/ S
EAMUS
C. M
ULLIGAN
|
|
Director
|
|
February 28, 2017
|
Seamus C. Mulligan
|
|
|
||
/s/ K
ENNETH
W. O’
KEEFE
|
|
Director
|
|
February 28, 2017
|
Kenneth W. O’Keefe
|
|
|
||
/s/
N
ORBERT
G
.
R
IEDEL,
P
H.
D
.
|
|
Director
|
|
February 28, 2017
|
Norbert G. Riedel, Ph.D.
|
|
|
||
/s/ E
LMAR
S
CHNEE
|
|
Director
|
|
February 28, 2017
|
Elmar Schnee
|
|
|
||
/s/ C
ATHERINE
A. S
OHN,
P
HARM
.D.
|
|
Director
|
|
February 28, 2017
|
Catherine A. Sohn, Pharm.D.
|
|
|
||
/s/ R
ICK
E W
INNINGHAM
|
|
Director
|
|
February 28, 2017
|
Rick E Winningham
|
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
365,963
|
|
|
$
|
988,785
|
|
Investments
|
60,000
|
|
|
—
|
|
||
Accounts receivable, net of allowances of $5,154 and $3,693 at December 31, 2016 and 2015, respectively
|
234,244
|
|
|
209,685
|
|
||
Inventories
|
34,051
|
|
|
19,451
|
|
||
Prepaid expenses
|
24,501
|
|
|
20,699
|
|
||
Other current assets
|
29,310
|
|
|
19,047
|
|
||
Total current assets
|
748,069
|
|
|
1,257,667
|
|
||
Property and equipment, net
|
107,490
|
|
|
85,572
|
|
||
Intangible assets, net
|
3,012,001
|
|
|
1,185,606
|
|
||
Goodwill
|
893,810
|
|
|
657,139
|
|
||
Deferred tax assets, net, non-current
|
15,060
|
|
|
130,148
|
|
||
Deferred financing costs
|
9,737
|
|
|
7,209
|
|
||
Other non-current assets
|
14,060
|
|
|
9,271
|
|
||
Total assets
|
$
|
4,800,227
|
|
|
$
|
3,332,612
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
22,415
|
|
|
$
|
21,807
|
|
Accrued liabilities
|
193,268
|
|
|
164,070
|
|
||
Current portion of long-term debt
|
36,094
|
|
|
37,587
|
|
||
Income taxes payable
|
4,506
|
|
|
1,808
|
|
||
Deferred revenue
|
1,123
|
|
|
1,370
|
|
||
Total current liabilities
|
257,406
|
|
|
226,642
|
|
||
Deferred revenue, non-current
|
2,601
|
|
|
3,721
|
|
||
Long-term debt, less current portion
|
1,993,531
|
|
|
1,150,857
|
|
||
Deferred tax liability, net, non-current
|
556,733
|
|
|
283,493
|
|
||
Other non-current liabilities
|
112,617
|
|
|
69,253
|
|
||
Commitments and contingencies (Note 11)
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
||||
Ordinary shares, nominal value $0.0001 per share; 300,000 shares authorized; 59,820 and 61,305 shares issued and outstanding at December 31, 2016 and 2015, respectively
|
6
|
|
|
6
|
|
||
Non-voting euro deferred shares, €0.01 par value per share; 4,000 shares authorized, issued and outstanding at both December 31, 2016 and 2015
|
55
|
|
|
55
|
|
||
Capital redemption reserve
|
472
|
|
|
471
|
|
||
Additional paid-in capital
|
1,665,232
|
|
|
1,562,900
|
|
||
Accumulated other comprehensive loss
|
(317,333
|
)
|
|
(267,472
|
)
|
||
Retained earnings
|
528,907
|
|
|
302,686
|
|
||
Total shareholders’ equity
|
1,877,339
|
|
|
1,598,646
|
|
||
Total liabilities and shareholders’ equity
|
$
|
4,800,227
|
|
|
$
|
3,332,612
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
1,477,261
|
|
|
$
|
1,316,819
|
|
|
$
|
1,162,716
|
|
Royalties and contract revenues
|
10,712
|
|
|
7,984
|
|
|
10,159
|
|
|||
Total revenues
|
1,487,973
|
|
|
1,324,803
|
|
|
1,172,875
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of product sales (excluding amortization and impairment of intangible assets)
|
105,386
|
|
|
102,526
|
|
|
117,418
|
|
|||
Selling, general and administrative
|
502,892
|
|
|
449,119
|
|
|
406,114
|
|
|||
Research and development
|
162,297
|
|
|
135,253
|
|
|
85,181
|
|
|||
Acquired in-process research and development
|
23,750
|
|
|
—
|
|
|
202,626
|
|
|||
Intangible asset amortization
|
101,994
|
|
|
98,162
|
|
|
126,584
|
|
|||
Impairment charges
|
—
|
|
|
31,523
|
|
|
39,365
|
|
|||
Total operating expenses
|
896,319
|
|
|
816,583
|
|
|
977,288
|
|
|||
Income from operations
|
591,654
|
|
|
508,220
|
|
|
195,587
|
|
|||
Interest expense, net
|
(61,942
|
)
|
|
(56,917
|
)
|
|
(52,713
|
)
|
|||
Foreign currency gain
|
3,372
|
|
|
1,445
|
|
|
8,683
|
|
|||
Loss on extinguishment and modification of debt
|
(638
|
)
|
|
(16,815
|
)
|
|
—
|
|
|||
Income before income tax provision and equity in loss of investee
|
532,446
|
|
|
435,933
|
|
|
151,557
|
|
|||
Income tax provision
|
135,236
|
|
|
106,399
|
|
|
94,231
|
|
|||
Equity in loss of investee
|
379
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
396,831
|
|
|
329,534
|
|
|
57,326
|
|
|||
Net loss attributable to noncontrolling interests
|
—
|
|
|
(1
|
)
|
|
(1,061
|
)
|
|||
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
396,831
|
|
|
$
|
329,535
|
|
|
$
|
58,387
|
|
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share:
|
|
|
|
|
|
||||||
Basic
|
$
|
6.56
|
|
|
$
|
5.38
|
|
|
$
|
0.98
|
|
Diluted
|
$
|
6.41
|
|
|
$
|
5.23
|
|
|
$
|
0.93
|
|
Weighted-average ordinary shares used in per share calculations - basic
|
60,500
|
|
|
61,232
|
|
|
59,746
|
|
|||
Weighted-average ordinary shares used in per share calculations - diluted
|
61,870
|
|
|
63,036
|
|
|
62,614
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net income
|
$
|
396,831
|
|
|
$
|
329,534
|
|
|
$
|
57,326
|
|
Other comprehensive loss:
|
|
|
|
|
|
||||||
Foreign currency translation adjustments
|
(49,861
|
)
|
|
(145,375
|
)
|
|
(178,264
|
)
|
|||
Other comprehensive loss
|
(49,861
|
)
|
|
(145,375
|
)
|
|
(178,264
|
)
|
|||
Total comprehensive income (loss)
|
346,970
|
|
|
184,159
|
|
|
(120,938
|
)
|
|||
Comprehensive loss attributable to noncontrolling interests
|
—
|
|
|
(1
|
)
|
|
(1,075
|
)
|
|||
Comprehensive income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
346,970
|
|
|
$
|
184,160
|
|
|
$
|
(119,863
|
)
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income (Loss)
|
|
Retained Earnings
|
|
Total Jazz Pharma-ceuticals plc
Share-holders’
Equity
|
|
Non-control-ling interest
|
|
Total
Equity
|
||||||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||||||||||
Balance at December 31, 2013
|
57,854
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,220,317
|
|
|
$
|
56,153
|
|
|
$
|
18,532
|
|
|
$
|
1,295,534
|
|
|
$
|
—
|
|
|
$
|
1,295,534
|
|
Noncontrolling interest on Gentium Acquisition
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
136,578
|
|
|
136,578
|
|
|||||||||
Acquisition of noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,530
|
)
|
|
—
|
|
|
—
|
|
|
(1,530
|
)
|
|
(135,439
|
)
|
|
(136,969
|
)
|
|||||||||
Issuance of exchangeable senior notes
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
126,863
|
|
|
—
|
|
|
—
|
|
|
126,863
|
|
|
—
|
|
|
126,863
|
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of share options
|
1,185
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
43,043
|
|
|
—
|
|
|
—
|
|
|
43,043
|
|
|
—
|
|
|
43,043
|
|
|||||||||
Issuance of ordinary shares under employee stock purchase plan
|
117
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,197
|
|
|
—
|
|
|
—
|
|
|
7,197
|
|
|
—
|
|
|
7,197
|
|
|||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units
|
222
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(18,030
|
)
|
|
—
|
|
|
—
|
|
|
(18,030
|
)
|
|
—
|
|
|
(18,030
|
)
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of warrants
|
1,552
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,247
|
|
|
—
|
|
|
—
|
|
|
8,247
|
|
|
—
|
|
|
8,247
|
|
|||||||||
Shares issued under directors deferred compensation plan
|
17
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
70,057
|
|
|
—
|
|
|
—
|
|
|
70,057
|
|
|
—
|
|
|
70,057
|
|
|||||||||
Excess tax benefits from employee share options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,841
|
|
|
—
|
|
|
—
|
|
|
1,841
|
|
|
—
|
|
|
1,841
|
|
|||||||||
Shares repurchased
|
(304
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(42,215
|
)
|
|
(42,215
|
)
|
|
—
|
|
|
(42,215
|
)
|
|||||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(178,250
|
)
|
|
—
|
|
|
(178,250
|
)
|
|
(14
|
)
|
|
(178,264
|
)
|
|||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
58,387
|
|
|
58,387
|
|
|
(1,061
|
)
|
|
57,326
|
|
|||||||||
Balance at December 31, 2014
|
60,643
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,458,005
|
|
|
$
|
(122,097
|
)
|
|
$
|
34,704
|
|
|
$
|
1,371,144
|
|
|
$
|
64
|
|
|
$
|
1,371,208
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income (Loss)
|
|
Retained Earnings
|
|
Total Jazz Pharma-ceuticals plc
Share-holders’
Equity
|
|
Non-control-ling interest
|
|
Total
Equity
|
||||||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||||||||||
Balance at December 31, 2014
|
60,643
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,458,005
|
|
|
$
|
(122,097
|
)
|
|
$
|
34,704
|
|
|
$
|
1,371,144
|
|
|
$
|
64
|
|
|
$
|
1,371,208
|
|
Acquisition of noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
(63
|
)
|
|
(73
|
)
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of share options
|
732
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32,982
|
|
|
—
|
|
|
—
|
|
|
32,982
|
|
|
—
|
|
|
32,982
|
|
|||||||||
Issuance of ordinary shares under employee stock purchase plan
|
75
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,541
|
|
|
—
|
|
|
—
|
|
|
7,541
|
|
|
—
|
|
|
7,541
|
|
|||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units
|
265
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(26,102
|
)
|
|
—
|
|
|
—
|
|
|
(26,102
|
)
|
|
—
|
|
|
(26,102
|
)
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
91,795
|
|
|
—
|
|
|
—
|
|
|
91,795
|
|
|
—
|
|
|
91,795
|
|
|||||||||
Excess tax benefits from employee share options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,311
|
)
|
|
—
|
|
|
—
|
|
|
(1,311
|
)
|
|
—
|
|
|
(1,311
|
)
|
|||||||||
Shares repurchased
|
(410
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(61,553
|
)
|
|
(61,553
|
)
|
|
—
|
|
|
(61,553
|
)
|
|||||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(145,375
|
)
|
|
—
|
|
|
(145,375
|
)
|
|
—
|
|
|
(145,375
|
)
|
|||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
329,535
|
|
|
329,535
|
|
|
(1
|
)
|
|
329,534
|
|
|||||||||
Balance at December 31, 2015
|
61,305
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,562,900
|
|
|
$
|
(267,472
|
)
|
|
$
|
302,686
|
|
|
$
|
1,598,646
|
|
|
$
|
—
|
|
|
$
|
1,598,646
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income (Loss)
|
|
Retained Earnings
|
|
Total
Equity
|
||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||
Balance at December 31, 2015
|
61,305
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,562,900
|
|
|
$
|
(267,472
|
)
|
|
$
|
302,686
|
|
|
$
|
1,598,646
|
|
Cumulative effect adjustment from adoption of ASU No. 2016-09 (Note 2)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
107,687
|
|
|
107,687
|
|
|||||||
Issuance of ordinary shares in conjunction with exercise of share options
|
399
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16,880
|
|
|
—
|
|
|
—
|
|
|
16,880
|
|
|||||||
Issuance of ordinary shares under employee stock purchase plan
|
70
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,294
|
|
|
—
|
|
|
—
|
|
|
7,294
|
|
|||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units
|
289
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(21,234
|
)
|
|
—
|
|
|
—
|
|
|
(21,234
|
)
|
|||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
99,392
|
|
|
—
|
|
|
—
|
|
|
99,392
|
|
|||||||
Shares repurchased
|
(2,243
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
(278,297
|
)
|
|
(278,296
|
)
|
|||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(49,861
|
)
|
|
—
|
|
|
(49,861
|
)
|
|||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
396,831
|
|
|
396,831
|
|
|||||||
Balance at December 31, 2016
|
59,820
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
472
|
|
|
$
|
1,665,232
|
|
|
$
|
(317,333
|
)
|
|
$
|
528,907
|
|
|
$
|
1,877,339
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net income
|
$
|
396,831
|
|
|
$
|
329,534
|
|
|
$
|
57,326
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Intangible asset amortization
|
101,994
|
|
|
98,162
|
|
|
126,584
|
|
|||
Share-based compensation
|
98,771
|
|
|
91,550
|
|
|
69,638
|
|
|||
Impairment charges
|
—
|
|
|
31,523
|
|
|
39,365
|
|
|||
Depreciation
|
11,786
|
|
|
9,894
|
|
|
7,097
|
|
|||
Acquired in-process research and development
|
23,750
|
|
|
—
|
|
|
202,626
|
|
|||
Loss on disposal of property and equipment
|
47
|
|
|
172
|
|
|
24
|
|
|||
Acquisition accounting inventory fair value step-up adjustments
|
—
|
|
|
—
|
|
|
10,477
|
|
|||
Deferred income taxes
|
(41,163
|
)
|
|
(68,358
|
)
|
|
(49,254
|
)
|
|||
Provision for losses on accounts receivable and inventory
|
2,209
|
|
|
4,062
|
|
|
2,493
|
|
|||
Loss on extinguishment and modification of debt
|
638
|
|
|
16,815
|
|
|
—
|
|
|||
Amortization of debt discount and deferred financing costs
|
22,133
|
|
|
22,738
|
|
|
13,725
|
|
|||
Other non-cash transactions
|
(3,741
|
)
|
|
(5,187
|
)
|
|
(11,986
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(25,603
|
)
|
|
(24,841
|
)
|
|
(55,041
|
)
|
|||
Inventories
|
(17,024
|
)
|
|
6,271
|
|
|
(7,630
|
)
|
|||
Prepaid expenses and other current assets
|
(15,700
|
)
|
|
3,720
|
|
|
11,936
|
|
|||
Other long-term assets
|
267
|
|
|
(4,573
|
)
|
|
(3,060
|
)
|
|||
Accounts payable
|
361
|
|
|
(2,280
|
)
|
|
(37,966
|
)
|
|||
Accrued liabilities
|
10,134
|
|
|
2,986
|
|
|
20,997
|
|
|||
Income taxes payable
|
2,962
|
|
|
(6,271
|
)
|
|
8,634
|
|
|||
Deferred revenue
|
(1,315
|
)
|
|
(536
|
)
|
|
(1,203
|
)
|
|||
Contingent consideration
|
—
|
|
|
—
|
|
|
(14,900
|
)
|
|||
Other non-current liabilities
|
23,199
|
|
|
26,562
|
|
|
17,724
|
|
|||
Net cash provided by operating activities
|
590,536
|
|
|
531,943
|
|
|
407,606
|
|
|||
Investing activities
|
|
|
|
|
|
||||||
Acquisitions, net of cash acquired
|
(1,502,443
|
)
|
|
—
|
|
|
(828,676
|
)
|
|||
Acquisition of intangible assets
|
(150,000
|
)
|
|
—
|
|
|
—
|
|
|||
Acquisition of investments
|
(65,275
|
)
|
|
—
|
|
|
—
|
|
|||
Acquisition of in-process research and development
|
(23,750
|
)
|
|
—
|
|
|
(202,626
|
)
|
|||
Purchases of property and equipment
|
(7,832
|
)
|
|
(35,958
|
)
|
|
(36,347
|
)
|
|||
Net proceeds from sale of business
|
—
|
|
|
33,703
|
|
|
—
|
|
|||
Net cash used in investing activities
|
(1,749,300
|
)
|
|
(2,255
|
)
|
|
(1,067,649
|
)
|
|||
Financing activities
|
|
|
|
|
|
||||||
Net proceeds from issuance of debt
|
994,647
|
|
|
898,642
|
|
|
1,194,385
|
|
|||
Proceeds from employee equity incentive and purchase plans and exercise of warrants
|
24,174
|
|
|
40,523
|
|
|
58,487
|
|
|||
Share repurchases
|
(278,296
|
)
|
|
(61,553
|
)
|
|
(42,215
|
)
|
|||
Acquisition of noncontrolling interests
|
—
|
|
|
(73
|
)
|
|
(136,969
|
)
|
|||
Payment of contingent consideration
|
—
|
|
|
—
|
|
|
(35,100
|
)
|
|||
Payment of employee withholding taxes related to share-based awards
|
(21,234
|
)
|
|
(26,102
|
)
|
|
(18,030
|
)
|
|||
Repayments of long-term debt
|
(28,304
|
)
|
|
(905,760
|
)
|
|
(9,524
|
)
|
|||
Repayments under revolving credit facility
|
(150,000
|
)
|
|
(160,000
|
)
|
|
(300,000
|
)
|
|||
Net cash provided by (used in) financing activities
|
540,987
|
|
|
(214,323
|
)
|
|
711,034
|
|
|||
Effect of exchange rates on cash and cash equivalents
|
(5,045
|
)
|
|
(10,622
|
)
|
|
(3,453
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
(622,822
|
)
|
|
304,743
|
|
|
47,538
|
|
|||
Cash and cash equivalents, at beginning of period
|
988,785
|
|
|
684,042
|
|
|
636,504
|
|
|||
Cash and cash equivalents, at end of period
|
$
|
365,963
|
|
|
$
|
988,785
|
|
|
$
|
684,042
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
39,898
|
|
|
$
|
40,099
|
|
|
$
|
31,978
|
|
Cash paid for income taxes
|
160,306
|
|
|
145,597
|
|
|
108,189
|
|
|||
Non-cash investing activities:
|
|
|
|
|
|
||||||
Construction-in-progress related to facility lease obligation
|
23,799
|
|
|
4,351
|
|
|
—
|
|
•
|
Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, and currently marketed for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
|
•
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
|
•
|
Defitelio
®
(defibrotide sodium)
, a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, or SOS, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio
®
(defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy.
|
•
|
Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;
|
•
|
Acquiring or licensing rights to clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
|
•
|
Pursuing targeted development of post-discovery differentiated product candidates.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
the challenges of achieving and maintaining commercial success of our products;
|
•
|
delays or problems in the supply or manufacture of our products and product candidates, particularly with respect to certain products as to which we maintain limited inventories, our dependence on single source suppliers for most of our products, product candidates and APIs, and the requirement that we and our product suppliers be qualified by the FDA to manufacture product and comply with applicable manufacturing regulations;
|
•
|
the need to obtain and maintain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to healthcare cost containment and
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business;
|
•
|
the challenges of compliance with the requirements of the FDA, the DEA, and comparable non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, patient assistance programs, adverse event reporting and product recalls or withdrawals;
|
•
|
the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates;
|
•
|
the inherent uncertainty associated with the regulatory approval process, especially as we continue to increase investment in our product pipeline development projects and undertake multiple planned NDA submissions for our product candidates;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, including risks associated with the Celator Acquisition, such as the challenges inherent in the integration of acquired businesses with our historical business, the increase in geographic dispersion among our centers of operation and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such transactions; and
|
•
|
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations, as a result of, among other things, the Celator Acquisition.
|
Buildings
|
40 years
|
Manufacturing equipment and machinery
|
5-10 years
|
Computer software and equipment
|
3 years
|
Furniture and fixtures
|
5 years
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
396,831
|
|
|
$
|
329,535
|
|
|
$
|
58,387
|
|
Denominator:
|
|
|
|
|
|
||||||
Weighted-average ordinary shares used in per share calculation - basic
|
60,500
|
|
|
61,232
|
|
|
59,746
|
|
|||
Dilutive effect of employee equity incentive and purchase plans
|
1,370
|
|
|
1,804
|
|
|
2,402
|
|
|||
Dilutive effect of warrants
|
—
|
|
|
—
|
|
|
466
|
|
|||
Weighted-average ordinary shares used in per share calculation - diluted
|
61,870
|
|
|
63,036
|
|
|
62,614
|
|
|||
|
|
|
|
|
|
||||||
Net income per ordinary share :
|
|
|
|
|
|
||||||
Basic
|
$
|
6.56
|
|
|
$
|
5.38
|
|
|
$
|
0.98
|
|
Diluted
|
$
|
6.41
|
|
|
$
|
5.23
|
|
|
$
|
0.93
|
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
1.875% exchangeable senior notes due 2021
|
2,878
|
|
|
2,878
|
|
|
1,112
|
|
Options to purchase ordinary shares and RSUs
|
3,010
|
|
|
1,609
|
|
|
819
|
|
Ordinary shares under ESPP
|
93
|
|
|
—
|
|
|
—
|
|
Cash and cash equivalents
|
$
|
26,137
|
|
Other receivables
|
386
|
|
|
Prepaid expenses and deposits
|
151
|
|
|
Property and equipment
|
767
|
|
|
Intangible assets
|
1,811,250
|
|
|
Goodwill
|
252,825
|
|
|
Other non-current assets
|
43
|
|
|
Accrued liabilities
|
(19,076
|
)
|
|
Deferred tax liability, net, non-current
|
(542,901
|
)
|
|
Other non-current liabilities
|
(1,002
|
)
|
|
Total acquisition consideration - cash paid
|
$
|
1,528,580
|
|
•
|
The exclusion of acquisition-related and integration expenses of
$13.6 million
in 2016 and the inclusion of these expenses in 2015.
|
•
|
An increase in interest expense of
$13.7 million
in 2016 and
$25.9 million
in 2015 incurred on additional borrowings made to partially fund the Celator Acquisition as if the borrowings had occurred on January 1, 2015.
|
|
Year Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Revenues
|
$
|
1,488,118
|
|
|
$
|
1,326,246
|
|
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
386,342
|
|
|
$
|
283,113
|
|
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - basic
|
$
|
6.39
|
|
|
$
|
4.62
|
|
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - diluted
|
$
|
6.24
|
|
|
$
|
4.49
|
|
|
December 31, 2016
|
||||||||||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Cash and Cash Equivalents
|
|
Investments
|
||||||||||||
Cash
|
$
|
215,963
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
215,963
|
|
|
$
|
215,963
|
|
|
$
|
—
|
|
Time deposits
|
210,000
|
|
|
—
|
|
|
—
|
|
|
210,000
|
|
|
150,000
|
|
|
60,000
|
|
||||||
Totals
|
$
|
425,963
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
425,963
|
|
|
$
|
365,963
|
|
|
$
|
60,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
December 31, 2015
|
||||||||||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Cash and
Cash Equivalents |
|
Investments
|
||||||||||||
Cash
|
$
|
274,945
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
274,945
|
|
|
$
|
274,945
|
|
|
$
|
—
|
|
Time deposits
|
713,840
|
|
|
—
|
|
|
—
|
|
|
713,840
|
|
|
713,840
|
|
|
—
|
|
||||||
Totals
|
$
|
988,785
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
988,785
|
|
|
$
|
988,785
|
|
|
$
|
—
|
|
|
December 31, 2016
|
|
December 31, 2015
|
||||||||||||
|
Significant
Other Observable Inputs (Level 2) |
|
Total
Estimated Fair Value |
|
Significant
Other Observable Inputs (Level 2) |
|
Total
Estimated Fair Value |
||||||||
Time deposits
|
$
|
210,000
|
|
|
$
|
210,000
|
|
|
$
|
713,840
|
|
|
$
|
713,840
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Land and buildings
|
$
|
46,033
|
|
|
$
|
1,775
|
|
Construction-in-progress
|
33,427
|
|
|
63,008
|
|
||
Manufacturing equipment and machinery
|
19,596
|
|
|
5,828
|
|
||
Computer software
|
17,832
|
|
|
15,797
|
|
||
Computer equipment
|
10,980
|
|
|
10,963
|
|
||
Leasehold improvements
|
9,328
|
|
|
9,301
|
|
||
Furniture and fixtures
|
2,436
|
|
|
2,580
|
|
||
Subtotal
|
139,632
|
|
|
109,252
|
|
||
Less accumulated depreciation and amortization
|
(32,142
|
)
|
|
(23,680
|
)
|
||
Property and equipment, net
|
$
|
107,490
|
|
|
$
|
85,572
|
|
Balance at December 31, 2015
|
$
|
657,139
|
|
Goodwill arising from the Celator Acquisition
|
252,825
|
|
|
Foreign exchange
|
(16,154
|
)
|
|
Balance at December 31, 2016
|
$
|
893,810
|
|
|
December 31, 2016
|
|
December 31, 2015
|
||||||||||||||||||||||
|
Remaining
Weighted- Average Useful Life (In years) |
|
Gross
Carrying Amount |
|
Accumulated
Amortization |
|
Net Book
Value |
|
Gross
Carrying Amount |
|
Accumulated
Amortization |
|
Net Book
Value |
||||||||||||
Acquired developed technologies
|
11.3
|
|
$
|
1,477,618
|
|
|
$
|
(410,523
|
)
|
|
$
|
1,067,095
|
|
|
$
|
1,321,324
|
|
|
$
|
(324,044
|
)
|
|
$
|
997,280
|
|
Manufacturing contracts
|
1.1
|
|
11,278
|
|
|
(8,292
|
)
|
|
2,986
|
|
|
11,697
|
|
|
(5,676
|
)
|
|
6,021
|
|
||||||
Trademarks
|
—
|
|
2,872
|
|
|
(2,872
|
)
|
|
—
|
|
|
2,882
|
|
|
(2,882
|
)
|
|
—
|
|
||||||
Total finite-lived intangible assets
|
|
|
1,491,768
|
|
|
(421,687
|
)
|
|
1,070,081
|
|
|
1,335,903
|
|
|
(332,602
|
)
|
|
1,003,301
|
|
||||||
Acquired IPR&D assets
|
|
|
1,941,920
|
|
|
—
|
|
|
1,941,920
|
|
|
182,305
|
|
|
—
|
|
|
182,305
|
|
||||||
Total intangible assets
|
|
|
$
|
3,433,688
|
|
|
$
|
(421,687
|
)
|
|
$
|
3,012,001
|
|
|
$
|
1,518,208
|
|
|
$
|
(332,602
|
)
|
|
$
|
1,185,606
|
|
Year Ending December 31,
|
Estimated Amortization Expense
|
||
2017
|
$
|
102,084
|
|
2018
|
99,379
|
|
|
2019
|
99,169
|
|
|
2020
|
98,041
|
|
|
2021
|
97,118
|
|
|
Thereafter
|
574,290
|
|
|
Total
|
$
|
1,070,081
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Rebates and other sales deductions
|
$
|
72,344
|
|
|
$
|
67,454
|
|
Employee compensation and benefits
|
43,363
|
|
|
35,595
|
|
||
Royalties
|
11,643
|
|
|
4,211
|
|
||
Accrued contract termination fees
|
11,612
|
|
|
—
|
|
||
Clinical trial accruals
|
10,139
|
|
|
1,601
|
|
||
Accrued interest
|
5,179
|
|
|
4,043
|
|
||
Professional fees
|
4,596
|
|
|
3,038
|
|
||
Sales returns reserve
|
4,366
|
|
|
6,110
|
|
||
Inventory-related accruals
|
3,350
|
|
|
1,017
|
|
||
Accrued construction-in-progress
|
1,597
|
|
|
1,637
|
|
||
Contract claim settlement
|
—
|
|
|
18,000
|
|
||
Other
|
25,079
|
|
|
21,364
|
|
||
Total accrued liabilities
|
$
|
193,268
|
|
|
$
|
164,070
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
1.875% exchangeable senior notes due 2021
|
$
|
575,000
|
|
|
$
|
575,000
|
|
Unamortized discount on 1.875% exchangeable senior notes due 2021
|
(101,094
|
)
|
|
(119,467
|
)
|
||
1.875% exchangeable senior notes due 2021, net
|
473,906
|
|
|
455,533
|
|
||
Borrowings under revolving credit facility
|
850,000
|
|
|
—
|
|
||
Term loan
|
705,719
|
|
|
732,398
|
|
||
Other borrowings
|
—
|
|
|
513
|
|
||
Total debt
|
2,029,625
|
|
|
1,188,444
|
|
||
Less current portion
|
36,094
|
|
|
37,587
|
|
||
Total long-term debt
|
$
|
1,993,531
|
|
|
$
|
1,150,857
|
|
Year Ending December 31,
|
Scheduled Long-Term Debt Maturities
|
||
2017
|
$
|
36,094
|
|
2018
|
40,606
|
|
|
2019
|
58,652
|
|
|
2020
|
76,699
|
|
|
2021
|
1,925,801
|
|
|
Total
|
$
|
2,137,852
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Lease expense
|
$
|
11,600
|
|
|
$
|
10,479
|
|
|
$
|
10,678
|
|
Year ending December 31,
|
Lease
Payments
|
||
2017
|
$
|
15,442
|
|
2018
|
12,255
|
|
|
2019
|
10,881
|
|
|
2020
|
9,941
|
|
|
2021
|
9,439
|
|
|
Thereafter
|
67,914
|
|
|
Total
|
$
|
125,872
|
|
|
December 31, 2016
|
|
2011 Equity Incentive Plan
|
13,988
|
|
2007 Equity Incentive Plan
|
918
|
|
2007 Employee Stock Purchase Plan
|
443
|
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan
|
485
|
|
Amended and Restated Directors Deferred Compensation Plan
|
178
|
|
Total
|
16,012
|
|
|
Foreign
Currency Translation Adjustments |
|
Total
Accumulated Other Comprehensive Loss |
||||
Balance at December 31, 2015
|
$
|
(267,472
|
)
|
|
$
|
(267,472
|
)
|
Other comprehensive loss
|
(49,861
|
)
|
|
(49,861
|
)
|
||
Balance at December 31, 2016
|
$
|
(317,333
|
)
|
|
$
|
(317,333
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Xyrem
|
$
|
1,107,616
|
|
|
$
|
955,187
|
|
|
$
|
778,584
|
|
Erwinaze/Erwinase
|
200,678
|
|
|
203,261
|
|
|
199,665
|
|
|||
Defitelio/defibrotide
|
108,952
|
|
|
70,731
|
|
|
70,537
|
|
|||
Prialt
®
(ziconotide) intrathecal infusion
|
29,120
|
|
|
26,440
|
|
|
26,421
|
|
|||
Psychiatry
|
17,653
|
|
|
37,135
|
|
|
40,879
|
|
|||
Other
|
13,242
|
|
|
24,065
|
|
|
46,630
|
|
|||
Product sales, net
|
1,477,261
|
|
|
1,316,819
|
|
|
1,162,716
|
|
|||
Royalties and contract revenues
|
10,712
|
|
|
7,984
|
|
|
10,159
|
|
|||
Total revenues
|
$
|
1,487,973
|
|
|
$
|
1,324,803
|
|
|
$
|
1,172,875
|
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Express Scripts
|
74
|
%
|
|
72
|
%
|
|
66
|
%
|
McKesson Corporation and affiliates
|
15
|
%
|
|
7
|
%
|
|
—
|
%
|
Accredo Health Group, Inc.
|
—
|
%
|
|
6
|
%
|
|
14
|
%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Ireland
|
$
|
62,453
|
|
|
$
|
62,795
|
|
United States
|
35,791
|
|
|
12,794
|
|
||
Italy
|
7,000
|
|
|
7,928
|
|
||
Other
|
2,246
|
|
|
2,055
|
|
||
Total long-lived assets
(1)
|
$
|
107,490
|
|
|
$
|
85,572
|
|
(1)
|
Long-lived assets consist of property and equipment.
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Grant date fair value
|
$
|
40.45
|
|
|
$
|
57.19
|
|
|
$
|
60.29
|
|
Volatility
|
39
|
%
|
|
39
|
%
|
|
45
|
%
|
|||
Expected term (years)
|
4.2
|
|
|
4.2
|
|
|
4.3
|
|
|||
Range of risk-free rates
|
0.8-1.6%
|
|
|
1.1-1.5%
|
|
|
1.1-1.4%
|
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Selling, general and administrative
|
$
|
79,037
|
|
|
$
|
74,653
|
|
|
$
|
55,083
|
|
Research and development
|
15,296
|
|
|
13,356
|
|
|
12,179
|
|
|||
Cost of product sales
|
4,438
|
|
|
3,541
|
|
|
2,376
|
|
|||
Total share-based compensation expense, pre-tax
|
98,771
|
|
|
91,550
|
|
|
69,638
|
|
|||
Income tax benefit from share-based compensation expense (1)
|
(30,022
|
)
|
|
(20,071
|
)
|
|
(13,550
|
)
|
|||
Total share-based compensation expense, net of tax
|
$
|
68,749
|
|
|
$
|
71,479
|
|
|
$
|
56,088
|
|
(1)
|
Following adoption of ASU No. 2016-09, the 2016 income tax benefit includes excess tax benefits recognized.
|
|
Shares
Subject to
Outstanding
Options
(In thousands)
|
|
Weighted-
Average
Exercise
Price
|
|
Weighted-
Average
Remaining
Contractual
Term (Years)
|
|
Aggregate
Intrinsic
Value
(In thousands)
|
|||||
Outstanding at January 1, 2016
|
3,937
|
|
|
$
|
102.81
|
|
|
|
|
|
||
Options granted
|
1,308
|
|
|
125.80
|
|
|
|
|
|
|||
Options exercised
|
(398
|
)
|
|
42.35
|
|
|
|
|
|
|||
Options forfeited
|
(269
|
)
|
|
142.50
|
|
|
|
|
|
|||
Options expired
|
(65
|
)
|
|
167.31
|
|
|
|
|
|
|||
Outstanding at December 31, 2016
|
4,513
|
|
|
111.52
|
|
|
7.2
|
|
$
|
104,546
|
|
|
Vested and expected to vest at December 31, 2016
|
4,288
|
|
|
110.09
|
|
|
7.1
|
|
104,417
|
|
||
Exercisable at December 31, 2016
|
2,541
|
|
|
90.06
|
|
|
6.1
|
|
101,401
|
|
|
Number of RSUs (in thousands)
|
|
Weighted-
Average Grant-Date Fair Value |
|
Weighted-
Average Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value (In thousands) |
|||||
Outstanding at January 1, 2016
|
1,054
|
|
|
$
|
129.40
|
|
|
|
|
|
||
RSUs granted
|
519
|
|
|
125.79
|
|
|
|
|
|
|||
RSUs released
|
(450
|
)
|
|
105.09
|
|
|
|
|
|
|||
RSUs forfeited
|
(126
|
)
|
|
137.25
|
|
|
|
|
|
|||
Outstanding at December 31, 2016
|
997
|
|
|
137.50
|
|
|
1.3
|
|
$
|
108,730
|
|
|
Termination Benefits
|
|
Facility Closure Costs
|
|
Total
|
||||||
Balance at December 31, 2013
|
$
|
—
|
|
|
$
|
252
|
|
|
$
|
252
|
|
Expense
|
1,823
|
|
|
118
|
|
|
1,941
|
|
|||
Payments
|
—
|
|
|
(252
|
)
|
|
(252
|
)
|
|||
Balance at December 31, 2014
|
1,823
|
|
|
118
|
|
|
1,941
|
|
|||
Expense
|
1,469
|
|
|
172
|
|
|
1,641
|
|
|||
Payments
|
(2,187
|
)
|
|
(290
|
)
|
|
(2,477
|
)
|
|||
Balance at December 31, 2015
|
1,105
|
|
|
—
|
|
|
1,105
|
|
|||
Expense
|
1,516
|
|
|
—
|
|
|
1,516
|
|
|||
Payments
|
(2,590
|
)
|
|
—
|
|
|
(2,590
|
)
|
|||
Balance at December 31, 2016
|
$
|
31
|
|
|
$
|
—
|
|
|
$
|
31
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Current
|
|
|
|
|
|
||||||
Ireland
|
$
|
26,420
|
|
|
$
|
29,748
|
|
|
$
|
29,337
|
|
United States
|
140,061
|
|
|
116,301
|
|
|
97,679
|
|
|||
Other
|
9,918
|
|
|
28,708
|
|
|
16,469
|
|
|||
Total current income tax
|
176,399
|
|
|
174,757
|
|
|
143,485
|
|
|||
Deferred, exclusive of other components below
|
|
|
|
|
|
||||||
Ireland
|
(7,776
|
)
|
|
(6,655
|
)
|
|
(3,508
|
)
|
|||
United States
|
(9,120
|
)
|
|
332
|
|
|
(15,003
|
)
|
|||
Other
|
(13,720
|
)
|
|
(40,532
|
)
|
|
(30,743
|
)
|
|||
Total deferred, exclusive of other components
|
(30,616
|
)
|
|
(46,855
|
)
|
|
(49,254
|
)
|
|||
Deferred, change in tax rates
|
|
|
|
|
|
||||||
United States
|
109
|
|
|
294
|
|
|
—
|
|
|||
Other
|
(10,656
|
)
|
|
(21,797
|
)
|
|
—
|
|
|||
Total deferred, change in tax rates
|
(10,547
|
)
|
|
(21,503
|
)
|
|
—
|
|
|||
Total deferred income tax benefit
|
(41,163
|
)
|
|
(68,358
|
)
|
|
(49,254
|
)
|
|||
Total income tax provision
|
$
|
135,236
|
|
|
$
|
106,399
|
|
|
$
|
94,231
|
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Statutory income tax rate
|
12.5
|
%
|
|
12.5
|
%
|
|
12.5
|
%
|
Foreign income tax rate differential
|
16.7
|
%
|
|
19.1
|
%
|
|
50.0
|
%
|
Change in unrecognized tax benefits
|
3.3
|
%
|
|
3.6
|
%
|
|
6.2
|
%
|
Financing costs
|
(2.9
|
)%
|
|
(0.4
|
)%
|
|
0.7
|
%
|
Research and other tax credits
|
(2.8
|
)%
|
|
(3.8
|
)%
|
|
(9.4
|
)%
|
Deduction on subsidiary equity
|
(2.4
|
)%
|
|
(2.7
|
)%
|
|
(7.5
|
)%
|
Acquisition-related costs
|
2.1
|
%
|
|
—
|
%
|
|
3.1
|
%
|
Non-deductible compensation
|
1.8
|
%
|
|
1.9
|
%
|
|
4.6
|
%
|
Change in tax rate
|
(1.8
|
)%
|
|
(4.5
|
)%
|
|
—
|
%
|
Excess tax benefits from share-based compensation
|
(1.5
|
)%
|
|
—
|
%
|
|
—
|
%
|
Change in valuation allowance
|
(0.1
|
)%
|
|
(0.6
|
)%
|
|
5.7
|
%
|
Change in estimates
|
—
|
%
|
|
(1.0
|
)%
|
|
(3.0
|
)%
|
Other
|
0.5
|
%
|
|
0.3
|
%
|
|
(0.7
|
)%
|
Effective income tax rate
|
25.4
|
%
|
|
24.4
|
%
|
|
62.2
|
%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
202,758
|
|
|
$
|
57,091
|
|
Tax credit carryforwards
|
114,192
|
|
|
36,797
|
|
||
Intangible assets
|
15,965
|
|
|
25,384
|
|
||
Share-based compensation
|
27,522
|
|
|
20,050
|
|
||
Accruals
|
38,763
|
|
|
32,355
|
|
||
Other
|
57,893
|
|
|
49,420
|
|
||
Total deferred tax assets
|
457,093
|
|
|
221,097
|
|
||
Valuation allowance
|
(53,184
|
)
|
|
(33,949
|
)
|
||
Net deferred tax assets
|
403,909
|
|
|
187,148
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Acquired intangible assets
|
(910,460
|
)
|
|
(307,356
|
)
|
||
Other
|
(35,122
|
)
|
|
(33,137
|
)
|
||
Total deferred tax liabilities
|
(945,582
|
)
|
|
(340,493
|
)
|
||
Net deferred tax liabilities
|
$
|
(541,673
|
)
|
|
$
|
(153,345
|
)
|
|
Year Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Non-current deferred tax assets
|
$
|
15,060
|
|
|
$
|
130,148
|
|
Non-current deferred tax liabilities
|
(556,733
|
)
|
|
(283,493
|
)
|
||
Net deferred tax liabilities
|
$
|
(541,673
|
)
|
|
$
|
(153,345
|
)
|
|
December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Balance at the beginning of the year
|
$
|
66,385
|
|
|
$
|
40,802
|
|
|
$
|
21,637
|
|
Increases related to current year tax positions
|
26,873
|
|
|
23,664
|
|
|
19,837
|
|
|||
Increases related to prior year tax positions
|
1,191
|
|
|
2,833
|
|
|
—
|
|
|||
Decreases related to prior year tax positions
|
(255
|
)
|
|
(646
|
)
|
|
(672
|
)
|
|||
Lapse of the applicable statute of limitations
|
(3,284
|
)
|
|
(268
|
)
|
|
—
|
|
|||
Balance at the end of the year
|
$
|
90,910
|
|
|
$
|
66,385
|
|
|
$
|
40,802
|
|
|
2016
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Revenues
|
$
|
336,010
|
|
|
$
|
381,161
|
|
|
$
|
374,181
|
|
|
$
|
396,621
|
|
Gross margin (1)
|
310,477
|
|
|
355,130
|
|
|
347,310
|
|
|
358,958
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc (2)
|
75,812
|
|
|
114,502
|
|
|
89,828
|
|
|
116,689
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, basic (2)
|
1.24
|
|
|
1.89
|
|
|
1.49
|
|
|
1.95
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, diluted (2)
|
1.21
|
|
|
1.85
|
|
|
1.45
|
|
|
1.91
|
|
|
2015
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Revenues
|
$
|
309,303
|
|
|
$
|
333,747
|
|
|
$
|
340,872
|
|
|
$
|
340,881
|
|
Gross margin (1)
|
278,737
|
|
|
310,293
|
|
|
310,369
|
|
|
314,894
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc
|
70,700
|
|
|
88,114
|
|
|
87,960
|
|
|
82,761
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, basic
|
1.16
|
|
|
1.44
|
|
|
1.43
|
|
|
1.35
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, diluted
|
1.12
|
|
|
1.40
|
|
|
1.39
|
|
|
1.32
|
|
(1)
|
Gross margin is computed by subtracting cost of product sales (excluding amortization and impairment of intangible assets) from product sales, net.
|
(2)
|
As described in Note 2, we elected to early adopt ASU No. 2016-09 in the fourth quarter of 2016 retroactive to the beginning of the fiscal year. Previously reported quarterly net income attributable to Jazz Pharmaceuticals plc and the related per-share measures for the first three quarters of 2016 have been recast to reflect the adoption of ASU No. 2016-09. Below is a reconciliation of the net income attributable to Jazz Pharmaceuticals plc and the related per-share measures as previously reported in our quarterly reports on Form 10-Q to the recast amounts reported above.
|
|
2016
|
||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
||||||
Net income attributable to Jazz Pharmaceuticals plc, as previously reported
|
$
|
74,121
|
|
|
$
|
111,282
|
|
|
$
|
87,145
|
|
Adoption of ASU No. 2016-09
|
1,691
|
|
|
3,220
|
|
|
2,683
|
|
|||
Net income attributable to Jazz Pharmaceuticals plc, as recast
|
$
|
75,812
|
|
|
$
|
114,502
|
|
|
$
|
89,828
|
|
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - basic, as previously reported
|
$
|
1.21
|
|
|
$
|
1.84
|
|
|
$
|
1.44
|
|
Adoption of ASU No. 2016-09
|
0.03
|
|
|
0.05
|
|
|
0.05
|
|
|||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - basic, as recast
|
$
|
1.24
|
|
|
$
|
1.89
|
|
|
$
|
1.49
|
|
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - diluted, as previously reported
|
$
|
1.19
|
|
|
$
|
1.80
|
|
|
$
|
1.41
|
|
Adoption of ASU No. 2016-09
|
0.02
|
|
|
0.05
|
|
|
0.04
|
|
|||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share - diluted, as recast
|
$
|
1.21
|
|
|
$
|
1.85
|
|
|
$
|
1.45
|
|
•
|
Upfront and milestone payments of
$8.8 million
and
$15.0 million
in the first and third quarters of 2016, respectively, and
$25.0 million
in the third quarter of 2015;
|
•
|
Transaction costs and integration related costs of
$2.2 million
,
$10.8 million
and
$0.7 million
in the second, third and fourth quarters of 2016, respectively;
|
•
|
Expenses related to certain legal proceedings and restructuring of
$6.1 million
in the first quarter of 2016 and
$0.5 million
and
$1.1 million
in the first and fourth quarters of 2015, respectively;
|
•
|
A one-time charge of
$11.6 million
in respect of a contract termination in the fourth quarter of 2016;
|
•
|
A loss on extinguishment and modification of debt of
$0.6 million
in the third quarter of 2016 and
$16.8 million
in the second quarter of 2015;
|
•
|
Impairment charges of
$31.5 million
in the fourth quarter of 2015, which resulted from our decision to terminate a pivotal Phase 2 clinical trial of JZP-416; and
|
•
|
A one-time charge of
$18.0 million
in the fourth quarter of 2015 for settlement of a contract claim that was originally asserted against Azur Pharma prior to the Azur Merger.
|
|
|
|
Balance at
beginning
of period
|
|
Additions
charged to
costs and
expenses
|
|
Other Additions
|
|
Deductions
|
|
Balance at
end of
period
|
||||||||||
For the year ended December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
(1)
|
|
$
|
489
|
|
|
$
|
168
|
|
|
$
|
—
|
|
|
$
|
(370
|
)
|
|
$
|
287
|
|
Allowance for sales discounts
|
(1)
|
|
181
|
|
|
1,334
|
|
|
—
|
|
|
(1,397
|
)
|
|
118
|
|
|||||
Allowance for chargebacks
|
(1)
|
|
3,023
|
|
|
41,991
|
|
|
—
|
|
|
(40,265
|
)
|
|
4,749
|
|
|||||
Deferred tax asset valuation allowance
|
(2)(3)(4)
|
|
33,949
|
|
|
19,328
|
|
|
5,544
|
|
|
(5,637
|
)
|
|
53,184
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
For the year ended December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
(1)
|
|
$
|
530
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(41
|
)
|
|
$
|
489
|
|
Allowance for sales discounts
|
(1)
|
|
238
|
|
|
2,900
|
|
|
—
|
|
|
(2,957
|
)
|
|
181
|
|
|||||
Allowance for chargebacks
|
(1)
|
|
2,715
|
|
|
39,079
|
|
|
—
|
|
|
(38,771
|
)
|
|
3,023
|
|
|||||
Deferred tax asset valuation allowance
|
(2)(3)(4)
|
|
29,697
|
|
|
5,044
|
|
|
1,888
|
|
|
(2,680
|
)
|
|
33,949
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
For the year ended December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
(1)
|
|
$
|
594
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(64
|
)
|
|
$
|
530
|
|
Allowance for sales discounts
|
(1)
|
|
378
|
|
|
3,794
|
|
|
—
|
|
|
(3,934
|
)
|
|
238
|
|
|||||
Allowance for chargebacks
|
(1)
|
|
2,708
|
|
|
28,614
|
|
|
—
|
|
|
(28,607
|
)
|
|
2,715
|
|
|||||
Deferred tax asset valuation allowance
|
(2)(3)
|
|
20,691
|
|
|
18,971
|
|
|
—
|
|
|
(9,965
|
)
|
|
29,697
|
|
(1)
|
Shown as a reduction of accounts receivable. Charges related to sales discounts and chargebacks are reflected as a reduction of revenue.
|
(2)
|
Additions to the deferred tax asset valuation allowance relate to movements on certain U.S. state and other foreign deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal.
|
(3)
|
Deductions to the deferred tax asset valuation allowance include movements relating to utilization of NOLs and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns.
|
(4)
|
Other additions to the deferred tax asset valuation allowance relate to currency translation adjustments recorded directly in other comprehensive income and a valuation allowance recognized on purchase accounting.
|
Exhibit
Number
|
|
Description of Document
|
|
2.1
|
|
Agreement and Plan of Merger and Reorganization, dated as of September 19, 2011, by and among Azur Pharma Limited (now Jazz Pharmaceuticals plc), Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500) filed with the SEC on September 19, 2011).
|
|
2.2
|
|
Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
2.3
|
|
Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on April 27, 2012).
|
|
2.4
|
|
Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 12, 2012).
|
|
2.5
|
|
Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l. and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K/A (File No. 001-33500), as filed with the SEC on December 20, 2013).
|
|
2.6†
|
|
Asset Purchase Agreement, dated January 13, 2014, by and among Jazz Pharmaceuticals International III Limited, Aerial BioPharma, LLC and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 13, 2014).
|
|
2.7†
|
|
Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 5, 2014).
|
|
2.8
|
|
Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on March 23, 2015).
|
|
2.9
|
|
Agreement and Plan of Merger, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc., and Celator Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on May 31, 2016).
|
|
3.1
|
|
Amended and Restated Memorandum and Articles of Association of Jazz Pharmaceuticals plc, as amended on August 4, 2016 (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
4.1
|
|
Reference is made to Exhibit 3.1.
|
|
4.2A
|
|
Investor Rights Agreement, dated July 7, 2009 by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 10.88 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on July 7, 2009).
|
|
4.2B
|
|
Assignment, Assumption and Amendment Agreement, dated as of January 18, 2012, by and among Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and the other parties named therein (incorporated herein by reference to Exhibit 4.7B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
4.2C
|
|
Indenture, dated as of August 13, 2014, by and among Jazz Pharmaceuticals plc, Jazz Investments I Limited and U.S. Bank National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
4.2D
|
|
Form of 1.875% Exchangeable Senior Note due 2021 (incorporated herein by reference to Exhibit 4.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
10.1†
|
|
Supply Agreement, dated as of April 1, 2010, by and between Jazz Pharmaceuticals, Inc. and Siegfried (USA) Inc. (incorporated herein by reference to Exhibit 10.54 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2010, as filed with the SEC on May 6, 2010).
|
|
10.2†
|
|
Master Services Agreement, dated April 15, 2011, by and between Jazz Pharmaceuticals, Inc., CuraScript, Inc. and Express Scripts Specialty Distribution Services, Inc. (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2011, as filed with the SEC on May 9, 2011).
|
|
10.3†
|
|
Royalty Bearing Licence Agreement and Supply Agreement Re Erwinia-Derived Asparaginase, dated July 22, 2005, between Public Health England (formerly Health Protection Agency) and EUSA Pharma SAS (formerly OPi, S.A.), as amended on each of December 22, 2009, March 23, 2012 and August 8, 2012 (incorporated herein by reference to Exhibit 10.11 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q/A (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 9, 2012).
|
|
10.4
|
|
Novation Agreement relating to Royalty Bearing Licence Agreement and Supply Agreement re Erwinia-Derived Asparaginase, dated as of May 13, 2015, by and among EUSA Pharma SAS, the Secretary of State for Health acting through Public Health England and Porton Biopharma Limited (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.5†
|
|
Master Manufacturing Services Agreement, dated as of October 1, 2015, by and between Jazz Pharmaceuticals Ireland Limited and Patheon Pharmaceuticals Inc. (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.6A
|
|
Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc's Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 18, 2015).
|
|
10.6B
|
|
Amendment No. 1, dated as of July 12, 2016, to Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.7A
|
|
Commercial Lease, dated as of June 2, 2004, by and between Jazz Pharmaceuticals, Inc. and The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.52 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on March 27, 2007).
|
|
10.7B
|
|
First Amendment of Lease, dated June 1, 2009, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.86 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 4, 2009).
|
|
10.7C
|
|
Second Amendment of Lease, dated February 28, 2012, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.31 in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
10.8
|
|
Lease, dated May 8, 2012, by and between John Ronan and Castle Cove Property Developments Limited and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.9
|
|
Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.10+
|
|
Form of Indemnification Agreement between Jazz Pharmaceuticals plc and its officers and directors (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
10.11+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Suzanne Sawochka Hooper (incorporated herein by reference to Exhibit 10.19 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012).
|
|
10.12+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Matthew Young (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2014, as filed with the SEC on May 8, 2014).
|
|
10.13A+
|
|
Employment Agreement by and between EUSA Pharma Inc. and Iain McGill (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.13B+
|
|
Amendment to Employment Agreement by and between Iain McGill and EUSA Pharma (Europe) Limited (incorporated herein by reference to Exhibit 10.15B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.13C+
|
|
Amended and Restated Schedule 3 to Employment Agreement by and between Jazz Pharmaceuticals UK Ltd and Iain McGill (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.13D+
|
|
Change in Control Stock Award Acceleration Agreement by and between Jazz Pharmaceuticals plc and Iain McGill (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.14+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Michael Miller (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15A+
|
|
Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15B+
|
|
Amendment to Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.17B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.15C+
|
|
Amended and Restated Schedule 3 to Employment Agreement by and between Jazz Pharmaceuticals Ireland Ltd. and Paul Treacy (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.15D+
|
|
Change in Control Stock Award Acceleration Agreement by and between Jazz Pharmaceuticals plc and Paul Treacy (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.16+
|
|
Amended and Restated Offer Letter, dated as of July 29, 2015, from Jazz Pharmaceuticals, Inc. to Karen Smith, M.D., Ph.D. ((incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2015, as filed with the SEC on November 9, 2015).
|
|
10.17A+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.3 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.17B+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.3B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.17C+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27C in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17D+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (Irish) under Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17E+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27F in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17G+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.17H+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18A+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.18B+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.39B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.18C+
|
|
Form of Option Grant Notice and Form of Stock Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18D+
|
|
Form of Stock Option Grant Notice and Form of Option Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18E+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18G+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18H+
|
|
Form of Non-U.S. Restricted Stock Unit Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28H in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18I+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Option Grant Notice and Form of U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18J+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18K+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18L+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18M+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2016, as filed with the SEC on May 10, 2016).
|
|
10.18N+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2016, as filed with the SEC on May 10, 2016).
|
|
10.18O+
|
|
Amended and Restated 2011 Equity Incentive Plan (approved August 4, 2016) (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.18P+
|
|
Amended and Restated 2011 Equity Incentive Plan (approved November 3, 2016) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.18Q+
|
|
Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.18R+
|
|
Form of U.S. Option Grant Notice and Form of U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.18S+
|
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.19+
|
|
Jazz Pharmaceuticals plc Amended and Restated Directors Deferred Compensation Plan (incorporated herein by reference to Exhibit 99.6 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20A+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 99.4 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20B+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 10.30B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.20C+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved August 1, 2013) (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.20D+
|
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan (approved August 4, 2016) (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.20E+
|
|
Amended and Restated 2007 Non-Employee Directors Stock Award Plan (approved November 3, 2016) (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.20F+
|
|
Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Award Plan (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.20G+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated Non-Employee Directors 2007 Stock Award Plan (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2016, as filed with the SEC on November 8, 2016).
|
|
10.21A+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan, as amended and restated (incorporated herein by reference to Exhibit 10.31A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.21B+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan Sub-Plan Governing Purchase Rights to Participants in the Republic of Ireland (incorporated by reference herein to Exhibit 10.14C in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012 ).
|
|
10.22A+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (approved November 4, 2015) (incorporated herein by reference to Exhibit 10.22B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.22B+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (approved November 3, 2016).
|
|
10.22C+
|
|
Jazz Pharmaceuticals Cash Bonus Plan for International Affiliates (2014) (incorporated herein by reference to Exhibit 10.24D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2013, as filed with the SEC on February 25, 2014).
|
|
10.22D+
|
|
Jazz Pharmaceuticals Cash Bonus Plan (Ireland and Other Specified Affiliates) (Calendar Year 2016) (incorporated herein by reference to Exhibit 10.22D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.22E+
|
|
Jazz Pharmaceuticals Cash Bonus Plan (Ireland and Other Specified Affiliates) (Calendar Year 2017).
|
|
10.23+
|
|
Jazz Pharmaceuticals plc Amended and Restated Executive Change in Control and Severance Benefit Plan (approved February 10, 2016) (incorporated herein by reference to Exhibit 10.23 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2015, as filed with the SEC on February 23, 2016).
|
|
10.24+
|
|
Jazz Pharmaceuticals plc 2015 Executive Officer Compensation Arrangements (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2015, as filed with the SEC on May 7, 2015).
|
|
10.25A+
|
|
Jazz Pharmaceuticals plc Non-Employee Director Compensation Policy (approved April 30, 2015) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.25B+
|
|
Amended and Restated Non-Employee Director Compensation Policy (approved May 5, 2016) (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2016, as filed with the SEC on August 9, 2016).
|
|
10.27
|
|
Tender and Support Agreement, dated as of May 27, 2016, by and among Jazz Pharmaceuticals plc, Plex Merger Sub, Inc. and each of the persons set forth on Schedule A attached thereto (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on May 31, 2016).
|
|
21.1
|
|
Subsidiaries of Jazz Pharmaceuticals plc.
|
|
23.1
|
|
Consent of KPMG, Independent Registered Public Accounting Firm.
|
|
24.1
|
|
Power of Attorney (included on the signature page hereto).
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
32.1*
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
+
|
Indicates management contract or compensatory plan.
|
†
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
*
|
The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
1.
|
Purpose of the Plan.
|
2.
|
Eligibility.
|
3.
|
Target Bonus.
|
Position
|
Target Bonus
(Percent of
Base Salary)
|
Chairman of the Board, Chief Executive Officer, President
|
100%
|
Executive Vice President
|
55%
|
Senior Vice President who is an Executive Committee Member or is a Section 16 Officer
|
45%
|
Senior Vice President who is not an Executive Committee Member or a Section 16 Officer
|
40%
|
Vice President
|
35%
|
Executive Director
|
30%
|
Senior Director
|
25%
|
Director
|
22%
|
Associate Director
|
20%
|
Senior Manager
|
18%
|
Manager
|
15%
|
Analyst
|
12%
|
Support
|
8%
|
4.
|
Bonus Pool and Bonuses.
|
5.
|
Bonus.
|
6.
|
Termination of Employment; Death; Retirement; Permanent Disability.
|
7.
|
Payment of Bonuses.
|
8.
|
Withholding of Taxes.
|
9.
|
Plan Amendments.
|
10.
|
No Employment Rights.
|
11.
|
Plan Administration.
|
12.
|
Definitions.
|
1.
|
Purpose of the Plan.
|
2.
|
Eligibility.
|
3.
|
Target Bonus.
|
Position
|
Target Bonus
(Percent of
Base Salary)
|
Chairman of the Board, Chief Executive Officer, President
|
100%
|
Executive Vice President
|
55%
|
Senior Vice President who is an Executive Committee Member or is a Section 16 Officer
|
45%
|
Senior Vice President who is not an Executive Committee Member or a Section 16 Officer
|
40%
|
Vice President
|
35%
|
Executive Director
|
30%
|
Senior Director
|
25%
|
Director
|
22%
|
Associate Director
|
20%
|
Senior Manager
|
18%
|
Manager
|
15%
|
Analyst
|
12%
|
Support
|
8%
|
4.
|
Bonus Pool and Bonuses.
|
5.
|
Bonus.
|
6.
|
Termination of Employment; Death; Retirement; Permanent Disability.
|
7.
|
Payment of Bonuses.
|
8.
|
Withholding of Taxes and Mandatory Contributions.
|
9.
|
Plan Amendments.
|
10.
|
No Employment Rights; No Acquired Rights.
|
11.
|
Plan Administration.
|
12.
|
Definitions.
|
Name of Subsidiary
|
State or Jurisdiction of Incorporation or Organization
|
|
|
|
|
Jazz Pharmaceuticals Ireland Limited
|
Ireland
|
Jazz Financing I Designated Activity Company
|
Ireland
|
Jazz Capital Limited
|
Ireland
|
Jazz Pharmaceuticals, Inc.
|
Delaware
|
Celator Pharmaceuticals, Inc.
|
Delaware
|
Jazz Pharmaceuticals Europe Holdings Limited
|
Gibraltar
|
Jazz Pharmaceuticals France SAS
|
France
|
Jazz Pharmaceuticals France Holdings SAS
|
France
|
Jazz Pharmaceuticals Lux S.à r.l.
|
Luxembourg
|
Gentium S.R.L.
|
Italy
|
Jazz Pharmaceuticals Italy S.R.L.
|
Italy
|
1.
|
I have reviewed this Annual Report on Form 10-K of Jazz Pharmaceuticals public limited company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 28, 2017
|
By:
|
/s/ Bruce C. Cozadd
|
|
|
Bruce C. Cozadd
Chairman and Chief Executive Officer and Director
|
1.
|
I have reviewed this Annual Report on Form 10-K of Jazz Pharmaceuticals public limited company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 28, 2017
|
By:
|
/s/ Matthew P. Young
|
|
|
Matthew P. Young
Executive Vice President and Chief Financial Officer
|
1.
|
The Company’s Annual Report on Form 10-K for the year ended
December 31, 2016
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Bruce C. Cozadd
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Bruce C. Cozadd
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Chairman and Chief Executive Officer and Director
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/s/ Matthew P. Young
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Matthew P. Young
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Executive Vice President and Chief Financial Officer
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(1)
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This certification accompanies the Annual Report on Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Jazz Pharmaceuticals public limited company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Jazz Pharmaceuticals public limited company and will be retained by Jazz Pharmaceuticals public limited company and furnished to the Securities and Exchange Commission or its staff upon request.
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