ý
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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 1.
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Business
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•
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Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
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•
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Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
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•
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Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
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Caphosol
®
(supersaturated calcium phosphate rinse), indicated for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy;
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Quadramet
®
(samarium sm 153 lexidronam injection), indicated for the treatment of pain in patients whose cancer has spread to the bones;
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•
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ProstaScint
®
(capromab pendetide), indicated for imaging the extent and spread of prostate cancer;
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•
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Niravam
®
(alprazolam orally disintegrating tablets), indicated for the treatment of generalized anxiety disorder and also indicated for the treatment of panic disorder, with or without agoraphobia; and
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•
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Parcopa
®
(carbidopa and levodopa orally disintegrating tablets), indicated for the treatment of symptoms associated with idiopathic Parkinson’s disease.
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Caphosol;
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•
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Collatamp
®
(lyophilized collagen implant impregnated with the aminoglycoside antibiotic gentamicin), a surgical implant impregnated with the antibiotic gentamicin;
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•
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Fomepizole
®
(fomepizole), indicated for the treatment of ethylene glycol poisoning;
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Kidrolase
®
(Escherichia coli L-asparaginase), indicated in the treatment of ALL, Leukaemic meningitis and Non-Hodgkin’s lymphoma;
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•
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Xenazine
®
(tetrabenazine), indicated for the treatment of movement disorders associated with Huntington’s chorea and hemiballismus; and
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•
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Custodiol
®
(solution HTK), a ready to use solution used in organ transplantation for rinsing and hypothermic storage for preservation of organs (heart, kidney, liver and pancreas) since their removal from the donor to the graft in the recipient.
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•
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Xyrem
®
(sodium oxybate) oral solution
. Xyrem is the only product approved for the treatment of both cataplexy and excessive daytime sleepiness in patients with narcolepsy. No product other than Xyrem is approved for the treatment of cataplexy. The only other products approved by the FDA for the treatment of excessive daytime sleepiness in patients with narcolepsy are Provigil
®
(modafinil) and Nuvigil
®
(armodafinil), which are marketed by Teva, and the generic versions of Provigil. Provigil, its generic equivalents and Nuvigil are also approved for the treatment of excessive daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. Xyrem is often used in conjunction with stimulants and wakefulness promoting drugs, which are administered during the day.
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•
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Erwinaze
®
(asparaginase Erwinia chrysanthemi)
. 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 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 for ALL that may not include asparaginase-containing regimens. Any of these potential new treatments could compete with, or reduce the market for, Erwinaze. As a biologic product, Erwinaze also faces potential competition from biosimilar products.
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•
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Prialt
®
(ziconotide) intrathecal infusion
. Prialt is the only FDA-approved non-opioid intrathecal analgesic. It competes with intrathecally administered morphine, which is the only other product approved by the FDA for the intrathecal treatment of severe chronic pain. Other drugs are also used intrathecally by physicians, including hydromorphone, clonidine, baclofen and sufentanil.
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FazaClo
®
LD (clozapine, USP) Orally Disintegrating Tablet, FazaClo
®
HD (clozapine, USP) Orally Disintegrating Tablet and Versacloz
TM
(clozapine, USP) oral suspension
. FazaClo LD, the authorized generic version of FazaClo LD launched in 2012 and FazaClo HD are the only orally disintegrating tablet formulations of clozapine available. FazaClo LD competes against the authorized generic. The bulk of prescriptions for clozapine are generic tablets, which compete with both FazaClo LD and FazaClo HD. In addition, prior to prescribing clozapine, most physicians choose other branded products as treatment options, including Seroquel
®
, marketed by AstraZeneca, Risperdal
®
, marketed by Janssen, and Zyprexa
®
, marketed by Eli Lilly. Versacloz is currently the only oral suspension formation of clozapine approved by the FDA.
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Luvox CR
®
(fluvoxamine maleate) Extended-Release Capsules
. The market for drugs to treat obsessive compulsive disorder is very fragmented. We believe that, in addition to Luvox CR, a large number of branded and generic drugs are used for the treatment of this disorder. Seven branded products, including Luvox CR, and generic equivalents of many of these, have been approved by the FDA for the treatment of obsessive compulsive disorder, and we believe that other products are regularly used to treat this disorder. A generic version of Luvox CR could be introduced as soon as the FDA approves Anchen’s ANDA.
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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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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 supply commercial quantities of a product to the market; and
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our ability to recruit and retain skilled employees.
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Xyrem
®
(sodium oxybate) oral solution
. Xyrem is covered by eleven U.S. patents that expire at various times from December 2019 to June 2024. These patents relate to Xyrem’s stable and microbially resistant formulation, its manufacturing process, and its method of use, including its restricted distribution system. Nine of these eleven patents are listed in the Orange Book. Of the patents listed in the Orange Book, two are formulation patents expiring in July 2020; four are method of use patents covering the distribution of Xyrem, three of which expire in June 2024 and one of which expires in December 2022; two are method of use patents covering Xyrem’s use in narcolepsy, both of which expire in December 2019; and one is formulation and method of use patent expiring in December 2019. A process patent and a distribution system patent not listed in the Orange Book also cover the product and expire in December 2019 and June 2024, respectively. A Xyrem formulation patent has issued in 19 other countries and will expire in December 2019. This formulation patent is currently pending in two additional countries. In addition to our issued patents, we have patent applications relating to Xyrem pending in the United States. The patent laws of non-U.S. countries differ from those in United States, and the degree of protection afforded by non-U.S. patents may be different from the protection offered by U.S. patents. Two companies have notified us that they have filed ANDAs with the FDA seeking FDA approval to market a generic version of Xyrem. We initiated lawsuits against each of these companies and are currently involved in litigation with both companies.
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•
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Prialt
®
(ziconotide) intrathecal infusion
. Prialt is covered by a portfolio of four U.S. patents for a formulation and methods of use. Two of these patents are listed in the Orange Book. These patents will expire from June 2015 to December 2016. Also, there are four non-U.S. patents that will expire in June 2016. There are also six additional U.S. patents issued on a formulation containing Prialt and other active ingredients and methods for their use. These U.S. patents will expire in October 2024. We also have equivalent non-U.S. applications to these additional patents pending in Canada and Japan that, if issued, would expire in October 2024.
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FazaClo
®
LD (clozapine, USP) Orally Disintegrating Tablet and FazaClo
®
HD (clozapine, USP) Orally Disintegrating Tablet.
FazaClo LD and FazaClo HD are covered by three U.S. formulation patents. All are licensed by us, one from Ethypharm, expiring in December 2017, and the other two from CIMA, expiring April 2018. The three patents are listed in the Orange Book. The two patents licensed from CIMA are subject to ongoing re-examination proceedings at the USPTO, as described in “Marketed Products” in this Item 1. As part of its settlement with Teva in 2011, Azur Pharma granted a sublicense to an affiliate of Teva of its rights to have manufactured, market and sell a generic version of both FazaClo LD and FazaClo HD. The sublicenses for FazaClo LD commenced in July 2012, and the sublicense for FazaClo HD will commence in May 2015, or earlier upon the occurrence of certain events.
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•
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Versacloz
TM
(clozapine, USP) oral suspension
. Versacloz is covered by a U.S. formulation patent and a pending U.S. patent application that we license from Douglas Pharmaceuticals. The patent expires in May 2028.
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•
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Luvox CR
®
(fluvoxamine maleate) Extended-Release Capsules
. Luvox CR is covered by a U.S. formulation patent owned by Alkermes that is listed in the Orange Book and will expire in 2020. A continuation application is pending in the United States. Pursuant to our settlement agreements with three companies, we granted a sublicense to each of these companies of our rights to have manufactured, market and sell a generic version of Luvox CR in the United States. The first of such sublicenses commenced in February 2013, and a generic version of Luvox CR could be introduced as soon as the FDA approves the generic company’s ANDA. The other two sublicenses will commence in April 2014, or earlier if a generic version of Luvox CR receives FDA approval.
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•
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Product candidate
. Asparec
®
(mPEG-r-crisantaspase) is not yet covered by any issued patents. We have rights to patent applications for Asparec pending in the United States and many other countries that, if issued, would expire in July 2030.
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Item 1A.
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Risk Factors
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the potential introduction of a generic version of Xyrem;
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changed or increased regulatory restrictions, including changes to our risk management program, and the terms of the final REMS documents, for Xyrem, or regulatory actions by the FDA as a result of, or related to the matters raised in, the warning letter we received from the FDA in October 2011 or the Form FDA 483 we received in May 2012, as discussed in more detail in the risk factors below;
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our manufacturing partners’ ability to obtain sufficient quota from the DEA to satisfy our needs for Xyrem;
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any supply, manufacturing or distribution problems arising with any of our manufacturing and distribution partners, all of whom are sole source providers for us;
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the availability of reimbursement from third party payors;
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changes in healthcare laws and policy, including changes in requirements for rebates, reimbursement and coverage by federal healthcare programs;
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continued acceptance of Xyrem as safe and effective by physicians and patients, even in the face of negative publicity that surfaces from time to time; and
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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.
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the risk that our lack of experience in new markets, including the oncology market, will not allow us to achieve growth in, or maintain current levels of, sales of our products in such markets;
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the strain on, and need to expand, our existing operational, technical, financial and administrative infrastructure, including our financial controls and reporting systems and procedures and disaster recovery procedures, in connection with integrating three different businesses and operations;
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the challenges in controlling additional costs and expenses in connection with and as a result of the acquisitions, including professional fees to comply with corporate and tax laws and financial reporting requirements in a number of countries in Europe, costs and expenses incurred in connection with travel, and additional costs we may incur going forward as a result of our corporate structure that includes an increased number of subsidiaries in multiple additional countries;
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the diversion of our management’s attention to integration of operations; and
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any unanticipated liabilities for activities of or related to Azur Pharma or EUSA Pharma or any of their operations, products or product candidates that occurred prior to the closing of the respective acquisitions or before adequate risk mitigation could be accomplished.
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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 changes to such requirements in one or more countries where we are located or do business;
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country-specific tax laws and regulations;
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complying with 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;
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changes in non-U.S. 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 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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perceived advantages over alternative treatments;
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relative convenience and ease of administration;
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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; and
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the availability of adequate reimbursement by third parties.
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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, or IRB, to conduct a clinical trial at a prospective study site;
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delays 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’s Good Clinical Practices;
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unforeseen safety issues, including negative results from ongoing preclinical studies and adverse events associated
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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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failure of our third-party clinical trial managers to satisfy 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 be able to make products that are similar to our product candidates but that are not covered by the claims of our patents, or for which we are not licensed under our license agreements;
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we or our licensors or partners might not have been the first to make the inventions 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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we or our licensors or partners might not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative products without infringing our intellectual property rights;
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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 future 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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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 competition for our products;
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the costs of our commercial operations;
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the costs of integration activities related to the Azur Merger, the EUSA Acquisition and any future strategic transactions we may engage in;
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the cost of acquiring and/or 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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permit our board of directors to issue one or more series of preferred shares with rights and preferences designated by our board;
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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; and
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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.
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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—2011
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First Quarter
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$
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33.83
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$
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18.85
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Second Quarter
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$
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34.97
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$
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23.50
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Third Quarter
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$
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47.88
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$
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31.87
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Fourth Quarter
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$
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45.81
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$
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34.02
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Calendar Quarter—2012
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First Quarter
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$
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53.10
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$
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37.90
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Second Quarter
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$
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54.50
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$
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40.38
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Third Quarter
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$
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58.94
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$
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43.38
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Fourth Quarter
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$
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60.00
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$
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47.37
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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, 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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Item 6.
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Selected Financial Data
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Year Ended December 31,
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||||||||||||||||||
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2012 (1)
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2011
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2010
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2009
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2008
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||||||||||
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(In thousands, except per share amounts)
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Consolidated Statements of Operations Data:
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||||||||||||||
Revenues:
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||||||||||
Product sales, net
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$
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580,527
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$
|
266,518
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|
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$
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170,006
|
|
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$
|
115,108
|
|
|
$
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64,637
|
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Royalties and contract revenues
|
5,452
|
|
|
5,759
|
|
|
3,775
|
|
|
13,341
|
|
|
2,877
|
|
|||||
Total revenues
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585,979
|
|
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272,277
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|
|
173,781
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|
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128,449
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|
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67,514
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sales (excluding amortization of acquired developed technologies and intangible asset impairment)
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78,425
|
|
|
13,942
|
|
|
13,559
|
|
|
9,638
|
|
|
13,924
|
|
|||||
Selling, general and administrative
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223,882
|
|
|
108,936
|
|
|
68,996
|
|
|
58,652
|
|
|
111,401
|
|
|||||
Research and development
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20,477
|
|
|
14,120
|
|
|
25,612
|
|
|
36,561
|
|
|
69,963
|
|
|||||
Intangible asset amortization
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65,351
|
|
|
7,448
|
|
|
7,825
|
|
|
7,668
|
|
|
12,828
|
|
|||||
Intangible asset impairment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29,763
|
|
|||||
Total operating expenses
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388,135
|
|
|
144,446
|
|
|
115,992
|
|
|
112,519
|
|
|
237,879
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|
|||||
Income (loss) from operations
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197,844
|
|
|
127,831
|
|
|
57,789
|
|
|
15,930
|
|
|
(170,365
|
)
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|||||
Interest expense, net (including $570, $1,183 and $1,179 for the years ended December 31, 2010, 2009 and 2008, respectively, pertaining to a related party)
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(16,869
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)
|
|
(1,600
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)
|
|
(12,724
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)
|
|
(22,766
|
)
|
|
(17,892
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)
|
|||||
Foreign currency loss
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(3,620
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)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Gain on sale of product rights
|
—
|
|
|
—
|
|
|
—
|
|
|
—
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|
|
3,918
|
|
|||||
Loss on extinguishment of debt (including $701 for the year ended December 31, 2010 pertaining to a related party)
|
—
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|
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(1,247
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)
|
|
(12,287
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)
|
|
—
|
|
|
—
|
|
|||||
Income (loss) from continuing operations before income tax benefit
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177,355
|
|
|
124,984
|
|
|
32,778
|
|
|
(6,836
|
)
|
|
(184,339
|
)
|
|||||
Income tax benefit
|
(83,794
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Income (loss) from continuing operations
|
261,149
|
|
|
124,984
|
|
|
32,778
|
|
|
(6,836
|
)
|
|
(184,339
|
)
|
|||||
Income from discontinued operations, net of taxes
|
27,437
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net income (loss)
|
$
|
288,586
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
|
$
|
(6,836
|
)
|
|
$
|
(184,339
|
)
|
Basic income (loss) per ordinary share: (2)
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) from continuing operations
|
$
|
4.61
|
|
|
$
|
3.01
|
|
|
$
|
0.90
|
|
|
$
|
(0.23
|
)
|
|
$
|
(7.19
|
)
|
Income from discontinued operations
|
0.48
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net income (loss)
|
$
|
5.09
|
|
|
$
|
3.01
|
|
|
$
|
0.90
|
|
|
$
|
(0.23
|
)
|
|
$
|
(7.19
|
)
|
Diluted income (loss) per ordinary share: (2)
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) from continuing operations
|
$
|
4.34
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
|
$
|
(0.23
|
)
|
|
$
|
(7.19
|
)
|
Income from discontinued operations
|
0.45
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net income (loss)
|
$
|
4.79
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
|
$
|
(0.23
|
)
|
|
$
|
(7.19
|
)
|
Weighted-average number of ordinary shares outstanding: (2)
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
56,643
|
|
|
41,499
|
|
|
36,343
|
|
|
30,018
|
|
|
25,646
|
|
|||||
Diluted
|
60,195
|
|
|
46,798
|
|
|
39,411
|
|
|
30,018
|
|
|
25,646
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
||||||||||||||||||
|
2012 (1)
|
|
2011
|
|
2010
|
|
2009
|
|
2008
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and marketable securities
|
$
|
387,196
|
|
|
$
|
157,898
|
|
|
$
|
44,794
|
|
|
$
|
15,595
|
|
|
$
|
25,907
|
|
Working capital (deficit)
|
360,034
|
|
|
146,261
|
|
|
14,522
|
|
|
(22,287
|
)
|
|
(129,492
|
)
|
|||||
Total assets
|
1,966,493
|
|
|
253,573
|
|
|
135,729
|
|
|
107,396
|
|
|
117,498
|
|
|||||
Long-term debt, current and non-current (including $6,552 and $6,747 as of December 31, 2009 and 2008, respectively, held by a related party)
|
456,761
|
|
|
—
|
|
|
40,693
|
|
|
114,866
|
|
|
118,534
|
|
|||||
Accumulated deficit
|
(61,296
|
)
|
|
(349,882
|
)
|
|
(474,866
|
)
|
|
(507,644
|
)
|
|
(500,808
|
)
|
|||||
Total shareholders’ equity (deficit)
|
1,121,292
|
|
|
192,788
|
|
|
30,551
|
|
|
(72,830
|
)
|
|
(92,878
|
)
|
(1)
|
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 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 achieves U.S. net sales of $124.5 million or more in 2013. In connection with the EUSA Acquisition, we entered into a $575.0 million credit agreement consisting of a $475.0 million term loan and a $100.0 million revolving credit facility. We used all of the proceeds of the term loan, together with cash on hand, to finance the EUSA Acquisition. 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 EUSA Acquisition, respectively. See Note 3 to the notes to our consolidated financial statements for more information on these transactions.
|
(2)
|
All references to “ordinary shares” refer to Jazz Pharmaceuticals, Inc.’s common stock with respect to the comparative prior year periods and to our ordinary shares with respect to the year ended December 31, 2012. Our earnings per share in the comparative prior year periods were not impacted by the Azur Merger since each share of Jazz Pharmaceuticals, Inc. common stock issued and outstanding immediately prior to the effective time of the Azur Merger was canceled and converted into the right to receive one ordinary share upon the consummation of the Azur Merger.
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
|
•
|
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
|
•
|
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
|
•
|
the challenges of protecting our intellectual property rights;
|
•
|
the need to obtain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to health care cost containment and other austerity measures in the United States and worldwide;
|
•
|
the ongoing regulation and oversight by the FDA, the U.S. Drug Enforcement Administration, or DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals;
|
•
|
the challenges of achieving and maintaining commercial success of our products, such as obtaining sustained acceptance of our products by patients, physicians and payors;
|
•
|
our dependence on sole source suppliers to continue to meet our ongoing commercial needs, especially when our supply demands are growing; and
|
•
|
the difficulty and uncertainty of pharmaceutical product development and the uncertainty of clinical success and regulatory approval.
|
|
2012
|
|
Change
|
|
2011
|
|
Change
|
|
2010
|
||||||||
Product sales, net
|
$
|
580,527
|
|
|
118
|
%
|
|
$
|
266,518
|
|
|
57
|
%
|
|
$
|
170,006
|
|
Royalties and contract revenues
|
5,452
|
|
|
(5
|
)%
|
|
5,759
|
|
|
53
|
%
|
|
3,775
|
|
|||
Cost of product sales (excluding amortization of acquired developed technologies)
|
78,425
|
|
|
463
|
%
|
|
13,942
|
|
|
3
|
%
|
|
13,559
|
|
|||
Selling, general and administrative
|
223,882
|
|
|
106
|
%
|
|
108,936
|
|
|
58
|
%
|
|
68,996
|
|
|||
Research and development
|
20,477
|
|
|
45
|
%
|
|
14,120
|
|
|
(45
|
)%
|
|
25,612
|
|
|||
Intangible asset amortization
|
65,351
|
|
|
777
|
%
|
|
7,448
|
|
|
(5
|
)%
|
|
7,825
|
|
|||
Interest expense, net
|
16,869
|
|
|
954
|
%
|
|
1,600
|
|
|
(87
|
%)
|
|
12,724
|
|
|||
Foreign currency loss
|
3,620
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
|||
Loss on extinguishment of debt
|
—
|
|
|
N/A(1)
|
|
|
1,247
|
|
|
(90
|
%)
|
|
12,287
|
|
|||
Income tax benefit
|
83,794
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
(1)
|
Comparison to prior period is not meaningful.
|
|
2012
|
|
Change
|
|
2011
|
|
Change
|
|
2010
|
||||||||
Xyrem
|
$
|
378,663
|
|
|
62
|
%
|
|
$
|
233,348
|
|
|
64
|
%
|
|
$
|
142,630
|
|
Erwinaze/Erwinase
|
72,083
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
|||
Prialt
|
26,360
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
|||
Psychiatry:
|
|
|
|
|
|
|
|
|
—
|
|
|||||||
Luvox CR
|
42,419
|
|
|
28
|
%
|
|
33,170
|
|
|
21
|
%
|
|
27,376
|
|
|||
FazaClo LD
|
22,023
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
|||
FazaClo HD
|
12,047
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
|||
Other
|
26,932
|
|
|
N/A(1)
|
|
|
—
|
|
|
N/A(1)
|
|
|
—
|
|
|||
Product sales, net
|
580,527
|
|
|
118
|
%
|
|
266,518
|
|
|
57
|
%
|
|
170,006
|
|
|||
Royalties and contract revenues
|
5,452
|
|
|
(5
|
%)
|
|
5,759
|
|
|
53
|
%
|
|
3,775
|
|
|||
Total revenues
|
$
|
585,979
|
|
|
115
|
%
|
|
$
|
272,277
|
|
|
57
|
%
|
|
$
|
173,781
|
|
(1)
|
Comparison to prior period is not meaningful.
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Personnel expenses
|
$
|
10,432
|
|
|
$
|
10,581
|
|
|
$
|
11,422
|
|
Clinical studies and outside services
|
8,566
|
|
|
2,145
|
|
|
12,320
|
|
|||
Other
|
1,479
|
|
|
1,394
|
|
|
1,870
|
|
|||
Total
|
$
|
20,477
|
|
|
$
|
14,120
|
|
|
$
|
25,612
|
|
|
Year Ended
December 31, 2012
|
||
Product sales, net
|
$
|
20,873
|
|
|
|
||
Loss from discontinued operations before income taxes
|
$
|
(5,787
|
)
|
Income tax expense (1)
|
(2,020
|
)
|
|
Loss from discontinued operations, net of taxes
|
(7,807
|
)
|
|
Gain on sale of discontinued operations (2)
|
35,244
|
|
|
Income from discontinued operations, net of taxes
|
$
|
27,437
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
GAAP income from continuing operations
|
$
|
261,149
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
Intangible asset amortization
|
65,351
|
|
|
7,448
|
|
|
7,825
|
|
|||
Share-based compensation expense
|
23,006
|
|
|
20,704
|
|
|
8,219
|
|
|||
Acquisition accounting inventory fair value step-up
|
16,794
|
|
|
—
|
|
|
—
|
|
|||
Transaction and integration costs
|
18,821
|
|
|
11,245
|
|
|
—
|
|
|||
Restructuring charges
|
2,789
|
|
|
—
|
|
|
—
|
|
|||
Change in fair value of contingent consideration
|
(300
|
)
|
|
—
|
|
|
—
|
|
|||
Loss on extinguishment of debt
|
—
|
|
|
1,247
|
|
|
12,287
|
|
|||
Other non-cash expense (income)
|
2,860
|
|
|
(744
|
)
|
|
(77
|
)
|
|||
Valuation allowance release (1)
|
(104,247
|
)
|
|
—
|
|
|
—
|
|
|||
Income tax adjustments (2)
|
4,171
|
|
|
—
|
|
|
—
|
|
|||
Adjusted net income (3)
|
$
|
290,394
|
|
|
$
|
164,884
|
|
|
$
|
61,032
|
|
|
|
|
|
|
|
||||||
GAAP income from continuing operations per diluted share (4)
|
$
|
4.34
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
Adjusted net income per diluted share (3) (4)
|
$
|
4.82
|
|
|
$
|
3.52
|
|
|
$
|
1.55
|
|
Shares used in computing GAAP income from continuing operations and adjusted net income per diluted share amounts (4)
|
60,195
|
|
|
46,798
|
|
|
39,411
|
|
(1)
|
Reversal of valuation allowance against deferred tax assets, primarily in the United States.
|
(2)
|
Tax related to acquisition restructuring activities partially offset by adjustments to convert the income tax provision to the estimated amount of taxes payable in cash.
|
(3)
|
Adjusted net income and adjusted net income per diluted share as used in this report exclude the impact of discontinued operations.
|
(4)
|
All references to “share” or “shares” in the table above refer to Jazz Pharmaceuticals, Inc.’s common stock with respect to 2010 and 2011, and to Jazz Pharmaceuticals plc’s ordinary shares with respect to the current year periods. GAAP income from continuing operations per diluted share and adjusted net income per diluted share in the comparative prior year periods were not impacted by the Azur Merger since each share of Jazz Pharmaceuticals, Inc. common stock issued and outstanding immediately prior to the effective time of the Azur Merger was canceled and automatically converted into and became the right to receive one ordinary share upon the consummation of the Azur Merger.
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Net cash provided by operating activities
|
$
|
249,752
|
|
|
$
|
151,596
|
|
|
$
|
58,868
|
|
Net cash used in investing activities
|
(395,294
|
)
|
|
(81,232
|
)
|
|
(2,143
|
)
|
|||
Net cash provided by (used in) financing activities
|
448,530
|
|
|
(33,082
|
)
|
|
(27,526
|
)
|
|||
Effect of foreign currency exchange rates on cash and cash equivalents
|
2,132
|
|
|
—
|
|
|
—
|
|
|||
Net increase in cash and cash equivalents
|
$
|
305,120
|
|
|
$
|
37,282
|
|
|
$
|
29,199
|
|
|
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
|
$
|
463,126
|
|
|
$
|
29,688
|
|
|
$
|
89,063
|
|
|
$
|
130,625
|
|
|
$
|
213,750
|
|
Term loan—interest (2)
|
102,316
|
|
|
24,131
|
|
|
42,221
|
|
|
31,013
|
|
|
4,951
|
|
|||||
Purchase obligations (3)
|
72,220
|
|
|
70,100
|
|
|
360
|
|
|
400
|
|
|
1,360
|
|
|||||
Operating lease obligations (4)
|
24,736
|
|
|
6,631
|
|
|
11,593
|
|
|
6,512
|
|
|
—
|
|
|||||
Revolving credit facility (5)
|
2,256
|
|
|
507
|
|
|
1,014
|
|
|
735
|
|
|
—
|
|
|||||
Contingent consideration obligation (6)
|
50,000
|
|
|
—
|
|
|
50,000
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
714,654
|
|
|
$
|
131,057
|
|
|
$
|
194,251
|
|
|
$
|
169,285
|
|
|
$
|
220,061
|
|
(1)
|
This table does not include potential future milestone payment or royalty obligations to third parties under asset purchase, product development and license 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. Potential future milestone payments to third parties under these agreements could be up to an aggregate of $170 million, of which up to $120 million will become due and payable to Elan 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)
|
In June 2012, we entered into a credit agreement that provides for a term loan in an aggregate principal amount of $475.0 million, which matures in June 2018, and a $100.0 million revolving credit facility, which matures in June 2017. In June 2012, we borrowed $475.0 million under the term loan, and we repaid principal of
$11.9 million
in 2012. The interest rate was
5.25%
at December 31, 2012, which we used to estimate interest owed on the term loan until the final maturity date.
|
(3)
|
Consists primarily of non-cancelable commitments to third party manufacturers.
|
(4)
|
Includes the minimum lease payments for our office buildings and automobile lease payments for our sales force.
|
(5)
|
The revolving credit facility described in note (2) has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.50% per annum based upon our secured leverage ratio. In the table above, we used a rate of 0.50% and assumed undrawn amounts of $100.0 million to estimate commitment fees owed. No amount was borrowed under the revolving credit facility as of December 31, 2012.
|
(6)
|
This amount represents a contingent payment of $50.0 million that we agreed to make if Erwinaze achieves U.S. net sales of $124.5 million or greater in 2013. The amount set forth in the table has not been probability adjusted or
|
|
Rebates
Payable
|
|
Sales
Returns
Reserve
|
|
Chargebacks
|
|
Total
|
||||||||
Balance at December 31, 2009
|
$
|
2,270
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,270
|
|
Provision
|
11,096
|
|
|
3,921
|
|
|
233
|
|
|
15,250
|
|
||||
Payments/credits
|
(6,746
|
)
|
|
(382
|
)
|
|
(221
|
)
|
|
(7,349
|
)
|
||||
Balance at December 31, 2010
|
6,620
|
|
|
3,539
|
|
|
12
|
|
|
10,171
|
|
||||
Provision
|
21,742
|
|
|
2,250
|
|
|
451
|
|
|
24,443
|
|
||||
Payments/credits
|
(17,585
|
)
|
|
(1,487
|
)
|
|
(443
|
)
|
|
(19,515
|
)
|
||||
Balance at December 31, 2011
|
10,777
|
|
|
4,302
|
|
|
20
|
|
|
15,099
|
|
||||
Additions relating to acquisitions
|
8,809
|
|
|
18,833
|
|
|
—
|
|
|
27,642
|
|
||||
Provision
|
52,603
|
|
|
9,733
|
|
|
13,072
|
|
|
75,408
|
|
||||
Payments/credits
|
(46,942
|
)
|
|
(6,483
|
)
|
|
(10,556
|
)
|
|
(63,981
|
)
|
||||
Balance at December 31, 2012 (1)
|
$
|
25,247
|
|
|
$
|
26,385
|
|
|
$
|
2,536
|
|
|
$
|
54,168
|
|
•
|
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.
|
|
Year Ended December 31,
|
|||||||
|
2012
|
|
2011
|
|
2010
|
|||
Volatility
|
64
|
%
|
|
72
|
%
|
|
85
|
%
|
Expected term (years)
|
4.6
|
|
|
5.2
|
|
|
6.0
|
|
Range of risk-free rates
|
0.5-1.1%
|
|
|
0.0-2.7%
|
|
|
1.5-3.1%
|
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 8.
|
Financial Statements and Supplementary Data
|
|
Page
|
Jazz Pharmaceuticals plc
|
|
Reports of Independent Registered Public Accounting Firms
|
F-1
|
Consolidated Balance Sheets
|
F-3
|
Consolidated Statements of Income
|
F-4
|
Consolidated Statements of Comprehensive Income
|
F-5
|
Consolidated Statements of Shareholders’ Equity
|
F-6
|
Consolidated Statements of Cash Flows
|
F-8
|
Notes to Consolidated Financial Statements
|
F-10
|
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, 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, 2012 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, 2012, 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
|
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
|
|
Asset Purchase Agreement, dated as of September 5, 2012, by and among Jazz Pharmaceuticals plc, Jazz Pharmaceuticals International II Limited, Meda Pharmaceuticals Inc. and Meda Pharma, Sàrl (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 October 15, 2012).
|
3.1
|
|
Memorandum and Articles of Association of Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
4.1
|
|
Reference is made to Exhibit 3.1.
|
4.2A
|
|
Third Amended and Restated Investor Rights Agreement, made effective as of June 6, 2007, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3 in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2007, as filed with the SEC on August 10, 2007).
|
4.2B
|
|
Waiver and Amendment Agreement, dated as of March 12, 2008, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3B in Jazz Pharmaceuticals, Inc.’s annual report on Form 10-K (File No. 001-33500), for the period ended December 31, 2007, as filed with the SEC on March 31, 2008).
|
Exhibit
Number |
|
Description of Document
|
4.2C
|
|
Waiver and Amendment Agreement, dated as of May 7, 2008, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3C in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on May 9, 2008).
|
4.2D
|
|
Waiver and Amendment Agreement, dated as of July 6, 2009, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3D in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2009, as filed with the SEC on August 14, 2009).
|
4.2E
|
|
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 4.2E 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).
|
4.3
|
|
Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 4.4 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).
|
4.4
|
|
Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Registered Direct Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 4.5 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).
|
4.5
|
|
Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. on July 7, 2009 (incorporated herein by reference to Exhibit 4.6 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).
|
4.6A
|
|
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).
|
4.6B
|
|
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).
|
4.7
|
|
Registration Rights Agreement made as of January 13, 2012, by and among Jazz Pharmaceuticals plc and certain shareholders named therein (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
10.1†
|
|
Xyrem Manufacturing Services and Supply Agreement, dated as of March 13, 2007, by and between Jazz Pharmaceuticals, Inc. and Patheon Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.50 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on May 31, 2007).
|
10.2†
|
|
Quality Agreement, dated as of March 13, 2007, by and between Jazz Pharmaceuticals, Inc. and Patheon Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.51 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).
|
10.3†
|
|
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).
|
10.4
|
|
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).
|
10.5
|
|
Escrow Agreement made and entered into as of January 18, 2012, by and among Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., Seamus Mulligan, solely in his capacity as Indemnitors’ Representative, and Deutsche Bank National Trust Association, as escrow agent (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
Exhibit
Number |
|
Description of Document
|
10.6†
|
|
Royalty Bearing License Agreement and Supply Agreement Re Erwinia-Derived Asparaginase, dated July 22, 2005, between the 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), as filed with the SEC on August 9, 2012).
|
10.7
|
|
Credit Agreement, dated as of June 12, 2012, by and among Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., the Lenders and Barclays Bank PLC, as Administrative Agent, Collateral 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 12, 2012).
|
10.8
|
|
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).
|
10.9
|
|
Lease Agreement, dated October 20, 2008, between Seamus Mulligan, as lessor, and Jazz Pharmaceuticals plc, as lessee (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-4 (File No. 333-177528), as filed with the SEC on October 26, 2011).
|
10.10
|
|
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).
|
10.11
|
|
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).
|
10.12
|
|
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), as filed with the SEC on August 7, 2012).
|
10.13
|
|
Surrender of Lease of 45 Fitzwilliam Square Dublin 2, dated November 9, 2012, between Seamus Mulligan, as lessor, and Jazz Pharmaceuticals plc, as lessee.
|
10.14+
|
|
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).
|
10.15+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Kathryn Falberg (incorporated herein by reference to Exhibit 10.92 in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on December 3, 2009).
|
10.16+
|
|
Employment Agreement by and between Seamus Mulligan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s registration statement on Form S-4 (File No. 333-177528), as filed with the SEC on October 26, 2011).
|
10.17+
|
|
Noncompetition Agreement by and between Seamus Mulligan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s registration statement on Form S-4 (File No. 333-177528), as filed with the SEC on October 26, 2011).
|
10.18+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Jeffrey Tobias, M.D. (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on November 8, 2011).
|
10.19+
|
|
Separation Agreement, dated January 18, 2012, by and between Jazz Pharmaceuticals plc and Carol Gamble (incorporated herein by reference to Exhibit 10.27 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).
|
10.20+
|
|
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), as filed with the SEC on May 8, 2012).
|
10.21+
|
|
Amendment to Employment Agreement by and between Jazz Pharmaceuticals plc and Seamus Mulligan (incorporated herein by reference to Exhibit 10.20 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on May 8, 2012).
|
10.22+
|
|
Employment Agreement by and between Fintan Keegan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 7, 2012).
|
Exhibit
Number |
|
Description of Document
|
10.23+
|
|
Amendment to Employment Agreement by and between Fintan Keegan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 7, 2012).
|
10.24+
|
|
Noncompetition Agreement by and between Fintan Keegan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 7, 2012).
|
10.25A
|
|
Civil Settlement Agreement, dated July 13, 2007, among the United States of America acting through the entities named therein, Jazz Pharmaceuticals, Inc. and Orphan Medical, Inc. (incorporated herein by reference to Exhibit 10.57A in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
|
10.25B
|
|
Non-Prosecution Agreement, dated July 13, 2007, between the United States Attorney’s Office for the Eastern District of New York and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.57B in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
|
10.25C
|
|
Plea Agreement, dated July 13, 2007, between the United States Attorney for the Eastern District of New York and Orphan Medical, Inc. (incorporated herein by reference to Exhibit 10.57C in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
|
10.25D
|
|
Corporate Integrity Agreement, dated July 13, 2007, between the Office of Inspector General of the Department of Health and Human Services and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.57D in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
|
10.26A+
|
|
Jazz Pharmaceuticals plc 2003 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.5 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
10.26B+
|
|
Form of Option Exercise and Stock Purchase Agreement and Forms of Grant Notices under the Jazz Pharmaceuticals, Inc. 2003 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.22 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on May 17, 2007).
|
10.26C+
|
|
Form of Letter, amending outstanding options granted under the Jazz Pharmaceuticals, Inc. 2003 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.60 in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2007, as filed with the SEC on August 10, 2007).
|
10.27A+
|
|
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).
|
10.27B+
|
|
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).
|
10.27C+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan.
|
10.27D+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (Irish) under Jazz Pharmaceuticals plc 2007 Equity Incentive Plan.
|
10.27E+
|
|
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.
|
10.27F+
|
|
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.
|
10.28A+
|
|
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).
|
10.28B+
|
|
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).
|
10.28C+
|
|
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), as filed with the SEC on August 7, 2012).
|
Exhibit
Number |
|
Description of Document
|
10.28D+
|
|
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), as filed with the SEC on August 7, 2012).
|
10.28E+
|
|
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.
|
10.28F+
|
|
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), as filed with the SEC on August 7, 2012).
|
10.28G+
|
|
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), as filed with the SEC on August 7, 2012).
|
10.28H+
|
|
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.
|
10.29+
|
|
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).
|
10.30A+
|
|
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).
|
10.30B+
|
|
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.
|
10.31A+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan, as amended and restated.
|
10.31B+
|
|
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 10.4C 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 August 7, 2012).
|
10.32A+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan, (incorporated herein by reference to Exhibit 10.33 in the annual report on Form 10-K/A (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 April 27, 2012).
|
10.32B+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates.
|
10.32C+
|
|
Jazz Pharmaceuticals Cash Bonus Plan for International Affiliates (2013).
|
10.33+
|
|
Jazz Pharmaceuticals plc Amended and Restated Executive Change in Control and Severance Benefit Plan (incorporated herein by reference to Exhibit 10.34 in the annual report on Form 10-K/A (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 April 27, 2012).
|
10.34+
|
|
Jazz Pharmaceuticals plc 2012 Non-Employee Director Compensation Arrangements (incorporated herein by reference to Exhibit 10.32 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).
|
10.35+
|
|
Jazz Pharmaceuticals plc 2012 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 June 30, 2012, as filed with the SEC on August 7, 2012).
|
21.1
|
|
Subsidiaries of Jazz Pharmaceuticals plc.
|
23.1
|
|
Consent of KPMG, Independent Registered Public Accounting Firm.
|
23.2
|
|
Consent of Ernst & Young LLP, 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
|
Exhibit
Number |
|
Description of 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.
|
++
|
Pursuant to applicable securities laws and regulations, the Registrant is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as the Registrant has made a good faith attempt to comply with the submission requirements and promptly amends the interactive data files after becoming aware that the interactive data files fails to comply with the submission requirements. These interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under these sections.
|
Date: February 26, 2013
|
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/ K
ATHRYN
E. F
ALBERG
|
|
Kathryn E. Falberg
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 26, 2013
|
Bruce C. Cozadd
|
|
|
||
/
s
/ K
ATHRYN
E. F
ALBERG
|
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|
|
February 26, 2013
|
Kathryn E. Falberg
|
|
|
||
/
s
/ K
AREN
J. W
ILSON
|
|
Senior Vice President, Finance
(Principal Accounting Officer)
|
|
February 26, 2013
|
Karen J. Wilson
|
|
|
||
/s/ P
AUL
L. B
ERNS
|
|
Director
|
|
February 26, 2013
|
Paul L. Berns
|
|
|
|
|
/
s
/ P
ATRICK
G. E
NRIGHT
|
|
Director
|
|
February 26, 2013
|
Patrick G. Enright
|
|
|
|
|
/
s
/ J
AMES
C. M
OMTAZEE
|
|
Director
|
|
February 26, 2013
|
James C. Momtazee
|
|
|
|
|
/
s
/ S
EAMUS
C. M
ULLIGAN
|
|
Director
|
|
February 26, 2013
|
Seamus C. Mulligan
|
|
|
|
|
/
s
/ K
ENNETH
W. O’
KEEFE
|
|
Director
|
|
February 26, 2013
|
Kenneth W. O’Keefe
|
|
|
|
|
/
s
/ C
ATHERINE
A. S
OHN
|
|
Director
|
|
February 26, 2013
|
Catherine A. Sohn
|
|
|
|
|
/
s
/ R
ICK
E W
INNINGHAM
|
|
Director
|
|
February 26, 2013
|
Rick E Winningham
|
|
|
|
|
|
December 31,
|
||||||
|
2012
|
|
2011
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
387,196
|
|
|
$
|
82,076
|
|
Marketable securities
|
—
|
|
|
75,822
|
|
||
Accounts receivable, net of allowances of $3,779 and $366 at December 31, 2012 and 2011, respectively
|
75,480
|
|
|
34,374
|
|
||
Inventories
|
26,525
|
|
|
3,909
|
|
||
Prepaid expenses
|
7,445
|
|
|
1,690
|
|
||
Deferred tax assets, net
|
35,813
|
|
|
—
|
|
||
Other current assets
|
19,113
|
|
|
1,260
|
|
||
Total current assets
|
551,572
|
|
|
199,131
|
|
||
Property and equipment, net
|
7,281
|
|
|
1,557
|
|
||
Intangible assets, net
|
869,952
|
|
|
14,585
|
|
||
Goodwill
|
442,600
|
|
|
38,213
|
|
||
Deferred tax assets, net, non-current
|
74,850
|
|
|
—
|
|
||
Deferred financing costs
|
16,576
|
|
|
—
|
|
||
Other long-term assets
|
3,662
|
|
|
87
|
|
||
Total assets
|
$
|
1,966,493
|
|
|
$
|
253,573
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
15,887
|
|
|
$
|
5,129
|
|
Accrued liabilities
|
104,666
|
|
|
34,783
|
|
||
Current portion of long-term debt
|
29,688
|
|
|
—
|
|
||
Income taxes payable
|
39,884
|
|
|
—
|
|
||
Deferred tax liability, net
|
275
|
|
|
—
|
|
||
Purchased product rights liability
|
—
|
|
|
4,500
|
|
||
Liability under government settlement
|
—
|
|
|
7,320
|
|
||
Deferred revenue
|
1,138
|
|
|
1,138
|
|
||
Total current liabilities
|
191,538
|
|
|
52,870
|
|
||
Deferred revenue, non-current
|
6,776
|
|
|
7,915
|
|
||
Long-term debt, less current portion
|
427,073
|
|
|
—
|
|
||
Contingent consideration
|
34,800
|
|
|
—
|
|
||
Deferred tax liability, net, non-current
|
178,393
|
|
|
—
|
|
||
Other non-current liabilities
|
6,621
|
|
|
—
|
|
||
Commitments and contingencies (Note 11)
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value per share; zero and 20,000 shares authorized; no shares issued and outstanding at December 31, 2012 and 2011, respectively
|
—
|
|
|
—
|
|
||
Ordinary shares, nominal value $0.0001 per share; 300,000 and 150,000 shares authorized; 58,014 and 42,468 shares issued and outstanding at December 31, 2012 and 2011, respectively
|
6
|
|
|
4
|
|
||
Non-voting euro deferred shares, €0.01 par value per share; 4,000 and no shares authorized, issued and outstanding at December 31, 2012 and 2011, respectively
|
55
|
|
|
—
|
|
||
Capital redemption reserve
|
471
|
|
|
—
|
|
||
Additional paid-in capital
|
1,151,010
|
|
|
542,697
|
|
||
Accumulated other comprehensive income (loss)
|
31,046
|
|
|
(31
|
)
|
||
Accumulated deficit
|
(61,296
|
)
|
|
(349,882
|
)
|
||
Total shareholders’ equity
|
1,121,292
|
|
|
192,788
|
|
||
Total liabilities and shareholders’ equity
|
$
|
1,966,493
|
|
|
$
|
253,573
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
580,527
|
|
|
$
|
266,518
|
|
|
$
|
170,006
|
|
Royalties and contract revenues
|
5,452
|
|
|
5,759
|
|
|
3,775
|
|
|||
Total revenues
|
585,979
|
|
|
272,277
|
|
|
173,781
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of product sales (excluding amortization of acquired developed technologies)
|
78,425
|
|
|
13,942
|
|
|
13,559
|
|
|||
Selling, general and administrative
|
223,882
|
|
|
108,936
|
|
|
68,996
|
|
|||
Research and development
|
20,477
|
|
|
14,120
|
|
|
25,612
|
|
|||
Intangible asset amortization
|
65,351
|
|
|
7,448
|
|
|
7,825
|
|
|||
Total operating expenses
|
388,135
|
|
|
144,446
|
|
|
115,992
|
|
|||
Income from operations
|
197,844
|
|
|
127,831
|
|
|
57,789
|
|
|||
Interest expense, net (including $570 for the year ended December 31, 2010 pertaining to a related party)
|
(16,869
|
)
|
|
(1,600
|
)
|
|
(12,724
|
)
|
|||
Foreign currency loss
|
(3,620
|
)
|
|
—
|
|
|
—
|
|
|||
Loss on extinguishment of debt (including $701 for the year ended December 31, 2010 pertaining to a related party)
|
—
|
|
|
(1,247
|
)
|
|
(12,287
|
)
|
|||
Income from continuing operations before income tax benefit
|
177,355
|
|
|
124,984
|
|
|
32,778
|
|
|||
Income tax benefit
|
(83,794
|
)
|
|
—
|
|
|
—
|
|
|||
Income from continuing operations
|
261,149
|
|
|
124,984
|
|
|
32,778
|
|
|||
Income from discontinued operations, net of taxes
|
27,437
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
$
|
288,586
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
Basic income per ordinary share:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
4.61
|
|
|
$
|
3.01
|
|
|
$
|
0.90
|
|
Income from discontinued operations
|
0.48
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
$
|
5.09
|
|
|
$
|
3.01
|
|
|
$
|
0.90
|
|
Diluted income per ordinary share:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
4.34
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
Income from discontinued operations
|
0.45
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
$
|
4.79
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
Weighted-average ordinary shares used in per share computations:
|
|
|
|
|
|
||||||
Basic
|
56,643
|
|
|
41,499
|
|
|
36,343
|
|
|||
Diluted
|
60,195
|
|
|
46,798
|
|
|
39,411
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Net income
|
$
|
288,586
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Foreign currency translation adjustments
|
31,046
|
|
|
—
|
|
|
—
|
|
|||
Available-for-sale securities:
|
|
|
|
|
|
||||||
Net unrealized gain (loss) on available-for-sale securities, net of income taxes
|
8
|
|
|
(31
|
)
|
|
—
|
|
|||
Reclassification adjustments for gains included in earnings, net of income taxes
|
23
|
|
|
—
|
|
|
—
|
|
|||
Other comprehensive income (loss)
|
31,077
|
|
|
(31
|
)
|
|
—
|
|
|||
Total comprehensive income
|
$
|
319,663
|
|
|
$
|
124,953
|
|
|
$
|
32,778
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income
|
|
Accumulated
Deficit
|
|
Total
Shareholders’
Equity
|
|||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
||||||||||||||||||||||||
Balance at December 31, 2009
|
31,255
|
|
|
$
|
3
|
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
434,811
|
|
|
$
|
—
|
|
|
$
|
(507,644
|
)
|
|
$
|
(72,830
|
)
|
Stock issuable under directors deferred compensation plan
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
198
|
|
|
—
|
|
|
—
|
|
|
198
|
|
||||||
Issuance of common stock in conjunction with exercise of stock options
|
955
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,682
|
|
|
—
|
|
|
—
|
|
|
3,682
|
|
||||||
Issuance of common stock in conjunction with vesting of restricted stock units
|
13
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock under employee stock purchase plan
|
520
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
529
|
|
|
—
|
|
|
—
|
|
|
529
|
|
||||||
Issuance of common stock in conjunction with offering, net of issuance costs
|
7,000
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
56,816
|
|
|
—
|
|
|
—
|
|
|
56,817
|
|
||||||
Issuance of common stock in conjunction with exercise of warrants
|
216
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,380
|
|
|
—
|
|
|
—
|
|
|
1,380
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,997
|
|
|
—
|
|
|
—
|
|
|
7,997
|
|
||||||
Net income and comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32,778
|
|
|
32,778
|
|
||||||
Balance at December 31, 2010
|
39,959
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
505,413
|
|
|
—
|
|
|
(474,866
|
)
|
|
30,551
|
|
||||||
Stock issued/issuable under directors deferred compensation plan
|
13
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
368
|
|
|
—
|
|
|
—
|
|
|
368
|
|
||||||
Issuance of common stock in conjunction with exercise of stock options
|
1,400
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
12,214
|
|
|
—
|
|
|
—
|
|
|
12,214
|
|
||||||
Issuance of common stock in conjunction with vesting of restricted stock units
|
13
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock under employee stock purchase plan
|
359
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,546
|
|
|
—
|
|
|
—
|
|
|
1,546
|
|
||||||
Issuance of common stock in conjunction with exercise of warrants
|
724
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,659
|
|
|
—
|
|
|
—
|
|
|
2,659
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
20,497
|
|
|
—
|
|
|
—
|
|
|
20,497
|
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(31
|
)
|
|
—
|
|
|
(31
|
)
|
||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
124,984
|
|
|
124,984
|
|
||||||
Balance at December 31, 2011
|
42,468
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
542,697
|
|
|
(31
|
)
|
|
(349,882
|
)
|
|
192,788
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income
|
|
Accumulated
Deficit
|
|
Total
Shareholders’
Equity
|
||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||
Balance at December 31, 2011
|
42,468
|
|
|
$
|
4
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
542,697
|
|
|
$
|
(31
|
)
|
|
$
|
(349,882
|
)
|
|
$
|
192,788
|
|
Merger with Azur Pharma
|
12,360
|
|
|
2
|
|
|
4,000
|
|
|
55
|
|
|
471
|
|
|
575,936
|
|
|
—
|
|
|
—
|
|
|
576,464
|
|
|||||||
Issuance costs related to Azur Merger
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(241
|
)
|
|
—
|
|
|
—
|
|
|
(241
|
)
|
|||||||
Shares issued under directors deferred compensation plan
|
45
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Issuance of ordinary shares in conjunction with exercise of share options
|
1,951
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,212
|
|
|
—
|
|
|
—
|
|
|
14,212
|
|
|||||||
Issuance of ordinary shares under employee stock purchase plan
|
151
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,707
|
|
|
—
|
|
|
—
|
|
|
3,707
|
|
|||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(25,299
|
)
|
|
—
|
|
|
—
|
|
|
(25,299
|
)
|
|||||||
Issuance of ordinary shares in conjunction with exercise of warrants
|
1,039
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,084
|
|
|
—
|
|
|
—
|
|
|
7,084
|
|
|||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
23,129
|
|
|
—
|
|
|
—
|
|
|
23,129
|
|
|||||||
Excess tax benefits from employee share options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,785
|
|
|
—
|
|
|
—
|
|
|
9,785
|
|
|||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31,077
|
|
|
—
|
|
|
31,077
|
|
|||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
288,586
|
|
|
288,586
|
|
|||||||
Balance at December 31, 2012
|
58,014
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,151,010
|
|
|
$
|
31,046
|
|
|
$
|
(61,296
|
)
|
|
$
|
1,121,292
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net income
|
$
|
288,586
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Amortization of intangible assets
|
72,922
|
|
|
7,448
|
|
|
7,825
|
|
|||
Depreciation
|
1,307
|
|
|
379
|
|
|
886
|
|
|||
Loss on disposal of property and equipment
|
163
|
|
|
33
|
|
|
279
|
|
|||
Share-based compensation
|
23,006
|
|
|
20,704
|
|
|
8,219
|
|
|||
Excess tax benefit from share-based compensation
|
(9,785
|
)
|
|
—
|
|
|
—
|
|
|||
Acquisition accounting inventory fair value step-up
|
19,939
|
|
|
—
|
|
|
—
|
|
|||
Change in fair value of contingent consideration
|
(300
|
)
|
|
—
|
|
|
—
|
|
|||
Deferred income taxes
|
(113,862
|
)
|
|
—
|
|
|
—
|
|
|||
Gain on sale of business
|
(35,244
|
)
|
|
—
|
|
|
—
|
|
|||
Provision for losses on accounts receivable and inventory
|
4,654
|
|
|
59
|
|
|
(105
|
)
|
|||
Other non-cash transactions
|
3,523
|
|
|
394
|
|
|
2,406
|
|
|||
Loss on extinguishment of debt
|
—
|
|
|
1,247
|
|
|
12,287
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(4,724
|
)
|
|
(12,293
|
)
|
|
(9,768
|
)
|
|||
Inventories
|
1,697
|
|
|
1,239
|
|
|
(1,539
|
)
|
|||
Prepaid expenses and other current assets
|
(13,091
|
)
|
|
(934
|
)
|
|
426
|
|
|||
Other long-term assets
|
(3,491
|
)
|
|
186
|
|
|
—
|
|
|||
Accounts payable
|
(7,286
|
)
|
|
2,080
|
|
|
891
|
|
|||
Accrued liabilities
|
(1,643
|
)
|
|
11,211
|
|
|
9,276
|
|
|||
Income taxes payable
|
29,555
|
|
|
—
|
|
|
—
|
|
|||
Deferred revenue
|
(1,205
|
)
|
|
(1,273
|
)
|
|
(2,540
|
)
|
|||
Other non-current liabilities
|
2,351
|
|
|
(82
|
)
|
|
53
|
|
|||
Liability under government settlement
|
(7,320
|
)
|
|
(3,786
|
)
|
|
(2,506
|
)
|
|||
Net cash provided by operating activities
|
249,752
|
|
|
151,596
|
|
|
58,868
|
|
|||
Investing activities
|
|
|
|
|
|
||||||
Acquisitions, net of cash acquired
|
(542,531
|
)
|
|
—
|
|
|
—
|
|
|||
Purchases of marketable securities
|
(37,443
|
)
|
|
(79,886
|
)
|
|
—
|
|
|||
Net proceeds from sale of business
|
93,922
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from sale of marketable securities
|
81,246
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from maturities of marketable securities
|
31,988
|
|
|
4,033
|
|
|
—
|
|
|||
Purchases of property and equipment
|
(5,976
|
)
|
|
(1,279
|
)
|
|
(731
|
)
|
|||
Purchase of product rights
|
(16,500
|
)
|
|
(4,500
|
)
|
|
(4,000
|
)
|
|||
Decrease in restricted cash
|
—
|
|
|
400
|
|
|
2,588
|
|
|||
Net cash used in investing activities
|
(395,294
|
)
|
|
(81,232
|
)
|
|
(2,143
|
)
|
|||
Financing activities
|
|
|
|
|
|
||||||
Net proceeds from issuance of debt
|
450,916
|
|
|
—
|
|
|
48,427
|
|
|||
Proceeds from employee share purchases, exercise of share options and warrants
|
25,003
|
|
|
16,419
|
|
|
5,591
|
|
|||
Payment of employee withholding taxes upon exercise of share-based awards
|
(25,299
|
)
|
|
—
|
|
|
—
|
|
|||
Excess tax benefit from share-based compensation
|
9,785
|
|
|
—
|
|
|
—
|
|
|||
Repayment of long-term debt (including $6,816 for the year ended December 31, 2010 paid to a related party)
|
(11,875
|
)
|
|
(41,668
|
)
|
|
(127,828
|
)
|
|||
Payments of debt extinguishment costs (including $484 for the year ended December 31, 2010 paid to a related party)
|
—
|
|
|
(483
|
)
|
|
(8,484
|
)
|
|||
Proceeds from offerings of common stock, net of issuance costs
|
—
|
|
|
—
|
|
|
56,817
|
|
|||
Net repayments under revolving credit facility
|
—
|
|
|
(7,350
|
)
|
|
(2,049
|
)
|
|||
Net cash provided by (used in) financing activities
|
448,530
|
|
|
(33,082
|
)
|
|
(27,526
|
)
|
|||
Effect of exchange rates on cash and cash equivalents
|
2,132
|
|
|
—
|
|
|
—
|
|
|||
Net increase in cash and cash equivalents
|
305,120
|
|
|
37,282
|
|
|
29,199
|
|
|||
Cash and cash equivalents, at beginning of period
|
82,076
|
|
|
44,794
|
|
|
15,595
|
|
|||
Cash and cash equivalents, at end of period
|
$
|
387,196
|
|
|
$
|
82,076
|
|
|
$
|
44,794
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest (including $461 for the year ended December 31, 2010 paid to a related party)
|
$
|
14,192
|
|
|
$
|
1,621
|
|
|
$
|
10,234
|
|
Cash paid for income taxes
|
$
|
9,143
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Non-cash investing activities:
|
|
|
|
|
|
||||||
Acquisition consideration for Azur Merger
|
$
|
576,464
|
|
|
$
|
—
|
|
|
$
|
—
|
|
•
|
Growing sales of the existing products in our portfolio, including by identifying new growth opportunities;
|
•
|
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
|
•
|
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
261,149
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
Income from discontinued operations
|
27,437
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
$
|
288,586
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
Denominator:
|
|
|
|
|
|
||||||
Weighted-average ordinary shares - basic
|
56,643
|
|
|
41,499
|
|
|
36,343
|
|
|||
Dilutive effect of employee equity incentive and purchase plans
|
1,536
|
|
|
2,715
|
|
|
1,720
|
|
|||
Dilutive effect of warrants
|
2,016
|
|
|
2,584
|
|
|
1,348
|
|
|||
Weighted-average ordinary shares - diluted
|
60,195
|
|
|
46,798
|
|
|
39,411
|
|
|||
|
|
|
|
|
|
||||||
Basic income per ordinary share:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
4.61
|
|
|
$
|
3.01
|
|
|
$
|
0.90
|
|
Income from discontinued operations
|
0.48
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
$
|
5.09
|
|
|
$
|
3.01
|
|
|
$
|
0.90
|
|
Diluted income per ordinary share:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
4.34
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
Income from discontinued operations
|
0.45
|
|
|
—
|
|
|
—
|
|
|||
Net income
|
$
|
4.79
|
|
|
$
|
2.67
|
|
|
$
|
0.83
|
|
|
Year Ended December 31,
|
|||||||
|
2012
|
|
2011
|
|
2010
|
|||
Options to purchase ordinary shares and RSUs
|
1,506
|
|
|
1,038
|
|
|
3,211
|
|
Cash and cash equivalents
|
$
|
81,751
|
|
Accounts receivable (1)
|
12,975
|
|
|
Inventories
|
15,344
|
|
|
Property and equipment
|
370
|
|
|
Intangible assets
|
325,000
|
|
|
Goodwill
|
201,524
|
|
|
Other assets
|
4,862
|
|
|
Accounts payable and accrued liabilities
|
(52,148
|
)
|
|
Purchased product rights liability
|
(11,899
|
)
|
|
Above market lease obligation
|
(1,315
|
)
|
|
Total acquisition consideration
|
$
|
576,464
|
|
(1)
|
The estimated fair value of trade receivables acquired was
$13.0 million
. The gross contractual amount of trade receivables was
$13.8 million
and was recorded net of allowances for wholesaler chargebacks related to government rebate programs and cash discounts for prompt payment. We expect that
$0.8 million
of the gross contractual amount of trade receivables will be uncollectible.
|
Acquired developed technologies:
|
|
||
Prialt
®
|
$
|
231,000
|
|
Women’s health products
|
49,000
|
|
|
FazaClo HD
®
|
18,000
|
|
|
FazaClo LD
®
|
18,000
|
|
|
Other central nervous system products
|
7,000
|
|
|
Total acquired developed technologies
|
323,000
|
|
|
In-process research and development:
|
|
||
Versacloz
TM
(clozapine, USP)
|
2,000
|
|
|
Total intangible assets
|
$
|
325,000
|
|
Base payment
|
$
|
650,000
|
|
Cash acquired
|
54,117
|
|
|
Working capital and other adjustments
|
(25,719
|
)
|
|
Upfront payment in accordance with agreement
|
678,398
|
|
|
Estimated fair value of contingent consideration
|
35,100
|
|
|
Total acquisition consideration
|
$
|
713,498
|
|
Cash and cash equivalents
|
$
|
54,117
|
|
Accounts receivable (1)
|
23,354
|
|
|
Inventories
|
36,360
|
|
|
Prepaid assets
|
6,212
|
|
|
Property and equipment
|
764
|
|
|
Intangible assets
|
616,970
|
|
|
Goodwill
|
206,452
|
|
|
Other assets
|
436
|
|
|
Accounts payable and accrued liabilities
|
(44,502
|
)
|
|
Deferred tax liability
|
(186,591
|
)
|
|
Other liabilities
|
(74
|
)
|
|
Total acquisition consideration
|
$
|
713,498
|
|
(1)
|
The estimated fair value of trade receivables acquired was
$23.4 million
. The gross contractual amount of trade receivables was
$25.1 million
and was recorded net of allowances for wholesaler chargebacks related to government rebate programs, cash discounts for prompt payment and doubtful accounts. We expect that
$1.7 million
of the gross contractual amount of trade receivables will be uncollectible.
|
Acquired developed technologies:
|
|
||
Erwinaze
®
/Erwinase
®
|
$
|
472,000
|
|
Caphosol
®
and ProstaScint
®
|
50,000
|
|
|
Collatamp
®
|
21,000
|
|
|
Other pharmaceutical products
|
41,470
|
|
|
Total acquired developed technologies
|
584,470
|
|
|
In-process research and development:
|
|
||
Asparec
®
|
30,000
|
|
|
Leukotac
®
|
2,500
|
|
|
Total in-process research and development
|
32,500
|
|
|
Total intangible assets
|
$
|
616,970
|
|
•
|
An increase in amortization expense of
$6.3 million
and
$68.1 million
in 2012 and 2011, respectively, related to the fair value of acquired identifiable intangible assets.
|
•
|
The exclusion of transaction-related expenses of
$33.1 million
and
$14.2 million
in 2012 and 2011, respectively.
|
•
|
A decrease in interest expense of
$2.5 million
in 2012 and an increase of
$17.3 million
in 2011, incurred on additional borrowings made to fund the EUSA Acquisition, as if the borrowings had occurred on January 1, 2011, offset by the elimination of actual interest expense incurred by EUSA Pharma during the periods presented.
|
•
|
The exclusion of other non-recurring expenses of
$69.7 million
in 2012 and the inclusion of
$24.1 million
in 2011 primarily related to the fair value step-up to acquired inventory, share-based compensation incurred from the acceleration of stock option vesting upon closing of the Azur Merger and the EUSA Acquisition, a share-based liability granted to certain former Azur Pharma shareholders and integration-related expenses.
|
|
|
Year Ended December 31,
|
||||||
|
|
2012
|
|
2011
|
||||
Revenues
|
|
$
|
668,924
|
|
|
$
|
429,778
|
|
Net income
|
|
$
|
343,897
|
|
|
$
|
20,203
|
|
Net income per ordinary share - basic
|
|
$
|
6.01
|
|
|
$
|
0.38
|
|
Net income per ordinary share - diluted
|
|
$
|
5.66
|
|
|
$
|
0.34
|
|
|
December 31, 2012
|
||||||||||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Marketable
Securities
|
||||||||||||
Cash
|
$
|
343,548
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
343,548
|
|
|
$
|
343,548
|
|
|
$
|
—
|
|
Money market funds
|
43,648
|
|
|
—
|
|
|
—
|
|
|
43,648
|
|
|
43,648
|
|
|
—
|
|
||||||
Totals
|
$
|
387,196
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
387,196
|
|
|
$
|
387,196
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
December 31, 2011
|
||||||||||||||||||||||
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Marketable
Securities
|
||||||||||||
Cash
|
$
|
33,307
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
33,307
|
|
|
$
|
33,307
|
|
|
$
|
—
|
|
Money market funds
|
48,518
|
|
|
—
|
|
|
—
|
|
|
48,518
|
|
|
48,518
|
|
|
—
|
|
||||||
Certificates of deposit
|
7,300
|
|
|
—
|
|
|
(6
|
)
|
|
7,294
|
|
|
—
|
|
|
7,294
|
|
||||||
Corporate debt securities
|
50,371
|
|
|
7
|
|
|
(34
|
)
|
|
50,344
|
|
|
—
|
|
|
50,344
|
|
||||||
Obligations of U.S. government agencies
|
18,433
|
|
|
3
|
|
|
(1
|
)
|
|
18,435
|
|
|
251
|
|
|
18,184
|
|
||||||
Totals
|
$
|
157,929
|
|
|
$
|
10
|
|
|
$
|
(41
|
)
|
|
$
|
157,898
|
|
|
$
|
82,076
|
|
|
$
|
75,822
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||||||||||
|
|
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
Estimated
Fair Value
|
|
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Total
Estimated
Fair Value
|
||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Money market funds
|
|
$
|
43,648
|
|
|
$
|
—
|
|
|
$
|
43,648
|
|
|
$
|
48,518
|
|
|
$
|
—
|
|
|
$
|
48,518
|
|
Certificates of deposit
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,294
|
|
|
7,294
|
|
||||||
Corporate debt securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
50,344
|
|
|
50,344
|
|
||||||
Obligations of U.S. government agencies
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
18,435
|
|
|
18,435
|
|
||||||
Total available-for-sale securities at fair value
|
|
$
|
43,648
|
|
|
$
|
—
|
|
|
$
|
43,648
|
|
|
$
|
48,518
|
|
|
$
|
76,073
|
|
|
$
|
124,591
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Contingent consideration
|
|
$
|
—
|
|
|
$
|
34,800
|
|
|
$
|
34,800
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Level 3
|
||
Balance at December 31, 2011
|
$
|
—
|
|
Amount acquired on June 12, 2012
|
35,100
|
|
|
Fair value adjustment recorded within selling, general and administrative expenses
|
(300
|
)
|
|
Balance at December 31, 2012
|
$
|
34,800
|
|
|
December 31,
|
||||||
|
2012
|
|
2011
|
||||
Raw materials
|
$
|
9,179
|
|
|
$
|
1,937
|
|
Work in process
|
1,210
|
|
|
524
|
|
||
Finished goods
|
16,136
|
|
|
1,448
|
|
||
Total inventories
|
$
|
26,525
|
|
|
$
|
3,909
|
|
|
December 31,
|
||||||
|
2012
|
|
2011
|
||||
Computer software
|
$
|
4,292
|
|
|
$
|
4,010
|
|
Leasehold improvements
|
3,899
|
|
|
763
|
|
||
Computer equipment
|
3,687
|
|
|
2,046
|
|
||
Furniture and fixtures
|
1,953
|
|
|
556
|
|
||
Construction-in-progress
|
1,135
|
|
|
689
|
|
||
Machinery and equipment
|
94
|
|
|
76
|
|
||
Subtotal
|
15,060
|
|
|
8,140
|
|
||
Less accumulated depreciation and amortization
|
(7,779
|
)
|
|
(6,583
|
)
|
||
Property and equipment, net
|
$
|
7,281
|
|
|
$
|
1,557
|
|
|
December 31,
|
||||||
|
2012
|
|
2011
|
||||
Rebates and other sales deductions
|
$
|
29,235
|
|
|
$
|
12,378
|
|
Sales returns reserve
|
26,385
|
|
|
4,302
|
|
||
Employee compensation and benefits
|
24,900
|
|
|
11,643
|
|
||
Royalties
|
3,271
|
|
|
267
|
|
||
Professional fees
|
2,163
|
|
|
4,021
|
|
||
Other
|
18,712
|
|
|
2,172
|
|
||
Total accrued liabilities
|
$
|
104,666
|
|
|
$
|
34,783
|
|
Balance at December 31, 2011
|
$
|
38,213
|
|
Goodwill arising from the Azur Merger
|
201,524
|
|
|
Goodwill arising from the EUSA Acquisition
|
206,452
|
|
|
Goodwill allocated to the divested women’s health business (1)
|
(12,916
|
)
|
|
Foreign exchange
|
9,327
|
|
|
Balance at December 31, 2012
|
$
|
442,600
|
|
(1)
|
In 2012, we sold our women’s health business. See Note 19 for information regarding discontinued operations.
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||||||||||||
|
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
|
12.3
|
|
$
|
930,834
|
|
|
$
|
(97,578
|
)
|
|
$
|
833,256
|
|
|
$
|
49,400
|
|
|
$
|
(35,634
|
)
|
|
$
|
13,766
|
|
Trademarks
|
2.0
|
|
2,600
|
|
|
(2,054
|
)
|
|
546
|
|
|
2,600
|
|
|
(1,781
|
)
|
|
819
|
|
||||||
Total finite-lived intangible assets
|
|
|
933,434
|
|
|
(99,632
|
)
|
|
833,802
|
|
|
52,000
|
|
|
(37,415
|
)
|
|
14,585
|
|
||||||
Acquired IPR&D assets
|
|
|
36,150
|
|
|
—
|
|
|
36,150
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Total intangible assets
|
|
|
$
|
969,584
|
|
|
$
|
(99,632
|
)
|
|
$
|
869,952
|
|
|
$
|
52,000
|
|
|
$
|
(37,415
|
)
|
|
$
|
14,585
|
|
Year Ending December 31,
|
Estimated Amortization Expense
|
||
2013
|
$
|
77,432
|
|
2014
|
77,232
|
|
|
2015
|
71,190
|
|
|
2016
|
67,868
|
|
|
2017
|
67,868
|
|
|
Thereafter
|
472,212
|
|
|
Total
|
$
|
833,802
|
|
Year ending December 31,
|
Scheduled Term Loan Maturities
|
||
2013
|
$
|
29,688
|
|
2014
|
41,563
|
|
|
2015
|
47,500
|
|
|
2016
|
59,375
|
|
|
2017
|
71,250
|
|
|
Thereafter
|
213,750
|
|
|
Total
|
$
|
463,126
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Rent expense
|
$
|
3,074
|
|
|
$
|
2,593
|
|
|
$
|
2,323
|
|
Year ending December 31,
|
Lease
Payments
|
||
2013
|
$
|
6,631
|
|
2014
|
6,100
|
|
|
2015
|
5,493
|
|
|
2016
|
4,067
|
|
|
2017
|
2,445
|
|
|
Total
|
$
|
24,736
|
|
|
As of
December 31,
2012
|
|
2011 Equity Incentive Plan
|
7,344
|
|
2007 Equity Incentive Plan
|
1,000
|
|
2007 Employee Stock Purchase Plan
|
851
|
|
Amended and Restated 2007 Non-Employee Directors Stock Option Plan
|
374
|
|
Amended and Restated Directors Deferred Compensation Plan
|
183
|
|
Exercise of warrants
|
2,023
|
|
Total
|
11,775
|
|
Warrants Issued
|
Expiration Date
|
|
Shares of
Common Stock
|
|
Exercise
Price
|
|||
Warrants issued in 2008 in conjunction with long-term debt
|
March 16, 2013
|
|
471
|
|
|
$
|
9.34
|
|
Warrants issued in 2008 in conjunction with registered direct public offering
|
July 20, 2014
|
|
604
|
|
|
$
|
7.37
|
|
Warrants issued in 2009 in conjunction with private placement
|
July 5, 2016
|
|
948
|
|
|
$
|
4.00
|
|
|
|
|
2,023
|
|
|
|
|
Net Unrealized Gains (Losses) On Available-For-Sale Securities
|
|
Foreign Currency Translation Adjustments
|
|
Total Accumulated Other Comprehensive Income/(Loss)
|
||||||
Balance at December 31, 2011
|
$
|
(31
|
)
|
|
$
|
—
|
|
|
$
|
(31
|
)
|
Other comprehensive income
|
31
|
|
|
31,046
|
|
|
31,077
|
|
|||
Balance at December 31, 2012
|
$
|
—
|
|
|
$
|
31,046
|
|
|
$
|
31,046
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Grant date fair value
|
$
|
25.28
|
|
|
$
|
17.38
|
|
|
$
|
7.84
|
|
Volatility
|
64
|
%
|
|
72
|
%
|
|
85
|
%
|
|||
Expected term (years)
|
4.6
|
|
|
5.2
|
|
|
6.0
|
|
|||
Range of risk-free rates
|
0.5-1.1%
|
|
|
0.0-2.7%
|
|
|
1.5-3.1%
|
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011(1)
|
|
2010
|
||||||
Selling, general and administrative
|
$
|
18,950
|
|
|
$
|
15,592
|
|
|
$
|
5,924
|
|
Research and development
|
2,640
|
|
|
4,488
|
|
|
2,004
|
|
|||
Cost of product sales
|
1,416
|
|
|
624
|
|
|
291
|
|
|||
Total share-based compensation expense, pre-tax
|
23,006
|
|
|
20,704
|
|
|
8,219
|
|
|||
Tax benefit from share-based compensation expense
|
(7,499
|
)
|
|
—
|
|
|
—
|
|
|||
Total share-based compensation expense, net of tax
|
$
|
15,507
|
|
|
$
|
20,704
|
|
|
$
|
8,219
|
|
(1)
|
Includes expense of
$7.3 million
related to the acceleration of vesting in December 2011 of certain non-qualified share options held by
17
executives and non-employee directors in connection with the Azur Merger, of which
$6.9 million
was recorded in selling, general and administrative and
$0.4 million
was recorded in research and development.
|
|
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, 2012
|
5,506
|
|
|
$
|
16.00
|
|
|
|
|
|
||
Options granted
|
2,158
|
|
|
49.20
|
|
|
|
|
|
|||
Options exercised
|
(3,163
|
)
|
|
15.05
|
|
|
|
|
|
|||
Options forfeited
|
(323
|
)
|
|
34.54
|
|
|
|
|
|
|||
Options expired
|
—
|
|
|
—
|
|
|
|
|
|
|||
Outstanding at December 31, 2012
|
4,178
|
|
|
32.21
|
|
|
8.2
|
|
$
|
88,174
|
|
|
Vested and expected to vest at December 31, 2012
|
3,728
|
|
|
30.86
|
|
|
8.0
|
|
83,683
|
|
||
Exercisable at December 31, 2012
|
1,306
|
|
|
13.86
|
|
|
6.4
|
|
51,463
|
|
|
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, 2012
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||
RSUs granted
|
1,040
|
|
|
49.24
|
|
|
|
|
|
|||
RSUs released
|
—
|
|
|
—
|
|
|
|
|
|
|||
RSUs forfeited
|
(84
|
)
|
|
51.44
|
|
|
|
|
|
|||
RSUs expired
|
—
|
|
|
—
|
|
|
|
|
|
|||
Outstanding at December 31, 2012
|
956
|
|
|
49.04
|
|
|
1.9
|
|
$
|
50,899
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Xyrem
|
$
|
378,663
|
|
|
$
|
233,348
|
|
|
$
|
142,630
|
|
Erwinaze/Erwinase
|
72,083
|
|
|
—
|
|
|
—
|
|
|||
Prialt
|
26,360
|
|
|
—
|
|
|
—
|
|
|||
Psychiatry:
|
|
|
|
|
|
||||||
Luvox CR
|
42,419
|
|
|
33,170
|
|
|
27,376
|
|
|||
FazaClo LD
|
22,023
|
|
|
—
|
|
|
—
|
|
|||
FazaClo HD
|
12,047
|
|
|
—
|
|
|
—
|
|
|||
Other
|
26,932
|
|
|
—
|
|
|
—
|
|
|||
Product sales, net
|
580,527
|
|
|
266,518
|
|
|
170,006
|
|
|||
Royalties and contract revenues
|
5,452
|
|
|
5,759
|
|
|
3,775
|
|
|||
Total revenues
|
$
|
585,979
|
|
|
$
|
272,277
|
|
|
$
|
173,781
|
|
|
Year Ended December 31,
|
|||||||
|
2012
|
|
2011
|
|
2010
|
|||
Express Scripts
|
64
|
%
|
|
85
|
%
|
|
82
|
%
|
|
December 31,
|
||||||
|
2012
|
|
2011
|
||||
Ireland
|
$
|
2,437
|
|
|
$
|
—
|
|
United States
|
4,451
|
|
|
1,557
|
|
||
Other
|
393
|
|
|
—
|
|
||
Total long-lived assets (1)
|
$
|
7,281
|
|
|
$
|
1,557
|
|
(1)
|
Long-lived assets consist of property and equipment.
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Republic of Ireland
|
$
|
(73,949
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
United States
|
250,348
|
|
|
124,984
|
|
|
32,778
|
|
|||
Other
|
956
|
|
|
—
|
|
|
—
|
|
|||
Total
|
$
|
177,355
|
|
|
$
|
124,984
|
|
|
$
|
32,778
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Current
|
|
|
|
|
|
||||||
Republic of Ireland
|
$
|
(10,733
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
United States
|
33,387
|
|
|
—
|
|
|
—
|
|
|||
Other
|
7,414
|
|
|
—
|
|
|
—
|
|
|||
Total current income tax
|
30,068
|
|
|
—
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Deferred
|
|
|
|
|
|
||||||
Republic of Ireland
|
(315
|
)
|
|
—
|
|
|
—
|
|
|||
United States
|
(103,932
|
)
|
|
—
|
|
|
—
|
|
|||
Other
|
(9,615
|
)
|
|
—
|
|
|
—
|
|
|||
Total deferred income tax benefit
|
(113,862
|
)
|
|
—
|
|
|
—
|
|
|||
Total income tax benefit
|
$
|
(83,794
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Statutory income tax rate
|
12.5
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
|||
|
|
|
|
|
|
||||||
Income tax provision at statutory rate
|
$
|
22,169
|
|
|
43,744
|
|
|
11,472
|
|
||
Acquisition-related costs
|
763
|
|
|
3,552
|
|
|
—
|
|
|||
Research and other tax credits
|
(100
|
)
|
|
(1,323
|
)
|
|
(380
|
)
|
|||
Share-based compensation
|
873
|
|
|
670
|
|
|
1,083
|
|
|||
Foreign income tax rate differential
|
52,066
|
|
|
—
|
|
|
—
|
|
|||
Uncertain tax positions
|
2,249
|
|
|
—
|
|
|
—
|
|
|||
Prior period adjustments
|
(2,524
|
)
|
|
—
|
|
|
—
|
|
|||
Other
|
(132
|
)
|
|
353
|
|
|
(80
|
)
|
|||
Change in valuation allowance
|
(159,158
|
)
|
|
(46,996
|
)
|
|
(12,095
|
)
|
|||
Income tax benefit
|
$
|
(83,794
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Effective income tax rate
|
(47.2
|
)%
|
|
—
|
%
|
|
—
|
%
|
|
December 31,
|
|||||||
|
2012
|
|
2011
|
|||||
Deferred tax assets:
|
|
|
|
|||||
Net operating loss carryforwards
|
$
|
71,636
|
|
|
$
|
67,762
|
|
|
Tax credit carryforwards
|
6,034
|
|
|
15,140
|
|
|||
Intangible assets
|
13,940
|
|
|
8,309
|
|
|||
Share-based compensation
|
3,875
|
|
|
6,293
|
|
|||
Accruals
|
32,594
|
|
|
8,188
|
|
|||
Deferred revenue and other
|
13,797
|
|
|
5,496
|
|
|||
Total deferred tax assets
|
141,876
|
|
|
111,188
|
|
|||
Valuation allowance
|
(17,471
|
)
|
|
(111,188
|
)
|
|||
Net deferred tax assets
|
124,405
|
|
|
—
|
|
|||
Deferred tax liabilities:
|
|
—
|
|
|
||||
Acquired intangible assets
|
(191,341
|
)
|
|
—
|
|
|||
Other
|
(1,069
|
)
|
|
—
|
|
|||
Net deferred tax liabilities
|
$
|
(68,005
|
)
|
|
$
|
—
|
|
|
Year Ended December 31,
|
||||||
|
2012
|
|
2011
|
||||
Current deferred tax assets
|
$
|
35,813
|
|
|
$
|
—
|
|
Current deferred tax liabilities
|
(275
|
)
|
|
—
|
|
||
Non-current deferred tax assets
|
74,850
|
|
|
—
|
|
||
Non-current deferred tax liabilities
|
(178,393
|
)
|
|
—
|
|
||
Net deferred tax liabilities
|
$
|
(68,005
|
)
|
|
$
|
—
|
|
|
December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Balance at the beginning of the year
|
$
|
3,764
|
|
|
$
|
4,852
|
|
|
$
|
4,711
|
|
Increases related to current year tax positions
|
3,492
|
|
|
242
|
|
|
164
|
|
|||
Increases related to prior year tax positions
|
40
|
|
|
213
|
|
|
—
|
|
|||
Decreases related to prior year tax positions
|
(8
|
)
|
|
(1,543
|
)
|
|
—
|
|
|||
Lapse of applicable statute of limitations
|
—
|
|
|
—
|
|
|
(23
|
)
|
|||
Balance at the end of the year
|
$
|
7,288
|
|
|
$
|
3,764
|
|
|
$
|
4,852
|
|
|
Total Termination Benefits
|
||
Balance at January 1, 2012
|
$
|
—
|
|
Costs incurred during the period
|
2,789
|
|
|
Cash payments
|
(1,562
|
)
|
|
Balance at December 31, 2012
|
$
|
1,227
|
|
|
Year Ended
December 31, 2012
|
||
Product sales, net
|
$
|
20,873
|
|
|
|
||
Loss from discontinued operations before income taxes
|
$
|
(5,787
|
)
|
Income tax expense (1)
|
(2,020
|
)
|
|
Loss from discontinued operations, net of taxes
|
(7,807
|
)
|
|
Gain on sale of discontinued operations (2)
|
35,244
|
|
|
Income from discontinued operations, net of taxes
|
$
|
27,437
|
|
|
2012
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Revenues (1)
|
$
|
102,530
|
|
|
$
|
124,231
|
|
|
$
|
175,515
|
|
|
$
|
183,703
|
|
Gross margin (1)(2)
|
93,708
|
|
|
110,714
|
|
|
141,501
|
|
|
156,179
|
|
||||
Income from continuing operations
|
30,235
|
|
|
31,113
|
|
|
33,595
|
|
|
166,206
|
|
||||
Income (loss) from discontinued operations
|
(2,554
|
)
|
|
(3,968
|
)
|
|
(386
|
)
|
|
34,345
|
|
||||
Net income
|
27,681
|
|
|
27,145
|
|
|
33,209
|
|
|
200,551
|
|
||||
Net income per ordinary share, basic
|
0.51
|
|
|
0.48
|
|
|
0.58
|
|
|
3.46
|
|
||||
Net income per ordinary share, diluted
|
0.48
|
|
|
0.45
|
|
|
0.55
|
|
|
3.28
|
|
|
2011
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Revenues
|
$
|
50,881
|
|
|
$
|
64,567
|
|
|
$
|
73,293
|
|
|
$
|
83,536
|
|
Gross margin (2)
|
47,094
|
|
|
60,094
|
|
|
68,315
|
|
|
77,073
|
|
||||
Net income
|
21,827
|
|
|
33,202
|
|
|
32,482
|
|
|
37,473
|
|
||||
Net income per ordinary share, basic
|
0.54
|
|
|
0.81
|
|
|
0.77
|
|
|
0.88
|
|
||||
Net income per ordinary share, diluted
|
0.48
|
|
|
0.71
|
|
|
0.69
|
|
|
0.79
|
|
(1)
|
In 2012, we sold our women’s health business. The women’s health business met the discontinued operations criteria in the third quarter of 2012. See Note 19 for information regarding discontinued operations. As a result, revenues and gross margin for the first two quarters of 2012 have been restated to reflect only our continuing operations. There was no effect on previously reported net income. Below is a reconciliation of the revenues and gross margin amounts as previously reported in our quarterly reports on Form 10-Q to the restated amounts reported above.
|
|
2012
|
||||||
|
March 31
|
|
June 30
|
||||
Revenues, as previously reported
|
$
|
108,414
|
|
|
$
|
129,539
|
|
Less product sales from discontinued operations
|
(5,884
|
)
|
|
(5,308
|
)
|
||
Revenues, as adjusted
|
$
|
102,530
|
|
|
$
|
124,231
|
|
|
|
|
|
||||
Gross margin, as previously reported
|
$
|
96,578
|
|
|
$
|
112,940
|
|
Less gross margin from discontinued operations
|
(2,870
|
)
|
|
(2,226
|
)
|
||
Gross margin, as adjusted
|
$
|
93,708
|
|
|
$
|
110,714
|
|
(2)
|
Gross margin excludes amortization of acquired developed technology of
$10.7 million
,
$12.9 million
,
$19.7 million
and
$21.8 million
in the first, second, third and fourth quarters of 2012, respectively, and
$1.8 million
in each quarter of 2011.
|
•
|
We completed the Azur Merger on January 18, 2012 and the EUSA Acquisition on June 12, 2012 and contributions of the acquired businesses to our total revenues from continuing operations were
$18.4 million
,
$23.5 million
,
$59.9 million
and
$59.6 million
in the first, second, third and fourth quarters of 2012, respectively, as measured from the date of each acquisition. The portion of gross margin and net income associated with the acquired businesses was not separately identifiable due to the integration with our operations;
|
•
|
A gain from the sale of our women’s health business of $
35.2 million
recorded in the fourth quarter of 2012;
|
•
|
A tax benefit of
$104.2 million
on the release of an income tax valuation allowance in the fourth quarter of 2012;
|
•
|
Acquisition accounting inventory fair value step-up adjustments in continuing operations of
$1.3 million
,
$3.0 million
,
$10.3 million
and
$2.1 million
in the first, second, third and fourth quarters of 2012, respectively;
|
•
|
Transaction costs of
$3.5 million
and
$8.9 million
in the first and second quarters of 2012, respectively;
|
•
|
Transaction costs of
$6.0 million
and
$5.3 million
related to the Azur Merger were recorded in the third and fourth quarters of 2011, respectively;
|
•
|
Share-based compensation expense of
$7.3 million
recorded in the fourth quarter of 2011 as a result of the vesting acceleration of non-qualified share options held by certain executives and non-employee directors; and
|
•
|
A loss on extinguishment of debt of
$1.1 million
in the third quarter of 2011.
|
|
|
|
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, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Allowance for doubtful accounts
|
(1
|
)
|
|
$
|
50
|
|
|
$
|
678
|
|
|
$
|
—
|
|
|
$
|
(13
|
)
|
|
$
|
715
|
|
Allowance for sales discounts
|
(1
|
)
|
|
296
|
|
|
6,022
|
|
|
—
|
|
|
(5,790
|
)
|
|
528
|
|
|||||
Allowance for chargebacks
|
(1
|
)
|
|
20
|
|
|
13,072
|
|
|
—
|
|
|
(10,556
|
)
|
|
2,536
|
|
|||||
Deferred tax asset valuation allowance
|
(2),(3)
|
|
|
111,188
|
|
|
3,421
|
|
|
62,971
|
|
|
(160,109
|
)
|
|
17,471
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
For the year ended December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Allowance for doubtful accounts
|
(1
|
)
|
|
$
|
50
|
|
|
$
|
3
|
|
|
$
|
—
|
|
|
$
|
(3
|
)
|
|
$
|
50
|
|
Allowance for sales discounts
|
(1
|
)
|
|
420
|
|
|
3,604
|
|
|
—
|
|
|
(3,728
|
)
|
|
296
|
|
|||||
Allowance for chargebacks
|
(1
|
)
|
|
12
|
|
|
451
|
|
|
—
|
|
|
(443
|
)
|
|
20
|
|
|||||
Deferred tax asset valuation allowance
|
(3
|
)
|
|
155,519
|
|
|
—
|
|
|
—
|
|
|
(44,331
|
)
|
|
111,188
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
For the year ended December 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Allowance for doubtful accounts
|
(1
|
)
|
|
$
|
50
|
|
|
$
|
(9
|
)
|
|
$
|
—
|
|
|
$
|
9
|
|
|
$
|
50
|
|
Allowance for sales discounts
|
(1
|
)
|
|
238
|
|
|
3,829
|
|
|
—
|
|
|
(3,647
|
)
|
|
420
|
|
|||||
Allowance for chargebacks
|
(1
|
)
|
|
—
|
|
|
233
|
|
|
—
|
|
|
(221
|
)
|
|
12
|
|
|||||
Deferred tax asset valuation allowance
|
(3
|
)
|
|
162,661
|
|
|
—
|
|
|
—
|
|
|
(7,142
|
)
|
|
155,519
|
|
(1)
|
Shown as a reduction of accounts receivable. Charges related to sales discounts and chargebacks are reflected as a reduction of revenue.
|
(2)
|
Other additions to the deferred income tax asset valuation allowance resulted from the Azur Merger and the EUSA Acquisition.
|
(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.
|
Exhibit
Number
|
|
Description of Document
|
2.1
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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).
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2.2
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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).
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2.3
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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).
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2.4
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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).
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2.5
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Asset Purchase Agreement, dated as of September 5, 2012, by and among Jazz Pharmaceuticals plc, Jazz Pharmaceuticals International II Limited, Meda Pharmaceuticals Inc. and Meda Pharma, Sàrl (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 October 15, 2012).
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3.1
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Memorandum and Articles of Association of Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
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4.1
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Reference is made to Exhibit 3.1.
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4.2A
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Third Amended and Restated Investor Rights Agreement, made effective as of June 6, 2007, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3 in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2007, as filed with the SEC on August 10, 2007).
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4.2B
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Waiver and Amendment Agreement, dated as of March 12, 2008, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3B in Jazz Pharmaceuticals, Inc.’s annual report on Form 10-K (File No. 001-33500), for the period ended December 31, 2007, as filed with the SEC on March 31, 2008).
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4.2C
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Waiver and Amendment Agreement, dated as of May 7, 2008, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3C in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on May 9, 2008).
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4.2D
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Waiver and Amendment Agreement, dated as of July 6, 2009, by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 4.3D in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2009, as filed with the SEC on August 14, 2009).
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4.2E
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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 4.2E 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).
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4.3
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Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 4.4 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).
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4.4
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Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Registered Direct Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 4.5 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).
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4.5
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Form of Jazz Pharmaceuticals plc Warrant to Purchase Ordinary Shares issued to holders of assumed Common Stock Warrants originally issued by Jazz Pharmaceuticals, Inc. on July 7, 2009 (incorporated herein by reference to Exhibit 4.6 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).
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4.6A
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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).
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4.6B
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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).
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4.7
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Registration Rights Agreement made as of January 13, 2012, by and among Jazz Pharmaceuticals plc and certain shareholders named therein (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
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10.1†
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Xyrem Manufacturing Services and Supply Agreement, dated as of March 13, 2007, by and between Jazz Pharmaceuticals, Inc. and Patheon Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.50 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on May 31, 2007).
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10.2†
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Quality Agreement, dated as of March 13, 2007, by and between Jazz Pharmaceuticals, Inc. and Patheon Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.51 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).
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10.3†
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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).
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10.4
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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).
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10.5
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Escrow Agreement made and entered into as of January 18, 2012, by and among Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., Seamus Mulligan, solely in his capacity as Indemnitors’ Representative, and Deutsche Bank National Trust Association, as escrow agent (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
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10.6†
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Royalty Bearing License Agreement and Supply Agreement Re Erwinia-Derived Asparaginase, dated July 22, 2005, between the 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), as filed with the SEC on August 9, 2012).
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10.7
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Credit Agreement, dated as of June 12, 2012, by and among Jazz Pharmaceuticals plc, Jazz Pharmaceuticals, Inc., the Lenders and Barclays Bank PLC, as Administrative Agent, Collateral 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 12, 2012).
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10.8
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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).
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10.9
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Lease Agreement, dated October 20, 2008, between Seamus Mulligan, as lessor, and Jazz Pharmaceuticals plc, as lessee (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-4 (File No. 333-177528), as filed with the SEC on October 26, 2011).
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10.10
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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).
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10.11
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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).
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10.12
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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), as filed with the SEC on August 7, 2012).
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10.13
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Surrender of Lease of 45 Fitzwilliam Square Dublin 2, dated November 9, 2012, between Seamus Mulligan, as lessor, and Jazz Pharmaceuticals plc, as lessee.
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10.14+
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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).
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10.15+
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Offer Letter from Jazz Pharmaceuticals, Inc. to Kathryn Falberg (incorporated herein by reference to Exhibit 10.92 in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on December 3, 2009).
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10.16+
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Employment Agreement by and between Seamus Mulligan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s registration statement on Form S-4 (File No. 333-177528), as filed with the SEC on October 26, 2011).
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10.17+
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Noncompetition Agreement by and between Seamus Mulligan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s registration statement on Form S-4 (File No. 333-177528), as filed with the SEC on October 26, 2011).
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10.18+
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Offer Letter from Jazz Pharmaceuticals, Inc. to Jeffrey Tobias, M.D. (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on November 8, 2011).
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10.19+
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Separation Agreement, dated January 18, 2012, by and between Jazz Pharmaceuticals plc and Carol Gamble (incorporated herein by reference to Exhibit 10.27 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).
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10.20+
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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), as filed with the SEC on May 8, 2012).
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10.21+
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Amendment to Employment Agreement by and between Jazz Pharmaceuticals plc and Seamus Mulligan (incorporated herein by reference to Exhibit 10.20 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on May 8, 2012).
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10.22+
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Employment Agreement by and between Fintan Keegan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 7, 2012).
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10.23+
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Amendment to Employment Agreement by and between Fintan Keegan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 7, 2012).
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10.24+
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Noncompetition Agreement by and between Fintan Keegan and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500), as filed with the SEC on August 7, 2012).
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10.25A
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Civil Settlement Agreement, dated July 13, 2007, among the United States of America acting through the entities named therein, Jazz Pharmaceuticals, Inc. and Orphan Medical, Inc. (incorporated herein by reference to Exhibit 10.57A in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
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10.25B
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Non-Prosecution Agreement, dated July 13, 2007, between the United States Attorney’s Office for the Eastern District of New York and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.57B in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
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10.25C
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Plea Agreement, dated July 13, 2007, between the United States Attorney for the Eastern District of New York and Orphan Medical, Inc. (incorporated herein by reference to Exhibit 10.57C in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
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10.25D
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Corporate Integrity Agreement, dated July 13, 2007, between the Office of Inspector General of the Department of Health and Human Services and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.57D in Jazz Pharmaceuticals, Inc.’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on July 18, 2007).
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10.26A+
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Jazz Pharmaceuticals plc 2003 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.5 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
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10.26B+
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Form of Option Exercise and Stock Purchase Agreement and Forms of Grant Notices under the Jazz Pharmaceuticals, Inc. 2003 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.22 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on May 17, 2007).
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10.26C+
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Form of Letter, amending outstanding options granted under the Jazz Pharmaceuticals, Inc. 2003 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.60 in Jazz Pharmaceuticals, Inc.’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2007, as filed with the SEC on August 10, 2007).
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10.27A+
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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).
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10.27B+
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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).
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10.27C+
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Form of
Notice of Grant of Stock Options and Form of Option Agreement
(U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan.
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10.27D+
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Form of
Notice of Grant of Stock Options and Form of Option Agreement
(Irish) under Jazz Pharmaceuticals plc 2007 Equity Incentive Plan.
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10.27E+
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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.
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10.27F+
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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.
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10.28A+
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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).
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10.28B+
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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).
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10.28C+
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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), as filed with the SEC on August 7, 2012).
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10.28D+
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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), as filed with the SEC on August 7, 2012).
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10.28E+
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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.
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10.28F+
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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), as filed with the SEC on August 7, 2012).
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10.28G+
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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), as filed with the SEC on August 7, 2012).
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10.28H+
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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.
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10.29+
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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).
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10.30A+
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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).
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10.30B+
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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.
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10.31A+
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Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan, as amended and restated.
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10.31B+
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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 10.4C 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 August 7, 2012).
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10.32A+
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Jazz Pharmaceuticals plc Cash Bonus Plan, (incorporated herein by reference to Exhibit 10.33 in the annual report on Form 10-K/A (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 April 27, 2012).
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10.32B+
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Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates.
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10.32C+
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Jazz Pharmaceuticals Cash Bonus Plan for International Affiliates (2013).
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10.33+
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Jazz Pharmaceuticals plc Amended and Restated Executive Change in Control and Severance Benefit Plan (incorporated herein by reference to Exhibit 10.34 in the annual report on Form 10-K/A (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 April 27, 2012).
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10.34+
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Jazz Pharmaceuticals plc 2012 Non-Employee Director Compensation Arrangements (incorporated herein by reference to Exhibit 10.32 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).
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10.35+
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Jazz Pharmaceuticals plc 2012 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 June 30, 2012, as filed with the SEC on August 7, 2012).
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21.1
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Subsidiaries of Jazz Pharmaceuticals plc.
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23.1
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Consent of KPMG, Independent Registered Public Accounting Firm.
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23.2
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Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
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24.1
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Power of Attorney (included on the signature page hereto).
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31.1
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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.
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31.2
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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.
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32.1*
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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.
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101.INS++
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XBRL Instance Document
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101.SCH++
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XBRL Taxonomy Extension Schema Document
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101.CAL++
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XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF++
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XBRL Taxonomy Extension Definition Linkbase Document.
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101.LAB++
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XBRL Taxonomy Extension Labels Linkbase Document
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101.PRE++
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XBRL Taxonomy Extension Presentation Linkbase Document
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+
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Indicates management contract or compensatory plan.
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†
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Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
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*
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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.
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++
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Pursuant to applicable securities laws and regulations, the Registrant is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as the Registrant has made a good faith attempt to comply with the submission requirements and promptly amends the interactive data files after becoming aware that the interactive data files fails to comply with the submission requirements. These interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under these sections.
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(1)
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JAZZ PHARMACEUTICALS PLC
(formerly known as Azur Pharma Limited) having its registered office at 4
th
Floor, Connaught House, 1 Burlington Road, Dublin 4 (hereinafter called the
Tenant
which expression shall where the context so admits or requires include the Tenant’s successors) of the one part; and
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(2)
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SEAMUS MULLIGAN
of Wood O’Berries, Barrymore, Athlone, County Roscommon (hereinafter called the
Landlord
which expression shall where the context so admits or requires include the Landlord’s executors, administrators and assigns) of the other part
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A.
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By a Lease (hereinafter called the
Lease
) dated the 20
th
day of October 2008 and made between the Landlord of the one part and the Tenant of the other part the premises more particularly described in the First Schedule to the Lease and the Schedule hereto (the
Demised Premises
) were demised to the Tenant for the term of 21 years from the 20
th
day of October 2008 (the
Leasehold Term
) subject to the payment of the rents thereby reserved and to the observance and performance of the covenants on the part of the Tenant and conditions therein contained.
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B.
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The Tenant has requested the Landlord to accept a surrender of all its estate right title and interest in the Demised Premises comprised in and demised by the Lease free from incumbrances with effect from 31 October 2012 for the sum of $1.2 million (one million two hundred thousand dollars) which the Landlord has agreed to do.
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1.
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OPERATIVE PROVISIONS
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1.1.
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In pursuance of the agreement and in consideration of the sum of $1.2 million (one million two hundred thousand dollars) now paid by the Tenant to the Landlord (the receipt of which sum the Landlord acknowledges) the Tenant as beneficial owner assigns and surrenders the Demised Premises to the Landlord for all the unexpired residue of the Leasehold Term and all other estate, interest or rights of the Tenant in the Demised Premises whether granted by or arising from the Lease or by any deeds or documents supplemental to the Lease or otherwise
TO THE INTENT
that the Leasehold Term shall merge in the freehold reversion and become extinguished and the Landlord
HEREBY RELEASES AND DISCHARGES
the Tenant from all future claims and demands in respect of its obligations under the Leases in respect of the Demised Premises.
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1.2.
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The Tenant hereby acknowledges and confirms that it is the only occupier of the Demised Premises and that no other party (other than the Landlord) has any interest in the Demised Premises or an entitlement to occupy or be in possession of the Demised Premises.
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1.3.
|
The Tenant hereby acknowledges that it has no claim for compensation against the Landlord under the provisions of the Landlord and Tenant Acts 1967 to 2005 (as amended) or otherwise, arising from any works that the Tenant may have carried out to the Demised Premises and to the extent that the Tenant has any claim, the Tenant acknowledges that the within Surrender is a full and final settlement for such a claim.
|
1.4.
|
The Landlord shall have no liability to the Tenant under or in connection with this surrender nor in relation to any related matter or claim howsoever, whenever and wherever arising and whether the claim is formulated in contract and/ or tort or by reference to any other remedy or right and in whatever jurisdiction or forum.
|
1.5.
|
The Tenant shall have no liability to the Landlord under or in connection with this surrender nor in relation to any related matter or claim howsoever, whenever and wherever arising and whether the claim is formulated in contract and/ or tort or by reference to any other remedy or right and in whatever jurisdiction or forum.
|
1.6.
|
In the event that the Tenant has created a refurbishment capital good as defined by the VAT Act, any VAT liability arising in this regard shall be the sole responsibility of the Tenant.
|
1.7.
|
It is acknowledged and agreed by the Landlord that on execution of this surrender the Landlord has no right to claim for rent arrears, service charges, outgoings, dilapidations and other amounts due to it by the Tenant up to the date of the surrender arising from the Lease and the Landlord agrees and confirm that he will not bring any claim against the Tenant for any breach of covenant or condition contained in the Lease which may have occurred prior to 31 October 2012.
|
2.
|
IT IS HEREBY CERTIFIED
as follows:-
|
2.1.
|
that Section 29 (conveyance on sale combined with building agreement for dwellinghouse/apartment) of the Stamp Duties Consolidation Act, 1999, does not apply to this instrument.
|
2.2.
|
that this instrument is a surrender of property, or of a right or interest in property, not being a surrender on a sale.
|
2.3.
|
that for the purposes of Section 29 of the Companies Act, 1990 the transaction hereby effected has been approved by a Resolution of the members of the Tenant, passed as a written resolution on 13 January 2012.
|
3.0
|
all additions, alterations and improvements thereto;
|
GIVEN
under the
Common Seal
of
JAZZ PHARMACEUTICALS PLC
:-
|
/s/ Fintan Keegan
|
|
Fintan Keegan
|
|
Company Secretary
|
|
|
|
/s/ Seamus Mulligan
|
|
Seamus Mulligan
|
|
Director
|
|
|
|
/s/ Suzanne Sawochka Hooper
|
|
Suzanne Sawochka Hooper
Executive Vice President &
General Counsel
JAZZ PHARMACEUTICALS PLC
|
|
|
Vesting Schedule
:
|
[____________________________________]
|
Issuance Schedule:
|
One Ordinary Share will be issued for each RSU which vests at the time set forth in Section 4 of the Award Agreement.
|
Withholding Right:
|
¨
You may direct the Company (i) to withhold, from Ordinary Shares otherwise issuable in respect of the Award, a portion of those Ordinary Shares with an aggregate fair market value (measured as of the delivery date) equal to the amount of the applicable withholding taxes, and (ii) to make a cash payment equal to such fair market value directly to the appropriate taxing authorities, as provided in Section 11 of the Award Agreement.
|
Optionholder:
|
|
Option #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of Ordinary Shares Subject to Option:
|
|
Exercise Price (Per Ordinary Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
|
Vesting Schedule
:
|
[
______________________________________
]
|
(ii)
|
The revocation must be in written form to be valid. It is sufficient if you return the Option Agreement to the Company or the Company’s representative with language which can be understood as a refusal to conclude or honor the Option Agreement, provided the revocation is sent within the period discussed above.
|
A.
|
The individual who has received this Election (the “
Employee
”), who is employed by one of the employing companies listed in the attached schedule (the “
Employer
”) and who is eligible to receive stock options and/or restricted stock units (together, the “
Awards
”) pursuant to the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (the “
Plan
”), and
|
B.
|
Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “
Company
”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.
|
1.
|
Introduction
|
1.1
|
This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.
|
1.2
|
In this Election the following words and phrases have the following meanings:
|
(a)
|
“
Chargeable Event
” means, in relation to the Awards:
|
(i)
|
the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);
|
(ii)
|
the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);
|
(iii)
|
the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);
|
(iv)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or
|
(v)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).
|
(b)
|
“
ITEPA
” means the Income Tax (Earnings and Pensions) Act 2003.
|
(c)
|
“
SSCBA
” means the Social Security Contributions and Benefits Act 1992.
|
1.3
|
This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “
Employer’s Liability
”) which may arise on the occurrence of a Chargeable Event in respect of the Awards pursuant to section 4(4)(a) and/or paragraph 3B(1A) of Schedule 1 of the SSCBA.
|
1.4
|
This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.
|
1.5
|
This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).
|
2.
|
The Election
|
3.
|
Payment of the Employer’s Liability
|
3.1
|
The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:
|
(i)
|
by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or
|
(ii)
|
directly from the Employee by payment in cash or cleared funds; and/or
|
(iii)
|
by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“
HMRC
”) by the due date; and/or
|
(iv)
|
where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient time to enable the Company and/or the Employer to make payment to HMRC by the due date; and/or
|
(v)
|
by any other means specified in the applicable Award agreement entered into between the Employee and the Company.
|
3.2
|
The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.
|
3.3
|
The Company or the Employer agrees to remit the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days if payments are made electronically).
|
4.
|
Duration of Election
|
4.1
|
The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.
|
4.2
|
This Election will continue in effect until the earliest of the following:
|
(i)
|
the date on which the Employee and the Company agree in writing that it should cease to have effect;
|
(ii)
|
the date on which the Company serves written notice on the Employee terminating its effect;
|
(iii)
|
the date on which HMRC withdraws approval of this Election; or
|
(iv)
|
the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.
|
Registered Office:
|
EUSA Pharma
The Magdalen Centre
Oxford Science Park
Oxford, OX4 4GA
|
Company Registration Number:
|
4555273
|
Corporation Tax Reference:
|
452/76424 00934
|
Corporation Tax Address:
|
HM Revenue & Customs
CT Operations (Large & Complex Specialist)
16 North
Government Buildings
Ty Glas, Llanishen
Cardiff, CF14 5 FP
|
PAYE Reference:
|
120/WZ72892
|
|
|
|
|
_______________________________________
|
_______________________________________
|
JAZZ PHARMACEUTICALS
PLC
|
Date
|
|
|
_______________________________________
|
_______________________________________
|
[Name]
|
Date
|
|
|
|
|
_______________________________________
|
_______________________________________
|
JAZZ PHARMACEUTICALS
PLC
|
Date
|
|
|
_______________________________________
|
_______________________________________
|
[Name]
|
Date
|
Vesting Schedule
:
|
[____________________________________]
|
Issuance Schedule:
|
One Ordinary Share will be issued for each RSU which vests at the time set forth in Section 4 of the Award Agreement.
|
Consideration:
|
Participant’s Services
|
Vesting Schedule
:
|
[____________________________________]
|
Issuance Schedule:
|
One Ordinary Share will be issued for each RSU which vests at the time set forth in Section 6 of the Agreement.
|
A.
|
The individual who has received this Election (the “
Employee
”), who is employed by one of the employing companies listed in the attached schedule (the “
Employer
”) and who is eligible to receive stock options and/or restricted stock units (together, the “
Awards
”) pursuant to the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (the “
Plan
”), and
|
B.
|
Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “
Company
”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.
|
1.
|
Introduction
|
1.1
|
This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.
|
1.2
|
In this Election the following words and phrases have the following meanings:
|
(a)
|
“
Chargeable Event
” means, in relation to the Awards:
|
(i)
|
the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);
|
(ii)
|
the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);
|
(iii)
|
the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);
|
(iv)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or
|
(v)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).
|
(b)
|
“
ITEPA
” means the Income Tax (Earnings and Pensions) Act 2003.
|
(c)
|
“
SSCBA
” means the Social Security Contributions and Benefits Act 1992.
|
1.3
|
This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “
Employer’s Liability
”) which may arise on the occurrence of a Chargeable Event in respect of the Awards pursuant to section 4(4)(a) and/or paragraph 3B(1A) of Schedule 1 of the SSCBA.
|
1.4
|
This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.
|
1.5
|
This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).
|
2.
|
The Election
|
3.
|
Payment of the Employer’s Liability
|
3.1
|
The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:
|
(i)
|
by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or
|
(ii)
|
directly from the Employee by payment in cash or cleared funds; and/or
|
(iii)
|
by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“
HMRC
”) by the due date; and/or
|
(iv)
|
where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient time to enable the Company and/or the Employer to make payment to HMRC by the due date; and/or
|
(v)
|
by any other means specified in the applicable Award agreement entered into between the Employee and the Company.
|
3.2
|
The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.
|
3.3
|
The Company or the Employer agrees to remit the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days if payments are made electronically).
|
4.
|
Duration of Election
|
4.1
|
The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.
|
4.2
|
This Election will continue in effect until the earliest of the following:
|
(i)
|
the date on which the Employee and the Company agree in writing that it should cease to have effect;
|
(ii)
|
the date on which the Company serves written notice on the Employee terminating its effect;
|
(iii)
|
the date on which HMRC withdraws approval of this Election; or
|
(iv)
|
the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.
|
Registered Office:
|
EUSA Pharma
The Magdalen Centre
Oxford Science Park
Oxford, OX4 4GA
|
Company Registration Number:
|
4555273
|
Corporation Tax Reference:
|
452/76424 00934
|
Corporation Tax Address:
|
HM Revenue & Customs
CT Operations (Large & Complex Specialist)
16 North
Government Buildings
Ty Glas, Llanishen
Cardiff, CF14 5 FP
|
PAYE Reference:
|
120/WZ72892
|
Optionholder:
|
|
Option #:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of Ordinary Shares Subject to Option:
|
|
Exercise Price (Per Ordinary Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
|
Vesting Schedule:
|
[
______________________________________
]
|
(ii)
|
The revocation must be in written form to be valid. It is sufficient if you return the Option Agreement to the Company or the Company’s representative with language which can be understood as a refusal to conclude or honor the Option Agreement, provided the revocation is sent within the period discussed above.
|
A.
|
The individual who has received this Election (the “
Employee
”), who is employed by one of the employing companies listed in the attached schedule (the “
Employer
”) and who is eligible to receive stock options (the “
Awards
”) pursuant to the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (the “
Plan
”), and
|
B.
|
Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “
Company
”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.
|
1.
|
Introduction
|
1.1
|
This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.
|
1.2
|
In this Election the following words and phrases have the following meanings:
|
(a)
|
“
Chargeable Event
” means, in relation to the Awards:
|
(i)
|
the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);
|
(ii)
|
the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);
|
(iii)
|
the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);
|
(iv)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or
|
(v)
|
post-acquisition charges relating to the ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).
|
(b)
|
“
ITEPA
” means the Income Tax (Earnings and Pensions) Act 2003.
|
(c)
|
“
SSCBA
” means the Social Security Contributions and Benefits Act 1992.
|
1.3
|
This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “
Employer’s Liability
”) which may arise on the occurrence of a Chargeable Event in respect of the Awards pursuant to section 4(4)(a) and/or paragraph 3B(1A) of Schedule 1 of the SSCBA.
|
1.4
|
This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.
|
1.5
|
This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).
|
2.
|
The Election
|
3.
|
Payment of the Employer’s Liability
|
3.1
|
The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:
|
(i)
|
by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or
|
(ii)
|
directly from the Employee by payment in cash or cleared funds; and/or
|
(iii)
|
by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“
HMRC
”) by the due date; and/or
|
(iv)
|
where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient time to enable the Company and/or the Employer to make payment to HMRC by the due date; and/or
|
(v)
|
by any other means specified in the applicable Award agreement entered into between the Employee and the Company.
|
3.2
|
The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.
|
3.3
|
The Company or the Employer agrees to remit the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days if payments are made electronically).
|
4.
|
Duration of Election
|
4.1
|
The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.
|
4.2
|
This Election will continue in effect until the earliest of the following:
|
(i)
|
the date on which the Employee and the Company agree in writing that it should cease to have effect;
|
(ii)
|
the date on which the Company serves written notice on the Employee terminating its effect;
|
(iii)
|
the date on which HMRC withdraws approval of this Election; or
|
(iv)
|
the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.
|
Registered Office:
|
EUSA Pharma
The Magdalen Centre
Oxford Science Park
Oxford, OX4 4GA
|
Company Registration Number:
|
4555273
|
Corporation Tax Reference:
|
452/76424 00934
|
Corporation Tax Address:
|
HM Revenue & Customs
CT Operations (Large & Complex Specialist)
16 North
Government Buildings
Ty Glas, Llanishen
Cardiff, CF14 5 FP
|
PAYE Reference:
|
120/WZ72892
|
1.
|
GENERAL.
|
2.
|
ADMINISTRATION.
|
3.
|
ORDINARY SHARES SUBJECT TO THE PLAN.
|
4.
|
GRANT OF PURCHASE RIGHTS; OFFERING.
|
5.
|
ELIGIBILITY.
|
6.
|
PURCHASE RIGHTS; PURCHASE PRICE.
|
7.
|
PARTICIPATION; WITHDRAWAL; TERMINATION.
|
8.
|
EXERCISE OF PURCHASE RIGHTS.
|
9.
|
COVENANTS OF THE COMPANY.
|
10.
|
DESIGNATION OF BENEFICIARY.
|
11.
|
MISCELLANEOUS PROVISIONS.
|
12.
|
ADJUSTMENTS UPON CHANGES IN ORDINARY SHARES; CORPORATE TRANSACTIONS.
|
13.
|
AMENDMENT, TERMINATION OR SUSPENSION OF THE PLAN.
|
14.
|
EFFECTIVE DATE OF PLAN.
|
15.
|
DEFINITIONS.
|
Position
|
Target Bonus Range
(Percent of Base Salary) |
Chairman of the Board, Chief Executive Officer, President
|
100%
|
Executive Vice President
|
50%
|
Senior Vice President
|
40%
|
Vice President
|
25-35%
|
Senior Director/Executive Director
|
20-30%
|
Associate Director/Director
|
15-25%
|
Managers (all levels)
|
10-20%
|
Other
|
5-15%
|
Position
|
Target Bonus Range
(Percent of Base Salary) |
Chairman of the Board, Chief Executive Officer, President
|
100%
|
Executive Vice President
|
50%
|
Senior Vice President
|
40%
|
Vice President
|
25-35%
|
Senior Director/Executive Director
|
20-30%
|
Associate Director/Director
|
15-25%
|
Managers (all levels)
|
10-20%
|
Other
|
5-15%
|
Name of Subsidiary
|
|
State or Jurisdiction of Incorporation or Organization
|
Jazz Pharmaceuticals Ireland Limited
|
|
Ireland
|
Jazz Pharmaceuticals, Inc.
|
|
Delaware
|
Jazz Pharmaceuticals International Limited
|
|
Bermuda
|
Jazz Pharmaceuticals International II Limited
|
|
Bermuda
|
EUSA Pharma SAS
|
|
France
|
EUSA Pharma Holdings SAS
|
|
France
|
EUSA Pharma International Limited
|
|
Gibraltar
|
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
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b)
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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.
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Date: February 26, 2013
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By:
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/s/ Bruce C. Cozadd
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Bruce C. Cozadd
Chairman and Chief Executive Officer
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1.
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I have reviewed this Annual Report on Form 10-K of Jazz Pharmaceuticals Public Limited Company;
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2.
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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;
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3.
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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;
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4.
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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:
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a)
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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;
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b)
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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;
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c)
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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
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d)
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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
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5.
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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):
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a)
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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
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b)
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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.
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Date: February 26, 2013
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By:
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/s/ Kathryn E. Falberg
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Kathryn E. Falberg
Executive Vice President and Chief Financial Officer
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1.
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The Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 2012
, 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 Securities Exchange Act of 1934, 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
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/s/ Kathryn E. Falberg
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Kathryn E. Falberg
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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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