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Jazz Pharmaceuticals Plc Proxy Statement 2017 Annual Report

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Jazz Pharmaceuticals Plc Proxy Statement 2017 Annual Report Proxy Statement Proxy 2017 Annual Report Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc Proxy Statement — 2017 Annual Report June 15, 2018 Dear Shareholders, Over the past six years, Jazz Pharmaceuticals has evolved into an integrated global biopharmaceutical company, with deep therapeutic expertise in serious sleep disorders and hematology/oncology-related diseases. During this time, we have deployed approximately $4 billion in capital to meaningfully diversify our business, received multiple global regulatory approvals and launched two new hematology/oncology products, while making significant advancements in multiple R&D programs. Our commitment to investing in new, innovative therapeutic options for patients while driving long-term, Meet John sustainable growth for our shareholders has remained unwavering and was demonstrated by our pivotal Our cover highlights John. After working achievements in 2017. in the steel industry for 45 years, John retired in 2009 and, with his wife Cherie, In 2017, we received marketing authorization for and began traveling the world visiting family successfully launched Vyxeos® (daunorubicin and and friends and seeking new adventures. cytarabine) liposome for injection in the U.S., the first In 2013, John noticed changes in his new chemotherapy advance in more than 40 years for health. He was fatigued, bruised easily and adults with certain types of high-risk AML. We also was not his usual energetic self. Shortly announced positive results from our three Phase 3 studies thereafter, John was diagnosed with of solriamfetol for the treatment of excessive sleepiness acute myeloid leukemia, or AML, a rapidly (ES) in narcolepsy and obstructive sleep apnea (OSA) progressing and life-threatening blood and from our Phase 2/3 study of Xyrem® (sodium cancer. Given his age and limited treatment oxybate) oral solution in a pediatric narcolepsy population. options, John’s doctor advised him of a clinical We accomplished significant regulatory milestones in trial for Vyxeos (known then as CPX-351) multiple late-stage sleep and hematology/oncology clinical which, at that time, was an investigational programs, including: chemotherapy drug for patients with certain types of poor-prognosis AML. John decided to • Submission of a new drug application (NDA) for pursue this option and was enrolled in the clinical solriamfetol in the U.S. trial. John received Vyxeos and later went on to • Submission of a marketing authorization application receive a bone marrow transplant. Today, John and under an accelerated pathway for Vyxeos in the EU. Cherie are back to living each day to the fullest. • Receipt of marketing authorization for Defitelio® (defibrotide sodium) in Canada. In August 2017, the U.S. Food and Drug • Initiation of a Phase 3 study of JZP-258, our product ® Administration approved Vyxeos (daunorubicin candidate with 90% less sodium content compared and cytarabine) liposome for injection for to Xyrem, for the treatment of excessive daytime the treatment of adults with newly-diagnosed sleepiness and cataplexy in narcolepsy. therapy-related AML or AML with myelodysplasia- • Initiation of a Phase 2 study of solriamfetol for the related changes. Vyxeos represents the first new treatment of excessive sleepiness in Parkinson’s disease. chemotherapy advance in more than 40 years for adults with these two types of AML. Additionally, we diligently evaluated, and continue to The patient story shared in this communication depicts an individual evaluate, many corporate development opportunities to patient’s response to our medicine and is not representative of all expand our business and pipeline. In 2017, we were patient responses. pleased to announce collaborations with ImmunoGen, (TA-TMA). With the goal of improving therapeutic Inc. on up to three early-stage innovative antibody drug options for patients with acute lymphoblastic leukemia conjugate programs and with Nippon Shinyaku Co., Ltd. (ALL), we continue to make progress in identifying a to develop and market Defitelio and Vyxeos in Japan. new, improved and potentially long-acting crisantaspase product candidate. 2017 FINANCIAL HIGHLIGHTS In sleep medicine, we submitted a supplemental NDA for Xyrem earlier this year seeking marketing authorization In 2017 compared to 2016, full-year revenue grew for pediatric narcolepsy patients. For JZP-258, we expect 9% to $1.6 billion, with adjusted earnings per share1 to complete enrollment this year in our Phase 3 study in growth of 9% to $11.04. Investment in R&D grew 11% to narcolepsy patients to support an NDA submission in $162 million on an adjusted non-GAAP basis1 compared 2019, assuming positive safety and efficacy data. We also to 2016 to support our multiple regulatory submissions plan to initiate a Phase 3 study of JZP-258 in idiopathic and expanding R&D pipeline. We ended 2017 well- hypersomnia patients this year. For solriamfetol, we positioned to execute on corporate development continue to enroll patients in our Phase 2 study in opportunities to support our growth strategy, with cash, excessive sleepiness in Parkinson’s disease and expect cash equivalents and investments of $601 million, an to complete enrollment by year end. enhanced debt structure and $1.25 billion available under our revolving credit facility. With our strong cash position, low leverage ratio and anticipated cash generation of over $2.5 billion over the next three years, we are well-positioned to broaden CONTINUING OUR EVOLUTION our portfolio through our internal R&D efforts as well THROUGH STRATEGIC INVESTMENTS as corporate development activities, with a continued focus on long-lived, medically differentiated products With the advancements made in 2017, we are looking and programs aimed at a targeted prescriber base. forward to an eventful 2018. In 2018, we are investing to We expect these investments over time will lead to drive strong performance of our key products, further our sustainable value-creating opportunities that will drive global expansion with multiple regulatory submissions our continued global growth. and plan for several anticipated product launches. Advancing our promising R&D pipeline and bringing In closing, I am very proud of our employees whose additional innovation to our portfolio with ongoing and dedication, integrity and collaboration have brought new programs in our current therapeutic areas continue life-changing therapeutic options to patients. We are to be a priority in 2018. deeply honored to serve the unmet needs of our patients and their families around the world in fulfilling our mission In hematology/oncology, we are focused on positioning of improving patients’ lives and delivering meaningful Vyxeos as the new backbone of AML therapy, with and innovative products in the areas of sleep and multiple planned studies intended to evaluate Vyxeos hematology/oncology. both alone and in combination with targeted therapies in a variety of AML patient populations. For Defitelio, we Sincerely, are developing treatment options for rare, life-threatening conditions related to endothelial cell damage following stem cell transplant, including the prevention of hepatic veno-occlusive disease (VOD), prevention of acute graft- versus-host disease (aGvHD) and the treatment Bruce C. Cozadd of transplant-associated thrombotic microangiopathy Chairman and Chief Executive Officer Expanding R&D Pipeline PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY Oxybate IMGN779 Solriamfetol for ES in JZP-258 Solriamfetol for ES in Once-Nightly Dosing for R/R Parkinson's Disease for Narcolepsy OSA and Narcolepsy CD33+ AML Complete enrollment Complete enrollment PDUFA date Dec 20, by YE18 by 4Q18 2018; EU submission expected late 2018 Asparaginase IMGN632 for Defibrotide JZP-258 for Xyrem for for ALL/other hematological for prevention Idiopathic Pediatric Narcolepsy hematological malignancies of aGvHD Hypersomnia sNDA submitted 2Q18 malignancies First patient in 1Q18 Phase 3 study initiation planned 2H18 CombiPlex Defibrotide Defibrotide for Vyxeos for Pre-clinical evaluation for TA-TMA prevention of VOD High-Risk AML of oncology therapeutic Pivotal Phase 2 study site First patient in 1Q17 Potential EU approval combinations activation planned 4Q18 expected as early as summer 2018 Recombinant Vyxeos for pegaspargase Myelodysplastic for hematological Syndrome Sleep malignancies Phase 2 study initiation Hematology/Oncology planned 2H18 (co-op group) Opt-in Opportunity Financial Performance Total Revenues Net Income per Diluted Share (in millions) $1,800 $12.00 GAAP Non-GAAP Adjusted (unaudited)1 1,619 $110 $1488 $10.1 $9.45 $1,200 $12 $8.00 $796 $6.41 $52 $600 $4.00 $0 $0.00 2015 2016 2017 2015 2016 2017 1 Reconciliations of GAAP reported net income (and related per share amounts) to non-GAAP adjusted net income (and related per share amounts) for 2015, 2016 and 2017 and reconciliations of GAAP R&D expense to non-GAAP adjusted R&D expense for 2016 and 2017 can be found on page 54 of the enclosed Proxy Statement. JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY Registered in Ireland – No. 399192 Fifth Floor, Waterloo Exchange Waterloo Road Dublin 4, Ireland NOTICE OF 2018 ANNUAL GENERAL MEETING OF SHAREHOLDERS TO BE HELD ON AUGUST 2, 2018 Proxy Dear Shareholder: You are cordially invited to attend the 2018 annual general meeting of shareholders (the “annual meeting”) of Jazz Pharmaceuticals plc, a public limited company formed under the laws of Ireland (the “company”). The annual meeting will be held on Thursday, August 2, 2018, at 10:30
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