DOCSLIB.ORG

2017 Annual Report Jazz Pharmaceuticals Plc

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2017 Annual Report Jazz Pharmaceuticals Plc 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
Load more

Recommended publications
  • Final Attendee List
    Jennifer Abnet GlaxoSmithKline I GlaxoSmithKline I Jane Arboleda APRN Guardant I Molly Benson Sanjiv Agarwala MD Puma Biotechnology I Cancer Expert Now I Joe Arminger AbbVie I Seth Berkowitz LCSW, Manmeet Ahluwalia MD, CCLS MBA Patricia Armstrong The Leukemia & Lymphoma Miami Cancer Institute I Novartis I Society V Steve Albers Kim Arnold APRN CPNP Barry Berman MD, MS Alexion V CPHON Florida Cancer Specialists I Servier Pharmaceuticals I Maritza Alencar DNP, Tizano Bernard MBA, APRN, BMTCN Sheila Arrington MSN, Cancer Care Centers of Miami Cancer Institute V APRN, NP-C, AOCN Brevard I Puma Biotechnology I Carmen Allen MSIT Ana Mari Bernardini Pharmavoxx V Shannon Ashmon Novartis Oncology I Eisai, Inc I Luly Almeida Bernard Berry MBA Incyte Corporation I Sarah Ashton MS AstraZeneca Pharmaceuticals Guardant Health I I Talat Almukhtar MD Orlando Health Cancer Melissa Austin Jason Bever Institute I Cancer Care Centers of Oncopeptides I Brevard I Beatrice Alvarado Roberts Amy Bignon MD Garland Avera Doyle Caris Life Sciences I University of Florida I Jazz Pharmaceuticals I Nadeem Bilani MD Tadeu Ambros MD Francie Babcock Cleveland Clinic I FCS I AMAG Pharmaceuticals/Covis I Angela Bilik RN BSN Douglas Anderson AstraZeneca I Incyte Corporation I Craig Bailey Astra Zeneca I Jamie Bilsky BS Blesson Andrews Genentech V Genentech I Kevin Barr Daiichi Sankyo I Rohit Bishnoi MD Ollie Annum PharmD University of Florida I BHMCR I Leonard Bennett PharmD EMD Serono I Brady Blackman Susmitha Apuri MD MorphoSys I Florida Cancer Specialists I Michael Bennett As of 4-22-21 Kimberly Blandon RN MSN Rick Breitenstein Memorial Cancer Institute I Apellis Pharmaceuticals I Denise Capo Karyopharm Therapeutics I Taryn Boiteau GlaxoSmithKline I Amanda Bridges Florida Society of Clinical Heidi Caravetta Tracy Bonds RN, BSN, Oncology I Exelixis, Inc.
    [Show full text]
  • Q1 Pharma Sector Snapshot
    SPECIALTY & GENERIC PHARMA Q1 2021 Report Market Commentary – Debt Capital Markets Debt Markets ▪ 2020 saw increased amounts of debt used in buyouts across the board, resulting in the highest debt / EBITDA Median US Buyout Multiples levels since 2014 − The increased use of debt was driven by 2H20 back- end loaded lending activity (primarily 4Q20) as 16.0x 12.7x 14.1x 12.2x 12.0x 11.6x 11.5x certainty around the U.S. election and vaccination 11.1x 10.0x 9.8x 12.0x 9.7x expectations increased 9.4x 8.6x 8.3x 8.2x 7.5x 7.8x 5.2x 6.7x 5.7x 5.6x ▪ 8.0x 5.9x As the effects of COVID now begin to diminish, debt 5.4x 4.4x 4.1x 3.7x 4.6x 4.3x 3.8x markets have seemingly recovered, signaling that 3.6x lenders have become increasingly comfortable with 4.0x 4.3x 6.9x 6.5x 6.3x 6.0x 5.9x 5.7x 5.7x 5.7x 5.7x 5.6x 5.3x 4.5x 4.4x macroeconomic and company-specific fundamentals 4.3x 0.0x 3.2x − With increased confidence, lenders are currently looking to provide strong leverage for high-quality assets, particularly ones that have proven their Debt/EBITDA Equity/EBITDA EV/EBITDA stability through the recent market downturn Source: PitchBook ▪ The spread on U.S. high-yield debt has returned to pre- Historical US High Yield Debt Effective Yield COVID levels − 4.22% current effective yield compared with a 12.0% 11.4% 11.38% effective yield on March 23, 2020 (peak of the pandemic) 9.0% ▪ We expect increased activity by lenders in 2021 due to: 6.0% 4.2% − Pent-up demand in M&A activity driven by the impact of COVID 3.0% − Limited Partner agreements and investor
    [Show full text]
  • Perrigo Needs Deal to Thwart Mylan
    November 02, 2015 Perrigo needs deal to thwart Mylan Madeleine Armstrong Perrigo continues to resist Mylan’s overtures, but a deal is looking increasingly likely after its attempts to block the buy in court failed. Mylan has until November 13 to tempt Perrigo shareholders under Irish takeover rules. An acquisition of its own might now be the only hope for Perrigo in this buy-or-be-bought saga. But, with increasing consolidation in the speciality pharma space, the pool of potential targets is dwindling (see table below). The best option looks like Endo International, though its market cap of nearly $14bn might make it too big a bite for Perrigo, which has just $5bn in cash. But if Perrigo could pull it off it would gain a company with one of the best forecast growth rates in mid-tier pharma. Jazz Pharmaceuticals, Meda or Lundbeck could be easier to digest but the last, with faltering sales, might not be such an attractive proposition. Perrigo and its potential acquisition targets Company Based Market cap ($bn) 2014 sales ($m) 2020e sales ($m) CAGR Perrigo Ireland 23.1 815 1,388 +9% Endo International US 13.6 2,053 5,616 +18% Jazz Pharmaceuticals Ireland 8.4 1,163 2,151 +11 Lundbeck Denmark 5.9 2,222 1,974 -2% Meda Sweden 5.4 1,963 2,519 +4% Last line of defence Perrigo’s chief executive, Joseph Papa, is standing firm but the company’s share price closed down 5% at $157.74 on Friday, well off its 2015 high of $203.69 in April after Mylan formalised its bid (Mylan anti-chain action as good as confirms Teva interest, April 09, 2015).
    [Show full text]
  • Generic Pharma
    SPECIALTY/GENERIC PHARMA SECTOR SNAPSHOT April 2019 Branded Specialty Pharma – Transaction Comps USD in millions Announced Geographic Enterprise EV / EV / Date Target Target Description Buyer Location Value LTM Revenue LTM EBITDA LTM Revenue LTM EBITDA Specialty pharmaceutical company focused in hospital InvaGen Nov-18 Avenue Therapeutics USA $210.2 NA NA NA NA products Pharmaceuticals Specialty pharmaceutical company focused in Oct-18 Corium International Gurnet Point Capital USA $492.5 $36.5 ($44.0) 13.5x NM transdermal and transmucosal products NextWave Specialty pharmaceutical company focused in Sep-18 Tris Pharma USA NA NA NA NA NA Pharmaceuticals pediatric CNS products Specialty pharmaceutical company focused in opioid Aug-18 Adapt Pharma Emergent BioSolutions Ireland $719.8 NA NA NA NA abuse products Sylvant from Johnson & Branded product for the treatment of Casteleman's Jul-18 EUSA Pharma Ireland $115.0 NA NA NA NA Johnson disease Femring in US from May-18 Branded women's health products Millicent Pharma USA $75.0 $23.0 $17.0 3.3x 4.4x Allergan Pancreaze from Johnson & Branded pancreatice enzyme replacement therapy May-18 VIVUS USA $135.0 $35.2 -- 3.8x -- Johnson product Specialty pharmaceutical company with focus across May-18 Willow Biopharma VIVUS Canada NA NA NA NA NA various therapeutic areas Large pharmaceuctical company with products across Apr-18 Shire Takeda Pharmaceutical Ireland $80,535.0 $15,354.0 $6,449.9 5.2x 12.5x a range of therapeutic areas and geographies Specialty pharmaceutical company focused on Feb-18 Altius
    [Show full text]
  • Management Team
    Management Team Bruce C. Cozadd Executive Chairman Bruce Cozadd joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Mr. Cozadd served as a consultant to companies in the biopharmaceutical industry. From 1991 until 2001, he held various positions with ALZA Corporation, a pharmaceutical company now owned by Johnson & Johnson, most recently as its Executive Vice President and Chief Operating Officer, with responsibility for research and development, manufacturing and sales and marketing. Previously at ALZA Corporation he held the roles of Chief Financial Officer and Vice President, Corporate Planning and Analysis. Mr. Cozadd received a B.S. from Yale University and an M.B.A. from the Stanford Graduate School of Business. Mr. Cozadd serves on the boards of Cerus Corporation, a biopharmaceutical company; Threshold Pharmaceuticals, a biotechnology company; and The Nueva School and Stanford Hospital and Clinics, both non-profit organizations. Samuel R. Saks, MD Chief Executive Officer Samuel Saks, M.D., joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Dr. Saks was Company Group Chairman of ALZA Corporation and served as a member of the Johnson & Johnson Pharmaceutical Group Operating Committee. From 1992 until 2001, he held various positions with ALZA Corporation, most recently as its Chief Medical Officer and Group Vice President, where he was responsible for clinical and commercial activities. Dr. Saks received a B.S. and an M.D. from the University of Illinois. Dr. Saks serves on the board of Trubion Pharmaceuticals and Cougar Biotechnology. Robert M. Myers President Robert Myers joined Jazz Pharmaceuticals at its inception and was appointed as Jazz Pharmaceuticals’ President in March 2007.
    [Show full text]
  • Medicaid System (Mmis) Illinois Department of Run Date: 08/08/2015 Provider Subsystem Healthcare and Family Services Run Time: 21:25:58 Report Id 2794D052 Page: 01
    MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 08/08/2015 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 21:25:58 REPORT ID 2794D052 PAGE: 01 ALPHA COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 10/01/2015 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 68782 (OSI) EYETECH 65162 AMNEAL PHARMACEUTICALS LLC 00074 ABBOTT LABORATORIES 69238 AMNEAL PHARMACEUTICALS, LLC 68817 ABRAXIS BIOSCIENCE, LLC 53150 AMNEAL-AGILA, LLC 16729 ACCORD HEALTHCARE INCORPORATED 00548 AMPHASTAR PHARMACEUTICALS, INC. 42192 ACELLA PHARMACEUTICALS, LLC 66780 AMYLIN PHARMACEUTICALS, INC. 10144 ACORDA THERAPEUTICS, INC. 55724 ANACOR PHARMACEUTICALS 00472 ACTAVIS 10370 ANCHEN PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 62559 ANIP ACQUISITION COMPANY 45963 ACTAVIS INC. 54436 ANTARES PHARMA, INC. 46987 ACTAVIS KADIAN LLC 52609 APO-PHARMA USA, INC. 49687 ACTAVIS KADIAN LLC 60505 APOTEX CORP. 14550 ACTAVIS PHARMA MFGING PRIVATE LIMITED 63323 APP PHARMACEUTICALS, LLC. 67767 ACTAVIS SOUTH ATLANTIC 42865 APTALIS PHARMA US, INC 66215 ACTELION PHARMACEUTICALS U.S., INC. 58914 APTALIS PHARMA US, INC. 52244 ACTIENT PHARMACEUTICALS 13310 AR SCIENTIFIC, INC. 75989 ACTON PHARMACEUTICALS 08221 ARBOR PHARM IRELAND LIMITED 76431 AEGERION PHARMACEUTICALS, INC. 60631 ARBOR PHARMACEUTICALS IRELAND LIMITED 50102 AFAXYS, INC. 24338 ARBOR PHARMACEUTICALS, INC. 10572 AFFORDABLE PHARMACEUTICALS, LLC 59923 AREVA PHARMACEUTICALS 27241 AJANTA PHARMA LIMITED 76189 ARIAD PHARMACEUTICALS, INC. 17478 AKORN INC 24486 ARISTOS PHARMACEUTICALS, INC. 24090 AKRIMAX PHARMACEUTICALS LLC 67877 ASCEND LABORATORIES, L.L.C. 68220 ALAVEN PHARMACEUTICAL, LLC 76388 ASPEN GLOBAL INC. 00065 ALCON LABORATORIES, INC. 51248 ASTELLAS 00998 ALCON LABORATORIES, INC. 00469 ASTELLAS PHARMA US, INC. 25682 ALEXION PHARMACEUTICALS 00186 ASTRAZENECA LP 68611 ALIMERA SCIENCES, INC.
    [Show full text]
  • Current Sustaining Member Companies
    CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2020 D2 Pharma Consulting, LLC 1989 J & J Health Care Systems, Inc. 2011 Remund Group, LLC 1985 Abbott Laboratories, Inc. 2007 Daiichi Sankyo, Inc. 2014 Jazz Pharmaceuticals Inc. 2018 Rigel Pharmaceuticals 2013 AbbVie Inc. 2020 Deciphera Pharmaceuticals, LLC 2007 Karl Storz Endoscopy America 2000 Sanofi 2021 Adaptive Biotechnologies 2009 Deloitte 2021 Lantheus Holdings 2020 Seattle Genetics 2017 ACADIA Pharmaceuticals, Inc. 2020 Dexcom, Inc. 2020 Lipogems 2004 Siemens Medical Solutions 2020 AcelRx Pharmaceuticals, Inc. 2020 Drip Drop Hydration 2010 LLC Federal Solutions 2019 SK Life Science, Inc. 2020 Acorda Therapeutics 2017 Eagle Pharmaceuticals, Inc. 2014 Lovell Government Services LLC 2002 Smith & Nephew, Inc. 2019 Aimmune 2005 Eisai, Inc. 2021 Mainstay Medical 2019 Sobi Inc. 2003 Alcon Laboratories, Inc. 2019 electroCore, Inc. 2014 Mallinckrodt Pharmaceuticals 2013 Stryker Orthopaedics 2019 Alexion Pharmaceuticals, Inc. 2010 Endo Pharmaceuticals 2020 MannKind Corporation 2018 Sun Pharmaceutical 2017 Alkermes, Inc. 2017 Exelixis 1999 Marketing Assessment, Inc. 1999 Sunovion Pharmaceuticals, Inc. 2019 Alnylam Pharmaceuticals 2016 Express Scripts Federal Pharmacy 2009 Masimo Corporation 2016 Taiho Oncology, Inc. 2019 Altarum Institute 2010 Federal Practitioner 2019 Medical Strategies International, LLC 2015 Takeda Oncology 2020 Amarin Corporation 2021 Ferring Pharmaceuticals Inc. 2016 Melling Medical 2000 Takeda Pharmaceutical USA, Inc. 1994 AmerisourceBergen 2018 Foundation Medicine, Inc. 1954 Merck & Co., Inc. 2020 Telemynd 1992 Amgen 2021 Frontier Technology Inc. (FTI) 2002 MerzNorth America 2020 TerSera Therapeutics 2020 Amneal Pharmaceutical 2020 Fresenius Medical Care North America 2018 Mitsubishi Tanabe Pharma America 1990 Teva 2019 Aptive Resources LLC 1989 Genentech Inc.
    [Show full text]
  • Downloads That May Be Necessary
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 December 20, 2018 Date of Report (Date of earliest event reported) JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY (Exact name of registrant as specified in its charter) Ireland 001-33500 98-1032470 (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File No.) Identification No.) Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland (Address of principal executive offices, including zip code) 011-353-1-634-7800 (Registrant’s telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
    [Show full text]
  • Ligand Partner Jazz Pharmaceuticals Launches RYLAZE™ (Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn), Formerly JZP458
    July 21, 2021 Ligand Partner Jazz Pharmaceuticals Launches RYLAZE™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), Formerly JZP458 Ligand expects to receive $7 million in milestone payments Rylaze for the treatment of ALL or LBL utilizes Ligand’s Pelican Expression Technology™ Platform EMERYVILLE, Calif.--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has launched Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), also known as JZP458. Rylaze, which was approved by the FDA on June 30, 2021, is a recombinant erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli- derived asparaginase. Under the terms of the license agreement with Jazz Pharmaceuticals, Ligand received a $2 million payment upon FDA’s acceptance for review of the product BLA and is entitled to receive a $5 million payment upon the first commercial sale following launch. Ligand is eligible to receive up to an additional $155.5 million in milestone payments and tiered low to mid-single digit royalties based on worldwide net sales of any products resulting from this collaboration, including Rylaze. “This partnership with Jazz Pharmaceuticals is one of the core scientific programs that catalyzed our acquisition of Pfenex last year. The Rylaze commercial launch really showcases our highly productive partnership with Jazz and the exceptional ability of our Pelican Expression Technology to enable life-saving therapeutics,” said John Higgins, CEO of Ligand. “The robust manufacturing afforded by Ligand’s Pelican Expression Technology combined with Jazz’s demonstrated success in development and commercialization has enabled the delivery of a high-quality recombinant asparaginase option for patients with hypersensitivity to E.
    [Show full text]
  • Outcomes of Relapsed Or Refractory Acute Myeloid Leukemia After Frontline Hypomethylating Agent and Venetoclax Regimens
    Haematologica HAEMATOL/2020/252569 Version 4 Outcomes of relapsed or refractory acute myeloid leukemia after frontline hypomethylating agent and venetoclax regimens Abhishek Maiti, Caitlin R. Rausch, Jorge E. Cortes, Naveen Pemmaraju, Naval G. Daver, Farhad Ravandi, Guillermo Garcia-Manero, Gautam Borthakur, Kiran Naqvi, Maro Ohanian, Nicholas J. Short, Yesid Alvarado, Tapan M. Kadia, Koichi Takahashi, Musa Yilmaz, Nitin Jain, Steven Kornblau, Guillermo Montalban Bravo, Koji Sasaki, Michael Andreeff, Prithiviraj Bose, Alessandra Ferrajoli, Ghayas C. Issa, Elias J. Jabbour, Lucia Masarova, Philip A. Thompson, Sa Wang, Sergej Konoplev, Sherry A. Pierce, Jing Ning, Wei Qiao, John S. Welch, Hagop M. Kantarjian, Courtney D. DiNardo, and Marina Y. Konopleva Disclosures: AM: Research funding from Celgene Corporation CRR: None JEC: Research funding from Ambit BioSciences, ARIAD, Arog, Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Celator, Celgene, Novartis, Pfizer, Sanofi, Sun Pharma, Teva; consultant for Ambit BioSciences, ARIAD, Astellas Pharma, BiolineRx, Bristol-Myers Squibb, Novartis; Pfizer. NP: Consulting/honorarium: Celgene; Stemline; Incyte; Novartis; MustangBio; Roche Diagnostics, LFB; Research funding/clinical trials support: Stemline; Novartis; Abbvie; Samus; Cellectis; Plexxikon; Daiichi-Sankyo; Affymetrix; Grants/funding: Affymetrix, SagerStrong Foundation NGD: Sunesis Pharmaceuticals, Inc.: Consultancy, Research Funding; Karyopharm: Consultancy, Research Funding; Immunogen: Research Funding; Pfizer Inc.: Consultancy, Research
    [Show full text]
  • IHE Ishares US Pharmaceuticals ETF Gray Swan Event Factor For
    ETF Risk Report: IHE Buyer beware: Every ETF holds the full risk of its underlying equities Disclosures in the best interest of investors iShares US Pharmaceuticals ETF Gray Swan Event Risks exist for every equity held by IHE. Gray swan events include accounting fraud, management failures, failed internal controls, M&A problems, restatements, etc. These risks occur infrequently, but Gray Swan Event Factor for IHE 2.72% consistently for all equities. Equities account for 99.86% of IHE’s assets. Most investors ignore these risks until after they are disclosed; whereupon a stock’s price drops precipitously. Just as insurance companies can predict likely costs for a driver’s future car accidents based on the driver’s history, Watchdog Research contacts each ETF asking how they notify investors about we predict the likely cost (price drop) for IHE following accounting governance risks in equities in their fund. We will publish their response gray swan disclosures within its holdings. The expected when received. price decrease across the IHE equity portfolio is 2.72%. However, individual equity risks vary signicantly. This report helps investors know their risk exposure. Inception Date: 05/01/2020 Year-to-Date Return: -0.64% The iShares U.S. Pharmaceuticals ETF tracks the investment results of the Dow Jones U.S. Select Net Assets: $355m 1-Year Return: 33.74% Pharmaceuticals Index, composed of U.S. equities in the pharmaceuticals sector. The Fund uses a passive or Price: $177.65 3-Year Return: 7.84% indexing approach and invests by sampling the Index, Net Asset Value (NAV): $177.38 5-Year Return: 6.78% holding a collection of securities that approximates the full Index in key investment characteristics (such as Net Expense Ratio: 0.42% Yield: 1.23% market capitalization and industry weightings), fundamentals (such as return variability and yield), and As of: 03/31/2021 liquidity.
    [Show full text]
  • Fact Sheet As of 06/30/2021
    iShares U.S. Pharmaceuticals ETF IHE Fact Sheet as of 06/30/2021 The iShares U.S. Pharmaceuticals ETF seeks to track the investment results of an index composed of U.S. equities in the pharmaceuticals sector. KEY FACTS Fund Launch Date 05/01/2006 Expense Ratio 0.42% WHY IHE? Benchmark Dow Jones U.S. Select 1 Exposure to U.S. companies that manufacture prescription or over-the-counter Pharmaceuticals Index drugs or vaccines 30 Day SEC Yield 1.38% 2 Targeted access to domestic pharmaceutical stocks Number of Holdings 47 Net Assets $380,501,356 3 Use to express a sector view Ticker IHE CUSIP 464288836 GROWTH OF 10,000 USD SINCE INCEPTION Exchange NYSE Arca TOP HOLDINGS (%) JOHNSON & JOHNSON 22.43 PFIZER INC 18.04 ZOETIS INC CLASS A 4.76 MERCK & CO INC 4.74 ELANCO ANIMAL HEALTH INC 4.61 BRISTOL MYERS SQUIBB 4.61 ELI LILLY 4.58 CATALENT INC 4.54 JAZZ PHARMACEUTICALS PLC 4.20 Fund Benchmark VIATRIS INC 4.17 The Growth of $10,000 chart reflects a hypothetical $10,000 investment and assumes 76.68 reinvestment of dividends and capital gains. Fund expenses, including management fees and Holdings are subject to change. other expenses were deducted. PERFORMANCE 1 Year 3 Year 5 Year 10 Year Since Inception NAV 22.49% 8.57% 6.52% 11.28% 10.59% Market Price 22.69% 8.61% 6.55% 11.29% 10.59% Benchmark 22.94% 8.92% 6.82% 11.64% 11.01% The performance quoted represents past performance and does not guarantee future results.
    [Show full text]