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Vedanta Limited today announced its audited consolidated results under IndAS for the fourth quarter (Q4) and full year ended ended 31 March 2017 (FY 2017). Navin Agarwal, Chairman Vedanta Limited, said, "The completion of the Cairn India merger transforms Vedanta Ltd. into a diversified natural resources powerhouse, anchored in India. The combined entity truly reflects our strong, diversified, low-cost  portfolio with industry-leading volume growth from our well-invested assets.  Vedanta is one of the largest contributors to the exchequer in FY 2017, at c. Rs. 40,000 crore. The record dividends during the past financial year highlights our commitment to shareholder value. We are looking forward to a very exciting FY 2018 and future years, with all our businesses operating at full capacities and cost efficiencies." Tom Albanese, Chief Executive Officer, Vedanta Ltd, said: "I am happy to report that Vedanta has posted strong financial and operational results in FY2016-17. Our strategic focus to ramp up production across the portfolio namely in Zinc, Aluminium, Power and Iron Ore businesses throughout the year, has supplemented revenue growth. In particular, record production levels at Zinc and Aluminium were well-timed in an environment of strong supply side pressures on both commodities. Our cost management initiatives have helped us deliver strong returns for all our shareholders." 1.        Excludes custom smelting at Copper India and Zinc India operations 2.        Exceptional Items Gross of Tax Note:  All numbers are as per Ind AS. Previous period figures have been regrouped / rearranged wherever necessary to conform to current period presentation. Revenue in Q4 was up 16% sequentially and 41% y-o-y, driven by higher volumes from Zinc India, supported by ramp-up at the Aluminium and Power business and improved metal & oil prices. Additionally, higher volumes at Iron Ore in Q4 FY 2017 over Q4 FY 2016 aided higher revenues. Revenues for FY 17 were at Rs. 71,721 crore up 12% y-o-y. The increase was driven by ramp-up of capacities at Aluminium & Power business; recommencement of operations at Iron Ore and improved commodity prices. EBITDA in Q4 at Rs. 7,275 crore was 22% higher q-o-q, due to higher volumes from Zinc India & Aluminium business, cost efficiencies and improved metal and oil prices. EBITDA in Q4 was up 109% y-o-y on account of increased volumes at Iron Ore & Zinc India; ramp up of volumes & cost efficiencies at the Aluminium and Power business, improved commodity prices and decline in discount to Brent in the Oil & Gas business. This was partly offset by lower volume at Zinc International on account of Lisheen Mine closure in FY 2016 and natural decline at the Ravva and Cambay oil fields. EBITDA margin was robust at 44% in the current quarter, ~5% higher margin than Q3 on the back of continued strong operational performance, cost saving initiatives and improved metal and oil prices. EBITDA for the year was Rs. 21,437 crore up 41% on account of volume ramp-up at Aluminium & Power; recommencement of operations at Iron Ore; cost efficiencies across businesses and improved commodity prices. Depreciation & Amortization for Q4 at Rs.1,604 crore, was marginally higher by Rs. 23 crore compared to Q3 mainly on account of higher amortization of mining expenses owing to higher ore excavation at Zinc India and capitalization of new capacity at the Aluminium business partially offset by lower depreciation charge at Oil & Gas due to change in reserves estimates. However on y-o-y basis, it was lower by Rs. 478 crore. This was mainly on account of lower amortization charge post impairment of Oil & Gas assets in FY 2016 and lower depreciation charge at Oil & Gas business due to lower entitlement interest volume and an increase in entitlement reserves, partially offset by higher amortization of mining expenses owing to higher ore excavation at Zinc India and higher depreciation due to capitalization of new capacities at the Aluminium and Power businesses. Further, Depreciation & Amortization for the year was 6,292 crore compared to 8,572 crore in FY 2016. This was mainly on account of lower amortization charge post impairment of Oil & Gas assets in FY 2016 and lower depreciation charges at Oil & Gas business due to lower entitlement interest volume and an increase in reserves estimates and at Zinc International due to Lisheen mine closure. These were partially offset by higher amortization of mining expenses owing to higher ore excavation at Zinc India and capitalization of new capacities at the Aluminium and Power businesses. Finance cost during the quarter was Rs. 1,503 crore in line with Q3 due to marginal benefits from lower interest rates on short term borrowings being offset by capitalisation of new capacity at Aluminium business. On y-o-y basis, it was lower by Rs. 59 crore y-o-y. Decrease in finance cost on account of capitalization of interest pertaining to aluminium capacities under ramp up at Jharsuguda-II smelter (this was earlier being expensed when project start-up was temporarily on hold) & benefit due to lower interest rates on short term borrowings partially offset by increase in finance cost on account of capitalization of Aluminium & Power capacities. Further, finance cost during FY 2017 was Rs. 5,855 crore higher by Rs. 77 crore y-o-y. Increase in finance cost was due to capitalization and increase in borrowings at the Aluminium and power businesses; change in borrowing mix from USD to INR debt partially offset by the accounting treatment of interest at Jharsuguda-II smelter (which was earlier completely expensed when the project start-up was temporarily on hold and is now being capitalized as and when aluminium capacities are ramped up) and interest rate reduction on short term borrowings. Other income in Q4 at Rs. 921 crore was lower by 9% compared to Q3, mainly due to lower mark-to-market gains on investments in the current quarter and lower rate of return on investments. On a y-o-y basis, it was lower by 30% due to lower investment corpus at Zinc India on account of special dividend pay-out at the beginning of the year and lower mark-to-market gains on investments. On full year basis, it was higher than FY 16 by Rs 137 Crore driven by higher mark-to-market gains partly offset by lower investment corpus at Zinc India on account of special dividend pay-out. Exceptional Items in FY 2017 of Rs 114 Crore is primarily relating to write off on exploratory assets. Exceptional items in FY 2016 primarily include impairment in Oil & Gas business. Tax expense (before Exceptional items & DDT) was at Rs. 636 crore during the quarter, resulting in tax rate of 12%. The tax rate in Q3 FY2017 was at 14%. The reduction in tax rate is on account of currency appreciation resulting in deferred tax reversal in current quarter. Tax expense (before Exceptional items & DDT) for the year FY 2017 was at Rs. 2,103 crore, implying an effective tax rate of 15% compared to Rs 70 Crore and a tax rate of 1% in FY 2016. Effective tax rate at Zinc India and Oil & Gas was higher due to phasing out of tax holiday benefits. Attributable Profit After Tax (PAT) and Earnings Per Share (EPS) Attributable PAT before exceptional items and DDT for the quarter at Rs. 2,971 crore is up 3.4 times. Attributable PAT before exceptional items and DDT for the year at Rs.7,323 crore is 2.6 times higher compared to last year mainly on account of  higher EBITDA and lower depreciation. EPS for the year before exceptional items and DDT was at Rs. 24.70 per share. The financial results of the Company have been prepared in accordance with the Indian Accounting Standards ("Ind AS") as prescribed under Section 133 of the Companies Act, 2013 read with relevant rules issued thereunder.  The date of transition to Ind AS is April 1, 2015. The Company had previously issued its unaudited financial results for periods through December 31, 2016, prepared in accordance with the recognition and measurement principles of IND-AS, based on its preliminary selection of exemptions and accounting policies. Since all such policies and exemptions have now been finalised, financial results for all periods from April 1, 2015 have now been restated to give effect of the same. Our financial position remains strong with cash and liquid investments of Rs. 63,471 crore. The Company follows a Board approved investment policy and invests in high quality debt instruments with the mutual funds, bonds and fixed deposits with banks. The portfolio is rated by CRISIL which has assigned a rating of "Very Good" (meaning Highest Safety) to our portfolio. Further, the Company has undrawn committed facilities of $0.9bn as on March 31, 2017. As on 31st March 2017, gross debt was at Rs 71,569 Cr including short term borrowing of Rs. 7,908 Cr borrowed by Zinc India due to mismatch between Investment maturities and dividend payment. Excluding Zinc India temporary borrowing, gross debt decreased  by  Rs. 4,115 crore to Rs. 63,661crore. Net debt reduced by Rs. 3,415 crore during the quarter to Rs. 8,099 crore on account of positive free cash flow during the quarter. Out of the total debt of Rs. 71,569 crore, the INR/USD split is approximately 86%/ 14%. Further, the gross debt comprises of 63% long term loans and INR Bonds and 37% short term loans. The merger of Vedanta Limited with Cairn is now complete. The Cairn shares have been delisted from the Stock Exchanges and Vedanta Limited shares have been issued to Cairn shareholders. The Board has approved a dividend policy for the company. An extract of the approved dividend policy is below. The complete policy is available on the website of the company at In every financial year, the Board aims to distribute to its equity shareholders: 1.1. The entire dividend income (net of taxes) it receives from its subsidiary, Hindustan Zinc Ltd. (this does not apply to any one-time special dividends received from Hindustan Zinc Ltd. which will be at the discretion of the Board); and 1.2. Minimum 30% (including taxes, cess, and levies, if any relating to the dividend) of Attributable Profit after Tax (before exceptional items) of the Company excluding its share of profits in Hindustan Zinc Ltd for the year. Such profits will be net of dividend payout to preference shareholders, if any. Please note that the results presentation is available in the Investor Relations section of the company website www.vedantalimited.com - http://www.vedantalimited.com/investor-relations/results-reports.aspx Following the announcement, there will be a conference call at 6:00 PM (IST) on Monday, 15 May 2017, where senior management will discuss the company's results and performance. The dial-in numbers for the call are as below: For further information, please contact: Vedanta Limited is a diversified natural resources company, whose business primarily involves producing oil & gas, zinc - lead - silver, copper, iron ore, aluminium and commercial power. The company has a presence across India, South Africa, Namibia, Australia and Ireland. Vedanta Limited is the Indian subsidiary of Vedanta Resources Plc, a London-listed company. Governance and Sustainable Development are at the core of Vedanta's strategy, with a strong focus on health, safety and environment and on enhancing the lives of local communities. The company is conferred with the Confederation of Indian Industry (CII) 'Sustainable Plus Platinum label', ranking among the top 10 most sustainable companies in India. To access the Vedanta Sustainable Development Report 2016, please visit http://sustainabledevelopment.vedantaresources.com/content/dam/vedanta/corporate/documents/Otherdocuments/SDreport2015-16/Vedanta%20SDR%20FY%2015-16.pdf Vedanta Limited is listed on the Bombay Stock Exchange and the National Stock Exchange in India and has ADRs listed on the New York Stock Exchange. For more information please visit www.vedantalimited.com This press release contains "forward-looking statements" – that is, statements related to future, not past, events. In this context, forward-looking statements often address our expected future business and financial performance, and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "should" or "will." Forward–looking statements by their nature address matters that are, to different degrees, uncertain. For us, uncertainties arise from the behaviour of financial and metals markets including the London Metal Exchange, fluctuations in interest and or exchange rates and metal prices; from future integration of acquired businesses; and from numerous other matters of national, regional and global scale, including those of a political, economic, business, competitive or regulatory nature. These uncertainties may cause our actual future results to be materially different that those expressed in our forward-looking statements. We do not undertake to update our forward-looking statements.


News Article | April 17, 2017
Site: en.prnasia.com

TOKYO, April 17, 2017 /PRNewswire/ -- Reed Exhibitions Japan will be holding the 26th edition of Japan IT Week Spring from May 10-12 at Tokyo Big Sight, Japan. The show is the largest annual business platform in Japan for IT professionals, covering various sectors of IT ranging from microprocessors to the latest applications. This year 91,000 professional visitors and 1,600 exhibitors will gather across 13 exhibitions; Software & Apps Development Expo (SODEC), Big Data Management Expo (BIG DATA Spring), Embedded Systems Expo (ESEC Spring), Data Storage Expo (DSE), Data Center Expo (DATA CENTER Spring), Information Security Expo (IST Spring), Web & Digital Marketing Expo (Web-Mo Spring), Cloud Computing Expo Japan (CLOUD JAPAN Spring), Mobile Solutions Expo (MOBIX Spring), IoT/M2M EXPO (IoT/M2M Spring), Direct Commerce Solutions Expo (DIREX Spring), Consumer IT Products Expo (C-PEX) and Store & Retail IT Solutions Expo (STOREX Spring). With the need for high quality products, the latest technology and international outsourcing increasing in the Japanese IT market, exhibitors joining 26th Japan IT Week Spring from overseas have been rising. Reflecting such trend, the percentage of international firms will be 1.3 fold higher and the overall scale will be expanding by more than 10%. New Exhibition for Store & Retail IT Solutions One of the highlights of this year's show will be the newly launching exhibition - Store & Retail IT Solutions Expo (STOREX Spring) to aid business between corporate professionals and firms looking to invest in the field of store and retail IT solutions. Exhibits will include Store Operations Solutions, Omni-Channel Retailing, POS Systems, Store Sales Promotion Solutions, and Customer Service Solutions. TSUBAKIMOTO CHAIN and DATAVAN INTERNATIONAL will be showcasing their latest terminals. The launch of STOREX Spring is one of the contributing factors for the show expansion and increasing overall participation. Since STOREX Spring is concurrently held with Direct Commerce Solutions Expo (DIREX Spring) and Web & Digital Marketing Expo (Web-Mo Spring), the show is expected to gather large quantity of visitors in hospitality industry. "IoT/M2M EXPO (IoT/M2M Spring)" had been serving as the platform for various chip manufacturers, firms with exhibits related to connective technologies and applications to negotiate business at 26th Japan IT Week Spring as the concept of IoT continues to spread and emerge new business. From devices, operators, solution providers to applications related to IoT and M2M, a wide range of firms will be exhibiting such as chip manufacturers including QUALCOMM, MURATA MANUFACTURING, wireless chip manufacturers such as TOKYO ELECTRON DEVICE, HITACHI, TELIT, U-BLOX, operators such as NTT DOCOMO, VODAFONE, KDDI and solution providers including MICROSOFT, ROBERT BOSCH, SORACOM will also be exhibiting. Special Session will be delivered at the conference held parallel to the exhibition where ROBERT BOSCH, SIEMENS, QUALCOMM and FANUC will explain newly generated market values, technical developments and essential next steps will be addressed. The 3 major Japanese operators DOCOMO, SOFTBANK and KDDI will also hold Special Sessions. With the expansion of IoT/M2M EXPO (IoT/M2M Spring), Embedded Systems Expo (ESEC Spring) is also growing as supporting technologies of IoT and M2M. Major firms exhibiting from Japan include MITSUBISHI, SONY, TOSHIBA, RICOH, CANON and from overseas INTEL, ADLINK, ADVANTECH, CONGATEC, TRANSCEND, BECKHOFF AUTOMATION, PHOENIX CONTACT etc. On the topic of embedded systems, DeNA and an expert from the UNIVERSITY OF TOKYO will be holding talks on autonomous driving technologies at the Keynote Session. With the rise in identity fraud, unauthorized access and cyber-attacks in Japan, information security is a major area of interest. The trending concept of IoT also inevitably addresses the need to direct attention towards security issues for connectivity. Major firms exhibiting include TREND MICRO, IBM, DOCOMO SYSTEMS, HITACHI SOLUTIONS, CANON IT SOLUTIONS, NTT SOFTWARE, KYOCERA, CYLANCE etc. will be showcasing various exhibits such as hacking preventions, DoS preventions, anti-virus solutions, internet intrusion protections, data delete/recovery, IT asset management products and services. At the Keynote for Information Security Expo (IST Spring), TREND MICRO will hold a talk on the current status and future of ICT security and SYMANTEC will speak on Cyber security of the Rio Olympic Games as an official security sponsor. MICROSOFT will also be discussing the role and responsibility of IT department inside firms regarding security strategies. To search for exhibitors and exhibit information: www.japan-it.jp/en/haru/eguide/ 26th Japan IT Week is Japan's largest trade show with established presence in Japanese IT industry and the show has been growing consistently attracting more and more IT professionals around the world. This year, the show is expecting to welcome 350 international exhibitors from 21 different countries with several national pavilions. The show truly serves as the best platform to connect with the latest IT solutions from all over the world. In addition to the must-see exhibition, 26th Japan IT Week Spring holds a total of 56 conference sessions conducted by globally renowned speakers in the industry such as IBM, MICROSOFT and QUALCOMM covering wide range of the latest topics. For details of the conference: www.japan-it.jp/en/Conference/Conference-Program/   Full program in Japanese: www.japan-it.jp/haru/seminar/ 26th Japan IT Week Spring is inarguably a must-attend show that provides solutions for all global IT experts. Free visitor registration can be made online for free at: www.japan-it.jp/en/haru/inv/ For IT professionals with job titles above manager, VIP visitor registrations with privileges can be made online at: www.japan-it.jp/en/haru/vip/ For more information about 26th Japan IT Week Spring, visit the official website: www.japan-it.jp/en/haru/


MELVILLE, N.Y.--(BUSINESS WIRE)--Verint® Systems Inc. (Nasdaq: VRNT) today announced its participation in various speaking engagements and industry events taking place this month. CX Sydney 2017 May 9; Sydney, Australia Martyn Riddle, APAC marketing director, will serve as a panelist during the “Customer-Obsessed Game Changers” session at 2:50 pm AEST. Attendees of this Forrester event will hear from a group of digital customer experience (CX) leaders about how traditional enterprises can challenge conventional notions of commerce and CX; how cultures and organizations need to adapt to the digital economy; and how marketers and technologists need to collaborate to define brands and delight customers. Korea Channel & Communication Management Conference May 17; Seoul, South Korea Craig Seebach, VP, enterprise workforce optimization, will take part in the session “Creating a Customer Engagement Culture by Focusing on Workforce Optimization and Employee Engagement” at 10:40 am KST. Attendees will learn how WFO and employee engagement solutions are directly impacting both customer experiences and loyalty. CXPA Insight Exchange 2017 May 16-17; Phoenix, Arizona Raj Sivasubramanian, director, customer experience services, will present “Is Your Omnichannel Strategy Customer-Centric or Self-Centric?” on May 17 at 11 am ET. Many organizations have invested significant resources and time in omnichannel strategies. This session will explore how these strategies can equally benefit both companies and their customers and the role seamless communications across online and offline channels plays. Verint Engage: Global Customer Conference 2017 May 22-25; Orlando, Florida Customers from around the world will convene for this annual event that highlights customer success, market trends, technology innovation, customer experience insights and best practices for maximizing customer and employee engagement. Verint will be joined by a prestigious group of industry analysts, customers and thought leaders, who will explore how contact center, CX, branch and back-office operations, government and public sector, and marketing and digital professionals are achieving their goals, meeting and exceeding expectations, and excelling in today’s omnichannel sales, service and marketing environments. Find out more by clicking here. Digital Transformation India 2017 May 30; Mumbai, India Also speaking to the topic of “Customer-Obsessed Game Changers” will be Verint’s Anil Chawla, India country manager. During this regional Forrester event, Chawla will serve as a panel presenter at 3:50 pm IST during this one-day digital transformation event focused on “leading the digital enterprise for innovation and growth.” About Verint Systems Inc. Verint® (Nasdaq: VRNT) is a global leader in Actionable Intelligence® solutions with a focus on customer engagement optimization, security intelligence, and fraud, risk and compliance. Today, more than 10,000 organizations in approximately 180 countries—including over 80 percent of the Fortune 100—count on intelligence from Verint solutions to make more informed, effective and timely decisions. Learn more about how we’re creating A Smarter World with Actionable Intelligence® at www.verint.com. This press release contains "forward-looking statements," including statements regarding expectations, predictions, views, opportunities, plans, strategies, beliefs, and statements of similar effect relating to Verint Systems Inc. These forward-looking statements are not guarantees of future performance and they are based on management's expectations that involve a number of risks, uncertainties and assumptions, any of which could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. For a detailed discussion of these risk factors, see our Annual Report on Form 10-K for the fiscal year ended January 31, 2017 and other filings we make with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release and, except as required by law, Verint assumes no obligation to update or revise them or to provide reasons why actual results may differ. VERINT, ACTIONABLE INTELLIGENCE, MAKE BIG DATA ACTIONABLE, CUSTOMER-INSPIRED EXCELLENCE, INTELLIGENCE IN ACTION, IMPACT 360, WITNESS, VERINT VERIFIED, KANA, LAGAN, VOVICI, GMT, VICTRIO, AUDIOLOG, CONTACT SOLUTIONS, OPINIONLAB, ADTECH, CUSTOMER ENGAGEMENT SOLUTIONS, CYBER INTELLIGENCE SOLUTIONS, VOICE OF THE CUSTOMER ANALYTICS, NEXTIVA, EDGEVR, RELIANT, VANTAGE, STAR-GATE, ENGAGE, CYBERVISION, FOCALINFO, SUNTECH, and VIGIA are trademarks or registered trademarks of Verint Systems Inc. or its subsidiaries. Other trademarks mentioned are the property of their respective owners.


-- Increased Investment in its Rapidly Growing Orphan Biologic Medicine for Refractory Chronic Gout, KRYSTEXXA® -- -- Raising KRYSTEXXA Peak Annual Net Sales Estimate to More than $400 Million from More than $250 Million -- -- Announces Acquisition of River Vision Development Corp. and Teprotumumab, a Biologic in Late-Stage Development for a Rare Eye Disease -- -- Revising Full-Year 2017 Net Sales Guidance Range to $1.000 Billion to $1.035 Billion and Full-Year 2017 Adjusted EBITDA Guidance Range to $315 Million to $350 Million; Reflects Revisions to the Primary Care Business Unit Assumptions, Increased Investment in KRYSTEXXA and R&D Investment in Teprotumumab -- -- Announces Board of Directors’ Authorization of Share Repurchase Program for Approximately 10 Percent of Shares Outstanding -- DUBLIN, Ireland, May 08, 2017 (GLOBE NEWSWIRE) -- Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced its first-quarter 2017 financial results today and revised its full-year 2017 net sales and adjusted EBITDA guidance. “We generated strong first-quarter performance in our orphan and rheumatology business units, with KRYSTEXXA and RAVICTI achieving record net sales; however, our primary care business unit performed well below our expectations,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.  “The lower primary care business unit results were related to the implementation of the contracting model with pharmacy benefit managers, which has not performed in accordance with our expectations.  While we are proactively addressing this underperformance, with greater visibility into the impact of this transition, we are revising our full-year 2017 net sales and adjusted EBITDA guidance.” Mr. Walbert added, “We have transformed Horizon Pharma into a company focused on rare disease medicines and we are significantly increasing our investment in one of our key growth drivers, KRYSTEXXA, which we now believe can exceed $400 million in peak annual sales.  That investment is supported by our continued expectation of strong cash-flow generation for the year, which also allows us to continue to seek attractive acquisitions, such as River Vision, which we announced today.  These actions, in addition to our newly authorized share repurchase program, reflect our confidence in the long-term value of our Company.” • Orphan Business Unit:  First-quarter orphan business unit net sales increased 70 percent compared to the first quarter of 2016. RAVICTI net sales in the first quarter of 2017 were $43.9 million, an increase of 18 percent compared to the first quarter of 2016.  The Company expects RAVICTI to be launched in Europe later in 2017 in partnership with Swedish Orphan Biovitrum AB (SOBI). PROCYSBI net sales in the first quarter of 2017 were $34.3 million, up 25 percent compared to Raptor’s pre-acquisition net sales of $27.5 million in the first quarter of 2016, driven by continued strong patient demand from both patients converting from older-generation therapy as well as treatment-naïve patients. ACTIMMUNE net sales in the first quarter of 2017 were $26.2 million, an increase of 3 percent versus the first quarter of 2016.  The Company has evolved its strategy to establish the role of ACTIMMUNE in a broader range of chronic granulomatous disease patients and ACTIMMUNE remains on track to return to growth for the full-year 2017. The Company continues to make progress in the Phase 1 dose escalation trial evaluating ACTIMMUNE as part of a combination therapy in solid tumors for certain cancers.  In February, preliminary data presented at the American Society of Clinical Oncology Clinical Immuno-Oncology Symposium conference showed that combination therapy of ACTIMMUNE with nivolumab, a PD-1 inhibitor, was safe and well-tolerated in the first two cohorts.  The data also showed statistically significant activation of certain monocytes, or white blood cells in peripheral blood, which demonstrates that ACTIMMUNE is having the desired effect of stimulating immune cells.  These are early results, and the third cohort of patients is still under study.  In the first quarter of 2017, a fourth cohort was added to the study to more fully assess dose response.  In addition, a number of academic and clinical institutions have expressed interest in studying ACTIMMUNE as combination therapy in certain cancers, including the National Cancer Institute, which plans to initiate a study later this year to treat patients with Cutaneous T-Cell Lymphoma (CTCL) with ACTIMMUNE and pembrolizumab, a PD-1 inhibitor. The acquisition of River Vision provides the Company with teprotumumab, a fully human monoclonal antibody that targets Insulin-like Growth Factor-1 receptor (IGF-1R).  Teprotumumab is in late-stage development for TED, and has received Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA.  On May 4, 2017, The New England Journal of Medicine published teprotumumab Phase 2 study results that demonstrate significant clinical efficacy in TED.  Teprotumumab was also safe and well tolerated.  The Company expects to begin a Phase 3 pivotal program of teprotumumab in TED in the second half of 2017. • Rheumatology Business Unit:  KRYSTEXXA net sales in the first quarter of 2017 were $31.6 million, an increase of 96 percent compared to the first quarter of 2016.  Since acquiring the medicine in January of 2016, the Company’s improved commercial strategy and additional investment in commercial, education and outreach efforts has rapidly accelerated KRYSTEXXA net sales. Based on the continued increase in uptake of KRYSTEXXA and the clear unmet need that exists for thousands of refractory chronic gout sufferers, the Company will significantly increase its infrastructure and investment in the medicine.  Beginning in the second quarter and continuing through the second half of 2017, the Company will expand its commercial organization to nearly 200 employees from more than 100.  With the additional resources, the Company expects to expand its reach to physicians and increase awareness of refractory chronic gout among physicians and patients.  As a result, the Company now expects KRYSTEXXA annual peak net sales of more than $400 million versus the previous estimate of more than $250 million. • Primary Care Business Unit:  Total net sales for the primary care business unit were $65.6 million in the first quarter of 2017.  Net sales of PENNSAID 2%, DUEXIS and VIMOVO in the first quarter of 2017 were $41.6 million, $17.7 million and $4.9 million, respectively. During the second half of 2016, the Company entered into rebate agreements with pharmacy benefit managers (PBMs) in an effort to secure broader inclusion of its primary care medicines on healthcare plan formularies.  This transition to PBM rebate agreements, most of which became effective January 1, 2017, was a change to the commercial model of the Company’s primary care business unit, and following this transition, first-quarter 2017 primary care business unit net sales were lower than the Company’s expectations. Total prescription volumes for DUEXIS, VIMOVO and PENNSAID 2% were approximately in line with the Company’s expectations in the first quarter of 2017.  However, the average net realized price (ANRP) was significantly below expectations due to higher patient assistance costs and higher PBM rebate levels than anticipated.  This was a function of lower-than-anticipated adoption rates of the Company’s primary care medicines onto certain healthcare plan formularies (custom clients), resulting in higher patient assistance costs to the Company, as well as fact that PBM plans that covered the Company’s primary care medicines are primarily plans that require a higher rebate (PBM-chosen formulary clients), resulting in higher rebate costs.  To a lesser extent, the lower ANRP in the quarter was also due to a higher rate of managed care control in the Company’s non-contracted business, reflecting an industry-wide trend. PBM clients broadly fall into two categories, clients that follow a PBM-chosen formulary and clients where the PBM works on their behalf to provide customized formularies (custom clients).  Rebate amounts paid to the PBMs for custom clients are typically lower than rebate amounts paid to the PBM for PBM-chosen formulary clients. When the Company established its financial guidance for full-year 2017, the Company estimated the adoption trajectory and mix of PBM clients that the change to its commercial model would generate.  This took into account input from the PBMs.  The Company did not have full visibility into the actual PBM client mix and the magnitude of the difference compared to its assumptions until it received detailed PBM invoices in late April and early May. While the Company continues to work to drive adoption of its medicines with custom clients, it now expects a much lower level of adoption of custom client plans in 2017.  Compared to its previous financial guidance, the Company has incorporated a higher level of rebates, a higher level of patient assistance costs and a lower level of total prescription volume into its full-year 2017 primary care business unit net sales forecast.  It is also reducing certain primary care business unit operating costs as well as other company costs to align its cost structure with revised net sales expectations.  As a result, the Company has lowered its full-year 2017 net sales and adjusted EBITDA guidance. First-Quarter 2017 Financial Results Note:  For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release. For the full-year 2017, the Company expects continued strong net sales growth for both its orphan and rheumatology businesses, driven primarily by strong patient growth in KRYSTEXXA, RAVICTI and PROCYSBI.  In its primary care business unit, the Company is assuming net sales of more than $300 million. As a result of these expectations, the Company revised its full-year 2017 net sales guidance range to $1.000 billion to $1.035 billion from $1.240 billion to $1.290 billion.  The Company revised its full-year 2017 adjusted EBITDA guidance to $315 million to $350 million from $525 million to $575 million, which assumes the lower net sales range and accounts for cost reductions, primarily in its primary care business, and a reinvestment of a portion of these reductions in KRYSTEXXA to maximize its long-term potential.  It also reflects an approximate $20 million increase in operating expenses, primarily in R&D, for full-year 2017 related to teprotumumab.  The Company is raising its estimate of peak annual net sales for KRYSTEXXA to $400 million from $250 million. At 7:30 a.m. EST / 12:30 p.m. IST today, the Company will host a live conference call and webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed by visiting Horizon's website at http://ir.horizon-pharma.com.  Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the conference call will be available approximately two hours after the call and accessible through one of the following telephone numbers, using the passcode below: About Horizon Pharma plc Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs.  The Company markets 11 medicines through its orphan, rheumatology and primary care business units.  For more information, please visit www.horizonpharma.com.  Follow @HZNPplc on Twitter or view careers on our LinkedIn page. Note Regarding Use of Non-GAAP Financial Measures EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon Pharma as non-GAAP financial measures.  Horizon Pharma provides certain other financial measures such as non-GAAP net income, non-GAAP diluted earnings per share, non-GAAP gross profit and gross profit ratio, non-GAAP operating expenses, non-GAAP tax rate and non-GAAP operating cash flow, each of which include adjustments to GAAP figures.  These non-GAAP measures are intended to provide additional information on Horizon Pharma’s performance, operations, expenses, profitability and cash flows.  Adjustments to Horizon Pharma's GAAP figures as well as EBITDA exclude acquisition-related expenses, charges related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia, an upfront fee for a license of a patent, a litigation settlement, loss on debt extinguishment and loss on sale of long-term investments, costs of debt refinancing, drug manufacturing harmonization costs, as well as non-cash items such as share-based compensation, depreciation and amortization, royalty accretion, non-cash interest expense, intangible and other non-current asset impairment charges, and other non-cash adjustments.  Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred.  Horizon maintains an established non-GAAP cost policy that guides the determination of what costs will be excluded in non-GAAP measures.  Horizon Pharma believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon Pharma's financial and operating performance.  The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected 2017 financial results and trends and to facilitate comparisons between periods and with respect to projected information.  In addition, these non-GAAP financial measures are among the indicators Horizon Pharma's management uses for planning and forecasting purposes and measuring the Company's performance.  For example, adjusted EBITDA is used by Horizon Pharma as one measure of management performance under certain incentive compensation arrangements.  These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.  Horizon Pharma has not provided a reconciliation of its full-year 2017 adjusted EBITDA outlook to an expected net income (loss) outlook because certain items such as acquisition-related expenses and share-based compensation that are a component of net income (loss) cannot be reasonably projected due to the significant impact of changes in Horizon Pharma's stock price, the variability associated with the size or timing of acquisitions and other factors.  These components of net income (loss) could significantly impact Horizon Pharma’s actual net income (loss). Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to Horizon Pharma's full-year 2017 net sales and adjusted EBITDA guidance, expected peak annual sales of KRYSEXXA, growth of 2017 ACTIMMUNE net sales and 2017 nets sales of Horizon Pharma’s primary care business unit medicines, expected financial performance in future periods, expected timing of clinical, regulatory and commercial events, including the planned Phase 3 pivotal clinical trial of teprotumumab and anticipated additional clinical trials of ACTIMMUNE in cancer indications, the timing and potential benefits of Horizon Pharma’s acquisition of River Vision, planned reductions in the Company’s primary care operating expenses and increases in R&D investment and KRYSTEXXA commercialization spending, the expected future impact of Horizon Pharma’s primary care business unit PBM contracting commercial model, the expected launch of RAVICTI in Europe, potential market opportunity for Horizon Pharma’s medicines in approved and potential additional indications, potential growth of Horizon Pharma’s medicines and business and other statements that are not historical facts.  These forward-looking statements are based on Horizon Pharma's current expectations and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon Pharma’s actual future financial and operating results may differ from its expectations or goals; Horizon Pharma’s ability to grow net sales from existing products; the availability of coverage and adequate reimbursement and pricing from government and third-party payers and risks relating to Horizon Pharma’s ability to successfully implement its business strategies; whether Horizon Pharma is able to realize expected benefits from arrangements with PBMs; risks related to acquisition integration and achieving projected benefits; risks associated with clinical development and regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon Pharma operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon Pharma's filings and reports with the SEC.  Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information.


Working for the world's largest Insurance & Banking companies, IBaseIT has quickly understood the need to adopt Robotic Process Automation and incorporate it to their business model. "We have faced situations where developing innovative software was just one part of the puzzle. The need to adopt innovation strategically is increasingly becoming a demanding requirement and transformation cannot happen in silos. The absolute next step towards digital transformation is RPA," commented Ram Yerneni, CEO from IBaseIT. "It is an undeniable fact that RPA has evolved into a strategic decision rather than a tactical one. As we are expanding in India, we see this becoming a huge trend and we have opened up a partnership program to facilitate professional services in addition to our new office in India that will be opening by the end of May, 2017." said Marios Stavropoulos, CEO at Softomotive. Balaji Hariharan, the newly appointed Managing Director, Softomotive India, stated "I am excited to look out for more business opportunities for Robotic Process Automation in India & Asia- pacific. Our new entity in India enhances our capability to serve existing and potential clients with premium Implementation and Support services". Balaji will be managing the Softomotive India office, located in Block 6A,1st Floor, RMZ Ecoworld, Bellandur Bangalore Karnataka 560103. Contact Softomotive. Softomotive, together with IBaseIT, are partnering to offer strong Quality Orientation and Cross-Technology expertise combined with distributed project management capabilities, thus guaranteeing successful on-time and on-budget project completion. Leveraging ProcessRobot, Softomotive's Robotic Process Automation solution, IBaseIT will empower enterprises to dramatically reduce operational costs, increase efficiency, improve productivity and accelerate performance. Softomotive's RPA platform will be demoed on Thursday, May 25 at 6.30 IST. Interested parties are able to register here for this live product webcast demonstration. With the right mix of technical expertise and business domain knowledge, both companies are determined to empower digital transformation - from Software Development and Product Lifecycle Management to Business Strategy and RPA implementation.


News Article | May 26, 2017
Site: www.eurekalert.org

The world's highest gain high power laser amplifier - by many orders of magnitude - has been developed in research led at the University of Strathclyde. The researchers demonstrated the feasibility of using plasma to amplify short laser pulses of picojoule-level energy up to 100 millijoules, which is a 'gain' or amplification of more than eight orders of magnitude - which could be likened to amplifying the sound of rustling leaves to that of a jumbo jet - in only two mm of plasma. They used 150 J pulses from the powerful Vulcan laser system at the Science and Technology Facilities Council's Central Laser Facility (CLF). Over the course of two pioneering experiments at the CLF, the scientists worked closely with CLF staff to adapt the Vulcan laser in order that two different colour lasers could exchange energy in a plasma. The measured gain coefficient of 180 cm-1 is more than 100 times larger than achievable from existing high power laser system amplifiers based on solid-state media. The results have been published in the journal Scientific Reports, in an article entitled An ultra-high gain and efficient amplifier based on Raman amplification in plasma. Professor Dino Jaroszynski, of Strathclyde's Department of Physics, led the research. He said: "Raman amplification in plasma is a fascinating concept that combines the ideas of Nobel Physics laureate CV Raman with plasma, optical and laser physics. Here, a relatively long, high-energy laser pulse is made to collide in plasma with a short, very low energy pulse. At the point where they collide they produce a beat wave, much like that of two colliding water waves. The light pressure of the beat pattern drives plasma electrons into a regular pattern or echelon that mimics the beat wave. This multi-layer echelon acts as a very high reflectivity, time-varying mirror that sweeps up the energy of the high energy pulse reflecting it into the low energy pulse, thus amplifying the low energy pulse and compressing its energy into an ultra-short duration pulse of light. "Our results are very significant in that they demonstrate the flexibility of the plasma medium as a very high gain amplifier medium. We also show that the efficiency of the amplifier can be quite large, at least 10%, which is unprecedented and can be increased further. However, it also shows what still needs to be understood and controlled in order to achieve a single stage high-gain, high-efficiency amplifier module. "One example of the challenges that we still face is how to deal with amplification of 'noise' produced by random plasma fluctuations, which is exacerbated by the extremely high gain. This leads to undesirable channels for the energy to go. We are making excellent progress and believe that we are in an excellent position to solve these problems in our next experimental campaigns." Dr Gregory Vieux who led the research team working at the CLF, said: "Plasma is a very attractive medium to work with. It has no damage threshold since it is already a fully broken-down medium, therefore we can use it to amplify short laser pulses without the need for stretching and re-compressing. Another advantage is that further compression during the amplification is theoretically possible. This could pave the way for the development of the next generation of laser systems delivering ultra-intense and ultra-short pulses and at a fraction of the cost of existing lasers. "Still, we are not quite there yet. The scheme relies on controlling the Raman instability. It has such a large growth factor that it can develop and grow from small plasma fluctuations." Laser amplifiers are devices that amplify light. In those that are familiar to us, this is done by synchronising the light emission from electrons in atoms or solid state matter, to make it coherent, which is a necessary step to achieving very high powers. However, very high power lasers at the frontier of technology are limited by damage to their optical components and amplifying media. This makes them very large and very expensive. Plasma, the ubiquitous medium of the universe, offers a way around this limitation because it is very robust and resistant to damage - plasma can be seen as matter that has already been broken down into its smallest constituent elements: electrons and ions. By harnessing waves in plasma we can dramatically reduce the size of laser amplifiers while providing a route to much higher peak powers than possible now, exceeding the petawatt range to possibly reach exawatts. This is a very worthy goal because very intense laser pulses can be used for fundamental studies, such as accelerating particles, helping drive nuclear fusion or even extracting particles from vacuum and recreating the conditions inside stars or the primordial condition of the universe in the laboratory. The highest power lasers in the world will be available for use at three research centres that are part of the European Extreme Light Infrastructure (ELI) project. This €850m project is dedicated to the study of light-matter interactions at the highest intensities and shortest time scales. The laser power at ELI will be 1016 Watts or 5% of the total sun's power that is absorbed on the earth at any time. These lasers will lead to new science and technology that could, for example, transform our understanding of high field physics and result in new radiotherapy modalities for the treatment of cancer. There is a need to reduce the cost of laser technology, which plasma could offer. Plasma may be a route to higher powers to go beyond those available at ELI to reach exawatt powers. The investigation was a collaboration between researchers from Strathclyde, Instituto Superior Técnico (IST) in Lisbon, Queens University Belfast, Ulsan National Institute of Science and Technology (UNIST) in South Korea, Heinrich Heine Universität, Düsseldorf and the Extreme Light Infrastructure in the Czech Republic. It was funded by the Engineering and Physical Sciences Research Council. The Research Excellence Framework 2014, the comprehensive rating of UK universities' research, ranked the University of Strathclyde's Physics research first in the UK, with 96% of output assessed as world-leading or internationally excellent.


Working for the world's largest Insurance & Banking companies, IBaseIT has quickly understood the need to adopt Robotic Process Automation and incorporate it to their business model. "We have faced situations where developing innovative software was just one part of the puzzle. The need to adopt innovation strategically is increasingly becoming a demanding requirement and transformation cannot happen in silos. The absolute next step towards digital transformation is RPA," commented Ram Yerneni, CEO from IBaseIT. "It is an undeniable fact that RPA has evolved into a strategic decision rather than a tactical one. As we are expanding in India, we see this becoming a huge trend and we have opened up a partnership program to facilitate professional services in addition to our new office in India that will be opening by the end of May, 2017," said Marios Stavropoulos, CEO at Softomotive. Balaji Hariharan, the newly appointed Managing Director, Softomotive India, stated "I am excited to look out for more business opportunities for Robotic Process Automation in India & Asia- pacific. Our new entity in India enhances our capability to serve existing and potential clients with premium Implementation and Support services". Balaji will be managing the Softomotive India office, located in Block 6A,1st Floor, RMZ Ecoworld, Bellandur Bangalore Karnataka 560103. Contact Softomotive. Softomotive, together with IBaseIT, are partnering to offer strong Quality Orientation and Cross-Technology expertise combined with distributed project management capabilities, thus guaranteeing successful on-time and on-budget project completion. Leveraging ProcessRobot, Softomotive's Robotic Process Automation solution, IBaseIT will empower enterprises to dramatically reduce operational costs, increase efficiency, improve productivity and accelerate performance. Softomotive's RPA platform will be demoed on Thursday, May 25 at 6.30 IST. Interested parties are able to register here for this live product webcast demonstration. With the right mix of technical expertise and business domain knowledge, both companies are determined to empower digital transformation - from Software Development and Product Lifecycle Management to Business Strategy and RPA implementation.


Le fardeau mondial du HSV-2 est lourd, car le virus touche plus de 400 millions de personnes qui vivent avec l'infection [1]. Les lésions génitales causées par l'herpès sont souvent très douloureuses, elles peuvent conduire à une morbidité psychologique importante, augmenter le risque de contracter le virus HIV [2-8], et elles peuvent être transmises de la mère au bébé pendant l'accouchement en laissant de sérieuses conséquences potentielles [9, 10]. ll n'existe cependant aucun traitement qui éradique le virus simplex de l'herpès du corps et le traitement de la maladie est axé sur le soulagement des symptômes, la réduction des épisodes récurrents et la prévention de la transmission virale entre les partenaires sexuels. Malgré l'utilisation de traitements médicaux et de préservatifs, la transmission de l'herpès génital peut également se produire à travers des zones non protégées de la peau par des lésions minuscules, qui sont souvent exacerbées par les pratiques de soins de la région génitale, comme le rasage et l'épilation à la cire [11]. VIBLOK est une crème pratiquement incolore, inodore et sans goût conçue pour créer une barrière protectrice de la peau qui empêche le passage des virus (par exemple, le HSV-2). Les tests en laboratoire indiquent que la crème peut bloquer le passage des virus avec un taux d'efficacité de 80 % pour un dosage correct. L'essai SAFE va offrir des indications pour savoir si VIBLOK peut bloquer en toute innocuité et efficacité le passage du virus à partir de la peau des personnes infectés par le HSV-2 et, ce faisant, cibler la haute prévalence actuelle de cette infection sexuellement transmissible (IST) dans les pays industrialisés et en développement. La Dr Annet Muetstege, titulaire d'un doctorat, est la directrice du projet clinique, et la chercheuse coordinatrice de cet essai clinique aux Pays-Bas est la Dr Vivienne van de Walle, docteur en médecine, titulaire d'un doctorat, chercheuse principale certifiée (CPI) de PreCare Trial & Recruitment. La stratégie et le protocole de l'essai clinique ont été développés avec l'aide de membres du Comité de direction de l'étude, la Professeure Anna Wald, docteur en médecine, titulaire d'un mastère en santé publique de l'École de médecine de l'université de Washington à Seattle, États-Unis, la Dr Annemarie Wensing, docteur en médecine, titulaire d'un doctorat de l'université d'Utrecht, Pays-Bas et le Professeur Charles Boucher, docteur en médecine, titulaire d'un doctorat à l'université Erasmus, Centre médical Erasmus à Rotterdam, Pays-Bas. L'étude SAFE prospective, non randomisée, comparative et multicentrique devrait durer 12 mois au cours desquels 48 participants porteurs du virus HSV-2 seront inscrits et suivis pendant un mois. Le virus HSV sera mesuré à partir de prélèvements génitaux auto-récoltés quotidiennement après l'application de la crème VIBLOK. L'essai clinique est parrainé et géré par CLJI Worldwide qui s'engage « à donner aux personnes du monde entier la possibilité de prendre des décisions intelligentes en termes de santé, et à réduire la souffrance mondiale en les protégeant contre la douleur physique et la souffrance psychologique des maladies évitables ». CLJI Worldwide a été fondé par Craig Lichtblau, docteur en médecine et Jose Iparraguirre, docteur en médecine ; deux médecins praticiens dans des spécialités différentes qui sont amis depuis plus de 30 ans. Ils ont décidé d'allier leurs connaissances avec celles d'un PDG et d'un haut dirigeant des affaires afin de bâtir une organisation qui s'efforce de soulager la douleur et la souffrance dans le monde. L'essai SAFE ne reflète que l'une des études pionnières parrainées par CLJI Worldwide, qui visent à faire de la recherche sur des aspects négligés de la santé et à résoudre par la suite des problèmes réels avec des produits ayant fait leurs preuves sur les plans scientifique et clinique. « Nous sommes enthousiastes à l'idée du lancement de l'essai SAFE car il représente une étape significative dans notre quête visant à révolutionner la prévention des infections sexuellement transmissibles et, en fin de compte, à aider des millions de femmes et d'hommes du monde entier à vivre des vies plus saines et plus heureuses », déclare Ty Cross, président du conseil et président-directeur général de CLJI Worldwide.


News Article | May 9, 2017
Site: www.prnewswire.com

Announced Positive Top-Line Data for JZP-110 in Obstructive Sleep Apnea and Narcolepsy and for Xyrem in Pediatric Narcolepsy Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2017 and updated financial guidance for 2017. "The first part of 2017 has been an exceptionally productive period for us in R&D as we announced top-line data for our three JZP-110 Phase 3 studies and our Xyrem Phase 2/3 pediatric study, completed the Vyxeos NDA submission while preparing for potential FDA approval and launch, started additional clinical programs and advanced other key development projects," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "With increased clarity around Xyrem longevity, we remain focused on delivering on our growth strategy, including preparing for the launch of additional products, such as Vyxeos, and investing in corporate development activities with the goal of further diversifying and expanding our product portfolio and offering important new therapeutic options to patients while increasing shareholder value." GAAP net income for the first quarter of 2017 was $86.5 million, or $1.41 per diluted share, compared to $75.8 million, or $1.21 per diluted share, for the first quarter of 2016. Adjusted net income for the first quarter of 2017 was $141.2 million, or $2.31 per diluted share, compared to $134.6 million, or $2.15 per diluted share, for the first quarter of 2016. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Net product sales increased 12% in the first quarter of 2017 compared to the same period in 2016 primarily due to higher net product sales of Xyrem and Defitelio. Xyrem net product sales increased 9% in the first quarter of 2017 compared to the same period in 2016. Erwinaze/Erwinase net product sales in the first quarter of 2017 were consistent with net product sales in the same period in 2016. During the quarter, the company continued to experience supply challenges, which resulted in fluctuations in inventory levels and temporary disruptions to the company's ability to supply certain markets. The company expects that temporary supply disruptions will continue in 2017, including in the U.S. Defitelio/defibrotide net product sales increased 101% in the first quarter of 2017 compared to the same period in 2016 primarily due to the launch of Defitelio in the U.S. in April 2016 and strong growth in sales in other markets. Net product sales in the U.S. were $11.6 million in the first quarter of 2017. Operating expenses changed over the prior year period primarily due to the following: As of March 31, 2017, cash, cash equivalents and investments were $407.0 million, and the outstanding principal balance of the company's long-term debt was $2.0 billion. During the first quarter of 2017, the company made a $150.0 million repayment of borrowings under the company's revolving credit facility and used $13.9 million to repurchase approximately 118,000 ordinary shares under the company's share repurchase program at an average cost of $117.65 per ordinary share. Cash flows from operations were $164.5 million in the first quarter of 2017. In March 2017, the company enrolled the first patient in a Phase 3 clinical study evaluating JZP-258, an investigational oxybate product candidate with 90 percent less sodium content than Xyrem, for the treatment of cataplexy and excessive daytime sleepiness in adult narcolepsy patients with cataplexy. In March and April 2017, the company announced positive efficacy and top-line safety results from the global Phase 3 studies evaluating JZP-110 for the treatment of excessive sleepiness in adult patients with obstructive sleep apnea (TONES 3 and TONES 4) and for the treatment of excessive sleepiness in adult patients with narcolepsy (TONES 2). In March 2017, the company entered into license agreements with Nippon Shinyaku Co., Ltd. for the development and commercialization of Defitelio and Vyxeos in Japan. On March 31, 2017, the company completed the rolling submission of an NDA to the U.S. Food and Drug Administration (FDA) for Vyxeos, an investigational treatment for acute myeloid leukemia. In April 2017, the company entered into agreements with Hikma Pharmaceuticals PLC (Hikma) resolving the company's patent litigation with Hikma related to Xyrem. In April 2017, the company announced positive efficacy and top-line safety results from the global Phase 2/3 study evaluating Xyrem for the treatment of cataplexy in pediatric patients with narcolepsy. Jazz Pharmaceuticals is updating its full year 2017 financial guidance as follows (in millions, except per share amounts and percentages): Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2017 first quarter results. The live webcast may be accessed from the Investors & Media section of the company's website at . Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 6947297. A replay of the conference call will be available through May 16, 2017 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 6947297. An archived version of the webcast will be available for at least one week in the Investors & Media section of the company's website at . Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit . To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the company presents non-GAAP adjusted net income (and the related per share measure) and its line item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line item components exclude from reported GAAP net income (and the related per share measure) and its line item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the income tax effect of non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP cost of product sales, non-GAAP selling, general and administrative expenses and non-GAAP research and development expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that each of these non-GAAP financial measures, when considered together with the company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the company's condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; and the company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' future financial and operating results, including 2017 financial guidance, potential FDA approval and launch of Vyxeos in the U.S. in 2017, the company's growth strategy, including preparing for the launch of additional products and investing in corporate development activities with the goal of further diversifying and expanding the company's product portfolio and offering important new therapeutic options to patients while increasing shareholder value, the company's expectation for continuing Erwinaze supply disruptions and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of and revenue from Xyrem, such as the potential U.S. introduction of a generic version of Xyrem before the entry dates specified in the settlements with certain companies or on terms that are different from those contemplated by the settlements; ongoing patent litigation and related proceedings; effectively commercializing the company's other products and product candidates; the regulatory approval process, including the risk that the company may be unable to obtain FDA approval for Vyxeos in the U.S. in 2017 or at all; protecting and enhancing the company's intellectual property rights; delays or problems in the supply or manufacture of the company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements; government investigations and other actions; obtaining and maintaining appropriate pricing and reimbursement for the company's products; pharmaceutical product development and the uncertainty of clinical success; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired businesses; potential restrictions on the company's ability and flexibility to pursue share repurchases and future strategic opportunities as a result of its substantial outstanding debt obligations; and the ability to achieve expected future financial performance and results; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Annual Report on Form 10-K for the year ended December 31, 2016 and future filings and reports by the company, including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-first-quarter-2017-financial-results-300454503.html


News Article | May 9, 2017
Site: www.prnewswire.co.uk

Announced Positive Top-Line Data for JZP-110 in Obstructive Sleep Apnea and Narcolepsy and for Xyrem in Pediatric Narcolepsy Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2017 and updated financial guidance for 2017. "The first part of 2017 has been an exceptionally productive period for us in R&D as we announced top-line data for our three JZP-110 Phase 3 studies and our Xyrem Phase 2/3 pediatric study, completed the Vyxeos NDA submission while preparing for potential FDA approval and launch, started additional clinical programs and advanced other key development projects," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "With increased clarity around Xyrem longevity, we remain focused on delivering on our growth strategy, including preparing for the launch of additional products, such as Vyxeos, and investing in corporate development activities with the goal of further diversifying and expanding our product portfolio and offering important new therapeutic options to patients while increasing shareholder value." GAAP net income for the first quarter of 2017 was $86.5 million, or $1.41 per diluted share, compared to $75.8 million, or $1.21 per diluted share, for the first quarter of 2016. Adjusted net income for the first quarter of 2017 was $141.2 million, or $2.31 per diluted share, compared to $134.6 million, or $2.15 per diluted share, for the first quarter of 2016. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Net product sales increased 12% in the first quarter of 2017 compared to the same period in 2016 primarily due to higher net product sales of Xyrem and Defitelio. Xyrem net product sales increased 9% in the first quarter of 2017 compared to the same period in 2016. Erwinaze/Erwinase net product sales in the first quarter of 2017 were consistent with net product sales in the same period in 2016. During the quarter, the company continued to experience supply challenges, which resulted in fluctuations in inventory levels and temporary disruptions to the company's ability to supply certain markets. The company expects that temporary supply disruptions will continue in 2017, including in the U.S. Defitelio/defibrotide net product sales increased 101% in the first quarter of 2017 compared to the same period in 2016 primarily due to the launch of Defitelio in the U.S. in April 2016 and strong growth in sales in other markets. Net product sales in the U.S. were $11.6 million in the first quarter of 2017. Operating expenses changed over the prior year period primarily due to the following: As of March 31, 2017, cash, cash equivalents and investments were $407.0 million, and the outstanding principal balance of the company's long-term debt was $2.0 billion. During the first quarter of 2017, the company made a $150.0 million repayment of borrowings under the company's revolving credit facility and used $13.9 million to repurchase approximately 118,000 ordinary shares under the company's share repurchase program at an average cost of $117.65 per ordinary share. Cash flows from operations were $164.5 million in the first quarter of 2017. In March 2017, the company enrolled the first patient in a Phase 3 clinical study evaluating JZP-258, an investigational oxybate product candidate with 90 percent less sodium content than Xyrem, for the treatment of cataplexy and excessive daytime sleepiness in adult narcolepsy patients with cataplexy. In March and April 2017, the company announced positive efficacy and top-line safety results from the global Phase 3 studies evaluating JZP-110 for the treatment of excessive sleepiness in adult patients with obstructive sleep apnea (TONES 3 and TONES 4) and for the treatment of excessive sleepiness in adult patients with narcolepsy (TONES 2). In March 2017, the company entered into license agreements with Nippon Shinyaku Co., Ltd. for the development and commercialization of Defitelio and Vyxeos in Japan. On March 31, 2017, the company completed the rolling submission of an NDA to the U.S. Food and Drug Administration (FDA) for Vyxeos, an investigational treatment for acute myeloid leukemia. In April 2017, the company entered into agreements with Hikma Pharmaceuticals PLC (Hikma) resolving the company's patent litigation with Hikma related to Xyrem. In April 2017, the company announced positive efficacy and top-line safety results from the global Phase 2/3 study evaluating Xyrem for the treatment of cataplexy in pediatric patients with narcolepsy. Jazz Pharmaceuticals is updating its full year 2017 financial guidance as follows (in millions, except per share amounts and percentages): Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2017 first quarter results. The live webcast may be accessed from the Investors & Media section of the company's website at . Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 6947297. A replay of the conference call will be available through May 16, 2017 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 6947297. An archived version of the webcast will be available for at least one week in the Investors & Media section of the company's website at . Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit . To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the company presents non-GAAP adjusted net income (and the related per share measure) and its line item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line item components exclude from reported GAAP net income (and the related per share measure) and its line item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the income tax effect of non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP cost of product sales, non-GAAP selling, general and administrative expenses and non-GAAP research and development expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that each of these non-GAAP financial measures, when considered together with the company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the company's condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; and the company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' future financial and operating results, including 2017 financial guidance, potential FDA approval and launch of Vyxeos in the U.S. in 2017, the company's growth strategy, including preparing for the launch of additional products and investing in corporate development activities with the goal of further diversifying and expanding the company's product portfolio and offering important new therapeutic options to patients while increasing shareholder value, the company's expectation for continuing Erwinaze supply disruptions and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of and revenue from Xyrem, such as the potential U.S. introduction of a generic version of Xyrem before the entry dates specified in the settlements with certain companies or on terms that are different from those contemplated by the settlements; ongoing patent litigation and related proceedings; effectively commercializing the company's other products and product candidates; the regulatory approval process, including the risk that the company may be unable to obtain FDA approval for Vyxeos in the U.S. in 2017 or at all; protecting and enhancing the company's intellectual property rights; delays or problems in the supply or manufacture of the company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements; government investigations and other actions; obtaining and maintaining appropriate pricing and reimbursement for the company's products; pharmaceutical product development and the uncertainty of clinical success; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired businesses; potential restrictions on the company's ability and flexibility to pursue share repurchases and future strategic opportunities as a result of its substantial outstanding debt obligations; and the ability to achieve expected future financial performance and results; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Annual Report on Form 10-K for the year ended December 31, 2016 and future filings and reports by the company, including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

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