Miami, FL, United States
Miami, FL, United States

Time filter

Source Type

News Article | December 7, 2016
Site: www.prweb.com

Nipendo, a leading provider of supplier collaboration cloud platform, revealed multiple enhancements introduced to its Supplier Cloud platform. Nipendo Supplier Cloud goes beyond simple transaction exchange, empowering organizations to streamline collaboration across their supply chains. The Nipendo platform replaces manual procure-to-pay processes with robotic process automation in the cloud, ensuring compliance across all supplier interactions – from bidding, foecasting and purchase orders through shipping and receiving to electronic invoicing. Highlights of the recent enhancements to the Nipendo Supplier Cloud platform include: The new Forecast Exchange Module enables organizations to share their production forecasts and manufacturing plans with their suppliers, greatly enhancing the level of predictability and confidence in the planning process. It is used by manufacturers to inform suppliers about their planned production requirements, allowing suppliers to prepare in advance, respond and react to upcoming orders, communicate their ability to meet the expected delivery schedules, and flag any anticipated issues that may impact these plans. The Task Management Module allows buyers to define order-related activities that a supplier has to complete as part of the order fulfillment process. For example, the buyer may request a supplier to attach technical specifications for the ordered item, digitally sign a document, or confirm the completion of an action. Using the Task Management Module provides buyers and suppliers with a single pane of glass to control all order-related activities, eliminating the need for multiple paper documents, emails, and phone calls which are difficult to track and manage. Nipendo Supplier Cloud can ensure that suppliers are not able to submit an invoice for an order line item until all associated tasks have been completed, providing buyers with an added layer of automated compliance and control throughout the entire procure-to-pay (P2P) process. A collection of new reports provides greater visibility into order fulfilment status, allowing buyers to quickly spot exceptions such as items that are at risk of delay beyond the order due date. Information in the reports is updated in real-time, and users can drill down from the report into the underlying data for further details and insight to take corrective actions. "The ability to keep the entire supply chain in sync at all times is critical in today’s integrated manufacturing environment,” said Nipendo CEO and Co-founder Eyal Rosenberg. “Our customers’ success lies on their ability to ensure real-time information flows across the entire supplier ecosystem, and the enhancements to the Supplier Cloud platform are already proving to provide these organizations with a greater competitive advantage.” Nipendo Supplier Cloud delivers a new level of supply chain collaboration and procure-to-pay automation across all spend categories. Nipendo provides organizations with a single point of control and compliance for all enterprise procure-to-pay processes, enabling real-time, transparent, touch-free, and error-free invoice reconciliation with over 98% of the invoices approved to pay within seconds of submission. Utilizing Nipendo’s real-time invoice validation and reconciliation, buyer organizations are able to capture a greater portion of available early payment discounts, while suppliers enjoy faster invoice-to-cash conversion at a lower cost of capital. Nipendo Supplier Cloud is used by leading organizations across industries, including multinationals such as CheckPoint, Israel Aerospace Industries, KLA Tencor, Kodak Alaris, Sigma Aldrich, and Teva Pharmaceuticals. For more information, please visit http://www.nipendo.com.


News Article | March 1, 2017
Site: globenewswire.com

Bestyrelsen foreslår, at der for regnskabsåret 2016 udbetales et udbytte på 40% af årets nettoresultat svarende til DKK 2,45 pr. aktie eller et samlet udbytte på DKK 484 millioner. H. Lundbeck A/S' bestyrelse ønskes sammensat af personer der tilsammen besidder de nødvendige finansielle, farmaceutiske og internationale kompetencer til på bedst mulig vis at varetage selskabets og dermed aktionærernes interesser under hensyntagen til selskabets øvrige interessenter. Bestyrelsens væsentligste opgaver er at fastlægge Lundbecks overordnede strategi, opstille konkrete mål for selskabets direktion samt sikre, at direktionens medlemmer har de rette kompetencer. For en mere detaljeret beskrivelse af bestyrelsens ønskede kompetencer henvises til selskabets hjemmeside: www.lundbeck.com à About us à Corporate Governance. Generalforsamlingsvalgte bestyrelsesmedlemmer vælges eller genvælges hvert år, og valgperioden for den siddende bestyrelse udløber således i forbindelse med denne generalforsamling. Bestyrelsen foreslår genvalg af følgende generalforsamlingsvalgte bestyrelsesmedlemmer: Lars Rasmussen, Lene Skole, Lars Holmqvist og Jesper Ovesen. Desuden foreslår bestyrelsen valg af Jeremy M. Levin. Terrie Curran ønsker ikke genvalg. Bestyrelsen forventer at vælge Lars Rasmussen som formand og at vælge Lene Skole som næstformand for bestyrelsen. Det er bestyrelsens vurdering, at de foreslåede kandidater tilsammen besidder den nødvendige faglige og internationale erfaring til at sikre selskabets position som en ledende global farmaceutisk virksomhed med fokus på forskning og udvikling inden for hjernesygdomme. Det er desuden bestyrelsens opfattelse, at bestyrelsens størrelse er hensigtsmæssig i forhold til selskabets behov og ambitionen om at sikre en konstruktiv debat og effektiv beslutningsproces. Der er ved udvælgelse af kandidater taget hensyn til diversitet. Det anbefales i Anbefalinger for god Selskabsledelse, at mindst halvdelen af de generalforsamlingsvalgte bestyrelsesmedlemmer er uafhængige af selskabet. Lars Rasmussen, Jesper Ovesen og Jeremy M. Levin opfylder kriterierne for uafhængighed. Lene Skole og Lars Holmqvist betragtes som afhængige i kraft af deres aktiviteter i Lundbeckfonden. I tilfælde af at de foreslåede kandidater vælges til bestyrelsen, vil bestyrelsen leve op til anbefalingen om uafhængighed som defineret i Anbefalinger for god Selskabsledelse. Lars Rasmussen har betydelig ledelsesmæssig erfaring inden for global med-tech. Lars Rasmussen blev administrerende direktør for Coloplast i 2008 og har været medlem af selskabets direktion siden 2001. Han har i denne periode haft koncernansvar for en række forskellige funktioner, herunder globalt salg, innovation og produktion. Disse ansvarsområder er varetaget med base i såvel Danmark som USA. Lene Skole er administrerende direktør for Lundbeckfonden. Inden Lene Skole kom til Lundbeckfonden i 2014, var hun økonomidirektør i Coloplast A/S og var medlem af direktionen, fra hun blev ansat i 2005. Lene Skoles ansvarsområder omfattede økonomi, IT, HR, kommunikation, strategi og M&A. Før 2005 havde Lene Skole forskellige stillinger i A.P. Møller-Mærsk gruppen, senest som økonomidirektør i Maersk Company Ltd., London, i perioden 2000-2005. Lene Skole er næstformand for bestyrelsen for DONG Energy A/S, Falck A/S og ALK-Abelló A/S og medlem af bestyrelsen for Tryg A/S og Tryg Forsikring A/S. Lars Holmqvist er medlem af bestyrelsen for Lundbeckfonden, ALK-Abelló A/S, Tecan AG og BPL Ltd. Jesper Ovesen har senest været arbejdende bestyrelsesformand i bestyrelsen for Nokia Siemens Networks BV. Han har tidligere været ansat som CFO i TDC A/S, Lego A/S og Danske Bank A/S og som finance director i Novo Nordisk A/S. Jeremy M. Levin har mere end 25 års erfaring inden for den globale medicinalindustri, hvor han har stået i spidsen for virksomheders og medarbejderes udvikling og kommercialisering af lægemidler til dækning af akutte medicinske behov i hele verden. Siden 2014 har han været administrerende direktør og bestyrelsesformand for Ovid Therapeutics, en neurologi-virksomhed med base i New York, der specialiserer sig i særlige og sjældne sygdomme i hjernen. Jeremy M. Levin var tidligere administrerende direktør for Teva Pharmaceuticals, forinden var han medlem af direktionen i Bristol-Myers Squibb, hvor han var globalt ansvarlig for den overordnede strategi, samarbejder og forretningsudvikling. Inden da var han global chef for strategiske samarbejder hos Novartis, hvor han oprettede og stod i spidsen for et strategisk samarbejde med adskillige virksomheder og forskningsinstitutioner i verden. I overensstemmelse med Revisionskomitéens anbefaling til bestyrelsen foreslår bestyrelsen genvalg af Deloitte Statsautoriseret Revisionspartnerselskab. Revisionskomitéen er ikke under indflydelse fra nogen tredjemand og er ikke underlagt nogen kontrakt med tredjemand, der begrænser generalforsamlingens valg til visse kategorier af eller lister over revisorer eller revisionsfirmaer, for så vidt angår udpegelsen af en særlig revisor eller et særligt revisionsfirma til udførelse af Selskabets lovpligtige revision. 7.1   Det foreslås, at bestyrelsen bemyndiges til indtil næste ordinære generalforsamling at lade selskabet erhverve egne aktier med en samlet nominel værdi på op til 10% af aktiekapitalen i overensstemmelse med den gældende lovgivning herom. Købskursen for de pågældende aktier må ikke afvige mere end 10% fra den ved erhvervelsen noterede kurs på Nasdaq Copenhagen A/S. H. Lundbeck A/S byder alle aktionærer, der har rekvireret adgangskort til sig selv og en eventuel medfølgende rådgiver, velkommen på generalforsamlingen. Der gøres opmærksom på, at man kun kan deltage i generalforsamlingen, hvis man har rekvireret adgangskort forud for generalforsamlingen. Adgang til generalforsamlingen sker via receptionen, Ottiliavej 9, 2500 Valby. Der er et begrænset antal parkeringspladser på Ottiliavej og Postgården. Adgangskort til generalforsamlingen kan rekvireres til og med den 24. marts 2017 på selskabets hjemmeside www.lundbeck.com., ved henvendelse til Computershare A/S, Kongevejen 418, 2840 Holte, tlf. 4546 0999, eller ved at returnere tilmeldingsblanketten til Computershare A/S. Hvis du er forhindret i at deltage på generalforsamlingen, kan du give bestyrelsen fuldmagt til at afgive de stemmer, der knytter sig til dine aktier. I så fald skal du udfylde, datere og underskrive fuldmagts-blanketten og sende den til Computershare A/S, Kongevejen 418, 2840 Holte, senest den 24. marts 2017. Ønsker du at give fuldmagt til andre end bestyrelsen, kan fuldmagtsblanketten til tredjemand anvendes. Fuldmagtsblanketterne findes på selskabets hjemmeside www.lundbeck.com. Afgivelse af fuldmagt kan tillige ske elektronisk via www.lundbeck.com senest den 24. marts 2017 ved anvendelse af depotnummer og adgangskode eller NEMID. Du kan også brevstemme ved at returnere brevstemmeblanketten i udfyldt og underskrevet stand, således at den er Computershare A/S, Kongevejen 418, 2840 Holte, i hænde senest den 29. marts 2017 kl. 12:00. Blanket til brug for stemmeafgivelse pr. brev findes på selskabets hjemmeside www.lundbeck.com,, hvor man også kan brevstemme elektronisk. H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) er et globalt farmaceutisk selskab, som er specialiseret i psykiatriske og neurologiske lidelser. I mere end 70 år har vi været førende inden for hjerneforskning. Vores primære fokusområder er Alzheimers sygdom, depression, Parkinsons sygdom og skizofreni.


News Article | March 1, 2017
Site: globenewswire.com

Notice is hereby given of the annual general meeting of H. Lundbeck A/S to be held on: The general meeting will be held at the offices of the Company at: In accordance with Article 8.1 of the Articles of Association, the agenda of the meeting is as follows: 7.1       Proposal from the Board of Directors to authorise the Board of Directors to allow the Company to acquire own shares. 7.2       Proposal from the Board of Directors to authorise the Chairman of the meeting to file for registration of the resolutions passed at the general meeting with the Danish Business Authority. The Board of Directors recommends that the report be adopted. The Board of Directors proposes that the annual report be approved. The Board of Directors proposes to distribute a dividend of 40% of the net profit for the accounting year 2016, corresponding to DKK 2.45 per share, or a total dividend of DKK 484 million. The Board of Directors of H. Lundbeck A/S should consist of persons who together possess the financial, pharmaceutical and international qualifications required for safeguarding the Company's and, thus, the shareholders' interests in the best manner possible having regard to the Company's other stakeholders. The Board of Directors' most important duties are to formulate Lundbeck's overall strategy, set specific objectives for the Company's Executive Management and ensure that the members of the Executive Management have the right qualifications. For a more detailed description of the qualifications required for members of the Board of Directors, please see the Company's website: www.lundbeck.comà About Us à Corporate Governance. Members of the Board of Directors elected by the general meeting are elected or re-elected every year, and therefore the term of office of the current members expires in connection with this annual general meeting. The Board of Directors proposes that the following members elected by the general meeting should be re-elected: Lars Rasmussen, Lene Skole, Lars Holmqvist and Jesper Ovesen. In addition, the Board of Directors proposes that Jeremy M. Levin is elected. Terrie Curran does not wish to stand for re-election. The Board of Directors expects to elect Lars Rasmussen as Chairman and elect Lene Skole as Deputy Chairman. The Board of Directors assesses that the candidates together possess the professional and international experience required for maintaining the Company's position as a leading global pharmaceutical company focusing on research and development in the field of brain disorders. The Board of Directors also considers the size of the Board appropriate taking into account the Company's needs and the aim of ensuring constructive debate and effective decision-making. Regard has been given to diversity in the selection of board candidates. The Recommendations on Corporate Governance recommend that at least half of a company's board members elected by the general meeting should be independent of the company. Lars Rasmussen, Jesper Ovesen and Jeremy M. Levin meet the criteria for independence. Lene Skole and Lars Holmqvist are considered to be non-independent board members due to their responsibilities in the Lundbeck Foundation. If the proposed candidates are elected to the Board of Directors, the Board will meet the recommendation for independence as defined by the Recommendations on Corporate Governance. The proposed board candidates have the following backgrounds: Lars Rasmussen, BSc Engineering and MBA, was born on 31 March 1959 and is a Danish citizen. He was nominated for election to Lundbeck's Board of Directors at the 2013 annual general meeting. He chairs Lundbeck’s Remuneration and Scientific Committees, and is member of Lundbeck's Audit Committee. Lars Rasmussen has considerable management experience in global med-tech. Lars Rasmussen was appointed as CEO of Coloplast A/S in 2008 and has been member of the company's executive management since 2001. In this period, he has been responsible for various functions in the group, including global sales, innovation and production. He has performed these duties from both Denmark and the USA. Lars Rasmussen's special qualifications for serving on Lundbeck's Board of Directors include his top management experience and knowledge of efficiency improvements and internationalisation. Lars Rasmussen is member of the Board of Directors of William Demant Holding A/S. Lene Skole, BCom Finance, was born on 28 April 1959 and is a Danish citizen. She was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting. She is member of Lundbeck's Remuneration and Scientific Committees. Lene Skole is CEO at the Lundbeck Foundation. Prior to joining the Lundbeck Foundation in 2014, Lene Skole was CFO at Coloplast A/S where she was a member of the company’s executive management since joining in 2005. Lene Skole’s responsibilities included finance, IT, HR, communication, strategy and M&A. Before 2005, Lene Skole held various positions in the AP Moller-Maersk group most recently as CFO of Maersk Company Ltd., London from 2000-2005. Lene Skole’s special qualifications for serving on Lundbeck’s Board of Directors include extensive knowledge and expertise within financing, strategy, business development and M&A as well as management experience from international companies including med-tech. Lene Skole is vice chairman of the Board of Directors of DONG Energy A/S, Falck A/S, ALK-Abelló A/S, and member of the Board of Directors of Tryg A/S and Tryg Forsikring A/S. Lars Holmqvist, MSc in business administration, was born on 4 September 1959 and is a Swedish citizen. He was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting. He is member of Lundbeck’s Audit Committee. Lars Holmqvist is senior advisor within healthcare at Bain Capital. He previously served as vice president responsible for sales and marketing at Pharmacia. In addition he has held management positions in several pharma and med-tech companies including Boston Scientific Corporation, Medtronic, Applied Biosystems Group, DAKO and Agilent Technologies. Lars Holmqvist’s special qualifications for serving on Lundbeck`s Board of Directors include his international management experience, his expertise in finance, and his sales and marketing experience from the global pharmaceutical, med-tech and life-science industry. Lars Holmqvist is member of the Board of Directors of the Lundbeck Foundation, ALK-Abelló A/S, Tecan AG and BPL Ltd. Jesper Ovesen, MSc in finance and state authorized public accountant, was born on 20 March 1957 and is a Danish citizen. He was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting and chairs Lundbeck’s Audit Committee. Jesper Ovesen most recently held the position of executive chairman of the Board of Directors of Nokia Siemens Networks BV. Prior to this, he served as CFO in TDC A/S, Lego A/S and Danske Bank A/S, and finance director at Novo Nordisk A/S. Jesper Ovesen’s special qualifications for serving on Lundbeck’s Board of Directors include his international management experience and his expertise in finance, accounting and international capital markets. Jesper Ovesen is vice chairman of the Board of Directors of Scandinaviska Enskilda Banken AB and member of the Board of Directors of Sunrise Communications Group AG and ConvaTec Group PLC. Jeremy M. Levin, BA Zoology, MA and DPhil in Molecular Biology and MB BChir Medicine and Surgery, was born on 9 September 1953 and is a British and US citizen. He is nominated for election to Lundbeck’s Board of Directors at the 2017 annual general meeting. Jeremy M. Levin has more than 25 years of experience in the global pharmaceuticals industry, leading companies and people to develop and commercialize medicines that address compelling medical needs worldwide. Since 2014, he has been CEO and chairman of Ovid Therapeutics, a New York-based neurology company focused on rare and orphan diseases of the brain. Previously, Jeremy M. Levin served as President & CEO of Teva Pharmaceuticals and before becoming CEO of Teva, he was a member of the Executive Committee of Bristol-Myers Squibb where he was globally responsible for overall strategy, alliances and business development. Prior to that, he was Global Head of Strategic Alliances at Novartis, where he established and managed strategic collaborations with multiple companies and research institutions around the world. Jeremy M. Levin’s special qualifications for serving on Lundbeck’s Board of Directors include a robust blend of clinical insight and experience, business development skills, corporate strategy and financial savvy. In addition he has substantial board experience. Jeremy M. Levin is member of the Board of Directors of BioCon in India, ZappRx and on the Board and Executive Committee of BIO, the Biotechnology Innovation Organization in the USA. It is proposed that the Board of Directors should receive the following remuneration for the current financial year: -     Ordinary members will receive a basic remuneration of DKK 350,000 (increased from DKK 300,000) -     The Chairman will receive three times the basic remuneration -     The Deputy Chairman will receive two times the basic remuneration -     Ordinary members of the Board Committees will receive DKK 200,000 in addition to the basic remuneration -     The committee chairmen will receive DKK 300,000 in addition to the basic remuneration In accordance with the recommendation submitted to the Board of Directors by the Audit Committee, the Board of Directors proposes that Deloitte Statsautoriseret Revisions-partnerselskab should be re-elected. The Audit Committee is free from influence by a third party and is not subject to a contract with a third party restricting the choice of the general meeting to certain categories or lists of statutory auditors or audit firms, as regards the appointment of a particular statutory auditor or audit firm to carry out the statutory audit of the Company. It is proposed to authorise the Board of Directors until the next annual general meeting to allow the Company to acquire own shares of a total nominal value of up to 10% of the share capital in accordance with applicable law. The purchase price for the relevant shares may not deviate by more than 10% from the price quoted on Nasdaq Copenhagen A/S at the time of the acquisition. The Board of Directors proposes to authorise the Chairman of the general meeting to make such amendments and additions to the resolutions passed by the general meeting and the application for registration with the Danish Business Authority that may be required by the Danish Business Authority in connection with the registration of the adopted amendments. All proposals on the agenda may be adopted by a simple majority of votes. H. Lundbeck A/S welcomes all shareholders who have obtained an admission card for themselves and for any adviser accompanying them at the general meeting. Please note that admission cards must be obtained prior to the general meeting in order to attend. Access to the general meeting is via the reception on Otilliavej 9, DK-2500 Valby. There is limited parking space available on Ottiliavej and Postgården. In accordance with Article 10.1 of the Articles of Association, admission cards will be provided to shareholders entitled to vote at the general meeting. Anyone who is registered as a shareholder in the register of shareholders on the date of registration, 23 March 2017, or who has made a request to such effect, including evidence of title to shares, that has reached the Company on that date, is entitled to vote at the general meeting (see Article 10.4 of the Articles of Association). Admission cards for the general meeting can be obtained up to and including 24 March 2017 at the Company's website www.lundbeck.com, from Computershare A/S, Kongevejen 418, DK-2840 Holte, tel. +45 4546 0999, or by returning the request form to Computershare A/S. As a new initiative admission cards will be sent out electronically via email to the email address specified in the investor portal upon registration. The admission card must be presented at the general meeting either electronically on a smartphone/tablet or printed. Shareholders who have ordered admission cards without specifying their email address can pick up the admission card at the entrance of the general meeting upon presentation of valid ID. Voting cards will be handed out at the entrance of the general meeting. The Company's nominal share capital is DKK 988,186,125 divided into shares of DKK 5 nominal value. Each share of DKK 5 carries one vote as provided by Article 10.6 of the Articles of Association. The following information and documents will be made available on the Company's website, www.lundbeck.com, on 1 March 2017: 1) The notice convening the general meeting; 2) the total number of shares and voting rights at the date of the notice; 3) all documents to be submitted to the general meeting, including the audited annual report; 4) the agenda and the full text of all proposals to be submitted to the general meeting; and 5) postal and proxy voting forms. All shareholders may ask questions in writing about the agenda and the documents to be used for the general meeting. Questions may be sent by post or by email to investor@lundbeck.com and will be answered prior to or at the general meeting. If you are prevented from attending the general meeting, the Board of Directors would be pleased to act as proxy to cast the votes attaching to your shares, in which case the proxy form, duly completed, dated and signed, must reach Computershare A/S, Kongevejen 418, DK-2840 Holte, by 24 March 2017. If you wish to appoint proxies other than to the Board of Directors, the form for appointing a third party as proxy can be used. The proxy forms are available on the Company's website, www.lundbeck.com. Proxies may also be appointed electronically on www.lundbeck.com on or before 24 March 2017 (please use custody account number and access code or the Danish NEMID). You may also vote by post by completing and signing the postal voting form and returning it to Computershare A/S, Kongevejen 418, DK-2840 Holte, so that it is received by 29 March 2017 at 12 noon. A postal voting form is available on the Company's website www.lundbeck.com, where votes may also be cast electronically. Also this year, Lundbeck offers simultaneous interpretation from Danish into English in the Auditorium. The general meeting will also be webcast live in Danish and English (can be replayed after the meeting). See the Company's website, www.lundbeck.com. If you have functional impairments which makes passage from the entrance to the Auditorium difficult you may request assistance from the staff upon arrival at the reception. H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia. Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck. The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.


News Article | February 22, 2017
Site: www.marketwired.com

SAN FRANCISCO, CA--(Marketwired - Feb 22, 2017) - SnapLogic, the leader in self-service integration, and Reltio today announced an expanded partnership to simplify enterprise data management based on their fast-growing cloud platforms, helping customers ensure connectivity, consistency and reliability of information across on-premise and cloud applications and data sources. Specifically, the two companies will embed SnapLogic's enterprise integration platform with Reltio Cloud, providing Reltio customers with a fast and easy path to integrate data sources with no coding -- and an onramp to broader usage of SnapLogic's Enterprise Integration Cloud. The two companies will also pursue joint sales, marketing and customer success programs to grow the market for self-service integration and data-driven business applications. Several joint customers, including AstraZeneca, ClubCorp and Shutterstock, already use SnapLogic and Reltio in concert to quickly and easily connect data sources to Reltio Cloud, accelerating data flow across the enterprise and enabling faster, more reliable business insight and operational execution. Executives from SnapLogic, Reltio and several customers will share best practices here next week at the first ever Modern Data Management Summit, hosted by Reltio: "Reltio is architected to provide reliable data, relevant insights, and ultimately recommended actions to both IT and business teams," said Dharma Subramanian, director of applications product management at Reltio. "Embedding SnapLogic gives our customers an out-of-the-box capability to easily share data across systems for operational execution and analytical insight, while maintaining data consistency and reliability." "Companies can no longer afford the time, cost or complexity of code-based integration," said Craig Stewart, vice president of product management at SnapLogic. "Partnering with Reltio gets self-service integration into more customers' hands, so we can break down technology barriers and help more enterprises get the right data to the right people at the right time." Reltio saw significant growth in 2016, adding customers in technology, retail, media, entertainment, transportation and insurance. Within the past year, Reltio was named a leader in "The Forrester Wave™: Master Data Management, Q1 2016" and as one of five top innovators in the "IDC Innovators: Platform as a Service, 2016" report. Several other analysts and experts have published reports highlighting Reltio's capabilities as a leader in master data management (MDM), with modern data management capabilities that go beyond master data, including IDC, Constellation Research, Ovum, 451 Research and Bloor Research. SnapLogic likewise had a record 2016, adding more than 300 new customers including significant wins with Clorox, Del Monte, Denny's, Groupon, Magellan Health, McKinsey, Teva Pharmaceuticals and Wendy's. SnapLogic's platform was recognized as one of five leaders in Gartner's 2016 Magic Quadrant for Enterprise Integration Platform as a Service (iPaaS), and one of five "solutions to know" on the Constellation ShortList for iPaaS. SnapLogic's Enterprise Integration Cloud accelerates data and process flow across cloud and on-premise applications, data warehouses, big data streams and IoT deployments. Unlike traditional integration software that requires painstaking, hand-crafted coding by teams of developers, SnapLogic makes it fast and easy to create scalable data pipelines that get the right data to the right people at the right time. Codeless integration eliminates "technical debt" while enabling analysts, data scientists and business users to create integrations in hours using visual drag-and-drop software. Under the hood, SnapLogic's powerful data streaming architecture delivers real-time processing with high throughput for faster data movement across the enterprise. About Reltio Reltio delivers reliable data, relevant insights and recommended actions so companies can be right faster. Reltio Cloud combines data-driven applications with modern data management for better planning, customer engagement and risk management. Reltio enables IT to streamline data management for a complete view across all sources and formats at scale, while sales, marketing and compliance teams use data-driven applications to predict, collaborate and respond to opportunities in real-time. Companies of all sizes, including leading Fortune 500 companies in healthcare and life sciences, media & entertainment, hospitality, distribution, insurance, personal care, and retail rely on Reltio. For more information visit www.reltio.com. About SnapLogic SnapLogic is the global leader in self-service integration. The company's Enterprise Integration Cloud makes it fast and easy to connect applications, data and things. Hundreds of customers across the Global 2000 - including Adobe, AstraZeneca, Box, Capital One, GameStop, Verizon and Wendy's - rely on SnapLogic to automate business processes, accelerate analytics and drive digital transformation. SnapLogic was founded by data industry veteran Gaurav Dhillon and is backed by blue-chip investors including Andreessen Horowitz, Capital One, Ignition Partners, Microsoft, Triangle Peak Partners and Vitruvian Partners. Learn more at www.snaplogic.com. Connect with SnapLogic via our blog, Twitter, Facebook or LinkedIn.


News Article | November 23, 2016
Site: www.newsmaker.com.au

MarketStudyReport.com adds “Precision Medicine Market Size By Technology (Big Data Analytics, Gene Sequencing, Drug Discovery, Bioinformatics, Companion Diagnostics), By Application (Oncology, CNS, Immunology, Respiratory), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Scandinavia, Italy, Japan, China, India, Singapore, Mexico, Brazil, South Africa, UAE, Qatar, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016-2023” new report to its research database. The report spread across 94 pages with table and figures in it. Global Precision Medicine Market size was more than $39.1 billion for 2015 and is predicted to register 10.51% of CAGR during forecast timeframe. It is innovative procedure for treating and preventing chronic ailments depending upon changes in individual genes and other lifestyle features. New approach helps doctors properly assess ailment risk and predict optimal treatment. Growing occurrence of cancer and increase in cancer prone geriatric population all across the globe is predicted to boost industry expansion. Threats related with sharing of patients genetic information can hinder industry growth. Insurance firms can use patient data and raise their premium for people who are at a risk of acquiring inherited diseases. Further, decline in rate of FDA (U.S. Food and Drug Administration) drug approval has minimized the rate of production of new medicines in spite of heavy investments. This aspect can hinder global precision medicine market expansion. Technology Trends The industry is segmented into different technologies like gene sequencing, companion diagnostics, big data analytics, bioinformatics and drug discovery. Gene sequencing segment size was more than $8.1 billion for 2015. Current FDA guidelines on next -generation sequencing dependent tests takes into consideration individual differences in genes of various persons, environments and life patterns while creating new type of healthcare. Companion diagnostics segment has acquired importance owing to rising concerns about rates of drug failures. Further, the segment is expanding at rapid pace owing to rise in financial support and approvals by government. Heavy throughput omics techniques applied in biological and basic research are predicted to propel bioinformatics segment growth. Out of all omics techniques next-generation technique is predicted to create key impact on the segment growth. Drug discovery technique contributed more than $9 billion for 2015 and is predicted to register CAGR of 8.31% during forecast timeframe. Further, biomarker directed treatments with medicine targeting epidermal growth factor receptor (EGFR),c-ros oncogene 1 receptor tyrosine kinase (ROS1) and anaplastic lymphoma kinase (ALK) have speeded up the production of new medicines. Precision Medicine Market Application Trends Global industry is segmented into various applications like respiratory application, oncology application, Immunology application and central nervous system (CNS) application. Oncology application contributed more than 30.1% of precision medicine market share for 2015 and is predicted to record CAGR of 10.91% during forecast timeframe. CNS application contributed more than $9.1 billion for 2015. Neuroscience therapeutics has been utilizing the approach for long duration. Regional Trends Global industry was segmented into key geographical regions like North America, MEA, Europe, APAC and Latin America. U.S. precision medicine market share was about 65.1% of revenue of North America. Factors like large allocation of budget by U.S. president to agencies like FDA( U.S. food and drug administration) , NIH (National Institute of Health) and NCI (National Cancer Institute) along with favorable government rules have contributed to the regional industry growth. Germany precision medicine market share was more than $2.5 billion for 2015 and is predicted to contribute significantly to the growth of European industry. Reason for industry growth in the region can be credited to the fact that many institutions have acquired biomarker analysis certification required for colorectal cancer detection tests. Further, medicine producing and diagnostic firms are making tremendous efforts for enhancing industry growth in Europe. Favorable compensation policies are predicted to promote industry growth in France. China contributed more than 25.1% to APAC precision medicine market share for 2015 and is predicted to remain key region in future. Favorable government initiatives and high contributions from academic labs has assisted in the regional industry growth. Competitive Trends Key industry players profiled in the report include Roche Holdings AG, Qiagen, Pfizer, Medtronic, Source Precision Medicine Incorporation, Silicon Biosystems, Tepnel Pharma Services, Covance, Biocrates Life Sciences AG, Novartis, Nanostring Technologies, Laboratory Corporation of America Holdings, Quest Diagnostics, Teva Pharmaceuticals, Intomics, Ferrer InCode, Eagle Genomics Limited and Quest Diagnostics. To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150


BOTHELL, Wash. and ATLANTA, Feb. 16, 2017 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (OTCQB:COCP), a company focused on developing novel antiviral therapeutics for human diseases, announced today that it has been selected to give an oral presentation on Saturday, February 18, 2017, 3:45 PM Shanghai time (2:45 AM ET) entitled, “Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of CC-31244, a Pan-Genotypic, Potent Non-Nucleoside NS5B Polymerase Inhibitor for the Treatment of Hepatitis C Virus Infection” at the 26th Conference of the Asian Pacific Association for the Study of the Liver (APASL) held in Shanghai, February 15-19, 2017. The interim results from the ongoing, randomized, double-blind, Phase 1a/1b study of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI) will be presented by Sam Lee, Ph.D., President and co-inventor of the drug. CC-31244 monotherapy produced up to a 3 log drop in viral load with a slow viral rebound post treatment following a 7 day treatment suggesting that CC-31244 could be an important component in an all oral, shorter HCV combination therapy. Cocrystal Pharma's interim Chief Executive Officer, Dr. Gary Wilcox said, "We are pleased to be given the opportunity to present the interim data at APASL. The interim results show that CC-31244 had a substantial and durable antiviral effect with a favorable safety and tolerability profile in both healthy volunteers and HCV GT1 infected individuals.” An archived edition of the presentation will be available on the Cocrystal website, www.cocrystalpharma.com, shortly after the event. CC-31244 is an investigational, oral, potent, pan-genotypic NNI with high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. The molecule interacts with the NS5B RNA polymerase of all major HCV genotypes. Hepatitis C is a viral infection of the liver that according to The World Health Organization in 2013 affects over 150 million people worldwide of whom only about 1% have been cured to date. The annual number of deaths due to Hepatitis C is estimated at 350,000 globally or nearly 1,000 per day. Most patients develop chronic infections, which can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer. The worldwide market for hepatitis C antiviral drugs was over $10 billion in 2016. Cocrystal is a clinical stage biotechnology company seeking to discover novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. Cocrystal employs unique technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies, including our nucleoside chemistry expertise and market-focused approach to drug discovery are designed to efficiently deliver small molecule therapeutics that are safe, effective and convenient to administer. The company has identified promising, preclinical stage antiviral compounds for several unmet medical needs, including hepatitis, influenza and norovirus infections. Cocrystal has previously received strategic investments from Teva Pharmaceuticals, OPKO Health, Brace Pharmaceutical, LLC, and The Frost Group. For further information about Cocrystal, please refer to www.cocrystalpharma.com. To the extent that the statements concerning the interim results from the ongoing Phase 1 clinical trial can be construed to imply that future results will be positive – which the Company does not comment upon – it is a  forward-looking statement. This statement reflects the current beliefs and expectations of management including statements regarding development plans for treatments related to Hepatitis C. Forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, performance or future results to differ significantly from what is expressed or implied by forward-looking statements. With regard to this clinical trial, it is subject to completion and evaluation, full regulatory review, and the company’s ability to raise additional capital to support operations.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Cocrystal has made with the Securities and Exchange Commission.


News Article | February 24, 2017
Site: www.rdmag.com

The path to developing treatments for neurodegenerative disorders hasn’t been an easy one Over the past few months, a number of pharmaceutical companies reported that promising drug candidates for Alzheimer’s came up short in late-stage studies. Prominent contenders from Eli Lilly and Merck were unable to slow or reverse mental decline in patients diagnosed with a mild to moderate forms of the condition. The complexity of this disease has made it difficult to discern the best avenue to create an effective treatment, especially since symptoms arrive in different variations and forms. One researcher, though, is working on an innovative study that could yield important markers signaling the early onset of Alzheimer’s and dementia. Rhoda Au, Ph.D., a neuropsychologist and professor at Boston University’s School of Medicine and School of Public Health, is running an e-cognitive health initiative called the, "Precision Monitoring of Preclinical Alzheimer's Disease: Framingham Study of Cognitive Epidemiology.” The goal of this study is to use wearable devices and other technology to collect large troves of data from participants over time, in an effort to pinpoint potential physical changes that could be associated with cognitive decline. About 2,200 people will be participating in this venture beginning in April 2017 with a projected end date of sometime in 2020. This investigation is different than other trials evaluating experimental drugs for the condition. “We’re testing a lot of people who are not exhibiting traces of the disease,” Au said in an exclusive interview with R&D Magazine. Some of the metrics being used in this endeavor will monitor biological signs like sleep, balance, and heart rate. Au’s team has collected over 75,000 voice recordings since 2005 to monitor voice biomarkers that could potentially show changes in speech patterns. The researchers also started giving digital pens to participants in 2013 to aggregate information on changes in writing performance. “We have been collecting sleep information through a device by Sleep Image since 2015, which is an EKG-based home sleep monitoring device.  Over 900 participants have agreed to use it so far.  Starting in April we will start to use DANA – a smartphone cognitive application created by Anthrotronix to measure cognitive performance in the home," elaborated Au. This approach provides the investigators the ability to track performance in real time without boxing people in to certain criterion, which could lead to a better continuum of performance. This program is part of a growing field called Precision Health, which focuses on medical organizations and health providers using a mix of data and healthcare analytics to enhance health outcomes for patients by creating better care and lowering the risk of readmissions. Other companies are using a similar approach to enhance research on complex disorders. Teva Pharmaceuticals and Intel struck a collaboration geared towards using a combination of wearable devices and software to continuously track functioning and movement in patients diagnosed with Huntington’s disease. The goal is to get a better understanding of the severity of motor symptoms since the current crop of drugs for this disease tend to only help moderate symptoms. A number of private partners have contributed to this program, helping Au achieve these goals. Elevation Health, IBM Watson and Pfizer are some of the companies taking part in this venture. Au elaborated that private funding has really helped explore this research, as it’s not the type of science that typically receives funding from organizations like the National Institute of Health. “Private industry can enable a different kind of science by offering equipment along with financial and professional resources not in the academic environment,” added Au. Next, the researchers will implement a number of small global pilot studies incorporating more devices into the experiment in order to ensure data integrity. “The study is a good start to see how these digital technologies can track changes by teasing out different subtypes and improving predictions,” said Au. “Catching it earlier enough with this technology could expand capacity to find changes in the normal realm for interventions.”


BOSTON--(BUSINESS WIRE)--PureTech Health plc (“PureTech” or the “Company”, LSE: PRTC), a cross-disciplinary biopharmaceutical company, today announced the appointment of Bharatt Chowrira, Ph.D., J.D., as the Company’s President and Chief of Business and Strategy. In this new role, Dr. Chowrira will work as a close partner to PureTech’s Chief Executive on strategy, corporate and business development, and value realization across PureTech Health’s pipeline. “We are thrilled to have Bharatt join PureTech Health and bring his diverse experience and deal-making track record to our team as we rapidly approach key value-driving milestones,” said Daphne Zohar, Chief Executive Officer of PureTech Health. “PureTech Health has an all-star team and an exciting, advanced pipeline which I believe has tremendous value. I look forward to working closely with Daphne and other members of this exceptional team and prestigious board to realize some of this value and raise the profile of the company with a broader group of investors and analysts. This is an exciting time to join one of the most innovative companies in healthcare and biotech,” Dr. Chowrira commented. Dr. Chowrira joins PureTech Health with more than two decades of experience in the biopharma industry, combining a unique blend of R&D, corporate development, operations, financing, public offering, M&A, legal, IP, and licensing expertise. Dr. Chowrira was most recently the President of Synlogic, a Cambridge, MA-based biopharmaceutical company focused on developing synthetic microbiome-based therapeutics, where he oversaw and managed corporate and business development, alliance management, financial, HR, IP, and legal operations. Prior to joining Synlogic, Dr. Chowrira was the Chief Operating Officer of Auspex Pharmaceuticals, which was acquired by Teva Pharmaceuticals in the spring of 2015 for $3.5 billion. Previously, he was President and Chief Executive Officer of Addex Therapeutics, a biotechnology company publicly-traded on the SIX Swiss Exchange. Before that, he held various leadership and management positions at Nektar Therapeutics, Merck & Co., Sirna Therapeutics (acquired by Merck & Co. for $1.1 billion), and Ribozyme Pharmaceuticals. Dr. Chowrira also serves on the board of Critical Outcome Technologies, Inc. He has a J.D. from the University of Denver’s Sturm College of Law, a Ph.D. in Molecular Biology from the University of Vermont College of Medicine, an M.S. in Molecular Biology from Illinois State University, and a B.S. in Microbiology from the UAS, Bangalore, India. About PureTech Health PureTech Health (PureTech Health plc, PRTC.L) is a cross-disciplinary biopharmaceutical company creating 21st century medicines that modulate the adaptive human systems. Our therapies target the immune, nervous, and gastro-intestinal systems by addressing the underlying pathophysiology of disease from a systems perspective rather than through a single receptor or pathway. We have multiple human proof-of-concept studies and pivotal or registration studies expected to read out in the next two years. PureTech Health’s rich and growing research and development pipeline has been developed in collaboration with some of the world’s leading scientific experts who, along with PureTech's experienced team and board, analyze more than 650 scientific discoveries per year to identify and advance only the opportunities we believe hold the most promise for patients. This team and process place PureTech Health on the cutting edge of ground-breaking science and technological innovation and leads the Company between and beyond existing disciplines. For more information, visit www.puretechhealth.com or connect with us on Twitter. Forward Looking Statement This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | February 15, 2017
Site: www.PR.com

The 2017 Women in Oncology Award Winners Honored by PRIMO Education The winners of the 2017 Women in Oncology Award were announced this morning at the 2nd Annual Practical Recommendations in Immuno and Molecular Oncology (PRIMO) Meeting. The Women in Oncology Awards are presented annually to three outstanding women in academia, industry, and advocacy, and seeks to recognize women who have made outstanding contributions to the lives of those fighting cancer. Wailea, HI, February 13, 2017 --( The Women in Oncology Awards are presented annually to three outstanding women in academia, industry, and advocacy, and seeks to recognize women who have made outstanding contributions to the lives of those fighting cancer. The 2017 the Women in Oncology Award Winners are: Academic Nancy Davidson, MD, is the Executive Director of the Fred Hutchinson and University of Washington Cancer Consortium, located in Seattle, WA. She is a world-renowned breast cancer researcher, who has dedicated her career to the study of cancer biology and treatment. In addition to her role at Fred Hutchinson, she is the President of the American Association for Cancer Research, and the Past-President of the American Society of Clinical Oncology. Advocacy Kathy Giusti is a Founder and Executive Chairman of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC), as well as the Faculty Co-Chair of the Harvard Business School Kraft Precision Medicine Accelerator. As Executive Chairman of the MMRF, she established innovative research models to accelerate the pace of development for lifesaving treatments, earning her recognition not only as a pioneer of precision medicine, but also as a strong advocate for patient engagement. Due to her and her foundation’s success, Ms. Giusti has earned numerous career accolades, including a #19 ranking in Fortune Magazine’s “World’s 50 Greatest Leaders”, and an appointment to President Obama’s 2015 Precision Medicine Initiative Working Group. Industry Jill DeSimone is the Head of US Oncology at Merck. Under her leadership, pembrolizumab received FDA approval in metastatic melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma, positively impacting a large number of patients across the US. Prior to her time at Merck, Ms. DeSimone was a Senior Vice President at Teva Pharmaceuticals, where she established the Global Women’s Health Unit, as well as a Senior Vice President at Bristol-Meyers Squibb. The organizers of this award, PRIMO Education and Cancer Expert Now, thank these three outstanding women for their commitment to the advancement of cancer care and advocacy, and look forward to their continuing contributions to oncology in the future. Wailea, HI, February 13, 2017 --( PR.com )-- The winners of the 2017 Women in Oncology Award were announced this weekend at the 2nd Annual Practical Recommendations in Immuno and Molecular Oncology (PRIMO) Meeting. The awards were Introduced by Charles Balch, MD, PhD(hc), of the MD Anderson Cancer Center, and presented by meeting Co-chairs Julie Brahmer, MD, MSc, of Johns Hopkins School of Medicine and Julie Vose, MD, MBA, of the University of Nebraska Medical Center.The Women in Oncology Awards are presented annually to three outstanding women in academia, industry, and advocacy, and seeks to recognize women who have made outstanding contributions to the lives of those fighting cancer. The 2017 the Women in Oncology Award Winners are:AcademicNancy Davidson, MD, is the Executive Director of the Fred Hutchinson and University of Washington Cancer Consortium, located in Seattle, WA. She is a world-renowned breast cancer researcher, who has dedicated her career to the study of cancer biology and treatment. In addition to her role at Fred Hutchinson, she is the President of the American Association for Cancer Research, and the Past-President of the American Society of Clinical Oncology.AdvocacyKathy Giusti is a Founder and Executive Chairman of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC), as well as the Faculty Co-Chair of the Harvard Business School Kraft Precision Medicine Accelerator. As Executive Chairman of the MMRF, she established innovative research models to accelerate the pace of development for lifesaving treatments, earning her recognition not only as a pioneer of precision medicine, but also as a strong advocate for patient engagement. Due to her and her foundation’s success, Ms. Giusti has earned numerous career accolades, including a #19 ranking in Fortune Magazine’s “World’s 50 Greatest Leaders”, and an appointment to President Obama’s 2015 Precision Medicine Initiative Working Group.IndustryJill DeSimone is the Head of US Oncology at Merck. Under her leadership, pembrolizumab received FDA approval in metastatic melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma, positively impacting a large number of patients across the US. Prior to her time at Merck, Ms. DeSimone was a Senior Vice President at Teva Pharmaceuticals, where she established the Global Women’s Health Unit, as well as a Senior Vice President at Bristol-Meyers Squibb.The organizers of this award, PRIMO Education and Cancer Expert Now, thank these three outstanding women for their commitment to the advancement of cancer care and advocacy, and look forward to their continuing contributions to oncology in the future.


News Article | February 21, 2017
Site: www.prnewswire.co.uk

ALBANY, New York, Feb. 21, 2017 /PRNewswire/ -- AMRI (NASDAQ: AMRI) today reported financial and operating results for the fourth quarter and full year ended December 31, 2016 and provided an outlook for 2017. "We had a number of successes in 2016 that give us confidence in our growth trajectory for 2017 and beyond," said William S. Marth, president and chief executive officer, AMRI. "Through key acquisitions and organic initiatives, we have scaled our business and strengthened our service offerings in complex science, expanded our global footprint and commercial portfolio of APIs to more than 240, and increased our capacity to address the growing demand for pharmaceutical outsourcing. Marth continued, "Our strategic vision has been to build a preeminent global contract development and manufacturing organization (CDMO) with a complete suite of services to meet the needs of both large pharmaceutical and smaller biotechnology companies. Specialized services, such as extractables and leachables testing, complement our key product offerings and expertise with sterile products, steroids, controlled substances, high potency compounds, monobactams and hormones. We believe we are well-positioned to capture significant business as more companies outsource their contract research, testing and manufacturing services." Total revenue for the fourth quarter of 2016 was $191.3 million, an increase of 51% compared to total revenue of $126.4 million in the fourth quarter of 2015. Total contract revenue for the fourth quarter of 2016 was $189.5 million, an increase of 54% compared to contract revenue of $123.0 million in the fourth quarter of 2015. Contract margins reported under GAAP were 20% in the fourth quarter of 2016, compared with 25% for the fourth quarter of 2015. Non-GAAP contract gross margins were 30% for the fourth quarter of 2016, unchanged from the fourth quarter of 2015. Non-GAAP contract gross margins reflect growth within our Discovery and Development Services (DDS) business, offset by the addition of Euticals to our Active Pharmaceutical Ingredients (API) business and a decline in our Drug Product (DP) margins. Recurring royalty revenue in the fourth quarter of 2016 was $1.9 million, down from $3.4 million in the fourth quarter of 2015, due primarily to a decline of royalties from the net sales of certain amphetamine salts sold by Teva Pharmaceuticals, partially offset by the addition of royalties resulting from our partner's sales of nitroprusside. Reported research and development expense in the fourth quarter of 2016 was $4.8 million, up from $2.7 million in the fourth quarter 2015. Non-GAAP research and development expense in the fourth quarter of 2016 was $4.9 million, up from $2.2 million in the fourth quarter 2015, reflecting increased investment in collaboration agreements and our API portfolio. Reported selling, general and administrative (SG&A) expense in the fourth quarter of 2016 was $32.3 million, up 46% from $22.2 million in the fourth quarter of 2015. Non-GAAP SG&A expense in the fourth quarter of 2016 was $24.8 million, up 52% from $16.3 million in the fourth quarter of 2015, due largely to additional SG&A from acquired businesses and investments we have made in key support functions. Reported net loss was $(15.4) million, or $(0.37) per basic and diluted share, in the fourth quarter of 2016, compared to net income of $1.8 million, or $0.05 per basic and diluted share in the fourth quarter of 2015, due primarily to increased operating expenses associated with the expanded business. Non-GAAP net income in the fourth quarter of 2016 was $14.8 million, or $0.34 per diluted share, compared to non-GAAP net income of $14.1 million or $0.40 per diluted share in 2015. Adjusted EBITDA in the fourth quarter of 2016 was $36.7 million, an increase of 38% from $26.7 million in the fourth quarter 2015. For a reconciliation of non-GAAP financial measures to U.S. GAAP financial measures for the 2016 and 2015 reporting periods, please see Tables 1-3 at the end of this press release. Total revenue for the year ended December 31, 2016 was $570.5 million, an increase of 42% compared to total revenue of $402.4 million for the twelve-month period ended December 31, 2015. Contract revenue for the year ended December 31, 2016 was $560.4 million, an increase of 46% compared to contract revenue of $384.7 million for the year ended December 31, 2015 due primarily to the acquisitions of Euticals and Gadea Pharmaceuticals (Gadea). Contract gross margins reported under GAAP were 22% for the twelve-month period ended December 31, 2016, compared to 23% in 2015. Non-GAAP contract gross margins were 30% for the twelve month period ended December 31, 2016, compared with 26% for the twelve month period ended December 31, 2015. Recurring royalty revenue for the twelve month period ended December 31, 2016 was $10.0 million, a decrease of 43% from $17.6 million in 2015, due to the expiration of Allegra (fexofenadine) royalties in the second quarter of 2015. Recurring royalty revenue for the twelve-month period ended December 31, 2016 includes $6.4 million from the net sales of mixed amphetamine salts, royalties from an API sourced from our business in Spain and royalties from net sales of nitroprusside. Reported net loss was $(70.2) million, or $(1.83) per basic and diluted share for the twelve-month period ended December 31, 2016, compared to a reported net loss of $(2.3) million, or $(0.07) per basic and diluted share for the twelve-month period ended December 31, 2015, due primarily to increased operating expenses associated with the expanded business. Non-GAAP net income for the twelve-month period ended December 31, 2016 was $37.1 million or $0.95 per diluted share, compared to non-GAAP net income of $33.0 million, or $0.96 per diluted share, for the twelve-month period ended December 31, 2015. Non-GAAP net income for 2016 reflects the contribution from recently acquired businesses, offset by a $7.6 million decline in royalty income. Adjusted EBITDA for the twelve-month period ended December 31, 2016 was $102.0 million, an increase of $26.8 million or 36%, compared to the twelve-month period ended December 31, 2015. The fourth quarter and full year 2016 reported GAAP net loss and non-GAAP net income, reported basic and diluted EPS and non-GAAP EPS results reported herein are based on an estimated tax provision that may be subject to adjustment as the Company completes the preparation of its 2016 consolidated financial statements. Any changes to the results reported herein will be set forth in the Company's Annual Report on Form 10-K. At December 31, 2016, AMRI had cash, cash equivalents and restricted cash of $50.8 million, compared to $45.0 million at September 30, 2016 and $52.3 million at December 31, 2015, respectively. API contract revenue for the fourth quarter of 2016 increased 81% compared to the fourth quarter of 2015 primarily due to $69 million of incremental revenue from the acquisition of Euticals, partially offset by lower revenue at our Rensselaer, N.Y. facility. API reported contract gross margin for the fourth quarter of 2016, decreased 8 percentage points compared to the fourth quarter of 2015, inclusive of the impact of acquisition accounting associated with Euticals. API non-GAAP contract gross margin for the fourth quarter of 2016 increased slightly from the fourth quarter of 2015, reflecting an enhanced product mix and operational enhancements. API royalty revenue in the fourth quarter of 2016 declined $2.1 million from 2015, reflecting lower royalties from the net sales of mixed amphetamine salts. For the twelve-month period ended December 31, 2016, API contract revenue increased $133.0 million or 65% from the year ended December 31, 2015, due primarily to $156.2 million of incremental revenue from the acquisitions of Gadea and Euticals, partially offset by lower organic revenue associated with the timing of product transfers from the Holywell, UK site closure. API reported contract gross margin for the twelve-month period ended December 31, 2016 decreased 5 percentage points compared to the twelve-month period ended December 31, 2015, inclusive of the impact of acquisition accounting adjustments associated with the acquisitions of Gadea and Euticals. API non-GAAP contract gross margin for the twelve-month period ended December 31, 2016 increased 2 percentage points compared to the twelve-month period ended December 31, 2015, driven by the margins realized on Gadea and legacy AMRI revenues. DDS contract revenue for the fourth quarter of 2016 increased 21% compared to the fourth quarter of 2015, due primarily to incremental revenue of $4.3 million from the acquisition of Whitehouse Laboratories and Euticals, and organic growth in the underlying business. DDS reported contract gross margin increased 10 percentage points in the fourth quarter of 2016 as compared to the fourth quarter of 2015. DDS non-GAAP contract gross margin increased 9 percentage points for the fourth quarter of 2016 as compared to the fourth quarter of 2015, driven by the margins realized on Whitehouse Laboratories' revenue and greater efficiencies in our discovery services. For the twelve-month period ended December 31, 2016, DDS contract revenue increased 26% from the 2015 period due primarily to the acquisition of Whitehouse Laboratories and Euticals, and organic growth in the underlying business. DDS reported contract gross margin for the twelve-month period ended December 31, 2016 increased 6 percentage points compared with the twelve-month period ended December 31, 2015. DDS non-GAAP contract gross margin for the twelve-month period ended December 31, 2016 increased 6 percentage points from the twelve-month period ended December 31, 2015, driven by the margins realized on Whitehouse Laboratories' revenues and operational efficiencies. DP contract revenue for the fourth quarter of 2016 decreased 21% compared to the fourth quarter 2015, primarily due to lower production volume at our Albuquerque, N.M. commercial manufacturing facility. DP reported contract gross margin for the fourth quarter 2016 decreased 8 percentage points compared to the fourth quarter of 2015. DP non-GAAP contract gross margin for the fourth quarter of 2016 decreased 9 percentage points compared to the fourth quarter of 2015, primarily due to lower volumes at our Albuquerque, N.M. facility. DP contract revenue for the twelve-month period ended December 31, 2016 increased 2% compared to the twelve-month period ended December 31, 2015, primarily due to the addition of Gadea. DP reported contract gross margin for the twelve-month period ended December 31, 2016 increased 5 percentage points compared to the twelve-month period ended December 31, 2015. DP non-GAAP contract gross margin for the twelve-month period ended December 31, 2016 increased 4 percentage points compared to the twelve-month period ended December 31, 2015, driven by enhanced operating efficiencies at our Albuquerque, N.M. commercial manufacturing facility. Fine Chemicals (FC) is a new reporting segment for AMRI resulting from the acquisition of Euticals. Consequently, there are no comparative prior period amounts. Non-GAAP contract gross profit and margin reflect the impact of acquisition accounting associated with the acquisition of Euticals. AMRI's guidance takes into account a number of factors, including expected financial results for 2017, anticipated tax rates, foreign currency fluctuations and shares outstanding. Total Revenue $710 to $740 million Add: Negative effect of foreign exchange (1%) Revenue growth, reported at the mid point 28% Less: Contributions from acquisitions (1) (15% to 16%) Revenue growth, organic (2) 7% DDS Contract revenue growth, organic 12% API Contract revenue growth, organic 8% DP Contract revenue growth, organic 8% FC Contract revenue growth, organic (28%) GAAP contract margin 26% Non-GAAP contract margin (3) ~29% GAAP R&D expense, as a percent of revenue 2% Non-GAAP R&D expense, as a percent of revenue 2% GAAP SG&A, as a percent of revenue 18% Non-GAAP SG&A, as a percent of revenue (3) 15% GAAP Net loss ($12) to ($7) million Non-GAAP Net income (3) $47 to $52 million Adjusted EBITDA (3) $135 to $145 million Adjusted EBITDA, as a percent of revenue (3) 19% to 20% GAAP diluted EPS ($0.28) to ($0.16) Non-GAAP diluted EPS (3) (4) $1.08 to $1.20 Capital expenditures $35 to $40 million Footnotes to Guidance Table (1) Reflects the acquisition of Euticals which was completed in July 2016. (2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions and foreign currency translation. (3) Refer to Table 4 included in this release for reconciliation of forward-looking non-GAAP financial measures to forward looking GAAP financial measures. (4) Assumes tax rate of approximately 28% and 44 million shares outstanding. AMRI will host a conference call and webcast today at 8:30 a.m. ET to discuss fourth quarter and full year 2016 results, as well as guidance for 2017. The conference call can be accessed by dialing (866) 208-5728 (domestic calls) or (224) 633-1279 (international calls) at 8:20 a.m. ET and entering passcode 61743127. The webcast and supplementing slides can be accessed on the company's website at www.amriglobal.com. A replay of the conference call can be accessed for 24 hours at (855) 859-2056 (domestic calls) or (404) 537-3406 (international calls) and entering passcode 75749093. Replays of the webcast can also be accessed for up to 90 days after the call via the investor area of the company's website at http://ir.amriglobal.com. About AMRI Albany Molecular Research Inc. (AMRI) is a global contract research and manufacturing organization that has been working with the Life Sciences industry to improve patient outcomes and the quality of life for more than two decades. With locations in North America, Europe and Asia, our key business segments include Discovery and Development Services (DDS), Active Pharmaceutical Ingredients (API), Drug Product (DP), and Fine Chemicals (FC). For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal). Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, all of the estimates under "Financial Outlook" and statements regarding, among other things, the performance of the Company's previously acquired businesses, the strength of the Company's commercial operations and prospects, projections regarding future revenues and financial performance, and the Company's momentum and long-term growth. The words "outlook", "guidance", "anticipates", "believes", "expects", "may", "plans", "predicts", "will", "potential", "goal" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers should not place undue reliance on these forward-looking statements. The Company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the Company may not be able to predict and may not be within the Company's control. Factors that could cause such differences include, but are not limited to, the ability of the Company to successfully integrate its acquired businesses and achieve the expected financial results; ongoing headwinds in the U.S. and other world economies which could lead to overall softness in the markets the Company serves; difficulty in raising new capital to support the Company's business, including financing our debt obligations, capital expenditures and acquisitions; trends in pharmaceutical and biotechnology companies' outsourcing of manufacturing services and chemical research and development, including softness in these markets; the success of the sales of the products for which the Company receives royalties; the risk that the Company will not be able to replicate either in the short or long term the revenue stream that has historically been derived from the royalties payable under the Allegra® license agreements; the risk that clients may terminate or reduce demand under any strategic or multi-year deal; the Company's ability to enforce its intellectual property and technology rights; the Company's ability to successfully comply with heightened FDA scrutiny on aseptic fill/finish operations; the results of further FDA inspections; the Company's ability to effectively maintain compliance with applicable FDA and DEA regulations; the impact of foreign currency fluctuations; and the Company's ability to take advantage of proprietary technology and expand the scientific tools available to it; as well as those risks discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2015 as filed with the Securities and Exchange Commission (SEC) on March 30, 2016, subsequent Quarterly Reports filed with the SEC and the Company's other SEC filings. The financial guidance offered by senior management with respect to 2017 represents a point-in-time estimate and is based on information as of the date of this press release. Senior management has made numerous assumptions in providing this guidance which, while believed to be reasonable, may not prove to be accurate. Numerous factors, including those noted above, may cause actual results to differ materially from the guidance provided. The Company expressly disclaims any current intention or obligation to update the guidance provided or any other forward-looking statement in this press release to reflect future events or changes in facts assumed for purposes of providing this guidance or otherwise affecting the forward-looking statements contained in this press release. Non-GAAP Financial Measures To supplement our financial results prepared in accordance with U.S. GAAP, we have presented non-GAAP measures of contract gross profit, contract gross margin, gross profit, gross margin, net income, and earnings per diluted share, adjusted to exclude certain charges (and gains when applicable) that relate to specific events or transactions, such as impairment charges, restructuring charges, executive transition costs, business acquisition costs, realized and unrealized gains and losses on foreign currency transactions related to business acquisitions, non-recurring professional fees, ERP implementation costs, insurance recoveries on business interruption events, and gains on sales of facilities in the 2016 and 2015 periods presented. Management typically excludes these amounts when evaluating our operating performance and believes that the resulting non-GAAP measures provide investors with a consistent basis for comparison across periods and, therefore, are useful to investors in assessing our operating performance. Our U.S. GAAP measures are also adjusted to exclude certain non-cash charges (and gains when applicable) such as non-cash debt interest and amortization charges, share-based compensation expense, acquisition accounting inventory adjustments, and acquisition accounting depreciation and amortization for the periods presented for 2016 and 2015. Management typically excludes the amounts described above when evaluating our operating performance and believes that the resulting non-GAAP measures are useful to investors in assessing our operating performance. We have also presented the non-GAAP measure of adjusted EBITDA, which in addition to the items excluded above, further excludes the impact of interest income and expense, depreciation and amortization expense, and income tax expense or benefit. We believe presentation of our non-GAAP measures enhances an overall understanding of our historical financial performance because we believe these measures are an indication of the performance of our base business. Management uses these non-GAAP measures as a basis for evaluating our financial performance as well as for budgeting and forecasting of future periods. For these reasons, we believe they can be useful to investors. The presentation of this additional information should not be considered in isolation or as a substitute for the related GAAP measures. Reconciliations of these non-GAAP measures to the most directly comparable GAAP financial measures are set forth in Tables 1-3. A reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures has been included in Table 4. Table 1: Reconciliation of three and twelve-months ended December 31, 2016 and 2015 reported contract gross profit and contract gross margin to non-GAAP contract gross profit and non-GAAP contract gross margin: Table 2: Reconciliation of non-GAAP measures for the three and twelve months ended December 31, 2016 and 2015: Table 3: Reconciliation of the three and twelve months ended December 31, 2016 and 2015 reported net (loss) income to adjusted EBITDA: Table 4: Reconciliation of forward-looking non-GAAP financial measures to forward looking GAAP financial measures: When planning, forecasting and analyzing future periods, the Company does so primarily on a non-GAAP basis without preparing a GAAP analysis as that would require estimates for various reconciling items that would be difficult to predict with reasonable accuracy. For example, it is difficult for the Company to anticipate the need for, or magnitude of, any presently unforeseen one-time restructuring expense or business acquisition costs. As a result, the Company has prepared the below reconciliation using estimates of reconciling items that are currently expected to be excluded from the non-GAAP financial measures in future periods. The Company is unable to include all reconciling items at this time without unreasonable effort due to the unavailability of the information needed to calculate reconciling items and due to variability, complexity and limited visibility to events or conditions in future periods.

Loading Teva Pharmaceuticals collaborators
Loading Teva Pharmaceuticals collaborators