Agilux Laboratories

Worcester, MA, United States

Agilux Laboratories

Worcester, MA, United States
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News Article | May 29, 2017
Site: www.prnewswire.com

NEW YORK, May 29, 2017 /PRNewswire/ -- This report analyzes the worldwide markets for Contract Research Outsourcing in US$ Million by the following Service Segments: Drug Discovery, Preclinical Research, and Clinical Research. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 115 companies including many key and niche players such as - Albany Molecular Research, Inc. - Charles River Laboratories International, Inc. - Chiltern International Ltd. - ICON plc Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations Disclaimers Data Interpretation & Reporting Level Quantitative Techniques & Analytics Product Definitions and Scope of Study II. EXECUTIVE SUMMARY 1. INDUSTRY OVERVIEW Outsourcing of R&D Projects to Propel CROs Services Market Growth Drivers in a Nutshell Evolving Macro Trends Driving CRO Demand CROs to Significantly Drive Outsourcing Penetration Focus on Efficient, Quality Services to Drive Specialty CROs Market Rise in Investments to Boost Growth Key Therapeutic Areas of Clinical Trial Research Table 1: Global Clinical Trial Services Market by Therapeutic Area: 2016 (includes corresponding Graph/Chart) Primary Factors Influencing CRO Market Pharma and Biotech Companies to Increase Dependence on CROs Outlook Notable Regional Developments Future Model of CRO 2. COMPETITIVE SCENARIO CRO - A Highly Fragmented Market Table 2: Leading Players in the Global Contract Research Outsourcing Market (2016E): Percentage Breakdown of Revenues by Player (includes corresponding Graph/Chart) Table 3: Percentage Breakup of Life Sciences Revenues (2016) of Major Players by Service Type- Preclinical, Phase I, Phase IIA, Phase IIB, Phase III, Phase IV/ Post-Approval, Central Lab and Others Large CROs Seek the Inorganic Growth Route Global CRO Marketspace - A Review of the M&A Activity in the Recent Years Select M&A Activity in the Global CRO Market Noteworthy Contracts of Major CROs CROs Adept with New Technologies to See More Business in Future Streamlining Development of Novel Trial Designs CROs with End-to End Capabilities in Demand Key Opportunities for CROs Technological Superiority - A Definite Advantage Strategies and Tactical Programs for CROs Survival Strategies in Mature CRO Markets Exit from the Industry Expand Scale Capture Niche Segments Strategies to Tap Opportunities in Growing Markets Mobilize Funds Expand Other Services Upgrade Technological and Knowledge Base Form Sub-Contracts or Regional Alliances 3. GROWTH DRIVERS, MARKET TRENDS & ISSUES Increased Spend on R&D Outsourcing Table 4: Global Pharmaceutical R&D Spending (US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart) Table 5: Percentage Breakdown of Total Number of Compounds in Pipeline by Phase for Pre-Clinical, Phase I, Phase II and Phase III: 2016E (includes corresponding Graph/Chart) Enhancing Site Selection and Patient Enrollment CROs Enter into Alliances to Improve Efficiencies Adoption of Digital Technologies Gains Pace Rising Late-Stage Services Demand and Budget Restraints Drive Market Growth Toxicology Services Gain Notable Attention Pharma Companies Enter into Licensing Agreements with Biotech Companies for New Drug Discovery - A Mutually Beneficial Strategy Pharmaceutical & Biopharmaceutical Trends to Support CRO Penetration Table 6: Global Biopharma % R&D Outsourcing (2014-2020) (includes corresponding Graph/Chart) Table 7: New FDA Drug Approvals (2010-2016): Breakdown of Number of Approvals by Type for New Molecular Entity (NME) and Biologic License Application (BLA) Approvals (includes corresponding Graph/Chart) Focus on Regulatory Oversight and Enhanced Transparency Bodes Well for CROs eClinical Solutions Gain Traction Other Noteworthy Market Trends CROs Monetize Data Service Differentiation - A Sustaining Strategy CROs Tie Up with Diagnostic Companies for Patients Research Networks Move to Cloud Application of Mobile Devices to Collect Real Time Data Gains Ground CROs Provide Exclusive Offers to Lure Big Pharma Challenges Faced by Contract Research Organizations On-shore versus Offshore CRO Business Cutthroat Competition among CROs Management of Clinical Investigation Cost Containment Safety Concerns on Clinical Trials Pipeline Blocks Surging Global Population Offers Increased Growth Opportunities Table 8: Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (In Million) (includes corresponding Graph/Chart) Aging Population Boosts Opportunities for CRO Table 9: Global Population Statistics for the 65+ Age Group (2015) (includes corresponding Graph/Chart) Table 10: Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart) Increasing Healthcare Expenditure to Spur Demand for Generics Table 11: Healthcare Spending as a Percentage of GDP by Region (2016E) (includes corresponding Graph/Chart) 4. CONTRACT RESEARCH OUTSOURCING - AN INSIGHT Concept Contract Research Organizations (CRO) Contract Research Outsourcing Major CRO Services Ancillary CRO Services Advantages from CRO Drug Discovery Pre-Clinical Studies Clinical Research - Factors Encouraging CRO Services at Various Phases Phase I Phase II Phase III Phase IV 5. RECENT INDUSTRY ACTIVITY WuXi AppTec Takes Over HD Biosciences Laboratory Corporation of America Holdings to Acquire Pharmaceutical Product Development PRA Health Sciences and Takeda Pharmaceutical Inks New Partnership AMRI Enters into Alliance with Bruker Daltonics and HighRes Biosolutions Pharmaceutical Product Development Establishes Rare Disease and Pediatric Center of Excellence Pharmaceutical Product Development to Start Clinical Research Unit in Las Vegas Bracket Acquires CLINapps PAREXEL International to Acquire ExecuPharm Cinven to Takeover BioClinica ICON to Takeover Clinical Research Management Pharmaceutical Product Development Acquires Evidera Velocity Fund Partners Acquires Indipharm Bioclinica Snaps Up Compass Research Charles River Laboratories International Takes Over Agilux Laboratories Charles River Laboratories International Snaps Up Blue Stream Laboratories Charles River Laboratories International Acquires WIL Research Pharmaron Announces the Acquisition of Quotient Bioresearch Amulet Capital Partners Acquires SynteractHCR Holdings IMS Health Merges with Quintiles Almac Clinical Technologies Enters into Partnership with inVentiv Health CSSi LifeSciences Unveils Fully Integrated Medical Device CRO Lovelace Biomedical Commences Operations as Preclinical CRO PAREXEL International Inks Services Agreement with Pfizer BioDuro Commences Operations as a Contract Research and Manufacturing Firm Charles River Laboratories International Forms Partnership with BioMotiv Laboratory Corporation of America Acquires Covance Charles River Laboratories International Snaps Up Oncotest Chiltern Acquires Theorem Clinical Research Charles River Laboratories International Takes Over Celsis International Albany Molecular Research Unveils Integrated Drug Discovery Center 6. FOCUS ON SELECT GLOBAL PLAYERS Albany Molecular Research, Inc. (USA) Charles River Laboratories International, Inc. (USA) Chiltern International Ltd. (UK) ICON plc (Ireland) INC Research, LLC (USA) InVentiv Health, Inc. (USA) Jubilant Biosys Ltd. (India) Laboratory Corporation of America® Holdings (USA) PAREXEL International Corp. (USA) Pharmaceutical Product Development, LLC. (USA) Pharmaron (China) PRA Health Sciences, Inc. (USA) Quintiles IMS Holdings, Inc. (USA) Ricerca Biosciences LLC (USA) Sygnature Discovery Limited (UK) SynteractHCR (USA) WuXi AppTec (China) 7. GLOBAL MARKET PERSPECTIVE Table 12: World Recent Past, Current & Future Analysis for Contract Research Outsourcing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 13: World Historic Review for Contract Research Outsourcing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 14: World 14-Year Perspective for Contract Research Outsourcing by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 15: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Drug Discovery by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 16: World Historic Review for Contract Research Outsourcing for Drug Discovery by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 17: World 14-Year Perspective for Contract Research Outsourcing for Drug Discovery by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 18: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Preclinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 19: World Historic Review for Contract Research Outsourcing for Preclinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 20: World 14-Year Perspective for Contract Research Outsourcing for Preclinical Research by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 21: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Clinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 22: World Historic Review for Contract Research Outsourcing for Clinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 23: World 14-Year Perspective for Contract Research Outsourcing for Clinical Research by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) III. MARKET 1. THE UNITED STATES A.Market Analysis Outlook Drug Developers Rely on CROs to Improve Trial Efficiency and Cost Savings Trial Services Witness Higher Demand Strong Demand for Data Management Services Focus on Innovation and Productivity CROs Focus on Adaptive Clinical Trials Risk-based Monitoring Catches Pace Strategic Corporate Developments Key Players B.Market Analytics Table 24: US Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 25: US Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 26: US 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 2. CANADA Market Analysis Table 27: Canadian Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 28: Canadian Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 29: Canadian 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 3. JAPAN A.Market Analysis Strategic Corporate Development B.Market Analytics Table 30: Japanese Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 31: Japanese Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 32: Japanese 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 4. EUROPE A.Market Analysis Outlook Providers Expand Services in Downstream Drug Development Strategic corporate developments Key Players B.Market Analytics Table 33: European Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 34: European Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 35: European 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 5. ASIA-PACIFIC A.Market Analysis Outlook Asia-Pacific to Push up Volume Share in CRO Market R&D Outsourcing in Life Sciences on Rise Focus on Select Regional Markets China Market with Strong Growth Potential India Australia Popular Destination for Early Phase Clinical Trials Cost Savings through Tax Incentives Supportive Regulatory Framework Government Focus on Reducing Cost and Time Superior Clinical Trial Quality Strategic Corporate Development Key Players B.Market Analytics Table 36: Asia-Pacific Recent Past, Current & Future Analysis for Contract Research Outsourcing by Geographic Region - China, India and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 37: Asia-Pacific Historic Review for Contract Research Outsourcing by Geographic Region - China, India and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 38: Asia-Pacific 14-Year Perspective for Contract Research Outsourcing by Geographic Region - Percentage Breakdown of Revenues for China, India and Rest of Asia-Pacific Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 39: Asia-Pacific Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 40: Asia-Pacific Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 41: Asia-Pacific 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 6. REST OF WORLD A.Market Analysis Outlook Providers with Specialized Research Techniques to Boost Latin American CRO Market B.Market Analytics Table 42: Rest of World Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 43: Rest of World Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 44: Rest of World 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 115 (including Divisions/Subsidiaries - 120) The United States (47) Canada (5) Japan (1) Europe (27) - France (2) - Germany (6) - The United Kingdom (3) - Spain (1) - Rest of Europe (15) Asia-Pacific (Excluding Japan) (35) Latin America (4) Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-contract-research-outsourcing---services-300465052.html


WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the first quarter of 2017. Revenue from continuing operations was $445.8 million, an increase of 25.6% from $354.9 million in the first quarter of 2016. Revenue growth was driven primarily by the Discovery and Safety Assessment and Manufacturing Support segments. Research Models and Services revenue also increased. The acquisitions of WIL Research, Agilux Laboratories, and Blue Stream Laboratories contributed 19.5% to consolidated first-quarter revenue growth, both on a reported basis and in constant currency. The impact of foreign currency translation reduced reported revenue growth by 2.1%. Excluding the effect of these items, organic revenue growth was 8.2%. On a GAAP basis, first-quarter net income from continuing operations attributable to common shareholders was $46.8 million, an increase of 25.9% from $37.2 million for the same period in 2016. First-quarter diluted earnings per share on a GAAP basis were $0.97, an increase of 24.4% from $0.78 for the first quarter of 2016. The divestiture of the Contract Development and Manufacturing (CDMO) business, which was completed on February 10, 2017, reduced GAAP earnings per share by $0.15 (net) as a result of the tax impact of the transaction, partially offset by the gain on the sale. In addition, an excess tax benefit associated with stock compensation contributed $0.15 to GAAP earnings per share in the first quarter of 2017. On a non-GAAP basis, net income from continuing operations was $62.6 million for the first quarter of 2017, an increase of 34.4% from $46.5 million for the same period in 2016. First-quarter diluted earnings per share on a non-GAAP basis were $1.29, an increase of 31.6% from $0.98 per share for the first quarter of 2016. On a non-GAAP basis, a favorable tax rate benefited earnings per share by $0.10 in the first quarter of 2017, as the $0.15 excess tax benefit associated with stock compensation was partially offset by the earnings mix. Both the GAAP and non-GAAP earnings per share increases were driven primarily by the acquisition of new businesses, notably WIL Research, as well as higher revenue for legacy operations. Earnings per share in the first quarter also included a gain from the Company’s venture capital investments, which contributed $0.05 per share compared to a $0.04 gain for the same period in 2016. James C. Foster, Chairman, President and Chief Executive Officer, said, “I am very pleased to say that following an exceptional year in 2016, we are off to a strong start in the first quarter of 2017. Demand for our products and services is robust and we continue to win new business, which supports our expectation for revenue growth, operating margin expansion, and earnings per share growth in 2017. Our first-quarter results put us on track to achieve our guidance for the year.” “We have successfully implemented our strategy to become the early-stage CRO of choice as a result of a three-pronged approach. First, we are continuing to expand our unique portfolio of essential products and services, which increases our relevance to our clients’ drug research, development, and manufacturing efforts. Second, we continue to expand and enhance our scientific expertise and depth, which we believe is unique and unparalleled in the early-stage CRO universe, and a strong differentiating factor. Third, we maintain an intense focus on efficiency and responsiveness, which enables us to provide exceptional, flexible service to clients without adding significant cost,” Mr. Foster concluded. Revenue for the RMS segment was $127.2 million in the first quarter of 2017, an increase of 3.1% from $123.3 million in the first quarter of 2016. Organic revenue growth was 4.7%, driven by higher revenue for both the Research Models and Research Model Services businesses. In the first quarter of 2017, the RMS segment’s GAAP operating margin increased to 29.7% from 29.5% in the first quarter of 2016. On a non-GAAP basis, the operating margin was 30.1%, unchanged on a year-over-year basis. Revenue from continuing operations for the DSA segment was $227.8 million in the first quarter of 2017, an increase of 44.2% from $158.0 million in the first quarter of 2016. Growth was driven primarily by the acquisitions of WIL Research and Agilux Laboratories, which contributed 41.6% to DSA revenue growth. Organic revenue growth was 5.1%, as growth in the legacy Safety Assessment business was partially offset by lower revenue for the legacy Discovery Services business. Revenue growth was driven by demand from both global biopharmaceutical and mid-tier biotechnology clients. In the first quarter of 2017, the DSA segment’s GAAP operating margin decreased to 17.0% from 19.5% in the first quarter of 2016. The GAAP operating margin decline was due in part to amortization of intangible assets related to acquisitions. On a non-GAAP basis, the operating margin decreased to 20.9% from 23.3% in the first quarter of 2016. Both the GAAP and non-GAAP operating margins were affected by revenue mix and acquisitions. Revenue for the Manufacturing segment was $90.8 million in the first quarter of 2017, an increase of 23.5% from $73.5 million in the first quarter of 2016. The acquisitions of Blue Stream Laboratories and WIL Research’s CDMO business (divested on February 10, 2017) contributed 4.9% to Manufacturing revenue growth in the first quarter of 2017. Organic revenue increased 20.6%, driven primarily by robust growth in the Microbial Solutions and Biologics Testing Solutions businesses. In the first quarter of 2017, the Manufacturing segment’s GAAP operating margin increased to 29.3% from 26.7% in the first quarter of 2016. On a non-GAAP basis, the operating margin increased to 33.2% from 31.3% in the first quarter of 2016. Both the GAAP and non-GAAP operating margin improvement was driven by leverage from higher revenue in the Microbial Solutions and Biologics Testing Solutions businesses. During the first quarter of 2017, the Company reinitiated stock repurchase activity, repurchasing 363,000 shares for a total of $32.1 million. As of April 1, 2017, the Company had $37.6 million remaining on its authorized stock repurchase program. On May 9, 2017, the Company’s Board of Directors increased the stock repurchase authorization by $150 million, to an aggregate amount of $1.3 billion. The Company is updating guidance for 2017, which was originally provided on February 14, 2017. The Company is reducing GAAP earnings per share guidance primarily to reflect the net impact of the divestiture of the CDMO business, and increasing the top end of the non-GAAP earnings per share guidance range, primarily to reflect the higher-than-expected excess tax benefit associated with stock compensation. The revised earnings per share guidance does not include an additional contribution from venture capital investments, or a meaningful contribution from the excess tax benefit associated with stock compensation, in the remaining three quarters in 2017. The Company is maintaining its revenue guidance for 2017. (1) The contribution from acquisitions reflects only those acquisitions which were completed in 2016. (2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions, the divestiture of the CDMO business, the 53rd week, and foreign currency translation. (3) These charges relate primarily to the Company’s planned efficiency initiatives in 2017, including site consolidation costs, asset impairments, and severance. Other projects in support of the global productivity and efficiency initiatives are expected, but these charges reflect only the decisions that have already been finalized. (4) These adjustments are related to the evaluation and integration of acquisitions and the divestiture of the CDMO business, and primarily include transaction, advisory, and certain third-party integration costs, as well as certain costs associated with acquisition-related efficiency initiatives. (5) These adjustments include the preliminary net gain and tax impact related to the divestiture of the CDMO business. Charles River has scheduled a live webcast on Wednesday, May 10, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website. Charles River will present at the Bank of America Merrill Lynch 2017 Health Care Conference in Las Vegas, Nevada, on Tuesday, May 16, at 9:20 a.m. PT (12:20 p.m. ET). Management will provide an overview of Charles River’s strategic focus and business developments. A live webcast of the presentation will be available through a link that will be posted on ir.criver.com. A webcast replay will be accessible through the same website shortly after the presentation and will remain available for approximately two weeks. The Company reports non-GAAP results in this press release, which exclude often one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release. In addition, the Company reports results from continuing operations, which exclude results of the Phase I clinical business that was divested in 2011. The Phase I business is reported as a discontinued operation. Use of Non-GAAP Financial Measures This press release contains non-GAAP financial measures, such as non-GAAP earnings per diluted share, which exclude the amortization of intangible assets, inventory purchase accounting adjustments, and other charges related to our acquisitions; expenses associated with evaluating and integrating acquisitions and divestitures, as well as fair value adjustments associated with contingent consideration; charges, gains, and losses attributable to businesses or properties we plan to close, consolidate, or divest; severance and other costs associated with our efficiency initiatives; gain on and tax effect of the divestiture of the CDMO business; and costs related to a U.S. government billing adjustment and related expenses. This press release also refers to our revenue in both a GAAP and non-GAAP basis: “constant currency,” which we define as reported revenue growth adjusted for the impact of foreign currency translation, and “organic revenue growth,” which we define as reported revenue growth adjusted for foreign currency translation, acquisitions, the divestiture, and the 53rd week. We exclude these items from the non-GAAP financial measures because they are outside our normal operations. There are limitations in using non-GAAP financial measures, as they are not prepared in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. In particular, we believe that the inclusion of supplementary non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of our core operating results and future prospects without the effect of these often one-time charges, and is consistent with how management measures and forecasts the Company's performance, especially when comparing such results to prior periods or forecasts. We believe that the financial impact of our acquisitions and divestitures (and in certain cases, the evaluation of such acquisitions and divestitures, whether or not ultimately consummated) is often large relative to our overall financial performance, which can adversely affect the comparability of our results on a period-to-period basis. In addition, certain activities and their underlying associated costs, such as business acquisitions, generally occur periodically but on an unpredictable basis. We calculate non-GAAP integration costs to include third-party integration costs incurred post-acquisition. Presenting revenue on a constant-currency basis allows investors to measure our revenue growth exclusive of foreign currency exchange fluctuations more clearly. Non-GAAP results also allow investors to compare the Company’s operations against the financial results of other companies in the industry who similarly provide non-GAAP results. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules and regulations. Reconciliations of the non-GAAP financial measures used in this press release to the most directly comparable GAAP financial measures are set forth in this press release, and can also be found on the Company’s website at ir.criver.com. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “intend,” “will,” “may,” “estimate,” “plan,” “outlook,” and “project,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements also include statements regarding our projected future financial performance including revenue (on both a reported, constant-currency, and organic growth basis), operating margins, earnings per share, the expected impact of foreign exchange rates, and the expected benefit of our life science venture capital investments; the future demand for drug discovery and development products and services, including our expectations for future revenue trends; our expectations with respect to the impact of acquisitions on the Company, our service offerings, client perception, strategic relationships, revenue, revenue growth rates, and earnings; the development and performance of our services and products; market and industry conditions including the outsourcing of services and spending trends by our clients; the potential outcome of and impact to our business and financial operations due to litigation and legal proceedings; and Charles River’s future performance as delineated in our forward-looking guidance, and particularly our expectations with respect to revenue, the impact of foreign exchange, and enhanced efficiency initiatives. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to: the ability to successfully integrate businesses we acquire; the ability to execute our efficiency initiatives on an effective and timely basis (including divestitures and site closures); the timing and magnitude of our share repurchases; negative trends in research and development spending, negative trends in the level of outsourced services, or other cost reduction actions by our clients; the ability to convert backlog to revenue; special interest groups; contaminations; industry trends; new displacement technologies; USDA and FDA regulations; changes in law; continued availability of products and supplies; loss of key personnel; interest rate and foreign currency exchange rate fluctuations (including the impact of Brexit); changes in tax regulation and laws; changes in generally accepted accounting principles; and any changes in business, political, or economic conditions due to the threat of future terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River's Annual Report on Form 10-K as filed on February 14, 2017, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law. Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com. (1) Charles River management believes that supplementary non-GAAP financial measures provide useful information to allow investors to gain a meaningful understanding of our core operating results and future prospects, without the effect of often-one-time charges and other items which are outside our normal operations, consistent with the manner in which management measures and forecasts the Company’s performance. The supplementary non-GAAP financial measures included are not meant to be considered superior to, or a substitute for results of operations prepared in accordance with U.S. GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules, regulations and guidance. (2) These adjustments are related to the evaluation and integration of acquisitions, which primarily include transaction, third-party integration, and certain compensation costs, and fair value adjustments associated with contingent consideration. (3) This adjustment relates to transition costs associated with the divestiture of the CDMO business. (1) Charles River management believes that supplementary non-GAAP financial measures provide useful information to allow investors to gain a meaningful understanding of our core operating results and future prospects, without the effect of often-one-time charges and other items which are outside our normal operations, consistent with the manner in which management measures and forecasts the Company’s performance. The supplementary non-GAAP financial measures included are not meant to be considered superior to, or a substitute for results of operations prepared in accordance with U.S. GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules, regulations and guidance. (1) Charles River management believes that supplementary non-GAAP financial measures provide useful information to allow investors to gain a meaningful understanding of our core operating results and future prospects, without the effect of often-one-time charges and other items which are outside our normal operations, consistent with the manner in which management measures and forecasts the Company’s performance. The supplementary non-GAAP financial measures included are not meant to be considered superior to, or a substitute for results of operations prepared in accordance with U.S. GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules, regulations and guidance. (2) The contribution from acquisitions reflects only those acquisitions which were completed during fiscal year 2016. (3) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions and foreign exchange. (1) Includes restricted cash of $2.3 million and $2.0 million as of December 31, 2016 and December 26, 2015, respectively, which are reported in current and long-term other assets within the unaudited condensed consolidated balance sheets. (2) Includes restricted cash balances of $2.3 million and $1.9 million as of April 1, 2017 and March 26 2016, respectively, which are reported in current and long-term other assets within the unaudited condensed consolidated balance sheets.


Nomanbhoy T.K.,ActivX Biosciences | Sharma G.,Agilux Laboratories | Brown H.,ActivX Biosciences | Wu J.,ActivX Biosciences | And 6 more authors.
Biochemistry | Year: 2016

Palbociclib is a cyclin-dependent kinase (CDK) 4/CDK6 inhibitor approved for breast cancer that is estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative. We profiled palbociclib in cells either sensitive or resistant to the drug using an ATP/ADP probe-based chemoproteomics platform. Palbociclib only engaged CDK4 or CDK6 in sensitive cells. In resistant cells, no inhibition of CDK4 or CDK6 was observed, although the off-target profiles were similar in both cell types. Prolonged incubation of sensitive cells with the compound (24 h) resulted in the downregulation of additional kinases, including kinases critical for cell cycle progression. This downregulation is consistent with cell cycle arrest caused by palbociclib treatment. Both the direct and indirect targets were also observed in a human tumor xenograft study using the COLO-205 cell line in which phosphorylation of the retinoblastoma protein was tracked as the pharmacodyanamic marker. Together, these results suggest that this probe-based approach could be an important strategy toward predicting patient responsiveness to palbociclib. © 2016 American Chemical Society.


The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this years closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industrys best practices and the conclusions from the discussion of these topics is included in this meeting report.


WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the fourth-quarter and full-year 2016 and provided guidance for 2017. For the quarter, revenue from continuing operations was $466.8 million, an increase of 31.9% from $353.9 million in the fourth quarter of 2015. Revenue growth was driven primarily by the Discovery and Safety Assessment and Manufacturing Support segments. Research Models and Services revenue also increased. The acquisitions of WIL Research, Agilux Laboratories, Blue Stream Laboratories, and Oncotest contributed 20.9% to consolidated fourth-quarter revenue growth, both on a reported basis and in constant currency. The addition of a 53rd week at the end of 2016, which is periodically required to align to a December 31st calendar year end, contributed approximately 5.1% to reported fourth-quarter revenue growth. The impact of foreign currency translation reduced reported revenue growth by 2.4%. Excluding the effect of these items, organic revenue growth was 8.3%. On a GAAP basis, net income from continuing operations attributable to common shareholders was $44.7 million for the fourth quarter of 2016, an increase of 36.4% from $32.8 million for the same period in 2015. Fourth-quarter diluted earnings per share on a GAAP basis were $0.93, an increase of 34.8% from $0.69 for the fourth quarter of 2015. On a non-GAAP basis, net income from continuing operations was $58.3 million for the fourth quarter of 2016, an increase of 23.3% from $47.3 million for the same period in 2015. Fourth-quarter diluted earnings per share on a non-GAAP basis were $1.21, an increase of 21.0% from $1.00 per share for the fourth quarter of 2015. Both the GAAP and non-GAAP earnings per share increases were driven primarily by the acquisition of new businesses, notably WIL Research, as well as higher revenue for legacy operations. A gain from the Company’s venture capital investments contributed $0.02 per share in the fourth quarter of 2016, compared to a negligible impact for the same period in 2015. James C. Foster, Chairman, President and Chief Executive Officer, said, “Our fourth-quarter results provided a strong finish to an exceptional year in which we met our long-term revenue goals for all of our businesses except Discovery, and our long-term operating margin targets for the three business segments. We were very pleased that three of our businesses, Safety Assessment, Microbial Solutions, and Biologics Testing Solutions, reported low-double-digit organic revenue growth for the full year. Client demand for our unique portfolio of essential products and services remained strong across each of our client segments, particularly for our biotechnology clients, who were the primary driver of our revenue growth in 2016.” “Our continued investments to broaden our early-stage portfolio, the scientific expertise of our staff, our focus on productivity and efficiency initiatives, and our ability to offer flexible partnership structures are the primary reasons that we are the partner of choice for many of our clients. Based on our view of the opportunities in 2017, we believe we will again deliver high single-digit organic revenue growth and earnings per share growth at a faster rate than revenue,” Mr. Foster concluded. Revenue for the RMS segment was $124.7 million in the fourth quarter of 2016, an increase of 9.5% from $113.8 million in the fourth quarter of 2015. Organic revenue growth was 5.7%. Revenue growth was driven primarily by higher sales of research model services, and sales of research models also increased. In the fourth quarter of 2016, the RMS segment’s GAAP operating margin increased to 26.7% from 24.1% in the fourth quarter of 2015. On a non-GAAP basis, the operating margin increased to 27.3% from 25.4% in the fourth quarter of 2015. Both the GAAP and non-GAAP operating margin increases were due primarily to higher sales volume and the benefit of efficiency initiatives. Revenue from continuing operations for the DSA segment was $241.7 million in the fourth quarter of 2016, an increase of 50.6% from $160.5 million in the fourth quarter of 2015. Growth was driven primarily by the acquisitions of WIL Research, Agilux Laboratories, and Oncotest, which contributed 41.6% to DSA revenue growth. Organic revenue growth was 7.9%. Low-double-digit growth in the legacy Safety Assessment business was partially offset by lower revenue for the legacy Discovery Services business, which declined due primarily to softer demand from global clients for Early Discovery services. Robust demand from biotechnology clients continued to drive revenue growth in the DSA segment. In the fourth quarter of 2016, the DSA segment’s GAAP operating margin declined to 18.1% from 23.1% in the fourth quarter of 2015. The margin decline was due to costs associated with the evaluation and integration of acquisitions, including amortization of intangible assets, as well as the benefit from a tax law change in Quebec in the fourth quarter of 2015. On a non-GAAP basis, the operating margin decreased to 23.8% from 27.1% in the fourth quarter of 2015, due primarily to the tax law change in Quebec, which benefited both the GAAP and non-GAAP DSA operating margin by approximately 230 basis points in the fourth quarter of 2015. The acquisition of WIL reduced the fourth-quarter operating margin by approximately 100 basis points, and foreign exchange benefited the DSA operating margin by approximately 80 basis points due primarily to a weaker British pound. Revenue for the Manufacturing segment was $100.3 million in the fourth quarter of 2016, an increase of 26.2% from $79.5 million in the fourth quarter of 2015. The acquisitions of Blue Stream Laboratories and WIL Research’s contract development and manufacturing (CDMO) services contributed 9.2% to Manufacturing revenue growth in the fourth quarter of 2016. Organic revenue growth was 12.9%, primarily driven by robust growth in the Microbial Solutions and Biologics Testing Solutions businesses. In the fourth quarter of 2016, the Manufacturing segment’s GAAP operating margin increased to 31.0% from 23.7% in the fourth quarter of 2015. The GAAP operating margin increase was primarily driven by lower acquisition costs related to Celsis, as well as leverage from higher revenue in the Microbial Solutions business. On a non-GAAP basis, the operating margin increased to 34.2% from 33.8% in the fourth quarter of 2015, driven by operating margin improvement in the Microbial Solutions business as a result of higher revenue and the benefit of efficiency initiatives. For 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015. Organic revenue growth was 7.7%. On a GAAP basis, net income from continuing operations attributable to common shareholders was $154.5 million in 2016, an increase of 2.8% from $150.3 million in 2015. Diluted earnings per share on a GAAP basis in 2016 were $3.22, an increase of 2.2% from $3.15 in 2015. On a non-GAAP basis, net income from continuing operations was $218.9 million in 2016, an increase of 22.1% from $179.3 million in 2015. Diluted earnings per share on a non-GAAP basis in 2016 were $4.56, an increase of 21.3% from $3.76 in 2015. For 2016, RMS revenue was $494.0 million, an increase of 5.0% from $470.4 million in 2015. Organic revenue growth was 4.1%. On a GAAP basis, the RMS segment operating margin increased to 27.6% in 2016 from 25.7% in 2015. On a non-GAAP basis, the operating margin increased to 28.4% in 2016 from 27.1% in 2015. For 2016, DSA revenue was $836.6 million, an increase of 36.7% from $612.2 million in 2015. Organic revenue growth was 8.9%. On a GAAP basis, the DSA segment operating margin decreased to 16.5% in 2016 from 19.9% in 2015. On a non-GAAP basis, the operating margin decreased to 22.7% in 2016 from 23.3% in 2015. For 2016, Manufacturing revenue was $350.8 million, an increase of 25.0% from $280.7 million in 2015. Organic revenue growth was 11.3%. On a GAAP basis, the Manufacturing segment operating margin increased to 29.8% in 2016 from 26.6% in 2015. On a non-GAAP basis, the operating margin increased to 33.8% in 2016 from 32.6% in 2015. Charles River completed the divestiture of its CDMO business on February 10, 2017, to Quotient Clinical, a portfolio company of specialist healthcare investment adviser GHO Capital Partners LLP, based in London, England, for $75.0 million in cash, subject to certain post-closing adjustments. The CDMO business, which represented approximately 1% of Charles River’s 2016 consolidated revenue, provides services to support the formulation design and manufacture of oral drug dosages for biopharmaceutical clients, specializing in high-potency compounds. Charles River acquired the CDMO business in April 2016 as part of the acquisition of WIL Research. Following a strategic review, Charles River determined that the CDMO business was not optimized within Charles River’s portfolio at its current scale, and that the capital could be better deployed in other long-term growth opportunities. The Company is providing the following revenue growth and earnings per share guidance for 2017. This guidance reflects the divestiture of the CDMO business. Earnings per share in 2017 are expected to benefit from both higher revenue and operating margin expansion. The benefit is expected to be partially offset by foreign exchange, which is expected to reduce 2017 earnings per share by approximately $0.10, and lower gains from the Company’s venture capital investments. The Company’s 2016 earnings per share included a $0.13 gain on venture capital investments, and 2017 guidance includes an estimated $0.04 gain on these investments, consistent with the Company’s expected return on invested capital. Footnotes to Guidance Table (1) The contribution from acquisitions reflects only those acquisitions which were completed in 2016. (2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions, the divestiture of the CDMO business, the 53rd week, and foreign currency translation. (3) GAAP earnings per share guidance does not include the expected net gain and tax impact related to the divestiture of the CDMO business because the disposition accounting has not yet been finalized. (4) These charges relate primarily to the Company’s planned efficiency initiatives in 2017, including site consolidation costs, asset impairments, and severance. Other projects in support of the global productivity and efficiency initiatives are expected, but these charges reflect only the decisions that have already been finalized. (5) These adjustments are related to the evaluation and integration of acquisitions and the divestiture of the CDMO business, and primarily include transaction, advisory, and certain third-party integration costs, as well as certain costs associated with acquisition-related efficiency initiatives. Charles River has scheduled a live webcast on Tuesday, February 14, at 8:00 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website. Charles River will present at the Leerink 6th Annual Global Healthcare Conference in New York on Thursday, February 16, at 9:30 a.m. ET. Management will provide an overview of Charles River’s strategic focus and business developments. A live webcast of the presentation will be available through a link that will be posted on the Investor Relations section of the Charles River website at ir.criver.com. A webcast replay will be accessible through the same website approximately three hours after the presentation and will remain available for approximately two weeks. The Company reports non-GAAP results in this press release, which exclude often one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release. In addition, the Company reports results from continuing operations, which exclude results of the Phase I clinical business that was divested in 2011. The Phase I business is reported as a discontinued operation. Use of Non-GAAP Financial Measures This press release contains non-GAAP financial measures, such as non-GAAP earnings per diluted share, which exclude the amortization of intangible assets, inventory purchase accounting adjustments, and other charges related to our acquisitions; expenses associated with evaluating and integrating acquisitions and divestitures, as well as fair value adjustments associated with contingent consideration; charges related to modifications of purchase options on remaining non-controlled equity interests, and re-measurement of previously held equity interests; charges, gains and losses attributable to businesses or properties we plan to close, consolidate or divest; severance and other costs associated with our efficiency initiatives; executive transition costs; a reversal of indemnification assets associated with acquisitions and corresponding interest; write-off of and adjustments to deferred financing costs and fees related to debt financing; gain on bargain purchase; and costs related to a U.S. government billing adjustment and related expenses. This press release also refers to our revenue in both a GAAP and non-GAAP basis: “constant currency,” which we define as reported revenue growth adjusted for the impact of foreign currency translation, and “organic revenue growth,” which we define as reported revenue growth adjusted for foreign currency translation, acquisitions, the divestiture of the CDMO business, and the 53rd week. We exclude these items from the non-GAAP financial measures because they are outside our normal operations. There are limitations in using non-GAAP financial measures, as they are not prepared in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. In particular, we believe that the inclusion of supplementary non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of our core operating results and future prospects without the effect of these often-one-time charges, and is consistent with how management measures and forecasts the Company's performance, especially when comparing such results to prior periods or forecasts. We believe that the financial impact of our acquisitions and divestitures (and in certain cases, the evaluation of such acquisitions and divestitures, whether or not ultimately consummated) is often large relative to our overall financial performance, which can adversely affect the comparability of our results on a period-to-period basis. In addition, certain activities and their underlying associated costs, such as business acquisitions, generally occur periodically but on an unpredictable basis. We calculate non-GAAP integration costs to include third-party integration costs incurred post-acquisition. Presenting revenue on a constant-currency basis allows investors to measure our revenue growth exclusive of foreign currency exchange fluctuations more clearly. Non-GAAP results also allow investors to compare the Company’s operations against the financial results of other companies in the industry who similarly provide non-GAAP results. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules and regulations. Reconciliations of the non-GAAP financial measures used in this press release to the most directly comparable GAAP financial measures are set forth in this press release, and can also be found on the Company’s website at ir.criver.com. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “intend,” “will,” “may,” “estimate,” “plan,” “outlook,” and “project,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements also include statements regarding our projected future financial performance including revenue (on both a reported, constant-currency, and organic growth basis), operating margins, earnings per share, the expected impact of foreign exchange rates, and the expected benefit of our life science venture capital investments; the future demand for drug discovery and development products and services, including our expectations for future revenue trends; our expectations with respect to the impact of acquisitions on the Company, our service offerings, client perception, strategic relationships, revenue, revenue growth rates, and earnings; the development and performance of our services and products; market and industry conditions including the outsourcing of services and spending trends by our clients; the potential outcome of and impact to our business and financial operations due to litigation and legal proceedings, including with respect to our ongoing investigation of inaccurate billing with respect to certain government contracts; and Charles River’s future performance as delineated in our forward-looking guidance, and particularly our expectations with respect to revenue, the impact of foreign exchange, and enhanced efficiency initiatives. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to: the ability to successfully integrate businesses we acquire; the ability to execute our efficiency initiatives on an effective and timely basis (including divestitures and site closures); the timing and magnitude of our share repurchases; negative trends in research and development spending, negative trends in the level of outsourced services, or other cost reduction actions by our clients; the ability to convert backlog to revenue; special interest groups; contaminations; industry trends; new displacement technologies; USDA and FDA regulations; changes in law; continued availability of products and supplies; loss of key personnel; interest rate and foreign currency exchange rate fluctuations (including the impact of Brexit); changes in tax regulation and laws; changes in generally accepted accounting principles; and any changes in business, political, or economic conditions due to the threat of future terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River's Annual Report on Form 10-K as filed on February 12, 2016, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law. Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com. (1) Charles River management believes that supplementary non-GAAP financial measures provide useful information to allow investors to gain a meaningful understanding of our core operating results and future prospects, without the effect of often-one-time charges and other items which are outside our normal operations, consistent with the manner in which management measures and forecasts the Company’s performance. The supplementary non-GAAP financial measures included are not meant to be considered superior to, or a substitute for results of operations prepared in accordance with U.S. GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules, regulations and guidance. (2) This item includes operating losses related primarily to the Company's Shrewsbury, Massachusetts facility. (3) These adjustments are related to the evaluation and integration of acquisitions, which primarily include transaction, third-party integration, and certain compensation costs, and fair value adjustments associated with contingent consideration. (1) Charles River management believes that supplementary non-GAAP financial measures provide useful information to allow investors to gain a meaningful understanding of our core operating results and future prospects, without the effect of often-one-time charges and other items which are outside our normal operations, consistent with the manner in which management measures and forecasts the Company’s performance. The supplementary non-GAAP financial measures included are not meant to be considered superior to, or a substitute for results of operations prepared in accordance with U.S. GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules, regulations and guidance. (2) These amounts represent the reversal of an uncertain tax position and an offsetting indemnification asset primarily related to the acquisition of BioFocus. (3) The amounts relate to the acquisition of Sunrise Farms, Inc. and represents the excess of the estimated fair value of the net assets acquired over the purchase price. (4) The amount represents a $1.5 million charge recorded in connection with the modification of the option to purchase the remaining 13% equity interest in Vital River, partially offset by a $0.7 million gain on remeasurement of previously held equity interest in an entity acquired in a step acquisition. (1) Charles River management believes that supplementary non-GAAP financial measures provide useful information to allow investors to gain a meaningful understanding of our core operating results and future prospects, without the effect of often-one-time charges and other items which are outside our normal operations, consistent with the manner in which management measures and forecasts the Company’s performance. The supplementary non-GAAP financial measures included are not meant to be considered superior to, or a substitute for results of operations prepared in accordance with U.S. GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules, regulations and guidance. (2) The contribution from acquisitions reflects only those acquisitions which were completed during fiscal year 2016 and 2015. (3) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions, the 53rd week, and foreign exchange.


Woolf E.J.,Merck And Co. | McDougall S.,Covance | Fast D.M.,Covance Laboratories Inc. | Andraus M.,ChromAnalysis | And 27 more authors.
AAPS Journal | Year: 2014

Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance. © 2014 American Association of Pharmaceutical Scientists.

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