Albany, NY, United States
Albany, NY, United States

Time filter

Source Type

ALBANY, New York, Feb. 21, 2017 /PRNewswire/ -- AMRI (NASDAQ: AMRI) today announced that it has entered into an agreement with the pharmaceutical group Ferrer and Accord Healthcare, Inc. ("Accord Healthcare") to jointly develop and manufacture an undisclosed complex parenteral drug product for registration and subsequent commercialization in the United States with the option to partner on additional drug products. Under terms of the agreement, AMRI will work with Ferrer to develop and initially provide cGMP manufacturing and analytical support for the registration of the new product. Accord Healthcare will be responsible for advancing the product candidate through regulatory submission and commercialization. William S. Marth, president and CEO, said, "As one of the fastest growing generic companies in the United States, AMRI is very impressed with Accord's performance and excited to be able to extend our deep scientific and product development expertise to help the company advance this product towards the market. Strategic partnerships, such as this agreement with Accord Healthcare, are just one example of how we can help biopharmaceutical companies enhance the value of their innovation and accelerate development and manufacturing, and at the same time we gain access to the benefits of the end market sales of the developed product when they become commercially available." Gerald Price, president of Accord Healthcare US and Canada, said, "AMRI brings unique capabilities and experience to drug development and manufacturing. We look forward to working with AMRI and Ferrer to leverage the companies' complementary expertise and abilities to address the unique challenges involved in complex drug product development and manufacturing." Ernest Domenech, COO of Ferrer HealthTech, said, "This agreement with Accord and AMRI provides an excellent opportunity to enter the US market with this product. We are convinced that Ferrer's expertise in the manufacturing of high quality generic drugs combined with the expertise of AMRI and Accord Healthcare will ensure the success of this project in the United States." About AMRI 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. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal). About Accord Healthcare, Inc. As part of the Intas Group, Accord Healthcare is a young and dynamic pharmaceutical company, involved in the development, manufacturing and distribution of pharmaceutical products to over 70 markets around the world. Accord Healthcare has very rapidly become one of the fastest growing generic pharmaceutical companies with a robust product portfolio in growth oriented therapies, such as Oncology, Immunosuppression, Cardiovascular and Central Nervous System and over 7000 market authorizations (as of December 2016) in various markets. Additional information is available on the company's website atwww.accordhealthcare.us. About Ferrer Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company, with full vertical integration from R&D to distribution. It is present in more than 95 countries, with 24 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people's health and quality of life. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics. Visit www.ferrer.com. Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "may," "intends," "anticipate(s)," "plan," "enables," "potentially," "expects," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, but are not limited to: statements regarding expected future performance of each of AMRI, Ferrer and Accord under the agreement; the parties' ability to work effectively together; statements regarding potential FDA approval; statements made by the CEOs of AMRI and Accord; successful compliance with FDA and other applicable governmental regulations; and the ability of the company's strategic collaborations to perform as expected. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond AMRI's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to: whether AMRI, Ferrer and Accord will successfully perform each of their respective obligations under the agreement; whether the FDA will ultimately approve the product candidate or candidates developed under the agreement; as well as those risks that are discussed in AMRI's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 as filed with the U.S. Securities and Exchange Commission on March 30, 2016, its subsequent Quarterly Reports on Form 10-Q and its other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.


ALBANY, N.Y., Feb. 21, 2017 /PRNewswire/ -- AMRI (NASDAQ: AMRI) today announced that it has entered into an agreement with the pharmaceutical group Ferrer  and Accord Healthcare, Inc. ("Accord Healthcare") to jointly develop and manufacture an undisclosed complex parenteral drug produ...


CARY, NC--(Marketwired - February 08, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Drug Product Contract Manufacturer Quality Benchmarking report reveals that buyers of outsourced drug product manufacturing services value a strong regulatory history and reliable on-time delivery more than low cost when selecting a CMO for drug product manufacturing. The report includes information on respondents' outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the drug product offerings of 70 contract manufacturing organizations. 302 respondents provide rating assessments on 673 service encounters. "A strong regulatory track record topped the list of attributes as the most important factor influencing drug product CMO selection," said Kate Hammeke, Vice President, Market Research at Industry Standard Research. "Reliable on-time delivery placed second and a track record for meeting quality performance metrics came in third. Low cost had fewer than one-in-ten respondents mention it as the most important selection driver. We are hearing this more and more from service buyers. Cost is not necessarily becoming less important, but that multiple factors beyond project price impact overall costs and consequently those attributes outweigh 'low cost' as a selection criterion." The report provides a Consumer Reports-style analysis where each of the 70 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for drug product manufacturing projects. There are several stand-out CMOs this year: Pfizer CentreOne placed among the leaders across each of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics) and Samsung BioLogics received top scores for its Organization Factors and Capabilities. Fareva received top marks for its Delivery Factors and among emerging market CMOs, Wuxi AppTec appeared among the leaders for its Organization Factors. CMO performance attributes evaluated by respondents include Full range of manufacturing for the dosage forms we require, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 20 of the 70 featured contract manufacturers, including AbbVie Contract Manufacturing, Albany Molecular Research Inc. (AMRI), Almac, Baxter BioPharma Solutions, Boehringer Ingelheim, Capsugel, Catalent, Dr. Reddy's CPS, Evonik, Fareva, GSK Contract Manufacturing, Patheon, PCI Pharma Services, Pfizer CentreOne, Piramal Pharma Solutions, Samsung BioLogics, Sandoz, Sanofi CEPiA, Vetter and Wuxi AppTec. For more information on ISR's "Drug Product Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/drug-product-contract-manufacturer-quality-benchmarking-2nd-edition/. Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


News Article | February 21, 2017
Site: www.businesswire.com

SEATTLE--(BUSINESS WIRE)--Nativis Inc., a clinical stage life science bio-electronic company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, today announced that Dr. Una Ryan has been appointed to its board of directors effective immediately. Ryan is a biologist and seasoned healthcare executive with extensive experience serving on the boards of public, private and non-profit companies. She is currently a limited partner at Breakout Ventures, Managing Director of Golden Seeds, an investment firm empowering women entrepreneurs, and a partner in Astia Angel, investing in women-led ventures. Ryan currently serves on the boards of AMRI, a global contract research and manufacturing company and RenovoRx, a medical device company. She was previously the President and CEO at Diagnostics for All, Inc., a developer of inexpensive diagnostic tools for global health and agriculture; Waltham Technologies, a cleantech start-up; and AVANT Immunotherapeutics Inc. (now Celldex), a company developing vaccines for cancer and global health. Throughout her career, Ryan has successfully translated science into successful businesses, driving growth and overseeing multiple M&A’s in order to create robust and diverse organizations. Ryan spent more than 20 years as a Professor of Medicine at the University of Miami, Washington University, St. Louis and Boston University where she conducted research on vascular biology. She holds a Ph.D. in Cellular and Molecular Biology from Cambridge University and BS degrees in Zoology, Microbiology and Chemistry from Bristol University. She received an Honorary Doctor of Science degree from Bristol University in 2009. “We are thrilled to be able to continue to diversify our board of directors and welcome Una, a distinguished entrepreneur, biologist and healthcare executive,” said Nativis CEO Chris Rivera. “Una brings a broad range of experience in the life science and investment arenas to the board, and her insight will be of great value to Nativis as we continue to develop and seek long term partners for of our novel ulRFE technology. Una’s background in global health and developing medical technologies adds significantly to the diversity of our other Directors’ extensive industry experience, which includes, for example; cyber-security, disruptive technologies, financial management, venture capital and bio-pharmaceutical development.” Ryan added, “I am excited to join the Nativis team, and look forward to helping guide the company through the development of its unique technology platform. Nativis’ ulRFE technology represents an unprecedented opportunity to advance a new wave of treatment for recurrent glioblastoma multiforme and other health care indications, and I believe that with the right resources and strategies, the company can position itself for future success.” Founded in 2002 and headquartered in Seattle, WA, Nativis is a clinical-stage bio-electronics company. Nativis has invented and patented a groundbreaking technology that utilizes precisely targeted, ultra-low radio frequency energy (ulRFE™) to specifically regulate metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-invasive device called Nativis Voyager®. The company’s goal is to transform disease treatment on a global scale with ulRFE that can potentially be applied to a wide range of conditions and other health-related needs (including agriculture, bio-fuels and veterinary medicine, to name a few). Nativis’ initial focus is on the treatment of patients with brain cancer (initially, recurrent glioblastoma), who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Additional pre-clinical work is being completed for melanoma, lung cancer, liver cancer, inflammatory disease and chronic pain.


This report studies Drug Discovery Outsourcing in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with capacity, production, price, revenue and market share for each manufacturer, covering Request a Sample Report @ https://www.wiseguyreports.com/sample-request/963107-global-drug-discovery-outsourcing-market-research-report-2017 Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Drug Discovery Outsourcing in these regions, from 2011 to 2021 (forecast), like North America Europe China Japan Southeast Asia India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into Libraries Building Blocks Compound Synthesis Target Validation Split by application, this report focuses on consumption, market share and growth rate of Drug Discovery Outsourcing in each application, can be divided into Chemistry Services Biology Services Lead Optimisation Lead Identification and Screening Global Drug Discovery Outsourcing Market Research Report 2017 1 Drug Discovery Outsourcing Market Overview 1.1 Product Overview and Scope of Drug Discovery Outsourcing 1.2 Drug Discovery Outsourcing Segment by Type 1.2.1 Global Production Market Share of Drug Discovery Outsourcing by Type in 2015 1.2.2 Libraries 1.2.3 Building Blocks 1.2.4 Compound Synthesis 1.2.5 Target Validation 1.3 Drug Discovery Outsourcing Segment by Application 1.3.1 Drug Discovery Outsourcing Consumption Market Share by Application in 2015 1.3.2 Chemistry Services 1.3.3 Biology Services 1.3.4 Lead Optimisation 1.3.5 Lead Identification and Screening 1.4 Drug Discovery Outsourcing Market by Region 1.4.1 North America Status and Prospect (2012-2022) 1.4.2 Europe Status and Prospect (2012-2022) 1.4.3 China Status and Prospect (2012-2022) 1.4.4 Japan Status and Prospect (2012-2022) 1.4.5 Southeast Asia Status and Prospect (2012-2022) 1.4.6 India Status and Prospect (2012-2022) 1.5 Global Market Size (Value) of Drug Discovery Outsourcing (2012-2022) 7 Global Drug Discovery Outsourcing Manufacturers Profiles/Analysis 7.1 Albany Mlecular Research (AMRI) 7.1.1 Company Basic Information, Manufacturing Base and Its Competitors 7.1.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.1.2.1 Libraries 7.1.2.2 Building Blocks 7.1.3 Albany Mlecular Research (AMRI) Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.1.4 Main Business/Business Overview 7.2 Aptuit 7.2.1 Company Basic Information, Manufacturing Base and Its Competitors 7.2.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.2.2.1 Libraries 7.2.2.2 Building Blocks 7.2.3 Aptuit Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.2.4 Main Business/Business Overview 7.3 Charles River Labratries 7.3.1 Company Basic Information, Manufacturing Base and Its Competitors 7.3.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.3.2.1 Libraries 7.3.2.2 Building Blocks 7.3.3 Charles River Labratries Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.3.4 Main Business/Business Overview 7.4 Cvance 7.4.1 Company Basic Information, Manufacturing Base and Its Competitors 7.4.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.4.2.1 Libraries 7.4.2.2 Building Blocks 7.4.3 Cvance Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.4.4 Main Business/Business Overview 7.5 Cyprtex 7.5.1 Company Basic Information, Manufacturing Base and Its Competitors 7.5.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.5.2.1 Libraries 7.5.2.2 Building Blocks 7.5.3 Cyprtex Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.5.4 Main Business/Business Overview 7.6 Dmainex 7.6.1 Company Basic Information, Manufacturing Base and Its Competitors 7.6.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.6.2.1 Libraries 7.6.2.2 Building Blocks 7.6.3 Dmainex Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.6.4 Main Business/Business Overview 7.7 Evtec 7.7.1 Company Basic Information, Manufacturing Base and Its Competitors 7.7.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.7.2.1 Libraries 7.7.2.2 Building Blocks 7.7.3 Evtec Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.7.4 Main Business/Business Overview 7.8 GenScript 7.8.1 Company Basic Information, Manufacturing Base and Its Competitors 7.8.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.8.2.1 Libraries 7.8.2.2 Building Blocks 7.8.3 GenScript Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.8.4 Main Business/Business Overview 7.9 Pharmaceutical Prduct Develpment (PPD) 7.9.1 Company Basic Information, Manufacturing Base and Its Competitors 7.9.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.9.2.1 Libraries 7.9.2.2 Building Blocks 7.9.3 Pharmaceutical Prduct Develpment (PPD) Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.9.4 Main Business/Business Overview 7.10 Quintiles 7.10.1 Company Basic Information, Manufacturing Base and Its Competitors 7.10.2 Drug Discovery Outsourcing Product Type, Application and Specification 7.10.2.1 Libraries 7.10.2.2 Building Blocks 7.10.3 Quintiles Drug Discovery Outsourcing Production, Revenue, Price and Gross Margin (2015 and 2016) 7.10.4 Main Business/Business Overview 7.11 Selcia 7.12 Viva Bitech 7.13 WIL Research Labratries 7.14 WuXi AppTec For more information, please visit https://www.wiseguyreports.com/sample-request/963107-global-drug-discovery-outsourcing-market-research-report-2017


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.


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

CARY, NC--(Marketwired - February 09, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Small Molecule API Contract Manufacturer Quality Benchmarking report reveals that the top performing CMOs relative to expectations, and based off customer feedback on recent service encounters, are contract manufacturers with a drug innovator as its parent company. "For the second year in a row, Pfizer CentreOne has been a top performer across all four scorecards," explained Kate Hammeke. "This year, AbbVie Contract Manufacturing placed among the leaders in three of the four scorecards. This is a sign that customers working with embedded CMOs are having their expectations exceeded, but so are respondents who outsource to small and midsize CMOs. Aesica, SAI Life Sciences and Wockhardt received top marks across two scorecards each, which is a sign that regardless of project size or company budget, one can find a CMO whose quality matches your organization's needs." The report includes information on buyers' outsourcing philosophies and practices, CMO perceptions and interactions, and CMO selection drivers before diving into a series of in-depth performance analyses specific to the small molecule offerings of 36 contract manufacturing organizations. 241 respondents provide rating assessments on 689 service encounters. The report provides a Consumer Reports-style analysis where each of the 36 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for small molecule projects from early clinical stages to commercialization. CMO performance attributes evaluated by respondents include Ability to manufacture small molecule API, Reliable on-time delivery, Regulatory history, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 27 of the 36 featured contract manufacturers, including AbbVie Contract Manufacturing, Aesica, Albany Molecular Research Inc. (AMRI), Alcami, Almac, AMPAC Fine Chemicals, Aptuit, Ash Stevens, Cambrex, Dr. Reddy's CPS, Evonik, GSK Contract Manufacturing, Halo Pharma, Lonza, Novasep, Patheon, Pfizer CentreOne, PharmaCore, Piramal Pharma Solutions, Recipharm, SAFC, SAI Life Sciences, Sanofi CEPiA, Siegfried, Wockhardt and Wuxi AppTec. For more information on ISR's "Small Molecule API Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/small-molecule-api-contract-manufacturer-quality-benchmarking-2nd-edition/ Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


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

SSCI, a division of Albany Molecular Research, Inc. is pleased to announce that the next revision of its web site (http://www.ssci-inc.com/ ) has been launched with features intended to improve the functionality for client contact. Over the past two years, SSCI has made a strong financial and personnel commitment to improve its online presence. This newest version of the web site features a “Let’s Get Started!” application that brings together all the ways that current and potential clients can contact SSCI for industry leading solid state and analytical services, and a “KnowledgeBase” intended to organize our recent publications, social posts, and application notes, making it easily accessible and shareable with the people that need it most. In addition, clients are able to receive immediate and detailed service information specific to their area of interest and services required. This further decreases the time from the time a request is submitted to the delivery of a high-quality, data driven report or a proposal for research services. Online inquiries are directed to our technical directors to insure same-day response and a client experience, unmatched in the services industry. “We have made a commitment to implement technology that assists clients in a direct and immediate manner via the internet,” commented David A. Engers, PhD, Senior Director and Site Head at SSCI. “The tools that we are building online help our current and potential clients by providing a plethora of useful information with just a few key strokes. The response and feedback we have received for these programs has been nothing short of positive.” In addition to the current web site updates, SSCI will continue to offer informative educational materials on all key areas of solid state and analytical services, including the continuation of our legacy for hosting short courses and special topics webinars. About SSCI SSCI, a division of Albany Molecular Research Inc., provides industry leading contract solid-state and analytical testing services and exists to help companies in the pharmaceutical, food, agrochemical, and other chemical industries develop better products and get them to market more quickly. Over the past quarter century, SSCI has provided comprehensive cGMP research and analytical services in the characterization and chemistry of solid materials, with particular expertise in small and large molecules being investigated for pharmaceutical use. As the AMRI’s Center of Excellence for Solid State Chemistry, its offerings include early candidate support services (in vitro analysis, stability, solubility, dissolution, excipient compatibility), solid form screening and polymorph, salt and cocrystal screening, form selection, particle engineering (process development, particle size method development), property improvement, crystallization of difficult materials, process control, biochemical analysis, full analytical chemistry support including method development and validation, intellectual property consulting and litigation support, and related research activities. For more information about SSCI’s solid-state and analytical chemistry services, please contact 1-800-375-2179 | http://www.ssci-inc.com.


Cioffi C.L.,AMRI
Bioorganic and Medicinal Chemistry Letters | Year: 2013

Schizophrenia is a devastating mental illness that afflicts nearly 1% of the world's population. Currently available antipsychotics treat positive symptoms, but are largely ineffective at addressing negative symptoms and cognitive dysfunction. Thus, improved pharmacotherapies that treat all aspects of the disease remain a critical unmet need. There is mounting evidence that links NMDA receptor hypofunction and the expression of schizophrenia, and numerous drug discovery programs have developed agents that directly or indirectly potentiate NMDA receptor-mediated neurotransmission. Several compounds have emerged that show promise for treating all symptom sub-domains in both preclinical models and clinical studies, and we will review recent developments in many of these areas. © 2013 Elsevier Ltd. All rights reserved.


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

ALBANY, N.Y., 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. Highlights: Fourth quarter total revenue of $191.3 million, up 51%...

Loading AMRI collaborators
Loading AMRI collaborators