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By: Mary L. Wagner, PharmD, MS
- Associate Professor, Department of Pharmacy Practice, Ernest Mario School of Pharmacy, Rutgers, State University of New Jersey, Piscataway, New Jersey
Cardiovascular Interventional Cardiology Our Interventional Cardiology business develops and manufactures technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders including structural heart conditions diabetes diet delivery order 30 mg actos fast delivery. Our broad diabetic diet for kids cheap 30mg actos mastercard, innovative product offerings have led to blood glucose pregnancy normal range trusted 30mg actos our leadership in the global interventional cardiology market diabetic diet recipes to lose weight purchase actos 15mg fast delivery. Drug-Eluting Coronary Stent Systems Our drug-eluting coronary stent product offerings are an important element of our global Interventional Cardiology market leadership. We believe we have enhanced the outcomes associated with the use of coronary stents, particularly the processes that lead to restenosis (the growth of neointimal tissue within an artery after angioplasty and stenting), through our scientific research and product development of drug-eluting stent systems. The iLab Ultrasound Imaging System has been placed in cardiology labs worldwide and provides an installed base through which we expect to continue to sell associated single-use products. Structural Heart Therapies Structural heart therapy is one of the fastest growing areas of the medical technology market and is highly synergistic with our Interventional Cardiology and Rhythm Management businesses. It is an investigational device within our structural heart portfolio and is not currently commercially available. Our broad peripheral product offerings include products to treat arterial diseases (stents, balloon catheters, wires and atherectomy) and venous diseases (thrombectomy, wires and stents) and employ interventional oncology techniques to treat various cancers (peripheral embolization devices, microcatheters and drainage catheters). We also offer products designed to treat patients with non-vascular disease, primarily in interventional oncology. On January 24, 2019, Bidco made such offer on the terms and subject to the conditions of the scheme document published on the same date. Refer to Note E Borrowings and Credit Arrangements to our consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data of this Annual Report for further details of the Bridge Facility. Research and Development Our investment in research and development is critical to driving our future growth. Our investment in research and development supports the following: · · internal research and development programs, regulatory design and clinical science, as well as other programs obtained through our strategic acquisitions and alliances and engineering efforts that incorporate customer feedback into continuous improvement efforts for currently marketed and next-generation products. We have directed our development efforts toward innovative technologies designed to expand current markets or enter adjacent markets. We are transforming how we conduct research and development and are scrutinizing our cost structure, which we believe will enable increased development activity and faster concept-to-market timelines. Focused, cross-functional teams take a formal approach to new product design and development, helping us to manufacture and offer innovative products consistently and efficiently. Involving cross-functional teams early in the process is the cornerstone of our product development cycle. We believe this collaboration allows our teams to concentrate resources on the most viable and clinically relevant new products and technologies and maximize cost and time savings as we bring them to market. In addition to internal development, we work with hundreds of leading research institutions, universities and clinicians around the world to develop, evaluate and clinically test our products. We are expanding our collaborations to include research and development teams in emerging markets; these teams will focus on both global and local market requirements at a lower cost of development. Marketing and Sales In 2018, we marketed our products and solutions to approximately 35,000 hospitals, clinics, outpatient facilities and medical offices in the U. The majority of our net sales are derived from countries in which we have direct sales organizations. We also have a network of distributors and dealers who offer our products in certain countries and markets. We expect to continue to leverage our infrastructure in markets where commercially appropriate and use third party distributors in those markets where it is not economical or strategic to establish or maintain a direct presence. No single institution accounted for more than ten percent of our net sales in 2018, 2017 or 2016; however, large group purchasing organizations, hospital networks and other buying groups have become increasingly important to our business and represent a substantial portion of our net sales. We consistently strive to understand and exceed the expectations of our customers. Each of our businesses maintains dedicated sales forces and marketing teams focused on physicians who specialize in the diagnosis and treatment of different medical conditions, as well as on key hospital service line administrators. We believe that this dual focus on disease state management and hospital administrators enables us to develop highly knowledgeable and dedicated sales representatives and to foster collaborative relationships with both physicians and key service line administrators. International Operations International net sales accounted for 44 percent of our net sales in 2018 and 43 percent of our net sales in both 2017 and 2016. Maintaining and expanding our international presence is an important component of our long-term growth strategy.
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The accounting for changes in the fair value of a derivative instrument depends on whether it qualifies for blood glucose under 100 trusted actos 15mg, and has been designated as part of a hedging relationship diabetes test of 6.2 actos 15mg without a prescription, as well as on the type of hedging relationship diabetes type 2 blurred vision actos 30mg overnight delivery. Our derivative instruments do not subject our earnings to blood sugar units of measure purchase actos 15mg without prescription material risk, as gains and losses on these derivatives generally offset gains and losses on the item being hedged. Refer to Note D Hedging Activities and Fair Value Measurements for more information on our derivative instruments. Shipping and Handling Costs We generally do not bill customers for shipping and handling of our products. We treat shipping and handling costs incurred after a customer obtains control of the good as a fulfillment cost and record in Selling, general and administrative expenses in our consolidated statements of operations. Shipping and handling costs were $124 million in 2018, $110 million in 2017 and $101 million in 2016. Research and Development We expense research and development costs, including new product development programs, regulatory compliance and clinical research as incurred. Potential common stock equivalents are determined using the treasury stock method. We exclude stock options and stock awards whose effect would be anti-dilutive from the calculation. We do not present pro forma financial information for these acquisitions given their results are not material to our consolidated financial statements. Transaction costs associated with these acquisitions were expensed as incurred and are not material for 2018, 2017 and 2016. Refer to Note E Borrowings and Credit Arrangements for further details of the Bridge Facility. On January 29, 2019, we announced the closing of our acquisition of Millipede, Inc. We have been an investor in Millipede since the first quarter of 2018 as part of an investment and acquisition option agreement, whereby we purchased a portion of the outstanding shares of Millipede along with newly issued shares of the company for an upfront cash payment of $90 million. In the fourth quarter of 2018, upon the recent successful completion of a first-in-human clinical study, we exercised our option to acquire the remaining shares of Millipede. We held an interest of approximately 20 percent immediately prior to the acquisition date. The transaction price for the remaining stake consists of an upfront cash payment of $325 million and up to an additional $125 million payment upon achievement of a commercial milestone. Our initial accounting for Millipede will be completed in the first quarter of 2019, and as such, the purchase price allocation in the aggregated disclosures below excludes Millipede. On October 16, 2018, we announced the closing of our acquisition of Augmenix, Inc. The transaction price consists of an upfront cash payment of $500 million and up to $100 million in payments contingent upon revenue-based milestones. On August 2, 2018, we announced the closing of our acquisition of Claret Medical, Inc. The transaction price consists of an upfront cash payment of $220 million and an additional $50 million payment for reaching a reimbursement-based milestone that was achieved in the third quarter. On July 5, 2018, we announced the closing of our acquisition of Cryterion Medical, Inc. We have been an investor in Cryterion since 2016 and held an interest of approximately 35 percent immediately prior to the acquisition date. The transaction price to acquire the remaining stake consists of an upfront cash payment of $202 million. The transaction price to acquire the remaining stake consists of an upfront cash payment of approximately $240 million and up to approximately $85 million in commercial-based milestones. The transaction price consists of an upfront cash payment of $150 million and up to approximately $125 million in payments contingent upon clinical and commercial-based milestones. In addition, we completed other individually immaterial acquisitions in 2018 for total consideration of $158 million in cash at closing plus aggregate contingent consideration of up to $62 million. We recorded gains of $184 million in 2018 within Other, net on our consolidated statements of operations based on the difference between the book values and the fair values of our previously-held investments immediately prior to the acquisition dates, which aggregate to $251 million. We re-measured the fair value of each previously-held investment based on the implied enterprise value and allocation of purchase price consideration according to priority of equity interests. On October 11, 2017, we announced the closing of our acquisition of Apama Medical Inc. The transaction price consisted of an upfront cash payment of approximately $175 million and up to approximately $125 million in payments contingent upon clinical and regulatory milestones.
In addition blood sugar 45 mg actos otc, we are investing in infrastructure in emerging markets to diabetes games generic 15 mg actos amex strengthen our sales and service capabilities and maximize our opportunities in these countries diabetes insipidus nclex buy 30 mg actos amex. As of December 31 diabetes test blood actos 15mg without prescription, 2018, we had nine principal international manufacturing facilities, including three in Ireland, two in Costa Rica, one in Brazil, one in Malaysia, one in Puerto Rico and one in Switzerland. Approximately 45 percent of our products 9 manufactured in 2018 were produced at these facilities. We also maintain research and development capabilities in China, Costa Rica, Germany, India, Ireland and Puerto Rico. We operate physician training centers in China, France, Germany, India, Italy, Japan, Poland, South Africa and South Korea. Manufacturing and Raw Materials We are focused on continuously improving our supply chain effectiveness, strengthening our manufacturing processes and increasing operational efficiencies within our organization. We strive to improve the efficiency of our sourcing operations and to leverage the technical expertise of the broader market by partnering with strategic suppliers. In doing so, we seek to focus our internal resources on the development and commercial launch of new products and the enhancement of existing products. We continue to implement new systems designed to provide improved quality, reliability, service, greater efficiency and lower supply chain costs. We also drive continuous improvement in product quality through process controls and validations, supplier and distribution controls and providing our operations teams with the necessary training and tools. In addition, we remain focused on examining our operations and general business activities to enhance our operational effectiveness by identifying cost-improvement opportunities. We remain committed to maintaining prudent investments in supply chain resiliency on an ongoing basis. Our products are designed and manufactured in technology centers around the world, either by us or third parties. We consistently monitor our inventory levels, manufacturing and distribution capabilities and maintain recovery plans to address potential disruptions that we may encounter. Many components used in the manufacturing of our products are readily fabricated from commonly available raw materials or off-the-shelf items available from multiple supply sources; however, certain items are custom made to meet our specifications. We believe that in most cases, redundant capacity exists at our suppliers and that alternative sources of supply are available or could be developed within a reasonable period of time. We also have an ongoing program to identify single-source components and to develop alternative back-up supplies and we regularly readdress the adequacy and abilities of our suppliers to meet our needs. Quality Assurance We are committed to providing high quality products to our customers. Our quality system starts with the initial product specification and continues through the design of the product, component specification process and the manufacturing, sale and servicing of the product. Our quality system is intended to build in quality and process control and to utilize continuous improvement concepts throughout the product life. Maintenance of the certification requires that these facilities undergo periodic re-examination. Environmental Regulation and Management We are subject to various environmental laws, directives and regulations both in the U. Our operations involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. We believe that sound environmental, health and safety performance contributes to our competitive strength while benefiting our customers, stockholders and employees. We are focused on continuous improvement in these areas by reducing pollution, depletion of natural resources and our overall environmental footprint. Specifically, we are working to optimize energy and resource usage, ultimately reducing greenhouse gas emissions and waste. This listing recognizes our dedication to those standards and it places us in a select group of companies with a demonstrated commitment to responsible business practices and sound environmental policies. Using this environmental management system and the specific attributes of our certified locations in the U. Our primary competitors include Abbott Laboratories, Medtronic plc and Cook Medical, as well as a wide range of medical device companies that sell a single or limited number of competitive products or participate in only a specific market segment. We also face competition from nonmedical device companies, such as pharmaceutical companies, which may offer alternative therapies for disease states that could also be treated using our products. We believe that our products and solutions compete primarily on their ability to deliver both clinical and economic outcomes for our customers while also continuing to perform diagnostic and therapeutic procedures safely and effectively in a less-invasive manner.
Cortical and subcortical deficits are associated with an increased risk for seizures diabetes mellitus type 2 wound healing cheap actos 45mg mastercard. Drivers with embolic or thrombotic cerebral infarctions will have residual intellectual or physical impairments diabetes medications list 2012 purchase actos 30 mg visa. Fatigue diabetes type 2 medscape purchase 15mg actos visa, prolonged work diabetes mellitus zinc order 30 mg actos amex, and stress may exaggerate the neurological residuals from a stroke. The neurological examination should include assessment of: · · · · · · · Cognitive abilities. Decision Maximum certification - 1 year Page 160 of 260 Recommend to certify if: the driver with a history of stroke has: · · · · Completed the appropriate waiting period. Normal physical examination, neurological examination including neuro-ophthalmological evaluation, and neuropsychological testing. No neurological residuals or, if present, residuals of a severity that does not interfere with ability to operate a commercial motor vehicle. Recommend not to certify if: the driver: · · · · · Has not completed the appropriate waiting period. Uses oral anticoagulant therapy because of the risks associated with excessive bleeding. Uses any other drug or combination of drugs that have potentially high rates of complications. Intracerebral and Subarachnoid Hemorrhages Intracerebral hemorrhage results from bleeding into the substance of the brain and subarachnoid hemorrhage reflects bleeding primarily into the spaces around the brain. Bleeding occurs as a result of a number of conditions including hypertension, hemorrhagic disorders, trauma, cerebral aneurysms, neoplasms, arteriovenous malformations, and degenerative or inflammatory vasculopathies. Subarachnoid and intracerebral hemorrhages can cause serious residual neurological deficits in: · · · · Cognitive abilities. The risk for seizures following intracerebral and subarachnoid hemorrhages is associated with the location of the hemorrhage: · Cerebellum and brainstem vascular hemorrhages are not associated with an increased risk for seizures. Page 161 of 260 · · Cortical and subcortical hemorrhages are associated with an increased risk for seizures. Decision Maximum certification - 1 year Recommend to certify if: the driver with a history of intracranial or subarachnoid hemorrhage has: · · · · Completed the appropriate waiting period. Clearance from a neurologist who understands the functions and demands of commercial driving. Recommend not to certify if: the driver: · · · · · Has not completed the appropriate waiting period Uses oral anticoagulant therapy because of the risks associated with excessive bleeding. Has residual intellectual or physical impairments that interfere with commercial driving. Does not have clearance from a neurologist who understands the functions and demands of commercial driving. Page 162 of 260 Transient Ischemic Attack Intracerebral hemorrhage results from bleeding into the substance of the brain and subarachnoid hemorrhage reflects bleeding primarily into the spaces around the brain. The risk for seizures following intracerebral and subarachnoid hemorrhages is associated with the location of the hemorrhage: · · · Cerebellum and brainstem vascular hemorrhages are not associated with an increased risk for seizures. Cortical and subcortical hemorrhages are associated with an increased risk for seizures. Appropriate evaluation by a neurologist is required to confirm the area of involvement. The recommendations for intracranial and subarachnoid hemorrhages parallel recommendations for strokes. No neurological residuals or, if present, residuals of a severity that do not interfere with the ability to operate a commercial motor vehicle. Page 163 of 260 Recommend not to certify if: the driver: · · · · · Has not completed the appropriate waiting period Uses oral anticoagulant therapy because of the risks associated with excessive bleeding. Uses any other drug or drug combination with a potentially high rate of complications. Disturbances of behavioral or emotional functioning may result in total or partial disability and/or psychological maladjustment.
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