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61 | LLY | 2017 | •Alimta in major European countries (vitamin regimen patent 2021) and Japan (patents covering use to treat cancer concomitantly with vitamins 2021). | [3.705741255544126e-05, -0.016598457470536232, 0.012461892329156399, -0.03071758709847927, -0.008449293673038483, 0.037242136895656586, -0.017812024801969528, -0.006367961876094341, -0.011887731961905956, 0.004603070672601461, 0.023579727858304977, 0.007535856682807207, 0.00935620628297329, -0.005190280266106129, -0.01... |
62 | LLY | 2017 | •Cymbalta in Japan (data package protection January 2018). | [-0.01694037765264511, -0.00588651467114687, 0.018724976107478142, -0.011013909243047237, -0.018285486847162247, 0.027781153097748756, -0.009762025438249111, -0.0016772238304838538, 0.017592955380678177, -0.013770715333521366, 0.012718601152300835, 0.04208458587527275, -0.0030697775073349476, -0.0056867459788918495, -0... |
63 | LLY | 2017 | •Forteo in Japan (data package protection July 2018; patent covering its formulation and related process August 2019). | [-0.01400800421833992, -0.002428258303552866, -0.013565574772655964, -0.016376705840229988, -0.006490102969110012, 0.011564431712031364, -0.020365379750728607, 0.00818154588341713, 0.005509951151907444, 0.0006006833864375949, 0.019766397774219513, 0.01916741579771042, -0.007643823511898518, -0.010209916159510612, 0.004... |
64 | LLY | 2017 | •Lartruvo in major European countries (compound patent and data package protection 2026, not including possible patent extension). | [-0.010725459083914757, -0.005279817618429661, 0.005876781884580851, -0.0335891917347908, -0.000832019024528563, 0.019009996205568314, -0.019169187173247337, -0.00762124452739954, -0.0239714328199625, 0.002513882936909795, 0.0062847076915204525, 0.014618992805480957, -0.009259579703211784, -0.002963264472782612, 0.0174... |
65 | LLY | 2017 | •Olumiant in major European countries (compound patent 2029, not including possible patent extension) and Japan (compound patent 2033). | [-0.0012835157103836536, 0.0006233635358512402, 0.010497033596038818, -0.02922164835035801, 0.0005138150881975889, 0.03011111542582512, -0.02088942378759384, 0.0030853429343551397, -0.03463694080710411, 0.001233646646142006, 0.02788744494318962, -0.001172332209534943, -0.004447341430932283, 0.006827977020293474, -0.013... |
66 | LLY | 2017 | •Taltz in major European countries (compound patent and data package protection 2026, not including possible patent extension). | [-0.009595982730388641, -0.014250164851546288, 0.02087845280766487, -0.04295967146754265, -0.007327722385525703, 0.029964566230773926, -0.03409580886363983, -0.005239223595708609, -0.010105851106345654, -0.0038501592352986336, -0.0018172228010371327, 0.016341932117938995, 0.007563046179711819, -0.0035788831301033497, 0... |
67 | LLY | 2017 | Baricitinib (Olumiant), has been submitted for regulatory review in the U.S. and is protected by a compound patent in the U.S. until 2030 (not including possible patent extension). Galcanezumab has been submitted for regulatory review in the U.S. and is protected by a compound patent (2033). Additional information abou... | [-0.010171317495405674, -0.006526373792439699, 0.020369190722703934, -0.032372940331697464, 0.013550691306591034, 0.026782698929309845, -0.019625596702098846, -0.0005099767004139721, -0.020687874406576157, 0.006084864493459463, 0.020077064633369446, 0.0002607976784929633, 0.0012689249124377966, -0.004352022428065538, -... |
68 | LLY | 2017 | Worldwide, we sell all of our major products under trademarks that we consider in the aggregate to be important to our operations. Trademark protection varies throughout the world, with protection continuing in some countries as long as the mark is used, and in other countries as long as it is registered. Registrations... | [-0.007368665654212236, -0.01828402280807495, 0.014327606186270714, -0.03482671082019806, 0.000516558822710067, 0.005159986671060324, -0.008860324509441853, 0.01009590458124876, 0.013777036219835281, -0.016312215477228165, -0.008290549740195274, 0.023277558386325836, -0.0051663885824382305, -0.002776853973045945, -0.00... |
69 | LLY | 2017 | Most of our major products are not subject to significant license agreements. The compound patent for Cialis is the subject of a license agreement with GlaxoSmithKline (Glaxo), which assigns to us exclusively all rights in the compound. The agreement calls for royalties of a single-digit percentage of net sales. The ag... | [0.004262770526111126, -0.0054725660011172295, 0.013183756731450558, -0.03455793112516403, -0.005817743018269539, 0.0226141307502985, -0.013197161257266998, 0.0032104826532304287, -0.024289747700095177, -0.029115526005625725, 0.03514774888753891, 0.033029768615961075, 0.0007975937915034592, 0.005697098560631275, 0.0068... |
70 | LLY | 2017 | In the U.S., the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, authorizes the FDA to approve generic versions of innovative human pharmaceuticals (other than biologics) without completion of safety and efficacy studies, i.e., a complete New Drug Application (NDA... | [-0.00919395312666893, -0.004667855333536863, -0.00028815484256483614, 0.006679454352706671, -0.024355201050639153, 0.008599923923611641, -0.016902834177017212, -0.0083704125136137, -0.03099752776324749, -0.0064735691994428635, 0.016997337341308594, -0.002710258588194847, 0.01216410007327795, 0.007769633084535599, -0.0... |
71 | LLY | 2017 | Absent a patent challenge, the FDA cannot approve an ANDA until after the innovator’s patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that one or more of the patents listed in the innovator’s NDA are invalid or not infringed. This al... | [-0.007607112638652325, -0.012579698115587234, -0.009972122497856617, 0.006215732078999281, -0.019998149946331978, -0.00339254317805171, -0.04468589276075363, -0.009109669364988804, -0.036896854639053345, 0.012707718648016453, 0.018259765580296516, 0.014715619385242462, -0.005491405725479126, 0.004753603134304285, 0.01... |
72 | LLY | 2017 | Generic manufacturers use Paragraph IV certifications extensively to challenge patents on innovative human pharmaceuticals. In addition, generic companies have shown willingness to launch “at risk,” i.e., after receiving ANDA approval but before final resolution of their patent challenge. We are currently in litigation... | [-0.0006639578496105969, -0.015482055954635143, -0.015784012153744698, -0.01942119561135769, -0.02613283321261406, 0.01929766871035099, -0.020395686849951744, 0.0021274101454764605, -0.02154860645532608, -0.0212054755538702, 0.02106822282075882, 0.015207551419734955, -0.0009667706908658147, -0.0014308548998087645, 0.00... |
73 | LLY | 2017 | Under the Biologics Price Competition and Innovation Act of 2009 (the BPCI Act), the FDA cannot approve a biosimilar application until data protection expires, 12 years after initial marketing approval of the innovator biologic. However, the Act does provide a mechanism for a competitor to challenge the validity of an ... | [-0.02140549011528492, -0.01785147376358509, 0.008186446502804756, -0.013748075813055038, -0.011191083118319511, 0.0035201043356209993, -0.023521622642874718, 0.003340368624776602, -0.03779194876551628, -0.01444667112082243, 0.016657758504152298, 0.003362411865964532, 0.0006697693606838584, -0.008857911452651024, 0.011... |
74 | LLY | 2017 | In addition, there is a procedure in U.S. patent law known as IPR, which allows any member of the public to file a petition with the USPTO seeking the review of any issued U.S. patent. IPRs are conducted before Administrative Patent Judges in the USPTO using a lower standard of proof than used in federal district court... | [-0.000929482514038682, -0.006610405165702105, 0.002209106693044305, -0.024912498891353607, -0.0003983496280852705, 0.015007040463387966, -0.005263966508209705, -0.013579409569501877, -0.006532595958560705, -0.010142269544303417, 0.013450855389237404, 0.0025406419299542904, 0.009966352954506874, 0.0014910624595358968, ... |
75 | LLY | 2017 | Outside the U.S., the legal doctrines and processes by which pharmaceutical patents can be challenged vary widely. In recent years, we have experienced an increase in patent challenges from generic manufacturers in many countries outside the U.S., and we expect this trend to continue. For more information on administra... | [0.0077770003117620945, -0.01917182467877865, 0.0031358872074633837, -0.029893258586525917, -0.0013533829478546977, 0.025377580896019936, -0.0018782314145937562, 0.008945531211793423, -0.026869602501392365, -0.019145417958498, 0.00875407736748457, 0.003944616299122572, -0.0059218755923211575, -0.007902435958385468, 0.0... |
76 | LLY | 2017 | Our operations are regulated extensively by numerous national, state, and local agencies. The lengthy process of laboratory and clinical testing, data analysis, manufacturing development, and regulatory review necessary for governmental approvals is extremely costly and can significantly delay product introductions. Pr... | [0.014626665972173214, -0.0027763578109443188, -0.01572333462536335, -0.025144124403595924, -0.008885666728019714, 0.019251175224781036, 0.003298266790807247, 0.02490629255771637, -0.025923684239387512, -0.004446136299520731, -0.011263986118137836, -0.013318589888513088, -0.020929213613271713, -0.007590803317725658, -0... |
77 | LLY | 2017 | Of particular importance is the FDA in the U.S. Pursuant to the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over all of our human pharmaceutical products and certain animal health products in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality con... | [0.016155973076820374, -0.0036062439903616905, -0.01981467194855213, -0.020129399374127388, -0.01838528737425804, 0.01096298173069954, -0.007599339820444584, 0.01932946778833866, -0.009907335974276066, 0.004897935315966606, 0.016051065176725388, -0.01573633775115013, -0.01255628652870655, 0.00457337312400341, -0.025020... |
78 | LLY | 2017 | The FDA extensively regulates all aspects of manufacturing quality for human pharmaceuticals under its current Good Manufacturing Practices (cGMP) regulations. Outside the U.S., our products and operations are subject to similar regulatory requirements, notably by the European Medicines Agency in the EU and the Ministr... | [0.02282380871474743, -0.006420019082725048, -0.012833456508815289, -0.024561261758208275, -0.010674803517758846, 0.022573720663785934, -0.0014635076513513923, 0.0246665608137846, -0.017664100974798203, -0.011411904357373714, -0.0005429539014585316, 0.00392901198938489, -0.01328098215162754, -0.011714641936123371, -0.0... |
79 | LLY | 2017 | The marketing, promotional, and pricing practices of human pharmaceutical manufacturers, as well as the manner in which manufacturers interact with purchasers and prescribers, are subject to various other U.S. federal and state laws, including the federal anti-kickback statute and the False Claims Act and state laws go... | [-0.001395628903992474, -0.0036746086552739143, -0.0034020505845546722, -0.026979969814419746, -0.015683583915233612, 0.007230999413877726, 0.006764695048332214, 0.010764403268694878, -0.0338628813624382, -0.014632758684456348, 0.011808661743998528, -0.0008394297328777611, -0.0035235523246228695, 0.010436019860208035, ... |
80 | LLY | 2017 | The U.S. Foreign Corrupt Practices Act of 1977 (FCPA) prohibits certain individuals and entities, including U.S. publicly traded companies, from promising, offering, or giving anything of value to foreign officials with the corrupt intent of influencing the foreign official for the purpose of helping the company obtain... | [0.0006307286093942821, -0.013591237366199493, 0.016217563301324844, -0.04341316968202591, -0.0035652376245707273, 0.0014411964220926166, -0.019828760996460915, 0.011838164180517197, 0.00199436629191041, -0.017543857917189598, 0.016230694949626923, 0.008903245441615582, 0.011431084014475346, 0.0062046954408288, -0.0133... |
81 | LLY | 2017 | In addition to the U.S. application and enforcement of the FCPA, the various jurisdictions in which we operate and supply our products have laws and regulations aimed at preventing and penalizing corrupt and anticompetitive behavior. In recent years, several jurisdictions, including China, Brazil, and the United Kingdo... | [-0.003882862161844969, -0.007177906576544046, 0.007648161146789789, -0.04247962310910225, -0.007282407488673925, 0.015440010465681553, -0.011188129894435406, 0.02012948878109455, -0.0046470253728330135, -0.03315291553735733, 0.01278176810592413, 0.0010735836112871766, 0.020847933366894722, -0.0001561390672577545, -0.0... |
82 | LLY | 2017 | It is possible that we could become subject to additional administrative and legal proceedings and actions, which could include claims for civil penalties (including treble damages under the False Claims Act), criminal sanctions, and administrative remedies, including exclusion from U.S. federal and other health care p... | [-0.004983203019946814, -0.012098783627152443, -0.0018863342702388763, -0.04658425226807594, -0.021743692457675934, 0.021113820374011993, -0.019670365378260612, 0.004107287619262934, -0.00010215934889856726, -0.0033691569697111845, 0.015589321963489056, 0.026192160323262215, 0.01208566129207611, 0.005429361946880817, 0... |
83 | LLY | 2017 | In the U.S., we are required to provide rebates to the federal government and respective state governments on their purchases of our human pharmaceuticals under state Medicaid and Medicaid Managed Care programs (minimum of 23.1 percent plus adjustments for price increases over time) and rebates to private payers who co... | [-0.002072868635877967, 0.004640995059162378, -0.004627875983715057, -0.023496882990002632, -0.006556430831551552, 0.015074214898049831, -0.006454755086451769, -0.005772545468062162, -0.024533318355679512, 0.0066285873763263226, 0.021515849977731705, 0.03460903465747833, -0.013880347833037376, 0.0033815307542681694, -0... |
84 | LLY | 2017 | Rebates are also negotiated in the private sector. We give rebates to private payers who provide prescription drug benefits to seniors covered by Medicare and to private payers who provide prescription drug benefits to their customers. These rebates are affected by the introduction of competitive products and generics ... | [0.00868474505841732, -0.013528410345315933, 0.0027164241764694452, -0.027968263253569603, -0.004798093810677528, 0.024296453222632408, 0.0043944548815488815, 0.008958177641034126, -0.02592402882874012, -0.006666550878435373, 0.008697764948010445, 0.02716098539531231, -0.0013289157068356872, -0.007942570373415947, -0.0... |
85 | LLY | 2017 | In most international markets, we operate in an environment of government-mandated cost-containment programs, which may include price controls, international reference pricing (to other countries’ prices), discounts and rebates, therapeutic reference pricing (to other, often generic, pharmaceutical choices), restrictio... | [0.002461003139615059, -0.02711922489106655, -0.002891387790441513, -0.027571210637688637, 0.005835950840264559, 0.02097751758992672, 0.002758450573310256, 0.013971718028187752, -0.016617171466350555, -0.003619220107793808, -0.003296846756711602, 0.016989396885037422, 0.007072268519550562, -0.005347406025975943, -0.009... |
86 | LLY | 2017 | Globally, public and private payers are increasingly restricting access to human pharmaceuticals based on assessments of comparative effectiveness and value, including through the establishment of formal health technology assessment processes. In addition, third party organizations, including professional associations,... | [-0.0003559680772013962, -0.004093219991773367, 0.014985347166657448, -0.04947543144226074, -0.004245187621563673, 0.01435104664415121, 0.0034390976652503014, 0.01045274268835783, -0.024922721087932587, -0.007935362868010998, -0.007710714358836412, -0.001375143532641232, 0.018407925963401794, -0.004066790454089642, -0.... |
87 | LLY | 2017 | We cannot predict the extent to which our business may be affected by these or other potential future legislative, regulatory, or payer developments. However, in general we expect that state, federal, and international legislative and regulatory developments could have further negative effects on pricing and reimbursem... | [-0.0049309139139950275, -0.014687829650938511, 0.004498147871345282, -0.03375577926635742, 0.00031064104405231774, 0.015448449179530144, -0.01682543382048607, 0.02218911424279213, -0.02372346632182598, 0.005586620885878801, -0.004934192635118961, 0.0053079454228281975, 0.026031553745269775, 0.004445691127330065, 8.175... |
88 | LLY | 2017 | Our commitment to research and development dates back more than 140 years. We invest heavily in research and development because we believe it is critical to our long-term competitiveness. At the end of 2017, we employed approximately 9,000 people in human pharmaceutical and animal health research and development activ... | [0.0030253378208726645, -0.011017843149602413, -0.002729984000325203, -0.03039044886827469, 0.0056166197173297405, 0.0193726047873497, 0.004768088925629854, 0.02220539189875126, -0.009875589981675148, 0.018432695418596268, -0.0006776006193831563, 0.030051035806536674, -0.006556530483067036, -0.009966970421373844, -0.01... |
89 | LLY | 2017 | Our internal human pharmaceutical research focuses primarily on the areas of cancer, diabetes, neurodegeneration, immunology, and pain. We have a strong biotechnology research program, with more than half of our clinical-stage pipeline currently consisting of biologics. In addition to discovering and developing NMEs, w... | [-0.014784983359277248, -0.009462119080126286, 0.006175064016133547, -0.019560005515813828, -0.0009604152292013168, 0.030246315523982048, -0.012546269223093987, 0.021764902397990227, -0.014392700977623463, 0.011213862337172031, -0.004727677907794714, 0.006841267459094524, 0.01205929834395647, -0.012072824873030186, -0.... |
90 | LLY | 2017 | To supplement our internal efforts, we collaborate with others, including academic institutions and research-based pharmaceutical and biotechnology companies. We use the services of physicians, hospitals, medical schools, and other research organizations worldwide to conduct clinical trials to establish the safety and ... | [0.0035112302284687757, -0.006401839666068554, 0.0005097354878671467, -0.021263012662529945, -0.009100191295146942, 0.049298886209726334, 0.009019240736961365, 0.018834495916962624, 0.002150248968973756, 0.004168953280895948, -0.007710540201514959, 0.010179531760513783, 0.01520521193742752, -0.004813184961676598, -0.01... |
91 | LLY | 2017 | Our Elanco animal health innovation strategy is focused on identifying and developing promising technologies and potential products from internal and external sources to meet unmet veterinary, food producer, and pet owner needs. Our animal health scientists also leverage discoveries from our human health laboratories t... | [-0.008930890820920467, -0.009205583482980728, -0.004103653598576784, -0.022189879789948463, 0.005219177342951298, 0.027603352442383766, -0.029452508315443993, -0.0067902905866503716, -0.0337672084569931, 0.004820536822080612, 0.005875762086361647, 0.006127006374299526, -0.014632456935942173, -0.011403132230043411, 0.0... |
92 | LLY | 2017 | Human pharmaceutical development is time-consuming, expensive, and risky. On average, only one out of many thousands of molecules discovered by researchers ultimately becomes an approved medicine. The process from discovery to regulatory approval can take over a decade. Drug candidates can fail at any stage of the proc... | [0.013294526375830173, -0.0001773906114976853, 0.0038106588181108236, -0.018112147226929665, -0.005271740257740021, 0.010780412703752518, 0.008727001026272774, 0.0157823134213686, -0.03801444545388222, 0.010411852039396763, 0.007522595580667257, 0.00744361849501729, -0.00781876128166914, -0.0001249446941073984, -0.0193... |
93 | LLY | 2017 | The earliest phase of new drug research and development, the discovery phase, can take many years. Scientists identify, design, and synthesize promising molecules, screening tens of thousands of molecules for their effect on biological targets that appear to play an important role in one or more diseases. Targets can b... | [-0.014818422496318817, -0.017383649945259094, 0.004983964376151562, -0.017943574115633965, -0.0028956474270671606, 0.03953315690159798, -0.0017285989597439766, 0.0018816011724993587, -0.044194839894771576, -0.0016073365695774555, 0.0064326017163693905, 0.02102966047823429, -0.0023568845354020596, 0.018894139677286148,... |
94 | LLY | 2017 | The early development phase involves refining candidate molecules, understanding how to manufacture them efficiently, and completing initial testing for safety and efficacy. Safety testing is done first in laboratory tests and animals as necessary, to identify toxicity and other potential safety issues that would precl... | [0.005427299067378044, -0.017635468393564224, -0.0044251359067857265, -0.012299275025725365, -0.022112665697932243, 0.03927959129214287, 0.009351353161036968, 0.020576883107423782, -0.032563794404268265, -0.006078054662793875, 0.015357824973762035, 0.0024289442226290703, 0.003107356606051326, 0.005127951502799988, -0.0... |
95 | LLY | 2017 | Product phase (Phase III) molecules have met initial safety requirements and, typically, shown initial evidence of efficacy. As a result, these molecules generally have a higher likelihood of success. The molecules are tested in much larger patient populations to demonstrate efficacy to a predetermined level of statist... | [0.0024960823357105255, -0.016796553507447243, -0.002509082667529583, -0.013494445011019707, -0.015288504771888256, 0.039859313517808914, -0.0046216524206101894, 0.0193056371062994, -0.03608918935060501, -0.007923761382699013, 0.008970296010375023, 0.006428712047636509, -0.001958189532160759, -0.0011879141675308347, -0... |
96 | LLY | 2017 | Once a molecule is submitted to regulatory agencies, the time to final marketing approval can vary from several months to several years, depending on variables such as the disease state, the strength and complexity of the data presented, the novelty of the target or compound, and the time required for the agency(ies) t... | [0.02438191883265972, -0.0030917918775230646, -0.008797330781817436, -0.017490241676568985, -0.027279555797576904, 0.0021210182458162308, -0.016393838450312614, 0.008797330781817436, -0.053018927574157715, 0.010520249605178833, 0.011708020232617855, -0.010618142783641815, -0.010905296541750431, 0.010376673191785812, -0... |
97 | LLY | 2017 | We believe our investments in research, both internally and in collaboration with others, have been rewarded by the large number of new molecules and new indications for existing molecules that we have in all stages of development. We currently have approximately 40 drug candidates across all stages of human testing an... | [-0.002403167774900794, -0.010700525715947151, -0.006810624152421951, -0.03235870599746704, -0.004717329517006874, 0.021823005750775337, -0.010529105551540852, 0.027532590553164482, -0.014583833515644073, 0.005739253014326096, 0.012843267992138863, 0.005116209387779236, -0.0031778516713529825, -0.004173402674496174, -0... |
98 | LLY | 2017 | Most of the principal materials we use in our manufacturing operations are available from more than one source. However, we obtain certain raw materials primarily from only one source. In the event one of these suppliers was unable to provide the materials or product, we generally seek to maintain sufficient inventory ... | [0.003141342429444194, -0.008250794373452663, -0.023338530212640762, -0.004059019032865763, -0.02904704585671425, 0.013003464788198471, -0.004155267495661974, 0.002666739048436284, 0.004175181034952402, -0.017523812130093575, -0.0010935787577182055, 0.01990014687180519, 0.005290332715958357, 0.0059740268625319, -0.0116... |
99 | LLY | 2017 | The majority of our revenue comes from products produced in our own facilities. Our principal active ingredient manufacturing occurs at sites we own in the U.S., Ireland, and Puerto Rico. Finishing operations, including formulation, filling, assembling, delivery device manufacturing, and packaging, take place at a numb... | [0.011776963248848915, 0.003288924228399992, -0.02462702989578247, -0.016531215980648994, -0.011654711328446865, 0.026379311457276344, -0.011851673014461994, 0.011702253483235836, -0.0038815077859908342, -0.016368214040994644, 0.013841667212545872, 0.0212447177618742, -0.029693705961108208, 0.0032702467869967222, -0.00... |
100 | LLY | 2017 | We manage our supply chain (including our own facilities, contracted arrangements, and inventory) in a way that should allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. To maintain a stable s... | [-0.005268843844532967, -0.006533896084874868, -0.01600191928446293, 0.0008076299563981593, -0.018320078030228615, 0.024943388998508453, -0.025446759536862373, 0.016134385019540787, 0.012127282097935677, -0.006361689884215593, -0.0025549421552568674, 0.015803219750523567, -0.007815507240593433, 0.008908352814614773, 0.... |
101 | LLY | 2017 | However, human pharmaceutical and animal health production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity can be a very lengthy process requiring significant capital expenditures, process modifications, and regulatory approvals. Accordingly, i... | [0.006095114164054394, -0.02658824250102043, -0.008411257527768612, -0.0026699986774474382, -0.02950035221874714, 0.02416374161839485, -0.01116760354489088, 0.028037525713443756, -0.03394301235675812, 0.008418030105531216, 0.0035013044252991676, 0.02647988498210907, -0.006714784074574709, 0.0030441710259765387, 0.00195... |
102 | LLY | 2017 | Our success depends in great measure upon customer confidence in the quality of our products and in the integrity of the data that support their safety and effectiveness. Product quality arises from a total commitment to quality in all parts of our operations, including research and development, purchasing, facilities ... | [0.003387091215699911, 0.010414729826152325, 0.0007434978033415973, -0.03536531329154968, -0.022159278392791748, 0.03325866907835007, 0.019670803099870682, 0.010368646122515202, -0.006471352186053991, -0.01334428321570158, -0.007030929904431105, 0.021816948428750038, -0.023252101615071297, -0.002603682456538081, -0.026... |
103 | LLY | 2017 | Quality of production processes involves strict control of ingredients, equipment, facilities, manufacturing methods, packaging materials, and labeling. We perform tests at various stages of production processes and on the final product to assure that the product meets all regulatory requirements and Lilly internal sta... | [0.001809766166843474, 0.011350056156516075, -0.010353854857385159, -0.012844358570873737, -0.018516065552830696, 0.007624262478202581, -0.0006790774059481919, 0.009683079086244106, -0.02938130497932434, -0.004130915738642216, -0.006511837709695101, 0.018356673419475555, -0.009975298307836056, 0.004951121751219034, -0.... |
104 | LLY | 2017 | The following table sets forth certain information regarding our executive officers. Except as otherwise noted, all executive officers have been employed by the company in management or executive positions during the last five years. | [-0.03697553649544716, -0.01564057730138302, -0.003176201367750764, -0.04932602494955063, -0.043505098670721054, 0.0035842987708747387, -0.009047744795680046, 0.018601655960083008, -0.0065611968748271465, 0.009825977496802807, 0.012685824185609818, 0.017399508506059647, 0.0017589321359992027, 0.008857931941747665, 0.00... |
105 | LLY | 2017 | The term of office for each executive officer expires on the date of the annual meeting of the Board of Directors, to be held on May 7, 2018, or on the date his or her successor is chosen and qualified. Dr. Lundberg will retire from the company effective May 31, 2018; he will be succeeded by Dr. Daniel Skovronsky, M.D.... | [-0.030572226271033287, -0.018921304494142532, -0.015743780881166458, -0.02237343043088913, -0.020346613600850105, 0.017417538911104202, -0.02991841360926628, -0.00979409646242857, -0.010814042761921883, -0.0028048513922840357, 0.02109195850789547, 0.006587150972336531, -0.00631581898778677, 0.017927510663866997, 0.003... |
106 | LLY | 2017 | officer of the company, as that term is defined for purposes of this disclosure requirement. There is no understanding between any executive officer and any other person pursuant to which the executive officer was selected. | [-0.04117986187338829, -0.015725968405604362, -0.0005268766544759274, -0.015272335149347782, -0.037424780428409576, 0.0021232578437775373, -0.005081327632069588, 0.0032415909226983786, -0.012966363690793514, -0.006013797130435705, 0.006020097527652979, -0.002042926847934723, -0.013785424642264843, -0.002272893907502293... |
107 | LLY | 2017 | At the end of 2017, we employed approximately 40,655 people, including approximately 22,235 employees outside the U.S. These numbers decreased to approximately 38,350 total employees, including approximately 21,950 employees outside the U.S., as of January 31, 2018, following a voluntary early retirement program in the... | [-0.006492758635431528, -0.009533018805086613, -0.009971022605895996, -0.0210628192871809, -0.023858312517404556, 0.006975851021707058, -0.02550726756453514, 0.023381661623716354, 0.003449278185144067, 0.004254431929439306, -0.004943643230944872, 0.01741708256304264, -0.026950102299451828, -0.006615142337977886, -0.009... |
108 | LLY | 2017 | You can find financial information relating to our business segments and classes of products in Item 8, "Financial Statements and Supplementary Data - Note 18, Segment Information." That information is incorporated here by reference. | [-0.00974944792687893, -0.011357273906469345, -0.008365820161998272, -0.04312305152416229, -0.005819561891257763, 0.002216365886852145, -0.012465456500649452, 0.0014204599428921938, 0.01519427727907896, -0.018563665449619293, 0.018051210790872574, 0.0481451041996479, -0.018140891566872597, 0.0027288205455988646, -0.005... |
109 | LLY | 2017 | The relative contribution of any particular product to our consolidated revenue changes from year to year. This is due to several factors, including the introduction of new products by us and by other manufacturers and the introduction of generic pharmaceuticals upon patent expirations. Our product revenues are general... | [0.009022529236972332, -0.02715276926755905, 0.01028712559491396, -0.01072612963616848, 0.003666016971692443, -0.002614371245726943, 0.00020506679720710963, 0.0038527576252818108, -0.028882578015327454, -0.022395793348550797, 0.013058751821517944, 0.015306194312870502, 0.0015668208943679929, 0.004278657957911491, -0.01... |
110 | LLY | 2017 | You can find financial information relating to foreign and domestic operations in Item 8, “Financial Statements and Supplementary Data - Note 18, Segment Information.” That information is incorporated here by reference. To date, our overall operations abroad have not been significantly deterred by local restrictions on... | [-0.013623671606183052, -0.020377397537231445, 0.000382560450816527, -0.03902439400553703, 0.002046779030933976, 0.013972334563732147, -0.015263677574694157, 0.005313877481967211, 0.014475958421826363, -0.021862441673874855, -0.003757809055969119, 0.04300172999501228, -0.025349069386720657, 0.003951510414481163, -0.005... |
111 | LLY | 2017 | Our company website is https://www.lilly.com. None of the information accessible on or through our website is incorporated into this Form 10-K. We make available through the website, free of charge, our company filings with the Securities and Exchange Commission (SEC) as soon as reasonably practicable after we electron... | [-0.017789699137210846, -0.013963818550109863, 0.004621328320354223, -0.03547634184360504, -0.016334060579538345, 0.0044248816557228565, -0.03197250887751579, -0.0041672466322779655, 0.0021770161110907793, 0.0032977284863591194, 0.006949705071747303, 0.029241574928164482, -0.001702001434750855, 0.002983735641464591, 0.... |
112 | LLY | 2017 | In addition, the Corporate Governance portion of our website includes our corporate governance guidelines, board and committee information (including committee charters), and our articles of incorporation and by-laws. The link to our corporate governance information is https://www.lilly.com/about/corporate-governance/P... | [-0.00431894650682807, -0.005459251813590527, -0.014562312513589859, -0.05132342875003815, -0.024498797953128815, -0.0022935320157557726, -0.023736439645290375, 0.018516231328248978, -0.01608702726662159, -0.013153890147805214, 0.0009779813699424267, -0.008644353598356247, 0.0037051846738904715, 0.007720480673015118, 0... |
113 | LLY | 2017 | We will provide paper copies of our SEC filings free of charge upon request to the company’s secretary at the address listed on the front of this Form 10-K. | [-0.024142781272530556, -0.011466547846794128, -0.0035908569116145372, -0.01730487309396267, -0.0014237683499231935, 0.02207995019853115, -0.04594259336590767, 0.010613401420414448, 0.010154994204640388, 0.01084260456264019, 0.030254878103733063, 0.0436505563557148, 0.013064607046544552, 0.0010385789209976792, 0.017343... |
114 | LLY | 2017 | In addition to the other information contained in this Form 10-K, the following risk factors should be considered carefully in evaluating our company. It is possible that our business, financial condition, liquidity, or results of operations could be materially adversely affected by any of these risks. Certain of these... | [-0.004984521307051182, -0.02775217778980732, 0.004533708095550537, -0.038980938494205475, -0.016958242282271385, 0.01670246198773384, -0.04363614320755005, 0.017060555517673492, 0.009048232808709145, -0.007814092561602592, -0.004127657040953636, 0.02560362219810486, -0.013581940904259682, -0.0007073927554301918, 0.015... |
115 | LLY | 2017 | •Pharmaceutical research and development is very costly and highly uncertain; we may not succeed in developing or acquiring commercially successful products sufficient in number or value to replace revenues of products that have lost or will soon lose intellectual property protection. | [0.00360125838778913, -0.018888631835579872, 0.014588037505745888, -0.01993436925113201, 0.0028218571096658707, 0.01630043238401413, 0.004944377113133669, 0.01208480354398489, -0.002794079715386033, 0.01538541167974472, 0.01492790225893259, 0.026797020807862282, 0.007875709794461727, -0.003702564164996147, -0.027659755... |
116 | LLY | 2017 | There are many difficulties and uncertainties inherent in human pharmaceutical research and development and the introduction of new products. There is a high rate of failure inherent in new drug discovery and development. To bring a drug from the discovery phase to market can take over a decade and often costs in exces... | [0.012534328736364841, -0.015640122815966606, 0.0005663986667059362, -0.021485552191734314, -0.006057932041585445, 0.0032316597644239664, 0.009343534708023071, 0.007689290679991245, -0.04493265971541405, 0.008558913134038448, 0.007159671280533075, 0.012050478719174862, -0.0071792867965996265, 0.006561397109180689, -0.0... |
117 | LLY | 2017 | We cannot state with certainty when or whether our products now under development will be approved or launched; whether, if initially granted, such approval will be maintained; whether we will be able to develop, license, or otherwise acquire additional product candidates or products; or whether our products, once laun... | [-0.002897161990404129, -0.008949648588895798, 0.0017700191820040345, -0.01804778352379799, -0.010117287747561932, 0.008193721063435078, -0.012574054300785065, 0.012256834656000137, -0.004376959055662155, 0.005963058210909367, 0.01714337058365345, 0.015523524023592472, -0.010292771272361279, -0.004768421407788992, -0.0... |
118 | LLY | 2017 | flows, financial position, and prospects. See Item 7, “Management’s Discussion and Analysis - Executive Overview - Late-Stage Pipeline,” for more details. | [-0.015744229778647423, -0.022690212354063988, 0.0016604207921773195, -0.03265273571014404, -0.006049620918929577, 0.005785011686384678, -0.024939388036727905, 0.005765166133642197, -0.010366053320467472, -0.0076207360252738, 0.022796055302023888, 0.016617437824606895, 0.002062295563519001, 0.01451379805803299, 0.01200... |
119 | LLY | 2017 | •We depend on products with intellectual property protection for most of our revenues, cash flows, and earnings; we have lost or will lose effective intellectual property protection for many of those products in the next several years, which has resulted and is likely to continue to result in rapid and severe declines ... | [-0.01778014749288559, -0.03452610224485397, 0.02325606159865856, -0.02264615334570408, 0.007272491697221994, 0.011893208138644695, -0.011893208138644695, 0.008266907185316086, 0.005359899252653122, -0.015618951991200447, 0.02726024203002453, 0.03166218847036362, 0.010487767867743969, -0.0011800396023318172, -0.0213998... |
120 | LLY | 2017 | A number of our top-selling human pharmaceutical products have recently lost, or will lose in the next several years, significant patent protection and/or data protection in the U.S. as well as key countries outside the U.S., as illustrated in the tables below: | [-0.0086513701826334, -0.022999005392193794, 0.02848132513463497, -0.021126993000507355, 0.0015260240761563182, 0.02342689409852028, -0.011004756204783916, 0.011165214702486992, -0.013184313662350178, -0.0025539593771100044, 0.014227291569113731, 0.02377455309033394, -0.008684799075126648, 0.004349085036665201, -0.0049... |
121 | LLY | 2017 | Certain other significant products no longer have effective exclusivity through patent protection or data protection. For non-biologic products, loss of exclusivity (whether by expiration or as a consequence of litigation) typically results in the entry of one or more generic competitors, leading to a rapid and severe ... | [-0.009607423096895218, -0.020022759214043617, 0.018366537988185883, -0.01676417887210846, -0.00814644806087017, 0.014582815580070019, 0.004611832555383444, -0.0013860744656994939, -0.020426714792847633, -0.03759485110640526, 0.013741240836679935, 0.025880122557282448, -0.01625250093638897, -0.009769005700945854, -0.00... |
122 | LLY | 2017 | •Our long-term success depends on intellectual property protection; if our intellectual property rights are invalidated, circumvented, or weakened, our business will be adversely affected. | [-0.007577121257781982, -0.028982967138290405, 0.014631683006882668, -0.039561621844768524, -0.019589630886912346, 0.019831793382763863, -0.0027322883252054453, 0.005423154216259718, 0.02131025493144989, 0.002792828716337681, 0.013369890861213207, 0.01855725608766079, 0.016403289511799812, -0.010094331577420235, -0.016... |
123 | LLY | 2017 | Our long-term success depends on our ability to continually discover, develop, and commercialize innovative new pharmaceutical products. Without strong intellectual property protection, we would be unable to generate the returns necessary to support the enormous investments in research and development and capital as we... | [0.001980113098397851, -0.007216412108391523, 0.016127735376358032, -0.04208596050739288, -0.023454969748854637, 0.02714466117322445, 0.005228150635957718, 0.017431514337658882, 0.0026678561698645353, 0.006258135195821524, 0.02361142262816429, 0.018800482153892517, 0.013187716715037823, 0.0031192891765385866, -0.029100... |
124 | LLY | 2017 | Intellectual property protection varies throughout the world and is subject to change over time. In the U.S., in addition to the process for challenging patents which applies to our biologic products, the Hatch-Waxman Act provides generic companies powerful incentives to seek to invalidate our other human pharmaceutica... | [-0.01406229566782713, -0.016559340059757233, 0.012478644959628582, -0.018425550311803818, -0.008305954746901989, 0.01987120695412159, 0.0041529773734509945, -0.0035188596230000257, -0.008424235507845879, -0.03388093411922455, -0.004340255632996559, 0.00048215934657491744, -0.0022982654627412558, -0.008010251447558403,... |
125 | LLY | 2017 | •Our human pharmaceutical business is subject to increasing government price controls and other public and private restrictions on pricing, reimbursement, and access for our drugs, which could have a material adverse effect on our business. | [-0.008426551707088947, -0.027138736099004745, -0.01095004566013813, -0.018859121948480606, -0.010592284612357616, 0.013390487059950829, 0.002116220770403743, 0.01664866879582405, -0.008036848157644272, 0.010886159725487232, -0.01304550375789404, 0.013288269750773907, 0.016929766163229942, -0.008912084624171257, -0.000... |
126 | LLY | 2017 | Public and private payers are taking increasingly aggressive steps to control their expenditures for human pharmaceuticals by placing restrictions on pricing and reimbursement for, and patient access to, our medications. These pressures could negatively affect our future revenues and net income. | [0.0022347618360072374, -0.021129874512553215, 0.018788058310747147, -0.03856636956334114, -0.005898031871765852, 0.013642752543091774, -0.0038606515154242516, 0.013421952724456787, -0.020286820828914642, 1.8543734768172726e-05, -0.009260211139917374, 0.011193881742656231, 0.0342574268579483, 0.001133271842263639, -0.0... |
127 | LLY | 2017 | We expect pricing, reimbursement, and access pressures from both governments and private payers inside and outside the U.S. to become more severe. For more details, see Item 1, “Business - Regulations and Private Payer Actions Affecting Human Pharmaceutical Pricing, Reimbursement, and Access,” and Item 7, “Management’s... | [0.006694714073091745, -0.019238142296671867, 0.011377682909369469, -0.04047470912337303, 0.0009634059970267117, 0.016560258343815804, -0.008559907786548138, 0.014455253258347511, -0.017905861139297485, -0.013496010564267635, -0.008180207572877407, 0.002129984786733985, 0.03309386968612671, -0.00420001707971096, 0.0063... |
128 | LLY | 2017 | •We face intense competition from multinational pharmaceutical companies, biotechnology companies, and lower-cost generic and biosimilar manufacturers, and such competition could have a material adverse effect on our business. | [-0.027448713779449463, -0.010793501511216164, 0.0006810071063227952, -0.013685877434909344, -0.008311573415994644, 0.03740207850933075, -0.012961179949343204, 0.017225991934537888, -0.004739392548799515, 0.0013291463255882263, -0.0024450519122183323, 0.04325096681714058, 0.008292333222925663, -0.029911402612924576, 0.... |
129 | LLY | 2017 | We compete with a large number of multinational pharmaceutical companies, biotechnology companies, and generic pharmaceutical companies. To compete successfully, we must continue to deliver to the market innovative, cost-effective products that meet important medical needs. Our product revenues can be adversely affecte... | [-0.01947683095932007, -0.022561335936188698, 0.004010530188679695, -0.002384093590080738, 0.006778503302484751, 0.030925868079066277, -0.0009630660060793161, 0.012378429062664509, -0.019490301609039307, -0.017200494185090065, -0.002601288491860032, 0.025362983345985413, 0.003997060935944319, -0.02396216057240963, -0.0... |
130 | LLY | 2017 | •Changes in foreign currency rates or devaluation of a foreign currency can materially affect our revenue, cost of sales, and operating expenses. | [-0.011819066479802132, -0.024330411106348038, 0.009459028951823711, -0.02073056809604168, -0.0016661862609907985, 0.007092698477208614, -0.014625937677919865, -0.008030420169234276, 0.018704082816839218, -0.005704996641725302, -0.00884227268397808, 0.056036725640296936, 0.01903134025633335, -0.0005471353069879115, 0.0... |
131 | LLY | 2017 | As a global company with substantial operations outside the U.S., we face foreign currency risk exposure from fluctuating currency exchange rates. While we manage a portion of these exposures through hedging and other risk management techniques, significant fluctuations in currency rates can have a material impact, eit... | [-0.006732146721333265, -0.024525171145796776, 0.000320616876706481, -0.011939546093344688, -0.005798561964184046, 0.013218783773481846, -0.019485753029584885, 0.0009077414870262146, 0.020764989778399467, -0.015441296622157097, -0.019123949110507965, 0.02760051004588604, 0.011758644133806229, 0.005772719159722328, 0.00... |
132 | LLY | 2017 | •Unanticipated changes in our tax rates or exposure to additional tax liabilities could increase our income taxes and decrease our net income. | [-0.009451829828321934, -0.04356224089860916, 0.00842595286667347, -0.03285308554768562, -0.002514649648219347, 0.0016232626512646675, -0.014875216409564018, -0.013936914503574371, 0.0020611369982361794, 0.007281224709004164, 0.03455454111099243, 0.014650024473667145, 0.020705200731754303, 0.018578382208943367, 0.00844... |
133 | LLY | 2017 | We are subject to income taxes in the U.S. and numerous foreign jurisdictions. Changes in the relevant tax laws, regulations, administrative practices, principles, and interpretations could adversely affect our future effective tax rates. The U.S. recently enacted tax reform legislation significantly revising the U.S. ... | [-0.02102666161954403, -0.032747477293014526, 0.0030929928179830313, -0.0577569417655468, -0.003685671603307128, 2.9905582778155804e-05, -0.01608293130993843, -0.0005061476840637624, 0.0045391288585960865, -0.011891506612300873, 0.0114236855879426, 0.005654945503920317, 0.017764557152986526, 0.012169670313596725, -0.00... |
134 | LLY | 2017 | •Failure, inadequacy, or breach of our information technology systems, infrastructure, and business information could result in material harm to our business and reputation. | [-0.017785394564270973, -0.021558834239840508, 0.004813389386981726, -0.0359056331217289, -0.012582425959408283, 0.01482330821454525, -0.01777251623570919, 0.0003185449750162661, 0.03920256346464157, -0.008557852357625961, -0.002290787175297737, 0.030161762610077858, 0.0091438302770257, 0.004842366557568312, 0.01563466... |
135 | LLY | 2017 | A great deal of confidential information owned by both us and our business partners is stored in our information systems, networks, and facilities or those of third parties. This includes valuable trade secrets and intellectual property, clinical trial information, corporate strategic plans, marketing plans, customer i... | [0.008241919800639153, -0.0005139003042131662, 0.022130237892270088, -0.05833744257688522, 0.0016449688700959086, 0.03000137023627758, -0.002101136604323983, 0.003698130836710334, 0.015807313844561577, -0.027815667912364006, 0.008866406977176666, 0.024146810173988342, -0.003730656113475561, -0.0024637943133711815, -0.0... |
136 | LLY | 2017 | IT systems are vulnerable to system inadequacies, operating failures, service interruptions or failures, security breaches, malicious intrusions, or cyber-attacks from a variety of sources. Cyber-attacks are growing in their frequency, sophistication, and intensity, and are becoming increasingly difficult to detect, mi... | [-0.006312076933681965, -0.011797077022492886, 0.004411080852150917, -0.030415941029787064, -0.0259022768586874, 0.03267277404665947, -0.0077642714604735374, -0.026184381917119026, 0.0063024600967764854, -0.03087756596505642, 0.030646752566099167, 0.01587476208806038, -0.013066545128822327, -0.006501215044409037, 0.007... |
137 | LLY | 2017 | The failure or inadequacy of our IT systems, the compromise, loss, theft, destruction, or unauthorized disclosure or use of confidential information, or the unauthorized access to, disruption of, or interference with our products and services that rely on IT systems, could impair our ability to secure and maintain inte... | [-0.007971227169036865, -0.018112290650606155, 0.015279809013009071, -0.04170764237642288, -0.012798139825463295, 0.029000453650951385, -0.02002226747572422, -0.006467283237725496, 0.027597205713391304, -0.019125746563076973, 0.013174937106668949, 0.01781345158815384, 0.0007105565746314824, 0.0016955910250544548, -0.00... |
138 | LLY | 2017 | To date, system inadequacies, operating failures, unauthorized access, service interruptions or failures, security breaches, malicious intrusions, cyber-attacks, and the compromise, loss, theft, destruction, or unauthorized disclosure or use of confidential information have not had a material impact on our consolidated... | [-0.026769839227199554, -0.024565264582633972, 0.00725016463547945, -0.025693796575069427, -0.011475600302219391, 0.02713726833462715, -0.01850268244743347, -0.021166544407606125, 0.0030263697262853384, -0.016547435894608498, 0.015471392311155796, 0.024250324815511703, -0.007899726741015911, 0.0005835398333147168, 0.00... |
139 | LLY | 2017 | •Significant economic downturns could adversely affect our business and operating results. | [-0.029815759509801865, -0.031927499920129776, 0.030318554490804672, -0.03205319866538048, -0.014794751070439816, 0.01602659933269024, -0.012657871469855309, 0.0069134351797401905, 0.01890510320663452, -0.010049620643258095, 0.005807285662740469, 0.04743873327970505, -0.00326188444159925, 0.005747578572481871, -0.00175... |
140 | LLY | 2017 | While human pharmaceuticals and companion animal health products have not generally been sensitive to overall economic cycles, prolonged economic slowdowns could lead to decreased utilization of our products, affecting our sales volume. Our food animal business may be affected by depressed prices for our customers’ end... | [-0.015234557911753654, -0.03322698175907135, 0.002993212779983878, -0.01736925169825554, -0.01650741882622242, 0.01907965913414955, 0.006679206620901823, -0.0027412923518568277, -0.0190531425178051, -0.014120804145932198, 0.008339893072843552, 0.023242976516485214, 0.0046174367889761925, 0.001208223751746118, -0.00478... |
141 | LLY | 2017 | •Pharmaceutical products can develop unexpected safety or efficacy concerns, which could have a material adverse effect on revenues and income. | [-0.0005947307799942791, -0.028321586549282074, 0.015243146568536758, -0.020397210493683815, -0.00394930224865675, 0.01568124257028103, -0.0020873963367193937, -0.0035949600860476494, -0.006133337039500475, 0.005965829826891422, 0.022845391184091568, 0.01660897396504879, 0.003417789237573743, 0.01756247505545616, -0.00... |
142 | LLY | 2017 | Human pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of limited duration. After approval, the products are used for longer periods of time by much larger numbers of patients; we and others (including regulatory agencies and private payers) collect extensive info... | [0.007502858992666006, -0.017515476793050766, -0.003424500348046422, -0.02414652518928051, -0.024780569598078728, 0.026907259598374367, 0.005207750014960766, 0.023670991882681847, -0.024542802944779396, -0.005131796933710575, 0.00814350787550211, -0.009979594498872757, -0.008955877274274826, 0.0010270198108628392, -0.0... |
143 | LLY | 2017 | •We face many product liability claims and are self-insured; we could face large numbers of claims in the future, which could adversely affect our business. | [-0.0014266874641180038, -0.018437691032886505, -0.00284851947799325, -0.025429511442780495, -0.01979721151292324, 0.019538255408406258, -0.006784655619412661, 0.029650498181581497, 0.01610708236694336, 0.003631862346082926, -0.0037160231731832027, 0.025584883987903595, 0.0035703603643924, -0.008066489361226559, 0.0121... |
144 | LLY | 2017 | We are subject to a substantial number of product liability claims involving Actos®, Axiron®, Byetta®, Cialis, Cymbalta, and Prozac among other products. See Item 8, “Financial Statements and Supplementary Data - Note 15, Contingencies,” and Item 3, “Legal Proceedings,” for more information on our current product liabi... | [-0.002301801461726427, -0.02368895895779133, 0.008084538392722607, -0.021124757826328278, -0.012508779764175415, 0.028591496869921684, -0.018374554812908173, 0.024911271408200264, -0.002404768019914627, -0.010628809221088886, 0.010077440179884434, 0.02952151745557785, -0.015783781185746193, 0.012661568820476532, 0.001... |
145 | LLY | 2017 | •Regulatory compliance problems could be damaging to the company. | [0.008082104846835136, -0.020103497430682182, 0.007123544812202454, -0.021127711981534958, -0.01149615366011858, 0.017332864925265312, -0.018015673384070396, -0.014378398656845093, 0.0060829161666333675, -0.01825203187763691, 0.010892129503190517, 0.010445676743984222, 0.01638743467628956, 0.00020373502047732472, 0.011... |
146 | LLY | 2017 | The marketing, promotional, and pricing practices of human pharmaceutical manufacturers, as well as the manner in which manufacturers interact with purchasers, prescribers, and patients, are subject to extensive regulation. Many companies, including us, have been subject to claims related to these practices asserted by... | [0.01597023196518421, -0.01885594241321087, 8.878870721673593e-05, -0.021056460216641426, -0.02262449450790882, 0.028145557269454002, 0.013848774135112762, 0.022808970883488655, -0.022808970883488655, -0.013380998745560646, 0.0022779321298003197, 0.007042977958917618, -0.013677475973963737, -0.004914931021630764, -0.00... |
147 | LLY | 2017 | •Manufacturing difficulties or disruptions could lead to product supply problems. | [-0.008633793331682682, -0.021819237619638443, -0.009051136672496796, -0.010192310437560081, -0.01484177727252245, 0.0076034762896597385, -0.017476258799433708, 0.014580938033759594, -0.014463559724390507, -0.021101929247379303, 0.0004980407538823783, 0.03748266026377678, 0.004375585354864597, -0.007016587071120739, -0... |
148 | LLY | 2017 | Pharmaceutical and animal health manufacturing is complex and highly regulated. Manufacturing difficulties at our facilities or contracted facilities, or the failure or refusal of a contract manufacturer to supply contracted quantities, could result in product shortages, leading to lost revenue. Such difficulties or di... | [0.01267932914197445, -0.016704831272363663, -0.014561468735337257, -0.004534551408141851, -0.017548780888319016, 0.027234099805355072, -0.009450889192521572, 0.014775805175304413, -0.023818114772439003, -0.010904356837272644, 0.0009770719334483147, 0.02133985236287117, -0.005629675462841988, 2.985323044413235e-05, -0.... |
149 | LLY | 2017 | •Reliance on third-party relationships and outsourcing arrangements could adversely affect our business. | [-0.00839290115982294, -0.025205137208104134, 0.007976559922099113, -0.018332211300730705, -0.014367060735821724, 0.032805006951093674, -0.008577940985560417, 0.0034926363732665777, 0.023513339459896088, -0.00928505975753069, 0.013256818056106567, 0.02717449516057968, 0.004176624584943056, -0.011161897331476212, -0.000... |
150 | LLY | 2017 | We utilize third parties, including suppliers, distributors, alliances with other pharmaceutical and biotechnology companies, and third-party service providers, for selected aspects of product development, manufacture, commercialization, support for information technology systems, product distribution, and certain fina... | [0.004374849610030651, -0.0009905319893732667, -0.0038498674985021353, -0.01303540077060461, -0.014276867732405663, 0.04751912131905556, 0.006587037350982428, 0.013042003847658634, 0.014752322807908058, -0.003214276162907481, 0.005764896050095558, 0.0229803416877985, -0.0013504251837730408, -0.005348872393369675, 0.003... |
151 | LLY | 2017 | •Our animal health segment faces risks related to increased generic competition, food and animal safety concerns, factors affecting global agricultural markets, and other risks. | [0.0072572315111756325, -0.027965310961008072, 0.006323324982076883, -0.01336005050688982, -0.021804122254252434, 0.01885972172021866, -0.004877067171037197, 0.007043211255222559, 0.0029670987278223038, -0.008366245776414871, -0.0107010118663311, 0.02866574004292488, -0.005866100080311298, -0.027187054976820946, 0.0162... |
152 | LLY | 2017 | The animal health operating segment may be impacted by, among other things, emerging restrictions and bans on the use of antibacterials in food-producing animals; perceived adverse effects on human health linked to the consumption of food derived from animals that utilize our products; increased regulation or decreased... | [-0.007820907048881054, -0.028692083433270454, -0.0054607512429356575, -0.015231926925480366, -0.02352222055196762, 0.019092796370387077, -0.011708221398293972, -0.0012544522760435939, -0.014279930852353573, -0.00395673094317317, -0.008177905343472958, 0.01250155083835125, -0.013308102265000343, -0.01565503515303135, 0... |
153 | LLY | 2017 | None. | [-0.00039173135883174837, 0.0027664112858474255, 0.03036193549633026, -0.0021589112002402544, 0.0011439616791903973, 0.015677418559789658, -0.005353185348212719, -0.032452259212732315, -0.002665161155164242, -0.026246612891554832, -0.00082959677092731, 0.012156532146036625, -0.0062513709999620914, -0.011333467438817024... |
154 | LLY | 2017 | Item 7.Management’s Discussion and Analysis of Results of Operations and Financial Condition | [-0.027140120044350624, 0.00868852250277996, -0.02362786792218685, -0.031364645808935165, -0.01117534376680851, 0.006735907401889563, -0.025224346667528152, -0.010751662775874138, -0.00292124692350626, -0.003048658138141036, -0.011046397499740124, 0.027434853836894035, -0.011377973482012749, 0.009726232849061489, -0.00... |
155 | LLY | 2017 | Management’s discussion and analysis of results of operations and financial condition, is intended to assist the reader in understanding and assessing significant changes and trends related to the results of operations and financial position of our consolidated company. This discussion and analysis should be read in co... | [-0.02914224937558174, -0.006415644660592079, -0.009978470392525196, -0.027683857828378677, -0.011117039248347282, 0.015517800115048885, -0.030882084742188454, 0.0037898996379226446, -0.010317482054233551, -0.01356048509478569, 0.003310165600851178, 0.03551311790943146, -0.02072451449930668, 0.004032964818179607, -0.01... |
156 | LLY | 2017 | This section provides an overview of our financial results, recent product and late-stage pipeline developments, and other matters affecting our company and the pharmaceutical industry. Earnings (loss) per share (EPS) data are presented on a diluted basis. | [-0.008215908892452717, -0.008873442187905312, -0.0033283547963947058, -0.043670617043972015, -0.006327942945063114, 0.00472317123785615, -0.0032014052849262953, 0.01661410555243492, -0.004501823335886002, -0.012870723381638527, 0.00932264793664217, 0.03265530988574028, -0.007766703609377146, 0.008079194463789463, -0.0... |
157 | LLY | 2017 | (1) Operating expense consists of research and development and marketing, selling, and administrative expenses. | [-0.004308328032493591, -0.002782786963507533, -0.011630302295088768, -0.02760324999690056, -0.009253078140318394, -0.0012580256443470716, 0.005475101992487907, 0.002558167325332761, -0.006582601461559534, -0.015423877164721489, 0.013726751320064068, 0.03883422911167145, -0.002578445477411151, 0.00479188421741128, -0.0... |
158 | LLY | 2017 | Revenue and gross margin increased in 2017. The increase in operating expense in 2017 was primarily due to an increase in marketing, selling, and administrative expense. Income before income taxes decreased in 2017 as higher asset impairment, restructuring, and other special charges, acquired in-process research and de... | [-0.020507456734776497, -0.0062762112356722355, -0.006118014920502901, -0.019513076171278954, -0.01231997087597847, -0.008936498314142227, 0.00809708796441555, -0.0014520195545628667, -0.007974404841661453, -0.02628002129495144, 0.03076118417084217, 0.021656803786754608, 0.005246318876743317, 0.005007409490644932, 0.00... |
159 | LLY | 2017 | •We recognized acquired IPR&D charges of $1.11 billion (pretax), or $0.97 per share, primarily related to the acquisition of CoLucid Pharmaceuticals, Inc. (CoLucid). | [0.011034063063561916, 0.0028718796093016863, 0.025814056396484375, -0.037459298968315125, 0.01912395842373371, -0.005628752522170544, -0.004662696737796068, 0.002865307731553912, -0.009036234579980373, 0.013774506747722626, 0.018506208434700966, 0.02941540628671646, 0.02022802084684372, 0.0006612880388274789, 0.010179... |
160 | LLY | 2017 | •We recognized charges of $1.67 billion (pretax), or $1.23 per share, primarily associated with efforts to reduce our cost structure, including the U.S. voluntary early retirement program. | [-0.000939303427003324, -0.017092401161789894, -0.0009944611229002476, -0.03950589895248413, -0.0014405896654352546, 0.001779647427611053, -0.015444159507751465, -0.0003106677031610161, -0.010992608033120632, 0.002684882842004299, 0.005791559815406799, 0.03353589028120041, -0.0008204709738492966, 0.0026978610549122095,... |
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